FSA 4.0 Instructions for Use
Contents
1. Innovative Pressure Mapping Solutions FSA 4 0 Instructions for Use Version 4 Rev 3 2012 N24 ANS English VISTA MEDICAL Table of Contents TANIEGO CONO Ce ee ne A ee eee ee 2 FSA 4 0 Instructions for Use Basic Setup and Operations c cccccccccssssssscsecsecsecssssrsessessascsecsecaesersseseessescaecatsansansanseeses 3 1 System adore U1 1 12 e essai ee ee ee ee ee 3 RAAD ETA p pE A tan lagna alte eva ie closed alk a st oa fed E ainda aoa nana aetna 3 1 2 Recommended ee re E Ea 3 Ms OP VIO aE E E E A EEE EA AA AEA 3 Ze SOW E V AT EA EAI AAE EEE AAA AA EA si fase AAE EA E A E 3 ZAM DOW EEAS e E a E EA NOA A A E A A EAE E A A E E N 3 22 FSA SUpport Files Stall HOM snc nnii eienen ENEE EEES 3 HAONA S U er O E A EA 3 3 1 USB Connection Type 4 Type 5 and Type SE Modules cccessescscssssscsscsscsscsssessesessessessesessessessesseseeseesaseateass 3 3 2 Serial Connection Type 4 Modules Only 0 0 ccccecsscsessssscsecsesecsecsecsccessessessesseseeseeceecassesseseeseesaeseesaesassesseseeseesaeean 4 AL UPON ite ETA LU etal eertce tests erica E E EAEE inde eb me E E E E EE R 4 SAN E Ro AU D DAVE e E E E E eden tbotescessecdie deca 4 BEIE ONI EO aO e E A E EE 4 feo prao Vni IUO aeae E E A E E EA EE E AE N EAE 5 6 Acceptable calibration Valles isi acccvetvccnssisnataneslncosie n Ea T Ea E OTa E 5 PO CNG E A N AE AE E E A E E E E E AA E E A 5 OR 6 0 0 ea A eee 5 MO PROB SR Cae C FOA MAIS ionnann hectare to esos ac E2. 3m Interface Power Supply 9V Universal Medical Grade Power Supply Manufactured by Model WM10 9V 1 PowDec Technologies Input 100 240VAC 50 60Hz 0 4A Output 9VDC 1000mA 7013 Realm Drive Suite E Output Connector 5 5x2 1x12mm San Jose CA 95119 USA Approvals CSA 22 2 No 601 UL60601 TUV EN60601 CE Mark LVD Battery Pack 9V Manufactured by Priority Electronics Ltd 55 Trottier Bay Winnipeg MB Canada R3T 3R3 ireless Type 5 Battery Pack open Manufactured by Priority Electronics Ltd 55 Trottier Bay innipeg MB Canada R3T 3R3 ireless Type 5 Battery Pack closed Manufactured by Priority Electronics Ltd 55 Trottier Bay Winnipeg MB Canada R3T 3R3 9V Battery 6 1 8m FSA Serial Cable type4 Max Tength 1073 ax length 10 3m ax length 10 3m ax length 10 3m ACC018 ACC024 Type 5 5E Wireless Kit 1 L124 Interface Module Type 5 Wireless LI26 Interface Module Type 5E Wireless 1 LI141 SD1000 Bluetooth Serial Adaptor with 1 dBi stub antenna 1 LI142 UD100 Bluetooth USB Adaptor with 1 dBi stub antenna 1 L13C 9 23cm Parani Cable Type 5 1 FSA1056 9V Battery Pack and Battery Instructions Also includes 1 LI62 1 8m 6 USB Cable with ferrites for wired use ype 4 Wireless Kit 1 LI141 SD1000 Bluetooth Serial Adaptor with 1 dBi stub antenna 1 LI1142 UD100 Bluetooth USB Adaptor with 1 dBi stub antenna 1 LI121 12 30cm Parani Cable Type 4 1 FSA1056 9V Battery Pack and Battery Instructions WARNING Use o
3. FSA4 Instructions for Use ENGLISH A4 ver 4 rev 3 doc 7 12 4 IEC 60601 1 2 2004 Ed 2 1 This product has been tested and found to comply to IEC 60601 1 2 2004 Ed 2 1 for electromagnetic compatibility EMC as a Class A product 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 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 TV 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 2004 Ed 2 1 5 This equipment should not b
4. Manitoba Canada R3Y 1G4 Phone 1 204 949 7661 North America Toll Free Technical Support 800 847 3157 E mail techsupport vista medical com web www pressuremapping com Outside of North America Please contact your distributor A listing of our worldwide distributors can be found online at www pressuremapping com look for the Contact link EC Representative regulatory affairs only Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Phone 31 70 345 8570 Fax 31 70 346 7299 12 Safety amp Electronic Emissions Notices 12 1 CAN CSA C22 2 601 1 M90 UL 60601 1 and EN60601 1 This product has 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 Medical Device Type Class with measurement function Degree of protection against electric shock Type B Applied Part Degree of protection against ingress of water IPX0 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 Mode of operation Continuous Environmental Operating Conditions 10 40 C 30 75 rH non condensing 700 1060hPa 12 2 Federal Communications Commission FCC statement The Federal Communications Commission in 47 CFR 15 105 has specified that the foll
5. the mat from incontinence torque and shear forces by using the isolation bags provided Place the mat gently on surfaces by using the corners Do not pull on or carry the mat by the ribbon cable Do not pivot on the mat Donot pull on the edges of the mat while it is under a client Do not pinch the mat between moving components of a support surface Store the mat flat or in the original packaging roll the mat around the foam core and store in the shipping tube The Nylon or Nylon Lycra 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 10 2 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 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 FSA4 Instructions for Use ENGLI
6. EE i EEE ETRAS 5 TCI eE aS MA E EA EE ET EE AAEE EA E E A 5 10 3 Proper Care of the IMLS ACS Modules o csinssccsncsactesecasnacinsianstnsdadsaleatiedbusnnandadiosedassindnsyealnitdpvisntusibadeesteiaiintnadnateideieewetes 6 TL User Assistance Normat csisnocctisne ete yeiatistienan ncpeicacean A a T 12 Safety amp Electronic Emissions Notices ccccccceccssssssesssssessssssecseeseeseesecessessssseseeseeseesesoeseeseesasseesensessesaesersrsenseesenaess T 12 1 CAN CSA C22 2 601 1 M90 UL 60601 1 and EN60601 1 uu eee ccecsecsesseeseesesssccsecsecsessessesseseesseecsecatsansensenses 7 13 Product Environmental Specifications ccccccccscssssssscsscsecssssrsssssssssscsscsecsesseseeseessuseascaecaesaeseeseeseessascassaseaseaesatsansanseess 11 14 Approved Parts and Accessories seicssinsssiansaessannsietonhanniivsiaieswiscuntorsreqempuint jeontniasodbannsuentbning nylon ieokinisaotai ensibiaoiensthashieautinantiven 12 1 DEION Ole VOOS ros nE E E TE E E EAEE 13 FSA4 Instructions for Use ENGLISH A4 ver 4 rev 3 doc 2 FSA 4 0 Instructions for Use Basic Setup and Operations 1 System Requirements 1 1 Minimum A PC running the Windows XP Windows Vista or Windows 7 32 bit operating systems with current service packs 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 A USB port 2 required if usin
7. SH A4 ver 4 rev 3 doc 5 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 Isolation bags are intended for single use only dispose of them according to your institution s biological waste disposal guidelines 10 3 Proper Care of the Interface Modules Do not drop the interface modules There are no user serviceable parts in the interface modules do not open them Protect the interface modules from exposure to moisture Store the interface modules in a location where it is protected from falling or in the original packaging inside of the foam core and store in the shipping tube The Type 4 Interface Module operates on 9V AC or battery power To protect against possible damage to the interface module only use the power supply provided with the system refer to safety notices indicated below Disconnect the battery pack from the module if not in use for an extended period The Type 5 and 5E Interface Modules operates on power supplied by the computer via the L162 ferrited USB cable provided with the system Use only the USB cable provided with your Type 5 5E Interface Module Donot remove the ferrites on the LI61USB cable 2 or the sensing mat cable 1 supplied with your Type 5 5E Interface Module and mat If module function stops during use reset the module by disconnecting
8. according to the maximum output power of the communications equipment Separation distance according 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 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 W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 13 Product Environmental Specifications Storage 40 to 70 C Operating 30 to 75 RH non condensing Storage 10 to 100 RH non condensing Atmospheric pressure Operating 700 to 1060 hPa Storage 500 to 1060 hPa FSA4 Instructions for Use ENGLISH A4 ver 4 rev 3 doc 1 1 14 Approved Parts and Accessories Part Description ther LI2 Interface Module Type 4 9V DC 500 mA Eoo Module Type 5 5V DC 250 mA via USB i Module Type 5E 5V DC 250 mA via USB 2 mereoeModueWreessTypes O OOOO S Li26 nterface Module Wireless Type Se i ACC2010 European Schuko Cord Set 8 2 5m Max length 10 3m UKCordSet 8 2 5m Max length 10
9. by absorption and reflection from structures objects and people NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the 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 1 V m FSA4 Instructions for Use ENGLISH A4 ver 4 rev 3 doc 1 0 IEC 60601 1 2 2004 Ed 2 1 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
10. cated matches the serial number of the mat you have plugged into your interface module you should be ready to collect data Go to step 4 below If your FSA Status Bar does not display a serial number either i Your Sensor Array files are not installed or not installed where they should be please review section 2 2 FSA Support Files Installation ii The template selected in step 1 above does not correspond to the style of mat you own Please verify what style of mat you own example Seat Bed 4 Click the Client Information tab to enter information that applies to this client file as a whole 5 Click on the Recording tab the title on the tab is dependant on the Template selected in step 2 6 Left mouse click either the Scan or Record buttons in the FSA4 Toolbar to start collecting data Scan collects data one frame at a time click Scan once to start scanning click Scan again to stop The last image will be kept Repeat as required Record collects data continuously until you click Record again to stop FSA4 Instructions for Use ENGLISH A4 ver 4 rev 3 doc 4 7 When the Scan or Record functions are disengaged left mouse click in the Note area at the bottom of your FSA window to add frame specific notes if required 8 Go to File Save to save your file 7 Calibration Verification Every FSA mat is calibrated to the appropriate working pressure range Calibration information is stored within t
11. e 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 it is 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 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 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 If in doubt contact qualified technician or your local representative 1 The normal distance of at least 1 5 m from the patient or the patient support shall be provided The FSA product has been certified to comply with 93 42 EEC for the purposes of CE Marking as a Medical Device FSA4 Instructions for Use ENGLISH A4 ver 4 rev 3 doc 8 M TT IEC 60601 1 2 2004 Ed 2 1 Table 201 Requirements The equipment is intended for use in the electromagnetic environment specified below The c
12. f 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 2004 Ed 2 1 FSA4 Instructions for Use ENGLISH A4 ver 4 rev 3 doc 1 2 15 Definition of Symbols lternating current hd et Caution risk of danger or attention consult accompanying document S S fer number mS Model number ER E representative Type 4 Module Start or Stop recording mode Type 5 5E Module User input required as instructed in manual FSA4 Instructions for Use ENGLISH A4 ver 4 rev 3 doc 1 3
13. g a FSA AutoCalibrator or 2 or more Interface Modules at a time 1 2 Recommended A PC running the Windows XP operating system 1 GB RAM or minimum required for operating system in use whichever is greater Display set to 24 or 32 bit with a 1024x768 resolution 1 3 For video Camera must have VFW Video For Windows or WIA Windows Image Acquisition compatibility 2 Software 2 1 Software Installation 1 Insert the FSA Software CD into the CD ROM drive typically D on your computer If the setup does not start automatically Click the Start button 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 2 2 FSA Support Files installation The FSA Support Files CD s must be installed after the FSA Software has been installed If you receive the FSA Software CD only proceed to Hardware Setup Your Sensor Array Template files etc will install with the software If you receive one or more FSA Support Files CD s repeat steps under Software Installation above replacing the FSA Software CD with the FSA Support Files CD 3 Hardware Setup 3 1 USB Connection Type 4 Type 5 and Type 5E Modules 1 Types 4 5 and 5E locate the FSA USB Cable LI 62 Interface Module and Universal Power Supply ACC A power supply i
14. he SensorArray file We recommend following a monthly calibration schedule Increase calibration frequency when conducting research when statistically analyzing pressure values or when numerical pressure values are critical 8 Acceptable Calibration Values When performing validation on calibrations When viewing the verification file to validate the calibration ensure the following criteria 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 At a 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 The Calibration Wizard creates verification for you by default when you calibrate your mat it will be stored in your default FSA Documents directory and the file name will be the serial number of your mat 9 Accuracy FSA pressure mapping sensors are accurate to within 20 over the recommended operating range For more details please refer to sections 7 Calibration Verification and 8 Acceptable Calibration Values 10 Cautions 10 1 Proper Care of FSA Mats Do not fold the mat Keep the mat dry Protect
15. ir Floors should be wood concrete or ceramic tile If 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 Electrical fast 2 kV for power supply 2 kV for power supply transient burst IEC ines 1 KV for ines 1 KV for iis kel E een 61000 4 4 input output lines input output lines P 1 kV line s to line s 1 kV line s to line s Mains power quality should be that of a typical SUTEA BN er 2 kV line s to earth 2 kV line s to oe commercial or hospital environment lt 5 9 gt 95 dip i A Ea L o we rie Voltage dips short UT for 0 5 cycle 40 or es y Mains power quality should be that of a typical a es UT 60 dip in UT for 5 interruptions and UT 60 dip in UT for 5 i a commercial or hospital environment If the user of i i i cycles 70 UT 30 voltage variations on cycles 70 UT 30 coe the equipment requires continued operation a dip in UT for 25 cycles ae da power supply input dip in UT for 25 cycles during power mains interruptions it is No anomalies lines IEC 61000 4 1 1 recommended that the equipment be powered 0 0 in i i UT 230 Vac lt 5 i o 7 in 95 dip meets from an uninterruptible power supply or a battery 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 typica
16. l commercial or hospital environment FSA4 Instructions for Use ENGLISH A4 ver 4 rev 3 doc IEC 60601 1 2 2004 Ed 2 1 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 Immunity test IEC 60601 test level Ee Electromagnetic environment guidance Portable and mobile RF communications equipment should be Conducted RF 3 Vrms used no closer to any part of the equipment including cables IEC 61000 4 6 150 kHz to 80 MHz 1 Vrms than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance 35 d v P Fi 35 m d VP 80 MHz to 800 MHz E e a Radiated RF IEC 3 V m 80 MHz to 2 5 a Le 800 MHz to 2 5 GHz 61000 4 3 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of 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
17. owing 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 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 12 3 Industry Canada compliance statement This Class A digital apparatus complies with Canadian ICES 003 Cet appareil num rique de la classe A est conforme a la norme NMB 003 du Canada
18. s not required with a Type 5 5E Interface Module it is powered by the computer via the USB Cable 2 Types 4 5 and 5E plug the FSA USB cable s USB A the rectangular end securely into an available USB port on your computer Type 4 Module only plug the Interface Power Supply into the back of the interface module 4 Types 4 5 and 5E plug the FSA USB cable s USB B the squared end into the back of the interface module The green LED light will illuminate and blink on the face of the Type 5 5E Module and you should hear a Windows Device Connect beep You have completed connecting your Type 5 5E Interface Module If this is the first time you have connected this module to this USB port the Windows Found New Hardware Wizard will appear in the status bar Wait for the message Your device is ready to use before proceeding to use your FSA system The remaining instructions apply to the Type 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 a FSA4 Instructions for Use ENGLISH A4 ver 4 rev 3 doc 3 TN VIST receiving power You should hear a Windows Device Connect beep If this is the first time you have 7 EDIGAL connected an FSA Type 4 module to this computer the Windows Found New Hardware Wizard will appear in the status bar Wait for the message Your device i
19. s ready to use before proceeding to use your FSA system 6 Find the FSA mat Plug the mat s ribbon cable securely into receptacle A of the interface module if your FSA mat has two connectors connect to Port A and Port B as indicated on connector label Use receptacle B for a second FSA mat s ribbon cable Be sure to keep the connector straight when inserting and removing So as not to bend the pins 3 2 Serial Connection Type 4 Modules Only 1 Locate the 6 Serial FSA Cable LI3 Interface Module and the Interface Power Supply ACC H 2 Plug the 6 Serial FSA Cable into an available DB9 COM port on your computer 3 Plug the Interface Power Supply into the back of the Interface Module 4 Plug the 6 Serial FSA Cable s 8 wire plug end into the back of the Interface Module 5 Plug the Interface Power Supply into a power source If connected properly the green LED lights on the interface module will illuminate indicating the interface module is receiving power 6 Refer to same as step 6 under USB Connection Type 4 and Type 5 5E Interface Modules NOTES As of November 1st 2009 the LI3 6 FSA Serial Cable and LI5 6 Serial Extension Cable will no longer be provided with your FSA system They are available as optional accessories if required please contact your distributor The behavior of the LED lights on the interface modules changed for software version 4 0 227 and up If you are using FSA software prior to 4 0 227
20. then reconnecting the power source from the device We recommend the use of a suitable surge protector with the FSA interface module as would be appropriate with any computer and or computer peripheral 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 Itis the operator s responsibility to ensure all cables are in good condition inspect all cables for nicks or abrasions prior to each use To clean disconnect the module from the power supply Wipe the exterior of the interface module with a soft cloth dampened with water Do not use liquid or aerosol cleaners which may contain flammable substances Also see Safety Notices CAN CSA C22 2 601 1 M90 UL 60601 1 and EN60601 1 Electronic Emissions Notices below Improper care and or use of the FSA Interface Module could possibly lead to malfunction failure or damage to the FSA Interface Module If function stops during electrostatic discharge to the device reset the system by unplugging from the PC rebooting the PC and plugging in the module FSA4 Instructions for Use ENGLISH A4 ver 4 rev 3 doc 6 11 User Assistance Information If you have any questions about the FSA System 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
21. ustomer or the ae of the lt a should assure that it is used in such an environment Emissionstest test Compliance Electromagnetic environment 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 directly 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 Warning This equipment system is intended for use by healthcare professionals only This equipment system may cause radio interference or may disrupt Voltage fluctuations flicker the operation of nearby equipment It may be necessary to take mitigation an r Complies measures such as re orienting or relocating the equipment or shielding the location IEC 60601 1 2 2004 Ed 2 1 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 Electrostatic discharge 6 kV contact 8 kV a
22. you will need to install the current software and upload the current firmware to your interface module in order to get the LED behavior outlined above see Section 4 Uploading Firmware below If you install the current software and elect to not perform an Upload Firmware your LED behavior will remain as is please refer to the user manual that shipped with your existing interface module 4 Uploading Firmware 1 Install the current software as explained in section 2 2 Connect your interface module to your computer as instructed in sections 3 1 or 3 2 3 Open the software go to Tools System Settings Interface Module and click the Upload Firmware button The Upload Firmware Wizard will step you through uploading current firmware to your interface module so the LED s behave as described in sections 3 1 or 3 2 5 Installing the FSA USB Drivers As of FSA software version 4 0 219 CD or internet download versions the USB drivers for your FSA Type 4 5 and 5E Interface Modules as well as the optional FSA Autocalibrator will install over the internet or when the software is installed 6 Basic Software Operation 1 Double click on the FSA4 icon on your desktop to run the program 2 Go to File New and select either your mat type from the Template tab or your mat s serial number from the Sensor arrays tab 3 Click OK Your FSA Status bar should indicate Ready to Read and a serial number should be displayed If the serial number indi
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