GE Healthcare VSCANEXTEND VSCAN EXTEND User Manual VSE UM 5721203 D 00

GE Healthcare VSCAN EXTEND VSE UM 5721203 D 00

Contents

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Manual

Technical PublicationsVscan Extend™Version 1.0User Manual5721203-100 — EnglishRev. DOperating DocumentationCopyright © 2016 By General Electric Co.
Regulatory requirementThis 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/SStrandpromenaden 453191 Horten, NorwayTel.: (+47) 3302 1100 Fax: (+47) 3302 1350
Vscan Extend – User Manual i-15721203-100 Rev. DRevision HistoryReason for ChangePlease 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. REV DATE (YYYY/MM/DD) REASON FOR CHANGERev. A 2016/04/05 Initial draftRev. B 2016/05/19 Included External Battery charger labelIncluded Power button under device labelsIncluded revised rating labelIncluded sections in Privacy and Security chapterRev. C 2016/06/01 Removed breast and testes from indication of use statementIncluded the revised rating label, battery label and external charger labelIncluded the scope for all the standards in Table i-1Rev. D 2016/08/18 Included IP33, Ophthalmic and Aorta presets, IEC 60601-11 and 12 standards, Tricefy App
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Vscan Extend – User Manual i-35721203-100 Rev. DRegulatory RequirementsConformance StandardsThe 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 obtained for the product.This product complies with the regulatory requirement of the following:Table i-1: Regulatory RequirementsStandard/Directive Scope93/42/EEC Medical Devices Directive (MDD)2007/47/EC (MDD amendment)Directive 2011/65/EU RoHS2002/96/EC WEEEThe 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 measurementIEC* 60601-1CAN/CSA-C22.2 No 601.1Medical Electrical Equipment, Part 1; General Requirements for SafetyIEC* 60601-2-37 Medical electrical equipment - Part 2-37. Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipmentIEC* 60601-1-2 Medical Electrical Equipment - part 1-2. Collateral standard: Electromagnetic compatibility - Requirements and tests.IEC* 60601-1-4 Medical Electrical Equipment - part 1-4. Collateral standard: Programmable electrical medical systemsIEC* 60601-1-6 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.
i-4 Vscan Extend – User Manual5721203-100 Rev. DCertifications• GE Vingmed Ultrasound is ISO 13485 certified.ISO10993-1 Biological evaluation of medical devicesEN 300 328 Electromagnetic compatibility and Radio spectrum Matters (ERM); Wideband transmission systemsISO 14971 Medical devices - Application of risk management to medical devicesIEC* 62304 Medical device software - Software life-cycle processesIEC* 62366 Medical devices - Application of usability engineering to medical devicesIEC* 60601-1-11 Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environmentIEC* 60601-1-12 Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment* including national deviationsTable i-1: Regulatory Requirements (Continued)Standard/Directive Scope
Vscan Extend – User Manual i-55721203-100 Rev. DClassificationsThe 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 BF Applied 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.Class II EquipmentEQUIPMENT 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 partTYPE BF APPLIED PART providing a specified degree of protection against electric shock, with particular regard to allowable LEAKAGE CURRENT.Original Documentation• The original document was written in English. Table i-2: Leakage CurrentNormal mode Single fault conditionPatient leakage current <100 microA <500 microA
i-6 Vscan Extend – User Manual5721203-100 Rev. DCountry Specific Approval• USA AND TERRITORIES• JAPAN• CHINAImporter InformationTurkeyDANGER The following optional feature IS NOT available in the USA and its territories:– OphthalmalicDANGER The following optional feature IS NOT available in JAPAN:– OphthalmalicDANGER The following optional feature IS NOT available in CHINA:– Ophthalmalic
Vscan Extend – User Manual i-75721203-100 Rev. DTable of ContentsConformance Standards - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-3Certifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-4Classifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-5Class II Equipment - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-5Type BF Applied part - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-5Original Documentation- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-5Country Specific Approval - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-6Importer Information - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-6Table of ContentsChapter 1 — IntroductionOverviewAttention - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-2General description- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-2Principles of operation- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3Intended use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3Indications for use (for all countries except USA, China and Japan)- - - - 1-4Indications for use (for USA, China and Japan) - - - - - - - - - - - - - - - - - - 1-5Contraindication for use (for USA, China and Japan) - - - - - - - - - - - - - - 1-5Intended users - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-6Prescription Device- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-6Operator profile - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-6WarningsImportant Safety Considerations - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-7Contact Information Contacting GE Ultrasound - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-10Global ultrasound support center phone numbers - - - - - - - - - - - - - - - 1-11Manufacturer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-14Chapter 2 — SafetyIntroductionOverview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-2Owner responsibilityOverview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-3Notice against user modification- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-4Important safety considerationsOverview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-5Patient Safety- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-5Diagnostic information- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-6
i-8 Vscan Extend – User Manual5721203-100 Rev. DGeneral precautionary advice for the use of diagnostic ultrasound in combination with ultrasound contrast agents - - - - - - - - - - - - - - - - - 2-6Mechanical hazards - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-6Electrical hazard- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-7Personnel and equipment safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-7Explosion hazard - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-7Electrical hazard- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-8Electromagnetic Compatibility (EMC) - - - - - - - - - - - - - - - - - - - - - - - - 2-10Electromagnetic emissions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-14Electromagnetic immunity - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-14Separation distances- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-18Essential Performance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-18Acoustic output- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-19Environmental protection- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-23Maximum probe temperatureDevice labels and symbolsVscan Extend Labels (Example)- - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-25Explanation of the Pollution control label for China- - - - - - - - - - - - - - - 2-29Chapter 3 — Preparing Vscan Extend for Use Package contentsVscan Extend package contents - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-2Environmental requirementsEnvironmental requirements for the device - - - - - - - - - - - - - - - - - - - - - 3-3System descriptionSystem overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-4Accessories and Configurations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-7External battery charger compartment (option) - - - - - - - - - - - - - - - - - 3-11Display screens - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-12Vscan Extend BatteryBattery- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-15Initial useFirst time use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-22Power on/off- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-22Vscan Extend activation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-24Chapter 4 — Vscan Extend SettingsSettingsScan Settings - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-2Server Settings- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-3Diagnostics - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-12System Settings - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-13Administrator Access - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-15Storage Access - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-17Wi-Fi - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-21Configuring Wi-Fi - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-23MDM Installation Procedures (Optional) - - - - - - - - - - - - - - - - - - - - - - 4-24Certificate Authority- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-28GE Marketplace - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-31
Vscan Extend – User Manual i-95721203-100 Rev. DChapter 5 — Using Vscan Extend ScanningGeneral scanning recommendations- - - - - - - - - - - - - - - - - - - - - - - - - - 5-2Black and white imaging - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-17Color imaging- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-20Auto freeze - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-23AutoCycle - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-23Use of sterile sheath - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-23MeasurementsTaking measurements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-24Review and recall of stored dataBackups Recommended - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-26Reviewing and recalling images or videos from an exam list - - - - - - - - 5-26Deletion of data - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-28Data Export - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-30Backup - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-42Restore - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-45Using Vscan Extend AppsOverview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-47Bladder Volume - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-47Lung Protocol- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-54Tricefy - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-62Chapter 6 — Vscan Extend MaintenanceSystem care and maintenanceOverview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-2Inspection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-3Cleaning and disinfectionCleaning the device - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-4Method of cleaning: Manual - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-6Disinfecting the device - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-7Disinfecting the probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-9Rinsing and Lubricating Agents - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-11Upgrade softwareScanner software - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-12TroubleshootingVscan Extend troubleshooting - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-14System Warning Messages - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-16Chapter 7 — AppendixSpecificationsDimension and weight- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-2Phased array transducer for deep scanning - - - - - - - - - - - - - - - - - - - - 7-2Linear transducer for shallow scanning - - - - - - - - - - - - - - - - - - - - - - - - 7-2Acoustic Output Reporting TablesDefinitions, symbols and abbreviations - - - - - - - - - - - - - - - - - - - - - - - - 7-3Acoustic Output Reporting Tables for Track 3/EN/IEC 60601-2-37 - - - - 7-6Measurement accuracyBasic Measurements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-12
i-10 Vscan Extend – User Manual5721203-100 Rev. DChapter 8 — Privacy and SecurityIntroductionOverview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-2How to contact GE - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-2Privacy and Security Environment - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-3Network ConnectivityOverview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-6System interconnections - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-6Network Requirements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-8Network Protocols- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-8Information ProtectionOverview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-9Network Security - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-9System ProtectionVscan Extend – system protection - - - - - - - - - - - - - - - - - - - - - - - - - - 8-16Personal Information Collected by the ProductInformation collection and use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-17Manual information collection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-18Information disclosure - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-19Retention and destruction of personal information - - - - - - - - - - - - - - - 8-19Potential Hazardous Situations Resulting From Failures of the IT Network- - 8-21Index
Vscan Extend – User Manual 1-15721203-100 Rev. DChapter 1IntroductionContents:‘Overview’ on page 1-2‘Warnings’ on page 1-7‘Contact Information’ on page 1-10
Introduction1-2 Vscan Extend – User Manual5721203-100 Rev. DOverviewAttentionThis manual covers the following two configurations of the Vscan Extend. Refer to the relevant section based on the configuration purchased.• Vscan ExtendTM configured with a sector probe allowing deep scanning (holding the phased array transducer G3S)• Vscan ExtendTM configured with a Dual Probe allowing 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.General descriptionVscan 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.
OverviewVscan Extend – User Manual 1-35721203-100 Rev. DPrinciples of operationMedical 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.SafetyRead 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.Intended useVscan 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.
Introduction1-4 Vscan Extend – User Manual5721203-100 Rev. DIndications 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 with other medical 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 the 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.
OverviewVscan Extend – User Manual 1-55721203-100 Rev. DIndications for use (for 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 with other medical 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); and Pediatrics.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.
Introduction1-6 Vscan Extend – User Manual5721203-100 Rev. DIntended usersVscan 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 practices 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.Prescription DeviceFor USA only:CAUTION: Federal law restricts this device to sale by or on the order of a physician.Operator profileQualified and trained healthcare professionals with at least a basic level of general ultrasound training that includes limited image acquisition techniques and interpretation (i.e. position the probe correctly on the patient and determine at least normal vs. abnormal anatomy views during scanning).Contact GE sales representative for product training assistance and visit the Vscan web portal for reference materials.CAUTION The operator must read and understand the user manual.
WarningsVscan Extend – User Manual 1-75721203-100 Rev. DWarningsImportant Safety ConsiderationsTo prevent damage of the equipment or injury to yourself or others, read the following safety warnings before using Vscan Extend.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.
Introduction1-8 Vscan Extend – User Manual5721203-100 Rev. DImportant Safety Considerations (continued)Before charging or using a battery it is important that you read and understand the battery safety and environment information.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.WARNING • Do not damage the rechargeable battery. A damaged battery can cause an explosion or fire, and can result 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 battery fluid. Do not 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.
WarningsVscan Extend – User Manual 1-95721203-100 Rev. DImportant Safety Considerations (continued)WARNING 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.CAUTION • 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 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.
Introduction1-10 Vscan Extend – User Manual5721203-100 Rev. DContact InformationContacting GE UltrasoundFor additional information or assistance, please contact your local distributor or the appropriate support resource listed on the following pages:Internethttps://vscan.gehealthcare.comhttp://www.gehealthcare.comUSATEL: (1) 800-437-1171Ultrasound Service Engineering9900 Innovation DriveWauwatosa, WI 53226Clinical QuestionsPlease contact your local Applications or Sales Representative. Service QuestionsFor service contact your local Service Representative.
Contact InformationVscan Extend – User Manual 1-115721203-100 Rev. DAccessories Catalog RequestsTo request the latest GE Accessories catalog or equipment brochures in the United States, call the Response CenterTEL: (1) 800-643-6439In other locations, contact your local Applications, Sales or Service Representative. Placing an orderTo place an order, order supplies or ask an accessory-related question in the United States, call the GE Access CenterTEL: (1) 800-472-3666In other locations, contact your local Applications, Sales or Service Representative.Global ultrasound support center phone numbersFor countries not listed in the tables below, please contact the local distributor.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.AmericasTable 1-1: AmericasRegion TelephoneUnited States1800-437-1171Canada 800-668-0732Mexico 0800 9043400Puerto Rico 0800 4371171Brazil 0800 122345Argentina 0800 3331984Chile 0800 3670001 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.
Introduction1-12 Vscan Extend – User Manual5721203-100 Rev. DEurope, Middle East and AfricaTable 1-2: Europe, Middle East and AfricaRegion TelephoneAlgeria +21321484612Andorra 902 400 246Austria 0800244260Belgium Dutch +32 262 638 38Belgium French +32 262 638 39Bulgarian +35929712040Denmark 80404944Egypt +202 19434 [hot line]Finland 0981710182France 0800139140G. D. Luxembourg 080022973Germany 08004373784Greece 302109690660Holy See 800 827168Hungary +36-23-410-510Ireland 1800992557Israel Contact local distributorItaly Central 800 827168Italy North-East 800 827166Italy North-West 800 827164Italy South 800 827170Liechtenstein 0041 44 809 9293Monaco 0800139140Netherlands 8000994442Northern Ireland 08000720248Norway 80062043Portugal 800 834 004Russia +7 495 739 69 75San Marino 800 827168
Contact InformationVscan Extend – User Manual 1-135721203-100 Rev. DSaudi Arabia 800 1243002South Africa 800 111 671Spain 902 400 246Sweden 0201201436Switzerland 0800556958Turkey Contact local distributorUAE 800 3646UK 0845 8503392Ukraine +38 044 391 37 56 (57)Table 1-2: Europe, Middle East and Africa (Continued)Region Telephone
Introduction1-14 Vscan Extend – User Manual5721203-100 Rev. DAsia and PacificManufacturerGE VINGMED ULTRASOUND A/SStrandpromenaden 453191 Horten, NorwayTEL: (+47) 3302 1100; FAX: (+47) 3302 1350Table 1-3: Asia and PacificRegion TelephoneChina 8008108188Hong Kong (852) 21006288Taiwan 0800-021-770India (91) 1800-425-8025Singapore (65) 62773444Australia 1-800-659-465New Zealand 0800 65 94 65Japan 0120-055-919Korea (82) 2-1544-6119Bangladesh (880) 29135488Sri Lanka (94) 114891178Bhutan Contact GE IndiaMaldives Contact GE IndiaNepal Contact local distributorMalaysia 1800 88 3911Thailand (66) 26248400Vietnam Contact local distributorPhilippines Contact local distributorIndonesia Contact local distributorLaos Contact local distributorBrunei Darussalam Contact local distributorCambodia Contact local distributor
Vscan Extend – User Manual 2-15721203-100 Rev. DChapter 2SafetyContents:‘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
Safety2-2 Vscan Extend – User Manual5721203-100 Rev. DIntroductionOverviewThis 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 found 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 precautions:DANGER 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.WARNING Indicates that a specific hazard is known to exist which through inappropriate conditions or actions may cause:• Severe personal injury• Substantial property damage.CAUTION Indicates that a potential hazard may exist which through inappropriate conditions or actions will or can cause:• Minor injury• Property damage.
Owner responsibilityVscan Extend – User Manual 2-35721203-100 Rev. DOwner responsibilityOverviewIt 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 undertake 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.
Safety2-4 Vscan Extend – User Manual5721203-100 Rev. DOverview (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. Before configuring the servers, the owner of the Vscan Extend MUST abide by the applicable privacy acts specific to their region or country.Notice against user modificationNever 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.CAUTION For USA only:Federal law restricts this device to sale by or on the order of a physician.CAUTION Vscan Extend should be used in compliance with law. Some jurisdictions restrict certain uses, such as gender determination.
Important safety considerationsVscan Extend – User Manual 2-55721203-100 Rev. DImportant safety considerationsOverviewThis section includes considerations for the following:• Patient safety• Personnel and equipment safetyThe 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 SafetyPatient identificationAlways 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.WARNING The concerns listed in this section can seriously affect the safety of the patient undergoing a diagnostic ultrasound examination.CAUTION 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.
Safety2-6 Vscan Extend – User Manual5721203-100 Rev. DDiagnostic informationThe 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 decision based 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 details 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.General precautionary advice for the use of diagnostic ultrasound in combination with ultrasound contrast agentsMechanical hazardsA 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).CAUTION Avoid reflections from windows/lamps/direct sunlight on the display. Avoid analyzing data from small viewing angles.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.
Important safety considerationsVscan Extend – User Manual 2-75721203-100 Rev. DElectrical hazardA 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 damage 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 safetyExplosion hazardNever 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 off the Vscan Extend, or to unplug it.• If flammable substances are detected, evacuate and ventilate the area before turning off Vscan Extend.DANGER The hazards listed below can seriously affect the safety of personnel and equipment during a diagnostic ultrasound examination.
Safety2-8 Vscan Extend – User Manual5721203-100 Rev. DElectrical hazardNOTE: Any rest energy within our scanners or their components will be below 60 V DC or 2 mJ.To avoid injury• 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. Pacemaker hazardThe 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 SafetyDevice classificationsVscan Extend is an internally powered device, type BF.The AC/DC adapter is Class II.WARNING The internal circuits of the AC/DC adapter use high voltages, capable of causing serious injury or death by electrical shock.
Important safety considerationsVscan Extend – User Manual 2-95721203-100 Rev. DExternal Connection Figure 2-1. Patient environmentAllergic reactions to latex-containing medical devicesDue 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.CAUTION 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).1. Patient environment
Safety2-10 Vscan Extend – User Manual5721203-100 Rev. DElectromagnetic 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 other 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 cables not properly 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.
Important safety considerationsVscan Extend – User Manual 2-115721203-100 Rev. DElectromagnetic 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 the ultrasound 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 should be attentive 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 statements1. This device may not cause harmful interference, and2. This device must accept any interference received, including Interference that may cause undesired operation.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.
Safety2-12 Vscan Extend – User Manual5721203-100 Rev. DFCC 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 televisionReception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the 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, and2. 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, et2. l'utilisateur de l'appareil doit accepter tout brouillage adioélectrique subi, même si le brouillage est susceptible d'en compromettre le fonctionnement.
Important safety considerationsVscan Extend – User Manual 2-135721203-100 Rev. DFCC compliance statements for Canada (French translation) (continued)This equipment complies with radio frequency exposure limits 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 radiofréquencesdéfinies 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.
Safety2-14 Vscan Extend – User Manual5721203-100 Rev. DElectromagnetic emissionsElectromagnetic immunityTable 2-1: Electromagnetic emissionsGuidance and manufacturer’s declaration – electromagnetic emissions.Emissions test Compliance Electromagnetic environment - guidanceRF emissionEN55011Group 1Class BThe 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.RF emissionEN55011Group 1Class BThe 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.Harmonic emissionEN 61000-3-2CompliesVoltage fluctuations/flicker emissions EN/IEC 61000-3-3CompliesTable 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.Immunity test EN 60601test level Compliance levelElectromagnetic environment –guidanceElectrostatic discharge (ESD)EN 61000-4-2±6 kV contact±8 kV air±6 kV±8 kVFloors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.Electrical fast transient/ burstEN 61000-4-4±2 kV for power-supply lines±1 kV for input/output lines±2 kV for power-supply lines±1 kV for input/output linesMains power quality should be that of a typical commercial or hospital environment.SurgeEN 61000-4-5±1 kV line(s) to line(s) ±1 kV line(s) to line(s)Mains power quality should be that of a typical commercial or hospital environment.
Important safety considerationsVscan Extend – User Manual 2-155721203-100 Rev. DVoltage dips, short interruptions and voltage variations on power supply input lines EN 61000-4-115% UT (>95% dip in UT) for 0,5 cycle40% UT(60% dip in UT) for 5 cycles70% UT (30% dip in UT) for 25 cycles< 5% UT (>95% dip in UT) for 5 s5% UT (>95% dip in UT) for 0,5 cycle40% UT(60% dip in UT) for 5 cycles70% UT (30% dip in UT) for 25 cycles< 5% UT (>95% dip in UT) for 5 sMains 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.Power frequency (50/60 Hz) magnetic fieldEN/IEC 61000-4-83 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.NOTE: UT is the a. c. mains voltage prior to application of the test level.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.Immunity test EN 60601test level Compliance levelElectromagnetic environment –guidance
Safety2-16 Vscan Extend – User Manual5721203-100 Rev. DElectromagnetic immunity (continued)Table 2-3: Electromagnetic immunity (Part 2)Guidance and manufacturer’s declaration – electromagnetic immunity – for all medical electrical equipment and medical electrical systems that not life-supportingThe 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 IEC 60601 test level Compliance levelElectromagneticenvironment – guidancecConducted RFEN 61000-4-6Radiated RFEN 61000-4-33Vrms 150 kHz to 80 MHz3 V/m80 Mhz to 2,5 GHz3V3 V/mPortable 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 distance80 MHz to 800 MHz800 MHz to 2.5 GHzwhere 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,a should be less than the compliance level in each frequency range.bInterference may occur in the vicinity of equipment marked with the following symbolNOTE 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.
Important safety considerationsVscan Extend – User Manual 2-175721203-100 Rev. Da 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.b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.Table 2-3: Electromagnetic immunity (Part 2) (Continued)Guidance and manufacturer’s declaration – electromagnetic immunity – for all medical electrical equipment and medical electrical systems that not life-supportingThe 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 IEC 60601 test level Compliance levelElectromagneticenvironment – guidancec
Safety2-18 Vscan Extend – User Manual5721203-100 Rev. DSeparation distancesEssential PerformanceThe 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.Table 2-4: Separation distancesRecommended 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 W150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz0,01 0,12 0,12 0,230,1 0,38 0,38 0,731 1,2 1,2 2,310 3,8 3,8 7,3100 12 12 23For 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.
Important safety considerationsVscan Extend – User Manual 2-195721203-100 Rev. DAcoustic outputDefinition of the acoustic output parametersThermal IndexTI 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-Time 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 equipmentMechanical IndexMI 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.IsptaThe Ispta is the Spatial Peak Temporal Average Intensity. The absolute maximum limit of Ispta is 720 mW/cm2 as set by the FDA guidance of September 9, 2008 for diagnostic ultrasound systems and transducers.
Safety2-20 Vscan Extend – User Manual5721203-100 Rev. DAcoustic output and display on Vscan ExtendMI 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/cm2.Display Accuracy and Acoustic Measurement UncertaintiesThe 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 assessed by determining both the random and the systematic uncertainties and given in percent at 95% confidence level.a. Accuracy = (Measured value - displayed value)/displayed value * 100%Table 2-5: Display accuracyParameter Estimated accuracyaMeasurement precisionblack and white/colorPressure, MI ±25% ±15%Power, TI ±50% ±40%
Important safety considerationsVscan Extend – User Manual 2-215721203-100 Rev. DSystem controls affecting acoustic outputThe 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 when the maximum 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 Obstetric scanningGeneral Abdominal, *Peripheral Vascular, Adult cephalic, Musculoskeletal, cardiac and other scanningTI time TI time Note0.0–0.7 Unlimited 0.0–1.0 Unlimited Monitor TI0.7–1.0 < 60 min 1.0–1.5 < 120 min1.0–1.5 < 30 min 1.5–2.0 < 60 min1.5–2.0 < 15 min 2.0–2.5 < 15 min2.0–2.5 < 4 min 2.5–3.0 < 4 min2.5–3.0 < 1 min*Peripheral vascular is applicable for only dual probeReferences• 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.
Safety2-22 Vscan Extend – User Manual5721203-100 Rev. DApplication selectionSelecting the application appropriate to a particular ultrasound examination automatically provides acoustic output limits within FDA guidances for that application. Other parameters which optimize performance for the selected application are also set automatically, and should assist in reducing the patient exposure time.Changing imaging modesAcoustic output depends on the imaging mode selected. This greatly affects the energy 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).ALARAUltrasound 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 generally 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.
Important safety considerationsVscan Extend – User Manual 2-235721203-100 Rev. DALARA (continued)To contact the AIUM concerning their publications:• In the USA, by telephone at 1-800-638-5352• To write them, use the following address:AIUM14750 Sweitzer LaneSuite 100Laurel, MD, USA 20707-5906In 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.TrainingDuring 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 protectionSystem disposalThe 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.
Safety2-24 Vscan Extend – User Manual5721203-100 Rev. DMaximum probe temperatureThe table below indicates the maximum probe temperature.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.Table 2-7: Maximum probe temperatureProbe Max Temp in deg C(Simulated use) Max Temp in deg C(Still air)Vscan Extend – configured with Sector probe:Phased array transducer (G3S) for Deep scanning 39.7 43.1Vscan Extend – configured with Dual probe:Phased array transducer (G3S) for Deep scanning41 42.6Vscan Extend – configured with Dual probe:Linear array transducer (G8L) allowing shallow scanning39.1 42.3
Device labels and symbolsVscan Extend – User Manual 2-255721203-100 Rev. DDevice labels and symbolsVscan Extend Labels (Example) Figure 2-2. Vscan Extend rating labelNOTE: The label shown in Figure 2-2 is a sample. The label varies country to country based on country requirements.1. Rating label2. Inner label3. UDI label - contains UDI information4. Serial number label - contains device serial number
Safety2-26 Vscan Extend – User Manual5721203-100 Rev. DVscan Extend Labels (Example) (continued)Figure 2-3. Vscan Extend battery labelFigure 2-4. Vscan Extend AC/DC adapter labelFigure 2-5. Vscan Extend external battery charger label
Device labels and symbolsVscan Extend – User Manual 2-275721203-100 Rev. DVscan 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 IconsLabel Purpose LocationCE mark • Vscan Extend system• Vscan Extend External Battery chargerThis 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.• Vscan Extend system• Vscan Extend battery• Vscan Extend External battery chargerFollow instructions for use. Read and understand all instructions in the User's Manual before attempting to use the ultrasound unit.• Vscan Extend system• Vscan Extend External Battery chargerTÜV mark Vscan Extend systemPrescription device statement for the USA only:Caution: Federal law restricts this device to sale by or on the order of a physician.Vscan Extend systemType BF Applied Part symbol (see ‘Classifications’ on page i-5)Vscan Extend systemKeep dry Vscan Extend systemInput, use only Vscan Extend charger. Vscan Extend systemVscan Extend External Battery chargerRechargeable, use only Vscan Extend battery.Vscan Extend systemVscan Extend External Battery chargerInput to Vscan Extend battery Vscan Extend External Battery charger
Safety2-28 Vscan Extend – User Manual5721203-100 Rev. DNOTE: As a safety precaution, scanning is not possible when charging the battery.Manufacturer name and address • Vscan Extend system• Vscan Extend External Battery chargerManufacturing date (year-month) • Vscan Extend system• Vscan Extend External Battery chargerPart number • Vscan Extend system• Vscan Extend External Battery chargerSerial number • Vscan Extend system• Vscan Extend External Battery chargerUnique 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.Vscan Extend systemRefer label inside Vscan Extend systemAssembled in Romania (Romania is a country name)Identify the customs country of origin of the materials.Vscan Extend systemPush button (power switch) Vscan Extend systemTable 2-8: Label Icons (Continued)Label Purpose Location
Device labels and symbolsVscan Extend – User Manual 2-295721203-100 Rev. DExplanation of the Pollution control label for ChinaThe following product pollution control information is provided according to SJ/T11364-2014 Marking for Restriction of Hazardous Substances caused by electrical and electronic productsTable 2-9: Label for ChinaLabel DescriptionThis 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 substancesComponent NameHazardous Substances' NamePb Hg Cd Cr6+ PBB PBDEProbe & Cable X OOOOOMain unit OOOOOOO: 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.
Safety2-30 Vscan Extend – User Manual5721203-100 Rev. D
Vscan Extend – User Manual 3-15721203-100 Rev. DChapter 3Preparing Vscan Extend forUseContents:‘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
Preparing Vscan Extend for Use3-2 Vscan Extend – User Manual5721203-100 Rev. DPackage contentsVscan Extend package contentsMake sure all items listed below are included in the package.Figure 3-1. Vscan Extend package contents1. Vscan Extend softcase with device and probe2. USB cable3. Gel bottle location4. Region-specific plugs5. AC/DC adapter6. BatteryTable 3-1: Package content Item DescriptionVscan Extend Quick CardVscan Extend User ManualService contact information
Environmental requirementsVscan Extend – User Manual 3-35721203-100 Rev. DEnvironmental requirementsEnvironmental requirements for the deviceTransient operating conditionsNOTE: Permissible transient environmental operating conditions:• Temperature range of 0-40 degrees• Relative humidity range of 15 to 90% non-condensingNOTE: Avoid exposing the unit to saline moisture. In case of exposure 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 ready for 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 ready for use at 20 degrees ambient is approximately 1 minute.The Vscan Extend is transportable in a road ambulance or fixed /rotary wing aircraft.Table 3-2: Environmental requirementsDescription Operational Non operational Storage and transportTemperature 0 °C to + 40 °C - 40 °C to + 70 °C - 40 °C to + 70 °CHumidity 90%, non-condensing 15–90% 90%, non-condensingAir pressure 620 hPa to 1060 hPa 620 hPa to 1060 hPa 620 hPa to 1060 hPa
Preparing Vscan Extend for Use3-4 Vscan Extend – User Manual5721203-100 Rev. DSystem descriptionSystem overviewVscan Extend configured with a Sector probe for deep scanningFigure 3-2. Vscan Extend with a Sector probeNOTE: Green LED indicates Vscan Extend is fully charged and an amber LED indicates it is charging.1. Display2. Sector probe3. Serial port (For Service ONLY)4. Power button5. LED indicates charging status6. USB port and Power connector
System descriptionVscan Extend – User Manual 3-55721203-100 Rev. DVscan 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 probeNOTE: Green LED indicates Vscan Extend is fully charged and an amber LED indicates it is charging.1. Display2. Dual probe3. Serial port (For Service ONLY)4. Power button5. LED indicates charging status6. USB port and Power connector
Preparing Vscan Extend for Use3-6 Vscan Extend – User Manual5721203-100 Rev. DVscan Extend Dual ProbeFigure 3-4. The dual probe1. Phased array transducer (deep scanning)2. Linear array transducer (shallow scanning)
System descriptionVscan Extend – User Manual 3-75721203-100 Rev. DAccessories and ConfigurationsStandard and optional accessoriesTable 3-3: Standard accessoriesAccessory Figure1. Global AC adapter with interchangeable region-specific plugs2. One rechargeable battery3. USB cable4. MicroSD memory card (For service personnel only. Not for customer use.*)5. Soft case6. User Manual7. 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
Preparing Vscan Extend for Use3-8 Vscan Extend – User Manual5721203-100 Rev. D8. Gel (60g bottle)**Table 3-3: Standard accessoriesAccessory Figure* 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
System descriptionVscan Extend – User Manual 3-95721203-100 Rev. DStandard and optional accessories (continued)Table 3-4: Optional accessoriesAccessory Figure1. Additional Soft case2. Robust case to carry complete Vscan Extend set3. Robust case to carry only scanner, gel, and potential extra battery4. External Battery charger5. Additional Battery6. Additional AC adapter7. Hardcopy User manual
Preparing Vscan Extend for Use3-10 Vscan Extend – User Manual5721203-100 Rev. DConnectivity ConfigurationsVscan Extend is available in three different connectivity configurations:1. USB configuration2. Wi-Fi Access configuration3. DICOM configurationThe table below describes the standard and connectivity configurations.Table 3-5: ConfigurationsDescription USB configuration Wi-Fi Access configuration DICOM configurationGeneric image format (jpg, mp4) for data stored on device or exported to PCAAAImage transfer to PC via USB cable A A AManual labeling of exam data with patient IDAAAFIPS compliant data encryption A A AData backup capability on microSD card A A AWireless image transfer to shared network foldersAAEnterprise grade wireless encryption standards including EAP and WPA2 (PSK)AAMobile Device Management client supportAAAccess to GE marketplace to selectively download and install Vscan Extend apps Bladder Volume A A Lung Protocol A A Tricefy Uplink A AWireless reading DICOM Modality WorklistAWireless image export in DICOM format AAccess to reference materials on Vscan web portalAAA* The Vscan Extend app represents only the interface to the cloud-based case exchange solution which is separately provided by GE A: Available Blank cells indicates: Not Available
System descriptionVscan Extend – User Manual 3-115721203-100 Rev. DExternal 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 unit 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 compartmentThe table below lists the units or parts that can be replaced by the user (CRU - Customer Replacable units)Table 3-6: CRUDescription Part numberBattery 5693456AC/DC adapter 5693487Application Software SD Card5716858External Battery Charger 5716861
Preparing Vscan Extend for Use3-12 Vscan Extend – User Manual5721203-100 Rev. DDisplay screensFigure 3-6. Scanning screens (Black and white mode)NOTE: The screen graphics in this manual are only for illustrational purposes. Actual screen output or graphics may vary.Phased array transducer 1. Header• Menu icon• Patient information• Exam number• Battery level indicator• MI and TI values2. Depth scale3. Footer• Color icon• Gain• Depth• StoreLinear array transducer1. Header• Menu icon• Patient information• Exam number• Battery level indicator• MI and TI values2. Depth scale3. Footer• Color icon• Gain• Depth• Store
System descriptionVscan Extend – User Manual 3-135721203-100 Rev. DDisplay screens (continued) Figure 3-7. Scanning screens (Color mode)Phased array transducer 1. Header• Menu icon• Patient information• Exam number• Battery level indicator• MI and TI values2. Depth scale3. Footer• Color icon• Gain• Depth• Store4. Color bar5. Color ROI (Region of Interest)Linear array transducer1. Header• Menu icon• Patient information• Exam number• Battery level indicator• MI and TI values2. Depth scale3. Footer• Color icon• Gain• Depth• Store4. Color bar5. Color ROI (Region of Interest)
Preparing Vscan Extend for Use3-14 Vscan Extend – User Manual5721203-100 Rev. DDisplay screens (continued)Figure 3-8. Menu screen
Vscan Extend BatteryVscan Extend – User Manual 3-155721203-100 Rev. DVscan Extend BatteryBatteryThe 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 batteryBattery specificationTable 3-7: Battery specificationItems Unit Value DescriptionBasic Voltage mV 7400 MAXCurrent mA 1150 Avg 1C
Preparing Vscan Extend for Use3-16 Vscan Extend – User Manual5721203-100 Rev. DBattery (continued)Figure 3-10. Vscan Extend AC adapter Figure 3-11. Patient environmentWARNING 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.CAUTION The AC adapter must be kept outside the patient environment (refer to local regulation and EN 60601-1).1. Patient environmentWARNING Do NOT simultaneously touch the patient and the charger plug on the AC adapter.
Vscan Extend BatteryVscan Extend – User Manual 3-175721203-100 Rev. DPower plugs1. Select the country specific plug.Figure 3-12. Power plugs2. Insert the relevant plug into the adapter.Figure 3-13. Insert the plugVoltage requirementsThe AC/DC adapter will function on voltage from 100 to 240 VAC and 50/60 Hz.1. North America, Japan2. China3. Australia, New Zealand4. UK, Hong Kong, Singapore5. Continental Europe and Korea (for unearthed electrical outlet)CAUTION Only use mains power of 100 – 240 VAC. Voltage outside this range can cause a malfunction or destroy the AC/DC adapter.
Preparing Vscan Extend for Use3-18 Vscan Extend – User Manual5721203-100 Rev. DCharging the battery1. Insert the battery into the device.Figure 3-14. Insert the battery2. Plug the AC/DC adapter into the electrical outlet.Charging the battery using the optional External battery charger compartment1. Place the external battery charger on a flat surface.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 provided 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.
Vscan Extend BatteryVscan Extend – User Manual 3-195721203-100 Rev. DBattery level indicator The battery level indicator is displayed on the screen. The following icons are displayed.Table 3-8: Battery level indicatorIcon DescriptionBattery 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.
Preparing Vscan Extend for Use3-20 Vscan Extend – User Manual5721203-100 Rev. DInserting/removing the batteryTo insert the battery1. Insert the battery in the compartment until the lid clicks in place.Figure 3-15. Inserting batteryTo remove the battery1. Power off the Vscan Extend.2. Push the button on the battery compartment lid and lift the battery.Figure 3-16. Removing batteryCAUTION Do not attempt to remove the battery without powering off the Vscan Extend.
Vscan Extend BatteryVscan Extend – User Manual 3-215721203-100 Rev. DBattery specifications 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.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 requirements for the device’ on page 3-3).Table 3-9: Battery specificationItem SpecificationCharging time at 90% About 75 minutesCapacity About 1 hour while continuously scanningLifetime At least 300 charges
Preparing Vscan Extend for Use3-22 Vscan Extend – User Manual5721203-100 Rev. DInitial useFirst 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/offTo power on the Vscan ExtendPress 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 Extend1. Press the Power button.A pop-up displays prompting to Power off OR Restart.2. Select Power off.
Initial useVscan Extend – User Manual 3-235721203-100 Rev. DTo restart Vscan Extend1. Press and hold the Power button.2. Select Restart to restart the device.Standby ModeVscan Extend enters standby mode when the Power button is quickly pushed. In this mode, Vscan Extend will not have power to the probe or any display.ORVscan 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. Sleep ModeVscan 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.NOTE: When resuming the device from sleep mode, a new exam is created and the previous exam data is lost, if not previously saved. Startup procedureThe approximate time taken for the device from switching on until the device is ready for normal use is 40 seconds.
Preparing Vscan Extend for Use3-24 Vscan Extend – User Manual5721203-100 Rev. DVscan Extend activationActivationThere 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 page 4-12) to activate Vscan Extend.Activation using Wi-FiThe activation process includes steps to register the Vscan Extend device.NOTE: When Wi-Fi is enabled the device can be activated directly.
Initial useVscan Extend – User Manual 3-255721203-100 Rev. DSet Language, Date and Time1. 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. Figure 3-17. Select language4. Choose the desired language. The screen changes back to the Language screen.5. Press Next.
Preparing Vscan Extend for Use3-26 Vscan Extend – User Manual5721203-100 Rev. DSet 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 TimeChoose either the automatic date and time format which sets the date and time by synchronizing through the internet.ORSet the date and time manually.8. Press Next.
Initial useVscan Extend – User Manual 3-275721203-100 Rev. DConnecting Wi-FiNOTE: If Wi-Fi is not detected, configure Wi-Fi. See ‘Configuring Wi-Fi’ 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 settings2. 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.
Preparing Vscan Extend for Use3-28 Vscan Extend – User Manual5721203-100 Rev. DConnecting Wi-Fi (continued)1. Enter the authentication details to connect to the network.Figure 3-20. Authentication code2. 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.
Initial useVscan Extend – User Manual 3-295721203-100 Rev. DRegistrationRegistering the device creates a Vscan Extend account which enables access to the GE Marketplace and other features.First time registrants1. First time registrants, press Register to create an account.Enter the required details.Figure 3-21. Registration detailsNOTE: 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.Figure 3-22. Keyboard tipsHINTS Press the Arrow key twice to get the letters in all caps and press the number key to toggle between numbers and alphabet.
Preparing Vscan Extend for Use3-30 Vscan Extend – User Manual5721203-100 Rev. DFirst 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 option5. Vscan Extend has been activated. Press Start Using Device.Figure 3-24. Start using Vscan Extend
Initial useVscan Extend – User Manual 3-315721203-100 Rev. DRegistered usersNOTE: Ensure Vscan Extend is connected to a non-clinical Wi-Fi.1. Press Already Registered.2. Enter your email ID and password.Figure 3-25. Already RegisteredNOTE: 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.
Preparing Vscan Extend for Use3-32 Vscan Extend – User Manual5721203-100 Rev. DRegistered 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
Initial useVscan Extend – User Manual 3-335721203-100 Rev. DAlready registered users - Forgot password1. 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 password3. 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. Figure 3-28. Reset password and start using Vscan Extend
Preparing Vscan Extend for Use3-34 Vscan Extend – User Manual5721203-100 Rev. DNetwork access failed1. If you are unable to connect to a Wi-Fi network, press Retry and try to activate the device again.Figure 3-29. Retry2. 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.
Initial useVscan Extend – User Manual 3-355721203-100 Rev. DManual activationTo 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.NOTE: The PC should have internet access. If there is no internet 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 rear label of the system.3. User information as per the figure below.Figure 3-30. User Information4. Enter other necessary details.Figure 3-31. Opt-in checkboxFigure 3-32. Opt-in communication
Preparing Vscan Extend for Use3-36 Vscan Extend – User Manual5721203-100 Rev. DManual activation (continued)5. Press Submit to initiate registration.Figure 3-33. Submit6. The Activation key is generated. Store the key in a convenient location to enter into the device and for future reference.Figure 3-34. Activation key details
Initial useVscan Extend – User Manual 3-375721203-100 Rev. DActivation keyThe 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 key2. Press Activate.Figure 3-36. Start using the device3. Vscan Extend has been activated. Start using the device.HINTS Press the Backspace key if a mistake occurred while entering the activation key.
Preparing Vscan Extend for Use3-38 Vscan Extend – User Manual5721203-100 Rev. D
Vscan Extend – User Manual 4-15721203-100 Rev. DChapter 4Vscan Extend SettingsContents:‘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
Vscan Extend Settings4-2 Vscan Extend – User Manual5721203-100 Rev. DSettingsThe following settings and functions are available under the main Settings menu.Scan SettingsPress Menu -> Settings Figure 4-1. Settings• Brightness - adjusts the screen brightness of the deviceSwipe the brightness level indicator to the left to decrease the brightness and swipe to the right to increase the brightness.
SettingsVscan Extend – User Manual 4-35721203-100 Rev. DScan Settings (continued)Auto Freeze (Probe) - set the auto freeze time.1. Press Auto Freeze (Probe)2. Choose the desired value3. Press OK to set the valueVideo Duration - set duration of the captured Cine loops.1. Press Video Duration2. Choose the desired value3. Press OK to set the valueUnit of Measurement - set unit of measurement1. Press Unit of Measurement2. Choose the desired unit3. Press OK to set the valueSet current preset as default1. Press Set Current Preset as Default2. Press Yes to set the displayed preset as default.Server SettingsAllows to configure the DICOM servers.Figure 4-2. Server settingsWorklist Server - gets patient and intended study informationImage Server - remote store location for media (video/images)DICOM Encoding - Choose the desired encoding type and press OK.
Vscan Extend Settings4-4 Vscan Extend – User Manual5721203-100 Rev. DServer Settings (continued)To configure the Worklist server:1. Press Menu -> Settings Figure 4-3. Settings2. Scroll down to Server Settings. Press Worklist Server.Figure 4-4. Worklist serverHINTS Press the title bar (the entire top section on the screen) or swipe left most side of the screen to access the Menu.
SettingsVscan Extend – User Manual 4-55721203-100 Rev. DConfigure Worklist ServerConnect 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.Figure 4-5. Configure Worklist ServerNOTE: Swipe upwards to get the full screen and enter all details. Contact the hospital IT administrator for details.
Vscan Extend Settings4-6 Vscan Extend – User Manual5721203-100 Rev. DConfigure Worklist Server (continued)NOTE: By default, DICOM is listed while configuring the Worklist Server.Figure 4-6. DICOM listed2. 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
SettingsVscan Extend – User Manual 4-75721203-100 Rev. DConfigure Worklist Server (continued)“Verify OK” pop-up displays if the communication with the Worklist Server is ok.If communication fails:• check the server settings and make necessary corrections.• Vscan Extend and the DICOM image server are not connected to the same network. Check network settings for all components.5. Press and hold the selected Worklist entry to add to the favorites list. By default, the first added Worklist server is set as the favorite. To remove a Worklist server from the favorites list, press and hold on the server name. If you wish to change it, press and hold to remove the current favorite and add the preferred server.Figure 4-8. Add to favoritesNOTE: If only one DICOM MWL server is configured, it is automatically set as the favorite. NOTE: The scheduled exam list will automatically be pulled from the favorite server.
Vscan Extend Settings4-8 Vscan Extend – User Manual5721203-100 Rev. DConfigure Worklist Server (continued)6. To add another Worklist server, press Add (+).Figure 4-9. Add another Worklist server7. To delete the Worklist Server, press the Delete icon.Figure 4-10. Delete Worklist
SettingsVscan Extend – User Manual 4-95721203-100 Rev. DConfigure Image Server1. Press Menu -> Settings Figure 4-11. Menu2. Scroll down to Server Settings. Press Image Server.Figure 4-12. Image Server
Vscan Extend Settings4-10 Vscan Extend – User Manual5721203-100 Rev. DConfigure Image Server (continued)3. Enter your Image server’s IP address, port number, and Remote AE Title.Figure 4-13. Configure Image ServerNOTE: Enter any unique name for Calling AE Title (e.g. Nixon Building Image Archive). Contact the hospital IT administrator for details.4. Press Add Server.
SettingsVscan Extend – User Manual 4-115721203-100 Rev. DConfigure Image Server (continued)5. Press Verify to verify that the communication with the Image Server is ok.Figure 4-14. Verify Image Server“Verify OK” pop-up displays if the communication with the Image Server is ok.If communication fails:• Check the server settings and make necessary corrections.• Vscan Extend and the DICOM image server are not connected to the same network. Check network settings for all components.
Vscan Extend Settings4-12 Vscan Extend – User Manual5721203-100 Rev. DConfigure Image Server (continued)6. Press and hold the Image Server to add the selected Image Server to favorites.Figure 4-15. Add to favoritesNOTE: When you have added more than one image server, you can set one as a favorite. Once an image server is set as a favorite, saved images are automatically exported once patient information is added or edited for any exam.DiagnosticsFigure 4-16. Diagnostics• System Diagnostics - Performs main board or hardware diagnostics• Display Test - Perform this test if there is a problem with the display. Use a swiping motion to navigate through all the screens. If an issue persists, contact GE Service.
SettingsVscan Extend – User Manual 4-135721203-100 Rev. DSystem SettingsFigure 4-17. System Settings• Admin Settings - Change date, time and configure Wi-Fi• GE Marketplace - Select an app• Facility Name - Set Facility Name• Session Duration - When the device is idle, data access is active for the duration set. The default duration is 1 hour. The following values are available to set the duration: • 5 min • 15 min• 1 hr• 5 hrs• 1 day• neverWARNING When the device is idle for the duration set, it is the reponsibility of the user to ensure that the device is not used by unauthorized persons as it may lead to data loss.
Vscan Extend Settings4-14 Vscan Extend – User Manual5721203-100 Rev. DSystem Settings (continued)• Configuration - Choose the desired option through an option key, either manually (enter the serial number of the device in the portal on a PC to obtain the option key) or (if Wi-Fi is connected, check for updates)Figure 4-18. ConfigurationPress View Modules to obtain the list of enabled modules.Figure 4-19. Enabled modules• My Account - Set User account• About - Provides device information
SettingsVscan Extend – User Manual 4-155721203-100 Rev. DAdministrator AccessFor security purposes, the user has to create an admin PIN. This PIN provides access to the Admin settings. 1. Create a new PIN (four digit number e.g. 1234) for security purpose.Figure 4-20. Create admin PIN2. Enter the new PIN again for confirmation.Figure 4-21. Confirm new PINNOTE: The PIN is critical to accessing system data. Avoid sharing this PIN with non-administrators and take precautions to not lose this PIN.
Vscan Extend Settings4-16 Vscan Extend – User Manual5721203-100 Rev. DAdministrator Access (continued)The new PIN provides access to advanced settings.Figure 4-22. Advanced Settings
SettingsVscan Extend – User Manual 4-175721203-100 Rev. DStorage AccessA device PIN has to be created for security purposes to access or store images/ videos. This PIN is created prior to the first use or after the system has been reset. Once the PIN is set, the user is prompted for the PIN every time the device is powered ON or after the session duration time has expired.1. Create a new PIN for data storage and access, for e.g., 1234.Figure 4-23. User PIN2. Confirm the new PIN for security purpose. Confirmation is only required after PIN creation.Figure 4-24. Confirm PIN
Vscan Extend Settings4-18 Vscan Extend – User Manual5721203-100 Rev. DStorage Access (continued)A PIN security note also desplays to the user:This PIN is critical for accessing system data. It is required to access and store system data. Please remember a wrong / incorrect PIN entry can lead to loss of system data. Avoid sharing the PIN to unauthorized users for data protection.Figure 4-25. Remember PINThe new PIN provides access to data storage and retrieval during normal use of the Vscan Extend.Incorrect PINThe Vscan Extend prompts to enter the PIN after power ON or reboot. User can skip entering the PIN and continue scanning by pressing the scan symbol at the bottom of the screen, see Figure 4-26 on page 4-19. In this case, scanning is allowed but images/videos cannot be stored or accessed.
SettingsVscan Extend – User Manual 4-195721203-100 Rev. DIncorrect PIN (continued)1. A pop-up message displays when an incorrect PIN is entered.Figure 4-26. Wrong PIN2. After 5 wrong attempts, the Vscan Extend displays a pop-up message to “Backup” data on a microSD card before the next login. See ‘Backup’ on page 5-42 for more information.Figure 4-27. Backup data
Vscan Extend Settings4-20 Vscan Extend – User Manual5721203-100 Rev. DIncorrect PIN (continued)3. If backup is not performed after 5 attempts of wrong PIN entry and once again a wrong PIN is entered, a pop-up message displays for every incorrect PIN entry thereafter. For e.g., 4, 3, 2, 1 attempt(s) left.Figure 4-28. Remaining attemptsNOTE: It is highly recommended to back up data on a microSD card before the last attempt.After the 10th attempt, the system resets and returns to the initial screen where a new pin should be entered see Figure 4-23 on page 4-17.
SettingsVscan Extend – User Manual 4-215721203-100 Rev. DWi-FiWi-Fi is a local area wireless computer networking technology that allows electronic devices to network.For Wi-Fi to work on the Vscan Extend:1. Activate Wi-Fi on the device.2. Connect to a specific network.Activating Wi-FiTo activate Wi-Fi on the Vscan Extend:1. Press Menu -> Settings -> Admin Settings. Figure 4-29. Admin Settings2. Enter the Admin PIN to access advanced settings (settings of the operating system). See ‘Administrator Access’ on page 4-15 for more information.
Vscan Extend Settings4-22 Vscan Extend – User Manual5721203-100 Rev. DActivating Wi-Fi (continued)3. Press Settings on the Dashboard.Figure 4-30. Advanced Settings
SettingsVscan Extend – User Manual 4-235721203-100 Rev. DConfiguring Wi-Fi1. Press the ON/OFF button on the right to turn ON Wi-Fi.2. Press Wi-Fi.Figure 4-31. MenuChoose the network if you know the credentials or contact your system administrationProcedure to check the MAC AddressNOTE: If the Wi-Fi network has been configured with the MAC address, press MAC Address on the Advanced Settings screen.Figure 4-32. Mac address
Vscan Extend Settings4-24 Vscan Extend – User Manual5721203-100 Rev. DDeleting Wi-Fi networks1. Press Settings from the Dashboard.2. Press Wi-Fi.3. Select the network to be deleted. A pop-up displays prompting you to forget or modify the network.4. Press Forget network.MDM Installation Procedures (Optional)NOTE: Network administrators use MDM (Mobile Device Management) to manage devices on the network.1. Press Google Play Store on the Dashboard screen. See ‘Configuring Wi-Fi’ on page 4-23 for more information.NOTE: You will be prompted to create a new account or add an existing one. Choose Add new and follow the instructions. Google Play Store is now available on the dashboard.Figure 4-33. Google Play Store
SettingsVscan Extend – User Manual 4-255721203-100 Rev. DMDM Installation Procedures (Optional) (continued)2. Install the correct MDM agent from Google Play (Airwatch, Mobile Iron).Figure 4-34. MDM3. View the MDM service client with the help of your IT department.Figure 4-35. MDM installed
Vscan Extend Settings4-26 Vscan Extend – User Manual5721203-100 Rev. DMDM Installation Procedures (Optional) (continued)4. Press the Back arrow to go to Dashboard.5. Press Kiosk Settings.NOTE: Kiosk Settings provides access to advanced settings.Figure 4-36. Kiosk Settings6. Press Admin Console App Chooser.Figure 4-37. Admin Console App Chooser
SettingsVscan Extend – User Manual 4-275721203-100 Rev. DMDM Installation Procedures (Optional) (continued)7. Select the MDM Agent and press Update.Figure 4-38. Select MDM AgentFigure 4-39. UpdateThe MDM agent is listed in the Dashboard.
Vscan Extend Settings4-28 Vscan Extend – User Manual5721203-100 Rev. DCertificate AuthorityTrusted certificates are typically used to make secure connections to a server over the Internet.Use client and Certificate Authority (CA) digital certificates to enable the device to access VPN or secured Wi-Fi networks, and also to provide authentication to online secure servers.You can get a certificate from your system administrator or download it from sites that require authentication.1. Press the ... icon at the bottom of the Wi-Fi Screen.Certificate delivery is completed using an over-the-air enrollment method, where the certificate is delivered directly to your Vscan Extend via a browser link.NOTE: Contact your system administrator to download certificate on device.Figure 4-40. Advanced menu
SettingsVscan Extend – User Manual 4-295721203-100 Rev. DCertificate Authority (continued)2. Press Install certificate.Figure 4-41. Install certificateTo complete the install, you need to add the certificate to your device's security credentials.• Press Security on the Settings screen. • Select Install from phone storage to get the certificate file from the downloads folder of your device.
Vscan Extend Settings4-30 Vscan Extend – User Manual5721203-100 Rev. DCertificate Authority (continued)• Download the certificate from Downloads.• Now that the certificate has been added to your device's credentials, you can set the certificate name and choose Wi-Fi depending on the certificate's purpose.Figure 4-42. Download CertificateThe certificate is successfully downloaded onto your Vscan Extend. You can now choose it while connecting to a certificate based Wi-Fi authentication.
SettingsVscan Extend – User Manual 4-315721203-100 Rev. DGE MarketplaceRegistered users of Vscan Extend (with Wi-Fi Access or DICOM configuration) have access to GE Marketplace to install applications like Bladder Volume, Lung Protocol, Case Exchange and Tricefy on the Vscan Extend. NOTE: GE Marketplace registration is separate from device registration when activating the Vscan Extend.NOTE: If the email used during registration is not confirmed, you need to confirm the email to access GE Marketplace.Figure 4-43. Confirm emailA confirmation is sent to the email address to confirm your email and set your password.
Vscan Extend Settings4-32 Vscan Extend – User Manual5721203-100 Rev. DInstalling Vscan Apps1. Press GE Marketplace on the Settings screen.Figure 4-44. GE MarketplaceFigure 4-45. Connecting to GE Marketplace
SettingsVscan Extend – User Manual 4-335721203-100 Rev. DInstalling Vscan Apps (continued)2. List of available Vscan apps are displayed.Figure 4-46. List of Vscan Apps3. Select the App (for example, Bladder Volume). Press Install.Figure 4-47. Install app4. The App gets downloaded and prompts you to install. Press Install.
Vscan Extend Settings4-34 Vscan Extend – User Manual5721203-100 Rev. DUpdating the MarketplaceOn the Apps screen list, updates are displayed when available. Select the App you wish to update and press Update on the App (for example, Lung Protocol).NOTE: If no apps have been installed, a message displays “You have no apps installed yet.”NOTE: While the apps are updating, there is no loss of data. The updated app requires no new permission.Uninstalling Apps1. Press Menu -> Settings -> GE Marketplace. Press the App to uninstall. For example, Bladder volume.2. Press Uninstall.Figure 4-48. Uninstall
SettingsVscan Extend – User Manual 4-355721203-100 Rev. DScenarios while trying to access GE MarketplaceEmail address not validUser will not receive a confirmation email if a valid email address is not entered to register the Vscan Extend. The following message displays:The email address is not confirmed in our system. Request a confirmation to be resent.OREnter a password matching the email to confirm your device.Figure 4-49. Resend confirmation emailEnter a valid email address. A confirmation email is sent. On your PC, set the password.Figure 4-50. Set password
Vscan Extend Settings4-36 Vscan Extend – User Manual5721203-100 Rev. DEmail address not confirmedUser has already a registered email address, but the Vscan Extend is yet to be confirmed. Type the registered email address and password. Press Login. Figure 4-51. Request for confirmation emailA message displays: This Vscan Extend device has been registered to your account.The user account details page displays.Figure 4-52. Account detailsPress the Back arrow and press GE Marketplace.
Vscan Extend – User Manual 5-15721203-100 Rev. DChapter 5Using Vscan ExtendContents:‘Scanning’ on page 5-2‘Measurements’ on page 5-24‘Review and recall of stored data’ on page 5-26‘Using Vscan Extend Apps’ on page 5-47
Using Vscan Extend5-2 Vscan Extend – User Manual5721203-100 Rev. DScanningGeneral scanning recommendationsBefore each use:Inspect the transducer (see ‘Before each use’ on page 6-3).After Each Use• Inspect the transducer (see ‘Cleaning the probe’ on page 6-6)• Clean the transducer (see ‘Disinfecting the probe’ on page 6-9).• If required, clean the device and the display (see ‘Disinfecting the device’ on page 6-7).• If required, disinfect the transducer (see ‘Disinfecting the probe’ on page 6-9).Ensure that the main unit and the transducer are properly cleaned after each use and before storing in the case.WARNING If any damage is found on the transducer or its cable, DO NOT use the Vscan Extend. Contact GE service.
ScanningVscan Extend – User Manual 5-35721203-100 Rev. DUse of gelIn order to ensure optimal transmission of energy between the patient and the transducer, a conductive gel must be applied on the transducer lens.The following gels have been tested to be compatible with the Vscan Extend.For more information regarding probe care, refer to the website: http://www3.gehealthcare.com/en/Products/Categories/Ultrasound/Ultrasound_Probes. Select Dual Probe on Vscan and G3S Probe on Vscan from the Transducer list to get the details.CAUTION If the gel comes in contact with the eye, consult the gel manufacturer's instructions.Table 5-1: Compatible Gels Aquasonics 100 Parker Laboratory Inc.Clear Image Sonotech Inc.Scan Parker Laboratory Inc.Sonogel Sonogel Vertriebs GmbHWavelength National Therapy Products Inc.
Using Vscan Extend5-4 Vscan Extend – User Manual5721203-100 Rev. DOther recommendationsLike most high frequency computing devices, the electronic components of Vscan Extend will generate some heat while operating normally and as intended. Vscan Extend is equipped with safety mechanisms which will automatically reduce computing speed (frame rate), and ultimately shut down the device, before any risk of overheating occurs. Vscan Extend is verified to comply with harmonized safety standards (see ‘Conformance Standards’ on page i-3) under any operating condition described in this user manual (see ‘Environmental requirements for the device’ on page 3-3). To help keeping the Vscan Extend operating temperature at an optimal functional level, and to ensure longer scanning time with maximum frame rate, it is recommended to hold the Vscan Extend so that there is good contact between the device and the hand.CAUTION For patient and personnel safety, be aware of biological hazards. To avoid the risk of disease transmission:• Use protective barriers (gloves and transducer sheaths) whenever possible.• Follow all infection control policies established by your office, department or institution as they apply to personnel and equipment.
ScanningVscan Extend – User Manual 5-55721203-100 Rev. DProbe orientationThe sector probe is provided with an orientation mark. This mark is used to identify the end of the probe corresponding to the side of the image having the orientation V mark on the scanning screen.Figure 5-1. Sector probe orientationThe dual probe is provided with an orientation mark and a green LED light. This mark and the LED light are identifying the orientation of the probe using the fixed symbol displayed on the screen. In the case of the dual probe, the LED light is also indicating which probe head is active.Figure 5-2. Dual probe: Orientation mark, phased array active1. Orientation marking on probe2. Orientation marking on screen1. Orientation marking on probe2. Green LED light3. Orientation marking on screen
Using Vscan Extend5-6 Vscan Extend – User Manual5721203-100 Rev. DProbe orientation (continued)Figure 5-3. Dual probe: Orientation mark, linear array active1. Orientation marking on probe2. Green LED light3. Orientation marking on screen
ScanningVscan Extend – User Manual 5-75721203-100 Rev. DPatient examinationCreating new examA new exam can be created in two ways:1. The Vscan Extend is powered on and it goes to the scanning mode.2. Create New Exam from the Menu screen.• Press Menu.• Press New Exam.NOTE: A new exam gets created when Vscan Extend enters Standby mode and also when Vscan Extend is disconnected from a PC.NOTE: A new exam will not get saved only with patient details. The exam will get saved when an image or video is saved for that exam. NOTE: It is recommended to enter patient information using alphanumeric characters.
Using Vscan Extend5-8 Vscan Extend – User Manual5721203-100 Rev. DSaving a new examWhen an image or video is stored, the exam is automatically saved.NOTE: Current exam ends only when a new exam is created.Editing patient information for an examPatient information can be entered in two ways:• Edit Patient on the Menu screen• DICOM - Retrieve patient information from DICOM modality worklist1. Press Menu -> Edit Patient.Figure 5-4. Edit patient details
ScanningVscan Extend – User Manual 5-95721203-100 Rev. DEditing patient information for an exam (continued)2. Enter patient details and press Save.Figure 5-5. Save patient details3. Retrieve patient information from DICOM modality worklist broker. See ‘DICOM Modality Worklist: Retrieve patient information from DICOM Modality Worklist broker’ on page 5-37 for more information. 4. Retrieve the patient information from the DICOM modality worklist broker. Press Save.5. Patient information also gets saved when the patient is associated with an exam with images.
Using Vscan Extend5-10 Vscan Extend – User Manual5721203-100 Rev. DSearch PatientA patient can be searched from either My Worklist or by entering the patient name or ID.1. Press Menu -> Edit Patient.Figure 5-6. Edit patient2. Press Search icon.Figure 5-7. Search icon
ScanningVscan Extend – User Manual 5-115721203-100 Rev. DSearch Patient (continued)3. Type the patient name or patient ID in the search fieldNOTE: Press the Other tab to type the patient name or ID in the search field.4. Find patient information on My Worklist (Optional)If the device is configured for DICOM (depending on the configuration purchased), patient information can be pulled from My Worklist. Perform the exam for this patient and press Save.Figure 5-8. Search patientNOTE: Patient information can be modified, if needed, using the Edit Patient feature.
Using Vscan Extend5-12 Vscan Extend – User Manual5721203-100 Rev. DProbe and PresetsThe following table indicates the imaging modes supported by the probes.To ensure optimal image quality, the Vscan Extend has predefined scanning settings optimized for different applications (e.g. Cardiac, Abdominal). Refer to the tables below to select the correct probe and preset combination before scanning.Table 5-2: Supported imaging modesProbe Black and white imaging Color flowG3S Phased array X (Harmonic) XDual probe (G3S phased array and G8L linear array)X (Harmonic for G3S phased array)XTable 5-3: Phased array transducer in G3S and Dual Probe (deep scanning) presetsPhased array transducer in G3S and Dual Probe(deep scanning) Preset Optimized forCardiac • Heart• Aorta• LungAbdominal • Liver• Kidney• Gall bladder• Spleen• Urology• Selective peripheral vascularObstetrics OB/GynAdult Cephalic Various cephalic structuresAorta Abdominal Aorta
ScanningVscan Extend – User Manual 5-135721203-100 Rev. DProbe and Presets (continued)NOTE: Vscan Extend with Dual probe (shallow and deep) can be used for procedural guidance.Table 5-4: Linear transducer in Dual Probe (shallow scanning) presets Linear transducer in Dual Probe(shallow scanning) Preset Optimized forVascular • Veins• ArteriesSoft tissue • Small organs• Pediatric (recommended minimum weight: 4kg)• Musculoskeletal - including Long bone, Hip, Knee, Shoulder and ElbowLung • Thoracic/Pleural motion• Fluid detectionAdult Cephalic Various cephalic structuresOphthalmic* Ophthalmic* Ophthalmic is available as an option for certain countries but is NOT available in the USA, China and Japan.
Using Vscan Extend5-14 Vscan Extend – User Manual5721203-100 Rev. DTo change the preset and probe1. Press Menu.2. Press the ... on the Preset tab.Figure 5-9. Menu page3. The presets for the available probe(s) are displayed. The preset automatically selected activates the probe for that preset.Select the desired probe/preset.Figure 5-10. Change Preset
ScanningVscan Extend – User Manual 5-155721203-100 Rev. DCreating preset favoritesUp to three presets can be saved as favorites and are available for quick access on the Menu page.To save favorites:1. Press Menu.2. Press the ... on the Preset tab.Figure 5-11. Menu page3. Press and hold the preset icon to select the desired favorite. The icon changes to blue to indicate the saved favorite.Figure 5-12. Presets favorites1. Probe/Preset Availability2. Preset Favorites (blue icon)
Using Vscan Extend5-16 Vscan Extend – User Manual5721203-100 Rev. DCreating preset favorites (continued)The Menu page displays the selected favorites.Figure 5-13. Menu pageNOTE: Only three presets can be selected as favorites at one time. Deselect a current favorite in order to add another preset as a favorite.To deselect a favorite, press and hold the preset icon. The color of the icon changes to gray (Figure 5-11).
ScanningVscan Extend – User Manual 5-175721203-100 Rev. DBlack and white imagingBlack and white imaging is intended to provide two-dimensional images and measurement capabilities concerning the anatomical structure of soft tissue.Black and white imaging is the default scanning mode.Figure 5-14. Black and white scan screenNOTE: As a safety precaution, scanning is not possible when charging the battery.
Using Vscan Extend5-18 Vscan Extend – User Manual5721203-100 Rev. DBlack and white imaging (continued)Black and white imaging adjustmentsThe following adjustments can be done to further improve the image quality:1. Gain - Black and white gain increases or decreases the amount of echo information displayed in an image. It may have the effect of brightening or darkening the image if sufficient echo information is generated.• Press the Gain icon.The gain slider disappears after a few seconds. Press Gain again to activate the slider. • Use the gain slider to increase or decrease gain.• Press the Gain icon again to hide the control.Figure 5-15. Gain
ScanningVscan Extend – User Manual 5-195721203-100 Rev. DBlack and white imaging adjustments (continued)• Depth adjusts the field of view. It increases the field of view to look at larger or deeper structures; it decreases the field of view to look at structures near the skin line.• Press the Depth icon.• Use the depth slider to increase or decrease depth.The depth slider disappears after a few seconds. Press the Depth icon again to activate the control. • Press the Depth icon again to hide the depth control, if needed.Figure 5-16. Depth
Using Vscan Extend5-20 Vscan Extend – User Manual5721203-100 Rev. DColor imagingColor imaging is intended to add color coded qualitative information concerning the relative velocity and direction of fluid motion within the black and white image.1. Press the Color icon.Figure 5-17. Color scanA color flow area displays on top of the black and white image.2. Press and hold the color region of interest. The region of interest changes to yellow, indicating it is ready to be moved within the scan area. Drag the region of interest to the desired area of interest.
ScanningVscan Extend – User Manual 5-215721203-100 Rev. DColor imaging (continued)3. Press Gain to access the color gain control.Figure 5-18. Color gainColor gain amplifies the overall strength of echoes processed in the color area.
Using Vscan Extend5-22 Vscan Extend – User Manual5721203-100 Rev. DColor imaging Scanning AdjustmentsColor AliasingIf the blood flow velocity exceeds the maximum velocity range the system can cover, based on the sampling rate used, aliasing occurs.Aliasing appears as a shift in color from the color representing positive velocity to color representing negative velocity or visa versa.The maximum velocity is displayed on top of the color bar.Color steerSlant the ROI (Region of Interest) of the Color Flow linear image left or right to get more information without moving the probe. Press and hold the color region of interest. The region of interest changes to yellow, indicating it is ready to be steered in a different direction. Drag the region of interest to the left or right depending on the desired angle.NOTE: Angle Steer applies only to the linear functionality of the Dual Probe.Figure 5-19. Color steer
ScanningVscan Extend – User Manual 5-235721203-100 Rev. DAuto freezeIf Vscan Extend is idle for a period of time, the device enters freeze mode to minimize risk of overheating and battery drainage. Press the display to unfreeze the image and continue scanning. See ‘Scan Settings’ on page 4-2 for more information.AutoCycleVscan Extend does not include an ECG interface as often found on larger ultrasound systems intended for cardiovascular applications. The AutoCycle feature detects a complete cardiac cycle by analyzing the cyclicity of the ultrasound intensity data. The resulting time-stamps are used for storing and playing cineloops smoothly. The AutoCycle feature should typically detect heart rates in the range 46–100 beats per minute. If the detected heart cycle is outside this range, or if the cyclicity quality is too poor, a default 2 sec loop will be used instead. The detected start and stop times for the AutoCycle are not necessarily in phase with the QRS complex. Since adequate cyclicity can only be expected in cardiac applications, all other applications will use the default config settings.Use of sterile sheathIt is recommended to use a sterile sheath around the probe and main unit if Vscan Extend is used as an aid to needle guidance or in any clinical situation where contamination could be a concern.
Using Vscan Extend5-24 Vscan Extend – User Manual5721203-100 Rev. DMeasurementsTaking measurementsVscan Extend enables distance measurement on frozen images in both black and white and color imaging. Up to eight measurements can be performed on an image. Measurements can be done during image review or on recalled stored images.To perform a measurement:1. On a frozen image, press Measure.The measurement calipers displays.2. Drag to position the calipers to obtain the desired measurement.3. To store the image with a measurement, press Store.Figure 5-20. Measurement
MeasurementsVscan Extend – User Manual 5-255721203-100 Rev. DTaking measurements (continued)4. Press Add New to make additional measurements on the displayed image. Up to 8 measurements can be made on a single image.Figure 5-21. Add new measurement5. Press Delete to delete a single measurement.
Using Vscan Extend5-26 Vscan Extend – User Manual5721203-100 Rev. DReview and recall of stored dataBackups RecommendedDuring live scanning, acquired images or videos are stored in the internal memory (image buffer). When the internal memory reaches 45% to 50% of its capacity, it is recommended to perform backup. To prevent loss of any images and videos, previously acquired images and videos must be stored to the microSD card. See ‘Backup’ on page 5-42 for more information.NOTE: The number of images and videos that can be stored depends on the internal memory of the device.NOTE: Backup data at regular intervals. If backup is not performed, the internal memory data can be lost and cannot be retrieved.Reviewing and recalling images or videos from an exam list1. Press Menu.2. Press Exams.A list of exams, with stored images and videos, display.3. Press on the desired patient and then press the image or video to get the full screen view.
Review and recall of stored dataVscan Extend – User Manual 5-275721203-100 Rev. DReviewing and recalling images or videos from an exam list (continued)Figure 5-22. View stored images and videosNOTE: Press on the image in the Exams screen. Use the right/left arrow to naviagte through the images/videos.
Using Vscan Extend5-28 Vscan Extend – User Manual5721203-100 Rev. DDeletion of dataTo delete a fileYou can delete images or videos individually or from an exam list.Deleting individual images or videos1. Press Menu.2. Press Exams.3. Select the Exam from which images or videos are to be deleted.4. Press Delete.5. Select the images or videos to be deleted.Figure 5-23. Images to be deleted6. Press Delete to delete the images.OR7. Press Cancel to cancel deletion.Figure 5-24. Delete or cancel
Review and recall of stored dataVscan Extend – User Manual 5-295721203-100 Rev. DDelete images from an exam list 1. Press Menu.2. Press Exams.3. Select the exam from the list.Figure 5-25. Images to be deleted4. Press Delete to delete the images.OR5. Press Cancel to cancel deletion.
Using Vscan Extend5-30 Vscan Extend – User Manual5721203-100 Rev. DData ExportData can be exported to a PC (‘USB Export’ on page 5-31), shared to a PC, exported to a DICOM server (‘DICOM Store: exporting DICOM images from Vscan Extend to DICOM image server’ on page 5-39), through Windows Share (‘Windows Share’ on page 5-32) or to GE’s separate cloud-based case exchange solution, if available on the device purchased.NOTE: GE’s separate cloud-based case exchange solution is available in the U.S. and UK only.Audit LogsThe Vscan Extend has audit logs of various types of events and activities.The audit logs captured in the microSD card can be exported to a PC. A report can be generated using these audit logs.The audit logs capture the following information:1. Device Start/Shut-down time2. Incorrect password attempts3. Additions and modifications to system configuration, including:• DICOM connection• Windows Share connection• Wi-Fi connection and security details (SSID, Network disconnect/connect timings)• Application software install/uninstall/upgrade• Registration of partnering apps4. Events related to Patient Data, including the following details:• Date/Time of data access• Type of action (addition, deletion, modification, reviewed)NOTE: Audit logs do not show the transfer of data to the PC.• Applications used (Bladder Volume, Lung Protocol, etc.)5. Data Export• Date/Time of data export, including end point and Wi-Fi SSID information• Data Backup/Restore details6. Invalid Device PIN attempt7. Kiosk admin mode login success and failure
Review and recall of stored dataVscan Extend – User Manual 5-315721203-100 Rev. DUSB ExportPatient images and videos can be transferred from Vscan Extend to a Personal Computer (PC) using a USB cable.The images or videos have the following details:• Color ROI• Depth marker• Probe indicator• Exam IDExport filesJPG and MPEG files, stored on the device internal memory, can be exported to a PC with a USB cable. The folder and file names start with the device ID (serial number), then exam ID and NNNNN. The folder structure looks like:....\Archive\EEEEEEE-XXXXXXX\EEEEEE-NNNNN-XXXXXXX.mpg....\Archive\EEEEEEE-XXXXXXX\EEEEEE-NNNNN-XXXXXXX.jpgwhereEEEEEEE is the device ID.XXXXXX is the exam ID.NNNNN is the file number in the folder.The files, file names, and folder names are non-patient identifiable.Import dataThe files exported to the PC can be copied back to a specific folder to the device with the USB cable (...\Import)
Using Vscan Extend5-32 Vscan Extend – User Manual5721203-100 Rev. DWindows ShareWindows share allows the system to send ultrasound images to a PC.1. Press Windows share from the list. Enter the required details - Domain name, IP address, User name and Password.Figure 5-26. Windows share2. Press Add server.NOTE: All the required fields need to be entered.3. Press Verify.A Verify OK message displays.4. Create a shared folder on the PC and provide the credentials and domain name.5. Provide access to users who need access to the shared folder.NOTE: Windows Share can also be added as a favorite and can be deleted as a favorite.NOTE: Share option is enabled only when any one of the fields in the patient details page is entered. Only images and videos are exported to the PC with the patient information anonymized.
Review and recall of stored dataVscan Extend – User Manual 5-335721203-100 Rev. DShare images1. Press Menu on the scan screen.2. Press Exams to be exported.3. Press Upload Selected.4. Select the created Windows Share destination.The exported folder is as as shown in the Figure 5-27 below.Figure 5-27. Exported image folderFigure 5-28. Images inside the exam folder
Using Vscan Extend5-34 Vscan Extend – User Manual5721203-100 Rev. DShare images (continued)5. If the exported image does not get transferred to the PC or if the transfer fails, a red icon appears next to the image.Figure 5-29. Transfer failed
Review and recall of stored dataVscan Extend – User Manual 5-355721203-100 Rev. DDevice StatusTo monitor/control DICOM and Windows share jobs, press Settings -> Device Status. The exam screen displays the job status, which range from:• in progress• success• failed• not startedFigure 5-30. Device Status
Using Vscan Extend5-36 Vscan Extend – User Manual5721203-100 Rev. DDICOMNOTE: This feature is available with the DICOM configuration.OverviewVscan Extend supports the following DICOM functionality:• Verify. See ‘Configure Worklist Server’ on page 4-5 for more information.• Modality Worklist• StoreDICOM users can use:1. DICOM Modality Worklist: Retrieve patient information from DICOM modality worklist broker2. Add patient identifying information to exam.• manually• selecting from modality worklist 3. DICOM Store: Export DICOM images from Vscan Extend to the DICOM image server.DICOM modality worklist serverTo configure the DICOM modality worklist server, See ‘Configure Worklist Server’ on page 4-5 for more information.
Review and recall of stored dataVscan Extend – User Manual 5-375721203-100 Rev. DDICOM Modality Worklist: Retrieve patient information from DICOM Modality Worklist brokerVscan Extend can download and refresh a DICOM modality worklist. An exam can be linked to an existing patient pulled from the worklist, prior to exporting to the DICOM image server.NOTE: It is not necessary to refresh the modality worklist for each exam.NOTE: When data is accessed for the first time, the device prompts for a ‘PIN’; enter the pin for security purposes.1. Press Menu - > Worklist.Figure 5-31. Worklist
Using Vscan Extend5-38 Vscan Extend – User Manual5721203-100 Rev. DDICOM Modality Worklist: Retrieve patient information from DICOM Modality Worklist broker (continued)2. Press Refresh to download Worklist entries.Figure 5-32. Refresh WorklistNOTE: It is not be possible to change the following DICOM attributes received from worklist: Patient Name, Patient ID and Accession Number.
Review and recall of stored dataVscan Extend – User Manual 5-395721203-100 Rev. DDICOM Store: exporting DICOM images from Vscan Extend to DICOM image serverAt the end of an exam, ensure the Patient ID is linked to the exam. This is required before exporting images or videos. See ‘Patient examination’ on page 5-7 for more information.1. Press Menu -> ExamsFigure 5-33. Exams2. Press the Export icon.Figure 5-34. ExportNOTE: Individual images from an exam or an entire exam can be selected for export.NOTE: At least one of the required fields in patient details need to be filled in before export is enabled.
Using Vscan Extend5-40 Vscan Extend – User Manual5721203-100 Rev. DDICOM Store: exporting DICOM images from Vscan Extend to DICOM image server (continued)3. If more than one storage destination is configured, select the desired destination.Figure 5-35. Choose destination4. Press Upload Selected to export the exam.Figure 5-36. Upload selected examThe selected exam(s) are exported to the DICOM server.
Review and recall of stored dataVscan Extend – User Manual 5-415721203-100 Rev. DDICOM Store: exporting DICOM images from Vscan Extend to DICOM image server (continued)5. A green icon indicates a successful export.A gray icon indicates the export was initiated and is pending upload.If an exported image does not successfully transfer to the DICOM server, a red icon appears next to the image.If the user did not attempt to export an image, no icon displays next to the image.NOTE: To refresh the screen to see the current status, exit the page and return to the same page.Figure 5-37. Transfer failedAll still images can be sent to the DICOM image server. Videos may be sent to the DICOM image server only if “Enable MultiFrame DICOM” is selected in the DICOM server configuration.Up to 100 images can be exported at one time.The multiframe video is limited to 4 seconds.NOTE: If the export is unsuccessful, it takes about 20 minutes until a failure message appears as the device attempts to resend the images/videos.
Using Vscan Extend5-42 Vscan Extend – User Manual5721203-100 Rev. DBackupIt is highly recommended to backup patient data on a microSD card, at regular intervals, to avoid data loss.The microSD card inside the device captures the error log files.Backup MUST be performed before sending the system to the repair depot as the data is wiped from the internal memory and cannot be retrieved.NOTE: The microSD card backup requires a length of time to process, the time being dependent on the number of images/videos requiring backup. For example, 1000+ videos in 50 to 60 exams takes approximately 14 minutes to back up to the microSD card.To backup patient data:1. Power OFF the Vscan Extend.2. Remove the Battery. See ‘Inserting/removing the battery’ on page 3-20 for more information. Remove the microSD card containing the log files from the device and insert a blank microSD card.3. Remove the microSD card containing the log files from the device and insert a blank microSD card. See Figure 6-3 on page 6-12 to insert the SD card.4. Press Menu -> Settings -> Backup.Figure 5-38. BackupWARNING It is important to retain these error logs. It is also recommended to perform a backup of these logs for specified dates. GE is not responsible for loss data of these logs.
Review and recall of stored dataVscan Extend – User Manual 5-435721203-100 Rev. DBackup (continued)5. A pop-up displays.Figure 5-39. Backup data messagePress Allow to initiate backup OR Cancel to stop the backup process.6. If the backup process is successful, the patient, exam, logs, and configuration data are backed up on the microSD card. The following message displays.Figure 5-40. Backup successful
Using Vscan Extend5-44 Vscan Extend – User Manual5721203-100 Rev. DBackup (continued)If the backup process is unsuccessful, a failed message displays.Figure 5-41. Backup failedNOTE: If the available memory on the microSD card is less than 50% when initiating backup, the process fails.Retry backup. If still unsuccessful, insert a new microSD card and try again.7. After backup is complete, power OFF the Vscan Extend. Remove the battery. Remove the backup microSD card and store in a safe place.8. Insert the original microSD card, containing the error logs, into the device. Power ON the Vscan Extend.
Review and recall of stored dataVscan Extend – User Manual 5-455721203-100 Rev. DRestoreNOTE: The restore operation does not restore backed up logs. 1. Power OFF the Vscan Extend.2. Remove the Battery. See ‘Inserting/removing the battery’ on page 3-20 for more information. Remove the microSD card containing the log files from the device and insert a blank microSD card.3. Remove the microSD card containing the log files from the device and insert the microSD card with the backed up data. See Figure 6-3 on page 6-12 to insert the SD card.4. Press Menu -> Settings -> Restore.Figure 5-42. RestoreCAUTION The restore procedure overwrites the existing data on the Vscan Extend. When restoring previously-backed up patient data, you must first backup the current patient data as the restore procedure overwrites the existing data. See ‘Backup’ on page 5-42 for more information.Make sure to insert the correct microSD card.
Using Vscan Extend5-46 Vscan Extend – User Manual5721203-100 Rev. DRestore (continued)5. A pop-up displays.Figure 5-43. Restore ConfirmationPress Allow to initiate restore OR Cancel to stop the restore process.6. If the restore procedure is successful, the patient, exam, and configuration data are restored to the device.If the restore procedure fails, a pop-up displays.Figure 5-44. Restore failedIf the microSD card does not contain any patient details to restore, a pop-up displays. The system automatically shuts down.Figure 5-45. Power off7. After restore is complete, power OFF the Vscan Extend. Remove the battery. Remove the backup microSD card and store in a safe place. The data is still retained on the microSD card.8. Insert the original microSD card, containing the error logs, into the device. Power on the Vscan Extend.
Using Vscan Extend AppsVscan Extend – User Manual 5-475721203-100 Rev. DUsing Vscan Extend AppsOverviewThere are four Apps avaiable on the Vscan Extend:• Bladder Volume• Lung Protocol• Tricefy UplinkBladder VolumeThe Bladder Volume App calculates the bladder volume using 3 distance measurements from two orthogonal images (transverse and sagittal).Two distances are taken from the transverse image and one distance from the sagittal image, at the widest points, to calculate the bladder volume.
Using Vscan Extend5-48 Vscan Extend – User Manual5721203-100 Rev. DInstalling the Bladder Volume application1. Press Menu -> Settings -> GE Marketplace.Figure 5-46. GE MarketplaceA list of available apps displays.2. Press Bladder Volume App to view details.3. Press Install. See ‘Installing Vscan Apps’ on page 4-32 for more information.The Bladder app installs.
Using Vscan Extend AppsVscan Extend – User Manual 5-495721203-100 Rev. DBladder Volume settings1. Press App Settings from the Settings menu. A pop-up displays.Figure 5-47. Bladder Volume app settings2. Press on the desired formula.Figure 5-48. Bladder volume formula• [0.7 x (D1 x D2 x D3)]• [0.52 x (D1 x D2 x D3)]
Using Vscan Extend5-50 Vscan Extend – User Manual5721203-100 Rev. DUsing Bladder VolumeTo use the bladder app, the following are prerequisites:• Install the app using GE Marketplace.• Phased array probe is active.• Live image is frozen.The Bladder Volume App runs an algorithm on the currently displayed image frame, finding the widest points on the bladder contour and placing the measurement calipers at these widest points.1. On the scanned transverse image, press to Freeze.The Bladder Volume App icon displays at the bottom of the screen.Figure 5-49. Bladder App icon2. Scroll to select a suitable frame.
Using Vscan Extend AppsVscan Extend – User Manual 5-515721203-100 Rev. DUsing Bladder Volume (continued)3. Press the Bladder icon to start the bladder measurement.The measurement cursors appear to perform the measurement.The widest points (D1 and D2) in a transverse image are perpendicular to each other.Figure 5-50. TransverseNOTE: The Transverse Measure screen is displayed by default.1. D1 - Longitudinal maximum length2. D2 - AP diameter
Using Vscan Extend5-52 Vscan Extend – User Manual5721203-100 Rev. DUsing Bladder Volume (continued)4. Adjust the measurement calipers manually, if required.5. Press Store. The screen enters sagittal capture.6. Press to Freeze. Scroll to select the best frame.7. Press Measure Frame.Figure 5-51. Measure FrameThe image, along with the measurement values and volume, displays.Figure 5-52. Measurement values8. Press Store.
Using Vscan Extend AppsVscan Extend – User Manual 5-535721203-100 Rev. DUsing Bladder Volume (continued)NOTE: The image is saved with the measurement values and volume embedded on it.View the saved images from the gallery.NOTE: The Bladder app cannot be used on stored images in the gallery.NOTE: If a sagittal image is acquired first and the step needs to be changed to sagittal, press the Sagittal toggle button.Figure 5-53. Toggle buttonExiting Bladder Volume1. Press Close to exit the Bladder Volume App.Figure 5-54. Exit Bladder Volume AppA pop-up displays for confirmation.2. Press Quit to exit the Bladder Volume app.3. Press Cancel to continue using the Bladder Volume app.1. Close 2. Quit
Using Vscan Extend5-54 Vscan Extend – User Manual5721203-100 Rev. DLung ProtocolLung Protocol application guides you through a step by step lung ultrasound exam.The application performs the following functions:1. Automatic lung preset selection2. Guides or helps assessing the stored images3. Helps to calculate a total lung score4. Generates a simple report at the end of the examInstalling the Lung Protocol application1. Press Menu -> Settings -> GE Marketplace.A list of available apps displays.2. Press Lung Protocol to view details.3. Press Install. The Lung Protocol app installs.Lung Protocol settings1. Press Start a protocol on the Menu screen.2. Press the Lung Protocols Settings icon on the Protocols screen to choose the desired settings.Figure 5-55. Start a protocol
Using Vscan Extend AppsVscan Extend – User Manual 5-555721203-100 Rev. DLung Protocol settings (continued)The Settings screen displays.Figure 5-56. SettingsThe Settings menu has the following functions:• choose the number of segments to be scanned• choose the type of assessment• enter the Help mode.Number of segmentsThree different configurations are available for the number of segments. Press on the radio button to choose any one of the following:• 4 x 2• 7 x 2• 6 x 2
Using Vscan Extend5-56 Vscan Extend – User Manual5721203-100 Rev. DLung Protocol settings (continued)Types of AssessmentTwo types of assessment are available. Press on the radio button to choose the desired type of assessment.• Quantitative• Qualitative.Help modeHelp mode is required to guide the user through the Lung Protocol. Swipe from left to right to turn ON the Help mode on the Lung Protocol Settings menu. See Figure 5-56 on page 5-55.Help mode assists in the following:• Skip - when you enter the next segment, swipe from right to left to skip the current segment.• Next - swipe from right to left to enter the next segment.• When multiple images are scored in the same segment, a pop-up appears:“Only latest saved image will be available for review”.
Using Vscan Extend AppsVscan Extend – User Manual 5-575721203-100 Rev. DLung Protocol settings (continued)3. Press the Back arrow to return to the Protocols screen.Figure 5-57. Back arrow4. Press Lung Protocol to start using the lung protocol.NOTE: The settings are automatically saved. If the settings need to be changed, stop the current protocol on the menu screen and modify the current settings on the Settings menu.Using Lung Protocol1. Press Menu.2. Press Start a protocol.3. Press Lung Protocol.Figure 5-58. Lung protocol
Using Vscan Extend5-58 Vscan Extend – User Manual5721203-100 Rev. DUsing Lung Protocol (continued)4. The lung linear preset is automatically applied. The lung preset is added as favorite in the Preset menu.Figure 5-59. Preset menuThe scan screen displays.Figure 5-60. Lung protocol scan screen5. Press Store to save the images or Cine loops for the current segment. The saved image icon appears at the upper left corner of the scan screen.6. Swipe from right to left to move to the next segment, for example 1R to 2R, where 1R is the first segment of the right lung. Similarly, 1L is the first segment of the left lung.ORSwipe from left to right to move to the previous segment.The number of segments that can be scored depends on the number of segments selected on the Settings menu.NOTE: The user is able to store multiple images per segment. Only the latest saved image, for a particular segment, is available for review. However, the user can view all the images in the Gallery under the current exam.NOTE: The appearance of the 'Gallery' icon indicates if an image and/or video is stored in the segment. 1. Displays current segment name2. Displays previous, current and next segments
Using Vscan Extend AppsVscan Extend – User Manual 5-595721203-100 Rev. DReview and score imagesAfter all the images are stored for all the segments, a pop-up displays:Figure 5-61. Score imagesPress Score to score the images. Choose the score for each segment.ORPress Go Back to acquire more images.Depending on the type of assessment chosen on the Lung Protocol Settings menu, either Quantitative or Qualitative assessment scores are displayed. Both the screens are shown below.Figure 5-62. Quantitative and Qualitative ScoresNOTE: It is not mandatory to score all images.1. Quantitative 2. Qualitative
Using Vscan Extend5-60 Vscan Extend – User Manual5721203-100 Rev. DLung Protocol reportAfter reviewing and scoring the last segment, swipe from right to left to enter the report screen.The report shows the current patient name, patient ID, and total lung score.Figure 5-63. Quantitative reportFigure 5-64. Qualitative reportPress Save to save the report. The report is stored with all the images and videos from the gallery.Press Exams on the Menu screen to view the images and the report.
Using Vscan Extend AppsVscan Extend – User Manual 5-615721203-100 Rev. DExit Lung Protocol1. Press Menu on the Lung protocol screen.2. Press Stop current protocol. A pop-up displays. Figure 5-65. Stop current protocol3. Press Exit to stop the protocol.
Using Vscan Extend5-62 Vscan Extend – User Manual5721203-100 Rev. DTricefyTricefy Uplink helps to upload exams to the cloud.1. Press Menu -> Settings -> GE Marketplace2. Press Install. The Tricefy Uplink app installs.Using Tricefy1. Press Menu -> Settings -> Server Settings2. Press Tricey under Image Server Figure 5-66. Tricefy
Using Vscan Extend AppsVscan Extend – User Manual 5-635721203-100 Rev. DUsing Tricefy (continued)3. Enter your email address to register for Tricefy and press Activate. OR if you have a Tricefy login, enter that address and press Login.Figure 5-67. Tricefy Activate or login4. Press Add Server and Verify.Figure 5-68. Add Ticefy and Verify
Using Vscan Extend5-64 Vscan Extend – User Manual5721203-100 Rev. DUsing Tricefy (continued)5. Press Menu -> Export icon.Figure 5-69. Export6. Press Upload Selected to export the exam.Figure 5-70. Upload selected examThe selected exam(s) are exported to the Tricefy server.
Vscan Extend – User Manual 6-15721203-100 Rev. DChapter 6Vscan Extend MaintenanceContents‘System care and maintenance’ on page 6-2‘Inspection’ on page 6-3‘Upgrade software’ on page 6-12‘Troubleshooting’ on page 6-14
Vscan Extend Maintenance6-2 Vscan Extend – User Manual5721203-100 Rev. DSystem care and maintenanceOverviewThe Vscan Extend requires regular care and maintenance to function safely and properly.The expected service life of the Vscan Extend is 5 years.To ensure that the Vscan Extend constantly operates at maximum efficiency, we recommend that the following procedures be observed as part of the customer’s internal routine maintenance program.CAUTION The user must ensure that safety inspections are performed at least every 12 months according to the requirements of the patient safety standard EN/ES/IEC 60601-1 and its national deviations or according to the requirements of the IEC62353 standard, medical electrical equipment – recurrent test and test after repair of medical electrical equipment.Only trained persons should perform the safety inspections.
System care and maintenanceVscan Extend – User Manual 6-35721203-100 Rev. DInspectionInspecting the Vscan ExtendExamine the following on a monthly basis (or whenever there is a reason to assume that any issue may have occurred):• Connectors on cables, for any mechanical defects• Entire length of electrical cables, for cuts or abrasions• Equipment for cracks, loose or missing hardware.Before each use1. Inspect the lens, the probe housing and the cable.2. Look for damage that might allow liquid into the probe.3. Test the functionality of the probe.CAUTION If any defects or damages are found on the control unit, the probe or its cable, DO NOT use the Vscan Extend. Contact GE service.WARNING To avoid electrical shock hazard, do not remove covers from the Vscan Extend.
Vscan Extend Maintenance6-4 Vscan Extend – User Manual5721203-100 Rev. DCleaning and disinfectionCleaning the deviceMake sure the device is disconnected from the AC/DC adapter before cleaning.1. Power off the Vscan Extend.2. Moisten a soft, non-abrasive cloth with a mild, general purpose, non-abrasive soap and water solution.3. Wipe the Vscan Extend.4. Wipe dry with a soft towel.Reprocessing recommendation (Frequency)After Each Use• Inspect the transducer (see ‘Inspecting the Vscan Extend’ on page 6-3)• Clean the transducer (see ‘Disinfecting the probe’ on page 6-9).• If required, clean the device and the display (see ‘Disinfecting the device’ on page 6-7).• If required, disinfect the transducer (see ‘Disinfecting the probe’ on page 6-9).Ensure that the main unit and the transducer are properly cleaned after each use and before storage in the case.CAUTION Do not spray the soap and water solution directly onto the Vscan Extend.WARNING If any defects or damages are found on the probe or its cable, DO NOT use the Vscan Extend. Contact GE service.
Cleaning and disinfectionVscan Extend – User Manual 6-55721203-100 Rev. DSpecial Label Designations, Warnings and PrecautionsNever use thinner, benzene, abrasive cleaners, or other strong solvents, as these may cause damage to the Vscan Extend.Do not soak or saturate probes with solutions containing bleach, ammonium chloride compounds or hydrogen peroxide.Special accessoriesSpecial accessories are not applicable.Point-of-Use ProcessingNo point-of-use processing is required prior to cleaning.
Vscan Extend Maintenance6-6 Vscan Extend – User Manual5721203-100 Rev. DCleaning instructionsCleaning the probe1. Remove the gel by wiping the probe lens with a soft cloth.2. Wipe the probe and cable with a soft cloth moistened with a warm soap and water solution (<80 0F/27 0C).3. Wipe the probe and cable with a soft cloth moistened with clean water (<80 0F/27 0C) until all soap is removed.4. Wipe dry with a soft towel.Cleaning the USB door1. Open the USB door.2. Wipe the inside of the door with a soft cloth moistened with a mild, general purpose, non-abrasive soap and water solution.3. Wipe dry with a soft cloth. Figure 6-1. Open the USB doorMethod of cleaning: ManualCAUTION Avoid any liquid making contact with the internal device components, including the micro USB connector and battery terminal contacts, which are not designed for making contact with liquids.CAUTION DO NOT use brush, abrasives, sharp tools or any other methods that may damage the inside or surface of the device.DO NOT scratch or press any part of the Vscan Extend with a sharp object, such as pencils or pens, as this may result in damage to Vscan Extend.
Cleaning and disinfectionVscan Extend – User Manual 6-75721203-100 Rev. DDisinfecting the deviceAfter cleaning, the device may be wiped with a tissue sprayed with a recommended germicide.Recommended germicidesIn order to provide users with options in choosing a germicide, GE routinely reviews new medical germicides for compatibility with the Vscan Extend and its probe. Although a necessary step in protecting patients and employees from disease transmission, liquid chemical germicides must also be selected to minimize potential damage to the probe.NOTE: Refer to the cleaning agent labeling for preparation and use instructions.NOTE: Follow the manufacturer's instructions for storage, use and disposal of the disinfection solution.NOTE: No special accessories are required for disinfection.Table 6-1: Germicides PI-Spray Pharmaceutical InnovationsPI-Spray II Pharmaceutical InnovationsCaviWipes MetrexCleanisept wipes Dr. Schumacher GmbHSeptiwipes Dr. Schumacher GmbHSani-Cloth HB PDIWARNING Use only compatible germicides. In addition, refer to the local / national regulations.
Vscan Extend Maintenance6-8 Vscan Extend – User Manual5721203-100 Rev. DCleaning agentsFollow the instructions described below while using CaviWipes and Sani-Cloth HB.CaviWipes1. Use one CaviWipes towelette to completely preclean the surface of the device, probe and cable.2. Ensure that no debris and bioburden are left behind.3. Discard used towelette.4. Use a second CaviWipes towelette to thoroughly wet the surface in order to disinfect the precleaned surface. Repeated use of the product may be required to ensure that the surface remains visibly wet for 3 minutes at room temperature (20 degrees).Sani-Cloth HB1. Use one Sani-Cloth HB towelette to completely preclean the surface of the device, probe and cable2. Ensure that no debris and bioburden are left behind.3. Discard used towelette.4. Use a second Sani-Cloth HB towelette to thoroughly wet the surface in order to disinfect the precleaned surface. Repeated use of the product may be required to ensure that the surface remains visibly wet for 10 minutes at room temperature (20 degrees).
Cleaning and disinfectionVscan Extend – User Manual 6-95721203-100 Rev. DDisinfecting the probeAfter cleaning, the probe and cable may be wiped with a tissue sprayed with a recommended germicide.In order to provide users with options in choosing a germicide, GE routinely reviews new medical germicides for compatibility with the materials used in the transducer housing, cable and lens. Although a necessary step in protecting patients and employees from disease transmission, liquid chemical germicides must also be selected to minimize potential damage to the probe.Refer to the internet link below for the latest list of compatible cleaning solutions and disinfectants:http://www3.gehealthcare.com/en/Products/Categories/Ultrasound/Ultrasound_ProbesWARNING Never use any cleaning solutions and disinfectants other than the ones mentioned in the Ultrasound Probes web page.
Vscan Extend Maintenance6-10 Vscan Extend – User Manual5721203-100 Rev. DDisinfecting the probe (continued)Figure 6-2. Probe immersion levelWARNING Do not immerse the probe in any liquid beyond the level specified (see Figure 6-3). The probe should not be exposed to the germicide longer than specified in order to achieve the desired effect.Rinse the part of the probe which is in contact with the germicide according to the germicide manufacturer’s instructions.Wipe dry with a soft towel.1. Maximum saline level2. Minimum saline levela. Linear array transducerb. Phased array transducerc. G3S probeWARNING Use additional precautions (e.g. gloves and gown) when decontaminating an infected probe.The probe should not be exposed to the germicide longer than specified in order to achieve the desired effect.
Cleaning and disinfectionVscan Extend – User Manual 6-115721203-100 Rev. DDisinfecting the probe (continued)Rinsing and Lubricating AgentsNo rinsing and lubricating agents are required.WARNING CREUTZFELDT-JAKOB DISEASEThis device is not indicated for neurological use. Neurological contact on patients with this disease MUST BE avoided. If a device/probe becomes contaminated, there is no adequate means to disinfect it. In this case, the contaminated device/probe MUST BE discarded in accordance with local biologic waste hazard procedures.BiologicalHazard
Vscan Extend Maintenance6-12 Vscan Extend – User Manual5721203-100 Rev. DUpgrade softwareScanner softwareYou can upgrade the currently installed software to a software version equal to or greater than your current version.NOTE: Before proceeding with the upgrade, ensure that the battery is fully charged and the charger is plugged in. To perform a software upgrade:1. Remove the battery. See ‘To remove the battery’ on page 3-20 for more information.2. Remove the microSD card that captures the error log files from the device (lightly push the SD card holder and pull out the SD card). 3. Insert the application software microSD card.Figure 6-3. Insert SDcard
Upgrade softwareVscan Extend – User Manual 6-135721203-100 Rev. DScanner software (continued)4. Press Settings on the Menu screen.5. Press System Settings.6. Press Upgrade Software.The following message displays:Current software version is:New software version is:7. Press OK to proceed with the upgrade. NOTE: You cannot upgrade the Scanner software to a software version lower than the currently installed software. If you try to do so, a message displays: “Not allowed to proceed”.The Vscan Extend may have security patches which need an update.WARNING GE is not responsible for any virus affecting the Vscan Extend device which may result in data loss.
Vscan Extend Maintenance6-14 Vscan Extend – User Manual5721203-100 Rev. DTroubleshootingVscan Extend troubleshootingTable 6-2: Troubleshooting Problem Possible cause SolutionVscan Extend has no power. Battery not inserted. Insert battery (see page 3-20)Battery not charged. Charge the battery (see page 3-18)Battery defect or end of life. Contact GE Service (see page 1-10)Broken battery connection. Contact GE Service (see page 1-10)Vscan Extend is not charging. Battery not inserted. Insert battery (see page 3-20)Battery defect or end of life. Contact GE Service (see page 1-10)Broken battery connection. Contact GE Service (see page 1-10)Defective AC adapter or charger. Contact GE Service (see page 1-10)Mains power is down.Temperature is outside the specified limits.Ensure the ambient temperature is within the specified limits (see ‘Environmental requirements for the device’ on page 3-3)Display screen is blank when the device is powered on.Connection broken during software loading.Contact GE Service (see page 1-10)Parts of the image is missing when scanning.Channels are missing. Contact GE Service (see page 1-10)Noise when moving the probe cable.Defective probe cable. Contact GE Service (see page 1-10)No image displayed when scanning.Defective probe. Contact GE Service (see page 1-10)
TroubleshootingVscan Extend – User Manual 6-155721203-100 Rev. DVscan Extend display is flashing while scanning.Automatic reduction of the frame rate due to increase of the operating temperature after extended scanning.Restart the Vscan Extend to restore the normal frame rate. NOTE: To maintain the operating temperature of the Vscan Extend at an optimal functional level, it is recommended to hold the Vscan Extend so there is good contact between the device and the hand. This will also ensure a longer scanning time with maximum frame rateVscan Extend is not entering the scan screen and stays on the GE start-up screen.Battery may not have sufficient charge.Charge the Vscan Extend battery for at least 60 minutes.Table 6-2: Troubleshooting (Continued)Problem Possible cause Solution
Vscan Extend Maintenance6-16 Vscan Extend – User Manual5721203-100 Rev. DSystem Warning MessagesSystem errors• System overheats• Probe overheats• Battery low• System voltage criticalWARNING System is overheating and will shut down.If the problem persists, contact GE service.WARNING Probe is overheating and the system will shut down.If the problem persists, contact GE service.WARNING Battery is critically low or below 15%. Plug in charger.WARNING System voltage is at critical level and will shut down.If the problem persists, contact GE service.
TroubleshootingVscan Extend – User Manual 6-175721203-100 Rev. DSystem Warning Messages (continued)• Connectivity error• Acquisition levelSystem messages• Perform system backup• Scanning not allowedWARNING Unable to connect. Check Wi-Fi connection.WARNING Check battery and recharge the system.If the problem persists, contact GE service.WARNING System internal memory usage is 50 to 60%.Perform system backup.WARNING Scanning is not allowed when AC is connected.WARNING Scanning is not allowed when connected to a PC.
Vscan Extend Maintenance6-18 Vscan Extend – User Manual5721203-100 Rev. D
Vscan Extend – User Manual 7-15721203-100 Rev. DChapter 7AppendixContents:‘Specifications’ on page 7-2‘Acoustic Output Reporting Tables’ on page 7-3‘Measurement accuracy’ on page 7-12
Appendix7-2 Vscan Extend – User Manual5721203-100 Rev. DSpecificationsDimension and weightSystem dimension and weight• Main unit (approximately): 170 x 78 x 21 mm• Weight (Main unit with Sector probe, without battery): 365g• Weight (Main unit with Dual probe, without battery): 400g• Battery Weight: 65gProbe dimension and weight• Dimension (L x B x H) Sector Probe:129 x 32 x 25 mm• Dimension (L x B x H) Dual Probe: 129 x 39 x 28 mm• Sector probe Weight (including cable): 85g• Dual probe Weight (including cable): 120gPhased array transducer for deep scanning• Field-of-view for black and white imaging: up to 70 degrees with maximum depth of 24 cm• The color flow sector represents blood flow within an angle of 40 degrees.• Broad-bandwidth sector probe: from 1.7 to 3.8 MHz• Footprint: 13 x 19 mmLinear transducer for shallow scanning• Field-of-view for black and white imaging: aperture width of 2.9 cm with maximum depth of 8 cm• The color flow sector represents blood flow over image with full aperture and entire depth.• Broad-bandwidth linear probe: from 3.3 to 8.0 MHz• Footprint: 9 x 35 mm
Acoustic Output Reporting TablesVscan Extend – User Manual 7-35721203-100 Rev. DAcoustic Output Reporting TablesDefinitions, symbols and abbreviationsThe following definitions, symbols and abbreviations are used in the acoustic output reporting tables in this chapter:Table 7-1: Definitions, symbols and abbreviationsIEC FDA Meaning—IEC 60601-2-37 / FDA & NEMA UD2, UD3Acoustic Attenuation Coefficient / Derating factor (usually 0.3 dB/cm-MHz)-12db Output Beam Area / Active aperture areaNormalizing CoefficientEquivalent Aperture Diameter / (same)Pulse Beam Width / Beam diameter at –6 dBEquivalent Beam DiameterAcoustic Working Frequency / Center frequencyPulse-Average IntensityAttenuated Pulse-Average IntensityPulse-Intensity IntegralAttenuated Pulse-Intensity IntegralTemporal-Average IntensityAttenuated Temporal-Average Intensity / (at depth z)Spatial-Peak Temporal-Average IntensityAttenuated Spatial-Peak Temporal-Average IntensityMechanical IndexOutput Power / Time average acoustic power at the sourceAttenuated Output Power / Time average acoustic power derated to depth z
Appendix7-4 Vscan Extend – User Manual5721203-100 Rev. DBounded Output Power / Power emitted from the central 1cm of aperturePulse Pressure Squared Integral / Pulse intensity integralPeak-Rarefactional Acoustic Pressure / (same)Attenuated Peak-Rarefactional Acoustic Pressure / (same)Pulse Repetition Rate / Pulse repetition frequencyThermal Index / (same)Bone Thermal Index / (same)Cranial-Bone Thermal Index / (same)Soft-Tissue Thermal Index / (same)Pulse Duration / (same)-12 dB Output Beam Dimensions / (same)Distance from the Source to a Specified Point / (same)Depth for TIB / Depth at which the relevant index is maximumBreak-Point Depth / (same)Depth for TIS / Depth at which the relevant index is maximumTable 7-1: Definitions, symbols and abbreviations (Continued)IEC FDA Meaning—IEC 60601-2-37 / FDA & NEMA UD2, UD3
Acoustic Output Reporting TablesVscan Extend – User Manual 7-55721203-100 Rev. DExplanation of FootnotesThe mechanical and thermal indices may be replaced by one of the following footnotes because of the reasons listed:• a: Display of this index is not required for this operating mode.• b: This probe is not intended for transcranial or neonatal cephalic uses.If so, the table entries are replaced by a “#”, meaning: no data are provided for this operating condition since the maximum reported value is not reported for the reason listed.If neither an index or a footnote is given, this means that the index is irrelevant for this probe/mode combination.Operating ConditionsAll table entries are with the operating conditions specified at the end of the table.
Appendix7-6 Vscan Extend – User Manual5721203-100 Rev. DAcoustic Output Reporting Tables for Track 3/EN/IEC 60601-2-37 Dual ProbePhased array transducerOperating Mode: black/white Figure 7-1. Phased array transducer - black/white
Acoustic Output Reporting TablesVscan Extend – User Manual 7-75721203-100 Rev. DDual ProbePhased array transducerOperating Mode: black/white and color Figure 7-2. Phased array transducer - black/white and color
Appendix7-8 Vscan Extend – User Manual5721203-100 Rev. DDual ProbeLinear array transducerOperating Mode: black/white Figure 7-3. Linear array transducer - black/white
Acoustic Output Reporting TablesVscan Extend – User Manual 7-95721203-100 Rev. DDual ProbeLinear array transducerOperating Mode: black/white and color Figure 7-4. Linear array transducer - black/white and color
Appendix7-10 Vscan Extend – User Manual5721203-100 Rev. DSector probePhased array transducer G3SOperating Mode: black/white Figure 7-5. Phased array transducer - black/white
Acoustic Output Reporting TablesVscan Extend – User Manual 7-115721203-100 Rev. DSector probePhased array transducer G3SOperating Mode: black/white and color Figure 7-6. Phased array transduce - black/white and color
Appendix7-12 Vscan Extend – User Manual5721203-100 Rev. DMeasurement accuracyBasic MeasurementsThe following information is intended to provide guidance to the user in determining the amount of variation or measurement error that should be considered when performing clinical measurements with this equipment. Error can be contributed by equipment limitations and improper user technique. Be sure to follow all measurement instructions and develop uniform measurement techniques among all users to minimize the potential operator error. Also, in order to detect possible equipment malfunctions that could affect measurement accuracy, a quality assurance (QA) plan should be established for the equipment that includes routine accuracy checks with tissue mimicking phantoms.Please be advised that all distance and Doppler related measurements through tissue are dependent upon the propagation velocity of sound within the tissue. The propagation velocity usually varies with the type of tissue, but an average velocity for soft tissue is assumed. This equipment is designed for, and the accuracy statements listed on are based on, an assumed average velocity of 1540 m/s. The percent accuracy when stated applies to the measurement obtained (not the full scale range). Where the accuracy is stated as a percent with a fixed value, the expected inaccuracy is the greater of the two.Table 7-2: Measurement accuracy Measurement Unit Useful range Accuracy ProbeDistanceAxial cm Full screen ±3% or ±1 mm, whichever is greaterBoth probesLateral cm Full screen ±5% or ±1 mm, whichever is greaterShallow
Measurement accuracyVscan Extend – User Manual 7-135721203-100 Rev. DSpeed of Sound in TissueThe average value 1540 meters / second is used for all calculations. Depending on the tissue structures, this generalization may give errors from 2% (typical) to 5% (much fatty tissue layers present).
Appendix7-14 Vscan Extend – User Manual5721203-100 Rev. D
Vscan Extend – User Manual 8-15721203-100 Rev. DChapter 8Privacy and SecurityContents‘Introduction’ on page 8-2‘Privacy and Security Environment’ on page 8-3‘Privacy and Security Capabilities’ on page 8-3‘Network Connectivity’ on page 8-6‘Information Protection’ on page 8-9‘Personal Information Collected by the Product’ on page 8-17
Privacy and Security8-2 Vscan Extend – User Manual5721203-100 Rev. DIntroductionOverviewThis chapter describes Privacy and Security considerations for the use of the Vscan Extend. It describes the expected intended use, the Privacy and Security capabilities included, and how they are configured and used appropriately.This chapter assumes that the reader understands the concepts of Privacy and Security. Privacy is the property of protecting the personal private interests of patients. Security protects both system and information from risks to confidentiality, integrity, and availability. Security protects Privacy but also protects more broadly against these risks. Privacy requires security. In Healthcare one must balance privacy, security, and safety. Most of the time there isn’t a conflict between these three domains of risk. The healthcare provider organization is encouraged to use risk management procedures to assess and prioritize privacy, security, and safety risks. Through the use of risk management one can determine how to best leverage the capabilities provided in the Vscan Extend Ultrasound product.How to contact GEFor privacy and security concerns regarding GE products, please see: http://www.ge.com/security
IntroductionVscan Extend – User Manual 8-35721203-100 Rev. DPrivacy and Security EnvironmentThe GE Healthcare Vscan Extend Ultrasound product has been designed for an intended use with the following expectations of Privacy and Security protections included in the environment where this product will be used:1. The system should be connected to a secured network, not open to unintended users.2. The Vscan Extend should be physically secured in a way that it is not accessible for unintended users.3. The Vscan Extend supports device PIN-based management.4. External media (microSD card) containing images, patient data, reports and logs should be secured. When no longer used, the data should be securely erased and/or the media should be securely deleted.5. The display of the Vscan Extend should be placed in a way limiting the visibility to the user only.Privacy and Security CapabilitiesThe GE Healthcare Vscan Extend incorporates a broad assortment of capabilities to enable Privacy and Security. This section describes the capability and use of these Privacy and Security capabilities.Access ControlsThe access control features may be used to help control access to sensitive information. Access control includes user account creation and assigning privileges.Identity ProvisioningThe Vscan Extend device supports PIN authentication. A PIN is created by the user when accessing the device and storing the image for the first time.The device provides PIN access at two levels:1. Storage access2. Admin accessThe user MUST set the Admin PIN when trying to access the Admin mode.
Privacy and Security8-4 Vscan Extend – User Manual5721203-100 Rev. DPIN restrictionsThe restrictions on a PIN are:1. The PIN should be 4-digits long.2. When the device is idle for a certain amount of time set in the session duration, it is the reponsibility of the user to ensure that the device is not used by unauthorized individuals as it may lead to data loss.User AuthenticationThe Vscan Extend device is operated using a PIN. Only one PIN is used by different users to access the device. The Vscan Extend does not support user profiles.Assigning Access RightsThe Admin mode is used to change the System level configuration.A user can access the Admin mode by entering the Admin PIN.Patient Privacy Consent ManagementPatient Privacy Consent Management is the process to support the patient to express their privacy requirements. This is different from other forms of consent such as the consent to treat.There is no integrated functionality in the system for Patient Privacy Consent Management. If needed, operational routines must be established.Privacy and Security Audit Logging and Accountability ControlsPrivacy and Security Audit Logging and Accountability Controls support Security surveillance and Privacy investigations and reporting.The Vscan Extend has an integrated functionality for audit logging, including audit logging of privacy related events.
IntroductionVscan Extend – User Manual 8-55721203-100 Rev. DAudit logging content The following events are captured by the audit logging of the Vscan Extend:1. Device Start/Shut-down time2. Incorrect password attempts3. Addition and Modifications to system configuration, including:a. DICOM connection b. Windows Share connectionc. Application software installation/uninstallation/software upgraded. Registration of partnering apps4. Events related to Patient Data, including details of:e. Data access Date/Time including type of action (addition, deletion, modification, reviewed) excluding the PC connect scenariof. Details of applications used (Bladder app, Lung protocol, etc.)5. Data Exporta. Data export Date/Time including end point and Wi-Fi SSID informationb. Data Backup/Restore detail6. Invalid Device PIN attempt7. Kiosk admin mode login success and failureManagement of Audit logsBack up of audit logsBack up of audit logs can be done by exporting audit logs to an external device. The export happens through USB export.Remember that audit logs and exported audit log files do contain Personal Information (PI) and must be handled according to applicable regulations and guidelines for handling of PI/PHI.Note that exported audit log files are stored unencrypted.
Privacy and Security8-6 Vscan Extend – User Manual5721203-100 Rev. DNetwork ConnectivityOverviewNetwork connection for the Vscan Extend is required by several system features:1. DICOM connectivity to other DICOM devices2. Disk Management/Backup towards Windows share3. Image/Video storage via the “JPG/MPEG” featureSystem interconnectionsThe figure below shows the possible interconnections for the Vscan Extend Ultrasound system. For a particular installation, typically a subset of the interconnections is utilized.Figure 8-1. Vscan Extend network diagram1. GE Health Cloud2. Hospital Public Wireless infrastructure3. Vscan Extend Device4. Hospital Clinical Network5. PACS6. Hospital Clinical Wireless infrastructure7. Windows PC
Network ConnectivityVscan Extend – User Manual 8-75721203-100 Rev. DSystem interconnections (continued)Device features• Supported WirelessProtocols include WEP, WPA2 with PSK and EAP with certificates• Log files• Data backup/restore• Software upgradeWireless Networks are configured by Hospital IT administrators or device owners. The Wi-Fi encryption depends upon on the hospital IT infrastructure and the device enterprise grade protocols with the certificate mechanism.DICOM image transfer and anonymized images/video transfer to a Windows machine is supported over a hospital clinical wireless network and a hospital public wireless service that are used for GE cloud connectivity to push the data using SSL/TLS.The table below describes interconnections in more detail:For details regarding protocols, port numbers and firewall configurations see ‘Inbound firewall configuration’ on page 8-10, ‘Outbound firewall configuration’ on page 8-11.Table 8-1: InterconnectionsSource/destination Network service DescriptionPACS/DICOM server DICOM Optional connection to PACS/DICOM server for patient and image archiving/retrieval. DICOM storage, DICOM Query/Retrieve and DICOM Worklist are supportedWindows share Windows file sharing Some dataflows can be configured to use a windows share as output. This includes MPEG, videos.USB export USB cable If the feature is enabled, an USB cable can be connected to a PC for exporting images and videos.
Privacy and Security8-8 Vscan Extend – User Manual5721203-100 Rev. DNetwork RequirementsHost Characteristic1. TCP/IP network2. Both DHCP and static IP allocation are supportedNetwork ProtocolsWireless network protocols The following wireless protocols are supported:1. IEEE 802.11b2. IEEE 802.11g3. IEEE 802.11nInternet Protocol Version:1. IPv4 2. IPv6
Information ProtectionVscan Extend – User Manual 8-95721203-100 Rev. DInformation ProtectionOverviewThis section of the manual focuses on Privacy and Security operations, and contains information to guide in the preparation of a secure environment for the Vscan Extend Ultrasound system.Security operations is best implemented as part of an overall “defense in depth” information assurance strategy; this is used throughout an Information Technology system that addresses personnel, physical security and technology. The layered approach of defense in depth limits the risk that the failure of a single security safeguard will allow compromise of the system.Network Security GE strongly recommends that medical information systems are operated in a secure network environment that is protected from unauthorized intrusion. There are many effective techniques for isolating and protecting medical information systems, including implementing firewall protection, demilitarized zones (DMZs), Virtual Local Area Networks (VLANs) and network enclaves.To assist in secure network design, the following network profile outlines the required network services for the Vscan Extend Ultrasound system.The Vscan Extend is supported with an internal firewall. The following two sections describe the configuration of the firewall and the guidance for configuring the IT infrastructure where it is connected.
Privacy and Security8-10 Vscan Extend – User Manual5721203-100 Rev. DInbound firewall configurationAll inbound connections are blocked by the Vscan Extend Ultrasound system’s internal firewall, with the exemptions listed in the table below.The column “Recommended configuration of network infrastructure” describes the suggested configuration of the network infrastructure regarding the different network services.Table 8-2: Inbound Firewall configurationLocal port Remote port Protocol ProgramsRecommended configuration of network infrastructure Network service1041Any TCP All Open to DICOM server(s) connected to the Vscan Extend, but only if DICOM Retrieve is used. Closed towards internet.DICOM Retrieve from connected DICOM server(s)1 Port 104 or another port configured for the DICOM Retrieve service.
Information ProtectionVscan Extend – User Manual 8-115721203-100 Rev. DOutbound firewall configurationAll outbound connections are blocked by the Vscan Extend Ultrasound system’s internal firewall, with the exemptions listed in the table below.The column “Recommended configuration of network infrastructure” describes the suggested configuration of the network infrastructure regarding the different network services.Table 8-3: Inbound Firewall configurationLocal port Remote port Protocol ProgramsRecommended configuration of network infrastructure Network serviceAny 1042TCP DICOM Open to DICOM server(s) connected to the Vscan Extend. Closed towards internet.DICOM storeAny 1043TCP DICOM Open to DICOM server(s) connected to the Vscan Extend, but only if DICOM Query is used. Closed towards internet.DICOM QueryAny 1044TCP DICOM Open to DICOM server(s) connected to the Vscan Extend, but only if DICOM Worklist is used. Closed towards internet.DICOM WorklistAny 445 TCP Windows ShareWindows Windows Share2 Port 104 or another port configured for the DICOM Storage service.3 Port 104 or another port configured for the DICOM Query service.4 Port 104 or another port configured for the DICOM Worklist service.
Privacy and Security8-12 Vscan Extend – User Manual5721203-100 Rev. DLocal Archive - Security capabilities The Vscan Extend is provided with an internal archive, for storing images and patient data locally on the system. The local archives file repository and patient database do not support file sharing or remote connection. These can only be accessed locally. The patient database is protected with the authentication for access requirements and no possibility of remote access.DICOM connections – Security capabilitiesThe DICOM connection works as defined by DICOM guidelines. The application accepts connection only to/from DICOM entities with IP-address, AE Title and port number matching the configured parameters in the Vscan Extend Ultrasound system.The communication sessions are on demand and are always initiated locally from the system.The Vscan Extend Ultrasound system’s internal firewall has exemptions for ports used by the defined DICOM dataflows in the system. Defining a new DICOM dataflow, or changing an existing dataflow, will cause the internal firewall configuration to automatically change. This ensures that only ports configured for a dataflow have an exemption in the internal firewall.Windows shareWindows share access can be secured by defining a dedicated user on the server side. The user credentials for the network share user must be entered in the configuration UI on the Vscan Extend Ultrasound system.NOTE: There is no network file share on the Vscan Extend Ultrasound system.Network infrastructureThe infrastructure of the network where the Vscan Extend is connected must be configured to allow traffic as described in Inbound firewall configuration and Outbound firewall configuration sections. All other traffic to and from the Vscan Extend can be blocked in the network infrastructure to prevent unintended access.
Information ProtectionVscan Extend – User Manual 8-135721203-100 Rev. DWireless SecurityDue to the broadcast nature of wireless communication, wireless devices require special security considerations. There are effective techniques and tools for improving the security of wireless communication devices.Wireless security protocolsThe following security protocols are supported on the wireless interface:1. WEP2. WPA/WPA2 PSK3. 802.1x EAP - (PEAP, TLS, TTLS, PWD, SIM, AKA)Removable Media Security Data stored on removable media, such as a microSD card, is stored encrypted on the media. The storage device and the content on the storage device must be physically protected and handled according to applicable regulations and guidelines for handling personal information (PI) / protected health information (PHI).Data can also be exported through a USB cable to a PC. Only the images or videos will be exported. The patient information will not be displayed.Removable media on the Vscan Extend Ultrasound systemThe Vscan Extend supports USB cable connection to export images and videos to a PC.The removable microSD cards are used for the following: 1. Backup encrypted patient data – empty microSD card2. Error log storage – original microSD card delivered with the Vscan Extend3. Upgrade the application software – Application microSD card
Privacy and Security8-14 Vscan Extend – User Manual5721203-100 Rev. DData destruction for portable mediaThe Vscan Extend does not have the internal functionality to securely delete data stored on the removable devices.Approved procedures and tools should be used to securely remove data stored on removable media, according to applicable regulations and guidelines for handling patient information / personal information (PI) / protected health information (PHI).Data at Rest SecurityPatient data is encrypted and images/videos/logs are unencrypted.Back-upThe Vscan Extend backup feature stores data in an encrypted format. Only images are backed up; no patient information is displayed.The backup device must be secure, whether it is removable media or a server, to ensure no unauthorized intrusion.External dataflowsThe Vscan Extend supports interconnections to external storage systems. This includes connections to Remote Archives (Windows Share) and DICOM servers. The security of data stored on these systems must be secure.d on the external storage system (outside the scope of the Vscan Extend Ultrasound system).Data Integrity CapabilitiesTo ensure the integrity of any software update, the Vscan Extend has additional security installed to detect any malicious modifications to a software update package.Integrity assurance is implemented to software updates packages for the Vscan Extend Ultrasound system. Malicious modifications to a software update packages will be discovered at install time, and the installation of the malicious software will be prohibited.The Vscan Extend has integrated audit log capabilities that logs changes to the data. See ‘Privacy and Security Audit Logging and Accountability Controls’ on page 8-4 for more information.
Information ProtectionVscan Extend – User Manual 8-155721203-100 Rev. DBusiness ContinuityTo ensure business continuity, several options must be considered related to data storage. The target for the images and patient archive must be chosen to ensure safe storage of the data. Both internal and external alternatives are supported.Patient archive solutionsThe Vscan Extend supports several alternatives for storing images and patient information, both internal and external:1. Local Archive: local storage on the Vscan Extend Ultrasound system2. Remote Archive: Only anonymized images can be stored on Windows share. Patient information is not visible.3. DICOM storage: storage on DICOM/PACS serverSee ‘System interconnections’ on page 8-6 for more information.Securing data on Local Archive and Local Archive SharedIf local archive is used, backup and/or transfer procedures must be established for the local archive. If disk management is not performed within a pre-defined period, a warning message displays.Securing data on Remote Archive and DICOM/PACS serversIf external archive is used, a backup procedure must be established for the external archive. The business contingency planning of data stored on DICOM/PACS servers is outside the scope of this document.Off-line modeThe Vscan Extend can operate in stand-alone mode, with the use of Local Archive. If there are data network related problems, which prevents the Vscan Extend from connecting to an external patient archive, the device can be fully functional by storing patient data/images to the Local Archive.
Privacy and Security8-16 Vscan Extend – User Manual5721203-100 Rev. DSystem ProtectionVscan Extend – system protectionThe System needs to be configured and maintained in a way that continually protects Privacy and Security.The GE Healthcare Vscan Extend contains additional features to improve local operational security.No system accessUsers of the Vscan Extend do not have access to the Android system nor to the MST system (Linux) on the Vscan Extend Ultrasound system.Hence the users will have no access to internet web-browsing, e-mail clients, installing any software on the system nor adding files (except for application related files through the application)Android features controlledAndroid operating system is controlled through an Admin PIN. The user does not have access to the Android system.Vscan Extend operating systemThe Vscan Extend is based on Android and Linux operating systems, but have been customized for Ultrasound use.Table 8-4: Operating systemFamily ProductVscan Extend DaVinci 6446 / 128MB / 64MB; Android 4.4.2/ 1.5 GB
Personal Information Collected by the ProductVscan Extend – User Manual 8-175721203-100 Rev. DPersonal Information Collected bythe ProductInformation collection and useThe Vscan Extend collects patient demographic information, personal and/or protected health information for the use within the system.Information entered for users defined in application user management is also stored on the system.The following types of information are collected for the purposes of patient medical diagnosis, user management, audit logging and/or debug logging:1. Patient demographics2. Medical diagnostics and measurements3. Ultrasound images4. Facility information5. Provider information6. Device dataPatient information collected is either entered manually by the user or is received through one or more of the system’s dataflows. Details on what data is collected, used and disclosed can be obtained by contacting GE Healthcare.
Privacy and Security8-18 Vscan Extend – User Manual5721203-100 Rev. DManual information collection Only PI required for the purpose of treatment or healthcare operations should be collected. The system supports collection of PI that is related for such usage only. However the system might support collection of more data than will be used for a particular installation. The user should limit the collect of PI to what is really needed.Only PI required for the purpose of treatment or healthcare operations should be collected. Even though the Vscan Extend supports PI collection for treatment or healthcare operaitons, the system might support collection of more data than is needed for a particular installation. Limit the PI collection to the content needed.The user should not enter personal identifiable information in free text fields on the system as this information is not anonymized by the de-identification procedure.
Personal Information Collected by the ProductVscan Extend – User Manual 8-195721203-100 Rev. DInformation disclosureIf the Vscan Extend is connected to external archives, patient demographics, medical diagnostics, measurements and ultrasound images will be communicated to/from the external archives. The same applies for remote network shares and external media, like a microSD card and USB cable used to export images to a PC. See ‘System interconnections’ on page 8-6 for more information.Retention and destruction of personal informationRetention and destruction of patient dataThe information collected is stored on the system until it is manually removed.Requirements and policies for limited collection and/or destruction of Patient Information on the system must be implemented by establishing appropriate procedures. There is no support for such functionality in the system.Retention and destruction of user information, local usersUser information created and managed on the device remains on the system until manually removed.Requirements and policies for limited collection and/or destruction of user information on the system must be implemented by establishing appropriate procedures. There is no support for such functionality in the system.
Privacy and Security8-20 Vscan Extend – User Manual5721203-100 Rev. DProtection of personal informationIndividuals authorization for collection, use and disclosure of PI/PHISome users of Vscan Extend system might face requirements and policies for letting individuals (the patients) authorize the collection, use and disclosure of PI/PHI. There is no support for such functionality in the system. Such requirements can only be implemented by operational procedures.Information to individuals of collection, use and disclosure of PI/PHISome users of the Vscan Extend may have certain requirements and policies to inform individuals (patients) about the collection, use and disclosure of PI/PHI. There is no support for such functionality in the system. Such requirements can only be implemented by procedures.
Personal Information Collected by the ProductVscan Extend – User Manual 8-215721203-100 Rev. DPotential Hazardous Situations Resulting From Failures of the IT NetworkHazardous situationsThe following situations have been identified as potentially hazardous as a result of the IT network failing to provide the required characteristics specified above.1. Delayed or impaired access to images or other exam information or patient data.2. Permanent loss of images or other exam information or patient data.3. Corruption of images or other exam information or patient data.WarningIn addition to the hazardous situations identified above, connection of the Vscan Extend to a network that includes other equipment could result in other unidentified risks to patients, operators or third parties. The responsible organization should identify, analyze, evaluate and control these risks on an ongoing basis. Re-evaluate the risks if any of the following occurs:1. Changes in network configuration2. Connection of additional items to the network3. Disconnecting items from the network4. Update of equipment connected to the network5. Upgrade of equipment connected to the network
Privacy and Security8-22 Vscan Extend – User Manual5721203-100 Rev. D
Vscan Extend – User Manual Index-15721203-100 Rev. DIndexAActivating Wi Fi, 4-21Appendix, 7-1Audit logsaudit logs, 5-30Auto freeze, 5-23AutoCycle, 5-23BBatteryCharge, 3-15Level indicator, 3-19Removing / inserting the battery (VE-BAT), 3-20specifications, 3-21Black and white imaging, 5-17Bladder VolumeBladder Volume, 5-47CCertificate Authority, 4-28Cleaning and disinfection, 6-4Color Aliasing, 5-22Color imaging (option), 5-20Configuring Wi Fi, 4-23DData exportdata export, 5-30Deletion of data, 5-28DICOMDICOM, 5-36EExternal battery charging compartment (option), 3-11IIndication for use, 1-4, 1-5InformationRequesting, 1-10Inspection, 6-3LLung ProtocolLung Protocol, 5-54MMeasurements, 5-24PPackage contents, 3-2Patient examination, 5-7Power on/off, 3-22Preparing Vscan ExtendTM for Use, 3-1Probe and Presets, 5-12RRegulatory Requirements, i-3Review and recall of stored data, 5-26SSafetyAcoustic output, 2-19Device labels and symbols, 2-25Electrical Hazard, 2-7Electrical hazard, 2-8Electromagnetic Compatibility (EMC), 2-10Explosion hazard, 2-7Maximum probe temperature, 2-24Mechanical hazards, 2-6Pacemaker hazard, 2-8Patient Safety, 2-5Personnel and equipment safety, 2-7Scanning, 5-2Settings, 4-2System description, 3-4TTricefy, 5-62Troubleshooting, 6-14UUpgrade application software, 6-12USB export
Index-2 Vscan Extend – User Manual5721203-100 Rev. DUSB export, 5-31Using Vscan Extend, 5-1VVoltage requirements, 3-17Vscan Extend Battery, 3-15Vscan Extend Maintenance, 6-1Vscan Extend Settings, 4-1

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