Venue 40 User Guide R1.x.x, R2.0.x, R3.x.x Rev 1

Regulatory Requirement Venue 40 complies with regulatory requirements of the following European Directive 93/42/EEC concerning medical devices.

This manual is a reference for the Venue 40. It applies to all versions of the R1.x.x, R2.0.x, R3.x.x software for the Venue 40 ultrasound system.

GE Healthcare

GE Healthcare: Telex 3797371 P.O. Box 414, Milwaukee, Wisconsin 53201 U.S.A. (Asia, Pacific, Latin America, North America) GE Ultraschall: TEL: 49 212.28.02.208 Deutschland GmbH & Co. KG: FAX: 49 212.28.02.431 Beethovenstrasse 239 Postfach 11 05 60 D-42655 Solingen GERMANY

Revision History Reason for Change DATE (YYYY/MM/DD)

REV Rev. 1

2013/03/28

REASON FOR CHANGE Initial Release

List of Effective Pages

PAGE NUMBER

REVISION NUMBER

PAGE NUMBER

REVISION NUMBER

Title Page

Rev. 1

Chapter 2

Rev. 1

Revision History

Rev. 1

Chapter 3

Rev. 1

Regulatory Requirements

Rev. 1

Chapter 4

Rev. 1

Table of Contents

Rev. 1

Chapter 5

Rev. 1

Chapter 1

Rev. 1

Index

Rev. 1

Please verify that you are using the latest revision of this document. Information pertaining to this document is maintained on MyWorkshop (GE Healthcare electronic Product Data Management). If you need to know the latest revision, contact your distributor, local GE Sales Representative or in the USA call the GE Ultrasound Clinical Answer Center at 1 800 682 5327 or 1 262 524 5698.

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Regulatory Requirements

Conformance Standards The following classifications are in accordance with the IEC/ EN 60601-1:6.8.1: •

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 I.

According to CISPR 11, •

Equipment is Group 1, Class A ISM Equipment.

•

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

According to IEC60529, the footswitch rate is IP X8 (MKF 2 1S/1S-MED HID GP 26)

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 60601-1-1 Safety requirements for medical electrical systems.

•

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

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IEC/EN 60601-1-4 Programmable electrical medical systems.

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IEC/EN 60601-1-6 (Usability), EN1041 (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.

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IEC 61157 Declaration of acoustic output parameters.

International Organization of Standards (ISO) •

•

Underwriters’ Laboratories, Inc. (UL), an independent testing laboratory. •

•

ISO 10993-1 Biological evaluation of medical devices.

UL 60601-1 Medical Electrical Equipment, Part 1 General Requirements for Safety.

Canadian Standards Association (CSA). •

CSA 22.2, 601.1 Medical Electrical Equipment, Part 1 General Requirements for Safety.

•

NEMA/AIUM Acoustic Output Display Standard (NEMA UD3, 2004).

•

Medical Device Good Manufacturing Practice Manual issued by the FDA (Food and Drug Administration, Department of Health, USA).

•

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

Certifications

Original Documentation •

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The original document was written in English.

Venue 40 – User Guide Direction 5479694-100 English Rev. 1

Country Specific Approval •

JAPAN MHLW Certified Number: 221ABBZX00092000

•

CHINA

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Table of Contents

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

Table of Contents Chapter 1 - Introduction/Safety System Overview Attention - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-2 Indications for Use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3 Contraindication - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3 Prescription Device - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3

Safety Precautions Precaution Levels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-4 Hazard Symbols - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-5 Patient Safety- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-7 Equipment and Personnel Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-11 General Caution - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-14 Device Labels- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-15 EMC (Electromagnetic Compatibility) - - - - - - - - - - - - - - - - - - - - - - - - 1-19 Patient Environmental Devices- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-26 Acoustic Output - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-28 Warning label locations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-31

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 Control Panel Map - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-13 Stylus - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-14 Monitor Display- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-16

Moving the System Moving the System - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-18 Transporting the System - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-19

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

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Probes Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-24 Selecting probes- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-24 Connecting the Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-25 Disconnecting the Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-25

Beginning an Exam Patient Screen - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-26 Scanning a New Patient - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-27 Scanning without entering any patient data - - - - - - - - - - - - - - - - - - - - 2-27

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

Measurement and Analysis Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-4 B-Mode Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-5 M-Mode Measurements (R2.0.x, R3.x.x only) - - - - - - - - - - - - - - - - - - - 3-5 Obstetrics Measurements (R3.x.x only)- - - - - - - - - - - - - - - - - - - - - - - - 3-6 OB Worksheet (R3.x.x only)- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-6 Clinical Measurement Accuracy - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-7 Setting up the Off-Line Paper Printer - - - - - - - - - - - - - - - - - - - - - - - - - 3-9

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

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

System Care and Maintenance Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-7

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

Interventional Use Preparing for Interventional Procedures - - - - - - - - - - - - - - - - - - - - - - - 5-8

Index

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Chapter 1 Introduction/Safety This chapter consists of information concerning indications for use/contraindications, how this documentation is organized. Also includes 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 40 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.

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System Overview Indications for Use The Venue 40 is intended for use by a qualified physician for ultrasound evaluation. Specific clinical applications and exam types include:

NOTE:

CAUTION

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Fetal/OB

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Abdominal

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GYN

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Urology

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Pediatric

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Small Organ (including breast, testes and thyroid)

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Neonatal Cephalic

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Adult Cephalic (Transcranial)

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Cardiac (including Adult and Pediatric)

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Peripheral Vascular

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Musculoskeletal Conventional

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Musculoskeletal Superficial

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Thoracic (fluid, Pleural and motion detection)

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Interventional guidance

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Non vascular (including Nerve Block)

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Intraoperative

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Transvaginal*

* R3.x.x only. This machine should be used in compliance with law. Some jurisdictions restrict certain uses, such as gender determination.

Contraindication The Venue 40 ultrasound system is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye.

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

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

• Patient/user infection due to contaminated equipment.

• Cleaning and care instructions • Sheath and glove guidelines

• Electrical micro-shock to patient, e.g., ventricular

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

• Patient injury or tissue damage from ultrasound radiation.

• ALARA, the use of Power Output following the ‘as low as reasonably achievable’ principle

• Risk of explosion if used in the presence of flammable anesthetics.

• Flammable anesthetic

• Patient/user injury or adverse reaction from fire or smoke. • Patient/user 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, and Equipment and Personnel Safety) are intended to make the equipment user 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 user 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 Medical Systems if needed. The equipment user is obligated to be familiar with these concerns and avoid conditions that could result in injury.

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Safety Precautions Patient Safety Related Hazards

WARNING

The concerns listed can seriously affect the safety of patients undergoing a diagnostic ultrasound examination.

Patient identification Always include proper identification with all patient data and verify the accuracy of the patient's name and ID numbers when entering such data. Make sure correct patient ID is provided on all recorded data and hard copy prints. Identification errors could result in an incorrect diagnosis. If the Venue 40 needs to be sent for repair, ensure that any patient information is erased from the storage device. In case that any patient information is still residing on the Venue 40, GE will contact the customer and request for urgent collection of that patient information. GE will keep this patient information in a secure environment for a maximum period of 1 month. All patient information will be permanently deleted at that point. If PHI (Patient Healthcare Information) data needs to be sent to GE employees for service purposes, GE will ascertain agreement from the customer. The patient information shall only be transferred by approved service processes, tools and devices restricting access, protecting or encrypting data where required, and providing traceability in the form of paper or electronic documents at each stage of the procedure while maintaining compliance with cross-border restrictions information transfers.

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Introduction/Safety Related Hazards (continued) Diagnostic information Equipment malfunction or incorrect settings can result in measurement errors or failure to detect details within the image. The equipment user must become thoroughly familiar with the equipment operation in order to optimize its performance and recognize possible malfunctions. Applications training is available through the local GE representative. Added confidence in the equipment operation can be gained by establishing a quality assurance program.

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CAUTION

Allowing the machine to transmit acoustic output with the probe not in use (or in its holder) can cause the transducer to build up heat.

CAUTION

The system provides calculations (e.g estimated fetal weight) and charts based on published scientific literature. The selection of the appropriate chart and clinical interpretation of calculations and charts are the sole responsibility of the user. The user must consider contraindications for the use of a calculation or chart as described in the scientific literature. The diagnosis, decision for further examinations and medical treatment must be performed by qualified personnel following good clinical practice.

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Safety Precautions Related Hazards (continued) Mechanical hazards The use of damaged probes can result in injury or increased risk of infection. Inspect probes often for sharp, pointed, or rough surface damage that could cause injury or tear protective barriers. Become familiar with all instructions and precautions provided with special purpose probes. Electrical Hazard

A damaged probe can also increase the risk of electric shock if conductive solutions come in contact with internal live parts. Inspect probes often for cracks or openings in the housing and holes in and around the acoustic lens or other damage that could allow liquid entry. Become familiar with the probe's use and care precautions outlined in Probes and Biopsy.

CAUTION

Ultrasound transducers are sensitive instruments which can easily be damaged by rough handling. Take extra care not to drop transducers and avoid contact with sharp or abrasive surfaces. A damaged housing, lens or cable can result in patient injury or serious impairment or operation.

CAUTION

Ultrasound can produce harmful effects in tissue and potentially result in patient injury. Always minimize exposure time and keep ultrasound levels low when there is no medical benefit. Use the principle of ALARA (As Low As Reasonably Achievable), increasing output only when needed to obtain diagnostic image quality. Observe the acoustic output display and be familiar with all controls affecting the output level. See the Bioeffects section of the Acoustic Output chapter in the Advanced Reference Manual for more information.

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Introduction/Safety Related Hazards (continued) Training It is recommended that all users receive proper training in applications before performing them in a clinical setting. Please contact the local GE representative for training assistance. ALARA training is provided by GE Application Specialists. The ALARA education program for the clinical end-user covers basic ultrasound principles, possible biological effects, the derivation and meaning of the indices, ALARA principles, and examples of specific applications of the ALARA principle.

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