Venue 50 Basic User Manual Rev 15 Jan 2021

Regulatory Requirement Venue 50 complies with regulatory requirements of the following European Directive 93/42/EEC concerning medical devices.

This manual is a reference for the Venue 50. It applies to all versions of the R4.x.x and R5.x.x software for the Venue 50 ultrasound system. The PinpointTM GT Needle Guidance Technology is used under license from C. R. Bard, Inc. Bard, Pinpoint, and Pinpoint GT are trademarks and/or registered trademarks of C. R. Bard, Inc.

GE P.O. Box 414, Milwaukee, Wisconsin 53201 U.S.A. (Asia, Pacific, Latin America, North America) GE Ultraschall Deutschland GmbH & Co. KG Beethovenstrasse 239 Postfach 11 05 60 D-42655 Solingen GERMANY TEL: 49 212.28.02.208; FAX: 49 212.28.02.431

Revision History Reason for Change

REV

DATE (YYYY/MM/DD)

REASON FOR CHANGE

Rev.1

2015/04/08

Initial Release

Rev.2

2016/01/05

Update software features and rating plate

Rev.3

2016/05/27

Remove needle size information

Rev.4

2016/06/29

Update probe application information

Rev.5

2016/08/23

Add probe UDI label

Rev.6

2016/12/08

Update software features and device label

Rev.7

2017/03/20

Update rating plate

Rev.8

2017/05/05

Update rating plate

Rev.9

2018/09/18

Update Korea address

Rev.10

2018/11/29

1. Update EMC Content 2. Update EU Representative Information

Rev.11

2019/05/29

Update Brazil contact address

Rev.12

2020/01/08

1. Update Brazil contact address 2. Update Brazil label Information

Rev.13

2020/02/11

Remove Authorized Representative in Ukraine

Rev.14

2020/04/13

Add authorized representative in Kazakhstan

Rev.15

2021/01/20

1. Add Brazil Importer information 2. Update Brazil telephone number

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List of Effective Pages

CHAPTER NUMBER

REVISION NUMBER

CHAPTER NUMBER

REVISION NUMBER

Title Page

Rev. 15

Chapter 3

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Revision History

Rev. 15

Chapter 4

Rev. 15

Regulatory Requirements

Rev. 15

Chapter 5

Rev. 15

Table of Contents

Rev. 15

Chapter 6

Rev. 15

Chapter 1

Rev. 15

Index

Rev. 15

Chapter 2

Rev. 15

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

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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. According to IEC/EN 60601-1, •

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

•

Docking Station/Cart is Class 1.

•

Continuous Operation.

According to CISPR 11, •

Equipment is Group 1, Class A ISM Equipment.

•

Docking Station/Cart is Group 1, Class A ISM Equipment.

According to IEC 60529, •

The footswitch rate is IP X8 (MKF 2 1S/1S-MED HID GP 26).

•

Probe head (immersible portion) and cable are IPX7. Probe connector is not waterproof.

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 Minière 78530 BUC, France

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Venue 50 – Basic User Manual Direction 5589758-100 English Rev. 15

Conformance Standards (continued) •

•

International Electrotechnical Commission (IEC): •

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

•

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

•

IEC/EN 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): •

•

ISO 10993-1 Biological evaluation of medical devices.

Canadian Standards Association (CSA): •

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).

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Certifications •

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

•

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC. is ISO 9001 and ISO 13485 certified.

Original Documentation •

The original document was written in English.

Country Specific Approval •

JAPAN MHLW Certified Number:221ABBZX00092000

•

BRAZIL Registro ANVISA N°:80071260335

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Importer Information Table i-1:

Importer

Turkey

Brazil

Authorized Representative in Kazakhstan

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Table of Contents

Conformance Standards - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-4 Certifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-6 Original Documentation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-6 Country Specific Approval - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-6 Importer Information - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-7 Authorized Representative in Kazakhstan - - - - - - - - - - - - - - - - - - - - - - - i-7

Table of Contents Chapter 1 - Introduction/Safety System Overview Attention - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-2 Documentation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3 Principles of Operation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-4 Indications for Use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-5 Frequency of Use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-5 Operator Profile - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-5 Prescription Device - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-5

Owner Responsibility Owner requirements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-6 Notice against user modification- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-7

Safety Precautions Precaution Levels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-8 Hazard Symbols - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-9 Patient Safety- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-11 Equipment and Personnel Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-15 General Caution - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-20 EMC (Electromagnetic Compatibility) - - - - - - - - - - - - - - - - - - - - - - - - 1-21 Minimum distances - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-32 Wireless Adapter Specification- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-33 Basic Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-34 Essential performance- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-34 Patient Environmental Devices- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-35 Acoustic Output - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-37 RoHS Venue 50 Hazardous Substances- - - - - - - - - - - - - - - - - - - - - - 1-40

Device Labels Icon Description - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-42 Warning label locations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-48 Probe Label Explanation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-54 Probe Box Label - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-55

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UDI Global Trade Item Number (GTIN) Label and Probe Box Barcode Locations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-55

Chapter 2 - Preparing the System for Use Site Requirements Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-2 Before the system arrives - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-3 Environmental Requirements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-4 Acclimation Time - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-4

Console Overview Console graphics - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-5 Peripheral/Accessory Connection- - - - - - - - - - - - - - - - - - - - - - - - - - - 2-13

System Positioning/Transporting Moving the System - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-23 When moving the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-24 Transporting the System - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-26 Attaching the Security Cable - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-27

Powering the System Connecting and Using the System - - - - - - - - - - - - - - - - - - - - - - - - - - 2-29

Adjusting the Display Monitor Tilt LCD monitor - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-34 Adjusting the Docking Cart - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-35 Brightness - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-37

Probes Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-39 Selecting probes- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-39 Connecting the Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-40 Cable Handling - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-41 Deactivating the Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-41 Disconnecting the Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-42 Transporting Probes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-43 Storing the Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-43

Touch Panel Exam Function Controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-44

Monitor Display Monitor Display- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-46

Chapter 3 - Performing an Exam Performing an Exam Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-2

Begin a new exam Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-3

Image Scanning B Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-8 Color Flow Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-13 Power Doppler Imaging (PDI) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-15 M Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-17

Measurements Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-19

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B Mode Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-20 M Mode Measurements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-29 Obstetrics Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-33 Gestational Sac (GS) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-34 Crown Rump Length (CRL) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-35 Biparietal Diameter (BPD) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-35 Abdominal Circumference (AC) - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-36 Femur Length (FL) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-37 Antero-Postero Trunk Diameter by Transverse Trunk Diameter (AxT) - 3-37 Spine Length (SL)- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-38 Cardio-Thoracic Area Ratio (CTAR) - - - - - - - - - - - - - - - - - - - - - - - - - 3-38 Amniotic Fluid Index (AFI) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-39 Cervical Length (CL) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-40 Humerus Length (HL) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-40 Head Circumference (HC) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-41 Fetal Trunk Cross-Sectional Area (FTA) - - - - - - - - - - - - - - - - - - - - - - 3-42 Estimated Fetal Weight (EFW) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-42

Annotations Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-43 Comment Retention - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-43 Annotating an image using the library - - - - - - - - - - - - - - - - - - - - - - - 3-44 Annotating an image with typed words - - - - - - - - - - - - - - - - - - - - - - - 3-48 Bodymark - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-49 Arrow Pointers - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-50 Edit while annotating - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-51 Annotation Controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-51

OB Worksheet Activating the Worksheet - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-53 OB Worksheet Controls- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-54 OB Worksheet information- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-55 Editing OB Worksheet - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-63 OB Report - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-64 Multi gestational - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-66 Storing an OB Report - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-67

Image Management Zooming an Image - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-68 Split Screen - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-69 Using Cine - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-70 Review Archived Information - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-73 Image Storage - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-81 Smart Trainer (Option) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-94

Chapter 4 - Customizing Your System Utility Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-2 General - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-3 Settings - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-11 GT Configuration (for R5.x.x) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-24 Image - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-27

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Measure - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-35 System - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-38 Connectivity - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-40 About- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-50

Chapter 5 - Probes and Biopsy Probe Overview Ergonomics - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-2 Cable handling - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-2 Probe orientation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-3 Labeling- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-4 Probe Naming Conventions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-4 Probe Usage - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-5 Care and Maintenance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-5 Probe Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-6 Special handling instructions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-8 Probe handling and infection control - - - - - - - - - - - - - - - - - - - - - - - - - 5-10 Probe Cleaning Process - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-11

Probe Discussion Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-19 Probe Applications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-20 Probe Specifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-21 Probe Slice Thickness Specifications - - - - - - - - - - - - - - - - - - - - - - - - 5-21 Probe Illustration- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-22

Guidance Technology Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-23 Prepare for needle tracking - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-24 Applying needle tracking - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-25

Biopsy Special Concerns Precautions Concerning the Use of Biopsy Procedures - - - - - - - - - - - 5-39

Preparing for a Biopsy Displaying the Guidezone - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-41 Preparing the Biopsy Guide Attachment - - - - - - - - - - - - - - - - - - - - - - 5-44 Biopsy Needle Path Verification - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-54 The Biopsy Procedure- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-55 Post Biopsy - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-57

Surgery/Intra-operative Use Preparing for Surgery/Intra-operative Procedures - - - - - - - - - - - - - - - 5-58

Chapter 6 - User Maintenance System Data Features/Specifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-2 Clinical Measurement Accuracy - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-9

Anti-Virus Software Note Venue 50 Security - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-12

System Care and Maintenance Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-14 Inspecting the System - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-15 Weekly Maintenance- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-16

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Cleaning the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-17 Other Maintenance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-20

Quality Assurance Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-21 Typical Tests to Perform - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-22 Baselines - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-24 Periodic Checks - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-24 Results - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-25 System Setup- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-26 Test Procedures - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-26 Setting up a Record Keeping System - - - - - - - - - - - - - - - - - - - - - - - - 6-35 Ultrasound Quality Assurance Checklist - - - - - - - - - - - - - - - - - - - - - - 6-36

Supplies/Accessories Peripherals- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-37 Console - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-38 Probes- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-38 Gel - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-38

Contact Information Contacting GE Ultrasound - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-39 Manufacturer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-45 Factory Sites - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-46

Index

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Chapter 1 Introduction/Safety This chapter consists of information concerning indications for use, how documents are organized (?), and the safety and regulatory information pertinent for operating this ultrasound system.

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Introduction/Safety

System Overview

Attention 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 50 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. When there are difference between Online Help and Basic User Manual/User Guide, please refer to Basic User Manual/User Guide for the only right version. 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 50 documentation consists of various manuals: •

The Basic User Manual (TRANSLATED) and User Guide (ENGLISH ONLY) provide information needed by the operator to operate the system safely. They describe the basic functions of the system, safety features, operating modes, measurements/calculations, probes, user care and maintenance.

•

The Quick Card (TRANSLATED) provides descriptions of basic system features and operation. It is intended to be used in conjunction with the Basic User Manual in order to provide the information necessary to operate the system safely.

•

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.

•

AIUM Booklet (USA only)

The Venue 50 manuals are written for operators 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.

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.

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Introduction/Safety 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 operator 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 provides 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.

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