EDAN FTS-3 User manual

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文件名称：FTS-3维修手册_英文
文件编号：01.54.456401
版本：1.3
产品型号：FTS-3
项目编码：2213A000
签批信息:
作者 : 欧阳 飞燕 (ouyangfeiyan) 2016-10-31 10:22:16
审核人 : 刘 小倩 (liuxiaoqian) 2016-11-01 16:30:18
审核人 : 罗 崇 (luochong) 2016-11-02 13:16:33
批准人 : 王 力维 (wangliwei) 2016-11-08 15:49:36
批准人 : 冀 伟 (jiwei) 2016-11-04 09:34:50
版权©深圳市理邦精密仪器股份有限公司
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EDAN CONFIDENTIAL

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I
About this Manual
P/N: 01.54.456401
MPN: 01.54.456401013
Release Date: Oct. 2016
© Copyright EDAN INSTRUMENTS, INC. 2014-2016. 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 ME EQUIPMENT that are designated by EDAN as repairable by
SERVICE PERSONNEL.
Using This Label Guide
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
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II
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.
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III
Table of Contents
Chapter 1 Warranty and Service.................................................................................................1
Chapter 2 Overview......................................................................................................................4
2.1 Introduction ........................................................................................................................... 4
2.2 General Information .............................................................................................................. 4
2.3 Safety Precautions ................................................................................................................. 4
2.4 Definitions and Symbols .......................................................................................................7
Chapter 3 Installation...................................................................................................................8
3.1 Environment Requirements................................................................................................... 8
3.2 Electrical Requirements......................................................................................................... 9
3.3 Safety Requirements.............................................................................................................. 9
3.4 Installing FTS-3..................................................................................................................... 9
3.4.1 Installing the Base Station on a Flat Surface ..................................................................9
3.4.2 Mounting the Base Station on a Wall .............................................................................9
3.4.3 Installing FTS-3 on a Roll Stand/Trolley...................................................................... 11
3.5 Connecting Power Cable..................................................................................................... 12
Chapter 4 Functional Checks..................................................................................................... 13
Chapter 5 System Configuration...............................................................................................14
5.1 Adjusting the Working Channel.......................................................................................... 14
Chapter 6 Maintenance .............................................................................................................. 15
6.1 Maintenance Inspection....................................................................................................... 15
6.2 Maintenance of the Base Station ......................................................................................... 16
6.3 Maintenance of the Transducers.......................................................................................... 16
Chapter 7 Principle Introduction ..............................................................................................17
7.1 System Principle Block Diagram ........................................................................................ 17
7.1.1 Main Board ...................................................................................................................17
7.1.2 Indicative Light Board .................................................................................................. 19
7.1.3 Charge Interface Board .................................................................................................20
7.1.4 Power module ...............................................................................................................21
7.2 Interface and Key.................................................................................................................22
7.2.1 DB15 Interface.............................................................................................................. 22
7.2.2 Working Channel Key ..................................................................................................23
Chapter 8 Troubleshooting.........................................................................................................24
Chapter 9 Modules’ Malfunction Verification.........................................................................25
9.1 Verifying Malfunction of the Main Board...........................................................................25
9.2 Verifying Malfunction of the Power module.......................................................................26
9.3 Verifying Malfunction of the Indicative Light Board.......................................................... 27
Chapter 10 Disassembling FTS-3 ..............................................................................................28
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10.1 Tools Required................................................................................................................... 28
10.2 Blown Fuses ...................................................................................................................... 28
10.3 Disassembling the Base Station......................................................................................... 29
10.4 Disassembling the Upper assembly...................................................................................33
10.4.1 Replacing the Charging Interface Board..................................................................... 33
10.4.2 Replacing the Indicative Light Board......................................................................... 34
10.5 Disassembling the Lower assembly .................................................................................. 34
10.5.1 Replacing the Power Module...................................................................................... 34
10.5.2 Replacing the Main Board .......................................................................................... 36
10.5.3 Replacing the Fan........................................................................................................ 37
Chapter 11 Periodic Tests ..........................................................................................................38
11.1 Safety Tests....................................................................................................................... 38
11.2 Performance Tests........................................................................................................... 38
11.2.1 FHR Performance Test................................................................................................ 38
11.2.2 TOCO Performance Test ............................................................................................. 39
11.2.3 ECG Performance Test................................................................................................40
11.2.4 DECG Performance Test............................................................................................. 41
Appendix 1 Renewal Parts .........................................................................................................42
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FTS-3 Fetal Telemetry System Service Manual Warranty and Service
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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 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.
ii) The customer signs the Declaration Form and sends it back by email or fax. This form is
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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.
Contact Information
If you have any question about maintenance, technical specifications or malfunctions of devices,
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do not hesitate to contact us.
EDAN Instruments, Inc.
TEL: [phone]
FAX: [phone]
E-mail: [email protected]
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Chapter 2 Overview
NOTE:
This service manual is written to cover the maximum configuration. Therefore, your
model may not have some of the parameters/modules described, depending on what you
have ordered.
2.1 Introduction
FTS-3 fetal telemetry system can be used with F6 or F9 series fetal/maternal monitor. This
service manual is a reference for periodic preventive maintenance and corrective service
procedures for FTS-3.
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 to do so might damage FTS-3, invalidate the product warranty or lead to serious personal
injury.
2.2 General Information
FTS-3 fetal telemetry system (hereinafter called FTS-3) is designed to comply with the
international safety requirements IEC/EN 60601-1 for medical electrical equipment. It is
class I equipment.
The protective degree against electric shock of the patient connections is:
Ultrasound (FHR1, FHR2)
External TOCO
Type BF
DECG, MHR(form MECG)
Type CF
FTS-3 described in this manual is not protected against:
a) The effects of high frequency currents
b) The interference of electrosurgery equipment
2.3 Safety Precautions
WARNING and CAUTION messages must be observed. To avoid the possibility of injury,
observe the following precautions during the maintaining the instrument.
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WARNING
1 FTS-3 is provided for the use of qualified physicians or personnel professionally
trained. They should be familiar with the contents of this user manual before
operation.
2 FTS-3 is not intended for use in intensive care units (ICU), operating rooms or for
home use.
3 Do not switch on the base station until all cables have been properly connected and
verified.
4 To avoid the danger of introducing additional hazards, do not perform any
unauthorized modification of FTS-3.
5 EXPLOSION HAZARD - Do not use FTS-3 in the presence of flammable anesthetics
or other materials.
6 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.
7 Do not touch accessible parts of non-medical electrical equipment and the patient
simultaneously. Do not touch the signal input or output connector and the patient
simultaneously.
8 The service personnel should be familiar with the operation of FTS-3. Refer to
F9+F9E Fetal & Maternal Monitor User Manual for details.
9 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.
10 Do not exceed the maximum permitted load when using multiple portable
socket-outlets to supply the system.
11 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. 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.
12 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.
13 Multiple portable socket-outlets shall not be placed on the floor.
14 SHOCK HAZARD - Do not remove the top panel cover during operation or while
power is connected.
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WARNING
15 Equipment and devices that connect to FTS-3 should form an equipotential body to
ensure effective grounding.
16 Only connect accessories supplied or recommended by the manufacturer to the
device.
17 Do not apply FTS-3 during electro-surgery or MRI; otherwise it might result in harming
the patient or the operator.
18 Electromagnetic Interference - Ensure that the environment in which the monitor or
FTS-3 is installed is not subject to any source of strong electromagnetic interference,
such as CT, radio transmitters, mobile phone base stations, etc. Even though other
devices are in accordance with national standard radiation requirements, the monitor
or FTS-3 may be interfered.
19 Please arrange a function test periodically for the system.
20 Do not move the system when it is powered on and do not soak it in any liquid.
21 Please check the transducer, cable and base station periodically. If the transducers
are damaged, do not use them in water and repair them in time.
22 If the transducer has been beaten or knocked, please check whether the cover is
airproof or damaged. If you have any doubt, please contact the manufacturer or local
agent.
23 If the battery in the base station is stored alone and not used for a long time, we
recommend that the battery should be charged at least once every 6 months to
prevent overdischarge.
24 The battery in the wireless transducer should be replaced by the serviceman
authorized by EDAN.
25 Do not service or maintain the system or any accessory which is in use with the
patient.
CAUTION
1 Turn off the power supply before cleaning.
2 Electromagnetic Interference - Do not use mobile phones nearby in the process of
monitoring.
3 Electromagnetic Interference - FTS-3 system should not be used adjacent to, or
stacked with, other equipment unless otherwise specified.
4 Electromagnetic interference is not unique to this system but is characteristic of fetal
patient monitoring equipment in use today. This performance is due to very sensitive
high gain front end amplifiers required to process the small physiological signals from
the patient. Among the various monitoring systems already in clinical use,
interference from electromagnetic sources is rarely a problem.
5 The device and reusable accessories could be sent back to the manufacturer for
recycling or proper disposal after their useful lives.
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CAUTION
6 The wireless transducers are IPX8 waterproof, but the base station should be kept
non-soaked and non-condensing. The system may be condensing during
transportation in high humidity or low temperature.
7 The use of accessories and cables other than those specified may result in increased
electromagnetic emissions or decreased electromagnetic immunity of the system.
8 This equipment generates uses and radiates radio-frequency energy, and if it is not
installed and used in accordance with its accompanying documentation, may cause
interference to radio communications.
9 When the battery is charged, used or stored, keep it away from objects or materials
with static electric charges.
10 If the terminals of the battery become dirty, wipe with a dry cloth before using the
battery.
11 The recommended charging temperature for the battery is between 0°C ~ +40°.
Please do not exceed the temperature range.
12 Batteries have life cycles. If the time that FTS-3 using battery becomes much shorter
than usual, the battery life is at an end. Please contact the manufacturer to replace
the battery with a new one of the same specification as the one provided or
recommended by the manufacturer.
13 Remove the battery in the base station and store it at a cool and dry environment if
the system is not used for a long time.
14 Please remove the battery out of the transducer at the end of their life. Please read
the user manual carefully when you install or remove the battery.
2.4 Definitions and Symbols
Non-ionizing electromagnetic radiation
Serial Number
Wireless Transducer Working Indicator
USB Port (Reserved)
Ethernet Port (Reserved)
Channel Adjustment
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Chapter 3 Installation
WARNING
Only qualified service engineers should install this equipment.
3.1 Environment Requirements
Environment
Working
Temperature:
+5 ºC ~ +40 ºC ( +41ºF ~ +104ºF)
Relative
Humidity:
15% ~ 93% (non-condensing)
Atmospheric
Pressure:
86 kPa ~ 106 kPa
Transport
and Storage
Temperature:
-20 ºC ~ +55 ºC (-4ºF ~ +131 ºF)
Relative
Humidity:
15% ~ 93% (non-condensing)
Atmospheric
Pressure:
70 kPa ~ 106 kPa
Classification
Anti-electric Shock Type:
Class I equipment with internal power supply
Anti-electric Shock Degree:
FHR1, FHR2, TOCO BF
DECG, MHR(form MECG) CF
Transducer Degree of Protection
against Harmful Ingress of Water:
IPX8 (Protected against the effects of continuous
immersion in water 1.1m deep for 24 hours)
Degree of Safety in Presence of
Flammable Gases:
Equipment not suitable for use in presence of
flammable gases
Disinfection/Sterilizing Method:
Refer to User Manual for details
EMC:
CISPR11 Group 1 Class A
Working System
Continuous running equipment
NOTE:
1. Ensure FTS-3 is not subject to any source of strong electromagnetic interference, such
as CT, radio transmitters, mobile phones base stations, etc.
2. Do not install FTS-3 in a flammable atmosphere where concentrations of flammable
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anesthetics or other materials may occur.
3. Keep the environment clean. Avoid vibration. Keep it far from corrosive medicine, dust
area, high-temperature and humid environment.
3.2 Electrical Requirements
Operating Voltage: 100V-240V~
Operating Frequency: 50Hz/60Hz
Maximum Input Current: ﹤0.8A
Battery: 14.8VDC/5000mAh
3.3 Safety Requirements
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 base station
to fit a two-slot outlet. If the outlet has only two slots, make sure that it is replaced with
a three-slot grounded outlet before attempting to operate the base station.
Do not touch signal input or output connector and the patient simultaneously.
Equipment and devices that connect to FTS-3 should form an equipotential body to
ensure effective grounding.
Do not switch on the base station until all cables have been properly connected and
verified.
3.4 Installing FTS-3
3.4.1 Installing the Base Station on a Flat Surface
Place FTS-3 on a flat surface. Make sure the surface does not vibrate, and is free of corrosive
medicine and dust. Keep it distant from the metal or shielded material and devices with strong
radiation. Please donot place it in the shielded room. Keep a distance of at least 1.5m from the
device of the same type.
3.4.2 Mounting the Base Station on a Wall
WARNING
1. FTS-3 should only be mounted on a solid concrete or brick wall.
2. Make sure the wall mounting board is firmly fixed to the wall. If there is any doubt, do not hang
FTS-3 to this board.
3. Make sure the base station is safely hung on the posts of the board before releasing your hands
from the base station.
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1. FTS-3 can be used with F3 wall mounting component (02.04.118143) which you can order.
Figure 2- 1
2. Order a outer wall mounting board (01.52.107983), a wall mounting board (01.52.01983) and
a connecting board (01.52.107984).
3. Fix the connecting board on the wall mounting board with two M3*6 cross head screws. Fix
the connecting board and the wall mounting board in the inner wall mounting board with six
M3*8 cross head spring washer and flat washer package M3*8. Fix the outer wall mounting
board on the wall with six M3*20pan head cap screw.
Figure 2- 2
F3 wall mounting
component
Base station and
transducer
Wall mounting board
M3*6 Pan head screw
M3*6 Pan head screw
Screnw
Connecting board
Cross head spring washer and flat
washer package M3*8 (semi-adhesive)
Inner wall mounting board
Outer wall mounting board
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4. Hang the wall mounting board on the hook of the outer wall mounting board and fix the connecting board
and the outer wall mounting board with one M3*6 pan head screw.
Figure 2- 3
3.4.3 Installing FTS-3 on a Roll Stand/Trolley
FTS-3 can also be used with MT-803.
1. Stick the Velcro fixing tape on the bottom of the base station.
Figure 2- 4
挂墙连接板
挂墙外板
Press riveting SUS304hook
Wall
M3*20 pan head cap screw
Outer wall mounting board
Opposite press riveting M3 bolt
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2. Fix the base station on the middle tray and ensure that it will not fall off when crossing the
steps.
Figure 2- 5 FTS-3 on a Trolley (Sketch Map)
3.5 Connecting Power Cable
Make sure the AC power supply of the system complies with the following specification:
100V-240V~, 50Hz/60Hz.
WARNING
If the protective grounding (protective earth) system is doubtful, the power of the system must be
supplied by internal power supply only.
NOTE:
1 Make sure the system and the power outlet are placed at a place where it is easy to
connect and disconnect the power cord.
2 When AC mains are interrupted, the device switches to internal power supply and
operates normally if the battery is installed. If the battery is not installed, the system
shuts down and resumes the previous settings at the subsequent operation.
3 After the AC power supply is connected, please wait for at least 2 seconds before
pressing the POWER switch to turn on the system.
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Chapter 4 Functional Checks
This section describes the procedure of a complete functional test to support recommended
preventive-maintenance schedules.
You are not required to open the device case for functional checks.
WARNING
Only qualified service personnel should perform a full functional check procedure.
Whenever the system is serviced or problems are suspected, the manufacturer recommends a full
functional check procedure.
Please test the system after each service.
1. Power on the base station and connect it to the fetal monitor.
2. Charge the transducer.
3. Power on the monitor.
4. Take up the US-T transducer and test the following function:
The US-T transducer screen displays the standard start interface.
The US-T transducer indicator is green.
The fetal monitor screen displays US1 or US2.
5. Simulate the audio frequency signal：
The fetal monitor displays FHR.
6. Take up the TOCO-T transducer or TOCO-E transducer and test the following function:
The TOCO-T or TOCO-E transducer screen displays the standard start interface.
The TOCO-T or TOCO-E transducer indicator is green.
The monitor screen displays TOCO.
7. Touch the measuring area of the TOCO-T or TOCO-E transducer gently：
The fetal monitor displays TOCO value change.
8. Install the US-T transducer to charge：
The US-T transducer screen displays charging interface and charging state.
The US-T transducer indicator is off.
The fetal monitor screen has no display.
9. Install the TOCO-T or TOCO-E transducer to charge：
The TOCO-T or TOCO-E transducer screen displays charging interface and charging
state.
The TOCO-T or TOCO-E transducer indicator is off.
The fetal monitor screen has no display.
10. It takes about 3.5 hours to fully charge the US-T transducer, TOCO-T transducer and
TOCO-E transducer.
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Chapter 5 System Configuration
The end users can not change the system configurations. As a service engineer, you need to
change these configurations for them after FTS-3 is installed and checked properly.
NOTE:
Restart the base station after changing the settings.
5.1 Adjusting the Working Channel
If the fetal heart sound is with interference or it cannot be played smoothly, the working channel
is probably interfered. Put all the transducers back in the docking slots and press the adjustment
button in back of the base station. The channel range is 1-14.
Restart the system when it enters the charging interface.
NOTE：
The working channel number used by a system cannot be duplicated with that used by a
device of the same type.
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