GE Healthcare VSCANEXTEND User Manual

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Technical Publications

Vscan Extend™

Version 1.0

User Manual

5721203-100 — English

Rev. D

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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

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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

Vscan Extend – User Manual 1-9 5721203-100 Rev. D

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.

Page 22

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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Overview

Important safety considerations

This section includes considerations for the following:

• Patient safety

• Personnel and equipment safety

The information contained in this section is intended to familiarize the user with the hazards associated with the use of Vscan Extend, and to alert them to the extent to which injury and damage may occur if the precautions are not observed.

Users are obligated to familiarize themselves with these safety considerations and to avoid conditions that could result in injury or damage.

Patient Safety

Patient identification

WARNING

CAUTION

The concerns listed in this section can seriously affect the safety of the patient undergoing a diagnostic ultrasound examination.

Always include proper identification with all patient data. Identification errors could result in an incorrect diagnosis.

If the Vscan Extend needs to be sent for repair, ensure that the patient information is backed up and confirm backup was successful. The patient information MUST be erased from internal memory (See ‘Backup’ on page 5-42 for more information.) before shipping.

To access or add patient information, a device pin is required. Retain the 4-digit pin in a safe location to prevent loss of the pin. Avoid sharing the PIN. See ‘Administrator Access’ on

page 4-15 for more information.

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Safety

Diagnostic information

The images and calculations provided by the system, including bladder volume and lung protocol, are intended for use by competent users, as a diagnostic tool. They are not to be explicitly regarded as the sole, irrefutable basis for clinical diagnosis. Users are encouraged to study the literature and reach their own professional conclusions regarding the clinical use of the system.

The user should be aware of the product specifications and of the system accuracy and stability limitations. These limitations must be considered before making any decisio n ba sed on quantitative values. If in doubt, the nearest GE Ultrasound Service Office should be consulted.

Equipment malfunction or incorrect settings can result in measurement errors or failure to detect detail s in the image. The user must become thoroughly familiar with the operation of the Vscan Extend in order to optimize its performance and to recognize possible malfunctions.

CAUTION

Avoid reflections from windows/lamps/direct sunlight on the display. Avoid analyzing data from small viewing angles.

General precautionary advice for the use of diagnostic ultrasound in combination with ultrasound contrast agents

CAUTION

The Vscan Extend is not intended to be used with a contrast agent. Cardiac rhythm disturbances during cardiac studies using gas ultrasound contrast agents have been observed in the diagnostic range of Mechanical Index (MI) values. See the specific package insert for the contrast agent being used for further details.

Mechanical hazards

A damaged probe may result in injury or increased risk of contamination. Inspect the probe frequently for sharp, pointed or rough surface damage that could cause injury or tear protective barriers (gloves and sheaths).

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Electrical hazard

A damaged probe may increase the risk of electric shock if conductive solutions come in contact with internal electronics. Inspect the probe often for cracks or openings in the housing and holes in and around the acoustic lens, or other damag e that could allow moisture to enter. Become familiar with the probe's care precautions outlined in ‘Inspecting the Vscan Extend’ on page 6-3.

Personnel and equipment safety

Important safety considerations

DANGER

Explosion hazard

The hazards listed below can seriously affect the safety of personnel and equipment during a diagnostic ultrasound examination.

Never operate the equipment in the presence of flammable or explosive liquids, vapors or gases. Malfunctions in the Vscan Extend, or sparks, can electrically ignite these substances. Operators should be aware of the following points to prevent such explosion hazards.

• If flammable substances are detected in the environment, do not plug in or turn on the system.

• If flammable substances are detected after the system has been turned on, do not attempt to turn of f the Vscan Exten d, or to unplug it.

• If flammable substances are detected, evacuate and ventilate the area before turning off Vscan Extend.

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Safety

Electrical hazard

WARNING

NOTE: Any rest energy within our scanners or their components will be

To avoid injury

Pacemaker hazard

The internal circuits of the AC/DC adapter use high voltages, capable of causing serious injury or death by electrical shock.

below 60 V DC or 2 mJ.

• Do not remove the Vscan Extend’s protective covers. No user-serviceable parts are inside. If servicing is required, contact GE service.

• Conductive fluids seeping into the active circuit components may cause short circuiting, which could result in an electrical fire.

The possibility of the system interfering with pacemakers is minimal. However, as this system generates high frequency electrical signals, the operator should be aware of the potential hazard this could cause.

Electrical Safety

Device classifications

Vscan Extend is an internally powered device, type BF. The AC/DC adapter is Class II.

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External Connection

Important safety considerations

CAUTION

1. Patient environment

Connection to a PC can be done when the PC is in compliance with the EN/IEC 60950 (Data processing equipment).

The computer connected to Vscan Extend must be kept outside the patient environment (refer to local regulation and EN/ES/IEC 60601-1).

Figure 2-1. Patient environment

Allergic reactions to latex-containing medical devices

Due to reports of severe allergic reactions to medical devices containing latex (natural rubber), the FDA advises healthcare professionals to identify latex-sensitive patients, and be prepared to treat allergic reactions promptly. Latex is a component of many medical devices, including surgical and examination gloves, catheters, incubation tubes, anesthesia masks and dental dams. Patient reaction to latex has ranged from contact urticaria, to systemic anaphylaxis.

For more details regarding allergic reaction to latex, refer to FDA Medical Alert MDA91-1, March 29.

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Safety

Electromagnetic Compatibility (EMC)

NOTE: This unit carries the CE mark. It complies with regulatory

requirements of the European Directive 93/42/EEC concerning medical devices. It also complies with emission limits for a Group 1, Class B Medical Device as stated in EN/ IEC 60601-1-2.

Electrical medical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this manual.

AII types of electronic equipment may characteristically cause electromagnetic interference with other equipment, transmitted either through air or connecting cables. The term Electromagnetic Compatibility (EMC), indicates the capability of the equipment to curb electromagnetic influence from other equipment, while at the same time not affecting oth er equipment with similar electromagnetic radiation.

Radiated or conducted electromagnetic signals can cause distortion, degradation, or artifacts in the ultrasound image which may impair the ultrasound unit’s essential performance (see ‘Electrical Safety’ on page 2-8).

There is no guarantee that interference will not occur in a particular installation. If this equipment is found to cause or respond to interference, attempt to correct the problem by one or more of the following measures:

• Re-orient or re-locate the affected device.

• Increase the separation between the unit and the affected device.

• Power the equipment from a source other than that of the affected device.

• Consult the service representative for further suggestions.

The manufacturer is not responsible for any interference or responses caused by the use of interconnecting cables other than those recommended, or by unauthorized changes or modifications to this unit. Unauthorized changes or modifications could void the user's authority to operate the equipment.

To comply with the regulations on electromagnetic interference, all interconnecting cables to peripheral devices must be shielded and properly grounded. Use of cable s no t pr op er ly shielded and grounded may result in the equipment causing or responding to radio frequency interference, in violation of the European Union Medical Device Directive and FCC regulations.

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Important safety considerations

Electromagnetic Compatibility (EMC) (continued)

Devices which intrinsically transmit radio waves such as cellular phones, radio transceivers, mobile radio transmitters, radio-controlled toys, and so on, should preferably not be operated near the unit. See ‘Electromagnetic Compatibility (EMC)’ on page 2-10 about the recommended minimum separation distances between portable and mobile RF communications equipment and th e ult ra so un d unit.

Any electrical device can unintentionally emit electromagnetic waves. However, minimum device separation distances cannot be calculated for such unspecified electromagnetic radiation. When the ultrasound unit is used adjacent to or in close proximity to other equipment the user shou ld be att en tiv e to unexpected device behavior which may be caused by such electromagnetic radiation.

The ultrasound unit is intended for use in the electromagnetic environment specified in the tables below.

The user of ultrasound unit should assure that the device is used in such an environment.

FCC compliance statements

1. This device may not cause harmful interference, and

2. This device must accept any interference received, including Interference that may caus e un de sir ed op er at i on .

FCC Caution!!!

• Any changes or modifications not expressly approved by the party Responsible for compliance could void the user's authority to operate this Equipment

• This equipment should be installed and operated with minimum distance 20 cm between the radiator & your body.

Part 15B compliance statements for digital devices:

NOTE: This equipment has been tested and found to comply with the

limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation.

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Safety

FCC compliance statements (continued)

This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television

Reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct th e interference by one or more of the following measures:

• Increase the separation between the equipment and receiver.

• Connect the equipment into an outlet on a circuit different from that to which the receiver is connected

• Consult the dealer or an experienced radio/TV technician for help.

This Class B digital apparatus complies with Canadian ICES-003.

This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions:

1. This device may not cause interference, and

2. This device must accept any interference, including interference that may cause undesired operation of the device.

FCC compliance statements for Canada (French translation)

Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de licence. L'exploitation est autorisée aux.

deux conditions suivantes:

1. l'appareil ne doit pas produire de brouillage, et

2. l'utilisateur de l'appareil doit accepter tout brouillage adioélectrique subi, même si le brouillage est susceptible d'en compromettre le fonctionnement.

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Important safety considerations

FCC compliance statements for Canada (French translation) (continued)

This equipment complies with radio frequency exposure limit s set forth by Industry Canada for an uncontrolled Environment. This equipment should be installed and operated with minimum distance 20 cm between the device and the user or bystanders.Cet équipement est conforme aux limites d'exposition aux radiofréquences

définies par Industrie Canada pourun environnement non contrôlé. Cet équipement doit être installé et utilisé avec un minimum de 20 cm de distance entre le dispositif et l'utilisateur ou des tiers.

un appareil numérique, en vertu de l’article 15 de la réglementation de la FCC. Ces limites ont été instaurées pour fournir une protection raisonnable contre toute interférence nuisible dans une installation résidentielle. Cet équipement génère, utilise et peut émettre de l’énergie radiofréquence. S’il n’est pas installé et utilisé conformément aux instructions, il peut provoquer des interférences sur les communications radio. Cependant, il n’est pas garanti que des interférences ne se produiront pas dans certaines installations. Si cet équipement cause des interférences à la réception radio ou télévisée (ce qui peut être vérifi é en éteignant l’appareil puis en le remettant sous tension), l’utilisateur peut tenter de les résoudre en suivant une ou plusieurs des mesures ci-après:

• Réorienter ou déplacer l’antenne réceptrice. Augmenter l’espace entre

• l’appareil et le récepteur. Brancher l’appareil à une prise de courant différente de celle sur laquelle le récepteur est branché.

Pour obtenir de l’aide, contacter le vendeur ou un technician radio/télévision expérimenté.

REMARQUE : Toute modifi cation non autorisée expressément par le fabricant responsable de la conformité peut annuler le droit de l’utilisateur à faire fonctionner le produit.

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Safety

Electromagnetic emissions

Table 2-1: Electromagnetic emissions

Guidance and manufacturer’s declaration – electromagnetic emissions.

Emissions test Compliance Electromagnetic environment - guidance

RF emission EN55011

Harmonic emission EN 61000-3-2

Voltage fluctuations/flicker emissions

EN/IEC 61000-3-3

Group 1 Class B

Complies

The Vscan Extend uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

The Vscan Extend is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Electromagnetic immunity

Table 2-2: Electromagnetic immunity (Part 1)

Guidance and manufacturer’s declaration – electromagnetic immunity.

The Vscan Extend is intended for use in the electromagnetic environment below. The

customer or the user of the Vscan Extend should assure that it is used in such an

environment.

Electromagnetic

Immunity test

EN 60601

test level Compliance level

environment –

guidance

Electrostatic discharge (ESD) EN 61000-4-2

Electrical fast transient/ burst EN 61000-4-4

Surge EN 61000-4-5

±6 kV contact ±8 kV air

±2 kV for power-supply lines ±1 kV for input/output lines

±1 kV line(s) to line(s) ±1 kV line(s) to

±6 kV ±8 kV

±2 kV for power-supply lines ±1 kV for input/ output lines

line(s)

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Mains power quality should be that of a typical commercial or hospital environment.

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Important safety considerations

Table 2-2: Electromagnetic immunity (Part 1) (Continued)

Guidance and manufacturer’s declaration – electromagnetic immunity.

The Vscan Extend is intended for use in the electromagnetic environment below. The

customer or the user of the Vscan Extend should assure that it is used in such an

environment.

Electromagnetic

Immunity test

EN 60601

test level

Compliance level

environment –

guidance

Voltage dips, short interruptions and voltage variations on power supply input lines EN 61000-4-11

Power frequency (50/ 60 Hz) magnetic field

EN/IEC 61000-4-8

NOTE: U

is the a. c. mains voltage prior to application of the test level.

5% U

(>95% dip in

) for 0,5 cycle

40% UT (60% dip in U

cycles 70% U

(30% dip in

) for 25 cycles

) for 5 s

(>95% dip in

< 5% U U

) for 5

(>95% dip in

5% U

) for 0,5 cycle

40% UT (60% dip in U

cycles 70% U

(30% dip in

) for 25 cycles

< 5% U in U

(>95% dip

) for 5 s

) for 5

Mains power quality should be that of a typical commercial or hospital environment. If the user of the ultrasound unit requires continued operation during power mains interruptions, it is recommended that the ultrasound unit is powered from an uninterruptible power supply or a battery.

3 A/m 3 A/m Power frequency magnetic

fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

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Safety

Electromagnetic immunity (continued)

Table 2-3: Electromagnetic immunity (Part 2)

Guidance and manufacturer ’s declaration – electromagnetic immuni ty – for all medical

electrical equipment and medical electrical systems that not life-supporting

The Vscan Extend is intended for use in the electromagnetic environment below. The

customer or the user of the Vscan Extend should assure that it is used in such an

environment.

Immunity test

Conducted RF EN 61000-4-6

Radiated RF EN 61000-4-3

IEC 60601 test

level

3Vrms 150 kHz to 80 MHz

3 V/m 80 Mhz to 2,5 GHz

Complianc

e level

3 V/m

Electromagnetic

environment – guidance

Portable and mobile RF communications equipment should be used no closer to any part of the ultrasound unit, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

80 MHz to 800 MHz

800 MHz to 2.5 GHz

where p is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site

survey,

should be less than the compliance

level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

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Important safety considerations

Table 2-3: Electromagnetic immunity (Part 2) (Continued)

Guidance and manufacturer ’s declaration – electromagnetic immuni ty – for all medical

electrical equipment and medical electrical systems that not life-supporting

The Vscan Extend is intended for use in the electromagnetic environment below. The

customer or the user of the Vscan Extend should assure that it is used in such an

environment.

IEC 60601 test

Immunity test

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the ultrasound unit is used exceeds the applicable RF compliance level above, the ultrasound unit should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the ultrasound unit.

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

level

Complianc

e level

Electromagnetic

environment – guidance

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Safety

Separation distances

Table 2-4: Separation distances

Recommended separation distances between portable and mobile RF communications

equipment and the ultrasound unit

The ultrasound unit is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the ultrasound unit can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the ultrasound unit as recommended below, according to the maximum output power of the communications equipment.

Separation distance according to frequency of transmitter (m)

Rated maximum output of transmitter W

0,01 0,12 0,12 0,23 0,1 0,38 0,38 0,73 1 1,2 1,2 2,3 10 3,8 3,8 7,3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d

in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz

Essential Performance

The essential performance of the Vscan Extend is:

• The ability to display physiological images as input for diagnosis by qualified and trained healthcare professionals.

• The ability to display quantified data as input for diagnosis by qualified and trained healthcare professionals.

• The display of ultrasound indexes as aid for safe use of the Vscan Extend.

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Acoustic output

Definition of the acoustic output parameters

Thermal Index

TI is an estimate of the temperature increase of soft tissue or bone. There are three thermal index categories:

• TIS: Soft tissue thermal index. The main TI category. Used for applications that do not image bone.

• TIB: Bone thermal index (bone located in a focal region). Used for fetal application.

• TIC: Cranial bone thermal index (bone located close to the surface). Used for transcranial application.

Reference to calculation of TI can be found in:

• NEMA Standards Publication UD 3: “Standard for Real-T ime Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment”, Revision 2

• EN/IEC 60601-2-37. Medical electrical equipment. Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment

Important safety considerations

Mechanical Index

Ispta

MI is the estimated likelihood of tissue damage due to cavitation. The absolute maximum limits of the MI is 1.9 as set by the FDA guidance of September 9, 2008 for diagnostic ultrasound systems and transducers.

The Ispta is the Spatial Peak Temporal Average Intensity. The absolute maximum limit of Ispta is 720 mW/cm FDA guidance of September 9, 2008 for diagnostic ultrasound systems and transducers.

as set by the

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Safety

Acoustic output and display on Vscan Extend

MI and TI values are displayed on the scanning screen. The maximum possible MI and Ispta on the Vscan Extend is

within the limits set in Track 3 in the FDA guidance of September 9, 2008 for diagnostic ultrasound systems and transducers, MI <1.9 and Ispta <720 mW/cm

Display Accuracy and Acoustic Measurement Uncertainties

The display accuracy and measurement precision of the output display are summarized in the table below. Accuracy of the output display (TI, MI) parameters depends on the measurement system precision, the acoustic model used to calculate the parameters and variation in the acoustic output of probes and systems. The measurement precision and overall accuracy of the measurements have been as ses se d by determining both the random and the systematic uncertainties and given in percent at 95% confidence level.

Table 2-5: Display accuracy

Parameter Estimated accuracy

Pressure, MI ±25% ±15% Power, TI ±50% ±40%

a. Accuracy = (Measured value - displayed value)/displayed value * 100%

Measurement precision

black and white/color

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System controls affecting acoustic output

The operator controls that directly affect the acoustic output are discussed in the Acoustic Output Data Tables (See ‘Acoustic Output Reporting Tables’ on page 7-3 for more information.). These tables show the highest possible acoustic intensity for a given mode, obtainable only whe n the maxim um combination of control settings is selected. Most settings result in a much lower output. It is important to note the following:

• The duration of an ultrasound examination is as important as the acoustic output, since patient exposure to output is directly related to the exposure time.

• Controls can help to reduce patient exposure, even though it may not directly affect acoustic output.

The British Medical Ultrasound Society has suggested some maximum scanning times relative to displayed TI as follows:

Table 2-6: Maximum scanning times

General Abdominal, *Peripheral

Vascular, Adult cephalic,

Musculoskeletal, cardiac and other

Obstetric scanning

Important safety considerations

scanning

TI time TI time Note

0.0–0.7 Unlimited 0.0–1.0 Unlimited Monitor TI

0.7–1.0 < 60 min 1.0–1.5 < 120 min

1.0–1.5 < 30 min 1.5–2.0 < 60 min

1.5–2.0 < 15 min 2.0–2.5 < 15 min

2.0–2.5 < 4 min 2.5–3.0 < 4 min

2.5–3.0 < 1 min *Peripheral vascular is applicable for only dual probe

References

• The British Medical Ultrasound Society. Guidelines for the safe use of diagnostic ultrasound equipment.

• American Institute of Ultrasound in Medicine Consensus Report on Potential Bioeffects of Diagnostic Ultrasound.

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Safety

Application selection

Selecting the application appropriate to a particular ultrasound examination automatically provides acoustic output limits within FDA guidances for that application. Other parame te rs which optimize performance for the selected application are also set automatically, and should assist in reducing the patient exposure time.

Changing imaging modes

Acoustic output depends on the imaging mode selected. This greatly affects the energ y absorbed by the tissue (see ‘Acoustic Output Reporting Tables’ on page 7-3 for TI and MI values in black and white or color imaging).

ALARA

Ultrasound procedures should be performed using output levels and exposure times As Low Reasonably Achievable (ALARA) while acquiring clinical information.

During a diagnostic ultrasound examination, high frequency sound penetrates and interacts with tissue in and around the area of anatomy to be imaged. Only a small portion of the sound energy is reflected back to the probe for use in constructing the image while the remainder is dissipated within the tissue. The interaction of sound energy with tissue at sufficiently high levels can produce biological effects (aka bioeffects) of either a mechanical or thermal nature. Bioeffect is ge nerally undesired in diagnostic application and may be harmful in some conditions.

ALARA training is provided in the Medical Ultrasound Safety booklet, published by AIUM (American Institute of Ultrasound in Medicine) provided on the Documentation CD. 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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ALARA (continued)

Training

Important safety considerations

To contact the AIUM concerning their publications:

• In the USA, by telephone at 1-800-638-5352

• To write them, use the following address: AIUM

14750 Sweitzer Lane Suite 100 Laurel, MD, USA 20707-5906

In addition, the sections ‘Acoustic output and display on Vscan Extend’ on page 2-20 and ‘System controls affecting acoustic output’ on page 2-21 should be studied carefully in order to implement ALARA.

During each ultrasound examination the user is expected to weigh the medical benefit of the diagnostic information that would be obtained against the risk of potential harmful effects. Once a diagnostic image is achieved, prolonging the exposure cannot be justified. It is recommended that all users receive proper training in applications before performing them in a clinical setting.

Environmental protection

System disposal

The equipment must not be disposed of as unsorted municipal waste nor be destroyed by incineration.

It must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment.

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Safety

Maximum probe temperature

The table below indicates the maximum probe temperature.

Table 2-7: Maximum probe temperature

Probe

Vscan Extend – configured with Sector probe: Phased array transducer (G3S) for Deep scanning

Vscan Extend – configured with Dual probe: Phased array transducer (G3S) for Deep scanning

Vscan Extend – configured with Dual probe: Linear array transducer (G8L) allowing shallow scanning

NOTE: Measurement uncertainty and probe variation: 2 °C. NOTE: Lens temperature measured under following conditions per EN/

IEC 60601-2-37:

• Thermocouple was placed at the geometric center of the lens.

• Thermal phantom at 33 °C (or 23 °C) for external probes. (Temperature rise is measured and added to 33 °C if the phantom is at 23 °C).

NOTE: Thermal phantom made with tissue-mimicking material as

referenced in EN/IEC 60601-2-37.

• Probe placed upright in contact with above thermal phantom.

• Auto-freeze capability is disabled.

• Lens temperature is monitored for 30 minutes.

Max Temp in deg C

(Simulated use)

39.7 43.1

41 42.6

39.1 42.3

Max Temp in deg C

(Still air)

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Device labels and symbols

Vscan Extend Labels (Example)

Device labels and symbols

Figure 2-2. Vscan Extend rating label

1. Rating label

2. Inner label

3. UDI label - contains UDI information

4. Serial number label - contains device serial number

NOTE: The label shown in Figure 2-2 is a sample. The label varies

country to country based on country requirements.

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Safety

Vscan Extend Labels (Example) (continued)

Figure 2-3. Vscan Extend battery label

Figure 2-4. Vscan Extend AC/DC adapter label

Figure 2-5. Vscan Extend external battery charger label

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Vscan Extend Labels (Example) (continued)

The following table describes the purpose of safety labels and other important information provided on the equipment.

Table 2-8: Label Icons

Label Purpose Location

CE mark • Vscan Extend system

Device labels and symbols

• Vscan Extend External Battery charger

This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Please contact the manufacturer or other authorized disposal company to decommission your equipment.

Follow instructions for use. Read and understand all instructions in the User's Manual before attempting to use the ultrasound unit.

TÜV mark Vscan Extend system

Prescription device statement for the USA only: Caution: Federal law restricts this device to sale by or on the order of a physician.

Type BF Applied Part symbol (see ‘Classifications’ on page i-5)

Keep dry Vscan Extend system

• Vscan Extend system

• Vscan Extend battery

• Vscan Extend External battery charger

• Vscan Extend system

• Vscan Extend External Battery charger

Vscan Extend system

Input, use only Vscan Extend charger. Vscan Extend system

Vscan Extend External Battery charger

Rechargeable, use only Vscan Extend battery.

Input to Vscan Extend battery Vscan Extend External Battery

Vscan Extend system Vscan Extend External Battery charger

charger

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Safety

Table 2-8: Label Icons (Continued)

Label Purpose Location

Assembled in Romania (Romania is a country name)

Manufacturer name and address • Vscan Extend system

Manufacturing date (year-month) • Vscan Extend system

Part number • Vscan Extend system

Serial number • Vscan Extend system

Unique Device Identification (UDI). Every system has a unique marking for identification. Scan or enter the UDI information into the patient health record according to governing laws.

Refer label inside Vscan Extend system

Identify the customs country of origin of the materials.

• Vscan Extend External Battery charger

Vscan Extend system

Push button (power switch) Vscan Extend system

NOTE: As a safety precaution, scanning is not possible when charging

the battery.

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Device labels and symbols

Explanation of the Pollution control label for China

The following product pollution control information is provided according to SJ/T11364-2014 Marking for Restriction of Hazardous Substances caused by electrical and electronic products

Table 2-9: Label for China

Label Description

This symbol indicates the product contains hazardous materials in excess of the limits established by the Chinese standard GB/T 26572 Requirements of concentration limits for certain restricted substances in electrical and electronic products. The number in the symbol is the Environment-friendly Use Period (EFUP), which indicates the period during which the hazardous substances contained in electrical and electronic products will not leak or mutate under normal operating conditions so that the use of such electrical and electronic products will not result in any severe environmental pollution, any bodily injury or damage to any assets. The unit of the period is “Year”. In order to maintain the declared EFUP, the product shall be operated normally according to the instructions and environmental conditions as defined in the product manual, and periodic maintenance schedules specified in Product Maintenance Procedures shall be followed strictly. Consumables or certain parts may have their own label with an EFUP value less than the product. Periodic replacement of those consumables or parts to maintain the declared EFUP shall be done in accordance with the Product Maintenance Procedures. This product must not be disposed of as unsorted municipal waste, and must be collected separately and handled properly after decommissioning.

Table 2-10: Hazardous substances

Hazardous Substances' Name

Component Name

Probe & Cable X OOOOO Main unit OOOOOO O: Indicates that hazardous substance contained in all of the homogeneous materials for this part is below

the limit requirement in GB/T 26572. X: Indicates that hazardous substance contained in at least one of the homogeneous materials used for this part is above the limit requirement in GB/T 26572.

• Data listed in the table represents best information available at the time of publication.

• Applications of hazardous substances in this medical device are required to achieve its intended clinical uses, and/or to provide better protection to human beings and/or to environment, due to lack of reasonably (economically or technically) available substitutes.

Pb Hg Cd Cr

PBB PBDE

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Chapter 3

Preparing Vscan Extend for

Use

Contents: ‘Package contents’ on page 3-2 ‘System description’ on page 3-4 ‘Battery’ on page 3-15 ‘First time use’ on page 3-22 ‘Activation’ on page 3-24

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Preparing Vscan Extend for Use

Vscan Extend package contents

Make sure all items listed below are included in the package.

Package contents

Figure 3-1. Vscan Extend package contents

1. Vscan Extend softcase with device and probe

2. USB cable

3. Gel bottle location

4. Region-specific plugs

5. AC/DC adapter

6. Battery

Table 3-1: Package content

Item Description

Vscan Extend Quick Card

Vscan Extend User Manual

Service contact information

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Environmental requirements

Environmental requirements for the device

Table 3-2: Environmental requirements

Description Operational Non operational Storage and transport

Temperature 0 °C to + 40 °C - 40 °C to + 70 °C - 40 °C to + 70 °C Humidity 90%, non-condensing 15–90% 90%, non-condensing Air pressure 620 hPa to 1060 hPa 620 hPa to 1060 hPa 620 hPa to 1060 hPa

Transient operating conditions

NOTE: Permissible transient environmental operating conditions:

• Temperature range of 0-40 degrees

• Relative humidity range of 15 to 90% non-condensing

NOTE: Avoid exposing the unit to saline moisture. In case of exp osu r e

to saline moisture, clean the unit as described on ‘Cleaning and disinfection’ on page 6-4.

Refer to Table 3-2 above for additional information regarding storage of the battery.

Image display on the Vscan Extend is dependent on ambient light; avoid direct sunlight or reflections from other light sources on the display when scanning and reviewing images. The display viewing angle should be as small as possible.

If you are having difficulty seeing the image due to the lighting conditions try to change brightness (see ‘Scan Settings’ on page 4-2) or change your position/location of use.

The time required for the Vscan Extend to warm from minimum storage between uses until the device is rea dy fo r use at 20 degrees ambient is approximately 1 minute.

The time required for the Vscan Extend to cool from minimum storage between uses until the device is rea dy fo r use at 20 degrees ambient is approximately 1 minute.

The Vscan Extend is transportable in a road a mbulance or fixe d /rotary wing aircraft.

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System description

System overview

Vscan Extend configured with a Sector probe for deep scanning

Figure 3-2. Vscan Extend with a Sector probe

1. Display

2. Sector probe

3. Serial port (For Service ONLY)

NOTE: Green LED indicates Vscan Extend is fully charged and an

amber LED indicates it is charging.

4. Power button

5. LED indicates charging status

6. USB port and Power connector

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System description

Vscan Extend configured with a Dual probe holding both a phased array and linear array transducer for deep and shallow scanning

Figure 3-3. Vscan Extend with Dual probe

1. Display

2. Dual probe

3. Serial port (For Service ONLY)

NOTE: Green LED indicates Vscan Extend is fully charged and an

amber LED indicates it is charging.

4. Power button

5. LED indicates charging status

6. USB port and Power connector

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Vscan Extend Dual Probe

Figure 3-4. The dual prob e

1. Phased array transducer (deep scanning)

2. Linear array transducer (shallow scanning)

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Accessories and Configurations

Standard and optional accessories

Table 3-3: Standard accessories

Accessory Figure

1. Global AC adapter with interchangeable region-specific plugs

2. One rechargeable battery

3. USB cable

4. MicroSD memory card (For service personnel only. Not for customer use.*)

System description

5. Soft case

6. User Manual

7. Hardcopy Quick Card

* The microSD card provided in the device captures error logs and is strictly for Service personnel only. The user must remove this microSD card and insert a blank one when performing data backup. The microSD card that captures error log files is used for troubleshooting by the Repair Depot.

** Not available in all countries

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Preparing Vscan Extend for Use

Accessory Figure

8. Gel (60g bottle)

** Not available in all countries

Table 3-3: Standard accessories

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Standard and optional accessories (continued)

Table 3-4: Optional accessories

Accessory Figure

1. Additional Soft case

2. Robust case to carry complete Vscan Extend set

3. Robust case to carry only scanner, gel, and potential extra battery

4. External Battery charger

System description

5. Additional Battery

6. Additional AC adapter

7. Hardcopy User manual

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Connectivity Configurations

Vscan Extend is available in three different connectivity configurations:

1. USB configuration

2. Wi-Fi Access configuration

3. DICOM configuration The table below describes the standard and connectivity

configurations.

Table 3-5: Configurations

USB

Description

Generic image format (jpg, mp4) for data stored on device or exported to PC

Image transfer to PC via USB cable A A A Manual labeling of exam data with

patient ID FIPS compliant data encryption A A A Data backup capability on microSD card A A A Wireless image transfer to shared

network folders Enterprise grade wireless encryption

standards including EAP and WPA2 (PSK)

Mobile Device Management client support

Access to GE marketplace to selectively download and install Vscan Extend apps Bladder Volume A A Lung Protocol A A Tricefy Uplink A A Wireless reading DICOM Modality

Worklist Wireless image export in DICOM format A Access to reference materials on Vscan

web portal

configuration

AAA

Wi-Fi Access

configuration

DICOM

configuration

* The Vscan Extend app represents only the interface to the cloud-ba sed case exchange solution which is separately provided by GE

A: Available Blank cells indicates: Not Available

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External battery charger compartment (option)

The external battery charger compartment is used to charge the battery outside the Vscan Extend.

NOTE: The Vscan Extend battery can either be charged in the main un it

by directly plugging the AC/DC adapter or externally by placing the Vscan Extend battery on the external battery charger.

NOTE: Scanning is disabled during charging if charged in the main unit.

Figure 3-5. External battery charger compartment

The table below lists the units or parts that can be replaced by the user (CRU - Customer Replacable units)

System description

Table 3-6: CRU

Description Part number

Battery 5693456 AC/DC adapter 5693487 Application Software SD

Card External Battery Charger 5716861

5716858

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Display screens

Figure 3-6. Scanning screens (Black and white mode)

Phased array transducer

1. Header

• Menu icon

• Patient information

• Exam number

• Battery level indicator

• MI and TI values

2. Depth scale

3. Footer

• Color icon

• Gain

• Depth

• Store

Linear array transducer

1. Header

• Menu icon

• Patient information

• Exam number

• Battery level indicator

• MI and TI values

2. Depth scale

3. Footer

• Color icon

• Gain

• Depth

• Store

NOTE: The screen graphics in this manual are only for illustrational

purposes. Actual screen output or graphics may vary.

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Display screens (continued)

System description

Figure 3-7. Scanning screens (Color mode)

Phased array transducer

1. Header

• Menu icon

• Patient information

• Exam number

• Battery level indicator

• MI and TI values

2. Depth scale

3. Footer

• Color icon

• Gain

• Depth

• Store

4. Color bar

5. Color ROI (Region of Interest)

Linear array transducer

1. Header

• Menu icon

• Patient information

• Exam number

• Battery level indicator

• MI and TI values

2. Depth scale

3. Footer

• Color icon

• Gain

• Depth

• Store

4. Color bar

5. Color ROI (Region of Interest)

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Display screens (continued)

Figure 3-8. Menu screen

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Battery

Vscan Extend Battery

The Vscan Extend system is powered by a Li ION battery (Model - U80395). The battery is not fully charged prior to shipment. To maximize time of use, it is recommended to recharge the battery before use for at least 1.5 hours. Establish a routine for charging the battery to maximize system availability.

The battery must be charged while housed in the Vscan Extend or in the external battery charger.

The Li ION battery, used in Vscan Extend, with the battery code is displayed below.

Figure 3-9. Vscan Extend battery

Battery specification

Table 3-7: Battery specification

Items Unit Value Description

Basic Voltage mV 7400 MAX

Current mA 1150 Avg 1C

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Battery (continued)

WARNING

CAUTION

Use only the AC adapter provided with the Vscan Extend. The Vscan Extend cannot be charged via the USB cable when

connected to a PC.

Figure 3-10. Vscan Extend AC adapter

The AC adapter must be kept outside the patient environment (refer to local regulation and EN 60601-1).

Figure 3-11. Patient environment

1. Patient environment

WARNING

Do NOT simultaneously touch the patie nt and the char ger plu g on the AC adapter.

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Power plugs

Vscan Extend Battery

1. Select the country specific plug.

Figure 3-12. Power plugs

Voltage requirement s

1. North America, Japan

2. China

3. Australia, New Zealand

4. UK, Hong Kong, Singapore

5. Continental Europe and Korea (for unearthed electrical outlet)

2. Insert the relevant plug into the adapter.

Figure 3-13. Insert the plug

The AC/DC adapter will function on voltage from 100 to 240 VAC and 50/60 Hz.

CAUTION

Only use mains power of 100 – 240 VAC. Voltage outside this range can cause a malfunction or destroy the AC/DC adapter.

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Charging the battery

1. Insert the battery into the device.

Figure 3-14. Insert the ba tte ry

2. Plug the AC/DC adapter into the electrical outlet.

Charging the battery using the optional External battery charger compartment

1. Place the external battery charger on a flat surf ac e.

2. Insert the battery in the compartment.

NOTE: Do not apply excessive pressure to the battery while

inserting it into the compartment. There is no snap p ro vided on the external battery charger. The battery fits smoothly into the compartment without a click.

3. Plug the charger plug into the charger connector on the external battery charging compartment.

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Battery level indicator

The battery level indicator is displayed on the screen. The following icons are displayed.

Vscan Extend Battery

Table 3-8: Battery level indicator

Icon Description

Battery fully charged (>=95%).

Battery 75% charged (>=70% and <95%).

Battery 50% charged (>=45% and <70%).

Battery critical, or low Battery (<45%). Prepare to recharge the battery or have a spare battery available.

Battery charging.

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Preparing Vscan Extend for Use

Inserting/removing the battery

To insert the battery

1. Insert the battery in the compartment until the lid clicks in place.

To remove the battery

1. Power off the Vscan Extend.

Figure 3-15. Inserting ba tt er y

CAUTION

Do not attempt to remove the battery without powering off the Vscan Extend.

2. Push the button on the battery compartment lid and lift the battery.

Figure 3-16. Removing battery

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Battery specifications

Table 3-9: Battery specification

Item Specification

Charging time at 90% About 75 minutes Capacity About 1 hour while continuously scanning Lifetime At least 300 charges

In order to get maximum charging capacity with your Vscan Extend battery, you should initially allow the battery to be fully charged and then fully discharged at least three times. Perform normal operation during these cycles. Once the initial charging/ discharging cycles are performed, the following is applicable without reducing the lifetime of the battery:

• It is not necessary to completely discharge the battery before re-charging.

• It is possible to stop charging the battery before it is fully charged, but the battery will then be discharged more rapidly.

• It is possible to charge the battery several times each day, if needed.

Vscan Extend Battery

When storing the Vscan Extend for a period longer than three months, remove the battery from the Vscan Extend main unit. Recharge the battery every three months to maintain battery performance. When the battery is stored separately, storage can be at least one year before recharging the battery is needed.

NOTE: Make sure to remove the battery from the device before

shipping from one place to another.

To minimize battery performance degradation, avoid prolonged storage of the battery outside the Vscan Extend operational temperature range (see ‘Environmental requir ements for the device’ on page 3-3).

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First time use

Before Vscan Extend can be used, the following steps must be done:

1. Install the battery. (See ‘To insert the battery’ on page 3-20 for more information.)

2. Press the Power button to power on Vscan Extend.

3. Activate Vscan Extend. (See ‘Vscan Extend activation’ on page 3-24 for more information.)

Power on/off

Initial use

To power on the Vscan Extend

Press the Power button. Device boots up and scan screen displays within 45 seconds.

NOTE: The Scan screen displays only when the device has been

activated. See ‘Activation’ on page 3-24 for more information.

To power off the Vscan Extend

1. Press the Power button. A pop-up displays prompting to Power off OR Restart.

2. Select Power off.

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To restart Vscan Extend

1. Press and hold the Power button.

2. Select Restart to restart the device.

Standby Mode

Vscan Extend enters standby mode when the Power bu tton is quickly pushed. In this mode, Vscan Extend will not have power to the probe or any display.

OR Vscan Extend enters standby mode automatically while in

freeze mode for more than 10 minutes. Push the Power button again once to resume from standby

mode. The device is ready to scan within a second.

NOTE: When resuming the device from standby mode, a new exam is

created and the previous exam data is lost, if not previously saved.

Initial use

Sleep Mode

NOTE: When resuming the device from sleep mode, a new exam is

Startup procedure

Vscan Extend enters sleep mode if it continues to be in standby mode for more than 3 hours.

Push the Power button again to resume from sleep mode. The device is ready to scan within approximately 5 seconds.

created and the previous exam data is lost, if not previously saved.

The approximate time taken for the device from switching on until the device is ready for normal use is 40 seconds.

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Vscan Extend activation

Activation

There are three possible scenarios to activate Vscan Extend:

1. Scenario 1: Activation using Wi-Fi on the Vscan Extend device.

2. Scenario 2: Manual activation - activate Vscan Extend by visiting the url: https://vscanactive.gehealthcare.com from a PC.

3. Scenario 3: Activation without internet access. If there is no internet access, contact GE Service (see page 1-8 for phone numbers, then see ‘Offline activation’ on p age 4-12) to activate Vscan Extend.

Activation using Wi-Fi

The activation process includes steps to register the Vscan Extend device.

NOTE: When Wi-Fi is enabled the device can be activated directly.

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Set Language, Date and Time

1. Connect Vscan Extend to a power source.

2. Press the Power button to power on Vscan Extend. The Startup screen displays, followed by the Language

screen.

NOTE: The default language is set to English.

3. To choose another language, press Change Language.

Initial use

Figure 3-17. Select language

4. Choose the desired language. The screen changes back to the Language screen.

5. Press Next.

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Preparing Vscan Extend for Use

Set Language, Date and Time (continued)

6. The Date and Time screen displays.

NOTE: The current date and time is set by default.

7. Press Change Date and Time to change the date and time, if needed.

Figure 3-18. Date and Time

Choose either the automatic date and time format which sets the date and time by synchronizing through the internet.

OR Set the date and time manually.

8. Press Next.

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Connecting Wi-Fi

NOTE: If Wi-Fi is not detected, configure Wi-Fi. See ‘Configuring Wi-Fi’

Initial use

on page 4-23 for more information.

1. Select your Wi-Fi network and enter your Wi-Fi password. (All non hidden Wi-Fi networks are displayed.)

Figure 3-19. Wi-Fi settings

2. Press Next.

NOTE: Ensure that the Vscan Extend is connected to a non-clinical

Wi-Fi hotspot to start activation.

NOTE: A non-clinical Wi-Fi has access to the public internet, which is

not part of the hospital internet. If you are unable to view the non-clinical Wi-Fi or do not have the password, contact your system administrator.

NOTE: If you do not have access to public Wi-Fi, proceed with manual

activation of the device. See ‘Manual activation’ on page 3-35 for more information.

NOTE: If the hospital network does not have an internet connection,

proceed with manual activation of the device. See ‘Manual activation’ on page 3-35 for more information.

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Preparing Vscan Extend for Use

Connecting Wi-Fi (continued)

1. Enter the authentication details to connect to the network.

Figure 3-20. Authentication code

2. Once the device connects to the network, press the Back arrow to exit the Settings screen.

The screen changes back to the Wi-Fi screen (Figure 3-19 on page 3-27.)

3. Press Next.

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Registration

First time registrants

Initial use

Registering the device creates a Vscan Extend account which enables access to the GE Marketplace and other features.

1. First time registrants, press Register to create an account. Enter the required details.

Figure 3-21. Registration details

NOTE: If you have previously registered a Vscan Extend device,

press Already Registered using your registered email. See ‘Registered users’ on page 3-31 for more information.

HINTS

Press the Arrow key twice to get the letters in all caps and press the number key to toggle between numbers and alphabet.

Figure 3-22. Keyboard tips

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Preparing Vscan Extend for Use

First time registrants (continued)

2. Check the desired options to either participate in collaborative GE activities or to receive special offers and promotions.

Press Register.

3. An email is sent to the email address used during registration.

NOTE: The email has a link requiring you to change your password

for security purposes.

4. Press Activate my device.

Figure 3-23. Choose an option

5. Vscan Extend has been activated. Press Start Using Device.

Figure 3-24. Start using Vscan Extend

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Registered users

NOTE: Ensure Vscan Extend is connected to a non-clinical Wi-Fi.

Initial use

1. Press Already Registered.

2. Enter your email ID and password.

Figure 3-25. Already Register ed

NOTE: If you log in with a wrong email ID, a pop-up message

displays: “Login error: Your email ID is not confirmed yet”. Try again with a valid email ID.

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Preparing Vscan Extend for Use

Registered users (continued)

3. While the activation process is in progress, the wireless is connecting to the GE Store and the activation key is being entered automatically.

4. Press Activate my device.

5. Vscan Extend has been activated. Start using the device.

Figure 3-26. Start using Vscan Extend

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Already registered users - Forgot password

1. If you forgot your password, press Forgot Password.

2. An email is sent to your confirmed email address with a link to reset the password.

Figure 3-27. Forgot password

3. Click on the link on a personal computer to reset the password.

4. Enter your email ID and new password. The Vscan Extend is activated and ready to use.

Initial use

Figure 3-28. Reset password and start using Vscan Extend

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Preparing Vscan Extend for Use

Network access failed

1. If you are unable to connect to a Wi-Fi network, press Retry and try to activate the device again.

2. If the problem persists, contact your internet service provider and GE at help@gehc.com to connect to the network.

3. If the network is not accessible or you are unable to connect to the network, you can activate Vscan Extend manually. See ‘Manual activation’ on page 3-35 for more information.

Figure 3-29. Retry

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Manual activation

NOTE: The PC should have internet access. If there is no internet

Initial use

To activate Vscan Extend without Wi-Fi connection, follow the steps below.

1. Open the URL (https://vscanactive.gehealthcare.com) in the internet browser on your PC.

access, call GE Service center or contact your local Sales representative.

2. Follow the directions provided on the site to generate the activation key for Vscan Extend.

The following information is required:

• The Vscan Extend serial number written on the rea r

label of the system.

3. User information as per the figure below.

Figure 3-30. User Information

4. Enter other necessary details.

Figure 3-31. Opt-in checkbox

Figure 3-32. Opt-in comm u nic at ion

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Preparing Vscan Extend for Use

Manual activation (continued)

5. Press Submit to initiate registration.

6. The Activation key is generated. Store the key in a convenient location to enter into the device and for future reference.

Figure 3-33. Submit

Figure 3-34. Activation key details

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Activation key

Initial use

The Activation key screen is displayed on the Vscan Extend.

1. Enter the activation key generated while registering on the portal (https://vscanactive.gehealthcare.com)

Figure 3-35. Enter activation key

HINTS

Press the Backspace key if a mistake occurred while entering the activation key.

2. Press Activate.

Figure 3-36. Start using the device

3. Vscan Extend has been activated. Start using the device.

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Chapter 4

Vscan Extend Settings

Contents: ‘Settings’ on page 4-2 ‘Scan Settings’ on page 4 - 2 ‘Server Settings’ on page 4-3 ‘Diagnostics’ on page 4-12 ‘Wi-Fi’ on page 4-21 ‘MDM Installation Procedures (Optional)’ on page 4-24 ‘Certificate Authority’ on page 4-28 ‘GE Marketplace’ on page 4-31

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Vscan Extend Settings

The following settings and functions are available under the main Settings menu.

Scan Settings

Press Menu -> Settings

Settings

Figure 4-1. Settings

• Brightness - adjusts the screen brightness of the device Swipe the brightness level indicator to the left to decrease

the brightness and swipe to the right to increase the brightness.

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Scan Settings (continued)

Auto Freeze (Probe) - set the auto freeze time.

1. Press Auto Freeze (Probe)

2. Choose the desired value

3. Press OK to set the value

Video Duration - set duration of the captured Cine loops.

1. Press Video Duration

2. Choose the desired value

3. Press OK to set the value

Unit of Measurement - set unit of measurement

1. Press Unit of Measurement

2. Choose the desired unit

3. Press OK to set the value

Set current preset as default

1. Press Set Current Preset as Default

2. Press Yes to set the displayed preset as default.

Settings

Server Settings

Allows to configure the DICOM servers.

Figure 4-2. Server settings

Worklist Server - gets patient and intended study information Image Server - remote store location for media (video/images) DICOM Encoding - Choose the desired encoding type and press

OK.

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Vscan Extend Settings

Server Settings (continued)

To configure the Worklist server:

HINTS

Press the title bar (the entire top section on the screen) or swipe left most side of the screen to access the Menu.

1. Press Menu -> Settings

Figure 4-3. Settings

2. Scroll down to Server Settings. Press Worklist Server.

Figure 4-4. Worklist server

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Configure Worklist Server

Connect Vscan Extend to the hospital wireless network. See ‘Activation using Wi-Fi’ on page 3-24 for more information.

1. Enter all fields to add a new Worklist server.

Settings

Figure 4-5. Configure Worklist Server

NOTE: Swipe upwards to get the full screen and enter all details.

Contact the hospital IT administrator for details.

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Vscan Extend Settings

Configure Worklist Server (continued)

NOTE: By default, DICOM is listed while configuring the Worklist

Server.

Figure 4-6. DICOM listed

2. Enter any unique name for Calling AE Title (e.g. Nixon Building Schedule).

3. Press Add Server to add the Worklist Server.

4. Press Verify to verify communication with the Worklist Server.

Figure 4-7. Verify Worklist Server

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GE Healthcare VSCANEXTEND User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Vscan Extend™

Table of Contents

Introduction

Overview

Warnings

Contact Information

Safety

Introduction

Owner responsibility

Important safety considerations

Maximum probe temperature

Device labels and symbols

Package contents

Environmental requirements

System description

Vscan Extend Battery

Initial use

Vscan Extend Settings

Settings