Venue 50 User Guide R4.x.x Rev 4

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

2013/10/09

Initial Release

Rev. 2

2013/12/27

Update UI and software functions

Rev. 3

2014/01/15

Update UI

Rev. 4

2014/03/13

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

List of Effective Pages

SECTION NUMBER

REVISION NUMBER

SECTION NUMBER

REVISION NUMBER

Title Page

Rev. 4

Chapter 2

Rev. 4

Revision History

Rev. 4

Chapter 3

Rev. 4

Regulatory Requirements

Rev. 4

Chapter 4

Rev. 4

Table of Contents

Rev. 4

Chapter 5

Rev. 4

Chapter 1

Rev. 4

Index

Rev. 4

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 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).

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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 Indications for Use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3 Frequency of Use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3 Operator Profile - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3 Prescription Device - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3

Owner Responsibility Owner requirements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-4 Notice against user modification- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-5

Safety Precautions Precaution Levels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-6 Hazard Symbols - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-7 Patient Safety- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-9 Equipment and Personnel Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-13 General Caution - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-18 EMC (Electromagnetic Compatibility) - - - - - - - - - - - - - - - - - - - - - - - - 1-19 Patient Environmental Devices- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-26 Acoustic Output - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-28

Device Labels Icon Description - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-31 Warning label locations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-35

Chapter 2 - Getting Started Site Requirements Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-2 Before the system arrives - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-3 Environmental Requirements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-3

Console Overview Console graphics - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-4 Peripheral/Accessory Connection- - - - - - - - - - - - - - - - - - - - - - - - - - - 2-12

Touch Panel Exam Function Controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-14

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Monitor Display Moving the System Moving the System - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-16 When moving the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-17 Transporting the System - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-19

System Start-up Connecting and Using the System - - - - - - - - - - - - - - - - - - - - - - - - - - 2-20

Probes Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-25 Selecting probes- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-25 Connecting the Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-26 Disconnecting the Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-26

Beginning an Exam Home Screen - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-27 Scanning a New Patient - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-28 Scanning without entering any patient data - - - - - - - - - - - - - - - - - - - - 2-28

Chapter 3 - Performing an Exam Optimizing the Image B-Mode Controls- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-2 Color Flow Mode Controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-4 PDI Mode Controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-6 M Mode Controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-7

Measurement and Analysis Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-8 B-Mode Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-9 M-Mode Measurements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-9 Obstetrics Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-10 OB Worksheet - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-10 Clinical Measurement Accuracy - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-11

Chapter 4 - After the Exam is Over Utility Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-2

System Data Features/Specifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-3

Anti-Virus Software Note Venue 50 Security - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-8

System Care and Maintenance Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-10

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Chapter 5 - Probes and Biopsy Probe Overview Probe orientation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-2 Labeling- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-2 Probe Applications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-3 Probe Specifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-4 Probe Slice Thickness Specifications - - - - - - - - - - - - - - - - - - - - - - - - - 5-4 Probe Usage - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-5 Care and Maintenance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-5 Probe Cleaning Process - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-5 Probe Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-6

Biopsy Special Concerns Precautions Concerning the Use of Biopsy Procedures - - - - - - - - - - - - 5-7

Surgery/Intra-operative Use Preparing for Surgery/Intra-operative Procedures - - - - - - - - - - - - - - - - 5-8

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. 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.

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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.

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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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Owner Responsibility Notice against user modification Never modify this product, including system components, software, cables, and so on. User modification may cause safety hazards and degradation in system performance. All modification must be done by a GE qualified person.

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Introduction/Safety

Safety Precautions

Precaution Levels Icon description Various levels of safety precautions may be found on the equipment and different levels of concern are identified by one of the following flag words and icons which precede the precautionary statement.

DANGER

WARNING

CAUTION

NOTE:

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Indicates that a specific hazard is known to exist which through inappropriate conditions or actions will cause: •

Severe or fatal personal injury

•

Substantial property damage

Indicates that a specific hazard is known to exist which through inappropriate conditions or actions may cause: •

Severe personal injury

•

Substantial property damage

Indicates that a potential hazard may exist which through inappropriate conditions or actions will or can cause: •

Minor injury

•

Property damage

Indicates precautions or recommendations that should be used in the operation of the ultrasound system, specifically: •

Maintaining an optimum system environment

•

Using this manual

•

Notes to emphasize or clarify a point

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Safety Precautions Hazard Symbols Icon Description Potential hazards are indicated by the following icons: Table 1-1: Icon

Potential Hazards

Potential Hazard

Usage

Biological Hazard Describes precautions necessary to prevent the risk of disease transmission or infection. • Patient/operator infection due to contaminated equipment

• Cleaning and care instructions • Sheath and glove guidelines

Electrical Hazard Describes precautions necessary to prevent the risk of injury through electric hazards. • Electrical micro-shock to patient, e.g., ventricular

• Probes • ECG, if applicable • Connections to back panel

Moving Hazard Describes precautions necessary to prevent the risk of injury through moving or tipping hazard. • Console, accessories or optional storage devices that can fall on patient, operator, or others • Collision with persons or objects may result in injury while maneuvering or transporting system. • Injury to operator from moving the console

• Moving • Using brakes • Transporting

Acoustic Output Hazard • Patient injury or tissue damage from ultrasound radiation

• ALARA, the use of power output following the ‘as low as reasonably achievable’ principle

Explosion Hazard Describes precautions necessary to prevent the risk of injury through explosion hazard. • Risk of explosion if used in the presence of flammable anesthetics

• Flammable anesthetic

Fire and Smoke Hazard • Patient/operator injury or adverse reaction from fire or smoke • Patient/operator injury from explosion and fire

• Replacing fuses • Outlet guidelines

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Source ISO 7000 No. 0659

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Introduction/Safety Important Safety Considerations The following topic headings (Patient Safety, Equipment and Personnel Safety) are intended to make the equipment operator aware of particular hazards associated with the use of this equipment and the extent to which injury can occur if precautions are not observed. Additional precautions may be provided throughout the manual.

CAUTION

Improper use can result in serious injury. The use of the system outside the described conditions or intended use, and disregarding safety related information is considered abnormal use. The manufacturer is not liable for damage caused by abnormal use of the device. The operator must be thoroughly familiar with the instructions and potential hazards involving ultrasound examination before attempting to use the device. Training assistance is available from GE if needed.

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