Technical Publications
Technical PublicationsVscanVersion 1User ManualGM092207 — EnglishRev. 02Operating DocumentationCopyright 2014 By General Electric Co.
Regulatory requirementThis product complies with regulatory requirements of the following EuropeanDirective 93/42/EEC concerning medical devices.This manual is a reference for the Vscan. It applies to all sub-versions of thesoftware version 1 for the Vscan ultrasound system unless otherwise specified.This manual is a reference for the Vscan gateway software. It applies to allsub-versions of the software version 1 for the Vscan gateway software unlessotherwise specified.Manual status:GM092207-0226 February 2014Manufacturer:GE VINGMED ULTRASOUND ASStrandpromenaden 45N-3191 Horten, NorwayTel.: ( 47) 3302 1100 Fax: ( 47) 3302 1350
Regulatory RequirementsConformance StandardsThe GE product families are tested to meet all applicablerequirements in relevant EU Directives and European/International standards. Any changes to accessories, peripheralunits or any other part of the system must be approved by themanufacturer: GE Vingmed Ultrasound. Ignoring this advicemay compromise the regulatory approvals obtained for theproduct.This product complies with the regulatory requirement of al Devices Directive (MDD)EN55011Emitted noise according to Class B 2.2 No 601.1-M90Medical Electrical Equipment, Part 1; General Requirementsfor SafetyIEC60601-2-37Medical electrical equipment - Part 2-37. Particularrequirements for the safety of ultrasonic medical diagnosticand monitoring equipmentIEC1157 / EN61157Requirements for the declaration of the acoustic output ofmedical diagnostic ultrasonic equipment.IEC60601-1-2EN60601-1-2Medical Electrical Equipment - part 1-2. Collateral standard:Electromagnetic compatibility - Requirements and tests.IEC60601-1-4EN60601-1-4Medical Electrical Equipment - part 1-4. Collateral standard:Programmable electrical medical systemsIEC60601-1-6Medical Electrical Equipment - part 1-6. Collateral standard:Usability.NEMA/AIUM UD-3Standard for real-time display of thermal and mechanicalacoustic output indices on diagnostic ultrasound equipment.ISO10993-1Biological evaluation of medical devicesVscan – User ManualGM092207 02i-1
Country Specific Approvals JAPANMHLW Approved Number: 221ABBZX00252000 CHINASFDA: SFDA (I) 20113231266Product Standard Number: YZB/NOR 0732-2011 KOREAKFDA: 10-1194Certifications GE Vingmed Ultrasound is ISO 9001 and ISO 13485certified.ClassificationsThe 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 handheld 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: ordinaryequipment (IPx0)Probe tip: IPX1Class II EquipmentEQUIPMENT in which protection against electric shock does notrely on BASIC INSULATION only, but in which additional safetyprecautions such as DOUBLE INSULATION or REINFORCEDINSULATION are provided, there being no provision forprotective earthing or reliance upon installation conditions.i-2Vscan – User ManualGM092207 02
Type BF Applied partTYPE BF APPLIED PART providing a specified degree ofprotection against electric shock, with particular regard toallowable LEAKAGE CURRENT.Normal modePatient leakage current 100 microASingle fault condition 500 microAEnvironmental requirements for the r PressureOperational10–40 C30–80%700–1060 hPaNon operational-20–70 C30–90%700–1060 hPaNOTE:Avoid exposing the unit to saline moisture. In case of exposureto saline moisture, clean the unit as described on page 6-4.Original Documentation Vscan – User ManualGM092207 02The original document was written in English.i-3
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Table of ContentsConformance Standards - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-1Country Specific Approvals - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-2Certifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-2Classifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-2Class II Equipment - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-2Type BF Applied part - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-3Environmental requirements for the unit - - - - - - - - - - - - - - - - - - - - - - - - i-3Original Documentation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-3Table of ContentsChapter 1 — IntroductionGeneral descriptionPrinciples of operation- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Indication for use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Contraindication - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -1-21-21-31-3WarningsConventions used in this manualContact InformationContacting GE Ultrasound - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-7Global ultrasound support center phone numbers - - - - - - - - - - - - - - - - 1-8Manufacturer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-11Chapter 2 — Preparing the Vscan for usePackage contentsSystem descriptionSystem overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-5BatteryPower plug adapter- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Charging the battery using the Docking station - - - - - - - - - - - - - - - - Charging the battery using the External batterycharging compartment- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Battery level indicator - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Removing / inserting the battery (GM-BAT) - - - - - - - - - - - - - - - - - - - Battery (GM-BAT) specifications - - - - - - - - - - - - - - - - - - - - - - - - - - -2-122-122-132-142-152-16The microSD cardRemoving / inserting the microSD card - - - - - - - - - - - - - - - - - - - - - - - 2-17The microSD card memory indicator- - - - - - - - - - - - - - - - - - - - - - - - - 2-19The microSD card handling recommendations- - - - - - - - - - - - - - - - - - 2-20First time useInstalling the battery - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-21Vscan – User ManualGM092207 02i-5
Vscan activationActivation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-22Configuration - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-22Chapter 3 — Using VscanSwitching on/offTo switch on the Vscan - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-2To switch off the Vscan - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-2ScanningGeneral scanning recommendations- - - - - - - - - - - - - - - - - - - - - - - - - Probe orientation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Patient examination - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Presets - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Black and white imaging - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Color imaging - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Auto freeze - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - AutoCycle - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -3-33-53-53-63-63-73-83-8MeasurementsTaking measurements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-9Voice notationsRecording Voice notations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-10Review and storageReviewing acquired images - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-11Storage of images- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-11Recall of stored dataDeletion of dataTo delete an examination - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-14To delete a file - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-14Chapter 4 — Vscan gateway softwareOverviewAbout the files created in Vscan - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-2Vscan gateway software installationComputer requirements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-4Installation and activation of Vscan gateway software - - - - - - - - - - - - - 4-5Connection of Vscan to a computerUsing Vscan gateway softwareOverview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-20Gallery screen - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-21Setup screen - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-28Chapter 5 — Vscan configurationConfig menuSystem setup adjustment - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-3Chapter 6 — Vscan maintenanceSystem care and maintenanceInspectionInspecting the Vscan- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-3Inspecting the probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-3i-6Vscan – User ManualGM092207 02
Cleaning and disinfectionCleaning - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-4Disinfection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-5Reinstallation of the factory softwareProcedure - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-7TroubleshootingVscan troubleshooting- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-9Vscan gateway software troubleshooting - - - - - - - - - - - - - - - - - - - - - 6-10Chapter 7 — SafetyIntroductionOwner responsibilityNotice against user modification- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-3Important safety considerationsPatient safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-5Personnel and equipment safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-7Electromagnetic Compatibility (EMC) - - - - - - - - - - - - - - - - - - - - - - - - - 7-9Acoustic output- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-16Environmental protection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-18Probe overviewMaximum probe temperatureDevice labels and symbolsChapter 8 — AppendixAcoustic Output Reporting TablesDefinitions, symbols and abbreviations - - - - - - - - - - - - - - - - - - - - - - - - 8-2Acoustic Output Reporting Tables for Track 3/IEC 60601-2-37 - - - - - - - 8-5Measurement accuracyDistance measurement - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-7Area measurement - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-7Medical Ultrasound SafetyIndexVscan – User ManualGM092207 02i-7
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Chapter 1IntroductionContents:‘General description’ on page 1-2‘Warnings’ on page 1-4‘Conventions used in this manual’ on page 1-6‘Contact Information’ on page 1-7Vscan – User ManualGM092207 021-1
IntroductionGeneral descriptionVscan is a battery operated pocket-sized general purposeultrasound imaging system.Principles of operationMedical ultrasound images are created by computer and digitalmemory from the transmission and reception of mechanicalhigh-frequency waves applied through a probe. The mechanicalultrasound waves spread through the body, producing an echowhere density changes occur. The echoes return to the probewhere they are converted back into electrical signals.These echo signals are amplified and processed by severalanalog and digital circuits having filters with many frequency andtime response options, transforming the high-frequencyelectrical signals into a series of digital image signals which arestored in memory. Once in memory, the image can be displayedin real-time on the image monitor.A probe is an accurate, solid-state device, providing multipleimage formats. The digital design and use of solid-statecomponents provides highly stable and consistent imagingperformance with minimal required maintenance. Sophisticateddesign with computer control offers a system with extensivefeatures and functions which is user-friendly and easy to use.SafetyRead and understand all instructions in the User's Manualbefore attempting to use the ultrasound unit. Keep the manualwith the equipment at all time. Periodically review theprocedures for operation and safety precautions.All information in Chapter ‘Safety’ on page 7-1 should beread and understood before operating the ultrasound unit.1-2Vscan – User ManualGM092207 02
General descriptionIndication for useThe Vscan ultrasound unit is intended for the followingapplications: Cardiac adult and pediatric Abdominal Pediatric Urology Fetal Peripheral vascular Thoracic/Pleural motion and fluid detectionContraindicationThe Vscan ultrasound unit is not intended for ophthalmic use orany use causing the acoustic beam to pass through the eye.CAUTIONFor USA only:United States law restricts this device to sale or use by, or onthe order of a physician.Vscan – User ManualGM092207 021-3
IntroductionWarningsTo prevent damage of the equipment or injury to yourself orothers, read the following safety warnings before using theVscan.WARNING1-4 Vscan is a precision instrument. Handle Vscan and itsaccessories with care. Do not subject Vscan to mechanicalshock or impact. Do not attempt to disassemble or alter any part of the unitincluding the probe, the battery, the AC/DC adapter andaccessories. Disassembly or modification may result inelectrical 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 theprobe. 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 andcharger). Failure to do so may result in electrical shock orfire. Do not place the battery near a heat source or expose it todirect flame. Such exposure may lead to corrosive liquidleakage, electrical shock or fire. If any liquid from battery should come in contact with theeye, immediately wash the eye with plenty of water andseek 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 unplugthe 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 couldresult in electrical shock, corrosive liquid leakage andinjury.Vscan – User ManualGM092207 02
WarningsWARNINGVscan – User ManualGM092207 02 Do not short-circuit the battery terminal with metallicobjects. This may result in overheating and burns. Do not store or carry a battery loosely with metallicdevices. Disconnect the battery charger when not in use to avoidfire hazard. Keep the charger dry. Failure to observe this precautionmay result in fire and electric shock Keep this unit out of reach of children.1-5
IntroductionConventions used in this manualButtons and other controls on the Control panel or on themonitor screen are indicated by bold type.Program windows, screens and Dialogue boxes are indicated byitalic type.The following icons, highlight safety issues as follow:1-6DANGERIndicates that a specific hazard exists that, given inappropriateconditions or actions, will cause severe or fatal personal injurywith or without substantial property damage.WARNINGIndicates that a specific hazard exists that, given inappropriateconditions or actions, can cause severe or fatal personal injurywith or without substantial property damage.CAUTIONIndicates that a potential hazard may exist that, giveninappropriate conditions or actions, can cause minor injury orproperty damage.Vscan – User ManualGM092207 02
Contact InformationContact InformationContacting GE UltrasoundFor additional information or assistance, please contact yourlocal distributor or the appropriate support resource listed on thefollowing /www.gehealthcare.comUSAGE HealthcareTEL: (1) 800-437-1171Ultrasound Service EngineeringFAX: (1) 414-721-38659900 Innovation DriveWauwatosa, WI 53226Clinical QuestionsPlease contact your local Applications or Sales Representative.Accessories Catalog RequestsTo request the latest GE Accessories catalog or equipmentbrochures in the United States, call the Response CenterTEL: (1) 800-643-6439In other locations, contact your local Applications, Sales orService Representative.Placing an orderTo place an order, order supplies or ask an accessory-relatedquestion in the United States, call the GE Access CenterVscan – User ManualGM092207 021-7
IntroductionTEL: (1) 800-472-3666In other locations, contact your local Applications, Sales orService Representative.Global ultrasound support center phone numbersFor countries not listed in the tables below, please contact thelocal distributor.When contacting Support you will have to provide yoursystem ID. If system ID is unknown, please give the TemporarySystem ID “VSCAN” to be properly routed for support.AmericasRegionTelephoneLocationUnited onMexico0800 9043400Sao PauloPuerto Rico0800 4371171Sao PauloBrazil0800 122345Sao PauloArgentina0800 3331984Sao PauloChile0800 367000Sao Paulo1-8Vscan – User ManualGM092207 02
Contact InformationEurope, Middle East and AfricaRegionTelephoneLocationAlgeria 21321484612Andorra902 400 246Austria0800244260ViennaBelgium Dutch 32 262 638 38DiegemBelgium French 32 262 638 39DiegemBulgarian 35929712040SofiaDenmark80404944StockholmEgypt 202 19434 [hot 40VelizyG. D. nGreece302109690660AthensHoly See800 827168MilanHungary Contact local distributorTel AvivItaly Central800 827168MilanItaly North-East800 827166MilanItaly North-West800 827164MilanItaly South800 827170MilanLiechtenstein0041 44 809 thern rtugal800 834 004MadridRussia 7 495 739 69 75MoscowSan Marino800 827168MilanSaudi Arabia800 1243002Saudi ArabiaVscan – User ManualGM092207 021-9
IntroductionRegionTelephoneLocationSouth Africa800 111 671South AfricaSpain902 400 56958ZurichTurkeyContact local distributorIstanbulUAE800 3646Saudi ArabiaUK0845 8503392BedfordUkraine 38 044 391 37 56 (57)1-10Vscan – User ManualGM092207 02
Contact InformationAsia and ngHong Kong(852) 21006288Hong KongTaiwan0800-021-770TaipeiIndia(91) 1800-425-8025BangaloreSingapore(65) 62773444SingaporeAustralia1-800-659-465BrisbaneNew Zealand0800 65 94 65BrisbaneJapan0120-055-919TokyoKorea(82) 2-1544-6119SeoulBangladesh(880) 29135488DhakaSri Lanka(94) 114891178ColomboBhutanContact GE IndiaMaldivesContact GE IndiaNepalContact local distributorMalaysia1800 88 3911Kuala LumpurThailand(66) 26248400BangkokVietnamContact local distributorPhilippinesContac
1-6 Vscan – User Manual GM092207 02 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: DANGER
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