Heyer Vizor 10-12 - Manual 2.0 en

HEYER Medical - VizOR 10 / VizOR 12
HEYER Medical AG
Patientenmonitoring
Operator’s Manual
Rev. 2.0 – 09/11
OPERATOR’S MANUAL
VIZOR10 Patient Monitor

VIZOR12 Patient Monitor
INNOVATION AS A SERVICE TO THE PATIENT

Distributed by:
Manufactured by:
Carl-Heyer Strasse 1-3

D-56130 BAD EMS
Deutschland – GERMANY
Tel: +49 2603 791-145
Fax: +49 2603 791-209
Web site: WWW.HEYERMEDICAL.DE
Email: INFO@HEYERMEDICAL.DE
Contents
CHAPTER 1 INTRODUCTION…………………………………………………...... 1-1
1.1 GENERAL WARNING……..………………………………….……..... 1-1
1.2 GENERAL INFORMATION ………………………………….……...... 1-4
1.3 SCREEN DISPLAY………………...……………………………........... 1-6
1.4 BUTTON FUNCTIONS………………………………………….…..... 1-7
1.5 INTERFACES…………………………………………………………. 1-9
1.6 BUILT-IN BATTERY…………………………………………………. 1-12
CHAPTER 2 SYSTEM CONFIGURATION……………………………………… 2-1
2.1 SIGMA…………………………………………………………………. 2-2
2.2 TREND………………………………………………………………… 2-2
2.3 ALARM………………………………………………………………... 2-4
2.4 SETUP…………………………………………………………………. 2-5
2.5 PATIENT INFORMATION…………………………………………… 2-6
2.6 RECORDER…………………………………………………………… 2-7
2.7 ABOUT………………………………………………………………… 2-8
CHAPTER 3 ALARM………………………………………………………………. 3-1
3.1 ALARM MODES……………………………………………………… 3-1
3.2 ALARM CAUSE………………………………………………………. 3-2
3.3 ALARM SILENCE BUTTON FUNCTION……………………………. 3-2
3.4 PARAMETER ALARM……………………………………………….. 3-2
3.5 WHEN AN ALARM OCCURS……………………………………….. 3-3
CHAPTER 4 ECG MONITORING………………………………………………... 4-1
4.1 GENERAL................................................................................................. 4-1
4.2 ECG WINDOW......................................................................................... 4-6
4.3 ECG ALARM MESSAGES...................................................................... 4-10
4.4 ECG CABLE CLEANING…………………………………………….. 4-12
CHAPTER 5 RESP MONITORING …………………………….………………… 5-1
5.1 GENERAL................................................................................................. 5-1
5.2 RESP WINDPW……………………………………………………….. 5-1
5.3 RESP ALARM MESSAGES.................................................................... 5-3
CHAPTER 6 SPO2 MONITORING………………………………………………. 6-1
6.1 GENERAL................................................................................................. 6-1
6.2 SPO2 WINDOW………………………………………………………. 6-6
6.3 SPO2 ALARM MESSAGES..................................................................... 6-8
6.4 SPO2 PROBE CLEANING……………………………………………. 6-9
CHAPTER 7 NIBP MONITORING…………………………………………….. 7-1
7.1 GENERAL................................................................................................. 7-1
7.2 NIBP WINDOW……………………………………………………….. 7-4
7.3 NIBP ALARM MESSAGES..................................................................... 7-7
7.4 NIBP CUFF CLEANING………………………...……………………... 7-9
CHAPTER 8 TEMP MONITORING……………………………………………… 8-1
8.1 GENERAL................................................................................................. 8-1
8.2 TEMP WINDOW……………………………………………………… 8-2
8.3 TEMP ALARM MESSAGES................................................................... 8-3
8.4 TEMP SENSOR CLEANING…………………………………………. 8-3
CHAPTER 9 IBP MONITORING…………….………………...…………………. 9-1

9.1 GENERAL................................................................................................ 9-1
9.2 IBP WINDOW……………….………………………………………… 9-2
9.3 IBP ALARM MESSAGES....................................................................... 9-8
9.4 IBP TRANSDUCER CLEANING........................................................... 9-9
CHAPTER 10 GAS MONITORING (mainstream)................................................... 10-1
10.1 GENERAL.............................................................................................. 10-1
10.2 GAS WINDOW……………………………………….…………….. 10-10
10.3 GAS ALARM MESSAGES................................................................... 10-17
10.4 IRMA SENSOR CLEANING...…………….…………….…………. 10-20
CHAPTER 11 GAS MONITORING (sidestream)……………………………….. 11-1
11.1 GENERAL……………………………………………………………. 11-1
11.2 GAS WINDOW………………………………………………………. 11-7
11.3 ISA SENSOR ALARM MESSAGES…………….………………….. 11-13
11.4 ISA SENSOR CLEANING...………………………………………… 11-16
CHAPTER 12 CSM MONITORING……………………………………………….. 12-1
12.1 GENERAL…………………………………………………………….. 12-1
12-2 CSM SYSTEM...……………………………………………………… 12-6
12-2-1 CSM MODULE……………………………………………… 12-6
12-2-2 CSM ON MONITOR………………………………………... 12-14
12.3 CSM ALARM MESSAGE AND TROUBLESHOOTING…............... 12-17
12.4 CSM MODULE CLEANING AND MAINTENANCE………………. 12-19
CHAPTER 13 ST MONITORING ……………………………...………………….. 13-1
13.1 GENERAL…………………………………………………………….. 13-1
13.2 ST ANALYSIS WINDOW……………………………………………. 13-3
13.3 ST ALARM MESSAGE………………………………………………. 13-5
CHAPTER 14 ARRHYTHMIA ITORING ………………….…………………….. 14-1
14.1 GENERAL…………………………………………………………….. 14-1
14.2 ARR ANALYSIS WINDOW…………………………………………. 14-3
CHAPTER 15 RECORDING……………………………………..……………….… 15-1
15.1 GENERAL.............................................................................................. 15-1
15.2 RECORDING TYPE………………………………………..………... 15-1
15.3 RECORDER OPERATIONS AND STATUS MESSAGES..………... 15-2
15.4 RECORDER PAPER………………………………………………….. 15-2
15.5 RECORDER STATUS MESSAGE…………………………………... 15-4
15.6 RECORER CLEANING………………………………………………. 15-4
CHAPTER 16 PATIENT SAFETY………………………………………..……….. 16-1
CHAPTER 17 CARE AND CLEANING…………………………………..………. 17-1
17.1 SYSTEM CHECK…………………………………………..………... 17-1
17.2 CLEANING………………………………………………..…………. 17-1
17.3 STERILIZATION…………………………………………..………… 17-2
17.4 DISINFECTION…………………………………………..………….. 17-2
CHAPTER 18GETTING STARTED…………………………………..………….. 18-1
18.1 OPEN THE PACKAGE AND CHECK................................................. 18-1
18.2 PLACE THE BATTERY FUSE............................................................. 18-1
18.3 CONNECT THE POWER CABLES………………………...………... 18-1
18.4 POWER ON THE MONITOR…………………...…………………… 18-1
18.5 CONNECT PATIENT SENSORS………………………………….. 18-2
CHAPTER 19 PRODUCTION SPECIFICATION……………………...………… 19-1

CHAPTER 20 TROBULE SHOOTING..................................................................... 1
APPENDIX I LIST OF MONITORS PARAMETERS (SELECTIONS AND DEFAULTS)
APPENDIX II MONITOR ERROR MESSAGES
APPENDIX III EMC
APPENDIX IV IRMA Design and theory
APPENDIX V ISA Design and theory
Chapter 1 Introduction
■ For an overall safety instruction, please refer to 1.1 General Warning.
■ For an overall introduction to the monitor, please refer to 1.2 General Information.
■ For various messages displayed on the screen, please refer to 1.3 Display Screen.
■ For basic operating instructions, please refer to 1.4 Button Function and Basic Operation.
■ For allocation of interface sockets, please refer to 1.5 Peripheral Interfaces.
■ For important facts to be noted during the battery recharging procedure, please refer to
1.6 Built-in Rechargeable Battery.
1.1 General Warning

Warning
Portable Patient Monitor is intended for clinical monitoring application with operation only
granted to appropriate medical staff.
Warning
Before use, carefully read this manual, directions for use of any accessories, all precautions,
and all specifications.
Warning
The vital sign monitor is intended for use only as an adjunct in patient assessment .It must be
used in conjunction with clinical signs and symptoms.
Warning
If the accuracy of any measurement does not seem reasonable, first check the patient's vital
signs by alternate means and then check the monitor for proper functioning.
Warning
Do not use the patient monitor during magnetic resonance imaging (MRI) scanning. Induced
current could potentially cause burns. The monitor may affect the MRI image, and the MRI
unit may affect the accuracy of monitor measurements.
Warning
Do not place the monitor in any position that might cause it to fall on the patient.
Warning
There could be hazard of electrical shock by opening the monitor casing. All servicing and
future upgrading to this equipment must be carried out by personnel trained and authorized
by manufacturer.
1-1 Heyer Medical AG – VizOR 10 / 12 Operator’s Manual Rev. 2.0 – 09/11

Warning
Equipment is not suitable for use in the presence of a flammable anaesthetic mixture with air
or oxygen or nitrous oxide.
Warning
To prevent EMC effect on the monitor, the system should not be used adjacent to or stacked
with other equipment and that if adjacent or stacked use is necessary, the equipment should
be observed to verify normal operation in the configuration in which it will be used.
Warning
The user must check that equipment and accessories function safely and see that it is in
proper working condition before being used.
Warning
Alarm must be set up according to different situation of individual patient. Make sure that
audio sounds can be activated when alarm occurs.
Warning
Do not use cellular phone in the vicinity of this equipment. High level of electromagnetic
radiation emitted from such devices may result in strong interference with the monitor
performance.
Warning
Do not touch the patient, table nearby, or the equipment during defibrillation.
Warning
The equipment and devices connected to it should form an equipotential body to ensure
effective grounding.
Warning
The doctor shall consider all well-known side-effects when using the patient monitor.
Warning
There will be some risks of polluting the environment associated with the disposal of the
device and cables at the end of their useful lives. The device and accessories shall be disposed
in accordance with national laws after their useful lives. Contact your municipality to check
where you can safely dispose of old batteries.
Warning
Do not expose the system near any local heating item such as the direct radiation.

Warning
Do not use one monitor for two or more patient at the same time.
Warning
It is possible to increase leakage current when several systems are connected to the patient
simultaneously.
Warning
Monitor software is designed in a way that hazards arising from errors in the software
programmed are minimized.
Warning
Do not connect items not specified as parts of the monitor.
Warning
Vital sign monitor needs to be installed and put into service according to the EMC
information provided in the APPENDIX III

1.2 General Information

Environment:
Temperature
Working 5 to 40ºC
Transport and Storage -20 to 60ºC
Humidity 20-90 %( None condensing)
Altitude -200 to 3000m
Power Supply 90-260VAC,50/60Hz

PMAX= 75W
General instruction:
There are two different customer's option for TFT color bedside monitor, the VIZOR10 monitor
with 10''display and the VIZOR12 monitor with 12'' display .The VIZOR10 monitor can be
upgraded to VIZOR12 monitor with larger display. Depending on customer's order, the 10'' or 12''
monitor can be used.
Portable Patient Monitor (Figure 1-1) is adaptable to adult and neonatal usage. It can monitor vital
signals as ECG, Respiratory Rate, SPO2, NIBP, Dual IBP, CO2, O2, N2O, Anesthesia Agent,
Dual-TEMP and Cerebral State Index. It integrates parameter measuring modules, display and
recorder in one device, featuring in compactness, lightweight and portability. Built-in battery
facilitates transportation of patient. Large high-resolution display provides clear view of
waveforms.
The POWER switch is on the front panel ( in Figure 1-1). Three indicators for power, alarm and
battery are on the front panel of system. The green indicator lights, when the device is powered on
( in Figure 1-1). The ALARM indicator, flashes or lights when alarm occurs ( in Figure 1-1)
and The battery indicator is green, when the battery is charged otherwise it is orange. ( in Figure
1-1). The sockets of the sensors are at the left side of system. Other sockets and power plug-in are
at the back.
Warning
During the system is powered on, the indicators light. If all indicators light, it will show
proper functioning of indicators.

a. VIZOR12 Patient Monitor b. VIZOR10 Patient Monitor

Figure 1-1 bed side Monitor's picture
Portable Patient Monitor performs monitoring of:

ECG Heart Rate (HR), ST segment, PVCs/min, Arrhythmias
ECG waveforms
RESP Respiratory Rate (RR)
Respiration Waveform
SPO2 Saturation pulse oximetery (SPO2), Pulse Rate (PR)
SPO2 Plethysmogram
NIBP Systolic pressure, Diastolic pressure
, Mean arterial pressure (MAP)
TEMP Channel-1 Temperature (T1), Channel-2 Temperature (T2),
Differential temperature between two channels (DT)
IBP Channel-1 IBP (IBP1), Channel-2 IBP (IBP2),
CO2 EtCo2, FiCo2, AWRR
Multi-gas EtN2O, FiN2O, EtO2, FiO2, EtAA, FiAA
AA is included 5 anesthesia agent (DES, ISO, SEV, HAL and ENF)
CSM CSI%, BS%, SQI%, EMG%
Vital sign monitor provides extensive functions as visible & audible alarm, storage and report
printout, trend data, NIBP measurements and 80 arrhythmias event recall.
Depending on customer's order, MASIMO modules can be installed on vital sign monitor
optionally.
Depending on customer's order, mainstream or sidestream CO2 module can be installed on system
optionally.
Vital sign monitor is a user-friendly device with operations conducted by a few buttons on the front
panel and a rotary knob ( in Figure 1-1). Refer to 1.4 Button Functions for details.

1.3 Screen Display

Vital sign monitor has a color TFT display. The patient Parameters, waveforms, alarm messages,
bed number, date, system status and error messages is displayed on the screen.
The screen is divided into three areas: Header Area; Waveform Area; Parameter Area. (Figure 1-2)
Figure1-2 Monitor Main Display

Header Area:
The Header Area is at top of the screen displaying operating state of the monitor and status of the
patient.
The parameters in Header Area are bed number, type of patient (adult or neonate), current date and
time
The above messages appear on the screen throughout the monitoring process.
Other information of the Header Area comes up only with respective monitoring status.
They are:
■ indicates the remaining battery charge
■ "ALARM SILENCE" appears when the alarm silence button is pressed.
■ "NETWORK" appears when the system is connected to central system.
■ "RECORDING" appears when the system is recording.
Waveform/Menu Area:
All waveforms can be displayed at the same time. The waveforms from top to bottom are: ECG,
SpO2, IBP1, IBP2, EEG (for 12’’ or larger) and RESP/CO2/Multi-gas (coming from ECG module
or CO2 module or Multi-gas module)
Gain, filter, lead and sweep of the ECG are displayed as well .The three dotted lines from top to
bottom show the highest scale, reference scale and lowest scale of IBP waveform. These values can
be manually set.
All menus in monitor always appear at fixed areas on the screen. When the menu is displayed,
some waveforms become invisible. The size of the menu is also fixed, covering the lowest 2, 3, 4 or
5 waveforms.

Parameter Area
Parameters are displayed at a fixed position .The monitoring results are displayed in the Parameter
Area. The parameters refresh every second, except that the NIBP values refresh each time the
measurement is over.
Alarm indicator:
In normal mode, the alarm indicator is not lit.
In alarm mode, the alarm indicator lights or flashes.
Warning
Always verify the audible and visible (LED) alarms when monitor powers on.
Please refer to Chapter 3 for details.
1.4 Button Functions

All the operations to monitor are executed through buttons and knob at the right of the front panel.
The names of the buttons are above them. They are (Figure 1-3):
Power
Press to power on or off the system
Freeze
When in normal mode, press to freeze all the waveforms on the screen. When in freeze
mode, press to restore the waveform refreshing.
REC/STOP
Press to start a real time recording from ECG signal and all monitoring parameters.
Press during recording to stop it
HOME/MENU
Press to call up the HOME WINDOW. Refer to Chapter 2 HOME WINDOW
START/STOP
Press to inflate the cuff to start a blood pressure measurement. When measuring, press again
to stop the measurement and deflate the cuff.
Alarm Silence
Press to suspend alarm and disable all sound signals for 120 seconds.
("ALARM SILENCE" appears in the Header Area). Press again to restore all sound signals
and remove the message.
NOTE:
If new alarm occurs under Alarm Suspension/Silence state, Suspension/Silence state
will remove.

a. VIZOR12 Patient Monitor b. VIZOR10 Patient Monitor

Figure 1-3 bedside monitor's Buttons and Knob
Rotary Knob
This knob can be used to select and change the settings. Operations can be performed by
turning it clockwise, counter clockwise or pressing it down.
The square frame that moves with the knob turning, is referred to as "cursor".
When no menu is displayed, turning the knob clockwise can locate the cursor at: ECG, NIBP,
SPO2, IBP, EEG , and RESP/CO2/Multi gas parameter Area of screen.
When the cursor is placed at any area, the user can change the current setting. When at any of the
last items, related parameters menu can be called up for setting changes. Operation is as follows:
When you move the cursor to a certain item:
1. A menu pops up, by pressing the knob.
2. Move the cursor frame to related parameter in opened menu by turning the knob.
3. Change the content by pressing the knob on the special parameters and choose your setting and
confirm your selection by pressing it.
Warning
Before using the system on the patient, user must check the buttons function and be sure that
it is in proper working functionality as described above.

1.5 Interfaces
For the verity of operation, different kinds of interfaces are in different parts of the monitor.
At the right side is the recorder's paper inlet cover. (If the system has a recorder)
At the left side are the connectors for patient cables and the sensors, as shown in Figure 1-4.
Connector for ECG cable
Connector for Spo2 Sensor
Connector for IBP1 transducer
Connector for IBP2 transducer
Connector for NIBP cuff
Connector for TEMP1 probe
Connector for TEMP2 probe
Connector for CO2/Multi-gas sensor
a) MASIMO SPO2 b) YSI400/YSI700 Compatible

Figure 1-4 side panel
Warning
White sign of ECG connector on the side panel should be in front of the white sign of the
ECG cable connector.

This symbol means "BE CAREFUL". Refer to the manual.
Indicates that the instrument is IEC-601-1 Type CF equipment. The module with this
symbol contains an F- Type isolated (floating) patient applied part which provides a high degree of
protection against shock, and is usable during defibrillation.
Indicates that the instrument is IEC-601-1 Type BF equipment which is defibrillator proof.
The module with this symbol contains an F- Type isolated (floating) patient applied part which
contains an adequate degree of protection against shock, and is suitable for use during defibrillation
Other symbols in the monitor are explained in chapter 16.
Figure 1-5 Rear Panel
Following sockets are on the rear panel as illustrate in Figure 1-5.

■ Power Supply: 90-260 (VAC), 50/60 (Hz). (Socket )
■ VGA SLAVE MONITOR: (Socket )
Monitor interface for external standard VGA color monitor.
Working mode: 800×600,256 colors
Interface: D-sub 15 pins
Pin 1. Red Video Pin 9. NC
Pin 2. Green Video Pin 10. Ground
Pin 3. Blue Video Pin 11. NC
Pin 4. Ground Pin 12. NC
Pin 5. NC Pin 13 Horizontal Sync
Pin 6. Red Ground Pin 14. Vertical Sync.
Pin 7. Green Ground Pin 15. NC
Pin 8. Blue Ground

How to use:
1) Install the VGA slave monitor in the same room with the patient but keep it away from
the patient more than 1.5m. The monitor is intended to be used as an assistant monitoring
device.
2) Plug the connection cable while the VGA slave monitor is off.
3) Power on the monitor, same time or after power on the VGA slave monitor.
4) Adjust brightness and contrast properly.
■ (Jack )
Equipotential grounding terminal for connection with the hospital's grounding system.
■ DC INPUT (Socket )
External power supply (e.g. in ambulances)
Warning
If DC-INPUT power supply in cars like ambulances is used (ambulances with body that is
connected to the negative pole of the battery), for safety requirements, DC to DC or DC to
AC converter with the isolation of 1500VAC (at least), must be used. Using 220V of power
supply in ambulances is recommended. Preparing mentioned DC to DC or DC to AC
converter, please contact technical department of manufacturer.
■ Network Interfaces (Socket ):

The data transmission technique is full duplex and the interfacing standard is RS 422.
Warning
Patient monitor must be connected to SC1201 or SAHAND series central system only.
Warning
Use only the recommended central cable for connecting monitor to central system.
■ FUSE (Socket )
F 3A
Warning
If you are going to store the patient monitor or you don't want to use it for along time (more
than 10 days), remove the fuse or battery.

1.6 Built-in Battery

Portable Patient Monitor is equipped with a rechargeable battery. The battery will be automatically
recharged when the monitor connects to the AC INPUT .When the battery is completely
discharged, it takes about 16 hours to charge it again.
When the AC INPUT is plugged in, turning the system on or off doesn’t have any effect on the
process of charging the battery. If the battery is completely charged, the system can work about 80
minutes without connecting to the AC INPUT.
Symbol " " is displayed on the Header Area of the screen to indicate the status of recharging,
in which the yellow part represents the remaining battery charge.This symbol is only displayed
when the AC INPUT is not plugged in. If the AC INPUT is plugged in, the status of charging
battery will be shown by battery indicator at the right side of screen. When the battery indicator is
completely green, the battery if full charged and when it is orange, means that the battery is being
charged.
The battery doesn’t charge when the system connects to the DC INPUT (ambulance electricity).
The fuse on the rear panel protects the battery while charging the battery or when the system is not
connected to AC INPUT.
When the fuse is damaged, the system can not work with battery and if the AC INPUT is plugged
in, the battery indicator will be always green.
Warning
When you store the system for a long time or the system is used for the first time, you should
first place the fuse on the rear panel of monitor and then connect it to the AC INPUT for
about 24 hours. During this time you must not use the patient monitor without AC INPUT.
Warning
The monitor will shut down automatically if the battery power is low. When the electric
energy is going out, the monitor will sound beeping and display "BATTERY LOW" in the
Header Area. Connecting the monitor to the AC power at this moment can recharge the
battery while operating. If you keep on using the battery, the monitor will shut down
automatically.

Chapter 2 System Configuration

■ For last saved ECG signal, please refer to 2.1 SIGMA
■ For previous value of measured parameters, please refer to 2.2 TREND.
■ For alarm setting and a alarm volume adjustment, please refer to 2.3 ALARM
■ For date and time setting please refer to 2.4 SETUP
Portable Patient Monitor features flexible configurations. The configuration is done through
operations on the HOME WINDOW (figure 2-1), by pressing the HOME/MENU button on the
front panel of monitor
Figure 2-1 HOME WINDOW

2.1 SIGMA
Patient monitor is able to save last 160 seconds ECG signal and it is visible in 10 traces in
SIGMA WINDOW.
Pick "SIGMA" in HOME WINDOW to call up the following menu:
Figure2-2 HOME/SIGMA WINDOW

In this window there are ECG current settings, ECG LEAD, ECG GAIN and SIGMA SWEEP.
Refer to Chapter 4 ECG MONITORING for details.
2.2 TREND
The latest 72 hours trend value of parameters is recorded every 20 seconds. Pick "TREND" in
the HOME WINDOW to call up the following menu:
Figure 2-3 HOME/TREND WINDOW

Y-axis stands for related value and X-axis for time.

■ To select trend graph of a specific parameter:

Pick parameter name (the most left item) and select a requested parameter name by turning the
knob. Available options are HR, SPO2, RESP, T1, T2, IBP1, IBP2, CO2, N2O, O2, AA, PVCs
and ST.
■ To change the display scale:

Pick "SCALE" (the second left item) to adjust the Y-axis scale and thus change the trend curve
in proportion.
SCALE1 SCALE2 SCALE3 SCALE4 SCALE5 SCALE6

PARAMETER
MIN MAX MIN MIN MIN MAX MIN MAX MIN MAX MIN MAX
HR 0 60 0 120 0 240 - - - - - -
SPO2 80 100 60 100 0 100 - - - - - -
RESP 0 60 0 120 0 240 - - - - - -
T1 30 42 24 48 0 48 - - - - - -
T2 30 42 24 48 0 48 - - - - - -
IBP1 -20 50 -20 100 -20 200 -50 300 50 250 - -
IBP2 -20 50 -20 100 -20 200 -50 300 50 250 - -
AWRR 0 60 0 120 0 240 - - - - - -
CO2 0 50 0 100 - - - - - - - -
O2 0 50 0 100 - - - - - - - -
N2O 0 50 0 100 - - - - - - - -
AA 0 1.0 0 2.0 0 3.0 0 5.0 0 10.0 0 20.0
PVCs 0 20 0 50 0 100 - - - - - -
ST -0.2 0.2 -0.5 0.5 -1 +1 -2 2 - - - -
■ To select how long the trend graph is displayed:

Pick the third left item, available options are 15 min, 30 min, 1, 2, 4, 8, 16, 24,36,48,60 and 72
hours.
■ To obtain trend data of a specific time:

Cursor line in trend graph shows specific time. You can move the cursor line to change the time
by pressing the fourth left item and turning the knob, when the time interval (the third left item)
is set at 1 or 2 hours. Parameters at mentioned time are displayed on the right side of the TREND
WINDOW menu.
■ To select time interval of trend in x-axis

Pick "SHIFT"(the fifth left item) to adjust the start and stop time. By every clicking on the
SHIFT, the x scale will be changed in the extent of the specified time of the third left item.
NOTE:
If selected trend time is set more than 48 hours, the “SHIFT” key will be useless.

2-3 ALARM
Pick "ALARM" in HOME WINDOW to call up, the following menu:
Figure 2-4 HOME/ALARM WINDOW

Alarm settings are all together in this menu.
■ ALARMS ON/OFF
Pick "ON" to enable the alarm functions.
Pick "OFF" to disable the alarm functions such as audio alarm, parameters blinking and
alarm light indicator. In "OFF" mode there will be a beside all parameters. This
function changes alarm parameters ON or OFF all together, but you are able to change
every specified alarm parameters separately in its own window.
■ ALARM FREEZE
Pick "ON" to freeze all the related signals when parameter's value violates adjusted alarm
limits is activated. In freeze mode, press "Freeze" button on the front panel to release the
waveform refreshing
Pick "OFF" to disable signal freezing when alarm is activated.
■ ALARM VOLUME
Pick "ALARM VOLUME" to set the volume of alarm sound. The selection ranges from
1 to 7.
1 represents minimum volume, while 7 represents maximum volume. Rotating the knob
increases or decreases the volume.
NOTE:
All other settings in this menu are about alarm on or off and high or low limit of
monitor measurable parameters alarm ranges. You are able to set these items in
related parameters menu. Refer to modules chapters for details.

2.4 SETUP
After choosing "SETUP" in HOME WINDOW menu, the following menu will be called up:
2.5 HOME / SETUP WINDOW
CALENDAR available options are "SOLAR" and "CHRISTIAN".

DATE set the current date of monitoring.
TIME set the current time of monitoring.
BED NUMBER patient bed number (1..99).
ADULT/NEONATE available options are "ADULT" and "NEONATE".
LANGUAGE available options are “ENGLISH”, ”SPANISH”
,”ITALIAN” ,”FRENCH”, ”RUSSIAN”,”TORKISH”,
” GERMAN” and “POLISH”.
LARGE DISPLAY available options are “PAGE1”, “PAGE2” and “OFF”.
DISPLAY OFF display off, until a button is pressed or an alarm occurs.
LOAD DEFAULT pick it to call up the following menu:
2.6 SETUP / DEFAULT WINDOW
If you choose any options in this window, the system will load the factory settings of related
parameters. (Refer to appendix I for factory settings of parameters (default)). Because of
changing all your previous settings, the system asks if you are sure to change all by this message:
ECG SETTING WILL BE DEFAULT, ARE YOU SURE?

YES NO

CLEAR MEMORY
You can clear stored parameters in system such as parameters saved in TREND window, NIBP
LIST window, CSM TREND window and ARR EVENT LIST window.
For each separate window, a message will appear on the screen which asks you whether to clear
that item or not. These messages are as a follow:
TREND WILL BE CLEARED, ARE YOU SURE?
YES NO”
NIBP LIST WILL BE CLEARED, ARE YOU SURE?

YES NO”
CSM TREND WILL BE CLEARED, ARE YOU SURE?

YES NO”
ARR LIST WILL BE CLEARED, ARE YOU SURE?

YES NO”
2.5 PATIENT INFORMATION
After choosing "PATIENT INFORMATION" in HOME WINDOW menu, the following menu
will be called up:
2-7 HOME/PATIENT INFORMATION WINDOW

Press "NEW" to enter new patient information, All patient information will be cleared after some
confirmation questions.
Press "EDIT" to edit current patient information.
The information menu is as a follow:
2-8 HOME/PATIENT INFORMATION WINDOW

NAME Patient name (length: 15 characters)
PATIENT ID Hospital ID for patient (length: 15 characters)
BIRTH DATE Date of the birth
GENDER Available options are MALE and FEMALE
WEIGHT Available between 0.5 to 300 Kg
HEIGHT Available between 10 to 300 cm
DR. NAME Doctor name (length: 10 characters)
HOSPITAL Hospital name (length: 15 characters)
WARD Hospital ward name (length: 10 characters)

2.6 RECORDER
After choosing "RECORDER" in HOME WINDOW menu, the following menu will be called
up:
2-9 HOME/RECORDER WINDOW

■ INTERNAL RECORDER
Pick "ON" to enable internal recorder and record via it.
Pick "OFF" to disable the internal recorder and record via central system
■ TRACE1
Choose the first trace of print out record while manual recording.
Available options are ECG, SPO2, IBP1, IBP2, RESP and OFF
■ TRACE2
Choose the second trace of print out record while manual recording.
Available options are ECG, SPO2, IBP1, IBP2, RESP and OFF.
■ RECORDER SWEEP
Available options for RECORDER SWEEP are 12.5, 25 and 50 mm/s.
■ MANUAL RECORD TIME

Available options for MANUAL RECORD TIME are "MANUAL" and
"CONTINUOUS".
■ PERIODIC TRACE1
Choose the first trace of print out record while automatic recording.
Available options are ECG, SPO2, IBP1, IBP2, RESP and OFF
■ PERIODIC TRACE2
Choose the second trace channel of print out record while automatic recording.
Available options are ECG, SPO2, IBP1, IBP2, RESP and OFF.
■ PERIODIC INTERVAL
For choosing interval time in periodic recording mode . Available selections are 15min,
30min,1h,2h,4h,8h,12h,24h and OFF.
■ ALARM RECORD
While alarm recording for each parameter is set ON, it automatically starts recording when
alarms happened.

2.7 ABOUT
After choosing "ABOUT" in HOME WINDOW menu, the following menu will be called up:
2-10 HOME/ABOUT WINDOW

Chapter 3 Alarm
This chapter gives general information about alarm and corresponding functions.
Warning
Always verify the audible and visible alarms when monitor is powered on.
3.1 Alarm Modes

3.1.1 Alarm Level and Setup
Portable Patient Monitor offers three levels of alarm.
Level I alarm indicates the patient's life is in danger or the monitor under use has serious
problems. It is the most serious alarm.
Level II alarm means serious warning.
Level III alarm is a general warning.
Patient monitor has preset the alarm level for the parameters. You can also modify the
classification using the method described in module's chapters.
3.1.2 Alarm Modes
Alarm messages will be prompted through screen, indicator, and sound according to different
levels.
Screen Display
When an alarm occurs, the parameter which triggers the alarm, blinks.
Alarm Indicator
Alarm indicator flashes red for Level I alarm, yellow for Level II alarm and lights yellow for
Level III alarm.
Alarm Sound
Corresponding alarm, sound will be activated, if the alarm is not silent (i.e., the SILENCE button
has not been pressed to make SILENCE state). The sounds of the alarm for the three levels are
different:
Level I alarm sounds "DO-DO-DO--DO-DO" twice every 10 seconds;
Level II alarm sounds "DO- DO-DO" every 25 seconds;
Level III alarm sounds "DO-" every 50 seconds.
NOTE:
When alarms of different levels occur at the same time, the monitor prompts the
alarm of the highest level.

3.1.3 Alarm verification during power on
During the monitor is being powered on, audible and visible (yellow and red indicator) alarms
will be self tested.
Every time that monitor is powered on, the system beeps, and yellow and red indicator light
about 2.5 seconds separately. If no beeps heard or no alarm indicator is lighted, do not use this
device to monitor any patient, and notify After Sales Service.
3.2 Alarm Cause

Alarm occurs when alarm for parameter is evoked;
Conditions that activate the parameter alarms:

When the measurement value exceeds the adjusted alarm limits and the alarm is in "ON" mode.
If the monitor detects situations like ASYSTOLE or APNEA, alarm occurs.
Alarm will not activate if the alarm is in "OFF" mode.
3.3 Alarm Silence Button Function

Pressing the "Alarm Silence" button once can suspend all alarm sounds for 2 minutes. Message
"ALARM SILENCE" prompts in the Header Area for 120 seconds. During the 2 minutes if new
alarm occurs, the Silence status will be terminated and both audible and visible alarms are
triggered. If within the 2 minutes of alarm suspension the operator presses "Alarm Silence"
button, the alarm suspension status will be ended and the normal alarm status resumed
immediately.
3.4 Parameter Alarm

The setup of the alarm parameters can be found in related menus separately. In the menu for a
specific parameter, you can check and set the alarm limit and the alarm status.
When a parameter alarm is 'OFF', this symbol" " is displayed near the parameter.
For the parameters of which alarm is set to 'ON', the alarm will be triggered when at least one of
them exceeds the alarm limits. The following actions take place:
1. Alarm message is displayed on the screen.

2. The monitor beeps in its corresponding alarm level and volume.
3. Alarm indicator flashes.

3.5 When an Alarm Occurs

It is needed to identify the alarm and act appropriately according to the cause of the alarm.
1. Check the patient's condition.

2. Identify the module in alarm.
3. Identify the cause of alarm.
4. Silence the alarm, if necessary.
5. When cause of alarm has been over, check that the alarm is working properly.
You will find the alarm messages for the individual parameters in each module's chapter.

Chapter 4 ECG Monitoring

4.1 GENERAL
Monitoring the ECG produces a continuous waveform of the patient's cardiac electric activity for
an accurate assessment of his current physiological state. The process of depolarization and
repolarization of the myocardium generates electric potential that are sensed by ECG electrodes
on the skin. These electrodes are typically attached to the patient's right arm, left arm and left leg
for 3 leads monitoring. The monitor processes and amplifies these signals and presents the ECG
waveform on the screen. Only proper connection of the ECG cables can ensure satisfactory
measurement.
- It takes about 6 seconds to change heart rate from 80 to 120 bpm. (Test method is according to
AAMI standard EC13:1993)
- It takes about 8 seconds to change heart rate from 80 to 40 bpm. (Test method is according to
AAMI standard EC13:1993)
- When Tachycardia (200 bpm HR) happens, it takes 6 seconds to alarm. In this case the low
alarm limit should be set in 60 bpm and high alarm limit on 100 bpm.
- It takes 10 seconds to alarm after cardiac arrest (from 80 bpm to 0 bpm).
NOTE:
The above results are according to HR average of 4 seconds.
- The ECG monitoring is able to reject 1.2 mV TALL-T.
- The current that is applied to the patient for lead-sensing is 90nA.
- Active noise suppression specification:

The common noise signal with maximum inverse current amplitude of 10µA is delivered to the
reference lead.
- The ECG patient cable consists of 2 parts: The cable that is connected to the monitor and the
lead set that is connected to the patient.
Warning
Do not touch the patient, bed, table nearby or the monitor during defibrillation.
Warning
Use only the recommended manufacturer ECG cable for monitoring. Other ECG cables
and leads may cause improper performance and/or provide inadequate protection during
defibrillation

Warning
Line Isolation Monitor (LIM) transient may resemble actual cardiac waveforms and thus
inhibit heart rate alarms. Such transients may be minimized by proper electrode and cable
placement, as specified in this manual .
Warning
When you connect the cables and electrodes, make sure that no metal part is in contact
with the safety ground. Verify that all ECG electrodes are correctly attached to the patient.
NOTE:
Interference from a non-grounded instrument near the patient and/or ESU (Electro
Surgical Unit) interference can cause inaccuracy of the waveform.
1. Prepare the patient's skin prior to place the electrodes.
■ The skin is a poor conductor of electricity, therefore preparation of the patient's skin is
important to facilitate good electrode contact to skin.
■ Shave hair from sites, if necessary.
■ Wash sites thoroughly with soap and water. (Never use ether or pure alcohol, because
increases skin impedance).
■ Rub the skin briskly to increase capillary blood flow in the tissues and remove skin
grease.
2. Put the electrodes on the patient. (Figure 4-1, 4-2) Before attaching, apply some conductive
jelly on the electrodes if the electrodes are not self-supplied electrolyte.
3. Attach clip or snap to electrodes prior to placement.
Warning
Use only one type of electrode on the same patient to avoid variations in electrical
resistance. For ECG monitoring, it is recommended to use silver/silver chloride electrode.
When dissimilar metal are used for different electrodes, the electrodes may cause large
offset potentials due to polarization, which may be severe enough to prevent obtaining an
ECG trace. Using dissimilar metals may also increase recovery time after defibrillation.
ECG electrodes placement for monitoring
Figure 4-1 ECG 3-lead placement

Electrode placement for 3 lead set (figure 4-1)

Right Arm (RA): red electrode, be placed near the right shoulder, directly below the clavicle.
Left Arm (LA): yellow electrode, be placed near the left shoulder, directly below the clavicle.
Left Arm (LL): green electrode, be placed on the left hypogastrium.
Figure 4-2 ECG 5-lead placement
Electrode placement for 5 lead set (figure 4-2)

Right Arm (RA): red electrode, be placed near the right shoulder, directly below the clavicle.
Left Arm (LA) : yellow electrode, be placed near the left shoulder, directly below the clavicle.
Chest (C) : white electrode, be placed on the chest as illustrated in figure 4-2
Right Leg (RL) : black electrode, be placed on the right hypogastrium.
Left Leg (LL) : green electrode, be placed on the left hypogastrium.
NOTE:
To ensure patient safety, all leads must be attached to the patient.
For 5-lead set, attach the C-electrode to one of the indicated positions as below (Figure 4-3)
● V1 on 4th intercostal space at the right sterna margin.
● V2 on 4th intercostal space at the left sterna margin.
● V3 midway between V2 and V4 electrodes.
● V4 on the 5th intercostal space at the left clavicular line.
● V5 on the left anterior axillary line, horizontal with V4 electrode.
● V6 on the left middle axillary line, horizontal with V4 electrode.
● V3R-V6R on the right side of the chest in positions corresponding to those on the left.
● VE over the xiphoid position.
For posterior C lead placement, place the C electrode at one of the following locations.
● V7 on the 5th intercostal space at the left posterior axillary line of back.
● V7R on the 5th intercostal space at the right posterior axillary line of back

Figure 4-3 C-electrode placement for 5-lead set
Depending on lead type (3 leads or 5 leads), you can choose different lead I, II, III, aVR, aVL,
aVF, V.
Figure 4-4 ECG lead
Warning
Check everyday whether there is skin irritation resulted from the ECG electrodes. If so,
replace electrodes every 24 hours or change their sites.
Warning
Verify lead fault detection prior to the start of monitoring phase. Unplug the ECG cable
from the socket, the screen will display the error message "ECG NO CABLE"

Warning
When using Electrosurgery equipment, leads should be placed in a position in equal
distance from Electrosurgery electrotome and the grounding plate to avoid cautery.
Electrosurgery equipment wire and ECG cable must not be tangled up.
The placing of the ECG leads will depend on the type of surgery that is being performed. For
example, with open chest surgery the electrodes may be placed laterally on the chest or on the
back. In the operating room, artifacts can sometimes affect the ECG waveform due to the use of
ESU (Electro Surgical Unit). To reduce this effect, you can place the electrodes on the right and
left shoulders and on the left side of hypogastrium. Avoid placing the electrodes on the upper
arms; otherwise the ECG waveform will be too weak.
Warning
When using ESU, never place an electrode near the grounding plate of the Electrosurgery
device, otherwise there will be a great deal of interference with the ECG signal.
Warning
It is possible for the patient to be burnt due to an improper connection of the natural
electrode of ESU.
Warning
ECG cable may be damaged if they are connected to a patient during defibrillation. Cables
that have been connected to a patient during defibrillation should be checked for
functionality before being used again.
NOTE:
If an ECG waveform is not accurate while the electrodes are tightly attached, try to
change the lead.
NOTE:
Interference from a non-grounded instrument near the patient and/or ESU
interference can cause inaccuracy of the waveform.

Normal QRS complex is:
■ Tall and narrow with no notches.

■ With tall R-wave completely above or below the baseline
■ With T -wave less than one-third of the R-wave height.
■ With P-wave much smaller than the T -wave.
Figure 4-5 standard ECG Waveform
Warning
Do not touch the patient, table nearby, bed or the equipment during defibrillation.
Warning
Do not immerse ECG leads completely in water, solvents or cleaning solutions because the
connectors are not waterproof. Do not sterilize ECG cable by irradiation, steam, or
ethylene oxide.
Warning
For the patients with pacemaker, the monitor may continue to count the pacemaker rate
during occurrences of cardiac arrest or some arrhythmias. Do not rely entirely upon
monitor alarms. Keep the patients with pacemaker under close surveillance.
4.2 ECG WINDOW

Pick ECG, the following menu will pop up:
Figure 4-6 ECG WINDOW

■ ECG LEAD: by pressing ECG LEAD, the following menu will pop up:
Figure 4-7 ECG / LEAD WINDOW
• ECG TRACE: You can choose following lead for trace 1 to 4:

"І" to count the heart rate and show RA-LA waveform
"ІІ" to count the heart rate and show RA-LL waveform
"ІІІ" to count the heart rate and show LA-LL waveform
LA + LL
"aVR" to count the heart rate and show RA- waveform
2
RA + LL
"aVL" to count the heart rate and show LA- waveform
2
RA + LA
"aVF" to count the heart rate and show LL- waveform
2
RA + LA + LL
"V" to count the heart rate and show C- waveform
3
(You can choose aVR, aVL, aVF, V just when ECG is in 5 lead mode).
• CABLE TYPE
To adjust ECG measurement mode to "3 WIRES" or "5 WIRES ".
• DISPLAY FORMAT
When monitoring with "5 LEAD", in the ECG / LEAD window set the display format to:
Cascade: the ECG waveform area shows 1 waveform.
2 trace: the ECG waveform area shows 2 waveform.
4 trace: the ECG waveform area shows 4 waveform.
When monitoring with "3 LEAD", only cascade is applicable.
■ ECG GAIN
To adjust the size of ECG waveforms, select gain value for each lead from
×0.25,×0.5,×1,×2, ×4 and AUTO.
In "AUTO" mode, the monitor chooses an appropriate level automatically.
■ ECG SWEEP
Available options for ECG SWEEP are 12.5, 25, and 50 mm/s.

■ ECG FILTER
For clearer and more detailed waveform
FILTER TYPE FREQUENCY RANGES APPLICATION
NORMAL 0.5-40HZ In normal use
In diagnostic application. but the
EXTENDED 0.05-100HZ ECG waveform might have some
noises
This mode may reduce perturbance
and Interference from
MONITOR 0.5-28HZ Electrosurgery equipment or when
the system has high noises or
doesn't have equipotential earth
■ HR AVERAGE
Available options for HR AVERAGE are 4, 8 and 16 sec.
■ HR SOURCE
Heart rate may be drived by “ECG”, “SPO2”,“IBP1” or “IBP2”. In AUTO mode Patient
monitor automatically derives heart rate from ECG whenever a valid ECG signal is
present. If ECG is not present, depending on priority of SPO2 , IBP1 and IBP2 , the heart
rate value is derived from every signal that is being monitored.
NOTE:
Driving HR from IBP signal is possible just in ART, PAP, RVP, LVP and IBP
labels.
NOTE:
Driving HR from IBP signal is possible just in ART, PAP, RVP, LVP and IBP
labels.
NOTE:
If “HR SOURCE” is “ON” and IBP cable is not connected to the system, HR value
will not displayed.
NOTE:
Driving HR value from IBP signal is not possible in the following condition and the
HR value will be “---“:
- “IBP1/IBP2 STATIC PRESSURE” message on the display
- “IBP1/IBP2 SEARCH” message on the display
- HR value less than 25
- Selecting IBP, ART, PAP, RVP and LVP label.
NOTE:
HR value measurement range is 25 ~250bpm, when the HR is derived from IBP
signal.

■ BEAT VOLUME
Range: 1-7;"OFF" indicates silence, while 7 indicates maximum volume.
■ PACE DETECT
"ON" for patient with pacemaker," OFF" for patient without pacemaker.
When it is "ON","PACE: ON" will be displayed on the screen.
When PACE DETECT is "ON", the system ECG monitoring detects and rejects pacemaker-
generated signals from ECG signal so that they will be ignored in determining heart rate.
Detected pacemaker signals will be marked on the ECG waveform as 1 centimeter spike.
Monitoring of patients with pacemaker is not generally affected when PACE DETECT is enable.
However, in some instances if the patient does not have a pacemaker, it may be desirable to turn
the detection function OFF so that artifacts in the waveform will not be mistaken for a
pacemaker signal.
Warning
For patient with pacemaker, the PACE DETECT function must be switched "ON",
otherwise, the pacing impulse may be counted as normal QRS complex.
■ ECG CALIB
"ON", 1mV calibrated ECG wave will be displayed. When it is "ON", the calibration
waveform will display until closing the ECG WINDOW or turning the rotary switch..
■ ALARM
Pick "ALARM" in ECG WINDOW to call up the following menu:
Figure 4-7 ECG/ALARM WINDOW
● ALARM LEVEL
Selectable between 1,2. Level 1 represents the most serious case.
● HR ALARM
Pick "ON" to enable alarm functions such as parameters blinking, audio alarm and light
indicator. Pick "OFF" to disable the alarm functions and there will be a " " symbol
instead of alarm limits in Parameters Area.
● HR LIMIT
ECG alarm is activated when the heart rate exceeds adjusted ALARM HIGH value or
falls below adjusted ALARM LOW value.(min:30 and max:250)

■ ARR ANALYSIS
Pick "ARR ANALYSIS" in ECG WINDOW to call up the window for arrhythmia analysis
setting. This monitor is able to detect up to 12 types of arrhythmia. Refer to
chapter 14 ARR MONITORING for complete description of arrhythmia analysis in the
system.
■ ST ANALYSIS
Pick "ST ANALYSIS" in ECG WINDOW to call up the window for ST analysis setting. The
system is able to monitor ST segment deviation. Refer to chapter 13 ST MONITORING for
complete description of ST analysis in the system.
4.3 ECG Alarm Messages

Alarm sounds when:
1. The heart rate exceeds adjusted alarm limits, and/or,
2. The ECG ASYSTOLE
Alarm Situation Visual prompts Audio sound
Heart rate violates adjusted ●HR value blinks.
Heart rate alarm Activated
alarm limits ●Alarm indicator flashes.
●HR is "00" and blinks
ECG Heart beat is not detected in ●"ECG ASYSTOLE" is
Activated
ASYSTOLE last 10 seconds. displayed.
●Alarm indicator flashes.

ECG messages include:

Message cause solution explanation
Alarm level 3, Pressing ALARM
ECG NO ECG cable is not SILENCE, alarm will be disable and
Connect ECG cable
CABLE connected to the system ignore this fault.
Check for any possible sources of Alarm level 3, Pressing ALARM

signal noise form the area around the SILENCE, alarm will be disable and
ECG signal is noisy or
ECG NOISE cable and electrode, and check the ignore this fault.
saturated.
patient for great motion and also check
the lead wires.
Reference lead or more
ECG CHECK Make sure that all electrodes and SILENCE, alarm will be disable and
than one chest lead is
LEADS patient cable are properly connected ignore this fault.
not properly connected.

ECG CHECK Mentioned leads are not Make sure that mentioned electrode is
SILENCE, alarm will be disable and
LA,RA,LL properly connected. properly connected
ignore this fault.
ECG amplitude is
ECG SIGNAL
lower than standard Check the situation of the chest leads
WEAK
limit
Power off and then on the system .If
this message is displayed again the
ECG DEFECT ECG module failure SILENCE, alarm will be disable and
user should contact local After Sale
ignore this fault.
Service.
RL or other leads are Alarm level 2, Pressing ALARM
CHECK RL not properly connected Make sure that all electrodes and SILENCE, alarm will be disable and
OR ALL when ECG lead is V, patient cable are properly connected ignore this fault.
aVR, aVF or aVR.
LL or other leads are Alarm level 2, Pressing ALARM
CHECK LL OR Make sure that all electrodes and
not properly connected SILENCE, alarm will be disable and
ALL patient cable are properly connected
when ECG lead is I ignore this fault.
LA or other leads are Alarm level 2, Pressing ALARM
CHECK LA OR Make sure that all electrodes and
when ECG lead is II ignore this fault.
RA or other leads are Alarm level 2, Pressing ALARM
CHECK RA OR Make sure that all electrodes and
when ECG lead is III ignore this fault.
Last 4 messages in the table are just for 5 lead mode.

After checking the mentioned solution, if above mentioned messages are displayed again, the
ECG cable may be damaged and you should contact with local After Sales Services.

4.4 ECG CABLE CLEANING

If there is any sign indicating that the ECG cable may be damaged or deteriorated, replace it with
a new one instead of continuing its application on the patient.
■ Cleaning
Use soft cloth moistened in mild soap liquid or cleaning agent containing 70% ethanol to
clean the ECG cable.
■ Sterilization
To avoid extended damage to the equipment, sterilization is only recommended when
stipulated as necessary in the Hospital Maintenance Schedule. Sterilization facilities
should be cleaned first.
It is recommended to use 70% alcohol or isopropanol 70% as sterilization material.
■ Disinfection
To avoid extended damage to the equipment, disinfection is only recommended when
stipulated as necessary in the Hospital Maintenance Schedule. Disinfection facilities
should be cleaned first.

5 RESP Monitoring
5.1 GENERAL
The monitor measures respiration from the amount of thoracic impedance between two ECG
electrodes (RA-LL, RA-LA). The change of impedance between the two electrodes, (due to the
thoracic movement), produces a respiratory waveform on the screen.
The signal with frequency greater than 62.5KHZ is applied to the patient for respiration
measurement.
For RESP monitoring, it is not necessary for additional electrodes, however, place of electrodes
is important.
Some patients, due to their clinical condition, expand their chest laterally, causing a negative
intrathoracic pressure. In these cases it is better to place the two RESP electrodes laterally in the
right axillary and left lateral chest areas at the maximum point of breathing movement to
optimize the respiratory waveform.
NOTE:
The RESP monitoring is not recommended to be used on patients, who are very active,
as this can cause false alarms.
Checklist for RESP Monitoring

1. Prepare the patient's skin prior to placing the electrodes.
2. Attach the electrodes to the patient and attach snap or clip to the electrodes.
3. Switch on the monitor.
NOTE:
Place the red and green electrodes diagonally to optimize the respiration waveform.
Avoid the liver area and the ventricles of the heart in the line between the RESP
electrodes to prevent cardiac overlay or artifacts from pulsating blood flow. This is
particularly important for neonates.
5.2 RESP WINDOW

Pick RESP to call up the following menu:
Figure 5-1 RESP WINDOW

■ RESP LEAD
Available options for RESP LEAD are "RA-LA" and "RA-LL"
■ RESP GAIN
To adjust the size of ECG waveforms, Select gain value for each channel from
×0.25,×0.5,×1, ×2 and ×4 .
■ RESP SWEEP
Available options for RESP SWEEP are 3,6, 12/5, and 25 mm/s.
■ ALARM LEVEL
Selectable between 1 and 2. Level 1 represents the most serious case.
■ RR ALARM
Pick "ON" to enable RESP alarm functions such as parameters blinking, audio alarm and
light indicator.Pick "OFF" to disable the alarm functions, and there will be a" "symbol
■ RR LIMIT
RESP alarm is activated when the respiration rate exceeds adjusted ALARM HIGH value or
falls below adjusted ALARM LOW value. (min:5 and max:150)
■ APNEA LIMIT
To set the standard of judging an apnea case. It ranges from 10 to 40 seconds, increases/
decreases by 5s.
■ CAPNO/RESP
To select “RESP” or “CAPNO” module for measuring respiratory rates. Available options
are “RESP” and “CAPNO”. In “RESP” mode, CAPNO module is set to Standby mode and
RESP parameters and waveform are displayed.

5.3 RESP Alarm Message

Alarm is activated when the respiration rate exceeds adjusted alarm limits.
Alarm Situation Visual prompt Audio sound

Respiration rate violates ●RESP value blinks
RR Alarm Activated
adjusted alarm limits ●Alarm indicator flashes.
Non-respiration condition ●Alarm indicator flashes
APNEA Activated
overruns adjusted time ●"RESP APNEA" blinks
RESP messages include:
message Cause solution explanation

alarm level 3,The message is blinking
Alarm is activated when RR ALARM
RESP CHECK The RESP leads are not Make sure that all electrodes,
is "ON". Pressing ALARM
LEADS properly connected. lead are properly connected
SILENCE, alarm will be disable and
ignore this fault.

6 SPO2 Monitoring
6.1 GENERAL
What does it measure?
SPO2 Plethysmogram measurement is employed to determine the oxygen saturation of
hemoglobin in the arterial blood. If, for example, 97% hemoglobin molecules in the red blood
cells of the arterial blood combine with oxygen, then the blood has a SPO2 oxygen saturation of
97%. The SPO2 value on the monitor will be 97%. The SPO2 value shows the percentage of
hemoglobin molecules which have combined with oxygen molecules to form oxyhemoglobin.
The SPO2 module can also provide a pulse rate signal .
Operating Principals
Masimo module
The Masimo SET MS-7 pulse oximeter is based on three principles:
1 Oxyhemoglobin and deoxyhemoglobin differ in their absorption of red and infrared

light (spectrophotometry).
2. The volume of arterial blood in tissue and the light absorbed by the blood changes
during the pulse (plethysmography).
3. Arterio-venous shunting is highly variable and that fluctuating absorbance by venous

blood is a major component of noise during the pulse.
The Masimo SET MS-7 pulse oximeter as well as traditional pulse oximetry determines SpO2 by
passing red and infrared light into a capillary bed and measuring changes in light absorption
during the pulsatile cycle. Red and infrared light-emitting diodes (LEDs) in oximetry sensors
serve as the light sources, a photodiode serves as the photodetector.
Traditional pulse oximetry assumes that all pulsations in the light absorbance signal are caused
by oscillations in the arterial blood volume. This assumes that the blood flow in the region of the
sensor passes entirely through the capillary bed rather than through any arterio-venous shunts.
The traditional pulse oximeter calculates the ratio of pulsatile absorbance (AC) to the mean
absorbance (DC) at each of two wavelengths, 660 nm and" 905 nm:
S (660) = AC (660)/DC (660)
S (905) = AC (905)/DC (905)

The oximeter then calculates the ratio of these two arterial pulse-added absorbance
signals:
R= S (660)/S (905)
This value of R is used to find the saturation SpO2 in a look-up table built into the oximeter's
software. The values in the look-up table are based upon human blood studies against a
laboratory co-oximeter on healthy adult volunteers in induced hypoxia studies.

The Masimo SET MS-7 pulse oximeter assumes that arterio-venous shunting is highly variable
and that fluctuating absorbance by venous blood is the major component of noise during the
pulse. MS-7 decomposes S (660) and S (905) into an arterial signal plus a noise component and
calculates the ratio of the arterial signals without the noise:
S (660) = S1 + N1
S (905) = S2 + N2
R= S1/S2
Again, R is the ratio of two arterial pulse-added absorbance signals and its value is used to find
the saturation SpO2 in an empirically derived equation into the oximeter's software. The values
in the empirically derived equation are based upon human blood studies against a laboratory
co-oximeter on healthy adult volunteers in induced hypoxia studies.
The above equations are combined and a noise reference (N') is determined:
N' =S (660) - S (905) × R
If there is no noise N' = 0: then S (660) = S (905) × R which is the same relationship for the
traditional pulse oximeter.
The equation for the noise reference is based on the value of R, the :value being seeked to
determine the SpO2. The MS-7 software sweeps through possible values of R that correspond to
SpO2 values between 1% and. 100% and generates an N' value for each of these R values. The S
(660) and S (905) signals are processed with each possible N' noise reference through an
adaptive correlation canceller (ACC) which yields an output power for each possible value of R
(i.e., each possible SpO2 from 1% to 100%). The result is a Discrete Saturation Transform
(DSTTM) plot of relative output power versus possible SpO2 value as shown in the following
figure where R corresponds to SpO2 = 97%:
Figure 6-1 MASIMO Energy output

The DST plot has two peaks: the peak corresponding to the higher saturation is selected as the
SpO2 value. This entire sequence is repeated once every two seconds on the most recent four
seconds of raw data. The MS'-7 SpO2 therefore corresponds to a running average of arterial
hemoglobin saturation that is updated every two seconds.
NOTE:
A pulseoximetry is a early warning device .Use lab co-oximeter to understand the
patient's condition completely.
NOTE:
Assessment of pulse oximeter probe or a pulse oximeter monitor accuracy can not
be done with simulators and functional testers.
Warning
Use only the recommended manufacturer SPO2 sensor for monitoring .Other SPO2
sensors may cause improper monitor performance.
Warning
Regarding the selected module, use accessories specified for each spo2 module (refer to
chapter 20)
Warning
While choosing sensor, consider sensor direction for use, written on the package such as
patient's age and weight or if the sensor is reusable or disposable.
Warning
Pulseoximetry can overestimate the SPO2 value in the presence of Hb-CO, Met-Hb or dye
dilution chemicals.
Warning
ESU wire and SPO2 cable must not be tangled up.
Warning
Do not use the sensor on extremities with arterial catheter or venous syringe.
Warning
High ambient light sources such as surgical lights (especially those with a xenon light
source), bilirubin lamps, fluorescent lights, infrared heating lamps and direct sunlight can
interfere with the performance of an SPO2 sensor .to prevent interference from ambient
light, ensure that the sensor is properly applied .and cover the sensor site with opaque
material. Failure to take this action in high ambient light conditions may result in
inaccurate measurements.

NOTE:
SPO2 module updates SPO2 and pulse rate values every 1 sec.
NOTE:
Do not perform SPO2 and NIBP measuring in same arm at simultaneously; because
obstruction of blood flow during NIBP measuring may adversely affect the SPO2
value.
SPO2 Measuring Range 0 - 100 %

SPO2 Alarm Rang 20 - 100 %
SPO2 Accuracy 70% - 100% 2%
50% - 70% 3%
Pulse Rate Measuring Range 25-240 bpm
Materials used in our SPO2 sensors are innoxious.
SPO2 measurement:
1. Turn on the monitor.
2. Attach the sensor to the appropriate site of the patient finger. Refer to Figure 6-2 for the
proper method.
3. Plug the connector of the sensor extension cable into the SPO2 socket on the left side of
the device.
Figure 6-2 placing the SPO2 sensor

NOTE:
● Make sure the nail covers the light window.
● The wire should be on the backside of the hand.
NOTE:
SPO2 value always displays at the same position. Pulse Rate will display instead of
HR value when "HR SOURCE" is set at "SPO2" in the ECG WINDOW menu and
will be displayed near SPO2 when “SPO2 PULSE RATE” is set “ON” in the SPO2
WINDOWmenu.
Warning
Verify sensor cable fault detection before beginning of monitoring phase. Unplug the SPO2
sensor cable from the socket, the screen will display the error message "SPO2 NO PROBE"
Warning
Do not use the sterile supplied SPO2 sensors if the packaging or the sensor is damaged and
return them to the vendor.

Warning
Measurement limitations
In operation, the accuracy of oximetry measurement can be affected by:
● High-frequency electrosurgical interference and defibrillation.
● Excessive patient movement.
● Injection of intravascular dye such as indocyanine green or methylen blue.
● Significant concentrations of dysfunctional hemoglobin, such as carboxyhemoglobin
and methemoglobin
● Sensor temperature (maintain between 28° C and 42° C for best operation)
● External illumination more than 5,000 lumens/square meter (typical office lighting)
● Improper sensor application.
● Venous pulsations
● Cabling entanglement or strangulation
● Placement of the sensor on an extremity that has a blood pressure cuff, arterial
catheter, or intravascular line
● Do not use oximeters and oximetry sensors during magnetic resonance imaging
(MRI) scanning. Induced current could potentially cause burns.
Warning
Prolonged and continuous monitoring may increase jeopardy of unexpected change of
dermal condition such as abnormal sensitivity, vesicle, repressive putrescence, and so on. It
is especially important to check the sensor placement of neonate and patient of poor
perfusion or immature dermogram by light collimation and proper attaching strictly
according to changes of the skin. Check per 2-3 hours the sensor placement and move it
when the skin deteriorates. More frequent examinations may be required for different
patients.
Warning
Tissue damage or inaccurate measurement can be caused by incorrect application or use of
an SPO2 sensor, for example by wrapping the sensor too tightly or by applying
supplemental tape.
Warning
Loss of pulse signal can occur when
● The patient is in cardiac arrest or in shock.
● The patient has hypotension, severe vasoconstriction, severe anemia, or hypothermia.
● There is arterial occlusion proximal to the sensor.
Warning
Do not immerse sensor and patient cable completely in water, solvents, or cleaning
solutions because the sensor and patient cable are not waterproof.

6.2 SPO2 WINDOW

The SPO2 WINDOW menu is as follows:
Figure 6-3 SPO2 WINDOW
■ SPO2 RESPONSE
Available options for SPO2 RESPONSE are "SLOW","NORMAL" and "FAST"
SLOW : least affected by patient motion. User must be aware that changes in SPO2 are
reported more slowly comparing to other modes.
Normal : recommended for most clinical situations
Fast : useful for special application such as sleep studies in which the user desired
fast response mostly affected by patient motion.
■ SPO2 PLETH SWEEP

Available options for SPO2 PLETH SWEEP are 12.5 and 25 mm/s.
■ ALARM LEVEL
■ SPO2 ALARM
Pick "ON" to enable SPO2 alarm functions such as parameters blinking, audio alarm, and
light indicator.Pick "OFF" to disable the alarm functions and there will be a" "symbol
■ SPO2 LIMIT
SPO2 alarm is activated when the SPO2 exceeds adjusted ALARM HIGH value or falls
below adjusted ALARM LOW value. (min: 20 and max:100)

■ SPO2 SENSITIVITY (MASIMO MODULE)

Available options for SPO2 SENSITIVITY are NORMAL, MAX and APOD.
NORMAL: The perfusion threshold has different limits as the perfusion calculation is
data dependent .Specially; there is an intelligent algorithm which adjusts the low
perfusion limit in accordance with the quality of the incoming plethysmography
waveform between 0.50% and 0.02%. This mode provides the best combination of
sensitivity and probe-off detection performance. This mode is recommended for the
majority of patients.
MAX: Recognizing that some clinicians may want the absolute low perfusion
performance (0.02%) all of the time and may be willing to sacrifice sensor off detection,
Masimo provides a maximized sensitivity mode. This mode should be used for the
sickest patients, where obtaining a reading is most difficult. Maximum Sensitivity is
designed to interpret and display data for even the weakest of signals. This mode is
recommended during procedures and when clinician and patient contact is continuous.
In MAX mode, the message "SPO2 MAX SENS." displays on the screen with yellow
colour.
APOD (Adaptive Probe Off Detection): This mode is the least sensitive in picking up a
reading on patients with low perfusion but has the best detection for probe-off conditions.
This mode is useful for patients that are at particular risk of the sensor becoming
detached (pediatric, combative, etc.) By selecting this mode, “SPO2 APOD MODE”
appears on the screen.
■ SPO2 PULSE RATE

Pick “ON” to enable showing HR and SPO2 value simultaneously. If there is high quality
ECG signal and HR SOURCE is in “AUTO” mode, PR value is displayed next to SPO2
value, Otherwise, (no suitable ECG signal) HR is measured from SPO2 signal and PR
value is displayed instead of HR value.

6.3 SPO2 Alarm Message

Alarm occurs when SPO2 exceeds the alarm limit.
Alarm Situation Visual prompts Audio Sound
SPO2 violates adjusted alarm ●SPO2 value blinks.
SPO2 Alarm Activated
limits ●Alarm indicator flashes.
SPO2 Pulse beat is not detected in last ●Message "SPO2
Activated
ASYSTOLE 10 seconds. ASYSTOLE" is displayed
SPO2 message includes:

message Cause solution explanation
Alarm level 3,The message is
Make sure that the probe is
SPO2 probe is disconnected blinking. Pressing ALARM
SPO2 NO PROBE correctly connected to the
from the monitor. SILENCE, alarm will be disabled
monitor.
and ignore this fault.
SPO2 PROBE blinking. Pressing ALARM
The SPO2 probe is damaged Change the SPO2 probe.
DEFECT SILENCE, alarm will be disabled
SPO2 probe may be Make sure that SPO2 probe is blinking. Pressing ALARM
SPO2 PROBE OFF
detached from the patient. properly attached to the patient SILENCE, alarm will be disabled
Make sure that SPO2 probe is blinking. Alarm is activated when
SPO2 CHECK SPO2 probe is not properly
properly connected to the SPO2 ALARM is "ON". Pressing
PROBE positioned to the patient
patient (refer to page 6-2). ALARM SILENCE, alarm is
suspended for at least 120s.
This may be caused by Make sure that SPO2 probe is blinking. Alarm is activated when
SPO2 HIGH
entering environmental light properly connected to the SPO2 ALARM is "ON". Pressing
AMBIENT LIGHT
into the probe patient (refer to page 6-2). ALARM SILENCE, alarm is
suspended for at least 120s.
SPO2 is not calculable due Move the sensor to another
SPO2 SEARCH to some reasons such as long place, provoke blood recycle,
time motions. and calm the patient.
SPO2 SIGNAL The SPO2 signal amplitude
Change the place of the probe.
WEAK is too weak or undetectable.
Power off and then on the Alarm level 2,The message is
system .If this message is blinking. Pressing ALARM
SPO2 DEFECT SPO2 module failure displayed again, the user SILENCE, alarm will be disabled
should contact local After Sale and ignore this fault.
Service.
After checking the mentioned solution if above mentioned messages are displayed again, the
SPO2 probe may be damaged and you should contact with local After Sales Services.

6.4 SPO2 PROBE CLEANING

To clean the sensor, first remove it from the patient and disconnect it from the monitor. You may
then clean the probe by wiping it with a 70% isopropyl alcohol pad. Allow the probe to dry prior
to placement on a patient.
Warning
Do not sterilize the patient cable and probes by autoclave, irradiation, steam or ethylene
oxide.
Warning
To prevent damage, do not immerse the probe in any liquid solution.
Warning
Do not use any probe or cable that may be damaged or deteriorated.

7.4 NIBP Monitoring

7.1 GENERAL
NIBP (Non-invasive Blood Pressure) processing by the monitor uses the oscillometric measuring
technique. A motorized pump inflates the cuff initially, until the pressure effectively occludes
flow of blood in the extremity. Then, under monitor control, the pressure in the cuff is gradually
reduced, while a pressure transducer detects air pressure and transmits a signal to the NIBP
circuit.
As the cuff pressure is reduced, blood flows in the previously occluded artery and changes the
measured pressure values sensed by the transducer. The point at which oscillation increases
sharply is defined as systolic pressure. As the cuff continues to deflate, oscillation amplitude
increases to a maximum, and then decreases. The peak oscillation amplitude is defined as the
mean arterial pressure. The point at which the system detects a loss of oscillation is defined as
the diastolic pressure.
■ Blood pressure measurement according to this method is equivalent to the cuff-ethoscope

method.
■ According to the European standard EN 1060-1: Specification for Non-invasive
sphygmomanometers Part 1, General requirements.
■ It is applicable for adults and neonates.
■ There are three modes of measurement available: manual ,automatic and stat.
Each mode displays the systolic, diastolic and mean blood pressure.
□ In the MANUAL mode, only one measurement is performed.
□ In the AUTO mode, the measurement is cycled. You can set the interval time to
1,2,3,5,10,15,20,30,45,60,90 minutes and 2, 4,6,8,12,16,20,24 hours
□ In STAT mode, measurement is performed up to ten times in 5 minutes
and with 30s interval between measurements. If an error occurs, NIBP
measurement is suspended.
Warning
1. You must not perform NIBP measurements on patients under any condition which the
skin is damaged or expected to be damaged.
2. Ensure that the correct setting is selected when performing measurements on children. It
may be dangerous for the children to use an over pressure level.
NIBP Measuring
Warning
■ Before starting a measurement, verify that you have selected a setting appropriate
for your patient (adult or neonate.)
■ Do not apply the cuff to a limb that has an intravenous infusion or catheter in place.
This could cause tissue damage around the catheter when infusion is slowed or
blocked during cuff inflation.

Warning
Use only recommended manufacturer Blood Pressure Cuffs and Hose. Using other cuffs or
hoses may result in inaccuracies.
Warning
Blood pressure measurement can be affected by the position of the cuff and patient's
physiological condition.
Warning
According to general requirement for safety, Luer lock connectors are not used .Don't use
NIBP cuff with Luer lock connector because if Luer lock connector is used, there is a
possibility that they might be inadvertently connected to intravascular fluid systems,
allowing air to be pumped in to blood vessel.
Warning
Make sure that the air conduit connecting the blood pressure cuff and the monitor is
neither blocked nor tangled.
Warning
In this module the maximum cuff inflation pressure is 288 mmHg in adult mode and it is
146 mmHg for neonate mode. Furthermore independent maximum pressure control
preservative is forecasted inside the system.
Also maximum time of being under pressure for cuff has been limited to 2 minutes in each
measurement, however it is necessary that operators pay attention that long-time and
continuous measurements can redound to muscular and neurotic harms or skinny injuries.
1. Plug in the air hose and switch on the system.

2. Apply the blood pressure cuff to the patient's arm or leg following the instructions below
(Figure 7-1).
■ Ensure that the cuff is completely deflated.
■ Apply the appropriate size cuff to the patient. Ensure that the cuff is not wrapped too
tightly around the limb. Excessive tightness may cause discoloration and eventual
ischemia .
Figure 7-1 Applying Cuff
NOTE:

The width of the cuff should be either 40% of the limb circumference (50% for
neonates) or 2/3 of the upper arm length. The inflatable part of the cuff should be
long enough to encircle 50-80% of the limb. The wrong size of cuff can cause
erroneous measurement. If the cuff size is in question, then use a larger cuff. (Refer
to chapter 20 for more detail about size of cuff.)
3. Connect the cuff to the air hose. The limb chosen for taking the measurement should be
placed at the same level as the patient's heart.
4. Check whether the patient mode is appropriately selected. To change the patient mode,
choose SETUP from the HOME WINDOW, the HOME/SETUP WINDOW menu will
pop up. Pick ADULT/NEONATE to make necessary changes.
5. Select a measurement mode in the NIBP WINDOW menu. Refer to the following
instructions," Operation Hints ", for details.
6. Press the START/STOP button on the front panel to start a NIBP measurement.
Operation Hints
1. To start a MANUAL measuring:

Press the START/STOP button on the front panel
2. To stop a MANUAL measuring

Repress the START/STOP button on the front panel
3. To start AUTO measuring:

Select NIBP WINDOW menu and pick AUTO for measuring interval setting, then Press
START/STOP button on the front panel.
Warning
Prolonged non-invasive blood pressure measurements in Auto mode may be associated
with ischemia and neuropathy in the limb wearing the cuff. When monitoring a patient,
examine the limb frequently for normal color, warmth and sensitivity. If any abnormality
is observed, stop the blood pressure measurements.
4. To start a MANUAL measuring during the AUTO mode:

Press START/STOP button on the front panel.
5. To stop AUTO measuring:

Select the NIBP menu and set AUTO /MANUAL to MANUAL mode.
NOTE:
If you are in doubt about the accuracy of any measurement(s), check the patient's
vital signs by an alternative method before checking the functionality of the
monitor.
Warning

If liquid is inadvertently splashed on the equipment or its accessories, turn off the system
and dry it with soft cloth and then use it again.
Measurement Limitations
In different patient conditions, the oscillometric measurement has certain limitations. The
measurement is in search of regular arterial pressure pulse. In those circumstances, when the
patient's condition makes it difficult to detect, the measurement becomes unreliable and
measuring time increases. The user should be aware that the following conditions could interfere
the measurement and make the measurement unreliable or longer. In some cases, the patient's
condition will make a measurement impossible.
● Patient Movement
Measurements will be unreliable or may not be possible if the patient is moving, shivering or
having convulsions. These motions may interfere the detection of the arterial pressure pulses. In
addition, the measurement time will be prolonged.
● Cardiac Arrhythmia's
Measurements will be unreliable and may not be possible if the patient's cardiac arrhythmia
causes an irregular heart beat. Thus the measuring time will be prolonged.
● Heart-lung Machine
Measurements will not be possible if the patient is connected to a heart-lung machine.
● Pressure Changes
Measurements will be unreliable and may not be possible if the patient's blood pressure changes
rapidly over the period of time during which the arterial pressure pulses are being analyzed to
obtain the measurement.
● Severe Shock
If the patient is in severe shock or hypothermia, measurements will be unreliable because of
reduced pulsation of the arteries.
● Heart Rate limits
Measurements can not perform at a heart rate of less than 40 bpm and greater than 240 bpm.
7.2 NIBP WINDOW

NIBP measurement result is displayed as follows:

NIBP WINDOW menu
Figure 7-2 NIBP WINDOW

■ NIBP UNIT
Pick this item to adjust measurement unit. (Options: mmHg or KPa)
■ ALARM LEVEL
■ NIBP ALARM
Pick "ON" to enable NIBP alarm functions such as parameters blinking, audio alarm and
light indicator. Pick "OFF" to disable the alarm functions and there will be a " "symbol
■ NBP SYS LIMIT

SYS alarm is activated when the systolic pressure exceeds adjusted ALARM HIGH value
or falls below adjusted ALARM LOW value. (min:30 and max:240)
■ NBP DIA LIMIT

DIA alarm is activated when the diastolic pressure exceeds adjusted ALARM HIGH
value or falls below adjusted ALARM LOW value.(min:20 and max:180)
■ NBP MAP LIMIT

MAP alarm is activated when the mean arterial pressure exceeds adjusted ALARM
HIGH value or falls below adjusted ALARM LOW value.(min:25 and max:200)
■ AUTO/MANUAL/STAT
There are three modes of measurement available: MANUAL, AUTO and STAT. In the
MANUAL mode, only one measurement is performed. In the AUTO mode, measurement
is repeated over a specified period of time ; available intervals are 1,2,3,5,10,15,20,30
,45,60,90 minutes and 2, 4,6,8,12,16,20,24 hours. In STAT mode, measurement is
performed up to ten times in 5 minutes and with 30s interval between measurements. If
an error occurs, NIBP measurement is suspended.
<MODULE START>
To start measurement
<MODULE STOP>
To stop measurement

<MODULE RESET>
To set maximum inflation pressure of cuff to 150mmHg for adult and 70mmHg for
neonate.
■ NIBP LIST
Patient monitor can review the latest 100 NIBP measurement data.
Pick "NIBP LIST" in the NIBP WINDOW to invoke the result and time of the latest
NIBP measurements, as shown in Figure 7-3
Figure 7-3 NIBP/NIBP LIST WINDOW
By pressing the first left item you can select a line of NIBP recorded data and you will be able to
delete a line of data in NIBP LIST by pressing the "DELETE".(second left item)
■ MODULE CHECK
Available options are "NIBP MANOMETER","NIBP LEAKAGE","MODULE SELF
TEST","MODULE STOP".
NIBP MANOMETER
Wrap the cuff around a rigid cylinder. Connect a calibrated reference manometer and a ball
pump by means of a T-piece connector and hoses to the monitor. Set the monitor in" NIBP
MANOMETER" mode. Inflate the pneumatic system to 0, 50 and 200 mmHg by ball pump
separately. The difference between the indicated pressure of the reference manometer and the
indicated pressure of the monitor should not exceed ±3 mmHg.
NIBP LEAKAGE
Wrap the cuff around a cylinder of an appropriate size, and the circumference of the applied cuff
does not exceed that of the cylinder more than 7%.Set the monitor in "NIBP LEAKAGE" mode.
The monitor inflates the cuff up to 170mmHg and keeps it constant for 15 sec .If air leakage
result is satisfactory, "NIBP LEAK OK" message is displayed; otherwise you will receive
"PNUMATIC LEAK" message.

NOTE:
These test must only done by personnel trained and authorized by manufacturer.
7.3 NIBP Alarm Message

Alarm occurs when the pressure (SYS. DIA or MAP) exceeds the alarm limit

SYS violates adjusted alarm
● SYS value blinks
SYS ALARM limits or violates lower than Activated
●alarm indicator flashes.
50mmHg
DIA violates adjusted alarm ● DIA value blinks
DIA ALARM Activated
limits ●alarm indicator flashes.
MAP violates adjusted alarm
● MAP value blinks
MAP ALARM limits or violates lower than Activated
●alarm indicator flashes.
30mmHg

NIBP messages include:
Message Cause
SELF-TEST FAILED NIBP hard ware module failure
LOOSE CUFF Cuff is completely unwrapped, no cuff attached
Use adult cuff instead of neonate cuff or occlusion happened in air
MODE ERROR
way
AIR LEAK Air leak in cuff, hose or connector
Unstable pressure value(e.g. kinked hoses)because valve cannot
AIR PRESSURE ERROR
open normally
Very weak patient signal due to a loosely wrapped cuff or extremely
SIGNAL WEAK
weak pulse from patient.
Measuring pressure is more than upper limit (255mmHg)for adult or
RANGE EXCEED
(135mmHg) for neonate
EXCESSIVE MOTION Arm movement, noisy signal or irregular pulse(e.g. arrhythmia)
OVER PRESSURE Measuring pressure exceeded safe software limit, 290 mmHg for
SENSED adult and 145mmHg for neonate.
Large motion artifact that saturates the amplifier's amplitude
SIGNAL SATURATED
handling capability
PNEUMATIC LEAK Leakage during leak test
TIME OUT Measuring time exceeds 120 seconds (adult) or 90 seconds (neonate)
Error occurs in pump, A/D sampling, pressure transducer or
SYSTEM FAILURE
software.
NIBP DEFECT NIBP module failure
The Charge of battery is low so NIBP measurement is not possible

LOW BATTERY
(while the monitor is working with battery).
NIBP NO MODULE No NIBP module is installed.
STOP PRESSED NIBP stop key has been pressed during measurement.
NIBP STOP Measurement is stopped by NIBP module because of special reason.
NIBP LEAKAGE O.K Successful leakage test.
All alarm level for these messages (except the last third message) is set in NIBP WINDOW.
Pressing ALARM SILENCE, alarm will be disable and ignore this fault.

7.4 NIBP CUFF CLEANING

Warning
Do not press the cuff and tubing with a hot iron.
■ Cleaning
Durable one-piece cuffs may be safely cleaned with a damp cloth (70% alcohol or
0.5% bleach solution may be used) or washed in water (140ºF, 60ºC maximum)
with soap or detergent.
■ Sterilization
Do not use steam or heat to sterilize the cuff. Gas sterilization may be used if
necessary.
■ Disinfection
Glutaraldehyde type liquid disinfectants may be used on durable cuffs. Prolonged
used of these disinfectants at full strength may cause discoloration of the white
cuff marking.

CHAPTER 8 TEMP Monitoring

8.1 GENERAL
Measurement of patient temperature is accomplished by processing the signal from a probe
containing temperature dependent resistor called thermistor .Value of this resistor is measured by
the monitor continuously and displayed on screen. Patient monitor has two different kind of
temperature probe, a probe for esophageal /rectal temperature measurement and other for skin
temperature measurement.
Specification:
Measuring and Alarm Range 0~50 ºC
Accuracy ± 0.2 º C
Delay time For rectal/esophageal probe 50sec
For skin probe 20sec
Two TEMP probes can be used together to obtain 2 temperature data and compare them to
determine the temperature difference.
TEMP monitoring setup:

■ Plug TEMP probe directly into the monitor.
■ Attach the TEMP probe(s) properly to the patient.
■ Switch on the system.
Inspection and recalibration

Visually inspect the probe for cracks, holes, crazing etc, prior to each use. If any such
degradation in the cable jacket is discovered, discard probe according to your hospital's
procedure for medical waste. When using temperature probe, the user must determine that a
probe style is suitable and sufficiently flexible for esophageal or rectal use.
Probe cannot be "recalibrated" per se, but should be inspected monthly by the hospital
Biomedical Equipment group to ensure they are working properly. Probes can be tested by
plugging into a patient monitor and looking for an electrical open or short–circuit, Intermittent
reading or extremely inaccurate readings which would indicate probe wire damage. The sensor
stability is well-documented; Probe accuracy should not drift out of tolerance over the normal
life of probe.
NOTE:
Please be note that the metal side should be used for making measurements.
WARNING
Handle the TEMP probes with due care. The probe and cable should be rolled up to a loose
loop when not in use. Over straining will result in mechanical damage of the probes.
WARNING
The temperature probes carry a one-year warranty on workmanship, components and
accuracy tolerances. Probe life with normal use should exceed one year.

WARNING
Using ESU with temperature measurement simultaneously, may cause patient burn. If
possible, remove the probe from patient contact before activating the surgical unit or other
RF source. If probe must be used simultaneously with electrosurgical apparatus, hazards
can be reduced by selecting a temperature monitoring point which is remote from the
expected RF current path to the ground return pad.
WARNING
The calibration of the temperature measurement is necessary every two years (or as
frequently as dictated by your Hospital Procedures Policy). When you need to calibrate the
temperature measurement, contact the local After Sale Service.
8.2 TEMP WINDOW

The TEMP WINDOW menu is as follows:
Figure 8-1 TEMP WINDOW

■ UNIT
Pick this item to set measurement unit. (options: ºC or ºF)
■ ALARM LEVEL
■ TEMP ALARM
Pick "ON" to enable TEMP alarm functions such as parameters blinking, audio alarm, and
light indicator.Pick "OFF" to disable the alarm functions and there will be a " " symbol
■ T1 LIMIT
T1 alarm is activated when the channel-1 temperature exceeds adjusted ALARM HIGH
■ T2 LIMIT
T2 alarm is activated when the channel-2 temperature exceeds adjusted ALARM HIGH
■ DT LIMIT
DT alarm is activated when the different between channel-1 and channel-2 exceeds adjusted
ALARM HIGH value or falls below adjusted ALARM LOW value.(min:0 and max:50)

T1 is Channel-1 of temperature.
T2 is Channel-2 of temperature
DT is the temperature difference between the above two.
8.3 TEMP ALARM MESSAGE

Alarm occurs when:
The Alarm function is "ON" and temperature exceeds adjusted alarm limits.
8.4 TEMP SENSOR CLEANING AND STORAGE

To clean the temp sensor, first remove it from the patient and disconnect it from the monitor.
NOTE:
Reusable temperature probes are sold non- sterile.
■ Cleaning
Probe should be cleaned of bioburden prior to disinfection or sterilization to improve the
effectiveness (as recommended in ANSI/AAMI ST35: Good Hospital Practice: Handling and
Biological Decontamination of Reusable Medical Device,1991)
When wiping clean, hold the probe in one hand at the sensing tip and wipe the probe and lead
wire toward the plug. Excessive pressure could stretch the cable jacket and break the internal
wires, destroying the probe .Continued flexing of lead wires in use and cleaning can also break
the internal wire .
Avoid contact with strong, aromatic, chlorinate, ketone, ether or ester solvents. Prolonged
immersion in alcohols or mild organic solvents, detergent solutions or highly alkaline solutions
will cause the vinyl to lose flexibility. The probe plugs should not be immersed.
■ Sterilization
Ethylene oxide is the preferred sterilization method. After sterilization, probes must be safely
and thoroughly ventilated before handling or use. Using a generic EtO sterilizing procedure, YSI
recommends an aeration time of 12 hours minimum to dissipate residual EtO in probe below
250ppm.
■ Disinfection
Probes may be disinfected by washing with 70% isopropanol, activated dialdehyde (Cidex) or
sodium hypochlorite (bleach diluted 1:10 minimum in water.) After washing probes should be
rinsed thoroughly with water. Brief immersion of the probe in detergent solutions is not harmful.
Manufacturer does not make any claim as to the efficacy of these chemicals for infection control.
Please consult your hospital's Infection Control Officer for the applicable disinfection policies.
Warning
Never boil the standard YSI400 or YSI700 series temperature probe.
Storage and Handling

When not in use, probes and leads should be loosely coiled and stored at room temperature .Do
not wrap probes around equipment cases to avoid damaging internal wires.

CHAPTER 9 IBP Monitoring

9.1 GENERAL
Specification:
Displaying and measuring ranges (for all labels) -50~300(mmHg)
Alarm ranges
IBP -50~300(mmHg)
ART -50~300(mmHg)
LVP -50~300(mmHg)
PAP -50~120(mmHg)
RVP -50~100(mmHg)
CVP -50~100(mmHg)
LAP -50~100(mmHg)
RAP -50~100(mmHg)
Resolution 1 (mmHg)
Accuracy 2 % or 2mmHg each one is greater
Patient Monitor measures direct blood pressure (SYS, DIA and MEAN) of the selected blood
vessel through two channels, and displays two BP waveforms
Warning
The operator should avoid contacting with to the conductive parts of the system when
being applied.
Warning
When using ESU (Electrosurgery equipment), the transducer and the cables should not be
contacted with the conductive part of ESU to protect patient against burns.
Warning
Disposable IBP transducer or domes should not be reused.
Warning
Be careful that all packages are safe before using domes, and make sure that they are
sterilized and pay attention to the expiry date.
Warning
Use only the pressure transducer listed in the Chapter 20.5 IBP Accessories.
The specified transducer are designed to have the special ability to protect patient against the
electrical shock (especially for the leak current allowed), and it is protected against the effects of
a discharge of a cardiac defibrillator. It can be used in the surgical operation. During
defibrillation, the IBP waveform may be distorted temporarily.
Warning
Verify transducer cables fault detection prior to the start of monitoring phase. Unplug the
transducer of the channel 1 from the socket, the screen will display the error message
"IBP1 NO SENSOR" and the audible alarm is activated with level 3. Next channel is the
same.

Preparatory steps for IBP measurement (Figure 8-2):

1 Plug the pressure cable into corresponding socket.
2 Prepare the pressure tube and transducer by flushing through the tubing system with
normal saline solution. Ensure that the tubing system is free of air bubbles.
3 Connect the patient catheter to the pressure line, making sure that there is no air present
in the catheter or pressure line.
Warning
If there are air bubbles in the pressure line or the transducer, you should flush the solution
to the system.
4 Place the transducer at the same level with the patient's heart.
5 Check if you have selected the correct label name. See the next chapter for details.
6 Zero the transducer. See the next section for details.
7 Calibrate the IBP monitor with a reference pressure if you have changed the transducer or
if you are not sure about the accuracy.
See the next section for details.
Figure 9-1 IBP Monitoring
9.2 IBP WINDOW

The IBP WINDOW menu is as follows:
Figure 9-2 IBP WINDOW
■ IBP1/IBP2 UNIT
Pick this item to adjust measurement unit. (Options: mmHg, Kpa, cmH2O)

■ IBP1/IBP2 LABLE
Suitable label should be selected, regarding the place of measurement. The available
pressure labels are:
Label Definition
ART Arterial Blood Pressure
LVP Left Ventricle Pressure
PAP Pulmonary Artery Pressure
RVP Right Ventricle Pressure
CVP Central Venous Pressure
LAP Left Atrium Pressure
RAP Right Atrium Pressure
Warning
IBP algorithm will vary according to the selected label. Therefore in the case of improper
label selecting, the accuracy of the measurement may be decreased.
■ IBP SWEEP
Available options for IBP SWEEP are 3,6,12.5 and 25mm/s.
■ IBP GRID
Select "ON" to divide each IBP signal to 5 parts with white dot lines.
■ IBP FILTER
In order to have a more clear and detailed waveform, 3 filter types can be selected:
Available options are 22Hz, 16Hz, and 8Hz.
22Hz : Recommended in normal use and the most clinical situation. It has the most
measuring accuracy among the called filters.
16Hz : When the signal is a bit noisy.
8Hz : This mode is recommended to reduce noise and interface resulted from ESU and
also when the system has a high noise level or doesn’t have equipotential earth. While
using this filter the measuring accuracy might be decreased.
■ ALARM
Pick "IBP ALARM" in IBP WINDOW to call up the following menu:
Figure 9-3 IBP/ALARM WINDOW

■ IBP1/IBP2 ALARM
Indicator.Pick "OFF" to disable the alarm functions and there will be a " " symbol instead
of alarm limits in Parameters Area.

■ IBP1/IBP2 ALARM LEVEL

■ SYS ALM
SYS alarm is activated when the systolic pressure exceeds adjusted ALARM HIGH value or
falls below adjusted ALARM LOW value.
■ DIA ALM
DIA alarm is activated when the diastolic pressure exceeds adjusted ALARM HIGH value or
■ MEAN ALM
MEAN alarm is activated when the mean pressure exceeds adjusted ALARM HIGH
value or falls below adjusted ALARM LOW value.
NOTE:
The alarm High/Low limits for SYS, DIA and MEAN of ART, LVP, PAP, RVP,
CVP, LAP, RAP are listed as follow. Note that the CVP, LAP and RAP only have
MEAN pressure , therefore the alarm limit are only for MEAN.
The alarm occurs when the value exceeds the set limits.
Min Alarm High Min Alarm High Step
Lable
(mmHg) (mmHg) (mmHg)
IBP -50 300 5
ART -50 300 5
LVP -50 300 5
PAP -50 120 1
RVP -50 100 1
CVP -50 100 1
LAP -50 100 1
RAP -50 100 1
■ IBP SCALE
Pick "IBP SCALE" in IBP WINDOW to call up the following menu:
Figure 9-4 IBP/SCALE WINDOW

The waveform and corresponding scale appears in the IBP waveform area with 3 dotted lines
representing HIGH limit scale, SIGN cursor, and LOW limit scale from the top to the bottom
values of the three scales can be manually set or automatically by Auto scale. You can change
the scales for IBP, ART and LVP labels by step of 10 and for PAP, RVP, CVP, LAP and RAP
labels by step of 5.
■ AUTO SCALE
Pick <AUTO SCALE>in IBP WINDOW to adjust the scale automatically .Scales are adjusted in
a way that signal occupied approximately 80% of IBP waveform area.

■ IBP ZERO
Pick < ZERO> in IBP WINDOW to call up the following menu:
Figure 9-5 IBP/ZERO WINDOW
NOTE:
Since transducers need to be warmed to achieve the best accuracy it is
recommended to zero the system at least 15 minutes after connecting the IBP
transducer to the system.
NOTE:
Zero procedure should be performed before starting the monitoring and at least
once a day after each disconnection and connection of the cable.
Zero the transducer:

1-The transducer should be placed at mid-heart level.
2-Turn off patient stopcock.
3-The transducer must be vented to atmospheric pressure.
4-Select < IBP1/IBP2 ZERO > to start zeroing procedure for each channel.
The message "PLEASE WAIT" will display during the procedure. When the procedure finished
successfully the message "IBP1/IBP2 OK" appears.
The last zeroing time will be saved and displayed in its corresponding place.
5-turn stopcock to patient on and the other stopcock to atmospheric pressure off.
The following messages may prompt up in ZERO WINDOW:
■ "IBP1/IBP2 NO SENSOR, UNABLE TO ZERO"

Make sure that the transducer is connected or not, then start zeroing.
■ "IBP1/IBP2 OVERANGE, FAILED ZEROING"

Make sure that the stopcock is vented to atmosphere. If the problem persists, contact
after sale service.
■ "IBP1/IBP2 UNSTABLE PRESSURE, UNABLE TO ZERO"

Make sure that the transducer is not attached to the patient and that the stopcock is vented
to atmosphere or perhaps the tubing system is hited accidentally .If the problem persists,
contact after sales service.

■ IBP CALIB
Pick < CALIB> in IBP WINDOW to call up the following menu:
Figure 9-6 IBP/CALIB WINDOW
Figure 9-7 IBP CALIBRATION
■ Mercury calibration should be performed by the biomedical engineering department either

whenever a new transducer is used, or as frequently as dictated by your Hospital Procedures
policy.
■ The purpose of the calibration is to ensure that the system gives you accurate measurements.
■ Before starting a mercury calibration, a zero procedure must be performed.
Warning
You must never perform this procedure while patient is being monitored.

1. Attach the tubing to the sphygmomanometer.

2. Ensure that connection that would lead to patient is off.
3. Connect the 3-way connector to the 3-way stopcock that is not connected to the patient
catheter.
4. Open the port of the 3-way stopcock to the sphygmomanometer.
5. Raise the sphygmomanometer to set value that you adjusted in CALIB WINDOW menu.
6. Choose a CAL-> in the CALIB WINDOW menu.
7. Press the rotary knob to start the calibration.
The message "PLEASE WAIT" will display during the procedure. "IBP1/IBP2 CALIBRATION
OK" indicates that the calibration procedure is completed successfully.The last calibration time
will be saved and displayed in its corresponding place.
The following messages may prompt up in CALIB WINDOW:

■ "IBP1/IBP2 NO SENSOR, UNABLE TO CALIBRATE"
Make sure that the transducer is connected or not, then start calibration procedure.
■ "IBP1/IBP2 OVERANGE, UNABLE TO CALIBRATE"

Verify that adjusted pressure in menu and sphygmomanometer pressure are equal.If the
problem persists, contact after sale service.
■ "IBP1/IBP2 UNSTABLE PRESSURE, UNABLE TO CALIBRATE"

Make sure that the transducer is not attached to the patient or perhaps the tubing system is
hited accidentally .If the problem persists, contact after sales service.
8. Remove the sphygmomanometer tubing and extra connector.

9-3 IBP Alarm Message

Alarm occurs when the pressure (SYS, DIA or MEAN) exceeds the alarm limit

SYS violates adjusted alarm ● SYS value blinks
SYS ALARM Activated
limits ●alarm indicator flashes.
DIA violates adjusted alarm ● DIA value blinks
DIA ALARM Activated
limits. ●alarm indicator flashes.
MEAN violates adjusted alarm ● MEAN value blinks
MEAN ALARM Activated
limits. ●alarm indicator flashes.
IBP message include:
Message cause solution explanation

Alarm level 3, The message is
IBP1/IBP2 NO Channel 1 or 2 transducer is not blinking. Pressing ALARM
Check the transducer connection.
SENSOR connected. SILENCE, alarm will be
disabled and ignore this fault.
IBP1/IBP2 ADJUST IBP1 or IBP2 signal is in out of display Press <AUTO SCALE> in IBP
SCALE range for about 5 seconds. WINDOW menu.
This condition occurs when the
maximum and minimum values of a
pulsatile pressure signal (Just for IBP,
ART, PAP, RVP and LVP labels) ●Check patient and do necessary
differ by less than 3mmHg.In this case, treatment
only Mean pressure is displayed in this ●Turn on the stopcock to patient
state. and turn it off to the atmospheric
IBP1/IBP2 STATIC blinking. Pressing ALARM
This message can be caused by the pressure.
PRESSURE SILENCE, alarm will be
following reason: ●Follow hospital procedure for
● A physiological condition e.g. dislodging catheter.
asystole ●Follow hospital procedures for
● Transducer turned off to the patient. clotted catheters.
● A catheter tip lodged against a vessel
wall.
● A clot on the catheter tip.
●Check all IBP measurement
IBP signal can’t be processed by the
setup is suitable or not.
IBP1/IBP2 SEARCH software because the signal is weak or
●Check patient and treat if
less pulsatile.
necessary.

9.4 IBP TRANSDUCER CLEANING

Clean all blood and other outer materials from the external surface of the transducer and cable
using a slightly damp cloth and a mild detergent solution. Do not immerse. do not use alcohol or
solvents on the clamps. Rinse thoroughly.
NOTE:
The disposable transducers or domes must not be re-sterilized or re-used.
NOTE:
For protecting environment, the disposable transducers or domes must be recycled
or disposed properly.
Warning
Does not autoclave or ETO sterilize the transducer?

10 GAS Monitoring (mainstream)

10.1 GENERAL
Patient Monitor provides mainstream method for Gas measurement.
The mainstream multi-gas probe is intended to be connected to a patient breathing circuit for
monitoring of inspired/expired gases of adults, pediatrics and infant patient during anesthesia,
recovery and respiratory care. It may be used in the operating suite, intensive care unit (ICU),
patient room and emergency medicine settings.
The sensor head is available in various configurations for ICU and OR applications.
Concentrations of carbon dioxide (CO2), nitrous oxide(N2O), halothane(HAL), enflurane(ENF),
isoflurane(ISO), sevoflurane(SEV) and desflurane(DES) in different combinations are
determined together with derived parameters such as respiratory rate, waveform and
inspired/expired concentrations of all gases.
It is available in various parameter configurations as follow:

CO2 only sensor: CO2
ICU sensor: CO2, O2
OR sensor: CO2, N2O, O2, two anaesthesia agent (HAL, ISO, ENF, SEV,
DES), MAC
OR+ sensor: CO2, N2O, O2, two anaesthesia agent (HAL, ISO, ENF, SEV, DES)
, automatic gas detection, MAC
AX sensor: CO2, N2O, two anaesthesia agent (HAL, ISO, ENF, SEV, DES),
MAC
AX+ sensor: CO2, N2O, two anaesthesia agent
(HAL, ISO, ENF, SEV, DES), automatic gas detection, MAC
Measuring principle
The IRMA sensor head snaps in place on the top of the airway adapter that includes the optical
components for measuring all gases. The airway adapter is inserted between the endotracheal
tube and the Y-piece of the breathing circuit. The respiratory gas measurements are obtained by
continuously measuring the infrared gas absorption through the XTP windows in the gas flow
through the adapter.
To measure the concentrations and identify the gases, absorption of up to nine different
wavelengths of infrared light is measured.
The measurement of CO2, N2O and anaesthetic agents in the breathing gas mixture is based on
the fact that the different gas components absorb infrared light at specific wavelengths. A
microprocessor continuously calculates the CO2, N2O and anaesthetic agent concentrations from
the infrared light absorption measurements. Using matrix calculations to identify which
anaesthetic agents are present in the gas mixture.
The oxygen measurements are obtained through an oxygen port at the top of the airway adapter.
Oxygen does not absorb infrared light to the same extent as other breathing gases and is
therefore measured using an ultra rapid response time oxygen sensor.
(For more detail refer to APPENDIX IV)
The measured parameters are EtCo2, EtN2O, EtO2, EtAA (End Tidal CO2/N2O/O2,Anesthesia
Agent), FiCo2, FiN2O, FiO2, FiAA (Fraction Inspiratory CO2/N2O/O2/Anesthesia Agent),
AWRR (Air Way Respiratory Rate) and MAC.

Warning
The IRMA probe is intended for use only as an adjunct in patient assessment .It must be
MAC (Minimum alveolar concentration)

Minimum alveolar concentration or MAC is a concept used to compare the strengths of
anesthetic vapors; in simple terms, it is defined as the concentration of the vapor in the lungs that
is needed to prevent movement (motor response) in 50% of subjects in response to surgical
(pain) stimulus. Thus, it is actually a median value.
The MAC value may be calculated and displayed by using end-tidal (ET) gas concentrations
according to the following formula:
MAC = %ET(AA1)/X(AA1) + %ET(AA2)/X(AA2) + %ET(N2O)/100

X(AA): HAL=0.75%, ENF=1.7%, ISO=1.15%, SEV=2.05%, DES=6.0%
NOTE:
The patient age as well as other individual factors is not taken into account in the above
described formula. ET gas concentrations for secondary agent (AA2) is only available for IRMA
AX+/OR+ probes
Oxygen sensor:
IRMA mainstream multi-gas probe consists of an O2 sensor cell as an option.
IRMA oxygen sensor is specially designed to provide an ultra fast response time, thus allowing a
breath-by-breath analysis of the oxygen waveform at a proximal location (i.e. between the
patient's endotracheal tube and the Y-piece of the breathing circuit). The vast majority of oxygen
sensors available on the market are normally too slow for a breath-to-breath gas analysis.
For anaesthesia machines and ventilators already equipped with oxygen measuring devices, the
IRMA sensor is available with an O2 sensor dummy instead of the normal oxygen sensor. Figure
11-1 shows both the normal O2 sensor and the oxygen sensor dummy.
The ultra fast response time oxygen sensor is normally integrated in the IRMA sensor head
allowing proximal measurement of INSP/EXP oxygen concentrations.
Figure10-1 Oxygen sensor dummy and oxygen sensor.

The oxygen sensor dummy can be replaced at any time by a normal sensor to allow oxygen
measurements with the IRMA sensor.
To replace the oxygen sensor, remove the depleted oxygen sensor by using a screwdriver or
other suitable tool and turn in a counterclockwise direction. Remove the depleted sensor and
carefully screw the new oxygen sensor into position.

Warning
Oxygen sensor for replacement should be stored in a cold environment (+2°C~+8°C) and
should be taken into operation before the expired date printed on the package.
Replace the oxygen sensor every four months, when the system warns to change the sensor with
"REPLACE O2 SENSOR" message or when the oxygen readings are questionable.
Warning
Use only the recommended oxygen sensor for O2 monitoring .Other oxygen sensors may
cause improper performance. (Refer to chapter 20 for detail)
Warning
Depleted oxygen sensors shall be disposed of in accordance with local regulations for
biologically hazardous materials.
Warning
Do not leave depleted oxygen sensors mounted in the IRMA probe, even if the probe is not
in use.
Warning
Do not try to open the oxygen sensor assembly. The oxygen sensor is a disposable product
and contains a caustic electrolyte and lead.

Airway adapter:
The airway adapter is designed as a disposable for both adult/pediatric and infant applications.
The adult/pediatric adapter is available with or without an oxygen port.
The airway adapter with an oxygen port is equipped with a hydrophobic bacteria filter to protect
the oxygen sensor from contamination. For anaesthesia machines and ventilators already
equipped with oxygen measuring device, the airway adapter is available without an oxygen port.
Figure 10-2 IRMA airway adapters:

Adult/Pediatric with and without an oxygen port and infant adapter.
Warning
Disposable airway adapters shall not be reused. Used disposable airway adapters shall be
disposed of in accordance with local regulations for contaminated and biologically
hazardous fluids.
Warning
Do not use the IRMA adapter if adapter or its package is damaged and return it to the
vendor.
Warning
Use only the recommended IRMA airway adapters for monitoring .Other airway adapters
may cause improper performance. (Refer to chapter 20 for detail)
Warning
Do not use the adult/pediatric airway adapter with infants as the adapter adds 6ml dead
space to the patient circuit.
Warning
Do not use the infant airway adapter with adults as this may cause excessive flow
resistance.
The infant airway adapter has specially designed connectors for minimizing the dead space and
can be used even for very small patients. The infant adapter is available without an oxygen port
only.

Preparatory steps for gas measurement (Figure 10-3):

1. Plug the IRMA connector into the bedside monitor side panel.
2. Snap the IRMA sensor head on top of the IRMA airway adapter. It will click into place when
properly seated.
Figure 10-3 a Preparatory Step2
3. A green indicator indicates that the IRMA sensor is ready for use.
Figure 10-3 b. Preparatory Step3
4. Connect IRMA airway adapter 15 mm male connector to the breathing circuit Y-piece.
Figure 10-3 c. Preparatory Step 4

5. Connect the IRMA airway adapter 15 mm female connector to the patient’s endotracheal tube.
Figure 10-3 d. Preparatory Step5
NOTE:
Alternatively, connect an HME (Heat Moisture Exchanger) between the patient’s
endotracheal tube and the IRMA probe. Placing an HME in front of the IRMA
probe protects the airway adapter from secretions and effects of water vapour and
eliminates the need of changing the adapter. It allows free positioning of the IRMA
probe as well.
Figure 10-3 e. HME option
6. Unless the IRMA probe is protected with an HME always position the IRMA sensor with the
indicator pointing upwards.
Figure 10-3 f. Preparatory Step6

Pre-use check:
Before connecting the IRMA airway adapter to the breathing circuit, verify the O2 calibration by
checking that the O2 reading on the monitor is correct (21%).See Room air calibration section
for instructions on how to perform room air calibration.
Perform the tightness check of the patient circuit with the IRMA sensor head snapped on the
IRMA airway adapter.
Verify that there has not been any accumulation of gas between the IRMA sensor head and the
XTP windows by checking that the CO2 readings on the monitor are correct before connecting a
patient to the breathing circuit.
Check that the connections have been made correctly by verifying an actual CO2 waveform on
the monitor display.
NOTE:
There is no drift of measurement accuracy.
NOTE:
Variations in barometric pressure do not have any effects due to internal
barometric pressure compensation.
NOTE:
There is no adverse effects on stated performance due to cycling pressure of up to
10 KPa.
Room air calibration of oxygen sensor
Room air calibration of oxygen sensor will be performed automatically at regular intervals
whenever the IRMA sensor head is disconnected from the IRMA airway adapter.
If IRMA sensor is kept in operation for a long time period without being disconnected from the
airway adapter, or if the operating temperature for oxygen sensor changes significantly, the
IRMA sensor will indicate that a new room air calibration is required and the message will
appear on the screen.
Use the following procedure to perform a room air calibration of the sensor:
1. Disconnect the IRMA sensor from the airway adapter.
2. Wait until the indicator starts blinking with red light.
3. Snap the IRMA sensor back on the airway adapter.
4. Check that the indicator turns green.
5. While not connected to the breathing circuit, check that the O2 reading on the
monitor is 21%.
Gas span check:
Gas reading should be verified at regular intervals with a reference instrument. (It should be
done just by trained and authorized personnel of manufacturer.)
Warning
The device can only be operated by personnel who have passed professional training and
are familiar with this manual.

Warning
Don’t use the device in the environment which contains flammable anesthetic gas.
Warning
Before any interpretations are made of parameters readings and waveforms one, assure
that the multi-gas probe is functioning correctly. Partial obstruction of airway with water
can result in distorted waveforms. A leak in the airway may result in low parameters
measurements. Check the monitor to see if it is functioning properly.
Warning
Measurements can be affected by mobile and RF communications equipment. It should be
assured that the IRMA sensor is used in the electromagnetic environment specified.
Warning
Do not place the IRMA airway adapter between the ET tube and an elbow, as this may
allow patient secretions to block the adapter windows .
Figure 10-4 airway adapter connection
Warning
To keep secretions from pooling on the windows, position the IRMA airway adapter with
its windows in a vertical position and not in a horizontal position.
Figure 10-5. IRMA airway adapter position

NOTE:
Do not use the IRMA airway adapter with metered dose inhalers or nebulized
medications because this may affect the light transmission of the airway adapter
windows.
NOTE:
Do not apply tension to the sensor cable.
NOTE:
Do not operate the device at temperature outside operating range as a below:
IRMA ICU/OR/OR+: 10~35°C
IRMA AX/AX+: 10~40°C
IRMA CO2: 0~40°C
Warning
Verify sensor detection before starting GAS monitoring. Unplug the sensor from IRMA
connector to verify that the error message "NO SENSOR "is displayed.
Warning
Incorrect agent selection by the user for IRMA AX/OR (no automatic agent ID) will result
in false agent readings.
Warning
Using IRMA AX/OR (no automatic agent ID) with gas mixtures containing more than one
agent will result in false agent readings.
NOTE:
Replace the adapter if rainout/condensation occurs inside the airway adapter.
For more information of IRMA module refer to APPENDIX IV.

10.2 GAS WINDOW
NOTE:
After PHASEIN capnography probe is connected to the monitor, at first sensor type
(ISA or IRMA) is detected by the system and then displayed in front of the CO2
signal.
NOTE:
System displays Gas window for IRMA sensor as default. If when Gas window is
open ISA probe is connected to the system, by exiting this window and entering it
again you can change this window for ISA sensor. This change also can be made in
GAS ALARM window.
The GAS WINDOW menu is as follows:
Figure 10-6 GAS WINDOW
■ Co2 UNIT
Pick this item to adjust measurement unit. (Options: mmHg, KPa, %V)
Co2 in %V is the Co2 value (in mmHg) divided by ambient barometric pressure (in
mmHg) which is a percentage of the barometric pressure.
PEtCo 2 ( mmHg )
EtCo2(%V) =
p Brometric ( mmHg )
133.322 × PEtCo 2 ( mmHg )

EtCo2(KPa) =
1000
■ SIGNAL SWEEP
Available options for SIGNAL. SWEEP are 3, 6, 12/5 and 25mm/s.
■ SIGNAL SCALE
Depending on selected signal chooses by user different scale options is available as
following table:
CO2 Waveform Scale O2 Waveform Scale N2O Waveform Scale AA Waveform Scale

0-50 mmHg, 0-6% 0-50% 0-50%
1,2,3,5,10,20%
0-100 mmHg, 0-10% 0-100% 0-100%
<AUTOSCALE>
<AUTOSCALE> <AUTOSCALE> <AUTOSCALE>
AUTOSCALE is an option to adjust the scale automatically to display waveform in the best way.
■ WAVEFORM
Pick this item to select which gas waveform displays on the screen. Available Options are
CO2, N2O, O2, and AA.

■ COMPENSATE
The presence of oxygen and nitrous oxide can cause some interference in CO2
measurement. This is known as spectral broadening, and must be compensated.
N2O is measured and automatically compensated for in all IRMA sensors. Only when
IRMA2 (CO2) probe is connected to the monitor, N2O concentrates can be transmitted to
the sensor. Available options for COMPENSATE are 0-100%N2O.
The O2 compensation is performed automatically for all IRMA sensors with the oxygen
sensor available on it. When using an IRMA without an oxygen sensor, i.e. when oxygen
measurement is performed by the other device like anesthesia machines and ventilators
already equipped with O2 measuring devices, the current oxygen concentration should be
transmitted to the sensor
Available options for COMPENSATE are OFF and 1-100%O2 when O2 sensor is
available, it is "AUTO" and it doesn't change when O2 sensor is available.
■ GAS UNIT
Pick this item to adjust measurement unit for O2, N2O, AA (DES, HAL, ISO, ENF,
SEV) (Options: KPa, %V)
■ AGENT
In IRMA OR, Pick this item to select which anaesthesia agent values display on the
screen. Available Options are DES, HAL, ISO, SEV and ENF.
In IRMA OR+, there is automatic identification of anesthesia agent and it is "AUTO" in
menu and couldn't change.
NOTE:
In IRMA OR system will be able to monitor the anesthesia agent value when it
exceeds 0.2%.
NOTE:
In IRMA OR+, if the concentration of anesthesia agent doesn’t exceed agent
detection threshold, "AA?" will be displayed instead of the name of anesthesia agent
in Multi-gas parameters window.
NOTE:
In IRMA OR+, if there is two anesthesia agent mixtures in patient airway and their
concentration exceed agent detection thresholds, the message "AA1, AA2 AGENT
MIXTURE" is displayed on the screen and "MIX" is displayed instead of the name
of anesthesia agent in Multi-gas parameters window.

■ WORK MODE
Available options for WORK MODE are "standby" and "measure".
The default is "measure" mode .When gas monitoring is required, select "measure"
mode." standby" mode disables monitoring to decrease the power consumption and
extend the life cycles of IR source and IRMA sensor.
NOTE:
When not using gas monitoring functions, it is suggested to disconnect the sensor.
NOTE:
If the monitor doesn’t detect any CO2 signal for 30 minutes, after connecting IRMA
sensor, the monitor automatically disables gas monitoring to decrease the power
consumption and extend the life cycles of IR source and sensor. The monitor will be
set in "standby" mode.
NOTE:
If the monitor doesn’t detect adapter of IRMA sensor for 10 minute, after
connecting IRMA sensor, the monitor automatically disables monitoring to decrease
the power consumption and extend the life cycles of IR source and sensor. The
monitor will be set in "standby" mode.
NOTE:
When the system is in standby mode, you can enable GAS monitoring in GAS
window by setting work mode in measure.
■ GAS/RESP
Available options are "GAS" and "RESP" to select GAS or RESP as mode to monitor
RESP parameters .When selecting "GAS", the system will keep the current status. When
selecting "RESP", the system switches GAS module to standby mode, and toggle to
display RESP waveform and parameters.
■ FILL SIGNAL
Pick "ON" to show the waveform in a filled form.

■ ALARM
Pick "ALARM" in GAS WINDOW to call up the following menu:
Figure 11-7 GAS/ALARM WINDOW

Figure 10-7 GAS /ALARM WINDOW
■ GAS ALARM
indicator. Pick "OFF" to disable the alarm functions and there will be a " " symbol
■ ALARM LEVEL
Selectable between 1, 2. Level 1 represents the most serious case.
■ EtCO2 LIMIT
Alarm is activated when the EtCo2 exceeds adjusted ALARM HIGH value or
falls below adjusted ALARM LOW value. (Range: 0.4~13%V step0.1%V)
Default for upper limit is 6.5%V and for lower limit is 2.6%V.
■ FiCO2 HIGH
Alarm is activated when the FiCo2 exceeds adjusted ALARM HIGH value
(Range: 0.4~13 %V step 0.1%V), Default for upper limit is 1.3%V.
■ AWRR LIMIT
Alarm is activated when the AWRR exceeds adjusted ALARM HIGH value or
falls below adjusted ALARM LOW value.(Range :1-120BrPM step1BrPM)
Default for upper limit:
Adult: 30BrPM
Neonate: 60BrPM
Default for lower limit:
Adult: 5BrPM
Neonate: 15BrPM
■ APNEA LIMIT
Pick it to set the standard of judging an apnea case. It sets to 10 - 40 seconds,
increases/decreases by 5s and "OFF".
■ EtN2O LIMIT
Alarm is activated when the EtN2O exceeds adjusted ALARM HIGH value or
falls below adjusted ALARM LOW value. (Range: 1~100%V step1%V)

Default for upper limit is 75%V and for lower limit is 35%V.
■ FiN2O LIMIT
Alarm is activated when the FiN2O exceeds adjusted ALARM HIGH value or
■ EtAA LIMIT
Alarm is activated when the EtAA exceeds adjusted ALARM HIGH value or
falls below adjusted ALARM LOW value
■ FiAA LIMIT
Alarm is activated when the FiAA exceeds adjusted ALARM HIGH value or
NOTE:
FiAA and EtAA have different alarm ranges for every anesthesia agent as a follow:
Anesthesia agent Alarm range Step Alarm limit default

HAL 0.1~5% 0.1% 0.5~1.5%
DES 0.1~18% 0.1% 5~10%
ISO 0.1~5% 0.1% 0.8~2%
SEV 0.1~8% 0.1% 1~3%
ENF 0.1~5% 0.1% 0.5~1.5%
■ EtO2 LIMIT
Alarm is activated when the EtO2 exceeds adjusted ALARM HIGH value or
■ FiO2 LIMIT
Alarm is activated when the FiO2 exceeds adjusted ALARM HIGH value or
■ ZERO
Pick "ZERO" in GAS WINDOW to call up the following menu:
Figure 10-8 GAS/ZERO WINDOW

A zero reference calibration of the IR measurement should be performed whenever an offset in

gas reading is discovered or if "CO2 INVALID, PLEASE ZERO" alarms appear.
NOTE:
Zero reference calibration should only be performed by qualified service
technicians, and should NOT be a part of normal operating procedures.
The probe must work at least 15 minutes in measurement mode for warming up. Pressing zero
before passing this time, the message “UNABLE TO ZERO, SENSOR WARMING UP” will be
shown and zeroing procedure won’t be done.
Warning
For accurate measurements, IRMA sensor should be set zero to room air.
Warning
Incorrect probe zero calibration will result in false gas readings.
1. Select well ventilated room to perform the calibration.

2. Make sure the sensor is connected to system and no error message is displayed (except
APNEA)
3. Choose a < ZERO> in the ZERO WINDOW menu.
4. Press the rotary knob to start zeroing.
The message "PLEASE WAIT" will be displayed during the procedure. "ZERO IS OK."
indicates that the zeroing procedure is completed successfully.The last zeroing time will be
saved and displayed in its corresponding place.If an error happened during zeroing the error
message will be displayed in ZERO WINDOW.
Special care should be taken to avoid breathing into the adapter during the zero reference
calibration procedure. The presence of ambient air (21% O2 and 0%CO2) in the IRMA airway
adapter is of crucial importance for a successful zero reference calibration. Always perform a
pre-use check after performing zero reference calibration.

10.3 GAS Alarm Messages

Alarm is activated when parameters exceed adjusted alarm limits:

Respiration rate violates ●AWRR value blinks.
AWRR Alarm Activated
End Tidal Co2 violates ●EtCo2 value blinks.
EtCo2 Alarm Activated
FiCo2 High FiCo2 violates adjusted high ●FiCo2 value blinks.
Activated
Alarm alarm limits ●Alarm indicator flashes
Non-respiration condition ●Alarm indicator flashes.
RESP APNEA Activated
overruns adjusted time ●"RESP APNEA" blinks.
End Tidal Co2 violates ●EtN2O value blinks.
EtN2O Alarm Activated
End Tidal Co2 violates ●FiN2O value blinks.
FiN2O Alarm Activated
End Tidal Co2 violates ●EtAA value blinks.
EtAA Alarm Activated
End Tidal Co2 violates ●FiAA value blinks.
FiAA Alarm Activated
End Tidal Co2 violates ●EtO2 value blinks.
EtO2 Alarm Activated
End Tidal Co2 violates ●FiO2 value blinks.
FiO2 Alarm Activated

GAS messages include:
Message Cause Solution Explanation

Turn the system off and
Alarm level 2. Pressing alarm
on and if problem still
SYSTEM FAULT Sensor error Silence, Alarm will be
exists, contact after sales
service of manufacturer.
Alarm level 2. Pressing Alarm
REPLACE ADAPTOR IR signal low Change adapter silence, alarm is suspended for
at least 120S
There is no adaptor connect
NO ADAPTOR Connect adapter Silence, Alarm will be
to the sensor.
Zero the sensor, if the
problem still exists, turn
off and on the system and Alarm level 2. Pressing alarm
CO2 outside specified
CO2 INVALID. if again this message Silence, Alarm will be
accuracy range.
appears contact after disabled and ignore this fault.
sales service of
manufacturer.
O2 outside specified
O2 INVALID. if again this message Silence, Alarm will be
accuracy range.
sales service of
manufacturer.
N2O outside specified
N2O INVALID. if again this message Silence, Alarm will be
accuracy range.
sales service of
manufacturer.
Agent outside specified
AGENT INVALID if again this message Silence, Alarm will be
accuracy range.
sales service of
manufacturer.
problem exists again turn
ACCUTACY off and on the system and Alarm level 2. Pressing alarm
Two or more agent are out of
INVALID, PLEASE if again this message Silence, Alarm will be
accuracy range except O2
ZERO. appears contact after disabled and ignore this fault.
sales service of
manufacturer.
Alarm level 2 . Pressing alarm
INVALID AMBIENT Ambient pressure outside on and if problem still
Silence, Alarm will be
PRESSURE operating range. exists, contact after sales
disabled for 120 sec.
INVALID AMBIENT Internal temperature outside on and if problem still
TEMPERATURE operation range. exists, contact after sales
Adapter O2 port Clogged or
O2 PORT FAILURE Change the adapter. silence, alarm is suspended for
plugged.
at least 120S


REPLACE O2 O2 sensor lifetime is passed.. Place new O2 sensor
disabled and will ignore this
SENSOR
fault.
If the sensor operate for a
long time period without
ROOM AIR O2 being disconnected from the Perform room air
silence, alarm is suspended for
CALIB REQUIRED adapter or the operating calibration.
at least 120S.
temperature for oxygen
sensor changes significantly
Connect sensor if
Alarm level 3 Pressing alarm
Sensor is disconnected from problem exist again,
NO SENSOR Silence, Alarm will be
system Contact after sales
Manual setting and if no
breath is detected for 30 min
and ETCO2 is less than 4
SENSOR STANDBY
mmHg for more than 30 min
MODE
or when the monitor does not
detect adapter of IRMA
sensor for 10 min.
- The accuracy of the agent
identification and
measurement could not be
guaranteed.
- More than 2 aesthetic
agents are present in the
AGENT ID
breathing circuit
UNRELIABLE*
- High concentrations of
solvents, cleaning agents
or other interfering gases
are present in the
breathing circuit
* Only available for IRMA AX+/OR+
Indicator status on the IRMA sensor head:
Steady green light System OK

Blinking green light (IRMA Zero Reference check in
AX+/OR+ only) progress
Steady red light Sensor error
Blinking red light Check adapter
Blinking green light Standby mode

10.4 IRMA SENSOR CLEANING

1. The IRMA sensor can be cleaned using a cloth moistened with ethanol or isopropyl alcohol.
2. Do not reuse, sterilize, or clean airway adapter on another patient as they are designed for
single use.
Warning
The IRMA oxygen sensor cell and IRMA airway adapters are non-sterile devices. Do not
autoclave the devices as this will damage them.
Warning
Never sterilize or immerse the IRMA sensor in liquids.
10-20
11 GAS Monitoring (Sidestream)
11-1 GENERAL
GAS monitoring provides a continuous waveform of airway gas concentration as a function of
time. The waveform enables physician to evaluate adequacy of gas exchange in the lungs,
integrity of the patient’s airway, cardiopulmonary function and ventilator function.
Vital sign monitor uses sidestream method for gases measurement.

A Nomoline sampling line is connected to patient respiratory circuit in ISA analyzers for
monitoring of inhaled and exhaled gases during anesthesia, recovery or respiratory cares. ISA
sensors may be used in operation room, ICU or patient room for emergency medical services or
transportation emergency and they are applicable for neonates and adults.
Different configurations of this sensor are available in the market. These sensors have ability to
identify different gases as CO2, N2O and five anesthetic gases (Halothane, Enflurane,
Isoflurane, Sevoflurane and Desflurane) by parameters as respiratory rate, waveform and
concentration of inhaled/exhaled gases.
Different types of the sensor are as follows:
ISA CO2: CO2
ISA AX +: CO2, N2O, two anesthetic agent (DES, SEV, ENF, ISO and HAL), MAC and
Automatic agent identification
ISA OR +: CO2, O2, N2O, two anesthetic agent (DES, SEV, ENF, ISO and HAL), MAC and
Automatic agent identification
Measuring principle
Gas monitoring uses infrared (IR) spectroscopy method to measure and identify different gases.
Infrared spectroscopy is used to measure the concentration of molecules that absorb infrared
light. Since the absorption is proportional to the concentration of gas molecule, the concentration
can be determined by comparing its absorption.
For ISA AX+ or ISA OR+ sensor, absorption of nine different wavelengths of infrared light is
measured in order to identify the gases and measure their concentrations.
The measurement of CO2, N2O and anaesthetic agents in the breathing gas mixture is based on
the fact that the different gases absorb infrared light at specific wavelengths.

A microprocessor continuously calculates the CO2, N2O and anesthetic agent concentrations
from the infrared light absorption measurements using matrix calculations to identify which
anesthetic agents are present in the gas mixture.
Measurable parameters by ISA sensor are:

EtCO2, EtN2O, EtAA (End tidal of these gases), FiCO2, FiN2O and FiAA (Fraction inspiratory
of these gases) and Air Way Respiratory Rate and MAC.
NOTE:
It takes less than 10 seconds to display gas waveform data and 1 minute that the
accuracy and other operating specification of the system comply with technical
specification in chapter 19.
Warning
ISA probe is intended for use only as an adjunct in patient assessment .It must be used in
conjunction with clinical signs and symptoms.
Warning
ISA probe should be connected only to approved devices of PHASEIN Company.
MAC (Minimum alveolar concentration)
Minimum alveolar concentration or MAC is a concept used to compare the strengths of

anesthetic vapors; in simple terms, it is defined as the concentration of the vapor in the lungs that
is needed to prevent movement (motor response) in 50% of subjects in response to surgical
(pain) stimulus.
The MAC value may be calculated and displayed by using end-tidal (ET) gas concentrations
according to the following formula:
MAC = %ET (AA1)/X (AA1) + %ET (AA2)/X (AA2) + %ET (N2O)/100

X(AA): HAL=0.75%, ENF=1.7%, ISO=1.15%, SEV=2.05%, DES=6.0%
NOTE:
The patient age as well as other individual factors is not taken into account in the
above described formula. ET gas concentrations for secondary agent (AA2) are only
available for ISA (Multi-gas) probe.

Sampling Line
ISA sidestream analyzer continuously removes sampled gas from respiratory circuit (Nasal
cannula, respiration mask or Y-piece connected to breathing tube). Sampled gas enters the
analyzer through the sampling line; it is usually warm and humid and cools down in contact with
the walls of a sampling line and condenses in form of water droplets. These droplets could
occlude the sampling line and interfere with gas measurements.
Nomoline sampling line protects ISA sidestream analyzer from these problems.
Unlike traditional methods that remove water vapor and collect it in a container, Nomoline
removes water and water vapor by a water separation section in a unique method. This section
made of a special polymer and bacterial filter that removes water vapor and condenses it and
passes through a membrane surface while has no effect on CO2 and anesthetic agents.
Nomoline sampling line has a lock connector through which can be connected to Nasal cannula.
ISA sensor goes to Standby mode when sampling line is not connected to it, as soon as the
sampling line is connected to ISA sensor; it turns on and starts measurement.
Nomoline has rapid response time that it makes CO2, N2O, and anesthetic agents measurement
possible even at high respiratory rates. ISA analyzer is applicable for adults, pediatrics and
neonates.
Warnings related to sampling line
Warning
Do not use sampling line if it or its package is damaged and return it to the vendor.
Warning
Use only the recommended ISA sampling line by the manufacturer. Other sampling lines
may cause sensor improper performance. (Refer to chapter 20 for more detail)
Warning
Disposable sampling lines shall not be reused .Used sampling lines shall be disposed of in
accordance with local regulations for biologically hazardous materials.
Warning
If sampling line is connected to the patient for a long time period, you should replace it
every two weeks or when “Sampling line clogged” message is displayed. (Each one happens
earlier)

Warning
Do not place sampling line in a way that it is tangled around the patient neck and cause
suffocation.
Warning
Do not use the adult/pediatric sampling line with infants as the sampling line adds dead
space to the patient circuit.
Warning
Do not use the infant sampling line with adults as this may add excessive flow resistance to
patient breathing circuit.
The infant sampling line has designed in a way that minimizes the dead space and can be used
even for very small patients.
Warning
Don not use ISA probe with artificial breathing devices or Nebulizer as this may cause
bacterial filter occlusion.
Warning
Never use a syringe to extract settled water in Nomoline.
Preparatory steps for Multi-gas monitoring (Figure 11-3)
1. Plug the ISA sensor into corresponding connector on the side panel of patient monitor.
2. Snap the sampling line head on the ISA sensor. It will click into place when properly
seated.
3. About ISA AX+ or ISA OR+, connect exhaust of sampled gases to a collection system or
restore them again to patient breathing flow.
4. Power on the monitor.
5. A green indicator indicates that the ISA sensor is ready for use.
6. Connect the ISA sampling line to the patient’s endotracheal tube.

Pre-use check
Before connecting the sampling line to the breathing circuit, perform following steps to ensure
accuracy of patient circuit connections.
1. Snap the sampling line head on the ISA sensor.

2. A green indicator on ISA sensor indicates that it is ready for use.
3. For ISA OR+ sensor, check that O2 reading on the monitor is 21%.
4. Breathe into the sampling line to check that displayed CO2 value and waveform on the
monitor are correct.
5. Occlude the sampling line by your finger and wait for 10 sec.
6. Check if occlusion message is displayed on the monitor and ISA sensor indicator flashes in
red.
7. Verify that sampling line is connected to patient’s breathing tubes securely.
NOTE:
There is no drift of measurement accuracy.
NOTE:
Variations in barometric pressure do not have any effects due to internal
barometric pressure compensation.
NOTE:
There are no adverse effects on stated performance due to cycling pressure of up to
10 KPa.
Warning
Warning
Don’t use the device in the environment which contains flammable anesthetic gas.
Warning
Before any interpretations are made of EtCo2 reading and waveform, assure that the
capnography system is functioning correctly. Monitor contamination by secretions and
Partial obstruction of sampling line with water can result in distorted CO2 waveforms. A
leak in the sampling line may result in low EtCo2 measurements. Check the monitor to see
if it is functioning properly.
Warning
Don not expose the monitor with sidestream capnography module to vibration and impact.

Warning
assured that the ISA sensor is used in an environment without electromagnetic radiations.
Warning
Do not use ISA probe during magnetic resonance imaging (MRI) scanning. Therefore
transfer it outside the MIR room.
Warning
Using electro surgery devices (High frequency equipments) adjacent to ISA probe may
cause measurement interference.
NOTE:
Do not apply tension to the ISA sensor cable.
NOTE:
Do not operate the ISA sensor at temperature outside operating range as a below:
ISA CO2: 0~50°C
ISA OR+/ AX+: 5~50°C
Warning
Verify ISA sensor detection before starting GAS or CO2 monitoring. Unplug the ISA
sensor from its connector to verify that the error message "NO SENSOR "is displayed.
NOTE:
Refer to APPENDIX VI for more information about ISA module.
Warning
Positioning the monitor lower than the patient may facilitate condensed water and
secretions move towards the system thereby resulting in blockage of filters. Keep the
system preferably above the patient level. This prevents secretions and water dribbling
down the tube towards the monitor end and extends the lifetime of the filters.
Zeroing procedure
ISA gas analyzer should have a reference zero level for CO2, N2O and anesthetic agent
measurement that this calibration process is called zeroing.
ISA probe automatically perform zeroing procedure by switching the sampling line from
respiratory tubes.

Automatic zeroing procedure is performed one to three times every 24 hours. It takes up to 3 sec
to perform zeroing for ISA (CO2) probe and up to 10 sec for ISA (Multi gas). After zeroing
procedure is completed, a flat line signal and message “ZEROING IN PROGRESS” will be
displayed.
If ISA probe is used accompanied by oxygen sensor, in automatic zeroing room air will be used
for O2 sensor calibration.
Warning
Special care should be taken to avoid breathing into the adapter during the zero reference
calibration procedure. The presence of ambient air (21% O2 and 0%CO2) in the ISA
probe is of crucial importance for a successful zero reference calibration.
NOTE:
Use manufacturer especial fasteners to connect ISA sensor to the infusion stand.
11-2 GAS WINDOW
NOTE:
After PHASEIN capnography probe is connected to the monitor, at first sensor type
(ISA or IRMA) is detected by the system and then displayed in front of the CO2
signal.
NOTE:
System displays Gas window for IRMA sensor as default. If when Gas window is
open ISA probe is connected to the system, by exiting this window and entering it
again you can change this window for ISA sensor. This change also can be made in
GAS ALARM window.
The GAS WINDOW is as follows:
Figure 11-1 GAS WINDOW

■ Co2 UNIT
Pick this item to adjust CO2 measurement unit. (Options: mmHg, KPa, %V)
EtCo2 in %V is the EtCo2 value (in mmHg) divided by ambient barometric pressure (in
mmHg) which is a percentage of the barometric pressure.
PEtCo 2 ( mmHg )
EtCo2(%V) =
p Brometric ( mmHg )
133.322 × PEtCo 2 ( mmHg )

EtCo2(KPa) =
1000
■ SIGNAL SWEEP
Select it to adjust Multi-gas signals sweep. Available options for SIGNAL SWEEP are 3,
6, 12/5 and 25mm/s.
■ SIGNAL SCALE
Depending on selected signal chosen by user different scale options is available as
following table:
CO2 Waveform Scale O2 Waveform Scale N2O Waveform Scale AA Waveform Scale
0-50 mmHg, 0-6% 0-50% 0-50%
1,2,3,5,10,20%
0-100 mmHg, 0-10% 0-100% 0-100%
<AUTOSCALE>
<AUTOSCALE> <AUTOSCALE> <AUTOSCALE>
AUTOSCALE is an option to adjust the scale automatically to display waveform in the best way.
■ WAVEFORM
Pick this item to select which gas waveform displays on the screen. Available Options are
CO2, N2O, O2, and AA.
■ O2 COMPENSATE
The presence of oxygen can cause some interference in CO2 measurement. This is
known as spectral broadening, and must be compensated.
The O2 compensation is performed automatically for all ISA sensors with the oxygen
sensor available on it. When using an ISA without an oxygen sensor, i.e. when oxygen
measurement is performed by the other device like anesthesia machines and ventilators,
the current oxygen concentration should be transmitted to the sensor
Available options for COMPENSATE are OFF and 1-100%O2 when O2 sensor is
available, it is "AUTO" and it doesn't change when O2 sensor is available.

■ N2O COMPENSATE
The presence of N2O can cause some interference in CO2 measurement. This is known
as spectral broadening, and must be compensated.
N2O is measured and automatically compensated for in ISA sensors (AX+/OR+).
Therefore N2O concentration should be transmitted to ISA sensor (CO2).
Available options are 0-100%.
NOTE:
You can see this item only when ISA (CO2) sensor is connected to the system. In other
modes (ISA AX+/OR+), this item is removed from the respective menu. In other words
CO2 menu for ISA (CO2) and IRMA (CO2) is similar except for N2O COMPENSATE
option.
■ GAS UNIT
Pick this item to adjust measurement unit for O2, N2O, AA (DES, HAL, ISO, ENF,
SEV) (Options: KPa, %V)
■ AGENT
In ISA AX+/OR+, there is automatic identification of anesthesia agent and "AUTO" is
displayed in menu and couldn't change.
NOTE:
In IRMA OR+, if the concentration of anesthesia agent doesn’t exceed agent
detection threshold, "AA?" will be displayed instead of the name of anesthesia agent
in Multi-gas parameters window.
NOTE:
In ISA OR+, if there is two anesthesia agent mixtures in patient airway and their
concentration exceed agent detection thresholds, the message "AA1, AA2 AGENT
MIXTURE" is displayed on the screen and "MIX" is displayed instead of the name
of anesthesia agent in Multi-gas parameters window.
■ WORK MODE
Available options for WORK MODE are "standby" and "measure".
The default is "measure" mode .When gas monitoring is required, select "measure"
mode." standby" mode disables monitoring to decrease the power consumption and
extend the life cycles of IR source and ISA module.
NOTE:
When not using gas monitoring functions, it is suggested to disconnect the sensor.

NOTE:
If the monitor doesn’t detect any CO2 signal for 30 minutes, after connecting ISA
sensor, the monitor automatically disables gas monitoring to decrease the power
consumption and extend the life cycles of IR source and sensor. The monitor will be
set in "standby" mode.
NOTE:
Sensor remains in standby mode until the sampling line is connected to ISA sensor.
After sample line connection the sensor switches on and starts measurement.
NOTE:
For enabling ISA sensor, you can enter Gas window and set the monitor on measure
mode.
■ GAS/RESP
Select this item to determine that respiration evaluation is performed by "Multi-gas"
or"RESP" module. Available options are "GAS" and "RESP". When selecting "RESP",
the system switches Multi-gas module to standby mode, and displays RESP waveform
and parameters.
■ FILL SIGNAL
Pick "ON" to show the waveform in a filled form.

■ ALARM
Pick "ALARM" in GAS WINDOW to call up the following menu:
Figure 11-2 GAS/ALARM WINDOW
■ GAS ALARM
indicator. Pick "OFF" to disable the alarm functions and there will be a " " symbol in
Multi-gas Parameters Area.
■ ALARM LEVEL
Selectable between 1, 2. Level 1 represents the most serious case.
■ EtCO2 LIMIT
Alarm is activated when the EtCo2 exceeds adjusted ALARM HIGH or LOW limit
(Range: 0.4~13%V step0.1%V)
Default for upper limit is 6.5%V and for lower limit is 2.6%V.
■ FiCO2 HIGH
Alarm is activated when the FiCo2 exceeds adjusted ALARM HIGH limit
(Range: 0.4~13 %V step 0.1%V), Default for upper limit is 1.3%V.
■ AWRR LIMIT
Alarm is activated when the AWRR exceeds adjusted ALARM HIGH or
LOW limit. (Range: 1-120BrPM)
Default for upper limit:
Adult: 30BrPM
Neonate: 60BrPM
Default for lower limit:
Adult: 5BrPM
Neonate: 15BrPM
■ APNEA LIMIT
Pick it to set the standard of judging an apnea case. It sets to 10 - 40 seconds and "OFF"
andincreases/decreases by 5s.

■ EtN2O LIMIT
Alarm is activated when the EtN2O exceeds adjusted ALARM HIGH or LOW limit.
(Range: 1~100%V step1%V)
■ FiN2O LIMIT
Alarm is activated when the FiN2O exceeds adjusted ALARM HIGH or LOW limit.
■ EtAA LIMIT
Alarm is activated when the EtAA exceeds adjusted ALARM HIGH or LOW limit.
■ FiAA LIMIT
Alarm is activated when the FiAA exceeds adjusted ALARM HIGH or LOW limit.
NOTE:
FiAA and EtAA have different alarm ranges for every anesthesia agent as a follow:
Anesthesia agent Alarm range Step Alarm limit default

HAL 0.1~5% 0.1% 0.5~1.5%
DES 0.1~18% 0.1% 5~10%
ISO 0.1~5% 0.1% 0.8~2%
SEV 0.1~8% 0.1% 1~3%
ENF 0.1~5% 0.1% 0.5~1.5%
■ EtO2 LIMIT
Alarm is activated when the EtO2 exceeds adjusted ALARM HIGH or LOW limit.
Default for upper limit is 100% and for lower limit is 50%.
■ FiO2 LIMIT
Alarm is activated when the FiO2 exceeds adjusted ALARM HIGH or LOW limit.

11.3 ISA Sensor Alarm Messages

Alarm is activated when Gas parameters exceed adjusted alarm limits:

Respiration rate violates ●AWRR value blinks.
AWRR Alarm Activated
End Tidal Co2 violates ●EtCo2 value blinks.
EtCo2 Alarm Activated
FiCo2 High FiCo2 violates adjusted high ●FiCo2 value blinks.
Activated
Alarm alarm limits ●Alarm indicator flashes
Non-respiration condition ●Alarm indicator flashes.
APNEA Activated
overruns adjusted time ●"RESP APNEA" blinks.
End Tidal Co2 violates ●EtN2O value blinks.
EtN2O Alarm Activated
End Tidal Co2 violates ●FiN2O value blinks.
FiN2O Alarm Activated
End Tidal Co2 violates ●EtAA value blinks.
EtAA Alarm Activated
End Tidal Co2 violates ●FiAA value blinks.
FiAA Alarm Activated
End Tidal Co2 violates ●EtO2 value blinks.
EtO2 Alarm Activated
End Tidal Co2 violates ●FiO2 value blinks.
FiO2 Alarm Activated

GAS messages include:
Message Cause Solution Explanation

on and if problem still
SYSTEM FAULT Sensor error Silence, Alarm will be
exists, contact after sales
CHECK SAMPLING
IR signal low Change sampling line silence, alarm will be disabled
LINE
Remove obstruction
SAMPLING LINE otherwise change the
Sampling line occlusion Silence, Alarm will be
CLOGGED sampling line by a
disabled for 120sec.
correct one.
CO2 INVALID if again this message Silence, Alarm will be
accuracy range.
sales service of
manufacturer.
O2 outside specified problem still exists,
O2 INVALID Silence, Alarm will be
accuracy range. contact After sales
N2O outside specified problem still exists,
N2O INVALID Silence, Alarm will be
Agent outside specified problem still exists,
AGENT INVALID Silence, Alarm will be
ACCUTACY Alarm level 2. Pressing alarm
Anesthesia agents are out of problem still exists,
INVALID, PLEASE Silence, Alarm will be
accuracy range except O2 contact After sales
ZERO. disabled and ignore this fault.
INVALID AMBIENT Ambient pressure outside on and if problem still
PRESSURE operating range. exists, contact after sales
INVALID AMBIENT Internal temperature outside on and if problem still
TEMPERATURE operation range. exists, contact after sales
REPLACE O2 Replace O2 sensor by a Silence, Alarm will be
O2 sensor lifetime is passed.
SENSOR new one. disabled and will ignore this
fault.
Replace O2 sensor by a
O2 SENSOR ERROR Sensor failure Silence, Alarm will be
new one.
O2 SPAN CALIB being disconnected from the Perform room air
silence, alarm is suspended for
REQUIRED sampling line or the operating calibration.
120S.
temperature for oxygen
sensor changes significantly

CO2 value is more than 800 Perform automatic

ZERO REFERENCE PPM (0.80%V) and zeroing procedure in an
CALIB REQUIRED measurement accuracy is environment with CO2
low. less than 0.80%V.
Connect sensor if
Alarm level 3 Pressing alarm
NO SENSOR Silence, Alarm will be
system Contact after sales
Manual setting and if no
breath is detected for 30 min
SENSOR STANDBY and ETCO2 is less than 4
MODE mmHg for more than 30 min
or when the monitor does not
detect the sampling line.
identification and
measurement could not be
guaranteed.
AGENT ID
breathing circuit
UNRELIABLE2
- High concentrations of
are present in the
breathing circuit
2
Only available for ISA AX+/OR+
Indicator status on the ISA sensor:
Steady green light System OK

Blinking green light Zero Reference check in progress
Blinking blue light There are anesthesia agents
Steady red light Sensor error
Blinking red light Check sampling line

11.4 ISA SENSOR CLEANING

1. The ISA sensor should be cleaned regularly by using a cloth moistened with ethanol or 70%
isopropyl alcohol.
2. Connect the sampling line to the corresponding connector on the ISA sensor when you clean
the sensor to prevent dust and liquid entering.
Warning
The ISA sampling line is non-sterile device. Do not autoclave the devices as this will
damage them.
Warning
Never sterilize or immerse the ISA sensor in liquids.

12 Cerebral State Monitoring

12.1 GENERAL
The Cerebral State Monitor (CSM) is a non-invasive measurement tool for use by trained
professionals to measure the level of consciousness (LOC) in all area of the hospital .Based on
EEG, an index (CSI) is calculated, which is used in the estimation of LOC. The CSM module
displays the CSI but does not perform any data interpretation. All data interpretation is
performed by a physician.
The monitor is intended for use in monitoring the hypnotic state of the brain by data acquisition
of EEG signals of the anesthetized or sedated patient in all areas of the hospital.
Measuring principle
An instrumentation amplifier collects ongoing EEG with a high Common Mode Rejection Ratio
ensuring a high-quality EEG acquisition. Special algorithms that eliminate their effects on
subsequent CSI calculations detect artefacts.
The performance of the CSI is based on the analysis of the frequency content of the EEG signal.
The energy of the EEG is evaluated in specific frequency bands. These are used to define two
energy ratios called alpha (α) and beta (β). Both of these show a shift in energy content from the
higher to the lower frequencies during anaesthesia. The relationship between these quantities is
also analysed as a separate parameter (β-α).
E30−42.5 Hz E30−42.5 Hz
α ratio = ln β ratio = ln
E6−12 Hz E11− 21Hz
The monitor also on-line evaluates the amount of instantaneous burst suppression (BS) in each
thirty-second period of the EEG. This measurement quantifies the amount of "silent" or "flat"
EEG periods characteristic of the deepest levels of hypnosis.
These four parameters are used as input to a fuzzy logic classifier system that calculates the
Cerebral State Index.
Figure 12-1 measurement principle

The measured parameters in csm monitor are CSI, BS, EMG and SQI as follow:
CSI Scale
The CSI is a unit-less scale from 0 to 100, where 0 indicates a flat EEG and 100 indicate EEG
activity corresponding to the awake state. The range of adequate anaesthesia is designed to be
between 40 and 60. All values in the table are approximate values based on the mean values of
the patient behaviour.
The relationship among the CSI, the clinical state and the OASS (Observers Assessment of
Alertness and Sedation) score is shown in the table below:
CSI Clinical State OAAS
90-100 Awake 5
80-90 Drowsy 4
60-80 Light anesthesia or sedation 3
40-60 Range considered as adequate for surgical 2-1
anesthesia
10-40 Deep anesthesia, in most cases accompanied 1
by burst suppression.
0-10 Close to coma, BS larger than 75 .When CSI <1
is below 3, the EEG is practically iso-electric.
The prediction probability (Pk) between the CSI and the OAAS was 0.92.
The OASS score correspond to:
OASS Clinical State
5 Respond readily to name spoken in normal tone.
4 Lethargic response to name spoken in normal tone.
3 Responds only after name called loudly and /or repeatedly.
2 Does not respond to mild prodding or shaking.
1 Does not respond to noxious stimulus.
EMG
High levels facial muscular or electromyographic (EMG) activity can interface with the CSI
under certain circumstance .The monitor incorporates an EMG filter that removes most of the
potential interfering EMG activity. The EMG bar shows the energy of the EMG level in the
75-85 Hz frequency band (0-100 logarithmic).
EMG activity is expected to be present when the patient is awake. When the patient is asleep,
EMG activity can increase due to:
● Reflex reactions to painful stimuli during surgery.
● Lack of muscular relaxation.
● Muscular rigidity caused by some opioids (analgesics).
● Presence of large external electrical fields, e.g. elector surgical unit.
The EMG bar should be checked frequently, especially in case of a sudden increase in the CSI. If
the increase in CSI is accompanied by an increase in muscular activity, there is a risk that EMG
is causing interference. When this happens, attention must be paid to the stimuli received by the
patient during surgery. In the presence of hypnotically unrelated EMG, administration of a
neuromuscular blocking agent will cause the CSI to decrease. Since patients receiving
neuromuscular blocking agents cannot exhibit movement as a sign of arousal, the CSI is a
valuable tool in their anaesthetic management.
Burst Suppression Indicator

The monitor include a Burst Suppression indicator to show periods when the EEG is iso-electric
or “flat” .The indication appears in the csm window and shows the percentage of burst
suppression over the last 30 seconds of EEG signal. A BS% =20 readouts means that the EEG
has been iso-electric during 20% of the last 30 seconds.

SQI Value (artifact and noise control)

The artefact rejection algorithm ensures that the incoming EEG is not contaminated with noise.
When excessive noise is detected, the signal quality is reduced reflecting the disturbance. The
artifact rejection algorithm will be active especially when electro surgical unit and equipment
creating external interference is used. When the SQI is 100, show that the EEG signal is in the
best quality.
Warning
Warning
The monitor will not render accurate readings when used on patients with severe
neurological disorders and patients under 2 years of age.
Warning
The monitor will not render accurate readings when used on patients weight less than 70%
or more than 130% of ideal body weight and recent use of psycho-active medication,
including alcohol
Warning
The use of pacemakers might cause either long periods of artifacts or elevated CSI values.
Warning
Do not use the monitor when cardiac defibrillator is used. Patient cables are not protected
against defibrillation.
NOTE:
Operating the monitor close to equipment radiating high-energy radio frequencies
(electrosurgical/cauterizing equipment, portable radios, cellular telephones, etc.)
may cause signal disturbance. If this happens, reposition the monitor away from the
source of interference.
Warning
When used with elector surgical unit please note the positioning of the neuro sensors. In
order to reduce the hazard of burns, the neuro sensors should not be located between the
surgical site and the electro surgical unit return electrode.
Warning
Not to be used in the presence of flammable gases; explosion risk.
Warning
Pay attention if the CSM monitor is connected to a patient connected to other equipment.
The total of leakage current may exceed the allowable limit and cause a possible hazard to
the patient.
Warning
The conductive parts of neuro sensor should not contact other conductive parts including
earth.

Warning
The monitor should be used in conjunction with other patient monitoring parameters and
clinical signs. This will ensure the optimum balance of the anesthesia/sedation
administration.
Warning
Do not open the CSM case. There are no user-serviceable parts inside. The case should only
be opened by qualified service personnel using proper grounding techniques. When the
case is opened, an electrical shock hazard exists which can result in serious injury to
persons and instrument component damage.
Skin Preparation and Sensor Positioning

To ensure low sensor impedance, clean skin with mild soap and water is recommended as a skin
cleanser.
NOTE:
Alcohol is not recommended as a skin cleanser; it leaves a film layer that may cause
high sensor impedance. If alcohol is used, ensure 30 second dry time.
The CSM Procedure Pack contains a skin preparation product and 3 neuro sensors.
NOTE:
The performance of the csm module is only guaranteed by the manufacture when
the CSM Procedure Pack is used.
Dry-abrading the skin gently using the skin prep product or with a dry wash cloth or gauze, to
remove the non conductive skin layer.
Positioning of the three neuro sensors is shown in figure12-2. The advanced signal processing of
the monitor ensures that a deviation in the positioning of the sensors up to 2 cm (0.78 in) has no
significant influence on the index. However, it is recommended to place the sensors on an area of
the skull where only a few muscle fibres are present in order to achieve the best quality signal.
Figure 12-2 Neuro Sensor Placement

White electrode (1) : middle of forehead
Green electrode (2) : left side of forehead
Black electrode (3) : mastoid of forehead

NOTE:
● Make sure no part of the neuro sensors is in contact with any other conductive parts
including earth/ground
● If skin rash or other unusual symptoms develop, remove sensors from patient.
● Change neuro sensors every 24 hours to check skin integrity.
Warning
Neuro sensors are disposable and should not be reused and before use attention to the
expiry date.
NOTE:
Once the neuro sensors have been secured on the skin, attach the colour-coded wires
on the patient cable to appropriate sensor.
NOTE:
Shown in figure 12-2 is a left sided setup; rights sided is also acceptable.
NOTE:
Place neuro sensors at the side farthest from the surgical area.
Picture below shows how to use neuro sensor.
Figure 12-3 Correct use of neuro Sensors

After opening the csm neuro sensors package, close the package like figure below. If you don’t
perform as figure below, the neuro sensors loose their quality.
Figure 12-4 Correct maintenance of neuro sensors in its package
Warning
Because the CSM patient cable are too thin pay attention not to subject them under
tension.
Warning
Use only the recommended CSM cable and neuro sensor for CSM monitoring. Other
accessory may cause improper performance. (Refer to chapter 20 for detail)
Warning
Do not repair defective CSM cables and send it for after sale service. Manufacturer does
not take responsibility for measurement accuracy of repaired cable.

12-2 CSM system

The monitor can show and record online csm data on the patient monitor for this reason it needs
CSM module. This part connects to patient monitor by wireless technology.
12-2-1 CSM module
Figure 12-5 CSM module

CSM module Key and control
Figure 12-6 CSM module Key and control

1.Power On
Press once
1.Power Off
Press and hold it for 5 seconds.
1. Wireless Link connection, disconnection or reconnection.
Press twice within 1 second
2.Red error light
Lights up when neuro sensor error situation are detected.
3. Green adapter.
Light when power adapter is connected.
4.Display area of csm module
5.Mute key mutes alarms
6.Set Event key /Set connection to patient monitor with CSM wireless card .
7.Display key
change between graphical and information screen
7a.For immediate impedance update. Press down firmly for one second.
8.Event key
Select event type /Select patient monitor with CSM wireless card among all.
9.Control key
Used for menu selection of parameter setting.
9a.Use the Control key to scroll in the menus or set values.
9b.Select a submenu or function
9c.Go back one menu level
CSM Module Setup Menu
Figure 12-7 CSM setup menu
How to select menu settings from Display Mode

1. Remove battery lid.
2. From any Display Mode, press any arrow on the Control key (9).
3. The upper menu appears.

How to set parameter values

1. Press the Control key (9a) to select menu.
2. Press the Control key (9b) to enter submenu.
3. Press the Control key (9a) to select parameter.
4. Press the Control key (9b) to highlight parameter value.
5. Press the Control key (9a) to select parameter value.
6. Press the Control key (9b) to store setting or (9c) to cancel the selection and return
without any change.
7. Press the Control key (9c) to go back in one menu level steps.
If the Control key has not been activated in 20 sec, the CSM module returns to Operation
Display Mode and stores the settings.
CSM Module Settings

Parameters Menu Description Value(Default)
High Alarm Alarm Selects the CSI Alarm High Option ON/OFF(OFF)
Low Alarm Alarm Selects the CSI Alarm Low Option ON/OFF(OFF)
High Limit Alarm Selects the CSI High Alarm Level 2-99(60)
Low Limit Alarm Selects the CSI Low Alarm .Level 1-98(25)
Language Config Selects device language English
Contrast Config Selects display contrast 15-35(22)
Select radio link active. If turned OFF the link is
RF interface Config ON/OFF(ON)
completely inactive.
Sets clock :Date format, Year, Month, Date,
Set clock Config -----
Hours, Minutes, Seconds
0=Off
Backlight Config Set display light and light brightness (1=Normal)
2=Bright
Automatically established a wireless link to any Inactive/Active/SN
monitor with CSM wireless card within approx. (Inactive)SN is
AutoLNK Config
10 meters or to specified monitor with CSM only displayed if
wireless card. link is established.
Device Information Menu
Figure 12-8 Device Information Menu
This menu shows some extra information about the csm module.

Events Menu
Pressing the Event Type key brings up the following selection menu:
Figure 12-9 Event Menu
The following options can be selected: Induction, Intubation, Maintenance, Surgery, Injection,
Note, End Maintenance, and Movement.
When the desired option has been selected, press the Set Event key (6) to confirm. If no selection
is made within 5 seconds the system returns to the current Display Mode. Only the event
numbers are visible on Display Mode C. When you set event this event will be shown in csm
trend of patient monitor.
Event can be set with interval of 3 seconds.
CSM module display modes

The CSM module always starts with display A
Switch between display A, B, C, D and E by pressing the Display key (7).
Figure 12-10 CSM module display mode A

Main information window with CSI, BS%, EMG%, SQI%, clock, operation time and battery
operation
Figure 12-11 CSM module display mode B

Displays 3 seconds of EEG waveform. Use Event key (8) to scale up and down. EEG scales are
±200µV, ±100µV (default), ±50µV, ±20µV and ±10µV.

Figure 12-12 CSM module display mode C

CSI trend curve with event markers. EMG% is displayed as a bar in the right panel. Operation
time and numeric value of the actual CSI and BS%. The time scale for the trend curve is 5.27
minutes and each tag is 60 seconds
Figure 12-13 CSM module display mode D

CSI trend histogram with 5-minute interval showing average, lowest and highest CSI values
within the interval. EMG% is displayed as a bar in the right panel.
Figure 12-14 CSM module display mode E

Sensor impedance, CSI, BS%, clock and operation time. When display E is active, the sensor
impedance is updated every 60 seconds. Press Display key (7a) firmly for immediate impedance
update.
The EEG waveform derives from the signal recorded between the frontal and mastoid electrodes.
The frequency content is 2-35 Hz.
An icon labelled “LNK” in display mode E indicates the state of the data transfer connection via
the csm link.
An icon labelled “BAT” in display mode A indicates the remaining battery capacity.
Battery 50 % charged
Battery charging when icon animated
Battery fully charged (if not animated)

The CSM module can be operated in two different modes, Batteries operated and CSM power
operated.
Warning
Only standard csm rechargeable battery CSMX04 or alkaline batteries must be used.
NOTE:
● Always use new Alkaline batteries to ensure best results
● Insert battery correctly
Warning
Only use recommended adapter in this manual for charging the battery.
NOTE:
There is no alarm if battery is not connected. If no battery is inserted, the csm
module is switched off when the external csm power is removed. There is no internal
backup battery in the monitor.
NOTE:
The clock is powered by an internal battery with a limited life (minimum 6 years
from date of manufacture).When the battery is used up, the clock will be reset, and
the click will blink on start up. The csm module should then be sending for service.
Rechargeable battery’s useable time (fully charged CSMX04 only)
Wireless link Backlight level useable time (hours)

OFF OFF 10.5
OFF 1 9.0
OFF 2 7.0
ON OFF 10.0
ON 1 8.5
ON 2 6.5
NOTE:
Using 9V alkaline disposable batteries, the batteries use time indicates in table
above can be multiplied by 2 to 3.

Figure 12-15 CSM module battery charging
1. Insert the CSM rechargeable battery as indicated.

2. Connect power cable to outlet and turn on power.
3. Green indicator (3 at figure 12-6) lights up.
4. Turn on csm module
5. When the CSM module is connected to an electrical outlet, and turned on, the CSM module
can be operated while the battery is charged. If power is disconnected the CSM will continue
running on the CSM battery.
NOTE:
The CSM module can be operated on mains with the CSM Power, with or without
any type of approved battery inserted.
NOTE:
When csm rechargeable battery (CSMX04) is used, it will charge automatically
while the electrical power is connected. Only csm battery (CSMX04) will be charged
in the CSM module.

12-2-2 CSM on patient monitor

1-Turn on the csm module.
2-The CSM module shows a list of monitor with CSM wireless card found. Select the ID of
desired monitor with the Event key on the CSM module and the “CSM LINK” status
indicator at right side of panel flashes.
3-Accept the desired monitor by pressing the Set key. When link has been established the
“CSM LINK” status indicator will show a constant light.
4-The communication is performed and you can see csm parameters like CSI%, BS%, SQI%,
EMG% and also EEG signal on the patient monitor display.
CSM patient monitor display

When highlight is place at CSM area, press the knob, the following window (csm large page)
will pop up:
Figure 12-16 CSM large page
This window is a special page for CSM display to show detail information of csm parameters in
lager area and also you can change the different settings of csm on it.
■ To enable or disable trend graph of BS parameter:
Pick the most left item to enable or disable the BS trend.
■ To enable or disable trend graph of SQI parameter:
Pick the second left item to enable or disable the SQI trend.
■ To enable or disable trend graph of EMG parameter:
Pick the third left item to enable or disable the EMG trend.
NOTE:
The CSI parameter trend always shows on this page and the user is not able to
disable displaying of it.

■ To select how long the trend graph is displayed:

Pick the forth left item, available options are 15min, 30min and 1-24H by the step of 1H.
While the cursor line has not moved in csm large page, every click on forth left item, the x scale
will be displayed based on the chosen trend interval till current time.
Moving the cursor to chose a specific time and pressing trend time interval item (the forth left
item), x scale will be zoomed in and zoomed out equal to the trend interval according to the
specific time the cursor line shows.
■ To obtain trend data of specific time:
Cursor line in trend graph shows specific time. You can move the cursor line to change the time
by pressing the fifth left item, when trend time interval (the forth left item) is set at 15 min, 30
min, 1H and 2H and turning the knob. Parameters at mentioned time are displayed on the right
side of the csm large page with its specific color.
■ To select time interval of trend in x-axis:

Pick” “(the sixth left item) to adjust the start time and stop time of x-axis. By every
clicking on the “ ”, the x scale will be changed in extend of the specified time of forth left
item
■ To change EEG gain:

Pick “EEG GAIN” (the seventh item left) to adjust the Y scale of EEG signal and thus change
the EEG signal in proportion. Available options are 25µV and 50-250µV by step 50µV.
■ To review the event:

Patient monitor can review the 255 csm event data.
Pick “EVENT LIST” to invoke the result and time of latest event data, CSM/EVENT LIST
WINDOW will pops up as shown in figure below:
Figure 12-17 CSM/EVENT LIST WINDOW
By pressing the first left item of EVENT LIST WINOW, you can select a line of event recorded
data and you will be able to delete a line of data in EVENT LIST WINDOW by pressing
“DELET”. And all event list for new patient bye pressing “DELETE ALL”

NOTE:
For every event there is an event mark at specific time of trend when trend time
interval is set at 15 min, 30 min, 1H and 2H
■ To enable or disable the csm alarm limit:

Pick “CSM ALM ON/OFF” to enable CSI alarm function such as parameters blinking, audio
alarm and light indicator. Pick”OFF” to disable the alarm functions and there will be a will be a
" " symbol instead of alarm limits in Parameters Area.
■ To set the CSI alarm limit:

Press the 10th left item to set the CSI limit. Alarm is activated when the CSI parameter exceeds
adjusted ALARM HIGH value or falls below adjusted ALARM LOW value.
(default:min=35,max=60)
NOTE:
CSI alarm level is always in level II.
NOTE:
Every change in csm large page setting is seen in csm window in normal state.

12.3 CSM Alarm Message and Troubleshooting

Alarm limit is activated as a follow:

Cerebral state index violates ●CSI value blinks.
CSI Alarm Activated
CSM messages on patient monitor include:

Message Cause Solution
●Check all neuro sensors and their
connections.
Placement of neuro sensors and
●Check the patient cable. If not
CSM their connections might be in
connected, then connect it. If faulty,
ELECTROD problem. This alarm can also be
ALARM replace patient cable.
caused by high frequency
●Check if either of the neuro sensors are
instrument.
disconnected or badly connected.
●Replace faulty sensor.
●Check that all neuro sensors and cable
If the impedance of the white or
connections are correctly connected.
black sensors exceeds 1kΩ, the
●Has the use of any mechanical device
SQI will fall gradually. Poor
that could generate high frequency
impedance conditions may cause
activity (e.g. patient warmer) been
the SQI to fall to 50%.
initiated or is any such device in close
Artefacts can have many causes:
CSM SQI LOW proximity to the CSM neuro sensors?
high frequency instrument, EMG,
If possible move disturbing device away
etc. are typical causes.
from the neuro sensors.
If SQI falls because of extensive
●Check grounding of disturbing device.
use of high frequency instrument,
●Reduce the influence from disturbing
it will rise as soon as the high
device by disconnecting CSM Power to
frequency instrument is stopped
let the CSM module run from the battery.
●Check that neuro sensors are not dry.
CSM ●Check that the skin has been cleaned
If sensor impedance is > 5kΩ the
IMPEDANCE properly.
HIGH CSI, BS and EMG will be blanked
●Clean and prepare skin as described in
this manual and attach new neuro sensors.
CSM module is off or it is on but
Try to establish wireless communication.
CSM LINK OFF wireless communication is not
Refer to section 12-2-2
established.
All alarm level for these messages is always in level 3.
Pressing ALARM SILENCE, alarm will be disabled and ignored this fault.

There is some error message that displayed just in csm module as follow:
Turn the csm module off and then on, if the
Error codes
Hardware error problem exist contact after sale service of
(1-10 and 14) manufacturer.
1. Turn off the csm module
If patient cable or the electrodes
2. Disconnect patient cable.
Error codes are connected while the csm
3. Turn on the csm module.
(11,12 and 13) module is performing the start up
4. When the start up check has finished connect
check.
the patient cable for normal operation.
Troubleshooting
● CSM module does not turn on when power key is pressed?
- Change to a new battery or a fully recharged battery.
- If changing the battery does not help, contact after sale service of manufacturer.
● CSI is higher than expected

- Check anesthetic delivery systems: IV lines and status of vaporizers.
- Some patients require a higher dose of drugs due to interpatient variability.
- Adequate dosing for maintenance may not be sufficient for increased stimulation.
● CSI rises along with EMG

High levels of facial muscular or electromyographic (EMG) activity can elevate the CSI
under certain circumstances. When this happens, attention must be paid to the stimuli
received by the patient during surgery. When the patient is asleep, EMG activity can
increase due to reflex reactions to painful stimuli during surgery, lack of muscular
relaxation or muscular rigidity caused by some opioids (analgesics). In the presence of
hypnotically unrelated EMG, administration of a neuromuscular blocking agent may
cause the CSI to decrease.
NOTE:
Facial muscles recover sooner than skeletal muscles. When these artifacts are
present, the CSI should be interpreted with caution.
● LINK indicator on CSM link does not turn on

- Check that this correct CSM link is chosen on the CSM module.
- If CSM module cannot find the monitor with wireless CSM card. Relocate the monitor
to obtain better signal quality, Turn on RF communication in the CSM module.

12.4 CSM module cleaning and maintenance

Cleaning
Clean csm module, csm patient cable and other csm accessory periodically by wiping the outer
case with a lint-free cloth lightly moistened with warm water and a mild, non-abrasive cleaning
solution or 70% isopropyl alcohol.
NOTE:
The csm module is resistant to the following cleaning solutions
● Warm water
● Isopropyl alcohol 99%
● Acetone 10%
● Hydrogen peroxide 3%
Warning
Do not allow fluids to spill or drip on the csm module.
Storage
If the monitor is to be stored for a longer period, it should first be cleaned and the battery
removed. Store in a clean, dry atmosphere at room temperature and, if available, use the original
packaging for protection.
Warning
No user- replaceable fuses in the monitor or csm power.
Warning
The csm module should be disposed of taking into consideration environmental factors,
local laws and regulations. All components can be safely disposed of in the approved
manner as per hospital or locally regulated guidelines. Remove battery, If any, before
disposal.
Maintenance
To ensure the monitor remains in good operating condition, it is important to keep it clean and
carry out the routine maintenance procedures. There are no serviceable parts in this instrument
and all service is to be carried out by the manufacturer.
NOTE:
If the monitor is dropped, damaged or subjected to excessive moisture or high
temperature, immediately be taken out of service for examination by qualified
service personnel.
NOTE:
As required Clean the external surfaces of the monitor thoroughly before and after
a prolonged period of storage
NOTE:
Every 12 months, inspect power adapter plug and cable for damage and also
perform electrical safety check. (Including leakage current measurement)
NOTE:
Disconnect from battery power when performing maintenance.
NOTE:
Should an instrument be dropped or severely shaken, it should immediately be
taken out of service and inspected by qualified service personnel to ensure its proper
function prior to use.

13 ST Monitoring
13.1 GENERAL
ST segment deviation is defined as the displacement above or below the isoelectric level. The
measurement of deviation compares the isoelectric point to the ST measurement point.
The isoelectric point defines the point of zero voltage (no electrical activity) with a default
position of 80ms from R wave as 0msec in the horizontal (time) axis. The ST point occurs in the
ST segment between J-point and the T wave, at a default position of 110 ms after R wave. The
following figure illustrates a typical QRS complex.
Figure 13-1 ST Measurement Algorithm
The ST measurement for each beat complex is vertical difference between the two measurement
points, ST and ISO.
The ST analysis examines QRS complexes classified as normal beats (beat detection and
classification information provided by the arrhythmia algorithm are used to eliminate beat that
are ventricular in origin). The monitor combines the measurements and features of normal beats
into a composite (or average) QRS complex. It derives the ST segment deviation from this
average.
The ST segment algorithm documents changes in ST segment in adult patients that can be
indicative of the severity and duration of myocardial ischemia. Since many ischemic episodes
are silent or painless, countinuous monitoring of ST segment changes can provide the earliest
warning of ischemic events.
NOTE:
ST monitoring is available for adult and pediatric patient and it is not
recommended for neonates.

NOTE:
If there are not at least 5 normal complexes in the last 50 beats of ECG signal, the
ST value will not be displayed.
ST monitoring function is “OFF” as a default. You can switch it “ON”, when this monitoring is
necessary.
When ST monitoring is enabled, current ST values are trended and can be reviewed on the
TREND window.
NOTE:
Measurement unit of ST segment is “mV”.
Figure 13-2 ST value in ECG parameters area
Measurement range of ST segment is between -2.0mV to +2.0mV.
Measurement symbol of ST segment “+” means elevating and “-“means depressing.

13.2 ST ANALYSIS WINDOW

Pick "ST ANALYSIS “in the ECG WINDOW to call up the following menu:
Figure 13-3 ST ANALYSIS WINDOW
■ ST ANALYSIS
Pick this item to enable or disable ST monitoring. The default is OFF. When the ST
monitoring is disabled “ST OFF” is displayed in ECG parameter area.
■ ST ALARM
Indicator.Pick "OFF" to disable the alarm functions and there will be a " " symbol
■ ALARM LEVEL
■ ST LIMIT
ST alarm is activated when the ST segment value exceeds adjusted ALARM HIGH value
or falls below adjusted ALARM LOW value. (Range: -2 ~ +2 step 0.1)
Default for upper limit is +0.2 and for lower limit is -0.2.
■ EVENT DURATION
Pick this item to determine the time that a potential ST alarm condition must persist on
ECG waveform before the monitor classifies it as a valid alarm condition.
Available options for EVENT DURATION are OFF, 15s, 30s, 45s and 60s.The default is
OFF and alarm will be activated immediately if alarm condition happens.

■ ST REALERN
Pick to start a learning procedure. The “RELEARN” message is displayed in the ECG
waveform area of the screen. It takes usually about 20 seconds
During relearn procedure the following action will be done:

- Blanks average stored dominant QRS complex currently displayed on the DEFAULT
POINT Window.
- Learns and identifies the new dominant QRS complex template.
- New complex is displayed on DEFAULT POINT Window.
NOTE:
You can do relearn procedure by selecting <ARR RELEARN> in ECG/ARR
ANALYSIS window.
NOTE:
The monitor automatically begins to learn a reference template whenever you
execute any of the following tasks (If ST ANALYSIS is ON and there is no technical
ECG alarm active, like CHECK LEAD):
- Turning on the monitor
- Connecting ECG cable.
- Changing an ECG lead configuration.
- Choosing “NEW” in HOME / PATIENT INFORMATION
NOTE:
A yellow vertical marker with “LRN” label On ST in TREND window shows the
time in which the learning procedure has been done.
■ DEFAULT POINT
Pick "DEFAULT POINT" in the ST ANALYSIS WINDOW to adjust the position of
both ISO and ST measurement points. When you change the ST and ISO measuring point
on the DEFAULT POINT Window, the monitor recomputes the ST deviation value
accordingly.
Figure 13-4 ECG/ST ANALYSIS/DEFAULT WINDOW

As shown above, the DEFAULT WINDOW shows the dominant QRS complex template. Two
vertical lines indicate the positions of the ISO and ST points.

ISO: It is the base point, used to indicate the baseline point of the ST analysis. The
default is 80ms.
ST: It is the ST measurement point. The default is 110ms.
(Selectable between 5 to 400 ms by step of 5ms)
The reference point is the position where the peak of R-wave locates.
NOTE:
It is good clinical practice to check the position of ISO and ST measuring points
before starting ST monitoring and finishing learning procedure.
NOTE:
In practice, the accurate determination of ISO and ST measuring points requires
careful clinical evaluation.
NOTE:
The ST measurement point should be adjusted if patient’s HR or ECG morphology
changes significantly.
If the template is not established, a horizontal line will display. And if the ST ANALYSIS is
“OFF”, the message “ST ANALYSIS KEY IS OFF” appears in this window.
You may select ISO or ST, and then switch the knob left or right to move the cursor line. When
the cursor is at the required position, you may select the base point or the measurement point.
NOTE:
Abnormal QRS complex is not considered in ST segment analysis.
NOTE:
If pace is on (for patient with pacemaker) or while learning procedure, there is no
waveform in DEFAULT POINT Window and you can see just ISO and ST line, In
this condition, ST value will not be measured.
NOTE:
A red vertical marker with “CHG” label On ST in TREND window shows the time
in which the measuring point has been changed.
13.3 ST Alarm Message

Alarm limit is activated as a follow:
ST segment value violates ●ST value blinks.
ST Alarm Activated
ST messages on patient monitor include:
The ST algorithm has calculated ●Check the isoelectric and ST measuring points.
ST OUT OF
value +1mV outside the high end
RANGE HIGH ●Observe the patient and treat if clinically indicated.
of the ST measurement range.
The ST algorithm has calculated ●Check the isoelectric and ST measuring points.
ST OUT OF
value -1mV outside the low end of
RANGE LOW ●Observe the patient and treat if clinically indicated.
the ST measurement range.
All alarm level for these messages is set in ST WINDOW. Pressing alarm silence, alarm is
suspended for at least 120S.

14 Arrhythmia Monitoring
14.1 GENERAL
Arrhythmia means any disturbance or irregularity of cardiac rhythm. Stability of the cardiac
rhythm is essential for sufficient pumping function of the heart and adequate cardiac output.
Maintaining adequate cardiac output is vital for organ perfusion and survival. Arrhythmia can
cause a decrease in cardiac output. Therefore fast and accurate detection of arrhythmia is critical.
The medical professionals can use the arrhythmia analysis to evaluate patient’s condition (such
as heart rate, PVCs frequency, rhythm and ectopic beat) and give proper treatment.
NOTE:
If arrhythmia monitoring is “ON”, the heart rate is calculated by the arrhythmia
software.
NOTE:
This monitor can detect up to 12 types of arrhythmia.
NOTE:
Arrhythmia monitoring is available for adult and pediatric patient and it is not
recommended for neonates.
Warning
The ARR monitor can only be operated by personnel who have passed professional
training and are familiar with this manual.
Warning
The ARR monitor is intended for use only as an adjunct in patient assessment .It must be
NOTE:
It is recommended to use ECG lead I or II to have the best accuracy of ARR
software.
Arrhythmia detection algorithm principle
The arrhythmia algorithm is based on template matching. (A template is a group of beats
matching the same morphology.)The algorithm detects QRS complexes, generates QRS
templates and performs beat labelling. This algorithm is divided into three parts: detector,
classifier and labelling.
The detector algorithm detects waves in ECG signal that could be QRS complexes.
The classifier algorithm forms templates of similar QRS complexes. During the learning phase
an initial set of QRS template is built. Then the monitor creates a reference template based on its
identification of the patient’s dominant QRS pattern. When a new true QRS complex is detected,
it is compared with the existing templates. If no match is found, a new QRS template is added to
the template set.
The labelling algorithm analyses all templates. Each template and the beats belonging to it are
labelled with one of the following names: normal beats, ventricular beats and questionable beats.
Through this process, the monitor can verify an arrhythmia event’s occurrence.
Parallel to this process there is an algorithm for detection of ventricular fibrillation. Detection of
ventricular fibrillation is based on waveform analysis.

Beat and rhythm classification

Beat classification refers to the analysis of individual beats. If the new beat’s features do not
match those of the normal template, the new beat is classified as premature or questionable.
The monitor uses all detected beats to calculate the heart rate, eliminating questionable beats
from arrhythmia classification.
Rhythm classification refers to analysis of sequences of beats. The monitor compares the
sequence of the last twelve beats with the sequences stored in the monitor’s memory. If it detects
two or more events simultaneously, the monitor alarms in order of event priority.
The following table describes available beat classifications:
Arrhythmia Event and Beat Classification

ECG ASYSTOLE 5 seconds pass without the detection of valid QRS complex.
Ventricular Fibrillation: The monitor identifies a sinusoidal
waveform with fibrillation characteristics. (Certain ventricular
VFIB ARRHYTHMIA tachycardias have sinusoidal waveforms closely resembling those
of ventricular fibrillation. Because of the similarity of these
waveforms, the monitor may classify such types of ventricular
tachycardia as ventricular fibrillation.)
Ventricular Tachycardia: N or more PVC’s are detected in a time
VTAC ARRHYTHMIA interval T= (60*(N-1))/R, where N is defined as the VTAC count
and R is defined as the VTAC rate.
RUN ARRHYTHMIA Ventricular Run: Series of 3 to N-1 consecutive PVCs with a beat
to beat rate ≥ the VTAC rate.
AIVR ARRHYTHMIA Accelerated Idioventricular Rhythm: Series of 3 or more PVCs
with a beat to beat rate less than the VTAC rate.
BIGEMINY ARRHYTHMIA Ventricular Bigeminy: Sequence of beats with the pattern :
normal, PVC, normal, PVC, normal, PVC
TRIGEMINYARRHYTHMIA Ventricular Trigeminy: Sequence of beats with the pattern :
normal, normal, PVC, normal, normal, PVC
COUPLET ARRHYTHMIA Ventricular Couplet: Sequence of beats with the pattern :
normal, PVC, PVC, normal, PVC, PVC
TACHY ARRHYTHMIA Sinus Tachycardia: HR ≥ TACHY rate setting. A PVC or other
abnormal beat breaks the analysis sequence and restarts analysis.
BRADY ARRHYTHMIA Sinus Bradycardia: HR≤ BRADY rate setting. A PVC or other
abnormal beat breaks the analysis sequence and restarts analysis.
PAUS ARRHYTHMIA Actual R-R interval more than 2.1 times of the average R-R
interval.
FREQUENT PVCs More than N (event count set in the ARR SETUP WINDOW)
PVC per minute.

Premature Ventricular Contraction (PVC) is ectopic impulse originating from ventricles, before
the normal electrical activation sequence of the heart has occurred.
The PVC value is shown in ECG parameter window and updated every 5 seconds.
When ARR analysis is enabled, current PVC values are trended every 20 second and can be
reviewed on the TREND window.
Figure 14-1 PVC value in ECG parameters area

NOTE:
When PACE is turned ON, for patient with pacemaker, the system will not detect
the arrhythmia relating to premature ventricular beats. (Including PVCs counting)
14.2 ARR ANALYSIS WINDOW

Pick "ARR ANALYSIS“in the ECG WINDOW to call up the following menu:
Figure 14-2 ECG/ARR ANALYSIS WINDOW
■ ARR MONITOR
Pick this item to enable or disable arrhythmia monitoring. The default is “OFF”. When
the Arrhythmia monitoring is disabled “PVCs OFF” is displayed in ECG parameters
area.

■ ARR SETUP
Pick “ARR SETUP” in ARR ANALYSIS Window to call up the following menu:
Figure 14-3 ECG/ARR ANALYSIS /ARR SETUP WINDOW
The ARR SETUP table allows you to configure arrhythmia monitoring accordingly to your
patient’s needs. All detectable arrhythmia events listed in the first column of the table .Using the
remaining columns, you can modify the attributes of each event. Fields that are not applicable for
certain event category are shown with dash symbol, while those that cannot be modified are
ghosted.
Modifying arrhythmia settings:

1. Scroll the cursor frame to parameters whose arrhythmia functions you wish to configure and
click.
2. Scroll to the function you wish to modify. (The first column, “ALARM LEVEL “, is
highlighted when you first click on a parameter.)
3. Click to access settings of the selected arrhythmia function.
4. Dial through settings and click to confirm your selection.
5. Repeat step 1-4 to configure additional arrhythmia functions or parameters.
● ALARM LEVEL
Available options are 1,2 and OFF to set the grade of alarm for every arrhythmia event.
(For more detail about alarm levels refer to chapter 3.)
Pick "OFF" to disable the alarm functions of selected arrhythmia.
ALARM LEVEL for “ASYSTOLE” cannot be modified and always is in level 1.

● RATE
With count, you can determine the point at which an event call is triggered.
You can’t modify the rate for “ASYSTOLE”, ”VFIB”, ”COUPLET”, ”BIGEMINY”,
”TRIGEMINY”, “PAUS” and “FREQUENT PVCs” .
“RUN” and “AIVR” derive their settings from “VTAC” and cannot be modified .They
are included to quantify their derivation, based on current “VTAC” values.
VTAC: Selectable between 100 and 200 by step of 10.
RUN: Same as VTAC rate
AIVR: ≤ VTAC rate-1
TACHY: Selectable between 100 and 200 by step of 10.
BRADY: Selectable between 30 and 105 by step of 5.
● COUNT
With rate, you can determine the point at which an event call is triggered.
You can’t modify the count for “ASYSTOLE”, ”VFIB”, ”COUPLET”, ”BIGEMINY”,
”TRIGEMINY”,”TACHY”,”BRADY” and “PAUS”.
VTAC: Selectable between 5 and 12 by step of 1.
RUN: Selectable between 3 and VTACcount-1 by step of 1.
AIVR: Count≥3
FREQUENT PVCs: Selectable between 1 and 15 by step of 1.
● ARCHIVE
You can determine whether the selected event is stored, recorded automatically or both.
You can view stored events on ARR EVENT RECALL Window.
STR: Stores selected arrhythmia event.
REC: Automatically generates a recording of selected event.
STR/REC: Event stored and recorded.(even when event alarm is turned off)
OFF: No action if arrhythmia event activates.
● ALL ALARM LEVEL

Press to set the level of all arrhythmia alarms to the same value.
● ALL ARCHIVE
Press to set all arrhythmia ARCHIVE condition to the same state.

■ ARR EVENT RECALL

Pick " ARR EVENT RECALL” in ARR ANALYSIS WINDOW to call up the following
menu:
Figure 14-4 ECG/ARR ANALYSIS /ARR EVENT RECALL
You can review any stored arrhythmia event (maximum 80 events) in this menu.
■ To review different event pages:
Maximum of 8 arrhythmia events can be displayed in the window simultaneously. When there is
more than 8 events, different pages are available. Pick the most left item to review different
pages.
■ To select an arrhythmia event:

Pick the second left item to select an arrhythmia event displayed in the window.
■ To delete an arrhythmia event:

Pick the forth left item to choose an arrhythmia event for removing from list. When you use this
item the selected event will be highlighted, and removed if you exit the window.
NOTE:
To ignore deleting a selected item, click on the “DEL/UNDEL” key one more time
before exiting from this window.

■ To see detail information of arrhythmia event:

Pick the third left item to call up the following window:
Figure 14-5 ECG/ARR ANALYSIS /ARR EVENT RECALL/WAVE WINDOW
In this window, waveform and time of selected arrhythmia event are displayed as well as the
parameter values at the event time.
● UP-DOWN
This option allows you to page up and down to review the waveform and the
parameters of other arrhythmia events.

■ ARR RELEARN
Pick to start a learning procedure. The “RELEARN” message is displayed in the ECG
waveform area of the screen.
NOTE:
You can do relearn procedure by selecting <ST RELEARN> in ECG/ST
ANALYSIS window.
NOTE:
In most situations the learning phase takes about 20 second.
NOTE:
If the monitor couldn’t find 6 matching beats after 20 seconds, the relearn
procedure is continuing and the “RELEARN” message is remaining on display, till
acceptable condition is happened.
NOTE:
While the monitor is in learning phase, all arrhythmia alarms and trend collection
are suspended.
NOTE:
Before starting learning procedure, verify the quality of the ECG signal and ensure
that the patient’s ECG displays a normal reference pattern.
NOTE:
The monitor automatically begins to learn a reference template whenever you
execute any of the following tasks (If ARR ANALYSIS is ON and there is no
technical ECG alarm active, like CHECK LEAD):
- Turning on the monitor
- Connecting ECG cable.
- Changing an ECG lead configuration.
- Choosing “NEW” in HOME / PATIENT INFORMATION
NOTE:
It is recommended to perform relearn procedure under the following conditions:
- A lead is reconnected or electrodes are repositioned.
- Eight hours have passed since last reference complex learned.
- Other significant changes appear on the morphology of the patient’s ECG.

Chapter 15 RECORDING
15.1 General
The bedside monitor has an option of thermal dot matrix recorder. SAADAT modules can be
installed on vital sign monitor optionally.
Performance of the Recorder
■ Recorder sweep is selectable between 12.5, 25 and 50 mm/s.
■ Up to 2 selectable waveforms recording.
■ The real time and freeze recording.
■ The selectable automatic time interval recording.
■ The selectable automatic alarm recording.
15.2 Recording type

Monitor provides several recording types:
■ Continuous real-time recording.
■ 10, 20 and 30 seconds real-time recording.
■ 10 seconds automatic recording.
■ Parameters alarm recording.
■ Arrhythmia alarm recording.
■ Frozen waveform recording.
■ Parametric recording.
■ TREND recording.
■ NIBP LIST recording.
■ ARR EVENT LIST recording.
■ ARR WAVE recording.
Manual Recording
Continuous real-time recording starts from last 5 seconds when you press the “Rec/Stop” key
and stops when you press it again.
10, 20 and 30 s Recording

Real time recording starts from last 5 seconds when you press “Rec/Stop” and it will
automatically stop after 10, 20 or 30 seconds depending on your setting.
Automatic Recording
The monitor starts the recording for 10 seconds according to interval time set in the "PERIODIC
INTERVAL" of the "RECORDER WINDOW" menu. Refer to 2.6 Recorder for details.
Alarm Recording
If “ALARM REC” is set”ON” in each parameter’s window, the system automatically starts
recording when an alarm occurs. Alarm recording is activated when the numeric parameters
violate adjusted alarm limits or when an arrhythmia event occurs.
When an alarm of parameters has occurred only numeric parameters will be recorded and
parameter’s value that triggered the alarm record, marked with an arrow.
During HR alarm recording, the monitor also records 20 seconds ECG waveform.
You can ” ON” or ” OFF” alarm recording in HOME /RECORDERWINDOW and also it can be
set in each parameters menu.(When the system has internal recorder option and it is enabled)

Freeze Waveform Recording

The monitor prints out 20 seconds of the selected waveforms and numeric parameters in
FROZEN mode. So you can freeze the abnormal waveforms on the screen and record it.
Parametric Recording
Parametric recording starts when you press “Rec/Stop” key if both trace in RECORDER
WINDOW set to “OFF”.
TREND Recording
The monitor can print out the trend graph and numeric parameters in the current TREND
WINDOW. Pick "RECORD" in TREND WINDOW to start recording.
NIBP LIST Recording
The monitor can print out entire of the list in NIBP LIST WINDOW. Pick "RECORD" in NIBP
LIST WINDOW to start recording.
ARR EVENT LIST Recording
The monitor can print out entire of the list in ARR EVENT LIST WINDOW. Pick "RECORD"
in ARR EVENT LIST WINDOW to start recording.
ARR WAVEFORM Recording

The monitor can print out stored arrhythmia waveforms in ARR EVENT RECAL/WAVE
WINDOW. Pick "RECORD" in this window to start recording.
15.3 Recorder operations and status messages

Notes on Recording
■ Recording Type:
MANUAL RECORD
PERIODIC RECORD
ALARM RECORD (name of the alarm parameter)
FREEZE RECORD
(Parameter) TREND RECORD
NIBP LIST RECORD
ARR EVENT LIST RECORD
ARR WAVEFORM RECORD
■ Recording Date and Time
■ Bed number
■ Patient name, Patient ID, Gender, Height, Weight, Date of birth
■ Parameter name and value
■ Sweep Speed
■ ECG lead, filter and gain or RESP lead on the waveform
■ Hospital and ward name
■ Dr Name
15.4 Recorder paper

You should use 58mm paper for SAADAT recorder.
NOTE:
Use only manufacturer recommended white thermosensitive record paper,
otherwise the recording quality may be poor and the thermosensitive printhead may
be damaged.

NOTE:
Do not use grid paper.
NOTE:
Do not use paper with edges that are pasted or have turnups at the start of the roll.
If they need to be used unavoidably, replace with new paper roll as soon as possible
before entire roll is used up.
Warning
Do not touch the recorder head while recording and immediately after recording because it
is so hot and may lead to personal injury including burns.
Warning
While the recorder is working, the record paper goes out steadily. By pulling the paper, the
recorder will be damaged.
Loading the paper:

■ Pull down the switch on the recorder case.
■ Insert a new roll of paper into the paper cassette. Printing side of the paper should
face the thermo sensitive printhead.
■ Close the recorder door.
NOTE:
Thermo sensitive surface of paper should be placed facing the head. Be sure to place
the paper correctly.
a. incorrect placement b. correct placement

Figure 15-1 recorder paper placement
NOTE:
The paper detector may not operate properly if covered with foreign matter.
Therefore, if you find foreign matter on the sensor, remove it and clean the sensor.
NOTE:
If the paper is jammed, open the recorder door and remove the paper. Do not pull
the paper by force.
NOTE:
Be careful when inserting paper. Avoid damaging the thermosensitive printhead. Do
not touch thermosensitive print head.

NOTE:
It is recommended to use the paper with coloured marks intended to aware that the
paper is near to finish. Otherwise, the operator should be sure about sufficient
paper for recording.
15.5 Recorder status message

Turning the system off and then on if problem exist
Rec. Software Error Software error
again contact to after sales service of manufacturer.
Recorder Fault Hardware error
Door Open The recorder door is open Close the recorder door.
Out of Paper Record paper finished. Insert recorder paper.
Print head High Temp The thermal head is too hot. Stop operation for some minutes.

Print head High Vol. Print head voltage is high.
Print head Low Vol. Print head voltage is low.
Time out Error The recorder could not record.
15.6 Recorder cleaning

When foreign matter adheres between the thermal head and platen roller, it may cause print
failure. If accumulation of paper powder or foreign matter is seen, or print quality seems to have
deteriorated, clean the thermal head and platen roller.
Clean the head elements and platen roller surface using alcohol and a cotton swab. Wait until the
alcohol dries then close the recorder door.
Warning
Do not clean the printer immediately after printing because thermal head and its periphery
are hot during and after printing.
NOTE:
Do not use sandpaper, cutter knifes etc. when cleaning. They will damage the heat
element.

Chapter 16 Patient Safety

The Patient Monitor is designed to comply with the international safety standard requirements
for medical electrical equipment. This device has floating inputs and is protected against the
effects of defibrillation and ESU. If the correct electrodes are used and applied in accordance
with the manufacturer instructions, the screen display will recover within 10 seconds after
defibrillation.
This symbol indicates that the monitor has CF type and Defibrillation Proof applied part
according to IEC-601-1. The modules with this symbol contain an F- Type isolated (floating)
patient applied part providing a high degree of protection against shock, and is usable during
defibrillation.
This symbol indicates that the monitor has BF type and Defibrillation Proof applied part
according to IEC-601-1. The modules with this symbol contain an F- Type isolated (floating)
patient applied part which contains a high degree of protection against shock, and is usable
during defibrillation
Note:
Type BF applied parts are not suitable for direct cardiac application.
Warning
Do not touch the patient, bed or instrument during defibrillation.
Follow the instructions below to ensure a completely safe electrical installation.
The environment where the Portable Patient Monitor will be used should be reasonably free from
vibration, dust, corrosive or explosive gases, extremes of temperature, humidity and so on.
The Patient Monitor operates within specifications at ambient temperatures between 0ºC and
40ºC. Ambient temperatures that exceed these limits could affect the accuracy of the monitor and
cause damage to the modules and circuits.
Grounding the patient monitor

To protect the patient and hospital personnel, the case of patient monitor must be grounded. The
patient monitor is equipped with a detachable 3-wire cable which grounds the instrument to the
power line ground (protective earth) when plugged into an appropriate 3-wire receptacle .If a 3-
wire receptacle is not available, consult the hospital electricians. If there is any doubt regarding
the completeness of the protective grounding wire, the equipment must be operated with internal
battery or DC input.

Equipotential Grounding
Protection class I instruments are already included in the protective grounding (protective earth)
system of the room by way of grounding contacts in the power plug. For internal examinations
on the heart or the brain, the portable Patient Monitor must have a separate connection to the
equipotential grounding system. One end of the equipotential grounding cable (potential
equalization conductor) is connected to the equipotential grounding terminal on the rear panel of
the monitor and the other end to one point of the equipotential grounding system.
The equipotential grounding system is for the safety function of the protective grounding
conductor if ever there is a break in the protective grounding system. Examinations in or on the
heart (or brain) should only be carried out in medically used rooms incorporating an
equipotential grounding system. Check each time before use that the instrument is in perfect
working order.
Warning
Possible explosion hazard if used in the presence of flammable anesthetics.
Explanation of Symbols in the Monitor
This symbol means "BE CAREFUL". Refer to the manual
Equipotential grounding system.

Chapter 17 CARE AND CLEANING

17.1 System Check
Before using the monitor, do the following:
■ Check if there is any mechanical damage on the system and accessories.
■ Check if all the power cable and accessories are firmly connected.
■ Check if all the functions of keyboard and modules to make sure that the monitor is in proper
condition.
If you find any damage on the monitor, stop using the monitor on patient, and contact the
biomedical engineer of the hospital or local After Sale Service.
The overall check of the monitor, including the safety check, should be performed only by
qualified personnel.
All the checks that need to open the monitor and the safety check and maintenance should be
performed by After Sales Service.
Note:
It is recommended to calibrate the system by manufacturer every 2 years. The IBP
and capnography modules should be calibrated every 6 month.
Warning
If users do not follow a satisfactory maintenance schedule, the monitor may become
invalid, and human health may be endangered.
Note:
To ensure maximum battery life, it is recommended that, at least once a month, the
monitor be run on battery until it turns itself off and then recharged. (For details
about battery care see 1.5)
17.2 Cleaning
Warning
Before cleaning the monitor or the sensor, make sure that the equipment is switched off
and disconnected from the power line.
The Patient Monitor must be kept dust-free.

Regular cleaning of the monitor shell and the screen is strongly recommended. Use detergents
such as soap and water to clean the monitor shell.
Note Please pay special attention to the following items:

1. Most cleaning agents must be diluted before use. Follow the manufacturer's direction
carefully to avoid damaging the monitor.
2. Don't use rough material, such as steel wool etc.
3. Don't let the cleaning agent enter into the chassis of the system.
4. Don't leave the cleaning agents on any part of the equipment.

The monitor and sensor surface can be cleaned with hospital-grade ethanol and dried in air or
with a clean cloth.
17.3 Sterilization
To avoid extended damage to the equipment, sterilization is only recommended when stipulated
as necessary in the Hospital Maintenance Schedule.
Recommended sterilization material: Activated dialdehyde (Cidex)
Caution
■ Do not let liquid enter the monitor.
■ No part of the monitor can be subjected to immersion in liquid.
■ Do not pour liquid onto the monitor during sterilization.
■ Use a moistened cloth to wipe up any agent remaining on the monitor.
17.4 Disinfection
Examples of disinfectants that can be used for the case of monitor are listed below:
■ Hydrogen Peroxide 3%
■ Alcohol 70%
■ Isopropanol
■ Enpropanol
To avoid extended damage to the equipment, disinfection is only recommended when stipulated
as necessary in the Hospital Maintenance Schedule.
Caution
Do not use EtO gas to disinfect the monitor.
NOTE:
Manufacturer has no responsibility for the effectiveness of controlling infectious
disease using these chemical agents. Please contact infectious disease experts in your
hospital for details.
NOTE:
Do cleaning, sterilization and disinfection of slave monitor same as the bed side
monitor.
Appropriate cleaning, sterilization and disinfection materials for accessories are introduced in
each module's chapters.

Chapter 18 Getting Started

18.1 Open the Package and Check
Open the package and take out the monitor and accessories carefully. Keep the package for
possible future transportation or storage.
■ Check for any mechanical damage.

■ Check for the existence of the power cable and accessories.
If there is any problem, contact the distributor immediately.
18.2 Place the battery fuse

When you use the system for the fist time, you should place the fuse on the rear panel.
18.3 Connect the Power Cables

Connection procedure of the AC power line:
■ Make sure the AC power supply complies with following specification: 200-240 VAC,
50 /60Hz
■ Apply the power cable provided with the monitor. Plug the power cable to power supply
socket of the monitor. Connect the other end of the power cable to a grounded 3-wire power
receptacle.
NOTE:
Make sure that the battery indicator lights. If it does not light, check your local
power supply and power cable connection. If the problem still exists, contact the
local After Sale Service.
NOTE:
The battery needs to be charged after transportation or storage. If the power supply
is not properly connected before turning on the monitor, it may not work properly
because of insufficient power. Connect the power supply to charge the battery for
about 24 hours.
18.4 Power on the Monitor

Press POWER to power on the monitor. At the same time a beep will be heard and yellow and
red indicator light about 2.5 seconds separately. After 30 seconds or so, the system will display
the monitoring screen after self-test, and you can perform normal monitoring now.
NOTE:
Check all the functions of modules that may be used and make sure that the monitor
is in good connection.

NOTE:
The battery must be recharged after each use to ensure adequate electricity reserve.
To do so, you only connect the system to AC INPUT.
Warning
If any sign of damage is detected, or the monitor displays any error messages, do not use it
on any patient. Contact biomedical engineer in the hospital or local After Sale Service
immediately.
18.5 Connect Patient Sensors

Connect all the necessary accessories between the monitor and the patient.
NOTE:
For information on correct connection, refer to each module's chapters

Chapter 19 Technical specifications
CLASSIFICATION
Protection against electroshock Class I, Type CF for all modules (except Multi-gas module
that is BF) (based on IEC 60601-1)
Mode of operation Continues operation equipment
Harmful Liquid Proof Degree Ordinary equipment, (without Liquid Proof)
Method of sterilization and disinfection Refer to each module's chapters and chapter 17 for detail.
Safety of anesthetic mixture Not suitable for use in the presence of a flammable
anaesthetic mixture with air or with oxygen or nitrous
oxide.
DISPLAY
VIZOR10 Display TFT COLOR 800 × 600, 10.4”

VIZOR12 Display TFT COLOR 800 × 600, 12”
Waveforms ECG, SPO2, IBP1, IBP2, RESP/GAS,EEG (Freezable)
Numeric Parameters HR,PVCs,ST,SPO2, NIBP (SYS, DIA, MAP),
IBP1(SYS,DIA,MAP), IBP2(SYS,DIA,MAP),
RR, T1, T2, DT, EtCo2, FiCo2,
AWRR,EtN2O,FiN2O,EtO2,FiO2,EtAA,FiAA,
CSI,BS%,EMG%,SQI%
Operation Method Membrane and rotary knob
ECG
Leads Selectable 3 or 5 Wires

For 3 wire: I, II, III
For 5 wire :I,II,III,V,aVR,aVF,aVL
Dynamic Range ± 5 mV
Leakage Current < 10 µA
Lead Off Current < 90 nA
Gain 4, 2, 1, 1/2, 1/4, Auto
Calibration 1mV, 0.5 sec
Filters “MONITOR” ( 0.5 - 28 Hz )
“NORMAL” ( 0.5 - 40 Hz )
“EXTENDED” ( 0.05-100 Hz)
CMRR > 98 dB
Internal Noise < 30 µV RTI
Input Impedance > 5 Mohm
QRS Detection Duration : 40 to 120 msec
Amplitude : 0.25 to 5 mV for Adult
0.2 to 5 mV for Neonate
Heart Rate Range 15 - 300 bpm for adult
15 - 350 bpm for neonate
Accuracy ±1% or 2 bpm
Tall T-Wave Reject up to 1.2 mV Amp.
Pacer Detection/Rejection Duration : 0.1 - 2 msec
Amp: ±2 to ± 700 mV (Without over/undershoot)
Reject From Heart Rate Counter
Re-insert into ECG to display on screen
Protection Defibrillator and Electrosurgery
Standards ANSI/AAMI EC-13

ARRHYTHMIA ANALYSIS
Type ASYS, VFIB, VTAC, RUN, AIVR, COUPLET,
BIGEMINY, TRIGEMINY, TACHY, BRADY, PAUS,
FREQUENT PVCs
Learning Rapid Learning: only 20 Seconds Required for
Recognition of Dominant Rhythm.
Method Real Time Arrhythmia Detection with Innovative Feature.
Memory Capability of storing the latest 80 ARR event. (waveform
and Parameters)
ST ANALYSIS
Display resolution: 0.01 mV

Measurement Range -2mv to +2mv
Alarm Range: -2mv to +2mv
Features: User Adjustable Isoelectric and ST Point Trending of ST
Values
Update period: 5 Sec.
NIBP
Measurement method Oscillometric

Measurement mode Manual/Automatic/Stat
Measurement time 18-26 sec (excluding cuff pressurization time)
Measurement Range Adult: SYS 25 ~ 250 mmHg
DIA 10 ~ 220 mmHg
MAP 15 ~ 250 mmHg
Neonate: SYS 25 ~ 135 mmHg
DIA 10 ~ 110 mmHg
MAP 15 ~ 125 mmHg
Pressure Transducer accuracy ±3 mmHg full range
Initial Inflation Target Adult 150 mmHg, Neonate 70 mmHg
Overall System Efficacy Meet ANSI/AAMI SP-10/1992
Memory 100 Records
SPO2 (Pulse Oximetry)

Method 2 Wave Length Pulse Wave Type
Range 50 to 100 %
Accuracy 2% (SPO2 71 ~ 100%)
3% (SPO2 50 ~ 70%)
Pulse Rate Range 25 - 250 BPM
TEMPERATURE
Probe Type YSI-700/ YSI 400 Compatible
Range 0 - 50 °C
Accuracy ± 0.2 °C

RESPIRATION
Method Impedance
Base Resistance 250 -1250 Ohm
Dynamic Range 0.2 - 2 Ohm
Breath Rate Range 6 - 150 BrPM
Accuracy ±2% or 2 BrPM
IBP
Channel 2
Measurement Range SYS -50 ~ 300 mmHg
DIA -50 ~ 300 mmHg
MAP -50 ~ 300 mmHg
Pressure Filter 8Hz, 16Hz,22Hz selectable
Press Sensor Sensitivity 5 µV / V / mmHg
Press Sensor Impedance 300 ~ 2500 Ohm
Resolution 1 mmHg
Accuracy 2 % or 2mmHg each one is greater
Multi-gas (Mainstream)
Power supply 4.5-5.5 VDC, max 1.4W

Method Infrared absorption
Measuring mode Mainstream
IRMA Harmful Liquid Proof Degree IPX1
Et and Fi Parameters
Fi and ET are displayed after one breath and have a continually updated breath average.
IRMA CO2 :CO2, CO2 waveform
IRMA ICU:CO2,O2, 2 selectable waveform
IRMA OR:CO2,O2,N2O, Anaesthesia Agent(HAL,ISO,ENF,SEV,DES)
5 selectable waveform, MAC
IRMA OR+: CO2,O2,N2O, Anaesthesia Agent(HAL,ISO,ENF,SEV,DES)
5 selectable waveform, Automatic identification, MAC
Sensor head 3-10 channel NDIR type gas analyzer measuring at
4-10µm. pressure, temperature and full spectral
interference correction.
Sensor Dimension (W×D×H) 37×27×25mm
Sensor weight <30g(cable exclude)
Oxygen sensor integrated ultra-fast response time galvanic oxygen sensor.
>62500 oxygen hours
Calibration No routine calibration required
Room air calibration of O2 sensor performed
automatically when changing airway adapter (<5sec)
Warm-up time concentrations reported in less than 10s,
full accuracy with in 1 minute
Surface temperature max 55ºC / 133ºF
Rise time (@10 l/min) CO2≤ 90ms
O2≤300ms
N2O≤300ms
HAL,ISO,SEV,ENF,DES≤300ms
Delay time ≤ 140ms
Primary agent threshold 0.2% V/V
Secondary agent threshold 0.2% +10% of total agent concentration
Agent identification time <20 seconds
Total system response time < 1 second
AWRR measuring range 3~100BrPM

Accuracy specifications-during standard conditions:

Gas measuring range accuracy
CO2 0~10% ±(0.2%ABS+2%REL)
10~20% Unspecified
N2O 0-100% ±(0.2%ABS+2%REL)
HAL,ISO,ENF 0-5% ±(0.15%ABS+5%REL)
5-12% Unspecified
SEV 0-8% ±(0.15%ABS+5%REL)
8-15% Unspecified
DES 0-18% ±(0.15%ABS+7%REL)
18-22% Unspecified
O2 0-10% Unspecified
10-100% ±(1%ABS+2%REL)
Accuracy specification-during all condition
CO2 ±(0.3%ABS or ±4%REL)
N2O ±(2%ABS or ±5%REL)
Single agent ±(0.2%ABS or ±10%REL)
Dual agent ±(0.2%ABS or ±10% of total agent concentration)
O2 ±(2%ABS+2%REL)
Note1 : The accuracy specification is valid for all specified environment conditions, and includes effects from
the following interfering gases : N2O, O2, HAL, ISO, ENF, SEV, DES, Ethanol, Isopropyl alcohol, Acetone,
Methane, He. See Appendix IV for effects from water vapour partial pressure on gas reading.
Note2: The accuracy specification is not valid if more than one gas for IRMA OR and more than two gas for
IRMA OR+/AX+ are in the gas mixture.
Multi-gas (Sidestream)
Power supply 4.5-5.5 VDC

ISA CO2: <1.4 W (normal op.), <1.8 W (peak @ 5 VDC)
ISA AX+: <1.6 W (normal op.), <2.0 W (peak @ 5 VDC)
ISA OR+: <2.0 W (normal op.), <2.4 W (peak @ 5 VDC)
Method Infrared absorption
Measuring mode Sidestream
Et and Fi Parameters Fi and ET are displayed after one breath and have a
continually updated breath average.
ISA CO2 :CO2, CO2 waveform
ISA OR+/AX+:CO2,O2, N2O, primary and secondary
Agent(HAL,ISO,ENF,SEV,DES)
Automatic agent identification ISA OR+/AX+: primary and secondary agent.
Sensor head 2-9 channel NDIR type gas analyzer measuring at
4-10µm.
Sensor Dimension (W×D×H) ISA CO2/AX+: 78×49×33mm
ISA OR+: 47×88×99mm
Sensor weight ISA CO2/AX+: 130g (including cable)
ISA OR+: 400g (including cable)
Calibration No span calibration is required for the IR bench. An

automatic zero reference calibration is performed at
startup and then every 24 hours.
Compensation ISA CO2: Automatic compensation for pressure and
Temperature. Manual compensation for
broadening effects on CO2.
ISA CO2/AX+: Automatic compensation for pressure,
temperature and broadening effects on CO2.
Warm-up time ISA CO2: <10 seconds (concentrations reported and full
accuracy)

ISA OR+/AX+: <20 seconds (concentrations reported,

automatic agent identification enabled and full accuracy)
Operating temperature ISA CO2: 0 to 50°°C
ISAOR+ /AX+: 5 to 50°°C

Storage temperature -40 to 70°°C
Operating humidity <4 kPa H2O (non-condensing)
(95 %RH at 40°°C)
Storage humidity 5 to 100 %RH (condensing)
(100 %RH at 40°°C)
Operating atmospheric pressure 52.5 to 120 kPa
(Corresponding to a max altitude of 4572 m/15000 feet)
Storage atmospheric 20 to 120 kPa
Typical rise time at 50 l/min sample flow CO2 ≤ 200 ms (≤ ≤ 250 ms for ISA OR+/AX+)
N2O ≤ 350ms
Agents ≤ 350ms
O2 ≤ 450ms
Primary agent threshold (ISA OR+/AX+) 0.15 V%. When an agent is identified, concentrations will
be reported even below 0.15 V%
Secondary agent threshold (ISA OR+/AX+) 0.2 V% +10% of total agent concentration
Agent identification time (ISA OR+/AX+) <20 seconds (Typically <10 seconds)
Total system response time < 3 second (with 2m sampling line)
Sampling flow rate 50 ± 10 ml/min
Respiration rate 0~150BrPM
Accuracy specifications-during standard conditions:
Gas measuring range accuracy
CO2 0~15% ±(0.2 V% +2% of reading)
15~25% Unspecified
N2O 0-100% ±(0.2 V% +2% of reading)
HAL,ISO,ENF 0-8% ±(0.15 V%+5% of reading)
8-25% Unspecified
SEV 0-10% ±(0.15 V% +5% of reading)
10-25% Unspecified
DES 0-22% ±(0.15 V% +7% of reading)
22-25% Unspecified
O2 0-100% ±(1 V% +2% of reading)
Accuracy specification-during all condition
CO2 ±(0.3 kPa + 4% of reading)
N2O ±(2 kPa + 5% of reading)
Agents ±(0.2 kPa + 10% of reading)
O2 ±(2 kPa + 2% of reading)
Note1: The accuracy specification is valid for all specified environment conditions.
Note2: The accuracy specification is not valid if more than tow agents are present in the gas mixture. If more
than tow agents are present, an alarm will be set.
CSM
EEG sensitivity ±400µV
Noise <2µVp-p <0.4µV RMS, 1-250 Hz
CMRR >140dB
Input impedance >50Mohm
Sample rate 2000 samples/sec(14 bits equivalent)
CSI and update 0-100. Filter 6-42Hz, 1sec. update
EMG 0-100 logarithmic. Filter 75-85 Hz,1 sec. update
BS% 0-100%. Filter 2-42 Hz, 1 sec. update
Digital output Wireless to CSM card in monitor (ISM 2.4GHz)
Wireless range Up to 10 meters
Display size 1.3" x 0.7"

Alarms High/low with user selectable limit

Artifact rejection Automatic
Sensor impedance range 0-10kOhm I measurement current 0.01µA
Battery Rechargeable NiMH or 9V Alkaline (6AM6/IEC:
6LR61/ANSI: 1604A)
Supply current 30mA(typical)
Max. battery lifetime-Alkaline 30h(stand alone)
18h(transmitting wireless)
Battery recharge time 4 Hours (CSMX04 Only)
Weight 4.6 ounces (130 g) with battery
Dimensions 4.6×2.7×1.2”
Classification Internal power supply Class II, type BF, continuous use
Sensors Danmeter Neuro Sensors
Cable length 77” with 14” split
Mounting options Velcro strip l.7x0.9"
Memory Data recording 18 hours
CSM module Environment - Operation Temperature 50-104°F
Rel humidity 30~75%
Air pressure 700-1060 hPa
CSM module Environment-Transport and storage Temperature 50-104°F *
Rel. humidity 30-95%
Air pressure 700-1060hPa
*If transport without sensors:-4-158°F
RECORDER
Model General Scanning / SAADAT Thermal Printer
Printing Speed 12.5, 25, 50 mm/sec
Paper 50mm(for GSI) / 58mm(for SAADAT) by 100 foot roll
ALARM
Sources Error messages, All other Parameter Limits
Alarm On/Off Selectable for All Parameters
Alert Blinking on Display,
Volume Selectable Audio Alarms
Light indicator
TREND
Sources HR,PVCs,ST,SPO2, NIBP, RR, T1, T2,
IBP1(SYS,DIA,MAP), IBP2(SYS,DIA,MAP),
EtCo2,FiCo2,AWRR(sidestream, mainstream),
EtN20,FiN2O,EtO2,FiO2,EtAA,FiAA(ISO, DES, ENF,
HAL, SEV)
Trend Time 15, 30 Min, 1, 2, 4, 8, 12, 24, 36, 48, 60, 72 Hours
Resolution 20 sec
INPUT/OUTPUT
Network Digital, Serial, RS422, Full Duplex

Connection 8/16 BED to One CENTRAL system
GENERAL
Safety Based on IEC 60601-1, Class I

Protection Against Electro surgery and Defibrillator

AC Power 90 - 260 VAC, 50/60 Hz
Internal Battery Sealed Lead Acid, Rechargeable, 12 V, 3.3 AH
Usage: 80 min (Full Charge)
DC Power Plug 12-14 V, Maximum 3 A (Without Recorder)
Maximum 6 A (With Recorder)
S1600 Dimension 26 (W) × 21 (H) × 18 (D)
Weight 5.5 Kg (approximately)
S1800 Dimension 31 (W) × 28 (H) × 19 (D)
Weight 6 Kg (approximately)
ENVIRONMENTAL
Temperature Operating: 5 to 40 °C
Storage: -20 to 60 °C
For gas module Operating: 10-35 °C
Storage: -20 to 50°°C)
Humidity 20-90 % (Noncondensing)
Altitude -200 to 3000 m

Chapter 21 Trouble shooting

Repairing the internal parts of the monitor must be only done by trained and authorized
personnel of After Sale Service; otherwise manufacturer. will not take any responsibility for
any possible hazard to the patient and the monitor.
Troubleshooting guide is intended to help users to solve minor problems caused by incorrect
use of the monitor or failure of accessories.
When you face any problem, please be sure that you have followed all procedure mentioned
in Correct Action column before you contact with After Sale Service.
Fault Symptoms Possible Cause Correct Action

●Check POWER AC path
Not to be turned on
●Call for service
●Battery is discharged ●Charge the battery for 10 hours
Unable to work with Battery ●Fuse of Battery is faulty ●Check fuse existence
●Others ●Call for service
●Connect ECG cable correctly
●ECG cable is not connected correctly
●Check leads and electrodes.
NO ECG waveform ●Bad placement of leads and electrodes
●Don’t use old and faulty electrodes
●Others
●Call for service
●Loose connection of electrodes ●Check electrodes and leads
●Earth connection failure ●Check earth
Noisy ECG waveform
●Wrong ECG filter ●Set filter mode correctly
●If "PACE ON"for patient without Pace marker
Spike on ECG waveform , ECG noise will be received as PACE. ●Turn “Paced detect” OFF in ECG menu
●Others
●ECG signal is noisy or isn’t suitable
Unstable HR ●Change lead to display the best ECG signal
●Others
●Call for service
No “RESP” signal ●Electrodes are not connected correctly
●change RESP lead
No good waveform ●Patient move during measurement
●Calm patient
Unstable RR ●Others
●Call for service
●Location of sensor isn’t suitable ●Put the sensor in suitable place
Strange T1,T2 ●Faulty sensor ●Change sensor
●SPO2 probe in an unsuitable place. ●Change the place of probe on patient
No SPO2 waveform
●Faulty sensor ●Change probe
Noisy waveform ●Call for service
●Others
●Patient movement during measurement ●Calm patient
Strange SPO2 value ●Probe is in an unsuitable place. ●Change the place of probe
●Incorrect air hose connection. ●Check connection
●Air hose occluded or tangled. ●Check Air hose
NIBP can not inflate
●Air hose or cuff leakage ●Change faulty accessory
●No cuff or Air hose is connected ●Check cuff and air hose
NIBP measurement is not
●Wrong cuff placement ●Change cuff placement
successful
●Patient movement during measurement ●Calm patient
strange NIBP value.
●No zeroing before use ●zeroing
●noisy source exists near by system or ●keep system and cable away from noise
Strange IBP value
accessories source
Noisy IBP signal
●faulty sensor ●change sensor
1 Heyer Medical AG – VizOR 10 / 12 Operator’s Manual Rev. 2.0 – 09/11

APPENDIX I
,
LIST OF MONITOR S PARAMETERS (SELECTIONS AND DEFAULTS)
Menu item Selection Default
The parameters in ECG menu
ECG LEAD I,II,III,V,aVR,aVF,aVL II
ECG GAIN ×0.25,×0.5,×1,×2,×4,AUTO AUTO
ECG SWEEP 12.5,25,50mm/s 25
ALARM LEVEL 1,2 1
HR ALARM ON,OFF OFF
HR HIGH ALARM HR LOW ALARM +5 to 250 150Bpm
HR LOW ALARM 30 to HR HIGH ALARM -5 50Bpm
ECG FILTER MONITOR,NORMAL,EXTENDED NORMAL
HR SOURCE ECG,SPO2,IBP1,IBP2,AUTO AUTO
BEAT VOLUME 1,2,3,4,5,6,7,OFF 2
PACE DETECT ON,OFF OFF
ECG CALIB ON,OFF OFF
ECG AVERAGE 4,8,16SEC 8SEC
LEAD TYPE 3LEAD,5 LEAD 3LEAD
The parameters in RESP menu
RESP LEAD RA-LA,RA-LL RA-LA
RESP GAIN ×0.25,×0.5,×1,×2,×4 ×1
RESP SWEEP 3,6,12.5,25mm/s 12.5mm/s
ALARM LEVEL 1,2 1
RR ALARM ON, OFF OFF
RR HIGH ALARM RR LOW ALARM +1 to 150 25Brpm
RR LOW ALARM 5 to RR HIGH ALARM -1 5Brpm
APNEA LIMIT 10 to 40S, OFF 10S
The parameters in SPO2 menu
SPO2 RESPONSE SLOW, NORMAL,FAST NORMAL
SPO2 PLETH SWEEP 12.5,25mm/s 25mm/s
ALARM LEVEL 1,2 1
SPO2 ALARM ON,OFF OFF
SPO2 HIGH ALARM SPO2 LOW ALARM +1 to 100 100
SPO2 LOW ALARM 20 to SPO2 HIGH ALARM -1 85
SPO2 PULSE RATE ON,OFF OFF
SPO2 SENSITVITY NORMAL, MAX, APOD NORMAL
SPO2 PULSE RATE ON,OFF OFF

The parameters in NIBP menu
NIBP UNIT mmHg, KPa mmHg
ALARM LEVEL 1,2 1
NIBP ALARM ON,OFF OFF
SYS HIGH ALARM SYS LOW ALARM +5 to 240 150 mmHg
SYS LOW ALARM 30 to SYS HIGH ALARM -5 80 mmHg
DIA HIGH ALARM DIA LOW ALARM +5 to 180 120 mmHg
DIA LOW ALARM 20 to DIA HIGH ALARM -5 60 mmHg
MAP HIGH ALARM MAP LOW ALARM +5 to 200 150 mmHg

MAP LOW ALARM 25 to MAP HIGH ALARM -5 80 mmHg
1 min, 2 min,3min,5min,10min,15min,20min
30min,45 min, 60 min, 90 min
AUTO/MANUAL MANUAL
2hr,4hr,6 hr, 8 hr,12 hr, 16 hr 20 hr, 24 hr,
MANUAL,STAT
The parameters in TEMP menu
TEMP UNIT ºC,ºF ºC
ALARM LEVEL 1,2 1
TEMP ALARM ON, OFF OFF
T1 HIGH ALARM T1 LOW ALARM +1 to 50 39
T1 LOW ALARM 0 to T1 HIGH ALARM -1 35
T2 HIGH ALARM T2 LOW ALARM +1 to 50 40
T2 LOW ALARM 0 to T2 HIGH ALARM -1 36
DT HIGH ALARM DT LOW ALARM +1 to 50 50
DT LOW ALARM 0 to DT HIGH ALARM -1 0
The parameters in IBP menu
IBP UNIT mmHg, KPa,cmH2O mmHg
ALARM LEVEL 1,2 1
IBP ALARM ON,OFF OFF
SIS: 150 mmHg
IBP HIGH ALARM IBP LOW ALARM +5 to 300 DIA: 100 mmHg
MEAN: 115 mmHg
SIS: 80 mmHg
IBP LOW ALARM -50 to IBP HIGH ALARM -5 DIA: 50 mmHg
MEAN: 60 mmHg
SIS: 150 mmHg
ART HIGH ALARM ART LOW ALARM + 5 to 300 DIA: 100 mmHg
MEAN: 115 mmHg
SIS: 80 mmHg
ART LOW ALARM -50 to ART HIGH ALARM -5 DIA: 50 mmHg
MEAN: 60 mmHg
SIS: 150 mmHg
LVP HIGH ALARM LVP LOW ALARM +5 to 300 DIA: 20 mmHg
MEAN: 80 mmHg
SIS: 80 mmHg
LVP LOW ALARM -50 to LVP HIGH ALARM -5 DIA: -5 mmHg
MEAN: 20 mmHg
SIS: 40 mmHg
PAP HIGH ALARM PAP LOW ALARM +1 to 120 DIA: 20 mmHg
MEAN: 30 mmHg
SIS: 5 mmHg
PAP LOW ALARM -50 to PAP HIGH ALARM -1 DIA: -5 mmHg
MEAN: 0 mmHg
SIS: 40 mmHg
RVP HIGH ALARM RVP LOW ALARM +1 to 100 DIA: 15 mmHg
MEAN: 30 mmHg
SIS: 5 mmHg
RVP LOW ALARM -50 to RVP HIGH ALARM -1 DIA: -5 mmHg
MEAN: 0 mmHg
CVP HIGH ALARM CVP LOW ALARM +1 to 100 15 mmHg
CVP LOW ALARM -50 to CVP HIGH ALARM -1 -5 mmHg
LAP HIGH ALARM LAP LOW ALARM +1 to 100 20 mmHg

LAP LOW ALARM -50 to LAP HIGH ALARM -1 -5 mmHg

RAP HIGH ALARM RAP LOW ALARM +1 to 100 15 mmHg
RAP LOW ALARM -50 to RAP HIGH ALARM -1 -5 mmHg
The Parameters in GAS WINDOW(Mainstream & Sidestream)
CO2 UNIT KPa, %V, mmHg mmHg
GAS UNIT KPa, %V %V
ALARM LEVEL 1,2 2
GAS/RESP GAS, RESP GAS
O2 COMPENSATE 1-100 vol%, OFF 21%
0-100 vol% ( ONLY FOR ISA CO2, IRMA2
N2O OMPENSATE 0%
CO2 )
CO2 SCALE 6%,10%,Auto scale 10%
O2/N2O SCALE 0-50%,0-100%, Auto scale 100%
AA SCALE 1,2,3,5,10,20%, Auto scale 20%
SIGNAL SWEEP 3mm/s, 6mm/s, 12.5mm/s, 25mm/s 12.5mm/s
WORK MODE MEASURE, STANDBY MEASURE
GAS ALARM ON,OFF OFF
ADULT NEONATE
APNEA ALARM 10s,15s,20s,25s,30s,35s,40s,OFF
30S 15S
AWRR LOW 1~(HIGH-1) 5 BrPM 15 BrPM
AWRR HIGH (LOW+1) ~120 30 BrPM 60 BrPM
EtCo2 LOW 0.4~(HIGH-0.1) (%V) 2.6%V
EtCo2 HIGH (LOW+0.1)~13(%V) 6.5%V
FiCo2 HIGH 0.4~ 13(%V) 1.3%V
EtO2,FiO2 LOW 18~(HIGH-1) (%V) 50%- ( For IRMA ICU: 25 )
EtO2,FiO2 HIGH (LOW+1)~105(%V) 100%
EtN2O, FiN2O LOW 1~(HIGH-1) (%V) 35%
EtN2O, FiN2O HIGH (LOW+1)~100(%V) 75%
EtDES, FiDES LOW 0.1~(HIGH-0.1) (%V) 5%
EtDES, FiDES HIGH (LOW+0.1)~18(%V) 10%
EtISO, FiISO LOW 0.1~(HIGH-0.1) (%V) 0.8%
EtISO, FiISO HIGH (LOW+0.1)~5(%V) 2%
EtENF, FiENF LOW 0.1~(HIGH-0.1) (%V) 0.5%
EtENF, FiENF HIGH (LOW+0.1)~5(%V) 1.5%
EtSEV, FiSEV LOW 0.1~(HIGH-0.1) (%V) 1%
EtSEV, FiSEV HIGH (LOW+0.1)~8(%V) 3%
EtHAL, FiHAL LOW 0.1~(HIGH-0.1) (%V) 0.5%
EtHAL, FiHAL HIGH (LOW+0.1)~5(%V) 1.5%
WAVEFOEM CO2,N2O,O2,AA CO2
ISO,ENF,HAL,DES,SEV
AGENT For IRMA(OR+) & IRMA(AX+) & HAL,AUTO
ISA(OR+) & ISA(AX+): AUTO
FILLED SIGNAL ON,OFF OFF
ZERO Only for Mainstream

The Parameters in CSM WINDOW

EEG Gain 25uV,50-250uV 100uV
CSM ALARM ON,OFF OFF
CSI LOW 1~(HIGH-1) 35%
CSI HIGH (LOW+1)~100 60%
SYSTEM DEFUALT
ALARM VOLUME 1,2,3,4,5,6,7 1
CALENDAR SOLAR, CHRISTIAN CHRISTIAN
ADUL\NEONATE ADUL,NEONATE ADULT
BED NUMBER 1..99 01

APPENDIX II
MONITOR ERROR MESSAGES
Message cause Alarm indication explanation

ECG ERROR MESSAGES
ECG cable is not connected to the
ECG NO CABLE Connect ECG cable SILENCE, alarm will be disabled and
system
ignore this fault.
Check for any possible Alarm level 3, Pressing ALARM
sources of signal noise SILENCE, alarm will be disable and
form the area around the ignore this fault.
ECG NOISE ECG signal is noisy or saturated. cable and electrode, and
check the patient for great
motion and also check the
lead wires.
Make sure that all Alarm level 2, Pressing ALARM
ECG CHECK Reference lead or more than one electrodes and patient SILENCE, alarm will be disable and
LEADS chest lead is not properly connected. cable are properly ignore this fault.
connected
Make sure that mentioned Alarm level 2, Pressing ALARM
ECG CHECK Mentioned leads are not properly
electrode is properly SILENCE, alarm will be disable and
LA,RA,LL connected.
connected ignore this fault.
ECG SIGNAL ECG amplitude is lower than Check the situation of the
WEAK standard limit chest leads
Power off and then on the
system .If this message is Alarm level 2, Pressing ALARM
ECG DEFECT ECG module failure displayed again the user SILENCE, alarm will be disable and
should contact local After ignore this fault.
Sale Service.
RL or other leads are not properly
CHECK RL OR electrodes and patient SILENCE, alarm will be disable and
connected when ECG lead is V,
ALL cable are properly ignore this fault.
aVR, aVF or aVR.
connected
CHECK LL OR LL or other leads are not properly electrodes and patient SILENCE, alarm will be disable and
ALL connected when ECG lead is I cable are properly ignore this fault.
connected
CHECK LA OR LA or other leads are not properly electrodes and patient SILENCE, alarm will be disable and
ALL connected when ECG lead is II cable are properly ignore this fault.
connected


CHECK RA OR RA or other leads are not properly electrodes and patient SILENCE, alarm will be disable and
ALL connected when ECG lead is III cable are properly ignore this fault.
connected
RESP ERROR MESSAGES
Alarm is activated when RR ALARM
RESP CHECK The RESP leads are not properly alarm level 3 is "ON". Pressing ALARM SILENCE,
LEADS connected. The message is blinking alarm will be disabled and ignore this
fault.
Non-respiration condition overruns alarm level 1 Pressing ALARM SILENCE, alarm is
APNEA
adjusted time The message is blinking suspended for at least 120s.
RESP ERROR MESSAGES
Alarm level 3, the message is blinking
Make sure that all Alarm is activated when RR ALARM
RESP CHECK The RESP leads are not properly
electrodes, lead are is "ON". Pressing ALARM SILENCE,
LEADS connected.
properly connected alarm will be disabled and ignore this
fault.
SPO2 ERROR MESSAGES
Make sure that the probe Alarm level 3, the message is blinking.
SPO2 probe is not connected to the
SPO2 NO PROBE is correctly connected to Pressing ALARM SILENCE, alarm
monitor.
the monitor. will be disabled and ignore this fault.
Alarm level 2, the message is blinking.
SPO2 PROBE
The SPO2 probe is damaged Change the SPO2 probe. Pressing ALARM SILENCE, alarm
DEFECT
will be disabled and ignore this fault.
Make sure that SPO2 Alarm level 2, the message is blinking.

SPO2 PROBE SPO2 probe may be detached from
probe is properly attached Pressing ALARM SILENCE, alarm
OFF the patient.
to the patient will be disabled and ignore this fault.

Make sure that SPO2
Alarm is activated when SPO2
SPO2 CHECK SPO2 probe is not properly probe is properly
ALARM is "ON". Pressing ALARM
PROBE positioned to the patient connected to the patient
SILENCE, alarm is suspended for at
(refer to page 6-2).
least 120s.
Make sure that SPO2
SPO2 HIGH Alarm is activated when SPO2
This may be caused by entering probe is properly
AMBIENT ALARM is "ON". Pressing ALARM
environmental light into the probe connected to the patient
LIGHT SILENCE, alarm is suspended for at
(refer to page 6-2).
least 120s.
Move the sensor to
SPO2 is not calculable due to some another place, provoke
SPO2 SEARCH
reasons such as long time motions. blood recycle, and calm
the patient.
SPO2 SIGNAL The SPO2 signal amplitude is too Change the place of the
WEAK weak or undetectable. probe.

Power off and then on the Alarm level 2,the message is blinking.
system .If this message is Pressing ALARM SILENCE, alarm
SPO2 DEFECT SPO2 module failure displayed again, the user will be disabled and ignore this fault.
should contact local After
Sale Service.
Make sure that the probe Alarm level 3,the message is blinking.
SPO2 probe is disconnected from
SPO2 ASYSTOLE is correctly connected to Pressing ALARM SILENCE, alarm
the monitor.
the monitor. will be disabled and ignore this fault.
SPO2 PROBE
The SPO2 probe is damaged Change the SPO2 probe. Pressing ALARM SILENCE, alarm
DEFECT
NIBP ERROR MESSAGES
SELF-TEST
NIBP hard ware module failure Pressing ALARM SILENCE, alarm
FAILED
Cuff is completely unwrapped, no
LOOSE CUFF Pressing ALARM SILENCE, alarm
cuff attached.
Use adult cuff instead of neonate Alarm level 2, the message is blinking.
MODE ERROR cuff or occlusion happened in air Pressing ALARM SILENCE, alarm
way will be disabled and ignore this fault.
AIR LEAK Air leak in cuff, tube or connector Pressing ALARM SILENCE, alarm
Unstable pressure value (e.g. kinked Alarm level 2, the message is blinking.
AIR PRESSURE
hoses) because valve cannot open Pressing ALARM SILENCE, alarm
ERROR
normally. will be disabled and ignore this fault.
Very weak patient signal due to a Alarm level 2, the message is blinking.
SIGNAL WEAK loosely wrapped cuff or extremely Pressing ALARM SILENCE, alarm
weak pulse from patient. will be disabled and ignore this fault.
Measuring pressure is more than Alarm level 2, the message is blinking.
RENG
upper limit (255mmHg)for adult or Pressing ALARM SILENCE, alarm
EXCEEDED
(135mmHg) for neonate will be disabled and ignore this fault.
EXCESSIVE Arm movement, noisy signal or
Pressing ALARM SILENCE, alarm
MOTION irregular pulse(e.g. arrhythmia)
OVER Measuring pressure exceeded safe Alarm level 2, the message is blinking.
PRESSURE software limit, 290 mmHg for adult Pressing ALARM SILENCE, alarm
SENSED and 145mmHg for neonate. will be disabled and ignore this fault.
Large motion artifact that saturates Alarm level 2, the message is blinking.
SIGNAL
the amplifier's amplitude handling Pressing ALARM SILENCE, alarm
SATURATE
capability will be disabled and ignore this fault.
PNEUMATIC
Leakage during leak test Pressing ALARM SILENCE, alarm
LEAK

Measuring time exceeds 120 Alarm level 2, the message is blinking.

TIME OUT seconds for adult or 90 seconds for Pressing ALARM SILENCE, alarm
neonate will be disabled and ignore this fault.
Error occurs in pump, A/D Alarm level 2, the message is blinking.

SYSTEM
sampling, pressure transducer or Pressing ALARM SILENCE, alarm
FAILURE
software. will be disabled and ignore this fault.
NIBP DEFECT NIBP module failure Pressing ALARM SILENCE, alarm
The Charge of battery is low so
NIBP measurement is not possible
LOW BATTERY Pressing ALARM SILENCE, alarm
(while the monitor is working with
battery
NIBP NO
No NIBP module is installed.
MODULE
NIBP stop key has been pressed
STOP PRESSED
during measurement.
Measurement is stopped by NIBP
NIBP STOP
module because of special reason.
NIBP LEAKAGE
Successful leakage test
O.K
IBP ERROR MESSAGES

IBP1/IBP2 NO Channel 1 or 2 transducer is not Check the transducer blinking. Pressing ALARM SILENCE,
SENSOR connected. connection. alarm will be disabled and ignore this
fault.
IBP1/IBP2 IBP1 or IBP2 signal is in out of Press <AUTO SCALE>

ADJUST SCALE display range for about 5 seconds. in IBP WINDOW menu.

This condition occurs when the

maximum and minimum values of a
pulsatile pressure signal (Just for
●Check patient and do
IBP, ART, PAP, RVP and LVP
necessary treatment
labels) differ by less than 3mmHg.In
●Turn on the stopcock to
this case, only Mean pressure is
patient and turn it off to
displayed in this state. Alarm level 3, The message is
IBP1/IBP2 the atmospheric pressure.
This message can be caused by the blinking. Pressing ALARM SILENCE,
STATIC ●Follow hospital
following reason: alarm will be disabled and ignore this
PRESSURE procedure for dislodging
● A physiological condition e.g. fault.
catheter.
asystole
●Follow hospital
● Transducer turned off to the
procedures for clotted
patient.
catheters.
● A catheter tip lodged against a
vessel wall.
● A clot on the catheter tip.
● Check all IBP
connections and
IBP signal can’t be processed by the
IBP1/IBP2 measurement setup are
software because the signal is weak
SEARCH proper or not.
or less pulsatile.
● Check patient status and
treat if necessary.

GAS (SIDESTREAM) ERROR MESSAGES

on and if problem still Alarm level 2. Pressing Alarm
SYSTEM FAULT Sensor error exists, contact after Silence, Alarm will be disabled and
sales service of ignore this fault.
manufacturer
CHECK Alarm level 3. Pressing Alarm
SAMPLING IR signal low Change sampling line silence, alarm will be disabled and
ignore this fault.
LINE
SAMPLING Remove obstruction
otherwise change the Alarm level 2. Pressing alarm Silence,
LINE Sampling line occlusion
sampling line by a Alarm will be disabled for 120sec.
CLOGGED correct one.
off and on the system Alarm level 2. Pressing alarm Silence,
CO2 INVALID and if again this Alarm will be disabled and ignore this
accuracy range.
message appears contact fault.
after sales service of
manufacturer.
Alarm level 2. Pressing alarm Silence,
O2 INVALID Alarm will be disabled and ignore this
fault.
N2O INVALID Alarm will be disabled and ignore this
fault.
AGENT Agent outside specified problem still exists,
Alarm will be disabled and ignore this
INVALID accuracy range. contact After sales
fault.
ACCUTACY Zero the sensor, if the
INVALID, Alarm will be disabled and ignore this
fault.
PLEASE ZERO. service of manufacturer.
INVALID on and if problem still
Ambient pressure outside Alarm level 2. Pressing alarm Silence,
AMBIENT exists, contact after
operating range. Alarm will be disabled for 120 sec.
sales service of
PRESSURE
manufacturer.
Internal temperature outside Alarm level 2. Pressing alarm Silence,
operation range. Alarm will be disabled for 120 sec.
sales service of
TEMPERATURE
manufacturer.
REPLACE O2 Replace O2 sensor by a
O2 sensor lifetime is passed. silence, Alarm will be disabled and
SENSOR new one.
will ignore this fault.
O2 SENSOR Replace O2 sensor by a Alarm level 2. Pressing alarm Silence,
Sensor failure
ERROR new one. Alarm will be disabled for 120 sec.


being disconnected from the
O2 SPAN CALIB Perform room air Alarm level 2. Pressing Alarm
sampling line or the
REQUIRED calibration. silence, alarm is suspended for 120S.
operating temperature for
oxygen sensor changes
significantly.
ZERO CO2 value is more than 800 Perform automatic

REFERENCE PPM (0.80%V) and zeroing procedure in an Alarm level 2. Pressing alarm Silence,
CALIB measurement accuracy is environment with CO2 Alarm will be disabled for 120 sec.
low. less than 0.80%V.
REQUIRED
Connect sensor if
Alarm level 3 Pressing alarm Silence,
NO SENSOR Alarm will be disabled and ignore this
system. Contact after sales
fault.
If it is set manually or no
SENSOR breath is detected for 30 min
Enter GAS window and set
STANDBY WORK MODE on
mmHg for more than 30 min MEASURE.
MODE or when the monitor does not
identification and
measurement could not
be guaranteed.
AGENT ID
breathing circuit
UNRELIABLE3 - High concentrations of
are present in the
breathing circuit
3
it is only available for ISA AX+/OR+.

GAS (Mainstream) ERROR MESSAGES

on and if problem still Alarm level 2. Pressing Alarm
SYSTEM FAULT Sensor error exists, contact after Silence, Alarm will be disabled and
sales service of ignore this fault.
manufacturer
REPLACE
IR signal low Change the adaptor silence, alarm will be disabled and
ADAPTOR ignore this fault.
There is no adaptor
NO ADAPTOR Connect the adaptor silence, alarm will be disabled and
connected to the sensor.
ignore this fault.
off and on the system Alarm level 2. Pressing alarm Silence,
CO2 INVALID and if again this Alarm will be disabled and ignore this
accuracy range.
message appears contact fault.
after sales service of
manufacturer.
O2 INVALID Alarm will be disabled and ignore this
fault.
N2O INVALID Alarm will be disabled and ignore this
fault.
AGENT Agent outside specified problem still exists,
Alarm will be disabled and ignore this
INVALID accuracy range. contact After sales
fault.
ACCUTACY Zero the sensor, if the
INVALID, Alarm will be disabled and ignore this
fault.
PLEASE ZERO. service of manufacturer.
Ambient pressure outside Alarm level 2. Pressing alarm Silence,
operating range. Alarm will be disabled for 120 sec.
sales service of
PRESSURE
manufacturer.
Internal temperature outside Alarm level 2. Pressing alarm Silence,
operation range. Alarm will be disabled for 120 sec.
sales service of
TEMPERATURE
manufacturer.
O2 PORT Adapter O2 port Clogged or Alarm level 2. Pressing alarm Silence,
Connect the adaptor
FAILURE plugged. Alarm will be disabled for 120 sec.
REPLACE O2 Replace O2 sensor by a
O2 sensor lifetime is passed. silence, Alarm will be disabled and
SENSOR new one.
will ignore this fault.
ROOM AIR O2 being disconnected from the
Perform room air Alarm level 2. Pressing Alarm
CALIB CALIB sampling line or the
calibration. silence, alarm is suspended for 120S.
operating temperature for
REQUIRED
oxygen sensor changes
significantly.

Connect sensor if
Alarm level 3 Pressing alarm Silence,
NO SENSOR Alarm will be disabled and ignore this
system. Contact after sales
fault.
If it is set manually or no
SENSOR breath is detected for 30 min
Enter GAS window and set
STANDBY WORK MODE on
mmHg for more than 30 min MEASURE.
MODE or when the monitor does not
identification and
measurement could not
be guaranteed.
AGENT ID
breathing circuit
UNRELIABLE4 - High concentrations of
are present in the
breathing circuit
4
it is only available for IRMA AX+/OR+.

CSM ERROR MESSAGES
●Check all neuro

sensors and their
connections.
●Check the patient
cable. If not
Placement of neuro
connected, then
sensors and their
connect it. If faulty,
CSM ELECTROD connections might be in
replace patient
ALARM problem. This alarm can
cable.
also be caused by high
●Check if either of
frequency instrument.
the neuro sensors
are disconnected or
badly connected.
●Replace faulty
sensor.
●Check that all
neuro sensors and
cable connections
are correctly
connected.
●Has the use of any
mechanical device
If the impedance of the
that could generate
white or black sensors
high frequency
exceeds 1kΩ, the SQI
activity (e.g. patient
will fall gradually. Poor
warmer) been
impedance conditions
initiated or is any
may cause the SQI to
such device in close
fall to 50%. Artefacts
proximity to the
can have many causes:
CSM neuro
CSM SQI LOW high frequency
sensors?
instrument, EMG, etc.
If possible move
are typical causes. If
disturbing device
SQI falls because of
away from the
extensive use of high
neuro sensors.
frequency instrument, it
●Check grounding
will rise as soon as the
of disturbing
high frequency
device.
instrument is stopped
●Reduce the
influence from
disturbing device by
disconnecting CSM
Power to let the
CSM module run
from the battery.

●Check that neuro

sensors are not dry.
●Check that the
skin has been
CSM If sensor impedance is >
cleaned properly.
IMPEDANCE 5kΩ the CSI, BS and
HIGH ●Clean and prepare
EMG will be blanked
skin as described in
this manual and
attach new neuro
sensors.
●Try to establish
CSM module is off or it
wireless
is on but wireless
CSM LINK OFF communication.
communication is not
Refer to section 12-
established.
2-2
ST ERROR MESSAGES
●Check the ISO and

The ST algorithm has
ST measuring
calculated value +1mV
ST OUT OF points.
HIGH RANGE
outside the high end of
●Observe the
the ST measurement
patient and treat if
range.
clinically indicated.
●Check the ISO and
The ST algorithm has
ST measuring
calculated value -1mV
ST OUT OF LOW points.
RANGE outside the low end of
●Observe the
the ST measurement
patient and treat if
range.
clinically indicated.
RECORDER ERROR MESSAGES
Turn the system off

and then on if
REC. problem still exists,
SOFTWARE Software error
ERROR contact After sales
service of the
manufacturer.
Turn the system off
and then on if
RECORDER problem still exist,
FAULT Hardware error
contact to After
sales service of the
manufacturer.
The recorder door is Close the recorder
DOOR OPEN
open door.
Insert a new paper
OUT OF PAPER Record paper finished. roll into the
recorder.
PRINTED HIGH The thermal head is too Stop operation for
TEMP hot. some minutes.

Turn the system off

and then on if
PRINTED HIGH Print head voltage is problem still exists,
VOL high. contact to After
manufacturer.
Turn the system off
and then on if
PRINTED LOW Print head voltage is problem still exists,
VOL low. contact to After
manufacturer.
Turn the system off
and then on if
TIME OUT The recorder could not problem still exists,
ERROR record. contact to After
manufacturer.

ALARM MESSAGES
ALARM SITUATION VISUAL PROMPTS AUDIO SOUND
ECG ALARMS
HEART RATE Heart rate violates ●HR value blinks.
Activated
ALARM adjusted alarm limits ●Alarm indicator flashes.
Heart beat is not
●"ECG ASYSTOLE" is
ECG ASYSTOLE detected in last 10 Activated
displayed.
seconds.
RESP ALARMS
Respiration rate
●RESP value blinks
RR ALARM violates adjusted Activated
alarm limits
Non-respiration
●Alarm indicator flashes
APNEA condition overruns Activated
●"RESP APNEA" blinks
adjusted time
SPO2 ALARMS
SPO2 violates
●SPO2 value blinks.
SPO2 ALARM adjusted alarm Activated
limits
Pulse beat is not
●Message "SPO2
SPO2 ASYSTOLE detected in last 10 Activated
ASYSTOLE" is displayed
seconds.
NIBP ALARMS
SYS violates
adjusted alarm limits ● SYS value blinks
SYS ALARM Activated
or violates lower than ●alarm indicator flashes.
50mmHg
DIA violates adjusted ● DIA value blinks
DIA ALARM Activated
alarm limits ●alarm indicator flashes.
MAP violates
adjusted alarm limits ● MAP value blinks
MAP ALARM Activated
or violates lower than ●alarm indicator flashes.
30mmHg
IBP ALARMS
SYS violates ● SYS value blinks

SYS ALARM Activated
adjusted alarm limits ●alarm indicator flashes.
DIA violates adjusted ● DIA value blinks

DIA ALARM Activated
alarm limits. ●alarm indicator flashes.
MEAN violates ● MEAN value blinks
MEAN ALARM Activated
adjusted alarm limits. ●alarm indicator flashes.

CO2 ( sidestream & Mainstream ) ALARMS

Respiration rate
●AWRR value blinks
AWRR ALARM violates adjusted Activated
alarm limits
End Tidal CO2
●EtCo2 value blinks
EtCo2 ALARM violates adjusted Activated
alarm limits
FiCo2 violates
●FiCo2 value blinks
FiCo2 ALARM adjusted high alarm Activated
limits
Non-respiration
APNEA condition overruns in Activated
●"RESP APNEA" blinks.
adjusted time
End Tidal Co2
●EtN2O value blinks.
EtN2O ALARM violates adjusted Activated
alarm limits
End Tidal Co2
●FiN2O value blinks.
FiN2O ALARM violates adjusted Activated
alarm limits
End Tidal Co2
●EtAA value blinks.
EtAA ALARM violates adjusted Activated
alarm limits
End Tidal Co2
●FiAA value blinks.
FiAA ALARM violates adjusted Activated
alarm limits
End Tidal Co2
●EtO2 value blinks.
EtO2 ALARM violates adjusted Activated
alarm limits
End Tidal Co2
●FiO2 value blinks.
FiO2 ALARM violates adjusted Activated
alarm limits
CSM ALARMS
Cerebral state index
●CSI value blinks.
CSI ALARM violates adjusted Activated
alarm limits ●Alarm indicator flashes.
ST ALARMS
ST segment value
●ST value blinks.
ST ALARM violates adjusted Activated
alarm limits

APPENDIX III
EMC
Warning
Use only the recommended bedside monitor accessory .Using the accessory other than in
relevant chapter may cause to increase the EMISSION or decrease the IMMUNITY of
system.
Warning
assured that the bedside monitor is used in the electromagnetic environment specified.
Warning
To prevent EMC effect on the monitor, the system should not be used adjacent to or stacked
with other equipment and that if adjacent or stacked use is necessary, the equipment should
be observed to verify normal operation in the configuration in which it will be used.
Warning
Do not use cellular phone in the vicinity of this equipment. High level of electromagnetic
radiation emitted from such devices may result in strong interference with the monitor
performance.
Guidance and manufacturer's declaration – electromagnetic emissions

The VIZOR10/VIZOR12 Patient Care Monitor is intended for use in the electromagnetic environment specified
below. The customer or the user of the VIZOR10/VIZOR12 should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
The VIZOR10/VIZOR12 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 VIZOR10/VIZOR12 is suitable for use in all
Harmonic emissions establishments, including domestic establishments and those
Class A
IEC 61000-3-2 directly connected to the public low-voltage power supply
network that supplies buildings used for domestic purposes.
Voltage fluctuations/
flicker emissions Complies
IEC 61000-3-3

Guidance and manufacturer's declaration – electromagnetic immunity

The VIZOR10/VIZOR12 Patient Care Monitor is intended for use in the electromagnetic environment specified
below. The customer or the user of the VIZOR10/VIZOR12 should assure that it is used in such an environment.
IEC 60601 Compliance

Immunity test Electromagnetic environment - guidance
test level level
Floors should be wood, concrete or

Electrostatic ±6 kV contact
ceramic tile. If floors are covered with
discharge (ESD)
synthetic material, the relative humidity
IEC 61000-4-2 ±8 kV air
should be at least 30%.
Electrical fast ±2 kV for power supply Mains power quality should be that of a
transient/burst lines typical commercial or hospital
IEC 61000-4-4 ±1 kV for input/output lines environment.
±1 kV differential mode Mains power quality should be that of a

Surge
typical commercial or hospital
IEC 61000-4-5 ±2 kV common mode environment.
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT Mains power quality should be that of a
Voltage dips, short
(>60% dip in UT) typical commercial or hospital
interruptions and
for 5 cycles environment. If the user of the
voltage variations on
VIZOR10/VIZOR12 requires continued
power supply input 70% UT operation, it is recommended that the
lines (30% dip in UT) VIZOR10/VIZOR12 be powered from an
IEC 61000-4-11 for 25 cycles uninterruptible power supply or a battery.
<5% UT
(>95% dip in UT)
for 5 sec
Power frequency Power frequency magnetic fields should be

(50/60 Hz) magnetic at levels characteristic of a typical location
3 A/m
field in a typical commercial or hospital
IEC 61000-4-8 environment.
NOTE UT is the a.c. mains voltage prior to application of test level.

Guidance and manufacturer's declaration – electromagnetic immunity

The VIZOR10/VIZOR12 Patient Care Monitor is intended for use in the electromagnetic environment specified below.
The customer or the user of the VIZOR10/VIZOR12 should assure that it is used in such an environment.
IEC 60601 Compliance Electromagnetic environment –

Immunity test
test level level guidance
Portable and mobile RF communications equipment
should be used no closer to any part of the
VIZOR10/VIZOR12, including cables, than the
recommended separation distance calculated from
the equation applicable to the frequency of the
transmitter.
Recommended separation distance
d = 1.17 P
d = 1.17 P 80 MHz to 800 MHz

Conducted RF 3 Vrms
3V
IEC 61000-4-6 150 kHz to 80 MHz
d = 2.33 P 800 MHz to 2.5 GHz
Radiated RF 3 V/m
3 V/m Where P is the maximum output power rating of the
IEC 61000-4-3 80 MHz to 2.5 GHz
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey, a
should be less than the compliance level in each
frequency range.b
Interference may occur in the vicinity of equipment
marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a
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 VIZOR10/VIZOR12 is
used exceeds the applicable RF compliance level above, the VIZOR10/VIZOR12 should be observed to verify normal operation. If abnormal
performance is observed, additional measures may necessary, such as reorienting or relocating the VIZOR10/VIZOR12.
b
Over the frequency range 150kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended separation distances between

Portable and mobile RF communications equipment and the VIZOR10/VIZOR12
The VIZOR10/VIZOR12 Patient Care Monitor is intended for use in the electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the VIZOR10/VIZOR12 can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters)
and the VIZOR10/VIZOR12 as recommended below, according to the maximum output power of the communications
equipment.
Separation distance according to frequency of transmitter
Rated maximum output m
power of transmitter
W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
d = 1.17 P d = 1.17 P d = 2.33 P
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
1 1.17 1.17 2.33
10 3.70 3.70 7.37
100 11.7 11.7 23.3
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m)
can be estimated 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 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.

APPENDIX IV
IRMA Design and theory
This section describes the basic concepts used in PHASEIN IRMA in terms of design, technical
solutions and gas measurement.
1. Basic design features
PHASEIN IRMA mainstream multi-gas probe consists of an IRMA sensor head, an oxygen sensor
cell (optional) and an airway adapter. As all necessary calibration constants are stored within each
IRMA sensor head, the probes can be replaced without the need for recalibration.
Figure 1. PHASEIN IRMA sensor head with airway adapter.
The IRMA sensor head includes a multi-channel IR bench, a barometric pressure sensor, a signal
processor, a power regulator, and a RS-232 digital interface.
Figure2. PHASEIN IRMA sensor head.
The ultra compact multi-channel IR micro bench comprises a high reliability infrared source, an
infrared chopper wheel with an integrated brush less DC micro motor, an infrared detector and all
necessary components for processing the infrared measurement signal.

Chopper wheel with brushless DC micro motor
Figure 3. IRMA multi-channel IR micro bench.
The airway adapter, with or without an oxygen port (optional), includes the optical components for
TM
measuring gases - the XTP windows that are transparent to light in the wavelength ranges of
interest.
Figure 4. IRMA airway adapter with oxygen port.
Figure 5. IRMA airway adapter without an oxygen port.
The ultra fast response time oxygen sensor is normally integrated in the IRMA sensor head
allowing proximal measurement of INSP/EXP oxygen concentrations.

Figure 6. IRMA ultra fast response time oxygen sensor.
2 Gas measurement and identification

The IRMA sensor head snaps in place on the top of the airway adapter that includes the optical
components for measuring all gases. The airway adapter is inserted between the endotracheal tube
and the Y-piece of the breathing circuit. The respiratory gas measurements are obtained by
continuously measuring the infrared gas absorption through the XTP windows in the gas flow
through the adapter.
To measure the concentrations and identify the gases, absorption of up to nine different
wavelengths of infrared light is measured.
Figure 7. PHASEIN IRMA IR light path through XTP airway adapter.
The measurement of CO2, N2O and anesthetic agents in the breathing gas mixture is based on the
fact that the different gas components absorb infrared light at specific wavelengths. A
microprocessor continuously calculates the CO2, N2O and anesthetic agent concentrations from the
infrared light absorption measurements using matrix calculations to identify which anesthetic agents
are present in the gas mixture..
Oxygen does not absorb infrared light to the same extent as other breathing gases and is therefore
measured using an ultra rapid response time oxygen sensor (see Section 2.2 Oxygen measurement).

2.1 Infrared measurement technology
The absorption spectra for CO2, N2O and the five anesthetic agents halothane, enflurane,
isoflurane, sevoflurane and desflurane are shown in the figure below.
Figure 8. Absorption spectra.
PHASEIN IRMA uses the absorption peaks at 4.2 and 3.9 µm for the measurement of CO2 and
N2O respectively, and five different wavelengths in the 8-12 µm range for anesthetic agent
measurements. Two additional wavelengths beside the absorption peaks are used as references. To
measure the absorption of light at these wavelengths, a broadband infrared radiation source is used.
The light transmitted from the infrared source passes through the XTP windows and is then filtered
using a set of narrow optical band pass filters. The individual filters are mounted in a rapidly
rotating filter wheel that intersects the light path before the light reaches the infrared detector.
Figure 9. Optical path.
No radiation will be absorbed if the airway adapter is empty. The output signal from the detector
will thus have its maximum amplitude at a concentration of zero, with lower amplitudes at higher
concentrations.

2.2 Oxygen measurement

A fuel cell oxygen sensor uses a membrane that allows diffusion of O2 into the sensor. Inside the
sensor, there is a sensing electrode (cathode) made of a noble metal such as gold or platinum, and a
working electrode made of a base metal such as lead or zinc. The electrodes are immersed in an
electrolyte. Fuel cell oxygen sensors are current generators and do not require any external power
supply. By connecting a resistor between the anode and the cathode, a voltage proportional to the 02
concentration is generated. Since the measurement involves a chemical reaction, the fuel cell is
gradually consumed during the process (also when the equipment is not in use), and requires
replacement at regular intervals.
PHASEIN's oxygen sensor is specially designed to provide an ultra fast response time, thus
allowing a breath-by-breath analysis of the oxygen waveform at a proximal location (i.e. between
the patient's endotracheal tube and the Y-piece of the breathing circuit). The vast majority of
oxygen sensors available on the market are normally too slow for a breath-to-breath gas analysis.
Figure 10. IRMA ultra fast response time
For monitors, anesthesia machines and ventilators already equipped with oxygen measuring
devices, the IRMA sensor is available with an O2 sensor dummy instead of the normal oxygen
sensor. Figure 11 shows both the normal O2 sensor and the oxygen sensor dummy.
Figure11. Oxygen sensor dummy and oxygen sensor.
The oxygen sensor dummy can be replaced at any time by a normal sensor to allow oxygen
measurements with the IRMA sensor.

TM
3 PHASEIN XTP airway adapter
The disposable airway adapter is inserted between the endotracheal tube and the Y-piece of the
breathing circuit. The respiratory gas measurements are obtained through the XTP windows in the
sides of the adapter.
As the airway adapter is positioned directly in the airway, its performance can be affected by water
vapor, patient secretions or nebulized medications that can accumulate on the adapter's windows.
The water vapor can condense on the surface of the adapter windows in the format of small discrete
water droplets. This condensation can affect the light absorption through the windows thus affecting
the precision of the measurement.
The design and material technology of the XTP windows have special features that prevent a
decrease in performance when water vapor is present.
The root cause of water droplet formation is the difference in surface tension between the plastic
and water. This mismatch means that the water condenses into discrete droplets with a high contact
angle. Figure 12 illustrates a water droplet with various contact angles showing the effects of
condensed water on light transmission.
Figure 12. Effect of condensed water on light transmission.
The XTP windows are specially designed using the latest advances in material technology to
provide a window minimizing the impact of water vapor on light transmission. Figure 13 illustrates
the light transmission in a XTP window.
Figure13. Light transmission through a XTP window
For optimal results, the airway adapter shall not be placed between an ET tube and an elbow, as this
may allow patient secretions to block the adapter windows. The XTP airway adapter shall be
positioned with its windows in a vertical position to help keep patient secretions from pooling on
the windows.

The airway adapter is designed as a disposable for both adult/pediatric and infant applications.
The adult/pediatric adapter is available with or without an oxygen port.
Figure 14. IRMA airway adapters:

Adult/pediatric with and without an oxygen port and infant adapter.
The airway adapter with an oxygen port is equipped with a hydrophobic bacteria filter to protect the
oxygen sensor from contamination. Figure.15 illustrates the flow of gases in the adapter and the
location of the hydrophobic bacteria filter.
Figure15. Flow of gases through an IRMA airway adapter with an oxygen port.
For monitors, anesthesia machines and ventilators already equipped with oxygen measuring
devices, the airway adapter is available without an oxygen sensor port (see Fig.15).
Warning
Do not use the IRMA adult/pediatric airway adapter with infants as the adapter add 6 ml
dead space to the patient circuit.
The IRMA airway adapter has specially designed connectors for minimizing the dead space and can
be used even for very small patients. The infant adapter is available without an oxygen port only.

Effect of water vapor

The total pressure of the gas mixture is estimated by measuring the actual barometric pressure in the
IRMA sensor .The partial pressure and the volume percentage of CO2, N2O, O2 and anaesthetic
agents depend on the amount of water vapor in the breathing gas. The O2 measurement will be calibrated to
show 20.8% at actual ambient temperature and humidity level, instead of showing actual partial pressure.
20.8% O2 corresponds to the actual O2 concentration in room air with 0.7%H2O concentration (for
example at 25°C and 23% RH).
The measurement of CO2, N2O and anaesthetic agents (e.g. all gases measured by the IR-bench) will
always show the actual partial pressure at the current humidity level.
The effects of water vapor are illustrated by the examples in the following table.O2 is assumed to be
room air calibrated at 25ºC and 23%RH. The two columns to the right show the relative error in
displayed concentrations when adding or removing water vapor from the gas mixture, and
referencing the measurement to dry gas conditions at actual temperature and pressure (ATPD) or
saturated conditions at body temperature (BTPS).
Temp RH P H2O Err(rel) err(rel) err(rel)[%]

[C] [%] [mbar] part. pres. [%] ATPD[%] BTPS
[mbar]
10 20 1013 2 0 -0.2 +6.0
20 20 1013 5 0 -0.5 +5.7
25 0 1013 0(ATPD) 0 0 +6.2
25 23 1013 7.3 0 -0.7 +5.5
25 50 1013 16 0 -1.6 +4.6
30 80 1013 42 0 -4.1 +2.0
37 100 1013 63(BTPS) 0 -6.2 0
37 100 700 63 0 -9.0 -2.8
The table above illustrates that the gas concentrations in the alveoli, where the breathing gas is
saturated with water vapor at body temperature (BTPS), are 6.2% lower than the corresponding
concentrations in the same gas mixture after removal of all water vapor (ATPD).
If calibration of O2 is not performed with room air humidity equal to 0.7% H2O, the difference
between the O2 concentration delivered by IRMA and the actual partial pressure of O2 will be
equal to the concentration of ambient water vapor -0.7%(O2 diff [%] = Conc H2O[%]-0.7%.
For example, if a room air calibration of O2 is performed at a humidity of 1.6% H2O
(corresponding to 50% RH at 25°C) the standard calibration value of 20.8% O2 will be 1.6%-
0.7%=0.9% too large. The correct O2 concentration (actual partial pressure of O2) at theses
conditions is (1-0.009)*20.8=20.6%O2.

APPENDIX V
ISA Theory and design
1. Gas measurements
The measurement of CO2, N2O and anesthetic agents is based on the fact that different gases
absorb infrared light at specific wavelengths. The analysis of respiratory gases by the ISA gas
analyzers are therefore performed by continuously measuring the infrared light absorption in the gas
flow through an infrared spectrometer. Oxygen, on the other hand, does not absorb infrared light to
the same extent as other breathing gases and is therefore measured using alternative methods.
The gas analysis
At the heart of an ISA gas analyzer, the SIGMA spectrometer is seated. The SIGMA spectrometer
uses a proprietary broadband infrared radiation source to transmit light through the gas sample.
Before reaching the gas sample, the light path is intersected by narrowband optical filters that only
let through light corresponding to selected wavelength peaks of the measured gases. At the other
end of the light path, a sensor detects the portion of the light that is not absorbed by the gas. The
amplitude of the detector output is an inverse function of the gas concentration. Thus, at a
concentration of zero, the amplitude is at its maximum.
If the gas sample is a mixture of several components that absorb light at the same wavelength, such
as a mixture of two anesthetic agents, the absorbed radiation will be the sum of the absorption of the
agents. To determine the concentration of each of the individual gases, several filters have to be
used. The ISA gas analyzers therefore uses the SIGMA spectrometer, which contains up to nine
different narrowband filters to facilitate simultaneous measurement of CO2, N2O and a mixture of
any two of the five anesthetic agents.
Figure 1. Gas absorption spectra

The selection of the optical filters within the spectrometer is crucial to the characteristics and
performance of the gas analyzers. The SIGMA spectrometer uses the strong absorption peaks at 4.2
and 4.5 µm for CO2 and N2O measurements and five wavelengths in the 8 to 10 µm long wave
infrared range (LWIR) for the anesthetic agent calculations. The LWIR contains strong absorption
peaks for the anesthetic agents and negligible interference from other common respiratory gases,
such as alcohol and acetone, that could degrade measurement accuracy.
In addition to the measurement filters, two optical filters appropriately located within the 4 to 10
µm range are used as references.
2. Oxygen measurement
Oxygen does not absorb infrared light to the same extent as other breathing gases and is therefore
measured using alternative methods. The ISA OR+ analyzer is fitted with a paramagnetic oxygen
sensor, and the ISA AX+ module is designed be fitted with either a paramagnetic or a galvanic
(fuel-cell) oxygen sensor.
Paramagnetic oxygen analysis
Paramagnetic oxygen analyses are based on measurements of the attractive force exerted by a
strong magnetic field applied to the oxygen molecules in a gas mixture. The paramagnetic analyzer
distinguishes oxygen from other gases as a function of their magnetic susceptibility. Due to its
paramagnetic nature, oxygen is attracted into the magnetic field, while most other gases are not. On
a scale, where oxygen is assigned the value 100, most other gases have a magnetic susceptibility of
close to zero.
The Servomex sensor
An oxygen sensor well suited for the ISA gas analyzer is the PM1116 paramagnetic oxygen sensor
from Servomex. In this sensor, a symmetrical non-uniform magnetic field is created. If oxygen is
present, it will be attracted into the strongest part of this field. Two nitrogen-filled glass spheres are
mounted on a rotating suspension within the magnetic field. Centrally on this suspension, a mirror
is mounted. A light beam projected on the mirror is reflected onto a pair of photocells. Oxygen
attracted into the magnetic field will push the glass spheres from the strongest part of the magnetic
field, causing the suspension to rotate. When this rotation is detected by the photocells, a signal is
generated and passed to a feedback system. The feedback system will pass a current around a wire
mounted on the suspension, causing a restoring torque that keeps the suspension in its original
position. The current flowing around the wire is measured. This current is directly proportional to
the oxygen concentration.

Figure 2. Oxygem measurement with Servomex PM1116 paramagnetic oxygen sensor.
The most important benefits of the paramagnetic oxygen sensor are:
•Fast rise time
•High stability and accuracy
•No chemicals to replace or renew
•Low maintenance requirements
Galvanic oxygen analysis
As an alternative to the paramagnetic sensor, the ISA gas analyzer is designed be fitted with a
galvanic oxygen sensor. A galvanic fuel-cell oxygen sensor uses a membrane that allows diffusion
of O2 into the sensor. Inside the sensor, there is a sensing electrode (cathode) made of a noble metal
such as gold or platinum, and a working electrode made of a base metal such as lead or zinc. The
electrodes are immersed in an electrolyte. Fuel-cell oxygen sensors are current generators and do
not require any external power supply. By connecting a resistor between the anode and the cathode,
a voltage proportional to the O2 concentration is generated.
Since the measurement involves a chemical reaction, the fuel cell is gradually consumed during the
process (also when the equipment is not in use), and requires replacement at regular intervals.
3. Sampling
A sidestream gas analyzer continuously removes a gas sample flow from the respiratory circuit, for
example a nasal cannula, a respiratory mask or the Y-piece of an intubated patient. The gas sample
is fed through a sampling line to the gas analyzer. The sampled gas is usually warm and humid, and
cools down in contact with the wall of the sampling line. Water therefore condenses in form of
droplets on the inner wall of the sampling line. These droplets could potentially occlude the
sampling line and interfere with the gas measurement.

The Nomoline
To overcome the shortfalls of current gas sampling solutions, the Nomoline sampling line has been
developed for the ISA sidestream gas analyzers.
Warning: Use only Nomoline sampling lines manufactured by PHASEIN.
Unlike traditional solutions that remove water vapor and collect water in a container, the Nomoline
sampling line incorporates a unique water separation section, the NOMO section. This section is
made of a special polymer and a hydrophobic bacteria filter that removes water vapor and aspired or
condensed water. Water and water vapor passes through the membrane-like surface of the sampling
line and evaporates into the surrounding air, while leaving O2, CO2 and anesthetic gases
unaffected.
Figure 3. The Nomoline (no moisture) sampling line.
To protect the ISA analyzer, the Nomoline includes a filter with the bacterial filter efficiency of
≥ 99.9980 %. It is important to be aware that secretions and nebulized medications may attach to
the surface of the bacteria filter, and may cause clogging.
Warning: Do not use the ISA gas analyzer with metered-dose inhalers or nebulized medications as
this may clog the bacteria filter.
The Nomoline sampling lines are specially designed for 50 ml/min low sample flow applications.
The Nomoline has a very low dead space that results in an ultra-fast rise time, making
measurements of CO2, N2O and anesthetic agents possible even at high respiratory rates. ISA
sidestream gas analyzers are therefore suitable for adult, pediatric and infant patients.
The Nomoline sampling line is available in 2 and 3 meter versions and comes with a male Luer
Lock type connector to work with different kinds of third-party sampling equipment, including
patient interfaces for intubated, nasal and oral sampling. Although the selection of optimal patient
interfaces is crucial, the Nomoline sampling line fits in any normal configuration.

Flow control
During normal operation, a sidestream gas analyzer is continuously fed with a small sample gas
flow. To pull the gas through the sampling line and maintain a steady flow, a high-precision flow
control system is required. In ISA sidestream gas analyzers, the flow control system consists of an
integrated micro pump, a zero valve and a flow controller. The pump is fitted with a low-power
brushless motor having three miniature ball bearings to ensure trouble free operation without
regular maintenance. Its balanced shaft design and integrated pneumatic filter virtually eliminate
pressure and flow variations.
System response
In any sidestream gas monitoring system, there are three major time parameters involved:
•Total system response time
•Delay time
•Rise time
When designing a sidestream gas monitoring system, the physical characteristics of several
components have to be considered. Parameters such as sampling volume, tubing material, tubing
diameter and the physical design of the sampling interfaces play decisive roles in determining the
responsiveness of the system.
Generally, the total system response time equals the delay time plus the rise time.
The delay time is defined as the time required for a step function change at the sampling site to
result in 10% of the final value. Parameters affecting the delay time are the sample flow rate, tubing
length and tubing inner diameter. In mainstream gas monitoring, where no tubing exist, the delay
time is virtually zero, whereas a sidestream system has a sample delay time of a few seconds.
The rise time is defined as the time required for a step function change at the sampling site to bring
about a rise from 10% to 90% of the final gas concentration value.
4. Gas data concentration
Gas measurement units
Gas concentration is reported in units of volume percent. The concentration is defined as:
Partial pressure of gas component
% gas = * 100
Total pressure of gas mixture
The total pressure of the gas mixture is measured by a cuvette pressure sensor in the ISA gas
analyzer.

For conversion to other units, the actual atmospheric pressure sent from the ISA sidestream
analyzer may be used, e.g.
CO2 in mmHg = (CO2 concentration) x (atm. pressure value in kPa from ISA) x (750 / 100).
Example: 5.0 vol% CO2 @ 101.3 kPa Ö 0.05 x 101.3 x 750 / 100 = 38 mmHg
Effects of humidity
The partial pressure and the volume percentage of CO2, N2O, O2 and anesthetic agents depend on
the amount of water vapor in the measured gas. The O2 measurement will be calibrated to show
20.8 vol% at actual ambient temperature and humidity level, instead of showing actual partial
pressure. 20.8 vol% O2 corresponds to the actual O2 concentration in room air with 0.7 vol % H2O
concentration (at 1013 hPa this equals for example 25°C and 23% RH). The measurement of CO2,
N2O, and anesthetic agents (e.g. all gases measured by the IR-bench) will always show the actual
partial pressure at the current humidity level.
In the alveoli of the patient, the breathing gas is saturated with water vapor at body temperature
(BTPS).
When the breathing gas is sampled, and passing the sampling line, the gas temperature will get
close to the ambient temperature before reaching the ISA sidestream gas analyzer. As the Nomoline
removed all condensed water, no water will reach the ISA gas analyzer. The relative humidity of the
sampled gas will be about 95%.
If CO2 values at BTPS are required, the following equation can be used:
EtCO2 (BTPS) = EtCO2 * ( 1 – ( 3.8 / Pamb) )
where:
EtCO2 = EtCO2 value sent from ISA [vol %] Pamb = Ambient pressure sent from ISA [kPa]
3.8 = Typical partial pressure of water vapor condensed between patient circuit and ISA [kPa]
EtCO2(BTPS) = EtCO2 gas concentration at BTPS [vol%]
O2 is assumed to be room air calibrated at a humidity level of 0.7 vol% H2O.
Spectral broadening
The presence of oxygen and nitrous oxide can cause some interference in the CO2 measurement.
This is known as spectral broadening.
Nitrous oxide, N2O:
ISA sidestream analyzers capable of N2O measurements automatically compensates for spectral
broadening caused by nitrous oxide.

When using an ISA sidestream gas analyzer without this capability, the current nitrous oxide
concentration should be transmitted to the ISA Gas analyzer using the SetN2O command.
For most applications, sufficient accuracy in CO2 measurement will be achieved by setting N2O to
one standard concentration used always with N2O in use, as recommendation 50 vol%, SetN2O 50
for actual concentrations in the span 30 – 70 vol% N2O. When N2O is not in use send SetN2O 0.
The default value is 0.
By using this range, see table below, the maximum CO2 error with N2O compensation on (30-70%)
will be limited to 3.2 % relative.
N2O range N2O parameter

0-30 vol% 0
30-70 vol% 50
Oxygen, O2:
ISA sidestream analyzers capable of O2 measurements automatically compensates for spectral

broadening caused by nitrous oxide.
When using an ISA sidestream gas analyzer without this capability, the current nitrous oxide
concentration should be transmitted to the ISA Gas analyzer using the SetO2 command.
For most applications, sufficient accuracy in CO2 measurement will be achieved by dividing the
oxygen concentration into three ranges: “high”, “medium” and “low”. By using these ranges, along
with the SetO2 values in the table below, the maximal relative CO2 error will be limited to 1.2%.
O2 range O2 parameter
0-30 vol% 0
30-70 vol% 50
70-100 vol% 85
5. Interfering gas and vapor effects
Gas
Gas or vapor CO2 Agents N2O
level
ISA CO2 ISA AX+ - 1) - 1)
4) 2)
N2O 60 V% - - 1) - 1)
HAL 4) 4 V% - 1) - 1) - 1)
ENF , ISO , SEV 4) 5 V% +8 % of reading 3) - 1) - 1)
DES 4) 15 V% +12 % of reading 3) - 1) - 1)
Xe (Xenon) 4) 80 V% -10 % of reading 3) - 1) - 1)
He (Helium) 4) 50 V% -6 % of reading 3) - 1) - 1)
Metered dose inhaler
Not for use with metered dose inhaler propellants
propellants 4)
C2H5OH (Ethanol) 4) 0.3 V% - 1) - 1) - 1) - 1)
C3H7OH (Isopropanol) 4) 0.5 V% - 1) - 1) - 1) - 1)
CH3COCH3 (Acetone) 4) 1 V% - 1) - 1) - 1) - 1)
CH4 (Methane) 4) 3 V% - 1) - 1) - 1) - 1)

CO (Carbon monoxide) 5) 1 V% - 1) - 1) - 1) - 1)
NO (Nitrogen monoxide) 5) 0.02 V% - 1) - 1) - 1) - 1)
O2 5) 100 V% - 2) - 2) - 1) - 1)
Note 1: Negligible interference, effect included in the specification “Accuracy, all conditions”
above.
Note 2: Negligible interference with N2O / O2 concentrations correctly set, effect included in the
specification “Accuracy, all conditions” above.
Note 3: Interference at indicated gas level. For example, 50 vol% Helium typically decreases
the CO2 readings by 6%. This means that if measuring on a mixture containing
5.0 vol% CO2 and 50 vol% Helium, the actual measured CO2 concentration will
typically be (1-0.06) * 5.0 vol% = 4.7 vol% CO2.
Note 4: According to the EN ISO 21647:2004 standard.
Note 5: In addition to the EN ISO 21647:2004 standard.

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HEYER Medical - VizOR 10 / VizOR 12

VIZOR10 Patient Monitor

INNOVATION AS A SERVICE TO THE PATIENT

Carl-Heyer Strasse 1-3

CHAPTER 9 IBP MONITORING…………….………………...…………………. 9-1

CHAPTER 19 PRODUCTION SPECIFICATION……………………...………… 19-1

1.1 General Warning

1-1 Heyer Medical AG – VizOR 10 / 12 Operator’s Manual Rev. 2.0 – 09/11

1-2 Heyer Medical AG – VizOR 10 / 12 Operator’s Manual Rev. 2.0 – 09/11

1-3 Heyer Medical AG – VizOR 10 / 12 Operator’s Manual Rev. 2.0 – 09/11

1.2 General Information

Humidity 20-90 %( None condensing)

Altitude -200 to 3000m

Power Supply 90-260VAC,50/60Hz

1-4 Heyer Medical AG – VizOR 10 / 12 Operator’s Manual Rev. 2.0 – 09/11

a. VIZOR12 Patient Monitor b. VIZOR10 Patient Monitor

Portable Patient Monitor performs monitoring of:

1-5 Heyer Medical AG – VizOR 10 / 12 Operator’s Manual Rev. 2.0 – 09/11

1.3 Screen Display

Figure1-2 Monitor Main Display

1-6 Heyer Medical AG – VizOR 10 / 12 Operator’s Manual Rev. 2.0 – 09/11

1.4 Button Functions

1-7 Heyer Medical AG – VizOR 10 / 12 Operator’s Manual Rev. 2.0 – 09/11

a. VIZOR12 Patient Monitor b. VIZOR10 Patient Monitor

1-8 Heyer Medical AG – VizOR 10 / 12 Operator’s Manual Rev. 2.0 – 09/11

a) MASIMO SPO2 b) YSI400/YSI700 Compatible

1-9 Heyer Medical AG – VizOR 10 / 12 Operator’s Manual Rev. 2.0 – 09/11

This symbol means "BE CAREFUL". Refer to the manual.

Figure 1-5 Rear Panel

Following sockets are on the rear panel as illustrate in Figure 1-5.

1-10 Heyer Medical AG – VizOR 10 / 12 Operator’s Manual Rev. 2.0 – 09/11

■ Network Interfaces (Socket ):

1-11 Heyer Medical AG – VizOR 10 / 12 Operator’s Manual Rev. 2.0 – 09/11

1.6 Built-in Battery

1-12 Heyer Medical AG – VizOR 10 / 12 Operator’s Manual Rev. 2.0 – 09/11

Chapter 2 System Configuration

Figure 2-1 HOME WINDOW

2-1 Heyer Medical AG – VizOR 10 / 12 Operator’s Manual Rev. 2.0 – 09/11

Figure2-2 HOME/SIGMA WINDOW

Figure 2-3 HOME/TREND WINDOW

2-2 Heyer Medical AG – VizOR 10 / 12 Operator’s Manual Rev. 2.0 – 09/11

■ To select trend graph of a specific parameter:

■ To change the display scale:

SCALE1 SCALE2 SCALE3 SCALE4 SCALE5 SCALE6

■ To select how long the trend graph is displayed:

■ To obtain trend data of a specific time:

■ To select time interval of trend in x-axis

2-3 Heyer Medical AG – VizOR 10 / 12 Operator’s Manual Rev. 2.0 – 09/11

Pick "ALARM" in HOME WINDOW to call up, the following menu:

Figure 2-4 HOME/ALARM WINDOW

2-4 Heyer Medical AG – VizOR 10 / 12 Operator’s Manual Rev. 2.0 – 09/11

2.5 HOME / SETUP WINDOW

CALENDAR available options are "SOLAR" and "CHRISTIAN".

2.6 SETUP / DEFAULT WINDOW

ECG SETTING WILL BE DEFAULT, ARE YOU SURE?

2-5 Heyer Medical AG – VizOR 10 / 12 Operator’s Manual Rev. 2.0 – 09/11

NIBP LIST WILL BE CLEARED, ARE YOU SURE?

CSM TREND WILL BE CLEARED, ARE YOU SURE?

ARR LIST WILL BE CLEARED, ARE YOU SURE?

2-7 HOME/PATIENT INFORMATION WINDOW

2-8 HOME/PATIENT INFORMATION WINDOW

2-6 Heyer Medical AG – VizOR 10 / 12 Operator’s Manual Rev. 2.0 – 09/11

2-9 HOME/RECORDER WINDOW