Home

COSMED does not assume any liability for end user

Contents

1. 41 Index 3 Fixing the K4 b to the patient 42 Connecting the K4 b to the PC 4 xi serssr rae ee on 43 Connect the Portable Unit to the PC J 43 Connect the Receiver Unit to the PC J 43 Software installation ssessesssssnnnnssssnnnnnessnnnnnsssnnnnnnssnnnnnnsssnnsnnsnnne 44 Installing the software LL kk eke k 44 Run the Software Ryan 44 PC port Configuration keke keke k k 44 Software main features csssnssssssssnnnnnessnnnnnsssnnnnnnssnnnnnnssnnnsnnssnnnnnnnen 45 DIS Plays 55oi ya N k kin PNA assenanssenhenaermaen 45 TOOL Bar ai anni roca kS va se wek seke p ana pee kak k k 45 Show hide the toolbar ueeeenenneennnnn 45 Dialog windows kerkere keke k k kk kk 45 Use of the keyboard keke 45 Use of the mOUSe uE keke kek eke kk kk 45 Scroll bais s nn erahnen ME K KA a nas eo 45 O Tine helpee yara d n ebin ra Je en bl R k be P NA a QEN AN DA 45 Software version k e ek rer knee neyek aye ye K ye s eken k 45 Calibration 47 Gas calibration procedures e serrerrrereeeeeeeoeeeoee eee kece 48 Running the Calibration program E eee 48 Loshle an an leer N DD EEE AEE 48 Setting reference values LL kek keke 48 Set the reference values using the PC software 4
2. 7 1 Connector for the sampling line for resting tests or tests with VE lt 40 l min 2 Connector for the sampling line for exercise tests or tests with VE gt 40 l min 3 Inlet for patient s exhaled air 4 Connector to be closed with the proper plug supplied with the equipment 5 Outlet for patient s exhaled air 6 Little plug for closing the connectors 1 or 2 7 Fixing holes Preparing the mixing chamber for a test 1 Connect the wrinkled tube to the inlet 3 of the mixing chamber 2 Connect the turbine to the outlet 5 of the mixing chamber 3 Disconnect the sampling line from the turbine and connect it to the connector 1 for resting tests or 2 for exercise tests of the mixing chamber 4 Close the connector 2 for resting tests or 1 for exercise tests of the mixing chamber with the little plug 6 5 Close the connector 4 with the proper plug supplied with the equipment Two way non rebreathing valve description The two way non rebreathing valve is very important in order to perform the test properly It is shown in the following picture 118 K4 b User Manual 1 2 3 Valve inlet Connector for the mask Valve outlet Note be very careful in order to differentiate inlet from outlet These two are not interchangeable to guarantee proper functionality Patient s preparation Performing the test 1 2 3 Screw the mask to the connector 2 of the valve Connect the wr
3. The K4 b is intended for use in the electromagnetic environment specified below The customer or the user of the K4 b should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions Group 1 The K4 b uses RF energy only for its internal function CISPR 11 Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class B The K4 b is suitable for use in all establishments CISPR 11 including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic Emission Class A IEC 61000 3 2 Voltage Fluctuations Complies Flicker Emission TEC 61000 3 3 Guidance and manufacturer s declaration electromagnetic immunity The K4 b is intended for use in the electromagnetic environment specified below The customer or the user of the K4 b should assure that it is used in such an environment Immunity test Test level Compliance level Electromagnetic environment guidance Electrostatic 6 kV contact 6 kV contact Floors should be wood discharge ESD 8 KV air 8 kV air concrete or ceramic tile If IEC 61000 4 2 floors are covered with synthetic material the relative humidity should be at least Electrical fast 2 kV for power 2 kV for
4. 3 Note Be careful to use proper fuses A 680 023 500 Time lag fuses 5x20 250V T500mA A 680 013 630 Time lag fuses 5x20 250V T630mA Chapter 12 System maintenance 147 148 K4 b User Manual Conformity declaration 150 K4 b User Manual Manufacturer COSMED S r l Address Via dei Piani di Monte Savello 37 00040 Pavona di Albano Laziale RM ITALY phone 39 06 9315492 fax 39 06 93 14580 manufacturer of the following equipment K4 b declares under his sole responsibility that e the above listed equipment comply with the essential requirements of the Annex I of the Medical Device Directive 93 42 EEC e are classified in Class IIa e their design manufacturing and final checks are performed according the Cosmed s Quality System conform to ISO 9001 2000 and ISO13485 2003 Norms certified by CERMET certificates nr 387 A and 387 M e are CE marked according to the Medical Device Directive 93 42 EEC and certified by CERMET certificate nr MED 9811 The equipment conform with the following specifications Safety CEI 62 5 IEC 60601 1 EN 60601 1 EMC EN 60601 1 2 Service Warranty Warranty and limitation of liability COSMED provides a one 1 year limited warranty from the date of the original sale of COSMED products All COSMED products are guaranteed to be free from defect upon shipment COSMED s liability for products covered by this warranty is limited exclusively to replaceme
5. In addition to the Operating sequence of this mode you must carry out the following operation 1 Connect the Oximeter module to the Portable Unit plugging phone jack into the RS232 port at the bottom of the PU 2 Go to the K4b control panel and select Oximeter like External device connected by choosing Settings than External device and press Enter x 3 Enable the Oximeter option by moving the sign on Oximeter and press Enter to confirm settings 4 Positioning Finger or Ear Clip on the patient and fix well the cable with Velcro stripes on the harness to minimize motion artifact To monitoring in real time SpO value during Telemetry Mode Transmission or as soon as test has been stored or downloaded go to the PC software select Parameters to view Test execution real time or Parameters to view Test visualization after download from the Options menu and select SpO parameter Chapter 11 External devices 141 142 K4 b User Manual System maintenance All service operations which are not specified in this user manual should be performed by qualified personnel in accordance with the service handbook to be required to the manufacturer Rubber mouthpieces face masks breathing valve and the other parts are not shipped sterile They should be disinfected before using according to the following instructions All materials used in the construction of the K4 b are non toxic and pose no safety risk to the patient
6. ar PC Serial plug Connect the Receiver Unit to the PC Connect the telemetry module to a serial port available in the PC Be sure to set the K4 b software to the proper serial port for the transmission Serial Connection lt gt gt AM K4 serial Sa PC Serial plug Chapter 3 Installation 43 Software installation Note The software can be installed on Windows XP or Vista It will not work on any previous versions of Windows The software consists of two programs a spirometry program uses a green CD labelled PFT option and the program for ergometry uses a blue CD labelled CPET The programs share the same archive and system calibration program One or both software programs may need to be installed depending on the device configuration Installing the software Run the software Note The software is copyright protected and should be installed only from the original disk 1 Insert the installation CD into the CD ROM drive 2 The installation will begin automatically If the disc does not start automatically you will need to run Setup exe 3 Follow the instructions given by the dialog boxes to complete the installation 4 When the installation is finished the program will alert you that the installation has been successfully completed Note If both programs are installed the directory for the CPET software should be the same as the PFT directory default is C
7. no one Protocol no one M Other data Workspace User 1 v Details k Cancel nn Diaw pe 3 Type the patient information select a protocol from the list and an ergometer if you are going to carry out a test with an ergometer 4 Chose Other Data if you want to insert other important informationon the the you are going to perform Execute Test Other Data x VO2max ml jn UN g day 0 0 Eve 1 0 00 VD ml fo Cancel FEV1 11 0 00 BH 2 50 MVV l min 0 0 RH fluss amp 100 1C jl 0 00 T fluss C 34 User 1 0 00 Marker User 2 0 00 Distance jn User a n nn Un meas 5 Select the workspace you would like to see during the test it can be also changed during test and be sure that option box Telemetry is disabled since the transmission will be done by serial cable Press OK button to start acquisition 6 The software displays the data according to the selected workspace Check some breaths and press F2 to start testing Stop the test To end the test press F3 press OK in the following dialogue box to confirm the end of the test All data will be automatically saved on the Hard disk Anyway test is stored on the memory of the portable unit as well Exercise testing patient s database The exercise testing software uses a different interface for presenting patient information The patient database allows to e Enter a new patient e Find pat
8. Enable transmission 1 Go to the K4 b control panel verify that transmission is enabled by choosing Settings On Off Transmitter and press Enter 2 Enable the transmission by moving the sign on Transmit On and press Enter to confirm settings Enter new patient 1 Connect K4 b to the subject 2 Go to the K4 b control panel and choose Patient s data from Test menu 1 Patient s data 3 Move the cursor among fields with the Enter key and use the Up and Down keys to modify values xxx A xx H xxx W xxx S M HR xxx The fields are shown in the following order patient ID A age in years H height cm or inch W weight kg or Lbs S sex M or F HR HR max 64 K4 b User Manua 4 The HR Max is automatically calculated by the formula 220 age however it can be also changed according to physician experience and patient medical history By confirming the HR rate value all the patient data are automatically saved Enable reception on PC 1 Run K4 b software 2 Open patient data dialog box select or type a new name and press OK to confirm The name of the selected patient will appear in the status bar of the software 3 Choose Execute test from the Test menu r Mode i EN Height cm E r Weight Kg 80 0 C ECG C Gas ECG Rest ECG T Telemetry L Protocat Other data Cancel Dessen ps tane 4 Type the patient information select a protocol from the l
9. Enter new patient 1 Connect K4 b to the subject 2 Go to the K4 b control panel and choose Patient s data from Test menu 1 Patient s data 3 Move the cursor among fields with the Enter key and use the Up and Down keys to modify values xxx A xx H xxx W xxx S M HR xxx The fields are shown in the following order patient ID A age in years H height cm or inch W weight kg or Lbs S sex M or F HR HR max 4 The HR Max is automatically calculated by the formula 220 age however it can be also changed according to physician experience and patient medical history By confirming the HR rate value all the patient data are automatically saved Calibrate and start the test 1 Remove the sampling plug from the mask and put the tube far from expired gas concentrations 2 On the Patient s Data menu scroll down the menu and select Start Test from the main menu and press Enter to confirm 3 The message Insert relative humidity will be visualized type the correct value and press Enter Insert relative humidity HR xx 4 The K4 b runs automatically the Room Air calibration The message Do not breath near the sampling line appears Wait for few seconds until the message Calibration done will appear together with a double beep sound Do not breath 02 20 7 C02 0 4 5 Connect the sampling plug to the optoelectronic reader Some values Heart Rate R VO VCOs will be shown a
10. To change setting move the switch on the new voltage by using a small screwdriver or a pen Turn the Unit on 1 Connect the Charger Unit to the main plug 2 Turn on the Unit by pressing the orange power switch Charge the batteries 1 Insert the batteries into the places on the top of the unit as shown in the illustration below 2 The small green LED placed on the front panel warns the charge in progress The battery is charged when the light signal placed on the front panel of the Charger Unit starts blinking Charger Unit CU Battery Note USA and Japan versions have not the antenna connector on the battery 36 K4 b User Manual Portable Unit Battery low It is recommended to charge batteries before each test When the batteries are low the warning message is prompted on the PU by two beeps for an half charged battery and three beeps for a complete discharged battery As soon as the message appears you must change batteries immediately since the system has only few minutes of endurance still available The system allows to change the battery during testing as well During the test it is possible to monitor the battery status in real time by selecting Information from View menu The PU can be supplied either by the Charger Unit or by rechargeable batteries It is recommended during Warm up to supply it exclusively by the Charger Unit time in order to save the battery used normally during the test Th
11. vco2 z ft More N Mere NOP ore N v Mere NZIV yT M no graph M VE More N8IV jR M no graph M t M Hore NIM Pet02 Peco2 ft More N 10T Ip A no graph A K HETE N Re A no graph BJ zj More N 12 ni El TT no grapn BJ T zj Porz Cancel Restore 2 Select parameters to be printed K4 b allows 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 the sheet 3 Press OK to confirm the selected configuration Customise the printout header 1 Choose Printout header from the Options menu 2 On the Report Header dialog box type the text of the header 3 To insert an image click the Logo button An image editor will be opened draw the own logo and close the image editor to save changes 4 Press OK to save the Printout header Electronic reports pdf If an Adobe PDF writer Printer Driver is 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 possi
12. 108 Calibrations del DD gr DD 108 How to prepare the canopy and the patient 108 Replacement of the power plug E 108 Connecting the Cano y u eee 108 8 K4 b User Manual How to prepare the patient 109 Performing the teSt AEL kek eke keke 109 Viewing the test 2 22 20 Ban RE EDIN Ren ewe d k nies 110 How to modify the average interval 110 Penne eds hese A Seb sk ka asia 351a ye RA B kas s ak Feb ew ayak 110 Sub maximal Exercise Testing 111 r fi O Cl CELO Di si 44 3 5545445455555450 040 aa suk se b w ne a Waw EWE e a resul Se Wa n ke k s k k 112 Pre test screening s i Pir 2 N LA ak nln 112 Sub maximal exercise testing cssccssscccssccssssccssscccssscossscosees 113 Considerations with sub maximal exercise testing 113 STA R g wei ker a ss d S kre e yek k ea nee 114 Test termination u keke keke kek k k k k 114 Considerations for accur cy cccssscrssscccsccrsssccssscccsssccsscosesscoees 115 Performing the test sisccsccecsccssccesecescestocssecesessceeseoesecesecconssecasseseuseses 116 An example of testing DIOtOCO L ee 116 The mixing chamber 117 The mixing ChAMbE L sccccsscccssscccssccssssccssscccsssccssscccssscossscoeees 118 OV ERVICW 355550351 KU ae en e4 hen MA Ke N N
13. The O and CO analysers are temperature controlled and the internal pressure and expired flow are monitored for an higher reliability if the measurements The K4 b uses Nafion Permapure which is a semipermeable capillary tube capable of removing the humidity in excess without altering the gas concentrations The analysers calibration is automatic and shows both graphically and numerically the flow and concentration signals and the accuracy of the baseline gain The PC software running on Windows allows the user to manage data stored in the Portable Unit or transmitted to PC Here following a list of the main features available e Test data management e Viewing data in table and graphic form e Automatic and manual detection of anaerobic threshold modified V slope method e On line data presentation during tests e Advanced data elaboration filtering smoothing built in spread sheet features e Os Kinetics O deficit O debt and time constant in both rising and falling edge of a constant load exercise test e Flow Volume loops during the test and overlapped on the rest FVC e Realtime display of the O and CO waveforms during the test e Control of any ergometer provided with a RS232 interface e Custom fittings linear and exponential e Spirometry FVC VC IVC MVV e File exporting in three different formats Lotus 123 Excel ASCII e Automatic detection of the Steady State e Adding param
14. Close First name TEST rt Be Do 4 To download a test you must link it to an existing patient file Choose Find and then List to select an existing patient If the patient is new than select Find and then New fill in the fields and press OK to confirm 5 Select the test to link by using First Previous Next and Last buttons and press Download to confirm your choice and to store the test on the Hard Disk You can use the Preview button to see some data and graph of the test in order to find out the proper one Chapter 5 Operating modes 63 Telemetry Data Transmission Mode Note USA and Japan In case you need to monitor in real time the test you can use the Telemetry Data versions have the items 3 Transmission module that is provided by COSMED as an option The transmission and 5 slightly different range can reach 800 m allowing to monitor exercise testing in the field To use this because of the antenna placement option you need a personal computer to connect the receiver unit Mask flowmeter Heart rate belt Rechargeable battery antenna Harness K4 b Unit HR probe Power cable antenna Receiver unit RS232 cable 10 Personal computer RENNER K dk a Operating sequence Warming up the system Warm up the K4 b for 45 minutes before testing or calibrating Connect the receiver unit to the PC Connect the receiver unit to PC with the serial cable provided in the standard packaging
15. K4 b User Manual Spirometry patient s database ig Note after having deleted a record patient visit or test it is recommended to reorganize the archive in order to free disk space The Patients database consists of a Patient Card a Visit Card and a Test Card in which are listed all tests performed by the patient Select Archive Navigator from the File menu or press the button by side The Archive Navigator x Patient Card Tests to Display mo PP r 09 10 1995 FVC FYC Name 1001 Last 1001 GE o 1001 Birth 0170171975 m 4 41 Visit Card J PEF a IP gt JB Date 0971071995 X Je 7 e e a a Ez Height cm 180 Weight Ka 70 Age 20 Drug DRUG No Yes Ex Y 0 Cig Da jo aa ar Diag Borderline Obstruction Description Quality Control Diagnosis a Blow out longer FET100 lt 6 sec chec Notes 3 Patient Card It collects all the information of a patient first name last name date of birth which remain the same for each visit For each patient there is only one Patient Card which is created the first time the Patient performs a test r Smoke To move within the database use the following buttons Move to the first patient in the archive Move to the previous patient in the archive Move to the next patient in the archive Move to the last patient in the archive Find a patient in the archive Enter a new patient in the archive Delete
16. PFTSUITE 1 In the Windows Start menu open the Program Group in which the software was installed 2 Click the CPET or the PFTSuite icon PC port configuration 44 K4 b User Manual The first time the software is used it is necessary to configure the communication port with the PC USB COM1 COM2 For further details see the chapter Database management Software main features Display Tool bar Dialog windows Scroll bars On line help Software version The program may contain several windows The active window is highlighted with a different colour of the caption Some functions of the program are active window sensitive Print right key ofthe mouse Many of the functions that may be selected from the menu can be activated more rapidly by clicking with the mouse on the corresponding icon in the tool bar Positioning the mouse cursor on one of the buttons of the toolbar if the option Hints is enabled the description of the corresponding function is shown in a label Show hide the toolbar Select Toolbar from Options menu in order to show or hide the toolbar The typical operating environment of Microsoft Windows is the Dialog box This window is provided with a series of fields in which input the information Use of the keyboard e To move the cursor among fields press the Tab key until you reach the desired field e Press the Enter key to confirm the information input on the dialog box
17. as per the picture below paying attention of not wetting the sampling tube NO OK 3 Rinse the turbine in a vessel filled of clean water shaking gently to remove the disinfectant do not clean the turbine by putting it under running water 4 Let it dry to air 5 After cleaning the turbine check if the turbine propeller rotates freely even with a low speed air flow Precautions during the cleaning of the turbine e Do not expose the turbine to high heat and do not put it under direct water spout e Do not wet neither the sampling tube nor the connector on the other end of the cable e Do not use alcoholic solutions to clean the turbine Two way non rebreathing valve cleaning option Refer to the indications reported in the sheet shipped together with the valve The valve must be disinfected after each usage on a patient Mixing chamber cleaning and disinfection option Before disinfecting the mixing chamber disassemble it unscrewing the screws in the top cover Note do not use alcohol solvents or other abrasive substances for cleaning the mixing chamber For disinfecting the mixing chamber plunge each part in the disinfecting solution for 20 minutes Rinse and wipe After the cleaning carefully close the mixing chamber Permapure maintenance e Do not bend squash or deform it 146 K4 b User Manual Inspections Replace the fuses e Do not keep it in open air if not used especially in crowd
18. ml min l min Parameter Oxygen Uptake Carbon Dioxide production Tidal Volume End Tidal O2 End Tidal CO2 Respiratory Quotient Ventilation Heart Rate Cardiac output Anaerobic Threshold Ventilation Stroke volume Respiratory Frequency Averaged expiratory concentration of O2 e CO ventilatory equivalent for O2 ventilatory equivalent for CO2 Oxygen pulse VO2 per Kg time breaths Vd Vt ratio arterial PCO2 estimated Delta PaCO2 PetCO2 Parameter Energy Expenditure Energy Expenditure Body surface area Energy Expenditure pro Kg Fats Carbohydrate Protein Fat Carbohydrate Protein Respiratory quotient not protein Description Lactate Anaerobic Threshold STPD Respiratory Quotient LT Time LT CO2 output LT STPD Ventilation LT BTPS O2 Kinetics HR Parameter O deficit O debt Spirometry Tests option bpm UM Vm l m Heart Rate LT Calculation VO2 work tau VO2 work tau FVC Forced Vital Capacity Symbol FVC FEV1 FEV1 FVC PEF FEV0 5 FEV6 FEV1 FEV6 FEV6 FVC Best FVC Best FEV1 Best PEF Vmax25 Vmax50 Vmax75 FEF25 75 FET100 FEV2 FEV3 FEV2 FVC FEV3 FVC FEV1 VC FEF50 75 FEF75 85 FEFO 2 1 2 FiVC FiF25 75 FiV1 PIF VEXT PEFT UM 1 1 l sec l sec l sec l sec l sec l sec l sec l sec l sec L l sec l sec l sec ml msec Parameter Forced Expiratory Vital Capacity Forced Expiratory
19. or if the orbital data is obsolete it may take 5 0 minutes to achieve a navigation solution The GPS Autolocate feature is capable of automatically determining a navigation solution without intervention from the user This procedure may be required if one of the following situations occurs 1 Transportation over distances further than 1500 kilometers 2 Failure of the internal memory battery without system standby power 3 Stored date time off by more than 30 minutes The GPS will automatically update satellite orbital data as it operates The intelligence ofthe GPS combined with its hardware capability allows these data to be collected and stored without intervention from the host system Initialize the GPS 1 If the receiver is not operated for a period of six 6 months or more the unit will search the sky in order to collect satellite orbital information This process is fully automatic and under normal circumstances will take 3 4 minutes to achieve a navigation solution 2 Ifthe memory backup battery of the GPS fails the receiver will search the sky as described above Should the memory battery discharge the unit needs to be powered on for several hours to insure a sufficient recharge to maintain several months of clock operation and memory storage 3 If the initial data is significantly inaccurate the receiver perform an operation known as AutoLocate This procedure is fully automatic and under normal circums
20. 16 15 Tue _0K_ Cance 2 Fit a graph with a linear regression 1 Make active the graph window any Y vs any X graph 2 Right click and select Fitting 3 Choose Linear in the type combo box 4 Select the first point X1 moving the mouse on the desired place 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 Insert initial factors for the formula Y B A 1 expf t Tau J A IE IF Constraint B 0 93 IV Constraint Tau 40 0 Constraint Max attempts foo Cancel Make active the graph window any Y vs any X graph Right click and select Fitting Choose Mono exponential in the type combo box 1 2 3 4 Select the first point X1 moving the mouse on the desired place 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 Enter if necessary the initial values of A B and TAU these are the values from which the iterative algorithm starts in order to reach the best values the closer are the initial coefficients to the best ones the higher is the possibility to reach the best fit 7 Press OK to confirm Chapter 7 Exercise Te
21. 41 43 130 LONG 12 36 701 5 With the use of Up and Down key verify that the displayed altitude value Alt is different from zero In case displayed altitude value is fixed on zero please be sure that the antenna receiver is well plugged in the sky is visible and wait until the Altitude value is shown Chapter 11 External devices 139 140 K4 b User Manual Monitoring GPS parameters in real time To monitor in real time GPS parameters during Telemetry Mode Transmission or as soon as test has been stored or downloaded go to the PC software and select Parameters to view Test execution real time or Parameters to view Test visualization after download from the Options menu Select the following parameters Velocity GPS Vel m sec Distance GPS Dist meters incremented during exercise phases only Latitude Lat DD MM MMM N S Longitude Long DD MM MMM E W Altitude Alt meters Only when test has been stored or downloaded you can verify the Graphical path automatically drawn on a scaled X Y plane oriented to North selecting on the PC software Visualization and GPS track Note Distance is automatically calculated only during the exercise phases Pulse Oximeter option Operating Sequence The oximeter option is useful to monitor SpO value during the test Test with this option can be carried out with K4b system in Holter Data Record or Telemetry Data Transmission mode only
22. AR Kv E en et nek Hek 118 Preparing the mixing chamber for a test 118 Two way non rebreathing valve description 118 Patient s preparation keke kek keke nen 119 Performing the teSt AEL kek ekere kek keke 119 Spirometry 121 Setting spirometry options cccccccssccssccssccssccssccsscosscesscosscoesces 122 SPITOME UY 7 24 sun gg 122 Automatic Interpretation L eee 122 Qu ality Ccontrol lt s isxyda kay den ea eker r ee keke eke ek 122 Parameters mana ge ist dest d yi yola e kaka xoy ha daha behoy adan 123 Predicted values manager u keke 123 Pr dict eds set RMN DM rr 123 Set the current predicted E ee 124 Formula definition keke keke 124 Pagese buann eene DD a 125 Spirometry teStS essesseoseosecsecsecsscssscosessecsessessesseosessessesssosessesseo 126 Forced Vital Capacity pre sesssesssecssessseossecosecsscssecssesssesssesoseoso 127 RecommendationS u eker k k k keke 127 Perform a FVC pre fe Sin issa na ak Ha Kesin xanke Ha Eke LEE nennen 127 Test encouragement i i yiy kns ki ekir ned kik Gulka ki He k kk k 127 Perform the FVC test with the encouragement 128 Slow Vital Capacity ccsccossscsssocosnsscossssocsesacestsonsssccsscdsasssocsssssoses 129 Perform a SV test anne avi ah ie ma 129 Maximum V
23. Critical Care A Training Handbook Donald C Zavala Anaerobic threshold modified V Slope O kinetics 156 K4 b User Manual The break point or intercept of the two slopes can be selected by a computer program that defines the VO2 above which VCO2 increases faster than VO2 without hyperventilation During an incremental exercise above the Lactate Threshold the net increase in lactic acid production results in an acceleration of the rate of increase in VCO2 relative to VO2 When these variables are plotted against each other squared graph without recovery points the relationship is composed of two apparently linear components the lower of which 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 above their LT This technique is referred to as the V Slope method OVS Original V Slope method A new method for detecting anaerobic threshold by gas exchange Beaver Wasswrman Whipp JAP 1986 60 2020 2027 MVS Modified V Slope method Metabolic acidosis during exercise in patients with chronic obstructive pulmonary disease Sue Wasserman CHEST 1988 94 931 938 Delayed Kinetics of V
24. K4 b on or off press the on off key Connect the rechargeable battery Plug the power supply cable into the battery socket as shown in the following illustration Heart rate probe Power supply cable Power supply cable 1 2 38 K4 b User Manual 1 1 t International telemetric version USA and Japan Telemetric version Sometimes you might need to change the battery during the test To do this you must change the battery in the shorter time possible The Portable Unit does not transmit data while it is not powered Warning During testing make sure to change the battery as fast as possible since a long time could compromise the reliability of measurements Receiver Unit Optionally the K4 b is provided with a transmitter board located inside the K4 b unit and a Receiver Unit to monitor on line exercise tests performed either in the field or in the lab All data measured by the K4 b are transmitted breath by breath to the Receiver Unit in real time The RU illustrated below must be connected to a Personal Computer with any RS 232 serial port to display data on line in the management software The transmission range is 800 meters in open field However during transmission the test is stored in the memory of the K4 b Unit so that in case of transmission interference no data is lost 6V DC for battery and main power supply Battery Level Indicator On Off Switch Serial Port RS 232
25. P15 Dose that causes a 15 fall of FEV1 P20 Dose that causes a 20 fall of FEV1 The representative plot is the Dose response curve showing the percentage variation of FEV1 versus the Drug dose in logarithmic scale The program assumes as the baseline test the best FVC pre carried out during the today s visit You can change the reference pre test editing the Post test The name of the drug its quantity and its unit of measurement can be typed immediately before any FVC post manoeuvre manual protocol or can be stored in a database of bronchoprovocation File Bronchial Provocation protocols Database Chapter 10 Spirometry 131 Perform the test START STOP ABORT Ie BACK During 1st step only select Protocol from the Test menu and choose the name of the bronchoprovocation protocol that you are going to use manual protocol if you want to type the information about the agent before any manoeuvre 1 Select FVC post from the Test menu 2 Select an existing protocol or click on manual protocol and wait the green leds turned on 3 Press F2 or the button by side to start the test Press F3 or the button by side to achieve the test ao In order to visualise the V t graph and the main parameters press the follow buttons view Flow Volume graph view data of the test view bronchial provocation response Press Alt F3 to stop the acquisition discarding the results 7 R
26. PC through the RS232 serial port and all tasks exactly like any conventional laboratory device Anyway tests are stored on the memory of the portable unit as well 60 K4 b User Manual Portable Unit User Interface diagram unctions Memory Room Air Status Calibration View Reference Gas Test list Calibration Turbine Calibration O CO Delay Calibration On Off Transmitter Patient s Data Enable Disable Warnings Set Date and Time Units of Measurement Restore Factory Settings Set Calibr Pred Values Set Calibr Factors Control Panel GPS Autolocate Warm up time Setting External Device Turbine 18 28 Altitude Setting Version Chapter 5 Operating modes 61 Holter Data Recorder Mode www Note USA and Japan versions have the items 3 and 5 slightly different because of the antenna placement Operating sequence 62 K4 b User Manua It is ideal operating modes if you need to test a patient difficult to monitor by Telemetry i e climbing long distances races etc The memory capacity of the K4 b is able to store data up to 16 thousands breaths The system saves data for each breath hence time storing capacity depends on the respiratory frequency Mask flowmeter Heart rate belt Rechargeable battery Harness K4 b Unit HR probe Power cable A Or SP Sea Warming up the system Warm up the K4 b for 45 minutes before testing or calibrating
27. Pred FEV1 lt 60 and gt 50 Obstructive abnormality severe Pred FEV1 lt 50 and gt 34 Obstructive abnormality very severe Pred FEV1 lt 34 Restrictive abnormality mild FVC lt LLN and Pred FVC gt 70 Restrictive abnormality moderate Pred FVC lt 70 and gt 60 Restrictive abnormality moderately severe Pred FVC lt 60 and gt 50 Restrictive abnormality severe Pred FVC lt 50 and gt 34 Restrictive abnormality very severe Pred FVC lt 34 Quality Control Messages Reference Spirometry in the Lung Health Study Methods and Quality Control ARRD 1991 143 1215 1223 Chapter 13 Appendix 159 160 K4 b User Manual Message Start faster Blast out harder Avoid coughing Blow out longer Blow out more air Blow out harder Take a deeper breath Blow out faster That was a good test FVC reproducible FEV1 reproducible PEF reproducible MVV time too short Criterion VEXT gt 5 ofthe FVC and gt 150ml PEFT gt 120 msec 50 drop in the flow in first second FET100 lt 6 sec flow gt 0 21 s within 20 ml of FVC dPEF lt 10 dFVC lt 200ml and 5 best FVC dFEV1 lt 200ml and 5 FEV1 No errors diff 2 max FVC within 0 21 diff 2 max FEV1 within 0 21 diff 2 max PEF within 10 MVV time less than 12 sec References Gas Exchange References On line computer analysis and breath by breath graphical display of exercise function tests Beaver Wasserman Whipp JAP 34 1 128 132 197
28. Ureic Nitrogen value NU 2 picture 6 Confirm and start the test by pressing OK pi Selecting RMR the system set automatically the following options e Data acquisition with a 30 seconds average e RMR protocol which is 5 minutes discarded 10 minutes with data acquisition of which the software will make an average at the end of the test automatic end of the test after the 16 minute e Selection of the RMR workspace windows placement The test is fully automatic the software will stop it and save the data at the end of the 16 minute The real time view is as shown in the following picture PFT Ergo InfoCenter BEIE File Test View Events ECG Window 2 Demo EES a ee e 2 GRAPH le amp ach ee VO2VCOM BOND J tost n 8 olx VE HRA BOND J test u 8 nj x vo2 V02 ml min VCOZ nl min VE 1 min HR bpm er 00 00 01 00 02 00 03 00 04 00 05 00 06 00 07 00 Bil BOND J test n t RE VE vo2 vcoz VO2 Kg R Fe0O2 Feco2 HR VO2 HR Loadi Ti Ttot VD VT hh mm ss b min l min ml min ml min ml min Kg bpm ml bpm ME a 00 00 31 15 0 10 6 386 321 5 08 0 83 16 57 3 78 72 ay emn gt e er ee Pb mmHg 741 RH 56 Temp C 25 Mixing chamber 00 30 JR star 3 O W SA W BW By Espora risorse K Posta in arrivo m E QPFT chapttt co ELPrr Ergo E asc Paint Shop Pro 0
29. Volume in 1 sec FEVI1 as a percentage of FVC Peak Expiratory Flow Forced Expiratory Volume in 0 5 sec Forced Expiratory Volume in 6 sec FEV as a percentage of FEV6 FEV6 as a percentage of FVC Best Forced Expiratory Vital Capacity Best Forced Expiratory Volume in 1 sec Best Peak Expiratory Flow Expiratory Flow when 75 of the FVC remains to be exhaled Expiratory Flow when 50 of the FVC remains to be exhaled Expiratory Flow when 25 of the FVC remains to be exhaled Mid exp flow between 25 75 F VC Forced expiratory time Forced Expiratory Volume in 2 sec Forced Expiratory Volume in 3 sec FEV2 as a percentage of FVC FEV3 as a percentage of FVC Tiffenau index Mid exp flow between 50 75 F VC Mid exp flow between 75 85 F VC Mid exp flow between 0 2 1 1 2 1 Inspiratory Forced Vital Capacity Forced mid inspiratory flow Forced Inspiratory Volume in 1 sec Peak Inspiratory Flow Extrapolated Volume back extrapolation Time to PEF 10 90 VC IVC Slow Vital Capacity and Ventilatory pattern Symbol EVC IVC ERV IRV IC UM ale fete e Parameter Expiratory Vital Capacity Inspiratory Vital Capacity Expiratory Reserve Volume Inspiratory Reserve Volume Inspiratory Capacity Chapter 2 Measurements 33 34 K4 b User Manual Ttot Ti Ttot Vt ti l min Expiratory Minute Ventilation 1 Tidal Volume l min Respiratory Frequency sec Duration of Inspiration sec Duration of Expiration sec Duration of Total
30. 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 furnished hereunder for the use contemplated by Buyer is the sole risk and responsibility of Buyer and COSMED has no responsibility in connection therewith Buyer assumes all risks and liabilities for loss damage or injury to persons or property of Buyer or others arising out of the use or possession of COSMED s products The limited warranty as herein above set forth shall not be enlarged diminished modified or affected by and no obligation or liability shall arise or grow out of the renderings of technical advice or service by COSMED its agents or employees in connection with Buyer s order or use of the product s furnished hereunder Return goods policy for warranty or non warranty repair Goods shipped to COSMED for repair are subject to the following conditions 1 Goods may only be returned after your receipt of a Service Return Number SRN from COSMED S r l 2 Place your SRN report and Packing List outside the package 3 Goods returned must be shipped with freight and insurance charges prepaid Collect shipments will not be accepted 4 The following list of goods are not el
31. breathing cycle _ Ti Ttot ratio l sec Vt ti ratio MVV Maximum Voluntary Ventilation Symbol MVV MVt MRf MVVt UM Parameter l min Maximum Voluntary Ventilation 1 Tidal Volume during MVV 1 min Maximum Respiratory frequency sec MVV duration time Bronchoprovocation Response Symbol FallFEV1 FallVmax50 P10 P15 P20 UM Parameter Fall in FEV1 from baseline or post diluent Fall in Vmax50 from baseline or post diluent Provocative dose causing FEV to fall 10 from baseline Provocative dose causing FEV to fall 15 from baseline Provocative dose causing FEV to fall 20 from baseline Installation sequence Before starting operating with the system make sure to meet the environmental and operational conditions reported in Chapter 1 Battery Charger Unit Plug for car charging adapter Voltage switch PU power supply plug Main plug ON OFF switch The Battery Charger Unit allows the following functions e Charge 3 rechargeable batteries simultaneously e Charge batteries by means of the car lighter plug e Supply the K4 b Portable Unit directly by the main power Check voltage TYY PENEI ee The Battery Charger Unit is provided with a switch that allows to change the voltage arning Before turning the f Battery Charger Unit on check according to the following values the voltage switch selected e 115V 50 60 Hz 100V 120V meets vour main voltaae e 220V 50 60 Hz 200V 240V
32. calibration has to be performed with very slow manoeuvres each complete manoeuvre in about 10 15 seconds to obtain the best accuracy Chapter 4 Calibration 57 Checking the system signals The control panel The Control Panel which can be activated from the Calibration Control panel menu item is a useful tool to check the main hardware functions of K4 b By using the controls on Control Panel you are able to do the following 1 Reading 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 Control panel E 8 0r ele AX ena fy 02 mv 3863 aL Tiinaa r jv C02 m 102 bient temp m 267 Ta eal ll Messages cp Vv Internal temp m 399 jv Barometric press mV 3712 v Analyzers press m 3566 Vv Battery voltage mY 3800 Vv Heart rate msec 678 IV Turbine Flow ml sec 312 IV Turbine Volume ml 401 eb Using the control panel lect all Deselect all mv ee Flowmeter Buzzer a channels Signal refresh play on off on off time PA x ge CO2 Trimmer 68 Ei a edit parameters Sampling Transmitter name unit pump on off on off Digital CO trimmer 58 K4 b User Manual K4 b Operating modes K4 b is a versatile system You can use it in the field or in the lab withou
33. contraindicationS keke 17 Contraindications for Exercise testing e 17 Environmental condition of use hrhneerereeeeeeeeeeeeeeeeee 18 EMO 556 yus e c wa na nie dee keke eka ku ba kU WERGE keke ke e Wen ehe re d Wene VEBE ENE VERA AN 19 Safety and CONnforimity ccccsscccssscccsssccsssccssssccssscccssscsssscscsscosees 22 Sad DD DD r n mine 22 EMG 6 66 2 eaten neh A 22 T lemetr y aven n nan Kn an ka s ae a ci Mn irmehsen 22 Quality ASSUTATIC L Eke keke kek kk kek ke 22 Medical Device Directive CE mark 22 FCC only USA Version keke k 22 Keynotes lt lt s n seyan da aken ewe kaw z sae san e awe soises kan ke a Va we k w Rewa k We Wek V NA 23 Typographic keynotesS keke ek k k k 23 Graphic a0 SNN DD mm 23 System overVvieW s skk u kisksk k kieuan k n nukde k ne d n k da nuk n k na d n k da nun n kan uad ken a k 24 Portable Unit PU ieaie nenn rear 24 Telemetry Data Transmission Receiver Unit RU 24 Battery Charger Unit C eee ek 24 Flowmeter ks l da Leste een atte eee ete ON AME etan 25 Gas analyser Si xe n sili ke kin ke i n dek aan len 25 PC Software DD E rrr 25 Before StcF Ti 0J i i i i54453544554 o155550 005 4405s 5se ekok 0 e seos toasoe 900
34. current patient from the archive qi E P E BB E 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 been created in different days Before carrying out any spirometric test it is necessary to create a new Visit Card or to open the today s Visit Card To move within the database use the following buttons Move to the first visit in the archive Move to the previous visit in the archive Move to the next visit in the archive Move to the last visit in the archive BEEBE Find a visit in the archive Chapter 6 Database Management 73 E Enter a new visit card in the archive x Delete current visit card from the archive Edit the current visit card Test Card It contains all the information about the test To move within the database use the following buttons x Delete current test from the archive Edit the current test Import export a Tests card Lu 2 lr he 2 Diagnosis Database 74 K4 b User Manual This function allows to import export a test card with the respective 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 proprie
35. data press F2 ANA Ey REC ORS Ka Sr ID AAA 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 F3 2 Choose Yes to end the test or No to continue View data in real time Parameters to view 80 K4 b User Manual The visualisation features and capabilities of the data and graphs are identical to the ones described in the Data management chapter Starting the test a small window will appear on the right corner displaying time bmp and if selected before the ergo protocol and trainer View graphs in real time 1 Choose Graph from the View menu 2 Follow the instructions described in data management section to edit the graphs While the test is running it is possible to choose the parameters to view 1 Select Parameters to view Test execution from the Options menu 2 Select the parameters and confirm Parameters to view x Select parameters to view Manual protocol 2 Tip pressing the Shift key while choosing the marker option will allow you to enter the label for that marker l Automatic protocol PRO Set the BPM alarm If you are using the K4 b with a treadmill without serial interface it is possible to enter manually from the PC the event the phase and the marker Enter Load and Phase 1 During the test select Load from the Events menu 2 Selec
36. example it has been set to create a filename composed by lt date of the test gt followed by lt last name gt and lt first name gt Chapter 10 Spirometry 125 Spirometry tests Note Read carefully the contraindications in Chapter 1 126 K4 b User Manual Once completed the phases of the introduction of the patient s data and the visit data it is possible to carry out the spirometric tests K4 b allows to perform the following tests Key Test FVC pre Forced Vital Capacity FVC post Forced Vital Capacity after bronchial stimulation SVC Slow Vital Capacity MVV Maximum Voluntary Ventilation Before performing any test make sure that 1 K4b is properly connected to your PC and the selected serial port COM1 COM2 corresponds to the one effectively use 2 The name shown on the status bar corresponds to the patient who is to carrying out the tests 3 The today s visit card exists Forced Vital Capacity pre FVC is a reference test to verify obstructive airflow limitations and restrictive disorders lung volume limitations To achieve good test results it is fundamental a good manoeuvre quality control messages real time plots Recommendations The main parameters measured during FVC tests are FVC Forced Vital Capacity FEV1 Forced Expiratory Volume in 1 second FEVV FVC FEV1 asa percentage of FVC PEF Peak Expiratory Flow FEF25 75 Forced mid Expiratory Flow The two repres
37. 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 same Patient with the Spirometry software and press OK It is possible to edit the Cardiac Output event in the following way 5 Select Edit from the Event menu to change the parameters measured during the steady state before the rebreathing the CO concentration at the equilibrium and the calculation method It s a particular feature with which the user can check and save some parameters CO output Oz concentration and volumes in Ascii file format in a archive apart at a sampling rate of 25 Hz Chapter 7 Exercise Testing 99 100 K4 b User Manual Save Raw data 1 2 3 4 During the test choose Event from Events menu Select Raw Data from the list On the save data box give a name to the file and select the destination folder To stop saving Raw data press the stop icon or press F3 on the keyboard Metabolism Metabolism can be understood as the conversion by the human body between food and accumulated fat into energy The energy is used by the body to maintain constant temperature to move and to make all the organ function Measure of metabolism is calories cal Total Metabolic Rate The total metabolic rate are the total calories that the human body needs in order to actuate the daily functional activities Resting Metabolic Rate RMR Resting Metaboli
38. is necessary to disinfect periodically the turbine for sanitary measures or and for the Warning Do not use correct device function alcoholic solutions for the The disinfecting procedure is easy and may be effected every time the user needs keeping attention to some precautions turbine otherwise there can be damages to the plastic material Turbine Optoelectronic reader Take out the turbine 2 Dip it ina disinfectant solution non alcoholic based for about 20 minutes 3 Rinse the turbine in a vessel filled of clean water shaking gently to remove the disinfectant do not clean the turbine by putting it under running water 4 Let it dry to 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 Do not use alcoholic solutions to clean the turbine Masks cleaning and disinfection The face masks should be cleaned and sterilised after each test Disassembling the different parts of the mask 1 Remove the valves from their place 2 Remove the adapter for the optoelectronic reader Cleaning the mask 1 Clean the mask with hot water and a soap solution to r
39. is possible also that your have no more hard disk space So you have to delete all the data In this case it is useful to perform the initialising Reorganise the archive 1 Select Reorganize archive from the File menu 2 Wait for the end of the operation before performing any other function Delete the archive 1 Select Initialize Archive from the File menu 2 Wait for the 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 Select Backup archive from the File menu 2 Selecting the destination path with the Browse key or press New to create a new directory Press OK to confirm 3 Inthe dialog box it will appear an estimate of the number of floppy disks you need in order to back up the archives Press OK Backup v 5 4 x Restore v 5 4 Ea r Statistics Backup to 60 files 2 Mb Restore from l f 5 0 Description Browse HEEE DK Cancel UK Cancel Restore 1 Select Restore archive from the File menu 2 On the Restore dialog box specify the drive source and press OK a dialog box will appear indicating all data of the backup processed 72
40. min 0 00 V02 ml min 0 798 1596 2395 3193 3992 0 798 1596 2395 3193 3992 VE V02 VE VC02 Parameter Values LT Max Max sa 53 t hh mm ss 00 05 30 00 11 00 50 0 48 1 48 Load Watt 30 450 20 0 a3 43 Real Load Watt 0 0 0 0 2 as Revolution RPM 0 0 0 0 O2 ml min 1217 3032 40 1 3271 32 O2 Kg ml min Kg 16 01 39 90 40 1 274 La wn 27 VCO2 ml min 1060 3991 26 5 aq hE 21 VE l min 24 7 130 7 18 9 ia T HR bpm 87 152 57 2 io i RC 0 87 1 68 51 6 54 i 5 o VOZ ml min u A fen 0 798 1596 2395 3193 3992 OK Cancel Customise graphs for the LT viewing The software allows to customise two of the three graphs for the LT visualisation 1 Choose Lactate Threshold from the Options menu 2 Choose the parameters you want to be shown on the LT window and press OK to confirm your choices 84 K4 b User Manual Fittings The purpose of the fitting function is to find the function that fits as better as possible the measured data The software allows to fit data according to 3 different functions Model Function Algorithm Available for Linear Y A X B Least squares Any Y vs any X graph Mono Exp Y A B exp t to tau Levemberg Marquardt Any Y vs Time Graph Mean value This function is available only if the active window is a single Y graph i e VO vs time or VO vs Load Fittings Selection om x1 00 00 03 wf Type i IV Add Bag 00
41. minutes warm 20 95 O and 0 03 for CO You can run this procedure either with the software or up time b for starting h directly with the Portable Unit calibration procedure Room air calibration using the PC software vvv 1 Connect the Portable Unit to the PC by the serial port Remove the sampling plug Important During from the flowmeter calibration always remove 2 Run the calibration program and choose Room air from the Calibration menu the sampling tube from the i optoelectronic reader Do 3 The message Room air calibration in progress will appear and a graph will not remove the sampling show in real time the O and CO calibration At the end of the manoeuvre the tube from the Portable Unit otherwise calibration could i j q i be affected 4 The following dialogue box will appear showing the calibration results press OK to confirm the calibration Analyzers Calibration Results Eg message Calibration done will be visualized www Caution During Room Air j Date 21701797 calibration be sure to put the Time from start up 0 06 33 sampling line far from the expired gas otherwise calibration could be affected Air temperature C AF Internal temperature C Atmospheric pressure mmHg 739 www Analyzers pressure mmHg 7a Caution Room Air calibration 5 performed in small ambients Humidity high concentration of CO affects the calibration results Oxigen r Carbon
42. other accepted guidelines see table in the following In the event of an abnormal response the test should be terminated the medical director of the facility and the individual s primary care physician notified and all specified follow up procedures performed In the event of mechanical 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 an increase in exercise intensity Excessive rise in blood pressure systolic pressure gt 260 mmHg or diastolic pressure gt 115 mmHg Signs of poor perfusion tight headedness confusion ataxia pallor cyanosis nausea or cold and clammy skin Failure of heart rate to increase with increased exercise intensity Noticeable change in heart rhythm Subject requests to stop Physical or verbal manifestations of severe fatigue Failure of the testing equipment Assuming that testing is non diagnostic and is being performed without direct physician involvement or electrocardiographic monitoring Considerations for accuracy The ability to obtain valid and reproducible results is essential to ensure that any differences between pre treatment and post treatment test
43. power Mains power quality should transient burst supply lines supply lines be that of a typical IEC 61000 4 4 1 kV for 1 kV for commercial or hospital input output lines input output lines environment Surge 1 kV differential 1 kV differential Mains power quality should IEC 61000 4 5 mode mode be that of a typical 2 kV common 2 kV common commercial or hospital mode mode environment Voltage dips short lt 5 Ur lt 5 Ur Mains power quality should interruptions and gt 95 dip in Ur gt 95 dip in Ur be that of a typical voltage variations on for 0 5 cycles for 0 5 cycles commercial or hospital power supply input 40 Uy 40 Ur environment Ifthe user ofthe lines 60 dip in Ur for 60 dip in Ur for K4 b requires continued IEC 61000 4 11 5 cycles 5 cycles operation during power mains interruptions it is 70 Ur 70 Ur gt 3 30 dip in Ur for 30 dip in Ur for ecommended that the K4 b 25 cycles 25 cycles be ali from E lt 5 Ur lt 5 Ur aid e power supply gt 95 dip in Ur gt 95 dip in Ur for 5 sec for 5 sec Power frequency 3 A m 3 A m Power frequency magnetic 50 60 Hz magnetic fields should be at levels field characteristic of a typical IEC 61000 4 8 location in a typical commercial or hospital environment Note U is the a c mains voltage prior to application of the test level Chapter 1 Getting started 19 20 K4 b User Manual Guidance and manufa
44. specifies the time range All steps applies the editing from the beginning to the end of the test Apply to Specifications Parameter specifies the reference parameter gt gt lt lt lt gt higher than higher or equal equal to lower than lower or equal different Value Formula specifies the value mathematical expression compared with the value of the specified parameter All steps do not use any selection criteria Restore the original test To cancel all the editing in the Edit Test dialog box press the Restore button confirm your choice by pressing yes Overwrite the original test To save all the editing replacing the original test with the modified one in the Edit Test dialog box press the Overwrite button confirm your choice by pressing yes Customise the desktop Smart edit Customise the display colours 1 Select Colors from Options menu 2 Select the item to be modified 3 Press Change and select the desired colour This function is useful to correct data from artefacts the noise affecting the 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 SmartSmooth Parameter no corr max corr n sill ggg sn a n Value r Execute Undo Find Fix Apply the graphical noise suppression Cancel ip 1 Make active a graph or a data w
45. to create different exercise protocols to use during the test The load of the ergometer is automatically controlled by the software that change it according to the defined protocol 94 K4 b User Manual Create a new protocol 1 Choose Real Time gt Ergom Tests Protocols from the Options menu 2 Press New and enter a name for the protocol 3 In the field Message Time type a number that means to get a message 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 to confirm 7 Press Add if you want to add a new step 8 To edit a step select it from the list and change the relative values in the Edit boxes below the list Press the Tab button to save changes 9 To delete a step highlight the step and press Delete x r Steps SH Ergometer t Speed Elevation Phase Command 00 00 02 0 0 0 1 no one Xa See l f g BA y putoo 00 02 20 10 0 0 no one Byes 3 3 aa 5 MerooeTinetrock gt oae 997 2 9 fa ew 00 04 00 35 0 0 no one x Messages 00 04 20 40 0 0 no one x IV Drive ergometer Generate Edit Add Delete IF Relative Increments Initial
46. 0 00 49 1 39 2 27 0 77 0 921 157 4 Overwrite 4 gt Test n 21 Stepn 17230 Duration 00 16 15 re Data filtering Select Filter Type xi r Filter Y C Discard invalid steps Averaging 00 24 4 fii gt o C Smoothing Points j __Cancel 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 option Averaging and type the desired value for points Ave smooth to perform an averaging of the all acquired steps This feature reduces the size of the original test 4 Press the button Filtering select the option Smoothing and type the desired value for points This feature doesn t reduce the size of the original test although it smoothes the fluctuation of data Chapter 7 Exercise Testing 89 90 K4 b User Manual Using the User fields The software is provided with three free fields in which the user may enter values coming from others devices such as lactate blood pressure etc To define the user fields 1 Choose User Fields from the Options menu 2 Type the desired text in the input fields and press OK To enter values in the user fields 1 Choose Edit test from the Test menu 2 Scroll horizontally until the fields USER 1 2 and 3 3 Enter the desired values and press OK to confirm Deleting steps This feature i
47. 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 70 3 70 7 38 100 11 70 11 70 23 33 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be determined using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Notes 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Chapter 1 Getting started 21 Safety and conformity 22 K4 b User Manual Safety IEC 601 1 1988 EN 60 601 1 1990 Find reported below the complete classification of the device e Class I type B device e Protection against water penetration IPO0 ordinary equipment unprotected against water penetration e Non sterile device e Device not suitable in the presence of flammable anaesthetics e 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 Telemetry I ETS 300 220 CEPT T R 01 04 pr ETS RES 0908 CE type conformity Transmission frequency and output power can be changed upon request according to the destination countr
48. 1 O 14 97 00 01 25 11 4 0 798 9 1 349 288 26 31 4 59 0 82 16 44 3 83 65 3 15 12 00 01 30 10 5 0 947 10 0 376 316 26 31 4 95 0 84 16 51 3 85 66 5 7 0 j 15 15 00 01 36 10 8 0 888 9 6 339 294 28 32 4 46 0 86 16 72 3 74 65 5 2 oO 15 25 00 01 42 10 8 0 917 9 9 352 309 28 32 4 63 0 87 16 73 3 77 64 5 5 O 15 35 00 01 47 10 9 0 846 9 2 323 283 28 32 4 25 0 87 16 77 3 74 64 5 0 0 15 29 00 01 53 10 9 0 848 9 2 315 274 29 33 4 15 0 87 16 86 3 61 64 4 9 0 15 63 00 01 58 10 7 0 881 9 4 329 292 28 32 4 32 0 89 16 78 3 77 64 5 1 0 15 33 00 02 04 11 0 0 761 8 4 289 249 29 33 3 80 0 86 16 86 3 61 65 4 4 O 15 51 00 02 09 10 5 0 817 8 6 286 261 30 33 3 77 0 91 16 95 3 69 64 4 4 015 62 00 02 15 11 2 0 876 9 8 320 283 30 34 4 21 0 88 17 06 3 50 65 4 9 0 15 65 00 02 20 11 1 0 907 10 1 337 286 29 35 4 44 0 84 16 97 3 46 66 5 1 0 15 69 00 02 25 10 9 0 795 8 6 275 246 31 35 3 62 0 89 17 14 3 46 65 4 2 O 15 68 00 02 31 11 5 0 795 9 1 312 269 29 34 4 10 0 86 16 89 3 57 65 4 8 o 15 58 00 02 36 10 7 0 829 8 9 303 269 29 33 3 99 0 88 16 87 3 67 65 4 6 O 15 50 00 02 42 10 9 0 736 8 0 269 234 30 34 3 54 0 86 16 96 3 53 64 4 2 O 15 57 00 02 47 10 7 0 821 8 8 299 260 29 34 3 94 0 86 16 89 3 59 65 4 6 O 15 45 00 02 52 11 3 0 875 9 9 335 297 29 33 4 41 0 88 16 91 3 65 65 5 1 0 1s n oen on 223 ana an 2 HEYSEM te ye iE Yan Fuer ay The software is provided with powerful functions custom graphs to create exactly
49. 1 Rest Start 00 00 00 End 00 01 08 Speed 0 Load2 0 Load3 0 Min 14 6 0 586 8 6 212 157 28 35 3 16 0 73 16 51 2 49 88 2 2 15 09 4 12 Max 21 0 0 971 20 3 619 489 39 52 9 24 0 82 17 68 3 58 107 6 6 15 90 4 76 Average 16 8 0 747 12 7 349 272 33 43 5 22 0 77 17 23 2 95 94 3 6 15 60 4 29 Trend 19 6 0 853 16 9 542 429 28 36 8 09 0 79 16 65 3 47 106 5 1 15 21 4 65 Phase n 2 Exercise Start 00 01 10 End 00 07 05 Speed 4 Load2 0 Load3 Min 17 5 0 811 16 7 540 420 23 28 8 06 0 72 15 75 3 54 110 4 7 14 34 4 37 Max 51 5 2 883 138 1 3367 3978 45 36 50 25 1 32 17 99 4 37 196 18 7 17 20 5 36 Average 34 4 1 904 70 1 2074 2148 30 31 30 96 0 97 16 77 3 90 160 12 4 15 76 4 88 Trend 46 3 2 659 123 2 3158 3704 37 32 47 13 1 17 17 50 3 80 187 16 8 16 80 4 71 Phase n 3 Recovery Start 00 07 07 End 00 10 43 Speed 0 Load2 0 Load3 0 Min 25 2 1 170 34 0 477 834 33 28 7 13 1 16 16 95 3 02 130 3 3 16 09 3 82 Max 43 2 2 799 118 0 3143 3647 si 46 92 1 87 18 87 4 43 190 16 5 18 21 5 42 Average 34 6 1 880 66 3 1368 1910 51 35 20 42 1 45 18 11 3 57 156 8 3 17 41 4 45 Trend 30 6 1 268 38 8 770 968 at 37 11 50 1 25 18 10 3 29 132 5 8 17 50 4 12 ET It is possible to print graphs and data by means of two functions Print report and Print current window The last one is active only if the active window is a graph or a data report Chapter 7 Exercise Testing 87 View the report 88 K4 b User Manual Print the current window 1 Be sure that th
50. 3 Measurement and analysis of gas exchange during exercise using a programmable calculator Sue Hansen Blais Wasserman JAP 49 3 1980 456 461 Principles of exercise testing and interpretation 2 edition Wasserman et Al 1994 Clinical Exercise Testing 3 edition Jones 1988 ERS task force on standardization of clinical exercise testing Clinical exercise testing with reference to lung disease indications standardization and interpretation strategies J Roca B Whipp S Anderson R Casaburi J E Cotes P Palange ERJ 1997 10 2662 2689 Indirect calorimetry Energy Expenditure and Fuel Selection in Biological Systems The Theory and Practice of Calculations Based on Indirect Calorimetry and Tracer Methods M Elia G Livesey World Rev Nutr Diet Basel Karger 1992 vol 70 pp 68 131 Nutritional Assessment in Critical Care A Training Handbook Donald C Zavala Spirometry ATS 94 Standardization of Spirometry 1994 Update American J Respiratory Critical Care Medicine Vol 152 1107 1136 1995 ERS 793 Standardised Lung Function Testing Official Statement of the European Respiratory Society The European Respiratory Journal Volume 6 Supplement 16 March Lung function J E Cotes Blackwell scientific publications Guidelines for Clinical Exercises Testing Laboratories I L Pina G J Balady P Hanson A J Labovitz D W Madonna J Myers Amer
51. 39 06 9314580 E mail customersupport cosmed it For USA customers only please contact COSMED USA Inc 2211 North Elston Suite 305 Chicago IL 60614 USA Phone 1 773 645 8113 Fax 1 773 645 8116 email usa sales cosmed it To ensure that you receive efficient technical assistance please specify as precisely as possible the nature of the problem as it is specified on the assistance information form We advise you to save the original packaging You may need it in case to ship the unit to a technical assistance centre Privacy Information Dear Customer we inform you that your personal data are gathered and will be used by Cosmed Srl in conformity with the requirements of the Italian privacy law Decreto Legislativo 196 2003 We believe it is important for you to know how we treat your personal data Personal data treatment and purposes We request and process your personal data a to place an order register a product request a service answer a survey enter a contest correspond with us all of the above in the following service and if necessary to supply the Competent Authorities with the required information in order to define your commercial profile in order to use your commercial profile for own marketing and advertising purposes for accounting purposes including e mailing of commercial invoices for providing your information to selected business partners also abroad in order to su
52. 7 1046 2993 0 2 2985 0 50 1048 2995 0 1 2972 0 93 1052 3010 0 33 2993 0 23 1052 2993 0 23 3019 0 63 1051 2984 0 53 2992 0 27 1051 2990 0 33 2994 0 20 1051 3004 0 13 3009 0 30 1050 3008 0 27 2988 0 40 1051 2996 0 13 2974 0 87 1051 3006 0 20 Move the calibration syringe re Gain 1027 1028 1026 1027 1027 1028 1027 1027 1027 1027 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 the new calibration factors Press OK to store the new value Chapter 4 Calibration 55 Turbine Calibration Results Ez Date 26 01 97 Syringe ml 3000 Type mm Gain Exp 1038 Cancel Gain Ins 1054 Default Help ddi Turbine calibration using the Portable Unit 1 Screw up the adapter for the calibration syringe to the optoelectronic reader 2 Connect the optoelectronic reader to the calibration syringe Before starting the calibration be sure to have inserted the right reference value for the syringe To check it select Volume Syringe from the Set predicted value menu Syringe volume vol 3000 ml 3 Then choose Calibration from the main menu and press Enter Scroll the menu choose Turbine Calibration and press Enter 5 Start moving the syringe till the message Operate syringe will disappear on the display The display will show expired E and i
53. 7 16 3 VE VO2 57 ee VE VCO2 35 P Sist mmHe P Diast mmHg _ _ REE kcal day en a 1738 7 VO2RLT ml min 1274 vo2 Jones ml min ae 3534 3059 115 54 vo2 Kg Jones ml min Kg shr t 46 50 40 25 115 54 Anaerobic Lactate Threshold detection The software allows to detect the Lactate Threshold Anaerobic Threshold according to the Modified V slope method reference The LT can be detected both manually and automatically View the Lactate Threshold Choose Lactate Threshold from 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 choices Lactate Threshold x VC02 nl min Fetozi Fet C02 39914 13 00 13 00 Bi B 3592 4 H 16 20 21 16 20 E an Note Double click in the a a i ala da vaG window to open the 2794 12 604 12 60 corresponding dialog box 2395 10 80 10 80 19964 9 00 3 00 1596 4 7 2074 7 20 D 11974 5 404 4 5 40 7984 3 604 i 3 60 399 4 1 804 1 80 0H gt 25 802 tu l
54. 8 Set the reference values using the Portable Unit 49 Room air calibratiOn eke keke kek k 49 Room air calibration using the PC software 49 Room air calibration using the Portable Unit 49 Reference gas calibration u keke 50 The calibration Qinit 5i i5544 45 40 nieri 50 Reference gas calibration using the PC software 50 Reference gas calibration using the Portable Unit 51 Gas delay calibration ke keke en 52 Delay calibration using the PC software 52 Delay calibration using the Portable Unit 53 Print the calibration report kk keke 53 Edit the calibration factors kek ek 53 Turbine calibration ssss0000ss0000000000nnnnnnnnnnnnnsssnnnnnsssnnsnnssssnnnnnen 54 The calibration Syringe L kk een 54 Turbine calibration for ergospirometry tests 54 Assembling the flowmeter eee 54 Calibrating the turbine eee 55 Turbine calibration for the RMR test 56 Assembling the flowmeter Eeee 56 Calibrate the turbine keke 57 4 K4 b User Manual Checking the system signdlS ssrssereeeoeeooeeooee neee 58 The control panel keke keke 58 Using the control panel eee 58 Operating modes 59 K4 b Operating
55. 81 Enter Load and Phase keke 81 Set the markers nat eee e n e exe enden 81 Automatic DIOtOCO LL Eke keke ek k kk kek 81 Modify the load during the test 81 Set the BPM alarm ys 45 xall Kal nNAN A N ReN MAN aet ah 81 Enter the BPM 2 na kky iy n keki yey nen K n eyek NEK ex se kb k 81 Data mel dge mel c s d cuaek k ae d neta desnk n s d k ne ke 82 Viewing data sisser kesek sey ereni kek nenn sea R yake be N c KANA 82 View data in table form eee 82 Creating graphs 8 iyi de lel l ye kek h k n dele ka bek e nenne 82 View data in graph form eken 82 Customise the grapl S keke 83 6 K4 b User Manual Switch from graph to data and vice versa 83 Viewing predicted valuUesS E keke ekeke 84 View predicted values E eee ek k 84 Anaerobic Lactate Threshold detection 84 View the Lactate Threshold 84 Detect the Lactate Threshold 84 Customise graphs for the LT viewing 84 Fitti O n a een ange doc clas s wei nd ewar y n era d 85 Fit a graph with a linear regression 85 Fit a graph with a Mono exponential regression 85 Calculate the Mean V
56. 9 28 Chapter 8 Resting Metabolic Rate Test 105 Viewing the test Nota The percentage of used Proteins PRO is calculated assuming 12 grams of Ureic Nitrogen in 24 hours You can modify this value selecting View Information gt Modify At the rend of the test it will be opened automatically a window with the test results File Test Events View Options Window 2 l x PESE EIA EA R Ve me hi M Eh DATA GRAPH Hz EDIT ea v H 5 vo Ema B Ea Parameter Rest Pred Pred BMI Statements Time mm ss 09 30 10 00 95 0 Underweight lt 18 5 RMR Kcal day 1981 1 1731 9 114 3 Normal 18 5 24 9 R 0 82 0 85 96 8 Overweight 25 0 29 9 VO2 ml min 286 266 107 7 Obesity class 30 0 34 9 vCO2 ml min 235 226 104 2 Obesity class Il 35 0 39 9 Rf b min 13 7 12 0 114 2 Obesity class Ill gt 40 VE l min 9 0 6 0 150 4 HR bpm 72 FAT 59 5 CHO 40 9 BMI Kg m 2 23 9 Normal Elke Keal day 3500 04 ee ee ee 4424 20 24 PER ER FEED 2a4 2ARI ee le nal nayan dae amp n k a ayaz n d 3000 04 2500 0 J 2000 0 1500 0 1000 04 Are aoe ae toads SEE See Mak He Ke E teens tacts Den kr sax Te LE ABE BA De MEN QOT TT a TE hm ss 00 00 01 00 02 00 03 00 04 00 05 00 06 00 07 00 08 00 09 00 10 00 11 00 12 00 13 00 14 00 15 00 16 00 17 00 18 00 19 00 20 00 At the end o
57. C Turning on off the receiver unit To turn the receiver unit on or off use the switch on the front side of the unit Receiver unit power supply The K4 b Receiver Unit is provided with four 1 5 V AA batteries Before turning the unit on be sure that batteries are charged If the status battery indicator blinks red you must replace the 4 batteries The unit can be also supplied by 6V DC power through the cable provided in the equipment The receiver unit can be supplied by two different sources e by the Battery Charger Unit connect the units by the 6V DC cable e by 4AA 1 5V batteries Calibration Gas Cylinder In order to calibrate the sensors you need to have available calibration cylinder with the following gas concentration Cylinder Recommended Gas mixture Calibration O 16 CO 5 N Balance For the calibration procedure see the Calibration chapter Chapter 3 Installation 39 Connecting the K4 b to the patient K4 b is a portable system with a total weight lower than 1 kg Cosmed has developed a special harness to fix the unit to any subject The harness consists of a belt that can be adjusted to fit different sizes and positions I e if you need to test cyclist or rower athletes we recommend to locate both units K4 b and battery on the back of the subject to increase comfort and to avoid any obstacles during movements For this reasons plates are provided with the harness and they can be easily removed and p
58. COSMED Register the product via software Together with the PC software a registration software is supplied With this software it is possible to fill in an electronic form with the customer information 1 Torun 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 Via dei Piani di Monte Savello 37 P O Box n 3 00040 Pavona di Albano Rome ITALY Voice 39 06 931 5492 Fax 39 06 931 4580 email customersupport cosmed it Internet http www cosmed it Complain feedback and suggestions If you have any complain feedback information or suggestion please inform us at complain cosmed it Chapter 1 Getting started 27 Options Accessories Accessories Options 28 K4 b User Manual Code C02150 01 11 C00600 01 11 C02115 01 10 C02114 01 10 C02113 01 10 A 800 900 004 A 800 900 017 A 800 900 018 A 800 900 019 A 800 900 020 A 800 900 021 Had j kak j zk ak Hak J a le le Tele Io Quantity Description Adapter Spirometry kit x opto reader 2000 3 liters syringe for flows and volume calibration Adult face mask with x Turbine 2000 Mask mouth nose breath ID28 paediatric L Mask mouth nose breath ID28 paediatric S Paediatr
59. COSMED does not assume any liability for end user interpretation of this user manual or for casual or consequential damages in connection with the provision representation or use of this documentation No parts of this manual may be reproduced or transmitted in any form without the expressed written permission of COSMED Srl Each copy of the COSMED Software can only be installed on one computer 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 K4 b User manual XVIII Edition 05 2008 Copyright 1998 COSMED Copyright 2003 COSMED COSMED Srl Italy http www cosmed it Part N C01508 02 91 Table of contents Getting started 13 Importantin tices sccsssossccsssesssessenuneusns unsdusennssunnennsennneansenseunsenn 14 Intended use a nsnss san de K e key n de E Are be kan 14 WaN 4 a a bina ek kay n l R Helen ba b ya s r Pek erek 14 Contraindication i 3 4 i455454s 5 5305s sek y s e ekeoe kes n e kes n s e kn s k k 17 Contraindications for the Spirometer tests 17 Absolute contraindicationS e 17 Relative contraindicationS k eee 17 Contraindications for Bronchial provocation tests 17 Absolute contraindicationS ee 17 Relative
60. Current medications e Activity patterns e Nutritional habits e Reading and signing an informed consent form Sub maximal exercise testing Heart rate varies linearly with VO to the point of maximum exertion thus VOomax may be estimated using the relation between heart rate and VO without subjecting the individual to maximum levels of physical stress During sub maximal exercise testing predetermined workloads are used to elicit a steady state of exertion plateau of heart rate and VO The steady state heart rate at each work level is displayed graphically and extrapolated to the VO at the age predicted maximal heart rate HR 220 age A variety of protocols for different exercise modalities i e treadmill stationary cycle and step increments can be used as long as the VO requirements of each selected workload can be estimated with accuracy The objectives of cardiorespiratory fitness assessments in the apparently healthy population are as follows e Determine the level of cardiorespiratory fitness and establish fitness program goals and objectives e Develop a safe effective exercise prescription for the improvement of cardiorespiratory fitness e Document improvements in cardiorespiratory fitness as a result of exercise training or other interventions e Motivate individuals to initiate an exercise program or comply with an established program e Provide information concerning health status A few assumptions reg
61. Dioxide and the accuracy of the followina test Cylinder 15 05 Cylinder 6 02 296 526 Base line mY Base line mY Gain 1023 Gain 1605 Delay ms 673 Delay ms 592 OK Cancel Default Help Room qir calibration using the Portable Unit 1 Remove the sampling plug from the flowmeter 2 In the main menu choose Calibration menu choose Room Air Calibration and confirm by pressing Enter Do not breath 02 20 7 C02 0 4 3 The procedure is automatically performed until the message Calibration done appears the O and CO values will be visualized on the display Calibration done 02 20 9 CO2 0 0 4 Exit the Calibration menu by pressing Enter or Cancel Chapter 4 Calibration 49 Reference gas calibration The software allows to automatically calibrate zero gain and alignments of the gases vyy sensors Even if the program doesn t force you to carry out the calibration the system Notice Do not use mixtures Should be calibrated before each test To perform the sensor calibration is necessary to with a O2 concentration above have available a cylinder filled of a concentration known of mixed gas It is suggested 24 since it is out of the to use CO 5 00 O 16 concentrations and N for balance oxygen sensor range The calibration unit vvv The gas regulator has an adjustable second stage that must be open every time the Notice Before calibrating be cylinder is
62. HR SISINNI E test n 4 TAl Eile Test Events View Options Window mare _ a A vuo2_ PROIA a SAIR 3 aro ENT F SH BS DADs Dae TELE TEST DATA GRAPH AT NORMS ETW vHR Feier V02 Eg nl min Eg j j i j v O2 Kg extimated 40 56 I i 1 H 1 Pred 34 21 45 004 i 4 ia i J amp 6Pred 118 5 SISINNI EMANUELA 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 116 K4 b User Manual An example of protocol is reported here The YMCA cycle ergometry protocol is defined as follows 1 step workload 150 kgm min 2 step if the HR at the end of the 1 step is lt 80 80 89 90 100 gt 100 set the workload at kgm min 750 600 450 300 3 step if the HR at the end of the 2 step is lt 80 80 89 90 100 gt 100 set the workload at kgm min 900 750 600 450 4 step if the HR at the end of the 3 step is lt 80 80 89 90 100 gt 100 set the workload at kgm min 1050 900 750 600 The mixing chamber The mixing chamber Overview The mixing chamber is a 7 litres plexiglas box for exercise or resting VE lt 40 l min tests For resting tests only a part about 2 3 litres of the mixing chamber is used The mixing chamber is shown in the following picture Y a m 2 ji j 6 3 4 o 7 5
63. I Chapter 8 Resting Metabolic Rate Test 107 Performing a test using the canopy option The principle of a ventilated bubblehood system is that a stream of air is forced to pass across the face of a subject and mixes with the air which is collected by a transparent hood placed over the subject s head A measurement system knowing the flow rate calulates the oxygen consumption and the CO production and starting from these values the energy expenditure Calibrations Before the test it is necessary to perform an ergo calibration see Calibration chapter and it is advisable to perform also a turbine calibration see Recommendations in this chapter How to prepare the canopy and the patient Replacement of the power plug If the power plug does not fit into the mains socket replace it with the one in the packaging In order to replace the plug 1 Extract the plug from the battery charger 2 Insert the proper plug in the battery charger ry id Connecting the Canopy 1 Connect the Canopy unit to the mains by means of the medical grade AC DC adapter provided 2 Fix the vail to the bubblehood through the velcro strips 3 Insert the bubblehood adapter into the bubblehood from the outside and fix it screwing the ring from the inside being careful to insert it in the proper hole as shown in the following picture rh Connect the bubblehood to the wrinkled tube interposing a bacterial filter 5 Conn
64. N N m me e N N e A ee ee d DIA RRL n a SO KA KRA RAW RL Re AWN w N m me e N N A KAW KA ee AW mA Description see note by side K4 b Portable Unit K4 b Portable Unit K4 b Portable Unit K4 b Portable Unit K4 b Receiver Unit K4 b Receiver Unit K4 b Battery Charger Unit Antenna Antenna cable Turbine 28mm Kit optoelectronic reader K4 b Head cap for the adult masks Permapure L73cm Mask mouth nose breath adult S Mask mouth nose breath adult M Mask mouth nose breath adult L HR elastic belt HR polar transmitter Anti moisture filter RH TA probe Power cord Schuko 2m RS232 cable K4 b Cigar light adapter Battery size AA 1 5V Battery pack TX K4 b Battery pack TX K4 b Cable power supply BNCxRF Cable power supply RX unit Harness K4 b adult Velcro strips set 8 pieces Kit gas calibration Carrying case Holder Portable Unit Time lag fuses 5x20 250V T500mA Time lag fuses 5x20 250V T630mA Fuses 6 3x32 250V F5A PC software Conformity declaration Registration card K4 b User Manual Warranty registration Before using the system please take a moment to fill in the registration form and the warranty and return them to COSMED by doing this you are eligible to the customers assistance service For further information please refer to the enclosed registration and warranty form If the form is not enclosed in the packaging please contact directly
65. O2 in the Transition from prior Exercise Evidence for O2 Transport Limitation of VO2 Kinetics A Review R L Hughson and M A Morrissey Int J Sports Med 4 1983 31 39 ISO 8996 Ergonomics Determination of metabolic heat production 1990 In the following picture it is shown how the O debit and deficit values are computed Y A B exp t to Tau 02 Kinetics YA B exp t t1 Tau VOZ rest A B VOZ rest A VO2 work B VO2 work B 25 to start work t1 start work t1 stop work t2 end test O2def VO2 work Tau O2debt VO2 work tau 2 AT 02 deficit in VO2 l min vo2 work VO2 work 02 debt Vo2 rest Vorerst vo v 0 50 to 100 150 1 200 250 300 time ec ATS 94 recommendations Reference Standardization of Spirometry 1994 Update American J Respiratory Critical Care Medicine Vol 152 1107 1136 1995 ATS recommendations Volume range 81 BTPS Flow range 14 l sec Volume accuracy 3 or lt 50ml Flow accuracy 5 or lt 200mlV sec Flowmeter resistance lt 1 5 cmH2O da 0 a 14 l sec Reproducibility the 2 largest of 3 acceptable FEV1 and FVC values should be within 5 or 150 ml The end of test no change in volume for 1 second 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 F
66. Quantitative Analysis of the Alveolar Plateau in the Diagnosis of Early Airway Obstruction ARRD 108 1081 1973 Mansell A Bryan C Levison H Airway Closure in Children JAP 33 711 714 1972 Buist SA Ross BB Predicted Values for Closing Volumes Using a Modified Single Breath Test ARRD 107 744 751 1973 Rint Lombardi E Sly PD Concutelli G et al Reference values of interrupter respiratory resistance in healthy preschool white children Thorax 2001 56 691 695 Mip Mep Leo F Black Robert E Hyatt Maximal Respiratory Pressures Normal Values and Relationship to Age and Sex American Review of Respiratory Disease Volume 99 1969 Vincken W Ghezzo H amp Cosio MG 1987 Maximal static respiratory pressures in adults normal values and their relationship to determinants of respiratory function Bull Eur Physiopathol Resp 23 435 439 Automatic diagnosis algorithm Reference Lung Function Testing selection of reference values and interpretative strategies A R R D 144 1991 1202 1218 LLN Pred 0 674 SD ATS 50 percentile LLN Pred 1 647 SD ERS 95 percentile LLN Pred 0 8 80 Pred Message interpretation Criterion Normal Spirometry FVC and FEV1 FVC gt LLN Obstructive abnormality it may be physiological Pred FEV1 gt 100 Obstructive abnormality mild Pred FEV1 lt 100 and gt 70 Obstructive abnormality moderate Pred FEV1 lt 70 and gt 60 Obstructive abnormality moderately severe
67. To enhance the value of a diagnostic test it s very important patient collaboration In most cases a well informed patient will make a better effort in relation to his conditions and will allow a reliable interpretation of the test For this reason every ergometric test must be preceded from a precise training of the patient Before testing The physician applying the exam must be provided with a written request including a brief description of the diagnosis confirmed or suspected the request s reason and the patient therapy carried out showing the dose and time of the drug assumption To standardise the response to the test and reduce the patient s anxiety it s suggested to provide him either written before the exam or oral at the same time of the test information At the scheduling time detailed instructions should be delivered to the patient consisting in smoke and food abstinence three hours before an ergometric test or eight hours before a scintigraphic test Test are usually executed supporting the therapeutic outline in progress but sometimes it could be necessary to stop some drugs such as b block or calcium antagonist which could impair the effort response reducing the diagnostic accuracy of the exam The patient must wear comfortable suit and gymnastic shoes and two hours before test stop any kind of drugs eat light and avoid coffee and smoke It s very important acquire information on the patient s clinical pas
68. VC 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 then 5 FVC or 150ml The graphic resolution of the printed report must be as in the following Volume 10 mm l Flow 5 mm 1 sec Time 20 mm sec F V ratio 2 1 The total number of error FVC e FEV1 gt 3 5 FEF25 75 gt 5 5 during the measurement of the 24 standard waveforms must be lower than 4 Chapter 13 Appendix 157 Predicted values 158 K4 b User Manual ERS93 Standardized Lung Function Testing Official Statement of the European Respiratory Society The European Respiratory Journal Volume 6 Supplement 16 March 1993 Compilation of reference values for lung function measurements in children Ph H Quanjer J Stocks G Polgar M Wise J Karlberg G Borsboom ERJ 1989 2 Supp 4 184s 261s KNUDSON 83 Changes in the Normal Maximal Expiratory Flow Volume Curve with Growth and Anging J Knudson D Lebowitz J Holdberg B Burrows ARRD 1983 127 725 734 ITS Intermountain Thoracic Society Clinical Pulmonary Function Testing second edition 1984 pp 101 144 LAM A survey of ventilatory capacity in Chinese subjects in Hong Kong Lam Kwok Kwong Pang Shing et Al Annals of Human Biology 1982 vol 9 No 5 459 472 Multic ntrico de Barcelona Spirometric reference values from a Mediterranean po
69. aE 74 Import export a Tests card L eke keke 74 Diagnosis Database u eke k k k k k 74 Spirometry program SETHINGS cccccccssccssccesccesccesccesccsscesscoescoes 75 r 0o R Y DE aa r 75 Serial Port A xy G sin n H key kenne 15 Units of measurementS Eu eke ek 75 Using extra f eldS i Kwin nanna xek al el NNN 75 Customise the fieldS eee 75 Exercise testing 77 Recommendations for the exercise testing 78 The evaluation of the cardiorespiratory function 78 Precautions nnen eip a a fear ln Nine 78 Laboratory qe kela eee ee EE A 78 Ending the test L eee kek keke ke k 78 Preparing the patient L eke ek k 78 Before testin Oi ccs cescecsstusseceissusteces od eeceits oudsaguteaea ctateele ie 78 Patient assent crei is e a neste satel h 79 Ending heiteste zaa a nir Sota n Ve oye 79 Real Time 16S 4 4 5 54 23 5545 a554c505 ak Ca kules ea s ve kuve kan e den vek seen 80 Start a tesben a nen His 80 Abort the test without saving data 80 End the test saving data ek 80 View data in real time keke keke 80 View graphs in real time nnennenneenennnen 80 Parameters tO view ar Ki seye w k ke x r An 80 Manual protocol si k P k EE kk in bh ne k aai Enee
70. alue eee 86 Oxygen Kinet ssi ses sie Rt usa an 86 Run the O2 Kinetic function eee 86 Information about the Test eee eken 87 View the Information reke eke 87 Modify the information keke 87 elin na E AM rrr MM 87 View the summary E neee keneke k ek ek 87 Print the dal yin ul ye bee ses 87 Print the current window Eu ek kkk eke 88 Print therepott asus ln y dekar ERE ed Ereb ek Rayeka de 88 View the report L Eek eke k ke keke k keke 88 Data Edifir g isi i sis se i45 300534 0s 0 00354004408 04ob 49 s 0 990340650059 0s453e0 e40 040 en 89 Editing values and input numerical values 89 Datta filtering 2 2 2 2 ea nn 89 Using the User fields keke 90 Deletingistepsu ungen ner b n Kek n E w k kaye gang 90 Advanced Editing u ekey ek 90 Restore the original test ek 91 Overwrite the original test 91 Customise the desktop keke keke k k 91 Customise the display colours e 91 Smart editii n dayka k k kabe E Ke ER Pe aye k w n e ER v vik ANA 91 Apply the graphical noise suppression 91 Apply the threshold noise suppression 91 Customise the parameters 0 ccccecsseeseeseeeseeeneeessecnseeneenseens 92 Create a new parameter ce eecceesseceeeeeeteceeneeeeneeee
71. and parameters in different file formats e xpo Cosmed proprietary file format txt ASCII xls Microsoft Excel wkl Lotus 123 Export a test 1 Choose Export Tests from the Test menu 2 Select the test to export from the list box and press OK to confirm 3 Select the file output format from the list box click on xpo txt xls or wkl If you selected ASCII format by clicking on Text button you can then select the Thousands 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 K4 b equipment 4 Select the folder type the file name and press OK to confirm Export test n 1 2 x File name Folders test 25 xpo c cosmed k4b2_en Em cosmed k4b2_en I drivers test Save file as type Drives Cosmed format xpo c hard disk c available only if the user PC DDE with Excel has Microsoft Excel installed 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 Test menu The program will show a status bar indicating the data transmission to Excel At the end of the process a new sheet with all test data will be opened ready to be edited with the powerful functions of Microsoft Excel Chapter 7 Exercise Testing 93 Creating Test Protocols The software allows
72. arding testing are necessary to ensure the highest degree of accuracy when using sub maximal exercise testing to estimate VOomax e Selected workloads are reproducible A steady state heart rate is obtained during each stage of the test Usually workload durations of 3 minutes or more are used to ensure steady state e The maximal heart rate for a given age is uniform HR 220 age e Heart rate and VO have a linear relation over a wide range of values thus the slope of HR VO regression can be extrapolated to an assumed maximum heart rate e Mechanical efficiency i e VO 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 not be used as a replacement for clinical exercise tests or other clinical treatment or management modalities Health care professionals should avoid detailed interpretation beyond the scope of the information obtained Considerations with sub maximal exercise testing Considerations for selection of protocol and equipment include any physical or clinical limitations that may preclude certain types of exercise i e age weight arthritis orthopaedic complications individual comfort level of fitness type of exercise training that will be performed and individual preference For example some individuals may perform better on a non weight b
73. at you can get from this manoeuvres are the flow reserve flow distance from the peak flow of the F V loop during exercise to the corresponding flow on the superimposed F V loop at rest and the volume reserve volume distance from the maximum volume of the F V loop during exercise to the corresponding volume on the superimposed F V loop at rest The manoeuvre consists in the following phases e Acquiring some Flow Volume loops during the exercise 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 e 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 form Test Event 3 As soon as 2 or 3 complete loops have been acquired ask the patient to inspire completely up to TLC level and press F3 to stop the acquisition The O2 CO2 event is useful to check the real time readings of the O2 and CO2 signals during the test O2 CO2 vs Time during the test 1 Start with normal Exercise test and begin the memorisation of breath values F2 2 During a steady state select O2 CO2 vs Time from Test Event 3 As soon as 5 or 6 complete breaths have been acquired press F3 to stop the acquisition p p Event 02 CO2 Graph ioj x 02 G coz
74. ate of test 12 07 01 PB mmHg 740 Sex M Time of test 09 49 Humidity 50 Age 25 Duration 00 02 43 Height cm 170 N of steps 71 Weight Kg 70 0 li _ Extimated download time 00 00 03 Preview First Previous Next Last p Link to Last name GPS Find ID code i TEST First name Progr 5 ID code default 14 To download a test you must link it to an existing patient file Choose Find and then List to select an existing patient If the patient is new than select Find and then New fill in the fields and press OK to confirm Select the test to link by using First Previous Next and Last buttons and press Download to confirm your choice and to store the test on the Hard Disk You can use the Preview button to see some data and graph of the test in order to find out the proper one Serial Mode Note USA and Japan versions have the items 3 and 5 slightly different because of the antenna place Operating sequence When the K4 b is used in the serial mode the system works exactly as any other conventional laboratory station In this mode the software controls completely the K4 b portable unit so that any command such as calibration can be run by the software You can also drive an ergometer if a second serial port is available in the PC Power cable Receiver unit RS232 cable 10 Personal computer 1 Mask flowmeter 2 Heart rate belt 3 Rechargea
75. av ek ewe essen 67 Operating sequence namens Pa i daka dbn 67 Warming up the System ee ek k 67 Connect the Portable unit to the PC 67 Calibrate the SyStem uEE keke 67 Enter patient data ekey k 67 Start the test SAND N r a i a tee 68 Stop the t Se yaya ley h n nl keri b e eb e dek 68 Database Management 69 Exercise testing patient s database esssuesssnensnnnensnnensnsuensnncnse 70 Enter a leW Datleh e li Wk la b nene k r a 70 Finda Dall llk 3 y na e ab Ghia inne 70 Edit patient data ni 14 4 y 30431 044554 3 12 nlv oke a 0000 046956 Aaa 70 Delete a patient 4 Asin ki ks lk men re anl ek dk kaka iess 70 Uploading tests from the Portable Uni 71 Archive maintenance ssssssssssssnnnnnssssnnnsnsnnnnnsssnnnnnssssnnsnnsssnnsnnsssnnnee 72 Reorganise the archiVve u keke keke 72 Delete the rchivesn nu el lk Har 2ER T2 Delete atest ea areas ec wS ae dies T2 Index 5 Backup nase ke y deade dea a N keteka d 72 Restos a Pan N RE aka VE be e HAA bene d b Xak 72 Spirometry patient s database ccssccccsscccsssccsssccssssccssscssescoeees 73 Patient Cardeso n E aiden 73 Visit Card sis xak lan ikak a el Wa e N dU krd keke d AR 3n 73 Test Car si yiy rent ken e aceite Wek
76. ble battery 4 Harness 5 K4b Unit 6 HR probe 7 8 9 Warming up the system Warm up the K4 b for 45 minutes before testing or calibrating Connect the Portable unit to the PC 1 Connect K4 b to the PC by the serial cable 2 Check that the Serial Port is properly selected by choosing RS 232 from the Option menu 3 Check the Ergometer connected to PC option box if you intend to use an ergometer for testing Calibrate the system 1 Run the K4 b software and choose Calibration from the Test menu 2 In the Calibration software select Analyzers gt Room Air from the Calibration menu Enter patient data 1 Inthe K4 b software and choose Patient from the File menu Patients in archive x Search for Find Last name New CID code Progressive Eind List Cancel Patient 7 Progr 5 Last name GAS ECG First name INCREMENTAL Sex M Delete Modify OK Ti 2 Select a patient from the list or press New to enter a new name and press OK to confirm Chapter 5 Operating modes 67 68 K4 b User Manual Start the test 1 Open patient data dialogue box select or type a new name and press OK to confirm The name of the selected patient will appear in the status bar of the software 2 Choose Execute test from the Test menu Execute Test x a r Mode Height cm 180 0 in Weight Kg 180 0 ECG fC Gas ECG C Rest EGG FF Telemetry l Ergometer
77. ble to define the created filename format selecting Options Printout header and then Name format Printed file name Ea a b date of birth Zi ID 2d date of test Zl last name f first name zn test h time of test Zs sex Cancel 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 customised a report 1 Select the customised report from File menu 3 Set the sheet format and press OK Chapter 7 Exercise Testing 97 Events management during exercise testing Flow Volume loops amp O2 CO2 vs Time 98 K4 b User Manual By using K4 b in serial mode beside standard measurements the software allows also to save some extra events They are so called events since they are not continuously stored during the test but they can be saved upon user selection This test is useful during exercise to detect abnormalities in the mechanics of ventilation in patients with pulmonary ventilatory limitations to exercise The test consists in acquiring some flow volume loops during exercise at different workloads and overlapping them on the rest maximal flow volume loop of a Forced Vital Capacity test The majors information th
78. c Rate represents the calories that the vital organs need to properly operate at rest heart brain lungs liver kidneys etc RMR represents between 60 and 75 of the human s total metabolism Importance to measure RMR A knowledge of the RMR is very helpful in order to understand the nutritional needs and to properly manage it Measure of the rest metabolic rate with indirect calorimetry Energy expenditure can be measured directly by putting a person in a calorimeter and measuring the amount of heat produced by the body mass This is expensive and very impractical in the clinical setting Energy expenditure can be measured indirectly with a metabolic cart by analysis of respired gases usually expired to derive volume of air passing through the lungs the amount of oxygen extracted from it i e oxygen uptake VO and the amount of carbon dioxide as a by product of metabolism expelled to atmosphere CO output VCO 2 With 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 a RMR test For best results when having a REE done there are certain conditio
79. chive 1 Select Bronchoprov protocols database from the File menu 2 Type the Protocol name the Bronchoprovocator name and the unit of measurement in the proper input fields 3 If the bronchoprovocator has a cumulative effect select the cumulative check button 4 Enter the quantities for each step and press the button E Viewing results All the visualisation functions refer to the test carried out by the Current Patient whose name is indicated on the left side of the status bar To view tests results 1 Select the Patients from the File menu 2 Select the patient corresponding to the test you want to view 3 Select in the list box of the tests up to 5 tests of the kind FVC VC IVC or MVV and press OK To switch between graph and or data use the following buttons on the toolbar view Flow Volume graph F5 view Volume Time graph F6 view data of the test F7 SEEN 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 e Select Visits list from the File menu e 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 current patient has been selected you can quickly view his tests selecting Test current patient from the View menu Delete a test 1 Select Patients from the File menu or p
80. coees 150 Service Warranty cccccsccssccssccssccesccssccesccssccssccsscesscoescsescoesces 151 Warranty and limitation of liability 151 Return goods policy for warranty or non warranty repair 151 Repair Service Policy s saqa ke xilt kiya Kake nen naar 152 Privacy Information esssseosssnensnensnnunsnsnennnnnnsssnenssnensnsnenssscnse 153 Personal data treatment and purposes 153 How your personal data are treated nnenee 153 The consent is optional but K e eeeeee 153 Holder of the treatment E keke 153 Customerrightsi en s senken 153 Waste of electrical and electronic equipmen 154 Converting factors configuration cccsssccsssccssssccssscssscossscoeees 155 Calculations references ssssscssssnnnnnsssnnnnnnssnnnnnnsssnnnnnsssnnnnnssssnnnnnes 156 VOJ aNd NEO ernannten 156 Anaerobic threshold modified V Slope 3 156 O5 kinetics 24 Rss DD r gg 156 ATS 94 recommendations ssssssssssnsnnnssssnnnnnsssnnnnnsssnnnnnssssnnnnnennne 157 ATS recommendationS u ek keke 157 Predicted values ssssss0sssssnssnnsssnnnnnsssnnsnnnssnnnnnnssnnnsnnsssnnssnssssnnne 158 Automatic diagnosis algorithm E 159 Quality Control Messages nennen 159 References scosstecrcssssserscinssessussnseneuihseesssnsnsensensnagseesenerseehese
81. command no one Ra Final command no one Ra Software configuration Data viewing Steady State The software can be customised as you wish Most of the feature are easily editable to be tailored according to different purposes The software allows to calculate a huge number of parameters it is advisable in order to simplify the analysis of the results view in the data window the only desired parameters Select the parameters to view 1 Choose Parameters to view Test visualisation from the Options menu 2 Select the parameters you require to view 3 Press OK to confirm the selected configuration Select the parameters to view during the test 1 Choose Parameters to view Test execution from the Options menu 2 Select the parameters you require to view 3 Press OK to confirm the selected configuration 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 The program has an algorithm to tag sets of steps as Steady State The algorithm considers belonging to the Steady State the only consecutive steps that meet the following conditions e The value of VO2 VE and R do not vary from their mean values more than Thresh
82. ctate Threshold V Slope u keke 32 O2 Gi a aS Sn RD DY DK IRATnr in 33 Spirometry Tests option u eee keke 33 FVC Forced Vital Capacity 33 VC IVC Slow Vital Capacity and Ventilatory pattern 33 MVV Maximum Voluntary Ventilation 34 Bronchoprovocation Response E eee 34 Installation 35 Installation SEQUENCE cccssccssssccssccssssccssscccsssccsscoessccsesscosescosees 36 Battery Charger Unit nrerin e n a r a 36 Check voltage E eke keke keke 36 Turnithe Unit 00 4 2 22541541 1922 head alee eee ee 36 Charge the batteries L eee 36 Battery low einem 37 Portable Unit u ssehsliinslen Ameise 37 WarhUp 2 iur rrr 38 Warming up the unit by main power 38 Turning on off the portable unit 38 Connect the rechargeable battery 38 Receiver Unit ser rare nahene 39 Turning on off the receiver unit 39 Receiver unit power supply u eee 39 Calibration Gas Cylinder eee kek 39 Connecting the K4 b to the patient sssssssssssssssssssssssssssssssees 40 Assemble the mask and the flowmeter U UUU UUUUUUUEjUU 40 Using the Ultimate Seal LL eke 40 Apply the seal to the mask ueer 41 To remove Seal on mask eee 41 Assembling the flowmeter for spirometry tests
83. cturer s declaration electromagnetic immunity The K4 b is intended for use in the electromagnetic environment specified below The customer or the user of the K4 b should assure that it is used in such an environment Immunity test Test level Compliance Electromagnetic environment level guidance Portable and mobile RF communications equipment should be used no closer to any part of the K4 b including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 17VP Conducted RF 3 Veff 3V d 1 17 4 P 80 MHz to 800 MHz IEC 61000 4 6 150 kHz to 80 MHz d 2 33 4 P 800 MHz to 2 5 GHz where P is the maximum output power 3 V rating of the transmitter in watts W Radiated RF 3 V m according to the transmitter manufacturer IEC 61000 4 3 Sen to and d is the recommended separation Z distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Q Notes 1 At 80 MHz the higher frequency range applies 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from
84. e a50 0e7 26 Checking the packing contents 26 Warranty registration cccccsscssssssscssscssscssccssscssscssscssccssscsscesees 27 Register the product via software 27 How to contact COSMED csenneennnenensensenenennn 27 Complain feedback and suggestions 27 Options AccessorieS esseesseesseessuessnennuennuennuensuenssenssenssennsenssenssenssense 28 ACCEssorlesi naiinenkinisinenensenatalnbin ieh 28 Optionsa Rassen ai Rn a DD 28 Telemetry data transmission 28 Spirometry Kitose ieac a a nennen 28 2 K4 b User Manual PC configuration required sssserrrereoe reve ce oe eeoee eee 29 Technical features hhhheenenHe ey ee ee oeee eee eee ee ee eeee eee neee 30 Portable Unis Ay yed Sean a Ebay k KIRE WA erb lasses 30 Receiver Unit 5 32 5 HERR Goede 30 Battery charger Unit keke k 30 Flowmeter eei near 30 Oxygen Sensor Od 5400 y02 41 5 25451545 81 15x244 7abi an e 30 Carbon Dioxide Sensor C 2 xx xxxxxke keke 30 Humidity absorber u eke keke 30 Power Supply inet 30 Environmental SenSorS E eke kek 30 Measurements 31 Pulmonary function tests and measured parameters 32 Breath by Breath exercise testing e 32 Indirect Calorimetry kd 35081304 kser Ae bade xke PE eyek anian 32 La
85. e VD 50 ml for the small mask 60 ml for the medium mask 70 ml for the large mask Resting metabolic rate test using the canopy option 1 Verify before and during the test that the FeCO falls within the range 0 7 1 3 and adjust the flow rate of the pump as necessary If the FeCO is too low you should decrease the flow rate and if the FeCO is too high you should increase the flow rate A low FeCO may result in unreliable measurements while a high FeCO could be dangerous for the patient 2 Do not place Canopy hood over a patient s head before the tube is properly connected and a continuous flow is applied from Canopy Blower Chapter 8 Resting Metabolic Rate Test 103 Performing a test using the face mask Calibrations Before the test it is necessary to perform an ergo calibration see Calibration chapter and it is advisable to perform also a turbine calibration see Recommendations in this chapter How to prepare a patient The patient interfaces with the equipment by means of a face mask as depicted in the following image The mask has to be tight to the face in order to avoid any air leakage r e a Make sure that the subject health status is acceptable according to what stated in the guidelines Make the subject sit or lay on a comfortable chair or bed Fix the mask to the subject as illustrated in the above picture pull the elastic strings Point A and B accurately in order to eliminate po
86. e le Le Workspace RMR Cancel Other data Dame _ Cent Enter the patient s data and select the Canopy mode Confirm and start the test by pressing OK In the first part of the test the flow rate of the pump has to be adjusted by means of the Flow adjustment handle on the front panel of the Canopy unit in order to measure an FeCO between 0 7 and 1 3 FeCO values can be read on the right side of the PC monitor When the FeCO remains within the acceptability range press F2 to start the data acquisition Verify also during the test that the measured FeCO is within the 0 7 1 3 range Otherwise adjust it by means of the Flow adjustment handle Chapter 8 Resting Metabolic Rate Test 109 Viewing the test Note The percentage of used Proteins PRO is calculated assuming 12 grams of Ureic Nitrogen in 24 hours You can modify this value selecting View Information gt Modify Warning If the green led turns off during the test the red led flashes and the alarm beeps abort the test because the pump does not work or the mains does not power the system In the last case the pump works only because of the backup battery The test is fully automatic the software will stop it and save the data at the end At the rend of the test it will be opened automatically a window with the test results At the end of the test or if it is selected View RMR the main results are shown e The ave
87. e button If a set is deleted also the associated formulae are deleted It is possible to generate a new set of predicteds with the same attributes and the same formulae of the selected one To do this click on the Copy button and specify 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 K4 b allows to calculate the predicted values according to the following configurable sets Adult Paediatric ERS 93 Zapletal Knudson83 Knudson83 ITS white ITS white ITS black ITS black LAM LAM MC Barcellona MC Barcellona Nhanes III Nhanes III Select the desired choice in the group Predicted Formula definition Predicteds Ea Predicteds set Formula definition Q Predicteds set YET kA Description Use the predicteds formulae 7 or the customized formulae Male E Female Formula Standard Deviation Young B Adult Lopy Paste Parameter Save Delete Cancel Apply Help This form allows the user to manage the formulae associated to a set of predicteds Select the set of predicteds from the list Predicteds set To insert a new parameter click on the New button The parameter formulae can be Page set up e ca
88. e control panel of the Portable Unit is mainly composed by a keyboard and 4 plugs for power supply turbine antenna heart frequency and sampling tube connections The following illustrations show in detail the control panel KCOSMED K A T e 60 Marker key Display Cancel key Enter key Scroll up down key On Off switch jwaww Connections Temperature amp HR probe 6V Power Cable Turbine Note USA and Japan versions have the antenna not detachable from the portable unit Chapter 3 Installation 37 www Important In order to ensure accurate gas measurements you must wait for a warming up time before operating the K4 b2 During this period the PU must be turned on for at least 45 minutes www Warning Supply K4 b with Charger Unit for warming up only Short antenna Warm up The K4 b uses O and CO heated sensors We strongly recommend at least 45 minutes warm up time at an ambient temperature of 20 C More time is necessary if the environmental temperature is lower Calibration or testing before warm up time is completed can cause wrong results Warming up the unit by main power 1 Connect the Charger Unit to the main power by the AC power cable 2 Connect the power supply cable both in the Charger Unit and K4 b as shown below and turn both the units on Power supply cable Turning on off the portable unit To turn the
89. e current active window is the graph or the report you desire to print 2 Select Print current window from File menu 3 Press OK to print or 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 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 confirm Visualizzazione Report Elenco dei test in archivio Hoas Elenco 1D Data Durata C Paziente attuale 000001 20 02 97 00 14 13 000002 13 03 97 00 15 00 BOND J 000003 1104 97 00 10 43 TREADMIL T Tutti i test 000004 14704797 00 05 16 CARDIAC OUTPUT C 000005 16 04 97 00 07 14 F LOOPS F Report 000006 26 01 00 00 14 45 GAS ECG G RE Const4plot ST t ends C ERS 98 OK Annulla VOZ ml min 3534 2862 2189 1516 844 171 00 00 01 45 03 30 05 15 07 00 08 45 10 30 12 15 14 00 15 45 Data Editing Nota In Data view double click in the window to enter in Data Editing The software allows the user to edit the data acquired during the test in the following ways e deleting one or more steps e editing row data e input new parameters e data filtering averaging or smoothing e advanced data elaboration Aft
90. e that the system has been configured correctly by setting the right values of gas concentration of room air i e 20 95 O and 0 03 CO of gas mixture contained in the cylinders and the volume of the calibration syringe i e 3 litres Set the reference values using the PC software This operation must be performed only the first time The next times the system keeps stored the reference values entered in this step 1 Select Reference Values from the Calibration menu 2 Type the correct values for the O and CO room air concentration i e 2093 for 20 93 and do the same for the gas concentration of the calibration cylinder Reference values Cylinders x100 Environment x100 02 1604 02 2093 coz 502 coz IE Syringe ml Cancel Van an Default Help 3 Type the volume of the calibration syringe i e 3000 for a 3 litres calibration syringe 4 Press OK button to confirm changes Set the reference values using the Portable Unit To set reference values from the K4 b Portable Unit go to the main menu choose Calibration and scroll tasks up to choose Set Cal Predicted Values type the values using the arrow keys and press Enter to confirm changes Room air calibration vyy Room Air calibration is forced to be performed before each test With this procedure the Note After turning on the system calibrates both gas analyzers according to the Room Air Concentrations unit wait 45
91. earing modality cycle versus treadmill while others may not have the required range of motion in the hip or knee to pedal and may perform better walking Deconditioned weak or elderly persons may have to start the test at a low work level and increase the workload in small increments Also field tests may not be appropriate for those who require strict supervision during testing who do not understand the concept of pacing or who cannot be expected to put forth a good effort More consistent results may be obtained by testing in a controlled environment such as a laboratory setting Creativity when selecting protocols may allow adaptations of commonly used protocols to accommodate athletes competing in specific sports Regardless of the type of exercise and protocol selected the same type of exercise and protocol should be used for repeat testing if between test comparisons are important Chapter 9 Sub maximal Exercise Testing 113 Staffing Test termination 114 K4 b User Manual Staff members should be able to do the following Establish rapport with the subject and make him or her feel comfortable Recognize normal acute and chronic responses to exercise Recognize abnormal signs and symptoms during exercise Provide basic life support measures competently Adhere to established procedures and protocols na Be De Clearly explain test results to the individual Sub maximal tests should be terminated according to ACSM or
92. eat testing e A constant pedal speed throughout cycle ergometry testing e Cycle seat height properly adjusted recorded and standard for each test e The time of day for repeat testing consistent e All data collection procedures standardized and consistent e Test conditions standard e Subjects free of infection and in normal sinus rhythm e Prior to the test no intense or prolonged exercise for 24 hours smoking for 2 3 hours caffeine for 3 hours or heavy meal for 3 hours e Room temperature 18 20 C 64 68 F with air movement provided Chapter 9 Sub maximal Exercise Testing 115 Performing the test In this chapter it is supposed that the user is able to e perform an exercise test e create exercise protocols e view edit and print tests If this is not the case please read the Exercise testing chapter To perform a sub maximal test follow these instructions 1 Create a proper protocol procedural guidelines for several sub maximal testing protocols are provided in ACSM s Guidelines for Exercise Testing and Prescription 6 Edition Philadelphia Williams amp Wilkins 2000 22 29 2 Start an exercise test 3 Perform the test as it were a maximal exercise test ending it when the heart rate reaches the 85 of the Hrmax or it happens an event listed in the section Test termination Display a VO Kg vs HR plot 5 Right click on the graph and select VO submax from the pop up menu PFT Ergo O2 Kg
93. ect the wrinkled tube to the unit through the Flow in connector 6 Connect the optoelectronic reader of the K4 b to the Flow out connector of the Canopy unit 108 K4 b User Manual Performing the test START How to prepare the patient 1 Switch on the Canopy unit If there are no problems the red led on the front panel of the unit flashes for few seconds and the alarm beeps If the led does not flash and or the alarm does not beep the test cannot be performed because the backup battery is exhausted or there is no backup battery When the green led turns on the test can start If the green led does not turn on the red led flashes and the alarm beeps the test cannot be performed because the pump does not work or the mains does not power the system After these checks put the patient in a supine position Place the bubblehood with the vail on the patient s head The tube has to be placed near the patient s mouth Warning Do not place Canopy hood over a patient s head before the tube is properly connected and a continuous flow is applied from Canopy Blower 1 2 3 Enter in the ergometry program Select a patient or add a new one File Patients Select Start test from Test menu Execute Test x Height cm 180 Mode C Gas Weight Kg jan f ECG Gas Il Rest ECG RMR Canopy l Simulated test La Ergometer no one Protocol RMR v Other data Details L
94. ed or smoky places e If saliva is entered in the tube replace it immediately because it lost its functions e Periodically grease the o ring on the connector in order to simplify the flowmeter connection e Replace it every 100 test 6 month The equipment requires easy inspections to be carried out in order to assure a proper electrical and mechanical safety level in the years These inspections are highly recommended after a rough use of the equipment or after a period of storage in unfavourable environmental conditions Referring to the electrical safety it is important to check the conditions of insulation materials of cables plugs and any other visible part by means of simple inspection when the equipment is switched off and adapters or electrical feeders are disconnected from the supply mains Mechanical parts to check are the turbine and breathing circuits Follow these instructions e extract the turbine from the optoelectronic reader e verify by inspection that the turbine axis fits correctly its seats and the blade is strongly fastened on the axis itself it can be useful to shake slightly the turbine in order to note any anomalous movement Check if there are any torn or broken components in the breathing circuits remember that they can create safety risk to patients during tests The fuses can be replaced easily in the following way 1 Open the power supply cover using a screwdriver as shown in the picture
95. ees 92 Create a new predicted parameter 92 Exporting data ze sccss dsctasescesssssccasanesrdeaisssdecsnselecscacgeaeancendezesaies 93 Exporta test an es eating nee 93 DDE with Excel ernten 93 Creating Test Protocols essssuossssensnsuensnnensnsnnssnnensnsunsnsnenssscnnnse 94 Create a new protocol u kek 94 Software configuration sessessssessnnunssnnensnsunsnsnennssensnsunnnnsensnsnnnssnen 95 Data viewing anna Ran nal 95 Select the parameters to view 95 Index 7 Select the parameters to view during the test 95 Sort the parameters i keke keke 95 Steady States naar aa ehh ee esas 95 Customise the Steady State detection criteria 95 Printout reportis isecsieccscedscesscasieessccsceussecsiecsscadscusseassensscudsenssesssec ease 96 Set up the prit t0Ut u keke keke 96 Select parameters to be printed 96 Customise the printout header 96 Electronic reports pdf u eee 97 Print the current Will OW keke keke keke 97 Print the customised report keke ek k 97 Events management during exercise testing 98 Flow Volume lOODS eke keke keke kek k 98 Flow Volume loop during the test 98 O2 COZVS TIME Nein 98 O2 CO2 vs Time during the test 98 O2 Saturati
96. emove the impurities 2 Rinse the mask with energy in running hot water Warning Do not use synthetic or petroleum based products for the masks cleaning Disinfecting the mask It s possible disinfecting the mask following these procedures e Standard autoclaving method Rapid cycles of autoclave lasting 10 minutes at 132 C 270 F Heavy cycles of autoclave lasting 30 minutes at 121 C 250 F Pre vacuum cycles of autoclave lasting 30 minutes at 121 C 250 F Chapter 12 System maintenance 145 e Hetilene oxide method ETO The hetilene oxide doesn t deteriorate the face masks Sterilisation by this method is not advised unless sufficient data is available regarding the time required for complete out gassing of residual ETO If you use this method follow carefully the instruction provided by the maker of the sterilising product e _Pasteurisation The disinfecting with hot water is a sterilising method that may be used with the silicone masks Canopy bubblehood option cleaning The Canopy bubblehood must be cleaned after each usage with a soft cloth and a non aggressive as well as not alcoholic detergent RMR reader option cleaning The disinfecting procedure is easy and may be performed any time the user needs to do it by keeping attention to some precautions 1 Disconnect the sampling tube from the reader 2 Plunge the reader only in a vessel containing disinfectant solution for 20 minutes circa
97. en the message Connect the sampling line and press Enter appears press Enter and start breathing at a constant rate Synchronise the breath inspiration and exhalation with the acoustic signal 5 After some cycles a message will appear confirming the delay calibration and the new values will be shown on the display Press Cancel to return to the previous menu Print the calibration report In the Calibration 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 must run a new calibration before testing Chapter 4 Calibration 53 Turbine calibration The system uses a turbine flowmeter It opposes a very low resistance to flow lt 0 7 cmH O l s to 12 Vs The air passing through the helical conveyors takes a spiral motion which causes the rotation of the turbine rotor The rolling blade interrupts the infrared light beamed by the three diodes of the optoelectronic reader Every interruption represents 1 6 turn of the rotor this allows to measure the number of turn in the time There is a constant ratio between air passing through the turbine and number of turns This allows a
98. entative plots are the Flow Volume and Volume Time loops By comparing FVC FEV1 and FEV1 FVC values the software allows an automatic interpretation concerning the levels of obstructive and or restrictive disorders The flowmeter has to be disconnected from the breathing valve The patient should wear the nose clips The turbine has been recently calibrated ATS recommends a daily calibration The paper mouthpiece or the antibacterial filter is properly connected to the flowmeter through the corresponding adapter For hygienic reasons we strongly recommend the use of a bacterial filter If a kid must 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 BACK Test encouragement Select Forced Vital Capacity pre from the Test menu and wait for the green led is prompted on the right side of the screen Explain the manoeuvre to the patient and press the F2 key Wait some seconds and perform the test After having performed the test press F3 or wait for the automatic end 5 seconds without flow so that the software displays the F V and V t graphs the main parameters and the predicteds values In order to visualise the F V and V t graph and the main parameters press the following buttons view Flow Volume graph view Volume Time graph DATA view data of the test Press Alt F3 to stop the acquisition discarding t
99. epeat the test until it is correctly performed ATS recommends 3 times 8 Press Exit to visualise the test list carried out during current session together with the results of the main parameters 9 Select the test that you want to save the Best Test according to the ATS criteria is highlighted as default and press OK Bronchial Provocation protocols Database 132 K4 b User Manual The response to a bronchoprovocator 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 bronchoprovocation protocol in a database is useful to simplify and automate the sequence of operations that the Physician need to execute during the bronchoprovocation tests The typical sequence of activities to carry out a bronchoprovocation test are 1 Typing and storing a bronchoprovocation protocol in the database usually only once 2 Selection of protocol among the list of the ones already present in the database before carrying out the FVC post tests the selection of manual protocol allows to execute the test fully manually 3 Performing the Post tests Enter a new Bronchial provocation protocol in the ar
100. er data elaboration it is always possible to restore the original data file by pressing the Restore button If you want to save permanently all the changes press Overwrite being aware this function replaces the original test definitely Editing values and input numerical values 1 Choose Edit test from the Test menu 2 Select the cell containing the value you want 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 Edit Test Phase Time Ti Te IV vT O2exp ee 00 00 03 2 35 0 69 0 912 154 4 re 2 lt Hei Set r dans A SECS SS ey KE yan se xir ez c cey s e s C en ek W vq Veri ee 2 Warm up 00 00 06 1 40 2 22 0 93 1 133 192 0 ee TEN era 00 00 11 1 39 2 49 0 90 1 121 190 5 4 Recovery 00 00 15 1 41 2 40 0 86 1 018 172 8 Ja Marker 10 00 00 19 1 40 2 54 0 87 1 020 j 172 9 00 00 23 1 48 2 57 0 90 1 041 1 176 3 ok 00 00 27 1 41 2 61 0 84 0 935 159 0 j i Cancel 00 00 30 1 44 2 43 0 82 0 919 156 5 R a a Ae aa kn W a aA wa See hande ET q ae Mia Qu ede B Sand B Preview 00 00 34 1 43 2 46 0 84 0 947 161 6 a Filtering 00 00 38 1 46 2 29 0 83 0 960 164 5 3 Delete step 00 00 41 1 40 2 25 0 80 0 936 160 7 k N En Advanced 00 00 45 1 44 2 25 0 78 0 956 163 6 ee ee Restore 0
101. erating sequence E keke keke k ke k k 139 Run a test with GDS u keke keke 139 Monitoring GPS parameters in real time 140 Pulse Oximeter option sssscossssensnnunssnnensnnnnsnsnensssensnsnnnssnen 141 Operating Sequence ern a a E e eW T KE VER 141 System maintenance 143 System maintenance eosssssnssssnnssssnnnssnnnssnnnsssnnnssnnsnssnnnssnnnnssnnnnne 144 Cleaning and disinfectlOn keke k 144 Preparing the disinfecting solution 144 Cleaning the turbine flowmefter eee 145 Precautions during the cleaning of the turbine 145 Masks cleaning and disinfection Eu eee 145 Disassembling the different parts of the mask 145 Cleaning the mask eke 145 Disinfecting the mask u kk 145 Canopy bubblehood option cleaning 146 RMR reader option cleaning eee 146 Precautions during the cleaning of the turbine 146 Two way non rebreathing valve cleaning option 146 Mixing chamber cleaning and disinfection option 146 Permapure maintenance EE keke ek esne 146 Inspechions una sata nn RR Re mt 147 Replace the fusess 5 3155245045 a a ihn 147 10 K4 b User Manual Appendix 149 Conformity declaration ssscccssscssssccssscccsssccssscccsssccssscossss
102. ercise testing Read carefully the exercise testing chapter Chapter 1 Getting started 17 Environmental condition of use 18 K4 b User Manual COSMED units have been conceived for operating in medically utilised rooms without potential explosion hazards The units should not be installed in vicinity of x ray equipment motors or transformers with high installed power rating since electric or magnetic interferences may falsify the result of measurements or make them impossible Due to this the vicinity of power lines is to be avoided as well Cosmed equipment are not AP not APG devices according to EN 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 e Temperature range 10 C 50 F and 40 C 104 F e Relative humidity range 20 to 80 e Atmospheric Pressure range 700 to 1060 mBar e Avoid to use it in presence of noxious fumes or dusty environment and near heat sources e Do not place near heat sources e Cardiopulmonary resuscitation emergency equipment accessible e Adequate floor space to assure access to the patient during exercise testing e Adequate ventilation in the room Guidance and manufacturer s declaration electromagnetic emissions
103. erformed in the way and with the frequency described e any modification or fixing is carried out by qualified personnel e the environmental conditions and the electrical plants where the device operates are in compliance with the specifications of the manual and the present regulations concerning electrical plants In particular grounding reliability and leakage current suppression can only be assured when the device three wire receptacle is connected to a yellow green return connected to earth ground Attempting to defeat the proper connection of the ground wire is dangerous for users and equipment 10 11 OPR Before powering the system check the power cables and the plugs Damaged electrical parts must be replaced immediately by authorised personnel Large gas cylinders which may be given by the manufacturer or purchased by the customer should be secured with cylinder safety chains or safety stands When removing the protective cap inspect the cylinder valve for damaged threads dirt oil or grease Remove any dust or dirt with a clean cloth If oil or grease is present on the valve of a cylinder which contains oxygen do not attempt to use Such combustible substances in contact with oxygen are explosive Be certain that the materials of the pressure regulators are chemically compatible with the intended gas service before installation Inspect the regulator for the proper connection and note the ranges of the pressure
104. eters and predicted equations trough the Formula Editor tool kit e DDE with Microsoft Excel e Customizing software environments colours printed parameters e Helpon line Chapter 1 Getting started 25 Before starting Before operating the K4 b we strongly recommend to check the equipment and register you as a customer Checking the packing contents Make sure that the package contains the items listed below In case of missing or damaged parts please contact Cosmed technical assistance www Note a Non telemetric version b Internat telemetric version c USA telemetric version d Japan telemetric version Code C00950 01 04 C00952 01 04 C00952 02 04 C00949 01 04 C01599 01 04 C01599 02 04 C00260 01 04 C01570 01 06 C00342 01 12 C02120 01 05 C02200 01 11 A 800 900 001 C02210 01 08 C02910 01 10 C02911 01 10 C02912 01 10 A 661 200 001 A 661 200 002 A 182 320 001 C01460 01 06 A 362 060 001 C01507 01 12 C00659 01 12 A 410 110 002 C02100 01 06 C02100 02 06 C00341 01 12 C01577 01 12 C01929 01 08 C01143 01 98 C01800 01 05 C01509 01 30 C01588 01 20 A 680 023 500 A 680 013 630 A 680 044 500 C01790 01 36 C01999 02 DC C00067 02 94 C01508 02 91 26 K4 b User Manual version Qty 1 ele NI el ele RAW Rey Re ie NM b BRL RL Re Re LN Re LR LR RR Re RR LENO RE NI RL Rl 4 HA KA me e NI N A KA A KA ee ee eee c wi Alme m me me N me KA eeel RAW AW
105. f detecting any coronary artery disease or pulmonary disease Unfortunately maximum exercise tests are impractical because they are expensive require extensive clinical supervision and subject individuals to levels of physical stress that may be unnecessary depending on the objectives of the test Consequently maximal testing is reserved for clinical assessments athletic evaluation and research A sub maximal exercise test costs less and carries a lower risk for the individual Although less sensitive and specific for detecting disease or estimating maximal oxygen consumption correctly performed sub maximal tests can provide a valid estimate of cardiorespiratory fitness 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 following e Complete medical history e Medical contraindications to exercise e Symptoms suggesting cardiac or pulmonary disease e Angina or other forms of discomfort at rest or during exercise e Unusual shortness of breath at rest or during exercise e Dizziness or light headedness e Orthopaedic complications that may prevent adequate effort or compromise the validity of test results e Other unusual signs or symptoms that may preclude testing e Risk factors for coronary heart disease e History of major cardiorespiratory events e
106. f the test or if it is selected View RMR the main results are shown e The average time interval default 10 minutes e Average values of VO VCO R RMR RF VE HR FAT and CHO and predicted values if available Body Mass Index 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 the patient How to modify the average interval 106 K4 b User Manual If the average interval automatically identified by the software is not satisfying for example because the patient was speaking 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 EE BOND J test n 3 oy x EEkc Kcal day 3500 0 J 3000 0 4 2500 2000 1500 1000 D T Tr TT de ana ss 00 00 01 15 02 30 03 45 05 00 06 15 07 30 08 45 10 00 11 15 12 30 13 45 15500 16 15 17 30 18 45 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 r n The print of the current window generates a
107. fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the K4 b is used exceeds the applicable RF compliance level above the K4 b should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the K4 b b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Recommended separation distances between portable and mobile RF communications equipment and the K4 b The K4 b is intended for use in an environment in which radiated RF disturbances are controlled The customer or the user of the K4 b can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the K4 b as recommended below according to the maximum output power of the communications equipment Rated maximum Separation distance according to frequency of transmitter output power of m transmitter W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 17 4 P d 1 17 4 P d 2 33 JP 0 01
108. from Test menu or press Alt F2 r Tests to link 2 Test 1 Temperature C 0 ID code O Date of test 12 07 01 PB mmHg 740 Sex M Time of test 09 49 Humidity 50 Age 25 Duration 00 02 43 Height cm 170 N of steps 71 Weight Kg 70 0 Extimated download time 00 00 03 Preview Farst Brennen Next Last r Link to Progr 5 I ID code default Last name GPS First name TEST Sex M re Find ID code lose 2 4 To be downloaded the test must be linked to a patient If the current patient has already been inserted in the database choose Find and then List select the patient and confirm If the current patient doesn t belong to the archive he must be inserted select Find and then New fill in the fields and confirm Now the download function is available and the test will be filed on the PC 5 Choose the test to link with the First Previous Next and Last buttons and press Download i 6 A status bar will show the data acquisition in progress At the end a message will indicate the end of data reception Receiving test Ta m Receiving test da Chapter 6 Database Management 71 Archive maintenance The software allows to manage files selecting Archive from the File menu It is advisable to perform the archive reorganisation every month in order to free space on the hard disk and or to correct possible errors present within the database It
109. gauges Also examine the physical condition of the regulator including threads and fittings Remove any dust or dirt from the regulator or cylinder valve with a clean cloth Do not install a regulator on a cylinder valve containing oxygen if grease or oil is present on either Such substances in contact with oxygen are explosive Cleaning residue particulates and other contaminates including pieces of torn or broken components in the breathing circuit pose a safety risk to the patient during testing procedures Aspiration of contaminates can potentially be life threatening Use disposable anti bacterial filters or disinfect each part in contact with the patient before each test You must follow all the cleaning procedures in System Maintenance and you must thoroughly inspect the components after cleaning and before each patient test 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 Keep the device away from heat and flame source flammable or inflammable liquids or gases and explosive atmospheres In accordance with their intended use K4 b is not to be handled together with other medical devices unless it is clearly declared by the manufacturer itself It is recommended to use a computer with electromagnetic compatibility CE marking and with low radiation emission displays It is necessary to make the PC connected to the K4 b2 co
110. he end ofthe FVC Test if e the automatic diagnosis option is enabled e the patient s anthropometric data allow the calculation of the LLN Lower Limit of Normal range e 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 Pred LLN Pred 0 8 specifications Quality control K4 b allows a quality test control The calculation has been carried out referring to Spirometry in the Lung Health Study Methods and Quality Control A R R D 1991 143 1215 1223 The messages concerning the quality control are shown at the end of the test To enable disable the quality control click on Enable Quality Control checkbox Parameters manager View Print Sort Customize Hot selected parameters Selected parameters PI r All tests FV Post S955 IF Show description I Show Pre T Show SD IV Show Pred Cancel Apply Help The program allows to calculate a huge number of parameters it is advisable in order to simplify the analysis of the results to view to print and to sort the desired parameters only Select the menu item Options Parameters View Move the parameters to view into the Selected parameter
111. he proper COM button the selected port must be different from the mouse one Units of measurements 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 Ib 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 standard information it is possible to customise some fields user free fields entering and labelling measurements coming from other devices The customisable free fields are e 3 fields in the Patient Card Patient s information e 3 fields in the Visit Card information about the visits e 3 fields 2 numeric in the Test card information about Test Customise the fields In the group User free fields type the desired text in the 9 fields available Chapter 6 Database Management 75 76 K4 b User Manual Recommendations for the exercise testing The evaluation of the cardiorespiratory function Precautions The physical training requires the interaction of physiological mechanisms that allow the cardiovascular and respiratory systems to supply the increasing demand of energy due to the contraction of the muscles During the training the systems are both engaged an adequate answer to the effort is the measure of theirs heal
112. he results Repeat the test until it is correctly performed ATS recommends 3 times Press Exit to visualise the test list carried out during current session together with the results of the main parameters Select the test that you want to save the Best Test according to the ATS criteria is highlighted as default and press OK During FVC manoeuvre you might experience some lack of collaboration with kids or with other patients In this case you may find a good help in using the encouragement software tool Chapter 10 Spirometry 127 128 K4 b 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 A Kit for Windows DINE IS Real Time Test FYC P Test View Window Help Beale F lis 145 134 124 t3 1 104 64 34 8 r PEF 4 j 74 Ser 75 64 a4 s4 44 herso 34 34 ev 24 Wer25 14 lt 2 j 0 T r Sc SE T T 1 14 1 2 3 Nef 5 6 7 avo A 14 Pr 24 T 2 LZ 34 b oF T T T T 41 0 1 2 3 4 54 64 7 For Help press F1 27 07 2001 DINE IS RnB Slow Vital Capacity Important test for assessing COPD chronic obstructive pulmonary disease patients affected by this disease might present a the Slow Vital Capacity could be higher than Perform a SVC test BA ABORT Z CK the Forced one FVC The main pa
113. he sampling line 25 10 p760 F200 F600 _ soo 15 F300 F200 F100 3 The message Gas calibration in progress will appear and a graph will show in real time the O and CO calibration The software runs first the Room Air 50 K4 b User Manual calibration so do not connect the sample plug to the calibration kit until the message Sample reference gas will be displayed At the end of the procedure the message Calibration done will be visualized 4 The dialogue box showing the calibration results will appear press OK to confirm the calibration 5 Remove the sampling line from the kit and close the cylinder Reference gas calibration using the Portable Unit 1 Remove the sampling plug from the flowmeter 2 Inthe main menu choose Calibration menu choose Refernce gas calibration and confirm by pressing Enter Do not breath 02 20 7 C02 0 4 3 The K4 b runs first the Room Air calibration so do not connect the sample plug to cylinder output until the message Sample reference gas will be displayed At the end of the procedure the message Calibration done will be visualized Chapter 4 Calibration 51 Analyzers Calibration Bm E High pressure tube Calibration done 02 16 0 cC02 5 0 4 Exit the Calibration menu by pressing Enter or Cancel 5 Remove the sampl
114. hesesenn te 161 Gas Exchange ReferencesS E eee 161 Indirect Calorimetry eee 161 Spiromeliyauis hielten seen 161 Sub maximal testing L keke e 161 Index 11 12 K4 b User Manual Important notices Intended use Warnings 14 K4 b User Manual The measurement of oxygen uptake during sport or real life activities is of great interest for the development of training programs and the study of their effects on elite athletes or for assessing the efficacy of a rehabilitation therapy A common method for assessing the effects of endurance training is the monitoring of various respiratory parameters during submaximal exercise One difficulty to achieve this goal during sport that cannot be simulated in the laboratory is to use a reliable and valid portable system to measure VO and VCO in a field setting Such a portable apparatus may also be useful to determine the energy cost of many sport and real life activities K4 b is an electrical medical device designed to perform pulmonary function tests It is to be used by physicians or by trained personnel on a physician responsibility Caution Federal law restricts this device to sale by or on the order of a physician This equipment has been conceived with the aim of providing an auxiliary instrument allowing e the formulation of lung pathology diagnosis e important studies concerning human physiology e the collection of important informat
115. ic Headcap Comfort seal L 10 pcs Comfort seal M 10 pcs Comfort seal S 10 pcs Comfort seal paediatric L 10 pes Comfort seal paediatric S 10 pcs Telemetry data transmission The optional Telemetry data transmission allows the researcher to transmit data on line to a PC up to a distance of 800 meters All signals are in real time transmitted via radio to the RU to be saved and displayed on line to any PC Spirometry Kit Optional software and accessories designed for performing screening Spirometry such as Forced Vital Capacity Slow Vital Capacity Maximum Voluntary Ventilation and broncho challenge tests PC configuration required e Pentium II 350 MHz e Windows XP Vista e 64MbRAM e CD drive e VGA SVGA monitor e 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 e Any Mouse and Printer compatible with the MS Windows operative system e PC conform to European Directive 89 336 EMC Chapter 1 Getting started 29 Technical feqtures Portable Unit Memory Display LCD Keyboard Serial Port Power supply Thermometer Barometer Dimensions PU Dimensions battery Weight Receiver Unit Transmission range Battery Dimension Weight PC interface Battery charger Unit Power supply Power consumption Flowmeter Type Flow Range Accuracy Resistance Ve
116. ican Heart Association 1995 91 912 Sub maximal testing Cardiorespiratory Assessment of Apparently Healthy Populations Timothy R McConnell in ACSM s Resource Manual for Guidelines for Exercise Testing and Prescription 4 Edition pp 361 366 Franklin BA ed ACSM s Guidelines for Exercise Testing and Prescription 6 Edition Philadelphia Williams amp Wilkins 2000 22 29 Chapter 13 Appendix 161 162 K4 b User Manual
117. ient data e Edit patient data e Delete patient data Select Patients from the File menu Enter a new patient iW 1 Press New to show the Patient dialog box 2 Enter data of a new patient and press OK button to confirm Patients in archive x Search Tor Find Last name Hew CID code a Progressive End List Cancel Patient Progr 5 Last name GAS ECG First name INCREMENTAL Modify Sex M Delete 0 Find a patient Enter 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 previous patient in the database Edit patient data Select the patient Press Modify in order to edit the patient s data 3 Edit the desired values and press OK to confirm Delete a patient Select the patient to be deleted 2 Press Delete 70 K4 b User Manual Uploading tests from the Portable Unit In telemetry and holter function you could need to upload data from the portable unit via serial port 1 Link up the PU to the PC with the RS232 cable supplied 2 Turn on the Portable Unit 3 Choose Receive Test
118. igible for return unless proven defective Special order items Expendable products Goods held over 30 days from COSMED s invoice date Used goods not in original shipping containers Goods which have been altered or abused in any way 5 The following parts are not covered by warranty consumables fragile glass or plastic parts rechargeable batteries damages at the damages due to use of the device not conforming to the indication reported in this manual Chapter 13 Appendix 151 Repair Service Policy 152 K4 b User Manual Goods returned to seller for Non Warranty repair will be subject to conditions 1 2 3 4 The returned goods need to re enter COSMED together with the customs documents Pro forma Invoice and Customs Paper as requested by the Italian law e The shipment has to be qualified as a Temporary Export e All the goods returned to COSMED without the customs papers will not be accepted For European Community members Pro Forma invoice complete with e Number e Description of the goods e Quantity e Serial Number e Valuein e Number of parcel e Gross weight e Net weight e Reason 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
119. indow 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 the mouse on the position where the graph presents the artefacts click the Right key and keeping pressed the key drag the point on the desired place 5 Ifyou want to cancel the edit press the Left key of the mouse 6 Repeat the above mentioned procedure for the all parameters and press OK Apply the threshold noise suppression 1 Make active a graph or 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 Set a Noise Threshold as a percentage of the parameter value above which any peak will be considered an artefact 5 Press Execute and eventually Undo if you are not satisfied 6 Press OK to confirm Chapter 7 Exercise Testing 91 Customise the parameters The software allows the user to create customised parameters and predicted values derived from the standard parameters the ones that are calculated by default through any mathematical formula Allthe customised parameters can be used freely for viewing and printing purposes Formula Editor v 1 4b Parameters ml min Formula fams Vi Comes Erima Create a new parameter Yue 1 Choose Customise parameters from the Options menu HR 2 Press the New bu
120. ing line from the kit and close the cylinder Gas delay calibration 52 K4 b User Manual The delay calibration procedure is a calibration included in the software due the time alignment between flow and gas concentration measurements is one of the potential problems to consider to assure accurate readings during test The gas delay calibration is the measurement of time required by the gas to reach the gas analyzer For breath by breath analysis it is essential that the instantaneous flow rate must be multiplied by the proper time matched expired gas concentration Although flow can be instantaneously measured gas concentration measurements can be calculated with a delay related both to the time necessary for the gas to be transported to the sensor and to intrinsic characteristics of the analyzer principle Two factors contribute to the time alignments delay K4 b uses a capillary sampling tube with a pump to draw a continuous gas sample into the analyzers The gas transport time depends on the dimensions of the tube and on the pump flow rate Additionally the gas sensors have a response time that must be added to the above delay for calculating the total delay The software of the K4 b by carrying out the Gas Delay procedure calculates this delay and introduces a correction to realign both flow and gas measurements This procedure must be carried out each time some changes occur in the sampling system i e when the sampling tube i
121. inkled tube to the outlet 3 of the valve Fix the mask as illustrated in the picture below Adjust the elastic bands on the head cap as necessary to eliminate possible leaks and create a tight seal around the subject s face Complete the patient preparation as indicated in the chapter Exercise testing Calibrate the analyzers as described in the Calibration chapter Select Test Execute Test or press the icon E or press F2 Select Mixing chamber in the Execute test window and perform the exercise resting test as illustrated in the chapter Exercise testing The mixing chamber 119 120 K4 b User Manual Spirometry Setting spirometry options Spirometry 122 K4 b User Manual The software allows to configure some options selecting Configure from the Option menu Test options x Preferences Spiromet y r Automatic Interpretation r LLN Calculation KARAMA g IV Enable Automatic Interpretation IV Enable Quality Control IV Response graph in logarithmic scale T Print active window FYC in ATS format 2 pages I Reduce scale on small curves Cancel Automatic Interpretation K4 b has the function of interpreting each test performed by a patient visualising an automatic diagnosis The algorithm has been calculated basing on Lung Function Testing selection of reference values and interpretative strategies A R R D 144 1991 1202 1218 The automatic diagnosis is calculated at t
122. intout function is only enabled when the active window title bar highlighted is one of the following objects e Any kind of Graph e Numeric data e List of visit To print the active window 1 Ensure that the active window is one of the preceding objects 2 Select Print Active window from File menu Printing a series of reports Sometimes it is useful to printout automatically a series of reports all tests carried out with the employees all tests carried out in the today s session To print out proceed as follows 1 Select Visit List from the File menu 2 Set the criteria of the visits to be added in the list from to 3 Select Print Report from the File menu Electronic reports pdf 134 K4 b User Manual If an Adobe PDF writer Printer Driver is 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 ASCID xls Microsoft Excel wkl Lotus 123 xpo Cosmed Export a test 1 2 3 Select Export tests from the File menu Select the test to export from the list box and press OK Type the name and the format of the file in the dialog Save as If the ASCII f
123. ion in sport medicine No responsibility attaches COSMED Srl for any accident happened after a wrong use of the device such as e use by non qualified people e non respect of the device intended use e non respect of the hereunder reported precautions and instructions The device the programme algorithms and the presentation of measured data have been developed according to the specifications of ATS American Thoracic Society and ERS European Respiratory Society Other international references have been followed when these were not available All bibliography references are reported in Appendix The present handbook has been developed with respect of the European Medical Device Directive requirements which sort K4 b within Class II a It is recommended to read carefully the following precautions before putting the device into operation The precautions reported below are of fundamental importance to assure the safety of all COSMED equipment users 1 This user manual is to be considered as a part of the medical device and should always be kept on hand 2 Safety measure accuracy and precision can be assured only e 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 e ordinary equipment maintenance inspections disinfection and cleaning are p
124. ise in the list box and press OK numeric values of the various parameters columns corresponding to MMBBOND J test n 2 olx t Rf VT VE voz vcoz VE VO2 VE VCOZ VO2 Kg R Fe02 Feco2 HR vo2 HR Load Feto2 amp hh mm ss b min 1 l min ml min ml min ml min Kg bpm ml bpm Watt 00 00 00 12 2 1 151 14 1 556 505 25 27 7 32 0 90 15 86 4 35 61 9 1 014 79 00 00 06 10 2 1 626 16 6 595 574 27 28 7 84 0 96 16 40 4 20 65 9 1 O 15 61 00 00 10 12 7 0 610 7 7 250 236 31 32 3 30 0 94 16 94 3 70 67 3 7 O 15 88 00 00 15 12 2 0 865 10 6 344 341 30 31 4 52 0 99 16 91 3 91 66 5 2 0 15 83 00 00 21 10 8 1 043 11 3 403 372 28 30 5 30 0 92 16 62 4 01 66 6 1 Q 1 15 54 00 00 26 11 7 0 725 8 5 271 243 31 35 3 56 0 89 17 10 3 48 66 4 1 OG 15 64 00 00 32 10 8 0 721 7 8 259 234 30 33 3 41 0 90 16 93 3 66 65 3 9 0 i 15 59 00 00 37 11 3 0 805 9 1 288 270 31 33 3 80 0 93 117 12 3 62 65 4 4 0 15 63 00 00 43 10 1 0 823 8 3 284 260 29 31 3 73 0 91 16 82 3 81 62 4 5 015 58 00 00 48 11 5 0 769 8 8 285 260 30 33 3 75 0 91 17 05 3 59 63 4 5 015 57 00 00 54 9 4 0 796 7 4 249 225 30 33 3 27 0 90 16 96 3 67 63 3 9 0 15 56 00 01 00 10 0 0 840 8 4 299 261 28 32 3 94 0 87 16 73 3 77 63 4 7 O 15 27 00 01 07 9 1 0 722 6 5 237 203 27 32 3 11 0 86 16 65 3 78 63 3 7 O 15 16 00 01 14 8 9 0 721 6 4 234 199 27 32 3 09 0 84 16 64 3 77 63 Se 0 15 25 00 01 20 10 0 0 728 7 2 263 227 27 32 3 46 0 86 16 63 3 80 64 4
125. ist and an ergometer if you are going to carry out a test with an ergometer 5 Chose Other Data if you want to insert other important informationon the the you are going to perform Execute Test Other Data x 02max m UN g day 0 0 ke VD ml n Cancel FEV1 lJ D 00 BH xj 50 HMVY l min 0 0 RH fluss amp 100 IC 1 0 00 T fluss C 34 User 1 0 00 Matar HD User 2 0 00 Distance jo User a n nn Un meas 6 Select the workspace you would like to see during the test it can be also changed during test check the option box Telemetry to enable software receiving of data and press OK to confirm The software will show blank windows waiting for the first breath Calibrate and start the test 1 Remove the sampling plug from the mask and put the tube far from expired gas concentrations 2 On the Patient s Data menu scroll down the menu and select Start Test from the main menu and press Enter to confirm 3 The message Insert relative humidity will be visualized type the correct value and press Enter Insert relative humidity HR xx 4 The K4 b runs automatically the Room Air calibration The message Do not breath near the sampling line appears Wait for few seconds until the message Calibration done will appear together with a double beep sound Do not breath 02 20 7 C02 0 4 Chapter 5 Operating modes 65 66 K4 b User Manua Connect the sa
126. it 25 00 7 i i i 12 00 a 20 00 4 9 00 i i 6 00 15 00 j i j 3 00 N i 10 00 t hh mm ss oo 02 04 06 08 10 t hh mm ss 00 00 53 O2 Saturation optional Spirogram The O Saturation event is useful to check the quality of SpO signal acquired by the on board Oxymeter if available during the test O2 Saturation during the test 1 Start with normal Exercise test and begin the memorisation of breath values F2 2 Select O Saturation from Test Event 3 As soon as 5 or 6 complete pulses have been acquired press F3 to stop the acquisition The spirogram event allows to display and store the volume time plot F LOOPS F Event Spirogram Til UU a mm sa 00 00 00 10 00 20 00 30 00 40 00 50 t hh mm ss 00 00 06 Spirogram during the test 1 Start with normal Exercise test and begin the memorisation of breath values F2 2 During a steady state select Spirogram form Test Event 3 Acquire volume time plot until the window is filled and press F3 to stop the acquisition View the events after the test Raw data 1 Select Data from the View menu 2 Select the test during which 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
127. laced in different positions Assemble the mask and the flowmeter www Notice In order to preserve items composing the mask it s recommended to grease periodically O rings in the optoelectronic reader with Silicone compound arease K4 b is provided with a turbine flowmeter that can be easily disassembled for allowing cleaning and disinfection 1 Plug the turbine in the mask adapter by pushing and rotating it clock wise till you feel a stop 2 Insert the optoelectronic reader over the turbine and press it till the mask 3 Plug the wind cover as described in point 1 4 Plug the sampling tube in the little hole located in the optoelectronic electronic reader 5 Plug the turbine cable in the Turbine plug control panel of the K4 b Inspiratory valve Turbine Optoelectronic reader Wind cover Ei Sampling plug Using the Ultimate Seal 40 K4 b User Manual 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 e Will not irritate the skin e Contains no adhesives e Has no odour e Will not dry out e Single patient use www Notice Avoid the exposure to the sun Do not put the seal into the water Apply the seal to the mask Apply seal to clean residue free mask only a
128. lculated according to the predicteds in the list Use the predicteds formulae e customised by the user with the option or the customised formulae The Delete button deletes the selected parameter The Copy button stores the selected parameter in memory The Paste button inserts a new parameter from the one copied If the name is not unique the user is asked whether to specify a new name or to replace the existing parameter Page setup Select Page Setup Header Data Margins Footer Printed file name from the File menu All the printouts carried out by the program are preceded by 3 rows of customisable header usually they contain the name and the address of the Hospital using the spirometer 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 Configures the print margins from the borders of the paper The unit of measure is decided in Units of measurements Configures information at the bottom of the page Defines the automatic name to be asssigned to the pdf file if the report will be printed in this format Page setup x Header Data Margins Footer Printed file name Format 232121 r Available fields Zb date of birth zi ID Zd date of test Zl last name Zf first name s sex In the
129. me graph 6 Repeat the test until it is correctly performed ATS recommends 3 times 7 Press Exit to visualise the test list carried out during current session together with the results of the main parameters 8 Select the test that you want to save the Best Test according to the ATS criteria is highlighted as default and press OK Bronchial Provocation Test Bronchodilator test Note Read carefully the contraindications in Chapter 1 Bronchodilators are administered routinely in the b laboratory to determine whether airflow obstruction is reversible Bronchodilators increase airway calibre by relaxing airway smooth muscle The test consists of comparing results between the reference FVC FVC PRE and the FVC POST performed after the administration of the drug Increasing value of 13 15 of FEV1 respect to the basal value FVC Pre is considered as a reversible condition Main parameters are the following DFEV1 pre Change of FEV1 as a percentage of test PRE DFVC pre Change of FVC as a percentage of test PRE DPEF pre Change of PEF as a percentage of test PRE Some authors states that the above mentioned parameters are too dependent from the FVC Pre hence latest reference ERS93 A comparison of six different ways of expressing the bronchodilating response in asthma and COPD reproducibility and dependence of pre bronchodilator FEV1 E Dompeling C P van Schayck et Al ERJ 1992 5 975 981 recommend the following paramete
130. metria em uma amostra da popula o brasileira adulta da ra a negra J Pneumologia 1996 22 165 170 Neder JA Andreoni S Castelo Filho A Nery LE Reference values for lung function tests I Static Volumes Brazilian Journal Medical and Biological Research 1999 32 703 17 Neder JA Andreoni S Lerario MC Nery LE Reference values for lung function tests II Maximal respiratory pressures and voluntary ventilation Braz J Med Biol Res 1999 32 719 27 Thai Wanchai Dejsomritrutai Khun Nanta Maranetra Kittipong Maneechotesuwan Nitipatana Chierakul Jamsk Tscheikuna Tasneeya Suthamsmai Arth Nana Benjamas Chuaychoo Phunsup Wongsurakiat Suchai Charoenratanakul Wilawan Juengprasert Chana Naruman Reference Spirometric Values for Healthy Lifetime Nonsmokers in Thailand J Med Assoc May 2000 83 457 466 DLCO Standardized Lung Function Testing Official Statement of the European Respiratory Society The European Respiratory Journal Volume 6 Supplement 16 March 1993 Compilation of reference values for lung function measurements in children Ph H Quanjer J Stocks G Polgar M Wise J Karlberg G Borsboom ERJ 1989 2 Supp 4 184s 261s Reference Values for Residual Volume Functional Residual Capacity and Total Lung Capacity ATS workshop on Lung Volume measurements official statement of the European Respiratory Society J Stocks Ph H Quanjer ERJ 1995 8 492 506 Single Breath Oxygen Test Buist SA Ross BB
131. modes sssssssssssssssssssssssssscssssssssssssssssssssssssess 60 Holter Data Recorder unsenseerseerseessneeneeennensenenne a d 60 Telemetry Data Transmission option 60 Serial Laboratory StatioOn u eee ke 60 Portable Unit User Interface diagram H 61 Holter Data Recorder Mode ssss000rsssnsnussssnnnnnensnnnnnsssnnnssnsnnnnnes 62 Operating sequence L E keke keke nennen 62 Warming up the System eekek k 62 Enter new patient ueseeesssessesnsensennneenneennennennnennennenn 62 Calibrate and start the test EL ee 62 Stop the test nn dn la lel n QAN de 63 Transferring test to D ekek k 63 Telemetry Data Transmission Mode essssessssuosssnensnnnnsssuenssncnse 64 Operating sequence kek k k nennen 64 Warming up the system ek nenn 64 Connect the receiver unit to the PC 64 Enable transmission E keke k 64 Enter new patient cccceccccsseesceesseeseeeseeeseeneeneenseens 64 Enable reception on PC e eeekek k 65 Calibrate and start the test 65 Stop the test seietan melay Dav en j beden nn 66 Transferring test to PC oii Kiyyl didi ny ye l ra na d 66 Serial Mode 5i i 4 4 545 2545545ss5 ses so a ae sa eW sae ke dey k
132. mpliant with EN 60601 1 by means of an isolation transformer The K4 b needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the section EMC Portable and mobile RF communications equipment can affect the K4 b Use only the cable and accessories supplied with the equipment The use of accessories and or cables other than those supplied may result in increased emissions or decreased immunity ofthe equipment The K4 b should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary the K4 b should be observed to verify normal operation in the configuration in which it will be used Graphical symbols used in accordance to present specifications are described here below Equipment type B EN60601 1 Equipment type BF EN60601 1 Danger high temperature OFF ON Protective earth ground Chapter 1 Getting started 15 N Alternating current 16 K4 b User Manual Contraindication The physical strain to execute the respiratory manoeuvre is contraindicated in case of some symptoms or pathology The following list is not complete and must be considered as a piece of mere information Contraindications for the Spirometer tests Absolute contraindications For FVC VC and MVV tests e Post operating state from thoracic surgery For FVC tests e Severe instability of the airways
133. mpling plug to the optoelectronic reader Some values Heart Rate R VO VCO will be shown and updated each breath on the control panel display The message Press Enter to start the test will be displayed each 10 secs You can switch to different values by moving the Up and Down key After having pressed the Enter key the test starts but the K4b2 is not storing data In this phase the PU is checking the main parameters and you can visualize it on the PU display by the time is blinking mm gz THE xwo V Z2 xc xEB x xxwx T To start storing data press another time the Enter key You can check the storing phase because the time parameter don t blink anymore Press Enter to VO2 x xx R x xx Stop the test To stop the test press Cancel The message Press enter to stop test will appear press Enter to stop the test Transferring test to PC If some interferences should occur during test execution by telemetry some breaths could be lost The software shows a message on the status bar warning that some steps missed Since K4 b stores every time the complete test in the memory it is possible to download the test later to the management software to recover all lost data 1 Turn the K4 b on 2 Connect the K4 b to the PC by the serial cable enclosed in the equipment 3 Run the K4 b software and choose Receive Test from the Test menu r Tests to link 2 Test 1 Temperature C 0 ID code D
134. must be done for avoiding interferences between cables vv Notice Fix all cables with the velcro strips provided with the equipment 42 K4 b User Manual 1 2 Fix the heart belt to the patient s box thorax Fix the K4 b unit to the front of the harness Do the same operation with the battery on the back Connect the battery cable to the 6V plug of the K4 b control panel Be sure that the red plug that repairs the plug from water or sweat drops is on the Portable Unit side Connect the antenna cable to the Antenna plug of Portable Unit control panel Insert the heart frequency receiver and temperature probe cable in the HR Temp plug placed on the control panel Insert the male connector of the turbine in the Turbine plug on the control panel Fix the power supply cables antenna and turbine on the right side of the jacket with the velcro stripes provided in the equipment Fix the heart frequency probe on the left side Note USA and Japan versions differ from the picture because of the antenna placement Connecting the K4 b to the PC K4 b can be connected to any PC provided with serial port in order to monitor on line physiological data during any kind of activity Connect the Portable Unit to the PC Connect the K4 b Portable Unit to a serial port available in the PC Be sure to set the K4 b software to the proper serial port for the transmission A 322 py 7 K4 serial plug
135. n accurate measure of flows and volume The turbine flowmeter doesn t need daily calibrations as it is not affected by pressure humidity and temperature To work properly the turbine only requires the rotor to rotate freely without any friction that might be caused by dust that can be easily avoided with an ordinary cleaning procedure see 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 s possible to check the calibration of the turbine flowmeter even at relatively long intervals i e 1 month The calibration procedure assures valid and verifiable results within a 3 accuracy The calibration syringe The 3 litres calibrated syringe is included in all the Quark PFT line with the exclusion ofthe PFT 1 model 3 litres calibration syringe P N C00600 01 11 Turbine calibration for ergospirometry tests 54 K4 b User Manual Before starting the calibration procedure be sure that the turbine type is properly selected Please select on the portable unit 1 Settings 8 Turbine 18 28 and set Turbine 28 If the calibration is performed through the PC in the calibration program selec
136. nd follow the instructions below 4 Remove the plastic tray from the bag Peel off clear film and retain for later use While holding tray align the nose area of mask to nose area of Ultimate Seal gel Press together and roll mask down over the surface of the gel seal attaching it to the mask and releasing it from the tray If needed adjust the position of the seal aligning it with the outer perimeter of the mask sealing surface The mask 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 on the mask When the seal becomes discoloured or opaque approximately two weeks dispose of the current seal and replace it with a new one Assembling the flowmeter for spirometry tests In case the spirometry kit option is purchased assemble the turbine as shown in the illustration below Spirometry mouthpiece adapter Turbine Optoelectronic reader Cover wind EI I Chapter 3 Installation 41 Fixing the K4 b to the patient www Notice Be sure to fix the Heart rate probe on the left side while the other cables have to be fixed on the right side This
137. nd human health The crossed out wheeled bin means that the product must be taken to separate collection at the product end of life Converting factors configuration You can edit the parameters shown in Control Panel by selecting Control Panel from the Calibration menu in the calibration program then pressing the button by side Configuration parameters x _ r Raw data Name 0x0002 Ambient temp 0x0003 Internal temp 02 0x0005 Barometric press R razan 0x0006 Analyzers press Unit of meas Factor Precision 0x0007 Battery voltage B 01 0x0009 Heart rate 0x000A Turbine Flow z Base line mY 24 0x000B Turbine Volume Y m BL G Cancel Gain ins j D04 ___Cancel Gain exp 1000 Help 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 Chapter 13 Appendix 155 Calculations references VO and VCO Energy Expenditure and Fuel Selection in Biological Systems The Theory and Practice of Calculations Based on Indirect Calorimetry and Tracer Methods M Elia G Livesey World Rev Nutr Diet Basel Karger 1992 vol 70 pp 68 131 Nutritional Assessment in
138. nd updated each breath on the control panel display The message Press Enter to start the test will be displayed each 10 secs You can switch to different values by moving the Up and Down key 6 After having pressed the Enter key the test starts but the K4b2 is not storing data In this phase the PU is checking the main parameters and you can visualize it on the PU display by the time is blinking mm gz THE xxx V Z2 xr xB x xxwx 7 To start storing data press another time the Enter key You can check the storing phase because the time parameter don t blink anymore Press Enter to VO2 x xx R x xx Stop the test To stop the test press Cancel The message Press enter to stop test will appear press Enter to stop the test Transferring test to PC Once the test is concluded you may download all data stored in the K4 b to the management software 1 Turn the K4 b on 2 Connect the K4 b to the PC by the serial cable enclosed in the equipment 3 Run the K4 b software and choose Receive Test from the Test menu r Tests to link 2 Test 1 Temperature 0 ID code 0 Date of test 12 07 01 PB mmHg 740 Sex M Time of test 09 49 Humidity 50 Age 25 Duration 00 02 43 Height cm 170 N of steps 71 Weight Kg 70 0 Extimated download time 00 00 09 Preview First Previous Next Last r Link to Progr 5 ID code default Last name GPS Find ID code
139. ns that need to be controlled and others that just require documenting at the time of the test During the test the individual is interfaced with a metabolic measurement system by means of a facemask A mouthpiece with a nose clip is also sometimes used but it may create overly stressful conditions to a subject patient Important considerations or conditions to improve the RMR measurement e No food for at least 12 hours and no smoke for at least 2 hours before the test e Maintain quiet surroundings when the test is in progress and normal temperature The individual should not move arms or legs during the test e Medications taken should be noted such as stimulants or depressants e The first 5 minutes of acquisition should be discarded by the computation of RMR e Steady state should be achieved which would be identified clinically by the following criteria 5 minute period when average minute VO and VCO changes by less than 10 average RQ changes by less than 5 e Stable interpretable measurements should be obtained in a 15 to 20 minute test e Renal failure patients requiring hemodialysis should not be tested during dialysis therapy 102 K4 b User Manual Recommendations Before starting an RMR test it is necessary to select and calibrate the turbine used Read carefully the calibration procedure in the Calibration chapter Resting metabolic rate test using the face mask Use the following correction for the dead spac
140. nspired I readings for each stroke Operate syringe x 8E 29261 2936 6 When the display visualizes the message Calibration done the Turbine has been calibrated press Cancel to return to the main menu the new calibration factor will be automatically stored Turbine calibration for the RMR test The turbine used for resting metabolic rate tests is different from the standard one used for ergo spirometric tests Since the correction factors for the two turbines are different before using this turbine it is necessary to select and calibrate the turbine used Please select on the portable unit 1 Settings 8 Turbine 18 28 and set Turbine 18 If the calibration is performed through the PC in the calibration program select File Turbine results and enter 18 in the field Type mm Turbine calibration results Actual Acceptable Range Gain Exp 900 1100 Gain ine 900 1100 Type mm 18 Gain Exp 1000 Gain Ins 1000 Cancel Factory Settings Help At the end of the RMR tests before starting using the standard turbine set 28 in the Type mm field and perform a turbine calibration with the standard turbine Assembling the flowmeter Connect the RMR reader to the syringe by means of the proper adaptor Calibrate the turbine Perform a turbine calibration according to the procedure described above Since the ventilation is very low normally lt 10 litres min the turbine
141. nt repair or issuance of a credit for the cost of a defective product at the sole discretion of COSMED COSMED shall not be liable under the foregoing warranty unless i COSMED is promptly notified in writing by Buyer upon discovery of defect ii the defective product is returned to COSMED transportation charges prepaid by Buyer iii the defective product is received by COSMED no later than four weeks after the last day of the one 1 year limited warranty period and iv COSMED s examination of the defective product establishes to COSMED s exclusive satisfaction that such defect was not caused by misuse neglect improper installation unauthorised repair or alteration or accident If the product is manufactured by a third party COSMED shall make available for the Buyer s benefit only those warranties which COSMED has received from the third party manufacturer s COSMED hereby specifically disclaims any and all warranties and or liabilities arising from defect s and or damage s to and or caused by products manufactured by third party manufacturers Buyer must obtain written authorisation from COSMED prior to the repair or alteration of COSMED products s Failure of Buyer to obtain such written authorisation shall void this warranty COSMED hereby specifically disclaims any and all other warranties of any kind whether express or implied in fact or by law including but without limitation any and all warranties of merchantability
142. ntilation Range Oxygen Sensor O Response time Range Accuracy 16 000 breaths 2 lines x 16 characters waterproof 6 keys RS 232C Ni MH rechargeable batteries 3 hours endurance 0 50 C 53 106 Kpa 170x55x100 mm 120x20x80 mm 4008 800 meters 4x1 5 VAA 170 x 48 x 90 mm 550 g RS 232 120V 240 V 25 W Bidirectional digital turbine 28 mm 0 03 20 L sec jer as 2 lt 0 7 cmH O s L 12 L s 0 300 litres x min lt 150 ms 7 24 O 0 02 O Carbon Dioxide Sensor CO Response time Range Accuracy Humidity absorber lt 150 ms 0 8 0 01 Capillary of Nafion Permapure Power Supply Voltage Power consumption 100V 240V 10 50 60Hz 60W Environmental Sensors Temperature Barometer Humidity 30 K4 b User Manual 0 50 C 400 800 mmHg 0 100 Pulmonary function tests and measured parameters Breath by Breath exercise testing Indirect Calorimetry Symbol VO2 VCO2 Vt FetO2 FetCO2 R VE HR Qt AT VE SV RF FeO2 FeCO2 VE VO2 VE VCO2 VO2 HR VO2 Kg Ti Te Ti Ttot Vd Vt PaCO2 P a et CO2 Symbol EE EE BSA EE Kg FAT CHO PRO FAT CHO PRO npRQ Lactate Threshold V Slope 32 K4 b User Manual Symbol VO LT R LT Time LT VCO VE UM ml min ml min 1 ml beat ml min Kg sec mmHg mmHg UM Kcal day Kcal day m Kcal day Kg Kcal day Kcal day Kcal day UM l m hh mm ss
143. old e The number of consecutive steps that met the preceding criteria are at least Minimum number of steps Steady State x Hinimum n of steps Cancel j_j mun zam T Hu B ze YO2 threshold VE threshold R threshold Customise the Steady State detection criteria 1 Choose Steady State from the Options menu 2 Type the desired values for Minimum number of steps VO threshold VE threshold and R threshold The steps which satisfy these conditions will be highlighted with a yellow bar Chapter 7 Exercise Testing 95 Printout reports 96 K4 b User Manual The software allows the user to printout data and graphics according to 4 customisable reports Further it allows the user to customise a printout header that will be printed in each page Set up the printout 1 Choose Reports from the Options menu 2 Define the desired features of the report and confirm Enabling the option Graphs in one page all the graphs selected in the report will be printed in one page 3 Type the name you want apply to the report and press OK to save changes KZK TEKE T Report n l Printed pages ci ss ss 2 l Test data IV Predicted values un M Lactate threshold Test summary j Parameters Comments M Graphs in one page Graphs Print Y1 Axis Y2 Axis X Axis Nil yE Load j fe More N 2 V HR vo2HR l fe More N32 vo2
144. oluntary Ventilation 130 Performa MVV test asien ai einen 130 Bronchial Provocation Test ssssssssssnsnnnsssnnsnnsssnnnnnnsssnnsnnsssnnnne 131 Index 9 Bronchodilator est egal 131 Methacholine and Histamine Bronchial provocation Tests 131 Perform the test 002 wien Ra ane events 132 Bronchial Provocation protocols Database 132 Enter a new Bronchial provocation protocol in the ALCMIVES une ee tik taka rrr 132 Viewing reSUltS icisccsssccovssscessceovseccossesossccceseessbessdecssscsseseoaseceonessoaes 133 Tests of the current patient EE e 133 Delete test a Hanser epiner 133 Printing SOL Ss i do csescccesseescacscavscdegssassesesassscogesesesecessscoseseecesveossss 134 Printing RepOLIS 1i5 Xala ra EREN Hes rasant 134 Printing the active WindOW uE keke kek 134 To print the active window 134 Printing a series Of repOTS L Eek kek kek 134 Electronic reports pdf uu eke ek 134 Export datan a sien nee een a 135 Export itest an tens ungerengaee 135 External devices 137 GPS 5 s25454 506 a 4 2a2 k 02040045025 00 sessast osoita aa U WERA ca S REWE Z cek B Ge 138 GPS initialisation lt k Ay G i555 6 5eybe ce Ek keran eel ked 138 Initialize th GP Si yyi Warin ease keka are 138 Fixing the antenna to the subject 138 Op
145. on optional eke keke 99 O2 Saturation during the test L er 99 SPIro STAM EN V N N Dr rr yr 99 Spirogram during the test ke 99 View the events after the test 99 RAW ates seza y eken k yee ernennen msn 99 Save Raw dala 4 4 zry l2 dekle ky ee 100 Resting Metabolic Rate Test 101 Metabolism ii i yi x 0 4 555 28044 5ik n SekaVEn awE e v SEW EWEN sa V n ER SERE E RSS d 102 Total Metabolic Rat Luke kek k k 102 Resting Metabolic Rate RMR nennen 102 Importance to measure RMR nennnennnsennenennnn 102 Measure of the rest metabolic rate with indirect calorimetry 102 How to perform a RMR teSt E eke kek ek keke 102 Recommendations s000ssssssnnsessonnnnnnnsnnnnsnnnnssssnnnnnnnssnnnnnnnns 103 Resting metabolic rate test using the face mask 103 Resting metabolic rate test using the canopy option 103 Performing a test using the face mask 104 C libr ti ns an e nnd DA Hen 104 How to prepare a patient keke ek 104 Start the Lest nn nase ee EEES 104 Viewingithetest essen naar el 106 How to modify the average interval EE U 106 PET banek nb zanan Ki Ken oe nayne Nase fen RAN Pee KA Wer inn e An ees 107 Performing a test using the canopy option
146. or operator Prior to the device cleaning disinfection and inspection it is necessary to switch off the device and to disconnect adapters from the supply mains In order to guarantee the highest accuracy of measurements we recommend you to disinfect the turbine periodically Use disposable anti bacterial filters or disinfect each part in contact with the patient before each test Cleaning and disinfection 144 K4 b User Manual Cleaning and disinfecting instructions are of fundamental importance to control infections and assure patient safety In fact aspiration of residue particles and contaminated agents are life threatening In this handbook we strongly recommend you to follow the rules worked out by ATS and ERS see Lung Volume Equipment and Infection Control ERS ATS WORKSHOP REPORT SERIES European Respiratory Journal 1997 10 1928 1932 which are summarised as follows e Accessible internal as well as external surfaces of equipment exposed to expired gas should be washed and disinfected prior to testing of subsequent patients e Liquid disinfection can be used if the equipment is well cleaned first no droplets of saliva sputum remain e Disposable gloves should be worn when handling mouthpieces when cleaning equipment exposed to saliva or sputum and especially when drawing blood e Laboratory staff should wash hands prior to testing of each patient e Adopt particular precautions when testing patient
147. or press the Esc key to cancel changes Use of the mouse e To move the cursor among fields move the mouse on the desired field and left click e 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 Some windows are provided with scroll bars that help to see data exceeding the window space available e To move the scroll bar row by row click the scroll arrows at the end of the scroll bars e To move the scroll bar page by page click on the grey area at both sides of the scroll fields COSMED K4 b Help is a complete on line reference tool that you can use at any time Help is especially useful when you need information quickly or when the user manual is not available Help contains a description of each command and dialog box and explains many procedures for accomplishing common tasks To get the Help on line press the F1 key To know the software version and the serial number of the software select About from menu Chapter 3 Installation 45 46 K4 b User Manual Calibration Gas calibration procedures The system can be calibrated according to the following procedures 1 Room air calibration 2 Reference gas calibration 3 Delay calibration 4 Turbine calibration The Room air calibration forced by the system before every test consists of a sampling room air It updates the baseline of the CO analyze
148. ormat is selected the Text button in the dialog box Save as allows you to configure the separators for character based files With the xpo Cosmed file format it is possible to import data from another K4 b archive Press OK to confirm Select the folder for the export and type the file name Press OK to confirm A status bar will show the file creation Chapter 10 Spirometry 135 136 K4 b User Manual GPS initialisation The GPS operates on information gathered from satellites To gather this information take your GPS on outside and find large open area that has a clear view of the sky a nearby park would work fine The GPS needs to receive at least three strong satellite signals to find your location At the first power on the GPS needs to be initialized the initialisation is a fundamental procedure for obtaining accurate and reliable data and should be performed on a large area where the sky is fully visible After the initial self test is complete the GPS will begin the process of satellite acquisition and tracking The acquisition process is fully automatic and under normal circumstances will take approximately 45 seconds to achieve a position fix 15 seconds if ephemeris data is known Like all GPS receivers COSMED GPS utilizes initial data such as last stored position date and time as well as satellite orbital data to achieve maximum acquisition performance If significant inaccuracy exists in the initial data
149. oscale maximum and minimum values of the graph will be measured automatically Ignore 0 points with 0 value measured won t be shown Not 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 When the active window is a graph or a report in data form it is possible to view very quickly the data or the graph corresponding to that test Choose Current test data if the active window is a graph or Current test graph if the active window is a data report from the View menu Chapter 7 Exercise Testing 83 Viewing predicted values For some parameter it is possible to compare the maximum value measured during the test with its predicted value and the LT value both in percentage and absolute View predicted values h i i Predicted from the View menu o Choose NORMS BOND J test n 1 Predicteds MHE t hh mm ss 00 14 13 Load Watt 450 vo2 Wass ml min 3534 119 24 VO2 Kg Wass ml min Kg Sage 46 50 39 00 119 24 VE L min u 139 0 161 3 86 19 Rf b min see 34 2 50 0 68 45 vT 4 48 2 81 159 30 R _ 1 82 __ VO2 HR ml bpm __ 24
150. pply 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 Holder of the treatment The holder of the treatment is Cosmed Srl Via dei Piani di Monte Savello 37 Pavona di Albano Laziale RM The responsible of the personal data treatment is indicated in the documentation stored by Cosmed Srl itself Customer rights In accordance with art 7 ofthe Law you can a c obtain confirmation of the existence of your personal data and their communication in intelligible form obtain e updating correction or integration of your data e deletion or transformation in anonymous form of your personal data deny your consent to the treatment of your personal data These rights can be exercised directly requesting in writing to the holder of the treatment Chapter 13 Appendix 153 Waste of electrical and electronic equipment 154 K4 b User Manual K4 b is an electronic equipment and can not be disposed as unsorted municipal waste Electric and electronic equipment according to European Directive 2002 96 EEC must be collected separately Otherwise it can cause dangerous consequences for the environment a
151. pulation J Roca J Sanchis A Agusti Vidal F Segarra D Navajas R Rodriguez Roisin P Casan S Sans Bull Eur Physiopathol Respir 1986 22 217 224 Nhanes IH Spirometric reference values from a sample of the general US population John L Hankinson John R Odencrantz and Kathleen B Fedan Am J Respir Critr Care Med 1999 159 1798 187 Pneumobil Brazil Valores extraidos do Programa Pneumobil Brasil para a Tese de Doutoramento do Dr Carlos Alberto de Castro Pereira Boehringer Gutierrez Chile Gutierrez et Al Reference values for Chile population Knudson Morris and Bass The maximal Expiratory Flow Volume curve Knudson et al ARRD Vol 123 p 659 664 1981 Spirometric Standard for healthy non smoking adults ARRD Vol 10 3 p 57 67 1971 Pereira Brazil Pereira CAC Barreto SP Sim es JG Pereira FWL Gerstler JG Nakatani J Valores de Refer ncia para Espirometria em uma amostra da populag o brasileira adulta Jornal de Pneumologia 1992 18 10 22 Mallozi MC Valores de refer ncia para espirometria em criangas e adolescentes calculados a partir de uma amostra da cidade de S o Paulo Valores finais publicados em Pereira CAC Lemle A Algranti E Jansen JM Valenca LM Nery LE Mallozi M Gerbasi M Dias RM Zim W I Consenso Brasileiro sobre Espirometria Jornal de Pneumologia 1996 22 105 164 Scalambrini Costa F Scueiri CEB Silva Jr WC Pereira CAC Nakatani J Valores de refer ncia para espiro
152. r and the gain of the O analyzer in order to match the readings with the predicted athmospheric values 20 93 for O and 0 03 for CO The Reference gas calibration recommended to be carried out daily consists of sampling a gas with a known composition i e 16 00 for O and 5 00 for CO from a calibration cylinder and updating the baseline and the gain span of the analyzers in order to match the readings with the predicted values i e 16 00 for O and 5 00 for CO The Delay calibration recommended to be carried out ones a week or whenever the sampling line is replaced is necessary to measure accurately the time necessary for the gas sample to pass through the sampling line before being analyzed The Turbine calibration recommended to be carried out quarterly consists in measuring the volume of a 3 litres calibration syringe and in updating the gain of the flowmeter in order to match the predicted value Running the Calibration program SI Log file Start the program and choose Calibration from the Test Menu The software runs the Calibration software and the main menu changes accordingly The program creates and updates as default the calibration log file containing the conditions and the results of all the calibrations performed by the user To access the file select File Report File from the calibration program Setting reference values 48 K4 b User Manual Before starting calibrating make sur
153. r using the and keys Select the beginning of the exercise phase t2 moving the mouse on the desired place in the graph pressing the Right key or using the and keys Enter if necessary the initial values for A B and Tau these are the values from which the iterative algorithm starts in order to reach the best values the closer are the initial coefficients to the best ones the higher is the possibility to reach the best fit and press OK You can lock data checking the relative field za V02 t BRUGNOLS H test n 4 VOZ ml min olx 4499 4278 4 4056 3834 0 92 OZ2def ml 713 52 1453 1 exp 178 29 4 _____ ____ 1 j Tau 29 4 sec 3612 TT 3390 3168 2946 2724 2502 2280 2058 1836 1614 1392 1170 948 726 504 282 00 01 00 52 O1 44 02 35 03 27 04 18 05 10 06 01 06 53 07 44 08 36 09 0 91 debt ml 779 2 1819 1409 1 exp t 546 33 1 ATau 33 1 sec t hh mm ss 27 10 19 11 10 12 02 Information about the Test Summary Tip double clicking on the Summary window the function Options Summary is activated by which you may configure the structure of the data Print the data The Test Information dialog box shows all the information concerning environmental data patient data and some data about the test View the Information Choose Information from the View menu Test information xi m Patien
154. rage time interval default 10 minutes e Average values of VO VCO R RMR VE HR FAT and CHO and predicted values if available e Body Mass Index 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 FeO and FeCO values are within the acceptability ranges 20 2 20 8 and 0 5 0 8 respectively and the heart rate is the rest heart rate of the patient How to modify the average interval Print 110 K4 b User Manual If the average interval automatically identified by the software is not satisfying for example because the patient was speaking 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 The print of the current window generates a report similar to the one of the RMR test using the face mask Sub maximal Exercise Testing Introduction Pre test screening 112 K4 b User Manual Several physiological responses to exercise are used to evaluate cardiorespiratory fitness including oxygen consumption heart rate and blood pressure Measuring these variables during exercise particularly maximum exercise increase the chance o
155. rameters measured during SVC tests are EVC Expiratory Slow Vital Capacity IVC Inspiratory Slow Vital Capacity ERV Expiratory Reserve Volume IRV Inspiratory Reserve Volume If the inspiratory expiratory maximal manoeuvre is preceded by a some breaths at tidal volume the software allows to measure the Respiratory Pattern represented by the following parameters VE Ventilation per minute Vt Tidal volume Rf Respiratory frequency Ttot Breath time Ti Ttot Inspiratory time Ttot Vt Ti Vt Ti 1 Select Slow Vital Capacity from the Test menu and wait for the green led is The prompted on the right side of the screen 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 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 To visualise the V t graph and the main parameters press the follow buttons wr au n view Volume Time graph DATA view data of the test Press Alt F3 to stop the acquisition discarding the results Repeat the test until it is correctly performed ATS recommends 3 times Press Exit to visualise the test list carried out during current session together with the results ofthe main parameters Select the test that you want to save
156. report similar to the one in the following page 7 0613 Lidd ssiww yy 4 00 8T ST LT 0 9T SIST 00 abed ST ST FT OE ET ST ZT 00 2T GT TT O 0T SP 60 00 60 ST 80 DE LO SP 90 00 90 ST SO 0E PO SP EO 00 E0 ST Z0O 0E TO SP 00 00 00 72 9 002 20 0Z Op lt I Ssejo Aysaqo 6 6E 0 SE li ssejo Aseqco 6 VE 0 0E ssejo Aylsaqo 6 62 0 92 Iyblemusno 6r2 78l jeulloN g8l gt u ewuepun s uelue 8 S INE p T89 0X33 jew loN 6 ez Zyu 6y INg 607 OHO 969 LWA ZZ wdd YH y OSL 0 9 06 uw 3 AS VLL oz LEL u wyq JJ Z VOL gzz gez ull ZOO LLOL 997 987 utww ZO 8 96 g80 z8 0 H HE VL 6 LELL Vigel Aepy esy YY 0 G6 00 01 08 60 ss ww OUI Pald ped Jsoy 49J79WweJed 070 0 00S 0 D000L 00ST 000 0062Z 0 000 0 00SE 18 9 WOBJE0I0AD 8S10J8XF PEO JuEISUOO SOJON Gee zvu B ING 6b Zvu YSg 020 dxe Sag 00 91 00 ss ww yy uone nq 280 1 dsu SALE ze Sdejs JO N 662 0 ddlS 00 00 9t Isa L 12 9 see Bep e nje edu er 2661 80 81 972p S L LEL Hww ssaid oujeu o eg Jequ nu se S IWVF aweujsiy GNOG aweu jse7 J1 peu soo oju JIeW 3 3 pewsoo mMMM d y4 08SF1 690 6 XEJ Z6F6S L 690 6 l Aley swoy 07000 XOE O d Trs q NSOQo 081 wdg xew YH 0 92 6y1 JuB e 0 821 uuo uB en Op av IN xes 000 poo q AIWSO
157. ress the button by side 2 Select the test that you want to eliminate from the list of the tests referred to the Current Patient and press Delete Chapter 10 Spirometry 133 Printing results Printing Reports J You can print out in three different ways e printing the Report e printing the Active Window e printing a series of reports To print a report of the current visit select Print report from File menu The software will choose automatically the best performed test The standard Report is composed by 1 2 or 3 pages depending if you wish to printout the FVC data and the graphs together on the first page or if you wish to printout the bronchoprovocation response e Selecting the option One page no ATS the report will contain on one page the F V and V t graphs of the best test overlapped on the FVC Post the patient data the notes the diagnosis and the test results e Otherwise the report will contain two pages the first with the patient data the graphs and the diagnosis and the second one with the measured parameters according to the ATS recommendations e The 3 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 Preview Views a report preview on the screen Printing the active window This pr
158. results are due to exercise training rather than variations in testing procedures Some inconsistencies that are inherent may increase variability e Sub maximal heart rate is influenced by time of day eating smoking and familiarization with test procedures e Prediction equations for estimating VO ma may overestimate trained individuals and underestimate untrained individuals e The efficiency of motion during walking running and cycling varies e Cardiac output and VO have a test retest variability of 3 4 Psychological factors such as pre test anxiety may influence the heart rate especially at rates below 120 beats per minute and at low workloads It is not unusual for the heart rate and or blood pressure to be higher at rest than during the initial stages 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 e Dehydration e Prolonged heavy exercise prior to testing e Environmental conditions e g heat humidity ventilation e Fever e Use of alcohol tobacco or caffeine 2 to 3 hours prior to testing Because of these inherent inconsistencies standard procedures for each test must be strictly followed to ensure the greatest accuracy and reproducibility possible e Standard testing protocol e The same testing modality and protocol for rep
159. rs DFEV1 pred Change of FVC as a percentage of predicted value DFEV1 poss Change of FEV1 as a percentage of possible value Methacholine and Histamine Bronchial provocation Tests The most common indication for performing methacholine and histamine bronchial challenges is to diagnose hyperresponsive airways Some patients demonstrate normal baseline pulmonary function despite complaints of tightness wheezing cough and a little or not response to bronchoconstrictor Other patients demonstrate spirometric improvement after use of bronchoconstrictor 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 hyperresponsivness 4 Follow changes in hyperresponsivness When patients with hyperresponsive airways inhale certain pharmacologic agents i e Methacholine or histamine the airways respond by constricting Test consists of executing repeated FVC following the pharmacologic agents inhalation according to an established protocol The fall of the FEV1 parameter is used to calculate the bronchial hyperresponsivness The most important parameter is the PD20 that is amount of drug mg ml that causes a reduction of 20 of the FEV1 respect the basal value without drug Main parameters are P10 Dose that causes a 10 fall of FEV1
160. s changed However it is recommended to carry out this calibration each week in order to prevent wrongs measurements Delay calibration using the PC software 1 Connect the K4 b unit to the PC by the serial port Remove the sampling plug from the optoelectronic reader 2 Run the calibration program and choose Delay from the Calibration menu 3 The message Gas calibration in progress will appear and a graph will show in real time the O and CO calibration The software first runs the Room Air calibration At the end ofthe Room Air calibration the following message appears Analyzers Calibration Ea i Connect the sampling line to the flowmeter and press OK button to continue 4 Connect the sampling tube to the optoelectronic reader and press OK button to start breathing at a constant rate 5 Synchronise the breath inspiration and exhalation with the acoustic signal Continue breathing some cycles until the message Calibration done appears The software open a dialogue box with the new calibration factors and the new delay value Press OK to confirm the calibration Delay calibration using the Portable Unit 1 On the main menu scroll the commands choose Calibration and press Enter to confirm the choice Choose O CO delay calibration and press Enter to confirm 3 The following message appears and the software automatically run the Room air Calibration Do not breath 02 20 7 C02 0 4 4 Wh
161. s list Print Move the parameters to print into the Selected parameters list 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 Predicteds Ea Predicteds set Formula detinition NORMS Description Set current predicteds Name of the predicteds New Save Knudson 83 An ITS LAM Hale fo Copy Mc Barcelona Female j Delete I Modify predicteds a Import Export Cancel Apply Help The program contains a preset of predicted equations but the user is allowed to customise its own predicted sets Select Predicteds from Options menu The window is divided into two forms Predicteds set and Formula definition Predicteds set This form allows the user to manage the set of predicteds The following information define a set Chapter 10 Spirometry 123 124 K4 b User Manual Name identifies the set and cannot be duplicated Description free field Age the adult predicteds start since this age To enter a new set of predicteds click on the New button The field Name must be filled and must be unique To stop without saving click on the Cancel button To save the set click on the Save button To delete a set of predicteds click on the Delet
162. s useful whenever some steps acquired during the test are to be discarded steps acquired before the start of the test patient disconnected from the face mask 1 Choose Edit tests from the Test menu 2 Position the 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 Edit test Advanced x PL a M Time Range C Delete steps From 00 00 02 ar i _ Smoottieg f To 00 05 16 a ei IV All steps Edit parameter r Apply to Parameter Ti M Correction IV All steps C Offset Formula Save settings Load settings Value Formula Steps smoothing Cancel Option Function Delete steps deletes the steps meeting the selection criteria Smoothing applies a moving average to the selected parameter Edit parameter edits a parameter according to the selected criteria Edit parameter Specifications Value replaces the value of the selected parameter with a new one Correction applies a percentage correction to the value of the selected parameter Offset adds an offset to the value of the selected parameter Formula replaces the value of the selected parameter with a mathematical function Time range Specifications From To
163. s with recognised high risk communicable diseases e g tuberculosis multidrug resistant staphylococcus In these cases the clinical need for such testing should justify the risks During the disinfection e do not use alcohol or other liquids containing gluteraldehyde on the exterior surfaces of the equipment Actually they can damage polycarbonates plastics and may produce unhealthy substances e do not use abrasive powders or glass cleaners containing alcohol or ammonia on the plexiglas components of the equipment e donot steam autoclave any parts of the equipment unless it is clearly specified e do not immerse the optoelectronic reader Preparing the disinfecting solution The following recommendations are retrieved from APIC Association for Professionals in Infection Control and Epidemiology Inc APIC Guidelines for Selection and Use of Disinfectants William A Rutala PhD MPH CIC American Journal of Infection Control vol 24 N 4 pp 313 342 August 1996 http www apic org pdf qddisinf pdf As disinfecting solution it is suggested e Sodium hypochlorite 0 5 5000 ppm prepared fresh for use within 24 hours e Sodium hypochlorite 1 10000 ppm prepared fresh for use within 30 days The first solution can be easily prepared by adding 1 part household bleach sodium hypochlorite 5 25 to 9 parts water the second one by adding 1 part household bleach to 4 parts water Cleaning the turbine flowmeter It
164. ssible leaks The mask must be perfectly sealed to the face of the subject especially in correspondence with the nose point C The mask adapt differently according to the face shape of the subject The perfect position is therefore to be determined from subject to subject Start the test 1 Enter in the ergometry program 2 Select a patient or add a new one File Patients 3 Select Start test from Test menu 104 K4 b User Manual Modify test information ID code i 000 Last name BOND First name JAMES n Sex Birth Date oss 0371957 3 Male Ethnic Corr 100 F Female Height em 1 78 0 Temperature C 29 z 2 Mode Height cm fi 78 0 Gas Weight Kg 76 0 Humidity 2 50 Weight Kg 76 0 C ECG HR max bpm fist Press mmHg 760 Gas ECG Best ECG FEV1 I o oo Temp flowm C 34 UN g day 0 0 Hum flowm 2 100 I Simulated test VD mij 0 incremental test cycloergometer Ergometer no one z notes Protocol RMR _Other data Distance 0 00 Unit of meas Workspace RMR Details Load 1 Load Unit of meas Watt Load 2 Real Load Unit of meas watt Cancel ___ Cancel Load 3 Revolution Unit of meas RPM 2 4 Enter the patient s data and select the RMR mode lst picture 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
165. sting 85 Oxygen Kinetic 86 K4 b User Manual Calculate the Mean Value 1 2 3 4 Make active the graph window any Y vs any X graph Right click and select Fitting Choose Mean value in the type combo box Select the first point X1 moving the mouse on the desired place in the graph pressing the Left key or using the and keys Select the second point X2 moving the mouse on the desired place in the graph pressing the Right key or using the and keys Press OK to confirm Note The results of the O2 Fittings function are not stored therefore in order to keep the information print the page using File print 4ctive Window This function is available only if the active window is a VO2 vs time graph and it has a sense only with 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 02 Kinetics Init Fact O2def Be E Selection Init Fact O2debt wena i Al 1657 T E A2 1657 JC is 00 03 50 Ei l 7 Cancel ela gt Gel a Taul 40 0 f C Tau2 400 JC Max attempts oo 2 Run the O2 Kinetic function 1 2 3 Make active a VO vs Time graph window Press the right key of the mouse and select O2 Kinetic Select the beginning of the exercise phase t1 moving the mouse on the desired place in the graph pressing the Left key o
166. such as a destructive bronchial emphysema e Bronchial non specific marked hypersensitivity e Serious problems for the gas exchange total or partial respiratory insufficiency Relative contraindications For FVC tests e spontaneous post pneumothorax state e _arterial venous aneurysm e strong arterial hypertension e pregnancy with complications at the 3 month For MVV test e hyperventilation syndrome Contraindications for Bronchial 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 e Serious bronchial obstruction FEV1 in adults e Recent myocardium infarct e Recent vascular cerebral accident e Known arterial aneurysm e Incapacity for understanding the provocation test procedures and its implications Relative contraindications e Bronchial obstruction caused by the respiratory manoeuvre e Moderate or serious bronchial obstruction For ex FEV1 lt 1 51 in men and FEV1 in women lt than 1 21 e Recent infection in the superior air tracts e During the asthmatic re acuting e Hypertension e Pregnancy e A pharmacology treatment epilepsy Contraindications for Ex
167. t _ Calibration 5 ID code 1TEST Temperature C 22 STPD 0 802 Last name BABETSIS Humidity 21 61 BTPS insp 1 103 a Temp flow C 34 BTPS exp 1 020 n Hum flowm 100 Press mmHg 740 m Patient data r Test Sex M FYC 0 0 00 Date of test 13 09 2002 Age 34 FEV1 I 0 00 Time of test 16 15 Height cm 182 0 IC N 0 00 Test n 21 Weight Kg 88 0 MYY I min 0 0 an BSA m 2 0 O2max ml 0 Duration hh mm ss 00 16 15 HRmax bpm 186 User A 0 00 LT time hh mm ss UN g day 0 0 User B 0 00 VD ml 60 User C 0 00 r Notes Comments il Modify ad Calibration LT 9 r Modify the information 1 Press the Modify button on the Information dialog box 2 Change the values you want to modify and press OK to confirm The software allows to assess the energy expenditure and metabolism substratum In order to measure FAT and CHO type the UN Ureic Nitrogen value into the field All the nutritional parameter will be recalculate considering the UN value 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 ofthe current test active window will be displayed R VT VE voz VCOZ VE VO2 VE VCOZ vo2 Kg R Feo2 Feco2 HR vo2 HR FetO2 Fetco2 b min l l min ml min ml min _ ml min Kg __ bpm ml bpm Phase n
168. t File Turbine results in the field Type mm must be entered 28 Turbine calibration results r Actual Type mm 28 Gain Exp 1000 Gain Ins 1000 Acceptable Range Gain Exp 900 1100 Gain Ins 300 1100 Cancel Factory Settings Help Assembling the flowmeter 1 Connect the Opto reader to the calibration syringe through the adapter 2 Connect the flowmeter to the syringe with the rubber cylinder supplied in the standard packaging www Note If you are using a slow PC we recommend to set an higher refresh time 1 Syringe 2 Silicone tube 3 Adaptor for calibration syringe Note If a bacterial filter is used for the tests do use it also during the turbine calibration Calibrating the turbine Turbine calibration using the PC software After having run the calibration program Select Reference Values from the File menu If your syringe has a different value from the default one 3 litres please enter the correct value 2 Select Calibration Turbine 3 When the Calibration Turbine dialog box appears with the syringe piston 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 Turbine Calibration x Syringe volume 3000 mi Results Exp Z Gain Ins 3002 0 0
169. t any kind of limitation Test can be carried out in the following three different configuration e Holter Data Recorder e Telemetry Data Transmission e Laboratory Station Holter Data Recorder Using the system in the field without the Receiver unit you can store data breath by breath in high capacity memory 1 MB The memory allows to store up to 16 thousands breaths when the test is completed the results can be downloaded to the PC via the RS 232 port provided with the equipment Telemetry Data Transmission option In case the telemetry Data Transmission module is available the K4 b portable unit provided with a small transmitter that allows to send data by telemetry up to a distance of 800 meters All data are transmitted breath by breath to the receiver unit The Receiver Unit must be connected to a PC by serial port it allows the resercher to monitor data on line both in table and graphic format Anyway tests are stored in the memory of the portable unit thus in case of transmission interferences no data are lost By using the system with a PC the software K4 b can also control and synchronise ergometers by using user defined exercise protocol Serial Laboratory Station Although K4 b has been designed for tests in the field it can also be used as a conventional laboratory station as it offers the same features of the best stand alone devices Under this operating mode the K4 b Portable Unit is simply connected to the
170. t before performing the test Keep attention in particular way to the use 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 Chapter 7 Exercise Testing 79 Real time test ABORT STOP Before starting exercise test type a new patient information or choose one from the list of patient in the file As soon as a patient has been entered the software is ready to start a test The name of the active patient is shown on the status bar of the program window Start a test Start the test as described in the chapter Operating modes If you use the device in Holter mode please skip this until Data management The following is applicable only to tests performed with the PC telemetry or serial mode The software environment will change showing a new Menu bar and toolbar while the first data will be displayed in a table format Fie Test View Events ECG Window 2 Demo gt 9 3 J Fast START STOP EVENT MARK Loan WER l v HR 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
171. t the phase and or type the value ofthe load and press OK to confirm Set the markers Select Marker from the Events menu 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 load and press OK to confirm The software allows the user to set the alarm level for the heart rate in order to monitor the patient response Enter the BPM 1 Choose BPM alarm from the Events menu 2 Set the alarm by moving the scroll bar and press OK to confirm It also allows to enable or disable the acoustic alarm by the option Acoustic alarm Chapter 7 Exercise Testing 81 Data management Viewing data Note Double click in the window to open the edit test Creating graphs GRAPH 82 K4 b User Manual As soon as the test has been completed or downloaded all data stored can be retrieved for a complete management Data can be viewed in the following formats Table form each step rows Graphic form Summary Predicted View data in table form 1 Select Data from the View menu graphical presentation on Y1 Y2 X charts results of the test and statistical analysis of the blocks predicted values maximum value measured 2 Select the test to visual
172. tances will require 1 5 minutes to calculate a navigation solution During the acquisition process a message acquiring satellites display of the Portable unit The AutoLocate function can be manually forced selecting GPS AutoLocate from the Calibration menu in order to obtain the best accuracy is prompted on the Fixing the antenna to the subject The GPS Receiver has to be positioned onto the harness of the K4b according the following pictures paying attention to keep the receiver in a position so that the sky will be always visible during the test Some applications such as cycle racing and rowing may require different positioning of the antenna 138 K4 b User Manual Operating sequence Test with GPS module can be carried out with K4 b system in Holter Data Record or Telemetry Data Transmission mode only In addition to the Operating sequence of this mode you must carry out the following operation Run a test with GPS 1 Connect the receiver antenna to the Portable Unit plugging phone jack into the RS232 port at the bottom of the PU Fb y Imonary Gos Exchange COSMED AE ii l DR iid ai 2 Select Settings then External device and press Enter x 3 Enable the GPS option by moving the settings 4 Check the GPS module functionality choosing Calibration then GPS Control and press Enter Display will show latitude and longitude sign on GPS and press Enter to confirm LAT
173. tary 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 Diagnosis of the Visit Card or more quickly retrieving from the diagnosis database the desired one If you want to insert modify or delete a diagnosis from the database select Database Diagnosis from the File menu Spirometry program settings The software allows to configure some options selecting Configure from the Option menu Test options x Preferences Spirometry Graphs Curve n 1 BE r Serial Port Curve n 2 EEE C COM 1 Curve n 3 com gt Curve n 4 M i Curve n 5 Unit of meas Cm Kg IV Grids IV Show InfoTest Inch Lbs al User Free Fields Patient Card Visit Card Test Card User Text User Text user Text User Text user Text user Numeric User Text User Text user Numeric Cancel Graphs All the graphs visualised and or printed can be customised in colours and appearance 1 Select the desired colours of the curves 5 curves max can be overlapped on the same graph 2 Enable or disable the Grid option 3 Enable or disable the Show Info Test option Serial port You must select the serial port RS 232 that will be used to connect the Quark b with the PC To select the serial port click on t
174. th state The increase of the metabolic rate during the exercise needs an appropriate increase of oxygen in the muscles At the same time the CO muscles production must be removed in order to avoid the lactic acid making To satisfy the increase in the gas exchange necessary to the muscles during the exercise is requested the intervention of many physiological mechanisms This process involves lungs the pulmonary circulation the heart and the peripheral circulation The physician has the responsibility that the patient subjects to the test is a suitable person able to execute an effort test Laboratory The room in which the test is performed must be big enough to contain the whole necessary equipment allowing an easier accessibility to the patient in case of emergency In the room should be placed a thermometer and a hygrometer the heart frequency and the perceived values of the effort rise as much as the ambient temperature increases and the variability of the cardiovascular response grows for humidity values higher of 60 Generally it is considered 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 78 K4 b User Manual
175. the Best Test according to the ATS criteria is highlighted by default and press OK reference for the ERV calculation is displayed on the V T graph Chapter 10 Spirometry 129 Maximum Voluntary Ventilation Perform a MVV test ABORT a BACK 130 K4 b User Manual Test for assessing the maximum ventilatory capacity In the past it was commonly performed during routine PF tests however its clinical use declined over the years Today MVV test is most commonly performed as part of the exercise tolerance tests where it is used as an index of maximum ventilatory capacity Test consists in breathing in and out deeply and rapidly for 12 15 seconds The expired volume during this short period is then extrapolated The most important measured parameter is the following MVV Maximum Voluntary Ventilation 1 Select Maximum Voluntary Ventilation from the 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 parameters press the follow buttons l UT DATA view data of the test 5 Press Alt F3 to stop the acquisition discarding the results wer view Volume Ti
176. tton if you want to create a new parameter or Modify if you want to modify an existing one 3 Type the desired value in the fields Name unit of meas integers decimals and 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 Type the desired value in the fields Name unit of meas integers decimals Select the group of the predicted values from the options boxes Select the reference parameter in the Compared to list box A ca Press the buttons in the calculation group and insert the mathematical formulas for men and women adults and paediatrics Press OK twice to confirm Once you create the new predicted you can see it in the predicted window Delete New List Find Copy Import Unit of meas Calculation Male paediatric Integers Im Male adult m Decimals a Female paediatric _ R _ Males limit age ji Female adult Females limit age Related to no parameter E Export Close 7 92 K4 b User Manual Exporting data Note The DDE function is With this function you can export the tests data
177. used for the calibration This is necessary to avoid a small leakage in the sure the Reference values Connections can discharge the bottle in few time of room air and reference 1 Make sure you wait for warm up time before starting calibrating Be sure the high qas are properlv entered WAA ii pressure tube supplied together with the system is connected to the Cylinder plug vv 2 Open the cylinder valve by turning the valve counter clockwise the pressure value an must be set within a range of 300 500 Kpa 3 5 bars or 44 73 Psi requlated to 3 and 5 bar Output Pressure from cylinder must be set between 3 and 5 bars vyv Notice If the pressure regulator is set at a different pressure from what specified room air could be mixed together with reference gas and the calibration could be affected High pressure tube x Recommended gas mixture gt O2 Oxygen 16 CO2 Carbon dioxide 5 N2 Nitrogen Balance After these operation please operate as follows Reference gas calibration using the PC software vvv 1 Connect the K4 b unit to the PC by the serial port Remove the sampling plug from Notice Before calibrating be the optoelectronic reader sure the Reference values 2 Run the calibration program and choose Gas from the Calibration menu of room air and reference qas are properly entered Marl ee er BEE ROOM AIR CALIBRATION IN PROGRESS Do not breath near t
178. wered by the rechargeable battery fixed to the back side of the harness K4 b is also provided with a small display the PU shows in real time the following parameters VT VE VO VCO R HR Rf Marker battery charge level temperature and barometric pressure USA and Japan versions have the antenna not detachable from the portable unit Besides data processing and presentation the Portable Unit has the following functions e Patient data input e Environment data input humidity e Gas and turbine calibration automatic e Memory functions e Tests data management e Data loading to a PC via RS232 Telemetry Data Transmission Receiver Unit RU The RU consists of a small unit connected to a PC through the RS 232 serial port The transmission is achieved by a miniaturized transmitter module located inside the Portable Unit The CU allows the simultaneously charge of the 3 Ni Cd batteries and to supply the PU during the warm up time Flowmeter Gas analysers PC Software The system uses a bi directional digital turbine It opposes a very low resistance to flow lt 0 7 cmH O Vs to 12 Vs The air passing through the helical conveyors takes a spiral motion which causes the rotation of the turbine rotor The rolling blade interrupts the infrared light beamed by the three diodes of the optoelectronic reader Every interruption represents 1 6 turn of the rotor this allows to measure the number of turn in the time
179. what you need View data in graph form 1 Choose Graph from the View menu for creating charts You 2 Select the tests to visualise from the list and press OK 3 Choose the parameters you require on the X Y1 and eventually for Y2 select if can add necessary some of the following options by pressing the more button and press OK to confirm It is possible to access quickly 5 common graphs from the View Graph dialog box V02 VC02 t BOND J test n 2 olx V0 ml min VC Z ml min T T T 2855 4 4 1 4 1 n Er EK KE ee H 3243 Note Double click in the graph window to open the edit test 00 30 01 57 03 24 04 51 06 13 07 46 09 13 10 40 12 08 13 35 15 02 16 29 Right clicking the graph can be exported in bmp file format Customise the graphs 1 With a graph on the screen choose Customise graph from the View menu 2 On the Customise graph dialog box select options to obtain the wished graph Customize Graphs x IV Autoscale From 00 00 15 4 To 00 14 45 4 ye Options rVvo2 p T Ignore 0 Grid I Points only r IV Autoscale IV Autoscale Markers I Squared Min 628 692 Min 513 853 No recovery Max 3950 29 Max 451 9 84 IV Mark points Step 0 0000 Step 0 0000 Option Function Grid on X Y axes show the grid lines in correspondence with x or y axes that make the graph easier for you to analyse data Aut
180. y requirements Quality Assurance UNI EN ISO 9001 2000 Registration n 387 A Cermet UNI EN ISO 13485 2003 Registration n 387 M Cermet Medical Device Directive CE mark MDD 93 42 EEC Notified Body 0476 Class Ha FCC only USA version FCC ID SN7 K4B2T USA transmitter FCC ID SN7 K4B2R USA receiver This device complies with Part 15 of the FCC Rules Operation is subject to the following two conditions 1 this device may not cause harmful interference and 2 this device must accept any interference received including interference that may cause undesired operation Changes or modifications not expressly approved by the party responsible for compliance could void the user s authority to operate the equipment Here are the keynotes used to make the manual easier to read Typographic keynotes Graphic keynotes These are the typographic keynotes used in the manual Style Description Bold indicates a control or a key to be pressed Ttalic indicates a messages shown by the firmware These are the graphic keynotes used in the manual Illustration Description START une shows the button to click in the software to activate the related feature Chapter 1 Getting started 23 System overview Portable Unit PU It is fixed to the patient during the test by an anatomic harness The PU contains the O and CO analyzers sampling pump UHF transmitter barometric sensors and electronics It is po

Download Pdf Manuals

Related Search

Related Contents

AMW004 • Embedded Wi-Fi Networking Solution  Brochure - Rollomatic SA  MANUAL DE INSTRUCCIONES  M06D Videocenter 2  Manual 5082 - Support  Seabreeze SF12TA Use and Care Manual  Samsung AVMCH070EA1 Manuel de l'utilisateur  Denon DRA-685 User's Manual  薬食発第0310003号  Hitachi VT-M290A VCR User Manual  

Copyright © All rights reserved. Failed to retrieve file