0% found this document useful (0 votes)
76 views

Edan X12

Uploaded by

Asep Saepuloh
Copyright
© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
0% found this document useful (0 votes)
76 views

Edan X12

Uploaded by

Asep Saepuloh
Copyright
© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 70

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.)


About this Manual
P/N: 01.54.457834
MPN: 01.54.457834011
Release Date: February 2018
© Copyright EDAN INSTRUMENTS, INC. 2017-2018. All rights reserved.

Statement
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.
EDAN owns the copyrights of this manual. Without prior written consent of EDAN, any
materials contained in this manual shall not be photocopied, reproduced or translated into other
languages.
Materials protected by the copyright law, including but not limited to confidential information
such as technical information 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 only considers itself responsible for any effect on safety, reliability and performance of
the equipment if:
Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by
persons authorized by EDAN, and
The electrical installation of the relevant room complies with national standards, and
The instrument is used in accordance with the instructions for use.
EDAN will make available on request circuit diagrams, component part lists, descriptions,
calibration instructions, or other information that will assist service personnel to repair those parts
of the equipment that are designated by EDAN as repairable by service personnel.

I
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.

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

II
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................................................................................................ 8
3.2 Electrical Requirements ..................................................................................................... 8
3.3 Safety Requirements .......................................................................................................... 9
3.4 Installing the Monitor ......................................................................................................... 9
3.5 Connecting to AC Power Supply ..................................................................................... 10
Chapter 4 Test and Maintenance............................................................................................... 11
4.1 Routine Test ..................................................................................................................... 11
4.1.1 Visual Inspection .................................................................................................... 11
4.1.2 Power- on Test ....................................................................................................... 11
4.1.3 Key Test ................................................................................................................. 11
4.1.4 Checking Touch Screen ......................................................................................... 11
4.1.5 Checking Internal Barcode Scanner ....................................................................... 11
4.1.6 Recording Test ....................................................................................................... 12
4.1.7 Alarm Test .............................................................................................................. 12
4.2 Functional Tests and Accuracy Tests ............................................................................... 12
4.2.1 SpO2 Functional Test ............................................................................................. 12
4.2.2 NIBP Functional Test ............................................................................................. 13
4.2.3 NIBP Leakage Test ................................................................................................ 13
4.2.4 NIBP Calibration .................................................................................................... 14
4.2.5 NIBP Accuracy Test .............................................................................................. 15
4.2.6 TEMP Functional Test ........................................................................................... 16
4.3 Safety Test ........................................................................................................................ 17
4.3.1 Safety Test Procedures ........................................................................................... 17
4.3.2 Protective Earth Resistance .................................................................................... 18
4.3.3 Enclosure Leakage Current .................................................................................... 19
4.3.4 Patient Leakage current .......................................................................................... 20
4.3.5 Patient Leakage Current- Single Fault Condition (S.F.C) Mains on Applied Part 21
4.4 Maintenance ..................................................................................................................... 22
4.4.1 Maintenance of the Monitor ................................................................................... 23
4.4.2 Maintenance of the Sensor ..................................................................................... 23
4.4.3 Maintenance of the Battery .................................................................................... 23
4.4.4 Maintenance of the Recorder ................................................................................. 23
Chapter 5 System Configuration ............................................................................................... 24
5.1 Enter Factory Maintain .................................................................................................... 24
5.2 Enter Demo Mode ............................................................................................................ 24
5.3 Default Configuration ...................................................................................................... 25

III
5.4 Network Setup .................................................................................................................. 25
5.5 Configure the System Time ............................................................................................. 25
Chapter 6 Principle Introduction .............................................................................................. 26
6.1 System Principle Block Diagram ..................................................................................... 26
6.1.1 Main Control Board ............................................................................................... 26
6.1.2 Parameter Board ..................................................................................................... 27
6.1.3 Battery Module....................................................................................................... 27
6.2 Interface............................................................................................................................ 28
Chapter 7 Troubleshooting ........................................................................................................ 29
7.1 Machine Failures .............................................................................................................. 29
7.2 Display Failures ............................................................................................................... 30
7.3 Operation Failures ............................................................................................................ 31
7.4 Recorder Failures ............................................................................................................. 32
7.5 Network Failures .............................................................................................................. 33
7.6 Power Board Failures ....................................................................................................... 33
7.7 Alarm Failures .................................................................................................................. 34
7.8 Parameter Failures ............................................................................................................ 34
Chapter 8 Disassembling the Monitor ...................................................................................... 36
8.1 Tools Required ................................................................................................................. 36
8.2 Disassembling the Main Unit ........................................................................................... 36
8.3 Disassembling the Front Housing Assembly ................................................................... 40
8.3.1 Replacing the Touch Screen or Protective Screen ................................................. 41
8.3.2 Replacing the LCD ................................................................................................. 42
8.3.3 Replacing the Main Control Board ........................................................................ 43
8.3.4 Replacing the Wi-Fi Interface Board ..................................................................... 44
8.3.5 Replacing the Alarm Indicator Board .................................................................... 44
8.3.6 Replacing the Rotary Knob .................................................................................... 45
8.4 Disassembling the Rear Housing Assembly .................................................................... 45
8.4.1 Replacing the Power Module ................................................................................. 45
8.4.2 Replacing SunTech Module ................................................................................... 46
8.5 Disassembling the Middle Frame Assembly.................................................................... 47
8.5.1 Replacing the Pump/Valve Assembly.................................................................... 47
8.5.2 Replacing the Battery Interface Board ................................................................... 48
8.5.3 Replacing the Network Interface Board ................................................................. 49
8.5.4 Replacing Parameter Board.................................................................................... 49
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 ..................................... 57
8.6.4 Replacing the Recorder .......................................................................................... 59
8.6.5 Replacing the Sensor Board of Recorder ............................................................... 60
8.6.6 Replacing the Adapter Board of Recorder ............................................................. 61
Chapter 9 Replaceable Parts ...................................................................................................... 62

IV
Vital Signs Monitor Service Manual Warranty and Service

Chapter 1 Warranty and Service


Standard Service
EDAN provides a one-year-warranty for the warranted products (accessories are included). The
warranty period begins on the date the products are shipped to customers. If a customer promptly
notifies EDAN of customer’s warranty claim hereunder, EDAN will either repair, adjust or
replace (with new or exchange replacement parts) EDAN’s products. EDAN warrants that any
service it provides to customers will be performed by trained individuals in a workmanlike
manner.
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.
 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: Model Name, Serial Number (SN) and
Problem Phenomena.
EDAN should not have any obligation to take over the case without this information. The
form can be downloaded at: http://www.edan.com.cn or obtained from EDAN’s Service
Department.
(2) Send EDAN the SCF and Select a Solution.
Once the service department receives the fully filled SCF, EDAN’s engineer will offer a
solution in three working days. EDAN will follow out the case based on the two conditions
below:
Within Warranty:
There are two options:
i) After receiving the Return Material Authorization (RMA) form from EDAN service
department, the customer sends EDAN the defective parts and informs about the shipment
tracking number. Then we will dispatch new part (s) to your confirmed address with
confirmed shipping invoice.

-1-
Vital Signs Monitor Service Manual Warranty and Service

ii) The customer signs the Declaration Form and sends it back by email or fax. This form is
legally certificated to make sure the customer or end-user will return the defective parts to
EDAN on time. We will, at this option, dispatch the replacement one (s) with confirmed
shipping invoice.
NOTE:
1 Both Return Material Authorization Form and Declaration Form are offered by EDAN
service department once the SCF is confirmed by service engineer.
2 The customer is responsible for freight & insurance charges when the equipment is
shipped to 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 and paid, we
will make sure to dispatch good part (s) to the confirmed address.
NOTE: The customer is responsible for any freight & insurance charge for the returned
product.

(3) Obtain the RMA Form.


Before the shipment of the materials, the customer must obtain an RMA form from our
service department, in which the RMA number, description of returning parts and shipping
instructions are included. The RMA number should be indicated on the outside of the
shipping container.
NOTE:
EDAN should not have any obligation to the end-user or customer who returns the goods
without the notification by EDAN’s service department. The sender takes full
responsibility for the accounted fee.

(4) Send the Parts to EDAN.


Follow these recommended instructions:

 Please disassemble the parts with anti-static facility, do not touch the parts with naked hand.
 Please pack the parts safely before return.
 Please put the RMA number on the parcel.
 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.

-2-
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: [email protected]

-3-
Vital Signs Monitor Service Manual Safety Guidance

Chapter 2 Safety Guidance


2.1 Introduction
This service manual is a reference for periodic preventive maintenance and corrective service
procedures for the iM3 monitor. It provides troubleshooting information, assembly procedures,
instructions for functional testing and performance verification. It is intended for use only by
technically qualified service personnel.

WARNING
When performing a service procedure, follow the instructions exactly as presented in this
manual. Failure of doing so might damage the monitor, invalidate the product warranty or
lead to serious personal injury.

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:

Anti-electroshock Type Class I equipment and internal powered equipment


Anti-electroshock Degree SpO2, NIBP, TEMP: BF

Ingress Protection IPX1


With T2A, TH or F3000 TEMP module: Ordinary
equipment (Sealed equipment without liquid proof)

Degree of Safety in Presence of Not suitable for use in presence of flammable gases
Flammable Gases
Working System Continuous operation equipment

2.3 Safety Precautions


To avoid the possibility of injury, observe the following precautions during the operation of the
instrument.

WARNING
1 The monitor must be serviced only by authorized and qualified personnel. EDAN does
not assume any responsibility for damage or injury if modifications or repairs are
carried out by unauthorized personnel.
2 Use and replace the substitutive parts provided or recommended by EDAN only.

-4-
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. It is recommended to perform
the safety test every two years. You are responsible for any requirements specific to
your country.
5 Disconnect the monitor from power before replacing the fuses which are with the
identical specifications.
6 SHOCK HAZARD – Do not remove the top panel cover during operation or while
power is on. The unit cover must be removed only by authorized service personnel.
7 SHOCK HAZARD – Do not attempt to connect or disconnect the power cord with wet
hands. Make sure that 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.Anybody that connects additional equipment to the signal input connector or
signal output connector to configure a medical system must ensure that the system
complies with the requirements of the valid version of the system standard IEC/ EN
6060-1. If you have any question, please consult our technical service department or
your local distributor.
9 Do not directly solder the lead wire and the battery terminal.
10 The safe loads of the wall mounting bracket and the trolley are 7.5 kg and 11 kg
respectively. Exceeding the safe load may cause bracket to fail and the device to fall.

CAUTION
1 The device is designed for continuous operation. Avoid splashing water over the
device.
2 Do not operate the device when it is damp or wet. Avoid using the device immediately
after relocating it from a cold environment to a warm and humid environment. If the
monitor gets damp or liquid pours on the monitor, please contact the service
personnel of EDAN.
3 While the battery is charged, used or stored, keep it away from objects or materials
with static electric charges.

-5-
Vital Signs Monitor Service Manual Safety Guidance

2.4 Explanation of Symbols on the Monitor

1 DEFIBRILLATION-PROOF TYPE BF APPLIED PART

2 TYPE BF APPLIED PART

3 Caution

MR Unsafe - Keep away from magnetic resonance imaging


4 (MRI) equipment

5 Equipotential grounding

6 Power Supply switch

7 SERIAL NUMBER

8 Network port

9 USB (Universal Serial Bus) Connection

10 CE marking

AUTHORISED REPRESENTATIVE IN THE


11 EUROPEAN COMMUNITY

12 Date of manufacture

13 MANUFACTURER

14 Part Number

15 General symbol for recovery/recyclable

-6-
Vital Signs Monitor Service Manual Safety Guidance

16 Disposal method

17 Operating instructions

Refer to User Manual


18 (Background: Blue; Symbol: White)

Warning
19 (Background: Yellow; Symbol & outline: black)

Ingress Protection IPX1 (Protected against vertically


20 falling water drops)

Caution: Federal (U.S.) Law restricts this device to sale by


21 or on the order of a physician.

22 Non-ionizing electromagnetic radiation

23 Output/ Nurse call

24 Chargeable battery

25 Battery check

NOTE:
The service manual is printed in black and white.

-7-
Vital Signs Monitor Service Manual Installation

Chapter 3 Installation
WARNING
Only qualified service engineers shall install this equipment.

3.1 Environment Requirements


Temperature
Working 0 C ~ +40 C (32 ℉~104 ℉)

With TEMP: +10 C ~ +40 C (50 ℉~104 ℉)


Transport and storage -20 C ~ +55 C (-4 ℉~131 ℉)

With TH module: -20 C ~ +50 C (-4 ℉~122 ℉)


Humidity
Working 15% RH ~ 95% RH (non-condensing)
Transport and storage 15% RH ~ 95% RH (non-condensing)
Altitude
Working 86 kPa ~ 106 kPa
Transport and storage 70 kPa ~ 106 kPa

NOTE:
1 If the monitor is installed in a cabinet, allow at least 2 inches (5 cm) clearance around
the monitor for proper air circulation; allow adequate accessibility for servicing, and
adequate room for visualization and operation.
2 Ensure the monitor is not subjected to any source of strong electromagnetic
interference, such as CT, radio transmitters, mobile phones base stations, etc.
3 Do not install the monitor in the presence of flammable anesthetics.
4 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


Operating Voltage 100 V-240 V ~
Operating Frequency 50 Hz/60 Hz
Input Current 0.7 A-0.35 A
Fuse T2.5AH, 250VAC

-8-
Vital Signs Monitor Service Manual Installation

3.3 Safety Requirements

CAUTION
1 SHOCK HAZARD- the power receptacle must be a three-wire grounded outlet. A
hospital grade outlet is required. Never adapt the three-prong plug from the monitor
to fit a two-slot outlet.
2 Do not touch signal input or output connector and the patient simultaneously.
3 Devices connecting with monitor should be equipotential.
4 Do not switch on the monitor until all cables 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.

Figure 3-1 iM3 on a flat surface

-9-
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
1 The wall mounting bracket can be fixed only on a concrete wall.
2 Make sure the monitor is secure on the wall-mounting bracket before releasing your
hands from the monitor.
3 Make sure the mounting bracket for the wall-mounting bracket is well attached to the
monitor before fixing the monitor to the wall-mounting bracket.
4 Check and make sure all screws on the wall-mounting bracket are secure.
5 Make sure the wall-mounting bracket is firmly fixed to the wall.

 To install the monitor on trolley


An Assembling Instruction will be delivered with the Trolley (83.60.261116). Please refer to the
instructions for details of installation.

3.5 Connecting to AC Power Supply


Apply the power cable provided with the monitor. Plug one end of the power cable to the power
socket of the monitor and fasten the connector shoulder with the security lock. Connect the other
end to a grounded 3-phase power output special for hospital use.

NOTE:
Do fasten the connector shoulder with the security lock after plugging the connector into
the socket.

- 10 -
Vital Signs Monitor Service Manual Test and Maintenance

Chapter 4 Test and Maintenance


4.1 Routine Test
An overall check of the monitor, including safety check and functional check, should be
performed by qualified personnel every 24 months or after service.

4.1.1 Visual Inspection


Before using the monitor:
 Inspect the monitor and accessories for obvious signs of damage.
 Check the external cables, power socket and power cable.
Do not use the monitor if any damage is detected until the monitor is repaired by the service
engineers of EDAN or professional service personnel of the dealer.

4.1.2 Power- on Test


Switch on the monitor after it is connected to the power source and check:
 If the power on/off 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 Machine Failures and Display Failures for details.

4.1.3 Key Test


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. Also, the user can confirm the operation by pressing
the trim knob.
If any failure is detected, refer to Section Operation Failures for details.

4.1.4 Checking Touch Screen


When the monitor is configured with a touch screen, touch any available keys on the screen to
check if the screen is working properly.
If any failure is detected, refer to Section Operation Failures for details.

4.1.5 Checking Internal Barcode Scanner


When the monitor is configured with internal barcode scanner, switch on the function and scan
barcode to check if monitor can normally display the contents.

- 11 -
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.
If any failure is detected, refer to Section Recorder Failures for details.
NOTE:
Please make sure paper is well loaded and the setting is correct before printing.

4.1.7 Alarm Test


Trigger a signal that is higher than the upper limit or lower than the lower limit to activate a
physical alarm. Disconnect one of the accessories from the monitor to activate a technical alarm.
Check if the audible and visible alarms work properly.
If any failure is detected, refer to Section Alarm Failures for defective details.

4.2 Functional Tests and Accuracy Tests

WARNING
1 Functional tests and accuracy tests must only be carried out by qualified service
personnel.
2 If function of the monitor is in question, conduct an overall test on the function and
accuracy of the monitor according to the instructions offered by the manufacturer.
3 A functional tester, such as SpO2 simulator and NIBP simulator, can only be used to
assess the parameter consistency and function but not to be used to assess the
clinical measurement accuracy.

A functional check should be performed once possible device malfunction emerges or after
servicing the device.
It is unnecessary to open the device case for functional checks.

4.2.1 SpO2 Functional Test


This test checks the function of the SpO2 measurement. SpO2 simulator is required for this test.
1. Connect the monitor and the SpO2 simulator with a SpO2 cable.
2. Switch on the monitor and the simulator.
3. Set the SpO2 output in the simulator to 70(%).
4. Check for the display on the monitor. A difference within the range of ±2% is reasonable.

- 12 -
Vital Signs Monitor Service Manual Test and Maintenance

4.2.2 NIBP Functional Test


This test checks the function of the NIBP measurement. Tools required for this test are: a NIBP
simulator, a T-fitting, an extension tube and an artificial limb.
1. Connect the NIBP simulator to the monitor.
2. Switch on the monitor and the simulator. Perform calibration prior to using the simulator.
3. Set the patient type both on the monitor and in the simulator to adult; respectively set the
systolic pressure and diastolic pressure (mean pressure) to 255/195(215) mmHg (1
mmHg=0.133 kPa). Start a NIBP measurement.
4. Check for the display on the monitor. A difference within the range of ±8 mmHg is
reasonable.

4.2.3 NIBP Leakage Test


This test checks leakage of the airway and the performance of the NIBP system. See Figure 4-1
for details about tools required.
1. Connect the cuff securely with the socket for NIBP air hole.
2. Wrap the cuff around the cylinder with an appropriate size.
3. Make sure the patient type has been set to Adult.
4. 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. If no system leakage is detected
when the pneumatic system is inflated to 180 mmHg, the system will perform a deflation to an
approximate value of 40 mmHg and subsequently perform the second phase leak test. After 20
seconds to 40 seconds, the system will automatically open the deflating valve and provide
corresponding indication based on the test result.
For SunTech module:
NOTE:
When applying high pressures; take special care to increase the pressure at a rate that
will not cause unwanted overpressure errors (300 mmHg).
Manually inflate the pneumatic system to approximately 250 mmHg. Start the timer and wait 60
seconds for the pneumatic system to reach its pressure equilibrium point. After the waiting period,
record the pneumatic pressure level (P1) and wait another 60 seconds and record the pneumatic
pressure level again (P2). Safety circuitry on the module only allows the pressure in the
pneumatic system to remain above 10mmHg for 180 seconds. When this safety time limit is
exceeded, the valves will open releasing the pressure. Subtract P2 from P1 and this is the leak
rate per minute.
5. If the alarm information NIBP Leak appears, it indicates that the airway may have air leaks.

- 13 -
Vital Signs Monitor Service Manual Test and Maintenance

In this case, the user should check for loose connection. After confirming secure connections,
the user should re-perform the leakage test. If the failure prompt still appears, please contact
the manufacturer for repair.

Figure 4-1 Diagram for NIBP Leakage Test

4.2.4 NIBP Calibration


NOTE:
1 NIBP calibration must be performed by professional personnel authorized by EDAN.
2 NIBP calibration can influence measurement results. Incorrect operation may
influence measurement accuracy.
Tools required:
• T-fitting
• NIBP extension tubes
• Cylinder (200 ml)
• Manometer (Its measurement range should be within the range of 0 to 300 mmHg; its accuracy
should be more precise than the accuracy of ±0.3 mmHg.)
Procedure:
1. Connect the equipment as shown below.

Manometer
Tube
NIBP module
Tube / Patient
Cylinder T-fitting monitor

NIBP
extension
tube or hose
Figure 4-2 Diagram for NIBP Calibration
2. Access Menu > Factory Maintain by inputting the password 998.
3. Select NIBP Calibration from the menu.
4. Select Calibrate Initialization to start calibration.
5. Adjust the manometer value to 50 mmHg (If different values are required for calibration,
keep the value of the manometer consistent with the one displayed on the monitor). After the
value of the manometer stabilizes, select Calibrate Low.
6. Adjust the manometer value to 250 mmHg (If different values are required for calibration,

- 14 -
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. Apply a fixed static pressure on the monitor with the help of the manometer. Check the
displayed values on the monitor against the manometer configuration.
10. A tolerance of ±3 mmHg is reasonable.

4.2.5 NIBP Accuracy Test


This test checks the performance of the NIBP system.
NOTE:
Manometer test is for checking the measurement accuracy and cannot change the
measurement results.
Tools required:
• T-fitting
• NIBP extension tubes
• Cylinder (200 ml)
• Manometer (Its measurement range should be within the range of 0 to 300 mmHg; its accuracy
should be more precise than the accuracy of ±0.3 mmHg.)
Procedure:
1. Access Menu > User Maintain by inputting the password ABC.
2. Connect the equipment as shown below:

Manometer
Tube
NIBP module
Tube / Patient
Cylinder T-fitting monitor

NIBP
extension
tube or hose

Figure 4-3 Diagram for Manometer Test


3. Select NIBP > Manometer.
4. Apply a fixed static pressure on the monitor with the help of the manometer.
5. Wait 10s until the pressure stabilizes. Check the displayed values on the monitor against the
manometer configuration.
6. A tolerance of ±3mmHg is reasonable.

- 15 -
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:
1. Switch on the monitor and the resistance box.
2. Connect the probe with the resistance box.
3. Set the resistance value to (9571Ω) 26 ℃ in the resistance box.
4. Set the resistance value to (6014Ω) 37 ℃ in the resistance box.
5. Set the resistance value to (4542Ω) 44 ℃ in the resistance box.
6. A tolerance of ±0.1 ℃ is reasonable.
For TH TEMP module:
1. Place the thermometer in the calibration mode follow the steps below:
a Press the ON/MEM button to turn the thermometer on. The display of the thermometer
shows symbols and functions.
b Keep pressing the ON/MEM button for five seconds and you will see the “OFF” symbol on
the display. Do not release the button until you see a dot onscreen.
c The thermometer is now in the Calibration Mode and the display is flashing and showing
the “CAL” symbol.
2. Apply a new probe cover.
3. Position the thermometer making the end of the probe against the cavity inside the
thermostatic water bath whose temperature is set to 37 ℃. Press the “Scan” button for 1
second until you hear a long beep sound. The measurement is completed. You can read the
result from LCD.
4. The displayed value should be 37 ℃±0.1 ℃.
For F3000 TEMP module:
1. Remove the isolation chamber/probe from the monitor unit.
2. Install the calibration plug into the visible connector.
3. Switch on the monitor.
4. Insert the probe into the opening in the top of the unit until the tip of the probe reaches the
bottom and three beeps are sounded.
5. The displayed value should be 37 ℃±0.1 ℃

- 16 -
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.
When performing a safety test, you must use a standard safety analyzer such as Fluke 601Pro
Series safety analyzer or equivalent; perform the test according to your local regulations, for
example, in Europe according to IEC/EN60601-1, 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 After the system is installed or set up, safety test must be performed according to IEC
60601-1.
2 Systems must be handled as devices.
3 A system is a combination of several devices of which at least one is a medical
electrical device which is connected to other devices by functional connections or by
a transportable multiple socket outlet.
4 With devices that are connected to other devices by means of a data cable, this
connection must be disconnected prior to performing the electrical safety check, in
order to avoid incorrect measurements.

- 17 -
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.
Allowable value: without mains cable, maximum impendence: 100 mOhm
(IEC 60601-1 and UL60601-1)

- 18 -
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; 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 (UL60601-1)
Single fault condition: 300µA (UL60601-1)

- 19 -
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.
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: 100 µA a.c., 10uA d.c. (BF applied part), 10 µA a.c., 10uA d.c. (CF applied
part)
(IEC/EN60601-1, UL60601-1)
Single fault condition: 500µA a.c., 50uA d.c. (BF applied part), 50µA a.c., 50uAd.c. (CF applied
part)
(IEC/EN60601-1, UL60601-1)

- 20 -
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
CF
DC: <0.01 mA DC: <0.05 mA
Patient Leakage Current
AC: <0.1 mA AC: <0.5 mA
BF
DC: <0.01 mA DC: <0.05 mA

Patient Leakage Current (Mains on CF <0.05 mA


Applied Parts)
BF <5 mA
AC: <0.01 mA AC: <0.05 mA
CF
DC: <0.01 mA DC: <0.05 mA
Patient Auxiliary Current
AC: <0.1 mA AC: <0.5 mA
BF
DC: <0.01 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 testing with other device, you may need to apply the 110% mains voltage manually.

- 21 -
Vital Signs Monitor Service Manual Test and Maintenance

NOTE:
The circuit diagram is based on the Fluke 601Pro series safety Analyzer.
This test measure the current flowing between the applied part and the mains PE in response to an
isolate mains voltage (110% of the mains voltage) applied to applied part. This test is performed
with normal and reverse polarity of the mains voltage using S2, and normal and reverse polarity
of the isolate voltage using S4.
Single fault condition: 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 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.

- 22 -
Vital Signs Monitor Service Manual Test and Maintenance

4.4.1 Maintenance of the Monitor


A stable working environment is recommended. The gathering of dew on the screen may occur
with abrupt temperature or humidity changes.
Keep the exterior surface of the monitor clean, free of dust and dirt. Do not scratch or damage the
screen.

4.4.2 Maintenance of the Sensor


Generally, sensors should be stored in dry environment with the temperature lower than 45 C.
Despite the durability of the sensors, you should use them carefully. Using the sensor with
violence will damage the shell, the piezoelectric crystals and the parts. The shell of the sensor is
made of soft plastic; thus, keep it away from hard or tined objects. Besides, do not over bend the
cable of the sensor.

4.4.3 Maintenance of the Battery


Refer to relevant sections in iM3 Vital Signs Monitor User Manual for details.

4.4.4 Maintenance of the Recorder


The platen, thermal print head and printing paper sensor should be cleaned at least once per year
or whenever needed (e.g. the graph is blurred).
Clean the recorder following the steps below:
1. Clean the platen of the recorder with a piece of soft cloth dipped with suds or water.
2. Clean the thermal array with a piece of cotton swab dipped with 70% isopropyl alcohol.
3. 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.

- 23 -
Vital Signs Monitor Service Manual System Configuration

Chapter 5 System Configuration


The end users cannot change the system configuration of the monitor. As a service engineer, the
users need to change the configuration for them after the monitor is installed and checked
properly.

NOTE:
Restart the monitor after changing the settings.

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 SpO2 module, and to switch the functions
on/off, including recorder, Wi-Fi, encrypt and e-link.
 NIBP Calibration (X2): for NIBP calibration.
 Update (X2) U-disk: for X2 module (NIBP/SpO2) update by U-disk.
 Update (X2) PC: for X2 module (NIBP/SpO2) update through the network connection with
PC.
 LED Test: for physiological/technical alarm indicator test.
 Software Update: for Logo/system software update by U-disk or TFTP server.
 Language Update: for language update by U-disk or TFTP server.
 Wi-Fi Power: to set the power dissipation of Wi-Fi module.
 System: to check device SN and the version information of software & hardware.

5.2 Enter Demo Mode


The monitor works in real-time monitoring mode when monitoring a patient. If you want to show
the traces and parameters for a demonstration, you need 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 will affect patient
monitoring and delay diagnosis and treatment.

- 24 -
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.
 Default: to choose a factory configuration (adult, pediatric or neonate) based on the patient
category, choose a user configuration saved in the monitor if it is available, or check the
configuration currently used. The one labeled with ● is current configuration. If there's no
labeled configuration, it means the currently used configuration is not one of them.
 User Configure: to save the current monitor’s configuration, delete the saved user
configuration or rename it. Three pieces of user configuration can be saved in the monitor.
User can select as desire. The one labeled with ● is current configuration.

5.4 Network Setup


The monitor is provided with two network connection methods: wired network and Wi-Fi. The IP
address in wired network and Wi-Fi can be chosen as static and dynamic, and only if in static, it
can be set up. To set the device IP:
1 Select Menu > User Maintain > input password ABC;
2 Select Network;
3 Set Network Type as Wired or Wi-Fi, access Config;
4 Set Mode as Static, and set the network IP as desired.

5.5 Configure the System Time


1. Select Menu > System Setup > Date/Time.
2. Adjust the date display format based on the user’s habit.
3. Set the correct time of year, month, day, hour, min and sec.
4. Set Display Second to on/off. The current time can display or not display seconds.
5. Set Sync Time to on/off. If network is in good condition, the monitor will or won’t accept
time synchronization from MFM-CMS.
NOTE:
The system time should be reset under following circumstances:
- The monitor is not used for a long period of time.
- The main control board of the monitor is changed.
- The cell on the main control board is changed.

- 25 -
Vital Signs Monitor Service Manual System Principle

Chapter 6 Principle Introduction


6.1 System Principle Block Diagram
The system consists of three parts: main control board, parameter board and power module.

Alarm indicator 8 inch LCD Touch


board screen screen

J3 J10 J4 J5

Rotary knob board J8 Micro-SD


J12
card

Keyboard J9 Main control board

WIFI
J6
module
J7 J14

J37 J25
AC-DC QR code
Reachctrl J19
power J17 module
Power board
TEMP
Interface J31 J8
module
board for Parameter board
network and
USB J30 J28
Pump
SpO2 J12 valve
J29
sensor
board J32
J22 J36 J5
Printer
switching
board Battery,
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 -
Vital Signs Monitor Service Manual System Principle

network, and print functions, with focus on the communication and signal processing functions
between the modules, and the realization of human-computer interaction. The module directly
connected with the main control board includes the button, knob, alarm indicator, 8 inch LCD
screen, touch screen (optional), Micro-SD card, and Wi-Fi (optional), while other modules
communicate with main control board through the parameter transferred board.

6.1.2 Parameter Board


The parameters board is mainly responsible for the power supply management and the
measurement parameters collection; it exports 5V power supply to the main control board, and
simultaneouslycontrolssome module’s power supply. The measured parameters include
noninvasive blood pressure (NIBP), pulse oxygen saturation (SpO2), pulse rate (PR), quick
temperature (Quick TEMP) and infrared temperature (Infrared TEMP). The parameter board
controls these monitoring data and communicates with main board after processing.

NIBP
This monitor uses the oscillometric method for measuring NIBP. It inflates the cuff around the
upper arm, until the cuff pressure blocks the brachial artery blood flow, and then gradually
deflates according to a certain algorithm. With the decrease of cuff pressure, the arterial blood
will bring pressure pulsation in the cuff. Through the pressure sensor connecting with cuff
inflating pipe, a voltage fluctuation signal will be generated with pulse beat.

SpO2& PR
Based on the pleth of finger pulse, etc., SpO2 is calibrated through certain algorithm and clinical
data. SpO2 sensor measures with two built-in luminous diodes and one photocell component. The
two luminous diodes are separately red light and infrared diode, which are light alternately with
certain time order. When hyperemia of the finger capillary occurs repeatedly with the heart pump,
luminous diode light passes through the blood and tissues, and projects onto the photocell.
Photocell can sense the light strength which changes with the pulse blood and whose form is the
changeable optical signals. The ratio of the DC and AC components of the two photoelectric
signals corresponds to the oxygen content in the blood, and the correct oxygen saturation value
can be obtained by a specific algorithm, at the same time, pulse rate can be calculated according
to SpO2 wave.

Quick TEMP& Infrared TEMP


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.

6.1.3 Battery Module


The battery module is mainly responsible for switching AC/DC power. It switches the network
input into +19 V DC power supply to parameter board. The maximum output power is 45W. It
also can charge the battery when parameter board is connected.

- 27 -
Vital Signs Monitor Service Manual System Principle

6.2 Interface

3
6
7
4 8
5
9
Figure 6-2

No Interface Description
1 Portable handle/Accessory collecting
2 Battery compartment latch
3 Equipotential grounding terminal.
4 AC power input
5 Power cable safety latch.
6 OTG interface/nurse call port
7 USB interface
8 Network interface
9 Battery

- 28 -
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.
Component-level service means based on analyzing, replacing or trial-operating the component,
we can pinpoint the failure on a certain component of the device, such as power board, main
control board, TFT assembly, measuring cable or parameter module, etc. Component
maintenance means component-level maintenance, which must be conducted by a service
engineer with abundant experience and with the assistance of special equipment and in specific
environment and conditions. When the monitored parameter has malfunction (such as no
parameters, no waveforms, etc), the service engineer should first check whether the operator's
operation method is appropriate, so as to avoid unnecessary maintenance.

7.1 Machine Failures

Phenomenon Possible Cause Solution

After switching on, LCD ① Fuse damage (If it has fuse ① Replace fuse.
has no display; the power on). ② Replace power board.
indicator is off. ② Power board damage. ③ Anchor the short-circuited
③ Component short-circuits. component.

No display after power-on Main control board failure or Refer to Section 6.2 Display
or black screen during display failure. Failure.
operation, however,
power indicator lights.

Operation or Main control board or Examine the main control


measurement function is corresponding component board and the corresponding
disabled. damage. components.

Accidental crash. ① Instantaneous intensive ① Check power supply and


interference of network. grounding system.
② Poor performance of power ② Replace power board.
board. ③ Replace main control
③ Poor performance of main board.
control board. ④ Replace or repair
④ Bad connection of power connectors.
board or main control board.

- 29 -
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 and charge the
maybe the battery is too low. battery.

The monitor is stricken by Check the power supply and


sudden high voltage, e.g. grounded system.
lightning strike.

Bad connection of power input. Check the power input.

Power failure. Replace the power supply.

Replace the main control


Main control board failure.
board.

7.2 Display Failures

Phenomenon Possible Cause Solution

Characters are displayed Data communication error Replace the main control
normally, however between main control board and board or parameter module
waveforms are displayed parameter module. based on the error prompt.
intermittently.

When powering on the Malfunction in the display Replace the main control
device, power supply is in driver circuit of the main board.
normal operation, however, control board.
there is no display or the
screen turns black during Wire malfunction for LCD Check the connection.
normal operation. backlight power supply. Reconnect the connecting
wire.

Damage of main control board. Replace main control board.

Power board failure. Replace the power board.

Check the connection wire of


Bad connection of LCD display
LCD connection and main
Wrong characters are screen wire
control board.
displayed on screen.
LCD display screen failure. Replace the LCD screen.

- 30 -
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. cover and the touch screen.

Touch screen has no Bad connection of touch screen Check the connection. Reconnect
reaction. wire. the connecting wire.
Touch screen damage. Replace the touch screen.

Main control board failure. Replace the main control board.

Turn the rotary knob, Bad connection of the wire Check the connection. Reconnect
but there’s no between the rotary knob and the connecting wire.
reaction. main control board.
Rotary knob switch damage. Replace the rotary knob.
Main control board failure. Replace the main control board.
Built-in scanner has Bad connection of the wire Check the connection. Reconnect
no emitting light or between the scanner and the connecting wire.
is unable to scan. parameter board.
The malfunction of the scanner Replace the scanner.
leads to the communication
failure with the main control
board.
The malfunction of the main Replace the main control board.
control board leads to the
communication failure with the
scanner.
Insert the USB flash USB flash disk damage. Try another USB flash disk.
disk, and there’s no
reaction. Parameter board failure. Replace the parameter board.

Main control board failure. Replace the main control board.

Hoarse sound or no Malfunction in the audio Replace the main control board.
sound from the subassembly of the main control
speaker. board.

Malfunction in the speaker or Replace the speaker or connecting


connecting wire. wire.

- 31 -
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. Reload paper and close the
drawer.
Recording control board failure. Replace the recording control
board.

Recorder connection failure. Check all the connections.

Gear box/ gear failure. Replace the gear box or the gear.

Main control board failure. Replace the main control board.

The correct printer module Set in Factory Maintain. Turn on


category was not selected. the printer mode. If the printer is
Unicode, select U, otherwise E.

Alarm is displayed The detector of recording paper Clean the detector of recording
onscreen as “out of is contaminated. paper.
paper”, but there is
still paper in the Detector of recording paper Replace the detector of recording
drawer. failure. paper.
The drawer is not fastened up. Fasten up the drawer.
Trace on the Inexact loading of the recording Load the recording paper exactly.
recording paper is paper.
blurred or tilts; or it
is blank on the paper. The two screw nuts on the print Adjust the screw nuts.
head are not adjusted to balance.

Recording head failure. Replace the recording head.

- 32 -
Vital Signs Monitor Service Manual Troubleshooting

7.5 Network Failures

Phenomenon Possible Cause Solution

① Malfunction in network ① Check and repair network linking


linking wire. wire or the HUB.

Unable to connect to ② Network Bed No. conflict. ② Change Bed No..


the network. ③ Main control board failure. ③ Replace the main control board.

The antenna is not connected to Check the connection. Reconnect the


Wi-Fi board. connecting wire.

Unable to connect Wi-Fi board failure. Replace the Wi-Fi board.


Wi-Fi.

Main control board failure. Replace the main control board.

7.6 Power Board Failures

Phenomenon Possible Cause Solution

The fuses are burnt Short circuit of the power or Switch on the monitor for further
when the monitor is other parts. check.
switched on.

The fuses are still Power board failure. Replace the power board.
burnt after
disconnecting all
loads.

Short circuit of the specific Replace the specific part.


The fuses are burnt
part.
when certain part is
connected.

- 33 -
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.
No audio alarm is ② Replace the speaker or the wire.
activated. ② Speaker and its connecting
wire have failure.

The alarm indicator Alarm indicator has failure. Replace the alarm indicator board.
stays off.

No audio alarm or Program failure. Update the software.


visual alarm is
activated.

7.8 Parameter Failures

Phenomenon Possible Cause Solution

NIBP function ① Bad connection between the ① Check the connection


communication stops. parameter board and main between boards.
control board.
② Replace the parameter board.
② NIBP module function of
③ Replace the main control
parameter board has failure.
board.
③ Main control board failure.

NIBP cuff can not be Airway is folded or has leakage. Adjust or repair the airway.
inflated.

Blood pressure can not Cuff becomes loose or patient is Keep the patient quiet; bind the
be measured moving. cuff correctly and safely.
occasionally.

Great error in NIBP ① Cuff size does not fit the ① Use the cuff of appropriate
measurement. patient. size.
② Parameter board failure. ② Replace the parameter board.

SpO2 function ① Bad connection between ① Check the connection


communication stops. parameter board and main between boards.
control board.
② Replace the parameter board.

- 34 -
Vital Signs Monitor Service Manual Troubleshooting

② Parameter board failure. ③ Replace the main control


board.
③ Main control board failure.

No SpO2 waveform Sensor or parameter board is Replace the sensor and confirm
damaged. the malfunction.

SpO2 waveform has ① Patient is moving. ① Keep the patient quiet.


strong interference. ② Environment light is very ② Weaken the light intensity in
intensive. the environment.

SpO2 value is inaccurate Coloring agent has been injected Remove the coloring agent before
into patient body. measurement.

No TEMP value (for ① Bad connection of the wire ① Check the connection.
T2A, F3000 and TH between the TEMP module Reconnect the connecting
module) (T2A, F3000 and TH wire. If the malfunction
module) and the monitor. continues, replace the
connecting wire.
② TEMP module (T2A, F3000
and TH module) is damaged. ② Replace the TEMP module
(T2A, F3000 and TH
③ The TEMP probe is
module).
damaged.
③ Replace the TEMP probe.
④ The main control board is
damaged. ④ Replace the main control
board.

- 35 -
Vital Signs Monitor Service Manual Disassembling the Monitor

Chapter 8 Disassembling the Monitor


WARNING
1 Only qualified service personnel can open the monitor case.
2 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.)
3 After any repair of the monitor, perform safety tests prior to use.

8.1 Tools Required

1 – A cross-head screwdriver

2 – A flat-head screwdriver

3 – A M3 nut driver

4 – A pair of pliers

8.2 Disassembling the Main Unit


The main unit consists of the front housing, rear housing, main frame and other parts

Rear housing
Machine core assembly
Middle frame
Front housing

- 36 -
Vital Signs Monitor Service Manual Disassembling the Monitor

To disassemble the main unit:


1 Disassemble the external plug-in assembly from the main unit with a cross-head screwdriver.

2 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.

3 Unscrew the screws securing the front housing to unfold front housing. Pull out the wires
linking the main board and parameter board to separate the front housing and rear housing.
(When you start to separate the front and rear housing, use your body against the front
housing and then separate them with your hands.)

- 37 -
Vital Signs Monitor Service Manual Disassembling the Monitor

4 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 -
Vital Signs Monitor Service Manual Disassembling the Monitor

- 39 -
Vital Signs Monitor Service Manual Disassembling the Monitor

8.3 Disassembling the Front Housing Assembly

Touch screen or
protective screen Main control board

LCD

Front housing
Key board

iM3 Front Housing Structure Block Diagram

- 40 -
Vital Signs Monitor Service Manual Disassembling the Monitor

8.3.1 Replacing the Touch Screen or Protective Screen


8

7


1 ○
6


5


2


4


3


1 Screws ○
5 Touch screen linking wire
iM3 LOGO light board linking

2 Wi-Fi antenna ○
6
wire

3 iM3 rotary knob board ○
7 iM3 alarm indicator board


4 iM3 silicone keypad board ○
8 iM3 alarm indicator-shade

Separate the Unscrew the screws Disconnect Remove the LCD Remove the
front and back securing the LCD wires supporting bracket touch screen or
assembly supporting bracket assembly and LCD protective screen
and key board

Assemble the touch screen or protective screen in the reversed order. Connect the wires and fix
the main unit.

- 41 -
Vital Signs Monitor Service Manual Disassembling the Monitor

8.3.2 Replacing the LCD


8


1


7


6

2


5


4


3


1 Screws ○
5 Wi-Fi antenna
LCD backlight linking wire

2 Bundling wire ○
6
interface
iM3 Wires linking main control

3
board and FCC rotary knob board ○
7 Touch screen linking wire


4 iM3 key board linking wire ○
8 Alarm indicator linking wire

Separate the front Unscrew the crews securing the Remove the LCD Replace
and back assembly LCD supporting bracket and supporting bracket the LCD
disconnect the linking wire assembly and LCD

Assemble the LCD in the reversed order. Connect the wires and fix the main unit.

- 42 -
Vital Signs Monitor Service Manual Disassembling the Monitor

8.3.3 Replacing the Main Control Board



1


8

2


7


3


4


5 ○
6


1 Screws ○
6 Lithium-manganese button battery
iM3 Wires linking main control

2
board and FCC rotary knob board ○
7 Micro SD card
iM3 power linking wire of interface

3
board ○
8 LCD backlight linking wire interface
iM3 Wires linking main control

4
board and FCC interface board
 Touch screen linking wire


5 iM3 key board linking wire  Alarm indicator linking wire

Separate the front and Disconnect the Remove the screws securing
back assembly related wires. the main control board.

Assemble the main control board in the reversed order. Connect the wires and fix the main unit.

- 43 -
Vital Signs Monitor Service Manual Disassembling the Monitor

8.3.4 Replacing the Wi-Fi Interface Board


2


1


1 Screws ○
2 Wi-Fi antenna

Separate the front and Remove the Wi-Fi Remove the screws securing
back assembly antenna. 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


1 ○
2

iM3 alarm indicator FCC iM3 LOGO light board linking



1
linking wire ○
2
wire

- 44 -
Vital Signs Monitor Service Manual Disassembling the Monitor

Separate the front and Disconnect the wires Untie the snap fastener
back assembly connecting alarm light securing alarm indicator
and LOGO light board. board

Assemble the alarm indicator board in the reversed order. Connect the wires and fix the main unit.

8.3.6 Replacing the Rotary Knob


2


1

iM3 Wires linking main control



1 Screws ○
2
board and FCC interface board
Separate the front Disconnect the wires Remove the Prize up the keypad
and back assembly. connecting the rotary knob cover with a screwdriver
knob and the main with hand
control board.

Assemble the knob in the reversed order. Connect the wires and fix the main unit.

8.4 Disassembling the Rear Housing Assembly


8.4.1 Replacing the Power Module


1


2

3

- 45 -
Vital Signs Monitor Service Manual Disassembling the Monitor

iM3 Wires linking parameter



1 Screws ○
3
board and AC&DC module

2 iM3 AC cable

Separate the front Disconnect power Unscrew the Replace power


and back assembly. module linking wire screws securing module.
power module

Assemble the power module in the reversed order. Connect the wires and fix the main unit.

8.4.2 Replacing SunTech Module


1


2


3

iM3 Wires linking parameter



1 Screws ○
3
board and SunTech module

2 Air tube

Separate the front Remove module Unscrew the screws Replace SunTech
and back assembly wires and air securing SunTech module
tube module

Assemble SunTech module in the reversed order. Connect the wires and air tube, and then fix the
main unit.

- 46 -
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


1


2

3


4


1 Screws ○
3 Valve linking wire


2 Air tube ○
4 Pump linking wire

- 47 -
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. Connect the wires and fix the main
unit.

8.5.2 Replacing the Battery Interface Board


1

2


3

Battery interface board linking



1 Screws ○
3
wire

2 Loudspeaker linking wire

Separate the front Remove battery Unscrew the Replace battery


& back assembly interface board screws of battery interface board
and middle frame linking wire interface board

Assemble the battery interface board in the reversed order. Connect the wires and fix the main unit.

- 48 -
Vital Signs Monitor Service Manual Disassembling the Monitor

8.5.3 Replacing the Network Interface Board


1


1 Screws

Separate the front Unscrew the Take out Replace network


& back assembly screws of network network interface board
and middle frame interface board module

Assemble the network interface board in the reversed order and fix the main unit.

8.5.4 Replacing Parameter Board


3


4


1


2

- 49 -
Vital Signs Monitor Service Manual Disassembling the Monitor


5


5


6


1 iM3 AC cable ○
4 Pump/valve linking wire
iM3 wire linking parameter

2
board and AC&DC module ○
5 Screws


3 Air tube ○
6 Snap fastener

Separate the front & Remove air Remove the screws Replace parameter
back assembly and tube and and remove the snap board
middle frame linking wire fastener outward

Assemble parameter board in the reversed order. Connect the wires, air tube and fix main unit.

- 50 -
Vital Signs Monitor Service Manual Disassembling the Monitor

8.5.5 Replacing Sensor Board of Main Unit


1


2


1 Screws ○
2 iM3 air tap assembly

Disassemble the Remove the screws Remove the air Replace


monitor to get the tap assembly sensor board
bottom base

Assemble sensor board in the reversed order. Install air tap assembly and fix main unit.

8.5.6 Replacing Nellcor Module


1


1 Screws

Disassemble the Remove the screws Replace


monitor to get the Nellcor module
bottom base

Assemble Nellcor module in the reversed order. Install air tap assembly and fix main unit.

- 51 -
Vital Signs Monitor Service Manual Disassembling the Monitor

8.5.7 Replacing QR Code Scanning Module

Separate the front & Remove Push the QR Replace QR


back assembly and linking wire code scanning code scanning
middle frame module outward module

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 -
Vital Signs Monitor Service Manual Disassembling the Monitor

iM3 Covidien F3000 Quick TEMP Assembly

iM3 Infrared ear TEMP Assembly

iM3 Recorder Assembly

- 53 -
Vital Signs Monitor Service Manual Disassembling the Monitor

8.6.1 Replacing iM3 T2A Isolation Board/T2A Main Control Board


4

1


2 ○
3

- 54 -
Vital Signs Monitor Service Manual Disassembling the Monitor


1

Wire linking M50 main board and



1 Screws ○
3
NELL-1 module
Wire linking iM3 parameter Wire linking T2A main board and

2
board and TEMP module

4
interface board

Disassemble the Remove the screws Separate the bottom Replace


monitor to get the and tilt up & take base outward and T2A
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 -
Vital Signs Monitor Service Manual Disassembling the Monitor

8.6.2 Replacing Quick TEMP Module/M3 Covidien TEMP Module


Communication Isolation Board

- 56 -
Vital Signs Monitor Service Manual Disassembling the Monitor


1


2


3

Wire linking iM3 parameter



1 Screws ○
3
board and TEMP module
Wire linking Quick TEMP

2
isolation board and F3000

Disassemble the Remove the screws, Separate the bottom Replace


monitor to get the hold snap fastener and base outward and TEMP
plug-in components pull out the components remove linking wire module

Assemble Quick TEMP Module/M3 Covidien TEMP Module Communication Isolation Board in
the reversed order, and fix the module components.

8.6.3 Replacing the Isolation Board of M3 Infrared Ear TEMP


1

- 57 -
Vital Signs Monitor Service Manual Disassembling the Monitor


2


1


1

Wire linking iM3 parameter board



1 Screws ○
2
and TEMP module

Disassemble the Remove the screws and Remove screws and Replace
monitor to get the prize up rear cover wires module
plug-in components leftward with a screwdriver

Assemble the Isolation Board of M3 Infrared Ear TEMP in the reversed order, and fix the module
components.

- 58 -
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


1 Screws

To get the external Remove the Remove wires Replace


plug-in assembly as step screws recorder
1 in section 7.1

Installing the recorder:


Install the recorder in the reverse order and fix the external plug-in assembly.

- 59 -
Vital Signs Monitor Service Manual Disassembling the Monitor

8.6.5 Replacing the Sensor Board of Recorder

Remove the
water tray
outward

- 60 -
Vital Signs Monitor Service Manual Disassembling the Monitor

Wires linking iM series interface



1 Screws ○
2
board and recorder

To get the external Remove Remove Replace external


plug-in assembly as the screws wires plug-in sensor
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
assembly.

8.6.6 Replacing the Adapter Board of Recorder


1 Screws

To get the internal Remove the Take the Replace the


components of recorder screws clasp apart adapter board
as step 1 in section 7.6.4

Install the adapter board of recorder:


Install the adapter board in the reverse order, fix the water tray and fix the external plug-in
assembly.

- 61 -
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
SunTech Advantage HT TEMP module 01.48.000636
Wi-Fi interface board PCBA (debugged)) 02.03.451683
iM3 battery and Bluetooth interface board PCBA (not
02.02.220524
debugged)
iM3 battery interface board (without Bluetooth) PCBA (not
02.02.220587
debugged)
X2 air valve components 01.58.472153
Lithium-Manganese Button Cell 01.21.064095
Air pump 01.58.472151
iM3 parameter board (EDAN SpO2) PCBA (debugged) 02.03.220513
iM3 parameter board (NELLCOR SpO2) PCBA (debugged) 02.03.220516
iM3 sensor board of main unit (EDAN SpO2) PCBA (not
02.02.220519
debugged)
iM3 sensor board of main unit (NELLCOR SpO2) PCBA (not
02.02.220521
debugged)
SpO2 module 02.08.208106
Speaker 01.14.038040
8-inch LCD screen 01.16.045272
Micro SD card 01.17.052452
iM3 alarm indicator board PCBA 02.02.220577
iM3 Rotary knob PCBA 02.02.452353
iM3 key board 02.48.027329
iM3 Pressure screen components (EDAN, touch screen) 02.01.213973
iM3 Pressure screen components (EDAN, Acrylic) 02.01.213974
iM3 Pressure screen components (Neutral, touch screen) 02.01.213975
iM3 Pressure screen components (Neutral, Acrylic) 02.01.213976
QR code scanning module 01.48.099051
iM3 network and USB interface board PCBA (not debugged) 02.02.220523
M3 Infrared Ear TEMP communication isolation board PCBA 02.03.451308

- 62 -
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
iM3 recorder adapter board 02.02.220531

NOTE:
The part name may vary depending on context, but the part number is constant.

- 63 -

You might also like