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User Manual for BodiTrak and FSA Systems

1. User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 Operating Instructions 37 Tools Options Folders Click on the Folders tab example shown is on Windows XP to X FSA Options General Folders Hardware e Change the location of your FSA Template folder Template folder C Documents and Settings All Users Application Data Browse Change the location of your FSA Sensor array folder Sensor array folder C Documents and Settings All Users Application Datas Browse e Cha nge the location of your FSA Document folder Report folder C Documents and Settings All Users Application Data Browse e Cha nge the loc ation of you r F SA Pri nt Re port fol d er Tool folder C Documents and Settings All Users Application Data Browse r Change the location of your FSA Tools folder Document folder C Documents and SettingsJill EXMy Documents FSA Browse For full paths on Windows Vista and 7 refer to Software Installation New Tools are slated to show up in future releases of FSA Tools Options Hardware FSA Options Click on the Hardware tab to General Folders Hardware e View the sensor arrays installed on your computer as well as their array size sensing area and calibrated range Sensor Arrays Interface Modules UT1010 4372 200mmha4 Number available 1 5 UT3010 4080 100mmho4 ae e Choose the number of interface modules you will be using O None This
2. Key the final frame recorded when the Record function is disengaged any frames collected using the Scan function the final frame collected prior to disengaging the remote trigger while using FSAin Remote mode this marks the end of each set of collected frames in Remote This default setting will be made optional in a future release of the software please keep an eye on Tools Options General in future software releases or contact techsupport vista medical com for further information 3 4 5 Selected Frames Use selected frames for exporting cutting or printing frames from your FSA file The purple check mark in the status bar indicates the frame is selected To selecta frame go to your FSA Menu Bar options Edit Select Edit De select or Edit Invert Selection Refer to Menu Bar Edit Also see Key Frames Ready to read UT1010 1234 00001 March 31 2005 02 04 53 500 PM Click here to select or de select a frame User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 ae User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 3 5 Your Main Display Area Please take a few minutes to familiarize yourself with the main FSA software display area The main display area consists of the Contour Plot Surface Plot Legend Statistics Time Plot Note Area and Video Window f2 UT1010 OC File fsa FSA Ax File Edit View Action Tools Help D Pad e a e ea Client Information Tuesday March 3
3. 40 6 crm Alone on Range O 200 mmHg 6 FSA system Plug the Interface Module s LI USB cable into a second available USB port on the computer and into the interface module BodiT rak system Connect the mat to an available USB port then go to step 8 User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 7 FSAsystem only Plug the 9V Interface Power Supply into the interface module plug a FSA mat into the appropriate port on the front of the interface module Port Aor Port Aand B depending on whether the mat has one or two connectors 8 Open your FSA software select the Template you are using then go to Tools System Settings FSA system only Ifthe maticon does not indicate the serial number of the mat you will be recalibrating select the correct sensor array from the Sensor Array drop down and click OK Note that your Scan or Record functions must be disengaged before proceeding or you will get a communication error at the start of the calibration 9 Goto Tools Calibration Wizard and click Next 10 Check the Use the autocalibrator check box click Next The Calibration Wizard will begin the calibration process The software will create a verification file by default unless you deselect that option in step two of the calibration wizard This file will be open once you click Finish at the end of the calibration view your file to decide if
4. User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 Table 204 Requirements The equipment is intended for use in the electromagnetic environment specified below The customer or the user of the equipment should assure that it is used in such an environment IEC 60601 test level Conducted RF IEC 61000 4 6 Radiated RF IEC B10004 3 3 Vins 150 kHz to 80 MHz 3 Vim 80 MHz to 2 5 GHz NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the equipment including cables than the recommended separation distance calculated fram the equation applicable to the frequency of the transmitter Recommended separation distance 15 s r iP d 7h d IP 80 MHz to B00 MHz 1 T F d v P 800 MHz t 2 5 GHz Ei where P is the maximum output power rating of the transmitter in watts WV according to the transmitter manufacturer and d is ihe recommended separation distance in meters rm 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 known RF transmitting devices and equipment marked with the following symbol Co NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by a
5. including a factory cal that the user cannot delete or overwrite FSAsystems only Choose which calibration to use from Tools System Settings by clicking on the maticon deselecting the default selection Always use the newest calibration and selecting another from the available dropdown lf your mat has 2 or more calibrated ranges ie 10 and 30 PSI this is where you choose to use another range Make sure to adjust your Legend to suit when you select another calibration range You may also want to select a previous calibration if your most recent calibration yielded unsatisfactory results You can delete calibrations but not the Sensor Array file itself by selecting a calibration then clicking the trash icon above the dropdown Use that option carefully it cannot be undone New FSAmats and mats sent in for repair are calibrated before they are shipped out they have a new sensor array file These files have a cal extension If you purchase a new mat or have your mat repaired you will receive a sensor array file with your mat To install the file to your FSA4 SensorArrays folder 1 Browse to your CD drive using My Computer or Windows Explorer 2 Double click on the file FSA4 will open and a suitable RECT ANGULAR display template will appear Acopy of your sensor array file serial number cal should now reside in your default SensorArray folder lf you have not been granted the ability to copy files from an external media CD USB
6. is no Interface Module connected to the computer You need to load your SensorArray file also refer to the FAQ s section BodiT rak Systems There is no BodiT rak mat connected to your computer Left mouse click on the status bar to get detailed information about why your system is not ready Unable to read Make sure the interface module is connected and has power N A Unable to read red light indicates there is a communication error of some sort refer to the FAQ s section Recording readings from UT2010 0123 N A 00036 Aprili 2004 08 34 37 920 AM Recording readings green light indicates the Record F3 function is engaged The frame number in this example 00036 will be changing as what you are viewing live is being recorded The time will be advancing Scanning UT2010 0123 N A 00009 April 1 2004 08 25 05 542 AM scanning green light indicates the Scan F2 function is engaged The frame number in this example 0009 will not change as what you are viewing live will not be saved as is the case with Record When you disengage the scan the last image you see will become the newest frame in the example 0009 in the file The time will be advancing Clicking in the left side of the Status Bar when your system is ready to read will bring up your System Settings Dialog also available from T ools System Settings The format that the time and date display are dependent on the Regional and Language Options settings fou
7. 1 1 Safety requirements for medical electrical systems Equipment not complying with EN 60601 shall be kept outside the patient environment as defined in the standard 1 Any person who connects external equipment to signal input signal output or other connectors has formed a system and is therefore responsible for the system to comply with the requirements of EN 60601 1 1 Ifin doubt contact qualified technician or your local representative The normal distance of atleast 1 5 m from the patient or the patient support shall be provided This product conforms with the Medical Device Directive of the European Community 92 43 EEC and complies with ISO 13485 The testing has been done to the 60601 1 3rd edition standard 0413 User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 6 2 3 Medical Electrical Equipment Classification Model numbers BT 1510 BT 1526 BT 3510 BT 3520 BT 4510 BT 4526 BT 5010 BT 5510 BT 5526 BT 6510 amp BT 6526 are Classified as Class Il medical electrical ME equipment 6 2 4 IEC 60601 1 2 2007 Ed 3 0 Tables BodiTrak Systems Table 1 Requirements The equipment is intended for use in the electromagnetic environment specified below The customer o the user of the equipment should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance a The equipment uses RF energy only
8. 59 78 you may not have enough available memory to complete the task Try closing non essential running programs Different data export formats will be made available as tools Please check our website download page at Pressuremapping Software Downloads and Instructions 3 11 Statistics 3 11 1 Average units The average of the sensor values Calculated as the sum ofall the sensors values divided by the numbers of sensors The average pressure is sensitive to extreme values which may distort its representation of the typical sensor value 3 11 2 Coefficient of Variation Astatistical measure of the deviation of a variable from its mean Coefficient of Variation Y permits the comparison of the degree of variability of the sensor values from two different sensor mat readings Thatis mat readings with different average pressures CF cr g0 3 11 3 Horizontal Center cm or in The horizontal component of the center of pressure lower left corner of the mat when viewing in the default orientation in the software The units will displayin cm or in depending on your Windows location settings 3 11 4 Maximum units Maximum indicates the highest individual sensor value in the displayed frame Note that this statistic ignores the Statistics Minimum and includes all the sensor readings when calculating their value 3 11 5 Minimum units Minimum indicates the lowest individual sensor value in the displayed frame Note tha
9. Asked Questions lf you do not have a USB capable FSA interface module and do not have a DB9 serial port on your computer You will need to obtain a high speed 115 2 kbps and up USB to DB9 serial port adaptor and install the adaptor to your computer Your FSA cable or serial port extension cable would connect to the adaptor which will connect to a USB port on your computer Adaptors may come with software that will tell you what COM port your adaptor is or you will have to determine this from Windows Start Control Panel System Hardware Device Manager Be sure to select that COM port from System Settings Interface Module You can use EITHER Serial OR USB not both As of November 1st 2009 the LI3 6 FSA Serial Cable and LIS 6 Serial Extension Cable will no longer be provided with your FSA system They are available as optional accessories if required User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 1 User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 2 3 9 Installing the FSA System USB Drivers Text in brackets applies to the FSA USB Autocalibrator only Use only the ferrited USB cable supplied with your Type 5 or 5E FSA system with your Type 5 or 5E interface module see section Proper Care of the FSA interface Modules Your Interface Module USB drivers should install automatically with the FSA software install or automatically over the internet when you connect your interface module to an available USB
10. Components 10 14 15 Configuration 29 Contact Information 3 Context Menu 25 91 Contour Plot 46 91 Copy 25 38 Create Template 28 29 Creep 91 Creep Correction 66 Custom 71 Cut 25 38 D Date 40 Delete a calibration 33 34 Delete Tao 24 Deselect 25 Deselect Frame 41 Display Range Values 49 disposal 5 Document Bar 27 Documents 91 Documents folder 36 Documernt Bar 38 96 User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 Drivers 18 E H Help 3 37 Edit 25 Hide Centers 42 EN 60601 76 81 High Speed 33 34 EN 60601 1 1 76 81 Horizontal Center 58 91 EN60601 1 81 Hysteresis 91 Enviromental Specifications 90 Error Reading 72 f e ESD 19 Europe 3 IEC 60601 1 2 2004 Ed 2 1 76 81 Exclude Minimum 42 include Minimum 42 Export eee Indivduals 71 Exporting ou Industry Canada compliance statement 76 81 Exporting Data 58 Inflator 21 Exporting Graphics 57 InflatorBag 91 Exporting Images 5 7 install 8 Installation 8 F Installing 9 Intended Use 5 FAQ 72 Interface Module 14 15 16 17 19 Fast Forward 27 39 Interface Modules 19 FCC 76 81 Isolation Bag 91 Federal Communications Commission FCC statement 76 81 File 24 7 K ae Key Frame 40 91 Pinger pa Key Frames 41 Flip 42 Folders 36 Font size 42 L Frame counter 40 Frequency 34 72 Legend 49 Frequently Asked Questions 72 Legend Display 49 License Agreement 1 _ G 7 Lock Regions 42 General Tab 36 M Glove 71 Gradient 42
11. Paste Special The Paste Special window will appear 5 Select Picture Enhanced Metafile or Picture Windows Metafile and click OK The Display area and frame from your FSA software will appear in a new file in your selected external software If you click on the image you may see resizing squares around the perimeter of the image this is software dependant Click and drag on any of the corner squares to resize to suit your application Note that the EMF option if available produces better printed images HINT Clicking on the corner resizing squares if they appear will avoid changing the aspect ratio of your image User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 os User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 3 10 3 Exporting Data 1 Select your FSA frame or frames as described in Selecting Frames 2 Select Edit Copy from the FSA Menu Bar 3 Open the external program you wish to export to 4 Select Edit Paste 7 5 Your data will be pasted into the spreadsheet Frame numbers and the 5_ Average mmHg 14 11 l ae 6 Variance mmHg 254 44 date time information will be indicated along the top columns Standard deviation mmHg 15 95 statistics labels and cell numbers along the left rows 8 Coefficient of variation 113 06 Seca ae ae 9 Horizontal center crm 23 94 Ifthe Paste option is greyed out in step 4 repeat from step 1 Ifitis still greyed 10 ertical center cm
12. System Settings BodiTrak Systems To adjust the video settings for your camera 1 Goto Tools System Settings 2 Click on your camera in the hardware tree 3 Selecta different camera from the Camera drop down if you have more than one connected to your computer or 1 Change your video quality settings from the Quality drop down 2 Click OK Drag and Drop images bmp jpg joeg from within Windows Explorer My Computer your Desktop into your FSA file video window To Drag and Drop 1 Press and hold down the button on the mouse to grab the image file 2 Drag the image file cursor to the FSA video window 3 Drop the image by releasing the button There must be an FSA frame open in order to Drag and Drop an image into it you cannot drag and drop an image into an empty file Cut Copy or Paste the image in the Video Window byright clicking over the Video Window and selecting the desired option from the context menu that appears The image will be copied to the Windows clipboard and can be pasted into another FSA frame another FSA file or third party software that accepts a bitmap from the Windows clipboard an image editor a word processor etc Notes User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 s User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 The camera you select must be able to stream video that leaves out most digital and many digital video cameras the abil
13. Tables FSA SystemsS sssssssssssnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nnna 84 4 Approved Parts and Accessories ssssssnnunsnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn mnnn 89 5 DefntionmorSymMDOl S s e E EEEE 90 6 Product Environmental Specifications sssssussnsnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nnna 90 Part VII Glossary 91 Index 95 2012 Vista Medical Ltd Introduction 1 1 Introduction 1 1 Before you Begin 1 1 1 Vista Medical Ltd Software License Agreement By opening the packages containing the software and hardware you indicate your acceptance of the following Software Hardware License Agreement This is a legal agreement between you either an individual or an entity and the manufacturer of the system Vista Medical Ltd and its suppliers By opening the packages you are agreeing to be bound by the terms of this agreement If you do not agree to the terms of this agreement promptly return the system package s to the place you obtained them for a full refund GRANT OF LICENSE This License Agreement permits you to use one copy of the enclosed software program the SOFT WARE on a single computer The SOFT WARE is in use on a computer when it is loaded into permanent memory e g hard disk CD ROM or other storage device of that computer COPYRIGHT The SOFT WARE is owned by Vista Medical Ltd and its suppliers and is protected by Canadian
14. The Statistics am seeing are wrong the values on the Contour Plot are different You have a sub section of the mat selected and the Statistics display is only showing you the values for the selected area Look at your Contour plot you should see a small rectangular blue outline Left click in the Contour Plot display panel but off of the sensing area display to deselect the selected area to get the statistics for the entire mat again My readings are too high or too low when someone is seated on the mat the picture has more or less red than it did before You need to recalibrate your mat if you have a seat or a bed mat and nota lot of time try the Applied Weight calibration technique My computer crashed Windows and FSA were re installed do not have any backups and cannot find my User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 sensor array file CD How do create a new Sensor Array file You cannot create a Sensor Array file in the field Contact techsupport vista medical com and we will e mail you the factory sensor array file You will have to recalibrate your mat as the factory calibration may be out of date User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 6 2 Safety Notices BodiTrak System 6 2 1 CAN CSA C22 2 No 60601 1 2008 ANSI AAMI ES 60601 1 2005 A2 2010 and EN 60601 1 2006 A11 2011 The BT series has been tested and
15. XX frames where XX is the number of frames possible using your mat and interface module combination will appear Click Close The yellow LED blinks when in REMOTE mode 6 Disconnect the mFLEX cable serial or USB from the rear of your interface module You are ready to collect data All functions are disabled except the ability to read remotely 7 Press the trigger button on the rear of your module to start recording The green LED flashes on the interface module at the frequency set by the user Press the trigger again to stop the green LED will revert to solid 8 Repeatstep 7 until the data gathering is complete or the maximum number of frames is stored in the interface module The green LED reverts to solid and the yellow LED stops blinking when the interface module memory is full Once remote recordings have been made they are stored in the interface module s memory for up to approximately 48 hours without the module being powered 3 6 2 Remote Download 1 Reconnect the FSA cable to the interface module Remote Download Eg 2 Disconnect the battery pack and reconnect the AC power Select the date and time that the first remate reading was taken then click Download The IM should be powered by the AC adapter while downloading particularly when downloading large amounts of data 3 Select Action Remote Download from the FSAMenu bar adjust the date time if desired then click Download The LED s go off during the data d
16. average pressure value For further detail see Variance Vertical Center The vertical component of the center of pressure as measured from the origin lower left corner of the mat when viewing in the default orientation in the software User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 About FSA 37 Acceptible Values 63 Accuracy 5 Accuracy Statement 5 Add Video 55 Address 3 Always use the newest calibration 33 34 Applied Parts 5 Applied Weight Calibration 66 Assembly of Calibration Jig 64 Autocalibrator 69 91 Average 58 91 B Black box 14 15 16 17 Bladder 21 Blend Colors 46 Blend Colours 46 Blended colors 42 Blue Light 40 Bluetooth 70 BodiTrak 5 10 Py ea CofV 58 Cal file 62 72 Cal Jig 64 Calibrated ranges 71 Calibration 33 34 62 64 66 Calibration File 62 Calibration Files 62 Calibration Frequency 63 Calibration Jig 64 Calibration Range 33 34 2012 Vista Medical Ltd Calibration selection 33 34 Calibration Wizard 28 36 66 Camera 33 34 CAN CSA C22 2 601 1 M90 81 Canadian ICES 003 76 81 Care of Mat 11 19 CE 76 81 Center 58 Center of Presssure 42 Centre 58 Check Mark 41 Class A digital apparatus 76 81 Class ME equipment 78 Class Il ME equipment 78 Cleaning 12 20 Client Info 57 Client Information 57 Coefficient of Variation 58 91 Collapse Arrow 42 45 91 Collapse Expand Arrow 45 Color Bar 49 COM Pot 33 34 Comparison View 27 44
17. clicking the arrows at the top of your scale will increase decrease the top of the range by 10 units e clicking the arrows at the bottom of the scale increases decreases the bottom of the range by 1 unit colors e Clicking SHIFT while you adjust the ranges will adjust the top by increments of 1 unit and the bottom by 1 unit increments e Clicking the UP or DOWN arrows in the center of the colour bar will raise or lower the entire range in increments of 1 or by 1 with the SHIFT key engaged e Change your units by left mouse clicking on the arrow beside the units currently in use and selecting another unit Changing the units will automatically convert the displayed values there is no need to recalibrate your mat Defaultcolor Color bar 10 Color bar with bar 10 colors with20 blend colors on HINT you may want to increase the bottom end of your scale slightly as sensors reading 0 will display and the statistic Sensing Area will include all 0 values as being part of the area Also see Include Minimum Exclude Minimum User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 so User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 LJ Select either v mmHg e kilopascals kPa e millimeters of mercury mmHg u e pounds per square inch Nicm e newtons per square centimeter kg cm e kilograms per square centimeter The software automatically converts the values for you 3 5 7 The Statistics Dis
18. close In the FSA software the gradient is always expressed as units cm eg mmHg cm psi cm Turning on this option affects the Contour and Surface plots as well as the Minimum Maximum Average Variance and Standard Deviation statistics values and units The units range defaults to 50 of the pressure range in order to increase the size of the gradient arrows that appear in the Contour Plot display decrease the top of your range to suit by clicking on the down arrow at the top of the Legend color bar You may want to set your font size to medium or large If your units run off the right side of the display right click over your main display area select Show Splitters then drag the splitter on the left of your Legend display panel left to suit 14 12 14 12 1615 12 9 amp ei d LY ee eV e Pi b 1 See a tS e a e il oo a M ww wh co oO So Oo amp Le ee oo uuu M l w ee a eo oO KM N N UU aAa A Aa A O A ee eee wow NN U A A N wD U A O N g 0 0 1 2 3 4 3 2 3 S a 2 2 2 2 2 6 5 5 6 3 2 2 2 K KN NN v A a H User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 48 User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 3 5 5 The Surface Plot The Surface Plot provides a 3 dimensional view of your subject on the sensing mat You can change the orientation as follows e Left mouse click and drag at any corner to rotate the mat This will also
19. files 1 Enter a name for your template 2 Selectthe Mat s sensor array file you wish to create a template for 3 Click the gt gt button 4 Repeatsteps 2 and 3 if creating a multi mat template 5 Click OK Your new template will now be available for selection in your FSA Template directory it will appear when you go to File New or File New Tab Note that multi mat systems may require use of a second interface module 1 interface module can read up to 32 x 32 sensors 1 32x32 array or 2 16x16 arrays for example The One sensor array per interface module option is only required when you are using two interface modules and you wish to run one mat per module with arrays less than 32 x 32 sensors Note You can change the tab title by double clicking on the text on the tab and retyping Hit ENT ER or TAB when done or ESC to abort the change 3 3 5 2 Templates Your BodiT rak or FSA mat requires a template to allow the operator to display the data collected from the BodiT rak or FSA hardware The template collects hardware information from your mats sensor array files cal such as the array size and calibration units and creates a suitable template You can create and save your desired display settings as a new template You may want to do this if you have set up a particular set of display options that suit your application and you would like to use that setting consistently While you can certainly select the default t
20. for its oa internal function Therefore its RF emissions are RF emissions CISPR 11 Group 1 very low and are not likely to cause any interference in nearby electronic equipment The equipment is suitable for use in all RF emissions Class A establishments other than domestic and may be CISPR 11 used in domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings Harmonic emissions IEC Class A used for domestic purposes provided the 61000 3 2 following warning is heeded Warning This equipment system is intended for use by healthcare professionals only This equipment io interf Voltage fluctuations flicker oem May case radio inte erenge or may ue disrupt the operation of nearby equipment It ma emissions Complies ee be necessary to take mitigation measures such IEC 61000 3 3 Nae as re orienting or relocating the equipment or shielding the location User Manual for Bodi Trak and FSA Systems 1st Edition Rev 0 Table 2 Requirements The equipment is intended for use in the electromagnetic environment specified below The customer or the user of the Equipment should assure that itis used in such an environment El ti t Immunity test IEC 60601 test level Compliance level i a ic environmen Floors should be wood concrete or ceramic tile If Electrostatic discharge ESD 6 kV contact floors are covered with IEC 61000 4 2 8 kV air synthetic material the r
21. if not installed and used in accordance with the instruction manual may cause harmful interference to radio User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 e2 User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 communications Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense The end user of this product should be aware that any changes or modifications made to this equipment without the approval of Vista Medical could result in the product not meeting the Class Alimits in which case the FCC could void the user s authority to operate the equipment This device complies with Part 15 of the FCC Rules Operation is subject to the following two conditions 1 this device may not cause harmful interference and 2 this device must accept any interference received including interference that may cause undesired operation Industry Canada compliance statement This Class Adigital apparatus complies with Canadian ICES 003 Cet appareil num rique de la classe Aest conforme a la norme NMB 003 du Canada User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 IEC 60601 1 2 2007 Ed 3 0 This product has been tested and found to comply to IEC 60601 1 2 2007 Ed 3 0 for electromagnetic compatibility EMC asa Class Aproduct The tests performed and test levels are listed in the accompanying tables
22. important information regarding where FSA files are stored sensor array files cal files will be copied in to your default SensorArray directory when you double click on the file If the file is not copied in to your default SensorArray directory you may have not been granted the required rights by your network administrator IT department Please contact them to perform that task for you or have them adjust your security settings User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 Getting Started 9 Footnote Ifinstalling onto a computer that has never had FSA 4 1 XX installed before the FSM 1 installation will create C Program Files x86 F SA typical to all operating systems as the root directory by default and will create the following directories they are what is being referred to throughout this users manual as the default directories Windows XP C Documents and Settings YOUR USER NAME My Documents FSA which store your FSA files C Documents and Settings All Users Application Data Vistamedical F SA 4 1 Reports your printed report templates C Documents and Settings All Users Application Data Vistamedical F SA 4 1 SensorArrays your sensor array may be referred to as calibration files C Documents and Settings All Users Application Data Vistamedical F SA 4 1 T emplates your document templates similar to configurations in earlier FSA versions C Documents and Settings All Users Application Data Vistam
23. key on to your hard drive FSA 4 will still open and you will see a suitable display but your sensor array file will not be copied in to your SensorArray folder Please see your Computer administrator IT department to have them resolve this for you BodiTrak systems The sensor array file is stored on the mat and there can only be one you cannot select alternates from Tools System Settings Repaired BodiT rak mats come with a new sensor array file on the mat User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 Calibration e 4 3 How Often to Calibrate The re calibration schedule depends on the frequency of use and the demands for accuracy e Frequent FSA mat use requires more frequent calibrations e Re calibrate when conducting research when statistically analyzing pressure values or when numerical pressure values are critical e tis not necessary to calibrate anew FSA mat unless you are using it for research purposes Field reports indicate a once a month pressurized inflator bag calibration schedule is prudent For Seat and Bed mats use the applied weight technique routinely to maintain accurate readings between complete calibrations T his technique requires a human subject be used as the applied weight refer to Applied Weight Calibration 4 4 Acceptable Calibration Values When performing validation on calibrations When viewing the verification file to validate the calibration ensure the following criteria
24. maticon and select the correct serial number from the sensor array drop down that appears BodiT rak Sensor array files are stored on the mat you do not select them from System Settings The files created with both BodiT rak and FSA systems will have an fsa file extension example John Doe fsa Any references to an FSAfile refers to a file created with either system User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 Operating Instructions 23 3 Operating Instructions 3 1 The Main FSA Window The default FSA software window e The default FSA Seat template is open e Untitled FSA in the Title Bar top left indicates that you have not saved yet or that you do not have an existing file open BodiT rak and FSAsystems e In this example the Status Bar lower left indicates that FSA sensor array serial number UT 1010 71371 is selected and an Interface Module connected BodiT rak systems would show the serial number of the mat connected lf you selected your Bodi Trak mat from the File New Sensor array tab you will see the serial number of your Bodi Trak mat instead of Seat on the tab et Untitled FSA File Edit View Action Tools Help Client Information Seat Minimum mmHg Maximum mmHg 7 Average mmHg v Vanance mmHg Standard deviation mmHg v Coefficient of variation Horizontal center cm Ready to read UT1010 7131 User Manual for BodiTrak and FSA
25. medical electrical equipment 3 This equipment system is intended for use by healthcare professionals only This equipment system may cause radio interference or may disrupt the operation of nearby equipment It may be necessary to take mitigation measures such as Reorienting or relocating the receiving antenna Increasing the separation between the equipment and the receiver Connecting the equipment into an outlet on a circuit different from that to which the receiver is connected Consult the dealer or an experienced radio T V technician for help 4 WARNING Use of this equipment with accessories or cables other than those qualified and sold by Vista Medical may result in increased emissions or decreased immunity of this equipment and may cause the system to be non compliant with the requirements of IEC 60601 1 2 2007 Ed 3 0 5 This equipment should not be stacked or used adjacent to other equipment If stacked or adjacent use is necessary the equipment should be observed to verify normal operation in the configuration in which itis used 6 External equipment i e personal computer intended for connection to signal input signal output or other connectors shall comply with relevant EN standard e g EN 60950 for IT equipment and the EN 60601 series for Medical electrical equipment In addition all such combinations medical equipment intended to be connected to the other equipment systems shall comply with the standard EN 60601
26. of tissue trauma Location Power Seating C Power tilt Power recline O Power elevating leg rests Power seat elevator lf you do not see any pressures on screen in the assessment frames either your scan or record functions are already engaged or your FSA hardware is not hooked up correctly Cancel the Wizard and rectify whichever applies User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 32 User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 Final Frame eating Protocol Wizar Completing the FSA Seating Protocol Wizard The wizard has compiled all the required information and will now create a recording containing the pressure readings taken during the assessment The recording will be appended to your client s file client specific information will be appended to the text found under the Client Information tab After the wizard is clased you may modify the recording as needed If you would like a printed copy of this assessment check the box labeled Print the results Ifit s inconvenient to print at this time you can open your client s file and print the assessment at a later date C Print the results To complete the seating assessment click Finish Click Finish to view and then save your assessment Note that the Seating Protocol Wizard creates a sub folder of your FSA Documents folder called Clients and your seating Assessment documents will by default be stored i
27. port If settings on your computer do not allow that install them manually as follows Windows XP 1 Connect your FSA USB AB cable to an available USB port on your computer 2 Connect your FSAUSB AB cable to your FSA Interface Module or FSAUSB Autocalibrator 3 Connect your ACCHH H FSA Interface Power Supply or ACC 70 power supply if installing an FSA USB Autocalibrator to your interface module or Autocalibrator and to a power source 4 A Found New Hardware bubble will appear in the lower right corner of your screen with the message Found New Hardware USB lt gt Serial The bubble will disappear and the Windows Found New Hardware Wizard will appear Follow the on screen instructions as follows 5 Insert your FSA software CD into your CD Drive typically D Click Next 6 The Wizard will search your drives and the internet if you are connected for the most recent drivers and should find the required files on line If it does not select the CD folder D USB Drivers Win 2000 XP Vista on your FSA software CD Click Next 7 Waitwhile the Wizard installs the drivers then click Finish 8 The Found New Hardware bubble then the Found New Hardware Wizard will appear again to install the USB Serial Port driver Repeat step 6 and 7 above for the USB Serial Port driver You will see another Found New Hardware bubble indicating that your device is ready to use You can now run your FSAdevice s
28. rotate the surface plot e Hold down SHIFT and left mouse click and drag to change its vertical display angle e Hold down CTRL and click on the Legend colour bar to toggle blend colours off and on User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 Operating Instructions 49 3 5 6 The Legend Display Panel The Legend shows you the calibration units in this example mmHg 200 200 200 a 190 range in this example 200 and color bar associated with the loaded 180 180 180 file 170 e Clicking on the color bar will cycle through the available bar color 160 160 Hae sets as follows 10 colors white at bottom 20 colors white at an 7 140 bottom 10 shades of gray white at the bottom 20 shades of gray 30 white atthe bottom 10 shades of gray black at the bottom 20 120 120 shades of gray black at the bottom 10 colors blue at bottom 20 110 colors blue at bottom uo 100 e Blend Colors Hold down the CTRL key and left mouse click on the an color bar to toggle between blended and non blended colors on the F color bar as well as in the Contour and Surface plots The Blend BO 60 option will only affect the Contour plot if the display option Color 50 Blocks is selected al 40 e Adjust your Display Range Values by left mouse clicking on the T i a0 arrows atthe top bottom and center of the color bar This changes io the display only not the data already collected and saved in a file By 0 r D default TUNE mite mmHg e
29. shall comply with relevant EN standard e g EN 60950 for IT equipment and the EN 60601 series for Medical electrical equipment In addition all such combinations medical equipment intended to be connected to the other equipment systems shall comply with the standard EN 60601 1 1 Safety requirements for medical electrical systems Equipment not complying with EN 60601 shall be kept outside the patient environment as defined in the standard 1 Any person who connects external equipment to signal input signal output or other connectors has formed a system and is therefore responsible for the system to comply with the requirements of EN 60601 1 1 Ifin doubt contact qualified technician or your local representative The normal distance of atleast 1 5 m from the patient or the patient support shall be provided This product conforms with the Medical Device Directive of the European Community 92 43 EEC and complies with ISO 13485 The testing has been done to the 60601 1 3rd edition standard 0413 User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 84 User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 6 3 3 IEC 60601 1 2 2004 Ed 2 1 Tables FSA Systems Table 201 Requirements The equipment is intended for use in the electromagnetic environment specified below The customer or the user of the equipment should assure that it is used in such an environment Emissions test Compliance Electromagnetic e
30. sold by Vista Medical may result in increased emissions or decreased immunity of this equipment and may cause the system to be non compliant with the requirements of IEC 60601 1 2 2004 Ed 2 1 Tables FSA Systems for FSA systems IEC 60601 1 2 2007 Tables for BodiTrak systems For FSA systems refer to Approved Parts and Accessories Electrical interference such as electrical transients or bursts may cause the sensing mat to stop working temporarily To mitigate such occurrences try moving to another location and rescanning or avoid using near equipment with a high amount of electrical switching like motors or plugged into the same power circuit Connectors identified with the ESD warning symbol should not be touched and connections should not be made to these connectors unless ESD precautionary procedures are used We recommend that staff be trained to recognize the ESD symbol and to prevent damage by discharging themselves by touching grounded metal prior to handling the USB connector or plugging it in Refer to Definition of Symbols The equipment should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary the equipment should be observed to verify normal operation in the configuration in which it will be used No modification of this equipment is allowed See Safety Notices CAN CSA C22 2 No 60601 1 2008 ANSI AAMI ES 60601 1 2005 A2 2010 and EN 60601 1 2006 A11 2011 for BodiTrak Systems
31. to File New click the Sensor arrays tab and double click on the mat that appears this is the mat connected to your computer FSA Click the drop down arrow to the right of the New button in your FSA toolbar and select Seat from the drop down list that appears You will see a tab labeled with the serial number of your mat BodiT rak or Seat FSA with a Client Information tab behind it this is actually the default that appears when you initially install and open the FSA software 3 Click the Client Information Tab to add client specific notes such as name date of birth relevant medical history etc Click the Serial number Seat tab to return to your main display Click the Scan button in the FSA toolbar or hit F2 on your keyboard to start collecting data Click the Scan button again to stop collecting data You have created a single frame Click in the Note Area to add frame specific notes Repeat steps 5 through 7 one more time then go to step 9 Click the Save button or go to File Save to save your file Se ot gt Ole We have created an FSA file with two frames of data with associated client information and frame specific notes Notes FSA systems only The serial number of the last sensor array file used with this template or existing file will appear in the status bar If this is not the mat you are using select the correct one by clicking on the message in the status bar to bring up the System Settings window Click on the
32. 1 2009 o00 0000 00 00 0 0 0 0 2 1117 5 O200 0 0 0 4 32 17 22 22 29 21 241613 12 0 0 0 0 0 0 4 5 I D oj Minimum mmHg 0 00 Maximum mmHg 167 80 Average mmHg 30 273 Variance mmHg4 1261 45 Standard deviation mmH 35 80 Coefficient of variation 04 118 43 Horizontal center cm 21 41 Vertical center cm 22 49 inf 3132307 10 182125 24 22 12 6 17 18242727210 4 171925192014 8 13 16212322130 0 151819181713 4 1015171816 6 0 0 11141716 15100 5 10131616 1 0 0 10111513116 0 coo O b Ready to read UT 1010 7354 00027 March 31 2009 6 23 38 342 AM e Choose to show or hide display panels by left mouse clicking on the Collapse Expand Arrow appearing in the centre of the splitters between each display panel e Re size the individual display areas by left mouse clicking and dragging on the grippers dotted lines in the splitters between each panel e Re arrange your display with a right click over the panel you wish to change and selecting a different panel from the context menu that appears If you want to see the Statistics panel displayed where the Time Plot is for example right click over the Time Plot area and select Statistics note that the Time Plot panel is hidden by default e Clicking on the Collapse Expand arrow to the right of the Legend Display Panel will open the Thumbnail display allowing you to compare three additional frames to the curr
33. 19 USA CSA 22 2 No 601 UL60601 TUV EN60601 CE Mark LVD FSA1050 Battery Pack 9V Manufactured by Priority Electronics Ltd 55 Trottier Bay innipeg MB Canada R3T 3R3 FSA1055 Wireless Type 5 Battery Pack open Priority Electronics Ltd 55 Trottier Bay innipeg MB Canada R3T 3R3 FSA1056 Wireless Type 5 Battery Pack closed Priority Electronics Ltd 55 Trottier Bay Winnipeg MB Canada R3T 3R3 FSA1060 9V Battery L18 L162 6 1 8m USB Cable with ferrites ACCO18 ACC 024 Type 5 5E Wireless Kits 1 L124 Interface Module Type 5 Wireless LI26 Interface Module Ty pe 5E Wireless 1 LI141 SD1000 Bluetooth Serial Adaptor with 1 dBi stub antenna 1 L142 U D100 Bluetooth USB Adaptor with 1 dBi stub antenna 1 L13C 9 23cm Parani Cable Ty pe 5 1 FSA1056 9V Battery Pack and Battery Instructions Also includes 1 LI62 1 8m 6 USB Cable with ferrites for wired use ACC9011 Type 4 Wireless Kit 1 LI141 SD1000 Bluetooth Serial Adaptor with 1 dBi stub antenna 1 L142 U D100 Bluetooth USB Adaptor with 1 dBi stub antenna 1 LI121 12 30cm Parani Cable Ty pe 4 1 FSA1056 9V Battery Pack and Battery 1 Instructions User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 o User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 As of the writing of this manual BodiTrak systems do not have any parts or accessories only the BodiTrak mats Definition of Symbols ss ADH Caution risk of dang
34. 510 BT4526 BT5010 BT6510 BT6526____ OrtnoGait 80x580 FSAsystems FT 1005 FT 1015 FT 1020 FT 1030 FT 1035 ST 1510 ST 1526 ST 3510 UT 1009 UT 1010 UT 1021 UT 1025 UT 1026 UT 1027 UT 3010 UT 3020 UT 3030 UT 4010 UT 5010 5 UT 6010 Mat specific instructions will be included with Custom mats BT 5010 FSAST5010 and UT 5010 as required 1 1 9 Applied Parts The sensor mat itself is classified as a T ype B applied part 1 1 10 Disposal of the BodiTrak and FSA Hardware These products have been designed to be WEEE and RoHS compliant BodiT rak mats amp FSA Interface Modules contains printed circuit boards dispose of per your territory s regulations If there are any concern return to the manufacturer for disposal 1 1 11 Statement of Accuracy BodiT rak amp FSA pressure mapping sensors are accurate to within 20 over the recommended operating range For more details concerning the limits of accuracy please refer to Part IV section 4 Acceptable Calibration Values User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 6 User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 1 1 12 Warnings BodiT rak amp FSA Systems Medical Electrical Equipment ME requires special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the accompanying documents Use of this equipment with accessories or cables other than those qualified and
35. CAN CSA C22 2 601 1 M90 UL 60601 1 and EN60601 1 for FSA Systems and Electronic Emissions Notices BodiT rak Systems Only No warnings apply to BodiTrak alone see above FSA Systems Only Improper care and or use of the FSA Interface Module could possibly lead to malfunction failure or damage to the FSA Interface Module The FSA mat covering should not be put in direct contact with broken skin Improper care of and or use of FSA mat s could possibly lead to malfunction failure or damage to the FSA pressure sensing mat User Manual for Bodi Trak and FSA Systems 1st Edition Rev 0 Introduction 1 1 13 Typographical Conventions Special Bold indicates an item that must be selected such as a menu option command button or list item or a minor topic heading Italics are used to emphasize an important point Bold Italics indicate a warning CAPIT ALS indicate the names of keys on the keyboard such as INSERT CTRL KEY KEY indicate a key combination Hold down the first key continue holding it down then select the second key User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 8 User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 2 2 1 Software 2 1 1 Software Installation BodiTrak systems are run on powered by FSA 4 1 and up software From CD FSA Systems 1 Insert the FSACD into the CD ROM drive typically D on your computer Ifthe setup does not start automatically Click the Start button
36. CES 003 Cet appareil num rique de la classe A est conforme a la norme NMB 003 du Canada User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 Table of Contents Foreword 0 Part Introduction 1 1 Before YOU Begish st cee aea ae O ec olmedh teres E 1 Vista Medical Ltd Software License Agreement ccsssseesseeeeeeeeeeeeeeeensneeeeenenseeeeeseeeeeesseenanneesseneneneeseeeeeennas 1 LUNE Gi Warranty enra ct eneet ices cece a cate E Raa a E EEan EAAS RA 1 User ASSISTANCE MIormation corso aa oe ews aAa TA N Eaa EEA ERa Aa ERAAN SEELA KATE 3 SYSTEM Peguirements rsson a AEA a ae a aa aa AEA 4 Operator Regule ments zonin aA a a A 4 Operator and Patient Positioning iisss tcccseciccsas nt cccnceet ati cesceeniats leascetcennvensennebennctecel deedstannseccusbnbebueueendetaersinenbectawaees 5 iMtended USE asec eee ew ata a AA ASE AE sunita saaabeaceuuetcanuask 5 Models Covered by This User Manual icscsciiicccccscesccsseesscsencdscececscsdincvecsaueneencteedeedendtieenscittnasawnneenseesdasstaueasensenes 5 Apphed Pants sa a A a aaa aa aa ant at tee da 5 Dis posal of the BodiTrak and FSA Hardware cssesssscssesssesnseeneeneesenesnesenneeneeeneeeneneneeseneeeeeeeseeneeeeeeeeeeeneeees 5 Slate MENM Ol ACCURACY nre EE E a E EAE 5 Wathihngs sereine ain A eaa EE aE a EEE 6 Typographical COMVS MUO INS nanen a en aE aa aaa aa cats ua aeeceeenee 7 Part Il Getting Started 8 Ae PS OMW ANG srpnu a E e E EE EA E E a 8 Sotware
37. Coefficient of Variation Acceptance Limit The coefficient of variation must be less than 10 Verification levels Assessment is made at the 50 level and one step below and one step above for both increase and decrease in pressure Range of Readings Acceptance Limit Ata specific pressure level each sensor must not read higher or lower than an amount that is 10 of the maximum pressure Verification Levels Assessment is made at the 50 level and one step below and one step above for both increase and decrease in pressure User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 64 User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 4 5 Calibration Instructions 4 5 1 Assembly of the Calibration Jig 1 Find 2 fingers and 6 slots typical 2 Place 1 finger into 6 slots Slide the finger to the ends of the 6 slots Turn the finger 90 to interdigitate with the Slots as shown below 3 Place the second finger into the same 6 slots Slide the second finger to the opposite ends of the same 6 slots Turn the finger 90 to interdigitate with the slots 4 Repeat steps 1 3 until all the slots supplied are supported by fingers _ Example pre April 2007 small calibration jig fet ea 5 matand inflator layered between them as described in Placement of the Sensing Maton the page to follow Sit finger notched side up on work surface Slide notched slot into matching notch on jig finger Repeat on
38. Create Template recommended or install as follows 1 Browse to your CD drive OR default Sensor Array directory using My Computer or Windows Explorer the default directories are shown under T ools Options Folders Double click on the Sensor Array UT HH cal file 2 FSA4will open and a suitable RECTANGULAR display template will appear 3 Goto File Save as Template 4 Name the new Template something suitable to differentiate it from other T emplates in your directory I am unable to scan see my mat serial number in the status bar but when I hit Scan or Record get an Error reading message You have a communication error which could be due to a number of factors e lf you have not already tried rebooting your computer please do so T ry scanning again T hat may resolve the problem e lf you started your FSA software up before connecting the hardware the software is unable to autodetect the COM port your hardware is connected to Try shutting down your FSA software and restarting it If your computer is unable to autodetect your interface module make sure the Detect hardware at startup option is selected under T ools Options General itis selected by default If that option was deselected select it click OK shut down and re start your FSA software Try scanning again e lf you have upgraded from 4 0 208 or prior to 4 0 209 and up you may have to manually enter your COM number under Tools System Settings Interfa
39. FSA oe File Open Opens an existing FSA file the default Documents directory will open Select left mouse Click the file you wish to open then OK or use CTRL O also see the FSA Document Send Bar 1 Anderson L Seat Psa 2 Smith B Seat fsa File Save Saves any changes made to your file since the last save If saving for the first time 3 Watt M Seat fsa the Save As window will open in the default Documents directory prompting you to name the 4 Wiliams B Bed fsa file T ype a name in the File name window then Save or use CT RL S also see the FSA 5 Hall Seat Psa Document Bar 6 Cho Seat fsa Exit File Save As Saves an existing FSAfile under a new name also see File Save File Save As Template Saves the current document as a Template in the Templates folder File New Tab formerly Add Recording Adds a new recording tab to your currently opened FSA file The New Tab User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 Operating Instructions 25 window will open Select the kind of recording you will be adding to your file mat type Seat for example plus Source Template combination you wish to use and click OK Also see Templates Note You can change the tab title by double clicking on the text on the tab and retyping Hit ENTER or TAB when done or ESC to abort the change File Delete Tab Deletes the currently selected recording tab from your currently opened FSA file File Print Opens th
40. Installato srani aaa a a NE 8 Upgrading or Re installing the Software ssssssssnnnnnnnennnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nnmnnn nnmnnn nnmnnn nnna 9 2 B dilrak SVE MS anai ah a a a a a neoa te 10 Component Description of BodiTrak System sssssssnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nnmnnn nnmnnn nnna 10 Hardware Setup for BodiTrak System a sssssssssssnunnnnnnnnennnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nnmnnn nnmnnn nnmnnn nnmnnn nnna 11 Proper Care of th BodiTrak Mal iciscsetctccc co ceccadiccchassscicetetbccendevacutonstesstencuevtessesiciseeetentsaedeeedearttstasvenstenneeiees 11 Cleaning the BodiTrak Mat i iii sariini aaa aand aaa daa aa a aaraa aaa ae a adaa AAE AOAR AARAA 12 DO FSA Systems noari E 13 Component Description of FSA Type 4 System ssssssssnssnsnnnnsnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nenna nnna 14 Component Description of FSA Type 5 or 5E System ssssssssssssssnnnnnnnnennnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nnmnnn nnna 15 Hardware Setup USB FSA System S oaa O a aa A A aE aa N A aAa 16 Hardware Setup Serial FSA Syste MS arisia aap aaa aan aada a arai araisa apia 17 installing the FSA Syst m USB Drivers a a ea ee eee 18 Proper Cale Or the FSA Maliante AEE a E a 19 Proper Care of the FSA Interiace Modules isisi aaa a aaa aaa A a N aaan 19 Cleanmg the FSA Mat iirc aa a aa aeara 20 Calibration EQUIDMENL sisseer iina a a EEA KA EET EA AAEE 21 5 S
41. MHz 800 MHzto 2 5 GHz of transmitter 6 3 Safety Notices FSA System 6 3 1 CAN CSA C22 2 601 1 M90 UL 60601 1 and EN60601 1 The FSA system products have been tested and found to comply with CAN CSA C22 2 601 1 M90 UL 60601 1 and EN60601 1 The following information is provided for clarification e Medical Device T ype Class with measurement function e Degree of protection against electric shock T ype B Applied Part e Degree of protection against ingress of water IPX0 e Degree of safety of application in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide Equipment not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide e Mode of operation Continuous e Environmental Operating Conditions 10 40 C 30 75 rH non condensing 700 1060hPa 6 3 2 Electronic Emissions Notices FSA Systems Federal Communications Commission FCC statement The Federal Communications Commission in 47 CFR 15 105 has specified that the following notice be brought to the attention of the users of this product This equipment has been tested and found to comply with the limits for a Class Adigital device pursuant to Part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment This equipment generates uses and can radiate radio frequency energy and
42. Main Display 42 Gray light 40 Main Window 23 Green light 40 Mamimum 58 Gripper 45 91 Map 10 14 15 Grippers 42 Mat 10 14 15 Mat Icon 33 34 Maximum 91 2012 Vista Medical Ltd Menu Bar 24 Minimum 58 91 Model 5 10 13 Models 5 10 13 Module 16 17 Multiple calibrated ranges 71 _N Navigation Bar 2 7 39 New 24 38 New Tab 24 Normal View 2 7 Not Ready 40 72 Not Ready to Read 40 Note Area 51 O Open 24 38 Operator Positioning 5 Operator Requirements 4 Options 28 P Pad 14 15 Paste 25 38 Patient Positioning 5 Platen 21 Platens 64 Play 27 39 Play button 39 Pot 33 34 Print 24 38 56 Print Prevew 24 Printing 56 R Ready to Read 40 Recent File List 24 Record 2 7 38 91 Recording 91 Red light 40 Regional Distribution 59 91 Reinstalling 9 2012 Vista Medical Ltd Remote 53 54 91 Remote Download 27 53 54 Remote Frequency 33 34 Remote FSA 53 Remote Setup 27 53 Reports 56 Reports folder 36 Rewind 27 39 RoHS 5 2 Sample session 22 Save 24 38 Save As 24 38 Scan 27 38 91 Scan Frequency 33 34 Scanrate 34 Scan speed 34 Scroll Bar 52 Seating Protocol Wizard 28 31 Select 25 41 Select a sensor array 33 34 Select Calibration 33 34 Select Frame 41 Selectable Areas 60 91 Selected Frame 40 91 Selected Frames 41 Sensing Area 61 91 Sensor Array 33 34 91 Sensor Array file 62 72 Sensor Array folder 36 SensorArray file 62 Seria
43. Systems 1st Edition Rev 0 24 User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 3 2 The Title Bar The title bar located at the top of your FSAwindow indicates the name of the FSA file that is open When launching the FSA software the program opens to a new file by default It will remain Untitled FSA until itis saved and given a file name of your choosing The three icons on the far right of the title bar are Windows commands which allow you to minimize maximize and close from left to right the FSA file you are working with Untitled FSA mmx Title Bar Left Side Title Bar Right Side 3 3 The Menu Bar File Edit View Action Tools Help Left mouse click on a heading then scroll down the menu that appears Left click to select your task 3 3 1 File ave File New Starts a new file the New window will open Select the kind of recording you will be gt Open ctr a creating from the Templates tab or click the Sensor arrays tab and select the specific mat you will be using by double clicking on it or single click then OK or use CT RL N also see the Severe FSA Document Bar ABodiT rak mat s sensor array file is loaded when the mat is connected Save 4s Template to the com puter New Tab TIP You can also create a new FSA document from the Windows Explorer context menu Right Delete Tab click over your desktop or inside a folder and select New FSA Document Double click on Tr as the file to open
44. The user operator or installer of this equipment is advised of the following 1 In a domestic environment this product may cause radio interference in which case the user may be required to take adequate corrective measures 2 Portable and mobile RF communications can affect medical electrical equipment 3 This equipment system is intended for use by healthcare professionals only This equipment system may cause radio interference or may disrupt the operation of nearby equipment It may be necessary to take mitigation measures such as Reorienting or relocating the receiving antenna Increasing the separation between the equipment and the receiver Connecting the equipment into an outlet on a circuit different from that to which the receiver is connected Consult the dealer or an experienced radio T V technician for help 4 WARNING Use of this equipment with accessories or cables other than those qualified and sold by Vista Medical may result in increased emissions or decreased immunity of this equipment and may cause the system to be non compliant with the requirements of IEC 60601 1 2 2007 Ed 3 0 5 This equipment should not be stacked or used adjacent to other equipment If stacked or adjacent use is necessary the equipment should be observed to verify normal operation in the configuration in which itis used 6 External equipment i e personal computer intended for connection to signal input signal output or other connectors
45. User Manual for BodiTrak and FSA Systems 1st Editon Rev 0 Copyright October 2012 User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 2012 Vista Medical Ltd All rights reserved No parts of this work may be reproduced in any form or by any means graphic electronic or mechanical including photocopying recording taping or information storage and retrieval systems without the written permission of the publisher Products that are referred to in this document may be either trademarks and or registered trademarks of the respective owners The publisher and the author make no claim to these trademarks While every precaution has been taken in the preparation of this document the publisher and the author assume no responsibility for errors or omissions or for damages resulting from the use of information contained in this document or from the use of programs and source code that may accompanyit In no event shall the publisher and the author be liable for any loss of profit or any other commercial damage caused or alleged to have been caused directly or indirectly by this document Printed October 2012 in Winnipeg Manitoba Canada Publisher Vista Medical Ltd Managing Editor Carol Vermeer Technical Editors Carol Vermeer Grant Derksen Ted Duthoit Cover Designer Carol Vermeer Team Coordinator Carol Vermeer Production Vista Medical Ltd Federal Communications Commission FCC s
46. aaa aE aaa E 45 SPIES pirori aa ora a Saa a a 45 The Contour Plotare a a a E 46 The Surface PIOI cicsiarirr dna a aaa ea Ea ea ADi a a a eA aa Ea EEA 48 TheLegend Display Panel sro naea a a a a aaao 49 The Statistics Display Pahe rsisi a aaa araa aaa aa 50 Th TERT OPIOIDS DAY ioa a a a a a aaa 50 The NOTE FANG aooiee aea aE eaa a a a a a ease 51 The video WIN GOW eraa naana a aea a O eE A EEAO A 51 HRl Eele el M Ban scevzscvecetececeszteceseeectdcereiceacsaeeeeadeeigetendyieveictaegeticasveiesadsideinets E 52 6 Remote FSA Type 4 Systems Only nannnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn ennn nnnm 53 Remote Se TUN 0 iss cae E IE AES NEAS shu S AA EE E AE 53 Remote DOwMmMoad ssrin a E a E aA Ea 54 POGING VideO ciran Aa aA ESAERA 55 Printing Reports oaa a Ea EE E a a EEE E ES EAEEREN EENES 56 9 Aine Ghent information TaD pri a a aa 57 TO SEX PONG Cian A a 57 What can be exported from the Software s sssssssnsensennnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nn nnnnnnnnnnnnnn nnmnnn nnmnnn nnn nnmnnn 57 Exporting a Grape eiscisetecccsvccvcsdeicscenctaccaccccee vatenassavencenssteadent dad deecesauxdansuantentvacsceadaadacusabenusevetveedsasSusdeentenastecedeevess 57 EXDOFUING Dala a eat es a a uci aie cd raa a Aara aE a aa A aar aaa s a O aaa 58 As SSUAUISUGS nenn a 58 Average UNIS oaii a a ae a a ai 58 Coeficient OF Variation 76 sae dhe a ea 58 Horizontal CENTER CI ONTI Jesue aaae ae ieee accel deter
47. able 1 6 2m USB A B cable LI62 which connects the interface module to the computer via USB port Interface Universal Power Supply 9V DC ACC2021 Power Cord Set 8 2 5m or 10 3m ACCXXXX depending on your countries requirements Battery Pack with 9 volt battery FSA1050 FSA Software CD including an electronic user s manual plus FSA sensor array file CD if two or more mats purchased Hard copy Manuals are only included if required by your jurisdiction Isolation Bags 10 clear polyethylene plastic bags typical 3 Bed Isolation bags are intended for single use only dispose of them according to your institution s biological waste disposal guidelines Also see Approved Parts and Accessories Contents of the Calibration Jig Box Bodi Trak or FSA User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 Getting Started 15 2 3 2 Component Description of FSA Type 5 or 5E System Shipping Tube with Shipping Foam your typical Type 5 or 5E FSA system will arrive with the sensing mat wrapped around the foam core and the interface module and other accessories inside the foam Note that for the Type 5 Interface Module the mat cable leads into the foam core and is attached to your interface module Type 5E systems do not have the mat permanently attached to the module Save the tube and foam for storage or transportation of your FSA system Typical FSA Mats are covered in a polyurethane coated ripstop nylon or Nylon L
48. able in frame 3 and the instructions once calibration is in process Use the applied weight technique routinely to maintain accurate readings between complete calibrations for seat and bed mats User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 Calibration Pressurized inflator bag calibration Standard Options screen FSA Calibration Wizard Standard Options EA Please enter the details of how you would like to calibrate Enter the requested information then click Next Calibration range l to 200 mmHg fa e Enter your calibration range and units e Select Use the autocalibrator if you have one e Click Next C Use the autocalibrator More Options Choices available by selecting More Options FSA Calibration Wizard X i r i za we Change the default calibration settings here if you desire ptions Please enter the details of how you would like to calibrate EA It IS recom m ended you leave as IS Enter the requested information then click Next Cl ick Next Calibration range 0 to 200 mmHg x Leaving the conductance unknown option selected allows Conductance Z Unknown the software to determine the conductance of the mat fb R automatically Creep time 60 The Creep time is in seconds and defaults to 60 If you are concerned about Creep increase the Creep Time For best accuracy use the average of the time at which the real data will be taken Create a v
49. accompanying written materials and any accompanying HARDWARE This limited warranty gives you specific legal rights You may have others which vary from State jurisdiction to state jurisdiction NO LIABILITY FOR CONSEQUENTIAL DAMAGES To the maximum extent permitted by applicable law in no event shall Vista Medical Ltd or its suppliers be liable for any damages whatsoever including without limitation damages for loss of business profits business interruption loss of business information or any other pecuniary loss arising out of the use of or inability to use this product even if Vista Medical Ltd has been advised of the possibility of such damages Because some states jurisdictions do not allow the exclusion or limitation of liability for consequential or incidental damages the above limitation may not apply to you THIS AGREEMENT IS GOVERNED BY THE LAWS IN THE PROVINCE OF MANITOBA should you have any questions concerning this Agreement or if you desire to contact Vista Medical Ltd for any reason please refer to the address and telephone numbers provided in the documentation for your system Information in this document is subject to change without notice No part of this document may be reproduced or transmitted in any form or by any means electronic or mechanical for any purpose without the express written permission of Vista Medical Ltd User Manual for BodiT rak and FSA Systems 1st Edition Rev0 2012 Vista Medical Lt
50. ace Module is connected to the computer through e select or deselect High Speed mode e Upload Firmware when required see Upload Firmware Clicking on the mat icon will allow the operator to e select the sensor array to use e select or deselect the option to Always use newest calibration e select the calibration range to use for multiple calibration range mats deselect Always use the newest calibration to enable the option Bidelete the selected calibration You cannot delete the factory sensor array file s calibration The Time and Range details for the currently selected file will appear below the calibration range drop down 34 User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 3 3 5 5 System Settings BodiTrak Systems System Settings Scan rate Video Oi As fast as possible Use camera if available Frequency Hz Camera gt Period seconds Quality Sensor anaye Serial Humber OT5010 7197 Description Status T6x16 45 5 45 5 cm 0 200 mmHg Cancel Also see Adding Video 3 3 5 6 Scan Rate The Scan Rate options for BodiT rak mats serial numbers starting with BT e The actual speed for the option As fast as possible is dependent on your mat type and computer Less sensors higher speed e The program defaults to scan by Frequency at 5 HZ adjust as desired 1 reading per second 1Hz e Choose Period to scan in seconds adjust as desi
51. al Ltd
52. ame All All frames in currently displayed FSA file Forward All frames from the currently displayed FSA frame forwards Backward All frames from the currently displayed FSA frame backwards File Edit View Action Tools Help i fe p cut Ctrl Client Cerle Copy Select gt ACheck mark will appear in the status bar to indicate the frame is selected i i i i or disappear if de selected Invert Selection Current Ins All Eritrea ee o L 1o o Foward C 01225 March 24 2005 11 44 33 563 AM Rackward krl FSA software offers full Windows Cut and Paste to the clipboard capability You will be able to Cut Copy and Paste text into and from the Client Information page and or in the Note Area as indicated by the toolbar icons This means you can paste existing text txt forms or questionnaires into these areas to make them a permanent part of that patient file These areas can be updated at any time Highlight left click and drag your cursor then release the text in your document or file with your left mouse button then select the desired action from the menu bar tool bar or context menu selecting Cut or Copy while a Recording tab is selected and a file open allows you to copy or move cut a frame or frames of your FSA file and insert paste the copied frame or frames from FSA file to FSA file or onto another recording tab export the graphs or data into another software program that supports the forma
53. ample SESSO irer ia E a EA EAR END 22 Part Ill Operating Instructions 23 1 PINGS Mam FSA WANG OW sacie eer nE E EEE ness tinea beaues AEE EEN 23 2 NS CNEB e a eee eee a oe eee eR 24 3 URE Menu Bal e a a 24 RIE n E rere 24 Edi ebrian aaa a OOA E a al EE e sd aA EAER 25 VEW a a E ene ee ee eee oe eae 27 2012 Vista Medical Ltd Contents l POCUON anene aa habs EE cee veumeubeuedeaeeras duces 27 MOONS ape ect cesses ees ta as eet cae eect sn ecco E 28 Greate E E te ses ssc E acute cic E E E EE E 29 TEPA lOS oaa E E AO 29 Seating FrorocolWiza derse e EE E E E a A a OE 31 SYSTEM SEHINGS FSA SyS TEME sina n A a a wraNcuine ad ausedsateac ace maeee 33 System Settings Bodilrak Systemsa aa aerae EEr EA EEEE EEE E AET 34 A O a E E eee ene 34 Upload Firw are lt FSA Sy Steins reire iee e aE Ea r a E a a aE Rd 35 Calibr alion AMZA xin ar E a e E A aoe 36 OPIONS O E E E hep seavaneeuneoreseanceirmass 36 Help Nean a E E A Aa E 37 A DE OO BATS eara EEA 38 THe DOCUMENT Bar psor aae a 38 THE Navigation Bar a r a ae ccs canecice cine aa a aa Aa AE AAA E AE aaa aaa AEA P ANa aS a ESEA aa aAa EA Aea ACAENA aan 39 THE StatUS Bar cen a i 40 Key Frames sosoo rrea a a e a a e E A E E aA A A ae aaea Ea a Ea EAE aaa AE 41 Selected FRAIN GS cpn EA E 41 5 Your Main DISDIBY Area eannan heen ianen ana e a aa aE E a aaa AEA EEan EAA EEEa 42 COMPAS ON VIEW niiina esea a a 44 TRUM ONAN DIS LAY iara eaaa ie aiaa a a a a A a
54. an not be recorded or stored once the power supply has been disconnected from the interface module Do not have battery and wall power connected to the module at the same time damage to the components may result Type 5 and 5E Interface Modules do not support the Remote feature FSA type 4 interface modules are available with an extra 4 MB of memory which increases the number of frames the module is able to store Please contact your distributor if you require further information 3 6 1 Remote Setup Remember to switch to battery power before setting up the remote session 1 Plug the battery pack into the PWR port on the rear of your FSA Interface Module Solid green LED indicates the module is powered 2 Goto Tools System Settings to set your remote frequency Click OK 3 Goto Action Remote Setup in the FSAmenu bar 4 Adialog box will appear asking you to select your scan rate Your choices are User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 54 User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 e Frequency in frames per second Remote Setup Eg e Period in seconds per frame Enter how quickly the interface madule should take readings e Maximum scan speed the default Make your selection and click OK C Frequency Period Maximum scan speed 5 When setup is complete the message The interface module has been setup to take remote readings It is capable of recording up to
55. and choose Run from the drop down menu that appears or hit the Windows R keys together Type D setup in the dialog box that appears Left mouse click on OK 2 Follow the instructions in the installation wizard From USB Flash Drive BodiT rak Systems 1 Insert the Flash Drive into an available USB port on your computer wait to hear the Windows Device Connect tone then Windows Vista or Windows 7 When the AutoPlay window appears select the Browse option or Windows XP or Windows Vista or 7 ifthe AutoPlay window does not appear Click the Start button and go to My Computer or Computer browse to your USB Drive 2 Look for the Setup file and double click to start the install 3 Follow the instructions in the installation wizard From Internet Download 1 Download the file FSAsetup v4_1_ exe to your desktop suggested 2 When the download is complete double click the file FSAsetup v4_1_ exe and following the on screen instructions indicates the release version Installation onto the Windows Vista or Windows 7 operating systems A warning may appear indicating an unidentified or unknown program wants to access or make changes to your computer Click Allow Vista or Yes Windows 7 to install the FSA software FSA4 1 can be run by restricted users but may have to be installed by someone with administrative rights depending on how your users rights are set up by your IT department Please read footnote for
56. arrow visible between your Legend and Scroll Bar panels The Thumbnail Display operates similarly to the Comparison view click on any of the thumbnails on the right and scroll through using your scroll bar or mouse wheel to select and compare consecutive frames in your currently selected file The thumbnail currently selected appears in the large window 3 9 3 Splitters Griopert CollapseExpand arrow Splitters are the visual dividing lines between each display panel and are hidden by default To show splitters right click anywhere over your main display area and select Show Splitters from the context menu that appears Conversely if you wish to hide them right click to pull up the context menu and select Hide Splitters User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 a User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 3 5 4 The Contour Plot Example of the Contour Plot Seat template Example of the Contour Plot a frame from a selected with no data collected seating evaluation file The Contour Plot is a 2D colour display of your sensing array data It also shows your numerical pressure values if that option is selected By default the data collected during your pressure mapping session will include the entire array which includes 0 values as indicated in the example above Likewise the Sensing Area cm statistic will include the entire array You may want to change the bottom of the s
57. ate as well but you will want to remove the data from the file refer to Menu Bar Edit and Save As NOT Save into the Templates directory As of FSA software 4 0 213 any custom Template you create will be available as a template for a new recording and selectable under File New or File New Tab Also see ools Create Template User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 Operating Instructions 31 3 3 5 3 Seating Protocol Wizard The Seating Protocol Wizard tool precisely steps you through a seating assessment just follow the instructions in each frame entering required desired information as you go Make sure your FSA hardware is hooked up to your computer ready to go and the Scan or Record functions disengaged before starting the Seating Protocol Wizard Frames 1 and ee Se Be _ lx Welcome to the FSA Seating Protocol Wizard Seating Protoc p Seating Protocol Wizard i Please enter information about the client Activity Level Client Active fulltime wheelchair rider smith Jane C Passive fulltime wheelchair rider C Power chair rider Risk Factors Current Equipment BW Seer ger C Incontinent Chair type and model Smokes Poor nutrition Hours sitting in wheelchair scooter 0 C Sliding in bed Fart Time Wheelchair Scooter Riders Cushion type Hours outside of wheelchascooter 0 O sliding in chair _ Advanced aging Postural supports History
58. ation Bags 10 clear polyethylene plastic bags typical 3 Bed Isolation bags are intended for single use only dispose of them according to your institution s biological waste disposal guidelines You should only use the ferrited USB cable supplied wth your FSA system with a Type 5 or 5E Interface Module Also see Approved Parts and Accessories Contents of the Calibration Jig Box Bodi Trak or FSA User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 16 User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 2 3 3 Hardware Setup USB FSA Systems Connecting the Computer Interface Module and Mat Via USB Type 4 Type 5 Type 5E modules Use only the ferrited USB cable supplied with your Type 5 or 5E FSA system with your Type 5 or 5E interface module see section Proper Care of the FSA Interface Modules LIS USB Cable Rear view of Type 4 FSA Interface Module Frame using Type d intertace Mace 1 Type 4 Type 5 Type 5E locate the FSAUSB Cable the FSA software CD Interface Module and North American or Universal Power Supply ACC The power supply is not required with a Type 5 or 5E Interface Module 2 Type4 Typed Type 5E plug the FSAUSB cable s USB A the rectangular end securely into an available USB port on your computer 3 Type 4 Module only plug the Interface Power Supply ACC into the back of the interface module 4 Type4 Type 5 Type 5E plug the FSAUSB cable s USB B the sq
59. 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 Ifthe measured field strength in the location in which the equipment is used exceeds the applicable RF compliance level above the equipment should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the equipment b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 Table 6 Requirements Recommended separation distances between portable and mobile RF communications equipment and the BodiT rak system The BodiT rak system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the BodiT rak system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the BodiT rak system as recommended below according to the maximum output power of the communications equipment Rated Separation distance according to frequency of transmitter maximum M output power 150 kHzto 80 MHz 80 MHzto 800
60. bsorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio callular 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 equipment is used exceeds the applicable RF compliance level above the equipment should be observed to verify normal operation lf abnormal performance is observed additional measures may be necessary such as r orlenting or relocating the equipment b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 1 Vim User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 Table 206 Requirements Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT The EQUIPMENT is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the EQUIPMENT can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the EQUIPMENT as recommended below according to the maximum output power of the communications equipment separation distance ac
61. cale to 1 instead of the default 0 to remove the values up to 1 from displaying in your graph and being included in your data in above example the default of 0 is selected see all the 0 s Also see The Legend Display Panel Run your mouse without clicking over the Contour Plot with an FSAfile open A tag will appear 1 217 10 6 mmHg indicating what cell you are over with the pressure value ofthat cell to 1 decimal place Show Contours Show Color Blocks Blend Colors 28 20 27 25 14 6 22 25 AM 22 26 27 22 13 25 29 23 27 24 26 20 show Contours option show Color Blocks option Blend Colors option User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 Operating Instructions 47 Above are examples of the same frame with the display options changed Image 1 Show Contours and image 2 Show Color Blocks via the Contour plot s context menu and option 3 Blend Colours via the Legend Display panel The actual numerical data is not affected Note that Blend Colours only affects the Contour Plot when the Show Colour Blocks display option is selected Gradient The option to display Gradients instead of Normal values is available from the Contour Plot context menu Gradient is an expression of the change in readings from one sensor to the next it shows how close the high pressures are to the low pressures Fluids tend to flow from high pressure areas to low pressure areas especially if they are
62. ce Module 1 Ifyou are running via Serial port itis likely COM 1 or 2 Go to Step 3 2 Ifyou are running via USB Adaptor or FSA USB Interface Module with the device connected go to Start Control Panel System Device Manager you may have to contact someone with sufficient admin rights and look for USB Serial Port COM under Ports COM amp LPT Note the COM indicated 3 Goto FSA Tools System Settings Interface Module Enter the COM number in the Port drop down with no space between COM and the number 4 Click OK e Make sure your FSAserial cable OR FSAUSB cable is securely connected to your interface module and your computer e Your interface module may not be powered up or may not be getting sufficient power Make sure the interface power supply is connected to your module and a power source or try changing batteries if running on battery power e f connected using your FSA USB cable try another available USB port on your computer in the following manner User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 e Shut down the FSA software e Disconnect the USB cable from the computer you should hear a Windows device disconnect bleep e Reconnect the cable to another available USB port wait for the Windows device connect bleep e Restart your FSA software try scanning again If you see a Found new Hardware bubble you may have to re install your FSA USB drivers Refer to the section Installing the FSA USB Driv
63. check the time stamp of your frames in the status bar of your FSA window It likely is that the frames do not cover a 10 second interval or are more than 10 seconds apart The Time Plot field is collapsed by default when you install FSA To open it right click over your main window and select Show Splitters then click on the Collapse Expand arrow below the Contour Plot 3 5 9 The Note Area Upon stopping a scan a cursor will appear in the Note area at the bottom of your FSA4 window and text can be typed This text is always associated with the frame in view Text cannot be typed until the first frame has been recorded the Note Area will be greyed out It is recommended that the conditions and variables of the frame be described for reference for example the type of cushion positioning etc To edit the text in the Note Area 1 Left mouse click and drag over the text you wish to remove to highlight it 2 Rightclick and select Cut from the context menu that appears or Edit Cut in the FSA Menu Bar The cut text will be removed from the Note Area and placed on the Windows clipboard The cut text can be pasted into another FSA frame or into another software program Your frame needs to be static when you add information to your note area notes added when the system Is live scanning or recording are not saved 3 5 10 The Video Window If the option Use Camera is selected from Tools System Settings the video will appear in t
64. copyright laws and international treaty provisions You must treat the SOFT WARE like any other copyright material e g a book or musical recording except that you may either a make one copy of the SOFT WARE solely for backup or archival purposes or b transfer the SOFT WARE to a single hard disk provided you keep the original solely for backup or archival purposes You may not copy the written materials accompanying the SOFT WARE OTHER RESTRICTIONS You may not rent or lease the SOFT WARE but you may transfer the SOFTWARE and accompanying written materials on a permanent basis provided you retain copies and the recipient agrees to the terms of this Agreement You may not reverse engineer decompile or disassemble the SOFT WARE or HARDWARE Ifthe SOFT WARE is an update or has been updated any transfer must include the most recent update and all prior versions 5 8 96 1 1 2 Limited Warranty LIMITED WARRANTY Vista Medical Ltd warrants that a the SOFTWARE will perform substantially in accordance with the accompanying written materials for a period of ninety 90 days from the date of receipt at the distributor b HARDWARE interface modules sensors calibration jigs autocalibrators accessories accompanying the SOFT WARE will be free from defects in materials and workmanship under normal use and service for a period of one 1 year from the date of receipt at the distributor Any implied warranties on the SOFT WARE and HARDWARE are lim
65. cording to frequency of transmitter m Rated maximum output power of transmitter W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz D 357P D 1 27P D 2 37P 0 01 0 35 0 23 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 output power rating of the transmitter in watts WW 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 User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 Appendix 6 4 Approved Parts and Accessories arti Description ther 9V DC 500 mA a 5V DC 250 mA via USB oe es o LI25 Interface Module Ty pe 5E 5V DC 250 mA via USB LI24 Interface Module Wireless Type 5 LI26 Interface Module Wireless Type 5E ACC 2021 Interface Power Supply 9V Universal Medical Grade Power Supply Manufactured by Model WM 10 9V 1 PowDec Technologies Input 100 240VAC 50 60Hz 0 4A Output 9VDC 1000mA 7013 Realm Drive Suite E Output Connector 5 5x2 1x 12mm San Jose CA 951
66. ction Scan Initiates the Scan function or hit the F2 E Record button at the top of your keyboard also see the FSA Document Bar lies Skip Backward F4 Action Record Initiates the Record function or hit Rewind F5 the F3 button atthe top of your keyboard also see the gt Play F6 FSA Document Bar Fast Forward FF E Skip Forward F8 Action Skip Backward or F4 or see Navigation Toolbar Action Rewind or F5 or see Navigation T oolbar Remote Setup Action Play or F2 or see Navigation Toolbar Remote Download Action Fast Forward or F2 or see Navigation T oolbar Action Skip Forward or F2 or see Navigation T oolbar Above selections navigate through your collected FSA frames as indicated FSA T ype 4 systems only Action Remote Setup Brings up the Remote Setup window to initiate a Remote session Action Remote Download Brings up the Remote Download window to Initiate the download of the data collected using the Remote feature The option to adjust the remote read frequency is located at Tools System Settings under System or in the Remote Setup window User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 28 User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 Make sure that you wait for the Windows Device Reconnect beep when reconnecting the FSA interface module to your computer If you are running through USB as opposed to Serial you may have to wait a minute or so until the software is able to commun
67. d All rights reserved Windows is a registered trademark of Microsoft Corporation User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 Introduction 3 1 1 3 User Assistance Information If you have any questions about the BodiT rak or FSA Systems or if you are experiencing technical difficulties please contact Vista Medical Ltd at the following address Vista Medical Ltd Unit 3 55 Henlow Bay Winnipeg Manitoba Canada R3Y 1G4 North America Toll Free Technical Support 1 800 847 3157 Local 204 949 7661 Monday to Friday e mail techsupport vista medical com Visit our website at www boditrak com Outside of North America please contact your distributor A listing of our worldwide distributors can be found online at www boditrak com look for the Contact link Before calling for technical support please try the following e Disconnectall cables from the computer then reconnect cables e lfusing a system that uses a battery try a new battery e Close down all programs running except FSA e Re start computer When contacting technical support have the following information ready e Version of FSAsoftware you are currently running Click Help About FSA e Name of your facility company current location and user e Type of computer equipment serial s of interface module if applies and mat s e Note down the error messages if any e Note down any attempted solutions EC Representative regulat
68. e arithmetic mean of the squared dewations from the mean 3 11 12 Vertical Center cm or in The vertical component of the center of pressure as measured from the origin lower left corner of the mat when viewing in the default orientation in the software The units will display in cm or in depending on your Windows location settings User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 e User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 4 4 1 Why is Calibration Needed An uncalibrated mat gives relative pressure information a sensor at 100 is reading its maximum detectable pressure for a given gain The same pressure that one sensor reads as 100 may be read by another sensor as 70 Calibrating a mat defines for every individual sensor the corresponding pressure for example in mmHg of detected pressure at each known for the entire pressure range it also establishes creep and hysteresis values and attempts to correct for these errors Re calibration of the sensors is needed because the sensitivity of the sensors changes over time and use This is especially true for new sensors 4 2 Sensor Array Files The sensor array file contains a detailed description of a sensor array aka mat including the number of rows and columns the recommended range the size and shape of the mat and the shape and colour of its cover and cable Along with this description the sensor array file contains a collection of calibrations
69. e performed at the time of calibration before the apparatus has been disassembled post calibration The option to create a verification file is selected by default verify that is the case by clicking the More Options button found in Calibration Wizard window 3 and viewing that option The software will then step you through creating a verification at the end of the calibration process Once the process is completed review your verification file Itis not saved by default you must save the verification file if you want to keep it Once the calibration assembly has been disassembled a verification file performed on the mat would be invalidated bya number of variables such as changes in the loading of the inflator bag on the mat slight differences in the calibration jig if performed on a mat calibrated elsewhere slight differences in the user performing the calibration etc User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 Optional Accessories 69 5 Optional Accessories 5 1 The FSA Autocalibrator The Autocalibrator automates the calibration process of inflating and deflating the inflator bag when calibrating a mat It provides a more consistent calibration because of the constant pressure increase and decrease Additional Hardware Required 1 USB cable LI 1 Autocalibrator 1 Autocalibrator Power Supply 12V North American or Universal NOTE FSA software version 4 0 219 and up automatically install the USB drivers
70. e print dialog window specific to your printer or use Ctrl P also see the FSA Document Bar selecting OK from this window will print a report in the format currently set up under File Page Setup File Print Preview Previews a report in the format currently set up under File Page Setup Printing from this window will create a report in the current settings found under File Page Setup File Page Setup Opens the Page Setup dialog window For more detail on these settings refer to the chapter Printing Reports File Send Send the FSA file currently open to an e mail recipient To use the computer you are using must have an e mail account configured please refer to your Internet Service Provider or I T support for assistance with this File Exit Closes FSA Up to six of your recent files will appear listed between the Send and Exit commands Clicking on any of those files will open the file The FSA software will open in the folders directories indicated as being the default unless the operator has changed that option under Tools Options Folders or another folder was selected the last time a file was opened For sake of Clarity this users manual will assume the defaults 3 3 2 Edit RA IV Pe ISa r JA Edit Undo Undoes the last editing action performed keyboard shortcut li O K E CTRL Z iE Yor coax a Edit Cut Removes the selected text from the Note Area or the Client en Ctrl C Information tab or FSA frames from
71. e statistics from the entire array you will notice the data in the Statistics field will indicate data from the highlighted area only To deselect the region click outside of the array field within the Contour Panel area The selected region will only be indicated in the Contour Display and Statistics not in the Surface Plot If you are collecting data from a number of regions of the mat you may want to close the Time plot and open the Statistics panel so that it stretches across the bottom of the main display area The columns of statistics will then not run together as example below this display may then saved as a T emplate if you like To adjust display settings see Your Main FSA Display Area rn Client Information Tuesday March 31 2009 mehr OGOOGO O w Minir 0 82 17 43 V Mad 167 80 140 08 VAver 65 28 75 07 v Vane 2346 75 1159 14 vian 4844 34 05 VCoe 73 53 45 35 VHoni 15 57 2737 veti 2748 26 01 T 7i 6 4 iTi 71925 1920 14 8 546849 117 13 4 40 1517 116 6 0 0 111417 167510 0 5 10131616 1 0 0 10111513116 0 The Selectable Areas option does not work with all custom UT5010 mats As of the writing of this manual statistics for selected areas are not exportable individually You will get the statistics for the entire mat User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 Operating Instructions 61 3 11 8 Sensing Area units The area of the mator selected sub section of the ma
72. edical F SA 4 1 T ools your default FSA tool directory Windows Vista and Windows 7 C users YOUR NAME Documents FSA which store your FSA files C Program Data Vistamedical F SA 4 1 Reports your printed report templates C Program Data Vistamedical F SA 4 1 SensorArrays your sensor array files C Program Data Vistamedical F SA 4 1 T emplates your document templates C Program Data Vistamedical F SA 4 1 T ools your default FSA tool directory lf the install is unable to create the directories where intended you will be prompted during the install to make that choice yourself 2 1 2 Upgrading or Re installing the Software If you need to reinstall or upgrade your FSA software Uninstall existing 1 Goto Start Control Panel double click Add or Remove Programs XP Programs and Features Vista Programs Programs and Features Windows 7 2 Select FSA4 1 or 4 0 if uninstalling a previous version from the menu presented click the Add Remove button Vista and Windows 7 Uninstall Change Follow the instructions presented 3 Restart your computer 4 Reinstall as per Software Installation User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 10 User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 2 2 BodiTrak Systems podilrak Components of a BodiTrak System Your BodiT rak system consists of one or more sensing mats pressure or otherwise computer software and often a manual calibration ki
73. eee ee ee 58 aX TT UNNS urria aaasta aana AE AAE aa Ea aAA REA Ka Eea aA E Aa Aa aS 58 Minimum UMIS joii a A E A 58 Regional DSt iIDUUON ssaa Ae a A A a a S E 59 SEIS CLADIC Ar aS inie cous elated a a AE a aaa akae S Eea AEAN a aLa EA 60 SenSiNg Area UNNS Joea a aE aE a a aE E ieee 61 Standard D viation UMIS j maa a aaraa aa a ta eee A E lt Shard cue 61 Statis CES MINIMUM cci aa ee ee eee ek te ete Need ie 61 2012 Vista Medical Ltd i User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 Varlance UNIS iniia a a aa can apicac A E a 61 Vertical Center CMON ors a ee 61 Part IV Calibration 62 1 WhyisCalibration Needed sscccsveccsecaccs cccsncveneenccceccscscseuseenees axcaeszeacenaccsaencaeeeseeneccaxeieezeneexers 62 2 SeN Aa V PES eai a G A 62 3 How OREN 10 Calibrate sinen eerie teeta tae a etisnet oe a veers 63 4 Acceptable Calibration V alUGS visi cicevcccsvestescrceteccetesendcaescevesesees tecasiceereetiesideesseeweseswebeiessteeese 63 5 Calibration Instructions dcsessenseccnsaskccuceaueateateacietewenuetiaaceus suceesnaeicanscasteuaneeteasnss sescussenteauemiatans 64 Assembly of the Calibration Jig nnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn mnnn eee eee ed eens 64 Placem ntof the Sensing Mat screenide aeaeaiue anana Aaaa aaa aa a A E E AE 64 Calibrating the Mat Step by Step snnssnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn
74. een each calibration step as to deflate Increase and decrease the pressure smoothly do not ST OP at each pressure level just reach the pressure hit enter continue on Consistency is the key to a good calibration FSA Calibration Wizard Completing the FSA Calibration Wizard Sensor array UT1010 7014 200mmhg4 cal Range 0 200 mmHg Calibration name 200 mmHg 05 06 2007 e Final frame Click Finish To save the calibration to file click Finish What you will see next if you used the pressurized inflator bag technique is your verification file if you elected to create one View your file to decide if itis acceptable We suggest you save that file in your default FSA4 1 Documents folder as a verification of your calibration If you are not satisfied please return to Tools Calibration Wizard and repeat above The calibration is invalidated if the direction of the calibration pressure is reversed during the calibration Thatis while inflating the inflator bag to the maximum pressure air cannot be released from the inflator bag Similarly while deflating the inflator bag air cannot be added to the inflator bag If you overshoot undershoot the pressure level desired cancel the calibration and start over BodiTrak system calibration files are written to the BodiTrak mat A cal file is produced but itis not used 4 5 4 Calibration Validation Verification Valid verifications of a calibration must b
75. elative humidity should be atleast 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should 1 kV line s to line s 2 kV 1 kVline s to line s 2 kV ibe that of a typical line s to earth line s to earth commercial or hospital environment Mains power quality should be that of a typical lt 5 UT gt 95 dip in UT lt 5 UT gt 95 dip in UT commercial or hospital Voltage dips short for 0 5 cycle 40 UT 60 Ifor 0 5 cycle 40 UT 60 environment If the user of the interruptions and voltage dip in UT for 5 cycles 70 dip in UT for 5 cycles 70 lequipment requires variations on power supply IUT 30 dip in UT for25 JUT 30 dip in UT for25 continued operation during input lines IEC 61000 4 11 cycles cycles power mains interruptions it UT 230 Vac lt 5 UT gt 95 dip in UT lt 5 UT gt 95 dip in UT lis recommended that the for 5 sec for 5 sec equipment be powered from an uninterruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of a typical 2 kV for power supply 2 kV for power supply lines 1 kV for input output lines 1 kV for input output lines lines Electrical fast transient burst Power frequency 50 Hz magned le location in a typical IEC 61000 4 8 DRES commercial or hospital environment User Manual for Bodi Trak and FSA Systems 1st Edition Rev 0 s User Manual fo
76. emplate and make display adjustments every time you use the software it would save time and provide consistency to save your preferred display options so you can repeat them each time you pressure map For example you may want the Surface and Time plots off on your Seat display The resulting display User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 30 User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 N Seat test 3 fsa FSA File Edit view Action Tools Help DO e H a eo Se Heeb i EET en Dee a Client Information March 5 2009 Ew an TT a ME 6 Oe a gA 0 2028 212 7 0 o 0 3 292115 0 0 Minimum mmHg v Maximum mmHg Average mmHg Variance mmHg Ready to read UT1010 7309 00023 March 6 2009 9 12 42 750 AM may be saved as a template as follows Make desired display adjustments to suit your application refer to the section Your Main Display Area for how to achieve this 1 Click Save The Save As window will open 2 Change your Files of T ype drop down at the bottom of your Open window to show fsa and cal files and not only FSA Documents fsa if that is all you are seeing 3 Browse to your FSA4 T emplates directory from the Save In drop down 4 Type a name for your T emplate in File Name this name will appear in your File New dialog and Toolbar New drop down 5 Click Save 6 You can save an existing FSA file with data as a Templ
77. ently selected frame in one FSArecording Click on another thumbnail to toggle between selected frames User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 Operating Instructions 43 Ji T1 11 011 Hovering the mouse pointer over the numerical values displayed in the Contour Plot will trigger a 4 REE Tool Tip pop up that will give you the value of the cell beneath to 1 decimal place M44Ri7 10 6 mmH e Aright mouse click over any of the four display panels will bring up a context menu specific to that panel Left mouse click on an option to select e Cut Copy and Paste if available are explained earlier in this manual see Menu Bar Edit e Flip will give you a mirror image of the both the Contour and Surface plots e You can change how the colours are displayed in your plots by selecting either Show Contours or Show Color Blocks note that you can also toggle the display option Blended Colors bya left mouse click on the Legend colour bar e You can toggle the display of the numerical data on or off by toggling between Show Values and Hide Values Flip Font Size The font size in the FSA display there is text and or numbers in all but the Surface Plot can be adjusted in the context menu from the default Small to Medium and Large surface Plot Statistic Table Time Plot For Show Gradients Show Normals see The Contour Plot a Exclude Minimum Include Minimum removes the values equal to the legend Hide Val
78. er or attention consult accompanying document eee CBs ee a A Electrostatic sensitive device di i Pis Do not dispose of with other waste products contact your distributor or the manufacturer for instructions Refer to instruction manual booklet Class Il equipment FSA system Type 4 Module Start or Stop recording mode FSA system Type 5 5E Module User input required as instructed in manual 6 6 Product Environmental Specifications Temperature Operating 10 to 40 C Storage 40 to 70 C Operating 30 to 75 RH non condensing Storage 10 to 100 RH non Relative Humidity condensing Atmospheric pressure Operating 700 to 1060 hPa Storage 500 to 1060 hPa User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 torn TT 7 Glossary Autocalibrator An optional FSA device that automates the calibration process Average The average of the sensor values For further detail see Statistics Average Coefficient of Variation Astatistical measure of the deviation of a variable from its mean For further detail see Coefficient of Variation section Collapse Expand Arrow The triangle in the center of display section splitter Click on the Collapse Expand arrow to close or open a display section Context Menu Pop up menus that appear with a right mouse click The menu that appears is dependant on where your focus is what area of the screen you are on and where your cursor is when you right c
79. erification file C Use the autocalibrator Fewer Options Increasing the Creep Time will increase the time it takes to perform your calibration Applied weight calibration FSA Calibration Wizard Weight EA Please enter your weight and apply it to the sensor array e This technique is recommended for seat and bed mats only e For seat place the FSAsensing maton a typical seating surface Weight aS Mogens and sit on it Lift your arms and legs up so all your weight is supported by the mat For bed place the maton a typical bed and lay on the mat in a manner so all your weight is supported on the This calibration technique is recommended for Seat and Bed mats only m at Enter your weight and apply all your weight to the sensor array then click Next If you are calibrating a Seat mat place it on a typical seating surface and sit on it lift your feet and arms up so all your weight is on the mat Likewise if your using a Bed mat lay the mat on o Cl C k N ext a typical bed and then lay on it User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 e User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 The Calibration Wizard will step you through the calibration instructions depend on which technique you chose If calibrating using the inflator bag you will be instructed to increase and decrease the pressure step bystep Take the Same amount of time to inflate the inflator bag betw
80. ers If your module cannot be auto detected go to your Windows Control Panel System Hardware Device Manager Double click on Ports COM and LPT look for USB Serial Port and take note of which COM number it is assigned to Go to your FSA Tools System Settings click on the Interface Module icon and select the port number you found Click OK Tryscanning again lf running through an external USB to serial adaptor your USB to serial adaptor may not be securely connected or it may not be installed Look under Control Panel System Hardware Device Manager Ports COM and LPT to see if you see the device and note which COM portitis installed to USB to serial adaptors require a driver be installed in order to function If you are unable to locate your USB to serial adaptor software please contact the vendor of your device try looking on line drivers are typically available for download at the adaptor vendors website e The FSAinterface module may not work if your hardware is connected to your laptop through a docking port The laptop will have to be disconnected from the docking port and the FSAhardware connected directly to the serial or USB port e lfrunning on a laptop on battery power try AC power e Ifyou are still unable to resolve the problem contact FSA technical support How do set up the software to read every 10 seconds How do you convert Hz to an actual time span Adjust the Scan or Remote frequency under Tools Sys
81. for you If you are running an earlier version install the newest version Autocalibrator Setup 1 Setup the calibration jig as outlined in the calibration procedure and place the matin the jig as instructed 2 Connect the inflator bag to the Autocalibrator One of the connections is for the air pump and goes to the Autocalibrator Pump outlet the other is for the internal pressure gauge and goes to the Autocalibrator Gauge outlet An external pressure gauge can be connected to Autocalibrator by using a T connector not supplied 3 Plug the LI USB cable into the Autocalibrator USB slot on the back of the device and an open USB port on the computer 4 Plug the 12V Autocalibrator Power Supply into the Autocalibrator and into the wall outlet 5 Goto Tools Options and click the Hardware tab For a USB Autocalibrator select the Alone on option and choose your COM port To determine which COM port you are on check your Windows Device Manager found under Start Control Panel System Hardware Device Manager Look under Ports COM and LPT for USB Serial Port It will give you a COM number Close out of Device Manager FSA Options General Folders Hardware Sensor Arrays InterFace Modules UT 1010 4249 200mmHg4 Number available 2 UT1010 4274 200rmHg4 w UT1010 4275 200mmHg4 UT1023 0002 00mmhg4 Autocalibrator UT1024 0001 200rnmHo4 None Sensor matrix 16x16 In series with interface module Sensing area 40 6
82. found to comply with CAN CSA C22 2 No 60601 1 2008 ANSI AAMI ES 60601 1 2005 A2 2010 and EN 60601 1 2006 A11 2011 The following information is provided for clarification e Medical Device T ype Class with measurement function e Degree of protection against electric shock Type B Applied Part e Degree of protection against ingress of water IPX0O e Degree of safety of application in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide Equipment not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide e Mode of operation Continuous e Environmental Operating Conditions 10 40 C 30 75 rH non condensing 700 1060hPa 6 2 2 Electronic Emissions Notices Federal Communications Commission FCC statement The Federal Communications Commission in 47 CFR 15 105 has specified that the following notice be brought to the attention of the users of this product This equipment has been tested and found to comply with the limits for a Class Adigital device pursuant to Part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instruction manual may cause harmful interference to radio communications Operation of this equ
83. further detail see Regional Distribution section Remote Remote permits interface pressure measurements to be made with the interface module disconnected from the computer Scan Engage and disengage the Scan keyboard shortcut F2 button to record a single frame Once you initiate a Scan you will see a live image in your FSAwindow No frames are captured until you disengage the User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 torn TT Scan the last image viewed will be saved as a frame Repeat to capture additional frames Selectable Areas Aselectable sub section or sections of an FSA array indicated bya thick coloured line For further detail see Selectable Areas section Selected Frame Frames in which a purple check mark appears near the center of your FSA status bar useful for exporting data Sensing Area The area of the mat or selected sub section of the mat whose readings are at or above the statistics minimum For further detail see Sensing Area section Sensor Array Asensor array file contains a detailed description of a sensor array aka mat including the number of rows and columns the recommended range the size and shape the colour of its cover and cable as well as at least one calibration file The sensor array file has a cal extension Also refer to Calibration Sensor Array Files Splitters ci CollapseExpand arrow Splitters are the visual dividing lines between each display panel contai
84. g the Computer Interface Module and Mat Via Serial Port Type 4 modules only gone or the other Rear view of FSA Interface Module 1 Locate the FSA Cable LI3 interface module and Interface Power Supply ACCHHE H 2 Plug the LI3 FSA Cable s 9 hole plug 9 pin serial port adapter securely into a 9 pin receptacle serial also known as COM port on the back of the computer If the AC port on the hood makes this awkward plug the FSA serial port extension LI5 into the COM port and the FSA cable into its other end 3 Plug the Interface Power Supply into the receptacle attached on the top of the FSA cable s 9 hole plug or into the back of the interface module 4 Plug the FSA cable s 8 wire plug into the back of the interface module 5 Plug the Interface Power Supply into a power source If connected properly the green light on the interface module will illuminate indicating the interface module is receiving power 6 Find the FSAmat Plug the mat s ribbon cable securely into receptacle Aof the interface module Use receptacle B for a second FSA mats ribbon cable Be sure to keep the connector straight when inserting and removing so as not to bend the pins lf the green light is not illuminated does the power source work Is the Interface Power Supply secure On some laptops the lights will not illuminate until a scan or record is initiated If initiating a scan does not illuminate the lights please refer to the section Frequently
85. gend on the right hand of your screen you may have to adjust your display range to suit your selected calibration range see I he Legend Display Panel The following is optional but highly recommended it avoids your having to change your display every time you want use a range other than the default 1 Before collecting any data make any other changes to your display you would like then go to File Save as Template 2 Name your new template for your mat and calibrated range 3 Click Save Repeat above for as many calibrated ranges as you have In future all you need to do is select the suitable template from File New you would not have to make the adjustments every session you change from the default range User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 6 6 1 FAQ s think installed my Seat Mat sensor array files correctly yet when choose the Seat template am unable to choose the correct sensor array file There is more than one style of Seat mat The Template you see by default is the typical and most common 16 x 16 array with a 17 x 17 sensing area Check your serial number from the mat cable label If your seat mat serial number starts with any of the following UT 1020 UT 1021 UT 1022 UT 1023 UT 1024 UT 1025 UT 1026 UT 1027 you need to create a T emplate for your style of seat mat To do so either create a template from T ools
86. he Video Window in the lower right of your FSA display to the right of the Note Area and below the Statistics and Legend see Adding Video e Toresize the Video Window click and drag the horizontal dividing bar between the Video Window and Note Area and the Contour Plot and Statistics areas e To close the Video Window click on the arrow on the vertical bar dividing it from the Note Area e Cut Copy or Paste the image in the Video Window byright clicking over the Video Window and selecting the desired option from the context menu that appears The image will be copied to the Windows clipboard and can be pasted into another FSA frame another FSA file or third party software that accepts a bitmap from the Windows clipboard an image editor a word processor etc User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 52 User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 3 5 11 The Scroll Bar oy Move forwards and backwards through frames in your file by either h e Left mouse clicking on the up or down arrows in the scroll bar Ar e Left clicking and dragging on the scroll bar button located on the right hand side of your main FSA display area v e AT ord e Roll the wheel on your mouse User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 Operating Instructions 53 3 6 Remote FSA Type 4 Systems Only Remote reading adds flexibility to the FSA tool by permitting interface pressure measure
87. he text or image can then be pasted into compatible software a word processor spreadsheet or image editor for example db Click on the Cut button to remove the selected text or FSA frame from the FSA software and paste it to the Windows clipboard Also see Menu Bar Edit Cut The text or image can then be pasted into compatible software a word processor spreadsheet or image editor for example B Pastes textual data previously copied or cut to the Windows clipboard into your Client Information or Note Area or Pastes copied or cut FSA frames currently on the Windows clipboard into an FSA file Also see Menu Bar Edit Paste E iias the Scan function or hit the F2 button at the top of your keyboard also see Menu Bar Action Scan Initiates the Record function or hit the F3 button at the top of your keyboard also see Menu Bar Action Record 3 4 2 The Navigation Bar The Navigation Bar allows you to view your collected FSA frames as indicated below tea Skip Backward Click to jump backwards through file Key frame to Key frame or in the absence of Key frames end to start of file 4 Rewind Click to start action click again to stop Play Click to start action click again to stop a Fast Forward Click to start action click again to stop Skip Forward Click to jump forwards through file Key frame to Key frame or in the absence of Key frames start User Manual for BodiTrak and FSA Systems 1st Editi
88. holding the button reconnect the USB cable Release the button and confirm that only the yellow light i blinking then click Next Interface module Note The interface module already has the correct firmware 1 11 Example frames 2 and 3 NOTE Ifthe software is unable to determine the module type due to the firmware being scrambled or otherwise or the module is not connected and powered you will see the frame on the left If the software recognizes your module you will skip straight to the frame on the right example shown is for Type 5 Type 4 differs make sure to follow the instructions The software will also indicate what firmware is already loaded on your module and whether you need to perform this task If you already have the latest firmware you may click Back to return to frame 1 and click Cancel lf you are unable to upload the firmware on your module contact technical support techupport vista medical com 3 3 5 8 Calibration Wizard The Calibration Wizard is a utility that will step you through calibrating your FSA mat Please refer to Calibrating the Mat Step by Step for detailed instructions on calibration 3 3 5 9 Options Tools Options General Click on the General tab to select or deselect general program options e Choose to receive a warning before deleting frames e Choose to allow the software to automatically detect your hardware which port your interface module is connected to at FSA start up
89. icate and the data downloaded to the computer 3 3 5 Tools i LN ee File Edit View Action item Tools System Settings Opens the System Settings Help E 2 gl window SE calibration Wizard Tools Calibration Wizard Opens the Calibration Client Information March 5 20 Wizard Create Template Seating eee Wizard Create Template Opens the FSA Template Creator tool Tools Seating Protocol Wizard Opens the FSA Seating Protocol Wizard Tools Options Opens the FSA Options window where you can 1 Change general program options 2 Change the locations of your default FSA folders Tools will in time be available for download from our website Any installed tools will appear under this heading if installed correctly Note that FSA Tools are Java Script files you may have to get your IT department to allow you to download install and run Java Scripts Options Ready to read UT1010 1234 HINT you can also access System Settings by left clicking Click HERE over the FSAsystem status information in the left side of your Status Bar User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 Operating Instructions 29 3 3 5 1 Create Template Template Name Available Sensor Arrays Selected Sensor Arrays UT1010 7484 One sensor array per interface module The Template Creator is a tool that enables the FSAuser to create their own templates from their mats FSA4 1 sensor array
90. ipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense The end user of this product should be aware that any changes or modifications made to this equipment without the approval of Vista Medical could result in the product not meeting the Class Alimits in which case the FCC could void the user s authority to operate the equipment This device complies with Part 15 of the FCC Rules Operation is subject to the following two conditions 1 this device may not cause harmful interference and 2 this device must accept any interference received including interference that may cause undesired operation Industry Canada compliance statement This Class Adigital apparatus complies with Canadian ICES 003 Cet appareil num rique de la classe Aest conforme a la norme NMB 003 du Canada User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 IEC 60601 1 2 2007 Ed 3 0 This product has been tested and found to comply to IEC 60601 1 2 2007 Ed 3 0 for electromagnetic compatibility EMC asa Class Aproduct The tests performed and test levels are listed in the accompanying tables The user operator or installer of this equipment is advised of the following 1 In a domestic environment this product may cause radio interference in which case the user may be required to take adequate corrective measures 2 Portable and mobile RF communications can affect
91. it is acceptable see Acceptable Calibration Values We suggest you save the verification QC file for your own reference The verification file is also useful in case you need to contact T echnical Support Note that any air leak in the system will invalidate the calibration 5 2 FSA Wireless Kits FSA Systems Only Wireless Kits Type 4 and 5 5E The FSA Wireless Kits enable wireless Bluetooth data collection between your FSA Interface Module and computer The kits are comprised of a Wireless Serial Adaptor Bluetooth USB Adapter and required cables and connectors the T ype 4 Wireless kit connects to your existing FSA Type 4 Interface Module T ype 5 SEkits require the L124 L126 Interface Module Wireless T ype 5 5E Standard LI20 Type 5 or LI25 T ype 5E Interface Modules do not accept this kit The basic kits ship with a 1 dB stub antenna on each adaptor which gives you a range of up to 100 meters Optional extended range antennae may be purchased that extend the range as follows 1 dBi 1 stub antenna to 1 dBi stub antenna up to 100 meters 1 dBi stub antenna to 3 dBi 4 dipole antenna up to 150 meters 3 dBi dipole antenna to 3 dBi dipole antenna up to 200 meters 3 dBi dipole antenna to 5 dBi 6 dipole antenna up to 300 meters 5 dBi dipole antenna to 5 dBi dipole antenna up to 400 meters Full set up instructions are supplied with the kits Wireless Kits are not compatible with Type 4 Interface Module series 4D and 4E
92. ited to ninety 90 days and one 1 year respectively some states jurisdictions do not allow limitations on duration of an implied warranty so the above limitations may not apply to you CUSTOMER REMEDIES Vista Medical Ltd and its suppliers entire liability and your exclusive remedy shall be at Vista Medical Ltd s option either a return of the price paid or b repair or replacement of the SOFTWARE and or HARDWARE that does not meet Vista Medical Ltd s Limited Warranty and which is returned to Vista Medical Ltd s with a copy of your invoice This Limited Warranty is void if failure of the SOFT WARE and or HARDWARE has resulted from accident abuse or misapplication Any replacement modification or enhancements to the SOFTWARE and or User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 2 User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 HARDWARE will be warranted for the remainder of the original warranty period or thirty 30 days whichever is longer Any modifications bya third party to the SOFT WARE and or HARDWARE will void the manufacturer s warranty and any obligations to provide maintenance services NO OTHER WARRANTIES To the maximum extent permitted by applicable law Vista Medical Ltd and its suppliers disclaim all other warranties either express of implied including but not limited to implied warranties of merchantability and fitness for a particular purpose with regard to the SOFT WARE the
93. ith the thin side smooth of the inflator bag contacting the mat label facing the mat iv Platen 4 Grip the top and bottom platen and slide them into the calibration jig Do not permit platens to slide over each other and disturb the placement of the mat or inflator bag and ensure platens are protruding equally from both ends of the jig and ensure that the inflator is fully contained and supported between the platens 5 Attach sohygmomanometer to one length of latex or neoprene tubing 6 Attach air pump assembly to other length of latex or neoprene tubing see below 7 Insertthe mat s cable into the computer BodiT rak or interface module FSA Systems The High Pressure calibration kit inflator tubing and connectors are assembled pre shipping The standard calibration kit air pump side assembles as follows Inflator amber tubing chrome release valve amber tubing white nylon connector black tubing to air pump FSA systems only Seat and Back systems are always calibrated using the Seat Template one mat ata time mat connected to Port Aof your interface module Non rectangular custom sensors may have specific unique calibration requirements Please refer to the documentation on the CD that shipped with your system User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 e User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 4 5 3 Calibrating the Mat Step by Step 1 Setup your calibration equipment as pe
94. ity to record video does not equate to streaming video however you can still drag and drop digital images into your FSA file Look for a Web cam style camera to use with the FSA system If you need suggestions please contact techsupport vista medical com lf your camera is connected and you do not see a camera listed when you go to Tools System Settings your camera is either not installed properly or is not WIA or VFW compatible Refer to the documentation that came with your camera to re install it For optimum results when using FSAwith video we strongly advise that you have at least 4GB of RAM the more the better FSA files with video included can be 10 or more times larger than the same file without video Computers with insufficient RAM may not display video The Quality settings available under the Quality drop down depend on your camera To keep the file size manageable we suggest you select the lowest resolution available initially and try it out lf you have copied an image to the Windows Clipboard and cannot Paste it into the FSA Video window click in the FSA video window to make sure your cursor focus is in that window If the Paste option is grayed out the image format is not compatible 3 8 Printing Reports Initiating the print function directly from the Print button in your toolbar or File Print from the FSA Menu bar or keyboard shortcut CTRL P will produce a report using the current default settings if you have not used
95. k and FSA systems ships in a separate box and includes the following Platens 2 are included size is dependent on the mat dimensions Fingers typical The number and design varies with the mat dimensions and system purchased errs ketit eet Hetet Ettr t ttit ttr ETETETT EEEE caste ste ta aa shea este ate ate te oe ate ate ees Sao eS teii zs SERS SE SS Oe eo a oe SOE OH Slots typical The number and design varies with the mat dimensions and system purchased R HHH KEK HHTH PEPPE EEEE PERHEET i PHPHRHEHTEE KR Aneroid Sphygmomanometer 1 type depends on system ordered Air Pump and Chrome Valve 1 type depends on system ordered Inflator Bag 1 type depends on system ordered Latex or Neoprene Tubing 2 lengths type depends on system ordered WARNING The calibration apparatus has been designed to calibrate your system to the pressure indicated on the label on your calibration jig platen For safety reasons do not exceed this value User Manual for Bodi Trak and FSA Systems 1st Edition Rev 0 22 User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 2 5 Sample Session For this example we are using a Seat and will leave the display options at their default settings lf the option is selected under Tools Options the COM port your interface module is connected to will be automatically detected when the FSA software is started up 1 Open FSAby double clicking on your desktop icon 2 BodiT rak go
96. l 17 Serial cable 17 Serial Port 16 Setup 16 17 Shear 71 Shipping Tube 10 14 15 Show Centers 42 Show Color Blocks 42 46 Show Colour Blocks 46 Show Contours 42 46 Show Gradients 42 Show Normals 42 Skip Backward 27 39 Skip Forward 27 39 Slot 21 e User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 Slots 64 Software 8 9 Speed 34 72 Sphygmomanometer 21 Splitters 42 45 91 Standard Deviation 61 91 Star 41 Starred Frames 41 Statement of Accuracy 5 Statistics Display 50 Statistics Minimum 61 91 Status Bar 27 40 91 Strip 71 Surface Plot 48 91 System Requirements 4 System Settings 28 33 34 System status 40 me Technical Support 3 Template 28 29 91 Template folder 36 Templates 29 Thumbnails 45 Time 40 Time Plot Display 50 Title Bar 24 Tool Bar 38 Tools 28 Tools folder 36 Tools Options 36 Tools Options Folders 36 Tools Options General 36 Tools Options Hardware 36 Tubing 21 TypeS 19 Type lV 19 U UL 60601 1 81 Unable to read 40 Unlock Regions 42 Upgrade 9 Upload Firmware 35 USB 16 18 USB Drivers 18 Use Camera 33 34 Use Video 55 User Assistance 3 aUa Validation 63 68 Values 63 Variance 61 91 Verification 68 Version 37 Vertical Center 61 91 Vertical Centre 61 Video 33 34 51 55 Video Window 51 View Normal 27 W Warnings 6 Warranty 1 Web site 3 WEEE 5 Windows 7 8 Windows Vista 8 Windows XP 8 Wireless 70 2012 Vista Medic
97. l i ESD IEC 61000 4 2 6 kV contact 8 kV air with documented floors are covered with synthetic material the necessary relative humidity should be at least 30 ransentiousiiec nest KV for ines thV for Mais power quailty shoud be that ofa typica 61000 4 4 input output lines inputoutput lines ospital en t i 1 kV line s to line s 1 kV line s to line s Mains power quality should be that of a typical Surpa EL GN 2 kV line s to earth 2 kV line s to earth commercial or hospital environment lt 5 UT 295 dip in ie at mae Voltage dips short UT for 0 5 cycle 40 UT 60 di A UT for Mains power quality should be that of a typical interruptions and UT 60 dip in UT for 5 cycles 70 UT 30 commercial or hospital environment If the user of voltage variations on cycles 70 UT 30 dip n UT for 25 cy ode a the equipment requires continued operation power supply input dip in UT for 25 cycles No enonialiee during power mains interruptions it is lines IEC 67000 4 11 recommended that the equipment be powered UT 230 Vac lt 5 UT gt 95 dip in 95 dip meets from an uninterruptible power supply or a battery UT for 5 sec requirements Power frequency 50 Power frequency magnetic fields should be at Hz magnetic field IEC levels characteristic of a typical location in a 61000 4 8 typical commercial or hospital environment User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 s
98. lated with air to apply an even pressure to the sensing mat during the calibration process Isolation Bag Clear thin polyethylene bags supplied with standard FSAsystems intended to be slipped over the sensing matin order to protect the mat from body fluids or other liquids as well as shear and torque forces Key Frame Frames in which an illuminated star appears near the center of your FSA status bar Setting key frames is useful when working with recordings containing a large numbers of frames Maximum Maximum indicates the highest individual sensor value in the displayed frame For further detail see Maximum units section Minimum Minimum indicates the lowest individual sensor value in the displayed frame For further detail see Minimum units section Record Engage and disengage the Record keyboard shortcut F3 button to record a series of frames a movie if you like Once you initiate a Record you will see a live image in your FSA window All frames will be captured once the Record is disengaged Recording When you collect data with your FSA system using either the Scan or Record function you create a recording An FSA document file can contain one or many recordings created from different sessions different styles of mat or saved templates Excluding the Client Information tab each tab in your FSA display represents a separate recording Regional Distribution Percentage of total load selected in each region For
99. lick dependant on the context in other words Contour Plot By default the largest component of your FSAdisplay the 2D representation of your mat containing the pressure values and isobars Creep Creep is the tendency for pressures to steadily increase under load itis a function of time In FSA software creep correction is applied from the time the sensors are initially scanned and is reset to zero each time the sensor readings fall to zero Documents In the context of FSA documents or documents directory refer to your FSA patient files The files will have an fsa extension Gripper The dotted lines in the display section splitter Left click and drag on the gripper to re size your display sections Horizontal Center The horizontal component of the center of pressure lower left corner of the mat when viewing in the default orientation in the software Hysteresis Energy lost when loading or unloading a sensor Basically relating to the FSAsystem this means when you measure a pressure applied coming from a lower pressure you will get a lower pressure than if that same pressure is applied User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 92 User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 coming from a higher pressure FSA software is designed to manage hysteresis Inflator Bag Inflator bags a component of the calibration apparatus are sealed polyurethane bladders with two outlets inf
100. llows the FSAoperator to compare different frames in a single file Select a quadrant by left mouse clicking on it The Scroll bar will appear Scroll through to select a frame select the next quadrant scroll through to select another frame and repeat in the third and fourth quadrants to compare frames side by side The currently selected quadrant will have a white as opposed to gray background in above example itis the quadrant in the lower right That frame is active e if you initiate a scan the selected quadrant will be live e you can scroll through frames in the selected quadrant as you would in a normal view with the scroll bar or mouse wheel e changing display options is not available in Comparison view you must be in Normal view e only 1 line of any text in the Note Area will be visible in Comparison view User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 Operating Instructions 45 3 5 2 Thumbnail Display Client Information Recording E5 is Lett lechial tuberosity This is his driving postion This is his computer position for driving the rouse T DD 7 3 3 4a 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 T Minimum mmHg 0 00 T Masimurn mmHg 99 61 v Average mmHg 14 11 T Vanance mmHg fod 4d Standard deviation mmHg 16 95 Coefficient of variation 72 113 06 The Thumbnails Display appears when you left mouse click on the Collapse Expand
101. mail After installing the file check your status bar and look for the serial number If you do not see the serial number Make sure your sensor array cal file s are in your default sensor array directory using My Computer or Windows Explorer the default directories are shown under T ools Options Folders If you do not have sufficient user rights to do this contact your I T department Select the template that matches your FSAsensing mat from File New Make sure your software is looking for your sensor array cal files in the correct location Using My Computer or Windows Explorer search for your cal file s Take note of their location then go to Tools Options Folders and Browse to that directory Click OK have recalibrated my mat but cannot find access the new calibration have recalibrated my mat but cannot find the new file in my Sensor Array directory Go to your SensorArray directory using My Computer or Windows Explorer the default directories are shown under Tools Options Folders If you do not have sufficient user rights to do this contact your I T department Find the sensor array file for your mat look for the file with your serial number in the filename Right click over your mats sensor array file then left click on Properties from the pop up menu that appears On the General tab under Attributes make sure Read Only is not selected If itis deselect that option then click OK
102. may be required if using two high resolution over 16 x Sensor matrix 16x16 In series with interface module R EARN alt 16 FSAmats together for exam ple a seat and back Range 0 200 mmHg e Configure your optional FSA Autocalibrator so see The FSA Autocalibrator BodiTrak mats do not appear in the Sensor Arrays list their Sensor array file is not installed on your computer it is on the mat 3 3 6 Help Clicking on Help FSA4 Help will bring up the software help file the contents are the same as this manual Clicking Help About FSA will give you the software version you are running You may need to know this if contacting FSA Technical Support or searching for help at www boditrak com User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 38 User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 3 4 The Tool Bars Click on a button to initiate an action 3 4 1 The Document Bar d P aie XB 2 Clicking the Open button will bring up your default FSA Documents window and allow you to open and existing FSA file Select the file you wish to open then click OK Also see the Menu Bar File Open T Click on the Save button to save any changes made to your file since the last save If saving for the first time the Save As window will open in your default FSA file directory prompting you to name the file Type a name in the File name window then click Save You can save the files as they are o
103. ments to be made with the interface module disconnected from the computer This feature is useful to the user in situations when itis desirable to test the client in situations where the computer cannot be transported such as in a moving vehicle or when testing a client over a prolonged period of time Briefly the interface module is programmed to take pressure measurements at user selected preset time intervals The interface module is then disconnected from the computer The remote readings are initiated and stored in the interface module The interface module is reconnected to the computer and the data Is transferred into the computer The interface module stores 114 600 individual sensor reads The maximum number of frames the interface module stores per remote session is a function of the number of sensors in the mat Examples Atypical FSA Seat mat has 256 individual sensors 16 x 16 256 114 600 256 448 The interface module can store 448 Standard Seat mat frames Atypical FSA Bed mat has 1024 sensors 32 x 32 1024 114 600 1024 112 The interface module can store 112 Standard Bed mat frames Switch your power source to battery before setting up the remote session ifthe energy supply is disrupted after presetting the interface module the preset remote reading instructions are lost Once data has been collected to your module you are able to disconnect power from the module without data loss for 48 hours Additional reads c
104. n Rev 0 Operating Instructions 57 NOT E Different templates will be made available in the upcoming months Please check with FSA Technical Support at techsupport vista medical com or at www pressuremapping com 3 9 The Client Information Tab Enter client file specific notes here such as name date of birth relevant medical history etc You can create a form by typing or pasting in what you would like to appear on all your Client Information tabs for one or all of your document templates and saving it as a template save it in to your FSA4 T emplates directory Example 1 Open a Seat document template from File New 2 Click the Client Information tab 3 Type Name Address Phone 4 Click File Save As Template to save the file in your FSA4 T emplates directory When you next open Seat from File New you will see that the Client Information tab will contain the information you typed in 3 10 Exporting 3 10 1 What can be exported from the Software Export FSA data numerical or graphical to any external programs that support bitmap BMP or enhanced metafile EMF formats for graphical or T XT text for data 3 10 2 Exporting a Graphic 1 Select the frame you wish to export the visual from See Selecting Frames 2 Select Edit Copy from the FSA Menu Bar 3 Open the external program that supports the bitmap omp or enhanced metafile emf file format an image editor or word processor 4 Goto Edit
105. n that directory User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 Operating Instructions 33 3 3 5 4 System Settings FSA Systems Click on an icon to view and change system settings for FSA mats running through an Interface Module serial numbers starting with UT or ST FSA System Settings BA System Interface Module O UT1010 4372 200mmhg4 Logitech QuickCam Chat Scan frequency Hz 30 Remote frequency Hz 5 C Use camera when available FSA System Settings 4 System 6 Interface Module Port COMS y m UT1010 4016 200mmHg Creative WebCam Instant 4 High speed Upload firmware Dialog g System 3 63 Interface Module M 0710101324 Sensor Aray UT1010 1324 v Calibration Always use the newest calibration J O Time 29 03 1935 8 36 PM Range 0 200 mmHg User Manual for Bodi Trak and FSA Systems 1st Edition Rev 0 Clicking on System will allow the operator to change e the Scan Frequency in Hz program default is 5 e the Remote Frequency scan rate in Hz program default is 5 1 reading per second 1Hz 1 reading every 10 seconds 0 1H7 etc e select or de select Use camera when available Clicking on the camera icon will bring up your camera options see Adding Video Clicking on Interface Module will allow the operator to e change the Port the Interf
106. nd under User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 Operating Instructions 41 your Windows Control Panel 3 4 4 Key Frames A Key Frame is not the same as a Selected Frame the latter option is intended to be used in editing and printing operations The Key Frame option was developed to allow the FSA operator to mark specific frames in a file containing a high number of frames typically a file that was collected using the Record and not the Scan function and quickly view just those frames instead of going through a large file frame by frame searching for key information e You can mark a frame as a Key Frame manually by clicking the star outline ed ele n your Status Bar in whatever frame or frames you like The star will appear illuminated if selected To view only your key frames e Hold down the CTRL key and scroll through your FSA file using the wheel on your mouse if you have a wheel mouse the UP and DOWN arrows on the scroll bar on the right side of your colour bar or by hitting the ort keys on your keyboard Only the frames selected as key will show If you release the CT RL key all frames will show e Use the Skip Forward or Skip Backward functions in the Navigation T ool bar An illuminated star will show in the FSA Status Bar if a frame is selected as a Key Frame La aS OO045 March 6 2009 9 12 435 156 AM As of the writing of this manual FSA software automatically marks as
107. ning 2 grippers and a Collapse Expand arrow and are hidden by default To show splitters right click anywhere over your main display area and select Show Splitters from the context menu that appears Conversely if you wish to hide them right click to pull up the context menu and select Hide Splitters Standard Deviation The square root of the variance For further detail see Standard Deviation Statistics Minimum The minimum sensor reading that will be included in all statistics calculations excepting Minimum and Maximum For further detail see Statistics Minimum Status Bar The horizontal bar running across the bottom of your FSA display that indicates the system status frame number date etc Surface Plot The 3D representation of your matin your FSA display Template User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 94 User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 Atemplate is an FSAdocument that is stored in the Template folder To scan a sensor array you must first open a template or other document that is designed for the sensor array you have You will see your available Templates when you go to File New For example fora UT 1010 Seat mat you select Seat from File New to use two UT 1010 Seat mats together as a Seat and Back select File New Seat and Back Variance Ameasure of the variability or dispersion of individual sensor values around the
108. nnnnnnnnnnnn nannan nnana nnna 66 Calibration Validation Verification sssnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nnmnnn nnana nnmnnn 68 Part V Optional Accessories 69 THe FSA AULOCAINDFAlOR micrones a E e ria 69 2 FSA Wireless Kits FSA Systems Only ccceceeceeeeeeceeeeeeeeeeeeeneeeeneesoeseseesnsesensesensesonseseeeaees 70 3 Custom Sensors and Mats ansannannunnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nunne nnmnnn nnn 71 Part VI Appendix 72 1 FAQS i a e a a e a E 72 2 Safety Notices BodiTrak System sassnssnnsnnnunnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nnmnnn 76 CANCSA C22 2 No 60601 1 2008 ANSI AAMI ES 60601 1 2005 A2 2010 and EN 60601 1 2006 A11 2011 76 Hectronie EMISSIONS NOCES aia a a aE a AT 76 Medical Electrical Equipment Classification cccsssssseeeessseeeeeeeeesseneeeseseeeeeeeseseeeeeseseneneeseeeeeeseeeseeeeeenneneeeens 78 IEC 60601 1 2 2007 Ed 3 0 Tables BodiTrak Systems sscssssssssssssssssssssessessessesecsssasseesaeseeessesatsoesnesees 78 3 Safety NOUCES FSA SVAREN suraia aE a A R a A EARNER EA OERA 81 CAN CSA C22 2 601 1 M90 UL 60601 1 and EN60601 1 ccccssssssssssseseesseseessaeseeseeseeseeaessesanseeseesesaeseeseesees 81 Hectronic Emissions Notices FSA Systems ss sssssssnsennsnnnennnennnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn ennenen 81 IEC 60601 1 2 2004 Ed 2 1
109. nvironment guidance The equipment uses RF energy only for its internal function Therefore its RF emissions CISPR 11 Group 1 RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class A The equipment is suitable for use in all establishments other than domestic and may be used in domestic establishments and those direclly connected Harmonic emissions IEC to the public low voltage power supply network that supplies buildings used 61000 3 2 Class A for domestic purposes provided the following warning is heeded Waming This equipment system is intended for use by healthcare professionals only This equipment system may cause radio interference or may disrupt Voltage fluctuations flicker l the operation of nearby equipment It may be necessary to take mitigation ae j Complies measures such as re orienting or relocating the equipment or shielding the location User Manual for Bodi Trak and FSA Systems 1st Edition Rev 0 Table 202 Requirements The equipment is intended for use in the electromagnetic environment specified below The customer or the user of the Equipment should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance raat 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If Electrostatic discharge e uur nnn EV a
110. o point Windows to the location of the drivers Click on the directory Click OK then Next 7 Windows will install the USB Serial Converter and the USB Serial Port or it will install one then the other Follow the on screen instructions if there are any Windows may install the drivers without any input from you in which case you can see the progress in your notification area in the lower right of your Windows screen 2 3 6 Proper Care of the FSA Mat e Do notfold the mat e Keep the mat dry Protect the mat from incontinence torque and shear forces by using the isolation bags provided e Place the mat gently on surfaces by using the corners e Do not pull on or carry the mat by the ribbon cable e Do notpivoton the mat e Do not pull on the edges of the mat while itis under a client e Do notpinch the mat between moving components of a support surface e Store the mat flat or in the original packaging roll the mat around the foam core and store in the shipping tube 2 3 Proper Care of the FSA Interface Modules e Do not drop the interface modules e There are no user serviceable parts in the interface modules do not open them e Protect the interface modules from exposure to moisture e Store the interface modules in a location where it is protected from falling or in the original packaging inside of the foam core store in the shipping tube e The Type 4 Interface Module operates on 9V DC or battery power To protect against p
111. on Rev 0 a User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 to end of file 3 4 3 The Status Bar The FSA Status Bar reports the FSAor BodiT rak system status along with other information as follows Ready to read UT1010 1234 NAG Ready to read indicates the system is ready to read and start a new file FSA Systems Appropriate sensor array files available and an FSA Interface module connected BodiT rak systems A BodiT rak mat is connected to the computer The light remains gray if a scan or record is not engaged FSA systems only if you own more than one mat verify the serial number matches the mat plugged in to your interface module No information on the right indicates a new file Ready to read UT1010 1234 N A 00004 March 31 2005 02 08 06 500 PM Above indicates system ready to read using the sensor array indicated The information on the right indicates an existing file is selected and ready to be added to The star and check mark outlines will appear in an open file but not a new file that has yet to be saved They are the Key Frame and Selected Frame indicators Click on the outlines to select or deselect also see Menu Bar Edit and Key Frames 9 Not ready to read The required sensor array files are not installed N A Not ready blue light indicates FSA Systems There is no sensor array file available for the selected template in your SensorArray directory and or there
112. on area in the lower right On initial connection to a computer running on the Windows XP operating system the Found New Hardware wizard will appear Follow the onscreen instructions to install the driver When you connect and disconnect a USB device you should hear a tone from your computer Wait to hear that tone before scanning Under Windows System Device Manager BodiTrak mats show up as BodiTrak Sensor Array branching off of Bodi Trak Device Your computer may need to be restarted to complete the driver install follow onscreen instructions 2 2 3 Proper Care of the BodiTrak Mat e Do notfold the mat e Place the mat gently on surfaces by using the corners e Do notpull on or carry the mat by the USB cable e Do notpivoton the mat e Do not pull on the edges of the mat while itis under a client e Do notpinch the mat between moving components of a support surface e Store the mat flat or in the original packaging roll the mat around the foam core and store in the shipping tube e if your mathas a ferrite installed on the USB cable do not remove it e tis the operator s responsibility to ensure all cables are in good condition inspect all cables for nicks or abrasions prior to each use y lffunction stops during electrostatic discharge to the device reset the system by unplugging from the PC rebooting the PC and plugging in the mat User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 12 User Man
113. op down arrow beside the label in this example Maximum at the top left of the Time Plot field and choose another statistic e The X axis always indicates 10 seconds as described below it can be 5 seconds before and 5 seconds after the currently selected frame or anything in between but at this time the interval will always be 10 seconds This may change in future software releases e The Y axis values and units are dependant on the statistic selected for graphing In the above example the values are from 0 to 200 and in mmHg as this is the currently displayed range and units Adjusting your view range and units in the Legend field will adjust your Y axis values accordingly see I he Legend Display Panel e The vertical bar in the graph indicates the currently selected frame When your cursor hovers over the vertical bar a resizing arrow appears gt Leftclick and drag left or right to adjust what ten second interval is being displayed in the example the plot is from 6 seconds prior to the current frame to 4 seconds after User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 Operating Instructions 51 e f you do not see the vertical bar itis dragged fully to the right or left of the graph Hover your cursor over the right or left border if you see the resize arrow you have found your bar Left click and drag it to the position you want Remember the time plot indicates a 10 second interval if you do not see a graph
114. opposite side with a second finger Repeat until all slots are used number of fingers and slots depend on type of jig The Platens slide into the openings on the slots with sensing High pressure jigs require fingers on the top and bottom of the Slots Lower pressure models require fingers on the bottom only Alternate jig assembly High Pressure jig shown 4 5 2 Placement of the Sensing Mat The following instructions are for a manual calibration If you are calibrating with an FSA Autocalibrator follow these instructions to step 4 then see The FSA Autocalibrator for additional setup instructions 1 Find platens mat inflator bag latex or neoprene tubing sohygmomanomelter and air pump including attachments Refer to Contents of the Calibration Jig Box for visuals 2 Attach latex or neoprene tubing to the 2 connectors on the inflator bag User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 Calibration e 3 Layer from bottom to top i Platen ii FSA mat or sensor top up ribbon F SA systems or USB BodiT rak systems cable exiting out the front left typical Confirm top up by the label on the cable or by the logo on the mat logo up FSA mast should be calibrated with the plastic isolation bag removed iii Inflator bag latex or neoprene tubing exiting out the front To ensure all mat sensors receive equal pressure confirm inflator bag is centered over the mat The inflator bag should rest on the mat w
115. ory affairs only EMERGO EUROPE Molenstraat 15 2013 BH The Hague The Netherlands Phone 31 70 345 8570 Fax 31 70 346 7299 User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 4 User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 1 1 4 System Requirements FSA4 1 software requires the following to operate Supported Operating Systems APC running Windows XP or later operating systems with current service packs Minimum Hardware Requirements 10 MB of free hard drive space 128 MB RAM or minimum required for operating system in use whichever is greater Display capable of High Color 16 bit 800x600 resolution CD ROM drive if using an FSA Type 4 or 5 5E system AUSB port 2 required if using an FSA AutoCalibrator or 2 or more BodiT rak system mats or FSA system Interface Modules ata time Recommended APC running the Windows 7 operating system 2 GB RAM or minimum required for operating system in use whichever is greater Minimum 768 vertical resolution For video If you plan on using the video feature we strongly recommend running Windows 7 with a minimum of 4 GB of RAM Camera must have VFW Video For Windows or WIA Windows Image Acquisition compatibility Please check the driver and operating system compatibility specifications for cameras you are considering purchasing for use with the FSA software or contact technical support at techsupport vista medical com for suggestions lf yo
116. ossible damage to the interface module use only the Vista Medical supplied power supply provided with the system refer to safety notices indicated below e Disconnect the battery pack from the module if not in use for an extended period e The Type Sand 5E Interface Modules operate on power supplied by the computer via the ferrited USB cable provided with the system Use only the Vista Medical supplied USB cable provided with your T ype 5 and 5E Interface Modules e Do not remove the ferrites on the USB cable 2 or the sensing mat cable 1 supplied with your T ype 5 5E Interface Module and mat e f module function stops during use reset the module by disconnecting then reconnecting the power source from the device e We recommend the use of a suitable surge protector with the FSAinterface module as would be appropriate with any computer and or computer peripheral e Type 4 Interface Module only plug the mat s ribbon cable securely into the interface module be sure to keep the connector straight when inserting and removing so as not to bend the pins e tis the operator s responsibility to ensure all cables are in good condition inspect all cables for nicks or abrasions prior to each use e To clean disconnect the module from the power supply Wipe the exterior of the interface module with a soft cloth User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 20 User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 dam
117. ownload when complete the green LED will return to solid 4 To begin another remote session start again at Remote Setup step 1 Power cycle your module by dis and re connecting the power to return it to normal operation You may have to close and re launch your software Download __ Cancel Each time the interface module is triggered on off the final frame collected will be marked as a Key frame look for the gold star in your status bar separating remote recording sequences This allows the FSAuser to correlate an activity with a FSAread s lf your download does not start or you get an error message when attempting to download shut your FSA software down and start it up again User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 Operating Instructions 55 3 7 Adding Video To turn the camera video function on or off 1 Go to Tools System Settings FSA System Settings Your camera should appear in the hardware tree If it aB System sock ee does not make sure it is connected to the computer and MB U71010 4372 200mmhad GH Logitech QuickCam Chat Quality Logitech QuickCam Chat is properly installed 2 Click on the Use Camera if available check box to select or deselect the function 3 Click OK Stop the Scan R2 or Record F3 function if running before going to Tools System Settings to turn your camera on or off Note FSA systems System Settings window shown BodiTrak camera options similar see
118. pened with water Do not use liquid or aerosol cleaners which may contain flammable substances lf function stops during electrostatic discharge to the device reset the system by unplugging from the PC k A rebooting the PC and plugging in the module 2 3 8 Cleaning the FSA Mat FSA mats are typically covered in Polyurethane coated ripstop Nylon 10 mil Polyurethane or Polyurethane coated Nylon Lycra stretch fabric We recommend you use the isolation bags provided with your system at all times to protect against incontinence as well as torque and shear forces The following applies to any of our listed typical coverings e For daily cleaning we recommend wiping down with a damp not wet cloth using a mild soap and water solution e Mild alcohol based cleaners and cleaners containing no more than 10 bleach in non wetting amounts may also be used e Other cleaners disinfectants sold under the following names may also be used Viraguard Cavicide Vitre Tb SeptF x e Undiluted bleach and Hydrogen Peroxide are not recommended e Cleaning products or disinfectants must be thoroughly wiped off after use Allow mat to dry thoroughly before use or e storage Isolation bags are intended for single use only dispose of them according to your institution s biological waste disposal guidelines User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 Getting Started 21 2 4 Calibration Equipment Calibration apparatus is typical to BodiT ra
119. play Panel lise Sa Oe The default Statistics panel When you collect data values will appear aligned to ie ala the right of the panel in black When you select a sub section of the mat see Arithmetic mean mmHg ere aa Statistics Selectable Areas the statistics from the selected area will appear in blue which corresponds to the colour of the outline of the selected area a third section will appear in another contrasting colour and so on id Adjust the size of the statistics panel by left mouse clicking on and dragging the splitters the dotted ee lines dividing it from adjacent display sections For more detail on this procedure see The Surface apat o Plot and Contour Plot Displays You can opt to display or hide any display section by clicking on the Coefficient of variation arrow in the center of the splitters Horizontal center Vertical center Sensing ares Customize the order in which your statistical data displays by clicking on the down arrow to the left Regional cistrbution ofthe statistic which brings up a drop down menu example left and selecting another statistic 3 9 8 The Time Plot Display v Maximum 00 The time plot field will provide you with a graph of the selected mmHg statistic over a 10 second interval the example shown is a graph 0 of the Maximum pressure statistic over a 10 second interval in the 5 4 3 2 1 secs 1 2 3 4 FSA file selected e To select a different statistic click on the dr
120. r save an FSA fsa file as a Template to achieve this refer to Templates Also see Menu Bar File Save P i The New button Starts a new FSA file The templates tab will NOT open using the toolbar button if you want to access the templates use File New or click on the drop down arrow to the right of the New button as shown below To create a new document select a template or sensor amay and then click OK Templates Sensor amays H Bed amp Test Template a InShoe 25cm Example left indicates templates that may be available ga Otho Test in your software Clients can create their own custom amp Seat and Back gi Seat templates see T emplates A Shear select the kind of document you will be making mat type you are using or FSA systems only click the Sensor Arrays tab and select the serial number of the mat you are using then click OK OR Bed Bed cart Click on the dropdown arrow to the right of the New button This will bring up a textual representation POS CMecic Seat left of the Templates tab You may select your type of document mat type here Shoe NOTE To DELETE a Tab select the tab and select File Delete Tab Shoes User Manual for Bodi Trak and FSA Systems 1st Edition Rev 0 Operating Instructions 39 Initiates the Print function also see Menu Bar File Print 5 Copies the selected text or FSA frame from the FSA software to the Windows clipboard Also see Menu Bar Edit Copy T
121. r BodiTrak and FSA Systems 1st Edition Rev 0 Table 4 Requirements The equipmentis intended for use in the electromagnetic environment specified below The customer or the user of the equipment should assure thatitis used in such an environment IEC 60601 test level Portable and mobile RF communications equipment should be used no Conducted RF IEC 3 Vrms closer to any partof the equipment including cables than the 61000 4 6 150 kHz to 80 MHz recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance 35 g Ei IP 80 MHz to 800 MHz T d WP 800 MHz to 2 5 GHz El 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 meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb Interference may occur in the vicinity of known RF transmitting devices and equipment marked with the following symbol Radiated RF IEC 3 V m80 MHz to 2 5 61000 4 3 GHz o NOTE 1 At80 MHz and 800 MHz 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 a Field strengths from fixed transmitters such as
122. r section Assembly of the Calibration Jig and Placement of the Sensing Mat 2 Connect your FSAinterface module FSA systems or BodiT rak mat to your computer as you would normally set up to collect data 3 From your FSA Menu Bar select Tools Calibration Wizard The FSA Calibration Wizard will appear and step you through the calibration Welcome ta the FSA Calibration Wizard This wizard will guide you through a calibration procedure The calibration process i Used to ensure the accuracy of the sensor readings To use this wizard it s important to have some understanding of the calibration process Please read the Calibration section o Click Next to continue of your User Manual before proceeding FSA Calibration Wizard Sensor Array Please select the sensor array that vou want to calibrate Select the sensor array vou want to calibrate and a calibration technique then click Hest e FSAsystems only Select the mat you wish to Sensor array UT1010 7014 200nmmhod v calibrate from the Sensor array drop down TEPE OAC E BodiT rak systems start at next step O Applied weight e Choose the technique you wish to calibrate with Use the pressunzed inflator bag technique followed by an applied weight calibration to Click Next completely recalibrate your mat Use the applied weight technique routinely to maintain accurate readings between complete calibrations Which technique you select governs the options avail
123. red The Video options lf you have a camera connected to your computer e Selector de select Use camera when available e Select your camera if more than one is connected to your computer e Select image quality Better quality larger FSA files sensor Arrays e View the BodiT rak mat s currently connected to your computer ABodiT rak system BT 1510 16x16 seat mat can read up to 50 Hz The FSAsystem s computer interface module can read up to approximately 10 000 sensors per second when set to High Speed see I ools System Settings half of that when High Speed is not selected Atypical 16x16 256 sensor mat can read up to approximately 40 Hz with High Speed selected 10 000 256 sensors 39 Hz To convert Hz reads per second into seconds per read invert the number e g 0 5Hz 0 5 reads per second 1 0 5 2 seconds per reading e g 0 1Hz 0 1 reads per second 1 0 1 10 seconds per reading User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 Operating Instructions 35 To convert Hz readings per second into readings per minute multiply by 60 eg 0 5 Hz 0 5 x 60 30 readings per minute eg 0 01 Hz 0 01 x 60 0 6 readings per minute 10 readings per second 10Hz 1 reading per second 1Hz 1 reading every 10 seconds 0 1Hz 1 reading every 20 minutes 0 05Hz 1 reading every 30 seconds 0 0333Hz 1 reading minute 0 016 7Hz 1 reading every 10 Minutes 0 0017Hz 1 reading every 30 minu
124. released between 1998 and 2000 User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 Optional Accessories 71 5 3 Custom Sensors and Mats Mats beginning with the UT 5010 ST 5010 or BodiT rak BT 5010 prefix are custom and may require unique set up use and calibration instructions that are not covered in this user s manual Please refer to the documentation that shipped on the CD or USB Flash drive with your sensor Rectangular custom mats are typically calibrated as instructed in the Calibration section All BodiT rak mats have only 1 calibration per mat the following does not apply FSAsystem mats sensors typically have one and only one Sensor Array file containing one calibrated range This is not always the case with UT5010 ST 5010 Custom mats which may have multiple calibrated ranges depending on what the customer requested You may not receive one Sensor Array file per range the different calibrations are a part of your mat s Sensor Array file To select a different calibration range on a multi range calibrated mat with a single Sensor Array file With your mat s Sensor Array file selected check the FSA status bar for your serial number 1 Goto Tools System Settings 2 Leftclick on the mat icon 3 Leftclick on the radio button below the line Always use the newest Calibration This will enable the calibration selection dropdown 4 Select another calibration range from the dropdown 5 Click OK 6 Check the FSAle
125. ropdown on the right if not determined earlier or select the Port number found under Device Manager earlier 4 Click the Upload Firmware button The Upload Firmware Wizard will start 5 Follow the Wizard selecting the options that applies to your situation clicking Next when prompted 6 Power cycle your module after the process has completed by dis and reconnecting power to the module After the power cycle the green LED should be illuminated NOTE If using a USB capable Interface Module any of the Modules with a serial number containing a U or T do not perform an Upload Firmware unless running FSA4 0 release 199 or up If this has already occurred and you cannot Clear the yellow light upgrade your FSA4 0 software from www pressuremapping com and repeat including dis and User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 36 User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 reconnecting the power to re set the device If you cannot clear the yellow light please contact technical support at techsupport uista medical com You may have to send your Interface Module in for reprogramming Configure Select the interface module type and connected port Initialize EA Prepare the interface module to accept new firmware Select the interface module type and it s port then click Next Unplug the USB cable from the interface module Press the button on the interface module and while
126. s 1st Edition Rev 0 2 3 1 Component Description of FSA Type 4 System Shipping Tube with Shipping Foam your typical FSA system will arrive with the sensing mat wrapped around the foam core and the interface module and other accessories inside the foam Save the tube and foam for storage or transportation of your FSA system Typical FSA Mats are covered in a polyurethane coated ripstop nylon or Nylon Lycra fabric The mats have an attached ribbon cable covered with a black nylon braided cable sleeve and a 34 pin plug the cable also gives the serial number and orientation top bottom of the mat The Nylon covering the FSA matis blue on one side and black on the other For easy orientation blue is on top For purposes of good hygiene to protect against tension and incontinence and to increase durability of the mat ALWAYS use the FSA Sensor mat with an isolation bag The Type 4 Interface Module face has two 34 pin receptacles A and B for the ribbon cable from the FSA mat s and three LED lights The rear of the interface module contains a single pin receptacle for the battery pack or the Interface Power Supply an 8 wire receptacle similar to the common telephone jack in North America and a USB B port Use only the Interface Power Supply or battery pack supplied with your FSA system with your interface module For the Type 5 and 5E Interface Module and mat system refer to Contents of the Shipping Tube Type 5 or 5E System FSA USB C
127. t e BodiT rak mats are typically covered with a polyurethane coated Nyion Lycra stretch fabric e Your BodiT rak mat connects to the computer via the USB cable permanently connected to it e BodiT rak software allows the user to scan record annotate file and share the information gathered by the sensors BodiTrak systems are run on powered by FSA 4 1 and up software 2 2 1 Component Description of BodiTrak System Shipping Tube with Shipping Foam your typical BodiTrak system will arrive with the sensing mat wrapped around the foam core Save the tube and foam for storage or transportation of your BodiTrak system Typical BodiTrak mats are covered in a polyurethane coated Nylon Lycra fabric and have an attached USB cable The label on the cable contains the model and serial number of the mat For easy orientation the logo is on the top side of the mat Additional FSA Software USB Flash Drive including an electronic user s manual Hard copy Manuals are only included if required by your jurisdiction User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 Getting Started 11 2 2 2 Hardware Setup for BodiTrak System Plug the BodiT rak mat s USB cable s securely into an available USB port on your computer You should hear a Windows device connect tone if you don t dis and reconnect until you do or try another USB port Wait for Windows to tell you the driver has been successfully installed watch the Windows notificati
128. t such as Microsoft Word image Microsoft Excel data or an image editor Please refer to the section Exporting Data for how to export FSA data outside of FSA The Editing Context Menu The editing actions Undo Cut Copy and Paste plus Select All are available from a context menu if your focus is on the Client Information tab or Note Area right mouse click to pull up the menu User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 Operating Instructions 27 3 3 3 View armel Mews View Normal View and View Comparison View Left mouse clicking on one or the other switches between the views Left click on Comparison View to view four FSA frames from your current FSA file A check mark indicates which Comparison View Document Bar view is selected Navigation Bar Status Bar View Document Bar Left mouse clicking on Document Bar toggles the Document T oolbar New Open Save Print Cut Copy Paste Scan and Record on and off a check mark indicates the feature is on View Navigation Bar Left mouse clicking on Navigation Bar Skip Backward Rewind Play Fast Forward Skip Forward toggles the Navigation Bar on and off a check mark indicates the feature is on View Status Bar Left mouse clicking on Status Bar bottom of FSA Window with System Status Key and Selected frame indicators Frame Counter Date and Time toggles the Status Bar on and off a check mark indicates the feature is on 3 3 4 Action A
129. t this statistic ignores the Statistics Minimum and includes all the sensor readings when calculating their value User Manual for Bodi Trak and FSA Systems 1st Edition Rev 0 Operating Instructions 59 3 11 6 Regional Distribution Indicates what percentage of the total load is in each selected region If there is no sub region selected this will always be 100 entire mat see Selectable Areas User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 eo User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 3 11 7 Selectable Areas With FSA 4 you can gather statistics for a selectable area of the sensing array By default statistics indicated in the Statistics display are for the entire array To select a section of the array left click on a cell and drag the cursor over the area you want to isolate the statistics from The statistics field will now display data from your selected cells The text in the Statistics panel will be the same colour as your selected area s outline To select subsequent areas e Hold down the CTRL button on your keyboard left click on a cell and drag the cursor over another area e LOCK your selected area s by right clicking over the Contour Plot and selecting Lock Regions from the context menu that appears e To unlock repeat and select Unlock Regions Note that the locked region s setting is saved in your FSA file if you unintentionally click in the array when you want to se
130. t whose readings are at or above the Statistics minimum lf the bottom end of your scale look to your Legend display is 0 the software will show the area as the full area of the mat as 0 would be considered as part of the loaded area A a cell showing a numerical value of 0 mayin fact have a load applied of less than 1 if you hold your mouse pointer over a cell displayed as 0 you may see that as you see the values to one decimal place in the tool tip To omit lower values from the statistics you can raise the bottom of the display range by clicking on the corresponding arrow in the Legend 3 11 9 Standard Deviation units The square root of the variance The comparison of standard deviations for samples with different means is not informative even if absolute magnitudes of the deviation are equal the degree of variability relative to each average pressure could be different 3 11 10 Statistics Minimum The Statistics Minimum is the minimum sensor reading that will be included in all statistics calculations excepting Minimum and Maximum and is equal to the display minimum Statistics are calculated with sensor readings that are greater than or equal to the Legend s minimum Raising the Legend s minimum refer to Display Range Values thus changes the statistics minimum 3 11 11 Variance units Ameasure of the variability or dispersion of individual sensor values around the average pressure value Calculated as th
131. tatement The Federal Communications Commission in 47 CFR 15 105 has specified that the follow ing notice be brought to the attention of the users of this product This equipment has been tested and found to comply with the limits fora Class A digital device pursuant to Part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instruction manual may cause harmful interference to radio communications Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense The end user of this product should be aware that any changes or modifications made to this equipment without the approval of Vista Medical could result in the product not meeting the Class A limits in which case the FCC could void the user s authority to operate the equipment This device complies with Part 15 of the FCC Rules Operation is subject to the following two conditions 1 this device may not cause harmful interference and 2 this device must accept any interference received including interference that may cause undesired operation Industry Canada compliance statement This Class A digital apparatus complies with Canadian I
132. tem Settings To convert Hz reads per second into seconds per read invert the number e g 0 5Hz 0 5 reads per second 1 0 5 2 seconds per reading e g 0 1Hz 0 1 reads per second 1 0 1 10 seconds per reading To convert Hz readings per second into readings per minute multiply by 60 eg 0 5 Hz 0 5 x 60 30 readings per minute eg 0 01 Hz 0 01 x 60 0 6 readings per minute 10 readings per second 10Hz 1 reading per second 1Hz 1 reading every 10 seconds 0 1Hz 1 reading every 20 seconds 0 05Hz 1 reading every 30 seconds 0 0333Hz 1 reading per minute 0 0167Hz 1 reading every 10 minutes 0 0017Hz 1 reading every 30 minutes 0 0006Hz User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 1 reading per hour 0 0003Hz My Scan and Record buttons are greyed out cannot collect any data or I am getting a Not ready message in my status bar Either you do not have a sensor array cal file loaded for the template currently selected you have the wrong template selected or your software is not looking for your sensor array cal files in the correct directory To resolve Locate the CD that came with your FSA mat and install the sensor array file following the instructions on the CD label If you cannot locate it contact technical support indicating your serial number and we can provide the factory calibration file via return e
133. tes 0 0006Hz 1 reading per hour 0 0003Hz Notes High Speed mode should be deselected when using a dual mat set up For both BodiTrak and FSA systems actual speed varies due to ceilings imposed by the computer itself and varies slightly computer to computer Actual speeds will vary mat style to mat style computers typically cannot process fast enough to accommodate mats with a low number of sensors to 10 000 sensors per second 3 3 5 7 Upload Firmware FSA Systems You may need to Upload Firmware to your interface module after a software upgrade or if your Interface Module s programming becomes scrambled If you see a solid yellow light on your module which neither restarting your computer or power cycling your Interface Module clears you should do an Upload Firmware This action will upload data to your FSA Interface Module from the FSA software Make sure your Interface Module is connected to your computer and powered up 1 Start your FSA software and allow the software to autodetect the module Try test scanning to make sure the computer is communicating with the Interface Module if you can or go to Windows Start Control Panel System Hardware Device Manager to determine what COM port Windows has assigned your module Look for USB serial Port under Ports COM amp LPT 2 Goto Tools System Settings click on the Interface Module icon in the device tree on the left 3 Note the COM port your Interface Module is on from the Port d
134. the FSA software and places it onto the CUS Windows clipboard keyboard shortcut Ctrl X also see the FSA Document File Edit View Action Tools Help Copy Select Current Bar on iS N Edit Copy Copies the selected text from the Note Area or the Client ET T aae Information tab or FSA frames from the FSA software to the Windows i clipboard keyboard shortcut CT RL C also see the FSA Document Bar Edit Paste Pastes the contents of the Windows Clipboard into FSA keyboard shortcut CTRL V also see the FSA Document Bar e Textual data may be pasted into the Note Area or Client Information areas only e FSAFrames will be appended to the end of the currently open FSA file Edit Select Selects frames in the currently open FSArecording per the User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 parameters indicated under Edit Invert Selection below il MIM Pe TSA FSA File Edit View Action Tools Help Irs k aG grem d ut Ctrl BES copy Ctrl SS uoa Edit Deselect De selects frames in the currently open FSA recording per Select e the parameters indicated under Edit Invert Selection below Deselect d Current Invert Selection F All Ctrl ShiFt 7 Forward Ctriv Backward CH Y Fol ampe Tsa FIA Edit Invert Selection Inverts the selection state per the parameters below Current The currently displayed FSA fr
135. the feature before or the last print settings used To preview your printed report select File Print Preview from your FSA Menu Bar To customize the report FSA Page Setup Ax Format Faper 1 Goto File Page Setup The FSA page Setup dialog appears Layout Template right 2 Selecta report style from the Layout T emplate drop down Hall Page Width Note Beside Reading OF E dropdown is open in example 3 Choose to include All Selected or Current frames 4 Selecta font style and size Name 5 Choose to include Client Information and or Page numbers Size fo Zae 6 Click the Paper tab to choose paper size and source Margin size and orientation these options are also available directly ee g Client information Page numbers from File Print Properties 7 Click OK HINT Do a Print Preview to make sure your report is what you want before initiating the print Clicking the Print button in your toolbar or selecting File Print from the FSA Menu bar or CT RL P will bring up your Windows Print dialog box In this window you can choose the printer you wish to use the number of copies you wish to make and the pages you want to print all pages or a selection Clicking the Properties button allows the user to make changes to the printer properties some of the options offered are dependant on the printer you have installed and selected User Manual for BodiTrak and FSA Systems 1st Editio
136. u plan on using video pay attention to the minimum system requirements for your camera NOTES The system may not work through a laptop docking station Make sure your computer has its own USB ports FSA systems only The final FSA4 0 software release tested on Windows 2000 SP4 is FSA4 0 225 Microsoft is discontinuing support of Windows 2000 SP4 in July 2010 FSAsystem T ype 4 Interface Modules will run through a serial port but as of November 1 2009 serial cables are no longer supplied with the FSAsystem The cables are still available for purchase please contact your distributor if you require one 1 1 5 Operator Requirements No special skills training or knowledge are required for operation aside from the information included in this instruction manual For location of use restrictions refer to the section Product Environmental Specifications User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 Introduction 5 1 1 6 Operator and Patient Positioning The expected positions of the patient and operator are the patient sitting laying or standing on the pressure mat and the operator viewing the computer monitor 1 1 7 Intended Use The intended use of the pressure sensing mat is to discern the relative pressure levels of a mass on a support surface 1 1 8 Models Covered by This User Manual This User Manual applies to the following models BodiT rak Systems BT 1510 BT 1526 BT3510 BT3520 B U T3526 BT4
137. ual for BodiTrak and FSA Systems 1st Edition Rev 0 2 2 4 Cleaning the BodiTrak Mat BodiT rak mats are typically covered in Polyurethane coated Nylon Lycra stretch fabric For daily cleaning we recommend wiping down with a damp not wet cloth using a mild soap and water solution Mild alcohol based cleaners and cleaners containing no more than 10 bleach in non wetting amounts may also be used Other cleaners disinfectants sold under the following names may also be used Viraguard Cavicide Vitre Tb SeptFx Undiluted bleach and Hydrogen Peroxide are not recommended Cleaning products or disinfectants must be thoroughly wiped off after use Allow mat to dry thoroughly before use or storage User Manual for Bodi Trak and FSA Systems 1st Edition Rev 0 Getting Started 13 2 3 FSA Systems Components of an FSA System Your FSA system consists of one or more sensing mats pressure or otherwise an interface module cables computer software and often a manual calibration kit e FSA mats are typically covered with a polyurethane coated Ripstop Nylon or Nylon Lycra stretch fabric or Polyurethane e Your FSA mat connects to the computer through the Interface Module and USB cable included with the system e FSAsoftware allows the user to scan record annotate file and share the information gathered by the sensors User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 14 User Manual for BodiTrak and FSA System
138. uared end into the back of the interface module The green light will illuminate and you should hear a Windows Device Connect beep You have completed connecting your T ype 5 or 5E Interface Module The remaining instructions apply to the T ype 4 Interface Module only 5 Plug the Interface Power Supply into a power source If connected properly the green light on the interface module will illuminate indicating the interface module is receiving power You should hear a Windows Device Connect beep 6 Find the FSAmat Plug the mat s ribbon cable securely into receptacle Aof the interface module Use receptacle B for a second FSA maf s ribbon cable Be sure to keep the connector straight when inserting and removing so as not to bend the pins lf the green light is not illuminated does the power source work Is the Interface Power Supply secure On some laptops the lights will not illuminate until a scan or record is initiated If initiating a scan does not illuminate the lights please refer to the section Frequently Asked Questions When you connect and disconnect a USB device you should hear a tone from your computer Wait to hear that tone before scanning To avoid communication errors try to connect your FSA Interface Module to the same USB port on your computer every time you run the FSA system User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 Getting Started EA 2 3 4 Hardware Setup Serial FSA Systems Connectin
139. ues minimum from the statistics calculations and the contour and surface plot displays ie sensors with a value of 0 Also see Statistics Minimum and Display Range Values Hide Centers ane regarding adjusting the range of values Show Gradients Exclude Minimum For Lock Regions Unlock Regions refer to Selectable Areas Show Splitters You can toggle the display of the Center of Pressure marker a small white circle on or off by toggling between Show Centers and Hide Centers When this option is selected and the Record function engaged the track of the center of pressure over time will appear as a black trace for up to 10 seconds of scan time The Center of Pressure appears for 10 seconds of recording time regardless of the scan frequency 5Hz 5 readings per second will give you 50 frames of trace 30 Hz should give you 300 Adjust Scan frequency under Tools System Settings Center Marker User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 44 User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 3 5 1 Comparison View Client Information Tuesday March 31 2009 aah EE lg OE Te Aar T iN TEZEJ 157 Bo of Ba J k ES AA Pi hk 13 l l Tor fai Th arj m I m es m n el i Hu EREASRe is ipa i a Pa mai Gen ard Oe ee S LEi de La tania n Ameria erst ee i 2b SEARS oo reg gt wee dor TE ees SL ee i hir hL 708 para om The Comparison View a
140. ycra fabric The mats have an attached ribbon cable covered with a black nylon braided cable sleeve and are permanently connected to your FSA Type 5 Interface Module 5E systems do not have the mat permanently attached the cable also gives the serial number and orientation top bottom of the mat The Nylon covering the FSA matis blue on one side and black on the other For easy orientation blue is on top For purposes of good hygiene to protect against tension and incontinence and to increase durability of the mat ALWAYS use the FSA Sensor mat with an isolation bag The Type 5 or 5E Interface Module has three LED lights and a trigger button on the face The rear of the interface module contains a single pin receptacle for power which is not used at this tme and a USB B port Type 5 and 5E Interface Modules are powered by your computer via the part LI USB cable supplied with your FSA system a power supply is not required even though there is a power receptacle on the rear of the module This receptacle is for future use For the Type 4 Interface Module systems refer to Contents of the Shipping Tube Type 4 System Accessories FSA Cable One LI USB A B cable 6 feet in length which connects the interface module to the computer via USB port FSA Software CD including an electronic user s manual plus a FSA sensor array file CD iftwo or more mats purchased Hard copy Manuals are only included if required by your jurisdiction Isol
141. ystem through the USB port you installed to Windows Vista Windows 7 similar 1 Connect your FSA USB AB cable to an available USB port on your computer 2 Connect your FSAUSB AB cable to your FSA Interface Module or FSAUSB Autocalibrator 3 Connect your ACCHHHH or ACC70 power supply if installing an FSAUSB Autocalibrator to your interface module or Autocalibrator and to a power source 4 A Found New Hardware window will appear with the message Windows needs to install driver software for your USB amp gt Serial Click the option Locate and install driver software recommended 5 A User Account Control window Stating Windows needs your permission to continue will appear Select Continue 6 a lf your computer is connected to the internet Windows will go to the Windows Update site to locate the suitable drivers Go to step 7 b If your computer is not connected to the internet you will be prompted to Insert the disk that came with your USB serial Converter Insert your FSA 4 0 Software CD now Go to step 7 c If you are installing the drivers from other media downloaded from our web site to your computer a USB thumb User Manual for BodiTrak and FSA Systems 1st Edition Rev 0 Getting Started 19 drive or your own CD for example select the option I don t have the disc Show me other options and Select Browse my computer for driver software advanced Use the Browse button t

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