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文件名称(Document Name):SD3维修手册_英文
文件编号(Number):01.54.000639
版本(Version):1.0
产品型号(Product Model):SD3;SD3 LITE;SD3 PLUS;SD3 PRO
项目编码(Project Code):2209A000
签批信息(Signature):
作者(Originator) : 陈, 泳研 (chenyongyan) 2015-05-19 14:43:20
审核人(Reviewers) : 程, 亮 (chengliang) 2015-05-19 15:40:32
审核人(Reviewers) : 黄, 东 (huangdong) 2015-05-19 14:53:55
批准人(Approvers) : 王, 力维 (wangliwei) 2015-05-26 08:40:51
批准人(Approvers) : 张, 刚 (zhanggang) 2015-05-25 11:18:55
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.
I
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
1 Warranty and Service ................................................................................................................. 1
2 Safety Guide................................................................................................................................. 2
2.1 Introduction ............................................................................................................................ 2
2.2 General Information ............................................................................................................... 2
2.3 Safety Precautions .................................................................................................................. 2
3 Installation ................................................................................................................................... 5
3.1 Environmental Requirements ................................................................................................. 5
3.2 Power Supply Requirements .................................................................................................. 5
3.3 Safety Requirements ............................................................................................................... 5
3.4 Installing the Doppler ............................................................................................................. 6
3.4.1 Putting the Doppler on a Flat Surface .............................................................................. 6
3.4.2 Installing the Doppler on a Trolley .................................................................................. 6
3.4.3 Installing the Charge Stand (SD3 PLUS, SD3 PRO) ....................................................... 6
3.5 Connecting to AC Power ........................................................................................................ 7
4 Overview ...................................................................................................................................... 8
4.1 Principle Introduction ............................................................................................................. 8
4.2 Appearance and Interfaces...................................................................................................... 8
5 Tests and Maintenance.............................................................................................................. 10
5.1 Functional Check .................................................................................................................. 10
5.1.1 Switching on Check ....................................................................................................... 10
5.1.2 Screen Check .................................................................................................................. 10
5.1.3 Keys Check .................................................................................................................... 10
5.1.4 Probe Check ................................................................................................................... 10
5.2 Performance Test .................................................................................................................. 11
5.3 Safety Test ............................................................................................................................ 11
5.3.1 Patient Leakage Current Test ......................................................................................... 12
5.4 Maintenance.......................................................................................................................... 12
5.4.1 Maintenance of the Main Unit ....................................................................................... 12
5.4.2 Maintenance of the Probe............................................................................................... 12
5.4.3 Maintenance of the Battery ............................................................................................ 13
6 Troubleshooting ......................................................................................................................... 14
7 Module Malfunction Verification ............................................................................................ 16
7.1 Verifying Malfunction of the Main Board ............................................................................ 16
8 Disassembling the Doppler ....................................................................................................... 18
8.1 Tools Required ...................................................................................................................... 18
8.2 Replacing Batteries ............................................................................................................... 18
8.3 Disassembling the Main Unit ............................................................................................... 19
8.4 Replacing the Main Board .................................................................................................... 20
8.5 Replacing the Speaker .......................................................................................................... 21
8.6 Replacing the Charge Adapter Board ................................................................................... 22
8.7 Disassembling the Charge Stand .......................................................................................... 22
8.8 Replacing the Charge Board of the Charge Stand ................................................................ 23
8.9 Replacing the Interface Board of the Charge Stand ............................................................. 24
Appendix 1 Renewal Parts .......................................................................................................... 25
III
SD3 Series Ultrasonic Pocket Doppler Service Manual Warranty and Service
-1-
SD3 Series Ultrasonic Pocket Doppler Service Manual Safety Guide
2 Safety Guide
2.1 Introduction
This service manual is a reference for periodic preventive maintenance and corrective service
procedures for the SD3 series ultrasonic pocket Doppler.
It provides troubleshooting information, disassembly and 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 as presented in this manual.
Failure to do so might damage the device, invalidate the product warranty or lead to
serious personal injury.
WARNING
1 The Doppler 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-
SD3 Series Ultrasonic Pocket Doppler Service Manual Safety Guide
WARNING
2 The service personnel must be familiar with the operation of the Doppler. Refer to the
SD3 Series Ultrasonic Pocket Doppler User Manual for details.
3 This device is not explosion-proof and can not be used in the presence of flammable
anaesthetics.
4 SHOCK HAZARD - Do not attempt to connect or disconnect a power cord with wet
hands. Make certain that your hands are clean and dry before touching a power
cord.
5 Do not touch the signal input/output connector and the patient simultaneously.
6 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 system standard IEC/EN
60601-1. Anybody who 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 60601-1. If in doubt, consult our technical service department or your local
distributor.
7 Only use the probes provided by the manufacturer. Use and replace the substitutive
parts provided or recommended by EDAN only.
8 The device shall only be used when the battery cover is closed.
CAUTION
1 The main unit is designed for continuous operation and is ‘ordinary’. Do not immerse
it in any liquid (i.e. not drip or splash-proof).
2 Keep the device in a clean environment and avoid vibration during storage.
3 Do not sterilize the Doppler with autoclave or gas.
4 Electromagnetic Interference - Ensure that the environment in which the device is
operated is not subject to any source of strong electromagnetic emissions, such as
radio transmitters, mobile telephones, etc.
5 The following safety checks should be performed once every two years or as
specified in the institution’s test and inspection protocol by a qualified person who has
adequate training, knowledge, and practical experience to perform these tests.
Inspect the equipment for mechanical and functional damage.
Inspect the safety relevant labels for legibility.
Verify that the device functions properly as described in the instructions for use.
Test the pregnant woman’s leakage current according to IEC 60601 Limit: d.c
10 µA, a.c 100 µA.
-3-
SD3 Series Ultrasonic Pocket Doppler Service Manual Safety Guide
CAUTION
The leakage current should never exceed the limit. The data should be recorded in
an equipment log. If the device is not functioning properly or fails any of the above
tests, the device has to be repaired.
6 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
them together with house-hold garbage.
-4-
SD3 Series Ultrasonic Pocket Doppler Service Manual Installation
3 Installation
WARNING
The device should only be installed by qualified service engineers.
CAUTION
1 Ensure that the device is not subject to any source of strong electromagnetic
emissions, such as radio transmitters, mobile phones, etc.
2 Do not install the device in the presence of flammable anesthetics.
3 Keep the environment clean. Avoid vibration. Keep the device far from corrosive
medicine, dust area, high-temperature and humid environment.
-5-
SD3 Series Ultrasonic Pocket Doppler Service Manual Installation
-6-
SD3 Series Ultrasonic Pocket Doppler Service Manual Installation
WARNING
1 The charge stand can be fixed only on a concrete wall.
2 When you need to install the charge stand a second time, drill new holes and change
the screws.
WARNING
1 Make sure that the batteries are not connected reversely before plugging the charger
into the power socket.
2 The Doppler is not available for examination during charging.
-7-
SD3 Series Ultrasonic Pocket Doppler Service Manual Overview
4 Overview
4.1 Principle Introduction
The ultrasonic Doppler is the essential principle applied to the device.
The ultrasonic Doppler principle is as follows: When the ultrasound wave from the emitter
crystal encounters an active fetal heart, Doppler shift happens. As a result, there is a frequency
offset between the received ultrasound wave and the emitted ultrasound wave. The receiver
crystal receives the ultrasound wave and converts it to electric signals. The fetal heart sound is
acquired after the electric signals are amplified by the front end and processed by the
demodulation and filtering circuit. With envelope detection and autocorrelation algorithm, the
device calculates the fetal heart rate.
Screen
Probe socket
Audio socket
Volume
Battery control
compartment
Power
Charge socket button
-8-
SD3 Series Ultrasonic Pocket Doppler Service Manual Overview
Figure 4-2 and Figure 4-3 shows the main board interfaces of each model respectively.
Probe J6 J2(+) V
R Volume
J4 1 control
Earphone socket
Ba
ttery
J1(-)
Speaker J7
Figure 4-2 Main board interfaces of SD3 LITE, SD3 and SD3 VASCULAR
Probe detection
SW3
Probe J6 J2(+) V
R Volume
J4 1 control
Battery
Earphone or audio
cable interface J8
SW2
Charge socket J1(-)
Record/Play
J9
button
Figure 4-3 Main board interfaces of SD3 PLUS and SD3 PRO (SW2 not available in SD3 PLUS)
-9-
SD3 Series Ultrasonic Pocket Doppler Service Manual Tests and Maintenance
WARNING
Qualified service personnel should perform complete functional checks after the device is
installed to ensure proper running of the device.
Press the POWER button on the front panel to switch on the Doppler. The OLED
screen displays .
If the probe is not connected or poorly connected, the OLED screen displays . You
should reconnect the probe properly.
When the probe is well connected, the OLED screen shows the probe frequency, for example,
- 10 -
SD3 Series Ultrasonic Pocket Doppler Service Manual Tests and Maintenance
Probe
- 11 -
SD3 Series Ultrasonic Pocket Doppler Service Manual Tests and Maintenance
NOTE:
The circuit diagram is based on the Fluke 601Pro series safety analyzer.
This test measures the patient leakage current of the DUT and its applied part located within the
patient environment.
Allowable value:
Normal condition (NC): AC: 100 µA, DC: 10 µA (IEC/EN60601-1)
5.4 Maintenance
For details about basic cleaning and maintenance methods, refer to the Maintenance chapter in
the SD3 Series Ultrasonic Pocket Doppler User Manual. For further technical support, contact
service engineers of EDAN.
- 12 -
SD3 Series Ultrasonic Pocket Doppler Service Manual Tests and Maintenance
- 13 -
SD3 Series Ultrasonic Pocket Doppler Service Manual Troubleshooting
6 Troubleshooting
A damaged PCB or part can be replaced. If replacement is necessary, refer to Chapter 8 for
details.
- 14 -
SD3 Series Ultrasonic Pocket Doppler Service Manual Troubleshooting
The screen displays nothing Power adapter defective. Replace the power adapter.
or displays charge error Battery defective. Replace the battery.
when the Doppler (SD3
PLUS or SD3 PRO) is being Main board defective. Replace the main board.
charged. Charge stand defective. Replace the charge stand.
- 15 -
SD3 Series Ultrasonic Pocket Doppler Service Manual Module Malfunction Verification
TP2
- 16 -
SD3 Series Ultrasonic Pocket Doppler Service Manual Module Malfunction Verification
TP4 TP5
4) If any of the results exceeds the reference range, the main board is considered defective.
Replacement of the main board is recommended.
- 17 -
SD3 Series Ultrasonic Pocket Doppler Service Manual Disassembling the Doppler
WARNING
The direction of the battery should comply with the polar mark in the battery compartment.
Reversed connection is forbidden.
Alkaline batteries
or rechargeable
Battery cover NI-MH batteries
Tab
- 18 -
SD3 Series Ultrasonic Pocket Doppler Service Manual Disassembling the Doppler
Lithium battery
Battery cover
Upper unit
Lower unit
Main board
Speaker
- 19 -
SD3 Series Ultrasonic Pocket Doppler Service Manual Disassembling the Doppler
Lower unit
Upper unit
Main board
Speaker
Charge adapter
board
- 20 -
SD3 Series Ultrasonic Pocket Doppler Service Manual Disassembling the Doppler
Volume control
button
Interface panel
Interface panel
Cable interface
Cable interface
Speaker
- 21 -
SD3 Series Ultrasonic Pocket Doppler Service Manual Disassembling the Doppler
Cable interface
- 22 -
SD3 Series Ultrasonic Pocket Doppler Service Manual Disassembling the Doppler
Front unit Rear unit Rear unit Interface board Front unit
Cable interface
Charge board
- 23 -
SD3 Series Ultrasonic Pocket Doppler Service Manual Disassembling the Doppler
Interface board
Cable interface
- 24 -
SD3 Series Ultrasonic Pocket Doppler Service Manual Renewal Parts
CAUTION
Only connect the replaceable parts supplied by EDAN to the Doppler.
Speaker 01.14.038036
Cable in the Doppler (SD3 PLUS and
01.13.036579
SD3 PRO)
Cable in the Doppler (SD3 LITE, SD3
01.13.036578
and SD3 VASCULAR)
Earphone 01.14.000831
- 25 -
SD3 Series Ultrasonic Pocket Doppler Service Manual Renewal Parts
- 26 -