EDAN SONOTRAX Pro Bedienungsanleitung
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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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EDAN CONFIDENTIAL
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EDAN CONFIDENTIAL
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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EDAN CONFIDENTIAL
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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EDAN CONFIDENTIAL
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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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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EDAN CONFIDENTIAL
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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SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual
2
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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