TABLE OF CONTENTS... 1

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1 Table of Contents TABLE OF CONTENTS... 1 QUICK PREVIEW... 5 INSTALLATIONS... 5 DAILY ROUTINE... 6 PROVOCATION TEST... 7 ICON DESCRIPTIONS... 9 BIRTHDAY CAKE ANIMATION CALIBRATION ANIMATION ZERO SETTING ANIMATION SCREEN INTRODUCTION SYSTEM CHART INSTALLATION AND CONFIGURATION INSTALLATION OF PDD-301/S SPIROMETER INSTALLATION OF PDD 301/R RHINOMANOMETER INSTALLATION OF PDD 301/P DRUG NEBULIZER MINIMUM PC CONFIGURATION SOFTWARE INSTALLATION CONFIGURING THE PROGRAM CONFIGURATION OF DRUG NEBULIZER EXIT MEASUREMENT MODES FORCED EXPIRATION AND INSPIRATION STATIC VITAL CAPACITY MAXIMAL VOLUNTARY VENTILATION RHINOMANOMETER CALIBRATION CALIBRATING THE FLOW SENSOR MEASUREMENT ZERO SETTING MEASUREMENT OF FORCED VITAL CAPACITY VITAL CAPACITY MEASUREMENT MAXIMAL VOLUNTARY VENTILATION ALLOWING / DISALLOWING THE BIRTHDAY CAKE GRAPH GRID ON / OFF Table of Contents - 1

2 ENTERING BTPS DATA UNIT SELECTION PREDICTED-VALUE CALCULATION THE RESULT TABLE COMMENT SAVE RESULTS COMMENT EXPORT DATA TO EXCEL RHINOMANOMETER ZERO SETTING ANTERIOR MEASUREMENT POSTERIOR MEASUREMENT PROVOCATION TEST GRAPH SELECTION THE RESULT TABLE COMMENT SAVE RESULTS COMMENT EXPORT DATA TO EXCEL DRUG NEBULIZER SAFETY PRECAUTIONS SET-UP OF PROVOCATION TEST Agent selection Test mode selection Test type selection Diluting queue Constant concentration Nebulizer pot selection Material of solution PARAMETER SELECTION DRUG NEBULIZING PRINTING COMMENT EXPORT DATA TO EXCEL MEASUREMENT ANALYSIS ANALYSING FORCED VITAL CAPACITY ANALYSING VITAL CAPACITY ANALYSING HYPERVENTILATION ANALYSING RHINOMANOMETRY REPORT REPORT PREVIEW REPORT PRINT REPORT CONTENTS REPORT CONTENTS OF THE RHINOMANOMETRY Table of Contents

3 MAINTENANCE BACTERIAL FILTER MOUTHPIECE DISINFECTING THE FLOW SENSOR NOSE PLUG (RHINOMANOMETER) FACIAL MASK (RHINOMANOMETER) CLEANING OF MISCELLANEOUS PARTS SUMMARY TABLE OF CLEANING AND DISINFECTING POSSIBLE PROBLEMS AND SOLUTIONS CONTROL PROBLEMS INDIVIDUAL ERRORS TECHNICAL SPECIFICATIONS WARRANTY LIMITED RESPONSIBILITY SAFETY PRECAUTIONS ENVIRONMENTAL CONDITIONS ELECTRICAL SAFETY ELECTRICAL SPECIFICATION MECHANICAL DATA GENERAL PARAMETERS GUARANTEED VALUES ACCESSORIES APPENDIX EUROPEAN COAL AND STEEL KNUDSON COTTON DUST STANDARD CRAPO-HSU AUSTRIAN Table of Contents - 3

4 4 - Table of Contents

5 Quick Preview Installations Connecting the device See pages Hiba! A könyvjelző nem Software installation * See Users Manual of Database Start panel * See Users Manual of Database Location of the database * See Users Manual of Database Physicians data * See Users Manual of Database Data of Institution * See Users Manual of Database Configuration of the device See page Hiba! A könyvjelző nem Creation and Selection of a Database * See Users Manual of Database *Marked items can be used only in Database version Quick Preview - 5

6 Daily Routine Run the program Open Database * See Users Manual of Database Enter to the Database * See Users Manual of Database Yes New patient? No Retrieval from the database * See Users Manual of Database Predicted-value Algorithm Selection See pages: 43 Zero setting See pages: 37 Entering BTPS data See pages: 41 Calibration See pages: 34 FVC Measure See page: 38 VC measure See page: 39 MVV measure See page: 40 Rhinomanometry See page: 45 Entering Diagnosis See page: 43 Comment See pages: 44 Print report See pages: 63 Save results See pages: 44 No Finished? Yes Close Patients Window Exit Program *Marked items can be used only in Database version 6 - Quick Preview

7 Provocation test Set Parameters of Provocation Test See pages: 51 Lung function test See pages: 37 Provocation See pages: 54 No Finish? Yes Dilution of Airways Lung function test Entering Comment Print report See pages: 56 Save results of Provocation Test Quick Preview - 7

8 Provocation test 8 - Quick Preview

9 Icon Descriptions Lung function test Forced expiration and inspiration Static vital capacity Hyperventilation Return from the Lung function test submenu Rhinomanometer Drug aerosol Printing Exit Zero setting Icon Descriptions - 9

10 Calibration Start first measurement Start second measurement Start third measurement Stop Zoom Allow / disallow birthday cake Results of the first measurement into the report Results of the second measurement into the report Results of the third measurement into the report Table of pre / post or current result 10 - Icon Descriptions

11 Turn graph grid on / off Save results Comment Export data to the Excel Measure / Provocation mode Abort provocation test Left side resistance Anterior Right side resistance Anterior Posterior resistance Rhinomanometer Provocation View current and previous comments Step back in print preview Icon Descriptions - 11

12 Step forward in print preview Full page view in print preview Two page view in print preview Exit from print preview Birthday cake animation Calibration animation Zero setting animation 12 - Icon Descriptions

13 Screen Icon Descriptions - 13

14 14 - Icon Descriptions

15 Introduction The PDD-301 is a PC based lung function testing equipment family. There are two software versions of the system, the so-called module version and the database version and module version. The database version provides archivation and retrieval of parameters and results. The module version can be integrated into the frame system, which provides the archivation and retrieval of parameters and results. In this case the spirometer program provides only the measurement and calculation of parameters. The equipment provides the most important lung function testing further more the measurement of airway resistance of nasal canal. It can be used in the practice of general practitioners, NOT specialists and in labour medicine. Thanks to the PC based system, the handling of the equipment is very easy and simply, but at the same time it provides a lot of features. The software is Windows based. The curves of breathing are shown on the screen real time and after completion of the test the values of calculated parameters are displayed. Results can be printed out as well. The PDD-301/s Spirometer provides the following measurements: Forced ex- and inspiration Static vital capacity Maximal Voluntary Ventilation Pharmaco dynamic test The PDD-301/r Rhinomanometer provides additionally to the Spirometer the following measurements: Anterior Left side resistance Anterior Right side resistance Posterior resistance Introduction - 15

16 System chart System chart The basic unit of the equipment family is the Spirometer, which can be extended with the following modules: Rhinaomanometer PDD-301/r Dose controlled - PDD-301/p The system calculates from the patient s antropometric data the predicted values of the parameters. Further more the system calculates the percentage of measured values and the predicted values helps in making diagnose on the base of residual standard deviation. The measurements of the system, the definitions and names of parameters and the graphs displayed comply with the requirements of the Standardised Lung Function Testing by European Community for Coal and Steel and Standardisation of Spirometry by the American Thoracic Society. Devices in this Manual are modular. Below the name of devices the measurement modes are listed: PDD-301/s Spirometer Forced ex- and inspiration Static vital capacy Maximal Voluntary Ventilation PDD-301/r Rhinomanometer and spirometer Anterior Left Anterior Right Posterior PDD-301/p Drug Nebulizer Provocation test Pharmaco-dynamic test 16 - Introduction

17 Installation and Configuration The safety precautions in this chapter must be followed! The authorised distributors or their authorised staff may only install the PDD-301 system. The above mentioned companies only accept liability for their installations. Before operating the PDD-301 system, the user has to make sure that the computer and monitor to be used as medical electronic device has license for office use, issued by local authorities or the user declares full responsibility for safety. The installation should be done in a way that the patient was at least 1.5 m distance from all the devices, which are in direct electric contact with the PC. In case of faulty equipment, design modification or any other reason the devices in the system (computer, monitor, printer) may only be exchanged, if the new device(s) has the same safety class as the original device, and the sign mentioned above is also applied to the new device(s). The user has to be instructed about the safety precautions by the person performing the installation. This instruction also includes the review of this chapter. The user certifies the performance of this instruction in writing. Installation and Configuration - 17

18 Installation of PDD-301/s Spirometer 18 - Installation and Configuration

19 Serial interface Connect the serial cable to the spirometer and to a free RS-232 serial port of the PC. USB interface Connect the USB cable to the spirometer and to a free USB port of the PC. Connect the end of the pneumatic twin tube with the patient pictogram to the flow meter. Turn the CPC pneumatic connector clockwise till clicks. Conect the end of the pneumatic twin tube without any sign to the spirometer interface. Turn the CPC pneumatic connector clockwise till clicks. The patient pictogram on the twin tube shows the side of the flow meter where to push the bacterial filter. Usage of bacterial filter is compulsory. The single use mouthpiece should be pushed on the bacterial filter. - 19

20 Installation of PDD 301/r Rhinomanometer Serial interface Connect the serial cable to the spirometer and to a free RS-232 serial port of the PC. USB interface Connect the USB cable to the spirometer and to a free USB port of the PC. Connect the end of the pneumatic twin tube with the patient pictogram to the flow meter. Turn the CPC pneumatic connector clockwise till clicks. Connect the end of the pneumatic twin tube without any sign to the rhinomanometer interface. Turn the CPC pneumatic connector clockwise till clicks. Connect the pressure tube to the pressure port of the rhinomanometer interface. Turn the CPC pneumatic connector clockwise till clicks. The disk filter on the pressure tube should be changed after 100 hours of usage. Connect the single use nose plug to the adapter Hiba! A hivatkozási forrás nem található.

21 Push the adapter into the pneumatic connector of the facemask. The patient pictogram on the twin tube shows the side of the flow meter where to push the bacterial filter. Usage of bacterial filter is compulsory. Plug the flow meter with bacterial filter to the adapter. Installation of PDD 301/p Drug nebulizer Connect the 15-pin cable to the DIAGNOSTIC PERIPHERIALS port of the spirometer or rhinomanometer. Connect the 15-pin cable to the FROM SPIROMETER port of the Drug nebulizer. Installation and Configuration - 21

22 The assemble of the patient circuit shown on the figure: Parts shown on the figure: IS-1944 Bacterial and viral filter IS-1920 One-way valve IS-1984 T-connector with pressure port PRT-24 Mouth pressure filter adapter VM-3434 Mouth pressure bacterial and viral filter IS-1982 T-connector IS-1174 High pressure tube IS-1573 Corrugated tube IS-1930 Mouthpiece IS-1501 Nebulizer pot - green 3.5 micron IS-1503 Nebulizer pot violet 1.2 micron When ordering spare parts please indicate the part number as well Hiba! A hivatkozási forrás nem található.

23 Installation of PDD 301/p Drug nebulizer Pay attention to the direction of one-way valves. The conical connectors should be pushed tightly enough for the proper sealing. Place one one-way valve into the T connector without pressure port. Place the other one-way valve into the T connector with pressure port. Push the corrugated tube onto the T connector with pressure port. Push the mouthpiece into the corrugated tube. Push the T connector without pressure port into the holder. Installation and Configuration - 23

24 Installation of PDD 301/p Drug nebulizer Push into the holder the other T connector. Place at the expiration end the bacterial and viral filter. The filter prevents environment from the exhaled medicaments. Insert the desired nebulizer pot. Connect the high-pressure tube to the nebulizer pot. Connect the high-pressure tube to the port Output pressure at the device Installation and Configuration

25 Installation of PDD 301/p Drug nebulizer Connect the mouth pressure tube to the pressure port of the T connector. The filter disk protects the device itself. Connect the mouth pressure tube to the port MOUTH PRESSURE at the device. The CPC pneumatic connector should be turned clockwise till clicks. Place the bacterial sand viral filter to the intake port of the compressor. This filter protects the compressor and the tubing. Change the filters after 100 hours of service. Hiba! A(z) Bekezdés alap-betűtípusa itt megjelenítendő szövegre történő alkalmazásához használja a Kezdőlap lapot.installation and Configuration - 25

26 Minimum PC configuration Serial interface The following minimum configuration is required to run the program: Pentium MB RAM Colour monitor with 800x600 resolution and 256 colour and VGA video card 10 MB free space on the hard disk drive Windows compatible printer Mouse 1 free serial port Windows 3.1, Window 9x, Windows XP USB interface The following minimum configuration is required to run the program: Intel or AMD processor 1 GHz 256 MB RAM Colour monitor with 800x600 resolution and 256 colour and VGA video card 30 MB free space on the hard disk drive Windows compatible printer Mouse One free USB port Windowx XP Professional or Home operational system 26 - Installation and Configuration

27 Software installation Software installation Serial interface Insert the system CD provided by the manufacturer, select the 16 bit or 32 bit version of the software according to the operational system of the PC. Run SETUP.EXE USB interface Connect the spirometer or the rhinomanometer to a free USB port of the PC. The Windows XP recognizes the new USB device and asks for the driver. Insert the system CD to the CD drive and the Windows XP finds the appropriate drivers. In some cases a messages may appear which has to be neglected. Configuring the program Run the SETUP.EXE from the system CD/Programs/32 bit The program notices the first time it is run that is has not been configured and automatically calls the configuration part. When re configuration is needed, the Configuration can be called from the [Database] menu selecting the [Settings] submenu and [Spirometer configuration] item. The following window appears on the screen: Select the Communication port from the rolling down list: serial port or the USB port you have connected the Spirometer. Then press the [Check] button. The program displays the results in the information window in the bottom of the window. If any error occurred after its elimination, check it again. Installation and Configuration - 27

28 ECCS ATS Enter the calibrating pump s volume in [L]. Enter the number of calibrating cycles, 10 are suggested. Select the method of determination the start of FVC manoeuvre ECCS ATS In this case the start point is taken when inspiration changes to expiration. According to ATS recommendation the start point of expiration is calculated with the method of Time-back extrapolation. A tangential line is placed to the steepest point of the V(T) graph and the intersection with the time axe is taken as the start point of expiration. The corrected start time has influence on calculating the FEV*0.5, FEV*1.0 and FET Installation and Configuration

29 Configuration of Drug nebulizer Configuration of Drug nebulizer Click at the Drug nebulizer tab. The following window appears on the screen: Exit Select the interface port of the nebulizer, from the list: Diagnostic Peripherals COM 1 COM 2 COM 3 COM 4 After selection push the button [Check]. The result of checking will be shown at the lower part of the window. Select the unit of measurement of dose [mg] or [ml]. If everything is correct, press the [OK] button. Pressing the [Cancel] button exits without saving the changes. Installation and Configuration - 29

30 Measurement Modes Forced expiration and inspiration The most widely used method of dynamically examining breathing. After a few relaxed breaths ask the patient for a hard inhalation, followed by a fast expiration and a fast, deep inspiration. In this mode the device measures the following parameters: FVC Forced Vital Capacity The amount of air, which the patient moves while exhaling as fast and as deep as possible. FEV*0,5 Forced Expiratory Volume 0,5 sec The volume of air exhaled during the first 0.5 seconds. FEV*1,0 Forced Expiratory Volume 1,0 sec The volume of air exhaled during the first 1.0 seconds. 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 The greatest exhalation flow during forced exhaling. FEF*25-75% Forced mid -Expiratory Flow rate The calculated average flow for the middle of forced exhaling. MEF*75% Forced Expiratory Flow at 75% lung volume The flow, when the forced vital capacity s 75% is still in the lungs Installation and Configuration

31 Static vital capacity Static vital capacity MEF*50% Forced Expiratory Flow at 50% lung volume The flow, when 50% of the forced vital capacity is still in the lungs. MEF*25% Forced Expiratory Flow at 25% lung volume The flow, when 25% of the forced vital capacity is still in the lungs. FET Forced Expiratory Time The time of forced expiration. MTT Mean Transit Time The average time of the gas molecules from the lungs during forced exhaling. FIVC Forced Inspiratory Vital Capacity The amount of air, which the patient moves after a full exhalation while inhaling as deeply and as fast as possible. 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 The greatest flow during forced inhalation. FIF*25-75% Forced mid -Inspiratory Flow rate The calculated average flow for the middle of forced inhalation. The following graphs appear on the screen during the measurement: Volume ( time ) function Flow ( volume ) function The most widely used method of statically examining breathing. Six relaxed breaths are suggested for the patient, and Measurement Modes - 31

32 Forced expiration and inspiration vital capacity is the amount of air inhaled after a full exhalation. In this mode, the device measures the following parameters: IVC Inspiratory Vital Capacity Inspiratory vital capacity is the amount of air, which the patient inhales after a full exhalation. IRV Inspiratory Reserve Volume Inspiratory reserve volume is the largest volume of air a patient is able to inhale from an average relaxed inspiratory endpoint. ERV Expiratory Reserve Volume Expiratory reserve volume is the largest volume of air a patient is able to expiration from an average relaxed expiratory endpoint. TV Tidal Volume The breath volume is the average amount of air moved during relaxed breathing cycles. SVC Slow Vital Capacity The Slow Vital Capacity is the amount of air, which exhaled slowly by the patient after deep inspiration till the full expiration. During measurement the volume ( time ) graph is shown on the screen. Maximal Voluntary Ventilation This method of dynamically examining breathing is rarely used. You have to ask the patient to move the maximum amount of air during continuous breathing. In this mode the device measures the following parameters: MVV Maximal Voluntary Ventilation The volume of air moved in one minute during maximal voluntary respiration. MVV*f Maximal Voluntary Ventilation Frequency Respiratory frequency in one minute during maximal voluntary respiration Measurement Modes

33 During measurement the volume ( time ) graph is shown on the screen. Rhinomanometer Select the proper size of the facial mask and nose plug for the patient. Before test, ask the patient to clear its nose. Insert the nose plug into the patient s nose canal. Pay attention not to deform the nose of the patient too much. Place the facial mask to the patient s face; pay attention for the proper sealing. Always the opposite nose canal is measured where the nose plug was inserted. Flow(50 Pa) Flow rate at the 50 Pa pressure Flow(75 Pa) Flow rate at the 75 Pa pressure Flow(100 Pa) Flow rate at the 100 Pa pressure Flow(150 Pa) Flow rate at the 150 Pa pressure Flow(300 Pa) Flow rate at the 300 Pa pressure During measurement the Flow / Pressure graph is displayed real time. Measurement Modes - 33

34 Calibrating the flow sensor Calibration The device has to be calibrated after it has been turned on and after entering BTPS data. New calibration is suggested if the operating environment changes significantly. The device also has to be calibrated when changing or disinfecting the flow sensor. Calibrating the flow sensor Calibrating the flow sensor insures flow and volume measurement accuracy. The calibrating process also tests the device. Since calibration has to be performed for both inhaling and exhaling, the entire measurement system symmetry error may be corrected. You can measure with the flow sensor without calibration, but You have to calculate with an appr. 10% error. Connect that side of the flow meter, which is indicated with the patient pictogram to the calibrating syringe, as shown on the picture. Calibrating process After setting zero, press the calibrating button. Push the totally pulled out pump all the way in with constant speed, then pull out all the way. The peak flow of the calibrating manoeuvre should be in the range of 6 L/s to 8 L/s. These limits are shown on the F(V) graph with yellow lines. The calibration process is displayed on the screen real time Calibration

35 Repeat this process 10 times. Calibration constants are calculated from the results of the 5 cycles. The second 5 cycles are displayed corrected with calibration constants. A vertical yellow line divides the non corrected and corrected cycles on the V(t) graph. In the result table of calibration the following parameters are shown: Reference Nominal volume of the syringe Factor Calibration constant Measured Corrected average volume Accuracy Ratio of corrected and the reference volumes in % Possible error messages: Calibration has to contain at least 10 inhales and exhales. Try again! Asymmetry error! Try again! You have either performed the calibration incorrectly, or something is wrong with the system. Check the pneumatic connections: Is the flow sensor assembled correctly? Are the pneumatic connections connected correctly? Are the twin tubes broken? Is there water in the twin tubes? Calibration has been performed incorrectly. Possibly, the pump has not been moved all the way in and out. Try again! The flow sensor is clogged or the device is malfunctioning! Try again after correcting the error! If the device measured the calibrating volume of the exhale direction with an error greater than 20%, there may be something wrong with the device and You have to follow the steps in the Possible problems and solutions chapter. The device has to be calibrated after each replacement of flow-meter otherwise measurement cannot be analysed. Calibration - 35

36 Calibrating the flow sensor To print out the calibration result table and graphs push the print button Calibration

37 Measurement The device can store and analyse 3 measurements in all measurement modes. The measurements may be started by pressing any of start buttons. The measurements may be repeated, but the measurement started with the same button overwrites the previous measurement. Usage of nose clips is advised for lung function tests. Zero setting Press the following message: zero setting button. You will receive the If there is no flow on the flow sensor, press the [OK] button. If You could not perform the reset, You may receive one of the following messages: Possible clogging in the system. Flow during reset. If any problem arose during zero setting, perform the zero setting again after the problem has been corrected. The device will only let You perform measurements after a successful zero setting. Measurement - 37

38 Measurement of forced vital capacity After a few relaxed breaths, ask the patient to take a deep breath, followed by an exhalation as fast as possible, followed by an inhale as fast as possible. There is 1 minute to perform this. Begin the measurement by pressing one of the start buttons:,,. The colour of the displayed breath curves matches with the colour of the start button You have pressed. After You have started a measurement, the stop button activates, which You can use to stop or pause the measurement any time. It is recommended to perform three valid forced vital capacity measurements with the 3 different start buttons. Pressing the button magnifies the graphs curves: *1,5; *3; *6. You can use this feature any time, even before or after the measurement. The magnification steps cycle, so pressing this button four times returns the magnification level to its original value. Move the mouse pointer above the loop. When the pointer becomes a magnifying glass, press the left mouse button. Press the left mouse button again to return. After the measurements, You can examine the parameters. After several measurements, You can decide which measurement to include into the report, or the measurements may be repeated. The device automatically selects the best measurement. The device qualifies the best measurement, where the sum of the FVC and the FEV*1,0 parameters is the greatest Measurement

39 Vital capacity measurement Pressing the,, buttons places the parameter values and breath curves of measurement 1., 2. or 3. into the report. Move the mouse cursor over the result table. When the mouse pointer changes into a magnifying glass, press the left mouse button. Press the left mouse button again to return. Vital capacity measurement After six relaxed breaths ask the patient for a deep exhale, followed by a deep inhale, and if necessary, a few more relaxed breaths. There is 1 minute to perform this. Begin the measurement by pressing one of the start buttons:,,. The colour of the displayed breath curves matches with the colour of the start button You have pressed. After You have started a measurement, the stop button activates, which You can use to stop or pause the measurement any time. It is recommended to perform three valid vital capacity measurements with the 3 different start buttons. Pressing the button magnifies the graphs and breath curves: *1,5; *3; *6. You can use this feature any time, even before or after the measurement. The magnification steps cycle, so pressing this button four times returns the magnification level to its original value. After the measurements, You can examine the parameters. After several measurements, You can decide which measurement to include into the report, or the measurements if necessary may be repeated. The device automatically selects the best measurement. The device qualifies the best measurement, where the IVC is the greatest. Measurement - 39

40 Maximal Voluntary Ventilation Pressing the,, buttons places the parameter values and breath curves of measurement 1., 2. or 3. into the report. Move the mouse cursor over the result table. When the mouse pointer changes into a magnifying glass, press the left mouse button. Press the left mouse button again to return. Maximal Voluntary Ventilation Ask the patient to inhale and exhale as much air as possible. There is 1 minute to perform this. Of course, the measurement may stopped earlier with the stop button. The device always calculates the breath volume and frequency for the one minute. Begin the measurement by pressing one of the start buttons:,, The colour of the displayed breath curves matches with the colour of the start button You have pressed. After You have started a measurement, the stop button activates, which You can use to stop or pause the measurement any time. It is recommended to perform three valid hyperventilation measurements with the 3 different start buttons. Pressing the button magnifies the graphs and breath curves: *1,5; *3; *6. You can use this feature any time, even before or after the measurement. The magnification steps cycle, so pressing this button four times returns the magnification level to its original value. After the measurements, You can examine the parameters. After several measurements, You can decide which measurement to include in the diagnosis, or the measurements if necessary may be repeated Measurement

41 Allowing / disallowing the birthday cake The device automatically selects the best measurement. The device qualifies the best measurement, where the MVV is the greatest. Pressing the,, buttons places the parameter values and breath curves of measurement 1., 2. or 3. into the report. Move the mouse cursor over the result table. When the mouse pointer changes into a magnifying glass, press the left mouse button. Press the left mouse button again to return. Allowing / disallowing the birthday cake If the patient maximum 12 years old, it is possible to have a birthday cake appears during the measurement. The patient should be encouraged to blow out all the candles. The number of candles matches the patient s age. All the candles go out, if the patient has reached the FVC or IVC predicted value. To turn the birthday cake on, press the cake button. Graph grid on / off Press the grid button to turn the grid on or off. Entering BTPS data The state and content of the inhaled and exhaled air during the measurement is not the same. The exhaled air is appr. body temperature and saturated with vapour. The inhaled (environment) air s volume has to be corrected. This correction is called BTPS correction (BTPS - Body Temperature, Pressure, Saturated with Water Vapour). Measurement - 41

42 Unit selection Unit selection To allow BTPS correction, check the box after the BTPS text. If it checked, the correction is turned on. The BTPS correction requires the environment temperature, humidity and air pressure values, which You have to enter in the appropriate fields. The values have to be checked every time You turn on the device and if necessary modify them. This verification and modification has to be performed if the values change during the day (for example, the air pressure suddenly starts to drop). This is important, because this insures that the program correctly performs the BTPS correction. The device can work in two different unit standards. These are the following: Metric units (m - kg - sec) British units (foot - pound - sec) Two change the unit system, press the unit selector button. The change effects the following data fields: Description Metric British Patient s weight kg pound Patient s height cm feet-inch Temperature C F Air pressure milibar pound/inch Measurement

43 Predicted-value calculation The result table Presently, the program can work according to 5 algorithms. It is also possible to turn the predicted-value calculating algorithm off. The device uses the following algorithms: ECCS European Coal and Steel Community Knudson Cotton & Dust Crapo-HSU Österreichisch To turn the predicted-value calculating algorithm, press the [None] button. You can tell the program which parameters to include and which not to include in the result table for each measurement type. To access this function, move the cursor over the "Parameters" text and when the cursor changes to a table, press the left mouse button. The following window appears on the screen: Only those parameters with a checkmark in front of them will appear on the screen and in the printout. Comment A max. 60 character long comment may be attached to the measurements. This may be modified in the future. Measurement - 43

44 Save results To save results of measurements push the This feature is available only in Database version. store button. Comment To write comments of the patient push the button. This feature is available only in Database version. comment Export data to Excel To export results to the Excel table push the Excel button. The following window will appear: export to This function is available only when the Excel is started already and one Work Sheet is opened. Enter the row and column identifiers (R-row and C-column) and the starting position in the table. The name of the Work Sheet can be entered as well. If the name is omitted results will be loaded into the actual work sheet Measurement

45 Rhinomanometer The Rhinomanometer measures the resistance of nose canels. It can be used in anterior and posterior mode as well. Zero setting Press the following message: zero setting button. You will receive the Anterior measurement If there is no flow on the flow sensor, press the [OK] button. If you could not perform the reset, You may receive one of the following messages: Possible clogging in the system Flow during reset If any problem arose during zero setting, perform the zero setting again after the problem has been corrected. The device will only let you perform measurements after a successful zero setting. Select the proper size of the facial mask and the nose plug for the patient. Check the pressure in the air cushion of the facial mask. If it is not filled enough it can be refilled with a 25 ml Luer syringe. Before the measurement ask the patient to clean her/his nose. Rhinomanometer - 45

46 Anterior measurement Insert the nose plug into one of the nose holes of the patient. The nose plug has to provide sufficient sealing but avoid the strong deformation of the nostrils. Always the resistance of the opponent nose canal is being measured. Put on the facial mask take care about the proper sealing between the mask and the face of the patient. To measure the resistance of the left nose canal push the button, and respectively to measure the resistance of the right nose canal push the button. During measurement the patient should perform at least 5 inand expirations. After starting the measurement the stop button becomes active and the measurement can be aborted at any time. Pressing the button magnifies the graphs curves: *1,5; *3; *6. You can use this feature any time, even before or after the measurement. The magnification steps cycle, so pressing this button four times returns the magnification level to its original value. To get the full screen view of the graph, move the mouse pointer above the graph. When the pointer becomes a magnifying glass, press the left mouse button. Press the left mouse button again to return. After the measurements, You can examine the parameters. To get the full screen view of the parameters, move the mouse pointer above the result table. When the pointer becomes a magnifying glass, press the left mouse button. Press the left mouse button again to return. After several measurements, You can decide which measurement to include into the report, or the measurements may be repeated Rhinomanometer

47 Posterior measurement In the posterior mode the total resistance of the nose canal can be meausered. Before the measurement ask the patient to clean her/his nose. Place the pressure probe into the mouth of the patient. Put on the facial mask take care about the proper sealing between the mask and the face of the patient. To start the measurement, push the button. During measurement the patient should perform at least 5 in- and expirations. Do not move the facial mask during measurement. After starting the measurement the stop button becomes active and the measurement can be aborted at any time. Pressing the button magnifies the graphs curves: *1,5; *3; *6. You can use this feature any time, even before or after the measurement. The magnification steps cycle, so pressing this button four times returns the magnification level to its original value. To get the full screen view of the graph, move the mouse pointer above the graph. When the pointer becomes a magnifying glass, press the left mouse button. Press the left mouse button again to return. After the measurements, You can examine the parameters. To get the full screen view of the parameters, move the mouse pointer above the result table. When the pointer becomes a magnifying glass, press the left mouse button. Press the left mouse button again to return. After several measurements, You can decide which measurement to include into the report, or the measurements may be repeated. Rhinomanometer - 47

48 Provocation test After the basic measurement you may enter the name, dose and the concentration of provocation material, for this push the button. The following window appears: After entering push the [OK] button and perform the provocation procedure. Graph selection The result table The system provides three algorithms of selection, as follows: Maximum: Average: Minimum: The maximal graph is selected The average of the graphs is calculated The minimal graph is selected You can tell the program which parameters to include and which not to include in the result table for each measurement type. To access this function, move the cursor over the 48 - Rhinomanometer

49 Comment "Parameters" text and when the cursor changes to a table, press the left mouse button. The following window appears on the screen: Only those parameters with a checkmark in front of them will appear on the screen and in the printout. Maximum 3 parameters can be marked in a line. Comment A max. 60 character long comment may be attached to the measurements. This may be modified in the future. Save results To save results of measurements push the store button. This feature is available only in Database version. Comment To write comments of the patient push the button. This feature is available only in Database version. comment Rhinomanometer - 49

50 Export data to Excel To export results to the Excel table push the Excel button. The following window will appear: export to This function is available only when the Excel is started already and one Work Sheet is opened. Enter the row and column identifiers (R-row and C-column) and the starting position in the table. The name of the Work Sheet can be entered as well. If the name is omitted results will be loaded into the actual work sheet Rhinomanometer

51 Drug nebulizer Safety precautions This function is available only in data base version. The module version does not provide the drug nebulizer function. The PDD-301/p Drug nebulizer can be connected to the PDD-301/s Spirometer, PDD-301/r Rhinomanometer, PDT- 111/p Full body plethysmograph and PDD-111/d Diffusion capacity test. Thanks to the dose controlling a complete pharmacodynamic test can be performed with the Drug nebulizer. The modification of the lung function and mechanical parameters can be followed up as a function of the inhaled agent dosage. Only skilled personnel can use the Drug nebulizer. The agent to be nebulized should be a water-based solution, with the ph in the range In other case please contact the manufacturer of the parts Intersurgical Ltd. (Crane House, Molly Millars Lane, Wokingham, Berkshire RG41 2RZ, England, Tel: ). The provocation test can be performed only when the conditions of revivals are provided Do not use the drug nebulizer in a full continuo mode. The maximal duration of turning on is 15 second and afterwards a 30 second interval should be provided The usage of the equipment needs constant supervision After performing a provocation test it is advisable to use some airways diluter Set-up of provocation test To access this function, move the cursor over the [Set-up of provocation test] field and when the cursor changes to a Drug nebulizer - 51

52 Set-up of provocation test table, press the left mouse button. The following window appears on: Agent selection Select the agent from the rolling down list or enter the name of it. Give the maximal allowed dose of the agent. When this limit is reached the nebulizing will be aborted nevertheless of the results of the provocation test. If the agent is an accumulating type, put a checkmark. Test mode selection The system can be used in manual and automatic mode. In the automatic mode the inhaled dose is recorded by the system. Test type selection There are three types of the tests: Fix concentration: The patient should inhale increasing dose from the same concentration Diluting queue: The patient should inhale agent with increasing concentration for a given time. In the automatic mode the system calculates the inhaled dose. Diluting queue + dose: The patient should inhale a given dose of the agent with increasing concentration. Diluting queue If you use the Diluting queue fill the table with the sequence of concentration Drug nebulizer

53 Parameter selection Constant concentration If you use the Constant concentration enter the concentration of the agent. Nebulizer pot selection In the automatic mode enter which pot is used. Material of solution A provocation test should be finished with a solution procedure. Select an agent from the rolling down list or enter the name of it. Parameter selection Push the button [OK] to make modifications valid or [Cancel] to abandon them. Three parameters of Spirometry can be selected for following up the provocation test. At the same time three parameters can be selected. To access this function, move the cursor over the result table and when the cursor changes to mouse button. The following window appears on: a table, press the left Select a parameter from the rolling down list and enter the limit value with sign. When the change of a parameter reaches this limit value, a message appears Provocation test is successful. Push the button [OK] to make modifications valid or [Cancel] to abandon them. Drug nebulizer - 53

54 Drug nebulizing After parameter setting of the provocation test push the provocation test button. During provocation test the inhalation and spirometer measurement cycle should be repeated as long as the desired effect or the pre-set limit of agent or the end of the diluting queue is reached. The very first results of spirometry will be taken as a basic measurement. The result table of the provocation test is as follows: In the result table the following items are listed: Concentration of the agent Dose of the agent Value of the first parameter (FVC) and as a percentage of the basic parameter value Value of the second parameter (FEV*1) and as a percentage of the basic parameter value Value of the third parameter (FVC) and as a percentage of the basic parameter value In the Constant concentration mode the value of the actual dose should be entered every time, then push the [OK] button. In the automatic mode the compressor is triggered by the start of the inspiration. In the manual mode the patient should inspire the predicted dosage Drug nebulizer

55 Drug nebulizing In the Automatic mode during the Constant concentration or the Diluting queue + Dose mode the remaining dosage to be inhaled is displayed at the upper left corner of the screen. During Diluting mode the remaining time from 2 minutes is displayed at the upper left corner of the screen. In the field of [Set-up of provocation test] the actual settings are displayed. During diluting queue the next concentration is displayed at the upper left corner of the screen. In the graph the selected parameters are shown as a function of the dosage or concentration. The graph can be magnified by pushing the the steps: *1, *2, *5. button, in The grid of the graph can be turned on or off by pushing the button. The colour horizontal lines indicate the limit values of the selected parameters. The colour of the limit line is the same as the colour of the parameter s name. When the change of a parameter reaches the desired level the curve of the parameter intersects the limit line. Further more the name of the parameter is shown in inverse mode. The following message appears: The desired change is reached. More inhalation is not suggested! Are you going to proceed? If you push the [YES] button the next provocation step can be performed if the dosage limit or the end of diluting queue is not reached yet. If you push the [NO] button the provocation will be finished. If the provocation test is finish with solution the following message appears: After solution make a spirometer measurement Upon exit from the provocation test the following message appears: Save the results? Drug nebulizer - 55

56 Printing Printing If you push the [YES] button the system stores the basic, the last provoked and the soluted measures. If you push the [NO] button you will exit without storing. If you interrupt the provocation test the following message appears: Are you really going to abort the provocation test? If you push the [YES] button you exit the provocation test. If you push the [NO] button the provocation test will be reassumed. Results can be printed out by pushing the button. The result table includes the basic, the last provoked and if exists the soluted measurements. The percentage values are calculated from the basic measurement. Comment To write comments of the patient push the button. This feature is available only in Database version. comment Export data to Excel To export results to the Excel table push the Excel button. The following window will appear: export to 56 - Drug nebulizer

57 Export data to Excel This function is available only when the Excel is started already and one Work Sheet is opened. Enter the row and column identifiers (R-row and C-column) and the starting position in the table. The name of the Work Sheet can be entered as well. If the name is omitted results will be loaded into the actual work sheet. Drug nebulizer - 57

58 Export data to Excel 58 - Drug nebulizer

59 Measurement Analysis The measurement analysis function lets you examine and compare measurements just created or stored in memory or on the storage device. These can be the following: Forced vital capacity Vital capacity Hyperventilation Rhinomanometry Analysing forced vital capacity Select this function by pressing the The following will appear on the screen: pre / post button. The first three columns, show the parameters in the report (see the Forced ex- and inspiration measurement or the Forced expiration measurement section), or the parameters of the measurement, retrieved as Actual from the database (see the Measurement browsing section). The following two columns contain the parameters for the measurement retrieved as Previous measurement from the database (see the Measurement browsing section). The last column shows the difference in percent between the Actual and Previous columns. The Previous value is considered as base value. Measurement Analysis - 59

60 Analysing vital capacity The Previous measurement curve appears in red on the screen. If there is no measurement result, [DD.MM.CCYY] appears instead of the date and [HH:MM:SS] appears instead of the time. Analysing vital capacity Select this function by pressing the The following will appear on the screen: pre / post button. The first three columns show the parameter values from the report (see the Vital capacity measurement section), or the parameters of the measurement retrieved as Actual from the database (see the Measurement browsing section). The following two columns show the parameters of the measurement retrieved as Previous from the database (see the Measurement browsing section). The last column shows the difference between the Actual and Previous columns in percent. The Previous value is considered as base value. The Previous measurement curve appears in red on the screen. If there is no measurement result, [DD.MM.CCYY] appears instead of the date and [HH:MM:SS] appears instead of the time Measurement Analysis

61 Analysing hyperventilation Select this function by pressing the The following will appear on the screen: pre / post button. The first three columns show the parameter values from the diagnosis (see the Hyperventilation measurement section), or the parameters of the measurement retrieved as Actual from the database (see the Measurement browsing section). The next two columns show the parameters of the measurement retrieved as Previous from the database (see the Measurement browsing section). The last column shows the difference between the Actual and Previous columns in percent. The Previous value is considered as base value. The Previous measurement curve appears in red on the screen. If there is no measurement result, [DD.MM.CCYY] appears instead of the date and [HH:MM:SS] appears instead of the time. Measurement Analysis - 61

62 Analysing rhinomanometry This function is available when two measurements are retrieved from the database. The following window appears: The first three columns show the parameter values from the diagnosis (see the Rhinomanometer measurement section), or the parameters of the measurement retrieved as Actual from the database (see the Measurement browsing section). The next three columns show the parameters of the measurement retrieved as Previous from the database (see the Measurement browsing section) Measurement Analysis

63 Report The examination results created during the measurement may be printed. You can set-up the report format (for example, which result table and graph to print). Report preview In case of Database version select [Print preview] item from the [Database] menu. In case of Module version select [Print preview] item from the [Measurements] menu. Report print To start printing, press the window will appear on the screen: print button. The following In the report window you can select which measurement results and graphs to include in the report. Place a checkmark in front of the measurement results you would like to print. If you select a measurement that you have not performed, it will not be printed. Report - 63