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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

......................... 57 8..................................................................................................................................................... Others .................. Description .............. 76 3........ Specifications............................................................. 60 Chapter 7................................................................................... 69 1..................................................................... How to Use Disassembly Guide .................... 50 6. Printer .................. 71 Chapter 10......................................................... Lower Case Disassembly.......................... 66 Chapter 8.................................................... 75 1................ 51 7................................................................................................................ System Overview .................................................................................................................................................................... 65 1............................... 70 3....... Disassembly Flow Chart ........ Disassembling Cases..................... Parts List............................................................................................ Standard Carton Box Packing ......... Packing .................................................... Upper Case Disassembly..... 45 1........ Specification of cables and connectors ...................................... 70 2.............. 50 5.................................. 76 2..................................................................................... Functional Description ................................ Repacking..........................10....................................................................................................................... 42 11................................................................................................................... Opening the device........................................................ Hardware Functional View .......................................... 46 2............ Disassembly Guide ......................................................................... Description ...................... 43 Chapter 6........................................................... 47 4.......................................... 76 ........................... 47 3.................................................................. Description ................ 70 Chapter 9.......................................................................... Description ...............................

... 24 Figure 4-1.. Disassembly Flow Chart…………………………………………………………… 47 Figure 6-2. Changing Printer Paper……………………………………………………………. Upper Case Disassembly…………………………………………………………........ 79 Figure 10-5. DC Power Supply Block Diagram……………………………………………….... YM412i Parts…………………………………………………………………………. 82 . 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………………………………………………………. Block Diagram of Entire instrument……………………………………………... Display Interface Block Diagram………………………………………………. 21 Figure 3-2. 58 Figure 7-1. Analog Signal Acquisition Interface Block Diagram……………………….. Power System Block Diagram…………………………………………………… 77 Figure 10-3. 48 Figure 6-3. Firmware upgrading Screen………………………………………………………......... 54 Figure 6-10 Replacing the CPU Module……………………………………………………….......... 66 Figure 10-1.. 80 Figure 10-8. Lower Case Disassembly…………………………………………………………....... 76 Figure 10-2....... 81 Figure 10-10. Right Panel…………………………………………………………………………… 15 Figure 3-1... 15 Figure 2-2.. 80 Figure 10-7. LCD and STN-SUB PCB Disassembly…………………………………………......... Keypad Disassembly……………………………………………………………… 57 Figure 6-12.... 29 Figure 6-1.. Rear Panel…………………………………………………………………………….. RTC Power Interface Block Diagram…………………………………………… 79 Figure 10-6. 15 Figure 2-3..... Keypad Interface Block Diagram………………………………………………. Top Panel……………………………………………………………………………. Main CPU Module Block Diagram……………………………………………….. 78 Figure 10-4. 22 Figure 3-3.. Maintenance Menu Screen..... 49 Figure 6-4 Detach the Upper and Lower case………………………………………………....... 55 Figure 6-11......... Thermal Printer Interface Block Diagram……………………………………… 81 Figure 10-9. Communication Interface Block Diagram…………………………………….Figures Figure 2-1.. Cleaning the printer head…………………………………………………………..

. List of Components…………………………………………………………………. Main PCB to Printer Unit Motor Film Cable……………………………………. Main PCB to Printer Unit Head Cable……………………………………………. 41 Table 5-5 Beep Troubleshooting………………………………………………………………. 60 Table 6-4. Main PCB to STN-SUB PCB Data Cable…………………………………………. 40 Table 5-4 Button Troubleshooting……………………………………………………………. 67 .. SMPS to Battery Cable……………………………………………………………... Patient Leakage Current Values………………………………………………….. Part Descriptions – Upper Case Assembly……………………………………. 37 Table 5-2 Battery and AC Power Troubleshooting………………………………………….... 42 Table 5-7 Others…………………………………………………………………………………. Main PCB to Keypad PCB Cable…………………………………………………. 63 Table 7-1.. 62 Table 6-7... 32 Table 4-6. 31 Table 4-4. 43 Table 6-1. 38 Table 5-3 Display Troubleshooting……………………………………………………………. 62 Table 6-8. 63 Table 6-11. 61 Table 6-5. Patient Leakage Current Values-Mains Voltage on Applied Part…………….. STN SUB PCB to LCD Back Light Cable………………………………………… 61 Table 6-6.Tables Table 2-1.. 56 Table 6-2. 62 Table 6-9. Main PCB to Printer Unit Motor Film Cable……………………………………. Earth Leakage Current Values……………………………………………………. 32 Table 4-5. Main PCB to SMPS Module Cable………………………………………………… 63 Table 6-10.. SMPS to Battery Cable……………………………………………………………. 16 Table 4-1 Top panel indicators for power source…………………………………………… 27 Table 4-2 Battery Charging Status Indications……………………………………………… 27 Table 4-3... Part Descriptions – Lower Case Assembly……………………………………. Allowable Leakage Current………………………………………………………… 33 Table 5-1 Troubleshooting Topics…………………………………………………………….. 41 Table 5-6 Printer Troubleshooting……………………………………………………………. 59 Table 6-3. YM412i Part List………………………………………………………………….

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Information

Chapter 1. Information

YM412i Service Manual

9

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 Ⅱa (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 contains service information; operating instructions are provided in the user
manual of the instrument.

y

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 operator’s manual.
y

Mediana considers itself responsible for the effects on safety, reliability, and performance of
the equipment, only if;

① assembly operations, extensions, readjustments, modifications, or repairs are carried out by
Mediana or by persons authorized by Mediana,
② the electrical installation of the relevant room complies with the applicable national and local
requirement, and
③ 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

YM412i Service Manual

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.

YM412i Service Manual

11

If battery cable polarity is reversed. observe the protective measures against damage due to ESD (electrostatic discharge). or cardiograph during defibrillation. it is likely that circuit damage will occur. 12 YM412i Service Manual . patient cable. The use of non-approved patient electrodes may degrade cardiograph performance. Caution: If internal battery cable has been disconnected. Caution: For continued protection against risk of fire. Caution: Only use patient electrodes that are approved by Mediana. pay particular attention to polarity of the cable before reattaching.Information Warning: Do not touch the patient. Death or injury may occur from the electrical shock delivered by the defibrillator. Caution: During repairs/service interventions. replace only with same type and rating of fuse.

Introduction Chapter 2. Introduction YM412i Service Manual 13 .

ECG waveforms are displayed on the graphic LCD.Introduction 1. which is designed for easy operation. Also the YM412i product can be connected to a personal computer based Cardiology Information System to store information on patients and ECG data. 14 YM412i Service Manual . Device description The purpose and function of YM412i product is to diagnose electrocardiogram. and the displayed waveforms can be printed with the built-in thermal printer.

side and rear views of the YM412i.Introduction The section shows top. see the Operator’s manual. For additional details. Top Panel Figure 2-2. Thermal Printer Graphic LCD Keypad Figure 2-1. Rear Panel Figure 2-3. Right Panel YM412i Service Manual 15 .

List of Components ① YM412i Main 1EA ② Clamp Electrodes 1Pack ③ Chest Electrodes 1Pack ④ Patient Cable 1EA ⑤ Power Cable 1EA ⑥ Thermal Paper 1Pack ⑨ Operator’s manual 1EA ⑩ Service manual 1EA ⑦ Serial Cable 1EA ⑧ Ground Cable 1EA NOTE: The above pictures vary from the original in some points. Standard Accessories Table 2-1. 16 YM412i Service Manual .Introduction 2.

TEL +82-33-742-5400 FAX +82-33-742-5618 YM412i Service Manual 17 . 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.Introduction 3.

18 YM412i Service Manual .Introduction This page is intentionally left blank.

Basic Care and Maintenance Chapter 3. Basic Care and Maintenance YM412i Service Manual 19 .

Caution: When cleaning. 1) Cleaning the Cardiograph y When cleaning the equipment. Caution: Do not spill liquids on the surface of the cardiograph. Description This chapter contains information on basic cardiograph care and periodic maintenance. If further technical assistance is required. Cleaning Warning: Do not spray. While washing. pay special attention so that cleaning liquid or something like that may not soak into the inside of equipment. ammonia or acetone as main ingredients. For wash the product. accessories. Caution: Do not use strong solvents or abrasive cleaning materials.Acetone. Caution: Do not use any of the following to clean the cardiograph: . wipe the surface lightly with a soft cloth. soaked with a general-use or non-invasive detergent. wipe it with sponge. pour or spill liquid materials on the product. Basic cleaning and maintenance guidelines are also included in the Cleaning and Maintenance chapter of the YM412i Operator’s manual. make it sure that any liquid material should not infiltrate into connectors or covers. 2. Ethylene oxide 20 YM412i Service Manual . And do not wash the product or the accessories with soluble or invasive liquid. Iodine-based cleaners. soft cloth or something like that wetted with soapy water and never use the detergent using alcohol. Equivalent attention should be paid to cables and accessories. connectors. avoid the lead wire connectors and patient cable connectors. Phenol-based cleaners. y When cleaning the equipment. switches or cases.Basic Care and Maintenance 1. contact the Mediana Service Center.

. . 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. 3) Cleaning the Printer Head . Caution: Do not use abrasive materials. Caution: Do not wet the connectors. Chlorine bleach. Ammonia-based cleaners 2) Cleaning the Patient Cable and Electrodes Caution: Do not use isopropyl alcohol.Cidex Ortho Phthaladehyde . Figure 3-1.Basic Care and Maintenance sterilization.After cleaning.Unclean printer head can be cause of reducing print quality. Clean patient cable and lead wires with any of the following: .Cetylcide . dry printer head sufficiently and then use it.Open the printer cover and then wipe it softly without rubbing it too hard by wetting swab with 90% alcohol.Vesphene 2 Aqueous Phenolic Germicidal Agent y Wring excess moisture from the cloth before cleaning. Cleaning the printer head YM412i Service Manual 21 .

Basic Care and Maintenance 3. 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. 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. 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. Changing Printer Paper 22 YM412i Service Manual . Figure 3-2.

For optimal battery performance: y Only use Mediana Ni-MH battery. Battery life varies depending on frequency of use and maintenance. and it is necessary to discharge and charge a battery regularly for recovery to the normal battery capacity. consider replacing it. Caution: Repeated undercharging of the battery will damage and reduce battery life. For improved battery life. Please refer to the Chapter 6. Disassemble Guide. Mediana recommends that the Ni-MH battery for YM412i product should be replaced every two years. refer to Chapter 6. It takes around 6 hours to charge a battery. y Keep the cardiograph plugged in when not in use. keep the cardiograph plugged in when not in use. YM412i Service Manual 23 . To replace or remove the battery. If the battery has been fully charged and requires recharging after a few ECGs. 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. Disassembly Guide for more information.Basic Care and Maintenance 4. Battery maintenance and care Charging the battery will be required if the YM412i product has not been used for a long time. NOTE: The capacity of a battery will be decreased if the YM412i product has not been used for a long time without charging it. Caution: Follow local government ordinances and recycling instructions regarding disposal or recycling of device components. Connect the device to the AC power source for charging the battery. including batteries.

After a few seconds. 24 YM412i Service Manual . 5) The device will display the firmware update screen as shown below figure 3-3. Caution: If any problem during Firmware upgrade. Before finish the booting screen. or upgrading firmware with a new system version. turn the device off. 3) Connect the USB memory and device. Caution: When a new firmware uploading is completed. dispose if it according to local ordinance. Firmware upgrading Screen 7) After completion of upgrade. contact the Mediana service center. The USB Memory required for firmware upgrade. 6) The firmware upgrades by it self. 6. press ENTER ESC (ESC) and then press RUN (Enter). It may be fail in according with the type of USB memory. Firmware Upgrade This section is for the purpose for reloading firmware in the device when the possibility of corrupted firmware exists. Figure 3-3. the device is set to the default. booting screen appears. 4) After turn on the YM412i. dispose of these items in accordance with local ordinances. When any of the cardiograph accessories reach the end of their product life. 1) Turn the device off. turn on again. 2) The new firmware (Folder name: Y412update) inserted in the USB memory. Cardiograph and Accessory Disposal When the cardiograph has reached the end of its product life.Basic Care and Maintenance 5.

Performance Verification and Safety Tests YM412i Service Manual 25 .Performance Verification and Safety Tests Chapter 4.

26 Connect the cardiograph to AC power source using proper power cord. 2. Press Power button. Performance Verification Tests 1) Visual Inspection 1. Press Power button. 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. After the cardiograph operates in normal mode. 5. 4. Test Equipment The following test equipment is required to perform the complete set of Performance Verification tests: y ECG Simulator y Digital Multi Meter y Electrical Safety Tester y ECG patient cable 3. 3. Replace any damaged or missing items.3 Basic care and maintenance. YM412i Service Manual . and then verify that the cardiograph is turned on. The level of testing required corresponds to the type of service performed. See Chapter. 2. Verify AC IN( ) and Battery( ) in indicators is lit. Clean the patient cable as necessary. and then verify that the cardiograph is turned off. 7. The performance verification tests verify proper operation of the YM412i following a service event. disconnect the power cord. 2) Power on test To process a completed power in test. Verify Power ON( ) in indicator is lit. you must completely reboot the cardiograph. Description This chapter describes the tests and inspections required to verify performance of the YM412i following a service event. Battery( ) indicator is off. and Power ON( ) indicator is lit. Verify AC IN( ). 1.Performance Verification and Safety Tests 1. 6. 3.

Follow the below Battery Functional Test to check the full charge. Fully charged battery will not do change. and then the flashing stops when charging is completed. Charge the battery for more than 6 hours. When the AC power cord is plugged in. 2. 3. Table 4-2 Battery Charging Status Indications Battery conditions Battery charging status indicator( Full charged On Charging Flashing Operation Off YM412i Service Manual ) 27 . yellow LED on flashes while charging is under progress.Performance Verification and Safety Tests 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. Connect the electric cord to the AC power source of the device. 4. the battery automatically begins to charge. and then connect the electric cord to the external power supply. 1. The charging battery can be automatically charged by inputting AC power. Regular full charge and discharge is required for recovery to the normal capacity.

Performance Verification and Safety Tests 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. Connect ECG simulator to the YM412i product. Before testing these functions. and then connect the electric cord to the external power supply. 10. 6. 2. the battery should be fully charged. If device passes this test. 5. Input the password “1560”. ▲ → Maintenance 2. and press (Enter) to show the maintenance window. 3. 1. Check if a signal of the ECG simulator is displayed on the LCD screen. 7. Press the “Power” button on the product and check if the indicator “ ” is lit. 4. Move shadow box( ) to the Maintenance. 9. Press the “Power” button to stop operation. The device should be operated for more than 90 minutes. The device should generate ECG graphs more than 30 times. 28 YM412i Service Manual . Check if a message of “Battery Low” is displayed before the full discharge. Adjust the ECG simulator so that the heart rate becomes 60bpm and the amplitude becomes 1mV. 8. Connect the electric cord to the AC power source of the device. Caution: When the battery using more than 6months. will gradually reduce battery life. 5) LCD Test MENU 1. immediately recharge battery. and press (ENTER) key to show the password input window. 3.

YM412i Service Manual 29 .Performance Verification and Safety Tests Figure 4-1. use the LCD test. To verify or optimize cardiograph LCD state. and press (ENTER) key to display the test screen. Move shadow box( ) to the Maintenance. Maintenance Menu Screen 4. and press (ENTER) key to show the password input window. contact qualified service personnel or Mediana service center. 6) Printer Test MENU 1. ▲ → Maintenance 2. Move shadow ) to LCD Test. If something box( is the matter with the LCD.

2. Noise should measure less than 1mm.Performance Verification and Safety Tests 3. Select Automatic Mode and then press “RUN” button to start printing. If something is the matter with the test page. clean the printer header. 6. Press the “Power” button on the product. Use this to verify proper printer performance or when reports appear to have print quality errors. Set ECG simulator as follows. The Printer Test is used to verify that the cardiograph printer is able to correctly print the test page. NOTE: Noise may be an artifact of poor connections to the simulator or position of the cables. and press (Enter) to show the maintenance window. Connect Mediana ECG cable to ECG cable connector on the cardiograph’s right panel. 4. y Heart rate: 60bpm y Amplitude: 1mV y Normal sinus rhythm 5. Connect the YM412i product to the AC power supply. Verify the following when printing is complete: y Trace activity for all 12 leads. Input the password “1560”. 5. y No gross distortion of complexes or calibration pulses y Calibration pulse amplitude is correct. 6. After a few seconds. If noise appears. Contact qualified service personnel or Mediana service center. 7) ECG Simulation 1. check the connectors or adjust the cable drape. The method of printer cleaning refers to Chapter 3. 4. 8. check if ECG waveforms are displayed on the LCD screen. Basic care and Maintenance. with no baseline wander. 7. Move shadow box( ) to Printer Test. 3. if problem persists after printer header cleaned. 30 YM412i Service Manual . 7. and press (ENTER) key to print the printer test page.

The current used for this test is less than or equal to 4Volts RMS. The tests may be performed under normal ambient conditions of temperature. 50 to 60Hz. Connect the analyzer resistance input lead to the equipotential terminal on the rear of the device. Table 4-3.Earth Leakage Current This test is in compliance with IEC60601-1 earth leakage current. use the metal grounding stud in the back of the cardiograph. humidity and pressure and with line voltage. Verify that the analyzer indicates 100milliohms or less. Safety Test This section explains tests of the cardiograph’s electrical safety. Connect the device AC mains plug to the analyzer recommended by the analyzer operating instructions. Perform the test as recommended by analyzer operating instructions. The following is a general description of the tests to be performed. 3. the measuring circuits according IEC60601-1 are already implemented. 2. and 25Amperes.Patient Leakage Current This test is performed according to IEC60601-1 Standards on the Class I CF typed devices. 1. Earth Leakage Current Values Condition Allowable Leakage Current (microamps) Normal Condition 500 Single Fault Condition 1000 3) Leakage Current . 1. The tests are generally performed with Safety Testers. and record the worstcase value. Test both Normal and Reverse polarity line connections for each test. For each condition. Clause 19. y If a ground reference point is needed for the testing. YM412i Service Manual 31 . Earth leakage current is measured under various condition of the AC mains and protective earth conductor. The suggested Safety Analysis Tests refer to the international standard IEC60601-1. 2. 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. 2) Leakage Current . The applied voltage for IEC60601-1 the voltage is 264V AC. Patient leakage current in this test is measured from any individual patient connection to earth (power ground). Connect the device AC plug to the electrical safety analyzer as recommended by the analyzer operating instructions. the measured leakage current must not exceed that indicated in Table 4-1. 50-60Hz. on most of them.Performance Verification and Safety Tests 4.

1. 2.Performance Verification and Safety Tests 1. Patient Leakage Current Values-Mains Voltage on Applied Part Condition Allowable Leakage Current (microamps) Normal polarity (Single Fault Condition) 50 Reverse polarity (Single Fault Condition Reverse Mains Voltage) 32 YM412i Service Manual 50 . Patient Leakage Current Values Condition Allowable Leakage Current (microamps) Normal Condition 10 Single Fault Condition 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. 2. Set the electrical safety analyzer as recommended by the electrical analyzer’s operating instructions. 4. the measured leakage current must not exceed that indicated in Table4-2. 3. For each condition. Connect the device’s AC mains power cord to the electrical analyzer as recommended by the electrical analyzer’s operation instructions. 5. Connect ECG test cable between ECG connector on the device and appropriate input connector on analyzer. Connect the device’s AC mains power cord to the electrical analyzer as recommended by the electrical analyzer’s operation instructions. Set the electrical safety analyzer as recommended by the electrical analyzer’s operating instructions. 3. Connect ECG test cable between ECG connector on the device and appropriate input connector on analyzer. Perform the test as recommended by analyzer operating instructions. Patient leakage current is then measured from any individual patient connection to earth. For each condition. Patient leakage current is measured with normal and reverse mains polarity. In this test. Turn on the YM412i device. Turn on the YM412i device. Table 4-5. Table 4-4. Perform the test as recommended by analyzer operating instructions. Patient leakage current is measured with normal and reverse mains polarity. 110% of mains voltage is applied between each patient connection and earth (power ground). 4. the measured leakage current must not exceed that indicated in Table4-3. 5.

50-60Hz.Performance Verification and Safety Tests 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. 1. Allowable Leakage Current Condition Allowable Leakage Current (microamps) Normal Condition 10 Single Fault Condition 50 YM412i Service Manual 33 . Connect the device’s AC mains power cord to the electrical analyzer as recommended by the electrical analyzer’s operation instructions. Set the electrical safety analyzer as recommended by the electrical analyzer’s operating instructions. 2. Patient auxiliary current is measured between each ECG test lead. Table 4-6.

Performance Verification and Safety Tests This page is intentionally left blank 34 YM412i Service Manual .

Troubleshooting YM412i Service Manual 35 .Troubleshooting Chapter 5.

Replacement Support The replaceable parts of this product are PCBs. users can contact the Mediana Service Center. For other problems. Disconnect a power cord from YM412i before attempting to open or disassemble YM412i. 36 YM412i Service Manual . 5. Service Technicians Only technically qualified service operators can carry out disassembly & adjustment of a device and removal & replacement of parts. replace it with a new one according to the “Chapter 6 Disassembly Guide”. Description This chapter suggests troubleshooting tips for problems with YM412i. 4. contact the Mediana Service Center. replace the new PCB with the original one and find another solution as instructed in this chapter. main assemblies and some parts. Warning: Electrical shock hazard. To get a replacement part. 3. If a PCB is considered to be defect. NOTE: The troubleshooting tips in this chapter cover the main troubles that users possibly encounter. Troubleshooting Topics The following table lists all of the Troubleshooting topics included in this chapter. In case a qualified service operator is not available. In case the error still happens. The below tables will show the possible problems of the device and the recommendable troubleshooting procedures. Check if the error is corrected after replacement and carry out all functional tests. contact the Mediana Service Center. not included in these troubleshooting tips. 2. Getting Replacement Parts Mediana provides technical support and replacement parts. referring to the Chapter 5 “Replacement Parts” for part names and numbers.Troubleshooting 1.

Screen is totally black color or white color (no data is visible) when the power is turned on. 1. 2. Power is not on when pressing the “POWER” button in condition the external AC power line is connected to the device. Some of buttons do not work tough the power is turned on. Backlight is not activated while data is displayed on the screen. 4. Display values are missing or erratic. When AC power cord is connected to the device. Buttons do not respond.Troubleshooting Table 5-1 Troubleshooting Topics Topic Symptom 1. Button Beep 1. 1. 1. Printer does not response even though printing related buttons are Printer pressed. AC indicator on the Batteries and AC Power front panel is not lit. Battery does not charge. 2. 2. The device does not operate when disconnected from AC power. YM412i Service Manual 37 . 3. 1. Display 2. 2. 4. One leads signal or more come out in straight lines or too much noise is generated. 3. One lead signal or more come out in straight lines or too much noise is Other generated. Audible beep does no sound. Data (signal & text) is not shown even though the screen is normal. Printer generates empty paper even in case the printer motor works and the printing paper is loaded.

replace the main cable. AC main board and the power module. 38 YM412i Service Manual . Disassembly Guide]. If connection is good. 2-5 Ensure the keypad is connected to the main board. replace the power module. After it has dropped. 3-3 The battery may be overheated. Battery and AC Power The following table describes common problems with batteries and AC power. 2-3 Replace the AC fuse. If indicator is not lit. is not lit. 1. replace the keypad. 2-4 Check the main cable and ensure that it is connected to the main board and the power module. 2-2 Ensure AC power indicator is lit. If connection is good. 3-1 The battery may be discharged. 3-2 Check the main cable and ensure that it is connected to the main board and the power module. operate the device. replace the main board. When AC power cord is 1-3 Check the main cable and ensure that it is connected to the connected to the device. 2-1 Ensure power cord is plugged into the appropriate AC outlet of voltage and frequency. The device does not operate when disconnected from AC power. 2-6 If the problem persists. ensure the keypad cable is connected to the keypad assembly and the main board. 1-2 Replace the AC fuse. 3-4 If the problem persists. 3-5 If the problem persists.Troubleshooting 6. refer to [Chapter 6. Power is not on when pressing button the in “POWER” condition the external AC power line is connected to the device. replace the battery. replace the main board. To recharge the battery. 3. 1-5 If the problem persists. replace the power module. 1-6 If the problem persists. If the action requires replacement of the components. indicator on the front panel 1-4 If indicator is not lit. connect a power cord to AC mains over 6hours. 2. 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. replace the keypad.

YM412i Service Manual 39 . Battery does not charge. If connection is good. replace the battery. 4-2 If the battery fails to hold a charge. When the battery charging is completed. replace the keypad. While charging battery. 4.Troubleshooting 4-1 Ensure the keypad is connected to the main board. the Battery LED is lit continuously. Replace the power module if the LEDs are not lit. the Battery LED is flashed until battery charging is completed. 4-3 Verify the AC IN LED is lit. while on AC.

replace the main board. 4-5 If problem persists. 1. 4-3 AC supply may be wrong. 3-3 Replace the STN-SUB PCB if problem persists. 3-5 Replace the main PCB if problem persists. replace the main board. 2-1 Check the backlight cable and the data cable are connected to the STN-SUB PCB. If the action requires replacement of a PCB assembly or module. 1-6 If problem persists. re-setting the filter. 2-4 If problem persists. replace the patient cable. 2-2 Check the STN-SUB PCB connector is connected to the main PCB 2-3 If problem persists. replace the STN-SUB PCB. are 4-2 Verify position of the leadwire. Table 5-3 Display Troubleshooting Symptom Solution 1-1 Check the backlight cable and the data cable are connected to the STN-SUB PCB. replace the CPU module. 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. 4. operate the battery and check. 4-6 If problem persists. 1-4 If problem persists. 2-5 If problem persists. refer to Chapter 6. Display values missing or erratic.Troubleshooting 7. replace the LCD module. Display The followings are symptoms of problems relating to non-functioning displays. 3-4 Replace the LCD module if problem persists. ensure that the cables are properly connected. 40 YM412i Service Manual . 2. 1-5 If problem persists. and recommended action. replace the CPU module. 4-4 If problem persists. 4-1 If the patient cables are connected. Data (signal & text) is not shown even though the screen is normal. 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. replace the main board. turned on. replace the LCD module. 2-6 If problem persists. replace the LCD module. replace the STN-SUB PCB. 3-1 Check the backlight cable and the data cable are connected to the STN-SUB PCB. 3.

1-3 If the cable abnormal. replace the cable. turned on. 9. 2-5 If problem persists. replace the keypad PCB. 1-5 If problem persists. Button The following is a symptom of problems and recommended actions relating to buttons. 2-1 Check the keypad is properly connected to the main PCB. refer to Chapter 6. replace the cable. 2-4 If problem persists. Audible beep does no sound. Buttons do not respond. If the action requires replacement of a PCB assembly. 1-4 If problem persists. Beep The following is a symptom of problems and recommended actions relating to beep. work tough the power is 2-3 If the cable abnormal.Troubleshooting 8. 1-4 If problem persists. 1-2 Check beep setting in system setup menu. Table 5-4 Button Troubleshooting Symptom Solution 1-1 Check the keypad is properly connected to the main board. If the action requires replacement of a PCB assembly. YM412i Service Manual 41 . 1. 1. replace the keypad PCB. Table 5-5 Beep Troubleshooting Symptom Solution 1-1 Check beep silence status. replace the main board. 2. replace the main board. Some of buttons do not 2-2 Check the cable between main board and the keypad PCB. 1-2 Check the cable between main board and the keypad PCB. replace the main PCB. refer to Chapter 6. 1-3 Check the main cable between main board and the power module.

Printer The following is a symptom of problems and recommended actions relating to printer. replace the main board.Troubleshooting 10. Printer does not response 1-2 Check the printer related connections are properly secured. 1-5 If problem persists. replace the printer module. buttons are pressed. operate the device. 42 2-1 Open the printer cover and check the paper is properly loaded. replace the main board. (Only one side of paper is effective thus it will not work if the opposite side is loaded. After it has dropped.) 2-2 If problem persists. YM412i Service Manual . 2-3 If problem persists. 1. refer to Chapter 6. Printer generates empty paper even in case the printer motor works and the printing paper is loaded. Table 5-6 Printer Troubleshooting Symptom Solution 1-1 Open the printer cover and check if the paper is properly loaded. replace the printer module. If the action requires replacement of a PCB assembly. even though printing related 1-3 The printer header may be overheated. 1-4 If problem persists. 2.

2. replace the main board. generated. One lead signal or more 1-1 Check the patient cable is properly connected to the device. 4. 5. come out in straight lines or 1-2 Check the filters are properly setting. 1-4 if problem persists. 3. too much noise is 1-3 If problem persists. YM412i Service Manual 43 . Leads I and II 4-1 Check RA(or R) and RL(or N) lead wire and electrode. replace the patient cable. V1-V6(C1-C6) 5-1 Check V1-V6(C1-C6) and RL(or N) lead wire and electrode. Leads II and III 2-1 Check LL(or F) and RL(or N) lead wire and electrode. Others Table 5-7 Others Symptom Solution 1. Leads I and III 3-1 Check LA(or L) and RL(or N) lead wire and electrode.Troubleshooting 11.

44 YM412i Service Manual .Troubleshooting This page is intentionally left blank.

Disassembly Guide Chapter 6. Disassembly Guide YM412i Service Manual 45 .

special attention should be paid to the polarity of the power supply. The following parts of the YM412i product can be disassembled. NOTE: To get main replacement parts. y PCB y Battery y Cables y Printer y Case The following tools are used for disassembly. Caution: Do not operate the YM412i product right after repair or examination. If the polarity is reversed. 46 YM412i Service Manual . y y y Screwdriver (manual or automatic) Needle . Operate the device after completing all of the functional tests and safety inspections described in the Chapter 3.Nose Pliers Torque Warning: Electrical shock hazard. Caution: In case the internal battery cable is not connected. 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. contact the head office of Mediana Service Center. Description This chapter contains information on removing and replacing the YM412i components. the circuits may be damaged.Disassembly Guide 1. Failure in the functional test may cause misreading.

6-2 and 6-3. For more detailed information on disassembly. follow the step-by-step procedure of the flow charts described in Figure 6-1. The disassembly flow charts can be referred for removal or replacement of abnormal parts and partial assemblies. 3. How to Use Disassembly Guide Warning: Before attempting to open or disassemble the electrocardiograph. To find a replacement part of the YM412i product. The main PCB assembly is separated from the lower case assembly. disconnect the power cord from the electrocardiograph. Figure 6-1. refer to the Chapter 7 “Replacement Parts”. Disassembly Flow Chart YM412i Service Manual 47 . As described in the flow charts. Caution: Observe ESD (electrostatic discharge) precautions when working within the unit. And the chart is prepared for the qualified service operators approved by Mediana.Disassembly Guide 2. the disassembleable parts are basically sorted into the upper case assembly part and the lower case assembly part. For the list of replaceable parts. refer to the diagrams of the appendix. Disassembly Flow Chart The below disassembly chart is available only for the YM412i product. which is composed in direct manner for troubleshooting.

Upper Case Disassembly 48 YM412i Service Manual .Disassembly Guide Figure 6-2.

Detach connectors from PCB Power Module Detach the cable between main PCB and power module.Disassembly Guide Lower Case Main PCB 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. Detach the CPU Module from Main PCB Figure 6-3. Remove ground terminal from case. Lower Case Disassembly YM412i Service Manual 49 .

Figure 6-4 Detaching the Upper and Lower case 50 YM412i Service Manual . disconnect keypad and LCD cable. Some of the explanatory procedures contain pictures of the replacement parts. through pictures. Disassembling Cases This chapter shows the disassembly procedures.Disassembly Guide 4. 5. carefully raise the upper shell of the housing. Opening the device To open the YM412i release the 4 fastening screws (M3x8) on the underside of the device. for replacement of the assemblies or the parts of the YM412i product that are considered to be defect or damaged.

3. CPU Module. Disconnect the battery connector from the power module. 2. Lower Case Disassembly Main Board. Battery. Figure 6-5 Battery Disassembly YM412i Service Manual 51 . Remove 4 fastening screws (M3x6) from battery bracket. Separate the battery bracket and battery. Printer 1) Removing and Replacing the Battery 1. 4. Power Module.Disassembly Guide 6. Insert the new battery into the battery bracket.

Figure 6-6 Thermal Printer Disassembly 52 YM412i Service Manual . 2. Disconnect the printer film cable and motor film cable from the main board.6x8) from lower case.Disassembly Guide 2) Removing and Replacing the Printer 1. Remove 2 fastening screws (M2.

Remove 12 fastening screws (CPU module 4 screws: M3x5. Figure 6-7 Main Board Disassembly 4) Removing and Replacing the Fuse 1. 2. Remove 2 AC main fuses (250V/6. Detach the connection cable between main PCB and power module.Disassembly Guide 3) Removing and Replacing the Main Board 1. Replace new fuse. Main board 8 screws: M3x6) from lower case.3A) out of the socket if required. Figure 6-8 Fuses replacement YM412i Service Manual 53 . 2.

Remove the GND terminal from lower case. 2. Figure 6-9 Power Module Disassembly 54 YM412i Service Manual . 3.Disassembly Guide 5) Removing and Replacing the Power Module 1. Remove 5 fastening screws (M3x6) from lower case and detach the power module. Detach the connection cable between main PCB and power module.

Remove 4 supports male type and 4 supports female type 4. Detach the CPU module from main board. 2. Figure 6-10 Replacing the CPU Module YM412i Service Manual 55 .Disassembly Guide 6) Replacing the CPU Module 1. 3. Remove 4 fastening screws (M3x5) from lower case. Detach the CPU module cap from main board.

Part Descriptions – Lower Case Assembly 56 Part Codes Descriptions Qty E00000-00 Battery 1 M05210-00 Battery Bracket 1 E50000-00 Printer 1 P05201-00 Main Board 1 P05202-00 CPU Module 1 M05211-00 CPU Module Cap 1 E41101-00 Power Module 1 - Screw 23 YM412i Service Manual .Disassembly Guide Table 6-1.

STN-SUB PCB 1) Removing and Replacing the Keypad PCB 1. 2. LCD. Upper Case Disassembly Keypad PCB. Figure 6-11. Disconnect the cable between keypad PCB and main board. Remove 4 fastening screws (M3x6) from upper case.Disassembly Guide 7. Keypad Disassembly YM412i Service Manual 57 .

2.Disassembly Guide 2) Removing and Replacing the LCD and STN-SUB PCB 1. Remove 8 fastening screws (M3x6) from upper case. Figure 6-12. Disconnect the cable between LCD and STN-SUB PCB. Disconnect the cable between STN-SUB PCB and main board. 3. LCD and STN-SUB PCB Disassembly 58 YM412i Service Manual .

Disassembly Guide Table 6-2. Part Descriptions – Upper Case Assembly Part Codes Descriptions Qty P05203-00 Keypad PCB 1 H05212-00 Cable between keypad PCB and main board 1 E20001-00 LCD 1 P05204-00 STN-SUB PCB 1 H05211-00 Cable between STN-SUB PCB and main board 2 - Screw 12 YM412i Service Manual 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. Main PCB to Keypad PCB Cable 60 Main PCB Keypad PCB J5 J9 1 Color Description 1 Red Key column 3 2 2 Gray Key row3 3 3 Gray Key column 2 4 4 Gray Key row2 5 5 Gray Key column 1 6 6 Green Key row1 7 7 Gray Key column 0 8 8 Gray Key row0 9 9 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 YM412i Service Manual . Table 6-3.

C 3 3 N.C 4 4 OUT Description YM412i Service Manual 61 .Disassembly Guide Table 6-4. STN SUB PCB to LCD Back Light Cable STN SUB PCB LCD BLU J2 LCD 1 1 GND 2 2 N. Main PCB to STN-SUB PCB Data Cable Main PCB STN SUB PCB J10 J13 1 Color Description 1 Red +5V VDD 2 2 Gray Back light unit Power 3 3 Gray GND 4 4 Gray GND 5 5 Gray VSYNC 6 6 Green Video Data 0 7 7 Gray VDE 8 8 Gray Video Data 1 9 9 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.

4 4 Header CLK 5 5 5V VDD 6 6 Strobe signal 1 7.12.14.22 1.22 11V Header power 2 2 NC 3 3 Header data Latch signal.14.15 GND 16.11. 21.15 10.19 18.12.13.8 7.11. Main PCB to Printer Unit Motor Film Cable 62 Main PCB Printer unit PJ2 Paper Sensor 1 1 Phase A 2 2 Bias 3 3 Sensor out 4 4 GND YM412i Service Manual Description . 21.Disassembly Guide Table 6-6.17 16.8 Strobe signal 2 9 9 Header thermistor 10. Main PCB to Printer Unit Motor Film Cable Main PCB Printer unit PJ2 Motor 1 1 Phase A 2 2 Phase negative A 3 3 Phase B 4 4 Phase negative B Description Table 6-8.19 Strobe signal 2 20 20 Data Description Table 6-7.13. Main PCB to Printer Unit Head Cable Main PCB Printer unit PJ5 Head 1.17 Strobe signal 2 18.

Disassembly Guide Table 6-9. SMPS to Battery Cable SMPS GND Color Description Power inlet earth GND Terminal Green & Yellow GND terminal YM412i Service Manual 63 . Main PCB to SMPS Module Cable Main PCB SMPS WJ2 CJ3 1 Color Description 1 Red BATT Level Signal 2 2 Gray Battery charging status signal 3 3 Gray Ac check signal 4 4 Gray Main DC/DC ON/OFF Signal 5 5 Gray GND 6 6 Green SMPS Standby 16V 7 7 Gray STN Negative Power 8 8 Gray STN Negative Power 9 9 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 1 + Red Battery( +) 2 T Blue Thermistor 3 - Black Battery(-) Table 6-11.

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Parts List Chapter 7. Parts List YM412i Service Manual 65 .

contact Mediana Service Center. and accessories for the YM412i cardiograph. YM412i Parts 66 YM412i Service Manual . Description This chapter provides information on ordering replacement parts.Part List 1. Figure 7-1. supplies. To order replacement parts.

YM412i Part List No.Parts List Table 7-1. Part Codes Description 1 L05203-00 Keypad Overlay 2 L05202-00 LCD Overlay 3 C05250-00 Thermal Printer Cover 4 E60000-00 Thermal Printer Roller 5 C05210-00 Upper Case 6 E20001-00 LCD 7 P05203-00 Keypad 8 P05204-00 STN-SUB PCB 9 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 YM412i Service Manual 67 .

Part List This Page is intentionally left blank. 68 YM412i Service Manual .

Packing Chapter 8. Packing YM412i Service Manual 69 .

6. 2. another proper packing can be applied. 4. Complete the markings on the side of the box. 70 YM412i Service Manual . Standard Carton Box Packing The standard carton box packing is highly recommended if available. and the packing procedure is as follows. 3. Complete the markings on the side of the standard carton box. Reinforce the lower side of a standard carton box with packing tapes. contact the head office of Mediana or a local agent office. 1. 3. Put the product in an air cap envelope and install the supporting buffers on the both sides. For a recalled product from customers. Otherwise the products may be damaged or missing. 6. right and upper part of the box with buffing material. Seal the upper side of the box tightly with packing tapes. In case a user needs to pack a product and there is no proper packing material. 8. In case the basic packing is not available. 2. 5. 2. Repacking In case of the standard carton box is not available. Prepare a box with a proper size. Be sure to mark the serial numbers on each packing unit and the shipping documents before the shipment of the products. Reinforce the lower side of the box with packing tapes. 3. Fill the empty space of left. 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. Description Make it sure to pack products carefully according to the instructions in this chapter. Place the product in the standard carton box. 7. 4. follow the below packing procedure.Packing 1. the document describing the problems of the product should be enclosed. Cover the product with a protecting cover and place manuals and shipping documents on the product. Place the box containing accessories on the center of bottom of the packing box. 1. The accessory box should be placed at the center the box. Seal the upper side of the standard carton box tightly with packing tapes. Place it on the inner center of the box. 5. Place the box containing accessories on the bottom of the standard carton box.

Specifications Chapter 9. Specifications YM412i Service Manual 71 .

6 or 12 user-selectable Sensitivity/Gain 5. 10.22mm(H) STN mono LCD Resolution 320 X 240 dots Computerized Electrocardiograph Basic .5Hz Muscle Filter Writer 72 Type Thermal dot array Speeds 5. 50mm/sec Numbers of Traces 3. 10.100 ECG’s (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.Specification Display Type 103mm(W) X 77. 25. 100.05 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. 20mm/mV Speed Accuracy ±5% Amplitude Accuracy ±5% Paper Type/Size Thermal Roll. 110mm X 30m YM412i Service Manual . 150Hz Baseline Filter: 0.

Application of risk management to medical devices YM412i Service Manual 73 . 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 268.3AL.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.Requirements regulatory purposes ISO14971:2000 Medical devices . IEC(5x20mm) Battery Type Battery Capacity Battery Charge Time 12V 3.5 X 63 (W x L x H) mm Weight 2. 250Vac T6. 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 .Specifications Electrical Power Supply AC or Battery operation AC Input 100-240VAC 50/60Hz.8Ah.Quality management systems . 70VA Fuses Qty. 2.

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. sub clause 36 Compatibility IEC60601-1-2: 2001+A1:2004 Electromagnetic compatibility . 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 YM412i Service Manual .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.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.

Functional Description YM412i Service Manual 75 .Functional Description Chapter 10.

and transfer of ECG waveforms and other patient clinical data. printing. storage. System Overview The YM412i system performs acquisition. 2. The following are high-level descriptions of these various subsystems. These descriptions are at the functional-block level. interacting with numerous hardware and software subsystems. Description This chapter provides functional descriptions of the components of the YM412i Cardiograph. Hardware Functional View Control of the YM412i is provided by application software running on the main control board. analysis. Block Diagram of Entire instrument 76 YM412i Service Manual . The hardware consists of the following function blocks: y Main Board: B1 y CPU Module: B2 y STN-SUB Board: B3 y Keypad Board: B4 y Power Module: M1 y LCD Module: M2 y Battery Module: M3 y Thermal Printer Module: M4 Figure 10-1. 3.Functional Description 1.

A power module consists of AC-DC Converter (AC/DC).2V 3800mAh 10Cell DC/DC (LCD Negative power) Power Control Signal Connector Connector Main Board Figure 10-2.Functional Description 1) Power System The YM412i power system contains the power module and battery. the battery automatically begins to charge. thermostate for battery safety. YM412i Service Manual 77 . Battery Pack Ni-MH 1. The battery is in connection the fuse and built in thermistor. The battery charging status transmitted the LED and TTL level signal. Power System Block Diagram y Battery charging When the AC power cord is plugged in. 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.

3V Logic and Isolation analog power for overall system operation. y +5V Main Power The +5V Main Power is a supplier of the 5V Logic. Figure 10-3. 3.5V Thermal Printer Header Operation of the thermal printer header y +7.Functional Description 2) DC Power Supply YM412i provides the power to each circuit part through the power system like the following block diagram.5V Thermal Printer Motor Operation of the thermal printer motor y -20V STN LCD Negative Power Operation of the STN LCD 78 YM412i Service Manual . YM412i maintain the ready. DC Power Supply Block Diagram y 16V Stand by Supply the 16V for power management unit. y +8.

Figure 10-4. Figure 10-5. display. SDRAM and all sorts of hardware driver. CPU Module controls each system and performs management. RTC Power Interface Block Diagram YM412i Service Manual 79 .3V supplies power for operation of Real Time Clock (RTC). NOR Flash.Functional Description 3) Main CPU Module Main CPU Module contains the processor S3C2440A. Main CPU Module Block Diagram 4) RTC Power Interface The Li-lon battery and 3. printing and storage of acquisition data. analysis.

Keypad Interface Block Diagram 80 YM412i Service Manual . S3C2440A Figure 10-7. And keypad includes power on/off key and three indicators. 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).Functional Description 5) Display Interface The 320X240 STN mono LCD is handled by the LCD controller in the main process. Figure 10-6.

Sig. Communication Interface Block Diagram YM412i Service Manual 81 . TCP/IP and USB communication. Thermal Printer Interface Block Diagram 8) Communication Interface YM412i have interface methods of the UART serial. Sig. Thermal Printer Header Thermal Printer Motor STB1 STB2 STB3 STB4 LAT DATA CLK Motor Phase Logic Buffer CPLD Data FIFO Con. Sig. RS-232 Driver USB HOST Data& ADD. BUS UART USB SD CARD SPI Figure 10-9.Functional Description 7) Thermal Printer Interface Thermal Printer consists of Thermal header and step motor. Great capacity data can backup using the internal SD card (optional). Each data controlled by main processor and timing adjusted by CPLD and FIFO. Motor Driver Data Bus Con. IO Control Data Bus & Control Signal GPIO Figure 10-8. LAN Connector Serial UART 10/100 T Interface Eternet Phyceiver TCP/IP Stack Data Bus Con.

Isolation barrier RX TX UART GPIO RL Driver Saturation Detecter +5V +5V Discharger -5V Figure 10-10.Functional Description 9) Analog Signal Acquisition Interface Acquisition data digitized by AD converter and then transfer to main processor. Analog Signal Acquisition Interface Block Diagram 82 YM412i Service Manual .