Technical Publications Vscan Extend™ Version 1.0 User Manual 5721203-100 — English Rev. D Operating Documentation Copyright © 2016 By General Electric Co.
Regulatory requirement This product complies with regulatory requirements of the following European Directive 93/42/EEC concerning medical devices. This manual is a reference for the Vscan Extend. It applies to all versions of the 1.0 software for the Vscan Extend ultrasound system. Manufacturer: GE VINGMED ULTRASOUND A/S Strandpromenaden 45 3191 Horten, Norway Tel.
Revision History Reason for Change REV DATE (YYYY/MM/DD) REASON FOR CHANGE Rev. A 2016/04/05 Initial draft Rev. B 2016/05/19 Included External Battery charger label Included Power button under device labels Included revised rating label Included sections in Privacy and Security chapter Rev. C 2016/06/01 Removed breast and testes from indication of use statement Included the revised rating label, battery label and external charger label Included the scope for all the standards in Table i-1 Rev.
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Regulatory Requirements Conformance Standards The GE product families are tested to meet all applicable requirements in relevant EU Directives and European/ International standards. Any changes to accessories, peripheral units or any other part of the system must be approved by the manufacturer: GE Medical Systems. Ignoring this advice may compromise the regulatory approvals obtained for the product.
Table i-1: Standard/Directive Regulatory Requirements (Continued) Scope ISO10993-1 Biological evaluation of medical devices EN 300 328 Electromagnetic compatibility and Radio spectrum Matters (ERM); Wideband transmission systems ISO 14971 Medical devices - Application of risk management to medical devices IEC* 62304 Medical device software - Software life-cycle processes IEC* 62366 Medical devices - Application of usability engineering to medical devices IEC* 60601-1-11 Requirements for medical
Classifications The following classifications are in accordance with the IEC/ EN 60601-1. Type and degree of protection against electric shock: • Vscan Extend has an internal battery which allows the operation during AC power absence. • The AC adapter is Class II. • Vscan Extend has type 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.
Country Specific Approval • USA AND TERRITORIES The following optional feature IS NOT available in the USA and its territories: DANGER – Ophthalmalic • JAPAN The following optional feature IS NOT available in JAPAN: DANGER – Ophthalmalic • CHINA The following optional feature IS NOT available in CHINA: DANGER – Ophthalmalic Importer Information Turkey i-6 Vscan Extend – User Manual 5721203-100 Rev.
Table of Contents Conformance Standards - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-3 Certifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-4 Classifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-5 Class II Equipment - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-5 Type BF Applied part - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
General precautionary advice for the use of diagnostic ultrasound in combination with ultrasound contrast agents - - - - - - - - - - - - - - - - - 2-6 Mechanical hazards - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-6 Electrical hazard - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-7 Personnel and equipment safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-7 Explosion hazard - - - - - - - - - - - - - - - - - - - - - - - - - - -
Chapter 5 — Using Vscan Extend Scanning General scanning recommendations- - - - - - - - - - - - - - - - - - - - - - - - - - 5-2 Black and white imaging - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-17 Color imaging - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-20 Auto freeze - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-23 AutoCycle - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Chapter 8 — Privacy and Security Introduction Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-2 How to contact GE - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-2 Privacy and Security Environment - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-3 Network Connectivity Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - System interconnections - - - - - - - - - - - - - - - -
Chapter 1 Introduction Contents: ‘Overview’ on page 1-2 ‘Warnings’ on page 1-7 ‘Contact Information’ on page 1-10 Vscan Extend – User Manual 5721203-100 Rev.
Introduction Overview Attention This 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.
Overview Principles of operation Medical ultrasound images are created by computer and digital memory from the transmission and reception of mechanical high-frequency waves applied through a probe. The mechanical ultrasound waves spread through the body, producing an echo where density changes occur. The echoes return to the probe where they are converted back into electrical signals.
Introduction Indications for use (for all countries except USA, China and Japan) Vscan Extend is a general purpose diagnostic ultrasound imaging system for use by qualified and trained healthcare professionals enabling visualization and measurement of anatomical structures and fluid. It's pocket-sized portability and simplified user interface enables integration into examination and training sessions indoors and in other environments described in the user manual.
Overview Indications 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.
Introduction Intended users Vscan Extend is intended to be used by qualified and trained healthcare professionals that are legally authorized by law in the country, state or other local municipality in which he practices to use the device.
Warnings Warnings Important Safety Considerations To 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.
Introduction Important Safety Considerations (continued) WARNING • Do not short-circuit the battery terminal with metallic objects. This may result in overheating and burns. • Do not store or carry a battery loosely with metallic devices. • Disconnect the battery charger when not in use to avoid fire hazard. • Keep the charger dry. Failure to observe this precaution may result in fire and electric shock • Keep this unit out of reach of children.
Warnings Important 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: CAUTION CAUTION • Do not charge or use the battery if it appears to be damaged or leaking.
Introduction Contact Information Contacting GE Ultrasound For additional information or assistance, please contact your local distributor or the appropriate support resource listed on the following pages: Internet https://vscan.gehealthcare.com http://www.gehealthcare.com USA TEL: (1) 800-437-1171 Ultrasound Service Engineering 9900 Innovation Drive Wauwatosa, WI 53226 Clinical Questions Please contact your local Applications or Sales Representative.
Contact Information Accessories Catalog Requests To request the latest GE Accessories catalog or equipment brochures in the United States, call the Response Center TEL: (1) 800-643-6439 In other locations, contact your local Applications, Sales or Service Representative.
Introduction Europe, Middle East and Africa Table 1-2: Europe, Middle East and Africa Region Telephone Algeria +21321484612 Andorra 902 400 246 Austria 0800244260 Belgium Dutch +32 262 638 38 Belgium French +32 262 638 39 Bulgarian +35929712040 Denmark 80404944 Egypt +202 19434 [hot line] Finland 0981710182 France 0800139140 G. D.
Contact Information Table 1-2: Europe, Middle East and Africa (Continued) Region Telephone Saudi Arabia 800 1243002 South Africa 800 111 671 Spain 902 400 246 Sweden 0201201436 Switzerland 0800556958 Turkey Contact local distributor UAE 800 3646 UK 0845 8503392 Ukraine +38 044 391 37 56 (57) Vscan Extend – User Manual 5721203-100 Rev.
Introduction Asia and Pacific Table 1-3: Asia and Pacific Region Telephone China 8008108188 Hong Kong (852) 21006288 Taiwan 0800-021-770 India (91) 1800-425-8025 Singapore (65) 62773444 Australia 1-800-659-465 New Zealand 0800 65 94 65 Japan 0120-055-919 Korea (82) 2-1544-6119 Bangladesh (880) 29135488 Sri Lanka (94) 114891178 Bhutan Contact GE India Maldives Contact GE India Nepal Contact local distributor Malaysia 1800 88 3911 Thailand (66) 26248400 Vietnam Contact loc
Chapter 2 Safety Contents: ‘Introduction’ on page 2-2 ‘Owner responsibility’ on page 2-3 ‘Important safety considerations’ on page 2-5 ‘Maximum probe temperature’ on page 2-24 ‘Device labels and symbols’ on page 2-25 Vscan Extend – User Manual 5721203-100 Rev.
Safety Introduction Overview This chapter describes the important safety measures which should be taken before operating the Vscan Extend. Procedures for simple care and maintenance of the Vscan Extend are also described. Various levels of safety precautions may be found on the equipment, and different levels of severity are identified by one of the following icons that precede precautionary statements in the text.
Owner responsibility Owner responsibility Overview It is the responsibility of the owner to ensure that anyone operating Vscan Extend reads and understands this section of the manual. However, there is no representation that the act of reading this manual renders the reader qualified to operate, inspect, test, align, calibrate, troubleshoot, repair or modify the system. The owner should make certain that only properly trained, fully-qualified service personnel undertake maintenance of the equipment.
Safety Overview (continued) The owner of Vscan Extend MUST be aware of the data protection policies while configuring the DICOM and Windows Share servers. GE is not responsible for data sharing. Before configuring the servers, the owner of the Vscan Extend MUST abide by the applicable privacy acts specific to their region or country. CAUTION For USA only: Federal law restricts this device to sale by or on the order of a physician. CAUTION Vscan Extend should be used in compliance with law.
Important safety considerations Important safety considerations Overview This section includes considerations for the following: • Patient safety • Personnel and equipment safety The information contained in this section is intended to familiarize the user with the hazards associated with the use of Vscan Extend, and to alert them to the extent to which injury and damage may occur if the precautions are not observed.
Safety Diagnostic information The images and calculations provided by the system, including bladder volume and lung protocol, are intended for use by competent users, as a diagnostic tool. They are not to be explicitly regarded as the sole, irrefutable basis for clinical diagnosis. Users are encouraged to study the literature and reach their own professional conclusions regarding the clinical use of the system.
Important safety considerations Electrical hazard A damaged probe may increase the risk of electric shock if conductive solutions come in contact with internal electronics. Inspect the probe often for cracks or openings in the housing and holes in and around the acoustic lens, or other 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.
Safety Electrical hazard WARNING NOTE: The internal circuits of the AC/DC adapter use high voltages, capable of causing serious injury or death by electrical shock. 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.
Important safety considerations External Connection 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). Figure 2-1. Patient environment 1.
Safety Electromagnetic Compatibility (EMC) NOTE: This unit carries the CE mark. It complies with regulatory requirements of the European Directive 93/42/EEC concerning medical devices. It also complies with emission limits for a Group 1, Class B Medical Device as stated in EN/ IEC 60601-1-2. Electrical medical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this manual.
Important safety considerations Electromagnetic Compatibility (EMC) (continued) Devices which intrinsically transmit radio waves such as cellular phones, radio transceivers, mobile radio transmitters, radio-controlled toys, and so on, should preferably not be operated near the unit. See ‘Electromagnetic Compatibility (EMC)’ on page 2-10 about the recommended minimum separation distances between portable and mobile RF communications equipment and the ultrasound unit.
Safety FCC compliance statements (continued) This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation.
Important safety considerations FCC 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 radiofréquences définies par Industrie Canada pourun environnement non contrôlé.
Safety Electromagnetic emissions Table 2-1: Electromagnetic emissions Guidance and manufacturer’s declaration – electromagnetic emissions. Emissions test Compliance Electromagnetic environment - guidance RF emission EN55011 Group 1 Class B The Vscan Extend uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
Important safety considerations Table 2-2: Electromagnetic immunity (Part 1) (Continued) Guidance and manufacturer’s declaration – electromagnetic immunity. The Vscan Extend is intended for use in the electromagnetic environment below. The customer or the user of the Vscan Extend should assure that it is used in such an environment.
Safety Electromagnetic 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-supporting The Vscan Extend is intended for use in the electromagnetic environment below. The customer or the user of the Vscan Extend should assure that it is used in such an environment.
Important safety considerations 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-supporting The Vscan Extend is intended for use in the electromagnetic environment below. The customer or the user of the Vscan Extend should assure that it is used in such an environment.
Safety Separation distances Table 2-4: Separation distances Recommended separation distances between portable and mobile RF communications equipment and the ultrasound unit The ultrasound unit is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
Important safety considerations Acoustic output Definition of the acoustic output parameters Thermal Index TI is an estimate of the temperature increase of soft tissue or bone. There are three thermal index categories: • TIS: Soft tissue thermal index. The main TI category. Used for applications that do not image bone. • TIB: Bone thermal index (bone located in a focal region). Used for fetal application. • TIC: Cranial bone thermal index (bone located close to the surface).
Safety Acoustic output and display on Vscan Extend MI and TI values are displayed on the scanning screen. The maximum possible MI and Ispta on the Vscan Extend is within the limits set in Track 3 in the FDA guidance of September 9, 2008 for diagnostic ultrasound systems and transducers, MI <1.9 and Ispta <720 mW/cm2. Display Accuracy and Acoustic Measurement Uncertainties The display accuracy and measurement precision of the output display are summarized in the table below.
Important safety considerations System controls affecting acoustic output The operator controls that directly affect the acoustic output are discussed in the Acoustic Output Data Tables (See ‘Acoustic Output Reporting Tables’ on page 7-3 for more information.). These tables show the highest possible acoustic intensity for a given mode, obtainable only when the maximum combination of control settings is selected. Most settings result in a much lower output.
Safety Application selection Selecting 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 modes Acoustic output depends on the imaging mode selected.
Important safety considerations ALARA (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: AIUM 14750 Sweitzer Lane Suite 100 Laurel, MD, USA 20707-5906 In addition, the sections ‘Acoustic output and display on Vscan Extend’ on page 2-20 and ‘System controls affecting acoustic output’ on page 2-21 should be studied carefully in order to implement ALARA.
Safety Maximum probe temperature The table below indicates the maximum probe temperature. Table 2-7: Maximum probe temperature Max Temp in deg C (Simulated use) Probe Max Temp in deg C (Still air) Vscan Extend – configured with Sector probe: Phased array transducer (G3S) for Deep scanning 39.7 43.1 Vscan Extend – configured with Dual probe: Phased array transducer (G3S) for Deep scanning 41 42.
Device labels and symbols Device labels and symbols Vscan Extend Labels (Example) Figure 2-2. 1. 2. 3. 4. NOTE: Vscan Extend rating label Rating label Inner label UDI label - contains UDI information Serial number label - contains device serial number The label shown in Figure 2-2 is a sample. The label varies country to country based on country requirements. Vscan Extend – User Manual 5721203-100 Rev.
Safety Vscan Extend Labels (Example) (continued) Figure 2-3. Figure 2-4. Figure 2-5. 2-26 Vscan Extend battery label Vscan Extend AC/DC adapter label Vscan Extend external battery charger label Vscan Extend – User Manual 5721203-100 Rev.
Device labels and symbols Vscan Extend Labels (Example) (continued) The following table describes the purpose of safety labels and other important information provided on the equipment. Table 2-8: Label Label Icons Purpose Location CE mark • Vscan Extend system • Vscan Extend External Battery charger This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately.
Safety Table 2-8: Label Assembled in Romania (Romania is a country name) NOTE: 2-28 Label Icons (Continued) Purpose Location Manufacturer name and address • Vscan Extend system • Vscan Extend External Battery charger Manufacturing date (year-month) • Vscan Extend system • Vscan Extend External Battery charger Part number • Vscan Extend system • Vscan Extend External Battery charger Serial number • Vscan Extend system • Vscan Extend External Battery charger Unique Device Identification (UDI).
Device labels and symbols Explanation of the Pollution control label for China The following product pollution control information is provided according to SJ/T11364-2014 Marking for Restriction of Hazardous Substances caused by electrical and electronic products Table 2-9: Label for China Label Description This symbol indicates the product contains hazardous materials in excess of the limits established by the Chinese standard GB/T 26572 Requirements of concentration limits for certain restricted substa
Safety 2-30 Vscan Extend – User Manual 5721203-100 Rev.
Chapter 3 Preparing Vscan Extend for Use Contents: ‘Package contents’ on page 3-2 ‘System description’ on page 3-4 ‘Battery’ on page 3-15 ‘First time use’ on page 3-22 ‘Activation’ on page 3-24 Vscan Extend – User Manual 5721203-100 Rev.
Preparing Vscan Extend for Use Package contents Vscan Extend package contents Make sure all items listed below are included in the package. Figure 3-1. Vscan Extend package contents 1. Vscan Extend softcase with device and probe 2. USB cable 3. Gel bottle location Table 3-1: Item 4. Region-specific plugs 5. AC/DC adapter 6. Battery Package content Description Vscan Extend Quick Card Vscan Extend User Manual Service contact information 3-2 Vscan Extend – User Manual 5721203-100 Rev.
Environmental requirements Environmental requirements Environmental requirements for the device Description Table 3-2: Environmental requirements Operational Non operational Storage and transport Temperature 0 °C to + 40 °C - 40 °C to + 70 °C - 40 °C to + 70 °C Humidity 90%, non-condensing 15–90% 90%, non-condensing Air pressure 620 hPa to 1060 hPa 620 hPa to 1060 hPa 620 hPa to 1060 hPa Transient operating conditions NOTE: NOTE: Permissible transient environmental operating conditions
Preparing Vscan Extend for Use System description System overview Vscan Extend configured with a Sector probe for deep scanning Figure 3-2. 1. Display 2. Sector probe 3. Serial port (For Service ONLY) NOTE: 3-4 Vscan Extend with a Sector probe 4. Power button 5. LED indicates charging status 6. USB port and Power connector Green LED indicates Vscan Extend is fully charged and an amber LED indicates it is charging. Vscan Extend – User Manual 5721203-100 Rev.
System description Vscan Extend configured with a Dual probe holding both a phased array and linear array transducer for deep and shallow scanning Figure 3-3. 1. Display 2. Dual probe 3. Serial port (For Service ONLY) NOTE: Vscan Extend with Dual probe 4. Power button 5. LED indicates charging status 6. USB port and Power connector Green LED indicates Vscan Extend is fully charged and an amber LED indicates it is charging. Vscan Extend – User Manual 5721203-100 Rev.
Preparing Vscan Extend for Use Vscan Extend Dual Probe Figure 3-4. The dual probe 1. Phased array transducer (deep scanning) 2. Linear array transducer (shallow scanning) 3-6 Vscan Extend – User Manual 5721203-100 Rev.
System description Accessories and Configurations Standard and optional accessories Table 3-3: Standard accessories Accessory Figure 1. Global AC adapter with interchangeable region-specific plugs 2. One rechargeable battery 3. USB cable 4. MicroSD memory card (For service personnel only. Not for customer use.*) 5. Soft case 6. User Manual 7. Hardcopy Quick Card * The microSD card provided in the device captures error logs and is strictly for Service personnel only.
Preparing Vscan Extend for Use Table 3-3: Standard accessories Accessory Figure ** 8. Gel (60g bottle) * 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 3-8 Vscan Extend – User Manual 5721203-100 Rev.
System description Standard and optional accessories (continued) Table 3-4: Optional accessories Accessory Figure 1. Additional Soft case 2. Robust case to carry complete Vscan Extend set 3. Robust case to carry only scanner, gel, and potential extra battery 4. External Battery charger 5. Additional Battery 6. Additional AC adapter 7. Hardcopy User manual Vscan Extend – User Manual 5721203-100 Rev.
Preparing Vscan Extend for Use Connectivity Configurations Vscan Extend is available in three different connectivity configurations: 1. USB configuration 2. Wi-Fi Access configuration 3. DICOM configuration The table below describes the standard and connectivity configurations.
System description External battery charger compartment (option) The external battery charger compartment is used to charge the battery outside the Vscan Extend. NOTE: The Vscan Extend battery can either be charged in the main 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.
Preparing Vscan Extend for Use Display screens Figure 3-6. Scanning screens (Black and white mode) Phased array transducer 1. Header • Menu icon • Patient information • Exam number • Battery level indicator • MI and TI values 2. Depth scale 3. Footer • Color icon • Gain • Depth • Store NOTE: 3-12 Linear array transducer 1. Header • Menu icon • Patient information • Exam number • Battery level indicator • MI and TI values 2. Depth scale 3.
System description Display 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 values 2. Depth scale 3. Footer • Color icon • Gain • Depth • Store 4. Color bar 5. Color ROI (Region of Interest) Vscan Extend – User Manual 5721203-100 Rev. D Linear array transducer 1. Header • Menu icon • Patient information • Exam number • Battery level indicator • MI and TI values 2.
Preparing Vscan Extend for Use Display screens (continued) Figure 3-8. 3-14 Menu screen Vscan Extend – User Manual 5721203-100 Rev.
Vscan Extend Battery Vscan Extend Battery Battery The Vscan Extend system is powered by a Li ION battery (Model - U80395). The battery is not fully charged prior to shipment. To maximize time of use, it is recommended to recharge the battery before use for at least 1.5 hours. Establish a routine for charging the battery to maximize system availability. The battery must be charged while housed in the Vscan Extend or in the external battery charger.
Preparing Vscan Extend for Use Battery (continued) WARNING Use only the AC adapter provided with the Vscan Extend. The Vscan Extend cannot be charged via the USB cable when connected to a PC. Figure 3-10. CAUTION Vscan Extend AC adapter The AC adapter must be kept outside the patient environment (refer to local regulation and EN 60601-1). Figure 3-11. Patient environment 1. Patient environment WARNING 3-16 Do NOT simultaneously touch the patient and the charger plug on the AC adapter.
Vscan Extend Battery Power plugs 1. Select the country specific plug. Figure 3-12. Power plugs 1. North America, Japan 2. China 3. Australia, New Zealand 4. UK, Hong Kong, Singapore 5. Continental Europe and Korea (for unearthed electrical outlet) 2. Insert the relevant plug into the adapter. Figure 3-13. Insert the plug Voltage requirements The AC/DC adapter will function on voltage from 100 to 240 VAC and 50/60 Hz. CAUTION Only use mains power of 100 – 240 VAC.
Preparing Vscan Extend for Use Charging the battery 1. Insert the battery into the device. Figure 3-14. Insert the battery 2. Plug the AC/DC adapter into the electrical outlet. Charging the battery using the optional External battery charger compartment 1. Place the external battery charger on a flat 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.
Vscan Extend Battery Battery level indicator The battery level indicator is displayed on the screen. The following icons are displayed. Table 3-8: Battery level indicator Icon Description Battery fully charged (>=95%). Battery 75% charged (>=70% and <95%). Battery 50% charged (>=45% and <70%). Battery critical, or low Battery (<45%). Prepare to recharge the battery or have a spare battery available. Battery charging. Vscan Extend – User Manual 5721203-100 Rev.
Preparing Vscan Extend for Use Inserting/removing the battery To insert the battery 1. Insert the battery in the compartment until the lid clicks in place. Figure 3-15. Inserting battery To remove the battery 1. Power off the Vscan Extend. CAUTION Do not attempt to remove the battery without powering off the Vscan Extend. 2. Push the button on the battery compartment lid and lift the battery. Figure 3-16. 3-20 Removing battery Vscan Extend – User Manual 5721203-100 Rev.
Vscan Extend Battery Battery specifications Table 3-9: Battery specification Item Specification Charging time at 90% About 75 minutes Capacity About 1 hour while continuously scanning Lifetime At least 300 charges In order to get maximum charging capacity with your Vscan Extend battery, you should initially allow the battery to be fully charged and then fully discharged at least three times. Perform normal operation during these cycles.
Preparing Vscan Extend for Use Initial use First time use Before Vscan Extend can be used, the following steps must be done: 1. Install the battery. (See ‘To insert the battery’ on page 3-20 for more information.) 2. Press the Power button to power on Vscan Extend. 3. Activate Vscan Extend. (See ‘Vscan Extend activation’ on page 3-24 for more information.) Power on/off To power on the Vscan Extend Press the Power button. Device boots up and scan screen displays within 45 seconds.
Initial use To restart Vscan Extend 1. Press and hold the Power button. 2. Select Restart to restart the device. Standby Mode Vscan Extend enters standby mode when the Power button is quickly pushed. In this mode, Vscan Extend will not have power to the probe or any display. OR Vscan Extend enters standby mode automatically while in freeze mode for more than 10 minutes. Push the Power button again once to resume from standby mode. The device is ready to scan within a second.
Preparing Vscan Extend for Use Vscan Extend activation Activation There are three possible scenarios to activate Vscan Extend: 1. Scenario 1: Activation using Wi-Fi on the Vscan Extend device. 2. Scenario 2: Manual activation - activate Vscan Extend by visiting the url: https://vscanactive.gehealthcare.com from a PC. 3. Scenario 3: Activation without internet access.
Initial use Set Language, Date and Time 1. Connect Vscan Extend to a power source. 2. Press the Power button to power on Vscan Extend. The Startup screen displays, followed by the Language screen. NOTE: The default language is set to English. 3. To choose another language, press Change Language. Figure 3-17. Select language 4. Choose the desired language. The screen changes back to the Language screen. 5. Press Next. Vscan Extend – User Manual 5721203-100 Rev.
Preparing Vscan Extend for Use Set Language, Date and Time (continued) 6. The Date and Time screen displays. NOTE: The current date and time is set by default. 7. Press Change Date and Time to change the date and time, if needed. Figure 3-18. Date and Time Choose either the automatic date and time format which sets the date and time by synchronizing through the internet. OR Set the date and time manually. 8. Press Next. 3-26 Vscan Extend – User Manual 5721203-100 Rev.
Initial use Connecting Wi-Fi NOTE: 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 settings 2. Press Next. NOTE: Ensure that the Vscan Extend is connected to a non-clinical Wi-Fi hotspot to start activation. NOTE: A non-clinical Wi-Fi has access to the public internet, which is not part of the hospital internet.
Preparing Vscan Extend for Use Connecting Wi-Fi (continued) 1. Enter the authentication details to connect to the network. Figure 3-20. Authentication code 2. Once the device connects to the network, press the Back arrow to exit the Settings screen. The screen changes back to the Wi-Fi screen (Figure 3-19 on page 3-27.) 3. Press Next. 3-28 Vscan Extend – User Manual 5721203-100 Rev.
Initial use Registration Registering the device creates a Vscan Extend account which enables access to the GE Marketplace and other features. First time registrants 1. First time registrants, press Register to create an account. Enter the required details. Figure 3-21. NOTE: HINTS Registration details 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.
Preparing Vscan Extend for Use First time registrants (continued) 2. Check the desired options to either participate in collaborative GE activities or to receive special offers and promotions. Press Register. 3. An email is sent to the email address used during registration. NOTE: The email has a link requiring you to change your password for security purposes. 4. Press Activate my device. Figure 3-23. Choose an option 5. Vscan Extend has been activated. Press Start Using Device. Figure 3-24.
Initial use Registered users NOTE: 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. NOTE: Already Registered 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. Vscan Extend – User Manual 5721203-100 Rev.
Preparing Vscan Extend for Use Registered users (continued) 3. While the activation process is in progress, the wireless is connecting to the GE Store and the activation key is being entered automatically. 4. Press Activate my device. 5. Vscan Extend has been activated. Start using the device. Figure 3-26. 3-32 Start using Vscan Extend Vscan Extend – User Manual 5721203-100 Rev.
Initial use Already registered users - Forgot password 1. If you forgot your password, press Forgot Password. 2. An email is sent to your confirmed email address with a link to reset the password. Figure 3-27. Forgot password 3. Click on the link on a personal computer to reset the password. 4. Enter your email ID and new password. The Vscan Extend is activated and ready to use. Figure 3-28. Reset password and start using Vscan Extend Vscan Extend – User Manual 5721203-100 Rev.
Preparing Vscan Extend for Use Network access failed 1. If you are unable to connect to a Wi-Fi network, press Retry and try to activate the device again. Figure 3-29. Retry 2. If the problem persists, contact your internet service provider and GE at help@gehc.com to connect to the network. 3. If the network is not accessible or you are unable to connect to the network, you can activate Vscan Extend manually. See ‘Manual activation’ on page 3-35 for more information.
Initial use Manual activation To activate Vscan Extend without Wi-Fi connection, follow the steps below. 1. Open the URL (https://vscanactive.gehealthcare.com) in the internet browser on your PC. 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.
Preparing Vscan Extend for Use Manual activation (continued) 5. Press Submit to initiate registration. Figure 3-33. Submit 6. The Activation key is generated. Store the key in a convenient location to enter into the device and for future reference. Figure 3-34. 3-36 Activation key details Vscan Extend – User Manual 5721203-100 Rev.
Initial use Activation key The Activation key screen is displayed on the Vscan Extend. 1. Enter the activation key generated while registering on the portal (https://vscanactive.gehealthcare.com) Figure 3-35. HINTS Enter activation key Press the Backspace key if a mistake occurred while entering the activation key. 2. Press Activate. Figure 3-36. Start using the device 3. Vscan Extend has been activated. Start using the device. Vscan Extend – User Manual 5721203-100 Rev.
Preparing Vscan Extend for Use 3-38 Vscan Extend – User Manual 5721203-100 Rev.
Chapter 4 Vscan Extend Settings Contents: ‘Settings’ on page 4-2 ‘Scan Settings’ on page 4-2 ‘Server Settings’ on page 4-3 ‘Diagnostics’ on page 4-12 ‘Wi-Fi’ on page 4-21 ‘MDM Installation Procedures (Optional)’ on page 4-24 ‘Certificate Authority’ on page 4-28 ‘GE Marketplace’ on page 4-31 Vscan Extend – User Manual 5721203-100 Rev.
Vscan Extend Settings Settings The following settings and functions are available under the main Settings menu. Scan Settings Press Menu -> Settings Figure 4-1. • Settings Brightness - adjusts the screen brightness of the device Swipe the brightness level indicator to the left to decrease the brightness and swipe to the right to increase the brightness. 4-2 Vscan Extend – User Manual 5721203-100 Rev.
Settings Scan Settings (continued) Auto Freeze (Probe) - set the auto freeze time. 1. Press Auto Freeze (Probe) 2. Choose the desired value 3. Press OK to set the value Video Duration - set duration of the captured Cine loops. 1. Press Video Duration 2. Choose the desired value 3. Press OK to set the value Unit of Measurement - set unit of measurement 1. Press Unit of Measurement 2. Choose the desired unit 3. Press OK to set the value Set current preset as default 1. Press Set Current Preset as Default 2.
Vscan Extend Settings Server Settings (continued) To configure the Worklist server: HINTS Press the title bar (the entire top section on the screen) or swipe left most side of the screen to access the Menu. 1. Press Menu -> Settings Figure 4-3. Settings 2. Scroll down to Server Settings. Press Worklist Server. Figure 4-4. 4-4 Worklist server Vscan Extend – User Manual 5721203-100 Rev.
Settings Configure Worklist Server Connect Vscan Extend to the hospital wireless network. See ‘Activation using Wi-Fi’ on page 3-24 for more information. 1. Enter all fields to add a new Worklist server. Figure 4-5. NOTE: Configure Worklist Server Swipe upwards to get the full screen and enter all details. Contact the hospital IT administrator for details. Vscan Extend – User Manual 5721203-100 Rev.
Vscan Extend Settings Configure Worklist Server (continued) NOTE: By default, DICOM is listed while configuring the Worklist Server. Figure 4-6. DICOM listed 2. Enter any unique name for Calling AE Title (e.g. Nixon Building Schedule). 3. Press Add Server to add the Worklist Server. 4. Press Verify to verify communication with the Worklist Server. Figure 4-7. 4-6 Verify Worklist Server Vscan Extend – User Manual 5721203-100 Rev.
Settings Configure 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.
Vscan Extend Settings Configure Worklist Server (continued) 6. To add another Worklist server, press Add (+). Figure 4-9. Add another Worklist server 7. To delete the Worklist Server, press the Delete icon. Figure 4-10. 4-8 Delete Worklist Vscan Extend – User Manual 5721203-100 Rev.
Settings Configure Image Server 1. Press Menu -> Settings Figure 4-11. Menu 2. Scroll down to Server Settings. Press Image Server. Figure 4-12. Vscan Extend – User Manual 5721203-100 Rev.
Vscan Extend Settings Configure Image Server (continued) 3. Enter your Image server’s IP address, port number, and Remote AE Title. Figure 4-13. NOTE: Configure Image Server 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. 4-10 Vscan Extend – User Manual 5721203-100 Rev.
Settings Configure 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 – User Manual 5721203-100 Rev.
Vscan Extend Settings Configure Image Server (continued) 6. Press and hold the Image Server to add the selected Image Server to favorites. Figure 4-15. NOTE: Add to favorites 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. Diagnostics Figure 4-16.
Settings System Settings Figure 4-17. WARNING 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.
Vscan Extend Settings System 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. Configuration Press View Modules to obtain the list of enabled modules. Figure 4-19. 4-14 Enabled modules • My Account - Set User account • About - Provides device information Vscan Extend – User Manual 5721203-100 Rev.
Settings Administrator Access For 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 PIN 2. Enter the new PIN again for confirmation. Figure 4-21. NOTE: Confirm new PIN 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 – User Manual 5721203-100 Rev.
Vscan Extend Settings Administrator Access (continued) The new PIN provides access to advanced settings. Figure 4-22. 4-16 Advanced Settings Vscan Extend – User Manual 5721203-100 Rev.
Settings Storage Access A 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 PIN 2. Confirm the new PIN for security purpose.
Vscan Extend Settings Storage 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 PIN The new PIN provides access to data storage and retrieval during normal use of the Vscan Extend.
Settings Incorrect PIN (continued) 1. A pop-up message displays when an incorrect PIN is entered. Figure 4-26. Wrong PIN 2. 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. Vscan Extend – User Manual 5721203-100 Rev.
Vscan Extend Settings Incorrect 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. NOTE: Remaining attempts It is highly recommended to back up data on a microSD card before the last attempt.
Settings Wi-Fi Wi-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-Fi To activate Wi-Fi on the Vscan Extend: 1. Press Menu -> Settings -> Admin Settings. Figure 4-29. Admin Settings 2. 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 Settings Activating Wi-Fi (continued) 3. Press Settings on the Dashboard. Figure 4-30. 4-22 Advanced Settings Vscan Extend – User Manual 5721203-100 Rev.
Settings Configuring Wi-Fi 1. Press the ON/OFF button on the right to turn ON Wi-Fi. 2. Press Wi-Fi. Figure 4-31. Menu Choose the network if you know the credentials or contact your system administration Procedure to check the MAC Address NOTE: If the Wi-Fi network has been configured with the MAC address, press MAC Address on the Advanced Settings screen. Figure 4-32. Vscan Extend – User Manual 5721203-100 Rev.
Vscan Extend Settings Deleting Wi-Fi networks 1. 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.
Settings MDM Installation Procedures (Optional) (continued) 2. Install the correct MDM agent from Google Play (Airwatch, Mobile Iron). Figure 4-34. MDM 3. View the MDM service client with the help of your IT department. Figure 4-35. Vscan Extend – User Manual 5721203-100 Rev.
Vscan Extend Settings MDM 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 Settings 6. Press Admin Console App Chooser. Figure 4-37. 4-26 Admin Console App Chooser Vscan Extend – User Manual 5721203-100 Rev.
Settings MDM Installation Procedures (Optional) (continued) 7. Select the MDM Agent and press Update. Figure 4-38. Select MDM Agent Figure 4-39. Update The MDM agent is listed in the Dashboard. Vscan Extend – User Manual 5721203-100 Rev.
Vscan Extend Settings Certificate Authority Trusted 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.
Settings Certificate Authority (continued) 2. Press Install certificate. Figure 4-41. Install certificate To 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 – User Manual 5721203-100 Rev.
Vscan Extend Settings Certificate 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 Certificate The certificate is successfully downloaded onto your Vscan Extend. You can now choose it while connecting to a certificate based Wi-Fi authentication. 4-30 Vscan Extend – User Manual 5721203-100 Rev.
Settings GE Marketplace Registered 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.
Vscan Extend Settings Installing Vscan Apps 1. Press GE Marketplace on the Settings screen. Figure 4-44. Figure 4-45. 4-32 GE Marketplace Connecting to GE Marketplace Vscan Extend – User Manual 5721203-100 Rev.
Settings Installing Vscan Apps (continued) 2. List of available Vscan apps are displayed. Figure 4-46. List of Vscan Apps 3. Select the App (for example, Bladder Volume). Press Install. Figure 4-47. Install app 4. The App gets downloaded and prompts you to install. Press Install. Vscan Extend – User Manual 5721203-100 Rev.
Vscan Extend Settings Updating the Marketplace On 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 Apps 1. Press Menu -> Settings -> GE Marketplace. Press the App to uninstall.
Settings Scenarios while trying to access GE Marketplace Email address not valid User 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. OR Enter a password matching the email to confirm your device. Figure 4-49. Resend confirmation email Enter a valid email address. A confirmation email is sent. On your PC, set the password.
Vscan Extend Settings Email address not confirmed User 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 email A message displays: This Vscan Extend device has been registered to your account. The user account details page displays. Figure 4-52. Account details Press the Back arrow and press GE Marketplace. 4-36 Vscan Extend – User Manual 5721203-100 Rev.
Chapter 5 Using Vscan Extend Contents: ‘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 Vscan Extend – User Manual 5721203-100 Rev.
Using Vscan Extend Scanning General scanning recommendations Before 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).
Scanning Use of gel In order to ensure optimal transmission of energy between the patient and the transducer, a conductive gel must be applied on the transducer lens. CAUTION If the gel comes in contact with the eye, consult the gel manufacturer's instructions. The following gels have been tested to be compatible with the Vscan Extend. Table 5-1: Compatible Gels Aquasonics 100 Parker Laboratory Inc. Clear Image Sonotech Inc. Scan Parker Laboratory Inc.
Using Vscan Extend Other recommendations Like 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.
Scanning Probe orientation The 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 orientation 1. Orientation marking on probe 2. Orientation marking on screen The dual probe is provided with an orientation mark and a green LED light.
Using Vscan Extend Probe orientation (continued) Figure 5-3. Dual probe: Orientation mark, linear array active 1. Orientation marking on probe 2. Green LED light 3. Orientation marking on screen 5-6 Vscan Extend – User Manual 5721203-100 Rev.
Scanning Patient examination Creating new exam A 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.
Using Vscan Extend Saving a new exam When 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 exam Patient information can be entered in two ways: • Edit Patient on the Menu screen • DICOM - Retrieve patient information from DICOM modality worklist 1. Press Menu -> Edit Patient. Figure 5-4. 5-8 Edit patient details Vscan Extend – User Manual 5721203-100 Rev.
Scanning Editing patient information for an exam (continued) 2. Enter patient details and press Save. Figure 5-5. Save patient details 3. 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.
Using Vscan Extend Search Patient A 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 patient 2. Press Search icon. Figure 5-7. 5-10 Search icon Vscan Extend – User Manual 5721203-100 Rev.
Scanning Search Patient (continued) 3. Type the patient name or patient ID in the search field NOTE: 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.
Using Vscan Extend Probe and Presets The following table indicates the imaging modes supported by the probes. Table 5-2: Probe Supported imaging modes Black and white imaging Color flow G3S Phased array X (Harmonic) X Dual probe (G3S phased array and G8L linear array) X (Harmonic for G3S phased array) X To ensure optimal image quality, the Vscan Extend has predefined scanning settings optimized for different applications (e.g. Cardiac, Abdominal).
Scanning Probe and Presets (continued) Table 5-4: Linear transducer in Dual Probe (shallow scanning) presets Linear transducer in Dual Probe (shallow scanning) Preset Optimized for Vascular • Veins • Arteries Soft tissue • Small organs • Pediatric (recommended minimum weight: 4 kg) • Musculoskeletal - including Long bone, Hip, Knee, Shoulder and Elbow Lung • Thoracic/Pleural motion • Fluid detection Adult Cephalic Various cephalic structures Ophthalmic* Ophthalmic * Ophthalmic is available as
Using Vscan Extend To change the preset and probe 1. Press Menu. 2. Press the ... on the Preset tab. Figure 5-9. Menu page 3. 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. 5-14 Change Preset Vscan Extend – User Manual 5721203-100 Rev.
Scanning Creating preset favorites Up 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 page 3. 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 favorites 1. Probe/Preset Availability 2. Preset Favorites (blue icon) Vscan Extend – User Manual 5721203-100 Rev.
Using Vscan Extend Creating preset favorites (continued) The Menu page displays the selected favorites. Figure 5-13. NOTE: Menu page 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). 5-16 Vscan Extend – User Manual 5721203-100 Rev.
Scanning Black and white imaging Black 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. NOTE: Black and white scan screen As a safety precaution, scanning is not possible when charging the battery. Vscan Extend – User Manual 5721203-100 Rev.
Using Vscan Extend Black and white imaging (continued) Black and white imaging adjustments The 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.
Scanning Black 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.
Using Vscan Extend Color imaging Color 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 scan A 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.
Scanning Color imaging (continued) 3. Press Gain to access the color gain control. Figure 5-18. Color gain Color gain amplifies the overall strength of echoes processed in the color area. Vscan Extend – User Manual 5721203-100 Rev.
Using Vscan Extend Color imaging Scanning Adjustments Color Aliasing If 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.
Scanning Auto freeze If 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. AutoCycle Vscan Extend does not include an ECG interface as often found on larger ultrasound systems intended for cardiovascular applications.
Using Vscan Extend Measurements Taking measurements Vscan 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.
Measurements Taking 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. 5. Add new measurement Press Delete to delete a single measurement. Vscan Extend – User Manual 5721203-100 Rev.
Using Vscan Extend Review and recall of stored data Backups Recommended During 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.
Review and recall of stored data Reviewing and recalling images or videos from an exam list (continued) Figure 5-22. NOTE: View stored images and videos Press on the image in the Exams screen. Use the right/left arrow to naviagte through the images/videos. Vscan Extend – User Manual 5721203-100 Rev.
Using Vscan Extend Deletion of data To delete a file You can delete images or videos individually or from an exam list. Deleting individual images or videos 1. 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 deleted 6. Press Delete to delete the images. OR 7. Press Cancel to cancel deletion. Figure 5-24.
Review and recall of stored data Delete images from an exam list 1. Press Menu. 2. Press Exams. 3. Select the exam from the list. Figure 5-25. Images to be deleted 4. Press Delete to delete the images. OR 5. Press Cancel to cancel deletion. Vscan Extend – User Manual 5721203-100 Rev.
Using Vscan Extend Data Export Data 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.
Review and recall of stored data USB Export Patient 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 ID Export files JPG 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: ....\Arc
Using Vscan Extend Windows Share Windows 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 share 2. 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.
Review and recall of stored data Share images 1. 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. Figure 5-28. Vscan Extend – User Manual 5721203-100 Rev.
Using Vscan Extend Share 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. 5-34 Transfer failed Vscan Extend – User Manual 5721203-100 Rev.
Review and recall of stored data Device Status To 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 started Figure 5-30. Vscan Extend – User Manual 5721203-100 Rev.
Using Vscan Extend DICOM NOTE: This feature is available with the DICOM configuration. Overview Vscan Extend supports the following DICOM functionality: • Verify. See ‘Configure Worklist Server’ on page 4-5 for more information. • Modality Worklist • Store DICOM users can use: 1. DICOM Modality Worklist: Retrieve patient information from DICOM modality worklist broker 2. Add patient identifying information to exam. • manually • selecting from modality worklist 3.
Review and recall of stored data DICOM Modality Worklist: Retrieve patient information from DICOM Modality Worklist broker Vscan 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.
Using Vscan Extend DICOM Modality Worklist: Retrieve patient information from DICOM Modality Worklist broker (continued) 2. Press Refresh to download Worklist entries. Figure 5-32. NOTE: 5-38 Refresh Worklist It is not be possible to change the following DICOM attributes received from worklist: Patient Name, Patient ID and Accession Number. Vscan Extend – User Manual 5721203-100 Rev.
Review and recall of stored data DICOM Store: exporting DICOM images from Vscan server Extend to DICOM image At 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 -> Exams Figure 5-33. Exams 2. Press the Export icon. Figure 5-34. Export NOTE: Individual images from an exam or an entire exam can be selected for export.
Using Vscan Extend DICOM 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 destination 4. Press Upload Selected to export the exam. Figure 5-36. Upload selected exam The selected exam(s) are exported to the DICOM server. 5-40 Vscan Extend – User Manual 5721203-100 Rev.
Review and recall of stored data DICOM 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.
Using Vscan Extend Backup It 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. WARNING 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 data Backup (continued) 5. A pop-up displays. Figure 5-39. Backup data message Press 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. Vscan Extend – User Manual 5721203-100 Rev.
Using Vscan Extend Backup (continued) If the backup process is unsuccessful, a failed message displays. Figure 5-41. NOTE: Backup failed 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.
Review and recall of stored data Restore CAUTION 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. NOTE: The restore operation does not restore backed up logs. 1. Power OFF the Vscan Extend. 2. Remove the Battery.
Using Vscan Extend Restore (continued) 5. A pop-up displays. Figure 5-43. Restore Confirmation Press 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 failed If the microSD card does not contain any patient details to restore, a pop-up displays. The system automatically shuts down. Figure 5-45.
Using Vscan Extend Apps Using Vscan Extend Apps Overview There are four Apps avaiable on the Vscan Extend: • Bladder Volume • Lung Protocol • Tricefy Uplink Bladder Volume The 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. Vscan Extend – User Manual 5721203-100 Rev.
Using Vscan Extend Installing the Bladder Volume application 1. Press Menu -> Settings -> GE Marketplace. Figure 5-46. GE Marketplace A 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. 5-48 Vscan Extend – User Manual 5721203-100 Rev.
Using Vscan Extend Apps Bladder Volume settings 1. Press App Settings from the Settings menu. A pop-up displays. Figure 5-47. Bladder Volume app settings 2. Press on the desired formula. Figure 5-48. • [0.7 x (D1 x D2 x D3)] • [0.52 x (D1 x D2 x D3)] Vscan Extend – User Manual 5721203-100 Rev.
Using Vscan Extend Using Bladder Volume To 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.
Using Vscan Extend Apps Using 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. Transverse 1. D1 - Longitudinal maximum length 2. D2 - AP diameter NOTE: The Transverse Measure screen is displayed by default. Vscan Extend – User Manual 5721203-100 Rev.
Using Vscan Extend Using 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 Frame The image, along with the measurement values and volume, displays. Figure 5-52. Measurement values 8. Press Store. 5-52 Vscan Extend – User Manual 5721203-100 Rev.
Using Vscan Extend Apps Using 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 button Exiting Bladder Volume 1. Press Close to exit the Bladder Volume App. Figure 5-54.
Using Vscan Extend Lung Protocol Lung Protocol application guides you through a step by step lung ultrasound exam. The application performs the following functions: 1. Automatic lung preset selection 2. Guides or helps assessing the stored images 3. Helps to calculate a total lung score 4. Generates a simple report at the end of the exam Installing the Lung Protocol application 1. Press Menu -> Settings -> GE Marketplace. A list of available apps displays. 2. Press Lung Protocol to view details. 3.
Using Vscan Extend Apps Lung Protocol settings (continued) The Settings screen displays. Figure 5-56. Settings The 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 segments Three different configurations are available for the number of segments. Press on the radio button to choose any one of the following: • 4x2 • 7x2 • 6x2 Vscan Extend – User Manual 5721203-100 Rev.
Using Vscan Extend Lung Protocol settings (continued) Types of Assessment Two types of assessment are available. Press on the radio button to choose the desired type of assessment. • Quantitative • Qualitative. Help mode Help 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.
Using Vscan Extend Apps Lung Protocol settings (continued) 3. Press the Back arrow to return to the Protocols screen. Figure 5-57. Back arrow 4. 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 Protocol 1. Press Menu. 2. Press Start a protocol. 3. Press Lung Protocol. Figure 5-58.
Using Vscan Extend Using 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 menu The scan screen displays. Figure 5-60. Lung protocol scan screen 1. Displays current segment name 2. Displays previous, current and next segments 5. 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.
Using Vscan Extend Apps Review and score images After all the images are stored for all the segments, a pop-up displays: Figure 5-61. Score images Press Score to score the images. Choose the score for each segment. OR Press 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. 1.
Using Vscan Extend Lung Protocol report After 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. Figure 5-64. Quantitative report Qualitative report Press 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. 5-60 Vscan Extend – User Manual 5721203-100 Rev.
Using Vscan Extend Apps Exit Lung Protocol 1. Press Menu on the Lung protocol screen. 2. Press Stop current protocol. A pop-up displays. Figure 5-65. Stop current protocol 3. Press Exit to stop the protocol. Vscan Extend – User Manual 5721203-100 Rev.
Using Vscan Extend Tricefy Tricefy Uplink helps to upload exams to the cloud. 1. Press Menu -> Settings -> GE Marketplace 2. Press Install. The Tricefy Uplink app installs. Using Tricefy 1. Press Menu -> Settings -> Server Settings 2. Press Tricey under Image Server Figure 5-66. 5-62 Tricefy Vscan Extend – User Manual 5721203-100 Rev.
Using Vscan Extend Apps Using 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 login 4. Press Add Server and Verify. Figure 5-68. Vscan Extend – User Manual 5721203-100 Rev.
Using Vscan Extend Using Tricefy (continued) 5. Press Menu -> Export icon. Figure 5-69. Export 6. Press Upload Selected to export the exam. Figure 5-70. Upload selected exam The selected exam(s) are exported to the Tricefy server. 5-64 Vscan Extend – User Manual 5721203-100 Rev.
Chapter 6 Vscan Extend Maintenance Contents ‘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 – User Manual 5721203-100 Rev.
Vscan Extend Maintenance System care and maintenance Overview 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 maintenance Inspection Inspecting the Vscan Extend 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. Examine the following on a monthly basis (or whenever there is a reason to assume that any issue may have occurred): • WARNING Connectors on cables, for any mechanical defects • Entire length of electrical cables, for cuts or abrasions • Equipment for cracks, loose or missing hardware.
Vscan Extend Maintenance Cleaning and disinfection Cleaning the device Make 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. CAUTION Do not spray the soap and water solution directly onto the Vscan Extend.
Cleaning and disinfection Special Label Designations, Warnings and Precautions Never 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 accessories Special accessories are not applicable. Point-of-Use Processing No point-of-use processing is required prior to cleaning. Vscan Extend – User Manual 5721203-100 Rev.
Vscan Extend Maintenance Cleaning instructions CAUTION 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. Cleaning the probe 1. 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.
Cleaning and disinfection Disinfecting the device After cleaning, the device may be wiped with a tissue sprayed with a recommended germicide. Recommended germicides In 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.
Vscan Extend Maintenance Cleaning agents Follow the instructions described below while using CaviWipes and Sani-Cloth HB. CaviWipes 1. 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.
Cleaning and disinfection Disinfecting the probe After 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.
Vscan Extend Maintenance Disinfecting the probe (continued) WARNING 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. Figure 6-2. 1. Maximum saline level 2. Minimum saline level WARNING Probe immersion level a.
Cleaning and disinfection Disinfecting the probe (continued) WARNING CREUTZFELDT-JAKOB DISEASE This 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.
Vscan Extend Maintenance Upgrade software Scanner software You 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.
Upgrade software Scanner 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.
Vscan Extend Maintenance Troubleshooting Vscan Extend troubleshooting Table 6-2: Problem Vscan Extend has no power. Vscan Extend is not charging. Troubleshooting Possible cause Solution 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) Battery not inserted.
Troubleshooting Table 6-2: Troubleshooting (Continued) Problem Possible cause Vscan 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. Battery may not have sufficient charge. Charge the Vscan Extend battery for at least 60 minutes. Vscan Extend is not entering the scan screen and stays on the GE start-up screen.
Vscan Extend Maintenance System Warning Messages System errors • System overheats System is overheating and will shut down. WARNING If the problem persists, contact GE service. • Probe overheats Probe is overheating and the system will shut down. WARNING If the problem persists, contact GE service. • Battery low Battery is critically low or below 15%. WARNING Plug in charger. • WARNING System voltage critical System voltage is at critical level and will shut down.
Troubleshooting System Warning Messages (continued) • Connectivity error Unable to connect. WARNING Check Wi-Fi connection. • Acquisition level Check battery and recharge the system. WARNING If the problem persists, contact GE service. System messages • Perform system backup System internal memory usage is 50 to 60%. WARNING Perform system backup. • Scanning not allowed WARNING Scanning is not allowed when AC is connected. WARNING Scanning is not allowed when connected to a PC.
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Chapter 7 Appendix Contents: ‘Specifications’ on page 7-2 ‘Acoustic Output Reporting Tables’ on page 7-3 ‘Measurement accuracy’ on page 7-12 Vscan Extend – User Manual 5721203-100 Rev.
Appendix Specifications Dimension and weight System 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: 65g Probe 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): 120g Phased a
Acoustic Output Reporting Tables Acoustic Output Reporting Tables Definitions, symbols and abbreviations The following definitions, symbols and abbreviations are used in the acoustic output reporting tables in this chapter: Table 7-1: IEC FDA Definitions, symbols and abbreviations Meaning—IEC 60601-2-37 / FDA & NEMA UD2, UD3 Acoustic Attenuation Coefficient / Derating factor (usually 0.
Appendix Table 7-1: IEC FDA Definitions, symbols and abbreviations (Continued) Meaning—IEC 60601-2-37 / FDA & NEMA UD2, UD3 Bounded Output Power / Power emitted from the central 1cm of aperture Pulse Pressure Squared Integral / Pulse intensity integral Peak-Rarefactional Acoustic Pressure / (same) Attenuated Peak-Rarefactional Acoustic Pressure / (same) Pulse Repetition Rate / Pulse repetition frequency Thermal Index / (same) Bone Thermal Index / (same) Cranial-Bone Thermal Index / (same) Soft-Tissue Ther
Acoustic Output Reporting Tables Explanation of Footnotes The 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.
Appendix Acoustic Output Reporting Tables for Track 3/EN/IEC 60601-2-37 Dual Probe Phased array transducer Operating Mode: black/white Figure 7-1. 7-6 Phased array transducer - black/white Vscan Extend – User Manual 5721203-100 Rev.
Acoustic Output Reporting Tables Dual Probe Phased array transducer Operating Mode: black/white and color Figure 7-2. Phased array transducer - black/white and color Vscan Extend – User Manual 5721203-100 Rev.
Appendix Dual Probe Linear array transducer Operating Mode: black/white Figure 7-3. 7-8 Linear array transducer - black/white Vscan Extend – User Manual 5721203-100 Rev.
Acoustic Output Reporting Tables Dual Probe Linear array transducer Operating Mode: black/white and color Figure 7-4. Linear array transducer - black/white and color Vscan Extend – User Manual 5721203-100 Rev.
Appendix Sector probe Phased array transducer G3S Operating Mode: black/white Figure 7-5. 7-10 Phased array transducer - black/white Vscan Extend – User Manual 5721203-100 Rev.
Acoustic Output Reporting Tables Sector probe Phased array transducer G3S Operating Mode: black/white and color Figure 7-6. Phased array transduce - black/white and color Vscan Extend – User Manual 5721203-100 Rev.
Appendix Measurement accuracy Basic Measurements The 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.
Measurement accuracy Speed of Sound in Tissue The 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). Vscan Extend – User Manual 5721203-100 Rev.
Appendix 7-14 Vscan Extend – User Manual 5721203-100 Rev.
Chapter 8 Privacy and Security Contents ‘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 Vscan Extend – User Manual 5721203-100 Rev.
Privacy and Security Introduction Overview This 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.
Introduction Privacy and Security Environment The 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.
Privacy and Security PIN restrictions The 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 Authentication The 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.
Introduction Audit logging content The following events are captured by the audit logging of the Vscan Extend: 1. Device Start/Shut-down time 2. Incorrect password attempts 3. Addition and Modifications to system configuration, including: a. DICOM connection b. Windows Share connection c. Application software installation/uninstallation/software upgrade d. Registration of partnering apps 4. Events related to Patient Data, including details of: e.
Privacy and Security Network Connectivity Overview Network connection for the Vscan Extend is required by several system features: 1. DICOM connectivity to other DICOM devices 2. Disk Management/Backup towards Windows share 3. Image/Video storage via the “JPG/MPEG” feature System interconnections The 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. 1. 2. 3. 4.
Network Connectivity System interconnections (continued) Device features • Supported Wireless Protocols include WEP, WPA2 with PSK and EAP with certificates • Log files • Data backup/restore • Software upgrade Wireless 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.
Privacy and Security Network Requirements Host Characteristic 1. TCP/IP network 2. Both DHCP and static IP allocation are supported Network Protocols Wireless network protocols The following wireless protocols are supported: 1. IEEE 802.11b 2. IEEE 802.11g 3. IEEE 802.11n Internet Protocol Version: 1. IPv4 2. IPv6 8-8 Vscan Extend – User Manual 5721203-100 Rev.
Information Protection Information Protection Overview This 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.
Privacy and Security Inbound firewall configuration All 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.
Information Protection Outbound firewall configuration All 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.
Privacy and Security Local 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.
Information Protection Wireless Security Due 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 protocols The following security protocols are supported on the wireless interface: 1. WEP 2. WPA/WPA2 PSK 3. 802.
Privacy and Security Data destruction for portable media The 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 Security Patient data is encrypted and images/videos/logs are unencrypted.
Information Protection Business Continuity To 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 solutions The 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 system 2.
Privacy and Security System Protection Vscan Extend – system protection The 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 access Users of the Vscan Extend do not have access to the Android system nor to the MST system (Linux) on the Vscan Extend Ultrasound system.
Personal Information Collected by the Product Personal Information Collected by the Product Information collection and use The 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.
Privacy and Security Manual 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.
Personal Information Collected by the Product Information disclosure If 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.
Privacy and Security Protection of personal information Individuals authorization for collection, use and disclosure of PI/PHI Some 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.
Personal Information Collected by the Product Potential Hazardous Situations Resulting From Failures of the IT Network Hazardous situations The 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.
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Index A L Activating Wi Fi, 4-21 Appendix, 7-1 Audit logs audit logs, 5-30 Auto freeze, 5-23 AutoCycle, 5-23 Lung Protocol Lung Protocol, 5-54 B P Battery Charge, 3-15 Level indicator, 3-19 Removing / inserting the battery (VE-BAT), 3-20 specifications, 3-21 Black and white imaging, 5-17 Bladder Volume Bladder Volume, 5-47 Package contents, 3-2 Patient examination, 5-7 Power on/off, 3-22 Preparing Vscan ExtendTM for Use, 3-1 Probe and Presets, 5-12 C Certificate Authority, 4-28 Cleaning and disinfe
USB export, 5-31 Using Vscan Extend, 5-1 V Voltage requirements, 3-17 Vscan Extend Battery, 3-15 Vscan Extend Maintenance, 6-1 Vscan Extend Settings, 4-1 Index-2 Vscan Extend – User Manual 5721203-100 Rev.
