EDAN iM3 Service Manual
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EDAN iM3 Service Manual

Vital signs monitor
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EDAN Agile PLM Electronic Signature Information
--Signatures related to this document and performed in EDAN Agile PLM.
文件名称(Document Name)：iM3 维修手册_英文
文件编号(Number)：01.54.457834
版本(Version)：1.1
产品型号(Product Model)：iM3
项目编码(Project Code)：00004I002
签批信息(Signature):
作者(Originator) : 陈 艳娟 (chenyanjuan)
2018-02-07 10:15:49
审核人(Reviewers) : 程 亮 (chengliang)
2018-02-07 11:33:42
审核人(Reviewers) : 史 洪华 (shihonghua)
2018-02-07 11:28:34
审核人(Reviewers) : 韦 华彪 (weihuabiao)
2018-02-07 15:36:37
审核人(Reviewers) : 陈 良款 (chenliangkuan)
2018-02-07 14:08:44
批准人(Approvers) : 夏 欢欢 (xiahuanhuan)
2018-02-24 13:16:16
批准人(Approvers) : 陈 浩杰 (chenhaojie)
2018-02-23 15:21:15
版权©深圳市理邦精密仪器股份有限公司 (Copyright©Edan Instrument,Inc.)

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Summary of Contents for EDAN iM3

  • Page 1 EDAN Agile PLM Electronic Signature Information --Signatures related to this document and performed in EDAN Agile PLM. 文件名称(Document Name)：iM3 维修手册_英文 文件编号(Number)：01.54.457834 版本(Version)：1.1 产品型号(Product Model)：iM3 项目编码(Project Code)：00004I002 签批信息(Signature): 作者(Originator) : 陈 艳娟 (chenyanjuan) 2018-02-07 10:15:49 审核人(Reviewers) : 程 亮 (chengliang) 2018-02-07 11:33:42 审核人(Reviewers) : 史...
  • Page 3 This manual will help you understand the operation and maintenance of the product better. It is reminded that the product shall be used strictly complying with this manual. User’s operation failing to comply with this manual may result in malfunction or accident for which EDAN INSTRUMENTS, INC. (hereinafter called EDAN) can not be held liable.
  • Page 4 Terms Used in this Manual This guide is designed to give key concepts on safety precautions. WARNING: A WARNING label advises against certain actions or situations that could result in personal injury or death. CAUTION: A CAUTION label advises against actions or situations that could damage equipment, produce inaccurate data, or invalidate a procedure.

  • Page 5: Table Of Contents

    Table of Contents Chapter 1 Warranty and Service ....................1 Chapter 2 Safety Guidance ......................4 2.1 Introduction ........................4 2.2 General Information ......................4 2.3 Safety Precautions ......................4 2.4 Explanation of Symbols on the Monitor ................6 Chapter 3 Installation ........................8 3.1 Environment Requirements ....................
  • Page 6 8.5.5 Replacing Sensor Board of Main Unit ..............51 8.6 Disassembling the Plug-in Module .................. 52 8.6.1 Replacing iM3 T2A Isolation Board/T2A Main Control Board ......54 8.6.2 Replacing Quick TEMP Module/M3 Covidien TEMP Module Communication Isolation Board ........................ 56 8.6.3 Replacing the Isolation Board of M3 Infrared Ear TEMP ........

  • Page 7: Chapter 1 Warranty And Service

    Limitation of Warranty Direct, indirect or final damage and delay caused by the following situations for which EDAN is not responsible may void the warranty:  Groupware is dismounted, stretched or redebugged.
  • Page 8 After receiving the RMA form from the service department, the customer sends defective parts to EDAN in advance. We will analyze the problems and discuss with the customer about either repairing or replacing the part (s). Once the maintenance fee is invoiced and paid, we will make sure to dispatch good part (s) to the confirmed address.
  • Page 9 Vital Signs Monitor Service Manual Warranty and Service Contact Information If you have any question about maintenance, technical specifications or malfunctions of devices, do not hesitate to contact us. EDAN INSTRUMENTS, INC. TEL: +86-755-26898321, 26899221 FAX: +86-755-26882223, 26898330 E-mail: support@edan.com.cn - 3 -...

  • Page 10: Chapter 2 Safety Guidance

    2.2 General Information The iM3 Vital Signs Monitor (hereinafter called monitor) is designed in accordance with the international safety requirements in IEC/ EN 60601-1 for medical electrical equipment. Classification information of this equipment is as follows:...
  • Page 11 Vital Signs Monitor Service Manual Safety Guidance WARNING 3 The service personnel must be familiar with the operation of this monitor. Refer to iM3 Vital Signs Monitor User Manual for details. 4 Perform periodic safety test to ensure patient safety. Safety tests should include leakage current measurement and insulation testing.

  • Page 12: Explanation Of Symbols On The Monitor

    Vital Signs Monitor Service Manual Safety Guidance 2.4 Explanation of Symbols on the Monitor DEFIBRILLATION-PROOF TYPE BF APPLIED PART TYPE BF APPLIED PART Caution MR Unsafe - Keep away from magnetic resonance imaging (MRI) equipment Equipotential grounding Power Supply switch SERIAL NUMBER Network port USB (Universal Serial Bus) Connection...
  • Page 13 Vital Signs Monitor Service Manual Safety Guidance Disposal method Operating instructions Refer to User Manual (Background: Blue; Symbol: White) Warning (Background: Yellow; Symbol & outline: black) Ingress Protection IPX1 (Protected against vertically falling water drops) Caution: Federal (U.S.) Law restricts this device to sale by or on the order of a physician.

  • Page 14: Chapter 3 Installation

    Vital Signs Monitor Service Manual Installation Chapter 3 Installation WARNING Only qualified service engineers shall install this equipment. 3.1 Environment Requirements Temperature 0 C ~ +40 C (32 ℉~104 ℉) Working With TEMP: +10 C ~ +40 C (50 ℉~104 ℉) -20 C ~ +55 C (-4 ℉~131 ℉) Transport and storage With TH module: -20 C ~ +50 C (-4 ℉~122 ℉)

  • Page 15: Safety Requirements

     To install the monitor on a flat surface Place the monitor on a flat surface. Make sure the surface does not vibrate, and is free of corrosive medicine and dust. Figure 3-1 iM3 on a flat surface - 9 -...

  • Page 16: Connecting To Ac Power Supply

    Vital Signs Monitor Service Manual Installation  To mount the monitor on wall To mount the monitor on a wall, you need to order a Wall Mounting Bracket (02.04.243472). Please refer to that instruction for details of installation. WARNING The wall mounting bracket can be fixed only on a concrete wall. Make sure the monitor is secure on the wall-mounting bracket before releasing your hands from the monitor.

  • Page 17: Chapter 4 Test And Maintenance

    Press the keys on the front panel in turn to check if they work properly. When pressing a key, a corresponding functional display is supposed to be seen onscreen. Refer to iM3 Vital Signs Monitor User Manual for details about the key function. The user can move the cursor by turning the trim knob clockwise or anticlockwise.

  • Page 18: Recording Test

    Vital Signs Monitor Service Manual Test and Maintenance If any failure is detected, refer to Section Operation Failures for details. NOTE: Prior to use, please ensure the scanner is normally installed and set. 4.1.6 Recording Test Check if the recorder can perform printing without problem. Also, check if all the printed traces are correct and clear on the paper.

  • Page 19: Nibp Functional Test

    Access Menu > User Maintain by inputting the password ABC. Start a leakage test by selecting NIBP > Leak Test. For EDAN module: The system will automatically inflate the pneumatic system to about 180 mmHg. After 20 seconds to 40 seconds, if system leakage has detected, the system will automatically open the deflating valve to stop the leak test and indicates NIBP Leak.

  • Page 20: Nibp Calibration

    Figure 4-1 Diagram for NIBP Leakage Test 4.2.4 NIBP Calibration NOTE: NIBP calibration must be performed by professional personnel authorized by EDAN. NIBP calibration can influence measurement results. Incorrect operation may influence measurement accuracy. Tools required: •...

  • Page 21: Nibp Accuracy Test

    Vital Signs Monitor Service Manual Test and Maintenance keep the value of the manometer consistent with the one displayed on the monitor). After the value of the manometer stabilizes, select Calibrate High. 7. Select Calibrate Confirm. 8. Select Calibrate Protection Unit. 9.

  • Page 22: Temp Functional Test

    Vital Signs Monitor Service Manual Test and Maintenance 4.2.6 TEMP Functional Test This test checks the function of the TEMP measurement. For T2A TEMP module: Switch on the monitor and the resistance box. Connect the probe with the resistance box. Set the resistance value to (9571Ω) 26 ℃...

  • Page 23: Safety Test

    Vital Signs Monitor Service Manual Test and Maintenance 4.3 Safety Test 4.3.1 Safety Test Procedures Use the test procedures outlined here only for verifying safe installation or service of the product. These tests are not a substitute for local safety testing where it is required for an installation or a service event.

  • Page 24: Protective Earth Resistance

    Vital Signs Monitor Service Manual Test and Maintenance 4.3.2 Protective Earth Resistance NOTE: The circuit diagram is based on the Fluke 601Pro series safety analyzer. This measures impendence of Protective Earth (PE) terminal to accessible metal part of Device under test (DUT) which is protectively earthed. A current of 25A is passed for 5s to 10s through the protective terminal and each accessible metal part which is protectively earthed.

  • Page 25: Enclosure Leakage Current

    Vital Signs Monitor Service Manual Test and Maintenance 4.3.3 Enclosure Leakage Current NOTE: The circuit diagram is based on the Fluke 601Pro series safety Analyzer. This measures leakage current of exposed metal parts of Device under test (DUT) and parts of the system within the patient environment;...

  • Page 26: Patient Leakage Current

    Vital Signs Monitor Service Manual Test and Maintenance 4.3.4 Patient Leakage current NOTE: The circuit diagram is based on the Fluke 601Pro series safety Analyzer. This test measure the leakage current flowing between the selected applied part and the mains PE; the test with normal and reverse polarity, in normal condition and single fault condition.

  • Page 27: Patient Leakage Current- Single Fault Condition (S.f.c) Mains On Applied Part

    Vital Signs Monitor Service Manual Test and Maintenance Leakage Current Applied Normal Single Fault Part Condition Condition Earth Leakage Current <0.5 mA <1 mA Enclosure Leakage Current <0.1 mA <0.5 mA AC: <0.01 mA AC: <0.05 mA DC: <0.01 mA DC: <0.05 mA Patient Leakage Current AC: <0.1 mA...

  • Page 28: Maintenance

    (IEC/EN 60601-1 UL 60601-1) 4.4 Maintenance For details about basic cleaning and maintenance methods, refer to relevant sections in iM3 Vital Signs Monitor User Manual. For further technical support, contact service engineers of EDAN. Users are responsible for preventive maintenance and periodic inspection for the monitor.

  • Page 29: Maintenance Of The Monitor

    Remove the dust over the printing paper inductor and the sensor with a piece of a dry cloth. CAUTION Only use the printing paper supplied by EDAN, or damage may happen to the recorder. Warranty is void in case of damage caused by this.

  • Page 30: Chapter 5 System Configuration

    5.1 Enter Factory Maintain Enter Menu > Factory Maintain > input password 998 and confirm. Factory maintenance is only available for the service engineers of EDAN or representatives authorized by EDAN.  Module Select: to select NIBP, Quick TEMP and SpO module, and to switch the functions on/off, including recorder, Wi-Fi, encrypt and e-link.

  • Page 31: Default Configuration

    Vital Signs Monitor Service Manual System Configuration 5.3 Default Configuration Press the Menu > Default Setup to display the default setup menu. NOTE: Select any item in this submenu to cancel the current setup and use the selected default setup. ...

  • Page 32: Chapter 6 Principle Introduction

    SpO2 sensor board Printer switching Battery, board SUNTECH Bluetooth board Printer Figure 6-1 iM3 System Principle Block Diagram 6.1.1 Main Control Board Using the digital platform of 9G45, the main control board achieves the machine control, display, - 26 -...

  • Page 33: Parameter Board

    Quick TEMP uses measurement sensor to measure oral/axillary/rectal temperature. When measured value is beyond the limit, the monitor will prompt alarm signals; Infrared TEMP uses infrared detection method to measure ear temperature. iM3 is configured with three temperature modules including F3000, T2A and TH.

  • Page 34: Interface

    Vital Signs Monitor Service Manual System Principle 6.2 Interface Figure 6-2 Interface Description Portable handle/Accessory collecting Battery compartment latch Equipotential grounding terminal. AC power input Power cable safety latch. OTG interface/nurse call port USB interface Network interface Battery - 28 -...

  • Page 35: Chapter 7 Troubleshooting

    Vital Signs Monitor Service Manual Troubleshooting Chapter 7 Troubleshooting In transportation, storage and use of monitor, various factors such as unstable network voltage, changing environmental temperature, falling-down or impact, component aging may all result in monitor failures and therefore affect normal application of the device. In failure conditions, professional personnel with the experience of repairing electronic medical devices should perform component-level service for the failure classification listed in the table below.

  • Page 36: Display Failures

    Vital Signs Monitor Service Manual Troubleshooting Shut down suddenly If the monitor is powered by Please connect AC to the battery and shuts down suddenly, monitor charge maybe the battery is too low. battery. The monitor is stricken by Check the power supply and sudden high voltage,...

  • Page 37: Operation Failures

    Vital Signs Monitor Service Manual Troubleshooting 7.3 Operation Failures Phenomenon Possible Cause Solution Buttons are disabled. Button damage or main control Replace the button or main control board damage. board. The edge of the touch screen is Check the assembling of the front pressed.

  • Page 38: Recorder Failures

    Vital Signs Monitor Service Manual Troubleshooting 7.4 Recorder Failures Phenomenon Possible Cause Solution Press Record but no No paper in the drawer. Load paper and close the drawer. paper is out. The drawer is open. Close the drawer. Paper is jammed. Open the drawer and remove the paper.

  • Page 39: Network Failures

    Vital Signs Monitor Service Manual Troubleshooting 7.5 Network Failures Phenomenon Possible Cause Solution ① Malfunction ① Check and repair network linking network linking wire. wire or the HUB. ② Network Bed No. conflict. ② Change Bed No.. Unable to connect to the network.

  • Page 40: Alarm Failures

    Vital Signs Monitor Service Manual Troubleshooting 7.7 Alarm Failures Phenomenon Possible Cause Solution ① Audio alarm is temporarily ① Switch on the audio alarm. disabled. ② Replace the speaker or the wire. No audio alarm is ② Speaker and its connecting activated.
  • Page 41 Vital Signs Monitor Service Manual Troubleshooting ② Parameter board failure. ③ Replace the main control board. ③ Main control board failure. No SpO waveform Sensor or parameter board is Replace the sensor and confirm damaged. the malfunction. ① Patient is moving. ①...

  • Page 42: Chapter 8 Disassembling The Monitor

    Vital Signs Monitor Service Manual Disassembling the Monitor Chapter 8 Disassembling the Monitor WARNING Only qualified service personnel can open the monitor case. Switch off the monitor and disconnect it from the AC mains before disassembling the monitor. (If batteries are used, also take the batteries out from the monitor.) After any repair of the monitor, perform safety tests prior to use.
  • Page 43 Vital Signs Monitor Service Manual Disassembling the Monitor To disassemble the main unit: Disassemble the external plug-in assembly from the main unit with a cross-head screwdriver. Take out the rubber plug with knife, and unscrew the screws securing the rear housing to unfold the rear housing with a cross-head screwdriver.
  • Page 44 Vital Signs Monitor Service Manual Disassembling the Monitor To separate the middle frame and rear housing, unscrew the screws securing middle frame on the bottom and inside the unit with cross head screw driver. - 38 -...
  • Page 45 Vital Signs Monitor Service Manual Disassembling the Monitor - 39 -...

  • Page 46: Disassembling The Front Housing Assembly

    Vital Signs Monitor Service Manual Disassembling the Monitor 8.3 Disassembling the Front Housing Assembly Touch screen or protective screen Main control board Front housing Key board iM3 Front Housing Structure Block Diagram - 40 -...

  • Page 47: Replacing The Touch Screen Or Protective Screen

    ○ ○ ○ ○ ○ ○ ○ ○ ○ Screws Touch screen linking wire iM3 LOGO light board linking ○ ○ Wi-Fi antenna wire ○ ○ iM3 rotary knob board iM3 alarm indicator board ○ ○ iM3 silicone keypad board...

  • Page 48: Replacing The Lcd

    ○ Screws Wi-Fi antenna LCD backlight linking wire ○ ○ Bundling wire interface iM3 Wires linking main control ○ ○ Touch screen linking wire board and FCC rotary knob board ○ ○ iM3 key board linking wire Alarm indicator linking wire...

  • Page 49: Replacing The Main Control Board

    Screws Lithium-manganese button battery iM3 Wires linking main control ○ ○ Micro SD card board and FCC rotary knob board iM3 power linking wire of interface ○ ○ LCD backlight linking wire interface board iM3 Wires linking main control ○...

  • Page 50: Replacing The Wi-Fi Interface Board

    Assemble the Wi-Fi interface board in the reversed order. Connect the wires and fix the main unit. 8.3.5 Replacing the Alarm Indicator Board ○ ○ iM3 alarm indicator FCC iM3 LOGO light board linking ○ ○ linking wire wire - 44 -...

  • Page 51: Replacing The Rotary Knob

    Assemble the alarm indicator board in the reversed order. Connect the wires and fix the main unit. 8.3.6 Replacing the Rotary Knob ○ ○ iM3 Wires linking main control ○ ○ Screws board and FCC interface board Disconnect the wires...

  • Page 52: Replacing Suntech Module

    Vital Signs Monitor Service Manual Disassembling the Monitor iM3 Wires linking parameter ○ ○ Screws board and AC&DC module ○ iM3 AC cable Separate the front Disconnect power Unscrew Replace power and back assembly. module. module linking wire screws securing power module Assemble the power module in the reversed order.

  • Page 53: Disassembling The Middle Frame Assembly

    Vital Signs Monitor Service Manual Disassembling the Monitor 8.5 Disassembling the Middle Frame Assembly Suntech module pump valve assembly 8.5.1 Replacing the Pump/Valve Assembly ○ ○ ○ ○ ○ ○ Screws Valve linking wire ○ ○ Air tube Pump linking wire - 47 -...

  • Page 54: Replacing The Battery Interface Board

    Vital Signs Monitor Service Manual Disassembling the Monitor Separate the front & Remove the wires Remove Remove Pump/Valve back assembly and linking pump and air tube Assembly middle frame valve Cut strap to replace pump Remove screws to replace valve Assemble the pump/valve assembly in the reversed order.

  • Page 55: Replacing The Network Interface Board

    Vital Signs Monitor Service Manual Disassembling the Monitor 8.5.3 Replacing the Network Interface Board ○ ○ Screws Separate the front Take Unscrew network Replace & back assembly network screws of network interface board and middle frame module interface board Assemble the network interface board in the reversed order and fix the main unit. 8.5.4 Replacing Parameter Board ○...
  • Page 56 Vital Signs Monitor Service Manual Disassembling the Monitor ○ ○ ○ ○ ○ iM3 AC cable Pump/valve linking wire iM3 wire linking parameter ○ ○ Screws board and AC&DC module ○ ○ Air tube Snap fastener Separate the front &...

  • Page 57: Replacing Sensor Board Of Main Unit

    Vital Signs Monitor Service Manual Disassembling the Monitor 8.5.5 Replacing Sensor Board of Main Unit ○ ○ ○ ○ iM3 air tap assembly Screws Disassemble Remove the screws Remove the air Replace monitor to get the tap assembly sensor board bottom base Assemble sensor board in the reversed order.

  • Page 58: Disassembling The Plug-In Module

    Push back assembly and code scanning linking wire code scanning middle frame module module outward Assemble QR code scanning module in the reversed order and fix main unit. 8.6 Disassembling the Plug-in Module iM3 Quick TEMP Assembly - 52 -...
  • Page 59 Vital Signs Monitor Service Manual Disassembling the Monitor iM3 Covidien F3000 Quick TEMP Assembly iM3 Infrared ear TEMP Assembly iM3 Recorder Assembly - 53 -...

  • Page 60: Replacing Im3 T2A Isolation Board/T2A Main Control Board

    Vital Signs Monitor Service Manual Disassembling the Monitor 8.6.1 Replacing iM3 T2A Isolation Board/T2A Main Control Board ○ ○ ○ ○ - 54 -...
  • Page 61 & take base outward and plug-in components out top cover remove linking wire module Assemble iM3 isolation board or T2A main control board in the reversed order, and fix the module components. - 55 -...

  • Page 62: Replacing Quick Temp Module/M3 Covidien Temp Module Communication Isolation Board

    Vital Signs Monitor Service Manual Disassembling the Monitor 8.6.2 Replacing Quick TEMP Module/M3 Covidien TEMP Module Communication Isolation Board - 56 -...

  • Page 63: Replacing The Isolation Board Of M3 Infrared Ear Temp

    Vital Signs Monitor Service Manual Disassembling the Monitor ○ ○ ○ Wire linking iM3 parameter ○ ○ Screws board and TEMP module Wire linking Quick TEMP ○ isolation board and F3000 Disassemble Remove screws, Separate the bottom Replace monitor to get the...
  • Page 64 Vital Signs Monitor Service Manual Disassembling the Monitor ○ ○ ○ Wire linking iM3 parameter board ○ ○ Screws and TEMP module Disassemble Remove the screws and Remove screws and Replace monitor to get the prize wires rear cover module...

  • Page 65: Replacing The Recorder

    Vital Signs Monitor Service Manual Disassembling the Monitor 8.6.4 Replacing the Recorder Pull outward softy, and take out the recorder from bottom to top Take the recorder out ○ Screws To get the external Remove Remove wires Replace plug-in assembly as step screws recorder 1 in section 7.1...

  • Page 66: Replacing The Sensor Board Of Recorder

    Vital Signs Monitor Service Manual Disassembling the Monitor 8.6.5 Replacing the Sensor Board of Recorder Remove the water tray outward - 60 -...

  • Page 67: Replacing The Adapter Board Of Recorder

    Vital Signs Monitor Service Manual Disassembling the Monitor Wires linking iM series interface ○ ○ Screws board and recorder To get the external Remove Remove Replace external plug-in assembly as the screws plug-in sensor wires step 1 in section 7.6.3 board Install external plug-in sensor board: Install the sensor board in the reverse order, fix the water tray and fix the external plug-in...

  • Page 68: Chapter 9 Replaceable Parts

    Vital Signs Monitor Service Manual Replaceable Parts Chapter 9 Replaceable Parts WARNING Only connect the replaceable parts supplied by EDAN to the monitor. Parts Part Number iM3 main board PCBA (debugged) 02.03.452351 iM series power module main board PCBA (debugged) 02.03.220400...
  • Page 69 Vital Signs Monitor Service Manual Replaceable Parts Parts Part Number (debugged) iM3 T2A isolation board 02.02.220569 T2A main control board 02.03.114524 M3 Covidien TEMP communication isolation board 02.02.451627 Quick TEMP module 02.03.203123 Lithium battery 02.21.064365 Unicode serial and parallel interface Recorder Assembly 02.01.210633...

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