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16 - Quark PFT User Manual

Safety and conformity

Safety

IEC 601-1 (1988) /EN 60 601-1 (1990);
Find reported below the complete classification of the device:

•

Class I type B device

•

Protection against water penetration: IP00, ordinary equipment unprotected against
water penetration

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Non sterile device

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Device not suitable in the presence of flammable anaesthetics;

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Continuous functioning equipment;

EMC

The system meets the EMC Directive 89/336
EN 60601-1-2
EN 55011 Class B (emission), IEC 1000-4-2, IEC 1000-4-3, IEC 1000-4-4

Quality Assurance

UNI ISO 9001 (Registration n° 387 Cermet)

Medical Device Directive (CE mark)

MDD 93/42/EEC (Notified Body 0476).
Class IIa

Содержание Quark PFT

Страница 1: ...smitted in any form without the express permission of COSMED Srl COSMED Software can be installed only in one device Excel is a registered trademark of Microsoft Corporation DBIII is a registered trademark of Bordland International Inc Lotus 123 is a registered trademark of Lotus Development Corporation Quark PFT User manual VII Edition September 2003 Copyright 1998 COSMED Copyright 2003 COSMED CO...

Страница 2: ...edical Device Directive CE mark 16 Keynotes 17 Typographic keynotes 17 Graphic keynotes 17 Systems Overview 18 Tests Products table 18 Before starting 19 Checking the packing contents 19 Quark PFT1 standard packaging 19 Quark PFT2 standard packaging 19 Quark PFT3 standard packaging 20 Quark PFT4 standard packaging 20 Quark PFT Ergo standard packaging 21 Quark PFT2 ergo Standard packaging 21 Quark ...

Страница 3: ...MIP MEP 30 Cardio pulmonary Exercise Testing CPET 30 Breath by Breath exercise testing 30 Indirect Calorimetry 31 Lactate Threshold V Slope 31 O2 Kinetics 31 Installation 33 Unpacking the system 34 Setting up the system 35 Installing the Calibration Gas Cylinders 35 Gas pressure adjustment procedure 35 Connecting cables and tubing 36 Cables and Tubing s installation sequence 37 Assemble the breath...

Страница 4: ...on report 46 Edit the calibration factors 46 O2 delay check 46 Turbine calibration 47 The calibration syringe 47 Assembling the flowmeter for calibration 47 Calibrating the turbine 48 Checking the system signals 49 The control panel 49 Using the control panel 49 Database Management 51 Spirometry patient s database 52 Patient Card 52 Visit Card 52 Test Card 53 Import export a Tests card 53 Diagnosi...

Страница 5: ...dations 63 Perform a FVC pre test 63 Test encouragement 63 Perform the FVC test with the encouragement 64 Slow Vital Capacity 65 Perform a SVC test 65 Maximum Voluntary Ventilation 66 Perform a MVV test 66 Bronchial Provocation Test 67 Bronchodilator test 67 Methacholine and Histamine Bronchial provocation Tests 67 Perform the test 68 Bronchial Provocation protocols Database 68 Enter a new Bronchi...

Страница 6: ...ffusing Capacity DLCO Test 84 Setting DLCO options 84 Recommendations 85 DLCO with breath hold standard technique 85 DLCO with apnoea standard method 85 DLCO without apnoea intrabreath method 87 Multiple breath DLCO test Steady State method 87 MIP MEP option 89 MIP MEP test 90 How to perform the test 90 Pulse oximetry option 91 The oximetry test 92 How to perform the test 92 Exercise testing 93 Re...

Страница 7: ... versa 99 Viewing predicted values 100 View predicted values 100 Anaerobic Lactate Threshold detection 100 View the Lactate Threshold 100 Detect the Lactate Threshold 100 Customise graphs for the LT viewing 100 Fittings 101 Fit a graph with a linear regression 101 Fit a graph with a Mono exponential regression 101 Calculate the Mean Value 102 Oxygen Kinetic 102 Run the O2 Kinetic function 102 Info...

Страница 8: ... parameters to view 111 Select the parameters to view during the test 111 Sort the parameters 111 Steady State 111 Customise the Steady State detection criteria 111 Printout reports 112 Set up the printout 112 Select parameters to be printed 112 Customise the printout header 112 Electronic reports pdf 113 Print the current window 113 Print the customised report 113 Events management during exercis...

Страница 9: ...est termination 128 Considerations for accuracy 129 Performing the test 130 An example of testing protocol 130 System maintenance 131 System maintenance 132 Cleaning and disinfection 132 Cleaning the turbine flowmeter 133 Precautions during the cleaning of the turbine 133 Suggested disinfection solutions 133 Cleaning the Breathing valve 133 Masks cleaning and disinfection 135 Disassembling the dif...

Страница 10: ...dations 144 Predicted values 145 ERS93 145 Reference Adult 145 Reference Paediatric 145 KNUDSON 83 145 Reference Adult Paediatric 145 ITS White race 145 Reference Adult Paediatric 145 ITS Black race 145 Reference Adult Paediatric 145 LAM 145 Reference Adult Paediatric 145 Multicéntrico de Barcelona 145 Reference Adult Paediatric 145 NHANES III 145 Reference Adult Paediatric 145 Automatic diagnosis...

Страница 11: ...Getting started ...

Страница 12: ...d always be kept on hand 2 Safety measure accuracy and precision can be assured only using the accessories described in the manual or given with the device Actually non recommended accessories can affect safety unfavourable Before using non recommended accessories it is necessary to get in touch with the manufacturer ordinary equipment maintenance inspections disinfection and cleaning are performe...

Страница 13: ...inspect the components after cleaning and before each patient test 8 This device is not suitable for use in presence of flammable anaesthetics It is not an AP nor an APG device according to the EN 60 601 1 definitions 9 Keep the device away from heat and flame source flammable or inflammable liquids or gases and explosive atmospheres 10 In accordance with their intended use Quark PFT is not to be ...

Страница 14: ...provocation tests The bronchial provocation tests must be executed according to the doctor s discretion There are not data that reveal specific contraindication for the bronchial provocation test through inhalation The modern standard processes have been revealing secure in several clinical studies However it is recommendable to respect the following contraindications Absolute contraindications Se...

Страница 15: ...N 60601 1 they are not suitable for use in presence of flammable anaesthetic mixtures with air oxygen or nitrogen protoxide If not otherwise stated in the shipping documents Cosmed equipment have been conceived for operating under normal environmental temperatures and conditions IEC 601 1 1988 EN 60 601 1 1990 Temperature range 10 C 50 F and 40 C 104 F Relative humidity range 20 to 80 Atmospheric ...

Страница 16: ...y equipment unprotected against water penetration Non sterile device Device not suitable in the presence of flammable anaesthetics Continuous functioning equipment EMC The system meets the EMC Directive 89 336 EN 60601 1 2 EN 55011 Class B emission IEC 1000 4 2 IEC 1000 4 3 IEC 1000 4 4 Quality Assurance UNI ISO 9001 Registration n 387 Cermet Medical Device Directive CE mark MDD 93 42 EEC Notified...

Страница 17: ...re the typographic keynotes used in the manual Style Description Bold indicates a control or a key to be pressed Italic indicates a messages shown by the firmware Graphic keynotes These are the graphic keynotes used in the manual Illustration Description shows the button to click in the software to activate the related feature ...

Страница 18: ...ntegrates PFT2 and PFT3 features to become the Complete Pulmonary Function Testing instrument ERGO Option The PFT 2 and PFT 4 can be enhanced with the Pulmonary Gas Exchange module allowing breath by breath analysis indirect calorimetry and RS232 ergometer control PFT3 can be upgraded to PFT4 or PFT4 ERGO Tests Products table Test PFT 1 PFT 2 PFT 3 PFT 4 PFTErgoPFT2ergoPFT4ergo Forced Vital Capaci...

Страница 19: ...5A C00067 02 94 1 Registration card C01340 02 91 1 User manual Quark PFT C01999 02 DC 1 Conformity declaration Quark PFT2 standard packaging Code Qty Description C00932 01 04 1 Quark PFT 2 unit C02120 01 05 1 Turbine Ø 28mm C02171 02 11 1 Kit optoelectronic reader Quark PFT2 3 4 A 182 310 001 5 Antimoisture filter C01590 01 05 1 Breathing valve PFT2 1 way C00243 01 06 1 Calibration syringe 3 litre...

Страница 20: ...V T630 mA C00067 01 94 1 Registration card C01340 02 91 1 User manual QuarkPFT C01999 02 DC 1 Conformity declaration Quark PFT4 standard packaging Code Qty Description C00934 01 04 1 Quark PFT4 unit C02120 01 05 1 Turbine Ø 28mm C02171 02 11 1 Kit optoelectronic reader Quark PFT 2 3 4 C01730 01 05 1 Breathing valve PFT3 4 3 ways C00243 01 06 1 Calibration syringe 3 litres C02210 02 08 2 Permapure ...

Страница 21: ...5x20 250V T630 mA A 680 024 125 2 Time Lag Fuses 5x20 250V T1 25A C00067 02 94 1 Registration card C01340 02 91 1 User manual QuarkPFT C01999 02 DC 1 Conformity declaration Quark PFT2 ergo Standard packaging Code Qty Description C00936 01 04 1 Quark PFT2 ergo unit C02120 01 05 1 Turbine Ø 28mm C02171 02 11 1 Kit optoelectronic reader Quark PFT 2 3 4 C01590 01 05 1 Breathing valve PFT2 A 800 900 00...

Страница 22: ...re C02210 02 08 1 Permapure L2m C01399 02 12 1 Cable in HR TTL C02125 01 10 1 Mask mouth nose breath adult S C02135 01 10 1 Mask mouth nose breath adult M C02145 01 10 1 Mask mouth nose breath adult L C00861 01 06 1 HR probe A 661 200 001 1 HR elastic belt A 661 200 002 1 HR polar transmitter C00269 01 20 20 PTE soft mouthpiece C00137 01 20 50 Paediatric paper mouthpieces C00136 01 20 50 Adult pap...

Страница 23: ... software it is possible to fill in an electronic form with the customer information 1 To run the software double click on the icon Registration or select Registration from menu 2 Type the requested information and click Send to send the form via e mail to COSMED How to contact COSMED For any information you may need please contact the manufacturer directly at the following address COSMED S r l Vi...

Страница 24: ...der 0 3 CO 0 3 CH4 21 O2 balance N2 A 860 000 007 1 O2 cylinder C01500 01 04 1 Trolley for Quark PFT C01700 01 04 1 Trolley with arm for Quark PFT A 870 150 001 1 Pressure regulator for cal DLCO cylinder A 870 150 002 1 Pressure regulator for O2 cylinder C09001 02 99 1 Spirovis system for MIP and MEP measurement C00689 01 30 1 Mask mouth nose breath ID28 adult XL C01278 01 30 1 Mask mouth nose bre...

Страница 25: ...e VGA SVGA monitor Serial Port RS 232 available 2 serial ports in case of Ergometer control An USB port can replace one RS232 serial port if using the USB RS232 adaptor Cosmed code A 388 410 001 Any Mouse and Printer compatible with the MS Windows operative system PC conform to European Directive 89 336 EMC ...

Страница 26: ...acy 0 03 Carbon Monoxide sensor CO Type NDIR Response time 200 ms Range 0 0 3 Accuracy 0 003 Methane sensor CH4 Type NDIR Response time 200 ms Range 0 0 3 Accuracy 0 003 Humidity absorber Capillary of Nafion Permapure Power Supply Voltage 100V 240V 10 50 60Hz Power consumption 100W Environmental Sensors Temperature 0 50 C Barometer 400 800 mmHg Humidity 0 100 Dimension and Weight Dimensions 17x30x...

Страница 27: ...Measurements ...

Страница 28: ...5 l sec Mid exp flow between 25 75 FVC FET100 sec Forced expiratory time FEV2 l Forced Expiratory Volume in 2 sec FEV3 l Forced Expiratory Volume in 3 sec FEV2 FVC FEV2 as a percentage of FVC FEV3 FVC FEV3 as a percentage of FVC FEV1 VC Tiffenau index FEF50 75 l sec Mid exp flow between 50 75 FVC FEF75 85 l sec Mid exp flow between 75 85 FVC FEF0 2 1 2 l sec Mid exp flow between 0 2 l 1 2 l FiVC L...

Страница 29: ...ameter FRC l Functional Residual Capacity RV l Residual Volume TLC l Total Lung Capacity Vtot l Total volume during the test FetN2 Final Nitrogen Concentration Wash out time m Duration of wash out VDA L Anatomic dead space LCI mm ss Lung Clearance Index AMDN mm ss Mean Dilution Number FRC TLC FRC TLC ratio CEV l Cumulated Volume of inspired Oxygen RV TLC RV TLC ratio Motley index Closing Volume te...

Страница 30: ...y Vt l Tidal Volume MIP MEP Symbol UM Parameter MIP cm H2O Maximum inspiratory pressure MEP cm H2O Maximum expiratory pressure Cardio pulmonary Exercise Testing CPET The Ergo option makes the Quark PFT a complete Cardiopulmonary Exercise Testing system able to measure the following parameters Breath by Breath exercise testing Symbol UM Parameter VO2 ml min Oxygen Uptake VCO2 ml min Carbon Dioxide ...

Страница 31: ...y Kg Energy Expenditure pro Kg FAT Kcal day Fats CHO Kcal day Carbohydrate PRO Kcal day Protein FAT Fat CHO Carbohydrate PRO Protein npRQ Respiratory quotient not protein Lactate Threshold V Slope Symbol UM Description VO2 LT l m Lactate Anaerobic Threshold STPD R LT Respiratory Quotient LT Time LT hh mm ss Time LT VCO2 ml min CO2 output LT STPD VE l min Ventilation LT BTPS HR bpm Heart Rate LT O2...

Страница 32: ...32 Quark PFT User Manual ...

Страница 33: ...Installation ...

Страница 34: ...tely Your system has to be installed by COSMED or by an authorised reseller Excessive amount of dust and miscellaneous clutter around the instrument can eventually cause malfunctions due to overheating of components we strongly suggest to keep the unit in a clean environment and well ventilated as possible Quark PFT and accessories can have place on the trolley as shown in the following illustrati...

Страница 35: ...ent procedure The gas regulator has an adjustable second stage that must be adjusted only when used for the first time This is necessary to protect the internal demand valve from the high pressure surge that can be generated when the cylinder is opened 1 Make sure that the regulator is turned off before opening the cylinder valve 2 Open the cylinder valve by turning the valve counter clockwise 3 A...

Страница 36: ...ns A Heart Rate Probe connector D Flowmeter connector E Calibration plug F Power switch G Sampling tube connector H Breathing valve connector I DLCO mix gas connector L Cal gas 16 O2 5 CO2 connector M O2 gas connector O RS232 Serial Port for PC connection P Ground snap connector Q Power cable connector R Switch 110V 220V ...

Страница 37: ...PC does not have a RS232 port please use the USB RS232 adapter A 388 410 001 available as an accessory 4 Connect the DLCO cylinder to the Quark PFT DLCO and adjust its pressure between 5 and 6 bar 5 Connect the O2 cylinder to the Quark PFT O2 and adjust its pressure between 5 and 6 bar 6 Connect the O2 CO2 calibration cylinder to the Quark PFT CAL and adjust its pressure between 5 and 6 bar 7 Conn...

Страница 38: ...ter always and we recommend to replace it every 3 months Using the Ultimate Seal The ultimate seal is a moulded of Elasto Gel a glycerine based hydrogel This product is a unique polymer gel that forms an intimate seal between the face and the mask It has to be used for mask applications on hard to seal faces and where leaks are not tolerated Will not irritate the skin Contains no adhesives Has no ...

Страница 39: ...ask is now ready to be placed on the subject s face To remove seal on mask The Ultimate Seal have been conceived for a single patient use only it can not be cleaned or sterilised If mask requires cleaning for a new patient application then pull off and dispose of the Ultimate Seal To keep the seal clean between use keep it attached to the mask and place the clear film against the Ultimate Seal gel...

Страница 40: ...am will load up a dialog box and ask for a directory where to be installed 5 When the installation is over the program will advise you with a message indicating that the installation has been successfully completed click on End Note the directory for the Ergo software must be the same of the Quark PFT spiro Run the software 1 In the Windows Program Manager open the Program Group in which the softw...

Страница 41: ...ld Press the Enter key to confirm the information input on the dialog box or press the Esc key to cancel changes Use of the mouse To move the cursor among fields move the mouse on the desired field and left click Click on the OK button with the Left button of the mouse to confirm the information input on the dialog box or click on Cancel button to cancel changes Scroll bars Some windows are provid...

Страница 42: ...42 Quark PFT User Manual ...

Страница 43: ...Calibration ...

Страница 44: ... File from the calibration program Setting reference values Before starting calibrating make sure that the system has been configured correctly by setting the right values of gas concentration of room air i e 20 95 O2 and 0 03 CO2 of gas mixture contained in the cylinders and the volume of the calibration syringe i e 3 litres To set the reference values This operation must be performed only the fi...

Страница 45: ...e the software displays the new calibration factors vs the old ones FRC Calibration This calibration must be repeated at least daily A new calibration before any FRC or CV test is strongly recommended 1 Remove the sampling line from the flowmeter 2 Ensure that the O2 cylinder is properly connected to the rear panel of the Quark PFT and check that the pressure of the gas is in the range 5 6 bar 3 E...

Страница 46: ...alibration program choose Print from the File menu Edit the calibration factors The last sensors calibration factors can be either edited or viewed To do this choose Gas Results from the File menu To view or edit the last Turbine calibration factor choose Turbine results from the File menu Note To restore factory setting press Default button in the dialog box Once you press the default button you ...

Страница 47: ...ee Maintenance However in order to ensure accuracy it s recommended to run periodically the calibration procedure Calibration has to be carried out with a calibration syringe of 3 litres volume the calibration procedure is totally managed by software A measurement system should be calibrated daily in order to ensure maximum accuracy and reliable test results If a correct maintenance is provided it...

Страница 48: ...on initially pushed all the way in move the piston in and out for 5 inspiratory strokes and 5 expiratory strokes in order to get the first values appearing on the display Then move the syringe piston for other 10 strokes IN and EX 4 At each of the 10 steps the software displays the results of the manoeuvre and the percentage error in the reading 5 At the end of this operation the software displays...

Страница 49: ...ng the signals acquired by the system both as voltages and processed data 2 Activating Disactivating the valves the sampling pump and other installed components for example oxymeter Using the control panel Sampling pump Sampling flow rate Breathing valve air valve Apnoea valve Calibration valve On off cylinders On Off infrared sources mV real values display Select all channels Deselect all channel...

Страница 50: ...50 Quark PFT User Manual ...

Страница 51: ...Database Management ...

Страница 52: ...hive Find a patient in the archive Enter a new patient in the archive Delete current patient from the archive Edit the current patient card Visit Card It collects all information relative to the visit diagnosis visit description and to the patient information subject to change between one visit and another height weight smoke Each patient can be related to several Visit Cards provided they have be...

Страница 53: ...tive visit and patient card 1 Select the patient 2 Choose the test and press the key by side All data will be imported exported in the XPO file format Cosmed proprietary Diagnosis Database The program allows to manage a diagnosis database whose records are composed by a diagnosis ID code and a string of text The report of the visits can be done either by typing the desired text in the field Diagno...

Страница 54: ...er a search string into the Find field and press Find to view the data concerning a subject already in the database You can search for Last name ID code or Progressive Or Press List to view the list of patients in the database Press Next or Previous to view the data corresponding to the next or to the last patient Press OK to confirm The Next and Previous buttons allow to move to the next or the p...

Страница 55: ...end of the operation before performing any other function Delete a test To delete an ergometry test select Test Delete test To delete a spirometry test press the proper button in the Test Card Backup and restore It is strongly recommended to backup files a warning message will be displayed monthly This function allows the user to restore the data if the PC or the HD will not work anymore Backup 1 ...

Страница 56: ...asurements It is possible to configure the units of measurements weight and height for printing and viewing To select the units of measurement click on cm Kg or in lb according to the desired format Using extra fields The Patient s database is organised in 3 different cards Patient card Visit Card and Test card where it is possible to store the information about patients and visits Besides the sta...

Страница 57: ...Spirometry ...

Страница 58: ...llow the calculation of the LLN Lower Limit of Normal range at least one FVC test has been performed To enable disable the automatic diagnosis 1 Click on Enable Automatic Interpretation checkbox to enable or disable the calculation and the visualisation of the automatic interpretation 2 Select the LLN Lower Limit of Normal Range criteria among the ATS LLN Pred 0 674 SD ERS LLN Pred 1 647 SD or 80 ...

Страница 59: ... Sort Drag the parameter up or down with the mouse Customise Add modify and delete custom parameters If it is necessary to restore the default parameters press the button in the left corner of the window to initialise the parameters database Predicted values manager The program contains a preset of predicted equations but the user is allowed to customise its own predicted sets Select Predicteds fr...

Страница 60: ...fy a new Name To import a set of predicteds click on the Import button and select a file of Predicteds files type To export a set of predicteds click on the Export button In the list Set current predicteds choose the current predicteds for printing and viewing Set the current predicted Quark PFT allows to calculate the predicted values according to the following configurable sets Adults Paediatric...

Страница 61: ...e preceded by 3 rows of customisable header usually they contain the name and the address of the Hospital using the spirometer Data Patient and visit information are printed below the header These data are reported on 3 columns and 5 rows the user may configure the disposition change and eventually cancel the fields as he prefers Margins Configures the print margins from the borders of the paper T...

Страница 62: ...oluntary Ventilation FRC Nitrogen Wash out CV Closing Volume DLCO CO Diffusing capacity P0 1 Respiratory Drive Note The FVC SVC and MVV tests must be performed with the flowmeter disconnected from the breathing valve Before performing any test make sure that 1 Quark PFT is properly connected to your PC and the selected serial port COM1 COM2 corresponds to the one effectively use 2 The name shown o...

Страница 63: ...t perform the test it is recommended to enable the encouragement function which shows exactly the manoeuvre of the FVC test Perform a FVC pre test 1 Select Forced Vital Capacity pre from the Test menu and wait for the green led is prompted on the right side of the screen 2 Explain the manoeuvre to the patient and press the F2 key 3 Wait some seconds and perform the test 4 After having performed th...

Страница 64: ...64 Quark PFT User Manual Perform the FVC test with the encouragement 1 Select Encouragement from View menu 2 Perform the test as explained in the previous paragraph ...

Страница 65: ...r the green led is prompted on the right side of the screen 2 Press F2 and instruct the Patient to breath normally until the message carry out is prompted then ask to perform a Slow Vital Capacity deep inhalation maximal slow expiration and deep inhalation again 3 Press F3 or wait for automatic interruption 5 seconds without flow in order to visualise the V t graph together with the main parameter...

Страница 66: ...test menu and wait for the green led is prompted on the right side of the screen 2 Press F2 and make the Patient breath as much deeply and rapidly as possible for at least 12 seconds 3 Press F3 or wait for automatic interruption 5 seconds without flow in order to visualise the V t graph together with the main parameters compared to the predicted values 4 To visualise the V t graph and the main par...

Страница 67: ...eezing cough and a little or not response to bronchodilator Other patients demonstrate spirometric improvement after use of bronchodilator have diurnal variation in peak flows In this groups aerosolised bronchial challenges are used to confirm a diagnosis of Asthma We can summarise the use of the test as follows 1 Diagnose asthma 2 Confirm a diagnosis of asthma 3 Document the severity of hyperresp...

Страница 68: ...ator is usually assessed in terms of change in the FEV1 vital capacity or airways resistance on the basis of serial measurements FVC manoeuvres in which the results of the initial test constitute the reference values The international literature proposes several standardised protocols in order to address the methodological issues of the various available techniques The possibility to store a bronc...

Страница 69: ...iew Volume Time graph F6 view data of the test F7 view bronchial provocation response If you need more than one visualisation meantime use the New Window function from the Window menu If you need to display a list of visits Select Visits list from the File menu Type the name of the Company and or the time interval desired or simply confirm for the complete list Tests of the current patient If a cu...

Страница 70: ...nd the diagnosis and the second one with the measured parameters according to the ATS recommendations The 3rd page will contain the bronchoprovocation response Select the desired options FVC graph Prints the F V and V t curves for the best FVC test One page no ATS Prints data and graphs on the first page Response Prints the bronchoprovocator response FVC post Prints data and graphs for the Post FV...

Страница 71: ... installed and set as the default printer it is possible to store the printout report automatically in any location of the HD or eventually LAN paths according to a customizable filename format It is possible to define the created filename format selecting File Page Set up see Page set up Export data With this function you can export the test data in 4 different formats txt ASCII xls Microsoft Exc...

Страница 72: ...72 Quark PFT User Manual ...

Страница 73: ...Lung Volumes ...

Страница 74: ...nt breathe 100 O2 for several minutes usually 7 minutes or until the final concentration of N2 is below 1 5 2 5 Since the whole expired nitrogen come from the initial lung volume a simple equation allows to get FRC value The main parameters measured during this test are FRC Functional Residual Capacity CEV Total ventilated volume during the test Wash out time Test duration RV Residual Volume TLC T...

Страница 75: ...e Test menu and wait for the green led is prompted on the right side of the screen 2 Connect the patient to the breathing valve and invite him her to breathe normally 3 Wait for the message carry out slow vital capacity is prompted on the screen of the PC and let the patient to perform a slow vital capacity 4 Wait for a normal breathing pattern is again established and press Start F2 to begin the ...

Страница 76: ... to the emptying of the latest alveoli richest of N2 because not reached by the inspired O2 Increased values of CV can be related to lung pathologies The main parameters calculated during this test are CV Closing Volume Delta N2 Delta N2 between 750ml and 1250ml of expiration Recommendations The system must be calibrated before each test See Calibration chapter The flowmeter must be connected prop...

Страница 77: ...raph view data of the test At the end of the test you can edit the test Display the test to be modified Right click with the mouse and select Edit to change the test properties wash out volume sample volume effective breath hold time calculation ...

Страница 78: ...78 Quark PFT User Manual ...

Страница 79: ...P0 1 Respiratory drive ...

Страница 80: ...y drive options 1 Select Settings from Options menu 2 Select Respiratory drive 3 Set the desired value in all the fields described in the next table Option Description Vt Stability threshold Recognition criterion of regular respiration Recommendations Connect the P0 1 valve on the breathing valve connector on the front panel of the Quark system Verify that the cylinder driving the P0 1 valve O2 CO...

Страница 81: ...y drive 81 6 To visualise the V t graph and the main parameters press the follow buttons view P0 1 graph view Volume Time graph view breath by breath data 7 Press the Abort button to stop the acquisition discarding the results ...

Страница 82: ...82 Quark PFT User Manual ...

Страница 83: ...Lung diffusing capacity ...

Страница 84: ...ient between air and blood and the density of each gas Measurements of the diffusing capacity is usually performed using Carbon Monoxide CO because it has a great affinity for Haemoglobin 210 times that of O2 it is soluble in blood and its concentration in venous blood is insignificant The main techniques are 1 Single Breath with Apnoea ATS ERS standard 2 Single Breath without Apnoea requires a fa...

Страница 85: ...d Analysing the concentrations of CO and the Tracer gas CH4 belonging to a portion of the expired volume collected volume obtained by discarding the beginning of the expiration wash out volume the test indexes are determined The wash out volume 0 75 1 L for normal subjects 0 25 0 5 L with reduced Vital Capacity the collected volume 0 5 1 L and the calculation of the breath hold time ESP JONES OGIL...

Страница 86: ...o inhale up to Total Lung Capacity and to hold the breath until the expiratory valve will be automatically open a quick full expiration shall follow and the test will be completed A dashed line indicates the 90 of the Best Vital Capacity if a FVC or SVC test is available in the archive otherwise it indicates the 90 of the Predicted VC in order to verify the correctness of the manoeuvre Double clic...

Страница 87: ...tal Capacity if a FVC or SVC test is available in the archive otherwise it indicates the 90 of the Predicted VC in order to verify the correctness of the manoeuvre Double click with the left mouse button in order to modify the test options wash out volume sampling volume calculation of the real apnoea time Multiple breath DLCO test Steady State method In this test the patient breathes regularly du...

Страница 88: ...88 Quark PFT User Manual ...

Страница 89: ...MIP MEP option ...

Страница 90: ... the Quark and insert the flowmeter into the valve Use a rubber mouthpiece connected to the antibacterial filter and nose clip 3 Select MIP MEP from Test menu and wait for the green led is prompted on the right side of the screen 4 Breathe normally for some time 5 Carry out a maximal expiration for the MIP or a maximal inspiration for the MEP 6 Press F2 during the expiration inspiration 7 Inspire ...

Страница 91: ...Pulse oximetry option ...

Страница 92: ...1 Connect the pulse oximeter to auxiliary RS232 port on the back of the Quark PFT 2 Connect the probe to finger or ear of the Patient different probes are available 3 Select Oximetry from the Test menu and wait for the green led is prompted on the right side of the screen 4 In the first part of the test the HR and SpO2 values together with a plethysmographic graph are displayed The graph monitors ...

Страница 93: ...Exercise testing ...

Страница 94: ... 22 C the temperature adequate for the test execution even for short efforts values till 26 C can be considered acceptable in presence of an efficient air ventilation Ending the test The patient should be monitored with ECG for at least 8 minutes in resting conditions or until he returns to the pre exercise conditions Preparing the patient To enhance the value of a diagnostic test it s very import...

Страница 95: ...of drugs tobacco to the physical fitness and symptoms produced with the exercise Patient assent The patient is informed that he will be submitted to a maximum effort which could be stopped at any moment and of the risks of the test execution Ending the test Test may end when the maximum value of the oxygen consumption has been reached and the patient s response established ...

Страница 96: ...and toolbar while the first data will be displayed in a table format 6 At this point the software starts showing data on the monitor but without saving them this in order to monitor the patient before starting the test To start storing data press F2 Abort the test without saving data Choose Abort from the Test menu or press Alt F3 End the test saving data 1 Choose End from the Test menu or press F...

Страница 97: ...K to confirm Set the markers Select Marker from the Events menu Automatic protocol The software allows to automatically control the ergometer according to the protocol previously selected Anyway it is allowed to change it even after the test is started Modify the load during the test 1 During the test choose Ergometric protocol from the Events menu 2 Select the row corresponding to the desired loa...

Страница 98: ...n table form 1 Select Data from the View menu 2 Select the test to visualise in the list box and press OK Creating graphs The software is provided with powerful functions for creating charts You can add custom graphs to create exactly what you need View data in graph form 1 Choose Graph from the View menu 2 Select the tests to visualise from the list and press OK 3 Choose the parameters you requir...

Страница 99: ...t interpolated make the graph scattered Marker highlight with a symbol all steps of the test in which the marker button was pressed Squared makes the graph a square Without recovery exclude from the graph all points of the recovery phase Mark points marks each point with a symbol Min Max allows to set manually the axes values Step Set the axes scale step Switch from graph to data and vice versa Wh...

Страница 100: ...rom the View menu Detect the Lactate Threshold 1 Choose Calculate LT from the Test menu 2 For calculating it automatically on the Lactate Threshold dialog box click on the Auto detect button 3 For adjusting manually the point you want to detect move the scroll bar on the dialog box by pressing the arrow buttons Data and graph of the LT will be automatically redrawn 4 Press Ok button to save your c...

Страница 101: ...e in the graph pressing the Left key or using the and keys 5 Select the second point X2 moving the mouse on the desired place in the graph pressing the Right key or using the and keys 6 Press OK to confirm Fit a graph with a Mono exponential regression 1 Make active the graph window any Y vs any X graph 2 Right click and select Fitting 3 Choose Mono exponential in the type combo box 4 Select the f...

Страница 102: ...ith Constant Load Exercise Tests The aim of this function is to find the dynamic response of the rising and falling edges of the VO2 together with the Oxygen Deficit and Oxygen Debt Run the O2 Kinetic function 1 Make active a VO2 vs Time graph window 2 Press the right key of the mouse and select O2 Kinetic 3 Select the beginning of the exercise phase t1 moving the mouse on the desired place in the...

Страница 103: ...and CHO type the UN Ureic Nitrogen value into the field All the nutritional parameter will be recalculate considering the UN value Summary The summary feature allows to summarise test results according to the workload and phase during the test View the summary 1 Choose Summary from the View menu 2 The summary of the current test active window will be displayed Print the data It is possible to prin...

Страница 104: ... Setup to customise the print Print the report 1 Select the report to be printed from File menu 2 Press OK to print or Setup to customise the print 3 To only view the report without printing it press Shift during the selection View the report This function allows to show a preview of a selected report 1 Select Report from the View menu 2 Select the test and the report to visualise and press OK to ...

Страница 105: ...ant to replace with others values and press OK to confirm the editing The software will recompute all the parameters Both the tables and the graphs will be automatically updated Data filtering 1 Choose Edit test from the Test menu 2 Press the button Filtering and choose the option Discard invalid steps to automatically eliminate all the invalid steps 3 Press the button Filtering and choose the opt...

Страница 106: ... cursor on the step you want to delete and press the button Delete step Advanced Editing This feature allows to perform some advanced editing of the data stored in the software 1 Choose Edit test from the Test menu 2 Press the Advanced button and select from the following options Option Function Delete steps deletes the steps meeting the selection criteria Smoothing applies a moving average to the...

Страница 107: ... measured data can be reduced in 2 different ways Graphical noise suppression using the mouse Threshold noise suppression applying a filter to the measured data Apply the graphical noise suppression 1 Make active a graph or a data window corresponding to the test that you want to modify 2 Press the right key of the mouse and select Smart Edit 3 Select the parameter that you want to modify 4 Point ...

Страница 108: ...summary to present the parameter in the summary and press the Formula button 4 Insert the mathematical formula by using the appropriate tools and press OK twice to confirm Create a new predicted parameter 1 Choose Customise predicted from the Options menu 2 Press the New button if you want to create a new parameter or Modify if you intend to modify an existing one 3 Type the desired value in the f...

Страница 109: ...nds sep and Column sep according to the program you want to use With the xpo Cosmed format you can import export the tests performed on another Quark equipment 4 Select the folder type the file name and press OK to confirm DDE with Excel If Microsoft Excel is installed on your PC you can export a test simply pressing a button on the toolbar To send a test to Excel select Send to Excel from the Tes...

Страница 110: ...sage to advise when switching to the next load 4 Enable the Drive Ergometer check box to let the software control the ergometer Select the Initial Command if the ergometer need it 5 Enabling the option Relative Increments the loads refer to the previous step 6 Press Generate and enter the values to generate a protocol from only one load i e 30 Watt each minute for a total of 20 steps and press OK ...

Страница 111: ...ration Sort the parameters It is possible to sort the parameters both for viewing and printing purposes according to the desired order 1 Select Sorting parameters from the Options menu 2 Move the parameters in the order you want by pressing and holding the left mouse button 3 Press OK to maintain the current configuration Steady State The program has an algorithm to tag sets of steps as Steady Sta...

Страница 112: ...to print a large number of parameters it is advisable in order to simplify the analysis of the results to printout desired parameters only 1 In the report configuration window select Parameters 2 Select the parameters you require to be printed in the data printout The number of parameters which can be printed depends upon the size of the paper in use see Printer Layout and from the orientation of ...

Страница 113: ...s possible to define the created filename format selecting Options Printout header and then Name format Print the current window The print current window function is enabled when the active window is a graph or a data report 1 Select Print current window from File menu 2 Press OK to print or Setup to customise the print Print the customised report This function is enabled only after having customi...

Страница 114: ...e Making the patient inspire completely up to TLC level this is necessary to place the loop correctly into the rest F V loop of the forced Vital Capacity test Overlapping the F V loop acquired during exercise and the F V loop performed at rest Flow Volume loop during the test 1 Start with normal Exercise test and begin the memorisation of breath values F2 2 During a steady state select F V loops f...

Страница 115: ...spirogram event has been carried out in the list box and press OK 3 Select View from the Events menu choose the desired event and press OK 4 Select Print Current Window from the File menu to print the F V curve page It is possible to edit the F V loops event in the following way 5 Select Edit from the Event menu to change the F V loop at rest the list contains all the FVC test carried out by the s...

Страница 116: ...116 Quark PFT User Manual ...

Страница 117: ...Resting Metabolic Rate Test ...

Страница 118: ...these measurements the resting energy expenditure RMR and respiratory quotient RQ can be calculated The RQ represents the ratio of carbon dioxide exhaled to the amount of oxygen consumed by the individual RQ is useful in interpreting the results of the RMR The abbreviated Weir equation is probably the most common calculation of RMR Abbreviated Weir equation RMR 3 9 VO2 1 1 VCO2 1 44 How to perform...

Страница 119: ...normally 10 litres min the turbine calibration has to be performed with very slow manoeuvres each complete manoeuvre in about 10 15 seconds to obtain the best accuracy 2 Use the following correction for the dead space VD 50 ml for the small mask 60 ml for the medium mask 70 ml for the large mask ...

Страница 120: ... the patient s data and select the RMR mode 1st picture 5 Press Other Data and enter the dead space value 50ml Small mask 60ml Medium mask and 70ml Large mask It is possible to enter the Ureic Nitrogen value NU 2nd picture 6 Confirm and start the test by pressing OK Selecting RMR the system set automatically the following options Data acquisition with a 30 seconds average RMR protocol which is 5 m...

Страница 121: ...ex BMI and interpretation Graph of the energetic expenditure for all the data acquisition interval highlighting the selected average interval In order to verify the goodness of the test check that the ventilation and respiratory frequency are similar to the predicted ones 12 breaths min for the respiratory frequency and 6 litres min for the ventilation and the heart rate is the rest heart rate of ...

Страница 122: ...aking in the first minutes it is possible to modify the interval of the average Right click and select Edit RMR It is possible to move the start and the end lines To move the start line left click on the exact time in which you want to start the calculations for the end line right click Print The print of the current window generates a report similar to the one in the following page ...

Страница 123: ...Chapter 13 Resting Metabolic Rate Test 123 ...

Страница 124: ...124 Quark PFT User Manual ...

Страница 125: ...Sub maximal Exercise Testing ...

Страница 126: ... disease or estimating maximal oxygen consumption correctly performed sub maximal tests can provide a valid estimate of cardiorespiratory fitness Pre test screening Pre test health screening is essential for risk stratification and for determining the type of test that should be performed and the need for an exercise test prior to exercise training A thorough pretest health screening includes the ...

Страница 127: ...rate and VO2 have a linear relation over a wide range of values thus the slope of HR VO2 regression can be extrapolated to an assumed maximum heart rate Mechanical efficiency i e VO2 at a given work rate is consistent Although if done correctly sub maximal exercise tests provide valuable information concerning cardiorespiratory fitness they have extremely limited diagnostic capabilities and should...

Страница 128: ...chanical or electrical failure that may compromise the accuracy of the test results or monitoring capabilities the test should be terminated until the problem is corrected General Indications for Stopping an Exercise Test in Apparently Healthy Adults Onset of angina or angina like symptoms Significant drop 20 mmHg in systolic blood pressure or a failure of the systolic blood pressure to rise with ...

Страница 129: ...es of exercise in these cases Having the subject repeat the first test may improve reliability particularly if the subject has never previously performed such a test Factors that can cause variation in the heart rate response to testing Dehydration Prolonged heavy exercise prior to testing Environmental conditions e g heat humidity ventilation Fever Use of alcohol tobacco or caffeine 2 to 3 hours ...

Страница 130: ...the 85 of the Hrmax or it happens an event listed in the section Test termination 4 Display a VO2 Kg vs HR plot 5 Right click on the graph and select VO2 submax from the pop up menu If the predicted HR max calculated as 220 age is not suitable for the patient tested it is possible to edit the HR max value from the View Information page An example of testing protocol An example of protocol is repor...

Страница 131: ...System maintenance ...

Страница 132: ...OP REPORT SERIES European Respiratory Journal 1997 10 1928 1932 which are summarised and adapted for COSMED products as follows Accessible internal as well as external surfaces of equipment exposed to expired gas should be washed and disinfected prior to testing of subsequent patients Disinfecting should ideally be performed by heat sterilisation but gas or liquid sterilisation can be used if the ...

Страница 133: ... air 5 After cleaning the turbine check if the turbine propeller rotates freely even with a low speed air flow 6 Connect the turbine to the reader Precautions during the cleaning of the turbine 1 Do not expose the turbine to high heat and do not put it under running water 2 Do not ever dip the optoelectronic reader in any kind of solution the liquid infiltration would damage the internal circuit 3...

Страница 134: ...134 Quark PFT User Manual ...

Страница 135: ... crowded or smoky places If saliva is entered in the tube replace it immediately because it lost its functions Periodically grease the o ring on the connector in order to simplify the flowmeter connection Replace it every 100 test 6 month Inspections The equipment requires easy inspections to be carried out in order to assure a proper electrical and mechanical safety level in the years These inspe...

Страница 136: ...te Be careful to use proper fuses A 680 013 630 Time Lag Fuses 5x20 250V T 630 mA for 220 240V supply A 680 024 125 Time Lag Fuses 5x20 250V T 1 25A for 100 120V supply Select the proper power supply voltage The power supply voltage can be changed in the following way 1 Open the power supply cover using a screwdriver 2 Rotate the voltage selector in order to read the desired value ...

Страница 137: ...Appendix ...

Страница 138: ...imitation any and all warranties of merchantability and or fitness for a particular purpose COSMED shall not be liable for special indirect and or consequential damages nor for damages of any kind arising from the use of any COSMED s products whether said products are used alone or in combination with other products or substances Determination of the suitability of any of COSMED s product s furnis...

Страница 139: ...on for resent i e Resent for repair In case you should send the system for repair please contact the nearest service centre or contact COSMED at the following address COSMED S r l Via dei Piani di Monte Savello 37 P O Box 3 00040 Pavona di Albano Rome Italy tel 39 06 9315492 fax 39 06 9314580 E mail customersupport cosmed it For USA customers only please contact COSMED USA Inc 1808 North Halsted S...

Страница 140: ...partners also abroad in order to supply the service How your personal data are treated Your personal data will be stored in electronic format and protected at the best from destruction loss even accidental not authorized accesses not allowed treatment or use not in conformity with the purposes above listed The consent is optional but If you deny the consent we regret we cannot supply the service H...

Страница 141: ...to measure the hearth rate signal from any ECG with a pulse signal 0 5 Volts available or from the POLAR belt receiver probe Referring to the connector labelled as HEART RATE on the rear panel of the Quark PFT the pin out assignment is the following pin Signal 5 TTL input 4 GND ...

Страница 142: ...n program then pressing the button by side You might configure the following options Name identify the parameter Unit of meas unit of measurement Base line and Gain factors used to convert the acquired raw data mV into the final format according to Y mV BL Gain The value entered for gain must be multiplied by 1000 for Gain 1 enter 1000 Precision the number of decimals shown as 0 ...

Страница 143: ...hich has a slope of slightly less than 1 0 whereas the upper component has a slope steeper than 1 0 The intercept of these two slopes is the LT or AT point measured by gas exchange The increase in VCO2 in excess of that derived from aerobic metabolism must be generated from the buffering of lactic acid This is an obligatory gas exchange phenomenon seen in all subjects who exercise to work levels a...

Страница 144: ...d with at least 6 seconds of collected volume Accumulation time the maximum time allowed for volume accumulation during the VC manoeuvre should be at least 30 seconds and at least 15 seconds during the FVC The spirometer should be store at least 8 FVC maneuvres FEV1 should be calculated by using the back extrapolation method to detect the start of the test extrapolated volume must not be higher th...

Страница 145: ...on Testing second edition 1984 pp 101 144 Note SD FEV1 FVC e FEV1 VC da ERS93 ITS Black race Reference Adult Paediatric Intermountain Thoracic Society Clinical Pulmonary Function Testing second edition 1984 pp 101 144 Note SD FEV1 FVC e FEV1 VC da ERS93 LAM Reference Adult Paediatric A survey of ventilatory capacity in Chinese subjects in Hong Kong Lam Kwok Kwong Pang Shing et Al Annals of Human B...

Страница 146: ...FVC LLN and Pred FVC 70 Restrictive abnormality moderate Pred FVC 70 and 60 Restrictive abnormality moderately severe Pred FVC 60 and 50 Restrictive abnormality severe Pred FVC 50 and 34 Restrictive abnormality very severe Pred FVC 34 Quality Control Messages Reference Spirometry in the Lung Health Study Methods and Quality Control ARRD 1991 143 1215 1223 Message Criterion Start faster VEXT 5 of t...

Страница 147: ...ssessed By a Single Slow Exhalation of Methane Acetylene and Carbon Monoxide Ramage Coleman and MacIntyre CHEST 92 1 July 1987 Gas Exchange References On line computer analysis and breath by breath graphical display of exercise function tests Beaver Wasserman Whipp JAP 34 1 128 132 1973 Measurement and analysis of gas exchange during exercise using a programmable calculator Sue Hansen Blais Wasser...

Страница 148: ...148 Quark PFT User Manual ...

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