Vscan User Manual Ver 1.x Rev 04

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. It applies to all versions of the 1.x.x software for the Vscan ultrasound system. This manual is a reference for the Vscan gateway software. It applies to all versions of the 1.x.x Vscan gateway software.

GE Healthcare

Manual status: GM092102-04 30 August 2010 Manufacturer: GE VINGMED ULTRASOUND A/S Strandpromenaden 45 N-3191 Horten, Norway Tel.: (+47) 3302 1100 Fax: (+47) 3302 1350

Regulatory Requirements

Conformance Standards The GE Healthcare 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 Vingmed Ultrasound. Ignoring this advice may compromise the regulatory approvals obtained for the product. This product complies with the regulatory requirement of the following: Standard/Directive

Scope

93/42/EEC

Medical Devices Directive (MDD)

EN55011

Emitted noise according to Class B requirements

IEC60601-1 EN60601-1 UL60601-1 CAN/CSA-C22.2 No 601.1-M90

Medical Electrical Equipment, Part 1; General Requirements for Safety

IEC60601-2-37

Medical electrical equipment - Part 2-37. Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment

IEC1157 / EN61157

Requirements for the declaration of the acoustic output of medical diagnostic ultrasonic equipment.

IEC60601-1-2 EN60601-1-2

Medical Electrical Equipment - part 1-2. Collateral standard: Electromagnetic compatibility - Requirements and tests.

IEC60601-1-4 EN60601-1-4

Medical Electrical Equipment - part 1-4. Collateral standard: Programmable electrical medical systems

IEC60601-1-6

Medical Electrical Equipment - part 1-6. Collateral standard: Usability.

NEMA/AIUM UD-3

Standard for real-time display of thermal and mechanical acoustic output indices on diagnostic ultrasound equipment.

ISO10993-1

Biological evaluation of medical devices

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Country Specific Approvals •

JAPAN MHLW Approved Number: 221ABBZX00252000

•

CHINA SFDA: Product Standard Number:

•

KOREA KFDA:

Certifications •

GE Vingmed Ultrasound is ISO 9001 and ISO 13485 certified.

Classifications The following classifications are in accordance with the IEC/ EN 60601-1. Type and degree of protection against electric shock: •

Vscan is internally powered battery operated during hand held scanning.

•

The AC adapter is Class II.

•

Vscan has type BF Applied Part.

•

Degree of protection against harmful ingress of water: Vscan parts and accessories except probe tip: ordinary equipment (IPx0) Probe tip: IPX1

Class II Equipment 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.

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Vscan – User Manual GM092102 04

Type BF Applied part TYPE BF APPLIED PART providing a specified degree of protection against electric shock, with particular regard to allowable LEAKAGE CURRENT. Normal mode Patient leakage current

<100 microA

Single fault condition <500 microA

Environmental requirements for the unit Requirement

Temperature

Humidity non-condensing

Air Pressure

Operational

10–40 °C

30–80%

700–1060 hPa

Non operational

-20–70 °C

30–90%

700–1060 hPa

NOTE:

Avoid exposing the unit to saline moisture. In case of exposure to saline moisture, clean the unit as described on page 6-4.

Original Documentation •

Vscan – User Manual GM092102 04

The original document was written in English.

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Vscan – User Manual GM092102 04

Table of Contents

Conformance Standards - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-1 Country Specific Approvals - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-2 Certifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-2 Classifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-2 Class II Equipment - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-2 Type BF Applied part - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-3 Environmental requirements for the unit - - - - - - - - - - - - - - - - - - - - - - - - i-3 Original Documentation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-3

Table of Contents Chapter 1 - Introduction General description Principles of operation- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-2 Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-2 Indication for use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3 Contraindication - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3

Warnings Conventions used in this manual Contact Information Contacting GE Healthcare Ultrasound - - - - - - - - - - - - - - - - - - - - - - - - 1-7 Global ultrasound support center phone numbers - - - - - - - - - - - - - - - - 1-8 Manufacturer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-11

Chapter 2 - Preparing the Vscan for use Package contents System description System overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-5

Battery Power plug adapter- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-12 Charging the battery using the Docking station - - - - - - - - - - - - - - - - - 2-12 Charging the battery using the External battery charging compartment 2-13 Battery level indicator - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-14 Removing / inserting the battery (GM-BAT) - - - - - - - - - - - - - - - - - - - - 2-15 Battery (GM-BAT) specifications - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-16

The microSD card Removing / inserting the microSD card - - - - - - - - - - - - - - - - - - - - - - - 2-17 The microSD card memory indicator- - - - - - - - - - - - - - - - - - - - - - - - - 2-19 The microSD card handling recommendations- - - - - - - - - - - - - - - - - - 2-20

First time use Installing the battery - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-21

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Vscan activation Vscan activation procedure - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-22

Chapter 3 - Using Vscan Switching on/off To switch on the Vscan - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-2 To switch off the Vscan - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-2

Scanning General scanning recommendations- - - - - - - - - - - - - - - - - - - - - - - - - - 3-3 Probe orientation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-5 Patient examination - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-5 Presets - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-6 Black and white imaging - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-6 Color imaging - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-7 Auto freeze - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-8 AutoCycle - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-8

Measurements Taking measurements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-9

Voice notations Recording Voice notations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-10

Review and storage Reviewing acquired images - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-11 Storage of images- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-11

Recall of stored data Deletion of data To delete an examination - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-14 To delete a file - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-14

Chapter 4 - Vscan gateway software Overview About the files created in Vscan - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-2

Vscan gateway software installation Computer requirements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-4 Installation and activation of Vscan gateway software - - - - - - - - - - - - - 4-5

Connection of Vscan to a computer Using Vscan gateway software Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-14 Gallery screen - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-15 Setup screen - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-20

Chapter 5 - Vscan configuration Config menu System setup adjustment - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-3

Chapter 6 - Vscan maintenance System care and maintenance Inspection Inspecting the Vscan- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-3 Inspecting the probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-3

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Cleaning and disinfection Cleaning - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-4 Disinfection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-5

Reinstallation of the factory software Procedure - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-7

Troubleshooting Vscan troubleshooting- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-9 Vscan gateway software troubleshooting - - - - - - - - - - - - - - - - - - - - - 6-10

Chapter 7 - Safety Introduction Owner responsibility Notice against user modification- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-3

Important safety considerations Patient safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-5 Personnel and equipment safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-7 Electromagnetic Compatibility (EMC) - - - - - - - - - - - - - - - - - - - - - - - - - 7-9 Acoustic output- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-16 Environmental protection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-18

Probe overview Maximum probe temperature Device labels and symbols

Chapter 8 - Appendix Acoustic Output Reporting Tables Definitions, symbols and abbreviations - - - - - - - - - - - - - - - - - - - - - - - - 8-2 Acoustic Output Reporting Tables for Track 3/IEC 60601-2-37 - - - - - - - 8-5

Measurement accuracy Distance measurement - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-7 Area measurement - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-7

Medical Ultrasound Safety Medical Ultrasound Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-9

Index

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Chapter 1 Introduction Contents: ‘General description’ on page 1-2 ‘Warnings’ on page 1-4 ‘Conventions used in this manual’ on page 1-6 ‘Contact Information’ on page 1-7

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Introduction

General description

Vscan is a battery operated pocket-sized general purpose ultrasound imaging system.

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. Sophisticated design with computer control offers a system with extensive features and functions which is user-friendly and easy to use.

Safety 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. All information in Chapter ‘Safety’ on page 7-1 should be read and understood before operating the ultrasound unit.

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General description Indication for use The Vscan ultrasound unit is intended for the following applications: •

Cardiac adult and pediatric

•

Abdominal

•

Pediatric

•

Urology

•

Fetal

•

Peripheral vascular

•

Thoracic/Pleural motion and fluid detection

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

CAUTION

For USA only: United States law restricts this device to sale or use by, or on the order of a physician.

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Introduction

Warnings

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

WARNING

1-4

•

Vscan is a precision instrument. Handle Vscan and its accessories with care. Do not subject Vscan 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 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.

•

If any liquid from 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 immerse or expose the battery to water.

•

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.

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Warnings WARNING

Vscan – User Manual GM092102 04

•

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.

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Introduction

Conventions used in this manual

Buttons and other controls on the Control panel or on the monitor screen are indicated by bold type. Program windows, screens and Dialogue boxes are indicated by italic type. The following icons, highlight safety issues as follow:

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DANGER

Indicates that a specific hazard exists that, given inappropriate conditions or actions, will cause severe or fatal personal injury with or without substantial property damage.

WARNING

Indicates that a specific hazard exists that, given inappropriate conditions or actions, can cause severe or fatal personal injury with or without substantial property damage.

CAUTION

Indicates that a potential hazard may exist that, given inappropriate conditions or actions, can cause minor injury or property damage.

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Contact Information

Contact Information

Contacting GE Healthcare 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 GE Healthcare

TEL: (1) 800-437-1171

Ultrasound Service Engineering

FAX: (1) 414-721-3865

9900 Innovation Drive Wauwatosa, WI 53226

Clinical Questions Please contact your local Applications or Sales Representative.

Service Questions For service in the United States, call GE CARES TEL: (1) 800-437-1171 NOTE:

When contacting GE CARES you will have to provide your system ID. If system ID is unknown, please give the Temporary System ID “VSCAN” to be properly routed for support. In other locations, contact your local Service Representative.

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Introduction Accessories Catalog Requests To request the latest GE Accessories catalog or equipment brochures in the United States, 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.

Americas Region

Telephone

Location

United States1

800-437-1171

Milwaukee

Canada

800-668-0732

Moncton

Mexico

0800 9043400

Sao Paulo

Puerto Rico

0800 4371171

Sao Paulo

Brazil

0800 122345

Sao Paulo

Argentina

0800 3331984

Sao Paulo

Chile

0800 367000

Sao Paulo

All other Latin American countries

55-11-5525-3537

Sao Paulo

1

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” to be properly routed for support.

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Contact Information Europe, Middle East and Africa Region

Telephone

Location

Algeria

+21321484612

Andorra

902 400 246

Austria

0800244260

Belarus

+37 517200009

Belgium Dutch

+32 262 638 38

Diegem

Belgium French

+32 262 638 39

Diegem

Bulgarian

+35929712040

Sofia

CIS

+7 495 739 69 68

Moscow

Denmark

80404944

Stockholm

Egypt

+202 19434 [hot line]

Cairo

Finland

0981710182

Stockholm

France

0800139140

Velizy

G. D. Luxembourg

080022973

Diegem

Germany

08004373784

Solingen

Greece

302109690660

Athens

Holy See

800 827168

Milan

Hungary

+36-23-410-510

Budapest

Ireland

1800992557

Dublin

Israel

Contact local distributor

Tel Aviv

Italy Central

800 827168

Milan

Italy North-East

800 827166

Milan

Italy North-West

800 827164

Milan

Italy South

800 827170

Milan

Liechtenstein

0041 44 809 9293

Monaco

0800139140

Netherlands

8000994442

Diegem

Northern Ireland

08000720248

Belfast

Norway

80062043

Stockholm

Portugal

800 834 004

Madrid

Russia

+7 495 739 69 75

Moscow

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Vienna

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Introduction Region

Telephone

Location

San Marino

800 827168

Milan

Saudi Arabia

800 1243002

Saudi Arabia

South Africa

800 111 671

South Africa

Spain

902 400 246

Madrid

Sweden

0201201436

Stockholm

Switzerland

0800556958

Zurich

Turkey

Contact local distributor

Istanbul

UAE

800 3646

Saudi Arabia

UK

0845 8503392

Bedford

Ukraine

+38 044 391 37 56 (57)

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