EDAN SONOTRAX Pro User manual

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文件名称(Document Name)：SONOTRAX(2009)说明书_英语（A6版）
文件编号(Number)：01.54.457373
版本(Version)：1.2
产品型号(Product Model)：SONOTRAX(2009)
项目编码(Project Code)：2006A-1000
签批信息(Signature):
作者(Originator) : 王 璟 (wangjing) 2016-11-24 17:19:51
审核人(Reviewers) : 刘 小倩 (liuxiaoqian) 2016-11-25 18:31:52
审核人(Reviewers) : 黄 东 (huangdong) 2016-11-24 18:14:11
批准人(Approvers) : 王 力维 (wangliwei) 2016-12-02 10:03:44
批准人(Approvers) : 冀 伟 (jiwei) 2016-12-02 11:03:58
版权©深圳市理邦精密仪器股份有限公司 (Copyright©Edan Instrument,Inc.)
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I
About this Manual
P/N: 01.54.457373
MPN: 01.54.457373012
Release Date: November, 2016
© Copyright EDAN INSTRUMENTS, INC. 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
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II
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.
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III
Product Information
Product Name: Ultrasonic Pocket Doppler
Model: SONOTRAX Lite, SONOTRAX Basic,
SONOTRAX Basic A, SONOTRAX Pro,
SONOTRAX II, SONOTRAX II Pro,
SONOTRAX Vascular
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.
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IV
Contents
Chapter 1 Safety Guide.......................................... 1
1.1 Intended Use/Indications for Use................... 1
1.2 Safety Precautions.......................................... 2
1.3 Symbols........................................................ 11
Chapter 2 Doppler and Accessories.................... 13
2.1 Features ........................................................ 13
2.2 Main Unit..................................................... 17
2.2.1 Appearance............................................ 17
2.2.2 Display Panel ........................................ 19
2.2.3 Buttons.................................................. 21
2.2.4 Socket.................................................... 22
2.2.5 Probe Socket.......................................... 23
2.2.6 Batteries ................................................ 24
2.3 Probes........................................................... 26
2.3.1 Waterproof Obstetrical Probes.............. 26
2.3.2 Waterproof Vascular Probes ................. 27
Chapter 3 Basic Operation.................................. 28
3.1 Opening the Package and Checking............. 28
3.2 Installing/Replacing Battery......................... 28
3.3 Probe Operation............................................ 31
3.4 Switching on................................................. 34
3.5 Selecting Working Mode.............................. 35
3.6 Enabling or Disabling Backlight.................. 36
3.7 Switching Off............................................... 36
3.8 Replacing/Charging the Battery................... 37
3.8.1 Battery Energy Indication ..................... 37
3.8.2 Replacing Alkaline Batteries................. 38
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3.8.3 Charging the NI-MH Batteries.............. 39
3.8.4 Charging NI-MH Battery Pack ............. 40
Chapter 4 Examining........................................... 43
4.1 FH Examining.............................................. 43
4.2 FH Sound Recording and Playing................ 46
4.3 FH Sound Recording by PC......................... 47
4.3.1 Recording Sounds................................. 47
4.3.2 Playing Sound Files............................... 51
4.3.3 Burning CD or Sending in Email.......... 51
4.3.4 Record Troubleshooting........................ 51
4.4 Vascular Examining (Optional).................... 55
4.5 Completing Examining................................. 59
Chapter 5 Maintenance........................................ 60
5.1 Maintenance................................................. 60
5.2 Cleaning ....................................................... 60
5.3 Disinfection.................................................. 62
5.4 Sterilization .................................................. 62
Chapter 6 Warranty and Service........................ 64
6.1 Warranty....................................................... 64
6.2 Contact Information ..................................... 65
Appendix 1 Product Specifications..................... 66
Appendix 2 Ordering Information...................... 73
Appendix 3 EMC Information............................ 75
A3.1 Electromagnetic Emissions ....................... 75
A3.2 Electromagnetic Immunity........................ 78
A3.3 Electromagnetic Immunity........................ 82
A3.4 Recommended Separation Distances......... 86
Appendix 4 Ultrasound Intensity and Safety..... 89
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VI
A4.1 Ultrasound in Medicine............................. 89
A4.2 Ultrasound Safety and the ALARA Principle
............................................................................ 90
A4.3 Explanation of MI/TI................................. 90
A4.3.1 MI (Mechanical Index)....................... 90
A4.3.2 TI (Thermal Index)............................. 91
A4.3.3 Measurement Uncertainties................ 92
A4.4 Prudent Use Statement .............................. 94
A4.5 References for Acoustic Output and Safety94
A4.6 Probe Acoustic Output Parameters List..... 96
A4.7 Standard Parameters Equal Contrast List.104
Appendix 5 Overall Sensitivity...........................106
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SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual
1
Chapter 1 Safety Guide
NOTE:
This user manual is written to cover the
maximum configuration. Therefore, your model
may or may not have some of the parameters
and functions described, depending on what you
have ordered.
1.1 Intended Use/Indications for Use
The SONOTRAX Series Ultrasonic Pocket Dopplers
(hereinafter called “the Doppler”) are intended to be
used by health care professionals including registered
nurses, practical nurses, midwives, ultrasound
technicians, and physician assistants, by prescription
from licensed physicians in hospitals, clinics and
private offices.
The 2 MHz and/or 3 MHz waterproof probes are
indicated for the detection of fetal heart rate from
early gestation thru delivery and as a general
indication of fetal well being. They can also be used
to verify fetal heart viability.
The 4 MHz, 5 MHz and/or 8 MHz waterproof
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vascular probes are indicated for the detection of
blood flow in veins and arteries for assisting in the
detection of peripheral vascular disease.
1.2 Safety Precautions
This unit is internally powered equipment, and
it is an IEC/EN 60601-1 Type B applied part.
Type B protection means that the connection
between the equipment and personnel complies
with permitted leakage currents and dielectric
strength of IEC/EN 60601-1.
WARNING and CAUTION messages must be
observed. To avoid the possibility of injury, observe
the following precautions during the operation of the
device.
WARNING
1 The Doppler is a tool to aid the healthcare
professional and should not be used in place of
normal fetal monitoring. It is not intended for
treatment.
2 This device is not explosion-proof and can
not be used in the presence of flammable
anaesthetics.
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WARNING
3 Placement of the ultrasound transducer on
the abdomen is critical to obtaining the fetal
heart beat as opposed to maternal heart beat or
other abdominal noise. The user should be
trained in proper placement techniques either
through acceptable Ob/Gyn training and
individual state accreditation, or as being
prescribed by such a trained clinician and trained
in device placement.
4 The device is not protected against
defibrillation.
5 Do not use the device with HF surgical
equipment.
6 Do not touch the signal input/output
connector and the patient simultaneously.
7 Only use the probes provided by the
manufacturer.
8 We recommend that exposure to ultrasound
should be kept as low as reasonably achievable.
This is considered to be good practice and
should be observed at all time.
9 Do not heat or throw batteries in fire as this
may cause explosion.
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WARNING
10 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.
11 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 60601-1-1. 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
60601-1-1. If in doubt, consult our technical
service department or your local distributor.
12 Do not short-circuit the batteries or install
the batteries reversely.
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WARNING
13 Do not attempt to charge normal alkaline
batteries. They may leak, catch fire or even
explode.
14 Do not solder the leading wire and the
battery terminal directly.
15 Do not destroy the battery: Do not pierce the
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.
16 The battery should be charged, used or
stored away from the static electricity.
17 Remove the batteries and store them in a
cool and dry environment if the device is not
used for a long time.
18 If rechargeable batteries are used, charge
them fully before initial use by using the method
introduced in this manual.
19 The rechargeable NI-MH batteries and
battery pack should be charged by using the
dedicated adapters recommended or supplied
by the manufacturer.
20 Do not mix the battery with metal objects to
avoid short-circuit.
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WARNING
21 If the rechargeable batteries are stored
alone and not used for a long time, we
recommend that the batteries should be charged
at least once every 6 months to prevent
overdischarge.
22 Replacement of the battery or charging the
battery shall be done at least 1.5 meters away
from patients.
23 If the liquid leak from the battery spills onto
your skin or clothes, wash well with fresh water
immediately.
24 The device shall only be used when the
battery cover is closed.
25 If the liquid leak from the battery gets into
eyes, do not rub the eyes. Wash them well with
clean water and see a doctor immediately.
26 Keep away from fire immediately when
leakage or foul odor is detected.
27 Stop using the battery if abnormal heat, odor,
discoloration, deformation or abnormal condition
is detected during use, charge, or storage.
Please dispose it according to the local
regulations.
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WARNING
28 Batteries have life cycles. The alkaline
batteries are intended to be used once. If the
time that the Doppler using NI-MH battery
becomes much shorter than usual, the battery
life is at an end. Replace them with those of
identical specifications.
29 Do not immerse, throw, or wet the battery in
water/seawater.
30 Do not connect any equipment or
accessories that are not approved by the
manufacturer or that are not IEC 60601-1
approved to the device. The operation or use of
non-approved equipment or accessories with the
device is not tested or supported, and device
operation and safety are not guaranteed.
31 Using accessories other than those
specified by the manufacturer may result in
increased electromagnetic emissions or
decreased electromagnetic immunity of the
device.
32 Portable and mobile RF communications
equipment can affect medical electrical
equipment, refer to section A3.4 Recommended
Separation Distances.
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WARNING
33 The device should not be used adjacent to
or stacked with other equipment and that if
adjacent or stacked use is necessary, the device
should be observed to verify normal operation in
the configuration in which it will be used.
34 The medical electrical equipment needs to
be installed and put into service according to the
EMC Information provided in this user manual.
35 Do not service or maintain the device or any
accessory which is in use with a patient.
CAUTION
1 Federal (U.S.) law restricts this device to
sale by or on the order of a physician.
2 Refer servicing to qualified personnel.
3 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).
4 Keep the device in a clean environment and
avoid vibration during storage.
5 Do not sterilize the Doppler with autoclave
or gas.
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SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual
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CAUTION
6 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.
7 Prior to examination using the Doppler,
check for visible damages of the main unit and
the probe that may endanger the
patient/operator or machine performance. If the
damage is found, replace them with good ones
at once.
8 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.
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CAUTION
Test the pregnant woman’s leakage current
according to IEC 60601-1: Limit: d.c 10 µA, a.c
100 µA.
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.
9 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. At the end of
their life 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.
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SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual
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1.3 Symbols
No.
Symbol
Definition
1
CE marking
2
Disposal method
3
Caution: Federal (U.S.) law
restricts this device to sale by
or on the order of a physician.
4
Operating instructions
5
Caution
6
Current: Direct
7
TYPE B APPLIED PART
8
Part Number
9
SERIAL NUMBER
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10
Date of manufacture
11
MANUFACTURER
12
AUTHORISED
REPRESENTATIVE IN THE
EUROPEAN COMMUNITY
13
General symbol for
recovery/recyclable
14
Power adapter connector
15
Headphones
16
Refer to User Manual
(Background: Blue; Symbol:
White)
17
Warning
(Background: Yellow;
Symbol&Outline: Black)
NOTE:
The user manual is printed in black and white.
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