Acumulator model: GP380AFH10XMX

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 5400Fax: (82) 33 742 5618 Manufacturer
MEDIGATE INC. 1720-26, Taejang-dong, Wonju-si, Gangwon-do, Korea Tel: (82) 33 747
3552Fax: (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
Thisdocumentcontainsproprietaryinformationthatisprotectedbycopyright.AllRights Reserved.
Reproduction, adaptation or translation without prior written permission is prohibited, except as
allowed under the copyright laws. Warranty
Theinformationcontainedinthisdocumentissubjecttochangewithoutnotice.Mediana
makesnowarrantyofanykindwithregardtothismaterial,including,butnotlimitedto,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
Thedocumentpartnumberandrevisionnumberindicateitscurrentedition.Therevision
numberchangeswhenaneweditionisprintedinaccordancewiththeversionofthe 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
Panel15 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
Chart47 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
Disassembly51 Figure 6-6 Thermal
Printer Disassembly52 Figure 6-7 Main Board
Disassembly53 Figure 6-8 Fuses
replacement53 Figure 6-9 Power
Module Disassembly..54 Figure 6-10 Replacing
the CPU Module..55 Figure 6-11. Keypad
Disassembly57 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 Diagram77 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 Diagram79 Figure 10-6. Display Interface
Block Diagram..80 Figure 10-7. Keypad Interface Block
Diagram..80 Figure 10-8. Thermal Printer Interface
Block Diagram81 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 source27 Table 4-2 Battery Charging
Status Indications27 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
Current33 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 Cable61 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
Cable63 Table 6-10. SMPS to Battery
Cable.63 Table 6-11. SMPS to Battery
Cable.63 Table 7-1. YM412i Part
List..67 This page is intentionally left
blank. Information YM412i Service Manual9 Chapter 1. Information Information 10YM412i
Service Manual 1. General Information
TheproductYM412ibearstheCEmarkingindicatingitsconformitywiththe
provisionsoftheCouncilDirective93/42/EECconcerningmedicaldevicesandfulfillsthe essential
requirements of Annex I of this directive. It is class a (MDD) equipment.
TheproductisdesignedtocomplywithIEC60601requirements.ItisaprotectionclassI, type CF device.
TheproductcomplieswiththeelectromagneticimmunityrequirementsofstandardIEC 60601-1-2/EN
60601-1-2 Electromagnetic Compatibility Medical Electrical Equipment. Theradio-
interferenceemittedbythisdeviceiswithinthelimitsspecifiedin CISPR11/EN55011, class B.
Thismanualcontainsserviceinformation;operatinginstructionsareprovidedintheuser 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. 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. Information YM412i
Service Manual11 2. Safety Information It is strongly recommended that the user first review this
document thoroughly before operating the system.
Warning:WhenoperatingthecardiographonACpower,ensurethatthe cardiograph and all other
electrical equipment connected to or near the patient are effectively grounded.
Warning:Useonlygroundedpowercords(three-wirepowercordswith grounded plugs) and grounded
electrical outlets. Warning:If asafegroundconnectionisnot ensured,operatethe 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:TheMedianapatientcable(suppliedwiththecardiograph)isan integral part of the
cardiograph safety features. Use of any other patient cable
maycompromisedefibrillationprotectionanddegradecardiograph performance.
Warning:Onlyqualifiedpersonnelmayservicethecardiographormayopen
thecardiographhousingtoaccessinternalcardiographcomponents.Donot open any covers on the
cardiograph. All internal components must be serviced by qualified personnel.
Warning:Donotusethiscardiographnearflammableanesthetics.Itisnot intended for use in explosive
environments or in operating rooms. Information 12YM412i Service Manual
Warning:Donottouchthepatient,patientcable,orcardiographduring 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:Forcontinuedprotectionagainstriskoffire,replaceonlywithsame type and rating of fuse.
Caution:Ifinternalbatterycablehasbeendisconnected,payparticular attention to polarity of the cable
before reattaching. If battery cable polarity is reversed, it is likely that circuit damage will occur.
Introduction YM412i Service Manual13 Chapter 2. Introduction Introduction 14YM412i Service
Manual 1. Device description
ThepurposeandfunctionofYM412iproductistodiagnoseelectrocardiogram,whichis
designedforeasyoperation.ECGwaveformsaredisplayedonthegraphicLCD,andthe displayed
waveforms can be printed with the built-in thermal printer. Also the YM412i product
canbeconnectedtoapersonalcomputerbasedCardiologyInformationSystemtostore information on
patients and ECG data. Introduction YM412i Service Manual15
Thesectionshowstop,sideandrearviewsoftheYM412i.Foradditionaldetails,seethe Operators
manual. Thermal Printer Keypad Graphic LCD Figure 2-1. Top Panel Figure 2-2. Rear Panel
Figure 2-3. Right Panel Introduction 16YM412i Service Manual 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 Serial Cable 1EA
Ground Cable 1EA Operators manual 1EA Service manual 1EA NOTE: The above
pictures vary from the original in some points. Introduction YM412i Service Manual17 3.
Contacting a Mediana Service Center
TheMedianaServiceCentercanassistwithproducttroubleshootingandprovide
technicalexpertisetohelpwithanyissuewiththeYM412icardiographoranyofits accessories. TEL+82-
33-742-5400 FAX+82-33-742-5618 Introduction 18YM412i Service Manual This page is
intentionally left blank. Basic Care and Maintenance YM412i Service Manual19 Chapter 3. Basic
Care and Maintenance Basic Care and Maintenance 20YM412i Service Manual 1. Description
Thischaptercontainsinformationonbasiccardiographcareandperiodicmaintenance.If
furthertechnicalassistanceisrequired,contacttheMedianaServiceCenter.Basiccleaning and
maintenance guidelines are also included in the Cleaning and Maintenance chapter of the
YM412i Operators manual. 2. Cleaning
Warning:Donotspray,pourorspillliquidmaterialsontheproduct,
accessories,connectors,switchesorcases.Anddonotwashtheproductor the accessories with
soluble or invasive liquid. For wash the product, wipe the surface lightly with a soft cloth, soaked
with ageneral-use or non-
invasivedetergent.Whilewashing,makeitsurethatanyliquidmaterialshouldnot
infiltrateintoconnectorsorcovers.Equivalentattentionshouldbepaidtocablesand accessories. 1)
Cleaning the Cardiograph 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.
Whencleaningtheequipment,payspecialattentionsothatcleaningliquidorsomething like that may
not soak into the inside of equipment.
Caution:Whencleaning,avoidtheleadwireconnectorsandpatientcable 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-basedcleaners,Phenol-basedcleaners,Ethyleneoxide Basic Care and
Maintenance YM412i Service Manual21 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 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 Basic Care and Maintenance 22YM412i
Service Manual 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 Basic Care and Maintenance YM412i Service Manual23 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,
keepthecardiographpluggedinwhennotinuse.Ifthebatteryhasbeenfullychargedand requires
recharging after a few ECGs, consider replacing it. For optimal battery performance: 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:Repeatedunderchargingofthebatterywilldamageandreduce battery life.
Caution:Followlocalgovernmentordinancesandrecyclinginstructions regarding disposal or
recycling of device components, including batteries.
NOTE:ThecapacityofabatterywillbedecreasediftheYM412iproducthasnot
beenusedforalongtimewithoutchargingit.Ittakesaround6hourstochargea battery, and it is
necessary to discharge and charge a battery regularly for recovery to
thenormalbatterycapacity.MedianarecommendsthattheNi-MHbatteryforYM412i
productshouldbereplacedeverytwoyears.PleaserefertotheChapter6. Disassembly Guide for more
information. Basic Care and Maintenance 24YM412i Service Manual 5. Firmware Upgrade
Thissectionisforthepurposeforreloadingfirmwareinthedevicewhenthepossibilityof
corruptedfirmwareexists,orupgradingfirmwarewithanewsystemversion.TheUSB 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 ESC (ESC) and then press ENTER 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
Whenthecardiographhasreachedtheendofitsproductlife,disposeifitaccordingtolocal
ordinance.Whenanyofthecardiographaccessoriesreachtheendoftheirproductlife, dispose of these
items in accordance with local ordinances. Performance Verification and Safety Tests YM412i
Service Manual25 Chapter 4. Performance Verification and Safety Tests Performance
Verification and Safety Tests 26YM412i Service Manual 1. Description This chapter describes
the tests and inspections required to verify performance of the YM412i following a service event.
TheperformanceverificationtestsverifyproperoperationoftheYM412ifollowingaservice event. The
level of testing required corresponds to the type of service performed. 2. Test Equipment
ThefollowingtestequipmentisrequiredtoperformthecompletesetofPerformance Verification tests:
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: Worn or damaged power cord Loose or missing hardware Mechanical damage
Evidence of liquid spill Worn printer drive gear Worn printer roller Corroded or damaged reusable
electrodes Damaged patient leads Dirt or paper residue on the thermal print head Frayed or
damaged wiring 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.Connect the cardiograph to AC power source using proper power cord. 2.Verify AC IN( ) and
Battery( ) in indicators is lit. 3.Press Power button, and then verify that the cardiograph is turned
on. 4.Verify Power ON( ) in indicator is lit. 5.After the cardiograph operates in normal mode,
disconnect the power cord. 6.Verify AC IN( ), Battery( ) indicator is off, and Power ON( ) indicator
is lit. 7.Press Power button, and then verify that the cardiograph is turned off. Performance
Verification and Safety Tests YM412i Service Manual27 Table 4-1 Top panel indicators for power
source Power ConnectionsTop 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.ConnecttheelectriccordtotheACpowersourceofthedevice,andthenconnectthe electric cord to the
external power supply.
2.WhentheACpowercordispluggedin,thebatteryautomaticallybeginstocharge.Fully charged battery
will not do change. The charging battery can be automatically charged by inputting AC power;
yellow LED onflashes 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 chargedOn ChargingFlashing OperationOff Performance
Verification and Safety Tests 28YM412i Service Manual 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:Whenthebatteryusingmorethan6months,willgraduallyreduce battery life.
1.Connect ECG simulator to the YM412i product.
2.AdjusttheECGsimulatorsothattheheartratebecomes60bpmandtheamplitude becomes 1mV.
3.ConnecttheelectriccordtotheACpowersourceofthedevice,andthenconnectthe 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 1. MENU Maintenance 2.Moveshadowbox(
)totheMaintenance,andpress(ENTER)keytoshowthe password input window. 3. Input the
password 1560, and press (Enter) to show the maintenance window. Performance Verification
and Safety Tests YM412i Service Manual29 Figure 4-1. Maintenance Menu Screen
4.ToverifyoroptimizecardiographLCDstate,usetheLCDtest.Moveshadow box( ) to LCD Test, and
press (ENTER) key to display the test screen. If something is the matter with the LCD, contact
qualified service personnel or Mediana service center. 6) Printer Test 1. MENU
Maintenance 2.Moveshadowbox( )totheMaintenance,andpress(ENTER)keytoshowthe password
input window. Performance Verification and Safety Tests 30YM412i Service Manual 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.Moveshadowbox( )toPrinterTest,andpress(ENTER)keytoprinttheprinter test page.
7.Ifsomethingisthematterwiththetestpage,cleantheprinterheader.Themethodof printer cleaning
refers to Chapter 3. Basic care and Maintenance.
8.ContactqualifiedservicepersonnelorMedianaservicecenter.ifproblempersistsafter 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; Heart rate: 60bpm Amplitude: 1mV
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:
Traceactivityforall12leads.Noiseshouldmeasurelessthan1mm,withno baseline wander. No gross
distortion of complexes or calibration pulses 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. Performance Verification and Safety Tests
YM412i Service Manual31 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.
Thetestsmaybeperformedundernormalambientconditionsoftemperature,humidityand pressure
and with line voltage. Test both Normal and Reverse polarity line connections for each test, and
record the worst- case value.
Ifagroundreferencepointisneededforthetesting,usethemetalgroundingstudinthe back of the
cardiograph. 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.ConnectthedeviceACmainsplugtotheanalyzerrecommendedbytheanalyzer 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 ThistestisincompliancewithIEC60601-
1earthleakagecurrent.Theappliedvoltagefor IEC60601-1 the voltage is 264V AC, 50-60Hz.
1.ConnectthedeviceACplugtotheelectricalsafetyanalyzerasrecommendedbythe 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
earthconductor.Foreachcondition,themeasuredleakagecurrentmustnotexceedthat indicated in
Table 4-1. Table 4-3. Earth Leakage Current Values ConditionAllowable Leakage Current
(microamps) Normal Condition500 Single Fault Condition1000 3) Leakage Current - Patient
Leakage Current ThistestisperformedaccordingtoIEC60601-
1StandardsontheClassICFtypeddevices. Patient leakage current in this test is measured from
any individual patient connection to earth (power ground). Performance Verification and Safety
Tests 32YM412i Service Manual
1.Settheelectricalsafetyanalyzerasrecommendedbytheelectricalanalyzersoperating instructions.
2.ConnectthedevicesACmainspowercordtotheelectricalanalyzerasrecommendedby the electrical
analyzers operation instructions.
3.ConnectECGtestcablebetweenECGconnectoronthedeviceandappropriateinput connector on
analyzer. Turn on the YM412i device. 4. Perform the test as recommended by analyzer operating
instructions. 5.Patientleakagecurrentismeasuredwithnormalandreversemainspolarity.Foreach
condition, the measured leakage current must not exceed that indicated in Table4-2. Table 4-4.
Patient Leakage Current Values ConditionAllowable Leakage Current (microamps) Normal
Condition10 Single Fault Condition50 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).Patientleakagecurrentisthenmeasuredfromanyindividualpatientconnectionto earth.
1.Settheelectricalsafetyanalyzerasrecommendedbytheelectricalanalyzersoperating instructions.
2.ConnectthedevicesACmainspowercordtotheelectricalanalyzerasrecommendedby the electrical
analyzers operation instructions.
3.ConnectECGtestcablebetweenECGconnectoronthedeviceandappropriateinput connector on
analyzer. Turn on the YM412i device. 4. Perform the test as recommended by analyzer operating
instructions. 5.Patientleakagecurrentismeasuredwithnormalandreversemainspolarity.Foreach
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 ConditionAllowable Leakage
Current (microamps) Normal polarity (Single Fault Condition)50 Reverse polarity (Single Fault
Condition Reverse Mains Voltage) 50 Performance Verification and Safety Tests YM412i Service
Manual33 5) Patient Auxiliary Current ThistestisperformedaccordingtoIEC60601-
1StandardsontheClassICFtypeddevices. TheappliedvoltageforIEC60601-1thevoltageis264V,50-
60Hz.Patientauxiliarycurrentis measured between each ECG test lead.
1.Settheelectricalsafetyanalyzerasrecommendedbytheelectricalanalyzersoperating instructions.
2.ConnectthedevicesACmainspowercordtotheelectricalanalyzerasrecommendedby the electrical
analyzers operation instructions. Table 4-6. Allowable Leakage Current ConditionAllowable
Leakage Current (microamps) Normal Condition10 Single Fault Condition50 Performance
Verification and Safety Tests 34YM412i Service Manual This page is intentionally left blank
Troubleshooting YM412i Service Manual35 Chapter 5. Troubleshooting Troubleshooting
36YM412i Service Manual 1. Description
ThischaptersuggeststroubleshootingtipsforproblemswithYM412i.Thebelowtableswill show the
possible problems of the device and the recommendable troubleshooting procedures. 2. Service
Technicians Onlytechnicallyqualifiedserviceoperatorscancarryoutdisassembly&adjustmentofa
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
consideredtobedefect,replaceitwithanewoneaccordingtotheChapter6Disassembly
Guide.Checkiftheerroriscorrectedafterreplacementandcarryoutallfunctionaltests.In
casetheerrorstillhappens,replacethenewPCBwiththeoriginaloneandfindanother solution as
instructed in this chapter. 4. Getting Replacement Parts
Medianaprovidestechnicalsupportandreplacementparts.Togetareplacementpart,users
cancontacttheMedianaServiceCenter,referringtotheChapter5ReplacementPartsfor part names
and numbers. 5. Troubleshooting Topics The following table lists all of the Troubleshooting topics
included in this chapter.
NOTE:Thetroubleshootingtipsinthischaptercoverthemaintroublesthatusers
possiblyencounter.Forotherproblems,notincludedinthesetroubleshootingtips, contact the Mediana
Service Center. Warning: Electrical shock hazard. Disconnect a power cord from YM412i before
attempting to open or disassemble YM412i. Troubleshooting YM412i Service Manual37 Table 5-
1 Troubleshooting Topics TopicSymptom Batteries and AC Power
1.WhenACpowercordisconnectedtothedevice,ACindicatoronthe front panel is not lit.
2.PowerisnotonwhenpressingthePOWERbuttoninconditionthe 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. Display 1.Screen is totally black color or white color (no data is visible)
when the power is turned on. 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 1.Buttons do not respond. 2.Some of buttons do not work tough the
power is turned on. Beep1. Audible beep does no sound. Printer
1.Printerdoesnotresponseeventhoughprintingrelatedbuttonsare pressed.
2.Printergeneratesemptypaperevenincasetheprintermotorworks and the printing paper is loaded.
Other 1. One lead signal or more come out in straight lines or too much noise is generated. 2.
One leads signal or more come out in straight lines or too much noise is generated.
Troubleshooting 38YM412i Service Manual 6. Battery and AC Power
ThefollowingtabledescribescommonproblemswithbatteriesandACpower.Iftheaction requires
replacement of the components, refer to [Chapter 6. Disassembly Guide]. Table 5-2 Battery and
AC Power Troubleshooting SymptomSolution 1.WhenACpowercordis connected to the device,
AC indicatoronthefrontpanel is not lit. 1-1 Ensure power cord is plugged into the appropriate AC
outlet of voltage and frequency. 1-2 Replace the AC fuse. 1-3 Check the main cable and ensure
that it is connected to the main board and the power module. 1-4 If indicator is not lit, replace the
main cable. 1-5 If the problem persists, replace the power module. 1-
6Iftheproblempersists,ensurethekeypadcableis
connectedtothekeypadassemblyandthemainboard.If connection is good, replace the keypad.
2.Powerisnotonwhen pressingthePOWER buttoninconditionthe externalACpowerlineis
connected to the device. 2-1 Ensure power cord is plugged into the appropriate AC outlet of
voltage and frequency. 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-
5Ensurethekeypadisconnectedtothemainboard.If connection is good, replace the keypad. 2-6 If
the problem persists, replace the main board. 3.Thedevicedoesnot operatewhendisconnected
from AC power. 3-1Thebatterymaybedischarged.Torechargethebattery, connect a power cord to
AC mains over 6hours. 3-2 Check the main cable and ensure that it is connected to the main
board and the power module. 3-3Thebatterymaybeoverheated.Afterithasdropped, operate the
device. 3-4 If the problem persists, replace the battery. 3-5 If the problem persists, replace the
main board. Troubleshooting YM412i Service Manual39 4. Battery does not charge. 4-
1Ensurethekeypadisconnectedtothemainboard.If connection is good, replace the keypad. 4-2 If
the battery fails to hold a charge, replace the battery. 4-
3VerifytheACINLEDislit,whileonAC.Whilecharging
battery,theBatteryLEDisflasheduntilbatterychargingis completed. When the battery charging is
completed, the Battery LEDislitcontinuously.ReplacethepowermoduleiftheLEDs are not lit.
Troubleshooting 40YM412i Service Manual 7. Display
Thefollowingsaresymptomsofproblemsrelatingtonon-functioningdisplays,and recommended
action. If the action requires replacement of a PCB assembly or module, refer to Chapter 6.
Table 5-3 Display Troubleshooting SymptomSolution 1.Screenistotallyblackor
whitecolor(nodatais visible)whenthepoweris turned on. 1-1 Check the backlight cable and the
data cable are connected to the STN-SUB PCB. 1-2ChecktheSTN-
SUBPCBconnectorisconnectedtothe main PCB 1-3 If problem persists, replace the STN-SUB
PCB. 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. 2. Data (signal & text) is not
showneventhoughthe screen is normal. 2-1 Check the backlight cable and the data cable are
connected to the STN-SUB PCB. 2-2ChecktheSTN-SUBPCBconnectorisconnectedtothe main
PCB 2-3 If problem persists, replace the STN-SUB PCB. 2-4 If problem persists, replace the
CPU module. 2-5 If problem persists, replace the LCD module. 2-6 If problem persists, replace
the main board. 3.Backlightisnotactivated whiledataisdisplayedon the screen. 3-1 Check the
backlight cable and the data cable are connected to the STN-SUB PCB. 3-2ChecktheSTN-
SUBPCBconnectorisconnectedtothe main PCB 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.Displayvaluesare missing or erratic. 4-
1Ifthepatientcablesareconnected,ensurethatthecables are properly connected. 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. 4-5 If problem persists, replace the LCD
module. 4-6 If problem persists, replace the main board. Troubleshooting YM412i Service
Manual41 8. Button
Thefollowingisasymptomofproblemsandrecommendedactionsrelatingtobuttons.Ifthe action
requires replacement of a PCB assembly, refer to Chapter 6. Table 5-4 Button Troubleshooting
SymptomSolution 1. Buttons do not respond. 1-1 Check the keypad is properly connected to the
main board. 1-2 Check the cable between main board and the keypad PCB. 1-3 If the cable
abnormal, replace the cable. 1-4 If problem persists, replace the keypad PCB. 1-5 If problem
persists, replace the main board. 2.Someofbuttonsdonot worktoughthepoweris turned on. 2-1
Check the keypad is properly connected to the main PCB. 2-2 Check the cable between main
board and the keypad PCB. 2-3 If the cable abnormal, replace the cable. 2-4 If problem persists,
replace the keypad PCB. 2-5 If problem persists, replace the main PCB. 9. Beep
Thefollowingisasymptomofproblemsandrecommendedactionsrelatingtobeep.Ifthe action requires
replacement of a PCB assembly, refer to Chapter 6. Table 5-5 Beep Troubleshooting
SymptomSolution 1.Audiblebeepdoesno sound. 1-1 Check beep silence status. 1-2 Check beep
setting in system setup menu. 1-3Checkthemaincablebetweenmainboardandthepower module.
1-4 If problem persists, replace the main board. Troubleshooting 42YM412i Service Manual 10.
Printer Thefollowingisasymptomofproblemsandrecommendedactionsrelatingtoprinter.Ifthe action
requires replacement of a PCB assembly, refer to Chapter 6. Table 5-6 Printer Troubleshooting
SymptomSolution 1. Printer does not response eventhoughprintingrelated buttons are pressed.
1-1Opentheprintercoverandcheckifthepaperisproperly loaded. 1-2 Check the printer related
connections are properly secured. 1-3 The printer header may be overheated. After it has
dropped, operate the device. 1-4 If problem persists, replace the printer module. 1-5 If problem
persists, replace the main board. 2.Printergeneratesempty paperevenincasethe
printermotorworksandthe printing paper is loaded. 2-
1Opentheprintercoverandcheckthepaperisproperly 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. 2-3 If problem persists, replace the main board. Troubleshooting YM412i Service
Manual43 11. Others Table 5-7 Others SymptomSolution 1.Oneleadsignalormore
comeoutinstraightlinesor toomuchnoiseis generated. 1-1 Check the patient cable is properly
connected to the device. 1-2 Check the filters are properly setting. 1-3 If problem persists,
replace the patient cable. 1-4 if problem persists, replace the main board. 2. Leads II and III2-1
Check LL(or F) and RL(or N) lead wire and electrode. 3. Leads I and III3-1 Check LA(or L) and
RL(or N) lead wire and electrode. 4. Leads I and II4-1 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.
Troubleshooting 44YM412i Service Manual This page is intentionally left blank. Disassembly
Guide YM412i Service Manual45 Chapter 6. Disassembly Guide Disassembly Guide 46YM412i
Service Manual 1. Description This chapter contains information on removing and replacing the
YM412i components. Caution:DonotoperatetheYM412iproductrightafterrepairorexamination.
Operatethedeviceaftercompletingallofthefunctionaltestsandsafety inspections described in the
Chapter 3. Failure in the functional test may cause misreading. The following parts of the YM412i
product can be disassembled. PCB Battery Cables Printer Case The following tools are used for
disassembly. Screwdriver (manual or automatic) Needle - Nose Pliers Torque
Warning:Electricalshockhazard.Besuretodisconnectthemainpower supply from the device before
disassembling the YM412i product. Warning:Ahigh-
voltagecanbegeneratedfromtheLCDbacklightdriver.Be careful when opening the cover.
Caution:Incasetheinternalbatterycableisnotconnected,specialattention
shouldbepaidtothepolarityofthepowersupply.Ifthepolarityisreversed, the circuits may be damaged.
NOTE:Togetmainreplacementparts,contacttheheadofficeofMedianaService Center. Disassembly
Guide YM412i Service Manual47 2. How to Use Disassembly Guide
Warning:Beforeattemptingtoopenordisassembletheelectrocardiograph, disconnect the power
cord from the electrocardiograph.
Caution:ObserveESD(electrostaticdischarge)precautionswhenworking 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
fromthelowercaseassembly.Forthelistofreplaceableparts,refertotheChapter7 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
ThebelowdisassemblychartisavailableonlyfortheYM412iproduct.Andthechartis prepared for the
qualified service operators approved by Mediana, which is composed in direct manner for
troubleshooting. Figure 6-1. Disassembly Flow Chart Disassembly Guide 48YM412i Service
Manual Figure 6-2. Upper Case Disassembly Disassembly Guide YM412i Service Manual49
Main PCB Power Module Detach the cable between main PCB and power module. Detach the
cable between main PCB and power module. Lower Case Battery Printer Remove screws from
battery bracket Remove screws from printer Detach connectors from PCB Detach battery bracket
Remove screws from power module Remove screws from PCB. Remove ground terminal from
case. CPU Module Detach CPU Module Cap Detach the CPU Module from Main PCB Figure 6-
3. Lower Case Disassembly Disassembly Guide 50YM412i Service Manual 4. Disassembling
Cases Thischaptershowsthedisassemblyprocedures,throughpictures,forreplacementofthe
assembliesorthepartsoftheYM412iproductthatareconsideredtobedefectordamaged. Some of the
explanatory procedures contain pictures of the replacement parts. 5. Opening the device
ToopentheYM412ireleasethe4fasteningscrews(M3x8)ontheundersideofthedevice, carefully raise
the upper shell of the housing, disconnect keypad and LCD cable. Figure 6-4 Detaching the
Upper and Lower case Disassembly Guide YM412i Service Manual51 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 Disassembly
Guide 52YM412i Service Manual 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 Disassembly Guide YM412i Service
Manual53 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 Disassembly Guide 54YM412i Service Manual
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 Disassembly Guide YM412i Service Manual55 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 Disassembly Guide 56YM412i Service
Manual Table 6-1. Part Descriptions Lower Case Assembly Part CodesDescriptionsQty
E00000-00Battery1 M05210-00Battery Bracket1 E50000-00Printer1 P05201-00Main Board1
P05202-00CPU Module1 M05211-00CPU Module Cap1 E41101-00Power Module1 -Screw23
Disassembly Guide YM412i Service Manual57 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 Disassembly Guide 58YM412i Service Manual 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 Disassembly
Guide YM412i Service Manual59 Table 6-2. Part Descriptions Upper Case Assembly Part
CodesDescriptionsQty P05203-00Keypad PCB1 H05212-00Cable between keypad PCB and
main board1 E20001-00LCD1 P05204-00STN-SUB PCB1 H05211-00Cable between STN-SUB
PCB and main board2 -Screw12 Disassembly Guide 60YM412i Service Manual 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 Main PCBKeypad PCB J5J9 ColorDescription 11RedKey
column 3 22GrayKey row3 33GrayKey column 2 44GrayKey row2 55GrayKey column 1
66GreenKey row1 77GrayKey column 0 88GrayKey row0 99GrayGND 1010GrayGND
1111GreenPower ON/OFF Key 1212GraySMPS Standby power 1313GrayAC power check
indicator 1414GrayGND 1515GrayBattery charge indicator 1616GreenPower ON Indicator
Disassembly Guide YM412i Service Manual61 Table 6-4. Main PCB to STN-SUB PCB Data
Cable Main PCBSTN SUB PCB J10J13 ColorDescription 11Red+5V VDD 22GrayBack light unit
Power 33GrayGND 44GrayGND 55GrayVSYNC 66GreenVideo Data 0 77GrayVDE
88GrayVideo Data 1 99GrayHSYNC 1010GrayVideo Data 2 1111GreenVCLK 1212GrayVideo
Data 3 1313GrayLCD Enable 1414GrayGND 1515GrayGND 1616GreenContrast control
1717Gray-20V STN 1818GrayGND 1919GrayGND 2020GrayGND Table 6-5. STN SUB PCB to
LCD Back Light Cable STN SUB PCBLCD BLU J2LCD Description 11GND 22N.C 33N.C 44OUT
Disassembly Guide 62YM412i Service Manual Table 6-6. Main PCB to Printer Unit Head Cable
Main PCBPrinter unit PJ5Head Description 1, 21,221, 21,2211V Header power 22NC 33Header
data Latch signal. 44Header CLK 555V VDD 66Strobe signal 1 7,87,8Strobe signal 2 99Header
thermistor 10,11,12,13,14,1510,11,12,13,14,15 GND 16,1716,17Strobe signal 2
18,1918,19Strobe signal 2 2020Data Table 6-7. Main PCB to Printer Unit Motor Film Cable Main
PCBPrinter unit PJ2Motor Description 11Phase A 22Phase negative A 33Phase B 44Phase
negative B Table 6-8. Main PCB to Printer Unit Motor Film Cable Main PCBPrinter unit PJ2Paper
Sensor Description 11Phase A 22Bias 33Sensor out 44GND Disassembly Guide YM412i Service
Manual63 Table 6-9. Main PCB to SMPS Module Cable Main PCBSMPS WJ2CJ3
ColorDescription 11RedBATT Level Signal 22GrayBattery charging status signal 33GrayAc
check signal 44GrayMain DC/DC ON/OFF Signal 55GrayGND 66GreenSMPS Standby 16V
77GraySTN Negative Power 88GraySTN Negative Power 99GrayGND 1010GrayGND
1111GreenThermal Printer Header VCC 1212GrayThermal Printer Header VCC 1313GrayGND
1414GrayGND 1515GrayThermal printer Motor VCC 1616GreenThermal printer Motor VCC
1717GrayGND 1818GrayGND 1919Gray5V 2020Gray5V Table 6-10. SMPS to Battery Cable
SMPSBattery CN2 ColorDescription 1+RedBattery( +) 2TBlueThermistor 3-BlackBattery(-) Table
6-11. SMPS to Battery Cable SMPSGNDColorDescription Power inlet earth terminal GND
TerminalGreen & YellowGND Disassembly Guide 64YM412i Service Manual This Page is
intentionally left blank. Parts List YM412i Service Manual65 Chapter 7. Parts List Part List
66YM412i Service Manual 1. Description
Thischapterprovidesinformationonorderingreplacementparts,supplies,andaccessoriesfortheYM41
2icardiograph.Toorderreplacement parts, contact Mediana Service Center. Figure 7-1. YM412i
Parts Parts List YM412i Service Manual67 Table 7-1. YM412i Part List No.Part CodesDescription
1L05203-00Keypad Overlay 2L05202-00LCD Overlay 3C05250-00Thermal Printer Cover
4E60000-00Thermal Printer Roller 5C05210-00Upper Case 6E20001-00LCD 7P05203-
00Keypad 8P05204-00STN-SUB PCB 9M05210-00Battery Bracket 10E00000-00Battery
11E50000-00Thermal Printer Body 12P05201-00Main Board 13E41101-00Power Module
14M05200-00GND Terminal 15-GND Washer 16-GND Nut 17C05211-00Lower Case
18M05211-00CPU Module Cap Part List 68YM412i Service Manual This Page is intentionally left
blank. Packing YM412i Service Manual69 Chapter 8. Packing Packing 70YM412i Service
Manual 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
Thestandardcartonboxpackingishighlyrecommendedifavailable,andthepacking 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.Prepare a box with a proper size. 2.Reinforce the lower
side of the box with packing tapes. 3.Place the box containing accessories on the center of
bottom of the packing box. 4.Fill the empty space of the both sides of the accessory box with
buffing material. 5.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. Specifications YM412i Service Manual71
Chapter 9. Specifications Specification 72YM412i Service Manual Display Type103mm(W) X
77.22mm(H) STN mono LCD Resolution320 X 240 dots Computerized Electrocardiograph ECG
Storage Basic - 100 ECGs (typical) Option 5000 cases in SD Card (1GB) Pre-
acquisitionProvides 10s of instantaneous ECG acquisition Dynamic Range AC differential: 5mV
DC offset: 300mV Sampling Rate500Hz Frequency Response0.05 to 150Hz CommonMode
Rejection 100dB Input Impedance> 50 PatientLeakage Current < 10 CommunicationPC
communication with RS232 interface and LAN Firmware UploadUse the USB memory stick Filter
AC: 50/60Hz Low Pass Filter: 40, 100, 150Hz Baseline Filter: 0.5Hz Muscle Filter Writer
TypeThermal dot array Speeds5, 10, 25, 50mm/sec Numbers of Traces3, 6 or 12 user-selectable
Sensitivity/Gain5, 10, 20mm/mV Speed Accuracy5% Amplitude Accuracy5% Paper
Type/SizeThermal Roll, 110mm X 30m Specifications YM412i Service Manual73 Electrical
Power SupplyAC or Battery operation AC Input100-240VAC 50/60Hz, 70VA FusesQty. 2,
250Vac T6.3AL, IEC(5x20mm) Battery Type 12V 3.8Ah, Rechargeable Nickel Metal Hydride
Cylindrical Cell Battery Capacity 150basicreports(AutoMode)or5hourscontinuous operation
(without printing) Battery Charge TimeApproximately 6hours from total discharge Physical
Dimension351 X 268.5 X 63 (W x L x H) mm Weight2.7Kg (including battery) without paper
Environmental Operating Conditions Temperature range 10-45 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 ClassificationClass I, Internally powered Type of protectionType CF
with defibrillation protection Mode of operationContinuous Degree of protectionIPX 0 93/42/EEC
Directives for medical devices ISO9001:2000QualityManagementSystems- Requirements
ISO13485:2003Medicaldevices-Qualitymanagement systems - Requirements regulatory
purposes General ISO14971:2000Medicaldevices-Applicationofrisk management to medical
devices Specification 74YM412i Service Manual IEC60601-1:1988+A1:1991+A2:1995General
requirements for Safety IEC60601-1-4:1996+A1:1999GeneralRequirementsfor
safetycollateralstandard:programmableelectrical medical systems ISO10993-
1:2003Biologicalevaluationofmedical devices Part 1: Evaluation and testing Electrocardiograph
IEC60601-2-25:1993+A1:1999 Particular requirements for the safety of electrocardiographs
IEC60601, sub clause 36 IEC60601-1-2:2001+A1:2004Electromagnetic compatibility -
Requirements and tests IEC61000-3-2:2000 Harmonic current emissions IEC61000-3-
3:1995+A1:2001Voltagefluctuations/Flicker Emissions IEC61000-4-
2:1995+A1:1998+A2:2001Electrostatic Discharge(ESD) IEC61000-4-
3:2002+A12002RadiatedRF electromagnetic field IEC61000-4-4:2004 Electrical fast
transient/burst IEC61000-4-5:1995+A1:2001 Surge current IEC61000-4-
6:1996+A1:2001Conducteddisturbances, induced by RF field IEC61000-4-
8:1993+A1:2001Powerfrequency(50/60Hz) magnetic field IEC61000-4-
11:1994+A1:2001Voltagedips,short interruptionandvoltagevariationonpowersupplyinput lines
Electromagnetic Compatibility CISPR11(EN55011) RF Emissions Group 1, Class B Labeling
EN1041:1998Informationsuppliedbythemanufacturer with medical devices Marking
EN980:2003Graphicalsymbolsforuseinthelabelingof medical devices Functional Description
YM412i Service Manual75 Chapter 10. Functional Description Functional Description 76YM412i
Service Manual 1. Description
ThischapterprovidesfunctionaldescriptionsofthecomponentsoftheYM412iCardiograph. These
descriptions are at the functional-block level. 2. System Overview
TheYM412isystemperformsacquisition,analysis,printing,storage,andtransferofECG waveforms
and other patient clinical data. 3. Hardware Functional View
ControloftheYM412iisprovidedbyapplicationsoftwarerunningonthemaincontrolboard,
interactingwithnumeroushardwareandsoftwaresubsystems.Thefollowingarehigh-level descriptions
of these various subsystems. The hardware consists of the following function blocks: 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 Functional Description YM412i Service Manual77 1) Power System The
YM412i power system contains the power module and battery. ApowermoduleconsistsofAC-
DCConverter(AC/DC),DC-DCConverter(DC/DC)and Battery Charger. Battery Pack Ni-MH 1.2V
3800mAh 10Cell FUSE FUSEAC/DC Switching Power Supply 16V Charger with Charger
Management MCU Indication LED DC/DC (Main Power) C O N ON/OFF Relay DC/DC (Thermal
Printer Motor) DC/DC (Thermal Printer Header) DC/DC (LCDNegative power) F U S E Connector
Connector Main Board P o w e r C o n t r o l S i g n a l AC Line Power F I L T E R A C I n l e t
Figure 10-2. Power System Block Diagram 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. Functional Description 78YM412i Service Manual 2) DC Power Supply
YM412iprovidesthepowertoeachcircuitpartthroughthepowersystemlikethefollowing block diagram.
Figure 10-3. DC Power Supply Block Diagram 16V Stand by Supply the 16V for power
management unit. YM412i maintain the ready. +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.
+8.5V Thermal Printer Header Operation of the thermal printer header +7.5V Thermal Printer
Motor Operation of the thermal printer motor -20V STN LCD Negative Power Operation of the
STN LCD Functional Description YM412i Service Manual79 3) Main CPU Module
MainCPUModulecontainstheprocessorS3C2440A,NORFlash,SDRAMandallsortsof 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 Functional Description 80YM412i Service
Manual 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
YM412iconsistofmultifunctionkeysoftennumberkeys(hotkeys)andsixfunctionkeys (direction keys).
And keypad includes power on/off key and three indicators. S 3 C 2 4 4 0 A Figure 10-7. Keypad
Interface Block Diagram Functional Description YM412i Service Manual81 7) Thermal Printer
Interface ThermalPrinterconsistsofThermalheaderandstepmotor.Eachdatacontrolledbymain
processor and timing adjusted by CPLD and FIFO. Thermal Printer Header Thermal Printer
Motor Logic Buffer Data Bus & Control Signal GPIO STB1 STB2 STB3 STB4 Data Bus IO
Control LAT DATA CLK Motor Phase Motor Driver CPLD FIFO Con. Sig. Data Con. Sig. Figure
10-8. Thermal Printer Interface Block Diagram 8) Communication Interface
YM412ihaveinterfacemethodsoftheUARTserial,TCP/IPandUSBcommunication.Great capacity
data can backup using the internal SD card (optional). SPI Data Bus TCP/IP Stack Con. Sig.
Data& ADD. BUS LAN Connector 10/100 T Interface Eternet Phyceiver UART USB RS-232
Driver Serial UART SD CARD USB HOST Figure 10-9. Communication Interface Block Diagram
Functional Description 82YM412i Service Manual 9) Analog Signal Acquisition Interface
Acquisition data digitized by AD converter and then transfer to main processor. RL Driver
Saturation Detecter Discharger +5V TX RX GPIO UART Isolation barrier +5V -5V Figure 10-10.
Analog Signal Acquisition Interface Block Diagram