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User`s Manual - Piston Medical

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1. O EIL TA I 8 1944 m _IS 1982 ouk LA MN IS 1501 USB EAM d N q amp 1808 IS 1984 a N dM PRT 3000 IS 1573 lt E IS 1930 lt rd So EN i _ 18 1174 Part number Description IS 1944 Bacterial and viral filter IS 1920 Check valve IS 1984 T part with pressure port PRT 24 Mouth pressure filter fitting VM 3434 Mouth pressure bacteria and viral filter IS 1982 T part IS 1174 High pressure tube IS 1573 Corrugated tube IS 1930 Mouthpiece PRT 40 Tygon tube for pressure meter PRT 3000 One way valve IS 1501 Nebulizer pot green 3 5 micron IS 1503 Nebulizer pot purple 1 2 micron Piston Lung Function Test 16 Installation When inserting the check valve pay special attention to the appropriate opening and closing direction The cone shaped connection parts must fit tight paying extra attention to the secure sealing Place one of the check valves into the T part without the pressure release port Place the other check valve into the T part with the pressure port Place the corrugated tube onto the T part with the pressure port Fit the mouthpiece to the other end of the corrugated tube Fit the T part without pressure port to the stirrup Fit the other T part into the stirrup Piston Lung Function Test 17 Installation
2. ion Menu 3 v PARAM REF M 01 9o RSD M amp 03 9e F 2 Or FVC 4 40 417 95 4 04 92 Ive 4 58 426 98 4 08 89 Navigator FEv 5 272 277 FEV 1 0 3 48 333 96 3g 95 P d FEV 0 5 IVC 63 84 67 82 FEV 0 5 FVC 65 18 68 44 atient ata FEV 1 0 IVC 76 77 78 13 102 81 42 106 FEV 1 0 FVC 76 77 79 78 104 82 17 107 PEF 8 59 10 41 121 9 06 106 BTPS data 5 8 FEF 25 75 3 66 3 13 86 0 00 0 mn FEF 75 7 57 9 32 3 8 60 114 FEF 50 4 60 4 62 100 FEF 25 1 80 1 17 65 Complex curves EET mu MTT 0 95 0 59 62 5 01 529 FIVC 4 26 Graph FIV 0 5 7 1 Ja settings e y Side by side Best mm Control Spirogram Information panel Device selector Select the device to be used from the drop down list This is necessary if for example you own a Plethysmograph and a Spirometer and would like to perform IVC measurement Zero setting Runs manual Zero setting of the selected device Without manual Zero setting the system automatically sets zero before all measurements Menu The program s general main menu which contains the grouped basic functions Navigator Controls that group the basic phases of daily routine Patient data Contains the most important measurement data for the patient selected from the database Piston Lung Function Test 52 User interface BTPS data These are the environment data measured by members of the PDT 111 device family If you only own the PDD 301 device this is where
3. Fit the bacterial and viral filter onto the exhalation side The filter prevents the exhaled agent to enter the environment Fit the appropriate colour nebulizer pot Connect one end of the compressor pneumatic tube to the one way valve and connect the one way valve to the nebulizer head Connect the other end of the mouth pressure tube to the device s MOUTH PRESSURE plug Connect the mouth pressure tube to the T part with the pressure port The mouth pressure sensor s filter protects the device s internal parts Connect the other end of the mouth pressure tube to the device s MOUTH PRESSURE plug Insert the other bacterial and viral filter onto the compressor s intake port This ensures that the compressor is not contaminated Piston Lung Function Test 18 Installation PDT 111 p and PDT 111 d Patient circuit Item Part number Description Comment 1 FM 15000 HM Flow sensor 2 Valve manifold 3 SV 36 Valve disc 4 Measurement head holder with metronome 5 CV 35 A B Demand valve sealing Only for diffusion capacity test 6 MSAOELA 96 N Demand valve Only for diffusion capacity test Piston Lung Function Test 19 Installation PDT 111 p and PDT 111 pd Cabin placement Place the plethysmograph warily Since extremely small pressure differences have to be measured in the plethysmogram cabin external interference adversely affect measurement accuracy T
4. 1 Esophageal Balloon Catheter 2 Stylet Y connector 3 Extension tube 4 Syringe Glass 5 cc The set does not contain it 5 Three way Stopcock 6 Pressure transducer tubing Preparation Have available for use a nemesis basin tissues a protective drape topical anaesthetic water soluble lubricant and a 1 to 5 cc glass syringe a glass of water and a straw Select a naris with the best airflow for catheter insertion If necessary apply a suitable topical anaesthetic e g 2 4 Lidocaine Spray to the patient s nasal passage and throat Remove the sterile radiopaque catheter with the stylet from its protective sleeve from the catheter and discard Remove the yellow protective sleeve from the catheter 1 and discard Apply water soluble lubricant to the distal tip of the catheter 1 With the patient s head in a neutral position or flexed slightly forward slowly insert the catheter 1 through the naris and hypo pharynx using a gentle advancing motion The insertion may be easier if the patient is sipping water thru the straw Avoid placement of the catheter 1 in the trachea Tracheal placement can be identified by patient choking or airway obstruction causing an increase in airway resistance and pressure To estimate depth in which to place catheter calculate the product of the patient s height x 0 288 For example the patient is 175 cm height the principal depth is 50 cm Piston Lung Function
5. ECG _ ARDIAX List of records Measurement process After select an existing or record a new patient in the database Launch the IMED Cardiax external ECG software by selecting the ECG option on the Navigator Follow the instuctions in the Manual of the ECG software to perform ECG recordings Piston Lung Function Test 121 PRE POST PRE POST The PRE POST measurement The system supports measurement comparison previous measurements may be compared against measurements made later Select the patient Select and load the PRE or previous measurements Measure the current POST values with the patient Select the two measurement to be compared Print the PRE POST report Retrieve measurement Perform the steps in the Patient database page 62 section Open the database Select the patient Select one or more measurements Load the measurement results Max 8 measurements may be displayed simultaneously so if you loaded 6 measurements you can perform 2 more measurements Notice The program also makes it possible to print the PRE POST report from the actually performed measurements Report compilation A Warnings Ad Setup N Animation Miller Quadrat 3 a Parameters a Instructions 737 PRE POST PRE 4 2007 03 05 13 27 48 Measurement selection _ I POST TTEN Quick keys DARA BH s v vi FYC 5 24 5 68 6 17 0 49 P ter list IVC 5 48 5 62 s 5 85 0 23
6. Manual Dilution queue Dose Dilution queue mg m mg ml Type of head y 9 Purple 1 2 micron 0 12 g min Material of Solution Green 3 5 micron 0 3 g min M Agent s name and properties Select the provocation agent from the scrolling down list Value of the maximal dosage in the Max field and status of the Accumulate checkbox are retrieved automatically but they can be modified on request New agent To enter a new agent click on the New button Specify the maximal allowed dosage Specify if the agent has an accumulating effect Specify the bronchial diluting agent at the Solution section If you are going to enter only a bronchial diluter you have to leave empty the Material section To save click on the Add button or on the Cancel button to abandon changes Mode Auto If the provocation is done by the PDD 301 p dose controlled drug nebuliser Manual If the provocation is manually done without dose controlled drug nebuliser Type of test There are different kinds of provocation test to select Fix concentration Patient inhales more and more dosage from the fix concentration agent Dilution queue 2 minute Patient inhales higher and higher concentration from the agent for 2 minutes by occasions Piston Lung Function Test 116 Measurement modes Dilution queue Dose Patient inhales increasing concentration and dosage from the agent Setting the fix concentration Using the Fix co
7. PRE POST evaluation To load the data for all previous visits check the All measurements checkbox This displays a patient s all previous measurements sorted according to the following e Date e Measurement mode e Measurement results quality Select the results of at least two identical measurement mode for example two FVC measurements Load the data as mentioned earlier PRE POST measurements are detailed in the PRE POST section Page 122 Comment field for patients Comments may be entered about the patients even for every visit All comments are stored separately in the database and may be retrieved individually To enter a comment e Open the Patient database e Selected the desired patient Click the Diagnose button to open the text editor window e Select the Patient operating mode from the list e Enter the comment e Press the Store button to store the comment Previous diagnosis All previous comments about the patient may be retrieved from the History list The currently entered text is not lost when viewing a previous diagnosis To display the currently entered text again select the Patient option from the list of operating modes again Piston Lung Function Test 66 Calibration CALIBRATION After turning the device on and entering the BTPS data calibration is recommended for maximum measurement accuracy Calibration is recommended when starting a new shift after flow s
8. User s Manual Supported devices PDD 301 s Spirometer PDD 301 r Rhinomanometer PDD 301 sco Breath CO monitor and spirometer PDD 301 rco Breath CO monitor and rhinomanometer PDD 301 p Dose controlled drug nebulizer PCD 702 Combo Device PDT 111 p Whole body plethysmograph PDT 111 d Diffusion capacity test PDT 111 pd Whole body plethysmograph and diffusion capacity test Piston Ltd 1033 Budapest Sz l kert u 4 b Rev 3 06 02 0197 Nov 30 2010 TABLE OF CONTENTS Table of CMC CIM scien oor Donee ees eb tovto oh toe atn ees bebe Io E ERE VEN ERR AR 1 Introductio t rne ro edo ten reunir ua et eiie sea IR REY o EQ INR Ra UR 4 Ib uc e Q 4 Symbol annotation is tessera NALE ma esa IANUE EX NBN ea ES EA Ee Rp era Det De Eee eMe n 2 Techmcal oVer91e Wc ostii uter ioa nor MP UG ud reditu actae out Rap Eurus 6 InstallatIOH ices ssasssievenesctssedevscseadsseerosinvensotesis siosaia evt vu erases as e eei ed Gan 8 BG CHIC shock protection ais escorts Proc NUES BP aed ere booa Pete a Rune 8 Minimum PC configuration esses rennen enne nnne 9 PDD 301 s Spirometer installation itecto uteri ete terea pado 10 PDD 301 r Rhinomanometer installation eene 12 PDD 301 sco and PDD 301 rco Breath CO monitor installation 14 PDD 301 p Dose controlled drug nebulizer installation 15 PDT 111 p and PDT 111 d Pa
9. for 25 cycles 5 Uy gt 95 dip in Uz for5s Not applicable Mains power quality should be that of a typical commercial or hospital environment If the user of the PDD 301 r Rhinomanometer requires continued operation during power mains interruptions it is recommended that the PDD 301 r Rhinomanometer be powered from an uninterruptible power supply or a battery Power frequency 50 60 Hz magnetic field IEC 61000 4 8 Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE Ur is the a c mains voltage prior to application of the test level Piston Lung Function Test 133 EMC Guidance and manufacturer s declaration Guidance and manufacturer s declaration electromagnetic immunity The PDD 301 r Rhinomanometer particular implementation PDD 301 s Spirometer is intended for use in the electromagnetic environment specified below The customer or the user of the PDD 301 r Rhinomanometer should assure that it is used in such an environment IMMUNITY HEC C000 Compliance Electromagnetic environment guidance test test level level Portable and mobile RF communications equipment should be used no closer to any part of the PDD 301 r Rhinomanometer including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended s
10. l s l s kPa l s 1 kPa s 0 19 A 89 10 6 51 RSD 1 25H 0 034A 2 92 0 85 RSD 5 50H 0 030A 1 11 0 90 RSD 3 22H 0 025A 1 60 1 35 RSD 2 45H 0 025A 1 16 1 10 RSD 1 05H 0 025A 1 11 0 69 RSD lt lt 0 22 fupper limit gt gt 1 04 lower limit mmol min kPa 8 18H 0 049A 2 74 1 17 RSD 0 49 RSD mmol min kPa l 0 004A 2 24 Reference values for Arotock published in 1984 Boys IVC FVC FEV 0 5 FEV 1 0 FEV 1 0 IVC PEF FEF 50 FEF 25 Girls IVC FVC FEV 0 5 FEV 1 0 FEV 1 0 IVC PEF FEF 50 FEF 25 Where A age H height I I I I 76 l s l s l s l l l l l s l s l s 18 years 70 years 145 cm 180 cm children from Pulmonology Child Care by G K 0 0405H 0 051A 3 65H 0 00542H 0 2049A 0 3306 0 0299H 2 98 0 04H 3 99 1 09H 4 897A 35 58 0 0823H 6 87 0 0543H 4 58 0 0282H 2 31 0 0279H 0 0909A 2 554H 0 088H 0 1307A 0 3761 0 0299H 2 98 0 04H 3 99 1 23H 4 48A 37 83 0 0823H 6 87 0 0448H 3 37 0 0248H 1 86 6 years 18 years 110 cm 185 cm Piston Lung Function Test 162 Appendix l Knudson January 1984 female male height centimetre age year PERT NORM FVC Co m gt x lt Age Equation 95 C I 6 10 0 0430M 3 7486 11 19 0 0416M 4 4470 0 0699A 20 69 0 0444M 3 1947 0 0169A 2 70 0 0313M 0 1889 0 0296A 6 11 0 0409M 3
11. tH n3 CO 4 CT CD 4 ow k ce n3 e Q e Correct MVV measurement The patient breaths quickly evenly during the measurement Piston Lung Function Test 87 Measurement modes Rhinomanometry Measurement goal The goal of the measurement is resistance to get the patient s nasal airway Piston ical Dr Semmelweis Ign c EERO vocor bell Patients E v z Setup Help 2007 08 02 12 19 20 vi I A T V E Patients Rhinomanometry x eee John 75kg 178cm BTPS 27C 999 hPa 40 wissen 0 ig 00 0 00 Heec PRE POST Wemer ET Setup i roofs aa Parameters amp Instructions D Audiometry setae pa i O Date PARAM L 1 R 1 SUM 1 L amp 2 R S a DBAL 1 C Flow 50 223 98 216 73 440 71 200 48 19 E J 2 9 Fow 75 309 89 298 01 607 90 280 27 27 ES exit Flow 100 382 57 364 06 746 63 344 81 33 I amEEEEE OW 150 497 21 477 28 97449 455 47 44i 1 O Flow 300 726 66 695 44 1422 10669 00 64 2 Ov RES 50 0 22 023 O11 025 O02 m im VIRES 75 0 24 0 25 O12 027 Oz UN QE EE MEI CU SE NONE RUE pal RES 100 0 26 0 27 0 13 029 O0 RES 150 0 30 0 31 0 15 0 33 0 3 RES 300 0 41 0 43 0 21 0 45 0 4 eee 1000 De Display Single graph O Side by side Full graph Marker Vel bd Volume Time gt I ni a Ls v 30 Ba een a oan eee Er rM E ts vocac En
12. Flow when 25 of the forced vital capacity is still in the lung Piston Lung Function Test 36 The program s main functions FET Forced Expiratory Time The duration of forced exhalation MTT Mean Transit Time The average leaving time from the lung of gas molecules during forced expiration FIVC Forced Inspiratory Vital Capacity Inspired volume after full expiration at the highest possible flow FIV 0 5 Forced Inspiratory Volume 0 5 sec The amount of air inhaled during the first 0 5 seconds of forced inhalation FIV 1 0 Forced Inspiratory Volume 1 0 sec The amount of air inhaled during the first 1 0 seconds of forced inhalation PIF Peak Inspiratory Flow rate Highest inhalation flow speed during forced inhalation FIF 25 75 Forced mid Inspiratory Flow rate The average flow calculated for the middle half of the forced inhalation The following graphs are displayed during measurement e Volume time curve e Flow volume loop Static vital capacity EIL D The most widely used method for the static lung function test Detailed description may be found in the Measurement modes page 82 section In this operating mode the device measures the following parameters IVC Inspiratory Vital Capacity Total inspired volume after a full expiration IRV Inspiratory Reserve Volume The inspiration reserve volume is volume what the patient can inhale from the average inhalation endpoints of quiet breathings ERV Expiratory Reserve Vo
13. If you do not accept the agreement exit the installation You can specify the install destination Click Next You can select which part of the program to install experienced users Click Next You can enter the name the program appears under in the Start menu experienced users Click Next Piston Lung Function Test 27 Installation ie Setup PistonXP Select Additional Tasks Which additional tasks should be performed Select the additional tasks you would like Setup to perform while installing PistonXP then click Next Additional icons v Create a desktop icon ie Setup PistonXP Ready to Install Setup is now ready to begin installing PistorXP on your computer Click Install to continue with the installation or click Back if you want to review or change any settings Destination location c Program Files 85 NPistoriXP Setup type Full installation Selected components Microsoft SQL Server 2000 Desktop Engine Borland Database Engine 5 11 Program Files Start Menu folder Piston Medical ia Setup PistonXP Installing y Please wait while Setup installs PistoriXP on your computer Extracting files c Program Files PistonXP PistonXP exe Hn 18 Setup PistonXP Installing Please wait while Setup installs PistoriXP on your computer Install Oracle XE Database Server This can take several minutes You can select whether a P
14. The ratio of residual volume and total lung capacity FRC Functional Residual Capacity Function residual capacity FRC TLC The ration of Function residual capacity and total lung capacity Single Breath Tlco Transfer factor of the lung for CO The lung s transfer factor for carbon monoxide The SI unit of measurement mmol min Pa Dico Transfer factor of the lung for CO The lung s transfer factor for carbon monoxide The imperial unit of measurement ml min mmHg Klco Transfer coefficient of the lung for CO Transfer coefficient BHt Breath hold time Effective time breath hold time Intra Breath Tico IB Transfer factor of the lung for CO The lung s transfer factor for carbon monoxide The SIunit of measurement mmol min Pa Dico IB Transfer factor of the lung for CO The lung s transfer factor for carbon monoxide The imperial unit of measurement ml min mmHg Piston Lung Function Test 40 The program s main functions Klco IB Transfer coefficient of the lung for CO Transfer coefficient Auxiliary parameters supporting evaluation of measurements WOV Wash Out Volume Wash out volume FACH4 Expiratory concentration CH4 Exhaled CH4 concentration FACO Expiratory concentration CO Exhaled CO concentration CCCH4 Calibration constant of CH4 channel CH4 channel calibration constant CCCO Calibration constant of CO channel CO channel calibration constant GSL Gas Sample Lag Gas sampling time displacement CHA
15. objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the PDD 301 p drug nebuliser is used exceeds the applicable RF compliance level above the PDD 301 p drug nebuliser should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the PDD 301 p drug nebuliser Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Piston Lung Function Test 142 EMC Guidance and manufacturer s declaration Recommended separation distances between portable and mobile RF communications equipment and the PDD 301 p drug nebuliser The PDD 301 p drug nebuliser is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the PDD 301 p drug nebuliser can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the PDD 301 p drug nebuliser as recommended below according to the maximum o
16. 05 50 1 83 52 3 29 43 y Provok ci Potlasztasi id 10 15 11 07 Old s Csapv z 4 41 100 3 66 100 8 87 100 Bel gz si id 0 00 Gt K zik nyv Hat aryso 0 000 mg ssz hat anyag 0 000 mg Audiometria Hat anyagmennyis g 0 0100 mg I A Nyomfat Kil p s i i The result table of the Provocation test contains the following items Time of the measurement date hour minute Name of the provocation and or diluting agent Dose Value of the 1 parameter Percentage of the 1 parameter to the basic value Value of the 2 parameter Percentage of the 2 parameter to the basic value Value of the 3 parameter Percentage of the 3 parameter to the basic value Piston Lung Function Test 114 Measurement modes Provocation flow chart Settings of the test Basic measurement il Agent inhalation Lung function test and resumed o0 Ea ao Oo 2 on 9g Q c H 92 e 8 D N Sequence can be suspended Yes Bronchial dilution Control lung function test Diagnosis Saving results Printing report Piston Lung Function Test 115 Measurement modes Setting of Provocation test Prior to starting a Provocation test parameters should be set click on the Settings tag ei Parameters ax Instructions 9 PRE POST Warnings Ak Name of material Max Type of material Y ma CAccumulat Mode Type of test Auto O Fix concentration Dilution queue 2 minute
17. 3 877 3 9809VH 0 1485VA 1 322Fi 0 108 Ln PEF l s 0 411 1 793ln H 0 4251In A 0 910Fi 0 146 Ln MEF 75 l s 0 455 1 616In H 0 3738In A 0 861 Fi 0 164 Ln MEF 50 i s 0 256 1 643In H 0 3481In A 1 089Fi 0 206 Ln MEF 25 i s 0 772 2 002In H 0 3063In A 0 409Fi 0 284 FEV 4 0 FVC 9233 4 850 Piston Lung Function Test 169 Appendix l Sweden National Hedenstr m Malmberg 1985 Formula Reference value B1 A B2 log A B3 H 4 C A Age years H Height metre B1 B2 B3 C according to the table below B1 B2 B3 C Woman mpFVC 0 00982 0 6358 1 4137 0 832 mpFEV10 0 0092 0 4772 1 3284 0 9296 mpFEV10IVC 0 00096 0 2223 0 1233 2 1533 mpFEV10FVC 0 00062 0 1586 0 0853 2 0975 mpPEF 0 00677 0 4017 0 7422 0 9661 mpFEF50 0 00741 0 3471 0 8581 0 9336 mpFEF25 0 01548 0 3431 0 8498 0 7966 mpPIF 0 00909 0 6156 1 1867 0 8731 mplVC 0 01016 0 6995 1 4518 0 7763 Man mpFVC 0 00827 0 586 1 4468 0 9461 mpFEV10 0 00587 0 2756 1 1655 1 098 mpFEV10IVC 0 00246 0 3553 0 3095 2 1933 mpFEVi1OFVC 0 0024 0 3104 0 2813 2 1519 mpPEF 0 00211 0 1049 0 6774 1 3255 mpFEF50 0 00041 0 3087 0 148 1 3415 mpFEF25 0 00771 0 2819 0 0252 1 0597 mpPIF 0 00484 0 2715 0 9965 1 2709 mplVC 0 00833 0 6309 1 475 0 9047 Piston Lung Function Test 170 Appendix l Finnish National Viljanen 1981 Female FEV1 FEV1 IVC FRC FRC TLC FVC Ln Gaw V Ln Raw MEF25 MEF50 MEF75 MTT MVV
18. 64 ves MBTPs 29 ce 992 jhPa 33 lem LE Te l inis edu ecce PREIPOST A Figyelmeztet sek ET Be ll t sok He Spirometria i j1 P Param terek g M r si Instrukci k oa aiiis i Otam PARAM REF M 01 96 RSD za Nyomiat e e al 13 Mv T TLC 5 43 5 30 98 ERN i IPIE eve ee P MEE T TGV 2 87 3 60 125 ES Kil p s am i ae i IRV 2 10 EE 2 a FRC 2 87 2 39 83 4 y 4 Cdyn 2 04 EU i Edyn 0 49 3 UE 3 ra Cstat 3 40 D E Estat 0 29 E swear ee E w 0 67 Fi Req 1 1 f Cdyn TLC 38 49 aoe Cstat TLC 64 05 t Cdyn FRC 85 41 ee kPa kPa Cstat FRC 142 14 a hy ij eee ENERO Ic EE NU 2 Cdyn TGV 56 64 o 7 Cstat TGV 94 26 mm Temp 27 83 Hum 29 40 V Teljes g rbe Megjelen t s Press 994 77 Only Anais OE Loa Rs iem 1 00 T rfogat Id eo DynCorr 1 00 a mu st ini jm a aai iEn id Teed re EST deere Sees eet ee 8 oto Ts Piston Lung Function Test 105 Measurement modes Oesophageal balloon We propose the following oesophageal balloon for the Compliance meaurement Manufacturer Cooper Surgical Trumbull CT06611 USA Tel 1 203 601 5200 Decricption Esophageal Balloon Catheter Set Type 47 9005 Of course any other type of oesophageal balloon can be used but the current description is relevant only for the specified type Parts of the Esophageal Balloon Catheter Set
19. D S T IS ELFOGADJA EZEN SZOFTVERTERMEKEK AZ AL BBIAK 9 accept the agreement O I de not accept the agreement 15 Setup PistonXP Select Destination Location Where should PistoriXP be installed pem Setup will install PistoniXP into the following folder To continue click Next If you would like to select a different folder click Browse Ca At least 105 9 MB of free disk space is required 18 Setup PistonXP Select Components Which components should be installed Select the components you want to install clear the components you do not want to install Click Next when you are ready to continue Full lation v v Oracle XE 14944 MB Database server 1 494 4 MB Client components only 77 2 MB USB drivers 0 8 MB PistoriXP program files 10 6 MB User s manual 40 3 MB v English 156MB v Deutsch 10 2 MB L v Maavar 145MB Current selection requires at least 1 548 8 MB of disk space lt Back Next gt Cancel 18 Setup PistonXP Select Start Menu Folder Where should Setup place the program s shortcuts Setup will create the program s shortcuts in the following Start Menu folder To continue click Next If you would like to select a different folder click Browse Piston Medical lt Back Next gt Cancel Carefully read the License Agreement click I accept the agreement and click Next
20. Enter the exact environmental pressure value and click the OK button Resistance Calculation This is where you can set the algorithm used to calculate Resistance loop slope Method by Matthys Resistance loop is intersected with 0 5 l s flow value and place the steepness indicating line on the geometric bisecting points of the horizontal intersections Lis Method of Peak pressure We place the steepness indicating line on max the peak value points of the pressure measured in the cabin Method of Maximum flow We place the steepness indicating line on the maximum flow points Calibration time interval You can set how often the device should remind you of the need for calibration Piston Lung Function Test 59 Settings Diffusion capacity meter D Select the Diffusion group in the Setup Options Devices menu The following device operation related settings are available CH4 concentration Original methane concentration of the test gas mixture CO concentration Original carbon monoxide concentration of the test gas mixture Wash out volume WOV The volume the device releases from the start of expiration until the beginning of gas analysis Breath hold time BHt The period of breath holding or closing the shutter BHt calculation method Since diffusion in the lung starts from the beginning of inhalation and lasts till the end of expiration the system offers several algorithms to calculate the effective dif
21. Minimum Recommended Operating system Windows XP Processor for 600 MHz Intel Celeron Pentium 3 Core 2 PDD 301 family family AMD K6 Athlon Duron family Processor for 1 GHz Intel Celeron Pentium 4 Core 2 PDT 111 family family AMD KoO Athlon Duron family Screen resolution 1024x768 1280x1024 Printer Windows compatible Colour Internet connection For software updates Piston Lung Function Test 9 Installation PDD 301 s Spirometer installation PPE 18 PBF 30 MPA 30 1 Fo 3 pee PR T 75 POD 301 S ll ASEOS US U PPE 18 6 fc LC GV Y PA COO j 1 Connect the USB cable to the device and to the PC Connect the blue connector of the twin tubing to the blue coded socket indicated with the Flow meter label and the white connector to the white coded socket For the proper connection the lock should be turned 180 degrees clock wise For the connection push the PinkFlow flow meter into the quick connector For removal push the metal button Piston Lung Function Test 10 Installation The PinkFlow flow meter can be used without bacterial filter as well In this case a clean PinkFlow meter should be installed prior to each patient Connect one MPA 30 mouthpiece to bigger diameter end of t
22. Test 106 Measurement modes 10 11 12 13 14 15 16 17 18 19 20 21 Advance the catheter 1 to the calculated depth mark If the catheter meets obstruction DO NOT FORCE THE CATHETER Remove it and insert it through the other naris At this depth the balloon will be entering the thoracic cavity Attach the extension tubing 3 to the Y connector of the stylet 2 a syringe 4 and an isolated physiologic transducer to the 3 way stopcock 5 Catheter Placement Turn the 3 way stopcock 5 open to the syringe 4 and extension tube 3 Evacuate all the air from the balloon 1 by pulling back on the syringe plunger 4 and then allowing the plunger to return to a nonvacuum position Use of a glass syringe avoids creating a vacuum in the balloon catheter Turn the 3 way stopcock 5 off to the extension tube 3 remove the syringe 4 and fill the syringe 4 with 1 cc of air Attach the syringe 4 to the 3 way stopcock 5 open the 3 way stopcock 5 from the syringe 4 to the extension tube 3 Introduce 1 cc of air into the balloon 1 The balloon 1 will now be semi inflated An incorrect amount of air in the balloon will adversely affect pressure wave performance see Trouble Shooting Guide below After 1 ml of air is injected turn the stopcock 5 off to the syringe 4 and open from the extension tube 3 to the transducer to read pressure from the catheter If no or a damped p
23. between measurements so the measurement gas mixture can completely clear out from the patient s lung ky zem 7 Doctor Dr Semmelweis Ign c SE A z 2007 08 02 12 10 10 T V Setup Help ay Patients Fi Patients ms Capacity m John 75kg 178cm BTPS 27 C 999 hPa 40 4 m Spirometry 0 00 0 00 emanate Loe a E Setup Us EN Parameters Instructions 1 Audiometry Li ED S 9 v g i sina n PARAM REF M 01 RSD s Print A 3 IVC 5 48 6 78 124 Ei 8 IRV 3 20 ES Ext JEn ERV 2 68 NEM MEER set 1 TV 0 80 i TLC 7 44 8 75 123 rede EP S NE RV 1 67 1 98 118 ps E Nu En i r RV TLC 24 10 22 59 94 epe v m FRC 3 31 465 141 Ss SEITE Jj M dude FRC TLC 0 53 vid biu Tico 12 03 B 1237 uet discre uium Klco 2 14 8 Dlco 35 93 40 Tlco IB 16 35 Klco IB 1 87 v Teljes g rbe Megjelen t s nFly Anal zis Egy grafikon p D Ry Dlco IB 48 84 V Shutter Se Legjobb sszes T rl s BHt dezei eee T fogs CH4 0 2265 1 0587 co 0 1595 1 0370 C02 4 0715 7 WUV 4 8625 SOODE Is Piston Lung Function Test 101 Measurement modes Preparation Diffusion capacity measurement is a complex process requiring considerable cooperation from the patient Seat the patient Set chair height Set measurement head height Place the nasal clip so the patient can on
24. character permits a numeric character or a plus or minus sign in this position but doesn t require it ee The character is used to separate hours minutes and seconds in times If the character that separates hours minutes and seconds is different in the regional settings of the Control Panel utility on your computer system that character is used instead The character is used to separate months days and years in dates If the character that separates months days and years is different in the regional settings of the Control Panel utility on your computer system that character is used instead Piston Lung Function Test 172
25. correctly the patient circuit according to the section PDD 301 p Dose controlled drug nebulizer installation page 15 Thoracic gas volume measurement Resistance and TGV loops appear as vertical lines Cabin pressure measurement problem Check that the cabin door is properly closed The device must be recalibrated and leakage must be checked Most of the resistance loops are good but some are distorted Some sort of pneumatic interference happened during the measurement for example a window or door was opened If this is a regular occurrence find a more suitable place for the cabin The shutter does not open at the end of TGV measurement but loop curve is made The patient is not trying to breath properly the inhalation and exhalation attempt is not enough The shutter only opens after a number of acceptable complete cycles Perform a new measurement after properly informing the patient During TGV measurement the loop curve is completely horizontal Mouth pressure is not measured Check the shutter valve disc status and measurement head assembly must be checked Flow sensor temperature is not appropriate Heating is not operating properly Check the HEATING connection and cable The metronome does not emit a light signal or the shutter does not close Faulty connection Check the SHUTTER connection and cable After plethysmograph measurement
26. is technically correct A The measurement is technically incorrect The second icon indicates the given measurement s status Visible curve ni Ww The measurement appears on the graph with a solid line The system can store and print the measurement Questionable curve Dp The measurement appears on the graph with a dashed line a The system can store and print the measurement However they are easily distinguishable on the graph for the user Turned off curve X The system does not store or print this measurement Unlike when deleted the curves can be displayed again at anytime Changing status e Select the measurement and the required curve will be dashed e Clicking on the selected line again will rotate the curve status Selecting the best measurement Press the Best button to have the program automatically display the three best measurements and turn off the rest Press the All button to display all performed measurements Click the Report button to select just one from a couple of measurements Only the selected curve will be visible all the others will be switched off Piston Lung Function Test 77 Measurements Delete measurement It is possible to delete measurements not already stored e Select the measurement and the required curve will be dashed e Press the Delete button Enter comment A separate comment may be entered for all measurement modes All comments are stored separately
27. quiet breathing Piston Lung Function Test 113 Measurement modes Provocation test Measurement goal The goal of the measurement is performing a pharmaco dynamic test determining effect of inhaled agent on the lung function parameters of the patient ical 3 5zeRo Orvos Dr Semmelweis Ignac OB A v 2007 19 15 11 08 12 Paciensek Beallitasok S g 3 mm Provok ci s teszt Kov cs J nos 50kg 170cm BTPS 30C 1004 hPa 35 unm MM U Param terek EA M r si Instrukci k 2 PRE POST A Figyelmeztet sek ET Be ll t sok IVC 3 66 1 00 M r si m d 1 Param ter 2 Param ter 3 Param ter aX Kalibr ci FEv 9 5 8 87 100 n B 7 B n E N FVC apone zone 10 15 Provok l anyag mg EE ive tp 10 15 11 08 Alap m r s 4 41 100 3 66 100 8 87 100 ne WV 10 15 11 26 Acetylcholine 0 010 4 09 100 3 53 100 7 58 100 10 15 11 24 Acetylcholine 0 030 3 97 97 3 22 91 7 45 98 Rhino 10 15 11 24 Acetylcholine 0 060 3 72 91 3 16 89 6 68 88 TOV 10 15 11 25 Acetylcholine 0 120 3 46 85 2 66 75 5 70 75 CNN 10 15 11 24 Acetylcholine 0 250 3 41 84 2 50 71 4 60 61 10 15 11 23 Acetylcholine 0 500 3 09 76 2 48 70 4 58 60 xS Diff zi 10 15 11 22 Acetylcholine 1 000 3 06 75 2 39 68 4 47 59 no UTE 10 15 11 26 Acetylcholine 2 500 2 56 63 2 18 62 4 25 56 10 15 11 23 Acetylcholine 5 000 2 07 51 2 00 57 4 05 53 9 n 10 15 11 23 Acetylcholine 10 000 2
28. rameter MIS FEV 0 5 3 04 3 21 0 16 FEV 1 0 441100123 4 49 0 26 PRE POST report compilation e Select the PRE POST tab on the measurement window information panel e Select the two measurements to compare from the measurement selection list e You can also use the Quick keys to select the measurement use the mouse to select the desired Piston Lung Function Test 122 PRE POST measurement either from the summary table or directly on the graph e Selecting the two curves automatically refreshes the parameter table Printing Printing is similar to normal report printing e Select the PRE POST option in the report edit window e Select the parts of the report you would like to print During printing the graphs are displayed similar to the screen e Complete curve or only the representative curve section e One or more graphs Piston Lung Function Test 123 Technical data Warranty TECHNICAL DATA The device complies with the effective Technical Specifications The manufacturer guarantees the product according to the terms of the Installation Delivery protocol The warranty does not cover post delivery careless shipping unprofessional storage violent damaging abnormal operation unprofessional operation inefficient protection against external effects natural disasters or not following the contents of the User Manual Check package condition after delivery If packaging is damaged notify th
29. s 2 kV line s to earth 5 Ur gt 95 96 dip in U for 0 5 cycle 40 Ur 60 96 dip in U for 5 cycles 70 Ur 30 96 dip in U1 for 25 cycles 5 Uy gt 95 dip in Ur for5s 6 kV contact 8 kV air t2kV for power supply lines 1kV for input output lines 1 kV line s to line s 2 kV line s to earth 5 Ur gt 95 dip in Ux for 0 5 cycle 40 Ur 60 dip in U7 for 5 cycles 70 Ur 30 dip in U7 for 25 cycles Not applicable floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the PDD 301 p drug nebuliser requires continued operation during power mains interruptions it is recommended that the PDD 301 p drug nebuliser be powered from an uninterruptible power supply or a battery Power frequency 50 60 Hz magnetic field IEC 61000 4 8 Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE Uris the a c mains voltage prior to application of the test level Piston Lung Function Test 141 EMC Guidance and manufacturer s declaration Guidanc
30. shutter After shutter opening let the patient rest then optionally instruct him her to perform a complete IVC manoeuvre a complete expiration followed by a complete inspiration Push the Done button to stop the measurement Push the Discard button to delete the measurement Piston Lung Function Test 93 Measurement modes MS POCO 4 CDI CD 4 CO CO 44 Marker Correct TGV measurement Phases quiet breathing quiet breathing during Resistance loop recording shutter closing during TGV loop recording complete IVC manoeuvre return to normal breathing Selecting resistance loop Several 5 by default Resistance loops are recorded during the measurement From these the system automatically selects the loop closest to the average If you would like to select the Resistance loop into the report manually follow these steps e Select the measurement to be modified in the measurement summary table e Click with the mouse on the spirogram the marker jumps to the next cycle e The system automatically recalculates the parameters Piston Lung Function Test 94 Measurement modes Diffusion capacity test The system provides two alternative methods for measuring diffusion capacity e Single Breath Breath holding method The Breath holding method is the standard way for diffusion capacity measurement The patient has to make a deep inspiration from the gas mixture a
31. slowly by the patient after a total inspiration The following graphs are displayed during measurement e Volume time curve e CO ppm time Plethysmograph measurement P Complex lung function test to measure the mechanical parameters of the respiratory system Details may be found in the Measurement modes page 82 section In this operating mode the device measures the following parameters TLC Total Lung Capacity Total lung capacity TGV Thoracic Gas Volume Thoracic gas volume RV Residual Volume Residual volume RV TLC Residual Volume Total Lung Capacity The ratio of residual volume and total lung capacity Piston Lung Function Test 38 The program s main functions Raw Resistance of Airways Airway resistance Rin Resistance of Airways at Inspiration Airway resistance during inhalation Rex Resistance of Airways at Expiration Airway resistance during exhalation Req Equivalent Resistance Equivalent airway resistance sRaw Specific Resistance of Airways Specific airway resistance sRin Specific Resistance of Airways at Inspiration Specific airway resistance during inhalation sRex Specific Resistance of Airways at Expiration Specific airway resistance during exhalation Gaw Conductance of Airways Airway conductance Gin Conductance of Airways at Inspiration Airway conductance during inhalation Gex Conductance of Airways at Expiration Airway conductance during exhalation sGaw Specific Conductance of Airways Specific airway
32. the curve disappears and there are no measurement results The measurement stopped because the cabin door opened during measurement The measurement must be stopped with the Done button before opening the door Piston Lung Function Test 34 Troubleshooting Diffusion capacity test Problem Diagnosis Solution The patient cannot inhale gas mixture The gas supply system is faulty The following must be checked e Gas cylinder main valve is open e There is enough pressure in the gas cylinder e The secondary pressure is set to 6 bar Software Cannot find a patient Too many search criteria Enter less search criteria The patient s data cannot be loaded with the Load all button The patient probably has more than 8 measurements At most 8 measurements must be selected The patient s data cannot be loaded with the Selected button Not a single measurement has been selected If there is only one measurement in the list use the Load all button When making PRE POSTreport the program only prints previous data loaded from the database The new measurement has not been stored The measurement must be stored with the Store button before printing Piston Lung Function Test 35 The program s main functions THE PROGRAM S MAIN FUNCTIONS Available examinations Parallel measurements The
33. version More information can be found in the chapter Printing on the 78 page Export procedure Prior to printing and exporting results of measurements have to be stored in order to provide reliable traceability Click on the Print button at the main menu Select graphs tables and text fields to be exported Select the language of the report Select the type of the report PRE POST Piston Lung Function Test 80 Measurements e For previewing the report click on any button at the Print preview section e After setting click on the Store button Exported graphs are fully identical to the graphs shown on the screen e Full curve or only the important part e One or more graphs Interface to information systems Interface to frame systems Our system provides communication according to the more commonly used protocols e Health Level Seven HL7 e Ger te Daten Trager GDT These protocols provide exchange of the patient data and measured results between the lung diagnostics equipment and the frame systems These protocols are predefined by the System administrator consequently can not be modified by the user Receiving the request for tests Click on the LINK button in the main menu and open the Import Export window According to your frame system type click one of the HL7 or GDT buttons in the Import section in order to receive a Request for tests If a Request for test is available the system automat
34. year NORM SEX Age Equation 95 C I FVC 20 0 92A 08382H 3 469 1 64 150 0 022A 0 094H 1 774699A 1 26 25 0 078A 0 127H 5 5080169A 2 35 150 0 029A 0 165H 5 459296A 1 71 FEVO0 5 20 0 061A 0 048H 1 738 1 03 150 0 014A 0 048H 0 406 0 85 25 0 043A 0 076H 3 054 1 43 150 0 017A 0 094H 2 746 1 13 FEVO 5 FVC 150 Divide Predicteds FEV1 20 0 85A 0 06852H 2 703 1 39 150 0 021A 0 069H 0 794 1 12 25 0 045A 0 117H 4 808 1 95 150 027A 132H 4 203 1 51 FEV1 FVC 150 0 00109A 0 00282H 1 0738 x100 150 4 0 0014A 0 00221H 1 0364 x100 6 10 0 0220M 0 8119 11 19 0 0279M 2 8007 0 1275A 20 69 0 0300M 0 4057 0 0309A gt 70 6 3706 0 0615A 6 11 0 0338M 2 3197 12 24 0 0539M 6 1990 0 0749A 2 25 0 0579M 4 5175 0 0363A FEF 25 75 FEF 25 20 0 144A 0 112H 3 365 150 0 025A 0 109H 0 132 25 0 147A 0 1778H 7 054 150 0 035A 0 223H 5 628 FEF 50 6 10 0 7362 0 1846A 1 17 11 19 0 0238M 2 3040 0 1111A 1 76 20 69 0 0321M 0 4371 0 0240A 1 81 gt 70 0 0118M 6 2402 0 0755A 1 34 6 11 0 0378M 2 5454 1 30 12 24 0 0543M 6 3851 0 1150A 247 2 25 0 0634M 5 5409 0 0366A 2 67 FEF 75 6 10 0 0109M 0 1657 0 836 11 19 0 0243M 4 4009 0 2923A 1 25 20 69 0 0174M 0 1822 0 0254A 1 35 gt 70 1 8894 0 0172A 0 41 6 11 0 0171M 1 0149 0 89 12 24 0 0397M 4 2421 0 0057A 1 46 2 25 0 0310M 2 48
35. 0 C 60 C Relative humidity 5 entere teens 10 100 Atmospheric pressure cceseeceeseeceeeeeeeees 500 1060 mbar Storage conditions Air temperatures iiis etatis tete ns 0 C 50 C Relative humidity aat eto sette pre e EID EAE 10 8596 Atmospheric pressure 4 adicit nine 500 1060 mbar Operating conditions AIP temperature iein onee HL aE R 10 C 40 C Relative humidity odo iota be ares Gases 30 75 Atmospheric pressure ese eeeeeeeeeeeeeneeeeneeees 700 1060 mbar Informing values Expected lifetime CVI CSS aed oue uere x deae Lr Su ne Matic 8 years Measurement head lifetime 2 rrt retenue 2 years Forced inhalation and exhalation Measurement duration eese eene nnne 60 s Volume measurement limit eeeeeeeeeeeeeeneenee 151 Vital capacity measurement Measurement duration sees eere enne 60 s Volume measurement limit eeeeceeeerereneer nn 151 Maximal voluntary ventilation Measurement duration eese eheu 60 s Volume measurement limit eeeeee 250 l min Plethysmograph measurement Measurement duration ssssseseseseseseseseserererererererererererererereee 60 s Volume measurement limit ssseeeeeeee 15 l min Pressure measurement FdDge sete oreet ie etii epee HT 10 kPa Flow meter Cnr M 15 I s Resistance at 10 l s
36. 0 0140 0 0100 0 1164 0 0100 0 1492 0 00810 0 05680 0 00650 0 00500 0 00390 0 00760 0 01670 0 01730 0 30450 0 01390 0 00690 Tobacco Pack g nap years 0 1694 0 0008 0 0042 0 0041 1 0101 0 06020 0 00180 0 00770 0 09990 0 70400 Age Pack years 0 000170 0 000023 Constants 0 130 136 400 8 165 25 750 4 205 2 079 4 819 3 970 4 073 4 088 0 793 2 550 6 544 3 640 4 320 6 103 111 600 4 329 4 67000 109 40000 12 78000 19 26000 8 44000 3 90000 5 47000 0 19000 1 71000 3 79000 0 27000 102 50000 5 80000 6 59000 3 76000 13 73000 24 44000 8 56000 RSD 0 400 6 870 0 510 6 640 0 430 0 400 0 410 0 490 1 090 1 370 0 230 13 800 1 260 0 440 6 580 0 580 20 100 0 430 0 46000 6 04000 0 70000 6 01000 0 61000 0 44000 0 43000 0 51000 1 15000 1 56000 0 15000 18 50000 1 29000 0 46000 5 16000 0 79000 22 20000 0 62000 Piston Lung Function Test 171 Appendix II APPENDIX Il Format of the patient identification field The format of the patient identification filed can be any free text or some predefined format according to a special mask If this mask is defined the ID field is compulsory to fill during adding a new patient Otherwise the field can be left empty If a character appears in the mask optional characters are represented in the text as leading blanks If a characte
37. 0 seconds Check that liquid did not get into the flow sensor or the twin tube leading to it The measured values deviate from expected to a considerable extent The device has to be recalibrated Environmental data must be checked If the situation does not get better even after recalibration clean the pneumatic twin tubes and check the flow sensor according to Flow meter maintenance page 30 section Rhinomanometer The resistance curves are too steep The pressure meter s or the nasal plug s pneumatic tube is not connected appropriately it maybe punctured Check the pressure tubes The nasal plug the filter or the pressure release tube is clogged The resistance curves are too flat The device measures the drive pressure to be too high Check the pressure tubes The nasal plug the filter or the pressure release tube is clogged Piston Lung Function Test 33 Troubleshooting Medication nebulizer Problem Diagnosis Solution Medication vaporization does not start with inhalation The device measures the mouth pressure incorrectly The mouth pressure release tube is either incorrectly connected or clogged The vaporization threshold pressure value is set too high The patient cannot inhale or exhale or only with difficulty One of the two check valves built into the patient circuit inhalation and exhalation side is inverted Assemble
38. 001 28202723002 HD 2111265 01 C 2192133 E 01 MAIN ACCESSORIES MPA 30 Mouth piece BUDAPEST 11 MAY 2007 Korn l NAGY Mr 5e es 05 5 Quality Assurance Manager Piston Lung Function Test 158 EC Declaration of Conformity PISTON Ltd 1121 Budapest Pihen u 1 C pavilon HUNGARY Tel 36 1 275 0033 Fax 36 1 275 0034 http www pistonmedical com Email info pistonmedical com EC DECLARATION OF CONFORMITY MANUFACTURER Piston Ltd Hungary H 1121 Budapest Pihen u 1 c PRODUCT Mouthpiece for spirometry MODEL NUMBER MPA 30 CLASSIFICATION Class lla Council Directive 93 42 EEC of MDD Annex V Article 3 DECLARATION We herewith declare that the above mentioned products meet the provision of the Council Directive 93 42 EEC for medical devices All supporting documentation is retained under the premises of the manufacturer STANDARDS APPLIED EN 60601 1 EN 60601 1 2 EN 30993 1 EN 980 EN 1441 NOTIFIED BODY T V Rheinland Product Safety GmbH Germany D 51105 K ln Am Garuen Stein EC CERTIFICATES ISO 13485 2003 Registration Nr Report Nr CE 0197 Registration Nr Report Nr SX 600174060001 28202723002 HD 2111265 01 C 2192133 E 01 MAIN ACCESSORIES PBF 30SU Bacterial and viral vilter BUDAPEST 11 MAY 2007 Korn l NAGY Mr 5e es 05 5 Quality Assurance Manager Piston Lung Function Test 159 E
39. 0601 1 EN 60601 1 2 EN 30993 1 EN 980 EN 1441 NoriFIED BODY T V Rheinland Product Safety GmbH Germany D 51105 K ln Am Grauen Stein EC CERTIFICATES ISO 13485 2003 Registration Nr Report Nr CE 0197 Registration Nr Report Nr SX 600174060001 28202723002 HD 2111265 01 C 2192133 E 01 BUDAPEST 12 JUNE 2007 A inn Op EN Korn l NAGY Mr 5e ess Quality Assurance Manage Piston Lung Function Test 157 EC Declaration of Conformity PISTON Ltd 1121 Budapest Pihen u 1 C pavilon HUNGARY Tel 36 1 275 0033 Fax 36 1 275 0034 http www pistonmedical com Email info pistonmedical com EC DECLARATION OF CONFORMITY MANUFACTURER Piston Ltd Hungary H 1121 Budapest Pihen u 1 c PRODUCT Bacterial and viral filter for spirometry MODEL NUMBER PBF 30SU CLASSIFICATION Class lla Council Directive 93 42 EEC of MDD Annex V Article 3 DECLARATION We herewith declare that the above mentioned products meet the provision of the Council Directive 93 42 EEC for medical devices All supporting documentation is retained under the premises of the manufacturer STANDARDS APPLIED EN 60601 1 EN 60601 1 2 EN 30993 1 EN 980 EN 1441 NOTIFIED BODY T V Rheinland Product Safety GmbH Germany D 51105 K ln Am Garuen Stein EC CERTIFICATES ISO 13485 2003 Registration Nr Report Nr CE 0197 Registration Nr Report Nr SX 600174060
40. 1 x Vtg 0 227 0 041 x Vtg 7 143 0 49 Pred Raw 3 57 0 73 Pred Raw 7 143 0 49 Pred Raw 3 45 0 73 Pred Raw Piston Lung Function Test 168 Appendix l Austrian National H height metre A age year W weight kg Fi H NYW Male FVC I 11 606 8 172H 0 0339A H 1 2869In A 0 628 FEV 1 0 I 8 125 6 212H 0 03A H 0 977In A 0 533 PEF V s 1 798 2 31 1In H 0 0159A 0 000248A2 0 269 MEF 75 l s 1 581 1 854In H 0 0213A 0 000283A2 0 300 VMEF 50 l s 1 490 1 290In H 0 0125A 0 000218A2 0 314 VMEF 25 l s 1 31440 898In H 0 00834 0 000026A2 0 231 FEV 1 0 FVC 101 99 1 191H2 3 962In A 5 450 Female FVC I 10 815 6 640H 0 0408A H 1 7293In A 0 450 FEV 1 0 I 6 995 5 174H 0 0314A H 1 0251In A 0 384 PEF V s 1 832 1 838In H 0 0078A 0 000172A2 0 236 MEF 75 l s 1 779 1 4211n H 0 0096A 0 000179A2 0 247 VMEF 50 l s 1 561 1 177In H 0 0045A 0 000140A2 0 268 VMEF 25 l s 1 372 0 938In H 0 0152A 0 000036A2 0 212 FEV 1 0 FVC 118 993 3 032H2 6 9053In A 5 318 Boys Ln FVC I 1 142 1 259H 0 004070AVW 0 111 Ln FEV 1 0 I 1 178 1 221H 0 003841AVW 0 112 Ln PEF l s 0 214 0 921H 0 0467A 0 0020W 0 150 Ln MEF 75 l s 0 077 0 770H 0 0373A 0 0025W 0 177 Ln MEF 50 l s 0 522 0 843H 0 0300A 0 0035W 0 221 Ln MEF 25 l s 1 576 1 166H 0 0219A 0 0021W 0 291 FEV 1 0 FVC 96 101 99 1 191H2 3 962In A 5 450 Girls Ln FVC I 3 84244 1632NH 0 1341NA 1 614Fi 0 112 Ln FEV 1 0 I
41. 24 0 0230A 1 45 PEP 20 0 257A 0 2244H 3 926 Piston Lung Function Test 165 Appendix l F 150 0 025A 0 1244H 0 735 M 25 0 266A 0 198H 8 06 M 150 0 035A 0 2387H 5 993 FIVC F 20 0 092A 0 8382H 3 469 1 64 F 150 0 022A 0 094H 1 774 1 26 M 25 0 078A 0 127H 5 508 2 35 M 150 0 029A 0 165H 5 459 1 71 MVV A 18 3 241H 99 51 F 150 0 77A 138 32 80 M 150 1 26A 3 39H 21 4 55 76 VC F 20 0 092A 0 08382H 3 469 1 64 F 150 0 022A 0 094H 1 774 1 26 M 25 0 078A 0 127H 5 508 2 35 M 150 0 029A 0 165H 5 549 1 71 TLC F 18 0 1493M 5 101 F 150 0 008A 0 201H 7 49 0 767 M 18 0 1495H 5 034 M 150 0 015A 0 239H 9 17 0 999 RV A 18 0 029H 0 9192 F 150 0 009A 0 0813H 3 9 0 705 M 150 0 017A 0 0686H 3 45 0 790 RV TLC A 18 Divide Predicteds F 150 0 00265A 0 217 x 100 11 73 M 150 0 00343A 0 167 x 100 12 02 Raw F lt 17 7 1431 Vtg 0 49 F gt 18 3 45 Vtg 0 27 M lt 17 7 143 Vtg 0 49 M gt 18 3 57 Vtg 0 73 Gaw A lt 18 0 24 x Vig F 7 47 0 227 0 041 x Vtg M 7 47 0 227 0 041 x Vtg sRaw F lt 17 7 143 0 49 Pred Raw F 2218 3 45 0 27 Pred Raw M 217 7 143 0 49 Pred Raw M 2 18 3 57 0 73 Pred Raw Piston Lung Function Test 166 Appendix l Crapo Hsu April 1984 F female M male H height centimetre A age year NORM SEX Age Equation 95 C I FVC M 15 91 0 0600M 0 0214A 4 650 1 00 M 15 3 58 x 10 4 x M 3 18 F 15
42. 3756 12 24 0 0590M 6 8865 0 0739A 2 25 0 0844M 8 7818 0 0298A 20 0 061A 0 048H 1 738 1 03 150 0 014A 0 048H 0 406 0 85 25 0 043A 0 076H 3 054 1 43 150 0 017A 0 094H 2 746 1 13 150 Divide Predicteds 6 10 0 0336M 2 7578 11 19 0 0351M 3 7622 0 0694A 20 69 0 0332M 1 8210 0 0190A gt 70 0 0143M 2 6539 0 0397A 6 11 0 0348M 2 8142 12 24 0 0519M 6 1181 0 0636A 2 25 0 0665M 6 5147 0 0292A 150 0 00109A 0 00282H 1 0738 x100 150 0 0014A 0 00221H 1 0364 x100 6 10 0 0220M 0 8119 11 19 0 0279M 2 8007 0 1275A 20 69 0 0300M 0 4057 0 0309A 2 70 6 3706 0 0615A 6 11 0 0338M 2 3197 12 24 0 0539M 6 1990 0 0749A 2 25 0 0579M 4 5175 0 0363A FEVO 5 FEVO 5 FVC FEV1 FEV1 FVC FEF 25 75 FEF 25 20 0 144A 0 112H 3 365 150 0 025A 0 109H 0 132 25 0 147A 0 1778H 7 054 150 0 035A 0 223H 5 618 FEF 50 6 10 0 7362 0 1846A 1 17 11 19 0 0238M 2 3040 0 1111A 1 76 20 69 0 0321M 0 4371 0 0240A 1 81 gt 70 0 0118M 6 2402 0 0755A 1 34 6 11 0 0378M 2 5454 1 30 12 24 0 0543M 6 3851 0 1150A 2 47 gt 25 0 0634M 5 5409 0 0366A 2 67 FEF 75 6 10 0 0109M 0 1657 0 83 11 19 0 0243M 4 4009 0 1775A 1 25 20 69 0 0174M 0 1822 0 0254A 1 35 Piston Lung Function Test 163 Appendix l PEF FIVC MVV VC TLC RV RV TLC Raw Gaw sRaw DLC
43. 4 The number of recommended cycles is 10 Piston Lung Function Test 67 Calibration The first part of calibration should be done with the peak flow at about 1 0 l s red curves The second part of calibration should be done with the peak flow at about 5 0 I s green curves After the calibration process the system automatically calculates calibration factors for the different flow values The following values appear in the calibration result table Param name of the measured parameter Pred reference value Meas the measured value during calibration difference of measured value from the reference Possible error messages Calibration must contain at least 10 exhalations and inhalations Calibration was not performed properly e There were less calibration cycles than prescribed e The flow meter slipped out of the calibrating pump during calibration Asymmetry error In this case either calibration was performed incorrectly or an error occurred in the system e You did not pull out or push in the calibrating pump all the way Check pneumatic connections Check flow meter assembly Check that the twin tube is not broken or punctured Check that there is no liquid in the flow sensor or the twin tube Flowmeter error out of allowed range If during calibration the device measures the calibration volume with greater than 20 error there is a chance for hardware problems Piston Lung Function Te
44. 74060001 Report Nr 28202723002 CE 0197 Registration Nr HD 2111265 01 Report Nr C 2192133 E 01 MAIN ACCESSORIES PCS 3000 Calibration syringe PBF 30 Bacterial filter MPA 30 Mouth piece BUDAPEST 11 May 2007 ML aC DESEE Mr ae Nor Quality Assurance Manager Piston Lung Function Test 150 EC Declaration of Conformity PISTON Ltd Tel 36 1 275 0033 1121 Budapest Fax 36 1 275 0034 Pihen u 1 C pavilon http www pistonmedical com HUNGARY Email info pistonmedical com EC DECLARATION OF CONFORMITY MANUFACTURER Piston Ltd Hungary H 1121 Budapest Pihen u 1 c PRODUCT Dose controlled drug nebulizer IBM PC based MODEL NUMBER PDD 301 p CLASSIFICATION Class lla Council Directive 93 42 EEC of MDD Annex V Article 3 DECLARATION We herewith declare that the above mentioned products meet the provision of the Council Directive 93 42 EEC for medical devices All supporting documentation is retained under the premises of the manufacturer STANDARDS APPLIED EN 60601 1 EN 60601 1 2 EN 30993 1 EN 980 EN 1441 NOTIFIED BODY T V Rheinland Product Safety GmbH Germany D 51105 K ln Am Garuen Stein EC CERTIFICATES ISO 13485 2003 Registration Nr SX 600174060001 Report Nr 28202723002 CE 0197 Registration Nr HD 2111265 01 Report Nr C 2192133 E 01 MAIN ACCESSORIES PCS 3000 Calibration syringe PBF 30 Bacterial filter MPA 30 Mouth piece
45. 9 hPa 40 8 jagnose l l N Measure time 4 uz cc c memes Waning deer Ws s 1 WA wl Parameters Instructions r i Audiometry e O v s e a 1 PARAM REF M01 RSD Print a i Ei enn IVC 5 48 5 28 96 ee f I IRV 1 68 ES Exit 6 j i ERV 2 53 i ERAS fel Eh TV 1 05 POSEES EE a A TLC 7 14 6 72 94 S e EET RV 1 67 1 44 86 I Tf ROS SII i Pann ER T 5 aum RV TLC 24 10 21 46 89 NES Dk GE per m FRC 3 31 3 98 120 qu EAE S A SA N UONUT FRC TLC 0 59 ar eet i Tico 12 03 10 05 84 Ene Klco 2 44 1 72 80 8 i BHt 10 02 40 d WOY 1 48 7 Full graph Display 2 Dlco 35 93 30 02 84 OnFly Analysis Single graph p FACH4 0 228 V Shutter O Side by side Best Al j Delete FACO 0 121 Volume nmm Time _ E Practicing n mode ata Pes Se CH4 0 2282 co 0 1212 c02 4 5411 WOY 1 4811 40 50 60 lil Piston Lung Function Test 96 Measurement modes Preparation Diffusion capacity measurement is a complex process requiring considerable cooperation from the patient Seat the patient Set chair height Set measurement head height Place the nasal clip so the patient can only breath through the mouth Tell the patient the exact measurement process Prepare the patient for unexpected and unusual events such as gas mixture inhalation through the Demand valve and holding the breath Measurement process The following series of manoeuvres must be performed
46. 91 0 0491M 0 0216A 3 590 0 67 F 15 2 57 x 10 3 x M 2 78 FEV 0 5 M 15 91 0 0327M 0 0152A 1 914 0 70 F 15 91 0 0238M 0 0185A 0 809 0 50 FEV 1 0 M 15 91 0 0414M 0 02444 2 190 0 80 M 15 7 74 x 10 4 x M 3 00 F 15 91 0 0342M 0 0255A 1 578 0 56 F 15 3 79 x10 3x M 2 68 FEV1 FVC M 15 91 0 1300M 0 152A 110 49 8 28 F 15 91 0 2020M 0 252A 126 58 9 06 FEF 25 75 M 15 91 0 0204M 0 0380A 2 133 1 66 M 15 7 98 x 10 4 x M 246 E 15 91 0 0154M 0 0460A 2 683 1 36 F 15 3 79 x 10 3x M 2 16 PEF M 15 3 35 x 10 4 x M 2 79 F 15 2 58 x 10 3 x M 2 37 FIVC M 15 91 0 0600M 0 0214A 4 650 1 10 M 15 3 58 x 10 4 x M 3 18 F 15 91 0 0491M 0 0216A 3 590 0 60 F 15 2 57 x 10 3 x M 2 78 TLC M 15 91 0 0795 0 0032A 7 333 1 60 M 1511 0 1495H 5 034 F 15 91 0 0590M 4 537 1 00 F 15 0 1493H 5 101 RV A 15 0 029H 0 9192 M 15 91 0 0216M 0 0207A 2 840 0 76 F 15 91 0 0197M 0 0201A 2 421 0 77 RV TLC A 15 Divide Predicteds M 15 91 0 3090A 14 060 9 80 F 15 91 0 4160A 14 350 11 00 VC M 15 91 0 0600M 0 0214A 4 650 1 11 M 15 3 58 x 10 4 x M 3 18 F 15 91 0 0491M 0 0216A 3 590 0 67 F 15 2 57 x 10 3 x M 2 78 Raw M lt 17 7 143 Vtg 0 49 M gt 18 3 57 Vtg 0 73 F lt 17 7 143 Vtg 0 49 F gt 18 3 45 Vtg 0 27 Gaw A lt 18 0 24 x Vtg Piston Lung Function Test 167 Appendix l sRaw 7 17 7 17 lt 17 gt 18 lt 17 gt 18 0 227 0 04
47. A PRE POST Warnings ag Setup yr spiromety F 2 Parameters Y Instructions Audiometry Delo H Li r4 rl a a iani aei T f PARAM REF M 01 RSD C Print cu D QE DAN z a Lo s i TIS SUD SM MANUS NUNC STAT IVC 4 58 4 21 92 il A ES RD EE UMMK T EENM IRV 1 90 RR ERV 1 26 i A i TV 1 02 svc 2 45 ee ee EDEN MEE E 8 10 Full graph Disp 9 a ee Singe graph i Q O Side by side AM jJ Delete Volume Time EI BRE emn pe mn REP TRAC aeiee i VOLO peru HO TISAHAC E Yers ed TEMPORE HT T UNE T puteum e 8 H i 4 T I 2 AN Aro Db soc REX a a es SW fee RO Lir nt et SHE a cae om ame eee Ss E du Esc EE UR ml CI LLL LII Piston Lung Function Test 84 Measurement modes Measurement process Instruct the patient to perform the following manoeuvres e Put on the nasal clip so he she can only breath through the nose At least three quiet breaths As deep expiration as possible As deep inspiration as possible Optionally as deep expiration as possible to get the SVC Slow Vital Capacity parameter The patient has 60 second to perform the IVC manoeuvre Push the Done button to stop the measurement Push the Discard button to delete the measurement In N HMw O Cl 0 4 CO CO Correct ICV manoeuvre Phases Quiet breathing complete deep expiration complete deep inspiration return to normal breathing Piston Lung Function Test 85 Measurement modes Maximal v
48. BUDAPEST 11 May 2007 EAE Mr efe Quality Assurance Manag r lt Piston Lung Function Test 151 EC Declaration of Conformity PISTON Ltd H 1033 Budapest Sz l kert u 4 b HUNGARY Tel 36 1 275 0033 Fax 36 1 275 0034 http www pistonmedical com Email info pistonmedical com EC DECLARATION OF CONFORMITY MANUFACTURER PRODUCT MODEL NUMBER CLASSIFICATION DECLARATION Piston Ltd Hungary H 1033 Budapest Sz l kert u 4 b Breath carbon monoxide monitor PDD 301 sco and PDD 301 rco Class lla Council Directive 93 42 EEC of MDD Annex IX We herewith declare that the above mentioned products meet the provision of the Council Directive 93 42 EEC for medical devices All supporting documentation is retained under the premises of the manufacturer STANDARDS APPLIED EN 60601 1 2005 EN 60601 1 1 2001 EN 60601 1 2 2001 EN 60601 1 4 1996 EN 60601 1 6 2004 EN 980 2003 EN 1041 1998 ISO 14971 2000 NOTIFIED BODY EC CERTIFICATES T V Rheinland Product Safety GmbH Germany D 51105 K ln Am Grauen Stein MAIN ACCESSORIES ISO 13485 2003 Registration Nr SX 60009710 0001 Report Nr 02192133 004 CE 0197 Registration Nr HD 2111265 01 Report Nr C 2192133 E 01 PCS 3000 Calibration syringe PBF 30 Bacterial filter MPA 30 Mouth piece BUDAPEST 25 AUG 2008 PIs 10 Ti U US Udape s s 3 de ft s Mia Ne NE 052 41 Korn GY Mr Quality Assurance Manager Pis
49. C Declaration of Conformity PISTON Ltd 1121 Budapest Pihen u 1 C pavilon HUNGARY Tel 36 1 275 0033 Fax 36 1 275 0034 http www pistonmedical com Email info pistonmedical com EC DECLARATION OF CONFORMITY MANUFACTURER Piston Ltd Hungary H 1121 Budapest Pihen u 1 c PRODUCT Nasal probe for rhinomanometer MODEL NUMBER PNP 12 PNP 14 PNP 16 different sizes CLASSIFICATION Class lla Council Directive 93 42 EEC of MDD Annex V Article 3 DECLARATION We herewith declare that the above mentioned products meet the provision of the Council Directive 93 42 EEC for medical devices All supporting documentation is retained under the premises of the manufacturer STANDARDS APPLIED EN 60601 1 EN 60601 1 2 EN 30993 1 EN 980 EN 1441 NOTIFIED BoDY TUV Rheinland Product Safety GmbH Germany D 51105 K ln Am Garuen Stein EC CERTIFICATES ISO 13485 2003 Registration Nr Report Nr CE 0197 Registration Nr Report Nr SX 600174060001 28202723002 HD 2111265 01 C 2192133 E 01 MAIN ACCESSORIES Not specified BUDAPEST 11 MAY 2007 Korn l NAGY Mr 5e es 05 5 Quality Assurance Manager Piston Lung Function Test 160 Appendix l APPENDIX I List of reference value algorithms ECCS ERS Quanjer 1993 Knudson 1983 Cotton and Dust Standard Crapo Hsu Austrian National Sweden National Hedenstr m Malmberg 1985 Finnish N
50. Doctors Cabin volume 330 00 L E Rovinen Volume of sensor 175 mL C Resistance of sensor Audiometar Cabin calib volume 150 mL Ae Diffusion Enable Metronome Yes sil 2 oor Low breathing rate 40 fel1 mn 20 70 ANY Calibration Syringe ee High breathing rate 70 E 1 min 60 200 EEL AutoBTPS Yes v Rhinomanometer Efficiency of BTPS t E 0 100 Number of Resistance loops 5 E pes 2 10 Number of TGY loops 5 EI pes 2 10 Barometer Measured 999 mbar 399 ml mbar Resistance Calculation Matthys p i T Bacterial Filter used Yes v 4a Maintenance oa Notify me if calibration of this device is actual s amp S Prediction Calibration interval le fal hour v B Parameters USB Plethysmograph 2 disconnected S Institute data You can enter the following information at the Setup Options Institute setup menu item Institute name Site address Mailing address Phone number Fax number Web page E mail address This data appears in the header of the printed report Doctor s data The doctor s data can be entered at the Setup Options Doctors menu item New doctor Press the New Doctor button to enter data for a new doctor Complete the fields Piston Lung Function Test 54 Settings Make sure that two doctors cannot have the same identifier Press the Save button to store the entered data Modify data Select the doctor from the Doctor s name d
51. ER INTERFACE Icons Main window Open patient database Open comment opinion editor Open lung function test sub menus Open external ECG Software Health Level Seven HL7 and GDT import and export functions Open report editor printing Exit the program E Main window Lung function test Open calibration measurement window The checkmark indicates that all connected devices are calibrated Open calibration window The exclamation point indicates that one or more connected device needs to be calibrated Forced vital capacity FVC Inspiratory vital capacity IVC Maximal voluntary ventilation MV V Rhinomanometry xF CEA Piston Lung Function Test 46 User interface Thoracic gas volume and Resistance measurement Compliance measurement Diffusion capacity test Maximum inspiratory and expiratory pressure e Provocation test Qs Breath carbon monoxide monitoring Manual 5 e Patient database Clear patient quick search fields Enter new patient Modify patient data Store entered modified data Cancel changes Load all measurements from the selected meeting s Load selected measurements Health Level Seven HL7 import and export functions ABa y I akg Piston Lung Function Test 47 User interface Settings Set institute data Doctor records Devices settings connected to the PC Program operation related settings Display graphs and other p
52. IB L CHA concentration by IB on Left side Exhaled CH4 concentration at the left side of gas sampling window during Intra Breath measurement CHA IB R CHA concentration by IB on Right side Exhaled CH4 concentration at the right side of gas sampling window during Intra Breath measurement COIBL CO concentration by IB on Left side Exhaled CO concentration at the left side of gas sampling window during Intra Breath measurement CO IBR CO concentration by IB on Right side Exhaled CO concentration at the right side of gas sampling window during Intra Breath measurement The following graphs are displayedduring measurement e Volume time curve with CH4 CO CO gas concentration functions e Flow volume loop Maximal respiratory pressure Pp The measurement of the respiration muscles maximum strength Detailed information may be found in the Measurement modes page 82 section In this operating mode the device measures the following parameters PEmax Maximal expiratory pressure Maximum expiratory pressure PImax Maximal inspiratory pressure Maximum inspiratory pressure Piston Lung Function Test 41 The program s main functions The following graphs are displayed during measurement e Volume time curve Compliance PD The measurement of compliance of the lungs Detailed information may be found in the Measurement modes 82 page section In this operating mode the device measures the following paramet
53. Instit tedata seo Na oditaut eats te EE LAE RE 54 IDOCUOP Saldo sean dte s e Deae neu tates esas eevee access 54 Language selection udo cope des o otf tedtesiiie e ote asfeset testa 55 Patient identification formats i405 iu cihede dedeodaaattlesiecesead Gaesecsdadeesdieecndeicadse 55 Graph dn PIC m 35 Piston Lung Function Test 1 Curve magnificat ODE e eed delete bod een uidet Leu n suu tonus 56 Reference values sentence teer itte reete obese Ee EI e OREL S 56 Displayed parameters snai rede estoit poa ho ee ee 56 IDDeViGes Ren RnR READE oL me To te LUE ec lee A teda 57 User interface OVEEVIW inisee treat duit Lee itu oe E NTE ESS 62 DataInput forni isetare BA cect te eae BAe eua eae sient 63 Patient s persOlidl dalqa s e A REE o E Bs 64 Finding a patient in the database recie appen des 65 Viewing prevTOUS dDeaSuretebls iecit oe echter aetati ve Ead 65 Comment field for patients aseo piget eere od o dp uas 66 C ANU TAU OI Pee USES LY Flow meter calibration ss sa ek eee le fie ee Sell eee tei ates 67 Plethysmograph calibration uie eee telo ordre ente tired 69 Diffusion capacity test calibration iacu icr ooa eo e deque 70 Checking calibration Tesulfs 5 54 6 o cea Gu re eae de Da e e ae becas 70 Viewing previous calibration data seen 70 MIC rails parcet ESI General measurement process daily routine eene 71 Patient SeleCctiol rnare a en
54. O 20 150 25 150 6 10 11 19 20 69 gt 70 6 11 12 24 gt 25 18 150 150 6 10 11 19 20 69 gt 70 12 24 gt 25 18 150 25 250 18 150 150 18 150 150 17 18 17 18 18 7 17 7 17 17 18 17 18 17 150 50 0 157A 0 1244H 3 916 0 025A 0 1244H 0 735 0 166A 0 198H 8 06 0 035A 0 2387H 5 993 0 0430M 3 7486 0 0416M 4 4470 0 0699A 0 0444M 3 1947 0 0169A 0 0313M 0 1889 0 0296A 0 0409M 3 3756 0 0590M 6 8865 0 0739A 0 0844M 8 7818 0 0298A 3 241H 99 51 0 77A 138 32 80 1 26A 3 39H 21 4 55 76 0 0430M 3 7486 0 0416M 4 4470 0 0699A 0 0444M 3 1947 0 0169A 0 0409M 3 3756 0 0590M 6 8865 0 0739A 0 0844M 8 7818 0 0298A 0 2493M 5 101 0 008A 0 201H 7 49 0 767 0 1495H 5 034 0 015A 0 239H 9 17 0 999 0 029H 0 9292 0 009A 0 0813H 3 9 0 705 0 017A 0 0686H 3 45 0 790 Divide Predicteds 0 00265A 0 217 x 100 11 73 0 00343A 0 167 x 100 12 02 7 143 Vtg 0 49 3 45 Vtg 0 27 7 143 Vtg 0 49 3 57 Vtg 0 73 0 24 x Vig 0 227 0 041 x Vtg 0 227 0 041 x Vtg 7 143 0 49 Pred Raw 3 45 0 27 Pred Raw 7 143 0 49 Pred Raw 3 57 0 73 Pred Raw Antilog10 0 01666H 0 308 0 117A 15 5BSA 0 5 6 0 0 238A 15 5BSA 6 8 8 2 Piston Lung Function Test 164 Appendix l Cotton and Dust Standard January 1984 F female M male H height centimetre A age
55. PDT 111 d CLASSIFICATION Class lla Council Directive 93 42 EEC of MDD Annex V Article 3 DECLARATION We herewith declare that the above mentioned products meet the provision of the Council Directive 93 42 EEC for medical devices All supporting documentation is retained under the premises of the manufacturer STANDARDS APPLIED EN 60601 1 EN 60601 1 2 EN 30993 1 EN 980 EN 1441 NoriFIED BODY T V Rheinland Product Safety GmbH Germany D 51105 K ln Am Garuen Stein EC CERTIFICATES MAIN ACCESSORIES ISO 13485 2003 Registration Nr SX 600174060001 Report Nr 28202723002 CE 0197 Safety test Report Nr 28203472001 ENC test Report Nr 28203473001 PCS 3000 Calibration syringe PBF 30 Bacterial filter MPA 30 Mouth piece BUDAPEST 11 MAY 2007 Korn l NAGY Mr 2 Quality Assurance Manes Piston Lung Function Test 155 EC Declaration of Conformity PISTON Ltd 1121 Budapest Pihen u 1 C pavilon HUNGARY Tel 36 1 275 0033 Fax 36 1 275 0034 http www pistonmedical com Email info pistonmedical com EC DECLARATION OF CONFORMITY MANUFACTURER Piston Ltd Hungary H 1121 Budapest Pihen u 1 c PRODUCT Whole body plethysmograph and Diffusion capacity test MODEL NUMBER PDT 111 pd CLASSIFICATION Class lla Council Directive 93 42 EEC of MDD Annex V Article 3 DECLARATION We herewith declare that the above mentioned pro
56. PEF RV RV TLC TLC TLCO IVC Male FEV1 FEV1 IVC FRC FRC TLC FVC Ln Gaw V Ln Raw MEF25 MEF50 MEF75 MTT MVV PEF RV RV TLC TLC TLCO IVC The reference value equals to the sum of the parameters in the header multiplied with the value in the given row Smoke Years Duration of smoking years Pack years Smoke Years gram Tobacco day 20 Age 0 000118 0 000768 0 000132 0 001302 0 001206 0 01206 0 000145 0 00041 0 00071 0 00022 0 00064 0 00051 0 00034 0 00069 Age 0 0281 0 2371 0 0153 0 2504 0 0143 0 0019 0 0007 0 1013 0 0509 0 0739 0 0051 0 7806 0 0647 0 0289 0 5094 0 0104 0 0119 0 01450 0 22510 0 01950 0 17610 0 04670 0 00750 0 00290 0 05130 0 02450 0 01930 0 00610 0 76290 0 01690 0 02680 0 32480 0 01170 1 01030 0 04710 Height cm 0 0258 0 2809 0 0752 0 6059 0 0545 0 0068 0 0098 0 8124 0 0231 0 0700 0 0552 0 05090 0 12860 0 11070 0 60170 0 07440 0 01570 0 00980 0 01930 0 03750 0 06780 0 00440 1 55240 0 08850 0 04980 0 16850 0 12340 1 31490 0 07520 Weight kg 0 0294 0 4536 0 0054 0 0337 0 0339 0 0049 0 0195 0 7517 0 05090 0 12860 0 04840 0 54150 0 07440 0 01570 0 00980 0 01930 0 03750 0 06780 0 00440 1 55240 0 08850 0 01810 0 16710 0 01720 1 31490 0 07520 Smoke years 0 0052 0 0094 0 0086 0 0219 0 0121 0 1368
57. The patient must breath evenly after the measurement started The Gas button is enabled after the third relaxed breath Instruct the patient to exhale relaxed deep completely Press the Gas button when the patient started the complete deep exhalation During the next inhalation the patient inhales the measurement gas mixture and must be instructed to inhale completely deeply Breath holding begins after inhalation the remaining time appears on the screen Warn the patient to hold the breath do not press it onto the shutter and do not try to inhale The metronome indicates the end of breath holding with a visible and audible signal When the shutter opens instruct the patient to exhale relaxed the patient cannot inhale until gas sampling is performed The metronome indicates the end of gas sampling with a visible and audible signal Push the Done button to stop the measurement Push the Discard button to delete the measurement Practice operating mode Turning on the Practicing mode option lets the patient practice the complete measurement process without inhaling the measurement gas mixture Use the practice operating mode for a few measurements with a badly cooperating patient Piston Lung Function Test 97 Measurement modes Using the shutter You can select whether the shutter is closed or opened during breath holding If the shutter is closed the patient must make sure that he she holds th
58. V I TR RV TLC 36 58 35 25 96 33 02 90 i Raw 0 22 0 19 85 0 03 14 Compliance f Rin 0 17 0 04 Mv Dittusion i d Rex 0 21 0 02 S we Smoke et uum Req 0 14 0 03 9 P iih uH HE sRaw 0 86 0 14 iis THEE HEH HE sRin 0 78 0 20 Provocation REER f l sRex 0 95 0 08 Lx Handbook I Att TERI AE sGaw 1 04 1 16 111 7 10 683 MEE dre HP a sGin 1 28 4 93 H Audiometry HE dg i sGex 1 06 12 69 Se BF 40 76 41 44 SERI iii Gaw 5 36 32 81 LINK duc UE VERNER Gin 5 94 22 78 v Full graph Display Gex 4 88 58 65 EX Exit 5 Single graph 2 OnFly Analysis F ane erase RS WwW 156 84 95 42 Volume Time eo m ae a 8 T E det rt rc HANE i i AAAA AAAA ASAA NE ij 2 1 1 High Tao rca fas 1 H 1 10 Hmm 20 1 2 i 30 ici 40 50 B0 2 i t T i t i T d is Premises To get the IVC parameter value required to determine Thoracic Gas Volume measurement parameters e Perform an IVC measurement before the TGV measurement The advantage to this is that the TGV manoeuvre becomes simpler e Retrieve an IVC measurement from the database that looks recent e The IVC measurement can be performed even during the TGV measurement after shutter opening The advantage to this is that you get all the parameters in one Piston Lung Function Test 92 Measurement modes measurement the disadvantage is that the measurement is more complicated The system always selects the most recent IVC measurement result Prep
59. ae pei 12 Preparations ose ei n ee lite Soe a a a a 12 CAPACI GW eden dien e diu eld 3s teat E ec cond E E aa 73 Entering environmental data zoe o E dere eee Bai ines 73 Zeno Sets cuc E ut M 74 MIgas rerie nt aces ea qais eui Dah edes ut bete aan Steed 75 Measurement eyal ati N siad odiis iat cons bes beilo ordo atat it apes 75 jer gesiin d Exp 78 Niro ME Rp UR 78 PEUIUTIBE ee p tib cette ja tb eicit messe etaed Mee ou 78 Export report into the graphical formats eee 80 Interface to information Systems oor od nu ee road eed deed 8l Measurement modes Lire toon oer nita nd ponen Repo E pER RU SEE ERREAT RAT eL pM Se phe ae HERE Forced Vital Capacity sa renidet ce boat baeo Dole uie dde 82 Inspiratory Vital Capacity esae ttestaas aaae i ns 84 Maximal voluntary ventilatlO arai ione egere eo ee le ee teen ds 86 Isinomanoliet Gy AE EE eae cae acy acs nce aces aae san e editus e 88 Breath carbon monoxide monitoring eene 90 Thoracio Cras Volume v s ou Suc csond inei tobacco ace cod oret duet Eaa 92 Diffusion capacity testien ree oe pehe BA See Bh ia 95 Single Breath Diffusion capacity test 96 Intra Breath Diffusion capacity test eee e rte epe teen 101 Piston Lung Function Test 2 Coping ino ei cedo na et eaten een neo cursos 105 Maximum inspiratory and expiratory pressure esee 112 LGV AULT MOS od c ace e d Deas release Re UPA sla Mill I mde 114 PREJPOSE 25598 pred
60. ance Upon completing a provocation session a bronchial dilution is strongly recommended Electrocardiographyy SAd The software is able to launch and to transfer patient data to the external ECG software Cardiax So the user is able to maintence a single database while using the services of two different applications Piston Lung Function Test 44 The program s main functions System comparison table PDD 301 spf PDD 301 rpf PDD 301 sco PDD 301 o PDT 111 p PDT 111 d PRE 101 Spirometer Rhinomanometer Breath CO monitor Oscillometer Whole body Diffusion capacity Ergospirometer plethysmograph test PinkFlow flow meter Forced ex and inspiration Static vital capacity Maximal voluntary ventilation Nasal resistance optional optional Breath CO monitor Impulse oscillomerty Thoracic gas volume Airway resistance Work of breathing Compliance optional Diffusion capacity optional Ergospirometry ECG 12 leads Weight 220 g 220 g 420 g 2 5 kg 200 kg 5 5 kg 4 5 kg Size 150 82 150 82 190 138 260 155 1680 925 320 200 320 200 45 mm 45 mm 68 mm 160 mm 790 mm 240 mm 140 mm Power supply USB port USB port USB port 90 260 VAC 90 260 VAC 90 260 VAC 90 260 VAC 50 60 Hz 50 60 Hz 50 60 Hz 50 60 Hz Piston Lung Function Test 45 User interface US
61. aph Display Rend Single graph D Oy O Side by side All J Delete Volume Time 2 je wj ESSE E DTE ec ea YR cem MH EIE CRX 8 i t H 4 L 1 4 n i LIIS Li Piston Lung Function Test 112 Measurement modes Measurement process The following series of manoeuvres must be performed Place the nasal clip so the patient can only breathe through the mouth Have the patient breathe evenly relaxed Instruct the patient to take a complete deep breath When the patient began the deep inhalation press the Shutter button Have the patient try to exert as great force as possible exhaling against the shutter the current mouth pressure value appears on the screen Pressing the Shutter button again opens the shutter immediately Have the patient breathe evenly relaxed again Instruct the patient to exhale completely deep When the patient began the deep exhalation press the Shutter button Have the patient try to exert as great force as possible inhaling against the shutter the current mouth pressure value appears on the screen Pressing the Shutter button again opens the shutter immediately Push the Done button to stop the measurement Push the Discard button to delete the measurement m Correct PImax PEmax measurement Phases quiet breathing complete deep inspiration PEmax measurement quiet breathing complete deep expiration PImax measurement
62. appears WARNING No solution done yet Do you really want to exit provocation cycle Click on the Solution button to store the bronchial dilution A lung function test should be performed after the bronchial dilution in order to get evidence of the effectiveness of dilution To start a lung function test click on the Meas button and the previously specified measuring window opens Perform a few measurements and the Provocation test module will select the best results automatically After finishing click on the Provocation button at the Spirometry main menu and the Provocation test window reappears Results of the lung function test are stored automatically Piston Lung Function Test 120 Measurement modes Electrocardiography ISA Measurement goal The software is able to launch and to transfer patient data to the external ECG software Cardiax So the user is able to maintence a single database while using the services of two different applications Tiston MEM e liax Patient Record Sort Select Transfer Setup Help 2e M c iol s a 7 we E 09 4 00H Beh 2h RAFT Name Demo Patient E 30 06 2010 08 33 Precordial 105 SpO2 Demo E 435 SpO2 Jeno Audiometry 22 07 2010 13 19 Precordial 43s Code 111111 Born 01 01 1981 Sex Male 177 Height cm 78 Weight kg Doctor Diagnosis
63. aration TGV is a complex measurement requiring considerable cooperation from the patient Seat the patient in the cabin Set the chair height Set the height of the patient circuit Place the nasal clip so the patient can only breath through the mouth Explain the exact measurement process to the patient Prepare the patient for unexpected and unusual events such as shutter closing Close the cabin door Set the speaker volume Measurement process The following series of maneuvers must be performed The metronome turns on after the measurement starts The countdown to thermal compensation begins The patient can practice breathing to the metronome during the waiting period the current respiratory frequency is continuously displayed in the top part of the measurement window After the waiting period tell the patient to evenly breath according to the metronome The current respiratory frequency is continuously displayed in the top part of the measurement window in the Breathing frequency field In case of respiratory frequency that is extremely different from the settings the field changes to red When the patient is breathing evenly according to the metronome press the Start button to start Resistance then TGV loop recording During shutter closing have the patient try to perform even expiration and inspiration manoeuvres The patient does not have to exert too much force but has to suck on it and has to push against the
64. ata must be reentered BTPS The top right part of the individual measurement windows contain the BTPS data panel where you can enter the environmental data Automatic BTPS parameter measurement The Plethysmograph and the Diffusion capacity test has environmental data measurement unit These devices automatically measure the environmental data and display them in the BTPS panel Attention The Plethysmogram measures the environmental conditions inside the cabin Data measured in a long closed overheated cabin is not suitable for measurements with a separate device Piston Lung Function Test 73 Measurements Zero setting For exact volume measurement the zero setting of flow meter channel must be performed immediately before the measurement Preparation There cannot be any flow through the flow meter during zero setting so the patient cannot take the connected mouthpiece into the mouth Notice PD In case of Plethysmograph and the Diffusion capacity test pneumatic valves detach the flow meter from the pressure transducer so zero setting occurs automatically in the background Patient may continue breathing thru the flow meter Zero setting process The program automatically starts the zero setting process immediately before each measurement The system evaluates the data measured during the zero setting process and displays an error message and repeats the zero setting process if a Zero error is en
65. ational Viljanen 1981 On special request new reference value algorithms can be added to the system European Community for Coal and Steel Standardized Lung Function Testing by European Community for Coal and Steel published in 1983 Male TLC I 7 99H 7 08 0 70 RSD RV I 1 31H 0 022A 1 23 0 41 RSD FRC I 2 34H 0 009A 1 09 0 60 RSD RV TLC 0 39A 13 96 5 46 RSD IVC I 6 10H 0 028A 4 65 0 56 RSD FVC I 5 76H 0 026A 4 34 0 61 RSD FEV 1 0 I 430H 0 029A 2 49 0 51 RSD FEV 1 0 JVC 0 18 A 87 21 7 17 RSD FEF 25 75 l s 1 94H 0 043A 2 70 1 04 RSD PEF l s 6 14H 0 043A 0 15 1 21 RSD FEF 75 V s 5 46H 0 029A 0 47 1 71 RSD FEF 50 V s 3 79H 0 031A 0 35 1 32 RSD FEF 25 V s 2 61H 0 026A 1 34 0 78 RSD Raw kPa l s 0 22 fupper limit sGaw 1 kPa s gt gt 0 85 lower limit Tlco mmol min kPa 11 11H 0 066A 6 03 1 41 RSD Klco mmol min kPa l 0 011A 2 43 0 27 RSD Where A age 18 years 70 years H height 155 cm 195 cm Female TLC I 6 60H 5 79 0 60 RSD RV I 1 81H 0 016A 2 00 0 35 RSD FRC I 2 24H 0 001A 1 00 0 50 RSD RV TLC 0 34A 18 96 5 83 RSD IVC I 4 66H 0 024A 3 28 0 42 RSD FVC I 4 43H 0 026A 2 89 0 43 RSD FEV 1 0 I 3 95H 0 025A 2 69 0 38 RSD Piston Lung Function Test 161 Appendix l FEV 1 0 IVC FEF 25 75 PEF FEF 75 FEF 50 FEF 25 Raw sGaw Tlco Klco Where A age H height 76 l s l s l s
66. catheter 1 prior to removal Piston Lung Function Test 107 Measurement modes Correct position The oesophageal pressure is in counter phase with the spirogram It decreases during inspiration Incorrect position The oesophageal pressure in the same phase with the spirogram It increases during inspiration The balloon is inserted too deep into the stomach It has to be pulled up Premises For determination some parameters of the Compliance measurement there is a need to have the TLC and or TGV and or FRC measured previously The system provides a couple opportunities for that Prior to Compliance measurement make a TGV measurement Prior to Compliance measurement make a diffusion capacity test Retrieve from the database a TGV or diffusion capacity test result as an Actual measurement If there are more TLC values the system always selects the largest one Preparation Compliance measurement is a complex process requiring considerable cooperation from the patient e Inform patient on the process of the measurement e Prepare patient for the unexpected and unusual events like closing of the shutter during Static Compliance measurement e Pushing the Monitor button it is possible to monitor continuously the breathing of the patient The spirogram and the pressure of oesophageal balloon are displayed simultaneously e As it is described before insert the oesophageal balloon into the prop
67. ccessories The current Shipping contract contains the list of accessories included in the purchase price Optionally purchased accessories The following information must be provided when ordering accessories and disposables Description Type Part number Device type and serial number for which the accessories are used Piston Lung Function Test 131 EMC Guidance and manufacturer s declaration EMC GUIDANCE AND MANUFACTURER S DECLARATION Guidance and manufacturer s declaration electromagnetic emissions The PDD 301 r Rhinomanometer particular implementation PDD 301 s Spirometer is intended for use in the electromagnetic environment specified below The customer or the user of the PDD 301 r Rhinomanometer should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance The PDD 301 r Rhinomanometer uses RF RF emissions energy only for its internal function Group 1 Therefore its RF emissions are very low and CISPR 11 are not likely to cause any interference in nearby electronic equipment RF emissions Class B CISPR 11 Harmonic emissions Not applicable IEC 61000 3 2 Voltage fluctuations flicker emissions Not applicable IEC 61000 3 3 The PDD 301 r Rhinomanometer is suitable for use in all establishments including domestic establishments and those directly connected to the public lowvoltage power supply network that supp
68. co and PDD 301 rco Breath CO monitor installation Connect the USB cable to the device and to the PC Connect the blue connector of the twin tubing to the blue coded socket indicated with the Flow meter label and the white connector to the white coded socket Connect the yellow connector indicated with the Gas sample label to the yellow coded socket For the proper connection the lock should be turned 180 degrees clock wise Piston Lung Function Test 14 Installation For the connection push the PinkFlow flow meter into the quick connector For removal push the metal button The disc filter of the gas sampling tubing prevents the device from the contamination When the disc filter gets dirty it has to be replaced PDD 301 p Dose controlled drug nebulizer installation The PDD 301 p Dose controlled drug nebulizer can cooperate with any measurement device of the respiratory device family It is operated via the main system software Connect one end of the USB cable to the device the other end to one of the USB ports in the computer Piston Lung Function Test 15 Installation Installing the nebulizer head Pressure Output E Mouth Pressure C PRT 40 gt Pi VM 3434 I ing PRT 24 fe
69. conductance sGin Specific Conductance of Airways at Inspiration Specific airway conductance during inhalation sGex Specific Conductance of Airways at Expiration Specific airway conductance during exhalation BF Frequency of Breathing at Resistance Measurement Breathing frequency during resistance measurement W Work of Breathing at Resistance Measurement Breathing work during resistance measurement The following graphs are displayed during measurement e Volume time curve e Flow Pa Resistance loop xd P mouth Peab TGV loop Diffusion capacity test DJ Complex lung function test for the measurement of oxygen bounding capacity of the lung Detailed information may be found in the Measurement modes page 82 section Piston Lung Function Test 39 The program s main functions In this operating mode the device measures the following parameters TLC Total Lung Capacity Total lung capacity IVC Inspiratory Vital Capacity Total inspired volume after a full expiration IRV Inspiratory Reserve Volume The inspiration reserve volume is volume what the patient can inhale from the average inhalation endpoints of quiet breathings ERV Expiratory Reserve Volume The expiration reserve volume is volume what the patient can exhale from the average exhalation endpoints of quiet breathings TV Tidal Volume The average volume moved during quiet breathing RV Residual Volume Residual volume RV TLC Residual Volume Total Lung Capacity
70. countered Manual zero setting You can reset the currently selected device anytime with the Zero button next to the Device selection list in the program header Notice Zero setting is automatically performed before calibration Piston Lung Function Test 74 Measurements Measurement The individual measurement operating modes are detailed in the Measurement modes section page 82 Measurement evaluation You can simultaneously perform and display max 8 measurements Measurements deemed not appropriate can be deleted and a new one can be performed The system selects the best measurements based on different aspects for each measurement operating mode Sort order aspects Forced Vital Capacity Decreasing order based on FVC FEV 1 0 sum Larger values are better Inspiratory Vital Capacity Decreasing order based on IVC value Larger values are better Hyperventilation Decreasing order based on MVV value Larger values are better Rhinomanometry Increasing order based on RES 75 value Smaller values are better TGV and Resistance Decreasing order based on TLC value Larger values are better Or Increasing order based on Req value Smaller values are better Use the switches above the summary table to change the sort order Diffusion capacity test Decreasing order based on TLC value Larger values are better Piston Lung Function Test 75 Measurements Pairing Li In case of the Rhinoman
71. ctly connected to the public lowvoltage power supply network that supplies buildings used for domestic purposes Piston Lung Function Test 136 EMC Guidance and manufacturer s declaration Guidance and manufacturer s declaration electromagnetic immunity The PDT 111 pd Whole body plethysmograph and Diffusion capacity test is intended for use in the electromagnetic environment specified below The customer or the user of the PDT 111 pd Whole body plethysmograph and Diffusion capacity test should assure that it is used in such an environment IMMUNITY test IEC 60601 test level Compliance Level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact t8kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 96 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 t2kV for power supply lines t1kV for input output lines 1 kV line s to line s t 2 kV line s to earth 2kV for power supply lines 1kV for input output lines 1 kV line s to line s 2 kV line s to earth Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and vol
72. cycles lt 5 Uy gt 95 dip in Ur for5s 6 kV contact 8 kV air t2kV for power supply lines t1kV for input output lines 1 kV line s to line s 2 kV line s to earth 5 Ur gt 95 96 dip in Uy for 0 5 cycle 40 Ur 60 dip in U7 for 5 cycles 70 Ur 30 dip in U1 for 25 cycles Not applicable floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the PRE 101 Ergospirometer requires continued operation during power mains interruptions it is recommended that the PRE 101 Ergospirometer be powered from an uninterruptible power supply or a battery Power frequency 50 60 Hz magnetic field IEC 61000 4 8 Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE Uy is the a c mains voltage prior to application of the test level Piston Lung Function Test 145 EMC Guidance and manufacturer s declaration Guidance and manufacturer s declaration electromagnetic immunity The PRE 101 Ergospirometer is intended for use in the electromagnetic environment specified bel
73. d cede Measurement process The following series of manoeuvres must be performed e The patient must clean the nasal canals e Place the appropriate size nasal plug into the side opposite the measured one So if you would like to measure the resistance of the right nasal canal place the nasal plug into the left nostril and vice versa e Have the patient hold the appropriate size facial mask against his her face to prevent leaking e The patient can only breathe through the free nostril not through the mouth The patient has 60 second to perform the manoeuvres but usually a few even respiratory cycles are enough Push the Done button to stop the measurement Piston Lung Function Test 88 Measurement modes Push the Discard button to delete the measurement ml Correct Rhinomanometry measurement The patient breathes relaxed during the measurement Selecting the loop curve The system records several respiratory cycles during the measurement and by default displays their average However you have the option to view the curves one by one e Select the measurement you would like to modify from the measurement summary table e Click with the mouse on the spirogram the marker jumps to the next cycle e The system automatically recalculates the parameters Piston Lung Function Test 89 Measurement modes Breath carbon monoxide monitoring Measurement goal The goal of the measurement to fo
74. database Load Control buttons to display the selected measurements Measurement selection Measurements may be listed according to measurement type as well Data input form e Audiometry Title EE pE T j Identifying data i Mother s name O Female A Exit ano Eu 08 02 v eum m Postal code City v v Street Phone 5 Accessibility Mail Height e em Weight ei ka Body mass index List of incomplete fields Control panel Content of the Data input form can be set in the menu Setup Options Display Contents of Patient s Datasheet V bam database M H Body Mass Index Age 58 years List of empty fields First name Click on the items in the list to get detailed Lastname r information about the Omer s nome required data_ Birth date Sex w 3 ft X NC aH VCS oa z Identifying data Group of data essentially identifying the patient Name date of birth social security number sex etc Accessibility Patient s accessibility Address phone numbers e mail address Body mass index calculated value The patient s current body weight index square of the height of the patient in meter divided by body weight List of incomplete fields A list of fields that either have to be completed and are still empty or that have been filled out incorrectly Control panel Basic database operations n
75. ducts meet the provision of the Council Directive 93 42 EEC for medical devices All supporting documentation is retained under the premises of the manufacturer STANDARDS APPLIED EN 60601 1 EN 60601 1 2 EN 30993 1 EN 980 EN 1441 NOTIFIED BODY TUV Rheinland Product Safety GmbH Germany D 51105 K ln Am Garuen Stein EC CERTIFICATES MAIN ACCESSORIES ISO 13485 2003 Registration Nr SX 600174060001 Report Nr 28202723002 CE 0197 Safety test Report Nr 28203472001 ENC test Report Nr 28203473001 PCS 3000 Calibration syringe PBF 30 Bacterial filter MPA 30 Mouth piece BUDAPEST 11 MAY 2007 Korn l NAGY Mr 2 Quality Assurance Manes Piston Lung Function Test 156 EC Declaration of Conformity PISTON Ltd 1121 Budapest Pihen u 1 C pavilon HUNGARY Tel 36 1 275 0033 Fax 36 1 275 0034 http www pistonmedical com Email info pistonmedical com EC DECLARATION OF CONFORMITY MANUFACTURER Piston Ltd Hungary H 1121 Budapest Pihen u 1 c PRODUCT Calibration Syringe for spirometers MODEL NUMBER PCS 3000 CLASSIFICATION Class lla Council Directive 93 42 EEC of MDD Annex V Article 3 DECLARATION We herewith declare that the above mentioned products meet the provision of the Council Directive 93 42 EEC for medical devices All supporting documentation is retained under the premises of the manufacturer STANDARDS APPLIED EN 6
76. e breath and does not press it onto the shutter because this increases the alveolar pressure and change the level of diffusion If the shutter is open the patient must make sure not to inhale or exhale during breath holding because this changes the gas concentration in the patient s lung and effects measurement accuracy Measurement instructions During measurement the system continuously indicates the upcoming manoeuvre It is important to note that the system does not indicate the immediately performed task but the next in line For example Complete deep inhalation appears towards the end of the complete deep exhalation however it is obvious that inhalation comes after the completely finished exhalation and not immediately Possible error messages during closed shutter breath holding Mouth pressure out of allowed range during breath hold time Repeat the measurement if possible Due to the mouth pressure variation the measured Tlco Dlco and Klco values can be used only for orientation Valsalva or Miller effect The patient must take care to hold his her breath and not press it onto the shutter and not try to inhale This can increase or decrease the alveoral pressure and change the diffusion amount Possible error messages during open shutter breath holding Expiration during inspiration of gas mixture Repeat the measurement if possible If the shutter is open the patient must take care not to i
77. e and manufacturer s declaration electromagnetic immunity The PDD 301 p drug nebuliser is intended for use in the electromagnetic environment specified below The customer or the user of the PDD 301 p drug nebuliser should assure that it is used in such an environment IMMUNITY HEC S060 eomplance Electromagnetic environment guidance test test level level Portable and mobile RF communications equipment should be used no closer to any part of the PDD 301 p drug nebuliser including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF IEC 61000 4 6 0 15 80 MHz 0 15 80MH2 Z LI7VP Radiated RF IEC 61000 4 3 d 1L17VP 80 MHz to 800 MHz d 2 33VP 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Ko NOTE 1 At80 MHz and 800 MHz the higher frequency range applies NOTE2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures
78. e carrier and Piston Ltd or its representative Limited liability Piston Ltd and its carriers according to the valid laws do not accept any responsibility for any individual unforeseeable direct or indirect damages including loss of business profit interruption of business activity loss of business data or any other damages due to financial loss resulting from the use or non usefulness of the product Safety instructions To avoid possible damages and accidents please pay attention to the following safety instructions e Make sure the mains voltage is the same as that on the product label e Make sure the connection cable is not damaged e Take care of your device according to the maintenance section e Only use the device according to the manual e Do not use any accessories not recommended for the device e Store the device in a dry place e Keep the cable away from heat source sharp objects rough surfaces and check the cable s good condition e Do not expose the device to direct sunlight or strong light more than 1500 lux e Do not use the device in a highly dusty environment e Do not use the device in a highly vibrating environment e Take care to ensure the current environmental conditions The device complies with the contents of the detailed standards in the E section 150 page Piston Lung Function Test 124 Technical data Shipping conditions Air temperat re aste eec de ue dein e aae 3
79. ensor disinfections or replacement IMPORTANT If work environment conditions temperature air pressure humidity change significantly re calibration is recommended Flow meter calibration The flow meter volume calibration ensures maximum accuracy and is an efficient way to check the proper operation It is possible to perform measurements without calibration but at least 596 additional error must be taken into account Connecting the flow meter Connect the patient side the bigger diameter side of the PinkFlow flow meter of the Spirometer or the Rhinomanometer directly to the calibrating pump Connect the patient side of the flow meter of Plethysmograph or Diffusion capacity test directly or with the included coorrugated tube to the calibrating pump Calibration process Spirometry Calibration In case of several connected devices select the one to be calibrated from the Device selection list The calibration should be performed in two steps At first the peak flow should be at about 1 0 I s and afterwards at about 5 0 l s Press the Start button to start calibration Push the fully drawn out calibrating pump with uniform speed all the way in then pull it out all the way Horizontal lines on the loop curve indicate optimal flow limits During calibration make sure the calibration curve peaks are within these lines The number of calibration cycles may be set as described in the Settings section page 5
80. ents Cup File name LocalDisk P Files of type Programs Select Setup Language fo Select the language to use during the installation Fs 16 Setup PistonXP Welcome to the PistonXP Setup Wizard This will install PistoniXP on your computer It is recommended that you close all other applications before continuing Click Next to continue or Cancel to exit Setup Click on the Start menu and select Run Click on the Browse button and select the install program When installing from the CD select the CD drive Find the pxp setup exe file in the Programs folder Click OK The install program starts Select the preferred language for the setup and the installed software Click OK A welcome screen appears just click Next Piston Lung Function Test 26 Installation ie Setup PistonXP License Agreement Please read the following important information before continuing Please read the following License Agreement You must accept the terms of this agreement before continuing with the installation LICENSZ SZERZODES PistonXP v gfelhaszn l i licensz szerz d s FONTOS MEGJEGYZ S A TERM K TELEP T S VEL EGY B HARMADIK F LT L M S GY RT T L SZ RMAZ SZOFTVERTERM KEK IS TELEPITESRE KERULNEK MELYEK SAJ T V GFELHASZN L I LICENSZ SZERZ D SSEL RENDELKEZNEK A FELHASZN L A PROGRAM TELEPITESEVEL A HARMADIK F LT L SZ RMAZ SZOFTVERTERMEKEK LICENSZ SZERZ
81. eparation distance Conducted RF 3 Vims 3 Vims IEC 61000 4 6 0 15 80 MHz 0 15 80 MHz d 1174P Radiated RF 3 V m 3 V m IEC 61000 4 3 80 MHz 80MHz a 2 5GHz 2 5GHz d m LIP 80 MHz to 800 MHz d 2 33NP 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Ko NOTE 1 At80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the PDD 301 r Rhinomanometer is used exceeds the applicable RF compliance level above the PDD 301 r Rhinomanometer should be observed to verif
82. er depth The pressure of the oesophageal balloon displayed over the spirogram with a light blue line The pressure of the oesophageal balloon is displayed during the preparation and the measurement furthermore during browsing when a given measurement is selected Piston Lung Function Test 108 Measurement modes Measurement process The following series of manoeuvres must be performed Starting the Monitor mode the metronome starts as well Patient may practice breathing according to the metronome in Monitor mode The actual breathing frequency is displayed in the middle of the upper part of the screen When the oesophageal balloon is at the proper position the oesophageal pressure is in counter phase with the spirogram When the patient is breathing quietly and evenly push the Cdyn button to start the measurement After three quiet breathing cycles the Dynamic Compliance loops are recorded Pushing the Cstat button the Dynamic Compliance mode is finished and the a Shutter button becomes active Instruct the patient for the full deep inspiration and afterwards for a quiet even and very slow exhalation 200 500 ml sec Push the Shutter button as the patient starts the full deep inspiration The Static Compliance measurement starts automatically as the patient starts expiration During the expiration the Shutter closes automatically after certain exhaled volumes and interrupts expiration When the Shutter is c
83. er uses RF RF emissions energy only for its internal function Group 1 Therefore its RF emissions are very low and CISPR 11 are not likely to cause any interference in nearby electronic equipment RF emissions Class B CISPR 11 The PDD 301 p drug nebuliser is suitable for Harmonic emissions use in all establishments including domestic Class B establishments and those directly connected IEC 61000 3 2 to the public lowvoltage power supply network that supplies buildings used for domestic Voltage fluctuations purposes flicker emissions Complies IEC 61000 3 3 Piston Lung Function Test 140 EMC Guidance and manufacturer s declaration Guidance and manufacturer s declaration electromagnetic immunity The PDD 301 p drug nebuliser is intended for use in the electromagnetic environment specified below The customer or the user of the PDD 301 p drug nebuliser should assure that it is used in such an environment IMMUNITY IEC 60601 Compliance Electromagnetic test test level Level environment guidance Floors should be wood Electrostatic concrete or ceramic tile If discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 6 kV contact t 8 kV air t2kV for power supply lines t1kV for input output lines t 1 kV line s to line
84. ers Cdyn Dynamic Compliance Dynamic Compliance of lungs Edyn Dynamic Elastance Reciprocal ratio of the Dynamic Compliance Cstat Static Compliance Quasi static compliance of lungs Estat Static Elastance Reciprocal ratio of quasi Static Compliance Wcomp Work of Breathing at Cdyn measurement Viscous work of breathing during Dynamic Compliance measurement ReqComp Equivalent Resistance Equivalent resistance Parameters listed below are calculated only when the value of the TLC was measured before of the Compliance measurement at TGV or Diffusion capacity test mode Cdyn TLC Dynamic Compliance Total Lung Capacity Ratio of Dynamic Compliance and TLC Cstat TLC Static Compliance Total Lung Capacity Ratio of Static Compliance and TLC Cdyn FRC Dynamic Compliance Functional Residual Capacity Ratio of Dynamic Compliance and FRC Cstat FRC Static Compliance Functional Residual Capacity Ratio of Static Compliance and FRC Cdyn TGV Dynamic Compliance Thoracic Gas Volume Ratio of Dynamic Compliance and TGV Cstat TGV Static Compliance Thoracic Gas Volume Ratio of Static Compliance and TGV Piston Lung Function Test 42 The program s main functions Rhinomanometry L1 P Measuring the nose airway resistance Detailed information may be found in the Measurement modes page 82 section In this operating mode the device measures the following parameters Flow 50 Pa The flow speed at 50 Pa drive pressure Flow 75 Pa T
85. ew patient modification store You have to close and re open Patient s Database to apply changes Piston Lung Function Test 63 Patient database Patient s personal data The program can store an arbitrary number of patients Pink fields indicate fields that have to be completed Anthropometrics data You have to enter the patient s body mass and height These data are required to calculate reference value The database stores the body mass and height of the patient for each visit so changes may be followed in time New patient To enter a new patient press the New Patient button Complete the fields and make sure that two patients cannot have the same identifier To store the patient press the Save button You will receive feedback about the success of data storage If you do not wish to save the data press the Cancel button Modify data Select the patient to modify Click on the Modify button After modification press the Save button You will receive feedback about the success of data storage If you do not wish to save the modified data press the Cancel button About deleting To preserve consistency and for future searches it is not possible to delete from the database All diagnosis has traces in the database Piston Lung Function Test 64 Patient database Finding a patient in the database The top section of the patient database window is the search block You can search based on se
86. fects the measurement results Marker Gas concentration panel CH4 0 2265 0 2265 co 0 1595 0 1595 coz 40715 4 0715 WOY 4 8625 4 8625 ccc Is Correct Diffusion capacity measurement Phases quiet breathing complete deep expiration even gas mixture inspiration slow and even expiration during gas sampling Incorrect marker positions The marker is too much to the left The marker is too much to the right at the beginning of the expiration and the CO curve is not straight yet curve Piston Lung Function Test 104 Measurement modes Compliance PD Measurement goal The primary goal of the measurement is to get the compliance of the lungs or with other words to determine the change of the lungs volume as a function of the pressure against the wall of the lungs There is a possibility to measure the Dynamic and Static Compliance sequentially during one manoeuvre To get the value of the Transpulmonary pressure we have to measure the pressure of the intrapleural cavity with the help of oesophageal balloon Pyp Pay Ppr where Prp Transpulmonary pressure Pay Alveolar pressure Pp Pleural pressure oesophageal pressure E ERG ones o v z BENE ls OB A TUV Paciensek Be lit sok S g 2008 04 21 11 20 12 E Paciensek EOS a Wie Kovacs Janos 94kg 170cm
87. fied Body Dipl Ing I M Cologne 20 03 2007 T V Rheinland Product Safety GmbH Am Grauen Stein D 51105 K ln Accredited by Zentralstelle der Lander f r Sicherheitstechnik ZLS and Zentralstelle der Lander f r Gesundheitsschutz bei Arzneimitteln und Medizinprodukten ZLG Notified under No 0197 to the EC Commission The CE marking may be used if all relevant and effective EC Directives are complied with CE 10020 12060 Piston Lung Function Test 149 EC Declaration of Conformity EC DECLARATION OF CONFORMITY PISTON Ltd 1121 Budapest Pihen u 1 C pavilon HUNGARY Tel 36 1 275 0033 Fax 36 1 275 0034 http www pistonmedical com Email info pistonmedical com EC DECLARATION OF CONFORMITY MANUFACTURER Piston Ltd Hungary H 1121 Budapest Pihen u 1 c PRODUCT Spirometer IBM PC based MODEL NUMBER PDD 301 s CLASSIFICATION Class lla Council Directive 93 42 EEC of MDD Annex V Article 3 DECLARATION We herewith declare that the above mentioned products meet the provision of the Council Directive 93 42 EEC for medical devices All supporting documentation is retained under the premises of the manufacturer STANDARDS APPLIED EN 60601 1 EN 60601 1 2 EN 30993 1 EN 980 EN 1441 NoriFIED BODY T V Rheinland Product Safety GmbH Germany D 51105 K ln Am Garuen Stein EC CERTIFICATES ISO 13485 2003 Registration Nr SX 6001
88. flow speed appr 30 Pa l s Dead space with bacterial filter appr 180 ml Heated screen temperature cos out RE estes 34 C 42 C Warm up tme spessastaverakesssdeacensscuaretossaedeavaseceenecseuntaye 15 minutes Sampling frequency PDD 301 device Tanuly 5 5 aee esie n On ANS 100 Hz PD TLL device family iriennet 250 Hz Other data Analog digital converter resolution esses 12 bit Piston Lung Function Test 125 Technical data Electrical data The connected computer s and printer s electrical data is found in the respective manufacturer provided specifications The following values apply only to the Piston Ltd manufactured devices PDD 301 s Spirometer PDD 301 p Dose controlled drug nebulizer PC connection edt renati Optically isolated USB 1 1 Mains voltage iat edidit cen espu deitatis 230 VAC MAins TreQuenCy RD 50 60 Hz Power COBSUITIpUORS 4s pocos datas ea der tone b iuto ovre esit evo eus 80VA PDT 111 p Whole body Plethysmograph PG COBBEClon einn tenete Optically isolated USB 1 1 Mains Voltage 2st Cu ER MEM EMT ER VERE 90 264 VAC Mains frequency iieisee osos tee reo een PR ER e ONU P pd ry eISS 50 60 Hz Power consumption 2245 AAG max 50 VA PDT 111 d Diffusion capacity test PC connection ose etie Optically isolated USB 1 1 Maths VONAGE auo Coole potest aee pene 90 264 VAC Mains freque
89. fusion time Inspiration Breath Hold Expiration Gas Sample 1 29 45 Ogilvie method Period start Start inhalation 1 Period end Start gas sampling 4 Jones and Meade method Period start Start inhalation 1 3 2 Period end Middle of gas sampling period 5 Epidemiologic Standardisation Project method Period start Middle of inhalation period 3 Period end Start gas sampling 4 Barometer calibration It is possible to exactly set the environment pressure measuring barometer Enter the exact environmental pressure value and press the OK button Piston Lung Function Test 60 Settings Calibration before all measurement You can select to have automatic Zero setting and automatic calibration of gas analyzer before each test Recommended option Using the shutter You can select to have the shutter closed during breath holding If the shutter is closed the patient has to make sure to hold the breath and not to press the shutter because this can increase alveolar pressure and change the level of diffusion If the shutter is open the patient has to make sure not to inhale nor exhale when holding the breath because this changes the gas concentration in the lung and effects the measurement accuracy Limit values during breath holding If you select the Shutter close option you can enter the limit value for mouth pressure fluctuation beyond which the device emits a warning If you select the Shu
90. going to use it unselect the Shutter option Piston Lung Function Test 102 Measurement modes Measurement instructions During measurement the system continuously indicates the upcoming manoeuvre It is important to note that the system does not indicate the immediately performed task but the next in line For example Complete deep inhalation appears towards the end of the complete deep exhalation however it is obvious that inhalation comes after the completely finished exhalation and not immediately Possible error messages during and after gas sampling Too short expiration time The patient did not exhale long enough for reliable gas sampling If the gas concentration curves and the measured values appear correct you can keep the measurement Piston Lung Function Test 103 Measurement modes Measurement refinement The system automatically optimizes the gas sampling position but manual refining may be needed e Select the measurement to be refined in the measurement summary table e The gas sampling marker appears on the spirogram e Use the arrows on the gas concentration panel to move the marker left and right e Use the carbon monoxide CO curve purple graph to find the optimal marker position where part of the curve inside of the markers almost straight but it is close enough to the curve inflexion point e When manually setting the marker you have to be careful because it significantly af
91. he PinkFlow flow meter If there is no possibility to provide a clean PinkFlow flow meter prior to each patient you have to use a bacterial and viral filter to avoid cross contamination Both PBF 30SU and PBF 100SU bacterial and viral filter can be used Connect one PBF 30SU bacterial and viral filter to bigger diameter end of the PinkFlow flow meter Connect one MPA 30 mouthpiece to the bacterial and viral filter Connect one PBF 100SU bacterial and viral filter to bigger diameter end of the PinkFlow flow meter Connect one MPA 30 mouthpiece to the bacterial and viral filter Piston Lung Function Test 11 Installation PDD 301 r Rhinomanometer installation 4M 41280 AM 41281 4M 41282 PDD 301 5 PPF 186 28 Connect the USB cable to the device and to the PC Connect the blue connector of the twin tubing to the blue coded socket indicated with the Flow meter label and the white connector to the white coded socket Connect the green connector of the nasal pressure tubing to the green coded socket For the proper connection the lock should be turned 180 degrees clock wise Piston Lung Function Test 12 Installation The disc filter of the pressure port prevents the device from the contamination When the disc filter gets dirty it has to be replaced For the connection push the PinkFlow flow meter into the quick connector For removal push the metal button Select a proper size Nasal
92. he flow speed at 75 Pa drive pressure Flow 100 Pa The flow speed at 100 Pa drive pressure Flow 150 Pa The flow speed at 150 Pa drive pressure Flow 300 Pa The flow speed at 300 Pa drive pressure The following graphs are displayed during measurement e Volume time curve e Flow Pc Resistance loop Provocation test The complete pharmaco dynamic test is fully supported by the dose controlled drug nebuliser Thanks to the exact dosage control variations of the lung function parameters can be followed up as a function of inhaled agent More detailed description can be found at the Measurement modes 82 page chapter Piston Lung Function Test 43 The program s main functions Safety precautions A The dose controlled drug nebuliser can be used only by the specially trained personnel Use only water solvent agent pH 2 5 4 0 If the solvent s chemical properties out of this range please contact the manufacturer of the patient circuit Intersurgical Ltd Crane House Molly Millars Lane Wokingham Berkshire RG41 2RZ England Tel 44 1734 795579 Provocation test can be proceeded only at the institutions which have all the necessary human and objective conditions of resuscitation It is prohibited to use the drug nebuliser in continuous mode The maximal continuous working period is 15 seconds and afterwards a 30 second idle period is requested Usage of the drug nebuliser requests constant surveill
93. he following have to be taken into the consideration during installation and operation e Do not install the device in a draughty place e There must not be a radiating heat source radiator sunny window within 1 meter e Air conditioning unit s orifice within 1 meter e Open window or door during measurement Piston Lung Function Test 20 Installation PDT 111 pd Plethysmograph and diffusion capacity test installation VM MP 2000 FM 15000 HM PBF 30 F fh e A LA 96 N zi pg p OOo Ooo SHUTTER HEATING FLOW GAS SAMPLE viv iHi Hi FM 15000 TT Part number Description Comment VM MP 2000 Rubber mouthpiece PBF 30 Disposable bacterial and viral filter FM 15000 HM Heated metal screened flow sensor FM 15000 TT Pneumatic twin tube MSAOE LA 96 N Demand valve Only with diffusion capacity test PPBF 900 PermaPure capillary with bacterial filter Only with diffusion capacity test Piston Lung Function Test 21 Installation Measurement head support with metronome Connect the cable from the measurement head support to the connection labeled Es gl UB siad Push the valve disc up to the magnetic valve shaft SV 36 Use the draw latch to fix the cabin valve manifold onto the measurement head support Only for diffusion capacity measurement DJ Screw the Demand valve onto the valve manifold Only for diffusion capacity measurement DJ Co
94. i iri sis EMI e ENERO suaiudavecacessucetastahsauiiposarenscaaestesese 122 The PREJPOST measurements ui ce e Perseo Ete dat Ceo Aser eec 122 Retrieve Hed urere Dios second doch od de elisa tpe cau rescate ated 122 RPL COME AL OE uou edax iei e ud Pele trece usu Eu iE du 122 PH DDS e uot db E EE er EE 123 Technical data auia tn Meri APER Go XE IRI PROEN TR ER oe e sosse ULE ME sasssa Eiso 124 Warranty e core n e vU aradtestfba pud a a ae te 124 Limited WAAL Yarra a eot t vei ea oh at fa e RR d een LUNA a edd 124 Satet o DEui Lento oC EMERE e mota Rss sorde e todos te een esas in pipe aane 124 Informing values adel pace ted nid dese dati epus itssta bue cep e eds 125 El ctricakdata asus nat Qmd a eee se eS E N NN 126 M hanical data oso od it ae clea Sh ae a Racy ln SE lh eds 127 Gu ra teed VANES cot n le lo i EN eae ede 129 List OPAC CESS OME Senmon coto dedi det diia od easet eb tients nati Pa DAE d rper 131 Certificates of Quality Management System c eeeeeeee eere 148 EC Declaration of Conformity ccce eere ee eee eee ee ee eo eese eese seo see 150 PSD PONG qi P EEE TET cxcscoseocaweseeeee 161 European Community for Coal and Steel sees 161 IS EAS OM aen Soeta ots e bleed T a ic ede coal rossa ub Resa C End d eodd 163 Cotton and Dust Standard 3 2 uctor pete haat pbi duxi qur mdi ulubinans 165 CCHHBOSHSU S A e ve EC M E 167 Astrid IN Alto occ ossoe o
95. ically acquires it and lists all the requested tests Exporting Click on the LINK button in the main menu and open the Import Export window According to your frame system type click one of the HL7 or GDT buttons in the Export section The system automatically exports the results of the tests Filling special forms The system provides filling customer defined forms Templates of the forms can be compiled in any ASCII format HTML XML CSV etc Compilation of the form is the competence of the System administrator Filling a form User may select a form from the preinstalled templates Click on the LINK button in the main menu to open the Import Export window Click on the HTML button to open the Custom Report window Select the desired template from the a Templates list Click on the Select button and the form is automatically filled out Piston Lung Function Test 81 Measurement modes MEASUREMENT MODES Forced Vital Capacity garg Measurement goal The goal of the measurement is to get parameters of the volume forced expiration and inspiration I m Wa G r Doctor Dr Semmelweis Ign c OB A 2 T p 2007 08 02 11 48 33 S Patients Forced Vital Capacity Power A John 75kg 178cm BTPS 27E C 999 hPa 40 e esent 0 x 00 0 00 pens Warnings 5i asup S Animation EE mine
96. in the database e Click on the Diagnose icon to open Diagnose composer e Select the measurement mode or the Patient mode from the list to which you would like to add a comment e Enter the comment e Press the Store button to store the comment in the database attached to the measurement Previous comments Previously created comments for the given measurement mode can be viewed anytime in the History list The currently entered comment is not lost when viewing a previous or another measurement modes comments To display the comment select the measurement mode you would like to edit from the list Store To store curves marked Visible and Questionable press the Store button Successful data storage returns a feedback Printing Printable data is divided into several groups e Complex report on lung function tests FCV IVC MVV TGV TLCO Compliance Rhinomanometer Provocation test Audiometry Piston Lung Function Test 78 Measurements PRE POST The system can print two types of reports e Normal report Three measurements results simultaneously e PRE POST report Two measurements results simultaneously and their difference in absolute and percentage format Customized reports The printed report has the following parts Header Parameter table Graphs Comment The header is the only fixed part of the header the other three may be turned on and off arbitrarily only the desired parts
97. info pistonmedical com EC DECLARATION OF CONFORMITY MANUFACTURER Piston Ltd Hungary H 1121 Budapest Pihen u 1 c PRODUCT Whole body plethysmograph MODEL NUMBER PDT 111 p CLASSIFICATION Class lla Council Directive 93 42 EEC of MDD Annex V Article 3 DECLARATION We herewith declare that the above mentioned products meet the provision of the Council Directive 93 42 EEC for medical devices All supporting documentation is retained under the premises of the manufacturer STANDARDS APPLIED EN 60601 1 EN 60601 1 2 EN 30993 1 EN 980 EN 1441 NoriFIED BODY T V Rheinland Product Safety GmbH Germany D 51105 K ln Am Garuen Stein EC CERTIFICATES MAIN ACCESSORIES ISO 13485 2003 Registration Nr SX 600174060001 Report Nr 28202723002 CE 0197 Safety test Report Nr 28203472001 ENC test Report Nr 28203473001 PCS 3000 Calibration syringe PBF 30 Bacterial filter MPA 30 Mouth piece BUDAPEST 11 MAY 2007 Korn l NAGY Mr 2 Quality Assurance Manes Piston Lung Function Test 154 EC Declaration of Conformity PISTON Ltd 1121 Budapest Pihen u 1 C pavilon HUNGARY Tel 36 1 275 0033 Fax 36 1 275 0034 http www pistonmedical com Email info pistonmedical com EC DECLARATION OF CONFORMITY MANUFACTURER Piston Ltd Hungary H 1121 Budapest Pihen u 1 c PRODUCT Diffusion capacity test MODEL NUMBER
98. istonXP icon should be created on the desktop experienced users Click Next An install summary window appears and if all settings are acceptable Click Install The install process begins Please wait until it finishes installing the software After installing the software external components will be installed also The installation of the Oracle XE Database Server Client runs in background and the process can take several minutes Please wait until it finishes installing the software Piston Lung Function Test 28 Installation 18 Setup PistonXP Installing Please wait while Setup installs PistoriXP on your computer Installing FTDI USB Driver 1 Setup PistonXP Completing the PistonXP Setup Wizard Setup has finished installing Pistor lt P on your computer The application may be launched by selecting the installed icons Click Finish to exit Setup Finally USB Drivers are being installed Please wait until it finishes installing the software A window indicates the end of the installation Click Finish to close the install wizard This concludes installation Start the program The program automatically detects the connected devices Piston Lung Function Test 29 Maintenance Device maintenance MAINTENANCE Our lung diagnostics devices do not require special maintenance For continuous reliable operation take care of the following To prevent device co
99. ld assure that it is used in such an environment IMMUNITY IEC 60601 Compliance Electromagnetic environment guidance test test level level 9 9 Portable and mobile RF communications equipment should be used no closer to any part of the PDT 111 pd Whole body plethysmograph and Diffusion capacity test including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF IEC 61000 4 6 0 15 80 MHz 0 15 80 MHz d 1 17VP Radiated RF IEC 61000 4 3 d LI7VP 80 MHz to 800 MHz d 2 33NP 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Cp NOTE 1 At80 MHz and 800 MHz the higher frequency range applies NOTE2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM
100. lies buildings used for domestic purposes Piston Lung Function Test 132 EMC Guidance and manufacturer s declaration Guidance and manufacturer s declaration electromagnetic immunity The PDD 301 r Rhinomanometer particular implementation PDD 301 s Spirometer is intended for use in the electromagnetic environment specified below The customer or the user of PDD 301 r Rhinomanometer should assure that it is used in such an environment IMMUNITY test IEC 60601 test level Compliance Level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact t 8kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 96 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 t2kV for power supply lines t1kV for input output lines 1 kV line s to line s 2 kV line s to earth Not applicable Not applicable Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 Ur gt 95 dip in U for 0 5 cycle 40 Ur 60 96 dip in U for 5 cycles 70 Ur 30 96 dip in Uy
101. limit of the agent used e The nebulising time Dilution queue 2 minute elapsed e If the process interrupted by clicking on the Done button In this case the already inhaled dosage will be stored Normally a nebulising cycle should be followed by a lung function test In a special need the regular sequence can be overridden and the nebulising can be repeated but a warning appears The last maneuver was also nebulizing Before another nebulization you may do a measure Do you really want to do another nebulization instead If in spite of the warning you follow with nebulising again the inhaled dosage calculated as follows nthe case of Accumulate agent the dosage will be summed e In other case the new dosage is taken into consideration Piston Lung Function Test 118 Measurement modes Measurement cycles After nebulising a lung function test should be performed in order to check the influence of the inhaled agent To start a lung function test click on the Meas button and the previously specified measuring window opens Perform a few measurements and the Provocation test module will select the best results automatically After finishing click on the Provocation button at the Spirometry main menu and the Provocation test window reappears A message appears giving information on the numbers of performed cycles Results of measure imported Number of Cycles is n If the lung function test was omi
102. llow up the smoking habits of the patient and assist the smoking cessation program Attention Avoid measuring patients whose exhalation may content alcohol because the CO sensor of the device may get wrong oh Wy PinkFLOW ik 201006 10 08 44 fa Dg Ea ae Paciens 100kg 178cm 3f years MBTPS 25 ic 994 hPa 39 Eo iagnose Measure time pe Spiromety ame sO Bresthing frequency e Parameters amp Instructions 79 PREIPOST ag Setup 4 PARAM REF M O1 RSD t Calibration r aN bel yl ee argue C eS CO ppm 2 74 O di yi T y pa Y svc 4 13 ye vc oCOHb 0 24 3 Temp 25 00 wwe mw Hum 35 00 f TOV Press 1009 00 slo pitusion AA Compliance FX i 4 CO Test A Rhino D en Ue ET Q Press IMS INN E PNIS EOE QUU E E Provocation s s ae E i H d 1 ErgoSpiro s 40 a v Full graph BS racer tandhon roo OnFly Analysis RUE raph os A x sire LE Non Smoker f ELI aem T CO 0 ppm S LINK bee p i E i BHt 0s RS bit r H i j i el 4 3 T 1 FE rr del i e iti S 5 Piston Lung Function Test 90 Measurement modes Measurement process The following series of manoeuvres must be performed e Place the Nasal clip to avoid the breathing thru the nostrils e Perform at least 3 quiet breathings e Breath hold et least for 10 seconds e Slow and even full expiration The patient has 60
103. losed the Mouth pressure is recorded The Static Compliance manoeuvre can be finished reaching the FRC level or it is finished automatically when the expiration flow less than 10 ml s Bad dynamic or static maneuvers can be repeated within the 1 minute period but parameters will always be calculated form the last dynamic or static maneuver The system provides possibility for recording 8 consecutive Dynamic and Static Compliance measurement pairs Pushing the Done button the measurement can be finished Pushing the Discard button the measurement can be deleted Piston Lung Function Test 109 Measurement modes Marker Correct Compliance measurement Phases Quiet breathing Quiet breathing during recording of Dynamic Compliance loops Preparation for Static Compliance with deep inspiration Static Compliance measurement during slow and even expiration Returning to the relaxed breathing Selection of Dynamic Compliance loop During the Dynamic Compliance measurement more loops are recorded The system selects automatically the loop which is closest to the average of the all loops However there is a possibility to select the desired loop manually as well e Select the measurement to be refined in the measurement summary table e Click on the spirogram and marker jumps to the next cycle e All parameters will be recalculated automatically Manual correction The system calculates automatically the steepness of the Dy
104. lter must be connected before each patient measurement The height of patient circuit of the Plethysmograph and Diffusion capacity test is freely adjustable according to patient comfort Patient Recommended body position e Sitting on a chair e Straight back e Level head e Tight clothing or jewels must not prevent free breathing Directions Respiratory examination requires patient cooperation so patient preparation and instructions are important for the measurement e Let the patient know the measurement process and goal e Show the patient how to take in the mouthpiece especially in case of the bite grip mouthpiece used with Plethysmograph and Diffusion capacity test e Prepare the patient for any unusual and uncomfortable events such as shutter closing or breath holding e Incase of the Diffusion capacity meter it is possible to practice without inhaling the gas mixture Piston Lung Function Test 72 Measurements Calibration Regular calibration ensures maximum accuracy Automatic warnings Warning time interval can be entered for all device types When this expires the device warns the user to perform calibration again In this case it is recommended to perform the calibration Calibration is detailed in the Calibration section Page 67 Entering environmental data Entering exact environmental data is necessary for proper BTPS correction If the temperature humidity or air pressure changes the d
105. lume The expiration reserve volume is volume what the patient can exhale from the average exhalation endpoints of quiet breathings TV Tidal Volume The average volume moved during quiet breathing SVC Slow Vital Capacity Total expired volume after full inspiration The following graphs are displayed during measurement e Volume time curve e Flow volume loop Piston Lung Function Test 37 The program s main functions Maximal voluntary ventilation BHP A rarely used dynamic lung function test Details may be found in the Measurement modes page 82 section In this operating mode the device measures the following parameters MVV Maximal Voluntary Ventilation The maximum respiratory volume measured during voluntary respiration calculated for one minute MVV f Maximal Voluntary Ventilation Frequency The maximum respiratory frequency measured during voluntary respiration projected for one minute The following graphs are displayed during measurement e Volume time curve e Flow volume loop Breath CO measurement HEP Dp The device insures the measurement of breath carbon monoxide concentration It is inevitable in the smoking cessation program Details may be found in the Measurement modes page 82 section In this operating mode the device measures the following parameters CO ppm Breath CO concentration COHb Carboxyhemoglobin SVC Slow Vital Capacity The Slow Vital Capacity is the volume which was exhaled
106. ly breathe through the mouth Tell the patient the exact measurement process Prepare the patient for unexpected and unusual events such as gas mixture inhalation through the Demand valve and holding the breath Measurement process The following series of manoeuvres must be performed The patient must breathe evenly after the measurement started The Gas button is enabled after the third relaxed breath Instruct the patient to exhale relaxed deep completely Press the Gas button when the patient started the complete deep exhalation During the next inhalation the patient inhales the measurement gas mixture and must be instructed to inhale completely deeply When the shutter opens instruct the patient to exhale slowly and evenly at approximately 0 5 litre sec flow rate The metronome indicates the end of gas sampling with a visible and audible signal Push the Done button to stop the measurement Push the Discard button to delete the measurement Practice operating mode Turning on the Practicing mode option lets the patient practice the complete measurement process without inhaling the measurement gas mixture Use the practice operating mode for a few measurements with a badly cooperating patient Using the shutter If the patient circuit is equipped with the optional exhalation orifice and you are going to use it select the Shutter option If the patient circuit has no exhalation orifice or you are not
107. make it into the report Highlight rows To highlight odd rows at colour or grayscale printing select the Highlight odd rows checkbox Simplified report To print only the best measurements of all modes select the Just the best measure checkbox Piston Lung Function Test 79 Measurements Printing Before printing measurement results have to be stored so the printed reports can be followed up e Click the Print icon in the main menu e Select the graphs tables and manual diagnosis you would like to print e Select the report language e Select the report type normal or PRE POST e Click on a button in the Print preview section to view the print preview e After making the necessary settings click the Print button During printing graph display is similar to on screen display e Complete curve or only the representative curve section e One or more graphs Export report into the graphical formats This feature provides export of the printed report into the commonly used graphical formats Exported reports can be stored and for example sent as an attachment to an e mail Supported formats e PDF Adobe Acrobat document e GIF picture e JPEG picture e BMP Windows Bitmap picture e EMF and WMF vector graphics Settings The Export function is in the Report edition window e Click on the Print button at the main menu Contents and the format of the exported report are fully identical to the printed
108. n Lung Function Test 82 Measurement modes g IU 8 7 B 5 4 3 2 1 1 10 20 30 2 Correct FVC manoeuvre Phases quiet breathing deep inspiration forced exhalation forced inhalation return to normal breathing Miller Quadrant The Miller Quadrant an effective graphical tool which helps making the lung function diagnoses The vertical axle shows the ratio of FVC reference value and the measured value The horizontal axle shows the ratio of FEV 1 0 reference value and the measured value The diagram is divided into four quadrants e Normal e Restrictive e Obstructive e Combined FVC i i pog bo e 0 OBSTRUCTIVE NORMAL 0 1007 ee ee eee ee ee Bf speedos becdestheckasterbectertnadeeceostecte jlcdechh tok hehe tak bl dhe kate ate 20 t 19 i o i 8 io i20 FEV1 Animation Animation with blowing away dandelions helps with motivating children to reac h their maximum effort during FVC manoeuvre Piston Lung Function Test 83 Measurement modes Inspiratory Vital Capacity Measurement goal The goal of the measurement is to get the parameters of the maximal inspiration Piston A et umm ee cese i IDE A 3 dd 207 08 02 115459 T v 2 Patients Inspiratory Vital Capacity Ix INS Smith John 75kg 178cm BTPS 27E C 999 EhPa 40 llagnose Measure tir 5 E Seay 0 d 00 0 00 ETES D
109. n y eee a dope acia oce tado eet esos duds 50 60 Hz Power COnsUmIptloti i eoo de erit eee tpe itia max 50 VA Piston Lung Function Test 126 Technical data Mechanical data PDD 301 s Spirometer FOV MEET eret tt eere vet e reos PPF 18 PinkFlow Dimensions eee H150 W82 D45 mm br po cede 210g Flow metet ces Lisi eae E E ED PPF 18 PinkFlow Dimensions eee H150 W82 D45 mm Weight e dose e be oue 210g PCD 702 Combo Device FIOwW MEtet eode acere etd atdbae at PPF 18 PinkFlow Heads t s cet atate a ipt ncc aei TDH 39 Noise attenuation of protecting case sees 40 dB Expected lifetime of the devices eo oe 5 years BlEp Ol SOUNG DIeSBUL Gimme phun De duda ui Ea 5 dB Fr quencies isisiccesneeies 125Hz 250Hz 500Hz 750Hz 1kHz Mole eon ne th ose gh c Lese E o 1 5kHz 2kHz 3kHz 4kHz 6kHz 8kHz Sound pressure Ieyel o ado eenosie 10dB HL 110dBHL Dimensions e Ripe hens H245 W 300 D 45 mm Weight including headset electrodes and flowmeter 2 3 kg For technical data of the ECG see the ECG s documentation PDD 301 sco and PDD 301 rco Breath CO monitor Flow Metehan oce tete rtt p re er bR RUM PPF 18 PinkFlow Dimensions cere H 185 W 140 M 60mm bdpao 650g PDD 301 p Dose controlled drug nebulizer Dimensions eene H 260 W 160 D 110mm Weight e eed es 3 5kg Piston Lung Fu
110. namic and Static Compliance loops However there is a possibility to modify the steepness manually as well e Select the measurement to be corrected e The steepness of Dynamic and Static Compliance loops can be corrected separately in the Setup panel at the a Correction filed e All parameters will be recalculated automatically Piston Lung Function Test 110 Measurement modes Selection of TLC or TLC display mode There are two possibilities for interpretation of Compliance loops which can be selected at Setup panel in Scale section e Litre The gradation of vertical axle is in absolute volume e TLC The gradation of vertical axle is in percentage of TLC value Warning If there is no available TLC or RV value it is impossible to display the Compliance loops in TLC mode Piston Lung Function Test 111 Measurement modes Maximum inspiratory and expiratory pressure Measurement goal The goal of the measurement is to measure the respiratory muscle strength e Maximum inspiration pressure e Maximum expiration pressure Gro Doctor Dr Semmelweis Ignac 8 A 2007 08 02 12 20 04 Maximal Respiratory Pressure Ct Smith John 75g 478cm BTPs B7EC S99 Era BO Ev a a a im NITE CEU EO m 1 Parameters Instructions PARAM REF M 01 RSD al PE max 4 98 PI max 5 01 vie acces a erectones v Full gr
111. ncentration mode the concentration of the agent should be entered in the Concentration field Setting dilution sequence Using the Dilution sequence the Dilution queue table should be filled in Type of nebuliser cup Using the Auto mode the nebuliser cup has to be selected Purple 1 2 micron 0 12 g min or e Green 3 5 micron 0 3 g min Bronchial diluting agent It is strongly advised to finish the provocation test with inhalation of a bronchial diluting agent Select the bronchial diluting agent from the scrolling down list To enter a new bronchial diluting agent click on the New button Selecting type of lung function test and parameters To make the provocation sequence simpler and more transparent only one type of lung function tests can be used The type of lung function tests and the 3 parameters involved should be selected prior to the Basic measure basic measurement E Param terek Ge M r si Instrukci k DA PRE POST A Figyelmeztet sek add Beallitasok M r si m d 1 Param ter 2 Param ter 3 Param ter Forszirozott Vit lkapacit s v FVC 70 1 FEV 0 70 B PEF v Gg Provok l anyag mg Lung function test selection Select the desired type of lung function tests from the Measure Mode scrolling down list List of the available parameters for the selected type are actualised automatically Parameter selection Select the parameters to be followed up from the 1st Parameter 2nd Parame
112. nction Test 127 Technical data PDT 111 p Whole body Plethysmograph Flow meter eeeeeeeeerene Heated stainless steel screen Reference cabin volume sss 25 litres Basic design PDT 111 p and PDT 111 pd Cabin dimensions H 1680 W 925 D 790 mm Cabin volume user o ree iie vetet INIT 910 litres Cabin welphl 25 45 ederet asp qiu De N 200 kg Wheelchair design PDT 111 pwc Cabin dimensions H 1680 W 925 D 1240 mm Cabin VOLUME a A a RAN 1160 litres Cabin Wels Bto enar e EEE E R muda 240 kg PDT 111 d Diffusion capacity test FIOW SOnSODS Se vea deese iue ta Heated stainless steel screen Gas mixture CO 0 3 CH4 0 396 and synthetic air Gas cylinder tr tete 10 liter aluminium Dimensions without patient circuit H 250 W 475 D 155mm Weight without patient circuit esee 5 6 kg G s alid yZet zen eate tentes bea CRUS multi channel fast NDIR Piston Lung Function Test 128 Technical data Guaranteed values PPF 18 PinkFlow flow meter jb c PPF 18 Principle of operation ess Symmetric Pitot tube POW Scu c Et 18 I s Dead space ect eco onde UR T Miet HA aer Rance 36 ml ReSISLADeR oo ecoute toe aia sae cid 60 Pa l s 15 l s M eIgE cos tevece E aera eal Age ena em 34 gramm PDD 301 Spirometer and Rhinomanometer FIO Mete
113. nd has to hold the breath for a certain period of time and afterwards has to exhale slowly and evenly e Intra Breath Without breath holding method An alternative method for diffusion capacity measurement for the poorly cooperating patients who are unable for the breath holding manoeuvre It is enough for the patient to make a deep inspiration from the gas mixture and afterwards the patient may start the slow and even expiration immediately After changing the gas cylinder enter the actual gas concentrations according to Certificate issued by the Filling station as described in the Installation page 8 section Piston Lung Function Test 95 Measurement modes Single Breath Diffusion capacity test The Single Breath method is the standard way for diffusion capacity test Measurement goal The primary goal of the measurement is to get the oxygen binding capacity of the patient s lung Transfer factor calculated for carbon monoxide Functional residual capacity Total lung capacity Residual lung capacity IMPORTANT There must be at least 5 minutes between measurements so the measurement gas mixture can completely clear out from the patient s lung g G r Doctor Dr Semmelweis Ign c x mE cun S NA m i Emm 2007 08 02 12 10 10 TUV Diffusion Capacity Z Patients SL Smith John 75kg 178cm BTPS 27C 99
114. ng system High pressure gas cylinder Pressure reductor Main valve Pressure limiting safety valve Demand valve which ensures gas amount required by the patient s inhalation Gas analyzer PDT 111 d and PDT 111 pd D The patient s exhaled has mixture must be sampled and analyzed to determine diffusion capacity Parts of the gas analyzer e Gas sampling capillary e PermaPure capillary moisture exchanger to normalize the humidity of the gas samples e Sampling pump vibrating membrane design e NDIR Non Dispersive Infra Red multi channel quick gas analyzer Environment status measurement module PDT 111 p PDT 111 d and PDT 111 pd PD BTPS correction requires the measurement of the following environmental data e Environment temperature e Environment relative humidity e Atmospheric pressure Power supply PDT 111 p PDT 111 d and PDT 111 pd PA Medical design switching power supply which enables operating the device from any mains voltage e Mains voltage 90 264 VAC Mains frequency 50 60 Hz Piston Lung Function Test 7 Installation INSTALLATION Electric shock protection The electric shock protection instructions in this section must be followed Only Piston Ltd as manufacturer or its authorized distributor s personnel or the distributor s representatives may install the lung diagnostics device The above mentioned companies only accept responsibility for systems installed by them Before in
115. nhale or exhale during breath holding This can change the gas concentration in the lung and effect measurement accuracy The patient did not breath in the measured RV value is correct but Tlco Dico and Klco values are invalid Since methane quickly mixes into the lung the breath holding time has less effect on the RV and TLC measurement result However carbon monoxide diffusion greatly depends on breath holding time so transfer factor calculation is not possible Piston Lung Function Test 98 Measurement modes Patient made breathing during the breath hold time the measured RV TLC Tlco Dlco and Klco values are invalid As a result of inspiration the gas mixture in the lung is diluted to an unknown degree so measurement evaluation is not possible and the measurement must be repeated Possible error messages during and after gas sampling Inspiration during expiring gas mixture The patient breathed back during gas sampling so the results are inaccurate the measurement must be repeated Too short expiration time The patient did not exhale long enough for reliable gas sampling If the gas concentration curves and the measured values appear correct you can keep the measurement Piston Lung Function Test 99 Measurement modes Measurement refinement The system automatically optimizes the gas sampling position but manual refining may be needed e Select the measurement to be refined in the mea
116. nnect the Demand valve gas tube to the pneumatic quick connector in the cabin Piston Lung Function Test 22 Installation Connect the end of the pneumatic twin tube marked with the patient icon to the flow sensor Make sure the side marked with the patient icon Tb is on the side with gas sampling port Only for diffusion capacity measurement DJ Connect the gas sampling capillary to the Luer connector of the flow sensor Push the heated flow sensor into the valve manifold so the blue patient icon Tb faces the patient Connect the flow sensor heating cable to the connector marker fal z Wie Connect the pneumatic twin tube to the connector marked Ea Ke o The tube marked with the blue ring must be e 1 y connected to the connector marked with the patient icon Only for diffusion capacity measurement DJ WW Connect the gas sampling capillary to the connector marked Ie S i E Connect a new bacterial and viral filter and a rubber mouthpiece onto the flow sensor before measurement Piston Lung Function Test 23 Installation Connecting the gas cylinder to the PDT 111 pd Fix the gas cylinder into position If necessary replace the gas cylinder sealing ring Connect the pressure meter reductor to the gas cylinder Connect the high pressure gas tube to the cabin s pneumatic quick connector After opening the main valve of the gas cylinder set the secondary pressure t
117. ns unrelated to the evaluation can be hidden OnFly Analysis When this function is enabled the program monitors the patient s breathing during measurement separates normal breathing from deep exhalations and inhalations Active curves after measure In the Setup Options Operation menu item those curves can be selected which will be automatically indicated as active ones after each measurement e Just the best measure e First three e All measurements Curve magnification Click on any graph with the right mouse button Select the required size from the menu that appears The following magnifications are available Resistance measurement 0 5x 1x 2x Other measurements 0 5x 1x 2x 3x 5x Reference values The desired algorithm may be selected in the Setup Options Prediction menu item ECCS European Community for Coal and Steel Knudson Cotton amp Dust Crapo HSU sterreichisch To turn it off select the No reference values option Displayed parameters In the Setup Options Parameters menu you can enter which parameter to display on the screen and which one to print Piston Lung Function Test 56 Settings Devices Part of the parameters are for system data that can seriously effect measurement accuracy You can view these parameters through the user interface but they cannot be modified Only professionals can modify these data in the PistonXP ini file Measuring the environmen
118. ntamination and patient cross contamination use a new disposable bacterial and viral filter for all patient measurements The flow sensor must be contamination free The filter elements must be replaced according to instructions The PermaPure moisture exchange capillary must be replaced according to instructions The tubes must always be dry and cannot be broken Flow meter maintenance The flow meter condition and cleanliness affects measurement accuracy Cleaning measurement head main parts The individual patient circuit type installations are described in section Installation page 8 The plastic parts may be disinfected with cold water and appropriate chemicals for example Sekusept and may be used after rinsing and drying Cleaning the flow meter Unscrew the flow meter Clean the measurement screen in ultrasonic cleaner After it is completely dried reassemble the flow meter Cleaning the pneumatic twin tubes Disconnect the twin tube from the device and the flow meter Rinse the tube After it is completely dried reconnect the tube Cleaning the medication nebulizer patient circuit The medication nebulizer patient circuit must be rinsed at the end of each shift This prevents vaporized material drying into the system Piston Lung Function Test 30 Maintenance Breath CO monitor maintenance The expected life time of the CO sensor is 2 years For replacement of CO sensor please contact the local res
119. o 6 bar WARNING Always turn off the gas cylinder at the end of every shift and in all situations when diffusion capacity measurements are not made for longer periods Piston Lung Function Test 24 Installation PCD 702 Combo Device The Combo Device is technically equal to a fully functional PDD 301 s Spirometer a PDD 401 Audiometer plus an IMED Cardiax 12 channel ECG in a single housing Connect the USB cable to the device and to the PC Connect the Spirometer s patient circuit as described in the Spirometer s documentation Connect the ECG s patient circuit as described in the ECG s documentation Connect the Audiometer s patient circuit as described in the Audiometer s documentation Piston Lung Function Test 25 Installation Software installation Perform the installation from the included CD The most up to date version is available from our website http www pistonmedical com In the Downloads Software section Type the name of a program Folder document or Internet resource and Windows will open it For you Open Sit Cancel Browse Look in Administrator c le borland D userData padhxx Install e Administrator s Documents Application Data Contacts 48 e Cookies My Computer Desktop o Favorites Local Settings My Recent Documents I2 NetHood 3 PrintHood _ SendTo Start Menu D jTemplates My Network Places My Docum
120. ollowing error message appears Cabin pressure out of range In this case there is something wrong with the cabin tightness e Check that the cabin door is closed properly e Check that there is no foreign object between the cabin door and the sealing e Check that the cabin door sealing is intact Piston Lung Function Test 69 Calibration Diffusion capacity test calibration Diffusion capacity meter calibration is performed in the Spirometry Calibration menu In case of several connected devices select Diffusion from the Device selection list Before calibrating the diffusion capacity meter you have to ensure measurement gas supply e Open the gas cylinder main valve e Check that the secondary pressure is set to 6 bar Flow meter volume calibration must be performed as detailed in the Flow meter calibration section page 67 with the following additions e To calibrate the gas supply system and the Demand valve an extra calibration cycle has to be performed with the calibrating pump Inthis case the calibrating pump is harder to pull out and less flow speed is available due to the Demand valve s limited output Checking calibration results It is recommended to store calibration results as the tendency over time can help draw conclusions concerning device stability and possible aging Click the Store button to store calibration results Click the Print button to print calibration results Vie
121. oluntary ventilation garg Measurement goal The goal of the measurement is to get the amount of volume the patient can move in a given time _ zero ZERO Doctor Dr Semmelweis Ign c x 3 R E jn RSEN si S S E 3 a irome Wa Patients Setup Help 2007 08 02 12 00 45 TUV Uv Patients Maximum Voluntary Ventilation C IR BE BHSGNEZ BS LL Smith John 75kg 178cm iBTPS 27E C 999 EhPa 40 LLL leasure time 44 7 A UIT s v paella RE m PRE POST A LL Er Setup 1 o r Parameters Instructions pa diablia jE PARAM REF M 01 RSD a Ga Print j i zi PEMEX DI CU SN GEI UN AES MVV 144 54 si MVV f 77 60 a DONNE mum m 7 Full graph Display OnFly Analysis Single graph 245 He amp Side by side Frese ota Volume pem up m Piston Lung Function Test 86 Measurement modes Measurement process Instruct the patient to perform the following manoeuvres e Put on the nasal clip so he she can only breath through the nose e Move as much air as possible e The patient can choose the breath frequency as convenient e To prevent hypocapnia it is not recommended to continue this measurement for more than 15 seconds The patient has 60 seconds to perform MVV manoeuvre Push the Done button to stop the measurement Push the Discard button to delete the measurement
122. ometer the two nostrils resistance measurement may differ in time so before storing them in the database the two sides measurements must be paired The Rhinomanometer s measurement screen has a separate summary table for right and left nostril measurements The program automatically pairs the right and left nostril measurement pairs based on quality or measurement time Normal mode In case of a simple measurement it is recommended to sort the measurements based on airway resistance PRE POST In case of comparison measurement it is recommended to sort the measurements based on measurement time so the first right side measurement is paired with the first left side measurement Measurement selection Measurement management requires the selection of individual measurements e Click ona single point on a curve with the mouse button Or e Click on the line in the summary table belonging to the curve The selected curve appears on the graph with a dotted line the summary table s appropriate line is light blue Piston Lung Function Test 76 Measurements Measurement selection for storage Ao i e V All measurements are displayed in the measurement Ca Aw summary table Or Colour of serial number is identical to the colour of the O curve X X Ax 5 OX There are two icons next to their number a J O Re The first icon indicates the measurement s technical quality V The measurement
123. ow The customer or the user of the PRE 101 Ergospirometer should assure that it is used in such an environment IMMUNITY IEC 60601 Electromagnetic environment test test level level guidance Portable and mobile RF communications equipment should be used no closer to any part of the PRE 101 Ergospirometer including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vms 3 Vms IEC 61000 4 6 0 15 80 MHz 0 15 80 MHz d 1174 P Radiated RF 3 V m 3 V m IEC 61000 4 3 80MHz 80MHz 2 5GHz 2 5GHz d 117VP 80 MHzto 800 MHz d 2334P 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol t9 NOTE 1 At80 MHz and 800 MHz the higher frequency range applies NOTE2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular co
124. ple vaporizing head Vaporizing particle size sess 1 2 micron 9096 Maporizimg DOWOE 25 5 e dediti dleeie tetra s 0 12 g min Compressor DOWOL ode 5 scsi ascseesteasees 8 I s output 2 5 bar PDT 111 p Whole body Plethysmograph Flow measurement ratige dede tetteeteietens 15 l s Flow measurement accuracy eeeeeeeee 3 or 50 ml s Volume measurement Talige sco seine ide inside 151 Volume measurement accuracy eeeses 3 or 50 ml Pressure measurement range sese 10 kPa Pressure measurement accuracy sees 3 or 50 Pa Resistance measurement accuracy 3 or 50 Pa l s TLC RV volume measurement accuracy 5 or 100 ml Time measurement accuracy aeree coe denda oe re CE RUE 4 ms Recommended nr of breaths large time constant 20 40 min Recommended nr of breaths small time constant 60 120 min PDT 111 pd Diffusion capacity test Flow measurement range eost Ebr tecoetei feu rein 15 l s Flow measurement accuracy eeee 3 or 100 ml s Volume measurement range sss 151 Volume measurement accuracy sss 3 or 50 ml Gas concentration measurement accuracy seeeeeee 5 FRC RV volume measurement accuracy 5 or 100 ml Piston Lung Function Test 130 Technical data List of accessories Included a
125. ponsible of the Manufacturer Disposable accessories Bacterial and viral filter PBF 30SU The applied bacterial and viral filters are considered to be dangerous waste and must be handled according to valid laws Mouthpiece MPA 30 The applied mouthpieces are considered to be dangerous waste and must be handled according to valid laws Reusable accessories Rubber mouthpiece VM MP 2000 The rubber mouthpiece may be disinfected with a disinfecting solution made of cold water and appropriate chemicals for example Sekusept and may be reused after rinsing Piston Lung Function Test 31 Troubleshooting TROUBLESHOOTING Escape from the Plethysmograph cabin In case of malfunction of locking mechanism the cabin door may be N opened by removing the screws indicated on the following image The required Allen keys are included with the Plethysmograph cabin accessories In case of malfunction of locking mechanism the cabin door may be opened by removing the screws indicated p Allen key 3 I Allen key 4 Piston Lung Function Test 32 Troubleshooting Possible problems Spirometrics Problem Diagnosis Solution During quiet After several quiet breaths Set Zero again and repeat the breathing the have the patient remove the measurement Volume time curve drifts up or down mouthpiece The program continues to display the curve Watch the spirogram for at least 1
126. probe and lace its tubing thru the PinkFlow flow meter The plug of the Nasal probe has to face the patient side of the flow meter namely it has to be on the opposite side to the release button of the pneumatic quick connector Connect the tubing of the Nasal probe to the barbed fitting of the disc bacterial filter Warning When a tubing of the Nasal probe is laced thru the PinkFlow flow meter the sensitivity of the flow meter is modified This modification is automatically corrected in the Rhinomanometer mode Do not use the Nasal probe during any other measurement Only the Piston made Nasal probes can be used with the device The PinkFlow flow meter can be used only without bacterial and viral filter in Rhinomanometer mode consequently a clean PinkFlow flow meter has to be connected prior to each measurement Lace the plug of the Nasal probe thru the adapter of the facial mask and connect the PinkFlow flow meter to the adapter Piston Lung Function Test 13 Installation Facial mask maintenance The facial mask s pneumatic cushion may deflate with time For appropriate fitting the escaped air must be replaced Fill a LUER cone shaped syringe with air Fit the syringe into the facial mask valve opening push it in all the way to open the valve Push the air in Repeat the previous two steps until the facial mask is properly inflated Never over inflate as it will not properly fit the face PDD 301 s
127. program makes it possible to perform eight different measurements in all measurement modes All eight measurements data can be stored and reloaded later Forced exhalation and inhalation BaP Dl The most widely applied method for dynamic lung function test Detailed description may be found in the Measurement modes page 82 section In this operating mode the device measures the following parameters FVC Forced Vital Capacity Expired volume after full inspiration at the highest possible flow FEV 0 5 Forced Expiratory Volume 0 5 sec The amount of air exhaled in the first 0 5s during forced exhalation FEV 1 0 Forced Expiratory Volume 1 0 sec The amount of air exhaled in the first 1 0s during forced exhalation FEV 0 5 IVC The ratio of FEV 0 5 and the static vital capacity FEV 0 5 FVC The ratio of FEV 0 5 and the forced vital capacity FEV 1 0 IVC The ratio of FEV 1 0 and the static vital capacity FEV 1 0 FVC The ratio of FEV 1 0 and the forced vital capacity PEF Peak Expiratory Flow rate Highest flow during forced exhalation FEF 25 75 Forced mid Expiratory Flow rate The average volume flow speed calculated for the middle half of forced exhalation MEF 75 Forced Expiratory Flow at 75 lung volume Flow when 75 of the forced vital capacity is still in the lung MEF 50 Forced Expiratory Flow at 50 lung volume Flow when 50 of the forced vital capacity is still in the lung MEF 25 Forced Expiratory Flow at 25 lung volume
128. r Quadrat lt lt RC UI U DENT 1 os Parameters g Instructions 7 PRE POST la auia 3 PARAM REF M 01 RSD M 03 F Print pog mU NET DD 2 Or AN NEC ET idv NBC NN S ON QNARE RDUM MEI FVC 4 40 4 7 95 4 04 92 Ei j IVC 4 58 4 26 93 4 08 89 EN Exit FEV 0 5 2 72 2 77 y FEV 1 0 3 48 3 33 96 3 32 95 FEV 0 5 IVC 63 84 67 82 FEV 0 5 FVC 65 18 68 44 FEV 1 0 IVC 76 77 78 13 102 81 42 106 FEV 1 0 FVC 76 77 79 78 104 82 17 107 i PEF 8 59 10 41 121 9 06 106 4 2 8 8 FEF 25 75 3 66 3 13 86 000 0 Eu FEF 75 7 57 9 32 123 8 60 114 FEF 50 4 60 4 07 89 4 62 100 FEF 25 1 80 1 07 60 1 17 65 FET 5 74 6 06 MTT 0 95 0 59 62 5 01 529 FIVC 4 26 FIV 0 5 3 19 3 10 SM Gee QUEUE OU MU SE JR EHE cgo FIV 1 0 4 25 3 93 V Full graph Display PIF 4 2 7 24 OnE Anadis Rn d t FIF 25 75 7 09 4 75 d Volume Time Su SERNIIUNETORSIS a TE m os ENN OT OLDS NT RGB Ln VO E 8 i 6 1 H us H H H H 1 1 HERR H H 4 2 ma RET eni DB TR Pe a TT Measurement process Instruct the patient to perform the following manoeuvres e Put on the nasal clip so he she can only breath through the nose Take at least three quiet breathings Take as deep as possible inspiration Take as fast and deep as possible expiration Take as fast and deep as possible inspiration The patient has 60 second to perform the FVC manoeuvre Push the Done button to stop the measurement Push the Discard button to delete the measurement Pisto
129. r is not present optional characters are represented in the text as trailing blanks If a gt character appears in the mask all characters that follow are in uppercase until the end of the mask or until a character is encountered If a character appears in the mask all characters that follow are in lowercase until the end of the mask or until a character is encountered lt gt If these two characters appear together in a mask no case checking is done and the data is formatted with the case the user uses to enter the data The character that follows a character is a literal character Use this character to use any of the mask special characters as a literal in the data The L character requires an alphabetic character only in this position For the US this is A Z a z The 1 character permits only an alphabetic character in this position but doesn t require it The A character requires an alphanumeric character only in this position For the US this is A Z a z 0 9 The a character permits an alphanumeric character in this position but doesn t require it The C character requires an arbitrary character in this position The c character permits an arbitrary character in this position but doesn t require it The 0 character requires a numeric character only in this position The 9 character permits a numeric character in this position but doesn t require it The
130. radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the PDT 111 pd Whole body plethysmograph and Diffusion capacity test is used exceeds the applicable RF compliance level above the PDT 111 pd Whole body plethysmograph and Diffusion capacity test should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the PDT 111 pd Whole body plethysmograph and Diffusion capacity test 3 Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Piston Lung Function Test 138 EMC Guidance and manufacturer s declaration Recommended separation distances between portable and mobile RF communications equipment and the PDT 111 pd Whole body plethysmograph and Diffusion capacity test The PDT 111 pd Whole body plethysmograph and Diffusion capacity test is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the PDT 111 pd Whole body plethysmograph and Diffusion capacity test can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the PDT 111 pd Whole bod
131. ram does not store curves marked like this and they do not appear on the graph either z EITS RAAR ankar e Store active and questionable curves measurement and their parameters Mark all curves as active Mark the three best curves as active hide all other curves Effectively delete the selected curve Piston Lung Function Test 49 User interface List of Lung function Parameters Instructions PRE POST Warnings Setup Animation Miller Quadrant Report editor Print preview for lung function tests Print preview for compliance test Print preview for rhinomanometer Print preview for provocation test Print preview for audiometry Print preview for calibration Print selected measurement results Store a report as PDF document or image Close Report editor xrO0OW el HeJ ELR Piston Lung Function Test 50 User interface o gt i Ix Calibration Start calibration Skip specific phase during plethysmograph calibration continue from the next step Abort calibration Store measured results Print calibration report Piston Lung Function Test 51 User interface User interface general design The following image shows the general design of the measurement screens The individual measurement windows may differ from each other but the main controls are identical Device selector Zero setting Measure tine 1 Oy
132. rdless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the PRE 101 Ergospirometer is used exceeds the applicable RF compliance level above the PRE 101 Ergospirometer should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the PRE 101 Ergospirometer b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Piston Lung Function Test 146 EMC Guidance and manufacturer s declaration Recommended separation distances between portable and mobile RF communications equipment and the PRE 101 Ergospirometer The PRE 101 Ergospirometer is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the PRE 101 Ergospirometer can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the PRE 101 Ergospirometer as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter Rated maxim
133. ressure signal is seen the catheter 1 may need to be advanced further into the thoracic cavity or may be kinked on itself and needs to be withdrawn In the absence of diaphragmatic paralysis the pressure recorded should be negative on inspiration A positive inspiratory pressure recording may indicate gastric placement and the catheter 1 should be pulled back Pressures taken through the Y connector 2 are for balloon placement only The stylet luer cap and Y connector 2 are bonded into a single unit and must be removed from the catheter before taking pressure measurements for clinical purposes Once the catheter 1 has been positioned properly disconnect the extension tube 3 from the stylet Y connector 2 and remove the stylet assembly from the catheter Excessive curvature of the catheter may cause the stylet to bind in the catheter making removal difficult If the stylet binds in the catheter during removal instruct the patient to raise their head to straighten the catheter Pressure Data Acquisition After removing the stylet assembly 2 reattach the extension tube 3 to the luer of the catheter 1 and repeat steps 12 through 15 Radiographic placement of the balloon 81 is recommended to verify proper balloon placement When the catheter 1 is properly positioned it can be secured with tape to prevent extubation or movement Take pressure measurement Upon completion of the pressure measurements deflate the
134. ringispi PPF 18 PinkFlow Flow measirementT4lege es Serien ex en etra Ud Ep UR 18 I s Flow measurement accuracy eeeeee 3 or 50 ml s Volume measurement range sese 1851 Volume measurement accuracy eeeeee 3 or 50 ml PCD 702 Combo Device PlOW Meter oier eol ade icas eileen PPF 18 PinkFlow Total harmonic xdHstortIort o oet frr eis lt 1 Accuracy of frequency 22 2 dpa an etaed ital aided 1 For technical data of the ECG see the ECG s documentation PDD 301 r Rhinomanometer PLOW MICUCT PERMIT MN T RRE PPF 18 PinkFlow Pressure measurement range sse 2 kPa Pressure measurement accuracy sees 3 or 15 Pa Resistance measurement accuracy 3 or 30 Pa l s PDD 301 sco Breath CO monitor and spirometer Accuracy of CO measurement eee cece 2 or 2 ppm All other measurement parameters are the same as of the PDD 301 s spirometer PDD 301 rco Breath CO monitor and rhinomanometer Accuracy of CO measurement ssss 2 or 2 ppm All other measurement parameters are the same as of the PDD 301 r rhinomanometer Piston Lung Function Test 129 Technical data PDD 301 p Dose controlled drug nebulizer IS 1501 Green vaporizing head Vaporizing particle size eese 3 5 micron 9096 Vaporizing POWER Acidic eddy ede ee ee aiii o qs 0 3 g min IS 1503 Pur
135. rogram parts Maintenance safety backup related settings Reference value calculating algorithms List of parameters to be displayed Service panels Enter new doctor Modify doctor s data Store entered modified data Cancel changes a Er Er ki X O RET Accept changes and close Options panel Measurement windows Lung function test Start measurement in at FVC IVC MVV TGV TLC measurement Start gas mixture inhalation Close shutter for respiratoric pressure measurement Piston Lung Function Test 48 User interface h ah Start drug nebulization Do a solution after provocation test Measure left nostril resistance Measure right nostril resistance Start Resistance loop recording if the measurement already started and the patient breaths quietly Start Dynamic Compliance loop recording if the measurement already started and the patient breaths quietly Prepare Static Compliance loop recording if the measurement already started and the patient breaths quietly Start Static Compliance recording Finish measurement in case of successful measurement Abort measurement partial results are lost The measurement is technically correct The measurement is most likely technically incorrect The icon in the summary table indicates the active curves the specific measurement s curve is also displayed Indicates questionable curves The curves appear dashed The prog
136. rop down list whose data you would like to modify Click the Modify button Change the desired fields When done press the Save button You will see feedback about the success of the data storage If you do not wish to store the entered data press the Discard button About deleting To preserve consistency and for future searches it is not possible to delete from the database All diagnosis has traces in the database Language selection You can select the program s language in the Setup Options Operation menu item All supported languages are displayed in English and in the specific language as well Select the language you would like to use Patient identification format You can enter the patient identification format in the Setup Options Operation menu item Format descriptions may be found in the Appendix II page 172 section Graph settings Graph displays may be set in the Setup Options Display menu item Graph scheme You can select the graph color settings e Dark background bright lines e Bright background dark lines e Same as printed white background Raster The grid may be enabled or disabled on the graph Piston Lung Function Test 55 Settings Show curves It can be selected for several same type measurements e The diagrams appear in one coordinate system e All the diagrams appear in different coordinate systems Visible part of the curve For easier overview curve sectio
137. rtificate Registration No SX 60017406 0001 An audit was performed Report No 28202723 002 This Certificate is valid until 20 12 2011 Certification Body Akkreditiert durch Zentralstelle der L nder 3 f r Gesundheitsschutz EQ OX bei Arzneimitteln x a und Medizinprodukten yy R ZLG ZQ 995 00 01 46 Cologne 20 03 2007 Dipl Ing I Munkld Z erungs s T V Rheinland Product Safety GmbH Am Grauen Stein D 51105 K ln Tel 49 221 806 1371 Fax 49 221 806 3935 e mail cert validity de tuv com http www tuv com safety 10 020 12 060 Piston Lung Function Test 148 Certificates of Quality Management System APPROVAL T VRheinland EC Directive 93 42 EEC Annex V Article 3 Quality Assurance System Production Registration No DD 60017404 0001 Report No 28202723 002 Manufacturer Piston Kft Pihen u 1 C 1121 Budapest Hungary Scope Production and sales of audiometer and of lung diagnostic equipment and connecting single use mouth piece and bacteria filter Replaces Approval Registration No HD 2111265 01 Date of Expiry 20 12 2011 The Notified Body hereby authorizes the quality management system established and applied by the company mentioned above The requirements of Annex V Article 3 of the directive have been met This approval is subject to periodic surveillance defined by Annex V Article 4 of the aforementioned Noti
138. s Heated flow meter with stainless steel screen Hermetically sealed cabin USB computer connection Piston Lung Function Test 4 Introduction PDT 111 d Diffusion capacity measurement Measurement operating modes Forced inhalation and exhalation Static vital capacity Maximum voluntary ventilation Residual volume measurement Transfer factor measurement Design e Heated flow meter with stainless steel screen e Measurement gases CO and CH4 e USB computer connection PDT 111 pd Whole body plethysmograph and diffusion capacity test Measurement operating modes e The combined device s measurement operating modes are identical to the PDT 111 p and PDT 111 d devices measurement operating modes PDD 301 p Dose controlled drug nebulizer A medication nebulizer for the all above listed diagnostic devices which enables phramaco dynamic measurements Dosage distribution Respiration phase controlled vaporization Built in compressor USB computer connection PCD 702 Combo Device The Combo Device is technically equal to a fully functional PDD 301 s Spirometer a PDD 401 Audiometer plus an IMED Cardiax 12 channel ECG in a single housing Symbol annotation The following symbols indicate which descriptions apply to which device Spirometer Rhinomanometer Plethysmograph Diffusion capacity test Combo Device Spirometer Audiometer ECG Piston Lung Function Test 5 Introduction Technical overview L
139. second to perform the manoeuvres Push the Done button to stop the measurement Push the Discard button to delete the measurement 10 20 TC 30 40 50 s 60 Correct Breath CO measurement Phases Quiet breathing complete deep inspiration breath holding complete slow expiration Evaluation of the results The following evaluations are given by the system after the measurement Non Smoker High value for non smoker Smoker Frequent smoker Addicted smoker Heavily addicted smoker Dangerously addicted smoker Piston Lung Function Test 91 Measurement modes Thoracic Gas Volume Measurement goal The goal of the measurement is to get the mechanical parameters of the patient s respiratory system e Thoracic gas volume e Total lung capacity e Airway resistance and its components G r Doctor Dr Semmelweis Ign c xj mE a th Wa ee LN D OL EID Patients Setup Help 2007 08 02 12 04 23 edical TGV 33 Patients XL bees John 75kg 178cm BTPS 27 amp jC 999 hPa 40 5 lagnose i Measure time i 0 00 0 00 en pre post Warnings Gig Setup twat vsi Sort Parameters g Instructions calibration 5 i Ome S OReq PARAM REF M 01 RSD M amp 02 9e R 1 6 ive i 2 A Ive 4 58 5 07 111 5 07 111 aw 4r TLC 7 44 7 83 110 7 57 106 TGV 3 60 4 62 128 4 62 128 x Rhino m TE RV 2 38 2 76 116 2 50 105 TG
140. st 68 Calibration Plethysmograph calibration Diffusion capacity meter calibration is performed in the Spirometry Calibration menu In case of several connected devices select Plethysmograph from the Device selection list Plethysmograph calibration has to be started with the flow meter volume calibration The rest of calibration has to be performed with close cabin door Please close the cabin door After closing the cabin door you have to wait for complete thermal compensation which is 60s The automatic calibration process requires the following steps Check cabin leakage test During leakage test both cabin time constants are checked In this case the built in pump inflates the cabin to 15Pa pressure and discharge like curves indicating cabin leaking appear on the screen If the time constants deviate from the prescribed values the following error message appears on the screen Cabin leakage out of range In this case there is something wrong with the cabin tightness e Check that the cabin door is closed properly e Check that there is no foreign object between the cabin door and the sealing e Check that the cabin door sealing is intact Cabin pressure meter calibration In this case the built in sine pump creates a 15Pa pressure difference in the cabin The change in cabin pressure is visible on the screen If the cabin pressure meter calibration constant falls outside the 0 5 and 2 0 range the f
141. stalling the lung diagnostics devices the personnel must make sure the computer the monitor and the printer installed as medical electronic devices comply with the standards for the given country or the user declares concerning this with responsibility Minimum 1 5m SS Information exchange with the computer goes through USB connection For low leakage current relating to medical devices standards this connection is optically isolated inside the device Before shipping we check the device s leakage current The operator has the opportunity to have the leakage current checked periodically if he she finds it necessary The system must be installed so the examined person is at least 1 5m away from those devices that are electrically connected to the computer equipment Parts of the system computer monitor printer can only be replaced in case of failure modification or for any other reason if the part to be installed has the same electric shock protection conditions as the original one The personnel installing the device will train the operator concerning operation electric shock protection This training includes the contents of this section The operator verifies the training in official written form Piston Lung Function Test 8 Installation Minimum PC configuration The operation of the lung diagnostics system requires a personal computer with the following minimum configuration Description
142. surement summary table e The gas sampling marker appears on the spirogram e Use the arrows on the gas concentration panel to move the marker left and right e Use the methane CH4 curve blue graph to find the optimal marker position where the curve is almost horizontal but is close enough to the curve inflexion point e When manually setting the marker you have to be careful because it significantly affects the measurement results Gas Marker concentration panel CH4 0 2147 co 0 1023 C02 5 3136 WOV 2 6771 iid Dr Correct Diffusion capacity measurement Phases quiet breathing complete deep expiration even gas mixture inspiration breath holding even expiration during gas sampling Incorrect marker positions The marker is too much to the left at the The marker is too much to the beginning of the expiration curve right at the end of the expiration curve Piston Lung Function Test 100 Measurement modes Intra Breath Diffusion capacity test An alternative method for diffusion capacity measurement for the poorly cooperating patients who are unable for the breath holding manoeuvre Measurement goal The primary goal of the measurement is to get the oxygen binding capacity of the patient s lung Transfer factor calculated for carbon monoxide Functional residual capacity Total lung capacity Residual lung capacity IMPORTANT N There must be at least 5 minutes
143. t in 2 seconds Calibration time interval You can set how often the device should remind you of the need for calibration Plethysmograph P Select the Plethysmograph group in the Setup Options Devices menu The following device operation related settings are available Enable Metronome You can turn the light and sound signal of metronome on or off Low breathing rate The plethysmograph cabin has two selectable leakage time constants Low breath frequency means less stress for the patient but thermal compensation takes longer High breathing rate High breath frequency means more stress for the patient but thermal compensation happens sooner AutoBTPS If enabled resistance loops are automatically closed Efficiency of BTPS If AutoBTPS option is off this is where you can set the theoretical lung model BTPS correction effectiveness Default value 4596 Balance time This is where you can set the waiting time after closing the cabin s door to the beginning of the very first TGV measurement in order to reach the adequate thermal balance in the cabin Number of Resistance loops This is where you can set the number of Resistance loops the device should record in one measurement Piston Lung Function Test 58 Settings Number of TGV loops This is where you can set the number of breaths the shutter should close Barometer calibration It is possible to exactly set the barometer measuring environmental pressure
144. tage variations on power supply input lines IEC 61000 4 11 5 Ur gt 95 96 dip in U for 0 5 cycle 40 Ur 60 96 dip in U7 for 5 cycles 70 Ur 30 96 dip in U7 for 25 cycles 5 Uy gt 95 dip in Ux for5s 5 Ur gt 95 dip in Ux for 0 5 cycle 40 Ur 60 dip in U7 for 5 cycles 70 Ur 30 dip in U7 for 25 cycles Not applicable Mains power quality should be that of a typical commercial or hospital environment If the user of the PDT 111 pd Whole body plethysmograph and Diffusion capacity test requires continued operation during power mains interruptions it is recommended that the PDT 111 pd Whole body plethysmograph and Diffusion capacity test be powered from an uninterruptible power supply or a battery Power frequency 50 60 Hz magnetic field IEC 61000 4 8 Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE Uris the a c mains voltage prior to application of the test level Piston Lung Function Test 137 EMC Guidance and manufacturer s declaration Guidance and manufacturer s declaration electromagnetic immunity The PDT 111 pd Whole body plethysmograph and Diffusion capacity test is intended for use in the electromagnetic environment specified below The customer or the user of the PDT 111 pd Whole body plethysmograph and Diffusion capacity test shou
145. tal status If you have any member of the PDT 111 device family the device automatically measures the environmental data necessary for BTPS correction air pressure e temperature e humidity You can select in the Setup Options Operation Source of environment info menu which device s environmental data the system should use e USB diffusion e USB Plethysmograph e Automatic In case of automatic option e The device calculates with the environment data measured in the cabin during Resistance and TGV measurement e During all other lung function test the system uses the environment data measured by the diffusion capacity meter outside the cabin Calibration Syrigne Baro You can set the calibrating pump volume at the Setup Options Devices Calibration Syringe menu Number of calibrating cycles Boe The number of calibrating cycles with the calibration pump may be set in the Setup Options Devices Calibration Syringe menu e Minimum 2 e Maximum 20 e Recommended 10 Piston Lung Function Test 57 Settings Spirometer E Select the Spirometer group in the Setup Options Devices menu The system senses the spirometer connection to the USB port in 2 seconds Calibration time interval You can set how often the device should remind you of the need for calibration Rhinomanometer Li Select the Rhinomanometer group in the Setup Options Devices menu The system senses the rhinomanometer connection to the USB por
146. ter 3rd Parameter scrolling down list Enter the tolerance limit for each parameter in to the filed When any of these limits is reached during the provocation sequence the system gives a warning Piston Lung Function Test 117 Measurement modes Basic measure The basic measurement should be performed prior to any inhalation from the provocation or bronchial diluting agent All the following results will be compared to this basic measurement To start a lung function test click on the Meas button The measuring window of the previously selected mode opens Perform a few measurements and the Provocation test module selects the best measurement automatically and this will be taken as a Basic measurement as well After finishing click on the Provocation button at the Spirometry main menu and the Provocation test window reappears Results of the lung function test are stored automatically Drug nebulising In the case of Fix concentration and Dilution queue Dose mode give the actual dosage to be inhale in the Amount of agent field a click on the Prov button Or In the case of Dilution queue 2 minute mode click on the Prov button Patient has to inhale evenly from the nebuliser The nebulising will be stopped automatically when any of the following conditions is fulfilled e The patient inhales the actual dosage Fix concentration Dilution queue Dose e The total quantity of the inhaled agent reaches the
147. the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Piston Lung Function Test 135 EMC Guidance and manufacturer s declaration Guidance and manufacturer s declaration electromagnetic emissions The PDT 111 pd Whole body plethysmograph and Diffusion capacity test is intended for use in the electromagnetic environment specified below The customer or the user of the PDT 111 pd Whole body plethysmograph and Diffusion capacity test should assure that itis used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions Class B IEC 61000 3 2 Voltage fluctuations flicker emissions Complies IEC 61000 3 3 The PDT 111 pd Whole body plethysmograph and Diffusion capacity test uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment The PDT 111 pd Whole body plethysmograph and Diffusion capacity test is suitable for use in all establishments including domestic establishments and those dire
148. tient circuit 0 eeeeeeeeereecneeeeneeteees 19 PDT 111 p and PDT 111 pd Cabin placement eese 20 PDT 111 pd Plethysmograph and diffusion capacity test installation 21 Connecting the gas cylinder to the PDT 111 pd sess 24 SOLLWare installation oie uio p RES st EN DAN Ed tans ato Qui en ve UR Mod Ee 26 hy rirdir riw CDU DU EE 30 Device Traite TANCE oed sere aee he ax nde Ye Rp oper oe seo Qr ae S cete p ues 30 Blow meter maintenance 4252 ette eh pae aab Seu eoe ae a ELM ee aet Te ease bo Eee eue 30 Breath CO monitor maintenance sve sis eene eye ct e eb ete dotes Gee an Pn e PERDE Ra lde 31 Disposable accessOnmes sii canadien anaiedasndunaiinamlvuianaiand 31 Reusable accessories sna nn raionet eee neds Docs be suhag sueet cade e as 31 Troubleshooting nie vicecascnssnissnsenssssadaset cs vesuestiasbaieniessncttsidasabecvonisasiasisdens 32 Escape from the Plethysmograph cabin eene 32 Possible problems ice uero as Ua e R R a 33 The program s main functions e c e eere ee ee eee eerte eee eo sette seta seen aae 36 Available Gx amimatiOns EE 36 System comparison tables ny ieuo patiente feta soon NE EH A geo inn 45 User INMGETTACE Loose erata isse vt err entrer ten ev niae bata eu Y DDR eee aon dod 46 o T 46 User interface general design eret etienne e esatta eee uo pede Rus 52 SOEIEROS aide UP e OR INDE A WOMEN IE T DIRE UMS 54
149. ton Lung Function Test 152 EC Declaration of Conformity PISTON Ltd Tel 36 1 275 0033 1121 Budapest Fax 36 1 275 0034 Pihen u 1 C pavilon http www pistonmedical com HUNGARY Email info pistonmedical com EC DECLARATION OF CONFORMITY MANUFACTURER Piston Ltd Hungary H 1121 Budapest Pihen u 1 c PRODUCT Rhinomanometer and Spirometer IBM PC based MODEL NUMBER PDD 301 r CLASSIFICATION Class lla Council Directive 93 42 EEC of MDD Annex V Article 3 DECLARATION We herewith declare that the above mentioned products meet the provision of the Council Directive 93 42 EEC for medical devices All supporting documentation is retained under the premises of the manufacturer STANDARDS APPLIED EN 60601 1 EN 60601 1 2 EN 30993 1 EN 980 EN 1441 NOTIFIED BODY T V Rheinland Product Safety GmbH Germany D 51105 K ln Am Garuen Stein EC CERTIFICATES ISO 13485 2003 Registration Nr SX 600174060001 Report Nr 28202723002 CE 0197 Registration Nr HD 2111265 01 Report Nr C 2192133 E 01 MAIN ACCESSORIES PCS 3000 Calibration syringe PBF 30 Bacterial filter MPA 30 Mouth piece BUDAPEST 11 May 2007 EAE Mr efe Quality Assurance Manag r lt Piston Lung Function Test 153 EC Declaration of Conformity PISTON Ltd 1121 Budapest Pihen u 1 C pavilon HUNGARY Tel 36 1 275 0033 Fax 36 1 275 0034 http www pistonmedical com Email
150. tt edae idet order Meca te brio da Dates etd TES 169 Sweden National Hedenstr m Malmberg 1985 usse 170 Finnish National Viljanen 1981 gists aos te oiecanteas deca dee eet eure xp eee 171 PRG Prem qii eoe 172 Format of the patient identification field sse 172 Piston Lung Function Test 3 Introduction Devices INTRODUCTION Piston Ltd s respiratory diagnostics product family contains the following members PDD 301 s Spirometer Measurement operating modes Design Forced inspiration and expiration Static vital capacity Maximum voluntary ventilation Flow meter PPF 18 PinkFlow symmetric Pitot tube USB computer connection Portable design PDD 301 r Rhinomanometer and Spirometer Measurement operating modes Design Forced inhalation and exhalation Static vital capacity Maximum voluntary ventilation Nasal respiratory resistance measurement with active anterior and posterior methods Flow meter PPF 18 PinkFlow symmetric Pitot tube USB computer connection Portable design PDT 111 p Whole body plethysmograph Measurement operating modes Design Forced inhalation and exhalation Static vital capacity Maximum voluntary ventilation Thoracic gas volume measurement Residual volume measurement Respiratory resistance measurement Respiration work measurement Nasal respiratory resistance measurement with active anterior and posterior method
151. tted a warning appears Results of the lung function test are stored automatically After a lung function test a new nebulising should be performed These cycles should be repeated till the desired effect reached If you wish to make a lung function test again in stead of nebulising a warning appears The last maneuver was also measuring Before another measure you may do a nebulization Do you really want to do another measurement instead If any of the selected parameters reaches the previously given limit a message appears Provocation successful list of parameters Suspending the sequence If the reaction time of an agent is too long and there is a need to free the system for other functions the sequence can be suspended at any time Click on the Store button and close the Provocation window Resuming the sequence e Search and retrieve the patient from the database Patient database page 62 e Search and retrieve the measurement to be continued from the database most likely it would be the last one e Select a Provocation test e Reload the selected measurement The a Provocation test can be resumed at the next cycle Piston Lung Function Test 119 Measurement modes Bronchial dilution It is strongly recommended to perform a bronchial dilution after each provocation test in order to prevent the patient from the unexpected effects of the provocation Closing the Provocation test a warning
152. tter open option the inhaled volume limit value during breath holding cannot exceed 200 ml Calibration interval You can set how often the device should remind you of the necessity to calibrate Piston Lung Function Test 61 Patient database PATIENT DATABASE User interface overview Main window Doctor Dr Semmelweis Ign c Ej O amp A 2007 08 02 12 33 02 Setup Help minm Sh Ill patient C1 Only patients with existing measure Lodi pl RT Detailed search Quick search Postal address Born Mother s name weight Height ID 1121 Budapest Pihend steet JC 1969 07 20 5 dU 105336024 2092 Budakeszi Erkel Ferenc us 27a 1981 01 00 Fly Katalin 5 T 037984915 1121 Budapest Pihend t 1 C 2006 05 05 Agatha Christe T6 178 000000000 Patient list CLE ERN NN NN 3 NN Details IC 426 FVC 417 Details Control panel Visits 5 17 TLC 26 44 Tico Measurements Load Measurement selection Quick search Helps find a patient Patient list A list of patients meeting the search criteria Details Displays the selected patient s most important parameters for the selected measurement Control panel Basic database operations enter new patient modify patient data store Visits Dates of previous visits Measurements A list of measurements for the selected date or measurement type Piston Lung Function Test 62 Patient
153. um m output power of transmitter 150 kHz 80 MHz 80 MHz 800 MHz 800 MHz 2 5 GHz d 117VP d 117VP d 2 334 P 0 12 0 12 0 24 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Piston Lung Function Test 147 Certificates of Quality Management System CERTIFICATES OF QUALITY MANAGEMENT SYSTEM T VRheinland Certificate 3 The Certification Body of TUV Rheinland Product Safety GmbH hereby certifies that the organization Piston Kft Pihen u 1 C 1121 Budapest Hungary has established and applies a quality management system for medical devices for the following scope Production and sales of audiometer and of lung diagnostic equipment and connecting single use mouth piece and bacteria filter Proof has been furnished that the requirements specified in EN ISO 13485 2003 are fulfilled The quality management system is subject to yearly surveillance Ce
154. ung diagnostic device family main parts description Flow meter PDD 301 s PDD 301 r ISTRISA J PPF 18 PinkFlow symmetric Pitot tube flow meter which provides pressure difference in proportion with the flow speed A differentiate pressure sensor converts the pressure difference to electric signal Patient circuit PDT 111 p gi The patient circuit ensures device to patient connection and contains the following parts e Lilly type heated screen flow sensor e Shutter magnetic valve e Metronome Patient circuit PDT 111 d and PDT 111 pd DI The patient circuit ensures device to patient connection and contains the following parts e Lilly type heated screen flow sensor e Shutter magnetic valve Metronome Demand valve e Gas sampling line Plethysmograph cabin PDT 111 p and PDT 111 pd E The closed cabin makes it possible to measure alveolar pressure by non invasive method through two transfers e The cabin has two types of leakage time constants user selectable depending on measurement method e The cabin door can only be locked from the out from the inside it can only be opened e Incase of locking mechanism malfunction the cabin can be opened from the outside by undoing a few screws Piston Lung Function Test 6 Introduction Gas supplying system PDT 111 d and PDT 111 pd D To determine diffusion capacity the patient must inhale an air mixture containing CO 0 3 and CH4 0 3 gases Parts of the gas supplyi
155. utput power of the communications equipment Separation distance according to frequency of transmitter Rated maximum m output power of transmitter 150 kHz 80 MHz 80 MHz 800 MHz 800 MHz 2 5 GHz w d 1 1 714P d 117VP d 2 334 P 0 12 0 12 0 24 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Piston Lung Function Test 143 EMC Guidance and manufacturer s declaration Guidance and manufacturer s declaration electromagnetic emissions The PRE 101 Ergospirometer is intended for use in the electromagnetic environment specified below The customer or the user of the PRE 101 Ergospirometer should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance The PRE 101 Ergospirometer uses RF RF emissions energy only for its internal function Group 1 Therefore its RF emissions are very low and CISPR 11 are not likel
156. veral criteria When those criteria change the program automatically lists the patients meeting the updated criteria Normal search Search only based on the patient s family and surname Enter the patient s name or part of it Detailed search Click the Detailed search button You can refine the search criteria in the window patient s sex date of birth with interval address or part of it doctor identifier social security number Viewing previous measurements All previous measurements can be reloaded so reports can be printed at anytime Viewing previous measurements To reload previous measurements e Select the patient e Select the visit by date e If you only wish to view the results of certain measurement mode select the one from the list e Select required measurements If you wish to see all measurement results of a selected visit click the Open button If only certain measurements are important click them while holding the CTRL button down After selection click on the Open button If you wish to include further measurements to the report click the Patient database button to reopen the Patient database Select further measurements and click the Add measure button to include them to the report WARNING You can only simultaneously load eight measurements of the same mode For this reason the Load all button is not always available Piston Lung Function Test 65 Patient database
157. wing previous calibration data Select the Result tab on the calibration window Information panel You can search for previous calibration results from the Reload calibration data time sorted list Piston Lung Function Test 70 Measurements MEASUREMENTS General measurement process daily routine BP D Calibration if necessary YES Enter into the database New patient NO Search from the database Load previous measurements if necessary Reset if necessary Enter BTPS data RHINO Le measure measure measure measure measure measure Measurement evaluation Enter diagnosis Measurement done NO YES Store measurement Print measurement YES Close program Piston Lung Function Test 71 Measurements Patient selection Before starting the measurement it is necessary to enter patient data using one of the following methods e Enter new patient e Search for patient already in the database Preparations STR D Device Connection Make sure that the device you wish to use is connected to the computer If not connect the device as detailed in the Installation 8 page section Selection Select the device you wish to use from the Device selection list because basic lung function tests FVC IVC MVV can be performed with any of the devices Patient circuit To prevent cross contamination a new disposable bacterial and viral fi
158. y normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the PDD 301 r Rhinomanometer P Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Piston Lung Function Test 134 EMC Guidance and manufacturer s declaration Recommended separation distances between portable and mobile RF communications equipment and the PDD 301 r Rhinomanometer The PDD 301 r Rhinomanometer particular implementation PDD 301 s Spirometer is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of PDD 301 r Rhinomanometer can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the PDD 301 r Rhinomanometer as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter Rated maximum m output power of transmitter 150 kHz 80 MHz 80 MHz 800 MHz 800 MHz 2 5 GHz W d 117VP d 117VP ZIAN 0 01 0 12 0 12 0 24 0 1 0 37 0 37 0 74 2 33 7 38 100 11 7 11 7 23 33 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is
159. y plethysmograph and Diffusion capacity test as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter m Rated maximum output power of transmitter 150 kHz 80 MHz 80 MHz 800 MHz 800 MHz 2 5 GHz W d 117VP d 117VP d 2 33VP 0 24 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 7 3 7 7 38 23 33 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE1 At80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Piston Lung Function Test 139 EMC Guidance and manufacturer s declaration Guidance and manufacturer s declaration electromagnetic emissions The PDD 301 p drug nebuliser is intended for use in the electromagnetic environment specified below The customer or the user of the PDD 301 p drug nebuliser should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance The PDD 301 p drug nebulis
160. y to cause any interference in nearby electronic equipment RF emissions Class B CISPR 11 The PRE 101 Ergospirometer is suitable for Harmonic emissions use in all establishments other than domestic Class A and those directly connected to the public IEC 61000 3 2 low voltage power supply network that supplies buildings used for domestic Voltage fluctuation s purposes flicker emissions Complies IEC 61000 3 3 Piston Lung Function Test 144 EMC Guidance and manufacturer s declaration Guidance and manufacturer s declaration electromagnetic immunity The PRE 101 Ergospirometer is intended for use in the electromagnetic environment specified below The customer or the user of the PRE 101 Ergospirometer should assure that it is used in such an environment IMMUNITY IEC 60601 Compliance Electromagnetic test test level Level environment guidance Floors should be wood Electrostatic concrete or ceramic tile If discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 1 1 6 kV contact X 8kV air t2kV for power supply lines 1kV for input output lines 1 kV line s to line s 2 kV line s to earth 5 Ur gt 95 96 dip in U7 for 0 5 cycle 40 Ur 60 96 dip in U for 5 cycles 70 96 Ur 30 dip in U7 for 25
161. you can set the individual values manually Comlex curves The more complex curves of the individual measurement operating modes For example in case of FVC measurement the flow volume loops in case of Plethysmograph measurement Resistance and TGV loops Graph settings This is where you can set graph display modes These settings are also available on the Options panel details may be found in the Graph settings page 55 section Control This filed contains the basic control functions during the measurement The appropriate Function buttons are shown in square brackets Start measurement F3 Start special measurement section F4 Finish measurement after a successful measurement F5 Stop measurement abort measurement for example in case of malfunction ESC e Store print Spirogram Volume time graph which monitors the patient s breathing during the measurement Information panel This section contains information settings functions Current measurement parameter list PRE POST settings and parameters Measurement related warnings error messages Measurement instructions Piston Lung Function Test 53 Settings SETTINGS The Setup Options menu item allows customization of the system Settings that can be changed during measurement are also available in the Setup tab of the measurement windows Program settings appear grouped on the left side ey Institute setup 4 Plethysmograph 29

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