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

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EDAN CONFIDENTIAL

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EDAN CONFIDENTIAL

About this Manual

P/N: 01.54.457373

MPN: 01.54.457373012

Release Date: November, 2016

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

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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EDAN CONFIDENTIAL

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

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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EDAN CONFIDENTIAL

SONOTRAX(2009) Series Ultrasonic Pocket Doppler User Manual

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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EDAN CONFIDENTIAL

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