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iM80 Patient Monitor Service Manual Test and Maintenance

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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.

Allowable value: without mains cable, maximum impendence: 100 mOhms

(IEC 60601-1 and UL60601-1)

4.3.3 Enclosure Leakage Current

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Содержание iM80

Страница 1: ......

Страница 2: ...and patent information are contained in this manual the user shall not disclose such information to any irrelevant third party The user shall understand that nothing in this manual grants him expressly or implicitly any right or license to use any of the intellectual properties of EDAN EDAN holds the rights to modify update and ultimately explain this manual Responsibility of the Manufacturer EDAN...

Страница 3: ... 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 NOTE A NOTE provides useful information regarding a function or a procedure ...

Страница 4: ... Test 10 4 1 3 Key Test 10 4 1 4 Recording Test 10 4 1 5 Alarm Test 11 4 2 Performance Test 11 4 2 1 ECG Performance Test 11 4 2 2 SpO2 Performance Test 12 4 2 3 NIBP Performance Test 12 4 2 4 NIBP Leakage Test 13 4 2 5 NIBP Calibration 13 4 2 6 TEMP Performance Test 14 4 2 7 CO2 Performance Test 15 4 2 8 IBP Performance Test 15 4 2 9 C O Performance Test 15 4 3 Safety Test 16 4 3 1 Safety Test Pr...

Страница 5: ... Print Controlling Board 26 6 1 5 Power Module 26 6 1 6 Key Board 27 6 1 7 Interface Board big 27 6 1 8 Interface Board small 27 6 1 9 LVDS LCD 27 6 2 Interfaces 28 6 2 1 DB9 Interface 29 6 2 2 RJ45 Interface 29 6 2 3 USB Interface 29 6 2 4 DB15 Interface 29 6 2 5 BNC Interface 29 6 2 6 SD Card Interface 30 6 2 7 Nurse Call Interface 30 Chapter 7 Troubleshooting 31 7 1 Monitor Booting Failures 31 ...

Страница 6: ...2 Replacing the Key Board 41 8 4 3 Replacing the Power Inverter Board 42 8 4 4 Replacing the Knob 42 8 4 5 Replacing the LCD 43 8 4 6 Replacing the Touch Screen 44 8 5 Module Bracket Assembly 44 8 5 1 Replacing the Main Board 44 8 5 2 Replacing the IBP C O Module 46 8 5 3 Replacing the SpO2 Module 46 8 5 4 Replacing the CO2 Module 46 8 5 5 Replacing NIBP Module 47 8 5 6 Replacing the ECG Module 48...

Страница 7: ... responsible may void the warranty Groupware is dismounted stretched or redebugged Unauthorized modification or misuse Damage caused by operating beyond the environmental specifications for the medical product Change or remove original serial number label or Manufacturer symbol Improper use Service Procedure 1 Fill in the Service Claim Form SCF Fill in the SCF with detailed information including M...

Страница 8: ...EDAN for service including custom charges EDAN is responsible for the freight insurance custom charges from EDAN to the customer Out of Warranty 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 a...

Страница 9: ...l Please describe the returned parts as sample of and put the total value on the invoice and note on the invoice as sample no commercial value Please confirm the invoice with EDAN before shipment Please send back the parts after EDAN s confirmation Contact Information If you have any question about maintenance technical specifications or malfunctions of devices do not hesitate to contact us EDAN I...

Страница 10: ...ght result in damage to the monitor or personal injury 2 2 General Information iM80 Patient 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 Anti electroshock Type Class I equipment and internal powered equipment Anti electroshock Degr...

Страница 11: ... your hands are clean and dry before touching the power cord 8 Accessory equipment connected to the analog and digital interface must be certified according to the respective IEC EN standards e g IEC EN 60950 for data processing equipment and IEC EN 60601 1 for medical equipment Furthermore all configurations shall comply with the valid version of the system standard IEC EN 60601 1 1 Anybody who c...

Страница 12: ...iM80 Patient Monitor Service Manual Safety Guidance 6 3 While the battery is charged used or stored keep it away from objects or materials with static electric charges ...

Страница 13: ...ssure 860hPa 1060hPa Storage Temperature 20 ºC 55 ºC Relative Humidity 25 93 non condensing Atmospheric Pressure 700hPa 1060hPa NOTE 1 Do not install the monitor in close proximity to flammable anesthetics 2 Keep the environment clean and keep the device away from corrosive medicine Prevent the device from vibration high temperature humidity and exposure to the sun 3 2 Electrical Requirements Oper...

Страница 14: ...t connected to the monitor should be equipotential to ensure effective grounding 4 Do not switch on the monitor until all units and accessories have been properly connected and verified 3 4 Installing the Monitor 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 iM80 on a Flat Surface To in...

Страница 15: ...C Power Apply the power cable offered with the monitor Plug one end of the power cable to the power socket of the monitor before buckling the security lock to the plug as showed below Then connect the other end to a grounded 3 prong power output special for hospital usage ...

Страница 16: ... indicator lights up If the alarm indicators flicker and if the alarm tone is heard If some images and characters are missing If there are bright spots and dark shadows on the LCD screen If the waveforms fonts and symbols displayed on the LCD screen are normal If any failure is detected refer to section Monitor Booting Failures and Display Failures for details 4 1 3 Key Test Press the keys on the ...

Страница 17: ...Performance test must only be carried out by qualified service personnel 2 If performance of the monitor is in question conduct an overall performance test according to the instructions offered by the manufacturer A performance check should be performed once possible device malfunction emerges or after servicing the device It is unnecessary to open the device case for performance checks 4 2 1 ECG ...

Страница 18: ...lue should be 70 2 4 2 3 NIBP Performance Test This test checks the performance of the NIBP measurement Tools required NIBP simulator T fitting Extension tube Artificial limb Procedure 1 Connect the NIBP simulator to the monitor 2 Switch on the monitor and the simulator Calibrate the simulator before using it 3 Set the patient type on the monitor to adult set the simulator to the following configu...

Страница 19: ... a pneumatic measurement If the prompt of Leak Test OK appears it indicates that the airway is in good situation and no air leaks exist However if the alarm information of NIBP Cuff Leak appears it indicates that the airway may have air leaks In this case the user should check for loose connection After confirming secure connections the user should re perform the pneumatic test If the failure prom...

Страница 20: ...r with the help of the manometer Compare the displayed values on the monitor with the manometer values 5 A difference within the range of 3mmHg is reasonable 4 2 6 TEMP Performance Test This test checks the performance of the TEMP measurement Tools required resistance box Procedure 1 Switch on the monitor and the resistance box 2 Set the probe type on the monitor to YSI 10K and respectively connec...

Страница 21: ...simulator Procedure 1 Connect the IBP cable to the connector for channel BP2 on the patient simulator and to the IBP connector on the monitor 2 Set the simulator to 0 pressure and perform a zero calibration 3 After completing the zero calibration configure the simulator as P static 200mmHg 4 Perform a dynamic pressure test Set the simulator to the following configuration RADIALART 120 80 The toler...

Страница 22: ... example in Europe according to IEC EN60601 1 IEC EN60601 1 1 in USA according to UL60601 1 For the test setup please refer to the Instructions for Use of the test equipment used Additional test may be required by your local regulations You are recommended to document the result of the safety test NOTE 1 When testing according to IEC 60601 1 system must be tested and not individual devices 2 Syste...

Страница 23: ...res 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 Allowable value without mains cable maximum impendence 100 mOhms IEC 60601 1 and UL60601 1 4 3 3 Enclosure Leakage Current ...

Страница 24: ...thin the patient environment normal and reversed polarity using S2 test performed both in normal condition and single fault conditions Normal condition NC with S1 S3 S5 closed S2 S4 variable Single fault condition SFC S1 S3 open one for each time and S5 closed S2 S4 variable Allowable value Normal condition 100µA IEC EN60601 1 Single fault condition 500µA IEC EN60601 1 Normal condition 100µA UL606...

Страница 25: ...mal condition and single fault condition Normal condition NC with S1 S3 S5 closed S2 S4 variable Single fault condition SFC S1 S3 open one for each time and S5 closed S2 S4 variable Allowable value Normal condition 10µA BF applied part 10µA CF applied part IEC EN60601 1 UL60601 1 Single fault condition 500µA BF applied part 50µA CF applied part IEC EN60601 1 UL60601 1 Leakage Current Applied Part ...

Страница 26: ...F 0 05 mA BF 5 mA Patient Auxiliary Current CF AC 0 01 mA DC 0 01 mA AC 0 05 mA DC 0 05 mA BF AC 0 1 mA DC 0 01 mA AC 0 5 mA DC 0 05 mA 4 3 5 Patient Leakage Current Single Fault Condition S F C Mains on Applied Part NOTE The following test is based on test with the Fluke 601 pro series safety analyzer This device allows applying a 110 mains voltage between the applied part and the device PE When ...

Страница 27: ...ion S1 S3 S5 closed S2 S4 S6 variable Allowable value Single fault condition 110 mains voltage on applied part 5000µA BF applied part 50µA CF applied part IEC EN 60601 1 UL 60601 1 4 4 Maintenance For details about basic cleaning and maintenance methods refer to relevant sections in Patient Monitor User Manual For further technical support contact service engineers of EDAN Users are responsible fo...

Страница 28: ...ed to enter the Demo mode 1 Select Menu Common Function 2 Select Demo Mode and input the password 3045 by using the soft keyboard 3 Select OK to enter the Demo mode WARNING Demonstration function is for performance demonstrating and training usage It is forbidden in clinical applications in case medical staff mistake what displays on the monitor as the waveforms and parameters of the patient which...

Страница 29: ...tain Bed No 3 Select a device No from 1 to 254 and press the knob to confirm it CAUTION Make sure the device No of the monitors in the same system do not overlap 5 5 Changing Network Bed No This network bed No is the physical device No of the monitor in the network and used for setting the IP address of the device It needs to be set if the device connects to the CMS network ...

Страница 30: ... boards Here is the system principle block diagram Figure 6 1 iM80 System Principle Block Diagram 6 1 1 Main Board The main board applied in iM80 monitor is 9G45 main board developed by EDAN The operating system is embedded As the core of the system the main control board fulfills the following functions key input control LCD display recording audio alarm and led indicator light alarm data memory ...

Страница 31: ...erface 1 interface USB 2 standard USB HOST interfaces 1 standard DEVICE interface 2 0 specification VGA 1 VGA output port standard VGA outputting LCD 1 TFT LCD interface 1024 768 highest resolution Keyboard 1 PS 2 keyboard interface GPIO 10 Watchdog Timer 1 6s Power Consumption 5 934 W max 1 775W typical Size 134 mm 107 mm Operating System Linux 6 1 2 ECG Module The ECG module fulfills the functio...

Страница 32: ... Figure 6 2 Print controlling board principle block diagram The iM80 printer module includes microprocessor circuit power switch and control communication interface motor control part recorder paper detecting circuit time control for printing power and heating paper lacking temperature control and thermo sensitive head protecting circuit 6 1 5 Power Module The power module is EDAN PS900Q It output...

Страница 33: ... Touch screen Key board Main board Knob Alarm light Inverter Figure 6 3 Key Board Principle Block Diagram 6 1 7 Interface Board big Interface board includes SD card interface analog output synchronous defibrillation interface nurse call interface RS232 interface VGA visual signal interface audio interface power control board interface printer interface and the second network interface 6 1 8 Interf...

Страница 34: ...mA cd m2 250 Typ center Contrast Ratio 500 1 Typ Nominal Input Voltage VDD Volt 3 3 Typ Typical Power Consumption VDD line VCFL line Watt 8 6 Typ Weight Grams 1200 Physical Size mm 326 5 W x 253 5 H x 11 4 D Electrical Interface LVDS Support Color Native 16 196 227 colors RGB 6 bit driver Temperature Range Operating Storage Shipping C C 0 to 50 20 to 60 6 2 Interfaces Figure 6 4 Interface Diagram ...

Страница 35: ... 6 2 2 RJ45 Interface All monitors are configured with an RJ45 interface It is used to connect the monitor to a computer for updating or monitoring information collection or to a monitoring system such as MFM CMS 6 2 3 USB Interface All monitors are configured with a USB interface It is used to connect external devices that support USB protocol to the monitor 6 2 4 DB15 Interface All monitors are ...

Страница 36: ... 6 SD Card Interface All monitors are configured with an SD interface It is used to store the data of the monitor in external SD card 6 2 7 Nurse Call Interface All monitors are configured with a nurse call interface It is used to carry out the function of nurse call ...

Страница 37: ... board defective Check whether the keys sound properly If yes examine the LCD LCD defective If the keys don t sound it may be the fault of the main control board Replace the main control board Characters display correctly but waveforms display intermittently Faulty data communication between main control board and parameter module Replace the main control board link board or parameter module to ve...

Страница 38: ...Check that the cables between the key board and the touch screen are well connected The touch screen is damaged Replace the touch screen The touch position invalid The touch screen is not calibrated Calibrate the touch screen using procedures described in section To Calibrate Touch Screen of the user manual 7 4 Operation Failures Phenomenon Possible Cause Solution Keys or rotary coder not function...

Страница 39: ...in control board defective Replace main control board 7 7 Alarm Failures Phenomenon Possible Cause Solution No audible alarm is activated The audible alarm is temporarily disabled Switch on the audible alarm Loudspeaker or wire defective Replace the loudspeaker or the wire The alarm indicator stays off Alarm indicator defective Replace alarm indicator Alarm indicator board defective Replace alarm ...

Страница 40: ...y Insert the U disk once again or replace it 7 10 ECG Monitoring Failures Phenomenon Possible Cause Solution No ECG trace Bad connection of electrodes Use new electrodes and ensure good connection ECG waveform is disabled Enable ECG waveform in system menu See the user manual RL electrode hangs in the air Connect RL electrode well No CAL self test Replace the module ECG module defective Replace th...

Страница 41: ...g SpO2 waveform interference Patient activity Quiet the patient Extremely strong ambient light Weaken ambient light SpO2 value is inaccurate The patient is injected with dye Eliminate dye before measurement 7 12 NIBP Monitoring Failures Phenomenon Possible Cause Solution The cuff fails to be inflated The cuff is folded or air leak occurs Repair the cuff No NIBP numeric value Loose cuff or patient ...

Страница 42: ... Measurement Tube jam displays on the interface in CO2 measurement CO2 sampling tube has a jam Unplug the sampling tube and clear foreign matters and then connect it again Or replace the sampling tube CO2 waveform is normal but data measurement has an error CO2 module has not been zeroed for a long time thus the measurement is inaccurate Open CO2 setup menu and zero CO2 The settings of compensatio...

Страница 43: ...GAS module GAS module defective Replace GAS module AG waveform is smooth GAS module is in Standby mode Change Standby mode to Measurement mode The tube is jammed or not connected well Power off and clean or replace the tube The module is zeroed automatically Normal phenomenon AG measurement numeric value has an error GAS module has not been zeroed for a long time thus the measurement is inaccurate...

Страница 44: ...re disassembling the monitor 3 After any repair of the device perform safety tests prior to use 8 1 Tools Required 8 2 Replacing Fuses To replace the melted fuses 1 Switch off the monitor and disconnect it from power 2 The back of the monitor should face the operator 3 Pull out the fuse box and pick the inside fuse up with a flat head screwdriver 1 A cross head screwdriver 2 A flat head screwdrive...

Страница 45: ...ling the Main Unit The main unit consists of the front housing back housing main frame CO2 assembly TEMP assembly and recorder Figure 8 1 Main Unit Structure Block Diagram To disassemble the main unit 1 Place the monitor on the protective pad on a flat surface 2 Unscrew the screws securing the front and back housings and the front and back assemblies are unfolded Front housing Module bracket assem...

Страница 46: ...he front housing and back housing assemblies shown in circle in the figure below 4 Place the back assembly on a flat surface and unscrew the screws securing the module bracket assembly and disconnect the wires to separate the module bracket assembly 5 Unscrew the screws securing the main frame on the bottom and inside the unit and the main frame are separated from the back assembly Screws M3X12 ...

Страница 47: ...ble the alarm indicator board in the reverse order 8 4 2 Replacing the Key Board 1 Wire connecting knob board 2 Wire connecting main board 3 Wire connecting inverter board 4 Wire connecting touch screen 5 Screw Unscrew the screws securing alarm indicator board Disconnect wire to alarm indicator board Separate the front and back assembly Alarm indicator board Key board Inverter board LCD Knob board...

Страница 48: ...er 8 4 4 Replacing the Knob To disassemble the knob Assemble the knob in the reverse order Separate the front and back assemblies Loosen nut securing the knob cap by using pliers Remove the knob cap by using pliers Unscrew the screws on power inverter board Disconnect all wires on power inverter board Separate the front and back assembly Disconnect all wires on key board Separate the front and bac...

Страница 49: ...ling the Monitor 43 8 4 5 Replacing the LCD To disassemble LCD Assemble LCD in the reverse order Separate the front and back assemblies Unscrew the screws on LCD Disconnect wires on LCD Unscrew the screws on display assembly stander Screws Screws ...

Страница 50: ...e reverse order 8 5 Module Bracket Assembly 8 5 1 Replacing the Main Board To disassemble main board Separate the front and back assemblies Unscrew the screws on touch screen Disconnect wires on touch screen Remove LCD assembly and replace touch screen Touch screen SpO2 module CO2 module Main board NIBP module ECG module Wires to be disconnected Screws ...

Страница 51: ...dule 3 Wire connecting CO2 module 4 Wire connecting power module 5 Wire connecting key board 6 Wire connecting interface board big 7 Wire connecting interface board small 8 Wire connecting NIBP module 9 Wire connecting interface board big Separate the front and back assemblies Unscrew the screws securing main board Disconnect wires on main board 4 5 3 2 1 6 7 8 9 ...

Страница 52: ...ies as described in section 8 3 Unscrew the screws securing IBP module Disconnect wires connecting IBP module Separate the front and back assemblies Unscrew the screws securing SpO2 module Disconnect wires connecting SpO2 module Wire connecting SpO2 module Wire connecting main board Wire connecting CO2 module Wire connecting main board Wire connecting C O module Wire connecting main board Wire con...

Страница 53: ... module Assemble the NIBP module in the reverse order Separate module bracket assembly as described in section 8 3 Unscrew the screws securing NIBP module Disconnect wires connecting NIBP module Separate the front and back assemblies Unscrew the screws securing CO2 module Disconnect wires connecting CO2 module Wire connecting main board Wire connecting main board Wire connecting main board ...

Страница 54: ...8 8 5 6 Replacing the ECG Module 8 6 Main Bracket Assembly 8 6 1 Replacing the Recorder To disassemble the recorder Wire connecting main board Wire connecting TEMP module Wire connecting ECG module Speaker Interface board big Fan Interface board small Power module ...

Страница 55: ...r Module Separate main bracket assembly as described in section 8 3 Unscrew the screws securing speaker assembly Disconnect wires connecting speaker Unscrew the screws securing speaker Open the paper casing Disconnect wires connecting recorder Unscrew the two screws Wire connecting speaker Wire connecting interface board big Wire connecting power module Wire connecting main board Wire connecting f...

Страница 56: ...g the Power Interface Board To disassemble the power interface board Separate main bracket assembly as described in section 8 3 Unscrew the screws and nuts securing fan assembly Unscrew the screws securing fan assembly and disconnect wires connecting it Separate main bracket assembly as described in section 8 3 Unscrew the screws securing power module Disconnect wires connecting power module Wire ...

Страница 57: ...g Separate main bracket assembly as described in section 8 3 Disconnect wires connecting interface board big Unscrew the screw securing back board Unscrew the screws and nuts securing power interface board big Separate main bracket assembly as described in section 8 3 Disconnect wires connecting power interface board and unscrew the screws Unscrew the screws and nuts securing power interface board...

Страница 58: ... Screen 01 16 078211 Alarm Indicator Board 02 02 113653 Interface Board big 02 03 113609 11 Interface Board small 02 02 113607 iM80 Key Board 12 03 220070 Power Module Assembly 02 01 210066 Inverter 02 08 113741 Main Board 12 03 451109 10 X2 Module 22 01 210444 M80 CO2 Isolation Power Plug Board 12 02 101058 11 E8 Module 02 01 109095 E6 Module 12 03 451487 Recorder 22 01 210443 Knob Board 12 02 16...

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