Venue Fit Basic User Manual Rev 3.0

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

First CE mark in 2020 This manual is a reference for the Venue Fit. It applies to software version 303.45.0.345 or higher software for the Venue Fit 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

2020/08/30

Initial release (DOC2434500)

Rev. 2

2020/11/25

Updated: graphics, chapter 9, various small changes and corrections.

Rev. 3

2021/03/02

Addition of Wuxi manufacturing site.

List of Effective Pages PAGE NUMBER

REVISION NUMBER

All pages

Rev. 1

All pages

Rev. 2

All pages

Rev. 3

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.

Venue Fit – Basic User Manual Direction 5857649-100 Rev. 3

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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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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

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Venue Fit – Basic User Manual Direction 5857649-100 Rev. 3

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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)

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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). •

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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 GE Medical Systems (China) Co., Ltd. is ISO 13485 certified.

Original Documentation •

The original document was written in English.

Country Specific Approval •

JAPAN MHLW Certified Number:

Venue Fit – Basic User Manual Direction 5857649-100 Rev. 3

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Importer information

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Venue Fit – Basic User Manual Direction 5857649-100 Rev. 3

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 Intended Use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-4 Indications for Use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-4 Clinical benefit - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-5 Frequency of Use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-5 Patient population - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-6 Operator Profile - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-6 Prescription Device - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-6

Contact Information Contacting GE Ultrasound - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-7 Manufacturer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-11 Factory sites- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-11

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

Bioeffect Disclosure Bioeffect disclosure- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-3

Safety Precautions Precaution Levels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-4 Hazard Symbols - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-5 Patient Safety- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-6 Equipment and Personnel Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-10 General Caution - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-15 EMC (Electromagnetic Compatibility) - - - - - - - - - - - - - - - - - - - - - - - - 2-16 Patient Environmental Devices- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-27 Acoustic Output - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-28 Federal Communications Commission (FCC) Statement - - - - - - - - - - 2-32 RoHS Venue Fit Hazardous Substances- - - - - - - - - - - - - - - - - - - - - - 2-33 Environmental protection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-35

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Table of Contents Device Labels Label Locations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-37 Warning Label Locations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-39 Probe Label Explanation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-42 Battery Label Explanation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-43 Icon description - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-44

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 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-9 Battery- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-10 Peripheral/Accessory Connection- - - - - - - - - - - - - - - - - - - - - - - - - - - 3-16 Peripherals Connection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-19

System Positioning/Transporting Using the cart - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-29 Moving the System with the cart- - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-31 Before moving the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-32 When moving the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-32 Transporting the System - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-33 Reinstalling at a new location- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-34

Powering the System Battery Status Indicator - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-36 Connecting the System to AC power - - - - - - - - - - - - - - - - - - - - - - - - 3-36

Adjusting the system’s position on the cart Tilt, raise, and lower Venue Fit on a cart - - - - - - - - - - - - - - - - - - - - - - 3-42 Adjusting the monitor's Brightness - - - - - - - - - - - - - - - - - - - - - - - - - - 3-42

Probes Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-45 Connecting the Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-45 Cable Handling - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-46 Selecting probes- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-47 Activating the Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-47 Disconnecting the Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-47 Transporting Probes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-48 Storing the Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-48

Operator Controls Touch display - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-49

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Table of Contents Chapter 4 - Performing an Exam Overview Begin a new exam Beginning a new patient - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-3 Ending the previous exam - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-4 Turning On a system containing a non-empty exam - - - - - - - - - - - - - - - 4-5 Entering patient’s details - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-6 Scanning without entering any patient data - - - - - - - - - - - - - - - - - - - - - 4-7 Beginning a New Exam for a patient appearing in Archive - - - - - - - - - - 4-8 Selecting a patient from the Patient list to perform a new exam - - - - - - - 4-8 Navigating the patient list- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-8 Reviewing patient exams- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-9 Worklist - Search and retrieve the Patient/Exam information - - - - - - - - 4-14 Selecting the probe and preset- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-15 Selecting probe and preset via main screen shortcuts - - - - - - - - - - - - 4-17 Scanning - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-17 Storing loops or images- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-17 Making measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-18 Adding findings- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-18 Adding annotations to an image - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-19 Review exam’s stored images - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-19 Review all measurements taken during an exam - - - - - - - - - - - - - - - - 4-19

Follow-up tool Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-20 The Follow-up exam - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-20

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 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-21 Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-21 Optimizing Color Flow - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-22

M-Mode Intended Use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-30 Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-30 Typical exam protocol - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-30 M-Mode Display & Controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-31

M Color Flow Mode Description- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-34 Activating - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-34

Spectral Doppler Intended Use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-35 Spectral Doppler Display - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-35 Typical exam protocol - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-36 PW Doppler Mode Display- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-37

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Table of Contents Activating Triplex Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-38 CW Doppler - Steerable Continuous Wave Doppler (CW)- - - - - - - - - - 5-38 Activating CW Doppler - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-38 TDI mode- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-46

ECG (option) Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-48 Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-48 ECG electrodes for Pediatrics - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-50 ECG cable - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-51 ECG settings menu- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-52

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 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-7 Cineloop overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-7

Annotating an Image Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-10 Comment retention - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-10 Annotating an image using the library - - - - - - - - - - - - - - - - - - - - - - - - 6-10 Annotating an image with typed words - - - - - - - - - - - - - - - - - - - - - - - 6-10 Edit while annotating - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-11 Bodymark - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-12 Arrow Pointers - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-12

Using InSite RSVP InSite RSVP - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-13 Types of InSite RSVP service - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-13 Initiating a Request for Service (RFS) - - - - - - - - - - - - - - - - - - - - - - - - 6-13 Initiating a Technical or Clinical Support Request- - - - - - - - - - - - - - - - 6-15 InSite RSVP definitions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-16 Exiting InSite RSVP - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-17

Electronic Documentation Documentation Distribution - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-18 Using online help - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-18 Paper copy- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-18 Available on the Internet - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-19 Electronic media - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-19

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Table of Contents Chapter 7 - General Measurements and Calculations Introduction General Instructions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-2

Generic Distance measurements Moving or minimizing the result window - - - - - - - - - - - - - - - - - - - - - - - 7-7 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 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-11 Distance measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-11

Doppler Mode Measurements Velocity - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-16 TAMAX and TAMEAN - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-17 Doppler Auto Calcs control enhancements - - - - - - - - - - - - - - - - - - - - 7-19

M-Mode Measurements Tissue depth - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-21 Distance Measurement on M-Mode - - - - - - - - - - - - - - - - - - - - - - - - - 7-21 Time interval on M-Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-22 Slope (Time interval and Velocity) on M-Mode- - - - - - - - - - - - - - - - - - 7-22 A/B Ratio (diameter, time, or velocity) on M-Mode - - - - - - - - - - - - - - - 7-23

Assessment of Patients in Shock Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-24 Quality indicators - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-24 Auto IVC Tool- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-25 Auto Velocity-Time Integral Tool- - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-30 Auto B-Lines Tool - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-38

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

Lung Sweep Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-50

eFAST navigation tool Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-59 Scanning with the eFAST diagram - - - - - - - - - - - - - - - - - - - - - - - - - - 7-59 eFAST Review - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-62 Selecting a different body diagram - - - - - - - - - - - - - - - - - - - - - - - - - - 7-63

Renal Diagram Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-64 Scanning with the Renal Diagram- - - - - - - - - - - - - - - - - - - - - - - - - - - 7-64 Renal Review - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-66

Real-time EF Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-67

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Table of Contents Accuracy - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-68 Acquisition - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-69 Freezing - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-70 Performing Real-Time EF on a stored loop - - - - - - - - - - - - - - - - - - - - 7-72 Selecting a different heart-cycle - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-72 Using the ECG signal - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-72 To exit Real-Time EF - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-73

Worksheet To view a worksheet - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-74 To edit a worksheet- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-76 To delete all Worksheet values - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-76 Using the Worksheet- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-77 To delete measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-77 To change a measurement value - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-78

Obstetrics Measurements Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-79 Gestational Sac (GS) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-80 Crown Rump Length (CRL) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-81 Biparietal Diameter (BPD) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-81 Abdominal Circumference (AC) - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-81 Femur Length (FL) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-82 Antero-Postero Trunk Diameter by Transverse Trunk Diameter (AxT) - 7-82 Spine length (SL) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-82 Cardio-Thoracic Area Ratio (CTAR) - - - - - - - - - - - - - - - - - - - - - - - - - 7-82 Amniotic Fluid Index (AFI) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-82 Cervical Length (CL) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-83 Humerus Length (HL) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-83 Head Circumference (HC) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-83 Fetal Trunk Cross-Sectional Area (FTA) - - - - - - - - - - - - - - - - - - - - - - 7-84 Estimated Fetal Weight (EFW) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-84

OB Worksheet Patient information - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-85 Measurement informations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-86 Calculation information - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-86 OB Worksheet controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-87 OB Worksheet information- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-87

Image Management Searching for an existing patient - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-90 Reviewing previous exams of an existing patient - - - - - - - - - - - - - - - - 7-90 Beginning a new exam for an existing patient - - - - - - - - - - - - - - - - - - 7-90 Editing patient information - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-91 Deleting existing patient/image- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-91 Image storage - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-91

Connectivity Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-94 DICOM Worklist - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-94 Storing images and cineloops - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-96 Review stored images - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-98

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Table of Contents Q-View – communication with Q-Path Reporting server - - - - - - - - - - 7-103 USB media encryption- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-105 DICOM TLS Support - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-105

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 settings - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-9 Application presets - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-11 Advanced tools- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-13 Button Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-13 Simple screen - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-14 Needle- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-15

Measurement menu Display of the Measurement categories - - - - - - - - - - - - - - - - - - - - - - 8-17 Moving an item in the Measurement menu - - - - - - - - - - - - - - - - - - - - 8-18 Deleting an item in the Measurement menu- - - - - - - - - - - - - - - - - - - - 8-18 Display/hide a folder or a measurement in the Measurement menu - - - 8-18 Auto-sequence of measurements within a folder - - - - - - - - - - - - - - - - 8-18 Creating a user-defined folder - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-18 Changing or adding measurement paramenters - - - - - - - - - - - - - - - - 8-19 Advanced- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-25 Modify Calcs - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-26 OB Tables - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-27 Text Annotation and Bodymark confiuration - - - - - - - - - - - - - - - - - - - 8-29 Options - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-31

Connectivity Dataflow - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-33 Additional outputs - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-39 Tools - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-39 QView - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-41 Formats - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-41 TCP/IP Connectivity Configuration - - - - - - - - - - - - - - - - - - - - - - - - - - 8-42 Disk Management- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-44 Database maintenance configuration - - - - - - - - - - - - - - - - - - - - - - - - 8-44 Barcode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-45

System Settings - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-47

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Table of Contents About - System configuration information Admin General - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-50 Backup - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-50 Restore - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-50 Users- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-51 System admin - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-55 User policies - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-55 LDAP- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-56 System password - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-57 Disk encryption- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-58

Chapter 9 - Probes and Biopsy Probe Overview Ergonomics - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-2 Cable handling - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-2 Supported probes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-2 Probe orientation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-4 Labeling- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-5 Probe Usage - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-5 Special handling instructions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-7 Probe handling and infection control - - - - - - - - - - - - - - - - - - - - - - - - - - 9-8

Probe Care and Maintenance Planned maintenance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-9 Inspecting the probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-9 Cleaning and disinfecting probes - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-10 Probe Pre-Treatment at the Point of Use (Required for All Probes) - - - 9-13 Probe Manual Cleaning Instructions - - - - - - - - - - - - - - - - - - - - - - - - - 9-15 Cable and Connector Manual Cleaning- - - - - - - - - - - - - - - - - - - - - - - 9-19 Probe Intermediate-Level Disinfection (ILD) - - - - - - - - - - - - - - - - - - - 9-20 Probe ILD - Disinfectant Wipe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-21 Probe High Level Disinfection (HLD)- - - - - - - - - - - - - - - - - - - - - - - - - 9-23 Compatible Chemicals - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-25 Covering the Transducer using a Sterile, Protective Sheath - - - - - - - - 9-41 Coupling gels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-42 Planned Maintenance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-43

Probe Safety Handling precautions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-44 Electrical shock hazard - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-45 Mechanical hazards - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-45 6Tc-RS Probe Thermal Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-46 Biological hazards- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-47 Endocavitary Probe Handling Precautions- - - - - - - - - - - - - - - - - - - - - 9-48

Probe Discussion Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-49 Application list configuration- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-56

Biopsy Discussion Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-57

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Table of Contents Ultra-Pro IITM In-Plane Ultrasound Needle Guides - Multi-Angle - - - - - 9-58 “Infinity PlusTM” type Biopsy bracket - - - - - - - - - - - - - - - - - - - - - - - - - 9-58 VerzaTM Ultrasound Needle Guidance - multi-angle, in-plane - - - - - - - 9-59

Probe biopsy reprocessing Manual cleaning - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-61 High-level Disinfection- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-62 Autoclave Sterilization - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-62

Preparing for a Biopsy Preparing Infinity PlusTM or AccuSITETM needle guide attachments - - 9-63

Biopsy Special Concerns Precautions Concerning the Use of Biopsy Procedures - - - - - - - - - - - 9-65

Performing a Biopsy Displaying the Guidezone - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-67 Preparing the Biopsy Guide Attachment - - - - - - - - - - - - - - - - - - - - - - 9-68 Multi Angle Biopsy Guide Assembly - - - - - - - - - - - - - - - - - - - - - - - - - 9-69 Removing the biopsy guide - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-73 Releasing the needle - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-74 Biopsy Needle Path Verification - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-74 The Biopsy Procedure- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-75

Surgery/Intra-operative Use

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

Privacy and Security Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-4 Abbreviations and definitions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-5 Privacy & Security Environment - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-7 Privacy & Security Capabilities- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-7 Information Protection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-16 System Protection- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-31 Remote Service - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-34 Personal Information Collected by the Product - - - - - - - - - - - - - - - - 10-35 Potential Hazardous Situations Resulting from IT Network Failures - - 10-38 Conclusion - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-39 Appendix A: MDS2 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-39 Appendix B: Disabled windows services - - - - - - - - - - - - - - - - - - - - - 10-39 Appendix C: Software of Unknown Provenance (SOUP)- - - - - - - - - - 10-46

Anti-Virus Software Note Venue Fit Security - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-50

System Care and Maintenance Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-52 Inspecting the System - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-53 Weekly Maintenance- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-53 Cleaning the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-54 Other Maintenance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-57

Index

Venue Fit – Basic User Manual Direction 5857649-100 Rev. 3

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Table of Contents

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Venue Fit – Basic User Manual Direction 5857649-100 Rev. 3

Chapter 1 Introduction

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

Venue Fit – Basic User Manual Direction 5857649-100 Rev. 3

1-1

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 Fit system. Keep this manual with the equipment at all times. Periodically review the procedures for operation and safety precautions. NOTE:

The Online Help offers a quick way for the user to access the manual. 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.

1-2

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.

Venue Fit – Basic User Manual Direction 5857649-100 Rev. 3

System Overview Documentation CAUTION

Safety instructions must be reviewed before operating the unit.

Venue Fit 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.

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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 Fit 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.

Venue Fit – Basic User Manual Direction 5857649-100 Rev. 3

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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.

Intended Use Venue Fit is a general purpose diagnostic ultrasound system for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Venue Fit is intended to be used in a hospital or medical clinic.

Indications for Use The Venue Fit is a general-purpose diagnostic ultrasound system for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Venue Fit is intended to be used in a hospital or medical clinic. Venue Fit clinical applications include: abdominal (GYN and Urology), thoracic/pleural, ophthalmic, Fetal/OB, Small Organ (including breast, testes, thyroid),

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Venue Fit – Basic User Manual Direction 5857649-100 Rev. 3