Venue Basic User Manual Rev 10 Ver R2.0

Regulatory Requirement Venue GoTM complies with regulatory requirements of the following European Directive 93/42/EEC concerning medical devices.

First CE mark in 2018 This manual is a reference for the Venue Go. It applies to software version 302.67.0 or higher software for the Venue Go ultrasound system.

COMPANY DATA

GE Medical Systems Ultrasound & Primary Care Diagnostics LLC 9900 Innovation Drive Wauwatosa, WI 53226 USA

Revision History Reason for Change

REV

DATE (YYYY/MM/DD)

REASON FOR CHANGE

Rev. 1

2018/09/09

Initial release (DOC2048788)

Rev. 2

2018/10/25

Update system labels

Rev. 3

2018/11/12

Update probe leaning chapter and various small updates.

Rev. 4

2018/12/02

Modify “indications for use” phrasing. Modify Probe-cleaning instructions – Chapter 9

Rev. 5

2019/01/17

Add: Virtual convex. Wireless statements. Demo Cart.

Rev. 6

2019/02/21

Modify information related to battery and ECG cable.

Rev. 7

2019/06/03

Add Table 9-17; Correct some typo mistakes.

Rev. 8

2019/09/10

Correct typo in Table 9-17.

Rev. 9

2020/05/12

Add Simple Cart. Modify CE number. Modify Brazil address.

Rev. 10

2020/06/28

Add comment for L4-12t-RS indication in Canada. Update some internet links

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Please verify that you are using the latest revision of this document. Information pertaining to this document is maintained on ePDM (GE Healthcare 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.

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Venue Go – Basic User Manual Direction 5794842-100 Rev. 10

Regulatory Requirements

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

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

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According to IEC/EN 60601-1,

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•

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Equipment is Class I, Type B with BF Applied Parts.

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Cart console is Class I.

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Continuous Operation

According to CISPR 11, •

Equipment is Group 1, Class A ISM not life supporting Equipment. Equipment is Group 1, Class A not life supporting equipment.

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Cart is Group 1, Class A ISM Equipment.

According to IEC 60529, •

Probe head (immersible portion) and cable are IPX7.

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Probe connector is not waterproof.

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System is Ordinary Equipment (IPX0).

This product complies with the regulatory requirement of the following: •

Council Directive 93/42/EEC concerning medical devices: the CE label affixed to the product testifies compliance to the Directive. The location of the CE marking is shown in the Safety chapter of this manual. Authorized EU Representative GE Medical Systems SCS 283 rue de la Miniere 78530 BUC France

Venue Go – Basic User Manual Direction 5794842-100 Rev. 10

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•

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International Electrotechnical Commission (IEC). •

IEC/EN 60601-1 Medical Electrical Equipment, Part 1 General Requirements for Safety.

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IEC/EN 60601-1-2 Electromagnetic compatibility Requirements and tests.

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IEC 60601-1-6 (Usability), EN 1041 (Information supplied with medical devices)

•

IEC 60601-2-37 Medical electrical equipment. Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment.

International Organization of Standards (ISO) •

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Canadian Standards Association (CSA). •

• • •

ISO 10993-1 Biological evaluation of medical devices. CSA 22.2, 601.1 Medical Electrical Equipment, Part 1 General Requirements for Safety.

ANSI/AAMI ES60601-1 Medical Electrical Equipment, Part 1 General Requirements for Safety. NEMA/AIUM Acoustic Output Display Standard (NEMA UD-3, 2004). Medical Device Good Manufacturing Practice Manual issued by the FDA (Food and Drug Administration, Department of Health, USA).

Certifications • •

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC. is ISO 13485 certified GE Medical Systems Information Technologies - Critikon De Mexico S. de R.L. de C.V. is ISO 13485 certified

Original Documentation •

The original document was written in English.

Country Specific Approval •

JAPAN MHLW Certified Number:

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Importer information

Venue Go – Basic User Manual Direction 5794842-100 Rev. 10

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Table of Contents

Table of Contents

Conformance Standards - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-3 Certifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-4 Original Documentation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-4 Country Specific Approval - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-4 Importer information - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-5

Table of Contents Chapter 1 - Introduction System Overview Documentation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3 Principles of Operation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-4 Indications for Use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-4 Frequency of Use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-5 Operator Profile - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-5 Prescription Device - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-5

Contact Information Contacting GE Ultrasound - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-6 Manufacturer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-10 Factory sites- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-10

Chapter 2 - Safety Owner Responsibility Owner requirements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-2 Notice against user modification- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-2

Safety Precautions Precaution Levels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-3 Hazard Symbols - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-4 Patient Safety- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-5 Equipment and Personnel Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-9 General Caution - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-14 EMC (Electromagnetic Compatibility) - - - - - - - - - - - - - - - - - - - - - - - - 2-16 Patient Environmental Devices- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-27 Acoustic Output - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-28 Federal Communications Commission (FCC) Statement - - - - - - - - - - 2-31 Appendix A: CE Statement & Declaration of Conformity - - - - - - - - - - - 2-32 RoHS Venue Go Hazardous Substances - - - - - - - - - - - - - - - - - - - - - 2-33 Environmental protection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-35

Device Labels Label Locations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-36 Warning Label Locations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-38 Probe Label Explanation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-41

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Table of Contents Battery Label Explanation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-43 Icon description - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-43

Chapter 3 - Preparing the System for use Site Requirements Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-2 Before the system arrives - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-2 Environmental Requirements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-3 Acclimation Time - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-5

Console Overview Main system parts- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-6 System USB Ports - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-7 External drives (USB Flash Drive, USB HDD) - - - - - - - - - - - - - - - - - - - 3-8 Storage areas- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-8 Speakers - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-10 Battery- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-10 Peripheral/Accessory Connection- - - - - - - - - - - - - - - - - - - - - - - - - - - 3-17 Peripherals Connection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-20

System Positioning/Transporting Using various carts - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-26 Adjustment of the system mounted on a Venue Go Simple Cart - - - - - 3-31 Moving the System with the cart- - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-32 Before moving the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-32 When moving the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-33 Transporting the System - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-34 Reinstalling at a new location- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-35

Powering the System Battery Status Indicator - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-41 Connecting the System to AC power - - - - - - - - - - - - - - - - - - - - - - - - 3-41

Adjusting the system’s position on the cart Rotate, tilt, raise and lower the system on the Standard or Demo cart - 3-46 Tilting the system on the Simple Cart - - - - - - - - - - - - - - - - - - - - - - - - 3-46 Adjusting the monitor's Brightness - - - - - - - - - - - - - - - - - - - - - - - - - - 3-47

Probes Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-50 Connecting the Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-50 Cable Handling - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-52 Selecting probes- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-52 Activating the Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-52 Disconnecting the Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-53 Transporting Probes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-54 Storing the Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-54

Operator Controls Touch display - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-55

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Table of Contents Chapter 4 - Performing an Exam Overview Begin a new exam End the previous exam - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-3 Entering patient’s details - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-3 Starting a new exam on an existing patient - - - - - - - - - - - - - - - - - - - - - 4-4 Scanning without entering any patient data - - - - - - - - - - - - - - - - - - - - - 4-4 Selecting the probe and preset- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-5 Selecting probe and preset via main screen shortcuts - - - - - - - - - - - - - 4-7 Scanning - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-7 Storing loops or images- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-7 Making measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-8 Adding findings- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-8 Adding annotations to an image - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-9 Review exam’s stored images - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-9 Review all measurements taken during an exam - - - - - - - - - - - - - - - - - 4-9

Chapter 5 - Optimizing the Image B-Mode Intended Uses - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-2 B-Mode controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-3 Optimizing B-Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-4

Color Flow mode Intended Use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-19 Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-19 Optimizing Color Flow - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-20

M-Mode Intended Use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-28 Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-28 Typical exam protocol - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-28 M-Mode Display & Controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-29

M Color Flow Mode Description- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-32 Activating - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-32 Benefits - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-32 Bioeffects- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-32

Spectral Doppler Intended Use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-33 Spectral Doppler Display - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-33 Typical exam protocol - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-34 PW Doppler Mode Display- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-35 Activating Triplex Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-36 CW Doppler - Steerable Continuous Wave Doppler (CW)- - - - - - - - - - 5-36 Activating CW Doppler - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-36 TDI mode- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-44

ECG (option) Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-46 Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-46

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Table of Contents ECG cable - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-48 ECG settings menu- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-48

Chapter 6 - Scanning and Display Functions Zooming an image Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-2 Activating Zoom - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-2 Bioeffect - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-2

Split Screen Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-3

Freezing an Image Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-4

Using Cine Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-6 Activating Cine - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-6 Cine controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-6 Cineloop overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-7

Annotating an Image Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-9 Comment retention - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-9 Annotating an image using the library - - - - - - - - - - - - - - - - - - - - - - - - - 6-9 Annotating an image with typed words - - - - - - - - - - - - - - - - - - - - - - - - 6-9 Bodymark - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-10 Arrow Pointers - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-10 Edit while annotating - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-10

Using InSite ExC InSite ExC - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-12 InSite ExC service types - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-12 Initiating a Request for Service (RFS) - - - - - - - - - - - - - - - - - - - - - - - - 6-12 Initiating a Technical or Clinical Support Request- - - - - - - - - - - - - - - - 6-13 InSite ExC definitions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-14 Exiting InSite ExC - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-14

Electronic Documentation Documentation Distribution - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-15 Using online help - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-15 Paper copy- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-15 Available on the Internet - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-16 Electronic media - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-16

Chapter 7 - General Measurements and Calculations Introduction General Instructions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-2

Generic Distance measurements Editing a distance measurement - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-7 Assigning a measurement - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-8 Pre-assigned distance measurements - - - - - - - - - - - - - - - - - - - - - - - - 7-8 Using categories- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-9

B-Mode Measurements Depth Measurement - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-10

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Table of Contents Distance measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-10

Doppler Mode Measurements Velocity - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-15 TAMAX and TAMEAN - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-16 Doppler Auto Calcs control enhancements - - - - - - - - - - - - - - - - - - - - 7-18

M-Mode Measurements Tissue depth - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-20 Distance Measurement on M-Mode - - - - - - - - - - - - - - - - - - - - - - - - - 7-20 Time interval on M-Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-21 Slope (Time interval and Velocity) on M-Mode- - - - - - - - - - - - - - - - - - 7-21 A/B Ratio (diameter, time, or velocity) on M-Mode - - - - - - - - - - - - - - - 7-22

Assessment of Patients in Shock Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-23 Quality indicators - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-23 Auto IVC Tool- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-24 Auto Velocity-Time Integral Tool- - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-29 Auto B-Lines Tool - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-36

Lung Diagram Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-41 Scanning with the Lung diagram - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-41 Lung Review - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-43 Selecting a different Lung diagram - - - - - - - - - - - - - - - - - - - - - - - - - - 7-45 Lung scoring - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-45 Lung Consolidation assessment- - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-47

eFAST navigation tool Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-48 Scanning with the eFAST diagram - - - - - - - - - - - - - - - - - - - - - - - - - - 7-48 eFAST Review - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-51 Selecting a different body diagram - - - - - - - - - - - - - - - - - - - - - - - - - - 7-52

Worksheet To view a worksheet - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-53 To edit a worksheet- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-55 To delete all Worksheet values - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-55 Using the Worksheet- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-56 To delete measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-56 To change a measurement value - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-57

Obstetrics Measurements Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-58 Gestational Sac (GS) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-59 Crown Rump Length (CRL) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-60 Biparietal Diameter (BPD) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-60 Abdominal Circumference (AC) - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-60 Femur Length (FL) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-61 Antero-Postero Trunk Diameter by Transverse Trunk Diameter (AxT) - 7-61 Spine length (SL) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-61 Cardio-Thoracic Area Ratio (CTAR) - - - - - - - - - - - - - - - - - - - - - - - - - 7-61 Amniotic Fluid Index (AFI) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-61 Cervical Length (CL) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-62

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Table of Contents Humerus Length (HL) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-62 Head Circumference (HC) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-62 Fetal Trunk Cross-Sectional Area (FTA) - - - - - - - - - - - - - - - - - - - - - - 7-63 Estimated Fetal Weight (EFW) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-63

OB Worksheet Patient information - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-64 Measurement informations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-65 Calculation information - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-65 OB Worksheet controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-66 OB Worksheet information- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-66

Image Management Searching for an existing patient - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-69 Reviewing previous exams of an existing patient - - - - - - - - - - - - - - - - 7-69 Beginning a new exam for an existing patient - - - - - - - - - - - - - - - - - - 7-69 Editing patient information - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-70 Deleting existing patient/image- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-70 Image storage - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-70

Connectivity Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-73 DICOM Worklist - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-73 Storing images and cineloops - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-75 Review stored images - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-77 Q-View – communication with Q-Path Reporting server - - - - - - - - - - - 7-82 USB media encryption- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-84 DICOM TLS Support - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-84

Chapter 8 - Customizing Your System Preset list Selecting probes and presets- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-2 Generating a new user preset - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-2 Configuring a preset list- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-3 Deleting an application preset - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-5 Generating a new user preset - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-6 Updating a user preset - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-6 To arrange the application presets list- - - - - - - - - - - - - - - - - - - - - - - - - 8-6 Configuration - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-7

Imaging Global Imaging settings - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-9 Probe L4-12t-RS buttons - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-13 Measurement menu - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-14 Advanced- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-22 OB Tables - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-24

Connectivity Dataflow - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-31 Tools - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-37 Patient management presets - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-39 DICOM Images- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-40 Configuration of Connectivity and TCP/IP - - - - - - - - - - - - - - - - - - - - - 8-40 TCP/IP- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-41

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Table of Contents Disk management configuration - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-42 Database maintenance configuration - - - - - - - - - - - - - - - - - - - - - - - - 8-43 Barcode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-43

System Settings - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-45

Admin General - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-48 Backup - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-48 Restore - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-48 System admin - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-49 User policies - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-50 LDAP- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-51 System password - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-52 Disk encryption- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-53 Users- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-54 Adding operator’s initials to the title bar- - - - - - - - - - - - - - - - - - - - - - - 8-57

Chapter 9 - Probes Probe Overview Ergonomics - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-2 Cable handling - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-2 Supported probes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-2 Probe orientation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-4 Labeling- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-4 Probe Usage - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-5 Special handling instructions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-6 Probe handling and infection control - - - - - - - - - - - - - - - - - - - - - - - - - - 9-7

Probe Care and Maintenance Planned maintenance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-8 Inspecting the probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-8 Cleaning and disinfecting probes - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-9 Probe pre-cleaning instructions (Required for all probes) - - - - - - - - - - 9-11 Probe Manual Cleaning Instructions (Required for all probes) - - - - - - - 9-13 Cable and Connector Manual Cleaning- - - - - - - - - - - - - - - - - - - - - - - 9-17 Probe Intermediate-Level Disinfection - Spray - - - - - - - - - - - - - - - - - - 9-18 Probe Intermediate-Level Disinfection - Wipe - - - - - - - - - - - - - - - - - - 9-19 Probe High Level Disinfection – Soak - - - - - - - - - - - - - - - - - - - - - - - - 9-21 Probe High-Level Disinfection - trophon® EPR - - - - - - - - - - - - - - - - - 9-24 Chemicals Used for Efficacy Validation - - - - - - - - - - - - - - - - - - - - - - - 9-25 Covering the Transducer using a Sterile, Protective Sheath - - - - - - - - 9-34 Coupling gels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-35 Planned Maintenance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-36

Probe Safety Handling precautions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-37 Electrical shock hazard - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-38 Mechanical hazards - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-38 6Tc-RS Probe Thermal Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-39 Biological hazards- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-40 Endocavitary Probe Handling Precautions- - - - - - - - - - - - - - - - - - - - - 9-41

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Table of Contents Probe Discussion Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-42 Application list configuration- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-48

Biopsy Discussion “Infinity PlusTM” type Biopsy bracket - - - - - - - - - - - - - - - - - - - - - - - - - 9-49 Biopsy Special Concerns- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-50

Preparing for a Biopsy Preparing “Infinity PlusTM” or “AccuSITETM” type Needle Guide Attachment- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-51

Surgery/Intra-operative Use

Chapter 10 - User Maintenance Clinical Measurement Accuracy Basic Measurements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-2

Anti-Virus Software Note Venue Go Security - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-4

System Care and Maintenance Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-6 Inspecting the System - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-7 Weekly Maintenance- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-7 Cleaning the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-8 Other Maintenance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-11

Index

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Chapter 1 Introduction

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

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Introduction

System Overview

This manual contains necessary and sufficient information to operate the system safely. Read and understand all instructions in this manual before attempting to use the Venue Go system. Keep this manual with the equipment at all times. Periodically review the procedures for operation and safety precautions. Disregarding information on safety is considered abnormal use. Not all features, products, probes, or peripherals described in this document may be available or cleared for sale in all markets. Please contact your local GE Ultrasound representative to get the latest information.

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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.

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System Overview Documentation CAUTION

Safety instructions must be reviewed before operating the unit.

Venue Go documentation consists of various manuals:

NOTE:

•

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 Release Notes (TRANSLATED) provide precautions and instructions that supplement the Basic User Manual.

•

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

•

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.

The eDocumentation kit provides instructions on how to read the user documentation via electronic media. All user manuals are provided in electronic format. The eDocumenation media includes English and all other translations. The Venue Go 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 Basic User Manual is provided only in electronic format. The electronic documentation disk-on-key includes English and all translations.

NOTE:

The Advanced Reference Manual and Basic Service Manual are provided only in electronic format on the disk-on-key.

NOTE:

The screen graphics in this manual are only for illustrational purposes. Actual screen output may differ.

NOTE:

Probe information displayed on screen examples does not necessarily reflect the probes available on your ultrasound system. Please refer to the Probes chapter for a listing of available probes and features.

NOTE:

Dates on screenshots are represented in DD/MM/YYYY format throughout the manual. Information on how to change the system's date can be found in Customizing Your System.

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Introduction Principles of Operation Medical ultrasound images are created by computer and digital memory from the transmission and reception of mechanical high-frequency waves applied through a transducer. The mechanical ultrasound waves spread through the body, producing an echo where density changes occur. For example, in the case of human tissue, an echo is created where a signal passes from an adipose tissue (fat) region to a muscular tissue region. The echoes return to the transducer where they are converted back into electrical signals. These echo signals are highly amplified and processed by several analog and digital circuits having filters with many frequency and time response options, transforming the high-frequency electrical signals into a series of digital image signals which are stored in memory. Once in memory, the image can be displayed in real-time on the image monitor. All signal transmission, reception and processing characteristics are controlled by the main computer. By selection from the system control panel, the user can alter the characteristics and features of the system, allowing a wide range of uses, from obstetrics to peripheral vascular examinations. Transducers are accurate, solid-state devices, providing multiple image formats. The digital design and use of solid-state components provide highly stable and consistent imaging performance with minimal required maintenance. Sophisticated design with computer control offers a system with extensive features and functions which is user-friendly and easy to use.

Indications for Use Venue Go is a general-purpose diagnostic ultrasound system intended for use by qualified healthcare professionals for ultrasound imaging, measurement and analysis of the human body and fluid. Venue Go clinical applications include the following: Abdominal (including Gynecology and Urology), Thoracic/Pleural, Ophthalmic, Fetal/Obstetrics, Small Organ (including breast, testes, thyroid), Peripheral vascular, Adult and neonatal cephalic, Pediatric, Musculoskeletal (Conventional and Superficial), Cardiac (Adults and Pediatric), Transesophageal, Transrectal, Transvaginal, Intraoperative and Imaging guidance for interventional procedures (e.g. Nerve block, biopsy, vascular access). A list of presets per probe is provided in ‘Probe Discussion’ on page 9-42.

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