Instructions for Use HVLab Thermal Aesthesiometer
Contents
1. 27 9 TROUBLESHOOTING GUIDE sciences aurane aaae nacida rancia laica asias 28 10 CE DECLARATION OF CONFORMITY ccccccceseeceseseeeeeeeeeeeeseeneeseseeeeesesesneeseeeseeeseseseenenseenenens 29 ANNEXE A INTERFACE OF THE USB 2527 COMPUTER INTERFACE ccccceesesceceereseesenteseeseneeees A1 ANNEXE B INSTALLING AND SETTING UP THE SOFTWARE 0cccscceencseceenseseceeseseeeeseseesensnees B1 B 1 Software installation OPUS oca ii da taa ad citada B1 B 2 Performing a new installation lt A B1 B 3 Performing an installation over a distributed NetwOrKk coooonninicicnnnnnnnnnnncococcccccnoconannnos B2 Document no TA 009 HVLab Thermal Aesthesiometer Page 3 of 29 Issue 6 0 Instructions for Use 08 03 10 1 System Information This manual was supplied with the following system Device HVLab Thermal Aesthesiometer Model Number TA3 0 Manufacturer and Contact Details Human Factors Research Unit Institute of Sound and Vibration Research University of Southampton 0086 Highfield Southampton SO17 1BJ United Kingdom Telephone 44 0 23 8059 2277 Fax 44 0 23 8059 2927 Email hvlab soton ac uk Document no TA 009 HVLab Thermal Aesthesiometer Issue 6 0 Instructions for Use 08 03 10 Page 4 of 29 2 Product Specification The HVLab Thermal Aesthesiometer provides measurement of tactile perception thresholds for thermal stimuli i e the minimum change in temperature which can be perceived at various sites2. Close the Digital Signature Details dialogue and the Certificate Information dialogue so as to return to the original security warning xii At this point you might or might not have the option to check the box for Always trust files from this publisher If you do have the option check the box and click on Open to launch the HVLab software If you don t have the option then you will have this option when you launch the HVLab software the second time If you do not check the box then Windows will always prompt you every time you launch the software xiii You will be required to enter a valid User ID and Password the default Personal ID is admin with Password hvlab Additional users can be added or deleted after the software has been successfully set up see HVLab Diagnostic Instuments Manager Database User Manual for further details xiv Click on Continue The first time that the software is run the location of all the software components will be automatically detected and displayed in the Database Components window The default location for all the components is in InstallPath and InstallPath Data where InstallPath is the folder into which the software was installed which defaults to C My Documents HVLwin84 for version 8 4 It is possible to move the database components to a different location such as the data folders to a folder on a shared network drive see HVLab Diagnostic Instuments Manager Database U
3. 3 3 Setting up the Thermal Aesthesiometer cccccc cc ecce cet ee secede eee lected 8 4 RUNNING A THERMOTACTILE PERCEPTION THRESHOLD TEST ccccssseeecesseeeeeeesseenens 10 4 1 The Control Panel WINdIW vsrcaiia ie onto ehiw lance eines 10 4 1 1 Current Subject iii eds 10 41 2 DIAgnostle Pes uds odios 11 4 2 Thermotactile Threshold Test Window oooooooonccnnnccnononcooooononono nono nono no nono no nnnnnnnnnnns 11 4 2 1 SUBO Dal de 11 4 22 Test Parameters A Se ee ee a Bales oo ed See Sal 12 4 2 3 VOSUCGCUAIS das ies slob ade II ated eer aera ets 14 AZA TSR SUMS eta a A cas E E E O EEES 15 425 Calibration oia 15 4 3 The Thermotactile Threshold Measurement WindOW ooooooccccnononoconononoononnnnnnnnnnnnos 15 4 4 Viewing Previously Collected Test Results 20 4 5 Printing a POSURE CONG atrio a cid cien 20 4 6 Manually Entering Test ResultS ooooooooccnnnnnccnnoncconononononn cnn cnn nn nn nono eee 21 427 Editing Test RESUNS nii culiao 21 MT 1 AA teen a a tis eats ce celts cost cate terei aaea 21 AZ Edt Parameters roo oa 21 A O Edit Notes ana Testeado lia tl dia 22 4 7 4 Edit Data File Name utili 22 5 MAINTENANCE ocio 23 SA IN A O er rae ere eee ree 23 A E 1 2 22 1 sangre ta re tT rade ETTE 23 5 3 Regular performance checks by the USED ooooccccococonocoococcnnnnnnnnnnnnnnnnnnnn nono nonnnnnnnnnnns 23 6 WARNINGS AND PRECAUTIONS cccccccesseceeseseeeeeeeseeeeeseseeeseeeseeseeesaesesesae
4. Free probe Cold test 1 standard deviation Seconds 360 Left index Site Left index Reversals fe Reference C 325 Status Hold contact plate against test site Click START to continue Figure 6 Thermotactile Threshold Measurement window The experimental subject or patient should be given clear instructions concerning the experimental procedure before the first measurement is performed Table 1 describes the procedure for measuring thermotactile thresholds at the fingertip Precautions that should be taken to ensure reliable measurements are outlined in Section 6 4 of this manual Table 1 Instructions for experimental subjects or patients when measuring thermal thresholds at the fingers a Rest your finger on the top of the applicator so that the fleshiest part of your finger tip is in the centre of the contact plate b Make sure that during the test procedure you maintain contact with the applicator contact pad without exerting excessive pressure c Hold the response button in the opposite hand with the thumb over the button d When you perceive a change in temperature of the contact pad press the response button and then release it the temperature will return to its original level e When you perceive another change in temperature press the response button again This cycle will repeat until the experimenter tells you the test is complete Document no TA 009 HVLab Thermal Aesth
5. Instruments Manager is ready to be used To be able to access the HELP documents from the HVLab software you will need to install Acrobat Reader version 6 0 or above on your computer If you do not already have it you can install Acrobat Reader from the CD by running D Acrobat ReaderlAdbeRdr910_en_US_Std exe from the Run dialogue or using Windows Explorer Start the HVLab software by selecting HVLab diagnostic instruments from the Start Programs menu or by clicking on the HVLab diagnostic instruments icon on the desktop When the software is launched for the first time Windows may display a security warning asking if you want to block unsafe expressions you should always click on Yes You may then be asked to restart the application Document number TA 009 HVLab Thermal Aesthesiometer Page B1 Issue 6 0 Instructions for Use 08 03 10 xi Windows may then display another security warning stating This file has been digitally signed by HVLab This publisher has not been authenticated To prevent recurrences of this warning you should install a digital certificate by clicking on Details Click on View Certificate in the Digital Signature Details dialogue then on Install Certificate in the Certificate Information dialogue This will launch the Certificate Import Wizard Accept all the default options and click Yes to confirm that you want to install the certificate from a certification authority claiming to represent HVLab
6. Mean cold threshold Free probe Cold test a MN Save as type Ta Results TAD y Cancel Places 1 standard deviation Z Site Left index Reversals B Reference C 325 Status End Cold Test Figure 9 Dialogue for saving thermogram data file The test results will be transferred automatically to the database and displayed in the relevant fields The Running Test and Importing Results dialogue is shown while the results are being transferred This process can take several seconds SA uE s Number of measurements 8 Edit Delete Forename Defaut Reference W EE E nud dead Rater ics Date of birth 01 01 1930 Se Waiting for data transfer Ni Reference ps2 Number Delay betwee The database is waiting fo the testto finish Date of entry 08 06 2005 and for saved or updated results to be Record probe t transferred to the database this may take up to 10 seconds to complete This window Test Details will close automatically when the data have been imported Room temperature 0 g Measurement it FST Left 0 C ss eae 3 s Left index If this dialogue fails to close or if you wish EST gE oe to cancel the date transfer select Left little gt A Bes TA Serial No TA157 Cancel Import from the File menu Fight index Test date 02 03 2007 16 34 54 Fight little Tester Administrator Left index Data File No file selected Left little Browse Fight i
7. To edit the parameters in the currently selected Parameter Set click on Edit Delete in the Thermotactile Threshold Test window Change the desired parameter and then click Save It should be noted that any alterations to the test parameters may affect the thermotactile thresholds obtained You can also edit the test parameters for Measurement Site while carrying out a test by going to the Edit menu located on the menu bar and selecting Edit Parameters However this will only change the parameters for that particular test 4 2 3 Test details The Test Details section Figure 4 includes values for Room Temperature and Finger Skin Temperature left hand and right hand These should be entered before the test results are finally saved a warning will be given by the software if values have not been entered The values can be entered manually or will be entered automatically from a previous test The TA Serial No field displays the serial number of the Thermal Aesthesiometer which is currently connected to the computer You can enter the serial number of the equipment in the Database Components window by selecting the Edit Components from the File menu located on the menu bar at the top left hand corner of the Control Panel window Then scroll Document no TA 009 HVLab Thermal Aesthesiometer Page 14 of 29 Issue 6 0 Instructions for Use 08 03 10 Z down the window until you see the Available Tests and Health Surveillance Questionnaires tabl
8. Vac 100VA 110 to 120Vac Complies with the following standards Medical electrical equipment Part 1 General requirements for basic safety and essential performance Document no TA 009 HVLab Thermal Aesthesiometer Page 6 of 29 Issue 6 0 08 03 10 Instructions for Use 3 Installation and commissioning 3 1 System components If any of the following items are missing please contact the manufacturer the system components are illustrated in Figure 1 a Control Box b Applicator c Subject Response Button Figure 1 System components see Section 3 1 Document no TA 009 HVLab Thermal Aesthesiometer Page 7 of 29 Issue 6 0 Instructions for Use 08 03 10 d K type thermocouple e Computer Interface Cable f Power Supply Cable g Additional Protective Earth cable h USB 2527 Computer Interface i USB cable 3 2 Setting up the controlling computer and software The Thermal Aesthesiometer is controlled by the HVLab Diagnostic Instruments Manager software running on a suitable personal computer The computer should have the following minimum specification e Pentium processor 1 5 GHz or more e Microsoft Windows XP operating system e Display resolution of at least 1024x768 pixels e CD ROM drive e More than 100 MB free on drive C e One USB2 0 port for connection of a USB 2527 interface board Follow the instructions in Annexe A of this manual for installing the interface board and in A
9. in the bottom left corner of the window to save the test record to the database and return to the Control Panel window Alternatively clicking Cancel will return to the Control Panel window without saving the test results 4 2 5 Calibration The Calibration button opens the Calibration window This window provides a means for monitoring temperature during calibration procedures Please read section 5 3 4 3 The Thermotactile Threshold Measurement Window Clicking on Start opens the Thermotactile Threshold Measurement window At the top of the screen are the buttons to Start Stop Cancel or Save The name reference number of the current subject and the date and time of test are also displayed At the bottom of the screen are the Site number of Reversals Reference temperature C and Status of the current measurement Figure 6 This window which displays results of the thermotactile threshold measurements is also called a thermogram Document no TA 009 HVLab Thermal Aesthesiometer Page 15 of 29 Issue 6 0 Instructions for Use 08 03 10 H Lab Thermal Aesthesiometer Measurement l Fie View Help Start Stop Cancel Save Next Measurement Hot Threshold E Thermotactile Threshold Measurement 1 Simulation SUBJECT Test Subject REFERENCE TS1 50 DATE and TIME 31 Jan 2006 15 48 07 45 401 r 30 eee Hot test data e Mean hot threshold Free probe Hot test eum Cold test data 15 a Mean cold threshold e
10. mean sdey print mean sdew zone C FST Right c a z 1 l t litt l TASerialNo z x Right index a E Start Test date 03 09 2007 15 13 28 Right little E l F Start Tester Administrator fleft index a E Start Data File No file selected Left little a l L _ Start Browse Right index a E Start Right little E E l Start Run as a simulation q Notes Save and Exit Calibration Cancel Figure 4 Thermotactile Threshold Test window 4 2 2 Test Parameters The Test Parameters section shows parameters of the thermotactile measurements that will be performed in the current test The Measurement Sites are shown in the Test Results section These parameters may be altered from the default values by selecting different parameter sets using the Parameter Set Name list box Additional parameter sets may be entered into the database and existing parameter sets may be altered or deleted by clicking the Add New or the Edit Delete controls see section 4 2 2 10 The Test Parameters section includes the following values 4 2 2 1 Parameter Set Name The name of the current parameter set 4 2 2 2 Number of Measurements The number of test measurements to be completed A measurement refers to the threshold determined at one test site with either a hot test or a cold test or both The default value is the maximum of 8 measu
11. or measurement sites into the database during manual data entry Document no TA 009 HVLab Thermal Aesthesiometer Page 21 of 29 Issue 6 0 Instructions for Use 08 03 10 4 7 3 Edit Notes and Tester This command allows you to edit the notes section and the name of the tester You may used this command if you wish to add more comments to the notes section in any test record or have accidentally entered the wrong comments and name of the tester into the database during manual data entry 4 7 4 Edit Data File Name This command allows you to edit the location of the file where the data has been saved into You may use this command if you have accidentally entered the wrong location of the data file during manual data entry or if you would like to update the location of a data file which has been moved to another location on your PC in any test record When you have completed editing click Close to save the changes Document no TA 009 HVLab Thermal Aesthesiometer Page 22 of 29 Issue 6 0 Instructions for Use 08 03 10 5 Maintenance 5 1 Cleaning The subject response button and the applicator plate should be cleaned with an anti bacterial wipe between each patient or subject 5 2 Calibration All HVLab Diagnostic Instruments are calibrated and quality controlled prior to delivery A full calibration report is attached to this manual as Annexe 1 The system is recommended to be re calibrated at 12 monthly intervals and also if the equ
12. you to browse for the data file Alternatively you can edit the Data File location see section 4 7 The thermogram can be printed to the default printer on your computer or exported as a bitmap by selecting Print Graph or Export Graph from the File Menu The scaling of the thermogram graph i e the x and y axis limits may be adjusted by selecting Rescale Graph from the View menu This replaces the status fields at the bottom of the window by text controls showing the current axis limits which can be incremented or decremented by clicking on the associated scroll buttons The thermogram data reversal points and calculated thresholds may also be exported to a CSV file by selecting Export Results from the File Menu Click Cancel to return to the Thermotactile Thresholds Test window 4 5 Printing a Test Record A test report of the test record can also be previewed and printed Figure 11 from the Thermotactile Threshold Test window by clicking the Print Record button at the bottom of the window The test report can look different for different versions of the software The software compares the results of the thermotactile threshold test the vibrotactile threshold test the finger rewarming test and the finger systolic blood pressure test to normal values as according to the Standard diagnostic methods for assessing components of hand arm vibration syndrome guidelines published by the Health and Safety Executive UK You can access
13. 7 interface supplied with your system should be installed before the HVLab software please refer to Annex A Interface board installation The HVLab Diagnostic Instruments Manager stores test and questionnaire data in a MS ACCESS database MS ACCESS 2003 can be installed on your computer but it is not needed to run the HVLab software However all earlier versions of MS ACCESS are not compatible with HVLab and must be removed Some computers with P4 processors are capable of HyperThreading Technology HyperThreading is not compatible with HVLab software and must be disabled in the computer s BIOS setup program Close any Windows programs that are running Put the installation CD into your CD ROM drive Assumed to be drive D Note If your CD ROM drive is not drive D or if you are installing from a network drive then replace D in the following with the drive letter corresponding to your installation drive If the installation process does not start automatically select Run from the Microsoft Start Menu This will open the Run dialogue window Enter D Setup Exe then click on OK Follow through the installation When choosing the setup type it is recommended that you choose a Typical installation By default the software will be installed into C My Documents HVLwin84 for version 8 4 Choose a Custom installation if you want to install HVLab into a different directory After clicking Finish the HVLab Diagnostic
14. Device After clicking Finish Windows will again launch the Found New Hardware Wizard Select No not this time when asked if you want to connect to Windows Update to search for software and click on Next Then click on Install the software automatically when Windows detects the USB 2527 After installing the USB 2527 click Yes when Windows prompts you to restart your computer After installing the USB 2527 run the InstaCal programme by clicking on the shortcut in Start Programs MeasurementComputing it is recommended that the InstaCal shortcut be copied to the desktop for easy access to configure and self calibrate the analogue inputs and outputs Instacal should automatically detect and list the USB 2527 on the USB bus Make sure that USB 2527 is checked and click OK to continue To work with HVLab software the USB 2527 board number must be designated as Board 0 i e board zero If you find that another board e g a Demo Board is currently board zero then right click on this board and select Remove Board to delete it Right click on the USB 2527 select Change Board and select board zero Make sure your USB 2527 is configured for 16 Single Ended analogue input channels Click on the USB 2527 to highlight it then right click on this and select Configure Check that No of Channels 16 Single Ended After installing and configuring your USB 2527 interface you will need to calibrate the analogue inputs Make sure noth
15. Exceeded or the Below Lower Temperature Limit will appear For safety purposes the temperature of the applicator will continue to return to the reference temperature without any button presses The operator can decide if they would like to Accept the threshold at 55 C or 10 C as part of the results Reject the threshold judgement which means that this judgement is not used as part of the results or Stop the test completely Click Save to return to the Thermotactile Threshold Test window The thresholds and standard deviations will be transferred automatically to the database and displayed in the relevant fields You will be prompted to save the complete thermogram as a TAD file the software will automatically suggest a filename using the reference number and date in the Data folder but you may choose a different filename and or location Figure 9 Document no TA 009 HVLab Thermal Aesthesiometer Page 18 of 29 Issue 6 0 Instructions for Use 08 03 10 H Lab Thermal Aesthesiometer Measurement o File view Help Start Stop Cancel L Save Current Measurement Cold Threshold D Save As 24x Save in o Data e e El Fe My Recent est Subject TS1 IME 31 Jan 2006 15 48 07 imulation tad D t do Hot Hot Cold Cold NZone E T hold SD T hold SD zone c tc tC tf C Desktop 38 2 0 38 254 1 75 129 My Documents Hot test data Mean hot threshold ped Free probe Hot test E Cold test data e File name
16. Instructions for Use HVLab Thermal Aesthesiometer Human Factors Research Unit Institute of Sound and Vibration Research University of Southampton Southampton S017 1BJ UK HVLab document number TA 009 Issue Date DRF No Description ss Signature 03 08 04 009 Firstissue CHL 10 08 04 Addition of CE mark v7 software _ Se ea A information 03 09 07 Test and installation instructions updated for v8 software 26 05 09 244 Clarification to recommendation for intervals of regular calibration SAS 08 09 10 263 Updated technical specifications figure for USB setup system information Annexe A and Annexe B Removed Annexe C Document no TA 009 HVLab Thermal Aesthesiometer Page 0 of 29 Issue 6 0 Instructions for Use 08 03 10 Thermal Aesthesiometer Instructions for Use Document no TA 009 HVLab Thermal Aesthesiometer Page 1 of 29 Issue 6 0 Instructions for Use 08 03 10 Table of Contents 1 SYSTEM INFORMATION tice cccccsccediccctecceccccecdescdtecvevsetecadesduecdessatecdeesdtecsuesdeeeddesduecdussdeesddecdiesvevsdeerds 4 2 PRODUCT SPECIFICATION jj ooe0c seccccey sot ch cetecceevyseuptvcessectsteseiecevesccesvegucsevescecoereqrscrveseqtaetreestivees 5 21 TECHNICA POCAS ii A EEE RE PETE eF 5 3 INSTALLATION AND COMMISSIONING c ooocccccooccccconnccccnnncccnnn encerrar 7 IN System COMPONEN Sa is 7 3 2 Setting up the controlling computer and software ooooonnncnnnccccnnccccnnnnanannncnnnccnnnnnnns 8
17. Replace with a spare thermocouple if necessary The thermal aesthesiometer shows a low reference temperature The thermal aesthesiometer has not been reset Press the reset button on the front of the control box If any of the above suggestions do not solve your problem please contact the manufacturer by telephone on 44 0 2380 592277 Document no TA 009 Issue 6 0 08 03 10 HVLab Thermal Aesthesiometer Instructions for Use Page 28 of 29 10 CE Declaration of Conformity U niversity Institute of Sound and University of Southampton Vibration Research Highfield of Southam pton Southampton Human Sciences Group SO17 1BJ United Kingdom CE Declaration of Conformity HVLab Diagnostic Instruments 0086 Comprising of Vibrotactile Perception Meter Thermal Aesthesiometer Multi Channel Plethysmograph 8 Channel Temperature Monitor This is to certify that the above products conform to the Essential Requirements of the Medical Device Directive 93 42 EEC as demonstrated through the documentation of a Technical File in accordance with Annexes VII and VI All products being inspected and tested in accordance with procedures compliant to BS EN ISO 13485 2003 and the additional requirements of the Medical Device Directive 93 42 EEC and amendments thereto This declaration is subject to the issue and maintenance of a certificate issued by a Notified Body Signature Nt Professor M J Griffin Ma
18. ad the HVLab Diagnostic Instruments Manager Database Instructions for Use before proceeding When you start the HVLab Diagnostic Instruments Manager software the Control Panel window opens as shown in Figure 2 This window is divided into three main sections Current Subject which shows the currently active record in the subject or patient database Diagnostic Tests which provides access to the individual tests and databases of test results and Questionnaires which launches a health surveillance questionnaire database if this has been provided 4 1 The Control Panel Window H LAB Diagnostic Instruments Control Panel 01 xj File Edit Yiew Tools Help al xi Database Version 7 0 Subject Number fi Surname Subject Forename Test Date of Birth ai January 1960 Start New Test Manual Data Entry Reference Number Ts1 View Test Results Date of Entry 30 August 2005 Gender a Male Female Preferred Hand Right Left Either Questionnaire Health Surveillance Questionnaire View Full Details Add New Record Add New Subject Find Subject View Records User Details Exit Database E pus Current User dministrato Record ml 1 gt ra fr of 1 Form View F O um T Z Figure 2 Control Panel window 4 1 1 Current Subject Before running a test it is necessary to enter the details of your test subject or patient int
19. asures include the use of ear defenders ear plugs or masking tones for the duration of each measurement 6 4 5 Finger contact For measurements on the finger it is recommended that thresholds be obtained for the volar surface of the distal phalanx of the fingers with the centre of the whorl in contact with the applicator The finger should be located in the centre of the applicator 6 4 6 Instructions to subjects All subjects should be given a set of written instructions This is done to ensure that nothing is omitted when preparing the subject for the test and that the psychophysical response is not affected by giving subjects differing instructions Table 1 see section 4 3 shows a sample set of instructions which may be copied for use in combination with the Thermal Aesthesiometer 6 4 7 Location of the applicator Position the applicator unit on a firm level surface that is isolated from the surface supporting the controlling computer which contains cooling fans or any other sources of vibration It is desirable to use an arm rest to avoid fatigue of the arm or finger as this can lead to temporary threshold shift 6 4 8 Length of test Long test durations resulting from inappropriate selection of test parameters can induce subject fatigue and unreliable threshold measurements To prevent a measurement becoming excessively long a single threshold test has been limited to a duration of 10 minutes The threshold is calculated from rev
20. be during the threshold measurement For example you may wish to have a record of the room temperature during the test Document no TA 009 HVLab Thermal Aesthesiometer Page 13 of 29 Issue 6 0 Instructions for Use 08 03 10 4 2 2 10 Editing and creating new test parameters To create a new set of test parameters click Add New to open the Thermotactile Threshold Test Parameters window Figure 5 This contains three sections Parameter Set General Settings and Settings for Individual Measurements Thermotactile Threshold Test Parameters E car Name Administrator Test Order Hot then Coldtet y Number of Measurements 8 E Parameter Set Name pE Reference Temperature C 325 zil Temperature Increment Rate C s EE Temperature Decrement Rate C s pi i Number of Reversals 6 zll nar pi Heachrement Site Delay Between Reversals seconds 3 i l EE fl letindes SS Upper Temperature Limit C 55 Lower Temperature Limit C m Record Free Probe l Save Delete Cancel Figure 5 Thermotactile Threshold Test Parameters window To define a unique parameter set alter the values as appropriate within the General Settings section The Settings for Individual Measurements section allows you to define test sites for each of the measurements Once you have finished defining your parameters label the parameter set in the Parameter Set Name field and click Save
21. e and enter the serial numbers of each instrument connected to your computer in the Serial No column see HVLab Diagnostic Instruments Manager Software User Manual for further details The Tester field identifies the person that performed the test this defaults to the name of the user who is currently logged in to the database programme The Data File field is used by the software to store the location of the data file which contains the thermograms see section 4 3 of the individual threshold measurements Check Run as a simulation if you wish to run a simulated test without a subject for demonstration 4 2 4 Test Results This section contains the hot and cold thermotactile thresholds standard deviations and neutral zones for each of the test sites using the current defined parameters The controls in this section allow you to start and repeat thermotactile threshold measurements Click one of the Start buttons to launch a thermotactile threshold measurement The fields to the left of each button show the test site to which the applicator should be applied Clicking Start opens the Thermotactile Threshold Measurement window Figure 6 where you can perform the individual threshold measurement and save the thermotactile thresholds and standard deviations back to the database Please read section 4 3 for instructions on how to perform a thermotactile threshold measurement When all the measurements have been completed click Save and Exit
22. e manufacturer can not be responsible for any damage or injury sustained for external devices failing to meet these criteria 6 4 Obtaining reliable measurements In order to obtain repeatable measurements of thermotactile thresholds attention should be given to various factors these include 6 4 1 Finger skin temperature Finger skin temperatures at the measurement locations should not be below 22 C If the reference temperature is not to be set to the skin temperature it is advisable to maintain a contact between the applicator and the test site for a fixed period before testing so that the skin may adapt to the reference temperature 6 4 2 Previous exposures to vibration Exposure to vibration immediately prior to measurement of thermotactile thresholds might result in a temporary threshold shift Any temporary threshold shift should be allowed to recover before measurement of thermotactile thresholds 6 4 3 Previous exposure to extremes of temperature The subject should be allowed to acclimatise to the temperature of the room for a suitable amount of time before testing to ensure thermal equilibrium Document no TA 009 HVLab Thermal Aesthesiometer Page 24 of 29 Issue 6 0 Instructions for Use 08 03 10 6 4 4 Auditory cues Noises in and around the testing location during measurements may be distracting Precautions should be taken to ensure that the subject is not unnecessarily disturbed during testing Suitable precautionary me
23. ed for C diagnostic comparison Yes Left index Hot Yes Left index Cold Yes Left little Hot Yes Left little Cold Yes Right index Hot Yes Right index Cold Right little Hot Right little Cold Possible Definite 0 38 gt 45 gt 485 1 75 lt 22 lt 19 0 62 gt 45 gt 485 1 21 lt 22 lt 19 1 03 gt 45 gt 485 0 55 lt 22 lt 19 0 85 gt 45 gt 485 0 72 lt 22 lt 19 o 0 O lo jojojoj o IN o N Figure 11 Example of diagnostic test report In Print Preview 4 6 Manually Entering Test Results To manually enter test data for the current subject select the required Diagnostic Test and click Manual Data Entry Enter your test data in the respective boxes and click Save and Exit when you have fnished 4 7 Editing Test Results If you wish to modify the test results in any test record you can do so using the following commands from the Edit menu located on the menu bar Edit Results Edit Parameters Edit Notes and Tester and Edit Data File Name Use these functions only when necessary 4 7 1 Edit Results This command allows you to edit any of the test results in the current test record You may use this command if you have accidentally entered the wrong test results into the database during manual data entry 4 7 2 Edit Parameters This command allows you edit the test parameters and measurement sites in the current test record You may use this command if you have accidentally entered the wrong test parameters
24. er a network must have full access rights to this location on the network Document number TA 009 HVLab Thermal Aesthesiometer Page B2 Issue 6 0 Instructions for Use 08 03 10 ii iii iv v Start the HVLab software on each computer by selecting HVLab Diagnostic Instruments from the Start Programs menu or from the desktop You will be required to enter a valid User ID and Password the default Personal ID is Admin with Password hvlab Additional users can be added or deleted after the software has been successfully set up see HVLab Diagnostic Instuments Manager Database User Manual for further details The first time that the software is launched on each computer the location of all the software components will be automatically detected and displayed in the Database Components window The default location for the file containing the data tables HVLab_di_tables mdb is InstallPath Data where InstallPath is the folder into which the software was installed which defaults to C My Documents HVLwin84 for version 8 4 Use the browse button to the right of the displayed data path to find the copy of the data tables that have been moved to the network see ii above The five data folders for the individual test data should also be relocated to the data folder on the network see HVLab Diagnostic Instuments Manager Database User Manual for further details Scroll down the Database Components window until you see t
25. ersals completed within the allotted time Document no TA 009 HVLab Thermal Aesthesiometer Page 25 of 29 Issue 6 0 Instructions for Use 08 03 10 7 Spares and ancillary services The following accessories are available from the manufacturer Please refer to the contact details at the beginning of this guide If you wish to replace or have spares of a specific component please contact us and we will endeavour to help you Subject Response Button K type Thermocouple Distribution Box to allow a complete suite of HVLab instruments to be controlled by a single computer and interface board We can also provide training calibration and auditing of the operation of all diagnostic instruments Please contact the manufacturer for a quotation Document no TA 009 HVLab Thermal Aesthesiometer Page 26 of 29 Issue 6 0 Instructions for Use 08 03 10 8 Disposal 8 1 Information on Disposal for Users of Waste Electrical amp Electronic Equipment excluding private households Used electrical and electronic products must not be mixed with general waste Disposing of this product correctly will save valuable resources and prevent any potential negative effects on human health and the environment which could otherwise arise from inappropriate waste handling if you are unsure of your national requirements with respect to disposal Please contact your local authority dealer or supplier for further information Penalties may be applicable for inco
26. esiometer Page 16 of 29 Issue 6 0 Instructions for Use 08 03 10 H Lab Thermal Aesthesiometer Measurement File View Help Start Stop rt i Save Next Measurement Cold Threshold 7 Thermotactile Threshold Measurement 1 Simulation SUBJECT Test Subject REFERENCE TS1 DATE and TIME 31 Jan 2006 15 48 07 RESULTS Measurement Hot Hot Cold Cold T hold SD T hold SD T C E T 1 Left index 38 2 0 38 00 0 00 35 30 25 Hot test data Mean hot threshold 20 Free probe Hot test co Cold test data 15 a Mean cold threshold mm Free probe Cold test 10 1 fi n 1 fi L 1 standard deviation 0 Seconds 360 Left index Site Left index Reversals 6 Reference C 325 Status Click START to run cold threshold measurement AAA ees Figure 7 Results of a Hot Thermotactile Threshold Measurement Click Start to commence the threshold measurement The test can be interrupted at any time by clicking Stop Clicking Cancel will be return to the Thermotactile Threshold Test window and any data will be lost The thermogram is displayed in real time as the response button in pressed and released Once the measurement is complete the mean threshold and standard deviation is displayed in the thermogram Figure 7 If you click Stop during the measurement the mean threshold calculated will be the mean of the reversals which have been performed If the hot and cold threshold test has been performed on o
27. g may be removed and the cable connected to a fixed and permanently installed Protective Earth Conductor The additional protective earth should be connected at all times when the system is in use for testing patients or experimental subjects Document no TA 009 HVLab Thermal Aesthesiometer Page 8 of 29 Issue 6 0 Instructions for Use 08 03 10 Connect the Computer Interface Cables to the connector marked Equipment Interface on the USB 2527 interface box Press the green button marked power on the front of the control box to switch on the Thermal Aesthesiometer You should see the following e A green power light on the front of the control box e Anorange light on the front of the control box when the response button is pressed The Display button on the front of the control box can be used to switch the applicator temperature display on and off Your HVLab Thermal Aesthesiometer is now ready for use Please refer to the troubleshooting guide if necessary Document no TA 009 HVLab Thermal Aesthesiometer Page 9 of 29 Issue 6 0 Instructions for Use 08 03 10 4 Running a thermotactile perception threshold test Thermotactile threshold measurements are controlled from the HVLab Diagnostic Instruments Manager software The Diagnostic Instruments Manager programme integrates the software that controls the Thermal Aesthesiometer and other HVLab diagnostic instruments with a relational database of subjects patients and test results Please re
28. he Available Tests and Health Surveillance Questionnaires table and make sure that the boxes in the Enabled column are checked for all the tests or questionnaires which you want to be available on your computer An appropriate instrument should be selected in the Instrument column for each test that has been enabled Make sure that the serial numbers of each instrument connected to your computer are entered in the Serial No column The Interface column should be set to MCC for each of these instruments Tests for which you do not have the necessary instrument hardware connected can be run in simulation mode check the boxes for these tests in the Simulation column or they can be left unchecked When you are satisfied that all the components tests and boards have been specified correctly click on Save This will link the database program to the tables and open the main Control Panel window Document number TA 009 HVLab Thermal Aesthesiometer Page B3 Issue 6 0 08 03 10 Instructions for Use
29. ing else is connected to your board during the calibration Click on your USB 2527 to highlight it then click on A D button to self calibrate the analogue inputs Click on Calibrate and then OK when calibration is complete This procedure should not need to be repeated unless the board is replaced or moved The USB 2527 is now ready to be used The USB 2527 should always be connected to the same port that it was installed to If it is moved to another USB port on the same computer the Instacal and HVLab software will not be able to find the interface unless it is re installed and re configured You will need to follow steps 3 to 7 to reinstall the interface again Document no TA 009 HVLab Thermal Aesthesiometer Page A1 Issue 6 0 08 03 10 Instructions for Use Annexe B Installing and setting up the software B 1 Software installation options Before performing the installation of the software decide whether you want to perform A new installation this would mean that the PC has never been installed with the HVLab Diagnostic Instruments Manager software This is explained in Section B 2 An installation on a distributed network this means that you would be able to perform different tests and view the test results with the same database using separate computers which work over a network This is explained in Section B 3 B 2 Performing a new installation i ii vi vii viii ix x The USB 252
30. ipment is moved to a new site It is recommended that the calibration procedures are carried out by the manufacturer or by a suitably trained person Additionally regular performance checks should be carried out by the user as described in Section 5 3 The manufacturer bears no liability for injury to any person resulting from removal of equipment casings The manufacturer does not guarantee that calibrations carried out by any person other than one designated by the manufacturer will result in satisfactory performance of the system 5 3 Regular performance checks by the user The calibration of the two thermocouples are checked and adjusted during manufacture However periodic calibration checks are advisable To do this first disconnect the applicator and then connect free probe thermocouples to both the Applicator Thermocouple and Free Probe Thermocouple sockets Open the calibration screen in the software Test menu Place the thermocouples in a temperature controlled water bath 30 35 C with a mercury in glass thermometer which is accurate to 0 1 C With the water being constantly stirred and the thermocouples not touching the side of the bath the screen should show the same temperature for the thermocouples as is given by the thermometer Adjust the calibration controls at the back of the aesthesiometer unit PR1 and PR2 as necessary Document no TA 009 HVLab Thermal Aesthesiometer Page 23 of 29 Issue 6 0 Instruc
31. lue is set at 1 C s 4 2 2 6 Number of reversals The number of reversals may be varied from 4 to 15 The default value is set at 6 Too many repeats especially those at slow rates with long delays may result in subject boredom loss of concentration and fatigue 4 2 2 7 Delay between reversals The delay between reversals can be set between 0 to 5 seconds The default is set at 3 seconds A random element of 25 is added to the chosen delay to reduce the chance of the subject anticipating the change of temperature i e if the software delay is set to 4s the actual delay will be varied randomly between 3s and 5s 4s 25 By holding the applicator contact plate at a constant temperature between reversals the temperature of the skin at the test site is stabilised The length of the delay affects the total time required to complete a test too short a delay will not allow for the stabilisation of skin temperature and too long a delay may result in subject boredom loss of concentration and fatigue 4 2 2 8 Temperature limits The minimum and maximum temperature that the applicator will reach before cutting out are displayed here The upper temperature limit can be set between 50 C and 55 C and the lower temperature limit can be set between 5 C and 10 C The default values are set at 55 C and 10 C for the upper and lower limits respectively 4 2 2 9 Record Free Probe This function allows you to record the temperature of the free pro
32. n range 25 C s to 40 C s Error in temperature setting lt 0 5 C at 30 C lt 1 0 C at 15 C and 50 C lt 1 5 C at 10 C Rate of temperature decrement Selectable in range 0 2 C s to 2 5 C s Rate of temperature increment Selectable in range 0 2 C s to 2 5 C s Accuracy of rate of change of lt 10 error in temperature change over 15 s at temperature 1 C s from 30 C to 45 C lt 13 3 error in temperature change over 15 s at 1 C s from 30 C to 15 C Lower temperature limit Selectable in range 5 C to 10 C Upper temperature limit Selectable in range 50 C to 55 C Data sampling rate 10 readings per second Psychophysical algorithm Method of limits Averaging method Arithmetic mean of reversals Consistency checks Variability indicated by standard deviations Number of reversals 4to 15 Document no TA 009 HVLab Thermal Aesthesiometer Page 5 of 29 Issue 6 0 Instructions for Use 08 03 10 Delay between reversals Neutral zone Skin and room temperatures Temperature measurement error Dimensions Applicator Control box Power Requirements Options Compliance with standards ISO 60601 1 2006 0 to 5 s with a random variation of up to 25 Difference between hot thresholds and cold thresholds Measured by k type thermocouple lt 0 5 C in range 15 45 C Height 160 mm diameter 100 mm base diameter 55 mm top weight 0 8 kg Height 100 mm length 320 mm width 470 mm weight 6 4 kg 220 to 250
33. nagement Representative of Human Factors Research Unit 2 August 2004 Human Factors Research Unit Hearing and Balance Centre Telephone 44 0 23 8059 2277 Telephone 44 0 23 8059 2288 Fax 44 0 23 8059 2927 Fax 44 0 23 8059 3190 4981 Document no TA 009 HVLab Thermal Aesthesiometer Page 29 of 29 Issue 6 0 Instructions for Use 08 03 10 Annexe A Interface of the USB 2527 computer interface A PC which is to be connected to one or more HVLab Diagnostic Instruments must first be installed i ii iii iv v vi vii viii with a USB 2527 computer interface board according to the instructions below Put the Measurement Computing CD supplied with the USB 2527 interface into your CD ROM drive The installation process should start automatically Uncheck all boxes TracerDaq DirectX Hardware Manuals and Microsoft NET framework except InstaCal and Universal Library Follow through the installation Click Yes when you are prompted to restart your computer Connect the USB 2527 to a USB2 port on your computer Do Not connect the USB 2527 until the InstaCal software has been successfully installed When you first connect the USB 2527 Windows will launch the Found New Hardware Wizard Select No not this time when asked if you want to connect to Windows Update to search for software and click on Next Then click on Install the software automatically when Windows detects the MCC USB2 Loader
34. ndex fian ima o e T I Figure 10 Waiting for data transfer Document no TA 009 HVLab Thermal Aesthesiometer Page 19 of 29 Issue 6 0 Instructions for Use 08 03 10 If this dialogue fails to close because there was a failure in data transfer or because you cancelled a test you will need to close the dialogue by selecting Cancel Import from the File menu on the top left hand corner 4 4 Viewing Previously Collected Test Results To view the results for a particular subject ensure that the correct subject is displayed in the Current Subject section of the Control Panel window Select Thermotactile Thresholds from the drop down list in the Diagnostic Tests box and then click on View Test Results to display the Thermotactile Threshold Test window This is the same window that was used to launch the measurements except that the Start buttons for each measurement are now replaced by View buttons If there are more than one test records for the current subject you can use the navigation buttons in the bottom left corner of the screen to scroll to the required record set Click each View button to display the individual thermograms which are saved in the Data File shown in the Test Details section Alternatively click View All to display a combined thermogram for the current test record It is important that the location saved in Data File matches the location of the TAD data file on your PC If it does not a browse dialogue will allow
35. ne finger both thresholds will be presented on one thermogram figure 8 Click Restart to if you need to repeat the current threshold measurement This must be done before the data is saved and the user returns to the Thermotactile Threshold Test window To repeat a test ensure that the appropriate measurement either Hot Threshold or Cold Threshold is selected under Next Measurement at the top of the Thermotactile Threshold Measurement window and click Start This may be done as often as required Document no TA 009 HVLab Thermal Aesthesiometer Page 17 of 29 Issue 6 0 Instructions for Use 08 03 10 H Lab Thermal Aesthesiometer Measurement File View Help Start Stop Cancel Current Measurement Cold Threshold v Thermotactile Threshold Measurement 1 Simulation SUBJECT Test Subject REFERENCE TS1 50 DATE and TIME 31 Jan 2006 15 48 07 RESULTS 45 HUN 20 Measurement Hot Hot Cold Cold NZone T hold SD T hold SD zone Gc cc E Et 1 Left index 38 2 038 254 1 75 129 e Hot test data Mean hot threshold Free probe Hot test ome Cold test data 15 am Mean cold threshold sm Free probe Cold test 10 1 standard deviation 0 Seconds 360 Left index Site Left index Reversals fe Reference C 32 5 Status End Cold Test Figure 8 Results of a Hot and Cold Thermotactile Threshold Measurement If the subject does not feel a change in temperature either the Upper Temperature Limit
36. nnexe B for installing the Diagnostic Instruments Manager Software As well as controlling the Thermal Aesthesiometer Meter the HVLab Diagnostic Instrument Manager provides database software with a simple interface for entry of patient details and health surveillance information and for storing test results The database has been designed to interact with the whole range of HVLab series of diagnostic instruments allowing test results to be automatically added to the database For further information on the database software see the HVLab Diagnostic Instruments Manager Database instructions for use 3 3 Setting up the Thermal Aesthesiometer Connect the applicator cable to the connector marked Applicator and the applicator thermocouple to the connector marked Applicator Thermocouple on the front of the control box Connect the subject response button cable to the connector marked Response Button on the front of the control box Connect the k type thermocouple to the connector marked Free Probe Thermocouple on the front of the control box Connect the mains power cable between the power connector on the rear panel of the control box and a mains 220 240v AC supply Secure the spade connector on the additional protective earth cable to the green earth terminal on the rear panel of the control box The other end of the protective earth cable is fitted with a mains plug that should be connected to an additional mains socket Alternatively the plu
37. o the database by clicking on Add New Subject to open the Subject Details window Figure 3 and filling in the fields as appropriate If the subject has already been entered into the database locate the subject record using the navigation buttons in the lower left corner of the Control Panel window or click on Find Subject in the Current Subject section Document no TA 009 HVLab Thermal Aesthesiometer Page 10 of 29 Issue 6 0 Instructions for Use 08 03 10 5 HYLAB Diagnostic Instruments frmSubjectDetails Form File Edit Yiew Tools Help Subject Number E Surname s ubject Address Forename fr est Reference Number T 1 Date of Birth 0T January 1960 NI Number Gender Male Report submitted to Height m 1 6 Weight kg 5 Preferred hand Biar Marital status Single Appointment date a Time Po Ethnic group European z Entered by Administrator Date 20 Aug 05 History of changes and other information Delete Subject Undo Changes Close Figure 3 Subject Details Window 4 1 2 Diagnostic Tests The controls in the Diagnostic Tests section allow you to launch a new test or to retrieve the results of existing tests from the test results database After entering or finding your subject or patient select Thermotactile Thresholds in the Test list box Click on Start New Test to open the Thermotactile Threshold Test window as shown in Figure 4 To retrieve the results of existing tests on the c
38. on the surface of the body It may be used for the assessment of sensory changes associated with neurological dysfunction The applicator incorporates a Peltier semi conductor head pump covered by a thin metal contact plate The patient may rest a finger or toe on the contact plate or it could be held against any part of the body Tests may be performed to determine warm and cool thresholds starting from either a fixed reference temperature or the skin temperature of the patient In built safety cut outs ensure that the safe working temperature range is not exceeded The temperature probe allows for independent monitoring of another site for example room temperature or a second skin location During a thermotactile perception threshold test the Thermal Aesthesiometer is controlled by a personal computer The temperature of the applicator contact plate is increased or decreased until the patient depresses the response button The temperature of the contact plate is then returned to the starting temperature An automatic test programme repeats this process a pre set number of times to establish threshold levels for perception of warmth and cool sensation 2 1 Technical Specifications Skin stimulator contact Circular aluminium plate Contact plate diameter 55 mm Maximum temperature range 5 C to 55 C Stimulus Temperature increases or decreases from reference until response button is pressed Contact plate reference temperature Selectable i
39. rements Document no TA 009 HVLab Thermal Aesthesiometer Page 12 of 29 Issue 6 0 Instructions for Use 08 03 10 4 2 2 3 Reference Temperature The reference temperature may be varied from 25 C to 40 C in 0 5 C steps The default value is set at 32 5 C 4 2 2 4 Temperature Increment Rate The incremental rate refers to the rate at which the temperature of the applicator contact plate approaches the threshold value For a hot test this is the rate at which the temperature increases and for a cold test it is the rate at which the temperature decreases The rates of temperature increment rate may be varied from 0 2 C s to 2 5 C s in steps of 0 1 C s The default value is set at 1 C s If the increment rate is too fast there is a risk of the recorded thresholds being too high for a hot test or too low for a cold test This is a result of subject reaction time in responding to the sensation Incorrect thresholds may also be recorded if the rate is too slow because human temperature receptors adapt to slowly changing temperatures 4 2 2 5 Temperature Decrement rate The decrement rate is the rate of return to the reference temperature following a press of the subject response button For a hot test this is the rate at which the temperature decreases and for a cold test it is the rate at which the temperature increases The rates of temperature decrement rate may be varied from 0 2 C s to 2 5 C s in steps of 0 1 C s The default va
40. rrect disposal of this waste in accordance with national legislation The above information is based on the European waste electrical and electronic equipment directive 2002 96 EC 8 2 Information on disposal in other countries outside the European Union This information is only valid in the European Union If you wish to discard this product please contact your local authorities or dealer and ask for the correct method of disposal Document no TA 009 Issue 6 0 08 03 10 HVLab Thermal Aesthesiometer Page 27 of 29 Instructions for Use 9 Troubleshooting guide Problem Possible Cause Solution No Power The AC power lead has become disconnected from the control box There is no mains power supply to the control box Check that the AC power lead is connected to the control box and that the power supply is connected to the mains Pressing the subject response button does not reduce the vibration The response button is not connected The response buttons is faulty Check that the response button is connected to the front of the control box Check that the LED labelled Response lights when the button is depressed Contact manufacturer if no light is seen although button is connected Temperature display does not show any numbers K type thermocouple is not connected K type thermocouple is faulty Check that you have connected a k type thermocouple to the front of the control box
41. ser Manual for further details xv Scroll down the Database Components window until you see the Available Tests and Health Surveillance Questionnaires table and make sure that the boxes in the Enabled column are checked for all the tests or questionnaires which you want to be available on your computer An appropriate instrument should be selected in the Instrument column for each test that has been enabled Make sure that the serial numbers of each instrument connected to your computer are entered in the Serial No column The Interface column should be set to MCC for each of these instruments Tests for which you do not have the necessary instrument hardware connected can be run in simulation mode check the boxes for these tests in the Simulation column or they can be left unchecked xvi When you are satisfied that all the components are located correctly click on Save This will link the database program to the tables and open the main Control Panel window B 3 Performing an installation over a distributed network i Before launching the database on any of the computers it is necessary to create a common database table on the network On one computer only locate the Data folder in the folder into which the HVLab Diagnostic Instruments Manager software was just installed Copy this folder to a location on the network that can be accessed by all the test computers Please note that all the computers which need to use the database ov
42. seseseaeseseseeeeeeenaes 24 Document no TA 009 HVLab Thermal Aesthesiometer Page 2 of 29 Issue 6 0 Instructions for Use 08 03 10 6 1 Handling and Storage xa ccssces cee aks gece dai dead a deidad atada 24 6 2 Precautions and contra indiCatiONS ooocoonnnnnnnnnnnnccococonnnnnnnnnnnn nono non ocn nn nono nnnnnnnonns 24 6 3 Gonnection to External devices ssns srsrnisirin aniei de teniente 24 6 4 Obtaining reliable MmeasurementS ooocccccccccnnncoooccccnnnccnnnnnnnnnncnnnnnnnannnnnnnnnnnnnnnnnannnns 24 6 4 1 Finger Skin temperature iii 24 6 4 2 Previous exposures to vibration ooooooononnnnncccccccnoncnoncccnnnnncnnnnnnnnncnnnnnccnnnnnnnns 24 6 4 3 Previous exposure to extremes of temperature cccccceeeeeeeeeeeeeeeeeeeeeeees 24 O44 Audon CUeS i Se ee eee ea BA EA OE eee 25 04 5 FINGER cOntaGl te ma tie td Se ee ee E A RA 25 0 4 6 INSUUCTIONS TO SUD SCISs rociar iia 25 6 4 7 Location of the applicator ooooccccnnnnnnnononncccnnncccnononannnnnnnnnnnononnnnnnnnnnncnnnnnnnan 25 648 AONOM O LSS usina sau adenanen user aana iae EAERI Tosa 25 7 SPARES AND ANCILLARY SERVICES cccccccssseeceseseeeeeeseeeeeeeeeeeeeeeseeseeeseaeeeeesaeseenseaneeeeneaes 26 8 DISPOSAL lt a one al deci 27 8 1 Information on Disposal for Users of Waste Electrical amp Electronic Equipment excluding private households vs cms lat diet ae caerenes 27 8 2 Information on disposal in other countries outside the European Union
43. this table of normal values at any time by selecting the View Normal Values from the View menu located on the menu bar at the top left hand corner of the Control Panel window You can select the measurement which you would require for diagnostic comparison by checking the Print boxes next to the hot or cold threshold test of the individual measurement sites in Thermotactile Threshold Test window This enables you to select the appropriate threshold measurements which you will use for diagnostic comparison if you have performed and recorded repeats It is recommended that these Print boxes are checked while conducting the test or before saving a test for ease of reference if you decide to print at a much later point in time The boxes which were selected will be saved into the test record as well Document no TA 009 HVLab Thermal Aesthesiometer Page 20 of 29 Issue 6 0 Instructions for Use 08 03 10 HYLAB Diagnostic Instruments Thermotactile Threshold Test lol x File Edit View Tools Help ax x DOOR o FP Da 0 HVLab Thermotactile Threshold Test PERSONAL DETAILS Surname Subject Date of birth 0101 1960 Forenames Test Reference number TS1 TEST RESULTS Test date 31 01 2006 15 48 07 Room temperature 21 5 C Tester Administrator Finger skin temp left 31 7 C Finger skin temp right 32 4 C Measure Measurement Dysfunction Threshold Standard Criteria for dysfunction ments site C deviation C select
44. tions for Use 08 03 10 6 Warnings and Precautions 6 1 Handling and Storage When not in use the Thermal Aesthesiometer should be switched off using the power button on the front of the control box This will also remove power to the applicator Care should be given to the handling of the thermal aesthesiometer at all times particularly the applicator Dropping the applicator even a short distance may damage the applicator If the applicator is dropped proceed through calibration checks before the Thermal Aesthesiometer is used see section 5 The Thermal Aesthesiometer TA can be left connected to the computer whilst not in use 6 2 Precautions and contra indications Please ensure that before the Thermal Aesthesiometer is used on patients The TA is calibrated to the required standard and is functioning correctly see section 5 There is no obvious damage to the device The additional protective earth terminal is connected to earth via a mains power socket or a permanently connected protective earth conductor 6 3 Connection to external devices It is possible to connect external accelerometers or signal conditioning equipment to the HVLab Thermal Aesthesiometer Any equipment not supplied by the manufacturer above and connected to the device must satisfy the following criteria conform with or maintain the requirements of medical electrical devices according to ISO 60601 1 and any applicable part 2 be a type B device Th
45. urrent subject select Thermotactile Thresholds and click on View Test Results 4 2 Thermotactile Threshold Test Window The Thermotactile Threshold Test Window is divided into four sections Subject Details Test Parameters Test Details and Test Results 4 2 1 Subject Details The Subject Details section see Figure 4 shows the details of the current subject which cannot be edited here The new test record that will be created in the thermotactile test results database will be linked to this subject record Document no TA 009 HVLab Thermal Aesthesiometer Page 11 of 29 Issue 6 0 Instructions for Use 08 03 10 MM HYLAB Diagnostic Instruments Thermotactile Threshold Test File Edit View Tools Help Thermotactile Threshold Test Subject Number 1 Test Number fi Subject Details i Test Parameters GRADE Bse SS Parameter set name Default X _ Addnew Number of measurements 8 Edi Delete Forename Default Reference temperature 32 5 FE Increment rate 1 0 C second Test Order Decrement rate 1 0 C second Hot then Cold measurement Date of birth 01 01 1930 Ni Reference ps2 Number of reversals 6 Delay between reversals 3 seconds Temperature limits C Date of entity Ea Record probe temperature min 10 max 55 Test Details Test Results Room temperature 0 ec Measurement Hot threshold C _Cold threshold C Neutral FST Left fo site print
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