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Users` Manual - Piston Medical

1. 0 0 P size P counter 0x13 Plow_DataL Plow_DataH Deh Dot Phigh DataH 0x13 Example 2 syringe pressure and syringe temperature channels are both active Data sent by device 0 0 P size P counter 0x13 Plow_DataL Plow_DataH Phigh DataL Phigh_DataH PEO MERA ERE RA SAA SO A O E AAA A A PA A A A AAA AAA A A PWG 33 Waveform Generator USB Protocol Specification 14 11 Examples of communication 11 1 Read device descriptors Read version theoretical PC sends Device response 1 0 P size P counter 0x00 0x01 Device type_ Minor ver Major ver Channel numb Channel numb Read version in case PWG 33 PC sends Device response Lol 001001 9 P counter ug Oxot 0x6 Oxor 0x01 0x13 0x18 0x19 PWG 33 Waveform Generator USB Protocol Specification 15 11 2 Read chanel descriptor channel 11 PC sends P counter OxOB Device response LO 3 Pcounter 0x0B_ 0x05 channel descriptor 60 byte 11 3 Write chanel descriptor channel 11 PC sends New channel descriptor 60 byte Device response LO 3 Pcounter 0x0B_ 0x06 Me channel descriptor 60 byte PWG 33 Waveform Generator USB Protocol Specification 16 PWG 33 protocol specification 11 4 Sample start PC sends l P counter Sampling starts Device response o 3 P counter Gut 0x02 S 11 5 Sample stop ro C sends
2. User Manual Pulmonary Waveform Generator 42 Quick test 6 4 8 Back pressure graph Click the button Show back pressure graph to shows the back pressure diagram of the last generated waveform including the waveform and the estimated shape of the airflow on the pneumatic outlet Take into consideration that the backpressure represents the total internal pressure of the syringe Obviously the effective backpressure of the device being tested 1s only a part of this value Estimated shape of the airflow on the pneumatic outlet is calculated from the measured back pressure and the volume remained in the syringe Entering proper ambient pressure 1s also required for the calculation Back pressure graph is refreshed automatically after each test 2 Test Result Graph aag El Test profile RB Back pressure _ Output signal Measured data Content of the graph e Shape of selected waveform green e Measured back pressure red e Estimated output signal yellow e Measured data reported by the device being tested in interface mode 6 5 Reports After finishing tests e Store results e Print reports Quick tests also can be suspended See chapter 5 8 Reports for details User Manual Pulmonary Waveform Generator 43 Resistance test 7 Resistance test 7 1 About the test 7 1 1 Purpose Main goal of resistance testing is to precisely determine an object s resistance to flow in an automatic way While ATS recom
3. Configure Open configuration window Close Close PWG software 5 3 Configuration Click the button Configure on the Welcome Screen to open configuration window 5 3 1 Set institute data Institute data will be printed on reports and stored in project files To change this data perform the following steps Choose the tab Institute Data Fill the form implicitly User Manual Pulmonary Waveform Generator 24 Software overview 5 3 2 Custom logo Custom logo will appear on screen and will be printed on reports To use custom logo Create a logo image of 620x320 pixels in size Store it in standard 24 bit bitmap format Copy the logo to PWG software s installation folder replace existing logo 5 3 3 Configuration of the Waveform Generator To change device related parameters Choose the tab Device setup Return to zero speed Speed of the piston in l s moving to zero position This setting is stored in the device exh Institute data BEE di Device setup itself option is only available if the device is Ry Resistance test setup connected Default value is 5 l s Baum t zarg apsal BTPS inspiration speed Ys BTPS inspiration speed ita Speed of the piston in l s during inhalation ron deet mode atter of heated and vaporized air Default value 1s 0 5 l s Adjust this option carefully as too high values can lead to step error or direct water inhalation Store piston temperature log Piston
4. According to former described physical reasons BTPS simulation is not available when generating Spirograms 8 5 2 Normal and Inverse mode Normal and inverse mode are both usable and acting the same way as described for simple waveforms 8 5 3 Generating Spirograms Opening or create the desired Spirogram Before generating Spirograms Verify if there is no break in the volume curve Use binding blocks to fix them Select curves for inspiration and expiration maneuvers if they are containing waveform sets Start or repeat test To start Spirogram click the button Start Spirogram The Spirogram will be downloaded to the device Spirogram generation will start automatically To repeat the last Spirogram without downloading it again click the button Repeat Spirogram Spirogram generation can be aborted any time by clicking the button STOP 8 5 4 Recording test results PWG software can record five series of test results for each Spirogram After each test the software pops the same results table as for simple waveforms to enter measured parameter values Switch between parameters by pressing Enter on the keyboard to speed up data input Pressing Enter at the last parameter will close the window and record the entered parameters in the test report User Manual Pulmonary Waveform Generator 52 Complete Spirograms 8 6 Examples 8 6 1 Calibration signal sine two speeds Create two sine waveforms having PEF
5. 10 1 1 Replacing fuses Fuse box is built into the line power connector housing located on the back panel of the equipment e Use a screwdriver to open the fuse box WARNING Replacing fuses with wrong type and value can result in serious damage to the equipment Recommended fuses Line power Fuse 115 VAC 250V 10 A T 230 VAC 250V 6 3 A T 10 1 2 Periodic lubrication After 100 000 cycles lubrication is recommended That means testing approximately 1000 spirometers according to standards ISO 26782 and ISO 23747 or 2000 peak flow meters according to ISO 23747 standard Piston and cylinder Use lubricant only specified by the manufacturer e Interflon Ltd Fin Food Lube Teflon e Suggested quantity Spray one 1 second Procedure Move the piston to PISTON IN position the farthest position from the pneumatic outlet Apply the lubricant through the pneumatic outlet to the inner surface of the cylinder Generate a few 10 liter square waves to smooth the grease Repeat the two previous steps a few times Use the drain valve located at the left lower corner of the equipment to remove surplus lubricants from the cylinder User Manual Pulmonary Waveform Generator 57 Maintenance BTPS valve Check the BTPS valve according to section 10 4 1 Adjusting BTPS valve If necessary adjust it Use lubricant only specified by the manufacturer e Interflon Ltd Fin Food Lube Teflo
6. 29 Software overview 5 5 6 Testing multiple devices When testing multiple devices it is recommended to perform ATP test BTPS turned off first on all devices Perform the ATP tests in a row on each device Store a report file for each device Turn on BTPS simulation For each device in a row Perform the BTPS tests Update the report file by storing it again Print the test report 9 6 Restrictions BTPS simulation mode can be used for any waveforms with trivial physical restrictions e Full BTPS simulation is only available in Quick test mode Complete Spirograms can only be generated with heated air Explanation of this is that the BTPS inhalation can not be performed through the flowmeter being tested and so the maneuver would break the Spirogram e BTPS simulation is obviously not available in inverse mode e BTPS simulation is obviously not available if tidal breathing cycles are preceding the main waveform of the test for the same reason as completes Spirograms can not be generated 5 7 Device under test Parameters of the device under test must be shown in the test report To enter required data select the Tested Device tab in the measure screens laS PWG Manage Waveforms wl pi luonus djeres Ier 0 Trion 277 CH Tama 25 Pama 1018 hPa Bien 80 yole OF du Waveforms Pros Flow Resistance _ Sets 1 Te ed Device Tested device Manufacturer Device type Serial number Sample Ltd Spo 3 Ac
7. s temperature is logged when the PWG application 1s started This log can be stored for later analysis Default value is No Enter sleep mode after When the PWG application is started the device is set to Sleep Mode after the idle time that was set here 5 3 4 Configuration of flow resistance test To set up flow resistance test S elh Institute data PA Acceptance criteria E GE Gen Choose the tab Resistance test Pa i EE SE setup Nee S Test order R S a w Minimal flow 5 000 Ys Resistance test starts with an initial flow rate _ Ags that is increased in each cycle with a constant maximainow ma We flow rate until a maximal flow rate is Passes Jrs AA achieved but not exceeded Lo Step count Passes Each flow rate will be repeated the given times Units Entered flow values and the test report will use the selected units liters sec or liters min Step count Shows number of iterations between initial flow and maximal flow rate User Manual Pulmonary Waveform Generator 25 Software overview Test order Defines how passes should follow each other run the first flow rate test the given of times before doing the next flow rate step or do the whole test the given of times 5 3 5 Acceptance criteria To set up custom acceptance criteria Choose the tab Acceptance criteria Accuracy of waveform generator The accuracy of waveform generator according to referred standards
8. I s7 SR O EE 3000 1 7 GEET 0 34 0 36 ml el 10 10 5 I Available e ra 10 11 l Default values may wary on individual device instances 12 4 PWG syringe temperature Ch25 Channel configuration CUSO dida 8 A EN 25 SIMPLE UM a 1000 ACNE iaa sas es l Other parameters Not used free for any user data PWG 33 Waveform Generator USB Protocol Specification 19
9. PWG 33 Software Interface Developer s Guide Copyright 2012 All rights reserved Created 20 04 2012 Version v1 00 Modified 20 04 2012 User Manual Pulmonary Waveform Generator 69 Contents GON E A a E el are 2 1 About PWG Software Interface 2 2 Ne OUI S Sinn oil 2 9 BCT descripciones 2 4 Configuration Of Interface Principe OT elei et rra Sala ee EE ore Measure Men CONIO usaron oca implementation GUldE arrari on erate eee 4 1 Define constants and vaables 4 2 Prepare the interface AA 4 3 Initializing interface pwg _WM_INITINTERFACE aaannnnannnnannnnna 4 4 Initializing measurement pwg_WM_INITIALIZE 4 5 Starting measurement owg WM _STARTMEASURE 4 6 Stoping measurement owg_ WM _STOPMEASURE 4 7 Reporting results pwg_WM_RESULTAVAILABLE 4 8 Closing interface owg WM DIGCONNECTII SING the Nena C E 2 Introduction 2 1 About PWG Software Interface PWG Software Interface is a communication interface between main PWG application and spirometer software designed to be used during product development and validation 2 2 Main purpose PWG Software Interface makes it possible to do validation test of Spirometers automatically without any user interaction Measurement control and reporting results are controlled by the interface Key design consideration was to give an easy to understand eas
10. l Sampling stops Device response oj 3 P counter 0x02 0x02 S 11 6 Send PGW status Device send UO 0x3F P counter Ox0AOA 11 7 Not supported command go C sends l SUPPORTED S Device response o 3 P counter mt 0xFF __ S PWG 33 Waveform Generator USB Protocol Specification 17 PWG 33 protocol specification 12 Default values 12 1 Extra Descriptors Ch00 Channel configuration ON Sie erie aie OI 0 COTTON Der sateen deat suena oe eee ote eset eee 0 Sample IM is 0 EE ee 0 Other parameters KE EE Waveform Generator SS RE UMNO fe sec arcana iret ES EIA PWG33 20XX xxx e where 20XX is the year of production didas and xxx 1s a 3 digit counter 12 2 Syringe pressure descriptor Ch19 Channel configuration A is o e pe eros o eee te aad 4 Be NR reeL EE 19 EEN 4 ACNE iii Geet l Pressure Sensor IOW Pal A Saa 4000 4200 Pressure sensor low RA Dead 3500 4500 Pressure Sensor high Eege ege ee 4000 4200 Pressure sensor neh El E 100 200 12 3 PWG status descriptor Ch24 Channel configuration A O 8 A EE 24 SAPE eeneg 1000 EE l PWG 33 Waveform Generator USB Protocol Specification 18 PWG 33 protocol specification Other parameters Max flow of BTPS mhalanon 0 5 l s Calibraton stops traida 10000 12000 step Main clock freguenc y aii 30000000 Hz MAMI LOW ita isa 20 0 l s Minimum delay daban 500 clock eelere ee 3000
11. musical note 200 Hz G musical note Plunk the lower part of the belt to generate sound You can use a universal belt tension meter or a simple PC microphone and chromatic FFT tuner software to measure the frequency If the frequency is too low then you should readjust the tension User Manual Pulmonary Waveform Generator 60 Maintenance 10 3 2 Adjusting tension Loosen the 4 screws fixing the rear bearing block with 4mm hex key Loosen the safety nut with 10 mm wrench Use the 10 mm wrench to adjust belt tension by tightening or loosening the screw Ka ys De 3 y After finishing the adjustment fasten the safety nut and the 4 screws and check the frequency again 10 3 3 Replacement Timing belt should be replaced if it is worn or it is over stretched Use timing belt only specified by the manufacturer e Optibelt Alpha T2 5 950 12 Procedure Release the timing belt as shown in the previous section Move the piston by hand until the fastening plate coincides with the mounting hole Unscrew the 2 slotted head screws from the timing belt fastening plate Replace the timing belt to a new one and fix it Adjust pre tension of the new timing belt User Manual Pulmonary Waveform Generator 61 Maintenance 10 4 Sealing 10 4 1 Adjusting BTPS valve The abrasion of the PTFE rings should be checked after every 10 000 cycles of the BTPS valve The slider plate should be in midd
12. 12 BTPS D I parameter F Waveform Library Waveform control 6 2 Managing waveforms Waveforms can technically be separated into two main groups e Periodic signals sine square User defined sine waveforms User defined square waveforms e Predefined waveforms 13 Standard waveforms ISO 26782 10 Standard waveforms ISO 23747 While flow values of periodic signals are calculated on fly according to some parameters entered by the user predefined waveforms are described by a series of volume or flow data points in function of time ATS Standard volume time waveforms 26 ATS Standard flow time waveforms User Manual Pulmonary Waveform Generator 34 Quick test 6 2 1 Selecting waveforms Waveform toolbar Use waveform toolbar to quick access main waveform groups Waveform library Click the arrow button gt at the left edge of the screen to show waveform library Waveform library grants direct access to predefined waveforms in Library section and user defined waveforms under the Custom section Selected waveform Selected waveform field shows the group and the name of the selected waveform for example LSO2ZS 747 OA eat Use the arrow buttons Tal and P to select next waveform in the current group Waveform display Waveform display shows flow volume volume time and flow time graphs of the selected waveform Track bars around this display are allowing the user to transform wavefor
13. 1945 1939 1944 1943 1294 3 4 CCess resistance 17 00 1 s 785 783 784 784 2301 2300 2300 2300 1516 t t 18 50 l s 928 929 936 931 2689 2696 2690 2692 1761 y es 20 00 1 s 1086 1083 1079 1083 3094 3094 3093 3094 2011 Inspiration 2 00 1 s 21 21 21 21 105 105 105 105 SA 41 88 3 50 l s 62 62 62 62 237 238 238 238 175 50 06 gt 5 00 l s 123 122 122 122 408 413 409 410 288 57 58 6 50 1 s 199 199 200 199 621 621 621 621 421 64 83 8 00 l s 293 292 293 293 873 874 873 873 581 72 58 9 50 1 s 402 401 404 402 1193 1193 1193 1193 791 83 22 11 00 1 s 529 527 531 529 1545 1544 1544 1544 1015 92 32 12 50 l s 674 672 673 673 1928 1934 1931 1931 1258 100 61 a 14 00 1 s 827 828 829 828 2376 2377 2313 2376 1547 110 54 Resistance 15 50 l s 1022 1019 1026 1022 2827 2839 2842 2836 1814 117 04 17 00 1 s 1231 1230 1235 1232 3343 3362 3366 3357 2125 124 98 H 18 50 1 s 1461 1442 1455 1453 3913 3917 3908 3913 2460 132 97 d lag ram 0 00 1 s 1680 1675 1676 1677 4506 4506 4508 4507 2830 141 49 Resistance 18023747 Test Report For normal resistance test Test report includes e PWG calibration data for in and expiration e Cumulative resistance of PWG and tested device for in and expiration e Effective resistance of the object being tested for in and expiration During calibration of ISO Test profiles Test report field shows the measured resistance of PWG without any objects connected User Manual Pulmonary Waveform Generator 45 Resistance test Resista
14. ATS26 01 ATS26 02 ATS26 03 ATS26 04 ATS26 05 ATS26 06 ATS26 07 ATS26 08 ATS26 09 ATS26 10 ATS26 11 ATS26 12 ATS26 13 ATS26 14 ATS26 15 ATS26 16 ATS26 17 ATS26 18 ATS26 19 ATS26 20 ATS26 21 ATS26 22 ATS26 23 ATS26 24 ATS26 25 ATS26 26 ATS24 01 ATS24 02 ATS24 03 ATS24 04 ATS24 05 ATS24 06 ATS24 07 ATS24 08 ATS24 09 ATS24 10 ATS24 11 ATS24 12 ATS24 13 ATS24 14 ATS24 15 ATS24 16 ATS24 17 ATS24 18 ATS24 19 ATS24 20 ATS24 21 ATS24 22 ATS24 23 ATS24 24 ATS2601 ATS26 02 ATS26 03 ATS26 04 ATS26 05 ATS26 06 ATS26107 ATS26 08 ATS26 09 ATS26 10 ATS26 11 ATS26 12 ATS26 13 ATS26 14 ATS26 15 ATS26 16 ATS26 17 ATS26 18 ATS26 19 ATS26 20 ATS26 21 ATS26 22 ATS26 23 ATS26 24 ATS26 25 ATS26 26 15026732 01 1502678202 15026782 03 1502678204 15026732 05 ISO026782 06 1802678207 15026782 08 1502678209 ISO26782 10 1IS026782 11 1502678212 ISO26782 13 ATS24 06 ATS24 1 150 Sine Tizliter Square Teszt Forditott SquareTeszt Sine Hatliter Sine Negyliter Sine Kettoliter ATCIAMA o Delete set Add new set Store set Waveform trash Set list Shows list of the available waveform sets Click an item to view or edit details Set details Shows details of the selected waveform set You also can edit the set see next chapter for more information 6 3 1 Add new set Click the button New set to add a new set Unlimited number of waveform sets can be added Name of set Enter a name fo
15. Absolute and percentage range of measured values e Absolute and percentage deviation of measured values 5 8 2 Reporting function SS A AA J e AAA AAA AAA j Load Report H Store Report New Test Store test Load test Print test report New test Click the button New Test to create a completely new test This will clear data of device being tested results of resistance test and waveform tests Storing test results Click the button Store Report to store all test results All results will be stored into a single results file Configuration used for resistance test 1s also stored Waveform files are not stored Loading test results Load results from a report file for all tests Configuration of resistance test will also be loaded Starting resistance test after loading a report file will perform the same test structure as defined in the report file To perform a test according to the procedure described in the current configuration of the PWG software click the button New test on the Resistance test tab first If the report file refers to waveforms or waveform sets that are not present an error message will appear Wave rocnu cisco 7 iene ace toumeo da ns Jeer User Manual Pulmonary Waveform Generator 32 Software overview 5 8 3 Suspending or postponing test All tests performed can be interrupted suspended or postponed ee Le L Le Store test results Do other tests or even
16. B Aun el F 1 Groh New test Enable tidal Start Repeat Show back cycles waveform waveform pressure graph New test Clear current waveform test results Enable tidal cycles Turn on or off leading tidal breathing cycles preceding the main waveform of the test Start waveform Download selected waveform to the device and start waveform generation Repeat waveform Repeat the last downloaded waveform Show back pressure graph Shows a back pressure diagram for the last generated waveform including the waveform and the estimated shape of the actual airflow at the pneumatic outlet User Manual Pulmonary Waveform Generator 39 Quick test 6 4 1 Starting a new test To start a completely new test select the Tested Device tab in the measure screens and click the New Test button To clear Resistance test results only select the Tested Device tab in the Quick Test measure screen and click the New Test button To clear waveform test results only select the Waveform tab in the Quick Test measure screen and click the New Test button 6 4 2 Scaling waveforms Any predefined volume time and flow time waveforms can be scaled on both flow and volume axis of an FVC Spirogram Use track bars around waveform displays to scale waveforms flow rate or volume The three track bars are in fact only two flow and time will be moved parallel while volume track bar changes volume data point values beside a constant inpu
17. Click Finish to close setup application Open the Start menu to launch the installed application 2 4 Post install configuration Launch the installed application You will arrive at the welcome screen The PWG Software automatically recognizes if the device is connected or not Drive letter assigned to the built in SD card is also detected If the device is connected a confirmation text will appear at the top of the window DEWLee conmecues as DRIVE where DRIVE is the actual drive letter assigned to the SD card 2 4 1 Check device connection To test device connection and check its basic mechanical and electrical parameters click the button Device Info The following information will be displayed User Manual Pulmonary Waveform Generator 14 Installation Type of generator PWG 33 or PWG 33BT Serial number Serial number of device PWG 33 BT 20yy nnn where yy is the year of construction nnn isthe serial number of device Functional volume of the generator Volume of the syringe including dead space Step count between the two calibration photo interrupters 2 4 2 Set institute data Institute data will be printed on reports and stored in project files To change this data perform the following steps Click the button Configure the Setup dialog box will pop up Choose the tab Institute Data Fill the form implicitly To store settings click OK 2 4 3 Configuration of the Waveform Generator S
18. Enter BTPS data Temperature Pressure Humidity 5 4 3 BTPS toolbar Abut using BTPS simulation mode read the relevant chapter 5 5 BTPS simulation BTPS toolbar groups two controls BTPS mode switch Desired temperature BTPS mode switch Click BTPS switch to enable or disable BTPS mode dy Blue icon BTPS mode disabled g s Red icon BTPS mode enabled heating l Green icon BTPS mode enabled Desired temperature reached Desired temperature Use spin buttons to set desired temperature User Manual Pulmonary Waveform Generator 28 Software overview 5 5 BTPS simulation ATS and ISO standards prescribe to test spirometers by discharging gas at BTPS conditions 5 5 1 BTPS simulation in general Heated air can be provided any time by turning on BTPS simulation even without connecting the humidifier Any waveforms can be generated using full BTPS simulation mode but BTPS conditions can only be guaranteed if the waveform contains only expiration maneuvers With BTPS simulation turned on PWG will automatically move the piston to its end position and inhale the required amount of heated and vaporized air to discharge the selected waveform 5 5 2 BTPS maneuver If BTPS simulation is turned off the process of waveform generation goes as follows e The piston is starting from its zero position e The requested waveform is generated If BTPS simulation is turned on the process of waveform generation goes
19. Generator 18 Device overview Control cycle e When the piston is in zero position control button will start generating the default waveform if present During waveform generation control button will stop the piston at current position When the piston is not in zero position control button will move it to zero position Control button interrupts even the go to zero operation and will stop the piston at the current position Control button can only be used in NORMAL mode The user is responsible to use a non inverse waveform 3 2 4 Remote control port optional Remote control port was designed to control the PWG from an external electrical device The DIN 45322 5 pin at 60 plug has two control ports on two different pair of wires Pin Technology Voltage range Polarity Optocoupler 3 25VDC Reed relay 4 7VDC Schematics are showing the female DIN plug on the front panel and external view Principle of device control corresponds with the mechanism described for control button 3 2 5 Calibration port These two BNC connectors can be used for kinematics checking See chapter 4 2 Kinematics checking for details 3 3 Error messages Heating indicator e Heating indicator blinking briskly after setting Ambient valve refers to valve error Pump end position indicators e One indicator lighting another blinking refers that the piston ran out of range at the end signed by the blinking indicator
20. The device 1s always sending a reply to each command This response begins with the same 4 bytes like the command only the 6th bit of the 1st byte 1s turned to zero Lol P size P counter Command PWG 33 Waveform Generator USB Protocol Specification 3 5 Supported commands 5 1 Common commands Command name Code Data after the Response after Comment command bytes command bytes Read version 0x0100 Ist byte Device Packet size 6 is Type equal to the PWG 33 is 0x0F number of channels 2nd byte Minor ver amp amp OxX3F 3rd byte Mayor ver Ath byte list of available channels Read channel OxO5nn channel descriptor nn identification descriptor 60 byte number of the channel Write channel Ox06nn new channel modified channel nn identification descriptor descriptor 60 descriptor 60 byte number of the byte channel Not supported Response is commands OxFFFF 5 2 Device specific commands Command name Code Data after the Response after Comment command bytes command bytes Re A PWG Set BTPS OXx0AO01 1 byte Valve 0 AMBIENT 1 BTPS PWG Set Syringe 0x0A02 2 byte Turn syringe and Temperature Temperature x 100 humidifier heating on Humidifier s temperature is automatically set 1 C higher Value of Ox FFFF will switch the heating control off PWG Set BTPS 0x0A03 2 byte Sets the Temperature Temperature x 100 humidifier s temperature only Humidifiers temp
21. as follows e Dry air is first discharged e PWG is inhaling the sufficient amount of vaporized air until the remaining volume in the cylinder equals to the volume of the curve to be generated e The requested waveform is generated 5 5 3 ATS According to ATS publication Appendix B Paragraph 8 Page 1128 diagnostic devices should be also tested by injecting at least four waveforms using heated and humidified air The first four standard waveforms should be generated in three trials The time interval between trials should be less than 2 minutes The temperature of the air injected should be 37 C 1 C 5 5 4 ISO 23747 According to ISO 23747 standard Annex B Paragraph B 3 6 Page 10 diagnostic devices should be also tested by injecting heated and humidified air All the standard waveforms should be generated in five trials using gas at a temperature of 34 C 2 C and a relative humidity above 90 with air conditions at BTPS The time interval between trials should be less than 2 minutes 5 5 5 ISO 26782 According to ISO 26782 standard Annex B Part B 3 Paragraph e Page 17 diagnostic devices should be also tested by discharging defined test profiles C12 and C13 with gas at a temperature of 34 C 2 C and a relative humidity above 90 to the spirometer including its accessories and detachable parts The time interval between trials should be less than 2 minutes User Manual Pulmonary Waveform Generator
22. different folder click Browse Pulmonary waveform Generator Browse IS Sear P E Back Jl Next gt Cancel r A Setup Pulmonary Waveform Generator PWG 33 a cs e Select Additional Tasks Which addtional tasks should be performed Select the additional tasks you would We Sebup to perform while installing Pulmonary Waveform Generator PYIG 33 then dick Next Adational cons Create a desktop icon lt Back Next gt JL cancel 2 Setup Pulmonary Waveform Generator PWG 33 Ready to Install D Setup is now ready to begin nstaling Pulmonary Waveform Generator PWG 33 A on your computer Q Cick Install to continue with the installation or click Back if you wank to review or change any settings Destination location C Program Fies Pulmonary Waveform Generator Start Menu folder Pulmonsry Waveform Generator Additional tasks Additional icons Create a desktop icon lt Back Install al Cancel Completing the Pulmonary Waveform Generator PWG 33 Setup Wizard Setup has Finished installing Pulmonary Waveform Generator PWG 33 on your computer The application may be launched by selecting the instabed icons Click Finish to exit Setup Installation If required select a different Start menu program group Or click Next to skip this step Uncheck the checkbox if you do not want to create a desktop icon Or click Next to skip this step Click Install to start copying files
23. e Both indicators blinking are referring to step error User Manual Pulmonary Waveform Generator 19 Device overview 3 4 Firmware update Firmware is the internal software of the PWG s built in microcontroller Do not mix it up with the software running on the PC Updating the firmware is necessary only when your supplier calls your attention for that WARNING A Improper implementation of firmware update can permanently lose device functionality Always keep instructions of this documentation Firmware update of PWG 33 is possible via standard USB connection Firmware update tools are bundled with the firmware binary file Firmware update tool PIC32UBL exe 3 4 1 Checklist Before you continue read the following remarks carefully e Never try to update the firmware if not necessary e Always consult the manufacturer before doing a firmware update e Check the documentation of the firmware release about compatibility e Always use an uninterruptable power supply to avoid power loss of device and PC during the operation 3 4 2 Step by step Perform the follow the instructions Plug the PC to an uninterruptable power supply or use a notebook with fully charged batteries Copy the firmware update tools and the binary file holding the new firmware to the PC Use the PWG configuration tool to store device parameters see firmware release notes Turn off the device Connect the device to an uninterruptabl
24. generate sine and square trapezoidal waveforms configured by the user Variable parameters are peak flow expired volume period time and rise times This periodic waveforms then can be repeated a given number or even infinite times Defined sine and square waveforms can be stored in the Waveform Library 5 1 3 Generating predefined waveforms PWG 33 provides four main groups of predefined waveforms e 24 ATS Standard volume time waveforms e 26 ATS Standard flow time waveforms e 13 Standard waveforms according to EN ISO 26782 2009 Annex C e 10 Standard waveforms according to EN ISO 23747 2009 Annex C profile A and profile B User can define further custom waveforms and waveform groups Any waveforms can be completed by leading tidal cycles and can be generated with BTPS simulation 5 1 4 Scalable waveforms Any predefined volume time and flow time waveforms can be scaled on both flow and volume axis of an FVC Spirogram This feature can unveil a cheat based on shape recognition of ATS curves observed in connection with some poor quality spirometers 5 1 5 Automatic measurement of flow resistance PWG software is measuring flow resistance of tested objects in full automatic mode User has only to configure the tested flow range Determination of the internal resistance of the PWG is also being performed automatically 5 1 6 Composing complete Spirograms PWG 33 s capabilities allow to move more than 150 000 liter of air in a s
25. section 10 5 Troubleshooting guide User Manual Pulmonary Waveform Generator 58 Maintenance 10 2 Disassembling WARNING Before opening the device please make sure it is disconnected from line power 10 2 1 Tools List of tools needed for disassembling e Hex key 5 mm min 200 mm long with spherical head and T handles e Hex key 4 mm min 100 mm long with spherical head and T handles e Hex key 3 mm min 100 mm long with spherical head and T handles e Hex key 2 5 mm min 100 mm long with spherical head and T handles e Open end wrench 10 mm 2 pcs e Socket wrench 13 mm e Slotted screwdriver min 100 mm long 4 mm blade with 10 2 2 Removing the cover Unscrew the 4 screws with 4mm hex key You can pull up the cover by grabbing on the edge of the upper aluminum profile with both hands User Manual Pulmonary Waveform Generator 59 Maintenance 10 2 3 Removing the main front panel Use 10 mm wrench to loosen the nuts on both side Take care of the cables and connectors Carefully fold down the main front panel taking care of the cables connected to it 10 3 Timing belt 10 3 1 Check tension Tension of the timing belt should be checked after every 100 000 cycles or after a long term storage or transport Proper belt tension can be estimated by plunking the belt and measuring its frequency The required frequency range for the specified belt is e 160 Hz D
26. sequence of the generated waveforms It is easy to recognize this phenomenon because the measured flow rates and volumes will be unexpectedly high According to our experience this side effect may occur to the turbine type and to the differentiating flow meters like Pitot tubes Jn this case some pneumatic filter has to be installed in between the device being tested and the pneumatic outlet of the generator A good choice could be a laminar flow element like a Fleisch tube or a simple PFT bacterial and viral filter Be moderated in increasing the dead space and the resistance of the system apply serial pneumatic filtration only up to the necessary extent User Manual Pulmonary Waveform Generator 7 Introduction 1 6 Technical data 1 6 1 Pneumatic information Pneumatic outlet ISO 30 Medical taper Male OD 30 2 mm Basic taper 1 20 Maximal back pressure of the object being teste 4 0 kPa at 12 I s BYE ONT deat Res 9 101 8 00 8 RO 0 345 ml NEIE 10 00 E TOW Tania 20 0 l s Minimal rise time to flow ratel6 l s at back pressure 3 kPa ssnonsossssseeeessssssseserrrssssssese 4 ms Maximal slew rate to flow rate16 l s at back pressure 3 kPa ccccoonnnonnnccnnnnonos 4000 Us 1 6 2 Accuracy VOM iii 0 2 or 10 ml which ever 1s larger FION erect beasts O RT O 0 3 or 15 ml s which ever 1s larger T 0 02 or 1 ms which ever is larger Temperature of air with BTPS simulation eeeeeneess
27. that the device is ready to generate a waveform e Blinking status indicator refers that the device is in sleep mode Blinking frequency is 50 min e Status indicator blinking briskly after turning on PWG refers that the device is ready for firmware update Heating indicator e Turned off heating indicator refers that the BTPS simulation is turned off e Blinking heating indicator refers that BTPS simulation is turned on and the device is in warming up state e Lighting heating indicator refers that the device is ready for BTPS simulation Pump end position indicators The two LED s of Pump end position indicators can light up together or separate e Turned off indicators are referring that the piston is not in any of its end positions e Lighting only one of the two indicators refers that the piston is in the signed end position e One indicator lighting another blinking refers that the piston ran out of range at the end signed by the blinking indicator e Both indicators blinking are referring to step error 3 2 3 Control button Use Control button to manually send the piston to zero position start waveform generation or stop any movement Pressing the Control button will raise the following events Piston is in END position Generating default waveform Go to zero position Stop at current position Result of operation Impact of control button User Manual Pulmonary Waveform
28. the button All to batch process all waveforms in the group or set PWG 33 Software Interface Developer s Guide 9 Appendix 11 4 USB Protocol specification PWG 33 Waveform Generator USB Protocol Specification Developer s Guide Copyright 2012 All rights reserved Created 01 02 2009 Version v2 00 Modified 23 04 2012 User Manual Pulmonary Waveform Generator 70 1 Contents 1 EE 2 2 Brier OIC EE 3 3 OMAN Call O AAA ene bancuot enone pete sane ouauoeenotewibeseteeeeeoe 3 4 EIERE 3 Ds Supported Ee ein Et e EE 4 Dally COMMON COMMAS uo UE 4 5 2 Device specific commande 4 6 PANAMA channe Si e eee 6 7 Structure Of channel descrptore cccoccccccnccocnccccncccnnnnonnononnnononononononnnnnnnnnnnnnnss 7 Vale Extra Descriptors eeh ee 8 7 2 Syringe pressure descriptor Chi 8 Ta PWG Slatus descriptor G24 EE 8 ZA PWG syringe temperature Ch 2bl 9 8 PWG 33 Status wor 9 Sis Siucliuie or status WO Osetia dadas 9 9 Programming Me general sisi A 10 9 1 Principle of OD Cl AO WE 10 g2 MV ir e un EE 11 9 3 Device capabilities oocooocccnnniocnnioonnccnniconiconoconccnnrononnconconaronanecncinananos 11 O24 MiNMal TOW EE 12 9 9 SPUC Of DIA VCC WEE 12 Os Dia MaS Mi es 14 11 Examples of communication 15 ll Read device descriptos sia aan 15 11 2 Read chanel GSSCHPDION sacsvsesetescscseivevecpeteeeeceetcssecieeeneicew peieene ee eeeiseale 16 11 3 EE 16 Tes
29. to increase the maximal motor current Turn off the device and unplug power cord Remove the cover of the device as described at paragraph 10 2 2 Removing the cover Locate the Schneider Electric SD326 stepper motor controller Locate the Rotary switch 3 for setting the motor current User Manual Pulmonary Waveform Generator 10 Installation Use the rotary switch to select the desired motor current Pos Lei frei fin EC EEC EC O EC o A nb 2 0 factory default 24 WARNING Increase the current only step by step Test each setting Use the minimal current level that complies with your needs Never increase the current to levels that are causing even temporary mechanical deformations during waveform generation Reconnect power cord and turn on the device to test your settings using an adequate waveform Be careful while operating the generator with opened casing Jf the motor current is sufficient turn the device off remove power cord and reinstall casing Reconnect power cord 2 1 4 Humidifier only for PWG 33BT Before using BTPS simulation mode install the humidifier module in the following order Connect the heater module s electrical cable to PWG s humidifier port Connect the hose to the BTPS inlet of the device Fill the humidifier chamber with distilled water GG Assemble the humidifier module in the order shown on the scheme User Manual
30. to the output file Display device parameters Override input type as Volume Time ES ES ES EH e OvemideinputFieweney SSS FZ over inpa ow som for vz Over ip vom oom air OOO ES ES Inverse mode Define quarters for Sine and Square functions value is a 1 to 4 digit string used to select quarters of the full period Examples 1234 12 34 Copy output to device SS Wait for enter after done 8 Display help message User Manual Pulmonary Waveform Generator 67 Appendix 11 2 PWG Command line Controller PWG 33 Command line Controller is a small 32 bit DOS based application that can be used to control the PWG from command line PWG Command line Controller supports basic control tasks only Location PWG 33 Command line Controller is located in the installation folder of the main application Pulmonary Waveform Generatorlpwgcmd exe Usage PUT A Sole Sd E Folder Filel NN A O T WAKE SE TEMERE EO Ee A S B SaBTPSvanewRTPSint Move piston by a given Volume with a given Flow Flow can be a positive or negative floating point number Any decimal separators accepted TEMP Test temperature of Piston and Vaporizer Given temperature can be a floating point number Any decimal separators accepted Enter values of O to turn off heating W Wait for operation to complete Po Wait for enter after done User Manual Pulmonary Waveform Generator 68 Appendix 11 3 Software Interface
31. 06 ISO 2678207 1502673208 50267323 15026782118 S026782 41 15026782 12 8026782113 ATS24 05 ATS24 06 ATS24 1 150 Square Teszt SmeHatliter Sine Negyliter 1502678201 15026782 02 18502678203 1502678204 15026782 05 15026782 06 ISO26782 07 1502673208 ISO26782 09 1 026782 10 1S026782 11 1502673212 1502678213 Waveform library and Set list Use Waveform library and Set list to select the content of waveforms blocks Spirogram Shows the composed breathing pattern and a timeline Click on the Spirogram to select a block Zoom Clicking Zoom button shows a track bar to scale the Spirogram Waveform block toolbar Add a new or remove the selected waveform block Trash To remove a single waveform block from the Spirogram Use the mouse to drag n drop the block over the waveform trash Lung parameters Shows three basic lung diagnostic parameters that are describing the range of the syringe in which the piston will pass during waveform generation e TLC Total Lung Capacity the effective volume measured from the pneumatic outlet e FRC Functional Residual Capacity distance of the lower end of the first tidal breathing block measured from the pneumatic outlet User Manual Pulmonary Waveform Generator 49 Complete Spirograms e RV Residual Volume the volume of the unused range measured from the pneumatic outlet Apply changes and Recalculate Click to apply changes and recalculate Spirogra
32. 1l s User Manual Pulmonary Waveform Generator 44 Resistance test Described method Annex B Chapter 2 paragraph d Calculate the resi tance R tO flown tor cach reference flowrate n using Equation B 3 oy Oka Aref n B23 where Pn 1s the peak pressure for reference flowrate n Sata LS Eme rere renee ogrete woe low rare n To calculate this resistance values PWG s own internal resistance has to be measured first For details see chapter 7 3 2 Calibration of ISO Test profiles 7 2 User interface User interface of Resistance test mode collects the following features e Resistance testing e Measuring resistance of PWG during generation of ISO test profiles 2 PWG Manage Waveforms bt GI NORMAL lepers 7 ann 37 C E Tamo ZE C Pamo 1013 Po RHamp E E Cycle 0 f 3 dn Waveforms Riou Flow Resistance ca Sets E Tested Device Resistance of PWG Pal cr lative Resistance Pa Test Report 1 2 3 avg 2 3 avg Eff Res Pa Ba 1 s Sxpiration O 1 s 12 12 12 12 93 93 93 93 ER 3 50 Hs 36 36 36 36 193 193 13 193 156 5 00 1 s 71 TL 72 71 320 320 320 320 249 6 50 1 s 119 118 119 118 473 473 474 a 355 8 00 1 s 176 176 176 176 649 650 650 650 474 9 50 l s 244 244 242 243 851 851 851 851 BD 11 00 1 s 319 323 323 322 1072 1073 1075 1073 752 12 50 l s 413 412 416 414 1343 1344 1341 1343 929 ei 14 00 l s 529 527 527 528 1629 1629 1628 1629 1101 gt A 15 50 l s 651 649 647 649
33. 34 6 2 MANAGING WAV CTONMS sniene ads 34 6 3 el dun E sincncaicicseataliciaies initial ici aias 38 6 4 General WAV CTO INS stes a 39 6 5 NODOS aerea 43 7 RESISTANCE TEST eegen 44 ls ADOLE TOS atada 44 Vid WSOP NMC acesso asis 45 703 FENORMINO tt EE 46 7 4 EE 47 8 COMPLETE SPIROG RA Mess ad eo 48 8 1 About Spirogram editor EE 48 8 2 USC acts tonada 49 8 3 COMPOSING ele ele nn 50 8 4 Open Spa eee eee 52 8 5 Generating oprog ANS 2h iii 52 8 6 EDIO Sido nee ea ee ae ee ee 53 9 CUS TON WAVEFORMS icteric ieee enceaeee eee 55 9 1 About CUSTOM wa veiorms 55 9 2 WV AV CTOR MIO FO PE MI Sinai oc 55 9 3 Wavelorms parameters nadal 55 9 4 FNC TOMA oerna ere rac eto 56 9 5 Adding waveforms to Iran 56 9 6 EK ANG nto tibet laica traia E E e 56 105 MAINTENANCE crenn 57 TOS BASC as 57 AREND 59 US Va Le fe 60 O4 e EE 62 10 5 Troubleshooting GUAE verrerie nines 66 Wis APPENDIX a E 67 11 1 PWG Command line Waveform Compler 67 11 2 PWG Command line CGontroller 68 Feos SOWA nte HACC uti 69 11 4 USB Protocol epecifcaton 70 User Manual Pulmonary Waveform Generator 3 Introduction 1 Introduction Pulmonary waveform generator is the most essential equipment for developing and testing spirometers and other flow volume measuring devices PWG 33 is the ideal test equipment for R amp D companies for manufacturers and for authorized test laboratories as well The PWG 33 Pulmonary Waveform Generator provides predef
34. 4 ATS 26 ISO 26782 ISO 23747 e Second aspect is if BTPS simulation is turned on or not These results are then stored in a single report file 5 8 1 Contents of the reports Required contents of spirometer s test reports is listed under EN ISO 26782 2009 Annex B Section 5 Required contents of peak flow meter s test reports is listed under EN ISO 23747 2009 Annex B Section 5 PWG 33 provides test reports including most of the required measured or calculated test results however some tasks are requiring some subjective aspects to be performed Report header is including e Name and contact information of institute e Manufacturer type and serial number of the device being tested e Date and time of printing e Ambient temperature humidity and pressure Footer of the test is including e Responsible of the test e Comments e Signature User Manual Pulmonary Waveform Generator 31 Software overview Resistance test report is including e Report header e Report footer e Measured back pressure values for up to 5 passes for both phases of the test and for inspiration and expiration e Average pressure values e Effective pressure measured on test object e Calculated resistance to flow Waveform test report is including e Report header e Report footer e Temperature of syringe in BTPS simulation mode for each waveform e Measured parameters values for up to 5 passes e Calculated error for each value and for each pass e
35. 8625 V s e 1000 9 5 Structure of played file Waveform files are pure binary files containing series of steps see chapter PWG 33 Waveform Generator USB Protocol Specification 12 Data format The device reads all steps form the waveform file in a sequence The value red is separated into two parts rotation direction and timing Any data red generates one pulse for the motor instructing it to make one step into the requested direction and starts a timer to wait the time defined in the timing part of the step It is obvious that the timing part of the last step has no impact but its direction flag is used Waveform files can hold any breathing samples of any kind and any length including inspiration and expiration only the described device limitations must be kept You can use PWG Waveform Compiler pwgcc exe command line tool to convert Volume Time and Flow Time input files to binary data Example Playing 6 pulses Signs amp values Binary data in file 10000 7000 el 2000 0x00002FE0 10000 7000 3000 4000 8000 OD BG amp PWG 33 Waveform Generator USB Protocol Specification 13 10 Data transfer format If sampling is started the device sends all active channels data in the following format Device sends theoretical 00 P size P counter Ch identifier Ch data TJ Ch identifier Ch data Example 1 only the syringe pressure channel is active Data sent by device
36. E S RSS scsi cion Mies segs str NUL ENG TON Ola end Next step is to catch windows messages sent to the application Override main form s default message handler Override DefaultHandler TMainForm class TForm Jf ie A i Cis procedure DefaultHandler var Message override private public end Create the basic structure of DefaultHandler to preserve functionality of the application See description and implementation guide and for each command in the next section Embed their example codes into the following one Example procedure TMainForm DefaultHandler var Message begin with TMessage Message do begin 1f Msg WM_PWG_INTERFACE then begin 1f wParam write your code here end else inherited DefaultHandler Message end end Each command sent to the spirometer software is located in the unsigned 32bit integer value Message wParam An extra parameter for some commands is located in the unsigned 32bit integer value Message lParam PWG 33 Software Interface Developer s Guide 6 4 3 Initializing interface pwg_WM_INITINTERFACE Instructs the spirometer software to enter interface mode Message parameters wParam pwg_WM_INITINTERFACE lParam Handle to PWG Software The parameter lParam can be used when sending notifications for PWG Software Store it in the predefined variable PWG_APP Possible results pweCMD_OK initialization successful pwgCMD_FAIL unable to initialize Examp
37. Items description 0 i E E i User Manual Pulmonary Waveform Generator 6 Introduction Phases of operation Objects being tested must be connected to the pneumatic outlet A stepper motor drives the piston by a timing belt PC software converts desired waveforms to step delay time volume functions Converted waveforms are copied to an internal SD memory card built into the PWG Waveform generation can be started via o USB protocol PC software o Start button on the device o Remote Control Port optional PWG s microcontroller feeds a timer through a DMA with timing data read from the SD card The timer event sends a pulse to the stepper motor controller forcing the motor to make a step The generated waveform consists of consecutive steps Rotation of the motor is supervised by a built in photo interrupter and a stroboscope disc When step is impossible to perform due to the overload an error message is generated A heated humidifier is providing tempered and vaporized air for BTPS simulation The pneumatic syringe is also tempered to avoid condensation During BTPS inhalation the BTPS valve is opened towards the humidifier During expiration the BTPS valve is opened towards the pneumatic outlet Two extra photo interrupters are built in at constant piston positions for kinematics checking 1 5 General consideration on certain flow meters Some flow meters may show undesired side effect due the volume step
38. Pulmonary Waveform Generator 11 Installation CG ear 6 ID i 3 agent Conc supplier PBM pose zogen neet 022 a e mega Ian 8 sie comesor 220 20 mes m 2 2 Device drivers PWG 33 Pulmonary Waveform Generator is a composite device of a generic HID device plus a generic mass storage drive You do not need any device drivers to be installed on supported operating systems Connect the device to a free USB port of the computer User Manual Pulmonary Waveform Generator 12 Installation 2 3 Installing software Once the device is connected to the PC the built in SD card will be recognized as a mass storage drive Open My Computer Windows XP or Computer Windows 7 Locate the drive letter associated to PWG s SD card for example E Locate and launch pwg_setup exe Le Click Run Yes etc if security messages are asking for confirmation Bel User Account Control Sh AS Do you want to allow the following program to make changes to this computer C Program name PWG Setup Verified publisher Unknown File origin Hard drive on this computer Y Show details Welcome to the Pulmonary Waveform Generator PWG 33 Setup Wizard This will install Pulmonary Waveform Generator 1 00 on your computer It is recommended that you close al other applications before continuing Cick Next to continue or Cancel to ext Setup 2 Setup Pulmonary Waveform Gener
39. Pulmonary Waveform Generator PWG 33 and PWG 33BT User Manual e Installation e Maintenance e Operation e Technical files of firmware and software Piston Medical Ltd Sz l kert 4 b H 1033 Budapest Hungary Phone 36 1 275 00 33 w www pistonmedical com support pistonmedical com Created 01 03 2012 Version v1 00 Modified 24 04 2012 Contents 1 ERO DWC Hiel ds 4 1 1 Covered Standard Sada 4 1 2 Generated WAVET ON Sisa diia 4 1 3 EU TS ales AS 5 1 4 Principle Of operation cccceccceecceeeccececeeeceuecceeecseeceuseeeeesseesusenaeenaees 5 1 5 General consideration on certain flow meter 7 1 6 ECAT AN 8 Ss EIST Ol ee MES seminarista 9 1 8 Minimal Ge e eiis le dE 9 INSTALLATION ona ainia idas 10 Sch MSc AAA A E A A KEKA KE KHUN 10 2 2 Rate CIN GN Scorecard 12 2 2 MSAN SONWANE E 13 2 4 POS ENMStallkcon HUMO Nissan an 14 DEVICE OVER MEW escasas idad aio eT 16 3 1 DOSE ERE RE O EE DO Porn wee Pern reer rere Rarer 16 3 2 oie E 17 3 3 Error MICS Le E 19 3 4 cio AAA a nl is 20 VALIDA MON ato 21 4 1 Oe Lo eo AA oroen tnaro eeri raeadr 21 4 2 KIMematlles checa 21 SOFTWARE OVERVIEW sra aaa 23 Sl MENS AUTO Sres 23 9 2 NV CIC Oil eS Clee a 24 D Gio aisle Sle ile EE 24 5 4 Measurement windows oocooccoccconcococcnconconocanonconononnononanonrnnnncnnennnnanens 26 5 5 Ehe HEITE 29 5 6 RESCUE 30 5 7 DEvICS UNAS TOS 30 5 8 elei 31 QUICK TES tee 34 6 1 USCIS
40. Sample Stalin lirica 17 AMO e e e e ae do a 17 NR ee EE EE 17 T1272 ANOESUDOOMEG COM E le ME 17 12 AAA II SI 18 tite Gate RR e le tele E A aaa 18 12 2 Syringe pressure descriptor Chi 18 12 3 PWG status descriptor ChZ4 18 12 4 PWG syringe temperature Ch 19 PWG 33 Waveform Generator USB Protocol Specification 2 2 Brief protocol description PWG 33 is an USB composite device containing two functions e MSD drive e HID device Booth devices are using OS s integrated drivers to communicate with user software No additional drivers are necessary PWG 33 uses the following Vendor and Product IDs Vendor ID 0x04D8 Product ID OxF8D6 3 Communication The USB communication is packet based The maximum size of a packet is 64 bytes The device always sends and receives this 64 bytes However in most cases we do not use all the 64 bytes just the first few pieces of them all the 64 bytes has to be sent All packet starts with the following two bytes Ist byte bit 7 MSB 1 command or command response 0 data Ist byte bit 6 1 PC sent the packet 0 Device sent the packet Ist byte bit 0 5 Packet size 0 63 the real size is Packet size 1 2nd byte Packet counter The device uses two different counters one for the command packets and another one for the data packets 4 Send a command Commands are sent only from the PC to the device using the following structure UU P size P counter Command
41. a row and are mounted into a single waveform file 8 1 3 Type of blocks The following types of blocks are available Main block types e Tidal breathing accepts sine waveforms e Inspiration and Expiration accepts any waveforms or waveform sets Auxiliary block e Binding block automatically generated quarter period of sine used to bind tidal breathing and inspiration or expiration maneuvers or shift FRC point 8 1 4 Flexible architecture Based on the available blocks almost any frequently used lung diagnostic maneuvers can be simulated with PWG You can combine an unlimited number and type of blocks to get the desired breathing pattern When using waveform sets for inspiration and expiration blocks standard test profiles can be switched with a single click 8 1 5 Reporting Tests with complete Spirograms are producing the same test reports as Quick Test Beside the report files also Spirograms can be stored for later use User Manual Pulmonary Waveform Generator 48 Complete Spirograms 8 2 User interface User interface of the Spirogram editor Sai PWG Test device Compose Spirogram gt a Tested Device 3 Report ATS24 01 ATS24 02 ATS24 03 ATS2404 ATS2405 ATS24 06 ATS24 07 ATS24 08 ATS24 09 ATS24 10 ATS24 11 ATS24 12 ATS24 13 ATS24 14 ATS24 15 ATS24 16 ATS24 17 ATS24 18 ATS24 19 ATS24 20 ATS24 21 ATS24 22 ATS24 23 ATS24 24 15026782001 S026782 02 1802678203 SO267 204 15026732405 15026782
42. ator PWG 33 License Agreement Coa Read the license agreement Plesse read the folowing important information before continuing Please read the folowing License Agreement You must accept the terms of this agreement before continuing vith the instalation ND USER LICENCE AGREEMENT Select I accept the agreement Click Next Piston Medical Pulmonary Waveform Generator softwere end user licence cenputers and use it to operate medical devices by Piston Ltd I accept the agreement OI do not accept the agreement lt Back Next gt Cancel 2 Setup Pulmonary Waveform Generator PWG 33 Select Destination Location If required select a different destination folder Where should Pulmonary Waveform Generator PWG 33 be installed Or click Next to skip this step O SE wil instal Pulmonary Waveform Generator PwWG 33 into the following older To continue dick Next If you would like to select a different folder click Browse Browse i peu am PlesiPulmonary waverorm Generator the es At least 3 9 MB of free disk space is required lt Back Next gt Cancel User Manual Pulmonary Waveform Generator 13 8 Setup Pulmonary Waveform Generator PWG 33 Select Start Menu Folder Where should Setup place the program s shortcuts Setup wil create the program s shorbouts in the Following Start Menu folder To continue dick Next If you would like to select a
43. be for damages e Block the barb connector on the cylinder front plate and perform a quick leakage test Piston sealing e Perform the periodic lubrication process of the cylinder e Check the piston O ring e Clear the O ring groove on the piston Cylinder front cover sealing e Check the sealing groove on the cylinders front cover and if necessary scrape off the old grease and fill it with high viscosity heat resistant grease 10 5 2 Mechanical errors Linear motion jam e Check the mechanic for runaway particles and loosen screws e Perform the periodic lubrication process of the linear shaft e Check the roller bearings on the timing belt pulley Loud rattling noise e Check the timing belt pre tension e Stepper motor current is too low Loud humming sound e This is normal on high stepper motor current User Manual Pulmonary Waveform Generator 66 Appendix 11 Appendix 11 1 PWG Command line Waveform Complier PWG 33 Command line Waveform Complier is a small 32 bit DOS based application that converts standard waveform files to binary files used by the PWG itself Location PWG 33 Command line Waveform Complier is located in the installation folder of the main application Pulmonary Waveform Generatorlpwgcc exe Usage Pucon ame SO Ae e mom maca lee SMA Eed EE SA ende Eed A bee siege Define input file A VT FT F FZ VZ d C H Define output file default is input filename bin Append data
44. block will override this parameter e If an inspiration or expiration block is following the binding block it will start at this volume level In an FVC maneuver the binding block represents the full deep inspiration preceding the forced expiration e Click the button Add dV on the Waveform block toolbar The new block will be placed at the end of the Spirogram Use the mouse to drag n drop the new block within the Spirogram A binding block always starts at the position where the preceding block ends 8 3 6 Block sequence Block sequence in a complete Spirogram has some restrictions e As they start from a given volume level tidal blocks must be either placed manually to the correct position or they has to be preceded by a binding block Blocks can be reordered Use the mouse to drag n drop a block within the Spirogram After editing the Spirogram use the button Apply or Reorder User Manual Pulmonary Waveform Generator 51 Complete Spirograms 8 3 7 Deleting blocks To delete a block Select the unneeded block Click the button Delete on the Waveform block toolbar Or Use the mouse to drag n drop the block to the Trash 8 4 Open Spirogram To open stored Spirograms Use the main menu on Welcome screen to create a new or open an existing Spirogram 8 5 Generating Spirograms In many aspects generating Spirograms is very same to generating simple waveforms 8 5 1 BTPS simulation
45. cess device data E Customer Customer Ltd Tested device group Comments Responsible Write your comments here of the test De Customer Comments Report dates 3 2012 03 12 7 38 34 Waveforms 201 2 03 12 7 37 48 Resistance Report toolbar Date of tests New test f Store Report y Load RepN Pri User Manual Pulmonary Waveform Generator 30 Software overview History of entered data is automatically stored and Manufacturer Device type Customer and Tested by fields have auto complete feature Tested device group Enter Manufacturer model number and serial number if present of the tested device Customer Enter name and other data to identify the customer Comments Enter your comments in connection with the performed tests Responsible of the test Name of the person who performs or who validates the test Date of tests Date and time of tests performed Timestamp of resistance is recorded when the test was started Timestamp of waveforms is recorded when the last waveform was generated Report toolbar Load store and print functions 5 8 Reports Reporting functions are available on the Tested device panel of all measure windows PWG 33 is creating common reports for all tests performed The user can mix different test profiles and test modes as they are sorted automatically Sorting method e First aspect is the waveform group ATS 2
46. ct the piston with the External piston rod Repeat this step 20 times The loss of the volume due to the leakage can not be higher than 10 ml in a full stroke pro cycle 4 2 Kinematics checking Accuracy of the generator should be tested without load and with the maximal load To achieve the maximal load use a laminar artificial resistance 4 2 1 Principle of the test Measure piston s transit time between the two photo interrupters built in at dedicated points of the full range Just a TTL level frequency and event counter is needed to measure the time intervals There are two BNC connectors at the right side of the generator e The upper BNC connector Continuous MHz is an output with the basic clock frequency User Manual Pulmonary Waveform Generator 21 Validation e The lower BNC connector Gated 1 MHz is an output with the gated 1 MHz The two photo interrupters at the position of 1 liter and 5 liter gate out the basic clock frequency The time interval can be measured by a TTL level event counter The value of the LSB is 1 us 4 2 2 Calculation of transit times The kinematics checking of the equipment should be done in square wave mode The actual number of the steps between the two photo interrupters can be read out from the device as described in the section 2 4 1 Check device connection Read the actual number of the steps Nom between the two photo interrupters form the device Values of Num ar
47. cted parameters Enter a name for the new sine waveform Click Store to store the new waveform in Waveform Library or Click OK to close this window preserving modifications To reject changes click Cancel 6 2 4 Editing square waveforms C Saume move doine PEF ve O To modify waveform parameters click the Edit 1 Taema seme ier Hl C Trapeze wave define timing FYC waveform button bellow the graphs Trapeze wave define Tr Tf PEF FYC PEF 10 l s FYC 7 l The software distinguishes two different versions of square waves e Clean square waveform e Trapezoidal waveform Whereas PWG itself has some mechanical limitations peak acceleration and peak deceleration of the piston is predefined Thereby clean square waves also have small trapezoidal distortion however the software is automatically calculating the shortest raise and fall times First select the independent parameters to describe the square function Six options are available e Square wave define PEF FVC e Square wave define PEF FET e Square wave define FVC FET e Trapezoidal wave define timing PEF e Trapezoidal wave define timing FVC e Trapezoidal wave define Tr Tf PEF FVC User Manual Pulmonary Waveform Generator 36 Quick test Rest of the parameters is automatically calculated To finish configuration of square waveform Enter a value for the selected parameters Enter a name for the new squar
48. dal breathing cycles To add a new tidal block User Manual Pulmonary Waveform Generator 50 Complete Spirograms Click the button Add TV on the Waveform block toolbar The new block will be placed at the end of the Spirogram Use the mouse to drag n drop the new block within the Spirogram Use the mouse to drag n drop sine a waveform to the block A tidal block always starts on its FRC level 8 3 4 Adding forced in or expiration Forced inspiration and expiration blocks can contain predefined waveforms or a single cycle of sine and square waveforms They also accept waveform sets If a waveform set was added included waveforms can be selected by the two arrow buttons 4 and Y To add a new inspiration or expiration block Click the button Add FVC or Add IVC on the Waveform block toolbar The new block will be placed at the end of the Spirogram Use the mouse to drag n drop the new block within the Spirogram Use the mouse to drag n drop a waveform or waveform set to the block An inspiration or expiration block always starts at the position where the preceding block ends 8 3 5 Binding blocks Binding blocks are containing an automatically generated sinusoidal volume step to bind two other blocks Configurable parameter is V volume Volume level on what the quarter sine signal of the block should rise or fall e If a tidal block is following the binding block the FRC level of that
49. e For volume parameters 0 5 or 50 ml whichever is greater e For flow parameters 2 or 85ml s whichever is greater Additional error of BTPS simulation The additional error of the BTPS simulation according to referred standards e For volume parameters 1 0 or 100 ml whichever is greater Accuracy of the device under test The accuracy of results is calculated according to referred standards Deviation Deviation average standard Deviation S Deviation 100 average standard standard Repeatability of the device under test The deviation of results is calculated according to ATS publication Appendix B Expressions B1 and B2 Page 1128 Range Range maximum minimum Range Range 100 maximum minimum average Enabling error analysis Error analysis can be turned on or off for each parameters To enable analysis check the checkbox preceding the parameter s name 5 4 Measurement windows Both measurement windows Quick Test and Spirogram Editor have a common toolbar for controlling and monitoring basic functions of the PWG User Manual Pulmonary Waveform Generator 26 Software overview 5 4 1 Device control toolbar PWG s basic control functions are placed in the first toolbar group Zero position End position STOP operation Direction switch Direction switch PWG is able to operate in a so called Inverse Mode which means that any steps are performed in the oppo
50. e dedicated for each individual generator Read the actual step volume Vstep from the device Value is in ml Divide it by 1000 to get value in liter Create testing waveforms of 10 liters of volume and of different flows Measure the precise frequency f and pulse time Tmp of the Continuous 1 MHz output Calculate number of pulses Npuise n between the two photointerrupters for each flow rate n V Nominal pulse count N nom x Vie x f N pulse n 5 v 4 2 3 Examples Clicking Device Properties button at the welcome screen reports the following data Nnom 11532 steps Number of steps is dedicated for each individual generator Vstep 0 345 ml Measuring the continuous 1 MHz results f 1 000 063 Hz Calculations 1 liter s _ 11532x0 000345 x 1000063 ulsen S 1 N 3978565 pulses dn ABE Y E _ 11532x 0 000345 x 1000063 ulse n 5 N 795713 pulses User Manual Pulmonary Waveform Generator 22 Software overview 5 Software overview 5 1 Main features 5 1 1 Waveform library PWG software 1s cataloguing waveforms in the Waveform Library All waveforms have their own name Similar purpose waveforms can be grouped together Waveform groups are separated to factory default library and custom waveforms Catalogued waveforms can be then added to custom waveform sets Waveform sets can be used to test a couple of waveforms automatically 5 1 2 Generating periodic signals PWG 33 can
51. e of Quick test mode collects the basic features of PWG e Generating standard waveforms e Generating custom waveforms e Measuring flow resistance e Load store export and report functions Access waveform sets 4S PWG Manage Waveforms b gt NORMAL e Library Header toolbar 26 Ki 15023747 Access details of ra device being tested ra PEF 6 3860 S i EE FET 2 6580 D a 01 FEVI F YC 68 7353 Selected waveform DS o INIA ETS TONTO den CS y key d du 15026702 01 2012 03 12 7 38 34 Waveform ata Parameter Dim Ref Pass 1 Pass 2 Pase 3 Pass 4 Pass 5 Range Range Dev Der FEV1 1 4 894 4 894 4 094 4 094 n a n a 9 000 0 0 0 000 0 0 0 000 0 000 0 000 Waveform display 0 FEV6 13 7 120 7 120 7 120 7 120 n a nma gt Gs Gw with track bars 108 FVC 1 7 120 ease as aes Edit W v f rm gt D D LE P L 0 000 0 000 0 000 a e O ad y PEF 178 6 986 6 986 6 986 6 986 n a v u u uuU v u 0 000 0 000 0 000 CAVE FET s 2 658 2 658 2 658 2 658 n a 0 0 0 000 0 0 0 000 0 000 0 000 Nyon FEVi F C 4 68 735 68 735 68 735 68 735 n a E Pa dy 0 000 0 000 0 000 do Test Report Res Pa s 1 150 000 125 616 125 483 1250 254 n a n a 500 451 gt 13 flow l s 6 612 6 665 6 665 n a n a Dress kPa 0 831 0 836 0 835 n a n a Parameter Error quare FE 0 z been e Waveform toolbar 18026782 05 2012 01 26 11 25
52. e power supply Do NOT turn on the device press and hold the Control button Holding the Control button now turn the device on The Status indicator will start to blink briskly Now release the Control button Start the firmware update tool Follow the instructions supplied with the firmware to perform the upgrade process Turn off PWG wait 15 seconds then turn it on again Use the PWG configuration tool to restore device parameters see firmware release notes User Manual Pulmonary Waveform Generator 20 Validation 4 Validation There are two main factors determining the accuracy of the waveforms generated by the generator e Proper sealing e Proper movement of the piston 4 1 Check of sealing Sealing should be checked in the total stroke of the piston under a certain working pressure For this purpose a closed circuit constant pressure generator is needed The most convenient device for checking the sealing is a rolling seal spirometer with a weight on the upper moving part providing the necessary working pressure Install the rolling seal spirometer in a way that the movement of piston was vertical Calculate the appropriate weight which could provide pressure in the range of 800 Pa to 1 2 kPa Turn off the PWG Remove the white plug on the back panel turning with a coin Screw in the External piston rod Connect the spirometer to the PWG with a solid wall tube Push and pull till impa
53. e waveform Click Store to store the new waveform in Waveform Library or Click OK to close this window preserving modifications To reject changes click Cancel 6 2 5 Automatic analysis of entered parameters Entered waveform parameters are automatically evaluated If entered data or any that is calculated from them exceeds the limitations of device error messages are displayed including possible corrections at the bottom of the screen If an error can be corrected in more different ways all possibilities will be listed Example Creating a sine with PEF 20 1 s and FET 2 seconds will produce more than 25 liters of volume Since the device has a maximal volume of 10 liters the software will promote two options EWC 2xCeecs cevios lame Coreece Pm EWC exceescs casvicose lime Cortceci Im To automatically correct the error Double click one of the solutions above to correct your waveform Staying at our example selecting Correct PEF will order the software to change PEF value to 7 85 1 s preserving FET 2 in addition to get FVC 10 liters 6 2 6 Selecting standard waveform sets Standard waveforms can be accessed on the Waveform toolbar or similar to custom waveforms they are accessible in the waveform library too Click the proper tool button on the waveform toolbar or Click the arrow button at the left edge of the screen to show waveform library Open the Library section Select the group
54. eforms 9 1 About custom waveforms 9 1 1 Purpose PWG software allows creating unlimited number of custom volume time and flow time waveforms to meet all user demands and to comply with possible standards introduced in the future 9 1 2 Format Waveforms are described by its volume or flow data points as function of time Waveforms can contain positive and negative volume changes flow values with positive or negative signs inspiration and expiration maneuvers Sampling interval and reference values for lung diagnostic parameters must be defined 9 1 3 Requirements Device capabilities can be read from PWG e Piston volume e Peak flow e Maximal acceleration deceleration Always keep in mind these restrictions and never exceed them Also never define a flow rate of O I s Principle of operation is based on time intervals between two steps taken by the stepper motor Null value for flow will divide to an infinite time interval 9 2 Waveform properties Waveforms have the following properties ExpStart Experimental not used Zoom Default flow zoom 1 00 no change vZoom Default volume zoom 1 00 no change 9 3 Waveforms parameters minimum 10 Hz at least 500 Hz recommended 9 3 1 Parameter database Software install folder contains a CSV Comma Separated Values file called Params csv This file contains a list of parameters with name dimension acceptance range etc Select parameters you need from second colu
55. erature must always be higher than syringe s PWG 33 Waveform Generator USB Protocol Specification 4 PWG Read Status Ox0A04 OxDAOS OxOA06 OxOA07 OxOA08 OxOA0OA PWG Set File to play PWG Play Waveform PWG Set Speed PWG Go x Steps PWG Reset Motor PWG Send Status notify event 4 byte Status word 4 byte Status change word Ist byte 0 Set filename 1 Set Directory 2nd byte O terminated str Ist byte 0 default 1 filename 2nd byte Play count 0 endless Ist byte Goto zero speed timing 4 byte unsigned int Max directory depth level accepted Only 8 3 format filenames accepted Values under 1000 aren t accepted actual value is Ist byte Goto zero speed Ist byte Speed timing 4 byte signed unsigned int Sth byte Step count 4 byte Status word Notify Devices status change sent automatically PWG SLEEP Mode OxOAOB Ist byte 0 OFF wake 1 ON sleep OxOAOC Ist byte 0 Only stop 1 Stop and goto Zero 2nd byte 0 IN 1 OUT PWG STOP In sleep mode the controller turns the motor current off Stops any movement of the piston but does not stop the ambient valve PWG 33 Waveform Generator USB Protocol Specification 3 Available channels Name of channel Identification Description Resolution Comment number Extra descriptor Contains device name and serial number Syringe Pressure 19 2x16 bit of pr
56. essure sensors PWG status 24 32 bit status word details below 32 bit status change flags PWG syringe 25 16 bit of front All values temperature temperature are in C x 16 bit of rear 100 signed temperature integer 16 bit of syringe temperature 16 bit of humidifier temperature PWG 33 Waveform Generator USB Protocol Specification 6 7 Structure of channel descriptors Length of the channel descriptor is 60 bytes indexed 0 59 ch ID number S time LOW S time HIGH Channel specific area Ch size The current channel s size in byte Ch ID number Identification number of the channel Sample time Sample time in ms unsigned integer Active 1 Channel is active if sampling 1s started values are automatically sent 0 Channel is inactive values are never sent Channel specific area In this area are calibration constants and other user defined parameters stored Reserved Reserved for further development Non variable parameters Variable parameters Identification number Sample time Channel size Active Channel specific area PWG 33 Waveform Generator USB Protocol Specification 7 7 1 Extra Descriptors Ch00 Addresses within Channel dependent block Name of device string String 20 39 Serial number of device string String 7 2 Syringe pressure descriptor Ch19 Addresses within Channel dependent block Syringe pressure pressure sensor low Par B Real48 12 17 Syringe pressure press
57. he pneumatic outlet If switching to inverse mode any waveforms are generated in the opposite way e The piston is moved automatically to pump out position the closest position to the pneumatic outlet e Leading tidal breathing cycles are turned off User Manual Pulmonary Waveform Generator 41 Quick test e BTPS simulation is turned off e Pre defined waveforms are generated as inspiration maneuvers e The first half cycle of sine and square waveforms is generated as inspiration and the second half of them is generated as expiration e The button Zero position will move the piston to pump out position 6 4 6 Start or repeat test After selecting the desired waveform and waveform generation options To start waveform click the button Start waveform e The waveform will be downloaded to the device e Waveform generation will start automatically To repeat the last waveform without downloading it again click the button Repeat waveform e Waveform generation can be aborted any time by clicking the button STOP 6 4 7 Recording test results PWG software can record five series of test results for each waveform After each test the software pops a results table to enter measured parameter values Switch between parameters by pressing Enter on the keyboard to speed up data input Pressing Enter at the last parameter will close the window and record the entered parameters in the test report Enter Data
58. ined flow time and volume time waveforms for validation and calibration of Spirometers and other equipments measuring flow and volume 1 1 Covered standards Waveforms generated by PWG 33 and evaluations of test results are fully compatible with the following standards and recommendations e Standardization of Spirometry issued by American Thoracic Society on 11 November 1994 e EN ISO 26782 2009 Anaesthetic and respiratory equipment Spirometers intended for the measurement of time forced expired volumes in humans e EN ISO 23747 2009 Anaesthetic and respiratory equipment Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans former referenced as EN 13826 2003 Peak expiratory flow meters 1 2 Generated waveforms The PWG 33 generates the following standard waveforms e 24 ATS Standard volume time waveforms e 26 ATS Standard flow time waveforms e 13 Standard waveforms according to EN ISO 26782 2009 Annex C e 10 Standard waveforms according to EN ISO 23747 2009 Annex C profile A e User configured waveforms according to EN ISO 23747 2009 Annex C profile B User defined waveforms e Sine waveforms e Square waveforms e Volume time waveforms e Flow time waveforms Number of user defined waveforms is unlimited User Manual Pulmonary Waveform Generator 4 Introduction 1 3 Main features Extreme powerful design e Volume up to 101 e Maxima
59. ing tested form the pneumatic outlet Attach or leave on the pneumatic adapters that are required during the test to fit the test device but are not part of it in normal use Click OK after you verified the pneumatic outlet Measurement of PWG s resistance is now performed automatically Results of calibration are stored automatically Always repeat these test if pneumatic connector is changed 7 4 Reports After finishing tests e Store results e Print reports Resistance tests can not be suspended but calibration of ISO Test profiles 1s kept For details see chapter 5 8 Reports User Manual Pulmonary Waveform Generator 47 Complete Spirograms 8 Complete Spirograms 8 1 About Spirogram editor 8 1 1 Purpose Taking advantage of PWG s flexible and powerful design Spirogram editor was designed to make possible functional testing of spirometer software Among others complex waveform series can be used to e Create multiple flow level calibration sign for non linear flow meters e Test detection of different lung function test maneuvers in a single recording e Test calculation of lung diagnostic parameters computed or averaged from multiple maneuvers e Test control sequences of more sophisticated diagnostic systems 8 1 2 Principle of operation Spirograms are assembled from blocks Blocks are basic waveforms stored in the waveform library Before Spirogram playback waveform blocks are generated one by one in
60. ingle waveform alternately in and expiration maneuvers PWG software provides a Spirogram editing tool where the user can assemble complete Spirograms of multiple forced in and expirations tidal cycles and simple IC EC maneuvers 5 1 7 Support of ambient data measuring module PWG software supports PAM 201 ambient module that provides temperature relative humidity and barometric pressure data User Manual Pulmonary Waveform Generator 23 Software overview 9 2 Welcome screen The welcome screen collects the basic tasks in a single window IN PWG Welcome D 4 pen epee gt TY Ween aa R e ya E Quick test Quick test a device with standard ATS and ISO waveforms eate a new or modify an existing waveform manage your own aveform sets Create a new SD OO af eate complete spirograms to perform more complex tests Add waveforms and waveform sets to your project and configure test environment Open a project 0 pen an existing project Do a test or modify it e Q 5 2 1 Main menu Quick Test Open a Quick test to generate periodic signals sine square predefined waveforms or measure flow resistance See chapter 6 Quick test and chapter 7 Resistance test Create a new Spirogram Start here to create a new Spirogram See chapter 8 Complete Spirograms Open project Open an existing Spirogram 5 2 2 Buttons Device info Show device properties type serial number mechanical and pneumatic parameters etc
61. l breathing cycles and the main waveform of the test This defined amount of air will be inhaled between the tidal breathing cycles and the main waveform of the test Cycle count Define count of leading tidal breathing cycles VOLUME Click OK to apply settings The button Tidal will turn to green indicating that leading tidal breathing cycles feature is turned on Waveform data will be downloaded automatically this can take some seconds Or Click Cancel do close windows without activating leading tidal breathing cycles To turn off leading tidal breathing cycles later click the button Tidal button again The button Tidal will turn to back to grey 6 4 4 BTPS simulation Use the BTPS toolbar to enable BTPS simulation Desired temperature can be set any time BTPS check button is indicating if the device is ready for BTPS simulation Open temperature graph to check visually the warming up process If BTPS simulation 1s enabled e Leading tidal breathing cycles are turned off e If inverse mode was set PWG is set back to normal mode 6 4 5 Normal and Inverse mode In normal mode e Pre defined waveforms are generated as expiration maneuvers e The first half cycle of sine and square waveforms is generated as expiration and the second half of them is generated as inspiration e The button Zero position will move the piston to pump in position the farthest position from t
62. l flow rate of 20 I s Automatic operation e Full automatic resistance measurement e Full automatic calibration of PWG s internal resistance e Full automatic tests via software interface mode e Remote control port optional BTPS simulation optional in PWG 33BT e PWG is providing heated and humidified air e Adjustable air temperature Automatic evaluation of test results e error analysis e flow resistance calculation according to given standards Full support of individual control of the device e Public USB communication protocol e Utilities for data conversion e Command line DOS control tools Technical support e Software updates e Firmware updates are free of charge Sleep Mode PC software automatically sets PWG to a low power state after a given idle time In Sleep Mode the motor current is turned off Any commands will wake PWG from Sleep Mode 1 4 Principle of operation PWG 33 is a pneumatic syringe driven by a stepper motor Each step moves the cylinder by a constant volume of 0 345 ml This step volume equals to the theoretical volume resolution of the generator Desired flow rates are achieved by setting the precise delay time between two consecutive steps in a resolution of 12 5 ns Generated volume time and flow time waveforms are transformed to step delay time volume functions User Manual Pulmonary Waveform Generator 5 Introduction Block diagram
63. l result 1s calculated form the average of the particular values To start resistance test Click the button Start Test The following message will appear Remove any object being tested from the pneumatic outlet Remove the object being tested form the pneumatic outlet Attach or leave on the pneumatic adapters that are required during the test to fit the test device but are not part of it in normal use Click OK after you verified the pneumatic outlet User Manual Pulmonary Waveform Generator 46 Resistance test First phase of the resistance test is now performed automatically After the calibration has finished the following message will appear Connect the object being tested to the pneumatic SEH Click OK after you have connected the object being tested Second phase of the resistance test 1s now performed automatically 7 3 2 Calibration of ISO Test profiles Calibration of ISO Test profiles is performed in a single phase but it is only performed for the selected type of waveforms and only in the selected mode inverse or normal During calibration all test profiles are generated as many times as is set for resistance calibration To start resistance calibration according to the test following calibration Select normal on inverse mode Click the button 15026782 or ISO23747 The following message will appear Remove any object being tested from the pneumatic outlet Remove the object be
64. le if wParam pwg_WM_INITINTERFACE then begin EWG PEE PEro write your code here Result pwgCMD_OK end 4 4 Initializing measurement pwg_WM_INITIALIZE Instructs the spirometer software to run initialization tasks required for a measurement e g zero setting of the flow meter Message parameters wParam pwg_WM_INITIALIZE Param not used Possible results pwgCMD_OK initialization successful pwgCMD_FAIL unable to initialize Example 1f wParam pwg_WM_INITIALIZE then begin TE write your code here then Result pwgCMD_OK else Result pwgCMD_Fail end PWG 33 Software Interface Developer s Guide 7 4 5 Starting measurement pwg_WM_STARTMEASURE Instructs the spirometer to start collecting samples Message parameters wParam pwg_WM_STARTMEASURE lParam not used Possible results pwgCMD_OK measurement started successfully pwgCMD_FAIL unable to start measure Example if wParam pwg_WM_STARTMEASURE then begin if write your code here then Result pwgCMD_OK else Result pwgCMD_Fail end dp Stoping measurement owg WM_STOPMEASURE Instructs the spirometer to stop collecting samples and calculate results Message parameters wParam pwg_WM_STOPMEASURE lParam trigger event Trigger events l normal stop waveform ended 2 user cancelled Possible results pweCMD_ OK measurement done calculating results pwgCMD_FAIL unable to calculate results Example if wPara
65. le position Remove the pneumatic outlets You can adjust the preload on the inside tensioner O rings with a sheet of metal or with a coin 10 4 2 Replacement of PTFE rings in BTPS valve PTFE rings should be replaced if they are excessively worn or scratched Unscrew the 6 screws with 4mm hex key Carefully pull off the front plate of the BTPS valve User Manual Pulmonary Waveform Generator 62 Maintenance The rollers with their shafts should be put back in place if they fall off Treat the sealing surfaces with lubricant Replace the PTFE rings Replace the tensioner O rings too if necessary Pull the spacer rings on the screws and screw the front plate back to place Use a rod to center and hold in place the PTFE rings during the operation 10 4 3 Replacement of piston O ring Use O ring only specified by the manufacturer or equivalent in size and type e Trelleborg ORARO0443 189 9x7 mm NBR 70 ShA The O ring seal of the main cylinder should be replaced after every 1 000 000 cycles or after a failed leakage test Remove the piston rod from the linear slide using 5 mm hex key User Manual Pulmonary Waveform Generator 63 Maintenance Unscrew the 4 screws on the cylinder s feet with 5 mm hex key Disconnect the temperature sensor on the cylinders back end Loosen the grub screw on the fixing element with 3 mm hex key Unscrew the fixing rod from the cylinder s back e
66. let Interchangeable pneumatic plug for receiving objects that are being tested Cooling air inlet Never cover ventilation openings Cover The removable housing covers the top and both sides of the device Cover mounting screws The four hex socked bolts placed in the four upper corners are fastening the cover User Manual Pulmonary Waveform Generator 16 Device overview 3 2 Front panel Complete set of controls and indicators of the front panel are shown on the following figure Some of these controls are optional Status indicator Mains switch Y Control button Heating indicator O Remote control port L HH REMOTE CONTROL Pump end TON IN PISTON OUT position bh indicators Humidifier port USB plug O Calibration ports Available on PWG 33BT Available with remote control option 3 2 1 Basic components Mains switch The mains switch interrupts the power supply of the device To turn on the device switch it to position I Humidifier port Power supply and data interface port of the humidifier USB plug Connect the waveform generator to the PC s USB 1 1 compatible port User Manual Pulmonary Waveform Generator 17 Device overview 3 2 2 Indicators LED light indicators are displaying basic status information about the PWG LEDs can be turned of they can light or they also can blink with different frequencies Status indicator e Lighting status indicator refers
67. m pwg_WM_STOPMEASURE then begin if write your code here then Result pwgCMD_OK else Result pwgCMD_Fail end PWG 33 Software Interface Developer s Guide 8 4 7 Reporting results pwg WM RESULTAVAILABLE Spirometer software notifies PWG Software that the results are calculated and the export file is written to the disk Message parameters wParam pwg WM_RESULTAVAILABLE lParam Result of reporting If result calculation fails the parameter lParam must to FF Other values are preserved for further development Example Sending notification SendMessage PWG_APP WM_PWG_INTERFACE pwg_WM_RESULTAVAILABLE pwgCMD_OK 4 8 Closing interface owg WM_DISCONNECT Both software may notify the other that the interface is closed for example due to exiting the application Message parameters wParam pwg_WM_RESULTAVAILABLE lParam not used Example 1 Sending notification SendMessage PWG_APP WM_PWG_INTERFACE pwg_WM_DISCONNECT 060 Example 2 Receiving notification if wParam pwg_WM_DISCONNECT then begin write your code here Result pwgCMD_OK end Using the interface Once the interface is configured a new button Connect to Spirometer software appears on the Welcome screen Click the button to launch Spirometer software Open a Quick test Select a Waveform group of Waveform set Starting a waveform will automatically initialize the spirometer and start the measurement Use
68. m parameters Store project Click to store the Spirogram Start waveform Download the complete Spirogram to the device and start waveform generation Repeat waveform Repeat the last downloaded Spirogram 8 3 Composing Spirograms 8 3 1 Creating a new Spirogram To create a new Spirogram Use Quick test screen to create each special sine and square waveform that are required for your project If finished VOLUME On the Welcome screen select Create new Spirogram The Spirogram editor will appear Enter a name for the Spirogram m308d 1831 Compose your Spirogram lt You can use the button Store project any time to save your changes 8 3 2 About waveform blocks Each waveform blocks have a header and a display area The header contains the configurable parameters of the block and the display area shows the waveform itself To select a block click either the display area or any controls placed in the header For drag n drop operations always drag the display area 8 3 3 Adding tidal block Tidal blocks are the basic elements of a Spirogram containing a sine waveform starting at a definable breathing level A Spirogram begins typically with a series of tidal breathings Configurable parameters are FRC level Exact vertical position of the tidal breathing can be defined The first tidal block added will determine the FRC level of the whole Spirogram Cycle count Number of ti
69. mendation does not regulate the way resistance has to be measured ISO standards are describing some methods to determine if the tested device is having resistance to flow below a specific limit To start resistance test open Quick Test and click Resistance test tab 7 1 2 Configuration To configure resistance test e Open software setup from the Welcome screen e Chose the tab Resistance test setup For details see chapter 5 3 4 Configuration of the Waveform Generator 7 1 3 ATS recommendations According to ATS publication Chapter Equipment Recommendations Table 2 Page 1111 the resistance of the flow meter can not exceed the limit of ky Sele ZO AS ore O lea des Use resistance test to determine resistance to flow 7 1 4 Measuring resistance according to ISO standards According to standard ISO 26782 Chapter 7 9 Expiratory impedance The expiratory impedance of the SPIROMETER Meca es O SS Ee lalo Me alas shall not exceed 0 15 kPa 1 s for the defined test Pror eS dished trab le late elos up be As Described method Annex B Chapter 2 paragraph d Record the pressure throughout each defined test prometen des Ee Een ies ACCESSORIES and detachable partes atwached Measure the peak impedance once the 1 0 1 volume has been discharged According to standard ISO 23742 Chapter 7 3 Resistance to flow The resistance to flow across the measurement range of the PEEM shall not exceed 0 35 kPa
70. mn of the file Further information on CSV files can User Manual Pulmonary Waveform Generator 55 Custom waveforms be found on Wikipedia http en wikipedia org wiki Comma separated_values Contact the manufacturer if you need to expand this table with new parameters 9 3 2 Reference values In the waveform file all parameters that must appear in the test report must be listed including reference values for them 9 4 File format Waveform files have a standard windows INI file format header and parameter descriptor section plus a data section listing all the data points of the waveform e Decimal separator for all values can be o period full stop dot US decimal separator sign o comma European decimal separator e Section and variable names are all case sensitive 9 5 Adding waveforms to library To add your custom waveforms to PWG waveform library Copy your files to c Program Files Pulmonary Waveform Cenerartor WOmetroma Sulome Les You can create one level of subfolders 9 6 Example Header Group 15026782 mod Name 02 Jeer Freq 500 ExpStart 0 fZoom 1 68 vZoom 0 89 Parameters EENS oe EE SS HAS or so COO COC Oral PVC 5 6 LIS SOO UCONN O SZ E DEEN HERE OOOO O CN 2 AL HE SIN OUCICONONOG S FEV1 FVC 63 1668307099999993 Data 0 0000000 OOO ISO OSC SIL GS User Manual Pulmonary Waveform Generator 56 Maintenance 10 Maintenance 10 1 Basic tasks
71. ms Waveform data Waveform data field shows pre defined parameters of the waveforms These are the reference values for test reports Waveform control Waveform control toolbar collects basic control functions as Start or repeat waveform generation For details see chapter 6 4 Generating waveforms Edit waveform Edit waveform button shows waveform properties in a separate window After editing the modified waveform can be named and stored in the library 6 2 2 Sine and Square waveforms To create a new custom Sine or Square waveform click the proper tool button on the waveform toolbar Select parameters Group Sine Define PEF FYC Name F10 20 Define PEF FET Former defined sine and square waveforms can be mun accessed in the waveform library er Es Click the arrow button at the left edge of the screen to show waveform library Open the Custom section CARE Ee Select the desired group Sine or Square Select the desired waveform User Manual Pulmonary Waveform Generator 35 Quick test 6 2 3 Editing sine waveforms To modify waveform parameters click the Edit waveform button bellow the graphs First select the two independent parameters to describe the sine function Three options are available Define PEF FYC Define PEF FET Define FVC FET The third parameter is automatically calculated To finish configuration of sine waveform Enter a value for the two sele
72. n e Suggested quantity Spray one 1 second Procedure Apply the lubricant specified in the above section or silicone spray through the pneumatic outlet to the surface of the valve Turn the device off and then on Startup procedure will move the BTPS valve that will smooth the lubricant Repeat the two previous steps a few times Linear bearing and shaft Turn off the device Remove the cover as described at paragraph 10 2 2 Removing the cover Clear the shafts from dirt and add some machinery oil on it or use the lubricant specified in the previous sections Move the linear slide between the end positions with your hands back and forth a few times Wipe excess oil off the shaft ends and replace the cover 10 1 3 Quick leakage test The manufacturer recommends performing a quick leakage test after a long term storage or transport Turn off the device Remove the white plug from the back panel turning it with a coin and screw in the external piston rod Block the pneumatic outlet with your hand Strongly push the piston rod and hold it for minimum 10 seconds with a nearly constant force to generate a nearly constant pressure in the cylinder After that push it again stronger a second then use the previous constant force again The piston rod should move in then return to the previous position Repeat the test in both directions If leakage test fails then see the troubleshooting guide on
73. nce Diagram Resistance diagram show the measured resistance in function of flow The graph is displayed for inspiration in green and for expiration in red 7 2 1 Resistance test control UDP Start 18023747 New Test Start Test Calibration of ISO Test profiles New test Clear current Resistance test results Use New test also if configuration of resistance test has been changed Opening a former report will override default settings Repeating a test will be also done according to the method stored in the report file Start test Start automatic measurement of resistance to flow Previous data will be overwritten Calibration of ISO Test profiles Start automatic measurement of PWG s own resistance to flow according to methodology of the referred ISO standards Previous data will be overwritten Calibration must be performed manually for both normal and inverse mode according to your current needs 7 3 Performing tests 7 3 1 Resistance test Resistance test 1s technically performed in two phases e First phase is measuring the internal resistance of PWG plus the pneumatic adapter if necessary e Second phase is measuring the total resistance of the generator the pneumatic adapter and the object being tested Resistance test is performed with a flow rate increased in equal steps between a minimum and a maximum level Resistance at each flow rate is measured several times with and without the object being tested Fina
74. nd User Manual Pulmonary Waveform Generator 64 Maintenance Turn the cylinder about 30 degrees taking care of the cables connected to it Unscrew the 4 nuts on the tightening screws with 13 mm wrench and remove the cylinder s back end Pull out the piston and remove the old O ring seal Before replacing it clear the inside surface of the cylinder and the groove on the piston from old lubricant and dirt After replacing the piston put the back cylinder plate in place and loosely screw the nuts on the tightening screws You can align the two cylinder end plates to place and tighten the screws on the cylinder s feet Tighten the nuts on the tightening screws User Manual Pulmonary Waveform Generator 65 Maintenance 10 5 Troubleshooting guide 10 5 1 Potential leakage points In case of a failed leakage test the following examinations should be performed Drain valve e Check if the valve is closed e Check the drain tube for damages e Block the barb connector on the cylinder bottom and perform a quick leakage test without the drain valve BTPS valve e Check the connection and the O ring sealing of the pneumatic connectors e Perform the periodic lubrication process e Check the slider plate position and if necessary readjust the pre tension on the PTFE rings e Perform a visual check on the PTFE rings in action and replace they if necessay Pressure transfer tube e Check the tu
75. of desired standard Select the desired waveform User parameterized waveforms can be modified and then stored to a different group on a different name Use the arrow buttons Tal and P to select next waveform in the current group 6 2 7 Selecting custom waveforms Custom waveforms are accessible in the waveform library Click the arrow button at the left edge of the screen to show waveform library Open the Custom section Select the desired group Select the desired waveform User Manual Pulmonary Waveform Generator 37 Quick test User parameterized custom waveforms can be modified again and then stored to a different group on a different name Use the arrow buttons Tal and P to select next waveform in the current group 6 3 Waveform sets Different waveforms can be categorized into waveform sets Waveform sets are used to collect waveforms that are frequently tested together To manage waveform sets select the Sets tab Access Set list Set details 2 PWG Manage Waveforms aie E K NORMAL Qerse a T Tpistord 37 CES Tamp 25 C Pamp 1013 b s RHami 50 SE pi du Waveforms Ra Flow Resistance I S a Tested Device A Set list SetName Waveforms Name AWATS ATS24 01 ATS24 02 ATS24 03 ATS24 04 ATS24 05 ATS24 06 ATS24 07 ATS24 08 ATS24109 ATS24 10 ATS24 11 ATS24 12 ATS24 13 ATS24 14 ATS24 15 ATS24 16 ATS24 17 ATS24 18 ATS24 19 ATS24 20 ATS24 21 ATS24 22 ATS24 23 ATS24 24
76. of the required flow rates for example 1 5 l s and 6 l s and define a proper FVC Create a new Spirogram Add two tidal blocks Drag n drop the two sine waveforms For both of them set FRC level to O liter to minimize signal distortion effect of back pressure 4 9 4 Set the number of cycles to the required count d Store and test curve logba logosi 1 1 Tool 1 I oots 1 oral toes 1 toon 8 6 2 Calibration signal three constant flow rates Create three square waveforms having PEF of the required flow rates for example 1 5 I s 5 I s and 10 I s and define a proper FVC Create a new Spirogram Add three expiration blocks Drag n drop the three square waveforms Store and test curve 10 0000 User Manual Pulmonary Waveform Generator 53 Complete Spirograms 8 6 3 Full FVC maneuver with ISO 26782 test profiles Create a sine waveform for tidal breathing cycles L L L L Create a set containing all ISO 26782 curves Create a new Spirogram Add the following blocks O Tidal FRC 5 1 Count 4 Binding Volume 9 Forced expiration Forced inspiration Binding Tidal FRC 5 1 Count 2 Drag n drop ISO 26782 set to both expiration and inspiration blocks Browse the sets to select a test profile for both inspiration and expiration Store and test curve User Manual Pulmonary Waveform Generator 54 Custom waveforms 9 Custom wav
77. ome device related parameters should be set before the first use To change this settings perform the following steps Click the button Configure the Setup dialog box will pop up Choose the tab Device setup Return to zero speed Speed of the piston in l s moving to basic zero position This setting is stored in the device itself option is only available if the device is connected Default value is 5 l s BTPS inspiration speed Speed of the piston in 1 s during inhalation of heated and vaporized air Default value is 0 5 l s Adjust this option carefully as too high values can lead to step error or direct water inhalation Store piston temperature log Piston s temperature 1s logged when the PWG application is started This log can be stored for later analysis Default value is No Enter sleep mode after When the PWG application is started the device is set to Sleep Mode after the idle time that was set here User Manual Pulmonary Waveform Generator 15 Device overview 3 Device overview 3 1 Design Main components of the device are shown on the following figure Cover mounting Cover screws Cooling air inlet 7 O O 30 Front panel BTPS inlet Pneumatic outlet Front panel The most important controls and indicators of the PWG are placed on the front panel BTPS inlet BTPS inlet is the pneumatic plug that receives the humidifier s flexible hose Pneumatic out
78. on steps Activating the Interface will perform the following tasks e Launch of spirometer application e Check for started process running e Find the handle HWND of the window e Send initialization command PWG 33 Software Interface Developer s Guide 3 3 2 Measurement control After startup the Spirometer application is waiting for commands The test is started manually by the user PWG Software Spirometer software Start and initialize Spiro app interface Wait for Wait for test start test start Initialize Download waveform Do zero setting Wait for test start Start measure Start measure wi Generate Do the test waveform Stop measure Stop measure Wait for Write Calculate results Export results Test done Notify only Wait for reply PWG 33 Software Interface Developer s Guide 4 Operation steps e A waveform is downloaded e Spirometer is instructed to prepare for measurement PWG Software is waiting for the result of spirometer s initialization process If initialization fails the test is interrupted e PWG is prepared for the test zero setting move to start position BTPS inhalation The spirometer is waiting for measurement to be started e Spirometer is instructed to start the measurement PWG Software is expecting a result code If initialization fails the test is interrupted e The PWG is generating the waveform the s
79. pirometer is collecting flow samples e When the waveform was generated the spirometer is instructed to stop measure PWG Software is expecting a result code If the measurement succeeded the PWG Software will suspend the test process e The spirometer software is calculating test results and writes them to an export file e The spirometer software is notifying the PWG Software about the test file was created e PWG Software is reading test results and resumes the test process 4 Implementation guide This chapter will show step by step how to implement PWG Interface in any application Examples are written for Object Pascal Delphi 4 1 Define constants and variables The following constants are used by the interface Windows message string constant str_WM_PWG_INTERFACE WM_PWG_INTERFACE Commands constants pwg_WM_INITINTERFACE pwg_WM_INITIALIZE pwg_WM_INITDONE pwg_WM_STARTMEASURE pwg_WM_STOPMEASURE pwg_WM_RESULTAVAILABLE pwg_WM_DISCONNECT Command replies constants pwgCMD_OK SOL pwgCMD_ FAIL SFF Result status constants OVRE NONE OO pwgRES_WAIT Ol cis IONE T Or PWG 33 Software Interface Developer s Guide 5 Variables PWG APP HAWND WM_PWG_INTERFACE DWORD 4 2 Prepare the interface First step 1s to register the str_WM_PWG_INTERFACE windows message using RegisterMessage API call in the main unit s initialization section Register a custom message initialization INE TECAT
80. r the set Adding waveforms to the set To add new waveforms Open waveform library Use the mouse to drag n drop waveforms to the set details list Reorder waveforms within a set To reorder waveforms within the set Use the mouse to drag n drop waveforms within the set details list Remove waveform from set To remove a single waveform from the set User Manual Pulmonary Waveform Generator 38 Quick test Use the mouse to drag n drop the waveforms over the waveform trash Clear waveform set To remove all waveforms from the set Double click the waveform trash Store set Click the button Store set to save changes of waveform set 6 3 2 Delete set To delete a waveform set Select the waveform from the set list Click the button Delete set 6 3 3 Using Waveform sets Stored Waveform Sets are listed in the waveform library under the top level node Sets To work with these waveform sets select one of them from the library Waveform sets are behaving like Waveform Groups Click the arrow button at the left edge of the screen to show waveform library Open the Sets section Select the desired Waveform Set Select the desired waveform Use the arrow buttons Tal and P to select next waveform in the current group 6 4 Generating waveforms The waveform control toolbar is used to configure leading tidal breathing cycles and to start or repeat waveform generation 11 MAA Tidal
81. site direction For example this makes it possible to generate standard waveforms as inspiration maneuvers Zero position In consideration of the actual direction of waveform generation moves the piston to zero position farthest position from the pneumatic outlet End position In consideration of the actual direction of waveform generation moves the piston to the end of the syringe closest position to the pneumatic outlet Easier to say in inverse mode the two buttons Zero position and End position are working in the opposite way STOP operation Immediately stops any movement of the piston 5 4 2 Ambient toolbar Ambient data toolbar group shows the actual ambient parameters that will be showed in the report and displays the syringe s actual temperature Show Temperature Enter ambient Graph data Triston Tamo 25 0 C Py 1014 2 RHamp 50 SET _ _ _ rr _ _ __ _ Temperature of Actual ambient syringe parameters User Manual Pulmonary Waveform Generator 27 Software overview Temperature of syringe Shows weighted average of syringe s thermometers Show Temperature Graph Shows a temperature time graph in a separate window Actual ambient parameters Last entered or actually measures ambient parameters Enter ambient data Displays an input dialog for entering the current ambient parameters temperature barometric pressure and relative humidity Barometer Sle
82. sssssseeeeeeeneessssssssssssssseees CEIC Relative humidity of air with BTPS smulanon 92 wE Distance between photo interrupters for verification nominal value 127 mm 1 6 3 Environmental conditions The equipment complies with the EN 606001 1 1997 standard Transporting conditions EE 30 C 60 C Relative DIM ds 10 100 non condensing Ambient PLE SS EE 500 1060 mbar Storage conditions Renne asii iria 0 C 50 C errereen 10 85 AMbDIENT EES geegent iia 500 1060 mbar Operating conditions Temperi Ure AAA PP EA 10 C 35 C Relative Hundred 30 75 Ambient ENEE 700 1060 mbar 1 6 4 Electrical data Nominal voltage SWitChable A A 115 or 230 VAC Mains voltage tolerance at 115 VAC anniina 100 130 VAC Mains voltage tolerance at 230 VAC EE 170 240 VAC NEE 50 60 Hz EEN ee max 25VA Power consumption PWG 33BT iia max 7 0VA 1 6 5 Mechanical properties Size Without humidifier occcccncccoocnnnnnnnnnnnnnnnonnnnnnnononononinonnnss 1100 mm x 370 mm x 265 mm VN A Shape tah aera tape a ees Open den et io ae eee Aenea dena eae Adee aerate 38 kg User Manual Pulmonary Waveform Generator 8 Introduction 1 7 List of accessories PWG UE l set Externa rp OnT aisla T E l piece USB TEE l piece AA A E 1 piece built in SOM Wa dilo On the built in SD card NSS Manta A EE E copy Additional items for PWG 33BT Heat CTV ene ue in l set Tubing connectors as listed in the sec
83. t the user software has the possibility to trigger on the status change PWG 33 Waveform Generator USB Protocol Specification 9 Example If a command was sent to move the BTPS valve to ambient position but it already was there the following events will be fired 1 Valve in ambient position CLEAR 2 Valve in ambient position SET The Change flags Valve in ambient position bit will be set in both cases 9 Programming the generator 9 1 Principle of operation The PWG 33 is a step motor driven syringe Exact flow is achieved by the known volume of steps following each other after a proper timing Generated waveforms are series of timing intervals Waveforms must be copied to the built in SD card The default file is waveform bin placed into the root folder Calculatiuon of timing Example 0 345ml 80000000 Hz x 1000 The following commands are using these timings e PWG Go x Steps Ox0A08 e PWG Set Speed Ox0A07 e PWG Play Waveform OxOA06 PWG 33 Waveform Generator USB Protocol Specification 10 9 2 Data format Timing values are stored in 32 bit unsigned integers DWORD with the following supplement The 31st bit MSB is indicating the direction of rotation These 32 bit data units are called a step bit 0 30 SIGN Delay time in main clock Sign and directions Sign 0 Sign 1 Interpreted as breathing on PWG side 31st bit Inspiration OO Expiration 9 3 De
84. t frequency and that causes proportional increase in flow This goal of this feature not to create exact lung diagnostic parameter values but to unveil a cheat based on shape recognition of ATS curves observed in connection with some poor quality spirometers According to this lung diagnostic parameter values are not recalculated yet 6 4 3 Tidal cycles PWG software provides leading tidal breathing cycles preceding the main waveform of the test simulating a real forced expiration maneuver ahead with some normal breathing cycle Click the button Tidal to open the tidal breathing cycles setup box Waveform Open editor FRC level IC level Cycle count Waveform Tidal breathing cycles are generated from previously defined sine waveforms stored in the Waveform Library Follow the steps described in chapter 6 2 Managing waveforms to create predefined sine waveforms Select an item from the drop down list Open editor Click the button Edit to change waveforms parameters User Manual Pulmonary Waveform Generator 40 Quick test FRC level Define FRC Functional Residual Capacity of the Lung level of the Spirogram formed by this tidal breathing cycles and the main waveform of the test The piston will be moved towards to its end position prior to waveform generation This feature is also allows reducing dead space of the piston IC level Define IC Inspiration Capacity level of the Spirogram formed by this tida
85. tion 2 1 4 Humidifier ssssnnnsnosssseoeeessssssssseeeees 1 set 1 8 Minimal PC configuration Operatines stc ai Nada Windows XP Vista 7 Computno capacity usara ba See operating system recommendations IS e EEN booth 32 and 64 bit supported Pree e Ree Eer ne EE 1 port User Manual Pulmonary Waveform Generator 9 Installation 2 Installation 2 1 Installing device 2 1 1 Appropriate placement PWG 33 should be positioned so that at least 10 cm distance is kept around the ventilation openings on left and back side Always place PWG 33 on a stable horizontal surface Keep in mind that weight of the device is close to 40 kg 90 pounds and due to the high acceleration of internal mechanical parts it might cause horizontal shake of the table maximal momentum of 0 6 kgm s 2 1 2 Selecting mains voltage Mains voltage is factory set to 115 or 230 VAC Factory setting can be checked on the yellow label next to the power connector WARINIG Connecting the device to improper line power will damage the Schneider Electric stepper motor controller To switch mains voltage contact the manufacturer for detailed instructions 2 1 3 Adjusting motor current Under special application conditions the device might require extra power to generate high speed waveforms without step error for example working with high flow resistance test object at high flow rate In such situations the design of the device provides the possibility
86. ure sensor high Par A Real48 18 23 Syringe pressure pressure sensor high Par B Real48 Pres suso e UR ena de where R is the 16 bit A D value of syringe pressure channel 7 3 PWG status descriptor Ch24 Addresses within Channel dependent block Calibration steps step Unsigned integer 16 bit Main clock frequency Hz Unsigned integer 32 bit Peet Maximum flow 1 s Real48 PWG 33 Waveform Generator USB Protocol Specification 8 7 4 PWG syringe temperature Ch25 No channel descriptor present for this channel on demand these bytes can be used to store any data Temperature C R 100 where R is the 16 bit signed value of syringe temperature channel n 8 PWG 33 Status word The device has a 32 bit status word and a 32 bit Change flag The status word is sent any time when at least one bit changes in it The Change flag is indicating the bits that are changed within the status word The status word can be also queried any time by the Read Status Ox0A04 command 8 1 Structure of status word Bit Use the PWG Reset Motor 0x0A09 command 5 _ Valve in ambient position S O _Valve in BTPS position 0 7 10 Going zero position 14 Switch pressed after command PWG Play Waveform Ox0A06 Device can not perform the command 19 31 not used SE Status change events occur even if there was no real change in the devices physical condition so if the physical status change must be wai
87. vice capabilities Device capabilities can be read from the device by querying the channel descriptor of the PWG Status channel Never exceed devices physical limitations These parameters can be device specific so it is recommended to read these parameters anytime you connect to a device Maximum BTPS inspiration speed l s O 000 Calibration steps step Number of steps between the two midway opto gates Main clock frequency Hz Frequency of the waveform generators main circuit Use this value to calculate step timings from flow values Maximum flow 1 s Maximal flow rate of the PWG Exceeding this speed might result step errors Extreme range violation can cause mechanical deformation Peak acceleration 1 s Calculate speed s raise time for a given flow using this constant Peak deceleration 1 s Calculate speed s fall time from a given flow using this constant Step volume ml Exact volume of one step Sum volume I Pneumatic dead space of the syringe Available volume 1 Volume available for waveform generation PWG 33 Waveform Generator USB Protocol Specification 11 9 4 Minimal flow rate On the one hand the minimal flow rate is O l s On the other hand the PWG 33 is a step motor based system where we only can speak about average flow over a given time interval However if we define a minimal frequency fmin for steps we can calculate a minimal flow rate Example 0 345ml x 25Hz 0 00
88. y to implement and easy to use standard for all manufacturers using PWG 33 and leaving further developments at customer side avoiding later compatibility issues 2 3 Brief description PWG Software Interface keeps control on PWG s side PWG Software plays the master role while spirometer acts as slave The master controls the slave via standard windows messages Main phases of communication are e Connect Disconnect e Initialize pre measurement tasks like zero setting of flowmeter e Start Stop Cancel measure e Reporting results via a standard PWG waveform file 2 4 Configuration of Interface acl Institute data TA Acceptance criteria Ra Resistance test setup The following information is required for PWG Ph vevice emp BI Device into P Software Interface Software to start the interface his feature was designed for use by developers and manufacturers only Interfacing other applications is requiring implementation of PWG s Software interface communication protocol based on standard windows messages For amp Application to be launched details see the User Manual a Application path P PistonXP Languages bat ul Command line parameters to be passed Command line parameters i Window title PistonXP e Title of window to communicate with O TIRE e Path to report file Principle of operation PWG Software Interface can be activated from the PWG Software See PWG 33 User Manual for details 3 1 Activati
89. you can close the software Load the test results later Continue working with the same device This feature can be used if testing multiple devices See chapter 5 5 6 Testing multiple devices 5 8 4 Printing test report Click the button Print to open Print Preview window Print preview shows both waveform and resistance test report Printing options also can be set from here Preview settings Paging Print setup Print test report A Print Preview DER dei PULMO HAR Y WAVEFORM GENERATOR 2012 04 10 15 35 08 Page 143 a m Se a ae ay Pulmonar y Waveform Compratasr Tested device Manufacturer Device type Serial Number ss Time ofttest 2012 00 05 13 55 42 Customer Measurement of flow resistance Ambien conltionz 250 C 1011452 450 Resistance of PWG Cumulative Resistance Flow Gass 1 E 3 aug 1 2 3 a g Efectha Ree Etanca l Fa Pa Pa Pals Expiration 1 00 1 10 1 20 1 30 O Page 1 of 3 Preview settings Preview settings toolbar provides different zoom levels for the selected page Paging Use paging toolbar to navigate between the pages of the report Print setup The button Print setup pops a standard windows Printer Setup dialog for selecting and configuring printer and for select pages to print Print test report Starts printing test report with the specified options User Manual Pulmonary Waveform Generator 33 Quick test 6 Quick test 6 1 User interface User interfac

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