GE Vivid S60 DNA Extraction Module Catalog #12016408EDU Instruction Manual

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Technical Publications

0459

Vivid™ S70 / Vivid S60

Version 203

User Manual BC092760-1EN — English

Rev. 01

Operating Documentation

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Regulatory requirement

0459

This product complies with regulatory requirements of the following European Directive 93/42/EEC concerning medical devices.

This manual is a reference for the Vivid S70 and Vivid S60 ultrasound systems and covers the following models: Vivid S70 v203 and Vivid S60 v203. It applies to all revisions of the 203 software for the Vivid S70 and Vivid S60 ultrasound systems, which will hereafter be listed as Vivid S70 / S60. All information in this manual is relevant for the two systems unless otherwise specified.

© GE Medical Systems. All rights reserved. No part of this manual may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written permission of GE Medical Systems.

COMPANY DATA GE Medical Systems, Israel Ltd.

Nativ Ha’or Street no.1 3508510, Haifa ISRAEL Tel: (+972) 4 8519 555 Fax: (+972) 4 8519 500

GE Medical Systems SCS 283 rue de la Minière, 78530 BUC, France

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Revision History

Reason for change

DATE

REV

Rev. 01 2019-01-30 Initial release

(YYYY-MM-DD)

List of Effective Pages

PAGE NUMBER REV

All pages Rev. 01

Please verify that you are using the latest revision of this document. Information pertaining to this document is maintained on ePDM (GE electronic Product Data Management). If you need to know the latest revision, contact your distributor, local GE Sales Representative or in the USA call the GE Ultrasound Clinical Answer Center at 1 800 682 5327 or 1 262 524 5698.

REASON FOR CHANGE

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Regulatory Requirements

Conformance Standards

The GE Healthcare product families are tested to meet all applicable requirements and relevant standards per the countries in which the product will be sold. Any changes to accessories, peripheral units, or any other part of the system must be approved by the manufacturer: GE Vingmed Ultrasound AS. Ignoring this advice may compromise the regulatory approvals obtained for the product.

This product complies with the regulatory requirements of the following:

Standard/Directive Scope

93/42/EEC Medical Devices Directive (MDD)

2012/19/EU Waste Electrical and Electronic Equipment (WEEE)

2011/65/EU Directive on the restriction of the use of certain hazardous substances in

IEC/EN 60601-1 ANSI/AAMI ES60601-1 CAN/CSA-C22.2 No. 60601-1

IEC/EN 60601-2-37 Medical electrical equipment - Part 2-37. Particular requirements for the

IEC/EN 60601-1-2 Medical Electrical Equipment - Part 1-2. General requirements for basic

IEC/EN 60601-1-6 Medical Electrical Equipment - Part 1-6. General requirements for basic

NEMA/AIUM UD-3 Standard for real-time display of thermal and mechanical acoustic output

IEC/EN 62304 Medical Device Software - Software life-cycle processes

IEC/EN 62366 Medical Devices - Application of usability engineering to medical devices

ISO 10993-1 Biological evaluation of medical devices

electrical and electronic equipment (ROHS)

Medical Electrical Equipment - Part 1. General requirements for basic Safety and essential performance

basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests

safety and essential performance - Collateral standard: Usability

indices on diagnostic ultrasound equipment.

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Certifications

GE Medical Systems Türkiye Ltd. Şti. Esentepe Mah. Harman Sok. No: 8 34394 Şişli İstanbul Türkiye

Türkiye İthalatçısı / Turkish Importer

• Quality management standards for medical devices: GE

Importer Information

• TURKEY

• BRAZIL

Medical Systems, Israel Ltd. and GE Medical Systems, China Co. Ltd. are ISO13485 certified.

Brazilian Importer

GE Healthcare do Brasil Comércio e Serviços para Equipamentos Médico- Hospitalares Ltda Av. Magalhães de Castro, 4800 Andar 11 Conj. 111 e 112, Andar 12 Conj. 121 e 122, Torre 3 - Cidade Jardim São Paulo SP – CEP: 05676-120 C.N.P.J.: 00.029.372/0001-40 Número de Registro ANVISA: 80071260360

Directives

The GE ultrasound product families are tested to meet all applicable requirements in relevant EU Directives and European/International standards.

• Council Directive 93/42/EEC concerning MDD (Medical Devices Directive): the CE label affixed to the product testifies compliance to this Directive.

The location of the CE marking is specified in ‘Device labels’ on page 2-26.

• Year of first CE mark: 2015

Classifications

According to 93/42/EEC Medical Device Directive, this is a Class IIa Medical Device.

The following classifications are in accordance with the IEC/ EN 60601-1:

• According to IEC/EN 60601-1, Equipment is Class I, with BF or CF Applied Parts.

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Class I Equipment

Type of protection against electric shock:

• Class I Equipment

Degree of protection against electric shock:

• Type BF Applied part (for Probes marked with BF symbol)

• Type CF Applied part (for ECG, and probes marked with CF symbol)

• The ECG applied part is protected against defibrillation.

Continuous Operation

System is IPX0.

Footswitch is IPX8.

Transducers are IPX7.

ICE catheters are IPX8.

EQUIPMENT in which protection against electric shock does not rely on BASIC INSULATION only, but also includes an earth ground. This additional safety precaution prevents exposed metal parts from becoming LIVE in the event of an insulation failure.

Type BF Applied part

TYPE BF APPLIED PART providing a specified degree of protection against electric shock with particular regard to allowable LEAKAGE CURRENT.

Patient leakage current

Normal condition Single fault condition

d.c. <10 microA <50 microA

a.c. <100 microA <500 microA

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Type CF Applied part

TYPE CF APPLIED PART providing a degree of protection higher than that for Type BF Applied Part against electric shock particularly regarding allowable LEAKAGE CURRENT.

Patient leakage current

Normal condition Single fault condition

d.c. <10 microA <50 microA

a.c. <10 microA <50 microA

Original Documentation

The original document was written in English.

Software License Acknowledgements

WindowBlinds™ OCX © Stardock ®

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Conformance Standards - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-2 Certifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-3 Importer Information - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-3 Directives- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-3 Classifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-3 Class I Equipment- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-4 Type BF Applied part - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-4 Type CF Applied part - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-5 Original Documentation- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-5 Software License Acknowledgements- - - - - - - - - - - - - - - - - - - - - - - - - - i-5

Table of Contents Chapter 1 — Introduction

Overview

Attention - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-2 Documentation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3 Conventions used in this manual - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3 Indications for use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-4 Contraindications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-7 Prescription device - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-7 Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-7

Contact Information

Contacting GE Ultrasound - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-8 Manufacturer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-14

Chapter 2 — Safety

Safety Precautions

Precaution Levels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-2

Owner responsibility

Notice against user modification- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-3

Acoustic output

Definition of the acoustic output parameters - - - - - - - - - - - - - - - - - - - - 2-4 Acoustic output and display on the Vivid S70 / S60 - - - - - - - - - - - - - - - 2-5 ALARA - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-7 Safety statement- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-7 System controls affecting acoustic output - - - - - - - - - - - - - - - - - - - - - - 2-8 OB Exam - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-10

Important safety considerations

Patient safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-11 Personnel and equipment safety - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-15 Electromagnetic Compatibility (EMC) - - - - - - - - - - - - - - - - - - - - - - - - 2-19

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Environmental protection- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-25

Device labels

Symbols- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-26 For China only - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-30

Chapter 3 — Prepare the System for Use

Site requirements

Power requirements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-2 Operating Environment - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-3 Environmental requirements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-3 Electromagnetic interferences - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-3 Connecting the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-4

System Overview

Getting to know the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-9 Removable media- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-11 Physiological traces - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-14 Peripheral/accessory connector panel - - - - - - - - - - - - - - - - - - - - - - - 3-19 Wired Footswitch (Option) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-21

Switching On/Off

Switch on the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-23 Log In - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-23 Switch off the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-24

Connect and disconnect probes

Connect the probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-26 Activate the probe- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-28 Deactivate the probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-30 Disconnect the probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-30 Intra Cardiac Ultrasound Catheters- - - - - - - - - - - - - - - - - - - - - - - - - - 3-31

The Scanning screen

The Title bar- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-33 Parameters window - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-34 Clipboard - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-34

Control panel

Control Panel overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-35 Trackball area - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-37 Touch panel - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-38 The alphanumeric keyboard (option)- - - - - - - - - - - - - - - - - - - - - - - - - 3-42

Main display adjustment

Lock/unlock the main display - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-44 Image Adjustment- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-45

Moving and transporting the system

Wheels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-48 Moving the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-48 Using Transportation mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-51 Transporting the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-52 Reinstalling at a new location- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-53 Preparing Vivid S70 / S60 for scanning - - - - - - - - - - - - - - - - - - - - - - - 3-53

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Chapter 4 — Start an Examination

Starting an examination

Creating a new patient record - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-2 Selecting an existing patient record - - - - - - - - - - - - - - - - - - - - - - - - - - 4-3 Ending an examination - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-3

Cineloop

Cineloop overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-6 Using cineloop - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-7

Zoom

Display zoom - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-9 HR zoom - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-9

Annotations

To insert an annotation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-10 Editing annotations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-12 To erase text annotations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-13 Bodymark - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-13 Annotation and bodymark configuration - - - - - - - - - - - - - - - - - - - - - - 4-14

Chapter 5 — Image Optimization

2D-Mode

2D-Mode overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-3 Using 2D-Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-5 Optimizing 2D- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-5

M-Mode

M-Mode overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-7 Using M-Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-9 Optimizing M-Mode- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-11

Color Mode

Color 2D Mode overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-12 Color M-Mode overview- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-14 Using Color Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-16 Optimizing Color Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-16

PW and CW Doppler

PW and CW Doppler overview- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-19 Using PW/CW Doppler modes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-21 Optimizing PW/CW Doppler modes - - - - - - - - - - - - - - - - - - - - - - - - - 5-21

Tissue Velocity Imaging (TVI)

TVI overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-23 Using TVI- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-25 Optimizing TVI - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-25

Tissue Tracking

Tissue Tracking overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-26 Using Tissue Tracking- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-28 Optimizing Tissue Tracking - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-28

Strain rate

Strain rate overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-29 Using Strain rate- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-31 Optimizing Strain rate - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-31

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Strain

Strain overview- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-32 Using Strain - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-34 Optimizing Strain - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-34

Tissue Synchronization Imaging (TSI)

TSI overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-35 Using TSI- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-37

Contrast Imaging

Data acquisition - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-39 Quantification - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-44 Contrast Echocardiography Box- - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-45

Additional scanning features

LogiqView - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-46 Compound - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-47 Virtual Convex - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-47 B-Flow - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-47 Blood Flow Imaging - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-48

Image controls

Control panel - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-49 Touch panel and rotaries - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-49

Scan Assist Pro

Scan Assist Pro overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-59 Setting up Scan Assist Pro - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-61 Using Scan Assist Pro- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-63

Chapter 6 — 4D and Multi-plane Modes

4D-Mode

Real-time, single beat 4D imaging - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-2 Real-time, multi beat 4D imaging - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-2 4D-Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-3 4D Color Flow mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-14 Flexi-Slice - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-18 Basic operations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-20 4D-Mode controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-28

Multi-plane mode

Bi-plane mode screen - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-35 Tri-plane mode screen - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-37 Using Multi-plane mode- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-39 Bi-plane prepare - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-39 Basic operations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-41 Multi-plane mode controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-43

FlexiViews

Chapter 7 — Stress Echo

Introduction Selection of a stress test protocol template Image acquisition

Starting acquisition - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-5 Continuous capture mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-9

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Stress Echo analysis

Image selection for analysis- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-16 Wall motion scoring- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-18

Quantitative TVI Stress echo analysis

Accessing QTVI Stress analysis tools - - - - - - - - - - - - - - - - - - - - - - - - 7-22 Vpeak measurement - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-22 Tissue Tracking - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-25 Quantitative analysis - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-25 References - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-25

Editing/creating a Stress Echo protocol template

Entering the Template editor screen - - - - - - - - - - - - - - - - - - - - - - - - - 7-26 Editing/Creating a template - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-27

Chapter 8 — Measurements and Analysis

Introduction

General recommendations about measurements- - - - - - - - - - - - - - - - - 8-4 About Measurement results display - - - - - - - - - - - - - - - - - - - - - - - - - - 8-4

Assign and Measure modality Measure and Assign modality

Measurements on volume renderings - - - - - - - - - - - - - - - - - - - - - - - - - 8-9

Measurements on protocol images

Example results - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-10

Advanced cardiac measurements and analysis

Event timing measurements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-11 TSI Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-12 Automated Function Imaging - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-18 Cardiac AutoDoppler- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-46 Pediatric Z-score measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-49

4D/Multi-plane LV

4D/multi-plane LV analysis tools- - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-50 4D Auto LVQ - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-50 Manual left ventricular volume measurements- - - - - - - - - - - - - - - - - - 8-60 TSI surface model- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-65

4D Auto MVQ

Requirements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-67 Starting 4D Auto MVQ- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-68 Align Views - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-69 Set Landmarks - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-70 Review - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-72 Results - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-73 Approval - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-75

4D Auto AVQ

Requirements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-76 Starting the 4D Auto AVQ tool - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-77 Slice alignment - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-78 LVOT segmentation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-78 Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-80 Approval - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-81

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Advanced vascular measurements and analysis

Intima-Media Thickness- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-82 Vascular AutoDoppler - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-85

OB measurements

OB graphs - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-87

Measurement result table

Minimizing the Measurement result table - - - - - - - - - - - - - - - - - - - - - 8-93 Moving the Measurement result table - - - - - - - - - - - - - - - - - - - - - - - - 8-93 Deleting measurements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-93

Worksheet

Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-94 Using the Worksheet- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-95

Measurement accuracy

General - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-97 Sources of error - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-97 Optimizing Measurement Accuracy - - - - - - - - - - - - - - - - - - - - - - - - - 8-99 Measurement Uncertainties - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-99

Chapter 9 — Quantitative Analysis

Introduction Q Analysis overview

Starting Q Analysis - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-3 Q Analysis screen- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-4

Using Q Analysis

Generation of a trace - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-9 Saving/retrieving Q Analysis - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-13 Frame disabling - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-13 Optimization - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-15 Switching modes or traces - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-19 Anatomical M-Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-20

Chapter 10 — Archiving

Introduction The dataflow concept

Dataflows available - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-3

Storing images and cineloops

Storing an image - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-7 Storing a cineloop - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-8 Saving images and cineloops to a standard format - - - - - - - - - - - - - - 10-9 EZ DICOM CD Viewer- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-11

Retrieving and editing archived information

Searching for a patient record - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-14 Editing data in the archive - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-17 Deleting archived information- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-25 Moving examinations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-27

Review images in archive

Review the images from a selected examination - - - - - - - - - - - - - - - 10-29 Review images from a selected patient record- - - - - - - - - - - - - - - - - 10-31

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Connectivity

The dataflow concept - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-36 Dataflow selection- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-39

Transfer of patient records/examinations

Transfer patient records/examinations between archives - - - - - - - - - 10-40 Transferring patient records/examinations- - - - - - - - - - - - - - - - - - - - 10-41

Disk management

Configuring the Disk management function - - - - - - - - - - - - - - - - - - - 10-49 Running the Disk management function - - - - - - - - - - - - - - - - - - - - - 10-52

Data Backup and restore

Backup procedure- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-57 Restore procedure - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-61

Tricefy

To register a Tricefy account - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-64 Configuration of Tricefy storage - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-65 TricefyPatientShare - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-66 Storing an exam in Tricefy - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-68 Configuration of Tricefy QR - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-70

Data streaming

Streaming in process - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-71

Chapter 11 — Report

Introduction Creating a report Working with the report function

To open a report - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-4 To choose another report template- - - - - - - - - - - - - - - - - - - - - - - - - - 11-6 To change patient information - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-6 Images in the report - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-6 To print a report - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-7 To store a report - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-7 Retrieving an archived report - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-8 Deleting an archived report - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-8

Structured Findings

Prerequisite - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-9 Starting Structured Findings- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-10 Using Structured Findings - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-12 Structured Findings configuration - - - - - - - - - - - - - - - - - - - - - - - - - - 11-14

Direct report

Creating comments- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-25 Creating pre-defined text inputs - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-26

Report designer

Accessing the Report designer- - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-27 Report designer overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-28 Designing a report template - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-30 Saving the report template - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-42 To exit the Report designer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-42

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Report templates management

Configuration of the Template selection menu- - - - - - - - - - - - - - - - - 11-44 Export/Import of Report templates - - - - - - - - - - - - - - - - - - - - - - - - - 11-45

Chapter 12 — Customize Configuration

Customize System Settings

About system Configuration - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-2 General system settings - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-4

Touch Panel

Shortcuts - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-6

Users and Security

Local System Users - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-8 User Policies - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-11 LDAP- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-12 System password - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-14 Storage Encryption - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-15

Global imaging settings

Global imaging settings - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-18

Measurement Package

Basic operations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-19 Measurement package configuration - example- - - - - - - - - - - - - - - - 12-21 User-defined formulas - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-23 Advanced settings - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-31 Normal values - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-38 Transfer of user-defined measurements transfer in DICOM SR- - - - - 12-39 Advanced Quantification - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-40

Connectivity configuration

System in a network environment- - - - - - - - - - - - - - - - - - - - - - - - - - 12-42 System in a network environment with a DICOM server - - - - - - - - - - 12-43 Wireless Network Configuration - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-54 Data Streaming - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-60

Introduction

The Vivid S70 / S60 is a high perfo rmance digital ultrasound imaging system with tot al d at a manage ment.

The system provides image generation in 4D (option on Vivid S70), 2D (B) Mode, Color Doppler, Power Doppler (Angio), M-Mode, Color M-Mode, PW and CW Doppler spectral, Tissue Velocity imaging, advanced Strain and Contrast applications.

The fully digital architecture of the Vivid S70 / S60 system allows optimal usage of all scanning mo des and probe types, throughout the full spectrum of operating frequencies.

This chapter provides information concerning indications for use/contraindications, contact information, and how this documentation is organized.

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Introduction

Attention

Overview

This manual contains necessary and sufficient information to operate the ultrasound system safely.

Read and understand all instructions in the User Manual before attempting to use the ultrasound system.

Keep this manual with the equipment at all time. Periodically review the procedures for operation and safety precautions.

Disregarding information on safety is considered abnormal use.

Not all features or products described in this document may be available or cleared for sale in all markets. Please contact your local GE Healthcare representative to get the latest information.

NOTE: Please note that orders are based on the individually agreed

upon specifications and may not contain all featur es listed in this manual.

NOTE: All references to standards / regulations and their revisions are

valid at the time of publication of the user manual.

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Documentation

CAUTION

Overview

Safety instructions must be reviewed before operating the system.

Vivid S70 / S60 documentation consists of various manuals:

• The User Manual and Onboard Help (TRANSLATED) provides information needed by the user to operate the system safely. It describes the basic functions of the system, safety features, operating modes, measurements/ calculations, probes, and user care and maintenance.

• The Advanced Reference Manual (ENGLISH ONLY) contains data tables, such as measurements and calculations, OB, and Acoustic Output.

• The Service Manual (ENGLISH ONLY) supplies block diagrams, lists of spare parts, descriptions, adjustment instructions, or similar information which helps qualified technical personnel in repairing those parts of the system which have been defined as repairable.

• Medical Ultrasound Safety publication from American Institute of Ultrasound in Medicine (AIUM) (ENGLISH ONLY). Provided as ALARA Educational Program, to comply with US FDA Track 3 - Not available in all countries.

NOTE: The eDocumentation kit provides instructions on how to read the

user documenation via electronic media. All user manuals are provided in electronic format. The eDocumenation media includes English and all other translations.

The Vivid S70 / S60 manuals are written for users who are familiar with basic ultrasound principles and techniques. They do not include sonographic training or detailed clinical procedures.

NOTE: The screen graphics in this manual are only for illustrational

purposes. Actual screen output may differ.

Conventions used in this manual

Bold type describes button names on the screen.

Italic type describes program windows, screens and dialogue boxes.

Icons highlight safety issues as described in ‘Safety’ on page 2-1.

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Introduction

Indications for use

The Vivid S70 / S60 is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis of Fetal/Obstetrics; Abdominal (Including Renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional; Musculo-skeletal Superficial; Urology (including prostate); Transesophageal; Transvaginal; Transrectal; Intra-cardiac; Intra-luminal; and Intraoperative (abdominal, thoracic, & vascular).

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Probe applications/indications table

Probe

2D (P2D)

6D (P6D)

M5Sc-D

3Sc-RS

12S-D

6S-D

9L-D

11L-D

C1-5-D

C1-6-D

C2-9-D

C3-10-D

6VT-D

6Tc-RS

9T-RS

10T-D

iC5-9-D

Clinical

Application

Anatomy/Region

of Interest

Ophthalmic

Fetal/Obstetrics +++ +++ +

Abdominal +++++ ++++

Renal/GYN/Pelvic +++++ ++++

Aorto-Iliac Artery ++ +++ +

Pediatric ++++ +

Small Organ + + +

L8-18i-D

Overview

SoundStar 3D 10F

AcuNav 10F

AcuNav 8F

SoundStar eco 10F

SoundStar eco 8F

Breast/testes/thyroid + + +

Neonatal Cephalic + + +

Adult Cephalic + +

Cardiac (Adult and Pediatric)

Cardiac (Adult) + +

Peripheral Vascular ++ +++++++ +++

Musculoskeletal Conventional

Musculoskeletal Superficial

Urology/Prostate + + + +

Exam type, Means of Access:

Transesophagael ++++

Transrectal +

Transvaginal +

Transurethral

++++ ++ +

++ + +

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Introduction

Clinical

Application

Anatomy/Region

of Interest

M5Sc-D

3Sc-RS

6S-D

12S-D

9L-D

11L-D

C1-5-D

C1-6-D

C3-10-D

C2-9-D

Probe

6VT-D

SoundStar 3D 10F

SoundStar eco 10F

SoundStar eco 8F

AcuNav 10F

L8-18i-D

AcuNav 8F

9T-RS

iC5-9-D

10T-D

6Tc-RS

2D (P2D)

6D (P6D)

Intraoperative (Abdominal/ Thoracic (cardiac)/ Vascular (PV))

Intraoperative Neurological

Intravascular

Interventional Guidance:

Intracardiac and Intraluminal

Tissue Biopsy ++ +++++ +

Vacular Access (IV, PICC)

++ ++ +

Frequency of use

Daily (Typically 8 hours)

Operator profile

• Qualified and trained physicians or sonographers with at least basic ultrasound knowledge.

• The operator must have read and understood the user manual.

+++++

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Contraindications

CAUTION

Prescription device

Safety

Overview

The Vivid S70 / S60 is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye.

Vivid S70 / S60 should be used in compliance with law. Some jurisdictions restrict certain uses, such as gender determination.

For USA only:

CAUTION: Federal law restricts this device to sale or use by or on the order of a physician.

All information in Chapter ‘Safety’ on page 2-1, should be

read and understood before operating the ultrasound system.

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Introduction

Contact Information

Contacting GE Ultrasound

For additional information or assistance, please contact your local distributor or the appropriate support resource listed on the following pages:

INTERNET http://www.gehealthcare.com

http://www3.gehealthcare.com/en/Products/Categories/ Ultrasound/Ultrasound_Probes

Clinical Questions For information in the United States, Canada, Mexico, and parts

of the Caribbean, call the Customer Answer Center. TEL: (1) 800-682-5327 or (1) 262-524-5698

In other locations, contact your local Applications, Sales, or Service Representative.

Service Questions For service in the United States, call GE CARES.

TEL: (1) 800-437-1171

In other locations, contact your local Service Representative.

Information Requests

Placing an Order To order accessories, supplies, or service parts in the United

To request technical product information in the United States, call GE.

TEL: (1) 800-643-6439

In other locations, contact your local Applications, Sales, or Service Representative.

States, call the GE Technologies Contact Center.

TEL: (1) 800-558-5102

In other locations, contact your local Applications, Sales, or Service Representative.

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AMERICAS

A A

GE Healthcare Ultrasound Service Engineering 9900 Innovation Drive Wauwatosa, WI 53226 TEL: (1) 800-668-0732 Customer Answer Center TEL: (1) 262-524-5698

GE Healthcare Ultrasound Service Engineering 9900 Innovation Drive Wauwatosa, WI 53226 TEL: (1) 262-524-5300 Customer Answer Center TEL: (1) 262-524-5698

GE Healthcare Ultrasound Service Engineering 9900 Innovation Drive Wauwatosa, WI 53226 TEL: (1) 800-437-1171 FAX: (1) 414-721-3865

ARGENTINA

CANADA

Contact Information

GE Healthcare TEL: 11-5298-2400 Nicolas Vedia 3616, piso 5 Buenos Aires

BRAZIL

GE Healthcare do Brasil Comércio e Serviços para Equipamentos Médico- Hospitalares Ltda

v. Magalhães de Castro, 4800, Andar 11 Conj. 111 e 112,

ndar 12 Conj. 121 e 122, Torre 3 - Cidade Jardim CEP: 05676-120 - São Paulo/SP - Brasil C.N.P.J.: 00.029.372/0001-40 TEL: 3004 2525 (Capitais e regiões metropolitanas) / 0800 165 799 (Demais regiões)

LATIN & SOUTH

AMERICA

MEXICO

USA

GE Sistemas Medicos de Mexico S.A. de C.V. Rio Lerma #302, 1º y 2º Pisos Colonia Cuauhtemoc FAX: (5) 211-4631 06500-Mexico, D.F. TEL: (5) 228-9600

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Introduction

ASIA

ASIA PACIFIC

AUSTRALIA

KOREA

NEW ZEALAND

SINGAPORE

JAPAN

CHINA

GE Healthcare Asia Pacific 4-7-127, Asahigaoka Hinoshi, Tokyo 191-8503, Japan TEL: +81 42 585 5111

GE Healthcare 32 Philip Street Parramatta, NSW 2150 TEL: 1300 722 229 or +612 9846 4000

GE Healthcare - China No. 1, Yongchang North Road Beijing Economic & Technology Development Area Beijing 100176, China TEL: (8610) 5806 8888 FAX: (8610) 6787 1162

GE Healthcare Korea 15F, 416 Hangang Dae ro, Chung-gu Seoul, 04637, Korea TEL: +82 1544 6119

8 Tangihua Street

uckland 1010 New Zealand TEL: 0800 434 325

GE HEALTHCARE PTE LTD 1 Maritime Square #13-01 HarbourFront Center Singapore 099253 TEL: +65 6291 8528

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EUROPE and MIDDLE EAST

GE Healthcare BVBA Eagle Building Kouterveldstraat 20 1831 DIEGEM TEL: (+32) 2 719 7204 FAX: (+32) 2 719 7205

GE Healthcare 8-10 Sorou Str. Marousi Athens 15125 Hellas TEL: (+30) 210 8930600 FAX: (+30) 210 9625931

For all other European countries not listed, please contact your local GE Healthcare distributor or the appropriate support resource listed on www.gehealthcare.com.

AUSTRIA

General Healthcare Austria GmbH & Co OG Technologiestr. 10, Euro Plaza Gebäude E 1120 Wien TEL: (+43) 1 97272 0 FAX: (+43) 1 97272 2222

BELGIUM &

LUXEMBURG

CZECH REPUBLIC

GE Medical Systems Bucharova 14/2641, Explora Business 158 00 Praha

DENMARK

GE Medical Systems Ultrasound Park Alle 295, 2605 Brøndby TEL: (+45) 43 295 400 FAX: (+45) 43 295 399

ESTONIA &

FINLAND

FRANCE

GERMANY

GREECE

GE Healthcare Finland Oy Kuortaneenkatu 2, 000510 Helsinki P.O.Box 330, 00031 GE Finland TEL: (+358) 10 39 48 220 FAX: (+358) 10 39 48 221

GE Medical Systems SCS 24 Avenue de l'Europe - CS20529 78457 Velizy Villacoublay Cedex TEL: (+33) 13 449 50 00 FAX: (+33) 13 44 95 202

GE Healthcare GmbH Beethovenstrasse 239 42655 Solingen TEL: (+49) 212-28 02-0 FAX: (+49) 212-28 02 380

Contact Information

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Introduction

HUNGARY

IRELAND

NETHERLANDS

NORWAY

GE Hungary Zrt. Ultrasound Division

kron u. 2. Budaörs 2040 Hungary TEL: (+36) 23 410 314 FAX: (+36) 23 410 390

GE Healthcare 3050 Lake Drive, Citywest Business Campus Dublin 24 TEL: (+353) 1 4605500

ITALY

GE Medical Systems Italia spa Via Galeno, 36, 20126 Milano TEL: (+39) 02 2600 1111 FAX: (+39) 02 2600 1599

GE Healthcare B.V. De Wel 18, 3871 MV Hoevelaken PO Box 22, 3870 CA Hoevelaken TEL: (+31) 33-25 41 222

GE Healthcare Vitaminveien 1A, 0485 Oslo TEL: (+47) 23 18 50 50

POLAND

PORTUGAL

RUSSIA

SPAIN

GE Healthcare Strandpromenaden 45, P.O. Box 141, 3191 Horten TEL: (+47) 33 02 11 16

GE Medical Systems Polska Sp. z o.o., ul. Woloska 9 02-583 Warszawa, Poland TEL: (+48) 22 330 83 00 FAX: (+48) 22 330 83 83

General Electric Portuguesa SA SA. Avenida do Forte, n° 6-6A Edificio Ramazzotti, 2790-072 Carnaxide TEL: (+351) 21 425 1300 FAX: (+351) 21 425 1343

GE Healthcare 12th floor, 10C, Presnenskaya nab. Moscow 123317 Russia TEL: (+7) 495 739 69 31 FAX: (+7) 495 739 69 32

GE Healthcare España C/ Gobelas 35-37 28023 Madrid TEL: (+34) 91 663 2500 FAX: (+34) 91 663 2501

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SWEDEN

SWITZERLAND

TURKEY

UNITED ARAB

EMIRATES (UAE)

UNITED KINGDOM

Contact Information

GE Healthcare Sverige AB FE 314, SE-182 82 Stockholm, Sweden TEL: (+46) 8 559 50010

GE Medical Systems (Schweiz) AG Europastrasse 31, 8152 Glattbrugg TEL: (+41) 1 809 92 92 FAX: (+41) 1 809 92 22

GE Healthcare Türkiye Istanbul Office Levent Ofis Esentepe Mah. Harman Sok. No:8 Sisli-Istanbul TEL: +90 212 398 07 00 FAKS: +90 212 284 67 00

GE Healthcare Holding ME SA Dubai Internet City, Building No. 18 P. O. Box # 11549, Dubai U.A.E TEL: (+971) 4 429 6161 FAX (+971) 4 429 6200/01/02

GE Healthcare

mersham Place Little Chalfont, Bucks, HP7 9NA TEL: (+44) (0) 1494 544000

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Introduction

Manufacturer

GE Medical Systems, Israel Ltd. Nativ Ha’or Street no.1 3508510, Haifa, ISRAEL Tel.: (+972) 4 8519 555 Fax: (+972) 4 8519 500

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Chapter 2

Safety

Describes the safety and regulatory information pertinent to operating this ultrasound system as well as procedures for simple care and maintenance of the system.

‘Safety Precautions’ on page 2-2 ‘Owner responsibility’ on page 2-3 ‘Acoustic output’ on page 2-4 ‘Important safety considerations’ on page 2-11 ‘Device labels’ on page 2-26.

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Safety

DANGER

WARNING

CAUTION

Precaution Levels

Icon description

Safety Precautions

Various levels of safety precautions may be found on the equipment, and different levels of severity are identified by one of the following icons that precede precautionary statements in the text.

Indicates that a specific hazard is known to exist which through inappropriate conditions or actions will cause:

• Severe or fatal personal injury

• Substantial property damage

Indicates that a specific hazard is known to exist which through inappropriate conditions or actions may cause:

• Severe personal injury

• Substantial property damage

Indicates that a potential hazard may exist which through inappropriate conditions or actions will or can cause:

• Minor injury

• Property damage

NOTE: Indicates precautions or recommendations that should be used

in the operation of the ultrasound system, specifically:

• Maintaining an optimum system environment

• Using this Manual

• Notes to emphasize or clarify a point

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Owner responsibility

CAUTION

Owner responsibility

For USA only:

CAUTION: Federal law restricts this device to sale by or on the order of a physician.

It is the responsibility of the owner to ensure that anyone operating the system reads and understands this section of the manual. However, there is no representation that the act of reading this manual renders the reader qualified to operate, inspect, test, align, calibrate, troubleshoot, repair, or modify the system. The owner should make certain that only properly trained, fully-qualified service personnel undertake the installation, maintenance, troubleshooting, calibration, and repair of the equipment.

The owner of the ultrasound system should ensure that only properly trained, fully qualified personnel are authorized to operate the system. Before authorizing anyone to operate the system, it should be verified that the person has read, and fully understands, the operating instructions contained in this manual. It is advisable to maintain a list of authorized operators.

Should the system fail to operate correctly, or not respond to the commands described in this manual, the operator should contact GE Service.

For information about specific requirements and regulations applicable to the use of electronic medical equipment, consult local, state, and federal agencies.

Notice against user modification

Never modify this product, including system components, software, cables, etc. User modification may cause safety hazards and degradation in system performance. All modification must be done by a GE qualified person.

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Safety

Acoustic output

Definition of the acoustic output parameters

Thermal Index

TI is an estimate of the temperature increase of soft tissue or bone. There are three thermal index categories:

• TIS: Soft tissue thermal index. The main TI category. Used for applications that do not image bone.

• TIB: Bone thermal index (bone located in a focal region). Used for fetal application.

• TIC: Cranial bone thermal index (bone located close to the surface). Used for transcranial application.

Mechanical Index

Ispta

The Vivid S70 / S60 has an internal limit of 3.0 on TI for the chosen index category.

MI is the estimated likelihood of tissue damage due to cavitation. The absolute maximum regulatory limit of the MI is 1.9 as set by the FDA 510(k) guidance of September 9, 2008.

The maximum MI values obtainable with Vivid S70 / S60 in relevant operating modes, and with available ultrasound probes, are found in the Reference manual.

The Ispta is the Spatial Peak Temporal Average Intensity. The absolute maximum regulatory limit of Ispta is 720 mW/cm set by the FDA 510(k) guidance of September 9, 2008.

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Acoustic output and display on the Vivid S70 / S60

In the title bar, two fields are allocated for the display of power values as shown in Figure 2-1.

1. Title bar

2. MI

3. TI

Figure 2-1. The display of MI and TI on the screen

The Vivid S70 / S60 chooses the correct category based on mode of operation and chosen application, and presents the relevant TI category to the operator. It is therefore important that the operator chooses the right application. The system also provides the ability to select the display of any of the TI categories regardless of the current application.

The British Medical Ultrasound Society has suggested some maximum scanning times relative to displayed TI as follows:

Acoustic output

Obstetric scanning

TI time Note

0.0–0.7 Unlimited Monitor TIS up to 10 weeks post LMP, TIB thereafter

0.7–1.0 < 60 min

1.0–1.5 < 30 min

1.5–2.0 < 15 min

2.0–2.5 < 4 min

2.5–3.0 < 1 min

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Safety

Neonatal trans-cranial & spinal scanning

TI time Note

0.0–0.7 Unlimited Monitor TIC. MI>0.7 should be used with caution in the presence of

0.7–1.0 < 60 min

1.0–1.5 < 30 min

1.5–2.0 < 15 min

2.0–2.5 < 4 min

2.5–3.0 < 1 min

contrast agents.

Neonatal general and cardiac scanning

TI time Note

0.0–1.0 Unlimited Monitor TIB. MI>0.7 should be used with caution in the presence of

1.0–1.5 < 120 min

1.5–2.0 < 60 min

2.0–2.5 < 15 min

2.5–3.0 < 4 min

contrast agents.

Adult trans-cranial scanning

TI time Note

0.0–1.0 Unlimited Monitor TIC. MI>0.7 should be used with caution in the presence of

1.0–1.5 < 30 min

1.5–2.0 < 15 min

2.0–2.5 < 4 min

2.5–3.0 < 1 min

contrast agents.

General Abdominal, Peripheral Vascular and other scanning (excluding the eye)

TI time Note

0.0–1.0 Unlimited Monitor TIB or TIC if bone closer than 1 cm, TIS if no bone is in the

1.0–1.5 < 120 min

1.5–2.0 < 60 min

2.0–2.5 < 15 min

2.5–3.0 < 4 min

image. MI>0.7 should be used with caution in the presence of contrast agents.

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ALARA

Training

Acoustic output

NOTE: The Vivid S70 / S60 does not monitor the duration of thermal

exposure.

References

• The British Medical Ultrasound Society. Guidelines for the safe use of diagnostic ultrasound equipment.

• American Institute of Ultrasound in Medicine Consensus Report on Potential Bioeffects of Diagnostic Ultrasound.

The maximum possible MI and Ispta on the Vivid S70 / S60 is within the limits set in Track 3 in the FDA 510(k) guide of September 9, 2008, MI < 1.9 and Ispta < 720 mW/cm

Ultrasound procedures should be performed using output levels and exposure times As Low As Reasonably Achievable (ALARA) while acquiring clinical information.

During each ultrasound examination the user is expected to weigh the medical benefit of the diagnostic information that would be obtained against the risk of potentially harmful effects. Once an optimal image is achieved, the need for increasing acoustic output or prolonging the exposure cannot be justified. It is recommended that all users receive proper training in applications before performing them in a clinical setting. Contact the GE sales representative for training assistance.

Safety statement

GE safety statement

Although no harmful biological effects have been demonstrated for ultrasound frequencies, intensities, or exposure times used in examination with the GE system, GE recommends using the lowest acoustic output settings which will produce diagnostically acceptable information.

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Safety

System controls affecting acoustic output

The operator controls that directly affect the acoustic output are discussed in the Acoustic Output Data Tables in the Reference Manual. These tables show the highest possible acoustic intensity for a given mode, obtainable only when the maximum combination of control settings is selected. Most settings result in a much lower output. It is important to note the following:

• The duration of an ultrasound examination is as important as the acoustic output, since patient exposure to output is directly related to the exposure time.

• Better image quality yields faster clinical results, making it possible to complete the relevant ultrasound examination more rapidly. Therefore, any control that improves the quality of the examination can help to reduce patient exposure, even though it may not directly affect acoustic output.

Probe selection

As long as the appropriate application is available, any probe can be used with the knowledge that the intensities fall at, or below, those stated in the Acoustic Output Data Tables. The duration of patient exposure is most likely minimized with the use of a probe that is optimized to provide resolution and focal depth, appropriate to the examination.

Application selection

Selecting the probe and application preset appropriate to a particular ultrasound examination automatically provides acoustic output limits within FDA guidelines for that application. Other parameters which optimize performance for the selected application are also set automatically, and should assist in reducing the patient exposure time. See ‘Connect and disconnect probes’ on page 3-26, for information on selecting probes and application presets.

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Changing imaging modes

Acoustic output depends on the imaging mode selected. The choice of mode (2D, M-Mode, Doppler or Color Flow) determines whether the ultrasound beam is stationary or in motion. This greatly affects the energy absorbed by the tissue.

See ‘Image Optimization’ on page 5-1, for complete information on changing imaging modes.

When operating in a combined mode, such as 2D and M-Mode, the total acoustic output comprises contributions from each individual mode. Depending on the modes in use, either or both output indices may be affected.

The user can override the default settings, but care should be taken to observe the displayed MI and TI values.

Power

It is possible to change the power in all operating modes so that the operator can use the ALARA principle.

Acoustic output

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Safety

OB Exam

Exam Preparation

Prior to an ultrasound examination, the patient should be informed of the clinical indication, specific benefits, potential risks, and alternatives, if any. In addition, if the patient requests information about the exposure time and intensity, it should be provided. Patient access to educational materials regarding ultrasound is strongly encouraged to supplement the information communicated directly to the patient. Furthermore, these examinations should be conducted in a manner and take place in a setting which ensures patient dignity and privacy:

• Prior material knowledge and approval of the presence of nonessential personnel with the number of such personnel kept to a minimum.

• An intent to share with the parents per the physician's judgment, either during the examination or shortly hereafter, the information derived.

• An offer of choice about viewing the fetus.

• An offer of choice about learning the sex of the fetus, if such information becomes available.

Ultrasound examinations performed solely to satisfy the family's desire to know the fetal sex, to view the fetus, or to obtain a picture of the fetus should be discouraged.

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Important safety considerations

WARNING

Important safety considerations

This section includes considerations for the following:

• ‘Patient safety’ on page 2-11

• ‘Personnel and equipment safety’ on page 2-15

• ‘Electromagnetic Compatibility (EMC)’ on page 2-19

• ‘Environmental protection’ on page 2-25

The information contained in this section is intended to familiarize the user with the hazards associated with the use of the system, and to alert them to the extent to which injury and damage may occur if the precautions are not observed.

Users are obligated to familiarize themselves with these safety considerations and to avoid conditions that could result in injury or damage.

Patient safety

Patient identification

The concerns listed in this section can seriously affect the safety of the patient undergoing a diagnostic ultrasound examination.

Always include proper identification with all patient data and verify the accuracy of the patient's name and/or identity number when entering such data. Ensure that the correct patient ID is provided on all recorded data and hard copy prints. Identification errors could result in an incorrect diagnosis.

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Safety

CAUTION

Diagnostic information

The images and calculations provided by the system are intended as a diagnostic tool for competent users. They are explicitly not to be regarded as the sole, irrefutable basis for clinical diagnosis. Users are encouraged to study the literature and reach their own professional conclusions regarding the clinical utility of the system.

The system provides calculations (e.g. estimated fetal weight) and charts based on published scientific literature. The selection of the appropriate chart and clinical interpretation of calculations and charts is the sole responsibility of the user. The user must consider contraindications for the use of a calculation or chart as described in the scientific literature. The diagnosis, decision for further examinations, and medical treatment must be performed by qualified personnel following good clinical practice.

The user should be aware of the product specifications and system accuracy and stability limitations. These limitations must be considered before making any decision based on quantitative values. If in doubt, consult the nearest GE Ultrasound Service Office.

Equipment malfunction or incorrect settings can result in measurement errors or failure to detect details in the image. The user must become thoroughly familiar with the operation of the system in order to optimize its performance and to recognize possible malfunctions. Application training is available through the sales representative.

Be certain to ensure the privacy of patient information.

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Mechanical hazards

WARNING

CAUTION

WARNING

Important safety considerations

Damaged probes or improper use and manipulation of the transesophageal probe may result in injury or increased risk of infection. Inspect probes frequently for sharp, pointed, or rough surface damage that could cause injury or tear protective barriers (gloves and sheaths). Never use excessive force when manipulating intracavity probes. Become familiar with all instructions and precautions provided with special purpose probes.

Observe probe immersion levels (see Figure 13-5 on page 13-21).

Inspect probes for sharp edges or rough surfaces that could injure sensitive tissue.

DO NOT bend or pull the cable forcefully, to avoid mechanical shock or impact to the probe.

Ultrasound transducers are sensitive instruments which can easily be damaged by rough handling. Take extra care not to drop transducers and avoid contact with sharp or abrasive surfaces. A damaged housing, lens, or cable can result in patient injury or serious impairment of operation.

Transesophageal probe safety

Never use excessive force when manipulating intracavity probes. Become familiar with all instructions and precautions provided with special purpose probes.

Electrical Hazard

A damaged probe may increase the risk of electric shock if conductive solutions come in contact with internal live pads. Inspect probes often for cracks or openings in the housing and holes in and around the acoustic lens, or other damage that could allow moisture to enter. Become familiar with the probe's use and care precautions outlined in ‘Probes’ on page 13-1.

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Safety

CAUTION

WARNING

CAUTION

Ultrasound can produce harmful effects in tissue and potentially result in patient injury. Always minimize exposure time and keep ultrasound levels low when there is no medical benefit. Use the principle of ALARA (As Low As Reasonably Achievable), increasing output only when needed to obtain diagnostic image quality. Observe the acoustic output display and be familiar with all controls affecting the output level. See the Bioeffects section of the Acoustic Output chapter in the Advanced Reference Manual for more information.

The system and Electrosurgical units

This equipment provides no special means of protection from high frequency (HF) burns that may result from using an electrosurgical unit (ESU). To reduce the risk of HF burns, avoid contact between the patient and ultrasound transducer or ECG electrodes while operating the ESU. Where contact cannot be avoided, as in the case of TEE monitoring during surgery, make sure the transducer or ECG electrodes are not located between the ESU active and dispersive electrodes and keep the ESU cables away from the transducer or ECG cables

Defibrillation

Remove any sensors on the patient other than the ECG before defibrillation.

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Personnel and equipment safety

CAUTION

WARNING

The hazards listed below can seriously affect the safety of personnel and equipment during a diagnostic ultrasound examination.

General hazard

Do not use this equipment if a safety problem is known to exist. Have the system repaired and performance verified by qualified service personnel before returning to use.

Only approved and recommended peripherals and accessories should be used.

All peripherals and accessories must be securely mounted to the Vivid S70 / S60.

Explosion hazard

Important safety considerations

Electrical hazard

Never operate the equipment in the presence of flammable or explosive liquids, vapors, or gases. Malfunctions in the system or sparks generated by fan motors can electrically ignite these substances. Operators should be aware of the following points to prevent such explosion hazards.

• If flammable substances are detected in the environment, do not plug in or turn on the system.

• If flammable substances are detected after the system has been turned on, do not attempt to turn off the system, or to unplug it.

• If flammable substances are detected, evacuate and ventilate the area before turning off the system.

The internal circuits of the system use high voltages, capable of causing serious injury or death by electrical shock.

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Safety

CAUTION

NOTE: Any rest energy within our scanners or their components will be

To avoid injury

Moving hazard

below 60 V DC or 2 mJ.

• Do not remove the system's protective covers. No user-serviceable parts are inside. If servicing is required, contact qualified technical personnel.

• Connect the attachment plug to a hospital-grade grounding outlet to ensure adequate grounding.

• Do not place liquids on or above the system. Conductive fluids seeping into the active circuit components may cause short circuiting, which could result in an electrical fire.

• An electrical hazard may exist if any light, monitor, or visual indicator remains on after the system is turned off.

Fuses blown within 36 hours of being replaced may indicate a malfunctioning electrical circuit within the system. In this event, the system must be checked by GE Ultrasound service personnel. No attempt should be made to replace the fuses with others of a higher rating.

The ultrasound system weighs approximately 75 Kg (165 lb.).

Special care must be used to avoid injury when moving or transporting the system.

• Always be sure the pathway is clear.

• Limit the speed of movement to a careful walk.

• Use at least two people when moving the system on inclines.

Ensure that the system is well prepared before transporting. Refer to ‘Moving and transporting the system’ on page 3-48 for more information.

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Biological hazard

CAUTION

Pacemaker hazard

Important safety considerations

For patient and personnel safety, beware of biological hazards while performing transesophageal procedures. To avoid the risk of disease transmission:

• Use protective barriers (gloves and probe sheaths) whenever necessary. Follow sterile procedures as required.

• Thoroughly clean and disinfect probes after each patient examination. Refer to Chapter ‘Probes’ on page 13-1, for probe use and care instructions.

• Reusable accessories should be cleaned and disinfected or sterilized as stated by the manufacturer, after each patient.

• Follow all in-house infection control policies as they apply to personnel and equipment.

Electrical safety

Device classifications

The possibility of the system interfering with pacemakers is minimal. However, as this system generates high frequency electrical signals, the operator should be aware of the potential hazard this could cause.

See ‘Classifications’ on page i-3 for more information.

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Safety

CAUTION

Peripheral devices

Use only GE Healthcare approved internal equipment when replacing an internal

peripheral.

External

related IEC/EN standards for safety. The electrical medical systems conformance to IEC/EN60601-1 Clause 16 must be verified.

All non-medical electrical equipment must be kept outside of the patient environment, as defined in IEC/EN60601-1, unless it is equipped with additional protective earth or extra separating transformer. Commercial devices such as laser cameras, printers, VCRs and external monitors, usually exceed allowable leakage current limits per IEC/EN60601-1 and, when plugged into separate AC outlets, are in violation of patient safety standards. Suitable electrical isolation of such external AC outlets, or providing the device with extra protective earth, will be required in order to meet IEC/EN60601-1 standards for electrical leakage currents.

Internally connected peripheral devices

The system, together with peripheral devices, such as video printer, meets ANSI AAMI ES60601-1 and IEC/EN 60601-1 standards for electrical isolation and safety. These standards are applicable only when the specified peripheral devices are plugged into the AC outlets provided on the system.

External Connection of other peripheral devices

peripheral equipment must be in compliance with

External devices can be used only if CE marked and in compliance with related IEC or ISO Safety standards. Conformance to IEC/EN60601-1 Clause 16 requirements for Medical Electrical systems must be verified.

Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC or ISO Safety standards (e.g. IEC/EN60950-1 for data processing equipment or IEC/EN60601-1 for medical equipment). Furthermore all complete configurations shall comply with the requirements for Medical Electrical systems of IEC/EN60601-1. Anybody connecting additional equipment to the signal input part or signal output part of the ultrasound system configures a medical electrical system, and is therefore responsible that the system complies with the requirements of the IEC/EN60601-1 Clause 16. If in doubt, consult the technical service department or your local GE representative.

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Important safety considerations

WARNING

CAUTION

Any devices or cables, other than those sold with the ultrasound system, connected to the Peripheral /accessory connector panel or to an USB port on the system may result in an increase of the electromagnetic emission from the system, or a decrease of the electromagnetic immunity of the system.

When using peripheral device, observe all warnings and cautions given in peripheral operator manuals.

Allergic reactions to latex-containing medical devices

Contact with natural rubber latex may cause a severe anaphylactic reaction in persons sensitive to the natural latex protein. Sensitive users and patients must avoid contact with these items.

Due to reports of severe allergic reactions to medical devices containing latex (natural rubber), the FDA advises healthcare professionals to identify latex-sensitive patients, and be prepared to treat allergic reactions promptly. Latex is a component of many medical devices, including surgical and examination gloves, catheters, incubation tubes, anesthesia masks, and dental dams. Patient reaction to latex has ranged from contact urticaria to systemic anaphylaxis.

For more details regarding allergic reaction to latex, refer to FDA Medical Alert MDA91-1, March 29.

Electromagnetic Compatibility (EMC)

NOTE: This system carries the CE mark. It complies with regulatory

requirements of the European Directive 93/42/EEC concerning medical devices. It also complies with emission limits for a Group 1, Class A Medical Device as stated in EN 60601-1-2 (IEC 60601-1-2).

NOTE: The emissions characteristics of this equipment make it suitable

for use in industrial areas and hospitals, e.g. professional healthcare environment (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services. The user might need

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Safety

to take mitigation measures, such as relocating or re-orienting the equipment.

Electrical medical equipment requires special precautions regarding EMC and must be installed and implemented according to the EMC information provided in this manual.

AII types of electronic equipment may characteristically cause electromagnetic interference with other equipment, transmitted either through air or connecting cables. The term Electromagnetic Compatibility (EMC) indicates the capability of the equipment to curb electromagnetic influence from other equipment, while at the same time not affecting other equipment with similar electromagnetic radiation.

Radiated or conducted electromagnetic signals can cause distortion, degradation, or artifacts in the ultrasound image which may impair the ultrasound system’s essential performance (see page 2-25).

There is no guarantee that interference will not occur in a particular installation. If this equipment is found to cause or respond to interference, attempt to correct the problem by one or more of the following measures:

• Re-orient or re-locate the affected device.

• Increase the separation between the system and the affected device.

• Power the equipment from a source other than that of the affected device.

• Consult your service representative for further suggestions.

The manufacturer is not responsible for any interference or response caused by the use of interconnecting cables other than those recommended or by unauthorized changes or modifications to this system. Unauthorized changes or modifications could void the user's authority to operate the equipment.

To comply with the regulations on electromagnetic interference, all interconnecting cables to peripheral devices must be shielded and properly grounded. Use of cables not properly shielded and grounded may result in the equipment causing or responding to radio frequency interference, in violation of the European Union Medical Device Directive and FCC regulations.

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Interference caution

CAUTION

WARNING

Important safety considerations

Use of devices that transmit radio waves near the system could cause it to malfunction.

Devices which intrinsically transmit radio waves, such as cellular phones, radio transceivers, mobile radio transmitters, radio-controlled toys, etc., should preferably not be operated near the system.

Medical staff in charge of the system are required to instruct technicians, patients, and other people who may be around the system to fully comply with the above recommendations.

Any electrical device can unintentionally emit electromagnetic waves. However, minimum device separation distances cannot be calculated for such unspecified radiation. When the ultrasound system is used adjacent to or in close proximity to other equipment the user should be attentive to unexpected device behavior which may be caused by such radiation.

The ultrasound system is intended for use in the electromagnetic environment specified in the tables below.

The user of the ultrasound system should ensure that the device is used in such an environment.

The use of accessories, transducers and cables other than those specified, with the exception of transducers and cables sold by the manufacturer of the Vivid S70 / S60 as replacement parts for internal components, may result in increased electromagnetic emissions or decreased electromagnetic immunity of the Vivid S70 / S60.

The use of the accessory, transducer or cable with Vivid S70 / S60 other than those specified may result in increased emissions or decreased immunity of the Vivid S70 / S60.

The Vivid S70 / S60 should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the Vivid S70 / S60 should be observed to verify normal operation in the configuration in which it will be used.

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Safety

WARNING

Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Vivid S70 / S60 series system, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

Electromagnetic emissions

The Vivid S70 / S60 is intended for use in the electromagnetic environment specified below. The customer or the user of the Vivid S70 / S60 should ensure that it is used in such an environment.

Guidance and manufacturer’s declaration – electromagnetic emissions.

Emissions test Compliance Electromagnetic environment - guidance

RF emission CISPR 11

RF emission CISPR 11 EN55011

Harmonic emission IEC 61000-3-2

Voltage fluctuations/flicker emissions IEC 61000-3-3

Group 1 The ultrasound system uses RF energy only for its

Class A This system is suitable for use in all establishments,

Class A

Complies

Electromagnetic immunity

The Vivid S70 / S60 is intended for use in the electromagnetic environment specified below. The customer or the user of the Vivid S70 / S60 should ensure that it is used in such an environment,

internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

other than domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes, provided the following warning is heeded: Warning: This system is intended for use by healthcare professionals only. This system may cause radio interference or disrupt the operation of nearby equipment. It may be necessary to take mitigating measures, such as re-orienting or relocating the system or shielding the location.

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Important safety considerations

Guidance and manufacturer’s decleration - electromagnetic immunity.

IEC 60601-1-2 test

Immunity test

level

Compliance level

Electromagnetic

environment -

guidance

Electrostatic discharge (ESD)

IEC 61000-4-2

Electrical transients/ bursts

IEC 61000-4-4

Surge

IEC 61000-4-5

Voltage dips, short interruptions, and voltage variations on power supply input lines

IEC 61000-4-11

±8 kV contact

±15 kV air (max)

±2 kV for power-supply lines

±1 kV for input/output lines 100 kHz Repetition Frequency

±1 kV line(s) to line(s)

±2 kV line(s) to earth 0, 90, 180, 270 phase angles

; 0,5 cycle

0 % U

At 0°, 45°, 90°, 135°, 180°, 225°, 270°, and 315°

; 1 cycle

0 % U

; 25/30 cycles

70% U

Single phase: at 0°

; 250/300 cycles

0 % U

±8 kV contact

±15 kV air (max)

±2 kV for power-supply lines

±1 kV for input/output lines 100 kHz Repetition Frequency

±1 kV line(s) to line(s)

±2 kV line(s) to earth 0, 90, 180, 270 phase angles

Compliance for all test levels.

Controlled shutdown with return to pre-disturbance condition after operator‘s intervention. (Power-on switch)

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Mains power quality should be that of a typical commercial or hospital environment

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment. If the user of the ultrasound system requires continued operation during power mains interruptions, it is recommended that the ultrasound system is powered from an uninterruptible power supply or a battery.

Power frequency (50/60 Hz) magnetic field

IEC 61000-4-8 30 A/m

NOTE: U

is the a. c. mains voltage prior to application of the test level.

50 Hz or 60 Hz

30 A/m 50 and 60Hz

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

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Safety

Guidance and manufacturer’s decleration - electromagnetic immunity.

Immunity test IEC 60601-1-2 test level Compliance level

Conducted RF IEC 61000-4-6

Radiated RF and Proximity fields from RF wireless communications equipment IEC 61000-4-3

3 Vrms 150 kHz to 80 MHz

3 V/m; 80 MHz to 2.7 GHz 80% AM at 1 kHz

385 MHz (18 Hz Pulse Modulation)

450 MHz (FM +/ -5 kHz deviation 1 kHz sine or 18 Hz Pulse Modulation)

710 MHz (217 Hz PM) 9 V/m

745 MHz (217 Hz PM) 9 V/m

780 MHz (217 Hz PM) 9 V/m

810 MHz (18 Hz PM) 28 V/m

870 MHz (18 Hz PM) 28 V/m

930 MHz (18 Hz PM) 28 V/m

1720 MHz (217 Hz PM) 28 V/m

1845 MHz (217 Hz PM) 28 V/m

1970 MHz (217 Hz PM) 28 V/m

2450 MHz (217 Hz PM) 28 V/m

3 Vrms 150 kHz to 80 MHz

3 V/m; 80 MHz to 2.7 GHz 80% AM at 1 kHz

27 V/m

28 V/m

5240 MHz (217 Hz PM) 9 V/m

5500 MHz (217 Hz PM) 9 V/m

5785 MHz (217 Hz PM) 9 V/m

NOTE: Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

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Essential performance

The essential performance of the ultrasound system is:

• the ability to display physiological images as input for diagnosis by trained physician.

• the ability to display physiological traces as aid for diagnosis by trained physician.

• the ability to display quantified data as input for diagnosis by trained physician.

• the display of ultrasound indexes as aid for safe use of the system.

• the display of probe surface temperature as aid for safe use of the system (Probe dependent).

Environmental protection

System disposal

Please follow the disassembly and part disposal procedure attached inside the system. To access to the procedure, remove the right side panel by unscrewing the two screws on the lower part.

Important safety considerations

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Safety

0459

Symbols

Device labels

The following table describes the purpose and location of safety labels and other important information provided on the equipment.

Label Purpose Location

Identification Plate Manufacturer's name and address

Model Device Listing/Certification Labels

On/off button

Warning: System shutdown using the On/Off button does not disconnect the ultrasound system from mains voltage. For disconnecting the

ultrasound system from mains voltage after system shutdown, please set the circuit breaker close to the mains inlet to OFF as described on page 3-23.

Equipment Type BF, in which protection against electric shock does not rely on basic insulation only. Provides additional safety precautions such as double insulation or reinforced insulation, because there is no provision for protective earthing or reliance upon installation conditions.

Defibrillator-proof Type CF equipment. ECG

Standard

Rear N/A- by GE

Healthcare

Control panel IEC 60417-5010

Probes / Rear of system

connector

IEC 60417-5333

IEC 60417-5336

Indicates that the product is in compliance with all relevant European Directives and under surveillance by Notified Body 0459.

Rear of system

N/A- by certification body

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Device labels

Label Purpose Location

For USA only: Caution: Federal law restricts this device to sale by or on the order of a physician.

TUV SÜD Classification Label

Mark name: "Eurasian Conformity" mark; the single conformity mark for circulation of products on the markets of memberstates of Customs Union. Mark meaning: This product passed all conformity assessment (approval) procedures that correspond to the requirements of applicable technical reguations of the Customs Union.

GOST-R Mark: per Law of the Russian Federation No. 184-FZ.

Non-ionizing electromagnetic radiation. Rear of

Rear of system

system

Standard

N/A- by GE Healthcare

N/A- by certification body

IEC 60417-5140

Alternating current Various IEC 60417-5032

Protective earth (ground) Internal IEC 60417-5019

Equipotentiality: Indicates terminal to be used for connecting equipotential conductors when interconnecting (grounding) with other equipment as described in IEC60601-1.

Follow instructions for use. Read and understand all instructions in the User's Manual before attempting to use the ultrasound system.

Symbol indicating that the Instructions for Use are supplied in electronic form.

CAUTION - Dangerous voltage: Used to indicate electric shock hazards.

Rear of system

IEC 60417-5021

ISO 7010-M002

ISO 7000-1641

ISO 7010-W012

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Safety

Label Purpose Location

Attention - Consult accompanying documents: Alerts the user to refer to the user documentation when complete information cannot be provided on the label.

The system is not designed for use with flammable anesthetic gases.

CAUTION - Do not push the system sideways when casters are in break position. Instability may occur.

DO NOT place objects on the surface of the rear of the main display while folded.

This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Please contact the manufacturer or other authorized disposal company to decommission your equipment. The disassembly and parts disposition procedure is located on the card cage front cover. To access to the procedure, remove the right side panel.

Various ISO 7010-W001

Rear of system

Top console (both sides)

Display rear panel

Rear of system

Standard

N/A- by GE Healthcare

ISO 7010-P017

ISO 7010-P012

EN 50419

System weight Rear of

Date of manufacture: The date could be a year, year and month, or year, month and day, as appropriate. See ISO 8601 for date formats.

Manufacturer name and address Rear of

Serial number Rear of

Brand and model identifier Rear of

Unique Device Identification (UDI). Every system has a unique marking for identification. Scan or enter the UDI information into the patient health record as required by governing laws.

Device part number identifier Rear of

system

Rear of system

system

Rear of system

system

N/A- by GE Healthcare

ISO 7000-2497

ISO 7000-3082

ISO 7000-2498

ISO 7000-2493

N/A- by GE Healthcare

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Device labels

Label Purpose Location

Assembled in XXXXX (XXXXX represents the country name)

Identify the Customs Country of Origin of the materials.

To indicate the acceptable upper and lower limits of atmospheric pressure for transport and storage.

To identify the temperature limits, for example on transport packaging to indicate limits within which the package has to be kept and handled. The temperature values may be shown adjacent to the symbol.

To indicate the acceptable upper and lower limits of relative humidity for transport and storage.

On transport packaging. To indicate that the items are not to be vertically stacked.

On transport packaging. To indicate the correct upright position.

Rear of system

Package labeling

Standard

N/A- by GE Healthcare

ISO 7000-2621

ISO 7000-0632

ISO 7000-2620

ISO 7000-2402

ISO 7000-0623

On transport packaging. To indicate that the content of the package is fragile and that the package must be handled with care.

On transport packaging. To indicate that the the package must be handled with care.

On transport packaging. To indicate that the package must be kept in dry conditions.

Package labeling

ISO 7000-0621

N/A

ISO 7000-0626

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Safety

For China only

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Device labels

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Safety

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Chapter 3

Prepare the System for Use

Describes the site requirements, system overview, powering on the system, system positioning/ transporting, operator controls, probes, and adjusting the main display.

‘Site requirements’ on page 3-2 ‘System Overview’ on page 3-9 ‘Switching On/Off’ on page 3-23 ‘Connect and disconnect probes’ on page 3-26 ‘The Scanning screen’ on page 3-32. ‘Control panel’ on page 3-35. ‘Main display adjustment’ on page 3-44. ‘Moving and transporting the system’ on page 3-48.

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WARNING

Only qualified physicians or ultrasound sonographers should perform scans of patients for medical diagnostic reasons. Request training, if needed. Ensure that unauthorized personnel do not tamper with the system.

Service representatives authorized by GE Ultrasound will unpack and install the system. Do not attempt to install the system alone.

All the warnings in Chapter ‘Safety’ on page 2-1, should be read and understood before operating the system.

Site requirements

Power requirements

To carry out regular preventative maintenance refer to Chapter ‘System Care and Maintenance’ on page 15-2.

Maintain a clean environment. Turn off the circuit breaker before cleaning the system. Refer to ‘System Care and Maintenance’ on page 15-2 for cleaning instructions.

The ultrasound system must operate within the proper environment and in accordance with the requirements described in this section. Before using the system, ensure that the requirements are met.

Optimal operation of the system can be obtained by implementing the following requirements:

The ultrasound system uses a separate power outlet for 100– 240 VAC, 50/60 Hz.

Operating the system with the wrong voltage range causes damages, voiding the factory warranty.

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Site requirements

Operating Environment

Ensure that there is sufficient air flow around the ultrasound system when installed or operated.

Environmental requirements

The ultrasound system requires constant maintenance of its operational environment. Different temperature and humidity requirements are specified for operation, storage and transportation.

Requirement Tempe rature Humidity Air Pressure

Operational 10–35 °C 30–85% 700–1060 hPa

Storage -20–60 °C 10–95% 700–1060 hPa

Transport -20–60 °C 10–95% 700–1060 hPa

NOTE: System may be operated at an altitude of up to 3000 meters.

Electromagnetic interferences

The ultrasound system is approved for use in hospitals, clinics, and other environmentally qualified facilities, in terms of the prevention of radio wave interference. Operation of the system in an inappropriate environment can cause electronic interference to radios and television sets situated near the medical equipment.

Ensure that the system is protected from electromagnetic interferences as follows:

• Operate the system at least 4.5 meters (15 feet) away from equipment that emits strong electromagnetic radiation.

• Shield the system when operating it in the vicinity of radio broadcasting equipment, if necessary.

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WARNING

Connecting the system

A GE-qualified person should perform the initial system installation.

Connecting the ultrasound system involves preliminary checks of the power cord, voltage level, and compliance with electrical safety requirements.

Use only power supply cords, cables, and plugs provided by or designated by GE.

Ensure that the power cord and plug are intact and that the power plug is the proper hospital-grade type (where required).

The system should be connected to a fixed power socket which has the protective grounding connector. Never use an extension cord or adapter plug.

Failure to provide an adequate earth circuit can cause electrical shock, resulting in serious injury.

Connection of additional protective earth conductors or potential equalization conductors is not necessary in most cases and is only recommended for situations involving multiple equipment in a high-risk patient environment to provide assurance that all equipment is at the same potential and operates within acceptable leakage current limits. An example of a high-risk patient would be a special procedure during which the patient has an accessible conductive path to the heart such as exposed cardiac pacing leads.

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Voltage level check

WARNING

Site requirements

Check the rating label on the rear side of the system (see Figure 3-1).

Check the voltage range indicated on the label:

• 100–240 VAC, 50/60 Hz, 500 VA At 110 V: 6.4 A At 115 V: 6.0 A At 230 V: 3.0 A

Figure 3-1. The rating label location

If the mains supply is not within the specified range, do not connect the system to the power source. Contact your local distributor or the appropriate support resource.

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WARNING

Connecting to the electrical outlet

POWER OUTAGE MAY OCCUR. The ultrasound system requires a dedicated single branch circuit. To avoid circuit overload and possible loss of critical care equipment, make sure you DO NOT have other equipment operating on the same circuit.

The system’s power must be supplied from a separate, properly rated outlet to avoid risk of fire. Refer to ‘Power requirements’ on page 3-2 for rating information.

The power cord should not, under any circumstances, be altered to a configuration rated less than that specified for the current.

Do not use an extension cord or adapter plug.

1. Ensure that the wall outlet is of appropriate type, and that the power switch is turned off.

2. Uncoil the power cable, allowing sufficient slack so that the system can be moved slightly.

3. Attach the power plug to the system and secure it in place by using the retaining clamp.

4. Secure the power plug to the wall outlet.

1. Ground socket

2. Retaining clamp for power plug

3. Circuit breaker

Figure 3-2. Power plug

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Site requirements

CAUTION

WARNING

Ensure that the retaining clamp for the power plug is fixed firmly.

Use caution to ensure that the power cable does not disconnect during system use. If the system is accidentally unplugged and the optional battery is not installed, data may be lost.

To avoid risk of fire, the system power must be supplied from a separate, properly rated outlet.

Under no circumstances should the AC power plug be altered, changed, or adapted to a configuration rated less than specified. Never use an extension cord or adapter plug.

To help ensure grounding reliability, connect to a "hospitalgrade" or "hospital only" grounded power outlet.

1. 100-120 VAC, 1200 VA Plug and Outlet Configuration

2. 220-240 VAC, 1200 VA Plug and Outlet Configuration

Figure 3-3. Example Plug and Outlet Configurations

Battery

The System contains an internal battery (optional), which is not user-accessible. The internal battery acts as a limited alternative power source, which becomes active when the AC power fails or AC cable is abruptly pulled out.

Display turns off and no scanning is possible while in battery mode.

Battery technology

The lithium ion technology used in the system’s battery is significantly less hazardous to the environment than the lithium metal technology used in some other batteries (such as watch

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Prepare the System for Use

batteries). Used batteries should not be placed with common household waste products. Contact local authorities for the location of a chemical waste collection program nearest you.

NOTE: The battery may only be disassembled and re-assembled by an

authorized field-service engineer.

Viewing Current Battery Status

When the system is running, a status icon is displayed in the system Status bar to indicate the current battery status.

Icon Status Description

Table 3-1: Battery status icons

Battery is fully charged (80%-100%)

Battery is partially charged (40%-80%)

Battery is almost empty (10%-40%)

NOTE: The % values mentioned above may fluctuate by up to +/- 3%

points.

View Detailed Battery Status

The status of the battery charge (% charge) appears on the touch panel during Tran sportation mode.

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Getting to know the system

System Overview

1. Main display monitor

2. Touch panel

3. Rear handle

4. Probe and gel holder on both sides of control panel

5. Pull-out alphanumeric Keyboard (option)

6. Front handle

7. Up/down "Flex-Fit" arm

8. Probe connectors (DLP type)

9. Probe-cable management tray (removable)

10. Front-wheel with foot-break

11. Probe connector (RS type for TEE probe)

12. ECG cable connector

13. Doppler Pencil Probe Connector

14. Probe-cable hooks

15. Up/Down & Left/right swivel release lever

16. Front USB port

17. Control panel

18. Articulated arm for display monitor

Figure 3-4. Vivid S70 / S60 (front)

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1. Main display monitor

2. Touch panel

3. Probe and gel holder on both sides of control panel

4. Rear handle

5. Rear I/O connectors panel

6. System labels

7. Swivel rear wheels

8. Circuit-breaker, power and ground connectors

9. Ventilation port

10. Black and white video printer (optional)

11. CD/DVD drive (option)

12. Doppler speakers

13. Articulated arm for display monitor

Figure 3-5. Vivid S70 / S60 (rear)

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Removable media

CAUTION

Intended use

System Overview

Removable media can be used for the following purposes:

• Long-term image storage: The final destination of the images, after they are moved out of the system harddisk by using the Disk Management feature (see page 10-48).

• Backup of patient database and system configuration presets (see page 10-56)

• Patient archive sneakernet: Copy a set of patient records between a system and EchoPAC Software Only using the Transfer feature (see page 10-40) with removable media.

• DICOM transfer to copy a set of patient records to/from a third party DICOM review station.

• XML export: Exports demographics, measurements, and reporting data from the system to a third party reporting application using removable media (see page 10-40).

• Copy of system configuration presets between two units using the Backup/Restore feature (see page 10-56).

• Save images as JPEG, MPEG, AVI, DICOM, or RawDICOM for review on a regular computer.

Supported removable media

The following removable media are supported:

• CD-R (option)

• DVD-R (option)

• USB Flash card

Archive removable media written from a Vivid S70 / S60 using the 203 software cannot be read by a Vivid S70 / S60 using older software.

NOTE: Depending on the system configuration, USB mass storage may

be disabled on the system. Enabling/disabling of USB mass storage can only be done by users with administrator right s: Sys Admin or GE Admin users (see ‘Local System Users’ on page 12-8). When USB mass storage is disabled, the following icon is shown on the status bar:

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Prepare the System for Use

CAUTION

USB Flash card:

• Use only shielded USB Flash cards that are verified for EMC performance according to EN55011/EN55022. The use of other USB Flash cards may cause interference on the system itself or on other electronic devices.

Recommendation concerning CD and DVD handling

To avoid data loss, never touch the recordable surface of a disk. Handle the disk only by the outer edge. Do not place it face down on a hard surface. Fingerprints or scratches will make the disk unusable. Before usage, verify that the disk surface has no visible scratches. If there are any scratches, do NOT use the disk.

Formatting removable media

To format removable media:

1. Insert the media in the drive.

2. Press Utility/Config on the Touch panel.

3. If required, log on to the system.

4. Select the category Connectivity and select the sheet Tools (Figure 3-6).

Figure 3-6. The Tools sheet

5. Select the removable media from the Media drop-down menu (CD-R, DVD-R or USB device).

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System Overview

CAUTION

NOTE: Select Refresh if the media does not appear on the list.

6. Enter a name for the removable media in the Label field.

NOTE: Only the following characters and signs can be used when

labeling a media: A - Z, a - z, 0 - 9, “_” and “-”. Do not use more than 11 characters or signs. Do not use space.

7. Select Format. A confirmation window is displayed.

The formatting process will erase any data present on the media.

8. Select OK to continue.

9. Wait for the display of the Information window indicating that the formatting process is completed.

10. Select OK.

11. Eject the media as described below.

NOTE: Removable media used during Disk space management,

Backup, Export, or Save as do not need to be formatted in advance as the formatting process is part of these procedures if required.

Ejecting removable media

1. Press Utility/Eject on the Touch panel.

NOTE: Do not eject CD/DVD using the button on the CD/DVD drive.

The Eject device menu is displayed (Figure 3-7).

2. Select the relevant media.

Wait for the display of the Information window indicating that the device can be safely removed before removing the media.

Figure 3-7. The Eject device menu

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CAUTION

Physiological traces

The physiological module consists of two channels: ECG and Respiration. The scanned image that is displayed is synchronized with the ECG and respiration traces. In M-Mode or Doppler, the traces are synchronized to that particular mode's sweep.

Use only GE Healthcare accessories.

Conductive parts of electrodes and associated connectors for applied parts, including neutral electrodes should not contact other conductive parts, including earth.

Simultaneous use of two or more applied parts will cause summation of patient leakage currents.

Heart rate may be adversely affected by cardiac arrhythmias or the operation of cardiac pacemaker pulses.

Figure 3-8. The patient (I/O) connection panel

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ECG/Respiration

System Overview

The ECG cable is a modular cable consisting of two distinct parts:

• The Trunk: A single cable connecting to the system at one end, providing a cable splitter device at the other end (see Figure 3-9).

• The triple color-coded electrode cable: To be inserted in the splitter device. Each electrode cable hooks up to the appropriate stick-on electrode by a color-coded clip type connector.

The color-coding of the electrodes follows one of two standards that are common in different parts of the world. The cable splitter device illustrates the color codes, names, and body locations for the two standard color codes (see Figure 3-9).

AHA (USA) IEC (Europe, Asia, ROW)

1. RA: White

2. LA: Black

3. LL: Red

1. R: Red

2. L: Yellow

3. F: Green

Figure 3-9. The cable splitter device with electrode placement conventions

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CAUTION

To connect the internal ECG

1. Connect the ECG trunk cable to the rectangular socket marked ECG on the patient trace (I/O) panel. The patient trace (I/O) panel is located at the front left of the ultrasound system (see Figure 3-8).

2. Hook up the electrode cables to the electrodes, following the appropriate convention (see Figure 3-9).

Using Physio

The use of respiratory monitoring might interfere with the proper operation of impedance-based rate-responsive pacemakers. When examining a patient with a pacemaker, it is required to turn off the respiratory trace on the system. This will block off the respiratory monitoring signals which might interfere with the pacemaker.

Exception: When using an external respiratory monitor, turning off the respiratory trace on the system WILL NOT block the operation of the external monitor.

Display ECG trace

Figure 3-10. ECG controls

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1. The ECG is displayed by default in all cardiac applications.

NOTE: The ECG button shows/hides the ECG trace. It does not

2. The following controls can be adjusted:

Removing/adding Triggers

In case of a noisy ECG the system could generate an erroneous QRS marker which produces a heart cycle loop in a wrong location. The user can correct this manually by adjusting the actual location of the relevant QRS marker.

System Overview

For all other applications, press the tab Physio on the Touch panel. and press ECG (Figure 3-10).

turn off the ECG.

• Horiz. Sweep: Adjusts the sweep speed stepwise (1, 2,

3, 4, 6, 8, 12, and 16 sec. The default setting is 4 sec.)

• Gain: Adjusts the trace amplitude.

• Position: Moves the trace vertically.

• ECG Lead: Selects the desired lead:

- Lead 1: RA (-) to LA (+) (right, left, or lateral)

- Lead 2: RA (-) to LL (+) (superior inferior)

- Lead 3: LA (-) to LL (+) (superior inferior)

• QRS visible: Show/Hide the QRS marker on the ECG.

To remove a QRS marker on a replayed loop:

1. Press QRS visible to display the QRS markers and identify

2. Press 2D Freeze to stop the cineloop and use the trackball

3. Press Remove Trig.

To add a trigger:

1. Place the small red bar on the place where a QRS marker is

2. Press Add Trig.

3. Press 2D Freeze and store a copy of the cineloop with the

Display respiratory trace

1. Press the Physio tab on the Touch panel.

2. Press Respiratory.

3. The following controls can be adjusted:

any extra QRS marker to be removed.

to place the small red bar in the vicinity of the QRS marker to be removed.

missing.

The new QRS marker is added.

new QRS markers.

The respiratory signal appears in addition to the ECG signal.

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• Lead selection: Select the one that provides a stronger

• Horiz. Sweep: Adjusts the sweep speed.

• Gain: Adjusts the trace amplitude.

• Position: Moves the trace vertically.

signal

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Peripheral/accessory connector panel

WARNING

The Peripheral/accessory connector panel is located at the rear of the system (see Figure 3-11).

System Overview

1. Ethernet LAN connector

2. Insulated USB connector (supporting USB 1.0)

3. Dual USB connector (supporting USB 2.0)

4. DVI display-out connector

Figure 3-11. Peripheral/accessory connector panel

Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC or ISO Safety standards (e.g. IEC/EN 60950 for data processing equipment and IEC/EN 60601-1 for medical equipment). Any person connecting additional equipment to the signal input part or output part of the ultrasound system configures the medical system and is therefore responsible that the system complies with the requirements of the medical electrical systems of IEC/ EN 60601-1 Clause 16. If in doubt, consult the technical service department or your local representative.

Do not touch the conducting parts of the USB or Ethernet cables when connecting equipment to the system.

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WARNING

Any devices or cables, other than those sold with the ultrasound system, connected to the Peripheral /accessory connector panel, or to an USB port on the system may result in an increase in the electromagnetic emission from the system, or a decrease in the electromagnetic immunity of the system.

Socket Signal type Device type Note

Insulated USB Universal serial bus

supporting USB 1.0

USB - Dual socket Universal serial bus

supporting USB 2.0

DVI Digital signals only Digital monitor This is a DVI-I connector, but

Ethernet 1000 Base-TX

Ethernet IEEE 802.3

Printer Printers with external power

supply will connect here

Memory devices Devices without

supply will connect here

there is no analog signal transmission. Only digital monitors can be connected.

Network device

external power

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Wired Footswitch (Option)

CAUTION

You can attach this Footswitch to the system by connecting it to one of the USB port on the rear of the system.

To avoid damage of the cable, keep the cable away from the wheels. Disconnect the Footswitch before moving the system.

System Overview

Figure 3-12. Footswitch and USB Cable

This is a 3-pedal Footswitch. You can configure its functionality from the Config/Imaging/Application (see page 12-22).

The graphic on the bottom of the main screen can be configured to show the functional assignment of the different pedals. See the example in Figure 3-13.

Figure 3-13. Footswitch functional assignment

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CAUTION

When using the Footswitch, DO NOT hold down the footswitch pedal. Press and release the Footswitch pedal. Pushing and holding down the pedal behaves the same way as pushing and holding down a key on the keyboard.

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Switch on the system

1. Switch on the circuit breaker at the rear of the system (see

2. Press the on/off button on the top left of the control panel

Switching On/Off

Figure 3-14).

(see Figure 3-14).

After initialization the default scanning screen is displayed.

1. On/Off switch

2. Control Panel

3. Circuit breaker

Figure 3-14. The Circuit breaker and On/Off button

During the boot-up process the system may require the user to enter a password to operate it. Personal IDs and associated passwords can be configured in the Vivid S70 / S60 (‘Users and Security’ on page 12-8) .

If IDs and passwords have been entered and "Use Auto Logon" is Off (‘Auto logon’ on page 12-11), the Operator Login window appears, requesting for an ID and password when Power up sequence is completed, or when it is required.

NOTE: By factory Login default, the Operator ID is USR and there is no

need to enter a password.

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Prepare the System for Use

Switch off the system

When the ultrasound system is switched off, the system performs an automatic shutdown sequence. It is recommended to perform a full shutdown at least once per week. This will prevent extreme memory fragmentation, which might cause some computer slowdown.

Shutdown

1. Press the on/off button on the top left of the control panel. The Exit dialogue window is displayed.

Figure 3-15. The Exit dialogue window

The system can be switched off into one of the three states:

• Shutdown: the entire system is shut down. Full

shutdown is recommended if the system is not intended to be used for a whole day or longer.

• Standby mode: In Standby mode most of the system is

powered down, but a certain portion of the system remains energized. Standby mode allows a shorter reboot time when the system is used on a daily basis or moved from one place to another.

• Transportation mode: When AC power is interrupted,

the main screen and keyboard are powered down. The touch panel and the rest of the system is still powered by an internal battery. When AC power is resumed, the system will turn ON in less than 5 seconds (‘Using Transportation mode’ on page 3-51).

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Switching On/Off

WARNING

Battery performance may degrade over time and limit the use of transportation mode. In case the battery can not be fully charged, or can not support transportation mode for more than 20 minutes please arrange for service of the battery.

NOTE: In case of total lockup of the system, hold the on/off button

down a few seconds to turn the system off.

2. Select Shutdown. The shutdown process takes a few seconds and is

completed when the color of the on/off button changes from green to amber.

3. Select Standby.

The systems enters Standby mode. Booting up from Standby mode takes less than a minute.

NOTE: After switching off the system, wait at least ten seconds before

turning it on again.

NOTE: Whenever the system is fully shut down or put in Stand by mode,

the system automatically performs "End-Exam" to save all data and images of the current patient into the archiving system.

When switching the system off to move it, follow the additional steps below:

1. Wait until the on/off button has turned amber and set the circuit breaker to OFF.

2. Remove the plug from the mains power socket.

3. Secure the system power cable around the cable storage hooks at the rear of the system.

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Connect and disconnect probes

Connect the probe

Probes can be connected at any time, whether the system is on or off.

The system has two types of probe ports: one RS probe port and three DLP probe ports (Figure 3-16).

1. DLP Probe port

2. RS Probe port

Figure 3-16. Probe ports

1. Before connecting the probe:

• Inspect the probe and the probe cable for any damage.

• Do a visual check of the probe pins and system sockets.

Remove any dust or foam remains from the probe pins.

2. Hold the probe connector vertically with the cable pointing upward.

3. Turn the connector locking handle counterclockwise.

4. Align the connector with the probe port and carefully push into place.

5. Turn the locking handle clockwise to the full vertical position to lock in place.

6. Position the probe cable so that it is not resting on the floor.

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Connect and disconnect probes

CAUTION

WARNING

CAUTION

Do not allow the probe head to hang freely. Impact to the probe head may result in irreparable damage.

Take the following precautions with the probe cables:

• Keep free from the wheels.

• Do not bend.

• Do not cross cables between probes.

Do NOT touch the patient and any of the connectors on the ultrasound system simultaneously, including ultrasound probe connectors.

NOTE: Further information on handling of ICE and TEE probes is

located in the particular user manuals supplied with these probes.

Connect the 6Tc-RS or the 9T-RS TEE probe

Transesophageal probes require a special handling. Refer to the user documentation enclosed with these probes.

The 6Tc-RS and the 9T-RS probes are equipped with a Vivid i connector. To connect these probes to the ultrasound system, use the RS probe port(see Figure 3-16).

To connect a probe (Small connector - type RS)

1. Hold the probe connector vertically with the cable pointing upward.

2. Push the connector locking handle to the right-most position.

3. Align the connector with the probe port and carefully push into place.

4. Push the connector locking handle to the left-most position.

5. Position the probe cable so that it is not resting on the floor.

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CAUTION

WARNING

Figure 3-17. RS Probe Connection Locking Lever

Handle the probes gently while connecting and disconnecting

Do NOT touch the patient and any of the connectors on the ultrasound unit simultaneously, including ultrasound probe connectors.

Activate the probe

When a probe is connected to the system it is automatically detected.

Selecting a probe and an application

1. Press Probe on the control panel. A list of the connected probes and application presets is displayed.

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Connect and disconnect probes

CAUTION

Figure 3-18. Probe selection

2. Select the desired probe application preset to start scanning.

Make sure that the probe and application names displayed on the screen correspond to the actual probe and application selection.

Check that the correct TI category is displayed. TIB must be displayed when a fetal application is selected.

Switching Application Preset using QuickApps

QuickApps provides an easy access to specific imaging settings, such as coronary or contrast imaging, without leaving the selected imaging preset.

QuickApps keeps the current scanning mode and image geometry parameters (such as 2D Depth, 2D Width, Color ROI size and position) as adjusted by the user, while optimizing imaging parameters for that selected scanning situation.

The Vivid S70 / S60 comes with a set of factory QuickApps presets for most supported probes and Application Presets. Factory QuickApps cannot be modified, but user-defined QuickApps presets can be created as needed.

QuickApps can be managed on the fly as described below:

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1. New: To create a new QuickApps preset based on the currently active QuickApps preset or Imaging preset. Press New and name the new QuickApps preset as desired.

2. Reload: Has two different functions:

• If a factory QuickApp is active, Reload will restore the default factory settings.

• If a user-defined QuickApp is active, Reload will restore the most recently saved settings on that

QuickApp.

3. Save: To overwrite the currently active QuickApps preset. It is only possible to use Save when working with a user defined QuickApps preset (Save is not available for factory QuickApps presets).

4. Delete: To delete a user defined QuickApps preset. Press Delete and select the QuickApp that should be eliminated.

Figure 3-19. Manage QuickApps

Deactivate the probe

Press the Freeze key to deactivate the probe. When deactivating the probe, the probe is automatically placed in Standby mode.

Disconnect the probe

Probes can be disconnected at any time. It is recommended that the probe should not be active when being disconnected.

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Connect and disconnect probes

To disconnect a probe (Small connector - type RS):

1. Freeze the image by pressing Freeze.

2. Press the connector locking lever towards the left to unlock

the connector.

3. Pull the probe and connector straight out of the probe port.

4. Carefully slide the probe and connector away from the probe port and around the right side of the keyboard.

5. Ensure the cable is free.

6. Be sure that the probe head is clean before placing the probe in its storage case.

To disconnect a probe (Large connector - type DLP):

1. Rotate the lock handle counter-clockwise to the horizontal position to unlock the connector.

2. Pull the connector straight out of the probe port.

Transporting probes

When transporting a probe a long distance, store it in its carrying case.

Storing probes

It is recommended that all probes be stored in the carrying case provided.

• First place the probe connector into the carrying case.

• Carefully wind the cable into the carrying case.

• Carefully place the probe head into the carrying case. DO

NOT use excessive force or impact the probe face.

Intra Cardiac Ultrasound Catheters

See ‘Intracardiac Ultrasound Catheters’ on page 13-11 for information.

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The Scanning screen

1. Title bar

- Current patient data

- Institution

- Operator ID

-Probe

- Application

- Mechanical & Thermal Index

2. Measurement result table

3. Depth scale

4. Physiological traces, ECG, Phono, Resp

5. Probe orientation marker

6. Measurement

7. Scanplane indicator (TEE probe/4D probe)

8. Greyscale/Color bar

9. Parameter window

10. Clipboard

11. Prompt/Status information

12. - Trackball assignment

- Footswitch pedal assignments

- TEE probe button assignments

13. - Caps lock on/off

- Access to service platform

- Network status

14. Frame counter and timer

15. Probe surface temperature indicator (only appears when a TEE probe is selected)

16. Current, real-time display of Heart-rate, Date and time

Figure 3-20. The scanning screen (composite)

The scanning screen is divided in several areas as follows:

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The Title bar

NOTE: The patient information displayed on the Title bar is configurable

Patient Information

Institution name

Operator ID

The Scanning screen

(‘Global imaging settings’ on page 12-17).

From the left:

Displays the information that uniquely identifies the patient, such as patient name, identification number and birth date. This information is entered in the New patient window (‘Creating a new patient record’ on page 4-2).

The institution name is entered from the configuration package (‘General system settings’ on page 12-4).

Identification code of the operator (‘Users and Security’ on page 12-8).

Date and time

Displays the current date and time or for a retrieved image, the date and time at which it was stored.

Probe and Application

Displays the currently selected probe and application or for retrieved image the probe and application that were used (‘Selecting a probe and an application’ on page 3-28).

Live scanning related information

Displays, if available, the current values for

• Mechanical Index (MI), for the current active image

• Thermal Index (TI), for the current active image

• Probe temperature (for TEE probe)

• Heart rate (HR)

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Archive Information

Displays the currently selected patient and image archives.

Parameters window

Displays scan mode or application specific parameters. In scanning mode the parameters for the active mode are highlighted. This window also displays zoom information, stress template, and image groups in image browser.

Clipboard

Displays the thumbnail images representing the acquired data during the current examination.

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Control Panel overview

Control panel

1. Touch panel with adjustment Softkey rotaries (see page 3-42)

2. On/Off button (see page 3-23)

3. Active mode gain

4. TGC Screen activation

5. 2D Gain

6. Auto (Auto-tissue, ASO)

7. Cursor

8. Scan mode selection

9. Trackball and related buttons (see page 3-37)

10. 4D & Multi D controls (Vivid S70 only)

11. Loudspeaker volume control

12. Flex - programmable button

13. Zoom

14. Clear

15. Depth

16. Print, capture

17. Freeze, 2D Freeze

18. Measurement, Caliper

19. Store

Figure 3-21. The control panel

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Key illumination

The keys on the control panel are illuminated according to their availability:

• Illumination in green: The key function is currently active.

• Illumination in yellow: The key function is available (but not active) in the current state of the system.

• No illumination: The key is not available in the current state of the system.

Adjust the Control Panel

The system Control panel can be freely adjusted to swivel or move up/down. There are two brake handles located under the control panel.

To swivel the control panel left or right

1. Pull and hold the left brake handle, located under the control panel.

The control panel can now be freely rotated left or right.

2. When reaching the desired swivel angle, release the swivel-brake handle.

The control panel will remain at the set angle.

NOTE: The main display will swivel together with the control-panel. In

addition the main display may be swiveled independently of the control-panel.

To move the control panel up or down

1. Pull and hold the right-hand handle, located under the control panel.

The control panel can now be freely adjusted up or down.

2. When reaching the desired height, release the height-adjust handle.

The control panel will remain at the set height.

NOTE: When the control panel is lowered it moves towards the

operator. When panel is raised it also moves away from the operator.

NOTE: When preparing the system to be moved, pull the left handle and

bring the control panel to a center position. Swivel it slightly till a locking click is heard.

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GE Vivid S60 DNA Extraction Module Catalog #12016408EDU Instruction Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Vivid™ S70 / Vivid S60

Table of Contents

Introduction

Overview

Contact Information

Safety

Safety Precautions

Owner responsibility

Acoustic output

Important safety considerations

Device labels

Prepare the System for Use

Site requirements

System Overview

Switching On/Off

Connect and disconnect probes

The Scanning screen

Control panel