Vivid S60N and S70N User Manual Rev 06 Dec 2018

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

0123 This manual is a reference for the Vivid S60N and Vivid S70N ultrasound systems, hereafter listed as Vivid S60N / S70N. It applies to all revisions of the 201 software for the Vivid S60N / S70N ultrasound system. All information provided in this manual is relevant for the two systems unless otherwise specified.

GE Vingmed Ultrasound AS Strandpromenaden 45 N-3191 Horten, Norway Tel.: (+47) 3302 1100 Fax: (+47) 3302 1350

Revision History Reason for change

REV

DATE (YYYY-MM-DD)

REASON FOR CHANGE

Rev. 01

2015-03-13

Initial release.

Rev. 02

2015-09-17

CE 0123 release.

Rev. 03

2016-05-10

Added probes 11L-D, C2-9-D, C3-10-D, P6D.

Rev. 04

2017-04-25

Updated cleaning instructions.

Rev. 05

2018-03-23

Device labels.

Rev. 06

2018-12-19

Contact Information Electromagnetic Compatibility (EMC) Probes System Care and Maintenance

List of Effective Pages PAGE NUMBER All pages

REV Rev. 06

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.

Vivid S60N / S70N – User Manual FR092030-06

i-1

Regulatory Requirements

Conformance Standards The GE 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. Ignoring this advice may compromise the regulatory approvals obtained for the product. This product complies with the following regulatory requirements: Standard/Directive

Scope

93/42/EEC

Medical Devices Directive (MDD)

2002/96/EC

Waste Electrical and Electronic Equipment (WEEE)

2011/65/EU

Directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment (ROHS).

IEC/EN 60601-1

Medical Electrical Equipment, Part 1; General Requirements for Safety

IEC/EN 60601-2-37

Medical electrical equipment - Part 2-37. Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

IEC/EN 60601-1-2

Medical electrical equipment - Part 1-2: General requirements for safety and essential performance - Collateral standard: Electromagnetic disturbances Requirements and tests

IEC/EN 60601-1-4

Medical electrical equipment - Part 1-4: General requirements for safety Collateral standard: Programmable electrical medical systems

IEC/EN 60601-1-6

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability

IEC/EN 62304

Medical device software - Software life-cycle processes

IEC/EN 62366

Medical devices -Application of usability engineering to medical devices

CAN/CSA-C22.2 No. 60601-1:08

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.

NEMA Standards Publication UD 2

Acoustic Output Measurement Standard For Diagnostic Ultrasound Equipment

NEMA Standards Publication UD 3

Standard for real-time display of thermal and mechanical acoustic output indices on diagnostic ultrasound equipment.

i-2

Vivid S60N / S70N – User Manual FR092030-06

Certifications •

GE Vingmed Ultrasound AS is ISO 13485 certified.

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 later in this chapter (‘Device labels’ on page 2-27).

•

First CE Marked in 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.

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.

Class I Equipment 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.

Vivid S60N / S70N – User Manual FR092030-06

i-3

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

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 ®

i-4

Vivid S60N / S70N – User Manual FR092030-06

Table of Contents

Table of Contents

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

Table of Contents Chapter 1 - Introduction Overview Attention - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3 Documentation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3

Conventions used in this manual Principles of operation- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-5 Operator profile - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-5 Indications for Use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-5 Contraindications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-6 Prescription device - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-6 Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-6 Interference caution - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-6

Contact Information Contacting GE Ultrasound - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-7 Manufacturer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-12

Chapter 2 - Safety Introduction Hazard symbols - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-3

Owner responsibility Notice against user modification- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-4

Acoustic output Definition of the acoustic output parameters - - - - - - - - - - - - - - - - - - - - 2-5 Acoustic output and display on the Vivid S60N / S70N - - - - - - - - - - - - - 2-6 ALARA - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-8 Safety statement- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-8 System controls affecting acoustic output - - - - - - - - - - - - - - - - - - - - - - 2-9 OB Exam - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-10

Important safety considerations Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-11

Vivid S60N / S70N – User Manual

FR092030-06

i-5

Table of Contents Patient safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-11 Probe safety- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-12 Personnel and equipment safety - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-16 Electromagnetic Compatibility (EMC) - - - - - - - - - - - - - - - - - - - - - - - - 2-20 Environmental protection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-26

Device labels Symbols- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-27

Chapter 3 - Getting started Introduction Preparing the unit for use Site requirements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-3 Connecting the unit - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-4 Switching On/Off- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-10 Using Transportation mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-13 Control Panel adjustment - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-15 LCD monitor mechanical adjustment - - - - - - - - - - - - - - - - - - - - - - - - 3-15 Connecting and disconnecting probes - - - - - - - - - - - - - - - - - - - - - - - 3-17

Moving and transporting the unit Wheels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-18 Moving the unit - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-18 Transporting the unit - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-20 Reinstalling at a new location- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-20 Preparing Vivid S60N / S70N for scanning - - - - - - - - - - - - - - - - - - - - 3-20 Unit acclimation time - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-21

System description System overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-22 Control panel - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-24 Peripheral/accessory connector panel - - - - - - - - - - - - - - - - - - - - - - - 3-32 Wired Footswitch (Option) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-34 The Scanning screen - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-36 Three-Pedal Footswitch operation - - - - - - - - - - - - - - - - - - - - - - - - - - 3-38 Connecting and disconnecting probes - - - - - - - - - - - - - - - - - - - - - - - 3-38 Adjusting the Display Monitor- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-39

Starting an examination Creating a new patient record - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-41 Selecting an existing patient record - - - - - - - - - - - - - - - - - - - - - - - - - 3-42 Ending an examination - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-42

Chapter 4 - Basic operations Trackball area Touch panel Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-4 The Shortcut bar- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-5 The Tab pages - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-6 The Rotary/Push buttons - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-7

Removable media Intended use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-8

i-6

Vivid S60N / S70N – User Manual

FR092030-06

Table of Contents Supported removable media - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-8 Recommendation concerning CD and DVD handling - - - - - - - - - - - - - - 4-9 Formatting removable media - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-9 Ejecting removable media - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-10

Physiological traces ECG/Respiration- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-12 Using Physio - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-13 Display respiratory trace - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-14

Cineloop Cineloop overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-16

Zoom Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-18 Display zoom - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-18 HR zoom - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-18

Annotations Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-19 To insert an annotation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-19 Editing annotations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-21 To erase text annotations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-22 Bodymark - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-22 Annotation and bodymark configuration - - - - - - - - - - - - - - - - - - - - - - 4-23

Configuration – System and users About system Configuration - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-27 General system settings - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-29 Touch panel configuration - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-31 System users - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-32

Chapter 5 - Scanning Modes 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- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-10

Color Mode Color 2D Mode overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-11 Color M-Mode overview- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-13 Using Color Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-15 Optimizing Color Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-15

PW and CW Doppler PW and CW Doppler overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-17 Using PW/CW Doppler modes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-19 Optimizing PW/CW Doppler modes - - - - - - - - - - - - - - - - - - - - - - - - - 5-19

Tissue Velocity Imaging (TVI) TVI overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-22 Using TVI- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-24

Vivid S60N / S70N – User Manual

FR092030-06

i-7

Table of Contents Optimizing TVI - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-24

Tissue Tracking Tissue Tracking overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-25 Using Tissue Tracking- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-27 Optimizing Tissue Tracking - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-27

Strain rate Strain rate overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-28 Using Strain rate- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-30 Optimizing Strain rate - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-30

Strain Strain overview- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-31 Using Strain - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-33 Optimizing Strain - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-33

Tissue Synchronization Imaging (TSI) TSI overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-34 Using TSI- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-36

Additional scanning features LogiqView - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-38 Compound - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-39 B-Flow - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-39 Blood flow imaging - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-40

Image controls Control panel - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-41 Touch panel and rotaries - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-41

Scan Assist Pro Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-51 Scan Assist Pro overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-51 Setting up Scan Assist Pro - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-53 Using Scan Assist Pro- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-55

Configuration – Imaging Global imaging settings - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-57 Application list configuration- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-59 Delete an application preset- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-60 Generating a new user preset - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-60 6VT-D TEE probe configuration - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-63

Chapter 6 - 4D and Multi-plane Modes 4D-Mode Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-2 4D-Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-3 4D Color Flow mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-12 Flexi-Slice - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-16 Basic operations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-19 Parallel cropping- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-23 Crop Tool- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-23 4D-Mode controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-26

Multi-plane mode Multi-plane mode overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-32

i-8

Vivid S60N / S70N – User Manual

FR092030-06

Table of Contents Using Multi-plane mode- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-36 Bi-plane prepare - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-36 Basic operations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-38 Multi-plane mode controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-40

Chapter 7 - Stress Echo Introduction Selection of a stress test protocol template Image acquisition Starting acquisition - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-4 Continuous capture mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-8

Stress Echo analysis Image selection for analysis- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-15 Wall motion scoring- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-17

Quantitative TVI Stress echo analysis Accessing QTVI Stress analysis tools - - - - - - - - - - - - - - - - - - - - - - - - 7-21 Vpeak measurement - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-21 Tissue Tracking - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-24 Quantitative analysis - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-24 References - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-24

Editing/creating a Stress Echo protocol template Entering the Template editor screen - - - - - - - - - - - - - - - - - - - - - - - - - 7-25 Editing/Creating a template - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-26

Configuration

Chapter 8 - Contrast Imaging Introduction Data acquisition - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-2 Useful link - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-3

Data acquisition Left Ventricular Contrast Imaging - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-4

Chapter 9 - Measurements and analysis Introduction General recommendations about measurements - - - - - - - - - - - - - - - - - 9-4 About Measurement results display - - - - - - - - - - - - - - - - - - - - - - - - - - 9-4

Assign and Measure modality Measure and Assign modality Measurements on volume renderings - - - - - - - - - - - - - - - - - - - - - - - - - 9-9

Measurements on protocol images Advanced cardiac measurements and analysis Event timing measurements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-11 TSI Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-12 Automated Function Imaging - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-18 AutoEF measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-38 Pediatric Z score measurement study - - - - - - - - - - - - - - - - - - - - - - - - 9-43

4D/Multi-plane LV measurements and analysis Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-45

Vivid S60N / S70N – User Manual

FR092030-06

i-9

Table of Contents 4D Automated Left Ventricular Quantification - - - - - - - - - - - - - - - - - - 9-45 Manual left ventricular volume measurements - - - - - - - - - - - - - - - - - - 9-54 TSI surface model- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-59

4D-MV Assessment Starting the 4D MV-Assessment application - - - - - - - - - - - - - - - - - - - 9-61

Advanced vascular measurements and analysis Intima-Media Thickness- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-62 M-Mode Measurements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-66 Doppler measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-67

Pediatric Calculations Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-72 Hip Dysplasia Calculation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-73 Making Hip Dysplasia Measurement- - - - - - - - - - - - - - - - - - - - - - - - - 9-73

OB measurements OB graphs - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-76 OB-Multigestational- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-81 GYN Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-84 B-Mode Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-86 M-Mode Measurements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-89 Doppler Mode Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-89

Measurement package configuration Basic operations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-90 Measurement package configuration - example - - - - - - - - - - - - - - - - - 9-91 User-defined formulas - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-94 Advanced settings - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-101 Normal values - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-107

Measurement result table Minimizing the Measurement result table - - - - - - - - - - - - - - - - - - - - 9-109 Moving the Measurement result table - - - - - - - - - - - - - - - - - - - - - - - 9-109 Deleting measurements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-109

Worksheet Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-110 Using the Worksheet- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-111 OB worksheet- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-112

Chapter 10 - Quantitative Analysis Introduction Q Analysis overview Starting Q Analysis - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-3 Q Analysis screen- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-4

Using Q Analysis Generation of a trace - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-9 Saving/retrieving Q Analysis - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-12 Frame disabling - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-12 Optimization - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-14 Switching modes or traces- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-17 Anatomical M-Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-18

i-10

Vivid S60N / S70N – User Manual

FR092030-06

Table of Contents Chapter 11 - Archiving Introduction The dataflow concept Dataflows available - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-3

Storing images and cineloops Storing an image - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-6 Storing a cineloop - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-6 Saving images and cineloops to a standard format - - - - - - - - - - - - - - 11-8 MPEGVue/eVue - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-10 EZ DICOM CD Viewer- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-13

Retrieving and editing archived information Searching for a patient record - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-15 Editing data in the archive - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-17 Deleting archived information- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-24 Moving examinations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-26

Review images in archive Review the images from a selected examination - - - - - - - - - - - - - - - 11-28 Review images from a selected patient record- - - - - - - - - - - - - - - - - 11-30

Connectivity The dataflow concept - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-35 Dataflow selection- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-38 Scanner connectivity configuration - - - - - - - - - - - - - - - - - - - - - - - - - 11-38

Transfer of patient records/examinations Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-50 Transferring patient records/examinations- - - - - - - - - - - - - - - - - - - - 11-51

Disk management Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-58 Configuring the Disk management function - - - - - - - - - - - - - - - - - - - 11-59 Running the Disk management function - - - - - - - - - - - - - - - - - - - - - 11-61

Data Backup and restore Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-65 Backup procedure- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-65 Restore procedure - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-69

Configuration – Archiving Configuration of the archiving functions- - - - - - - - - - - - - - - - - - - - - - 11-72 TCP/IP configuration - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-74 Dataflow - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-74 Default remote path setting - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-77 XML and MPEG Vue Export configuration- - - - - - - - - - - - - - - - - - - - 11-78 Other - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-80

Chapter 12 - Report Introduction Creating a report Working with the report function To open a report - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-4 To choose another report template - - - - - - - - - - - - - - - - - - - - - - - - - - 12-6

Vivid S60N / S70N – User Manual

FR092030-06

i-11

Table of Contents To change patient information - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-6 Images in the report - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-6 To print a report - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-7 To store a report - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-7 Retrieving an archived report - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-8 Deleting an archived report - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-8

Structured Findings Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-9 Starting Structured Findings- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-10 Using Structured Findings - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-12 Structured Findings configuration - - - - - - - - - - - - - - - - - - - - - - - - - - 12-14

Report designer Accessing the Report designer- - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-24 Report designer overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-25 Designing a report template - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-26 Saving the report template- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-37 To exit the Report designer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-37

Report templates management Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-38 Configuration of the Template selection menu - - - - - - - - - - - - - - - - - 12-39 Export/Import of Report templates - - - - - - - - - - - - - - - - - - - - - - - - - 12-40

Chapter 13 - Probes Probe overview Supported probes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-2 Probes/Applications overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-5 Maximum probe temperature - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-6 Probe orientation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-7 Probe labelling - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-8

Probe Integration Connecting the probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-9 Activating the probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-11 Deactivating the Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-12 Disconnecting the Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-12

Care and Maintenance Planned maintenance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-14 Inspecting the probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-14 Cleaning and disinfecting probes - - - - - - - - - - - - - - - - - - - - - - - - - - 13-15 Coupling gels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-40

Probe safety Electrical hazards - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-41 Mechanical hazards - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-41 Biological hazards- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-42

Biopsy Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-44 Precaution concerning the use of biopsy procedures - - - - - - - - - - - - 13-45 Preparing the Biopsy guide attachment - Convex, Sector and Linear probes 13-45

i-12

Vivid S60N / S70N – User Manual

FR092030-06

Table of Contents Displaying the Guide zone - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-49 Biopsy needle path verification- - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-49 Starting the biopsy procedure - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-50 Cleaning, disinfection and disposal- - - - - - - - - - - - - - - - - - - - - - - - - 13-50

Chapter 14 - Peripherals Introduction Printing Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-3 To print an image - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-3

Printing configuration Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-4 P1 button configuration - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-4 Printer setup- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-5

Chapter 15 - Maintenance System Care and Maintenance Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-2 Expected Service Life Description - - - - - - - - - - - - - - - - - - - - - - - - - - 15-3 Inspecting the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-3 Disinfection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-4 Cleaning the unit- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-4 Cleaning the probes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-8 Prevention of static electricity interference- - - - - - - - - - - - - - - - - - - - - 15-8

System self-test System malfunction- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-9

Software upgrade Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-11 Software download and installation- - - - - - - - - - - - - - - - - - - - - - - - - 15-11 Create an Insite permanent user - - - - - - - - - - - - - - - - - - - - - - - - - - 15-15 Save TCP/IP settings - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-16

Chapter 16 - Appendix Scan Assist Pro Creator Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-2 Protocol export from Vivid S60N / S70N and off scanner installation of the Scan Assist Pro Creator - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-2 Starting Scan Assist Pro Creator - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-4 File handling- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-5 Creating new Protocols - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-6 Saving Protocols- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-7 Views - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-8 Step attributes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-11

Index

Vivid S60N / S70N – User Manual

FR092030-06

i-13

Table of Contents

i-14

Vivid S60N / S70N – User Manual

FR092030-06

Chapter 1 Introduction

This chapter describes: ‘Overview’ on page 1-3 ‘Conventions used in this manual’ on page 1-4 ‘Principles of operation’ on page 1-5 ‘Operator profile’ on page 1-5 ‘Indications for Use’ on page 1-5 ‘Contraindications’ on page 1-6 ‘Contact Information’ on page 1-7

Vivid S60N / S70N – User Manual

FR092030-06

1-1

Introduction The Vivid S60N / S70N ultrasound unit is a high performance digital ultrasound imaging system with total data management. The system provides image generation in 4D (option on Vivid S70N), 2D 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 S60N / S70N unit allows optimal usage of all scanning modes and probe types, throughout the full spectrum of operating frequencies.

1-2

Vivid S60N / S70N – User Manual

FR092030-06

Overview

Overview

Attention Read and understand all instructions in the User's Manual before attempting to use the ultrasound unit. Keep the manual with the equipment at all time. Periodically review the procedures for operation and safety precautions. NOTE:

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

NOTE:

Please note that orders are based on the individually agreed upon specifications and may not contain all features listed in this manual.

NOTE:

All references to standards / regulations and their revisions are valid at the time of publication of the user manual.

Documentation CAUTION

The safety instructions must be reviewed prior to operating the unit.

The Vivid S60N / S70N documentation consists of various manuals: •

The Basic User Manual and Online 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)

•

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.

Vivid S60N / S70N – User Manual

FR092030-06

1-3

Introduction The Vivid S60N / S70N documentation is 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. Safety icons, highlight safety issues as described in ‘Introduction’ on page 2-2. Product icons, indicate product variant features as follows: Indicates that the relevant feature exists in the standard configuration of Vivid S70N and is not available on Vivid S60N.

Indicates that the relevant feature exists as an option of the Vivid S70N and is not available on Vivid S60N.

Indicates that the relevant feature exists as an option on both Vivid S70N and Vivid S60N systems.

Indicates that the relevant feature exists in the standard configuration of Vivid S70N and is available as an option on Vivid S60N.

Indicates that the relevant feature exists in the standard configuration of Vivid S60N and is not available on Vivid S70N.

1-4

Vivid S60N / S70N – User Manual

FR092030-06