GE Healthcare VSCANEXTEND User Manual

Technical Publications

Vscan Extend™

Version 1.0

User Manual

5721203-100 — English

Rev. D

Regulatory requirement

This product complies with regulatory requirements of the following European Directive 93/42/EEC concerning medical devices.

This manual is a reference for the Vscan Extend. It applies to all versions of the 1.0 software for the Vscan Extend ultrasound system.

Manufacturer:

GE VINGMED ULTRASOUND A/S Strandpromenaden 45 3191 Horten, Norway Tel.: (+47) 3302 1100 Fax: (+47) 3302 1350

Revision History

Reason for Change

DATE

REV

Rev. A 2016/04/05 Initial draft Rev. B 2016/05/19 Included External Battery charger label

Rev. C 2016/06/01 Removed breast and testes from indication of use

Rev. D 2016/08/18 Included IP33, Ophthalmic and Aorta presets, IEC

(YYYY/MM/DD)

Included Power button under device labels Included revised rating label Included sections in Privacy and Security chapter

statement Included the revised rating label, battery label and external charger label Included the scope for all the standards in Table i-1

60601-11 and 12 standards, Tricefy App

REASON FOR CHANGE

Please verify that you are using the latest revision of this document. Information pertaining to this document is maintained on ePDM (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 GE product families are tested to meet all applicable requirements in relevant EU Directives and European/ International standards. Any changes to accessories, peripheral units or any other part of the system must be approved by the manufacturer: GE Medical Systems. Ignoring this advice may compromise the regulatory approvals obtaine d for the product.

This product complies with the regulatory requirement of the following:

Table i-1: Regulatory Requirements

Standard/Directive Scope

93/42/EEC Medical Devices Directive (MDD)

2007/47/EC (MDD amendment) Directive 2011/65/EU RoHS 2002/96/EC WEEE 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.

EN55011 Industrial, scientific and medical equipment -

Radio-frequency disturbance characteristics - Limits and methods of measurement

IEC* 60601-1 CAN/CSA-C22.2 No 601.1

IEC* 60601-2-37 Medical electrical equipment - Part 2-37. Particular

IEC* 60601-1-2 Medical Electrical Equipment - part 1-2. Collateral standard:

IEC* 60601-1-4 Medical Electrical Equipment - part 1-4. Collateral standard:

IEC* 60601-1-6 Medical Electrical Equipment - part 1-6. Collateral standard:

NEMA/AIUM UD-3 Standard for real-time display of thermal and mechanical

Medical Electrical Equipment, Part 1; General Requirements for Safety

requirements for the safety of ultrasonic medical diagnostic and monitoring equipment

Electromagnetic compatibility - Requirements and tests.

Programmable electrical medical systems

Usability.

acoustic output indices on diagnostic ultrasound equipment.

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Table i-1: Regulatory Requirements (Continued)

Standard/Directive Scope

ISO10993-1 Biological evaluation of medical devices EN 300 328 Electromagnetic compatibility and Radio spectrum Matters

ISO 14971 Medical devices - Application of risk management to medical

IEC* 62304 Medical device software - Software life-cycle processes IEC* 62366 Medical devices - Application of usability engineering to

IEC* 60601-1-11 Requirements for medical electrical equipment and medical

IEC* 60601-1-12 Requirements for medical electrical equipment and medical

* including national deviations

(ERM); Wideband transmission systems

devices

medical devices

electrical systems used in the home healthcare environment

electrical systems intended for use in the emergency medical services environment

Certifications

• GE Vingmed Ultrasound is ISO 13485 certified.

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Classifications

Class II Equipment

The following classifications are in accordance with the IEC/ EN 60601-1.

Type and degree of protection against electric shock:

• Vscan Extend has an internal battery which allows the operation during AC power absence.

• The AC adapter is Class II.

• Vscan Extend has type BFApplied Part.

Vscan Extend main unit is rated IP33:

• 3: Protected against solid foreign objects of 2,5 mm Ø and greater.

• 3: Protected against spraying water.

Vscan Extend probe (immersible portion) is IPX7.

EQUIPMENT in which protection against electric shock does not rely on BASIC INSULATION only, but in which additional safety precautions such as DOUBLE INSULATION or REINFORCED INSULATION are provided, there being no provision for protective earthing or reliance upon installation conditions.

Type BF Applied part

TYPE BF APPLIED PART providing a specified degree of protection against electric shock, with particular regard to allowable LEAKAGE CURRENT.

Table i-2: Leakage Current

Normal mode Single fault condition

Patient leakage current <100 microA <500 microA

Original Documentation

• The original document was written in English.

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Country Specific Approval

• USA AND TERRITORIES

DANGER

• JAPAN

DANGER

• CHINA

DANGER

Importer Information

Turkey

The following optional feature IS NOT available in the USA and its territories:

– Ophthalmalic

The following optional feature IS NOT available in JAPAN: – Ophthalmalic

The following optional feature IS NOT available in CHINA: – Ophthalmalic

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Conformance Standards - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-3 Certifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-4 Classifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-5 Class II Equipment - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-5 Type BF Applied part - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-5 Original Documentation- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-5 Country Specific Approval - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-6 Importer Information - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-6

Table of Contents Chapter 1 — Introduction

Overview

Attention - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-2 General description- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-2 Principles of operation- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3 Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3 Intended use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3 Indications for use (for all countries except USA, China and Japan)- - - - 1-4 Indications for use (for USA, China and Japan) - - - - - - - - - - - - - - - - - - 1-5 Contraindication for use (for USA, China and Japan) - - - - - - - - - - - - - - 1-5 Intended users - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-6 Prescription Device- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-6 Operator profile - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-6

Warnings

Important Safety Considerations - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-7

Contact Information

Contacting GE Ultrasound - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-10 Global ultrasound support center phone numbers - - - - - - - - - - - - - - - 1-11 Manufacturer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-14

Chapter 2 — Safety

Introduction

Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-2

Owner responsibility

Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-3 Notice against user modification- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-4

Important safety considerations

Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-5 Patient Safety- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-5 Diagnostic information- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-6

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General precautionary advice for the use of diagnostic ultrasound in

combination with ultrasound contrast agents - - - - - - - - - - - - - - - - - 2-6 Mechanical hazards - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-6 Electrical hazard- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-7 Personnel and equipment safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-7 Explosion hazard - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-7 Electrical hazard- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-8 Electromagnetic Compatibility (EMC) - - - - - - - - - - - - - - - - - - - - - - - - 2-10 Electromagnetic emissions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-14 Electromagnetic immunity - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-14 Separation distances- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-18 Essential Performance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-18 Acoustic output- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-19 Environmental protection- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-23

Maximum probe temperature Device labels and symbols

Vscan Extend Labels (Example)- - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-25 Explanation of the Pollution control label for China- - - - - - - - - - - - - - - 2-29

Chapter 3 — Preparing Vscan Extend for Use

Package contents

Vscan Extend package contents - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-2

Environmental requirements

Environmental requirements for the device - - - - - - - - - - - - - - - - - - - - - 3-3

System description

System overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-4 Accessories and Configurations- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-7 External battery charger compartment (option) - - - - - - - - - - - - - - - - - 3-11 Display screens - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-12

Vscan Extend Battery

Battery- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-15

Initial use

First time use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-22 Power on/off- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-22 Vscan Extend activation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-24

Chapter 4 — Vscan Extend Settings

Settings

Scan Settings- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-2 Server Settings- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-3 Diagnostics - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-12 System Settings - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-13 Administrator Access - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-15 Storage Access - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-17 Wi-Fi - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-21 Configuring Wi-Fi - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-23 MDM Installation Procedures (Optional) - - - - - - - - - - - - - - - - - - - - - - 4-24 Certificate Authority- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-28 GE Marketplace - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-31

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Chapter 5 — Using Vscan Extend

Scanning

General scanning recommendations- - - - - - - - - - - - - - - - - - - - - - - - - - 5-2 Black and white imaging - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-17 Color imaging- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-20 Auto freeze - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-23 AutoCycle - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-23 Use of sterile sheath - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-23

Measurements

Taking measurements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-24

Review and recall of stored data

Backups Recommended - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-26 Reviewing and recalling images or videos from an exam list- - - - - - - - 5-26 Deletion of data - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-28 Data Export - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-30 Backup - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-42 Restore - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-45

Using Vscan Extend Apps

Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-47 Bladder Volume - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-47 Lung Protocol- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-54 Tricefy - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-62

Chapter 6 — Vscan Extend Maintenance

System care and maintenance

Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-2 Inspection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-3

Cleaning and disinfection

Cleaning the device - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-4 Method of cleaning: Manual- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-6 Disinfecting the device - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-7 Disinfecting the probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-9 Rinsing and Lubricating Agents - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-11

Upgrade software

Scanner software - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-12

Troubleshooting

Vscan Extend troubleshooting - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-14 System Warning Messages - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-16

Chapter 7 — Appendix

Specifications

Dimension and weight- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-2 Phased array transducer for deep scanning - - - - - - - - - - - - - - - - - - - - 7-2 Linear transducer for shallow scanning- - - - - - - - - - - - - - - - - - - - - - - - 7-2

Acoustic Output Reporting Tables

Definitions, symbols and abbreviations - - - - - - - - - - - - - - - - - - - - - - - - 7-3 Acoustic Output Reporting Tables for Track 3/EN/IEC 60601-2-37 - - - - 7-6

Measurement accuracy

Basic Measurements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-12

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Chapter 8 — Privacy and Security

Introduction

Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-2 How to contact GE - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-2 Privacy and Security Environment - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-3

Network Connectivity

Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-6 System interconnections - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-6 Network Requirements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-8 Network Protocols- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-8

Information Protection

Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-9 Network Security - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-9

System Protection

Vscan Extend – system protection - - - - - - - - - - - - - - - - - - - - - - - - - - 8-16

Personal Information Collected by the Product

Information collection and use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-17 Manual information collection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-18 Information disclosure - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-19 Retention and destruction of personal information - - - - - - - - - - - - - - - 8-19 Potential Hazardous Situations Resulting From Failures of the IT Network- -

8-21

Index

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Chapter 1

Introduction

Contents: ‘Overview’ on page 1-2 ‘Warnings’ on page 1-7 ‘Contact Information’ on page 1-10

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Introduction

Attention

Overview

This manual covers the following two configurations of the Vscan Extend. Refer to the relevant section based on the configuration purchased.

• Vscan Extend deep scanning (holding the phased array transducer G3S)

• Vscan Extend deep and shallow scanning (holding the phased array transducer G3S and the linear array transducer G8L)

Vscan Extend is a trademark of General Electric Company.

configured with a sector probe allowing

configured with a Dual Probe allowing

General description

Vscan Extend is a pocket-sized, battery powered general purpose diagnostic ultrasound system. The system consists of a handheld unit with a 5 inch touch screen display and a permanently attached probe.

The battery can be charged either in the system or alone. The system is capable of transferring images wirelessly to a DICOM server or via Windows Share. Data can also be exported to a standard PC using a wired USB export.

Capabilities also include access to GE Marketplace, which allows the user to download Bladder Volume, Lung Protocol, Barcode Reader and Interface to Case Exchange Software Apps.

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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 probe. The mechanical ultrasound waves spread through the body, producing an echo where density changes occur. The echoes return to the probe where they are converted back into electrical signals.

These echo signals are 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.

A probe is an accurate, solid-state device, providing multiple image formats. The digital design and use of solid-state components provides highly stable and consistent imaging performance with minimal required maintenance.

Safety

Overview

Intended use

Read and understand all instructions in the User's Manual before attempting to use the ultrasound unit. Keep the manual with the equipment at all time. Periodically review the procedures for operation and safety precautions.

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Introduction

Indications for use (for all countries except USA, China and Japan)

Vscan Extend is a general purpose diagnostic ultrasound imaging system for use by qualified and trained healthcare professionals enabling visualization and measurement of anatomical structures and fluid. It's pocket-sized portability and simplified user interface enables integration into examination and training sessions indoors and in other environments described in the user manual. The information can be used for basic/focused assessments and adjunctively wi th othe r m ed ica l data for clinical diagnosis purposes during routine, periodic monitoring, and triage.

With the phased array transducer on the sector probe, the specific clinical applications and exam types include: Cardiac; Abdominal; Renal; OB/GYN; Urology; Fetal, Evaluation of Presence of Fluid; Imaging Guidance for Needle/Catheter Placement (e.g. paracentesis, pericardiocentesis, thoracentesis, amniocentesis); Peripheral Vascular Imaging (e.g. arteries and veins); Thoracic/Lung (e.g. pleural motion/sliding, line artifacts); Adult Cephalic; and Pediatrics.

With the addition of the linear array transducer on the single dual headed probe solution, the specific clinical applications and exam types are expanded to include: Peripheral vascular imaging (e.g. lower extremity, carotid); Procedure Guidance for Arterial or Venous Vessels (e.g. central lines, upper extremity); Small Organs (e.g. thyroid); Musculoskeletal (Long Bone; Hip, shoulder, elbow and Knee Joints); Evaluation of Presence of Fluid; Thoracic/Lung (e.g. pleural motion/sliding, line artifacts); Ophthalmic*; and Pediatrics.

WARNING

*Ophthalmic use is provided as an option. Ophthalmic scanning MUST only be used with the linear functionality of th e Dual Probe.

If the Vscan Extend purchased does NOT have the Ophthalmic preset option, DO NOT use for ophthalmic use or any use causing the acoustic beam to pass through the eye.

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Indications for use (for USA, China and Japan)

Overview

Contraindication for use (for USA, China and Japan)

The Vscan Extend ultrasound device is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye.

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Introduction

Intended users

Prescription Device

Operator profile

Vscan Extend is intended to be used by qualified and trained healthcare professionals that are legally authorized by law in the country, state or other local municipality in which he pr actice s to use the device. The list of the potential users includes but is not limited to (based on title/geographical location): primary care physicians, point-of-care users, sonographers, medical healthcare technicians, nurses, midwives, paramedics, nurse practitioner, physician assistants, medical students.

The users may or may not be working under supervision or authority of a physician.

For USA only: CAUTION: Federal law restricts this device to sale by or on the

order of a physician.

CAUTION

Qualified and trained healthcare professionals with at least a basic level of general ultrasound training that includes limited image acquisition techniques and interpretation (i.e. po sition the probe correctly on the patient and determine at least normal vs. abnormal anatomy views during scanning).

The operator must read and understand the user manual.

Contact GE sales representative fo r product training assistance and visit the Vscan web portal for reference materials.

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Important Safety Considerations

To prevent damage of the equipment or injury to your self or others, read the following safety warnings before using Vscan Extend.

Warnings

WARNING

• Vscan Extend is a precision instrument. Handle Vscan Extend and its accessories with care. Do not subject Vscan Extend to mechanical shock or impact.

• Do not attempt to disassemble or alter any part of the unit including the probe, the battery, the AC/DC adapter and accessories. Disassembly or modification may result in electrical shock.

• Stop using the unit if it emits smoke or noxious fumes. Failure to do so may result in electrical shock or fire.

• Stop using the unit if the casing is damaged, including the probe. Failure to do so may result in electrical shock.

• Do not use the device if the gorilla glass is broken.

• Do not use the AC/DC adapter if showing visible damages.

• Use only the designated power accessories (battery and charger). Failure to do so may result in electrical shock or fire.

• Do not place the battery near a heat source or expose it to direct flame. Such exposure may lead to corrosive liquid leakage, electrical shock or fire.

• To reduce risk for electrical shock, do not plug or unplug the AC/DC adapter from mains socket with wet hands.

• Avoid dropping or subjecting the unit, including the probe, the battery and accessories to severe impacts. This could result in electrical shock, corrosive liquid leakage and injury.

• Keep good hand contact with Vscan Extend during scanning to avoid heating up of the unit and termination of scan due to built-in temperature limits.

• At times, user may be required to enter PIN to save patient data. It is extremely important to remember this PIN in order to avoid loss of patient data in case of entering wrong PIN multiple times or if the user forgets the PIN.

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Introduction

Important Safety Considerations (continued)

WARNING

• Do not short-circuit the battery terminal with metallic objects. This may result in overheating and burns.

• Do not store or carry a battery loosely with metallic devices.

• Disconnect the battery charger when not in use to avoid fire hazard.

• Keep the charger dry. Failure to observe this precaution may result in fire and electric shock

• Keep this unit out of reach of children. Strangulation resulting from baby or child entanglement in probe cable may occur.

Before charging or using a battery it is important that you read and understand the battery safety and environment information.

• Do not damage the rechargeable battery. A damaged battery can cause an explosion or fire, and can re su lt in personal injury and/or property damage. To prevent injury or damaged do not use or charge the battery if it appears to be damaged. Signs of damage include, but are not limited to, discoloration, warping, and leaking batt er y fluid . Do no t expose the battery to fire, high temperature, or direct sunlight. Do not immerse or expose the battery to water. Do not use or store the battery inside a vehicle during hot weather. Do not drop or puncture the battery. Do not open the battery or short-circuit its contacts.

WARNING

Avoid contact with the rechargeable battery if it appears to be leaking. Battery fluid is corrosive, and contact with it can result in personal injury and/or property damage.

To prevent injury or damage:

• If the battery leaks, avoid contact with the battery fluid. If any liquid from the battery should come in contact with the eye, immediately wash the eye with plenty of water and seek medical advice as soon as possible. Do not rub your eyes!

• If battery fluid gets onto your skin or clothing, immediately use clean water to wash off the battery fluid.

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Important Safety Considerations (continued)

Warnings

WARNING

CAUTION

Charge and use the rechargeable battery only in strict accordance with the instructions. Charging or using the battery in unauthorized equipment can cause an explosion or fire, and can result in personal injury and/or equipment damage.

To prevent injury or damage:

• Do not charge or use the battery if it appears to be damaged or leaking.

• Charge the battery only in a Vscan Extend device or in the Vscan Extend battery charger. Be sure to follow all instructions that are provided with the battery charger.

• Discontinue charging a battery that gives off extreme heat or a burning odor.

• Use the battery only in the Vscan Extend.

• Use the battery only for its intended use and according to the instructions in the product documentation.

• Ensure to backup data regularly and to erase the data before sending the Vscan Extend for service.

• To access or add patient information, a device pin is required. Ensure not to lose the pin.

CAUTION

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Vscan Extend cannot be sterilized. Apply a sterile sheath if the device is going to be used in an application where a higher degree of cleanliness is required. The sheath should cover the probe and any part of the probe cable that might come in contact with the area requiring higher cleanliness.

Introduction

Contacting GE Ultrasound

For additional information or assistance, please contact your local distributor or the appropriate support resource listed on the following pages:

Internet

https://vscan.gehealthcare.com http://www.gehealthcare.com

USA

Contact Information

Clinical Questions

Service Questions

TEL: (1) 800-437-1171 Ultrasound Service Engineering 9900 Innovation Drive Wauwatosa, WI 53226

Please contact your local Applications or Sales Representative.

For service contact your local Service Representative.

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Accessories Catalog Requests

To request the latest GE Accessories catalog or equipment brochures in the United St ates, call the Response Center

TEL: (1) 800-643-6439 In other locations, contact your local Applications, Sales or

Service Representative.

Placing an order

To place an order, order supplies or ask an accessory-related question in the United States, call the GE Access Center

TEL: (1) 800-472-3666 In other locations, contact your local Applications, Sales or

Service Representative.

Global ultrasound support center phone numbers

For countries not listed in the tables below, please contact the local distributor.

Contact Information

When contacting Support you will have to provide your system ID. If the system ID is unknown, please give the Temporary System ID “Vscan Extend” to be properly routed for support.

Americas

Table 1-1: Americas

Region Telephone

United States Canada 800-668-0732 Mexico 0800 9043400 Puerto Rico 0800 4371171 Brazil 0800 122345 Argentina 0800 3331984 Chile 0800 367000

For USA only: when contacting GE CARES you will have to provide your system ID. If system ID is

unknown, please give the Temporary System ID “Vscan Extend” to be properly routed for support.

800-437-1171

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Introduction

Europe, Middle East and Africa

Table 1-2: Europe, Middle East and Africa

Region Telephone

Algeria +21321484612 Andorra 902 400 246 Austria 0800244260 Belgium Dutch +32 262 638 38 Belgium French +32 262 638 39 Bulgarian +35929712040 Denmark 80404944 Egypt +202 19434 [hot line] Finland 0981710182 France 0800139140 G. D. Luxembourg 080022973 Germany 08004373784 Greece 302109690660 Holy See 800 827168 Hungary +36-23-410-510 Ireland 1800992557 Israel Contact local distributor Italy Central 800 827168 Italy North-East 800 827166 Italy North-West 800 827164 Italy South 800 827170 Liechtenstein 0041 44 809 9293 Monaco 0800139140 Netherlands 8000994442 Northern Ireland 08000720248 Norway 80062043 Portugal 800 834 004 Russia +7 495 739 69 75 San Marino 800 827168

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Table 1-2: Europe, Middle East and Africa (Continued)

Region Telephone

Saudi Arabia 800 1243002 South Africa 800 111 671 Spain 902 400 246 Sweden 0201201436 Switzerland 0800556958 Turkey Contact local distributor UAE 800 3646 UK 0845 8503392 Ukraine +38 044 391 37 56 (57)

Contact Information

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Introduction

Asia and Pacific

Table 1-3: Asia and Pacific

Region Telephone

China 8008108188 Hong Kong (852) 21006288 Taiwan 0800-021-770 India (91) 1800-425-8025 Singapore (65) 62773444 Australia 1-800-659-465 New Zealand 0800 65 94 65 Japan 0120-055-919 Korea (82) 2-1544-6119 Bangladesh (880) 29135488 Sri Lanka (94) 114891178 Bhutan Contact GE India Maldives Contact GE India Nepal Contact local distributor Malaysia 1800 88 3911 Thailand (66) 26248400 Vietnam Contact local distributor Philippines Contact local distributor Indonesia Contact local distributor Laos Contact local distributor Brunei Darussalam Contact local distributor Cambodia Contact local distributor

Manufacturer

GE VINGMED ULTRASOUND A/S Strandpromenaden 45 3191 Horten, Norway TEL: (+47) 3302 1100; FAX: (+47) 3302 1350

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Chapter 2

Safety

Contents: ‘Introduction’ on page 2-2 ‘Owner responsibility’ on page 2-3 ‘Important safety considerations’ on page 2-5 ‘Maximum probe temperature’ on page 2-24 ‘Device labels and symbols’ on page 2-25

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Safety

Overview

Introduction

This chapter describes the important safety measures which should be taken before operating the Vscan Extend. Procedures for simple care and maintenance of the Vscan Extend are also described.

Various levels of safety precautions may be foun d on the equipment, and different levels of severity are identified by one of the following icons that precede precautionary statements in the text.

The following icons are used to indicate pr ec au tio ns :

DANGER

WARNING

CAUTION

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.

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Overview

Owner responsibility

It is the responsibility of the owner to ensure that anyone operating Vscan Extend 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 undert ake maintenance of the equipment. There are no user serviceable parts in the system or accessories. If servicing is required, contact GE. See ‘Contact Information’ on page 1-10 for more information.

The owner of Vscan Extend 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 Vscan Extend 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.

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Safety

Overview (continued)

The owner of Vscan Extend MUST be aware of the data protection policies while configuring the DICOM and Windows Share servers. GE is not responsible for data sharing. Bef ore configuring the servers, the owner of the Vscan Extend MUST abide by the applicable privacy acts specific to their region or country.

CAUTION

For USA only: Federal law restricts this device to sale by or on the order of a

physician.

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

Notice against user modification

Never modify this product, including system components, 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.

Software upgrade following GE recommendations can be done by the user.

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