BeneHeart R12-BeneHeart R12A Service Manual

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BeneHeart R12/BeneHeart R12ABeneHeart R12/BeneHeart R12A
ElectrocardiographElectrocardiograph
Service ManualService Manual
  
  
II
Intellectual Property Intellectual Property StatementStatement
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns the intellectual propertySHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns the intellectual property
rights to this rights to this product and this product and this manual. This manual may refer to information protected by copyrights or patents andmanual. This manual may refer to information protected by copyrights or patents and
does not convey any license under the patent rights of Mindray, nor the rights of others. Mindray does not assume anydoes not convey any license under the patent rights of Mindray, nor the rights of others. Mindray does not assume any
liability arising out of liability arising out of any infringementany infringements of patents or s of patents or other rights of third parties.other rights of third parties.
, , , , and and are are the the registered registered trademarks trademarks or or trademarks trademarks owned owned by by Mindray Mindray in in ChinaChina
and other and other countries.countries.
Revision HistoryRevision History
 This manual has a r This manual has a revision numberevision number. This re. This revision number cvision number changes whenehanges whenever the mver the manual is updated anual is updated due to softwardue to software ore or
technical specification change. Contents of this manual technical specification change. Contents of this manual are subject to change are subject to change without prior notice.without prior notice.
   Version Version number number 2.02.0
   Release Release time: time: October October 20142014
© 2013-2014 © 2013-2014 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved.rights reserved.
  
  
IIII
PrefacePreface
Manual PurposeManual Purpose
 This manual pro This manual provides detailed vides detailed information information about the assemabout the assembling, dissemblingbling, dissembling, testing and t, testing and troubleshootroubleshooting of theing of the
equipment to support effective troubleshooting and repair. It is not equipment to support effective troubleshooting and repair. It is not intended to be a intended to be a comprecomprehensive, in-depthhensive, in-depth
explanation of the product architecture or technical implementation. Observance of the explanation of the product architecture or technical implementation. Observance of the manual is a manual is a prereqprerequisite foruisite for
proper equipment maintenance and prevents equipment damage and personnel injury.proper equipment maintenance and prevents equipment damage and personnel injury.
Intended AudienceIntended Audience
 This manual is for  This manual is for biomedical engbiomedical engineers, authineers, authorized techorized technicians or service rnicians or service representativepresentatives responsible fes responsible foror
troubleshoottroubleshooting, repairing and ing, repairing and maintaining the equipment.maintaining the equipment.
  
  
11
ContentsContents
1 1 General General ..............................................................................................................................................................................................................................................................................................................................................................1-11-1  
1.1 Revision History ....................................................................................................1.1 Revision History .................................................................................................... .............................................................................................................................................. .................... .................... 1-11-1  
1.2 Safety Information ........................................................................................................................1.2 Safety Information ........................................................................................................................ .............................................................................................................................. ... ... 1-21-2  
1.2.1 Warnings 1.2.1 Warnings .................................................................................................................... .................................................................................................................................... .............................................................................................................................. .... .... 1-21-2  
1.2.2 Cautions 1.2.2 Cautions .......................................................................................................................... .................................................................................................................................. ............................................................................................................................ .... .... 1-31-3  
1.2.3 Notes .........................................................................................................................1.2.3 Notes ......................................................................................................................... ........................................................................................................................................ ......... ......... 1-31-3  
1.3 Equipment Symbols .....................................................................................................................1.3 Equipment Symbols ..................................................................................................................... ............................................................................................................................ .... .... 1-41-4  
2 2 Theory Theory of of Operation Operation ....................................................................................................................................................................................................................................................................................................................2-12-1  
2.1 Introduction 2.1 Introduction ................................................................................................................ .................................................................................................................................. .............................................................................................................................. .............. .............. 2-12-1  
2.2 Device 2.2 Device Connector Connector ...................................................................................................................................... ........................................................................................................................................ ..................................................... 2-2..................................................... 2-2  
2.2.1 Back View2.2.1 Back View.............................................................................................................................................................................................. 2-2.............................................................................................................................................................................................. 2-2  
2.3 Main Unit 2.3 Main Unit .............................................................................................................................................................................................................................................................. .............................................................................................................................. .............. .............. 2-32-3  
2.3.1 Top Cover Assembly .......................................................................................................2.3.1 Top Cover Assembly ....................................................................................................... .................................................................. 2-4.................................................................. 2-4  
2.3.22.3.2  Middle Frame Assembly .......................................................................................................Middle Frame Assembly ....................................................................................................... ......................................................... 2-4......................................................... 2-4  
3 3 Unpacking Unpacking and and Installation .................Installation .............................................................................................................................................................................................................................................................................3-13-1  
3.1 Unpacking the Equipment ............................................................................................3.1 Unpacking the Equipment ............................................................................................ ........................................................................................................................................ .......... .......... 3-13-1  
3.2 Preparation for Installation ..................................................................................................................3.2 Preparation for Installation .................................................................................................................. ........................................................ 3-1........................................................ 3-1  
3.2.1 3.2.1 EnvironmEnvironmental Requirements ental Requirements .............................................................................................................. ............................................................................................................................ .................................. 3-1.................................. 3-1  
3.2.2 Checking 3.2.2 Checking Paper TPaper Tray Size ...................................................................................................................ray Size ................................................................................................................... ............................................. 3-2............................................. 3-2  
3.3 Turning On the 3.3 Turning On the Equipment Equipment .................................................................................................................................. .................................................................................................................................................. ................................ ................................ 3-23-2  
4 4 Hardware Hardware and and Software Software Upgrade ...................Upgrade .................................................................................................................................................................................................................................................. 4-1..... 4-1  
4.1 Hardware Upgrade 4.1 Hardware Upgrade ............................................................................................................ .................................................................................................................................. .............................................................................................................................. ... ... 4-14-1  
4.1.1 Upgrading the Equipment to have Wi-Fi Function ...............................................................................................................4.1.1 Upgrading the Equipment to have Wi-Fi Function ...............................................................................................................4-14-1  
4.2 Software Upgrade 4.2 Software Upgrade ................................................................................................................ .................................................................................................................................. ............................................................................................................................ .... .... 4-14-1  
4.2.1 Installing 4.2.1 Installing Software Upgrade TSoftware Upgrade Tool ...............................................................................................................ool ............................................................................................................... ................................. ................................. 4-24-2  
4.2.2 Software Upgrade Procedure ..................................................................................4.2.2 Software Upgrade Procedure .................................................................................. .................................................................................................................................... ... ... 4-44-4  
5 5 TTesting esting and and Maintenance Maintenance ....................................................................................................................................................................................................................................................................................................5-15-1  
5.1 Introduction 5.1 Introduction ................................................................................................................ .................................................................................................................................. .............................................................................................................................. .............. .............. 5-15-1  
5.1.1 Testing Too5.1.1 Testing Tool ..................................................................................l .................................................................................. .......................................................................................................................................... ................................... 5-1................................... 5-1  
5.1.2 Test Report 5.1.2 Test Report ................................................................................................................ .................................................................................................................................. .............................................................................................................................. ... ... 5-15-1  
5.1.3 5.1.3 PrevPreventative Maintenance .....................................................................................................entative Maintenance ..................................................................................................... ........................................................ 5-1........................................................ 5-1  
5.1.4 Recommended Freque5.1.4 Recommended Frequency ..........................ncy .......................... .................................................................................................................... ............................................................................................................................................. ... 5-25-2  
5.2 Visual Inspection5.2 Visual Inspection.............................................................................................................................................................................................. 5-2.............................................................................................................................................................................................. 5-2  
5.3 Power-on T5.3 Power-on Test ....................................................................est .................................................................... ........................................................................................................................ .............................................................................................................................. .... .... 5-25-2  
5.4 5.4 ECG Performance TECG Performance Test est ................................................................................................................................ ............................................................................................................................ ...................................................... 5-3...................................................... 5-3  
5.5 Battery Check 5.5 Battery Check ........................................................................................................................ .......................................................................................................................................... .............................................................................................................................. .... .... 5-35-3  
5.6 Factory Maintenance .....................................................................................................................5.6 Factory Maintenance ..................................................................................................................... ................................................................ ................................................................ 5-45-4  
5.7 Electrical Safety Tests ...................................................................................................................5.7 Electrical Safety Tests ................................................................................................................... .............................................................................................................................. ... ... 5-45-4  
  
  
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6 6 TroTroubleshooting ubleshooting ........................................................................................................................................................................................................................................................................................................................... ..... 6-16-1  
6.1 Overview ........................................................................................................................................................................................................... 6-16.1 Overview ........................................................................................................................................................................................................... 6-1  
6.2 Parts Replacement ......................................................................................................................................................................................... 6-16.2 Parts Replacement ......................................................................................................................................................................................... 6-1  
6.3 General Problem6.3 General Problems and Prompts s and Prompts ................................................................................................................ ........................................................................................................................................ .................................... 6-1.................................... 6-1  
6.4 Troubleshooting Guide ................................................................................................................................................................................ 6-26.4 Troubleshooting Guide ................................................................................................................................................................................ 6-2  
6.4.1 Power On/Off F6.4.1 Power On/Off Failure ailure ............................................................................................................ .................................................................................................................................... ............................................... 6-2............................................... 6-2  
6.4.2 Recorder Failure ................................................................................................................................................................................ 6-26.4.2 Recorder Failure ................................................................................................................................................................................ 6-2  
6.4.3 Wrong Syste6.4.3 Wrong System Time m Time .......................................................................................................... .......................................................................................................................................... ............................................... 6-3............................................... 6-3  
6.4.4 Wi-Fi Relate6.4.4 Wi-Fi Related Failurd Failures .................................................................es ................................................................. .................................................................................................................................. .................................... 6-4.................................... 6-4  
7 7 Disassembly Disassembly and and Repair ...................Repair ................................................................................................................................................................................................................................................................. 7-1.................... 7-1  
7.1 T7.1 Tools Required ools Required ............................................................................................................................ ................................................................................................................................ ................................................................... 7-1................................................................... 7-1  
7.2 Preparations for Disassembly 7.2 Preparations for Disassembly ........................................................................................................................................ ........................................................................................................................ ..................................... 7-1..................................... 7-1  
7.3 Disassembling the Main Unit ..................................................................................................................................................................... 7-27.3 Disassembling the Main Unit ..................................................................................................................................................................... 7-2  
7.3.1 Removing the Battery 7.3.1 Removing the Battery ............................................................................................................................................................................................................................................ ............................................... 7-2............................................... 7-2  
7.3.2 Removing Bottom Case Assem7.3.2 Removing Bottom Case Assembly .....................................................................................................................bly ..................................................................................................................... ........................ 7-2........................ 7-2  
7.3.3 Removing the T7.3.3 Removing the Top Cover .......................................................................................op Cover ....................................................................................... ...................................................................................................................................... ..... 7-3..... 7-3  
7.3.4 Removing the M502 USB Interface PCBA 7.3.4 Removing the M502 USB Interface PCBA ...................................................................................................................... .................................................................................................................................. .... 7-4.... 7-4  
7.3.5 Removing the Speaker ................................................................................................................................................................... 7-47.3.5 Removing the Speaker ................................................................................................................................................................... 7-4  
7.3.6 Removing the AC-DC Module 7.3.6 Removing the AC-DC Module ...................................................................................................................... .................................................................................................................................. .......................... 7-5.......................... 7-5  
7.3.7 Removing the Power Managem7.3.7 Removing the Power Management and Interface Board PCBA ..................................................................................ent and Interface Board PCBA .................................................................................. .... 7-5.... 7-5  
7.3.8 Removing the ECG Board .............................................................................................................................................................. 7-67.3.8 Removing the ECG Board .............................................................................................................................................................. 7-6  
7.3.9 Removing the Battery Interface Board PC7.3.9 Removing the Battery Interface Board PCBA ..........................................................................................................BA .......................................................................................................... ............... 7-6............... 7-6  
7.3.10 Removing the Main Board 7.3.10 Removing the Main Board ........................................................................................................ .................................................................................................................................... .................................... 7-7.................................... 7-7  
7.3.11 Upgrading to Have Wi-Fi Function and Repair the Wi-Fi Module 7.3.11 Upgrading to Have Wi-Fi Function and Repair the Wi-Fi Module .................................................................................................................................... ............... 7-8............... 7-8  
7.3.12 Removing the Therm7.3.12 Removing the Thermal Print Head ......................................................................................................al Print Head ...................................................................................................... .................................... 7-9.................................... 7-9  
7.3.13 Removing the Button Board ...................................................................................................................................................... 7-97.3.13 Removing the Button Board ...................................................................................................................................................... 7-9  
7.3.14 Replacing the 7.3.14 Replacing the PowePower Button and r Button and Function Buttons Function Buttons ...................................................................................................................... ............................................... 7-9............................................... 7-9  
7.3.15 Removing the LCD 7.3.15 Removing the LCD ...................................................................................................................... .............................................................................................................................. ............................................. 7-10............................................. 7-10  
7.3.16 Removing the Top Cover 7.3.16 Removing the Top Cover .............................................................................................................. .................................................................................................................................... .................................. 7-10.................................. 7-10  
8 8 Parts Parts .................................................................................................................................................................................................................................................................................................................................................................. ...... 8-18-1  
8.1 Introduction ..................................................................................................................................................................................................... 8-18.1 Introduction ..................................................................................................................................................................................................... 8-1  
8.2 Main Unit ........................................................................................................................................................................................................... 8-28.2 Main Unit ........................................................................................................................................................................................................... 8-2  
8.2.1 Exploded View ................................................................................................................................................................................... 8-28.2.1 Exploded View ................................................................................................................................................................................... 8-2  
8.2.2 Parts List ............................................................................................................................................................................................... 8-28.2.2 Parts List ............................................................................................................................................................................................... 8-2  
8.3 Upper Housing Assembly 8.3 Upper Housing Assembly .................................................................................................................... ..................................................................................................................................................................................... 8-3............................................... 8-3  
8.3.1 Exploded View ................................................................................................................................................................................... 8-38.3.1 Exploded View ................................................................................................................................................................................... 8-3  
8.3.2 Parts List ............................................................................................................................................................................................... 8-38.3.2 Parts List ............................................................................................................................................................................................... 8-3  
8.4 Middle Frame Assembly8.4 Middle Frame Assembly ( (115-022702-00115-022702-00)) ......................................................................................................................................... 8-5 ......................................................................................................................................... 8-5  
8.4.1 Exploded View ................................................................................................................................................................................... 8-58.4.1 Exploded View ................................................................................................................................................................................... 8-5  
8.4.2 Parts List ............................................................................................................................................................................................... 8-58.4.2 Parts List ............................................................................................................................................................................................... 8-5  
8.5 Bottom Case Assembly8.5 Bottom Case Assembly ( (115-022703-00115-022703-00)) ........................................................................................................................................... 8-7 ........................................................................................................................................... 8-7  
8.5.1 Exploded View ................................................................................................................................................................................... 8-78.5.1 Exploded View ................................................................................................................................................................................... 8-7  
8.5.2 Parts List ............................................................................................................................................................................................... 8-78.5.2 Parts List ............................................................................................................................................................................................... 8-7  
  
  
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9 9 Replacement Parte, Replacement Parte, Software Software Upgrade Upgrade Package Package and and Accessories Accessories ................................................................................................................................................. ................. 9-19-1  
9.1 BeneHeart R12/R12A 9.1 BeneHeart R12/R12A BOM (V1.0) BOM (V1.0) for Repair, Upgradfor Repair, Upgrade and e and AccessorieAccessories ..................................................................................... s ..................................................................................... 9-19-1  
9.2 Parts Change List ................................................................................................................9.2 Parts Change List ................................................................................................................ .............................................................................................................................. .............. .............. 9-39-3  
A A Electrical Electrical Safety Safety Inspection Inspection ................................................................................................................................................................................................................................................................................ A-1.......... A-1  
A.1 Power Cord Plug A.1 Power Cord Plug ...................................................................................................................... .................................................................................................................................... ................................................................ A-1................................................................ A-1  
A.2 Device Enclosure and A.2 Device Enclosure and AccessorieAccessories s ............................................................................................................ ...................................................................................................................................... .................................. A-2.................................. A-2  
A.3 Device Labeling A.3 Device Labeling ...................................................................................................................................... ............................................................................................................................................ ..................................................... A-2..................................................... A-2  
A.4 Protective Earth Resistance A.4 Protective Earth Resistance .................................................................................................................................. ................................................................................................................................................ ............................... A-2............................... A-2  
A.5 Earth A.5 Earth Leakage TLeakage Test est .................................................................................................................................. ...................................................................................................................................... ..................................................... A-5..................................................... A-5  
A.6 Patient Leakage Current A.6 Patient Leakage Current .......................................................................................................................... .......................................................................................................................................... ............................................ A-6............................................ A-6  
A.7 Mains on Applied Part Leakage A.7 Mains on Applied Part Leakage ........................................................................................................................................ ................................................................................................................................................ .................... A-9.................... A-9  
A.8 Patient Auxiliary Current A.8 Patient Auxiliary Current .......................................................................................................... .................................................................................................................................. .....................................................A-11..................................................... A-11  
A.9 Scheduled Electrical A.9 Scheduled Electrical Safety Inspection Safety Inspection .......................................................................................................................... ................................................................................................................................................ ........... ........... A-12A-12  
A.10 Electrical Safety Inspection after Repair .....................................A.10 Electrical Safety Inspection after Repair ..................................... ............................................................................................................................................ ................................ ................................ A-13A-13  
  
  
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FOR YOUR NOTESFOR YOUR NOTES
  
  
1-11-1
11  GeneralGeneral
1.11.1  Revision HistoryRevision History
ManualManual
VersionVersion
Description Description of of Changes Changes Revision Revision Time Time SN SN SinceSince
1.0 1.0 First First release release December December 20132013
2.02.0
Add information on Wi-Fi Add information on Wi-Fi upgrade, repairing and troubleshootingupgrade, repairing and troubleshooting
Update Chapter 9 replacement parts, software upgrade package andUpdate Chapter 9 replacement parts, software upgrade package and
accessories listaccessories list
October 2014October 2014
  
  
1-21-2
1.21.2  Safety InformationSafety Information
WARNINGWARNING
   Indicates a potential hazard or unsafe practice that, Indicates a potential hazard or unsafe practice that, if not avoided, could result in death if not avoided, could result in death or serious injury.or serious injury.
CAUTIONCAUTION
   Indicates a potential hazard or unsafe practice that, Indicates a potential hazard or unsafe practice that, if not avoided, could result in minor personal injury if not avoided, could result in minor personal injury oror
product/property damage.product/property damage.
NOTENOTE
   Provides application tips or other useful information to ensure that you get Provides application tips or other useful information to ensure that you get the most from your product.the most from your product.
1.2.11.2.1  WarningsWarnings
WARNINGWARNING
   All installation operations, expansions, changes, modifications and repairs of this product are conducted byAll installation operations, expansions, changes, modifications and repairs of this product are conducted by
authorized personnel.authorized personnel.
   Disconnect the equipment from external power source and remove the Disconnect the equipment from external power source and remove the battery before disassembling thebattery before disassembling the
equipment.equipment.
   When you disassemble/reassemble the equipment, a patient leakage current When you disassemble/reassemble the equipment, a patient leakage current test must be performed beforetest must be performed before
it is put in use.it is put in use.
   The equipment must be connected to a properly installed The equipment must be connected to a properly installed power outlet with protective earth contacts only.power outlet with protective earth contacts only.
If the installation does not provide for a If the installation does not provide for a protective earth conductor, disconnect it from the power line protective earth conductor, disconnect it from the power line andand
operate it on battery power, if operate it on battery power, if possible.possible.
   Dispose of the package material, observing the applicable waste Dispose of the package material, observing the applicable waste control regulations and keeping it out ofcontrol regulations and keeping it out of
children’s reach.children’s reach.
  
  
1-31-3
1.2.21.2.2  CautionsCautions
CAUTIONCAUTION
   Make sure that no electromagnetic radiation interferes with Make sure that no electromagnetic radiation interferes with the performance of the equipment whenthe performance of the equipment when
preparing to carry out performance tests. Mobile phone, X-ray preparing to carry out performance tests. Mobile phone, X-ray equipment or MRI devices are a possibleequipment or MRI devices are a possible
source of interference as they source of interference as they may emit higher levels of electromagnetic radiation.may emit higher levels of electromagnetic radiation.
   Before connecting the equipment to the power line, Before connecting the equipment to the power line, check that the voltage and check that the voltage and frequency ratings of thefrequency ratings of the
power line are the same power line are the same as those indicated on the equipment’s label or as those indicated on the equipment’s label or in this manual.in this manual.
   Protect the equipment from damage caused by Protect the equipment from damage caused by drop, impact, strong vibration or other mechanical forcedrop, impact, strong vibration or other mechanical force
during servicing.during servicing.
1.2.31.2.3  NotesNotes
NOTENOTE
   Refer to Operation Manual for detailed operation and Refer to Operation Manual for detailed operation and other information.other information.
  
  
1-41-4
1.31.3  Equipment SymbolsEquipment Symbols
NOTENOTE
   Some symbols may not appear on your equipment.Some symbols may not appear on your equipment.
Equipotentiality Equipotentiality Analog Analog outout
Network Network connector connector USB USB connectorconnector
 Tele Telephone line conphone line connector nector ON/OFF fON/OFF for part of equipmor part of equipmentent
Battery Battery indicator indicator Alternating Alternating current current (AC)(AC)
Caution Caution Refer Refer to to instruction instruction manual/ manual/ bookletbooklet
DEFIBRILLATION-PROOF TYPE CFDEFIBRILLATION-PROOF TYPE CF
APPLIED PARTAPPLIED PART
Serial numberSerial number
Warning; ElectricityWarning; Electricity
ESD warning symbol ESD warning symbol for electrostaticfor electrostatic
sensitive devices.sensitive devices.
ManufaManufacturer cturer DATE DATE OF OF MANUAFACTUREMANUAFACTURE
Dispose of in accordance to yourDispose of in accordance to your
country’s requirementscountry’s requirements
Environment-friendly Used Period perEnvironment-friendly Used Period per
Chinese Standard SJ/T11363-2006Chinese Standard SJ/T11363-2006
China China Metrology Metrology Certification Certification Authorized Authorized represerepresentative ntative in in thethe
European CommunityEuropean Community
 The  The product product bears bears CE CE mark mark indicating indicating its its conformity conformity with with the the provisions provisions of of the the Council Council DirectiveDirective
93/42/EEC concerning medical devices and fulfils the essential requirements of Annex I of this93/42/EEC concerning medical devices and fulfils the essential requirements of Annex I of this
directive.directive.
  
  
2-12-1
22  Theory of OperationTheory of Operation
2.12.1  IntroductionIntroduction
BeneHeart R12/BeneHeart R12A electrocardiographs (hereafter referred to as “the equipment” or “the system”) areBeneHeart R12/BeneHeart R12A electrocardiographs (hereafter referred to as “the equipment” or “the system”) are
intended to acquire, analyze, display, store, and record electrocardiographic information for adult and children of anyintended to acquire, analyze, display, store, and record electrocardiographic information for adult and children of any
age from birth upwards for clinical age from birth upwards for clinical diagnosis and study.diagnosis and study.
 The equipme The equipment can be usent can be used to:d to:
   Acquire, analyze, displays, and record 12-lead Acquire, analyze, displays, and record 12-lead ECG information.ECG information.
   Provide ECG algorithm to automatically analyze the acquired ECG Provide ECG algorithm to automatically analyze the acquired ECG waveforms;output measuremewaveforms; output measurements andnts and
diagnosis.diagnosis.
   Support auto measurement, manual measurement, and Support auto measurement, manual measurement, and rhythm measurement.rhythm measurement.
   Print ECG reports through either an Print ECG reports through either an internal thermal recorder or an external printer.internal thermal recorder or an external printer.
   Store, preview, and review ECG reports.Store, preview, and review ECG reports.
   Connect LAN or Wi-Fi to send Connect LAN or Wi-Fi to send ECG data.ECG data.
   Support entering patient information through the keyboard or a Support entering patient information through the keyboard or a barcode reader.barcode reader.
   Present messages in case of Present messages in case of lead off, interference, low battery, or lead off, interference, low battery, or other abnormity.other abnormity.
 The following  The following picture showpicture shows the electrs the electrocardiogrocardiograph and the exteaph and the external devicesrnal devices..
   E   E
   t   t   h   h
  e  e
  r  r
  n  n
  e  e
   t   t
B   B   
u  u  
i   i   l   l   t  t  -  -  i   i   n  n  
  W   W   
i   i   -  -  F   F   
i   i   
  
  
2-22-2
2.22.2  Device ConnectorDevice Connector
All the connectors are located at the right side or at the rear, see the pictures below.All the connectors are located at the right side or at the rear, see the pictures below.
Right ViewRight View
1. 1. Patient Patient cable cable connector: connector: connects connects the the patient patient cable cable for for ECG ECG acquisition.acquisition.
2. 2. USB conUSB connector: conector: connects USnnects USB devices, B devices, such as such as a USB a USB drive, edrive, external pxternal printer, orinter, or barcodr barcode readee reader.r.
2.2.12.2.1  Back ViewBack View
1. 1. Battery Battery compartmecompartmentnt
2. 2. USB connUSB connector: coector: connects USnnects USB devices, B devices, such as such as a USB a USB drive, edrive, external pxternal printer, orinter, or barcodr barcode readee reader.r.
3. 3. Telephone Telephone line coline connector: nnector: for futfor future ure external external devices. devices. Do Do not unot use.se.
4. 4. Network Network connector: connector: a standard a standard RJ45 conneRJ45 connector for ctor for software software upgrade upgrade and sending and sending ECG data.ECG data.
5. 5. Analog Analog output output connector: connector: for for future future external external devices. devices. Do Do not unot use.se.
6. 6. Equipotential Equipotential Grounding Grounding Terminal: Terminal: when using when using the mothe monitor tognitor together wether with other ith other devices, codevices, connect theinnect theirr
equipotential grounding terminals together to eliminate the equipotential grounding terminals together to eliminate the potential differences between them.potential differences between them.
7. 7. AC poweAC power input: r input: connects tconnects the powehe power cord r cord to run to run the eqthe equipment ouipment on AC n AC power suppower supply.ply.
1 1 22 33 44 55 66 77
11 22
  
  
2-32-3
2.32.3  Main UnitMain Unit
 The electro The electrocardiograph ccardiograph consists of the fonsists of the following asseollowing assemblies:mblies:
    Top cover asse Top cover assembly: consists of mbly: consists of major buttomajor button board, display, ton board, display, touchpad board (ouchpad board (only for the enly for the equipment notquipment not
configuring a touchscreen), and keyboard kit.configuring a touchscreen), and keyboard kit.
   Middle frame assembly : consists of main Middle frame assembly : consists of main board (including the mother board and the daught board), thermalboard (including the mother board and the daught board), thermal
module, USB adapting board, speaker, power management board, ECG module, USB adapting board, speaker, power management board, ECG board, battery interface board, andboard, battery interface board, and
AC-DC module.AC-DC module.
   Lower cover assembly : is the paper tray assembly.Lower cover assembly : is the paper tray assembly.
 The following  The following picture showpicture shows the archits the architecture of tecture of the main unit.he main unit.
  
  
2-42-4
2.3.12.3.1  Top Cover AssemblyTop Cover Assembly  
Main button boardMain button board
Consists of the Consists of the following circuits:following circuits:
   Button scanning circuitButton scanning circuit
   Display signal level switching circuit (LVDS level to TTL level)Display signal level switching circuit (LVDS level to TTL level)
   LCD backlight creation circuitLCD backlight creation circuit
    Touch button sig Touch button signal transmission cirnal transmission circuitcuit
    Touchscreen  Touchscreen drive circuitdrive circuit
   Power switch and power indicator circuitPower switch and power indicator circuit
Touch keyboardTouch keyboard
Drives touch button and backlight.Drives touch button and backlight.
2.3.22.3.2  Middle Frame AssemblyMiddle Frame Assembly
LCDLCD
 Touch keypad bo Touch keypad board, onlyard, only
for equipment notfor equipment not
configured with configured with touchscreetouchscreenn
Main button boardMain button board
Keyboard kitKeyboard kit
Main board, including the daughter boardMain board, including the daughter board
ECG boardECG board
Batter Batter compartmentcompartment
Battery interface boardBattery interface board
 Thermal modu Thermal modulele
AC-DC moduleAC-DC module
Power management and interface boardPower management and interface board
SpeakerSpeaker
USB interface boardUSB interface board
  
  
2-52-5
AC/DC moduleAC/DC module
Converts AC power into DC power.Converts AC power into DC power.
Power management and interface boardPower management and interface board
Consists of the Consists of the following circuits:following circuits:
   Voltage conversion circuit to output 24 V power for recorder module and 5 V Voltage conversion circuit to output 24 V power for recorder module and 5 V power for main boardpower for main board
   Power management module circuitPower management module circuit
   Battery charging circuitBattery charging circuit
   IO circuitIO circuit
ECG boardECG board
Acquires the patient’s ECG signal.Acquires the patient’s ECG signal.
Main boardMain board
Runs system software, drive thermal module, runs data Runs system software, drive thermal module, runs data storage and some parameter software, including the Glasgowstorage and some parameter software, including the Glasgow
algorithm and filter algorithm.algorithm and filter algorithm.
Battery interface boardBattery interface board
Adapts the battery connector and Adapts the battery connector and the battery management board.the battery management board.
USB interface boardUSB interface board
Drives USB connector.Drives USB connector.
  
  
2-62-6
FOR YOUR NOTESFOR YOUR NOTES
  
  
3-13-1
33  Unpacking and InstallationUnpacking and Installation
3.13.1  Unpacking the EquipmentUnpacking the Equipment
Open the package and take out the packing list. Check that all the articles included in the packing Open the package and take out the packing list. Check that all the articles included in the packing list are availablelist are available
and the quantity and the quantity and specification are correct.and specification are correct.
   All the optional parts purchased by the All the optional parts purchased by the customer shall also be checked.customer shall also be checked.
   Notify the supplier if provided components are not correct as compared to the packing list.Notify the supplier if provided components are not correct as compared to the packing list.
   In case of damage during transportation, keep the packing material and notify the In case of damage during transportation, keep the packing material and notify the supplier immediatelysupplierimmediately..
   Keep the packing material till the equipment is accepted.Keep the packing material till the equipment is accepted.
3.23.2  Preparation for InstallationPreparation for Installation
1. 1. Ensure Ensure that the that the site msite meets eets all safety, all safety, environmental environmental and poand power rwer requiremenequirementsts
2. 2. Check Check that that required required power power sockets sockets are are available.available.
3. 3. Check that Check that a network a network connector connector is available if is available if the equipmthe equipment needs ent needs to be cto be connected to onnected to the wired the wired network.network.
3.2.13.2.1  Environmental RequirementsEnvironmental Requirements
 To  To avoid explosioavoid explosion hazard, do n hazard, do not use the enot use the equipment in quipment in the presencthe presence of flammable e of flammable anaesthetics, vapoanaesthetics, vapours or liquids.urs or liquids.
 The envir The environment wheronment where the equipme the equipment will be useent will be used should be rd should be reasonably free easonably free from vibrafrom vibration, dust and cotion, dust and corrosiverrosive
substances. If these conditions are not met, the accuracy of the system may be affected and damage may occur.substances. If these conditions are not met, the accuracy of the system may be affected and damage may occur.
EnvironmentEnvironment
Check and make Check and make sure that there is no sure that there is no electromagelectromagnetic interference source around the equipmentnetic interference source around the equipment, especially large, especially large
medical electrical equipment such medical electrical equipment such as radiological equipment and as radiological equipment and magnetic resonance imaging equipment etc. Switchmagnetic resonance imaging equipment etc. Switch
off these devices when necessaoff these devices when necessary. ry. Keep the examination rooKeep the examination room warm (no less than 18°C) to avoid muscle actionm warm (no less than 18°C) to avoid muscle action
voltages in ECG signal caused by cold.voltages in ECG signal caused by cold.
  
  
3-23-2
Power supplyPower supply
Check that power supply specification is met and the power cord is securely connected if mains power is used. UseCheck that power supply specification is met and the power cord is securely connected if mains power is used. Use
only power socket that is properly grounded.only power socket that is properly grounded.
 The powe The power supply specificar supply specifications are as ftions are as follows:ollows:
AC mainsAC mains
Input voltageInput voltage 100-240V100-240V～～   ((±±10%)10%)
Input powerInput power 100 VA100 VA
FrequencyFrequency 50 Hz/60 Hz (50 Hz/60 Hz (±±3 Hz)3 Hz)
BatteryBattery
Battery TypeBattery Type Rechargeable lithium-ion batteryRechargeable lithium-ion battery, 4500 , 4500 mAh, 11.1 VmAh, 11.1 V
Run timeRun time
For equipment in standard configure and with default setting, when powered by a newFor equipment in standard configure and with default setting, when powered by a new
fully-charged battery and at fully-charged battery and at ambient temperatambient temperature 25 ºC±5 ure 25 ºC±5 ºC:ºC:
≥400 auto reports, or no less ≥400 auto reports, or no less than one hour of continuous paper recording, or no less than 3.5than one hour of continuous paper recording, or no less than 3.5
hours of hours of paperless recordingpaperless recording
Charge timeCharge time
With the equipment power off:With the equipment power off:
≤6 h to 90% capacity≤6 h to 90% capacity
≤7 h to 100% capacity≤7 h to 100% capacity
Shutdown delayShutdown delay at least 5 minutes (after a at least 5 minutes (after a low battery message first occurs)low battery message first occurs)
3.2.23.2.2  Checking Paper Tray SizeChecking Paper Tray Size
 The equipme The equipment can print eitnt can print either on A4 (295 mher on A4 (295 mm × 210 mmm × 210 mm) or US L) or US Letter (8.5” etter (8.5” × 11”) paper× 11”) paper. Before . Before installing theinstalling the
equipment, check if the paper tray size is ok.equipment, check if the paper tray size is ok.
 To  To change the pchange the paper size, maper size, move the wove the white plastic spacehite plastic spacer bar in the paper bar in the paper tray to r tray to limit the papelimit the paper trayr tray..
   For A4 sized paper, insert the spacer in For A4 sized paper, insert the spacer in the slot at the the slot at the top of the paper tray.top of the paper tray.
   For US Letter sized paper, insert the spacer in the slot For US Letter sized paper, insert the spacer in the slot at the bottom of the at the bottom of the paper tray.paper tray.
Check that the paper tray is configured to meet the appropriate paper size for the destination location.Check that the paper tray is configured to meet the appropriate paper size for the destination location.
3.33.3  Turning On the EquipmentTurning On the Equipment
Once the equipment has been installed and checked, you can get ready for measurement and recording:Once the equipment has been installed and checked, you can get ready for measurement and recording:
1. 1. Connect the Connect the equipment equipment with AC mwith AC mains. If yoains. If you run the u run the equipment equipment on battery on battery power, epower, ensure that tnsure that the battery he battery isis
sufficiently charged.sufficiently charged.
2. 2. Press Press the the Power Power switch.switch.
  
  
4-14-1
44  Hardware and Software UpgradeHardware and Software Upgrade
4.14.1  Hardware UpgradeHardware Upgrade
4.1.14.1.1  Upgrading the Equipment to have Wi-Fi FunctionUpgrading the Equipment to have Wi-Fi Function
For the equipment not configured with the Wi-Fi function, there is no Wi-Fi module socket on the main board. ToFor the equipment not configured with the Wi-Fi function, there is no Wi-Fi module socket on the main board. To
upgrade the equipment, use a main upgrade the equipment, use a main board with Wi-Fi module socket to replace the original main board with Wi-Fi module socket to replace the original main board.board.
 The Glasgow  The Glasgow 12-lead resting 12-lead resting ECG algorithm ECG algorithm and the PDF and the PDF software pacsoftware package are includekage are included in the d in the Wi-Fi upgWi-Fi upgrade packagerade package..
 The Wi-F The Wi-Fi upgrade i upgrade package (PN: 115-022979-00) package (PN: 115-022979-00) consists of the consists of the following itefollowing items:ms:
   Main board PCBA, with Wi-Fi module socketMain board PCBA, with Wi-Fi module socket
   Wi-Fi module kitWi-Fi module kit
   System software packageSystem software package
   Glasgow 12-lead resting ECG algorithmGlasgow 12-lead resting ECG algorithm
   PDF software packagePDF software package
Refer toRefer to 7.3.11 Upgrading to Have Wi-Fi Function and Repair the Wi-Fi Module7.3.11 Upgrading to Have Wi-Fi Function and Repair the Wi-Fi Modulefor the upgrade procedure.for the upgrade procedure.
4.24.2  Software UpgradeSoftware Upgrade
You can upgrade the system by installing and running theYou can upgrade the system by installing and running the Mindray Patient Monitor Software Upgrade Tool (PN:Mindray Patient Monitor Software Upgrade Tool (PN:
110-000493-00)110-000493-00) on  on a PC a PC with Windows operating systemwith Windows operating system..
Connect the equipment to be upgraded and the PC running the upgrade tool to the same network, or directlyConnect the equipment to be upgraded and the PC running the upgrade tool to the same network, or directly
connect the equipment and the PC via a crossover network cable. Then configure the IP address of the PC. You canconnect the equipment and the PC via a crossover network cable. Then configure the IP address of the PC. You can
upgrade the following software:upgrade the following software:
No.No. Software typeSoftware type PN PN Description DescriptionRemarkRemark
11
System related softwareSystem related software
110-002925-00 110-002925-00 System System softwaresoftware
 / /
2 2 110-002926-00 110-002926-00 Language Language librarylibrary
3 3 110-002927-00 110-002927-00 Icon Icon librarylibrary
4 4 FPGA FPGA logic logic 110-002805-00110-002805-00
Main board chip writingMain board chip writing
softwaresoftware
5 5 LINUX LINUX platform platform software software 110-002924-00110-002924-00
Linux kernel, including theLinux kernel, including the
drivedrive
6 6 PDF PDF grid grid software software 110-002929-00 110-002929-00 PDF PDF grid grid softwaresoftware
7 7 EEPROM EEPROM mirror mirror file file 110-002928-00110-002928-00 EEPROM EEPROM configuratconfigurationion
  
  
4-24-2
No.No. Software typeSoftware type PN PN Description Description RemarkRemark
softwaresoftware
88
Glasgow ECG configurationGlasgow ECG configuration
filefile
110-002930-00110-002930-00
Glasgow 12-lead resting ECGGlasgow 12-lead resting ECG
algorithmalgorithm
Download as per theDownload as per the
purchase orderpurchase order
9 9 PDF PDF configuratioconfiguration n file file 110-002940-00 110-002940-00 PDF PDF configuratconfiguration ion packagepackage
Download as per theDownload as per the
purchase orderpurchase order
NOTENOTE
   No specific sequence is required when upgrading above software. For detailed information, please refNo specific sequence is required when upgrading above software. For detailed information, please refer toer to
4.2.2 Software Upgrade Procedure.4.2.2 Software Upgrade Procedure.
4.2.14.2.1  Installing Software Upgrade ToolInstalling Software Upgrade Tool
1. 1. Find Find the the installation installation programprogram ，，   and double and double click it to click it to start installation.start installation.
2. 2. Select Select language.3. language.3. Click Click [[Ok Ok ] and the following screen is displayed. Click [] and the following screen is displayed. Click [NextNext] to go to the next step.] to go to the next step.
4. 4. Enter Enter User User Name, Name, Company Company name, name, and the and the Serial Serial Number Number 26582640. Then 26582640. Then click [click [NextNext].].
  
  
4-34-3
5. 5. Specify Specify the dethe destination fstination folder older for installing for installing this progthis program. ram. Then seleThen select [ct [NextNext].].
6. 6. Select Select Program Program Folder. Folder. Then Then select select [[NextNext].].
7. 7. Click Click [[FinishFinish] to ] to complete installation.complete installation.
  
  
4-44-4
4.2.24.2.2  Software Upgrade ProcedureSoftware Upgrade Procedure
Before software upgrade, check the current software version. The software version is recorded on the bottom of theBefore software upgrade, check the current software version. The software version is recorded on the bottom of the
printed report. You can also check software version by entering factory maintenance. Refer toprinted report. You can also check software version by entering factory maintenance. Refer to 5.6 Factory 5.6 Factory
MaintenanceMaintenance..
 To upgrade  To upgrade the software:the software:
1. 1. Connect the Connect the equipment equipment to be upgto be upgraded and raded and the PC the PC running trunning the upgrade he upgrade tool to tool to the same the same network, or network, or directlydirectly
connect the equipment and the PC via a connect the equipment and the PC via a crossover network cable.crossover network cable.
2. 2. On the On the electrocardelectrocardiograph, piograph, press the ress the [Setup] [Setup] key to key to enter enter the maithe main menu. n menu. Select [Select [MaintenanceMaintenance]]→→[[NetworkNetwork
TypeType]. Set []. Set [Network TypeNetwork Type] to [] to [LANLAN].].
3. 3. Set tSet the IP he IP address address of the of the PC to PC to "77.77.1.XX" and "77.77.1.XX" and subnet msubnet mask to ask to "255.255.255.0"."255.255.255.0".
4. 4. Run Mindray Run Mindray Patient MoPatient Monitor Softnitor Software Uware Upgrade pgrade Tool on Tool on the PC the PC and set and set Machine to Machine to [[BeneHeart R12/R12ABeneHeart R12/R12A].].
5. 5. On the On the Mindray Mindray Patient Patient Monitor Monitor Software Software Upgrade Upgrade Tool scrTool screen, seeen, select [lect [Select PackageSelect Package] and then the ] and then the packagespackages
you want to upgrade. Then select [you want to upgrade. Then select [StartStart].].
6. 6. Turn on the eTurn on the equipment to quipment to be upgradedbe upgraded. Press and hold . Press and hold the "Ctrl" key the "Ctrl" key and the "B" key and the "B" key for 2 to 3 secfor 2 to 3 seconds. Then theonds. Then the
equipment enters the upgrade mode and starts equipment enters the upgrade mode and starts software upgrade automatically.software upgrade automatically.
 The upgrade  The upgrade progress is progress is displayed on both displayed on both the electrothe electrocardiograph ancardiograph and the PC. Softwd the PC. Software upgradeare upgraded finishes whend finishes when
the Upgrade Tool screen displays the Upgrade Tool screen displays “System upgraded successfully”.“System upgraded successfully”.
7. 7. Restart the Restart the equipment equipment and check tand check the currenhe current software t software version to version to verify if verify if the softwthe software is corare is correctly upgrectly upgraded.raded.
CAUTIONCAUTION
   Disconnect the equipment from the patient and Disconnect the equipment from the patient and make sure the important data are make sure the important data are saved beforesaved before
upgrade.upgrade.
   Do not shut down or power off the Do not shut down or power off the equipment when upgrading the system equipment when upgrading the system software. Otherwise, itsoftware. Otherwise, it
may cause the equipment to break may cause the equipment to break down.down.
   Software upgrade should be performed by qualified service personnel only.Software upgrade should be performed by qualified service personnel only.
   Crossover network cable is recommended when a PC is Crossover network cable is recommended when a PC is connected for software upgrade.connected for software upgrade.
NOTENOTE
   Make sure the version of the Make sure the version of the upgrade package is what you desired. To upgrade package is what you desired. To obtain the latest upgradeobtain the latest upgrade
package, please contact Mindray Customer Service Department.package, please contact Mindray Customer Service Department.
  
  
5-15-1
55  Testing and MaintenanceTesting and Maintenance
5.15.1  IntroductionIntroduction
 To  To ensure the ensure the equipment equipment always functionalways functions normally, s normally, refer rrefer regular inspectioegular inspection, maintenancen, maintenance, and test to q, and test to qualifiedualified
service personnel. This chapter provides a checklist service personnel. This chapter provides a checklist of the testing procedures with recommended testing tools andof the testing procedures with recommended testing tools and
frequencyfrequency. The service personnel should . The service personnel should perform the testing and perform the testing and maintenance procedmaintenance procedures as required and useures as required and use
appropriate testing tools.appropriate testing tools.
 The testing p The testing procedurrocedures providees provided in this chapter d in this chapter are inteare intended to vended to verify that the rify that the equipment equipment meets the pemeets the performancerformance
specifications. If the equipment or a module fails to perspecifications. If the equipment or a module fails to perform as specified in any test, repair or replace the equipmentform as specified in any test, repair or replace the equipment
or module to correct the or module to correct the problem. If you have any problem. If you have any question, contact our Customer Service Department.question, contactour Customer Service Department.
CAUTIONCAUTION
   All tests should be performed by qualified service personnel only.All tests should be performed by qualified service personnel only.
   Service personnel should acquaint themselves with the test tools and make Service personnel should acquaint themselves with the test tools and make sure that test toolssure that test tools
and cables are applicable.and cables are applicable.
5.1.15.1.1  Testing ToolTesting Tool
See the following sections.See the following sections.
5.1.25.1.2  Test ReportTest Report
Upon the completion of the Upon the completion of the tests, the table of tests, the table of preventatpreventative maintenance test reports and ive maintenance test reports and the table of the table of maintenancemaintenance
test reports in this chapter should be test reports in this chapter should be kept properlykept properly..
5.1.35.1.3  Preventative MaintenancePreventative Maintenance
Below are preventative maintenancBelow are preventative maintenance tests which e tests which need to be need to be performed on the equipment. See the performed on the equipment. See the following sectionsfollowing sections
for detailed maintenance procedures.for detailed maintenance procedures.
  
  
5-25-2
5.1.45.1.4  Recommended FrequencyRecommended Frequency
Check/Maintenance Check/Maintenance Item Item FrequencyFrequency
Visual inspectionVisual inspection 1. When first installed 1. When first installed or reinstalled.or reinstalled.
Power-on testPower-on test
1. When first installed 1. When first installed or reinstalled.or reinstalled.
2. Following any repairs or replacem2. Following any repairs or replacement of any main unit ent of any main unit parts.parts.
ECG testECG test
Performance TestPerformance Test 1. If the 1. If the user suspects that the measurement is incorrect.user suspects that the measurement is incorrect.
2. Following any repairs or replacement of relevant module.2. Following any repairs or replacement of relevant module.
3. At least once per year.3. At least once per year.Module CalibrationModule Calibration
Electric safetyElectric safety
teststests
Refer toRefer to A Electrical A Electrical
Safety InspectionSafety Inspection  
1. Following any repair or replacement1. Following any repair or replacement
2. After the equipment drops.2. After the equipment drops.
3. At least once every two years.3. At least once every two years.
Recorder checkRecorder check Following any repair or replacement of the recorder.Following any repair or replacement of the recorder.
Battery checkBattery check
Functional testFunctional test
1. When first installed.1. When first installed.
2. Whenever the battery is 2. Whenever the battery is replacedreplaced..
Performance Performance test test Once Once per per year, year, or or if if the the battery battery run run time time reduced reduced significsignificantly.antly.
5.25.2  Visual InspectionVisual Inspection
Inspect the equipment for obvious signs of damage. The test is passed if the Inspect the equipment for obvious signs of damage. The test is passed if the equipment has no obvious signs ofequipment has no obvious signs of
damage. Follow these guidelines when inspecting damage. Follow these guidelines when inspecting the equipment:the equipment:
   Carefully inspect the case, display screen, and keys for obvious Carefully inspect the case, display screen, and keys for obvious signs of damage.signs of damage.
   Inspect the power cord, wall mount, and accessories for obvious signs of Inspect the power cord, wall mount, and accessories for obvious signs of damage.damage.
   Inspect all external connections for loose connectors, bent pins or frayed cables.Inspect all external connections for loose connectors, bent pins or frayed cables.
   Inspect all connectors on the equipment for loose connectors or bent pins.Inspect all connectors on the equipment for loose connectors or bent pins.
   Make sure that safety labels and Make sure that safety labels and data plates on the equipment are clearly legible.data plates on the equipment are clearly legible.
5.35.3  Power-on TestPower-on Test
 This test is to  This test is to verify that tverify that the equipmehe equipment can powent can power up corrr up correctly. ectly. The test is passeThe test is passed if the equipd if the equipment starts up byment starts up by
following this following this procedurprocedure:e:
1. 1. Install the Install the battery, and battery, and connect the connect the equipment equipment to AC poto AC power. The wer. The AC mains indAC mains indicator and icator and battery indbattery indicator areicator are
illuminated.illuminated.
2. 2. Press Press the the Power Power switch switch to to turn turn on on the the equipment.equipment.
 The equipme The equipment performs self-tnt performs self-test when the est when the equipment equipment is powereis powered on. Corrd on. Corresponding meesponding message pops up if anssage pops up if anyy
problem is detected during problem is detected during power-on.power-on.
  
  
5-35-3
5.45.4  ECG Performance TestECG Performance Test
 Too Tool requirel required:d:
   Patient simulator, Medsim300B or Patient simulator, Medsim300B or equivalent equipmentequivalent equipment
 Te Test Method:st Method:
1. 1. Connect tConnect the patient che patient cable to thable to the equipme equipment under ent under test and thtest and the lead we lead wires to tires to the patient he patient simulator.simulator.
2. 2. Set the Set the patient simupatient simulator as folllator as follows: ECG ows: ECG sinus rhythm, sinus rhythm, HR = 80 HR = 80 bpm, with bpm, with the amplitudthe amplitude as 1 me as 1 mV (defauV (defaultlt
setting).setting).
3. 3. Check thCheck that the at the displayed Edisplayed ECG waveCG waveforms arforms are clear e clear and compleand complete withote without obvious ut obvious noise.noise.
4. 4. Press the Press the ECG key ECG key to start auto start automatic ECtomatic ECG measureG measurement. Priment. Print out the nt out the waveforms waveforms and diagnosis.and diagnosis.
5. 5. Check that Check that the displayed the displayed ECG waveECG waveforms are forms are clear and clear and complete complete with the with the amplitude of amplitude of lead II lead II waveform waveform about 10about 10
mm (assumed the Gain is set to mm (assumed the Gain is set to 10mm/mV), and diagnosis indicating sinus rhythm and HR 80 10mm/mV), and diagnosis indicating sinus rhythm and HR 80 bpm.bpm.
6. 6. Disconnect Disconnect each of theach of the leads in e leads in turn and turn and observe the observe the corresponding corresponding lead off mlead off message displayessage displayed on thed on the screen.e screen.
5.55.5  Battery CheckBattery Check
 Too Tool requirel required:d:
   NoneNone
Functional TestFunctional Test
1. 1. If the If the equipment equipment is installeis installed with d with a battea battery, rery, remove move the battthe battery ery first.first.
2. 2. Verify Verify that the that the equipment equipment works coworks correctly wrrectly when running hen running powered powered form the form the AC mains.AC mains.
3. 3. Remove Remove the the AC AC power power cord cord and and install install the the battery.battery.
4. 4. Turn oTurn on the n the equipment equipment and verand verify thaify that the t the equipment equipment still worstill works corrks correctly.ectly.
Performance TestPerformance Test
 To  To check the pecheck the performance of a rformance of a battery:battery:
1. 1. Disconnect Disconnect the the equipment equipment from from the the patient.patient.
2. 2. Connect thConnect the equipmee equipment to the nt to the AC mains. AC mains. Allow the batAllow the battery to tery to be chargbe charged unintered uninterrupted till rupted till the battery the battery is full andis full and
the battery indicator is off.the battery indicator is off.
3. 3. Disconnect Disconnect theAC mthe AC mains and allow ains and allow the equipmthe equipment to ent to run from run from the battery the battery until it shuuntil it shuts off.ts off.
4. 4. Verify Verify battery battery operating operating time time meets meets the the product product specification.specification.
  
  
5-45-4
5.65.6  Factory MaintenanceFactory Maintenance
 The equipme The equipment provides nt provides the Fthe Factory Maintenance mactory Maintenance mode for yode for you to check tou to check the equipmehe equipment convennt conveniently. iently. To To enter theenter the
Factory Maintenance mode:Factory Maintenance mode:
1. 1. Press Press the Sthe Setup keetup key on y on the fthe front panront panel to el to enter enter the mthe main menain menu.u.
2. 2. Select Select [[MaintenanceMaintenance] and enter the password.] and enter the password.
3. 3. Select Select [[Factory MaintenanceFactory Maintenance] and enter the password.] and enter the password.
 Then the eq Then the equipment automuipment automatically restartatically restarts to enter s to enter the Factory the Factory Maintenance moMaintenance mode.de.
In the In the FactoFactory Maintenance mode, you can ry Maintenance mode, you can perform the following tests:perform the following tests:
   Display testDisplay test
   Sound testSound test
   Keypad testKeypad test
   Lead wire checkLead wire check
   Recorder testRecorder test
   Internal communication testInternal communication test
   USB testUSB test
   Internal storage testInternal storage test
   Barcode reader testBarcode reader test
 To  To perform a testperform a test, select the de, select the desired item sired item and follow and follow the on-screethe on-screen prompt.n prompt.
In the Factory Maintenance mode, you can alsoIn the Factory Maintenance mode, you can also
   View device informationView device information
   Configure the equipmentConfigure the equipment
   Check work logCheck work log
  
Format the internal memoryFormat the internal memory
   Input the equipment's serial numberInput the equipment's serial number
   Debug the equipmentDebug the equipment
 To  To exit the maexit the maintenance mointenance mode, turn off the de, turn off the equipmentequipment..
5.75.7  Electrical Safety TestsElectrical Safety Tests
Refer toRefer to A Electrical Safety Inspection A Electrical Safety Inspection..
  
  
5-55-5
Maintenance and Test ReportMaintenance and Test Report
(See the above sections for (See the above sections for detailed test procedures and contents)detailed test procedures and contents)
Customer nameCustomer name
Customer addressCustomer address
Servicing personServicing person
Servicing companyServicing company
Equipment under test (EUT)Equipment under test (EUT)
Model of EUTModel of EUT
SN of EUTSN of EUT
Hardware versionHardware version
Software versionSoftware version
Test Test equipment equipment Model/No. Model/No. Expiration Expiration Date Date for for CalibrationCalibration
Test Test Contents Contents Test Test RecordRecord
Test ResultTest Result
(Pass/Fail)(Pass/Fail)
Visual InspectionVisual Inspection
 The housing,  The housing, display screedisplay screen, keys, pown, keys, power corder cord, and accessorie, and accessories have nos have no
obvious signs of obvious signs of damage.damage.
 The external c The external connecting cables aronnecting cables are not fraye not frayed and the ced and the connector pins aronnector pins are note not
loose and bent.loose and bent.
 The external c The external connectors are onnectors are not loose or not loose or their pins are their pins are not bent.not bent.
 The safety labe The safety labels and data platls and data plate are cleae are clearly legible.rly legible.
Power-on TestPower-on Test
 The power The power-on self test is passe-on self test is passed. The pod. The power indicawer indicator works ctor works correctly and orrectly and thethe
equipment starts up equipment starts up properlyproperly..
Performance testPerformance test
  
  
5-65-6
ECG performance test and calibrationECG performance test and calibration
 The ECG w The ECG waveformaveforms displayed s displayed and printed ouand printed out should be clet should be clear and complear and completete
without obvious noise. The amplitude of lead II waveform is about 10 mmwithout obvious noise. The amplitude of lead II waveform is about 10 mm
and diagnosis indicate sinus rhythm and HR 80 and diagnosis indicate sinus rhythm and HR 80 bpm.bpm.
ECG Lead Off prompt behaves correctly.ECG Lead Off prompt behaves correctly.
Recorder checkRecorder check
 The reco The recorder can prinrder can print ECG wt ECG waves corraves correctly and the prinectly and the printout is cleartout is clear..
Simulate recorSimulate recorder problems, such as out of paper der problems, such as out of paper and paper jam, theand paper jam, the
message "Check Recorder" shall message "Check Recorder" shall be presented.be presented.
Battery CheckBattery Check
 The equipme The equipment can operant can operates corretes correctly from bactly from battery powettery power when an ACr when an AC
power failure accidentally occurs.power failure accidentally occurs.
 The equipme The equipment can operant can operate independete independently on a single ntly on a single battery.battery.
Test conclusion:Test conclusion:
Tested Tested by: by: Test Test date:date:
  
  
6-16-1
66  TroubleshootingTroubleshooting
6.16.1  OverviewOverview
In this chapter, equipment problems are listed along with possible causes and recommended corrective actions. ReferIn this chapter, equipment problems are listed along with possible causes and recommended corrective actions. Refer
to the tables to check the to the tables to check the equipment, identify and eliminatequipment, identify and eliminate the troubles.e the troubles.
 The trouble The troubles we list hers we list here are fre are frequently aequently arisen difficulties and risen difficulties and the actions we the actions we recommrecommend can corrend can correct most prect most problems,oblems,
but not all but not all of them. For more information on troubleshooting, contact our Customer Service Department.of them. For more information on troubleshooting, contact our Customer Service Department.
6.26.2  Parts ReplacementParts Replacement
 The equipme The equipment's PCBs, mnt's PCBs, major parts and comajor parts and components are ponents are replaceablereplaceable. Once you . Once you isolate a PCB isolate a PCB you suspect deyou suspect defective,fective,
follow the instructions in follow the instructions in ChapterChapter 7 Disassembly and Repair t 7 Disassembly and Repair t o replace the PCB with a o replace the PCB with a known good one and checkknown good one and check
that the trouble disappears or the equipment passes all performance tests. Defective PCB can be sent to that the trouble disappears or the equipment passes all performance tests. Defective PCB can be sent to us for repair.us for repair.
If the If the trouble remains, exchangtrouble remains, exchange the replacement PCB with the e the replacement PCB with the original suspicious PCB and original suspicious PCB and continue troubleshootingcontinue troubleshooting
as directed in this as directed in this chapterchapter..
 To  To obtain informaobtain information on replaction on replacement parts or ement parts or order torder them, refhem, refer toer to 9 Replacement Parte, Software Upgrade9 Replacement Parte, Software Upgrade PackagePackage
and and AccessorieAccessories.s.
6.36.3  General Problems and PromptsGeneral Problems and Prompts
Refer toRefer to Chapter 9 TroubleshootingChapter 9 Troubleshooting of the equipment’s operating manual. of the equipment’s operating manual.
  
  
6-26-2
6.46.4  Troubleshooting GuideTroubleshooting Guide
6.4.16.4.1  Power On/Off FailurePower On/Off Failure
6.4.26.4.2  Recorder FailureRecorder FailureRecorder not work Recorder not work 
Printer unavailabledPrinter unavailabled
Replace printReplace print
head or mainhead or main
 board board
External printer isExternal printer is
selected. Change paperselected. Change paper
type to recorder.type to recorder.
 N N
 N N
Replace mainReplace main
 board board
YY
 N N
Replace main boardReplace main board
PromptPrompt
““Recorder doorRecorder door
not closednot closed””??
Prompt persists?Prompt persists?
YY
YY
  
YY
Check paperCheck paper
tray closed?tray closed?
 N N
Problem solved?Problem solved?
EndEnd
EndEndYY
Upgrade systemUpgrade system
software (includingsoftware (including
FPGA logic)FPGA logic)
PromptPrompt““RunRun
out of paper out of paper ””??
YY
Check paperCheck paper
 properly loaded properly loaded
Prompt persists?Prompt persists?
 N N
EndEnd
YY
Replace print headReplace print head
or main boardor main board
 N N
PromptPrompt““RecorderRecorder
unavailableunavailable””??
 N N
PromptPrompt““DeviceDevice
abnormal voltageabnormal voltage””??
 N N
YY
Replace powerReplace power
management boardmanagement board
  
  
  
6-36-3
6.4.36.4.3  Wrong System TimeWrong System Time
Wrong system time displayedWrong system time displayed
PromptPrompt
““RT clRT clockock Error Error ””??
YY OK OK 
Solved by resettingSolved by resetting
system timesystem time
 N N
 N N
 No cell button  No cell button oror
cell button failedcell button failed
 N N
Replace main boardReplace main board
YY
Replace mainReplace main
 board board
YY RReeppllaacce e bbuuttttoon n cceellll
  
  
6-46-4
6.4.46.4.4  Wi-Fi Related FailuresWi-Fi Related Failures
Symptoms Symptoms Possible Possible Cause Cause ActionAction
Wi-Fi function does not work. NoWi-Fi function does not work. No
Wi-Fi icon shows at the top of theWi-Fi icon shows at the top of the
screen.screen.
Wi-Fi Wi-Fi module module is is not not properly properly installinstalled. ed. ReinstaReinstall ll the the Wi-Fi Wi-Fi module module properly.properly.
Wi-Fi Wi-Fi module module fails fails Replace Replace the the Wi-Fi Wi-Fi module.module.
Main Main board board fails fails Replace Replace the the main main board.board.
 The equipme The equipment is frequennt is frequently off linetly off line
or disconnects from the network.or disconnects from the network.
 The Wi The Wi-Fi anten-Fi antenna is detached na is detached fromfrom
the equipment housing, or detachedthe equipment housing, or detached
from the Wi-Fi module, or thefrom the Wi-Fi module, or the
antenna is damaged.antenna is damaged.
1. Visually check if 1. Visually check if the Wi-Fi antenna isthe Wi-Fi antenna is
damaged. If yes, replace the antenna.damaged. If yes, replace the antenna.
2. If the 2. If the antenna is not damaged,antenna is not damaged,
check that the Wi-Fi antenna ischeck that the Wi-Fi antenna is
properly connected with the module.properly connected with the module.
Secure the antenna properly.Secure the antenna properly.
Wi-Fi Wi-Fi module module failure. failure. Replace Replace the the Wi-Fi Wi-Fi module.module.
Wi-Fi Wi-Fi signal signal is is unstable unstable Check Check that that the the hospital hospital Wi-Fi Wi-Fi signal signal isis
stable.stable.
Unable to connect the Unable to connect the network. Thenetwork. The
network disconnected symbolnetwork disconnected symbol
shows at the top of shows at the top of the screen.the screen.
Wrong network parameter settings,Wrong network parameter settings,
for example, IP address is notfor example, IP address is not
correctly set or the password is notcorrectly set or the password is not
correct.correct.
Check if there is IP conflict. Re-set theCheck if there is IP conflict. Re-set the
IP address correctly and enter correctIP address correctly and enter correct
password.password.
 The W The Wi-Fi signal is i-Fi signal is weak. weak. Check that hoCheck that hospital Wi-Fspital Wi-Fi signal isi signal is
stable and strong.stable and strong.
 The W The Wi-Fi anteni-Fi antenna is detached na is detached fromfrom
the equipment housing, or detachedthe equipment housing, or detached
from the Wi-Fi module.from the Wi-Fi module.
Secure the antenna properly.Secure the antenna properly.
Main Main board board fails fails Replace Replace the the main main board.board.
  
  
7-17-1
77  Disassembly and RepairDisassembly and Repair
7.17.1  Tools RequiredTools Required
 To  To disassemble and rdisassemble and replace the parts and eplace the parts and componencomponents, the followts, the following tools maing tools may be reqy be required:uired:
   Philips Philips screwdriverscrewdriverss
    Tweezers Tweezers
   Sharp nose pliersSharp nose pliers
   ClampClamp
7.27.2  Preparations for DisassemblyPreparations for Disassembly
Before disassembling the equipment, finish Before disassembling the equipment, finish the following preparations:the following preparations:
   Stop measuring, turn off the equipment, and disconnect all the accessories and peripheral devices.Stop measuring, turn off the equipment, and disconnect all the accessories and peripheral devices.
   Disconnect the AC power source Disconnect the AC power source and remove the battery.and remove the battery.
WARNINGWARNING
   All the operations should be performed by qualified service personnel only.All the operations should be performed by qualified service personnel only.
   Before disassembling the equipment, be sure to eliminate the Before disassembling the equipment, be sure to eliminate the static charges first. Whenstatic charges first. When
disassembling the parts labeled with static-sensitive symbols, make sure you are wearingdisassembling the parts labeled with static-sensitive symbols, make sure you are wearing
electrostatic discharge protection such as antistatic wristband or gloves to avoid damaging theelectrostatic discharge protection such as antistatic wristband or gloves to avoid damaging the
equipment.equipment.
   Follow correct sequence to disassembly the equipment. Otherwise, the equipment may beFollow correct sequence to disassembly the equipment. Otherwise, the equipment may be
damaged permanently.damaged permanently.
   Be sure to disconnect all the cables before Be sure to disconnect all the cables before disassembling any parts. Be sure not to damage disassembling any parts. Be sure not to damage anyany
cables or connectors.cables or connectors.
   Place the screws and parts from the Place the screws and parts from the same module together to facilitate reassembling.same module together to facilitate reassembling.
   Be sure to place removed screws and disassembled parts properly, preventing them Be sure to place removed screws and disassembled parts properly, preventing them from beingfrom being
lost or contaminated.lost or contaminated.
   To reassemble the equipment, first assemble the assemblies, and then To reassemble the equipment, first assemble the assemblies, and then the main unit. Carefullythe main unit. Carefully
route the cables.route the cables.
   Properly connect and route the cables and wires Properly connect and route the cables and wires when reassembling the equipment to avoidwhen reassembling the equipment to avoid
short circuit.short circuit.
   Select appropriate screws to assemble the equipment. If unfit Select appropriate screws to assemble the equipment. If unfit screws are tightened by force, thescrews are tightened by force, the
equipment may be damaged and the equipment may be damaged and the screws or part may fall off screws or part may fall off during use, causingduring use, causing
unpredictable equipment damage or human injury.unpredictable equipment damage or human injury.
  
  
7-27-2
7.37.3  Disassembling the Main UnitDisassembling the Main Unit
 To  To disassemble the disassemble the equipmentequipment, place the eq, place the equipment on a wuipment on a work bench frork bench free from fee from foreignmoreign material, avoaterial, avoiding damagingiding damaging
the screen.the screen.
7.3.17.3.1  Removing the BatteryRemoving the Battery
1. 1. Disconnect tDisconnect the AC mhe AC mains. Lay the ains. Lay the equipment equipment on the won the work bench. ork bench. Unscrew tUnscrew the M3×6 screhe M3×6 screw that sew that secures thecures the
battery door.battery door.
2. 2. Remove Remove the the battery.battery.
7.3.27.3.2  Removing Bottom Case AssemblyRemoving Bottom Case Assembly
1. 1. Pull Pull out out the the paper paper tray tray to tto the ehe extent xtent as showas shown ben below.low.
2. 2. Unscrew Unscrew the sethe seven M4X10 ven M4X10 screws screws and reand remove move the botthe bottom ctom case assemase assembly.bly.
  
  
7-37-3
 The bottom  The bottom case assembly case assembly consists of 5 rconsists of 5 replaceable parts:eplaceable parts:
115-022838-00 115-022838-00 Bottom Bottom case case FRUFRU
115-022839-00 115-022839-00 Recorder Recorder door door FRUFRU
043-003531-00 043-003531-00 Paper Paper tray tray top top covercover
043-003532-00 043-003532-00 Spacer Spacer barbar
115-022972-00 115-022972-00 Paper Paper tray tray FRU, FRU, with with label label instructing instructing paper paper loadingloading
7.3.37.3.3  Removing the Top CoverRemoving the Top Cover
1. 1. Unscrew Unscrew the the eight eight M4×10 scrM4×10 screwing ewing securing securing the the top top cover cover assembly.assembly.
2. 2. Disconnect Disconnect the cable the cable connecting connecting the mthe main board ain board and the and the button button board.board.
3. 3. Remove Remove the the top top cover.cover.
NoteNote
   You do not need to remove any screws securing the You do not need to remove any screws securing the main plate hold (FTP) when removing themain plate hold (FTP) when removing the
top cover.top cover.
  
  
7-47-4
7.3.47.3.4  Removing the M502 USB Interface PCBARemoving the M502 USB Interface PCBA
After removing the top cover assembly, unscrew the M3×6 screw. Then you can remove the M502 USB interface PCBA.After removing the top cover assembly, unscrew the M3×6 screw. Then you can remove the M502 USB interface PCBA.
7.3.57.3.5
  
Removing the SpeakerRemoving the SpeakerRelease the two clips, and then remove the speaker.Release the two clips, and then remove the speaker.
  
  
7-57-5
7.3.67.3.6  Removing the AC-DC ModuleRemoving the AC-DC Module
Unscrew the four M3×6 screws to remove the power supply board (16V, 63 W).Unscrew the four M3×6 screws to remove the power supply board (16V, 63 W).
7.3.77.3.7  Removing the Power Management and Interface Board PCBARemoving the Power Management and Interface Board PCBA
1. 1. Unscrew Unscrew the the five five M3×6 M3×6 screws.screws.
2. 2. Remove Remove the the power power management management and and interface interface board board PCBA.PCBA.
3. 3. Press doPress down the lown the lock on the ck on the socket and socket and carefully disccarefully disconnect the onnect the cable connectcable connecting the ming the main board aain board and the pond the powerwer
managememanagement nt board.board.
Lock on the socketLock on the socket
  
  
7-67-6
7.3.87.3.8  Removing the ECG BoardRemoving the ECG Board
1. 1. Unscrew Unscrew the the four four M3×6 M3×6 screws.screws.
2. 2. Remove Remove the the ECG ECG board board PCBA.PCBA.
7.3.97.3.9  Removing the Battery Interface Board PCBARemoving the Battery Interface Board PCBA
1. 1. Unscrew Unscrew the the two two M3 M3 nuts.nuts.
2. 2. Remove Remove the the battery battery interface interface board board PCBA.PCBA.
When reassemble the battery interface board PCBA:When reassemble the battery interface board PCBA:
1. 1. Place Place the the battery battery in in the the battery battery compartmencompartment.t.
2. 2. Check Check that the that the battery battery properly properly connects connects with the with the battery battery interface interface board.board.
3. 3. Tight Tight the the two two M3 M3 nuts.nuts.
4. 4. Take Take out out the the battery.battery.
NOTENOTE
   Do not allow metal parts to touch the Do not allow metal parts to touch the welding point during removing and reassemling thewelding point during removing and reassemling the
battery interface board.battery interface board.
  
  
7-77-7
7.3.107.3.10  Removing the Main BoardRemoving the Main Board
1. 1. Unscrew Unscrew the the five five M3×6 M3×6 screws.screws.
2. 2. Remove Remove the the main main board.board.
  
  
7-87-8
7.3.117.3.11  Upgrading to Have Wi-Fi Function and Repair the Wi-Fi ModuleUpgrading to Have Wi-Fi Function and Repair the Wi-Fi Module
Follow this procedure to upgrade the equipment to have the Wi-Fi function:Follow this procedure to upgrade the equipment to have the Wi-Fi function:
1. 1. Remove Remove the the main main control control board board as as instructed instructed byby 7.3.10 Removing the Main Board 7.3.10 Removing the Main Board  . .
2. 2. Install the Install the Wi-Fi module Wi-Fi module on the mon the main control ain control board FRU board FRU that has a that has a Wi-Fi module Wi-Fi module connector. connector. Connect the Connect the Wi-FiWi-Fi
antenna.antenna.
3. 3. Install the Install the main contrmain control board Fol board FRU on tRU on the electrhe electrocardiographyocardiography. Secure . Secure the main cthe main control board ontrol board FRU with FRU with fivefive
M3×6 screws.M3×6 screws.
4. 4. Stick the Stick the antenna as antenna as indicated indicated by the by the following pictfollowing picture. Secure. Secure the ure the antenna cable antenna cable with a with a tape.tape.
Wi-Fi moduleWi-Fi module
Wi-Fi antennaWi-Fi antenna
Stick the Wi-FiStick the Wi-Fi
antenna hereantenna here
Stick the Wi-FiStick the Wi-Fi
antenna hereantenna here
Secure the Wi-FiSecure the Wi-Fi
cable with a tapecable with a tape
  
  
7-97-9
 To  To repair the repair the Wi-Fi mWi-Fi module,odule,
1. 1. Remove Remove the the tape tape that that secures secures the the Wi-Fi Wi-Fi antenna.antenna.
2. 2. Remove Remove the the main main board board as as instructed instructed byby 7.3.10 Removing the Main Board 7.3.10 Removing the Main Board  . .
3. 3. Disconnect Disconnect the the Wi-Fi Wi-Fi antenna antenna cable cable from from the the Wi-Fi Wi-Fi module.module.
4. 4. Remove Remove the the Wi-Fi Wi-Fi module module and and replace replace with with a new a new one.one.
7.3.127.3.12  Removing the Thermal Print HeadRemoving the Thermal Print Head
1. 1. Unscrew Unscrew the the three three M3×6 M3×6 screws.screws.
2. 2. Remove Remove the the thermal thermal print print head.head.
7.3.137.3.13
  
Removing the Button BoardRemoving the Button Board
1. 1. Unscrew Unscrew the the seven seven PT3×8 PT3×8 tapping tapping screws.screws.
2. 2. Remove Remove the the button button board.board.
7.3.147.3.14  Replacing the Power Button and Function ButtonsReplacing the Power Button and Function Buttons
You can replace the power button and function buttons after removing the button board.You can replace the power button and function buttons after removing the button board.拆拆  
  
  
7-107-10
7.3.157.3.15  Removing the LCDRemoving the LCD
1. 1. Unscrew Unscrew the the four four PT3×8 PT3×8 tapping tapping screws.screws.
2. 2. Disconnect Disconnect the the wire wire connecting connecting the the button button board.board.
3. 3. Remove Remove the the LCD LCD holder.holder.
4. 4. Remove Remove the the LCD.LCD.
Remove the LCD.Remove the LCD.
7.3.167.3.16  Removing the Top CoverRemoving the Top Cover
 The top co The top cover does nover does not include the t include the LCD asseLCD assembly, bumbly, button boardtton board, and keyboar, and keyboard holderd holder..
 The top co The top cover FRU haver FRU has the followins the following configurg configurations:ations:
115-022830-00 115-022830-00 Top Top cover cover FRU FRU (R12 (R12 lens)lens)
115-02115-022831-02831-00 0 Top Top cover cover FRU FRU (R12(R12 touchscreen)touchscreen)
115-022832-00 115-022832-00 Top Top cover cover FRU FRU (R12A (R12A lens)lens)
115-02115-022833-02833-00 0 Top Top cover cover FRU FRU (R12A (R12A touchscreen)touchscreen)
 The top co The top cover FRU ver FRU for the eqfor the equipment couipment configured wnfigured with the toucith the touchscreen consists thscreen consists the following he following parts:parts:
    Top cover ( Top cover (R12 mark or R12A R12 mark or R12A mark)mark)
   KeyboardKeyboard
    Touchscreen  Touchscreen (R12 orR12A)(R12 orR12A)
 The top co The top cover FRU ver FRU for the eqfor the equipment not uipment not configured configured with the touwith the touchscreen cchscreen consists the folloonsists the following parts:wing parts:
    Top cover ( Top cover (R12 mark or R12A R12 mark or R12A mark)mark)
   KeyboardKeyboard
   Lens (R12 or R12A)Lens (R12 or R12A)
    Touch keypad  Touch keypad boardboard
Wire connectingWire connecting
the button boardthe button board
LCD holderLCD holder
LCD holderLCD holder
  
  
8-18-1
88  PartsParts
8.18.1  IntroductionIntroduction
 This chapter c This chapter contains the exontains the exploded views anploded views and parts lists of the d parts lists of the main unit. It helps main unit. It helps the engineethe engineer to identify r to identify the partsthe parts
during disassembling the equipment and replacing the parts. This during disassembling the equipment and replacing the parts. This manual is based manual is based on the maximum configuration.on the maximum configuration.
YoYour equipment may not have same parts and the ur equipment may not have same parts and the quantity of the screws or stacking sleeves etc. may be different withquantity of the screws or stacking sleeves etc. may be different with
those included in the parts lists.those included in the parts lists.
NOTENOTE
   The part number listed in the The part number listed in the Parts List is only for checking the Parts List is only for checking the FRU part number which is alsoFRU part number which is also
included in the Parts List. Please provide the included in the Parts List. Please provide the FRU parts number if you want FRU parts number if you want to purchase theto purchase the
spare parts.spare parts.
  
  
8-28-2
8.28.2  Main UnitMain Unit
8.2.18.2.1  Exploded ViewExploded View
8.2.28.2.2  Parts ListParts List
SN SN PN PN DescriptionDescription
1 1 / / Top Top cover cover assemblyassembly
2 2 / / Middle Middle panel panel assemblyassembly
3 3 / / Bottom Bottom case case assemblyassembly
4 4 / / Cross Cross pan pan head head screw, screw, GB/T818-2000 GB/T818-2000 M4×8M4×8
  
  
8-38-3
8.38.3  Upper Housing AssemblyUpper Housing Assembly
8.3.18.3.1  Exploded ViewExploded View
8.3.28.3.2  Parts ListParts List
PN PN Description Description FRU FRU part part number number RemarksRemarks
1 1 //
LensLens
115-023370-00115-023370-00
Lens and touch keypad board FRU,Lens and touch keypad board FRU,
for R12for R12
115-023371-00115-023371-00
Lens and touch keypad board FRU,Lens and touch keypad board FRU,
for R12Afor R12A
 Tou Touchscreenchscreen
021-000132-00 021-000132-00 For For R12R12
021-000140-00 021-000140-00 For For R12AR12A
  
  
8-48-4
PN PN Description Description FRU FRU part part number number RemarksRemarks
2 2 //
 To Touch keypad boaruch keypad board (onlyd (only
for the machine notfor the machine not
configureconfigured d withwith
touchscreen)touchscreen)
115-023370-00115-023370-00
Lens and touch keypad board FRU,Lens and touch keypad board FRU,
for R12for R12
115-023371-00115-023371-00
Lens and touch keypad board FRU,Lens and touch keypad board FRU,
for R12Afor R12A
3 3 / / Top Top covercover
115-022830-00115-022830-00
 To Top cover Fp cover FRU (R12 lens), uRU (R12 lens), usedsed
when keyboard or top cover needswhen keyboard or top cover needs
to be replaced.to be replaced.
115-022832-00115-022832-00
 Top  Top cover Fcover FRU (R12A lens), uRU (R12A lens), usedsed
when keyboard or top cover needswhen keyboard or top cover needs
to be replaced.to be replaced.
115-022831-00115-022831-00
 To Top cover Fp cover FRU (R12 touchRU (R12 touchscreen),screen),
used when keyboard or top coverused when keyboard or top cover
needs to be replaced.needs to be replaced.
115-022833-00115-022833-00
 To Top cover Fp cover FRU (R12A toucRU (R12A touchscreen),hscreen),
used when keyboard or top coverused when keyboard or top cover
needs to be replaced.needs to be replaced.
4 4 049-000600-00 049-000600-00 PowePower r key key 049-000600-00 049-000600-00 //
5 5 049-000601-00 049-000601-00 Main Main function function keys keys 049-000601-00 049-000601-00 //
6 6 / / LCD LCD dust-proof, dust-proof, long long / / //
7 7 / / LCD LCD dust-proof, dust-proof, short short / / //
8 8 021-000130-00 021-000130-00 LCDLCD, , 8-inch 8-inch 115-022834-00 115-022834-00 LCD LCD FRUFRU
9 9 049-000635-00 049-000635-00 LCD LCD limit limit block block 049-000635-00 049-000635-00 //
10 M04-003105---10 M04-003105---
Cross pan head tappingCross pan head tapping
screw, PT3×8screw, PT3×8
 /  / //
11 11 / / LCD LCD securing securing plate plate / / //
12 12 051-001505-00M502 051-001505-00M502 Major Major button button board board 051-001505-00M502 051-001505-00M502 //
13 13 / / KeyboardKeyboard
115-022830-00115-022830-00
 Top  Top cover Fcover FRU (R12 lens), useRU (R12 lens), usedd
when keyboard or top cover needswhen keyboard or top cover needs
to be replaced.to be replaced.
115-022832-00115-022832-00
 Top  Top cover Fcover FRU (R12A lens), uRU (R12A lens), usedsed
when keyboard or top cover needswhen keyboard or top cover needs
to be replaced.to be replaced.
115-022831-00115-022831-00
 To Top cover Fp cover FRU (R12 touchRU (R12 touchscreen),screen),
used when keyboard or top coverused when keyboard or top cover
needs to be replaced.needs to be replaced.
115-022833-00115-022833-00
 To Top cover Fp cover FRU (R12A toucRU (R12A touchscreen),hscreen),
used when keyboard or top coverused when keyboard or top cover
needs to be replaced.needs to be replaced.
14 14 042-009257-00 042-009257-00 Keyboard Keyboard holder holder / / //
15 15 / / Magnetic Magnetic ring ring holder holder / / //
16 /16 /
Magnetic ring, CORE,Magnetic ring, CORE,
28(24)*15*3.5(0.75) mm ,28(24)*15*3.5(0.75) mm ,
Flat ferriteFlat ferrite
 /  / //
  
  
8-58-5
8.48.4  Middle Frame AssemblyMiddle Frame Assembly   115-022702-00115-022702-00))
8.4.18.4.1  Exploded ViewExploded View
8.4.28.4.2  Parts ListParts List
PN PN Description Description FRU FRU part part number number RemarksRemarks
1 1 009-003818-00 009-003818-00 AC AC input input receptreceptacle acle cable cable 009-003818-00 009-003818-00 //
2 2 020-000015-00 020-000015-00 SpeakerSpeaker, , 2W, 2W, 4ohm, 4ohm, 60mm 60mm 020-000015-00 020-000015-00 //
3 3 043-003530-00 043-003530-00 Battery Battery door door 043-003530-00 043-003530-00 //
4 4 043-003525-00 043-003525-00 Middle Middle frame frame 043-003525-00 043-003525-00 //
  
  
8-68-6
PN PN Description Description FRU FRU part part number number RemarksRemarks
5 5 049-000591-00 049-000591-00 USB USB plug plug (white) (white) 049-000591-00 049-000591-00 //
6 6 M04-002505--- M04-002505--- Cross Cross pan pan head head screw screw / / //
7 7 022-000159-00 022-000159-00 AC-DC AC-DC module, module, 15V, 15V, 63W 63W 022-000159-00 022-000159-00 //
8 8 M04-051141--- M04-051141--- Cross Cross pan pan head head screw screw kit, kit, M4×8 M4×8 / / //
9 051-001502-009 051-001502-00
M502 power management andM502 power management and
interface board PCBA interface board PCBA (standard)(standard)
051-001502-00 /051-001502-00 /
10 10 / / Main Main board board PCBAPCBA
115-022978-00115-022978-00
Main board FRU, standardMain board FRU, standard
configurationconfiguration
115-022837-00115-022837-00
Main board FRU, fullMain board FRU, full
configurationconfiguration
115-022981-00115-022981-00Main board FRU, standardMain board FRU, standard
configuratioconfiguration, n, withwith
Glasgow algorithmGlasgow algorithm
115-022836-00115-022836-00
Main board FRU, fullMain board FRU, full
configuratioconfiguration, n, withwith
Glasgow algorithmGlasgow algorithm
115-022989-00115-022989-00
Main board FRU, standardMain board FRU, standard
configuratioconfiguration, with n, with PDFPDF
softwaresoftware
115-022988-00115-022988-00
Main board FRU, fullMain board FRU, full
configuratioconfiguration, with n, with PDFPDF
softwaresoftware
115-022980-00115-022980-00
Main board FRU, standardMain board FRU, standard
configuratioconfiguration, n, withwith
Glasgow algorithm andGlasgow algorithm and
PDF softwarePDF software
115-022835-00115-022835-00
Main board FRU, fullMain board FRU, full
configuratioconfiguration, n, withwith
Glasgow and PDFGlasgow and PDF
11 11 051-001339-00 051-001339-00 ECG ECG board board PCBA PCBA 051-001339-00 051-001339-00 //
12 12 M05-010002-06 M05-010002-06 Lithium Lithium battery, battery, 11.1V, 11.1V, 4500mAh 4500mAh M05-010002-06 M05-010002-06 //
13 13 / / Equipotential Equipotential grounding grounding terminal terminal / / //
14 14 / / Lock Lock washer washer / / //
15 15 051-001503-00 051-001503-00 M502 M502 USB USB interface interface board board PCBA PCBA 051-001503-00 051-001503-00 //
16 16 M04-051001-00 M04-051001-00 Cross Cross pan pan head head screwscrew, , M4×8 M4×8 / / //
17 17 051-001460-00 051-001460-00 Battery Battery interface interface board board PCBA PCBA / / //
18 18 / / Main Main plate plate holder holder / / //
19 19 M04-011002--- M04-011002--- Nut Nut & & lock lock washer washer kit, kit, M3 M3 / / //
20 20 024-000534-00 024-000534-00 Thermal Thermal print print head, head, 216mm 216mm 024-000534-00 024-000534-00 //
  
  
8-78-7
8.58.5  Bottom Case AssemblyBottom Case Assembly   115-022703-00115-022703-00))
8.5.18.5.1  Exploded ViewExploded View
8.5.28.5.2  Parts ListParts List
PN PN Description Description FRU FRU part part number number RemarksRemarks
1 1 043-003531-00 043-003531-00 Paper Paper tray tray top top covercover   043-003531-00 /043-003531-00 /
2 M04-003105---2 M04-003105--- Cross head topping screw,Cross head topping screw,PT3×8PT3×8    /  / //
3 3 043-003526-00 043-003526-00 Bottom Bottom case case 043-003526-00 043-003526-00 //
4 043-003532-004 043-003532-00 Spacer barSpacer bar   043-003532-00 /043-003532-00 /
5 5 115-022839-00 115-022839-00 Recorder Recorder door door FRUFRU   115-022839-00 /115-022839-00 /
  
  
99--44
  
FOR YOUR NOTESFOR YOUR NOTES
  
  
9-19-1
99  Replacement Parte, Software Upgrade Package andReplacement Parte, Software Upgrade Package and
AccessoriesAccessories
9.19.1  BeneHeart R12/R12A BOM (V1.0) for Repair, Upgrade and AccessoriesBeneHeart R12/R12A BOM (V1.0) for Repair, Upgrade and Accessories
SN SN Part Part Number Number Part Part DescriptionDescription
1.1.   115-022978-00 115-022978-00 Standard Standard Mainboard Mainboard FRUFRU
2.2.   115-022837-00 115-022837-00 Full Full Mainboard Mainboard FRUFRU
3.3.   115-022981-00 115-022981-00 Standard Standard Mainboard Mainboard FRU(GlasgoFRU(Glasgow)w)
4.4.   115-022836-00 115-022836-00 Full Full Mainboard Mainboard FRU(GlasgoFRU(Glasgow)w)
5.5.   115-022989-00 115-022989-00 Standard Standard Mainboard Mainboard FRU(PDF)FRU(PDF)
6.6.   115-022988-00 115-022988-00 Full Full Mainboard Mainboard FRU(PDF)FRU(PDF)
7.7.   115-022980-00 115-022980-00 Standard Standard Mainboard Mainboard FRU(GlasgoFRU(Glasgow/PDF)w/PDF)
8.8.   115-022835-00 115-022835-00 Full Full Mainboard Mainboard FRU(GlasgFRU(Glasgow/PDF)ow/PDF)
9.9.   022-000159-00 022-000159-00 POWER POWER SUPPLSUPPLY Y BOARD BOARD 15V 15V 63W63W
10.10.   009-003818-00 009-003818-00 Cable Cable for for AC AC input input receptareceptableble
11.11.   115-018611-00 115-018611-00 cardiofax cardiofax signal signal acquisition acquisition board board PCBAPCBA
12.12.   051-001502-00 051-001502-00 M502 M502 Interface Interface board board PCBA(standardPCBA(standard))
13.13.   051-001460-00 051-001460-00 VS VS BABATTERY TTERY Interface Interface board board PCBAPCBA
14.14.   051-001503-00 051-001503-00 M502 M502 USB USB Interface Interface board board PCBAPCBA
15.15.   051-001505-00 051-001505-00 M502 M502 Main Main Keyboard Keyboard PCBAPCBA
16.16.   115-022834-00 115-022834-00 LCD LCD FRUFRU
17.17.   024-000534-00 024-000534-00 Thermal Thermal PrinterPrinter
18.18.   024-000188-00 024-000188-00 antenna antenna 2400-2500MHz 2400-2500MHz 2.15dBI 2.15dBI IPEX-IIIPEX-II
19.19.   020-000014-01 020-000014-01 Spaker Spaker 2W 2W 4ohm 4ohm 500Hz500Hz
20.20.   115-023370-00 115-023370-00 Lens Lens and and touch touch board board FRU(R12)FRU(R12)
21.21.   115-023371-00 115-023371-00 Lens Lens and and touch touch board board FRU(R12A)FRU(R12A)
22.22.   115-02115-022830-02830-00 0 Top Top cover cover FRU(R12 FRU(R12 Lens)Lens)
23.23.   115-022832-00 115-022832-00 Top Top cover cover FRU(R12A FRU(R12A Lens)Lens)
24.24.   115-02115-022831-02831-00 0 Top Top cover cover FRU(R12 FRU(R12 Touch)Touch)
25.25.   021-000132-00 021-000132-00 touch-panel touch-panel resistive resistive 8" 8" 4-line 4-line with with CFCF
26.26.   049-000635-00 049-000635-00 LCD LCD position position blockblock
27.27.   049-000642-00 049-000642-00 PowPower er key(M502 key(M502 silk silk screen)screen)
28.28.   049-000644-00 049-000644-00 Main Main function function key(M502 key(M502 EN EN silk silk screen)screen)
29.29.   M05-010R03--- M05-010R03--- Lithium Lithium battery battery 3V 3V 35mAh 35mAh D12.5*2.0D12.5*2.0
30.30.   043-004288-00 043-004288-00 mid mid frame(R12 frame(R12 universal universal s-screen)s-screen)
31.31.   043-004290-00 043-004290-00 battery battery door(R12 door(R12 universal universal s-screen)s-screen)
32.32.   049-000591-00049-000591-00 USB plugUSB plug（（whitewhite））  
33.33.   043-003531-00 043-003531-00 paper paper bin bin covercover
34.34.   043-003532-00 043-003532-00 paper paper adjust adjust stripstrip
  
  
9-29-2
35.35.   115-022838-00 115-022838-00 Bottom Bottom case case FRUFRU
36.36.   115-022839-00 115-022839-00 Recorder Recorder door door FRUFRU
37.37.   115-022972-00 115-022972-00 Paper Paper bin bin FRU(With FRU(With Hint Hint Label)Label)
38.38.   009-003237-00 009-003237-00 Cable Cable for for PMB PMB to to power power boardboard
39.39.   009-003325-00 009-003325-00 Cable Cable for for to to parameterparameter
40.40.   009-003727-00 009-003727-00 Cable Cable for for MB MB to to keypadkeypad
41.41.   009-003728-00 009-003728-00 Cable Cable for for MB MB to to PMBPMB
42.42.   009-003729-00 009-003729-00 Cable Cable for for MB MB to to 24VDC24VDC
43.43.   009-003730-00 009-003730-00 Cable Cable for for USBUSB
44.44.   009-003731-00 009-003731-00 Cable Cable for for keypadkeypad
45.45.   009-004051-00 009-004051-00 Cable Cable MB MB To To TPBTPB
46.46.   046-004837-00 046-004837-00 R12 R12 Quick Quick Guide Guide (Chinese)(Chinese)
47.47.   046-004838-00 046-004838-00 R12 R12 Quick Quick Guide Guide (English)(English)
48.48.   046-004851-00 046-004851-00 R12 R12 Quick Quick Guide Guide (German)(German)
49.49.   046-004852-00 046-004852-00 R12 R12 Quick Quick Guide Guide (Fre(French)nch)
50.50.   046-004853-00 046-004853-00 R12 R12 Quick Quick Guide Guide (Italian)(Italian)
51.51.   046-004854-00 046-004854-00 R12 R12 Quick Quick Guide Guide (Spanish)(Spanish)
52.52.   046-004855-00 046-004855-00 R12 R12 Quick Quick Guide Guide (Portugue(Portuguese)se)
53.53.   046-004856-00 046-004856-00 R12 R12 Quick Quick Guide Guide (Russian)(Russian)
54.54.   046-004857-00 046-004857-00 R12 R12 Quick Quick Guide Guide (Turkish)(Turkish)
55.55.   046-004858-00 046-004858-00 R12 R12 Quick Quick Guide Guide (Polish)(Polish)
56.56.   046-004859-00 046-004859-00 R12 R12 Quick Quick Guide Guide (Romanish)(Romanish)
57.57.   046-004860-00 046-004860-00 R12 R12 Quick Quick Guide Guide (Hungurian)(Hungurian)
58.58.   046-004861-00046-004861-00 R12 R12 Quick Quick Guide Guide (Czech)(Czech)
59.59.   046-004835-00 046-004835-00 R12 R12 Operator's Operator's Manual Manual (Chinese)(Chinese)
60.60.   046-004836-00 046-004836-00 R12 R12 Operator's Operator's Manual Manual (English)(English)
61.61.   046-004839-00 046-004839-00 R12 R12 Operator'Operator's s Manual Manual (German)(German)
62.62.   046-004840-00 046-004840-00 R12 R12 Operator's Operator's Manual Manual (Fre(French)nch)
63.63.   046-004841-00 046-004841-00 R12 R12 Operator's Operator's Manual Manual (Czech)(Czech)
64.64.   046-004842-00 046-004842-00 R12 R12 Operator's Operator's Manual Manual (Italian)(Italian)
65.65.
  
046-004843-00 046-004843-00 R12 R12 Operator's Operator's Manual Manual (Spanish)(Spanish)
66.66.   046-004844-00 046-004844-00 R12 R12 Operator's Operator's Manual Manual (Portugue(Portuguese)se)
67.67.   046-004846-00 046-004846-00 R12 R12 Operator's Operator's Manual Manual (Russian)(Russian)
68.68.   046-004847-00 046-004847-00 R12 R12 Operator's Operator's Manual Manual (Turkish)(Turkish)
69.69.   046-004848-00 046-004848-00 R12 R12 Operator'Operator's s Manual Manual (Polish)(Polish)
70.70.   046-004849-00 046-004849-00 R12 R12 Operator's Operator's Manual Manual (Romanian)(Romanian)
71.71.   046-004850-00 046-004850-00 R12 R12 Operator's Operator's Manual Manual (Hungarian)(Hungarian)
72.72.   046-006010-00 046-006010-00 BeneHeart BeneHeart R12 R12 service service manual manual (Chinese)(Chinese)
73.73.   046-006011-00 046-006011-00 BeneHeart BeneHeart R12 R12 service service manual manual (English)(English)
74.74.   046-004749-00 046-004749-00 Physician's Physician's Guide, Guide, GlassgowGlassgow
75.75.   046-004817-00 046-004817-00 Glasgow Glasgow ProgrProgram am Physician's Physician's Guide(for Guide(for ElectrocarElectrocardiograph-EN)diograph-EN)
76.76.   115-022979-00 115-022979-00 WIFI WIFI upgrade upgrade packagepackage
77.77.   115-022827-00 115-022827-00 PDF PDF FormaFormat t upgrade upgrade packagepackage
78.78.   115-022828-00 115-022828-00 Glasgow Glasgow upgrade upgrade package(English)package(English)
  
  
9-39-3
79.79.   021-000132-00 021-000132-00 touch-panel touch-panel resistive resistive 8" 8" 4-line 4-line with with CFCF
80.80.   115-004086-00 115-004086-00 Bin Bin kit, kit, no no handle,Thandle,Transportransport
81.81.   043-000383-00 043-000383-00 Base Base covercover
82.82.   034-000090-00 caster034-000090-00 caster
83.83.   043-004231-00 handle043-004231-00 handle
84.84.   043-004233-00 043-004233-00 rolling rolling stand stand buttonbutton
85.85.   043-000382-00 bin,base043-000382-00 bin,base
86.86.   043-004232-00 043-004232-00 yoke yoke holderholder
9.29.2  Parts Change ListParts Change List
Update the service manual according to the latest BOM.Update the service manual according to the latest BOM.
..
  
  
8-88-8
FOR YOUR NOTESFOR YOUR NOTES
  
  
A-1A-1
AA  Electrical Safety InspectionElectrical Safety Inspection
 The following  The following electrical safety electrical safety tests are rtests are recommendecommended as part of a coed as part of a comprehensivmprehensive prevene preventive maintetive maintenance prognance program.ram.
 They are  They are a proven ma proven means of detectineans of detecting abnormalities tg abnormalities that, if undetehat, if undetected, could cted, could prove danprove dangerous to gerous to either the peither the patientatient
or the operator. Additional tests may be required according to local regulations.or the operator. Additional tests may be required according to local regulations.
All tests can All tests can be performed using commercially available safety analyzer test equipment. These procedurbe performed using commercially available safety analyzer test equipment. These procedures assume thees assume the
use of a use of a 601PROXL Internatio601PROXL International Safety Analyzer or nal Safety Analyzer or equivalent safety analyzerequivalent safety analyzer. Other popular . Other popular testers complying withtesters complying with
IEC 60601-1 used in Europe, such as Fluke, Metron, or Gerb, may require modifications to the procedure. Please followIEC 60601-1 used in Europe, such as Fluke, Metron, or Gerb, may require modifications to the procedure. Please follow
the instructions the instructions of the of the analyzer manufactureranalyzer manufacturer..
 The consistent  The consistent use of a safeuse of a safety analyzer ty analyzer as a routine as a routine step in closing step in closing a repair or a repair or upgrade is eupgrade is emphasized as a mphasized as a mandatorymandatory
step if an step if an approved agency status is to be maintained. The safety analyzer also proves to be an excellentapproved agency status is to be maintained. The safety analyzer also proves to be an excellent
troubleshootroubleshooting tool to ting tool to detect abnormalities of line voltage and detect abnormalities of line voltage and groundinggrounding, as , as well as total well as total current loads.current loads.
A.1A.1  Power Cord PlugPower Cord Plug
Test Test Item Item Acceptance Acceptance CriteriaCriteria
 The powe The power plugr plug
 The powe The power plug pins r plug pins No broken or No broken or bent pin. No discbent pin. No discolored pins.olored pins.
 The plug body  The plug body No physical damNo physical damage to the age to the plug bodyplug body..
 The strain r The strain reliefelief
No physical damage to the No physical damage to the strain relief. No plug warmth forstrain relief. No plug warmth for
device in use.device in use.
 The powe The power plug r plug No loose conNo loose connections.nections.
 The powe The power cordr cord
No physical damage to the cord. No deterioration to theNo physical damage to the cord. No deterioration to the
cord.cord.
For devices with detachable power cords, inspect theFor devices with detachable power cords, inspect the
connection at the device.connection at the device.
For devices with non-detachable power cords, inspect theFor devices with non-detachable power cords, inspect the
strain relief at the strain relief at the device.device.
  
  
A-2A-2
A.2A.2  Device Enclosure and AccessoriesDevice Enclosure and Accessories
A.2.1A.2.1  Visual InspectionVisual Inspection
Test Test Item Item Acceptance Acceptance CriteriaCriteria
 The enclosure  The enclosure and accessoriand accessorieses
No physical damage to No physical damage to the enclosure and accessories.the enclosure and accessories.
No physical damage No physical damage to meters, switches, connectors, etc.to meters, switches, connectors, etc.
No residue of fluid spillage (e.g., water, coffee, chemicals, etc.).No residue of fluid spillage (e.g., water, coffee, chemicals, etc.).
No loose or missing parts No loose or missing parts (e.g., knobs, dials, terminals, etc.).(e.g., knobs, dials, terminals, etc.).
A.2.2A.2.2  Contextual InspectionContextual Inspection
Test Test Item Item Acceptance Acceptance CriteriaCriteria
 The enclosure  The enclosure and accessoriand accessorieses
No unusual noises (e.g., a rattle inside the No unusual noises (e.g., a rattle inside the case).case).
No unusual smells (e.g., burning or smoky smells, particularly fromNo unusual smells (e.g., burning or smoky smells, particularly from
ventilation holes).ventilation holes).
No taped notes that may suggest device deficiencies or operatorNo taped notes that may suggest device deficiencies or operator
concerns.concerns.
A.3A.3  Device LabelingDevice Labeling
Check the labels Check the labels provided by the manufacturer or the healthcare facility provided by the manufacturer or the healthcare facility are present and legible.are present and legible.
   Main unit labelMain unit label
   Integrated warning labelsIntegrated warning labels
A.4A.4  Protective Earth ResistanceProtective Earth Resistance
ProtectivProtective Earth e Earth Resistance is measured using the RED Resistance is measuredusing the RED test lead attached to test lead attached to the DUT Protective Earth terminal orthe DUT Protective Earth terminal or
enclosure. Select the test current by pressing SOFT KEY 3 to toggle 25AMP. The front panel outlet power is turned offenclosure. Select the test current by pressing SOFT KEY 3 to toggle 25AMP. The front panel outlet power is turned off
for this test.for this test.
 The following  The following conditions apply: L1 and Lconditions apply: L1 and L2 Open.2 Open.
  
  
A-3A-3
PreparationPreparation
1. 1. First seleFirst select the tct the test curreest current that wnt that will be used ill be used for perforfor performing the ming the Protective Protective Earth ResistancEarth Resistance test be test by pressingy pressing
AMPERES (SOFT KEY 3).AMPERES (SOFT KEY 3).
2. 2. Connect Connect the test the test lead(s) belead(s) between tween the RED the RED input jack input jack and the and the GREEN inpuGREEN input jack.t jack.
3. 3. Press CAL Press CAL LEADS. The LEADS. The 601PRO will 601PRO will measure measure the lead the lead resistance, and resistance, and if less than if less than 0.150 Ohms, i0.150 Ohms, it will store t will store thethe
reading and subtract it from all earth resistance readings taken at the reading and subtract it from all earth resistance readings taken at the calibrated current.calibrated current.
If the calibration fails, the previously stored readings will be used until a If the calibration fails, the previously stored readings will be used until a passing calibration has occurred.passing calibration has occurred.
WARNINGWARNING
   During Earth Resistance testing, the DUT must be plugged During Earth Resistance testing, the DUT must be plugged into the 601PRO front outlet. Ifinto the 601PRO front outlet. If
the DUT fails Earth Resistance, discontinue tests and label ththe DUT fails Earth Resistance, discontinue tests and label the device defective.e device defective.
 To  To Perform tPerform the The Testest
1. 1. From tFrom the MAIN Mhe MAIN MENU, or wENU, or with the oith the outlet unpowutlet unpowered, plug ered, plug the DUT the DUT into the into the 601PRO fron601PRO front panel outt panel outlet.let.
2. 2. Attach the Attach the 601PRO RED 601PRO RED input lead input lead to the dto the device’s Proevice’s Protective Eartective Earth terminath terminal or an l or an exposed mexposed metal area.etal area.
3. 3. Press Press shortcut shortcut key 3. key 3. The PThe Protective rotective Earth Earth Resistance Resistance test is test is displayed.displayed.
4. 4. Press SOFPress SOFT KEY 3 to select T KEY 3 to select a test curra test current (25AMP). The ent (25AMP). The selected teselected test current is st current is displayed in the displayed in the upper right upper right cornercorner
of the display.of the display.
5. 5. Press START Press START TEST to stTEST to start the art the test. The tetest. The test currest current is applied nt is applied while resistancwhile resistance and cure and current rearent readings are dings are taken. Thistaken. This
takes approximately 5 seconds.takes approximately 5 seconds.
6. 6. Press the Press the print data keprint data key at any y at any time to time to generate generate a printout a printout of the latof the latest measurest measurement(s).ement(s).
NOTENOTE
   When "Over" is displayed for Ohms, this signifies that When "Over" is displayed for Ohms, this signifies that a valid measurement was nota valid measurement was not
obtained because either an open connection was detected obtained because either an open connection was detected or that the measurement was or that the measurement was notnot
within range. Readings greater than 9.999 Ohms will within range. Readings greater than 9.999 Ohms will be displayed as Over.be displayed as Over.
  
  
A-4A-4
In Case of FailureIn Case of Failure
Once it reaches the limitation, stop using and inform the Customer Service Engineer for analysis and disposal.Once it reaches the limitation, stop using and inform the Customer Service Engineer for analysis and disposal.
LIMITSLIMITS
ALL COUNTRIES R = 0.2 Ω MALL COUNTRIES R = 0.2 Ω Maximumaximum
A.5A.5  Earth Leakage TestEarth Leakage Test
Run an Earth Run an Earth Leakage test on the device being tested before performing any otheLeakage test on the device being tested before performing any other leakage tests.r leakage tests.
Leakage current is measured the following ways:Leakage current is measured the following ways:
   Earth Leakage Current, leakage current measured through DUT outlet EarthEarth Leakage Current, leakage current measured through DUT outlet Earth
   Earth Leakage Current AP-EARTH (ALL Applied Parts connected to Earth Leakage Current AP-EARTH (ALL Applied Parts connected to Earth), leakage current measured through DUTEarth), leakage current measured through DUT
outlet Earthoutlet Earth
 There is no  There is no need to attacneed to attach a test lead; th a test lead; the 601PRO auhe 601PRO automatically ctomatically connects the meonnects the measuring device asuring device internallyinternally..
 To  To Perform tPerform the The Testest
1. 1. From From the Mthe MAIN MEAIN MENU, NU, or or with the with the outlet uoutlet unpowered, npowered, plug the plug the DUT DUT into into the 601PRO the 601PRO front front panel panel outlet,outlet,
and turn on the device.and turn on the device.
2. 2. Attach Attach the the device's device's applied applied parts parts to to the the 601PRO 601PRO applied applied part part terminals terminals if if applicable.applicable.
3. 3. Press Press shortcut shortcut key key 4.The 4.The Earth LEarth Leakage teakage test est appears appears on on the the display, display, and and the testhe test t begins begins immediately:immediately:
   SOFT KEY 1 toggles the DUT outlet Polarity from Normal to Off SOFT KEY 1 toggles the DUT outlet Polarity from Normal to Off to Reverse.to Reverse.
   SOFT KEY 2 toggles the DUT outlet from Earth SOFT KEY 2 toggles the DUT outlet from Earth to No Earth.to No Earth.
   SOFT KEY 3 toggles the DUT outlet from SOFT KEY 3 toggles the DUT outlet from L2 to No L2.L2 to No L2.
   SOFT KEY 4 toggles the AP to Earth to No AP to Earth.SOFT KEY 4 toggles the AP to Earth to No AP to Earth.
4. 4. Press the Press the print data keprint data key at any y at any time to time to generate generate a printout a printout of the latof the latest measurest measurement.ement.
  
  
A-5A-5
In Case of FailureIn Case of Failure
   Check any broken of the enclosure. Replace any defective part.Check any broken of the enclosure. Replace any defective part.
   Inspect wiring for bad crimps, poor connections, or damage.Inspect wiring for bad crimps, poor connections, or damage.
    Test the wall o Test the wall outlet; verify iutlet; verify it is grounded t is grounded and is free oand is free of other wirf other wiring abnormalitieing abnormalities. Notify the uses. Notify the user or owner r or owner toto
correct any deviations. As a work around, check the correct any deviations. As a work around, check the other outlets to see if they could be other outlets to see if they could be used instead.used instead.
   Change another probe to confirm if the fail Change another probe to confirm if the fail is caused by console.is caused by console.
   If the leakage current measuremeIf the leakage current measurement tests fail on nt tests fail on a new unit and a new unit and if situation can not if situation can not be corrected, submit a Safetybe corrected, submit a Safety
Failure Report to document the system problem. Remove unit Failure Report to document the system problem. Remove unit from operation.from operation.
   If all else fails, If all else fails, stop using and inform the Customer Service Engineer for analysis and disposal.stop using and inform the Customer Service Engineer for analysis and disposal.
LIMITSLIMITS
For UL60601-1,For UL60601-1,
   300 μA in 300 μAin Normal ConditionNormal Condition
   1000 μA in Single Fault Condition1000 μA in Single Fault Condition
For IEC60601-1,For IEC60601-1,
   500 μA in 500 μA in Normal ConditionNormal Condition
   1000 μA in Single Fault Condition1000 μA in Single Fault Condition
A.6A.6  Patient Leakage CurrentPatient Leakage Current
Patient leakage currenPatient leakage currents are measured between a selected applied part and mains ts are measured between a selected applied part and mains earth. All measurements have aearth. All measurements have a
true RMS only response.true RMS only response.
PreparationPreparation
Perform a calibration from the Mains on Applied Part menu.Perform a calibration from the Mains on Applied Part menu.
 The following  The following outlet condoutlet conditions apply when itions apply when performing this performing this test:test:
   Normal Normal Polarity, Polarity, Earth Earth Open, OOpen, Outlet Outlet ON N Normal Normal Polarity, Polarity, Outlet Outlet ONON
   Normal Normal Polarity, Polarity, L2 L2 Open, Open, Outlet Outlet ON ON Reversed Reversed Polarity, Polarity, Outlet Outlet ONON
   Reversed Polarity, Earth Open, Outlet ON Reversed Polarity, Earth Open, Outlet ON Reversed Polarity, L2 Open, Outlet ONReversed Polarity, L2 Open, Outlet ON
WARNINGWARNING
   If all of the applied parts If all of the applied parts correspond to the instrument type, the applied parts correspond to the instrument type, the applied parts will be tiedwill be tied
together and one reading will be taken. If any of the applied parts differ from thetogether and one reading will be taken. If any of the applied parts differ from the
instrument type, all applied parts will be instrument type, all applied parts will be tested individually, based on the type of appliedtested individually, based on the type of applied
part. This applies to Auto and Step part. This applies to Auto and Step modes only.modes only.
  
  
A-6A-6
To Perform the TestTo Perform the Test
1. 1. From the From the MAIN MENU, MAIN MENU, or with the or with the outlet unpowered, plug outlet unpowered, plug the DUT into the DUT into the 601PRO front the 601PRO front panel outlet, panel outlet, andand
turn on the device.turn on the device.
2. 2. Attach Attach the applied the applied parts parts to the to the 601PRO's 601PRO's applied applied part termpart terminals.inals.
3. 3. Press shoPress shortcut key rtcut key 6. The 6. The Patient Leakage Patient Leakage test is test is displayed, and displayed, and the test the test begins immediately.begins immediately.
4. 4. Press APPLPress APPLIED PART IED PART (SOFT KEY (SOFT KEY 4) at any 4) at any time to time to select the select the desired appdesired applied part lelied part leakage curreakage current.nt.
5. 5. Modify the Modify the configuration configuration of the frof the front panel ouont panel outlet by ptlet by pressing the ressing the appropriate appropriate SOFT KEY oSOFT KEY on the 601PRn the 601PRO.O.
6. 6. Press the Press the print data keprint data key at any y at any time to time to generate generate a printout a printout of the latof the latest measurest measurement.ement.
In Case of FailureIn Case of Failure
   Check any broken of the enclosure. Replace any defective part.Check any broken of the enclosure. Replace any defective part.
   Inspect wiring for bad crimps, poor connections, or damage.Inspect wiring for bad crimps, poor connections, or damage.
    Test the wall o Test the wall outlet; verify it utlet; verify it is grounded is grounded and is free oand is free of other wirf other wiring abnormalitieing abnormalities. Notify the uses. Notify the user or owner r or owner toto
correct any deviations. As a work around, check the correct any deviations. As a work around, check the other outlets to see if they could be other outlets to see if they could be used instead.used instead.
   Change another probe to confirm if the fail Change another probe to confirm if the fail is caused by console.is caused by console.
   If the leakage current measuremeIf the leakage current measurement tests fail on nt tests fail on a new unit and if a new unit and if situation can not be corrected, submit a Safetysituation can not be corrected, submit a Safety
Failure Report to document the system problem. Remove unit Failure Report to document the system problem. Remove unit from operation.from operation.
   If all else fails, If all else fails, stop using and inform the Customer Service Engineer for analysis and disposal.stop using and inform the Customer Service Engineer for analysis and disposal.
LIMITSLIMITS
For For CF CF applied applied partsparts
   10μA in Normal Condition10μA in Normal Condition
   50μA in Single Fault Condition50μA in Single Fault Condition
  
  
A-7A-7
A.7A.7  Mains on Applied Part LeakageMains on Applied Part Leakage
 The Mains on Applied  The Mains on Applied Part test appPart test applies a test voltalies a test voltage, which is 110% ge, which is 110% of the mains of the mains voltage, thvoltage, through a limitrough a limitinging
resistanceresistance, to , to selected applied part selected applied part terminals. Curreterminals. Current measurements are then taken between the selected appliednt measurements are then taken between the selected applied
part and earth. part and earth. MeasuremenMeasurements are taken ts are taken with the test with the test voltage voltage (110% of mains) to (110% of mains) to applied parts in the noapplied parts in the normal andrmal and
reverse polarity conditions as indicated on the reverse polarity conditions as indicated on the display.display.
 The following  The following outlet condoutlet conditions apply when itions apply when performing the performing the Mains on Applied PMains on Applied Part test.art test.
   Normal Polarity;Normal Polarity;
   Reversed PolarityReversed Polarity
PreparationPreparation
 To  To perform a calibraperform a calibration from ttion from the Mains on Applied Phe Mains on Applied Part test, press art test, press CAL (SOFT KECAL (SOFT KEY 2).Y 2).
1. 1. Disconnect Disconnect ALL ALL patient patient leads, tleads, test est leads, leads, and Dand DUT oUT outlet utlet connections.connections.
2. 2. Press Press CAL CAL to to begin begin calibration, calibration, as as shown:shown:
If the calibration fails, the prIf the calibration fails, the previously stored reeviously stored readings will be used until a passing adings will be used until a passing calibration has occurrecalibration has occurred. Also,d. Also,
the esc/stop key has no effect during calibration.the esc/stop key has no effect during calibration.
3. 3. When the When the calibration calibration is finished, is finished, the Mains the Mains on Applieon Applied Part d Part test test will reapwill reappear.pear.
WARNINGWARNING
   A 2-beep-per-second signal indicates high voltage present at the A 2-beep-per-second signal indicates high voltage present at the applied part terminalsapplied part terminals
while a calibration is being performed.while a calibration is being performed.
   High voltage is present at applied part High voltage is present at applied part terminals while measurements are being taken.terminals while measurements are being taken.
  
  
A-8A-8
To Perform the TestTo Perform the Test
1. 1. From From the MAIN the MAIN MENU, or MENU, or with the with the outlet unpooutlet unpowered, wered, plug the plug the DUT into DUT into the 601the 601
2. 2. Attach Attach the the applied applied parts parts to tto the 601Phe 601PRO RO applied applied part part terminals.terminals.
3. 3. Attach the Attach the red tered terminal lead rminal lead to a to a conductive conductive part on part on the DUT the DUT enclosure.enclosure.
4. 4. Press Press shortcut shortcut key 7. key 7. The Mains The Mains on Applieon Applied Part d Part test is test is displayed.displayed.
5. 5. Select the Select the desired oudesired outlet configurtletconfiguration and apation and applied part tplied part to test uo test using the asing the appropriate Sppropriate SOFT KEYS:OFT KEYS:
6. 6. Press Press START START TEST TEST (SOFT (SOFT KEY 1) KEY 1) to to begin begin the the test.test.
7. 7. Press thPress the print e print data key data key to geneto generate a rate a printout oprintout of the f the latest mlatest measurement.easurement.
NOTENOTE
   If all of the applied parts If all of the applied parts correspond to the instrument type, the applied parts correspond to the instrument type, the applied parts will be tiedwill be tied
together and one reading will be taken. If any of the applied parts differ from thetogether and one reading will be taken. If any of the applied parts differ from the
instrument type, all applied parts will be instrument type, all applied parts will be tested individually, based on the type of appliedtested individually, based on the type of applied
part. This applies to Auto and Step part. This applies to Auto and Step modes only.modes only.
In Case of FailureIn Case of Failure
   Check any broken of the enclosure. Replace any defective part.Check any broken of the enclosure. Replace any defective part.
   Inspect wiring for bad crimps, poor connections, or damage.Inspect wiring for bad crimps, poor connections, or damage.
    Test the wall o Test the wall outlet; verify it utlet; verify it is grounded is grounded and is free oand is free of other wirf other wiring abnormalitieing abnormalities. Notify the uses. Notify the user or owner r or owner toto
correct any deviations. As a work around, check the correct any deviations. As a work around, check the other outlets to see if they could be other outlets to see if they could be used instead.used instead.
   Change another probe to confirm if the fail Change another probe to confirm if the fail is caused by console.is caused by console.
   If the leakage current measuremeIf the leakage current measurement tests fail on nt tests fail on a new unit and if a new unit and if situation can not be corrected, submit a Safetysituation can not be corrected, submit a Safety
Failure Report to document the system problem. Remove unit Failure Report to document the system problem. Remove unit from operation.from operation.
   If all else fails, If all else fails, stop using and inform the Customer Service Engineer for analysis and disposal.stop using and inform the Customer Service Engineer for analysis and disposal.
LIMITSLIMITS
   For For CF CF applied applied parts: parts: 50 50 μAμA
  
  
A-9A-9
A.8A.8  Patient Auxiliary CurrentPatient Auxiliary Current
Patient Auxiliary currents are measured between any selected ECG jack and the remaining selected ECG jacks. AllPatient Auxiliary currents are measured between any selected ECG jack and the remaining selected ECG jacks. All
measurements may have a true RMS only response.measurements may have a true RMS only response.
PreparationPreparation
1. 1. From thFrom the MAIN MEe MAIN MENU, or wNU, or with the oith the outlet unpoweutlet unpowered, plug red, plug the DUT intthe DUT into the 601Po the 601PRO front RO front panel outletpanel outlet, and turn, and turn
on the device.on the device.
2. 2. Attach Attach the the patient patient leads leads to to the the 601PRO 601PRO ECG ECG jacks.jacks.
3. 3. Define the LDefine the Lead Types fread Types from the Vieom the View Settings Ow Settings Option (refer ption (refer to: Lead Type to: Lead Type Definitions in SecDefinitions in Section 5 of this chapttion 5 of this chapter).er).
4. 4. Press shortPress shortcut key cut key 8. The Patie8. The Patient Auxiliary nt Auxiliary Current teCurrent test is displayest is displayed, and the d, and the test begtest begins immedins immediately. Displayiately. Display
values are continuously updated until another test is selected.values are continuously updated until another test is selected.
5. 5. Press Press SOFT SOFT KEYS KEYS 1-4 1-4 to to select select leakage leakage teststests
6. 6. Press APPLPress APPLIED PART IED PART (SOFT KEY (SOFT KEY 4) at any 4) at any time to time to select the select the desired appdesired applied part lelied part leakage curreakage current:nt:
7. 7. Modify the Modify the configuration configuration of the frof the front panel ouont panel outlet by ptlet by pressing the ressing the appropriate appropriate SOFT KEY oSOFT KEY on the 601PROn the 601PRO::
8. 8. Press the Press the print data keprint data key at any y at any time to time to generate generate a printout a printout of the latof the latest measurest measurement.ement.
In Case of FailureIn Case of Failure
   Check any broken of the enclosure. Replace any defective part.Check any broken of the enclosure. Replace any defective part.
   Inspect wiring for bad crimps, poor connections, or damage.Inspect wiring for bad crimps, poor connections, or damage.
    Test the wall o Test the wall outlet; verify iutlet; verify it is grounded t is grounded and is free oand is free of other wirf other wiring abnormalitieing abnormalities. Notify the uses. Notify the user or owner r or owner toto
correct any deviations. As a work around, check the correct any deviations. As a work around, check the other outlets to see if they could be other outlets to see if they could be used instead.used instead.
   Change another probe to confirm if the fail Change another probe to confirm if the fail is caused by console.is caused by console.
   If the leakage current measuremeIf the leakage current measurement tests fail on nt tests fail on a new unit and a new unit and if situation cannot be corrected, submit a Safetyif situation cannot be corrected, submit a Safety
Failure Report to document the system problem. Remove unit Failure Report to document the system problem. Remove unit from operation.from operation.
   If all else fails, If all else fails, stop using and inform the Customer Service Engineer for analysis and disposal.stop using and inform the Customer Service Engineer for analysis and disposal.
LIMITSLIMITS
For For CF CF applied applied parts,parts,
   10μA in Normal Condition10μA in Normal Condition
   50μA in Single Fault Condition50μA in Single Fault Condition
  
  
A-10A-10
A.9A.9  Scheduled Electrical Safety InspectionScheduled Electrical Safety Inspection
For scheduleFor scheduled electrical safety inspection, test items 1, 2, 3, 4, 5, 6, d electrical safety inspection, test items 1, 2, 3, 4, 5, 6, 7, and 8 included in the7, and 8 included in the ELECTRICAL SAFETYELECTRICAL SAFETY
INSPECTION FORMINSPECTION FORM shall be  shall be performed.performed.
ELECTRICAL SAFETY INSPECTION FORMELECTRICAL SAFETY INSPECTION FORM
Location: Technician:Location: Technician:
Equipment: Equipment: Control Control Number:Number:
Manufacturer: Manufacturer: Model: Model: SN:SN:
Measurement Measurement equipment equipment /SN: /SN: Date Date of of Calibration:Calibration:
INSPECTION INSPECTION AND AND TESTING TESTING Pass/Fail Pass/Fail LimitLimit
1 1 Power Power Cord Cord PlugPlug
2 2 Device Device Enclosure Enclosure and and AccessorieAccessoriess
3 3 Device Device LabelingLabeling
4 4 ProtectivProtective e Earth Earth Resistance Resistance Ω Ω Max Max 0.2 0.2 ΩΩ
5 5 Earth Earth LeakageLeakage
Normal condition (NC)Normal condition (NC) ____μA____μA
Max:Max:
NC: 300μA(refer toNC: 300μA(refer to
UL60601-1) *UL60601-1) *
NC: 500μA(refer toNC: 500μA(refer to
IEC60601-1) *IEC60601-1) *
SFC: 1000μASFC: 1000μA
Single Fault conditionSingle Fault condition
(SFC)(SFC)
____μA____μA
66
Patient LeakagePatient Leakage
CurrentCurrent
Normal condition (NC)Normal condition (NC)
□□BF____μABF____μA
Max:Max:
CF applied part:CF applied part:
NC:10μA, SFC: 50μANC:10μA, SFC: 50μA
□□CF____μACF____μA
Single Fault conditionSingle Fault condition
(SFC)(SFC)
□□BF____μABF____μA
□□CF____μACF____μA
7 7 Mains Mains on on Applied Applied Part Part LeakageLeakage
□□BF____μABF____μA
Max:Max:
CF appliedpart: 50μACF applied part: 50μA□□CF____μACF____μA
88
PatientPatient
AuxiliaryAuxiliary
CurrentCurrent
Normal condition (NC)Normal condition (NC)
□□BF____μABF____μA
Max:Max:
CF applied part:CF applied part:
NC:10μA, SFC: 50μANC:10μA, SFC: 50μA
□□CF____μACF____μA
Single Fault condition (SFC)Single Fault condition (SFC)
□□BF____μABF____μA
□□CF____μACF____μA
NoteNote: The equipment sold to the United States shall comply with the requirement of UL60601-1; others shall comply: The equipment sold to the United States shall comply with the requirement of UL60601-1; others shall comply
with the requirement of IEC60601-1.with the requirement of IEC60601-1.
Name/ Signature: __________________________ Date:_____________________________Name/ Signature: __________________________ Date:_____________________________
  
  
A-11A-11
A.10A.10  Electrical Safety Inspection after RepairElectrical Safety Inspection after Repair
 The following  The following table specifies ttable specifies test items to est items to be performed be performed after the eqafter the equipment is ruipment is repaired.epaired.
Repair Repair with with main main unit unit not not disassembled disassembled TeTest st items: items: 1, 1, 2, 2, 33
Repair withRepair with
main unitmain unit
disassembleddisassembled
When neither power supply PCBA norWhen neither power supply PCBA nor
patient electrically-connected PCBA ispatient electrically-connected PCBA is
repaired or replacedrepaired or replaced
 Te Test items: 1, 2, 3, 4st items: 1, 2, 3, 4
When power supply PCBA is repaired orWhen power supply PCBA is repaired or
replacedreplaced
 Te Test items: 1, 2, 3, 4, 5st items: 1, 2, 3, 4, 5
When patient electrically-connected PCBA isWhen patient electrically-connected PCBA is
repaired or replacedrepaired or replaced
 Te Test items: 1, 2, 3, 4, 6, 7, st items: 1, 2, 3, 4, 6, 7, 88
When both power supplyWhen both power supply
PCBA and PCBA and patient electrically-connectedpatient electrically-connected
PCBA are repaired or replacedPCBA are repaired or replaced
 Te Test items: 1, 2, 3, 4, 5, 6, st items: 1, 2, 3, 4, 5, 6, 7, 87, 8
  
  
A-12A-12
ELECTRICAL SAFETY INSPECTION FORMELECTRICAL SAFETY INSPECTION FORM
Location: Technician:Location: Technician:
Equipment: Equipment: Control Control Number:Number:
Manufacturer: Manufacturer: Model: Model: SN:SN:
Measurement Measurement equipment equipment /SN: /SN: Date Date of of Calibration:Calibration:
INSPECTION INSPECTION AND AND TESTING TESTING Pass/Fail Pass/Fail LimitLimit
1 1 Power Power Cord Cord PlugPlug
2 2 Device Device Enclosure Enclosure and and AccessorieAccessoriess
3 3 Device Device LabelingLabeling
4 4 ProtectivProtective e Earth Earth Resistance Resistance Ω Ω Max Max 0.2 0.2 ΩΩ
5 5 Earth Earth LeakageLeakage
Normal condition(NC)Normal condition(NC) ____μA____μA
Max:Max:
NC: 300μA(refer toNC: 300μA(refer to
UL60601-1) *UL60601-1) *
NC: 500μA(refer toNC: 500μA(refer to
IEC60601-1) *IEC60601-1) *
SFC: 1000μASFC: 1000μA
Single FaultSingle Fault
condition(SFC)condition(SFC)
____μA____μA
66
Patient LeakagePatient Leakage
CurrentCurrent
Normal condition(NC)Normal condition(NC)
□□BF____μABF____μA
Max:Max:
CF applied part:CF applied part:
NC:10μA, SFC: 50μANC:10μA, SFC: 50μA
□□CF____μACF____μA
Single FaultSingle Fault
condition(SFC)condition(SFC)
□□BF____μABF____μA
□□CF____μACF____μA
7 7 Mains Mains on on Applied Applied Part Part LeakageLeakage
□□BF____μABF____μA
Max:Max:
CF applied part: 50μACF applied part: 50μA□□CF____μACF____μA
88
PatientPatient
AuxiliaryAuxiliary
CurrentCurrent
Normal condition(NC)Normal condition(NC)
□□BF____μABF____μA
Max:Max:
CF applied part:CF applied part:
NC:10μA, SFC: 50μANC:10μA, SFC: 50μA
□□CF____μACF____μA
Single Fault condition(SFC)Single Fault condition(SFC)
□□BF____μABF____μA
□□CF____μACF____μA
NoteNote: The equipment sold to the United States shall comply with the requirement of UL60601-1; others shall comply: The equipment sold to the United States shall comply with the requirement of UL60601-1; others shall comply
with the requirement of IEC60601-1.with the requirement of IEC60601-1.
Name/ Signature: __________________________ Date:_____________________________Name/ Signature: __________________________ Date:_____________________________
  
  
  
  
P/N: 046-006011-00P/N: 046-006011-00（（22.0.0））