EDAN iSe Series User manual

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文件名称(Document Name)：iSE系列多道心电图机维修手册-英文
文件编号(Number)：01.54.458572
版本(Version)：1.0
产品型号(Product Model)：iSE-1015;iSE-1016;iSE-1018;iSE-1019;iSE-
1210;iSE-1615;iSE-1616;iSE-1618;iSE-1619;iSE-1810;iSE
项目编码(Project Code)：00011C001
签批信息(Signature):
作者(Originator) : 严 慧敏 (yanhuimin) 2020-04-30 15:47:28
审核人(Reviewers) : 兰 小燕 (lanxiaoyan) 2020-04-30 16:16:29
审核人(Reviewers) : 杨 洁 (yangjie) 2020-04-30 15:51:16
审核人(Reviewers) : 宋 晓菁 (songxiaojing) 2020-05-06 10:54:08
审核人(Reviewers) : 聂 宪忠 (niexianzhong) 2020-04-30 15:50:50
审核人(Reviewers) : 聂 宪忠 (niexianzhong) 2020-04-30 15:50:50
审核人(Reviewers) : 陈 浩杰 (chenhaojie) 2020-04-30 16:41:37
审核人(Reviewers) : 马 巍 (mawei) 2020-04-30 16:14:31
审核人(Reviewers) : 焦 欣 (jiaoxin) 2020-04-30 17:46:27
审核人(Reviewers) : 聂 宪忠 (niexianzhong) 2020-04-30 15:50:50
审核人(Reviewers) : 严 彬彬 (yanbinbin) 2020-04-30 16:40:01
审核人(Reviewers) : 肖 文聪 (xiaowencong) 2020-04-30 16:14:27
审核人(Reviewers) : 黄 永开 (huangyongkai) 2020-04-30 17:16:59
审核人(Reviewers) : 汪 金平 (wangjinping) 2020-05-04 10:42:15
审核人(Reviewers) : 明 镭 (minglei) 2020-04-30 16:47:32
审核人(Reviewers) : 张 在阳 (zhangzaiyang) 2020-05-04 09:46:40
批准人(Approvers) : 肖 文聪 (xiaowencong) 2020-05-06 11:49:02

版权©深圳市理邦精密仪器股份有限公司 (Copyright©Edan Instrument,Inc.)

I
About this Manual
P/N: 01.54.458572
MPN: 01.54. 458572010
Release Date: April 2020
© Copyright EDAN INSTRUMENTS, INC. 2020. 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) cannot 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.

II
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.

III
Table of Contents
Chapter 1 Warranty and Service..............................................................................................1
Chapter 2 Safety Guidance .......................................................................................................4
2.1 Warnings and Cautions....................................................................................................4
2.1.1 Safety Warnings ....................................................................................................4
2.1.2 Li-ion Battery Care Warnings ...............................................................................8
2.1.3 General Cautions...................................................................................................9
2.2 List of Symbols...............................................................................................................9
Chapter 3 Overview.................................................................................................................12
3.1 Technical Specifications................................................................................................12
3.1.1 Safety Standards..................................................................................................12
3.1.2 Classifications.....................................................................................................12
3.1.3 Environment Requirements.................................................................................13
3.1.4 Power Supply Specifications...............................................................................13
3.2 System Architecture and Connection............................................................................14
3.2.1 System Architecture............................................................................................14
3.2.2 Upper Casing.......................................................................................................15
3.2.3 Printer..................................................................................................................16
3.2.4 Main Board .........................................................................................................17
3.2.5 DE12 ECG Board................................................................................................18
3.2.6 DE18 ECG Board................................................................................................19
Chapter 4 Optional and Advanced Functions .......................................................................21
4.1 Configuring a Barcode Reader......................................................................................21
4.2 Using USB Storage Devices .........................................................................................22
Chapter 5 Inspection and Troubleshooting............................................................................23
5.1 Appearance Inspection ..................................................................................................23
5.2 Power-On Test...............................................................................................................23
5.3 Checking Battery Charging...........................................................................................23
5.4 Checking Network ........................................................................................................24
5.5 Checking Output Interface............................................................................................24
5.6 Testing DE12 ECG Board.............................................................................................24
5.7 Testing the Main Board of DE18 Sampling Box ..........................................................25
5.8 Troubleshooting ............................................................................................................26
Chapter 6 Electrocardiograph Disassembly..........................................................................32
6.1 Tools Required ..............................................................................................................32
6.2 Disassembling the Lower Casing..................................................................................32
6.3 Disassembling the Printer .............................................................................................34

IV
6.4 Disassembling the Printer Head....................................................................................35
6.5 Disassembling DE18 Sampling Box.............................................................................36
Chapter 7 Renewable Parts.....................................................................................................38

iSE Series Electrocardiograph Service Manual Warranty and Service
- 1 -
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 re-debugged.
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 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

iSE Series Electrocardiograph Service Manual Warranty and Service
- 2 -
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.
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.

iSE Series Electrocardiograph Service Manual Warranty and Service
- 3 -
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.
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: [phone]
FAX: [phone]
E-mail: [email protected]

iSE Series Electrocardiograph Service Manual Safety Guidance
- 4 -
Chapter 2 Safety Guidance
This chapter provides important safety information on the use of iSE electrocardiographs.
2.1 Warnings and Cautions
To use the system safely and effectively, firstly be familiar with the operation method of
Windows and read the user manual in detail to be familiar with the proper operation method for
the purpose of avoiding the possibility of system failure. The following warnings and cautions
must be paid more attention to during the operation of the system.
2.1.1 Safety Warnings
WARNING
1. The electrocardiograph is intended to be used by qualified physicians or personnel
professionally trained. They should be familiar with the contents of this user manual
before operation.
2. Only qualified service engineers can install this equipment, and only service
engineers authorized by the manufacturer can open the shell. Otherwise, safety
hazards may happen.
3. EXPLOSION HAZARD - Do not use the electrocardiograph in the presence of
flammable anesthetic mixtures with oxygen or other flammable agents.
4. SHOCK HAZARD - The power receptacle must be a hospital grade grounded outlet.
Never try to adapt the three-prong plug to fit a two-slot outlet.
5. Make sure that the power is turned off and the power cord is disconnected from the
AC socket before connecting or disconnecting equipment. Otherwise, electrical
shock or other injuries may happen to the patient or operator.
6. If the integrity of the external protective conductor is in doubt, the equipment should
be powered by an internal li-ion rechargeable battery.
7. Do not use this equipment in the presence of high static electricity or high voltage
equipment which may generate sparks.

iSE Series Electrocardiograph Service Manual Safety Guidance
- 5 -
WARNING
8. Only the patient cable and other accessories supplied by the manufacturer can be
used. Or else, the performance and electric shock protection cannot be guaranteed.
9. The use of patient cable and other accessories not supplied by the manufacturer may
result in increased emissions or decreased immunity of the equipment.
10. The electrocardiograph has been safety tasted with the recommended accessories,
peripherals, and leads, and no hazard is found when the electrocardiograph is
operated with cardiac pacemakers or other stimulators.
11. Make sure that all electrodes are connected to the patient correctly before operation.
12. Ensure that the conductive parts of electrodes and associated connectors, including
neutral electrodes, do not come in contact with earth or any other conducting objects.
13. Disposable electrodes must be used during defibrillation.
14. Electrodes of dissimilar metals should not be used; otherwise it may cause a high
polarization voltage.
15. The disposable electrodes can only be used for one time.
16. Do not touch the patient, bed, table or the equipment while using the ECG together
with a defibrillator.
17. Do not touch accessible parts of electrical equipment and the patient simultaneously.
18. The use of equipment that applies high frequency voltages to the patient (including
electrosurgical equipment and some respiration transducers) is not supported and
may produce undesired results. Disconnect the patient data cable from the
electrocardiograph, or detach the leads from the patient prior to performing any
procedure that uses high frequency surgical equipment.
19. Fix attention on the examination to avoid missing important ECG waves.
20. SHOCK HAZARD - Don't connect non-medical electrical equipment, which has been
supplied as a part of the system, directly to the wall outlet when the non-medical
equipment is intended to be supplied by a multiple portable socket-outlet with an
isolation transformer.
21. SHOCK HAZARD - Don't connect electrical equipment, which has not been supplied
as a part of the system, to the multiple portable socket-outlet supplying the system.

iSE Series Electrocardiograph Service Manual Safety Guidance
- 6 -
WARNING
22. Do not connect any equipment or accessories that are not approved by the
manufacturer or that are not IEC/EN 60601-1 approved to the electrocardiograph.
The operation or use of non-approved equipment or accessories with the
electrocardiograph is not tested or supported, and electrocardiograph operation and
safety are not guaranteed.
23. Any non-medical equipment (such as the external printer) is not allowed to be used
within the patient vicinity (1.5m/6ft.).
24. Do not exceed the maximum permitted load when using the multiple portable
socket-outlet(s) to supply the system.
25. Multiple portable socket-outlets shall not be placed on the floor.
26. Do not use the additional multiple portable socket-outlet or extension cord in the
medical electrical system, unless it's specified as part of the system by manufacturer.
And the multiple portable socket-outlets provided with the system shall only be used
for supplying power to equipment which is intended to form part of the system.
27. Accessory equipment connected to the analog and digital interfaces 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 standard IEC/EN 60601-1.
Therefore anybody, who connects additional equipment to the signal input or output
connector to configure a medical system, must make sure that it complies with the
requirements of the valid version of the system standard IEC/EN 60601-1. If in doubt,
consult our technical service department or your local distributor.

iSE Series Electrocardiograph Service Manual Safety Guidance
- 7 -
WARNING
28. Connecting any accessory (such as external printer) or other device (such as the
computer) to this electrocardiograph makes a medical system. In that case,
additional safety measures should be taken during installation of the system, and the
system shall provide:
a) Within the patient environment, a level of safety comparable to that provided by
medical electrical equipment complying with IEC/EN 60601-1, and
b) Outside the patient environment, the level of safety appropriate for non-medical
electrical equipment complying with other IEC or ISO safety standards.
29. All the accessories connected to system must be installed outside the patient vicinity,
if they do not meet the requirement of IEC/EN 60601-1.
30. If multiple instruments are connected to a patient, the sum of the leakage currents
may exceed the limits given in the IEC/EN 60601-1 and may pose a safety hazard.
Consult your service personnel.
31. The electrocardiograph shall not be serviced or maintained while in use with a
patient.
32. The appliance coupler or mains plug is used as isolation means from supply mains.
Position the electrocardiograph in a location where the operator can easily access
the disconnection device.
33. The medical electrical equipment needs to be installed and put into service according
to Appendix 2 EMC information in the User Manual.
34. The equipment should not be used adjacent to or stacked with other equipment, refer
to the recommended separation distances provided in Appendix 2 EMC Information
in the User Manual.
35. Portable and mobile RF communications equipment can affect medical electrical
equipment, refer to the recommended separation distances provided in Appendix 2
EMC Information in the User Manual.
36. Assembly of the electrocardiograph and modifications during actual service life shall
be evaluated based on the requirements of IEC60601-1.

iSE Series Electrocardiograph Service Manual Safety Guidance
- 8 -
2.1.2 Li-ion Battery Care Warnings
WARNING
1. Improper operation may cause the internal li-ion battery (hereinafter called battery) to
be hot, ignited or exploded, and it may lead to the decrease of the battery capacity. It
is necessary to read the user manual carefully and pay more attention to warning
messages.
2. Only qualified service engineers authorized by the manufacturer can open the battery
compartment and replace the battery, and batteries of the same model and
specification as manufacturer configuration should be used.
3. DANGER OF EXPLOSION -- Do not reverse the anode and the cathode when
installing the battery.
4. Do not heat or splash the battery or throw it into fire or water.
5. Do not destroy the battery. Do not pierce battery with a sharp object such as a needle.
Do not hit with a hammer, step on or throw or drop to cause strong shock. Do not
disassemble or modify the battery.
6. When leakage or foul smell is found, stop using the battery immediately. If your skin
or cloth comes into contact with the leakage liquid, cleanse it with clean water at once.
If the leakage liquid splashes into your eyes, do not wipe them. Irrigate them with
clean water first and go to see a doctor immediately.
7. Properly dispose of or recycle the depleted battery according to local regulations.
8. Only when the device is off can the battery be installed or removed.
9. Remove the battery from the electrocardiograph when the electrocardiograph isn't
used for a long time.
10. If the battery is stored alone and not used for a long time, we recommend that the
battery be charged at least once every 6 months to prevent overdischarge.

SE-18 Series Electrocardiograph Service Manual Safety Guidance
- 9 -
2.1.3 General Cautions
CAUTION
1. Avoid liquid splash and excessive temperature. The temperature must be kept
between 5 ºC and 40 ºC during operation, and it should be kept between -20 ºC and
55 ºC during transportation and storage.
2. Do not use the equipment in a dusty environment with bad ventilation or in the
presence of corrosive.
3. Make sure that there is no intense electromagnetic interference source around the
equipment, such as radio transmitters or mobile phones etc. Attention: large medical
electrical equipment such as electrosurgical equipment, radiological equipment and
magnetic resonance imaging equipment etc. is likely to bring electromagnetic
interference.
4. The device and accessories are to be disposed of according to local regulations after
their useful lives. Alternatively, they can be returned to the dealer or the manufacturer
for recycling or proper disposal. Batteries are hazardous waste. Do NOT dispose of
them together with house-hold garbage. At the end of their lives hand the batteries
over to the applicable collection points for the recycling of waste batteries. For more
detailed information about recycling of this product or battery, please contact your
local Civic Office, or the shop where you purchased the product.
5. Federal (U.S.) law restricts this device to sale by or on the order of a physician.
2.2 List of Symbols
No.
Symbol
Description
1
DEFIBRILLATION-PROOF TYPE CF APPLIED
PART
2
Direct current
3
Caution
4
Consult operating instructions

SE-18 Series Electrocardiograph Service Manual Safety Guidance
- 10 -
5
Near-field communication
6
USB interface
7
SIM and SD cards slot (two-in-one)
8
Computer network
9
On/Off switch
10
General symbol for recovery/recyclable
11

Part Number
12

SERIAL NUMBER
13
Date of manufacture
14
MANUFACTURER
15
AUTHORISED REPRESENTATIVE IN THE
EUROPEAN COMMUNITY
16
CE marking
17
Disposal method
18
Caution: Federal (U.S.) law restricts this device to sale
by or on the order of a physician.
19
Refer to instruction manual/booklet
(Background: Blue; Symbol: White)

SE-18 Series Electrocardiograph Service Manual Safety Guidance
- 11 -
20
General warning sign
(Background: Yellow; Symbol & Outline: Black)
21
Non-ionizing electromagnetic radiation
22
This way up
23
Fragile, handle with care
24
Keep dry
25
Stacking limit by number
26
Handle with care
27
Do not step on
28
Front
NOTE: The manual is printed in black and white.

iSE Series Electrocardiograph Service Manual Overview
- 12 -
Chapter 3 Overview
The service manual is a reference for periodic preventive maintenance and corrective service
procedures for the 18-channel electrocardiograph.
WARNING
When performing a service procedure, follow the instructions in this manual exactly.
Failure to do so could damage the device, invalidate the product warranty, and lead to
serious personal injury.
This guide provides troubleshooting information, disassembly procedures, and instructions for
functional testing and performance verification. It is intended to be used by technically
qualified service personnel only.
3.1 Technical Specifications
3.1.1 Safety Standards
IEC 60601-1:2005/A1:2012
EN 60601-1:2006/A1:2013
IEC 60601-1-2:2014
EN 60601-1-2:2015
IEC/EN 60601-2-25
3.1.2 Classifications
Anti-electric-shock type:
Class І with internal power supply
Anti-electric-shock degree:
CF type with defibrillation-proof
Degree of protection against
harmful ingress of water:
Ordinary equipment (Sealed equipment without liquid proof)
Disinfection/sterilization
method:
Refer to the user manual for details

iSE Series Electrocardiograph Service Manual Overview
- 13 -
Degree of safety of
application in the presence
of flammable gas:
Equipment not suitable for use in the presence of flammable
gas
Working mode:
Continuous operation
EMC:
CISPR 11, Group 1, Class B
3.1.3 Environment Requirements
Transport & Storage
Working
Temperature:
-20ºC (-4ºF) ~ +55ºC (+131ºF)
+5ºC (+41ºF) ~ +40ºC (+104ºF)
Relative Humidity:
15% RH~95% RH
Non-Condensing
15% RH~95% RH
Non-Condensing
Atmospheric Pressure:
70kPa ~106kPa
70kPa ~106kPa
3.1.4 Power Supply Specifications
Mains supply
Operating Voltage = 100 V-240 V~
Operating Frequency = 50 Hz / 60 Hz
Power Adapter: Output Voltage = 19 V, Output Current = 2.53 A
Input current=1.1 A
Li-ion Battery
Rated Voltage / Typical Capacity = 15.2 V / 3550 mAh
When the battery is fully charged, iSE can work (without printing)
continuously at least 8 hours.
100% recharge time: ≤5 hours
90% recharge time: < 4 hours