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1. Omnia 1 2 Graphs and data shown in this panel are explained here below e On the top left a V T graph showing 30 seconds of subject s breaths After 30 seconds the graph is cleared and it starts graphing from beginning e On the top center the Flow Pbox graph showing the subject s current loop and his her last one The shown loops are not stored These loops are not shown during the SVC or IC tests e On the top right two vertical bars and the correspondent values for respiratory frequency and box pressure updated in real time useful for monitoring these values e On the bottom left the last captured sRaw and the values of all the captured sRaws It is possible to view another sRaw by selecting the corresponding value on the list below the graph e On the bottom center the last captured TGV and the values of all the captured TGVs It is possible to view another TGV by selecting the corresponding value on the list below the graph e On the bottom right the last SVC IC and the values of all the performed SVC IC It is possible to view another SVC IC manoeuvre by selecting the corresponding value on the list below the graph e Onthe very bottom of the screen a status bar that can show informative messages during the test Explain the manoeuvre to the subject prior to testing gt When the subject and the software are ready press Start to perform the trial Select a device
2. BODY PLETYSMOGRAPHY EDIT Techricianac EEE Technician Notes PMouth cmH20 Accepted Trials 2 NormalRange Pred Pred zscore Edit vannzurs Interpretation L cmH20 s lt 12 00 lt 2 24 gt 0 08 gt 0 44 3 11 4 66 TLC Pleth RV Pleth RV TLC Pleth TGV TLC Pleth Raw Tot cmH20 s L Raw ins cmH20 s L Raw exp cmH20 s L 4 76 7 14 6 80 10 20 1 86 2 80 26 38 43 64 The panel is divided into three sections The graphs section is the same as described above in Test editing The QC and notes section is the same as described above in Test editing The results section is divided into two parts e The left side shows a graphical interpretation of the results e The right side the value for each parameter is shown together with the normal range the predicted value the of the value with respect of the predicted and the Z Score if enabled in the Predicted settings In the left side two bars are shown for TLCpleth and for sRaw Near these parameters a colored bar with an indicator representing the current status of the subject The bars also report the normal range Hr Edit Interpretation New Test The buttons in the left part of the panel allows the user to e Edit the test Edit the panel shown under Test editing is displayed e Start a new test New Test The New Test is enabled if the test is performed on the current day e Edit the interpretation Edit Inte
3. 2 19 0 33 4 61 m 4 76 7 14 5 95 6 79 22 7 0 96 4 76 7 14 5 95 0 00 3 93 The panel is divided into three sections The graphs section shows the graph for the best trial both for SVC pre if present and SVC postBD The QC and notes section is the same as described above in Test editing The results section is divided into two parts e The left side shows a graphical interpretation of the results A bar is shown for VC Near this parameter a colored bar with two indicators representing the current status pre and post BD of the subject The bar also reports the normal range e The right side displays data for each parameter The data presented to the user is different depending on the presence of the FVC pre in the current visit 1 If the SVC pre is performed both the SVC pre and the SVCpostBD results are reported For the SVC pre the best value for each parameter is shown together with the normal range the predicted value the of the value with respect to the predicted and the Z Score if enabled in the Predicted settings for the SVCpostBD the best value for each parameter is shown together with the change compared to the SVC pre both absolute and relative the of the predicted value and the Z Score if enabled in the Predicted settings Above the post data the agent and the dose referring to the best step 2 If the SVC pre is not performed the best value for each paramete
4. 60 Volume Li i 5 In this section of the panel all the accepted captures for each accepted trial are shown Each maneuver type is displayed on a different graph Through the mouse it is possible to horizontally move each graph in order to visualize all the captures if some of them are hidden for space reasons QC and notes Techricien oc EEG Technician Notes In this section it is displayed e A quality control entered by the technician e Notes entered by the technician Results cmH20 s cmH20 s L l cmH20 s LicmH20 s cmH20 s cmH20 s L T cmH20 s LicmH20 s L L L L L mL cmH20 L 3 5 TLC Pleth TLC Pleth L RV Pleth The results section is divided into two parts Accepted Trials NormalRange Pred lt 12 00 lt 224 gt 0 08 gt 0 44 3 11 4 66 4 6 7 14 6 80 10 20 1 86 2 80 Pred zscore e The left side shows all the measured parameters for all the performed trials e The right side presents a subset of the parameters For each of them its measured value see below for information about how this value is chosen together with the normal range the predicted value the of the Body Plethysmography Viewing and editing test results 189 value with respect of the predicted and the Z Score Measured values are displayed in italics if they are out of the normal range A scroll bar allows the user to scroll the parameters in order to view all of them
5. Repeat the trials by pressing New until the desired number of manoeuvres has been obtained When New is pressed and the trial is started it is possible to repeat the current step or proceed to one of the next steps it is not possible to go back to a previous steps Caution When you repeat the step the drug must not be administered The drug must be administered ONLY if the selected step is a new one In the Bronchochallenge protocol each step corresponds to one test in the same visit card In each step different trials are stored For example there can be a Bronchochallenge test the 1 step with three trials performed with the diluent then another test the 2n step with one trial performed with 30 mcg of metacholine another one the 3 step with two trials performed with 60 mcg of metacholine etc This means that all the Bronchochallenge trials performed with a defined quantity of drug during a visit i e in the same day are stored under the same test Other trials performed with different quantities of drug are stored under other tests The flow chart at page 160 shows the bronchochallenge test protocol E Test editing ap 4 Edit The test editing panel shows the parameters measured in the trials performed during this step and can be accessed through the Edit button appearing when the near the selected test is pressed or at the end of each trial 154 Spirometry Bronchochallenge BRONCHO CHALLENGE EDIT
6. subject SUBJECT DEMO weight 96 0kg height 195 cm as Accepted Best EXP Best INSP Show Rank FVC FEV1 FEV1 FVC PEF FEF25 75 MEF25 MEF50 MACCTCOL FVC FEV1 FEV1 FVC PEF FEF25 75 MEF25 MEF50 aAcC TCO up etcige e D Barely Passing Technician OC Technician Notes Step 3 Agent Data Metacholine 30 mcg Accepted Trials Normal Range Pred Pred zscore 455 683 3 64 5 47 63 1 94 7 8 11 12 17 3 60 5 40 2 04 3 06 4 49 6 73 TAT INEN 5 69 4 56 The button in the upper left part of the panel allows the user to start a new trial New The Save amp Exit button allows the user to exit the edit panel and saves the results By pressing Save amp Exit the Test results panel will be displayed see below It shows all the protocol steps as a summary and not a single step Warning If the FEV1 falls more than 20 compared to the FVC pre value or to the diluent step if the FVC pre is not present when the Test results panel is displayed a message warns the user that a limit is reached Please end the test as it can become dangerous Fall Step reached Spirometry Bronchochallenge 155 Flow Ls Volume iL Volume L Time s In this section of the panel the F V and V t graphs of the accepted trials are shown together with the graphs of the FVC pre black thin curves The curves are colored according to the results section In t
7. Spirometry Forced Vital Capacity pre 115 subject weight height FVC MEASURE James Bond 79 0 kg 170 cm Flow L Volume L D L Omnia 1 0 The curves are updated in real time Stop When the effort is complete press Stop or wait for the automatic end 5 seconds without flow variation The software will display the F V and V t graphs the parameters and the predicted values For a description of the panel see below Test editing Redo Abort To abort the trial press Abort To restart the trial press Redo Both these commands discard the current trial and don t save any data it is not stored in the archive G New Repeat the trials by pressing New until it the desired number of manoeuvres has been performed Please note that in a single visit there can be only one test per type each of them including all the performed trials This means that all the FVC trials performed during a visit i e in the same day are stored under the same test E Test editing amp Edit The test editing panel shows the parameters measured in the trials performed during this test and can be accessed through the Edit button appearing when the near the selected test is pressed or at the end of each trial 116 Spirometry Forced Vital Capacity pre FVC EDIT Subject gender weight height SUBJECT DEMO Male 98 0 kg 195 cm ps Computer QC Technician OC Technic
8. The value is chosen according to the following criteria e For parameters linked to Raw and TGV a mean of the values in the accepted trials e For VC and TLC the maximum value among all the accepted trials e RV is calculated as TLC VC e For other parameters the values in the trials corresponding to the VC max On the left side for each trial above the measured parameters it appears in order from the top to the bottom e If the trial is accepted By default the software accepts all the trials The user can discard some of them but these trials won t be deleted from the archive also when the user saves and exits from this panel At least 1 trial must be accepted e An Edit button represented by the icon By pressing this button the trial edit panel will open 1 The color of the check boxes can be white __ if selectable blue if deselectable or grey _ if not editable N Select All Near these items on the left two buttons allow the user to e Accept all the trials Select All e Restore the last save Restore E Trial editing The trial edit panel is accessible from the test edit panel it shows the parameters measured in the captures performed during the selected trial and it allows the user to select the captures to be used for the results of the selected trial BODY PLETYSMOGRAPHY TRIAL REVIEW subject SUBJECT DEMO Restore 0 1 cemH20 Flow L s PMouth
9. To add or to delete a role respectively press the Add Role or Delete Role button Press Save to save changes E Event log Event log The event log panel shows all the events logged by the software 60 User interface settings and utilities Utilities EVENT LOG 04 02 2014 11 46 22 AM Success audit 04 02 2014 11 46 18 AM Failed audit 04 02 2014 10 53 49 AM Success audit 04 02 2014 10 48 45 AM Success audit 04 02 2014 10 32 49 AM Success audit 04 02 2014 10 24 19 AM Success audit 04 02 2014 10 20 46 AM Success audit 04 02 2014 10 19 59 AM Success audit 04 02 2014 10 19 59 AM Success audit 04 02 2014 10 19 45 AM Failed audit User cannot login reason User must change password before login Show Severity Failed audit X Success audit Eq It is possible to sort these events by date by clicking on the desired date on the calendar and or by type by checking unchecking the type in the Show Severity section below the calendar To remove the date filter please double click on the selected date The event log can be useful for maintenance activities User interface settings and utilities Utilities 61 Calibration Introduction Regular calibration is necessary to assure your system is acquiring reliable measurements Each device requires different calibrations depending on the features of each product E Flow volume calibration Flow volume calibration is performed using a 3 liter
10. Choice and application of reference values affect interpretation Reference values for TGV using plethysmographically determined lung volumes are not widely available Make a tentative selection from whatever published reference values are available The characteristics of the healthy reference population should match the study group with respect to age body size gender and race The equipment techniques and measurement conditions should be similar Following selection of seemingly appropriate reference values compare measurements obtained from a representative sample of healthy individuals 10 20 subjects over an appropriate age range to the predicted values obtained from the selected reference values If an appreciable number of the sample fall outside of the normal range more appropriate reference values should be sought Body Plethysmography Limitations of the measurement method 187 Viewing and editing test results For Body plethysmography the software allows for three editing levels test edit trial edit and capture edit The test edit panel is shown at the end of each test it shows the parameters measured in the trials performed during the test and it allows the user to select the trials to be used for the final results It can also be accessed through the Edit button appearing when the near the selected test is pressed or at the end of each trial The trial edit panel is accessible from the test edit panel it sh
11. F8 Abort key in test execution F9 Starts the turbine calibration F10 Opens the control panel User interface settings and utilities User interface 35 _ Settings Settings Fam In order to enter in the Settings dialog box press the amp icon in the lower right corner of the screen or the Settings tile on the home panel The Settings dialog box is divided into subsections each of them can be accessed through the list on the left side of the box To confirm the settings press OK or Cancel to cancel the changes All the settings except the logo under Organization details remain if the software is uninstalled and reinstalled E General Q N Settings Confirm upon quitting x Use HL7 compatible Genders jj In this tab you can select e Ifthe software must ask a confirmation when the icon is pressed Confirm upon quitting e If the allowed genders are all the genders included in the HL7 protocol Use HL 7 compatible genders instead of Male and Female HL7 genders are Female Male Transgender Hermaphrodite Undetermined Other 36 User interface settings and utilities Settings E Environment and BTPS Q Pre N Settings Env Temperature Env Pressure mmHg Enw RH Flowmeter Temperat Flowmeter RH Apply Inspiratory BTPS Apply Expiratory BTPS In this tab you can adjust e The environmental temperature Env Temperature pressure Env Pressure and relative hu
12. Body Box calibration Calibration archive The flowmeter calibration archive summarizes for each device the calibrations and the linearity checks performed Calibration Archive To access the archive press Calibration Archive in the Calibration panel CALIBRATION ARCHIVE Select a device Flowmeter Serial 30 01 2014 12 18 PM Body Box Polytropic Factor X9 i i 4 u Be 30 01 2014 12 16 PM Body Box Leakage Check X9 SB i 2 com Cal CO 30 01 2014 12 13 PM x9 tf PA brent Restore Factory Settings 30 Time s Calibration Date 30 01 2014 1 2 13 PM CH4 Analyzer CO Analyzer Analyzers Pressure mmHg Sampling How mL min O Select the device in the top left corner a list of all the performed calibrations and checks will be displayed In this list for each calibration the serial number of the device on which that calibration was performed is shown On the right side the graph and the check data will be displayed if available If you click on the column header of the table on the left side the table is sorted by the respective column Restore Factory Settings To restore the factory settings press the Restore factory settings button The default values for the selected calibration and the selected device are stored replacing the current ones E Printing a report Print Print prints a report with the selected linearity check and the corre
13. Cardiopulmonary Diagnostic Software ge Wo wu lt NA o CAO Q Or S Oo vy wn I W NWI S eo IS N AUT RN mN My S S N y OY 33 e tFo Manuale Utente User Manual Manuel d utilisation Benutzerhandbuch Manual del Usuario COSMED The Metabolic Company nn nn x D a S i N COSMED does not assume any liability for end user interpretation of this user manual or for casual or consequential damages in connection with the provision representation or use of this documentation No parts of this manual may be reproduced or transmitted in any form without the expressed written permission of COSMED Srl Each copy of the COSMED Software can only be installed on one computer Excel is a registered trademark of Microsoft Corporation DBIll is a registered trademark of Bordland International Inc Lotus 123 is a registered trademark of Lotus Development Corporation Omnia Software User manual Ill Edition 01 2014 Copyright 2013 COSMED For SW Release 1 2 COSMED Srl Italy http www cosmed com Part N C04144 02 91 Table of contents TADICTOR Contents errr eerie EN ER Getting started et es r seer cores ene N uence eter err ar nee caer etre rene C Overview of thema a a aa a a a aaa ee 10 El MURR UE HE VO ee nn aaa 11 w TSBOSrapnle ROOTES een ET 11 E Ar NECIO NS ine 11 O Minimum Compute
14. SPIRO PFT Q Box SPIRO PFT Q Box PFT Q Box Recommended interval Each week if the flowmeter is changed if the ambient conditions temperature humidity and pressure change significantly and in all the cases you suspect that the measurements are not reliable anymore Each time the flowmeter is changed the PNT Flowsafe is a disposable device Each day if the flowmeter is changed if the ambient conditions temperature humidity and pressure change significantly and in all the cases you suspect that the measurements are not reliable anymore Each day and before each test Each day Each day or if the ambient conditions temperature humidity and pressure change significantly Calibration Introduction 65 Running the Calibration program Calibration In order to start the calibration program press the Calibration tile in the home panel CALIBRATION En Se i Flowmeters Calibration Flowmeter Verification X9 Linearization Tables gt Gas Calibration Body Box Calibration Calibration Archive Flowmeters Calibration begin a flowmeter calibration Flowmeter Verification begin a flowmeter verification 66 Calibration Running the Calibration program ajf X9 Linearization Tables enter or create the linearization tables for the PNT X9 Gas Calibration begin a gas calibration Body Box Calibration begin a Q Box leakages or polytropic factor check Calibration Archive open the flo
15. Vt EELV EILV E F 3 4 i i 10 20 30 Time s Vt 0680 L IC 461 L OK Cancel e The rank starting from 1 for the best trial The rank is according to the SVC starting from the highest value and decreasing The rank doesn t correspond to the trials sequence e Thecolor representing this trial in the graph above It is not possible to customize the colors 1 The color of the check boxes can be white __ if selectable blue if de selectable or grey _ if not editable Select All Near these items on the left four buttons allow the user to e Accept all the trials Select All e Automatically select the best trial according to ATS criteria ATS which has the maximum SVC value e Accept only the 3 best curves 3 Best according to the three highest SVC values e Restore the last save Restore 148 Spirometry Slow Vital Capacity post Bronchodilator E Test results View To view a test press the View button in the left part of the subject database In this panel data and graphs are not editable by the user Test results can also be accessed by pressing Save amp Exit in the Edit panel bj d igh heigh SVC POST BD RESULTS genuer age weight eight SUBJECT DEMO Male 46 98 0 kg 195 cm 020 es D Barely Passing Technician oc TE Technician Notes Accepted Trials Pre Post Salbutamol NormalRange Pred Pred zscore Meas Change Chang Interpretation a
16. cmH20 aS amp Ge cmH20 6 19 cmH20O s L 1 65 1 cmH20 s 0 16 L cmH20 s 0 60 L L L L L L 5 34 1 42 0 18 0 70 3 57 0 95 0 27 1 04 5 13 1 36 0 19 0 73 6 28 1 67 0 15 0 59 3 95 1 05 0 25 0 94 389 402 385 401 0 148 0 129 0 030 0 029 0 020 TLC Pleth height 195 cm cmH20 s cmH20 s L 1 cmH20 s L cmH20 s L L L L mL cmH20 L L Accepted Trials NormalRange Pred Pred zscore lt 12 00 lt 2 24 gt 0 08 gt 0 44 3 11 4 66 3 88 101 0 04 4 76 7 14 5 95 6 80 10 20 8 50 94 0 68 94 The panel is quite identical to the test edit panel The only difference is that each capture is identified through a color shown above the measured parameters of that capture 190 Body Plethysmography Viewing and editing test results Two observations must be pointed out 1 The calculation of the sRaw and Raw is based on the first accepted TGV capture 2 If a TGV is deselected i e the Accepted checkbox is not checked and an SVC was performed immediately after that TGV also this SVC is deselected If that TGV is selected again the corresponding SVC remains deselected E Capture editing The capture edit panel is accessible from the trial edit panel and it allows the user to edit each single capture sRaw TGV or SVC sRaw editing BODY PLETYSMOGRAPHY TRIAL EDIT P a iey Restore Restore PBox
17. if not editable Select All Near these items on the left four buttons allow the user to e Accept all the trials Add All e Automatically select the best trial according to ATS criteria ATS which has the maximum FVC FEV1 value e Accept only the 3 best curves 3 Best according to the three highest values of FVC FEV1 values e Restore the last save Restore E Test results To view a test press the View button in the left part of the subject database In this panel data and graphs are not editable by the user Test results can also be accessed by pressing Save amp Exit in the Edit panel Spirometry Forced Vital Capacity post Bronchodilator 141 subject height FVC POST BD RESULTS SUBJECT DEMO 195 cm BS 21200 D Barely Passing Technician oc E Technician Notes Accepted Trials Post Salbutam NormalRange Pred Pred zscore Meas Change Char Interpretation FVC 4 55 6 83 5 69 120 1 82 0 04 FEV1 3 64 5 47 4 56 124 2 16 0 10 m wu FEV1 FVC 63 1 94 7 78 9 0 60 0 9 PEF 8 11 12 17 10 14 140 3 38 0 38 FEF25 75 3 60 5 40 4 50 130 1 28 0 33 MEF25 2 04 3 06 2 55 98 0 06 0 25 MEF50 4 49 6 73 124 1 01 A 0 09 MEF75 7 07 10 61 8 84 141 2 10 FEF50 75 FEF25 50 FEF75 85 The panel is divided into three sections The graphs section shows the graph for the best exp and best insp trials both for FVC pre if present and FVC postBD The QC an
18. reversible Bronchodilators can increase airway size by relaxing the smooth muscle This test consists of comparing the results between a reference FVC and the FVC obtained after administering the drug FVC postBD An increase in the FEV1 of 10 12 with respect to the baseline value indicates the presence of reversible airway obstruction The reference FVC is normally an FVC pre an FVC test performed during the same visit The software will allow the user to perform a FVC postBD if aFVC pre is not performed In this case the software uses the predicted value as the reference FVC E Perform a FVC postBD test Testing Spirometry FVC post BD New Test Spirometry FVC post BD Press the Testing tile in the home panel then Spirometry and FVCpostBD or start a new FVCpostBD test from the subject database If no subject was selected in the top part of the panel there is no subject information pressing the Testing tile in the home panel of the software will open the Subject database If no visit card is present for the current day for the selected subject the New visit panel is opened before starting the test A panel will open with the F V and V t graphs 136 Spirometry Forced Vital Capacity post Bronchodilator subject weight height FVCPOST BD MEASURE James Bond 96 0 kg 195 cm pS Volume L Volume L Explain the manoeuvre to the subject prior to testing the same as the FVC pre breathe normally then perform
19. the filename will be composed by lt date of the test gt space line space lt last name gt space lt first name gt This tool is very useful for network archiving data particularly when the central unit requires that the file name is formatted in a specific manner If you click the icon near the path field you can choose the folder in the standard Windows browse dialog box instead of entering it in the box By selecting Open PDF file after exporting the file will be automatically opened after the export is completed User interface settings and utilities Settings 47 E About ON sen N Settings Omnia Cardiopulmonary Diagnostics Suite Version 1 2 5144 26012 Copyright amp COSMED 2013 This software is protected by copyright law Logged in as Administrator Standalone Version SOL Server WOOSMED This tab includes information about the software release and copyright information A link to the COSMED website is also present 48 User interface settings and utilities Settings In order to open the utility tools press the Utility tile on the home panel subject James Bond Broncho Challenge Protocols Ka Device Manager Backup Database weight height d 79 0 kg 170 cm Restore Database PLA Backup Database gt Customize Report User Accounts open the broncho challenge protocol interface backup the database to a backup file User interface settings and utiliti
20. 1505 125 2 187 8 156 5 96 MRF 1 min 38 0 2 pany MVt L 3 96 _ MWt s 11 03 The panel is divided into three sections The graphs section shows the graph for the best trial The QC and notes section is the same as described above in Test editing The results section is divided into two parts 134 Spirometry Maximum Voluntary Ventilation e The left side shows a graphical interpretation of the results e The right side shows the best value for each parameter together with the normal range the predicted value the of the value with respect of the predicted and the Z Score if enabled in the Predicted settings On the left side a bar is shown for MVV Near this parameter a colored bar with an indicator representing the current status of the subject The bar also reports the normal range if available a 2 Edit New Test Interpretation The buttons on the left part of the panel allow the user to e Edit the test Edit the panel shown under Test editing is displayed e Start a new test New Test The New Test is enabled if the test is performed on the current day e Edit the interpretation Edit Interpretation the panel nterpretation of the visit card is displayed e Print a report Print Spirometry Maximum Voluntary Ventilation 135 Forced Vital Capacity post Bronchodilator Bronchodilators are administered during pulmonary function studies to determine if the subject s airflow obstruction is
21. Baa a A E ONE EE ON AN E A A N AAE OAA AA A AA A A A A 193 E Predicted values interpretation susanne EAE rE r Er n Aai 194 E CVC iNe Te ON es 194 Six Minute Walk Test P cesssanesnsnnnsnnnnnnnnsnnnnnnnnnnnnsnnnnssnnnsnsnnnssnnssssnssnsnnnsnnnnnnnn 197 O The Six Minute Walk Test 0 ccsccscsscssccccccccccccceccescescecceccsscsscscnscnsenscncccccaccescascesceccecceccsscssnssnsensenscnscnccescescescess 198 e a EP E E E PAA A NIA A EA A A AE en OA A A O OE 198 E TeSt COA nee ii 198 T Vereine 198 FR SUING E EA EATE E A EE E ee T AAE een 199 CAN UD 1 TANE PENE AEN AIEA PAE AAE TAAA ANE AE A A IAEE A A E EAA T 199 EB EA nee 199 TE een E 200 Getting started Overview of the manual Omnia Software manual consists of the following chapters Getting started is an overview of the manual Installation How to install the software User interface settings and utilities Describes user interface where to access custom settings and software utilities Calibration Outlines all calibration procedures and how to access control panel Database management Description of all database features accessing subject s archive backup Spirometry How to perform spirometry tests FVC etc Lung Diffusing Capacity How to perform DLCO tests Body Plethysmography How to perform body plethysmography tests Raw and TGV Six Minute Walk Test How to view a Six Minute Walk Test 10 Getting started Overview of the manual Impo
22. DEMO 98 0 kg 195 cm pS General Interpretation The subject has a FEV1 VC ratio of 82 3 and a VC value of 6 88 L which are within the normal limits No evidence of a diffusion defect is indicated by a diffusing capacity value of 32 98 mL min mmHg which is within the normal limits Test results indicate a NORMAL PULMONARY FUNCTION Unconfirmed Automatically generated interpretation Generate Confirmed i ina Other Data Q The Interpretation section allows the user to enter an interpretation for the current visit This tab can be completed only when at least one test has been performed and stored for the current visit Generate The interpretation can be entered by the physician by typing the text in the box or automatically entered by the software by pressing the Generate button In this case the interpretation will remain Unconfirmed until the physician confirms it he she evaluate the interpretation as acceptable by clicking in the Confirmed checkbox The unconfirmed status is shown with a statement at the end of the automatic interpretation Note If you already entered a interpretation and press the Generate button the automatic interpretation will overwrite the existing one This section can also be accessed with the Edit interpretation button at the end of a test see in the corresponding chapters describing the test execution Database management Subject database 99 subject gender 2 NEW VISIT SUBJE
23. DLCO VA Near these parameters a colored bar with an indicator representing the current status of the subject The bars also report the normal range br E Edit Interpretation New Test The buttons in the left part of the panel allows the user to e Edit the test Edit the panel shown under Test editing is displayed e Start a new test New Test The New Test is enabled if the test is performed on the current day e Edit the interpretation Edit Interpretation the panel Interpretation of the visit card is displayed e Print a report Print 174 Lung Diffusing Capacity CO Diffusing Capacity DLCO Test Body Plethysmography General warnings Note Please note the contraindications listed in the first chapter of the User manual of the Q Box prior to testing 1 The device must be enabled in the Device Manager it must be properly connected to the PC with the appropriate communication port selected and it must be enabled to perform this kind of test 2 The name shown in the top part of the panel must correspond to the subject performing the test if a subject has not been selected the Subject database will be opened when a test is selected 3 If a visit card doesn t exist for the current testing date the New visit panel will be displayed in order to enter the visit data The test must be performed with the included PNT X9 with the sampling line connected gt 5 The Q Box must be properly connected to
24. EIEE E E AE EE A A EN A E A E A E E E P A E E E 60 El O E A E E 64 E Fow Oe CAA oisi i aa a 64 Turbine calibration N erener S E E 64 PNT Flowsafe calibration PFX SP SPIRO PET Q Box OOR 64 PNT X9 calibration ORO PFT Q 50x Seer 64 E Analyser calibration ICHS ook ccc cccccccccccsccssccscccsccsccssccssessccsscssscsecessesscescesseseessscsseescseecesesescsees 64 E Body Box calibration EEE innen 64 E Talbratoh TETUN G nern 65 O Running the Calibration prograM sssssossesossesossessossesossesossescossssossssossesoosessossssossssossesossseeossssossesossssossssesssssossesosss 66 El Flowmeter cal bration su ana 68 rape echrtchc ompetaies hc EE EST neta REES IE OPELRNEHE VERTERLPRRCREESTINLTERLSTERSEE FERUERLEPROUERUSRILEREOFERUENE PEROERTOFRROEEN 68 Balaton I Sasa ca eee eee i ene eine 69 El flowmeter WE NITICAUION senken 71 O X9 Linearization tables CHP GLUED EIES cc csccssccsccsscsessssssssessessessssssessessessecssessessessesseessessesseasansenees 74 E Import existent linearization tables a anne 74 O Gas calibration HAULEP AAS oo etsesesssssessscsssssssssssssssssssssssssssssossosssssosssssossossossossessosssssessessessossessessessessess 78 PG aii A ats cascada reap sa waa nad ISE daa gages bade NEED AIE E O IE E EI I I NOI as ASE E IE E 78 E Stark Tne calibration pane eridan NENEA 78 MLR G8 ee Ts pe peer ere eee A a ee 79 1 Body Box calibration Wi 82 M LESKAFE TIER einen 83 E PONTOD TICON nennen 84 I e e ARN n
25. Expiratory Flow Parameter Unit of Measurement X ERBE EEE IE OO Be ee Ow S RRARARARRMARAAAAB For each of the report type able to be selected on the drop down menu in the top part of the screen you can select e Which tests will be printed in the report They are selectable in the Tests section This option is not available for all the report types e Which parameters will be printed in the report They are selectable in the Select Rows section The main parameters cannot be deselected e Which fields will be printed for each parameter They are selectable in the Select Columns section h Move Up Move Down You can also select the order of the parameters to be printed by means of the Move Up and Move Down buttons except for the main parameters which will be always printed at the top of the list Note For the Summary report there is a maximum to the number of parameters able to be printed Under the report type selection the available printable parameters for each test type is shown 56 User interface settings and utilities Utilities Press Save to save changes Cancel to discard the changes Restore To restore the factory settings press the Restore button on the left User Accounts User Accounts The User Account tile opens a new panel for changing the password and for the users management subject age weight height USER ACCOUNTS James Bo
26. Modify repair or remove the program Welcome to the COSMED Omnia Setup Maintenance program This program lets you modify the current installation Click one of the options below Select new program features to add or select currently installed features to remove Reinstall all program features installed by the previous setup Remove A Remove all installed features Select Modify if you want to modify the installed features 24 Installation Software installation COSMED Omnia InstallShield Wizard Select Features Select the features setup will install x Select the features you want to install and deselect the features you do not want to install Description 0 00 MB of space required on the C drive 9516 99 MB of space available on the C drive lt Back Next gt Cancel Note By selecting Modify you can also select to initialize the database for example if it is corrupted or if you want to delete all the data in the database or reset the password for example if the password was forgotten Note Initializing the database will delete all the data included in it Select Repair if you want to repair the software files Select Remove if you want to uninstall the software Note The operations described in this section are valid only if the software release in the installation CD is identical to the one already installed If the releases are different please uninstall the old softwa
27. On the top part of the panel as well as on all the other panels the selected subject data and his her anthropometric data are displayed if a subject was already selected from the database see page 94 34 User interface settings and utilities Functioning principles of the software User interface E Dialog windows The typical operating environment of Microsoft Windows is the Dialog box This window includes a series of fields which allows you to enter information Using the keyboard e To move the cursor between fields press the Tab key until you reach the desired field e Press Enter to confirm the information input on the dialog box or press Esc to cancel the changes Using the mouse e To move the cursor among fields move the mouse to the desired field and left click e Left click on OK to confirm the information input in the dialog box or click Cancel to cancel the changes E Scroll bars Some windows have scroll bars that allow you to see data exceeding the window space available e Tomove the scroll bar by row click the arrows at the end of the scroll bars e Tomove the scroll bar by page click the grey area on either side of the scroll field E Shortcuts The following shortcuts are available in the software Esc Returns to the previous screen F1 Opens the software user s manual F2 Returns to the Home panel F5 Start key in test execution F6 Stop key in test execution F7 Redo key in test execution
28. Slow Vital Capacity post Bronchodilator Press OK to confirm and start the trial Cancel to abort Start the trial following the indication in the lower part of the panel breathe normally and then perform the SVC manoeuvre when prompted SVC MEASURE subject age weight height 2 James Bond 59 79 0 kg 170 cm gt 9 E X Start Stop Volume L o L da m n S n S ate a L L 4 0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90 Time s Execute SVC manouevre Omnia 1 9 The curves are updated in real time Stop When the effort is complete press Stop or wait for the automatic end 5 seconds without flow variation The software will display the V t graph the parameters and the predicted values For a description of the panel see Test results and editing below Redo Abort To abort the trial press Abort To restart the trial press Redo Both these commands discard the current trial and don t save any data it is not stored in the archive ak New Repeat the trials by pressing New until the desired number of manoeuvres has been obtained Please note that in a single visit there can be only one test per type each of them including all the performed trials This means that all the SVC trials performed during a visit i e in the same day are stored under the same test E Test editing an t Edit The test editing panel shows the parameters measured in the tri
29. Test is enabled if the test is performed on the current day e Edit the interpretation Edit Interpretation the panel Interpretation of the visit card is displayed e Print a report Print 120 Spirometry Forced Vital Capacity pre Pediatric incentive The above icon displayed during real time FVC testing both pre and post enables disables the paediatric incentive Pediatric incentive is on by default if the subject is 7 years old or less off if the subject is 8 years old or more In either case the incentive can be enabled disabled for all patients by clicking on the above button When on the pediatric incentive shows instead of the classic V t graph the following one FVC MEASU gender age weight height RE James Bond Male 59 79 0 kg 170cm Omnia 1 1 The aim of the animation is to let the fish exit from the fish tank swim in the sea and arrive home In order to exit from the fish tank and to arrive home the subject must reach a target value for both the PEF and the FVC These values are established in the two bars above the animation the first one defines the of the predicted PEF to be reached in order to exit from the fish tank the second one defines the of the predicted FVC to be reached in order to arrive home Spirometry Pediatric incentive 121 _ Slow Vital Capacity pre The Slow Vital Capacity measurement is an important tool in the assessment of COPD Chronic Obstru
30. a subject press the on the left of the patient and then the Edit button The shown panel is the same used for adding a new subject Edit the desired data and press Save to save the data Cancel to cancel the operation Delete a subject x Delete Select a subject press the on the left of the patient and then the Delete button Confirm the action by pressing OK or cancel the operation by pressing Cancel Note All the subject data including visits and tests will be deleted Open the Trend analysis The Trend analysis is available for subject cards containing two or more visits ai Trend Select a subject and press the Trend button in the left part of the panel 96 Database management Subject database Range Selection Start Date End Date subject weight height t SUBJECT DEMO 98 0 kg 195 cm Database Change Parameters Y MMi Change Unit FEV1 FVC Post DB aul Show Hide Data lal Show Hide Lines The Trend panel will open Each graph has a green band which shows for each date the normal range LLN ULN of the most significant parameters of each test On the left six buttons allow to Print print the trend report return to the database panel Change Parameters change the visualized parameters aa Change Unit change the unit measured value of predicted value or the Z score Database management Subject database 97 Show Hide Data show hide
31. and contain the corresponding license FOR STAND ALONE VERSION ONLY When the software is started it checks the license and for this reason the device containing the license must be already connected to the PC unless previously authorized see below If the software find a valid license it will be started and authorized for a 30 days period otherwise a message warns the user and the software will be closed automatically Once authorized the software will remain authorized for a 30 days period During this period it is not necessary to connect the device to the PC prior to starting the software At the end of this 30 day period in order to start the software the device must be connected to the PC again for authorization at this time another 30 day period will begin If the device is re connected before the 30 days period ends another 30 days period starts from that date FOR NETWORK VERSION ONLY If an authorized device is connected to the PC not necessarily when starting the software the operations requiring communication with the device are enabled otherwise only the consultation of the database is allowed If the firmware version of the device is older than the one contained in the software the new firmware is automatically transmitted to the device before opening the software Note The license stored on the device contains the software and firmware versions for which it is authorized Do not attempt to update software and or f
32. and enter the O of the gas used during this trial The membrane diffusion results will be shown in the test edit and results panels only if two or more trials are selected for this test 4 Breath hold method shown only in case of single breath test allows to change the default breath hold method the meaning of each field is explained in the DLCO settings section x ie The buttons in the upper left part of the panel allows the user to e Start anew trial New e Restore the original data ignoring all the editing Restore e Magnify a part of the graph Magnifier A magnifying glass will appear on the graph and it can be moved through the mouse 170 Lung Diffusing Capacity CO Diffusing Capacity DLCO Test The Save amp Exit button allows the user to exit from the trial edit panel saving the results The test edit panel will be shown E Test editing amp Edit The test editing panel shows the parameters measured in the trials performed during this test and can be accessed through the Edit button appearing when the near the selected test is pressed or pressing the Save amp Exit button in the trial edit panel DLCO SINGLE BREATH EDIT subject weight height t SUBJECT DEMO 97 0 kg 195cm Computer QC Breath hold Jones and Meade Technician OC Technician Notes _CH4 CO 3 Volume L Accepted Trials Meas NormalRange Pred Pred zscore mL min mmHg DLCO mL min mmHg 5
33. assigned to an user User interface settings and utilities Utilities 59 Roles management editing reserved to the Administrator only Roles Management The roles management panel allows the Administrator to add roles delete roles or change the rights for each role Other users can only view the information subject gender weight height t ROLES MANAGEMENT SUBJECT DEMO Male 98 0 kg 195 cm 3 Rights Administrator Add Role Calibration perform DB add a subject 2 i DB add and edit a test u DB add and edit a visit Delete Role DB browse subjects DB confirm interpretation DB delete a subject DB delete atest DB delete a visit DB edit a subject DB edit DEMO subject DB edit interpretation Roles add and edit a role Roles delete a role Settings edit organization Users add and edit a user Users delete a user Utility add br protocol Utility backup database Utility delete br protocol Utility edit br protocol Utility restore database Utility view event log nooo0o0o00000000000000000oo g The panel is divided in two sections the roles list on the left and the rights for each role on the right The Administrator and the Technical Support roles are predetermined and cannot be changed For each of the other roles and for the roles defined by the Administrator you can change the rights by selecting or deselecting the corresponding checkboxes on the right section dx Delete Role
34. chosen as the Best The best values are highlighted in the left part of this section with a grey background On the left side above the measured parameters the following appears in order from top to bottom for each trial e If the trial is accepted By default the software accepts all of the trials The user can discard some of them but these trials won t be deleted from the archive when the user saves and exits from this panel At least 1 trial must be accepted e If the trial is the best one This selection is automatically determined using the ATS criteria but the user can select another trial among the accepted ones as the best By changing the selection of the best trial the selected curve is automatically displayed and it cannot be hidden e If the trial is shown in the graph The box can be selected or de selected determining whether the trial will be shown on the graph The Best trial cannot be hidden e An Edit button represented by the icon By pressing this button it is possible to change graphically the EELV end expiratory level and the EILV end inspiratory level of the selected curve which detect the current volume Press OK to confirm changes or Cancel to cancel them The EELV and EILV are represented on the graph with dotted horizontal lines black for EELV and red for EILV The Vt and IC parameters under the graph are automatically updated each time the EELV and EILV values are changed Vi EELV EI
35. current testing date the New visit panel will be displayed in order to enter the visit data 4 If the flowmeter is attached to the breathing valve during the tests please be sure that the corresponding checkbox in the Spirometry settings is enabled 5 The sampling line should be disconnected from the flowmeter for spirometry testing 6 Ifyou are using the turbine either apaper mouthpiece or an antibacterial filter should be connected to the flowmeter prior to executing the tests 7 If you are using the pneumotachograph Flowsafe or X9 do not breathe into the flowmeter until the green led on the lower right part of the screen appears 8 For hygienic reasons the use of an antibacterial filter is strongly recommended When using the PNT X9 the use of an antibacterial filter is mandatory 9 The ID28 turbine the PNT Flowsafe or the PNT X9 should be the flowmeter used during spirometry testing FVC SVC MVV 10 A calibration for the current flowmeter must be recently performed and the linearity check should be performed successfully 11 GCE To avoid potential damage to the items do not hang your hand arm on the breathing valve during the test Note Mobile phones should be turned off prior to testing to eliminate potential interference E Subject preparation Using the turbine Connect the turbine to the unit Disconnect the sampling line from the flowmeter and attach the flowmeter to the handle Calibrate the turbine a
36. dialog box will open showing the subject and the visit data Q Incoming GDT pia Database Subject Hospital ID Subject Hospital ID Insurance Number Insurance Number First Name BOND OB Ethnic Group 04 03 1967 Caucasian Weight kg Height cm 195 The software tries to match the subject data present in the message and in the PC database by ID or by subject data first and last name date of birth and sex If this operation ends successfully the right section will contain the patient s data You can keep this selection or select another subject in archive by typing part of his her identifier in the search field If the software doesn t succeed in matching the subject data no subject is shown and you can select a subject in archive or not By pressing Existing enabled only if a subject in the right section of the dialog box is shown a visit card for the selected subject and for the current day is created if it already exists it will be overwritten Note By pressing Existing the visit card for the selected subject is overwritten if existent while the subject data stored in the PC database are not modified in any case Please note that if some mandatory fields are blank they appear with highlighted red border the message cannot be processed and neither New nor Existing are enabled The GDT file remains in the importing directory and you need to manually delete it or re send the GDT message complete with all
37. drive on this computer To continue type an administrator password and then click Yes mamma Password Show details 4 When the installation is complete the program will confirm that the installation has been successfully completed Running the COSMED_DB_Converter program for importing the archives To start the COSMED_DB_Converter program click on the Windows Start COSMED COSMED_DB_Converter COSMED_DB_Converter Archive Converter File menu and selecting Select the archive to convert Press Select the archive to convert to select which archive you would like to be converted Navigate to the folder containing the Suite Software and press OK Wait for the archive scan Archive Converter E File Archive path C PFTSUITESS10b21_ en 3 Subjects to import 6 Visits bo import 11 Tests to process Convert archive Press Convert archive to initiate the conversion and wait it to process The archive will automatically be imported into the Omnia database 16 Installation Converting existing COSMED database files into OMNIA software Archive Converter Archive has been imported Close the program selecting File Exit Installation Converting existing COSMED database files into OMNIA software 17 Software installation E Introduction Note Before installing a new Omnia release please create a backup of the database The software is provided in two versions Standalone
38. e The software language Language e The unit of measurement Units of measurement for each parameter By clicking on the arrow at the right side of each field it is possible to list all the options for this field Changes will be applied only after restarting the software User interface settings and utilities Settings 43 E Calibration ON sen N Settings Volume Reference Gas Target Pressure cmH20 Target Tau ms Target Polytropic Factor mLicmH20 In this tab you can set e the volume of the calibration syringe used for volume flow calibration in ml Syringe Volume ml e the concentration of the reference gas Reference gas e the target pressure time constant and polytropic factor of the Q Box Body Box 44 User interface settings and utilities Settings PFT Q Box Q PR N Settings Graph Show mouth pressure Single Breath Auto Refresh CO curve when editing Dead Spaces System dead space for X9 VDs System dead space for turbine VDs COSMED Filter dead space VDT Anatomic dead space VDa Use ATS VDa Corrections TLC DLCO for Obstructed Subject i COHb CO Back Pressure Breath hold Time Method Show OC Messages In this tab you can set e if in single breath DLCO tests the mouth pressure signal is presented to the user both in real time and in test viewing Show mouth pressure single breath e if the CO curve during the edit must be updated with the
39. for inspiratory and expiratory flows represents the ranges for low light pink mid light green and high flows light brown When you perform the linearity check it is important to remain as close as possible with one of the bands in order to complete the corresponding check In the right side of the panel you can see for each stroke the measured flow volume and the corresponding relative error and the status of the six checks low mid and high flows for both inspiratory and expiratory flows The color of the icons is red if the corresponding check has not been performed yet or it is not good green if the corresponding check has passed FLOWMETER VERIFICATION Omnia 1 2 The colors of the stroke values are 72 Calibration Flowmeter verification e green if the stroke is accepted both flow and volume in the acceptable range Only the first accepted stroke for each check is green e black if the stroke is accepted but there is another accepted stroke for this flow range or if the flow is not in one of the three low medium or high ranges ered if the volume is outside the ATS range 9 X E Redo Abort Stop During the manoeuvre in order to restart the check press Redo to end the check press Stop to cancel it press Abort V Accept Press Accept to accept the entire check Note The flowmeter linearity check can be stopped even if the six checks are not completed Calibration Flowmeter verificati
40. in a dedicated folder of the main disk for example in C Backup User interface settings and utilities Utilities 53 E Restore database Standalone version only Note In order to perform restore operations the Administrator rights are required Restore Database Restore the database from a previously backed up file Restore From CAOmnia Installers Database_20130319 bak 1 In order to restore a database select a backup file by clicking on the C icon and press Start A progress bar will show the status of the operation E Backup and restore on server PC Network version only In Network version backup and restore cannot be performed by means of the Omnia software It can be performed by the IT department directly operating on the database stored in the server PC E Device manager Device Manager The device manager allows to configure all connected devices 54 User interface settings and utilities Utilities subject gender weight height DEVICE MANAGER SUBJECT DEMO Male 98 0 kg 195 cm pS HK Device Name Enabled Port i Default devices microQuark with dongle OO Scan Devices FVC pre FVC post BD Pony FX Flowsafe with dongle Pony FX Flowsafe Pony FX MIP MEP with dongle Pony FX MIP MEP Spiropalm with dongle Spiropalm Spiropalm 6MWT with dongle Spiropalm 6MWT Spiropalm Plus with dongle Spiropalm Plus FVC post Slow Vital Capacity Slow Vital Capacity post BD Max
41. in order to view all of them The normal range is defined by the LLN ULN range as set in the Predicted settings The Z Score is how many SD s standard deviation the measured value is above or below the predicted value displayed only if enabled in the Predicted settings In the left side for each trial above the measured parameters it appears in order from the top to the bottom e If the trial is accepted By default the software accepts all the trials The user can discard some of them but these trials won t be deleted from the archive also when the user saves and exits from this panel At least 1 trial must be accepted e lf the trial is the best one the one with the maximum value of the DLCO but the user can select another trial as the best one Changing the selection of the best trial the selected curve is automatically displayed e The rank starting from 1 for the best trial The rank is according the DLCO starting from the highest value and decreasing The rank doesn t correspond to the trials sequence 1 The color of the check boxes can be white __ if selectable blue if de selectable or grey _ if not editable pe et ett Select All ATS 3 Best Restore Near these items on the left four buttons allow the user to e Accept all the trials Select All e Automatically select the best trial according to ATS criteria ATS that is the one which has the maximum DLCO value e Accept only the 3 b
42. mandatory data If the GDT message contains also a start test command the corresponding test is started or the generic test selection panel is shown depending on the message content 108 Database management Import data through the GDT protocol When the GDT processing is over the GDT file is deleted if selected in the GDT Settings or renamed in order to be ignored by the software in the future How to process a GDT message 6311 The GDT message shows the results for the subject the visit and the test specified in it The window is the same as the one appearing when you press View in the test section of the Subject database When the GDT processing is over the GDT file is deleted if selected in the GDT Settings or renamed in order to be ignored by the software in the future Database management Import data through the GDT protocol 109 Spirometry General warnings Note Please note the contraindications listed in the first chapter of the User manual of the device prior to testing 1 The device must be enabled in the Device Manager it must be properly connected to the PC with the appropriate communication port selected and it must be enabled to perform this kind of test 2 The name shown in the top part of the panel must correspond to the subject performing the test if a subject has not been selected the Subject database will be opened when a test is selected 3 If a visit card doesn t exist for the
43. mcg Show Rank Accepted Trials NormalRange Pred Pred zscore FWE FEV1 FEVI FVC PEF FEF 25 75 MEF25 MEF50 AACC TOO FVC FEVI FEVI FVC PEF FEF25 75 MEF 25 MEF50 AACC TOO 4 55 6 83 3 64 5 47 63 1 94 7 811 1217 3 60 5 40 2 04 3 06 4 49 6 73 TAFT INEA 5 69 456 78 9 10 14 113 99 89 102 67 41 72 ac The results section is divided into two parts e The left side shows all the measured parameters for all the performed trials e Theright side shows the best value for each parameter together with the change compared to the FVC pre both absolute and relative and the of the predicted value Above the data the step number the agent and the dose referring to the best step If the FVC pre is not present the data is compared to the diluent step If the diluent step is also not present the data is compared to the predicted values and the absolute and relative changes are not displayed Measured values are displayed in italics if they are out of the normal range A scroll bar allows the user to scroll the parameters in order to view all of them The normal range is defined by the LLN ULN range as set in the Predicted settings The Z Score is how many SD s standard deviation the measured value is above or below the predicted value displayed only if enabled in the Predicted settings The best value is chosen according to the following criteria e For main parameters except for
44. not possible to perform the calibration via software for the stand alone devices It must be performed directly on the device N Flowmeters Calibration In the Calibration panel press the Flowmeters calibration tile FLOWMETERS CALIBRATION Omnia 1 2 Begin with the syringe piston pushed all the way in Press the Start button Select a device Quark PFT with dongle If requested select the device Calibration Flowmeter calibration 69 Flowmeter Configuration Select if the breathing valve is used or not Wait until that the red dot in the lower right part of the screen becomes green Move the piston in and out for 6 inspiratory and expiratory strokes FLOWMETERS CALIBRATION Strokes 6 6 Gain Insp 1018 Gain Exp 1029 Before Calibration Volume mL Error After Calibration Volume mL Error Volume L Omnia 1 2 The graph on the left will display the F V graph On the right you will see the current stroke and at the end of the calibration manoeuvre the inspiratory and expiratory gains and the measured volumes with their relative errors both inspiratory and expiratory before and after the calibration During the manoeuvre in order to restart the calibration press Redo to end the calibration press Stop to cancel it press Abort At the end of the calibration press Accept New values will be stored 70 Calibration Flowmeter calibration Fl
45. of the device is necessary In any case the firmware is successfully uploaded Note The Bootloader version is displayed as soon as the device is powered on before the COSMED logo On the right side of the panel you can set the default device among the enabled ones for performing each test type Scan Devices The Scan Devices button will scan all the connected and authorized devices and will update the list on the left accordingly User interface settings and utilities Utilities 55 View The View button allows to visualize the information for the selected device Press Save to save the choices E Customize Report Customize Report The customize report panel allows you to customize the reports printed by the software subject weight height CUSTOMIZE REPORT SUBJECT DEMO 98 0 kg 195 cm BS eeportType Sumay ir Tests Select Rows Select Columns Restore Rows Left Parameter Description Available fields 0 11 Diffusion Lung CO 0 5 DLCO Corrected 0 4 DLCO VA ratio 2 9 Alveolar Volume Total Lung Capacity durin Blood Volume in alveolar Membrane Diffusion Haemoglobin Carboxyhaemoglobin Forced Vital Capacity Forced Exp Volume in 1 s FEV1 as of FVC Peak Expiratory Flow Forced mid expiratory flow Max Exp Flow 75 FVC Max Exp Flow 50 FVC Max Exp Flow 25 FVC Forced Exp Volume in 6 s FEV1 as of FEV6 MIF50 MEF50 ratio Best Forced Vital Capacity Best Forced Exp Volume Best Peak
46. of the panel and press Add To in order to associate the visits of the subject selected in the Device list to the subject selected in the PC list At the end a message confirms the end of the download 106 Database management Receiving data from the unit _ Import data through the GDT protocol Data can be imported in the software through the GDT protocol When a GDT file is placed in the importing GDT directory as defined in GDT Settings see page 39 the software if GDT is enabled in GDT Settings informs the user of this message with the GDT icon in the bottom bar In order to be detected the GDT file must be named as defined in the GDT Settings DATABASE subject age weight height SUBJECT DEMO 46 98 0 kg 195 cm Pi Search by Name or SSN d nn t Subject EL Visits LastName FirstName 008 ender ssw MMM Date Physician Technician Height cm weight tko Type Detail o 98 0 uu DEMO SUBJECT 04 03 1967 Male fi 04 02 2014 195 30 01 2014 Dr House Mr 195 ar 23 01 2014 Dr House Mr 195 29 10 2013 Dr House 2 195 28 03 2013 Dr House Mr 195 New Test If the user clicks the GDT icon or opens the Subject Database a message will appear asking to the user if he she wants to process this message or not In any case the GDT icon will disappear from the bottom bar e If you don t accept to process the message now the software continues working ignoring the GDT message Whenever you open the Su
47. panel and saves the results By pressing Save amp Exit the Test results panel will be displayed see below Summary This section of the panel contains two tabs e the first one Summary contains a summary of the results of the selected trial 198 Six Minute Walk Test The Six Minute Walk Test e the second one Steps Data contains the measured data of the selected trial every 15 seconds If a step is selected the corresponding step on the graphs on the right is highlighted Results The results section shows the measured parameters for all the performed trials A scroll bar allows the user to scroll the parameters in order to view all of them For each trial above the measured parameters it appears in order from the top to the bottom e If the trial is accepted Only one trial can be accepted At least 1 trial must be accepted e lf the trial is the best The trial with the highest distance is automatically selected as the best and the selection cannot be changed e An Edit button represented by the u icon By pressing this button the trial edit panel will open 1 The color of the check boxes can be white __ if selectable blue if de selectable or grey _ if not editable Graphs The two graphs on the right show e the SpO and HR vs time e Ve RF and IC if at least one IC step is selected see below in the trial editing section vs time E Trial editing The trial edit panel is accessible fro
48. report m Copy the selected text if any B Zoom in the report Zoom out the report Ed Set the zoom at 100 Fit the page width to the screen 102 Database management Subject database El View the whole page BE View two pages Database management Subject database 103 Receiving data from the unit LIE Download Tests In order to download the tests performed and stored on the unit please connect the unit to the PC and press the Download Tests tile in the home panel subject gender weight height DOWNLOAD TESTS ps SUBJECT DEMO Male 98 0 kg 195 cm Search by Name or SSN NG J asena Pisanane io OO e View Data 0O Press View data Select a device Pony FX with dongle If requested select the device from which you want to download the tests 104 Database management Receiving data from the unit DOWNLOAD TESTS Search by Name or SSN TEST VALIDATION 00000 P BTPS OFF 00001 View Data BTPS ON 31 00002 BTPS ON 34 00003 BTPS ON 37 00004 RESTRICTION DEFECT 00005 MILD RESTRICTION 00006 NORMAL SPIROMETRY 00007 MIXED DEFECT 00008 OBSTRUCTION DEFECT 00009 MILD COPD 00010 ROCC CHILD 00011 ATS WAVEFORM 00012 In the Device section the subject list stored on the device is shown By clicking on the name or on the arrow sign near it the list of the visits will be shown hidden if any by clicking on the visit or on the arrow near it the list of the tests performed
49. the labels with the measured data show hide the lines connecting the dots The graph shows the sentence No data available to trend this parameter if e No test was performed in this date range e The predicted value is not available in the of the predicted values visualization Visits Add a new visit card New Visit Press the New Visit button in the left part of the panel The New visit panel is divided into three sections subject gender 2 ee SUBJECT DEMO Male General Height cm Weight kg B sa Company saudi Department Mic Occupation Referring Physician iad Physician rechricion LLLULUUUUTUTUTUT UON smoke IE CigDie tbacco Smoking Years SE Spirometry ERS 93 extended DLCO ECCS extended Body Pletysmography ERS93 ECCS Six Minutes Walk Test Troosters Interpretation Other Data The General section is the one shown by default The other sections can be viewed hidden by using the Cy bal icons Enter the required data Mandatory fields are highlighted with a red border In the field Predicted set you can set a predicted set different from the default one selected in Settings see page 41 To calculate the subject height from the arm span press the icon If a subject already has a visit card previously created the fields are pre set with the data stored during the last visit Please change these values if necessary 98 Database management Subject database subject weight height NEW VISIT SUBJECT
50. the pneumotach Note The PNT X9 must be calibrated with the COSMED antibacterial filter E Analyser calibration The software allows you to automatically calibrate the zero gain and delay of the gas sensors We strongly recommend that you perform these calibrations prior to each test Note Before using the device you must allow for the required warm up period which is different depending on which test is being performed The first chapter of the User manual of the device specifies the minimum warm up times The device should be powered on in order to warm up the system It is not necessary that the PC software is open during the warm up period You should not perform calibrations or testing procedures until the system has completed the required warm up period E Body Box calibration The software allows you to verify the box leakage and the polytrophic factor The first operation checks that the global system time constant is within the acceptability range the second one checks that the polytrophic factor is within the acceptability range If one or both these calibrations fail please don t perform any test and contact COSMED technical support 64 Calibration Introduction E Calibration frequency The table below shows a summary with the calibration intervals recommended by COSMED Calibration Turbine PNT Flowsafe DLCO Leakages Polytropic factor Device s PFX Sp SPIRO SPIRO PFT Q Box PFT Q Box
51. the test the AIC calculated as the difference between the baseline IC performed on the Spiropalm before the test and the minimum IC during the test among the selected ICs and the BR Breathing Reserve Near these parameters a colored bar with an indicator representing the current status of the subject The bars also report the normal range The buttons in the left part of the panel allows the user to e Edit the test Edit the panel shown under Test editing is displayed e Print a report Print 200 Six Minute Walk Test The Six Minute Walk Test Wwww cosmed com COSMED srl Via dei Piani di Monte Savello 37 Albano Laziale Rome 00041 ITALY 0 39 06 931 5492 F 39 06 931 4580 COSM ED info cosmed com The MetabolicCompany cosmed com
52. value of the TGV note that the occlusion level cannot be edited In the graph on the right it is possible to change the slope and the intercept of the TGV loop both graphically and using the bars below the graph The value is automatically updated in the corresponding box after each edit The and icons on the graphs allow to respectively zoom in or out the graphs Restore The Restore button near each graph allows the user to discard all the edits performed on the loop Press OK to confirm changes or Cancel to cancel them 192 Body Plethysmography Viewing and editing test results SVC IC editing BODY PLETYSMOGRAPHY TRIAL EDIT The SVC IC edit panel is used to graphically edit the EELV end expiratory level and the EILV end inspiratory level of the selected curve which detect the current volume The EELV and EILV are represented on the graph with dotted horizontal lines The Vt and IC parameters near the graph are automatically updated each time the EELV and EILV values are changed Press OK to confirm changes or Cancel to cancel them mM Test results To view a test press View button in the left part of the subject database In this panel data and graphs are not editable by the user Test results are accessed also by pressing Save amp Exit in the test edit panel Body Plethysmography Viewing and editing test results 193 subject gender weight height SUBJECT DEMO Male 97 0 kg 195 cm
53. volumes according to the Vital Capacity demonstrated by the patient being tested This function may be useful when patients demonstrate a lower than normal VC and have difficulty exhaling the typical collected volume required to obtain measurements E DLCO single breath test procedure 1 Instruct the patient to begin the procedure by breathing normally 2 Ask the patient to exhale completely to Residual Volume ATS ERS standards recommends that this portion of the manoeuvre be limited to 6 seconds In patients with severe obstructive lung disease exhalation to RV may require additional time 3 Next instruct the patient to inhale the DLCO gas mixture to Total Lung Capacity The inspiration should be rapid since the calculations assume instantaneous lung filling ATS and ERS standards state that 85 of the patient s inspiratory volume should be inhaled in less than 4 seconds It should be noted on the post test notes if longer inspiratory times are necessary to achieve the recommended 85 Vi goal 4 When the patient completes a full inspiration instruct him her to hold their breath for the required apnea time Lung Diffusing Capacity CO Diffusing Capacity DLCO Test 163 5 Last the patient should empty their lungs with a smooth unforced exhalation The expired breath should not contain any hesitations or interruptions and the total exhalation time should not exceed 4 seconds It should be noted in the post test notes if the pat
54. zero wet correction Auto refresh CO curve when editing e the system dead spaces for the different items and if the ATS dead space value must be used for the anatomic dead space Dead spaces section e if the TLC DLCO must be corrected for obstructed patients TLC DLCO for Obstructed Subject An obstructed patient is a patient with FEV1 FVC ratio lt 0 70 e which correction method should be applied for carboxyhemoglobin and CO back pressure COHb CO back pressure The COHb corrects the values if the entered COHb value is more than 2 COHb value is entered in the visit card Other data section Additional info e The breath hold time and the method of breath hold Breath hold section e Ifthe Quality Control messages must be shown at the end of the test Show QC messages User interface settings and utilities Settings 45 E Body Box Q Box Q a N Settings General Thermal equilibrium wait time Ventilation valve opening time 5 System dead space mL System Resistance cmH 0 L s Shutter closing timeout Multi sRaw consecutive captures Raw Algorithm Simulated Erlenmeyer Flask Vol 5 58 In this tab you can set the time to be elapsed for reaching thermal equilibrium before starting the test Thermal equilibrium wait time how long the ventilation valve is opened before starting the test in order to reach the pressure equilibrium in a shorter time Ventilation valve opening time the dead space of breat
55. 1 31 30 09 45 14 37 61 3 25 DLCO corr mL min mmHg DLCO corr mL min immHg 51 31 30 09 45 14 37 61 3 25 DLCO VA mL min mmHg L 4 DLCO VA mL min mmHg L 5 71 4 06 6 09 5 07 VA L VA L 8 98 6 28 9 42 7 85 TLC DLCO TLC DLCO L 10 77 6 28 9 42 IV DLCO DM mL min mmHg 56 46 _ Breath Hold Time Ve mL 272 The panel is divided into three sections graphs QC and notes and results The button in the upper left part of the panel allows the user to start a new trial New The Save amp Exit button allows the user to exit the edit panel and saves the results By pressing Save amp Exit the Test results panel will be displayed see below Lung Diffusing Capacity CO Diffusing Capacity DLCO Test 171 Breath hold Jones and Meade Washous Sampling Yolume CcH4 5 CO Se volume L D 2 4 6 2 10 12 14 16 18 a0 Time 5 In this section of the panel DLCO graph of the best trial is shown In the graph the mouth pressure only for DLCO breath hold the breath hold only for DLCO breath hold the washout and the sampling volume are shown QC and notes Computer OC Technician QC f E In this section it is displayed e An automatic quality control by the PC about the trials reproducibility not editable by the user e A quality control entered by the technician e Notes entered by the technician The quality control is graded in 6 levels A excellent B good C satisfactory D barely p
56. 184 Body Plethysmography TGV Raw post Bronchodilator Simulated TGV The simulated TGV test is useful to verify if the TGV measurement meets the accuracy requirements through the Erlenmayer flask standardized method To perform this check please prepare the flask as described in J Wanger et al Standardisation of Lung Volume Measurement Eur Resp J 2005 26 511 522 and reported below Fill a flask of known volume with thermal mass e g copper wool in order to simulate the isothermal conditions within the lung The accuracy of adult plethysmographs in measuring the gas volume of the container should be 50 mL or 3 whichever is greater based on a mean of five determinations Connect the flask to the PNT and close the box door E Test execution Testing Body Plethysmography TGV Simulated New Test Body Plethysmography TGV Simulated Press the Testing tile in the home panel then Body Plethysmography and TGV Simulated or start a new TGV Simulated test from the subject database If no subject was selected in the top part of the panel there is no subject information when pressing the Testing tile in the home panel the software will open the Subject database If no visit card is present for the current day for the selected subject the New visit panel is opened before starting the test A panel will open with some graphs Body Plethysmography Simulated TGV 185 subject gender age weight height t SUBJECT DEMO Ma
57. 9 subject gender weight height t FVC RESULTS SUBJECT DEMO Male 98 0 kg 195 cm Computer OC Technician QC Technician Notes Accepted Trials Normal Range Pred Pred zscore Inte een 4 69 6 69 3 72 5 40 yan FEV1 FVC 67 1 90 7 PEF 8 15 12 13 FEF25 75 2 79 6 21 MEF25 1 27 3 83 MEF50 3 44 7 78 MEF75 6 03 11 65 FEF50 75 FEF25 50 FEF75 85 FEVO 5 The panel is divided into three sections The graphs section shows the graph for the best exp and best insp trials The QC and notes section is the same as described above in Test editing The results section is divided into two parts e The left side shows a graphical interpretation of the results e On the right side the best value for each parameter is shown together with the normal range the predicted value the of the value with respect of the predicted and the Z Score if enabled in the Predicted settings On the left side four bars are shown for FVC FEV1 FEV1 FVC and severity pred FEV1 The last one is highlighted in color only if the subject has an obstruction or a possible restriction Near these parameters a colored bar with an indicator representing the current status of the subject is displayed The bars also report the normal range Edit Interpretation New Test The buttons on the left part of the panel allow the user to e Edit the test Edit the panel shown under Test editing is displayed e Start a new test New Test The New
58. AEE E NE ee N ET 87 BE P a nee nesatens cast acneesaiacsa ase senmasie re 87 PEINEDREVEN ae ac ace oem eae anne aed naan aN ET 88 E EEO 0 ANG copscunesotg NEE EEE EEE ERTEUNLERRERIEERERUHELELUERNENERLCHUEEERUREUELERCEUUEEHETENUEEEEERUEFERLEUHEEERTENUEUEREEONERERTEEULTERUENEEEEREN 89 E Control panel for portable devices f mQ 2 PFX Sp E AE PANIE AEA AAE A A A AAN AN 89 SPIRO PFT E Control panel for Quark series G ECR AS argc ainsi EEE MON E 94 OS aire EN E A E E DEEE conde NE hea EEE E A E EAE NE D A E A AEE E A EENE A E REDEN 95 aala ee W SWS CCE P EEE T EE are 95 Se nes UD E E e AE EEA EA E EA EE 96 Dele ma a a ee een 96 Open the Trend analysis in Sousvalswadadantaoinaternnldwabaceubaaisecdedaaanaraenteiates 96 BB E aE EE EEA O EEE A EEEE E EA EA EAO OEE 98 Aee er VO a Ee EEEE A EEE E ee EE AE EE 98 LEESE ee TREE 100 PSV SU Ce Re E E E 100 PER WAST CANN nee ern 100 EXDOFLINETESIES WLC Pl LOC St ae ne ne 101 Eee a ee RE EEE A a N ER RE 102 STALL I 0 e ce sree qe te ne ea nen re ne A E eegge 102 VIEW ATS ee en ee ee ee ee ee ee ee 102 EA WG SE ee en ee een een 102 DEI OO nen ee ee 102 Printing the results from test VIEWINB u a E a a NE 102 O Receiving data from the unit CESE ce 104 E Download all the subjectsS ssesessecsssecessecsssecscseceesecsosecsesecscsececsececsecesseceeseceesececseceeseceeseceoseseoseceesesecseseeseseeses 105 E Download subjects one Dy one nenne ea 105 LI Import data throug
59. CT DEMO Male General Interpretation Other Reason for visit Symptoms Medical Prescription Data Diabetes i Total Cholesterol mg dL EEE Diastolic Blood Pressure mmHg Eu 178 HDL Cholesterol mg dL Systolic Blood Pressure mmHg a assum No Cardiovascular disease Technician Notes Physician Notes Major CVD Symptoms Details Parameter Exam Date The Other Data section allows the user to enter other data for the current visit i e reason for the visit symptoms prescription clinical data other notes To enter additional info in the corresponding section press the icon under it and fill in the fields Press Save to save the data Cancel to cancel the operation The Save button activates only when the mandatory fields are completed with valid data Edit a visit card F Edit Select a visit press the on the left of the visit and then the Edit button The shown panel is the same used for adding a new visit card Edit the desired data and press Save to save the data Cancel to cancel the operation Delete a visit card Delete Select a visit press the on the left of the visit and then the Delete button Confirm the action by pressing OK or cancel the operation with Cancel Note All the visit data including tests will be deleted Print a visit card Print Select a visit card and press the Print button in the left part of the panel 100 Database management Subject databa
60. FEV1 FVC the maximum value among all the accepted trials e For FEV1 FVC the ratio between the Best FEV1 and the Best FVC e For other parameters the values in the trials chosen as the Best EXP for expiratory parameters and the Best INSP for inspiratory parameters The best values are highlighted in the left part of this section with a grey background On the left side above the measured parameters the following appears in order from top to bottom for each trial e If the trial is accepted By default the software accepts all the trials The user can discard some of them but these trials won t be deleted from the archive when the user saves and exits from this panel At least 1 trial must be accepted e lf the trial is the best one inspiratory and expiratory This selection is automatically determined using the ATS criteria but the user can select another trial as the best portion By changing the selection of the best trial the selected curve is automatically displayed and it cannot be hidden e If the trial is shown in the graph The box can be selected or de selected determining whether the trial will be shown in the graph The Best trials cannot be hidden e Therank starting from 1 for the best trial The rank is according the FVC FEV1 starting from the highest value and decreasing The rank doesn t correspond to the trials sequence e The color representing this trial in the graph above It is not possible to customiz
61. LCO calibration should be performed daily and repeated prior to each DLCO test i gt DLCO Calibration To start a DLCO calibration press DLCO calibration in the Gas calibration panel Calibration Gas calibration 79 DLCO CALIBRATION CH4 gt Cal CH4 CO Cal CO PA mmHg 30 Time 5 Omnia 1 2 Press Start Quark PFT with dongle If requested select the device 80 Calibration Gas calibration DLCO Calibration 1 Verify that the Calibration tank is properly connected to the DLEO inlet in the back of the instrument and make sure the connecting hose is as short as possible if the length of the tubing is higher that 50 cm or 20 inches the first calibration of the day has to be repeated twice 2 Adjust the output pressure of the regulator between 5 and 6 bar 70 90psi and open completely the output valve 3 Verify if the composition reported in the calibration certificate of your tank match the Reference Values specified in the SW program 4 Disconnect the sampling line from the flowmeter and plug it in the calibration valve on the front panel of the unit 5 Press OK to continue 6 Review calibration results against acceptable ranges 7 Plug in again the sampling line into the flowmeter before carrying out a new test Reference Gas 94 Check the warnings and the cylinder gas concentrations in case edit these values according to the cylind
62. LRAEN ARE N EN 43 B 0 BOI ER AA A meses RAD cae edna see 44 teen a a OM aaa 45 E Bony BOX WE iru een 46 Bh OE ee E EEE SE EREEREN SEEN EINREISE NA N D 47 gt 10 0 REN PRPAERICEERSFRESERN FRESEHEUFEL EELOFBECRERNFIENERL FREUE HESTIRPELOEDECRERNFULERLTERIUEHE TER UERLOFDECERENFELVERTSPRIVERESTERUPELFDECEERNFIRVEREFRESRE 48 E OE AAE O EEEN 49 E Broncho Cnalenge Protocol ae 50 Selectan exstent PrOTOCO u een a E EN ana n inde odaamesaseeedess 51 Delete an existent Ol OLOCO au ann 51 PCTS TA WB OC Ola ee ae a een 51 Modiiy an existing DrotOCO l nee eier 53 M Backup database Standalone version only sesesseseseesescsscsesssscsecsescsecseecsecsecssecsecsescsecseecssosesssscsecsescsessescssesees 53 M Restore database Standalone version only ssesssssseseesessessesseoseoseoseoseosecesoeeseeseoseosecseoseosecesoeesesssesesseosecsecssoessee 54 M Backup and restore on server PC Network version only essssesessesssecsesssscseccsecsecsescsecseecssosecssscsecsescsecsescsseesees 54 E Device TONGS nennen 54 OE e RE a a EAE EA O EAO A PA RE AAA A AE E 56 w eor A O aii E tase uiipaanuudenisouamiseoueen 57 BE Aaa Ke ae ee ee ee E ES EA EAE reise 58 Users management editing reserved to the Administrator only ccccccccesseecccceeseecceceeeseceeeeeeeeeceseeeueeeeeeeeees 58 Roles management editing reserved to the Administrator only sessssssssrsssesrresesrrrrsesrrrrresrrrresrrreresrrrrresrerreeses 60 A E ri E EN E ants
63. LV 7 Oo 10 20 30 Time s Vt 0 696 L IC 435 L OK Cancel e The rank starting from 1 for the best trial The rank is according to the SVC starting from the highest value and decreasing The rank doesn t correspond to the trials sequence e Thecolor representing this trial in the graph above It is not possible to customize the colors 1 The color of the check boxes can be white __ if selectable blue if de selectable or grey _ if not editable Near these items on the left four buttons allow the user to e Accept all the trials Select All e Automatically select the best trial according to ATS criteria ATS that has the maximum SVC value e Accept only the 3 best curves 3 Best according to the three highest SVC values e Restore the last save Restore Spirometry Slow Vital Capacity pre 127 E Test results View To view a test press the View button in the left part of the subject database In this panel data and graphs are not editable by the user Test results can also be accessed by pressing Save amp Exit in the Edit panel subject gender age weight height Erp s SVC RESULTS SUBJECT DEMO Male 46 98 0 kg 195 cm BS Computer QC Technician OC in za f u Accepted Trials NormalRange Pred Pred zscore Interpretation a h hh N e o n w n 0 5 03 6 87 5 95 115 The panel is divided into three sections The graphs section shows the gra
64. O measurements obtained from the same patient E Perform a DLCO test single breath standard method Testing DLCO Single Breath New Test Lung Diffusion Capacity DLCO Single Breath Press the Testing tile in the home panel then Lung Diffusion Capacity and DLCO Single Breath or start a new DLCO Single Breath test from the subject database If no subject was selected in the top part of the panel there is no subject information when pressing the Testing tile in the home panel the software will open the Subject database If no visit card is present for the current day for the selected subject the New visit panel is opened before starting the test A panel will open with the V t graph subject gender weight DLCO SINGLE BREATH MEASURE SUBJECT DEMO Male 98 0 kg Volume L Omnia 1 2 Explain the manoeuvre to the subject prior to testing Lung Diffusing Capacity CO Diffusing Capacity DLCO Test 165 gt wis When the subject and the software are ready press Start to perform the trial Select a device Quark PFT with dongle B Aways use it for this test If more than one device was enabled in the device manager a window will appear asking the user to select which device will perform the test Check Always use it for this test if you want to use the selected device every time this test is started Apnoea Duration 5 simulated fj Select the apnoea time 10 seconds is the standard and recommended v
65. Quark PFT with dongle Always use it for this test If more than one device was enabled in the device manager a window will appear asking the user to select which device will perform the test Check A ways use it for this test if you want to use the selected device every time this test is started 180 Body Plethysmography TGV Raw pre Thermal equilibrium phase subject weight BODY PLETYSMOGRAPHY SUBJECT DEMO 98 0 kg gt DX 7 Y TG E GS NG MG x m Redo Zero Volume L L o Volume L L i 45 Sr T T T T T T T T T T T ZA Y T T 0 5 10 15 20 Thermal equilibrium in progress Test starts in 27 seconds Omnia 1 2 an This is the first phase of each test and it is automatically performed before any subsequent manoeuvre sRaw TGV or SVC IC 1 Wait until the end of the thermal equilibrium phase the duration of this phase is defined in the Body Box settings In this first phase the operator is waiting for the thermal equilibrium between the inside and the outside of the Body Box In the meanwhile the patient will begin to relax inside the box and he she can breathe within the PNT in order to familiarize themselves with the device and the technique During this phase all the buttons are disabled and the vent valve between the inside and the outside of the Body Box is open to allow reaching t
66. User Name and ignore the password leaving the field blank Press OK 22 Installation Software installation Please specify a password for login Password Confirm Password A new dialog box will appear the software requires you to enter a password to login To do so enter the selected password and the confirmation on this one Then press OK Warning Please be very careful to store this new password in a safe place Don t forget it If you forget the password perform the password reset according to the instructions in the section Reinstall the software page 24 This reset can be performed only by the system administrator Running the software normally Connect the USB dongle key for devices with a dongle key or an authorized device for devices without a dongle key to the PC Open the Windows Start menu and select COSMED Cosmed Omnia Cosmed Omnia or press the Cosmed Omnia icon on the PC desktop The following panel will automatically opened when the software is started Installation Software installation 23 User Name Password Enter the chosen User Name and the password Press OK Close the software Press the X in the top right corner Confirm by pressing Yes Reinstall the software program maintenance If you start the software installation procedure when the software is already installed the following dialog box will appear _ COSMED Omnia InstallShield Wizard a Welcome zx
67. a maximal inspiration followed by a maximal forced exhalation When the subject and the software are ready press Start to perform the trial Select a device Quark PFT with dongle Always use it for this test If more than one device was enabled in the device manager a window will appear asking the user to select which device will perform the test Check Always use it for this test if you want to use the selected device every time this test is started Wait until that the red dot in the lower right part of the screen becomes green The following dialog box is displayed Agent Salbutamol Unit of Measure ment Enter the agent the unit of measurement if necessary and the dose Administer the agent to the subject Press OK to confirm and start the trial Cancel to abort Spirometry Forced Vital Capacity post Bronchodilator 137 subject weight height FVCPOST BD MEASURE James Bond 79 0 kg 170 cm Flow L Volume L D L Omnia 1 0 The curves are updated in real time Stop When the effort is complete press Stop or wait for the automatic end 5 seconds without flow variation The software will display the F V and V t graphs the parameters and the predicted values For a description of the panel see below Test editing Redo Abort To abort the trial press Abort To restart the trial press Redo Both these commands discard the current trial and d
68. about the trials reproducibility not editable by the user e A quality control entered by the technician e Notes entered by the technician The quality control is graded in 6 levels A excellent B good C satisfactory D barely passing E F failing The PC quality control is graded according the following table Grade Acceptable Manoeuvres n And or other Required Conditions A gt 3 And best 2 FEV1 and FVC matched within 150mL 3 we B gt And best 2 FEV1 and FVC matched within 200mL C gt 2 And best 2 FEV1 and FVC matched within 250mL D 1 Or best 2 FEV1 and FVC did not match within 250mL After the first trial the QC grade can only be D if the manouver is acceptable or F After the second trial the QC grade can become at most C if both manouvers are acceptable and the FEV1 and FVC matches between 250ml Only after the third execution can the QC grade become A or B Results Accepted Best EXP Best INSP Show Rank Accepted Trials NormalRange Pred Pred zscore 4 69 6 69 5 69 120 1 82 3 72 540 456 124 2 16 FEVI FVC 2 67 1 90 7 78 9 105 0 60 PEF FEF25 5 MEF25 MEF50 AACC VOOR PEF FEF25 5 MEF 25 MEF50 AACC TOR The results section is divided into two parts 8 15 12 13 2 79 6 21 1 27 3 83 3 44 7 78 en 11 EC 10 14 e The left side shows all the measured parameters for the trials performed 118 Spirometry Forced Vital Capacity pre 3 38 e On the right side t
69. acceptable and the FEV1 and FVC matches between 250ml Only after the third trial can the QC grade become A or B Results Accepted Best EXF Best INSP Agent Data Salbutamol 400 mcg Accepted Trials Change Change Pred zscore FWE 6 0 04 1 120 1 89 FEV1 2 126 2 36 FEVI FVC PEF FEF25 5 MEF25 MEF50 AACC TOO FEVI FVC PEF FEF25 75 MEF 25 MEF50 AACC TOO 0 9 0 38 0 33 0 25 0 09 The results section is divided into two parts e The left side shows all the measured parameters for all the performed trials 140 Spirometry Forced Vital Capacity post Bronchodilator 1 107 e Theright side shows the best value for each parameter together with the change compared to the FVC pre both absolute and relative and the of the predicted value Above this data the agent and the dose referring to the best step are displayed If the FVC pre is not present the change compared to the FVC pre absolute and relative is not displayed Measured values are displayed in italics if they are out of the normal range A scroll bar allows the user to scroll the parameters in order to view all of them The normal range is defined by the LLN ULN range as set in the Predicted settings see page 41 The best value is chosen according to the following criteria e For main parameters except for FEV1 FVC the maximum value among all the accepted trials e For FEV1 FVC the ratio between the Best FEV1 and the Be
70. actory D barely passing E F failing The PC quality control is graded according the following table Grade Acceptable Manoeuvres n And or other Required Conditions After the first trial the QC grade can only be D if the manouver is acceptable or F After the second trial the QC grade can become at most B if both manouvers are acceptable and the VC matches between 200ml Only after the third trial can the QC grade become A Results Accepted Trials NormalRange Pred 5 03 6 87 5 03 6 87 The results section is divided into two parts e The left side shows all the measured parameters for all the performed trials e The right side shows the best value for each parameter together with the normal range the predicted value the of the value with respect of the predicted and the Z Score Measured values are displayed in italics if they are out of the normal range A scroll bar allows the user to scroll the parameters in order to view all of them 126 Spirometry Slow Vital Capacity pre The normal range is defined by the LLN ULN range as set in the Predicted settings The Z Score is how many SD s standard deviation the measured value is above or below the predicted value displayed only if enabled in the Predicted settings The best value is chosen according to the following criteria e For main parameters the maximum value among all the accepted trials e For other parameters the values in the trials
71. al the selected curve is automatically displayed and cannot be hidden Spirometry Maximum Voluntary Ventilation 133 e If the trial is shown in the graph The box can be selected or de selected determining whether the trial will be shown in the graph The Best trial cannot be hidden e The rank starting from 1 for the best trial The rank is according to the MVV starting from the highest value and decreasing The rank doesn t correspond to the trials sequence e The color representing this trial in the graph above It is not possible to customize the colors 1 The color of the check boxes can be white if selectable blue m if de selectable or grey Jifnot editable Select All Near these items on the left four buttons allow the user to e Accept all the trials Select All e Automatically select the best trial according to ATS criteria ATS which has the highest MVV value e Accept only the 3 best curves 3 Best according to the three highest MVV values e Restore the last save Restore Test results View To view a test press the View button in the left part of the subject database In this panel data and graphs are not editable by the user Test results are accessed also by pressing Save amp Exit in the Edit panel subject age weight height 2 _ xX SUBJECT DEMO 46 97 0 kg 195 cm Techricianoc EEE Technician Notes Meas NormalRange Pred Pred zscore it Interpretation MW L min
72. als performed during this test and can be accessed through the Edit button appearing when the near the selected test is pressed or at the end of each trial Spirometry Slow Vital Capacity post Bronchodilator 145 subject gender weight height t SVC POST BD EDIT SUBJECT DEMO Male 98 0 kg 195 cm tee D E TOT Technician Notes EALAN N ZX DDL ZN IN z I I ST TF I gt 7 Volume a h hh N o n w n 0 Agent Data Salbutamol 400 mcg Accepted Trials Change Change Pred zscore 13 6 1 6 The button in the upper left part of the panel allows the user to start a new trial New The Save amp Exit button allows the user to exit the edit panel and saves the results By pressing Save amp Exit the Test results panel will be displayed see below Graphs Volume L In this section of the panel the V t graph of the accepted trials is shown together with the graphs of the SVC pre black thin curves if performed The curves are colored according to the results section 146 Spirometry Slow Vital Capacity post Bronchodilator QC and notes Technician QC u In this section the following are displayed e An automatic quality control by the PC about the trials reproducibility not editable by the user e A quality control entered by the technician e Notes entered by the technician The quality control is graded in 6 levels A excellent B good C satisfactory D barely
73. alue and if the current trial is a simulated test The simulated test is useful if you wish to conduct a procedure without having the patient inhale CO and CH This function may be useful when familiarizing the patient with the manoeuvre prior to performing the actual test Wait until that the red dot in the lower right part of the screen becomes green Start the trial following the next steps 1 Breathe normally gt ME 2 When the message appears press start during a maximal exhalation 166 Lung Diffusing Capacity CO Diffusing Capacity DLCO Test subject gender weight height DLCO SINGLE BREATH MEASURE SUBJECT DEMO Male 98 0 kg 195 cm CH4 CO Volume L Time 5 Blow Out Omnia 1 2 3 Instruct the patient to inhale the DLCO gas mixture up to a TLC level At the end of inspiration the valve will close and the patient will be forced to hold their breath When the breath hold time is completed instruct the patient to exhale to Residual Volume 4 When the manoeuvre is completed press Stop or wait for the automatic end The software will display the Trial edit panel see below To abort the trial press Abort To restart the trial press Redo Both these commands discard the current trial and don t save any data it is not stored in the archive E DLCO Intra Breath Testing DLCO Intra Breath New Test Lung Diffusion Capacity DLCO Intra Breath Press the Testing tile in
74. and Network The first one can be installed on a single PC the second one in a network Note The installation of the Network version can be performed by the IT department only E General warnings and notes Do not connect the device to the PC before installing the software If you have the Suite software already installed please follow the instructions reported in the section Converting existing COSMED database files into OMNIA software before installing the Omnia Software see the previous section page 15 Stand alone Network Client The software can be installed on Windows Vista 7 8 8 1 32 or 64 bit NOTE It is not compatible with previous versions of Windows Network Server The software can be installed on Windows Server 2008 SP2 Windows Server 2008 R2 SP1 Windows Server 2012 The software requires the firmware on the device to be version 3 0 or higher it is included in the installation CD This firmware is not compatible with old software Suite as well as the old firmware up to 2 99 is not compatible with this software Only the old microQuark model up to S N 2012033999 is compatible with both software versions starting with firmware version 1 3 included It is not possible to install two copies of the software doing so will cause malfunctioning Before installing a new copy of the software please uninstall the previous one see page 24 For devices with a dongle key after installing the Omnia software and after
75. assing E F failing The PC quality control is graded according the following table Grade IV Breath hold DLCO variation Inspiratory time Expiratorytime Sample collection i time s or ml min mmHg s s time s B gt 85 8 12 lt 10 3 ml min mmHg lt 4 lt 4 lt 3 C San 373 D One of the B grade criteria is not satisfied Two different among the B grade criteria are not satisfied F All other cases DLCO Single Breath only 172 Lung Diffusing Capacity CO Diffusing Capacity DLCO Test Results Accepted Best Rank Accepted Trials Meas NormalRange Pred Pred zscore DLCO mL min mmHg DLCO mL min mmHg 51 31 30 09 45 14 37 61 136 335 DLCO corr mL min mmHg DLCO corr mL min mmHg 57 37 30 09 45 14 37 61 136 3 25 DLCO VA mL min mmHg L 4 92 r DLCOWA mL min mmHg L 5 71 4 06 6 09 5 07 112 0 75 VA 3 i VA L 8 98 6 28 9 42 7 85 114 1 80 TLC DLCO I TLC DLCO L 10 77 6 28 9 42 7 85 IV DLCO 6 85 l DM mL min mmHg 56 46 Breath Hold Time Vc mL 272 Uk The results section is divided into two parts e The left side shows all the measured parameters for all the performed trials e The right side the mean value for each parameter is shown together with the normal range the predicted value the of the value with respect of the predicted and the Z Score Measured values are displayed in italics if they are out of the normal range A scroll bar allows the user to scroll the parameters
76. asurement of the diffusing capacity is usually performed by using an inspired gas containing Carbon Monoxide CO because of its high affinity for Hemoglobin approximately 210 greater than its affinity for oxygen Carbon Monoxide is soluble in the blood and has an insignificant concentration in venous blood DLCO measurements may be obtained by the following methods 1 Single Breath with Apnea ATS ERS standard 2 Single Breath without Apnea requires a fast response CO analyzer The main parameters measured during DLCO testing include Symbol UM Parameter DLco ml min mmHg CO Diffusion Capacity DLco corr ml min mmHg CO Diffusion Capacity corrected for Hb COHb PB _ Krogh factor E DLCO single breath standard technique This procedure consists of instructing the patient to carry out a maximal inspiration and an 8 10 second breath hold during which the expiratory valve is closed followed by a slow exhalation to the level of Residual Volume The inhaled mixture contains a low concentration of CO 0 3 and a tracer gas which is not metabolized CH Methane The expired concentrations of CO and the Tracer gas CH are analyzed and the test results are determined ud The wash out volume collected volume and breath hold time must be within a specific range which has been established by ATS and ERS standards You do have the option to customize the optimal range of wash out and collected
77. bject Database the message asking if the GDT message must be processed now will appear e Ifyou accept to process the message now the GDT message is processed Note Since the GDT filename set in the GDT Settings is defined it is necessary to send and process one GDT file at time otherwise the old GDT file will be overwritten by the new GDT file before being processed E Processing the GDT message What the software allows to do with incoming GDT files The software allows only GDT messages asking to e Adda subject and a visit to the archive e Overwrite a subject and a visit in the archive e Adda subject and a visit and start a test only FVC pre SVC MVV DLCO and Q Box e Start atest only FVC pre SVC MVV DLCO and Q Box on an existing subject e View atest result for an existing subject Database management Import data through the GDT protocol 107 The first four activities are managed by the same GDT message type GDT message type 6301 or 6302 while the last activity is managed by the GDT message type 6311 No other GDT message types are compatible with the software See next sections for further details on how the software processes these messages How to process a GDT message 6301 or 6302 The GDT message allows adding or modifying a subject and its visit and it can start a test or not depending on the message data Only FVC pre SVC and MVV tests are supported by the GDT protocol When the processing starts a
78. calibration syringe If the syringe is not included in the packaging it can be ordered directly from COSMED REF C00600 01 11 Each flowmeter requires a separate calibration Note If an anti bacterial filter is used during testing you should also use one when performing the turbine calibration Turbine calibration Flows and volumes are measured by the bidirectional digital turbine which offers a very low resistance to flow Air passing through the helical conveyors cause the spiral rotation of the turbine rotor The rotating blade interrupts the infrared light beamed by the three diodes of the optoelectronic reader The turbine flowmeter does not require daily calibration since it is not affected by pressure humidity and or temperature However regular calibration should still be performed as well as the recommended maintenance procedures see System maintenance chapter of the device user s manual PNT Flowsafe calibration PFX Sp SPIRO PFT Q Box The PNT Flowsafe is a disposable flow transducer pneumotach which calculates the flow by measuring the pressure differential between the two sides of a screen COSMED recommends that you perform a daily calibration and a calibration every time a new box of pneumotachs is opened PNT X9 calibration The PNT X9 is a flow transducer pneumotach which calculates the flow by measuring the pressure differential between the two sides of a screen ATS recommends a daily calibration of
79. cmH20 0 PBox cmH20 Slope l ED 155 N m Intercept Intercept cmH2O s L u 20 s L sRaw Raw l Rawins Raw exp C av Select Loop O Expiratory Inspiratory The sRaw edit panel is divided in two sections the left one allows the editing of the sRaw and Raw the right one allows the editing of inspiratory and expiratory Raw It is possible to change the slope and the intercept of each loop both graphically and using the bars below the graph The values are automatically updated in the corresponding boxes For the right graph before editing it is necessary to select which section of the loop inspiratory or expiratory must be edited The and icons on the graphs allow to respectively zoom in or out the graphs Restore The Restore button near each graph allows the user to discard all the edits performed on the loop Press OK to confirm changes or Cancel to cancel them Body Plethysmography Viewing and editing test results 191 TGV editing BODY PLETYSMOGRAPHY TRIAL EDIT PMouth cmH20 Restore PBox cmH20 C Intercept l The TGV edit panel is divided in two sections the left one allows the editing of the V T curve the right one allows the editing of the slope and intercept of the TGV loop In the graph on the left in particular it is possible to adjust the TGV level the dotted blue line to match the subject s actual TGV value in order to obtain a reliable
80. col Modify an existing protocol In order to modify an existing protocol change the data in the fields and press Save Please see the section above Add a new protocol for a description of each field E Backup database Standalone version only Note In order to perform backup operations the Administrator rights are required Backup Database We recommend that you periodically back up the archives in order to avoid damage or loss of data Data can be backed up on the PC itself or on an external device CD DVD external hard disk If you back up your data on an external device the data is protected against PC crashes and or damage or against internal hard drive crashes or damage On the contrary if data are backed up only on an external device they cannot be protected against damage of that external device COSMED does not assume any liability for damage or loss of data for example if a hard drive a PC a DVD damage should occur We suggest to create multiple back ups of data in order to overcome these potential problems Media damages occur more frequently than you can imagine Destination ChOmnia Installers Database_20130319 bak 1 Enter the path and the name of the backup file by clicking on the C icon and press Start A progress bar will show the operation status Note the backup must be stored in a folder not connected to the current user i e the desktop or the Documents folder We suggest to save the file
81. com en us download details aspx id 30653 for Microsoft Framework 4 5 e http www microsoft com en us download details aspx id 30438 for SQL Server 2008 R2 SP1 Express Additional free space is required if the above mentioned packages must be installed e 850 MB x86 or 2 GB x64 for Microsoft Framework e 512 MB for SQL Server 2008 R2 SP1 Express For devices with a dongle key 2 USB port are highly recommended one for the dongle key the other one for the device 14 Installation Minimum Computer PC Requirements Converting existing COSMED database files into OMNIA software Important note Before installing the Omnia Software please follow the instructions Note Install the COSMED_DB_Converter program only after the Omnia Software installation otherwise it won t work The COSMED Suite Software is the software used with COSMED devices prior to the release of the Omnia Software If your PC has the COSMED Suite Software already installed please follow these instructions in order to upgrade the software to the Omnia Software and to import the old archives into the new software Note Archives can only be converted from Suite Software version 8 0 and higher 1 CZE Connect the device to the PC and download the archives to the Suite Software please refer to the Suite Software user manual 2 Perform a backup of the archives in the Suite Software please refer to the Suite Software user manual 3 Close the S
82. ctive Pulmonary Disease Parameters measured during SVC tests include the following Symbol UM Parameter The first three parameters of the previous list are the main parameters These parameters are not customizable by the user See the Test editing section below for more information E Perform a SVC test Spirometry A New Test Spirometry Press the Testing tile in the home panel then Spirometry and SVC or start a new SVC test from the subject database If no subject was selected in the top part of the panel there is no subject information pressing the Testing tile in the home panel of the software will open the Subject database If no visit card is present for the current day for the selected subject the New visit panel is opened before starting the test A panel will open with the V t graph 122 Spirometry Slow Vital Capacity pre subject age weight height au a nn James Bond 46 96 0 kg 195cm pS Volume L 45 Time s Omnia 1 0 Explain the procedure to the subject prior to beginning the test breathe normally then perform a maximal inspiration followed by a slow maximal exhalation for the EVC or perform a maximal exhalation followed by a slow maximal inspiration for the IVC When the subject and the software are ready press Start to perform the trial Select a device Quark PFT with dongle WM Always use it for this test If more than one device was enabled in th
83. d drive Note The cached files contain the information about the authorized devices Clearing the cached files the 30 day period for this device will be cancelled In order to start the software an authorized device must be connected to the PC again 28 Installation License management z elic Management Device Management Dongle Management Device Selection Get Device Information Selected device microQuark USB Upload Firmware Upgrade Device License In order to update the firmware on the device select the Update Firmware tab and press Upload EM COSMED Licenser x elic Management Device Management Dongle Management Device Selection 2 Selected device microQuark USB Get Device Information Upload Firmware Code 1 Code 2 Upgrade Device License fo 5 E Code 3 fo Code 4 E Code 5 fo Code 6 E In order to update the license on the device please open the Update Device License tab enter the license codes and press Upgrade Alternatively if you already have a file with the license it is possible to load the license from this file by pressing the Load from file button and selecting the proper file The new license will be sent to the device and will be updated accordingly Installation License management 29 User interface settings and utilities Functioning principles of the software The software panels include some central tiles and some icons at the four corners Below the hom
84. d notes section is the same as described above in Test editing The results section is divided into two parts e The left side shows a graphical interpretation of the results Four bars are shown for FVC FEV1 FEV1 FVC and severity pred FEV1 The last one is highlighted in color only if the subject has an obstruction or a possible restriction Near these parameters a colored bar with two indicators representing the current status pre and postBD of the subject The bars also report the normal range e Theright side displays data for each parameter The data presented to the user are different depending on the presence of the FVC pre in the current visit 1 Ifthe FVC pre is performed both the FVC pre and the FVCpostBD results are reported For the FVC pre the best value for each parameter is shown together with the normal range the predicted value the of the value with respect to the predicted and the Z Score if enabled in the Predicted settings for the FVCpostBD the best value for each parameter is shown together with the change compared to the FVC pre both absolute and relative the of the predicted value and the Z Score if enabled in the Predicted settings Above the post data the agent and the dose referring to the best step 2 If the FVC pre is not performed the best value for each parameter is shown together with the normal range the predicted value the of the value with respect of the predicted and the Z Sc
85. during this visit will be shown hidden if any by clicking on the test or on the arrow near it the list of the trials performed during this test will be shown hidden if any You can choose to download all the subjects together or one by one Before downloading the tests it is possible to edit the subject data for each of the subjects in the Device list In order to do that select the subject and edit its data shown in the Update Data section as desired Download all the subjects Press the button Add All If a subject is already present in the PC database a warning message asks the user if the visits of the current subject must be associated to the subject in the PC archive or not At the end a message confirms the end of the download Download subjects one by one Select the subject to download onto the Device list It is not possible to download only a subset of visits or tests performed by a subject but all the visits and tests performed by him her If the subject is not present in the PC archive press Add New in order to create a new subject with the data of the one stored in the device The subject and its visits and tests is now imported in the PC database Database management Receiving data from the unit 105 If the subject is already present in the PC archive type in the field above the PC section the first letters of the subject select the subject in the PC list his her data will be shown in the top part
86. e dongle each time the software is started and before starting it FOR NETWORK VERSION ONLY When the software is opened it checks the license on the dongle if connected to the client PC If the software finds a valid license it will be fully functional otherwise no dongle is connected or the license is not valid only the consultation of the database is allowed So it is mandatory to connect the dongle each time the software is started and before starting it in order to work with the device calibration testing If the firmware version of the device is older than the one contained in the software the new firmware will be automatically transmitted to the device before starting the software Note The dongle is associated to a specific device and S N A dongle doesn t work with a device which is different from the one for which it is assigned to The dongle also contains the software and firmware versions for which it is authorized Do not attempt to update software and or firmware without having a valid license otherwise the software and or the device will become inoperable Note If you change the dongle when the software is running in order to use a different device please close and restart the software in order to acquire the proper license E Devices supplied without a dongle key The devices supplied without a dongle key already arrive authorized by COSMED to operate with the software release included in the packaging
87. e device manager a window will appear asking the user to select which device will perform the test Check Always use it for this test if you want to use the selected device every time this test is started Wait until that the red dot in the lower right part of the screen becomes green Start the trial following the indication in the lower part of the panel breathe normally and then perform the SVC manoeuvre when prompted Spirometry Slow Vital Capacity pre 123 subject weight height SVC MEASURE 2 James Bond 79 0 kg 170 cm Volume L oo Execute SVC manouevre Omnia 1 9 The curves are updated in real time Stop When the effort is complete press Stop or wait for the automatic end 5 seconds without flow variation The software will display the V t graph the parameters and the predicted values For a description of the panel see Test results and editing below Redo Abort To abort the trial press Abort To restart the trial press Redo Both these commands discard the current trial and don t save any data it is not stored in the archive cl New Repeat the trials by pressing New until the desired number of manoeuvres has been obtained Please note that in a single visit there can be only one test per type each of them including all the performed trials This means that all the SVC trials performed during a visit i e in the same day are stored under the same test E Tes
88. e panel is shown Database Calibration gt Settings Download Tests The central tiles lead to the corresponding section of the software On the home panel there are six tiles which allow the user to at Database Open the subject database Start a test Calibration Start the calibration program 32 User interface settings and utilities Functioning principles of the software Open the utility tools Settings Open the Settings window Download Tests Start the test download interface Support Connect to the COSMED support website Note In order to have the Support function working you must have an active Internet connection The Lal and B icons allow you to navigate through the different pages of the panel The other icons have the following meanings Fo a x CHOOT gt Returns to the previous screen Minimize the window Close the software Note this icon doesn t close the current panel it closes the entire software program the user is prompted for a confirmation Return to the home panel Logout user Open the Settings window Open this user manual and the splash screen n USB icon is displayed in the lower right part of the screen when a device is connected to the PC through the USB port User interface settings and utilities Functioning principles of the software 33 subject weight SUBJECT DEMO 98 0 kg Database Calibration gt Settings Download Tests
89. e the Prev Step and Next Step buttons to select the desired step Modify the agent dose if needed Press OK If one or more steps were already performed the proposed step is the last one performed It is possible to repeat it or go to one of the following steps by means of the Next Step button It is not possible to go back to a previous step Caution When you repeat the step the drug must not be administered The drug must be administered ONLY if the selected step is a new one If necessary administer the agent to the subject only if a new step is selected M subject age weight height FVC POST BC MEASURE James Bond 59 79 0 kg 170 cm A Volume L Volume L Omnia 1 0 The curves are updated in real time Spirometry Bronchochallenge 153 Stop When the effort is complete press Stop or wait for the automatic end 5 seconds without flow variation The software will display the F V and V t graphs the parameters and the predicted values For a description of the panel see Test editing below Warning If the FEV1 falls more than 20 compared to the FVC pre value or to the diluent step if the FVC pre is not present please end the test since it can become dangerous Pay attention to this value at the end of each trial D gt X Redo Abort To abort the trial press Abort To restart the trial press Redo Both these commands discard the current trial and don t save any data it is not stored in the archive
90. e the colors 1 The color of the check boxes can be white __ if selectable blue if de selectable or grey _ if not editable Spirometry Bronchochallenge 157 ISS Select All Near these items on the left four buttons allow the user to e Accept all the trials Add All e Automatically select the best trial according to ATS criteria ATS that is the one which has the maximum FVC FEV1 value e Accept only the 3 best curves 3 Best according to the three highest values of FVC FEV1 values e Restore the last save Restore E Test results Note In this section where FVC pre is referred it means that if selected through the Change button see below the diluent step can be used instead of FVC pre step View To view a test press the View button in the left part of the subject database In this panel data and graphs are not able to be edited by the user Test results includes all the steps of the Bronchochallenge test Test results are accessed also by pressing Save amp Exit in the Edit panel subject gender weight height BRONCHO CHALLENGE RESULTS ps SUBJECT DEMO WEI 96 0 kg 195 cm Technician Notes Diluent Diluent Stepl Step2 Step3 Representation PM 12 53PM 12 58PM 1 02 PM tere FEVI baseline Sen een oe B D Change Fall FEV1 FVC Interpretation FEV1 FVC PEF FEF25 75 MEF25 MEF50 MEF75 FEF50 75 dfev of Baseline A N NON Step1 30 mcg St
91. easured during MVV testing include the following Symbol UM Parameter MVV L min Maximum Voluntary Ventilation MRf 1 min Maximum Respiratory frequency Mvt L Tidal Volume during MVV MVVt S MVV duration time The first three parameters of the previous list are the main parameters These parameters are not customizable by the user See the Test editing section below for more information E Perform a MVV test Spirometry New Test Spirometry Press the Testing tile in the home panel then Spirometry and MVV or start a new MVV test from the subject database If no subject was selected in the top part of the panel there is no subject information pressing the Testing tile in the home panel of the software will open the Subject database If no visit card is present for the current day for the selected subject the New visit panel is opened before starting the test A panel will open with the V t graph Spirometry Maximum Voluntary Ventilation 129 subject weight height James Bond 96 0 kg 195cm A Time Is Explain the procedure to the subject prior to beginning the test breathe as deep and fast as possible for 12 seconds When the subject and the software are ready press Start to perform the trial Select a device Quark PFT with dongle WM Always use it for this test If more than one device was enabled in the device manager a window will appear asking the user to select which device will perfor
92. easured parameters for all the performed trials e The right side the best value for each parameter is shown together with the normal range the predicted value the of the value with respect of the predicted and the Z Score Measured values are displayed in italics if they are out of the normal range A scroll bar allows the user to scroll the parameters in order to view all of them The normal range is defined by the LLN ULN range as set in the Predicted settings The Z Score is how many SD s standard deviation the measured value is above or below the predicted value displayed only if enabled in the Predicted settings The best value is chosen according to the following criteria e For main parameters the maximum value among all the accepted trials e For other parameters the values in the trial chosen as the Best The best values are highlighted in the left part of this section with a grey background On the left side above the measured parameters the following appears in order from top to bottom for each trial e If the trial is accepted By default the software accepts all trials The user can discard some of them but these trials won t be deleted from the archive when the user saves and exits from this panel At least 1 trial must be accepted e If the trial is the best one This selection is automatically determined using the ATS criteria but the user can select another trial as the best By changing the selection of the best tri
93. ederatincterrenatemasneisinrtienneenee nance patna 25 EI ee een 26 M Devices supplied with a dongle key csscssscsscssccsccssccsccsscssccsscsscnsccsscsscnsccsscsscnscsscsscnscesscsscnscesscsscescssonsoesees 26 E Devices supplied without a dongle Key nun 26 een aa een ae an TUT aa TER EEE TE RE EEE NE A ELTA ERE EEE 27 Dongle management for devices supplied with a dongle key ccccccccccesseeccsceeseecceeeeeeceseeeeeeeseseueeeeeseaenesss 27 Device management for devices supplied without a dongle key ccccccssesseecceeeeseecceseeseeceeseeeeceeseueeseeeeageesss 27 C Functioning principles OF the software nennen TIEREN 32 La Ser E r A OAE AOA AA 35 E DRI WANS een 35 U NE KEDO a ee ee A A E 35 YS HA MEO SE a a ee ee ee A 35 Ai aches cash acta cana A AE A 35 racists ecacassaecena tntnaseadcanaseeicanasenicancsuadcungercdawonstodevarenciaananeadsanuesaisnacsnaannndenedaaaaennanasnsandewecensacnencaadonenseones 35 El Bee E ee 36 E Conor i piss cernapusaedena ssa tdecenavacnateatbagadetuainbnsaedugidutscanssosutentatiadinidvondigaeeeedgnasieadue a 36 E Re ABER II rine antes aces earn cna vata senda aastata nds eintpaeeada na sas ada a a ia 37 EB aisha atc aac tee ara aad ac ae eae 38 ae Sy ree ree E cee re ee ree eee eee cee AE E AE TE me eee ee E re ee ree ee ee Sree pre rere etre E E 39 E a ii cgsniaa ego co Hence aA eI eee 40 E System Administration 41 M i TE een 42 Be URE 300 4 0 11 EN RENAET N S
94. el see below Test editing D gt X Redo Abort To abort the trial press Abort To restart the trial press Redo Both these commands discard the current trial and don t save any data it is not stored in the archive Body Plethysmography TGV Raw pre 183 L TGV Raw post Bronchodilator The Body Box Post test is a Body Box test after bronchodilator administration comparing results before and after the administration Bronchodilators are administered during lung function studies to determine if the subject s airflow obstruction is reversible Bronchodilators can increase airway size by relaxing the smooth muscle Testing TGV RAW post BD New Test Body Plethysmography TGV RAW post BD Press the Testing tile in the home panel then Body Plethysmography and TGV RAW post BD or start a new TGV RAW post BD test from the subject database If no subject was selected in the top part of the panel there is no subject information when pressing the Testing tile in the home panel the software will open the Subject database If no visit card is present for the current day for the selected subject the New visit panel is opened before starting the test A panel will open with some graphs subject weight height BODY PLETYSMOGRAPHY POST BD p a SUBJECT DEMO 98 0 kg 195 cm I vu ih eh S Omnia 1 2 Start and perform the test as indicated in the previous section
95. ep2 60 mcg Step3 120 mcg BD 400 mcg _ 1 on AN w The panel is divided into three sections The graphs section reports F V and V t graphs for each step the FVC pre and all the steps of the bronchochallenge test the best trial only for each step The QC and notes section reports only the Technician notes the QC is displayed in the results section since it can be different for each step The results section is divided into two parts 158 Spirometry Bronchochallenge e The left side shows each parameter and each step the measured values and for FVC pre the of the predicted values Above the parameter list the step its color corresponds to the color of the curve in the graphs section the time of the trial the QC and the Fall FEV1 e Theright side shows a graph of the Fall FEV1 compared to the FVC pre or the percentage of the FEV1 compared to the FVC pre vs the administered dose concentration The drop down menus above the graph allow the user to choose if the graph must be drawn using the dose or cumulated dose when available for the x axis and the Fall FEV1 Fall FEV1 or its 1 complement FEV1 baseline for the y axis e Below the graph the agent dose that caused a 20 15 and 10 of the Fall FEV1 If at the first step the Fall FEV1 is gt 20 the agent dose is indicated as lt of the dose of the first step if the Fall FEV1 at the last step is lt 20 the agent dose is indicated as gt o
96. er s certificate of analysis and press OK Wait till the end of the calibration gt X Redo Abort During the manoeuvre press Redo in order to restart press Abort to cancel CH4 Analyzer New Gain Gain 800 1400 Gain J fero mv Zero mv 5 300 Zero mv Delay ms Delay ms 400 1200 Delay ms Zero Hw Zero Hw 0 511 Zero Hw Response Time ms Response Time ms 0 400 Response Time ms CO Analyzer New Gain Gain 800 1400 Gain Zero mW Zero mv 5 300 Zero mv Delay ms Delay ms 400 1200 Delay ms Zero Hw Zero Hw 0 511 Zero Hw Response Time ms Response Time ms 0 400 Response Time ms Analyzers Pressure mmHg New Valid Range 500 700 Previous Sampling Flow mL min New Valid Range 500 750 Previous Press OK to accept the check Cancel to abort and Factory Setting to restore the factory settings Calibration Gas calibration 81 Body Box calibration CI This function allows the user to perform the two calibrations of the Q Box Body Box Calibration To start the calibration press Body Box calibration in the Calibration panel BODY BOX CALIBRATION is Leakage Check Calibration Another panel will open in which you can select which calibration must be performed Note The box must be empty without the patient the door closed the O CO cylinder open and the Q Box unit switched on in order to perform these checks Wait at least 2 minutes after cl
97. es Utilities 49 Restore Database restore the database from a previously backed up file Device Manager open the device manager for configuring all connected devices Customize Report customize the report User Accounts open the user accounts interface Event log open the event log for support purposes The Lal and Ba icons allow you to navigate through the different pages of the panel Note Backup and restore tiles are available in the Stand alone version only and for Administrators only Broncho Challenge protocols Broncho Challenge Protocols In this panel you can select the broncho challenge protocol to be used for broncho challenge tests The protocol can be selected among one of the predefined protocols or can be customized by the user both by modifying an existent protocol or creating a new one 50 User interface settings and utilities Utilities BRONCHO CHALLENGE PROTOCOLS subject gender age weight height d SUBJECT DEMO Male 46 98 0 kg 195cm Name Options Modality Nebulizer Output mL min Delete Protocol Broncho Constrictor Agent Broncho Dilator Agent AN ERNST MCEI Unit of Measurement MCI Agent Name pgentwame sabuanc sepa agent pose Cuma ee New Step Select an existent protocol A protocol can be selected under the field Name All the related information will appear in each field after having selected it Delete an existent protocol It is possible
98. est curves 3 Best according to the three highest values of DLCO values e Restore the last save Restore E Test results View To view a test press View button in the left part of the subject database In this panel data and graphs are not editable by the user Test results are accessed also by pressing Save amp Exit in the Edit panel Lung Diffusing Capacity CO Diffusing Capacity DLCO Test 173 DLCO SINGLE BREATH RESULTS subject gender weight height d SUBJECT DEMO Male 97 0 kg 195cm Computer OC rechnician oc TE Technician Notes Breath hold Jones and Meade Accepted Trials NormalRange Pred Pred zscore mL min mmHg 30 09 45 14 37 61 DLCO corr mL min mmHg 30 09 45 14 37 61 DLCOWA mL min mmHg L 5 406 609 5 07 VA L 6 28 9 42 7 85 TLC DLCO L 6 28 9 42 785 DM mL min mmHg Ve mL Interpretation DLCOWA mL min mmHg L The panel is divided into three sections The graphs section show the graph for the selected DLCO trial The QC and notes section is the same as described above in Test editing The results section is divided into two parts e The left side shows a graphical interpretation of the results e The right side the mean value for each parameter is shown together with the normal range the predicted value the of the value with respect of the predicted and the Z Score if enabled in the Predicted settings In the left side two bars are shown for DLCO corr and
99. esults Both New and Bronchochallenge allow the user to repeat the current step performing a new trial of the current step or to go to the next step or to one of the next steps performing the first trial of the new step 160 Spirometry Bronchochallenge Lung Diffusing Capacity General warnings nn Aa Me The device must be enabled in the Device Manager it must be properly connected to the PC with the appropriate communication port selected and it must be enabled to perform this type of test The name shown in the top part of the panel must correspond to the subject performing the test if a subject has not been selected the Subject database will be opened when a test is selected If a visit card does not exist for the current testing date the New visit panel will be displayed in order to enter the visit data DLCO testing must be performed using the ID 28 turbine or the PNT X9 with the sampling line connected The Quark must be properly connected to the PC with the appropriate communication port selected The DLCO cylinder must be open and the output pressure should be within 5 and 6 bars The mouthpiece should be connected to the flowmeter and the antibacterial filter appropriately For hygienic reasons the use of an antibacterial filter is strongly recommended In case of using the PNT X9 the use of an antibacterial filter is mandatory Note When performing several trials it is recommended that you wait at leas
100. et Browser will be opened and you will be redirected to the webpage of the scientific publication for this predicted set Note You must have an active Internet connection in order to access to the linked pages e If the Z Score must be shown near the results Show Z Score The Z Score is how many SD standard deviation the measured value is above or below the predicted value e If the predicted values can be extrapolated in case some data age weight height is outside the allowed range for the selected predicted set Use extrapolated predicted values Note Only a subset of the predicted sets can be extrapolated For the other sets the extrapolation cannot be applied and the corresponding predicted values are blank in case of extrapolation required even if the box is checked An example of predicted sets than can be extrapolated e For Spirometry ERS93 ERS93 extended ITS ITS extended Multicentrico Multicentrico extended adults Nhanes III Nhanes Ill extended adults and children Pheumobil Pheumobil extended Norma Mexicana Norma Mexicana extended adults e For Body Box ERS93 ECCS e For DLCO all the sets e For 6MWT all the sets 42 User interface settings and utilities Settings E International Q T N Settings Language English United States English United States Units of Measurement Symbol Units of Measu Changes applied after restarting OMNIA In this tab you can select
101. f the cumulated dose of the last step In other cases the displayed value is calculated with an interpolation according to the ATS Standard between the previous and the current step e The dose concentration causing a 20 of the Fall FEV1 is highlighted in red Edit Interpretation The buttons in the left part of the panel allows the user to e Continue the Bronchochallenge test Bronchochallenge Test starts from the last step performed e Start anew test New Test e Swap the FVC pre and the Diluent step Change the FVC pre step is replaced by the Diluent step This is the reference step for the calculation of the Fall FEV1 in all the subsequent steps e Edit the interpretation Edit Interpretation the panel Interpretation of the visit card is displayed e Print a report Print E Edit function Since the Edit button is not available in the Test results panel you can access the edit function from the subject database only When a step of the Bronchochallenge test is selected the Edit button will allow access to the edit panel of the selected step only while the View button will allow access to the test results summary as described above Spirometry Bronchochallenge 159 E How to switch from one panel to another Below is a flowchart that represents the navigation between the three panels described above perform a trial test editing and the test visualization Perform a trial Test editing Test r
102. g frequencies gt 1 5 Hz 90 breaths minute may lead to errors and those lt 0 5 Hz 30 breaths min may cause problems with the controlled leak of the body plethysmograph system It is possible to use a metronome to give rhythm to the patient G L sRaw Multi sRaw 2 To capture a sRaw press one of the two above buttons The first one captures a single sRaw the second one more than one sRaw sequentially as defined in the Body Box settings The graph and the measured value are shown in the corresponding box in the lower part of the screen The values shown are calculated starting from the predicted TGV Note When the test has been completed the sRaw will be recalculated starting from the actual TGV if performed It is normal that the real time sRaw measurements are different from the one shown when the test is completed unless the calculated TGV is equal to the predicted one or no TGV are performed during the test BOA cx 3 The above button allows the alignment of the loop with the axes origin 4 Capture at least three sRaw within 5 the difference between the higher and the lower value divided for their mean value must be lt 0 05 to guarantee repeatability of the manoeuvre TGV test 1 The patient must breathe at a respiratory frequency of about 60 breaths minute at least during the occlusion S TGV 2 To capture a TGV press the above button The graph and the measured value are shown in the corresponding box in
103. he F V graph the following predicted values if available are reported e MEF25 MEF50 and MEF75 with a circle e FVC with a rhombus e PEF with a horizontal line In the V t graph the following predicted values if available are reported e FEV1 with a circle e 6s according to the ATS standard with a vertical line e FVC with a horizontal line The bold curves correspond to the best insp and best exp QC and notes etz Barely Passing Technician QC In this section the following are displayed e An automatic quality control by the PC about the trials reproducibility not editable by the user e A quality control entered by the technician e Notes entered by the technician The quality control is graded in 6 levels A excellent B good C satisfactory D barely passing E F failing The PC quality control is graded according the following table Grade Acceptable Manoeuvres n And or other Required Conditions A gt 2 And best 2 FEV1 matched within 100mL B gt 2 And best 2 FEV1 matched within 200mL C gt 2 And best 2 FEV1 don t matched within 200mL 156 Spirometry Bronchochallenge F 0 None After the first trial the QC grade can only be D if the manouver is acceptable or F After the second trial the QC grade can become A B or C Note The quality control criteria are different from those of the FVC pre Results Accepted Best EXP Best INSP Step 3 Agent Data Metacholine 30
104. he best value for each parameter is shown together with the normal range the predicted value the of the value with respect of the predicted and the Z Score Measured values are displayed in italics if they are out of the normal range A scroll bar allows the user to scroll the parameters in order to view all of them The normal range is defined by the LLN ULN range as set in the Predicted settings The Z Score is how many SD s standard deviation the measured value is above or below the predicted value displayed only if enabled in the Predicted settings The best value is chosen according to the following criteria e For main parameters except for FEV1 FVC the maximum value among all the accepted trials e For FEV1 FVC the ratio between the Best FEV1 and the Best FVC e For other parameters the values in the trials chosen as the Best EXP for expiratory parameters and the Best INSP for inspiratory parameters The best values are highlighted in the left part of this section with a grey background On the left side above the measured parameters the following appear in order from top to bottom for each trial e If the trial is accepted By default the software accepts all of the trials The user can discard some of them but these trials won t be deleted from the archive when the user saves and exits from this panel At least 1 trial must be accepted e lf the trial is the best one inspiratory and expiratory This selection is a
105. he equilibrium In this phase the Body Box pressure column oscillates around the zero Under the volume time graph a countdown is shown Note The PNT can always be re zeroed by pressing the ZERO button Ensure that the patient is disconnected from the breathing valve pm Vent Valve 2 When the phase is over the vent valve closes and the pressure monitored in the right column oscillates following the patient s breaths If the value drifts towards higher or lower values the thermal equilibrium was not reached and it is necessary to open the vent valve by pressing the icon VENT VALVE 3 When the vent valve closes after a time specified in the Body Box settings observe the pressure column and if necessary repeat the previous step until the pressure no longer drifts 4 At this point the system is ready for the test Ask the patient to breathe quietly with the nose clips supporting their cheeks with their hands gt 5 Press START to start the test and the visualization of the measured data Body Plethysmography TGV Raw pre 181 sRaw test oe 1 The patient must breathe at a constant rate If the above button is OFF he she can breathe at current frequency otherwise ON the frequency must be faster than normal about 1 breath second 60 breaths minute The physician must indicate to the patient if he she needs to increase or decrease his her respiratory frequency in order to normalize the breath Pantin
106. he installation During the installation the following dialog boxes will open COSMED Omnia InstallShield Wizard Setup Type Select the setup type that best suits your needs 1 Click the type of setup you prefer Description Complete lt Back Next gt Cancel Select Complete to begin the complete installation including all the features select Custom to customize the installation If you select Custom the following dialog box will open COSMED Omnia InstallShield Wizard Select Features Select the features setup will install Select the features you want to install and deselect the features you do not want to install COSMED Omnia Files 104576 K Description COSMED Drivers OF Change Space Required on C 104516 K Space Available on C 983551 2 K lt Back Newt gt Cancel You can select the following options e install Omnia files mandatory to install the software e install COSMED device drivers mandatory to use the COSMED devices with the software 5 If you are not logged as Administrator enter the Administrator password when required by the software Click Yes to confirm and proceed Installation Software installation 19 Program name setup exe Verified publisher Unknown File origin Hard drive on this computer To continue type an administrator password and then click Yes mamma Password V Show details 6 When the installation is finis
107. hed the program will confirm that the installation has been completed successfully E Open and close the software When the installation is complete a Cosmed program group will be added to the Windows Start Programs and an icon will be added to the desktop Important note The Suite Software if installed and the Omnia Software are not compatible Do not run both software programs together Before starting one of the two software programs please close the other Running the software for the very first time just following the installation or after resetting the password ADMINISTRATOR ONLY Connect the USB dongle key for devices with a dongle key stand alone version or an authorized device for devices without a dongle key stand alone version to the PC Note For the Network version it is not necessary to connect the USB dongle key if supplied nor the device in order to start the software A dongle or a device is necessary in order to connect to the device e g for calibration or testing purposes Open the Windows Start menu and select COSMED Cosmed Omnia Cosmed Omnia or press the Cosmed Omnia icon on the PC desktop The following panel will automatically opened when the software is started 20 Installation Software installation a User Name Password Type the User Name admin and the password admin Press OK Change Password Old Password New Password Confirm New Password A new dialog box will ap
108. hing valve PNT and antibacterial filter System dead space the resistance of the system System resistance how long the shutter is closed during a test Shutter closing timeout the number of sequential sRaw captured with a single control Multi sRaw consecutive capture the algorithm to be used for the Raw calculation Raw algorithm Three algorithms are selectable sRaw 0 5 uses the linear portion of the sRaw loop between inspiratory and expiratory flow rates of 0 5 I s sRaw 0 2 uses the linear portion of the sRaw loop between inspiratory and expiratory flow rates of 0 2 I s sRaw Fmax is the parameter line connecting the maximum flow points the Erlenmeyer flask volume for simulated tests Erlenmeyer Flask Vol 46 User interface settings and utilities Settings E Export Q PR N Settings Export to PDF Available fields tos SSN i Subject Hospital ID wf First Name wl Last Name b D O B dog Gender wd Test date Jor Report date t Report Type Zen 0 Gof Gel 96t _9or Open PDF file after exporting E This tab allows you to select the standard filename and path for exporting the reports in pdf format The File Name allows you to define the name to be assigned to the file Press a link under Available fields to enter a value for one of the fields listed or type the chars in the box in order to create the filename template If the format selected is for example d l f
109. hs per minute the apnea valve is closed and patient is asked to perform short and rapid breaths While the patient try to breathe he she expands the gas within the lungs and causes the pulmonary volume to increase Consequently the body box pressure increases since its volume decreases When the patient exhales the opposite occurs In healthy individuals there is a little difference between the FRC measured with nitrogen wash out technique or other dilution techniques and the TGV measured by means of a Body Box This is not true for patients with particular pulmonary pathologies for these patients the TGV is often much higher than the FRC Parameters measured during the tests include the following Symbol sRaw cmH20 s Specific Airway Resistance cmH20 I s Airway Resistance M Parameter U Ww GAW I s cmMH20 Airway Conductance TGV L Thoracic Gas Volume V V Inspiratory Reserve Volume Inspiratory Capacity Ra G IR C SGAW 1 cmH20 s Specific Airway Conductance TLC pleth Total Lung Capacity RV pleth Residual Volume RV TLC pleth Motley Index TGV TLC pleth TGV TLC ratio Raw Tot cmH2O s l Total Airway Resistance Raw ins cmH2O s l Inspiratory Airway Resistance Raw exp cmH2O s l Expiratory Airway Resistance E Performing a test The software allows three test types 1 TGV Raw pre 2 TGV Raw post Bronchodilator 3 Asimulated TGV for verification only 178 Body Plethysmograp
110. hthe GDT Proto sisissscsssnssvciavssavcsdnessvecasnssesebnnsdvacnobsnusedsaaannssehaannedscenternnbuaseadenadeenouneavdsdansaens 107 HM Processing the EDT mMessare sense eine 107 What the software allows to do with incoming GDT files 2220s222220esnennennnnnesnnnnnennnnnnnnnnnnennnnnnennnnnennnnnn 107 How to process a GDT message 6301 OF 6302 avvisscciscrsncscassscacvvceracdaarsaceaceerereasaocnceveeraedansaasas sacs teeteesoesassncsaesseenenss 108 FIOW t processa GUT message 05 21 nee er ee TREE 109 US INS TVS UII ee ee ee ee ee een 112 UsingthePNT PFX Sp SPIRO PFT Q 50x Se 112 UVC OC ALONG acts sarap A E ne ee ee ee 112 Ed Forced Vital Capacity PIE nee ana 113 E Perlorma FVC pre Bastian renden een een rennen siehe 114 BR TEST anne nee 116 CN AIDING sates ioe oon E P AEE A E A TA AEAEE E NAA E FA AA E A AEE A E A T 117 Slaten OSS P N EA AAA TE A E T E I E A E T 118 ROE Se ee ee ae nase 118 TE oa A 119 i Pediat MEON NE sarcina eaa EAE ETE E Ea 121 Er Slow Vital Capacity een 122 E Vet E AE E A E E eae Ae A E aT Aa 122 E F eE a A ATNA AR 124 CN E A AEN N AE EIE E A ovens E IAEE AEN PEN AEE ee E A T A A er ee 125 OF anad NO ae ua ee 126 ESS ee Te GET ee 126 Me Tr 1 Pe EEE EEELEINE ERLERNEN SEE EINEN SPEER EEE ENLNSAEDENLENSEEIRIHERAEDENLEFSEURTLENSENERLUNSEREILENGEN 128 O Maximum Voluntary Ventilation nee 129 E Poa O a O N 129 MM TEST elo a E A S EAEE A E A A E AE A N EAE E Tr TT E E rrr rT rrr rr
111. hy Test execution overview TGV Raw pre Test includes three different manoeuvres 1 sRaw specific Airways Resistance 2 TGV Thoracic Gas Volume 3 SVC Slow Vital Capacity The order of the manoeuvres is not necessarily the one mentioned above The only constraint is that the SVC must be performed immediately after a TGV Note The maximum test duration is 5 minutes After that time the test automatically ends and the measured values are saved The thermal equilibrium as defined in the Body Box settings is not included in these 5 minutes Preliminary operations Testing Body Plethysmography TGV RAW PRE ih New Test Body Plethysmography TGV RAW PRE Press the Testing tile in the home panel then Body Plethysmography and TGV RAW PRE or start a new TGV RAW PRE test from the subject database If no subject was selected in the top part of the panel there is no subject information when pressing the Testing tile in the home panel the software will open the Subject database If no visit card is present for the current day for the selected subject the New visit panel is opened before starting the test A panel will open with some graphs Body Plethysmography TGV Raw pre 179 subject weight SUBJECT DEMO 98 0 kg gt 2 6 E o lo lo x m BODY PLETYSMOGRAPHY 0 0 000 Veni cmH20 RF Pbox 075 rm 3 35 0325 8 0 m 0 25 2 5 075
112. ian Notes Accepted Trials NormalRange Pred Pred zscore FVC 4 69 6 69 120 FEVI 3 72 5 40 124 FEV1 FVC FEV1 FVC 67 1 90 7 105 PEF PEF 8 15 12 13 140 FEF25 75 FEF25 75 2 79 6 21 130 MEF25 MEF25 1 27 3 83 98 MEF50 MEF50 3 44 7 78 124 AACC TOOK le AATCC TCO le EITFATEE The panel is divided into three sections graphs QC and notes and results G The button in the upper left part of the panel allows the user to start a new trial New The Save amp Exit button allows the user to exit the edit panel and saves the results By pressing Save amp Exit the Test results panel will be displayed see below In this section of the panel the F V and V t graphs of the accepted trials are shown The curves are colored according to the results section In the F V graph the following predicted values if available are reported e MEF25 MEF50 and MEF75 with a circle e FVC with a rhombus e PEF with a horizontal line In the V t graph the following predicted values if available are reported e FEV1 with a circle Spirometry Forced Vital Capacity pre 117 e 6s according to the ATS standard with a vertical line e FVC with a horizontal line The bold curves are the ones corresponding to the best inspiration and best expiration QC and notes Computer OC Technician QC Technician Notes In this section the following are displayed e An automatic quality control by the PC
113. ient requires a longer expiratory time to provide an adequate alveolar gas sample The following is an example of a correctly performed test N 0 3 Gas CHA CO Time N i i i Wash out Vol e Sample IVC a TLC i l JONES ERV FRC i OGILVIE RV 0 1 2 3 4 5 6 i Time Volume Time Correct manoeuvre terree Stepwise inhalation or exhalation Maximum exhalation not completed exhaled volume larger than inhaled volume Exhaled gas leak Inhalation too slow eevee Transient overshoot from high flows and changing gas temperatures Tips for obtaining acceptable DLCO testing efforts 1 Ask the patient to perform the simulated test see below as many times as necessary until he she is comfortable with the procedure prior to performing the test 164 Lung Diffusing Capacity CO Diffusing Capacity DLCO Test 2 Open the cylinder and the pressure regulator completely 3 Assure that the patient s inspiration IVC DLCO is at least 90 of the maximum SVC 4 Maintain the apnoea time between 9 and 11 seconds 5 Obtain a sampling volume near 1000 ml Patients with severe obstructive lung disease may not have the ability to meet all of the conditions described above In such cases DLCO measurements may not be completely accurate but can still be used when making comparisons to prior DLC
114. imported or created an imported table imported table if a linearization table was already imported for the selected serial number or an existing table latest table if a linearization table was already created for the selected serial number Wait until that the red dot in the lower right part of the screen becomes green Calibration X9 Linearization tables 75 Volume Error Volume Error O 100000 200000 300000 400000 500000 600000 700000 Pressure A D IN 7 25 50 75 100 Volume L Pressure A D Omnia 1 2 Perform strokes at different flows in order to complete all the 8 green bar on the left of the graph Each bar fills in if the stroke flow is within a predetermined range corresponding to that bar X9 LINEARIZATION TABLES Volume Error O 100000 200000 300000 400000 500000 600000 700000 Pressure A D Pressure A D Omnia 1 2 During the strokes in the upper right section the measured volume and its relative error both for inspiration and exhalation using the existent and the current tables are shown while in the lower right section two graphs show the linearization tables one for the existent table the other one for the current table The data for current table are updated in real time according to the changes to the existent table 76 Calibration X9 Linearization tables D 9 x E Redo Zero Abort Stop During the manoeuvre press Redo in order to restart press Zero to
115. imum Voluntary Ventilation DLCO Single Breath DLCO Intrabreath TGV Raw TGV Raw post BD OOOO OO U O OOOO OOOO OOK On the left side a list of all COSMED devices that can be interfaced with this software is shown To enable disable the communication of a device with the software please check uncheck the Enabled checkbox To select the communication port click on the corresponding drop down menu under the Port column and select the proper item To select the flowmeter used with this device click on the corresponding drop down menu under the Flowmeter column and select the proper item Note For stand alone devices the flowmeter selection must be done on the device itself For these devices the device manager reports a On the right side you can select which device is the default one for each test By clicking on the Show button you can see the serial number s of the connected device s only if you use the device without dongle lt 4 Upload Firmware To upload the firmware to a device please select the device in the list and click on Upload firmware the software will send the firmware stored on the hard drive to the selected device A progress bar is displayed during the transmission Note When uploading the firmware to a device with a Bootloader up to 1 5 excluded at the end of the transmission the SW confirms the upload but the firmware could hang on 99 In this case a manual reset
116. irmware without having a valid licence otherwise the software and or the device will become unusable 26 Installation License management Note If you connect another device when the software is running please close and restart the application in order to acquire the proper licenses E Licensers Licensers is an external program supplied with the Software Omnia It can be accessed opening the Windows Start menu and selecting COSMED Cosmed Omnia Licensers It allows to manage the licences on the device or on the dongle access them update them for future software and firmware releases and obtaining useful information about them Dongle management for devices supplied with a dongle key For these devices the Dongle management tab must be used EM COSMED Licenser elic Management Read Information Update Dongle License Device Management Dongle Management Dongle unique key 4b41fa19 2f6b 4266 8fa6 5561de5 Serial Number 2012129995 Device ID Authorized clients Trial expiring date Never Optiond Authorized In the Read Information Tab press Read Information in order to obtain the license information contained in the dongle key EN COSMED Licenser elic Management Read Information Update Dongle License Select license Device Management Dongle Management In order to update the license on the dongle key please open the Update Dongle License tab and press Select License Select
117. l that the red dot in the lower right part of the screen becomes green Start the trial following the next steps 1 Breathe normally 168 Lung Diffusing Capacity CO Diffusing Capacity DLCO Test 2 When the message appears press start during a maximal exhalation subject gender age weight height DLCO INTRA BREATH MEASURE ps SUBJECT DEMO Male 46 98 0 kg 195 cm CH4 CO Flow L s Volume L 85 Pred VC 10 Time s Omnia 1 2 o gt 3 Instruct the patient to inhale the DLCO gas mixture up to a TLC level At the end of inspiration ask the patient to exhale slowly to Residual Volume while maintaining a constant flow rate between 250 and 750 ml s The flow rate is highlighted with a green horizontal bar the flow graph must remain within this bar as long as possible 4 When the manoeuvre is completed press Stop or wait for the automatic end The software will display the Trial edit panel see below To abort the trial press Abort To restart the trial press Redo Both these commands discard the current trial and don t save any data it is not stored in the archive Lung Diffusing Capacity CO Diffusing Capacity DLCO Test 169 E Trial editing subject weight height DLCO SINGLE BREATH TRIAL EDIT SUBJECT DEMO 97 0kg 195cm 2 Dead space VDf mL VDs mL Restore VDa mL Correction Factors COHb CO Back Pressure TLC DLCO for Obstructed Subjec
118. le 46 98 0 kg 195 cm BODY PLETYSMOGRAPHY SIMULATED RF Pbox PMouth cmH20 P3ox cmH20 Omnia 1 2 Start and perform the test as indicated in the previous section the user can capture TGV only 186 Body Plethysmography Simulated TGV Limitations of the measurement method Below are some limitations of this procedure according to the international scientific community Overestimation of TGV in subjects with severe obstruction or induced bronchospasm unless slow panting speed ie approximately 1 cycle s is maintained Erroneous measurement of TGV Raw or sGaw due to improper panting technique Excessive pressure fluctuations or signal drift during panting may invalidate TGV Raw or sGaw Non panting measurements have been suggested for use in children or others who have difficulty mastering the panting maneuver Non panting maneuvers in plethysmographs with built in thermal leaks may invalidate TGV or Raw measurements Computer determined slopes of either TGV or Raw tangents may be inaccurate All slopes should be visually inspected and adjusted according to an established laboratory procedure Excessive abdominal gas or panting techniques that employ accessory muscles may increase the measured TGV due to compression effects Plethysmography is a complex test Careful calibration of multiple transducers is required Attention to frequency response thermal stability and leaks is necessary
119. m the test Check A ways use it for this test if you want to use the selected device every time this test is started Wait until that the red dot in the lower right part of the screen becomes green Start the trial 130 Spirometry Maximum Voluntary Ventilation subject weight height whee James Bond 79 0 kg 170cm pS a w 3 3 S Time s Omnia 1 0 The curves are updated in real time When the effort is complete press Stop or wait for the automatic end The software will display the V t graph the parameters and the predicted values For a description of the panel see Test results and editing below To abort the trial press Abort To restart the trial press Redo Both these commands discard the current trial and don t save any data it is not stored in the archive Iw New Repeat the trials by pressing New until the desired number of manoeuvres has been obtained Please note that in a single visit there can be only one test per type each of them including all the performed trials This means that all the MVV trials performed during a visit i e in the same day are stored under the same test E Test editing amp Edit The test editing panel shows the parameters measured in the trials performed during this test and can be accessed through the Edit button appearing when the near the selected test is pressed or at the end of each trial Spirometry Maximum Voluntary Ventilation 131
120. m the test edit panel it shows the details of the selected trial and it allows the user to select the steps during which the subject performed an IC subject gender age weight height SUBJECT DEMO Male 46 98 0 kg 195 cm Summary m pm Baseline Dyspnea 0 0 Baseline Fatigue 0 0 Other symptoms None Suppl 02 No Lmi 50 P Syst mmHg 120 mmHgo Pred FEVI L 456 03 00 Time min Steps Data Time mr HR bpm SpO2 EV mL Iv mL IV Max RF 1 mit VE Limit Mrk Isic Delete 00 15 66 98 1002 758 19 6 19 7 0 00 30 78 98 1182 859 21 7 25 7 00 45 85 97 1226 971 24 1 29 6 01 00 89 97 1369 20 4 279 01 15 91 97 1640 19 0 01 30 94 98 1783 RF 1 min 01 45 86 97 2225 02 00 83 97 1740 88 97 1856 89 97 1896 97 2588 97 1894 IBIEEIIEEEE EEE Time min The panel is divided into four parts test data measured data and two graphs The test data section of the panel contains the test data that was entered in the Spiropalm unit before the test If some data are erroneous or were not entered they can be edited The measured data section contains the measured data presented every 15 seconds all the parameters are the mean of the measured values in a 15 seconds period except for the IVmax which is the maximum value in this period Six Minute Walk Test The Six Minute Walk Test 199 It is p
121. maneuvers may be considered acceptable if the open shutter panting maneuver shows a relatively closed loop particularly in the range of 0 5 to 0 5 L s Body Plethysmography Viewing and editing test results 195 Six Minute Walk Test ee The Six Minute Walk Test E Overview The Six Minute Walk Test is a test that can be performed on the Spiropalm 6MWT only and it is downloadable in the software OMNIA Note The test cannot be performed through the software The software allows viewing and editing of the test only To download the test from the Spiropalm 6MWT please refer to the corresponding section of this manual Receiving data from the unit page 102 E Test editing F Edit The test edit panel can be accessed through the Edit button appearing when the near the selected test is pressed or from the test results panel subject gender f weight height t SUBJECT DEMO Male 98 0 kg 195 cm Sup 02 flow Min 6MWD Baseline Dyspnea Final Dyspnea Baseline Fatigue 0 Final Fatigue 6MWW kgxm 53900 Other symptoms None SpO2 and Cardiovascular BaselineSpO2 96 Avg SpO2 97 Final SpO2 Min SpO2 97 T lt 88 mm ss 00 00 T dSpO2 gt 4 P Syst mmHg 120 mmHg 80 Final HR 6MWD Max HR Peak VE Peak RF Min BR Min SpO2 T lt 88 mmiss T dSpO2 gt 4 mm ss The panel is divided into four sections summary results and two graphs The Save amp Exit button allows the user to exit the edit
122. midity Env RH e The temperature Flowmeter Temperat and the humidity Flowmeter RH at the flowmeter we suggest to maintain the default values 34 C and 100 respectively e Ifthe BTPS correction must be applied on the inspiration Apply Inspiratory BTPS and or on the expiration Apply Expiratory BTPS Note Acceptable ranges for these values are the following Environmental temperature 10 40 C Environmental pressure 400 800 mmHg Environmental relative humidity 0 100 Flowmeter temperature 21 37 C Flowmeter relative humidity 0 100 If you enter values outside of these ranges when you press OK they will not be stored they will revert to the last valid entered value For the environmental parameters if the device has an embedded sensor this value will be overwritten by the measured value when a test is started At this time only the environmental temperature sensor is included in the devices User interface settings and utilities Settings 37 E Spirometry Ox N Settings Environment and BTPS Autoscale FW and VA for small curves Use breathing valve Quark PFT Print best FVC 2 trials Whole FVE manoeuver on Wit plot Show OC Messages In this tab you can select e The autoscale for F V and V t curves must be activated Autoscale F V and V t for small curves The autoscale doubles the scale for both flow and volume if the measured values and the predicted values are small in the
123. n the software is not used Logout session timeout min After this time the software will automatically logout and you are required to enter your credentials user name and password another time e The interval time for changing the password Password expires in days After this time for safety reasons you are required to change your password for accessing the software Changes will be applied only after restarting the software User interface settings and utilities Settings 41 E Predicteds Q N Settings General ME Un her ae ATS ERS 2005 Pred 1 674 5D et Spirometry GLI Link Environment and BTPS Spirometry GDT Printout Header System Administration DLCO ECCS Link Body Pletysmography ERS93 ECCS Link Six Minutes WalkTest Enright and Sherrill Calibration DLCO Body Box Export Showzscore X About Use Extrapolated predicted values jj In this tab you can select The algorithm for LLN lower limit of normal and ULN upper limit of normal calculation LLN ULN Calc e For each test group the default predicted set in use This is the default predicted set in each visit card when it is created It is possible to use a different set for specific users to be specified when creating a visit card see page 96 By clicking on the arrow at the right side of each field it is possible to list all the options for this field By clicking on the link the Intern
124. n the top part of the panel there is no subject information pressing the Testing tile in the home panel of the software will open the Subject database If no visit card is present for the current day for the selected subject the New visit panel is opened before starting the test A panel will open with the V t graph Spirometry Slow Vital Capacity post Bronchodilator 143 subject weight height bile etl James Bond 96 0 kg 195cm A Volume L 45 Time s Omnia 1 0 Explain the procedure to the subject prior to beginning the test breathe normally then perform a maximal inspiration followed by a slow maximal exhalation for the EVC or perform a maximal exhalation followed by a slow maximal inspiration for the IVC When the subject and the software are ready press Start to perform the trial Select a device Quark PFT with dongle B Always use it for this test If more than one device was enabled in the device manager a window will appear asking the user to select which device will perform the test Check A ways use it for this test if you want to use the selected device every time this test is started Wait until that the red dot in the lower right part of the screen becomes green The following dialog box is displayed Agent Salbutamol ka Unit of Measure ment Enter the agent the unit of measurement if necessary and the dose Administer the agent to the subject 144 Spirometry
125. nd 59 79 0 kg 170cm da dx Change Password Users Management Roles Management Change Password change the password of the current user Users Management open the users management utility editing reserved to the Administrator only User interface settings and utilities Utilities 57 Roles Management open the roles management utility editing reserved to the Administrator only Change Password Change Password In this panel you can change your password by typing the old password and the new password in the proper fields Change Password B Old Password New Password Confirm New Password Press OK to confirm Cancel to abort Users management editing reserved to the Administrator only Users Management The users management panel allows the Administrator to add users delete users or the ability to request one or more user to change the password Other users can only view the information 58 User interface settings and utilities Utilities USERS MANAGEMENT subject gender weight height SUBJECT DEMO Male 98 0 kg 195 cm BS 8 Login Name First Name Last Name Inactive Change PWD 1st Login PWD never expires Roles admin Administrator Administrators Add User support Technical Support PFT Technicians UserName First Name Last Name Physicians 8 Technical Support x Delete User 9 YS Reset Password The panel is divided in two sections the users list on the lef
126. nge or start a new Broncho Challenge test from the subject database If no subject was selected in the top part of the panel there is no subject information pressing the Testing tile in the home panel of the software will open the Subject database If no visit card is present for the current day for the selected subject the New visit panel is opened before starting the test A panel will open with the F V and V t graphs Spirometry Bronchochallenge 151 subject gender weight height FVC POST BC MEASURE James Bond Male 96 0 kg 195cm pe 3 u 3 Volume L Explain the manoeuvre to the subject prior to testing the same as the FVC pre breathe normally then perform a maximal inspiration followed by a maximal forced exhalation When the subject and the software are ready press Start to perform the trial Select a device Quark PFT with dongle Always use it for this test If more than one device was enabled in the device manager a window will appear asking the user to select which device will perform the test Check A ways use it for this test if you want to use the selected device every time this test is started Wait until that the red dot in the lower right part of the screen becomes green 152 Spirometry Bronchochallenge Step 1 of 10 Bronchoprovocation Protocol Metacholine Dose bi Agent Dose Select the protocol Prev Step Next Step The first step is displayed Us
127. nnsnesnnnnnnnnnnnnennnnnnnnnnnnennnnnnennnnnnnsnnnnennnnnnenn 164 E Perform a DLCO test single breath standard Method cssccssscssccesccesccecccsccesccnsccnsccesscesccecccecccsccsccsccescees 165 m DIE DIES BES nennen essen 167 w TUST 170 TE EN ee ern 171 Body Plethysmography Q B0X El GGA WARE een 176 E Preparation TOR AT ee Deere ee 176 Peet PCa SON ee ee E ENTER 176 El Testexec tion overview nennen 178 MB POP BT ee ee 178 LL TV IR WIDE era Reeeeeeeeeee 179 Preliminary ODE a ON ee ee sence ent a a sac ece versie EEEE EET EEE 179 Thermal gu DEU ON Seen ee ee see ee 181 SR LE ee a ne ee ee nee 182 A TEST ARE E EE E E EVER EN ERSUNIEERRER EENE ER ERLEERE EA 182 STORE NENNT ne TE ee 182 EI 3 HOLE nn E A RR ee Rennen 183 El GW Raw post Bronce OC alt RR Ra 184 E Fo eC na E NE N A AE TAA OEN RAA 184 eho i Ct ene ee ran E ee 185 Bl Fo ee arina ed rende sncedoetaeeutumtnniedennteataupiduenapeees 185 L Limitations of the measurement method ssccccccccsssssseccccccccsssssececcccccesssseeeecccenacssseecccceeeaasseeeecceeeaassseeeeees 187 O Viewing and editing test results ee 188 ao a ernennen 188 62 10 NS ATE EA E a arse EE ETE ET E E E AE A E E ET E E T E ET 189 Ocana NOTES aoran E E E OA 189 AED i P patentee A E EN caine coe a A E E E E E TT E A E E 189 w ORO DE ae 190 w E a E A A 191 EESE EN EE E E A E AE A E E E A A EA E A ERE E 191 WIN NEN a a re E ee En 192 E E A A ee E E A E E ee E E E E ae 193
128. of measurement if they are enabled measured if the quantity must be shown in the graph only one at time can be shown in the graph the minimum and the maximum measured value e Onthe bottom left the sample time for the measurement of the quantities In the top bar press mV or um to switch from showing measurements in mV and in the current unit of measurement press All to enable all the quantities None to disable all the quantities and Stop to exit from control panel Control panel for Quark series In order to start the control panel data acquisition press Start Select a device Quark PFT with dongle If requested select the device CONTROL PANEL name vae um Enabled showin max Analyzers Pressure 567 mmHg CH4 Analyzer 0 279 CO Analyzer 0294 Barometric Pressure 746 mmHg Ambient Temperature 20 8 C Body Box Pressure o 0 0002 cmH20 P0 1 Pressure 0 0 cmH20 1 ml s 2500 ml s 0 05 16 48 Relative Humidity 57 MIP MEP Pressure o 0 cmH20 Analyzers Flow ml min Mouth Pressure 0 01 cmH20 Rocc Pressure 0 00 Dosimeter Pressure 14 4 SpO2 Oximeter 0 Heart Rate SpO2 0 Heart Rate TTL ANT 0 0 Flowmeter Tidal Flow Omnia 1 2 The panel is divided in four sections e On the right side a graph of the selected value vs time e Inthe center buttons and controls for hardware control of the device cylinders valves trimmers 90 Calibration Con
129. on 73 X9 Linearization tables SPIRO PFT Q Box This function allows the user to create or import the linearization tables for the PNT X9 Note The linearization tables are specific for a single X9 If you change the X9 used you must import or create the linearization tables for this new X9 alk X9 Linearization Tables To start the procedure press X9 linearization tables in the Calibration panel X9 LINEARIZATION TABLES Volume Error Volume Error Volume L Pressure A D Omnia 1 2 E Import existent linearization tables To import an existent linearization table press the Upload button X9 Linearization Tables serial number Linearization ta pe 593 2103 2013 u u 74 Calibration X9 Linearization tables Enter the X9 Serial Number and search through the C icon the file containing the linearization table Press OK to confirm or Cancel to abort An acoustic signal will confirm the operation success E Create new linearization tables Press Start Select a device Quark PFT with dongle If requested select the device X9 Linearization Tables Serial Number exe Linearization tables on device 593 21 03 2013 Apply ChangesTo Enter the X9 Serial Number select if the breathing valve is used or not and select the Apply change to The changes can be applied to the generic table generic table if no linearization table was already
130. on t save any data it is not stored in the archive G New Repeat the trials by pressing New until the desired number of manoeuvres has been obtained Please note that in a single visit there can be only one test per type each of them including all the performed trials This means that all the FVC postBD trials performed during a visit i e in the same day are stored under the same test E Test editing amp Edit The test editing panel shows the parameters measured in the trials performed during this test and can be accessed through the Edit button appearing when the near the selected test is pressed or at the end of each trial 138 Spirometry Forced Vital Capacity post Bronchodilator subject weight FVC POST BD EDIT SUBJECT DEMO 98 0 kg 7 N g Computeroc E Technician QC f E Agent Data Salbutamol 400 mcg Accepted Trials Change Change Pred zscore FVC 0 04 120 FEVI 0 10 126 FEVI FVCh FEV1 FVC 107 PEF PEF 136 FEF25 75 FEF25 75 137 MEF25 MEF25 108 MEF50 MEF50 125 MACCTCOR le MACC7COL The panel is divided into three sections graphs QC and notes and results G The button in the upper left part of the panel allows the user to start a new trial New The Save amp Exit button allows the user to exit the edit panel and saves the results By pressing Save amp Exit the Test results panel will be displayed see below Graphs In this section of the
131. order to exchange the information This option permits these files to be deleted at the end of the import procedure e The directory Data Path the filename File Name and the report directory PDF Path for exporting data Reports will be exported in PDF format If you click the icons near the paths you can choose the folder in the standard Windows browse dialog box User interface settings and utilities Settings 39 E Printout header Ow N Settings Header line 1 COSMED Header line 2 Via dei Piani di Monte Savello 37 00041 Albano Laziale Rome Header line 3 Department Lab Room Logo COSMED Puknsany torien Ensen In this tab you can set the information which is to be printed at the header of all reports It is also possible to add a logo by clicking on the square near the Logo tag Only bitmap bmp dib rle JPEG jpg jpeg jpe jfif gif tif tiff and png files can be selected We advise to use images not too big and with the same aspect ratio of the field in order to avoid distortions due to adaptation of the logo to the field size 40 User interface settings and utilities Settings E System Administration Q MR N Settings Login session timeout min Mm Changes applied after restarting OMNIA Password expires in days Note This tab is available for the Administrator only In this tab you can set e The interval time for automatic logout whe
132. ore Above the data the agent and the dose referring to the best step en E Edit Interpretation New Test The buttons in the left part of the panel allow the user to e Edit the test Edit the panel shown under Test editing is displayed e Start a new test New test The New Test is enabled if the test is performed on the current day e Edit the interpretation Edit Interpretation the panel Interpretation of the visit card is displayed e Print a report Print 142 Spirometry Forced Vital Capacity post Bronchodilator _ Slow Vital Capacity post Bronchodilator Bronchodilators are administered during pulmonary function studies to determine if the subject s airflow obstruction is reversible Bronchodilators can increase airway size by relaxing the smooth muscle This test consists of comparing the results between a reference SVC and the SVC obtained after administering the drug SVC postBD The reference SVC is normally a SVC pre a SVC test performed during the same visit The software will allow the user to perform the SVC postBD if the SVC pre is not performed In that case the software uses the predicted SVC value as the reference E Perform a SVC post BD test Testing Spirometry SVC post BD A New Test Spirometry SVC post BD Press the Testing tile in the home panel then Spirometry and SVC post BD or start a new SVC post BD test from the subject database If no subject was selected i
133. osing the door before starting the check Errors during the calibration procedures can be due to e Unit off e _RH TA probe not properly connected e Door not closed e Cylinders closed or with insufficient pressure e Pneumatic tube not connected or damaged e Gasket damaged e Other minor causes 82 Calibration Body Box calibration E Leakage check Leakage Check To start a leakage check press Leakage check in the Body Box calibration panel LEAKAGE CHECK Pressure cmH20 Omnia 1 2 Press Start Select a device Quark PFT with dongle If requested select the device Wait till the end of the calibration Calibration Body Box calibration 83 LEAKAGE CHECK 8 ps E i Omnia 1 2 During the manoeuvre press Redo in order to restart press Abort to cancel Press Accept to accept the entire check E Polytropic factor Calibration To start the polytropic factor check press Calibration in the Body Box calibration panel 84 Calibration Body Box calibration CALIBRATION g I 5 Omnia 1 2 Press Start Select a device Quark PFT with dongle If requested select the device Wait till the end of the calibration Calibration Body Box calibration 85 CALIBRATION 30 Time s Omnia 1 2 During the manoeuvre press Redo in order to restart press Abort to cancel Press Accept to accept the entire check 86 Calibration
134. ossible to select if during a step the subject performed an IC manoeuvre The graph in the upper right section contains a representation of the mean IV bar graph and maximum IV dot graph every 15 seconds The graph in the lower right section contains a representation of the IC Ve and RF vs time mM Test results View To view a downloaded test press the View button in the left part of the subject database In this panel data and graphs are not editable by the user Test results are accessed also by pressing Save amp Exit in the test edit panel SIX MINUTE WALK TEST RESULT ee gg aires 5 a SUBJECT DEMO 46 98 0 kg 195 cm Walk Test Summary Test Time mm ss 06 00 ee ee eeo 6MWD m 550 Baseline Dyspnea 0 Baseline Fatigue 0 6MWW kgxm 53900 SpO2 and Cardiovascular Baseline SpO2 96 Min SpO2 97 P Syst mmHg 120 Baseline HR bpm 66 Ventilatory response Baseline FEV1 L 4 30 Baseline VE U min 13 4 Baseline BR 92 Baseline RF l min 16 6 Baseline IC L 3 45 SpO2 and Cardiovascular SPO2 Oxymeter 03 00 Time min Ventilatory response 03 00 Time min ORCKOKS The panel is divided into four sections summary results graphical interpretation and two graphs The summary and the graph sections are the same as described above in Test editing The results section shows a graphical interpretation of the results Three bars are shown the Six minute distance the distance covered during
135. owmeter verification The flowmeter verification is useful in order to check the flowmeter response at different flows using the gains stored at the end of the last calibration ATS recommends a weekly linearity check Flowmeter Verification To start the check press Flowmeter Verification in the Calibration panel FLOWMETER VERIFICATION Volume L Omnia 1 2 Begin with the syringe piston pushed all the way in Press the Start button Select a device Quark PFT with dongle If requested select the device Measured Wome Enor 0 Calibration Flowmeter verification 71 Flowmeter Configuration Select if the breathing valve is used or not Wait until that the red dot in the lower right part of the screen becomes green Perform strokes at low mid and high flows in order to let the red icons in the upper right corner become green k These icons show the status of the check for low mid and high flows both for inspiratory and expiratory strokes they are red if the corresponding check is not completed and green if it is completed Each check is completed if a stroke has the mean flow within the range see table below and the measured volume within the standard ATS range 2 9 3 1 I for a 3 litres syringe Min range VELTS Max range Low Ol s 0 3 I s 0 6 l s 0 6 I s 1 l s 1 4 I s High Al s 6 I s 8 I s In the left side of the panel you can see the F V graph In it six colored bands
136. ows the parameters measured in the captures performed during the selected trial and it allows the user to select the captures to be used for the results of the selected trial The capture edit panel is accessible from the trial edit panel and it allows the user to edit each single capture sRaw TGV or SVC E Test editing F Edit The test edit panel is shown at the end of each test it shows the parameters measured in the trials performed during the test and it allows the user to select the trials to be used for the final results It can also be accessed through the Edit button appearing when the near the selected test is pressed or at the end of each trial subject gender age weight height st tt ot SUBJECT DEMO Male 46 97 0 kg 195 cm Technician OC u Accepted Trials NormalRange Pred Pred zscore cmH20 s N cmH2O s lt 12 00 cmH20 s L cmH20 s L lt 2 24 1 cmH20 s 1 cmH20 s gt 0 08 L cmH20 s L cmH20 s gt 0 44 L 3 11 4 66 Flow L s PMouth cmH20 4 76 7 14 6 80 10 20 L L L at L L L 1 86 2 80 The button in the upper left part of the panel allows the user to start a new trial New The Save amp Exit button allows the user to exit the edit panel and saves the results By pressing Save amp Exit the Test results panel will be displayed see below 188 Body Plethysmography Viewing and editing test results 60 45 0 1 cmH2O 30 Flow L S PMouth femH2o AS
137. panel the F V and V t graphs of the accepted trials are shown together with the graphs of the FVC pre black thin curves if performed The curves are colored according to the results section In the F V graph the following predicted values if available are reported e MEF25 MEF50 and MEF75 with a circle e FVC with a rhombus e PEF with a horizontal line In the V t graph the following predicted values if available are reported e FEV1 with a circle Spirometry Forced Vital Capacity post Bronchodilator 139 e 6s according to the ATS standard with a vertical line e FVC with a horizontal line The bold curves are the ones corresponding to the best insp and best exp QC and notes lt da D Barely Passing Technician QC f E In this section the following are displayed e An automatic quality control by the PC about the trials reproducibility not editable by the user e A quality control entered by the technician e Notes entered by the technician e The quality control is graded in 6 levels A excellent B good C satisfactory D barely passing E F failing The PC quality control is graded according the following table Grade Acceptable Manoeuvres n And or other Required Conditions A And best 2 FEV1 and FVC matched within 150mL After the first trial the QC grade can only be D if the manouver is acceptable or F After the second trial the QC grade can become at most C if both manouvers are
138. passing E F failing The PC quality control is graded according the following table Grade Acceptable Manoeuvres n And or other Required Conditions After the first trial the QC grade can only be D if the manouver is acceptable or F After the second trial the QC grade can become at most B if both manouvers are acceptable and the VC matches between 200ml Only after the third trial can the QC grade become A Results Accepted Trials Normal Range Pred Pred 5 03 6 87 5 03 6 87 The results section is divided into two parts e The left side shows all the measured parameters for all the performed trials e The right side shows the best value for each parameter is shown together with the change compared to the FVC pre both absolute and relative and the of the predicted value Above the data the agent and the dose referring to the best step If the SVC pre is not present the change compared to the SVC pre absolute and relative is not displayed Measured values are displayed in italics if they are out of the normal range A scroll bar allows the user to scroll the parameters in order to view all of them Spirometry Slow Vital Capacity post Bronchodilator 147 The normal range is defined by the LLN ULN range as set in the Predicted settings see page 41 The best value is chosen according to the following criteria e For main parameters the maximum value among all the accepted trials e For other paramete
139. pear the software requires you to change the password To do so enter the old password admin a new password selected by the user and the confirmation on this new password Then press OK Warning Please be very careful to store this new password in a safe place Don t forget it If you forget the password perform the password reset according to the instructions in the section Reinstall the software page 24 This reset can be performed only by the system administrator Installation Software installation 21 Running the software for the very first time NEW USER ONLY A new user is a user added by the Administrator This section is reserved for the first access to the software by an user just added by the Administrator Connect the USB dongle key for devices with a dongle key standalone version or an authorized device for devices without a dongle key standalone version to the PC Note For the Network version it is not necessary to connect the USB dongle key if supplied nor the device in order to start the software The dongle connected to the server is enough A dongle or a device is necessary in order to connect to the device e g for calibration or testing purposes Open the Windows Start menu and select COSMED Cosmed Omnia Cosmed Omnia or press the Cosmed Omnia icon on the PC desktop The following panel will automatically opened when the software is started User Name NewUser Password Type the
140. perform the baseline press Abort to cancel press Stop to end the operation V Accept Press Accept to accept the results Calibration X9 Linearization tables 77 Gas calibration This function allows the user to calibrate the gas analyzers E Connections In order to calibrate the analyzers you should disconnect the sampling line from the reader and connect it to the front panel of the Quark The cylinders used for the calibration must be properly connected to the rear panel of the Quark and the output pressure should be between 5 and 6 bars Before starting the calibration you should make sure that the reference values are correct see the Setting Reference Values section Note Cellular phones should be turned off to eliminate potential electrical interferences Note If a gas absent error appears during the calibration please check that the cylinder s residual pressure is above 10 bar and that the cocks are open 5 bar lt press lt 6 bar press gt 10 bar E Start the calibration panel Gas Calibration To start the calibration press Gas calibration in the Calibration panel 78 Calibration Gas calibration GAS CALIBRATION 2 DLCO Calibration Another panel will open in which you can select which gas calibration must be performed DLCO calibration Warning After turning the Quark on you should allow the system to warm up prior to beginning any calibration The D
141. ph for the best trial The QC and notes section is the same as described above in Test editing The results section is divided into two parts e The left side shows a graphical interpretation of the results e The right side shows the best value for each parameter together with the normal range the predicted value the of the value with respect of the predicted and the Z Score if enabled in the Predicted settings On the left side a bar is shown for VC Near this parameter a colored bar with an indicator representing the current status of the subject The bar also reports the normal range Edit Interpretation New Test The buttons on the left part of the panel allow the user to e Edit the test Edit the panel shown under Test editing is displayed e Start a new test New Test The New Test is enabled if the test is performed on the current day e Edit the interpretation Edit Interpretation the panel Interpretation of the visit card is displayed e Print a report Print 128 Spirometry Slow Vital Capacity pre _ Maximum Voluntary Ventilation Measurements of Maximum Voluntary Ventilation are commonly performed when exercise testing is also being conducted MVV measurements are an index of the subject s maximum ventilatory capacity The procedure consists of breathing in and out as deep and fast as possible for 12 seconds The expired volume during the 12 second period is then extrapolated to 1 minute Parameters m
142. press the corresponding section in order to view the data that cannot be displayed for space reasons On the left there are some buttons that allow the user to 94 Database management Subject database a New Subject add a new subject Mew Visit add a new visit ih New Test add a new test open the trend analysis view the selected test print a report for the selected subject a summary or a specific test E Subjects Add a new subject a New Subject Press the New Subject button in the left part of the panel Database management Subject database 95 NEW SUBJECT General S ss EEE 2 First or GE Nore ast Name _UUUUUUUUUUUUUUU ug Select 3 date idd rarvyyyy i Gender MA hic Go 7 Contacts Address D UUUUTTTTTUOTOTOTTOVUN Zip Code UUUTTTTTT Country UUUTUUTTOT OTOT T TOT OOUN Mobile Phone TS Work Phone oMr ZOE LLLULUUTTTTTTTTTTTNVN Fax Number Other Data Insurance Company i Comments Insurance Number ORORO The New subject panel is divided into three sections General Contacts and Other data Enter the required data Mandatory fields are highlighted with a red border Press Save to save the data Cancel to cancel the operation The Save button activates only when the mandatory fields are completed with valid data When data are saved another panel will open for creating a visit card with the visit data see below Edit a subject F Edit Select
143. r PC Requirements nee 14 O Converting existing COSMED database files into OMNIA software ssssssssessssssssesssesosesosssosseosseossecosesosesosssoseeosseoe 15 M Using the COSMED_DB_Converter program ssesssssssssessssecsssecsscecsssecsscecsssecsssecsscecsssecsssecsssecsssecssescsssecsseeeseseess 15 Installing the COSMED_DB_ Converter program cccccccsseccccesccccenecccceseccceussececeuscceceeceesunececsuseceseuecesseecetsuneeetees 15 Running the COSMED_DB_ Converter program for importing the archives ccccsscccccssececeeseceeeeceeeeseceeeeseeeeees 16 EI Sonwareinstalatioi sssrinin ee 18 m O ON a E E ENE ANE E EAO A E O EEE 18 BE Genera Warnes Ano NOTES annona E 18 E Installing the software Standalone installation ssessessessesseoseoseosecsesesseesesseoseosecseoseoseosssessessessesseoseosecssoeesees 19 mM Oben and close the Sonwa E een 20 Running the software for the very first time just following the installation or after resetting the password ADVINISTRA FOR ONLY ironii e ea ee 20 Running the software for the very first time NEW USER ONLY cccccessecccessececeseceeeeeceeeueeeeeeecesseneceeeeeeeeees 22 R nnine the software normalVe en ann 23 VOSS THESOH WAL en Senor uaii annie E E Stina acai een T 24 HM Reinstall the software program MaiNteENANCE ssccsseccssccsscccescccscccnscccssccnscccnsccscccescccscccescccseccescccseccusceoeeces 24 Bi Ss a SO AN Spans ctaratac
144. r Try rr ree 131 GE a N E E E E 132 OC aNd Natel een O 133 FRO OUIIE ga A E E E EEA A ERTLELRREBER 133 EAE A E A E E EI ET ada a hada anda A A E E E E E T T S 134 O Forced Vital Capacity post Bronchodilator scccsscsosssccssssccssscccessccsececessccucsceceseccusesececeseuscsececeseussseceseseueseees 136 aAa e a D E AEE E E EE E EE EE EE E EEE E E 136 E Test CONTIG piip 138 OI A ose A A ee E E E pest an en ee une ee A ts 139 OG NC TAT SG E A E E E E E E E A E E EA P E E A E P E E E EHE SEERE BEE 140 FSS UI ne Eee Eee 140 a EE E E E E E E E EAE EE E I E EE E E EE atcha FR NUDE E A E E E 141 O Slow Vital Capacity post Bronchodilator neueren 143 E Poerform 3SVE Host BD Tesi uiri 143 E EE PEA TEIE A EE AO AE er ae TOA A AEA E EA rT ee 145 AD A EE A E A ee A A A E A AE A A T 146 acana TIO ra ee Eee 147 RE UNS EE T EE ATEN E AET A EA E T A ATE 147 A ig E A E ETE E ANE E TE ET P E E E PE EE er 149 ER Bronchochalon eenn EE EEE EE 151 E Perform a Bronchochallenge test nee 151 E Test COINS riei III 154 PFT Q Box Lung Diffusing Capacity El GE ES een 162 BE PIE LIE OT een er ee EEE EEE 162 O CO Diffusing Capacity DLCO Test ea 163 M DLCO single breath standard technique ssessesssssssessecsecsecseosecsecsecsesescecsecsessessecsecsecsecsssessecsecsessessecsecseessoe 163 E DLCO single breath test procedure sun anne 163 Tips for obtaining acceptable DLCO testing efforts cuss2ssseesnessesn
145. r is shown together with the normal range the predicted value the of the value with respect to the predicted and the Z Score Above the data the agent and the dose referring to the best step Spirometry Slow Vital Capacity post Bronchodilator 149 en Edit New Test Interpretation The buttons on the left part of the panel allow the user to e Edit the test Edit the panel shown under Test editing is displayed e Start a new test New Test The New Test is enabled if the test is performed on the current day e Edit the interpretation Edit Interpretation the panel Interpretation of the visit card is displayed e Print a report Print 150 Spirometry Slow Vital Capacity post Bronchodilator _ Bronchochallenge The most common indication for performing bronchial challenges is to diagnose hyperresponsive airways Subjects may demonstrate normal baseline pulmonary function testing and show little or no response when administered a bronchodilator despite repeated complaints of respiratory symptoms chest tightness wheezing cough In such cases bronchial challenges can be used to confirm or rule out a diagnosis of hyperreactive airways Indications for bronchial challenges include the following e Diagnosing Asthma e Confirming a diagnosis of Asthma e Documenting the severity of airway hyperresponsiveness e Following changes in airway hyperresponsiveness Subjects with hyperreactive airways will demonstrate a
146. rameters are not customizable by the user See the Test editing section below for more information E Perform a FVC pre test Testing Spirometry A New Test Spirometry Press the Testing tile in the home panel then Spirometry and FVCpre or start a new FVCpre test from the subject database If no subject was selected in the top part of the panel there is no subject information when pressing the Testing tile in the home panel the software will open the Subject database If no visit card is present for the current day for the selected subject the New visit panel is opened before starting the test A panel will open with the F V and V t graphs 114 Spirometry Forced Vital Capacity pre subject g weight height James Bond 96 0 kg 195 cm pS a v 3 Volume L Explain the manoeuvre to the subject prior to testing breathe normally then perform a maximal inspiration followed by a maximal forced exhalation When the subject and the software are ready press Start to perform the trial Select a device Quark PFT with dongle Always use it for this test If more than one device was enabled in the device manager a window will appear asking the user to select which device will perform the test Check Always use it for this test if you want to use the selected device every time this test is started Wait until that the red dot in the lower right part of the screen becomes green Start the trial
147. range 4 7 s and 0 8 respectively e lf the spirometry tests are performed with the breathing valve Use breathing valve Quark PFT This function is enabled for Quark series only e If the three best FVC trials must be printed Print best FVC 2 trials instead of the best one This setting applies to the FVC pre and post trials only e If aSpirogram is shown instead of the V t plot Whole FVC manoeuver on V t plot This is applied only for the tests performed with this options activated and only for the real time visualization e Ifthe Quality Control messages must be shown at the end of the test Show QC messages 38 User interface settings and utilities Settings Q Pr N Settings GDT Enabled W Importing Settings Se CAUsers Public Documents GDTIN a System Administration Predicteds File Name sonal Delete file after import Calibration DLCO Body Box Exporting Settings erat Sees C AUsers Public Documents GDTOUT About File Name a CAusers Public Documents GDT PDF a GDT is a standardized protocol used by the software for the exchange of data between health facilities In this tab you can select e Ifthe GDT is enabled GDT enabled e The directory Data Path and the filename File Name for importing data in the Importing Settings section e If the protocol files must be deleted after the import Delete File after import The GDT exchange protocol uses files in
148. re before installing the new one E Uninstall the software Insert the installation CD start the installation procedure and select Remove Note for uninstalling 1 0 version only Do not uninstall the software from the Windows control panel nor from the Start Cosmed Cosmed Omnia menu For uninstalling 1 1 version or higher Alternatively select Cosmed Omnia in the Windows control panel or select Uninstall Cosmed Omnia in the Start Cosmed Cosmed Omnia menu Follow the on screen instructions in the dialog boxes to complete the operation Installation Software installation 25 License management In order to allow the software and device to operate properly together both software and device must be authorized For database access and consultation only the Network version doesn t need a local authorization see below The authorization works differently depending on the device with or without dongle key E Devices supplied with a dongle key The devices supplied with dongle key must work together with an USB dongle key that contains the license for this software version FOR STAND ALONE VERSION ONLY When the software is opened it checks the license on the dongle and for this reason the dongle containing the license must be already connected to the PC If the software finds a valid license it will be started otherwise a message warns the user and the software will be closed automatically It is mandatory to connect th
149. response to the inhalation of challenging agents Methacholine or Histamine by displaying signs of airway constriction The testing procedure involves executing repeated FVC manoeuvres following the inhalation of pharmacologic agents according to an established protocol A subsequent decrease in FEV1 can be used to determine the presence and severity of bronchial hyperresponsiveness The PD20 or PC20 depending on the modality dose or concentration is the drug dosage that leads to a 20 reduction of the FEV1 with respect to the baseline value Parameters measured in bronchoprovocation testing include the following Symbol UM Parameter FallFEV1 Fall in FEV1 from baseline or post diluent PD10 or PC10 Provocative dose causing FEV1 to fall 10 from baseline PD15 or PC15 Provocative dose causing FEV1 to fall 15 from baseline PD20 or PC20 Provocative dose causing FEV1 to fall 20 from baseline The software associates all FVC efforts conducted throughout the procedure to the FVC pre baseline FVC obtained during that date s visit It is not necessary to perform an FVC pre The test can be compared to the diluent step the first step without bronchoconstrictor or to the predicted values if the diluent step is not present E Perform a Bronchochallenge test Spirometry Broncho Challenge New Test Spirometry Broncho Challenge Press the Testing tile in the home panel then Spirometry and Broncho Challe
150. rpretation the panel Interpretation of the visit card is displayed e Print a report Print E Predicted values interpretation Predicted values for Raw and sRaw are the maximum predicted for the patient It means that a lower value is positive thus the lower the value the more positive the result Predicted values for Gaw and sGaw are the minimum predicted for the patient It means that an higher value is positive thus the higher the value the more positive the result BE Check the test quality TGV maneuvers are acceptable when the displayed or recorded tracing indicates proper panting technique the loop generated against a closed shutter should be closed or nearly so 194 Body Plethysmography Viewing and editing test results The patient should support his her cheeks with the hands to prevent pressure changes induced by the mouth This should be done without supporting the elbows or elevating the shoulders Recorded pressure changes should be within the calibrated pressure range of each transducer The entire tracing should be visible Pressure changes that are too large or too small may yield erroneous results Thermal equilibrium should be evident tracings should not drift on the display or recording The panting frequency is approximately 1 Hz if the filter is not applied Frequency should be held constant for within testing session comparisons ie pre and post bronchodilator testing and serial testing Raw and sGaw
151. rs the values in the trial chosen as the Best The best values are highlighted in the left part of this section with a grey background On the left side above the measured parameters the following appears in order from top to bottom for each trial e If the trial is accepted By default the software accepts all the trials The user can discard some of them but these trials won t be deleted from the archive when the user saves and exits from this panel At least 1 trial must be accepted e If the trial is the best one This selection is automatically determined using the ATS criteria but the user can select another trial among the accepted ones as the best By changing the selection of the best trial the selected curve is automatically displayed and cannot be hidden e If the trial is shown in the graph The box can be selected or de selected determining whether the trial will be shown in the graph The Best trial cannot be hidden An Edit button represented by the icon By pressing this button it is possible to change graphically the EELV end expiratory level and the EILV end inspiratory level of the selected curve which detect the current volume Press OK to confirm changes or Cancel to cancel them The EELV and EILV are represented on the graph with dotted horizontal lines black for EELV and red for EILV The Vt and IC parameters under the graph are automatically updated each time the EELV and EILV values are changed
152. rtant Keynotes Below are important notes describing the organization of this manual This will make the manual easier to follow E Typographic keynotes Typographic keynotes used in the manual are as follows Style Description Bold Indicates a control or key to be pressed Italic Indicates a message displayed by the software E Availability of functions Not all the functions described in this user manual are available to every user Options are dependent on which device and which software options are purchased Similarly the software panels can differ from the ones shown in this manual depending on the device and the purchased options The icons listed below are for specific COSMED products and their configurations Icon Device s microQuark Pony FX Pony FX Flowsafe Pony FX MIP MEP Spiropalm Spiropalm Plus Spiropalm 6MWT SPIRO Quark Spiro PFT Quark PFT Q Box Q Box Quark PFT Body If a section only refers to a limited number of devices all of its subsections refer the same devices unless otherwise specified Note At this time this software is ONLY available for the devices specified above For all other COSMED devices the Suite Software is still required In order to update the existing archives to this software please read the installation chapter Please be careful and adhere to the recommendations described in the installation chapter in order to avoid archive corruption compatibility problems and sof
153. s indicated in the chapter Calibration ATS recommends a daily calibration Using the PNT PFX Sp SPIRO PFT Q Box Connect the PNT to the unit through its pneumatic line Calibrate if needed the PNT as indicated in the chapter Calibration Other operations gt N Instruct the subject to apply the nose clip N 112 Spirometry General warnings _ Forced Vital Capacity pre FVC testing is used to verify obstructive and restrictive lung disorders Quality control messages are available to ensure acceptable manoeuvres are performed for interpretation Parameters measured during FVC tests include the following Symbol UM Parameter FEF25 75 L s Mid exp flow between 25 75 FVC MEF25 L s Expiratory Flow when 75 of the FVC remains to be exhaled MEF50 L s Expiratory Flow when 50 of the FVC remains to be exhaled MEF75 L s Expiratory Flow when 25 of the FVC remains to be exhaled FEF50 75 L s Mid exp flow between 50 75 FVC FEF25 50 L s Mid exp flow between 25 50 FVC FEF75 85 L s Mid exp flow between 75 85 FVC PEFT ms Time to PEF 10 90 FEFO 2 1 2 L s Mid exp flow between 0 2 1 2 FIF25 75 L s Forced mid inspiratory flow Spirometry Forced Vital Capacity pre 113 PIFT ms Time to PIF 10 90 FIF 0 2 1 2 L s Mid insp flow between 0 2 1 2 MIF MEF50 MIF50 MEF50 ratio FEV1 VC Tiffenau index The first four parameters of the previous list are the main parameters These pa
154. se Select reports to print Summary FVC ATS FVIC Pre FVC Post BD SVC SVC Post BD MV DLCO Single Breath TGV RAW PRE TOV RAW POST BD 6MWT Select the report to be printed Press the Create Pdf button to export the report into pdf according to the Export settings see page 47 or Print to open the print preview If you press the Create Pdf button the pdf is saved as set in the Export settings and opened if selected in the settings otherwise a print preview will be displayed You can export a pdf file of the calibration report selecting File Export to PDF In the top part of the panel there are icons which allows you to Print the report Copy the selected text if any Zoom in the report Zoom out the report Set the zoom at 100 Fit the page width to the screen View the whole page View two pages Exporting tests with GDT protocol GDT Select a visit press the on the left of the visit and then the GDT button Tests will be exported in the previously selected folders as defined in GDT Settings see page 39 in PDF format together with a GDT message At the end of the operation a message will confirm its completion The exported GDT message GDT file type 6310 is a file containing the subject data the visit data the test data only for FVC SVC MVV DLCO and Q Box tests and a link to the PDF file Database management Subject database 101 E Tests Start a new
155. sponding calibration By clicking on Print you will access to the print preview Calibration Calibration archive 87 Print preview You can export a pdf file of the calibration report selecting File Export to PDF On the top part of the panel there are icons which allow you to i Print the report Copy the selected text if any Zoom in the report Zoom out the report Set the zoom at 100 z Fit the page width to the screen B View the whole page E View two pages 88 Calibration Calibration archive Control panel The control panel allows you to check the main hardware functions of the device Control Panel To access the control panel press Control panel in the Calibration panel The control panel will open Two different control panels are displayed depending on the device used Control panel for portable devices mQ PFX Sp In order to start the control panel data acquisition press Start Select a device Fony FX with dongle If requested select the device CONTROL PANEL une COS AmbientTemperature 200 C 199 202 Power Supply 4968 mV a 4961 4968 Turbine Flow 1620 1 n 4772 3316 Turbine Volume 400 u a m 236 3324 Omnia 1 2 The panel is divided in three sections Calibration Control panel 89 e Onthe right side a graph of the selected value vs time e On the top left a list of the measured quantities their measured values the unit
156. st FVC e For other parameters the values in the trials chosen as the Best EXP for expiratory parameters and the Best INSP for inspiratory parameters The best values are highlighted in the left part of this section with a grey background On the left side above the measured parameters the following appears in order from top to bottom for each trial e If the trial is accepted By default the software accepts all the trials The user can discard some of them but these trials won t be deleted from the archive when the user saves and exits from this panel At least 1 trial must be accepted e lf the trial is the best one inspiratory and expiratory This selection is automatically determined using the ATS criteria but the user can select another trial as the best portion By changing the selection of the best trial the selected curve is automatically displayed and it cannot be hidden e If the trial is shown in the graph The box can be selected or de selected determining whether the trial will be shown in the graph The Best trials cannot be hidden e Therank starting from 1 for the best trial The rank is according the FVC FEV1 starting from the highest value and decreasing The rank doesn t correspond to the trials sequence e The color representing this trial in the graph above It is not possible to customize the colors 1 The color of the check boxes can be white __ if selectable blue if de selectable or grey _
157. subject gender i i en SUBJECT DEMO Male rechnicon oc ES Technician Notes Accepted Trials Meas NormalRange Pred Pred MVV L min 150 5 MVV L min 150 5 156 5 MRF 1 min 38 0 MRF 1 min 38 0 MVt L 3 96 MVt L 3 96 MWt s 11 03 MWt s 11 03 The panel is divided into three sections graphs QC and notes and results The button in the upper left part of the panel allows the user to start a new trial New The Save amp Exit button allows the user to exit the edit panel and saves the results By pressing Save amp Exit the Test results panel will be displayed see below Graphs In this section of the panel the V t graph of the accepted trials is shown The curves are colored according to the results section The bold curve is the one corresponding to the best 132 Spirometry Maximum Voluntary Ventilation QC and notes Techricien oc EEG Technician Notes In this section the following are displayed e A quality control entered by the technician e Notes entered by the technician The quality control is graded in 6 levels A excellent B good C satisfactory D barely passing E F failing Results Accepted Best Show Rank Accepted Trials e 1 EEE Meas NormalRange Pred Pred zscore MW L min 150 5 MW Lmin 150 5 MRF 1 min 38 0 MRf l min 38 0 MWt L 3 96 MWt L 3 96 MVVt s 11 03 MVVt s 11 03 The results section is divided into two parts e The left side shows all the m
158. t and the roles list on the right The users list lists all the users that can access the software Two users are predetermined and cannot be changed nor deleted admin the Administrator and support for the technician who must service the software and or the device Other users can be added or deleted by the Administrator dt Add User In order to add a user press the Add User button A row will be added in the users list You can modify the fields by clicking on them The Inactive checkbox disables if checked the selected user it means that this user cannot access to the software until re enabled The Change PWD 1st login checkbox requires if checked the selected user to change his her password when he she authenticates next time The PWD never expires checkbox allows if checked the password to be valid forever independently from the system settings dx Delete User In order to delete a user select it and press the Delete User button Confirm the operation or cancel 4 Reset Password The Reset Password button allows one to reset the password of the selected user The next time he she authenticates he she will be required to create his her password i e an user reset a re initialization of the user as it was a new user The roles list lists all the roles defined in the Roles management panel see below For each user you can set the roles he she belongs to One or more roles can be
159. t on the left which shows the list of the stored subjects with their main data e Visits in the center which shows the list of the visits for the selected subject with their main data Please note that a list of the visits is displayed only when a subject is selected from the list on the left e Tests on the right which shows the list of the tests performed during a visit with additional info if available Please note that a list of the tests is displayed only when a visit is selected from the list in the centre and this visit contains one test at least Please also note that a test can include one or more trials Inside each visit card there can be maximum one test for each test type i e 1 FVC 1 SVC 1 MVWV All of the trials performed during the current visit are stored as trials of the single test and not as several tests For example if you perform three consecutive trials of FVC they are stored as three trials of the FVC test If you later perform but during the same visit two other trials of a FVC they will be stored as the trials 4 and 5 of the single FVC test of the current visit In order to find a subject you can type the subject name in the field in the top part of the panel A filter will be activated filtering all the subjects with the entered string in their name You can order each table by a desired field by pressing the corresponding column header The icons and bal allows you to respectively expand or com
160. t 5 minutes between trials Note After turning the device on wait at least the recommended warm up time before beginning calibration or testing procedures Notice Cellular phones should be turned off to eliminate potential electrical interferences E Patient preparation Calibrate the turbine or the PNT X9 as indicated in the chapter Calibration ATS recommends a daily calibration Perform a DLCO calibration see Calibration Connect the sampling line to the flowmeter and connect it to the breathing valve Instruct the patient to apply the nose clips The use of antibacterial filters is strongly recommended 162 Lung Diffusing Capacity General warnings CO Diffusing Capacity DLCO Test Diffusion can be defined as the flow of particles from an area of higher concentration to an area of lower concentration Measuring diffusion in pulmonary function laboratories can provide information about the transfer of gas between the alveoli and the pulmonary capillary blood Oxygen and Carbon Dioxide must move across both the alveolar capillary membrane and the blood plasma barrier during the diffusion process The rate of diffusion across these barriers is limited by several factors the surface area available for diffusion to take place the distance the gas molecules must travel the solubility coefficient of the gases in the liquid and the partial pressure gradient between air and blood and the density of each gas Me
161. t be performed in this step and the actuation time the duration of the delivery When creating a bronchodilator step please use the dose instead of concentration feature not active yet e Options Nebulizer output ml min enter the nebulizer output in ml min only if a dosimeter is used e Bronchoconstrictor agent enter the name of the agent agent name and its measurement unit unit of measurement Bronchodilator agent enter the name of the agent agent name and its measurement unit unit of measurement New Step By pressing the button New step you can add a step in the protocol In order to change the entered values please click on the desired field to change the shown value Please be careful to select the correct agent diluent bronchoconstrictor or bronchodilator and to enter dose instead of concentration when using a bronchodilator Steps are colored according to the administered drug o 1 Diet o Light blue for the diluent 2 Broncho constrctor 0 0625 Orange for the bronchoconstrictor e 7 Broncho dlator 4000 Green for the bronchodilator Other colors are used for 4 Broncho constrictor 1 Selected step grey 5 Bronche constrictor 4 Mouse over the step light grey 52 User interface settings and utilities Utilities x Delete Step By pressing the button Delete Step you can delete the selected step When all the data are entered press Save in order to save the proto
162. t editing amp Edit The test editing panel shows the parameters measured in the trials performed during this test and can be accessed through the Edit button appearing when the near the selected test is pressed or at the end of each trial 124 Spirometry Slow Vital Capacity pre SVC EDIT subject gender weight height SUBJECT DEMO Male 98 0 kg 195 cm p a Computer QC Technician QC D Barely Passing T E Volume h h N amp o n w Hw The panel is divided into three sections graphs QC and notes and results The button in the upper left part of the panel allows the user to start a new trial New The Save amp Exit button allows the user to exit the edit panel and saves the results By pressing Save amp Exit the Test results panel will be displayed see below Graphs Volume L In this section of the panel the V t graph of the accepted trials is shown The curves are colored according to the results section The bold curve is the one corresponding to the best Spirometry Slow Vital Capacity pre 125 QC and notes lt de D Barely Passing Technician QC In this section the following are displayed e An automatic quality control by the PC about the trials reproducibility not editable by the user e A quality control entered by the technician e Notes entered by the technician e The quality control is graded in 6 levels A excellent B good C satisf
163. t fq Membrane Diffusion 02 10 Time s At the end of the trial the trial edit panel is shown This panel is slightly different depending on the DLCO test performed single breath or intra breath but the main features are the same for both tests The trial edit panel shows the parameters measured in the selected trial and can be accessed at the end of the trial or through the u icon shown in the test edit panel above each trial The graph at the center shows the DLCO graph of the current trial In the graph vertical dotted lines show the limit of the washout and sampling volumes These limits are customizable by moving them through the mouse or by moving the sliders shown below the graph If the checkbox ATS criteria below the graph is checked these limits are not editable since they are calculated starting from the ATS criteria For the intra breath tests the green bar for the exhalation flow is also shown On the right four sections allows to change the default settings as set in the DLCO settings 1 Dead space allows to change the default dead spaces the meaning of each field is explained in the DLCO settings section 2 Correction factors allows to change the default correction factors the meaning of each field is explained in the DLCO settings section 3 Membrane diffusion allows to use this trial as one of the trials for the membrane diffusion test In order to do that please check the Enabled checkbox
164. test A New Test Press the New Test button in the left part ofthe panel Refer to the following chapters for test execution Alternatively in order to start a test it is possible to press the Testing tile in the home panel selecting the desired test In this case a subject must be already selected the name is shown in the top part of the panel and his her visit card must be already created his her anthropometric data are shown on the top part of the panel Otherwise the Database and or New visit panel is shown in order to respectively create select a subject and add a visit View a test View Select a test and press the View button in the left part of the panel Refer to the following chapters for test viewing Edit a test f Edit Select a test press the on the left of the visit and then the Edit button Refer to the following chapters for test editing Delete a test Delete Select a test press the on the left of the visit and then the Delete button Confirm the action by pressing OK or cancel the operation with Cancel Note All the test data all the trials of the selected test will be deleted Printing the results from test viewing Print When in a test viewing panel the Print button is pressed the print preview is shown You can export a pdf file of the calibration report selecting File Export to PDF On the top part of the panel there are icons which allows you to Print the
165. the PC and the Quark PFT with the appropriate communication port selected The Cal 5 CO 16 0 Bal N cylinder must be opened and contain a pressure between 5 and 6 bars The use of an antibacterial filter is mandatory Do not touch the Body Box the pneumatic tubes and the cart during the test O o ND Avoid air displacements in the room where the test will be performed e g a slamming door an opening window etc since the pressure transducers are very sensitive 10 When ending a test please wait for adequate air change inside the Body Box before starting another one Note Cellular phones should be turned off prior to testing to eliminate potential interferences E Preparation for a test Calibrate the PNT and the Body Box leakage and polytropic factor as indicated in the chapter Calibration Connect the PNT and the breathing valve inside the Q Box unit Patient preparation The equipment is adjusted so that the patient can sit comfortably in the chamber and reach the mouthpiece without having to flex or extend the neck The patient must be seated comfortably there is no need to remove dentures The procedure is explained in detail including that the door will be closed the patient s cheeks are to be supported by both hands and a nose clip is to be used Let the patient enter into the Body Box paying attention to avoid bumping the head while entering if necessary he she can use the proper handle Explain
166. the home panel then Lung Diffusion Capacity and DLCO Single Breath or start a new DLCO Single Breath test from the subject database Lung Diffusing Capacity CO Diffusing Capacity DLCO Test 167 If no subject was selected in the top part of the panel there is no subject information when pressing the Testing tile in the home panel the software will open the Subject database If no visit card is present for the current day for the selected subject the New visit panel is opened before starting the test A panel will open with the V t graph subject weight DLCO INTRA BREATH MEASURE SUBJECT DEMO 98 0 kg 5 o gt 30 Time s Omnia 1 2 Explain the manoeuvre to the subject prior to testing When the subject and the software are ready press Start to perform the trial Select a device Quark PFT with dongle Always use it for this test encima If more than one device was enabled in the device manager a window will appear asking the user to select which device will perform the test Check Always use it for this test if you want to use the selected device every time this test is started Test Options Simulated Select if the current trial is a simulated test The simulated test is useful if you wish to conduct a procedure without having the patient inhale CO and CH This function may be useful when familiarizing the patient with the manoeuvre prior to performing the actual test Wait unti
167. the license file to be sent to the dongle key The new license will be sent to the dongle and it will be updated accordingly Device management for devices supplied without a dongle key For these devices the Device management tab must be used Installation License management 27 EM COSMED Licenser 5 xj elic Management Device Management Dongle Management Device Selection Get Device Information Device Name Communication Port USB Discovery old models S N lt 2013020001 USB USE microQuark old models S N lt 2012033501 ysg Upload Firmware Discovery II Upgrade Device License microQuark F Pony Flowsafe USB Pony Fx USB Pony FX old models S N lt 2013020001 USB Pony MIP MEP Spiropalm Spiropalm 6MWT In the Device Selection tab please select the device currently connected to the PC When the device is selected the other tabs become active EM COSMED Licenser x alic Management Device Management Dongle Management Device Selection Get Device Information Selected device microQuark USB Upload Firmware en __Upgrade Device License _ Serial Number Model ID ee Device ID Software version authorization Firmware version authorization 4 20 Authorized clients In the Get Device Information tab press Read Information in order to obtain the license information contained on the device Press Clear cache in order to clear the cached files on the PC har
168. the lower part of the screen 3 The above button allows the alignment of the loop with the axes origin 4 Capture at least three TGV within 5 the difference between the higher and the lower value divided for their mean value must be lt 0 05 to guarantee repeatability of the manoeuvre SVC or IC manoeuvre Note The SVC or IC can only be performed immediately after a TGV For this reason the button to start this manoeuvre is enabled only if the TGV is the last capture 1 If necessary the patient can remove the mouthpiece and breathe between the TGV and the SVC Patients with severe dyspnoea may have difficulty performing the preferred VC method i e ERV immediately after TGV followed by a slow IVC To overcome this the patient can be instructed to take two or three tidal breaths after the panting manoeuvre prior to performing the linked ERV and IVC manoeuvres NG AG StartSVC Start IC 2 Start the SVC or the IC by pressing one of the two buttons shown above The Flow Pbox graph become blank The subject can perform the manoeuvre when he she wants 182 Body Plethysmography TGV Raw pre ANG AG Stop SVC Stop IC 3 At the end of the manoeuvre press one of the two buttons shown above the one corresponding to the performed manoeuvre End abort the test Stop When the test is completed press Stop or wait for the automatic end 5 minutes The software will display the test edit panel For a description of the pan
169. the procedure in detail including that the door will be closed the patient s cheeks are to be supported by both hands and a nose clip is to be used The patient is instructed to insert the mouthpiece in their mouth and breathe quietly until a stable end expiratory level is achieved usually 3 10 tidal breaths 176 Body Plethysmography General warnings Note Control of shutter closure includes a program to reopen it after 3 seconds TGV only to minimize patient discomfort and avoid the subject experiencing fear when s he is trying to breathe when the shutter is closed Patients should always be informed to remove the mouthpiece from their mouth in the event the shutter does not open or if the subject senses substantial difficulty breathing Instruct the patient to apply the nose clips Close the door The plethysmograph door is closed and time is allowed for the thermal transients to stabilize and the patient to relax normally 2 minutes Body Plethysmography General warnings 177 Test execution overview This test measures the TGV thoracic gas volume and the Raw airway resistance In particular the plethismograph relates pressure variations inside the Body Box with volume variations of the air within the lungs by means of the Boyle s law It states that under isothermal conditions the product of volume and pressure of a gas is constant During a panting maneuver respiratory frequency about 60 breat
170. to delete the selected protocol by clicking on the button Delete Protocol Confirm with Yes cancel with No Add a new protocol New Protocol To add a new protocol press the button New Protocol Protocol Name Test protocol Enter the protocol name in the dialog box and confirm with OK User interface settings and utilities Utilities 51 BRONCHO CHALLENGE PROTOCOLS subject gender age weight height d SUBJECT DEMO Male 46 98 0 kg 195cm a Name Options New Protocol Modalty nn E CO Nebulizer Output mL min Delete p ene Broncho Constrictor Agent Broncho Dilator Agent Unit of Measurement eel Unit of Measurement oe agent Name Agent Name TS New Step For the dilator step enter the dose in the given unit Omnia 1 2 Enter the required information in the fields e Options Modality enter the modality for defining each step Concentration the step is defined by entering the agent and the concentration for each step When creating a bronchodilator step please use the dose instead of concentration Dose the step is defined by entering the agent and the dose at each step Exercise the step is defined by entering the agent and the time for each step When creating a bronchodilator step please use the dose instead of time feature not active yet Dosimeter the step is defined by entering for each step the agent the concentration the breaths how many deliveries mus
171. transmitting the new firmware to the device it won t be possible to use the device with the Suite software the transmitted firmware is not compatible with the Suite software If SQL Server must be installed the installation can take several minutes 30 minutes and more depending on the PC and its configuration If SQL Server 2008 R2 is already installed in the PC the SQL administrator must coincide with the system administrator If it is not so during the installation procedure the SQL instance to which the database will connect will be required together with user name and password of the SQL administrator Please contact the IT department for proper installation COSMED Omnia InstallShield Wizard mE Database Serrer Select database server and authentication method Database server that you are installing to flocall SQLEXPRESS Connect using SQL Server authentication using the Login ID and password below Login ID Password lt Back Next gt Cancel 18 Installation Software installation Installing the software standalone installation Note The software is copyright protected and should only be installed from the original disk 1 Insert the installation CD into the CD ROM DVD ROM drive 2 Installation will begin automatically If the disc does not start automatically you will need to run Setup exe from your CD DVD drive Follow the on screen instructions in the dialog boxes to complete t
172. trol panel e On the top left a list of the measured quantities their measured values the unit of measurement if they are enabled measured if the quantity must be shown in the graph only one at time can be shown in the graph the minimum and the maximum measured value e Onthe bottom left the sample time for the measurement of the quantities J 50 x m ca All None Stop On the top bar press mV or um to switch from showing measurements in mV and in the current unit of measurement press All to enable all the quantities None to disable all the quantities and Stop to exit from control panel Calibration Control panel 91 Database management _ Subject database The subject database consists of Subject Cards Visit Cards and Test Cards which are displayed on one screen when the database is opened nia Database To open the database press the Database tile on the home panel DATABASE subject gender weight height SUBJECT DEMO Male 98 0 kg 195cm p Search by Name or SSN at New Subject fe Subject Visits ie eae oo a u 30 01 2014 Dr House FVC pre 23 01 2014 Dr House Slow Vital Capacity 29 10 2013 Dr House A Slow Vital Capacity post BD Salbutamol 400 mcg 28 03 2013 Dr House A FVC post BD Salbutamol 400 mcg Maximum Voluntary Ventilation TGV Raw TGV Raw post BD Salbutamol 400 mcg DLCO Single Breath Six Minute Walk Test The panel is divided into three sections e Subjec
173. tware crashes Getting started Important Keynotes 11 Installation _ Minimum Computer PC Requirements e 13 processor e Stand alone Network Client Windows Vista 7 8 8 1 32 or 64 bit Network Server Windows Server 2008 SP2 2008 R2 SP1 2012 e RAM4GB e HD with 500MB of free space e CD DVD drive e Monitor with resolution of 1024x768 or greater Available USB or RS232 port e GELB Available USB port e Mouse and printer which are compatible with the MS Windows operating system e PCand monitor compliant with the IEC60950 Standard e Acrobat Reader for referring to the installed user manuals DEE if using an external printer the printer must support PCL3 or higher language and be connected via USB Note The devices are not compatible with USB 3 0 ports Depending on the Operating System configuration it may be necessary to install one or more of the following packages e Windows Installer 4 5 redistributable e Microsoft Framework 3 5 redistributable e Microsoft Framework 4 5 redistributable e SQLServer 2008 R2 SP1 Express redistributable These packages are included on the installation CD however they are also available for download directly from the Microsoft website see below e http www microsoft com en us download details aspx id 8483 for Windows Installer 4 5 e http www microsoft com en us download details aspx id 30653 for Microsoft Framework 3 5 e http www microsoft
174. uite Software Important note The Suite Software and the Omnia Software are not compatible Do not run both software at the same time Before starting one of the two software programs please close the other 4 Install the Omnia Software please see the following section Software installation page 18 Note The Omnia Software can only be installed after backing up the old archives 5 Install the COSMED_DB_Converter program and import the old archives in the new software by means of the COSMED_DB_Converter program see below Using the COSMED_DB_Converter program Note If the Omnia Software is installed on a new PC please locate the Suite Software installation folder on the old PC and copy the entire folder in the new PC E Using the COSMED_DB_Converter program The COSMED_DB_Converter program allows you to import the old archives compatible with the Suite Software release 8 0 or higher into the new Omnia Software Installing the COSMED_DB_Converter program The installation of the COSMED_DB_Converter program is a standard Windows installation it is very simple to complete 1 Double click the installation file 2 Follow the on screen instructions to complete the installation 3 If you are not logged as Administrator enter the Administrator user name and password Installation Converting existing COSMED database files into OMNIA software 15 Program name setup exe Verified publisher Unknown File origin Hard
175. utomatically determined using the ATS criteria but the user can select another trial as the best portion After changing the selection of the best trial the selected curve is automatically displayed and it cannot be hidden e If the trial is shown in the graph The box can be selected or de selected determining whether the trial will be shown on the graph The Best trials cannot be hidden e Therank starting from 1 for the best trial The rank is according the FVC FEV1 starting from the highest value and decreasing The rank doesn t correspond to the trials sequence e The color representing this trial in the graph above It is not possible to customize the colors 1 The color of the check boxes can be white __ if selectable blue if de selectable or grey _ if not editable Select All Near these items on the left four buttons allow the user to e Accept all the trials Select All e Automatically select the best trial according to ATS criteria ATS that has the maximum FVC FEV1 value e Accept only the 3 best curves 3 Best according to the three highest values of FVC FEV1 values e Restore the last save Restore E Test results View To view a test press the View button in the left part of the subject database In this panel data and graphs are not editable by the user Test results can also be accessed by pressing Save amp Exit in the Edit panel Spirometry Forced Vital Capacity pre 11
176. wmeter calibration archive Control Panel open the control panel The Ldi and Ba icons allow to navigate through the different pages of the panel Calibration Running the Calibration program 67 Flowmeter calibration In this chapter the calibration procedure for both turbine Flowsafe and PNT X9 is described E Setup In order to perform flow and volume calibrations you should connect the syringe to the flowmeter of choice as shown in the picture below A flowmeter calibration is mandatory when you change the flowmeter when the ambient conditions temperature humidity and pressure change significantly and in all the cases you suspect that the measurements are not reliable anymore COSMED also suggests to repeat the calibration each week You should check that the correct reference values are used see page 44 before performing the calibration Note If a bacterial filter is used for testing you should also include one during the flowmeter calibration 5 n 10 5 11 13 8 4 9 1 Calibration syringe CO0600 01 11 2 Wrinkled tube A 108 300 012 3 Silicone tube C00311 01 20 4 1D18 turbine adapter C03047 01 20 5 Antibacterial filter A 182 300 004 6 Conic adapter C00063 01 20 8 PNT C02580 01 06 9 1D18 turbine C02500 01 04 10 PNT X9 C03600 01 05 11 ID28 turbine C03400 01 04 13 Pony turbine C02235 01 05 68 Calibration Flowmeter calibration Calibration procedure Note It is

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