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EDAN SONOTRAX Pro User Manual

EDAN SONOTRAX Pro
116 pages
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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.)
理邦保密文件
EDAN CONFIDENTIAL

Table of Contents

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EDAN SONOTRAX Pro Specifications

General IconGeneral
BrandEDAN
ModelSONOTRAX Pro
CategoryMedical Equipment
LanguageEnglish

Summary

Chapter 1 Safety Guide

1.1 Intended Use/Indications for Use

Describes the intended medical use of the SONOTRAX Series Ultrasonic Pocket Dopplers for fetal heart rate detection.

1.2 Safety Precautions

Details essential safety precautions, warnings, and cautions for operating the device.

1.3 Symbols

Explains various symbols used in the manual and on the device for clear understanding.

Chapter 2 Doppler and Accessories

2.1 Features

Provides an overview of the different SONOTRAX models and their general functionalities.

2.2 Main Unit

Details the physical appearance and components of the main SONOTRAX Doppler unit.

2.2.2 Display Panel

Describes the LED indicators and LCD screen elements of the SONOTRAX Doppler.

2.2.3 Buttons

Explains the functions of the push buttons and volume control on the Doppler unit.

2.2.4 Socket

Details the types and functions of the earphone and charge sockets on the Doppler.

2.2.5 Probe Socket

Describes the probe socket, including its jack definitions and connections.

2.2.6 Batteries

Explains the types of batteries used by different SONOTRAX models and their power sources.

2.3 Probes

Describes the different types of waterproof obstetrical and vascular probes available for the Doppler.

Chapter 3 Basic Operation

3.1 Opening the Package and Checking

Guides users through unpacking and inspecting the Doppler and its accessories for damage.

3.2 Installing/Replacing Battery

Provides step-by-step instructions for installing and replacing batteries in the SONOTRAX Doppler.

3.3 Probe Operation

Explains how to take out, place, and replace the ultrasound probes for the Doppler.

3.4 Switching on

Details the procedure for powering on the SONOTRAX Doppler unit.

3.5 Selecting Working Mode

Describes the four available working modes for the Doppler and how to select them.

3.6 Enabling or Disabling Backlight

Explains how to turn the backlight on or off for specific SONOTRAX models.

3.7 Switching Off

Outlines the procedure for turning off the SONOTRAX Doppler unit.

3.8 Replacing/Charging the Battery

Covers battery replacement, charging instructions, and battery energy indications.

Chapter 4 Examining

4.1 FH Examining

Guides users on performing Fetal Heart (FH) examinations using the Doppler.

4.2 FH Sound Recording and Playing

Describes how to record and play fetal heart sounds using specific SONOTRAX models.

4.3 FH Sound Recording by PC

Explains how to transfer and record fetal heart sounds onto a PC.

4.3.2 Playing Sound Files

Details how to play back recorded fetal heart sound files on a computer.

4.3.3 Burning CD or Sending in Email

Guides on saving recorded sound files to CDs or sending them via email.

4.3.4 Record Troubleshooting

Provides solutions for common issues encountered during sound recording on a PC.

4.4 Vascular Examining (Optional)

Explains how to perform vascular examinations using the Doppler with specific probes.

4.5 Completing Examining

Provides instructions for safely concluding a Doppler examination procedure.

Chapter 5 Maintenance

5.1 Maintenance

Outlines general maintenance checks and procedures for the Doppler unit and probes.

5.2 Cleaning

Provides detailed instructions for cleaning the main unit and probes of the Doppler.

5.3 Disinfection

Explains the disinfection procedures for the main unit and probes.

5.4 Sterilization

Advises on when and how sterilization of the Doppler may be required.

Chapter 6 Warranty and Service

6.1 Warranty

Details the terms and conditions of the EDAN product warranty and its limitations.

6.2 Contact Information

Provides contact details for EDAN service, distributors, and support channels.

Appendix 1 Product Specifications

Appendix 2 Ordering Information

Appendix 3 EMC Information

A3.1 Electromagnetic Emissions

Details guidance and declarations regarding electromagnetic emissions from the Doppler.

A3.2 Electromagnetic Immunity

Details guidance and declarations regarding electromagnetic immunity of the Doppler.

A3.3 Electromagnetic Immunity

Discusses electromagnetic immunity with respect to specific IEC standards and guidance.

A3.4 Recommended Separation Distances

Provides recommended distances for portable/mobile RF equipment to ensure safe operation.

Appendix 4 Ultrasound Intensity and Safety

A4.1 Ultrasound in Medicine

Discusses the benefits and safety considerations of diagnostic ultrasound in medical practice.

A4.2 Ultrasound Safety and the ALARA Principle

Explains the ALARA principle for minimizing patient exposure to ultrasound.

A4.3.1 MI (Mechanical Index)

Explains the Mechanical Index (MI) and its relation to potential cavitation effects.

A4.3.2 TI (Thermal Index)

Explains the Thermal Index (TI) and its relation to tissue heating from ultrasound.

A4.3.3 Measurement Uncertainties

Details the sources and values of measurement uncertainties in the device's performance.

A4.4 Prudent Use Statement

Advises on the prudent use of ultrasound equipment to avoid potential bioeffects.

A4.5 References for Acoustic Output and Safety

Lists references and standards related to acoustic output and safety in ultrasound.

Appendix 5 Overall Sensitivity

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