Home

Instructions for Use HVLab Multi

1. pr r Ifthis dialogue fails to close or if you wish 1 to cancel the date transfer select 1 Cancel Import frorn the File menu n E Start Figure 23 Waiting for data transfer question Are you sure you want to exit without saving Y N This is to ensure Cancel has not been pressed by mistake Once the number of measurements for the run is complete click Save to save the datafile You will be prompted to save the complete graph as an fbf file the software will automatically suggest a filename in the Data folder but you may choose a different filename and or location Figure 22 5 4 1 The Running Test and Importing Results dialogue 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 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 5 4 2 Repositioning the line cursor The line cursor can be repositioned immediately after the measurement has been recorded or in View mode Click once at either end of the line and drag the end of the line to the required point on the trace and release the mouse Do the same with the other end of the line cursor Click onc
2. 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 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 th
3. 5 HYLAB Diagnostic Instruments Finger Systolic Blood Pressure Test Eile Edit View Tools Help Subject Deta ils Surname Other Forename fAndiew Date of Birth proas ooo Reference No i2056 Date of Entry 217082005 oo Subject Number ja 7 Test Number j2 Parameter Set Name Defaut z Add New No of Measurements 4 E Edit Delete No of Measurement Sites 5 Inflation Pressure 250 mm Hg Deflation Rate 25 mm Hg second Cooling Period 30 seconds Finger Systolic Blood Pressures Room temperature 21 C Air Measurement jV r E r FST Left 34 C 2 c soc 15 e 10 c FST Right 34 C Reference s e Seha Test Date 270 2006 14 22 57 Jindex mm Hg Tester Administrator middie J mm Hg Data File No file selected fing eung Jittle mm Hg Grcacicscrk Fre ig Start Start Start Start Percentage Finger Systolic Blood Pressures Control Temperature O Oo index 0 0 0 0 middie 0 0 0 0 fring 0 0 a 0 itie 0 0 0 0 Notes Save and Exit Calibration Cancel Form View Figure 6 Finger Systolic Blood Pressure Test window opened by Start New Test button 4 2 2 1 Parameter Set Name The name of the current parameter set The parameter settings for the objective testing of finger systolic blood pressure for HAVS assessment is entitled default 4 2 2 2 Number of Measurements The number of mea
4. Plethysmograph Fault Detected x Fault interlock line low Please contact manufacturer Please contact manufacturer Click OK to display and download diagnostic information pe Figure 31 Plethysmograph Fault Detected Message 7 1 11 Protective earth lead The protective earth lead must be connected at all times for conformance with EN 60601 1 7 1 12 Strain gauge warning indicators The strain gauge indicators illuminate if a strain gauge has become faulty Remove the strain gauge from the patient as soon as possible For spillages of mercury and disposal of strain gauges refer to section 7 3 7 2 Software During the test please contact the manufacturer if the software produces any error messages e g Figure 31 Please take note of the details of the error message and then click OK to display and download diagnostic information The Diagnostic Information window Figure 32 will open and contain information on the status of the plethysmograph prior to the fault occuring Click Save to Clipboard to copy all the information provided and then paste this information into a text document e g Notepad in No of Measurements 4 i 960 Fault interlock line low a jo5 Please contact manufacturer DPE O P1 IPO VP 1 I P 2 P3 1P 4 P5 I P 6 P7 P8 P9 P10 MPTE HP Aa mm Hg C mmHg f w w w w w w w _ 40 00 250 00 21 54 181 75 0 02 1000 1000 0 31 0 01 0 13 1 33 1 38 1 23 1
5. Press the circulation failure button on the front of the Multi Channel Plethysmograph This can be pressed repeatedly If the circulation does not restart stop the measurement immediately by clicking Stop and Cancel in the finger systolic blood pressure measurement window Cancel will dump the pressure Remove the cuffs from the patient and switch off machine and mains power supply Please contact the manufacturer by telephone on 44 0 2380 592277 7 1 9 Water minimum and maximum indicators The water level should be illuminated up to a maximum of 5 green lights The minimum water level for finger systolic blood pressure testing is 2 green lights If only one water level light is illuminated green then operating the device may cause damage as this is below the minimum water level The top light should remain amber as this is above the maximum level If less than 2 lights are illuminated green add water using the Fill socket on the front of the Multi Channel Plethysmograph If the maximum light is green drain some water to the recommended level by using the Fill socket as well 7 1 10 Re settable fuses If a mains surge greater than 10 Amps has occurred the re settable fuses will unseat Switch off the Multi Channel Plethysmograph and the mains power supply Please contact the manufacturer by telephone on 44 0 2380 592277 Document number PG 009 HVLab Multi Channel Plethysmograph Page 43 of 53 Issue 9 0 Instructions for Use 01 10 10
6. The measurement of finger systolic blood pressure following arterial occlusion at one provocation temperature Finger systolic blood pressure test A set of finger systolic blood pressure measurements FSBP Record Finger systolic blood pressure test completed on a subject on a particular date stored in the HVLab Diagnostic Instruments Manager software Cooling Temperature provocation of the fingers with pressurised cuffs Finger blood flow The rate of arterial inflow in the finger Measurement The measurement of arterial inflow in the finger following venous occlusion Run A set of finger blood flow measurements that have had some measurements used to for the calculation of average finger blood flow FBF Record A set of FBF runs completed on a subject on a particular date stored in the HVLab Diagnostic Instruments Manager software Document number PG 009 HVLab Multi Channel Plethysmograph Page 51 of 53 Issue 9 0 Instructions for Use 01 10 10 12 Symbols used in labels and instructions on the HVLab Multi channel Plethysmograph and accessories Attention consult accompanying documents for important information Consult instructions for use for information Type BF Applied Parts Meets Type BF leakage current requirements of Clause 19 of IEC 60601 1 Protective Earth B h gt d Alternating Current Direct Current Temperature limitatione Humidity limitation Atmospheric pressure limitation Year of
7. at the base of the nail A good position can be achieved by bending the white connecting lead so that the gauge and first section of the lead is perpendicular to the finger Figure 2g Make sure that the lead will not be disturbed by any movement of the cuff or pipes during pressurisation Figure 2h The strain gauges must not be overstretched or twisted around the finger as this will limit the lifespan of the gauges and produce an inaccurate response Figure 2g The gauge should be perpendicular to the finger Once a strain gauge is correctly positioned hold it in place by sticking it to the dorsal side of the hand using micropore tape It may be easier to stick the micropore tape for the thumb strain gauge on the wrist Figure 2i Connect the strain gauge on the thumb to the first Transducer socket on the Plethysmograph front Figure 2h The completed setup panel and the gauges on the index middle ring and for FSBP measurements little fingers to sockets 2 3 4 and 5 respectively d The Cuffs and Gauges are now ready to make an FSBP measurement as described in Section 4 of this manual The water pipes should not touch the skin Avoid movement of the hand during the measurements Figure 2i The lead of the thumb strain gauge may be attached to the wrist Document number PG 009 HVLab Multi Channel Plethysmograph Page 14 of 53 Issue 9 0 Instructions for Use 01 10 10 Cuffs Connecting tubes Tape to
8. 0 Instructions for Use 01 10 10 4 5 Viewing Previously Collected Test RESUItS ccccccesseeeeeeeeeeeeeenteeeeeeeeteeeeenanees 25 4 5 1 Printing and expor NA o a ereen Ges pte eret eea ee Cocaine EE EEEE EE REAS 27 5 Running a finger blood flow teSt sssssssssssnnsnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn n 29 5 1 The Control Panel WiC OW sissiscscisctisneesursinceiierinceiornineiueesaiaaedsneeuneiiecaaninecaee eee 29 5 1 1 UINFSNSUDIOCL a c8 aed OS a ta OS et eA te 29 5 1 2 Diagnostic TeSt ce cide aii esau Kee ovine re ea ee ee eee RE 29 5 2 Finger Blood Flow Test WINdOWs sii345s natdis esdc deters aes ease eects 29 5 2 1 Subject Detalls srr a a a daaa tip 29 5 2 2 Test Parameters eenei narea eona eara EE AAA aa KEE EnA E EESE 29 5 2 9 LestidetallSinwecndconecuniine Giant a aN a A A ales 31 524 TestRes lts eit a aa e A a a a a E aa 32 5 2 5 Calibration Window ceececcceecc cece ee eeeeeeeeeeeeeeaaeeaaaeeeeeeeeesaaeeaeeeeeeeeeeeeaaeaneees 32 5 3 The Pressure and Control WinGOW 525 esas neuen eee a eee 32 5 4 The Finger Blood Flow Measurement Window eceeceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeerees 33 5 4 1 The Running Test and Importing Results dialogue nnn 35 5 4 2 Repositioning the line CUrSOM seeen 35 5 5 Viewing Previously Collected Test R Suis iic ccssecieeeictince isin eeeneieiehs 35 5 5 1 Finger Blood Flow Individual Measurements Window 0eeeeeeeeeees 37 5
9. 10 00 0 31 0 01 0 13 1 33 1 38 1 23 1 57 1 4 0 00 250 00 21 54 235 36 0 02 10 00 1000 0 31 0 01 0 13 1 33 1 38 1 23 1 57 1 4 em 10 00 250 00 21 53 238 25 0 02 10 00 10 00 0 31 0 01 0 13 1 33 1 38 1 23 1 57 4 a 4 Save to Clipboard r Figure 32 Diagnostic Information Window Document number PG 009 HVLab Multi Channel Plethysmograph Page 44 of 53 Issue 9 0 Instructions for Use 01 10 10 Windows OS Please provide this document to the manufacturer to assist in diagnosing the fault with your Multi Channel Plethysmograph 7 3 Handling and Storage 7 3 1 Multi Channel Plethysmograph Environmental conditions for transport and storage for the Multi Channel Plethysmograph are as follows 30 C Temperature range 5 C to 30 C 5C 85 Humidity range 45 to 85 A mii 45 106kPa Atmospheric pressure range 50kPa to 106kPa D 50kPa During transport the plethysmograph must be kept upright at all time The plethysmograph contains fragile glass components fragile on the inside and should not be exposed to any shocks or excessive vibrations Always drain the water from the plethysmograph prior to moving When not in use the Multi Channel Plethysmograph should be switched off using the power button on the front panel This will also remove power to the strain gauges The mains supply to the transformer should also be switched off The Multi Channel Plethysmograph can be left connected to the compute
10. 5 2 Printing and exporting saz iss ices As gach coegatsn scenes denpedandcngangs cotantae egenss ates Aeetee 37 Ge Maintenant eessen teuecevesivasenttvenceceSeevscestiveceussevascesiieeceustoevssebveenceeetevaxdesternce 38 6 1 Cleah 0 niea oP Nee PEPE OR EES Ea SAE EDK REPRE DK ERR ENR SER ETN PRET ste aaea EDP 38 6 2 Calibration 2 Adee Sound ie ioesas e E N Ta ede is as ee eae 39 6 3 Regular performance checks by the USED ceceeeee ieee teeta 39 6 4 Regular preventative inspections by the USef s 41 6 5 Faults and Repa S wesci sucess cindintin a borat aides a aa ESE 41 7 Warnings and Precautions ccccccccceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeneaeseeeeeeeeeeeeeaaeeneeeeeees 42 FAT SAQA WAC tot ace E ds a nace dec tela eta ataaia sens NE Lubes daa AT 42 7 1 1 Ambient temperature for normal USC cccccceeceeceeeeeeeeeeeeeeeeeeeeeeeseeeeseeeeeeeeees 42 7 1 2 Power On and Power Connected light c ccceeeeeeeeeeeeeeeeeneeeeeeeeeeeeeeeeaaees 42 7 1 3 Plethysmograph turned off unexpectedly cccceceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeaees 42 7 1 4 Pressure too high Indicators iccccneiezcsseisseteeeiex evneteservielsvevsevlaveteeesseeveeeveteens 42 7 1 5 Temperature too high tiGiCaton x sis faclenscszesseaeces dtanccesteheheasaiataeaseebeeesscdencteceene 43 7 1 6 Temperature too low indicator ccccceceeecceeeeeeeeeeeeeeeeeeaaeeeeeeeeeeeeeeaaeeetees 43 7 1 7 Bypass operational indicat
11. 57 1 4 0 00 250 00 21 54 184 66 0 02 10 00 10 00 O31 0 01 0 13 1 33 1 39 1 23 1 57 1 4 10 00 250 00 21 53 187 87 0 02 1000 1000 0 31 0 01 0 13 1 33 1 39 1 23 1 57 1 4 0 00 250 00 21 53 191 01 0 02 10 00 1000 O31 0 01 0 13 1 33 1 39 1 23 1 57 1 4 10 00 250 00 21 53 194 35 0 02 10 00 1000 0 31 0 01 0 13 1 33 1 39 1 23 1 56 1 4 0 00 250 00 21 53 196 93 0 02 10 00 10 00 0 31 0 01 0 13 1 33 1 39 1 23 1 57 1 4 40 00 250 00 21 54 199 72 0 02 10 00 1000 031 0 01 0 13 1 33 1 39 1 23 1 57 1 4 0 00 250 00 21 53 202 67 0 02 10 00 10 00 0 31 0 01 0 13 1 33 1 39 1 23 1 57 1 4 0 00 250 00 21 54 20598 0 02 10 00 1000 0 31 0 01 0 13 1 33 1 38 1 23 1 57 1 4 0 00 250 00 21 54 209 13 0 02 1000 10 00 0 31 0 01 0 13 1 33 1 39 1 23 1 57 1 4 0 00 250 00 21 54 21216 0 02 10 00 10 00 0 31 0 01 0 13 1 33 1 38 1 23 1 57 1 4 qoz 000 250 00 21 55 21483 0 02 10 00 10 00 0 31 0 01 0 13 1 33 1 38 1 23 1 57 1 4 40 00 250 00 21 55 217 76 0 02 10 00 1000 03 0 01 0 13 1 33 1 38 1 23 1 57 1 4 10 00 250 00 21 53 221 10 0 02 10 00 1000 0 31 0 01 0 13 1 33 1 38 1 23 1 57 1 4 ee 0 00 250 00 21 55 22364 0 02 1000 1000 0 31 0 01 0 13 1 33 1 38 1 23 1 57 1 4 id 0 00 250 00 21 54 226 79 0 02 10 00 1000 031 0 01 0 13 1 33 1 38 1 23 1 57 1 4 0 00 250 00 21 54 22964 0 02 10 00 10 00 0 31 0 01 0 13 1 33 1 38 1 23 1 57 1 4 0 00 250 00 21 54 232 60 0 02 10 00
12. C Pressure reduction rate Occlusion pressure during cooling Cooling period Finger Blood Flow Test Data sampling rate Number of test fingers Occlusion pressure Measurement time Number of measurements per run 2 2 Power requirements Isolation Transformer Input voltage 240V option Input voltage 100V option Input frequency Maximum input power Document number PG 009 Issue 9 0 01 10 10 HVLab Multi Channel Plethysmograph 0 4 to 4 0 mmHg per second 50 250 mmHg 30 600 seconds 10 readings per second 1 5 30 200 mmHg 5 20 seconds 1 10 220 to 250 V ac 94 to 106 Vac 50 60 Hz 1500 VA Page 6 of 53 Instructions for Use Plethysmograph Control Unit supplied from isolation transformer output Input voltage Input frequency Maximum input power 2 3 Technical specifications Ambient temperature for normal use Ambient temperature Air Pressurisation Maximum inflation pressure Over pressure safety limit Accuracy in pressure setting Accuracy of pressure indication in software Range of pressure indication on panel meter Accuracy of pressure indication on panel meter Accumulator charging rate Cuff inflation rate Water circulation and temperature control Flow rate Range of flow rate indication on panel meter Accuracy of flow rate indication on panel meter 110 55 0 55 V ac 50 60 Hz 1500 VA 15 25 C 250 mmHg 270 15 mmHg 10 mmHg 10 mmHg 0 500 mmHg 10 mmHg
13. E Ne Average Blood Inflow sec Room temperature 21 5 a gt Individual FST Left T F c Comments thumb index middle l ring little Data FST Right 34 C Run 1 _start_ open Test Date 12 01 2006 15 4559 Ganz _Start_ Open Tester Administrator Run 3 fy ff Start Open Data File peee Runa f _Stat_ open z cae Run 5 L fey ff Start Open Run as a simulation V Run amp lr E A A Start Open Run 7 fT fT fy Start Open Run 8 fr T f T f Start Open Run 3 Doo E a ee Start Open Run 10 pooo D T 0 E T Start Open Run 11 Ee ee Start Open Run 12 fey ff Start Open Run 13 ee ee ee ee Start Open Save and Exit Calibration Cancel Form View Figure 17 Finger Blood Flow Test window opened by Start New Test button 5 2 2 3 No of measurement sites The number of fingers where FBF will be measured 5 2 2 4 No of measurements per run The number of measurements in each run The database acquires the finger blood flow in the chosen number of measurements and calculates an average finger blood flow per run 5 2 2 5 Inflation Pressure The inflation pressure of the cuffs during occlusion 5 2 2 6 Pre inflation time The time between the start of the measurement and the onset of occlusion 5 2 2 7 Measurement time The duration of the pressurisation of the cuf
14. Entry esenea MumberijA0215 View Test Results Print All Records Date of Entry 31 August 2005 Gender s Male C Female Preferred Hand Ks Right Left Either Questionnaire View Full Details Add New Record Add New Subject Find Subject View Records Print All Records Curent User JAdiministyato User Details Log Off Exit Database Record 14 4 2 gt or gt of 19 Form View Figure 4 Control Panel window Document number PG 009 HVLab Multi Channel Plethysmograph Page 17 of 53 Issue 9 0 Instructions for Use 01 10 10 HY LAB Diagnostic Instruments frmSubjectDetails Form File Edit View Tools Help Subject Number 217 Surname Other Address Forename Andrew Reference Number 11203568 Date of Birth 13 October 1950 NI Number Gender Male x Report submitted to Height m 11 9 Weight kg 90 Preferred hand Right z Marital status Single z Appointment date ETE Time 09 34 Ethnic group European Entered by Administrator Date 31 08 2005 History of Missed last appointment on 10th November changes and other information Delete Subject Undo Changes Close Form View Figure 5 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 or manually enter data After entering or finding your subject o
15. Inflation Pressure 250 mm Hg Reference No frst Deflation Rate 25 mm Hg second Date of Entry 2070872005 sr Systolic Blood P Sere Test Details Plethysmograph On User Set Reset Amplifiers Addressing C off Room temperature o0 c Target Pressure co mmHg First Second Percentage Gauge FST Left I OE Compressor e m 200 Stage Stage Change Resistance 3 Off Amplifier 1 Amplifier Y2 Ohms FST Right 0 c v Set to Target C On Target Py PG Serial No Pressure Off Temperature C ie O08 oe 0 25 e Test Date 30 09 2010 14 03 28 a mets C On 100 00 0 31 Eraaton Off This performs a diagnostic test of the Tester Administrator A pressurisation system Data File No fie selected c Make sure the cuffs are disconnected from 100 00 0 30 i ee Inflation Valve y Open the plethysmograph before proceeding with the test foe Close The pressurisation test may take a few minutes ae Please click OK to proceed or CANCEL to exit 3 11 0 25 R imulation T Enable Deflation On sa ese Malye Gf canel 019 0 35 _ C Open Bump Sobran recs emm 140 01 R fie 1 1 R First stage amplifier gain 100 0 Second stage amplifier gain 10 0 Strain gauge current 50 0m4 z Control Word Return Word 00000100 C Hex 00111110 Exit Binary Save and Exit Calibration Cancel Figure 27 Pressurisation Test 6 2 Calibration All HVLab Diagnostic Instruments are calibrated and quality
16. Status and Action instructions and the Current and Target Inflation Pressure Pre inflation Time Measurement Time and Measurement Number indicators Figure 19 Precautions that should be taken to ensure reliable measurements are outlined in Section 6 4 of this manual Follow the instruction in the Action box and click Continue or use the footswitch for the next instruction to prepare for running a measurement The sequence of instructions is H Lab Finger Blood Flow Test Pressure and Temperature Control File Calibrate View Help Status Measurement 1 Action Position cuffs and strain gauges on fingers then Click Continue r Current p Target Inflation Pressure mm Hg Pre Inflation Time Seconds Measurement Time Seconds Measurement Number 1 I Simulated Test Continue or press footswitch Cancel Figure 19 Pressure and Temperature Control Window Document number PG 009 HVLab Multi Channel Plethysmograph Page 32 of 53 Issue 9 0 Instructions for Use 01 10 10 i Position cuffs and strain gauges on fingers then click Continue ii Click Continue to continue iii Please wait computing pressure decrement The Current box displays the current inflation pressure The Target column displays the target inflation pressure as set in the General Settings in the FBF Parameters Window As the actions are followed the current inflation pressure will change to match the target inflatio
17. Symbols used in labels and instructions on the HVLab Multi channel Plethysmograph and ACCOSSOPICS visi cnindeccsnescnncatnnaccdannsancinundensdasvaeusdnsnsensseanaeusiaccsantsnenaens 52 13 CE Declaration of Contorimityc ciccicisccccscccitictinstiettit ceeded ei on atilendde 53 Annexe A Installation of the USB 2527 computer interface ccccccceeeeseeeeeeeeeeeees 1 Annexe B Installing and setting up the software ccccceeeseeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeneees 1 B 1 Software installation options iiiciticinctos ccccccinhtats teste aot heats adh 1 B 2 Performing a TEW IWISLAllANON so Scoss2res eat trainee ceat ed elebephie a eiee es eee eae dee 1 B 3 Performing an installation over a distributed NEtWOFK ccccccececeeeeeeeeeeeeeeeeeeeeeeetees 2 Document number PG 009 HVLab Multi Channel Plethysmograph Page 4 of 53 Issue 9 0 Instructions for Use 01 10 10 1 System Information This manual was supplied with the following system Device HVLab Multi Channel Plethysmograph Model Number PG4 0 Manufacturer and Contact Details Human Factors Research Unit Institute of Sound and Vibration Research University of Southampton 0086 Highfield Southampton S017 1BJ United Kingdom Telephone 44 0 23 8059 2277 Fax 44 0 23 8059 2927 Email hvlab soton ac uk Document number PG 009 HVLab Multi Channel Plethysmograph Issue 9 0 Instructions for Use 01 10 10 Page 5 of 53 2 Product Specification The
18. classification Type of Protection against Electric shock Degree of Protection against Electric shock Classification according to the degree of protection against ingress of water Degree of safety of application in the presence of a Flammable Anaesthetic Mixture with Air or with Oxygen or Nitrous Oxide Class Ila active diagnostic medical device Class Type BF Not Protected IPX0O Equipment not suitable for use in the presence of flammable mixtures Mode of operation Continuous Document number PG 009 HVLab Multi Channel Plethysmograph Page 8 of 53 Issue 9 0 Instructions for Use 01 10 10 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 Multi Channel Plethysmograph Control Unit PowarOn On or ee _ co e Ea 3 Transducers Air Water moe fF ere ee TT TTT TTT THT Le eT TTT Figure 1 System components see Section 3 1 Document number PG 009 HVLab Multi Channel Plethysmograph Page 9 of 53 Issue 9 0 Instructions for Use 01 10 10 b Strain gauges c Air pressure cuff d Water cooled pressure cuffs e Isolation transformer and power cable f Additional protective earth cable g Footswitch h USB 2527 Computer Interface i USB Isolator for supplied USB 2527 Computer Interface j Computer Inter
19. hold strain gauges Strain gauges Air In gt Figure 3 Mounting pressure cuffs and strain gauges for finger blood flow measurements 3 4 2 Arrangement of pressure cuffs and strain gauges for FBF measurements a The arrangement of pressure cuffs and strain gauges for measurement of finger blood flow FBF on the five digits of one hand is similar to that for FSBP measurements However for FBF measurements all five cuffs are connected to the Air outlet and the water cooling circuit is not used see Figure 3 b Select the appropriate size pressure cuff for each of the test fingers See section 3 5 1b for selecting the correct cuff Cuffs placed too tightly around the fingers will inhibit blood flow when not pressurised and very loose cuffs will not completely occlude the arteries when they are pressurised It may be necessary to use a smaller cuff for the little finger Place the five cuffs in a row and link them with 15 cm lengths of tubing Push the tubing over the inlets on each side of the cuff so as to cover at least two barbs Push a 15 cm length of tubing onto the free inlet of each outer cuff Join one of the outer pieces of tube to the cross bar of the supplied T coupler Join the other piece of tube to the opposite end of the T coupler as shown in Figure 3 Push the free end of the 1m tube with non sealing plug on to the base outlet of the T coupler so as to cover at least two barbs Connect the plug
20. manufacture LaS Document number PG 009 HVLab Multi Channel Plethysmograph Page 52 of 53 Issue 9 0 Instructions for Use 01 10 10 13 CE Declaration of Conformity Southampton Institute of Sound and Vibration Research Declaration of Conformity to the Medical Device Directive 93 42 EEC as amended 2007 47 EC for HVLab Diagnostic Instruments Comprising e Vibrotactile Perception Meter e Thermal Aesthesiometer e Multi Channel Plethysmograph This is to certify that the class lla equipment specified above conforms to the above Directives as transposed into national regulations and statutes of the United Kingdom such compliance having been demonstrated via A Technical File compliant to Annex VI Compliance to the Essential Requirements Quality Assurance procedures in accordance with BS EN IS013485 Compliance to Annex VI and VII Product Quality Assurance The CE marking of product being subject to the achievement and maintenance of a Annex VI certification by British Standards Institution Notified Body Number 0086 located at Maylands Avenue Hemel Hempstead HP2 4SQ The devices do not include animal or human tissue or derivatives blood products products that would be considered to be medicinal products or phthalates as defined in annex clause 7 5 nor are such materials used during their manufacture This is to certify that the above statement is true and relates to product manufactured from this date 1U DL Name Profess
21. necessary 7 6 Obtaining reliable measurements In order to obtain repeatable measurements of finger systolic blood pressure and finger blood flow attention should be given to various factors these include 7 6 1 USB2527 Computer Interface If the USB2527 Computer Interface has been disconnected from the computer please check that the interface settings are correct see Annex A 7 6 2 Finger skin temperature Finger skin temperatures at the measurement locations should not be below 22 C 7 6 3 Previous exposure to vibration Exposure to vibration immediately prior to measurement of FSBP or FBF measurement might result in a temporary vasoconstriction 7 6 4 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 7 6 5 Previous exposure to vaso active substances and alcohol Exposure to vaso active substances e g caffeine medication might result in temporary vasoconstriction 7 6 6 Room temperature The diagnostic tests should be performed in a room temperature of 21 1 C For the FBF test in summer it may be necessary to increase the room temperature to the external Document number PG 009 HVLab Multi Channel Plethysmograph Page 46 of 53 Issue 9 0 Instructions for Use 01 10 10 temperature to avoid vasoconstriction The subject should not be exposed to perceptible air movement 7 6 7 P
22. pressure cuffs and strain gauges for FSBP measurement 13 3 4 2 Arrangement of pressure cuffs and strain gauges for FBF measurements 15 3 5 Disconnecting devices ANd shutting OWN eeeeceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeteteeeeeeeeeeeed 16 4 Running a finger systolic blood pressure teSt cece cn eee eee e eee e eee eeeeeeeeeeeeeeeeeee 17 47 The Control Panel WINdOW s 2asegstets cahevcts iarctees alee aeixtaci ine eiiaaie aiinivens 17 4 1 1 Current SUDISCU scien a set et e aa oh bee acts we A Sea he ua Rade sara 17 44 2 DiaQnOsuc Tests s vc s urinate eee les Me 18 4 2 Finger Systolic Blood Pressure Test WiINGOW ccccccccccceeeeeeeeeeeeeeeeeeeeeeeeteeettees 18 4 2 1 53 21 6 Bc re gt amen am et re ie ee ee Sere ane 18 4 2 2 Test Parameters cccccccccceccceeeeeeeeceeeeeeeeaaeeaeeeeeeeeeeeaaeaeeeeeeeeseeaaaaseseeeeees 18 4 235 Test detalls snra e ond eate dee a a en ieage E 21 424 Test ROSU S aee a a a a e Aaa ra A r Ea EA ORERE EEEE A Aien EET 21 4 2 5 Calibration WIndoW sorser a e aea ae 21 4 3 The Pressure and Control WINKOW riscitsvsss des cos bedednenisic pds hoot on bbe Alot 22 4 4 The Finger Systolic Blood Pressure Measurement Window cccccccceeecteeeeeeees 22 4 4 1 The Running Test and Importing Results dialogue eeeeeeeeeeeeeeeeeeeeeee 24 4 4 2 Repositioning the CUFSOT ennenen 25 Document number PG 009 HVLab Multi Channel Plethysmograph Page 2 of 53 Issue 9
23. ready for use Please refer to the troubleshooting guide if necessary DO NOT connect any items to the Plethysmograph that are not specified and labelled as part of the system 3 3 3 Avoiding interference between the Plethysmograph and other devices HVLab equipment complies with the requirements of EN 60601 1 2 2001 Electromagnetic compatibility Requirements and tests with respect to Electromagnetic immunity and Electromagnetic Emissions For further information see HVLab document number PG 008 standards applied to the HVLab Multi Channel Plethysmograph However the instruments contain sensitive circuits that can be affected by high intensity radiated and conducted electromagnetic energy and should not be operated close sources of radio frequency and microwave radiation such as e Wireless radio and cell phone transmitters e Television and Radio Receivers e Industrial equipment The Plethysmograph should not be installed in close proximity to very sensitive medical equipment so as to avoid the possibility of interference by emissions from the Plethysmograph or connected computers 3 4 Setting up the pressure cuffs and strain gauges The cuffs and gauges must be set up according to the following instructions in order to obtain optimum results Double inlet cuffs have been supplied with the HVLab Multi channel Plethysmograph The cuffs can be adapted for measurements in air using the sealed connector supplied with the system Thr
24. results When you start the HVLab Diagnostic Instruments Manager software the Control Panel window opens as shown in Figure 4 The window is divided into three 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 Clinical Information which launches a health surveillance information database where this has been provided Please see the accompanying HVLab Diagnostic Instruments Manager Database manual for more detailed instructions on operation of the database 4 1 The 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 into the database by clicking on Add New Subject to open the Subject Details window and complete the subject details fields Figure 5 After completing the necessary information click Save to save and return to the Control Panel 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 HY LAB Diagnostic Instruments Control Panel Eile Edit Yiew Tools Help Database Version 7 0 Subject Number jis Suanama ther Test Finger Systolic Blood Pressure Forename Andrew N Date of Birth Eee Start New Test Manual Data
25. rm Measurement 15 L B Measurement 16 P Measurement 17 B Close gt frije of 1 Figure 26 Individual measurements window Document number PG 009 HVLab Multi Channel Plethysmograph Page 37 of 53 Issue 9 0 Instructions for Use 01 10 10 6 Maintenance 6 1 Cleaning The outside case of HVLab Multi Channel Plethysmograph HVLab Multi Channel Plethysmograph cuffs and HVLab Multi Channel Plethysmograph strain gauges must be cleaned Table 1 shows the regularity of cleaning required and the cleaning substances to be used Table 1 Regularity of cleaning cleaning substances to be used and member of staff responsible for cleaning Regularity of Cleaning substances to Member of staff cleaning be used responsible for cleaning Outside case of HVLab Monthly Damp cloth with water Technician Multi Channel and fairy liquid detergent Plethysmograph HVLab Multi Channel After every use Alcohol wipe solution Technician Plethysmograph cuffs HVLab Multi Channel After every use Alcohol wipe solution Technician Plethysmograph strain gauges Isolation Transformer Monthly Alcohol wipe solution Technician Computer Interface Monthly Alcohol wipe solution Technician USB Isolator Monthly Alcohol wipe solution Technician To clean the outside case of the HVLab Multi Channel Plethysmograph dampen a clean cloth with a solution of water and fairy liquid detergent Wipe all four vertic
26. secure the cuff Push the 60cm length of tube with non sealing plug i e without a spring loaded valve onto the cuff inlet and connect the plug to the Air socket on the front panel of the Plethysmograph b The water cooled provocation cuffs are placed Figure 2b Mounting a green cuff on around the medial phalanges of the test fingers the middle finger Select the appropriate size double inlet cuff for each of the subject s fingers Cuffs placed tightly around the fingers will inhibit blood flow when not pressurised whereas very loose cuffs will not completely occlude the arteries when they are pressurised Figure 2b shows the selection of a green cuff for the left middle finger Ensure that the correct size has been selected for each finger It may be necessary to use a smaller cuff for the little finger as shown in Figure 2c Figure 2c It may be necessary to Place the four cuffs in a row and link them with use a smaller cuff for the little finger three pieces of 15 cm length tubing Push the tubing on to the inlets on each side of the cuff so as to cover at least two barbs Push the free end of a 60 cm length of tubing with a sealing plug i e with spring loaded valve onto the free socket of each outer cuff Connect one plug to the Water In socket on the front panel of the Plethysmograph and connect the other plug in the Water Out socket Place the cuffs around the medial phalanx of each test finger Figure 2d
27. successfully However if the software encountered any errors during this diagnostic test an error message e g in Figure 29 will pop up informing the user to contact the manufacturer Please advise the manufacturer of the details in the error message to assist the manufacturer in diagnosing the fault in the Multi Channel Plethysmograph There are no other checks that can be performed by persons other than the manufacturer or manufacturer s agent Target Temperature C nn i TEST FAILED Please Contact Manufacturer For a Pressure with inflation valve open is less than 50 percent of the pressure when closed Pressure with inflation valve dosed 220 0 mm Hg Pressure with inflation valve open 9 5 mm Hg w 0 04 R 1 0 05 100 i 0 054 First stage ge 1 0 01 R fie 1 412 R Figure 29 Pressurisation Test Error Message Document number PG 009 HVLab Multi Channel Plethysmograph Page 40 of 53 Issue 9 0 Instructions for Use 01 10 10 6 4 Regular preventative inspections by the user Each day before the instrument is used the user should check that water is not leaking from the instrument or connected cuffs and tubing Damaged cuffs and tubes should be replaced immediately None of the red indicator lights next to the strain gauge connectors should be lit this indicates that the adjacent strain gauge is open circuit and should be replaced immediately Also ensure that the protective ear
28. the drop down list in the Diagnostic Tests box and then click on View Test Results to display the Finger Systolic Blood Pressure Test window Figure 13 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 is more than one test record 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 If there is no data file name shown in the Test Details section an Open File dialogue window H LAB Diagnostic Instruments Finger Systolic Blood Pressure Test Eile Edit Yiew Tools Help Subject Number lair Test Number ps Surname Other oresiame ndew No of Measurements 4 No of Measurement Sites 5 Date of Birth 13 10 1950 z Inflation Pressure 250 mm Hg Reference No 11203568 Deflation Rate 2 mm Hg second Date of Entry fat 08 2005 Cooling Period 300 seconds Finger Systolic Blood Pressures Room temperature 21E Air Measurement Jy B a Li FST Left 34 C a 2c 20 c 15 e 10 E tori z ite FST Right Seu ie 22 i ize me ie ico mmHg Test Date 12701 2006 14 30 27 index 54 6 54 50 7 3936 mmHg Tester Administrator middie 85 7 85 7 80 3 60 6 mmHg Data File C HVLwin7 Data 11203568_1 fing 848 ED rer 61 7 mmHg 20106_02 pgm ittie 84 6 84 6 76 9 66 2 mmHg e emai view _ _view view vi
29. to the Computer Connect the transformer power cable to the power socket on the rear panel of the Connect the transformer to a mains 220 240v AC supply and switch on You should see a green power light rear panel of the Multi Channel Plethysmograph Connect the ring connector of the additional protective earth cable to the green earth terminal on the rear panel of the Multi Channel Plethysmograph by removing the binding post nut Put the ring connector through and then reassemble the binding post nut with a 2BA spanner 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 plug may be removed and the cable connected to a fixed and permanently installed Protective Earth Conductor The additional protective earth MUST be connected at all times when the system is in use for testing patients or experimental subjects Press the button marked On on the front of the Multi Channel Plethysmograph to switch on You should see the following e A green power light marked Power On on the front of the Multi Channel Plethysmograph Document number PG 009 HVLab Multi Channel Plethysmograph Page 11 of 53 Issue 9 0 Instructions for Use 01 10 10 e Green amber and red lights on the front of the multi channel plethysmograph indicating the water level Add water into the fill socket using the bypass tube and syringe Your HVLab Multi Channel Plethysmograph is now
30. 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 over a network must have full access rights to this location on the network Document number PG 009 HVLab Multi Channel Plethysmograph Page B2 Issue 9 0 Instructions for Use 01 10 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
31. written instructions so they are aware of what the test involves The subject should be informed that the strain gauges are very sensitive to movement and that moving the fingers during a measurement will cause the strain gauges to give a random signal and make the graph impossible to read Document number PG 009 HVLab Multi Channel Plethysmograph Page 47 of 53 Issue 9 0 Instructions for Use 01 10 10 8 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 e Strain gauges e Pressure cuffs e Sealed cuff connectors e Tubing We can also provide training calibration and auditing of the operation of all diagnostic instruments Please contact the manufacturer for a quotation Document number PG 009 HVLab Multi Channel Plethysmograph Page 48 of 53 Issue 9 0 Instructions for Use 01 10 10 9 Disposal 9 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 you
32. 2006 16 25 18 thumb Blood inflow 1 29 s index Blood inflow 0 18 s Volume middle Blood inflow 0 04 s ring Blood inflow 0 65 s little Blood inflow 0 10 s PP E 0 0 Measurement Time sec 5 0 Strain minimum 10 Strain maximum 40 7 Time minimum o0 Time maximum 5 Figure 25 Rescaling controls can be turned on via the View menu Document number PG 009 HVLab Multi Channel Plethysmograph Page 36 of 53 Issue 9 0 Instructions for Use 01 10 10 on View All to see all traces The position of the line cursor can be edited in View mode see 5 4 2 of this manual The scaling of the FBF 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 Figure 25 Always click on All to see all traces before Saving or Cancelling After the finger blood glow graph has been displayed click Cancel to return to the Finger Blood Flow Test screen without saving changes Click Save to save any changes and to update the Test Results table in the Finger Blood Flow Test Window 5 5 1 Finger Blood Flow Individual Measurements Window The Individual Measurements Window Figure 26 contains a table of the blood flow at each measur
33. 54 thumb index Volume By middle Bl ring E ie AH 1 0 df ee 0 0 Measurement Time sec 5 0 Status Running Measurement 1 of 3 Include in Average Ril ohms R2fohms Fi3 ohms R4fohms R5fohms Figure 20 The Finger Blood Flow Measurement Window Document number PG 009 HVLab Multi Channel Plethysmograph Page 33 of 53 Issue 9 0 Instructions for Use 01 10 10 H Lab Finger Blood Flow Measurement Plot Blood Flow File View Help Next Cancel Save H Lab Finger Blood Flov Simulated Measurement 3 0 SUBJECT Andrew N Other REFERENCE 11203568 Z DATE and TIME 13 Jul 2004 17 33 03 a a thumb Blood inflow 0 33 s index Blood inflow 0 35 s Volume l middle Blood inflow 0 41 s ring Blood inflow 0 35 s little Blood inflow 0 34 s 0 00000 A a 0 00000 Measurement Time sec 5 0 Status Display E dit Measurement 1 of 3 Include in Average Filfohms fo oo0 R2 ohms Jo ooo R3 ohms fo oo0 Ra4fohms Jo ooo RSfohms fo oca Figure 21 Results of finger blood flow measurement between the 1 and 2 seconds of the trace for each measurement location The line can be repositioned by the user see 5 4 1 of this manual The finger blood flow ml 100 ml sec is calculated from the percentage strain and is displayed for each measurement site Figure 20 To include the finger blood flow data from the current
34. Instructions for Use HVLab Multi Channel Plethysmograph Human Factors Research Unit Institute of Sound and Vibration Research University of Southampton Southampton S017 1BJ UK HVLab document number PG 009 Baie DRFWe Descipton Bare 1 0 13 05 07 006 Firstissueofmewmanual CHL photographs changed to VA from W 4 0 13 01 06 032 Improvement to cuff and gauge set up AJLW instructions and updated test instructions for v7 software 5 0 24 04 07 119 Addition of disposal information CHL Reference to BS ISO 14835 2 updated to latest version eo 0507107 136 Translation into taian w 7 0 27 02 09 230 Installation instructions updated for v8 YY eee ee Merereeniieoieme es 26 05 09 Clarification to recommendation for Pe in Liens frequorcaaton 08 03 10 Updated electrical safety information technical specifications figure for USB setup system information Annexe A and Annexe B Removed Annexe C 01 10 10 Updated PG version number added information on pressurisation test software errors and diagnostic information window updated CE declaration of conformit Document number PG 009 HVLab Multi Channel Plethysmograph Page 0 of 53 Issue 9 0 Instructions for Use 01 10 10 Multi Channel Plethysmograph Instructions for Use Document number PG 009 HVLab Multi Channel Plethysmograph Page 1 of 53 Issue 9 0 Instructions for Use 01 10 10 Table of Contents Table of Contents iivioreinceneieian tic etsneneter
35. Multi Channel Plethysmograph provides computer based measurement of finger systolic blood pressures FSBP following cold provocation of the fingers Finger systolic blood pressures measured at different temperatures can be used to detect problems in the vascular response to cold The Multi Channel Plethysmograph also provides the means for measurement of finger blood flow FBF using venous occlusion plethysmography Blood flow measured at sub diastolic occlusion pressure can be used to detect problems in the vascular response to vibration The system controls finger temperature by rapid heating and cooling of water flowing through specially designed pressure cuffs During FSBP and FBF tests the Plethysmograph is controlled by a personal computer The instrument is designed to operate in a laboratory or clinic where the air temperature can be controlled between specified limits All of the system components are suitable for use in the patient environment The Multi Channel Plethysmograph complies with BS ISO 14835 2 2005 Mechanical vibration and shock Cold provocation tests for the assessment of peripheral vascular function Part 2 Measurement and evaluation of finger systolic blood pressure 2 1 Test Parameters The ranges of the test parameters that can be selected in the software are as follows Finger Systolic Blood Pressure Test Data sampling rate 10 readings per second Number of test fingers 1 5 Temperature range 5 C to 35
36. air bubbles The water temperature is not reached Overheating Fault with cooling mechanism Check the fans are not covered Remove any possible heat sources One measurement site gives a straight line response or no response 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 Replace with a spare thermocouple if necessary get a message saying Plethysmograph is not responding The plethysmograph is not switched on The power supply is not connected The computer interface cables are damaged Check the plethysmograph is switched on and that the power supply is connected to the plethysmograph and the mains Check the computer interface cable connections at the plethysmograph and the computer Cuffs do not deflate Dump Valve problem Open to Calibrate screen and click on Dump Valve Off this will Open the dump valve and release the pressure Click again to close the dump valve If any of the above suggestions do not solve your problem please contact the manufacturer by telephone on 44 0 2380 592277 Document number PG 009 Issue 9 0 01 10 10 HVLab Multi Channel Plethysmograph Instructions for Use Page 50 of 53 11 Explanation of terms Finger systolic blood pressure The arterial blood pressure in the finger Finger systolic blood pressure measurement
37. al sides and the top of the HVLab Multi Channel Plethysmograph Ensure water does not enter the plethysmograph through air vents or transducer sockets To clean the HVLab Multi Channel Plethysmograph cuffs use an alcohol wipe to wipe all sides of each plethysmograph cuff used It is not necessary to dismantle the cuffs nor separate them from the set up for FSBP or FBF measurement Take care when cleaning the HVLab Multi Channel Plethysmograph strain gauges as the silastic loop of the strain gauges that goes round the finger and the link between the silastic loop and the cable is very fragile Ensure not to over stretch or pull at the fragile silastic loop Clean each used gauge individually by laying an alcohol wipe flat on a clean surface Lay the silastic loop of the strain gauge on the alcohol wipe Fold the alcohol wipe over the gauge so the silastic loop is encased then gently press on the alcohol wipe thereby cleaning the silastic loop and the link between the silastic loop and the cable Wipe the length of the cable of each plethysmograph gauge used Document number PG 009 HVLab Multi Channel Plethysmograph Page 38 of 53 Issue 9 0 Instructions for Use 01 10 10 Finger Systolic Blood Pressure Test Subject Number 7 3 Test Number frag __SubjectDeteils_ __ TestParameters Surname Subject Parameter Set Name Default Forename f No of Measurements 4 AAR No of Measurement Sites 5 Date of Birth 01 01 1960 4
38. ate 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 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 de
39. be edited here The new test record that will be created in the finger blood flow test results database will be linked to this subject record 5 2 2 Test Parameters The Test Parameters section shows parameters of the finger blood flow test measurements that will be performed in the current test These parameters may be altered from the default values by selecting different parameter sets using the Parameter Set 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 Editing and creating new test parameters below The Test Parameters section includes the following values 5 2 2 1 Parameter Set Name The name of the current parameter set 5 2 2 2 Number of Runs The number of runs to be completed in one test Document number PG 009 HVLab Multi Channel Plethysmograph Page 29 of 53 Issue 9 0 Instructions for Use 01 10 10 5 HYLAB Diagnostic Instruments Finger Blood Flow Test File Edit Yiew Tools Help Subject Number 27 Test Number 824 Surname Other Parameter Set Name Defaut z Add New No of Runs 20 Forename Andrew 2 Edit Delete No of Measurement Sites 5 H Date of Birth E 0 1950 No Measurements per Run 3 Inflation Pi z 60 Reference No 11203568 A E mtans COKE Pre Inflation Time 0 seconds Date of Entry fat 08 2005 Measurement Time 5 seconds J
40. cel Figure 7 Finger Systolic Blood Pressure Test Parameters Window Document number PG 009 HVLab Multi Channel Plethysmograph Page 20 of 53 Issue 9 0 Instructions for Use 01 10 10 4 2 3 Test details The Test Details section see Figure 6 includes values for Room Temperature and Finger Skin Temperature left and right 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 are entered manually are automatically imported if the tester has entered them in a previous test The test date field contains the test date and time and is entered automatically The Tester field can be used to identify the user who performed the test The Data File field is used by the software to store the name of the data file containing the FSBP graph data for the individual measurements Check Run as a simulation if you wish to run a simulated test without a subject for demonstration 4 2 4 Test Results The controls in this section allow you to start and repeat finger systolic blood pressure measurements N B If using a PCL 812 board before commencing a FSBP test set the switch on the distribution box to FSBP measurement There are two tables showing the test results The upper table shows the absolute finger systolic blood pressures for each measurement site at each measurement temperature The fields in the left column of the results table show the m
41. controlled prior to delivery A full calibration report is attached to this manual as Annexe 1 It is recommended that the system is re calibrated by the manufacturer or the manufactuer s agent at 12 monthly intervals and also if the equipment is moved to a new site Additionally regular performance checks should be carried out by the user as described in Section 6 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 6 3 Regular performance checks by the user During the pressurisation and cooling phase of each test see Section 4 3 the user should compare the pressure temperature and flow displays with those displayed on the controlling computer once a week to ensure that there is no discrepancy Each day before the instrument is used the user should also run a Plethysmograph Pressurisation Test Figure 27 which performs a diagnostic test of the pressurisation system in the plethysmograph Please make sure all the cuffs are DISCONNECTED from the Document number PG 009 HVLab Multi Channel Plethysmograph Page 39 of 53 Issue 9 0 Instructions for Use 01 10 10 Plethysmograph On User Set Addressing C Off Reset Amplifiers Target Pressure C On mmHg Fide Seron Percentage a Gauge Cc f
42. 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 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 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 PG 009 HVLab Multi Channel Plethysmograph Page B3 Issue 9 0 01 10 10 Instructions for Use
43. date 1201 2006 14 30 27 Room temperature 21 0 C Tester Adminis trator Finger skin tempileft 34 0 C Finger skin temp cright 34 0 C Measurement Dysfunction F SBP at15 FSBP at10 FSBP FSBP Criteria for site c c at 16 C at10 C dysfunction FSBP 15 C 10 C Possible Definite thumb 111 6 108 4 index o x 50 7 39 6 95 0 77 4 lt 80 lt 80 middle o x 80 3 60 6 95 1 737 lt 80 lt 60 ring o x 78 7 61 7 94 2 75 9 lt 80 lt 60 little o o 76 9 66 2 92 3 81 5 lt 80 lt 60 gt No dysfunction found Possible dysfunction Definite dys function NOTES TEST PARAMETERS Number of measurements 4 Deflation rate 2 5 mm Hg sec Number of measurement sites 5 Cooling period 300 sec Inflation pressure 260 mmHg Page A 1 Ie 4 Ready Figure 16 Previewing and printing a test report by clicking the Print Record button Click Save to save changes and exit the HVLab Finger Systolic Blood pressure Measurement window and return to the FSBP Test Results window Click Cancel to return via the Importing Measurement Results window see section 4 4 1 to the FSBP Test Results window without saving 4 5 1 Printing and exporting 4 5 1 1 FSBP graphs and data The finger systolic blood pressure graphs 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 FSBP data may also be exported to a text file by selecting Exp
44. e away from any trace to clear the cursor Do this for all traces as necessary Traces can be individually selected by clicking the matching coloured button in the key Click on All to see all traces N B Do not position the cursor so the FBF value is less than 0 01 5 5 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 Finger Blood Flow from the drop down list in the Diagnostic Tests box and then click on View Test Results to display the Finger Blood Flow Test window Figure 24 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 is more than one test record 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 Document number PG 009 HVLab Multi Channel Plethysmograph Page 35 of 53 Issue 9 0 Instructions for Use 01 10 10 H LAB Diagnostic Instruments Finger Blood Flow Test File Edit view Tools Help Subject Number 7 Test Number 817 p Subject Details Test Parameters Surname Othe irs nee No of Hebei me aa Date of Birth 13701950 No Measurements per Run 3 eae P orn Date of Entry fa 08 2005 Measurement aa 5 oe Fes Det
45. easurement sites that will be used The fields at the top of each column show the provocation temperature of the measurement Click on the Start button located underneath the measurement temperature you require to launch a finger systolic blood pressure measurement at the selected temperature Clicking on Start opens the Pressure and Temperature Control window which guides the user through the sequence of actions to prepare to perform a finger systolic blood pressure measurement N B You may briefly see the Transferring Measurement Results screen Please ignore this screen at this point It will automatically be hidden by the next window Go to the Pressure and Temperature Control window Section 4 3 of this manual for instructions on running finger systolic blood pressure measurement The lower table shows the FSBP for each measurement site at each measurement temperature The FSBP for each measurement site at each location is calculated automatically be the software Check the required Control Temperature to select the Control Temperature for the calculation of FSBPs The notes section enables the user to add any comments on the test if necessary When all the measurements have been completed click on the Save and Exit button 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 Test will return to the Control Panel window without sav
46. ee sizes of cuff have been supplied with the HVLab Multi Channel Plethysmograph The smallest cuffs coloured red and with a single groove around the middle the medium cuffs coloured green with two grooves around the middle and the large cuffs coloured yellow with three grooves around the middle Three sizes of strain gauges have been supplied with the HVLab Multi Channel Plethysmograph small coloured red medium coloured green and large coloured yellow Document number PG 009 HVLab Multi Channel Plethysmograph Page 12 of 53 Issue 9 0 Instructions for Use 01 10 10 3 4 1 Arrangement of pressure cuffs and strain gauges for FSBP measurement a The reference air cuff is placed on the proximal phalanx of the thumb on the hand to be tested If using the supplied rigid cuff select the correct size cuff to fit the thumb see b below and push a sealed cuff connector onto one of the two inlets Push the free end of a 60cm length of tube with non sealing plug i e without a spring loaded valve onto the second cuff inlet The tube should cover at least two of the barbs on the inlet Connect the plug to the Air socket on the front panel of the Plethysmograph Figure 2a Mounting a soft plastic reference cuff on the thumb If using a soft plastic air cuff instead of the provided double inlet cuff Figure 2a wrap the cuff around the finger so that it fits comfortably without applying pressure to the skin Use the Velcro strip to
47. ement location at each measurement during the run If the measurement has been included in the average the Enabled box will be checked To include measurements in the average blood inflow for the run return to the Finger Blood Flow Test window and view the graph of the required measurement Return to the Finger Blood Flow Test window in View mode by clicking Close 5 5 2 Printing and exporting The finger blood flow graphs 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 FBF run averages and individual measurement data may also be exported to a text file by selecting Export Results from the File Menu HY LAB Diagnostic Instruments Finger Blood Flow Test Individual Measurements File Edit view Tools Help Subject Number Eq Test Number 830 kami Average Blood Inflow sec Comments Digit thumb index midde tng ile Enabled Measurement 1 1 287 0133 0055 06 0124 v Measurement 2 L i r Measurement 3 O a si Measurement 4 B Measurement 5 e Measurement 6 z r Measurement 7 E Measurement 8 HE E Measurement 9 r Measurement 10 L B Measurement 11 l I E Measurement 12 E Measurement 13 a i Measurement 14 l
48. en 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 nothing 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 number PG 009 HVLab Multi Channel Plethysmograph Page A1 Issue 9 0 01 10 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
49. ercury into the same bag Handle the mercury carefully Wear rubber gloves and scoop it onto a sheet of paper or suck it up with an eyedropper The scoop paper or eyedropper should also be bagged and disposed properly according to guidance provided by environmental officials or your local health department If possible ventilate the room to the outside and use fans for a minimum of one hour to speed the ventilation Wash the patients and the operator s hands thoroughly with soap and water Pressure cuffs contain latex however under normal use the latex does not come into contact with the skin of the patient or operator In the even of a breakage remove the pressure cuff from the finger and dispose according to local environmental health guidelines 7 5 Precautions and contra indications Please ensure that before the Multi Channel Plethysmograph is used on patients The Multi Channel Plethysmograph is calibrated to the required standard and is functioning correctly see section 6 2 There is no obvious damage to the device the strain gauges or pressure cuffs The additional protective earth terminal should be connected to earth via a mains power socket or a permanently connected protective earth conductor Patients must complete a medical questionnaire prior to testing to ensure they do not have a medical condition that could be aggravated by cold provocation e g cardiovascular problems Seek medical advice before commencing the test if
50. ers A Blood Inflow sec oom temperature aera eel anor oa R See uy Comments tume index miade ino We Individual FST Rih 0 C Runt 130 0163 0053 0684 0105 View Open Test Date 07 12 2005 01512 Run 2 COCO TT C C TO m Tester Administrator Run 3 ff W f View Open Data File g HV WZreaND aN 120356 Run 4 ae ae a R iew Open Run 5 View Open Run as a simulation M Run 6 l rf YY Tf View ape Run 7 o C T fT T View Open Run 8 I TT g Y fT j View Open Run 9 l ff fT View Open Run 10 o C ff ff View Open Run 11 Sis TTT View Open Run 12 ff yf T View Open os OI TTT View Open Save and Exit Print Record Record a 4 2 gt cn ea of 4 Form View Figure 24 Finger Blood Flow Test window opened by View Test Results button Click each View button to display the individual finger blood flow graphs for each measurement which are saved in the Data File shown in the Test Details section Click Individual Measurements to view the Individual Measurements Window for a particular run Traces can be individually viewed by clicking the matching coloured button in the key Click H Lab Finger Blood Flow Measurement Plot Blood Flow File View Help Start Stop fi HYLab Finger Blood Flov Simulated Measurement 40 fo 71 SUBJECT Andrew Other a gt REFERENCE 11203568 DATE and TIME 12 Jan
51. ew Percentage Finger Systolic Blood Pressures Control Temperature O Oo ie index 100 Em Em ma middie 100 95 74 Z fring 100 94 76 z ittie 100 92 82 z Save and Exit Print Record Cancel Record 1 4 1 gt rt gt of 5 Form View Figure 13 FSBP Test window opened by View Test Results button Document number PG 009 HVLab Multi Channel Plethysmograph Page 25 of 53 Issue 9 0 Instructions for Use 01 10 10 H Lab Finger Systolic Blood Pressure Measurement P File View Help Start Stop Cancel Save FSBP Measurement 1 Air measurement Simulation SUBJECT Andrew Other REFERENCE 11203568 DATE and TIME 12Jan 2006 14 27 16 thumb Pressure 112 8 mm Ha Strain 27 3 index Pressure 54 6 mmHg Strain 72 5 middle Pressure 85 7 mm Hg Strain 51 3 Strain ring Pressure 84 8 mm Hg Strain 67 0 little Pressure 84 6 mm Hg Strain 12 3 an 260 Cuff Pressure mm Hg 20 Strain minimum l Strain maximum Cuff Pressure maximum 269 0 Cuff Pressure minimum 299 90 0 25 700 3 Figure 14 Rescaling controls can be turned on via the View menu will appear in which you can relocate the correct file Click each View button to display the individual finger systolic blood pressure graphs for each measurement in
52. face Cables k Bypass tube and filler not shown in Figure 1 3 2 Panel displays 3 2 1 Front panel On the left of the front panel are warning lights indicating Pressure too high Temperature too high Temperature too low Bypass operational and Circulation Failure see Section 7 1 of this manual At the top of the panel are the Power On power indicator light green On switch and red Off switch Press the green On Switch to power the Multi Channel Plethysmograph Press the red Off Switch to switch off the plethysmograph The Temperature gauge displays the water temperature in the water cuffs during a finger systolic blood pressure test The Pressure gauge displays the pressure in all cuffs The Flow gauge displays the rate of flow of the water in the water cuffs during a finger systolic blood pressure test On the right is a set of lights that indicate the Water level The minimum and maximum water levels are marked see section 7 1 of this manual A red or amber light indicates no water and a green light indicates water A socket above the water level indicators enables the user to add water or remove water using the Bypass tube There are 5 Transducers sockets for strain gauge inputs A red warning light illuminates if a strain gauge is broken see section 7 1 of this manual The Air socket is used to plug in the air cuff during the finger systolic blood pressure test or to attach the loop of air cuffs during a finger blood flow tes
53. faults 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 User 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
54. from the main unit Then open the one way valves in the connectors by pressing the tube ends inwards to release the pressure Please take care to contain any water that will spill from the tubes Click OK to continue to download the diagnostic information see 7 2 for further instructions and contact the manufacturer 7 1 4 Pressure too high indicator If the pressure too high light becomes illuminated Stop the measurement immediately by clicking Stop and Cancel in the finger systolic blood pressure measurement window or finger blood flow measurement window Cancel will dump the pressure Remove the cuffs from the patient and switch off machine and mains power supply Please contact the manufacturer by telephone on 44 0 2380 592277 Plethysmograph Fault Detecte x Plethysmograph turned off unexpectedly or system power failure Release any residual cuff pressure by disconnecting the tubes to the AIR and WATER cuffs and opening the one way valves in the connectors by pressing the tube ends inwards taking care to contain any water that spills from the tubes Please contact manufacturer Please contact manufacturer Click OK to display and download diagnostic information B Figure 30 Plethysmograph Fault Detected Message Document number PG 009 HVLab Multi Channel Plethysmograph Page 42 of 53 Issue 9 0 Instructions for Use 01 10 10 7 1 5 Temperature too high indicator If the temperature too high light becomes
55. fs whilst finger blood flow is being measured 5 2 2 8 Editing and creating new test parameters To create a new set of test parameters click on the Add New button to open the FBF Test Parameters window Figure 18 This contains three sections Parameter Set General Settings and Settings for Individual Measurement Sites Document number PG 009 HVLab Multi Channel Plethysmograph Page 30 of 53 Issue 9 0 Instructions for Use 01 10 10 Finger Blood Flow Test Parameters _ j IE No of Runs EEN User Name Administrator No of Measurement Sites 5 m Parameter Set Name Default Number of Measurements per Run 3 er k Inflation Pressure mm Hg 60 zat Nparuromoni CAERA Pre Inflation Time seconds 0 1 males thumb Measurement Time seconds 5 St Save Delete Cancel Figure 18 Finger Blood Flow Test Parameters Window To define a unique parameter set alter the values within the General Settings section see 4 2 2 1 to 4 2 2 7 for definitions of parameter settings The Settings for Individual Measurement Sites allows you to define the location of each of the measurement sites Select the measurement number 1 and type in the site name Click by the measurement site number to progress to the next measurement site Add the site name etc Repeat until all measurement sites have the correct location If a measurement site is not being used e g you are only measuring on four f
56. gt 20 mmHg per second gt 250 mmHg per second 2 15 ml per second 0 16 7 ml per second 0 1 I per min 10 of reading Range of temperature control 10 35 C Lower temperature safety limit 5 5 1 5 C Upper temperature safety limit 47 5 1 5 C Accuracy in temperature setting 1 C Accuracy of temperature indication in software 1 C Range of temperature indication on panel meter 0 50 C Accuracy of temperature indication on panel meter 1 C Temperature variation between cuffs lt 0 5 C Time to cool from 30 C to 10 C lt 3 minutes Estimated cooling efficiency 25 Strain gauges 10 readings per second per channel 0 04 0 90 10 of reading Data sampling rate Range of gauge resistance Accuracy of strain measurements in software Dimensions Control unit Height 1034 mm length 492 mm width 552 mm weight 80 9 kg Document number PG 009 Issue 9 0 01 10 10 HVLab Multi Channel Plethysmograph Instructions for Use Page 7 of 53 Isolation transformer Height 273 mm length 240 mm width 198 mm weight 15 5 kg Compliance with standards EN 60601 1 2006 Medical electrical equipment Part 1 General requirements for basic safety and essential performance ISO 14835 2 2005 Mechanical vibration and shock Cold provocation tests for the assessment of peripheral vascular function Part 2 Measurement and evaluation of finger systolic blood pressure 2 4 Equipment Classification Medical equipment
57. he Action box and click Continue or use the footswitch for the next instruction to prepare for running a measurement The series of instructions are i Click Continue to pressurise the accumulator ii Pressurising accumulator please wait iii Place cuffs and gauges on fingers then click Continue iv Squeeze fingers then click continue to inflate cuffs v Remove squeezer and wait for the cooling to elapse The Current column displays the current state of the parameter settings The Target column displays the target parameter settings as set in the General Settings in the FSBP Parameters Window As the actions are followed the current settings will change to match the target settings Once the preparation instructions are complete the Finger Systolic Blood Pressure Measurement Window Figure 9 will open automatically and the pressure in the cuffs will start to release IMPORTANT If the plethysmograph has been turned off unexpectedly or if there is a system power failure there will be an error message Figure 30 informing you that there is residual pressure in the cuffs which will prevent you from being able to remove the cuffs from the subject s fingers Please see section 7 1 3 for further information 4 4 The Finger Systolic Blood Pressure Measurement Window At the top of the screen are the buttons to Start Stop Cancel or Save the current measurement The name and reference number of the current
58. illuminated stop the measurement immediately by clicking Stop and Cancel in the finger systolic blood pressure measurement window Cancel will dump the pressure Remove the cuffs from the patient and switch off machine and mains power supply Please contact the manufacturer by telephone on 44 0 2380 592277 7 1 6 Temperature too low indicator If the temperature too low light becomes illuminated stop the measurement immediately by clicking Stop and Cancel in the finger systolic blood pressure measurement window Cancel will dump the pressure Remove the cuffs from the patient and switch off machine and mains power supply Please contact the manufacturer by telephone on 44 0 2380 592277 7 1 7 Bypass operational indicator The bypass is open and the light will be illuminated until pressurisation If the bypass light becomes illuminated during pressurisation a circulation failure may have occurred Complete procedures in section 7 1 5 If there is no circulation failure stop the measurement immediately by clicking Stop and Cancel in the finger systolic blood pressure measurement window Cancel will dump the pressure Remove the cuffs from the patient and switch off machine and mains power supply Please contact the manufacturer by telephone on 44 0 2380 592277 7 1 8 Circulation Failure indicator Check the tubing between the pressure cuffs is not kinked and is stopping the flow Give the tubing a wiggle to dislodge any air bubbles
59. ing the test results 4 2 5 Calibration Window The Calibration Window provides a means for the technician to control the Multi Channel Plethysmograph during calibration and is not required for diagnostic testing Calibration should only be performed by a certified HVLab technician Document number PG 009 HVLab Multi Channel Plethysmograph Page 21 of 53 Issue 9 0 Instructions for Use 01 10 10 w H VLab Finger Systolic Blood Pressure Pressure and Temperature Control E3 Test View Help Status Measurement 1 air measurement do not use cooled cuffs Action Click Continue to pressurise accumulator Current i Target i jaso mm Hg Cuff Temperature j22 C fs Seconds Inflation Pressure Cooling Period F Air Measurement I Simulated Test I Manual Deflate Continue or press footswitch Cancel Figure 8 Pressure and Temperature Control Window 4 3 The Pressure and Control Window The Pressure and Control window contains the Status and Action instructions and the Current and Target Inflation Pressure Cuff Temperature and Cooling Period indicators Figure 8 The number of the current measurement is shown in the Status box The air measurement box simulated test box or manual deflate box may be checked these indicate the type of measurement being conducted Precautions that should be taken to ensure reliable measurements are outlined in Section 6 4 of this manual Follow the instruction in t
60. ingers delete any wording in the Digit box Once you have finished defining your parameters label the parameter set in the Parameter Set Name field and click on Save To edit the parameters in the currently selected Parameter Set select the required parameter set click on Edit Delete in the Finger Blood Flow Test window change the desired parameter and then click on Save Change If Cancel is clicked the screen will return to the test window The existing parameter set can be used If this parameter set is not the required parameter set click Cancel again to return to the Control panel and re enter the Test window It should be noted that any alterations to the test parameters may affect the finger blood flow measures obtained 5 2 3 Test details The Test Details section see Figure 17 includes values for Room Temperature Finger Skin Temperature left and right 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 are entered manually are automatically imported if the tester has entered them in a previous test The test date and time will be added automatically The Tester field can be used to identify the user who performed the test The Data File field is used by the software to store the name of the data file containing the FBF graph data for the individual measurements Check Run as a simulation if you wish to run a simulated test
61. ion 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 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 Reader AdbeRdr910_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 PG 009 HVLab Multi Channel Plethysmograph Page B1 Issue 9 0 Instructions for Use 01 10 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 Certific
62. ket on the Plethysmograph front panel and the gauges on the index middle ring and little fingers to sockets 2 3 4 and 5 respectively The Cuffs and Gauges are now ready to make an FBF measurement as described in Section 5 of this manual 3 5 Disconnecting devices and shutting down After the tests have completed the HVLab Multi channel Plethysmograph can be shut down by pressing on the Off switch The plethysmograph must be shut down before disconnecting the Isolation Transformer plug the additional earth plug cable and the Computer Interface cable Strain gauges the plugs to the Air socket and the plugs to the Water In or Water Out sockets can be disconnected at any time It is also advisable to disconnect the water cooled provocation cuffs over a sink as there will be excess water within the tubes and the cuffs Document number PG 009 HVLab Multi Channel Plethysmograph Page 16 of 53 Issue 9 0 Instructions for Use 01 10 10 4 Running a finger systolic blood pressure test Before running a test the user is advised to carry out the cleaning and performance checks specified in Sections 6 1 and 6 3 respectively Finger systolic blood pressure measurements are controlled from the HVLab Diagnostic Instruments Manager software The Diagnostic Instruments Manager programme integrates the software that controls the Multi Channel Plethysmograph and other HVLab diagnostic instruments with a relational database of subjects patients and test
63. lood pressure data file the first pulse is observed The cursor can be repositioned by the user see 4 4 2 of this manual Cursor positions can be changed immediately after the data has been collected or at a later date The percentage strain and finger systolic blood pressure are displayed for each measurement site Figure 10 Click Restart to if you need to run the current FSBP measurement again check guidelines for repeating cold provocation stimuli Click Save to save the datafile You will be prompted to save the complete graph as a pgm file the software will automatically suggest a filename in the Data folder but you may choose a different filename and or location Figure 11 The FSBP test results will be transferred automatically to the database and displayed in the relevant fields The Importing Measurement Results dialogue is shown while the results are being transferred Figure 12 This process can take several seconds See section 4 4 1 4 4 1 The Running Test and Importing Results dialogue 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 Edit Delete Running Test and Importing Results Ded Waiting for data transfer weej The database is waiting fo the testto finish and for saved or updated results to be transferred to
64. measurement in the average blood inflow for the run check the Include in Average box in the graph window If the data should not be included in the average uncheck the Include in average box The measurements from each measurement site are averaged and displayed in the test results table in the Test Window Click Start to run the next FBF measurement in the run The test can be interrupted at any time by clicking on Stop By then clicking on Cancel the user will required to answer the Savein SQE5 H ml al ce 11203568_130704_00 fbf e MTOF_4 fbf MT125F_4 fbf a 11203568_130704_01 fbf aa MTOP_2 fbf a MT125P_1 fbf 11203568_130704_02 fbf aa MTOP_3 fbf MT125P_2 fbf a 11203568_200704_00 fbf se MT125F_1 fbf a MT125P_3 fbf a MTOF_2 fbf a MT125F_2 fbf a MT125P_4 fbf a MTOF_3 fbf a MT125F_3 fbf MT16F_1 fbf File name i EZEN Save as type FEF Files FBF Cancel I Open as read only Z Figure 22 Dialogue for saving finger blood flow data file Document number PG 009 HVLab Multi Channel Plethysmograph Page 34 of 53 Issue 9 0 Instructions for Use 01 10 10 Edit Delete Ded Waiting for data transfer weej The database is waiting fo the testto finish and for saved or updated results to be transferred to the database this may take up to 10 seconds to complete This window sultd will close automatically when the data have i been imported
65. ment Sites allows you to define the site of each of the measurement sites Specify the location for each measurement site by selecting the measurement number then type the name of the site required for that measurement To move to the next measurement site click Set the location for each measurement site If a measurement site is not being used e g you are only measuring on four fingers delete any wording in the Site and Details boxes this will ensure the report does not contain extra sites that have not been tested on Once you have finished defining your parameters label the parameter set in the Parameter Set Name field and click on Save To edit the parameters in the currently selected Parameter Set click on Edit Delete in the Finger Systolic Blood Pressure Test window change the desired parameter and then click on Save Change It should be noted that any alterations to the test parameters might affect the finger systolic blood pressures obtained Finger Systolic Blood Pressure Test Parameters E No of Measurements 4 User Name Administrator No of Measurement Sites 5 Parameter Set Name Default Inflation Pressure mm Hg a A Deflation Rate mm Hg s 2 Cooling Period s 300 4 Sd Measurement Sies Measurement Temperature Air Measurement site no C measurement number Site Details 1 22 0 Vv 1 thumb Air Reference Site Save Delete Can
66. n pressure Once the preparatory actions are complete the Finger Blood Flow Measurement window Figure 20 will open automatically IMPORTANT If the plethysmograph has been turned off unexpectedly or if there is a system power failure there will be an error message Figure 30 informing you that there is residual pressure in the cuffs which will prevent you from being able to remove the cuffs from the subject s fingers Please see section 7 1 3 for further information 5 4 The Finger Blood Flow Measurement Window At the top of the screen are the buttons to Start Stop Cancel or Save the current measurement Click Start to begin cuff inflation The name and reference number of the current subject and the date of test are displayed To the right the key for each gauge is displayed At the bottom of the screen are displayed the Status Inflation Pressure mm Hg and Inflation duration s of the current measurement and the resistance of each strain gauge The Include in Average box is also displayed At each measurement the percentage strain of the strain gauge at each measurement site is measured and displayed in real time on a graph Figure 20 Once the measurement is complete the software automatically places a line on the graph Eile View Help Start Stop Cancel Save H Lab Finger Blood Flov Simulated Measurement 35 SUBJECT Andrew Other _ ___ REFERENCE 11203568 DATE and TIME 12 Jan 2006 15 46
67. ontrolled from the HVLab Diagnostic Instruments Manager software The Diagnostic Instruments Manager programme integrates the software that controls the Multi Channel Plethysmograph and other HVLab diagnostic instruments with a relational database of subjects patients and test results When you start the HVLab Diagnostic Instruments Manager software the Control Panel window opens as shown in Figure 2 The window is divided into three 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 Clinical Information which launches a health surveillance information database where this has been provided 5 1 The Control Panel Window See section 4 1 5 1 1 Current Subject See section 4 1 1 5 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 Finger Blood Flow in the Test list box Click on Start New Test to open the Finger Blood Flow Test window To retrieve the results of existing tests on the current subject select Finger Blood Flow and click on View Test Results 5 2 Finger Blood Flow Test Window 5 2 1 Subject Details The Subject Details section see Figure 17 shows the details of the current subject which cannot
68. or ccccccccccceeeeeeeeeeeeeeeaeeeeeeeeeeeeeeeeaaeaseeeeeeeeeeeas 43 7 1 8 Circulation Failure indicator cccccccceceeeeecceeeeeeeeeeeeeeeeeeaaeeaeeeeeeeeeeeeaaeeneees 43 7 1 9 Water minimum and maximum indicators cece cece cette eee eeeeeeeeeeeeeeeees 43 7 1 10 Re Settable fuses 20 0 cccccccccceceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeseeeeeeeeesseeeegs 43 Document number PG 009 HVLab Multi Channel Plethysmograph Page 3 of 53 Issue 9 0 Instructions for Use 01 10 10 GALT Protective earth lead sic re ee ee EAE oe oe ee eS Te 44 7 1 12 Strain gauge warning indicators s siie oe codices evened Hes cee iens eens eneeeseeeveens neers 44 Ta SOWA e ae e vate aaa E a eck aan eve as O ten E E E RE 44 7 3 Handling and Storag ienr arenan i E AA a EA o A ARAA EEA ERR 45 7 3 1 Multi Channel Plethysmograph ccccccceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeees 45 T2 lt ACCOSSONESS nnna nan aa ian usen hoa eaten ean tk antes 45 724 DISPOSAL OR GECESSONCS ivi sis cistaceixtes wceeacelaceeviasncveuceiactanes E GE CR EEOAE 45 7 5 Precautions and Contra indiCatiOns ccccccccccssteeeeeeeeeeeecceaseeeeeeeeeseeeeaaaeeseteeseess 46 7 6 Obtaining reliable measurements cecucoen en ede Ganda bees 46 7 6 1 USB2527 Computer Interface cccccccccccccceceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeegs 46 7 6 2 Finger Skin temp rature ise aed arnir chased Re 46 7 6 3 Previous exposure to
69. or M J Griffin Position General Manager Date 30 June 2010 for and on behalf of the Human Factors Research Unit being a duly authorised officer of the company Signed Human Factors Research Unit Institute of Sound and Vibration Research University of Southampton Highfield Campus Southampton R Tan QUEEN S NNIVERSARY PRIZES S017 1BJ United Kingdom a Seana Tel 44 0 23 8059 2277 Fax 44 0 23 8059 2927 www isvr soton ac uk 2005 Document number PG 009 HVLab Multi Channel Plethysmograph Page 53 of 53 Issue 9 0 Instructions for Use 01 10 10 Annexe A Installation of the USB 2527 computer interface A PC which is to be connected to one or more HVLab Diagnostic Instruments must first be installed with a USB 2527 computer interface board according to the instructions below i ii iii iv v vi vii viii 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
70. ort Results from the File Menu Figure 14 Check the information that is required and click Export to File The Save As dialogue box will appear Enter the file name where indicated and select the required file location Click Save to save data or Cancel to return to the graphs After the finger systolic blood pressure graph has been displayed click Cancel to return to the Finger Systolic Blood Pressure Test screen without saving changes Click Save to save any changes and to update the Test Results table in the Finger Systolic Blood Pressure Test Window 4 5 1 2 Printing test reports A test report of the test record that is stored in the database can also be previewed and printed see Figure 16 from the Finger Systolic Blood Pressure Test Window Figure 13 by selecting the required test record and clicking the Print Record button at the bottom of the window Document number PG 009 HVLab Multi Channel Plethysmograph Page 27 of 53 Issue 9 0 Instructions for Use 01 10 10 The Starting Page Number window will open Please enter the first page number required for the report Click Close to exit the print preview Document number PG 009 HVLab Multi Channel Plethysmograph Page 28 of 53 Issue 9 0 Instructions for Use 01 10 10 5 Running a finger blood flow test Before running a test the user is advised to carry out the cleaning and performance checks specified in Sections 6 1 and 6 3 respectively Finger blood flow measurements are c
71. osture It is recommended that the hand is supported at the height of the hand to avoid pooling of the blood in the fingers This is most easily achieved by the subject being supine or seated If measuring on both hands ensure both hands and the arm if necessary are supported Moving the height of the hand relative to the heart can affect the blood flow reading this can be a way of improving the quality of the blood flow measurement 7 6 8 Size of strain gauges and pressure cuffs Ensure that the strain gauges do not overly indent the finger as this can restrict blood flow If the strain gauges are too loose small increases in strain will not be measured Pressure cuffs should not be too tight or the blood supply could be restricted If pressure cuffs are too loose the required inflation pressure may not be achieved and the cuffs may burst 7 6 9 Position of strain gauges Ensure that the strain gauges are not resting on the tubing that links the pressure cuffs as this can cause the strain gauges to move when the cuffs are inflated For FBF measurement a good guide is to take a few readings prior to testing to ensure that the gauges are giving consistent measurements Moving the location of the cuff and the gauge on the finger can give better more reliable results 7 6 10 Instructions to subjects All subjects should be given a medical questionnaire prior to testing to check for contra indications All subjects should be given a set of
72. quirements 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 Annexe B for installing the Diagnostic Instruments Manager Software As well as controlling the Multi Channel Plethysmograph 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 2 Connecting the Plethysmograph Connect the Computer Interface Cable between one of the sockets marked Equipment Interface on the USB 2527 Computer Interface and one of sockets marked Computer Interface on the rear panel of the Plethysmograph Connect the USB 2527 Computer Interface to a USB2 0 or higher port on your computer via the supplied USB isolator see Figure 1 using the two supplied USB cables To ensure patient safety the USB 2527 Computer Interface should never be connected directly
73. r national requirements with respect to disposal Please contact your local authority dealer or supplier for further information Penalties may be applicable for incorrect 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 9 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 number PG 009 HVLab Multi Channel Plethysmograph Page 49 of 53 Issue 9 0 Instructions for Use 01 10 10 10 Troubleshooting guide Problem Possible Cause Solution No Power The AC power lead has become disconnected from the plethysmograph There is no mains power supply to the control box Check that the AC power lead is connected to the plethysmograph and that the power supply is connected to the mains The water level gradually drops during a test Leaking cuff Stop the test identify the leaking cuff and replace The air pressure gradually reduces during occlusion Leaking cuff Stop the test identify the leaking cuff and replace The flow suddenly drops Water or air tubes are kinked There is an air bubble in the system Check the tubing for kinks Wiggle the tubing to dislodge
74. r or the distribution box whilst not in use It is preferred that the connection between the Multi Channel Plethysmograph the distribution box and the PC is disturbed as little as possible as this may cause damage to the connections Care should be given to the handling of the Multi Channel Plethysmograph at all times 7 3 2 Accessories Strain gauges are very fragile Ensure not to over stretch or pull at the fragile silastic loop or the link between the silastic loop and the cable during use If the strain gauge is indenting the finger it will be overstretched and could damage the gauge and will restrict the blood supply Strain gauges should be stored in a fridge after use The pressure cuffs should not be over inflated as this will cause them to burst Prior to testing check the gauge is not too loose for the finger Never inflate the cuffs when they are not surrounding a finger cylindrical object of appropriate finger width After use pressure cuffs should be disconnected from the Multi Channel Plethysmograph and emptied of water 7 4 Disposal of accessories Strain gauges contain mercury which is a hazardous substance Dispose according to local environmental health guidelines Document number PG 009 HVLab Multi Channel Plethysmograph Page 45 of 53 Issue 9 0 Instructions for Use 01 10 10 In the event of a spillage remove the strain gauge from the finger and place broken component into a sealable plastic bag and sweep the spilled m
75. r patient select Finger Systolic Blood Pressure in the Test list box Click on Start New Test to open the Finger Systolic Blood Pressure Test window as shown in Figure 6 To retrieve the results of existing tests on the current subject select Finger Systolic Blood Pressure and click on View Test Results 4 2 Finger Systolic Blood Pressure Test Window 4 2 1 Subject Details The Subject Details section of the Finger Systolic Blood Pressure Test Window Figure 6 shows the details of the current subject which cannot be edited here The new test record that will be created in the finger systolic blood pressure test results database will be linked to this subject record 4 2 2 Test Parameters The Test Parameters section shows parameters of the finger systolic blood pressure test measurements that will be performed in the current test Combinations of parameter settings should be saved as a parameter set These parameters may be altered from the default values by selecting different parameter sets using the Parameter Set list box Additional parameter sets may be entered into the database and saved so they can be used again Existing parameter sets may be altered or deleted by clicking the Add New or the Edit Delete controls see Editing and creating new test parameters below The Test Parameters section includes the following values Document number PG 009 HVLab Multi Channel Plethysmograph Page 18 of 53 Issue 9 0 Instructions for Use 01 10 10
76. s tage tage ange esistance se aces ie OR 200 Amplifier YI Amplifier Y2 Ohms Y Setto Target On SS Pressure Of MER ee xi 58 0 24 Maximum Pressure Test ER C On Maximum hardware limited pressure 275 7 mm Hg 63 0 31 irculation Off Time to depressurise system 1 2 sec Inflation and Dump Valve Test c Target pressure 220 0 mm Hg 0 30 i A OP time to pressurise to target pressure 5 8 sec Inflation Valve z Clo Pressure with Dump valve open and Inflation valve dosed 221 6 mm Hg Pressure with Dump valve closed and Inflation valve open 178 6 mm Ha 45 0 25 Enable Deflation C On Pressure drop when Inflation valve opened 43 0 mm Hg Valve off Pressure after 5 seconds with Dump valve and Inflation valve open 0 0 mm Hg ng 035 op Se First stage amplifier gain 100 0 Second stage amplifier gain 10 0 Strain gauge current 50 0m4 4 Dump alve Control Word Return Word 01010100 C Hex 00111110 Exit Binary Figure 28 Pressurisation Test Successful plethysmograph before performing this test to prevent damage to the cuffs The Plethysmograph Pressurisation Test can be accessed through the Calibration window by clicking on Calibration at the bottom of the FSBP Test window and then clicking on Pressurisation Test at the bottom right of the Calibration window At the end of the Pressurisation Test the software will inform the user that the test has been completed
77. shows the connections and Figure 2d The recommended recommended placement of cuffs for water placement of cuffs for water perfusion perfusion The hand and lower arm should be supported Document number PG 009 HVLab Multi Channel Plethysmograph Page 13 of 53 Issue 9 0 Instructions for Use 01 10 10 during the test Position the hand so that the cuffs are just over the edge of the support Ensure the tube is not kinked as this can prevent the cooling water from flowing freely The tubing can be arranged over and under the cuff Figure 2e c A Strain Gauge should now be fitted to each of the digits and the reference digit Select the appropriate size strain gauge for each Figure 2e The hand and lower finger that requires measurement Figure 2f shows arm should be supported during the recommended placement of gauges Although the the test picture shows a green gauge the tension of the gauge around the figure should be the same for all colour gauges Too tight a strain gauge will result in interference with the blood flow in the fingertip The strain gauge should be selected so it applies light external pressure around the finger Care should be taken when placing the strain gauge that the subject is not caused discomfort the strain gauge is not overstretched and movement artefacts are avoided Figure 2f The recommended placement of strain gauges The strain gauges should be placed around the distal phalanx of the digits
78. subject and the date of test Document number PG 009 HVLab Multi Channel Plethysmograph Page 22 of 53 Issue 9 0 Instructions for Use 01 10 10 H Lab Finger Systolic Blood Pressure Measurement Eile View Help Start Stop Cancel Save FSBP Measurement 1 Air measurement Simulation SUBJECT Andrew Other REFERENCE 11203568 DATE and TIME 12Jan 2006 14 22 57 thumb 1 TT Lt T mm index T ml middle Strain tH J 4 ring E little All 130 270 Cuff Pressure mm Hg 0 Inflation Pressure mm Hg 240 9 Cuff Temp C 22 Deflation Rate mm Hgs 12 5 Cooling Time s 5 Cursor O Figure 9 The Finger Systolic Blood Pressure Measurement Window are also displayed At the bottom of the screen are the Inflation Pressure mm Hg Cuff Temp C Deflation Rate mm Hg s and Cooling Time s of the current measurement The colour of the cursor is shown in the cursor indicator The measurement location and colour of traces are indicated on the right of the graph If there is a problem with a gauge it can be identified immediately The test can be interrupted at any time by clicking on Stop By then clicking on Cancel the user will be returned to the Finger Systolic Blood Pressure Test window and any data will be lost The percentage strain of the strain gauge is measured and displayed in real time as the cuff deflates Once the measurement is complete the sof
79. surements to be completed in one test 4 2 2 3 No of measurement sites The number of fingers where FSBP is measured 4 2 2 4 Inflation Pressure The inflation pressure of the cuffs during cooling 4 2 2 5 Deflation rate The rate at which the pressure in the cuffs will be released after cooling has ceased 4 2 2 6 Cooling period The duration of the cooling and pressurisation of the cuffs in a measurement Document number PG 009 Issue 9 0 01 10 10 HVLab Multi Channel Plethysmograph Instructions for Use Page 19 of 53 4 2 2 7 Editing and creating new test parameters To create a new Set of test parameters click on the Add New button to open the FSBP Test Parameters window Figure 7 This contains four sections Parameter Set General Settings Settings for Individual Measurements and Settings for Individual Measurement Sites To define a unique parameter set alter the values within the General Settings section see 4 2 2 1 to 4 2 2 6 for definitions of parameter settings The Settings for Individual Measurements box allows you to define the temperature for each of the measurements Specify the temperature for each measurement by selecting the measurement number then select the temperature required for that measurement Tick air measurement if an air temperature measurement is required 22 C To move to the next measurement click Set the temperature for each measurement The Settings for Individual Measure
80. t The Water In and Water Out sockets are connected to a loop of water cuffs during a finger systolic blood pressure test 3 2 2 Rear panel A green Power Connected light on the rear panel is illuminated when the Multi Channel Plethysmograph is connected to mains power Two re settable fuses protect the Multi Channel Plethysmograph from mains surges see section 7 1 of this manual The binding post labelled with the symbol is for the connection of the protective earth lead to the Multi Channel Plethysmograph The power socket enables the transformer to be plugged into the Multi Channel Plethysmograph The Computer Interface 1 and Computer Interface 2 sockets are for the Computer Interface Cable from the USB 2527 Computer Interface to the Multi Channel Plethysmograph The Computer Interface Cable can be connected to either socket There is labelled socket for the Footswitch to connect the footswitch to the Multi Channel Plethysmograph Document number PG 009 HVLab Multi Channel Plethysmograph Page 10 of 53 Issue 9 0 Instructions for Use 01 10 10 3 3 Setting up the Multi channel Plethysmograph 3 3 1 Controlling computer and software The Multi Channel Plethysmograph is controlled by the HVLab Diagnostic Instruments Manager software running on a suitable personal computer The computer should have the following minimum specification e Must comply with IEC 60950 1 2005 Information technology equipment Safety Part 1 General re
81. 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 2527 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 installat
82. th cable is connected at all times 6 5 Faults and Repairs If a fault is detected the user should contact the manufacturer or the manufacturer s agent for advice There are no parts that can be repaired by the user or user s technical personnel All repairs must to be performed by the manufacturer or an appointed agent Document number PG 009 HVLab Multi Channel Plethysmograph Page 41 of 53 Issue 9 0 Instructions for Use 01 10 10 7 Warnings and Precautions 7 41 Hardware 7 1 1 Ambient temperature for normal use Care should be given to avoid an inflow of hot air into the cooling fans of the Multi Channel Plethysmograph during operation as this will cause the cooling system to excessively strain For this reason the ambient room temperature for normal use should be between 15 C to 25 C during operation 7 1 2 Power On and Power Connected light The Power On and Power Connected light should be illuminated if the plethysmograph is switched on and connected to the mains 7 1 3 Plethysmograph turned off unexpectedly If the plethysmograph has been turned off unexpectedly or if there is a system power failure there will be an error message Figure 30 informing you that there is residual pressure in the cuffs which will prevent you from being able to remove the cuffs from the subject s fingers This residual pressure will have to be removed manually This can be done by first disconnecting the tubes to both the AIR and WATER cuffs
83. the HVLab Finger Systolic Blood pressure Measurement window which are saved in the Data File shown in the Test Details section The View buttons open the HVLab Finger Systolic Blood pressure Measurement Figure 13 window the position of the cursor can be edited see 4 4 2 of this manual The scaling of the FSBP 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 iw Finger Systolic Blood Pressure Export Dialogue x Export finger systolic blood pressure results to a text file m Blood pressure to be exported IV Export only the current measurement Export all measurements in this test Additional data to be exported Subject and test information Test parameters Strain vs Time s Figure 15 Export options window available from the File menu Document number PG 009 HVLab Multi Channel Plethysmograph Page 26 of 53 Issue 9 0 Instructions for Use 01 10 10 ot H LAB Diagnostic Instruments Finger Systolic Blood Pressure Test File Edit Yiew Tools Help x 5 pomm FE HVLab Finger Systolic Blood Pressure Test PERSONAL DETAILS Surname Other D ate of birth 13 10 1950 Forenames Andrew Reference number 11208568 TEST RESULTS Test
84. the database this may take up to 10 seconds to complete This window sult will close automatically when the data have been imported L Ifthis dialogue fails to close or if you wish to cancel the date transfer select Cancel Import frorn the File menu 45 3355 n oe ee ee eee Figure 12 Waiting for data transfer Document number PG 009 HVLab Multi Channel Plethysmograph Page 24 of 53 Issue 9 0 Instructions for Use 01 10 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 2 Repositioning the cursor To change the estimated blood pressure values for a measurement click once on the required cursor The key to the selected cursor is displayed in the cursor indicator at the bottom right of the window Click once on the point of the finger systolic blood pressure trace that the cursor should be positioned Click once off any trace to clear the cursor Do this for all channels necessary Click All before saving or exiting the window Further instructions are available in the View Cursor Help menu 4 5 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 Finger Systolic Blood Pressure from
85. to the Air socket on the front panel of the Plethysmograph You should now have created a loop of cuffs incorporating the T coupler with one longer piece of tube linking the loop to the Plethysmograph Connect the supplied bypass tube between the Water In and Water Out sockets Place the cuffs around the medial phalanges of the test fingers Ensure that the tube is not kinked as this can impede the pressurisation of the cuffs c Select the appropriate size strain gauge for each finger see section 3 5 1 for information on gauge selection The strain gauges should be placed around the distal phalanx of each measurement sites between the knuckle and the base of the nail Figure 2f A good position can be achieved by bending the white connecting lead so the gauge and start of the lead is perpendicular to the finger Make sure that the lead will not be Document number PG 009 HVLab Multi Channel Plethysmograph Page 15 of 53 Issue 9 0 Instructions for Use 01 10 10 moved by movement from the air cuff The strain gauges must not be overstretched or twisted around the finger as this will limit the lifespan of the gauges and produce an inaccurate response Figure 2g Once a strain gauge is correctly positioned hold it in place by attaching it to the dorsal side of the hand using micropore tape Use a strain gauge on each of the test sites and on the reference site Figure 2i Connect the strain gauge on the thumb to the first Transducer soc
86. tware automatically places a cursor at the appropriate point on the graph for each measurement location Arterial inflow is permitted when cuff pressure is equal to or less than systolic pressure Inflow is detected by an increase in volume indicated by the strain gauge signal The finger systolic blood pressure corresponds to that pressure at which a volume increase is detected by the strain gauge or HYLab Finger Systolic Blood Pressure Measurement F Eile View Help Start Stop Cancel Save FSBP Measurement 1 Air measurement Simulation ee SUBJECT Andrew Other REFERENCE 11203568 DATE and TIME 12Jan 2006 14 27 16 thumb Pressure 112 8 mm Hg Strain 27 3 index Pressure 54 6 mm Hg Strain 72 5 ii T Fil middle Strain ot Pressure 85 7 mmHg Strain 51 3 ring Pressure 84 8 mm Hg Strain 67 0 little Pressure 84 6 mm Hg Strain 12 3 all ji i 301 260 Cuff Pressure mm Hg 20 Inflation Pressure mm Hg 95 1 Cuff Temp C 22 Deflation Rate mm Hgs 12 5 Cooling Time s 5 Cursor oO Document n Issue 9 0 Instructions for Use 01 10 10 Figure 10 Results of finger systolic blood pressure measurement Save in I YWF testing gt El c aa VWF 56_h pgm Save as type PGM Files PGM 7 Cancel I Open as read only Z Figure 11 Dialogue for saving finger systolic b
87. unive dele cenaterandvarebancvudeduneuadetsnedadesundewduncnddnderunevaltuwbeliien 2 De System IMPOrnatie ns cee sccctssecece sete eles ceeccren cesta re a E a eanas are e cet rania aeaaeai 5 Z Pr od ct Specifi caio aar arara aaa raaraa r a Aaa A A aA A a aa a Aaaa araa bpa aaao anakaa 6 eb T OSE PATAMELOIS arar ne cater avis eins alee RA vate ven a ee 6 2 2 Power requirements 0 cccccccccseeeeeeeeeececencaeeeseeeeeeescnnaasusssaeeeeesseaaaaesaceeeeeesensaaenneess 6 2 3 Te ChICal SPOCHICATIONS enre a a E A ERA 7 2 4 Equipment Classification cccccccccccccccecceeeeeeeeceeeeeeeseeeeeeeceeeeeeeeeseseseeeeeseeseseeseeeneeenss 8 3 Installation and COMMISSIONING sssssssssssssnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nn 9 3T System Components syer a A A eis eaaa E anes AIENEA 9 EPE lT N E E E E 10 3 2 1 Frontpanel P EE A E 10 3 2 2 REAM DANMelt cascascancseock inae a e ea e O RE 10 3 3 Setting up the Multi channel PlethySMOQraph 2 cccscceceeeeeeeeeensteeeeeeeeeeeeeesnaaees 11 3 3 1 Controlling computer and software c ccceeeeeeeeeeeeeteeeeeeeeeeeeeeeeteeeeeeeeeeeeees 11 3 3 2 Connecting the Plethysmograph icc sesecied eee cee oti ti cneetecevn ad cer nee eneoweny erates 11 3 3 3 Avoiding interference between the Plethysmograph and other devices 12 3 4 Setting up the pressure cuffs and strain GAUGES eeeeeeee cece ee eeeeeeeeeeeeeeeeeeeeeeeeeeeeeeee 12 3 4 1 Arrangement of
88. vibration ccccccccececeeeeeeeeeeeeeeeaeeeeeeeeeeeeeeeaaeaeeeeeeeees 46 7 6 4 Previous exposure to extremes of temperature ccccceceeeeeeeeeeeeeeeeeeeeeees 46 7 6 5 Previous exposure to vaso active substances and alCOhol cccccseeeeeeees 46 7 6 6 ROOM temperature ceeecccee ccc ce ee eeeeeeeeeeeeeeaaeeaaeeeeeeeeeeaaaeaaeeeeeeeeeeeaaanseeeeeeees 46 FOA POSUlG stro a a ane Aiea a ie i ee 47 7 6 8 Size of strain gauges and pressure CUPPS ccceeeeeeeeeeeeeeeeneeeeeeeeeeeeeeeeaaees 47 7 69 gt POSIION OF Strain gauges ri soxcricesevesent somesideserdsad sevardiedevdsenl aa deei Raa 47 7 6 10 Instructions to SUDJOCIS 10 ccc0i secscedevecsevieyeveeedek ised Vateselsvnseviayeweeedseeeseebs eects 47 8 Spares and ancillary Services co ccececieccesssenetocetietcenetentescbeudceeeseessanenbeceventanctoreteteceueeted 48 D gt _DiSPOSall tieiiieciicdcdecc cess iesaied TET decd cosa svasiedidececesaivaasedstecscaceavassesisesciecosevanedsiedectses 49 9 1 Information on Disposal for Users of Waste Electrical amp Electronic Equipment excluding private households j c 0 ccnehstiicisesni dicen Giada 49 9 2 Information on disposal in other countries outside the European Union 49 10 TrOUDIESHOOTING guide sssri ankai a naana aa aaea aaae a aaea aeaa Eaa Eia 50 11 Explanation Of Crim wiscccieescccccesccccceuecccesccetsescouscsceasvacsvscecsicovesvsssestsseicecesusvedsinsesceses 51 12
89. without a subject for demonstration Document number PG 009 HVLab Multi Channel Plethysmograph Page 31 of 53 Issue 9 0 Instructions for Use 01 10 10 5 2 4 Test Results The controls in this section allow you to start and repeat finger blood flow runs The test results table shows the Run number and the average blood inflow at each measurement site Click on the Start button to launch a finger blood flow run Clicking on Start opens the Pressure and Temperature Control window which guides the user through the sequence of actions to prepare to perform a finger blood flow measurement N B If the data import window is seen please ignore Go to the Pressure and Temperature Control window Section 5 3 of this manual for instructions on running finger blood flow measurement When all the measurements have been completed click on the Save and Exit button 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 Test will return to the Control Panel window without saving the test results 5 2 5 Calibration Window The Calibration button opens the Calibration window This is a means for you to control the Multi Channel Plethysmograph during calibration and is not required for diagnostic testing Calibration should only be performed by a certified HVLab technician 5 3 The Pressure and Control Window The pressure and control window contains the

Instructions for Use HVLab Multi

Contents

Download Pdf Manuals

Related Search

Related Contents