Ecg Mediana Ym412i Service Manual

YM412i
ELECTROCARDIOGRAPH
Service Manual
YM412i
Service 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
YM412i Service Manual
Part Number-Revision Number: L05232-00
Printed in Korea
Copyright 2006-2007 Mediana Co., Ltd. All rights reserved.
Notice
This document contains proprietary information that is protected by copyright. All Rights
Reserved. Reproduction, adaptation or translation without prior written permission is prohibited,
except as allowed under the copyright laws.
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 2. Introduction .............................................................................................. 13
1. Device description.................................................................................................. 14
2. Standard Accessories ............................................................................................ 16
3. Contacting a Mediana Service Center .................................................................. 17
Chapter 3. Basic Care and Maintenance .................................................................. 19
1. Description .............................................................................................................. 20
2. Cleaning................................................................................................................... 20
3. Replacing Printer Paper ......................................................................................... 22
4. Battery maintenance and care............................................................................... 23
5. Firmware Upgrade .................................................................................................. 24
6. Cardiograph and Accessory Disposal .................................................................. 24
Chapter 4. Performance Verification and Safety Tests............................................ 25
1. Description .............................................................................................................. 26
2. Test Equipment ....................................................................................................... 26
3. Performance Verification Tests ............................................................................. 26
4. Safety Test............................................................................................................... 31
Chapter 5. Troubleshooting ....................................................................................... 35
1. Description .............................................................................................................. 36
2. Service Technicians ............................................................................................... 36
3. Replacement Support............................................................................................. 36
4. Getting Replacement Parts .................................................................................... 36
5. Troubleshooting Topics ......................................................................................... 36
6. Battery and AC Power ............................................................................................ 38
7. Display ..................................................................................................................... 40
8. Button ...................................................................................................................... 41
9. Beep ......................................................................................................................... 41
10. Printer .................................................................................................................... 42

11. Others .................................................................................................................... 43
Chapter 6. Disassembly Guide .................................................................................. 45
1. Description .............................................................................................................. 46
2. How to Use Disassembly Guide ............................................................................ 47
3. Disassembly Flow Chart ........................................................................................ 47
4. Disassembling Cases............................................................................................. 50
5. Opening the device................................................................................................. 50
6. Lower Case Disassembly....................................................................................... 51
7. Upper Case Disassembly....................................................................................... 57
8. Specification of cables and connectors ............................................................... 60
Chapter 7. Parts List................................................................................................... 65
1. Description .............................................................................................................. 66
Chapter 8. Packing ..................................................................................................... 69
1. Description .............................................................................................................. 70
2. Standard Carton Box Packing ............................................................................... 70
3. Repacking................................................................................................................ 70
Chapter 9. Specifications........................................................................................... 71
Chapter 10. Functional Description .......................................................................... 75
1. Description .............................................................................................................. 76
2. System Overview .................................................................................................... 76
3. Hardware Functional View ..................................................................................... 76
Figures
Figure 2-1. Top Panel...
15
Figure 2-2. Rear Panel.
15
Figure 2-3. Right Panel
15
Figure 3-1. Cleaning the printer head..
21
Figure 3-2. Changing Printer Paper..
22
Figure 3-3. Firmware upgrading Screen.
24
Figure 4-1. Maintenance Menu Screen...............................................................................
29
Figure 6-1. Disassembly Flow Chart
47
Figure 6-2. Upper Case Disassembly..
48
Figure 6-3. Lower Case Disassembly.
49
Figure 6-4 Detach the Upper and Lower case..
50
Figure 6-5 Battery Disassembly
51
Figure 6-6 Thermal Printer Disassembly
52
Figure 6-7 Main Board Disassembly
53
Figure 6-8 Fuses replacement 53

Figure 6-9 Power Module Disassembly..
54
Figure 6-10 Replacing the CPU Module..
55
Figure 6-11. Keypad Disassembly
57
Figure 6-12. LCD and STN-SUB PCB Disassembly.
58
Figure 7-1. YM412i Parts.
66
Figure 10-1. Block Diagram of Entire instrument.
76
Figure 10-2. Power System Block Diagram
77
Figure 10-3. DC Power Supply Block Diagram.
78
Figure 10-4. Main CPU Module Block Diagram.
79
Figure 10-5. RTC Power Interface Block Diagram
79
Figure 10-6. Display Interface Block Diagram..
80
Figure 10-7. Keypad Interface Block Diagram..
80
Figure 10-8. Thermal Printer Interface Block Diagram
81
Figure 10-9. Communication Interface Block Diagram..
81
Figure 10-10. Analog Signal Acquisition Interface Block Diagram.
82
Tables
Table 2-1. List of Components.
16
Table 4-1 Top panel indicators for power source
27
Table 4-2 Battery Charging Status Indications
27
Table 4-3. Earth Leakage Current Values..
31
Table 4-4. Patient Leakage Current Values..
32
Table 4-5. Patient Leakage Current Values-Mains Voltage on Applied Part.
32
Table 4-6. Allowable Leakage Current
33
Table 5-1 Troubleshooting Topics...
37
Table 5-2 Battery and AC Power Troubleshooting.
38
Table 5-3 Display Troubleshooting.
40
Table 5-4 Button Troubleshooting..
41
Table 5-5 Beep Troubleshooting..
41
Table 5-6 Printer Troubleshooting..
42
Table 5-7 Others...
43
Table 6-1. Part Descriptions Lower Case Assembly...
56
Table 6-2. Part Descriptions Upper Case Assembly...
59
Table 6-3. Main PCB to Keypad PCB Cable..
60
Table 6-4. Main PCB to STN-SUB PCB Data Cable.
61
Table 6-5. STN SUB PCB to LCD Back Light Cable
61
Table 6-6. Main PCB to Printer Unit Head Cable.
62
Table 6-7. Main PCB to Printer Unit Motor Film Cable..
62
Table 6-8. Main PCB to Printer Unit Motor Film Cable..
62
Table 6-9. Main PCB to SMPS Module Cable
63
Table 6-10. SMPS to Battery Cable.
63
Table 6-11. SMPS to Battery Cable.
63
Table 7-1. YM412i Part List..
67
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Information
Chapter 1. Information
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.
The product complies with the electromagnetic immunity requirements of standard IEC
60601-1-2/EN 60601-1-2 Electromagnetic Compatibility Medical Electrical Equipment.
The radio-interference emitted by this device is within the limits specified in

CISPR11/EN55011, class B.
This manual contains service information; operating instructions are provided in the user
manual of the instrument.
This manual is for users who handle preventive maintenance, periodic operational checks,
and basic troubleshooting for YM412i cardiograph.
Before attempting to service the cardiographs, you must review the YM412i operators manual.
y
Mediana considers itself responsible for the effects on safety, reliability, and performance of
the equipment, only if;
assembly operations, extensions, readjustments, modifications, or repairs are carried out by

Mediana or by persons authorized by Mediana,
the electrical installation of the relevant room complies with the applicable national and local
requirement, and
the instrument is used in accordance with the instructions for use.
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.
10
Information
2. Safety Information
It is strongly recommended that the user first review this document thoroughly before operating
the system.
Warning: When operating the cardiograph on AC power, ensure that the
cardiograph and all other electrical equipment connected to or near the patient
are effectively grounded.
Warning: Use only grounded power cords (three-wire power cords with
grounded plugs) and grounded electrical outlets.
Warning: If a safe ground connection is not ensured, operate the cardiograph

on battery power only.
Warning: Do not open or close the equipment on your own.
Warning: Periodically inspect the patient cable, lead wires, and AC power cord
for any worn or cracked insulation.
Warning: Keep the patient cable away from power cords and ay other electrical
equipment. Failure to do so can result in AC power line frequency interference
on the ECG trace.
Warning: The Mediana patient cable (supplied with the cardiograph) is an

integral part of the cardiograph safety features. Use of any other patient cable
may
compromise
defibrillation
protection
and
degrade
cardiograph
performance.
Warning: Only qualified personnel may service the cardiograph or may open
the cardiograph housing to access internal cardiograph components. Do not
open any covers on the cardiograph. All internal components must be serviced
by qualified personnel.
Warning: Do not use this cardiograph near flammable anesthetics. It is not

intended for use in explosive environments or in operating rooms.
11
Information
Warning: Do not touch the patient, patient cable, or cardiograph during

defibrillation. Death or injury may occur from the electrical shock delivered by
the defibrillator.
Caution: During repairs/service interventions, observe the protective measures

against damage due to ESD (electrostatic discharge).
Caution: Only use patient electrodes that are approved by Mediana. The use of
non-approved patient electrodes may degrade cardiograph performance.
Caution: For continued protection against risk of fire, replace only with same
type and rating of fuse.
Caution: If internal battery cable has been disconnected, pay particular

attention to polarity of the cable before reattaching. If battery cable polarity is
reversed, it is likely that circuit damage will occur.
12
Introduction
Chapter 2. Introduction
13
Introduction
1. Device description
The purpose and function of YM412i product is to diagnose electrocardiogram, which is
designed for easy operation. ECG waveforms are displayed on the graphic LCD, and the
displayed waveforms can be printed with the built-in thermal printer. Also the YM412i product
can be connected to a personal computer based Cardiology Information System to store
information on patients and ECG data.
14
Introduction
The section shows top, side and rear views of the YM412i. For additional details, see the
Operators manual.
Thermal
Printer
Graphic
LCD
Keypad
Figure 2-1. Top Panel
Figure 2-2. Rear Panel
Figure 2-3. Right Panel
15
Introduction
2. Standard Accessories
Table 2-1. List of Components
YM412i Main 1EA
Clamp Electrodes 1Pack
Chest Electrodes 1Pack
Patient Cable 1EA
Power Cable 1EA
Thermal Paper 1Pack
Operators manual 1EA

Service manual 1EA
Serial Cable 1EA
Ground Cable 1EA
NOTE: The above pictures vary from the original in some points.
16
Introduction
3. Contacting a Mediana Service Center

The Mediana Service Center can assist with product troubleshooting and provide
technical expertise to help with any issue with the YM412i cardiograph or any of its
accessories.
TEL
+82-33-742-5400
FAX
+82-33-742-5618
17
Introduction
18
Basic Care and Maintenance
Chapter 3. Basic Care and Maintenance
19
1. Description
This chapter contains information on basic cardiograph care and periodic maintenance. If
further technical assistance is required, contact the Mediana Service Center. Basic cleaning
and maintenance guidelines are also included in the Cleaning and Maintenance chapter of the
YM412i Operators manual.
2. Cleaning
Warning: Do not spray, pour or spill liquid materials on the product,
accessories, connectors, switches or cases. And do not wash the product or
the accessories with soluble or invasive liquid.
For wash the product, wipe the surface lightly with a soft cloth, soaked with a general-use or
non-invasive detergent. While washing, make it sure that any liquid material should not
infiltrate into connectors or covers. Equivalent attention should be paid to cables and
accessories.
1) Cleaning the Cardiograph
y
When cleaning the equipment, wipe it with sponge, soft cloth or something like that wetted
with soapy water and never use the detergent using alcohol, ammonia or acetone as main
ingredients.
When cleaning the equipment, pay special attention so that cleaning liquid or something
like that may not soak into the inside of equipment.
Caution: When cleaning, avoid the lead wire connectors and patient cable
connectors.
Caution: Do not use strong solvents or abrasive cleaning materials.
Caution: Do not spill liquids on the surface of the cardiograph.
Caution: Do not use any of the following to clean the cardiograph:

- Acetone, Iodine-based cleaners, Phenol-based cleaners, Ethylene oxide
20
sterilization, Chlorine bleach, Ammonia-based cleaners
2) Cleaning the Patient Cable and Electrodes

Caution: Do not use isopropyl alcohol.
Caution: Do not use abrasive materials.
Caution: Do not wet the connectors.
To clean the patient cable and lead wires

y
Dampen a soft cloth with soapy water or with one of the disinfectants or cleaning agents list
below. Clean patient cable and lead wires with any of the following:
- Cidex Ortho Phthaladehyde
- Cetylcide
- Vesphene 2 Aqueous Phenolic Germicidal Agent
Wring excess moisture from the cloth before cleaning.
3) Cleaning the Printer Head

- Unclean printer head can be cause of reducing print quality.
- Open the printer cover and then wipe it softly without rubbing it too hard by wetting swab with
90% alcohol.
- After cleaning, dry printer head sufficiently and then use it.
Figure 3-1. Cleaning the printer head
21
3. Replacing Printer Paper

Paper should be replaced in case red lines appear on paper when the ECG report is printed.
Only use Mediana replacement printer paper.
1) Open the cover of a printer to remove the finished paper. Be careful not to throw away the
paper guide inserted in the roll of paper, which is to be reused.
2) Insert the paper guide into a new roll of paper to place the roll at the center of the printer.
3) Unroll the paper slightly to put it on the printer roller, close the cover and test if the printer
works normally.
Figure 3-2. Changing Printer Paper
22
4. Battery maintenance and care

Charging the battery will be required if the YM412i product has not been used for a long time.
Connect the device to the AC power source for charging the battery.
Battery life varies depending on frequency of use and maintenance. For improved battery life,
keep the cardiograph plugged in when not in use. If the battery has been fully charged and
requires recharging after a few ECGs, consider replacing it.
For optimal battery performance:
y
Only use Mediana Ni-MH battery.
Keep the cardiograph plugged in when not in use.
Caution: The battery should be removed form the unit and placed in storage if
the cardiograph will not be used for more than 2 months. To replace or remove
the battery, refer to Chapter 6. Disassemble Guide.
Caution: Repeated undercharging of the battery will damage and reduce

battery life.
Caution: Follow local government ordinances and recycling instructions

regarding disposal or recycling of device components, including batteries.
NOTE: The capacity of a battery will be decreased if the YM412i product has not
been used for a long time without charging it. It takes around 6 hours to charge a
battery, and it is necessary to discharge and charge a battery regularly for recovery to
the normal battery capacity. Mediana recommends that the Ni-MH battery for YM412i
product should be replaced every two years. Please refer to the Chapter 6.
Disassembly Guide for more information.
23
5. Firmware Upgrade
This section is for the purpose for reloading firmware in the device when the possibility of
corrupted firmware exists, or upgrading firmware with a new system version. The USB
Memory required for firmware upgrade.
Caution: When a new firmware uploading is completed, the device is set to the
default.
Caution: If any problem during Firmware upgrade, contact the Mediana service
center. It may be fail in according with the type of USB memory.
1) Turn the device off.

2) The new firmware (Folder name: Y412update) inserted in the USB memory.
3) Connect the USB memory and device.
4) After turn on the YM412i, booting screen appears. Before finish the booting screen, press
ENTER
ESC
(ESC) and then press
RUN
(Enter).
5) The device will display the firmware update screen as shown below figure 3-3.
6) The firmware upgrades by it self.
Figure 3-3. Firmware upgrading Screen

7) After completion of upgrade, turn the device off. After a few seconds, turn on again.
6. Cardiograph and Accessory Disposal

When the cardiograph has reached the end of its product life, dispose if it according to local
ordinance. When any of the cardiograph accessories reach the end of their product life,
dispose of these items in accordance with local ordinances.
24
Performance Verification and Safety Tests
Chapter 4. Performance Verification and Safety Tests
25
1. Description
This chapter describes the tests and inspections required to verify performance of the YM412i
following a service event.
The performance verification tests verify proper operation of the YM412i following a service
event. The level of testing required corresponds to the type of service performed.
2. Test Equipment
The following test equipment is required to perform the complete set of Performance
Verification tests:
y
ECG Simulator
Digital Multi Meter
Electrical Safety Tester
ECG patient cable
3. Performance Verification Tests

1) Visual Inspection
1. Inspect the cardiograph external surfaces for the following:
y Worn or damaged power cord
y Loose or missing hardware
y Mechanical damage
y Evidence of liquid spill
y Worn printer drive gear
y Worn printer roller
y Corroded or damaged reusable electrodes
y Damaged patient leads
y Dirt or paper residue on the thermal print head
y Frayed or damaged wiring
y Visible LCD display damage
2. Replace any damaged or missing items.
3. Clean the patient cable as necessary. See Chapter.3 Basic care and maintenance.
2) Power on test
To process a completed power in test, you must completely reboot the cardiograph.
1.
2.
3.
4.
5.
6.
7.
26
Connect the cardiograph to AC power source using proper power cord.

Verify AC IN( ) and Battery( ) in indicators is lit.
Press Power button, and then verify that the cardiograph is turned on.
Verify Power ON( ) in indicator is lit.
After the cardiograph operates in normal mode, disconnect the power cord.
Verify AC IN( ), Battery( ) indicator is off, and Power ON( ) indicator is lit.
Press Power button, and then verify that the cardiograph is turned off.
Table 4-1 Top panel indicators for power source

Power Connections
Top panel Indicator illuminate
AC IN
Power OFF
Fully charged battery
AC IN
Power ON
Fully charged battery
AC OUT
Power ON
Battery operation
3) Charging Battery
Follow the below instruction for full battery charge.
1. Connect the electric cord to the AC power source of the device, and then connect the
electric cord to the external power supply.
2. When the AC power cord is plugged in, the battery automatically begins to charge. Fully
charged battery will not do change. The charging battery can be automatically charged by
inputting AC power; yellow LED on
flashes while charging is under progress, and then
the flashing stops when charging is completed.
3. Charge the battery for more than 6 hours. Regular full charge and discharge is required for
recovery to the normal capacity.
4. Follow the below Battery Functional Test to check the full charge.
Table 4-2 Battery Charging Status Indications
Battery conditions
Battery charging status indicator(
Full charged
On
Charging
Flashing
Operation
Off
27
4) Battery Functional Test

Basically this YM412i product can be operated for more than 90 minutes at the temperature of
25 on condition that the printer is not to be used. Before testing these functions, the battery
should be fully charged.
Caution: When the battery using more than 6months, will gradually reduce
battery life.
1. Connect ECG simulator to the YM412i product.
2. Adjust the ECG simulator so that the heart rate becomes 60bpm and the amplitude
becomes 1mV.
3. Connect the electric cord to the AC power source of the device, and then connect the
electric cord to the external power supply.
4. Press the Power button on the product and check if the indicator is lit.
5. Check if a signal of the ECG simulator is displayed on the LCD screen.
6. The device should be operated for more than 90 minutes.
7. The device should generate ECG graphs more than 30 times.
8. Check if a message of Battery Low is displayed before the full discharge.
9. Press the Power button to stop operation.
10. If device passes this test, immediately recharge battery.
5) LCD Test
MENU
1.
Maintenance
2. Move shadow box(
) to the Maintenance, and press (ENTER) key to show the
password input window.

3. Input the password 1560, and press (Enter) to show the maintenance window.
28
Figure 4-1. Maintenance Menu Screen

4. To verify or optimize cardiograph LCD state, use the LCD test. Move shadow
) to LCD Test, and press (ENTER) key to display the test screen. If something
box(
is the matter with the LCD, contact qualified service personnel or Mediana service center.
6) Printer Test
MENU
1.
Maintenance
2. Move shadow box(
) to the Maintenance, and press (ENTER) key to show the
password input window.
29
3. Input the password 1560, and press (Enter) to show the maintenance window.
4. The Printer Test is used to verify that the cardiograph printer is able to correctly print the
test page.
5. Use this to verify proper printer performance or when reports appear to have print quality
errors.
6. Move shadow box(
) to Printer Test, and press (ENTER) key to print the printer
test page.
7. If something is the matter with the test page, clean the printer header. The method of
printer cleaning refers to Chapter 3. Basic care and Maintenance.
8. Contact qualified service personnel or Mediana service center. if problem persists after
printer header cleaned.
7) ECG Simulation
1. Connect the YM412i product to the AC power supply.
2. Press the Power button on the product.
3. Connect Mediana ECG cable to ECG cable connector on the cardiographs right panel.
4. Set ECG simulator as follows;
y Heart rate: 60bpm
y Amplitude: 1mV
y Normal sinus rhythm
5. After a few seconds, check if ECG waveforms are displayed on the LCD screen.
6. Select Automatic Mode and then press RUN button to start printing.
7. Verify the following when printing is complete:
y Trace activity for all 12 leads. Noise should measure less than 1mm, with no
baseline wander.
y No gross distortion of complexes or calibration pulses
y Calibration pulse amplitude is correct.
NOTE: Noise may be an artifact of poor connections to the simulator or position of the
cables. If noise appears, check the connectors or adjust the cable drape.
30
4. Safety Test
This section explains tests of the cardiographs electrical safety.
The suggested Safety Analysis Tests refer to the international standard IEC60601-1, Clause 19.
The tests are generally performed with Safety Testers, on most of them, the measuring circuits
according IEC60601-1 are already implemented. The following is a general description of the
tests to be performed.
The tests may be performed under normal ambient conditions of temperature, humidity and
pressure and with line voltage.
Test both Normal and Reverse polarity line connections for each test, and record the worstcase value.
y If a ground reference point is needed for the testing, use the metal grounding stud in the
back of the cardiograph.
y
1) Protective Earth Resistance

This test checks the integrity of the power cord ground wire from the AC plug to the instrument
chassis ground. The current used for this test is less than or equal to 4Volts RMS, 50 to 60Hz,
and 25Amperes.
1. Connect the device AC mains plug to the analyzer recommended by the analyzer
operating instructions.
2. Connect the analyzer resistance input lead to the equipotential terminal on the rear of the
device. Verify that the analyzer indicates 100milliohms or less.
2) Leakage Current - Earth Leakage Current
This test is in compliance with IEC60601-1 earth leakage current. The applied voltage for
IEC60601-1 the voltage is 264V AC, 50-60Hz.
1. Connect the device AC plug to the electrical safety analyzer as recommended by the
analyzer operating instructions.
2. Perform the test as recommended by analyzer operating instructions.
3. Earth leakage current is measured under various condition of the AC mains and protective
earth conductor. For each condition, the measured leakage current must not exceed that
indicated in Table 4-1.
Table 4-3. Earth Leakage Current Values
Condition
Allowable Leakage Current (microamps)
Normal Condition
500
Single Fault Condition
1000
3) Leakage Current - Patient Leakage Current

This test is performed according to IEC60601-1 Standards on the Class I CF typed devices.
Patient leakage current in this test is measured from any individual patient connection to earth
(power ground).
31
1. Set the electrical safety analyzer as recommended by the electrical analyzers operating
instructions.
2. Connect the devices AC mains power cord to the electrical analyzer as recommended by
the electrical analyzers operation instructions.
3. Connect ECG test cable between ECG connector on the device and appropriate input
connector on analyzer. Turn on the YM412i device.
5. Patient leakage current is measured with normal and reverse mains polarity. For each
condition, the measured leakage current must not exceed that indicated in Table4-2.
Table 4-4. Patient Leakage Current Values
Condition
Normal Condition
10
50
4) Leakage Current Patient Leakage Current (Mains Voltage on the Applied Part)
This test is performed according to IEC60601-1 Standards on the Class I CF typed devices. In
this test, 110% of mains voltage is applied between each patient connection and earth (power
ground). Patient leakage current is then measured from any individual patient connection to
earth.
instructions.
3. Connect ECG test cable between ECG connector on the device and appropriate input
connector on analyzer. Turn on the YM412i device.
5. Patient leakage current is measured with normal and reverse mains polarity. For each
condition, the measured leakage current must not exceed that indicated in Table4-3.
Table 4-5. Patient Leakage Current Values-Mains Voltage on Applied Part
Condition
Normal polarity (Single Fault Condition)
50
Reverse polarity (Single Fault Condition

Reverse Mains Voltage)
32
50
5) Patient Auxiliary Current

This test is performed according to IEC60601-1 Standards on the Class I CF typed devices.
The applied voltage for IEC60601-1 the voltage is 264V, 50-60Hz. Patient auxiliary current is
measured between each ECG test lead.
instructions.
Table 4-6. Allowable Leakage Current
Condition
Normal Condition
10
50
33
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34
Troubleshooting
Chapter 5. Troubleshooting
35
Troubleshooting
1. Description
This chapter suggests troubleshooting tips for problems with YM412i. The below tables will
show the possible problems of the device and the recommendable troubleshooting procedures.
2. Service Technicians
Only technically qualified service operators can carry out disassembly & adjustment of a
device and removal & replacement of parts. In case a qualified service operator is not available,
contact the Mediana Service Center.
3. Replacement Support
The replaceable parts of this product are PCBs, main assemblies and some parts. If a PCB is
considered to be defect, replace it with a new one according to the Chapter 6 Disassembly
Guide. Check if the error is corrected after replacement and carry out all functional tests. In
case the error still happens, replace the new PCB with the original one and find another
solution as instructed in this chapter.
4. Getting Replacement Parts

Mediana provides technical support and replacement parts. To get a replacement part, users
can contact the Mediana Service Center, referring to the Chapter 5 Replacement Parts for
part names and numbers.
5. Troubleshooting Topics
The following table lists all of the Troubleshooting topics included in this chapter.
NOTE: The troubleshooting tips in this chapter cover the main troubles that users
possibly encounter. For other problems, not included in these troubleshooting tips,
contact the Mediana Service Center.
Warning: Electrical shock hazard. Disconnect a power cord from YM412i before
attempting to open or disassemble YM412i.
36
Troubleshooting
Table 5-1 Troubleshooting Topics

Topic
Symptom
1. When AC power cord is connected to the device, AC indicator on the
Batteries
and
AC Power
front panel is not lit.

2. Power is not on when pressing the POWER button in condition the
external AC power line is connected to the device.
3. The device does not operate when disconnected from AC power.
4. Battery does not charge.
1. Screen is totally black color or white color (no data is visible) when the
power is turned on.
Display
2. Data (signal & text) is not shown even though the screen is normal.
3. Backlight is not activated while data is displayed on the screen.
4. Display values are missing or erratic.
Button
Beep
1. Buttons do not respond.

2. Some of buttons do not work tough the power is turned on.
1. Audible beep does no sound.
1. Printer does not response even though printing related buttons are
Printer
pressed.
2. Printer generates empty paper even in case the printer motor works
and the printing paper is loaded.
1. One lead signal or more come out in straight lines or too much noise is
Other
generated.
2. One leads signal or more come out in straight lines or too much noise is
generated.
37
Troubleshooting
6. Battery and AC Power

The following table describes common problems with batteries and AC power. If the action
requires replacement of the components, refer to [Chapter 6. Disassembly Guide].
Table 5-2 Battery and AC Power Troubleshooting
Symptom
Solution
1-1 Ensure power cord is plugged into the appropriate AC outlet
of voltage and frequency.
1-2 Replace the AC fuse.
1. When AC power cord is 1-3 Check the main cable and ensure that it is connected to the
connected to the device, AC main board and the power module.
indicator on the front panel 1-4 If indicator is not lit, replace the main cable.
is not lit.
1-5 If the problem persists, replace the power module.

1-6 If the problem persists, ensure the keypad cable is
connected to the keypad assembly and the main board. If
connection is good, replace the keypad.
2-1 Ensure power cord is plugged into the appropriate AC outlet
of voltage and frequency.
2. Power is not on when

pressing
button
the
in
POWER
condition
the
external AC power line is

connected to the device.
2-2 Ensure AC power indicator is lit. If indicator is not lit, replace

the power module.
2-3 Replace the AC fuse.
2-4 Check the main cable and ensure that it is connected to the
main board and the power module.
2-5 Ensure the keypad is connected to the main board. If
2-6 If the problem persists, replace the main board.
3-1 The battery may be discharged. To recharge the battery,
connect a power cord to AC mains over 6hours.
3. The device does not

operate when disconnected
from AC power.
3-2 Check the main cable and ensure that it is connected to the
main board and the power module.
3-3 The battery may be overheated. After it has dropped,
operate the device.
3-4 If the problem persists, replace the battery.
3-5 If the problem persists, replace the main board.
38
Troubleshooting
4-1 Ensure the keypad is connected to the main board. If

4-2 If the battery fails to hold a charge, replace the battery.
4. Battery does not charge.
4-3 Verify the AC IN LED is lit, while on AC. While charging

battery, the Battery LED is flashed until battery charging is
completed. When the battery charging is completed, the Battery
LED is lit continuously. Replace the power module if the LEDs
are not lit.
39
Troubleshooting
7. Display
The followings are symptoms of problems relating to non-functioning displays, and
recommended action. If the action requires replacement of a PCB assembly or module, refer to
Chapter 6.
Table 5-3 Display Troubleshooting
Symptom
Solution
1-1 Check the backlight cable and the data cable are connected
to the STN-SUB PCB.
1. Screen is totally black or 1-2 Check the STN-SUB PCB connector is connected to the
white
color
(no
data
is main PCB
visible) when the power is 1-3 If problem persists, replace the STN-SUB PCB.
turned on.
1-4 If problem persists, replace the LCD module.

1-5 If problem persists, replace the CPU module.
1-6 If problem persists, replace the main board.
to the STN-SUB PCB.
2. Data (signal & text) is not

shown
even
though
the
screen is normal.
2-2 Check the STN-SUB PCB connector is connected to the

main PCB
2-3 If problem persists, replace the STN-SUB PCB.
2-4 If problem persists, replace the CPU module.
to the STN-SUB PCB.
3. Backlight is not activated 3-2 Check the STN-SUB PCB connector is connected to the
while data is displayed on main PCB
the screen.
3-3 Replace the STN-SUB PCB if problem persists.

3-4 Replace the LCD module if problem persists.
3-5 Replace the main PCB if problem persists.
4-1 If the patient cables are connected, ensure that the cables
are properly connected.
4.
Display
values
missing or erratic.
are
4-2 Verify position of the leadwire, re-setting the filter.

4-3 AC supply may be wrong, operate the battery and check.
4-4 If problem persists, replace the patient cable.
40
Troubleshooting
8. Button
The following is a symptom of problems and recommended actions relating to buttons. If the
action requires replacement of a PCB assembly, refer to Chapter 6.
Table 5-4 Button Troubleshooting
Symptom
Solution
1-1 Check the keypad is properly connected to the main board.
1-2 Check the cable between main board and the keypad PCB.
1. Buttons do not respond.
1-3 If the cable abnormal, replace the cable.

1-4 If problem persists, replace the keypad PCB.
2-1 Check the keypad is properly connected to the main PCB.
2. Some of buttons do not 2-2 Check the cable between main board and the keypad PCB.
work tough the power is 2-3 If the cable abnormal, replace the cable.
turned on.
2-4 If problem persists, replace the keypad PCB.

2-5 If problem persists, replace the main PCB.
9. Beep
The following is a symptom of problems and recommended actions relating to beep. If the
Table 5-5 Beep Troubleshooting
Symptom
Solution
1-1 Check beep silence status.
1. Audible beep does no

sound.
1-2 Check beep setting in system setup menu.

1-3 Check the main cable between main board and the power
module.
41
Troubleshooting
10. Printer
The following is a symptom of problems and recommended actions relating to printer. If the
Table 5-6 Printer Troubleshooting
Symptom
Solution
1-1 Open the printer cover and check if the paper is properly
loaded.
1. Printer does not response 1-2 Check the printer related connections are properly secured.
even though printing related 1-3 The printer header may be overheated. After it has dropped,
buttons are pressed.
operate the device.

1-4 If problem persists, replace the printer module.
2. Printer generates empty

paper even in case the
printer motor works and the
printing paper is loaded.
42
2-1 Open the printer cover and check the paper is properly
loaded. (Only one side of paper is effective thus it will not work if
the opposite side is loaded.)
2-2 If problem persists, replace the printer module.
Troubleshooting
11. Others
Table 5-7 Others
Symptom
Solution
1. One lead signal or more 1-1 Check the patient cable is properly connected to the device.
come out in straight lines or 1-2 Check the filters are properly setting.
too
much
noise
is 1-3 If problem persists, replace the patient cable.
generated.
1-4 if problem persists, replace the main board.
2. Leads II and III
2-1 Check LL(or F) and RL(or N) lead wire and electrode.
3. Leads I and III
3-1 Check LA(or L) and RL(or N) lead wire and electrode.
4. Leads I and II
4-1 Check RA(or R) and RL(or N) lead wire and electrode.
5. V1-V6(C1-C6)
5-1 Check V1-V6(C1-C6) and RL(or N) lead wire and electrode.
43
Troubleshooting
44
Disassembly Guide
Chapter 6. Disassembly Guide
45
Disassembly Guide
1. Description
This chapter contains information on removing and replacing the YM412i components.
Caution: Do not operate the YM412i product right after repair or examination.
Operate the device after completing all of the functional tests and safety
inspections described in the Chapter 3. Failure in the functional test may cause
misreading.
The following parts of the YM412i product can be disassembled.

y PCB
y Battery
y Cables
y Printer
y Case
The following tools are used for disassembly.
y
y
y
Screwdriver (manual or automatic)

Needle - Nose Pliers
Torque
Warning: Electrical shock hazard. Be sure to disconnect the main power
supply from the device before disassembling the YM412i product.
Warning: A high-voltage can be generated from the LCD backlight driver. Be

careful when opening the cover.
Caution: In case the internal battery cable is not connected, special attention
should be paid to the polarity of the power supply. If the polarity is reversed,
the circuits may be damaged.
NOTE: To get main replacement parts, contact the head office of Mediana Service
Center.
46
Disassembly Guide
2. How to Use Disassembly Guide

Warning: Before attempting to open or disassemble the electrocardiograph,
disconnect the power cord from the electrocardiograph.
Caution: Observe ESD (electrostatic discharge) precautions when working
within the unit.
To find a replacement part of the YM412i product, follow the step-by-step procedure of the flow
charts described in Figure 6-1, 6-2 and 6-3.
As described in the flow charts, the disassembleable parts are basically sorted into the upper
case assembly part and the lower case assembly part. The main PCB assembly is separated
from the lower case assembly. For the list of replaceable parts, refer to the Chapter 7
Replacement Parts. The disassembly flow charts can be referred for removal or replacement
of abnormal parts and partial assemblies. For more detailed information on disassembly, refer
to the diagrams of the appendix.
3. Disassembly Flow Chart

The below disassembly chart is available only for the YM412i product. And the chart is
prepared for the qualified service operators approved by Mediana, which is composed in direct
manner for troubleshooting.
Figure 6-1. Disassembly Flow Chart
47
Disassembly Guide
Figure 6-2. Upper Case Disassembly
48
Disassembly Guide
Lower Case
Main PCB
Detach the cable

between main PCB
and power module.
Detach
connectors from
PCB
Power Module
Detach the cable

between main PCB
and power module.
Remove screws from

power module
Battery
Remove screws
from battery
bracket
Detach battery
bracket
Printer
Remove screws
from printer
CPU Module
Detach CPU
Module Cap
Remove screws
from PCB.
Remove ground
terminal from
case.
Detach the CPU

Module from Main
PCB
Figure 6-3. Lower Case Disassembly
49
Disassembly Guide
4. Disassembling Cases
This chapter shows the disassembly procedures, through pictures, for replacement of the
assemblies or the parts of the YM412i product that are considered to be defect or damaged.
Some of the explanatory procedures contain pictures of the replacement parts.
5. Opening the device

To open the YM412i release the 4 fastening screws (M3x8) on the underside of the device,
carefully raise the upper shell of the housing, disconnect keypad and LCD cable.
Figure 6-4 Detaching the Upper and Lower case
50
Disassembly Guide
6. Lower Case Disassembly

Main Board, CPU Module, Power Module, Battery, Printer
1) Removing and Replacing the Battery
1. Disconnect the battery connector from the power module.
2. Remove 4 fastening screws (M3x6) from battery bracket.
3. Separate the battery bracket and battery.
4. Insert the new battery into the battery bracket.
Figure 6-5 Battery Disassembly
51
Disassembly Guide
2) Removing and Replacing the Printer

1. Disconnect the printer film cable and motor film cable from the main board.
2. Remove 2 fastening screws (M2.6x8) from lower case.
Figure 6-6 Thermal Printer Disassembly
52
Disassembly Guide
3) Removing and Replacing the Main Board

1. Detach the connection cable between main PCB and power module.
2. Remove 12 fastening screws (CPU module 4 screws: M3x5, Main board 8 screws: M3x6)
from lower case.
Figure 6-7 Main Board Disassembly

4) Removing and Replacing the Fuse
1. Remove 2 AC main fuses (250V/6.3A) out of the socket if required.
2. Replace new fuse.
Figure 6-8 Fuses replacement
53
Disassembly Guide
5) Removing and Replacing the Power Module

1. Detach the connection cable between main PCB and power module.
2. Remove the GND terminal from lower case.
3. Remove 5 fastening screws (M3x6) from lower case and detach the power module.
Figure 6-9 Power Module Disassembly
54
Disassembly Guide
6) Replacing the CPU Module

1. Remove 4 fastening screws (M3x5) from lower case.
2. Detach the CPU module cap from main board.
3. Remove 4 supports male type and 4 supports female type
4. Detach the CPU module from main board.
Figure 6-10 Replacing the CPU Module
55
Disassembly Guide
Table 6-1. Part Descriptions Lower Case Assembly
56
Part Codes
Descriptions
Qty
E00000-00
Battery
M05210-00
Battery Bracket
E50000-00
Printer
P05201-00
Main Board
P05202-00
CPU Module
M05211-00
CPU Module Cap
E41101-00
Power Module
Screw
23
Disassembly Guide
7. Upper Case Disassembly

Keypad PCB, LCD, STN-SUB PCB
1) Removing and Replacing the Keypad PCB
1. Remove 4 fastening screws (M3x6) from upper case.
2. Disconnect the cable between keypad PCB and main board.
Figure 6-11. Keypad Disassembly
57
Disassembly Guide
2) Removing and Replacing the LCD and STN-SUB PCB

1. Remove 8 fastening screws (M3x6) from upper case.
2. Disconnect the cable between LCD and STN-SUB PCB.
3. Disconnect the cable between STN-SUB PCB and main board.
Figure 6-12. LCD and STN-SUB PCB Disassembly
58
Disassembly Guide
Table 6-2. Part Descriptions Upper Case Assembly

Part Codes
Descriptions
Qty
P05203-00
Keypad PCB
H05212-00
Cable between keypad PCB and main board
E20001-00
LCD
P05204-00
STN-SUB PCB
H05211-00
Cable between STN-SUB PCB and main board
Screw
12
59
Disassembly Guide
8. Specification of cables and connectors

The tables in this section describe and show the specification of all cables in the YM412i. This
table will be useful when reassembling and debugging.
Table 6-3. Main PCB to Keypad PCB Cable
60
Main PCB
Keypad PCB
J5
J9
Color
Description
Red
Key column 3
Gray
Key row3
Gray
Key column 2
Gray
Key row2
Gray
Key column 1
Green
Key row1
Gray
Key column 0
Gray
Key row0
Gray
GND
10
10
Gray
GND
11
11
Green
Power ON/OFF Key
12
12
Gray
SMPS Standby power
13
13
Gray
AC power check indicator
14
14
Gray
GND
15
15
Gray
Battery charge indicator
16
16
Green
Power ON Indicator
Disassembly Guide
Table 6-4. Main PCB to STN-SUB PCB Data Cable

Main PCB
STN SUB PCB
J10
J13
Color
Description
Red
+5V VDD
Gray
Back light unit Power
Gray
GND
Gray
GND
Gray
VSYNC
Green
Video Data 0
Gray
VDE
Gray
Video Data 1
Gray
HSYNC
10
10
Gray
Video Data 2
11
11
Green
VCLK
12
12
Gray
Video Data 3
13
13
Gray
LCD Enable
14
14
Gray
GND
15
15
Gray
GND
16
16
Green
Contrast control
17
17
Gray
-20V STN
18
18
Gray
GND
19
19
Gray
GND
20
20
Gray
GND
Table 6-5. STN SUB PCB to LCD Back Light Cable

STN SUB PCB
LCD BLU
J2
LCD
GND
N.C
N.C
OUT
Description
61
Disassembly Guide
Table 6-6. Main PCB to Printer Unit Head Cable

Main PCB
Printer unit
PJ5
Head
1, 21,22
1, 21,22
11V Header power
NC
Header data Latch signal.
Header CLK
5V VDD
Strobe signal 1
7,8
7,8
Strobe signal 2
Header thermistor
10,11,12,13,14,15
10,11,12,13,14,15
GND
16,17
16,17
Strobe signal 2
18,19
18,19
Strobe signal 2
20
20
Data
Description
Table 6-7. Main PCB to Printer Unit Motor Film Cable

Main PCB
Printer unit
PJ2
Motor
Phase A
Phase negative A
Phase B
Phase negative B
Description
Table 6-8. Main PCB to Printer Unit Motor Film Cable
62
Main PCB
Printer unit
PJ2
Paper Sensor
Phase A
Bias
Sensor out
GND
Description
Disassembly Guide
Table 6-9. Main PCB to SMPS Module Cable

Main PCB
SMPS
WJ2
CJ3
Color
Description
Red
BATT Level Signal
Gray
Battery charging status signal
Gray
Ac check signal
Gray
Main DC/DC ON/OFF Signal
Gray
GND
Green
SMPS Standby 16V
Gray
STN Negative Power
Gray
STN Negative Power
Gray
GND
10
10
Gray
GND
11
11
Green
Thermal Printer Header VCC
12
12
Gray
Thermal Printer Header VCC
13
13
Gray
GND
14
14
Gray
GND
15
15
Gray
Thermal printer Motor VCC
16
16
Green
Thermal printer Motor VCC
17
17
Gray
GND
18
18
Gray
GND
19
19
Gray
5V
20
20
Gray
5V
Table 6-10. SMPS to Battery Cable

SMPS
Battery
CN2
Color
Description
Red
Battery( +)
Blue
Thermistor
Black
Battery(-)
Table 6-11. SMPS to Battery Cable

SMPS
GND
Color
Description
Power inlet earth
GND Terminal
Green & Yellow
GND
terminal
63
Disassembly Guide
This Page is intentionally left blank.
64
Parts List
Chapter 7. Parts List
65
Part List
1. Description
This chapter provides information on ordering replacement parts, supplies, and accessories for the YM412i cardiograph. To order replacement
parts, contact Mediana Service Center.
Figure 7-1. YM412i Parts
66
Parts List
Table 7-1. YM412i Part List

No.
Part Codes
Description
L05203-00
Keypad Overlay
L05202-00
LCD Overlay
C05250-00
Thermal Printer Cover
E60000-00
Thermal Printer Roller
C05210-00
Upper Case
E20001-00
LCD
P05203-00
Keypad
P05204-00
STN-SUB PCB
M05210-00
Battery Bracket
10
E00000-00
Battery
11
E50000-00
Thermal Printer Body
12
P05201-00
Main Board
13
E41101-00
Power Module
14
M05200-00
GND Terminal
15
GND Washer
16
GND Nut
17
C05211-00
Lower Case
18
M05211-00
CPU Module Cap
67
Part List
This Page is intentionally left blank.
68
Packing
Chapter 8. Packing
69
Packing
1. Description
Make it sure to pack products carefully according to the instructions in this chapter. Otherwise
the products may be damaged or missing. In case the basic packing is not available, another
proper packing can be applied. In case a user needs to pack a product and there is no proper
packing material, contact the head office of Mediana or a local agent office.
Be sure to mark the serial numbers on each packing unit and the shipping documents before
the shipment of the products. For a recalled product from customers, the document describing
the problems of the product should be enclosed.
2. Standard Carton Box Packing

The standard carton box packing is highly recommended if available, and the packing
procedure is as follows;
1. Reinforce the lower side of a standard carton box with packing tapes.
2. Place the box containing accessories on the bottom of the standard carton box.
3. Put the product in an air cap envelope and install the supporting buffers on the both sides.
Place the product in the standard carton box. The accessory box should be placed at the
center the box.
4. Cover the product with a protecting cover and place manuals and shipping documents on
the product.
5. Seal the upper side of the standard carton box tightly with packing tapes.
6. Complete the markings on the side of the standard carton box.
3. Repacking
In case of the standard carton box is not available, follow the below packing procedure.
1.
2.
3.
4.
5.
Prepare a box with a proper size.

Reinforce the lower side of the box with packing tapes.
Place the box containing accessories on the center of bottom of the packing box.
Fill the empty space of the both sides of the accessory box with buffing material.
Wrap the product with plastic wrap or put in a plastic envelope for keeping it clean. Place it
on the inner center of the box.
6. Fill the empty space of left, right and upper part of the box with buffing material.
7. Seal the upper side of the box tightly with packing tapes.
8. Complete the markings on the side of the box.
70
Specifications
Chapter 9. Specifications
71
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
Rejection
Input Impedance
Patient
Leakage
Current
100dB
> 50
< 10
Communication
PC communication with RS232 interface and LAN
Firmware Upload
Use the USB memory stick

AC: 50/60Hz
Filter
Low Pass Filter: 40, 100, 150Hz

Baseline Filter: 0.5Hz
Muscle Filter
Writer
72
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
Specifications
Electrical
Power Supply
AC or Battery operation
AC Input
100-240VAC 50/60Hz, 70VA
Fuses
Qty. 2, 250Vac T6.3AL, IEC(5x20mm)
Battery Type
Battery Capacity
Battery Charge Time
12V 3.8Ah, Rechargeable Nickel Metal Hydride Cylindrical

Cell
150 basic reports (Auto Mode) or 5hours continuous
operation (without printing)
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
Storage/Transportation
Condition
Temperature range -20~60

Humidity range 10%~95%(non-condensing)
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
73
Specification
IEC60601-1:
1988+A1:1991+A2:1995
General
requirements for Safety

IEC60601-1-4: 1996+A1:1999 General Requirements for
safety
collateral
standard:
programmable
electrical
medical systems
ISO10993-1: 2003 Biological evaluation of medical
devices Part 1: Evaluation and testing
Electrocardiograph
IEC60601-2-25:1993+A1:1999 Particular requirements for

the safety of electrocardiographs
Electromagnetic
IEC60601, sub clause 36
Compatibility
IEC60601-1-2:
2001+A1:2004
Electromagnetic
compatibility - Requirements and tests

IEC61000-3-2:2000 Harmonic current emissions
IEC61000-3-3:1995+A1:2001 Voltage fluctuations/Flicker
Emissions
IEC61000-4-2:1995+A1:1998+A2:2001
Electrostatic
Discharge(ESD)
IEC61000-4-3:2002+A12002
Radiated
RF
electromagnetic field
IEC61000-4-4:2004 Electrical fast transient/burst
IEC61000-4-5:1995+A1:2001 Surge current
IEC61000-4-6:1996+A1:2001
Conducted
disturbances,
induced by RF field
IEC61000-4-8:1993+A1:2001 Power frequency(50/60Hz)
magnetic field
IEC61000-4-11:1994+A1:2001
Voltage
dips,
short
interruption and voltage variation on power supply input

lines
CISPR11(EN55011) RF Emissions Group 1, Class B
Labeling
Marking
74
EN1041:1998 Information supplied by the manufacturer

with medical devices
EN980:2003 Graphical symbols for use in the labeling of
medical devices
Functional Description
Chapter 10. Functional Description
75
1. Description
This chapter provides functional descriptions of the components of the YM412i Cardiograph.
These descriptions are at the functional-block level.
2. System Overview
The YM412i system performs acquisition, analysis, printing, storage, and transfer of ECG
waveforms and other patient clinical data.
3. Hardware Functional View

Control of the YM412i is provided by application software running on the main control board,
interacting with numerous hardware and software subsystems. The following are high-level
descriptions of these various subsystems.
The hardware consists of the following function blocks:
y
Main Board: B1
CPU Module: B2
STN-SUB Board: B3
Keypad Board: B4
Power Module: M1
LCD Module: M2
Battery Module: M3
Thermal Printer Module: M4
Figure 10-1. Block Diagram of Entire instrument
76
1) Power System
The YM412i power system contains the power module and battery.
A power module consists of AC-DC Converter (AC/DC), DC-DC Converter (DC/DC) and
F
U
S
E
AC/DC
Switching
Power Supply
16V
Charger with
Charger Management
MCU
ON/OFF
Relay
DC/DC
(Main Power)
DC/DC
(Thermal Printer
Motor)
DC/DC
(Thermal Printer
Header)
F
U
S
E
Indication
LED
CON
FILTER
AC Inlet
AC
Line Power
F
U
S
E
Battery Charger.
Battery
Pack
Ni-MH 1.2V
3800mAh
10Cell
DC/DC
(LCD Negative
power)
Power
Control Signal
Connector
Connector
Main Board
Figure 10-2. Power System Block Diagram

y
Battery charging
When the AC power cord is plugged in, the battery automatically begins to charge. The battery
charging status transmitted the LED and TTL level signal. The battery is in connection the fuse
and built in thermistor, thermostate for battery safety.
77
2) DC Power Supply
YM412i provides the power to each circuit part through the power system like the following
block diagram.
Figure 10-3. DC Power Supply Block Diagram

y
16V Stand by
Supply the 16V for power management unit. YM412i maintain the ready.
y
+5V Main Power
The +5V Main Power is a supplier of the 5V Logic, 3.3V Logic and Isolation analog power for
overall system operation.
y
+8.5V Thermal Printer Header
Operation of the thermal printer header

y
+7.5V Thermal Printer Motor
Operation of the thermal printer motor

y
-20V STN LCD Negative Power
Operation of the STN LCD
78
3) Main CPU Module

Main CPU Module contains the processor S3C2440A, NOR Flash, SDRAM and all sorts of
hardware driver.
CPU Module controls each system and performs management, analysis, display, printing and
storage of acquisition data.
Figure 10-4. Main CPU Module Block Diagram
4) RTC Power Interface

The Li-lon battery and 3.3V supplies power for operation of Real Time Clock (RTC).
Figure 10-5. RTC Power Interface Block Diagram
79
5) Display Interface
The 320X240 STN mono LCD is handled by the LCD controller in the main process.
Figure 10-6. Display Interface Block Diagram
6) Keypad Interface
YM412i consist of multi function keys of ten number keys (hot keys) and six function keys
(direction keys). And keypad includes power on/off key and three indicators.
S3C2440A
Figure 10-7. Keypad Interface Block Diagram
80
7) Thermal Printer Interface

Thermal Printer consists of Thermal header and step motor. Each data controlled by main
processor and timing adjusted by CPLD and FIFO.
Thermal Printer
Header
Thermal Printer
Motor
STB1
STB2
STB3
STB4
LAT
DATA
CLK
Motor
Phase
Logic
Buffer
CPLD
Data
FIFO
Con.
Sig.
Motor
Driver
Data Bus
Con. Sig.
IO Control
Data Bus
& Control
Signal
GPIO
Figure 10-8. Thermal Printer Interface Block Diagram
8) Communication Interface
YM412i have interface methods of the UART serial, TCP/IP and USB communication. Great
capacity data can backup using the internal SD card (optional).
LAN Connector
Serial UART
10/100 T
Interface
Eternet
Phyceiver
TCP/IP
Stack
Data Bus
Con. Sig.
RS-232
Driver
USB
HOST
Data&
ADD. BUS
UART
USB
SD CARD
SPI
Figure 10-9. Communication Interface Block Diagram
81
9) Analog Signal Acquisition Interface

Acquisition data digitized by AD converter and then transfer to main processor.
Isolation barrier
RX
TX
UART
GPIO
RL Driver
Saturation
Detecter
+5V
+5V
Discharger
-5V
Figure 10-10. Analog Signal Acquisition Interface Block Diagram
82

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YM412i

10. Printer .................................................................................................................... 42

Figure 2-2. Rear Panel.

Figure 2-3. Right Panel

Figure 3-1. Cleaning the printer head..

Figure 3-2. Changing Printer Paper..

Figure 3-3. Firmware upgrading Screen.

Figure 4-1. Maintenance Menu Screen...............................................................................

Figure 6-1. Disassembly Flow Chart

Figure 6-2. Upper Case Disassembly..

Figure 6-3. Lower Case Disassembly.

Figure 6-4 Detach the Upper and Lower case..

Figure 6-5 Battery Disassembly

Figure 6-6 Thermal Printer Disassembly

Figure 6-7 Main Board Disassembly

Figure 6-8 Fuses replacement 53

Figure 6-10 Replacing the CPU Module..

Figure 6-11. Keypad Disassembly

Figure 6-12. LCD and STN-SUB PCB Disassembly.

Figure 7-1. YM412i Parts.

Figure 10-1. Block Diagram of Entire instrument.

Figure 10-2. Power System Block Diagram

Figure 10-3. DC Power Supply Block Diagram.

Figure 10-4. Main CPU Module Block Diagram.

Figure 10-5. RTC Power Interface Block Diagram

Figure 10-6. Display Interface Block Diagram..

Figure 10-7. Keypad Interface Block Diagram..

Figure 10-8. Thermal Printer Interface Block Diagram

Figure 10-9. Communication Interface Block Diagram..

Figure 10-10. Analog Signal Acquisition Interface Block Diagram.

Table 4-1 Top panel indicators for power source

Table 4-2 Battery Charging Status Indications

Table 4-3. Earth Leakage Current Values..

Table 4-4. Patient Leakage Current Values..

Table 4-5. Patient Leakage Current Values-Mains Voltage on Applied Part.

Table 4-6. Allowable Leakage Current

Table 5-1 Troubleshooting Topics...

Table 5-2 Battery and AC Power Troubleshooting.

Table 5-3 Display Troubleshooting.

Table 5-4 Button Troubleshooting..

Table 5-5 Beep Troubleshooting..

Table 5-6 Printer Troubleshooting..

Table 5-7 Others...

Table 6-1. Part Descriptions Lower Case Assembly...

Table 6-2. Part Descriptions Upper Case Assembly...

Table 6-3. Main PCB to Keypad PCB Cable..

Table 6-4. Main PCB to STN-SUB PCB Data Cable.

Table 6-5. STN SUB PCB to LCD Back Light Cable

Table 6-6. Main PCB to Printer Unit Head Cable.

Table 6-7. Main PCB to Printer Unit Motor Film Cable..

Table 6-8. Main PCB to Printer Unit Motor Film Cable..

Table 6-9. Main PCB to SMPS Module Cable

Table 6-10. SMPS to Battery Cable.

Table 6-11. SMPS to Battery Cable.

Table 7-1. YM412i Part List..

This page is intentionally left blank.

YM412i Service Manual

The product YM412i bears the CE marking

indicating its conformity with the

The product is designed to comply with IEC60601 requirements. It is a protection class I,

The radio-interference emitted by this device is within the limits specified in

assembly operations, extensions, readjustments, modifications, or repairs are carried out by

YM412i Service Manual

Warning: If a safe ground connection is not ensured, operate the cardiograph