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...15Figure 2-2. Rear
Panel.15Figure 2-3. Right Panel15Figure 3-1. Cleaning the printer
head..21Figure 3-2. Changing Printer Paper..22Figure 3-3. Firmware
upgrading Screen.24Figure 4-1. Maintenance Menu
Screen...............................................................................29Figure
6-1. Disassembly Flow Chart47Figure 6-2. Upper Case
Disassembly..48Figure 6-3. Lower Case Disassembly.49Figure 6-4
Detach the Upper and Lower case..50Figure 6-5 Battery
Disassembly51Figure 6-6 Thermal Printer Disassembly52Figure 6-7
Main Board Disassembly53Figure 6-8 Fuses replacement53Figure 6-9
Power Module Disassembly..54Figure 6-10 Replacing the CPU
Module..55Figure 6-11. Keypad Disassembly57Figure 6-12. LCD and
STN-SUB PCB Disassembly.58Figure 7-1. YM412i Parts.66Figure 10-1.
Block Diagram of Entire instrument.76Figure 10-2. Power System
Block Diagram77Figure 10-3. DC Power Supply Block Diagram.78Figure
10-4. Main CPU Module Block Diagram.79Figure 10-5. RTC Power
Interface Block Diagram79Figure 10-6. Display Interface Block
Diagram..80Figure 10-7. Keypad Interface Block Diagram..80Figure
10-8. Thermal Printer Interface Block Diagram81Figure 10-9.
Communication Interface Block Diagram..81Figure 10-10. Analog
Signal Acquisition Interface Block Diagram.82 Tables Table 2-1.
List of Components.16Table 4-1 Top panel indicators for power
source27Table 4-2 Battery Charging Status Indications27Table 4-3.
Earth Leakage Current Values..31Table 4-4. Patient Leakage Current
Values..32Table 4-5. Patient Leakage Current Values-Mains Voltage
on Applied Part.32Table 4-6. Allowable Leakage Current33Table 5-1
Troubleshooting Topics...37Table 5-2 Battery and AC Power
Troubleshooting.38Table 5-3 Display Troubleshooting.40Table 5-4
Button Troubleshooting..41Table 5-5 Beep Troubleshooting..41Table
5-6 Printer Troubleshooting..42Table 5-7 Others...43Table 6-1. Part
Descriptions Lower Case Assembly...56Table 6-2. Part Descriptions
Upper Case Assembly...59Table 6-3. Main PCB to Keypad PCB
Cable..60Table 6-4. Main PCB to STN-SUB PCB Data Cable.61Table 6-5.
STN SUB PCB to LCD Back Light Cable61Table 6-6. Main PCB to Printer
Unit Head Cable.62Table 6-7. Main PCB to Printer Unit Motor Film
Cable..62Table 6-8. Main PCB to Printer Unit Motor Film
Cable..62Table 6-9. Main PCB to SMPS Module Cable63Table 6-10. SMPS
to Battery Cable.63Table 6-11. SMPS to Battery Cable.63Table 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. ThermalPrinterKeypadGraphicLCD 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 ENTERRUN(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 blankTroubleshooting 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 PCBPower ModuleDetach the cable between main PCB and
power module.Detach the cable between main PCB and power
module.Lower CaseBatteryPrinterRemove screws from battery
bracketRemove screws from printerDetach connectors from PCBDetach
battery bracketRemove screws from power moduleRemove screws from
PCB.Remove ground terminal from case.CPU ModuleDetach CPU Module
CapDetach 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,andaccessoriesfortheYM412icardiograph.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 PackNi-MH 1.2V 3800mAh
10CellFUSEFUSEAC/DCSwitchingPower Supply16VCharger with Charger
Management MCUIndication LED DC/DC(Main Power)CONON/OFFRelay
DC/DC(Thermal Printer Motor)DC/DC(Thermal Printer
Header)DC/DC(LCDNegative power)FUSEConnectorConnectorMain
BoardPowerControl SignalACLine PowerFILTERAC Inlet 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. S3C2440A 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
HeaderThermal Printer MotorLogic BufferData Bus& Control
SignalGPIOSTB1STB2STB3STB4Data BusIO
ControlLATDATACLKMotorPhaseMotor DriverCPLD FIFOCon. Sig.DataCon.
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).
SPIData BusTCP/IPStackCon. Sig.Data& ADD. BUSLAN
Connector10/100 T
InterfaceEternetPhyceiverUARTUSBRS-232DriverSerial UARTSD CARDUSB
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 DriverSaturation
DetecterDischarger+5VTXRXGPIOUARTIsolation barrier+5V-5V Figure
10-10. Analog Signal Acquisition Interface Block Diagram
