Technical Publications Vscan Extend™ User Manual 5721203-100 — English Rev. 13 Operating Documentation Copyright © 2016-2019 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.X.X and 1.2.X application 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. 1 2016/08/30 Initial release Rev. 2 2016/10/13 Included EN13718 Updated the Environmental Requirements section Updated the latest screens for Worklist, Image server, Settings screen, Windows Share, Tricefy Updated Standby mode Updated Device PIN section Removed Restart section Updated probe temperature values Updated acoustic output tables for dual probe Rev.3 2017/03/23 Rating Plate Update Rev.
REV DATE (YYYY/MM/DD) REASON FOR CHANGE Rev. 11 2019/07/09 Updated Prescription device caution statement for USA only in Chapter 1 and 2. Updated “LVivo EF app” section in Chapter 5. Rev. 12 2019/08/12 Updated Vscan Extend rating label. Rev. 13 2019/11/13 Updated “Set Language, Date and Time” section in Chapter 3. Updated Settings section in Chapter 4. Updated Inbound and Outbound Firewall Configuration table in Chapter 8. Updated Operating System table with Android 9 version.
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 NEMA/AIUM UD-3 Standard for real-time display of thermal and mechanical acoustic output indices on diagnostic ultrasound equipment.
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.
Country Specific Approval • USA AND TERRITORIES The following optional feature IS NOT available in the USA and its territories: DANGER – Ophthalmic • JAPAN The following optional feature IS NOT available in JAPAN: DANGER – Ophthalmic • CHINA The following optional feature IS NOT available in CHINA: DANGER – Ophthalmic • SINGAPORE Complies with IMDA Standards N2062-17 • FRANCE First CE marked on 14 June 2016 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 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Mechanical hazards - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-6 Electrical hazard - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-7 Personnel and equipment safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-7 Explosion hazard - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-7 Electrical hazard - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-8 Electromagnetic Compa
Certificate Authority (Android Version 5.
Rinsing and Lubricating Agents - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-11 Upgrade software Scanner software - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-12 Upgrade MST firmware - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-14 Troubleshooting System shutdown error - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Additional messages - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - System Warning
Chapter 1 Introduction Contents: ‘Overview’ on page 1-2 ‘Warnings’ on page 1-7 ‘Contact Information’ on page 1-11 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 Wireless Description Wireless communication utilizes the 2.4GHz band supporting the IEEE 802.11b, IEEE 802.11g and IEEE 802.11n protocols. The wireless module supports bandwidths of 20MHz and 40MHz. Table 1-1: Wireless Description 1. Wireless network protocols supported IEEE 802.11b/g/n 2. Frequency bands of transmission / reception 2.4GHz 3. Preferred frequency or frequency band 2.4GHz 4. Bandwidth(s) supported 20MHz and 40MHz 5. Effective Radiated Power of 2.4GHz Wi-Fi 96.
Introduction Intended use 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. 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.
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 • Keep good hand contact with Vscan Extend during scanning to avoid heating up of the unit and termination of scan due to built-in temperature limits. • At times, user may be required to enter PIN to save patient data. It is extremely important to remember this PIN in order to avoid loss of patient data in case of entering wrong PIN multiple times or if the user forgets the PIN.
Warnings Important Safety Considerations (continued) WARNING Avoid contact with the rechargeable battery if it appears to be leaking. Battery fluid is corrosive, and contact with it can result in personal injury and/or property damage. To prevent injury or damage: WARNING • If the battery leaks, avoid contact with the battery fluid. If any liquid from the battery should come in contact with the eye, immediately wash the eye with plenty of water and seek medical advice as soon as possible.
Introduction Important Safety Considerations (continued) CAUTION CAUTION 1-10 • Ensure to backup data regularly and to erase the data before sending the Vscan Extend for service. • To access or add patient information, a device pin is required. Ensure not to lose the pin. Vscan Extend cannot be sterilized. Apply a sterile sheath if the device is going to be used in an application where a higher degree of cleanliness is required.
Contact Information 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.
Introduction Accessories Catalog Requests To request the latest GE Accessories catalog or equipment brochures in the United States, call the Response Center TEL: (1) 800-643-6439 In other locations, contact your local Applications, Sales or Service Representative. Placing an order To place an order, order supplies or ask an accessory-related question in the United States, call the GE Access Center TEL: (1) 800-472-3666 In other locations, contact your local Applications, Sales or Service Representative.
Contact Information Europe, Middle East and Africa Table 1-3: 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.
Introduction Table 1-3: 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) 1-14 Vscan Extend – User Manual 5721203-100 Rev.
Contact Information Asia and Pacific Table 1-4: 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 Cont
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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 2-22 ‘Device labels and symbols’ on page 2-23 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 or other authorized licensed healthcare practitioner.
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. It complies with emission limits in RTCA DO-160G, Section 21, Category M when in Flight mode with Wi-Fi OFF.
Important safety considerations Electromagnetic Compatibility (EMC) (continued) To comply with the regulations on electromagnetic interference, all interconnecting cables to peripheral devices must be shielded and properly grounded. Use of cables not properly shielded and grounded may result in the equipment causing or responding to radio frequency interference, in violation of the European Union Medical Device Directive and FCC regulations.
Safety WARNING The use of accessories and cables other than those specified, may result in increased electromagnetic emissions or decreased electromagnetic immunity of the Vscan Extend. WARNING The Vscan Extend should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the Vscan Extend should be observed to verify normal operation in the configuration in which it will be used.
Important safety considerations 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.
Safety Electromagnetic emissions Table 2-1: Electromagnetic emissions Guidance and manufacturer’s declaration – electromagnetic emissions. 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. Emissions test Compliance Electromagnetic environment - guidance RF emission EN55011 Group 1 The Vscan Extend uses RF energy only for its internal function.
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 Essential Performance The essential performance of the Vscan Extend is: • The ability to display physiological images as input for diagnosis by qualified and trained healthcare professionals. • The ability to display quantified data as input for diagnosis by qualified and trained healthcare professionals. • The display of ultrasound indexes as aid for safe use of the Vscan Extend.
Safety FDA guidance of September 9, 2008 for diagnostic ultrasound systems and transducers. 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.
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 2-18 and ‘System controls affecting acoustic output’ on page 2-19 should be studied carefully in order to implement ALARA.
Safety Maximum probe temperature The table below indicates the maximum probe temperature. Table 2-6: 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 44.7 Vscan Extend – configured with Dual probe: Phased array transducer (G3S) for Deep scanning 38.5 43.
Device labels and symbols Device labels and symbols Vscan Extend Labels Figure 2-2. 1. 2. 3. 4. Vscan Extend rating label Rating label Inner label Reference and UDI label - contains reference and UDI information Serial number label - contains device serial number NOTE: 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 (continued) Figure 2-3. Vscan Extend battery label Figure 2-4. Vscan Extend AC/DC adapter label Figure 2-5. 2-24 Vscan Extend external battery charger label Vscan Extend – User Manual 5721203-100 Rev.
Device labels and symbols Vscan Extend Labels (continued) Figure 2-6. Figure 2-7. Vscan Extend – User Manual 5721203-100 Rev.
Safety Vscan Extend Labels (continued) The following table describes the purpose of safety labels and other important information provided on the equipment. Table 2-7: Label 2-26 Label Icons Purpose Location Standard CE mark • Vscan Extend system • Vscan Extend External Battery charger N/A - by certification body This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately.
Device labels and symbols Table 2-7: Label Assembled in Romania (Romania is a country name) Label Icons (Continued) Purpose Location Standard Rechargeable, use only Vscan Extend battery.
Safety Table 2-7: Label Label Icons (Continued) Purpose FCC ID: YOMVSCANEXTEND IC ID: 9136A-VSCANEXTEND FCC ID IP33 • 3: Protected against solid foreign objects of 2.5 mm Ø and greater. • 3: Protected against spraying water. NOTE: 2-28 Location Standard Vscan Extend system FCC Part 15:Subpart CRSS-247 Vscan Extend system IEC 60529 IC ID As a safety precaution, scanning is not possible when charging the battery. Vscan Extend – User Manual 5721203-100 Rev.
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 2-8: 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
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Chapter 3 Preparing Vscan Extend for Use Contents: ‘Package contents’ on page 3-2 ‘System description’ on page 3-6 ‘Battery’ on page 3-18 ‘First time use’ on page 3-25 ‘Activation’ on page 3-27 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 3-2 Vscan Extend – User Manual 5721203-100 Rev.
Package contents Table 3-1: Item Package content (Continued) Description Vscan Extend User Manual CD/DVD Service contact information Vscan Extend – User Manual 5721203-100 Rev.
Preparing Vscan Extend for Use 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 15–95% 15–95% 15–95% 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: • Temperature range of -
Environmental requirements Acclimatization time Allow the unit to acclimate for approximately 10 minutes, if stored at temperatures ranging from -20°C to +50°C. Allow the unit to acclimate for approximately 30 minutes, if stored at temperatures outside the transient environmental operating conditions -20°C to +50°C. Other environment: Aircraft Ambulance/Road Ambulance The Vscan Extend can be used in an emergency medical services environment, including road and air ambulances*,** .
Preparing Vscan Extend for Use System description System overview The Vscan Extend is configured with a Sector probe for deep scanning. Figure 3-2. Vscan Extend with a Sector probe 1. Display 2. Sector probe 3. Serial port (For Service ONLY) NOTE: 3-6 4. Power button 5. USB port and Power connector 6. LED indicates charging status A green LED indicates the Vscan Extend is fully charged; an amber LED indicates the device is charging. Vscan Extend – User Manual 5721203-100 Rev.
System description System overview (continued) The Vscan Extend is configured with a Dual probe holding both a phased array and linear array transducer for deep and shallow scanning. Figure 3-3. Vscan Extend with Dual probe 1. Display 2. Dual probe 3. Serial port (For Service ONLY) NOTE: 4. Power button 5. USB port and Power connector 6. LED indicates charging status A green LED indicates the Vscan Extend is fully charged; an amber LED indicates the device is charging.
Preparing Vscan Extend for Use System overview (continued) Figure 3-4. The dual probe 1. Phased array transducer (deep scanning) 2. Linear array transducer (shallow scanning) 3-8 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*) 5. MicroSD memory card (contains Application Software and Firmware) 6. Soft case 7. User Manual CD/DVD 8. Hardcopy Quick Card 9.
Preparing Vscan Extend for Use 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 8. Vscan Extend Stand 3-10 Vscan Extend – User Manual 5721203-100 Rev.
System description 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.
Preparing Vscan Extend for Use 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.
System description Vscan Extend Stand (option) Vscan Extend stand is used to keep the device on a table top or patient’s bedside. Follow the instructions below to use the Vscan Extend stand. 1. Hold the stand and gently slide it downwards as shown in the figures below (Figure 3-7 and Figure 3-8). Figure 3-6. Figure 3-7. Vscan Extend stand Keep device on stand 2. Ensure that the device does not rest on the probe cable’s strain relief “A” as shown in Figure 3-9.
Preparing Vscan Extend for Use Vscan Extend Stand (option) (continued) Figure 3-8. Slide stand on device 3. Recommended position for stand is as shown in figure below (Figure 3-9). Figure 3-9. Vscan Extend on the stand 4. Slide out the stand in reverse order to disengage from the device. 3-14 Vscan Extend – User Manual 5721203-100 Rev.
System description Display screens Figure 3-10. 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 • Store • Gain • Depth NOTE: Linear array transducer 1. Header • Menu icon • Patient information • Exam number • Battery level indicator • MI and TI values 2. Depth scale 3.
Preparing Vscan Extend for Use Display screens (continued) Figure 3-11. 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 • Store • Gain • Depth 4. Color bar 5. Color ROI (Region of Interest) 3-16 Scanning screens (Color mode) 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 3-12. Menu screen Vscan Extend – User Manual 5721203-100 Rev.
Preparing Vscan Extend for Use Vscan Extend Battery Battery The Vscan Extend system is powered by a Li ION battery. 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.
Vscan Extend Battery Battery (continued) WARNING Use only the AC adapter provided with the Vscan Extend. Figure 3-14. Vscan Extend AC adapter CAUTION The AC adapter must be kept outside the patient environment (refer to local regulation and EN 60601-1). Figure 3-15. Patient environment 1. Patient environment WARNING Do NOT simultaneously touch the patient and the charger plug on the AC adapter. Vscan Extend – User Manual 5721203-100 Rev.
Preparing Vscan Extend for Use Power plugs 1. Select the country specific plug. Figure 3-16. 1. North America, Japan 2. China 3. Australia, New Zealand Power plugs 4. UK, Hong Kong, Singapore 5. Continental Europe and Korea (for unearthed electrical outlet) 2. Insert the relevant plug into the adapter. Figure 3-17. Insert the plug Voltage requirements The AC/DC adapter will function on voltage from 100 to 240 VAC and 50/60 Hz. CAUTION NOTE: 3-20 Only use mains power of 100 – 240 VAC.
Vscan Extend Battery Charging the battery 1. Insert the battery into the device. Figure 3-18. 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.
Preparing Vscan Extend for Use 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 (>=85%). Battery charged (65% to 84%). Battery charged (35% to 64%). Battery critical, or low Battery (17% to 34%). Battery fully discharged (<17%). Recharge immediately. Prepare to recharge the battery or have a spare battery available. Battery charging.
Vscan Extend Battery Inserting/removing the battery To insert the battery 1. Insert the battery in the compartment until the lid clicks in place. Figure 3-19. 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 3-20. Vscan Extend – User Manual 5721203-100 Rev.
Preparing Vscan Extend for Use 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.
Initial 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 3-23 for more information.) 2. Press the Power button to power on Vscan Extend. 3. Activate Vscan Extend. (See ‘Vscan Extend activation’ on page 3-27 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.
Preparing Vscan Extend for Use 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 5 to 7 seconds.
Initial 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. If there is no internet access, contact GE Service (see page 1-12 for phone numbers) to activate Vscan Extend.
Preparing Vscan Extend for Use Set Language, Date and Time (Android Version 5.1) NOTE: Go to Menu -> About to verify the android version. 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 3-21. Select language 4. Choose the desired language. The screen changes back to the Language screen. 5.
Initial use Set Language, Date and Time (Android Version 5.1) (continued) 6. Press Change Date and Time to change the date and time, if needed. Figure 3-22. 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. 7. Press Next. Vscan Extend – User Manual 5721203-100 Rev.
Preparing Vscan Extend for Use Set Language, Date and Time (Android Version 9) NOTE: Go to Menu -> About to verify the android version. 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 3-23. Select language 4. Press Add Language to choose the desired language. Figure 3-24.
Initial use Set Language, Date and Time (Android Version 9) (continued) 5. To activate the selected language, press and hold of the desired language (e.g. Dansk) and drag it to the top. Figure 3-25. Language Activation 6. Press screen. .The screen changes back to the Language 7. Press Next. The Date and Time screen displays. Figure 3-26. Language Activation NOTE: The current date and time is set by default. Vscan Extend – User Manual 5721203-100 Rev.
Preparing Vscan Extend for Use Set Language, Date and Time (Android Version 9) (continued) 8. Press Change Date and Time to change the date and time, if needed. Figure 3-27. 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. 9. Press Next. 3-32 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 4-28 for more information. Figure 3-28. Wi-Fi settings Select your Wi-Fi network and enter your Wi-Fi password. (All non hidden Wi-Fi networks are displayed.) NOTE: If Wi-Fi is not ON, press Menu -> Advanced settings -> turn ON Wi-Fi. NOTE: Ensure that the Vscan Extend is connected to a non-clinical Wi-Fi hotspot to start activation.
Preparing Vscan Extend for Use Connecting Wi-Fi (continued) 1. Enter the authentication details to connect to the network. Figure 3-29. 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 3-28 on page 3-33.) 3. Press Next. 3-34 Vscan Extend – User Manual 5721203-100 Rev.
Initial use Registration Registering the device creates a Vscan Extend GE Marketplace account. First time registrants 1. First time registrants, press Register to create an account. Enter the required details. Figure 3-30. Registration details NOTE: HINTS If you have previously registered a Vscan Extend device, press Already Registered using your registered email. See ‘Registered users’ on page 3-37 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 set your password for security purposes. 4. Press Activate my device. Figure 3-32. Choose an option 5. Vscan Extend has been activated. Press Start Using Device. Figure 3-33.
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 3-34. 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 3-35. 3-38 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 3-36. 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 3-37. 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 3-38. Retry 2. If the problem persists, contact GE Service or your local Sales representative. 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 3-41 for more information. 3-40 Vscan Extend – User Manual 5721203-100 Rev.
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) 4. Enter other necessary details. Figure 3-40. Figure 3-41. Opt-in checkbox Opt-in communication 5. Press Submit to initiate registration. Figure 3-42. Submit 6. The Activation key is generated. Store the key in a convenient location to enter into the device and for future reference. Figure 3-43. 3-42 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 3-44. Enter activation key HINTS Press the Backspace key if a mistake occurred while entering the activation key. 2. Press Activate. Figure 3-45. 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 3-44 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 4-20 ‘Wi-Fi’ on page 4-27 ‘MDM Installation Procedures for Android Version 5.1 (Optional)’ on page 4-30 ‘Certificate Authority (Android Version 5.1)’ on page 4-35 ‘GE Marketplace’ on page 4-45 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. Worklist server 4-4 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 3-27 for more information. 1. Enter all fields to add a new Worklist server. Figure 4-5. Configure Worklist Server NOTE: 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 to add the Worklist Server. 4. Press Verify to verify communication with the Worklist Server. “Verify OK” pop-up displays if the communication with the Worklist Server is ok.
Settings Configure Worklist Server (continued) • Press and hold the selected Worklist entry to add to the favorites list. By default, the first added Worklist server is set as the favorite. To remove a Worklist server from the favorites list, press and hold on the server name. If you wish to change it, press and hold to remove the current favorite and add the preferred server. Figure 4-8. Add to favorites Figure 4-9.
Vscan Extend Settings Configure Worklist Server (continued) • To add another Worklist server, press Add (+). Figure 4-10. • Add another Worklist server To delete the Worklist Server, press the Delete icon. Figure 4-11. Delete Worklist 4-8 Vscan Extend – User Manual 5721203-100 Rev.
Settings Configure Image Server 1. Press Menu -> Settings Figure 4-12. Menu 2. Scroll down to Server Settings. Press Image Server. Figure 4-13. Vscan Extend – User Manual 5721203-100 Rev.
Vscan Extend Settings Configure Image Server (continued) 3. Enter Name, your Image server’s IP address, port number, and Remote AE Title. Figure 4-14. 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. 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. “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. NOTE: If verify fails, a user rejection message (for example) displays. Figure 4-15.
Vscan Extend Settings Configure Image Server (continued) 6. Press and hold the Image Server to add the selected Image Server to favorites. Figure 4-16. Figure 4-17. NOTE: Add to favorites Image Server favorite 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. 7. To add another Image server, press Add (+). Figure 4-18.
Settings System Settings Figure 4-20. WARNING System Settings • Admin Settings - Change date, time and configure Wi-Fi • Connect Network - shows the available networks to connect and to turn ON/OFF Airplane mode • GE Marketplace - Select an app • Facility Name - Set Facility Name • Station Name - Set Station 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 - View the enabled modules. Figure 4-21. Configuration Press View Modules to obtain the list of enabled modules. and enter the option key Figure 4-22. Enabled modules 4-14 • My Account - Set User account • Upgrade Software - Upgrade Scanner application • About - Provides device information Vscan Extend – User Manual 5721203-100 Rev.
Settings Backup/Restore • Backup - Save Patient Exam, Configurations and Logs to SD card • Restore - Restore Patient Exam and Configurations from SD card Software Update The Software Update allows to update Vscan Extend firmware, GE Marketplace, GE Kiosk, and Vscan Extend application through the internet. New versions of these software applications can be downloaded from GE Server. You can choose either install or cancel the update.
Vscan Extend Settings Update over the internet (Applicable to systems with software version 1.2.X) (continued) 2. Press Update to download all the software updates. Figure 4-24. Download softwares NOTE: If the device loses network connectivity (with non-clinical network) when update is getting detected or downloaded, the update process gets cancelled. Restart the update process once again. 3. The device prompts you to install the softwares one by one. Press install button after each update. Figure 4-25.
Settings Update over the internet (Applicable to systems with software version 1.2.X) (continued) Figure 4-26. Update GE Marketplace Figure 4-27. Vscan Extend – User Manual 5721203-100 Rev.
Vscan Extend Settings Update over the internet (Applicable to systems with software version 1.2.X) (continued) Figure 4-28. Update Firmware Figure 4-29. NOTE: Update OS patch Device must not be powered off while installing Firmware update. It gets powered off automatically once installation completed. Make sure the battery is 100% charged or AC is connected while updating the Firmware. 4. Press power button to start the device. 4-18 Vscan Extend – User Manual 5721203-100 Rev.
Settings OS Patch Update (Android Version 5.1) To update an OS patch manually Figure 4-30. Update OS patch 1. Press Menu -> Admin Settings -> Settings. 2. Press About phone -> Software Update. Check for any latest updates if available. NOTE: OS patch info displays “OS is at latest patch level, No OS patch update needed for this device.” if no updates available. 3. Press Continue. OS update process starts. Wait till OS update gets completed. 4. Press power button to start the device.
Vscan Extend Settings Application Settings Choose formula for bladder volume Diagnostics Figure 4-31. 4-20 Diagnostics • System Diagnostics - Performs main board or hardware diagnostics • Display Test - Perform this test if there is a problem with the display. Use a swiping motion to navigate through all the screens. If an issue persists, contact GE Service. 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 admin password for security purposes. Figure 4-32. Create admin password Password must be a minimum of 8 digit in length. It must contain: • A small letter (a-z). • A capital letter (A-Z). • A special character (@, #, $, %, ^, &, +, =, !). 2. Confirm the new admin password for security purpose. Figure 4-33.
Vscan Extend Settings Administrator Access (continued) CAUTION This password is critical to accessing device settings which include some critical settings and configurations. Any changes made in the device settings might affect the performance of the device. Follow the instructions provided on the password security screen while accessing the device settings. Avoid sharing this password with non-administrators and take precautions to not lose this password.
Settings Storage Access – Device PIN 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 when: • Images/videos are stored in the spooler • User wishes to store an image/video • The session duration time has expired 1. Create a new PIN (four digit number) for data storage and access, for example, 1234. Figure 4-35. User PIN 2.
Vscan Extend Settings Storage Access – Device PIN (continued) A PIN security note also displays 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 4-37. Remember PIN The PIN provides access to data storage and retrieval during normal use.
Settings Incorrect Device PIN (continued) 1. A pop-up message displays when an incorrect PIN is entered. Figure 4-38. 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 5-44 for more information. Figure 4-39. Vscan Extend – User Manual 5721203-100 Rev.
Vscan Extend Settings Incorrect Device PIN (continued) 3. A pop-up message displays for every incorrect PIN entry thereafter. For example, 4, 3, 2, 1 attempt(s) left. Figure 4-40. Remaining attempts NOTE: It is recommended to back-up data on a microSD card before the last attempt. After the 10th attempt, the system resets (data is deleted from device storage) and goes back to the initial screen where a new PIN should be entered as shown in Figure 4-35 on page 4-23.
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 4-41. Admin Settings 2. Enter the Admin PIN to access advanced settings (settings of the operating system). See ‘Administrator Access’ on page 4-21 for more information. 3.
Vscan Extend Settings Configuring Wi-Fi NOTE: Go to Menu -> About to verify the android version. For Android Version 5.1 1. Press Wi-Fi. Figure 4-43. Menu 2. Press the ON/OFF button on the right to turn ON Wi-Fi. Choose the network if you know the credentials or contact your system administration 4-28 Vscan Extend – User Manual 5721203-100 Rev.
Settings For Android Version 9 1. Press Network & internet -> Wi-Fi. Figure 4-44. Menu 2. Press the ON/OFF button on the right to turn ON Wi-Fi. 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 4-45. Mac address Vscan Extend – User Manual 5721203-100 Rev.
Vscan Extend Settings Deleting Wi-Fi networks (Android Version 5.1) 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. Deleting Wi-Fi networks (Android Version 9) 1. Press Settings from the Dashboard. 2. Press Network & internet -> 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.
Settings MDM Installation Procedures for Android Version 5.1 (Optional) (continued) Figure 4-46. Google Play Store 3. Install the correct MDM agent from Google Play Store (For example: Airwatch*, MobileIron**). *Airwatch is registered trademark or trademark of VMware, Inc. or its subsidiaries in the United States and other jurisdictions. **MobileIron is trademark of MobileIron Company or MobileIron’s licensors. NOTE: GE is not responsible if the user installs other MDM agents.
Vscan Extend Settings MDM Installation Procedures for Android Version 5.1 (Optional) (continued) Figure 4-47. MDM 4. View the MDM service client with the help of your IT department. Figure 4-48. MDM installed 5. Press the Back arrow to go to Dashboard. 6. Press Kiosk Settings. NOTE: 4-32 Kiosk Settings provides access to advanced settings. Vscan Extend – User Manual 5721203-100 Rev.
Settings MDM Installation Procedures for Android Version 5.1 (Optional) (continued) Figure 4-49. Kiosk Settings 7. Press Admin Console App Chooser. Figure 4-50. Vscan Extend – User Manual 5721203-100 Rev.
Vscan Extend Settings MDM Installation Procedures for Android Version 5.1 (Optional) (continued) 8. Select the MDM Agent and press Update. Figure 4-51. Select MDM Agent Figure 4-52. Update The MDM agent is listed in the Dashboard. 4-34 Vscan Extend – User Manual 5721203-100 Rev.
Settings Certificate Authority (Android Version 5.1) NOTE: Go to Menu -> About to verify the android version. 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.
Vscan Extend Settings Certificate Authority (Android Version 5.1) (continued) 2. Press Install certificate. Figure 4-54. Install certificate To complete the install, you need to add the certificate to your device's security credentials. 4-36 • 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.
Settings Certificate Authority (Android Version 5.1) (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 4-55. 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. Vscan Extend – User Manual 5721203-100 Rev.
Vscan Extend Settings Certificate Authority (Android Version 9) NOTE: Go to Menu -> About to verify the android version. 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.
Settings Certificate Authority (Android Version 9) (continued) 2. Press Wi-Fi Preferences -> Install certificates. Figure 4-57. Install certificate To complete the install, you need to add the certificate to your device's security credentials. • Press Security & Location -> Encryption & credentials 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 (Android Version 9) (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 4-58. 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.
Settings Certificate Authority (Android Version 9) (continued) • Select the certificate from Downloads. Figure 4-59. Certificate A popup displays prompting to set lock for the device. Figure 4-60. Attention popup Vscan Extend – User Manual 5721203-100 Rev.
Vscan Extend Settings Certificate Authority (Android Version 9) (continued) • Press SET LOCK -> PIN. Figure 4-61. Setting Screen Lock Below secure start-up message is displayed. Press NO (recommended) to avoid security authorization everytime the device reboots. Figure 4-62. Secure start-up 4-42 Vscan Extend – User Manual 5721203-100 Rev.
Settings Certificate Authority (Android Version 9) (continued) • Create a new PIN (four digit number) for certificate authorization, for example, 1234. Figure 4-63. Security PIN Confirm the PIN for security purpose. Confirmation is only required after PIN creation. Figure 4-64. Vscan Extend – User Manual 5721203-100 Rev.
Vscan Extend Settings Certificate Authority (Android Version 9) (continued) • Select Don’t show notifications at all option. Press DONE. Figure 4-65. Permission 4-44 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 and Tricefy Uplink on the Vscan Extend. * Applications under GE Marketplace are available as options (not available in all geographies). NOTE: The password needed to access GE Marketplace can be created by following the link provided in the confirmation email during registration. Figure 4-66.
Vscan Extend Settings Installing Vscan Extend apps 1. Press GE Marketplace on the Settings screen. Figure 4-67. GE Marketplace Figure 4-68. 4-46 Connecting to GE Marketplace Vscan Extend – User Manual 5721203-100 Rev.
Settings Installing Vscan Extend apps (continued) 2. List of available Vscan Extend apps are displayed. Figure 4-69. List of Vscan Extend Apps 3. Select the app (for example, Bladder Volume). Press Install. Figure 4-70. 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 apps via GE 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, Tricefy). Figure 4-71. Update available NOTE: If no apps have been installed, a message displays “You have no apps installed yet” under Installed tab. NOTE: While the apps are updating, there is no loss of data. The updated app requires no new permission. Uninstalling apps 1.
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 4-73. 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 4-75. Request for confirmation email A message displays: This Vscan Extend device has been registered to your account. The user account details page displays. Figure 4-76. Account details Press the Back arrow and press GE Marketplace. 4-50 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 5-49 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 ‘Using Germicides’ 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. Edit patient details 5-8 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 ModalityWorklist broker’ on page 5-38 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 Ophthalmic* Ophthalmic * Ophthalmic is available as an option for all countries but is NOT avail
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. Change Preset 5-14 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. Menu page NOTE: 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 5-10). 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. Black and white scan screen NOTE: 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 (in m/s) 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 Distance. 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 5-44 for more information.
Review and recall of stored data Reviewing and recalling images or videos from an exam list (continued) Figure 5-22. View stored images and videos NOTE: Press on the stored image in the Exams screen. Use the right/ left arrow to navigate through the images/videos. Figure 5-23. Vscan Extend – User Manual 5721203-100 Rev.
Using Vscan Extend Search patient To view previous exam details for a patient See Figure 5-22 on page 5-27: 1. Press the Search icon on the exam list screen. Figure 5-24. Search patient 2. Enter the patient name or patient ID in the search field. Previous exam details for this patient displays. 5-28 Vscan Extend – User Manual 5721203-100 Rev.
Review and recall of stored data 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 5-25. Images to be deleted 6. Press Delete to delete the images. OR 7. Press Cancel to cancel deletion. Figure 5-26. Vscan Extend – User Manual 5721203-100 Rev.
Using Vscan Extend Delete images from an exam list 1. Press Menu. 2. Press Exams. 3. Select the exam from the list. Figure 5-27. Images to be deleted 4. Press Delete to delete the images. OR 5. Press Cancel to cancel deletion. 5-30 Vscan Extend – User Manual 5721203-100 Rev.
Review and recall of stored data Data Export Data can be exported to a PC (‘Windows share’ on page 5-33), shared to a PC, exported to a DICOM server (‘DICOM Store: exporting DICOM images from Vscan Extend to DICOM image server’ on page 5-41), through USB (‘USB Export’ on page 5-32) or Tricefy Uplink (‘Tricefy Uplink app’ on page 5-64), if available on the device purchased. Audit Logs The Vscan Extend has audit logs of various types of events and activities.
Using Vscan Extend USB Export Patient images and videos can be transferred from Vscan Extend to a Personal Computer (PC) using a USB cable. NOTE: The Vscan Extend is charged only with the AC adapter. The USB cable, connected to a PC, does not charge the device. 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 a random number.
Review and recall of stored data Windows share Windows share allows the system to send ultrasound images to a PC. 1. Create a shared folder on the PC and provide the credentials and domain name. 2. Provide access to users who need access to the shared folder. 3. Press Windows share from the list. Enter the required details - Name, Domain, Remote IP Address, Share Folder, User name and Password. Figure 5-28. Windows share 4. Press Add. NOTE: All the required fields need to be entered. 5. Press Verify.
Using Vscan Extend 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 shown in the Figure 5-29 below. Figure 5-29. Exported image folder 5-34 Vscan Extend – User Manual 5721203-100 Rev.
Review and recall of stored data Share images (continued) Figure 5-30. Images inside the exam folder 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. Vscan Extend – User Manual 5721203-100 Rev.
Using Vscan Extend Device Status To monitor DICOM and Windows share jobs, press Menu -> Device Status. Figure 5-31. Device Status 5-36 Vscan Extend – User Manual 5721203-100 Rev.
Review and recall of stored data 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.
Using Vscan Extend DICOM Modality Worklist: Retrieve patient information from DICOM ModalityWorklist 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. Press Menu - > Worklist.
Review and recall of stored data DICOM Modality Worklist: Retrieve patient information from DICOM ModalityWorklist broker (continued) 2. Press Refresh to download Worklist entries. Figure 5-33. Refresh Worklist 1. Refresh 2. Search NOTE: It is not be possible to change the following DICOM attributes received from worklist: Patient Name, Patient ID and Accession Number. NOTE: If there are no scheduled cases for the dates, a pop-up messages displays.
Using Vscan Extend DICOM Modality Worklist: Retrieve patient information from DICOM ModalityWorklist broker (continued) 3. Press the Search icon to search a particular patient. See Figure 5-33 on page 5-39 4. Enter the patient name or patient ID. Figure 5-34. New exam A new exam automatically gets created for this patient. Figure 5-35. New exam 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 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 5-36. Exams 2. Press the Export icon. Figure 5-37. 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 5-38. Choose destination 4. Press Upload Selected to export the exam. Figure 5-39. Upload selected exam The selected exam(s) are exported to the DICOM server. 5-42 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. NOTE: Press ‘i’ icon to view the error message. NOTE: To refresh the screen to see the current status, exit the page and return to the same page. Figure 5-40.
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) 6. A pop-up displays. Figure 5-42. Backup data message Press Allow to initiate backup OR Cancel to stop the backup process. 7. 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 5-43. Vscan Extend – User Manual 5721203-100 Rev.
Using Vscan Extend Backup (continued) If the backup process is unsuccessful, a failed message displays. Figure 5-44. 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. 8. After backup is complete, power OFF the Vscan Extend. Remove the battery. Remove the backup microSD card and store in a safe place. 9.
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 5-44 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) 6. A pop-up displays. Figure 5-46. Restore Confirmation Press Allow to initiate restore OR Cancel to stop the restore process. 7. 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 5-47. Restore failed If the microSD card does not contain any patient details to restore, a pop-up displays. The system automatically shuts down. Figure 5-48.
Using Vscan Extend apps Using Vscan Extend apps Overview The following apps are applicable for the software version 1.X.X. For more information contact your local applications, sales or service representative. • Bladder Volume app • Lung Protocol app • Tricefy Uplink app The following apps are applicable for the software version 1.2.X. For more information contact your local applications, sales or service representative.
Using Vscan Extend Bladder Volume app The Bladder Volume app is a protocol enabled measurement tool for calculating urinary bladder volumes. The protocol includes an edge-detection algorithm that suggests and automatically places the measure calipers for transverse and sagittal view. These measurements can be accepted or adjusted manually by the user to get the bladder volume.
Using Vscan Extend apps Using Bladder Volume To use the bladder app, the following are prerequisites: • Install the app using GE Marketplace. • Sector 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 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 5-52. Transverse measure 1. D1 - Longitudinal maximum length 2. D2 - AP diameter NOTE: The Transverse Measure screen is displayed by default.
Using Vscan Extend apps Using Bladder Volume (continued) 4. Adjust the measurement calipers manually, if required. 5. Press Store. The screen enters sagittal capture. If you wish to quit the sagittal capture and return to live scanning screen, press the Close button. 6. Press to Freeze. Scroll to select the best frame. 7. Press Measure Frame. Figure 5-54. Measure Frame The image, along with the measurement values and volume, displays. Figure 5-55. Measurement values 8. Press Store.
Using Vscan Extend 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. Exiting Bladder Volume 1. Press Close to exit the Bladder Volume App. Figure 5-56. Exit Bladder Volume App 1. Close 2. Quit A pop-up displays for confirmation. 2. Press Quit to exit the Bladder Volume app. 3. Press Cancel to continue using the Bladder Volume app.
Using Vscan Extend apps Lung Protocol app The Lung Protocol provides a template to systematically acquire and evaluate thoracic ultrasound images. Images will be acquired in a defined order by thorax area. After completing image acquisition for whole thorax, each area can be reviewed and scored or qualitatively assessed. A simple report is summarizing findings. The lung protocol can be configured by number of thoracic areas, and by choice between qualitative assessment and scoring.
Using Vscan Extend Lung Protocol settings (continued) The Settings screen displays. Figure 5-58. Settings The Settings menu has the following functions: • choose the number of segments to be scanned • choose the type of assessment • enable/disable 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: 5-56 • 4x2 • 7x2 • 6x2 Vscan Extend – User Manual 5721203-100 Rev.
Using Vscan Extend apps 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 helps the user with tips during the Lung Protocol. Swipe from left to right to turn ON the Help mode on the Lung Protocol Settings menu. See Figure 5-58 on page 5-56.
Using Vscan Extend Lung Protocol settings (continued) 3. Press the Back arrow to return to the Protocols screen. Figure 5-59. 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 5-60.
Using Vscan Extend apps Using Lung Protocol (continued) 4. The lung linear preset is automatically applied. The cardiac preset is added as favorite to easily switch to deeper organ scanning. Figure 5-61. Preset menu The scan screen displays. Figure 5-62. Lung protocol scan screen 1. Displays current segment name 2. Number and site indicator of current segment 5. Press Store to save the images or Cine loops for the current segment.
Using Vscan Extend Using Lung Protocol (continued) 6. Swipe from right to left to move to the next segment, for example 1R to 2R, where 1R is the first segment of the right thorax. Similarly, 1L is the first segment of the left thorax. OR Swipe from left to right to move to the previous segment. The number of segments that can be scored depends on the number of segments selected on the Settings menu. 5-60 NOTE: The user is able to store multiple images per segment.
Using Vscan Extend apps Review and score images After all the images are stored for all the segments, a pop-up displays: Figure 5-63. 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 5-64. Quantitative and Qualitative Scores 1.
Using Vscan Extend Lung Protocol report The report shows the current patient name, patient ID, and total lung score. Figure 5-65. Quantitative report Figure 5-66. 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. 5-62 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 5-67. Stop current protocol 3. Press Exit to stop the protocol. Vscan Extend – User Manual 5721203-100 Rev.
Using Vscan Extend Tricefy Uplink app The Tricefy™ Uplink app includes the interface to Tricefy. Tricefy is a cloud-based solution to support archiving, collaboration and exchange of images, clips and reports. Start a free trial by registering with your email address. Your Vscan Extend will immediately be cloud-enabled giving you an offsite secure image archive, a zero-footprint DICOM viewer and all the sharing and collaboration features in Tricefy. Tricefy is a product of Trice Imaging.
Using Vscan Extend apps Configure Tricefy Uplink (continued) 3. Enter the email ID registered with the Tricefy Uplink. Figure 5-69. Tricefy Uplink Active 4. Press Add Server -> Verify. Figure 5-70. Vscan Extend – User Manual 5721203-100 Rev.
Using Vscan Extend Using Tricefy Uplink App 1. Press Menu -> Exams -> Export icon. Figure 5-71. Export 2. Press Upload Selected to export the exam. Figure 5-72. Upload selected exam The selected exam(s) are exported to the Tricefy server. NOTE: 5-66 If several storage destinations are configured, the user needs to select the intended destination, in this case, the Tricefy server. Vscan Extend – User Manual 5721203-100 Rev.
Using Vscan Extend apps Protocol Creator app The Protocol Creator app enables Vscan Extend™ users to create a customized exam script that will help guide users through an ultrasound image acquisition protocol for a Vscan Extend exam. These protocols can help increase consistency with exams by providing a list of scan planes and context-sensitive help. Automated presets for all steps and automated annotations for saved images are provided to help enhance productivity.
Using Vscan Extend Creating a new protocol (continued) 3. Enter a name for the protocol. NOTE: This step is mandatory. If you do not enter a name, an error message displays indicating to add protocol name, while trying to save the protocol or moving to the next step. 4. Enter a description about the protocol. NOTE: Entering the description is optional. NOTE: The maximum length for a protocol name and description is 50 characters. Adding a step 1. Press ADD STEP on the Create new steps screen.
Using Vscan Extend apps Adding a step (continued) 3. Select a preset for this step. Figure 5-75. Select a preset 4. Add reference images for the step. For detailed instructions on how to add reference images refer to ‘Adding reference images to a step’ on page 5-71. NOTE: Adding the refrence images is optional. 5. NOTE: Enter the user instructions for that step. Entering user instructions is optional. 6. Press “SAVE STEP” to add the created step to the protocol. Adding additional steps 1.
Using Vscan Extend Adding reference images from a PC to Vscan Extend 1. The reference images to be added to a protocol step should be uploaded to a pre-defined folder on the Vscan Extend device from a PC. NOTE: The recommended format for reference images is .mp4 and .jpeg. If you upload any other formats than .mp4 and .jpeg, the system displays an error message. 2. Connect the device to a PC via the USB cable. A pop-up message “Allow system to connect to PC.
Using Vscan Extend apps Adding reference images to a step You can add reference images to a step from a pre-defined folder having selected images. 1. Press Add reference images which takes you to a pre-populated folder having reference images used for this purpose. Figure 5-76. Add reference images 2. Select a reference image from the available images. 3. Provide a title for the reference image. The reference image could be an example of a normal or a pathology image.
Using Vscan Extend Adding reference images to a step (continued) 4. Press the delete button on the image thumbnail to remove any reference image added incorrectly to a step. Figure 5-77. Remove reference image 5. Press the empty thumbnail images for the current step. to add additional reference Multiple reference images can be added to a step. 5-72 Vscan Extend – User Manual 5721203-100 Rev.
Using Vscan Extend apps Saving the protocol 1. After you have finished adding all steps for the protocol, press Save Protocol to complete creating the protocol. Figure 5-78. Save Protocol 2. Press Menu -> Start a protocol to view the user created protocols under My Protocols. Refer to the ‘Creating a new protocol’ on page 5-67 to create additional protocols. The protocols can be edited before or after saving. Refer the ‘Edit an existing user created protocol’ on page 5-74 to edit protocols.
Using Vscan Extend Protocol Creator Settings 1. Press Menu -> Start a protocol 2. Press Settings icon on the user created protocol under My Protocols. Figure 5-79. Settings Edit an existing user created protocol 1. Press Edit button to modify the current protocol. Make the desired changes to the Protocol name or Description. 2. Press Next to add/ delete/modify protocol steps, instructions and reference content. 3. Press Save Protocol to save your changes. 5-74 Vscan Extend – User Manual 5721203-100 Rev.
Using Vscan Extend apps Deleting a protocol 1. Press Delete button to delete the protocol. Figure 5-80. Delete protocol A popup displays to confirm delete action. Figure 5-81.
Using Vscan Extend Using Protocol Creator app 1. Press Menu -> Start a protocol. Select the desired protocol under My Protocols from the protocol page. Figure 5-82. Choose protocol 2. Press START button on the Steps Overview screen to start the protocol. 5-76 NOTE: The Steps Overview screen displays only if you have enabled the checkbox under settings. If not, the protocol goes directly to the first step after selecting Start a protocol from the Menu page.
Using Vscan Extend apps Using Protocol Creator app (continued) 3. Press a step name on the Steps Overview screen. User Instructions message box displays for the step. NOTE: The User instructions display only if you have enabled the checkbox under settings. 4. Press OK on the message box to return to the scan screen. The live screen displays the following interface elements for the current protocol: • Current step name - displays the step text.
Using Vscan Extend Using Protocol Creator app (continued) • Reference - Provides access to multiple ultrasound image examples that have been attached to the current scan plane. You can access all available reference images swiping left or right. NOTE: By default the reference image tab is activated when you press the info icon for the first time. The white color in the image header represents an example of a normal image, while red color represents an example of a pathology image.
Using Vscan Extend apps Using Protocol Creator app (continued) 9. After you complete acquisition for all the steps, a message displays - Moving to session summary. Press OK. NOTE: You can swipe right to left to go to the next step, without storing the image, if you wish. In such a case, the step does not get registered as complete. You will see a red icon next to the image in the Session Completed screen. Session completed screen displays. 10. Check the status of the steps on the Session Completed screen.
Using Vscan Extend Export protocols 1. Press Settings on the protocol page. 2. Press Export this protocol. Figure 5-84. Export this protocol 3. A popup displays asking to confirm protocol export. Press Export. The protocol exports to a folder Protocol\Export on the device. Protocol export success popup message displays. Connect the device to PC and copy the exported protocol from “\Protocol\Export folder” to use on another Vscan Extend device if needed.
Using Vscan Extend apps Import protocols 1. Connect the device to a PC via the USB cable. A pop-up message “Allow system to connect to PC.Further interaction with device is blocked” displays. Press Allow to connect. 2. Create a folder named “Protocol” on the device in the following path, if not already created. Computer\Pixel V2+\Phone storage\Protocol 3. Create another folder named “Import” under the “Protocol” folder, if not already created. 4. Copy the specific protocol into Import folder on the device.
Using Vscan Extend Scan Coach RHD app Scan Coach module for Rheumatic Heart Disease (RHD) evaluation provides a protocol of standard ultrasound imaging views and context-based reference materials to perform a systematic evaluation for presence of RHD. During the exam, users will have access to a reference ultrasound image of normal anatomy and examples of common pathologies for each scan plane. The steps overview page provides a checklist of views defined by the protocol to track completion during the exam.
Using Vscan Extend apps Scan Coach RHD protocol During the exam, users can access examples of reference ultrasound images of normal anatomy and some common pathologies for individual scan planes. Animations are available to demonstrate the relationship of the probe position with the resulting ultrasound image. Annotated schematics with anatomical landmarks provide additional reference. A protocol step status provides a checklist of views defined by the protocol to track completion during the exam.
Using Vscan Extend Scan Coach RHD settings (continued) • Steps overview page - displays the list of steps for the RHD protocol prior to the exam as listed in Table 5-5 Table 5-5: Step Number 5-84 List of Steps Description 1) Parasternal Long - 2D 2) Parasternal Long - MV thickness 3) Parasternal Long - Color 4) Parasternal Long - MR jet length 5) Parasternal Long - AR jet length 6) Parasternal Short - 2D 7) Ap 4 and 5 chamber - 2D 8) Ap 4 chamber – MV Color 9) Ap 5 chamber – AoV Color
Using Vscan Extend apps Using Scan Coach RHD app 1. Press Menu -> Start a protocol. Select the Scan Coach RHD protocol from the protocol page. 2. Press START button on the Steps Overview screen to start the protocol. OR Press a step name on the Steps Overview screen to start the protocol from that step Figure 5-87. Steps overview Vscan Extend – User Manual 5721203-100 Rev.
Using Vscan Extend Using Scan Coach RHD app (continued) User Instructions message box displays for the step. 3. Press OK on the message box to navigate to the scan screen. NOTE: The Steps Overview screen and User instructions display only if you have enabled them from the settings. If not enabled, the protocol goes directly to the first step after selecting Start a protocol from the Menu page. Figure 5-88. 5-86 User instructions Vscan Extend – User Manual 5721203-100 Rev.
Using Vscan Extend apps Using Scan Coach RHD app (continued) The live scan screen displays the following interface elements for the current protocol: Figure 5-89. Interface elements 1. Current step name - displays the step text. For example, Parasternal Long Axis 2. Step number - displays previous (for example 3), current (4) and next step numbers (5) 3. Info icon - invokes Scan Coach help windows for current step Vscan Extend – User Manual 5721203-100 Rev.
Using Vscan Extend Using Scan Coach RHD app (continued) 4. Press the Info (i’) icon to access Scan Coach reference help for the current step. Scan Coach reference window displays with three tabs Reference, Position and Steps. • NOTE: Reference - Provides access to multiple ultrasound image examples for normal view and a few common pathologies for the current scan plane. You can access all available reference images swiping left or right.
Using Vscan Extend apps Using Scan Coach RHD app (continued) Figure 5-91. NOTE: Vscan Extend – User Manual 5721203-100 Rev. 13 Reference Image Pathology When you toggle between Scan Coach window and the live scan screen, the system remembers and displays the last seen Scan Coach tab.
Using Vscan Extend Using Scan Coach RHD app (continued) • Position - Provides access to animations showing probe position with schematic representation and annotation of the corresponding reference images for the current scan plane. You can access multiple animations for the step through the gallery. Figure 5-92. • NOTE: Steps - checklist of all steps showing the completion status for each step. A thumbnail of the saved image and a green dot indicates the completion status of the step. Figure 5-93.
Using Vscan Extend apps Using Scan Coach RHD app (continued) 5. Press button to exit the Scan Coach windows and Steps to go back to the scan screen. You can access Scan Coach reference content from the following screens: • 2D or Color mode - live scan screen • 2D or Color mode - frozen image screen • Measurement screen 6. Once you acquire an image for the current step, press Store. The stored image shows the current step name. The red dot next to the step turns green on the Steps Overview page. 7.
Using Vscan Extend Using Scan Coach RHD app (continued) 10. After you complete acquisition for all the steps, a message displays - Moving to session summary. Press OK. 11. Session completed screen displays. Figure 5-94. Session complete 12. Check the status of the steps on the Session Completed screen. 13. If an incomplete step is identified, press to select that scan plane to navigate directly to complete if desired or press Exit Protocol if the exam is complete. 14.
Using Vscan Extend apps Using Scan Coach RHD app (continued) NOTE: If you wish to stop the protocol anytime in the middle of a scan, press the Menu icon on the header. Press “Stop current protocol” to exit. Figure 5-95. Stop protocol Vscan Extend – User Manual 5721203-100 Rev.
Using Vscan Extend Scan Coach FATE app The Scan Coach module for Focused Assessment Transthoracic Echo (FATE) provides a protocol of standard ultrasound imaging views and context-based reference materials to perform a systematic FATE exam. During the exam, users will have access to a reference ultrasound image of normal anatomy and examples of common pathologies for each scan plane.
Using Vscan Extend apps Scan Coach FATE protocol During the exam, users can access examples of reference ultrasound images of normal anatomy and some common pathologies for individual scan planes. Animations are available to demonstrate the relationship of the probe position with the resulting ultrasound image. Annotated schematics with anatomical landmarks provide additional reference. A protocol step status provides a checklist of views defined by the protocol to track completion during the exam.
Using Vscan Extend Scan Coach FATE settings 1. Press Start a protocol from the Menu screen. 2. Press Scan Coach FATE protocol settings icon to choose the desired settings. Figure 5-96.
Using Vscan Extend apps Using Scan Coach FATE app 1. Press Menu -> Start a protocol. Select the Scan Coach FATE protocol from the protocol page. 2. Press START button on the Steps Overview screen to start the protocol. OR Press a step name on the Steps Overview screen to start the protocol from that step Figure 5-97. Steps overview Vscan Extend – User Manual 5721203-100 Rev.
Using Vscan Extend Using Scan Coach FATE app (continued) 3. User Instructions message box displays for the step. 4. Press OK on the message box to navigate to the scan screen. NOTE: The Steps Overview screen and User instructions display only if you have enabled them from the settings. If not enabled, the protocol goes directly to the first step after selecting Start a protocol from the Menu page. Figure 5-98. 5-98 User instructions Vscan Extend – User Manual 5721203-100 Rev.
Using Vscan Extend apps Using Scan Coach FATE app (continued) The live scan screen displays the following interface elements for the current protocol: Figure 5-99. Interface elements 1. Current step name - displays the step text. For example, Parasternal Long - B mode 2. Step number - displays previous (for example 2), current (3) and next step numbers (4) 3. Info icon - invokes Scan Coach help windows for current step Vscan Extend – User Manual 5721203-100 Rev.
Using Vscan Extend Using Scan Coach FATE app (continued) 5. Press the Info (i’) icon to access Scan Coach reference help for the current step. Scan Coach reference window displays with three tabs Reference, Position and Steps. • NOTE: Reference - Provides access to multiple ultrasound image examples for normal view and a few common pathologies for the current scan plane. You can access all available reference images swiping left or right.
Using Vscan Extend apps Using Scan Coach FATE app (continued) Figure 5-101. NOTE: Vscan Extend – User Manual 5721203-100 Rev. 13 Reference Image Pathology When you toggle between Scan Coach window and the live scan screen, the system remembers and displays the last seen Scan Coach tab.
Using Vscan Extend Using Scan Coach FATE app (continued) • Position - Provides access to animations showing probe position with schematic representation and annotation of the corresponding reference images for the current scan plane. You can access multiple animations for the step through the gallery. Figure 5-102. 5-102 Position Vscan Extend – User Manual 5721203-100 Rev.
Using Vscan Extend apps Using Scan Coach FATE app (continued) • NOTE: Steps - checklist of all steps showing the completion status for each step. A green dot next to the thumbnail of the saved image indicates the completion status of the step. Figure 5-103. Steps 6. Press button to exit the Scan Coach windows and Steps to go back to the scan screen.
Using Vscan Extend Using Scan Coach FATE app (continued) 8. Enter the storage PIN when you store the image for the first time. NOTE: 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.
Using Vscan Extend apps Using Scan Coach FATE app (continued) Session completed screen displays. Figure 5-104. Session complete 12. Check the status of the steps on the Session Completed screen. 13. You could navigate directly to an incomplete step to acquire a missing view or you can Exit Protocol if the scan is complete. 14. Press Exit on the Confirmation Pop-up message to quit the protocol. OR Press Cancel to update captures. Vscan Extend – User Manual 5721203-100 Rev.
Using Vscan Extend Using Scan Coach FATE app (continued) NOTE: If you wish to stop the protocol anytime in the middle of a scan, press the Menu icon on the header. Press “Stop current protocol” to exit. Figure 5-105. 5-106 Stop protocol Vscan Extend – User Manual 5721203-100 Rev.
Using Vscan Extend apps Scan Coach FCU app Scan Coach module for Focused Cardiac Ultrasound (FCU) evaluation provides a protocol of standard ultrasound imaging views and context-based reference materials to perform a systematic evaluation of the heart. During the exam, users will have access to a reference ultrasound image of normal anatomy and examples of common pathologies for each scan plane.
Using Vscan Extend Scan Coach FCU protocol During the exam, users can access examples of reference ultrasound images of normal anatomy and some common pathologies for individual scan planes. Animations are available to demonstrate the relationship of the probe position with the resulting ultrasound image. Annotated schematics with anatomical landmarks provide additional reference. A protocol step status provides a checklist of views defined by the protocol to track completion during the exam.
Using Vscan Extend apps Scan Coach FCU settings (continued) Click the desired checkboxes to set up the system to your preferences: • Soft key hints - shows user instructions hints for this protocol • User instructions - shows instruction for the particular step • Steps overview page - displays the list of steps for the FCU protocol prior to the exam as listed in Table 5-7 Table 5-7: List of Steps Step Number Description 1) Parasternal Long Axis 2) Parasternal Short Axis 3) Apical 4-Ch 4) Api
Using Vscan Extend Using Scan Coach FCU app 1. Press Menu -> Start a protocol. Select the Scan Coach FCU protocol from the protocol page. 2. Press START button on the Steps Overview screen to start the protocol. OR Press a step name on the Steps Overview screen to start the protocol from that step. Figure 5-107. Steps overview 3. User Instructions message box displays for the step. 4. Press OK on the message box to navigate to the scan screen. 5-110 Vscan Extend – User Manual 5721203-100 Rev.
Using Vscan Extend apps Using Scan Coach FCU app (continued) NOTE: The Steps Overview screen and User instructions display only if you have enabled them from the settings. If not enabled, the protocol goes directly to the first step after selecting Start a protocol from the Menu page. Figure 5-108. User instructions 5. The live scan screen displays the following interface elements for the current protocol: Figure 5-109. Interface elements 1. Current step name - displays the step text.
Using Vscan Extend Using Scan Coach FCU app (continued) 6. Press the Info (i’) icon to access Scan Coach reference help for the current step. Scan Coach reference window displays with three tabs Reference, Position and Steps. • NOTE: Reference - Provides access to multiple ultrasound image examples for normal view and a few common pathologies for the current scan plane. You can access all available reference images swiping left or right.
Using Vscan Extend apps Using Scan Coach FCU app (continued) Figure 5-111. NOTE: Reference image Pathology When you toggle between Scan Coach window and the live scan screen, the system remembers and displays the last seen Scan Coach tab. • Position - Provides access to animations showing probe position with schematic representation and annotation of the corresponding reference images for the current scan plane. You can access multiple animations for the step through the gallery. Figure 5-112.
Using Vscan Extend Using Scan Coach FCU app (continued) • NOTE: Steps - checklist of all steps showing the completion status for each step. A green dot next to the thumbnail of the saved image indicates the completion status of the step. Figure 5-113. Steps 7. Press button to exit the Scan Coach windows and Steps to go back to the scan screen.
Using Vscan Extend apps Using Scan Coach FCU app (continued) 9. Enter the storage PIN when you store the image for the first time. NOTE: 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.
Using Vscan Extend Using Scan Coach FCU app (continued) 14. Check the status of the steps on the Session Completed screen. 15. You could navigate directly to an incomplete step to acquire a missing view or can Exit Protocol if the scan is complete. 16. Press Exit on the Confirmation Pop-up message to quit the protocol OR Press Cancel to update captures. NOTE: If you wish to stop the protocol anytime in the middle of a scan, press the Menu icon on the header. Press “Stop current protocol” to exit.
Using Vscan Extend apps LVivo EF app The LVivo EF app enables an automated edge detection of left myocardial wall and calculates end-systolic, end-diastolic left ventricular volumes and ejection fraction using apical 4-chamber views. This app has been developed by and licensed from DiA Imaging Analysis Ltd. The LVivo EF app uses only a single plane (apical 4-chamber) view to calculate Ejection Fraction (EF).
Using Vscan Extend Using LVivo EF app (continued) • Depth - Proportion of left ventricle (LV) to left atrium (LA) will be 2/3-1/3 (Optimum depth will be 14-18 cm). • Avoid foreshortening of the apex. Figure 5-116. LVivo EF measurement guideline CAUTION 5-118 Correct border tracking is important for an accurate EF measurement. If the image acquisition guidelines are not followed or the image has too much noise (e.g.
Using Vscan Extend apps Using LVivo EF app (continued) 3. Freeze the 4 chamber view immediately after visualizing the heart cycle to be measured. Figure 5-117. LVivo EF app 4. Press LVivo EF icon to start the calculation. Figure 5-118. 1. 2. 3. 4. LVivo EF measurement Border Measurement results Accept & Store button Close button Vscan Extend – User Manual 5721203-100 Rev.
Using Vscan Extend Using LVivo EF app (continued) 5. LVivo EF app automatically traces the LV contours and draws a border around it. 6. End-Diastolic Volume (EDV), End-Systolic Volume (ESV) and Ejection Fraction (EF) values are calculated and displayed on the screen. 7. Press “Accept and store” to save the cine clip with measurement results.
Using Vscan Extend apps Using LVivo EF app (continued) 9. Error conditions – Error messages will be displayed instead of border tracing and calculations under the following conditions: • If a complete heart cycle with end-diastolic and end-systolic frames is not detected. Length of cycle or clip orientation not optimal. Retry. • If Image quality is not optimal for the app to track at least 2/3 of the endocardial borders. Image quality not optimal. Retry.
Using Vscan Extend Additional reference information Accuracy for EF and volumes has been determined by comparing the results obtained by LVivo EF to an average of readings obtained by manual tracing of the same clip by 4 expert sonographers. The manual measurements were performed on the Echo PAC clinical workstation using Mod. Simpson's method for single plane.
Using Vscan Extend apps Lung M-Mode app The Lung M-mode app provides the m-mode capability specifically to support the assessment of lung and documentation of signs like seashore. After entering this lung m-mode tool, a centered vertical m-mode cursor line will be applied to generate the anatomical m-mode display. Such tool will be enabled for linear transducer with lung preset and sector transducer with cardiac preset (the recommended preset for lung assessment with the sector transducer).
Using Vscan Extend Using Lung M-Mode app (continued) 1. Press the M-mode icon. A centered vertical M-mode cursor line appears. Figure 5-120. M-mode cursor 2. Press M mode icon again to enter full M-mode display. Figure 5-121. M-mode image The image freezes automatically once the M-mode display fills. Alternatively an indicator line is seen after 10 seconds of display filling. Also the image can be freezed manually. 5-124 Vscan Extend – User Manual 5721203-100 Rev.
Using Vscan Extend apps Using Lung M-Mode app (continued) 3. Vertical measurements can be performed on the M-mode image by pressing the Distance icon. 4. Press Distance icon. Figure 5-122. Distance measurement 5. Press Store icon to save the M-mode image to the gallery. NOTE: M-Mode still frame images can be saved, not videos.You can not play or pause once the M-mode image is acquired. 6. Close button can be pressed at any point to exit M-mode and go back to live 2D imaging.
Using Vscan Extend Screen Mirror app Screen Mirror app is used to mirror the display of the Vscan Extend™ device onto wireless displays in the vicinity via Miracast®. By the help of the Screen Mirror app, the user can choose from a list of wireless displays in the vicinity, initiate a connection, mirror the screen and disconnect from the wireless display. Once connected, the content of the Vscan Extend’s screen is mirrored on to the larger display.
Using Vscan Extend apps Using Screen mirror app To start screen sharing 1. Press Menu -> Settings -> Screen Mirror Figure 5-123. Screen Mirror screen 2. Press Screen Mirror to initiate mirroring of the Vscan Extend screen. Figure 5-124. Select a device 3. Select a device. A connection establishes between the device and Vscan Extend. The Vscan Extend screen is mirrored. 4. Press the Back arrow to go the scan screen. Vscan Extend – User Manual 5721203-100 Rev.
Using Vscan Extend To stop screen sharing 1. Press Menu -> Settings -> Screen Mirror 2. Press the device name on the list. Figure 5-125. Device name A popup displays prompting you to disconnect. 3. Press Disconnect. Figure 5-126. Disconnect The mirroring ends. NOTE: 5-128 You must press Menu -> Settings -> Screen Mirror. Select the device and press disconnect to end mirroring each time the device is mirrored. Vscan Extend – User Manual 5721203-100 Rev.
Using Vscan Extend apps Enterprise Archive Uplink app The Enterprise Archive Uplink app provides the interface to GE’s Centricity Enterprise Archive™, a vendor neutral archive solution for both DICOM® and non-DICOM content. The Enterprise Archive Uplink app enables a secure export of Vscan Extend ultrasound DICOM images to Centricity Enterprise Archive via the DICOMweb™ standard STOW-RS. Centricity Enterprise Archive needs to be purchased separately.
Using Vscan Extend Configuring the Enterprise Archive Uplink (EA) To configure EA as image server: 1. Press image server tab from server settings. 2. Press Add icon and enter server name and then select Type as Enterprise Archive. Figure 5-127. Add EA as image server 3. Enter a url name of the configuration website, user name and password. 4. Press Activate button. An activation successful pop-up appears, if the activation is success. Press Ok. 5. Press Verify button.
Using Vscan Extend apps Configuring the Enterprise Archive Uplink (EA) (continued) Figure 5-128. Verify EA image server 6. Press Add button to add the server. Figure 5-129. Add server You can verify the connectivity with the DICOMweb STOW-RS service. You can choose to set Enterprise Archive link as favorite. Refer to ‘Configure Image Server’ on page 4-9 to set EA as favorite. NOTE: Once the app is installed, EA image server is available as a new storage destination.
Using Vscan Extend Using EA Uplink Export images to the EA server via Menu -> Exams -> Export. NOTE: Refer to ‘DICOM Store: exporting DICOM images from Vscan Extend to DICOM image server’ on page 5-41 and follow the steps to export images. NOTE: If several storage destinations are configured, select the desired destination, in this case, the EA server. Figure 5-130. 5-132 Select EA server Vscan Extend – User Manual 5721203-100 Rev.
Using Vscan Extend apps Comprehensive Label app Wirelessly exported jpg files and mpg clips will be complemented by patient identifier and scan information as suggested by ultrasound documentation standards (e.g. AIUM, DEGUM). Linked patient name, patient ID, date of birth, exam date, exam number, transducer name, chosen preset, transmit frequency, MI and TI, transmit focus point, and facility name will be part of exported image or clip.
Using Vscan Extend Export images through Windows Share 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 shown in the Figure below. Figure 5-132. Figure 5-133. 5-134 Exported image folder Images inside the Exam folder Vscan Extend – User Manual 5721203-100 Rev.
Using Vscan Extend apps Export images through Windows Share (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. 6. The exported image with Exam information is shown in the figure below Figure 5-134. Vscan Extend – User Manual 5721203-100 Rev.
Using Vscan Extend Auto Optimize app Auto Optimize enables automated TGC (time gain compensation) with a single key stroke during live scanning. Accordingly, gain will be automatically adjusted for all depths. Auto Optimize is not available for ophthalmic scanning. NOTE: * Applications under GE Marketplace are available as options (not available in all geographies). Activating Auto TGC feature 5-136 • Gain increases or decreases the amount of echo information displayed in an image.
Using Vscan Extend apps AV Plane app The AV Plane app enables an automated measurement of atrioventricular (AV) plane displacement. The measurement tool is based on automated tracking of AV plane and calculates septal, lateral and mean systolic displacement. NOTE: This app works only with the sector probe. NOTE: * Applications under GE Marketplace are available as options (not available in all geographies).
Using Vscan Extend Using AV Plane app (continued) • Press AV Plane icon to enter annular displacement measurement. Figure 5-136. AV Plane measurement 1. 2. 3. 4. Mitral annular plane Measurement results Store button Close button A line representing mitral annular plane is tracked for the whole heart cycle. • The AV Plane app finds the mitral annular excursion with respect to probe surface. Septal, lateral and mean of mitral annular excursion values display on the image screen.
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 6-16 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 Using Germicides 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 device.
Vscan Extend Maintenance Cleaning agents Follow the instructions described below while using CaviWipes. 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 of the pre-cleaned 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 6-2). 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. Backup patient data. To perform a software upgrade: 1. Remove the battery. See ‘Inserting/removing the battery’ on page 3-23 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. 8. Once the upgrade is complete, power OFF the Vcan Extend. 9. Remove the battery, remove the microSD card (MST and Application software SD card). 10. Insert the original microSD card containing the log files. 11. Insert the battery. 12.
Vscan Extend Maintenance Upgrade MST firmware Perform MST firmware upgrade as recommended by GE personnel. Before starting the MST firmware upgrade 1. Record the option key. (Press Settings -> Configuration -> View Modules -> Enter a key to note the option key) 2. Power off the Vscan Extend. 3. Make sure the battery is fully charged. 4. Remove the battery. See ‘To remove the battery’ on page 3-23 for more information. 5. Remove the original microSD card present in the Vscan Extend. 6.
Upgrade software Upgrade MST firmware (continued) After the firmware upgrade is completed 1. Disconnect the AC/DC adapter if connected to the device. NOTE: If the AC/DC adapter is not disconnected, the device activation does not get initiated. The device remains in the blue screen. 2. Remove the battery. 3. Remove the MST and Application software SD card from the Vscan Extend. 4. Insert the original microSD card into the Vscan Extend. 5. Insert the battery. 6. Power on the Vscan Extend.
Vscan Extend Maintenance Troubleshooting Table 6-2: Problem Troubleshooting Possible cause Solution Vscan Extend has no power. When both batteries are discharged. Connect the AC/DC adapter to charge the device for at least 10 minutes and power on the device. Vscan Extend is not charging. Battery not inserted. Insert battery (see page 3-23) Battery defect or end of life. Contact GE Service (see page 1-11) Broken battery connection.
Troubleshooting Table 6-2: Problem Vscan Extend is not entering the scan screen and stays on the GE start-up screen. Troubleshooting (Continued) Possible cause Solution Battery may not have sufficient charge. Charge the Vscan Extend battery for at least 60 minutes. Battery is not inserted properly. Remove and insert the battery to ensure the battery sits flat after assembly.
Vscan Extend Maintenance System shutdown error If the shutdown screen appears after 50 seconds on booting. Message displayed - Battery critically low: • Connect charger immediately (amber LED indicates the device is charging). • Power off Vscan Extend, wait 1 minute, allow the device to shut down properly, and Power ON Vscan Extend. Figure 6-5. Shutdown error If the problem persists: 6-18 • Allow the device to shut down properly (wait for 30 seconds). • Remove the battery.
Troubleshooting Additional messages Table 6-3: DICOM messages User message Remarks User Rejection The proposed presentation context is rejected by the Service Class Provider (SCP) (DICOM End Point). Contact Hospital IT team. No Reason Initiated DICOM transaction from Vscan Extend is rejected by the SCP. Contact Hospital IT team for more details. Device logs may help find the reason. Abstract syntax not supported. SCP does not support the DICOM Service (Abstract Syntax) initiated by the device.
Vscan Extend Maintenance Table 6-3: DICOM messages User message Remarks Association request failed (or never connected). Request to connect to DICOM Server failed. Contact Hospital IT team. Network timeout error Check network connection. Contact Hospital IT team. Peer aborted association Repeat the DICOM transaction. If it consistently fails, contact GE Service. No network connection Check network connection. Contact Hospital IT team.
Troubleshooting 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 critically low. WARNING Connect charger immediately • WARNING System voltage critical System voltage is at critical level and will shut down. If the problem persists, contact GE service.
Vscan Extend Maintenance System Warning Messages (continued) • Connectivity error Unable to connect WARNING Check your internet connection and try again System messages • Perform system backup System internal memory usage reached 45%. WARNING Perform system backup. • 6-22 Scanning not allowed WARNING Scanning is not allowed when AC is connected. WARNING Scanning is not allowed when connected to a PC. Vscan Extend – User Manual 5721203-100 Rev.
Troubleshooting Before sending the Vscan Extend to the Repair Depot The user MUST perform data backup (‘Backup’ on page 5-44) and erase data before the device is sent to the Repair Depot. To erase the data: 1. Press Menu -> Settings -> Admin settings -> Enter the Admin PIN -> Settings 2. Navigate to Apps 3. Select VscanExtend (Scanner App). Press Clear Data 4. Press Back arrow 5. Press Home -> Select Launcher 6. Press Back arrow 7. Press Kiosk Settings on the Dashboard. Press Reset Kiosk.
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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 • Display unit (with battery, without probe): 168 x 76 x 22 mm, 321 gram • Display: 5 inches, 720 x 1280 pixels resolution • Sector probe: 129 x 32 x 25 mm, 85 gram • Dual Probe: 129 x 39 x 28 mm, 120 gram • Battery: 91 x 56 x 9 mm, 65 gram Phased array transducer for deep scanning • Field-of-view for black and white imaging: up to 70 degrees with maximum depth of 24 cm • The color flow sector represents blood flow within an angle of 40 degrees.
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. Phased array transducer - black/white 7-6 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. Phased array transducer - black/white 7-10 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.
Chapter 8 Privacy and Security Contents ‘Introduction’ on page 8-2 ‘Privacy and Security Environment Requirements’ 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 8-19 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 Requirements 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.
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.
Network Connectivity System interconnections (continued) Device features • Supported Wireless Protocols include WPA2 with PSK and EAP with certificates • Log files • Data backup/restore • Security and software updates 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 (only 2.4 GHz): 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 Table 8-3: Local port Any Remote port 5555/53 Outbound Firewall configuration Protocol TCP Programs Wi-Fi connection Recommended configuration of network infrastructure Windows 2 Port 104 or another port configured for the DICOM Storage service. 3 Port 104 or another port configured for the DICOM Query service. 4 Port 104 or another port configured for the DICOM Worklist service. 8-12 Network service DNS /Wi-Fi Vscan Extend – User Manual 5721203-100 Rev.
Information Protection 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.
Privacy and Security 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. WPA/WPA2 PSK 2. 802.
Information Protection 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.
Privacy and Security 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.
Business Continuity Securing data on Remote Archive and DICOM/PACS servers If external archive is used, a backup procedure must be established for the external archive. The business contingency planning of data stored on DICOM/PACS servers is outside the scope of this document. Off-line mode The Vscan Extend can operate in stand-alone mode, with the use of Local Archive.
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. Even though the Vscan Extend supports PI collection for treatment or healthcare operations, the system might support collection of more data than is needed for a particular installation. Limit the PI collection to the content needed.
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. 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.
Privacy and Security 8-24 Vscan Extend – User Manual 5721203-100 Rev.
Index A I Activating Auto TGC feature, 5-136 Activating Wi Fi, 4-27 Appendix, 7-1 Audit logs audit logs, 5-31 Auto EF app, 5-117 Auto freeze, 5-23 Auto Optimize app, 5-136 AutoCycle, 5-23 AV Plane, 5-137 Indication for use, 1-4, 1-5 Information Requesting, 1-11 Inspection, 6-3 B M Battery Charge, 3-18 Level indicator, 3-22 Removing / inserting the battery (VE-BAT), 3-23 specifications, 3-24 Black and white imaging, 5-17 Bladder Volume Bladder Volume, 5-50 Measurements, 5-24 C Certificate Authority,
Scanning, 5-2 Screen Mirror app, 5-126 Settings, 4-2 Software Update, 4-15 System description, 3-6 T Tricefy Uplink app, 5-64 Troubleshooting, 6-16 U Upgrade application software, 6-12 Using Vscan Extend, 5-1 Using Vscan Extend apps, 5-49 V Voltage requirements, 3-20 Vscan Extend Battery, 3-18 Vscan Extend Maintenance, 6-1 Vscan Extend Settings, 4-1 W Windows Share, 5-33 Index-2 Vscan Extend – User Manual 5721203-100 Rev.
