Technical Publications Vscan Version 1 User Manual GM092207 — English Rev. 02 Operating Documentation Copyright © 2014 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. It applies to all sub-versions of the software version 1 for the Vscan ultrasound system unless otherwise specified. This manual is a reference for the Vscan gateway software. It applies to all sub-versions of the software version 1 for the Vscan gateway software unless otherwise specified.
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 Vingmed Ultrasound. Ignoring this advice may compromise the regulatory approvals obtained for the product.
Country Specific Approvals • JAPAN MHLW Approved Number: 221ABBZX00252000 • CHINA SFDA: SFDA (I) 20113231266 Product Standard Number: YZB/NOR 0732-2011 • KOREA KFDA: 10-1194 Certifications • GE Vingmed Ultrasound is ISO 9001 and ISO 13485 certified. Classifications The following classifications are in accordance with the IEC/ EN 60601-1. Type and degree of protection against electric shock: • Vscan is internally powered battery operated during hand held scanning. • The AC adapter is Class II.
Type BF Applied part TYPE BF APPLIED PART providing a specified degree of protection against electric shock, with particular regard to allowable LEAKAGE CURRENT. Normal mode Patient leakage current <100 microA Single fault condition <500 microA Environmental requirements for the unit Requirement Temperature Humidity non-condensing Air Pressure Operational 10–40 °C 30–80% 700–1060 hPa Non operational -20–70 °C 30–90% 700–1060 hPa NOTE: Avoid exposing the unit to saline moisture.
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Table of Contents Conformance Standards - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-1 Country Specific Approvals - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-2 Certifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-2 Classifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-2 Class II Equipment - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Vscan activation Activation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-22 Configuration - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-22 Chapter 3 — Using Vscan Switching on/off To switch on the Vscan - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-2 To switch off the Vscan - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-2 Scanning General scanning recommendations- - - - - -
Cleaning and disinfection Cleaning - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-4 Disinfection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-5 Reinstallation of the factory software Procedure - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-7 Troubleshooting Vscan troubleshooting- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-9 Vscan gateway software t
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Chapter 1 Introduction Contents: ‘General description’ on page 1-2 ‘Warnings’ on page 1-4 ‘Conventions used in this manual’ on page 1-6 ‘Contact Information’ on page 1-7 Vscan – User Manual GM092207 02 1-1
Introduction General description Vscan is a battery operated pocket-sized general purpose ultrasound imaging system. Principles of operation Medical ultrasound images are created by computer and digital memory from the transmission and reception of mechanical high-frequency waves applied through a probe. The mechanical ultrasound waves spread through the body, producing an echo where density changes occur. The echoes return to the probe where they are converted back into electrical signals.
General description Indication for use The Vscan ultrasound unit is intended for the following applications: • Cardiac adult and pediatric • Abdominal • Pediatric • Urology • Fetal • Peripheral vascular • Thoracic/Pleural motion and fluid detection Contraindication The Vscan ultrasound unit is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye.
Introduction Warnings To prevent damage of the equipment or injury to yourself or others, read the following safety warnings before using the Vscan. WARNING 1-4 • Vscan is a precision instrument. Handle Vscan and its accessories with care. Do not subject Vscan to mechanical shock or impact. • Do not attempt to disassemble or alter any part of the unit including the probe, the battery, the AC/DC adapter and accessories. Disassembly or modification may result in electrical shock.
Warnings WARNING Vscan – User Manual GM092207 02 • Do not short-circuit the battery terminal with metallic objects. This may result in overheating and burns. • Do not store or carry a battery loosely with metallic devices. • Disconnect the battery charger when not in use to avoid fire hazard. • Keep the charger dry. Failure to observe this precaution may result in fire and electric shock • Keep this unit out of reach of children.
Introduction Conventions used in this manual Buttons and other controls on the Control panel or on the monitor screen are indicated by bold type. Program windows, screens and Dialogue boxes are indicated by italic type. The following icons, highlight safety issues as follow: 1-6 DANGER Indicates that a specific hazard exists that, given inappropriate conditions or actions, will cause severe or fatal personal injury with or without substantial property damage.
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 GE Healthcare TEL: (1) 800-437-1171 Ultrasound Service Engineering FAX: (1) 414-721-3865 9900 Innovation Drive Wauwatosa, WI 53226 Clinical Questions Please contact your local Applications or Sales Representative.
Introduction TEL: (1) 800-472-3666 In other locations, contact your local Applications, Sales or Service Representative. Global ultrasound support center phone numbers For countries not listed in the tables below, please contact the local distributor. When contacting Support you will have to provide your system ID. If system ID is unknown, please give the Temporary System ID “VSCAN” to be properly routed for support.
Contact Information Europe, Middle East and Africa Region Telephone Location Algeria +21321484612 Andorra 902 400 246 Austria 0800244260 Vienna Belgium Dutch +32 262 638 38 Diegem Belgium French +32 262 638 39 Diegem Bulgarian +35929712040 Sofia Denmark 80404944 Stockholm Egypt +202 19434 [hot line] Cairo Finland 0981710182 Stockholm France 0800139140 Velizy G. D.
Introduction Region Telephone Location South Africa 800 111 671 South Africa Spain 902 400 246 Madrid Sweden 0201201436 Stockholm Switzerland 0800556958 Zurich Turkey Contact local distributor Istanbul UAE 800 3646 Saudi Arabia UK 0845 8503392 Bedford Ukraine +38 044 391 37 56 (57) 1-10 Vscan – User Manual GM092207 02
Contact Information Asia and Pacific Region Telephone Location China 8008108188 Beijing Hong Kong (852) 21006288 Hong Kong Taiwan 0800-021-770 Taipei India (91) 1800-425-8025 Bangalore Singapore (65) 62773444 Singapore Australia 1-800-659-465 Brisbane New Zealand 0800 65 94 65 Brisbane Japan 0120-055-919 Tokyo Korea (82) 2-1544-6119 Seoul Bangladesh (880) 29135488 Dhaka Sri Lanka (94) 114891178 Colombo Bhutan Contact GE India Maldives Contact GE India Nepal Contact l
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Chapter 2 Preparing the Vscan for use Contents: ‘Package contents’ on page 2-2 ‘System description’ on page 2-5 ‘Battery’ on page 2-11 ‘The microSD card’ on page 2-17 ‘First time use’ on page 2-21 ‘Vscan activation’ on page 2-22 Vscan – User Manual GM092207 02 2-1
Preparing the Vscan for use Package contents Make sure all items listed below are included in the package. 1. Vscan unit Storage microSD card installed in Vscan 2. Soft bag 3. USB 2.0 cable 4. Battery (GM-BAT) 5. Coupling gel 6.
Package contents Quick card CD-ROM Vscan gateway software CD-ROM user manual Service contact information microSD card with factory SW (In a sealed envelope – only to be used in agreement with service organization) Vscan – User Manual GM092207 02 2-3
Preparing the Vscan for use 1. Docking station 2. AC/DC converter 3.
System description System description System overview The Vscan device 1. 2. 3. 4. 5. Microphone 6. Docking station connector 7. Battery (GM-BAT) and microSD card compartment lid Probe G3S Control panel Display Loud speaker Figure 2-1.
Preparing the Vscan for use The display Black and white scanning screen (default) 1. Scanning information • Examination number (page 3-5) • Current date • Current time • Scanning preset (page 3-6) • Mechanical and Thermal Index (page 7-16) 2. Depth scale (page 3-7) 3. Orientation marker (page 3-5) 4. Header • Battery level indicator (page 2-14) • Memory indicator of the microSD card (page 2-19) Figure 2-2. 2-6 Menu screen (displayed when pressing Menu.) 1.
System description The Control panel Key Usage Select key • Freeze/unfreeze in live mode. • In a menu or a dialog: select highlighted item. • Press and hold to return to black and white imaging. • Navigate in menus. • Navigate through examinations in the Gallery screen. • Move color area and caliper. • Navigate in menus. • Pause/play movie. • Navigate through examinations in the Gallery screen. • Move color area and caliper. • Decrease Depth. • Navigate through files in Gallery screen.
Preparing the Vscan for use Key Usage Store key • Store current acquisition (movie or single frame). • Press and hold to start voice notation. Press any key to end voice notation. Menu key • Enter the system menu. • Move one level up in system menu. • Exit the system menu.
System description The Docking station The Docking station is used to: NOTE: • Connect the Vscan to a computer. • Charge the Vscan battery. • Store the Vscan when not in use. The Docking station is designed for in-house use only. Do not use the Docking station in ambulance or other vehicles. 4. Charger (GM-CHA) connector 5. USB port to computer 1. Vscan cradle 2. Probe holder 3. Vscan connector Figure 2-3.
Preparing the Vscan for use The External battery charging compartment (option) The external battery charging compartment is used to charge spare battery outside the Vscan. 1. Charger (GM-CHA) connector Figure 2-4.
Battery Battery The Vscan is powered by a Lithium Polymer battery (GM-BAT). The battery is not fully charged at shipment. To maximize time of use, it is recommended to recharge the battery before use for at least 1.5 hour. Make sure to establish a routine for charging the battery to maximize system availability. It is recommended to charge the battery (GM-BAT) in the Vscan placed on the Docking station, or by using the external battery charging compartment as described below.
Preparing the Vscan for use CAUTION Do NOT touch simultaneously the patient and the charger plug on either the AC/DC adapter, the Docking station or the external battery charger. Power plug adapter 1. Select the country specific plug. 1. 2. 3. 4. 5. 6. North America, Japan China Australia New Zealand UK, Hong Kong, Singapore Continental Europe and Korea (for unearthed electrical outlet) Continental Europe and Korea (for earthed electrical outlet) 2. Place the plug onto the AC/DC adapter. 3.
Battery 2. Plug the charger (GM-CHA) plug into the charger connector on the Docking station. 3. Plug the AC/DC adapter into the electrical outlet. CAUTION Only use mains power of 100 – 240 VAC. Voltage outside this range can cause malfunction or destroy the AC/DC adapter. The charge lamp on the charger (GM-CHA) is lit in amber when charging the battery and turns green when the battery is fully charged. Charging the battery using the External battery charging compartment 1.
Preparing the Vscan for use Battery level indicator The battery level indicator is displayed on the header. The following icons are displayed. Icon Description Battery fully charged. Battery partially discharged. Low Battery, prepare to recharge the battery or have a spare battery available. Discharged battery, recharge the battery or replace with a spare battery. Battery charging.
Battery Removing / inserting the battery (GM-BAT) To remove the battery 1. Close the display. CAUTION Do not attempt to remove the battery without closing the display. 2. Push the button on the battery compartment lid and pull the battery (GM-BAT) out. To insert the battery 1. Insert the battery (GM-BAT) in the compartment until the lid clicks in place.
Preparing the Vscan for use Battery (GM-BAT) specifications Item Specification Charging time About 1.5 hour Capacity About 1 hour and 15 min active use* Lifetime At least 300 charges * Assuming mixed black and white (80%) and color imaging usage and a new battery. Batteries generally degrade by aging and number of recharging cycles, and will have reduced capacity over time.
The microSD card The microSD card Image acquisitions and voice notation recordings are stored to a microSD card (MicroSD or MicroSDHC, speed grade 6 or lower). The microSD card is located under the battery. Removing / inserting the microSD card To remove the microSD card 1. Remove the battery (GM-BAT) (see page 2-15). 2. Slide and raise the card slot. 3. Remove the microSD card from the card slot.
Preparing the Vscan for use 4. Lower and slide the slot card back in place. To insert the microSD card 1. Remove the battery (GM-BAT) (see page 2-15). 2. Slide and raise the card slot. 3. Insert the microSD card in the card slot.
The microSD card Make sure the card is inserted in the card slot. 4. Lower and slide the slot card back in place. 5. Insert the battery (GM-BAT) in the compartment (see page 2-15). The microSD card memory indicator The microSD card memory indicator is displayed on the header. The following icons are displayed. Icon Description The card is empty The card is partially filled up The card is nearly full The card is full No card in the Vscan device, or card disabled from device while mounted to computer.
Preparing the Vscan for use The microSD card handling recommendations The microSD cards are sensitive electronic devices. • 2-20 Do not bend the microSD cards or subject them to shocks or vibrations.
First time use First time use Before the Vscan can be used the following steps must be done: • Install and charge the battery. • Activate the Vscan (page 2-22). Installing the battery 1. Insert the battery (GM-BAT) in the compartment until the lid clicks in place. 2. Make sure the battery is fully charged (see page 2-11) before activating the Vscan.
Preparing the Vscan for use Vscan activation Activation There are three possible scenarios to activate the Vscan: 1. Scenario 1 (preferred): online activation of Vscan and/or Vscan gateway: • Install Vscan gateway software (see ‘Installation of the Vscan gateway software’ on page 4-5) • Activate your Vscan and Vscan gateway software from the Vscan web portal on the Internet (see ‘Online activation’ on page 4-7). 2.
Vscan activation 2. Press Select when done. 3. Press to continue the configuration. The Time screen is displayed. Adjust time 1. Use / seconds. Use / 2. Press to navigate between hours, minutes and (or Rotate) and press Select to set each item. to continue the configuration. The Date screen is displayed. Adjust date Vscan – User Manual GM092207 02 1. Use / to navigate between days, months and years. Use / (or Rotate) and press Select to set each item.
Preparing the Vscan for use 2. Press to continue. • If the activation key was obtained online the Vscan is then ready for use. • If the activation key was obtained offline the Activation screen is displayed. Activation key (Scenario 3 only) This step is only required if doing offline activation of the Vscan. 1. Use / / / to highlight the digit or character to enter and press Select. The next entry in the activation key is highlighted. 2.
Vscan activation The Vscan is ready for use.
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Chapter 3 Using Vscan Contents: ‘Scanning’ on page 3-3 ‘Measurements’ on page 3-9 ‘Voice notations’ on page 3-10 ‘Review and storage’ on page 3-11 ‘Recall of stored data’ on page 3-13 ‘Deletion of data’ on page 3-14 Vscan – User Manual GM092207 02 3-1
Using Vscan Switching on/off To switch on the Vscan 1. Open the display. After initialization the black and white scanning screen is displayed. To switch off the Vscan There are two ways to switch off the Vscan: • Close the display Or • NOTE: Use the Shutdown menu The system will delete any acquisition that is not stored when closing the display. To save the current acquisition, press Store before closing the display. Switch off using the Shutdown menu 1. Press Menu. 2.
Scanning Scanning General scanning recommendations Before each use: • Inspect the probe (see ‘Inspecting the probe’ on page 6-3). • Inspect the probe (see ‘Inspecting the probe’ on page 6-3) • Clean the probe (see ‘Disinfection’ on page 6-5). • If required disinfect the probe (see ‘Disinfection’ on page 6-5). After each use: CAUTION If any damage is found on the probe or its cable, DO NOT use the Vscan. Contact GE service.
Using Vscan Coupling gels should not contain the following ingredients as they are known to cause probe damage: • Methanol, ethanol, isopropanol, or any other alcohol-based product • Mineral oil • Iodine • Lotions • Lanoline • Aloe Vera • Olive Oil • Methyl or Ethyl Parabens (para hydroxybenzoic acid) • Dimethylsilicone The following gels have been tested to be compatible with the Vscan. Aquasonics 100 Parker Laboratory Inc. Clear Image Sonotech Inc. Scan Parker Laboratory Inc.
Scanning CAUTION Do not scan on open wound. Probe orientation The probe is provided with an orientation marking. 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. 1. Orientation marking on probe 2. Orientation marking on screen Patient examination When scanning several patients make sure to create a new examination between each patient. To create a new examination: 1. Press Menu. 2.
Using Vscan NOTE: A new examination is also created automatically when the system is restarted. Presets To ensure optimal image quality the Vscan has predefined scanning settings optimized for different applications (e.g Cardiac, Abdominal). Make sure to select the correct preset before scanning. The current preset is displayed on the screen. To change preset: 1. Press Menu. 2. Use / to browse through the menu items and highlight Presets . 3. Press Select. The Preset menu is displayed. 4.
Scanning 2. The following adjustments can be done to further improve the image quality: • Auto optimize: press and hold down Select. A green dot is displayed on the left of the image sector indicating that the image settings have been optimized based on the current acquisition. To turn off Auto optimize, press and hold down Select. NOTE: If you change the probe position or adjust the Depth you may need to optimize again. • Depth / Depth adjusts the field of view.
Using Vscan Color aliasing If the blood flow velocity exceeds the maximum velocity range the system can cover, based on the sampling rate used, aliasing will occur. Aliasing will appear 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. Auto freeze If Vscan is idle for more than the Auto freeze time set in Config it enters in freeze mode to minimize overheating.
Measurements Measurements Taking measurements The Vscan enables distance measurement on frozen images in both black and white and color imaging. Up to three measurements can be performed on an image. Measurements can be done during image review before storage or on recalled stored images. To perform a measurement: 1. On a frozen image, press Menu. 2. In the main menu, use / items and highlight Distance to browse through the menu . 3. Press Select. A red caliper is displayed. 4.
Using Vscan Voice notations Recording Voice notations Voice notations can be recorded at any time. The voice notations are stored in the current examination folder. To make a voice notation: 1. Press and hold down Store to start recording. 2. Record your message. A red blinking recording symbol and a timer are displayed while recording. NOTE: The maximum voice recording time is 10 minutes. 3. Press any button to end recording. The voice notation is saved to the current examination folder.
Review and storage Review and storage During live scanning, acquired images are temporarily stored on the system’s memory (image buffer). When the system’s memory is full, new images are replacing the oldest acquisitions. To keep images the acquisition has to be stored to the microSD card. Reviewing acquired images 1. While scanning, press Select to freeze the image. 2. While in freeze, Rotate to scroll through the acquired images one by one. 3. Press NOTE: to display the acquisition as a movie.
Using Vscan Movie storage 1. While scanning or during movie replay, press Store . The movie is stored to the microSD card. A confirmation message is briefly displayed on screen.
Recall of stored data Recall of stored data Images and voice notations stored on the microSD card can be recalled for review. To recall stored data: 1. Press Menu. 2. In the main menu, use / items and highlight Gallery to browse through the menu . 3. Press Select. The Gallery screen is displayed. 4. In the Gallery screen, use examination folder. / to browse to the desired 5. In the selected examination folder, use the file to open.
Using Vscan Deletion of data To delete an examination 1. Press Menu. 2. In the main menu, use / items and highlight Gallery to browse through the menu . 3. Press Select. The Gallery screen is displayed. 4. In the Gallery screen, use examination to delete. / to browse to the 5. Press Menu. 6. Use / until Delete exam is highlighted. 7. Press Select. A confirmation dialog is displayed. 8. Press Select (OK) to delete the examination. NOTE: The newest active examination cannot be deleted.
Chapter 4 Vscan gateway software Contents: ‘Overview’ on page 4-2 ‘Vscan gateway software installation’ on page 4-4 ‘Connection of Vscan to a computer’ on page 4-18 ‘Using Vscan gateway software’ on page 4-20 Vscan – User Manual GM092207 02 4-1
Vscan gateway software Overview Data acquired on Vscan can be viewed on a personal computer after installing the Vscan gateway software, a dedicated viewer for GE handheld ultrasound scanners. Vscan gateway software can read data either directly from a connected Vscan (on a Docking station) or by inserting the Vscan microSD card into a card reader (not provided) connected to the computer.
Overview CAUTION Vscan – User Manual GM092207 02 Do not change the file or folder name. Vscan and Vscan gateway software will not be able to open a file if the file name and containing folder name do not match. This is to minimize the risk of data mix if files are moved inadvertently between examination folders or renamed in the computer.
Vscan gateway software Vscan gateway software installation Computer requirements The minimum requirements for the computer are listed in the table below Item Minimum requirements OS Windows XP Professional SP2 or later Windows Vista From Vscan gateway v. 1.1.1: Windows 7 32-bit and 64-bit versions are supported. Windows 7 running in VMware Virtualization Software on Mac OS X 10.6 is supported. CPU Pentium 4 (2.4 GHz) or Pentium M (1.
Vscan gateway software installation NOTE: CAUTION Password protection should be used on the computer running Vscan gateway software, since the software is handling patient information (e.g. patient name, ID and birthdate). GE has verified and validated the stability and safe operation of Vscan gateway software on a variety of personal computers complying with the minimum requirements listed above.
Vscan gateway software If the CD does not start automatically, press Start, select Run and enter X:\setup.exe (where X is the CD drive letter) in the Run window. 2. Press Next. The Destination window is displayed. 3. Press Next to install Vscan gateway software to the default folder or press Browse to install Vscan gateway software to another location. The files are being copied and the User manual installation procedure window is displayed.
Vscan gateway software installation The computer needs to be restarted before Vscan gateway software can be used. 5. Press Finish to end the installation and restart the computer. Activation of Vscan and Vscan gateway software There are two ways to activate the Vscan and Vscan gateway software: NOTE: • Online activation: create your Vscan Activation key and Vscan gateway software System ID from the Vscan web portal on the Internet as described in ‘Online activation’ on page 4-7.
Vscan gateway software 2. Select the desired language for the program and for the user manual and press OK. The Vscan gateway software activation window is displayed. 3. Dock your Vscan on the Docking station and open the display to start Vscan.
Vscan gateway software installation After approximately 30 seconds the required Serial Number of the Vscan should be automatically filled in the Activation window. NOTE: If you are not able to dock the Vscan, enter the Serial Number manually in the Activation window. The Serial number can be found on the label on the rear of the unit. 4. Press Retrieve Activation key(s). The Internet browser application is started and displays the Vscan Product Activation form (not shown). 5.
Vscan gateway software The System ID and Activation key fields are displayed and automatically filled in. NOTE: If the System ID and Activation key field do not get automatically filled in, return to the Activation Success page and re-copy the System ID and activation key. Then go back to the Activation window above and press Paste or Ctrl + v. 8. Press Next. The Vscan unit is now ready for first time configuration (see ‘Configuration’ on page 2-22). Write down the Vscan Serial Number. 9. Press OK.
Vscan gateway software installation 10. Press Configure. The Insite Configuration tool window is displayed.
Vscan gateway software All entries in bold in the Insite configuration window must be filled in. • Continent • Country • City • Institution • Proxy: Disable unless a proxy server is provided by your institution (contact the IT administrator). Fill in the necessary information and press Submit changes. Once the configuration is saved close the Insite configuration tool window. 11. Press Next and step through the next pages to check the basic software controls (e.
Vscan gateway software installation 2. Select the desired language for the program and for the user manual and press OK. The Vscan gateway software activation window is displayed. 3. Dock your Vscan on the Docking station and open the display to start Vscan.
Vscan gateway software After approximately 30 seconds the Serial Number of the Vscan should be automatically filled in the Activation window. NOTE: If you are not able to dock the Vscan, enter the Serial Number manually in the Activation window. The Serial number can be found on the label on the rear of the unit. 4. Press Contact service in the Vscan gateway software activation window. Write down the telephone number and contact GE Service to get your Vscan key and Vscan gateway software System ID.
Vscan gateway software installation 6. Fill in manually the System ID and/or Activation key provided by GE Service. 7. Press Next. The Vscan unit is now ready for first time configuration (see ‘Configuration’ on page 2-22). Write down the Vscan Serial Number. 8. Press OK. The Insite configuration window is displayed. 9. Press Configure.
Vscan gateway software The Insite Configuration tool window is displayed. With no Internet access there is no need to configure Insite. 10. Close the Insite configuration tool window and press Next. Step through the next pages to check the basic software controls (e.g audio replay, image adjustment controls and movie controls). NOTE: Refer to ‘Vscan gateway software troubleshooting’ on page 6-10 if you experience any issues during the functionality check.
Vscan gateway software installation The following will be required: • The Vscan Serial Number written on the rear label of the control unit. • Some user information. After obtaining the Activation key from GE Service the Vscan needs to be configured (see ‘Configuration’ on page 2-22). Going to the Internet 1. Go to http://vscan.gehealthcare.com. 2. Select Owners from the top navigation menu. 3.
Vscan gateway software Connection of Vscan to a computer CAUTION Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC standards (e.g. IEC60950 for data processing equipment and IEC60601-1 for medical equipment). Furthermore all complete configurations shall comply with the valid version of the system standard IEC60601-1-1.
Connection of Vscan to a computer The connected Vscan is automatically detected and mounted in Vscan gateway software. NOTE: Vscan – User Manual GM092207 02 To disconnect Vscan safely press the Disconnect device button in the Vscan gateway software Gallery screen or use the safe removal procedure from Windows.
Vscan gateway software Using Vscan gateway software Overview The Vscan gateway software is organized in screens as follows: 1. Gallery screen (default screen), see page 4-21. 2. Setup screen 3. On line documentation screen: displays online documentation and access to the Vscan web portal.
Using Vscan gateway software Gallery screen 1. List of devices connected to the computer and local storages. Select the device to display the examinations. 2. List of examinations on the selected device. Select an examination to display the files. 3. List of files (image or voice notation) for the current examination. Select the file to display/listen to. 4. Display of the selected image file. 5. Controls for the selected file: see ‘File specific controls’ on page 4-22. 6.
Vscan gateway software File specific controls The following controls are available when selecting a file in the Gallery screen (Figure 4-2). Still frame controls Control Description Contrast Control the amount of contrast. Brightness Control the amount of brightness. Movie controls Control / Play/Pause Description Start/stop the movie. Scroll slider Scroll through the movie by dragging the slider. / Backward/Forward Scroll frame by frame through the movie.
Using Vscan gateway software Patient information Patient information can be added to an examination. 1. Right-click on the examination and select Assign patient information in the context menu. The Assign patient information screen is displayed. 2. Enter the information and press OK. The information entered is displayed in the examination list and is used in the report.
Vscan gateway software Area measurement 1. Select Area in the Review pane. 2. Left-click to place the first point. Move the mouse to outline the area and left-click to place the end point. Annotation 1. Select Annot in the Review pane. 2. Move the annotation to the desired location and left-click to place the annotation. Type the desired text and left-click to end annotation. Deletion Deletion of all measurements and annotations: 1.
Using Vscan gateway software The local storage is automatically detected by the Vscan gateway software. About local storage When saving a file to the computer a folder named “Archive” is created at the selected location. The folder “Archive” contains the examinations stored in separate folders with unique names. It is possible to disconnect the local storage to hide it from the list of devices in the Vscan gateway software. To disconnect a local storage: 1. Press Disconnect device .
Vscan gateway software To create a report: 1. Select either an examination containing still images or one or several still images from an examination. 2. Press Report . If the examination has a report from before the user is asked to whether overwrite the report or not. NOTE: • Press Yes create a new report, the existing report will be deleted. • Press No to keep the existing report. No new report is created.
Using Vscan gateway software The following information is displayed: • Patient name: auto-populated from the Assign patient information screen. To change this information, see ‘Patient information’ on page 4-23. • Patient ID: auto-populated from the Assign patient information screen. To change this information, see ‘Patient information’ on page 4-23. • Examination number: determined by the system. • Examination time: determined by the system.
Vscan gateway software Setup screen This screen is divided in three tabs: • Home: provide information about the Vscan gateway software and connected Vscan. From this screen the user can also: • Run a wizard to check basic software controls and configure the Insite service tool. • Change the language for the Vscan gateway software and manual. • Send request for service to GE (Hotline). • Save log file for Vscan gateway software or connected Vscan. • Configure the report function.
Using Vscan gateway software 3. Fill inn the form. Fields and sections marked with an asterisk are required. 4. Press Send. Generating a log file In the event of error or system malfunction log files for the Vscan gateway and any Vscan that has been connected to the computer are available for GE service through the hotline system.
Vscan gateway software -LogFile-T Report settings 1. Press Setup . 2. In the Home page press Report Settings. The Report settings window is displayed. 3. The following can be adjusted: NOTE: • Report type: select a report template. • Report location: to change the storage location for the report, press the button next to the storage path, browse to the desired location and press OK.
Using Vscan gateway software The Software page in the Setup screen is displayed showing the available software update for the selected device. 2. Select the Vscan gateway software device and press Install. The Vscan gateway software is closed and a confirmation window is displayed. 3. Press OK. The installation process is started. 4. On the last screen, check the option I would like to launch Vscan gateway software and press Finnish. The new version of Vscan gateway software is started.
Vscan gateway software CAUTION • Ensure that the power supply is connected to the Docking station while upgrading the software. • DO NOT TURN OFF the Vscan unit while upgrading the software. Do not turn off or disconnect power during the update. Doing so could cause an error requiring the device to be sent for repair. 4. Press OK. The software update files are copied and unpacked to the Vscan microSD card. 5. The Vscan is running a system test.
Using Vscan gateway software 1. Make sure the battery is fully charged. 2. Remove the Archive microSD card from the Vscan (see page 2-17). 3. Insert the Update microSD card in the Vscan (see page 2-18). 4. Place Vscan on the Docking station and make sure that the power supply is connected to the Docking station. 5. Open the display to start the Vscan. The Vscan is running a system test. • If the test failed, close the display to turn off the system and contact service.
Vscan gateway software The Vscan is running a system test. 4-34 • If the test failed, close the display to turn off the system and contact service. • If the test passed the Vscan is ready for use.
Chapter 5 Vscan configuration Contents: ‘Config menu’ on page 5-2 Vscan – User Manual GM092207 02 5-1
Vscan configuration Config menu The following settings and functions are available from the Config menu.
Config menu Item Choice Note Shutdown System shutdown procedure to use when cleaning Vscan. Activation Displays the Activation key screen (see page 2-24) System setup adjustment 1. Press Menu. 2. In the main menu, use / items and highlight Config ( to browse through the menu ). 3. Press Select. The Config menu is displayed. 4. Use / ) to browse through the menu items and highlight Setup . 5. Press Select. The Setup screen is displayed. 6. Use / to highlight the item to adjust. 7.
Vscan configuration 5-4 Vscan – User Manual GM092207 02
Chapter 6 Vscan maintenance Contents: ‘System care and maintenance’ on page 6-2 ‘Inspection’ on page 6-3 ‘Cleaning and disinfection’ on page 6-4 ‘Reinstallation of the factory software’ on page 6-7 ‘Troubleshooting’ on page 6-9 Vscan – User Manual GM092207 02 6-1
Vscan maintenance System care and maintenance CAUTION The user must ensure that safety inspections are performed at least every 12 months according to the requirements of the patient safety standard IEC 60601-1 / UL60601-1. Only trained persons are allowed to perform the safety inspections mentioned above. The Vscan requires regular care and maintenance to function safely and properly.
Inspection Inspection Inspecting the Vscan CAUTION If any defects or damages are found on the control unit, the probe or its cable, DO NOT use the Vscan. Contact GE service.
Vscan maintenance Cleaning and disinfection Cleaning Cleaning the control unit, the display and the Docking station Make sure the Docking station is disconnected from the AC adapter before cleaning. 1. Switch off the Vscan from the Shutdown menu (see page 3-2). 2. Moisten a soft, non-abrasive cloth with a mild, general purpose, non-abrasive soap and water solution. 3. Wipe the Vscan and the Docking station. 4. Wipe dry with a soft towel.
Cleaning and disinfection Disinfection Recommended germicides In order to provide users with options in choosing a germicide, GE routinely reviews new medical germicides for compatibility with the Vscan 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 transducer. The following germicides can be used on the Vscan and its probe.
Vscan maintenance Disinfecting the probe 1. After cleaning, the probe and cable may be wiped with a tissue sprayed with a recommended germicide. WARNING Use additional precautions (e.g. gloves and gown) when decontaminating an infected probe. The probe should not be exposed to the germicide longer than specified to achieve the desired effect. DO NOT soak or saturate the probe with solutions containing alcohol, bleach, ammonium chloride compounds or hydrogen peroxide.
Reinstallation of the factory software Reinstallation of the factory software A microSD card with the factory software is provided in a sealed envelope in case a clean re-installation of the factory software is required. CAUTION IMPORTANT! Reinstallation of the factory software should only be done in agreement with service. Procedure 1. Make sure the battery is fully charged. 2. Remove the Archive microSD card from the Vscan (see page 2-17). 3.
Vscan maintenance CAUTION Do not turn off the Vscan or disconnect the power supply during the installation. Doing so could cause an error requiring the device to be sent for repair. The unit is turned off automatically when the installation is completed. 7. Remove the Factory software microSD card from the Vscan and reinsert the Archive microSD card. The Vscan is now reset with the factory software and needs to be activated again (see page 2-22).
Troubleshooting Troubleshooting Vscan troubleshooting Problem Vscan has no power. Vscan is not charging. Possible cause Solution Battery not inserted. Insert battery (see page 2-15). Battery not charged Charge the battery (see page 2-11) Battery defect or end of life Contact GE Service (see page 1-7). Broken battery connection Contact GE Service (see page 1-7). Battery not inserted. Insert battery (see page 2-15). Battery defect or end of life Contact GE Service (see page 1-7).
Vscan maintenance Vscan gateway software troubleshooting Problem No connection between Vscan and Vscan gateway software Vscan movies are not playing in Vscan gateway software. 6-10 Possible cause Solution Vscan is not properly docked on the docking station. Ensure the Vscan is properly docked. The Docking connectors on the Vscan and the Docking station are dirty. Verify that the docking connectors on the Vscan and on the Docking station are clean. Remove any dust or foam rests from the connectors.
Troubleshooting Problem Vscan display is flashing while scanning Vscan – User Manual GM092207 02 Possible cause Solution Automatic reduction of the frame rate due to increase of the operating temperature after extended scanning. Restart the Vscan to enable normal frame rate again.
Vscan maintenance 6-12 Vscan – User Manual GM092207 02
Chapter 7 Safety Contents ‘Introduction’ on page 7-2 ‘Owner responsibility’ on page 7-3 ‘Important safety considerations’ on page 7-5 ‘Probe overview’ on page 7-20 ‘Maximum probe temperature’ on page 7-21 ‘Device labels and symbols’ on page 7-22 Vscan – User Manual GM092207 02 7-1
Safety Introduction This chapter describes the important safety measures which should be taken before operating the Vscan. Procedures for simple care and maintenance of the Vscan 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 It is the responsibility of the owner to ensure that anyone operating the Vscan 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.
Safety and degradation in system performance. All modification must be done by a GE qualified person. Software upgrade following GE recommendations can be done by the user.
Important safety considerations Important safety considerations 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 the Vscan, and to alert them to the extent to which injury and damage may occur if the precautions are not observed.
Safety CAUTION Be certain to ensure privacy data of patient information. Diagnostic information The images and calculations provided by the system are intended for use by competent users, as a diagnostic tool. They are explicitly not to be 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 utility 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 live pads. 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 ‘Vscan maintenance’ on page 6-1.
Safety To avoid injury • Do not remove the Vscan's protective covers. No user-serviceable parts are inside. If servicing is required, contact GE service. • Do not spray or place liquids on or above the Vscan. Conductive fluids seeping into the active circuit components may cause short circuiting, which could result in an electrical fire. Pacemaker hazard The possibility of the system interfering with pacemakers is minimal.
Important safety considerations 1. Patient environment Figure 7-1. Patient environment Allergic reactions to latex-containing medical devices Due to reports of severe allergic reactions to medical devices containing latex (natural rubber), the FDA advises health-care professionals to identify latex-sensitive patients, and be prepared to treat allergic reactions promptly.
Safety AII types of electronic equipment may characteristically cause electromagnetic interference with other equipment, transmitted either through air or connecting cables. The term Electromagnetic Compatibility (EMC), indicates the capability of the equipment to curb electromagnetic influence from other equipment, while at the same time not affecting other equipment with similar electromagnetic radiation.
Important safety considerations equipment the user should be attentive to unexpected device behavior which may be caused by such radiation. The ultrasound unit is intended for use in the electromagnetic environment specified in the tables below. The user of ultrasound unit should assure that the device is used in such an environment.
Safety Electromagnetic emissions Guidance and manufacturer’s declaration – electromagnetic emissions. Emissions test Compliance Electromagnetic environment - guidance RF emission CISPR 11 EN55011 Group 1 The ultrasound unit uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
Important safety considerations Guidance and manufacturer’s declaration – electromagnetic immunity. Immunity test Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 IEC 60601 test level < 5% UT (>95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles Compliance level Compliance for all test levels. Controlled shutdown with return to pre-disturbance condition after operator’s intervention.
Safety Guidance and manufacturer’s declaration – electromagnetic immunity Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidancec Portable and mobile RF communications equipment should be used no closer to any part of the ultrasound unit, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Important safety considerations Separation distances Recommended separation distances between portable and mobile RF communications equipment and the ultrasound unit The ultrasound unit is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
Safety Acoustic output Definition of the acoustic output parameters Thermal Index TI is an estimate of the temperature increase of soft tissue or bone. There are three thermal index categories: • TIS: Soft tissue thermal index. The main TI category. Used for applications that do not image bone. • TIB: Bone thermal index (bone located in a focal region). Used for fetal application. • TIC: Cranial bone thermal index (bone located close to the surface). Used for transcranial application.
Important safety considerations Display Accuracy and Acoustic Measurement Uncertainties The display accuracy and measurement precision of the output display are summarized in the table below. Accuracy of the output display (TI, MI) parameters depends on the measurement system precision, the acoustic model used to calculate the parameters and variation in the acoustic output of probes and systems.
Safety automatically, and should assist in reducing the patient exposure time. Changing imaging modes Acoustic output depends on the imaging mode selected. The choice of mode (black and white or color imaging) determines whether the ultrasound beam is stationary or in motion. This greatly affects the energy absorbed by the tissue (see ‘Acoustic Output Reporting Tables’ on page 8-2 for TI and MI values in black and white or color imaging.
Probe overview Probe overview Probe G3S Mode Black and white Color Vscan – User Manual GM092207 02 Technical data Frequency: Foot print: 1.7–3.
Safety Maximum probe temperature Max Temp (Simulated use) Probe G3S 40.0 NOTE: Max Temp (Still air) 34.5 Lens temperature measured under following conditions per IEC 60601-2-37: 1. Thermocouple was placed at the geometric center of the lens. 2. a: Thermal phantom at 37 °C for non-external probes. b: Thermal phantom at 33 °C (or 23 °C) for external probes. (Temperature rise is measured and added to 33 °C if the phantom is at 23 °C).
Device labels and symbols Device labels and symbols The following table describes the purpose of safety labels and other important information provided on the equipment. Label Vscan – User Manual GM092207 02 Purpose Location CE mark Vscan control unit This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately.
Safety Label MFD 7-22 Purpose Location Rechargeable, use only Vscan battery (GM-BAT).
Device labels and symbols Vscan – User Manual GM092207 02 7-23
Chapter 8 Appendix Contents: ‘Acoustic Output Reporting Tables’ on page 8-2 ‘Measurement accuracy’ on page 8-7 ‘Medical Ultrasound Safety’ on page 8-8 Vscan – User Manual GM092207 02 8-1
Appendix 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: IEC FDA Meaning—IEC 60601-2-37 / FDA & NEMA UD2, UD3 Acoustic Attenuation Coefficient / Derating factor (usually 0.
Acoustic Output Reporting Tables IEC FDA Meaning—IEC 60601-2-37 / FDA & NEMA UD2, UD3 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 Thermal Index / (same) Pulse Duration / (same) -12 dB Output Beam Dimensions / (same) Distance from the Source t
Appendix Operating Conditions All table entries are with the operating conditions specified at the end of the table.
Acoustic Output Reporting Tables Acoustic Output Reporting Tables for Track 3/IEC 60601-2-37 Transducer Model: G3S Operating Mode: black and white a), b) see ‘Explanation of Footnotes’ on page 8-3.
Appendix Transducer Model: G3S Operating Mode: color a), b) see ‘Explanation of Footnotes’ on page 8-3.
Measurement accuracy Measurement accuracy The measurement accuracy of the system is validated on images of an ultrasound phantom with speed of sound of 1540 +/-10 m/s. For in-vivo ultrasound images the accuracy may be slightly reduced due to variations of the speed of sound in different kinds of tissue. Distance measurement The distance measurement accuracy is 7% of the measured distance, for distances >1 cm.
Appendix Medical Ultrasound Safety The user should be familiar with the enclosed document “Medical Ultrasound Safety”, published by AIUM (American Institute of Ultrasound in Medicine). This document is acceptable to FDA as meeting the content of the ALARA educational program. ALARA is an acronym for the principle of prudent use of diagnostic ultrasound by obtaining the diagnostic information at an output that is As Low As Reasonably Achievable. NOTE: This document is only available in English.
Index A M Auto freeze, 3-8 AutoCycle, 3-8 Maintenance, 6-1 MicroSD card Insert, 2-17 Installation, 2-21 Remove, 2-17 B Battery Charge, 2-11 Insert, 2-15 Installation, 2-21 Level indicator, 2-14 Remove, 2-15 Specifications, 2-16 Black and white imaging, 3-6 C Cleaning, 6-4 Color aliasing, 3-8 Color imaging, 3-7 Configuration, 5-1 Contraindication, 1-3 P Package contents, 2-2 Presets, 3-6 R Regulatory Requirements, i-1 S Examination folder, 3-5 Safety Acoustic output, 7-16 Electrical hazard, 7-7 El
