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1. 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 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 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 115 116 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 BEI ES R Test View Window Help lelx F s 147 134 124 1 104 I PEF QueF75 44 Verso Qrer25 Gevi For Help press FT 27 07 2001 DINE IS NOM Slow Vital Capaci
2. 09 0247 922 992 g80 G LEZL 00 01 Ped ARP TEOM 0433 BE 607 G 65 cL 06 Leb gez 987 c8 0 L L861 0 60 7say Zyw 6y INg OH9 LWA widq YH uw 3A uiu q 49 ul ZODAN utww ZON 4 Aepy eoy Ye ss ww w Joyoweled 187810618094 851918X3 peo Jue SUOD SeJoN SEZ Cvu 6 ING 6b ev VSg 020 Xe Sd14 00 91 00 ss ww yy voreing 180 dsur SALE ze sdajs jo N 6620 ddlS 00 00 eu sol 12 0 seaubap ainjesadwies L66LIEDIEL EP S L 121 buww ssaid auygwoleg equnu JsaL SANT eweujsu4 GNOG aweujse7 MPSWSOIWVOJUI JIeW 3 N PaWwso9 mmMmj dyy O8SVLE690 6E XEJ Z64GLE690 6 19 Aley oWOY 07000 XO O d TS GSINSO9D 08L wdg xew YH 0 92 B4 1ybiem 0 821 wo jBIeH or 067 W x s 0001 2p09 QI diWsOD Chapter 8 Resting Metabolic Rate Test 101 102 K4 b User Manual Sub maximal Exercise Testing Introduction Pre test screening 104 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 of detecting any coronary artery disease or pulmonary disease Unfortunately maximum exercise tests are impractical because they are expensive require extensive clinical supe
3. 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 C02 Graph ioj x 021i coz i 25 00 12 00 20 00 3 00 6 00 15 00 3 00 10 00 t hh mm ss 00 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 il t hh mm ss
4. Select Archive Navigator from the File menu or press the button by side The Archive Navigator xi Patient Card mo mb r 0971071995 FVC FYC Name 1001 Last 1001 6 11 pf oo1 Birth 0170171975 FEVI 441 Visit Card PEF a Date 09 10 1995 Ga Height cm 180 Weight Kg 70 Age 20 Drug DRUG Diag Borderline Obstruction Description Quality Control Diagnosis 5 Blow out longer FET 100 lt 6 sec chec Notes Oo 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 Tests to Display Smoke 7 No Yes Ex Years fo Cig Day 0 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 current patient from the archive 3 2 A apes EA 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 be
5. 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 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 O concentration and volumes in Ascii file format in a archive apart at a sampling rate of 25 Hz Chapter 7 Exercise Testing 93 94 K4 b User Manual Save Raw data 1 2
6. 29 30 K4 b User Manual VE Vt Rf Ti Te 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 breathing cycle TiTtot ratio l sec Vt ti ratio MVV Maximum Voluntary Ventilation Symbol MVV MVt MRf MVVt UM Parameter l min Maximum Voluntary Ventilation l Tidal Volume during MVV l 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 FEV1 to fall 10 from baseline Provocative dose causing FEV to fall 15 from baseline Provocative dose causing FEV1 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 Pug 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 AAA BER The Battery Charger Unit is provided with a switc
7. 6 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 CO2 0 4 Chapter 4 Calibration 47 4 When the message Connect the sampling line and press Enter appears press Enter and start breathing at a constant rate The software helps to maintain a constant rate by means of a beep sound It is not important to maintain the same rate suggested by the system but it is most important to breath constantly 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 Defa
8. x Y02max MD UN gzday 0 0 Eve m 0 00 VD mi 0 FEY1 1 0 00 BH 5o MVY l min 0 0 RH fluss J 100 Ic 1 0 00 T fluss C 34 User 1 000 gt Marker 5 User 2 jooo Distance o User ajoo 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 Cancel 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 59 60 K4 b User Manual Connect the sampling 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
9. 139 Privacy Information sccccsscccssssccsssccssssccsssccssssccssscssssccsssscoeeses 140 Personal data treatment and purposes nnnnennneen 140 How your personal data are treated 140 The consent is optional but uuneeeneneneeneenn 140 Holder of the treatment 140 Customer Tights ss 08 0 2 RME 140 Converting factors configuration ses 141 Calculations references cccccccssccccsssscsccccssssscccscsssccssesssccsseeees 142 VO and N Ohren armer 142 Anaerobic threshold modified V Slope 142 Oz Kinetics aaaeseseesseesensnnnnennnnsessnnnnnnnnnnnnnnnnnennnnnnnnnnnnnnnnnennnnn 142 ATS 94 recommendations sss0ssrsonenssnnnesnnnnssnnnssnnnnssnnnssnnnnnene 143 ATS recommendations 143 Predicted values 0000s0000ss0nnsesnnnnsnnnnssnnnssnnnnsnnnnssnnnnssnnsssunnnsnnnne 144 ERSS cee am an astra ne fee re A a a ae ee ent 144 R f renc Adult 3 22 22 22 02 tin deed 144 Reference Paediatric ceccecccesseestecstecetecsseeeneeeseens 144 KNUDSON Bin Near 144 Reference Adult Paediatric n 144 TES Whiterace ie een eens 144 Reference Adult Paediatric u ee 144 TTS Black race sise 0 been anne 144 Reference Adult Paediatric een 144 10 K4 b User Manual References Reference Adult Paediatric 144 Multic ntrico de Barcel
10. 23 Options AcceSSOries ccccsccsscocsccssccssccesccesccssccesccsssccescoscoescoesees 24 Accessories rn canbe es Se cubeadie ibe trade re S i Cee 24 Op ONS eisen en beh bese ea RER 24 Telemetry data transmission 24 Spirometry Rite Lee een anne 24 PC configuration required scccsssccsssccssssccssscsccssscccsssccsscseescees 25 2 K4 b User Manual Technical features cccccccscssccsccscceccecceccesccsccscesccscceccsccecceccescsceees 26 Portable Unit sehe asked 26 Receiver Unten nement 26 Battery charger Unit 26 FlOWMeTLeL 5 ten E mer 26 Oxygen Sensor O3 26 Carbon Dioxide Sensor CO 26 Humidity absorber enseenseenseeesneesnenneennennennnnnn 26 Power Supply cscs dies ehe a 26 Environmental Sensors ccccccsseesseceteceteceseeeeeeenseens 26 Measurements 27 Pulmonary function tests and measured parameters ss 28 Breath by Breath exercise testing 28 Indirect Calorimetry 28 Lactate Threshold V Slope 28 OLK INEC Saesnes e ae E E EA N 29 Spirometry Tests Option 29 FVC Forced Vital Capacity 29 VC IVC Slow Vital Capacity and Ventilatory pattern 29 MVV Maximum Voluntary Ventilation 30 Bronchoprovocation Response c cceseceseeeseeeeteeeeees 30 Installation 31 Installation sequence csuscsssesnsennnennnennnennsennse
11. 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 In the dialog box it will appear an estimate of the number of floppy disks you need in order to back up the archives Press OK Restore v 5 4 x Statistics Backup to 60 files 2 Mb Wu Description Browse SER DK Cancel 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 66 K4 b User Manual Spirometry patient s database i AAA 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
12. 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 of the 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 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
13. Last name BOND g First name JAMES Birth Date 06 03 1957 f Fe ae je Ethnic Corr 100 C Female Execute Test en mm Mode Height cm 178 0 Temperature C 25 Height cm 178 C Gas Weight Ka 76 0 Humidity x 50 Weight Kg 76 0 TECG HR max bpm 181 Press mmHg 760 6 Selecting RMR the system set automatically the following options C Gas ECG Rest ECG FEY1 1 0 00 Temp flowm C 34 UN g day 0 0 Hum flowm 100 I Simulated test VD ml 0 E incremental test cycloergometer Ergometer no one Notes Protocol RMR F 0 ther 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 7 Enter the patient s data and select the RMR mode 1st 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 Ureic Nitrogen value NU 2 picture Confirm and start the test by pressing OK Data acquisition with a 30 seconds average 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 Selection of the RMR workspace windows placement The test is fully automatic the softw
14. 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 is 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 Mode Time Range Delete steps From 00 00 02 Smoothing To 00 05 16 Fi gt el W All steps Edit parameter r Apply to Parameter Ti F Value amp Yalue Ir u c a Correction IV All steps C Offset Formula C Formula Save settings Load settings Steps smoothing Cancel a Option Function Delete steps deletes the steps meeti
15. 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 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 comb
16. 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 74 41 46 92 1 87 18 87 4 43 190 16 5 16 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 47 37 11 50 1 25 18 10 3 29 132 5 8 17 50 4 12 st M 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 81 View the report 82 K4 b User Manual Print the current window 1 Be sure that the 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
17. 00 09 Preview First Previous Next Zi Last r Link to Last name GPS Find ID code i TEST Progr 5 ID code default First name 1 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 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 Serial Mode Part List 1 Mask flowmeter 2 Heart Rate belt 3 Battery 4 Harness 5 K4 b unit 6 HR probe 7 Power cable 8 Telemetric Unit 9 RS232 cable 10 Personal Computer Operating sequence 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 prop
18. 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 ID Data Durata Nome paie 20 02 97 00 14 13 Paziente attuale 000002 13703797 00 15 00 BOND J 000003 11704797 00 10 43 TREADMIL T 000004 14 04 97 00 05 16 CARDIAC OUTPUT C 000005 16 04 97 00 07 14 F LOOPS F Report Tutti i test 000006 26 01 00 00 14 45 GAS ECG G Wasserman C Const4plot C ST trends ERS 98 OK Annulla VOZ ml min 3534 2362 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 AAA 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 After 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 T
19. 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 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 Metabolic 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
20. 4 4 015 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 0 15 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 0 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 0 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 0 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 Qi 15 57 00 02 47 10 7 0 821 6 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 1 015 50 RESTES NN WEY Pre 202 an er PR DIU TT I ET Zen CORTE Mii ay Creating graphs The software is provided with powerful functions for creating charts You can add custom graphs to create exactly what you need View data in graph form 1 Choose Graph from the View menu 2 Select the tests to visualise from the list and press OK 3 Choose the parameters you require on the X Y1 and eventually for Y2 select if 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 76 K4 b User Manual AAA Note Double click in the graph window to open the edit test VO2 VCO2 t BOND J test n 2 VOZ ml min lol
21. 6 5 i 5 o VOZ ml min u iim 0 798 1596 2395 3193 3992 gt 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 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 DIE x1 00 00 03 EE P tee IV Add X2 00 16 15 Il Cancel 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 exponenti
22. 84 Advanced Editing uneeerseesseesnesneesnnennnsnnennnne nee 84 Restore the original test 85 Overwrite the original test 85 Customise the desktop ccccccccsccesseesteesecseceeceseeeseeeneenaeens 85 Customise the display colours ccsceceseeseeteeteeeees 85 SMALL un see aie ek eee chants 85 Apply the graphical noise suppression e 85 Apply the threshold noise suppression 85 Customise the parameters cc cccsccesseestecstecetecesecnsecneenseens 86 Create a new parameter ueecnneeenseessnenenneneennnnnne nenn 86 Create a new predicted parameter 86 Exporting data er use are 87 Export a test s een dere ande 87 DDE with Excel 87 Creating Test Protocols sessssessuessuessuensunnsunnsunnsnnnsnnnsunnsunnsunnsee 88 Create a new protocol 88 Software configuration esesssssesssnensnsuensnnensnsnnsnnnennnsensnsnnensnsnensssen 89 Data viewing ea ati 89 Select the parameters to view cccccescesteesteesteeeteeesaes 89 Select the parameters to view during the test 89 Sort the parameters ierni eiei E E KEKE 89 Steady State nin a at Ain a ais AIR 89 Index 7 Printout FEPONES siieicsesc wes cdecccesceskcccscsectecdcecsecsedcccccsececesscdcecesseccecesaces 90 Set up the printout ss 90 Select parameters to be printed 90 Customise the p
23. 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 141 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 Critical Care A Training Handbook Donald C Zavala Anaerobic threshold modified V Slope O kinetics 142 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
24. Initialize the GPS 126 Fixing the antenna to the subject 126 Operating sequence ce eecceesseesseessecssecetecesecnseceseeseeeeeseesneeaes 127 Run a test With GPS 127 Index 9 Monitoring GPS parameters in real time 128 Pulse Oximeter option cccccsscssscsssccesccesccesccesccesccesccsscoesoeess 129 Operating Sequence nnsa aeae E 129 System maintenance 131 System maintenance ssssessecsssosecsecsecsecsecsessecsecsesseoseossessessessesseo 132 Cleaning and disinfection 132 Cleaning the turbine flowmeter 132 Precautions during the cleaning of the turbine 133 Suggested disinfection solutions 133 Masks cleaning and disinfection eneenenneen 133 Disassembling the different parts of the mask 133 Cleaning the mask 133 Disinfecting the mask nnnennennnnnn 133 Permapure maintenance eesennseenseenseenneennnennneennenn nn nnn ne 134 Inspecti ns eu en de rm retarde ue 134 Replace the fuses true aa el rite Asa 134 Appendix 137 Service Warranty ccccccccsscssccssscsscscssscssscssscssscssccsccssossoesees 138 Warranty and limitation of liability 138 Return goods policy for warranty or non warranty repair 138 Repair Service Policy
25. and especially when drawing blood e Laboratory staff should wash hands prior to testing of each patient e Adopt particular precautions when testing patients 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 Cleaning the turbine flowmeter It is necessary to disinfect periodically the turbine for sanitary measures or and for the correct device function As disinfecting solution it is suggested Sodium hypochlorite 5 bleach The disinfecting procedure is easy and may be effected every time the user needs keeping attention to some precautions Turbine Optoelectronic reader Take out the turbine 2 Dip it ina disinfectant solution non alcoholic based for about 1 hour 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
26. 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 41 42 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 analyzer 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 CO3 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 CO2 from a calibration cylinder and updating the baseline and the gain span of the analyzers in order to match the readings with the predic
27. 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 Select parameters to view v x Cancel Restore 2 Manual protocol Es AAA LOAD Tip pressing the Shift key while choosing the marker option will allow you to enter the label for that marker RA 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 Select the phase and or type the value of the 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
28. 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 107 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 4 Display a VO Kg vs HR plot 5 Right click on the graph and select VO submax from the pop up menu PFT Ergo YO2 Kg HR SISINNI E test n 4 ial Eile Test Events View Options Window 2 HSE les ar A TEST DATA GRAPH AT NORMS V02 Kg ml min Kg YU
29. for the customized formulae Hale CHERE Formula Standard Deviation vos Elf ff Adult RE pase Parameter Save Delete Cancel Apply Hei 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 calculated 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 o
30. measurements 69 Using extra fields 69 Customise the fields 69 Exercise testing 71 Recommendations for the exercise testing 72 The evaluation of the cardiorespiratory function 72 PreCautiOns 4305 8 scovecknies sn in Maes ent NE Ph 72 Laboratory realen 72 Ending the testo sus m na 72 Preparing the patient unneenseerseensneenneennennnennennnnnnennnnnn 72 Bef oretesting el tanken neue 72 Patient assent 73 Ending the test rire Bann 73 Real TIME TEST pos seciicccccccceccccssscccccscecesccasscvescescccescecssccssescccssceesestosesess 74 Start a test nn ern E A E ETS 74 Abort the test without saving data nnnennen 74 End the test saving data eeneneneeennenneenn een 74 View data in real time ss 74 View graphs in real time 74 Parameters tO VIEW eeneeeeeeeenseenneennennennneennnnnnnnnennenennenn anne 74 Manual protocol ss 75 Enter Load and Phase nenn 75 Set the marketini r iaeiei ea 75 Automatic ProtOCO ernennen 75 Modify the load during the test 75 Set the BPM alarm nn 8a en us 75 Ent r the BEM daniel te ae 75 Data management essssssesesscscsssscscososcocososcosososeosososcsessosessssosese 76 Viewing dar nn a ee endet 76 View da
31. on only ca Power supply cable Turning on off the portable unit To turn the 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 Short antenna Heart rate probe S Power supply cable 1 AAA EUER Warning During testing make 5 sure to change the battery as Sometime you might need to change the battery during the test To do this you must fast as possible since a long change the battery in the shorter time possible The Portable Unit does not transmit data time could compromise the while it is not powered reliability of measurements 34 K4 b User Manual 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 Tur
32. operation known as AutoLocate This procedure is fully automatic and under normal circumstances will require 1 5 minutes to calculate a navigation solution During the acquisition process a message acquiring satellites display of the Portable unit The AutoLocateTM 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 126 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 ofthe PU E T pou Pa MED 2 Select Settings then External device and press Enter 6639 3 Enable the GPS option by moving the sign on GPS and press Enter to confirm settings 4 Check the GPS module functionality choosing Calibration then GPS Control and press Enter Displa
33. 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 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 influen
34. stored therefore in order to keep the information print the page using File print Active Window Oxygen Kinetic 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 Init Fact O2def Init Fact O2debt Selection z m 1667 re A2 fie Te a 00 03 50 pm B1 735 Ve B2 2393 VC t2 00 11 30 Default Jaul 40 0 re Tau2 40 0 re Max attempts 100 Run the O2 Kinetic function 1 Make active a VO vs Time graph window 2 Press the right key of the mouse and select O2 Kinetic 3 Select the beginning of the exercise phase t1 moving the mouse on the desired place in the graph pressing the Left key or using the and keys 4 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 5 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 VO2 t BRUGNOLS M test n 4
35. 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 by default and press OK The reference for the ERV calculation is displayed on the V T graph Chapter 10 Spirometry 117 Maximum Voluntary Ventilation Perform a MVV test 118 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
36. 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 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 conditions 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 comput
37. 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 b compliant with EN 60601 1 by means of an isolation transformer Graphical symbols used in accordance to present specifications are described here below Equipment type B EN60601 1 Danger high temperature OFF ON Protective earth ground Alternating current Chapter 1 Getting started 15 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 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 Contra
38. visualise the V t graph and the main parameters press the follow buttons 5 Press Alt F3 to stop the acquisition discarding the results 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 AAA 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 reproducibilit
39. 0 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 Notes Comments Hodify Calibration Hi 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 Dai TREADMIL T test n 3 Summary oj x Rf VT VE voz vCoz VE VO2 VE VCOZ VO2 Kg R Feo2 FeCOZ HR vo2 HR FetO2 Fetco2 b min 1 l min ml min ml min ml min Kg bpm ml bpm Phase n 1 Rest Start 00 00 00 End 00 01 08 Speed 0 Load 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 8 0 853 16 9 542 429 28 36 6 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 0 Min 17 5
40. 00 00 21 10 8 1 043 11 3 403 372 28 30 5 30 0 92 16 62 4 01 66 6 1 0 15 54 a 00 00 26 11 7 0 725 8 5 271 243 31 35 3 56 0 89 17 10 3 48 66 4 1 0 15 64 Note Double click in the 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 15 59 window to open the edit test 00 00 37 11 3 0 805 9 1 288 270 ar 33 TEEDE REE EVE AE 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 0 15 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 0 15 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 17 63 4 7 Bi wiss27 00 01 07 9 1 0 722 6 5 237 203 27 32 3 11 0 86 16 65 3 78 63 3 7 0 15 16 00 01 14 8 9 0 721 6 4 234 199 27 32 3 09 0 84 16 64 3 77 63 3 7 0 15 25 00 01 20 10 0 0 726 7 2 263 227 27 32 3 46 0 86 16 63 3 80 64 4 1 0 14 97 00 01 25 11 4 0 798 9 1 349 288 26 31 4 59 0 82 16 44 3 83 65 5 3 0 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 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 0 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 0 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
41. 02 PRO m THE VO2Kg extimated 40 56 Pred 34 21 RF avs 45 00 t Me a DRE Le eee EDIT 60 70 80 30 100 110 120 130 140 150 160 170 180 150 200 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 108 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 Spirometry Setting spirometry options Spirometry 110 K4 b User Manual The software allows to configure some options selecting Configure from the Option menu Test options x Preferences Spirometry r Automatic Interpretation R LLN Calculation RAR g IV Enable Automatic Interpretation IV Enable Quality Control IV Response graph in logarithmic scale I Print active window FVC in ATS format 2 pages I Reduce scale on small curves Automatic Interpretation K4 b has the funct
42. 2 K4 b User Manual Make sure that the package contains the items listed below In case of missing or damaged parts please contact Cosmed technical assistance K4 b standard packaging Code Qty Description C00950 01 04 C00952 01 04 C01599 01 04 C00260 01 04 C01570 01 06 C00342 01 12 C02120 01 05 C02200 01 11 A 800 900 001 C02210 01 08 C02125 01 10 C02135 01 10 C02145 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 02 06 C0034 1 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 680 044 500 C01506 02 35 C01999 02 DC C00067 02 94 C01508 02 91 K4 b Portable Unit only non telemetric version K4 b Portable Unit only telemetric version K4 b Receiver Unit only telemetric version 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 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 5x
43. 20 250V T500mA 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 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 To run the software double click on the icon Registration or select Registration from menu 2 Type the requested information and click Send to send the form via e mail to COSMED How to contact COSMED For any information you may need please contact the manufacturer directly at the following address COSMED S r l 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 23 Options Accessories Accessories Option
44. 25 xpo c cosmed k4b2_en 1 cosmed EJ k4b2_en C1 drivers LI test Save file as type Drives Cosmed format xpo c hard disk c DDE with Excel If Microsoft Excel is installed on your PC you can export a test simply pressing a button on the toolbar To send a test to Excel select Send to Excel from the 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 87 Creating Test Protocols The software allows 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 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 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
45. 6 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 country requirements Quality Assurance UNI ISO 9001 Registration n 387 Cermet Medical Device Directive CE mark MDD 93 42 EEC Notified Body 0476 Class Ila Here are the keynotes used to make the manual easier to read Typographic 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 Graphic keynotes These are the graphic keynotes used in the manual Illustration Description a shows the button to click in the software to activate the related feature Chapter 1 Getting started 19 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 powered by the rechargeable battery fixed to the back side ofthe 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 Besides data processing and presentation the Portable Un
46. 8 0 27 1027 1051 2996 0 13 1027 1051 3006 0 20 1027 Move the calibration syringe 1 Help 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 Turbine Calibration Results Eg Date 26 01 97 Syringe ml 3000 Type mm Gain Exp 1038 Gain Ins 1054 Cancel Default Help FRE 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 inspired 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 50 K4 b User Manu
47. 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 ss THR KExx VO2 HH KEB K xHx 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 Enter to stop the test stop the test press Cancel The message Press enter to stop test will appear press 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 Test Download x Tests to link 2 Test 1 Temperature C 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 Link to Progr 5 ID code default ie Last name GPS Find ID code Close TEST First name 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 t
48. C FiF25 75 FiV1 PIF VEXT PEFT UM 1 1 l sec l sec I sec I sec I sec I sec I sec I sec I sec L I sec l sec l sec ml msec Parameter Forced Expiratory Vital Capacity Forced Expiratory Volume in 1 sec FEV 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 FVC 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 FVC Mid exp flow between 75 85 FVC Mid exp flow between 0 2 1 1 21 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 sl Parameter Expiratory Vital Capacity Inspiratory Vital Capacity Expiratory Reserve Volume Inspiratory Reserve Volume Inspiratory Capacity Chapter 2 Measurements
49. CO VE UM ml min ml min l 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 ml min l min Pulmonary function tests and measured parameters 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 lm Heart Rate LT Calculation VO2 work tau VO2 work tau FVC Forced Vital Capacity Symbol FVC FEVI FEV1 FVC PEF FEVO S 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 FEF0 2 1 2 FiV
50. Cosmed does not assume the liability for interpretation mistakes of this documentation 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 express permission of COSMED Srl COSMED Software can be installed only in one device Excel is a registered trademark of Microsoft Corporation DBIII is a registered trademark of Bordland International Inc Lotus 123 is a registered trademark of Lotus Development Corporation K4 b User manual IX Edition September 2003 Copyright 1998 COSMED Copyright 2003 COSMED COSMED Srl Italy http www cosmed it Part N C01508 02 91 Table of contents Getting started 13 Important inotices sescsescnsscsnechnsisneenneisnnenneisnestenee seinen rennen rennen 14 Intended se 2 een nn 14 Warnings 1 80 iii MR an eee 14 Contraindication essrsssesssonnssnnnnsnnnnssnnnnsnnnnnsnnnnsssnnnnsnnnnssnnnnssnncnse 16 Contraindications for the Spirometer tests 16 Absolute contraindications 16 Relative contraindications 16 Contraindications for Bronchial provocation tests 16 Absolute contraindications 16 Relative contraindications 16 Contraindication
51. K Chapter 7 Exercise Testing 91 Events management during exercise testing Flow Volume loops 8 O2 CO2 vs Time 92 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 that 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
52. New CID code Progressive End List Cancel Patient Progr 5 m ID code 3 Last name GAS ECG First name INCREMENTAL Modify Sex M Delete OK Ti 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 2 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 64 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 from Test menu or press Alt F2 Test Download x r Tests to link 2 Test 1 Temperature C 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 l Extimated
53. OF x 02 ml min oe _vo2 452 1453 1 exp t 178 29 4 VvO2 1819 1409 1 exp t 545 33 1 R2 0 92 R2 0 91 4056 O2def mi 713 lO2debt ml 779 3834 TTau 29 4 sec Tau 33 1 sec Sera a nn 3390 A i i 1 3168 A 2946 oe oo oe oo oe ee oe a Jenene geen 2724 4 7 4 ee a ana en en an nennen 2502 2280 2058 1836 1614 1392 1170 948 726 504 Lx 282 t hh mm ss 00 01 00 52 01 44 02 35 03 27 04 18 05 10 06 01 06 53 07 44 08 36 09 27 10 19 11 10 12 02 80 K4 b User Manual Information about the Test Summary AAA 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 Ea m Patient Calibration ID code 1TEST Temperature C 22 STPD 0 802 Last name BABETSIS Humidity 61 BTPS insp 1 103 3 Temp flow C 34 BTPS exp 1 020 Fee name ARR Hum flowm J 100 Press mmHg 740 m Patient data Test Sex M FYC 0 0 00 Date of test 13 09 2002 Age 34 FE 1 I 0 00 Time of test 16 15 Height cm 182 0 IC i 0 00 Testn 21 Weight Kg 88 0 MWY l min 0 0 en BSA m 20 O2max ml 0 Duration hh mm ss 0
54. 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 Steps z SE Ergometer COSMED Treadmill 7 t Speed Elevation Phase Command 00 00 02 0 0 0 1 no one Xa Eu 00 01 00 0 0 0 2 no one 00 02 00 5 0 0 3 no one x Protocol 00 02 20 10 0 0 no one Name EPA EURE New 00 02 40 15 0 0 no one z 00 03 00 20 0 0 no one x Message Time sec 5 Delete en A m Bi 00 04 00 35 0 0 no one x Messages 00 04 20 40 0 0 no one z F Drive ergometer Generate Edit Add Delete I Relative Increments Initial command no one x Final command no one 2 88 K4 b User Manual 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 v
55. 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 VO2 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 Y A B expf t t1 Tau VO2 rest A B VO2 rest A vo2 work B VO2 work B 25 to start work tl start work t1 stop work t2 end test O2def VO2 workTau O2debt VO2 worktau 2 KT O2 deficit un VO2 l min vo2 work VO2 work O2 debt VO2 rest VO2 rest 0 A d v 1 0 50 to 100 150 tt 200 250 300 time ec ATS 94 recommendation
56. U 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 Ventilation 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 4x 1 5 V AA 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 2 2 lt 0 7 cmH O s L 12 L s 0 300 litres x min lt 150 ms 7 24 Oz 0 02 O2 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 26 K4 b User Manual 0 50 C 400 800 mmHg 0 100 Indirect Calorimetry 28 K4 b User Manual Breath by Breath exercise testing 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 Symbol VO LT R LT Time LT V
57. _ x TA File Test Events View Options Window 2 lj x FEB SO 093 FLE DA Parameter Rest 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 Re 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 60 150 4 HR bpm 72 FAT 59 5 CHO 40 9 BMI Kg m 2 23 9 Normal Elke Keal day 3600 0 1 F 3000 2500 2000 1500 1000 ec hm 5 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 of 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 r
58. al 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 X nv VE ele Re CO2 Trimmer 68 Vv 02 m 3863 m of m jv C02 mv 102 Ambient temp mY 267 M Messages Vv Internal temp m 399 jv Barometric press mV 3712 jv Analyzers press mY 3566 Vv Battery voltage m 3800 F Heart rate msec 678 v Turbine Flow ml sec 312 m Turbine Volume ml 401 wo Using the control panel Deselect all A mV sol alles Flowmeter Buzzer Beh channels Signal refresh pay on off on off time A x gee CO2 Trimmer 68 af E edit parameters Sampling Transmitter name unit pump on off on off Digital CO trimmer Chapter 4 Calibration 51 52 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 without any kind of limitation Test can be carried out in the following three different configuration e Holter Data Recorder e Telem
59. al regression Insert initial factors for the formula Y B A 1 expf t Tau J A 0 13 l Constraint B 0 93 IV Constraint Tau 40 0 l Constraint Max attempts 100 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 Testing 79 Calculate the Mean Value 1 Make active the graph window any Y vs any X graph 2 Right click and select Fitting 3 Choose Mean value 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 Note The results of the O2 Fittings function are not
60. 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 Repair Service Policy 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 39 06 9314580 E mail customersupport cosmed it For USA customers only please contact COSMED USA Inc 1808 North Halsted Street Chicago IL 60614 USA Phone 1 312 642 7222 Fax 1 312 642 7212 email usa sales cosmed it To ensure that you receive efficient te
61. apters 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 3 Replace the damaged fuse s Note Be careful to use proper fuses A 680 023 500 Time lag fuses 5x20 250V T500mA Chapter 12 System maintenance 135 136 K4 b User Manual 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 replacement 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 1 COSMED is promptly notified in writing by Buyer upon discovery of defect
62. are 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 Viewing the test AAA 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 PFT Ergo t amp InfoCenter AJA File Test View Events ECG Window Demo See J gt a v START_STOP EVENT RK a EN vo2veo2t BOND J test n 8 ol x CURE J tost n 8 ioj x vo2 V02 ml min VCO2 ml min VE l min HR bpm g 2529 0 tihh mn ss 00 00 01 00 02 00 03 00 04 00 05 00 06 00 07 00 00 00 01 00 02 00 03 00 04 00 05 00 06 00 07 00 WB BOND J test n 8 ioj xi t R VE vor vco2 VO2 Kg R FeO2 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 pun c 00 00 31 15 0 10 6 386 321 5 08 0 83 16 57 3 78 72 5 3 o 0 38 0 28 ON AAA ns 14 MR ann 207 aon nann 416 20 2074 gt Ef n nan non a a ai LA RH 2 56 Temp C 25 Mixing chamber 00 30 start VE EA SW TE Wesperarisorse K Posta in arrivo m BH QPFT chaptit ce Pr Ergo IS Jasc Paint Shop Pro pa 09 28 At the rend of the test it will be opened automatically a window with the test results PFT Ergo BOND J test n 3 RIVIR
63. ate is the rest heart rate of the patient Chapter 8 Resting Metabolic Rate Test 99 How to modify the average interval Print 100 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 ofthe average Right click and select Edit RMR It is possible to move the start and the end lines BI BOND S test n 3 olx EEkc Kcal day 3500 0 3000 0 0 Te aan 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 15 00 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 The print of the current window generates a report similar to the one in the following page 71 0613 Lidd ss ww yy 3 abed ve Gb 002 20 07 00 8T ST LT 0E 9T GY ST OO GT ST PT O FET GYCT 00 21 ST TT 08 0T 67 60 00 60 ST 80 0E LO ST 90 00 90 ST SO 0E PO ST EO 00 E0 ST ZO 0E TO SFF00 00 00 070 006 OO0T OOST 0002 0052 000 OOSE Ov lt Il ssejo Aseqo 6 6E 0 SE 11 ssejo AIS2qO 6 rE 0 0 ssejo Aylsaqo 6 6c 0 Sc 1Blenueno 6 bz G 8L jeULION g eL gt iuBleauepun SJU9UW9 EYS ING r0s HEV ACE YOL L LOL 8 96 HE VILL 0 S6 Pald JEWJON
64. ation 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 69 70 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 health 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
65. ation 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 96 K4 b User Manual Recommendations 1 Since the ventilation is very low normally lt 10 litres min the turbine calibration has to be performed with very slow manoeuvres each complete manoeuvre in about 10 15 seconds to obtain the best accuracy 2 Use the following correction for the dead space Vp 50 ml for the small mask 60 ml for the medium mask 70 ml for the large mask Chapter 8 Resting Metabolic Rate Test 97 Performing a test 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 Start the test 98 K4 b User Manual The patient interfaces with the equipment by means of a face mask like in the stress exercise The mask has to be tight to the face in order to avoid any air leakage 1 Enter in the ergometry program 2 Select a patient or add a new one File Patients 3 Select Start test from Test menu ID code IUT E
66. average interval 100 PA dr en a me re repair 100 Sub maximal Exercise Testing 103 Introduction ss sssssessssessessseosossesossesocssecossesocsesesossesocseece 104 Pre test Screening eek seen 104 Sub maximal exercise testing 105 Considerations with sub maximal exercise testing 105 S latin 8 Ac ns nem AE 106 Test termination ceensseenseeeseensnennnennneenneennennnennenne nn 106 Considerations for accur cy esssssessnsenssnunnsnnensnsnennnsensnsnsensnsunsssnen 107 Performing the test iesiccdsccscssiccsssccisecocsecscsessedoccscacsceessceneseosecsseeess 108 An example of testing protocol 108 8 K4 b User Manual Spirometry 109 Setting spirometry OPTIONS cccsccssccssccssccssccssccssccssccosscoescoesees 110 SPOME Y ciate ean Gh padi fede Bois neue ant 110 Automatic Interpretation 110 Quality control 110 Parameters manager uenseesssseessneeennensnnennnneennnennnnennnen 111 Predicted values manager 111 Predicteds setar 2 uu0e siehe ne 111 Set the current predicted u nennen 112 Formula definition 112 Page setup sr ee nie an 113 Spirometry teStS eossosecsecsessccseocsecsesseosessesseosessecsecsssseosesssssesseose 114 Forced Vital Capacity pre cccccccsscssscssscsssccssccsssccsscssscssscoess 115 Recommendations nenn enenne nen 115 Perform a FVC pre test 115 Test encouragement ccenseessssee
67. 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 information 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 ke
68. box and press OK Type the name and the format of the file in the dialog Save as If the ASCII format 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 123 124 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
69. calibration This is necessary to avoid a small leakage in the sure the Reference values connections can discharge the bottle in few time l Make sure you wait for warm up time before starting calibrating Be sure the high pressure tube supplied together with the system is connected to the Cylinder plug Open the cylinder valve by turning the valve counter clockwise the pressure value must be set within a range of 300 500 Kpa 3 5 bars or 44 73 Psi Output Pressure from cylinder must be set between 3 and 5 bars vik I z N Recommended gas mixture gt O2 Oxygen 16 CO2 Carbon monoxide 5 N2 Nitrogen Balance After these operation please operate as follows Reference gas calibration using the PC software 1 3 Connect the K4 b unit to the PC by the serial port Remove the sampling plug from the optoelectronic reader Run the calibration program and choose Gas from the Calibration menu 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 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 The dialogue box showing the calibration results will appear press OK to confirm the calibration Reference gas calibrat
70. ce 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 r Cylinders x100 r Environment x100 02 1604 02 2093 co2 502 c02 E Syringe nl Ce 3000 Volume 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 AAA 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 minutes warm 20 95 O and 0 03 for CO2 You can run this procedure either with the software or up time before starting the di 1 ith the P ble Uni calibration procedure irectly with the Portable Unit Room air calibration using the PC software AAA 1 Connect the Portable Unit to the PC by the serial port Remove the sampling plug Important During from the flowmeter calibration always remove the sampling tube from the 2 Run the calibration
71. ced by time of day eating smoking and familiarization with test procedures e Prediction equations for estimating VO 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 repeat 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
72. chnical 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 Chapter 13 Appendix 139 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 supply the service How your personal data are treated Your personal data will be stored in electronic format and protected at the best from destruction loss even accidental not authorized accesses not allowed treatment or use not in conformity w
73. d pose no safety risk to the patient 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 Cleaning and disinfection AAA Warning Do not use alcoholic solutions for the turbine otherwise there can be damages to the plastic material 132 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 and adapted for COSMED products 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 Disinfecting should ideally be performed by heat sterilisation but gas or liquid sterilisation 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
74. d 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 4 The message Insert relative humidity will be visualized type the correct value and press Enter Insert relative humidity HR xx 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 77 C02 0 4 5 6 Connect the sampling 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
75. 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 77 Viewing predicted values 9 NORMS 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 Choose Predicted from the View menu tn 1 Predicteds L a x Wal 3 Max Hax P Pre E t hh mm 55 00 14 13 Load Watt 450 Real Load Watt ahs BER DE Revolution RPM ook ener vo2 Wass ml min 3534 vo2 Kg Wass ml min Kg m 46 50 VE L min ne 139 0 Rf b min 34 2 VTU 4 48 Ri 1 82 VO2 HR ml bpm er ZUR VE O2 57 VE VCOZ es 35 P Sist mmHg P Diast mmg T nmg doce HR max bpm aoe SE 153 HRR bpm 28 BR 22 27 REE keal day ang en VO2BLT ml min od vo2 Jones ml min 3534 vo2 Kg Jones ml min Kg _ 46 50 Anaerobic Lactate Threshold detection AAA Note Double click in the window to open the corresponding dialog box 78 K4 b User Manual The software allows to detect the Lactate Threshold Anaerobic Threshold according to
76. download time 00 00 09 Preview First Erey oug Next Last r Link to Progr 5 m ie ID code default L Last name GPS Find ID code Close First name TEST 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 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 Ha Gu Receiving test Chapter 6 Database Management 65 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 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
77. ed 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 The 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 HCOSMED Kak Bet 6 Marker key Display Cancel key Enter key Scroll up down key On Off switch 7AmMoaw gt Connections Temperature amp HR probe 6V Power Cable Chapter 3 Installation 33 AAA Warm up Important In order fo ensure The K4 b uses O and CO heated sensors We strongly recommend at least 45 minutes accurate gas measurements you must wait for a warming up Warm up time at an ambient temperature of 20 C More time is necessary if the time before operating the K4 environmental temperature is lower Calibration or testing before warm up time is b During this period the PU completed can cause wrong results must be turned on for at least 45 minutes gt Warming up the unit by main power AAA 1 Connect the Charger Unit to the main power by the AC power cable Warning Supply K4 b with 2 Connect the power supply cable both in the Charger Unit and K4 b as shown sit ger Unit for warming up below and turn both the units
78. ed 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 93 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 American 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
79. en 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 BEE IE Find a visit in the archive Chapter 6 Database Management 67 Enter a new visit card in the archive 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 Delete current test from the archive Edit the current test Import export a Tests card Diagnosis Database 68 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 proprietary 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 Databa
80. erly 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 Search for Find Last name BEE New CID code Progressive Kind List Cancel r Patient Progr 5 ID code 3 _Previous Last name GAS ECG First name INCREMENTAL Modify Sex M Delete OK Ya 2 Select a patient from the list or press New to enter a new name and press OK to confirm Chapter 5 Operating modes 61 62 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 Mode i wn 1 80 0 Height cm 180 0 G Gas Weight Kg 180 0 ECG f Gas ECG Rest ECG I Telemetry Protocol no one bd Other data Ls Le Workspace User 1 Cancel Lover ta RS Beni 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 inse
81. essing Enter Do not breath 02 20 7 CO2 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 C02 0 0 Reference gas calibration AAA The software allows to automatically calibrate zero gain and alignments of the gases Notice Do not use mixtures sensors Even if the program doesn t force you to carry out the calibration the system with a O concentration above should be calibrated before each test To perform the sensor calibration is necessary to 24 since it is out ofthe oxygen sensor range Chapter 4 Calibration 45 AAA of room air and reference gas are properly entered AAA Caution Be sure that the cylinder pressure out is regulated to 3 and 5 bar AAA 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 AAA Notice Before calibrating be sure the Reference values of room air and reference gas are properly entered 46 K4 b User Manual have available a cylinder filled of a concentration known of mixed gas It is suggested to use CO 5 00 O 16 concentrations and N for balance The calibration unit The gas regulator has an adjustable second stage that must be open every time the Notice Before calibrating be Cylinder is used for the
82. etry 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 PC through the RS232 serial port and all tasks exactly like any conventional laboratory device Anyway tests are stored on the me
83. f 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 zdzizt r Available fields b date of birth Zi ID d date of test Zl last name Z first name s sex In the 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 113 Spirometry tests AAA Note Read carefully the contraindications in Chapter 1 114 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 ey 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
84. fferent positions Assemble the mask and the flowmeter AAA Notice In order to preserve items composing the mask it s recommended to grease periodically O rings in the optoelectronic reader with Silicone compound grease 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 CE eir Sampling plug Using the Ultimate Seal 36 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 AAA 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 and
85. 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 SealTM 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 SealTM 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 wind i U Chapter 3 Installation 37 Fixing the K4 b to the patient AAA 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 must be done
86. for avoiding interferences between cables AAA Notice Fix all cables with the velcro strips provided with the equipment 38 K4 b User Manual l 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 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 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 soft
87. h that allows to change the voltage Warning Before turning the y 8 p 8 8 Battery Charger Unit on check according to the following values the voltage switch selected 115V 50 60 Hz 100V 120V meets your main voltage e 220V 50 60 Hz 200V 240V 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 LED charging indicators 32 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 suppli
88. han 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 Chapter 5 Operating modes 57 Telemetry Data Transmission Mode In case you need to monitor in real time the test you can use the Telemetry Data Transmission module that is provided by COSMED as an option The transmission range can reach 800 m allowing to monitor exercise testing in the field To use this option you need a personal computer to connect the receiver unit Telemetry Data Transmission Mode Part List 1 Mask flowmeter 2 Heart Rate belt 3 Battery Antenna 4 Harness 5 K4 b unit 6 HR probe 7 Power amp Antenna cable 8 Telemetric Unit 9 RS232 cable 10 Personal Computer 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 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 sett
89. he software will recompute all the parameters Both the tables and the graphs will be automatically updated Edit Test Phase Time ni Te IV vr O2exp Pie j Ci Rest 00 00 03 UEZ i oe 121 j C2 am up 00 00 06 Ua 8 ee NE rated te ED ed ote A ga 3 Exercise 00 00 11 A Recovery 00 00 15 JE Marker 10 00 00 19 a PR RE Per Ne NEM 2 ox 00 00 27 Cancel 00 00 30 m Preview 00 00 34 Filtering 00 00 38 b ensure ee eee Delete step 00 00 41 Advanced 00 00 45 Restore 00 00 49 Overwrite Test n 21 Stepn 17230 Duration 00 16 15 aa Data filtering Select Filter Type x Filter 7 C Discard invalid steps Averaging 00 24 4 fi gt j o C Smoothing Points B _ 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 83 84 K4 b User Manual Using the User fields
90. hically 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 parameters and predicted equations trough the Formula Editor tool kit e DDE with Microsoft Excel e Customizing software environments colours printed parameters e Help on line Chapter 1 Getting started 21 Before starting Before operating the K4 b we strongly recommend to check the equipment and register you as a customer Checking the packing contents 2
91. iagnosis 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 past 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 es
92. iew bronchial provocation response Press Alt F3 to stop the acquisition discarding the results na Repeat 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 ofthe 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 120 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 tes
93. iew 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 Threshold e The number of consecutive steps that met the preceding criteria are at least Minimum number of steps Steady State x Minimum n of steps YO2 threshold Cancel VE threshold R threshold TT all 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 89 Printout reports 90 K4 b User Manual The software allows the user to printout data and graphics acc
94. ination 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 138 K4 b User Manual 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 eligible 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
95. indications 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 Predicted value FEV1 less than 1 51 in men and predicted value FEV1 in women less 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 Exercise testing Read carefully the exercise testing chapter 16 K4 b User Manual Environmental condition of use 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 interfere
96. ings 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 58 K4 b User Manual 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 Execute Test x Mode i e ELAI Height cm EM G Gas Weight Kg 80 0 C ECG f Gas ECG Rest ECG T Telemetry Le Protocol Othe dot Workspace User 1 Details Cancel Le 4 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 5 Chose Other Data if you want to insert other important informationon the the you are going to perform Execute Test Other Data
97. ion 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 the end of the 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 Not selected parameters Selected parameters Best FEV Best FYC u D2575 pre Date DFEY1 poss Date time DFEV1 pre ERY DFEV1 pred EVC DFVC pre FEF25 75 DPEF DPEFZpre
98. ion using the Portable Unit 1 2 Remove the sampling plug from the flowmeter In the main menu choose Calibration menu choose Refernce gas calibration and confirm by pressing Enter Do not breath 02 720 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 Calibration done 02 16 0 C02 5 0 Gas delay calibration 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
99. it 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 20 K4 bf User Manual 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 I s to 12 V s 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 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 grap
100. ith 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 140 K4 b User Manual In accordance with art 7 of the 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 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 0x0000 021 m Raw data l 1 Name 0x0002 Ambient temp 0x0003 Internal temp 02 0x0005 Barometric press 2 aoe 0x0006 Analyzers Dres Unit of meas zen DE 0x0007 Battery voltage 0x0009 Heart rate 0x000A Turbine Flow 0x000B Turbine Yolume Y mV BL Gain 1000 Base line mY Gain ins F357 Cancel Gain exp fio00
101. k cA Te Ti VEXT All tests FYC Post I Show description l Show Pre I Show SD M Show Pred E OK 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 parameters 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 x Predicteds set Formula definition Q gt NORMS Description Set current predicteds Name of the predicteds FE Save Knudson 83 Agoa ITS LAM Male fo Copy Mc Barcelona Female jo Delete I Modify predicteds a Import Export Cancel Anw 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
102. ke a deeper breath Blow out faster That was a good test FVC reproducible FEV 1 reproducible PEF reproducible MVV time too short Criterion VEXT gt 5 of the 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 Chapter 13 Appendix 145 References 146 K4 b User Manual Gas Exchange References On line computer analysis and breath by breath graphical display of exercise function tests Beaver Wasserman Whipp JAP 34 1 128 132 1973 Measurement and analysis of gas exchange during exercise using a programmable calculator Sue Hansen Blais 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 Bas
103. lderly 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 105 Staffing Test termination 106 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 SE Se Clearly explain test results to the individual Sub maximal tests should be terminated according to ACSM or 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
104. 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 FEVI Forced Expiratory Volume in 1 second FEV1 FVC FEVI as a percentage of FVC PEF Peak Expiratory Flow FEF25 75 Forced mid Expiratory Flow The two representative 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 Ifa 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 Test encouragement 1 D 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
105. mory of the portable unit as well 54 K4 b User Manual Portable Unit User Interface diagram Portable Unit User Interface diagram On Off Restore Factory Enable Disable Units of Warnings Measurement External Device Altitude setting Version Memory functions View test List Start Acquisition Patient s Data Room Air calibration Turbine Set calibr Set calibr calibration Predict Values Factors Calibration Ref Gas O2 CO2 Delay Control Panel GPS control Calibration calibration Chapter 5 Operating modes 55 Holter Data Recorder Mode Operating sequence 56 K4 b User Manual 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 Holter Data Recorder Mode Part List 1 Mask flowmeter 2 Heart Rate belt 3 Rechargeable Battery 4 Harness 5 K4 b unit 6 HR probe 7 Power cable Warming up the system Warm up the K4 b for 45 minutes before testing or calibrating 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 an
106. nces 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 Chapter 1 Getting started 17 Safety and conformity 18 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 IP00 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 33
107. nfirm Chapter 7 Exercise Testing 85 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 1 4b Parameters ml min Formula fams _ _ _ _ ve Cancel Calculator Create a new parameter vuo2 dir 1 Choose Customise parameters from the Options menu YHR 2 Press the New button 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 NN Press the buttons in the calculation group and insert the mathematical formula
108. ng 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 ofthe selected parameter Formula replaces the value of the selected parameter with a mathematical function Time range Specifications From To 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 Customise the display colours 1 Select Colors from Options menu 2 Select the item to be modified 3 Pre
109. ning 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 by4 AA 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 35 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 placed in di
110. nnsennsennsennsennsensnsenssene 32 Battery Charger Unit 32 Check voltage anni gelegene 32 Turn the Unit onana aies at rhin 32 Charge the batteries cccccccesccessceeeceeeceeeeceeeeeeeeeeeeeees 32 Battery low zen ae Rae arm En 33 Portable Unit u ennemi nn nr en en ee 33 Wan UD nn ns mine it times 34 Warming up the unit by main power 34 Turning on off the portable unit e 34 Connect the rechargeable battery 34 REC IVR MIT SSSR an Tnt eas 35 Turning on off the receiver unit 35 Receiver unit power supply ceceeseeteceteceeteenteeeeeees 35 Calibration Gas Cylinder 02rerneesneeenesnneenneeeneenn en 35 Connecting the K4 b to the patient 36 Assemble the mask and the flowmeter nenenene 36 Using the Ultimate Seal 36 Apply the seal to the mask 37 To remove Seal on mask 37 Assembling the flowmeter for spirometry tests 37 Fixing the K4 b to the patient aaaannnnnnnnnenn 38 Index 3 Connecting the K4 b to the PC ssssssssccssssssssssssssccccececeseessscees 39 Connect the Portable Unit to the PC 39 Connect the Receiver Unit to the PC eee eeseeseeeteeeteeenes 39 Software installation rsssssesssssnnnnssssnnnnnessnnsnnsssnnnnnnsnnnnnnnsssnnsnnennne 40 Installing the software 40 R n the software ask feat E 40 PC port configuration 40 Software main features susscssssnnnnnsssnnnnnnssnnnnn
111. nsmission mode only In addition to the Operating sequence of this mode you must carry out the following operation Operating Sequence 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 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 129 130 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 an
112. nssnnnsnnnsnnnnnnnssnnnsnnsnnne 41 Display eines re a ara 41 Tool bar ne Isis Pina 41 Show hide the toolbar 41 Dialog windows us 41 Use of the keyboard 41 Use of the mouse a RE nn lese 41 Scroll Dars rente nn te ne enr 41 On line help 41 Software VerSsiOn 41 Calibration 43 Gas calibration procedures sssssssssseseseseessesessesse 44 Running the Calibration program 44 LOS aI A EAE Re ea eats 44 Setting reference values uueenessseeeneesnneenneenneennee nennen 44 Set the reference values using the PC software 44 Set the reference values using the Portable Unit 45 Room air calibration 45 Room air calibration using the PC software 45 Room air calibration using the Portable Unit 45 Reference gas calibration 45 The calibration unit 46 Reference gas calibration using the PC software 46 Reference gas calibration using the Portable Unit 46 Gas delay calibration 47 Delay calibration using the PC software 47 Delay calibration using the Portable Unit 47 Print the calibration report uenneesneeneenneesneesnnennenneennn en 48 Edit the calibration factors eeeeseeeseeenneeeneeneeeeneeenenennenenn nn 48 Turbine calibration osssssss0ssssssnnnssnsennnnsnnsnnnnsunssssnnn
113. nutes at 121 C 250 F Chapter 12 System maintenance 133 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 Permapure maintenance Inspections Replace the fuses 134 K4 b User Manual e Do not bend squash or deform it e Do not keep it in open air if not used especially in crowded 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 ad
114. ona 144 Reference Adult Paediatric 144 NHANES T 4 2 22 rear ta 144 Reference Adult Paediatric 144 Automatic diagnosis algorithm uenne 145 Quality Control Messages 145 PE D ES EE DORE SE DR EEE TT OT SES LE DEEE DEL EE DE EEE LOT TE NET UE COLE LL 146 Gas Exchange References 146 Indirect calorimetry eeenennennnnnnnen 146 SPILOMELY a ra r ER Pere sr nt ete Re ane tenir 146 Sub maximal testing 146 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
115. ording 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 Reports Configuration xi Report n as C2 aeo Printed pages C4 Test data Parameters M Predicted values M Lactate threshold Test summary M Comments Graphs Print Y1 Axis Y2 Axis X Axis Nil ve toad Fi fe x _More N2W HR vo2 HR It More N3M yo2 vco2 xi It x More Nam More NaF Mor se Wu NZV vr mo graph VE x More N8V fR no graph xil fe x More NIM Pet02 Petco2 l fe x More N10 fpf EM no graph E ft A Fr NIIT fpf E Tino graph ey fe a More NAT fpf EM no graph A za Fi Cancel i 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 depend
116. owmeter even at relatively long intervals i e 1 month The calibration procedure assures valid and verifiable results within a 3 accuracy Assembling the flowmeter for calibration 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 yy Syringe Adapter for calibration syringe Note If a bacterial filter is used for the tests do use it also during the turbine calibration Calibrating the turbine AAA Note If you are using a slow PC we recommend to set an higher refresh time 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 Chapter 4 Calibration 49 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 Syringe volume 3000 mi Results Gain Ins Gain 1046 2993 0 23 1027 1048 2995 0 17 1028 1052 3010 0 33 1026 1052 2993 0 23 1027 1051 2984 0 53 1027 1051 2990 0 33 1028 1051 3004 0 13 1027 1050 300
117. 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 72 K4 b User Manual 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 d
118. program and choose Room air from the Calibration menu 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 be affected 4 The following dialogue box will appear showing the calibration results press OK to confirm the calibration AAA Analyzers Calibration Results x Date 21 01 97 Time from start up 0 06 33 message Calibration done will be visualized Caution During Room Air calibration be sure to put the sampling line far from the expired gas otherwise calibration could be affected Air temperature C Internal temperature C FRE 7 731 Atmospheric pressure mmHg Analyzers pressure mmHg AAA A d s Humidity 2 Caution Room Air calibration performed in small ambients Oxigen Carbon Dioxide high concentration of CO 5 R affects the calibration results eee ite NE and the accuracy of the following test Base line mY 296 Base line mV 526 i Cylinder 15 05 Gain 1023 Gain 1605 Delay ms 673 Delay ms 592 OK Cancel Default Help Room air 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 pr
119. pt 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 performed 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 2 13 OP gt 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
120. rintout header neeee 90 Electronic reports pdf 91 Print the current window 91 Print the customised report 91 Events management during exercise testing ses 92 Flow Volume loops nennen 92 Flow Volume loop during the test cceeeesseesteeetees 92 02 COP VS IMIG 5 eine a lern 92 O2 CO2 vs Time during the test 92 O2 Saturation optional 93 O2 Saturation during the test cecccccseeesseesteetteeneees 93 Spito pra eenei ap nr Eee datent 93 Spirogram during the test 93 View the events after the test 93 Raw dat s etant nant nt rene 93 Save Raw data ss 94 Resting Metabolic Rate Test 95 Metabolism ssssessssersssesossesssssssossesocsesccssesocsecossesocseee 96 Total Metabolic Rate ss 96 Resting Metabolic Rate RMR 96 Importance to measure RMR nnnnneeneseneennen 96 Measure of the rest metabolic rate with indirect calorimetry 96 How to perform a RMR test 96 Recommendations ssrsssssssonsessnnnssnnnnsnnnnsnnnsssnnnsssnnnsnnnnssnnnnsnnnsnne 97 Performing a test sesssscsnsseessssnsnsssssenenesnsaenssesnsntssnnsacssnenssntsrnenseeen 98 Calibrations ss usines Buell a 98 How to prepare a patient 98 Start the tests nes it Mt Re ea nt a a eaaa 98 Viewingitheitest urenteshiseee EE AR E Ai 99 How to modify the
121. rrent patient from the View menu Delete a test 1 Select Patients from the File menu or press 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 121 Printing results You can print out in three different ways e printing the Report e printing the Active Window e printing a series of reports Printing Reports BEE To print a report of the current visit select Print report from File menu The a 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 respon
122. rt other important informationon the the you are going to perform Execute Test Other Data x VO2max mi D UN g day 0 0 FYC 11 0 00 YD ml fo Fa FEY1 1 0 00 BH 2 50 HVV min 0 0 RH fluss 2 100 IC 1 0 00 T fluss C 34 User 1 0 00 Marker User 2 0 00 Distance fo User 3 ooo Un meas D 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 patient data e Edit patient data e Delete patient data Select Patients from the File menu Enter a new patient MM 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 for Find Last name TE
123. rvision 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 Current medications e Activity patterns e Nutritional habits e Reading and signing an informed consent form Sub maximal exercise testing Heart rate varies linearly
124. s 24 K4 b User Manual Code Quantity Description C02150 01 11 C00600 01 11 C02115 01 10 C01278 01 30 C01277 01 30 A 800 900 004 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 Paediatric Headcap ne ee ee ee ee 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 133 MHz e Windows 95 98 XP e 16MbRAM e 3 5 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 25 Technical features Portable Unit Memory Display LCD Keyboard Serial Port Power supply Thermometer Barometer Dimensions P
125. s 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 200ml sec Flowmeter resistance lt 1 5 cmH20 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 FVC The spirometer should be store at least 8 FVC maneuvres FEV1 should be calculated by using the back extrapolation method to detect the start of the test extrapolated volume must not be higher 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 l 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 143 Predicted values ERS93 KNUDSON 83 ITS White race ITS Black race Reference Adult Standardized Lung Function Testing Official Statement of the European Respiratory Society The European Respirator
126. s 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 By nme D Delete New List Find Copy Import Unit of meas ft os 5 r Calculation _ HA Male paediatric Integers r Male adult Decimals r Males limit age E Female adult Females limit age Related to no parameter F7 Export Close Female paediatric 86 K4 b User Manual Exporting data AAA Note The DDE function is available only if the user PC has Microsoft Excel installed F With this function you can export the tests data 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 21x File name Eolders test
127. s for Exercise testing 16 Environmental condition of use ssesssseeseesessesee 17 Safety and CONPOrMity sccccsscccsssccssscccsssccssscccsssccssceccssscosssscsees 18 Dalfety rhin eh E eel rite te dent 18 EMO een initie nine 18 Telemetri nn ter 18 Quality Assurance 18 Medical Device Directive CE mark 18 Keynotes o oo cocccccesctcdesstesosscesedeiuseteccsscesedcdecetesesscetdssscetecsseseccsseessss 19 Typographic keynotes 0 cccccccccsseesseesteesteceteceeceecseeeseeeeeneeees 19 Graphic KeYROTES usure cosleag anregen 19 System overview cciccscciscecscssscesscnsscecdenseceascndacuascedsceascecacuascnssSeasceas eas 20 Portable Unit Pl 08er 20 Telemetry Data Transmission Receiver Unit RU 20 Battery Charger Unit CU 20 FlOWMETEL fc essere keihin ended Ree reat 21 Gras analyse dota esse veces een anni 21 PC SoftWare i hi mnt heaton abies e A na eai 21 Before StOrHiaG sscciiesccdeecescctiscecssdecseeectestecesieecctesceessevevsecetessceeseseuesecs 22 Checking the packing contents 22 K4 b standard packaging enee 22 Warranty registration cccccssccssscsssccssccssccsscsesccesccssccesccesccesooess 23 Register the product via software nennen 23 How to contact COSMED ennnnseenensenssnnennn 23 Complain feedback and suggestions
128. s 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 possible to define the created filename format selecting Options Printout header and then Name format Printed file name Ea eT b date of birth Zi ID 2d date of test Zl last name Zf first name Zn test Zh time of test 4S 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 O
129. se Preview Views a report preview on the screen Printing the active window This printout 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 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 122 K4 b User Manual Export data With this function you can export the test data in 4 different formats txt ASCII xls Microsoft Excel wk1 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
130. se 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 coven 1 r Serial Port Curve n 2 EEE CCOM1 Curve n 3 M COM 2 Curve n 4 i M Concent Unit of meas Cm Kg F Grids FM Show InfoTest C Inch Lbs User Eree 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 the 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 inform
131. 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 ss FYHR xxx VOSPrHH HR IH HH 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 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 Test Download x r Tests to link 2 Test 1 Temperature C 0 ID code 0 Date of test 12 07 01 PB mmHg 740 Sex M Time of test 09 49 Humidity 2 50 Age 25 Duration 00 02 43 Height cm 170 N of steps 71 Weight Kg 70 0 Extimated download time 00
132. set Chapter 10 Spirometry 111 112 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 Delete 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 x Predicteds set Formula definition Q Predicteds set ZEZMNNNNN EEE FA Description Use the predicteds formulae 9
133. ss Change and select the desired colour Smart edit 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 SmartE dit SmartSmooth P ter Parameter Noise no corr max Colt Ti x a3 1 I Value Execute Undo Find Fix Apply the graphical noise suppression Cancel ip 1 Make active a graph or a data window corresponding to the test that you want to modify 2 Press the right key of the mouse and select Smart Edit 3 Select the parameter that you want to modify 4 Point 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 4 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 co
134. ssnenennensnnnnnnnnnenneennnnennen 115 Perform the FVC test with the encouragement 116 Slow Vital Capacity csusesssessnennnennnennnennsennsennsennsennsenssenssennsenssennsens 117 Perform a SVC test 117 Maximum Voluntary Ventilation sssssssssssssesee 118 Perform a MVV test 118 Bronchial Provocation Test 119 Bronchodilator test 119 Methacholine and Histamine Bronchial provocation Tests 119 Perform theitest 2 220802282 anne 120 Bronchial Provocation protocols Database 120 Enter a new Bronchial provocation protocol in the archive share Beeren seieis Ueszeveleoes 120 Viewing results ccccccccsccssccssccssccssccesccesccesccesccssccesccsssccsscoescoes 121 Tests of the current patient s ssnosessoeeeseeesesseeeee seee 121 Delete atest sans enter 121 Printing resulfs ssssssseisscetessescitessecetesescenescenensecetenresteteotsesetene se 122 Printing Reports sie nenn 122 Printing the active window eenssessensnseensennsenenneenennnn nenn 122 To print the active window 122 Printing a series of reports eeeeeeeeeeeeneeenneenneeensennsennne nennen nen 122 Electronic reports pdf ceeccecsceesceeseceeseeeeeeeeeeeeeeteeeneeeses 122 Export data 123 Export AS sce 858er 123 External devices 125 GPS siacccecedesssccsaasccesdeesssessseanccssaerossseseeacesemucesesescessaccgeensessssessescdessee 126 GPS initialisation ss nr rent beads Cebaeeses desta deseidinss 126
135. ssnssnnnnsnnen 49 Assembling the flowmeter for calibration 49 Calibrating the turbine 49 Turbine calibration using the PC software 49 Turbine calibration using the Portable Unit 50 Checking the system signals sssssssssssssssseseesesese 51 The controk panela ennonn nea a a 51 Using the control panel 51 4 K4 b User Manual Operating modes 53 K4 b Operating modes ssssccccsccsssssssssssccccccccccsssssscccecceeessscees 54 Holter Data Recorder 54 Telemetry Data Transmission Option n een 54 Serial Laboratory Station 54 Portable Unit User Interface diagram ss 55 Holter Data Recorder Mode cccccccsccccsccccesccccscccsccccesccccescees 56 Operating Sequence eeecceecceesceeseeteeeeeeeeceecnaecsecnseenseesaeenes 56 Warming up the system 56 Enter new patients idie miraio i 56 Calibrate and start the test 56 StIOptheitestnn anne sera 57 Transferring test to PC 57 Telemetry Data Transmission Mode 58 Operating SeqUEnCe s iriseora sensia insa s ni onni esin 58 Warming up the system 58 Connect the receiver unit to the PC 58 Enable transmission 58 Enter new patient 58 Enable reception on PC ccneensesseenseennneneneenne san 59 Calibrate and start the test 59 Stop the test mine fie el Rien dees ta are 60 Transferring test to PC 60 Serial Mode ussssss
136. ssssnnsesnnnssnnnsnnnnnssnnnssnnnnssnnnnsnnnnssnnnsssnnsnsnnnnssnnne 61 Operating sequence eeeeesceeseeesseeeeeseeeeeceecsecaecnseeeseeeseeees 61 Warming up the system 61 Connect the Portable unit to the PC 61 Calibrate the system 61 Enter patient data 61 Start the test ansehe al 62 Stop the testoni ai ana en o ae ena 62 Database Management 63 Exercise testing patient s database 64 Enter a new patient 64 Find a patient 64 Edit patient data 64 Delete a patient raten lesen 64 Uploading tests from the Portable Unit 65 Archive maintenance ssssssnssssonssssnnnsnnnnssnnnnsnnnnssnnnsssnnnssnsnnnssnnsene 66 Reorganise the archive 66 Delete the archives in rnnnienetin Ans nent 66 Delete testament ae aan TEs 66 Backup and restore 66 Baker nn re mein 66 Restore ie mane time en res 66 Index 5 Spirometry patient s database ssssssssssesessesesesee 67 Patient Card 22 28 Gan sees 67 Visit G rd sense 67 Test Card arten seen ent 68 Import export a Tests card uuuuuneeeeneeeneeeneeennesneeennenennen nn 68 Diagnosis Database cccccccsceesseestecetecsteceecesecneeseeeeneeeeneeses 68 Spirometry program SETHINGS cccscccssccsssccsscrssccesccesccsscssscosscoes 69 Graphs 2 2 2 32 an een ee 69 Serial polt ante deaa a e a N 69 Units of
137. 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 bearing 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 e
138. t fully manually 3 Performing the Post tests Enter a new Bronchial provocation protocol in the archive 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 u 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 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 cu
139. ta in table form uuneenneesseenseennneenneenneennnennn een 76 Creating graphs ae ne ann mister tee 76 View data in graph form 76 Customise the graphs nenn 77 Switch from graph to data and vice versa 77 Viewing predicted values 78 View predicted values 78 6 K4 b User Manual Anaerobic Lactate Threshold detection 78 View the Lactate Threshold 78 Detect the Lactate Threshold 78 Customise graphs for the LT viewing 78 ELA LE D ab ean nassen nahe 79 Fit a graph with a linear regression 79 Fit a graph with a Mono exponential regression 79 Calculate the Mean Value 80 Oxygen Kinetic 80 Run the O2 Kinetic function 80 Information about the Test 81 View the Information 81 Modify the information 81 SUMMARY re M nn Ten nr inner le Nr nee een 81 View the summary 81 Print the data ni ee mere es en sn ages onsen one 81 Print the current window eeenennensensnnn 82 Print the Tepot oertein se o ee KE int 82 View the T pOrtie ses nt nenn ale 82 Data Editing s e esesssesscessussnsnnsussnnsnsussenndsudstun enden nenne renden s sse 83 Editing values and input numerical values 83 Dat jfiltering enunenaisn klasse 83 Using the User fields 00020000 nee 84 Deleting Steps ea ar Rue an
140. tablished Chapter 7 Exercise Testing 73 Real time test fo 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 File Test View Events ECG Window Demo gt a 22 START STOP EVENT vHR At this point the software starts showing data on the monitor but without saving them this in order to monitor the patient before starting the test To start storing data press F2 1 AE 2REC ORS HAS Ru 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 74 K4 b User Manual The visualisation features and capabilities of the data and graphs are identical to the ones described in the Data management
141. ted values i e 16 00 for O and 5 00 for CO3 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 EX 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 44 K4 b User Manual Before starting calibrating make sure that the system has been configured correctly by setting the right values of gas concentration of room air i e 20 95 O and 0 03 CO2 of gas mixture contained in the cylinders and the volume of the calibration syringe 1 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 Referen
142. 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 VCO2 ml min Fetoz Fercozis 3991 18 00 18 00 3532 4 16 20 t u 16 20 3193 4 14 404 tt 14 40 2794 12 604 A 12 60 2395 4 10 80 10 80 1996 4 3 00 9 00 1596 7 20 N 7 20 pos 1197 5 401 4 0 5 40 798 3 60 i 3 60 399 1 80 1 80 702 nl nin 0 00 VOZiml min 0 798 1596 2395 3193 3992 0 798 1596 2395 3193 3992 VE VO2 VE VCOZ Parameter Values LT Max Max 53 53 t hh mm ss 00 05 30 00 11 00 50 0 48 t 48 Load Watt 30 450 20 0 acl i as Real Load Watt 0 0 00 sr 1 pa Revolution RPM 0 0 0 0 i VO2 ml min 1217 3032 401 32 92 VO2 Kg ml min Kg 16 01 39 90 40 1 274 ote dt un 27 VCO2 ml min 1060 3991 26 5 at m met 21 VE l min 24 7 1307 18 9 el ie HR bpm 87 152 57 2 iod 10 RC 0 87 1 68 51
143. 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 is 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 of the Room Air calibration the following message appears Analyzers Calibration x a 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 The software helps to maintain a constant rate by means of a beep sound It is not important to maintain the same rate suggested by the system but it is very important to breath constantly
144. tion of 20 of the FEV1 respect the basal value without drug Main parameters are P10 Dose that causes a 10 fall of FEV1 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 119 Perform the test START C STOP 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 NER 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 v
145. to achieve maximum acquisition performance If significant inaccuracy exists in the initial data 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 ofthe 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 of the 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
146. 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 75 Data management As soon as the test has been completed or downloaded all data stored can be retrieved for a complete management Viewing data Data can be viewed in the following formats Table form numeric values of the various parameters columns corresponding to each step rows Graphic form graphical presentation on Y1 Y2 X charts Summary results of the test and statistical analysis of the blocks Predicted predicted values maximum value measured View data in table form 1 Select Data from the View menu SRE 2 Select the test to visualise in the list box and press OK t RE VT VE vou VCO2 VE VO2 VE VCO2 VO2 Kg R FeO2 FeCO2 HR VO2 HR Load FetO2 hh mm ss b min l 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 71 32 0 90 15 86 4 35 61 9 1 0 14 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 0115 61 00 00 10 12 7 0 610 T 250 236 31 32 3 30 0 94 16 94 3 70 67 3 7 0 15 68 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 AAA
147. ty 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 the Forced one FVC The main parameters 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 prompted on the right side of the screen 2 Press F2 and instruct the Patient to breath normally until the message carry out is prompted then ask to perform a Slow Vital Capacity deep inhalation maximal slow expiration and deep inhalation again 3 Press F3 or wait for automatic interruption 5 seconds without flow in order to visualise the V t graph together with the main parameters compared to the predicted values 4 To visualise the V t graph and the main parameters press the follow buttons view Volume Time graph DATA view data of the test 5 Press Alt F3 to stop the acquisition discarding the results 6 Repeat the
148. ulation John L Hankinson John R Odencrantz and Kathleen B Fedan Am J Respir Critr Care Med 1999 159 1798 187 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 Normal Spirometry Obstructive abnormality it may be physiological Obstructive abnormality mild Obstructive abnormality moderate Obstructive abnormality moderately severe Obstructive abnormality severe Obstructive abnormality very severe Restrictive abnormality mild Restrictive abnormality moderate Restrictive abnormality moderately severe Restrictive abnormality severe Restrictive abnormality very severe Criterion FVC and FEV1 FVC gt LLN Pred FEV1 gt 100 Pred FEV1 lt 100 and gt 70 Pred FEV1 lt 70 and gt 60 Pred FEV1 lt 60 and gt 50 Pred FEV1 lt 50 and gt 34 Pred FEV1 lt 34 FVC lt LLN and Pred FVC gt 70 Pred FVC lt 70 and gt 60 Pred FVC lt 60 and gt 50 Pred FVC lt 50 and gt 34 Pred FVC lt 34 Quality Control Messages Reference Spirometry in the Lung Health Study Methods and Quality Control ARRD 1991 143 1215 1223 Message Start faster Blast out harder Avoid coughing Blow out longer Blow out more air Blow out harder Ta
149. ult button in the dialog box Once you press the default button you must run a new calibration before testing 48 K4 b User Manual Turbine calibration The system uses a turbine flowmeter It opposes a very low resistance to flow 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 an 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 fl
150. ware to the proper serial port for the transmission K4 serial plug Em AR PC Serial plug Chapter 3 Installation 39 Software installation The software is made of two programs one for the ergometry and the other one for the spirometry option The two programs share the same archive and use the same program for the system calibration even if they are used for performing completely different tests Installing the software 1 AAA Notice The software is copy protected Install the software from the original disk Run the software PC port configuration 40 K4 b User Manual ID Select Run from Windows Start menu In the Command line box type a install assuming the disk is in drive A Click on OK or press ENTER key The program will load up a dialog box and ask for a directory where to be installed When the installation is over the program will advise you with a message indicating that the installation has been successfully completed click on End Note the directory for the Spiro software must be the same of the K4 b ergo l 2 In the Windows Start menu open the Program Group in which the software was installed Click the K4 b icon 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
151. 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 Suggested disinfection solutions Helipur H Plus Braun Melsungen AG Gigasept FF Schulke amp Mayr GmbH Dismozon pur Bode Chemie GmbH TETA S Fresenius AG CIDEX Johnson amp Johnson Masks cleaning and disinfection AAA Warning Do not use synthetic or petroleum based products for the masks cleaning 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 remove the impurities 2 Rinse the mask with energy in running hot water 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 mi
152. with VO to the point of maximum exertion thus VOzmax 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 regarding testing are necessary to ensure the highest degree of accuracy when using sub maximal exercise testing to estimate VO e Selected workloads are reproducible A steady
153. 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 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 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
154. x VCOZ ml min 3249 3004 2758 2513 2268 2023 1778 1533 1288 1043 797 552 tihh mm ss 00 30 01 57 03 24 04 51 06 19 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 Onthe Customise graph dialog box select options to obtain the wished graph Customize Graphs x IV Autoscale oe From 00 00 15 4 gt To 00 14 45 4 gt 2 Options gt gt A MED O T Ignore 0 F Grid T Points only I Markers V Autoscale IV Autoscale r es Min 628 692 Min 513 853 T No recovery Max 3350 29 Max 4513 84 F Mark points Step 0 0000 Step 0 0000 Option Grid on X Y axes Autoscale Ignore 0 Not interpolated Marker Squared Without recovery Mark points Min Max Step Function show the grid lines in correspondence with x or y axes that make the graph easier for you to analyse data maximum and minimum values of the graph will be measured automatically points with 0 value measured won t be shown make the graph scattered highlight with a symbol all steps of the test in which the marker button was pressed makes the graph a square exclude from the graph all points of the recovery phase marks each point with a symbol allows to set manually the axes values Set the axes scale step Switch from graph to
155. y Journal Volume 6 Supplement 16 March 1993 Reference Paediatric 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 Adult Paediatric 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 Note SD FEV1 FVC e FEV1 VC da ERS93 Reference Adult Paediatric Intermountain Thoracic Society Clinical Pulmonary Function Testing second edition 1984 pp 101 144 Note SD FEV1 FVC e FEV1 VC da ERS93 Reference Adult Paediatric Intermountain Thoracic Society Clinical Pulmonary Function Testing second edition 1984 pp 101 144 Note SD FEV1 FVC e FEV1 VC da ERS93 Reference Adult Paediatric 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 Note SD FEV1 FVC e FEV1 VC da ERS93 Multic ntrico de Barcelona NHANES III 144 K4 b User Manual Reference Adult Paediatric Spirometric reference values from a Mediterranean population 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 Reference Adult Paediatric Spirometric reference values from a sample of the general US pop
156. y and dependence of pre bronchodilator FEV1 E Dompeling C P van Schayck et Al ERJ 1992 5 975 981 recommend the following parameters 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 bronchodilator Other patients demonstrate spirometric improvement after use of bronchodilator have diurnal variation in peak flows In this groups aerosolised bronchial challenges are used to confirm a diagnosis of Asthma We can summarise the use of the test as follows 1 Diagnose asthma 2 Confirm a diagnosis of asthma 3 Document the severity of 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 reduc
157. y will show latitude and longitude LAT 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 127 128 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 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 Tra

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