Documente Academic
Documente Profesional
Documente Cultură
ELECTROCARDIOGRAPH
Operators Manual
YM412i
Operators Manual
EU representative
TECNOMED 2000 S.L.
Valencia, 25-28012 Madrid Spain
Supplier
MEDIANA Co.,Ltd.
Wonju Medical Industry Park, 1650-1 Donghwa-ri,
Munmak-eup, Wonju-si, Gangwon-do, Korea
Tel: (82) 33 742 5400 Fax: (82) 33 742 5618
Manufacturer
MEDIGATE INC.
1720-26, Taejang-dong, Wonju-si, Gangwon-do, Korea
Tel: (82) 33 747 3552 Fax: (82) 33 747 3691
Warranty
The information contained in this document is subject to change without notice. Mediana
makes no warranty of any kind with regard to this material, including, but not limited to, the
implied warranties or merchantability and fitness for a particular purpose. Mediana shall not
be liable for errors contained herein or for incidental or consequential damages in connection
with the furnishing, performance, or use of this material.
Revision History
The document part number and revision number indicate its current edition. The revision
number changes when a new edition is printed in accordance with the version of the
documentation. Minor corrections and upgrades which are incorporated at reprint do not
cause the revision number to change. The document part number changes when extensive
technical changes are incorporated.
Contents
Chapter 1. Information ................................................................................................. 9
1. General Information................................................................................................ 10
2. Safety Information .................................................................................................. 11
Chapter 8. Specification............................................................................................. 89
Figures
Figure 2-1. Top Panel 19
Figure 2-2. Rear Panel 19
Figure 2-3. Right Panel 19
Figure 3-1 AC Power Input 27
Figure 3-2. Recording paper insertion 30
Figure 3-3. Interface Connector 30
Figure 3-4. Automatic Mode Report.. 31
Figure 4-1. Patient Cable Connector 34
Figure 4-2. Patient Cable 34
Figure 4-3. Connecting position of the limb lead electrodes 35
Figure 4-4. Connecting position of the chest lead electrodes 36
Figure 4-5. Arranging the patient cable. 36
Figure 5-1. Copyright Screen 38
Figure 5-2. Typical Screen of ECG 39
Figure 5-3. System MENU 40
Figure 5-4. MENU Configuration 41
Figure 5-5. Operation Mode (Automatic) Menu Screen 42
Figure 5-6 Print Format 4c*2.5s 43
Figure 5-7. Print Format 2c*5s 44
Figure 5-8. Print Format 1c*10s 45
Figure 5-9. Rhythm Lead Setting Screen(Automatic Mode) 46
Figure 5-10. Median Beats Report 47
Figure 5-11. Detail Parameter Report 47
Figure 5-12. Operation Mode (Manual) Menu Screen 48
Figure 5-13. Rhythm Leads Setting Screen(Manual Mode) 49
Figure 5-14. System Setup Menu Screen 50
Figure 5-15. System Setup - Physician Setting Screen 53
Figure 5-16. System Setup - Technician Setting Screen 54
Figure 5-17. System Setup Hospital Name Setting Screen 55
Figure 5-18. System Setup Beep Setting Screen 56
Figure 5-19. System Setup Patient Data Entry Setting Screen 57
Figure 5-20. Patient Data New Patient Registration Screen 61
Figure 5-21. Patient Data Patient ID Input Screen 61
Figure 5-22. Patient Data Name Input Screen 62
Figure 5-23. Patient Data Race Input Screen 63
Figure 5-24. Patient Data Physician and Technician Selection Screen 63
Figure 5-25. Patient Data Madication Input Screen 64
Figure 5-26. File Management Menu Screen 65
Figure 5-27. File Management ECGs List. 66
Figure 5-28. File Management ECGs List Select.. 66
Figure 5-29. File Management Print the ECG Data 67
Figure 5-30. File Management Transfer Patient Data 68
Figure 5-31. File Management Delete Patient Data... 68
Figure 5-32. File Management Change Patient Data. 69
Figure 5-33. File Management Delete All ECGs.. 69
Figure 6-1. Cleaning the Printer Head 73
Figure 6-2. Maintenance Menu Screen 75
Figure 6-3. Maintenance Firmware Version 76
Figure 6-4. Firmware upgrading Screen 78
Tables
Table 2-1. Display Description 20
Table 2-2. Key Description 21
Table 2-3. Panel and Label Symbols 22
Table 3-1. List of Components 26
Table 3-2. Top panel indicator for power source 27
Table 3-3. Battery Charging Status Indications 28
Table 5-1. Lead Labels 56
Table 5-2. Default Setting Value 58
Table 7-1. Troubleshooting 80
Table 8-1. Electromagnetic Emissions (IEC60601-1-2) .. 93
Table 8-2. Electromagnetic Immunity (IEC60601-1-2) 93
Table 8-3. Electromagnetic Immunity (IEC60601-1-2) 95
Table 8-4. Recommended Separation Distances. 96
Table 8-5. Cables (IEC60601-1-2) 97
This page is intentionally left blank.
Information
Chapter 1. Information
1. General Information
y The product YM412i bears the CE marking indicating its conformity with the
provisions of the Council Directive 93/42/EEC concerning medical devices and fulfills the
essential requirements of Annex I of this directive. It is class a (MDD) equipment.
y The product is designed to comply with IEC60601 requirements. It is a protection class I,
type CF device.
y The product complies with the electromagnetic immunity requirements of standard IEC
60601-1-2/EN 60601-1-2 Electromagnetic Compatibility Medical Electrical Equipment.
y The radio-interference emitted by this device is within the limits specified in
CISPR11/EN55011, class B.
y This manual is an integral part on the device. It should always be kept near the device.
Close observance of the information given in the manual is a prerequisite for proper device
performance and correct operation and ensures patient and operator safety. Please note
that information pertinent to several chapters is given only once. Therefore, carefully
read the manual once in its entirety.
y This manual is in conformity with the device specifications and standards on safety of
electro-medical equipment valid at the time of printing. All rights are reserved for device,
circuits, techniques, and software program appearing in this manual.
y To ensure patient safety, the specified measuring accuracy, and interference-free operation,
we recommend to use only original Mediana components. The user is responsible for
application of accessories from other manufacturers.
y The warranty does not cover damage resulting from the use of unsuitable accessories and
consumables from other manufacturers.
y The safety information given in this manual is classified as follows:
Warning
Indicates a hazard. If not avoided, the hazard can result in death or serious injury.
Caution
Indicates a potential hazard. If not avoided, this hazard may result in minor personal
injury and/or product/property damage.
2. Safety Information
It is strongly recommended that the user first review this document thoroughly before operating
the system.
Warning: The electrocardiograph is intended to be used in a hospital and
hospital facilities environment by trained medical personnel.
Warning: The device is not designed for use in areas of medically used rooms
where an explosion hazard may occur. An explosion hazard may result from
the use of flammable anesthetics, skin cleansing agents and disinfectants.
Warning: Before using the device, the operator must ascertain that it is in
correct working order and operating condition. In particular, all connectors
must be checked for signs of damage. Do not use the electrocardiograph or
any accessories if damaged.
Warning: When disconnecting the device from the power line, remove the plug
from the wall outlet first, before disconnecting the cable from the device.
Otherwise there is a risk of coming in contact with line voltage by inadvertently
introducing metal parts in the sockets of the power cord.
Warning: Magnetic and electrical fields are capable of interfering with the
proper performance of the device. For this reason make sure that all external
devices operated in the vicinity of the defibrillator comply with the relevant
EMC requirements. X-ray equipment, MRI devices, radio systems etc. are
possible sources of interference as they may emit higher levels of
electromagnetic radiation. Keep the device away from these devices and verify
the device performance before use.
Warning: Due to the risk of electrical shock, do not open the cover of the
equipment unless absolutely necessary and disassembly of the machine
should be done only by a maintenance worker who has the license from
Mediana.
Warning: Remove all the metal accessories the patient wears and then perform
measurement.
Warning: When unsure of the setup or the placement of the external power
connection, power the device using the internal power.
Warning: During use of equipment, avoid contact between the metal part
outside equipment and the patient.
Warning: Do not use this device along with high-frequency electrical operative
equipment, since it may damage the equipment or the patient.
Warning: This device is intended for use under the direct supervision of a
licensed health care practitioner.
Warning: To ensure patient safety, the conductive parts of the ECG electrodes
(including associated connectors) and other patient-applied parts should not
contact other conductive parts, including earth ground, at any time.
Caution: Before connecting the device to the power line, verify that the ratings
of your local power line are those indicated on the device nameplate.
Caution: Avoid humidity, high temperature, dust in the air, salt or sulfuric
material and avoid the unventilated place or the direct sunshine.
Caution: When cleaning the equipment, wipe it with sponge or something like
that wetted with soapy water and never use the detergent using alcohol,
ammonia or acetone as main ingredient.
Caution: When cleaning the equipment, pay special attention so that cleaning
liquid and so on may not soak into the inside of equipment.
Caution: Handle the electrode with care so that its inside surface is not
scratched.
Chapter 2. Introduction
Caution: Medical technical equipment such as the YM412i must only be used
by qualified and trained personnel.
1. Intended Use
The intended use of the cardiograph is to acquire multi-channel ECG signals from adult
patients from body surface ECG electrodes and to record, display, analyze, and store these
ECG signals for review by the user. The cardiograph is to be used in healthcare facilities by
trained healthcare professionals. Analysis of the ECG signals is accomplished with algorithms
that provide measurements, data presentations, graphical presentations, and interpretations
for review by the user.
The interpreted ECG with measurements and interpretive statements is offered to the clinician
on an advisory basis only. It is to be used in conjunction with the clinician's knowledge of the
patient, the results of the physical examination, the ECG tracings, and other clinical findings.
A qualified physician is asked to overread and validate (or change) the computer-generated
ECG interpretation.
Thermal
Printer Graphic
LCD
Keypad
1 2 3 4 5 6 7
I V1
II V2
III V3
aVR V4
aVL V5
aVF V6
8 9 10 11
Key Description
AC IN indicator(Green LED)
Equipotential terminal
LAN Connector
CE mark
EU representative
Manufacturer
Date of manufacture
SN Serial number
Keep dry.
This way up
TEL +82-33-742-5400
FAX +82-33-742-5618
1. List of Components
NOTE: The above pictures vary from the original in some points.
Caution: If in doubt the integrity of the AC power source, the device must be
operated from its internal battery.
YM412i can be operated with normal power source. Input voltage range of power is 100-
240VAC, and input frequency is 50/60Hz. Power cord connector is situated at the rear side.
NOTE: Even if the device is not turned on, the AC IN indicator ( ) is lit when the
AC power cord is connected into a mains outlet.
NOTE: If AC indicator is not lit, check the power cord, the AC power inlet,
the power / mains outlet.
Caution: When the voltage of the battery is very low, it is a possibility of not
operating.
NOTE: It is recommended that the device remain connected to AC power source when
not in use. This will ensure a fully charged battery whenever it is needed.
2) Battery status
If battery power is deficient, the battery capacity short warning Battery Low is displayed on
the screen. A warning message Battery Low appears and beep sounds before the device
shuts off. After that, the device automatically shut down. When warning message Battery
Low appears, all keys are not operation. Connect the device to an AC power source to avid
any loss of trends or setting.
NOTE: Even if the device is turned off, Battery indicator ( ) flashes while the
battery is recharged.
NOTE: A fully charge of a depleted battery takes approximately 6 hours while the
device is turned on/off.
Warning: Due to the risk of electrical shock, do not open the cover of the
equipment unless absolutely necessary and disassembly of the machine
should be done only by a qualified service engineer.
2) Check the paper supply. If it is necessary to insert a new paper, refer to 5. Loading the
Printer Paper for instructions.
As shown in the Figure 3-2 below, open printer cover, insert shaft into the thermal paper, and
then put it in the equipment.
As shown in the Figure 3-2, make the paper come out upside and then close the printer cover.
NOTE: When using the separately purchased printer paper, manufacturer or its agent
does not take responsibility for bad printing or product damage that occurs.
2) USB Connector
1) RS-232 Connector
1) RS-232 Connector
This is a communication device that transmits the measurement data to the PC. The
transmitted data may be viewed by using separate software. The PC in operation must use the
certified product, and Mediana is not responsible for problems that occur when using non-
certified products.
2) USB Connector
Use it only when upgrading firmware through USB memory stick. For firmware upgrade,
refer to Chapter 6. Cleaning and Maintenance.
3) LAN(RJ45) Connector
Function Reserve.
V5, V6
Calibration Pulse: This is the rectangular waveform shown in line of ECG trace. It
shows how much the cardiograph deflected the trace in response to a 1 mV
calibration pulse applied to the acquisition circuitry.
Rhythm Lead: The interpretive cardiograph can print ten seconds of one lead at the
bottom of the Auto report. This additional trace is a rhythm lead. Rhythm lead shows
the same ten seconds of ECG data as in the auto interpretive report.
Patient Information: This information is entered by the technician when the ECG is
taken.
System Information: Information about the settings at which the ECG was taken is
listed at the right of the Auto report.
Detection Result: This block gives standard interval and duration measurements in
milliseconds, and limb lead axis measurements in degrees. These are
representative values for the dominant beat pattern in the ECG.
Diagnosis Result: The measurements and interpretation can help the physician
save time when overreading reports.
Warning: For reasons of patient safety, use only the original Mediana patient
cable. Before connecting the cable to the device, check it for signs of
mechanical damage. Do not use a damaged cable.
2. Electrode Application
Careful application of the electrodes is the key to an interference-free ECG.
For quick, reliable and trouble-free application of electrodes, we recommend using the original
Mediana electrode.
3. Position of electrodes
Lay the patient on the bed in a relaxed state and get rid of any tension on the muscle. Clean
the area of contact with a moist tissue to allow stable contact between the skin and the
electrode. Shave the contact area if there is excess body hair, and precisely attach the
electrode. Incorrect attachment of the electrode affects the accuracy of the diagnosis;
therefore, it is critical to attach the electrode at the correct place. If the electrocardiogram is
unstable, check the status of the electrode, power supply (avoid using more than one
equipment per outlet), connection, et cetera.
AHA
IEC
Correct Incorrect
Figure 4-5. Arranging the patient cable
2) After completed successfully the booting, a copyright screen appears. The copyright screen
displays the company log and the version of system.
YM412i-V0.01
4) When the device detects valid signals, it displays real-time waveforms similar to Figure 5-2.
3) Press key, the device prints the most recent 10 seconds of ECG data and analyzes it.
5. System Menu
Press MENU key in order to enter the menu. Pressing MENU key shows detailed
menus as follows.
Configuration
z Selection of menu item: Move shadow box ( ) to the desired item, and press
z Changing the setting: Highlight the desired setting in the same manner as selection
41
Operation of YM412i
7. Operation Mode
1) Operation Mode (Automatic)
When set as Automatic Mode, the device prints the electrocardiogram over the past 10
seconds. The form the printed wave and other items to be printed on the report can be
selected at the follow sub-menu settings window.
Operation Mode(Automatic)
10mm/mV, and 20mm/mV). Move shadow box ( ) to the desired size, and
Speed: Choose between four different output speeds (5mm/s, 10mm/s, 25mm/s,
and 50mm/s). Move shadow box ( ) to the desired speed, and press (Enter) to
select.
Report Format: Report format can change by selecting 4c*2.5s, 2c*5s, 1c*10s.
No. of Copy: COPY key is used to output again the cardiogram data measured and
outputted just before. The copy can support up to 9 sheets.
Rhythm Lead: This is printed at the bottom of the report, serving as a standard to
other channels. There are 12 possible leads for use (I, II, III, aVR, aVL, aVF, V1, V2,
V3, V4, V5, V6). The default lead is Lead II. If other leads are needed, move shadow
box ( ) to Others, and press (Enter) to bring the sub-menu like below.
Print Median Beat: Choose whether to print the median value of the
electrocardiogram wave (the value of the middle of the wave) or not. If set as YES, the
median beat will be printed. If set as NO, the median beat will not be printed.
Print Detail Result: Choose whether to print the detail result or not. If set as YES,
the detail result (average value of the selected rhythm lead) will be printed. If set as
NO, the detail result will not be printed.
Muscle Filter: Choose whether to apply the muscle filter or not. If set to On,
muscle filter will be applied. If set to off, muscle filter will not be applied.
STOP
using (stop) key. The following options, including the form of the electrocardiogram
wave and the items to be printed on the report, can be set at the sub-menu setting window.
10mm/mV, and 20mm/mV). Move shadow box ( ) to the desired size, and press
(Enter) to select.
Speed: Choose between four different output speeds (5mm/s, 10mm/s, 25mm/s, and
50mm/s). Move shadow box ( ) to the desired speed, and press (Enter) to select.
Rhythm Leads: The outputted waves leads can be selected. 4 different combination
sets are available ([I, II, III], [aVR, aVL, aVF], [V1, V2, V3], and [V4, V5, V6]). In addition, 1
combination sets, customized by the user, can be customized and used. In order to
customize the combination set, move shadow box ( ) to C:[ , , ], and press
(Enter) to bring the sub-menu like below. Choose the desired lead.
Operation Mode(Manual)
Tip) To cycle between different combinational sets, press (CMODE). Each press of
(CMODE) will change the set from 1 to C. If not using the customized
combination set, the cycle will be from 1 to 4.
8. System Setup
Move shadow box( ) to the Last Name, and press (ENTER) key to show
the text input window.
Patient Data
Patient ID 0000000000
Last Name HAN
First Name SANG HUN
Race Unknown
Date of Birth 25.07.1973 (dd.mm.yyyy)
Height 000 cm
Weight 000 kg
Gender Male Female
Pacemaker Yes No
Physician No Others
Technician No Others
Location No. 1
Medication 1 1 2 3 No 5 6 7 Others
4 8 9 0
Medication 2 A B C DNo E F G Others
H I J
Text Input
Window
10 letters are shown in alphabetical order. The (up) key and the (down)
key will show the next 10 alphabets and the previous 10 alphabets, respectively.
If trying to type H, press number 8 on the keypad to display H on the third line of the text-
input window. The next letter A can be typed by pressing number 1.
1) Physician
Edit Up to 10 physicians may be recorded. If other physicians are edited, move shadow box
After select the desired Edit No., press (Enter). Then a text box that inputs name of the
physician shows, and the desired text can be typed. Refer to the text input tip when inputting
the name of the physician.
Delete If delete the physician, after select the desired Delete No., press (Enter).
2) Technician
Edit Up to 10 physicians may be recorded. If other technicians are edited, move shadow box
After select the desired Edit No., press (Enter). Then a text box that inputs name of the
technician shows, and the desired text can be typed. Refer to the text input tip when inputting
the name of the technician.
Delete If delete the technician, after select the desired Delete No., press (Enter).
3) Hospital Name
When you move shadow box ( ) to Hospital Name and press (Enter), a text box that
inputs name of the hospital shows, and the desired text can be typed. Refer to the text input tip
when inputting the name of the hospital.
System Setup
Physician [ List Edit ]
Technician [ List Edit ]
Hospital Name [ ]
Cart No. 1
Location No. 1
Date Format dd/mm/yy mm/dd/yy
Date 00.00.00
Time Format 12 24
Time(hh:mm) 00:00 AM PM
Units cm, kg in, lb
Lead Fail Beep Yes No
HR Beep Yes No
Lead Labels IEC AAMI
LCD1Light Off
2 3 4 5
[ 00 ] (min)
6 7 8 9 0
Patient Data EntryC
A B D E F G H
Displayed Patient Data Entry
I J
medigate hospital
4) Cart No.
When using multiple devices from multiple carts, each device can be assigned a cart number.
5) Location No.
When using multiple devices from multiple locations, each device can be assigned a location
number.
6) Date Format
Choose between two different formats of date (dd/mm/yy (Day/Month/Year) or mm/dd/yy
(Month/Day/Year).
7) Date
Set the current date.
8) Time Format
Choose between two different formats of time (12 hour format or 24 hour format)
9) Time(hh:mm)
Set the current time (adjusted according to the selected time format)
10) Units
Choose between two different unit system (cm, kg or in, lb) when displaying the patients
height and weight.
11) Beep
Set the alarm that heart rate beep, key press beep and warning beep. Move shadow box
( ) to On and press (Enter), a sub-window that setup of each beep shows, and the
14) Communication
The device provides external connectors (RS-232, LAN) on the rear panel to support
communication with PC.
Height Yes No
Weight Yes No
Race Yes No
Gender Yes No
Pacemaker Yes No
Physician Yes No
Technician Yes No
Room No. Yes No
Medication1 Yes No
Medication2 Yes No
Patient ID Check Yes No
Tip) Press (FILTER) key to switch between the modes. When pressing the key, a
sub-window (shown below) is displayed. Use the directional button to move the shadow box
( ) to the desired filter, and press (Enter) to apply the selected filter. Press ESC to
Manual Mode
9. Patient Data
Input the data of the patient. The following data can be input.
Tip) Press the (Patient) key to directly access the patient data input window (without
going through the menu).
1) New Patient
When registering a new patient, press YES. When editing the data of the existing patient,
press NO.
Patient Data
New Patient Yes No
Patient ID 0000000000
Last Name [ ]
First Name [ ]
Date of Birth 00.00.0000 (dd.mm.yyyy)
Height 000 cm
Weight 000 kg
Gender Male Female
Race unknown
Pacemaker Yes No
Physician No Others
Technician No Others
Room No. 00000
Medication 1 No Others
Medication 2 No Others
Comments [1]
[2]
[3]
The ID of a patient consists of 10-digit number. Move shadow box ( ) to the Patient ID
Input the name of the patient. Move shadow box ( ) to the name and press (Enter) to
input the name. Refer to the text input tip for inputting the name.
4) Date of Birth
Input the birthday of the patient. When inputting the day or the month, the number being
inputted cannot exceed 31 or 12, respectively.
5) Height, Weight
Input the height and the weight of the patient. The unit of the data can be selected at the
System Setup. Height and weight can be entered to the extent of 400cm, 400kg.
6) Gender
Input the gender of the patient.
7) Race
Choose and input the patients race. Press (Enter) at Race to list the selectable race. Select
the appropriate race and press (Enter) to input the data.
8) Pacemaker
Input whether the patient uses a pacemaker with this device.
9) Physician, Technician
Choose whether to input the related physicians and/or technicians. Press (Enter) at Others. A
sub-window will be displayed, selecting the physicians and/or technicians. Refer to the text
input tip to input the names.
11) Madication 1, 2
Input the prescribed medications for the patient. Refer to the text input tip to input the words.
1) Copy
Use when printing the ECG data measured up to the time of printing (as is or as adjusted).
Tip) Use (Copy) key to print directly (without going through Menu->File
Management->Copy)
NOTE: After the ECG report print at auto mode, the measured ECG data cannot copy
when the stored ECG data to file management (memory) print.
2) Manual Save
Use when manual saving the ECG data measured up to the time of measuring under non-
setting auto save mode.
Tip) Use (Save) key to save directly (without going through Menu->File
Management->Manual Save)
NOTE: After the ECG report print at auto mode, the measured ECG data cannot
manual save when the stored ECG data to file management (memory) print.
Tip) Press the (FILE) key to directly access the ECG list window (without going
through the menu).
Use the directional button to move the underline to the desired data, and press (Enter) to
select the data. Press (Enter) to bring the sub-menu like below. Choose the desired item.
NOTE: Before the ECG data transfer to PC, the Mecalyzer(PC program) set to the
standby.
NOTE: Refer to the Mecalyzer manual for more information of the Mecalyzer (PC
program).
File Management
Copy
Manual Save
ECG data list
Delete All ECGs
NOTE: Since the deleted patient or test record cannot be restored, caution must be
applied when deleting.
NOTE: The necessary time of data deleting is max. 10minutes.
11. Maintenance
Refer to this manual for Chapter 6. Cleaning and Maintenance -> 10. Device Management.
Warning: Disconnect the device from the power line before cleaning or
disinfecting its surface.
Warning: Do not spray, pour, or spill any liquid on the device, its accessories,
connectors or openings in the chassis.
Caution: Wipe the external surfaces of the cardiograph, patient cable and
electrodes with a soft cloth dampened in any of the approved cleaning
solutions.
Patient Cable
1) Disconnect the cable from the device before cleaning or disinfecting it. When
disconnecting the cable, be sure to pull on the connector, not on the cable.
2) Clean the cable by rubbing it down with a cloth moistened with soap water. Use a
disinfectant for disinfection. Do not immerse the cable in liquid.
Electrodes
In addition to the information given in this manual, observe the instructions for use of the
respective electrode types.
1) Discard disposable adhesive electrodes immediately after use to prevent that they are
reused.
2) Clean reusable electrodes immediately after removing them from the patient.
3) Peel off the adhesive foil before cleaning the electrodes (rests of the adhesive can be
removed with benzene).
4) Then use warm water and a small brush to clean the electrodes of cream or gel. Do not
7. Service
This device requires no routine service other than cleaning, battery maintenance, and
service activity which is mandated by users institution. For more information, refer to the
service manual. Qualified service personnel in the users institution should perform periodic
inspections of the device. If service is necessary, contact qualified service personnel or
Mediana service center.
Maintenance
Move shadow box( ) to the Maintenance, and press (ENTER) key to show the
password input window. Input the password 1560, and press (Enter) to show the
maintenance window.
Configuration
Enter Password
Maintenance
1) Demo Mode
If set to On, normal ECG signal will be applied.
2) LCD Test
To verify or optimize cardiograph LCD state, use the LCD test. Move shadow box( )
to LCD Test, and press (ENTER) key to display the test screen. If something is the matter
with the LCD, contact qualified service personnel or Mediana service center.
3) Printer Test
The Printer Test is used to verify that the cardiograph printer is able to correctly print the test
page. Use this to verify proper printer performance or when reports appear to have print
quality errors.
Move shadow box( ) to Printer Test, and press (ENTER) key to print the printer test
page. If something is the matter with the test page, clean the printer header. The method of
printer cleaning refers to Chapter 6. Cleaning and Maintenance. Contact qualified service
personnel or Mediana service center. if problem persists after printer header cleaned.
4) Firmware Ver.
Move shadow box( ) to firmware Ver., and press (ENTER) key to show the firmware
version.
Maintenance
YM412i Ver1.0/1.0
2006-2007 Mediana Co.,Ltd.
If the device has not been used 2 or more months, the Ni-MH battery will need charging. To
charge the battery, connect the device to an AC power source.
NOTE: Storing the device for 2 or more months without charging the battery may
degrade the battery capacity. Before using the battery, charge it for at least 6
hours before use.
NOTE: The battery should be removed from the device if placed in storage or will
not be used for a long period.
Mediana recommends that the devices Ni-MH battery be replaced if it has been stored for
2years or more. Refer to the service manual for battery replacement.
Caution: If any problem during Firmware upgrade, contact the Mediana service
center. It may be fail in according with the type of USB memory.
ENTER
ESC
RUN
(ESC) and then press (Enter).
5) The device will display the firmware update screen as shown below figure 6-4.
6) The firmware upgrades by it self.
7) After completion of upgrade, the device default setting at [MENU System Setup
Default Setting] set Yes.
Chapter 7. Troubleshooting
1. General
If the device detects an error, it can display an error code. The error codes are listed in the
service manual. If an error code is displayed, write down the code and contact your service
department. Before calling Mediana service center, make sure that the battery is charged
and that all power connections are in place.
2. Error Description
The following errors are generated by YM412i to notify the user to take the necessary
response. When the following errors occur, Warning Beep makes a sound.
This message with warning beep appears when the printer cover is not close or paper is not
supply. Check the printer cover and/or supply the paper.
This message with warning beep appears when patient ID is not entered at [MENU
System Setup Patient Data Entry Pat. ID Check] set Yes, Input the patient ID or
[MENU System Setup Patient Data Entry Pat. ID Check] set No.
This message with warning beep appears when the birthday is not entered or is out of the
realistic range (month: 1~12, day: 1~31). Check the date and then, input again.
This message with warning beep appears when the date is not entered or is out of the
realistic range (month: 1~12, day: 1~31). Check the date and then, input again.
This message with warning beep appears when the time is not entered or is out of the
realistic range (min: 1~59, hour: 1(0)~12(24)). Check the time and then, input again.
6) Critical error
This message with warning beep appears when the device occur the critical problem. After
that, the device automatically shut down. After a while, turn on.
if problem persists, contact qualified service personnel or Mediana service center.
This message with warning beep appears when the analog signal saturate.
After that, the device automatically adjusted.
This message with warning beep appears when the password is not accurate. Check the
password and then, try again.
This message with warning beep appears when patient ID is not entered and press COPY
button at [MENU System Setup Patient Data Entry Pat. ID Check] set Yes. Input
the patient ID or [MENU System Setup Patient Data Entry Pat. ID Check] set No.
This message with warning beep appears when press the COPY button at manual mode.
This message with warning beep appears when press the copy button at [MENU
Automatic Mode No. of copy] set 0. [MENU Automatic Mode No. of copy] set 1~9.
This message with warning beep appears when patient ID is not entered and press SAVE
button at [MENU System Setup Patient Data Entry Pat. ID Check] set Yes. Input
the patient ID or [MENU System Setup Patient Data Entry Pat. ID Check] set No.
This message with warning beep appears when ECG is not measured, press the SAVE
button.
This message with warning beep appears when ECG is not measured, press the COPY
button.
This message appears with warning beep when the battery is discharge. When warning
message Battery Low appears, all keys are not operation. After that, the device
automatically shut down. AC power cord shall be connected and then battery shall be
charged.
This message appears with warning beep when the memory is full. If select Yes, [Delete
Data and Save] message appears and the No.1 data delete and the new data save. If select
No, data is not save.
y This message appears with warning beep when USB memory does not insert or
recognize. Check the USB memory status.
y This message appears with warning beep when executable file version of firmware same
the firmware version now in use. And this message appears in case of executable file of
the different ECG device.
Chapter 8. Specification
Display
Type 103mm(W) X 77.22mm(H) STN mono LCD
Resolution 320 X 240 dots
Computerized Electrocardiograph
Basic - 100 ECGs (typical)
ECG Storage
Option 5000 cases in SD Card (1GB)
Pre-acquisition Provides 10s of instantaneous ECG acquisition
AC differential: 5mV
Dynamic Range
DC offset: 300mV
Sampling Rate 500Hz
Frequency Response 0.05 to 150Hz
Common Mode
100dB
Rejection
Input Impedance > 50
Patient Leakage
< 10
Current
Communication PC communication with RS232 interface and LAN
Firmware Upload Use the USB memory stick
AC: 50/60Hz
Low Pass Filter: 40, 100, 150Hz
Filter
High Pass Filter: 0.05, 0.5Hz
Muscle Filter
Writer
Type Thermal dot array
Speeds 5, 10, 25, 50mm/sec
Numbers of Traces 3, 6 or 12 user-selectable
Sensitivity/Gain 5, 10, 20mm/mV
Speed Accuracy 5%
Amplitude Accuracy 5%
Paper Type/Size Thermal Roll, 110mm X 30m
Electrical
Power Supply AC or Battery operation
AC Input 100-240VAC 50/60Hz, 70VA
Fuses Qty. 2, 250Vac T6.3AL, IEC(5x20mm)
12V 3.8Ah, Rechargeable Nickel Metal Hydride Cylindrical
Battery Type
Cell
150 basic reports (Auto Mode) or 5hours continuous
Battery Capacity
operation (without printing)
Battery Charge Time Approximately 6hours from total discharge
Physical
Dimension 351 X 268.5 X 63 (W x L x H) mm
Weight 2.7Kg (including battery) without paper
Environmental
Temperature range 10-45
Operating Conditions Humidity range 20%~95%(non-condensing)
Atmosphere Pressure: 700 to 1060 hPa
Temperature range -20~60
Storage/Transportation
Humidity range 10%~95%(non-condensing)
Condition
Atmosphere Pressure: 500 to 1060 hPa
Compliance
Classification Class I, Internally powered
Type of protection Type CF with defibrillation protection
Mode of operation Continuous
Degree of protection IPX 0
General 93/42/EEC Directives for medical devices
ISO9001:2000 Quality Management Systems -
Requirements
ISO13485:2003 Medical devices - Quality management
systems - Requirements regulatory purposes
ISO14971:2000 Medical devices - Application of risk
management to medical devices
Manufacturers Declaration
Warning: For best product performance and measurement accuracy, use only
accessories supplied or recommended by manufacturer. Use accessories
according to the manufacturers directions for use and your facilitys
standards. The use of accessories and cables other than those specified may
result in increased emission and/or decreased immunity of the YM412i
electrocardiograph.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.