Venue 50 Basic User Manual sw ver R4.XX Rev 7

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 software for the Venue 50 ultrasound system.

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 DATE (YYYY/MM/DD)

REV

REASON FOR CHANGE

Rev.1

2013/01/04

Initial Release

Rev.2

2013/05/21

Update UI and software functions

Rev.3

2013/09/17

Update UI and software functions

Rev.4

2013/12/12

Update UI and software functions

Rev.5

2014/01/13

Update UI

Rev.6

2014/03/13

Remove “NOTE: 10C-SC is not available in U.S.”

Rev.7

2014/09/05

Software updated

List of Effective Pages

SECTION NUMBER

REVISION NUMBER

SECTION NUMBER

REVISION NUMBER

Title Page

Rev. 7

Chapter 3

Rev. 7

Revision History

Rev. 7

Chapter 4

Rev. 7

Regulatory Requirements

Rev. 7

Chapter 5

Rev. 7

Table of Contents

Rev. 7

Chapter 6

Rev. 7

Chapter 1

Rev. 7

Index

Rev. 7

Chapter 2

Rev. 7

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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Venue 50 – Basic User Manual Direction 5446729-100 English Rev. 7

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 European registered place of business: GE Medical Systems Information Technologies GmbH (GEMS IT GmbH) Munzinger Strasse 5, D-79111 Freiburg, GERMANY Tel: +49 761 45 43 -0; Fax: +49 761 45 43 -233

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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 compatibility 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): •

•

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.

•

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).

Venue 50 – Basic User Manual Direction 5446729-100 English Rev. 7

Certifications •

General Electric Medical Systems is ISO 9001 and ISO 13485 certified.

Original Documentation •

The original document was written in English.

Country Specific Approval •

JAPAN MHLW Certified Number: 221ABBZX00092000

Importer Information •

Turkey

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Table of Contents

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

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 Patient Environmental Devices- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-28 Acoustic Output - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-30

Device Labels Icon Description - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-33 Warning label locations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-37

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

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System Positioning/Transporting Moving the System - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-21 When moving the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-22 Transporting the System - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-24 Attaching the Security Cable - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-25

Powering the System Connecting and Using the System - - - - - - - - - - - - - - - - - - - - - - - - - - 2-27

Adjusting the Display Monitor Tilt LCD monitor - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-32 Adjusting the Docking Cart - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-33 Brightness - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-35

Probes Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-36 Selecting probes- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-36 Connecting the Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-37 Cable Handling - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-38 Deactivating the Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-38 Disconnecting the Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-39 Transporting Probes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-40 Storing the Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-40

Touch Panel Exam Function Controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-41

Monitor Display Monitor Display- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-42

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 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-11 Power Doppler Imaging (PDI) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-14 M Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-16

Measurements Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-18 B Mode Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-19 M Mode Measurements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-27 Obstetrics Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-31 Gestational Sac (GS) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-32 Crown Rump Length (CRL) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-34 Biparietal Diameter (BPD) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-35 Abdominal Circumference (AC) - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-36 Femur Length (FL) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-38 Antero-Postero Trunk Diameter by Transverse Trunk Diameter (AxT) - 3-39 Spine Length (SL)- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-40 Cardio-Thoracic Area Ratio (CTAR) - - - - - - - - - - - - - - - - - - - - - - - - - 3-41

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Amniotic Fluid Index (AFI) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-42 Cervical Length (CL) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-44 Humerus Length (HL) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-45 Head Circumference (HC) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-46 Fetal Trunk Cross-Sectional Area (FTA) - - - - - - - - - - - - - - - - - - - - - - 3-48 Estimated Fetal Weight (EFW) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-49

Annotations Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-50 Comment Retention - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-50 Annotating an image using the library - - - - - - - - - - - - - - - - - - - - - - - 3-51 Annotating an image with typed words - - - - - - - - - - - - - - - - - - - - - - - 3-55 Bodymark - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-56 Arrow Pointers - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-57 Edit while annotating - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-58 Annotation Controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-58

OB Worksheet Activating the Worksheet - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-60 OB Worksheet Controls- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-61 OB Worksheet information- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-62 Editing OB Worksheet - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-70 OB Report - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-71 Multi gestational - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-73 Storing an OB Report - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-74

Image Management Zooming an Image - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-75 Split Screen - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-76 Using Cine - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-77 Review Archived Information - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-80 Image Storage - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-88 eSmart Trainer (Option)- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-101

Chapter 4 - Customizing Your System Utility Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-2 General - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-3 Settings - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-5 Image - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-13 Measure - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-19 System - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-22 Connectivity - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-24 About- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-33

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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

Biopsy Special Concerns Precautions Concerning the Use of Biopsy Procedures - - - - - - - - - - - 5-23

Preparing for a Biopsy Displaying the Guidezone - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-25 Preparing the Biopsy Guide Attachment - - - - - - - - - - - - - - - - - - - - - - 5-28 Biopsy Needle Path Verification - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-38 The Biopsy Procedure- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-39 Post Biopsy - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-41

Surgery/Intra-operative Use Preparing for Surgery/Intra-operative Procedures - - - - - - - - - - - - - - - 5-42

Chapter 6 - User Maintenance System Data Features/Specifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-2 Clinical Measurement Accuracy - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-8

Anti-Virus Software Note Venue 50 Security - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-11

System Care and Maintenance Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-13 Inspecting the System - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-14 Weekly Maintenance- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-15 Cleaning the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-16 Other Maintenance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-19

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Quality Assurance Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-20 Typical Tests to Perform - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-21 Baselines - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-23 Periodic Checks - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-23 Results - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-24 System Setup- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-25 Test Procedures - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-25 Setting up a Record Keeping System - - - - - - - - - - - - - - - - - - - - - - - - 6-34 Ultrasound Quality Assurance Checklist - - - - - - - - - - - - - - - - - - - - - - 6-35

Supplies/Accessories Peripherals- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-36 Console - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-37 Probes- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-37 Gel - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-37

Contact Information Contacting GE Ultrasound - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-38 Manufacturer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-44

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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1-1

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. Disregarding information on safety is considered abnormal use. Not all features or products described in this document may be available or cleared for sale in all markets. Please contact your local GE 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.

Venue 50 – Basic User Manual Direction 5446729-100 English Rev. 7

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.

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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.

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

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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.

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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.

Venue 50 – Basic User Manual Direction 5446729-100 English Rev. 7

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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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Venue 50 – Basic User Manual Direction 5446729-100 English Rev. 7

System Overview Indications for Use The Venue 50 is intended for use by a qualified physician or sonographer for ultrasound evaluation. The Venue 50 is intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications including: Ophthalmic; Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Musculoskeletal Conventional & Superficial; Transvaginal; Intraoperative (abdominal, thoracic and peripheral); Thoracic/Pleural for motion and fluid detection and imaging guidance of interventional procedures (Tissue Biopsy/ Fluid Drainage, Vascular Access, Nonvascular). NOTE:

WARNING

Ophthalmic and Orbits are not available for Japan. To avoid injury to the patient, select the Ophthalmic or Orbits preset when performing an eye exam. The system will not exceed the lower acoustic energy limits for ophthalmic use only if the Ophthalmic or Orbits preset is selected. Be sure to use the appropriate probes for eye scanning.

CAUTION

This machine should be used in compliance with law. Some jurisdictions restrict certain uses, such as gender determination.

Frequency of Use Daily (Typically 8 hours)

Operator Profile •

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

•

The operator must have read and understood the user manual.

Prescription Device CAUTION: United States law restricts this device to sale or use by, or on the order of a physician.

Venue 50 – Basic User Manual Direction 5446729-100 English Rev. 7

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Introduction/Safety

Owner Responsibility

Owner requirements It is the responsibility of the owner to ensure that anyone operating the system reads and understands this section of the manual. However, there is no representation that the act of reading this manual renders the reader qualified to operate, inspect, test, align, calibrate, troubleshoot, repair or modify the system. The owner should make certain that only properly trained, fully-qualified service personnel undertake the installation, maintenance, troubleshooting, calibration and repair of the equipment. The owner of the ultrasound unit should ensure that only properly trained, fully qualified personnel are authorized to operate the system. Before authorizing anyone to operate the system, it should be verified that the person has read, and fully understands the operating instructions contained in this manual. It is advisable to maintain a list of authorized operators. Should the system fail to operate correctly, or if the unit does not respond to the commands described in this manual, the operator should contact the nearest field GE Ultrasound Service Office. For information about specific requirements and regulations applicable to the use of electronic medical equipment, consult the local, state and federal agencies.

CAUTION

For USA only: Federal law restricts this device to use by, or on the orders of, a physician.

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Venue 50 – Basic User Manual Direction 5446729-100 English Rev. 7