User Manual
209 Pages
![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 Vscan – User Manual GM092102 04 i-5](https://images.bioclinicalservices.com.au/2bfhKrgxLvjGs7WTHQxaJjrU/320w/GE%20Healthcare%20-%20GM092102%20-%20Vscan%20User%20Manual%20Ver%201.x%20Rev%2004%20-%202010-08.png)
Preview
Page 1
GE Healthcare
Technical Publications Vscan Version 1.x.x User Manual GM092102 - English Rev. 04 Operating Documentation Copyright © 2010 By General Electric Co.
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
Vscan – User Manual GM092102 04
i-1
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.
i-2
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.
i-3
i-4
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
Vscan – User Manual GM092102 04
i-5
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
i-6
Vscan – User Manual GM092102 04
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
Vscan – User Manual GM092102 04
i-7
i-8
Vscan – User Manual GM092102 04
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
Vscan – User Manual GM092102 04
1-1
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.
1-2
Vscan – User Manual GM092102 04
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.
Vscan – User Manual GM092102 04
1-3
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.
Vscan – User Manual GM092102 04
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.
1-5
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:
1-6
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.
Vscan – User Manual GM092102 04
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.
Vscan – User Manual GM092102 04
1-7
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.
1-8
Vscan – User Manual GM092102 04
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
Vscan – User Manual GM092102 04
Vienna
1-9
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)
1-10
Vscan – User Manual GM092102 04