GE Vscan Extend User Manual
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GE Vscan Extend User Manual

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Technical Publications
Vscan Extend™
Version 1.0
User Manual
5721203-100 — English
Rev. D
Operating Documentation
Copyright © 2016 By General Electric Co.

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Summary of Contents for GE Vscan Extend

  • Page 1 Technical Publications Vscan Extend™ Version 1.0 User Manual 5721203-100 — English Rev. D Operating Documentation Copyright © 2016 By General Electric Co.
  • Page 2 This product complies with regulatory requirements of the following European Directive 93/42/EEC concerning medical devices. This manual is a reference for the Vscan Extend. It applies to all versions of the 1.0 software for the Vscan Extend ultrasound system. Manufacturer:...
  • Page 3 (GE electronic Product Data Management). If you need to know the latest revision, contact your distributor, local GE Sales Representative or in the USA call the GE Ultrasound Clinical Answer Center at 1 800 682 5327 or 1 262 524 5698.
  • Page 4 This page intentionally left blank. – Vscan Extend User Manual 5721203-100 Rev. D...
  • Page 5 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.

  • Page 6: Certifications

    IEC* 60601-1-12 Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment * including national deviations Certifications • GE Vingmed Ultrasound is ISO 13485 certified. – Vscan Extend User Manual 5721203-100 Rev. D...

  • Page 7: 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.

  • Page 8: Country Specific Approval

    – Ophthalmalic • JAPAN The following optional feature IS NOT available in JAPAN: DANGER – Ophthalmalic • CHINA The following optional feature IS NOT available in CHINA: DANGER – Ophthalmalic Importer Information Turkey – Vscan Extend User Manual 5721203-100 Rev. D...

  • Page 9: Table Of Contents

    Contact Information Contacting GE Ultrasound - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-10 Global ultrasound support center phone numbers - - - - - - - - - - - - - - - 1-11 Manufacturer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-14 Chapter 2 —...
  • Page 10 Power on/off- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-22 Vscan Extend activation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-24 Chapter 4 —...
  • Page 11 Troubleshooting Vscan Extend troubleshooting - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-14 System Warning Messages - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-16 Chapter 7 —...
  • Page 12 How to contact GE - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -...
  • Page 13 Chapter 1 Introduction Contents: ‘Overview’ on page 1-2 ‘Warnings’ on page 1-7 ‘Contact Information’ on page 1-10 – Vscan Extend User Manual 5721203-100 Rev. D...

  • Page 14: Overview

    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 Extend configured with a sector probe allowing deep scanning (holding the phased array transducer G3S) •...

  • Page 15: Principles Of Operation

    Periodically review the procedures for operation and safety precautions. 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.

  • Page 16: Indications For Use (For All Countries Except Usa, China And Japan)

    MUST only be used with the linear functionality of the Dual Probe. If the Vscan Extend purchased does NOT have the Ophthalmic preset option, DO NOT use for ophthalmic use or any use causing the acoustic beam to pass through the eye.

  • Page 17: Indications For Use (For Usa, China And Japan)

    Fluid; Thoracic/Lung (e.g. pleural motion/sliding, line artifacts); and Pediatrics. Contraindication for use (for USA, China and Japan) The Vscan Extend ultrasound device is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye.

  • Page 18: Intended Users

    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. The list of the potential users includes but is not...

  • Page 19: Warnings

    To prevent damage of the equipment or injury to yourself or others, read the following safety warnings before using Vscan Extend. • Vscan Extend is a precision instrument. Handle Vscan WARNING Extend and its accessories with care. Do not subject Vscan Extend to mechanical shock or impact.
  • Page 20 Do not rub your eyes! • If battery fluid gets onto your skin or clothing, immediately use clean water to wash off the battery fluid. – Vscan Extend User Manual 5721203-100 Rev. D...
  • Page 21 Do not charge or use the battery if it appears to be damaged or leaking. • Charge the battery only in a Vscan Extend device or in the Vscan Extend battery charger. Be sure to follow all instructions that are provided with the battery charger.

  • Page 22: Contact Information

    Introduction Contact Information Contacting GE Ultrasound For additional information or assistance, please contact your local distributor or the appropriate support resource listed on the following pages: Internet https://vscan.gehealthcare.com http://www.gehealthcare.com TEL: (1) 800-437-1171 Ultrasound Service Engineering 9900 Innovation Drive Wauwatosa, WI 53226 Clinical Questions Please contact your local Applications or Sales Representative.

  • Page 23: Global Ultrasound Support Center Phone Numbers

    0800 3331984 Chile 0800 367000 For USA only: when contacting GE CARES you will have to provide your system ID. If system ID is unknown, please give the Temporary System ID “Vscan Extend” to be properly routed for support. –...
  • Page 24 Italy South 800 827170 Liechtenstein 0041 44 809 9293 Monaco 0800139140 Netherlands 8000994442 Northern Ireland 08000720248 Norway 80062043 Portugal 800 834 004 Russia +7 495 739 69 75 San Marino 800 827168 1-12 – Vscan Extend User Manual 5721203-100 Rev. D...
  • Page 25 Saudi Arabia 800 1243002 South Africa 800 111 671 Spain 902 400 246 Sweden 0201201436 Switzerland 0800556958 Turkey Contact local distributor 800 3646 0845 8503392 Ukraine +38 044 391 37 56 (57) – 1-13 Vscan Extend User Manual 5721203-100 Rev. D...

  • Page 26: Manufacturer

    Contact local distributor Laos Contact local distributor Brunei Darussalam Contact local distributor Cambodia Contact local distributor Manufacturer GE VINGMED ULTRASOUND A/S Strandpromenaden 45 3191 Horten, Norway TEL: (+47) 3302 1100; FAX: (+47) 3302 1350 1-14 – Vscan Extend User Manual...
  • Page 27 Chapter 2 Safety Contents: ‘Introduction’ on page 2-2 ‘Owner responsibility’ on page 2-3 ‘Important safety considerations’ on page 2-5 ‘Maximum probe temperature’ on page 2-24 ‘Device labels and symbols’ on page 2-25 – Vscan Extend User Manual 5721203-100 Rev. D...

  • Page 28: 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...

  • Page 29: Owner Responsibility

    It is advisable to maintain a list of authorized operators. Should the system fail to operate correctly, or if Vscan Extend does not respond to the commands described in this manual, the operator should contact the nearest field GE Ultrasound Service Office.

  • Page 30: Notice Against User Modification

    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.

  • Page 31: Important Safety Considerations

    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.

  • Page 32: Diagnostic Information

    Avoid analyzing data from small viewing angles. General precautionary advice for the use of diagnostic ultrasound in combination with ultrasound contrast agents The Vscan Extend is not intended to be used with a contrast CAUTION agent. Cardiac rhythm disturbances during cardiac studies using gas ultrasound contrast agents have been observed in the diagnostic range of Mechanical Index (MI) values.

  • Page 33: Electrical Hazard

    • If flammable substances are detected after the system has been turned on, do not attempt to turn off the Vscan Extend, or to unplug it. • If flammable substances are detected, evacuate and ventilate the area before turning off Vscan Extend.

  • Page 34: Electrical Hazard

    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. •...
  • Page 35 Connection to a PC can be done when the PC is in compliance CAUTION 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).

  • Page 36: Electromagnetic Compatibility (Emc)

    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. 2-10 – Vscan Extend User Manual 5721203-100 Rev. D...
  • Page 37 This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. – 2-11 Vscan Extend User Manual 5721203-100 Rev. D...
  • Page 38 1. l'appareil ne doit pas produire de brouillage, et 2. l'utilisateur de l'appareil doit accepter tout brouillage adioélectrique subi, même si le brouillage est susceptible d'en compromettre le fonctionnement. 2-12 – Vscan Extend User Manual 5721203-100 Rev. D...
  • Page 39 Pour obtenir de l’aide, contacter le vendeur ou un technician radio/télévision expérimenté. REMARQUE : Toute modifi cation non autorisée expressément par le fabricant responsable de la conformité peut annuler le droit de l’utilisateur à faire fonctionner le produit. – 2-13 Vscan Extend User Manual 5721203-100 Rev. D...

  • Page 40: Electromagnetic Emissions

    Electromagnetic immunity (Part 1) Guidance and manufacturer’s declaration – electromagnetic immunity. The Vscan Extend is intended for use in the electromagnetic environment below. The customer or the user of the Vscan Extend should assure that it is used in such an environment. Electromagnetic EN 60601 environment –...
  • Page 41 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. Electromagnetic EN 60601 environment –...
  • Page 42 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.
  • Page 43 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.

  • Page 44: Separation Distances

    NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 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.

  • Page 45: Acoustic Output

    The Ispta is the Spatial Peak Temporal Average Intensity. The absolute maximum limit of Ispta is 720 mW/cm as set by the FDA guidance of September 9, 2008 for diagnostic ultrasound systems and transducers. – 2-19 Vscan Extend User Manual 5721203-100 Rev. D...
  • Page 46 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/cm...
  • Page 47 References • The British Medical Ultrasound Society. Guidelines for the safe use of diagnostic ultrasound equipment. • American Institute of Ultrasound in Medicine Consensus Report on Potential Bioeffects of Diagnostic Ultrasound. – 2-21 Vscan Extend User Manual 5721203-100 Rev. D...
  • Page 48 ALARA principles, and examples of specific applications of the ALARA principle. 2-22 – Vscan Extend User Manual 5721203-100 Rev. D...

  • Page 49: Environmental Protection

    The equipment must not be disposed of as unsorted municipal waste nor be destroyed by incineration. It must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment. – 2-23 Vscan Extend User Manual 5721203-100 Rev. D...

  • Page 50: Maximum Probe Temperature

    Maximum probe temperature Max Temp in deg C Max Temp in deg C Probe (Simulated use) (Still air) Vscan Extend – configured with Sector probe: 39.7 43.1 Phased array transducer (G3S) for Deep scanning Vscan Extend – configured with Dual probe: 42.6 Phased array transducer (G3S) for Deep scanning Vscan Extend –...

  • Page 51: Device Labels And Symbols

    Device labels and symbols Device labels and symbols Vscan Extend Labels (Example) Figure 2-2. Vscan Extend rating label 1. Rating label 2. Inner label 3. UDI label - contains UDI information 4. Serial number label - contains device serial number NOTE: The label shown in Figure 2-2 is a sample.
  • Page 52 Safety Vscan Extend Labels (Example) (continued) Figure 2-3. Vscan Extend battery label Figure 2-4. Vscan Extend AC/DC adapter label Figure 2-5. Vscan Extend external battery charger label 2-26 – Vscan Extend User Manual 5721203-100 Rev. D...
  • Page 53 Type BF Applied Part symbol (see Vscan Extend system ‘Classifications’ on page i-5) Keep dry Vscan Extend system Input, use only Vscan Extend charger. Vscan Extend system Vscan Extend External Battery charger Rechargeable, use only Vscan Extend Vscan Extend system battery.
  • Page 54 Safety Table 2-8: Label Icons (Continued) Label Purpose Location Manufacturer name and address • Vscan Extend system • Vscan Extend External Battery charger Manufacturing date (year-month) • Vscan Extend system • Vscan Extend External Battery charger Part number • Vscan Extend system •...

  • Page 55: Explanation Of The Pollution Control Label For China

    • Applications of hazardous substances in this medical device are required to achieve its intended clinical uses, and/or to provide better protection to human beings and/or to environment, due to lack of reasonably (economically or technically) available substitutes. – 2-29 Vscan Extend User Manual 5721203-100 Rev. D...
  • Page 56 Safety 2-30 – Vscan Extend User Manual 5721203-100 Rev. D...
  • Page 57 Chapter 3 Preparing Vscan Extend for Contents: ‘Package contents’ on page 3-2 ‘System description’ on page 3-4 ‘Battery’ on page 3-15 ‘First time use’ on page 3-22 ‘Activation’ on page 3-24 – Vscan Extend User Manual 5721203-100 Rev. D...

  • Page 58: Chapter 3 - Preparing Vscan Extend For Use

    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 4. Region-specific plugs device and probe 5. AC/DC adapter 2.

  • Page 59: Environmental Requirements

    (see ‘Scan Settings’ on page 4-2) or change your position/location of use. The time required for the Vscan Extend to warm from minimum storage between uses until the device is ready for use at 20 degrees ambient is approximately 1 minute.

  • Page 60: System Description

    Preparing Vscan Extend for Use System description System overview Vscan Extend configured with a Sector probe for deep scanning Figure 3-2. Vscan Extend with a Sector probe 1. Display 4. Power button 2. Sector probe 5. LED indicates charging status 3.
  • Page 61 System description Vscan Extend configured with a Dual probe holding both a phased array and linear array transducer for deep and shallow scanning Figure 3-3. Vscan Extend with Dual probe 1. Display 4. Power button 2. Dual probe 5. LED indicates charging status 3.
  • Page 62 Preparing Vscan Extend for Use Vscan Extend Dual Probe Figure 3-4. The dual probe 1. Phased array transducer (deep scanning) 2. Linear array transducer (shallow scanning) – Vscan Extend User Manual 5721203-100 Rev. D...

  • Page 63: Accessories And Configurations

    The microSD card that captures error log files is used for troubleshooting by the Repair Depot. ** Not available in all countries – Vscan Extend User Manual 5721203-100 Rev. D...
  • Page 64 Preparing Vscan Extend for Use Table 3-3: Standard accessories Accessory Figure 8. Gel (60g bottle) * The microSD card provided in the device captures error logs and is strictly for Service personnel only. The user must remove this microSD card and insert a blank one when performing data backup.
  • Page 65 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.
  • Page 66 Wireless image export in DICOM format Access to reference materials on Vscan web portal * The Vscan Extend app represents only the interface to the cloud-based case exchange solution which is separately provided by GE A: Available Blank cells indicates: Not Available 3-10 –...

  • Page 67: 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.

  • Page 68: Display Screens

    Preparing Vscan Extend for Use Display screens Figure 3-6. Scanning screens (Black and white mode) Phased array transducer Linear array transducer 1. Header 1. Header • Menu icon • Menu icon • Patient information • Patient information • Exam number •...
  • Page 69 • Color icon • Gain • Gain • Depth • Depth • Store • Store 4. Color bar 4. Color bar 5. Color ROI (Region of Interest) 5. Color ROI (Region of Interest) – 3-13 Vscan Extend User Manual 5721203-100 Rev. D...
  • Page 70 Preparing Vscan Extend for Use Display screens (continued) Figure 3-8. Menu screen 3-14 – Vscan Extend User Manual 5721203-100 Rev. D...

  • Page 71: Vscan Extend Battery

    The battery must be charged while housed in the Vscan Extend or in the external battery charger. The Li ION battery, used in Vscan Extend, with the battery code is displayed below. Figure 3-9. Vscan Extend battery Battery specification...
  • Page 72 Battery (continued) Use only the AC adapter provided with the Vscan Extend. WARNING The Vscan Extend cannot be charged via the USB cable when connected to a PC. Figure 3-10. Vscan Extend AC adapter The AC adapter must be kept outside the patient environment CAUTION (refer to local regulation and EN 60601-1).
  • Page 73 Vscan Extend Battery Power plugs 1. Select the country specific plug. Figure 3-12. Power plugs 1. North America, Japan 4. UK, Hong Kong, Singapore 2. China 5. Continental Europe and Korea 3. Australia, New Zealand (for unearthed electrical outlet) 2. Insert the relevant plug into the adapter.
  • Page 74 Preparing Vscan Extend for Use Charging the battery 1. Insert the battery into the device. Figure 3-14. Insert the battery 2. Plug the AC/DC adapter into the electrical outlet. Charging the battery using the optional External battery charger compartment 1. Place the external battery charger on a flat surface.
  • Page 75 Vscan Extend Battery Battery level indicator The battery level indicator is displayed on the screen. The following icons are displayed. Table 3-8: Battery level indicator Icon Description Battery fully charged (>=95%). Battery 75% charged (>=70% and <95%). Battery 50% charged (>=45% and <70%).
  • Page 76 1. Insert the battery in the compartment until the lid clicks in place. Figure 3-15. Inserting battery To remove the battery 1. Power off the Vscan Extend. Do not attempt to remove the battery without powering off CAUTION the Vscan Extend.
  • Page 77 It is possible to charge the battery several times each day, if needed. When storing the Vscan Extend for a period longer than three months, remove the battery from the Vscan Extend main unit. Recharge the battery every three months to maintain battery performance.

  • Page 78: Initial Use

    Preparing Vscan Extend for Use Initial use First time use Before Vscan Extend can be used, the following steps must be done: 1. Install the battery. (See ‘To insert the battery’ on page 3-20 for more information.) 2. Press the Power button to power on Vscan Extend.
  • Page 79 Sleep Mode Vscan Extend enters sleep mode if it continues to be in standby mode for more than 3 hours. Push the Power button again to resume from sleep mode. The device is ready to scan within approximately 5 seconds.

  • Page 80: Vscan Extend Activation

    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 3.
  • Page 81 Initial use Set Language, Date and Time 1. Connect Vscan Extend to a power source. 2. Press the Power button to power on Vscan Extend. The Startup screen displays, followed by the Language screen. NOTE: The default language is set to English.
  • Page 82 Preparing Vscan Extend for Use Set Language, Date and Time (continued) 6. The Date and Time screen displays. NOTE: The current date and time is set by default. 7. Press Change Date and Time to change the date and time, if needed.
  • Page 83 (All non hidden Wi-Fi networks are displayed.) Figure 3-19. Wi-Fi settings 2. Press Next. NOTE: Ensure that the Vscan Extend is connected to a non-clinical Wi-Fi hotspot to start activation. NOTE: A non-clinical Wi-Fi has access to the public internet, which is not part of the hospital internet.
  • Page 84 Preparing Vscan Extend for Use Connecting Wi-Fi (continued) 1. Enter the authentication details to connect to the network. Figure 3-20. Authentication code 2. Once the device connects to the network, press the Back arrow to exit the Settings screen. The screen changes back to the Wi-Fi screen (Figure 3-19 on page 3-27.)
  • Page 85 Initial use Registration Registering the device creates a Vscan Extend account which enables access to the GE Marketplace and other features. First time registrants 1. First time registrants, press Register to create an account. Enter the required details. Figure 3-21. Registration details...
  • Page 86 The email has a link requiring you to change your password for security purposes. 4. Press Activate my device. Figure 3-23. Choose an option 5. Vscan Extend has been activated. Press Start Using Device. Figure 3-24. Start using Vscan Extend 3-30 –...
  • Page 87 Initial use Registered users NOTE: Ensure Vscan Extend is connected to a non-clinical Wi-Fi. 1. Press Already Registered. 2. Enter your email ID and password. Figure 3-25. Already Registered NOTE: If you log in with a wrong email ID, a pop-up message displays: “Login error: Your email ID is not confirmed yet”.
  • Page 88 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.
  • Page 89 Figure 3-27. Forgot password 3. Click on the link on a personal computer to reset the password. 4. Enter your email ID and new password. The Vscan Extend is activated and ready to use. Figure 3-28. Reset password and start using Vscan Extend –...
  • Page 90 GE at help@gehc.com to connect to the network. 3. If the network is not accessible or you are unable to connect to the network, you can activate Vscan Extend manually. See ‘Manual activation’ on page 3-35 for more information. 3-34 –...
  • Page 91 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.
  • Page 92 Preparing Vscan Extend for Use Manual activation (continued) 5. Press Submit to initiate registration. Figure 3-33. Submit 6. The Activation key is generated. Store the key in a convenient location to enter into the device and for future reference. Figure 3-34. Activation key details 3-36 –...
  • Page 93 Initial use Activation key The Activation key screen is displayed on the Vscan Extend. 1. Enter the activation key generated while registering on the portal (https://vscanactive.gehealthcare.com) Figure 3-35. Enter activation key Press the Backspace key if a mistake occurred while entering HINTS the activation key.
  • Page 94 Preparing Vscan Extend for Use 3-38 – Vscan Extend User Manual 5721203-100 Rev. D...

  • Page 95: Scan Settings

    ‘Scan Settings’ on page 4-2 ‘Server Settings’ on page 4-3 ‘Diagnostics’ on page 4-12 ‘Wi-Fi’ on page 4-21 ‘MDM Installation Procedures (Optional)’ on page 4-24 ‘Certificate Authority’ on page 4-28 ‘GE Marketplace’ on page 4-31 – Vscan Extend User Manual 5721203-100 Rev. D...
  • Page 96 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.

  • Page 97: Server Settings

    Figure 4-2. Server settings Worklist Server - gets patient and intended study information Image Server - remote store location for media (video/images) DICOM Encoding - Choose the desired encoding type and press – Vscan Extend User Manual 5721203-100 Rev. D...
  • Page 98 Vscan Extend Settings Server Settings (continued) To configure the Worklist server: Press the title bar (the entire top section on the screen) or HINTS swipe left most side of the screen to access the Menu. 1. Press Menu -> Settings Figure 4-3.
  • Page 99 Settings Configure Worklist Server Vscan Extend Connect to the hospital wireless network. See ‘Activation using Wi-Fi’ on page 3-24 for more information. 1. Enter all fields to add a new Worklist server. Figure 4-5. Configure Worklist Server NOTE: Swipe upwards to get the full screen and enter all details.
  • Page 100 Vscan Extend Settings Configure Worklist Server (continued) NOTE: By default, DICOM is listed while configuring the Worklist Server. Figure 4-6. DICOM listed 2. Enter any unique name for Calling AE Title (e.g. Nixon Building Schedule). 3. Press Add Server to add the Worklist Server.
  • Page 101 • Vscan Extend and the DICOM image server are not connected to the same network. Check network settings for all components. 5. Press and hold the selected Worklist entry to add to the favorites list.
  • Page 102 Vscan Extend Settings Configure Worklist Server (continued) 6. To add another Worklist server, press Add (+). Figure 4-9. Add another Worklist server 7. To delete the Worklist Server, press the Delete icon. Figure 4-10. Delete Worklist – Vscan Extend User Manual...
  • Page 103 Settings Configure Image Server 1. Press Menu -> Settings Figure 4-11. Menu 2. Scroll down to Server Settings. Press Image Server. Figure 4-12. Image Server – Vscan Extend User Manual 5721203-100 Rev. D...
  • Page 104 Vscan Extend Settings Configure Image Server (continued) 3. Enter your Image server’s IP address, port number, and Remote AE Title. Figure 4-13. Configure Image Server NOTE: Enter any unique name for Calling AE Title (e.g. Nixon Building Image Archive). Contact the hospital IT administrator for details.
  • Page 105 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. – 4-11 Vscan Extend User Manual 5721203-100 Rev.

  • Page 106: 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. 4-12 – Vscan Extend User Manual...

  • Page 107: System Settings

    Figure 4-17. System Settings • Admin Settings - Change date, time and configure Wi-Fi • GE Marketplace - Select an app • Facility Name - Set Facility Name • Session Duration - When the device is idle, data access is active for the duration set.
  • Page 108 Vscan Extend Settings System Settings (continued) • Configuration - Choose the desired option through an option key, either manually (enter the serial number of the device in the portal on a PC to obtain the option key) or (if Wi-Fi is connected, check for updates) Figure 4-18.

  • Page 109: Administrator Access

    2. Enter the new PIN again for confirmation. Figure 4-21. Confirm new PIN NOTE: The PIN is critical to accessing system data. Avoid sharing this PIN with non-administrators and take precautions to not lose this PIN. – 4-15 Vscan Extend User Manual 5721203-100 Rev. D...
  • Page 110 Vscan Extend Settings Administrator Access (continued) The new PIN provides access to advanced settings. Figure 4-22. Advanced Settings 4-16 – Vscan Extend User Manual 5721203-100 Rev. D...

  • Page 111: Storage Access

    1. Create a new PIN for data storage and access, for e.g., 1234. Figure 4-23. User PIN 2. Confirm the new PIN for security purpose. Confirmation is only required after PIN creation. Figure 4-24. Confirm PIN – 4-17 Vscan Extend User Manual 5721203-100 Rev. D...
  • Page 112 PIN to unauthorized users for data protection. Figure 4-25. Remember PIN The new PIN provides access to data storage and retrieval during normal use of the Vscan Extend. Incorrect PIN Vscan Extend prompts to enter the PIN after power ON or reboot.
  • Page 113 1. A pop-up message displays when an incorrect PIN is entered. Figure 4-26. Wrong PIN 2. After 5 wrong attempts, the Vscan Extend displays a pop-up message to “Backup” data on a microSD card before the next login. See ‘Backup’ on page 5-42 for more information.
  • Page 114 Vscan Extend Settings Incorrect PIN (continued) 3. If backup is not performed after 5 attempts of wrong PIN entry and once again a wrong PIN is entered, a pop-up message displays for every incorrect PIN entry thereafter. For e.g., 4, 3, 2, 1 attempt(s) left.

  • Page 115: Wi-Fi

    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.
  • Page 116 Vscan Extend Settings Activating Wi-Fi (continued) 3. Press Settings on the Dashboard. Figure 4-30. Advanced Settings 4-22 – Vscan Extend User Manual 5721203-100 Rev. D...

  • Page 117: Configuring Wi-Fi

    Procedure to check the MAC Address NOTE: If the Wi-Fi network has been configured with the MAC address, press MAC Address on the Advanced Settings screen. Figure 4-32. Mac address – 4-23 Vscan Extend User Manual 5721203-100 Rev. D...

  • Page 118: Mdm Installation Procedures (Optional)

    Vscan Extend Settings Deleting Wi-Fi networks 1. Press Settings from the Dashboard. 2. Press Wi-Fi. 3. Select the network to be deleted. A pop-up displays prompting you to forget or modify the network. 4. Press Forget network. MDM Installation Procedures (Optional)
  • Page 119 2. Install the correct MDM agent from Google Play (Airwatch, Mobile Iron). Figure 4-34. MDM 3. View the MDM service client with the help of your IT department. Figure 4-35. MDM installed – 4-25 Vscan Extend User Manual 5721203-100 Rev. D...
  • Page 120 Vscan Extend Settings MDM Installation Procedures (Optional) (continued) 4. Press the Back arrow to go to Dashboard. 5. Press Kiosk Settings. NOTE: Kiosk Settings provides access to advanced settings. Figure 4-36. Kiosk Settings 6. Press Admin Console App Chooser. Figure 4-37. Admin Console App Chooser 4-26 –...
  • Page 121 Settings MDM Installation Procedures (Optional) (continued) 7. Select the MDM Agent and press Update. Figure 4-38. Select MDM Agent Figure 4-39. Update The MDM agent is listed in the Dashboard. – 4-27 Vscan Extend User Manual 5721203-100 Rev. D...

  • Page 122: Certificate Authority

    1. Press the ... icon at the bottom of the Wi-Fi Screen. Certificate delivery is completed using an over-the-air enrollment method, where the certificate is delivered directly to your Vscan Extend via a browser link. NOTE: Contact your system administrator to download certificate on device.
  • Page 123 To complete the install, you need to add the certificate to your device's security credentials. • Press Security on the Settings screen. • Select Install from phone storage to get the certificate file from the downloads folder of your device. – 4-29 Vscan Extend User Manual 5721203-100 Rev. D...
  • Page 124 Wi-Fi depending on the certificate's purpose. Figure 4-42. Download Certificate The certificate is successfully downloaded onto your Vscan Extend. You can now choose it while connecting to a certificate based Wi-Fi authentication. 4-30 –...

  • Page 125: Ge Marketplace

    Settings GE Marketplace Registered users of Vscan Extend (with Wi-Fi Access or DICOM configuration) have access to GE Marketplace to install applications like Bladder Volume, Lung Protocol, Case Exchange and Tricefy on the Vscan Extend. NOTE: GE Marketplace registration is separate from device registration when activating the Vscan Extend.
  • Page 126 Vscan Extend Settings Installing Vscan Apps 1. Press GE Marketplace on the Settings screen. Figure 4-44. GE Marketplace Figure 4-45. Connecting to GE Marketplace 4-32 – Vscan Extend User Manual 5721203-100 Rev. D...
  • Page 127 Figure 4-46. List of Vscan Apps 3. Select the App (for example, Bladder Volume). Press Install. Figure 4-47. Install app 4. The App gets downloaded and prompts you to install. Press Install. – 4-33 Vscan Extend User Manual 5721203-100 Rev. D...
  • Page 128 While the apps are updating, there is no loss of data. The updated app requires no new permission. Uninstalling Apps 1. Press Menu -> Settings -> GE Marketplace. Press the App to uninstall. For example, Bladder volume. 2. Press Uninstall.
  • Page 129 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.
  • Page 130 Extend is yet to be confirmed. Type the registered email address and password. Press Login. Figure 4-51. Request for confirmation email A message displays: This Vscan Extend device has been registered to your account. The user account details page displays.
  • Page 131 Chapter 5 Using Vscan Extend Contents: ‘Scanning’ on page 5-2 ‘Measurements’ on page 5-24 ‘Review and recall of stored data’ on page 5-26 ‘Using Vscan Extend Apps’ on page 5-47 – Vscan Extend User Manual 5721203-100 Rev. D...

  • Page 132: Scanning

    Ensure that the main unit and the transducer are properly cleaned after each use and before storing in the case. If any damage is found on the transducer or its cable, DO NOT WARNING use the Vscan Extend. Contact GE service. – Vscan Extend User Manual...
  • Page 133 If the gel comes in contact with the eye, consult the gel CAUTION 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.
  • Page 134 Using Vscan Extend Other recommendations Like most high frequency computing devices, the electronic Vscan Extend components of will generate some heat while Vscan Extend operating normally and as intended. equipped with safety mechanisms which will automatically reduce computing speed (frame rate), and ultimately shut down Vscan the device, before any risk of overheating occurs.
  • Page 135 In the case of the dual probe, the LED light is also indicating which probe head is active. Figure 5-2. Dual probe: Orientation mark, phased array active 1. Orientation marking on probe 2. Green LED light 3. Orientation marking on screen – Vscan Extend User Manual 5721203-100 Rev. D...
  • Page 136 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 – Vscan Extend User Manual 5721203-100 Rev. D...
  • Page 137 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.
  • Page 138 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: •...
  • Page 139 5-37 for more information. 4. Retrieve the patient information from the DICOM modality worklist broker. Press Save. 5. Patient information also gets saved when the patient is associated with an exam with images. – Vscan Extend User Manual 5721203-100 Rev. D...
  • Page 140 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. Search icon 5-10 –...
  • Page 141 My Worklist. Perform the exam for this patient and press Save. Figure 5-8. Search patient NOTE: Patient information can be modified, if needed, using the Edit Patient feature. – 5-11 Vscan Extend User Manual 5721203-100 Rev. D...
  • Page 142 X (Harmonic for G3S phased and G8L linear array) array) To ensure optimal image quality, the Vscan Extend has predefined scanning settings optimized for different applications (e.g. Cardiac, Abdominal). Refer to the tables below to select the correct probe and preset combination before scanning.
  • Page 143 Ophthalmic * Ophthalmic is available as an option for certain countries but is NOT available in the USA, China and Japan. NOTE: Vscan Extend with Dual probe (shallow and deep) can be used for procedural guidance. – 5-13 Vscan Extend User Manual 5721203-100 Rev.
  • Page 144 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.
  • Page 145 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) – 5-15 Vscan Extend User Manual 5721203-100 Rev. D...
  • Page 146 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.

  • Page 147: Black And White Imaging

    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. – 5-17 Vscan Extend User Manual 5721203-100 Rev. D...
  • Page 148 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.
  • Page 149 The depth slider disappears after a few seconds. Press the Depth icon again to activate the control. • Press the Depth icon again to hide the depth control, if needed. Figure 5-16. Depth – 5-19 Vscan Extend User Manual 5721203-100 Rev. D...

  • Page 150: Color Imaging

    Using Vscan Extend Color imaging Color imaging is intended to add color coded qualitative information concerning the relative velocity and direction of fluid motion within the black and white image. 1. Press the Color icon. Figure 5-17. Color scan A color flow area displays on top of the black and white image.
  • Page 151 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. – 5-21 Vscan Extend User Manual 5721203-100 Rev. D...
  • Page 152 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.

  • Page 153: Auto Freeze

    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.

  • Page 154: Measurements

    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.
  • Page 155 4. Press Add New to make additional measurements on the displayed image. Up to 8 measurements can be made on a single image. Figure 5-21. Add new measurement Press Delete to delete a single measurement. – 5-25 Vscan Extend User Manual 5721203-100 Rev. D...

  • Page 156: Review And Recall Of Stored Data

    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.
  • Page 157 Reviewing and recalling images or videos from an exam list (continued) Figure 5-22. View stored images and videos NOTE: Press on the image in the Exams screen. Use the right/left arrow to naviagte through the images/videos. – 5-27 Vscan Extend User Manual 5721203-100 Rev. D...

  • Page 158: Deletion Of Data

    Using Vscan Extend Deletion of data To delete a file You can delete images or videos individually or from an exam list. Deleting individual images or videos 1. Press Menu. 2. Press Exams. 3. Select the Exam from which images or videos are to be deleted.
  • Page 159 1. Press Menu. 2. Press Exams. 3. Select the exam from the list. Figure 5-25. Images to be deleted 4. Press Delete to delete the images. 5. Press Cancel to cancel deletion. – 5-29 Vscan Extend User Manual 5721203-100 Rev. D...

  • Page 160: Data Export

    GE’s separate cloud-based case exchange solution is available in the U.S. and UK only. Audit Logs The Vscan Extend has audit logs of various types of events and activities. The audit logs captured in the microSD card can be exported to a PC.
  • Page 161 The files, file names, and folder names are non-patient identifiable. Import data The files exported to the PC can be copied back to a specific folder to the device with the USB cable (...\Import) – 5-31 Vscan Extend User Manual 5721203-100 Rev. D...
  • Page 162 Using Vscan Extend Windows Share Windows share allows the system to send ultrasound images to a PC. 1. Press Windows share from the list. Enter the required details - Domain name, IP address, User name and Password. Figure 5-26. Windows share 2.
  • Page 163 4. Select the created Windows Share destination. The exported folder is as as shown in the Figure 5-27 below. Figure 5-27. Exported image folder Figure 5-28. Images inside the exam folder – 5-33 Vscan Extend User Manual 5721203-100 Rev. D...
  • Page 164 Using Vscan Extend Share images (continued) 5. If the exported image does not get transferred to the PC or if the transfer fails, a red icon appears next to the image. Figure 5-29. Transfer failed 5-34 – Vscan Extend User Manual...
  • Page 165 To monitor/control DICOM and Windows share jobs, press Settings -> Device Status. The exam screen displays the job status, which range from: • in progress • success • failed • not started Figure 5-30. Device Status – 5-35 Vscan Extend User Manual 5721203-100 Rev. D...
  • Page 166 • manually • selecting from modality worklist 3. DICOM Store: Export DICOM images from Vscan Extend to the DICOM image server. DICOM modality worklist server To configure the DICOM modality worklist server, See ‘Configure Worklist Server’ on page 4-5 for more information.
  • Page 167 DICOM Modality Worklist: Retrieve patient information from DICOM Modality Worklist broker Vscan Extend can download and refresh a DICOM modality worklist. An exam can be linked to an existing patient pulled from the worklist, prior to exporting to the DICOM image server.
  • Page 168 Using Vscan Extend DICOM Modality Worklist: Retrieve patient information from DICOM Modality Worklist broker (continued) 2. Press Refresh to download Worklist entries. Figure 5-32. Refresh Worklist NOTE: It is not be possible to change the following DICOM attributes received from worklist: Patient Name, Patient ID and Accession Number.
  • Page 169 Review and recall of stored data Vscan Extend DICOM Store: exporting DICOM images from 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’...
  • Page 170 Using Vscan Extend DICOM Store: exporting DICOM images from Vscan Extend to DICOM image server (continued) 3. If more than one storage destination is configured, select the desired destination. Figure 5-35. Choose destination 4. Press Upload Selected to export the exam.
  • Page 171 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.

  • Page 172: Backup

    It is important to retain these error logs. It is also recommended WARNING to perform a backup of these logs for specified dates. GE is not responsible for loss data of these logs. Backup MUST be performed before sending the system to the repair depot as the data is wiped from the internal memory and cannot be retrieved.
  • Page 173 6. If the backup process is successful, the patient, exam, logs, and configuration data are backed up on the microSD card. The following message displays. Figure 5-40. Backup successful – 5-43 Vscan Extend User Manual 5721203-100 Rev. D...
  • Page 174 50% when initiating backup, the process fails. Retry backup. If still unsuccessful, insert a new microSD card and try again. 7. After backup is complete, power OFF the Vscan Extend. Remove the battery. Remove the backup microSD card and store in a safe place.

  • Page 175: Restore

    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. See ‘Inserting/removing the battery’ on page 3-20 for more information. Remove the microSD card containing the log files from the device and insert a blank microSD card.
  • Page 176 The system automatically shuts down. Figure 5-45. Power off 7. After restore is complete, power OFF the Vscan Extend. Remove the battery. Remove the backup microSD card and store in a safe place. The data is still retained on the microSD card.

  • Page 177: Using Vscan Extend Apps

    Using Vscan Extend Apps Using Vscan Extend Apps Overview There are four Apps avaiable on the Vscan Extend: • Bladder Volume • Lung Protocol • Tricefy Uplink Bladder Volume The Bladder Volume App calculates the bladder volume using 3 distance measurements from two orthogonal images (transverse and sagittal).
  • Page 178 Using Vscan Extend Installing the Bladder Volume application 1. Press Menu -> Settings -> GE Marketplace. Figure 5-46. GE Marketplace A list of available apps displays. 2. Press Bladder Volume App to view details. 3. Press Install. See ‘Installing Vscan Apps’ on page 4-32 for more information.
  • Page 179 Using Vscan Extend Apps Bladder Volume settings 1. Press App Settings from the Settings menu. A pop-up displays. Figure 5-47. Bladder Volume app settings 2. Press on the desired formula. Figure 5-48. Bladder volume formula • [0.7 x (D1 x D2 x D3)] •...
  • Page 180 Using Vscan Extend Using Bladder Volume To use the bladder app, the following are prerequisites: • Install the app using GE Marketplace. • Phased array probe is active. • Live image is frozen. The Bladder Volume App runs an algorithm on the currently...
  • Page 181 Using Vscan Extend Apps Using Bladder Volume (continued) 3. Press the Bladder icon to start the bladder measurement. The measurement cursors appear to perform the measurement. The widest points (D1 and D2) in a transverse image are perpendicular to each other.
  • Page 182 Using Vscan Extend Using Bladder Volume (continued) 4. Adjust the measurement calipers manually, if required. 5. Press Store. The screen enters sagittal capture. 6. Press to Freeze. Scroll to select the best frame. 7. Press Measure Frame. Figure 5-51. Measure Frame The image, along with the measurement values and volume, displays.
  • Page 183 Using Vscan Extend Apps Using Bladder Volume (continued) NOTE: The image is saved with the measurement values and volume embedded on it. View the saved images from the gallery. NOTE: The Bladder app cannot be used on stored images in the gallery.

  • Page 184: Lung Protocol

    3. Helps to calculate a total lung score 4. Generates a simple report at the end of the exam Installing the Lung Protocol application 1. Press Menu -> Settings -> GE Marketplace. A list of available apps displays. 2. Press Lung Protocol to view details.
  • Page 185 Using Vscan Extend Apps Lung Protocol settings (continued) The Settings screen displays. Figure 5-56. Settings The Settings menu has the following functions: • choose the number of segments to be scanned • choose the type of assessment • enter the Help mode.
  • Page 186 Using Vscan Extend Lung Protocol settings (continued) Types of Assessment Two types of assessment are available. Press on the radio button to choose the desired type of assessment. • Quantitative • Qualitative. Help mode Help mode is required to guide the user through the Lung Protocol.
  • Page 187 Using Vscan Extend Apps Lung Protocol settings (continued) 3. Press the Back arrow to return to the Protocols screen. Figure 5-57. Back arrow 4. Press Lung Protocol to start using the lung protocol. NOTE: The settings are automatically saved. If the settings need to be changed, stop the current protocol on the menu screen and modify the current settings on the Settings menu.
  • Page 188 Using Vscan Extend Using Lung Protocol (continued) 4. The lung linear preset is automatically applied. The lung preset is added as favorite in the Preset menu. Figure 5-59. Preset menu The scan screen displays. Figure 5-60. Lung protocol scan screen 1.
  • Page 189 Using Vscan Extend Apps Review and score images After all the images are stored for all the segments, a pop-up displays: Figure 5-61. Score images Press Score to score the images. Choose the score for each segment. Press Go Back to acquire more images.
  • Page 190 Using Vscan Extend Lung Protocol report After reviewing and scoring the last segment, swipe from right to left to enter the report screen. The report shows the current patient name, patient ID, and total lung score. Figure 5-63. Quantitative report Figure 5-64.
  • Page 191 Using Vscan Extend Apps Exit Lung Protocol 1. Press Menu on the Lung protocol screen. 2. Press Stop current protocol. A pop-up displays. Figure 5-65. Stop current protocol 3. Press Exit to stop the protocol. – 5-61 Vscan Extend User Manual...

  • Page 192: Tricefy

    Using Vscan Extend Tricefy Tricefy Uplink helps to upload exams to the cloud. 1. Press Menu -> Settings -> GE Marketplace 2. Press Install. The Tricefy Uplink app installs. Using Tricefy 1. Press Menu -> Settings -> Server Settings 2. Press Tricey under Image Server Figure 5-66.
  • Page 193 Using Vscan Extend Apps Using Tricefy (continued) 3. Enter your email address to register for Tricefy and press Activate. OR if you have a Tricefy login, enter that address and press Login. Figure 5-67. Tricefy Activate or login 4. Press Add Server and Verify.
  • Page 194 Using Vscan Extend Using Tricefy (continued) 5. Press Menu -> Export icon. Figure 5-69. Export 6. Press Upload Selected to export the exam. Figure 5-70. Upload selected exam The selected exam(s) are exported to the Tricefy server. 5-64 – Vscan Extend User Manual 5721203-100 Rev.
  • Page 195 Chapter 6 Vscan Extend Maintenance Contents ‘System care and maintenance’ on page 6-2 ‘Inspection’ on page 6-3 ‘Upgrade software’ on page 6-12 ‘Troubleshooting’ on page 6-14 – Vscan Extend User Manual 5721203-100 Rev. D...

  • Page 196: System Care And Maintenance

    The Vscan Extend requires regular care and maintenance to function safely and properly. The expected service life of the Vscan Extend is 5 years. To ensure that the Vscan Extend constantly operates at maximum efficiency, we recommend that the following procedures be observed as part of the customer’s internal...

  • Page 197: Inspection

    Inspecting the Vscan Extend If any defects or damages are found on the control unit, the CAUTION 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): •...

  • Page 198: Cleaning And Disinfection

    Ensure that the main unit and the transducer are properly cleaned after each use and before storage in the case. If any defects or damages are found on the probe or its cable, WARNING DO NOT use the Vscan Extend. Contact GE service. – Vscan Extend User Manual...
  • Page 199 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.

  • Page 200: Method Of Cleaning: Manual

    CAUTION methods that may damage the inside or surface of the device. DO NOT scratch or press any part of the Vscan Extend with a sharp object, such as pencils or pens, as this may result in damage to Vscan Extend.

  • Page 201: Disinfecting The Device

    In order to provide users with options in choosing a germicide, GE routinely reviews new medical germicides for compatibility with the Vscan Extend and its probe. Although a necessary step in protecting patients and employees from disease transmission, liquid chemical germicides must also be selected to minimize potential damage to the probe.
  • Page 202 Vscan Extend Maintenance Cleaning agents Follow the instructions described below while using CaviWipes and Sani-Cloth HB. CaviWipes 1. Use one CaviWipes towelette to completely preclean the surface of the device, probe and cable. 2. Ensure that no debris and bioburden are left behind.

  • Page 203: Disinfecting The Probe

    In order to provide users with options in choosing a germicide, GE routinely reviews new medical germicides for compatibility with the materials used in the transducer housing, cable and lens. Although a necessary step in protecting patients and...
  • Page 204 Vscan Extend Maintenance Disinfecting the probe (continued) Do not immerse the probe in any liquid beyond the level WARNING specified (see Figure 6-3). The probe should not be exposed to the germicide longer than specified in order to achieve the desired effect.

  • Page 205: Rinsing And Lubricating Agents

    In this case, the contaminated device/ probe MUST BE discarded in accordance with local biologic waste hazard procedures. Biological Hazard Rinsing and Lubricating Agents No rinsing and lubricating agents are required. – 6-11 Vscan Extend User Manual 5721203-100 Rev. D...

  • Page 206: Upgrade Software

    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.
  • Page 207 If you try to do so, a message displays: “Not allowed to proceed”. The Vscan Extend may have security patches which need an update. GE is not responsible for any virus affecting the Vscan Extend WARNING device which may result in data loss. –...

  • Page 208: Troubleshooting

    Troubleshooting Vscan Extend troubleshooting Table 6-2: Troubleshooting Problem Possible cause Solution Vscan Extend has no power. Battery not inserted. Insert battery (see page 3-20) Battery not charged. Charge the battery (see page 3-18) Battery defect or end of life. Contact GE Service (see page 1-10) Broken battery connection.
  • Page 209 This will also ensure a longer scanning time with maximum frame rate Vscan Extend is not entering the Battery may not have sufficient Charge the Vscan Extend battery scan screen and stays on the GE charge.

  • Page 210: 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.
  • Page 211 Unable to connect. WARNING Check Wi-Fi connection. • Acquisition level Check battery and recharge the system. WARNING If the problem persists, contact GE service. System messages • Perform system backup System internal memory usage is 50 to 60%. WARNING Perform system backup.
  • Page 212 Vscan Extend Maintenance 6-18 – Vscan Extend User Manual 5721203-100 Rev. D...
  • Page 213 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. D...

  • Page 214: Specifications

    2.9 cm with maximum depth of 8 cm • The color flow sector represents blood flow over image with full aperture and entire depth. • Broad-bandwidth linear probe: from 3.3 to 8.0 MHz • Footprint: 9 x 35 mm – Vscan Extend User Manual 5721203-100 Rev. D...

  • Page 215: Acoustic Output Reporting Tables

    Attenuated Temporal-Average Intensity / (at depth z) Spatial-Peak Temporal-Average Intensity Attenuated Spatial-Peak Temporal-Average Intensity Mechanical Index Output Power / Time average acoustic power at the source Attenuated Output Power / Time average acoustic power derated to depth z – Vscan Extend User Manual 5721203-100 Rev. D...
  • Page 216 Distance from the Source to a Specified Point / (same) Depth for TIB / Depth at which the relevant index is maximum Break-Point Depth / (same) Depth for TIS / Depth at which the relevant index is maximum – Vscan Extend User Manual 5721203-100 Rev. D...
  • Page 217 If neither an index or a footnote is given, this means that the index is irrelevant for this probe/mode combination. Operating Conditions All table entries are with the operating conditions specified at the end of the table. – Vscan Extend User Manual 5721203-100 Rev. D...

  • Page 218: Acoustic Output Reporting Tables For Track 3/En/Iec 60601-2-37

    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 – Vscan Extend User Manual 5721203-100 Rev. D...
  • Page 219 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. D...
  • Page 220 Appendix Dual Probe Linear array transducer Operating Mode: black/white Figure 7-3. Linear array transducer - black/white – Vscan Extend User Manual 5721203-100 Rev. D...
  • Page 221 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. D...
  • Page 222 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. D...
  • Page 223 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 – 7-11 Vscan Extend User Manual 5721203-100 Rev. D...
  • Page 224 Measurement accuracy Measurement Unit Useful range Accuracy Probe Distance Axial Full screen ±3% or ±1 mm, Both probes whichever is greater Lateral Full screen ±5% or ±1 mm, Shallow whichever is greater 7-12 – Vscan Extend User Manual 5721203-100 Rev. D...
  • Page 225 The average value 1540 meters / second is used for all calculations. Depending on the tissue structures, this generalization may give errors from 2% (typical) to 5% (much fatty tissue layers present). – 7-13 Vscan Extend User Manual 5721203-100 Rev. D...
  • Page 226 Appendix 7-14 – Vscan Extend User Manual 5721203-100 Rev. D...
  • Page 227 ‘Privacy and Security Environment’ on page 8-3 ‘Privacy and Security Capabilities’ on page 8-3 ‘Network Connectivity’ on page 8-6 ‘Information Protection’ on page 8-9 ‘Personal Information Collected by the Product’ on page 8-17 – Vscan Extend User Manual 5721203-100 Rev. D...

  • Page 228: Overview

    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.
  • Page 229 When no longer used, the data should be securely erased and/or the media should be securely deleted. 5. The display of the Vscan Extend should be placed in a way limiting the visibility to the user only. Privacy and Security Capabilities The GE Healthcare Vscan Extend incorporates a broad assortment of capabilities to enable Privacy and Security.
  • Page 230 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.
  • Page 231 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.

  • Page 232: Network Connectivity

    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.
  • Page 233 Windows machine is supported over a hospital clinical wireless network and a hospital public wireless service that are used for GE cloud connectivity to push the data using SSL/TLS. The table below describes interconnections in more detail: Table 8-1:...

  • Page 234: Network Requirements

    2. Both DHCP and static IP allocation are supported Network Protocols Wireless network protocols The following wireless protocols are supported: 1. IEEE 802.11b 2. IEEE 802.11g 3. IEEE 802.11n Internet Protocol Version: 1. IPv4 2. IPv6 – Vscan Extend User Manual 5721203-100 Rev. D...

  • Page 235: Information Protection

    Vscan Extend Ultrasound system. The Vscan Extend is supported with an internal firewall. The following two sections describe the configuration of the firewall and the guidance for configuring the IT infrastructure where it is connected.
  • Page 236 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.
  • Page 237 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.
  • Page 238 UI on the Vscan Extend Ultrasound system. NOTE: There is no network file share on the Vscan Extend Ultrasound system. Network infrastructure The infrastructure of the network where the Vscan Extend is...
  • Page 239 The patient information will not be displayed. Removable media on the Vscan Extend Ultrasound system The Vscan Extend supports USB cable connection to export images and videos to a PC. The removable microSD cards are used for the following: 1.
  • Page 240 Privacy and Security Data destruction for portable media The Vscan Extend does not have the internal functionality to securely delete data stored on the removable devices. Approved procedures and tools should be used to securely remove data stored on removable media, according to...
  • Page 241 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. If there are data network related problems, which prevents the Vscan Extend from connecting to an external patient archive, the device can be fully functional by storing patient data/images to the Local Archive.

  • Page 242: System Protection

    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.

  • Page 243: Personal Information Collected By The Product

    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.

  • Page 244: 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 operaitons, the system might support collection of more data than is needed for a particular installation.

  • Page 245: Information Disclosure

    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.
  • Page 246 Information to individuals of collection, use and disclosure of PI/PHI Some users of the Vscan Extend may have certain requirements and policies to inform individuals (patients) about the collection, use and disclosure of PI/PHI. There is no support for such functionality in the system.

  • Page 247: Potential Hazardous Situations Resulting From Failures Of The It Network

    Warning In addition to the hazardous situations identified above, connection of the Vscan Extend to a network that includes other equipment could result in other unidentified risks to patients, operators or third parties. The responsible organization should identify, analyze, evaluate and control these risks on an ongoing basis.
  • Page 248 Privacy and Security 8-22 – Vscan Extend User Manual 5721203-100 Rev. D...
  • Page 249 Settings, 4-2 External battery charging compartment (option), 3-11 System description, 3-4 Indication for use, 1-4, 1-5 Tricefy, 5-62 Information Troubleshooting, 6-14 Requesting, 1-10 Inspection, 6-3 Upgrade application software, 6-12 USB export – Vscan Extend User Manual Index 5721203-100 Rev. D...
  • Page 250 USB export, 5-31 Using Vscan Extend, 5-1 Voltage requirements, 3-17 Vscan Extend Battery, 3-15 Vscan Extend Maintenance, 6-1 Vscan Extend Settings, 4-1 – Index Vscan Extend User Manual 5721203-100 Rev. D...

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