Tec5500 Om e

Defibrillator
TEC-5521/TEC-5531
TEC-5500 series TEC-5521B TEC-5521E TEC-5521K TEC-5531B TEC-5531E TEC-5531K
If you have any comments or suggestions on this manual, please contact us at: www.nihonkohden.com
0614-008784E
Trademark
The mark printed on the holter card and SD card adapter that are used in this instrument is a trademark. The company name and model name are trademarks and registered trademarks of each company.
CONTENTS
Contents
GENERAL HANDLING PRECAUTIONS ................................................................................... i WARRANTY POLICY .............................................................................................................. ii EMC RELATED CAUTION ...................................................................................................... iii Conventions Used in this Manual and Instrument ................................................................... v Warnings, Cautions and Notes ......................................................................................v Explanations of the Symbols in this Manual and Instrument ........................................ vi
Section 1
General .................................................................................. 1C.1

Introduction .......................................................................................................................... 1.1 Models and Functions ................................................................................................ 1.1 Features ..................................................................................................................... 1.2 Composition ......................................................................................................................... 1.3 Caution Label and Caution Mark ........................................................................................... 1.4 Panel Description ................................................................................................................. 1.5 Front Panel ................................................................................................................. 1.5 Top Panel (only for TEC-5531) .................................................................................... 1.6 External Paddles ........................................................................................................ 1.7 Left Side Panel ........................................................................................................... 1.7 Rear Panel ................................................................................................................. 1.8 Important Safety Information ................................................................................................. 1.9 Recording Sound ................................................................................................................ 1.27
Section 2
Preparation ........................................................................... 2C.1

Location ................................................................................................................................ 2.1 Power ................................................................................................................................... 2.2 AC Operation ............................................................................................................. 2.2 Battery Operation ....................................................................................................... 2.2 Using AC Power ................................................................................................................... 2.3 Connecting the Power Cord ........................................................................................ 2.3 Using the Battery ................................................................................................................. 2.4 Safety Information about Battery Pack ....................................................................... 2.4 Checking the Battery Pack .............................................................................. 2.6 Storage ............................................................................................................ 2.6 Disposal ........................................................................................................... 2.6 Inserting the Battery into the Defibrillator ................................................................... 2.7 Charging the Battery Pack ......................................................................................... 2.8 Trickle Charging .......................................................................................................... 2.9 Remaining Battery Power Display ............................................................................ 2.10 Loading the Recording Paper .............................................................................................. 2.11 Basic Checks ..................................................................................................................... 2.12 Displaying the Basic Checks Screen ....................................................................... 2.12 Check Procedure ...................................................................................................... 2.12 Check Before Use .............................................................................................................. 2.15
Operator's Manual TEC-5500
C.1
CONTENTS Before Turning On the Power .................................................................................... 2.15 Check Items After Turning the Power On .................................................................. 2.15
Section 3
System Setup Screen and Setup Screen .......................... 3C.1

System Setup Screen .......................................................................................................... 3.2 How to Change the Items on the System Setup Screen ............................................ 3.2 Configuration .............................................................................................................. 3.3 Setting List....................................................................................................... 3.4 Setting Description ........................................................................................... 3.6 Battery Test .............................................................................................................. 3.12 HV Capacitor Test .................................................................................................... 3.12 Recorder Check ....................................................................................................... 3.12 System Information .................................................................................................. 3.12 Report History .......................................................................................................... 3.12 Use Voice File .......................................................................................................... 3.13 Setup Screen ..................................................................................................................... 3.14 Setup Item List ........................................................................................................ 3.14 How to Change the Settings on the Setup Screen ................................................... 3.15 Paddle Setup ............................................................................................................ 3.16 ECG Setup ............................................................................................................... 3.16 SpO2 Setup .............................................................................................................. 3.16 CO2 Setup ................................................................................................................ 3.16 Report Setup ............................................................................................................ 3.16 Recorder Setup ........................................................................................................ 3.16 Date/Screen ............................................................................................................. 3.16 Date and Time ................................................................................................ 3.16 2nd Wave ....................................................................................................... 3.17 QRS Setup ............................................................................................................... 3.17 Alarm Setup ............................................................................................................. 3.17 Save Report ............................................................................................................. 3.18
Section 4
Defibrillation, Synchronized Cardioversion and AED ..... 4C.1

General About Defibrillation, Synchronized Cardioversion and AED ............................................... 4.0.1 Skin-Paddle Contact Impedance ....................................................................................... 4.0.2 Using the Pediatric Electrode Plate ................................................................................... 4.0.3 Changing Paddle Settings .................................................................................................. 4.0.4 Turning Synchronized Cardioversion With PADDLE Lead On/Off ............................. 4.0.4 Turning Heart Rate Alarm with PADDLE Lead On/Off .............................................. 4.0.5 Using the ECG Waveforms from Another Monitor, Paddles or Disposable Pads for Synchronized Cardioversion .............................................................................................. 4.0.6 ECG Input from Another Monitor ............................................................................. 4.0.6 ECG Input from External Paddles, Internal Paddles and Disposable Pads .............. 4.0.8 Defibrillation Defibrillation Screen .......................................................................................................... 4.1.1 Defibrillation with External Paddles .................................................................................... 4.1.2
C.2
CONTENTS Important Safety Information .................................................................................... 4.1.2 Procedure ................................................................................................................ 4.1.3 Defibrillation with Disposable Pads .................................................................................... 4.1.8 Important Safety Information .................................................................................. 4.1.8 Procedure ................................................................................................................ 4.1.9 Defibrillation with Internal Paddles ................................................................................... 4.1.15 Important Safety Information ................................................................................ 4.1.15 Procedure .............................................................................................................. 4.1.16 Synchronized Cardioversion Synchronized Cardioversion Screen .................................................................................. 4.2.1 Synchronized Cardioversion with External Paddles ........................................................... 4.2.2 Important Safety Information .................................................................................. 4.2.2 Procedure ................................................................................................................ 4.2.3 Synchronized Cardioversion with Disposable Pads ........................................................... 4.2.9 Important Safety Information .................................................................................... 4.2.9 Procedure .............................................................................................................. 4.2.11 Synchronized Cardioversion with Internal Paddles ........................................................... 4.2.17 Important Safety Information ................................................................................ 4.2.17 Procedure .............................................................................................................. 4.2.18 AED AED Screen ...................................................................................................................... 4.3.1 Important Safety Information ............................................................................................ 4.3.2 AED Flowchart .................................................................................................................. 4.3.4 Preparation for AED Mode ....................................................................................... 4.3.5 AED Procedure ................................................................................................................. 4.3.6 When Nonshockable Rhythm Is Detected In AED Analysis .................................. 4.3.15
Section 5
Pacing .................................................................................... 5C.1

About Pacing ........................................................................................................................ 5.1 Important Safety Information ............................................................................................... 5.2 Pacing in Fixed Mode ........................................................................................................... 5.3 Information on the Pacing Screen in Fixed Mode ....................................................... 5.3 Procedure ................................................................................................................... 5.4 Pacing in DEMAND mode .................................................................................................. 5.11 Information on the Pacing Screen in DEMAND Mode ............................................... 5.11 Procedure ................................................................................................................. 5.12
Section 6
Monitoring ............................................................................. 6C.1

General .............................................................................................................................. 6.0.1 Displaying the Monitoring Screen ............................................................................ 6.0.1 Screen Examples .................................................................................................... 6.0.1 ECG Monitoring Preparing for ECG Monitoring ............................................................................................ 6.1.2 Preparation Flowchart ............................................................................................. 6.1.2
C.3
CONTENTS Selecting a Lead ..................................................................................................... 6.1.2 Number of Electrodes and Measuring Leads ........................................................... 6.1.3 Electrode Position ................................................................................................... 6.1.3 3 Electrode Leads ......................................................................................... 6.1.3 5 Electrode Leads ......................................................................................... 6.1.4 Selecting Electrodes and Lead ................................................................................ 6.1.5 Types of Electrodes and Lead ....................................................................... 6.1.5 Connecting the ECG Connection Cable or the JC-762V/JC763V Connection Cable to the Defibrillator ........................................................................................................ 6.1.6 Connecting the ECG Connection Cable to the Defibrillator ............................ 6.1.6 Connecting the JC-762V/JC763V Connection Cable to the Defibrillator ........ 6.1.6 Attaching Disposable ECG Electrodes to the Patient .............................................. 6.1.7 Monitoring ECG with Disposable Pads .................................................................... 6.1.8 Monitoring ECG ................................................................................................................. 6.1.9 ECG Information on the Monitoring Screen ............................................................. 6.1.9 Selecting an ECG Lead ................................................................................................... 6.1.10 Selecting ECG Sensitivity ............................................................................................... 6.1.11 AUTO .......................................................................................................... 6.1.11 Changing ECG Settings .................................................................................................. 6.1.12 Changing Settings on the ECG Setup Screen ....................................................... 6.1.12 Turning the AC Hum Filter On/Off .......................................................................... 6.1.13 Changing the Time Constant Setting ..................................................................... 6.1.14 Turning Pacing Pulse Rejection On/Off .................................................................. 6.1.15 Changing Heart Rate Upper/Lower Limit ................................................................ 6.1.16 Changing Settings on the QRS Setup Screen ....................................................... 6.1.17 Changing QRS Sync Sound Volume ...................................................................... 6.1.18 Changing QRS Sync Sound Source ...................................................................... 6.1.18 Turning the VF/VT Alarm On or Off ....................................................................... 6.1.19 Use with an Electrosurgical Unit ...................................................................................... 6.1.20 SpO2 monitoring General .............................................................................................................................. 6.2.1 Preparing for SpO2 Monitoring ............................................................................................ 6.2.3 Preparation Flowchart .............................................................................................. 6.2.3 Selecting a Probe .................................................................................................... 6.2.3 Reusable Probes ........................................................................................... 6.2.4 Disposable Probes ........................................................................................ 6.2.5 Attaching the Probe to the Patient .......................................................................... 6.2.6 Connecting Probe to Defibrillator ............................................................................. 6.2.6 Monitoring SpO2 ..................................................................................................................................................................................................... 6.2.8 SpO2 Information on the Monitoring Screen ............................................................. 6.2.8 Changing SpO2 Settings .................................................................................................... 6.2.9 Changing Settings on the SpO2 Setup Screen ......................................................... 6.2.9 Changing the Pulse Waveform Sensitivity .............................................................. 6.2.10 Selecting Sync Sound Pitch ................................................................................. 6.2.11 Changing the Pulse Rate Alarm Limits ................................................................. 6.2.12 Changing the SpO2 Alarm Limits ........................................................................... 6.2.13 Changing QRS Sync Sound Volume ..................................................................... 6.2.13 Changing QRS Sync Sound Source ...................................................................... 6.2.13
C.4
CONTENTS CO2 monitoring General .............................................................................................................................. 6.3.1 CO2 Sensor Kit ........................................................................................................ 6.3.3 Preparing for CO2 Monitoring ............................................................................................. 6.3.6 Preparation Flowchart .............................................................................................. 6.3.6 Connecting the CO2 Sensor Kit to the Defibrillator ................................................... 6.3.6 Monitoring CO2 ........................................................................................................................................................................................................ 6.3.7 CO2 Information on the Monitoring Screen ............................................................... 6.3.7 Changing CO2 Settings ...................................................................................................... 6.3.8 Changing Settings on the CO2 Setup Screen .......................................................... 6.3.8 Changing the CO2 Scale .......................................................................................... 6.3.9 Changing the etCO2 Alarm Limits .......................................................................... 6.3.10 Changing the Respiration Rate Alarm Limits ......................................................... 6.3.11 Changing the APNEA Alarm Limit .......................................................................... 6.3.12 Inspection of Measuring Accuracy ................................................................................... 6.3.13 Daily Inspection of Measuring Accuracy ................................................................ 6.3.13 Inspection of Measuring Accuracy (Precise Method) ............................................. 6.3.13 Checking Procedure .................................................................................... 6.3.14
Section 7
Alarm Function ..................................................................... 7C.1

General ................................................................................................................................. 7.1 Alarm Types ............................................................................................................... 7.1 Alarm Indication ......................................................................................................... 7.1 Alarm List ................................................................................................................... 7.2 Alarm Status Marks and Messages ........................................................................... 7.4 Temporarily Silencing an Alarm After It Occurs .................................................................... 7.5 Silencing Alarms ........................................................................................................ 7.5 Resuming Alarms ....................................................................................................... 7.5 Suspending an Alarm Before It Occurs ................................................................................ 7.6 Suspending Alarms .................................................................................................... 7.6 Automatic Alarm Recording .................................................................................................. 7.6 Setting Alarms ..................................................................................................................... 7.7 Alarm Setting Range .................................................................................................. 7.7 Setting Alarm Settings on the Alarm Setup Screen .................................................... 7.8 Setting Alarm Settings on the Alarm Setup Screen of the Setup Screen ................... 7.9 Setting Alarms Individually ....................................................................................... 7.10
Section 8
Recording ............................................................................. 8C.1

About Recording ................................................................................................................... 8.1 Changing Report and Recorder Settings ............................................................................... 8.3 Manual Recording ................................................................................................................. 8.4 Real Time or Delayed Waveform Recording ................................................................ 8.4 Procedure ........................................................................................................ 8.4 Report Recording ....................................................................................................... 8.5 Periodic List Report Recording ......................................................................... 8.5 Alarm Report Recording ................................................................................... 8.5 Event List Report Recording ............................................................................ 8.6
C.5
CONTENTS Defibrillation Report Recording ......................................................................... 8.8 VF Analysis Report Recording ......................................................................... 8.9 Trend Report Recording .................................................................................. 8.10 Event Recording ....................................................................................................... 8.11 Saving the Administered Medication ........................................................................ 8.12 Automatic Recording .......................................................................................................... 8.13 Record On Charging After Discharge ........................................................................ 8.13 Alarm Recording ....................................................................................................... 8.14 Periodic Recording ................................................................................................... 8.15 Printed Letters and Marks .................................................................................................. 8.16
Section 9
Messages and Troubleshooting ......................................... 9C.1

Messages ............................................................................................................................. 9.2 Troubleshooting .................................................................................................................. 9.10 General ..................................................................................................................... 9.10 Defibrillation .............................................................................................................. 9.11 Pacing (TEC-5531 Series Only) ................................................................................ 9.11 Monitoring ................................................................................................................ 9.12 ECG ............................................................................................................... 9.12 SpO2 ................................................................................................................................................................................................. 9.13 CO2 ..................................................................................................................................................................................................... 9.14 Recording ................................................................................................................. 9.15 Battery ..................................................................................................................... 9.16 SD Card ................................................................................................................... 9.16
Section 10 Maintenance ....................................................................... 10C.1

Cleaning, Disinfecting and Sterilization .............................................................................. 10.1 Defibrillator ............................................................................................................... 10.1 External Paddles ...................................................................................................... 10.1 Internal Paddles ....................................................................................................... 10.2 Battery ..................................................................................................................... 10.2 ECG Electrode Leads and ECG Connection Cable .................................................. 10.3 Disposal and Replacement ................................................................................................. 10.4 Battery ..................................................................................................................... 10.4 Disposal of Battery Pack ................................................................................ 10.4 Replacing Battery Pack .................................................................................. 10.4 Disposable Pads ...................................................................................................... 10.6 Lifetime .......................................................................................................... 10.6 Disposal ......................................................................................................... 10.6 ECG ......................................................................................................................... 10.6 Electrode Lifetime .......................................................................................... 10.6 Disposing of Electrodes ................................................................................. 10.6 Check After Use ................................................................................................................. 10.7 Periodical Checks ............................................................................................................... 10.8 Checking External Paddles ...................................................................................... 10.8 Checking 270 J Energy Charge and Disarm ............................................................. 10.9 Battery Test ............................................................................................................ 10.10
C.6
CONTENTS Checking the Battery Appearance .......................................................................... 10.12 HV Capacitor Test .................................................................................................. 10.13 Recorder Test ......................................................................................................... 10.14 Date and Time Adjustment ..................................................................................... 10.14 Periodical Replacement Schedule .................................................................................... 10.14 Repair Parts Availability Policy ......................................................................................... 10.14 Storage ............................................................................................................................. 10.15 Defibrillator and Battery .......................................................................................... 10.15 Short Term Storage (Ready for Use at Any Time) ........................................ 10.15 Long Term Storage ....................................................................................... 10.15 Disposable Pads and ECG Electrodes ................................................................... 10.16
Section 11 Reference ............................................................................ 11C.1

Specifications .................................................................................................................... 11.1 Defibrillator ..................................................................................................... 11.1 Noninvasive Pacing (TEC-5531 series only) .................................................. 11.3 External Paddle (ND-552VB/VE/VK) .............................................................. 11.3 Battery ........................................................................................................... 11.3 Clock Accuracy .............................................................................................. 11.3 Environment ................................................................................................... 11.3 Safety ............................................................................................................ 11.4 Monitor ........................................................................................................... 11.4 ECG Amplifier ................................................................................................ 11.4 Recorder ......................................................................................................... 11.5 Rhythm Recognition Detector ........................................................................ 11.5 Power Requirements ...................................................................................... 11.5 Dimensions and Weight .................................................................................. 11.5 Electromagnetic Compatibility ........................................................................ 11.6 Reference ......................................................................................................................... 11.10 Standard Accessories ...................................................................................................... 11.11 Options/Consumables ...................................................................................................... 11.12 Pin Assignment ................................................................................................................ 11.14 AUX Connector of the QI-553V DSI/AUX OUT Interface Unit ................................. 11.14 General Requirements for Connecting Medical Electrical System .................................... 11.15
C.7
CONTENTS
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C.8
GENERAL HANDLING PRECAUTIONS This device is intended for use only by qualified medical personnel. Use only Nihon Kohden approved products with this device. Use of non-approved products or in a non-approved manner may affect the performance specifications of the device. This includes, but is not limited to, batteries, recording paper, pens, extension cables, electrode leads, input boxes and AC power.
Please read these precautions thoroughly before attempting to operate the instrument. 1. To safely and effectively use the instrument, its operation must be fully understood. 2. When installing or storing the instrument, take the following precautions: (1) Avoid moisture or contact with water, extreme atmospheric pressure, excessive humidity and temperatures, poorly ventilated areas, and dust, saline or sulphuric air. (2) Place the instrument on an even, level floor. Avoid vibration and mechanical shock, even during transport. (3) Avoid placing in an area where chemicals are stored or where there is danger of gas leakage. (4) The power line source to be applied to the instrument must correspond in frequency and voltage to product specifications, and have sufficient current capacity. (5) Choose a room where a proper grounding facility is available. 3. Before Operation (1) Check that the instrument is in perfect operating order. (2) Check that the instrument is grounded properly. (3) Check that all cords are connected properly. (4) Pay extra attention when the instrument is in combination with other instruments to avoid misdiagnosis or other problems. (5) All circuitry used for direct patient connection must be doubly checked. (6) Check that battery level is acceptable and battery condition is good when using battery-operated models. 4. During Operation (1) Both the instrument and the patient must receive continual, careful attention. (2) Turn power off or remove electrodes and/or transducers when necessary to assure the patients safety. (3) Avoid direct contact between the instrument housing and the patient. 5. To Shutdown After Use (1) Turn power off with all controls returned to their original positions. (2) Remove the cords gently; do not use force to remove them. (3) Clean the instrument together with all accessories for their next use. 6. The instrument must receive expert, professional attention for maintenance and repairs. When the instrument is not functioning properly, it should be clearly marked to prevent use while it is out of order. 7. The instrument must not be altered or modified in any way. 8. Maintenance and Inspection (1) The instrument and parts must undergo regular maintenance inspection at least every 6 months. (2) If stored for extended periods without being used, make sure prior to operation that the instrument is in perfect operating condition.
(3) Technical information such as parts list, descriptions, calibration instructions or other information is available for qualified user technical personnel upon request from your Nihon Kohden distributor. 9. When the instrument is used with an electrosurgical instrument, pay careful attention to the application and/or location of electrodes and/or transducers to avoid possible burn to the patient.
WARRANTY POLICY
Nihon Kohden Corporation (NKC) shall warrant its products against all defects in materials and workmanship for one year from the date of delivery. However, consumable materials such as recording paper, ink, stylus and battery are excluded from the warranty. NKC or its authorized agents will repair or replace any products which prove to be defective during the warranty period, provided these products are used as prescribed by the operating instructions given in the operators and service manuals. No other party is authorized to make any warranty or assume liability for NKCs products. NKC will not recognize any other warranty, either implied or in writing. In addition, service, technical modification or any other product change performed by someone other than NKC or its authorized agents without prior consent of NKC may be cause for voiding this warranty. Defective products or parts must be returned to NKC or its authorized agents, along with an explanation of the failure. Shipping costs must be pre-paid. This warranty does not apply to products that have been modified, disassembled, reinstalled or repaired without Nihon Kohden approval or which have been subjected to neglect or accident, damage due to accident, fire, lightning, vandalism, water or other casualty, improper installation or application, or on which the original identification marks have been removed. In the USA and Canada other warranty policies may apply.
CAUTION
United States law restricts this device to sale by or on the order of a physician.
ii
EMC RELATED CAUTION

This equipment and/or system complies with IEC 60601-1-2 International Standard for electromagnetic compatibility for medical electrical equipment and/or system. However, an electromagnetic environment that exceeds the limits or levels stipulated in IEC 60601-1-2, can cause harmful interference to the equipment and/or system or cause the equipment and/or system to fail to perform its intended function or degrade its intended performance. Therefore, during the operation of the equipment and/or system, if there is any undesired deviation from its intended operational performance, you must avoid, identify and resolve the adverse electromagnetic effect before continuing to use the equipment and/or system. The following describes some common interference sources and remedial actions: 1. Strong electromagnetic interference from a nearby emitter source such as an authorized radio station or cellular phone: Install the equipment and/or system at another location. Keep the emitter source such as cellular phone away from the equipment and/or system, or turn off the cellular phone. 2. Radio-frequency interference from other equipment through the AC power supply of the equipment and/ or system: Identify the cause of this interference and if possible remove this interference source. If this is not possible, use a different power supply. 3. Effect of direct or indirect electrostatic discharge: Make sure all users and patients in contact with the equipment and/or system are free from direct or indirect electrostatic energy before using it. A humid room can help lessen this problem. 4. Electromagnetic interference with any radio wave receiver such as radio or television: If the equipment and/or system interferes with any radio wave receiver, locate the equipment and/or system as far as possible from the radio wave receiver. 5. Interference of lightning When lightning occurs near the location where the equipment and/or system is installed, it may induce an excessive voltage in the equipment and/or system. In such a case, disconnect the AC power cord from the equipment and/or system and operate the equipment and/or system by battery power, or use an uninterruptible power supply. 6. Use with other equipment When the equipment and/or system is adjacent to or stacked with other equipment, the equipment and/ or system may affect the other equipment. Before use, check that the equipment and/or system operates normally with the other equipment. 7. Use of unspecified accessory, transducer and/or cable When an unspecified accessory, transducer and/or cable is connected to this equipment and/or system, it may cause increased electromagnetic emission or decreased electromagnetic immunity. The specified configuration of this equipment and/or system complies with the electromagnetic requirements with the specified configuration. Only use this equipment and/or system with the specified configuration.
iii
Caution - continued 8. Use of unspecified configuration When the equipment and/or system is used with the unspecified system configuration different than the configuration of EMC testing, it may cause increased electromagnetic emission or decreased electromagnetic immunity. Only use this equipment and/or system with the specified configuration. 9. Measurement with excessive sensitivity The equipment and/or system is designed to measure bioelectrical signals with a specified sensitivity. If the equipment and/or system is used with excessive sensitivity, artifact may appear by electromagnetic interference and this may cause mis-diagnosis. When unexpected artifact appears, inspect the surrounding electromagnetic conditions and remove this artifact source. If the above suggested remedial actions do not solve the problem, consult your Nihon Kohden distributor or representative for additional suggestions.
For EMC compliance, refer to Specification - Electromagnetic Compatibility in the Reference section
The CE mark is a protected conformity mark of the European Community. The products herewith comply with the requirements of the Medical Device Directive 93/42/EEC.
NOTE about Waste Electrical and Electronic Equipment (WEEE) directive 2002/96/EEC For the member states of the European Union only: The purpose of WEEE directive 2002/96/EEC is, as a first priority, the prevention of waste electrical and electronic equipment (WEEE), and in addition, the reuse, recycling and other forms of recovery of such wastes so as to reduce the disposal of waste. Contact your Nihon Kohden representative for disposal at the end of its working life.
iv
Conventions Used in this Manual and Instrument Dangers, Warnings, Cautions and Notes
Dangers, Warnings, cautions and notes are used in this manual to alert or signal the reader to specific information.
DANGER
A danger is used to alert the user to a hazardous situation which will cause death or serious injury.
WARNING
A warning alerts the user to the possible injury or death associated with the use or misuse of the instrument.
CAUTION
A caution alerts the user to possible injury or problems with the instrument associated with its use or misuse such as instrument malfunction, instrument failure, damage to the instrument, or damage to other property.
NOTE
A note provides specific information, in the form of recommendations, prerequirements, alternative methods or supplemental information.
Explanations of the Symbols in this Manual and Instrument

The following symbols found in this manual/instrument bear the respective descriptions as given. On main unit
Symbol
Description
Symbol
Description
AC power operation
Output
Charging
Input
Charged (Battery charging is finished)
Dangerous voltage
ECG lead
ECG
ECG sensitivity
Pacing start
Alarm off
Pacing stop
Real time/delayed recording
Attention, consult operators manual
Event recording
Provides ActiBiphasic waveform defibrillation function
Inserting or removing the memory card Defibrillation-proof type BF applied part
IPX1
IPX4
Complies with IEC 60529 IPX1
Defibrillation-proof type CF applied part
IPX7
The CE mark is a protected conformity mark of European Community. The products herewith comply with the requirements of the Medical Device Directive 93/42/EEC.
The products marked with this symbol apply to the European WEEE directive 2002/96/EEC and require separate waste collection. For Nihon Kohden product labeled with this symbol, contact your Nihon Kohden representative for disposal at the end of its working life.
vi
On LCD
Symbol
Description
Symbol
Description
Battery fully charged
Add Z-fold recording paper
More than 2/3 battery charge remains
QRS sync mark
More than 1/3 battery charge remains
The point of implanted pacemaker pulse output
1 3
Battery power for one 270 J charging remains
AC power operation
Battery operation not available
Alarm off
Real time/delayed recording
Event recording
SD card inserted
Cannot write to the SD card
Writing to the SD card
Can eject SD card
ECG cascaded display
Report recording
AED analysis paused
SpO2 pulse wave unstable
CPR start
VF/VT alarm off
vii
viii
Section 1 General
Introduction ......................................................................................................................... 1.1 Models and Functions ............................................................................................... 1.1 Features .................................................................................................................... 1.2 Composition ........................................................................................................................ 1.3 Caution Label and Caution Mark .......................................................................................... 1.4 Panel Description ................................................................................................................ 1.5 Front Panel ................................................................................................................ 1.5 Top Panel (only for TEC-5531) ................................................................................... 1.6 External Paddles ....................................................................................................... 1.7 Left Side Panel .......................................................................................................... 1.7 Rear Panel ................................................................................................................ 1.8 Important Safety Information .............................................................................................. 1.9 Recording Sound ............................................................................................................... 1.27
1C.1
1C.2
1. GENERAL
Introduction
This instrument is a portable defibrillator with functions necessary for cardiopulmonary resuscitation treatment by biphasic defibrillation waveform. In AED mode, if the defibrillator detects a shockable rhythm in ECG analysis, it automatically charges energy to prepare for defibrillation (AED function). This helps doctors who are inexperienced in defibrillation to perform defibrillation easily. This defibrillator can use either AC power operation or optional battery operation according to where it is used. With an optional DSI interface unit or DSI/AUX OUT interface unit, SpO2 and CO2 monitoring are available with this defibrillator, which enables continuous monitoring of the patient after defibrillation or cardioversion.
Models and Functions

Functions TEC-5521 TEC-5531
Defibrillation and synchronized cardioversion
External paddles Internal paddles Disposable pads Pediatric electrode assy 44 mm
Standard Option Option Option Standard Standard Not available Option Option Standard Option Option Option Standard Standard
Standard Option Option Option Standard Standard Standard Option Option Standard Option Option Option Standard Standard
3 lead ECG AED function Noninvasive pacing SpO2 measurement CO2 measurement Voice prompt 5 lead ECG External ECG input External ECG output SD card slot Sound recording
1.1
1. GENERAL
Features
1. Biphasic waveform defibrillation The defibrillator provides biphasic waveform defibrillation. Biphasic waveform defibrillation requires low energy than conventional monophasic defibrillation. 2. Display The display is 5.7 inch color LCD. ECG waveforms and messages are easy to see. You can select either 25 or 50 mm/sec for sweep speed. 3. Selectable power sources, AC/ Battery Either AC or battery power can be selected according to where it is used. 4. Fast charging Charges from 0 to 270 J within 5 seconds in both AC and battery operation (with a fully charged new battery at 20C). Charges from 0 to 200 J within 3 seconds in both AC and battery operation. This enables timely defibrillation and cardioversion. 5. Quick ECG waveform recovery After defibrillation or cardioversion the ECG waveform returns within 3 seconds so you can immediately check the result of defibrillation or cardioversion. 6. AED function During ECG analysis, if the defibrillator detects a shockable rhythm, it automatically charges energy to prepare for the next defibrillation. 7. Noninvasive pacing (only for TEC-5531 series defibrillator) The TEC-5531 series defibrillator has noninvasive pacing. This is useful for first aid for bradycardia that often appears after defibrillation. 8. SpO2 and CO2 monitoring With the optional DSI interface unit or DSI/AUX OUT interface unit, SpO2 and CO2 can be monitored on the defibrillator. 9. Voice prompt This function is mainly used in AED mode. Defibrillator status and cautions during defibrillation are directed by voice. 10. Basic function check The defibrillator has a semi-automatic self check function for discharge, battery, recording, alarm sound and voice. These checks are performed on one screen. You can easily check the defibrillator before use. 13. SD card With a specified SD card, report data and surrounding sound together with the ECG waveforms can be recorded and transferred to a personal computer.
1.2
1. GENERAL
Composition
TEC-5500 Series Defibrillator Standard accessories
Name Recording paper (Z-fold) Contact gel GELAID Battery check label (for defibrillator) Qty 1 1 1
Options
Disposable pads P-510
Internal paddles
TG-101T CO2 sensor
Cart KD-028A Cart tray assembly DI-001A
TG-121T CO2 sensor

R TE P E /A R LA R M D A
R TE P A D A O C
2
JG-901T3 CO2 adapter

SpO2 adapter JL-951T3

Name TEC accessory set (100V/IEC)
CO2 sensor kit TG-901T3
CO2 sensor kit TG-921T3
BC-763V ECG connection cable (IEC, 3 leads) + Power cord H TEC accessory set (200V/IEC) BC-763V ECG connection cable (IEC, 3 leads) + Power cord N TEC accessory set (100V/AHA) BC-763VA ECG connection cable (AHA, 3 leads) + Power cord H TEC accessory set (200/AHA) BC-763VA ECG connection cable (AHA, 3 leads) + Power cord N QI-552V DSI interface unit QI-553V DSI/AUXOUT interface unit
HOPER
/A
M R LA
1.3
1. GENERAL
Caution Label and Caution Mark

This indicates cautions labels, caution marks on the instrument and where the related explanations are.
WARNING
Connect only the specified instrument to the defibrillator and follow the specified procedure. Failure to follow this warning may result in electrical shock or injury to the patient and operator, and cause fire or instrument malfunction.
Refer to Section 4 Defibrillation, Synchronized Cardioversion and AED, ECG Monitoring in Section 6 Monitoring and Section 9 Messages and Troubleshooting Refer to Section 5 Pacing Left side panel: Refer to Using the Battery and Loading the Recording Paper in Section 2 Preparation.
Refer to ECG Monitoring in Section 6.
Refer to SpO2 Monitoring and CO2 Monitoring in Section 6 .
Refer to Section 4 Defibrillation, Synchronized Cardioversion and AED
1.4
1. GENERAL
Panel Description
Front Panel
* When DSI interface unit is connected
2 1
3
5 7
8
* When DSI/AUXOUT interface
6 9
unit is connected
10
11
No. 1 2
Name LCD display Energy/Mode Select control
Description Displays monitored waveforms, alarm settings and other settings. Turns the power on/off or selects MONITOR mode, FIXED pacing mode*, DEMAND pacing mode* and defibrillation/cardioversion discharge energy. The control positions are OFF, MONITOR, AED, DISARM, 2, 3, 5, 7, 10, 15, 20, 30, 50, 70, 100, 150, 200, 270 joules, DEMAND*, FIXED*, BASIC CHECK and SETUP. To discharge the charged energy internally, turn to the DISARM position. * Pacing is only available for TEC-5531 series defibrillator. Records the surrounding sound in an SD card. When the SD card is inserted into the defibrillator, recording automatically starts. To stop recording, select the Setup screen, then eject the SD card. Selects synchronized cardioversion mode. When the synchronized cardioversion mode is selected the SYNC lamp lights. To select defibrillation mode, press this key again. Starts to charge the selected energy. When AED mode is selected, starts AED analysis. The defibrillator automatically charges energy when a shockable rhythm is detected. When disposable pads or internal paddles are used, discharges the charged energy. When using external paddles, this button is covered. Blinks when charging completes. When using external paddles, this lamp is covered. Connects to the ECG connection cable. Connects to SpO2 adapter or CO2 sensor kit. You can connect one SpO2 adapter and one CO2 sensor kit at the same time. If two SpO2 adapters or two CO2 sensor kits are connected at the same time, only the measurement with the earlier connected connector is available. If the power is turned on with two SpO2 adapters or two CO2 sensor kits connected, only the measurement with the left connector is available. * Option: When DSI interface unit is connected. Outputs ECG waveforms when the optional DSI/AUXOUT interface unit is connected. Connects to external paddles, internal paddles or pad adaptor.
Microphone
SYNC button/lamp
5 6 7 8 9
CHARGE/AED button DISCHARGE button DISCHARGE lamp ECG input connector SpO2/CO2 connector
10 11
AUXOUT connector Paddle connector
1.5
1. GENERAL
14 12
15
16
17 18 19
13
20
No. 12 13 14 15 16 17
Name Record key Event key ECG lead key ECG sensitivity key Silence alarms key Multi-function key
Description Starts recording with the recorder. To stop recording, press this key again. Starts event recording. When this key is pressed, the recorded waveforms are saved as an event in the summary recording data. Changes ECG leads. Changes ECG sensitivity. Temporarily suspends or silences alarms. In the monitor mode, opens the alarm setup screen. You can confirm or change alarm settings. In AED mode this key changes to Pause key. Lights when AC power is supplied to the defibrillator. Lights when the battery is being charged. Lights when the battery is completely charged.
18 19 20
AC lamp Battery charging lamp Battery charge complete lamp
Top Panel (only for TEC-5531)
No. 1 2 3 4 5 6
Name PACING RATE Up key PACING RATE Down key PACING OUTPUT Up key PACING OUTPUT Down key START/STOP key PULSE lamp
Description Increases the pacing frequency (pulse/minute). Decreases the pacing frequency (pulse/minute). Increases the intensity of the pacing current. Decreases the intensity of the pacing current. Press to start pacing. Pressing this key again stops pacing. Blinks in synchronization with the pacing pulse.
1.6
1. GENERAL
External Paddles
4 1 2 3 4
No. 1 2 3 4
Name CONTACT lamp CHARGE button CHARGE lamp DISCHARGE buttons
Description Indicates the quality of contact between paddles and patient. The GOOD lamp must light. Press to charge the selected energy. Blinks while the selected energy is being charged. Lights when the energy is completely charged. Simultaneously press both buttons to discharge the charged energy. In synchronized cardioversion, the defibrillator discharges energy at the appropriate timing after these buttons are pressed.
Left Side Panel
No. 1 2 3 4
Name Recording paper exit Door release lever SD card slot Battery pack holder
Description The recorded paper comes from this slit. A cutter to cut the paper is attached here. Pull the lever up to open the door. Insert an SD card here. To remove the card, push it in. Contains the battery.
1.7
1. GENERAL
Rear Panel
No. 1 2
Name AC SOURCE socket Optional unit connector
Description Connects the AC power cord to supply AC power. Optional unit is connected. When not used, attach the cover here.
1.8
1. GENERAL
Important Safety Information

General DANGER
Never use the defibrillator in the presence of any flammable anesthetic gas or high concentration oxygen atmosphere. Failure to follow this warning may cause explosion or fire. Never use the defibrillator in a hyperbaric oxygen chamber. Failure to follow this warning may cause explosion or fire.
WARNING
The defibrillator generates high voltage. The defibrillator must only be operated by trained and qualified medical personnel. Radiofrequency or Electromagnetic Field Do not use any kind of non-essential non-patient care device within a radius of 1 meter around the defibrillator. The use of non-essential non-patient care devices that emit radiofrequency or electromagnetic fields may interfere with the operation of the defibrillator by causing noise on the ECG waveform or error messages. If a non-essential non-patient care device is accidentally placed near the defibrillator, quickly remove it. MRI examination - Do not install this defibrillator in an MRI examination room. The defibrillator may not operate properly due to high-frequency magnetic noise from the MRI. - When performing MRI tests, remove all electrodes and transducers from the patient which are connected to this defibrillator. Failure to follow this warning may cause serious electrical burn on the patient due to local heating caused by dielectric electromotive force. For details, refer to the instruction manual for the MRI. Using with ESU - When the defibrillator is used with an electrosurgical unit (ESU), firmly attach the entire area of the ESU return plate. Otherwise, the current from the ESU flows into the electrodes of the defibrillator, causing electrical burn where the electrodes are attached. For details, refer to the ESU manual. - When using an ESU, use this defibrillator only in the MONITOR mode and use the ECG electrodes for monitoring. Do not monitor ECG with disposable pads, external paddles or internal paddles. If ECG is monitored with pads or paddles, high frequency energy from the ESU causes abnormal current to flow in the patient and unexpected discharge. This may damage the defibrillator.
1.9
1. GENERAL
WARNING continued
Surrounding Conditions Fluids such as Ringers saline solution and blood are excellent electrical conductors; to avoid creating potentially dangerous electrical paths, keep the defibrillator and the immediate area clean and dry at all times.
CAUTION
Install the defibrillator and ESU appropriately and perform equipotential grounding. Otherwise, noise from the ESU may be falsely recognized as QRS and ECG monitoring might not be performed properly. Only use Nihon Kohden specified parts and accessories. When other parts or accessories are used, the defibrillator heats up and may be damaged, and monitoring stops. Do not reuse disposable items. Turn off the power of cellular telephones, small wireless devices and other devices which produce strong electromagnetic interference. Otherwise, the waveforms and measurements are affected by interference and the displayed data may be incorrect.
Installation WARNING
Connect only the specified instrument to the defibrillator and follow the specified procedure. Failure to follow this warning may result in electrical shock or injury to the patient and operator, and cause fire or instrument malfunction. Only use the provided power cord. Using other power cords may result in electrical shock or injury to the patient and operator. Only use the provided power cord. When the provided power cord cannot be used or when equipotential grounding is doubtful (such as in poor grounding facility), operate the defibrillator on battery power. Otherwise, the patient and operator may receive electrical shock or injury. When several medical instruments are used together, ground all instruments to the same one-point ground. Any potential difference between instruments may cause electrical shock to the patient and operator. Do not connect several grounding leads directly to the equipotential terminal because the grounding lead may be disconnected from the terminal.
1.10
1. GENERAL
CAUTION
The defibrillator should only be connected to external equipment which complies with the CISPR 11 Second Edition 1990-09, Group 1 and Class B standard. Only use the KD-028A cart for this defibrillator. If another cart is used, it may tip over or the defibrillator may fall off. Assembly and disassembly of any component in the instrument should only be done by qualified service personnel.
Battery DANGER
Keep the battery pack away from fire. Do not heat the battery pack. If the battery pack is heated, the substance inside the battery squirts out and the battery pack explodes. Never connect the + and terminals on the battery pack with a wire. Never store the battery pack with metals such as necklace or hair pins. The battery pack may short-circuit, causing the substance inside the battery to leak or explode. Never disassemble or modify the battery pack. Never damage or directly solder the sheath tube. The battery pack may short-circuit, the substance inside the battery may squirt out and the battery pack may explode. Do not subject the battery pack to a strong shock. The battery may leak and explode. Do not use a battery which is damaged, such as from falling. The battery has a gas discharge valve and if this valve is damaged, the gas cannot be discharged, causing the battery to explode. If the battery pack is damaged and the substance inside the battery (alkaline liquid) contacts the eyes or skin, wash immediately and thoroughly with water and see a physician. Never rub your eyes, because you may lose your eyesight. The battery pack has + and polarity. Make sure that the battery is installed in the correct direction. Do not connect the battery with force if it cannot be connected easily. If the battery is connected with the wrong polarity, the substance inside the battery may leak and explode. Do not charge the battery pack with an instrument other than this defibrillator. With another instrument, abnormal current flows and the battery may leak and explode. Do not connect the battery pack to an AC outlet or lighter socket in a car. The battery may leak and explode.
1.11
1. GENERAL
WARNING
Test the battery once a month. When you start using a new battery pack, write the date of first use on the labels on the battery pack and defibrillator. Replace the battery pack every year. If defibrillation or cardioversion is necessary during the battery test, cancel the battery test and operate the defibrillator on AC power. Do not use battery power because the battery may have been discharged by the battery test. Do not immerse the battery pack in water. The battery heats up and rusts and the substance inside the battery leaks. Never use a battery pack which is damaged, discolored or has leakage. The battery may explode if used. Do not leave the battery unused for more than about one year. The battery may leak.
CAUTION
When inserting or removing the battery, disconnect the power cord from the defibrillator. Otherwise, the operator may receive electrical shock. To keep the battery fully charged, always keep the power cord connected to the AC outlet even when the defibrillator is not used. Otherwise, the battery may discharge and become unusable. Do not expose the battery pack to direct sunlight or leave in a high temperature place. The lifetime of the battery pack may be shortened, the performance of the battery pack may be degraded and the battery may leak. The battery pack must be inserted by a qualified service personnel. Keep the battery pack away from children.
NOTE
Before disposing of the battery, check with your local solid waste officials for details in your area for recycling options or proper disposal. The battery is recyclable. At the end of its useful life, under various state and local laws, it may be illegal to dispose of this battery into the municipal waste stream.
1.12
1. GENERAL
Disposable Pads WARNING

Failure to follow the warnings below may cause skin burn or insufficient energy discharge and insufficient pacing current to the heart. - Do not reuse disposable pads. - If the pad package is torn, dispose of the pads and do not use them. - Do not use the pads if they are past the expiration date on the package. - Use the disposable pads as soon as possible after opening the package. - Do not use the disposable pads if the gel has become dry or if the gel has become abnormal (the gel has become liquid or is coming off the edges of the pad, etc). - Do not use the disposable pads if the gel is dark brown or dark brown gel is on the protective sheet. If any pad or connector gets wet, replace it with a new one. If a wet pad or connector is used, it may cause electrical shock. When using the disposable pads for long term pacing, replace them every hour. Failure to follow this warning may cause skin burn or insufficient energy discharge and pacing current to the heart.
CAUTION
When using the disposable pads for long term ECG monitoring, replace them every 24 hours. Failure to follow this instruction may cause insufficient pacing current and insufficient energy discharge to the heart. Do not attach a disposable pad over another pad. It may cause skin burn on the patient. Do not put heavy objects on the disposable pads or bend the pads. If the pads get damaged or deteriorated, it may cause skin burn on the patient.
1.13
1. GENERAL
Defibrillation, Cardioversion and AED
General WARNING
Before defibrillation and cardioversion, make sure that no one is in contact with either the patient or any metal part of any equipment or cables which supports or is connected to the patient. Failure to follow this warning causes serious electrical shock or injury. Before defibrillation and cardioversion, remove from the patient all electrodes, probes and transducers from a connector that do not have a or mark. Otherwise, the operator may receive electrical shock and the connected instrument may be damaged. Before defibrillation and cardioversion, remove everything (electrodes, patches, etc.) from the patients chest. When the defibrillator paddle directly contacts these materials, the discharged energy may cause skin burn to the patient. Before defibrillation and cardioversion, check that the cords and cables of the electrodes, probes and transducers attached to the patient are properly connected to a connector that has a or mark. Touching the metal parts of the disconnected cords and
cables may cause electrical shock or injury by discharged energy. Do not move the defibrillator when any charged energy remains in the defibrillator. If the defibrillator receives any impact, such as from falling, it discharges energy that can cause electrical shock. For this defibrillator, the CONTACT lamp on the STERNUM paddle indicates skin-paddle contact impedance. If the yellow or orange lamp lights, the defibrillator may cause serious electric burn on the patients skin and poor energy discharge to the patient. In case of an emergency, medical personnel should decide whether to execute discharge immediately, regardless of the CONTACT lamp display, or take action to make good contact before discharge. Pay careful attention to the selected energy when using the pediatric electrode plates. Applying high energy with the pediatric electrode plates can cause skin burn because the electrode plates are small. Use the ECG monitoring electrodes (disposable electrodes) to monitor the ECG waveforms. Stable ECG cannot be acquired with the PADDLE lead because it is difficult to hold the paddles stable. ECG acquired from external paddles, internal paddles or disposable pads is unstable after discharge because of high polarization voltage. Do not perform defibrillation or cardioversion in a wet place. Before defibrillation or cardioversion, move the patient and defibrillator to a dry place. Otherwise the operator may get electrical shock. Never discharge near a person or object other than the patient or test electrode plate or energy checker. It may cause electrical shock to the person or damage the object. Confirm that there is no noise on the ECG. Noise may be misrecognized as QRS and discharge might not synchronize with the patients QRS.
1.14
1. GENERAL
WARNING continued
Do not perform synchronized cardioversion with the PADDLE lead unless it is absolutely necessary. In synchronized cardioversion with the PADDLE lead, noise may be misrecognized as QRS and discharge might not synchronize with the patients QRS. Never select TEST for the ECG lead. TEST is for maintenance and the waveform displayed on the screen is not the patients ECG. If synchronized cardioversion is performed with the TEST lead, the discharge is not synchronized with the patients QRS and it may cause ventricular fibrillation. If you use the ECG signal from the monitor, before cardioversion, check that the defibrillator discharge occurs within 60 ms of the peak of the ECGs R wave with a delivery checker. If this condition is not met, the cardioversion may be ineffective or may cause ventricular fibrillation. The apex-posterior placement is not suitable for ECG monitoring or AED analysis. The anterior-posterior placement is not suitable for ECG monitoring or AED analysis. Use this placement only for pacing. Make sure to push the connector of each paddle into the paddle connector deeply until it clicks. If the connector is not properly connected, the "Connect paddle" message might not be displayed, the connector may be disconnected, and the energy might not be discharged. Pay careful attention to the selected energy when performing defibrillation on children. Performing defibrillation with high energy may cause fatal damage to the heart.
CAUTION
When performing synchronized cardioversion, confirm that the SYNC lamp is lit before every discharge. If Sync mode after CV is set to Defib on the System Setup - Configuration screen, the defibrillator automatically turns to the asynchronous defibrillation mode. Have another defibrillator ready in case of defibrillator failure. When using another defibrillator, remove the paddles of the failed defibrillator from the patient.
1.15
1. GENERAL
With External Paddles WARNING

Apply contact gel only to the electrode plates of the external paddles. Otherwise, it may cause electrical shock to the operator. Do not apply contact gel by hand. Failure to follow this warning may cause serious electrical burn, shock, or other injury. Do not hold the paddle handles if your hands are wet or have contact gel on them. This may cause electrical shock to the operator. To avoid skin burn on the patient and poor energy discharge to the heart, apply contact gel to the electrode plates of the external paddles. Do not touch the electrode plate or edge of the paddle. Failure to follow this warning may cause serious electrical burn, shock, or other injury. When charging or discharging, do not touch anything other than the handles. If any other part of the defibrillator is touched during charging or discharging, the operator receives an electrical shock. Before discharging, confirm that the paddles are firmly pressed against the chest wall. Failure to follow this warning causes skin burn or poor energy discharge to the heart. Do not discharge with the paddles in the air. This may cause electrical shock to the operator or damage the defibrillator. Do not discharge the energy if the paddles are shorted to each other by contact gel. It may cause skin burn and poor energy discharge to the heart.
CAUTION
When using the external paddles, connect it to the paddle connector until it clicks. After connecting the external paddles, use the Basic checks screen to check that the defibrillator charges and discharges energy properly. If the energy is not discharged, the connector of the external paddles is not firmly connected to the paddle connector. In this case, push the connector of the external paddles into the paddle connector deeply until it clicks. If the patients body is wet, thoroughly wipe the moisture off the skin so that the paddles do not short to each other. Do not discharge when the paddles touch each other. This may damage the defibrillator.
1.16
1. GENERAL
With Disposable Pads WARNING

Do not attach pads on the papilla, electrodes or medicine on the patients body. Failure to follow this warning causes serious skin burn. Fit the pad closely to the body surface so that current flows uniformly through the pad. Failure to follow this warning causes serious skin burn or insufficient energy discharge to the heart. During charging or discharging, do not touch the pads or connectors. Failure to follow this warning causes electrical shock to the operator. Before discharging, confirm that the pads are firmly applied to the chest wall. Failure to follow this warning causes skin burn or poor energy discharge to the heart. Do not discharge if the pads overlap each other or are shorted to each other by anything conductive such as contact gel. This may cause skin burn and poor energy discharge to the heart.
CAUTION
When connecting the pad adapter to the paddle connector, do not bend or damage the connector pin. Energy cannot be discharged to the pads. If the patients body is wet, thoroughly wipe the moisture off the skin so that the pads do not short to each other.
With Internal Paddles WARNING

Sterilize the internal paddles before use. Failure to sterilize the paddles may cause serious infection. Pay careful attention to the selected energy when using internal paddles. Applying high energy to the heart may cause cardiac muscle necrosis. Low energy is recommended. During charging and discharging, grip the internal paddles between the guard at the top of the handle and the cable. If you grip the handle between the electrode and the guard, you may get an electrical shock. Before discharging, confirm that the paddles are firmly positioned against the heart. Failure to follow this warning causes serious skin burn or poor energy discharge to the heart. Do not discharge with the paddles in the air. This may cause electrical shock to the operator or damage the defibrillator. guard
1.17
1. GENERAL
CAUTION
Do not twist the internal paddle while holding the electrode or give strong impact to the paddle. It damages the electrode. When connecting the internal paddles to the paddle connector, do not bend or damage the connector pin. Otherwise energy cannot be discharged to the paddles. Do not discharge when the paddles touch each other. This may damage the defibrillator.
AED WARNING
Do not attach pads on the papilla, electrodes or medicine on the patients body. Failure to follow this warning causes serious skin burn. Fit the pad closely to the body surface so that current flows uniformly through the pad. Failure to follow this warning causes serious skin burn or insufficient energy discharge to the heart. When you perform defibrillation in an ambulance, stop the car. During charging or discharging, do not touch the pads or connectors. Failure to follow this warning cause electrical shock to the operator. Before discharging, confirm that the pads are firmly applied to the chest wall. Failure to follow this warning causes skin burn or poor energy discharge to the heart. Do not discharge if the pads overlap each other or are shorted to each other by anything conductive such as contact gel. This may cause skin burn and poor energy discharge to the heart.
CAUTION
Before AED analysis or defibrillation, confirm that the patient is unconscious and has no respiration and no pulse. The ECG of a child or a patient with an implanted pacemaker cannot be analyzed correctly. For these patients, follow the physicians instruction. Before AED analysis, if the ECG baseline wanders, remove the causes. Otherwise, correct analysis result cannot be obtained. During AED analysis, stop life saving treatment such as CPR. Do not touch or move the patient, pad adapter and disposable pad cable. Correct analysis result cannot be obtained. When connecting the pad adapter to the paddle connector, do not bend or damage the connector pin. Energy cannot be discharged to the pads. If the patients body is wet, thoroughly wipe the moisture off the skin so that the pads do not short to each other. 1.18 Operator's Manual TEC-5500
1. GENERAL
CAUTION continued
Do not discharge when the paddles touch each other. This may damage the defibrillator. Asystole is not judged to be a shockable rhythm and the defibrillator does not automatically charge the energy.
WARNING Pacing
Do not perform pacing while using an ESU. Before using the ESU, turn the defibrillator power off and remove disposable pads from the patient. Otherwise, high frequency energy from the ESU causes abnormal current to flow into the patient and causes electrical burn, shock or other injury. It also damages the defibrillator. Always monitor the ECG waveform with the ECG connection cable and ECG electrodes. Confirm that there is no noise on the ECG. Noise may be misrecognized as QRS and correct pacing cannot be performed. Do not touch the patient, pads or connectors during pacing. It may cause electrical shock. The pacing rate must be determined by qualified medical personnel based on the heart rate of the patient in a normal state. The pacing current must only be increased by qualified medical personnel decision. Keep the current intensity as low as possible to minimize pain and discomfort to the patient. Failure to follow the following warnings causes serious skin burn. - Do not attach the pads over ECG electrode. - Do not attach pads on the papilla or medicine on the patients body. - Fit the pad closely to the body surface so that current flows uniformly through the pad. This reduces the required pacing current and pain and discomfort to the patient. The apex-posterior placement is not suitable for ECG monitoring or AED analysis. The anterior-posterior placement is not suitable for ECG monitoring or AED analysis. Use this placement only for pacing. Never select TEST for the ECG lead. TEST is for maintenance and the waveform displayed on the screen is not the patient's ECG. Do not change the sensitivity or ECG lead setting after pacing is started. If one of these settings is changed, the pacing stops for 3 seconds. Failure to follow this warning may cause serious heart attack. No QRS wave is detected: - For 240 ms after the pacing pulse is output, if the pacing rate is set to 100 ppm or more. - For 350 ms after the pacing pulse is output, if the pacing rate is set to 90 ppm or less. 1.19
1. GENERAL
CAUTION
Check that the pacing pulse is effective by observing ECG on the screen. When connecting the pad adapter to the paddle connector, do not bend or damage the connector pin. Energy cannot be discharged to the pads. If the patients body is wet, thoroughly wipe the moisture off the skin so that the pads do not short to each other.
ECG Monitoring WARNING

When using a defibrillator together with the monitor, use Ag/AgCl electrodes. Other types of electrodes, stainless steel in particular, will adversely affect the ECG waveform by slowing the baseline recovery on the monitor and result in no monitoring immediately following defibrillation. Keep pacemaker patients under close observation. The pacemaker rate may be counted during cardiac arrest and certain arrhythmias. Do not rely only on heart rate alarms and the displayed heart rate. The apex-posterior placement is not suitable for ECG monitoring or AED analysis. The anterior-posterior placement is not suitable for ECG monitoring or AED analysis. Use this placement only for pacing. With the pacing pulse rejection ON, narrow width QRS of a premature baby or infant cannot be detected correctly and the defibrillator may miscount QRS. In this case, set the pacing pulse rejection to OFF. Turn the pacing pulse rejection to OFF when monitoring a child. With the pacing pulse rejection ON, narrow width QRS of a child cannot be detected correctly and the defibrillator may miscount QRS.
CAUTION
When the Check ECG Electrodes message is displayed, ECG is not monitored properly and the ECG alarm does not function. Check the electrode, electrode leads and connection cord, and if necessary, replace with new ones. Turn the pacing pulse rejection to On when monitoring a pacemaker patient. Otherwise QRS and pacemaker spike might not be distinguished and pacing failure might not be recognized.
1.20
1. GENERAL
SpO2 Monitoring WARNING

SpO2 Measurement may be incorrect in the following cases. - When the patients carboxyhemoglobin or methemoglobin increases abnormally - When dye is injected in the blood - When using an electrosurgical unit - During CPR - When measuring at a site with venous pulse - When there is body movement - When the pulse wave is small (insufficient peripheral circulation) When not monitoring SpO2, disconnect the SpO2 connection cord from the bedside monitor. Otherwise, noise from the probe sensor may interfere and incorrect data is displayed on the screen. Check the circulation condition by observing the skin color at the measurement site and pulse waveform. Change the measurement site every 8 hours. The skin temperature may increase at the attached site by 2 or 3C (4 or 5F) and cause a burn or pressure necrosis. When using the probe on the following patients, take extreme care and change the measurement site more frequently according to symptoms and degree. - Patient with a fever - Patient with a peripheral circulation insufficiency - Neonate or low birth weight infant with delicate skin When using probes other than the TL-201T finger probe, to avoid poor circulation, do not wrap the tape too tight. Check the blood circulation condition by observing the skin color and congestion at the skin peripheral to the probe attachment site. Even for short-term monitoring, there may be burn or pressure necrosis from poor blood circulation, especially on neonates or low birth weight infants whose skin is delicate. Accurate measurement cannot be performed on a site with poor peripheral circulation. When measuring SpO2 of a patient who is in a state of shock or in CPR (cardiopulmonary resuscitation), the acquired SpO2 data may be incorrect due to the patients body movement. Do not use the probe during MRI examination because it may cause skin burn on the probe attachment area. For details, follow the MRI operators manual.
1.21
1. GENERAL
CAUTION
For long term monitoring, check the circulation condition by observing the skin color the measureing site. To avoid circullation insufficiency and skin burn, change the measurement site every specified hours. Reffer to the operators manual of the plobe you use. Do not pull or bend the probe cable, and do not put caster feet on the probe cable. Do not immerse the probe cable in chemical solutions or water. Failure to follow these instructions may cause cable discontinuity, short circuit, skin burn on the patient and incorrect measurement data. Replace any broken probe with a new one. Turn off the power of mobile phones, small wireless devices and other devices which produce strong electromagnetic interference around a patient (except for devices allowed by the hospital administrator). Radio waves from devices such as mobile phones or small wireless devices may be mistaken as pulse waves and the displayed data may be incorrect. Only use the specified probes. Otherwise SpO2 cannot be monitored properly and instrument performance may be degraded. Do not use a probe which is past the expiration date on the package. Do not use a damaged or disassembled probe. It causes incorrect measurement and may injure the patient. The disposable probe is not sterilized. Use the disposable probe only for a single patient. Never reuse the disposable probe for another patient because it causes cross infection. If the attachment site is dirty with blood or bodily fluids, clean the attachment site before attaching the probe. If there is nail polish on the attachment site, remove the polish. Otherwise, the amount of transmitted light decreases, and measured value may be incorrect or measurement cannot be performed. If the skin gets irritated or redness appears on the skin from the probe, change the attachment site or stop using the probe. Take extreme care for the patients with delicate skin. If the probe is attached to the same limb that is used for NIBP measurement or an IBP catheter, the blood circulation at the attachment site is affected and the measurement might not be correct. Attach the probe to a limb where the blood circulation is not affected. If patients nail is long, cut it or attach the probe to another finger. The probe cannot be attached properly to a finger with a long nail. Refer to the probe instruction manual for details. Neonatal skin is delicate. Remove the probe and tape carefully and slowly. When removing the probe from the attachment tape, do not pull the sensor cable because this can damage the cable.
1.22
1. GENERAL
CAUTION continued
When the probe is attached on an appropriate site with sufficient circulation and an error message about probe attachment repeatedly appears, the probe may be deteriorated. Replace it with a new one. When a message indicates a faulty probe or faulty SpO2 adapter, stop monitoring and replace the probe or SpO2 adapter with a new one. Do not use a probe which is deteriorated by aging. Accurate measurement cannot be performed. Do not use disposable probes for other patients. If the probe is dirty with blood or bodily fluids, replace it with a new one. While a patient is on medication which causes vasodilation, the pulse waveform may change and in rare cases the SpO2 value might not be displayed. Do not use creosol soap, glutaraldehyde, sodium hypochlorite, or benzalkonium chloride because they damage the probe. Do not soak the probe in cleaning solution because it is not waterproof.
CO2 Monitoring WARNING

When performing defibrillation or cardioversion during CO2 monitoring with the CO2 sensor kit, remove the sensor from the patient. When the sensor cannot be removed, do not touch the sensor cable because the discharged energy may cause serious electrical burn, shock or other injury. With the TG-901T3 CO2 sensor kit, measurements are based on the assumption of no CO2 gas in the inspiration. The CO2 concentration in the respiration is calculated by taking the CO2 concentration in the inspiration as 0 mmHg. Therefore, measuring CO2 by connecting the CO2 sensor kit to a patient under mouth-to-mouth respiration or to a Jackson Rees circuit or Mapleson D circuit where CO2 gas may be present during inspiration may result in the acquired data being lower than the actual value. With the TG-901T3 CO2 sensor kit, this monitor cannot monitor CO2 of patients weighing less than 10 kg (22 lbs). Before MRI examination, remove the CO2 sensor kit from the patient. Failure to follow this warning may cause serious electrical burn on the patient due to local heating caused by dielectric electromotive force. For details, refer to the MRI operators manual.
1.23
1. GENERAL
CAUTION
The CO2 data may be inaccurate when monitoring a patient with an extremely high respiration rate or irregular respiration. Read the measured values carefully. Measured value may be incorrect when the operating temperature changes greatly. When the CO2 sensor not working or CO2 adapter abnormality message is displayed, check the CO2 sensor kit and replace it if necessary. CO2 cannot be monitored while the message is displayed. Follow the CAUTION label on the CO2 gas cylinder. When using an anesthetic instrument with a volatile anesthetic agent, the CO2 measurement may be inaccurate.
CO2 Sensor Kit and Airway Adapter
WARNING
Do not use the airway adapter on neonates because the dead space volume of the airway adapter is about 5 mL. When using the YG-101T airway adapter on children or patients with low ventilatory amount, the CO2 may mix in the inspiration due to the airway adapters dead space volume (5 mL), resulting in inaccurate measured values or difficulty in detecting apnea. Perform ventilation taking into consideration the 5 mL dead space volume. When using the YG-121T nasal adapter on children or patients with low ventilatory amount, the CO2 may mix in the inspiration due to the nasal adapters dead space volume (1.2 mL), resulting in inaccurate measured values or difficulty in detecting apnea. Perform ventilation taking into consideration the 1.2 mL dead space volume. When you use YG-122T together with an oxygen cannula, check that the oxygen cannula is correctly attached on the patient by referring to other parameters and by observing the patient periodically. If arterial oxygen saturation does not increase, immediately stop using the oxygen cannula with the CO2 sensor kit and select another way to supply oxygen. The only oxygen cannula that can be used with YG-122T is #1103 manufactured by HUDSON RCI. Do not use any other oxygen cannula. Other oxygen cannulas cannot be attached and oxygen cannot be delivered to the patient through the nostrils. Check that the oxygen cannula tube is not bent, broken, or blocked by the nasal tube. If the ends of the oxygen cannula tube turn too far up or down, it causes insufficient oxygen supply or the CO2 value may be incorrect.
1.24
1. GENERAL
CAUTION
The airway adapter/nasal adapter is non-sterilized and disposable. Use only for a single patient and single use. Failure to follow this instruction causes cross infection. Do not sterilize the airway adapter. Safety cannot be guaranteed if the airway adapter is sterilized. Use the Nihon Kohden specified airway adapter. With the TG-901T3 CO2 sensor kit, secure the CO2 sensor to the respiration circuit so that the transparent film of the airway adapter is perpendicular to the floor. If the transparent film is parallel to the floor, water droplets may get onto the transparent film and affect the measurement accuracy. Failure to follow the instructions below degrades the anti-fogging ability of the transparent film and results in incorrect measurement. - Replace the airway adapter/nasal adapter with a new one every 24 hours. - Replace the airway adapter/nasal adapter with a new one if blood, sputum or mucus adhere to the transparent film. - Do not damage the transparent film. Do not let dust or detergent contact the transparent film. Do not touch, wipe or clean the transparent film with fingers or cleaners. Never autoclave or perform EOG gas sterilization for the TG-901T3 CO2 sensor kit. It damages the CO2 sensor kit and safety cannot be guaranteed. When using the YG-121T/YG-122T nasal adapter on a patient with bleeding disorder, poor general medical condition or malnutrition, observe the patient condition all the time. The mouth guide touches the mouth and may cause pressure sores.
Alarms WARNING
During alarm suspension (Alarm off or Alarms suspended message displayed), all current alarms except for instrument alarm group 1 are turned off. When admitting a new patient, check the alarm settings.
CAUTION
When the alarm limit is set to OFF, there will be no alarm for that limit. Be careful when you set the alarm limit to OFF. Alarms about a parameter do not occur until the measurement of the parameter starts.
1.25
1. GENERAL
Maintenance WARNING
When performing energy discharge test, keep the paddles in the paddle holders when discharging the energy. Do not discharge with the paddles in the air or when the paddles are shorted. Failure to follow this warning may cause electrical shock and damage to the defibrillator. Do not discharge with the paddles in the air. This may cause electrical shock to the operator or damage the defibrillator. If defibrillation or cardioversion is necessary during battery test, cancel the battery test and operate the defibrillator on AC power. Do not use battery power because the battery may have been discharged by the battery test.
CAUTION
Before maintenance, cleaning or disinfection, turn the defibrillator power off, disconnect the power cord from the AC socket and then remove the battery from the defibrillator. Failure to follow this instruction may result in electrical shock and defibrillator malfunction. Before battery replacement, turn off the defibrillator power and disconnect the AC power cord from the defibrillator. Otherwise, the operator may get an electrical shock. Assembly and disassembly of any component in the instrument should only be done by qualified service personnel.
Storage CAUTION
To prevent overheating, leave the defibrillator lying flat and do not cover it. Store the disposable pads in the environment described on the pads package. If stored in an environment other than specified, the pads become unusable.
1.26
1. GENERAL
Recording Sound
Surrounding sound and ECG waveforms can be recorded in an SD card in the defibrillation screen, AED screen, pacing screen and monitoring screen. Up to 2 hours of sound recording is available with the QM-064D (64 MB) Holter Card. You can save report data in the SD card (Refer to Setup Screen - Save Report). When the SD card is inserted into the defibrillator, recording automatically starts. To stop recording, 1) Turn the Energy/Mode Select Control to the SETUP position to open the Setup screen. 2) When the Can eject SD card mark appears at the upper corner of the
screen, remove the SD card by pushing it in.
CAUTION
Only remove the SD card in the Setup screen. Otherwise, the saved data may be damaged. When the SD card is removed after the power is turned off, the latest 30 seconds of data is lost.
To play back the recorded sound and ECG waveforms, refer to System Setup Use Voice File.
1.27
1. GENERAL
1.28
Section 2 Preparation
Location ............................................................................................................................... 2.1 Power .................................................................................................................................. 2.2 AC Operation ............................................................................................................ 2.2 Battery Operation ...................................................................................................... 2.2 Using AC Power .................................................................................................................. 2.3 Connecting the Power Cord ....................................................................................... 2.3 Using the Battery ................................................................................................................ 2.4 Safety Information about Battery Pack ...................................................................... 2.4 Checking the Battery Pack ............................................................................. 2.6 Storage ........................................................................................................... 2.6 Disposal .......................................................................................................... 2.6 Inserting the Battery into the Defibrillator .................................................................. 2.7 Charging the Battery Pack ........................................................................................ 2.8 Trickle Charging ......................................................................................................... 2.9 Remaining Battery Power Display ........................................................................... 2.10 Loading the Recording Paper ............................................................................................. 2.11 Basic Checks .................................................................................................................... 2.12 Displaying the Basic Checks Screen ...................................................................... 2.12 Check Procedure ..................................................................................................... 2.12 Check Before Use ............................................................................................................. 2.15 Before Turning On the Power ................................................................................... 2.15 Check Items After Turning the Power On ................................................................. 2.15
2C.1
2C.2
2. PREPARATION
Location
DANGER
Never use the defibrillator in the presence of any flammable anesthetic gas or high concentration oxygen atmosphere. Failure to follow this warning may cause explosion or fire. Never use the defibrillator in a hyperbaric oxygen chamber. Failure to follow this warning may cause explosion or fire.
WARNING
Surrounding Conditions Fluids such as Ringers saline solution and blood are excellent electrical conductors; to avoid creating potentially dangerous electrical paths, keep the defibrillator and the immediate area clean and dry at all times. Radiofrequency or Electromagnetic Field Do not use any kind of non-essential non-patient care device within a radius of 1 meter around the defibrillator. The use of non-essential non-patient care devices that emit radiofrequency or electromagnetic fields may interfere with the operation of the defibrillator by causing noise on the ECG waveform or error messages. If a non-essential non-patient care device is accidentally placed near the defibrillator, quickly remove it. Do not install this defibrillator in an MRI examination room. The defibrillator may not operate properly due to high-frequency magnetic noise from the MRI.
2.1
2. PREPARATION
Power
WARNING
Only use the provided power cord. When the provided power cord cannot be used or when equipotential grounding is doubtful (such as in poor grounding facility), operate the defibrillator on battery power. Otherwise, the patient and operator may receive electrical shock or injury.
The defibrillator can operate on either battery or AC power. You can select either AC or battery (Battery pack NKB-301V: option) according to where the defibrillator is used.
AC Operation
When the power cord is plugged into an AC outlet, the AC lamp lights. When the defibrillator power is turned on with the power cord connected to an AC outlet, the defibrillator operates on AC power. The mark is displayed on the right upper screen.
Battery Operation
When the battery is inserted and the power cord is disconnected, such as when transferring a patient, the defibrillator automatically switches to battery power. The mark is displayed on the screen. The battery can be charged only by the defibrillator. The battery is charged when the power cord is plugged into an AC outlet and AC power is supplied to the defibrillator. The battery is also charged during operation.
NOTE
For the TFT LCD screen, it is considered normal if some pixels have randomly abnormal color or do not light.
2.2
2. PREPARATION
Using AC Power
Connecting the Power Cord
WARNING
Only use the provided power cord. Using other power cords may result in electrical shock or injury to the patient and operator.
Connect the provided power cord to the AC SOURCE socket on the rear panel of the defibrillator and plug the cord into a 3-prong AC outlet. When the 3-prong power cord is connected to the 3-prong AC outlet with a ground third contact, the defibrillator is automatically grounded. When AC power is supplied to the defibrillator, the AC lamp lights.
NOTE
If the AC lamp does not light when the power cord is connected, check if the power cord is properly connected.
2.3
2. PREPARATION
Using the Battery

NOTE
The battery lifetime is one year. Before operating the defibrillator on battery, check the label on the defibrillator for the date the battery was first used. When the battery pack NKB-301V (option) is inserted in the defibrillator and the defibrillator is not connected to AC power, the defibrillator can be operated on battery. When the power cord is disconnected during AC operation, the defibrillator automatically switches to battery operation, which enables continuous operation. When the power cord is connected again, the defibrillator switches to AC operation automatically. With the fully charged new battery at 20C, the defibrillator can perform: Defibrillation at least 70 discharges at 270 J Monitoring at least 150 minutes continuous monitoring Noninvasive pacing at least 90 minutes pacing in FIXED mode at 180 ppm and 200 mA With the fully charged new battery at 0C, the defibrillator can perform: Defibrillation at least 50 discharges at 270 J
Safety Information about Battery Pack
DANGER
Keep the battery pack away from fire. Do not heat the battery pack. If the battery pack is heated, the substance inside the battery squirts out and the battery pack explodes. Never connect the + and terminals on the battery pack with a wire. Never store the battery pack with metals such as necklace or hair pins. The battery pack may short-circuit, causing the substance inside the battery to leak or explode. Never disassemble or modify the battery pack. Never damage or directly solder the sheath tube. The battery pack may short-circuit, the substance inside the battery may squirt out and the battery pack may explode. Do not subject the battery pack to a strong shock. The battery may leak and explode. Do not use a battery which is damaged, such as from falling. The battery has a gas discharge valve and if this valve is damaged, the gas cannot be discharged, causing the battery to explode. If the battery pack is damaged and the substance inside the battery (nickel-metal hydride) contacts the eyes or skin, wash immediately and thoroughly with water and see a physician. Never rub your eyes, because you may lose your eyesight. The battery pack has + and polarity. Make sure that the battery is
2.4
2. PREPARATION Danger - continued installed in the correct direction. Do not connect the battery with force if it cannot be connected easily. If the battery is connected with the wrong polarity, the substance inside the battery may leak and explode. Do not charge the battery pack with an instrument other than this defibrillator. With another instrument, abnormal current flows and the battery may leak and explode. Do not connect the battery pack to an AC outlet or lighter socket in a car. The battery may leak and explode.
WARNING
Test the battery once a month. When you start using a new battery pack, write the date of first use on the labels on the battery pack and defibrillator. Replace the battery pack every year. If defibrillation or cardioversion is necessary during the battery test, cancel the battery test and operate the defibrillator on AC power. Do not use battery power because the battery may have been discharged by the battery test. Do not immerse the battery pack in water. The battery heats up and rusts and the substance inside the battery leaks. Never use a battery pack which is damaged, discolored or has leakage. The battery may explode if used. Do not leave the battery unused for more than about one year. The battery may leak.
CAUTION
When inserting or removing the battery, disconnect the power cord from the defibrillator. Otherwise, the operator may receive electrical shock. To keep the battery fully charged, always keep the power cord connected to the AC outlet even when the defibrillator is not used. Otherwise, the battery may discharge and become unusable. Do not expose the battery pack to direct sunlight or leave in a high temperature place. The lifetime of the battery pack may be shortened, the performance of the battery pack may be degraded and the battery may leak. The battery pack must be inserted by a qualified service personnel. Keep the battery pack away from children.
2.5
2. PREPARATION
NOTE
Fully charge the new battery pack before using on the defibrillator. Do not use a battery pack which is past the expiration date written on the label. If the battery pack becomes unusable or the available discharge time has decreased, do not leave the battery pack in the defibrillator. The substance inside the battery may leak, causing instrument corrosion and fire. Immediately replace the battery with a new one. Do not leave a battery pack inside the defibrillator without the power cord connected between the defibrillator and AC outlet. The battery pack may be over-discharged and can no longer be used. When not using the defibrillator for more than six months, remove the battery pack from the defibrillator and store the battery at temperatures between 20C (4F) and +35C (95F) and low humidity. Before disposing of the defibrillator, make sure that the battery pack is removed from the defibrillator. Before disposing of the battery, check with your local solid waste officials for details in your area for recycling options or proper disposal. The battery is recyclable. At the end of its useful life, under various state and local laws, it may be illegal to dispose of this battery into the municipal waste stream.
Checking the Battery Pack In order to ensure emergency use of the defibrillator on battery power, perform the battery test once a month. To prevent battery trouble, check the battery appearance every 6 months. If there is any damage (crack, deformation, cable discontinuity and so on) on the battery or the battery leaks, replace the battery with a new one. If the battery is dirty with dust, remove it.
Storage
WARNING
Do not leave the battery unused for more than about one year. The battery may leak.
When not using the defibrillator for more than one month, to prevent leaking or rusting of the battery, remove the battery pack from the defibrillator and store the battery at surrounding temperatures between -20C (4F) and +35C (95F) and low humidity. When a battery is not used for over one month, fully charge it before use. Even if the battery was fully charged before storage, the battery self-discharges and operation time decreases. To ensure full performance of the defibrillator, replace the battery every one year. When a battery is stored for a long time, the battery tends to deactivate and the original battery capacity cannot be used to 100%. The capacity may recover by repeating full discharging and full charging several times. 2.6 Operator's Manual TEC-5500
2. PREPARATION Disposal The battery is NiMH. Before disposing of the battery, check with your local solid waste officials for details in your area for recycling options or proper disposal. The battery is recyclable. At the end of its useful life, under various state and local laws, it may be illegal to dispose of this battery into the municipal waste stream.
Inserting the Battery into the Defibrillator
Before inserting the battery, check the battery appearance and write the date of first use on the label on the battery. After inserting the battery, charge the battery.
NOTE
Use only the battery pack NKB-301V. Perform the battery test once a month. Check the battery appearance every 6 months. Replace the battery every one year. The battery pack must be inserted by a qualified service personnel. 1. Before inserting the battery into the defibrillator, write the date of the first use on the label on the battery. 2. Confirm that the Energy/Mode Select control is set to OFF. Disconnect the power cord from the defibrillator.
CAUTION
When inserting or removing the battery, disconnect the power cord from the defibrillator. Otherwise, the operator may receive electrical shock.
3. Turn the knob on the battery holder cover counterclockwise and remove the battery pack holder cover.
4. Insert the battery into the battery pack holder. 5. Securely connect the battery connector to the connector inside the battery pack holder until it clicks and locks. 6. Close the battery pack holder cover. Be careful not to pinch the cable. Secure the battery pack holder cover by turning the knob clockwise. * defibrillator standard accessory ** battery standard accessory 7. On the battery check label*, write the date of battery first use and the date the battery is checked. On the start date label**, write down the date of battery first use. Attach each label on the defibrillator so that you can see them easily, for example, on the upper part of the right side panel.
2.7
2. PREPARATION
9. Reset the date of first use of the battery. 1) Display the System Setup - Battery Test screen. 2) Press the Reset key to reset the date of first use of the battery. The Time to replace battery message appears one year after the Reset key is pressed.
NOTE
You must do this step when the battery is replaced. Otherwise, the defibrillator does not display the Time to replace battery message to prompt you to replace the battery.
Charging the Battery Pack
The battery can be charged only by the defibrillator. When 0 appears on the screen, immediately charge the battery. When 0 is displayed on the screen, the defibrillator cannot charge the defibrillation or cardioversion energy. The new battery is not charged.
NOTE
When you use a new battery, charge the battery at least 3 hours until the battery charge complete lamp lights. Always charge the battery pack at surrounding temperatures between 0C (32F) and 40C (104F). Charging may stop when the battery is charged at surrounding temperatures higher than 45C (113F). In this case, move the defibrillator to a cooler place. When the battery temperature decreases, the battery charging resumes. Charge the battery pack only by the defibrillator. If the battery pack is charged with another instrument, abnormal current flows, the substance inside the battery leaks and the battery explodes. Also it causes defibrillator malfunction and instrument trouble. When charging the battery, confirm that the AC lamp is lit and either the battery charging lamp or battery charge complete lamp is lit. Charge the battery pack immediately after it is used. If it is left uncharged, the battery will become unusable because of overdischarge.
Charging procedure 1. Set the Energy/Mode Select control to the OFF position. 2. Connect the power cord to the defibrillator. The battery charging lamp on the front panel lights and the charging (rapid charging) starts.
NOTE
Do not disconnect the power cord until charging finishes. 3. When rapid charging finishes, the battery charge complete lamp lights.
2.8
2. PREPARATION
NOTE
When the battery charging lamp continues to be lit over 5 hours (the battery charge complete lamp does not light), the battery is abnormal. Perform battery test and if the battery proved to be abnormal, replace it with a new one. Blinking battery charging lamp indicates that the temperature inside the defibrillator is rising. In this case, immediately quit charging. Move the defibrillator to a cool place and start charging again. Charging starts after the temperature inside the defibrillator decreases.
Trickle Charging
After battery charge complete lamp lights, keep the power cord connected to the AC outlet regardless of whether the defibrillator is used or not. The trickle charge starts in order to keep the battery fully charged.
CAUTION
To keep the battery fully charged, always keep the power cord connected to the AC outlet even when the defibrillator is not used. Otherwise, the battery may discharge and become unusable.
NOTE
When the defibrillator operates on a fully charged battery and , 1 3 or 0 appears soon, the battery is deteriorated. Check the capacity by the battery test. If a Battery WEAK or Replace battery message appears, replace the battery with a new one. Perform the battery test once a month.
Trickle charge Trickle charge is a method to charge with small current to compensate for the loss by self discharge. This prevents the decrease of battery capacity caused by self discharge.
2.9
2. PREPARATION
Remaining Battery Power Display

Mark
When the defibrillator operates on battery, the remaining battery power is displayed on the top right of the screen. When a message appears, an alarm sounds.
Message --Remaining Battery Power Remain enough Remain about 2/3 Remain 1/3 or less Battery is discharged. Replace the battery with a charged battery or switch to AC operation. Cannot operate on battery. The power turns off soon. Replace the battery with a charged battery or switch to AC operation. Available discharges (20C, 270 J charge) 40 discharges or more About 20 to 40 discharges About 4 to 20 discharges 3 discharges or less
--Battery discharged* Battery discharged
1 3
Charge battery
0
Not available
* displayed for 5 or 6 seconds.
NOTE
The values in the table are under the condition that the battery is handled as specified in this manual. The value is affected by the battery usage and storage conditions. While the recorder is running, the operation time is shorter than indicated in the table. The defibrillator cannot charge energy when the battery mark is blinking. Immediately connect the defibrillator to AC power or replace the battery with a fully charged one. When using a battery that is not fully charged, the remaining battery power display may be incorrect.
2.10
2. PREPARATION
Loading the Recording Paper

NOTE
Only use the FQS50-2-100 Z-fold type recording paper. 1. Pull the door release lever of the recorder up to open the door. For safety, the door stops half-open. Pull the door completely down with your hand.
2.
Set the recording paper inside the recorder with the printed side up.
To load z-fold recording paper, first pull the slide plate toward you until it clicks and load the paper. To load roll type recording paper, first push the slide plate back to the inside until it clicks and load the recording paper in the hollow.
3. Draw out the paper toward you and close the door until it clicks.
4. Press the Record key on the front panel to feed the recording paper.
2.11
2. PREPARATION
Basic Checks
With the basic checks, the following five functions are checked. Perform the basic checks everyday. Discharge check Battery check Recorder check Alarm check Voice check Pacing check (TEC-5531 series only) Defibrillation waveform check
Displaying the Basic Checks Screen
Turn the Energy/Mode Select control to the BASIC CHECK position. The Basic checks screen appears.
VF/VT : In the Basic checks screen, the VF/ VT detection function is automatically turned off.
Check Procedure
WARNING
When performing energy discharge test, keep the paddles in the paddle holders when discharging the energy. Do not discharge with the paddles in the air or when the paddles are shorted. Failure to follow this warning may cause electrical shock and damage to the defibrillator.
NOTE
When the Basic checks screen is displayed, the waveform is automatically switched to TEST and the patient ECG waveform is not monitored. To monitor the patient, finish the basic checks or turn the Energy/Mode Select control to the MONITOR position. Do not continuously perform the Basic checks more than the specified number of charge/discharge cycles. Refer to Specification Defibrillator - Maximum continuous charge/discharge cycles at 270 J in Section 11.
2.12
2. PREPARATION When you start basic checks, all items are checked automatically. Follow the instruction on the screen and press the corresponding key. Results are displayed in the right column for each item as (pass) or
(fail). When all items are finished, the results are recorded on the recording paper. For failed items, the defibrillator may be faulty. Contact your Nihon Kohden distributor or representative. 1. Press the OK key to start basic checks. Discharge check starts. Press the Cancel key to cancel the item which is currently checked and start checking the next item. 1) Discharge check Energy charging starts. The CHARGE lamp blinks, there is a beeping sound and a CHARGING **J message is displayed on the screen. When charging completes, the CHARGE lamp lights and there is a continuous buzzing sound. Confirm that 270 J and CHARGED messages appear on the screen. Then, the Press discharge buttons until discharge message appears. With the paddles in the paddle holder, simultaneously press both DISCHARGE buttons on the external paddles. Hold the buttons pressed until energy is discharged to the paddle holders. The energy is discharged in synchronization with the TEST waveform. Check that the displayed energy value becomes 0J and the screen. Recording example of the discharge check is displayed on
2) Battery check Check that is displayed on the screen. 3) Recorder check A Did the recorder print? message is displayed on the screen. Press the Yes key when paper was output, and the No key when paper was not output. 4) Alarm check A Did the alarm sound? message is displayed. Press the Yes key when the alarm sounded, and the No key when the alarm did not sound.
2.13
2. PREPARATION 5) Voice check A Was the voice heard? message is displayed and there is a voice Use disposable paddle. Press the Yes key when the voice was heard, and the No key when the voice was not heard. 6) Pacing check
NOTE
Check that the external paddles are properly placed on the paddle holders and that the external paddle connector is firmly connected to the paddle connector. Otherwise, the pacing check does not start. During the pacing check, if an external paddle is removed from the paddle holder or the external paddle connector is disconnected, the pacing check stops. When the external paddle is redurned to the paddle holder or the external paddle connector is reconnected, the green paddle contact lamp lights and 5 seconds later the pacing check resumes at 50 mA pacing current. During this check, QRS synchronization point is not displayed. This check is only abilable for the TEC-5531 Series Defibrillator. The pacing monitor in the defibrillator checks the eight pacing pulses output from the external paddles. The check is performed by changing the pacing current as follow. Pacing mode: fixed Pacing rate: 180 ppm (fixed) Pacing pulse: 50 100 150 200 mA The detected pacing pulse is displayed with an * mark for each current. 2. When all checks finish, a Basic checks complete message appears on the screen and the check result is recorded on the recording paper. If a Use another instrument message appears, stop using the defibrillator and contact your Nihon Kohden distributor or representative. If any item fails, contact your Nihon Kohden distributor or representative. 3. Defibrillation waveform check The defibrillation waveform that is output in the Discharge check can be displayed by pressing the Wave shape key. To return to the Basic check menu, press the return key.
NOTE
On the Basic checks screen, if the Energy/Mode Select control is set to positions other than BASIC CHECK, the Basic checks screen immediately closes and switches to the screen of the selected mode. Make sure that the time printed on the recording paper is correct. The date and time on the recording paper are important information of the medical record.
2.14
2. PREPARATION
Check Before Use

Before use, do the following checks to confirm that the defibrillator is in normal condition and can be used safely. If there is any abnormality, take appropriate remedial actions referring to the Maintenance section in this manual. If the defibrillator seems to be faulty, attach a Not available or Repair request label on the defibrillator and contact your Nihon Kohden distributor or representative.
Before Turning On the Power
Before turning on the power, check the following items. Accessories Paddles, pads and cables prepared Sufficient recording paper Sterilized internal paddle electrode prepared, if necessary Sufficient disposable pads, if necessary Sufficient contact gel (GELAID) Sufficient number of disposable electrodes Connection and Setting Specified 3-prong power cord and ground lead are properly connected Recording paper is loaded Battery is fully charged (battery charge complete lamp is lit) Overview Defibrillator is not dirty, rusted, damaged or in contact with liquid Operation panel is not torn or broken All keys, buttons and control are undamaged and function properly Power cord, cables and pins of the paddle connector are not frayed or damaged
Check Items After Turning the Power On
Power on The AC lamp lights when the power cord is connected to the defibrillator. There is no fire, smoke or smell. There is no electrical shock when touching the defibrillator. Defibrillator is not abnormally hot. Defibrillator does not affect surrounding equipment. Basic operation The screen display is correct. (brightness, distortion) Lamp indication is correct. All keys, buttons and control operate properly. All settings are correct. The battery is fully charged. No abnormality is found in the basic checks. (No abnormality in charging/ discharging, battery, recorder, alarm sound, voice and pacing check) Time printed on the recording paper is correct.
2.15
2. PREPARATION Alarm functions properly. The paper is fed correctly. (no wandering or jam) Recorded waveforms and letters are clear. There is no error message or abnormal operation.
Alarm Alarm settings are correct.
NOTE
Make sure that the date and time printed on the recording paper is correct. The date and time on the recording paper are important parts of the medical record.
2.16
Section 3 System Setup Screen and Setup Screen

System Setup Screen ......................................................................................................... 3.2 How to Change the Items on the System Setup Screen ........................................... 3.2 Configuration ............................................................................................................. 3.3 Setting List...................................................................................................... 3.4 Setting Description .......................................................................................... 3.6 Battery Test ............................................................................................................. 3.12 HV Capacitor Test ................................................................................................... 3.12 Recorder Check ...................................................................................................... 3.12 System Information ................................................................................................. 3.12 Report History ......................................................................................................... 3.12 Use Voice File ......................................................................................................... 3.13 Setup Screen .................................................................................................................... 3.14 Setup Item List ....................................................................................................... 3.14 How to Change the Settings on the Setup Screen .................................................. 3.15 Paddle Setup ........................................................................................................... 3.16 ECG Setup .............................................................................................................. 3.16 SpO2 Setup ............................................................................................................. 3.16 CO2 Setup ............................................................................................................... 3.16 Report Setup ........................................................................................................... 3.16 Recorder Setup ....................................................................................................... 3.16 Date/Screen ............................................................................................................ 3.16 Date and Time ............................................................................................... 3.16 2nd Wave ...................................................................................................... 3.17 QRS Setup .............................................................................................................. 3.17 Alarm Setup ............................................................................................................ 3.17 Save Report ............................................................................................................ 3.18
3C.1
3C.2
3. System Setup Screen and Setup Screen You can change the hardware and software settings on the Setup screen and System Setup screen. The System Setup screen also provides the hardware check functions. When a Setup or System Setup screen is opened, the ECG lead key, ECG sensitivity key, Silence alarms key and Multi-function key become the function keys for the functions on the screen which are displayed above each key.
NOTE
Defibrillation, cardioversion and pacing are not available while the Setup screen or System Setup screen is displayed. Setting items on the System Setup screen and checking the hardware must be performed by the administrator of this defibrillator at your hospital or by a person with medical and technical knowledge.
3.1
3. System Setup Screen and Setup Screen
System Setup Screen

How to Change the Items on the System Setup Screen
Turn the Energy/Mode Select control to the SETUP position while pressing and holding the Silence alarms key. Hold the Silence alarms key until the System Setup Menu screen appears.
About the System Setup - Menu screen 1. Configuration This changes system settings. 2. Battery Test This checks the built-in battery performance to confirm safe battery operation. 3. HV Capacitor Test This checks the performance of the HV (high voltage) capacitor to charge the energy for defibrillation and cardioversion. 4. Recorder Test This checks the built-in-recorder with preset waveforms and alphanumeric characters. 6. System Information This shows system information. 7. Report History This records information for maintenance. 9. Use voce File Play backs sound saved in an SD card. To select the item, press the Item key and press the OK key. The selected screen opens. To exit the System Setup screen, turn he Energy/Mode Select control to any position other than SETUP.
NOTE
The changed settings are immediately applied when they are selected. If you want to return a setting to its previous value, set the setting again. 3.2 Operator's Manual TEC-5500
Configuration
This changes system settings. 1. On the System Setup Menu screen, select 1. Configuration with the Item key. 2. Press the OK key. The System Setup - Configuration screen appears. You can print the hard copy of the currently displayed System Setup screen by pressing the Record key.
2. Press the Item or Item key to select a parameter. The selected parameter is highlighted. If the desired parameter is not on the current screen, scroll the screen with the Item or Item key. 3. Press the Select key to select the setting. Every time the Select key is pressed, the setting is changed. To return to the System Setup - Menu screen, press the Menu key.
3.3
3. System Setup Screen and Setup Screen Setting List The factory default settings are underlined.
No.
Parameters
Description
Settings
Select the 1st, 2nd and 3rd energy in AED 1 AED Energy mode. The number of charges for one sequence in AED mode is set in 5. Discharge/AED sequence. After the third discharge, repeat the entire 2 Energy after 3rd discharge energy cycle (1st 2nd 3rd 1st) or repeat the 3rd energy (1st 2nd 3rd 3rd).
2, 3, 5, 7, 10, 15, 20, 30, 50, 70, 100, 150, 200, 270 J) (Default setting: 150 for 1st, 200 for 2nd, 270 for 3rd)
Repeat cycle, 3rd energy
ON: Select whether or not to start AED analysis 3 AED button First Analysis by pressing the CHARGE/AED button when AED mode is selected. After each discharge, select whether manually or automatically start AED analysis. Number of discharges for one sequence in AED mode Wait time until starting AED analysis in background after one sequence. Duration of CPR timing sound in AED mode Pause time to temporarily pause background AED analysis in AED mode. Select the confirmation method to enter manual defibrillation mode. Password to enter manual defibrillation mode Time after charging is complete until the defibrillator internally discharges After synchronized cardioversion, continue 12 Sync mode after CV synchronized cardioversion mode (Sync) or return to defibrillation mode (Defib).
Press the CHARGE/AED button to start AED analysis.
OFF: When AED mode is selected AED analysis is automatically started.
AED button 2nd or later Analysis Discharge/AED sequence CPR time (s) CPR timing sound Pause Time Manual defib confirmation Password Charge holding time (s)
Each shock, Each Seq., OFF
5 6 7 8 9 10 11
1, 2, 3, 4 30, 60, 90, 120, 150, 180, 210 (s) , OFF 60, 70, 80, 90, 100, 110, 120 (s), OFF 30, 60, 120, 180 (s) None, Confirm, Password Four digit password from 1, 2, 3, 4 (Default setting: 1111) 30, 40, 50, 60 (s)
Sync, Defib 1: After discharge, or after no
13
Check Pulse Pattern
Select the timing of checking pulse.
shockable rhythm, or after CPR 2: Only after CPR 3: No checking pulse Valid characters: 0 to 9, a to z, A to Z, . , - , :, space, Default setting: serial number PADDLE, II 3 LEAD, 5 LEAD 25, 50 (mm/s) 6.25, 12.5 (mm/s)
Five digit ID number for this defibrillator. 14 15 16 17 18 ID Power on lead ECG leads ECG, SpO2 sweep speed CO2 sweep speed (mm/s) The ID number is printed on the recording paper. Select lead the when the power is on. Select available ECG leads. ECG and SpO2 waveform sweep speed on the screen CO2 waveform sweep speed on the screen
3.4
No.
Parameters
Description
Settings
19 20 21 22 23 24 25 26 27 28 29 30
Alarm Setting Alarm sound Alarm Volume Charge Sound Volume Voice Prompt Volume Delayed recording Alarm recording Record on charging after discharge Record CAL wave Paper speed (mm/s) Periodic recording interval (min) Printing character size
Select the alarm settings when the power is on. Vital alarm sound type Alarm sound volume. Charge sound volume. Voice prompt volume. Select whether or not to perform delayed recording. Select whether or not to perform automatic recording on vital alarm occurrence Select whether or not to perform automatic recording when energy charging starts Select whether or not to record the CAL waveform in manual recording. Paper speed of the recorder Select the interval when periodic recording is set to FREE. Character size printed on the recording paper
Latest, Default Cont tone, Beeping 1, 2, 3, 4 1, 2, 3, 4 1, 2, 3, 4, OFF ON, OFF ON, OFF ON (6 s), ON (12 s), OFF ON, OFF 25, 50 (mm/s) 1 to 9, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 (min) Large, Small YYYY/MM/DD
31
Data format
Date format
MMM/DD/YYYY YYYY/MMM/DD DD/MM/YYYY
Select whether or not to display the 32 Medication medication function keys when the Event key is pressed. AC line frequency. This setting is 33 AC line frequency important to reduce artifact in SpO2 measurement. 34 35 36 37 38 39 TEST lead Pressure units Pacing Current Steps Pacing Power on Settings --Load Settings Select whether or not TEST lead can be selected. Units used in CO2 measurement Select the step to increase or decrease the pacing current. Select the pacing current and pacing rate settings when the power is on. --Select ON to load the system setup settings and setup settings from the SD card. Select ON to save the system setup settings and setup settings in the SD card. Select ON to format the SD card. Initializes all System Setup settings. ON, OFF mmHg, kPa 1, 2, 5, 10 (mA) Default, Latest --OK, OFF 50, 60 (Hz) ON, OFF
40 41 42
Save Settings Format Card System initialize
OK, OFF OK, OFF OK, OFF
3.5
3. System Setup Screen and Setup Screen Setting Description The factory default settings are underlined. 1. AED Energy Select the first, second and third energy in AED mode. The selected energy is automatically charged when a shockable waveform is detected. The number of discharges for one sequence in AED mode is set in 5. Discharge/AED sequence . Selection list: 2, 3, 5, 7, 10, 15, 20, 30, 50, 70, 100, 150, 200, 270 J 2. Energy after 3rd discharge Select the energy after the third discharge in AED mode. Repeat cycle: The first energy is selected. 3rd energy: The third energy is selected Repeat cycle: After third discharge, the energies of the first, second and third discharge are repeated. (Example) 1st: 150 J 2nd: 200 J 3rd: 270 J 4th 150 J (same as the 1st energy) 5th: 200 J (same as the 2nd energy) 6th: 270 J (same as the 3rd energy) 7th: 150 J (same as the 1st energy) : 3rd energy: The energy after the 3rd discharge is the same as the energy of the 3rd discharge. (Example) 1st: 150 J 2nd: 200 J 3rd: 270 J 4th: 270 J (same as the 3rd energy) 5th: 270 J (same as the 3rd energy) 6th: 270 J (same as the 3rd energy) 7th: 270 J (same as the 3rd energy) : 3. AED button First Analysis When AED mode is selected, select whether or not to start AED analysis (shockable waveform detection) by pressing the CHARGE/AED button. ON: Press the CHARGE/AED button to start AED analysis in AED mode. OFF: When AED mode is selected, AED analysis is automatically started.
3.6
3. System Setup Screen and Setup Screen 4. AED button 2nd or later Analysis After each discharge or sequence, select whether to manually or automatically start AED analysis. Each Shock: Press the CHARGE/AED button to start AED analysis after each discharge. Each Seq: OFF: Press the CHARGE/AED button to start AED analysis after each sequence. AED analysis is automatically started after each discharge or after each sequence.
5. Discharge/AED sequence Select the number of discharges for one sequence in AED mode. Selection list: 1, 2, 3, 4 6. CPR time (s) Select the wait time until starting AED analysis in background after one sequence. Selection list: 30, 60, 90, 120, 150, 180, 210 seconds, OFF 7. CPR timing sound Select the duration of the CPR timing sound in AED mode. Selection list: 60, 70, 80, 90, 100, 110, 120 seconds, OFF 8. Pause time Select the pause time to temporarily pause background AED analysis in AED mode. In AED mode, the Multi-function key changes to the Pause function key. Selection list: 30, 60, 120, 180 seconds and OFF 9. Manual defib confirmation Select the confirmation method to enter manual defibrillation mode from AED mode. None: When the Energy/Mode Select control is set to an energy value position, the defibrillator enters manual defibrillation mode. This is useful when the operators are physicians. Confirm: When the Energy/Mode Select control is set to an energy value position, the confirmation key appears. Press the OK key to enter manual defibrillation mode. This is useful when the operators are not physicians. Password: When the Energy/Mode Select control is set to an energy value position, the password key appears. Enter the four digit password to enter manual defibrillation mode. This is useful when you want to specify the operator. 10. Password Set the password to enter manual defibrillation mode from AED mode. This password is necessary when Manual defib confirmation is set to Password. Make the four digit password by from the 1, 2, 3 and 4 keys (Default setting: 1111). Operator's Manual TEC-5500 3.7
3. System Setup Screen and Setup Screen 11. Charge holding time (s) Select the time after charging is complete until the defibrillator discharges the charged energy internally. Selection list: 30, 40, 50, 60, seconds 12. Sync mode after CV After synchronized cardioversion, selects whether synchronized cardioversion mode is continued or it is swithed to defibrillation mode. Defib: After synchronized cardioversion, it automatically switches to defibrillation mode. After one external discharge with the SYNC button pressed, the defibrillator switches to asynchronous defibrillation mode. Sync: After synchronized cardioversion, the defibrillator remains in synchronized cardioversion mode. Synchronized cardioversion mode lasts until the SYNC button is pressed again. 13. Check Pulse Pattern Select the timing of checking pulse. 1: After discharge, or after no shockable rhythm, or after CPR 2: Only after CPR 3: No checking pulse 14. ID Set a five digit ID number. The ID number is printed on the recording paper. To select the digit you want to change, press the Item or Item key. To select a number and letter, press the Select key. It changes in the order: 0, 1, 9, a, b, z, A, B, Z, -, :, ., (space) . When the defibrillator is shipped from the factory, the ID number is set to the serial number. 15. Power on lead Select the lead when the defibrillator power is turned on. PADDLE: Displays ECG waveform from external paddles, internal paddles or disposable pads. II: Displays ECG waveform in II lead from ECG disposable electrodes. 16. ECG leads Select available ECG leads. 3 LEAD: I, II and III leads are available 5 LEAD: I, II, III, aVR, aVL, aVF, V leads are available. * The optional QI-552V DSI interface unit or QI-553V DSI/AUXOUT interface unit is necessary for SpO2 or CO2 measurement. 17. ECG, SpO2 sweep speed (mm/s)* Select the ECG, SpO2 waveform sweep speed on the screen. Selection list: 25, 50 mm/s (Normally select 25 mm/s.) 18. CO2 sweep speed (mm/s)* Select the CO2 waveform sweep speed on the screen. Selection list: 6.25, 12.5 mm/s (Normally select 12.5 mm/s.)
3.8
3. System Setup Screen and Setup Screen 19. Alarm Setting Select the alarm settings when the power is turned on. Latest: Use the alarm settings from the previous use. This is useful where you want usually use settings other than the default settings, for example, in a pediatric department. Default: Alarm settings are set to the default settings. This is useful when you the one defibrillator for many kinds of patients. 20. Alarm sound Select the vital alarm sound type. Cont tone: The alarm sounds continuously. Beeping: The alarm sounds for 3 seconds every 30 seconds. 21. Alarm Volume Select the alarm sound volume. Selection list: 1, 2, 3, 4 22. Charge Sound Volume Select the charge sound volume. Selection list: 1, 2, 3, 4 23. Voice Prompt Volume Select the voice prompt volume. Selection list: 1, 2, 3, 4, OFF 24. Delayed recording Select whether or not to perform delayed recording. ON: Records the waveform 4 seconds before the Record key is pressed. OFF: Records the same waveform as that displayed on the screen. 25. Alarm recording Selects whether or not to perform automatic recording on vital upper/lower alarm occurrence. Selection list: ON, OFF 26. Record on charging after discharge Selects whether or not to perform automatic recording when energy charging starts. ON (6 s), ON (12 s): Automatic recording starts when energy charging starts, and the recording stops 6 or 12 seconds after external discharge. If the charge holding time ends after the energy is fully charged, recording stops automatically. OFF: Automatic recording does not start when energy charging starts. 27. Record CAL wave Selects whether or not to record a CAL waveform at the beginning of recording. Selection list: ON, OFF Operator's Manual TEC-5500 3.9
3. System Setup Screen and Setup Screen 28. Paper speed (mm/s) Select the paper speed of the recorder. 25: 50: Paper feeds 25 mm per second. Usually this setting is selected. Paper feeds 50 mm per second. Suitable for a patient with rapid heart rate.
29. Periodic recording interval (min) Select the interval of periodic recording. This setting is available when Periodic Rec on the Recorder Setup screen is set to FREE. Selection list: 1 to 9, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes 30. Printing character size Select the character size printed on the recording paper. Large: Prints large size characters. Small: Prints small size characters. 31. Data format Select the date format printed on the recording paper. YYYY/MM/DD: year (four digits) / month (two digits) / day (two digits) MMM/DD/YYYY: month (three digits) / day (two digits) / year (four digits) YYYY/MMM/DD: year (four digits) / month (three digits) / day (two digits) DD/MM/YYYY: day (two digits) / month (two digits) / year (four digits) 32. Medication Select whether or not to display the medication function keys (Adrenalin, Atropine, Lidocaine, Other) when the Event key is pressed. Selection list: ON, OFF 33. AC line frequency Selects the AC line frequency. This setting is important to reduce artifact in SpO2 measurement. Settings: 50, 60 Hz 34. TEST lead Select whether or not TEST lead can be selected. ON: TEST lead can be selected. (displayed) OFF: TEST lead cannot be selected. (not displayed) * The optional QI-552V DSI interface unit or QI-553V DSI/AUX out interface is necessary for CO2 measurement. 35. Pressure units* Select units used in CO2 measurement. Selection list: mmHg, kPa 36. Pacing Current Steps (TEC-5531 series only) Select the step to increase or decrease the pacing current with the PACING OUTPUT Up/Down key. Selection list: 1, 2, 5, 10 mA
3.10
3. System Setup Screen and Setup Screen 37. Pacing Power on Settings (TEC-5531 series only) Select the pacing settings (pacing current and pacing rate) when the power is turned on. Default: Pacing settings are set to the default settings. Latest: Pacing settings are set to the settings of the previous use. 39. Load Settings Select ON to load the system setup settings and setup settings from the SD card. Selection list: OK, OFF 40. Save Settings Select OK to save the system setup settings and setup settings in the SD card. Selection list: OK, OFF 41. Format Card Select OK to format the SD card. Selection list: OK, OFF 42. System initialize Select OK to initialize the system setup settings and setup settings. Selection list: OK, OFF If OK is selected, a further message appears as below. OK: Initialization starts. Cancel: Cancels initialization.
3.11
Battery Test
Refer to Section 10 Periodical Checks - Battery Test.
HV Capacitor Test
Refer to Section 10 Periodical Checks - HV Capacitor Test.
Recorder Check
Refer to Section 10 Periodical Checks - Recorder Test.
System Information
This item displays the system information. 1. On the System Setup-Menu screen, select System Information by pressing the Item key and press the OK key. The system information is displayed on the screen. 2. Press the Menu key to return to the System Setup - Menu screen.
Report History
Information for maintenance is printed. 1. On the System Setup - Menu screen, select Report History with the Item key and press the OK. The Report History screen opens. 2. To print an error history (error code) 1) Select Instrument report with the Item key 2) Press the Record key. The history of the error (error code), battery test and HV capacitor test is recorded together. For the error code, refer to the service manual. To print the operation history since the selected date 1) Select Year with the Item key and select a year with the or key. 2) Select the Month, Day, Hour and Minute in the same way. 3) Press the Record key. To cancel printing, press the Record key. To return to the System Setup - Menu screen, press the Menu key.
3.12
Use Voice File
In the Use Voice File screen, you can play back the recorded sound and ECG waveforms saved in the SD card. 1. On the System Setup-Menu screen, select Use Voice File by pressing the Item and press the OK key. The Use Voice File screen is displayed.
2. Select the file with the or key and press the Playback key. The ECG waveforms in the selected file are played back.
To view the ECG waveforms beyond the border of the screen, press the or key. To play back the sound, press the Playback key.
To rewind the waveforms and sound, press the key To stop playing back, press the Stop key. 3. Press the Return key to return to the file selection list. 4. Press the Menu key to return to the System Setup - Menu screen. Operator's Manual TEC-5500 3.13
Setup Screen
Set the settings to fit your usage purpose.
NOTE
The changed settings are immediately applied to operation when they are selected. If you want to return a setting to its previous value, set the setting again. When the screen changes to any setup screen during recording, recording automatically stops. Record again after exiting the setup screen.
Setup Item List

Item Description
Sync by paddle lead Paddle setup Heart rate alarm with paddle lead AC hum filter Time Constant Pacing Pulse Reject HR alarm Sens SpO2 Sound SpO2 setup PR alarm SpO2 alarm Scale etCO2 alarm RR alarm APNEA alarm Report Trend Time List Interval Delete Report?
ECG setup
CO2 setup
Report setup
Recorder setup Date/Screen QRS Setup
PeriodicRec RecWave Year, Month, Day, Hour, Minute 2nd Wave QRS Volume QRS Sound VF/VT Alarm HR, PR, SpO2, etCO2, RR, APNEA
Select whether or not to enable synchronized cardioversion with the PADDLE lead. Select whether or not to generate heart rate alarms when monitoring ECG with the PADDLE lead. When set to ON, the hum filter automatically reduces AC interference from the ECG. Selects the time constant for ECG display in monitoring mode. When set to ON, it allows correct heart rate counting when the patient has an implanted pacemaker. Select the upper and lower limit of the heart rate alarm. Select the pulse wave sensitivity When set to ON, the pitch of the sync sound changes according to SpO2 value Select the upper and lower limit of the pulse rate alarm. Select the upper and lower limit of the SpO2 alarm. Select the scale of the CO2 waveform Select the upper and lower limit of the etCO2 alarm. Select the upper and lower limit of the respiration rate alarm. Select the upper limit of the APNEA alarm. Select the type of report recording. Select the time length to be recorded in the Trend report recording. Select the measurement interval for Periodic List report recording. Select Yes to delete all report data saved in the instrument. When Yes is selected, further confirmation keys appear. Press the key for Delete to delete all report data. Select the recording interval for the automatic periodic recording. Select the parameter(s) which is recorded in waveform recording, alarm report recording, event recording and automatic recording. Select the date and time. Select the second waveform displayed on the trace 2. Select the QRS sync sound volume. Select the source of the QRS sync sound. Select whether or not to detect VF/VT. Select upper/lower limits for each parameter. (only upper limit for APNEA)
Alarm setup
3.14
How to Change the Settings on the Setup Screen
1. Turn the Energy/Mode Select control to the SETUP position. The Setup Menu screen appears.
VF/VT : In the System Setup screen, the VF/ VT detection function is automatically turned off.
2. Press the Item or Item key to select the setup screen. The selected item is highlighted. Paddle Setup ECG Setup SpO2 Setup CO2 Setup Report Setup Recorder Setup Date/Screen Display Setup Save Report Paddle Setup 3. Press the SET key. The selected setup screen appears. 4. Press the Item key to select the item. 5. Press the or key to set the settings. 6. Repeat steps 2 to 5 to set settings on all setup screen. To return to the Setup - Menu screen, press the Menu key.
3.15
Paddle Setup
Refer to Section 4 Changing Paddle Settings.
ECG Setup
Refer to Section 6 Changing ECG Settings.
SpO2 Setup
Refer to Section 6 Changing SpO2 Settings.
CO2 Setup
Refer to Section 6 Changing CO2 Settings.
Report Setup
Refer to Section 8 Changing Report and Recorder Settings.
Recorder Setup
Refer to Section 8 Changing Report and Recorder Settings.
Date/Screen
On the Date/Screen screen, you can set the date and time and the waveform in second trace.
Date and Time Set the defibrillator date and time.
NOTE
After performing the basic checks, make sure that the date and time printed on the recording paper is correct. The date and time on the recording paper are important parts of the medical record. Setting range Year: 1980 to 2079, Month: 1 to 12, Day: 1 to 31, Hour: 0 to 23, Minute: 0 to 59 3.16 Operator's Manual TEC-5500
3. System Setup Screen and Setup Screen 1. On the Date/Screen screen, select Year, Month, Day, Hour, or Minute with the Item key. 2. Set the date and/or time with the or key. 3. Repeat steps 1 and 2 to set all parameters. 4. Press the Menu key to return to the Setup - Menu screen. You cannot set seconds on this screen. For the most accurate time setting, look at your local clock. Change the minute on the defibrillator and exit the Date/ Screen screen when the minute changes on your local clock. The second count is set to 0 when you exit the Date/Screen screen after changing the minute.
2nd Wave Set the waveform in the second trace.

Setting Trace Acquired parameters
ECG OFF First trace Second trace Bar graph Cascade First trace Second trace Bar graph SpO2 First trace Second trace Bar graph CO2 First trace Second trace Bar graph SpO2/CO2 First trace Second trace Bar graph SpO2/CO2 First trace Second trace Bar graph ECG --None ECG Cascaded ECG None ECG --None ECG --None ECG --None ECG --None
ECG and SpO2 ECG --SpO2 ECG Cascaded ECG SpO2 ECG SpO2 --ECG --SpO2 ECG SpO2 --ECG SpO2 ---
ECG and CO2 ECG --CO2 ECG Cascaded ECG CO2 ECG --CO2 ECG CO2 --ECG CO2 --ECG CO2 ---
ECG, SpO2 and CO2 ECG --SpO2 and CO2 ECG Cascaded ECG SpO2 and CO2 ECG SpO2 CO2 ECG CO2 SpO2 ECG SpO2 CO2 ECG CO2 SpO2
1. On the Date/Screen screen, select 2nd Wave with the Item key. 2. Select the waveform displayed in the second trace with the or key. 3. Press the Menu key to return to the Setup - Menu screen.
QRS Setup
Refer to Section 6 Changing ECG Settings and Changing SpO2 Settings
Alarm Setup
Refer to Section 7 Setting Alarm. 3.17
Save Report
The data of Alarm report recording, Defibrillation report recording, VF Analysis report recording and Event report recording are saved in memory. These data can be saved in a memery card (SD card). The waveform and its information are saved. 1. On the Setup Menu screen, select Save Report and press the SET key. The Save Report screen appears.
The list of saved report data are displayed with the latest one at the top. The selected report data is highlighted. The date includes date and time and report type. Up to five report data are listed on one screen. The Insert SD CARD message appears when a memory card is not inserted into the card slot. When a memory card is already inserted into the card slot, the Wait, searching for data message and the remaining free memory are displayed. 2. Insert the memory card into the card slot. The remaining free memory of the card is displayed on the screen. While the defibrillator is checking the card, the Wait, searching for data message is displayed. When a report data on the screen has already been saved in the inserted memory card, the file name of the report data appears beside the data. To select a report data you want to save, use the or key. When there is more data than currently displayed on the screen, and marks appear above and below the list. To print the selected (highlighted) report data, pressing the Record key. To display the preview waveform of a selected report data, press the Event key. To scroll the waveform, press the or key. To close the preview screen, press the Event key.
3.18
Preview screen 2. Press the Save key. The highlighted data on the Save Report screen is saved in the card and the file name is displayed. When a preview screen is displayed, the data of the displayed waveform is saved. During saving, the Saving dont power off message is displayed. To return to the Setup Menu screen, press the Menu key.
NOTE
Data which has already been saved in the inserted card cannot be saved in the same card. When the memory card is full, the Not enough free memory message appears. In this case, insert another memory card.
3.19
3.20
Section 4 Defibrillation, Synchronized Cardioversion and AED

General About Defibrillation, Synchronized Cardioversion and AED ............................................ Skin-Paddle Contact Impedance .................................................................................... Using the Pediatric Electrode Plate ................................................................................ Changing Paddle Settings .............................................................................................. Turning Synchronized Cardioversion With PADDLE Lead On/Off ........................ Turning Heart Rate Alarm with PADDLE Lead On/Off .......................................... Using the ECG Waveforms from Another Monitor, Paddles or Disposable Pads for Synchronized Cardioversion ........................................................................................... ECG Input from Another Monitor .......................................................................... ECG Input from External Paddles, Internal Paddles and Disposable Pads .......... 4.0.1 4.0.2 4.0.3 4.0.4 4.0.4 4.0.5 4.0.6 4.0.6 4.0.8
Defibrillation Defibrillation Screen ........................................................................................................ 4.1.1 Defibrillation with External Paddles ................................................................................. 4.1.2 Important Safety Information ................................................................................ 4.1.2 Procedure ............................................................................................................. 4.1.3 Defibrillation with Disposable Pads ................................................................................. 4.1.8 Important Safety Information ................................................................................ 4.1.8 Procedure ............................................................................................................. 4.1.9 Defibrillation with Internal Paddles ................................................................................ 4.1.15 Important Safety Information .............................................................................. 4.1.15 Procedure ........................................................................................................... 4.1.16 Synchronized Cardioversion Synchronized Cardioversion Screen .............................................................................. 4.2.1 Synchronized Cardioversion with External Paddles ....................................................... 4.2.2 Important Safety Information ................................................................................ 4.2.2 Procedure ............................................................................................................. 4.2.3 Synchronized Cardioversion with Disposable Pads ........................................................ 4.2.9 Important Safety Information ................................................................................... 4.2.9 Procedure ............................................................................................................. 4.2.11 Synchronized Cardioversion with Internal Paddles .......................................................... 4.2.17 Important Safety Information ................................................................................. 4.2.17 Procedure ............................................................................................................. 4.2.18 Operator's Manual TEC-5500 4C.1
AED AED Screen .................................................................................................................... 4.3.1 Important Safety Information........................................................................................... 4.3.2 AED Flowchart ................................................................................................................ 4.3.4 Preparation for AED Mode .................................................................................... 4.3.5 AED Procedure ............................................................................................................... 4.3.6 When Nonshockable Rhythm Is Detected In AED Analysis ................................ 4.3.15
4C.2
General
About Defibrillation, Synchronized Cardioversion and AED .............................................. 4.0.1 Skin-Paddle Contact Impedance ...................................................................................... 4.0.2 Using the Pediatric Electrode Plate .................................................................................. 4.0.3 Changing Paddle Settings ................................................................................................. 4.0.4 Turning Synchronized Cardioversion With PADDLE Lead On/Off ............................ 4.0.4 Turning Heart Rate Alarm with PADDLE Lead On/Off ............................................. 4.0.5 Using the ECG Waveforms from Another Monitor, Paddles or Disposable Pads for Synchronized Cardioversion ............................................................................................. 4.0.6 ECG Input from Another Monitor ............................................................................ 4.0.6 ECG Input from External Paddles, Internal Paddles and Disposable Pads ............. 4.0.8
4.0C.1
4.0C.2
4. DEFIBRILLATION, SYNCHRONIZED CARDIOVERSION and AED
About Defibrillation, Synchronized Cardioversion and AED

This section explains the procedures to perform defibrillation, synchronized cardioversion and AED. You can use external paddles, internal paddles and disposable pads for defibrillation and synchronized cardioversion. You can use only disposable pads for AED.
WARNING
The defibrillator generates high voltage. The defibrillator must only be operated by trained and qualified medical personnel.
NOTE
Even if a defibrillation or cardioversion is performed on a patient appropriately, the patient may get skin burn. Defibrillation Used for terminating fatal arrhythmias, such as ventricular fibrillation and pulseless ventricular tachycardia. Energy is discharged asynchronously. Synchronized cardioversion Used for eliminating atrial fibrillation and atrial flutter. The defibrillator detects the patients ECG and energy is discharged at an appropriate timing. AED The defibrillator analyzes the patients ECG. When the defibrillator detects a shockable rhythm, it automatically starts charging the selected energy. Discharging is not performed automatically.
4.0.1
Skin-Paddle Contact Impedance

To perform effective defibrillation or cardioversion, it is important to make the skin-paddle contact impedance as low as possible. Recommended applied pressure on a paddle is about 100 N (10kg, 22lb.) per paddle. For this defibrillator, the CONTACT lamp on the STERNUM paddle indicates skinpaddle contact impedance. 0 to 100: green lamp lights 100 to 200: yellow lamp lights more than 200: orange lamp lights Place the paddles so that the green lamp lights. If the green lamp does not light, do the following. Apply the contact gel on the paddles uniformly. Clip hair on the skin where paddles are placed. Press the paddles against the patient and gradually increase the pressure until the green lamp lights. For a patient with chest hair, old patient with skin cornification (hardening) or thin patient, the green lamp does not light. You can discharge energy when the lamp is yellow or orange.
WARNING
In Case of Poor Contact If the yellow or orange lamp lights, the defibrillator may cause serious electric burn on the patients skin and poor energy discharge to the patient. In case of an emergency, medical personnel should decide whether to execute discharge immediately, regardless of the CONTACT lamp display, or take action to make good contact before discharge.
4.0.2
Using the Pediatric Electrode Plate

The pediatric electrode plate is underneath the adult electrode plate of the external paddle. You can also attach the optional pediatric electrode assy 44 mm dia. on the pediatric electrode plate of the external paddle.
WARNING
Pay careful attention to the selected energy when using the pediatric electrode plates. Applying high energy with the pediatric electrode plates can cause skin burn because the electrode plates are small.
The current density on the pediatric electrode plates is higher than the current density on the adult electrode plates because the pediatric electrode plates are smaller* than the adult electrode plates. This increases the possibility of electrical burn on the electrode plate placement area. The minimum effective energy should be set. * The pediatric electrode plates underneath the adult electrode plates are about 1/3 the surface area of the adult electrode plates. The pediatric electrodes assy 44 mm dia. are about 1/5 the surface area of the adult electrode plates. To remove the adult electrode plate: 1. Turn the Energy/Mode select control to the OFF position.
NOTE
While the Shutdown NOW message is displayed on the screen, do not disconnect the power cord from the defibrillator or AC outlet and do not remove the battery pack from the defibrillator. Otherwise, the internal data may be damaged. 2. Press the tab of the adult electrode plate to unlock the adult electrode plate. 3. Slide the adult electrode plate forward and off.
4.0.3
Changing Paddle Settings

Turning Synchronized Cardioversion With PADDLE Lead On/Off
Select whether or not to allow synchronized cardioversion with the PADDLE lead. ON: Synchronized cardioversion with PADDLE lead is available. OFF Synchronized cardioversion with PADDLE lead is not available (Default setting: OFF).
WARNING
Use the ECG monitoring electrodes (disposable electrodes) to monitor the ECG waveforms. Stable ECG cannot be acquired with the PADDLE lead because it is difficult to hold the paddles stable. Also, ECG waveform is unstable after discharge because polarization voltage is very high. Do not perform synchronized cardioversion with the PADDLE lead unless it is absolutely necessary. In synchronized cardioversion with the PADDLE lead, noise may be misrecognized as QRS and discharge might not synchronize with the patients QRS.
NOTE
Firmly connect the disposable pads to the pad adaptor until the connector of the disposable pads clicks. If the pads are not attached firmly or the pads are not connected to the pad adaptor, noise appears on the ECG waveform.
1. On the Paddle Setup screen, select Sync by paddle lead with the Item key.
VF/VT : In the System Setup screen, the VF/ VT detection function is automatically turned off.
2. Select ON or OFF with the or key.
4.0.4
Turning Heart Rate Alarm with PADDLE Lead On/Off
Select whether or not to generate heart rate alarms when monitoring ECG with the PADDLE lead. ON: Heart rate alarms are generated when monitoring ECG with the PADDLE lead. For long term monitoring using disposable pads, set this to ON. OFF : Heart rate alarms are not generated when monitoring ECG with the PADDLE lead. When you use external paddles or internal paddles, set this to OFF (Default setting: OFF). 1. On the Paddle Setup screen, select Heart rate alarm with paddle lead with the Item key.
2.
Select ON or OFF with the or key.
4.0.5
Using the ECG Waveforms from Another Monitor, Paddles or Disposable Pads for Synchronized Cardioversion
You can acquire ECG waveforms for synchronized cardioversion by the following three ways. From the ECG connection cable and ECG disposable electrode. From another monitor From external paddles, internal paddles or disposable pads
ECG Input from Another Monitor
When the patient is already connected to a monitor, it may be possible to use the ECG signal from the monitor, but, this is not recommended.
WARNING
If you use the ECG signal from the monitor, before cardioversion, check that the defibrillator discharge occurs within 60 ms of the peak of the ECGs R wave with a delivery checker. If this condition is not met, the cardioversion may be ineffective or may cause ventricular fibrillation.
CAUTION
The external instrument must comply with the CISPR 11 Second Edition 1990-09, Group 1 and Class B standard.
NOTE
When receiving the ECG signal from a bedside monitor, select lead II or I on the bedside monitor. To use ECG signal from another monitor as the synchronizing signal of synchronized cardioversion Connect the defibrillator to the other instrument with the optional JC-761V External ECG cable. Select AUX for ECG lead.
4.0.6
4. DEFIBRILLATION, SYNCHRONIZED CARDIOVERSION and AED Use the following procedure to check whether or not synchronized cardioversion can be performed with the ECG signal from another instrument. 1. Connect the defibrillator to the other instrument with the optional JC-761V External ECG cable. 2. Turn the power of the other instrument on. 3. Turn the Energy/Mode Select control to the DISARM position.
4. Select AUX with the ECG lead key. 5. Connect an delivery checker to the other instrument and turn the delivery checker on to generate ECG signals. 6. Turn the Energy/Mode Select control to 50 J. 7. Press the SYNC button on the front panel. 8. Check that the mark appears on the rising slope of every QRS wave. 9. Leaving the paddles on the holders of the delivery checker, press the CHARGE button on the APEX paddle to start charging. During charging, there is a beeping sound, a CHARGING message appears, and the CHARGE lamps on the APEX paddle. When charging is completed, there is a continuous buzzing sound, the CHARGED message appears, and the CHARGE lamps light.
JC-761V External ECG cable
red black
Connects to output signal line
Connects to GND line
10. Simultaneously press and hold both DISCHARGE buttons on the external paddles.
4.0.7
ECG Input from External Paddles, Internal Paddles and Disposable Pads
The defibrillator can perform synchronized cardioversion with the PADDLE lead. To use ECG from external paddles, internal paddles or disposable pads for synchronizing signal of synchronized cardioversion, Set the Sync by paddle lead on the Paddle Setup screen to ON Select PADDLE for ECG lead.
WARNING
Do not perform synchronized cardioversion with the PADDLE lead unless it is absolutely necessary. In synchronized cardioversion with the PADDLE lead, noise may be misrecognized as QRS and discharge might not synchronize with the patients QRS.
NOTE
Place the paddles on the patient so that the whole waveform is displayed on the screen and the T waveform is not much higher than the QRS waveform. Otherwise, QRS cannot be recognized correctly. If the defibrillator miscounts the narrow width QRS, set Pacing Pulse Reject to OFF on the ECG Setup screen and confirm that QRS is correctly recognized.
4.0.8
Defibrillation
Defibrillation Screen ......................................................................................................... 4.1.1 Defibrillation with External Paddles ................................................................................... 4.1.2 Important Safety Information ................................................................................. 4.1.2 Procedure ............................................................................................................... 4.1.3 Defibrillation with Disposable Pads ................................................................................... 4.1.8 Important Safety Information ................................................................................. 4.1.8 Procedure ............................................................................................................... 4.1.9 Defibrillation with Internal Paddles .................................................................................. 4.1.15 Important Safety Information ............................................................................... 4.1.15 Procedure ............................................................................................................. 4.1.16
4.1C.1
4.1C.2
Defibrillation Screen
Screen Example ECG lead QRS sync mark AC power operation Number of discharges
Heart rate
Highlighted when it exceeds the upper or lower alarm limit.
Sensitivity ECG
Charged energy
4.1.1
Defibrillation with External Paddles

WARNING
Before defibrillation, make sure that no one is in contact with either the patient or any metal part of any equipment or cables which supports or is connected to the patient. Failure to follow this warning causes serious electrical shock or injury. Before defibrillation, remove from the patient all electrodes, probes and transducers from a connector that do not have a or mark. Otherwise, the operator may receive electrical shock and the connected instrument may be damaged. Before defibrillation, remove everything (electrodes, patches, etc.) from the patients chest. When the defibrillator paddle directly contacts these materials, the discharged energy may cause skin burn to the patient. Before defibrillation, check that the cords and cables of the electrodes, probes and transducers attached to the patient are properly connected to a connector that has a or mark. Touching the metal parts of the disconnected cords and cables may cause electrical shock or injury by discharged energy. When using an ESU, use this defibrillator only in the MONITOR mode and use the ECG electrodes for monitoring. Do not monitor ECG with disposable pads, external paddles or internal paddles. If ECG is monitored with pads or paddles, high frequency energy from the ESU causes abnormal current to flow in the patient and unexpected discharge. This may damage the defibrillator. Use the ECG monitoring electrodes (disposable electrodes) to monitor the ECG waveforms. Stable ECG cannot be acquired with the PADDLE lead because it is difficult to hold the paddles stable. ECG acquired from external paddles, internal paddles or disposable pads is unstable after discharge because of high polarization voltage. Do not perform defibrillation in a wet place. Before defibrillation, move the patient and defibrillator to a dry place. Otherwise the operator may get electrical shock. The defibrillator must only be operated by trained and qualified medical personnel.
NOTE
Select the appropriate energy and appropriate size of the external paddles according to the patient. Only use the paddles specified by Nihon Kohden. Defibrillation is not available when any setup screen or system setup screen is displayed. Before using the defibrillator, confirm and set the necessary settings on the Setup screen and System Setup Configuration screen. Operator's Manual TEC-5500
4.1.2
Procedure
1. Check that the external paddles are connected to the defibrillator.
2. Turn the Energy/Mode Select control to the DISARM position to turn the power on. Confirm that there is no error message on the screen. For error messages, refer to Section 9. When operating with AC power, confirm that the AC lamp is on.
3. Confirm that the ECG lead is set to PADDLE. If another lead is selected, select PADDLE with the ECG lead key.
4. Confirm that the SYNC lamp is not lit. If this lamp is lit, press the SYNC button on the front panel to turn it off.
5. Prepare the paddles 1) Remove the external paddles from their holders by grasping the handles and lifting straight up. 2) Apply contact gel to the electrode plate surface of each paddle. 3) Gently rub the electrode plate surfaces together to evenly spread the gel.
WARNING
Apply contact gel only to the electrode plates of the external paddles. Otherwise, it may cause electrical shock to the operator. Do not apply contact gel by hand. Failure to follow this warning may cause serious electrical burn, shock, or other injury. Do not hold the paddle handles if your hands are wet or have contact gel on them. This may cause electrical shock to the operator. To avoid skin burn on the patient and poor energy discharge to the heart, apply contact gel to the electrode plates of the external paddles.
6. Select the energy level Turn the Energy/Mode Select control to the desired energy position.
4.1.3
4. DEFIBRILLATION, SYNCHRONIZED CARDIOVERSION and AED 7. Place the paddles on the patient
WARNING
Do not touch the electrode plate or edge of the paddle. Failure to follow this warning may cause serious electrical burn, shock, or other injury.
CAUTION
If the patients body is wet, thoroughly wipe the moisture off the skin so that the paddles do not short to each other.
Position 1) Place the left (STERNUM) paddle on the right side of sternum and below the clavicle. 2) Place the right (APEX) paddle on the level of fifth intercostal space and midaxillary line. When using the paddle lead, keep the paddles steady.
NOTE
Do not lean against the paddles when pressing them on the patient. A paddle may slip and cause injury.
STERNUM
APEX
8. Check the ECG waveform Confirm that the patients ECG has a shockable rhythm, such as ventricular fibrillation or pulseless ventricular tachycardia. If the patients ECG requires synchronized cardioversion, follow the procedure in Synchronized Cardioversion in this section.
4.1.4
9. Charge the energy When it is verified that the patient needs defibrillation, press the CHARGE button on the APEX paddle or CHARGE/AED button on the front panel to start charging.
WARNING
Bad example When charging or discharging, do not touch anything other than the handles. If any other part of the defibrillator is touched during charging or discharging, the operator receives an electrical shock. Do not move the defibrillator when any charged energy remains in the defibrillator. If the defibrillator receives any impact, such as from falling, it discharges energy that can cause electrical shock.
During charging, there is a beeping sound, the CHARGING message appears on the screen, and the CHARGE lamp blinks.
When charging is completed, there is a continuous buzzing sound, the CHARGED message appears on the screen, and the CHARGE lamp lights.
To change the energy level after charging is completed Turn the Energy/Mode Select control to the desired energy position. The defibrillator starts adjusting the energy one second after the new energy is selected. When defibrillation becomes unnecessary after charging is completed Turn the Energy/Mode Select control to the DISARM position or OFF position. The defibrillator internally discharges charged energy within 20 seconds. The defibrillator automatically internally discharges charged energy when the charge holding time passes. This time is selected on the System Setup Configuration screen. 10. Check the skin-paddle contact impedance The skin-paddle contact impedance is indicated by the CONTACT lamp on the STERNUM external paddle. Press the paddles against the paddle placement area so that the green lamp lights. Refer to Skin-Paddle Contact Impedance in this section. Operator's Manual TEC-5500 4.1.5
4. DEFIBRILLATION, SYNCHRONIZED CARDIOVERSION and AED 11. Discharge the energy to the patient After confirming that the CHARGE lamp is lit, simultaneously press both DISCHARGE buttons on the paddles to discharge the energy to the patient.
DISCHARGE button
DISCHARGE button
WARNING
Make sure that no one is in contact with either the patient or any equipment which supports or is connected to the patient. Before discharging, confirm that the paddles are firmly pressed against the chest wall. Failure to follow this warning causes skin burn or poor energy discharge to the heart. Never discharge near a person or object other than the patient or test electrode plate or energy checker. It may cause electrical shock to the person or damage the object. Do not discharge with the paddles in the air. This may cause electrical shock to the operator or damage the defibrillator. Do not discharge the energy if the paddles are shorted to each other by contact gel. It may cause skin burn and poor energy discharge to the heart.
Bad example
CAUTION
Do not discharge when the paddles touch each other. This may damage the defibrillator.
12. If another defibrillation is required, perform necessary medical treatment and repeat steps 5 to 11. Use the edge around each paddle holder to temporarily hold the paddles so that contact gel does not get on the defibrillator. These holders can only be used for the adult electrode plates.
4.1.6
4. DEFIBRILLATION, SYNCHRONIZED CARDIOVERSION and AED 13. Turn the power off Turn the Energy/Mode Select control to the OFF position to turn the defibrillator power off.
NOTE
While the Shutdown NOW message is displayed on the screen, do not disconnect the power cord from the defibrillator or AC outlet and do not remove the battery pack from the defibrillator. Otherwise, the internal data may be damaged. Thoroughly wipe off the contact gel from the external paddles and defibrillator. Refer to Cleaning, Disinfecting and Sterilization in Section 10. Put the external paddles on the paddle holders by pressing the paddles onto the holders.
4.1.7
Defibrillation with Disposable Pads

WARNING
Before defibrillation, make sure that no one is in contact with either the patient or any metal part of any equipment or cables which supports or is connected to the patient. Failure to follow this warning causes serious electrical shock or injury. Before defibrillation, remove from the patient all electrodes, probes and transducers from a connector that do not have a or mark. Otherwise, the operator may receive electrical shock and the connected instrument may be damaged. Before defibrillation, remove everything (electrodes, patches, etc.) from the patients chest. When the defibrillator paddle directly contacts these materials, the discharged energy may cause skin burn to the patient. Before defibrillation, check that the cords and cables of the electrodes, probes and transducers attached to the patient are properly connected to a connector that has a or mark. Touching the metal parts of the disconnected cords and cables may cause electrical shock or injury by discharged energy. When using an ESU, use this defibrillator only in the MONITOR mode and use the ECG electrodes for monitoring. Do not monitor ECG with disposable pads, external paddles or internal paddles. If ECG is monitored with pads or paddles, high frequency energy from the ESU causes abnormal current to flow in the patient and unexpected discharge. This may damage the defibrillator. Use the ECG monitoring electrodes (disposable electrodes) to monitor the ECG waveforms. Stable ECG cannot be acquired with the PADDLE lead because it is difficult to hold the paddles stable. ECG acquired from external paddles, internal paddles or disposable pads is unstable after discharge because of high polarization voltage. The defibrillator must only be operated by trained and qualified medical personnel. Failure to follow the warnings below may cause skin burn or insufficient energy discharge and insufficient pacing current to the heart. - Do not reuse disposable pads. - If the pad package is torn, dispose of the pads and do not use them. - Do not use the pads if they are past the expiration date on the package. - Use the disposable pads as soon as possible after opening the package. - Do not use the disposable pads if the gel has become dry or if the gel has become abnormal (the gel has become liquid or is coming Operator's Manual TEC-5500
4.1.8
4. DEFIBRILLATION, SYNCHRONIZED CARDIOVERSION and AED off the edges of the pad, etc). - Do not use the disposable pads if the gel is dark brown or dark brown gel is on the protective sheet. If any pad or connector gets wet, replace it with a new one. If a wet pad or connector is used, it may cause electrical shock. Do not perform defibrillation in a wet place. Before defibrillation, move the patient and defibrillator to a dry place. Otherwise the operator may get electrical shock.
CAUTION
NOTE
Follow all disposable pad labeling instructions. Always prepare the second set of disposable pads before defibrillation. Use the second set of disposable pads if the gel of the first set of disposable pads is dry, deteriorated or changes color. Before attaching the disposable pads to the patient, clean the skin where the pads will be attached. If the skin is moist, use a cotton swab to dry it. Only use the pads specified by Nihon Kohden. Defibrillation is not available when any Setup screen or System Setup screen is displayed. Before using the defibrillator, confirm and set the necessary settings on the Setup screen and System Setup Configuration screen.
Procedure
1. Connect the pad adaptor to the defibrillator. 1) Press the paddle release knob of the paddle connector on the front panel and remove the external paddles from the paddle connector..
4.1.9
4. DEFIBRILLATION, SYNCHRONIZED CARDIOVERSION and AED 2) Connect the pad adaptor to the paddle connector until it clicks.
CAUTION
When connecting the pad adapter to the paddle connector, do not bend or damage the connector pin. Energy cannot be discharged to the pads.
2. Turn the Energy/Mode Select control to the DISARM position to turn the power on. Confirm that there is no error message on the screen. For error messages, refer to Section 9. When operating with AC power, confirm that the AC lamp is on.
3. Confirm that the ECG lead is set to PADDLE. If another lead is selected, select PADDLE with the ECG lead key. 4. Confirm that the SYNC lamp is not lit. If this lamp is lit, press the SYNC button on the front panel to turn it off. 5. Prepare the disposable pads. 1) To allow firm pad contact with the skin, clean the patients chest to remove oil and dirt, and thoroughly dry the skin. Clip excessive hair, if necessary.
NOTE
Do not apply any gel or paste when using disposable pads. 2) Take the disposable pads out of the package and carefully remove the protective liner from one pad at a time.
3) Attach the pads to the patients body, one at a time. 4.1.10 Operator's Manual TEC-5500
WARNING
Do not attach pads on the papilla, electrodes or medicine on the patients body. Failure to follow this warning causes serious skin burn. Fit the pad closely to the body surface so that current flows uniformly through the pad. Failure to follow this warning causes serious skin burn or insufficient energy discharge to the heart.
CAUTION
NOTE
When the skin-pad contact is poor, it causes high electrode impedance and energy cannot be charged.
Apex-Anterior placement RA: LL: Right side of sternum and below the clavicle On the level of fifth intercostal space and midaxillary line
Apex-Posterior placement RA: Between right scapula and spine LL: On the level of fifth intercostal space and midaxillary line
4.1.11
4. DEFIBRILLATION, SYNCHRONIZED CARDIOVERSION and AED 4) Connect the disposable pads to the pad adaptor.
NOTE
Firmly connect the disposable pads to the pad adaptor until the connector of the disposable pads clicks. When the Change disposable pads message appears, the pads may be faulty. Replace them with new ones. If the message still appears, stop using the defibrillator and use a different defibrillator. 6. Check the ECG waveform Confirm that the patients ECG has a shockable rhythm, such as ventricular fibrillation or pulseless ventricular tachycardia. If the patients ECG requires synchronized cardioversion, follow the procedure in Synchronized Cardioversion in this section. 7. Select the energy level Turn the Energy/Mode Select control to the desired energy position. 8. Charge the energy When it is verified that the patient needs defibrillation, press the CHARGE/ AED button on the front panel to start charging.
WARNING
During charging or discharging, do not touch the pads or connectors. Failure to follow this warning causes electrical shock to the operator. Do not move the defibrillator when any charged energy remains in the defibrillator. If the defibrillator receives any impact, such as from falling, it discharges energy that can cause electrical shock.
NOTE
If the CHARGE/AED button is pressed when a disposable pad is detached from the patient, charging does not start. If a disposable pad is detached during or after charging, the defibrillator automatically discharges energy internally within 20 seconds.
4.1.12
4. DEFIBRILLATION, SYNCHRONIZED CARDIOVERSION and AED During charging, there is a beeping sound, the CHARGING message appears on the screen.
When charging is completed, there is a continuous buzzing sound, the CHARGED message appears on the screen, and the DISCHARGE lamp blinks.
To change the energy level after charging is completed Turn the Energy/Mode Select control to the desired energy position. The defibrillator starts adjusting the energy one second after the new energy is selected. When defibrillation becomes unnecessary after charging is completed Turn the Energy/Mode Select control to the DISARM position or OFF position. The defibrillator internally discharges charged energy within 20 seconds. The defibrillator automatically internally discharges charged energy when the charge holding time has passed. This time is selected on the System Setup Configuration screen. 9. Discharge the energy to the patient After confirming that the DISCHARGE lamp blinks, press the DISCHARGE button on the front panel to discharge the energy to the patient.
WARNING
Before discharging, confirm that the pads are firmly applied to the chest wall. Failure to follow this warning causes skin burn or poor energy discharge to the heart. Do not discharge if the pads overlap each other or are shorted to each other by anything conductive such as contact gel. This may cause skin burn and poor energy discharge to the heart. Make sure that no one is in contact with either the patient or any equipment which supports or is connected to the patient.
10. If another defibrillation is required, perform necessary medical treatment and repeat steps 7 to 9.
4.1.13
4. DEFIBRILLATION, SYNCHRONIZED CARDIOVERSION and AED 11. Turn the power off Turn the Energy/Mode Select control to the OFF position.
NOTE
While the Shutdown NOW message is displayed on the screen, do not disconnect the power cord from the defibrillator or AC outlet and do not remove the battery pack from the defibrillator. Otherwise, the internal data may be damaged. Press the paddle release knob of the paddle connector to the right and remove the pad adaptor from the paddle connector. Hold the connector part to disconnect the pad adaptor. Otherwise the connector gets damaged and the cable breaks. Dispose of the disposable pads. Refer to Cleaning, Disinfecting and Sterilization in Section 10.
4.1.14
Defibrillation with Internal Paddles

By directly applying the internal paddles to the heart, defibrillation during open chest operation is available.
WARNING
Before defibrillation, make sure that no one is in contact with either the patient or any metal part of any equipment or cables which supports or is connected to the patient. Failure to follow this warning causes serious electrical shock or injury. Before defibrillation, remove from the patient all electrodes, probes and transducers from a connector that do not have a or mark. Otherwise, the operator may receive electrical shock and the connected instrument may be damaged. Before defibrillation, remove everything (electrodes, patches, etc.) from the patients chest. When the defibrillator paddle directly contacts these materials, the discharged energy may cause skin burn to the patient. Before defibrillation, check that the cords and cables of the electrodes, probes and transducers attached to the patient are properly connected to a connector that has a or mark. Touching the metal parts of the disconnected cords and cables may cause electrical shock or injury by discharged energy. When using an ESU, use this defibrillator only in the MONITOR mode and use the ECG electrodes for monitoring. Do not monitor ECG with disposable pads, external paddles or internal paddles. If ECG is monitored with pads or paddles, high frequency energy from the ESU causes abnormal current to flow in the patient and unexpected discharge. This may damage the defibrillator. Use the ECG monitoring electrodes (disposable electrodes) to monitor the ECG waveforms. Stable ECG cannot be acquired with the PADDLE lead because it is difficult to hold the paddles stable. ECG acquired from external paddles, internal paddles or disposable pads is unstable after discharge because of high polarization voltage. The defibrillator must only be operated by trained and qualified medical personnel. Sterilize the internal paddles before use. Failure to sterilize the paddles may cause serious infection. Pay careful attention to the energy selection when using internal paddles. Applying high energy to the heart may cause cardiac muscle necrosis. Low energy is recommended. Do not perform defibrillation in a wet place. Before defibrillation, move the patient and defibrillator to a dry place. Otherwise the operator may get electrical shock.
4.1.15
CAUTION
Do not twist the internal paddle while holding the electrode or give strong impact to the paddle. It damages the electrode.
NOTE
Select the appropriate energy and appropriate size of the internal paddles according to the patient. Only use the paddles specified by Nihon Kohden. Defibrillation is not available when any Setup screen or System Setup screen is displayed. Before using the defibrillator, confirm and set the necessary settings on the Setup screen and System Setup - Configuration screen.
Procedure
It is reported that the cardiac muscle may necrose if high energy is repeatedly applied to the heart with internal paddles. Refer to Reference in Section 11. 1. Connect the internal paddles to the defibrillator. 1) Press the paddle release knob of the paddle connector to the right and remove the external paddles from the paddle connector.
2) Connect the internal paddles to the paddle connector until it clicks.
CAUTION
Do not bend or damage the connector pins of the paddle connector. Energy cannot be fully discharged if pins are bent or damaged.
4.1.16
4. DEFIBRILLATION, SYNCHRONIZED CARDIOVERSION and AED 2. Turn the Energy/Mode Select control to the DISARM position to turn the power on. Confirm that there is no error message on the screen. For error messages, refer to Section 9. When operating with AC power, confirm that the AC lamp is on.
3. Confirm that the SYNC lamp is not lit. If this lamp is lit, press the SYNC button on the front panel to turn it off. 4. Position the internal paddles Position the sterilized internal paddles against the right and the left atria of the heart.
NOTE
It is not necessary to consider the polarities of the internal paddle electrodes. For better contact between the internal paddles and heart, place sterilized gauze moistened with physiological saline solution between each internal paddle and the heart. 5. Check the ECG waveform Confirm that the patients ECG has a shockable rhythm, such as ventricular fibrillation or pulseless ventricular tachycardia. If the patients ECG requires synchronized cardioversion, follow the procedure in Synchronized Cardioversion in this section. 6. Select the energy level Turn the Energy/Mode Select control to the desired energy position.
When the internal paddles are used, 50 J or below can be selected. If above 50 J is selected, the Set energy to 50 J or less message appears on the screen and the selected energy cannot be charged. 7. Charge the energy When it is verified that the patient needs defibrillation, press the CHARGE/ AED button on the front panel to start charging.
WARNING
During charging and discharging, grip the internal paddles between the guard at the top of the handle and the cable. If you grip the handle between the electrode and the guard, you may get an electrical shock. Do not move the defibrillator when any charged energy remains in the defibrillator. If the defibrillator receives any impact, such as from falling, it discharges energy that can cause electrical shock. guard
4.1.17
To change the energy level after charging is completed Turn the Energy/Mode Select control to the desired energy position. The defibrillator starts adjusting the energy one second after the new energy is selected.
NOTE
If above 50 J is selected, the defibrillator immediately discharges energy internally. When defibrillation becomes unnecessary after charging is completed Turn the Energy/Mode Select control to the DISARM position or OFF position. The defibrillator internally discharges charged energy within 20 seconds. The defibrillator automatically internally discharges charged energy when the charge holding time has passed. This time is selected on the System Setup Configuration screen. 8. Discharge the energy to the patient After confirming that the DISCHARGE lamp blinks, press the DISCHARGE button on the front panel to discharge the energy to the patient. Firmly hold the handles of the internal paddles until discharge finishes.
WARNING
Make sure that no one is in contact with either the patient or any equipment which supports or is connected to the patient. Before discharging, confirm that the paddles are firmly positioned against the heart. Failure to follow this warning causes serious skin burn or poor energy discharge to the heart. Never discharge near a person or object other than the patient or test electrode plate or energy checker. It may cause electrical shock to the person or damage the object. Do not discharge with the paddles in the air. This may cause electrical shock to the operator or damage the defibrillator.
4.1.18
CAUTION
9. If another defibrillation is required, perform necessary medical treatment and repeat steps 6 to 8. 10. Turn the power off Turn the Energy/Mode Select control to the OFF position.
NOTE
While the Shutdown NOW message is displayed on the screen, do not disconnect the power cord from the defibrillator or AC outlet and do not remove the battery pack from the defibrillator. Otherwise, the internal data may be damaged. Press the paddle release knob of the paddle connector to the right and remove the internal paddles from the paddle connector. Hold the connector part to disconnect the paddle connector. Otherwise the connector gets damaged and the cable breaks. Wash off blood from the internal paddles and sterilize them. Refer to Cleaning, Disinfecting and Sterilization in Section 10.
4.1.19
4.1.20
Synchronized Cardioversion
Synchronized Cardioversion Screen ................................................................................. 4.2.1 Synchronized Cardioversion with External Paddles .......................................................... 4.2.2 Important Safety Information ................................................................................. 4.2.2 Procedure ............................................................................................................... 4.2.3 Synchronized Cardioversion with Disposable Pads .......................................................... 4.2.9 Important Safety Information ................................................................................... 4.2.9 Procedure ............................................................................................................. 4.2.11 Synchronized Cardioversion with Internal Paddles .......................................................... 4.2.17 Important Safety Information ............................................................................... 4.2.17 Procedure ............................................................................................................. 4.2.18
4.2C.1
4.2C.2
Synchronized Cardioversion Screen

Screen Example ECG lead QRS sync mark Synchronization point AC power operation Sensitivity
Heart rate
SYNC mode ECG Charged energy
4.2.1
Synchronized Cardioversion with External Paddles

WARNING
Before cardioversion, make sure that no one is in contact with either the patient or any metal part of any equipment or cables which supports or is connected to the patient. Failure to follow this warning causes serious electrical shock or injury. Before cardioversion, remove from the patient all electrodes, probes and transducers from a connector that do not have a or mark. Otherwise, the operator may receive electrical shock and the connected instrument may be damaged. Before cardioversion, remove everything (electrodes, patches, etc.) from the patients chest. When the defibrillator paddle directly contacts these materials, the discharged energy may cause skin burn to the patient. Before cardioversion, check that the cords and cables of the electrodes, probes and transducers attached to the patient are properly connected to a connector that has a or mark. Touching the metal parts of the disconnected cords and cables may cause electrical shock or injury by discharged energy. When using an ESU, use this defibrillator only in the MONITOR mode and use the ECG electrodes for monitoring. Do not monitor ECG with disposable pads, external paddles or internal paddles. If ECG is monitored with pads or paddles, high frequency energy from the ESU causes abnormal current to flow in the patient and unexpected discharge. This may damage the defibrillator. Confirm that there is no noise on the ECG. Noise may be misrecognized as QRS and discharge might not synchronize with the patients QRS. Use the ECG monitoring electrodes (disposable electrodes) to monitor the ECG waveforms. Stable ECG cannot be acquired with the PADDLE lead because it is difficult to hold the paddles stable. ECG acquired from external paddles, internal paddles or disposable pads is unstable after discharge because of high polarization voltage. Do not perform synchronized cardioversion with the PADDLE lead unless it is absolutely necessary. In synchronized cardioversion with the PADDLE lead, noise may be misrecognized as QRS and discharge might not synchronize with the patients QRS. Do not perform cardioversion in a wet place. Before cardioversion, move the patient and defibrillator to a dry place. Otherwise the operator may get electrical shock. The defibrillator must only be operated by trained and qualified medical personnel.
4.2.2
CAUTION
When performing synchronized cardioversion, confirm that the SYNC lamp is lit before every discharge. If Sync mode after CV is set to Defib on the System Setup - Configuration screen, the defibrillator automatically turns to the asynchronous defibrillation mode.
NOTE
Select the appropriate energy and appropriate size of the external paddles according to the patient. Only use the paddles specified by Nihon Kohden. Cardioversion is not available when any Setup screen or System Setup screen is displayed. Before using the defibrillator, confirm and set the necessary settings on the Setup screen and System Setup Configuration screen.
Procedure
1. Check that the external paddles are connected to the defibrillator. 2. Turn the Energy/Mode Select control to the DISARM position to turn the power on. Confirm that there is no error message on the screen. For error messages, refer to Section 9. When operating with AC power, confirm that the AC lamp is on. 3. Prepare the patient to monitor the ECG waveforms. When monitoring ECG waveform with the ECG connection cable and disposable electrodes, 1) Connect the ECG connection cable to the ECG input connector on the front panel. 2) Attach the disposable electrodes to the patient. Refer to Section 4 Preparing for ECG Monitoring. 3) Clip the ECG connection cable to the electrode. Confirm that electrodes are not pulled by the ECG connection cable. To acquire ECG waveform from another monitor, refer to Using the ECG Waveforms from Another Monitor, Paddles or Disposable Pads for Synchronized Cardioversion in this section. 4. Press the ECG lead key to select the lead which has the highest QRS wave. When acquiring synchronizing signal with the ECG connection cable and disposable electrodes, usually II is selected. When using the ECG waveform from another monitor, select AUX.
WARNING
Never select TEST for the ECG lead. TEST is for maintenance and the waveform displayed on the screen is not the patients ECG. If synchronized cardioversion is performed with the TEST lead, the discharge is not synchronized with the patients QRS and it may cause ventricular fibrillation. Operator's Manual TEC-5500 4.2.3
NOTE
Select a lead so that the whole waveform is displayed on the screen and the T waveform is not much higher than the QRS waveform. Otherwise, QRS cannot be recognized correctly. If the defibrillator miscounts the narrow width QRS, set Pacing Pulse Reject to OFF on the ECG Setup screen and confirm that QRS is correctly recognized. 5. Select SYNC mode 1) Press the SYNC button on the front panel to select the synchronized cardioversion mode. Confirm that the SYNC lamp lights and SYNC is displayed on the screen. 2) Check that the mark appears on the rising slope of every QRS wave. The mark indicates that the defibrillator detects the QRS wave. If the mark does not appear, correct synchronization is not available. Do the following to display the mark on the rising slope of every QRS wave: - Change the amplitude of the ECG waveforms with the ECG sensitivity key. - Change the ECG lead with the ECG lead key. - Change the electrode position.
NOTE
When the Energy/Mode Select control is set to MONITOR, AED, DEMAND or FIXED position, the SYNC mode cannot be selected. If the Energy/Mode Select control is set to MONITOR, AED, DEMAND or FIXED position while the SYNC mode is selected (SYNC lamp is lit), the defibrillator exits the SYNC mode. 6. Prepare the paddles 1) Remove the external paddles from their holders by grasping the handles and lifting straight up. 2) Apply contact gel to the electrode plate surface of each paddle. 3) Gently rub the electrode plate surfaces together to evenly spread the gel.
WARNING
Apply contact gel only to the electrode plates of the external paddles. Otherwise, it may cause electrical shock to the operator. Do not apply contact gel by hand. Failure to follow this warning may cause serious electrical burn, shock, or other injury. Do not hold the paddle handles if your hands are wet or have contact gel on them. This may cause electrical shock to the operator. To avoid skin burn on the patient and poor energy discharge to the heart, apply contact gel to the electrode plates of the external paddles.
4.2.4
4. DEFIBRILLATION, SYNCHRONIZED CARDIOVERSION and AED 7. Select the energy level Turn the Energy/Mode Select control to the desired energy position. 8. Place the paddles on the patient
WARNING
Do not touch the electrode plate or edge of the paddle. Failure to follow this warning may cause serious electrical burn, shock, or other injury.
CAUTION
Position 1) Place the left (STERNUM) paddle on the right side of sternum and below the clavicle. 2) Place the right (APEX) paddle on the level of fifth intercostal space and midaxillary line. When using the paddle lead, keep the paddles steady.
NOTE
Do not lean against the paddles when pressing them on the patient. A paddle may slip and cause injury.
STERNUM
APEX
4.2.5
4. DEFIBRILLATION, SYNCHRONIZED CARDIOVERSION and AED 9. Charge the energy When it is verified that the patient needs synchronized cardioversion, press the CHARGE button on the APEX paddle or CHARGE/AED button on the front panel to start charging.
WARNING
Bad example When charging or discharging, do not touch anything other than the handles. If any other part of the defibrillator is touched during charging or discharging, the operator receives an electrical shock. Do not move the defibrillator when any charged energy remains in the defibrillator. If the defibrillator receives any impact, such as from falling, it discharges energy that can cause electrical shock.
During charging, there is a beeping sound, the CHARGING message appears on the screen.
To change the energy level after charging is completed Turn the Energy/Mode Select control to the desired energy position. The defibrillator starts adjusting the energy one second after the new energy is selected. When cardioversion becomes unnecessary after charging is completed Turn the Energy/Mode Select control to the DISARM position or OFF position. The defibrillator internally discharges charged energy within 20 seconds. The defibrillator automatically internally discharges charged energy when the charge holding time has passed. This time is selected on the System Setup Configuration screen. 10. Check the skin-paddle contact impedance The skin-paddle contact impedance is indicated by the CONTACT lamp on the STERNUM external paddle. Press the paddles against the paddle placement area so that the green lamp lights. Refer to Skin-Paddle Contact Impedance in this section. 4.2.6 Operator's Manual TEC-5500
4. DEFIBRILLATION, SYNCHRONIZED CARDIOVERSION and AED 11. Discharge the energy to the patient After confirming that the DISCHARGE lamp blinks and the SYNC lamp lights, press the DISCHARGE buttons on the paddles to discharge the energy to the patient. Hold the buttons pressed until energy is discharged. DISCHARGE button
DISCHARGE button
WARNING
Make sure that no one is in contact with either the patient or any equipment which supports or is connected to the patient. Before discharging, confirm that the paddles are firmly pressed against the chest wall. Failure to follow this warning causes skin burn or poor energy discharge to the heart. Do not discharge near a person or object other than the patient or test electrode plate or energy checker. This may cause electrical shock to the person or object. Do not discharge with the paddles in the air. This may cause electrical shock to the operator or damage the defibrillator. Do not discharge the energy if the paddles are shorted to each other by contact gel. It may cause skin burn and poor energy discharge to the heart.
Bad example
CAUTION
12. If another cardioversion is required, perform necessary medical treatment and repeat steps 5 and 7 to 11. Use the edge around each paddle holders to temporarily hold the paddles so that contact gel does not get on the defibrillator. These holders can only be used for the adult electrode plate.
4.2.7
4. DEFIBRILLATION, SYNCHRONIZED CARDIOVERSION and AED 13. Turn the power off Turn the Energy/Mode Select control to the OFF position to turn the defibrillator power off.
NOTE
While the Shutdown NOW message is displayed on the screen, do not disconnect the power cord from the defibrillator or AC outlet and do not remove the battery pack from the defibrillator. Otherwise, the internal data may be damaged. Thoroughly wipe off the contact gel from the external paddles and defibrillator. Refer to Cleaning, Disinfecting and Sterilization in Section 10. Put the external paddles to the paddle holders by pressing the paddles onto the holders.
4.2.8
Synchronized Cardioversion with Disposable Pads

WARNING
Before cardioversion, make sure that no one is in contact with either the patient or any metal part of any equipment or cables which supports or is connected to the patient. Failure to follow this warning causes serious electrical shock or injury. Before cardioversion, remove from the patient all electrodes, probes and transducers from a connector that do not have a or mark. Otherwise, the operator may receive electrical shock and the connected instrument may be damaged. Before cardioversion, remove everything (electrodes, patches, etc.) from the patients chest. When the defibrillator paddle directly contacts these materials, the discharged energy may cause skin burn to the patient. Before cardioversion, check that the cords and cables of the electrodes, probes and transducers attached to the patient are properly connected to a connector that has a or mark. Touching the metal parts of the disconnected cords and cables may cause electrical shock or injury by discharged energy. When using an ESU, use this defibrillator only in the MONITOR mode and use the ECG electrodes for monitoring. Do not monitor ECG with disposable pads, external paddles or internal paddles. If ECG is monitored with pads or paddles, high frequency energy from the ESU causes abnormal current to flow in the patient and unexpected discharge. This may damage the defibrillator. Use the ECG monitoring electrodes (disposable electrodes) to monitor the ECG waveforms. Stable ECG cannot be acquired with the PADDLE lead because it is difficult to hold the paddles stable. ECG acquired from external paddles, internal paddles or disposable pads is unstable after discharge because of high polarization voltage. Confirm that there is no noise on the ECG. Noise may be misrecognized as QRS and discharge might not synchronize with the patients QRS. The defibrillator must only be operated by trained and qualified medical personnel. Failure to follow the warnings below may cause skin burn or insufficient energy discharge and insufficient pacing current to the heart. - Do not reuse disposable pads. - If the pad package is torn, dispose of the pads and do not use them. - Do not use the pads if they are past the expiration date on the package.
4.2.9
WARNING continued
- Use the disposable pads as soon as possible after opening the package. - Do not use the disposable pads if the gel has become dry or if the gel has become abnormal (the gel has become liquid or is coming off the edges of the pad, etc). - Do not use the disposable pads if the gel is dark brown or dark brown gel is on the protective sheet. If any pad or connector gets wet, replace it with a new one. If a wet pad or connector is used, it may cause electrical shock. Do not cardioversion in a wet place. Before cardioversion, move the patient and defibrillator to a dry place. Otherwise the operator may get electrical shock.
CAUTION
When using the disposable pads for long term ECG monitoring, replace them every 24 hours. Failure to follow this instruction may cause insufficient pacing current and insufficient energy discharge to the heart. Do not attach a disposable pad over another pad. It may cause skin burn on the patient. When performing synchronized cardioversion, confirm that the SYNC lamp is lit before every discharge. If Sync mode after CV is set to Defib on the System Setup - Configuration screen, the defibrillator automatically turns to the asynchronous defibrillation mode. Do not put heavy objects on the disposable pads or bend the pads. If the pads get damaged or deteriorated, it may cause skin burn on the patient.
NOTE
Follow all disposable pad labeling instructions. Always prepare the second set of disposable pads before cardioversion. Use the second set of disposable pads if the gel of the first set of disposable pads is dry, deteriorated or changes color. Before attaching the disposable pads to the patient, clean the skin where the pads will be attached. If the skin is moist, use a cotton swab to dry it. Only use the pads specified by Nihon Kohden. Cardioversion is not available when any Setup screen or System Setup screen is displayed. Previously confirm and set the necessary settings on the Setup screen and System Setup-Configuration screen.
4.2.10
Procedure
1. Connect the pad adaptor to the defibrillator. 1) Press the paddle release knob of the paddle connector on the front panel and remove the external paddles from the paddle connector.
2) Connect the pad adaptor to the paddle connector until it clicks.
CAUTION
2. Turn the Energy/Mode Select control to the DISARM position to turn the power on. Confirm that there is no error message on the screen. For error messages, refer to Section 9. When operating with AC power, confirm that the AC lamp is on. 3. Prepare the patient to monitor the ECG waveforms. When monitoring ECG waveforms with the ECG connection cable and disposable electrodes, 1) Connect the ECG connection cable to the ECG input connector on the front panel. 2) Attach the disposable electrodes to the patient. Refer to Section 4 Preparing for ECG Monitoring. 3) Clip the ECG connection cable to the electrode. Confirm that electrodes are not pulled by the ECG connection cable. To acquire ECG waveforms from another monitor, refer to Using the ECG Waveforms from Another Monitor, Paddles or Disposable Pads for Synchronized Cardioversion in this section.
4.2.11
4. DEFIBRILLATION, SYNCHRONIZED CARDIOVERSION and AED 4. Press the ECG lead key to select the lead which has the highest QRS wave. When acquiring a synchronizing signal with the ECG connection cable and disposable electrodes, usually II is selected. When using the ECG waveform from another monitor, select AUX.
WARNING
Never select TEST for the ECG lead. TEST is for maintenance and the waveform displayed on the screen is not the patients ECG. If synchronized cardioversion is performed with the TEST lead, the discharge is not synchronized with the patients QRS and it may cause ventricular fibrillation.
NOTE
NOTE
When the Energy/Mode Select control is set to MONITOR, AED, DEMAND or FIXED position, the SYNC mode cannot be selected. If the Energy/Mode Select control is set to MONITOR, AED, DEMAND or FIXED position while the SYNC mode is selected (SYNC lamp is lit), the defibrillator exits the SYNC mode.
4.2.12
4. DEFIBRILLATION, SYNCHRONIZED CARDIOVERSION and AED 6. Prepare the disposable pads. 1) To allow firm pad contact with the skin, clean the patients chest to remove oil and dirt, and thoroughly dry the skin. Clip excessive hair, if necessary.
NOTE
3) Attach the pads to the patients body, one at a time.
WARNING
CAUTION
NOTE
When the skin-pad contact is poor, it causes high electrode impedance and energy cannot be charged.
4.2.13
4. DEFIBRILLATION, SYNCHRONIZED CARDIOVERSION and AED Apex-Anterior placement RA: LL: Right side of sternum and below the clavicle On the level of fifth intercostal space and midaxillary line
Apex-Posterior placement RA: LL: Between right scapula and spine On the level of fifth intercostal space and midaxillary line
4) Connect the disposable pads to the pad adaptor.
NOTE
Firmly connect the disposable pads to the pad adaptor until the connector of the disposable pads clicks. When the Change disposable pads message appears, the pads may be faulty. Replace them with new ones. If the message still appears, stop using the defibrillator and use a different defibrillator.
4.2.14
4. DEFIBRILLATION, SYNCHRONIZED CARDIOVERSION and AED 7. Select the energy level Turn the Energy/Mode Select control to the desired energy position. 8. Charge the energy When it is verified that the patient needs synchronized cardioversion, press the CHARGE/AED button on the front panel to start charging.
WARNING
NOTE
If the CHARGE/AED button is pressed when a disposable pad is detached from the patient, charging does not start. If a disposable pad is detached during or after charging, the defibrillator automatically discharges energy internally within 20 seconds. During charging, there is a beeping sound, the CHARGING message appears on the screen.
To change the energy level after charging is completed Turn the Energy/Mode Select control to the desired energy position. The defibrillator starts adjusting the energy one second after the new energy is selected. When cardioversion becomes unnecessary after charging is completed Turn the Energy/Mode Select control to the DISARM position or OFF position. The defibrillator internally discharges charged energy within 20 seconds. Operator's Manual TEC-5500 4.2.15
The defibrillator automatically internally discharges charged energy when the charge holding time has passed. This time is selected on the System Setup Configuration screen.
9. Discharge the energy to the patient After confirming that the DISCHARGE lamp blinks and SYNC lamp lights, press the DISCHARGE button on the front panel to discharge the energy to the patient. Hold the buttons pressed until energy is discharged.
WARNING
Before discharging, confirm that the pads are firmly applied to the chest wall. Failure to follow this warning causes skin burn or poor energy discharge to the heart. Do not discharge if the pads overlap each other or are shorted to each other by anything conductive such as contact gel. This may cause skin burn and poor energy discharge to the heart. Make sure that no one is in contact with either the patient or any equipment which supports or is connected to the patient.
10. If another cardioversion is required, perform necessary medical treatment and repeat steps 5 and 7 to 9.
11. Turn the power off Turn the Energy/Mode Select control to the OFF position.
NOTE
4.2.16
Synchronized Cardioversion with Internal Paddles

By directly applying the internal paddles to the heart, cardioversion during open chest operation is available.
WARNING
Before cardioversion, make sure that no one is in contact with either the patient or any metal part of any equipment or cables which supports or is connected to the patient. Failure to follow this warning causes serious electrical shock or injury. Before cardioversion, remove from the patient all electrodes, probes and transducers from a connector that do not have a or mark. Otherwise, the operator may receive electrical shock and the connected instrument may be damaged. Before cardioversion, remove everything (electrodes, patches, etc.) from the patients chest. When the defibrillator paddle directly contacts these materials, the discharged energy may cause skin burn to the patient. Before cardioversion, check that the cords and cables of the electrodes, probes and transducers attached to the patient are properly connected to a connector that has a or mark. Touching the metal parts of the disconnected cords and cables may cause electrical shock or injury by discharged energy. When using an ESU, use this defibrillator only in the MONITOR mode and use the ECG electrodes for monitoring. Do not monitor ECG with disposable pads, external paddles or internal paddles. If ECG is monitored with pads or paddles, high frequency energy from the ESU causes abnormal current to flow in the patient and unexpected discharge. This may damage the defibrillator. Use the ECG monitoring electrodes (disposable electrodes) to monitor the ECG waveforms. Stable ECG cannot be acquired with the PADDLE lead because it is difficult to hold the paddles stable. ECG acquired from external paddles, internal paddles or disposable pads is unstable after discharge because of high polarization voltage. Confirm that there is no artifact on the ECG. If there is artifact on the ECG, signals other than ECG are misrecognized to be QRS and accidental discharge may occur which is not synchronized with the patients QRS wave. The defibrillator must only be operated by trained and qualified medical personnel. Sterilize the internal paddles before use. Failure to sterilize the paddles may cause serious infection. Pay careful attention to the energy selection when using internal paddles. Applying high energy to the heart may cause cardiac muscle necrosis. Low energy is recommended.
4.2.17
4. DEFIBRILLATION, SYNCHRONIZED CARDIOVERSION and AED Warning - continued Do not perform cardioversion in a wet place. Before cardioversion, move the patient and defibrillator to a dry place. Otherwise the operator may get electrical shock.
CAUTION
Do not twist the internal paddle while holding the electrode or give strong impact to the paddle. It damages the electrode. When performing synchronized cardioversion, confirm that the SYNC lamp is lit before every discharge. If Sync mode after CV is set to Defib on the System Setup - Configuration screen, the defibrillator automatically turns to the asynchronous defibrillation mode.
NOTE
Select the appropriate energy and appropriate size of the internal paddles according to the patient. Only use the paddles specified by Nihon Kohden. Cardioversion is not available when any Setup screen or System Setup screen is displayed. Before using the defibrillator, confirm and set the necessary settings on the Setup screen and System SetupConfiguration screen. Synchronized cardioversion should be performed with the minimum effective energy. It is reported that the cardiac muscle may necrose if high energy is repeatedly applied to the heart with internal paddles. Refer to Reference in Section 11.
Procedure
1. Connect the internal paddles to the defibrillator. 1) Press the paddle release knob of the paddle connector to the right and remove the external paddles from the paddle connector.
4.2.18
4. DEFIBRILLATION, SYNCHRONIZED CARDIOVERSION and AED 2) Connect the internal paddles to the paddle connector until it clicks.
CAUTION
2. Turn the Energy/Mode Select control to the DISARM position to turn the power on. Confirm that there is no error message on the screen. For error messages, refer to Section 9. When operating with AC power, confirm that the AC lamp is on. 3. Prepare the patient to monitor the ECG waveforms. When monitoring ECG waveform with the ECG connection cable and disposable electrodes, 1) Connect the ECG connection cable to the ECG input connector on the front panel. 2) Attach the disposable electrodes to the patient. Refer to Section 4 Preparing for ECG Monitoring. 3) Clip the ECG connection cable to the electrode. Confirm that electrodes are not pulled by the ECG connection cable.
To acquire ECG waveform from another monitor, refer to Using the ECG Waveforms from Another Monitor, Paddles or Disposable Pads for Synchronized Cardioversion in this section. 4. Press the ECG lead key to select the lead which has the highest QRS wave. When acquiring a synchronizing signal with the ECG connection cable and disposable electrodes, usually II is selected. When using the ECG waveform from another monitor, select AUX.
4.2.19
WARNING
Never select TEST for the ECG lead. TEST is for maintenance and the waveform displayed on the screen is not the patients ECG. If synchronized cardioversion is performed with the TEST lead, the discharge is not synchronized with the patients QRS and it may cause ventricular fibrillation.
NOTE
NOTE
When the Energy/Mode Select control is set to MONITOR, AED, DEMAND or FIXED position, the SYNC mode cannot be selected. If the Energy/Mode Select control is set to MONITOR, AED, DEMAND or FIXED position while the SYNC mode is selected (SYNC lamp is lit), the defibrillator exits the SYNC mode.
4.2.20
4. DEFIBRILLATION, SYNCHRONIZED CARDIOVERSION and AED 6. Position the internal paddles Position the sterilized internal paddles against the right and the left atria of the heart.
NOTE
It is not necessary to consider the polarities of the internal paddle electrodes. For better contact between the internal paddles and heart, place sterilized gauze moistened with physiological saline solution between each internal paddle and the heart.
7. Select the energy level Turn the Energy/Mode Select control to the desired energy position. When the internal paddles are used, 50 J or below can be selected. If above 50 J is selected, the Set energy to 50 J or less message appears on the screen and the selected energy cannot be charged. 8. Charge the energy When it is verified that the patient needs synchronized cardioversion, press the CHARGE/AED button on the front panel to start charging.
WARNING
During charging and discharging, grip the internal paddles between the guard at the top of the handle and the cable. If you grip the handle between the electrode and the guard, you may get an electrical shock. Do not carry or move the defibrillator with the charged energy remaining in the defibrillator. If the defibrillator falls down, it discharges energy and can cause electrical shock. guard
4.2.21
To change the energy level after charging is completed Turn the Energy/Mode Select control to the desired energy position. The defibrillator starts adjusting the energy one second after the new energy is selected.
NOTE
If above 50 J is selected, the defibrillator immediately discharges energy internally. When cardioversion becomes unnecessary after charging is completed Turn the Energy/Mode Select control to the DISARM position or OFF position. The defibrillator internally discharges charged energy within 20 seconds. The defibrillator automatically internally discharges charged energy when the charge holding time has passed. This time is selected on the System Setup Configuration screen. 9. Discharge the energy to the patient After confirming that the DISCHARGE lamp blinks and SYNC lamp lights, press the DISCHARGE button on the front panel to discharge the energy to the patient. Hold the buttons until energy is discharged. Firmly hold the handles of the internal paddles until energy is discharged.
4.2.22
WARNING
Make sure that no one is in contact with either the patient or any equipment which supports or is connected to the patient. Before discharging, confirm that the paddles are firmly positioned against the heart. Failure to follow this warning causes serious skin burn or poor energy discharge to the heart. Do not discharge near a person or object other than the patient or test electrode plate or energy checker. This may cause electrical shock to the person or object. Do not discharge with the paddles in the air. This may cause electrical shock to the operator or damage the defibrillator.
CAUTION
10. If another cardioversion is required, perform necessary medical treatment and repeat steps 5 to 9. 11. Turn the power off Turn the Energy/Mode Select control to the OFF position.
NOTE
While the Shutdown NOW message is displayed on the screen, do not disconnect the power cord from the defibrillator or AC outlet and do not remove the battery pack from the defibrillator. Otherwise, the internal data may be damaged. Press the paddle release knob of the paddle connector to the right and remove the internal paddles from the paddle connector. Hold the connector part to disconnect the paddle connector. Otherwise the connector gets damaged and the cable breaks. Wash off blood from the internal paddles and sterilize them. Refer to Cleaning, Disinfecting and Sterilization in Section 10.
4.2.23
4.2.24
AED
AED Screen ..................................................................................................................... 4.3.1 Important Safety Information ........................................................................................... 4.3.2 AED Flowchart ................................................................................................................. 4.3.4 Preparation for AED Mode ...................................................................................... 4.3.5 AED Procedure ................................................................................................................ 4.3.6 When Nonshockable Rhythm Is Detected In AED Analysis ................................. 4.3.15
4.3C.1
4.3C.2
AED Screen
In AED mode, the defibrillator analyzes the ECG waveforms (AED analysis). When shockable waveform (Ventricular Fibrillation and Ventricular tachycardia) is detected, the defibrillator automatically charges the preset energy.
Screen Example
1st charge energy (currently selected energy is highlighted.) Alarm off mark ECG lead Heart rate 2nd charge energy 3rd charge energy AC power operation
Sensitivity ECG
AED mode Charged energy
Pause key
When AED mode is selected, the Multifunction key changes to the Pause key to temporarily stop AED analysis.
4.3.1
WARNING
Before defibrillation, make sure that no one is in contact with either the patient or any metal part of any equipment or cables which supports or is connected to the patient. Failure to follow this warning causes serious electrical shock or injury. When using an ESU, use this defibrillator only in the MONITOR mode and use the ECG electrodes for monitoring. Do not monitor ECG with disposable pads, external paddles or internal paddles. If ECG is monitored with pads or paddles, high frequency energy from the ESU causes abnormal current to flow in the patient and unexpected discharge. This may damage the defibrillator. Use the ECG monitoring electrodes (disposable electrodes) to monitor the ECG waveforms. Stable ECG cannot be acquired with the PADDLE lead because it is difficult to hold the paddles stable. ECG acquired from external paddles, internal paddles or disposable pads is unstable after discharge because of high polarization voltage. Confirm that there is no noise on the ECG. Noise may be misrecognized as QRS and discharge might not synchronize with the patients QRS. The defibrillator must only be operated by trained and qualified medical personnel. Failure to follow the warnings below may cause skin burn or insufficient energy discharge and insufficient pacing current to the heart. - Do not reuse disposable pads. - If the pad package is torn, dispose of the pads and do not use them. - Do not use the pads if they are past the expiration date on the package. - Use the disposable pads as soon as possible after opening the package. - Do not use the disposable pads if the gel has become dry or if the gel has become abnormal (the gel has become liquid or is coming off the edges of the pad, etc). - Do not use the disposable pads if the gel is dark brown or dark brown gel is on the protective sheet. If any pad or connector gets wet, replace it with a new one. If a wet pad or connector is used, it may cause electrical shock.
4.3.2
CAUTION
NOTE
AED mode can be used for patients 8 years or older or 25 kg or more. Follow all disposable pad labeling instructions. Always prepare the second set of disposable pads before defibrillation. Use the second set of disposable pads if the gel of the first set of disposable pads is dry, deteriorated or changes color. Before attaching the disposable pads to the patient, clean the skin where the pads will be attached. If the skin is moist, use a cotton swab to dry it. Defibrillation is not available when any Setup screen or System Setup screen is displayed. Before using the defibrillator, confirm and set the necessary settings on the Setup screen and System SetupConfiguration screen.
4.3.3
AED Flowchart
Turn Energy/Mode Select control to AED
AED button First Analysis
OFF
User operation Instrument operation
ON
AED
Press CHARGE/AED button.
Bold: Displayed message
Press CHARGE/AED button VF analysis starts

Analyzing VF Stand clear
Italic: Settings in System Setup screen
nonshockable rhythm Result? shockable rhythm

Defibrillation necessary. Check ECG. Defibrillation not necessary. Check ECG.
Charging starts
CHARGING
CPR
Check pulse **
Charging finishes
CHARGED Stand clear and press DISCHARGE buttons.
When set to OFF *
CPR time(s)
When set to any number
Press DISCHARGE button

If no pulse, start CPR. **
Yes End sequence? No Each Seq. or OFF

AED button 2nd or later Analysis
(start analysis manually?)
CPR timing sound generates
End after selected time
Each shock
OFF
AED button 2nd or later Analysis

(start analysis manually?)
Each shock or Each Seq.

If no pulse, press AED button. **
* If defibrillation becomes necessary during CPR, press the CHARGE/AED button. Analysis immediately starts and operation proceeds from the VF analysis starts step in the flowchart. ** Check pulse, If no pulse, start CPR and If no pulse, press AED button messages are not displayed when the Check Pulse Pattern on the System Setup screen is set to 3 (no checking pulse). 4.3.4 Operator's Manual TEC-5500
Preparation for AED Mode
Change the following settings, if necessary. Refer to System Setup Screen in Section 3. The factory default settings are underlined. AED AED Energy ( 2 to 100, 150, 200, 270 J) The first, second and third energy in each discharge/AED sequence. When a shockable waveform is detected, the selected energy is automatically charged. The number of discharges for one sequence is set in Discharge/AED sequence. Energy after 3rd discharge (Repeat cycle, 3rd energy) The energy after the third discharge. AED button First Analysis (ON, OFF) When AED mode is selected, select or not to start AED analysis (shockable waveform detection) by pressing the CHARGE/ED button. If ON (default setting) is selected, you must press the CHARGE/AED button to start AED analysis. AED button 2nd or later Analysis (Each shock, Each Seq., OFF) Select whether to manually or automatically start AED analysis after each discharge or each sequence. Select OFF to automatically start AED analysis. If Each shock or Each Seq. is selected, you must press the CHARGE/AED button to start AED analysis. Discharge/AED sequence (2, 3, 4) The number of discharges for one sequence. Pause time (30, 60, 120, 180 seconds and OFF) In AED mode, the Multi-function key changes to the Pause key. Background AED analysis can be temporarily paused by pressing the PAUSE key. CPR CPR time (s) (30, 60, 90, 120, 150, 180, 210 seconds, OFF) The time until starting AED analysis in background after a discharge/AED sequence. CPR timing sound (60, 70, 80, 90, 100, 110, 120 seconds, OFF) Duration of CPR timing sound.
4.3.5
AED Procedure
1. Confirm that the patient is unconscious and has no respiration and no pulse.
CAUTION
Before AED analysis or defibrillation, confirm that the patient is unconscious and has no respiration and no pulse. The ECG of a child or a patient with an implanted pacemaker cannot be analyzed correctly. For these patients, follow the physicians instruction.
CAUTION
3. Turn the Energy/Mode Select control to the AED position to turn the power on. Confirm that there is no error message on the screen. For error messages, refer to Section 9. When operating with AC power, confirm that the AC lamp is on. When AED mode is selected, the Multi-function key changes to the Pause key. To temporarily pause background AED analysis, press the Pause key. The pause time is set on the System Setup - Configuration screen. When the Pause key is pressed, it changes to the Resume key. To start AED analysis, press the Resume key. 4.3.6 Operator's Manual TEC-5500
4. DEFIBRILLATION, SYNCHRONIZED CARDIOVERSION and AED 4. Confirm that PADDLE is selected for ECG lead.
NOTE
In AED mode, other ECG leads cannot be selected. 5. Prepare the disposable pads. 1) To allow firm pad contact with the skin, clean the patients chest to remove oil, moisture and dirt, and thoroughly dry the skin. Clip excessive hair, if necessary.
NOTE
3) Attach the pads to the patients body, one at a time. Apex-Anterior placement RA: Right side of sternum and below the clavicle LL: On the level of fifth intercostal space and midaxillary line
WARNING
4.3.7
CAUTION
NOTE
When the skin-pad contact is poor, it causes high electrode impedance and energy cannot be charged. 4) Connect the disposable pads to the pad adaptor.
NOTE
Firmly connect the disposable pads to the pad adaptor until the connector of the disposable pads clicks. If the pads are not attached firmly or the pads are not connected to the pad adaptor, noise appears on the ECG waveform. When the Change disposable pads message appears, the pads may be faulty. Replace them with new ones. If the message still appears, stop using the defibrillator and use a different defibrillator.
6. Confirm the selected energy values Three selected energy values are displayed on the upper screen. The 1st energy is selected. The selected energy is highlighted. Confirm that the energy is proper. To change the energy values, use the AED Energy setting in the System Setup - Configuration screen. Refer to Section 3. The following waveforms are saved in memory. - Waveform of 10 seconds before and 12 seconds after discharge - Waveform of 6 seconds after the CHARGE/AED button is pressed. If you want to record any other waveform, press the Record key and print the waveform on the recording paper. Waveform of 6 seconds after the CHARGE/ AED button is pressed can be printed as a report. For details refer to Section 8.
4.3.8
4. DEFIBRILLATION, SYNCHRONIZED CARDIOVERSION and AED 7. Start AED analysis. Stop the life saving treatment such as CPR, keep the patient at rest and do not touch or move the patient, pad adaptor and disposable pad cable. Then press the CHARGE/AED button on the front panel. The background AED analysis starts and the Stand clear message appears on the screen. To automatically start background AED analysis, set AED button First Analysis in the System Setup - Configuration screen to OFF. selected energy
WARNING
When you perform defibrillation in an ambulance, stop the car.
CAUTION
During AED analysis, stop life saving treatment such as CPR. Do not touch or move the patient, pad adapter and disposable pad cable. Correct analysis result cannot be obtained.
NOTE
If a shockable rhythm is detected after the CHARGE/AED button is pressed, the defibrillator automatically starts charging the selected (highlighted) energy. Therefore, take much care for handling the CHARGE/AED button. Waveforms of 6 seconds after the CHARGE/AED button is pressed and the analysis result can be recorded as VF Analysis report recording. Up to 124 waveforms can be saved in memory. The oldest 31 waveforms are deleted when you save over 124 waveforms. For details refer to Section 8.
4.3.9
4. DEFIBRILLATION, SYNCHRONIZED CARDIOVERSION and AED 8. CHARGING message appearance When a shockable rhythm is detected, the Defibrillation necessary. Check ECG and CHARGING messages appear on the screen, there is a continuous beeping sound. The defibrillator automatically charges the selected energy (highlighted energy on the screen).
WARNING
NOTE
Asystole is not judged to be a shockable rhythm and the defibrillator does not automatically charge the energy. If the amplitude of a waveform is very small, the waveform may not be judged as a shockable rhythm and automatic energy charging may not be performed. Automatic energy charging criteria is: - Ventricular fibrillation with average amplitude not less than 0.1 mV, or - Ventricular tachycardia with pulse rate not less than 180/min When small amplitude ventricular fibrillation is not judged to be shockable rhythm, follow the physicians instruction and continue the appropriate treatment. By continuing CPR, the amplitude of ventricular fibrillation may become large and reanalysis may start automatic energy charging. Pay attention to the change in ECG after automatic energy charging starts. If the CHARGE/AED button is pressed when a disposable pad is detached from the patient, charging does not start. If a disposable pad is detached during or after charging, the defibrillator automatically discharges energy internally within 20 seconds.
4.3.10
4. DEFIBRILLATION, SYNCHRONIZED CARDIOVERSION and AED 9. CHARGED message appearance When charging is completed, there is a continuous buzzing sound, the Stand clear and press DISCHARGE button and CHARGED messages appear on the screen, and the DISCHARGE lamp blinks.
When defibrillation becomes unnecessary after charging is completed To quit defibrillation, turn the Energy/Mode Select control to the DISARM position or OFF position to internally discharge the charged energy. After charging is complete, if nonshockable rhythm is detected, the defibrillator automatically discharges the charged energy internally. For the nonshockable rhythm, refer to When Nonshockable Rhythm Is Detected In AED Analysis in this section. The time until internal discharge is set at Charge holding time on the System Setup - Configuration screen.
WARNING
4.3.11
4. DEFIBRILLATION, SYNCHRONIZED CARDIOVERSION and AED 10. Discharge the energy to the patient Confirm that the DISCHARGE lamp blinks. Then press the DISCHARGE button on the front panel to discharge the energy to the patient.
WARNING
Before defibrillation, make sure that no one is in contact with either the patient or any metal part of any equipment or cables which supports or is connected to the patient. Failure to follow this warning causes serious electrical shock or injury. Before defibrillation, remove from the patient all electrodes, probes and transducers from a connector that do not have a or mark. Otherwise, the operator may receive electrical shock and the connected instrument may be damaged. Before defibrillation, remove everything (electrodes, patches, etc.) from the patients chest. When the defibrillator paddle directly contacts these materials, the discharged energy may cause skin burn to the patient. Before defibrillation, check that the cords and cables of the electrodes, probes and transducers attached to the patient are properly connected to a connector that has a or mark. Touching the metal parts of the disconnected cords and cables may cause electrical shock or injury by discharged energy. Do not perform defibrillation in a wet place. Before defibrillation, move the patient and defibrillator to a dry place. Otherwise the operator may get electrical shock. Never discharge near a person or object other than the patient or test electrode plate or energy checker. It may cause electrical shock to the person or damage the object. Before discharging, confirm that the pads are firmly applied to the chest wall. Failure to follow this warning causes skin burn or poor energy discharge to the heart. During charging or discharging, do not touch the pads or connectors. Failure to follow this warning causes electrical shock to the operator. Do not discharge if the pads overlap each other or are shorted to each other by anything conductive such as contact gel. This may cause skin burn and poor energy discharge to the heart.
NOTE
Firmly press the DISCHARGE button. After defibrillation, the defibrillator returns to the condition of before AED analysis starts. The selected energy switches to the next energy. The next energy is highlighted on the upper screen.
4.3.12
4. DEFIBRILLATION, SYNCHRONIZED CARDIOVERSION and AED 11. Start AED analysis for the second discharge. The defibrillator automatically starts reanalysis (when AED button 2nd or later analysis is set to Each Seq. (default setting) or OFF on the System Setup - Configuration screen). When the analysis result is shockable rhythm, the defibrillator starts charging the 2nd energy. Follow steps 8 to 10 and discharge the energy to the patient. When the analysis result is nonshockable rhythm, refer to When Nonshockable Rhythm Is Detected In AED Analysis in this section. 12. Start AED analysis for the third discharge. The defibrillator automatically starts reanalysis (when AED button 2nd or later analysis is set to Each Seq. (default setting) or OFF on the System Setup - Configuration screen). When the analysis result is shockable rhythm, the defibrillator starts charging the 3rd energy. Follow steps 8 to 10 and discharge the energy to the patient. When the analysis result is nonshockable rhythm, refer to When Nonshockable Rhythm Is Detected In AED Analysis in this section. 13. After three sets of analysis (when Discharge/AED sequence (number of discharges for one sequence) is set to 3 (default setting) on the System Setup - Configuration screen), charging and defibrillation are performed and the defibrillation failed, do necessary treatments such as CPR. The CPR timing sound occurs according to the setting value at the CPR timing sound on the System Setup - Configuration screen. During CPR, to temporarily pause background AED analysis, press the Pause key. When the Pause key is pressed, it changes to the Resume key. To start backgrond AED analysis, press the Resume key. The CPR timing sound stops.
NOTE
When defibrillation becomes necessary during CPR, press the CHARGE/ AED button to immediately start analysis. 14. If the patient needs defibrillation after CPR, repeat the steps from 7. On the System Setup - Configuration screen, you can select two types of energy selection after the 3rd defibrillation. Refer to Section 3.
4.3.13
4. DEFIBRILLATION, SYNCHRONIZED CARDIOVERSION and AED 15. Turn the power off Turn the Energy/Mode Select control to the OFF position.
NOTE
4.3.14
When Nonshockable Rhythm Is Detected In AED Analysis
In AED analysis, nonshockable rhythm is detected in the following cases. Asystole Ventricular fibrillation with average amplitude less than 0.1 mV Ventricular tachycardia with pulse rate less than 180/min With the above analysis result, energy is not charged automatically. Perform appropriate treatment according to emergency life saving protocol. If the patient condition changes, perform AED analysis again and follow the physicians instruction.
NOTE
If the amplitude of a waveform is very small, the waveform may not be judged as a shockable rhythm and automatic energy charging may not be performed. Automatic energy charging standard is: - Ventricular fibrillation with average amplitude not less than 0.1 mV, or - Ventricular tachycardia with pulse rate not less than 180/min When small amplitude ventricular fibrillation is not judged to be a shockable rhythm, follow the physicians instruction and continue the appropriate treatment. By continuing CPR, the amplitude of ventricular fibrillation may become large and reanalysis may start automatic energy charging.
4.3.15
4.3.16
Section 5 Pacing
About Pacing ....................................................................................................................... 5.1 Important Safety Information ................................................................................................ 5.2 Pacing in FIXED mode ......................................................................................................... 5.3 Information on the Pacing Screen in FIXED Mode ..................................................... 5.3 Procedure .................................................................................................................. 5.4 Pacing in DEMAND mode ................................................................................................. 5.11 Information on the Pacing Screen in DEMAND Mode .............................................. 5.11 Procedure ................................................................................................................ 5.12
5C.1
5C.2
5. PACING (TEC-5531 Series Only)
About Pacing
Noninvasive fixed and demand pacing is only available with TEC-5531 series defibrillators. After defibrillation, if bradycardia is observed, immediate electric stimulation can be given through the patients chest with the disposable pads. The ECG waveforms during pacing can be monitored continuously with the ECG connection cable and disposable electrodes. Two pacing modes are provided with the TEC-5531 series defibrillators. FIXED mode: Pacing current is output at the selected pacing rate. DEMAND mode: When there is no spontaneous heart beat, pacing current is output at the selected pacing rate. When there is a spontaneous heart beat and the next heart beat does not occur, pacing current is output at the selected pacing rate.
5.1
WARNING
Do not perform pacing while using an ESU. Before using the ESU, turn the defibrillator power off and remove disposable pads from the patient. Otherwise, high frequency energy from the ESU causes abnormal current to flow into the patient and causes electrical burn, shock or other injury. It also damages the defibrillator. Always monitor the ECG waveform with the ECG connection cable and ECG electrodes. The defibrillator must only be operated by trained and qualified medical personnel. Confirm that there is no noise on the ECG. Noise may be misrecognized as QRS and discharge might not synchronize with the patients QRS. Failure to follow the warnings below may cause skin burn or insufficient energy discharge and insufficient pacing current to the heart. - Do not reuse disposable pads. - If the pad package is torn, dispose of the pads and do not use them. - Do not use the pads if they are past the expiration date on the package. - Use the disposable pads as soon as possible after opening the package. - Do not use the disposable pads if the gel has become dry or if the gel has become abnormal (the gel has become liquid or is coming off the edges of the pad, etc). - Do not use the disposable pads if the gel is dark brown or dark brown gel is on the protective sheet. If any pad or connector gets wet, replace it with a new one. If a wet pad or connector is used, it may cause electrical shock. When using the disposable pads for long term pacing, replace them every hour. Failure to follow this warning may cause skin burn or insufficient energy discharge and pacing current to the heart.
CAUTION
When using the disposable pads for long term ECG monitoring, replace them every 24 hours. Failure to follow this instruction may cause insufficient pacing current and insufficient energy discharge to the heart. Check that the pacing pulse is effective by observing ECG on the screen. Do not attach a disposable pad over another pad. It may cause skin burn on the patient. Do not put heavy objects on the disposable pads or bend the pads. If the pads get damaged or deteriorated, it may cause skin burn on the patient.
NOTE
Follow all disposable pad labeling instructions. 5.2 Operator's Manual TEC-5500
Pacing in FIXED mode

Information on the Pacing Screen in FIXED Mode
The following information can be displayed on the pacing screen in FIXED mode.
Heart rate
ECG lead QRS sync mark
AC power operation
ECG sensitivity
ECG waveform Pacing pulse output point Fixed pacing mode pacing current Pacing rate
This is the pacing screen in FIXED mode which appears when neither SpO2 nor CO2 are monitored.
5.3
Procedure
CAUTION
2. Turn the Energy/Mode Select control to the FIXED position to turn the power on. Confirm that the Fixed message appears and there is no error message on the screen and. For error messages, refer to Section 9. 3. Prepare the patient to monitor the ECG waveforms with the defibrillator. 1) Connect the ECG connection cable to the ECG input connector on the front panel. 2) Attach the disposable ECG monitoring electrodes to the patient. Refer to Section 6 Preparing for ECG Monitoring.
NOTE
Do not attach the ECG monitoring electrodes where the disposable pads will be attached. If the disposable pads and ECG monitoring electrodes are placed near each other, noise by pacing pulse becomes large and ECG cannot be observed. If the noise is large, change the ECG electrode position and ECG lead. 3) Clip the ECG connection cable to the electrode. Confirm that electrodes are not pulled by the ECG connection cable. 5.4 Operator's Manual TEC-5500
5. PACING (TEC-5531 Series Only) 4. Press the ECG lead key to select the lead which has the highest QRS wave. Usually II is selected.
WARNING
Never select TEST for the ECG lead. TEST is for maintenance and the waveform displayed on the screen is not the patients ECG. If synchronized cardioversion is performed with the TEST lead, the discharge is not synchronized with the patients QRS.
NOTE
Select a lead so that the whole waveform is displayed on the screen and the T waveform is not much higher than the QRS waveform. Otherwise, QRS cannot be recognized correctly. If the defibrillator miscounts the narrow width QRS, set Pacing Pulse Reject to OFF on the ECG Setup screen and confirm that QRS is correctly recognized. 5. Select the pacing rate with the PACING RATE Up/Down key. The selected rate appears at the lower right corner of the screen.
WARNING
The pacing rate must be determined by qualified medical personnel based on the heart rate of the patient in a normal state.
6. Select 0 mA with the PACING OUTPUT Up/Down key. Confirm that the FIXED mode is selected. 7. Prepare the disposable pads.
WARNING
Failure to follow the warnings below may cause skin burn or insufficient energy discharge and insufficient pacing current to the heart. - Do not reuse disposable pads. - If the pad package is torn, dispose of the pads and do not use them. - Do not use the pads if they are past the expiration date on the package. - Use the disposable pads as soon as possible after opening the package. - Do not use the disposable pads if the gel has become dry or if the gel has become abnormal (the gel has become liquid or is coming off the edges of the pad, etc). - Do not use the disposable pads if the gel is dark brown or dark brown gel is on the protective sheet.
5.5
5. PACING (TEC-5531 Series Only) WARNING - continued If any pad or connector gets wet, replace it with a new one. If a wet pad or connector is used, it may cause electrical shock. When using the disposable pads for long term pacing, replace them every hour. Failure to follow this warning may cause skin burn or insufficient energy discharge and pacing current to the heart.
CAUTION
NOTE
Always prepare the second set of disposable pads before pacing. Use the second set of disposable pads if the gel of the first set of disposable pads is dry, deteriorated or changes color. Before attaching the disposable pads to the patient, clean the skin where the pads will be attached. If the skin is moist, use a cotton swab to dry it. 1) To allow firm pad contact with the skin, clean the patients chest to remove oil and dirt, and thoroughly dry the skin. Clip excessive hair, if necessary.
NOTE
5.6
5. PACING (TEC-5531 Series Only) 3) Attach the pads to the patients body, one at a time.
WARNING
Failure to follow the following warnings causes serious skin burn. Do not attach the pads over ECG electrode. Do not attach pads on the papilla or medicine on the patients body. Fit the pad closely to the body surface so that current flows uniformly through the pad. This reduces the required pacing current and pain and discomfort to the patient.
CAUTION
Anterior-Apex placement RA: Right side of sternum and below the clavicle LL: On the level of fifth intercostal space and midaxillary line
5.7
5. PACING (TEC-5531 Series Only) Apex-Posterior placement RA: Between right scapula and spine LL: On the level of fifth intercostal space and midaxillary line
WARNING
The apex-posterior placement is not suitable for ECG monitoring or AED analysis.
Anterior-Posterior placement RA: Between left scapula and spine LL: Fifth middle axial line
WARNING
The anterior-posterior placement is not suitable for ECG monitoring or AED analysis. Use this placement only for pacing.
5.8
5. PACING (TEC-5531 Series Only) 4) Connect the disposable pads to the pad adaptor.
NOTE
Firmly connect the disposable pads to the pad adaptor until the connector of the disposable pads clicks. When the Change disposable pads message appears, the pads may be faulty. Replace them with new ones. If the message still appears, stop using the defibrillator and use a different defibrillator.
8. Press the START/STOP key to start pacing. The Now Pacing message appears. 9. Gradually increase the pacing current with the PACING OUTPUT Up/Down key. The pacing current appears at the lower right corner of the screen. When a pacing pulse is output, the PULSE lamp lights and a mark appears below the ECG waveforms.
WARNING
Do not touch the patient, pads or connectors during pacing. It may cause electrical shock. During charging or discharging, do not touch the pads or connectors. Failure to follow this warning causes electrical shock to the operator. The pacing current must only be increased by qualified medical personnel decision. Keep the current intensity as low as possible to minimize pain and discomfort to the patient.
CAUTION
Check that the pacing pulse is effective by observing ECG on the screen.
5.9
NOTE
When the pacing intensity is set to 0 mA, the PULSE lamp does not light. Pacing is not performed for 3 seconds after the START/STOP key is pressed. When the pacing intensity is set to under 10 mA, the Pacing stopped. (paddle disconnected) message may not be displayed. Always check the pacing effect on the screen. To stop pacing, press the START/STOP key or select 0 mA with the PACING OUTPUT Up/Down key.
NOTE
When you stop pacing by selecting 0 mA with the PACING OUTPUT Up/ Down key, pacing restarts when you select another intensity with the PACING OUTPUT Up/Down key. 10. Turn the Energy/Mode Select control to the OFF position. Press the paddle release knob of the paddle connector on the front panel and remove the pad adaptor from the paddle connector. Dispose of the disposable pads and the electrodes too.
NOTE
While the Shutdown NOW message is displayed on the screen, do not disconnect the power cord from the defibrillator or AC outlet and do not remove the battery pack from the defibrillator. Otherwise, the internal data may be damaged.
5.10
Pacing in DEMAND mode

Information on the Pacing Screen in DEMAND Mode
The following information can be displayed on the pacing screen in DEMAND mode. ECG lead Heart rate ECG sensitivity QRS wave detection point QRS sync mark Spontaneous ECG AC power operation
Demand pacing mode Pacing pulse output point Pacing current Pacing rate
This is the pacing screen in DEMAND mode which appears when neither SpO2 nor CO2 is monitored.
5.11
Procedure WARNING
Confirm that there is no noise on the ECG. Noise may be misrecognized as QRS and discharge might not synchronize with the patients QRS.
1. Connect the pad adaptor to the defibrillator. 1) Press the paddle release knob of the paddle connector on the right panel and remove the external paddles from the paddle connector.
CAUTION
2. Turn the Energy/Mode Select control to the DEMAND position to turn the power on. Confirm that the Demand appears and that there is no error message on the screen. For error messages, refer to Section 9.
3. Prepare the patient to monitor the ECG waveforms with the defibrillator. 1) Connect the ECG connection cable to the ECG input connector on the front panel. 2) Attach the disposable ECG monitoring electrodes to the patient. Refer to Section 6 Preparing for ECG Monitoring. 5.12 Operator's Manual TEC-5500
NOTE
Do not attach the ECG monitoring electrodes where the disposable pads will be attached. If the disposable pads and ECG monitoring electrodes are placed near each other, noise from the pacing pulse becomes large and ECG cannot be observed. If the noise is large, change the ECG electrode position and ECG lead. 3) Clip the ECG connection cable to the electrode. Confirm that electrodes are not pulled by the ECG connection cable.
4. Press the ECG lead key to select the lead which has the highest QRS wave. Usually II is selected.
WARNING
Never select TEST for the ECG lead. TEST is for maintenance and the waveform displayed on the screen is not the patients ECG. If synchronized cardioversion is performed with the TEST lead, the discharge is not synchronized with the patients QRS.
NOTE
Select a lead so that the whole waveform is displayed on the screen and the T waveform is not much higher than the QRS waveform. Otherwise, QRS cannot be recognized correctly. If the defibrillator miscounts the narrow width QRS, set Pacing Pulse Reject to OFF on the ECG Setup screen and confirm that QRS is correctly recognized. 5. Select the pacing rate with the PACING RATE Up/Down key. The selected rate appears in the lower right corner of the screen.
WARNING
The pacing rate must be determined by qualified medical personnel based on the heart rate of the patient in a normal state.
6. Select 0 mA with the PACING OUTPUT Up/Down key. Confirm that DEMAND mode is selected.
5.13
5. PACING (TEC-5531 Series Only) 7. Prepare the disposable pads.
WARNING
Failure to follow the warnings below may cause skin burn or insufficient energy discharge and insufficient pacing current to the heart. - Do not reuse disposable pads. - If the pad package is torn, dispose of the pads and do not use them. - Do not use the pads if they are past the expiration date on the package. - Use the disposable pads as soon as possible after opening the package. - Do not use the disposable pads if the gel has become dry or if the gel has become abnormal (the gel has become liquid or is coming off the edges of the pad, etc). - Do not use the disposable pads if the gel is dark brown or dark brown gel is on the protective sheet. If any pad or connector gets wet, replace it with a new one. If a wet pad or connector is used, it may cause electrical shock. When using the disposable pads for long term pacing, replace them every hour. Failure to follow this warning may cause skin burn or insufficient energy discharge and pacing current to the heart.
CAUTION
NOTE
Always prepare the second set of disposable pads before pacing. Use the second set of disposable pads if the gel of the first set of disposable pads is dry, deteriorated or changes color. Before attaching the disposable pads to the patient, clean the skin where the pads will be attached. If the skin is moist, use a cotton swab to dry it. 1) To allow firm pad contact with the skin, clean the patients chest to remove oil and dirt, and thoroughly dry the skin. Clip excessive hair, if necessary. 5.14 Operator's Manual TEC-5500
NOTE
3) Attach the pads to the patients body, one at a time.
WARNING
Failure to follow the following warnings causes serious skin burn. Do not attach the pads over ECG electrode. Do not attach pads on the papilla or medicine on the patients body. Fit the pad closely to the body surface so that current flows uniformly through the pad. This reduces the required pacing current and pain and discomfort to the patient.
CAUTION
Anterior-Apex placement RA: Right side of sternum and below the clavicle LL: On the level of fifth intercostal space and midaxillary line
5.15
5. PACING (TEC-5531 Series Only) Apex-Posterior placement RA: Between right scapula and spine LL: On the level of fifth intercostal space and midaxillary line
WARNING
The apex-posterior placement is not suitable for ECG monitoring or AED analysis.
Anterior-Posterior placement RA: Between left scapula and spine LL: Fifth middle axial line
WARNING
The anterior-posterior placement is not suitable for ECG monitoring or AED analysis. Use this placement only for pacing.
5.16
5. PACING (TEC-5531 Series Only) 4) Connect the disposable pads to the pad adaptor.
NOTE
Firmly connect the disposable pads to the pad adaptor until the connector of the disposable pads clicks. When the Change disposable pads message appears, the pads may be faulty. Replace them with new ones. If the message still appears, stop using the defibrillator and use a different defibrillator. 8. Check that the mark appears on every QRS wave. The mark indicates that the defibrillator detects the QRS wave. If the mark does not appear: - Change the amplitude of the ECG waveforms with the ECG sensitivity key. - Change the ECG lead with the ECG lead key. - Change the electrode position.
9. Press the START/STOP key to start pacing. The Now Pacing message appears.
10. Gradually increase the pacing current with the PACING OUTPUT Up/Down key until QRS by pacing appears on the screen. The pacing current appears in the lower right corner of the screen. When a pacing pulse is output, the PULSE lamp lights and a mark appears below the ECG waveforms.
WARNING
Do not touch the patient during pacing. Failure to follow this warning may cause electrical shock. During charging or discharging, do not touch the pads or connectors. Failure to follow this warning causes electrical shock to the operator. Do not change the sensitivity or ECG lead setting after pacing is started. If one of these settings is changed, the pacing stops for 3 seconds. Failure to follow this warning may cause serious heart attack. The pacing current must only be increased by qualified medical personnel decision.
5.17
WARNING continued
Keep the current intensity as low as possible to minimize pain and discomfort to the patient. No QRS wave is detected: - For 240 ms after the pacing pulse is output, if the pacing rate is set to 100 ppm or more. - For 350 ms after the pacing pulse is output, if the pacing rate is set to 90 ppm or less.
CAUTION
Check that the pacing pulse is effective by observing ECG on the screen.
NOTE
The paced QRS wave may not be counted correctly. When the pacing intensity is set to 0 mA, the PULSE lamp does not light. Pacing is not performed for 3 seconds after the START/STOP key is pressed. When the pacing intensity is set to under 10 mA, the Pacing stopped. (paddle disconnected) message may not be displayed. Always check the pacing effect on the screen. To stop pacing, press the START/STOP key or select 0 mA with the PACING OUTPUT Up/Down key.
NOTE
When you stop pacing by selecting 0 mA with the PACING OUTPUT Up/ Down key, pacing restarts when you select another intensity with the PACING OUTPUT Up/Down key. 11. Turn the Energy/Mode Select control to the OFF position. Press the paddle release knob of the paddle connector on the front panel and remove the pad adaptor from the paddle connector. Dispose of the disposable pads and the electrodes.
NOTE
While the Shutdown NOW message is displayed on the screen, do not disconnect the power cord from the defibrillator or AC outlet and do not remove the battery pack from the defibrillator. Otherwise, the internal data may be damaged.
5.18
Section 6 Monitoring
General ............................................................................................................................. 6.0.1 Displaying the Monitoring Screen ........................................................................... 6.0.1 Screen Examples ................................................................................................... 6.0.1 ECG Monitoring Preparing for ECG Monitoring ........................................................................................... 6.1.2 Preparation Flowchart ............................................................................................ 6.1.2 Selecting a Lead .................................................................................................... 6.1.2 Number of Electrodes and Measuring Leads .......................................................... 6.1.3 Electrode Position .................................................................................................. 6.1.3 3 Electrode Leads ........................................................................................ 6.1.3 5 Electrode Leads ........................................................................................ 6.1.4 Selecting Electrodes and Lead ............................................................................... 6.1.5 Types of Electrodes and Lead ...................................................................... 6.1.5 Connecting the ECG Connection Cable or the JC-762V/JC763V Connection Cable to the Defibrillator ....................................................................................................... 6.1.6 Connecting the ECG Connection Cable to the Defibrillator ........................... 6.1.6 Connecting the JC-762V/JC763V Connection Cable to the Defibrillator ....... 6.1.6 Attaching Disposable ECG Electrodes to the Patient ............................................. 6.1.7 Monitoring ECG with Disposable Pads ................................................................... 6.1.8 Monitoring ECG ................................................................................................................ 6.1.9 ECG Information on the Monitoring Screen ............................................................ 6.1.9 Selecting an ECG Lead .................................................................................................. 6.1.10 Selecting ECG Sensitivity .............................................................................................. 6.1.11 AUTO ......................................................................................................... 6.1.11 Changing ECG Settings ................................................................................................. 6.1.12 Changing Settings on the ECG Setup Screen ...................................................... 6.1.12 Turning the AC Hum Filter On/Off ......................................................................... 6.1.13 Changing the Time Constant Setting .................................................................... 6.1.14 Turning Pacing Pulse Rejection On/Off ................................................................. 6.1.15 Changing Heart Rate Upper/Lower Limit ............................................................... 6.1.16 Changing Settings on the QRS Setup Screen ...................................................... 6.1.17 Changing QRS Sync Sound Volume ..................................................................... 6.1.18 Changing QRS Sync Sound Source ..................................................................... 6.1.18 Operator's Manual TEC-5500 6C.1
Turning the VF/VT Alarm On or Off ...................................................................... 6.1.19 Use with an Electrosurgical Unit ..................................................................................... 6.1.20
SpO2 monitoring General ............................................................................................................................. 6.2.1 Preparing for SpO2 Monitoring ........................................................................................... 6.2.3 Preparation Flowchart ............................................................................................. 6.2.3 Selecting a Probe ................................................................................................... 6.2.3 Reusable Probes .......................................................................................... 6.2.4 Disposable Probes ....................................................................................... 6.2.5 Attaching the Probe to the Patient ......................................................................... 6.2.6 Connecting Probe to Defibrillator ............................................................................ 6.2.6 Monitoring SpO2 ................................................................................................................................................................................................... 6.2.8 SpO2 Information on the Monitoring Screen ............................................................ 6.2.8 Changing SpO2 Settings ................................................................................................... 6.2.9 Changing Settings on the SpO2 Setup Screen ........................................................ 6.2.9 Changing the Pulse Waveform Sensitivity ............................................................. 6.2.10 Selecting Sync Sound Pitch ................................................................................ 6.2.11 Changing the Pulse Rate Alarm Limits ................................................................ 6.2.12 Changing the SpO2 Alarm Limits .......................................................................... 6.2.13 Changing QRS Sync Sound Volume .................................................................... 6.2.13 Changing QRS Sync Sound Source ..................................................................... 6.2.13
CO2 monitoring General ............................................................................................................................. 6.3.1 CO2 Sensor Kit ....................................................................................................... 6.3.3 Preparing for CO2 Monitoring ............................................................................................ 6.3.6 Preparation Flowchart ............................................................................................. 6.3.6 Connecting the CO2 Sensor Kit to the Defibrillator .................................................. 6.3.6 Monitoring CO2 ...................................................................................................................................................................................................... 6.3.7 CO2 Information on the Monitoring Screen .............................................................. 6.3.7 Changing CO2 Settings ..................................................................................................... 6.3.8 Changing Settings on the CO2 Setup Screen ......................................................... 6.3.8 Changing the CO2 Scale ......................................................................................... 6.3.9 Changing the etCO2 Alarm Limits ......................................................................... 6.3.10 Changing the Respiration Rate Alarm Limits ........................................................ 6.3.11 Changing the APNEA Alarm Limit ......................................................................... 6.3.12 Inspection of Measuring Accuracy .................................................................................. 6.3.13 Daily Inspection of Measuring Accuracy ............................................................... 6.3.13 Inspection of Measuring Accuracy (Precise Method) ............................................ 6.3.13 Checking Procedure ................................................................................... 6.3.14
6C.2
6. MONITORING
General
ECG, SpO2 and CO2 can be monitored with this defibrillator. When monitoring starts, waveforms, measurement value of each parameter and/or bar graphs for CO2 or SpO2. are displayed on the screen.
Displaying the Monitoring Screen
To display the monitoring screen, turn the Energy/Mode Select control to the MONITOR position. You can select the display parameters in the Setup - Date/ Screen screen.
Screen Examples
Heart rate ECG lead QRS sync mark ECG sensitivity ECG waveform
CO2 value Respiration rate CO2 bar graph
SpO2 waveform
SpO2 value
Pulse rate
6.0.1
6. MONITORING
CO2 waveform
SpO2 bar graph
6.0.2
ECG Monitoring
Preparing for ECG Monitoring ........................................................................................... 6.1.2 Preparation Flowchart ............................................................................................ 6.1.2 Selecting a Lead .................................................................................................... 6.1.2 Number of Electrodes and Measuring Leads .......................................................... 6.1.3 Electrode Position .................................................................................................. 6.1.3 3 Electrode Leads ........................................................................................ 6.1.3 5 Electrode Leads ........................................................................................ 6.1.4 Selecting Electrodes and Lead ............................................................................... 6.1.5 Types of Electrodes and Lead ...................................................................... 6.1.5 Connecting the ECG Connection Cable or the JC-762V/JC763V Connection Cable to the Defibrillator ....................................................................................................... 6.1.6 Connecting the ECG Connection Cable to the Defibrillator ........................... 6.1.6 Connecting the JC-762V/JC763V Connection Cable to the Defibrillator ....... 6.1.6 Attaching Disposable ECG Electrodes to the Patient ............................................. 6.1.7 Monitoring ECG with Disposable Pads ................................................................... 6.1.8 Monitoring ECG ................................................................................................................ 6.1.9 ECG Information on the Monitoring Screen ............................................................ 6.1.9 Selecting an ECG Lead .................................................................................................. 6.1.10 Selecting ECG Sensitivity .............................................................................................. 6.1.11 AUTO ......................................................................................................... 6.1.11 Changing ECG Settings ................................................................................................. 6.1.12 Changing Settings on the ECG Setup Screen ...................................................... 6.1.12 Turning the AC Hum Filter On/Off ......................................................................... 6.1.13 Changing the Time Constant Setting .................................................................... 6.1.14 Turning Pacing Pulse Rejection On/Off ................................................................. 6.1.15 Changing Heart Rate Upper/Lower Limit ............................................................... 6.1.16 Changing Settings on the QRS Setup Screen ...................................................... 6.1.17 Changing QRS Sync Sound Volume ..................................................................... 6.1.18 Changing QRS Sync Sound Source ..................................................................... 6.1.18 Turning the VF/VT Alarm On or Off ...................................................................... 6.1.19 Use with an Electrosurgical Unit ..................................................................................... 6.1.20
6.1C.1
6.1C.2
6. MONITORING ECG is monitored by attaching disposable electrodes to the patient and connecting to the ECG input connector on the front panel. ECG is also monitored by attaching disposable pads to the patient and selecting PADDLE for the ECG lead. ECG waveform and heart rate are displayed.
6.1.1
6. MONITORING
Preparing for ECG Monitoring

Preparation Flowchart
1. Select the disposable ECG electrode and ECG connection cable. 2. Connect the ECG connection cable to the ECG input connector on the defibrillator. 3. Attach the disposable ECG electrodes to the patient and attach the ECG connection cable to the electrodes. 4. Monitoring starts. Set necessary settings. For handling accessories after use, refer to Section 10.
Selecting a Lead
NOTE
Follow the physicians instructions for lead position when available. Select the optimum lead according to the following guidelines: 1) Select the lead with the highest QRS wave amplitude and least difference in amplitude compared with a VPC or pacing pulse. 0.5 QRS1/QRS2 2 2) Select a lead with less than 0.2 mV amplitude of the P-wave. (with the sensitivity 1 and P amplitude is less than 2 mm on the screen) P 0.2 mV 3) Select a lead with a T-wave amplitude which is less than one-third of the QRS wave. T1 1/3QRS1, T2 1/3QRS2
QRS1 P T1 T2
QRS2
6.1.2
6. MONITORING
Number of Electrodes and Measuring Leads
The leads which can be monitored differ according to the type of ECG connection cable or electrode lead and number of electrodes used.
Lead Features
3 electrodes 5 electrodes
I, II, III I, II, III, aVR, aVL, aVF, V (V is one of V1 to V6)
Can measure at the thoracic wall. Similar to the standard 12 lead.
Electrode Position
NOTE
When attaching ECG electrodes for synchronized cardioversion or external pacing, avoid positions where paddles or pads are placed. When electrodes cannot be attached to the positions shown below (for example because of chest operation), a relatively stable ECG waveform can be obtained by attaching electrodes on both shoulder joints. 3 Electrode Leads Electrode Position
Symbol Lead Color (Clip Color) Electrode Position
R/RA
L/LA
R RA L LA F LL
Red (Red-beige) White (White-beige) Yellow (Yellow-beige) Black (Black-beige) Green (Green-beige) Red (Red-beige)
Right infraclavicular fossa Left infraclavicular fossa Lowest rib on the left anterior axillary line
F/LL
Lead Connection
Lead I
Lead II
Lead III
R/RA F/LL
L/LA
R/RA F/LL
L/LA
R/RA F/LL
L/LA
6.1. 3
6. MONITORING 5 Electrode Leads R/RA

C1/V1 C2/V2 C3/V3 C4/V4 C5/V5
L/LA
Electrode Position
Symbol Lead Color (Clip Color) Electrode Position
C6/V6
R RA L LA
Red (Red-beige) White (White-beige) Yellow (Yellow-beige) Black (Black-beige) Green (Green-beige) Red (Red-beige) Black (Black-beige) Green (Green-beige)
Right infraclavicular fossa Left infraclavicular fossa Left midclavicular line about 12-15 mm
N (RF/RL)
F/LL
F LL N (RF) N (RL)
above the iliac crest or the left edge of the backbone about 12-15 mm above the iliac crest. Right anterior axillary line at the same level as F. Any one of the C1 to C6 C1 (V1): Fourth intercostal space at the right border of the sternum C2 (V2): Fourth intercostal space at the left border of the sternum C3 (V3): Halfway between C2 (V2) and C4 (V4) C4 (V4): Fifth intercostal space on left midclavicular line C5 (V5): Left anterior axial line at the horizontal level of C4 (V4) C6 (V6): Left midaxillary line at the
C V
White (Brown-white) Brown (Blue-brown)
Lead Connection
Standard limb leads Lead I Lead II Lead III
L/LA
horizontal level of C4 (V4)
R/RA
L/LA
R/RA
L/LA
R/RA
F/LL N(RF/RL) N(RF/RL)
F/LL N(RF/RL)
F/LL
Monopolar limb leads aVR lead
aVL lead
R/RA
aVF lead
R/RA
L/LA
L/LA
R/RA L/LA
F/LL N(RF/RL) N(RF/RL)
F/LL N(RF/RL)
F/LL
Monopolar chest leads V1 to V6 leads

to
R/RA
L/LA
F/LL N(RF/RL)
6.1.4
6. MONITORING
Selecting Electrodes and Lead
Select the appropriate disposable ECG electrodes and ECG connection cable or electrode lead according to the number of electrodes (lead).
WARNING
When using a defibrillator together with the monitor, use Ag/AgCl electrodes. Other types of electrodes, stainless steel in particular, will adversely affect the ECG waveform by slowing the baseline recovery on the monitor and result in no monitoring immediately following defibrillation.
CAUTION
Only use Nihon Kohden specified parts and accessories. When other parts or accessories are used, the defibrillator heats up and may be damaged, and monitoring stops.
Types of Electrodes and Lead

Disposable Electrodes ECG connection cable or Electrode Lead
No. of Electrodes
Connection cable
ECG connection cable BC-763V
Not necessary
3 (I, II, III)
Electrode lead BR-018P, BR-019P, BR-024P, BR-033P, BR-034P, BR-903P
JC-762V/763V connection cable
Vitrode C-150 (Recommended) ECG connection cable BC-765V Example: JC-762V Not necessary
5 (I, II, III, aVR, aVL, aVF, any one of the V1 to V6) Electrode lead BR-020P, BR-021P, BR-026P JC-762V connection cable
6.1.5
6. MONITORING
Connecting the ECG Connection Cable or the JC-762V/JC763V Connection Cable to the Defibrillator
Connecting the ECG Connection Cable to the Defibrillator Connect the ECG connection cable to the ECG input connector on the front panel of the defibrillator.
Connecting the JC-762V/JC763V Connection Cable to the Defibrillator 1. Connect electrode leads to the connector of the JC-762V or JC-763V connection cable. 2. Connect the JC-762V or JC-763V connection cable to the ECG input connector on the front panel of the defibrillator.
Attaching Disposable ECG Electrodes to the Patient
CAUTION
Do not reuse disposable items.
NOTE
To maintain good contact between the electrode and skin, check that the paste of the disposable ECG electrode is not dry. When contact of the disposable ECG electrode becomes poor, replace the electrode with a new one immediately. Otherwise, contact impedance between the skin and electrode increases and the correct ECG cannot be obtained. If the contact is bad before the expiration date on the package, replace the electrode with a new one. 1. Shave excess hair. With a piece of cotton pad moistened with alcohol, clean the patients skin where the electrodes should be mounted. Avoid wrinkled or uneven skin areas. Wipe off the alcohol with a dry cotton pad. 6.1.6 Operator's Manual TEC-5500
6. MONITORING
NOTE
To obtain a stable ECG waveform rub the skin with Skinpure skin preparation gel. 2. Open the disposable electrode package and take out the electrode. 3. Remove the gel cover from the electrode. Be careful not to touch the adhesive side.
4. Attach the disposable ECG electrode to the previously cleaned skin. Avoid wrinkled and uneven skin areas.
NOTE
If the contact becomes bad because of sweat or body movement, replace the electrode with a new one. 5. Clip the electrode lead or ECG connection cable onto the electrode.
NOTE
Extra length Check that electrodes are not pulled by the ECG connection cable or electrode lead. 6. Fasten the electrode lead to the skin with surgical tape with an extra length of wire between the tape and the electrode. This prevents body movement from moving the electrode lead.
Monitoring ECG with Disposable Pads
You can monitor patients ECG using the disposable pads instead of ECG monitoring electrodes. However, 3 electrode lead ECG and 5 electrode lead ECG are not available with disposable pads. For connecting the pad adaptor to the defibrillator, attaching the disposable pads to the patient and attachment site, refer to Section 4.
WARNING
When using an ESU, use this defibrillator only in the MONITOR mode and use the ECG electrodes for monitoring. Do not monitor ECG with disposable pads, external paddles or internal paddles. If ECG is monitored with pads or paddles, high frequency energy from the ESU causes abnormal current to flow in the patient and unexpected discharge. This may damage the defibrillator. Failure to follow the warnings below may cause skin burn or insufficient energy discharge and insufficient pacing current to the heart. - Do not reuse disposable pads. - If the pad package is torn, dispose of the pads and do not use them. - Do not use the pads if they are past the expiration date on the package. 6.1.7
6. MONITORING WARNING - continued - Use the disposable pads as soon as possible after opening the package. - Do not use the disposable pads if the gel has become dry or if the gel has become abnormal (the gel has become liquid or is coming off the edges of the pad, etc). - Do not use the disposable pads if the gel is dark brown or dark brown gel is on the protective sheet. If any pad or connector gets wet, replace it with a new one. If a wet pad or connector is used, it may cause electrical shock.
CAUTION
NOTE
Follow all disposable pad labeling instructions. Before attaching the disposable pads to the patient, clean the skin where the pads will be attached. If the skin is moist, use a cotton swab to dry it.
6.1.8
6. MONITORING
Monitoring ECG
When electrodes are attached to the patient and cables are connected properly, ECG appears on the screen.
CAUTION
When the Check ECG Electrodes message is displayed, ECG is not monitored properly and the ECG alarm does not function. Check the electrode, electrode leads and connection cord, and if necessary, replace with new ones.
ECG Information on the Monitoring Screen

Heart rate ECG Lead QRS sync mark Sensitivity ECG waveform
6.1.9
6. MONITORING
Selecting an ECG Lead

Select the lead for ECG waveform. The leads which can be selected depend on the instrument mode (defibrillation mode, AED mode, PACING mode, MONITOR mode) and the number of electrodes used. Press the ECG lead key to change the ECG lead. When the key is pressed, the ECG lead changes as below.
NOTE
When using 5 electrode leads, select 5 leads at ECG lead on the System Setup screen. In defibrillation or MONITOR mode 3 electrode leads: PADDLE I II III AUX* (TEST)*** PADDLE... 5 electrode leads: PADDLE I II III aVR aVL aVF V** AUX* (TEST)*** PADDLE... In PACING mode 3 electrode leads: I II III (TEST)*** I... 5 electrode leads: I II III aVR aVL aVF V** (TEST)*** I... In AED mode 3 electrode leads: PADDLE only 5 electrode leads: PADDLE only
AUX displays ECG waveform from the JC-761V External ECG cable. In 5 electrode leads, AUX (external ECG input) displays the same ECG waveform as V. ** V is one of the chest leads V1 to V6. *** When you set Test lead to OFF on the System Setup screen, TEST cannot be selected.
NOTE
With the PADDLE lead, a patient with an implanted pacemaker cannot be monitored correctly. Select a lead so that the whole waveform is displayed on the screen and the T waveform is not much higher than the QRS waveform. Otherwise, QRS cannot be recognized correctly. When the defibrillator miscounts the narrow width QRS, set Pacing Pulse Reject to OFF on the ECG Setup screen and confirm that QRS is correctly recognized.
6.1.10
6. MONITORING
Selecting ECG Sensitivity

Select the sensitivity of the ECG waveform to be monitored. This sensitivity is applied to the QRS detection sensitivity. For stable QRS detection, select the sensitivity so that the amplitude of the QRS is larger than 1 cm. Setting range: 1/4, 1/2, 1 (default setting), 2, 4, AUTO* * AUTO can only be selected in monitoring mode. Press the ECG Sensitivity key on the front panel to change the ECG sensitivity. When the key is pressed, sensitivity changes as below. Monitor mode: 1/4 1/2 1 2 4 AUTO 1/4 Defibrillation, pacing, AED, paddle lead mode: 1/4 1/2 1 2 4 1/4
AUTO When you select AUTO sensitivity, the appropriate sensitivity is automatically selected. The selected sensitivity is displayed at the left upper of the screen.
NOTE
AUTO sensitivity is not possible when there is noise. QRS waveform amplitude and selected sensitivity
QRS amplitude AUTO sensitivity Display
< 5 mm < 10 mm < 20 mm < 40 mm more than 40 mm
4 2 1 1/2 1/4
AG 4 AG 2 AG 1 AG 1/2 AG 1/4
When AUTO is selected in MONITOR mode and the screen changes to another screen, the sensitivity is not AUTO any more. (For example) AG 2 in MONITOR mode screen changes to defibrillation screen. 2 in defibrillation mode screen changes to MONITOR mode 2 in MONITOR mode (the sensitivity does not automatically return to AUTO.)
6.1.11
6. MONITORING
Changing ECG Settings

The following settings can be changed for ECG monitoring.
Item Description (default settings is underlined)
AC hum filter
When set to ON, the hum filter automatically reduces AC interference from the ECG Set the time constant for ECG display in MONITOR mode. When set to ON, it allows correct heart rate counting when the patient has an implanted pacemaker. Set the upper and lower limit of the heart rate alarm. Set the QRS sync sound volume. Select the source of the QRS sync sound. Select whether or not to detect VF/VT.
ON, OFF
Time Constant Pacing Pulse Reject
3.2s, 0.32s ON, OFF
HR alarm QRS Volume QRS Sound VF/VT Alarm
Upper: 20 to 300, OFF (140) Lower: OFF, 15 to 295 (40) 0 to 4 (3) ECG, SpO2 ON, OFF
Changing Settings on the ECG Setup Screen
2. Select ECG Setup with the Item or Item key and press the SET key. The ECG Setup screen appears.
6.1.12
6. MONITORING 3. Press the Item key to select the item. When you press the key, selected item switches. 4. Press the or key to change settings. Repeat steps 3 and 4 to set all items. 5. Turn the Energy/Mode Select control to the MONITOR position to return to the monitoring screen appears.
Turning the AC Hum Filter On/Off
When ON is selected, the hum filter automatically reduces AC interference from the ECG. This filter also prevents ECG baseline drift in MONITOR mode. ON AC interference is reduced. Select ON when there is much AC interference or when using an electrosurgical unit. (Default setting: ON) OFF: AC interference is not reduced. Select when you want to monitor unfiltered waveforms for example when examining a QRS change in ECG.
NOTE
The AC hum filter is fixed to ON when PADDLE is selected as an ECG source lead. When the hum filter is set to ON, some QRS waveforms are distorted greatly. 1. On the ECG Setup screen, select AC hum filter with the Item key.
6.1.13
6. MONITORING
Changing the Time Constant Setting
When ECG baseline drift is large, set the Time constant to 3.2 s (Default setting: 0.32 s).
NOTE
The Time Constant is fixed to 0.32 s when PADDLE is selected as an ECG source lead. The Time Constant is fixed to 3.2 s when AUX is selected as a ECG source lead. 1. On the ECG Setup screen, select Time Constant with the Item key.
2. Select 0.32 s or 3.2 s or with the or key.
6.1.14
6. MONITORING
Turning Pacing Pulse Rejection On/Off
This setting selects whether or not to reject pacemaker spike counting and allow correct heart rate counting when monitoring the patient who has an implanted cardiac pacemaker. ON: Reject pacemaker spike counting and allow correct heart rate counting. Select ON when the patient has an implanted cardiac pacemaker. When the defibrillator detects an implanted pacemaker pulse output, is displayed below the waveform. OFF: Pacing pulses are not detected. Select OFF when you monitor a premature baby or infant and the defibrillator miscounts the narrow width QRS. (Default setting: OFF)
WARNING
Keep pacemaker patients under close observation. The pacemaker rate may be counted during cardiac arrest and certain arrhythmias. Do not rely only on heart rate alarms and the displayed heart rate. With the pacing pulse rejection ON, narrow width QRS of a premature baby or infant cannot be detected correctly and the defibrillator may miscount QRS. In this case, set the pacing pulse rejection to OFF. Turn the pacing pulse rejection to OFF when monitoring a child. With the pacing pulse rejection ON, narrow width QRS of a child cannot be detected correctly and the defibrillator may miscount QRS.
CAUTION
* Pacing failure is a state where pacing spike is output but ventricular or atrial reaction does not occur. Turn the pacing pulse rejection to On when monitoring a pacemaker patient. Otherwise QRS and pacemaker spike might not be distinguished and pacing failure might not be recognized.
NOTE
PADDLE lead has low frequency characteristics. Therefore, when you monitor a patient with an implanted pacemaker in PADDLE lead, a pacemaker spike may be displayed like a QRS. 1. On the ECG Setup screen, select Pacing Pulse Reject with the Item key.
2. Select ON or OFF with the or key. Operator's Manual TEC-5500 6.1.15
6. MONITORING
Changing Heart Rate Upper/Lower Limit
Set the upper and lower limit of the heart rate alarm. Setting range:
Item Range Step Default setting
Upper HR (heart rate) beat/min Lower
20 to 300, OFF OFF, 15 to 295
5 5
140 40
NOTE
If you increase the upper limit over 300, the upper limit becomes OFF. If you decrease the lower limit below 15, the lower limit becomes OFF.
CAUTION
When the upper or lower alarm limit is turned off, there will be no heart rate upper or lower alarm for that limit.
1. On the ECG Setup screen, select the heart rate upper limit or lower limit of the heart rate alarm with the Item key.
The arrow in the HR bar graph indicates the current heart rate. 2. Set the upper or lower limit with the or key.
6.1.16
6. MONITORING
Changing Settings on the QRS Setup Screen
2. Select QRS Setup with the Item or Item key and press the SET key. The QRS Setup screen appears.
3. Press the Item key to select the item. When you press the key, selected item switches. 4. Press the or key to change settings. Repeat steps 3 and 4 to set all items. 5. Turn the Energy/Mode Select control to the MONITOR position to return to the monitoring screen appears.
6.1.17
6. MONITORING
Changing QRS Sync Sound Volume
The QRS sync sound volume can be set from 0 to 4 (Default setting: 3) 1. On the QRS Setup screen, select QRS Volume with the Item key.
2. Select the volume with the or key.
Changing QRS Sync Sound Source
Select the QRS sync sound source from ECG or SpO2 (pulse wave) (Default setting: ECG). 1. On the QRS Setup screen, select QRS Sound with the Item key.
2. Select the QRS sync sound source with the or key.
6.1.18
6. MONITORING
Turning the VF/VT Alarm On or Off
A shockable rhythm (ventricular fibrillation and ventricular tachycardia) is detected when the VF/VT Alarm is set to ON (Default setting: ON) in the monitor mode. When a shockable rhythm is detected, Check Patient message appears on the screen.
NOTE
When monitoring the ECG waveforms with the external paddles or internal paddles, the VF/VT alarm is turned off. In AED mode, the VF/VT alarm is always turned on regardless of this setting. 1. On the QRS Setup screen, select VF/VT Alarm with the Item key.
6.1.19
6. MONITORING
Use with an Electrosurgical Unit

For use with an electrosurgical unit (ESU), this defibrillator has a circuit to protect the patient from skin burn and to reduce ESU interference on the ECG waveform. However, the effectiveness of this circuit depends on electrode position and defibrillator setup. With an ESU, pay attention to the following points.
WARNING
When the defibrillator is used with an electrosurgical unit (ESU), firmly attach the entire area of the ESU return plate. Otherwise, the current from the ESU flows into the electrodes of the defibrillator, causing electrical burn where the electrodes are attached. For details, refer to the ESU manual. When using an ESU, use this defibrillator only in the MONITOR mode and use the ECG electrodes for monitoring. Do not monitor ECG with disposable pads, external paddles or internal paddles. If ECG is monitored with pads or paddles, high frequency energy from the ESU causes abnormal current to flow in the patient and unexpected discharge. This may damage the defibrillator.
CAUTION
Install the defibrillator and ESU appropriately and perform equipotential grounding. Otherwise, noise from the ESU may be falsely recognized as QRS and ECG monitoring might not be performed properly.
Arrangement Install the defibrillator as far from the ESU as possible. If possible, locate them on opposite sides of the operating table. Power Supply Noise from the ESU may interfere with the ECG signal through the AC power line. Supply power to the defibrillator and ESU from different outlets located as far from each other as possible. Do the equipotential grounding properly.
Defibrillator
3 electrodes ESU
Grounding defibrillator
Grounding ESU
Bed
6.1.20
6. MONITORING Measure with 3-electrode Lead Use the minimum number of electrodes. Use new electrodes whose gel is not dry. Minimizing Noise 1. Select an ECG lead where the active ECG electrodes are located as far from the incision as possible. 2. Position the + and electrodes as close as possible. 3. Select the leads where the angle () between the active electrodes and the incision is as small as possible. 4. Set the electrosurgical return plate as close to the incision as possible.
As far as possible from electrode and as near as possible to incision.
Return plate
Incision
Make this angle,
,small
Monitor pulse rate by measuring SpO2. The heart rate is unstable because of an ESU. Set the following items on the ECG Setup screen. AC Hum filter: ON Time constant: 0.32 s
6.1.21
6. MONITORING
6.1.22
SpO2 Monitoring
General ............................................................................................................................. 6.2.1 Preparing for SpO2 Monitoring ........................................................................................... 6.2.3 Preparation Flowchart ............................................................................................. 6.2.3 Selecting a Probe ................................................................................................... 6.2.3 Reusable Probes .......................................................................................... 6.2.4 Disposable Probes ....................................................................................... 6.2.5 Attaching the Probe to the Patient ......................................................................... 6.2.6 Connecting Probe to Defibrillator ............................................................................ 6.2.6 Monitoring SpO2 ................................................................................................................................................................................................... 6.2.8 SpO2 Information on the Monitoring Screen ............................................................ 6.2.8 Changing SpO2 Settings ................................................................................................... 6.2.9 Changing Settings on the SpO2 Setup Screen ........................................................ 6.2.9 Changing the Pulse Waveform Sensitivity ............................................................. 6.2.10 Selecting Sync Sound Pitch ................................................................................ 6.2.11 Changing the Pulse Rate Alarm Limits ................................................................ 6.2.12 Changing the SpO2 Alarm Limits .......................................................................... 6.2.13 Changing QRS Sync Sound Volume .................................................................... 6.2.13 Changing QRS Sync Sound Source ..................................................................... 6.2.13
6.2C.1
6.2C.2
6. MONITORING
General
SpO2 is monitored by attaching a probe to the patient and connecting the SpO2 adapter cable to the SpO2/CO2 connector on the defibrillator. For proper SpO2 probe attachment and use, refer to the operators manual of the SpO2 probe.
WARNING
SpO2 Measurement may be incorrect in the following cases. - When the patients carboxyhemoglobin or methemoglobin increases abnormally - When dye is injected in the blood - When using an electrosurgical unit - During CPR - When measuring at a site with venous pulse - When there is body movement - When the pulse wave is small (insufficient peripheral circulation) Check the circulation condition by observing the skin color at the measurement site and pulse waveform. Change the measurement site every 8 hours. The skin temperature may increase at the attached site by 2 or 3C (4 or 5F) and cause a burn or pressure necrosis. When using the probe on the following patients, take extreme care and change the measurement site more frequently according to symptoms and degree. - Patient with a fever - Patient with a peripheral circulation insufficiency - Neonate or low birth weight infant with delicate skin When not monitoring SpO2, disconnect the SpO2 connection cord from the bedside monitor. Otherwise, noise from the probe sensor may interfere and incorrect data is displayed on the screen. When using probes other than the TL-201T finger probe, to avoid poor circulation, do not wrap the tape too tight. Check the blood circulation condition by observing the skin color and congestion at the skin peripheral to the probe attachment site. Even for short-term monitoring, there may be burn or pressure necrosis from poor blood circulation, especially on neonates or low birth weight infants whose skin is delicate. Accurate measurement cannot be performed on a site with poor peripheral circulation. When measuring SpO2 of a patient who is in a state of shock or in CPR (cardiopulmonary resuscitation), the acquired SpO2 data may be incorrect due to the patients body movement. Do not use the probe during MRI examination because it may cause skin burn on the probe attachment area. For details, follow the MRI operators manual.
6.2.1
6. MONITORING
CAUTION
For long term monitoring, check the circulation condition by observing the skin color the measureing site. To avoid circullation insufficiency and skin burn, change the measurement site every specified hours. Reffer to the operators manual of the plofge Do not pull or bend the probe cable, and do not put caster feet on the probe cable. Do not immerse the probe cable in chemical solutions or water. Failure to follow these instructions may cause cable discontinuity, short circuit, skin burn on the patient and incorrect measurement data. Replace any broken probe with a new one. Turn off the power of mobile phones, small wireless devices and other devices which produce strong electromagnetic interference around a patient (except for devices allowed by the hospital administrator). Radio waves from devices such as mobile phones or small wireless devices may be mistaken as pulse waves and the displayed data may be incorrect. Only use the specified probes. Otherwise SpO2 cannot be monitored properly and instrument performance may be degraded. Do not use a probe which is past the expiration date on the package. Do not use a damaged or disassembled probe. It causes incorrect measurement and may injure the patient. The disposable probe is not sterilized. Use the disposable probe only for a single patient. Never reuse the disposable probe for another patient because it causes cross infection. If the attachment site is dirty with blood or bodily fluids, clean the attachment site before attaching the probe. If there is nail polish on the attachment site, remove the polish. Otherwise, the amount of transmitted light decreases, and measured value may be incorrect or measurement cannot be performed. If the skin gets irritated or redness appears on the skin from the probe, change the attachment site or stop using the probe. Take extreme care for the patients with delicate skin. If the probe is attached to the same limb that is used for NIBP measurement or an IBP catheter, the blood circulation at the attachment site is affected and the measurement might not be correct. Attach the probe to a limb where the blood circulation is not affected. If patients nail is long, cut it or attach the probe to another finger. The probe cannot be attached properly to a finger with a long nail. Refer to the probe instruction manual for details. Neonatal skin is delicate. Remove the probe and tape carefully and slowly. When removing the probe from the attachment tape, do not pull the sensor cable because this can damage the cable.
6.2.2
6. MONITORING
Preparing for SpO2 Monitoring

1. Select the probe. 2. Connect the probe to the SpO2 adapter and connect the SpO2 adapter to the SpO2/CO2 connector on the defibrillator. 3. Attach the probe to the patient. 4. Monitoring starts. Set necessary settings. For handling accessories after use, refer to Section 10.
Selecting a Probe
Select the appropriate probe according to the purpose.
WARNING
Do not use the probe during MRI examination because it may cause skin burn on the probe attachment area. For details, follow the MRI operators manual.
CAUTION
Only use the specified probes. Otherwise SpO2 cannot be monitored properly and instrument performance may be degraded. Do not use a probe which is past the expiration date on the package. Do not use a damaged or disassembled probe. It causes incorrect measurement and may injure the patient.
6.2.3
6. MONITORING Reusable Probes

Model Subject (Weight) Attachment Site SpO2 adapter
Finger Probe TL-201T
Adults, children (Weight more than 20 kg)
Finger
JL-951T3
Multi-site Probe TL-220T
Adults, children, infants, neonates (Weight more than 3 kg) Neonates (Weight less than 3 kg)
Finger or toe
Instep
6.2.4
6. MONITORING Disposable Probes
CAUTION
The disposable probe is not sterilized. Use the disposable probe only for a single patient. Never reuse the disposable probe for another patient because it causes cross infection.
Model
Subject (Weight)
Attachment Site
SpO2 adapter
TL-251T
Adults (Weight more than 30 kg)
Finger or toe
JL-951T3
TL-252T
Children (Weight from 3 to 40 kg)
Finger or toe
TL-253T
Neonates (Weight less than 3 kg)
Instep and sole
TL-051S/052S
Adults (Weight more than 50 kg)
Finger
Neonates Cable length TL-051S: 80 cm TL-052S: 160 cm TL-061S/062S Adults, children (Weight from 15 to 50 kg) (Weight less than 3 kg)
Instep and sole
Finger
Children, infants Cable length TL-061S: 80 cm TL-062S: 160 cm TL-260S

Sponge attachment tape
Toe
(Weight from 3 to 15 kg)
Adults, children (Weight more than 3 kg)
Finger or toe
Neonates (Weight less than 3 kg)
Instep or sole
Low birth weight infants (Weight less than 1 kg)
Instep or sole
6.2.5
6. MONITORING
Connecting Probe to Defibrillator
1. Connect the probe to the sensor connector on the JL-951T3 SpO2 adapter.
JL-951T3 SpO2 adapter
Probe 2. Connect the JL-951T3 SpO2 adapter cable to the SpO2/CO2 connector on the defibrillator.
Attaching the Probe to the Patient
For proper SpO2 probe attachment and use, refer to the operators manual of the SpO2 probe.
WARNING
When using probes other than the TL-201T finger probe, to avoid poor circulation, do not wrap the tape too tight. Check the blood circulation condition by observing the skin color and congestion at the skin peripheral to the probe attachment site. Even for short-term monitoring, there may be burn or pressure necrosis from poor blood circulation, especially on neonates or low birth weight infants whose skin is delicate. Accurate measurement cannot be performed on a site with poor peripheral circulation. Check the circulation condition by observing the skin color at the measurement site and pulse waveform. Change the measurement site every 8 hours. The skin temperature may increase at the attached site by 2 or 3C (4 or 5F) and cause a burn or pressure necrosis. When using the probe on the following patients, take extreme care and change the measurement site more frequently according to symptoms and degree. - Patient with a fever - Patient with a peripheral circulation insufficiency - Neonate or low birth weight infant with delicate skin
6.2.6
6. MONITORING
CAUTION
If the attachment site is dirty with blood or bodily fluids, clean the attachment site before attaching the probe. If there is nail polish on the attachment site, remove the polish. Otherwise, the amount of transmitted light decreases, and measured value may be incorrect or measurement cannot be performed. For long term monitoring, check the circulation condition by observing the skin color the measureing site. To avoid circullation insufficiency and skin burn, change the measurement site every specified hours. Reffer to the operators manual of the plobe you use. If the skin gets irritated or redness appears on the skin from the probe, change the attachment site or stop using the probe. Take extreme care for the patients with delicate skin. When the probe is attached on an appropriate site with sufficient circulation and an error message about probe attachment repeatedly appears, the probe may be deteriorated. Replace it with a new one. If the probe is attached to the same limb that is used for NIBP measurement or an IBP catheter, the blood circulation at the attachment site is affected and the measurement might not be correct. Attach the probe to a limb where the blood circulation is not affected. If patients nail is long, cut it or attach the probe to another finger. The probe cannot be attached properly to a finger with a long nail. Neonatal skin is delicate. Remove the probe and tape carefully and slowly. When removing the probe from the attachment tape, do not pull the sensor cable because this can damage the cable. Refer to the probe instruction manual for details.
6.2.7
6. MONITORING
Monitoring SpO2
When the preparation is done properly, the SpO2 value and pulse waveform appear on the screen.
CAUTION
When the probe is attached on an appropriate site with sufficient circulation and an error message about probe attachment repeatedly appears, the probe may be deteriorated. Replace it with a new one. Alarms about a parameter do not occur until the measurement of the parameter starts. When a message indicates a faulty probe or faulty SpO2 adapter, stop monitoring and replace the probe or SpO2 adapter with a new one.
NOTE
When the Searching for SpO2 pulse message is displayed for a long time, it means that the detected pulse is too small to measure. Reposition the probe.
SpO2 Information on the Monitoring Screen
SpO2 bar graph Indicates that the upper or lower alarm limit is set to off. 2nd wave setting (Setup screen Date/Screen): CO2 or OFF
SpO2
Pulse rate
SpO2 waveform
2nd wave setting (Setup screen Date/Screen): SpO2, SpO2/CO2 or SpO2/CO2
When the SpO2 measurement is unstable, the M mark appears beside the SpO2 value. 6.2.8 Operator's Manual TEC-5500
6. MONITORING
Changing SpO2 Settings

The following settings can be changed for SpO2 monitoring.
Item Description (default settings is underlined)
Sens SpO2 Sound PR SpO2 QRS Volume QRS Sound
Set the pulse wave sensitivity When set to ON, the pitch of the sync sound changes according to SpO2 value Set the upper and lower limit of pulse rate alarm. Set the upper and lower limit of the SpO2 alarm. Set the QRS sync sound volume. Select the source of the QRS sync sound.
AUTO, 1/8, 1/4, 1/2, 1, 2, 4, 8 ON, OFF Upper: 20 to 300, OFF (140) Lower: OFF, 15 to 295 (40) Upper: 51 to 100, OFF (OFF) Lower: OFF, 50 to 99 (90) 0 to 4 (3) ECG, SpO2
Changing Settings on the SpO2 Setup Screen
2. Select SpO2 Setup with the Item or Item key and press the SET key. The SpO2 Setup screen appears.
6.2.9
6. MONITORING
NOTE
When an SpO2 probe is not connected to the SpO2/CO2 connector on the defibrillator, the SpO2 setup screen is not displayed. If not displayed, turn the Energy/Mode Select control to the MONITOR position, confirm the SpO2 cable connection then turn the Energy/ Mode Select control to the SETUP position. 3. Press the Item key to select the item. When you press the key, the selected item switches. 4. Press the or key to change settings. Repeat steps 3 and 4 to set all items. 5. Turn the Energy/Mode Select control to the MONITOR position. The monitoring screen appears.
Changing the Pulse Waveform Sensitivity
The sensitivity determines the size of the waveform on both the screen and recording paper. Setting range: AUTO, 1/8, 1/4, 1/2, 1 (default setting), 2, 4, 8 When you select AUTO sensitivity, the appropriate sensitivity is automatically selected. 1. On the SpO2 Setup screen, select Sens with the Item key.
2. Select the sensitivity with the or key. AUTO 1/8 1/4 1/2 1 2 4 8
6.2.10
6. MONITORING
Selecting Sync Sound Pitch
When this item is set to ON, the pitch of the sync sound changes according to SpO2 value, so you can know the SpO2 change by sound. Fixed sound is produced when only SpO2 is measured. ON: The pitch of the sync sound changes as shown in the table below. OFF: The pitch of the sync sound is fixed (Default setting: OFF).
SpO2
Tone
100% to 81% 80% or less
Changes in 20 steps corresponding to SpO2 value (steps of 1). Pitch for 81%
When the SpO2 adapter cable is disconnected from the defibrillator, the sync sound automatically becomes the pitch for OFF. When the SpO2 adapter cable is connected again, the pitch returns to the previous pitch.
1. On the SpO2 Setup screen, select SpO2 Sound with the Item key.
6.2.11
6. MONITORING
Changing the Pulse Rate Alarm Limits
CAUTION
When the upper or lower alarm limit is turned off, there will be no upper or lower pulse rate alarm for that limit.
1. On the SpO2 Setup screen, select the upper or lower value of the pulse rate (PR) limit with the Item key.
The arrow in the PR bar graph indicates the current pulse rate. 2. Select the upper or lower limit with the or key.
Upper PR beat/min Lower
20-300, OFF OFF, 15-295
5 5
140 40
NOTE
6.2.12
6. MONITORING
Changing the SpO2 Alarm Limits
CAUTION
When the upper or lower alarm limit is turned off, there will be no upper or lower SpO2 alarm for that limit.
1. On the SpO2 Setup screen, select the upper or lower SpO2 alarm limit with the Item key.
The arrow in the SpO2 bar graph indicates the current SpO2 value. 2. Select the upper or lower limit with the or key.
Upper SpO2 % Lower
51 to 100, OFF OFF, 50 to 99
1 1
OFF 90
NOTE
Changing QRS Sync Sound Volume
Refer to ECG-Monitoring - Changing QRS Sync Sound Volume in Section 6.1.
Changing QRS Sync Sound Source
Refer to ECG-Monitoring - Changing QRS Sync Sound Source in Section 6.1.
6.2.13
6. MONITORING
6.2.14
CO2 Monitoring
General ............................................................................................................................. 6.3.1 CO2 Sensor Kit ....................................................................................................... 6.3.3 Preparing for CO2 Monitoring ............................................................................................ 6.3.6 Preparation Flowchart ............................................................................................. 6.3.6 Connecting the CO2 Sensor Kit to the Defibrillator .................................................. 6.3.6 Monitoring CO2 ...................................................................................................................................................................................................... 6.3.7 CO2 Information on the Monitoring Screen .............................................................. 6.3.7 Changing CO2 Settings ..................................................................................................... 6.3.8 Changing Settings on the CO2 Setup Screen ......................................................... 6.3.8 Changing the CO2 Scale ......................................................................................... 6.3.9 Changing the etCO2 Alarm Limits ......................................................................... 6.3.10 Changing the Respiration Rate Alarm Limits ........................................................ 6.3.11 Changing the APNEA Alarm Limit ......................................................................... 6.3.12 Inspection of Measuring Accuracy .................................................................................. 6.3.13 Daily Inspection of Measuring Accuracy ............................................................... 6.3.13 Inspection of Measuring Accuracy (Precise Method) ............................................ 6.3.13 Checking Procedure ................................................................................... 6.3.14
6.3C.1
6.3C.2
6. MONITORING
General
CO2 monitoring by the mainstream method is performed by connecting the TG901T3T or G-921T3 CO2 sensor kit to the patients respiration circuit and to the SpO2/CO2 connector on the defibrillator. For the proper CO2 sensor attachment and use, refer to the operators manual of the CO2 sensor
WARNING
When performing defibrillation or cardioversion during CO2 monitoring with the CO2 sensor kit, remove the sensor from the patient. When the sensor cannot be removed, do not touch the sensor cable because the discharged energy may cause serious electrical burn, shock or other injury. With the TG-901T3 CO2 sensor kit, measurements are based on the assumption of no CO2 gas in the inspiration. The CO2 concentration in the respiration is calculated by taking the CO2 concentration in the inspiration as 0 mmHg. Therefore, measuring CO2 by connecting the CO2 sensor kit to a patient under mouth-to-mouth respiration or to a Jackson Rees circuit or Mapleson D circuit where CO2 gas may be present during inspiration may result in the acquired data being lower than the actual value. With the TG-901T3 CO2 sensor kit, this monitor cannot monitor CO2 of patients weighing less than 10 kg (22 lbs). Do not use the airway adapter on neonates because the dead space volume of the airway adapter is about 5 mL. When using the YG-101T airway adapter on children or patients with low ventilatory amount, the CO2 may mix in the inspiration due to the airway adapters dead space volume (5 mL), resulting in inaccurate measured values or difficulty in detecting no breath. Perform ventilation taking into consideration the 5 mL dead space volume. Before MRI examination, remove the CO2 sensor kit from the patient. Failure to follow this warning may cause serious electrical burn on the patient due to local heating caused by dielectric electromotive force. For details, refer to the MRI operators manual.
CAUTION
The CO2 data may be inaccurate when monitoring a patient with an extremely high respiration rate or irregular respiration. Read the measured values carefully. Measured value may be incorrect when the operating temperature changes greatly. When using an anesthetic instrument with a volatile anesthetic agent, the CO2 measurement may be inaccurate. Operator's Manual TEC-5500 6.3.1
6. CO2 MONITORING
NOTE
The measurement may be inaccurate when the defibrillator is used in the following conditions. Read the measured values carefully. When there is high concentration nitrous oxide gas in the airway adapter. When used in places with low atmospheric pressure such as at high altitude. When used in environments with sudden temperature changes. When used in environments with severe humidity. When used for patients with irregular spontaneous respiration.
6.3.2
6. MONITORING
CO2 Sensor Kit WARNING

Do not use the airway adapter on neonates because the dead space volume of the airway adapter is about 5 mL. When using the YG-101T airway adapter on children or patients with low ventilatory amount, the CO2 may mix in the inspiration due to the airway adapters dead space volume (5 mL), resulting in inaccurate measured values or difficulty in detecting apnea. Perform ventilation taking into consideration the 5 mL dead space volume. When using the YG-121T nasal adapter on children or patients with low ventilatory amount, the CO2 may mix in the inspiration due to the nasal adapters dead space volume (1.2 mL), resulting in inaccurate measured values or difficulty in detecting apnea. Perform ventilation taking into consideration the 1.2 mL dead space volume. When you use YG-122T together with an oxygen cannula, check that the oxygen cannula is correctly attached on the patient by referring to other parameters and by observing the patient periodically. If arterial oxygen saturation does not increase, immediately stop using the oxygen cannula with the CO2 sensor kit and select another way to supply oxygen. The only oxygen cannula that can be used with YG-122T is #1103 manufactured by HUDSON RCI. Do not use any other oxygen cannula. Other oxygen cannulas cannot be attached and oxygen cannot be delivered to the patient through the nostrils. Check that the oxygen cannula tube is not bent, broken, or blocked by the nasal tube. If the ends of the oxygen cannula tube turn too far up or down, it causes insufficient oxygen supply or the CO2 value may be incorrect.
CAUTION
The airway adapter/nasal adapter is non-sterilized and disposable. Use only for a single patient and single use. Failure to follow this instruction causes cross infection. Do not sterilize the airway adapter. Safety cannot be guaranteed if the airway adapter is sterilized. Use the Nihon Kohden specified airway adapter. With the TG-901T3 CO2 sensor kit, secure the CO2 sensor to the respiration circuit so that the transparent film of the airway adapter is perpendicular to the floor. If the transparent film is parallel to the floor, water droplets may get onto the transparent film and affect the measurement accuracy.
6.3.3
6. CO2 MONITORING
CAUTION continued
Failure to follow the instructions below degrades the anti-fogging ability of the transparent film and results in incorrect measurement. - Replace the airway adapter/nasal adapter with a new one every 24 hours. - Replace the airway adapter/nasal adapter with a new one if blood, sputum or mucus adhere to the transparent film. - Do not damage the transparent film. Do not let dust or detergent contact the transparent film. Do not touch, wipe or clean the transparent film with fingers or cleaners. Never autoclave or perform EOG gas sterilization for the TG-901T3 CO2 sensor kit. It damages the CO2 sensor kit and safety cannot be guaranteed. When using the YG-121T/YG-122T nasal adapter on a patient with bleeding disorder, poor general medical condition or malnutrition, observe the patient condition all the time. The mouth guide touches the mouth and may cause pressure sores. When using the YG-121T nasal adapter on children or patients with low ventilatory amount, the CO2 may mix in the inspiration due to the nasal adapters dead space volume (1.2 mL), resulting in inaccurate measured values or difficulty in detecting apnea. Perform ventilation taking into consideration the 1.2 mL dead space volume. When you use YG-122T together with an oxygen cannula, check that the oxygen cannula is correctly attached on the patient by referring to other parameters and by observing the patient periodically. With the TG-901T3 CO2 sensor kit, secure the CO2 sensor to the respiration circuit so that the transparent film of the airway adapter is perpendicular to the floor. If the transparent film is parallel to the floor, water droplets may get onto the transparent film and affect the measurement accuracy. Failure to follow the instructions below degrades the anti-fogging ability of the transparent film and results in incorrect measurement. - Replace the airway adapter/nasal adapter with a new one every 24 hours. - Replace the airway adapter/nasal adapter with a new one if blood, sputum or mucus adhere to the transparent film. - Do not damage the transparent film. Do not let dust or detergent contact the transparent film. Do not touch, wipe or clean the transparent film with fingers or cleaners. Never autoclave or perform EOG gas sterilization for the TG-901T3 CO2 sensor kit. It damages the CO2 sensor kit and safety cannot be guaranteed. When using the YG-121T/YG-122T nasal adapter on a patient with bleeding disorder, poor general medical condition or malnutrition, observe the patient condition all the time. The mouth guide touches the mouth and may cause pressure sores.
6.3.4
6. MONITORING
TG-901T3 CO2 Sensor kit YG-101T Airway Adapter
TG-101T CO2 sensor
R TE P A

Model Patient Weight Dead space volume Code No.
YG-101T
Adult
10 kg or more
D A
R E P
R LA /A
5 cc
R801
TG-921T3 CO2 Sensor Kit
TG-121T CO2 sensor

R TE AP AD
2
CO
YG-120T YG-121T YG-122T (for nasal breathing) (for naso-oral) (for oxygen cannula)
Nasal tube
HOPER
/A
RM LA
Holder for oxygen cannula
Clip
Mouth guide
Description
Model
Qty
Code No.
Nasal adapter (for nasal breathing) Nasal adapter (for naso-oral breathing) Nasal adapter (for oxygen cannula adjustment)
YG-120T 30 V921 YG-121T 30 V922 YG-122T 30 V923 For over 3 years old or over 10 kg
6.3.5
6. CO2 MONITORING
Preparing for CO2 Monitoring

1. Connect the CO2 sensor kit to the SpO2/CO2 connector on the defibrillator. 2. Connect the CO2 sensor to the respiration circuit. 3. Start measurement and change necessary settings. For handling accessories after use, refer to Section 10.
Connecting the CO2 Sensor Kit to the Defibrillator
Connect the CO2 sensor kit to the SpO2/CO2 connector on the defibrillator.
6.3.6
6. MONITORING
Monitoring CO2
After completing the preparation, CO2 monitoring starts.
CAUTION
When the CO2 sensor not working or CO2 adapter abnormality message is displayed, check the CO2 sensor kit and replace it if necessary. CO2 cannot be monitored while the message is displayed.
NOTE
When using the TG-901T3/TG-921T3 CO2 sensor kit, it performs calibration automatically every minute and when any of the following occurs. - Defibrillator power on - Patients first respiration - Airway adapter is removed from the CO2 sensor and connected again. - Respiration stops for 20 seconds. - Signal changes rapidly due to temperature change. During calibration, the CO2 waveform becomes flat (0 mmHg) but the respiration rate and measured value are not affected.
CO2 Information on the Monitoring Screen
CO2 bar graph Indicates that the upper or lower alarm limit is set to off. 2nd wave setting (Setup screen Date/Screen): SpO2 or OFF Operator's Manual TEC-5500
CO2 value
CO2 waveform Respiration rate
2nd wave setting (Setup screen Date/Screen): CO2, SpO2/CO2 or SpO2/CO2 6.3.7
6. CO2 MONITORING
Changing CO2 Settings

The following settings can be changed for CO2 monitoring.
Item Description (default settings are underlined.)
Scale
Set the scale of CO2 waveform
0 to 40, 0 to 80 (mmHg) 0 to 5.3, 0 to10.7 (kPa) mmHg Upper: 2 to 99, OFF (50) Lower: OFF, 1 to 98 (20) kPa Upper: 1.0 to 13.5, OFF (7.0) Lower: OFF, 0.5 to 13.0 (3.0)
etCO2
Set the upper and lower limit of the CO2 alarm. Set the upper and lower limit of the respiration rate alarm. Set the upper limit of the APNEA alarm.
RR APNEA
Upper: 2 to 150, OFF (OFF) Lower: OFF, 0 to 148 (OFF) Upper: 5 to 40, OFF (OFF)
Changing Settings on the CO2 Setup Screen
2. Select CO2 Setup with the Item or Item key and press the SET key. The CO2 Setup screen appears.
6.3.8
6. MONITORING 3. Press the Item key to select the item. When you press the key, the selected item switches. 4. Press the key for or to change settings. Repeat steps 3 and 4 to set all items. 5. Turn the Energy/Mode select control to the MONITOR position to return to the monitoring screen appears.
Changing the CO2 Scale
Select the appropriate scale for the patient CO2 waveform. Setting range: 0 to 40, 0-80 (default setting) (0 to 5.3, 0-10.7 when kPa is selected) 1. On the CO2 Setup screen, select Scale with the Item key.
2. Select the scale with the or key.
6.3.9
6. CO2 MONITORING
Changing the etCO2 Alarm Limits
Set the upper and lower limit for the etCO2 alarm.
CAUTION
When the upper or lower alarm limit is turned off, there will be no etCO2 upper or lower alarm for that limit.
1. On the CO2 Setup screen, select etCO2 upper or lower limit with the Item key.
The arrow in the etCO2 bar graph indicates the current etCO2 value.
2. Select the upper or lower limit with the or key.
Item
Range
Step
Default setting
Upper mmHg Lower etCO2 Upper kPa Lower
2-99, OFF OFF, 1 to 98 1.0 to 13.5, OFF OFF, 0.5 to 13.0
1 1 0.5 0.5
50 20 7.0 3.0
NOTE
If you increase the upper limit over 99 (mmHg) or 13.5 (kPa), the upper limit becomes OFF. If you decrease the lower limit below 1 (mmHg) or 0.5 (kPa), the lower limit becomes OFF.
6.3.10
6. MONITORING
Changing the Respiration Rate Alarm Limits
Set the upper and lower limit for the respiration rate alarm.
CAUTION
When the upper or lower alarm limit is turned off, there will be no respiration rate upper or lower alarm for that limit.
1. On the CO2 Setup screen, select respiration rate upper or lower limit with the Item key.
The arrow in the RR bar graph indicates the current respiration rate. 2. Select the upper or lower limit with the or key.
Item
Range
Step
Default setting
Upper RR count/min Lower
2 to 150, OFF OFF, 0 to 148
2 2
OFF OFF
NOTE
6.3.11
6. CO2 MONITORING
Changing the APNEA Alarm Limit
Set the period of no respiration for the APNEA alarm. When the defibrillator cannot detect patient respiration for more than the selected seconds, the APNEA alarm occurs.
CAUTION
When the alarm limit is turned off, there will be no APNEA alarm for that limit.
1. On the CO2 Setup screen, select APNEA with the Item key.
2. Select apnea alarm limit with the or key.

APNEA
Upper
5 to 40, OFF
OFF
NOTE
If you increase the upper limit over 40, the upper limit becomes OFF.
6.3.12
6. MONITORING
Inspection of Measuring Accuracy

Daily Inspection of Measuring Accuracy
Perform daily accuracy inspection using your own respiration. Put the larger end of the airway adapter (side for connecting to the patients mask and tracheal tube) into your mouth and after stabilizing breathing, breathe in the same way as in the resting state at a rate of 5 seconds per breath (12 breaths/ minute). Breathing too quickly or taking deep breaths will disable standard measurements. The standard etCO2 concentration is 40 mmHg. Check that the CO2 gas concentration display is from 35 to 45 mmHg.
Inspection of Measuring Accuracy (Precise Method)
Check the measurement accuracy whenever you suspect the defibrillator is not reading correctly. This procedure does not calibrate CO2 sensor. It only checks the measurement accuracy. If the measurement accuracy is not appropriate, contact your Nihon Kohden distributor. The following parts are required.
CAUTION
Only use the specified items. Follow the CAUTION label on the CO2 gas cylinder. After the lifetime of the CO2 gas cylinder expires, the measurement accuracy cannot be guaranteed.
5% CO2 calibration gas Manufacturer: Cylinder name: Outlet connection: Gas volume: Gas component: Accuracy: Expiration:
Nellcor Puritan Bennett or Scott Medical Products OD (1 L disposable cylinder) CGA 600 25 L (Provides about 50 to 100 calibrations) 5% CO2, 21% O2, balance N2 0.03% absolute 3 years after the gas is packed in the cylinder
Flow regulator PR-150 flow regulator (Full scale 700 psi) Manufacturer: VICTOR High Purity & Instrumentation Delivery flow (flow rate): 0.5 L/min Inlet connection: CGA 600 Tube Internal diameter: 4 mm Operator's Manual TEC-5500 6.3.13
6. CO2 MONITORING Slip joint Manufacturer: Specification:
Portex 100/252 4 mm
When using a CO2 gas cylinder and flow regulator other than the above, the following specifications must be met. Make sure that the outlet connection of the gas cylinder and the inlet connection of the flow regulator fit together. 5% CO2 calibration gas Gas component:
Accuracy: Flow regulator Delivery flow (flow rate): 0.5 L/min
5% CO2, 21% O2, balance N2 0.03% absolute
Checking Procedure 1. Connect the flow regulator to the CO2 gas cylinder by rotating the flow regulator clockwise. Connect them firmly.
2. Connect the CO2 sensor kit to the SpO2/CO2 connector on the defibrillator.
3. Connect the airway adapter to the CO2 sensor so that the airway adapter and CO2 sensor align.
marks on the
Pressure gauge
4. After checking that the CO2 gas cylinder is connected properly, gently turn the knob of the flow regulator counterclockwise about half a turn to start the gas flow.
Knob
Pressure gauge Knob Slip joint
5. Connect the slip joint to the airway adapter. CO2 gas flows in the airway adapter and the instCO2 on the screen should read 38 mmHg. (Expiration phase, 38 mmHg CO2 gas) 6. Disconnect the slip joint from the airway adapter and shake the CO2 sensor to remove CO2 gas from the airway adapter. Open air flows into the airway adapter and instCO2 on the screen should be 0 mmHg. (Inspiration phase, no CO2 gas)
Connect/ disconnect the airway adapter repeatedly.
6.3.14
6. MONITORING
CAUTION
This method assumes that no CO2 gas is present in the inspiration phase of breathing. Therefore, step 6 has to be performed to simulate the inspiration phase of breathing so that the defibrillator can correctly determine the CO2 concentration. The defibrillator determines the CO2 concentration by comparing the change in CO2 concentration in the airway adapter during the inspiration and expiration phase of breathing. The defibrillator calculates the CO2 concentration by assuming that the gas temperature is 37C and the surrounding pressure is 1 atmospheric pressure. Therefore, if this checking procedure is performed at room temperature or lower, the defibrillator will display higher instCO2 (there will be 0.4% per C difference). Correspondingly, if the checking procedure is performed at high altitude, the defibrillator will display a lower instCO2 reading (there will be 1 mmHg/30 hPa difference).
7. Repeat steps 5 and 6 a few times and compare the readings of step 5. The readings should be the same. 8. After checking, gently turn the flow regulator knob clockwise to stop the gas flow.
NOTE
When the pressure gauge of the flow regulator reads 0, replace the CO2 gas cylinder with a new one.
6.3.15
6. CO2 MONITORING
6.3.16
Section 7 Alarm Function
General .............................................................................................................................. 7.1 Alarm Types ............................................................................................................. 7.1 Alarm Indication ....................................................................................................... 7.1 Alarm List ................................................................................................................. 7.2 Alarm Status Marks and Messages ......................................................................... 7.4 Temporarily Silencing an Alarm After It Occurs ................................................................. 7.5 Silencing Alarms ...................................................................................................... 7.5 Resuming Alarms .................................................................................................... 7.5 Suspending an Alarm Before It Occurs .............................................................................. 7.6 Suspending Alarms ................................................................................................. 7.6 Automatic Alarm Recording ............................................................................................... 7.6 Setting Alarms ................................................................................................................... 7.7 Alarm Setting Range ................................................................................................ 7.7 Setting Alarm Settings on the Alarm Setup Screen ................................................. 7.8 Setting Alarm Settings on the Alarm Setup Screen of the Setup Screen ................ 7.9 Setting Alarms Individually ..................................................................................... 7.10
7C.1
7C.2
7. ALARM FUNCTION
General
Alarms let you know abnormalities of measurement environment, instrument and measurement value of each parameter by messages on the screen and sound.
Alarm Types
Alarms are categorized into three types.

Alarm Description
Instrument alarm
Generated when any instrument abnormality is detected. (for example, discharged battery or out of recording paper) Generated when any abnormality is detected in measurement environment. (for example, connector off, check electrode, check probe, etc) Generated when each measurement value exceeds previously set upper/lower limits.
Alarm for measurement environment Vital alarm
Alarm Indication
When an alarm occurs, An alarm sounds. An alarm message appears on the screen. For a vital alarm, the measurement value is highlighted. Automatic alarm recording starts. (only for vital alarms and only when the alarm recording is set to ON.) You can turn the alarm recording ON/OFF on the System Setup - Configuration screen. Refer to Section 3.
7.1
7. ALARM FUNCTION
Alarm List
Type
Alarm
Alarm Display
Alarm Sound
SpO2 probe not working SpO2 module not working CO2 adapter abnormality CO2 sensor not working CO2 module not working Overheating High voltage monitor error Relay drive error Insert battery Instrument Alarm (1) Power abnormality Charge battery (blinking Replace battery FET error ERROR K ERROR P ERROR D ERROR C ERROR A Set energy to 50J or less Continuous or beeping tone*
0
Displayed during detection
Continuous tone
Type
Alarm
Alarm Display
Alarm Sound
Battery discharged (battery remaining charge is 1/3 Charge battery (

1 3
Displayed during detection
Continuous or beeping tone*
INTERNAL DISCHARGE Instrument Alarm (2) Out of paper No report data Low impedance High impedance Time to replace battery Displayed during detection No alarm sound Displayed for 5 seconds For 5 seconds
7.2
7. ALARM FUNCTION
Type
Alarm
Alarm Display
Alarm Sound
Pacing stopped (paddle disconnected)** Pacing stopped (ECG lead disconnected) ** Change disposable pads Check disposable pads Connect paddle Use disposable pads Select ECG lead Select a different lead Alarms for measurement environment Change ECG electrodes Check ECG electrodes SpO2 measurement unstable Searching for SpO2 pulse Check SpO2 probe site Check SpO2 unit SpO2 module disconnected** CO2 module disconnected** Connect AC power or Charge battery Displayed during detection Displayed for 5 seconds Displayed during detection
Continuous tone
For 5 seconds
Continuous tone
Type
Alarm
Alarm Display
Alarm Sound
HR alarm PR alarm SpO2 alarm Vital alarm etCO2 alarm RR alarm VF/VT alarm (Check Patient) APNEA Displayed during detection Highlighted value Continuous or beeping tone
You can select either continuous or beeping sound on the System Setup screen. Continuous: continuous beeping Beeping (default setting): sounds for 3 seconds every 30 seconds ** You can silence alarm sound by pressing the Silence alarms key.
7. 3
7. ALARM FUNCTION
Alarm Status Marks and Messages
Alarm off mark: Displayed at every parameter for which the upper and/or lower alarm limit is set to OFF. Displayed at a parameter whose alarm is silenced. Displayed at every parameter when all alarms are suspended. Value: Highlighted while the value exceeds the alarm limit. Alarm off message: Displayed at the top of the screen when any vital alarm upper/lower limit is set to OFF. When the Alarm silenced 2 min, Alarm silenced 1 min, Alarms suspended 2 min or Alarms suspended 1 min message is displayed, the Alarm off message is not displayed. When the alarm silence or suspension finishes, it is displayed again. Disappears when all alarm settings are set to settings other than OFF. VF/VT alarm off mark:
Displayed at the upper right corner of the screen. Displayed when VF/VT analysis is not performed. Displayed when VF/VT Alarm is set to OFF in Alarm Setup screen. Displayed when the paddle lead is selected and the external paddles or internal paddles is connected. Displayed when the Setup screen, pacing screen, Basic checks screen or Alarm Setup screen is selected.
7.4
7. ALARM FUNCTION
Temporarily Silencing an Alarm After It Occurs

When an alarm occurs, you can silence the alarm sound for two minutes.
NOTE
* Instrument Alarm (1) on the page 7.2 Alarms which indicate instrument abnormalities* are not silenced by pressing the Silence alarms key. When the following alarms occur, contact your Nihon Kohden distributor or representative.
SpO2 probe not working SpO2 module not working CO2 adapter abnormality CO2 sensor not working CO2 module not working Overheating High voltage monitor error Relay drive error Power abnormality FET error ERROR K ERROR P ERROR D ERROR C ERROR A
When the following alarms occur, take a remedial action immediately, referring to section 9.
Insert battery Charge battery (blinking Replace battery
0
mark)
During alarm silence, the alarm sound is silenced the Alarm silenced 2 min Alarm silenced 1 min message is displayed at the top of the screen.
When the alarm cause is removed during alarm silence, the alarm is cleared.
Silencing Alarms
Press the Silence alarms key on the front panel.
Resuming Alarms
Alarms resume when: The cause of alarm continues after the alarm silence ends. The Silence alarms key is pressed during alarm silence. A different alarm (except for instrument alarm (2)) occurs. The cause of alarm disappears during alarm silence, then the same alarm occurs again.
7.5
7. ALARM FUNCTION
Suspending an Alarm Before It Occurs

An alarm can also be suspended before it occurs, for example, before you replace the electrodes. The alarm suspend time is two minutes. During alarm suspension, all alarms are suspended and the alarm sound is silenced. The Alarms suspended 2 min or Alarms suspended 1 min message is displayed.
Suspending Alarms
Press the Silence alarms key on the front panel when no alarms are occurring.
WARNING
During alarm suspension (Alarm off or Alarms suspended message displayed), all current alarms except for instrument alarm group 1 are turned off.
Automatic Alarm Recording

When automatic alarm recording is set to ON, waveforms beginning 4 seconds before and ending 8 seconds after the alarm are automatically recorded when an alarm is generated. For details, refer to Section 8.
7.6
7. ALARM FUNCTION
Setting Alarms
Vital alarm limits can be set in three different ways: Set on the Alarm Setup screen while monitoring Set on the Alarm Setup screen of Setup screen Set on each setting screen for the individual parameter of the Setup screen. When you change an alarm setting on one screen, the same setting on another screen is also automatically changed.
CAUTION
When the alarm limit is set to OFF, there will be no alarm for that limit. Be careful when you set the alarm limit to OFF.
Alarm Setting Range
NOTE
If you try to set a value higher than maximum value or lower than minimum value, the alarm becomes OFF. For example, HR upper/lower limit Upper: 290 295 300 OFF Lower: 25 20 15 OFF
Upper HR (heart rate) beat/min Lower Upper PR beat/min Lower Upper SpO2 % Lower Upper mmHg Lower etCO2 Upper kPa Lower Upper RR count/min Lower APNEA s Upper
20 to 300, OFF OFF, 15 to 295 20 to 300, OFF OFF, 15 to 295 51 to 100, OFF OFF, 50 to 99 2 to 99, OFF OFF, 1 to 98 1.0 to 13.5, OFF OFF, 0.5 to 13.0 2 to 150, OFF OFF, 0 to 148 5 to 40, OFF
5 5 5 5 1 1 1 1 0.5 0.5 2 2 5
140 40 140 40 OFF 90 50 20 7.0 3.0 OFF OFF OFF
7.7
7. ALARM FUNCTION
Setting Alarm Settings on the Alarm Setup Screen
NOTE
You can change alarm settings on the Alarm Setup screen only in the MONITOR mode. All vital alarms can be set on one screen. This way is useful when you are monitoring a patient and you want to change or confirm the vital alarm settings. 1. Press the Multi-function key (Alarm Setup) on the front panel to display the Alarm Setup screen.
2. Press the Item key to select the parameter. The left side is upper limits and right side is lower limits. When the key is pressed and held, selected items switch automatically.
3. Press the or key to set the upper and/or lower limit for the selected parameter. When the key is pressed and held, the value increases or decreases automatically.
NOTE
If you try to set a value higher than the maximum value or lower than the minimum value, the alarm becomes OFF. If you try to set the lower limit to a value higher than the upper limit, the higher limit automatically increases. If you try to set the higher limit to a value lower than the lower limit, the lower limit automatically decreases. The increased upper limit or decreased lower limit does not become OFF. 4. Press the Monitor key to return to the monitoring screen. 7.8 Operator's Manual TEC-5500
7. ALARM FUNCTION
Setting Alarm Settings on the Alarm Setup Screen of the Setup Screen
All vital alarms can be set on one screen. 1. Turn the Energy/Mode Select control to the SETUP position. The Setup Menu screen appears.
2. Select Alarm Setup with the Item or Item key and press the SET key. The Alarm Setup screen appears.
3. Press the Item key to select the parameter. When the key is pressed and held, selected items switch automatically. 4. Press the or key to set the upper and/or lower limit for the selected parameter. When the key is pressed and held, the value increases or decreases automatically.
NOTE
If you try to set a value higher than the maximum value or lower than the minimum value, the alarm becomes OFF. If you try to set the lower limit to a value higher than the upper limit, the higher limit automatically increases. If you try to set the higher limit to a value lower than the lower limit, the lower limit automatically decreases. The increased upper limit or decreased lower limit does not become OFF. 5. Turn the Energy/Mode Select control to the MONITOR position.
7.9
7. ALARM FUNCTION
Setting Alarms Individually
You can set each vital alarm on each parameter setup screen. Example: Setting the ECG alarm 1. Turn the Energy/Mode Select control to the SETUP position. The Setup Menu screen appears.
2. Select ECG Setup with the Item or Item key and press SET key. The ECG Setup screen appears. 3. Select HR with the Item key. When the key is pressed and held, selected items switch automatically.
4. Select the heart rate upper and/or lower limit with the or key. When the key is pressed and held, the value increases or decreases automatically.
NOTE
If you try to set a value higher than the maximum value or lower than the minimum value, the alarm becomes OFF. If you try to set the lower limit to a value higher than the upper limit, the higher limit automatically increases. If you try to set the higher limit to a value lower than the lower limit, the lower limit automatically decreases. The increased upper limit or decreased lower limit does not become OFF. 5. Turn the Energy/Mode Select control to the MONITOR position. 7.10 Operator's Manual TEC-5500
Section 8 Recording
About Recording ................................................................................................................ 8.1 Changing Report and Recorder Settings ........................................................................... 8.3 Manual Recording .............................................................................................................. 8.4 Real Time or Delayed Waveform Recording ............................................................ 8.4 Procedure ...................................................................................................... 8.4 Report Recording .................................................................................................... 8.5 Periodic List Report Recording ...................................................................... 8.5 Alarm Report Recording ................................................................................ 8.5 Event List Report Recording .......................................................................... 8.6 Defibrillation Report Recording ...................................................................... 8.8 VF Analysis Report Recording ...................................................................... 8.9 Trend Report Recording .............................................................................. 8.10 Event Recording ...................................................................................................... 8.11 Saving the Administered Medication ....................................................................... 8.12 Automatic Recording ......................................................................................................... 8.13 Record On Charging After Discharge ....................................................................... 8.13 Alarm Recording ...................................................................................................... 8.14 Periodic Recording .................................................................................................. 8.15 Printed Letters and Marks ................................................................................................. 8.16
8C.1
8C.2
8. RECORDING
About Recording
Available recording types are shown on the next page.
NOTE
When the screen changes to any setup screen during recording, recording automatically stops. Record again after you exit the setup screen. For the recording examples in this section, Printing character size is set to Small in the System Setup - Configuration screen.
8.1
8. RECORDING
Recording mode
Recorded data
Length/Capacity of recorded data
Start/Stop Operation
(Real time or delayed) Waveform recording
Periodic List
Waveform on the screen Either real time or 4 seconds delayed waveform recording can be selected. (Delayed is the default setting.) Periodic measurement data
Continuous
Press the Record key. To stop during recording, press the Record key.
Alarm
ECG waveforms and another parameter waveform when an alarm occurs or the Event key is pressed. Event list Waveform at discharge and settings
Manual recording
Report recording
Event list Defib
VF Analysis
Trend
Waveforms of 6 seconds after the CHARGE/AED button is pressed and the analysis result Trend graph and numeric data
Up to 120 measurement data The periodic measurement interval can be selected on the Recorder Setup screen. Waveforms for up to 60 alarms* (when ECG is selected at RecWave on the Recorder Setup screen.) Up to 130 events Up to 44 discharges* Waveform from 10 seconds before to 12 seconds after discharge Up to 124 analyses*
Press the Record key when the Report Setup screen is displayed. To stop during recording, press the Record key.
Event recording**
ECG waveform when the Event key is pressed.
Record on charging after discharge***
ECG waveform before and after discharge
1, 2, 4, 8 or 24 hours. You can set the recorded period at Trend Time on the Report Setup screen. Waveform from 4 seconds before to 8 seconds after the Event key is pressed. ECG from the start of energy charging to 6 or 12 seconds after discharge
Automatic recording
Alarm recording**
ECG waveform when an alarm occurs
Periodic recording
Periodic ECG, SpO2 and CO2 delayed waveforms
ECG waveform from 4 seconds before to 8 seconds after alarm occurrence. For 12 seconds The recording interval is set at PeriodicRec on the Recorder Setup screen.
Press the Event key. To stop during recording, press the Record key. Starts when the defibrillator starts charging energy. To stop during recording, press the Record key. Starts automatically. To stop recording, press the Record key. Starts automatically. To stop recording, press the Record key.
The Alarm, Defib and VF Analysis reports share memory. The length/capacity of recorded data is shown for one report type when no data for the other two report types is saved in memory. If data of more than one report types is saved in memory, the maximum length/capacity of recorded data for each report type decreases. ** This data is used for Alarm report recording. *** This data is used for Defib report recording.
8.2
8. RECORDING
Changing Report and Recorder Settings

1. Turn the Energy/Mode Select control to the SETUP position to display the Setup Menu screen. 2. Select Report Setup or Recorder Setup with the Item or Item key and press the SET key. The Report Setup screen or Recorder Setup screen appears.
Report Setup screen 3. Select the item with the Item key.
Recorder Setup screen
Report Setup screen Report: Select the type of report recording from Periodic list, Alarm, Event list, Defib, VF analysis and Trend. Trend Time: Select the time length to be recorded in the Trend report from 1, 2, 4, 8 and 24 hours. List Interval: Select the measurement interval for Periodic List report from 1, 5, 15, 30 and 60 min. Delete Report?: Select Yes to delete all report data saved in the defibrillator. When Yes is selected, further confirmation keys appear. Press the key for Delete to delete all report data. Recorder Setup screen PeriodicRec: Select the recording interval for the automatic periodic recording from OFF, FREE, 15 min, 30 min, 60 min and 2 hrs. When FREE is selected, recording is performed at the interval set on the Periodic recording interval (min) on the System Setup - Configuration screen. RecWave Select the parameter(s) which is recorded in Waveform recording, Alarm report recording, Event recording, Record on charging after discharge, Alarm recording and Periodic recording from ECG, ECG + SpO2 and ECG + CO2. 4. Select the setting value with the or key. 5. Press the Menu key to return to the Setup - Menu screen. Operator's Manual TEC-5500 8.3
8. RECORDING
Manual Recording
Real Time or Delayed Waveform Recording
The ECG waveforms can be manually recorded at any time. You can record any length waveform with this mode. Besides ECG waveforms, ID, date, time, ECG lead and ECG sensitivity are also recorded. ECG waveform recordings are either real time or delayed; you can select this on the System Setup - Configuration screen. When Delayed recording is set to ON, the waveform from 4 seconds before the Record key is pressed is recorded. Procedure To start recorfding, press the Record key. During recording, the Recording mark appears on the screen. To stop recording, press the Record key again.
Recording example Delayed waveform recording CO2 and SpO2 are measured. MONITOR mode
Time constant 0.32s AC filter is ON ECG lead II Paper speed 25mm/s SpO2 sensitivity 1 ECG sensitivity 1
8.4
8. RECORDING
Report Recording
There are six kinds of report recording: Periodic list, Alarm, Event list, Defib, VF analysis and Trend. To do report recording, you need to display the Report Setup screen. Set the following settings on the Report Setup screen. Periodic List Report Recording Measurement values for each parameter at the selected interval are recorded in a list format. Procedure 1. Select Periodic list at the Report on the Report Setup screen. Refer to Changing Report and Recorder Settings in this section. 2. Press the Record key. The Report recording mark appears on the screen. The recording stops when all data are recorded. To stop recording, press the Record key again. You can select the measurement interval at List Interval on the Report Setup screen. The data for the Periodic list report recording remains in memory after the power off.
Alarm Report Recording ECG waveform and either SpO2 or CO2 waveform when the Event key is pressed or when an alarm occurs is recorded. The recorded data are the same as that of the Event recording and automatic alarm recording. Procedure 1. Select Alarm at the Report on the Report Setup screen. Refer to Changing Report and Recorder Settings in this section. 2. Press the Record key. The Report recording mark appears on the screen. The recording stops when all data are recorded. To stop during recording, press the Record key again. The data for the Alarm report recording remains in memory after the power off. Waveforms for up to 60 alarms are saved when ECG is selected at RecWave on the Recorder Setup screen. After waveforms for 60 alarms are saved, when another alarm occurs, the waveform for that alarm is saved and the oldest 15 waveforms are deleted. Waveforms for up to 48 alarms are saved when ECG and SpO2 are selected at RecWave on the Recorder Setup screen. After waveforms for 48 alarms are saved, when another alarm occurs, the waveform for that alarm is saved and the oldest 12 waveforms are deleted. Waveforms for up to 56 alarms are saved when ECG and CO2 are selected at RecWave on the Recorder Setup screen. After waveforms for 56 alarms are saved, when another alarm occurs, the waveform for that alarm is saved and the oldest 14 waveforms are deleted. Operator's Manual TEC-5500 8.5
8. RECORDING Recording examples (1) When the Event key is pressed
(2) When an alarm occurs
Event List Report Recording The list of defibrillator usage history with clock time are recorded in a chronological order. This is useful for an operation diary or defibrillator operation history. Procedure 1. Select Event list at the Report on the Report Setup screen. Refer to Changing Report and Recorder Settings in this section. 2. Press the Record key. The Report recording mark appears on the screen. The recording stops when all data are recorded. To stop during recording, press the Record key again. The data for the Event list report recording remains in memory after the power is turned off. Recording example
Up to 10 events are recorded on one column. Up to 130 events are recorded. After 130 event data are saved, when the defibrillator detects another event, the oldest data is deleted. 8.6 Operator's Manual TEC-5500
8. RECORDING Recorded Events
Event
Meaning
Power ON Power OFF Charging Charged Discharge XXX J Sync XXX J VF analysis start Shockable No Shockable Check Patient Disarm Alarm HR *XXX Alarm PR *XXX Alarm SpO2 *XXX Alarm RR *XXX Alarm etCO2 *XXX mmHg Alarm etCO2 *XXX kPa Alarm Apnea *XXX s Event ECG electrode off ECG electrode set Dispo pads off Dispo pads set Fixed mode start (XXXppm, XXXmA) Demand mode start (XXXppm, XXXmA) Pacer stop (XXXppm, XXXmA) Alarm suspend SpO2 module off SpO2 module set CO2 module off CO2 module set Adrenalin Atropine Lidocaine Other
The power is turned on. The power is turned off. Charging for discharge is started. Charging for discharge is completed. Defibrillation is performed at XXX J. Synchronized cardioversion is performed at XXX J. CHARGE/AED button is pressed in AED mode. The defibrillator detected a shockable rhythm after the CHARGE/AED button was pressed in AED mode. The defibrillator did not detect a shockable rhythm after the CHARGE/AED button was pressed in AED mode. The defibrillator detects a shockable rhythm. The energy discharges internally within 20 seconds after charging. Heart rate alarm occurs at XXX bpm. Pulse rate alarm occurs at XXX. SpO2 alarm occurs at XXX. Respiration rate alarm occurs at XXX. etCO2 alarm occurs at XXX mmHg. etCO2 alarm occurs at XXX kPa. Apnea alarm occurs at XXX seconds. The Event key is pressed. A disposable electrode is detached from the patient. A disposable electrode is attached to the patient. The pad adaptor is disconnected from the defibrillator, or the disposable pad is detached from the patient. The pad adaptor is connected to the defibrillator, or the disposable pad is attached to the patient. The Fixed pacing mode (pacing rate XXX pulse/min and pacing current is XXX mA) is started. The Demand pacing mode (pacing rate XXX pulse/min and pacing current is XXX mA) is started. Pacing (pacing rate XXX pulse/min and pacing current is XXX mA) is stopped. The alarm is silenced or suspended. The SpO2 module is disconnected from the defibrillator. The SpO2 module is connected to the defibrillator. The CO2 sensor kit is disconnected from the defibrillator. The CO2 sensor kit is connected to the defibrillator. The Medication key - Adrenalin is pressed. The Medication key - Atropine is pressed. The Medication key - Lidocaine is pressed. The Medication key - Other is pressed.
8.7
8. RECORDING Defibrillation Report Recording Waveform at defibrillation and cardioversion and discharge information are recorded. Procedure 1. Select Defib in Report on the Report Setup screen. Refer to Changing Report and Recorder Settings in this section. Report recording mark appears on the screen. The 2. Press the Record key. The recording stops when all data are recorded. To stop during recording, press the Record key again, The data for the Defibrillation report recording remains in memory after the power off. Recording example
Compressed ECG waveform is recorded in three rows. The amplitude of the recorded waveform is 1/2 of the waveform on the screen (on screen: 10 mm/1mV 5 mm/1mV) Waveform of 22 seconds (10 seconds before and 12 seconds after discharge) and setting at the discharge are recorded for one discharge. Up to 44 discharges are recorded. After 44 data are saved, when the defibrillator detects another discharge, the data for that discharge is saved and the oldest 11 data (both waveform and setting at discharge) are deleted. When another discharge is performed within 22 seconds after previous discharge, the recording is extended for 12 seconds after the second discharge and is counted as one recording. In this case, maximum recordable discharge is less than 44. Up to 6 discharge marks are recorded on one waveform. Discharge information Date: Date when defibrillation or cardioversion is performed. Time: Clock time when defibrillation or cardioversion is performed. Set Energy: Selected energy value TTR: Skin-paddle (pad) contact impedance Delivered: Output energy value. When TTR is 15 or less, or 255 or more, 0 J is printed. Shock Times: Total counts after the defibrillator power is turned on. Manual: Defibrillation (Manual Sync is for Synchronized cardioversion and AED is for AED) TEST: Printed only when energy discharge test is performed. OK: Test OK NG: Test NG 8.8 Operator's Manual TEC-5500
8. RECORDING VF Analysis Report Recording Waveforms of 6 seconds after the CHARGE/AED button is pressed and the analysis result are recorded. Procedure 1. Select VF Analysis in Report on the Report Setup screen. Refer to Changing Report and Recorder Settings in this section. Report recording mark appears on the screen. 2. Press the Record key. The The recording stops when all data are recorded. To stop during recording, press the Record key again. The data of the VF Analysis report recording remains in memory when the defibrillator power is turned off. Waveforms for up to 124 VF analyses are saved. After 124 waveforms are saved, when the defibrillator performs another VF analysis, the waveform for that VF analysis is saved and the oldest 31 data are deleted. Recording examples
8.9
8. RECORDING Trend Report Recording The trend graph and numeric data of heart rate, SpO2 , PR, etCO2 and RR which are saved in memory are recorded. Procedure 1. Select Trend in Report on the Report Setup screen. Refer to Changing Report and Recorder Settings in this section. 2. Press the Record key. The Report recording mark appears on the screen. The recording stops when all data are recorded. To stop during recording, press the Record key again. The data of the Trend report recording remains in memory when the defibrillator power is turned off. You can select recorded trend time from 1, 2, 4, 8, 24 hours at Trend period on the Report Setup screen. The relation between recorded trend time and interval of data acquisition is shown below.
Trend time (hours) Data acquisition interval (minutes) 1 1 2 2 4 4 8 8 24 24
The maximum, minimum and average value in each data acquisition interval is recorded. The vertical axis scale changes according to the recorded data so that all data can be recorded on the paper. Recording examples (1) Heart rate and SpO2
(1) Pulse rate and etCO2
8.10
8. RECORDING (3) Respiration rate
Event Recording
ECG waveform from 4 seconds before to 8 seconds after the Event key is pressed is recorded. Recording mark appears on the screen and When an alarm occurs, the automatic alarm recording starts. The waveform from 4 seconds before to 12 seconds after the alarm occurrence is recorded. When energy charging starts, the Recording mark appears on the screen and record on charging after discharge starts instead of event recording. If there is no paper in the recorder when the Event key is pressed, ECG waveform at the time is saved as the data for alarm report recording.
Recording example
8.11
8. RECORDING
Saving the Administered Medication
When Medication on the System Setup - Configuration screen is set to ON (Default setting: OFF), the administered medication (adrenalin, atropine, lidocaine and other) can be saved and recorded as the event list report and alarm report with the 12 seconds of ECG waveforms. 1. Set Medication on the System Setup - Configuration screen to ON. Refer to System Setup Screen in Section 3. 2. Press the Event key. The Event recording starts. The function keys change to Adrenalin, Atropine, Lidocaine and Other function keys.
3. Press the key for the administered medication. The function keys return to the normal function keys 5 seconds after the Event key is pressed. 4.. Set Medication on the System Setup - Configuration screen to OFF. Medications are not saved as sound data. During alam recording, if two or more medication keys are pressed, only the latest medication is saved as the event report and alarm report.
8.12
8. RECORDING
Automatic Recording
Record On Charging After Discharge NOTE
To perform record on charging after discharge, set Record on charging after discharge to ON on the System Setup-Configuration screen before using the defibrillator. The recording starts automatically when energy charging starts. During automatic recording, the Recording mark appears on the screen. ECG waveform from the start of charging to 12 or 6 seconds after discharge is recorded. When the energy is externally discharged, information of the discharge is also recorded. To stop during recording, press the Record key. If energy is not discharged within 40 seconds after charging is completed, recording automatically stops. If the defibrillator starts charging while Event recording or another automatic recording is being performed, record on charging after discharge starts instead. If another defibrillation or cardioversion is performed while record on charging after discharge is being performed, recording is extended for 12 seconds after the second defibrillation or cardioversion is performed.
Recording example
8.13
8. RECORDING
Alarm Recording
NOTE
To perform automatic alarm recording, set Alarm recording to ON on the System Setup Configuration screen before using the defibrillator. Recording starts at the alarm occurrence. During alarm recording, the Recording mark appears on the screen. The ECG waveform from 4 seconds before to 8 seconds after the alarm occurrence is recorded. The waveform is saved for the data of alarm report recording. When an alarm occurs during another recording, the currently performed recording has priority. When energy charging starts during automatic alarm recording, record on charging after discharge starts instead of automatic alarm recording. (Only when Record on charging after discharge is set to ON (6s) or ON (12s) on the System Setup-Configuration screen before using the defibrillator.)
Recording example
8.14
8. RECORDING
Periodic Recording
Recording automatically starts at a preset interval. 12 seconds of the waveform(s) selected at RecWave on the Recorder Setup screen is recorded. Besides ECG waveforms, ID, date, time, ECG lead and ECG sensitivity are also recorded. Only delayed ECG waveform is recorded. For recording interval, Select either 15 min, 30 min, 60 min, 2hr or FREE at PeriodicRec on the Recorder Setup screen. When OFF is selected, automatic periodic recording is not performed. When FREE is selected, recording is performed at the interval set on the Periodic recording interval (min) on the System Setup - Configuration screen.
Recording example
8.15
8. RECORDING
Printed Letters and Marks
Item
Printed letters
Description
Recording type
Event Report Defib Report Trend Report List Report Alarm Report VF Report
Event report recording Defibrillation report recording Trend report recording List report recording Alarm report recording VF analysis report recording Real time waveform recording Delayed waveform recording Monitoring mode Manual defibrillation mode AED mode Fixed Pacing mode Demand Pacing Mode Year/Month/Day Month/Day/Year Year/Month/Day Day/Month/Year Hour:Minute:Second
Real time/Delayed recording* Operation mode
Real Delay Mon Manual Defib AED Fix Pace Demand Pace
Date*
YYYY/MM/DD MMM/DD/YYYY YYYY/MMM/DD DD/MM/YYYY
Clock time *
2 1
XX:XX:XX ID: XXXXX
Instrument ID * ECG sensitivity Paper speed * ECG lead

1
1/4, 1/2, 1, 2, 4, AUTO1/4, AUTO1/2, AUTO1, AUTO2, AUTO4 50 mm/s 25 mm/s PADDLE, I, II, III, aVR, aVL, aVF, V, AUX, TEST
2
SpO2 sensitivity * CO2 scale * , * AC filter *

2 1 2
SpO2: 8, 4, 2, 1, 1/2, 1/4, 1/8, AUTO 0-40 mmHg, 0-80 mmHg, 0-5.3kPa, 0-10.7kPa AC Filter: ON AC Filter: OFF AC filter ON AC filter OFF 0.32 second 3.2 second
Time constant * Heart rate * SpO2 *

3 3 3
T.C.: 0.32s T.C.: 3.2 s HR: XX SpO2: XX% PR: XX

3
Pulse rate * etCO2 *

3
Respiration rate *
RR: XX etCO2: XX mmHg, XX kPa Set: XXX J Shock Times: XX TTR: XXX ohm Delivered: XXX J
The point of discharge Selected energy Shock times TTR Delivered energy
8.16
8. RECORDING
Item Printed letters Description
Test discharge result Synchronization/non synchronization Synchronization point Pacing rate Pacing intensity The point of pacing pulse output The point of event occurrence The point of implanted pacemaker pulse output
Test: OK Test: NG Sync/no display XX ppm XX mA P E
Test discharge was performed normally. Test discharge failed.
Medication
Adrenalin Atropine Lidocaine Other
Adrenalin was administered. Atropine was administered. Lidocaine was administered. Other medication was administered.
*1 The format can be set at System Setup screen. *2 Can be set on the setup screen. Refer to Section 3. *3 When an alarm occurs, the * mark is displayed before each value. (Example: HR:*200).
8.17
8. RECORDING
8.18
Section 9 Messages and Troubleshooting

Messages ............................................................................................................................ 9.2 Troubleshooting ................................................................................................................. 9.10 General .................................................................................................................... 9.10 Defibrillation ............................................................................................................. 9.11 Pacing (TEC-5531 Series Only) ............................................................................... 9.11 Monitoring ............................................................................................................... 9.12 ECG .............................................................................................................. 9.12 SpO2 ............................................................................................................................................................................................... 9.13 CO2 ................................................................................................................................................................................................... 9.14 Recording ................................................................................................................ 9.15 Battery .................................................................................................................... 9.16 SD Card .................................................................................................................. 9.16
9C.1
9C.2
9. MESSAGES AND TROUBLESHOOTING
When trouble occurs, take quick action referring to the table below. If there is any damage or the defibrillator or its peripheral component is suspected to be faulty, turn the power off, attach a Unusable or Repair request label and contact your Nihon Kohden distributor or representative.
9.1
Messages
Message
Description
Action
AED Alarm off Alarm silenced 1 min Alarm silenced 2 min Alarms suspended Alarms suspended 1 min Alarms suspended 2 min
AED mode is selected. One or more alarms for parameters available for measurement is set to OFF. Alarm is silenced for 1 minute. Alarm is silenced for 2 minutes. All alarms are suspended. This message is displayed only during basic checks. Remaining time of alarm suspension is 1 minute. When no alarm is occurring and the SILENCE ALARMS key is pressed, this message is displayed. Remaining time of alarm suspension is 2 minutes. The defibrillator is performing VF/VT analysis. Respiration was not detected for the period set on the Alarm screen. Basic checks are complete. Basic checks are normally complete. Very little battery charge remains. During battery test The battery was not fully charged 5 hours after battery charging started.
-------------
---
Analyzing VF APNEA Basic checks complete Basic checks OK Battery discharged Battery charge timed out
-------------
Battery charging error Battery discharge timed out
During battery test An error occurred in battery charging During battery test The voltage did not decrease to the specified level 3 hours after battery discharging started. Appears when battery test finishes. (when charging for the next use is complete) Battery test result is 70 to 100% Battery test result is 50 to 69%.
---
---
Battery test complete Battery OK Battery WEAK
-------
9.2
Message
Description
Action
Cannot use card
A card other than specified ones is inserted. A card for version upgrade is inserted on the Save Report screen. -------------------
Capacitor test fail Capacitor test pass Change disposable pads Change ECG electrodes Change to monitor mode CHARGED Charge battery CHARGING
Capacitor test failed. Capacitor test result is OK. Deteriorated disposable pads (Abnormal polarization voltage in PADDLE lead) Deteriorated ECG electrodes (Abnormal polarization voltage in ECG leads) The multi-function key was pressed in a mode other than the MONITOR mode In manual or AED mode, high voltage energy charging is complete. There is little battery charge remaining. The 0 mark is displayed. In manual or AED mode, the instrument is adjusting the energy in the capacitor. The defibrillator is charging high voltage energy. During battery test The battery is being charged for the battery test.
Charging battery
---
Check ECG electrodes
An ECG electrode is detached from the patient. ECG connection cable or external ECG cable is disconnected from the ECG connector.
-----
Check disposable pads
In manual or AED mode, the contact impedance of the disposable pads is over 350 . When PADDLE lead is selected, disposable pads are not attached to the patient firmly. The pad adaptor is disconnected from the disposable pads. In FIXED or DEMAND pacing mode, the disposable pad is not firmly attached to the patient.
Clip hair on the skin where pads are placed, Firmly connect the pad adaptor and
disposable pads.
then firmly attach the disposable pads to the patient chest.
Firmly connect the pad adaptor and disposable pads. Firmly attach the disposable pads to the patient chest. ---
Check patient
In background analysis, patient ECG was judged as a shockable rhythm.
9.3
Message
Description
Action
Check pulse
This message appears: After third defibrillation is performed in AED mode When the defibrillator did not detect a shockable rhythm. ---
Check SpO2 probe site
The probe attachment site is not appropriate. The probe lifetime is expired.
Attach the probe at a site indicated in the probe operators manual. Replace the probe with a new one. Check the probe attachment condition and remove the cause. Securely connect the probe to the SpO2 adapter. Replace the probe with a new one. --Replace the battery or use AC power.
Check SpO2 probe
The probe is detached from the patient. The probe is disconnected from the SpO2 adapter. The probe expired.
Checking battery Connect AC Power or Charge Battery Connect external paddles to paddle holders Connect to AC power Connect paddle
During battery test Battery capacity is being checked. In AED mode, the battery is discharged and the energy for the defibrillation cannot be charged. Appears when performing basic checks and the external paddles are not set on the paddle holders. The defibrillator is not connected to AC power during battery test. In FIXED or DEMAND pacing mode, the pad adaptor is not connected to the defibrillator. In manual or AED mode, paddles or disposable pads are not connected to the defibrillator. When PADDLE lead is selected, paddles or disposable pads are not connected to the defibrillator.
--Connect the defibrillator to AC power. Connect the pad adaptor to the defibrillator and then turn the Energy/Mode Select control to FIXED or DEMAND position Connect the paddles or disposable pads to the defibrillator. Connect the paddles or disposable pads to the defibrillator. Refer to the operators manual of the CO2 sensor kit. Replace the CO2 adapter with a new one. Replace the CO2 sensor with a new one. Contact your Nihon Kohden distributor or representative. You can make this message disappear by pressing the Silence alarms key. Connect the CO2 cable to the SpO2/CO2 connector. If the message still appears, contact your Nihon Kohden distributor or representative.
CO2 adapter abnormality
Insufficient light CO2 adapter is faulty or deteriorated.
CO2 sensor not working CO2 module not working CO2 module disconnected
CO2 sensor is faulty or deteriorated. CO2 module is faulty. CO2 cable is disconnected from the defibrillator.
9.4
Message
Description
Action
Defibrillation necessary. Check ECG Defibrillation not necessary. Check ECG. Demand Discharging battery
By VF analysis with the CHARGE/AED button, defibrillation was judged to be necessary. By VF analysis with the CHARGE/AED button, defibrillation was judged to be unnecessary. Demand pacing mode is selected. During battery test The battery is being discharged for battery test.
---
-------
Did the alarm sound? Did the recorder print? Enter password Enter password again ERROR A ERROR C ERROR D ERROR K ERROR P FET error File Error Fixed High impedance High voltage monitor error
The basic checks-Alarm check is being performed. The basic checks-Recorder check is being performed. Password to enter manual mode is required. Entered password is not correct. Faulty HV Communication error Faulty ROM/RAM Faulty keys Faulty pacing unit The circuit to measure remaining battery charge is faulty. Sound data saved in the SD card is damaged. FIXED pacing mode is selected. Skin-paddle contact impedance is too high. Faulty high voltage unit Enter a password.
-----
Enter the correct password. Turn the Energy/Mode Select control to the OFF position. Then turn on the defibrillator and do the same operation that you did when the error message appeared. If the error message still appears, immediately turn off the power and contact your Nihon Kohden distributor or representative. Contact your Nihon Kohden distributor or representative. ----Press the paddles on the patient firmly. Turn the Energy/Mode Select control to the OFF position. Then turn on the defibrillator and do the same operation that you did when the error message appeared. If the error message still appears, immediately turn off the power and contact your Nihon Kohden distributor or representative.
9.5
Message
Description
Action
If no pulse, press CHARGE/AED button
Appears 5 seconds after the confirmation message after CPR is displayed. When not performing CPR, appears 5 seconds after the message confirming pulse.
--------Insert a specified memory card into the defibrillator. --Only one CO2 can be measured. If two CO2 cables are connected, only the first connected CO2 is measured. Disconnect one of the CO2 cables. Only one SpO2 can be measured. If two SpO2 cables are connected, only the first connected SpO2 is measured. Disconnect one of the SpO2 cables. Check that the paddles do not touch each other. ---
If no pulse, start CPR INTERNAL DISCHARGE Insert ATA CARD
When CPR time is set in AED mode, this message appears after third defibrillation. Energy was not discharged to the patient. You tried to save data in a memory card when no card was inserted in the defibrillator. You tried to do the battery test when the battery was not inserted in the defibrillator. A CO2 cable was connected to the left SpO2/CO2 connector when a CO2 cable was already connected to the right SpO2/CO2 connector. A SpO2 cable was connected to the left SpO2/CO2 connector when a SpO2 cable was already connected to the right SpO2/CO2 connector. Skin-paddle contact impedance is too low. Manual defib confirmation is set to confirm and the Energy/Mode select control is turned to the position of defibrillation. You tried to do report recording when there was no data for report recording saved in the defibrillator Very little free memory in the SD card. Pacing is started. Sound is playing back Out of recording paper Recorder door is open. Faulty high voltage unit The defibrillator discharged too frequently and the internal temperature is too high.
Insert battery Left side CO2 not measured
Left side SpO2 not measured
Low impedance Manual defibrillation?
No report data
--------Change the role of recording paper. Press the magazine until it clicks. Turn the Energy/Mode Select control to the OFF position and leave the defibrillator for 20 minutes. Then turn on the defibrillator and check if the message appears again. If it still appears, immediately turn off the power and contact your Nihon Kohden distributor or representative.
Not enough free memory Now pacing Now playing Out of paper Overheating
9.6
Message
Description
Action
Pacing stopped (ECG lead disconnected)
Pacing stopped because: (1) An electrode lead is disconnected from an electrode. (2) An electrode is detached from the patient. (3) Electrode lead is disconnected from the JC-762V connection cable. (4) Bad contact between the electrode and lead clip. (5) Electrode lead discontinuity (6) Abnormally high polarization voltage (1) Firmly connect the electrode lead to the ECG electrode. (2) Replace the electrodes with new ones. (3) Firmly connect the electrode lead to the connection cable. (4) Replace the electrode lead with a new one. (5) Replace the electrode lead with a new one. (6) Replace the electrodes with new ones. (1) Firmly connect the pads to the pad adaptor. Firmly connect the pad adaptor to the paddle connector. (2) Attach the disposable pads to the patient. ---
Pacing stopped (paddle disconnected)
Pacing stopped because: (1) The pad adaptor is disconnected from the disposable pads. (2) The disposable pads are detached from the patient.
Power abnormality Press CHARGE/AED button
Input power voltage is too high.
When the Check Pulse Pattern on the System Setup screen is set to 3 (no checking pulse), in AED mode, this message appears 5 seconds after the Check patient message appears.
Appears as the guidance for capacitor test. Appears in discharge check. Faulty high voltage unit Battery test result is 0 to 49%. The defibrillator judged that the battery should be replaced with a new one. A CO2 cable was connected to the right SpO2/CO2 connector when a CO2 cable was already connected to the left SpO2/CO2 connector. Defibrillator power is turned on when two CO2 cables are connected.
---
Press CHARGE button Press DISCHARGE buttons until discharge Relay drive error Replace battery
----Contact your Nihon Kohden distributor or representative. --Only one CO2 can be measured. If two CO2 cables are connected, only the first connected CO2 is measured. Disconnect one of the CO2 cables.
Right side CO2 not measured
Right side SpO2 not measured
A SpO2 cable was connected to the right SpO2/CO2 connector when a SpO2 cable was already connected to the left SpO2/CO2 connector. Defibrillator power is turned on when two SpO2 cables are connected.
Only one SpO2 can be measured. If two SpO2 cables are connected, only the first connected SpO2 is measured. Disconnect one of the SpO2 cables.
SD: Insert a Card SD: Card Error SD: Ready SD: Accessing
SD card is not inserted. Could not access the SD card. The SD card is ready to use. Accessing the SD card.
Insert the SD card into the SD card slot. -------
9.7
Message
Description
Action
Searching for SpO2 pulse
The instrument is searching for correct pulse waveform. SpO2 value cannot be measured because of unstable pulse waveform. The probe is detached from the patient.
Wait until the pulse waveform is detected.
Check the probe attachment and remove the cause. ---
Select a different lead Select ECG lead
During pacing in DEMAND mode, ECG lead is set to a lead other than ECG leads. Under the setting that does not permit synchronized cardioversion with PADDLE lead, SYNC mode is selected with PADDLE lead. SYNC button is pressed when TEST lead is selected. TEST lead is selected in pacing mode.
---
-------
Select AED or monitor if not manual defibrillation?
When Manual defib confirmation is set to password or confirmation and the Energy/Mode select control is turned to the position of defibrillation. Above 50 J is selected when the internal paddles are connected to the defibrillator. Recording paper is not set in the recorder during basic checks. You tried to perform the HV capacitor test with the energy set to other than 200J. The defibrillator is shutting down now.
NOTE While the Shutdown NOW message is displayed on the screen, do not disconnect the power cord from the defibrillator or AC outlet and do not remove the battery pack from the defibrillator. The internal data may be damaged.
Set energy to 50J or less Set recording paper Set to 200J Shutdown NOW
--Set the paper in the recorder. Set the energy to 200J.
---
SpO2 module disconnected
SpO2 cable is disconnected from the defibrillator. SpO2 measurement is unstable due to patient body movement
Connect the SpO2 to the SpO2/CO2 connector. If the message still appears, contact your Nihon Kohden distributor or representative. If this message appears frequently, check the patient and probe attachment condition. Reattach the probe to the patient if necessary.
The M mark is displayed beside the SpO2 value.
9.8
Message
Description
Action
SpO2 module not working SpO2 probe not working
Faulty SpO2 module The probe lifetime is expired. Probe discontinuity or short-circuit Faulty cable of the SpO2 adapter Faulty SpO2 probe
Contact your Nihon Kohden distributor or representative. Replace the probe with a new one. Replace the probe with a new one. Replace the SpO2 adapter with a new one. Replace the SpO2 probe with a new one. If the message still appears, replace the SpO2 adapter. -----
Stand clear Stand clear and press DISCHARGE buttons
In AED mode, the CHARGE/AED button is pressed and the defibrillator starts VF analysis. In AED mode, charging defibrillation energy is complete. This message appears: When CPR is required After discharge for one sequence When nonshockable rhythm is detected Synchronized cardioversion is selected. Energy was not discharged properly in discharge test. Energy was discharged properly in energy discharge test. The defibrillator is performing the HV capacitor test. More than one year has passed since the key for Reset was pressed. In FIXED or DEMAND pacing mode, disposable pads are not used. In AED mode, disposable pads are not used.
Start CPR
---
SYNC Test fail Test OK Testing. Please wait. Time to replace battery Use disposable pads
----------------Confirm that the voice is heard.
Use another instrument Was the voice heard?
ERROR A appeared in basic checks. The basic checks-voice check is being performed.
9.9
Troubleshooting
General
Problem Possible Cause Action
The instrument heats up.
The instrument is used for many hours. Instrument abnormality
There is no abnormality in the instrument. Turn the Energy/Mode select control to OFF position and disconnect the power cord. Contact your Nihon Kohden distributor or representative. Firmly connect the power cord to the AC outlet and the defibrillator. Install the specified battery. Replace the battery with a new one (NKB-301V). Charge the battery. Contact your Nihon Kohden distributor or representative Contact your Nihon Kohden distributor or representative Replace the backup battery with a new one. For replacement, contact your Nihon Kohden distributor or representative. (Under normal use condition, the backup battery lifetime is about 6 years.) Contact your Nihon Kohden distributor or representative. Deleted data cannot be recovered. Contact your Nihon Kohden distributor or representative. Confirm the AC power cord connection. When the power cord is properly connected and the symptom still appears, contact your Nihon Kohden distributor or representative.
No operation when the instrument is turned on.
The power cord is disconnected. The battery is not installed. Faulty battery Remaining battery charge is low. Instrument abnormality
Screen is dim. Waveform and characters are not seen. The printed date is JAN/01/80.
Instrument abnormality The backup battery is almost discharged.
The report data are not saved.
Faulty internal memory On the Setup screen, the report data were deleted.
All settings set in the Setup screen and System Setup screen return to the default settings. When the battery is installed, the instrument suddenly changes to battery operation. When the battery is not installed, the instrument power suddenly drops. The date and time printed on the recording paper is incorrect.
Faulty internal memory
Power voltage changed.
--The backup battery for the clock is discharged.
Set the date and time on the Date/Screen screen. Refer to Section 3. Contact your Nihon Kohden distributor or representative.
On the screen, there are some pixels which have randomly abnormal color or do not light. No sound is heard.
For the TFT LCD screen, it is considered normal if some pixels have randomly abnormal color or do not light. Voice prompt is set to OFF in the System Setup - Configuration screen Faulty speaker or speaker cable discontinuity
---
Increase the volume. Repair is necessary. Contact your Nihon Kohden distributor or representative.
9.10
Defibrillation
The defibrillator self-discharges the energy during charging.
In battery operation, the battery is almost discharged.
Operate the defibrillator on AC power and recharge the battery. The battery is automatically charged when the defibrillator is connected to AC power. When an error code appears on the screen, use another instrument. The instrument is faulty. Contact your Nihon Kohden distributor or representative. Change to the appropriate lead. On the Paddle Setup screen, set the Sync by paddle lead to ON.
Faulty high voltage unit. (Error code appears on the screen.)
Cannot switch to synchronized mode.
Appropriate lead is not selected. You tried to perform synchronized cardioversion with the PADDLE lead but synchronized cardioversion with the PADDLE lead is set to OFF on the Paddle Setup screen.
0 J is printed on the defibrillation report recording.
TTR is 15 or less TTR is 255 or more.
Check that the paddles do not touch each other. Press the paddles on the patient firmly.
Pacing (TEC-5531 Series Only)

Although the PULSE lamp is lit, pacing pulse does not appear on the ECG. Although the START/STOP key is pressed, pacing does not start.
Pacing pulse is not output. Pacing energy is set to 0 mA. In DEMAND mode, selected pacing rate is slower than the patient heart rate.
Contact your Nihon Kohden distributor or representative. Set the appropriate pacing energy with the PACING OUTPUT Up/Down key. Set the pacing rate appropriate for the patient heart rate. When the patient heart rate is slower than the selected pacing rate, pacing pulse is output automatically. Contact your Nihon Kohden distributor or representative.
Faulty pacing function (system error code appears on the screen)
9.11
Monitoring
ECG
Dotted lines appear instead of the ECG waveforms.
An ECG electrode is detached. An electrode lead is disconnected from the electrode. The ECG connection cable is disconnected from the defibrillator. An electrode lead is faulty.
Remove the cause. If the symptom still appears, change the lead. If the symptom still appears, the instrument is faulty. Contact your Nihon Kohden distributor or representative. Check the patient. On the Setup screen, set the AC hum filter to on. Check if there is AC interference with other instruments, and remove the cause.
Baseline drifting AC interference (50 or 60 Hz sine wave is superimposed on the ECG waveform.)
Patient body movement On the Setup screen, AC hum filter is set to off.
ECG waveform does not appear on the screen although electrodes are connected properly.
Electrode lead discontinuity Dirty electrode New and old or other types of electrodes are used together. QRS Volume is set to 0 in the Setup screen - QRS Setup. QRS Sound is set to SpO2 in the Setup screen - QRS Setup. Faulty speaker or speaker cable discontinuity
Replace the electrodes or leads with new ones. Use the same type electrodes which are purchased together. Increase the volume. Set QRS Sound to ECG. Repair is necessary. Contact your Nihon Kohden distributor or representative. Remove the cause of the noise. On the Setup screen, set the AC hum filter to ON. On the Setup screen, set pacing pulse rejection to OFF. Remove the cause of the noise. Press the Silence alarms key again. On the Setup screen, set the upper/lower limit of each vital alarm. Repair is necessary. Contact your Nihon Kohden distributor or representative.
No sync sound
QRS sync mark is not displayed.
On the Setup screen, pacing pulse rejection is set to ON and large amplitude AC interference noise is on the ECG waveform.
Sync sound is irregular although there is no arrhythmia. No alarm is generated
Noise was misjudged to be QRS. The Silence alarms key is pressed. On the Setup screen, alarm is set to OFF. Faulty speaker
9.12
SpO2
SpO2 value is not displayed on the screen.
The SpO2 adapter cable is disconnected from the SpO2/CO2 connector. The SpO2 probe is disconnected from the SpO2 adapter. Cable discontinuity in SpO2 adapter or probe SpO2 probe attachment to the patient is loose.
Connect the SpO2 adapter to the SpO2/CO2 connector. Firmly connect the probe to the SpO2 adapter. Replace the SpO2 adapter or probe. Firmly attach the probe to the patient. Firmly attach the probe to the patient. Repair is necessary. Contact your Nihon Kohden distributor or representative. Connect the probe to the SpO2 adapter. Connect the SpO2 adapter to the defibrillator. Use a probe appropriate for the patient. Attach the probe to the opposite limb. Avoid sites where the blood circulation changes greatly. Keep the SpO2 adapter cable and probe cable away from an electrical surgery unit. Wait until the pulse waveform becomes stable. Correct measurement cannot be done. Replace the probe with a new one. Use the specified disinfecting method. Replace the probe with a new one when its lifetime is over. Cover the probe attachment site to block the light. Check the actual AC line frequency and the AC line frequency settings. Increase the volume. Set QRS Sound to SpO2. Repair is necessary. Contact your Nihon Kohden distributor or representative.
Dotted lines appear instead of the pulse waveforms.
SpO2 probe attachment to the patient is loose. Faulty DSI or DSI/AUX out interface unit or discontinuity
Pulse waveform is not displayed on the screen.
SpO2 probe is disconnected from the SpO2 adapter. SpO2 adapter is disconnected from the defibrillator.
Unstable SpO2 value
Inappropriate probe size The probe is attached to the same limb that is used for NIBP measurement or an IBP catheter. Using electrical surgery unit.
Measuring at a site with venous pulse. Deformed or damaged SpO2 probe Probe was disinfected in a way other than the specified way. SpO2 probe is repeatedly used. Sine noise on the pulse waveform Interference by external light Correct AC line frequency is not set. No sync sound QRS Volume is set to 0 in the Setup screen - QRS Setup. QRS Sound is set to ECG in the Setup screen - QRS Setup. Faulty speaker or speaker cable discontinuity
9.13
CO2
The measured value is not displayed on the screen.
The CO2 sensor kit cable is disconnected from the SpO2/CO2 connector. CO2 gas is in the inspiration.
Connect the CO2 sensor kit cable to the SpO2/CO2 connector. With the CO2 sensor kit, measurements are based on the assumption of no CO2 gas in the inspiration. Do not connect a Jackson Rees respiration circuit or Mapleson D respiration circuit to the patient. Measurement cannot be done correctly. Replace the airway adapter with a new one. Consider the atmospheric pressure when making evaluations. Remove the cause and measure again.
The airway adapter is dirty. The measurement is preformed where atmospheric pressure is low, such as at high altitude. The measured value is high. N2O is mixed in the inspiration or when high concentration of oxygen is inspired. Jackson Rees respiration circuit or Mapleson D respiration circuit is connected to the patient. The respiration rate of the patient is very high. The respiration is irregular. Oscillation Currently doing suction. CO2 value does not change. The airway adapter is detached from the patient. The patient is in apnea.
The measured value is inaccurate.
Cannot measure correctly. Do not connect a Jackson Rees respiration circuit or Mapleson D respiration circuit to the patient. Cannot measure correctly. Cannot measure correctly. Check the respirator and remove the cause. Do not let the respirator tube in the CO2 adapter. Check the airway adapter attachment. The previous value is displayed on the screen until the next inspiration is detected. Check patient ventilation. Check the respirator and remove the cause. Connect the CO2 sensor to the respiration circuit. Replace the CO2 sensor or CO2 adapter with a new one. The red LED blinks when the respiration has not been detected for longer than 20 s regardless of the alarm setting on the defibrillator.
The respiration waveform does not appear.
Oscillation The CO2 sensor is disconnected from the respiration circuit.
The red LED on the CO2 adapter blinks.
CO2 sensor or CO2 adapter is faulty. The respiration has not been detected for longer than 20 s.
9.14
Recording
Printing is blurred. Dots are missing.
The thermal head is dirty.
Clean the thermal head with NK-specified head cleaning pen. If the symptom still appears, replace the thermal head. Contact your Nihon Kohden distributor or representative. Perform the recorder Test on the System Setup screen to check the printing quality.
NK-specified paper is not used. Recording paper cannot be set correctly. NK-specified paper is not used. The slide plate is not located correctly.
Use NK-specified recording paper. Use NK-specified recording paper. Locate the slide plate correctly. Refer to Section 2 Loading the Recording Paper. Load new recording paper. Close the door until it clicks. Press the Record key again. If the lamp does not light when you press the Record key, the key is faulty. Contact your Nihon Kohden distributor or representative. Set the recording paper correctly. Set the paper straight. Refer to Section 2 Loading the Recording Paper. Cool it down in a cooler place. If the symptom still appears, the recording unit is faulty. Contact your Nihon Kohden distributor or representative.
There is no printing.
The recording paper is not loaded. Recording unit door is not properly closed. The Recording lamp does not light.
The recording paper is set with the wrong side facing up. Paper skews to one side. Printing is light. The recording paper is not loaded correctly. The recording unit temperature is too hot.
9.15
Battery
The battery charging lamp is blinking.
The defibrillator is too hot.
Bring the defibrillator to a cool place. When the battery temperature decreases, charging resumes. Replace the battery with a new one. Faulty charging circuit. Contact your Nihon Kohden distributor or representative. Replace the battery with a new one.
After starting battery charging, the charging stops. (neither battery charging lamp nor battery charge complete lamp lights.) The Replace battery message appears.
Faulty battery Charging circuit is not working.
The battery is deteriorated.
SD Card
Symptom Possible Cause Action
Data cannot be saved in the memory card.
A version upgrade card is inserted instead of a memory card. The card is not inserted. The card is not inserted properly. A card other than specified card is inserted. Memory is full. The card is write-protected. The card is not formatted.
Insert a specified card. Insert a specified card. Firmly insert the card. Insert a specified card. Use a new card, or delete unnecessary data. Release the write-protect. Format the card in the System Setup Configuration screen.
9.16
Section 10 Maintenance
Cleaning, Disinfecting and Sterilization ............................................................................ 10.1 Defibrillator ............................................................................................................ 10.1 External Paddles .................................................................................................... 10.1 Internal Paddles ..................................................................................................... 10.2 Battery ................................................................................................................... 10.2 ECG Electrode Leads and ECG Connection Cable ............................................... 10.3 Disposal and Replacement .............................................................................................. 10.4 Battery ................................................................................................................... 10.4 Disposal of Battery Pack ............................................................................. 10.4 Replacing Battery Pack ............................................................................... 10.4 Disposable Pads .................................................................................................... 10.6 Lifetime ........................................................................................................ 10.6 Disposal ....................................................................................................... 10.6 ECG ....................................................................................................................... 10.6 Electrode Lifetime ........................................................................................ 10.6 Disposing of Electrodes ............................................................................... 10.6 Check After Use ............................................................................................................... 10.7 Periodical Checks ............................................................................................................ 10.8 Checking External Paddles .................................................................................... 10.8 Checking 270 J Energy Charge and Disarm ......................................................... 10.9 Battery Test .......................................................................................................... 10.10 Checking the Battery Appearance ....................................................................... 10.12 HV Capacitor Test ................................................................................................ 10.13 Recorder Test ...................................................................................................... 10.14 Date and Time Adjustment .................................................................................. 10.14 Periodical Replacement Schedule ................................................................................. 10.14 Repair Parts Availability Policy ....................................................................................... 10.14 Storage .......................................................................................................................... 10.15 Defibrillator and Battery ....................................................................................... 10.15 Short Term Storage (Ready for Use at Any Time) ..................................... 10.15 Long Term Storage .................................................................................... 10.15 Disposable Pads and ECG Electrodes ................................................................ 10.16
10C.1
10C.2
10. MAINTENANCE
Cleaning, Disinfecting and Sterilization
CAUTION
Before maintenance, cleaning or disinfection, turn the defibrillator power off, disconnect the power cord from the AC socket and then remove the battery from the defibrillator. Failure to follow this instruction may result in electrical shock and defibrillator malfunction.
For SpO2 adapter, SpO2 probe, CO2 sensor cable and CO2 sensor, refer to each operators manual.
Defibrillator CAUTION
Do not use the following chemicals to clean the defibrillator, pads adaptor, ECG connection cable. These chemicals melt or crack the plastic surface. Thinner, Trichloroethylene, Carbon tetrachloride, Gasoline, Benzine, Kerosene, Benzene, Toluene Do not put gauze moistened with physiological saline solution on the paddle holders. This may cause rusting or discoloration of the electrode plate of the external paddle and test electrode (metal parts of the paddle holders).
Wipe the dirt from the exterior surface of the defibrillator and paddle holders and the paste (GELAID) from the test electrodes with a soft cloth moistened with water or disinfecting alcohol then wipe them with a clean and dry cloth.
External Paddles CAUTION

Do not bend the connector pins of the external paddles. If pins are bent, replace the paddle with a new one. With a bent pin, energy cannot be discharged because of poor continuity. The external paddles cannot be sterilized. Do not heat the external paddles above 60C (140F) or put them in liquid.
Wipe the paste (GELAID) from the electrodes and handles of the external paddles with a soft cloth moistened with disinfecting alcohol then wipe them with a clean and dry cloth.
10.1
10. MAINTENANCE
Internal Paddles CAUTION

Do not bend the connector pins of the internal paddles. If pins are bent, replace the paddle with a new one. With a bent pin, energy cannot be discharged because of poor continuity. Replace an internal paddle with a new one after about 100 times autoclaving because the internal paddles can withstand up to 100 times autoclaving under the following conditions. More autoclaving may cause cable discontinuity and damage the cable surface. Replace an internal paddle with a new one after about 100 times EOG sterilization.
NOTE
The electrode and the handle cannot be separated. Wipe dirt from the electrodes and handles of the internal paddles with a soft cloth moistened with water or disinfecting alcohol then wipe them with a clean and dry cloth. After cleaning, sterilize the internal paddles by autoclaving or EOG (ethylene oxide gas). The following sterilizing conditions are examples. Refer to the manual of the sterilizing equipment. EOG Gas: EO concentration: Temperature: Relative humidity: Pressure: Period:
EO 30% + CO2 70% 940 mg/L 50C, 122F 50% 1 kg/cm2 (98 kPa ) at least 4 hours
To remove the remaining gas from the paddles after sterilization, first decrease the internal pressure of the sterilization equipment to 760 mmHg with a vacuum pump, then add carbon dioxide or antiseptic gas in the equipment. Repeat this procedure (aeration) at least 5 times. Take the paddles out of the sterilization equipment and do not use them for at least 20 days. Autoclaving Pressure Temperature Period
2.0 kg/cm2 (196 kPa) 132C (269.6F) 10 minutes
Battery
Remove dirt from the battery every 6 months.
10.2
10. MAINTENANCE
ECG Electrode Leads and ECG Connection Cable
Thoroughly wipe ECG electrode leads and an ECG connection cable with a soft cloth moistened with water, neutral detergent or disinfecting alcohol. To disinfect, wipe it with a soft cloth moistened with any of the disinfectants listed below. Use the recommended concentration. Disinfectant Glutaraldehyde solution Hydrochloric alkyldiaminoethylglycine Benzalkonium chloride Benzethonium chloride solution Chlorohexidine gluconate solution Concentration (%) 2.0 0.5 0.2 0.2 0.5
10.3
10. MAINTENANCE
Disposal and Replacement

Battery
Disposal of Battery Pack
NOTE
The battery is NiMH. Before disposing of the battery, check with your local solid waste officials for details in your area for recycling options or proper disposal. The battery is recyclable. At the end of its useful life, under various state and local laws, it may be illegal to dispose of this battery into the municipal waste stream. Before disposing of the defibrillator, remove the battery from the defibrillator. Replacing Battery Pack Replace the battery pack with a new one after one year.
NOTE
Use only the NKB-301V rechargeable battery. Write down the battery replacement date on the battery before battery replacement. Battery replacement must be performed only by service staff. 1. On the new battery write the date when usage starts. 2. Confirm that the Energy/Mode Select control is set to OFF. Disconnect the power cord from the defibrillator.
CAUTION
Before battery replacement, turn off the defibrillator power and disconnect the AC power cord from the defibrillator. Otherwise, the operator may get an electrical shock.
NOTE
While the Shutdown NOW message is displayed on the screen, do not disconnect the power cord from the defibrillator or AC outlet and do not remove the battery pack from the defibrillator. Otherwise, the internal data may be damaged. 3. Turn the knob on the battery holder cover counterclockwise and remove the battery pack holder cover.
10.4
10. MAINTENANCE 4. Disconnect the battery cable by holding the battery cable connector and remove the battery from the defibrillator.
5. Insert the new battery into the battery pack holder.
6. Securely connect the battery connector to the connector inside the battery pack holder until it clicks and locks.
7. Close the battery pack holder cover. Be careful not to pinch the cable. Secure the battery pack holder cover by turning the knob clockwise. 8. On the battery check label, write the date when usage starts. Attach the label on the defibrillator so that you can see them easily, for example, on the upper part of the right side panel. 9. Reset the date of first use of the battery. 1) Display the System Setup - Battery Test screen. 2) Press the Reset key to reset the date of first use of the battery. The Time to replace battery message appears one year after the Reset key is pressed.
NOTE
You must do this step when the battery is replaced. Otherwise, the defibrillator does not display the Time to replace battery message to prompt you to replace the battery. Operator's Manual TEC-5500 10.5
10. MAINTENANCE
Disposable Pads
Lifetime
WARNING
Replace pads after 1 hour pacing. Do not use after expiration date.
CAUTION
For long term ECG monitoring, replace pads every 24 hours.
Disposal Follow your local laws for disposing of medical waste. To prevent second infection, do not dispose of the disposable pads with other waste.
ECG
Electrode Lifetime Replace the ECG disposable electrodes with new ones about every 24 hours. Otherwise the contact impedance between the skin and electrode may increase due to drying of the electrode gel or deterioration of adhesives and correct measurement cannot be obtained. If electrode contact becomes poor, replace it with a new one. Disposing of Electrodes Follow your local laws for disposing of medical waste. To prevent second infection, do not dispose of the disposable pads with other waste.
For SpO2 adapter, SpO2 probe, CO2 sensor cable and CO2 sensor, refer to each operators manual.
10.6
10. MAINTENANCE
Check After Use

To ensure correct performance for use in an emergency, check the following items after every usage. If you find any trouble, check the defibrillator referring to Inspection in this section and take necessary remedial actions. If any abnormality is found, attach a Not available or Repair requested label on the defibrillator and contact your Nihon Kohden distributor or representative. Before turning off the power Temporarily changed settings on the System Setup screen and Setup screen are returned to original settings. When the Energy/Mode Select control is set to DISARM position, 0 J is displayed on the screen. Energy is not still being charged. Cables are disconnected from the defibrillator. Abnormality There was no abnormality during operation. No error indication is on the screen. The screen display is normal and can be seen clearly. The defibrillator is not too hot when touched. All settings are as you set them. Appearance The defibrillator is not dirty or damaged. The metal plate of the paddle holder and paddle electrode is not rusted or discolored. The operation panel and label on the defibrillator are not dirty or missing. There is no crack or damage on the defibrillator and paddles. There is no damage on the power cord. The battery check date and battery replacement date are not expired. Paddles are cleaned. Internal paddles are sterilized if necessary. There is enough paste (GELAID). If the defibrillator is in contact with liquid, it is wiped and dried thoroughly. Accessories are kept neatly. Disposable pads and ECG electrodes are disposed of properly so as not to cause second infection. There are enough consumables such as recording paper. The power cord is connected to the defibrillator to maintain battery charge. The Energy/Mode Select control is set to OFF. There are no chemical solutions or water left around the defibrillator. The defibrillator storage condition is proper.
10.7
10. MAINTENANCE
Periodical Checks
CAUTION
Assembly and disassembly of any component in the instrument should only be done by qualified service personnel. Before maintenance, cleaning or disinfection, turn the defibrillator power off, disconnect the power cord from the AC socket and then remove the battery from the defibrillator. Failure to follow this instruction may result in electrical shock and defibrillator malfunction.
Perform the Basic Checks every day. Refer to Section 2 Basic Checks. Perform the following tests and checking once a month. If any abnormality is found, contact your Nihon Kohden distributor or representative. Checking external paddles Basic Checks Checking 270 J energy charge and disarm Battery test HV capacitor test Recorder test Date and time adjustment Check the battery appearance every 6 months. To check the energy discharge, use the Basic Checks screen.
Checking External Paddles
Check that there is no crack or damage on the resin of external paddles and resin of adult electrodes. Check that there is no scratch or damage on the cables and its mold part. Pull the DISCHARGE buttons on the APEX and STERNUM paddles. If the button is pulled out, the button attachment is broken and replacement is necessary. Check energy discharge. Check the operation of the CHARGE button and DISCHARGE buttons. Confirm that there is no discontinuity in the cables.
10.8
10. MAINTENANCE
Checking 270 J Energy Charge and Disarm
Checks that the defibrillator automatically disarms. 1. Turn the Energy/Mode Select control to 270 J.
2. Leaving the paddles on their holders, press the CHARGE button on the APEX paddle to start charging. 3. Confirm that there is a beeping sound, the CHARGING message appears on the screen and the CHARGE lamp on the APEX paddle blinks.
4. When charging is completed, there is a continuous buzzing sound and the CHARGE lamp lights. Confirm that the CHARGED message and 270 J is displayed on the screen. 5. Turn the Energy/Mode select control to the DISARM position.
6. Check that the energy value on the lower right of the screen changes to 0 J in 20 seconds. If not, contact your Nihon Kohden distributor or representative.
NOTE
Do not discharge manually by pressing the DISCHARGE buttons. If any error message appears during the test, contact your Nihon Kohden distributor or representative. Do not continuously perform this check more than the specified number of charge/discharge cycles. Refer to Specification Defibrillator - Maximum continuous charge/discharge cycles at 270 J in Section 11.
10.9
10. MAINTENANCE
Battery Test
This checks the battery capacity by charging and discharging the battery. Perform this test once a month.
WARNING
If defibrillation or cardioversion is necessary during battery test, cancel the battery test and operate the defibrillator on AC power. Do not use battery power because the battery may have been discharged by the battery test.
NOTE
It takes about 4.5 hours to test a fully charged new battery at the 20C ambient temperature. It takes up to 6 hours to test a battery which has little remaining charge. If the power cord is disconnected from the defibrillator during the battery test, the battery test is canceled. Before starting the battery test, firmly connect the power cord to the AC outlet on the wall and the defibrillator. If there is a difference in temperature between the battery and the defibrillator, the battery test cannot be done properly. In such a case (for example, when you test the extra battery), insert the battery in the defibrillator and leave it for 3 hours, then perform the battery test. 1. On the System Setup - Menu screen, select Battery Test with the Item key and press the OK key. The System Setup - Battery Test screen appears. 2. Confirm that the battery is properly installed. 3. Connect the power cord to the AC outlet. 4. Confirm that enough recording paper is loaded in the recording unit. If not, load it. 5. Press the START key to start the battery test. When the battery is not fully charged, it is charged, then discharged. When the battery is fully charged, it is immediately discharged. A message shows the progress of the test. Checking battery: Battery is being charged for the battery test. Battery is being discharged. Battery is being charged for the next use.
Test result XX %:
Test finished.
NOTE
When the battery temperature is high, an error message and the battery test result appear on the screen, and the battery charging 10.10 Operator's Manual TEC-5500
10. MAINTENANCE stops. With the power cord connected, turn the Energy/Mode Select control to OFF to reduce the battery temperature, and make sure to continue the battery charging for the next use. (Refer to Error Messages During Battery Test table.) To stop the battery test, press the STOP key. 6. When test finishes, the result appears on the screen.
Reset: Press this key only when the battery pack is replaced. Refer to Inserting the Battery into the Defibrillator in Section 2.
Test result
Description
Action
Battery OK XXX% (Capacity XXX%:100%, 80% 70%) Battery WEAK XXX% Capacity XXX%: 60%, 50%)
Capacity is enough.
Battery operation is available anytime. When the defibrillator is not used, always do trickle charging. Battery operation is available only when the battery is fully charged. The time to replace the battery is coming soon. It is recommended that the battery be replaced with a new one. Only AC operation is available. Immediately replace the battery with a new one. Contact your Nihon Kohden distributor or representative.
Capacity has decreased under 70%.
Replace battery XXX% (Capacity XXX%: 40%, 0%)
Capacity has decreased under 50%.
Battery capacity is shown as 100, 80, 70, 60, 50, 40, and 0. While the test result is displayed on the screen, you can print the test result by pressing the Record key.
NOTE
Even when the capacity is 100 to 70%, replace a battery which has been used for more than one year. When you cannot confirm the capacity (%) after battery test is done, press the Record key to confirm that the battery test is correctly done. Do not press any keys or buttons during battery test. Otherwise the screen may switch to the setup screen by pressing the menu key. Operator's Manual TEC-5500 10.11
10. MAINTENANCE Error Messages During Battery Test

Message Description Action
Insert battery
Battery test cannot be done because the battery is not inserted in the defibrillator. Battery test cannot be done because AC power is not supplied to the defibrillator. A battery other than the specified one is used. Or defibrillator abnormality. A battery other than the specified one is used. Or the battery is deteriorated. Faulty defibrillator Faulty defibrillator The battery temperature is high and the battery charging stops.
First disconnect the power cord and then insert the battery into the defibrillator. Do the test again. Supply AC power to the defibrillator and do the test again. Use the specified battery pack. If the message still appears, contact your Nihon Kohden distributor or representative. Contact your Nihon Kohden distributor or representative. Contact your Nihon Kohden distributor or representative. With the power cord connected, turn the Energy/Mode Select control to OFF, and continue the battery charging for the next use.
Connect to AC power Battery discharge timed out Battery charge timed out Battery charging error Battery FET Error Battery charging stopped due to increased temperature. Turn Energy/Mode Select to OFF to charge battery
7. Press the Menu key to return to the System Setup - Menu screen.
Checking the Battery Appearance
To prevent battery trouble, check the battery appearance every 6 months. The check schedule should be written on the battery check label attached to the defibrillator. 1. Check the outside appearance of the battery pack. If there is any damage (crack, deformation, cable discontinuity and so on) on the battery or the battery leaks, replace the battery with a new one. If the battery is dirty with dust, remove it. If the battery check label says it is the day to replace the battery, replace the battery with a new one. 2. After checking, change the battery check label. If the battery is replaced, write down the date of the first use on the new battery.
10.12
10. MAINTENANCE
HV Capacitor Test
This checks the performance of the HV (high voltage) capacitor to charge the defibrillation energy. During this check, the capacitor is charged and disarms.
NOTE
Make sure that the AC power cord is connected to ensure the battery charge for emergency operation. 1. On the System Setup - Menu screen, select HV Capacitor Test with the Item key and press the OK key. The System Setup - HV Capacitor Test screen appears. 2. Set the Energy/Mode Select control to 200 J.
NOTE
If the energy is not set to 200 J, HV capacitor test cannot be done.
3. Press the CHARGE button on the external paddle (APEX) or the CHARGE/ AED button on the front panel to charge energy. The defibrillator charges the selected energy. After charging is completed, the defibrillator automatically disarms and measures the discharge energy. The check result appears on the screen.
NOTE
During charging, if the Energy/Mode Select control is turned to another position, the defibrillator immediately disarms.
Test result Description
Capacitance XXX% Capacitor test pass Capacitance XXX% Capacitor test fail
100 80 %: Capacitor performance is OK. It can be used at any time. 0 79 %: Capacitor life is almost over. Replace it with a new one. Contact your Nihon Kohden distributor or representative.
4. Press the key for Menu to return to the System Setup-Menu screen.
10.13
10. MAINTENANCE
Recorder Test
The built-in recorder can be checked by recording the preset waveforms and alphanumeric characters. Perform this test once a month.
NOTE
Make sure that the AC power cord is connected to ensure the battery charge for emergency operation. 1. On the System Setup - Menu screen, select Recorder Test with the Item and press the OK key. The recorder starts printing the preset waveforms and characters. To cancel printing, press the Record key. 2. Check the printed paper. Confirm that there is no problem in printing.
Date and Time Adjustment
Confirm that the date and time printed on the recording paper is correct. If it is not correct, set the date and time on the Date/Volume screen. Refer to Section 3.
NOTE
Make sure that the date and time printed on the recording paper is correct. The date and time on the recording paper are important parts of the medical record.
Periodical Replacement Schedule

To maintain the performance of the defibrillator, the following part must be periodically replaced. Battery pack, NKB-301V Pad adaptor, JC-765V (option for P-510/512 pads) Pad adaptor, JC-755V (option for R2 pads) Every year Every two years Every two years
Repair Parts Availability Policy

Nihon Kohden Corporation (NKC) shall stock repair parts (parts necessary to maintain the performance of the instrument) for a period of 8 years from the date of delivery. In that period NKC or its authorized agents will repair the instrument. This period may be shorter than 8 years if the board or part necessary for the faulty section is not available.
10.14
10. MAINTENANCE
Storage
NOTE
The operating environment must be more than 0oC. (Refer to Specifications in Section 11.) Otherwise the high voltage capacitor may get damaged. If the defibrillator was stored below 5oC, leave it for 3 hours or more in at least 0oC before using it.
Defibrillator and Battery
Before storage, clean the defibrillator, cables and paddles as described in Cleaning in this section. When disposable pads or internal paddles are connected to the defibrillator, disconnect them and connect external paddles to the defibrillator. Short Term Storage (Ready for Use at Any Time)
CAUTION
To prevent overheating, leave the defibrillator lying flat and do not cover it.
When the defibrillator is not used, always connect it to AC power to maintain the battery charge with trickle charging. Confirm that the AC lamp is on. Check the battery appearance every 6 months and do the battery test every month. Store in a cool place (20 to 35C, 4 to 95F). If the defibrillator is stored in high temperature, the battery deteriorates.
Long Term Storage If you store the defibrillator not connected to AC power, remove the battery from the defibrillator. Otherwise, the battery over-discharged after 1 month in the defibrillator without AC power. When you store a battery outside the defibrillator, do the battery test every 6 months. Store the battery and defibrillator in a cool place (20 to 35C, 4 to 95F). If the battery is stored at high temperature, it deteriorates.
10.15
10. MAINTENANCE
Disposable Pads and ECG Electrodes
CAUTION
Store the disposable pads in an environment described on the pads package. If stored in an environment other than specified, the pads become unusable. Do not put heavy thing on pads or do not bend pads. Pads get damaged and deteriorated, and may cause burn to the patient.
Store the disposable pads and ECG electrodes in a cool place (5 to 35C, 41 to 95F). Each pad has its own lifetime. Use the pad within its lifetime. Do not put heavy thing on pads and ECG electrodes. Otherwise, the gel may flow out.
10.16
Section 11 Reference
Specifications ................................................................................................................... 11.1 Defibrillator .................................................................................................... 11.1 Noninvasive Pacing (TEC-5531 series only) ................................................. 11.3 External Paddle (ND-552VB/VE/VK) ............................................................. 11.3 Battery .......................................................................................................... 11.3 Clock Accuracy ............................................................................................. 11.3 Environment .................................................................................................. 11.3 Safety ........................................................................................................... 11.4 Monitor .......................................................................................................... 11.4 ECG Amplifier ............................................................................................... 11.4 Recorder ........................................................................................................ 11.5 Rhythm Recognition Detector ....................................................................... 11.5 Power Requirements ..................................................................................... 11.5 Dimensions and Weight ................................................................................. 11.5 Electromagnetic Compatibility ....................................................................... 11.6 Reference ........................................................................................................................ 11.10 Standard Accessories ..................................................................................................... 11.11 Options/Consumables ..................................................................................................... 11.12 Pin Assignment ............................................................................................................... 11.14 AUX Connector of the QI-553V DSI/AUX OUT Interface Unit ................................ 11.14 General Requirements for Connecting Medical Electrical System ................................... 11.15
11C.1
11C.2
11. REFERENCE
Specifications
Defibrillator Output energy (across 50 ) Energy accuracy Output waveform Charging time
2, 3, 5, 7, 10, 15, 20, 30, 50, 70, 100, 150, 200 and 270 J 2 J: 0.5 J, 3 J: 1 J,5 to 15 J: 2 J, 20 to 270 J: 10% Biphasic, truncated exponential constant power (across 50 )
Manual mode When powered by AC 100V to 240V: When powered by 90% of the rated mains voltage: When powered by a fully charged new battery at 20C ambient temperature: After 15 discharges at 270 J with a fully charged new battery at 20C ambient temperature: When powered by 90% of the rated mains voltage or after 15 discharges at 270 J with a fully charged new battery at 20C ambient temperature: AED mode When powered by 90% of the rated mains voltage or after 15 discharges at 270 J with a fully charged new battery at 20C ambient temperature:
to 270 J, maximum 5 s to 200 J, maximum 3 s to 270 J, maximum 5 s to 270 J, maximum 5 s to 200 J, maximum 3 s to 270 J, maximum 5 s Power on to 270 J, maximum 7 s
Power on to 270 J: typical 17 s, maximum 31 s Standby mode to 270 J: typical 15 s, maximum 29 s
Charging display Synchronized discharge
Displays the charged energy value on the screen Available From the peak of R wave to the peak of discharge: within 60 ms Maximum continuous charge/discharge cycles at 270 J 20 cycles: 3 cycles per minute with 1 minute cool down period after every 1 minute charge/ discharge period 15 cycles: 3 cycles per minute with no cool down period Maximum skin-disposable pad contact impedance for energy charging: 280
Delivered energy : 270 J

Load resistance () First phase Ipk1 (A) D1 (ms) Second phase Ipk2 (A) D2 (ms)
25 50 75 100 125 150 175
67.3 41.1 29.5 22.9 18.8 15.9 13.8
3.85 6.35 8.86 11.4 13.9 16.4 18.9
15.5 12.7 11.0 9.81 8.96 8.29 7.76
3.62 3.62 3.62 3.62 3.62 3.62 3.62

11.1
11. REFERENCE
60 25
current [A]
60 50 40
current [A]
40
20
20
-20 0 2 4 6 8 10 12 14 16 18 20 22 24 time [ms]
-20 0 2 4 6 8 10 12 14 16 18 20 22 24
time [ms]
60 75 40
30 100 20
current [A]
20
current [A]
0 2 4 6 8 10 12 14 16 18 20 22 24
10
-20 time [ms]
-10 0 2 4 6 8 10 12 14 16 18 20 22 24
time [ms]
30 125 20
30 150 20
current [A]
10
current [A]
10
-10 0 2 4 6 8 10 12 14 16 18 20 22 24
-10 0 2 4 6 8 10 12 14 16 18 20 22 24
time [ms]
time [ms]
30 175 20
current [A]
10
-10 0 2 4 6 8 10 12 14 16 18 20 22 24
time [ms]
11.2
11. REFERENCE Noninvasive Pacing (TEC-5531 series only) Pacing rate 40 to 180 pulse/min in 10 pulse/min steps Output current 8 to 200 mA in 1, 2, 5 or 10 mA steps (Set on the System Setup screen) Pacing modes Fixed and Demand Maximum load resistance Outputs 200 mA across 250 , 120 mA across 500
External Paddle (ND-552VB/VE/VK) Paddle electrode size For adults: 70 3 106 3 (mm2) For children: 45 3 53 3 (mm2) Paddle cord length 2.0 m or more (when it is pulled by 18 N force)
Battery Type Ni-MH battery Capacity Nominal voltage: 12 V Rated capacity: 2800 mAh With fully charged new battery at 20C ambient temperature Minimum 70 discharges at 270 J Minimum 150 minutes continuous monitoring Minimum 90 minutes fixed mode pacing (180 pulse/min, 200 mA) With the fully charged new battery at 0C, the defibrillator can perform: Minimum 50 discharges at 270 J
Clock Accuracy At surrounding temeprature 25C (77F): 3 min/month At storage temperatures -20 to 70C (4 to 158F): 5 min/month
Environment Operating temperature Operating humidity Operating atmospheric pressure
0 to 45C (32 to 113F) 30 to 95% (relative humidity, non-condensing) 700 to 1060 hPa (Recording paper may jam, if it is wet.) 20 to 70C (4 to 158F) 10 to 95% (relative humidity) 500 to 1060 hPa
Storage temperature Storage humidity Storage atmospheric pressure
11.3
11. REFERENCE Safety Safety standard
IEC 60601-1: 1988 IEC 60601-1 Amendment 1: 1991 IEC 60601-1 Amendment 2: 1995 IEC 60601-1-2: 2001 IEC 60601-2-4: 2002 According to the type of protection against electrical shock Battery power: INTERNALLY POWERED EQUIPMENT AC power: CLASS I EQUIPMENT According to the degree of protection against electrical shock DEFIBRILLATION-PROOF TYPE BF APPLIED PART External paddles, disposable pads, SpO2 adapter and CO2 sensor kit
DEFIBRILLATION-PROOF TYPE CF APPLIED PART Internal paddles, ECG connection cable According to the degree of protection against harmful ingress of water IPX1 According to the degree of safety of application in the presence of a FLAMMABLE ANAESTHETIC MIXTURE WITH AIR, OR WITH OXYGEN OR NITROUS OXIDE EQUIPMENT not suitable for use in the presence of FLAMMABLE ANAESTHETIC MIXTURE WITH AIR, OR WITH OXYGEN OR NITROUS OXIDE Mode of operation Continuous operation with intermittent load : Operation at defibrillation mode Continuous operation : All operation except above mentioned
Monitor Effective display area Sweep length Sweep speed Sensitivity Amplitude limit
117.2(W) 88.4(H) mm (5.7 inch) 97 mm 25 mm/s, 50 mm/s 10 mm/1mV 5% (sensitivity 1) 40 mm
ECG Amplifier Input signal Frequency response
Input impedance
CMRR AC filter Pacing pulse rejection External ECG input sensitivity Heart rate counting range
PADDLE, I, II, III, aVR, aVL, aVF, V, AUX Through paddles: 0.5 to 20 Hz (-3 dB) Through ECG connection cable: 0.05 to 150 Hz (-3 dB) AUX: 0.05 to 150 Hz (-3 dB) Through paddles: 100 k Through ECG connection cable: 5 M(at 10 Hz 1mV) AUX: 100 k 10% 100 dB (against chassis ground) when AC filter is ON Available (common with 50/60 Hz) ON at -20 dB, OFF ON, OFF 10 mm/V 5% (sensitivity 1) Defibrillation or monitoring mode: 15 to 300 bpm Pacing mode: 15 to 220 bpm Operator's Manual TEC-5500
11.4
11. REFERENCE Recorder Paper speed Types of recording Manual recording: Automatic recording:
Real time/delayed ECG waveform recording: 50, 25 mm/s real time/delayed waveform recording, report recording, event recording record on charging after discharge, alarm recording, periodic recording
Rhythm Recognition Detector We evaluated the rhythm recognition detector of the TEC-5500 series defibrillator using the official electrocardiogram database provided by AHA (American Heart Association) and MIT (Massachusetts Institute of Technology) and an electrocardiogram database of over 3000 electrocardiograms from hospitals in Japan. According to our own evaluation, the rhythm recognition detector of the TEC-5500 series defibrillator meets the equivalent of AAMI standards ANSI/AAMI DF-39-1993 3.3.18. Shockable Rhythm VF Sensitivity : 90% Shockable Rhythm VT Sensitivity: 75% All other Non-Shockable Rhythm Sensitivity: 95%
Power Requirements AC Line voltage Line frequency Power input DC (Battery) Power voltage Power consumption Charging time
100 to 240 V 50/60 Hz (automatic switching) Intermittent load: 450 VA or less Continuous load: 200 VA or less 12 V Intermittent load: 18 A or less Continuous load: 4.2 A or less 3 hours or less (with AC, with the power OFF)
Dimensions and Weight Dimensions 290 (W) 172 (H) 355 (D) mm Weight TEC-5521 series defibrillator 6.1 kg (External paddles use, AC unit without battery) 5.3 kg (Pad adaptor use, AC unit without battery) TEC-5531 series defibrillator 6.3 kg (External paddles use, AC unit without battery) 5.5 kg (Pad adaptor use, AC unit without battery)
11.5
11. REFERENCE Electromagnetic Compatibility Standard IEC 60601-1-2: 2001 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests IEC 60601-2-4: 2002 Medical electrical equipment - Part 2-4: Particular requirement for the safety of cardiac defibrillators Electromagnetic Emissions/Immunity Ccompliance Level and Guidance
Guidance and manufacturer's declaration - electromagnetic emissions The TEC-5500 series is intended for use in the electromagnetic environment specified below. The customer or the user of the TEC-5500 series should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance The TEC-5500 series uses RF energy only for its internal RF emissions function. Therefore, its RF emissions are very low and are not Group 1 CISPR 11 likely to cause any interference in nearby electronic equipment. RF emissions Class B CISPR 11 The TEC-5500 series is suitable for use in all establishments, Harmonic emissions including domestic establishments and those directly connected Class A IEC 61000-3-2 to the public low-voltage power supply network that supplies Voltage fluctuations/ buildings used for domestic purposes. flicker emissions Complies IEC 61000-3-3
Guidance and manufacturer's declaration - electromagnetic immunity The TEC-5500 series is intended for use in the electromagnetic environment specified below. The customer or the user of the TEC-5500 series should assure that it is used in such an environment. Electromagnetic environment Immunity test IEC 60601 test level Compliance level guidance Electrostatic 6 kV contact 6 kV contact Floors should be wood, concrete or ceramic discharge (ESD) 8 kV air 8 kV air tile. If floors are covered with synthetic IEC 61000-4-2 material, the relative humidity should be at least 30 %. Electrical fast 2 kV for power supply 2 kV for power supply Mains power quality should be that of a transient/burst lines lines typical commercial or hospital environment. IEC 61000-4-4 Surge 1 kV differential mode 1 kV differential mode Mains power quality should be that of a IEC 61000-4-5 typical commercial or hospital environment. 2 kV common mode 2 kV common mode Voltage dips, short <5% Ut <5% Ut Mains power quality should be that of a interruptions and (>95 % dip in Ut) (>95% dip in Ut) typical commercial or hospital environment. voltage variations on for 0.5 cycles for 0.5 cycles If the user of the TEC-5500 series requires power supply input continued operation during power mains lines interruptions, it is recommended that the 40% Ut 40% Ut IEC 61000-4-11 TEC-5500 series be powered from an (60% dip in Ut) for (60 % dip in Ut) for uninterruptible power supply or a battery. 5 cycles 5 cycles 70% Ut (30% dip in Ut) for 25 cycles <5% Ut (>95 % dip in Ut) for 5 seconds 70% Ut (30% dip in Ut) for 25 cycles <5% Ut (>95 % dip in Ut) for 5 seconds
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11
Power frequency 3 A/m 3 A/m (50/60 Hz) magnetic field IEC 61000-4-8 NOTE: Ut is the AC mains voltage prior to application of the test level.
Mains power quality should be that of a typical commercial or hospital environment. If the user of the TEC-5500 series requires continued operation during power mains interruptions, it is recommended that the TEC-5500 series be powered from an uninterruptible power supply or a battery. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
11.6
11. REFERENCE
Guidance and manufacturer's declaration - electromagnetic immunity (1/2) The TEC-5500 series is intended for use in the electromagnetic environment specified below. The customer or the user of the TEC-5500 series should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the TEC-5500 series, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Conducted RF EC 61000-4-6 Requirement of IEC-60601-2-4: 3 Vrms 150 kHz to 80 MHz outside ISM bandsa 3 Vrms Recommended separation distance d = 1.2P where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). b Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, c should be less than the compliance level in each frequency range. d Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1: NOTE 2: a: b:
c:
d:
At 80 MHz and 800 MHz, the higher frequency range applies. These guidelines might not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz. The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in these frequency ranges. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the TEC-5500 series is used exceeds the applicable RF compliance level above, the TEC-5500 series should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the TEC-5500 series. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. The JL-951T3 SpO2 adapter complies with IEC 60601-2: 1993 and it complies with IEC 60601-2: 2001 requirement except for the item Conducted RF. RRD is the abbreviation of Rhythm Recognition Detector.
11.7
11. REFERENCE
Guidance and manufacturer's declaration - electromagnetic immunity (2/2) The TEC-5500 series is intended for use in the electromagnetic environment specified below. The customer or the user of the TEC-5500 series should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the TEC-5500 series , including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Radiated RF EC 61000-4-3 Requirement of IEC-60601-2-4: Correct operation of RRD: 10 V/m 80 MHz to 2.5 GHz No inadvertent energy delivery is allowed: 20 V/m 80 MHz to 2.5 GHz Recommended separation distance d = 1.2P 80 to 800 MHz d = 2.3P 800 MHz to 2.5 GHz 3 V/m Additional requirement of IEC 60601-2-4 Correct operation of RRD: d = 4.0P 80 to 800 MHz d = 7.7P 800 MHz to 2.5 GHz 20 V/m No inadvertent energy delivery is allowed: d = 0.6P 80 to 800 MHz d = 1.2P 800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). b Field strengths from fixed RF transmitters, as deter mined by an electromagnetic site survey, c should be less than the compliance level in each frequency range. d Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1: NOTE 2: a: b:
c:
d:
At 80 MHz and 800 MHz, the higher frequency range applies. These guidelines might not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz. The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in these frequency ranges. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the TEC-5500 series is used exceeds the applicable RF compliance level above, the TEC-5500 series should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the TEC-5500 series. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
11.8
11. REFERENCE
Recommended separation distances between portable and mobile RF communications equipment and the TEC-5500 series The TEC-5500 series is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the TEC-5500 series can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the TEC-5500 series as recommended below, according to the maximum output power of the communications equipment. Separation distance according to frequency of transmitter (m) Rated maximum output 150 kHz to 80 MHz 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz power of transmitter outside ISM bands in ISM bands d = 4.0P d = 7.7P (W) d = 1.2P d = 1.2P 0.01 0.12 0.12 0.4 0.77 0,1 0.38 0.38 1.3 2.4 1 1.2 1.2 4.0 7.7 10 3.8 3.8 13 27 100 12 12 40 77 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz. NOTE 3: An additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas. NOTE 4: These guidelines might not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. The equations and values in the above table show the condition that the RRD (Rhythm Recognition Detector) regulated in IEC 60601-2-4: 2002 does not receive electromagnetic interference.
System Configuration at EMC testing We tested that the defibrillator complies with IEC 60601-1-1: 2001 and IEC 60601-2-4: 2002 with the following configuration. If other cables and equipments are used with the defibrillator, the defibrillator may not comply with these standards.
Configuration at testing Cable length (m) Defibrillator, TEC-5521/5531 series DSI interface unit, QI-552V External paddles, ND-552V 0.406 Pad adapter, JC-765V** 3.50 ECG connection cable, BC-763V 3.30 CO2 sensor kit, TG-901T3 2.99 SO2 adapter, JL-951T3* 2.50 Finger probe, TL-201T* 1.60 Battery pack, NKB-301V (YZ-024H9) Holter card, QM-064D * When the SpO2 adapter and finger probe are connected to the defibrillator, the defibrillator does not comply with the item Conducted RF (IEC 60601-1-2: 2001). ** When the pad adapter is connected to the defibrillator, the compliance level of the item Radiated RF (IEC 60601-2-4:2002) is 3 V/m.
11.9
11. REFERENCE
Reference
1. KERBER, RE, CARTER, J., KLEIN, S, et al. Open chest defibrillation during cardiac surgery: Energy and current requirements. American Journal of Cardiology, 46:393-396, 1980 2. RACKER, WA, GUINN, GA, GEDDES, LA, et al. The electrical dose for direct ventricular defibrillation in man. Journal of Thoracic Cardiovascular Surgery, 75:224-226, 1978 3. RUBIO, PA and FARRELL, EM. Low-energy direct defibrillation of the human heart Annals of Thoracic Surgery, 27:32-33, 1979
11.10
11. REFERENCE
Standard Accessories
No. Name Qty Model or Code No. Supply Code No.
1 2 3
Recording paper (Z-fold) Contact gel GELAID Battery check label (for defibrillator)
1 1 1
FQS50-2-100 --6124-022441
A226 F015 ---
NOTE
When you order accessories/consumables which have a supply code No., specify the supply code No., not the model or code No.
11.11
11. REFERENCE
Options/Consumables
Name TEC accessory set (100V/IEC) BC-763V ECG connection cable (IEC, 3 leads) + Power cord H TEC accessory set (200V/IEC) BC-763V ECG connection cable (IEC, 3 leads) + Power cord N TEC accessory set (100V/AHA) BC-763VA ECG connection cable (AHA, 3 leads) + Power cord H TEC accessory set (200/AHA) BC-763VA ECG connection cable (AHA, 3 leads) + Power cord N ECG connection cable (IEC, 3 leads) ECG connection cable (AHA, 3 leads) ECG connection cable (IEC, 5 leads) ECG connection cable (AHA, 5 leads) External ECG cable Connection cable Connection cable Pad adaptor for P-510/P-520 Pad adaptor for R2 pads Battery pack NKB-301V Power cord type N Power cord type H Ground lead type E Cart Cart tray assembly (option for the cart) Recording paper (roll) Paste holder kit Disposable ECG electrode Vitrode C Disposable pad for adult Disposable pad for child Internal paddle electrode, 25 mm Internal paddle electrode, 35 mm Internal paddle electrode, 45 mm Internal paddle electrode, 55 mm Internal paddle electrode, 65 mm Internal paddle electrode, 75 mm Pediatric electrode assy, 44 mm DSI interface unit DSI/AUX out interface unit Holter card (SD memory card) Qty 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1set 150/set 1set 1set 1set 1set 1set 1set 1set 1set 1 1 1 1 Model or Code No. YZ-024H3 YZ-024H4 YZ-024H5 YZ-024H6 BC-763V BC-763VA BC-765V BC-765VA JC-761V JC-762V JC-763V JC-765V JC-755V YZ-024H9 314839B 186656A 544582B KD-028A DI-001A RQS50-2-100 YZ-025H0 --P-510 P-512 ND-762V ND-763V ND-764V ND-765V ND-766V ND-767V ND-612V QI-552V QI-553V QM-064D Supply code No. --------K353A K352A K353B K352B L151 L152 L153 ----X065 L936 L935 ------A226 --G204 H315 H316 ---------------------
11.12
11. REFERENCE
Name CO2 measurement CO2 sensor kit Airway adapter CO2 sensor kit Nasal Adapter (for nasal breathing) Nasal Adapter (for naso-oral breathing) Nasal Adapter (for oxygen cannula adjustment) SpO2 measurement SpO2 adapter Finger probe BluPRO Multi-site probe BluPRO Multi-site Y prove SpO2 probe (for adult) (1.6 m) BluPRO SpO2 probe (for child) (1.6 m) BluPRO SpO2 probe (for neonate) (1.6 m) BluPRO SpO2 probe (for adult and neonate) (0.8 m) SpO2 probe (for adult and neonate) (1.6 m) SpO2 probe (for adult, child and infant) (0.8 m) SpO2 probe (for adult, child and infant) (1.6 m) Cottony tape
Qty 1 50/set 1 30/set 30/set 30/set 1 1 1 1 5/pcs 5/pcs 5/pcs 5/pcs 5/pcs 5/pcs 5/pcs 20
Model or Code No. TG-901T3 YG-101T TG-921T3 YG-120T YG-121T YG-122T JL-951T3 TL-201T TL-220T TE-260T TL-251T TL-252T TL-253T TL-051S TL-052S TL-061S TL-062S 340703
Supply code No. P906 R801 P908 V921 V922 V923 Y090 P225F P225G P205A P201A P201B P201C P228A P228B P229A P229B P259
CAUTION
Only use the KD-028A cart for this defibrillator. If another cart is used, it may tip over or the defibrillator may fall off.
The ND-762V, 763V, 764V and 765V internal paddle do not comply with IEC 60601-2-4 56.101 standard for contact area for adult use. The ND-762V internal paddle does not comply with IEC 60601-2-4 56.101 standard for contact area for pediatric use. There are two types of TG-921T3 CO2 sensor kit. One complies with IEC 606011-2: 2001, the other does not. CO2 sensor kits which comply with this standard have a IEC 60601-1-2: 2001 stamp. The defibrillator only complies with this standard used with the CO2 sensor kit which complies with this standard.
11.13
11. REFERENCE
Pin Assignment
CAUTION
Connect only the specified instrument to the defibrillator and follow the specified procedure. Failure to follow this warning may result in electrical shock or injury to the patient and operator, and cause fire or instrument malfunction.
AUX Connector of the QI553V DSI/AUX OUT Interface Unit
This connector is for analog ECG output. Mating plug: 3.5 mm plug
Output sensitivity: 0.5 V/1 mV 10% Output impedance: 1k or less
11.14
11. REFERENCE
General Requirements for Connecting Medical Electrical System

When more than one electrical instrument is used, there may be electrical potential difference between the instruments. Potential difference between instruments may cause current to flow to the patient connected to the instruments, resulting in electrical shock (micro shock). Therefore, electrical instruments must be appropriately installed as specified in IEC 60601-1-1. The following is an extract from IEC 60601-1-1 Medical electrical equipment Part 1: General requirements for safety. For details, refer to IEC 60601-1-1 and consult with a biomedical engineer. Examples of combinations of MEDICAL ELECTRICAL EQUIPMENT and non-medical electrical equipment
Situation No. Equipment A Equipment B Solution
IEC 60601/X
OK OK, if ENCLOSURE LEAKAGE CURRENT is less than 0.5 mA. If the ENCLOSURE LEAKAGE CURRENT is more than 0.5 mA: Solution Q (separating transformers). IEC 60601/B OK
1a
IEC XXXXX
2a 2b 2c 3a 3b 3c 4 5a 5b 6a 6b
IEC 60601/X IEC 60601/F IEC 60601/B IEC 60601/X IEC 60601/F IEC 60601/B see 3a, 3b, 3c IEC 60601/X IEC 60601/X IEC 60601/X IEC 60601/X
IEC XXXXX for B any one of P, Q, R IEC XXXXX IEC 60601/B for A solution P for B any one of P, Q, R OK
IEC XXXXX OK IEC XXXXX for A solution P
for A solution P or S (groundloop possible) for A solution P or S (groundloop IEC XXXXX possible) IEC 60601/B IEC 60601/X OK (with S)
IEC XXXXX OK (with S)
IEC 60601/B = IEC 60601-1 EQUIPMENT of TYPE B with PATIENT connection IEC 60601/F = IEC 60601-1 EQUIPMENT of TYPE BF or TYPE CF (or TYPE B without PATIENT connection) IEC 60601/X = IEC 60601-1 EQUIPMENT of TYPE B or TYPE BF or TYPE CF IEC XXXXX = Equipment complying with e.g. IEC 348, IEC 950 etc. P: Q: R: S: Operator's Manual TEC-5500 additional protective earth additional separating transformer floating power supply separation 11.15
11. REFERENCE
PATIENT ENVIRONMENT A PE A PE 3 A PE A PE PE 5 A PE B (V) PE 6 A PE B (V) PE B PE B PE B Medically-used room Non-medically used room
Situation No.
Legend: (V) = Potential difference between different localities. > < = SEPARATION DEVICE. PE = Protective earth.
11.16

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Defibrillator

General .................................................................................. 1C.1

Preparation ........................................................................... 2C.1

Operator's Manual TEC-5500

System Setup Screen and Setup Screen .......................... 3C.1

Defibrillation, Synchronized Cardioversion and AED ..... 4C.1

Operator's Manual TEC-5500

Pacing .................................................................................... 5C.1

Monitoring ............................................................................. 6C.1

Operator's Manual TEC-5500

Operator's Manual TEC-5500

Alarm Function ..................................................................... 7C.1

Recording ............................................................................. 8C.1

Operator's Manual TEC-5500

Messages and Troubleshooting ......................................... 9C.1

Section 10 Maintenance ....................................................................... 10C.1

Operator's Manual TEC-5500

Section 11 Reference ............................................................................ 11C.1

Operator's Manual TEC-5500

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Operator's Manual TEC-5500

Operator's Manual TEC-5500

Operator's Manual TEC-5500

EMC RELATED CAUTION

Operator's Manual TEC-5500

Operator's Manual TEC-5500

Operator's Manual TEC-5500

Explanations of the Symbols in this Manual and Instrument

Charged (Battery charging is finished)

Real time/delayed recording

Attention, consult operators manual

Provides ActiBiphasic waveform defibrillation function

Inserting or removing the memory card Defibrillation-proof type BF applied part

Complies with IEC 60529 IPX1

Complies with IEC 60529 IPX4

Defibrillation-proof type CF applied part

Complies with IEC 60529 IPX7

Operator's Manual TEC-5500

Battery fully charged

Add Z-fold recording paper

More than 2/3 battery charge remains

QRS sync mark

More than 1/3 battery charge remains

The point of implanted pacemaker pulse output

Battery power for one 270 J charging remains

Battery operation not available

Real time/delayed recording

Cannot write to the SD card

Writing to the SD card

Can eject SD card

ECG cascaded display

AED analysis paused

SpO2 pulse wave unstable

VF/VT alarm off

Operator's Manual TEC-5500

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Operator's Manual TEC-5500

Operator's Manual TEC-5500

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Operator's Manual TEC-5500

Models and Functions

Defibrillation and synchronized cardioversion

External paddles Internal paddles Disposable pads Pediatric electrode assy 44 mm