omnia User Manual VII Edition Feb 2017

Table of contents Table of contents ... 3 Getting started ... 11  Overview of the manual ... 12  Important Keynotes ... 13  Typographic keynotes ... 13  Availability of functions ... 13 Installation ... 15  Minimum System Requirements... 16  Software installation ... 17  Introduction ... 17  General warnings and notes... 17  Installing the software (standalone installation) ... 17  Importing COSMED Suite archive into OMNIA ... 20  Open and close the software ... 23  The Domain - an introduction ... 23  Running the software for the very first time only - ADMINISTRATOR ONLY ... 23  Running the software for the very first time - NEW USER ONLY ... 24  Running the software ... 24  Quit the software ... 24  Modify/repair/remove software ... 25  Alternative way to uninstall the software (for OMNIA 1.1 or higher) ... 25  License management ... 26  Devices supplied with a dongle key ... 26  Devices supplied without a dongle key ... 26  Licensers ... 26 User interface ... 31  Functioning principles of the software ... 32  User interface ... 34  Dialog windows ... 34  Scroll bars ... 34  Data tables... 34  Fields ... 34  Shortcuts ... 34 Settings ... 35  Introduction ... 36  General... 37  Environment and BTPS ... 38  Calibration... 39

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 Flowmeter verification ...40  Predicteds ...41  Spirometry ...42  Br. Protocol/Dosimeter...43  Dead spaces and Resistances  DLCO

...44

...45

 Body Plethysmograph

...46

 Nitrogen Washout

...47

 Rocc

...48

 Respiratory Mechanics  CPET

...49 ...50

 REE ...51  System Administration...52  GDT ...53  Export ...54  Omnia Modules ...55  About...56 Utilities ... 57  Introduction ...58  Customize Views ...59  Dashboard customization ...60  Results customization...65  Customize Report ...66  Pulmonary Functions...66  Metabolic ...67  Header ...68  Metabolic Protocols...69  Add a new protocol ...69  Edit a protocol ...71  Duplicate a protocol...71  Delete a protocol ...71  Export and import a protocol ...71  Broncho-Challenge protocols ...72  Select an existent protocol...72  Delete an existent protocol ...72  Add a new protocol ...72  Modify an existing protocol ...74  Device manager ...75  Pair the K5 unit via Bluetooth ...76  User Accounts ...77  Change Password ...77  Users management (editing reserved to the Administrator only)...78  Roles management (editing reserved to the Administrator only)...80  Backup database (Standalone version only) ...81  Restore database (Standalone version only)...82  Backup and restore on server PC (Network version only) ...83 4

 Data import from CSV (option) ... 84  Before importing data... 84  Importing Data into OMNIA... 84  How to view Imported Data into OMNIA ... 84  Edit an Offline test ... 86  File description and field data structure ... 86  Resources Center ... 93  Event log ... 94 Calibration... 95  Introduction ... 96  Flow/volume calibration ... 96  Analyzer calibration

... 96

 Body Box calibration ... 96  Calibration frequency ... 97  Running the Calibration program ... 98  Flowmeter calibration ... 99  Setup ... 99  Calibration procedure ... 100  Flowmeter verification ... 102  X9 Linearization tables ... 104  Import existent linearization tables ... 104  Create new linearization tables ... 104  Gas calibration ... 106  Connections ... 106  Start the calibration panel... 106  The gas calibration ... 107  Body Box calibration ... 109  Leakage check... 110  Polytropic factor calibration ... 110  Mixing chamber calibration ... 112  Calibration database... 113  Printing a report ... 113  Control panel ... 115  Control panel for portable devices  Control panel for other devices

... 115 ... 116

Database management ... 117  Subject database ... 118  Subjects ... 119  Visits ... 123  Tests ... 127  Export and import data ... 128  Data filtering (for searching or printing) ... 129  Receiving data from the unit ... 131  Import data through the GDT protocol ... 133  Processing the GDT message ... 133

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Spirometry ... 137  General warnings ...138  Subject preparation ...138  Forced Vital Capacity (pre) ...139  Perform a FVC (pre) test...140  Pediatric incentive ...142  Slow Vital Capacity (pre) ...143  Perform a SVC test ...143  Maximum Voluntary Ventilation ...145  Perform a MVV test...145  Forced Vital Capacity post Bronchodilator ...147  Perform a FVC (postBD) test...147  Slow Vital Capacity post Bronchodilator ...149  Perform a SVC (post BD) test...149  Test editing ...151  Graphs ...152  QC and notes ...152  Results...153  Trial editing ...155  Test results...156  Bronchochallenge ...158  Perform a Bronchochallenge test ...158  Test editing ...160  Test results ...164  Edit function ...165 Dosimeter ... 167  General warnings ...168  Preparation for tests ...168  Performing the test ...169 Lung Volumes ... 171  General warnings ...172  Patient preparation ...172  Multi-Breath Nitrogen Washout test ...173  Performing the test ...173  Trial editing ...175  Test editing ...175  Test results ...178  Single-Breath Nitrogen Washout test...180  Performing the test ...180  Trial editing ...182  Test editing ...182  Test results ...185 Lung Diffusing Capacity ... 187  General warnings ...188 6

 Patient preparation... 188  CO Diffusing Capacity (DLCO) Test ... 189  DLCO single breath (standard technique) ... 189  DLCO single breath test procedure ... 189  Perform a DLCO test single breath (standard method) ... 191  DLCO Intra Breath ... 192  Trial editing ... 194  Test editing ... 195  Test results... 197 Respiratory Mechanics ... 199  General warnings ... 200  Patient preparation... 200  The MIP/MEP test ... 201  Perform a MIP/MEP test ... 201  Test editing ... 201  Trial editing ... 204  Test results... 204  The P0.1 (Respiratory drive) test ... 206  Perform a P0.1 test ... 206  Test editing ... 207  Test results... 210 Airways resistance measurement ... 211  General warnings ... 212  Patient preparation... 212  The Airways Resistance measurement test ... 213  Perform a ROCC test... 213  The Airways Resistance measurement test post BD ... 215  Test execution... 215  Viewing and editing test results ... 216  Trial editing ... 216  Test editing ... 218  Test results... 220 Body Plethysmography ... 223  General warnings ... 224  Preparation for a test ... 224  Test execution - overview ... 226  Performing a test ... 226  TGV/Raw (pre) ... 227  TGV/Raw post Bronchodilator... 231  Test execution... 231  Simulated TGV ... 232  Test execution... 232  Limitations of the measurement method ... 233  Viewing and editing test results ... 234  Test editing ... 234 7

 Trial editing ...236  Capture editing...237  Test results ...239  Predicted values interpretation ...240  Check the test quality ...240  RAW Challenge ...242  Test execution ...242  Test editing ...244  Trial editing ...247  Capture editing...247  Test results ...248  Edit function ...249 Six Minute Walk Test ... 251  The Six Minute Walk Test ...252  Overview ...252  Test editing ...252  Trial editing ...253  Test results ...254 Exercise testing ... 255  Recommendations for exercise testing ...256  Evaluation of the cardiorespiratory function ...256  Precautions ...256  Preparing the patient ...256  Measured parameters ...257  Preparing the device and the patient ...259  Performing the test ...260  Starting the test ...260  Execution of the test (real time visualization) ...261  Ending the test ...264  Editing the test ...265  Overview tab ...265  VO2 Max tab ...269  Thresholds tab ...270  VE Response tab ...271  VO2/WR - O2 pulse tab ...272  EFVL tab ...273  Interpretation tab ...275  Viewing the results ...276  Results tab...276  EFVL tab ...277  Dashboards tab ...278  Interpretation tab ...279 Resting Energy Expenditure Test ... 281  Metabolism...282  Total Metabolic Rate...282 8

 Resting Energy Expenditure (REE) ... 282  Importance of measuring REE ... 282  Measuring Resting Energy Expenditure with Indirect Calorimetry ... 282  Recommendations for performing a REE measurement ... 283  General recommendations ... 283  Resting Energy Expenditure test using a Canopy ... 283  Resting Energy Expenditure test on mechanically ventilated patients ... 284  Measured parameters... 285  The test with mask ... 286  Calibrations... 286  Preparing the patient ... 286  The test with mouthpiece ... 287  Calibrations... 287  Preparing the patient ... 287  The test with Canopy ... 288  Calibrations... 288  Preparing the canopy

... 288

 Preparing the canopy ... 289  Preparing the patient ... 289  The test on mechanically ventilated patients ... 291  Measuring principles - tests with turbine flowmeter ... 291  Calibrations... 292  Preliminary operations - using Quark RMR with turbine... 292  Preliminary operations - using Quark RMR with Flow-Ree ... 293  Limitations to the measurements ... 294  Performing a Resting Energy Expenditure test ... 295  Starting the test ... 295  Bias flow detection (test on mechanically ventilated patients only - turbine flowmeter only) ... 296  Execution of the test (real time visualization) ... 296  Ending the test ... 300  Editing the test ... 301  Overview tab... 301  Edit AVG REE tab ... 304  Interpretation tab ... 305  Viewing the results... 306  Results tab ... 306  Dashboards tab ... 307  Interpretation tab ... 308 Sub-maximal Exercise Testing ... 309  Introduction ... 310  Pre-test screening ... 310  Sub-maximal exercise testing... 311  Sub-maximal exercise testing considerations... 311  Staffing ... 311  Test termination ... 311  Considerations for accuracy ... 313

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 Performing the test ...314  Example of a test protocol ...314 The mixing chamber ... 315  The mixing chamber ...316  Overview ...316  Two-way non rebreathing valve description ...316  Patient’s preparation ...316  Connecting the two-way non rebreathing valve to the mask ...317  Connecting the above assembly to the head support (option) ...317  Preparing the mixing chamber for a test...317  Performing the test ...318

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 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: describes user interface. Settings: describes where to access custom settings. Utilities: describes 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.). Dosimeter: how to use the dosimeter function for broncho-provocation tests. Lung Volumes: how to perform Multi-Breath and Single-Breath Nitrogen Washout tests. Lung Diffusing Capacity: how to perform DLCO tests. Respiratory Mechanics: how to perform MIP/MEP and P0.1 tests. Airways resistance measurement: how to perform Rocc tests. Body Plethysmography: how to perform body plethysmography tests (Raw and TGV). Six Minute Walk Test: how to view a Six Minute Walk Test. Exercise testing. Explains how to conduct exercise testing, view results and edit data. Resting Energy Expenditure. Describes the Resting Energy Expenditure testing (REE) procedure. Describes viewing and editing test results. Sub-maximal testing. Introduces concepts for sub-maximal exercise testing, while integrating the exercise testing chapter. The mixing chamber. Describes the mixing chamber and the preparation for exercise and resting tests with the classic mixing chamber technique.

12 - Getting started - Overview of the manual

 Important Keynotes Below are important notes describing the organization of this manual. This will make the manual easier to follow.

 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

 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 Quark Spiro Quark PFT Quark CPET Quark RMR K4 b2 K5 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 compatible with the devices specified above. For all other COSMED devices please refer to Suite Software. 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 order to avoid archive corruption, compatibility problems and software crashes. Note: At this time, the compatibility with K4 b2 is limited to the test download feature. No real time testing is possible on K4 b2 with OMNIA software.

Getting started - Important Keynotes - 13

Installation

 Minimum System Requirements Intel Core i3 series processor or higher (Intel Core i5 recommended) • OS Stand-alone/Network Client: Windows 7 SP1, 8, 8.1, 10 (32 or 64 bit) OS Network Server: Windows Server 2008 SP2, 2008 R2 SP1, 2012, 2012 R2 • RAM 4GB (8GB recommended) • HD with 10GB of free space • Monitor with resolution of 1366x768 or greater (1920x1080 recommended) • CD/DVD drive (for installation) • A pdf reader software for opening the installed user manuals • Available USB port * • RS232 port available. If no RS232 port is available, an USB-to-Serial Adapter will be required (COSMED REF A-388-410-001) • For K5 units without the Bluetooth Long Distance module, a PC with internal Bluetooth or an external Bluetooth adapter will be required. Depending on the Operating System configuration, it may be necessary to install one or more of the following packages: • Windows Installer 4.5 (redistributable) • Microsoft Framework 4.6.2 (redistributable) • SQL Server 2014 SP1 Express (redistributable) • Microsoft SQL Server 2014 Shared Management Object • Microsoft SQL Server 2014 System CLR Types The above packages are included in the OMNIA installation CD/folder. They can also be downloaded from the Microsoft website at the below links: • http://www.microsoft.com/en-us/download/details.aspx?id=8483 (for Windows Installer 4.5) • http://www.microsoft.com/en-us/download/details.aspx?id=53345 (for Microsoft Framework 4.6.2) • http://www.microsoft.com/en-us/download/details.aspx?id=46694 (for SQL Server 2014 SP1 Express) • http://www.microsoft.com/en-us/download/details.aspx?id=42295 (for SQL Server 2014, all the items) * For devices with a dongle key, 2 USB ports are necessary (one for the dongle key, the other one for the device). •

Important note: In order to guarantee a proper and correct functioning of the software, and the safety and integrity of data stored into its database, we strongly recommend to use a PC optimized and dedicated exclusively to OMNIA. We furthermore strongly recommend to adequately protect the PC from viruses and other attacks from the Internet and/or local units.

16 - Installation - Minimum System Requirements

 Software installation  Introduction Note: If you are upgrading from an old OMNIA version, please create a backup of the database. OMNIA comes in two different versions: Standalone and Network. The first one can be installed on a standalone PC only, the second one can be used in a network environment (client/server). For the installation of the Network version, please refer to the Network manual distributed together with the Network version. Note: The installation of the Network version requires a local IT manager.

 General warnings and notes Important note: Due to a Microsoft SQL feature, the PC name and the Windows user name cannot be the same. If needed, either change one of those in order to perform the installation. Do not connect the COSMED device to the PC before installing the software. For devices with a dongle key, after installing the Omnia software and after 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). SQL Server installation can take several minutes (30 minutes or more, depending on the PC configuration). In case an OMNIA SQL Server instance has been already installed please contact the local IT department and ask SQL administrator credentials of the SQL instance where the OMNIA database will be installed.

 Installing the software (standalone installation) Note: The software is copyright protected and should only be installed from the original disk. 1. Please insert the OMNIA installation CD or run the executable file in the root directory of the installation package and select Install Omnia. 2. Follow the on-screen instructions to complete the installation. Note: if additional components (e.g. .net framework) are required, OMNIA will ask for installation of these components. 3. During the installation, the following dialog boxes will open:

Installation - Software installation - 17

4. 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:

You can select the following options: • install Omnia files (mandatory, to install the software) • install COSMED device drivers (mandatory, to use the COSMED devices with the software) 5. If the Windows UAC is activated and you are not logged as Administrator, enter the Administrator password when required by the software. Click Yes to confirm and proceed.

6. Wait until installation completes. 7. If you have the Suite software already installed, it is mandatory to perform the steps reported in the following section before using OMNIA in order to successfully complete the upgrade. Note: 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

18 - Installation - Software installation

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.

Installation - Software installation - 19

 Importing COSMED Suite archive into OMNIA Note: For the Network version, please refer to the corresponding section on the OMNIA Network User Manual. Note: Archives can only be imported from Suite Software version 10.0 and higher. In order to upgrade from COSMED Suite (version 10.0 or higher) to OMNIA, follow the instructions below. Please contact COSMED Support for Suite versions earlier than 10.0. 1. Connect the COSMED device to the PC and download the tests to the Suite Software (please refer to the Suite Software user manual). 2. Perform a backup of the archive in the Suite Software (please refer to the Suite Software user manual). 3. Close the Suite Software. Important note: The Suite Software and the OMNIA Software are not compatible. DO NOT USE the Suite Software anymore after this step. 4. If necessary, copy the Suite Software installation folder to the same PC where OMNIA has been installed. 5. Please insert the OMNIA installation CD or run the executable file in the root directory of the installation package and select Install DB Converter. Note: Install the COSMED_DB_Converter program only after the Omnia Software installation, otherwise it won't work. 6. Follow the on-screen instructions to complete the installation. 7. If the Windows UAC is activated and you are not logged as Administrator, enter the Administrator user name and password.

8. Wait until installation completes. 9. Start the COSMED_DB_Converter program by clicking on the Windows Start menu and selecting COSMED/COSMED_DB_Converter/ COSMED_DB_Converter.

20 - Installation - Importing COSMED Suite archive into OMNIA

10. Press Folder… to select which archive you would like to convert. 11. Browse the folder containing the Suite Software and press OK.

12. Select the tests to be converted and press Next, then START to start the conversion.

Installation - Importing COSMED Suite archive into OMNIA - 21

13. To stop conversion, press Exit during the process, otherwise wait for the end of the operation and press Exit to complete. Note: if the operation is stopped before the end, when the same conversion is launched for the second time, the tests already converted are automatically skipped. 14. Start OMNIA and make sure the archive has been successfully converted. 15. In order to avoid fatal errors, we strongly recommend to uninstall the Suite software by deleting the installation directory.

22 - Installation - Importing COSMED Suite archive into OMNIA

 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.

 The Domain - an introduction OMNIA users must be authenticated before accessing the software. A local domain or the network domain (if available) can be chosen in the authentication mask. If the local domain is chosen, the user must enter the username and the password stored in the OMNIA database, if the network domain is chosen, the user must enter the network username and password.

 Running the software for the very first time only - ADMINISTRATOR ONLY Note: This section is reserved for the first access to the software by the Administrator, just after the installation or after resetting the password. 1. 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: Network version does not require the USB dongle key 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). 2. Open the Windows Start menu and select COSMED/Cosmed Omnia/Cosmed Omnia or press the Cosmed Omnia icon on the PC desktop.

3. Type the User Name admin and the password admin. Press OK. Note: For this first time, please keep <Omnia> in the Domain field.

4. A new dialog box will appear, 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 of this new password. Press OK.

Installation - Open and close the software - 23