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1. 6 7 Troubleshooting Vscan troubleshooting 6 9 Vscan gateway software troubleshooting 6 10 Chapter 7 Safety Introduction Owner responsibility Notice against user modification 7 3 Important safety considerations Patient safety 7 5 Personnel and equipment safety 1 1 Electromagnetic Compatibility EMC 7 9 Acoustic output 7 16 Environmental protection 7 18 Probe overview Maximum probe temperature Device labels and symbols Chapter 8 Appendix Acoustic Output Reporting Tables Definitions symbols and abbreviations 8 2 Acoustic Output Reporting Tables for Track 3 IEC 60601 2 37 8 5 Measurement accuracy Distance measurement 8 7 Area measurement 8 7 Medical Ultrasound Safety Index Vscan User Manual I 7 GM092207 02 Vscan User Manual GM092207 02 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 1 1 GM092207 02 Introduction General description
2. i 1 Country Specific Approvals 2 Certifications 2 Classifications 2 Class Il Equipment 2 Type BF Applied part I 3 Environmental requirements for the unit I 3 Original Documentation I 3 Table of Contents Chapter 1 Introduction General description Principles of operation 1 2 Safety eee eee eee 1 2 Indication for use eee ee ee eee 1 3 Contraindication eee e ee eee ee eee 1 3 Warnings Conventions used in this manual Contact Information Contacting GE Ultrasound 1 7 Global ultrasound support center phone numbers 1 8 Manufacturer 1 11 Chapter 2 Preparing the Vscan for use Package contents System description System overview 2 5 Battery Power plug adapter 2 12 Charging the battery using the Docking station 2 12 Charging the battery using the External battery charging compartment 2 13 Batte
3. 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 3 10 Vscan User Manual GM092207 02 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 NOTE Storage of 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 gt to display the acquisition as a movie Press gt to play pause the movie To start scanning again press Select Images and voice notations for the current examination are stored to the microSD card on a dedicated examination folder Each time the system is restarted a new examination is created The examination number is displayed on the screen Pressing Store will store to the microSD card either of these e A single frame when in freeze e Amovie when in live Single frame storage Vscan User Manual GM092207 02 1 While scanning press Select to freeze the image and sc
4. Important safety considerations a a Sei v4 N I A 1o m i LJ l 0 i I I 1 7 ee ee ee M 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 Latex is a component of many medical devices including surgical and examination gloves catheters incubation tubes anesthesia masks and dental dams Patient reaction to latex has ranged from contact urticaria to systemic anaphylaxis For more details regarding allergic reaction to latex refer to FDA Medical Alert MDA91 1 March 29 Electromagnetic Compatibility EMC NOTE Vscan User Manual GM092207 02 This unit carries the CE mark It complies with regulatory requirements of the European Directive 93 42 EEC concerning medical devices It also complies with emission limits for a Group 1 Class B Medical Device as stated in EN 60601 1 2 IEC 60601 1 2 Electrical medical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this manual 7 9 Safety 7 10 All types of electronic equipment may characteristically cause electromagnetic interference wit
5. Technical Publications Vscan Version 1 C 0470 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 C lt 0470 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 Manual status GM092207 02 26 February 2014 Manufacturer GE VINGMED ULTRASOUND AS Strandpromenaden 45 N 3191 Horten Norway Tel 47 3302 1100 Fax 47 3302 1350 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 This product complies with the regulatory requirement of the following Standard Directive 93 42 EEC Medical Devices Directive MDD EN55011 Emitted noise according to Class B requir
6. e IEC 60601 2 37 Medical electrical equipment Part 2 37 Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment MI is the estimated likelihood of tissue damage due to cavitation The absolute maximum limits of the MI is 1 9 as set by the FDA 510 k guidance of September 9 2008 The Ispta is the Spatial Peak Temporal Average Intensity The absolute maximum limit of Ispta is 720 mW cm as set by the FDA 510 k guidance of September 9 2008 Acoustic output and display on the Vscan 7 16 MI and TI values are displayed on the scanning screen For all imaging modes of Vscan TIS equals TIB and is displayed as TI The Vscan chooses the correct category based on mode of operation and chosen application and presents only one TI to the operator It is therefore important that the operator chooses the right application The maximum possible MI and Ispta on the Vscan is within the limits set in Track 3 in the FDA 510 k guide of September 9 2008 MI lt 1 9 and Ispta lt 720 mW cm Vscan User Manual GM092207 02 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
7. 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 These echo signals are amplified and processed by several analog and digital circuits having filters with many frequency and time response options transforming the high frequency electrical signals into a series of digital image signals which are stored in memory Once in memory the image can be displayed in real time on the image monitor A probe is an accurate solid state device providing multiple image formats The digital design and use of solid state components provides highly stable and consistent imaging performance with minimal required maintenance Sophisticated design with computer control offers a system with extensive features and functions which is user friendly and easy to use Safety Read and understand all instructions in the User s Manual before attempting to use the ultrasound unit Keep the manual with the equipment at all time Periodically review the procedures for operation and safety precautions All information in Chapter Safety on page 7 1 should
8. contact 11 the IT administrator Fill in the necessary information and press Submit changes Once the configuration is saved close the nsite contiguration tool window Press Next and step through the next pages to check the basic software controls e g audio replay image adjustment controls and movie controls Refer to Vscan gateway software troubleshooting on page 6 10 if you experience any issues during the functionality check The Vscan gateway software is now activated and ready for use If you do not have Internet access you can still activate Vscan and Vscan gateway software by contacting GE Service as described below For Vscan only activation when you have no computer access see Activation of the Vscan without Vscan gateway software on page 4 16 ls After installation of Vscan gateway software double click on the Vscan gateway software icon ob on the desktop to start the program If the icon is not on your desktop you can typically find it by selecting Start Programs GE Vscan gateway software The Language window is displayed Vscan User Manual GM092207 02 Vscan gateway software installation Application Language User Manual Language o Cancel 2 Select the desired language for the program and for the user manual and press OK The Vscan gateway software activation window is displayed GE Healthcare Activation You need to activate your device before use
9. 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 Devices which intrinsically transmit radio waves such as cellular phones radio transceivers mobile radio transmitters radio controlled toys and so on should preferably not be operated near the unit See page 7 15 about the recommended minimum separation distances between portable and mobile RF communications equipment and the ultrasound unit Any electrical device can unintentionally emit electromagnetic waves However minimum device separation distances cannot be calculated for such unspecified radiation When the ultrasound unit is used adjacent to or in close proximity to other Vscan User Manual GM092207 02 Vscan User Manual GM092207 02 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 electronic equipment RF emission Group 1 The ultrasound unit uses RF energy only fo
10. 02 Preparing the Vscan for use The microSD card handling recommendations The microSD cards are sensitive electronic devices e Donot bend the microSD cards or subject them to shocks or vibrations 2 20 Vscan User Manual GM092207 02 First time use First time use Before the Vscan can be used the following steps must be done e Install and charge the battery e 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 Vscan User Manual 2 21 GM092207 02 Preparing the Vscan for use Activation Configuration Language selection 2 22 Vscan activation There are three possible scenarios to activate the Vscan 1 Scenario 1 preferred online activation of Vscan and or Vscan gateway e Install Vscan gateway software see Installation of the Vscan gateway software on page 4 5 e Activate your Vscan and Vscan gateway software from the Vscan web portal on the Internet see Online activation on page 4 7 2 Scenario 2 offline activation of Vscan and or Vscan gateway e Install Vscan gateway software see Installation of the Vscan gateway software on page 4 5 e Activate your Vscan and Vscan gateway software by contacting GE Service see page 1 8 for phone numbers then see Offline activation on page
11. 09 2011 14 45 36 Movie Devices Exam 5 VH010018JN 14 09 2011 15 15 VHO10018IN 15 09 2011 14 46 18 Movie Exam 7 VH010018JN 15 09 2011 10 26 R A 3 TOU TOO YOU 15 09 2011 14 46 28 ID 123 Movie Exam 9 VH010018JN Movie Exam 10 VH010018JN i 15 09 2011 12 04 i 15 09 2011 14 47 19 Exam 12 0018JN 15 09 2011 13 32 15 09 2011 14 47 37 Image Exam 13 VH010018JN 15 09 2011 14 48 05 15 09 2011 14 10 15 09 2011 14 48 13 Exam 15 VH010018JN 15 09 2011 15 17 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 Sort examination by date patient name or patient ID Examination filter filter examinations based on a user defined filter 7 Gallery Menu e Open eai open a local storage e Save as LJ save the selected examination or file to a folder e Report od create a report in PDF format e E mail a send the selected file s by e mail Microsoft Outlook required 8 Image menu e lt 4 gt navigate between the files in the current examination e Dist Area distance and area measu
12. 4 72 3 Scenario 3 Vscan activation only when not installing the Vscan gateway software e See Activation of the Vscan without Vscan gateway software on page 4 16 Scenario 1 is recommended if you have access to a computer with an Internet connection After activation the Vscan needs to be configured see below After activation the Vscan Setup wizard is started 1 Use F to browse through the available languages until the desired language is highlighted Vscan User Manual GM092207 02 Adjust time Adjust date Vscan User Manual GM092207 02 Vscan activation Setup Your Yscan O End Language Congratulations with your new Yscan device Before first time use you will need to setup several settings English Espa ol Fran ais Italiano Press Select when done Press to continue the configuration The Time screen is displayed Use lt to navigate between hours minutes and seconds Use Y or Rotate and press Select to set each item Setup Your Yscan 4d End Time GE 55 05AM Press gt to continue the configuration The Date screen is displayed Use lt to navigate between days months and years Use V or Rotate and press Select to set each item 2 23 Preparing the Vscan for use Setup Your Vscan ETE Date 19 JUN 72009 2 Press gt to continue e If the activation key was obtained online the Vscan is then rea
13. 60601 1 Type and degree of protection against electric shock e Vscan is internally powered battery operated during hand held scanning e The AC adapter is Class Il e Vscan has type BF Applied Part e Degree of protection against harmful ingress of water Vscan parts and accessories except probe tip ordinary equipment IPx0 Probe tip IPX1 EQUIPMENT in which protection against electric shock does not rely on BASIC INSULATION only but in which additional safety precautions such as DOUBLE INSULATION or REINFORCED INSULATION are provided there being no provision for protective earthing or reliance upon installation conditions Vscan User Manual GM092207 02 Type BF Applied part TYPE BF APPLIED PART providing a specified degree of protection against electric shock with particular regard to allowable LEAKAGE CURRENT Patient leakage current lt 100 microA lt 500 microA Environmental requirements for the unit Humidity Temperature non condensing Air Pressure Operational 10 40 C C 30 80 700 1060hPa 1060 hPa Non operational Eak C 30 90 hPa NOTE Avoid exposing the unit to saline moisture In case of exposure to saline moisture clean the unit as described on page 6 4 Original Documentation e The original document was written in English Vscan User Manual l 3 GM092207 02 Vscan User Manual GM092207 02 Table of Contents Conformance Standards
14. DC adapter 3 Press the button and turn the plug clockwise until it locks in place Charging the battery using the Docking station 1 Place the Vscan on the Docking station 2 12 Vscan User Manual GM092207 02 CAUTION Battery 2 Plug the charger GM CHA plug into the charger connector on the Docking station x l A eS e Plug the AC DC adapter into the electrical outlet 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 CAUTION Vscan User Manual GM092207 02 Insert the battery GM BAT in the compartment until the lid clicks in place Plug the charger GM CHA plug into the charger connector on the external battery charging compartment Plug the AC DC adapter into the electrical outlet 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 2 13 Preparing the Vscan for use Battery level indicator The battery level indicator is displayed on the header The following icons are displayed ee e
15. Delete Examination 3 14 File 3 14 Disinfection 6 4 E Examination folder 3 5 G Gel 3 3 Indication for use 1 3 Information Requesting 1 7 Inspection 6 3 L Labels 7 27 Vscan User Manual GM092207 02 Index Maintenance 6 7 MicroSD card Insert 2 17 Installation 2 27 Remove 2 17 P Package contents 2 2 Presets 3 6 R Regulatory Requirements i 1 S Safety Acoustic output 7 16 Electrical hazard 7 7 Electromagnetic Compatibility 7 9 Equipment safety 7 7 Explosion hazard 7 7 Mechanical hazard 7 6 Pacemaker hazard 7 8 Patient safety 7 5 Personnel safety 7 7 Probe temperature 7 20 Switching on off 3 2 System description Control unit 2 5 Display 2 6 T Troubleshooting 6 9 V Vscan Gateway Computer requirements 4 4 Connection to Vscan 4 18 Installation 4 5 Overview 4 20 Setup screen 4 28 Index 1
16. 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 6 1 GM092207 02 Vscan maintenance system care and maintenance CAUTION 6 2 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 To ensure that the Vscan constantly operates at maximum efficiency we recommend that the following procedures be observed as part of the customer s internal routine maintenance program Vscan User Manual GM092207 02 Inspection Inspection Inspecting the Vscan CAUTION If any defects or damages are found on the control unit the nN probe or its cable DO NOT use the Vscan Contact GE service Examine the following on a monthly basis or whenever there is a reason to assume that any issue may have occurred e Connectors on cables for any mechanical defects e Entire length of electrical cables for cuts or abrasions e Equipment for loose or missing hardware WARNING To avoid electrical shock hazard do not re
17. Number manually in the Activation window The Serial number can be found on the label on the rear of the unit urar Stas Made in China GM000100 H45561BP 5 4 Press Retrieve Activation key s The Internet browser application is started and displays the Vscan Product Activation form not shown 5 Fill in the form and press Submit The Activation Success page is displayed showing the Activation key and System ID Activation Key System ID Vscan Activation Key ELE LY te J Po Gateway System ID 6 Highlight and copy Ctrl c the Activation key and System ID all text within the frame 7 Return to the Vscan gateway software activation and press Next Vscan User Manual 4 9 GM092207 02 Vscan gateway software The System ID and Activation key fields are displayed and automatically filled in Healthcare Activation If the field s below do not get automatically filled in return to the Activation Success page and re copy the key s Then go back to this window and press Paste If performing the activation with Service or if the Paste button does not work enter the key s manually Then press Next System ID ru i Activation key tte biter av lt lt Prev gt gt Next 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
18. 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 Your Gateway and Vscan are now activated Sy You can now undock your Vscan and start using it l Please note your Vscan Serial Number to be used in future service calls LE OK 9 Press OK The Insite configuration window is displayed Insite is a feature that integrates your Vscan with the GE digital services network so our technical support teams can remotely evaluate diagnose and resolve technical issues NOTE The installation of Insite does not give GE unauthorized access to your computer Each connection to your system by GE requires your approval GE s technical support teams are trained on proper patient privacy requirements in the event that any should occur 4 10 Vscan User Manual GM092207 02 Vscan gateway software installation GE Healthcare Insite Service Platform Configuration Please open the Insite Service Platform configuration dialog by pressing the Configure button below and then enter your location information under Location Configuration The fields in bold are required When completed please press Submit Changes to save the settings then close the configuration dialog before pressing Next to proceed Configure About InSite InSite is a feature that integrates your Vscan with the GE d
19. be read and understood before operating the ultrasound unit 1 2 Vscan User Manual GM092207 02 Indication for use Contraindication CAUTION Vscan User Manual GM092207 02 General description 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 The Vscan ultrasound unit is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye For USA only United States law restricts this device to sale or use by or on the order of a physician 1 3 Introduction Warnings To prevent damage of the equipment or injury to yourself or others read the following safety warnings before using the Vscan N 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 Stop using the unit if it emits smoke or noxious fumes Failure to do so may result in electrical shock or fire Stop using the unit if the casing is damaged including the probe Failure to do so may result in electrical shock Do not use the AC DC adapter if showing visible damages Use o
20. following messages are displayed on screen Scanner Upgrade Please wait while copying upgrade package to scanner Scanner Upgrade Ay Please wait for scanner installation to complete this may take several minutes When the installation is done the Vscan is turned off automatically Close the display 6 Open the display to restart the Vscan The Vscan is running a system test e If the test failed close the display to turn off the system and contact service e If the test passed the Vscan is ready for use NOTE The next time the Vscan is docked to the Vscan gateway software pressing Delete in the Software page will remove the installed upgrade from the list Vscan unit software update from a microSD card If the software update is provided on a microSD card proceed as follows 4 32 Vscan User Manual GM092207 02 CAUTION Vscan User Manual GM092207 02 Using Vscan gateway software Make sure the battery is fully charged Remove the Archive microSD card from the Vscan see page 2 17 Insert the Update microSD card in the Vscan see page 2 18 Place Vscan on the Docking station and make sure that the power supply is connected to the Docking station Open the display to start the Vscan The Vscan is running a system test e If the test failed close the display to turn off the system and contact service e Ifthe test passed the Consult user documentation screen is displayed Press
21. for a maximum period of one month All patient information will be permanently deleted at that point 1 5 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 The user should be aware of the product specifications and of the system accuracy and stability limitations These limitations must be considered before making any decision based on quantitative values If in doubt the nearest GE Ultrasound Service Office should be consulted Equipment malfunction or incorrect settings can result in measurement errors or failure to detect details in the image The user must become thoroughly familiar with the operation of the Vscan in order to optimize its performance and to recognize possible malfunctions Application training is available through the sales representative General precautionary advice for the use of diagnostic ultrasound in combination with ultrasound contrast agents CAUTION Mechanical hazards 7 6 Cardiac rhythm disturbances during cardiac studies using gas ultrasound contrast agents have been observed in the diagnostic range
22. 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 6 8 Vscan User Manual GM092207 02 Troubleshooting Troubleshooting Vscan troubleshooting O Poem Pessilocause O souon Vscan has no power 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 Vscan is not charging Battery not inserted not Battery not inserted Insert battery see page 2 15 Battery defect or end of life Contact GE Service see page 1 7 Broken battery connection Contact GE Service see page 1 7 Defect AC adapter or charger Contact GE Service see page 1 7 Temperature is outside the Ensure the ambient temperature specified limits is within the specified limits see page i 3 When opening the display the Connection broken during Contact GE Service see screen is white and nothing is software loading page 1 7 happening Parts of the image is missing Channels are missing Contact GE Service see when scanning page 1 7 Noise when moving the probe Defect probe cable Contact GE Service see cable page
23. indicated by italic type The following icons highlight safety issues as follow conditions or actions will cause severe or fatal personal injury t DANGER Indicates that a specific hazard exists that given inappropriate with or without substantial property damage conditions or actions can cause severe or fatal personal injury WARNING Indicates that a specific hazard exists that given inappropriate with or without substantial property damage CAUTION Indicates that a potential hazard may exist that given inappropriate conditions or actions can cause minor injury or property damage 1 6 Vscan User Manual GM092207 02 Contact Information Contact Information Contacting GE Ultrasound Internet USA Clinical Questions For additional information or assistance please contact your local distributor or the appropriate support resource listed on the following pages https vscan gehealthcare com http www gehealthcare com GE Healthcare TEL 1 800 437 1171 Ultrasound Service Engineering FAX 1 414 721 3865 9900 Innovation Drive Wauwatosa WI 53226 Please contact your local Applications or Sales Representative Accessories Catalog Requests Placing an order Vscan User Manual GM092207 02 To request the latest GE Accessories catalog or equipment brochures in the United States call the Response Center TEL 1 800 643 6439 In other locations contact your local Applications Sal
24. of interest 3 The following adjustment can be done to further improve the image quality Color gain Rotate Color gain amplifies the overall strength of echoes processed in the color area It allows control of the amount of color within a cavity NOTE Press Color fa to toggle color display on off Vscan User Manual GM092207 02 3 7 Using Vscan Color aliasing Auto freeze AutoCycle 3 8 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 If Vscan is idle for more than the Auto freeze time set in Config it enters in freeze mode to minimize overheating Press Select to start scanning again Vscan does not include an ECG interface as often found on larger ultrasound systems intended for cardiovascular applications The AutoCycle feature detects a complete cardiac cycle by analyzing the cyclicity of the ultrasound intensity data The resulting time stamps are used for storing and playing cineloops smoothly The AutoCycle feature should typically detect heart rates in the range 46 100 beats per minute If the detected heart cycle is outside this range or if the cyclicity quality is too poor a default 2 sec loop will be use
25. safety labels and other important information provided on the equipment Vscan control unit This symbol indicates that the waste of Vscan control unit electrical and electronic equipment must Vscan AC adapter not be disposed as unsorted municipal Vscan battery GM BAT waste and must be collected separately Please contact the manufacturer or other authorized disposal company to decommission your equipment Follow instructions for use Read and Vscan control unit understand all instructions in the User s Manual before attempting to use the ultrasound unit Vscan control unit Equipment Class II for products not relying Vscan AC adapter protective earth such as products having double or reinforced insulation Type BF Applied Part symbol see Vscan control unit Direct Current Vscan control unit Vscan AC adapter Alternating current Vscan AC adapter Output use only on Vscan device Vscan Docking station Vscan battery charging compartment Vscan charger GM CHA ve M eC H A Input use only Vscan charger GM CHA Vscan control unit Vscan User Manual 1 21 GM092207 02 Safety n n Rechargeable use only Vscan battery Vscan control unit I A GM BAT GM BAT Vscan Docking station AC adapter and charger Plastic bag containing the Vscan AC adapter and charger Manufacturer address Vscan control unit Vscan battery GM BAT Manufacturing date month year Vscan control unit Manufacturing date yymmdd
26. the ALARA educational program In addition to the AIUM document the sections Acoustic output and display on the Vscan on page 16 and System controls affecting acoustic output on page 7 17 should be studied carefully in order to implement ALARA Environmental protection System disposal 7 18 The device must not be destroyed by incineration Please return the device to your local GE representative for disposal Vscan User Manual GM092207 02 Probe overview Probe overview leaceananie 4 and white Frequency Iraak 1 7 3 8 MHz Color Foot print 13 x 19 mm Vscan User Manual 7 19 GM092207 02 Safety Maximum probe temperature Max Temp Max Temp oe eee eat use Eo ES air NOTE 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 NOTE Thermal phantom made with tissue mimicking material as referenced in IEC 60601 2 37 3 Probe placed upright in contact with above thermal phantom 4 Auto freeze capability is disabled 5 Lens temperature is monitored for 30 minutes 7 20 Vscan User Manual GM092207 02 Device labels and symbols Device labels and symbols The following table describes the purpose of
27. with the requirements of the valid version of IEC60601 1 1 If in doubt consult the technical service department or your local representative for GE Figure 4 1 Connection setup t CAUTION Accessory equipment connected to the analog and digital 1 Place the Vscan on the Docking station NOTE Plug the AC DC adapter into the electrical outlet to avoid loss of power during image viewing 2 Open the display to start the Vscan device 3 Connect Docking station to the computer using the USB 2 cable 4 Double click the Vscan gateway software icon on the computer desktop to start the application 4 18 Vscan User Manual GM092207 02 NOTE Vscan User Manual GM092207 02 Connection of Vscan to a computer The connected Vscan is automatically detected and mounted in Vscan gateway software To disconnect Vscan safely press the Disconnect device button in the Vscan gateway software Gallery screen or use the safe removal procedure from Windows 4 19 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 Online documentation screen displays online documentation and access to the Vscan web portal 4 20 Vscan User Manual GM092207 02 Gallery screen Bu Open Save As E Report H E mail an 4 Examinations Files Please enter filter SS 5
28. 1 7 No image displayed when Defect probe Contact GE Service see scanning page 1 7 Vscan User Manual 6 9 GM092207 02 Vscan maintenance Vscan gateway software troubleshooting No connection between Vscan is not properly docked on Ensure the Vscan is properly docked Vscan and Vscan the docking station gateway software The Docking connectors on the Verify that the docking connectors on the Vscan and the Docking station Vscan and on the Docking station are are dirty clean Remove any dust or foam rests from the connectors Vscan is not turned on Ensure that the Vscan is turned on see page 3 2 The microSD card is not inserted Make sure the microSD card is properly properly or missing inserted see page 2 17 USB cable is not connected Make sure the USB cable is properly connected in both ends USB port on the PC is defect Try another USB port on the PC Vscan movies are not The display adapter requirements See Computer requirements on playing in Vscan gateway are not met page 4 4 software The display adapter driver is not Update the display adapter driver to the up to date latest version New driver can be obtained from the computer or display adapter manufacturer Hardware acceleration for the Turn on hardware acceleration for the display adapter is turned off display adapter This can be done in the display adapter Control panel Properties dialog e Windows Vista Control Panel Appeara
29. 6 Vscan User Manual GM092207 02 E mail Vscan User Manual GM092207 02 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 Examination comment comments can be entered directly in this screen or from the Assign patient information screen Report location The storage location for the report created To change the location see Report settings on page 4 30 3 Select one of the following Store save the report Store and review store the report and open it Print store and print the report Cancel no report is created Image and voice notation files can be sent as e mail attachment compatible with Microsoft Outlook 1 Select one or several files to be sent by E mail 2 Press E mail An E mail is created with the selected file s attached 4 27 Vscan gateway software Setup screen This screen is divided in three tabs e Home provide information about the Vscan gateway software and connected Vscan From this screen the user can also e Run a wizard to check basic software controls and confi
30. 92207 02 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 Use only the AC adapter provided with the Vscan 1 Charger GM CHA 2 AC DC adapter Figure 2 5 The Vscan AC adapter charging compartment must be kept outside the patient f CAUTION The AC adapter the Docking station and the external battery environment refer to local regulation and EN 60601 1 oe 1 Patient environment Figure 2 6 Patient environment Vscan User Manual 2 11 GM092207 02 Preparing the Vscan for use on either the AC DC adapter the Docking station or the f CAUTION Do NOT touch simultaneously the patient and the charger plug external battery charger Power plug adapter 1 Select the country specific plug OOOVESG 0 O O O O BO 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 OahRWN 2 Place the plug onto the AC
31. A confirmation message is displayed select Yes to confirm deletion The selected items are deleted Save examinations to the computer 4 24 To save an examination or a file from a Vscan to the computer 1 Select the examination or the file to save and press Save as A Browse window is displayed Browse to the desired location where to store the files and press Save Vscan User Manual GM092207 02 About local storage NOTE Report NOTE Vscan User Manual GM092207 02 Using Vscan gateway software The local storage is automatically detected by the Vscan gateway software 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 El F My Computer S System C4 i s Data Be B My storage 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 Gp To reconnect the local storage to the Vscan gateway software 1 Press Open f A Browse window is displayed 2 Browse to the desired location e g My storage folder and press OK in the Browse window This folder should contain a subfolder Archive where the examinations are stored The local storage is displayed in the Device list of the Vscan gateway software T
32. Select The Gallery screen is displayed In the Gallery screen use lt B to browse to the examination to delete Press Menu Use lt q until Delete exam B is highlighted Press Select A confirmation dialog is displayed Press Select OK to delete the examination The newest active examination cannot be deleted Press Menu In the main menu use lt P to browse through the menu items and highlight Gallery j Press Select The Gallery screen is displayed In the Gallery screen use lt B to browse to the examination containing the file to delete In the selected examination use Y to browse to the file to delete Press Menu Use lt q gt until Delete file og is highlighted Press Select The file is deleted Vscan User Manual GM092207 02 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 4 1 GM092207 02 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 ona Docking station or by inserting the Vscan microSD card into a card reader not provided co
33. Store and Color fa simultaneously to start the installation Do not turn off the Vscan during the update 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 Close the display Remove the Update microSD card from the Vscan and reinsert the Archive microSD card Open the display to restart the Vscan 4 33 Vscan gateway software The Vscan is running a system test e Ifthe test failed close the display to turn off the system and contact service e Ifthe test passed the Vscan is ready for use 4 34 Vscan User Manual GM092207 02 Chapter 5 Vscan configuration Contents Config menu on page 5 2 Vscan User Manual 5 1 GM092207 02 Vscan configuration Config menu The following settings and functions are available from the Config menu Language English Norwegian German Dutch Italian French Spanish Portuguese Russian Greek Danish Swedish Japanese and Chinese dd MM yy Set current date Date format dd mmm yy dd mmm yyyy dd mm yy mm dd yyyy mm dd yy mm dd yyyy 01 AUG 09 01 AUG 2009 01 08 09 08 01 2009 08 01 09 08 01 2009 Time format 12 h 24h Auto Freeze 1 3 0r 5 min The Vscan enters in Freeze if idle for the time set Reset exam OK Cancel The microSD card must be number empty to reset the exam number to one Br
34. To simplify this process please dock your Vscan to this PC turn the device on by opening the lid and wait how until the SN is automatically detected approx 30 s If you are not able to dock your Vscan at this time you can enter the Serial Number manually in the field below PIN Serial Number where to find When both numbers above are filled in visit the Vscan activation portal http vscan gehealthcare com or click the retrieve activation key button below Click here if NOT able to use link above Contact Retrieve activation key s 3 Dock your Vscan on the Docking station and open the display to start Vscan Vscan User Manual 4 13 GM092207 02 Vscan gateway software NOTE After approximately 30 seconds the Serial Number of the Vscan should be automatically filled in the Activation window 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 urar Stas Made in China GM000100 H45561BP 5 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 The following will be required e The Vscan Serial Number written on the rear label of the control unit e Some user information Press Next in the Vscan gateway software activation wind
35. Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 IEC 60601 test level lt 5 Ur gt 95 dip in U7 for 0 5 cycle 40 Uy 60 dip in Uz for 5 cycles 70 Uy 30 dip in Uy for 25 cycles lt 5 Ur gt 95 dip in Uy for 5 Sec Compliance level Compliance for all test levels Controlled shutdown with return to pre disturbance condition after operator s intervention Power on switch 3 A m 50 and 60 Hz NOTE Uy is the a c mains voltage prior to application of the test level Vscan User Manual GM092207 02 Electromagnetic environment guidance Mains power quality should be that of a typical commercial or hospital environment If the user of the ultrasound unit requires continued operation during power mains interruptions it is recommended that the ultrasound unit is powered from an uninterruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment 7 13 Safety Guidance and manufacturer s declaration electromagnetic immunity IEC 60601 test Compliance Electromagnetic Immunity test level level environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the ultrasound unit includi
36. Vscan AC adapter Serial number Vscan control unit Batch number Vscan Docking station Vscan battery charging compartment Vscan charger GM CHA For indoor use only Vscan AC adapter Do not expose the battery to direct flame Vscan battery GM BAT Do not attempt to disassemble the battery Vscan battery GM BAT 1 22 Vscan User Manual GM092207 02 Device labels and symbols Vscan User Manual 1 23 GM092207 02 Chapter 8 Appendix Contents Acoustic Output Reporting Tables on page 8 2 Measurement accuracy on page 8 Medical Ultrasound Safety on page 8 8 Vscan User Manual 8 1 GM092207 02 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 Meaning IEC 60601 2 37 FDA amp NEMA UD2 UD3 Acoustic Attenuation Coefficient Derating factor usually 0 3 dB cm MHz 12db Output Beam Area Active aperture area Normalizing Coefficient Equivalent Aperture Diameter same Pulse Beam Width Beam diameter at 6 dB Equivalent Beam Diameter Acoustic Working Frequency Center frequency Pulse Average Intensity Attenuated Pulse Average Intensity Pulse Intensity Integral j Attenuated Pulse Intensity Integral pia lalz Temporal Average Intensity Ita a Z Attenuated Temporal Average Intensity at depth z lzptal2 Spatia
37. aning 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 d T Spray Pharmaceutical Innovations T Spray Il Pharmaceutical Innovations E ee ee C WARNING Use only compatible germicides In addition refer to the local national regulations Never use thinner benzene alcohol ethanol methanol or isopropyl alcohol abrasive cleaners or other strong solvents as these may cause damage to the control unit the display or the probe NOTE Follow the manufacturer s instructions for storage use and disposal of the disinfection solution Disinfecting the control unit 1 After cleaning the control unit may be wiped with a tissue sprayed with a recommended germicide Vscan User Manual 6 5 GM092207 02 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 germic
38. anual 1 11 GM092207 02 Introduction 1 12 Vscan User Manual GM092207 02 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 2 1 GM092207 02 Preparing the Vscan for use Package contents Make sure all items listed below are included in the package Vscan unit Storage microSD card installed in Vscan Soft bag USB 2 0 cable Battery GM BAT Coupling gel SD card adapter 2 2 Vscan User Manual GM092207 02 scan Getting Started 8 ie zs Vscan User Manual GM092207 02 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 2 3 Preparing the Vscan for use GE Heolthcare 1 Docking station 2 AC DC converter 3 Adapter plugs 2 4 Vscan User Manual GM092207 02 System description system description System overview The Vscan device 1 Probe G3S 5 Microphone 2 Control panel 6 Docking station connector 3 Display 7 Battery GM BAT and microSD card 4 Loud speaker compartment lid Figur
39. asurements and annotations are not automatically saved to disc Press Store to keep record of the measurements and annotations Distance measurement 1 Select Dist in the Review pane 2 Left click to place the first point Move the mouse to the end point and left click to place the end point The measurement value is displayed Vscan User Manual 4 23 GM092207 02 Vscan gateway software Area measurement Annotation Deletion NOTE Select Area in the Review pane Left click to place the first point Move the mouse to outline the area and left click to place the end point Select Annot in the Review pane 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 of all measurements and annotations 1 Right click on the image and select Delete all measurements in the context menu Single deletion 1 Place the mouse cursor over the measurement or annotation to delete Press Delete on the alphanumeric keyboard The annotation or measurement is deleted It is also possible to right click on the measurement or annotation to delete and select Delete highlighted measurement in the context menu Deletion of examinations and files NOTE Select the examination s or file s to be deleted Press Ctrl or Shift while selecting to do multiple selection Right click and select Delete in the context menu
40. ce through the hotline system If not able to send a request by using the Contact Hotline form in the Setup screen the user can save log files for the Vscan gateway software or connected Vscan devices and send them to GE by other means for instance by e mail To save a log file 1 Press Setup i 2 Inthe Home page press Save Logs Va Store logs from following devices X Vscan gateway software System ID VG0006200X Store Logs in directory D Documents and Settings 100006524 My Documents VG000620QXx Browse D A 3 Inthe Save logs window enter a description of the problem To save the log file to another location press Browse and navigate to another location 4 Press OK A zip file is saved The file can be sent to GE service as an attachment to an e mail The file naming convention for the log file is e Vscan gateway software log file lt System ID gt LogFile lt yyyy mm dd gt T lt hh mm ss gt e Vscan Vscan User Manual 4 29 GM092207 02 Vscan gateway software lt Serial No gt LogFile lt yyyy mm dd gt T lt hh mm ss gt Report settings 1 Press Setup B 2 Inthe Home page press Report Settings The Report settings window is displayed Va Report Settings Reports location USERPROFILE Vscan Gateway Reports Report Logo Set Report logo Recommended dimensions for the report header image file is at least 300 pixels high and 1000 wide OK f Cancel x 3 The followin
41. d caliper e Decrease Depth e Navigate through files in Gallery screen e Move color area and caliper e Increase Depth e Navigate through files in Gallery screen e Move color area and caliper Rotate function e Adjust Gain e Scroll in a movie when in pause Color imaging key e Enter exit color imaging Vscan User Manual 2 7 GM092207 02 Preparing the Vscan for use Store key e Store current acquisition movie or single frame e Press and hold to start voice notation Press any key to end voice notation Menu key e Enter the system menu e Move one level up in system menu e Exit the system menu 2 8 Vscan User Manual GM092207 02 System description The Docking station The Docking station is used to e Connect the Vscan to a computer e Charge the Vscan battery e Store the Vscan when not in use NOTE The Docking station is designed for in house use only Do not use the Docking station in ambulance or other vehicles 1 Vscan cradle 4 Charger GM CHA connector 2 Probe holder 5 USB port to computer 3 Vscan connector Figure 2 3 Docking station Vscan User Manual 2 9 GM092207 02 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 External battery charging compartment 2 10 Vscan User Manual GM0
42. d exceeds the applicable RF compliance level above the ultrasound unit should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the ultrasound unit Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m e See examples of calculated separation distances in next table 7 14 Vscan User Manual GM092207 02 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 The customer or the user of the ultrasound unit can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the ultrasound unit as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter m Rated maximum output 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz of transmitter d 1 24P d 1 24P d 2 34 P For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum o
43. d instead The detected start and stop times for the AutoCycle are not necessarily in phase with the QRS complex Since adequate cyclicity can only be expected in cardiac applications all other applications will use the default 2 sec loop Vscan User Manual GM092207 02 Taking measurements Measurements 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 2 Vscan User Manual GM092207 02 On a frozen image press Menu In the main menu use lt gt to browse through the menu items and highlight Distance Press Select A red caliper is displayed Use V lt q to move the caliper to the start point of the measurement Press Select to anchor the start point A new green caliper is displayed Use V lt q gt to move the caliper to the end point of the measurement Press Select to anchor the end point The performed measurement is displayed with the measured value next to the end point To store the image with measurement press Store B 3 9 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
44. dy for use e Ifthe 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 Setup Your Vscan ag A End Activation Serial No VHOLZ345RKX Enter key Use Y lt q to highlight the digit or character to enter and press Select The next entry in the activation key is highlighted 2 Repeat step 1 until all 25 entries in the activation key are filled in NOTE Select or on the keyboard to navigate through the activation key entries if changes need to be done A message is displayed on screen to confirm that the key is accepted 3 Press to end the configuration 2 24 Vscan User Manual GM092207 02 Vscan activation The Vscan is ready for use Vscan User Manual 2 25 GM092207 02 Preparing the Vscan for use 2 26 Vscan User Manual GM092207 02 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 3 1 GM092207 02 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 e Close t
45. e 2 1 The Vscan device Vscan User Manual 2 5 GM092207 02 Preparing the Vscan for use The display EXAM 4 Sun zopa 3 16 00 PM Cardiac MI Og THO 1 Black and white scanning screen default 1 i 2 6 Scanning information e Examination number page 3 5 e Current date e Current time e Scanning preset page 3 6 e Mechanical and Thermal Index page 7 16 Depth scale page 3 7 Orientation marker page 3 5 Header e Battery level indicator page 2 14 e Memory indicator of the microSD card page 2 19 Figure 2 2 EXAM 1 eefAprf2009 amp 37 AM Cardiac 4 Mi DS Oz reece Distance 4 K Gallery anfig Men Eni Menu screen displayed when pressing Menu 1 Menu items e New Exam create new examination page 3 5 e Distance make a measurement page 3 9 e Presets select an acquisition preset page 3 6 e Gallery review stored examinations page 3 11 e Config configure the Vscan page 5 1 Screens Vscan User Manual GM092207 02 System description The Control panel Select key e Freeze unfreeze in live mode e In a menu or a dialog select highlighted item e Press and hold to return to black and white imaging e Navigate in menus e Navigate through examinations in the Gallery screen e Move color area and caliper e Navigate in menus e Pause play movie e Navigate through examinations in the Gallery screen e Move color area an
46. e ee eee Low Battery prepare to recharge the battery or have a spare battery available Discharged battery recharge the battery or replace with a spare battery p es a edie 2 14 Vscan User Manual GM092207 02 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 Vscan User Manual 2 15 GM092207 02 Preparing the Vscan for use Battery GM BAT specifications Charging time About 1 5 hour Capacity About 1 hour and 15 min active use 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 In order to get maximum charging capacity with your Vscan battery GM BAT you should allow the battery to be fully charged and then fully discharged at least three times The unit can be used as normal during these cycles Once these initial charging discharging cycles are performed the following is applicable without reducing the life time of the battery e It is not necessary to completely discharge the battery before re charging it e It is possible to stop chargi
47. ements IEC60601 1 EN60601 1 Medical Electrical Equipment Part 1 General Requirements for Safety UL60601 1 CAN CSA C22 2 No 601 1 M90 IEC60601 2 37 Medical electrical equipment Part 2 37 Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment IEC1157 EN61157 Requirements for the declaration of the acoustic output of medical diagnostic ultrasonic equipment lIEC60601 1 2 Medical Electrical Equipment part 1 2 Collateral standard EN60601 1 2 Electromagnetic compatibility Requirements and tests IEC60601 1 4 Medical Electrical Equipment part 1 4 Collateral standard EN60601 1 4 Programmable electrical medical systems IEC60601 1 6 Medical Electrical Equipment part 1 6 Collateral standard Usability NEMA AIUM UD 3 Standard for real time display of thermal and mechanical acoustic output indices on diagnostic ultrasound equipment ISO10993 1 Biological evaluation of medical devices Vscan User Manual i 1 GM092207 02 Country Specific Approvals Certifications Classifications Class Il Equipment e JAPAN MHLW Approved Number 221ABBZX00252000 e CHINA SFDA SFDA I 20113231266 Product Standard Number YZB NOR 0732 2011 HP ER SG AY 8 Ja ARS LAY MARAT ARARAAIE bik ARAA ERs he Hii 800 810 8188 e KOREA KFDA 10 1194 e GE Vingmed Ultrasound is ISO 9001 and ISO 13485 certified The following classifications are in accordance with the IEC EN
48. er Manual GM092207 02 Acoustic Output Reporting Tables Acoustic Output Reporting Tables for Track 3 IEC 60601 2 37 Transducer Model G3S Operating Mode black and white TIB Index Label done Global Maximum Index Value gt fn a Ce a Fatma ia a on Focal Length FL cm FLy cm haaat max MI lpxs MImax Wem co EN Image Depth em Depth cm a a b see Explanation of Footnotes on page 8 3 Associated Acoustic Parameter os OoOo os BE Other Information w 2 D O O Operating Control Vscan User Manual 8 5 GM092207 02 Appendix Transducer Model G3S Operating Mode color TB maar Global Maximum Index Value 0 77 77 a P 2 P m a Pe m a a a O zE EN Pam eet TTT CFM 245 Dim of Aaprt xX em 1 39 39 Ea o_o e m w oz wmo pe p e Index Label TIC Associated Acoustic Parameter w E fem _ T Focal Length FLy cm 2D 0 39 z rR 0 21 a cm 2D 0 36 CFM 0 30 haaat max MI Ipaa Mina W cm o Image Depth em Depth cm Eo rs 5 eee oo w 5 O Q a b see Explanation of Footnotes on page 8 3 8 6 Vscan User Manual GM092207 02 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 vi
49. es or Service Representative To place an order order supplies or ask an accessory related question in the United States call the GE Access Center 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 Americas 1 8 Vscan User Manual GM092207 02 Contact Information Europe Middle East and Africa Region Location C Peers Conse a C Portugal Madrid Russia Moscow San Marino Milan Saudi Arabia Saudi Arabia Telephone O Vscan User Manual 1 GM092207 02 Introduction 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 0845 8503392 Bedford Ukraine 38 044 391 37 56 57 1 10 Vscan User Manual GM092207 02 Contact Information Asia and Pacific Region Location CO C O O O C Brunei Darussalam Telephone Manufacturer GE VINGMED ULTRASOUND AS Strandpromenaden 45 N 3191 Horten Norway Tel 47 3302 1100 Fax 47 3302 1350 Vscan User M
50. g can be adjusted e Report type select a report template e 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 e Report logo to insert a logo on the report header press Set report logo browse to the image file to insert and press Open NOTE Recommended image size 1000 x 300 pixels Image file format for the logo bmp jpg png and gif 4 Press OK to close the Report settings window Software update Software update for the Vscan gateway software and connected Vscan can be installed from the Setup screen Available software updates are automatically detected and an Update available button is displayed in the upper right corner of the screen when starting Vscan gateway software Vscan gateway software update 1 Press Update available 4 30 Vscan User Manual GM092207 02 Using Vscan gateway software The Software page in the Setup screen is displayed showing the available software update for the selected device Software Update Install Upgrade to version 0 0 21 of Vscan Gateway Version 0 0 21 Delete Information 2 Select the Vscan gateway software device and press Install The Vscan gateway software is closed and a confirmation window is displayed Updating Vscan gateway soltware Ed Yscan gateway software will be updated Do you want bo continue Cancel 3 Press OK The installat
51. gure the Insite service tool e Change the language for the Vscan gateway software and manual e Send request for service to GE Hotline e Save log file for Vscan gateway software or connected Vscan e Configure the report function e Diagnostics run diagnostic commands on the Vscan gateway software and connected Vscan e Software install software update for the Vscan gateway software and connected Vscan Service request NOTE This feature is not available in Japan To send a service request to GE 1 Press Setup B 2 Inthe Home page press Contact hotline The Contact GE screen is displayed Contact Information Last Xxx First XXX Phone 00 Ext E mail System ID NOT IN CRM Other System ID Problem Area Vscan hardware scan applications Vscan Gateway applications Other problem Problem Description xxxl Date Time of 05 27 2009 14 33 Now 977 characters left Problem Send Cancel Fields and sections that are marked with an asterisk are required 4 28 Vscan User Manual GM092207 02 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 servi
52. h other equipment transmitted either through air or connecting cables The term Electromagnetic Compatibility EMC indicates the capability of the equipment to curb electromagnetic influence from other equipment while at the same time not affecting other equipment with similar electromagnetic radiation Radiated or conducted electromagnetic signals can cause distortion degradation or artifacts in the ultrasound image which may impair the ultrasound unit s essential performance see page 7 15 There is no guarantee that interference will not occur in a particular installation If this equipment is found to cause or respond to interference attempt to correct the problem by one or more of the following measures e Re orient or re locate the affected device e Increase the separation between the unit and the affected device e Power the equipment from a source other than that of the affected device e Consult the service representative for further suggestions The manufacturer is not responsible for any interference or responses caused by the use of interconnecting cables other than those recommended or by unauthorized changes or modifications to this unit Unauthorized changes or modifications could void the user s authority to operate the equipment To comply with the regulations on electromagnetic interference all interconnecting cables to peripheral devices must be shielded and properly grounded Use of cables not properly
53. he default scanning mode NOTE As a safety precaution scanning is not possible when charging the battery and when connected to a computer 1 Start scanning 3 6 Vscan User Manual GM092207 02 Scanning 2 The following adjustments can be done to further improve the image quality NOTE NOTE Color imaging 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 If you change the probe position or adjust the Depth you may need to optimize again Depth Y Depth adjusts the field of view It increases the field of view to look at larger or deeper structures it decreases the field of view to look at structures near the skin line The depth setting is indicated on a depth scale Gain Rotate 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 Color imaging is a Doppler Mode intended to add color coded qualitative information concerning the relative velocity and direction of fluid motion within the black and white image 1 Press Color fa A color area is displayed on top of the black and white image 2 Use V lt q gt to move the color area over the region
54. he display Or e Use the Shutdown menu NOTE 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 Inthe main menu use lt B to browse through the menu items and highlight Config Pd 3 Use lt gt to browse through the menu items and highlight Shutdown 0 4 Press Select 3 2 Vscan User Manual GM092207 02 Scanning scanning General scanning recommendations Before each use e Inspect the probe see Inspecting the probe on page 6 3 After each use e Inspect the probe see Inspecting the probe on page 6 3 e Clean the probe see Disinfection on page 6 5 e f required disinfect the probe see Disinfection on page 6 5 CAUTION If any damage is found on the probe or its cable DO NOT use the Vscan Contact GE service Use of gel In order to assure optimal transmission of energy between the patient and the probe a conductive gel must be applied on the probe lens CAUTION Do not apply gel to the eyes If there is gel contact to the eye A N flush eye thoroughly with water Vscan User Manual 3 3 GM092207 02 Using Vscan Coupling gels should not contain the following ingredients as they are known to cause probe damage e Methanol ethanol isopropanol or any other alcohol based product e Mineral oil e lodi
55. he image having the orientation V mark on the scanning screen 1 Orientation marking on probe 2 Orientation marking on screen Patient examination Vscan User Manual GM092207 02 When scanning several patients make sure to create a new examination between each patient To create a new examination 1 Press Menu 2 Use lt gt to browse through the menu items and highlight New exam PA 3 Press Select A new examination is created The examination number is displayed on the screen 3 5 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 lt gt to browse through the menu items and highlight Presets 2 3 Press Select The Preset menu is displayed 4 Browse to the desired preset and press Select cies s we Aorta Thoracic Pleural motion and fluid detection Abdominal Liver Kidney Gall bladder Spleen Urology Peripheral vascular Obstetrics Black and white imaging Black and white imaging is intended to provide two dimensional images and measurement capabilities concerning the anatomical structure of soft tissue Black and white is t
56. he report function was introduced in the Vscan gateway software version 1 2 A report containing still images patient ID patient information and comments can be created The report can be printed and stored as a PDF file Examinations with an existing report are marked with a R The following is configurable see Report settings on page 4 30 e The logo on the report heading e The storage location of the reports 4 25 To create a report 1 Select either an examination containing still images or one or several still images from an examination 2 Press Report F If the examination has a report from before the user is asked to whether overwrite the report or not Report information The file already exists 00006524 PDF Gpen Do you want to overwrite it N A e Press Yes create a new report the existing report will be deleted e Press No to keep the existing report No new report is created NOTE If you wish to keep the existing report you may press Open and save the existing report as a new PDF with a different name and then press Yes to create a new report The Report information screen is displayed Report information Patient Patient ID Exam Exam time ExamComment Report location Number of images selected 1 Exam 000014 Not all items are stored in report still images only What do you want to do n A a E a A Store Store and review Print Cancel 4 2
57. hoos 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 The user manual can be installed after Vscan gateway software is installed and activated 4 Press Next The Complete window is displayed 4 6 Vscan User Manual GM092207 02 Vscan gateway software installation InstallShield Wizard Complete 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 e 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 e Offline activation contact the GE Service see page 1 8 for phone numbers to get a Vscan key and Vscan gateway System ID see Offline activation on page 4 12 NOTE To only activate Vscan see Activation of the Vscan without Vscan gateway software on page 4 16 Online activation Pre requisite a computer with Vscan gateway software installed and Internet access 1 After installation of Vscan gateway software double click on the Vscan gateway software icon on the desktop
58. ide 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 Neurological use on patients with this disease must be avoided If the Vscan becomes contaminated there is no adequate disinfecting means WARNING CREUTZFELD JACOB DISEASE 6 6 Vscan User Manual GM092207 02 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 nN 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 Insert the Factory software 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 After about 30 seconds the Consult user documentation screen is displayed 6 Press Store and Color fa simultaneously to start the installation Vscan User Manual 6 7 GM092207 02 Vscan maintenance during the installation Doing so could cause an error t CAUTION Do not turn off the Vscan or disconnect the power supply requiring the device to be sent
59. ightness Adjust monitor brightness Rotate to adjust brightness and press Select Test System diagnostics wizard to test the Vscan control unit and the probe About Displays system information hardware and software 5 2 Adjust brightness so that all the tones from the darkest to the lightest can be distinguished Requires a restart of the Vscan This information may be required when contacting GE service Vscan User Manual GM092207 02 Config menu Choice 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 Inthe main menu use lt B to browse through the menu items and highlight Config Bi 3 Press Select The Config menu is displayed 4 Use lt B to browse through the menu items and highlight Setup EX 5 Press Select The Setup screen is displayed Language English Date 19 JUN 2009 Date Format dd mmm yyy Time 12 30 49PM Time Format 12h AutoFreeze min 1 CROM DUMO C 6 Use to highlight the item to adjust 7 Press Select and use Y to adjust the setting 8 Press Select to confirm the adjustment NOTE For settings with multiple parameters e g date and time use lt gt to navigate between the parameters Vscan User Manual 5 3 GM092207 02 Vscan configuration 5 4 Vscan User Manual
60. igital services network so our Technical Support teams can remotely evaluate diagnose and resolve the technical issues Shorter repair time with remote diagnostics Automated Software Updates Electronic service requests Remote error log review and recovery The installation of InSite does NOT give GE unauthorized access to your computer Each connection to your system by GE requires your approval GE s technical support teams are trained on proper patient privacy requirements in the event that any should occur lt lt Prev 10 Press Configure The nsite Configuration tool window is displayed InSite ExC Configuration Tool l ej Ioj x Location Configuration Continent EUROPE County NORWAY mh Addr Line s S S Addr Line O Cty boxe Sater ce Latitude Longitude Institution x O Departmenti Building Floor Room Proxy Configuration Proxy Disable Hame Proxy Disabled Hew Edit Delete IP Addr Fort Proxy Authentication Disable Scheme MONE Proxy User Password Submit Changes Reset Form Vscan User Manual 4 11 GM092207 02 Vscan gateway software NOTE Offline activation NOTE NOTE 4 12 All entries in bold in the nsite configuration window must be filled in e Continent e Country e City e Institution e Proxy Disable unless a proxy server is provided by your institution
61. ion 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 NOTE Press Setup Mg select the Software page and press Delete to remove the software upgrade that has been installed NOTE The procedure for software update installation from a CD is similar to the procedure described above Vscan unit software update 1 Place the Vscan on the Docking station Open the display 2 Press Update available The Software page in the Setup screen is displayed showing the available software update 3 Select the Vscan device and press Install An information window is displayed Make sure to follow all the recommendations listed Vscan User Manual 4 31 GM092207 02 Vscan gateway software e Ensure that the power supply is connected to the Docking station while upgrading the software e DO NOT TURN OFF the Vscan unit while upgrading the software CAUTION Do not turn off or disconnect power during the update nN 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 e If the test failed close the display to turn off the system and contact service e lf the test passed the software update is installed This may take several minutes The
62. ions 3 10 Review and storage Reviewing acquired images 3 11 Storage of images 3 11 Recall of stored data Deletion of data To delete an examination 3 14 To delete a file 3 14 Chapter 4 Vscan gateway software Overview About the files created in Vscan 4 2 Vscan gateway software installation Computer requirements 4 4 Installation and activation of Vscan gateway software 4 5 Connection of Vscan to a computer Using Vscan gateway software Overview 4 20 Gallery screen 4 21 Setup screen 4 28 Chapter 5 Vscan configuration Config menu system setup adjustment 5 3 Chapter 6 Vscan maintenance System care and maintenance Inspection Inspecting the Vscan 6 3 Inspecting the probe 6 3 I 6 Vscan User Manual GM092207 02 Cleaning and disinfection Cleaning 6 4 Disinfection 6 5 Reinstallation of the factory software Procedure
63. irements listed above However be aware that any software running in parallel with Vscan gateway software may impact the performance of your computer In the occurrence of a slow or instable computer try to close software which are not required for clinical purpose Installation and activation of Vscan gateway software CAUTION Vscan gateway software needs to be installed and activated before it can be used Do NOT attempt to install the Vscan gateway software on computers running software controlling life supporting devices Do NOT attempt to install the Vscan gateway software on computers running software monitoring patient condition To be able to install the Vscan gateway software the current Windows user account must have Administrator rights Installation of the Vscan gateway software Vscan User Manual GM092207 02 1 Insert the Vscan gateway software CD into the computer s CD ROM drive The installation software starts automatically and a Welcome window is displayed Welcome to the InstallShield Wizard for Yscan gateway software The InstallShield Wizard will install scan gateway software on your computer To continue click ext 4 5 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 scan gateway software InstallShield Wizard C
64. l Peak Temporal Average Intensity C 8 2 Vscan User Manual GM092207 02 Acoustic Output Reporting Tables ee ee eee ee aa Se ae Peak Rarefactional Acoustic Pressure same Cranial Bone Thermal Index same Soft Tissue Thermal Index same t PD Pulse Duration same 12 dB Output Beam Dimensions same Distance from the Source to a Specified Point same Zp Depth for TIB Depth at which the relevant index is maximum 12 12 FA Zsp Zbp Break Point Depth same Zsp Za Depth for TIS Depth at which the relevant index is maximum Explanation of Footnotes d Z Zs The mechanical and thermal indices may be replaced by one of the following footnotes because of the reasons listed e a Display of this index is not required for this operating mode e b This probe is not intended for transcranial or neonatal cephalic uses e c This formulation for TIS is less than that for an alternate formulation in this mode If so the table entries are replaced by a meaning no data are provided for this operating condition since the maximum reported value is not reported for the reason listed If neither an index or a footnote Is given this means that the index is irrelevant for this transducer mode combination Vscan User Manual 8 3 GM092207 02 Appendix Operating Conditions All table entries are with the operating conditions specified at the end of the table 8 4 Vscan Us
65. mance for the selected application are also set Vscan User Manual 7 17 GM092207 02 Safety automatically and should assist in reducing the patient exposure time Changing imaging modes ALARA Training 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 Ultrasound procedures should be performed using output levels and exposure times As Low As Reasonably Achievable ALARA while acquiring clinical information During each ultrasound examination the user is expected to weigh the medical benefit of the diagnostic information that would be obtained against the risk of potential harmful effects Once an optimal image is achieved the need for increasing acoustic output or prolonging the exposure cannot be justified It is recommended that all users receive proper training in applications before performing them in a clinical setting Contact the GE sales representative for training assistance Track 3 ALARA Educational Program The user should be familiar with the document Medical Ultrasound Safety published by AIUM American Institute of Ultrasound in Medicine see page 8 8 This document is acceptable to FDA as meeting the content of
66. move covers from the Vscan Inspecting the probe CAUTION If any defects or damages are found on the probe or its cable DO NOT use the Vscan Contact GE service Before each use 1 Inspect the lens the probe housing and the cable 2 Look for damage that might allow liquid into the probe 3 Test the functionality of the probe Vscan User Manual 6 3 GM092207 02 Vscan maintenance Cleaning Cleaning and disinfection 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 CAUTION Do not spray any liquid directly onto the Vscan or the Docking N station NOTE DO NOT scratch or press on any part of the Vscan with any Sharp objects such as pencils or pens as this may result in damage of the Vscan Cleaning the probe 6 4 Remove the coupling gel by wiping the probe lens with a soft cloth Wipe the probe and cable with a soft cloth moisten in a warm soap and water solution lt 80 F 27 C Wipe the probe and cable with a soft cloth moisten in clean water lt 80 F 27 C until all soap is removed Wipe dry with a soft towel Vscan User Manual GM092207 02 Cle
67. nce and Personalization Adjust Screen Resolution Advanced Settings e Windows XP Control Panel Display Settings Advanced Direct 3D Acceleration is Turn on Direct3D Acceleration disabled Press Start and select Run Type DxDiag and press OK Select the Display tab and verify that the Direct3D Accelerator is turned on Desktop sharing or remote This type of program may influence the desktop softwares e g display of Vscan movie in Vscan NetMeeting are running gateway software Try to close this type of program when using Vscan gateway software 6 10 Vscan User Manual GM092207 02 Troubleshooting Vscan display is flashing while scanning Vscan User Manual GM092207 02 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 To help keeping the Vscan operating temperature at an optimal functional level and to ensure longer scanning time with maximum frame rate it is recommended to hold the Vscan so that there is good contact between the device and the hand 6 11 Vscan maintenance 6 12 Vscan User Manual GM092207 02 Chapter 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 s
68. ne e Lotions e Lanoline e Aloe Vera e Olive Oil e Methyl or Ethyl Parabens para hydroxybenzoic acid e Dimethylsilicone The following gels have been tested to be compatible with the Vscan ae ee ee Aquasonics 100 Parker Laboratory Inc Clear Image Sonotech Inc Other recommendations 3 4 Like most high frequency computing devices the electronic components of Vscan will generate some heat while operating normally and as intended Vscan is equipped with safety mechanisms which will automatically reduce computing speed frame rate and ultimately shut down the device before any risk of overheating occurs Vscan is verified to comply with harmonized safety standards see Conformance Standards on page I 17 under any operating condition described in this user manual see Environmental properties on page I 3 To help keeping the Vscan operating temperature at an optimal functional level and to ensure longer scanning time with maximum frame rate it is recommended to hold the Vscan so that there is good contact between the device and the hand Image display on Vscan is dependent of the ambient light avoid direct sun light on the display when scanning and reviewing images Vscan User Manual GM092207 02 CAUTION Probe orientation Scanning Do not scan on open wound The probe is provided with an orientation marking This mark is used to identify the end of the probe corresponding to the side of t
69. ng cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms 3 Vrms V1 Ae 124P IEC 61000 4 6 150 kHz to 80 MHz 80 MHz to 800 MHz d 1 2VP 800 MHz to 2 5 GHz d IIP 80 MHZ to 2 5 GHz where p is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in Conducted RF IEC 61000 4 3 3 V m 3 V m E1 metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol o NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the ultrasound unit is use
70. ng the battery before it is fully charged but the battery will then be discharged more rapidly e Itis possible to charge the battery several times each day if needed 2 16 Vscan User Manual GM092207 02 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 Vscan User Manual 2 17 GM092207 02 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 Orientation 2 18 Vscan User Manual GM092207 02 The microSD card Make sure the card is inserted in the card slot 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 ee ese The card is partially filled up The card is nearly full No card in the Vscan device or card disabled from device while mounted to computer Vscan User Manual 2 19 GM092207
71. nly the designated power accessories battery and charger Failure to do so may result in electrical shock or fire Do not place the battery near a heat source or expose it to direct flame Such exposure may lead to corrosive liquid leakage electrical shock or fire If any liquid from battery should come in contact with the eye immediately wash the eye with plenty of water and seek medical advice as soon as possible Do not immerse or expose the battery to water To reduce risk for electrical shock do not plug or unplug the AC DC adapter from mains socket with wet hands Avoid dropping or subjecting the unit including the probe the battery and accessories to severe impacts This could result in electrical shock corrosive liquid leakage and injury Vscan User Manual GM092207 02 Q WARNING Vscan User Manual GM092207 02 Warnings 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 1 5 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
72. nnected to the computer The main functionality of Vscan gateway software is e Read and display images and movies from the Vscan scanner e Playback of audio recorded on Vscan e Distance and area measurements e Append images to an E mail e Copy examinations to the computer e Service functions for connected scanner and Vscan gateway software software diagnostics software updates log function About the files created in Vscan 4 2 Files created on Vscan are stored into examination folders Each folder has a unique name consisting the Vscan serial number the exam number followed by the date and time of storage lt Serial No gt _ lt Exam No gt _ lt yyyymmdd gt T lt hhmmss gt Each file has a unique name consisting of the Vscan serial number the exam number followed by the date and time when the exam was started lt Serial No gt _ lt Exam No gt _ lt yyyymmdd gt T lt hhmmss gt The file formats are e Still frame JPEG format e Movie MPEG 4 format e Voice notation WAV format Vscan User Manual GM092207 02 CAUTION Vscan User Manual GM092207 02 Overview 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 4 3 Vscan gateway software Vscan gateway soft
73. of Mechanical Index MI values See the specific package insert for the contrast agent being used for further details A damaged probe may result in injury or increased risk of infection Inspect the probe frequently for sharp pointed or rough surface damage that could cause injury or tear protective barriers gloves and sheaths Vscan User Manual GM092207 02 Electrical Hazard Important safety considerations 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 7 Personnel and equipment safety DANGER Explosion hazard Electrical hazard N WARNING NOTE Vscan User Manual GM092207 02 The hazards listed below can seriously affect the safety of personnel and equipment during a diagnostic ultrasound examination Never operate the equipment in the presence of flammable or explosive liquids vapors or gases Malfunctions in the Vscan or sparks can electrically ignite these substances Operators should be aware of the following points to prevent such explosion hazards If flammable substances are detected in the environment do not plug in or turn on the system e If flammable sub
74. ollowing GE recommendations can be done by the user Vscan User Manual GM092207 02 Important safety considerations Important safety considerations Patient safety Patient identification A WARNING Vscan User Manual GM092207 02 This section includes considerations for the following e Patient safety e 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 Users are obligated to familiarize themselves with these safety considerations and to avoid conditions that could result in injury or damage The concerns listed in this section can seriously affect the safety of the patient undergoing a diagnostic ultrasound examination Always include proper identification with all patient data It is recommended to use voice notation to identify the patient Identification errors could result in an incorrect diagnosis If the Vscan needs to be sent for repair ensure that any patient information is erased from the microSD card or that the microSD card is removed from the Vscan before shipping In case that any patient information is still residing on the Vscan GE will contact the customer and request for urgent collection of that patient information GE will keep this patient information in a secure environment
75. ow The System ID and Activation key fields are displayed Vscan User Manual GM092207 02 Healthcare Activation If the field s below do not get automatically filled in return to the Activation Success page and re copy the key s Then go back to this window and press Paste If performing the activation with Service or if the Paste button does not work enter the key s manually Then press Next System ID ne i Activation key gt gt Next lt lt Prev 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 Your Gateway and Vscan are now activated You can now undock your Vscan and start using it Please note your Vscan Serial Number to be used in future service calls OK 8 Press OK The nsite configuration window is displayed GE Healthcare Insite Service Platform Configuration Please open the Insite Service Platform configuration dialog by pressing the Configure button below and then enter your location information under Location Configuration The fields in bold are required When completed please press Submit Changes to save the settings then close the configuration dialog before pressing Next to proceed Configure About InSite InSite is a feature that integrates your Vscan
76. probes and systems The measurement precision and overall accuracy of the measurements have been assessed by determining both the random and the systematic uncertainties and given in percent at 95 confidence level Parameter Estimated accuracy Measurement precision black and white color a Accuracy Measured value displayed value displayed value 100 System controls affecting acoustic output The operator controls that directly affect the acoustic output are discussed in the Acoustic Output Data Tables see page 8 1 These tables show the highest possible acoustic intensity for a given mode obtainable only when the maximum combination of control settings is selected Most settings result in a much lower output It is important to note the following e The duration of an ultrasound examination is as important as the acoustic output since patient exposure to output is directly related to the exposure time e Better image quality yields faster clinical results making it possible to complete the relevant ultrasound examination more rapidly Therefore any control that improves the quality of the examination can help to reduce patient exposure even though it may not directly affect acoustic output Application selection Selecting the application appropriate to a particular ultrasound examination automatically provides acoustic output limits within FDA guidelines for that application Other parameters which optimize perfor
77. r its internal CISPR 11 function Therefore its RF emissions are very low and EN55011 are not likely to cause any interference in nearby RF emission Class B The ultrasound unit is suitable for use in all CISPR 11 establishments including domestic establishments and EN55011 those directly connected to the public low voltage power supply network that supplies buildings used for domestic Harmonic emission Class A purposes IEC 61000 3 2 Voltage fluctuations flicker Complies emissions IEC 61000 3 3 Electromagnetic immunity Guidance and manufacturer s declaration electromagnetic immunity IEC 60601 Immunity test test level Electrostatic discharge ESD 6 kV contact IEC 61000 4 2 8 kV air Electrical transients 2 kV for power supply bursts lines IEC 61000 4 4 1 kV for input output lines Surge 1 kV line s to line s IEC 61000 4 5 2 kV line s to earth 7 12 Compliance level Electromagnetic environment guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Vscan User Manual GM092207 02 Important safety considerations Guidance and manufacturer s declaration electromagnetic immunity Immunity test
78. rement tools Annot annotation tool e Store GC store current image with measurement and annotation 9 Disconnect the device Figure 4 2 Gallery screen Vscan User Manual 4 21 GM092207 02 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 Contrast Control the amount of contrast Brightness Control the amount of brightness Movie controls Voice notation controls G AWD Play Pause Start stop the voice notation avid Volume slider Adjust the audio volume by dragging the slider Scroll slider Scroll through the voice notation by dragging the slider Rewind the voice notation to the beginning 4 22 Vscan User Manual GM092207 02 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 Fr Assign patient information Firstname Lastname Patient ID Birth date dd mm yyyy Exam Comment Cancel Ma 2 Enter the information and press OK The information entered is displayed in the examination list and is used in the report Measurements and annotations Annotations distance and area measurements can be done on still frame images including movie when in pause Me
79. roll Rotate to the image of interest 2 Press Store B The image is stored to the microSD card A confirmation message is briefly displayed on screen Using Vscan Movie storage 3 12 1 While scanning or during movie replay press Store B The movie is stored to the microSD card A confirmation message is briefly displayed on screen Vscan User Manual GM092207 02 NOTE Vscan User Manual GM092207 02 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 2 Press Menu In the main menu use lt gt to browse through the menu items and highlight Gallery 7 Press Select The Gallery screen is displayed In the Gallery screen use lt P to browse to the desired examination folder In the selected examination folder use V to browse to the file to open The files that can be opened are e Single frame image with or without measurements e movie e Voice notation Press Select to open the file While reviewing a file use amp Y to review the other files in the examination To return to Live scanning press and hold down Select 3 13 Using Vscan Deletion of data To delete an examination NOTE To delete a file 3 14 8 Press Menu In the main menu use lt gt to browse through the menu items and highlight Gallery j Press
80. ry level indicator 2 14 Removing inserting the battery GM BAT 2 15 Battery GM BAT specifications 2 16 The microSD card Removing inserting the microSD card 2 17 The microSD card memory indicator 2 19 The microSD card handling recommendations 2 20 First time use Installing the battery 2 21 Vscan User Manual I 5 GM092207 02 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 3 3 Probe orientation 3 5 Patient examination 3 5 Presets 3 6 Black and white imaging 3 6 Color imaging 3 7 Auto freeze 3 8 AutoCycle 3 8 Measurements Taking measurements 3 9 Voice notations Recording Voice notat
81. stances are detected after the system has been turned on do not attempt to turn off the Vscan or to unplug it e If flammable substances are detected evacuate and ventilate the area before turning off the Vscan The internal circuits of the AC DC adapter use high voltages capable of causing serious injury or death by electrical shock Any rest energy within our scanners or their components will be below 60 V DC or 2 mJ 1 1 Safety To avoid injury e Do not remove the Vscan s protective covers No user serviceable parts are inside If servicing is required contact GE service e 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 However as this system generates high frequency electrical signals the operator should be aware of the potential hazard this could cause Electrical safety Device classifications The Vscan is an internally powered device type BF The AC DC adapter is Class Il External Connection CAUTION Connection to a PC can be done when the PC is in compliance with the IEC standard EN 60950 Data processing equipment The computer connected to Vscan must be kept outside the patient environment refer to local regulation and EN 60601 1 7 8 Vscan User Manual GM092207 02
82. ting GE Service or by going to the Internet Contacting GE Service The telephone number of your local GE Service organization can be found in Global ultrasound support center phone numbers on page 1 8 Vscan User Manual GM092207 02 Vscan User Manual GM092207 02 Vscan gateway software installation The following will be required The Vscan Serial Number written on the rear label of the control unit e 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 Select Activation form and follow the instructions on screen to complete the form and retrieve your Vscan Activation key 4 After obtaining the Activation key from the Internet the Vscan needs to be configured see Configuration on page 2 22 Vscan gateway software Connection of Vscan to a computer 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 Anybody who connects additional equipment to the signal input part or signal output part of Vscan configures a medical system and is therefore responsible that the system complies
83. to start the program NOTE If the icon is not on your desktop you can typically find it by selecting Start Programs GE Vscan gateway software The Language window is displayed Vscan User Manual 4 7 GM092207 02 Vscan gateway software Application Language User Manual Language o Cancel 2 Select the desired language for the program and for the user manual and press OK The Vscan gateway software activation window is displayed GE Healthcare Activation You need to activate your device before use To simplify this process please dock your Vscan to this PC turn the device on by opening the lid and wait how until the SN is automatically detected approx 30 s If you are not able to dock your Vscan at this time you can enter the Serial Number manually in the field below PIN Serial Number where to find When both numbers above are filled in visit the Vscan activation portal http vscan gehealthcare com or click the retrieve activation key button below Retrieve activation key s Click here if NOT able to use link above Contact service 3 Dock your Vscan on the Docking station and open the display to start Vscan 4 8 Vscan User Manual GM092207 02 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
84. uld make certain that only properly trained fully qualified service personnel undertake the installation maintenance troubleshooting calibration and repair of the equipment The owner of the Vscan should ensure that only properly trained fully qualified personnel are authorized to operate the system Before authorizing anyone to operate the system it should be verified that the person has read and fully understands the operating instructions contained in this manual It is advisable to maintain a list of authorized operators Should the system fail to operate correctly or if the Vscan does not respond to the commands described in this manual the operator should contact the nearest field GE Ultrasound Service Office For information about specific requirements and regulations applicable to the use of electronic medical equipment consult the local state and federal agencies CAUTION For USA only Federal law restricts this device to use by or on the orders of a physician CAUTION This Vscan should be used in compliance with law Some jurisdictions restrict certain uses such as gender determination Notice against user modification Never modify this product including system components cables and so on User modification may cause safety hazards Vscan User Manual 7 3 GM092207 02 Safety 7 4 and degradation in system performance All modification must be done by a GE qualified person Software upgrade f
85. utput power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Essential Performance The essential performance of the Vscan is e The ability to display physiological images as input for diagnosis by trained physician e The ability to display quantified data as input for diagnosis by trained physician e The display of ultrasound indexes as aid for safe use of the Vscan Vscan User Manual 7 15 GM092207 02 Safety Acoustic output Definition of the acoustic output parameters Thermal Index Mechanical Index Ispta Tl is an estimate of the temperature increase of soft tissue or bone There are three thermal index categories e TIS Soft tissue thermal index The main Tl category Used for applications that do not image bone e TIB Bone thermal index bone located in a focal region Used for fetal application e TIC Cranial bone thermal index bone located close to the surface Used for transcranial application Reference to calculation of TI can be found in e NEMA Standards Publication UD 3 Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment Revision 2
86. vo 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 gt 1 cm Area measurement The area measurement accuracy is 10 of the measured area for areas larger than 1 cm Vscan User Manual 8 7 GM092207 02 Appendix 8 8 NOTE 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 This document ts only available in English To contact the AIUM concerning their publications American Institute of Ultrasound in Medicine Laurel Maryland 20707 590 14750 Sweitzer Lane Suite 100 Phone 301 498 4100 or 800 638 5352 Fax 301 498 4450 Vscan User Manual GM092207 02 A Auto freeze 3 8 AutoCycle 3 8 B Battery Charge 2 11 Insert 2 75 Installation 2 27 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 7 Contraindication 1 3 D
87. ware installation Computer requirements The minimum requirements for the computer are listed in the table below Minimum requirements 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 pCPU Pentium 4 2 4 GHz or Pentium M 1 6 GHz C Disk space 700 MB on system partition 200 MB on partition where program is installed Graphic DirectX 9c compatible display adapter such as e NVIDIA GeForce 6 Series or later e AMD ATI X1000 series or later or Radeon R520 or later e Intel GMA X3000 series or later Min resolution 1024x768 Installed software Windows Media Player version 10 Adobe Acrobat Reader 4 0 or higher for On line Help function Internet Explorer version 7 or higher Microsoft Outlook for sending e mail from Vscan gateway software NOTE The computer running Vscan gateway software should have an anti virus software installed 4 4 Vscan User Manual GM092207 02 NOTE CAUTION Vscan gateway software installation 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 requ
88. with the GE digital services network so our Technical Support teams can remotely evaluate diagnose and resolve the technical issues Shorter repair time with remote diagnostics Automated Software Updates Electronic service requests Remote error log review and recovery The installation of InSite does NOT give GE unauthorized access to your computer Each connection to your system by GE requires your approval GE s technical support teams are trained on proper patient privacy requirements in the event that any should occur 9 Press Configure Vscan User Manual 4 15 GM092207 02 Vscan gateway software NOTE The Insite Configuration tool window is displayed With no Internet access there is no need to configure Insite 10 Close the nsite 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 Refer to Vscan gateway software troubleshooting on page 6 10 if you experience any issues during the functionality check The Vscan gateway software is now activated and ready for use Activation of the Vscan without Vscan gateway software 4 16 If you do not have access to a computer to install Vscan gateway software or do not wish to install the software it is still possible to activate the Vscan unit by either contac
89. ymbols on page 7 22 Vscan User Manual 7 1 GM092207 02 Safety DANGER N WARNING 1 CAUTION 1 2 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 The following icons are used to indicate precautions Indicates that a specific hazard exists that given inappropriate conditions or actions will cause e Severe or fatal personal injury e Substantial property damage Indicates that a specific hazard exists that given inappropriate conditions or actions will cause e Severe or fatal personal injury e Substantial property damage Indicates that a potential hazard may exist that given inappropriate conditions or actions can cause e Minor injury e Property damage Vscan User Manual GM092207 02 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 The owner sho

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