Omnia RM en 15.0

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Software Solutions

Reference Manual
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This manual has been written to the best of COSMED’s knowledge and in accordance
with the state of the art.
However, this does not exclude the possibility of errors or inaccuracies.
The images shown in this manual are for illustration purposes only and may not be an
exact representation of the product or its parts.
COSMED assumes no liability for the end user interpretation of this manual or for
casual or consequential damages from 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.
This manual has been written in accordance with IEC 60601-1 and IEC 82079 standards.

All trademarks, registered trademarks and logos mentioned in this reference manual
are property of their respective owners.

Read this reference manual carefully before using the device.


Keep this reference manual in a safe place for future reference.

OMNIA Reference manual, Edition 15.0 (07/2022)


REF C04144-02-91, English edition
Applicable from:
software version 2.2

Copyright © 2022 COSMED


COSMED

www.cosmed.com

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Table of Contents

1 - Get Started ............................................................................... 13


1.1 Manual Information ....................................................................................14
1.1.1 Reference manual’s publishing details and edition history ..................... 14
1.1.2 Manual purpose ....................................................................................... 14
1.1.3 Symbols used in this manual.................................................................... 15
1.1.4 Intended audience ................................................................................... 15
1.1.5 Related documents .................................................................................. 15
1.2 Important Notices .......................................................................................16
1.2.1 Indications for Use ................................................................................... 16
1.2.2 Warnings .................................................................................................. 16
1.2.3 Precautions .............................................................................................. 16
1.2.4 Security Information ................................................................................ 16
1.2.5 Cyber Security Requirements and Controls ............................................. 17
1.2.6 Software Upgrade Security ...................................................................... 18
1.2.7 Glossary of Symbols ................................................................................. 18
1.3 OMNIA Overview ........................................................................................19
1.4 OMNIA Modules .........................................................................................21
2 - Installation ............................................................................... 25
2.1 PC Requirements .........................................................................................26
2.2 Software Installation ...................................................................................27
2.3 Software and Hardware Activation .............................................................28
2.3.1 First Login ................................................................................................. 29
3 - Operating OMNIA ..................................................................... 31
3.1 Overview .....................................................................................................32

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3.1.1 Keyboard Commands ............................................................................... 32


3.2 Operating Areas .......................................................................................... 33
3.2.1 Top bar ..................................................................................................... 33
3.2.2 Central area .............................................................................................. 34
3.2.3 Bottom bar ............................................................................................... 35
4 - Settings .................................................................................... 37
4.1 Overview .................................................................................................... 38
4.2 International ............................................................................................... 39
4.3 Environment ............................................................................................... 40
4.4 Calibration .................................................................................................. 41
4.4.1 Flowmeter ................................................................................................ 41
4.4.2 Gas Analyzers ........................................................................................... 41
4.4.3 Body Composition .................................................................................... 41
4.4.4 Respiratory Mechanics ............................................................................. 42
4.5 QC ............................................................................................................... 43
4.5.1 Flowmeter ................................................................................................ 43
4.5.2 Body Box ................................................................................................... 43
4.5.3 Respiratory Mechanics ............................................................................. 43
4.6 Predicteds ................................................................................................... 44
4.7 Tests ........................................................................................................... 46
4.7.1 Spirometry ................................................................................................ 46
4.7.2 DLCO ......................................................................................................... 46
4.7.3 Body Plethysmography............................................................................. 49
4.7.4 Nitrogen Washout .................................................................................... 51
4.7.5 CPET .......................................................................................................... 52
4.7.6 REE ............................................................................................................ 53
4.7.7 Respiratory Mechanics ............................................................................. 55

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4.7.8 Pulse Oximetry ......................................................................................... 56


4.7.9 Post BD/BC ............................................................................................... 56
4.7.10 Advanced ............................................................................................... 57
4.8 ECG .............................................................................................................59
4.9 Admin .........................................................................................................60
4.10 Export .......................................................................................................62
4.10.1 File .......................................................................................................... 62
4.10.2 GDT ........................................................................................................ 63
4.11 Licenses .....................................................................................................64
4.12 Appearance ...............................................................................................65
4.13 About ........................................................................................................66
5 - Database .................................................................................. 67
5.1 Overview .....................................................................................................68
5.2 Structure .....................................................................................................69
5.2.1 Side bar .................................................................................................... 69
5.2.2 Subjects card ............................................................................................ 70
5.2.3 Visit card .................................................................................................. 71
5.3 Database Subpanels and Windows .............................................................75
5.3.1 New Subject/Edit Subject ........................................................................ 75
5.3.2 New Visit/Edit Visit .................................................................................. 75
5.3.3 Download Test ......................................................................................... 75
5.3.4 Offline Test ............................................................................................... 77
5.3.5 Trend ........................................................................................................ 77
6 - Testing ..................................................................................... 79
6.1 Overview .....................................................................................................80
6.1.1 Real-time Interface .................................................................................. 81
6.1.2 Charts and tabular data ........................................................................... 82

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6.1.3 Visit Review .............................................................................................. 83


6.1.4 Trial Editing............................................................................................... 86
6.2 Spirometry .................................................................................................. 87
6.2.1 Test Overview ........................................................................................... 87
6.2.2 Real-time Interface ................................................................................... 87
6.2.3 Visit Review .............................................................................................. 92
6.2.4 Trial Edit ................................................................................................... 95
6.3 Diffusing Lung Capacity ............................................................................... 98
6.3.1 Test Overview ........................................................................................... 98
6.3.2 Real-time Interface ................................................................................... 98
6.3.3 Visit Review .............................................................................................. 99
6.3.4 Trial Edit ................................................................................................. 100
6.4 Body Plethysmography ............................................................................. 104
6.4.1 Test Overview ......................................................................................... 104
6.4.2 Real-time Interface ................................................................................. 104
6.4.3 Visit Review ............................................................................................ 106
6.4.4 Trial Edit ................................................................................................. 107
6.5 Nitrogen Washout .................................................................................... 110
6.5.1 Test Overview ......................................................................................... 110
6.5.2 Real-time Interface ................................................................................. 110
6.5.3 Visit Review ............................................................................................ 111
6.5.4 Trial Edit ................................................................................................. 112
6.6 Respiratory Mechanics ............................................................................. 115
6.6.1 Test Overview ......................................................................................... 115
6.6.2 Real-time Interface ................................................................................. 115
6.6.3 Visit Review ............................................................................................ 116
6.6.4 Trial Edit ................................................................................................. 118
6.7 6MWT ....................................................................................................... 121

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6.7.1 Test Overview ........................................................................................ 121


6.7.2 Visit Review ............................................................................................ 121
6.7.3 Trial Edit ................................................................................................. 121
6.8 Metabolic - CPET .......................................................................................123
6.8.1 Test Overview ........................................................................................ 123
6.8.2 Real-time Interface ................................................................................ 123
6.8.3 Visit Review ............................................................................................ 128
6.8.4 Trial Edit ................................................................................................. 131
6.9 Metabolic - REE .........................................................................................141
6.9.1 Test Overview ........................................................................................ 141
6.9.2 Real-time Interface ................................................................................ 141
6.9.3 Visit Review ............................................................................................ 143
6.9.4 Trial Edit ................................................................................................. 145
6.10 Pulse Oximetry ........................................................................................149
6.10.1 Test Overview ...................................................................................... 149
6.10.2 Real-time Interface .............................................................................. 149
6.10.3 Visit Review .......................................................................................... 153
6.10.4 Trial Edit ............................................................................................... 153
6.11 ECG .........................................................................................................157
6.11.1 Test Overview ...................................................................................... 157
6.11.2 Real-time Interface .............................................................................. 157
6.11.3 Visit Review .......................................................................................... 158
6.11.4 Trial Edit ............................................................................................... 158
6.12 Body Composition ...................................................................................159
6.12.1 Real-time Interface .............................................................................. 159
6.12.2 Visit Review .......................................................................................... 159
6.12.3 Trial Edit ............................................................................................... 160

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7 - Calibration ............................................................................. 161


7.1 Overview .................................................................................................. 162
7.1.1 Real-time Interface ................................................................................. 163
7.1.2 Calibration Results.................................................................................. 163
7.2 Flowmeter Calibration .............................................................................. 164
7.3 Calibrate Scale .......................................................................................... 165
7.4 X9 Linearization Tables ............................................................................. 166
7.5 Gas Calibration ......................................................................................... 169
7.6 Polytropic Factor....................................................................................... 170
7.7 Mixing Chamber Flowmeter Calibration ................................................... 171
7.8 I2m Calibration ......................................................................................... 172
7.9 Q-i2m Calibration ..................................................................................... 173
7.9.1 Q-i2m Characterization .......................................................................... 173
7.9.2 Q-i2m Calibration ................................................................................... 173
7.9.3 Q-i2m Filter Characterization ................................................................. 173
7.10 Calibration History .................................................................................. 174
8 - Quality Control....................................................................... 177
8.1 Overview .................................................................................................. 178
8.1.1 Real-time Interface ................................................................................. 179
8.2 Flowmeter Verification ............................................................................. 180
8.3 Leakage Check .......................................................................................... 181
8.4 Q-i2m Test Load ........................................................................................ 182
8.5 BOD POD QC ............................................................................................. 183
8.5.1 Scale Check ............................................................................................. 183
8.5.2 Autorun .................................................................................................. 184
8.5.3 Volume Check ......................................................................................... 185
8.5.4 Autorun-6X ............................................................................................. 185

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8.5.5 Practice Subject Measurements ............................................................ 186


8.5.6 Export QC ............................................................................................... 187
8.6 Control Panel ............................................................................................188
8.7 QC History .................................................................................................192
9 - Utility ..................................................................................... 193
9.1 Overview ...................................................................................................194
9.2 Customize .................................................................................................195
9.2.1 Customize Header .................................................................................. 195
9.2.2 Customize PFT ........................................................................................ 196
9.2.3 Customize CPET...................................................................................... 198
9.2.4 Customize REE........................................................................................ 206
9.2.5 Customize ADP ....................................................................................... 215
9.2.6 Customize Trends................................................................................... 217
9.3 Metabolic Protocols ..................................................................................221
9.3.1 Exercise Protocol .................................................................................... 222
9.3.2 Resting Protocol ..................................................................................... 224
9.4 Broncho-Challenge Protocols ....................................................................225
9.4.1 Protocol Modality .................................................................................. 226
9.5 Training Zones Protocols ...........................................................................227
9.6 Device Manager ........................................................................................229
9.6.1 Overview ................................................................................................ 229
9.6.2 Bluetooth® pairing ................................................................................. 230
9.7 User Accounts ...........................................................................................231
9.7.1 Change Password ................................................................................... 231
9.7.2 Users Management ................................................................................ 231
9.7.3 Roles Management ................................................................................ 232
9.8 Backup Database .......................................................................................236

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9.9 Restore Database...................................................................................... 237


9.10 Import Data from CSV ............................................................................. 238
9.11 Event Log ................................................................................................ 239
9.12 Audit Log ................................................................................................ 240
10 - Resource Center ................................................................... 241
10.1 Overview ................................................................................................ 242
11 - Maintenance ........................................................................ 243
11.1 Overview ................................................................................................ 244
11.2 Database Backup .................................................................................... 245
11.3 Software Upgrade ................................................................................... 246
11.4 Firmware Upgrade .................................................................................. 247
11.5 License Upgrade ...................................................................................... 248
11.5.1 Devices shipped with a license dongle ................................................. 248
11.5.2 Devices shipped without a license dongle ........................................... 248
11.5.3 License Manager .................................................................................. 248
11.6 Recovery procedures .............................................................................. 251
11.6.1 Reset Password .................................................................................... 251
11.6.2 Initialize Database ................................................................................ 251
12 - Troubleshooting ................................................................... 253
12.1 Miscellaneous Problems ......................................................................... 254
12.2 Error Messages and Notifications ........................................................... 255
12.3 Bluetooth® Troubleshooting ................................................................... 275
12.3.1 Check for pending Windows® software updates ................................. 275
12.3.2 If a BTA is used, be sure that internal Bluetooth® module is disabled . 275
12.3.3 Replace “CSR Bluetooth® Chip” drivers with “Generic Bluetooth®”
drivers ............................................................................................................. 275
12.3.4 Verify that Bluetooth® Drivers are Properly Installed .......................... 276

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12.3.5 Uninstall Paired Device ........................................................................ 276


12.3.6 Change the USB port ............................................................................ 277
12.3.7 Check for incompatible or conflicting processes ................................. 277
12.3.8 Disable Power Management options ................................................... 278
12.3.9 Wi-Fi Network Interference ................................................................. 278
13 - Appendix .............................................................................. 281
13.1 Glossary of Parameters ...........................................................................282
13.1.1 Spirometry ........................................................................................... 282
13.1.2 Diffusing Lung Capacity ........................................................................ 285
13.1.3 Body Plethysmography ........................................................................ 286
13.1.4 Nitrogen Washout................................................................................ 288
13.1.5 Respiratory Mechanics......................................................................... 289
13.1.6 6MWT .................................................................................................. 292
13.1.7 Metabolic ............................................................................................. 292
13.1.8 Pulse Oximetry ..................................................................................... 298
13.1.9 ECG ....................................................................................................... 299
13.1.11 Body Composition .............................................................................. 301
13.1.12 Offline test ......................................................................................... 301
13.2 Glossary of Predicted Sets .......................................................................302
13.2.1 Spirometry ........................................................................................... 302
13.2.2 DLCO .................................................................................................... 304
13.2.3 Body plethysmography ........................................................................ 306
13.2.4 Nitrogen Washout................................................................................ 307
13.2.5 Respiratory Mechanics (MIP/MEP) ...................................................... 307
13.2.6 Airways Resistance (Rocc) .................................................................... 308
13.2.7 Airways resistance (FOT) ...................................................................... 308
13.2.8 6MWT .................................................................................................. 309

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13.2.9 Resting Metabolism.............................................................................. 310


13.2.10 Exercise Testing (Clinical) ................................................................... 310
13.2.11 Exercise Testing (Healthy) .................................................................. 313
13.3 Guidelines for automatic interpretation ................................................. 314
13.3.1 Pulmonary function testing interpretation .......................................... 314
13.3.2 CPET interpretation .............................................................................. 314
13.4 Integrated Devices .................................................................................. 315
13.4.1 Oximeter............................................................................................... 315
13.4.2 PC ECG .................................................................................................. 316
13.4.3 TTL ECG ................................................................................................. 316
13.4.4 Mortara® .............................................................................................. 317
13.4.5 GE® Cardiosoft ...................................................................................... 317
13.4.6 Cardiolex® EC Sense ............................................................................. 320
13.4.7 Tango® .................................................................................................. 320
13.4.8 N-SenTec® DMS .................................................................................... 320
13.4.9 Radiometer® TCM5 .............................................................................. 321
13.4.10 PhysioFlow ......................................................................................... 321
13.5 COSMED DB Converter............................................................................ 322
13.6 Compatible Ergometers .......................................................................... 324
13.6.1 Standard Configuration ........................................................................ 324
13.6.2 Optional Configuration ......................................................................... 325
13.7 Other Information .................................................................................. 327
13.7.1 Manufacturer’s Information ................................................................ 327
13.7.2 Privacy Information .............................................................................. 327
13.8 References .............................................................................................. 328
13.9 Notes ...................................................................................................... 329

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1 - Get Started

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1.1 Manual Information

1.1.1 Reference manual’s publishing details and edition history


This OMNIA reference manual provides information to use the software named
OMNIA Standalone (REF C04990-02-39), OMNIA Network (REF C04180-02-11)
“OMNIA” or “software” refer to the product line and instructions which relate to
both the OMNIA Standalone and OMNIA Network; OMNIA Network hereinafter
refers to instructions and applications which only relate to OMNIA Network.
This reference manual is published by COSMED and may be revised or replaced by
COSMED at any time without prior notice. User should ensure to have the most
current applicable version of this reference manual; if in doubt, contact COSMED
support.
Nothing in this reference manual shall limit or restrict in any way COSMED’s right to
revise or otherwise change or modify the software described herein, without notice.
In the absence of an expressed, written agreement to the contrary, COSMED has no
obligation to furnish any such revisions, changes, or modifications to the owner or
user of the software described herein.
COSMED will make available on request specific documentation to assist the
authorized trained personnel to repair software malfunctioning considered
serviceable by COSMED.
Whenever the Manual is updated, edition changes.
Edition Changes from previous edition [Edition 14.0 Date
(11/2021)]
15.0 Updated the following sections: OMNIA July 2022
Modules, Settings, Structure, Database
Subpanels and Windows, Testing, Calibration,
Customize, Backup Database, Glossary of
Parameters, Glossary of Predicted Sets,
Integrated Devices

1.1.2 Manual purpose


The OMNIA reference manual provides information that users need for the effective
use of the software. It is important that all users using this software read and
understand all the information contained within.

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This reference manual describes OMNIA with the most complete configuration with
all available modules. Detailed descriptions on how to run tests are demanded to
the device user manual.

Note: This reference manual can be used in conjunction with the user manual of
the device intended to communicate with the software.

1.1.3 Symbols used in this manual


Symbol Description
Designates a hint or important explanation on referred topic.
Note:

Designates a potential hazard or situation which if not avoided could


WARNING:
result in death or serious injuries.

1.1.4 Intended audience


This reference manual is intended for users who install, use and maintain the
software.
Please refer to the device user manual to learn about all hazards and risks
associated with the device and to gain knowledge about the competences required
for each task.

Note: OMNIA users are assumed to be competent with the functions and risks
associated with the connected device.

1.1.5 Related documents


Depending on the system configuration, further instructions may be supplied with
the device.
OMNIA Network Reference Manual (REF C04520-02-91).
OMNIA Connector Installation and Operating Manual (REF C04597-01-91).

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1.2 Important Notices

1.2.1 Indications for Use


OMNIA is used in conjunction with one or multiple devices. Please refer to the
device user manual for specific Indications for Use.

1.2.2 Warnings
OMNIA is used in conjunction with one or multiple devices. Please refer to the
device user manual for specific Warnings.

1.2.3 Precautions
Make sure you follow the procedures and recommendations reported in
section 11 - Maintenance to ensure your data are protected and secured
and your system includes the latest available updates for highest
performance and data reliability.
Carefully read sections 1.2.4, 1.2.5 and 1.2.6 to understand your
responsibility on sensitive data protection.
OMNIA is used in conjunction with one or multiple devices. Please refer to
the device user manual for specific Precautions.

1.2.4 Security Information


Protecting Personal Information
Protecting personal health information is the primary component of any security
strategy. Each facility using the software must provide the protective means
necessary to safeguard personal information in accordance with country laws and
regulations, and consistent with the facility’s policies for managing this information.
Protection can only be achieved when a comprehensive, multi-layered strategy
(including policies, processes, and technologies) is implemented to protect both
information and systems from external and internal threats.
As per their indications for use, the devices connected to OMNIA operate in the
vicinity of subject and contain personal and sensitive subject data.
To ensure the subject safety and protect personal health information the security
concept should include:

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Physical security access measures - access to the software/device must be


limited to authorized users. It is essential that physical security measures
are considered to ensure that unauthorized users cannot gain access.
Operational security measures - for example, ensuring that subject data are
deleted after completing the measurement.
Procedural security measures - for example, assigning only staff with
specific roles the right to use the software/device.
In addition, any security concept must consider the local country laws and
regulations requirements.
Always consider data security aspects of the network topology and configuration
when connecting the device to a shared network through the OMNIA SW. Your
medical facility is responsible for the security of the network, where sensitive
subject data from the device may be transferred.
When a device is returned for repair, disposed of, or removed from your medical
facility for any reasons, always ensure that all subject data is removed from the
device.
Log files generated by the device are used for system troubleshooting and do not
contain protected health information.
About HIPAA Rules
If applicable, your facility’s security strategy should include the standards set forth
in the Health Insurance Portability and Accountability Act of 1996 (HIPAA),
introduced by the United States Department of Health and Human Services. You
should consider both the security and the privacy rules as well as the HITECH Act
when designing policies and procedures. For more information, please visit:
http://www.hhs.gov/ocr/privacy/
About the EU Directives
If applicable, your facility’s security strategy should include the practices set forth in
the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27
April 2016 on the protection of natural persons about the processing of personal
data and on the free movement of such data (General Data Protection Regulation),
and repealing Directive 95/46/EC.

1.2.5 Cyber Security Requirements and Controls


OMNIA can be installed on networked PC and connected to COSMED compatible
devices.

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As part of your security concept, you are responsible for establishing controls to
protect your network and any networked devices, including the PC where the
OMNIA SW is installed, against cyber security threats.
Network Cyber Security Measures
Only connect COSMED devices operated using OMNIA to networks which are
explicitly intended for that purpose.
If you connect the device to a network, it is highly recommended that you deploy
measures to protect the network against cyber security threats. This includes the
deployment of firewalls to limit remote access and antivirus protection of standard
computer systems.
Network Security Requirements
For managing risks in clinical network deployments, COSMED recommends that you
apply a formal process such as the IEC 80001 series of standards to address safety,
effectiveness, and data and system security.

1.2.6 Software Upgrade Security


OMNIA is completely designed and built by COSMED. There are no separate user-
updatable software components from other manufacturers.
COSMED authorized software upgrade for compatible COSMED devices, including
any potential cyber security update, are communicated via the Engineering Change
Notice Process which is a part of the COSMED Quality System. The availability of SW
upgrade is published on the COSMED web site, at www.cosmed.com/update.
See section 11.2 for software upgrade procedure.

1.2.7 Glossary of Symbols


Packaging
On OMNIA box, USB card or USB dongle when containing activation codes for a
specific device:
Indicates the manufacturer catalogue number so that the
medical device can be identified.
(ISO 15223-1, Clause 5.1.6)
Indicates the manufacturer’s serial number so that a specific
medical device can be identified.
(ISO 15223-1, Clause 5.1.7)

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1.3 OMNIA Overview

OMNIA is used in conjunction with many COSMED devices, from spirometers to lung
functions systems, from metabolic carts to body composition equipment.
COSMED devices can communicate with OMNIA via USB, RS-232 or Bluetooth®
connections.
OMNIA software allows the user to:
Calibrate the device.
Perform test.
Manage subject data.
Review and edit test results.
The table below lists all COSMED devices compatible with OMNIA; the software
communication type and available software features are listed for each device:

● Available; x Not Available

COSMED device Communication Calibrate Perform Manage Review


type device test subject and edit
data test
result
Quark PFT USB, RS-232 ● ● ● ●
REF C09072-02-99
Quark CPET O2 USB, RS-232 ● ● ● ●
Paramagnetic
REF C09073-02-99
Quark CPET O2 USB, RS-232 ● ● ● ●
GFC
REF C09073-01-99
Quark RMR USB, RS-232 ● ● ● ●
REF C09074-01-99
Quark Spiro USB, RS-232 ● ● ● ●
REF C09071-01-99
Q-Box USB, RS-232 ● ● ● ●
REF C09068-01-99

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Quark i2m RS-232 ● ● ● ●


REF C09010-01-99
K4b2 RS-232 x x ● ●
REF C09052-02-99
K5 USB, x ● ● ●
REF C09090-01-99 Bluetooth®
Q-NRG USB, x ● ● ●
REF C09092-01-99 Bluetooth®
Q-NRG+ USB, x ● ● ●
REF C09092-02-99 Bluetooth®
microQuark USB ● ● ● ●
REF C09061-01-99
Pony FX USB, RS-232 x ● ● ●
REF C09062-01-99
Pony FX MIP/MEP USB, RS-232 x ● ● ●
REF C09062-05-99
Spiropalm 6MWT USB, RS-232 x x ● ●
REF C09064-03-99
BOD POD GS USB ● ● ● ●
REF A-661-230-023
BOD POD GS-X USB ● ● ● ●
REF A-661-230-040

OMNIA Review-only Station (REF C04390-01-11) can be purchased when there is no


need to control devices; this OMNIA version only allows the management of subject
data, review and edit results of tests imported into the database.

Note: From this point on “Quark CPET” refers to instructions which relate to
Quark CPET O2 Paramagnetic and Quark CPET O2 GFC.

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1.4 OMNIA Modules

OMNIA software has a modular structure.


Basic functionalities such as managing subject data, review and edit test results are
enabled in the default configuration of the software. Additional functionalities are
enabled according to the device connected to the software and/or to the activated
modules.
Each COSMED device includes specific modules in its standard configuration.
Additional software modules can be purchased at any time expanding the software
functionality; additional hardware modules may also be necessary to use the extra
functionalities (see device user manual).
The table below lists all OMNIA modules and describes the main functionalities:
OMNIA Module Description Functionalities
Module Code
A-670-100-001 OMNIA Spirometry Module Perform Spirometry tests (Spiro line)
(Spiro line)
A-670-100-002 OMNIA Spirometry Module Perform Spirometry tests (Quark line)
(Quark line)
A-670-100-003 OMNIA Lung Volumes - Perform Body Plethysmography tests
TGV/RAW Module
A-670-100-004 OMNIA Lung Diffusing Perform Diffusing Lung Capacity tests
Capacity - DLCO Module
A-670-100-005 OMNIA Metabolic - CPET Perform Cardio-Pulmonary Exercise
Module tests (Breath-by-Breath and/or Mixing
Chamber modalities according to
device configuration)
A-670-100-006 OMNIA Metabolic - REE Perform Resting Energy Expenditure
Vent Module tests in Ventilator modality
A-670-100-007 OMNIA Network Available for OMNIA Network only.
Add one client to an existing OMNIA
network environment (OMNIA
Network by default has 5 clients
enabled)
A-670-100-008 OMNIA GDT Module Share data using GDT protocol

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Get Started COSMED Srl

A-670-100-009 OMNIA Competitive Data Import data from external database


Import (see section 13.5)
A-670-100-010 OMNIA Misc Ergometers Enable communication with particular
Drivers ergometer models (see section 13.6)
A-670-100-011 OMNIA, Forced Oscillation Perform Force Oscillation tests
Module
A-670-100-012 OMNIA Airway Resistance - Perform Airways Resistance ROCC tests
Rocc Module
A-670-100-028 OMNIA Connector Module Share data with the Hospital
(Network version) Information System (HIS). Please refer
C04550-02-11 OMNIA Connector Module to OMNIA Connector user manual
(Standalone version)
A-670-100-014 OMNIA Respiratory Perform Respiratory Mechanics tests
Mechanics (P01, MIP-MEP) (Maximum Pressure and Respiratory
Drive)
A-670-100-015 OMNIA Lung Volumes - Perform Nitrogen Washout tests
FRC/N2WO Module
A-670-100-016 OMNIA Metabolic - REE Perform Resting Energy Expenditure
Canopy Module tests in Canopy modality
A-670-100-022 OMNIA Metabolic - REE Perform Resting Energy Expenditure
Module Mask tests in Mask modality
A-670-100-023 OMNIA AUX Devices Enable communication with auxiliary
Integration devices (see section 13.4)
A-670-100-025 OMNIA ADP Bod Pod Perform Body Composition tests
Module
A-670-100-026 OMNIA ADP Bod Pod PAED Perform Body Composition tests with
Module Pediatric population
A-670-100-027 OMNIA ADP Bod Pod TGV Perform TGV measurements during
Module Body Composition tests
A-670-100-029 OMNIA Walking Perform Pulse Oximetry tests
tests/Titration

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COSMED Srl Get Started

The table below lists all OMNIA modules indicating the compatible devices:

● Standard; ○ Optional; x Not Available

Compatible

Pony FX MIP/MEP
Spiropalm 6MWT
Device

BOD POD GS-X


BOD POD GS
microQuark
Quark Spiro
Quark CPET

Quark RMR

Quark i2m
Quark PFT

Q-NRG+

Pony FX
Q-NRG
Module

Q-Box

K4b2
Code

K5
A-670-100-001 x x x x x x x x x x ● ● ● x x x
A-670-100-002 ● ○ ○ ● x ● x x x x x x x x x x
A-670-100-003 ○ x x x x ● x x x x x x x x x x
A-670-100-004 ○ x x x x ○ x x x x x x x x x x
A-670-100-005 ○ ● ○ x x x x ● x x x x x x x x
A-670-100-006 x x ○ x x x x x x ○ x x x x x x
A-670-100-007 ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○
A-670-100-008 ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○
A-670-100-009 ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○
A-670-100-010 ○ ○ ○ x x x x ○ x x x x x x x x
A-670-100-011 ○ x x ○ ● ○ x x x x x x x x x x
A-670-100-012 ○ x x ○ x ○ x x x x x x x x x x
A-670-100-014 ○ x x x x ● x x x x x x x x x x
A-670-100-015 ○ x x x x x x x x x x x x x x x
A-670-100-016 x x ● x x x x x ○ ○ x x x x x x
A-670-100-022 ○ ● ● x x x x ● ○ ○ x x x x x x
A-670-100-023 ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○
A-670-100-025 x x x x x x x x x x x x x x ● ●
A-670-100-026 x x x x x x x x x x x x x x ○ ○
A-670-100-027 x x x x x x x x x x x x x x ○ ○
A-670-100-028 ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○
A-670-100-029 ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○

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Get Started COSMED Srl

C04550-02-11 ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○

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2 - Installation

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Installation COSMED Srl

2.1 PC Requirements

Note: For OMNIA Network additional requirements apply. Please refer to OMNIA
Network Reference Manual (see section 1.1.5).

Component Minimum Requirements


OS compatibility Windows® 8.x (32-bit, 64-bit), Windows® 10 (32-bit, 64-bit),
Windows® 11 (64-bit)
CPU speed 2 GHz or greater
RAM size 4 GB or greater (8 GB recommended)
Disk space 10 GB available for full installation (SSD recommended)
Database size 10 GB maximum dimension with SQL Express Edition (free).
Unlimited with SQL Standard Edition (license to be purchased
separately)
Monitor resolution Screen resolution 1366x768 or greater (1920x1080 recommended)
Ports USB (>2 recommended)
RS-232 (for ergometers remote control)
Database SQL Express Edition supplied (version 2014 for x86 OS, version
(Microsoft® SQL 2016 for x64 OS); version 2019 compatible
Server)

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COSMED Srl Installation

2.2 Software Installation

Note: The following installation instructions are applicable to OMNIA Standalone


only. For OMNIA Network installation, please refer to OMNIA Network
Reference Manual (see section 1.1.5)

Insert the OMNIA installation CD/USB drive.


Run the executable “setup.exe” file located in the “Omnia” folder.
The files directly distributed by COSMED are virus-free, any prompt on
suspicious file at this stage can be ignored.
Follow the on-screen instructions to complete the installation.
If additional components (e.g. .NET framework) are required, OMNIA will
prompt you to install the required components.
After the installation is successful, OMNIA icon will be added in the
Windows® Start Menu and in the desktop.

Note: The software is copyright protected and should only be installed from the
original CD/USB device.

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Installation COSMED Srl

2.3 Software and Hardware Activation

Depending on the device you want to connect to OMNIA, the software and
hardware activation codes reside on a USB dongle or in the device itself.

Pony FX MIP/MEP *
Device

Spiropalm 6MWT *

BOD POD GS-X


microQuark *

BOD POD GS
Quark Spiro
Quark CPET

Quark RMR

Quark i2m
Quark PFT

Pony FX *
License

Q-NRG+
Q-NRG
Q-Box

Type K4b2

K5
USB
● ● ● ● ● ● ● ● ●
dongle

Onboard ● ● ● ● ● ● ●

* USB dongle for devices which have been upgraded to OMNIA software from
previous Suite software.

Note: All non-COSMED devices require a USB dongle if not used as auxiliary
devices.

Devices with USB dongle license


As soon as OMNIA has been installed successfully:
Connect the USB dongle to the PC.
Power on the device and connect it to the PC.
Run OMNIA and login (see section 2.3.1).

Note: Each dongle is associated with a specific device SN (printed on the dongle
label) and only works with that device.

Devices with onboard license


OMNIA must be authorized the very first time by connecting the device to PC via
cable. As soon as OMNIA has successfully been installed:

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COSMED Srl Installation

Power on the device and connect it to the PC via the available wired
connection (see section 1.3). The necessary drivers for communication will
be installed automatically by Windows®.
Run OMNIA and login (see section 2.3.1)
Authorization lasts 30 days and needs to be renewed if an authorized device has not
been connected during that period. OMNIA can be re-authorized only via a wired
communication.

2.3.1 First Login


For the first login, enter the following credentials:
User Name: admin
Password: admin
Domain: Omnia (this field may not be enabled based on your PC
configuration).
Once logged in, it is requested to create a new password.
A status bar will indicate the complexity of the password you are trying to create,
the minimum default requirement is length ≥6 characters. To set new password
rules refer to section 4.9.

Note: Carefully store the password in a safe place. See section 11.6.1 to reset the
password.

At this stage you are logged in as OMNIA Administrator and you can create and
configure users and user roles, see section 9.6.
First User login (Domain: Omnia)
Users must leave the password field blank to be redirected to the page where to set
their own password.
First User login (Active Directory Domain)
Users must use their usual domain password.

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COSMED Srl Operating OMNIA

3 - Operating OMNIA

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Operating OMNIA COSMED Srl

3.1 Overview

OMNIA user interface is based on a hierarchical structure. The software panels are
structured as a series of encapsulated boxes and, as a general rule, the functions
located inside the larger box have effects on the smaller ones.
For each panel, tiles and buttons are displayed according to the devices connected
to the software and the existence of any additional modules. This reference manual
describes OMNIA with the most complete configuration.
The user interface for each specific software section is carefully described in the
following chapters.

3.1.1 Keyboard Commands


OMNIA software can be operated using a standard keyboard and mouse or,
whenever available, using a touch screen LCD.
Keyboard shortcuts are available for the most used functions:
Key Function
Enter Confirm the active field/button
Tab Skip to next field/button
Esc Return to the previous screen
F1 Open manuals folder
F2 Go to Home panel
F3 Insert marker (Metabolic and Pulse Oximetry tests)
F4 Insert ABG marker (Metabolic tests)
F5 Start testing
F6 Stop testing
F7 Redo (Lung Function tests)/Recovery (Metabolic tests)
F8 Abort
F11 Lap counter (Pulse Oximetry tests)

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COSMED Srl Operating OMNIA

3.2 Operating Areas

When navigating through the software the screen is divided in three main areas:

A Top bar B Central area C Bottom bar

The main features of each area are described below. Certain features may only be
available in certain software sections or configurations.

3.2.1 Top bar


The top bar is populated with:
Icons/Buttons Description
BACK button

Icon and title of the active


page

Active subject’s main


information

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Operating OMNIA COSMED Srl

Minimize

Resize

Close

3.2.2 Central area


The central area is populated with tiles and can include more than one page
(whenever more than 6 tiles are available). In this case the following icons are
available:
Icons/Buttons Description
Active page

Navigate through central


area pages

When a tile is clicked, the corresponding software function opens and a new panel
populates the central area. All software panels are carefully described within this
reference manual.
Some tile may lead to other tiles in accordance with the hierarchical structure of the
software.
Home panel
The central area of the Home panel is populated as follows:

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COSMED Srl Operating OMNIA

Database

Testing

Calibration
HOME
Quality Control

Utility

Resource Center

Functionalities and features of each tile of the Home panel are carefully described in
the following chapters of this reference manual.

3.2.3 Bottom bar


The bottom bar is populated with:
Icons/Buttons Description
Go to Home panel

OMNIA version

Open Settings panel (see section 4 - Settings)

Open the Support request form (internet connection required)

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Operating OMNIA COSMED Srl

Open devices user manuals and OMNIA reference manual folder

User logout

Get notifications from OMNIA Connector Worklist Manager.


Open OMNIA Connector Worklist Manager

Get GDT notifications

Get network status notifications (OMNIA Network only)

Browse RSS feed notification.


Used by COSMED to communicate software upgrade availability
or device news.
Open touchscreen keyboard

USB connection established with device

The Bottom bar is hidden when entering software sections.

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4 - Settings

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Settings COSMED Srl

4.1 Overview

Settings functions are accessible by clicking on OMNIA bottom bar (refer to


section 3.2). Refer to the diagram below (with the complete list of settings) to
access the required function. Settings functions visibility may depend to the rights
granted to the logged-in user.
International

Environment

Calibration

QC

Predicteds

Tests
Settings
ECG

Admin

Export

Licenses

Appearances

About

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COSMED Srl Settings

4.2 International
Settings Description
Language Select OMNIA language from the dropdown
Use HL7®-compatible Genders Check to enable the use of HL7® compatible genders.
HL7® genders include: Female, Male, Transgender,
Hermaphrodite/Undetermined, Other
Unit of Measurement Customize the unit of measurement for each
parameter

Note: Changes related to languages and unit of measurement are applied only
after restarting the software.

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Settings COSMED Srl

4.3 Environment

Environment
Settings Description
Temperature Enter the environmental temperature
Pressure Enter the barometric pressure
RH Enter the environmental relative humidity

Note: Device integrated sensors will overwrite the above default values at test
start and adjust the parameters above throughout the test.

Flowmeter
Settings Description
Enter the temperature at the flowmeter (default
Temperature
34°C)
Enter the relative humidity at the flowmeter (default
RH
100%)

BTPS
Settings Description
Apply Inspiratory BTPS Check to apply the BTPS correction factor during
Apply Expiratory BTPS Expiration / Inspiration

BTPS (Body Temperature and Pressure Saturated): an acronym indicating that a


volume of gas is reported as if it was saturated with water at body temperature and
ambient barometric pressure.
Location
Settings Description
Location Enter the installed location of the device

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COSMED Srl Settings

4.4 Calibration

4.4.1 Flowmeter
Syringe
Settings Description
Volume Enter the certified value of the calibration syringe
(default 3000 mL)

4.4.2 Gas Analyzers


DLCO Reference Gas
Settings Description
CH4, CO, O2 Enter the certified concentration of the DLCO gas
cylinder (default 0.3% CO, 0.3% CH4, 21% O2)

N2 Reference Gas
Settings Description
O2, CO2, O2 Enter the certified concentration of N2WO gas
cylinders (O2: default 16.0% , CO2: default 5.0%, O2
100%: default 100.0%)

ERGO/REE/ICU Reference Gas


Settings Description
O2, CO2 Enter the certified concentration of Metabolic gas
cylinder (O2: default 16.0%, CO2: default 5.0%)

O2 Span During Test


Settings Description
Ergo Configure maximum level for O2 sensor for Metabolic
tests (default 22%)
ICU Configure maximum level for O2 sensor for
ICU tests (default 70%)

4.4.3 Body Composition

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Settings COSMED Srl

Scale
Settings Description
Calibration Weight Enter the certified calibration weight for Scale
calibration procedure

Cylinders
Settings Description
Calibration Volume Enter the certified calibration Volume for Bod Pod
calibration (set by technician on installation)
Pediatric Calibration Volume Enter the certified Pediatric calibration Volume for
Bod Pod calibration (set by technician on installation)
Volume Phantom Value of an external Calibration Volume used to
calibrate Bod Pod (set by technician on installation).
Calibration Volume which was used for a previous
Bod Pod (GS, EX, etc.)

4.4.4 Respiratory Mechanics


FOT
Settings Description
R (hPa/L/s) Enter the certified calibration resistance value
(default 2 hPa/L/s)
Signal Level Enter the noise signal level for Quark i2m (default 40)

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4.5 QC

4.5.1 Flowmeter
Verification
Settings Description
Accepted Range Enter the acceptable range for the three flow ranges
(Low, Medium and High) used during Flowmeter
Verification
Max Error Enter the maximum acceptable error for Flowmeter
Verification

4.5.2 Body Box


Leakage Check
Settings Description
Target Pressure Enter the target pressure for Q-Box Leakage Check
(default 0.3 cmH20)

Simulated
Settings Description
Simulator Volume Enter the net Volume of the Q-Box simulator
System Resistance Enter the simulator Resistance
System Dead Space Enter the simulator Dead Space
Subject inside QBox during test Check when the simulated test is performed with a
subject inside the Q-Box (e.g. Erlenmeyer Flask
simulated test where the bulb is squeezed by a
Subject)

4.5.3 Respiratory Mechanics


FOT
Settings Description
Test load value Enter the certified test load value (Q-i2m only)

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Settings COSMED Srl

4.6 Predicteds

All predicted sets are grouped by test type and users can select the sets from the
dropdown for each test type. A link to the reference literature is provided by the
software for each predicted set (see section 13.2). The applicable area (age, gender,
height,…) of predicted sets is defined according to the corresponding reference.
Options
Settings Description
Show z score Check to display the z-score for each parameter
(number of SDs from predicted value) when available
in the predicted set
Show Post BD results as % of Check to display Post BD results as a % of predicted
predicted values rather than % of baseline results
Use Extrapolated Predicted Check to extend the predicted set if the subject falls
Values outside the reference range of the predicted set

Note: Not every predicted set can be extrapolated. When predicted data cannot
be extrapolated, the corresponding predicted values will remain blank if the
values are outside of the ranges of the predicted set.

Calculation Method
Settings Description
LLN/ULN Calc Select the guidelines for the calculation of Lower
Limit of Normal and Upper Limit of Normal:
80%-120% of predicted
ATS/ERS 2005 [1] (Pred ±1.645 SD)
Height from ulna length formula Select the formula for the calculation of height using
ulna length from the dropdown menu

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Hemoglobin Reference
Settings Description
Hb Ref. (Male) Enter the reference Hb level for Male population
(used in DLCO Hb correction, default 14.6 g/dL)
Hb Ref. (Female and Children) Enter the reference Hb level for Female and Children
population (used in DLCO Hb correction, default 13.4
g/dL)

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Settings COSMED Srl

4.7 Tests

4.7.1 Spirometry
General
Settings Description
Show QC Messages Show quality control messages according to ATS/ERS
2005 [2] or ATS/ERS 2019 [3] guidelines
Use breathing valve during Check when using the breathing valve during
spirometry spirometry to apply the correct calibration factors
Show calibration warning Check to show warning related to the necessity of daily
message calibration/verification
Start test immediately (Avoid Check to start the test immediately after selection from
pressing Start button) the Testing menu (removing the necessity to press the
Start button)

Charts
Settings Description
Autoscale F/V and V/t for small Check to auto scale the Flow/Volume and Volume/Time
curves curves: both axes are halved if curve points and related
predicteds are within the half of the standard range
Show entire FVC maneuver on Check to show the spirogram on V/t chart
V/t chart
Extend F/V loop scale up to 16 Check to extend the Flow axis up to 16 L/s
L/s
Show Normal Range on F/V Show standard deviation bars in correspondence of the
chart main predicted parameters (when available) on FVC
charts

4.7.2 DLCO
General
Settings Description
Show QC Messages Check to show quality control messages

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Chart
Settings Description
Show mouth pressure signal Check to show mouth pressure signal during DLCO
(DLCO SB) Single Breath (useful as quality control feedback during
breath-hold; aids the detection of unwanted Muller or
Valsalva maneuvers)
Auto-Refresh CO graph during Check to refresh the CO graph during editing, according
editing to the Zero Wet correction
Show CO/CH4 conc. vs volume Check to show CO/CH4 concentration curve against
volume (ATS/ERS 2017 [4])

Correction Factors
Settings Description
COHb/CO Back Pressure Select COHb/CO Back Pressure correction:
None
Zero Wet (use a correction on Hb for
“anaemia effect” in addition to the Zero Wet
for CO back pressure).
Formula (use a single formula based on
COHb% for both “anaemia effect” and CO
back pressure)
ATS 2017 [4] (use a formula based on FaCO
for “anaemia effect” and Zero Wet for CO
back pressure)

Breath-hold
Settings Description
Time Enter the duration of Breath-Hold
Method Select method to calculate the Breath-Hold:
Jones and Meade (from beginning of the
inspiration to the beginning of alveolar
sampling collection)
OGILVIE (from 30% of the inspiratory time to
the middle of alveolar sampling collection)
ESP (from 50% of inspiratory volume to the
beginning of alveolar sampling collection).

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Settings COSMED Srl

Washout Volume
Settings Description
Method Select method to identify Washout volume (and related
Sampling volume):
Automatic: from the end of Breath-Hold to
Sampling (Sampling 500mL / 1000mL);
software automatically detects the flattening
of tracer gas curve and identify the start of
Sampling volume.
ATS/ERS 2005 [5]: 1000mL from the end of
Breath-Hold (Sampling 1000mL)
ATS/ERS 2017 [4]: end of Breath-Hold to
Sampling (Sampling 200mL); software
automatically detects the flattening of tracer
gas curve and identify the start of Sampling
volume.
CO Based: from end of Breath-Hold to
Sampling (Sampling 500mL); software
automatically detects the start of Sampling
Volume when the CO curve crosses the
regression line obtained considering the
points belonging to middle third of CO
concentration vs. volume

Calculation Method
Settings Description
Alveolar Volume Select method to calculate Alveolar Volume:
ATS/ERS 2005 [5]
Mass Balance (as per ATS/ERS 2017 [4])
Overall results Select method to calculate Overall results:
Average
ATS/ERS 2017 [4]
Anatomic dead space Select method to calculate Anatomic dead space:
ATS/ERS 2005 [5] (2,2mL·kg-1)
ATS/ERS 2017 [4] (2,2mL·kg-1 if BMI<30kg·m-2,
h2/189.4 if BMI≥30kg·m-2)
Fowler

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TLC(DLCO) for Obstructed Check to apply the TLC(DLCO) correction for Obstructed
Subject Subject according to: Correction of Single-Breath
Helium Lung Volumes in Patients With Airflow
Obstruction: Naresh M. Punjabi, MD; David Shade, BA;
and Robert A. Wise, MD, FCCP. CHEST 1998; 114:907–
918

4.7.3 Body Plethysmography


General
Settings Description
Thermal equilibrium lead time Enter the thermal equilibrium time at the beginning of
the test (default 60s)
Ventilation valve opening time Enter the ventilation valve opening time (to allow
extra-time for pressure equilibration; default 4s)
Shutter closing timeout Enter the timeout for shutter closure (default 3s)
Raw Algorithm Select method to calculate the Raw:
sR0.5 (regression between ±500mL/s)
sR0.2 (regression between ±200mL/s)
sRFmax (regression between Max flow
points)
Multi sRaw consecutive Enter the number of sRaw to be consecutively captured
captures when pressing the Multi sRaw button
Discard Outliers Check to automatically discard outliers in TGV captures

Calculation Method
Settings Description
sRaw Select method to calculate the sRaw:
Average
Median
FRC(Pleth) Select method to calculate the FRC(Pleth) if Custom
volumes calculation method is selected (see below):
Average
Median

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Settings COSMED Srl

ERV (Available if Lung volumes method 1 is selected, see


below). Select method to calculate the ERV if Custom
volumes calculation method is selected (see below):
Average
Max
TLC(Pleth) (Available if Lung volumes method 2 is selected, see
below). Select method to calculate the TLC(Pleth) if
Custom volumes calculation method is selected (see
below):
Average
Median
Max
Lung volumes Select method to calculate Lung Volume subdivision if
Custom volumes calculation method is selected (see
below):
RV=TLC-VC, ERV=FRC-RV
RV=FRC-ERV, TLC=RV+VC

Select volume calculation method for all tests in the archive from the following:
Settings Description
ATS Preferred FRC=average, ERV=average, RV=FRC-ERV, TLC=RV+VC
(ERV, FRC and VC are measured)
ATS Optional FRC=average, TLC=max, RV=TLC-VC, ERV=FRC-RV (TLC,
FRC and VC are measured)
Custom All settings related to volumes are available

A diagram teaches the operator about how to perform the maneuver (correct
sequence and way of breathing: quiet breathing followed by panting is only
required for TGV capture).

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4.7.4 Nitrogen Washout


General
Settings Description
Calculation Method Select method to calculate the results:
ATS/ERS (ERV is the average among VC trials)
AARC (ERV is the maximum among VC trials)
Vt Stability Threshold Select the threshold for Vt and end-expiratory lung
volume over the 30 seconds preceding the test
Show QC Messages Check to show quality control messages
Show calibration warning Check to show a warning message to trigger air
message calibration before test start

Multi-Breath
Settings Description
End Test Criteria (FetN2) Enter the FetN2 value for End of Test determination (at
least three consecutive breaths with this concentration
must be recorded)
Depth of breathing Check (and enter the range) to have visual feedback on
the depth of breathing (L) during test execution
Frequency Check (and enter the range) to have visual feedback on
the respiratory frequency (1/min) during test execution
FiN2 Enter the value of FiN2 (%) contained in the inspiratory
mixture (default 0%)

Single-Breath
Settings Description
Calculation Method Select the calculation method for Single Breath:
25%-75% (regression line between 25%-75%
of the expired volume)
V III (regression line related to the phase III
itself)

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4.7.5 CPET
General
Settings Description
Start recording after 2 minutes Check to automatically begin the recording of the test
after 2 minutes (if Rec is not pressed)
Print Stored ECG Check to automatically print the ECG
Subject Type Select the default Subject Type in the pre-test window
interface:
Clinical
Healthy
Dyspnea/Leg Pain Select the scale to be used for Dyspnea/Leg Pain
evaluation:
Borg Scale (6-20)
Modified Borg Scale (0-10)
Calculate MVV Enter the calculation method of MVV based on FEV1
Show calibration warning Check to show a warning message to trigger air
message calibration before test start

Data Filtering
Select how to filter data from the following:
Settings Description
None No filtering is applied
Time Average Filter is based on time average. Enter time (default 30s)
Smoothing Filter is based on steps smoothing. Number of steps can
be selected from 3 to 10
Rolling Time Average Filter is based on rolling time average (one data point
every 10 seconds representing average data over the
previous 30 seconds)

Accepted Range
Check to configure automatic filtering in order to ignore non-physiological data.
Settings Description
Vt Tidal Volume > Min. Enter Min
VO2 Min < Oxygen Uptake < Max. Enter Min and Max

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RF Min < Respiratory Frequency < Max. Enter Min and Max
RQ Min < Respiratory Quotient < Max. Enter Min and Max

Additional Analyses
Settings Description
Enable Training Zones Check to show the Training Zones tab in CPET Edit
panel
Enable FatMax Check to show the FatMax calculation in the Training
Zones tab in CPET Edit panel
Enable O2 Kinetics Check to show the O2 Kinetics tab in CPET Edit panel

4.7.6 REE
General
Settings Description
Show calibration warning Check to show a warning message to trigger air
message calibration before test start

Data Filtering
Select how to filter data from the following:
Settings Description
None No filtering is applied
Time Average Filter is based on time average. Enter time (default 30s)
Smoothing Filter is based on steps smoothing. Number of steps can
be selected from 3 to 10
Rolling Time Average Filter is based on rolling time average (one data point
every 10 seconds representing average data over the
previous 30 seconds)

Accepted Range
Check to configure automatic filtering to ignore non-physiological data.
Settings Description
VT Tidal Volume > Min. Enter Min
VO2 Min < Oxygen Uptake < Max. Enter Min and Max
RF Min < Respiratory Frequency < Max. Enter Min and Max

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Settings COSMED Srl

RQ Min < Respiratory Quotient < Max. Enter Min and Max

Canopy
Settings Description
Normal Range Enter the normal range for FeCO2 during test execution
(warning trigger)
Enable FiO2 reading Check (and enter) the reading of FiO2 during test
Temp, RH@Flowmeter Select method for calculating Temperature and RH at
the Flowmeter:
Automatic (sensor based)
Custom (enter the value)
Quark RMR blower adjustment Select the method for blower adjustment:
PC SW
Manual knob

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4.7.7 Respiratory Mechanics


General
Settings Description
Show QC Messages Check to show quality control messages

P0.1
Settings Description
Vt Stability Threshold Select the Vt required stability before activation
Modality Check and select the modality for the test:
Environment
O2
CO2

Rocc
Occlusion
Settings Description
Insp/Exp Select the configuration for the occlusion
Flow Threshold / Peak Select the Flow Threshold (and enter threshold value)
or Peak for the occlusion
Type Select the occurrence of the occlusion:
> (whenever the flow is above the threshold)
Random (randomically)
Manual (manually activated)

Back Extrapolation Algorithm


Settings Description
t0, t1, t2 Enter the timing for back extrapolation calculations

Calculation Method
Settings Description
Average/Median Select method to calculate the results:
Average
Median

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Settings COSMED Srl

FOT
Settings Description
Calculation Method Select method to calculate the results:
Average
Median
Coherence Threshold Enter the coherence threshold for trail analysis
Signal Level Enter the signal level for FOT perturbation for Quark
i2m (default 40)

4.7.8 Pulse Oximetry


General
Settings Description
Desaturation Threshold (%) Enter the SpO2 % desaturation threshold
T ΔSpO2 > (%) Enter % difference from the baseline SpO2 to calculate
the cumulative residence time (T ΔSpO2) above such
threshold
T SpO2 ≤ (%) Enter the SpO2 % threshold to calculate the SpO2
cumulative residence time (T SpO2) below such
threshold
Dyspnea/Leg Pain Select the scale to be used for Dyspnea/Leg Pain
evaluation:
Borg Scale (6-20)
Modified Borg Scale (0-10)

4.7.9 Post BD/BC


Post BD
Settings Description
Show waiting time warning Check to show waiting time for Post BD test (ATS 2019
[3])
Wait time Enter the waiting time for Post BD test

Broncho-Challenge
Settings Description

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Default Protocol Select the default protocol for BC tests from the list of
available protocols (refer to section 9.4)
Default Reference Select the default reference for BC test:
Diluent (if present in the protocol)
Pre (if present in the same visit)

Dosimeter

WARNING: Read carefully before using the device. Users are assumed to be
competent with the associated functions and risks.

Settings Description
Nebulizer Driving Pressure Enter the nebulizing driving pressure (used to check the
effective pressure error when nebulizing)
Nebulizer Output Enter the correct Nebulizer output based on the
Nebulizer used; it is used for the calculations in
broncho-provocation protocols (dosimeter mode)
Reference values:
REF C05118-01-10 (RESPIRONICS
SIDESTREAM):
Nebulizer Output = 0.35 mL/min
REF A-862-010-001 (DEVILBISS):
Nebulizer Output = 0.9 mL/min
Review broncho-challenge protocols based on the
nebulizer used
Accepted Pressure Error (%) Enter the maximum acceptable error for driving
pressure
Start Delay (ms) Enter the delay in activation of nebulizer when
triggered
Triggering Flowmeter Select Flowmeter used for triggering the nebulizer

4.7.10 Advanced
Anti-Bacterial Filter
Settings Description
Dead Space (VDf) Enter the Anti-Bacterial Filter dead space

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Settings COSMED Srl

Resistance Enter the Anti-Bacterial Filter resistance

Flowmeter
Settings Description
X9 system Dead Space (VDs) Enter the X9 Flowmeter dead space
Turbine system Dead Space Enter the Turbine dead space
(VDs)
Valve Dead Space (VDv) Enter the Breathing Valve dead space
Flow-REE system dead Space Enter the Flow-REE dead space

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4.8 ECG

This menu allows the configuration of the GE® Cardiosoft-CASE and Cardiolex® EC
Sense interface.
Settings Description
Data folder Select destination of GE® Cardiosoft-CASE/Cardiolex®
EC Sense data
PDF folder Select destination of GE® Cardiosoft-CASE/Cardiolex®
EC Sense PDF report
Executable Path Select the path to the executable file used in testing
mode 1 (refer to section 13.4.5) to automatically start
the program
Protocol Select Cardiosoft-CASE/Cardiolex® EC Sense
communication protocol with OMNIA from the
dropdown (see section 13.4.5)

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Settings COSMED Srl

4.9 Admin

This menu is visible only to users with Administrator rights.


General
Settings Description
Ask confirmation before closing Check to avoid closing OMNIA accidentally,
Omnia without for confirmation
Full Disclosure Audit (need space on Check to create a log entry for every access that
disk) alters the database contents
Enable RSS-feed Check to receive the RSS-feed from COSMED;
push notifications will be received from COSMED

and displayed as a badge on the icon

Login
Settings Description
Login session timeout Enter the timeout for user’s session (OMNIA will
require password entry after timeout is expired)
Automatic login authentication using Check to use automatic login authentication using
Active Directory Active Directory

Password Expiration
Settings Description
Password does not expire Select to remove the password expiration
Password expires in ## Days Select (and enter) the duration of the password
verification

Password Complexity
Settings Description
Policy Select the password policy:
None
Custom (enter length and select
characteristics checkboxes)

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Note: Strong passwords (frequent password update, password stored in a safe


place) and login session timeout are crucial for personal data protection.

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Settings COSMED Srl

4.10 Export

4.10.1 File
File Name Pattern
Settings Description
File Name Define a standardized filename format using the
available options

PDF
Settings Description
PDF path Select the location for PDF reports
Open PDF file after exporting Check for automatic PDF opening after exporting
Use Bullzip PDF printer Check to use Bullzip PDF to generate PDF (it can
be enabled only if Bullzip is installed on the PC)
Generate PDF/A Check to create the PDF in PDF/A standard
format

Geotag
Settings Description
Geotag Select the option for display of GPS data (K5)

XML
Settings Description
Encrypt Check to encrypt the XML file
Include test curves Check to include data related to the single curve
Deidentify subject data Check to deidentify subject data
Include parameters for each trial Check to include test parameters of each trial
(NIOSH) (according to NIOSH specs)
Parameters Select the parameters to be exported:
Results
Edit
Print
Any

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4.10.2 GDT
General
Settings Description
Enable Check to enable the GDT communication
protocols
Parameters Select which parameters are exported according
to the customization (Results, Edit, Print, Any)

Import Settings
Settings Description
Data Path Select the location for the file containing the
requests to process
File Name Enter the file name related to the requests
Delete file after import Check to delete file after importing

Export Settings
Settings Description
Data Path Select the location for the file containing the
results
File Name Enter a file name related to the response
PDF Path Select the location for PDF export

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Settings COSMED Srl

4.11 Licenses

This menu contains the list of all installed and activated OMNIA modules on the
connected device(s). See section 1.4 for further details.

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4.12 Appearance

Resolution
Settings Description
Scaling Slide to adjust the scaling factor for OMNIA
resolution

Startup Display
Settings Description
Open Omnia on Assign the display where OMNIA will open (when
multiple screens are available)

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Settings COSMED Srl

4.13 About

This menu contains a direct link to COSMED website and information about:
Software version.
Current user.
SQL Server.
Database Size.

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5 - Database

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Database COSMED Srl

5.1 Overview

The Database is accessible by clicking on the Database tile from the Home panel.
In the Database users can:
View subjects, visits and test information.
Create new subjects, visits and tests.
Delete subjects, visits and tests.
Edit subjects.
Access visits and test edit screens.
Print visits and tests report.
Access subjects trend analysis.
Query the database and print query.
Import subjects, visits and tests in xml proprietary format.
Download tests from portable COSMED devices.
Export subjects, visits and tests in proprietary xml format.

Note: Activities in the Database may be limited based on the roles assigned to the
current user.

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5.2 Structure

The Database panel structure is based on the following hierarchy:


Subjects
Visits
Tests
and is divided in three main areas:

A Side bar B Subject card C Visit card

The main features of each area are described below. Certain features may only be
available in certain database status or software configurations.

5.2.1 Side bar


The side bar includes action buttons which may relate or impact on subjects, visits
or tests.
The side bar is populated with the following buttons:

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Database COSMED Srl

Buttons Description
Create new subject (see section 5.3)

Import subject/visit/test in proprietary xml format

Download tests from COSMED portable devices (see section


5.3.3)

Query the database based on date, ID1, visit status, grouping,


order number, or type of test

Print all visits displayed by the active query.


Print list of subjects (including main data) displayed by the
active query

5.2.2 Subjects card


The subject card is populated with the list of existing subjects, displaying
demographic and identifiable information:
Last Name.
First Name.
Date of Birth (D.O.B).
Gender.
ID1.
ID2.
The list can be ordered based on any of the above parameters by clicking on the
corresponding column. A search bar is also available above the list to search for the
desired subject. A number to the top right of the Subjects card indicates the number
of subjects in the database or the results of a search query, if applied.
When a subject is selected, the corresponding line is highlighted, and the action
buttons appear at the end of the line:

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Buttons Description
Open the edit subject panel.
Refer to section 5.3 for the complete list of fields

Create a previous visit (date < present date) for the selected
subject. Only an Offline Test can be created for a previous visit
(see section 0)
Delete the selected subject

Add an existing visit to the selected subject card

Other action buttons related to the most common functions are available in the top
section of the subject card:
Buttons Description
Create new visit for the selected subject (see section 5.3.2)

Create new test for the selected subject (see section 6 - Testing)

Open the trend analysis for the selected subject (see section
5.3.5)

Export the selected subjects in proprietary xml format

Clear the database query

5.2.3 Visit card


The visit card is populated based on the subject selected from the subjects card. It
lists all performed visits for the selected subject showing basic information:
Date.
Status (see section 6.1.3).

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Database COSMED Srl

Type (of tests performed during the selected visit).


When a visit is selected the corresponding line is highlighted and the following
action buttons appear at the end of the line:
Buttons Description
Open the selected visit (see section 6.1.3)
The visit can also be opened by double-clicking on the
corresponding line
Print the selected visit.
Select tests and options (top/bottom position for Interpretation
and Notes) to Print/Export in PDF format

Export the selected visit in proprietary xml format

Add an Offline test to the selected visit (see section 0)

Delete the selected visit

Move the selected visit to a different subject card, as long as an


existing visit on the same date is not already available

From the visits card users can access each test performed during the selected visit:
Icons Description
Click to show the list of available tests within a visit

Click to hide the list of available tests within a visit

For each test, the following basic information is shown:


Time.
Type.
Details (when available).

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When a test is selected, the corresponding line is highlighted and the following
action buttons appear at the end of the line:

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Database COSMED Srl

Buttons Description
Open the selected test (see section 6.1.3).
The test can also be opened by double-clicking on the
corresponding line
Print the selected test.
Notes and Interpretation are not available for single test
printouts
Export the selected test

Delete the selected test

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5.3 Database Subpanels and Windows

From the Database panel users can access the subpanels and windows described
below.

5.3.1 New Subject/Edit Subject


The New Subject/Edit Subject window is divided into 3 tabs:
Tab Fields
General ID1, ID2, First Name, Middle Name, Last Name, Ethnic Group,
Date of Birth (D.O.B), Gender
Contacts Address, City, Zip Code, Country, Mobile Phone, Work Phone,
Home Phone, Fax Number, E-mail
Other Data Insurance Company, Insurance Number, Comments (free text
field)

Mandatory or incorrect fields are highlighted with a red frame.

5.3.2 New Visit/Edit Visit


The New Visit/Edit Visit window is divided into 3 tabs:
Tab Fields
General Age, Height, Height Estimated from (arm length or ulna length),
Weight, HR Max Pred, Order Number, Reason for Visit, Visit
Status, Physician, Operator, Lifestyle, Predicted Set
Smoker Smoker, Cig/Day, Tobacco, Smoking Years, Non-Smoking Years
Classification Grouping, Class 1, Class 2

Mandatory or incorrect fields are highlighted with a red frame.

5.3.3 Download Test


The Download Test panel allows the transfer of tests from a portable unit to the
OMNIA database.
The following buttons are available:

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Buttons Description
Read data from the connected device and show all tests stored
on the device

Read data from the oximeter and show all tests stored on the
device, after device selection from the dropdown

Erase all data stored on the oximeter

Merge two or more test performed in the same day into a single
test

Create a new subject in OMNIA database based on the


information contained in the selected test

Load the selected test to an existing subject (selected from


OMNIA database)

To the left side of the panel all tests stored on the connected device are listed,
including basic test information. The list can be populated by clicking on and can
be filtered by toggling the Select New Test Only button. The selected test can be
transferred into OMNIA database creating a new subject or b

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eing linked to an existing one. Tests on device and subjects in OMNIA database can
be browsed using the two dedicated search bars.

5.3.4 Offline Test


An Offline Test is intended to be a test performed with a device which cannot be
connected to OMNIA, including non-COSMED devices. The software allows the user
to manually enter the test results of such devices for a complete subject visit
interpretation.
The Offline Test panel is divided into different sections, each corresponding to a
different type of test and including the main parameters. A separate section is
dedicated to miscellaneous parameters. A free text box for Comments is available.

5.3.5 Trend
The trend panel displays the progression of selected parameters across the selected
visits of a subject. The trend appearance can be selected from the Configuration
dropdown (see section 9.2.6) and the visits time interval can be set in the Start and
End fields.

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6 - Testing

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6.1 Overview

Test functions are accessible by clicking on the Testing tile from the Home panel of
OMNIA after having created a visit. Refer to the diagram below (with the complete
list of testing functions) to access the required test.

Note: Testing functions visibility depends on software and hardware configuration


(refer to section 1.4).

Spirometry

Diffusing Lung Capacity

Body Plethysmography

Nitrogen Washout

Testing Respiratory Mechanics

Metabolic

Pulse Oximetry

ECG

Body Composition

Note: For information on hardware components required for Testing,


contraindications, warnings and recommendations please refer to the
device user manual.

Note: For appearance and algorithms applied to test results refer to section 4.7.

The following process shows an overview of the step-by-step procedure to conduct


a test.

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# Step Description
1 Required Items Collect the necessary items according to specific test as
indicated by your device user manual
2 Warm-up and Follow the recommended warm-up time as indicated
Calibrations by your device user manual
Perform periodic calibrations as needed
3 Data entry and Test Select existing subject from the database or create a
Selection new one.
Add a new visit for the current day, if not present (refer
to section 5 - Database ).
Select the Test from Testing menu
4 Test Set-up Set-up device and accessories according to your device
user manual
When ready, press Start to begin the test
5 Real-time execution Instruct the subject on how to perform the test.
Perform multiple trials, if necessary, then stop the test
or wait for automatic end
6 Edit trials (if necessary) Edit Trials: performed trials can be accepted/discarded
7 Visit Review Review test results and edit visit information (if
necessary)
8 Dispose and Cleaning Dispose of non-reusable items
Clean and disinfect reusable items according to the
instructions in the Cleaning and Disinfection user
manual

6.1.1 Real-time Interface


During test execution users can interact with the software via several functions
shown in real-time interfaces. Below is a list of possible buttons:

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Button Function
Start the test/activate gas delivery/start recording as
per defined in your device user manual

Zeroing of the PNT flowmeter sensor (only shown for


PNT)

Restart the current trial without saving

Stop data recording

Cancel the test (all the data will be lost)

Exit from real-time test interface

The bottom bar indicates if BTPS has been disabled from the Settings (refer to
section 4.3) for some pulmonary function tests. For test-specific functions please
refer to the sections below.

6.1.2 Charts and tabular data


A title bar indicating the plot title is shown on all charts that can be chosen
throughout the navigation. The following functions may also be visible on the charts
title bar:
Button Function
Select parameters to view on the chart. Standard graphs can be
selected or alternatively Edit Chart is available to customize the
graph (refer to sections 9.2.3 and 9.2.4 for further information)
Print chart

Set graph Y-scale according to VEmax (CPET only). Autoscale and


different VEmax values are available

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Maximize graph

Tabular data may also be seen throughout the navigation and during test execution.
Refer to section 9.2 for parameter selection.

6.1.3 Visit Review


The Visit Review panel allows the review of all tests performed during a visit. This
panel is displayed as soon as a test is stopped, however, it can also be accessed
anytime from the Database.
The Visit Review panel allows to switch between panels of all tests performed
within the visit, by clicking on the corresponding test tab in Visit Review upper bar.

Results which are displayed in Visit Review can be customized in Utility (refer to
section 9.2 for further details).
The following functions are available:
Button Function
Perform a new test in the current visit

Edit visit (General, Smoke and Classification information)

Manually insert offline test data

Select tests, visit (Compact PFT Report or Overview) and options


(top/bottom position for Interpretation and Notes) to print/export
as PDF

The compact PFT report is organized as follows: the header fields are in white
(complete or partial fields are shown depending on the report page, see section
9.2.1). Below the header, all PFT tests performed within the visit are shown in a
compact fashion: each test is preceded by a grey bar with some test-specific fields

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(including test type and details) and numerical results are shown for the Visit
Review Overview panel parameters. Charts are shown for each test except for MVV,
DLCO IB, MIP/MEP and Rocc. The interpretation is also shown according to the
selection. Below the compact test section, all tests selected in the print options are
shown in detail.
Additional details on test-specific visit review features are available for each test
described in this chapter.
Visit Review Overview
The Visit Review Overview panel contains information for all tests performed within
the selected visit, including the visit status. The Visit Review Overview panel
comprehends:
Numerical results and their normal ranges, predicted values and z-scores.
Interpretation and Notes.

Interpretation and Notes are editable by clicking on the corresponding tabs to the
right. Five visit statuses are available:
To be processed.
In progress.
Preliminary.
Final.
Corrected.

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The following functions are available:


Button Function
Run automatic interpretation according to guidelines in section
13.2.2

Browse comments from the Resources Center (refer to section 10 -


Resource Center) to add to the Interpretation or Notes (depending
on current open tab)
Visualize automatic interpretation for Metabolic tests performed
with software versions <2.0

Click to reduce font size

Click to increase font size

Visit Review test panel


Visit Review test panels contain the following sections:
Graphical results.
Numerical results and QC.
Interpretation and Notes (editable by clicking on Interpretation/Notes
bottom bar as described above).
The following functions are available for all Visit Review test panels:
Button Function
Perform New Trial within the current visit

Edit Trials

Print test

Export test (multiple formats may be available depending on the


test type)

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Review environmental conditions and BTPS factors applied during


test

Review flowmeter calibration factors

6.1.4 Trial Editing


Trial Editing functions are available by clicking on from the Visit Review panel.
Trial Edit panel shows the following trial-specific sections:
Graphical results.
Numerical results and QC.
Button Function
Review environmental conditions and BTPS factors applied during
test

Review flowmeter calibration factors

Restore the data to the last saved version

Additional details on test-specific trial editing functions are described in the


following sections in relation to each single test.

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6.2 Spirometry

6.2.1 Test Overview


OMNIA allows to perform several spirometry tests, as shown in the spirometry
testing menu below.

Forced Vital Capacity

Forced Vital Capacity Post Dilator

Slow Vital Capacity


Spirometry
Slow Vital Capacity Post Dilator

Maximum Voluntary Ventilation

Forced Vital Capacity Challenge

Common indication for Forced Vital Capacity Challenge is to diagnose hyper


responsive airways. Subjects with hyperreactive airways will demonstrate a
response with the inhalation of challenging agents with repeated FVC maneuvers
displaying signs of airways obstruction. Decrease in FEV1 is used to determine
presence and severity of bronchial hyperresponsiveness.

6.2.2 Real-time Interface


Forced Vital Capacity (pre/post BD)
During test execution the flow-volume graph and the volume-time graph are shown.
To the right, ATS/ERS [3] recommended EOFE (End of Forced Expiration) indicators
are indicated by vertical bars: FET (Forced Expiratory Time) and ∆Vol Last s (change
in volume during the last one second). FET should equal 15 seconds or alternatively
∆Vol Last s should be less than 0,025 L to ensure a true FVC has been reached.

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Pediatric Incentive
Pediatric incentive option is available, to help children perform acceptable FVC
and FVC post BD tests using animations and graphics. It is on by default if the
subject is ≤ 7 years. In any case, the incentive can be enabled/disabled for all
subjects by clicking on the Incentive button. OMNIA offers different animation
and configuration of both flow and volume targets, complying with ATS/ERS
2007 [6]. The following functions are available:
Button/slider Function
Enable/disable the pediatric incentive option and select the
desired animation by clicking on the corresponding button

Enable fish animation incentive

Enable airplane animation incentive

Allow to reach the animation target regardless of the


flow/volume targets

%PEF Pred Select flow target as a % of predicted PEF for goal achievement
(from 30% to 150%)
%FVC Pred Select volume target as a % of predicted FVC for goal
achievement (from 30% to 150%)

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Slow Vital Capacity (pre/post BD)


During test execution the volume-time graph is shown.
Maximum Voluntary Ventilation
During test execution the volume-time graph is shown.
Forced Vital Capacity Challenge
During test execution the Forced Vital Capacity real-time interface is shown.

WARNING: When a protocol step is repeated, the agent must not be


administered. The agent must be administered only if the selected step
is a new one.

WARNING: If FEV1 decreases more than 20% when compared to baseline FVC, as
the Trial Edit panel opens a message prompts indicating the target has
been reached. Please end the test as continuing can be dangerous and
is NOT recommended.

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Non-dosimeter protocols
After protocol selection, the below interface appears if the selected protocol is
not a Dosimeter Protocol (as defined in section 9.4). Users can modify the
protocol-specific feature (e.g. the agent dose) for the current protocol step. The
Test button shall be pressed after the provocation step has been performed to
execute the FVC maneuver, or alternatively Cancel is available to abort.

Button/Field Function
Skip to the next step

Go to previous step (disabled if previous step has already been


performed)
Skip to the last step of the protocol

Name of the agent to be delivered at the current step (as


Agent
defined in section 9.4)
Dose (mcg) Step agent dose (as defined in section 9.4)

Dosimeter protocols
If the selected protocol is a Dosimeter Protocol (as defined in section 9.4) the
dosimeter protocol interface below is shown. Users can modify the agent for
the current protocol step and navigate through the steps. The Stop button shall
be pressed after the provocation step has been performed to execute the FVC
maneuver, or alternatively Cancel is available to abort.

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Button/Field Function
Start the provocation step (it may include one or more
breaths, as per defined in the protocol)

Deliver the dose to the subject

Deliver an extra dose to the subject

Abort (without saving)

Terminate the step and open FVC real-time interface to


execute the maneuver

Skip to the next step

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Go to previous step (disabled if previous step has already been


performed)

Skip to the last step of the protocol

Concentration Step agent concentration (as defined in section 9.4)


Dose Step agent dose (as defined in section 9.4)
Actuation Step actuation time (as defined in section 9.4)
Cumulative Dose Step cumulative dose (as defined in section 9.4)
Agent Name of the agent to be delivered at the current step
Breaths Breath counter: shows the number of breaths performed
within the current step
Breath Dose Dose administered to the subject in the current breath
Step Dose Dose administered to the subject in the current step
Inhale Inhalation time
Nebulizer Nebulizer pressure
Σ Dose Cumulative dose administered to the subject

6.2.3 Visit Review


FVC
FVC panel allows to switch between all FVC tests performed (FVC, FVC post
BD, FVC post BC) by clicking on the corresponding tab to the right. FVC
Challenge test is indicated as FVC post BC.
FVC (pre/post BD)
In FVC Pre and Post BD panels, graphs (Flow-Volume and Volume-Time)
and numerical results show the best FVC inspiratory phase and the best
FVC expiratory phase among the trials performed (not necessarily from
the same trial). Results are reported as a percentage of the predicted
values and as z-scores, exceeding ATS/ERS recommendations [3].
Predicted values and normal ranges for each parameter are also
reported, according to the selected predicted set. Gauges which
graphically display z-scores of the main FVC parameters relative to normal
ranges and severity (%) are also shown for easy interpretation of the results.

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System quality control for FEV1 and FVC results is provided by OMNIA in
agreement with [3]. The software also displays the operator quality control and
subject position during the test, both of which are entered by the operator.
The following predicted values are shown on FVC graphs, if available:
MEF25%, MEF50%, MEF75%, PEF (horizontal line) and FVC on
Flow-Volume graph.
FEV1, FVC (horizontal line) and 6s line, as defined by ATS/ERS.
In addition to FVC Pre results, the dose of the administered BD agent is shown
in FVC Post BD panel. Graphs and numerical results show FVC Pre and Post
results.
FVC post BC
In FVC post BC panel, Flow-Volume and Volume-Time graphs and numerical
results at each protocol step show the best FVC inspiratory and expiratory
phases of performed trials within each step. A graph showing FEV1 fall at each
step is displayed and by clicking on users can either select a Fall % or a %
Baseline visualization. Numerical results include PD20, PD15 and PD10 and are
shown for each protocol step. Users can visualize either Dose or Cumulative
dose results by selecting the corresponding representation from the dropdown.

Note: If first dose (X) caused >20% decrease in FEV1, the dosage is listed as
<X. For all other steps, the dosage is calculated as an interpolation
between two steps, in accordance with ATS guidelines.

The following functions are available in addition to those described in section


6.1.3.
Button Function
Use FVC Pre or diluent as a reference for graphical and
numerical results (refer to section 4.7.8 to configure the
default reference)

SVC
SVC panel allows switching between all SVC tests performed (SVC, SVC post BD) by
clicking on the corresponding tab to the right.
In SVC Pre and Post BD panels, graphical and numerical results show the best SVC
maneuver among the trials performed, independently of the performed maneuver
(IVC or EVC). VC, IRV, VT and ERV are graphically displayed on SVC graph.

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Results are reported as a percentage of the predicted values and as z-scores,


exceeding ATS/ERS recommendations [3]. Predicted values and normal ranges for
each parameter are also reported, according to the selected predicted set. A gauge
of the VC z-score relative to the normal range is also shown for easy interpretation
of the results.
System quality control is provided by OMNIA in agreement with [3]. The software
also displays the operator quality control and subject position during the test, both
of which are entered by the operator.
MVV
In MVV panel, graphical and numerical results show the best MVV maneuver among
the trials performed.
Results are reported as a percentage of the predicted values and as z-scores,
exceeding ATS/ERS recommendations [3]. Predicted values and normal ranges for
each parameter are reported too, according to the selected predicted set. A gauge
of MVV z-score relative to the normal range is also shown for an easy interpretation
of results.
The software displays the operator quality control and subject position during the
test, both of which are entered by the operator.

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6.2.4 Trial Edit


FVC (pre/post BD)
In FVC Edit panel users can accept/discard trials, independently choose the best
expiratory and inspiratory phases among the performed trials and show/hide trials.
Users can also modify the Operator QC and Position fields. The following functions
are also available in addition to those described in section 6.1.4.
Button Function
Perform a new FVC trial

Accept all the trials

Automatically select the best trial according to ATS/ERS criteria

Accept only the three best trials according to ATS/ERS criteria

In FVC post BD Edit panel, the user can modify the BD agent dose administered
during the test.

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FVC Post BC
From FVC Post BC Visit Review panel, users can independently edit trials for each
step of the FVC Challenge, by clicking on the corresponding button. Users can
also modify the Operator QC and Position fields. The following functions are
available in addition to those in section 6.1.4.
Button Function
Perform a new trial for the current step

Accept all the trials for the current step

Automatically select the best trial according to ATS/ERS criteria for


the current step

Accept only the three best curves according to ATS/ERS criteria for
the current step

SVC (pre/post BD)


In SVC Edit panel user can accept/discard trials, choose the best SVC among the
performed trials and show/hide trials. The Operator QC and Position fields can be
modified. The following functions are available in addition to those in section 6.1.4.
Button Function
Perform a new SVC trial

Accept all SVC trials

Automatically select the best SVC trial according to ATS/ERS criteria

Accept only the three best SVC trials according to ATS/ERS criteria

Single SVC trials can also be edited after clicking on the corresponding icon.
EELV (black dashed horizontal line) and EILV (red dashed horizontal line) for the

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selected curve, which detect VT, can be adjusted graphically. Pressing OK changes
are confirmed (Cancel disregards them). VT and IC values beneath the graph are
automatically updated as soon as EELV and EILV values are adjusted.

In SVC post BD Edit panel, the administered BD agent dose can be modified.
MVV
In MVV Edit panel user can accept/discard trials, choose the best MVV among the
performed trials and show/hide trials. Users can modify the Operator QC and
Position fields. The following functions are available in addition to those in section
6.1.4.
Button Function
Perform a new MVV trial

Accept all MVV trials

Automatically select the best MVV trial according to ATS/ERS


criteria

Accept only the three best MVV trials according to ATS/ERS criteria

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6.3 Diffusing Lung Capacity

6.3.1 Test Overview


OMNIA allows to perform the Diffusing Lung Capacity tests shown in the menu
below.

Diffusing Lung Capacity (Single Breath)


Diffusing Lung
Capacity
Diffusing Lung Capacity (Intra Breath)

DLCO test consists in a diffusion gas maximal inspiration from RV to TLC, followed by
a breath-hold period and an exhalation (Single-Breath technique). Inspired and
exhaled CO and tracer gas are analysed to calculate the transfer factor.
As an alternative for subjects who lack the ability to hold their breath, the DLCO
Intra-Breath technique allows a slow exhalation to replace the breath-hold period.
OMNIA also allows to evaluate 𝐷𝑀 and 𝑉𝐶 for both techniques if at least two trials
are performed with different oxygen fractions in the inspired gas (Membrane
Diffusion test).

6.3.2 Real-time Interface


Diffusing Lung Capacity (Single Breath)
During test execution real-time volume and gas concentrations are displayed.
Diffusing Lung Capacity (Intra Breath)
During test execution real-time volume and gas concentrations are displayed.

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6.3.3 Visit Review


DLCO SB
DLCO SB Visit Review panel shows the results of the Diffusing Lung Capacity (Single
Breath) test. In the DLCO SB panel, charts (Volume, concentration and pressure vs
time and gas vs volume) and numerical results show the best DLCO from the trials
performed.
The volume graph plots CO and CH4 % concentrations, mouth pressure and volume
from the beginning of the maneuver. The breath-hold time from the calculation
method, the washout volume and sampling volume are also displayed on the graph
where a horizontal line indicates the volume corresponding to 90% of best VC
performed during the visit.
The gas vs. volume graph plots inhaled (dashed lines) and exhaled (solid lines) CO
and CH4 % concentrations against exhaled volume. The sampling volume is also
displayed.
Results are reported as percentage of the predicted values and as z-scores.
Predicted values and normal ranges for each parameter are also reported, according
to the selected predicted set. Gauges which graphically display z-scores of the main
DLCO parameters are also shown for easy interpretation of the results.
The software displays the operator quality control and subject position during the
test, both of which are entered by the operator. The following functions are
available in addition to those described in section 6.1.1.
Button Function
Review gas calibration factors

DLCO IB
DLCO IB Visit Review panel shows the results of the Diffusing Lung Capacity (Intra-
Breath) test. In the DLCO IB panel, the volume chart and numerical results show the
best DLCO from the trials performed.
The graph plots CO and CH4 % concentrations, the flow and volume from the
beginning of the maneuver and the recommended expiratory flow range (between
250 and 750 mL/s). The washout volume and sampling volume are displayed on the
graph where a horizontal line indicates the volume corresponding to 90% of best VC
performed during the visit.
Results are reported as a percentage of the predicted values and as z-scores.
Predicted values and normal ranges for each parameter are also reported, according

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to the selected predicted set. Gauges which graphically display z-scores of the main
DLCO parameters are also shown for easy interpretation of the results.
The software displays the system quality control, the operator quality control and
subject position during the test, both of which are entered by the operator. The
following functions are available in addition to those described in section 6.1.3.
Button Function
Review gas calibration factors

6.3.4 Trial Edit


DLCO SB
In DLCO SB Edit panel user can accept/discard trials, choose the best DLCO
maneuver from the trials performed and show/hide trials. Users can also modify the
Operator QC and Position fields and enter subject’s hemoglobin (Hb) and
carboxyhemoglobin (COHb) concentration values at test start (see section 4.7.2 for
further details). The following functions are also available in addition to those
described in section 6.1.4.
Button Function
Perform a new DLCO trial

Accept all the trials

Automatically select the best trial according to ATS/ERS criteria

Accept only the three best trials according to ATS/ERS criteria

Review last gas calibration

Single DLCO trials can also be edited after clicking on the corresponding icon.
The sampling volume and the washout volume can be adjusted by moving the two
red dashed lines directly on the graphs or by moving the sliders below the graphs.

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These volumes can also be adjusted according to standard methods which users can
select from the Washout Volume dropdown to the right. If the Mass Balance
calculation method is selected from OMNIA Settings (refer to section 4.7.2) an
additional slider allow to adjust the end of test. Users can also adjust the correction
factors by selecting the method for COHb and back pressure adjustment from the
dropdown and enable the TLC(DLCO) calculation for obstructed subjects by clicking
on the corresponding checkbox. Software also allows to enable membrane diffusion
which requires entering fraction of inspired oxygen %. To choose the breath-hold
method from the dropdown and to zoom in on the Volumes graph, toggle the
Magnifier button. For further details on DLCO options please refer to section 4.7.2.
Pressing OK, changes are confirmed (Cancel disregards them).

DLCO IB
In DLCO IB Edit panel user can accept/discard trials, choose the best DLCO
maneuver from the performed trials and show/hide trials. Users can also modify the
Operator QC and Position fields and enter subject’s hemoglobin (Hb) and
carboxyhemoglobin (COHb) concentration values at test start (see section 4.7.2 for
further details). The following functions are also available in addition to those
described in section 6.1.4.

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Button Function
Perform a new DLCO trial

Accept all the trials

Automatically select the best trial according to ATS/ERS criteria

Accept only the three best trials according to ATS/ERS criteria

Review last gas calibration

Single DLCO trials can be edited by clicking on the corresponding icon. The
sampling and washout volumes can be adjusted by moving the two red dashed lines
directly on the graph or by moving the sliders below it. These volumes can also be
adjusted according to ATS/ERS [4]. Users can adjust the correction factors by
selecting the method for COHb and back pressure adjustment from the dropdown
and enable the TLC(DLCO) calculation for obstructed subjects by selecting the
corresponding checkbox. Software allows to enable membrane diffusion by entering
the fraction of inspired oxygen %. To zoom in on the graph toggle the Magnifier
button. Pressing OK, changes are confirmed (Cancel disregards them).
Button Function
Choose washout volume and sampling volume according to
ATS/ERS criteria

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6.4 Body Plethysmography

6.4.1 Test Overview


OMNIA allows to perform the Body Plethysmography tests shown in the menu
below.

Thoracic Gas Volume/Raw

Thoracic Gas Volume Post Dilator


Body
Plethysmography
TGV/Raw Simulated

Raw Challenge

Body Plethysmography test measures the Thoracic Gas Volume (TGV) and Airways
Resistance (Raw). TGV measurements by body plethysmography results highly
accurate particularly in subjects with lung diseases associated with gas trapping and
obstructed subjects, for whom dilution techniques may underestimate lung
volumes.
OMNIA provides three different testing modes: Thoracic Gas Volume/Raw, Thoracic
Gas Volume Post Dilator and Raw challenge (after BC). The TGV/Raw Simulated test
is available for verification purposes.

6.4.2 Real-time Interface


Thoracic Gas Volume/Raw (pre and post BD)
During test execution multiple graphs are shown: at the top a volume-time graph
and a flow-box pressure graph show real-time values; the latter shows the current
and the last loop with the open vent valve, however, these loops are not stored; at
the bottom the sRaw Captures, the TGV Captures and the SVC/IC Captures show the
latest captured maneuvers.

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To the right, there are three vertical bars representing real-time respiratory
frequency, tidal volume and box pressure, which help to check for stability. During
test execution the user interacts with the device using the additional commands:
Button Function
Perform Q-Box test with door open, no values will be displayed

Open vent valve (to be used if pressure is not stable inside the box, i.e.
no thermal equilibrium is reached)

Align the loop to the origin of the graph

Toggle the panting filter on/off: when toggled on, subject should
breath at a respiratory frequency between 0.5 Hz and 1 Hz

Capture a single sRaw

Capture consecutive sRaw (number of captures is defined in Body


Plethysmography Settings, refer to section 4.7.3)

Capture a single TGV (close the shutter)

Begin an EVC measurement following a TGV capture

Begin an IVC measurement following a TGV capture

Raw challenge
During test execution the Thoracic Gas Volume/Raw real-time interface is shown
(TGV Captures and SVC/IC Captures graphs are disabled).
After protocol selection, the protocol interface is as described in Forced Vital
Capacity Challenge. Refer to sections 6.2.2 and 6.2.3.
TGV/Raw Simulated
During test execution the Thoracic Gas Volume/Raw real-time interface is shown.

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6.4.3 Visit Review


TGV Visit Review panel allows switching between all performed body
plethysmography tests (Thoracic Gas Volume/Raw, Thoracic Gas Volume
Post Dilator, Raw challenge and TGV/Raw Simulated) by clicking the
corresponding tab to the right. Raw Challenge is indicated as TGV post BC.
TGV/Raw (pre and post BD)
In TGV/Raw Pre and Post BD panels, the complete spirogram (Volume vs
Time curve) is shown on the top, with all the captures represented by a
vertical (sRaw or FRC) or horizontal (TLC) line, each one marked with the
corresponding value. Below the spirogram, sRaw and TGV graphs show
details of the related captures. Results are reported as a percentage of the
predicted values and as z-scores. Predicted values and normal ranges for
each parameter are also reported, according to the selected predicted set.
Gauges which graphically display z-scores of main TGV/Raw parameters
relative to normal ranges are also shown for easy interpretation of the
results. The software displays the operator quality control and subject position
during the test, both of which are entered by the operator.
The following functions are available in addition to those described in section 6.1.3.
Button Function
Review polytropic factor calibration results

In addition to TGV/Raw pre results, the dose of the administered BD agent is shown
in the TGV/Raw Post BD panel. Pre and Post absolute numerical results and %
changes are both displayed.
TGV/Raw (post BC)
In the TGV/Raw post BC panel, the sRaw graph shows all maneuvers (different
protocol steps are indicated with different colors) and numerical results for each
protocol step show the average results (or median, refer to section 4.7.3) for all
accepted trials within each protocol step. Two graphs showing the % decrease in
sGaw and the % increase in sRaw against the protocol steps are also displayed.
Numerical results include PD45, PD40 and PD35 referring to sGaw % decrease and
PD100 referring to sRaw % increase. Users can visualize either Dose or Cumulative
dose results by selecting the item from the dropdown. The following functions are
available in addition to those described in section 6.1.3.

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Button Function
Show/hide TGV/Raw Pre graphical and numerical results

The trials performed within a protocol step can be edited by clicking on .


TGV/Raw Sim
In TGV/Raw Sim panel, the TGV graph shows all of the accepted maneuvers and the
averaged numerical results (or median, refer to section 4.7.3) for all of them. It is
only recommended for verification purposes and is therefore not intended to be
performed on subjects. The software displays the operator quality control.

6.4.4 Trial Edit


If multiple trials were performed, the TGV/Raw Edit panel opens. Trials can be
accepted/discarded or shown/hidden by checking the Accept and Show checkboxes,
respectively. Accepted captures are shown on the spirogram on the left through
vertical (sRaw or FRC) or horizontal (TLC) lines, each one marked with the
corresponding value. Users can modify the Operator QC and Position fields and
enter the agent dose (TGV/Raw post BC only). The following functions are available
in addition to those described in section 6.1.4.
Button Function
Accept all the trials

Review polytropic factor calibration results

Single captures can be edited by clicking on the corresponding icon and can be
cycled through using the left/right arrows. Captures can be accepted or discarded
by checking the Accepted checkbox in the lower left. Users can also modify the
Operator QC and Position fields. The following functions are also available in
addition to those described in section 6.1.4.

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Button Function
Export capture raw data in xls format

sRaw Capture Edit


On the left panel the spirogram is always shown having the capture under editing
represented with a bold vertical line. On the right panel the curve representative of
the capture under editing is shown. On the latter, users can switch between sRaw
and Insp/Exp editing functions by clicking on the corresponding upper tab.
On the sRaw editing graph users can modify the slope and the intercept of the
tangent by adjusting the corresponding sliders or by moving the ends of the
segment directly on the graph. This allows to determine the Raw and the sRaw,
which are shown below the graph and are updated in real-time. By default, the
regression line is plotted according to the algorithm defined in OMNIA settings
(refer to section 4.7.3).
On the Insp/Exp editing graph users can independently adjust the inspiratory Raw
and the expiratory Raw by selecting the corresponding radio button and modifying
the slope and the intercept for the selected loop by graphical or slider adjustment.
Raw ins and Raw exp are shown below the graph and are updated in real-time.

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TGV Capture Edit


The whole spirogram is shown to the left. The FRC level and the TGV value for the
selected capture are indicated by dashed blue and solid orange lines, respectively.
The FRC level can be adjusted on the spirogram by dragging the dashed line directly
on the graph or adjusting the slider below the graph. Voccl is reported below the
graph.
The Pmouth-Pbox graph is shown to the right and allows to adjust the FRC(Pleth) by
modifying the slope and the intercept for the selected loop by graphical or slider
adjustment. The FRC(Pleth) is shown below the graph and is updated in real-time.

Note: SVC adjacent to TGV must be accepted or TGV cannot be reported.

SVC Capture Edit


The whole spirogram is shown with a green shadowed area indicating the SVC
manoeuvre. SVC captures can be edited as described in section 6.2.4.

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6.5 Nitrogen Washout

6.5.1 Test Overview


OMNIA allows to perform the Nitrogen Washout tests shown in the menu below.

N2 Multi-Breath Washout
Nitrogen Washout
N2 Single-Breath Washout

Inert gas washout tests, performed using the single- or multiple-breath washout
techniques, measure ventilation distribution inhomogeneity at differing lung
volumes and offer complementary information to standard lung function tests, such
as spirometry.
Multi-Breath Nitrogen Washout (N2 MBW) aims at measuring FRC and Single-Breath
Nitrogen Washout (N2 SBW) aims at measuring Closing Volume (CV), and as a
consequence Closing Capacity (CC) if RV is known. CV reflects airway closure
occurring preferentially in dependent lung regions and peripheral airway
obstruction.

6.5.2 Real-time Interface


N2 Multi-Breath Washout
During test execution multiple graphs display real-time values. At test start a
volume-time graph is shown to the left to aid in determining when to activate
oxygen delivery; respiratory frequency and tidal volume are plotted against time to
the right. After the initiation of oxygen delivery, the chart to the left will display
FetN2 vs. CEV.

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To the right, FetN2, FeN2, CFRC, CEV and LCI real-time values are shown and two
vertical bars show real-time respiratory frequency and tidal volume, which help to
identify a normal breathing pattern. Tabular data is at the bottom.
N2 Single-Breath Washout
During test execution multiple graphs show real-time values. At test start a volume-
time graph is shown to aid in determining when to activate oxygen delivery. After
the initiation of oxygen delivery, the graph to the left will display expired N2
fraction vs. volume. To the right, flow is plotted against time and the target flow
range, as defined by ATS/ERS [7], is indicated by two dashed lines.

6.5.3 Visit Review


N2 MBW
N2 MBW Visit Review panel shows the results of N2 Multi-Breath Washout test. In
N2 MBW panel, charts (FRC graph and breathing pattern graph) and numerical
results show the best N2 multi-breath washout among the trials performed.
The FRC graph is a bar plot where % FetN2 is plotted against the cumulated expired
volume (CEV). The breathing pattern graph shows VT and Rf against time.
Results are reported as a percentage of the predicted values and as z-scores.
Predicted values and normal ranges for each parameter are reported too, according
to the selected predicted set. Gauges that show a graphical display of z-scores of
main N2 multi-breath washout parameters are also shown for an easy
interpretation of results.
The software displays the system quality control, the operator quality control and
subject position during the test, both of which are entered by the operator. The
following functions are available in addition to those described in section 6.1.3.
Button Function
Review gas calibration factors

N2 SBW
N2 SBW Visit Review panel shows the results of N2 Single-Breath Washout test. In
N2 SBW panel, charts (CV graph and flow graph) and numerical results show the
best N2 single-breath washout among the trials performed.
The CV graph shows expired % nitrogen against volume. The flow graph shows the
expiration flow against time. On this graph the recommended flow range (between
400 and 500 mL/min) is indicated by two horizontal dashed lines.

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Results are reported as a percentage of the predicted values and as z-scores.


Predicted values and normal ranges for each parameter are reported too, according
to the selected predicted set. Gauges that show a graphical display of z-scores of
main N2 multi-breath washout parameters are also shown for an easy
interpretation of results.
The software displays the system quality control, the operator quality control and
subject position during the test, both of which are entered by the operator. The
following functions are available in addition to those described in section 6.1.3.
Button Function
Review gas calibration factors

6.5.4 Trial Edit


N2 MBW
In N2 MBW Edit panel users can accept/discard trials, choose the best maneuver
among the performed trials and show/hide trials. Users can also modify the
Operator QC and Position fields and decide the FRC calculation method from the
dropdown. For further details on calculation methods please refer to section 0. The
following functions are also available in addition to those described in section 6.1.4.
Button Function
Execute a new N2 MBW trial

Accept all the trials

Automatically select the best trial according to ATS/ERS criteria

Accept only the three best curves according to ATS/ERS criteria

Review last gas calibration

Single N2 MBW trials can also be edited after clicking on the corresponding
icon.

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Main washout parameters are reported for each breath and the end of the phase
for the FRC calculation is indicated by a vertical dashed line on the FRC graph. Such
limit can be adjusted by moving the dashed line directly on the graph or by moving
the slider below the graph. Such editing tool is particularly useful for subjects who
accidentally inhale air during test execution with consequent increases in % FetN2:
the following breaths can be discarded by adjusting the end-of-phase line and the
FRC can be calculated upon the breaths preceding the air inhalation if the estimate
is not too rough and without the need to repeat the test.
The end of the phase for FRC calculation is restored to the test end if Restore is
pressed.

N2 SBW
In N2 SBW Edit panel user can accept/discard trials, choose the best maneuver
among the performed trials and show/hide trials. Users can also modify the
Operator QC and Position fields and decide the CV calculation method from the
dropdown. For further details on calculation methods please refer to section 0. The
following functions are also available in addition to those described in section 6.1.4.

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Button Function
Execute a new N2 SBW trial

Accept all the trials

Review last gas calibration

Single N2 MBW trials can also be edited after clicking on the corresponding
icon.
Three vertical dashed lines indicate the limits between the phases which can either
be dragged on the graph or the corresponding sliders below the graph can be
moved for adjustment. The phase III slope is shown on the graph with a dashed line,
whose regression equation is reported at the top of the graph. The calculation
method for the selected trial can be selected from the dropdown to the right (refer
to section 0 for further information).

Button Function
Autodetect starting and ending points of phase III

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6.6 Respiratory Mechanics

6.6.1 Test Overview


OMNIA allows to perform several Respiratory Mechanics tests (refer to the diagram
below).

Maximum Pressure

Airways Resistance Rocc

Airways Resistance Rocc Post Dilator


Respiratory Mechanics
Respiratory Drive

Forced Oscillation

Forced Oscillation Post Dilator

MIP and MEP are indices of the respiratory muscle strength at the mouth, which is
independent of the lung condition. MIP is an index of diaphragm strength, while
MEP measures the strength of abdominal and intercostal muscles [8]. Rocc test
measures airways resistance using the interrupter technique. Respiratory Drive
(P0.1) is the mouth occlusion pressure developed 0.1 s after the onset of
inspiration. The Forced Oscillation Technique (FOT) measures respiratory system
impedance at different frequencies.

6.6.2 Real-time Interface


Maximum Pressure
During test execution a volume-time graph is shown to the left to aid in determining
when to activate shutter closure. To the right mouth pressure is plotted vs. time and
shows all executed MIP/MEP maneuvers.
During test execution user interacts with the device via the following commands:

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Button Function
Activate shutter closure for MIP/MEP capture

Airways Resistance Rocc (pre/post BD)


During test execution in the top-left corner a flow-time graph is shown.
During test execution user interacts with the device via the following commands:
Button Function
Activate shutter closure for Rocc capture, if manual occlusion has been
selected in settings (refer to section 4.7.7 for further information)

Execute Respiratory Drive


During test execution P0.1 pressure is plotted against time to the left and against
FiCO2 to the right. Tabular data are shown at the bottom.
During test execution user interacts with the device via the following commands:
Button Function
Activate shutter closure for P0.1 capture

Execute Forced Oscillation (pre/post BD)


During test execution two graphs show real-time flow and mouth pressure vs. time.

6.6.3 Visit Review


Maximum Pressure
Maximum Pressure Visit Review panel is indicated by MIP/MEP in the upper tab.
The graph shows all executed maneuvers and numerical results show the best MIP
and the best MEP among the trials performed. Results are reported as percentage
of predicted values and as z-scores. Predicted values and normal ranges for each
parameter are also reported, according to the selected predicted set. Gauges that
show a graphical display of z-scores of MIP and MEP relative to normal ranges are
also shown for an easy interpretation of results.
System quality control is provided by OMNIA. The software also displays the
operator quality control and subject position during the test, both of which are
entered by the operator.

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Airways Resistance Rocc (pre/post BD)


Airways Resistance Visit Review panel is indicated as Rocc in the upper tab. Two
graphs are shown: Rocc and Gocc, which report all captures recorded during the
best Rocc trial. Expiratory and inspiratory Rocc and Gocc values are identified with
different markers on the graphs, and mean (or median, refer to section 4.7.7 for
further information) values are reported. Gauges that show a graphical display of z-
scores of Rocc and Gocc relative to normal ranges are also shown for an easy
interpretation of results.
In addition to Rocc Pre results, the dose of the administered BD agent is shown in
Rocc Post BD panel. Graphs and numerical results show Rocc Pre and Post results.
The software displays the system quality control, the operator quality control and
subject position during the test, both of which are entered by the operator.
Respiratory Drive
Respiratory Drive Visit Review panel is indicated as P0.1 in the upper tab. Two
graphs are shown: P0.1 and VT against time and P0.1 against PetCO2, for all
captures recorded during the best P0.1 trial. FiCO2, P0.1, VT, Rf and PetCO2 values
at all captures and mean values are reported.
The software displays the operator quality control and subject position during the
test, both of which are entered by the operator.
Forced Oscillation (pre/post BD)
Forced Oscillation Visit Review panel is indicated as FOT in the upper tab. A graph
shows the error bar plot of airways resistance and reactance at all driving
frequencies. The reactive area (Ax) is highlighted and predicted values are also
reported, if available.
Results are reported as percentage of the predicted values and as z-scores.
Covariance and standard deviation are also provided if multiple trials are accepted.
Predicted values and normal ranges for each parameter are reported too, according
to the selected predicted set. The software displays the operator quality control and
subject position during the test, both of which are entered by the operator.
The following functions are available in addition to those described in section 6.1.3.
Button Function
Review last I2m calibration (Quark i2m only)

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Review last Q-i2m characterization (Q-i2m only)

Review last Q-i2m calibration (Q-i2m only)

Review last Q-i2m filter characterization (Q-i2m only)

In addition to FOT pre results, the dose of the administered BD agent is shown in
FOT Post BD panel. Pre and Post results and absolute and % changes are shown.

6.6.4 Trial Edit


Maximum Pressure
In Maximum Pressure Edit panel users can accept/discard trials, independently
choose the best MIP maneuver and the best MEP maneuver amongst the
performed trials and show/hide trials. Users can also modify the Operator QC and
Position fields. The following functions are also available in addition to those
described in section 6.1.4.
Button Function
Perform a new Maximum Pressure trial

Accept all the trials

Automatically select the best MIP and MEP according to ATS/ERS


criteria

Single Maximum Pressure trials can also be edited after clicking on the
corresponding icon. The start and the end (red dashed vertical lines) of the MIP
(MEP) plateau can be changed to calculate MIP (MEP) properly. Volume-time curve
is plotted on the same graph to help locate the plateau correctly. A dashed
horizontal line moves as the plateau duration is adjusted, and it indicates the
maximum pressure of the trial. Pressing OK confirms the changes (Cancel disregards
them). MIP (MEP) and plateau Duration values beneath the graph are automatically
updated as the plateau interval is adjusted.

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Airways Resistance Rocc (pre/post BD)


In Airways Resistance Edit panel users can accept/discard trials and show/hide
trials. Users can modify the Operator QC and Position fields. In Rocc post BD Edit
panel, the user can modify the BD agent dose administered during the test.
The following functions are also available in addition to those described in section
6.1.4.
Button Function
Perform a new Airways Resistance trial

Accept all the trials

Single airways resistance trials can also be edited after clicking on the corresponding
icon. A pressure-time graph shows the overlap of all captures (occlusions)
performed within the trial. Single captures can be shown/hidden and
accepted/discarded by checking/unchecking the related checkboxes. Pressing Save
confirms the changes (Cancel disregards them).

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Respiratory Drive
In Respiratory Drive Edit panel users can accept/discard trials and accept/discard
trial steps. Users can also modify the Operator QC and Position fields. The following
functions are also available in addition to those described in section 6.1.4.
Button Function
Accept all the trials

Single Respiratory Drive trials can also be edited after clicking on the corresponding
icon. Single captures can be accepted/discarded by checking/unchecking the
corresponding checkbox. Captures can be discarded by deselecting them from the
graphs. Pressing Save confirms the changes (Cancel disregards them).
Forced Oscillation (pre/post BD)
In the Forced Oscillation Edit panel user can accept/discard trials and select one trial
to see additional details. Beneath the resistance and reactance graph, which shows
all the accepted trials and mean values, two graphs display additional information
for the selected trial: by clicking on the corresponding graph, users can choose
to display either flow and pressure vs. time or smoothed flow vs. time to the left
graph and either frequency-specific tabular data or coherence-frequency plot to the
right graph.
Users can also modify the coherence threshold, the Operator QC and Position fields.
In FOT post BD Edit panel, the user can modify the BD agent dose administered
during the test.

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6.7 6MWT

6.7.1 Test Overview


The 6-Minute Walk is a simple test performed to evaluate functional capacity and
estimate morbidity and mortality standard requirements. The Six Minute Walk Test
can be performed with the Spiropalm 6MWT and data can be downloaded to
OMNIA.

Note: The test cannot be performed using OMNIA, OMNIA only allows data
review and edit.

To download the test from the Spiropalm 6MWT, please refer to the section 5.3.3.

6.7.2 Visit Review


In 6MWT Visit Review panel, charts (SpO2, Cardiovascular, and Ventilatory
Response) and numerical results show the best 6MWT among the trials performed.
The SpO2 and Cardiovascular graph shows SpO2 and HR vs. time. The ventilatory
response graphs shows VE, Rf and IC vs. time and two dashed lines indicate MVV
and BR. The charts can be customized according to section 9.2.
Numerical results are shown to the right and users can switch between Summary
and Step Data views by clicking on the corresponding tabs. Summary results are
divided by data type.
Gauges of main 6MWT parameters are also shown for an easy interpretation of
results.

6.7.3 Trial Edit


In 6MWT Edit panel user can accept/discard trials by selecting the corresponding
Accepted radio button. Tabular data are reported and the selected steps are
highlighted on the charts.
Single 6MWT trials can also be edited after clicking on the corresponding icon.
IV and IVmax are shown in the upper chart and the ventilatory response graph is
shown on the lower. Single steps can be discarded from the tabular data by clicking
on Delete and IC markers can be added by selecting the corresponding checkbox
indicating an IC was performed.

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Field Description
6MWD Enter distance covered during the 6MWT
Baseline dyspnea Select baseline dyspnea value from the dropdown
Final dyspnea Select final dyspnea value from the dropdown
Baseline fatigue Select baseline fatigue value from the dropdown
Final fatigue Select final fatigue value from the dropdown
Other symptoms Select symptoms from the dropdown
Suppl. O2 Select if supplemental oxygen was provided
Sup. O2 flow Enter the flow of supplemental oxygen
P Syst Enter systolic pressure
P Diast Enter diastolic pressure
Baseline FEV1 Enter baseline FEV1

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6.8 Metabolic - CPET

6.8.1 Test Overview


OMNIA allows to perform the metabolic tests shown in the diagram below.

CPET Breath by Breath


Cardio Pulmonary
Excercise Testing
CPET Mixing Chamber

Cardiopulmonary Exercise Testing (CPET) allows evaluation of the heart and lungs
under stress conditions that may be induced via several different protocols, by
means of the measurement of Oxygen consumption and Carbon Dioxide production
rates. The two common methods for analysing exhaled gases use either a mixing
chamber or breath-by-breath measurements, and both methods can be used for
performing a CPET test on Quark PFT. Although the mixing chamber mode does not
provide real-time values, at high respiratory frequencies (>60 breaths per minute) it
is more accurate than the Breath-by-Breath method.

6.8.2 Real-time Interface


At the beginning of a test, a window appears and allows to configure the following
fields.
Test
Field Description
Type Select test type from the dropdown
Data filtering Select data filtering algorithm from dropdown (BxB only)
Subject Type Select subject type from dropdown
Anti Bacterial Filter Check if the anti-bacterial filter is used for testing (BxB only)
Simulated Check if a simulated test is performed (BxB only)

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Ergometer*
Field Description
Select ergometer from the dropdown (refer to section 13.6 for
Ergometer
further information)
Select protocol from the list of available protocols in the dropdown
Protocol
(as defined in section 9.3.1)
Port Enter ergometer communication port
*this field becomes inoperable if GE® Cardiosoft-CASE or Cardiolex® EC Sense are selected as
HR source (see below).

Note: OMNIA Misc Ergometers Drivers module (REF A-670-100-010) may be


required to operate with some specific ergometers.

Spirometry
Enter the following spirometry information to estimate peak minute ventilation and
calculate the breathing reserve. These fields are pre-populated if spirometry has
been performed in the same visit (refer to section 4.7.5 for MVV multiplying factor
adjustment).
Field Description
FEV1 Enter subject’s FEV1
IC Enter subject’s IC
FVC Enter subject’s FVC
VC Enter subject’s VC

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Integrated Devices
Field Description
Select the HR source and/or ECG source from the dropdown:
None: no HR monitor
Metabolic Cart: HR retrieved from a HR monitor, TTL ECG
or oximeter connected to the metabolic cart (refer to
sections 13.4.1 and 13.4.3 for further information)
PC Software ECG: ECG parameters retrieved from
integrated PC ECG (refer to section 13.4.2 for further
information)
Ergometer
HR Source
Mortara XScribe: ECG parameters retrieved from
Mortara® ECG (refer to section 13.4.4 for further
information)
GE Cardiosoft-CASE: ECG parameters retrieved from GE®
Cardiosoft-CASE ECG (refer to section 13.4.5 for further
information)
Cardiolex EC Sense: ECG parameters retrieved from
Cardiolex® EC Sense ECG (refer to section 13.4.6 for
further information)
Blood Pressure Select the blood pressure source from the dropdown:
None
Manual: manual blood pressure monitoring
Bike
Tango®: systolic and diastolic blood pressure retrieved
from Tango® (refer to section 13.4.6 for further
information)
Port Enter blood pressure communication port
Emogas Analyzer Select emogas analyzer source from the dropdown:
None
Radiometer (MonLink 2.0): ABG parameters retrieved
from Radiometer® TCM5 (refer to section 13.4.8 for
further information)
SenTec DMS: ABG parameters retrieved from SenTec®
DMS (refer to section 13.4.7 for further information)
Port Enter emogas analyzer communication port

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Physioflow Enter Physioflow communication port (refer to section 13.4.9 for


further information)

Note: OMNIA AUX Devices Integration module (REF A-670-100-023) may be


required to interface external devices.

During test execution the user can choose the real-time dashboard from the
available dashboards, as listed in section 9.2, by clicking on the corresponding tab
below the tabular data. Charts and tabular data can be customized as defined in
section 9.2.
User can also interact with the device via the following commands:
Button Function
Begin recording data (refer to section 4.7.5 for automatic start)

Pause the protocol and data recording (time is not interrupted)

View protocol phases and choose one phase by clicking the


corresponding button amongst the following:

Rest

Warm-up

Exercise

Recovery
Insert a text marker by either typing the marker label or selecting an
existing marker label from the dropdown (refer to section 10 -
Resource Center). The marker is inserted as soon as OK is pressed
Enter blood pressure values (automatic or manual entry, as defined at
test start)

Select the RPE value for dyspnea according to the scale selected in
OMNIA Settings (refer to section 4.7.5)

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Select the RPE value for leg pain according to the scale selected in
OMNIA Settings (refer to section 4.7.5)

Add a marker to indicate Arterial Blood Gas (ABG) or lactate reading.


Values can be edited after the test is complete

Select to perform an exercise flow-volume loop (BxB only)

Enter recovery phase of the protocol

Two widgets can be used for real-time protocol adjustment and can be switched
through the left/right arrows on the protocols widget.
Widget Function

Protocol control (available after protocol selection


only): allows to pause the current protocol (data
recording is not stopped) or to skip to next step

Ergometer control: allows adjustment of ergometer


load by pressing + or - (protocol changes to manual
control)

switch to manual control (protocol stops)

set the increment for + and -

Exercise flow-volume loops


Pulmonary function measurements may be useful during exercise testing to detect
abnormalities in the mechanics of ventilation for subjects with ventilatory
limitations to exercise. The test consists in acquiring Flow-Volume loops during
exercise at varying workloads and superimposing them on the subject’s resting
Flow-Volume loop. The flow-volume loop interface is shown below.

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The flow-volume graph and the volume-time graph are shown and dyspnea and leg
pain RPE values can be entered by clicking on the corresponding button. A powerful
interface allows the offline review and editing of all EFVL captures (refer to section
6.8.4).

6.8.3 Visit Review


CPET Visit Review panel allows to switch between Breath-by-Breath tests and
Mixing Chamber tests by clicking on CPET BxB and CPET MIX tabs to the right,
respectively. CPET Visit Review panel allows to visualise test results, dashboards,
ECG report and an analysis panel by clicking on Results, Dashboards, ECG and
Analysis left tabs. The following additional left tabs are available on CPET Visit
Review panel after editing: ABG, EFVL (BxB only), O2 Kinetics.

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Results

Graphical and numerical results are shown in the Results panel. The chart can be
customized according to section 6.1.2 and 9.2. Protocol information (including if an
ECG was used as HR source) are reported below the graph and numerical results are
shown to the right, divided by type. From the Summary dropdown users can choose
the results to display, as per defined in section 9.2. Gauges relative to normal ranges
are also shown for easy interpretation of the results. The following functions are
available in addition to those described in section 6.1.3.
Button Function
Edit test

Export coordinates as KML or open in Cesium (internet


connection required).
Available for tests with GPS coordinates (K5 tests performed outdoors)
Review last gas calibration

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Dashboards
From the Dashboard panel users can choose the results dashboard from the
available dashboards, as defined in section 9.2, by clicking on the corresponding tab
below the tabular data. Charts and tabular data can be customized as defined in
section 9.2 and each chart can be printed by clicking .
ECG
The ECG panel shows the ECG report in PDF format. The following function is
available in addition to those described in section 6.1.3.
Button Function
Edit ECG (enabled according to the ECG configuration). ECG editing is
described in section 6.8.4

Analysis
The Analysis panel allows users to analyse data using regression tools. To the left a
chart is shown. To the right the fitting parameters for the selected graph are divided
by regression type.
Button Function
Add new fitting set for the selected graph

A fitting window opens and the selected chart is shown with vertical lines indicating
the regression interval. The time interval can be adjusted by dragging the lines
directly on the graph or by moving the slider to the right. Users can also choose the
regression type from the dropdown and enter the number of iterations (Max
Attempts). The fitting can then be calculated using the following:
Button/slider Function
Calculate parameters for the selected regression type

Restore the default fitting parameters. Always press this button before
Calculate if the interval has changed

Slide right to lock the corresponding parameter to set value

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Pressing OK saves the fitting and lists it in the Analysis panel. Users can edit each
fitting via the following functions:
Button Function
Edit selected fitting

Delete selected fitting

Note: Fittings are not saved in the Analysis panel after exiting the visit.

ABG
The ABG panel shows entered ABG values for all steps with ABG markers (both
received/entered during the test and entered during test editing).
EFVL
The EFVL panel shows the flow-volume loops analysis, if edited. To the left all EFVL
events are shown. To the right the summary of all accepted events and VE and
power plot against time are shown. Charts can be customized according to section
6.1.2.
O2 Kinetics
The O2 Kinetics panel shows the O2 kinetics analysis, if edited. To the left a chart
plots O2 and power against time and can be customized according to section 6.1.2.
Edited O2 kinetics fittings are listed to the right and are graphically superimposed
on the O2 curve with different colors.
Steady State
The Steady State panel shows the steady state analysis, if edited. To the left a chart
plots the steady state stages and can be customized according to section 6.1.2. To
the right tabular data summarize the parameters values at the different stages.
Training Zones
The Training Zones panel shows the training zones analysis, if edited. To the left a
chart highlights the training zones according to the color code set for each zone (see
section 9.5). To the right tabular data summarize the parameters values for the
different zones.

6.8.4 Trial Edit

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CPET Trial Edit panel allows switching between the tabs described above. As the
edits are performed, the corresponding tabs receive a green check mark.
Immediately after a test has ended, only the VO2max is automatically calculated
and shows up on the VO2 Max tab.
Overview
CPET Edit Overview panel allows users to review and edit graphs, numerical data
and test information.
Field/slider Description
Subject type Select subject type from the dropdown:
Clinical
Healthy
Test type Select test type from the dropdown:
Maximal
Submax
Other
FVC Post Ex (L) Enter FVC post exercise
FEV1 Post Ex (L) Enter FEV1 post exercise
Reason for test Select reason for test from the dropdown. Default values are listed.
Refer to section 10 - Resource Center for additional values
Reason for Select reason for stopping the test from dropdown. Default values
stopping test are listed. Refer to section 10 - Resource Center for additional values
Test Purpose Select test purpose from the dropdown. Default values are listed.
Refer to section 10 - Resource Center for additional values
Test Position Select test position from the dropdown:
Undefined
Standing
Sitting
Supine
ECG Response Select ECG response from dropdown:
None
Normal
Borderline
Abnormal
Anti Bacterial Filter Check/uncheck box if anti-bacterial filter was used during the test

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Set the test as best test (best test data are used in the Visit Review
Overview tab and in printouts)

Charts can be customized according to section 6.1.2. The following functions are
available:
Button Function
Edit and filter tabular data (description below)

Edit exercise phase. A window appears which shows an editable graph


and allows to adjust the exercise phase time interval using the slider or
by dragging the vertical lines. Changes are saved by clicking on OK
Edit ABG. A window appears which allows to enter ABG values for all
steps with ABG markers. Changes are saved by clicking on OK

Edit ECG (described below)

Review gas calibration factors

Edit and filter


By clicking on a new edit panel opens with two editable graphs to the left
and tabular data to the right. Users can filter data by selecting the algorithm
from the Data filtering dropdown. Users can also filter by phase by selecting the
corresponding checkboxes or by time by adjusting the Time filter slider.

Note: Data filtering does not delete the raw data.

Single steps can be ignored by selecting the Ignore checkbox and ABG markers
can be added by selecting the ABG checkbox. All fields can be modified. The
following functions are also available:

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Button Function
Delete selected steps

Delete invalid steps as defined in section 4.7.5

Load ergometer and exercise protocol for the selected time


interval. Interval adjustment and ergometer and protocol selection
are saved by clicking on OK
Perform an advanced editing of the steps. A window appears
which allows to delete steps or edit parameters. A parameter can
be selected from the dropdown and the following functions are
available:
Value: replace all values with entered value
Correction%: apply % correction factor to all values
Offset: insert offset to values
Smoothing: perform a smoothing on the entered number
of steps
The deletion or the parameter edit are applied to the adjusted
time range, if selected, and to the adjusted parameter range
(defined by parameter, condition and value), if selected
Restore steps to the raw data discarding all the edits

Discard edits and restore values to previously saved values

Edit ECG
The function is available only if a PDF is generated in the ECG software.
The ECG Edit function automatically opens the ECG software where all test edits
can be performed. According to the ECG configuration, OMNIA software may
show the steps required for editing a test, the software where to perform the
actions and the related buttons.

Note: After test editing a new PDF should be generated in PC ECG software.

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Refer to sections 13.4 for further information about ECG integration.

Changes are applied after pressing Save.


VO2max
The VO2max panel shows four editable graphs (VO2 vs. time, Power vs. time, HR
and RQ vs. time, VE and Rf vs. time by default) and allows to determine the
VO2max. Users can adjust the time interval for the VO2max calculation by moving
the corresponding slider or dragging the Start and End vertical lines on the VO2-
time graph. The resulting VO2 is indicated by a horizontal purple line and reported
numerically. Users also can select the Max Effort Confirmed checkbox to indicate a
maximal effort was reached during the test. The following functions are also
available:
Button Function
Edit exercise phase. A window appears which shows an editable graph
and allows to adjust the exercise phase time interval using the slider or
by dragging the vertical lines. Changes are saved by clicking OK
Autodetect the time interval for the VO2max calculation

Discard edits and restore values to previously saved values

Changes are applied after pressing Save.


Thresholds
The Thresholds panel shows four editable graphs (VCO2 vs. VO2, VE/VCO2 and
VE/VO2 vs. time, HR, Power and lactate against time, PetO2, PaO2, PetCO2, PaO2
vs. time by default) and allows to determine VT1/LT1 (Threshold 1) and VT2/LT2
(Threshold 2). Users can edit VT1/LT1 and VT2/LT2 by moving the corresponding
sliders or dragging the VT1/LT1 and VT2/LT2 vertical lines on the graphs. The
regression lines can be shown/hidden by activating/deactivating the Lines toggle.
Users can superimpose a 45° triangle on the VCO2-VO2 graph to calculate threshold
1 using the V-Slope method by activating the Square toggle and a Magnifier toggle is
also available to zoom in on the graph. The following functions are also available:

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Button Function
Autodetect the time intervals for VT1/LT1 and VT2/LT2

Discard edits and restore values to previously saved values

Changes are applied after pressing Save.


VE Response
The VE Response panel shows three editable graphs (VE/VCO2 slope, OUES and
Oscillatory Breathing by default) and allows the calculation of the VE/VCO2 slope
and the OUES (Oxygen Uptake Efficiency Slope). Users can edit the VE/VCO2 slope
and OUES by moving the corresponding sliders or dragging the vertical lines on the
VE-VCO2 graph and VO2/LogVE graph, respectively. The Oscillatory Breathing
Confirmed checkbox should be checked if the operator confirms the presence of
oscillatory breathing. The following functions are also available:
Button Function
Autodetect VE/VCO2 and OUES values

Discard edits and restore values to previously saved values

Changes are applied after pressing Save.


VO2/WR - O2 pulse
The VO2/WR - O2 pulse panel shows two editable graphs (VO2 vs. power and
VO2/HR vs. time by default) and allows the calculation of the VO2/WR slope. Users
can edit the VO2/WR slope by adjusting the exercise phase interval using the
corresponding slider or dragging the exercise phase vertical lines on the VO2-Power
graph. Users can select the observed behaviours for VO2/WR and VO2/HR (O2
pulse) from the corresponding dropdowns. The following functions are also
available:

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Button Function
Autodetect the exercise phase interval

Discard edits and restore values to previously saved values

Changes are applied after pressing Save.


O2 Kinetics
The O2 Kinetics panel is visible if the corresponding setting has been enabled (see
section 4.7.5). The O2 Kinetics panel allows users to analyse the oxygen
consumption trend by means of regression tools. To the left a chart shows VO2 and
power vs. time. To the right all the fittings performed on the VO2 curve are listed.
New fittings can be added by clicking the Add button. A fitting window opens and
the chart is shown with vertical lines indicating the regression interval. The time
interval can be adjusted by dragging the start and end lines directly on the graph or
by moving the slider to the right. Users can enter the number of iterations (Max
Attempts) for the linear regression. The fitting can then be calculated by means of:
Button Function
Calculate fitting parameters

Restore default fitting parameters. Always press this button before


Calculate if the interval has changed

Slide to lock the corresponding parameter to set value

By pressing OK the fitting is saved and listed in the O2 Kinetics panel. Users can edit
each fitting via the following functions:
Button Function
Edit selected fitting

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Delete selected fitting

EFVL
The EFVL panel shows all EFVL events to the right. The FVC pre loop is reported in
grey on all EFVL events, if performed within the same visit. The basal loop is shown
is red and accepted loops for each event are colored in blue.
To the left the summary of all accepted events is shown and VE and power are
plotted vs. time, with markers indicating when EFVL were performed. The summary
graph shows EELV, EILV, leg pain and dyspnea values for all events and a grey
dashed line indicates Basal IC - 400 mL. The distance between the EILV and EELV,
graphically represented by the grey area, is the VT. Charts can be customized
according to section 6.1.2. Users can also select the Dynamic Hyperinflation
Confirmed checkbox when the possibility of dynamic hyperinflation is detected (i.e.
EELV graph is above the Basal IC - 400 mL line).
Single EFVL events can be customized by clicking on the corresponding icon.

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By selecting the Accepted checkbox the event is accepted and included in the
summary. Users can confirm flow limitation by selecting the corresponding
checkbox. Dyspnea and leg pain RPE values can be entered from the dropdowns.
The breath to associate with the EFVL event is highlighted in orange on both the
flow-volume and volume-time graphs and can be selected navigating through the
left/right arrows.
Steady State
The Steady State panel allows users to analyse the trend of parameters during a
test, assuming that a steady state protocol has been used. To the left a
customizable chart (see section 6.1.2) shows Power, Speed, Grade and VO2/Kg vs.
time. To the right all the steady state parameters are listed for each stage. Steady
state stages can be added and edited by means of:
Button Function
Add a stage before the selected one

Add a stage after the selected one

Delete the selected stage

Autodetect all steady state stages across the test

Discard edits and restore values to previously saved values

Users can define the time range of selected stages by moving the corresponding
time slider or dragging the dashed vertical lines on the graph.
Zones
The Zones panel is visible if the corresponding setting has been enabled (see section
4.7.5). The Zones panel allows to edit the training zones and the Maximum Fat
Oxidation, if the corresponding setting has been enabled (see section 4.7.5). It
shows two editable graphs (Fat vs. time and VO2/Kg vs. HR by default). On the
Maximum Fat Oxidation chart users can select the FatMax (FM) point by adjusting

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the corresponding slider or dragging the vertical line. The selected FM is then
highlighted on the Training Zones chart by means of a marker.
To the right FM tabular data are shown according to the selection and training
zones tabular data are shown after selecting the Zones protocol from the dropdown
(see section 9.5 for training zones protocols edit).

Note: Zones overlap can be avoided by manually modifying the HR values.

The following functions are also available:


Button Function
Toggle to show/hide Maximum Fat Oxidation chart and data

Autodetect the FatMax (FM) point

Discard edits and restore values to previously saved values

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6.9 Metabolic - REE

6.9.1 Test Overview

REE Canopy

REE Ventilator

Resting Energy
REE Ventilator (Q-NRG)
Expenditure

REE Mask (Q-NRG)

REE Mask

Oxygen consumption (VO2) and Carbon Dioxide Production (VCO2) are measured to
calculate the Resting Energy Expenditure (REE), or Resting Metabolic Rate (RMR),
and the Respiratory Quotient (RQ), representing the substrates of metabolism.
REE measurements act as a precise tool for determining a subject’s basal nutritional
requirements and provide information which allow for adequate nutritional intake.

6.9.2 Real-time Interface


During test execution the user can choose the real-time dashboard from the
available dashboards, as described in section 9.2.4, by clicking on the corresponding
tab below the tabular data. Charts and tabular data can be customized as defined in
section 6.1.2.
User can also interact with the device using the additional commands:

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Button Function
Start recording data

Pause the protocol and data recording (time is not interrupted)

Average data over the specified interval (this can be edited after the
test)

Insert a text marker by either typing the marker label or selecting an


existing marker label from the dropdown. The marker is added as soon
as OK is pressed

Select to adjust the bias flow (REE Ventilator only)

Enter information about subject (different than the subject card)

Bias Flow (REE Ventilator)


The bias flow window for REE Ventilator test is reported below. It shows a graph
with measured flow and CO2 at the ventilator output and numerical data for VT, Rf
and bias flow. Users can adjust the bias flow dashed line by dragging the indicator to
the left or by clicking the ±1 and ±5 buttons. The flowmeter at the ventilator output
only measures the exhaled air from the subject. Therefore, the dotted horizontal
line must be placed at the measured flow during the inspirations (usually the
minimum, see the illustration below).

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Canopy blower (REE Canopy)


The following interface can be used for real-time blower adjustment to maintain
FeCO2 within the acceptable range (0.5-1.5). FeCO2 must be verified before starting
a test and maintained within the range during the test to avoid subject’s
hyperventilation with consequent artificial increase in REE.
Widget Function

Blower control: allows to change the pump ventilation


(VP) by pressing + or - or by rotating the knob

set VP as a percentage of maximum pump


ventilation

set the increment for + and -

6.9.3 Visit Review


REE Visit Review panel allows to switch between mask, canopy and ventilator tests
by clicking on REE Mask, REE Cnpy and REE Vent tabs, respectively.
REE Visit Review panel allows to visualise test results and dashboards by clicking on
the corresponding tabs to the left.

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Results
Graphical and numerical results are shown in the Results panel. The chart can be
customized according to section 6.1.2. Protocol information are reported below the
graph and numerical results are shown to the right, divided by type. Gauges relative
to normal ranges are also shown for easy interpretation of results. The following
functions are available in addition to those described in section 6.1.3.
Button Function
Edit test

Review gas calibration factors

Dashboards
From the Dashboard panel users can choose the results dashboard from the
available dashboards, as listed in section 9.2.4, by clicking on the corresponding tab
below the tabular data. Charts and tabular data can be customized as defined in
section 6.1.2 and each chart can be printed by clicking on .
Analysis
The Analysis panel allows users to analyse data using regression tools. To the left a
chart is shown. To the right the fitting parameters for the selected graph are divided
by regression type.
Button Function
Add new fitting set for the selected graph

A fitting window opens and the selected chart is shown with vertical lines bordering
the regression interval (highlighted). The time interval can be adjusted by dragging
the lines directly on the graph or by moving the slider to the right. Users can also
choose the regression type from the dropdown. The fitting can then be calculated
using the following:
Button/slider Function
Calculate parameters for the selected regression type

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Pressing OK saves the fitting and lists it in the Analysis panel. Users can edit each
fitting via the following functions:
Button Function
Edit selected fitting

Delete selected fitting

Note: Fittings are not saved in the Analysis panel after exiting the visit.

6.9.4 Trial Edit


REE Trial Edit panel allows to switch between the tabs described below.
Overview
REE Edit Overview panel allows users to review and edit graphs, numerical data and
test information.
Field/slider Function
AMR Enter subject’s activity metabolic rate
Enter subject’s urinary nitrogen for substrates calculation including
UN
protein metabolism
Daily Intake Enter subject’s daily intake
Body T Enter subject’s body temperature
Fasting Period Select subject’s fasting period from the dropdown
Resting period Select subject’s resting period from the dropdown
Test Position Select test position from the dropdown:
Undefined
Standing
Sitting
Supine
Ventilation (REE Vent only)
Modality Enter ventilation modality
Agitation Select subject’s agitation level from dropdown:

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N/A
Low
Medium
High
Sedation Select sedation level from dropdown:
N/A
Low
Medium
High
Severity (APACHE (REE Vent only)
III) Select severity from dropdown according to APACHE III
classification
Test Purpose Select test purpose from the dropdown. Default values are listed.
Refer to section 10 - Resource Center for additional field values
Set the test as best test (best test data are used in the Visit Review
Overview tab and in printouts)

Charts can be customized according to section 6.1.2. The following functions are
available:
Button Function
Edit and filter tabular data (description below)

Review gas calibration factors

Edit and Filter


By clicking on a new edit panel opens with two editable graphs to the left
and tabular data to the right. Users can filter data by selecting the algorithm
from the Data filtering dropdown. Users can also filter the phase by selecting
the corresponding checkboxes or time-filter the steps by adjusting the Time
filter slider.

Note: Data filtering does not delete the raw data.

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Single steps can be ignored by selecting the Ignore checkbox and all fields can
be modified. The following functions are also available:
Button Function
Delete selected steps

Delete invalid steps as defined in section 4.7.6

Perform an advanced editing of the steps. A window appears


which allows to delete steps or edit parameters. A parameter can
be selected from the dropdown and the following functions are
available:
Value: replace all values with entered value
Correction%: apply % correction factor to all values
Offset: insert offset to values
Smoothing: perform a smoothing on the entered number
of steps
The deletion or the parameter edit are applied to the adjusted
time range, if selected, and to the adjusted parameter range
(defined by parameter, condition and value), if selected
Restore steps in raw format discarding all the edits

Discard edits and restore values to previously saved values

Changes are applied after pressing Save.


AVG REE
The AVG REE panel contains two editable graphs (EEkc vs. time and VO2 and VCO2
vs. time by default) and allows to determine the averaging interval. Multiple
intervals can be created and users can adjust each time interval by moving the
corresponding slider or dragging the Start and End vertical lines on the EEkc vs. time
graph. The resulting average is indicated by a horizontal purple line and reported
numerically. The total duration of the averaging intervals is reported numerically.
The following functions are also available:

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Button Function
Add additional averaging interval after the selected interval

Add additional averaging interval before the selected interval

Split the selected averaging interval in two intervals

Remove the selected averaging interval

Select the best (lowest RMR variability) 5-minutes averaging interval

Discard edits and restore values to the ones previously saved

Changes are applied after pressing Save.

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6.10 Pulse Oximetry

6.10.1 Test Overview


Pulse Oximetry measures the hemoglobin saturation, i.e. the percentage of the
blood hemoglobin bearing oxygen. Tests can be performed at rest or under stress
conditions with the Nonin 3150 WristOx2 BLE Pulse Oximeter. Two different testing
modalities are available:
Real-time mode: the test can be performed with OMNIA, once a valid
Bluetooth® link is established with the pulse oximeter. Users can adjust the
protocol, monitor real-time trends of parameters and add markers.
Holter mode (offline): the test can be performed offline with data stored
only on the device. A worksheet with subject’s data and protocol
information can be printed to track events. Holter test download to OMNIA
can be performed according to section 5.3.3.

Note: When using Bluetooth®, data loss may occur due to radio interferences or
exceeded transmission range; the entire test can be downloaded to PC after
test is completed.

6.10.2 Real-time Interface


Test Options
At the beginning of a test, a window appears and allows to configure test options.

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Device Test Options


Button/Field Description
Device Select pulse oximeter from the dropdown
Start Bluetooth® device discovery

Stop Bluetooth® device discovery

Clear Data Erase all data stored on the pulse oximeter


Protocol Select protocol from dropdown
Create a new protocol. The protocol window appears (see
below)

Edit selected protocol

Delete selected protocol

Offline Download the worksheet for Holter mode testing

Protocol Options
Field Description
Name Enter protocol name
Baseline Enter baseline phase duration
Exercise Enter exercise phase duration
Recovery Enter recovery phase duration
Walk Path Enter the walk path distance
Select the lap increment from the dropdown (1 or 2 walk
Lap Increment
paths)
Pause Check to set options for exercise timer and pause timer
Select exercise timer options from the following:
Exercise Timer Reset: exercise timer restarts from 0 after each pause
Cumulative: exercise timer cumulates all exercise phases

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Include Pause: exercise timer cumulates all exercise and


pause phases
Select pause timer from the following:
Pause Timer Reset: pause timer restarts from 0 at each pause
Cumulative: pause timer cumulates all pause phases

Real-time execution
During test execution a graph to the left displays real-time HR and SpO2% values,
and to the right real-time values are shown for HR, SpO2 %, walking distance, PI %,
exercise duration, recovery duration and test duration. The plethysmographic
waveform is also shown on the bottom right corner. Tabular data is at the bottom.
During test execution the icons below should be checked to ensure reliable
measurements.
Icons Indication
Poor detecting signal. Data are not transmitted

Good detecting signal. Data are transmitted

Bluetooth® connection with the device has been lost

The device is connected

Device battery status

Heart rate

High-quality measurement (SpO2/HR)

During test execution, user interacts with the device via the following commands:
Button Function

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Enter Exercise phase

Enter pause when icon is solid. Resume exercise phase when


flashing

Enter Recovery phase and automatically open subject and test info
box

Enter info on the O2 Supplement (L/min and %), if present

Insert a text marker. The marker is inserted as soon as OK is


pressed.

Enter blood pressure values

Select the RPE value for dyspnoea according to the scale selected in
OMNIA settings

Select the RPE value for leg pain according to the scale selected in
OMNIA settings

Enter subject and test info

Insert a marker when the subject completes a lap

Protocol phases are highlighted on the graph according to the following colour
code.
Phase Color
Rest Dark yellow
Exercise Green
Pause Dashed
Recovery Yellow

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6.10.3 Visit Review


POx Visit Review panel allows to switch between pulse oximetry tests by clicking on
the corresponding tabs to the right. A graph to the left shows SpO2 and HR against
time, the selected protocol phases highlighted in different colours and all markers
inserted during real-time testing along the x-axis. Numerical results are shown to
the right and users can switch between Summary and Data views by pressing on the
corresponding tabs. Summary results are divided by data type.
A gauge which graphically displays the z-score of the 6MWD relative to the normal
range is also shown for an easy interpretation of the results.

The following functions are also available:


Button Function
Edit test

Print test

Export test

6.10.4 Trial Edit

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POx Edit panel allows to edit tabular data and to enter additional information for
the selected test.
Field Description
Laps Completed # Enter the number of complete laps
Final Partial Lap Enter the distance of the final partial lap
Total Pauses # Enter the number of pauses during test
Total Pauses Enter the total pause duration
Duration (mm:ss)
mMRC Dyspnea Select the mMRC value from the dropdown
Scale
FEV1 Enter FEV1
Walking Speed Enter the walking speed
PaO2 (mmHg) Enter PaO2 at the end of the test
Reason for Select reason for stopping the test from dropdown. Default values
Stopping Test are listed. Refer to section 10 - Resource Center for additional values
Medication before Enter medication before test
test
Supplemental Select supplemental oxygen type from the dropdown:
Oxygen Type Pulse dose
Continuous flow
Delivery Device Select supplemental oxygen delivery device from the dropdown:
Nasal cannula
Oxygen pendant
Mode of Transport Select supplemental oxygen transport mode from the dropdown:
Carried shoulder unit
Pushed/pulled cylinder
Walking Aid Select walking aid from the dropdown
Walking Enter walking limitations
Limitations
Comments Enter comments

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The graph and tabular data are shown on the left and a vertical black line highlights
the selected step on the graph. To the right, test data are shown, and additional
information can be entered or selected from the dropdown.
The following functions are also available.
Button/slider Function
Edit the exercise phase interval. See below for further
information

Perform an advanced editing of the steps. See below for


further information

Discard edits and restore values to previously saved values

Set the test as best test (best test data are used in the Visit
Review Overview tab and in printouts)

Edit Exercise Phase Interval


By clicking on a window appears which allows to edit the exercise phase
interval. The protocol to apply to the test can be selected from the dropdown. The
selected protocol can be edited or new protocols can be created according to

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section 6.10.2. The protocol phases are shown in different colours on the graph and
users can adjust the exercise phase by moving the corresponding sliders or dragging
the start and end vertical lines on the graph.

Advanced edit
By clicking on a window appears which allows to delete steps or edit
parameters. A parameter can be selected from the dropdown and the following
functions are available:
Value: replace all values with entered value
Correction%: apply % correction factor to all values
Offset: add offset to values
The deletion or the parameter edit are applied to the adjusted time range, if
selected, and to the adjusted parameter range (defined by parameter, condition
and value), if selected.

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6.11 ECG

6.11.1 Test Overview


OMNIA allows to perform the ECG tests shown in the diagram below.

ECG Stress
ECG
ECG Resting

The overall goal of performing an ECG is to obtain information about the electrical
function of the heart. ECG Resting records and measures short ECG tests on subjects
in resting position. ECG Stress records and measures ECG tests on subjects under
stress conditions using a pre-defined test protocol.

6.11.2 Real-time Interface


OMNIA real-time interface for ECG tests appears as shown in the picture below.
During test execution the user interacts with OMNIA and with PC ECG software.
To the left-hand side a list of procedural steps shows the procedure to perform the
test, the software to use for each action and the related buttons. To the right-hand
side the users can choose the lead color code (AHA or IEC) by selecting the
corresponding radio button.
As soon as ECG Stress/ECG Resting is selected from the ECG Testing menu, the
Stress PC ECG/Resting PC ECG software is opened by OMNIA and allows to configure
the settings for the test execution (these settings will be saved for subsequent ECG
only tests). OMNIA shows the actions to perform to run a test, as shown in the
picture below. For additional information please refer to your device user manual.

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During test execution user interacts with the device using the following commands:
Button Function
Save test in OMNIA (requires PDF generation in PC ECG Stress
software)

6.11.3 Visit Review


ECG Visit Review panel allows to switch between all stress and resting ECG tests
performed during the visit by clicking on ECG Stress @ “time” and ECG Rest @
“time” tabs, respectively. It shows the stored ECG in PDF format. The following
functions are available in addition to those described in section 6.1.3.
Button Function
Edit ECG

6.11.4 Trial Edit


The ECG Edit function automatically opens the PC ECG software where all test
editing can be performed. OMNIA software shows the steps required for test
editing, the software to use for each action and the related buttons.

Note: After test editing a new PDF must be generated in PC ECG software.

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6.12 Body Composition

6.12.1 Real-time Interface


The real-time interface allows to perform a complete body composition test, which
includes 1 mass measurement and 2 to 3 volume measurements and, if available
and selected, a TGV measurement. The real-time workflow is designed to guide the
user through the entire test with visual and procedural instructions.

6.12.2 Visit Review

In ADP Visit Review panel, results show the best test performed during the visit and
includes a distribution curve relative to the population selected for %Fat and
graphical trends for %FFM, Fat Mass, Fat Free Mass, and Body Mass. Numerical
results are shown to the right.
The following functions are available in addition to those described in section 6.1.3.
Button Function
Export test in Excel format

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6.12.3 Trial Edit


In ADP Edit panel users can select the body density model from the dropdown,
modify population distribution by indicating if the subject is an athlete and choosing
the appropriate sport and position (if available). The Edit panel also allows to select
the Thoracic Gas Volume Model and to edit the measured TGV by clicking on . If
multiple TGV trials were performed, the TGV Edit panel allows to accept/discard and
show/hide individual trials by selecting or deselecting the corresponding
checkboxes and radio buttons, respectively. Two graphs (TGV values and chamber
and airway pressures against time) are shown to the left. Single TGV trials can also
be edited after clicking on the corresponding icon and can be navigated through
the left/right arrows. A single trial Edit panel opens and allows to accept/discard the
trial and to modify the time interval for TGV calculation. The time interval can be
adjusted by moving the two red dashed lines directly on the graph or by moving the
slider below the graph. The following functions are available in addition to those
described in section 6.1.4.
Button Function
Full Calc Calculate TGV using the entire time interval
Auto Calc Calculate TGV using an automatically selected time interval

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7 - Calibration

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7.1 Overview

Regular calibration is necessary to ensure the system is acquiring reliable


measurements. Calibration functions are accessible by clicking the Calibration tile
from the Home panel of OMNIA. Refer to the diagram below to access the required
calibration. Refer to section 1.3 to check if your device can be calibrated using
OMNIA.

Note: Calibration functions visibility depends on software and hardware


configuration (refer to section 1.4).

Note: For information on hardware components required for Calibration,


calibration warm-up and time intervals refer to your device user manual.

Flowmeter Calibration DLCO Calibration

Air Calibration
Calibrate Scale
N2 Washout - Air
X9 Linearization Table
Calibration
Gas Calibration N2 Washout
Calibration
Polytropic Factor
Metabolic
Calibration Calibration-ERGO
Mixing Chamber Flowmeter
Calibration
Metabolic
Calibration-ICU
I2m calibration

Q-i2m
Characterization
Q-i2m Calibration
Q-i2m Calibration
Calibration History
Q-i2m Filter
Characterization

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7.1.1 Real-time Interface


The following functions are displayed during calibration execution:
Button Function
Start a new calibration

Restart the calibration without saving

Cancel the calibration

End the calibration

Exit from the calibration real-time interface

For calibration-specific functions or exceptions please refer to the relevant


calibration section.

7.1.2 Calibration Results


At calibration end a window shows the overall Pass/Fail result with the ability to see
additional information by clicking the Show Details checkbox. These may
comprehend a graphical view of the calibration and measured numerical results for
the calibration parameters with the acceptable ranges and the values obtained
during the last calibrations.
For calibration-specific functions or exceptions please refer to the relevant
calibration section.
All calibrations performed with OMNIA are listed in the Calibration History.

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7.2 Flowmeter Calibration

Flowmeter calibration consists in comparing a known volume of air (calibration


syringe) to the one measured by the system by calculating the correction factors
(expiratory and inspiratory gains). The use of a certified 3-liter calibration syringe is
recommended. If a different syringe volume is used, the value must be entered in
the software (see section 4.4.1). To perform flowmeter calibration refer to your
device user manual. If multiple devices and flowmeters are connected and default
device and flowmeter have not been selected in the Device Manager for flowmeter
calibration (refer to section 9.5) they must be entered at calibration start.

Note: At calibration start, user must confirm whether the flowmeter is connected
to the breathing valve. Calibrations with the breathing valve only compute
the calibration parameters to apply to tests using the breathing valve.

The following functions are available during calibration execution in addition to


those described in section 7.1.1.
Button Function
Zeroing the X9 PNT flowmeter sensor. Make sure there is no air flow
through the X9 PNT while using this function

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7.3 Calibrate Scale

Scale calibration is required for the BOD POD device to ensure accuracy of
measurements. To perform scale calibration, refer to your device user manual. On-
screen instructions, which ask to place and remove the reference calibration
weights from the scale repeatedly, are provided during calibration.
The following functions are available during calibration execution in addition to
those described in section 7.1.1.
Button Function
End calibration and save results

At the end of calibration, calibration details show measured numerical results along
with the acceptable ranges and a Pass/Fail result is shown to the right.

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7.4 X9 Linearization Tables

X9 Linearization tables allow to create a new or import an existing linearization


table (stored on included USB drive, identified by Serial Number) for X9 PNT.
Linearization tables are specific for every X9 PNT. If the X9 PNT is changed, new
linearization tables must be imported or created. Periodical flowmeter linearization
is recommended to enhance the accuracy of the X9 PNT flowmeter, whose
characteristics may vary over time.
The following functions are available in the linearization table panel in addition to
those described in section 7.1.1.
Button Function
Zeroing the X9 PNT flowmeter sensor. Make sure there is no air
movement through the X9 PNT while using this function

Import an existing linearization table (stored on PC or included with X9


PNT)

Upload/Import a Linearization Tables


To upload/import a linearization table refer to your device user manual. Existing
linearization tables can be imported by entering the X9 PNT Serial Number and
selecting the linearization table file name from the corresponding dropdown in the
pop-up.

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Create a Linearization Table


To create a new linearization table refer to your device user manual. The new
linearization table can either update a previous table for increased accuracy or can
be created from scratch. The creation of the linearization table involves two phases
(Phase 1 and Phase 2). Each phase is indicated by a set of LEDs to the right and
every LED indicates the linearization status at the corresponding flow rate (a green
LED indicates a Pass result). The Phase 1 requires to perform at least 5 strokes using
the syringe, as indicated by the message at linearization start. After the completion
of Phase 1 the Phase 1 set of LEDs disappears and the Phase 2 automatically starts.
During this phase, performing multiple strokes results in higher accuracies.

Note: At calibration start, user must confirm whether the X9 is connected to the
breathing valve. Calibrations with the breathing valve only compute the
calibration parameters to apply to tests using the breathing valve (two
separate linearization tables are created for the X9 with/without the
breathing valve).

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7.5 Gas Calibration

Gas calibration procedures consist of multiple points calibrations: room air and
known reference calibration gas mixtures from certified gas cylinders. Air calibration
is the only single-point calibration. To calibrate Gas Analyzers refer to your device
user manual. Gas cylinder concentration values and O2 sensor span can either be
edited at calibration start or in Settings/Calibration (refer to section 4.4.2).
During calibration procedures actual concentrations are plotted together with the
expected values, as shown in the example below.
At calibration end, details of the calibration (including measured parameters and
normal ranges) can be visualized by clicking on the Show Details checkbox.

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7.6 Polytropic Factor

Polytropic Factor calibration is required by the Q-Box to ensure accurate


measurements. Multiple air expansion and compression processes, which are
operated by a pump that delivers known volumes of air into the box, allow to relate
pressure changes with volume changes, and therefore to calculate the polytropic
factor. A correction is applied to the polytropic factor as a function of the subject’s
body weight during test execution.
To perform a Polytropic Factor Calibration refer to your device user manual.

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7.7 Mixing Chamber Flowmeter Calibration

The mixing chamber flowmeter calibration is a flowmeter calibration performed


with a mixing chamber setup. The procedure for Mixing Chamber Flowmeter
Calibration is identical to the flowmeter calibration mentioned in section 7.1.1,
however, the parts are assembled differently. To perform the Mixing Chamber
Flowmeter Calibration refer to your device user manual.

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7.8 I2m Calibration

I2m calibration is required by the Quark i2m device to ensure accurate impedance
measurements. A reference impedance is used through which the system sends a
PRN (Pseudo-Random Noise) signal. Flow and pressure are shown in the real-time
interface during i2m calibration. Impedance readings are performed and correction
factors are then calculated to match the reference impedance value.
The loudspeaker signal level and impedance value can be edited in
Settings/Calibration (refer to section 4.4). To perform i2m calibration refer to your
device user manual.

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7.9 Q-i2m Calibration

7.9.1 Q-i2m Characterization


Q-i2m characterization is required by the Q-i2m to characterize the impedance
response of the whole system when an infinite resistance is applied. A plug is used
to mimic an infinite resistance load. Flow and pressure are shown in the real-time
interface during Q-i2m characterization. To perform Q-i2m characterization refer to
your device user manual.

7.9.2 Q-i2m Calibration


Q-i2m calibration is required by the Q-i2m to ensure accurate impedance
measurements. A reference impedance (FOT calibrator) is used through which the
system sends a PRN (Pseudo-Random Noise) signal. Flow and pressure are shown in
the real-time interface during Q-i2m calibration. Impedance readings are performed
and a calibration function is calculated.
To perform Q-i2m calibration refer to your device user manual.

7.9.3 Q-i2m Filter Characterization


Q-i2m filter characterization is required by the Q-i2m to characterize the filter
impedance if filters different from COSMED filters with oval mouthpiece are used
during testing. Flow and pressure are shown in the real-time interface during Q-i2m
filter characterization.
To perform Q-i2m filter characterization refer to your device user manual.

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7.10 Calibration History

OMNIA maintains a record of all calibrations performed using the software. This can
be from a single or multiple devices. Calibrations can also be manually added to the
record by clicking on : a window opens and asks to select device, serial number,
calibration type, flowmeter and measured calibration parameters.

Manually inserted calibrations are particularly useful for certified calibration data
entry, whenever it is not possible to perform the calibration directly from OMNIA or
to automatically transfer the calibration information to OMNIA.
All calibrations are listed along with the device information and the overall
calibration result (Passed, Failed and Accepted, Manual). If no calibration result is
shown default settings are applied to the calibration.
The following functions are displayed in the Calibration History panel:
Button/Dropdown Function
Filter On Filter calibrations by date
Select Device Filter calibrations by device
Serial Number Filter calibrations by serial number
Calibrations Show/hide record of calibrations
QC Show/hide record of quality controls

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For each calibration the following functions are also available:


Button Function
Open calibration

Edit calibration results

Print calibration results

Export calibration

Restore default settings

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8 - Quality Control

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8.1 Overview

Quality Control is used to validate that the device is within calibration limits and as
an advanced tool to assess a good performance of the device.
Quality Control functions are accessible by clicking on the Quality Control tile from
the Home panel of OMNIA. Refer to the diagram below to access the required
function.

Note: Quality Control functions visibility depends on software and hardware


configuration (refer to section 1.4).

All quality control procedures performed with OMNIA, except for those executed in
the Control Panel, are listed in the Calibration History.

Note: For information on hardware components required for Quality Control


procedures, please refer to your device user manual.

Flowmeter Verification Scale Check


Autorun
Leakage Check
Volume Check
Quality Control BOD POD QC Autorun-6X

Practice Subject
Control Panel Measurements
Export QC
QC History

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8.1.1 Real-time Interface


The following functions are displayed during quality control execution:
Button Function
Start a new quality control

Restart the quality control without saving

Cancel the quality control

Exit from the quality control real-time interface

For quality control-specific functions or exceptions please refer to the relevant


quality control section.

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8.2 Flowmeter Verification

Flowmeter verification is used to check the flowmeter response at multiple pre-


defined flow rates, using the gains (correction factors) stored at the end of the
previous calibration. Verification differs from calibration because it does not
calculate the gains for matching the measured and the actual volumes and flows,
but it is used to validate that the device is within calibration limits.
To perform Flowmeter verification, refer to your device user manual. If multiple
devices and flowmeters are connected and default device and flowmeter have not
been selected in the Device Manager for flowmeter verification (refer to section
9.5) the device and the flowmeter must be entered at verification start. Users can
also select if the flowmeter is attached to the breathing valve at verification start. A
set of leds is shown to the right and every LED indicates the verification status at the
corresponding flow rate (a green LED indicates a Pass result).
Each stroke is numerically displayed including relative error according to the
following color code:
Green: Stroke is accepted (both flow and volume in the acceptable range).
Only the first accepted stroke for each check appears in green.
Black: Stroke is accepted, however there is another accepted stroke in this
flow range or the flow is outside verification range.
Red: Stroke volume is outside the acceptable range according to the
Flowmeter verification settings.
The following functions are displayed in addition to those described in section 0:
Button Function
Stop calibration (data are stored even if all the checks are not
completed)

Accept calibration

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8.3 Leakage Check

Leakage Check is an operation which is performed to check seal of the Q-Box and
controlled leaks. It calculates peak pressure and leakage time (i.e., depressurization
time delay from peak pressure) after Q-Box pressurization.
To perform a Leakage Check, refer to section 4.5.2 and to your device user manual.
The check is automatic after Start is pressed.

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8.4 Q-i2m Test Load

Q-i2m test load is used to check Q-i2m impedance readings. A reference impedance
(FOT test load) is used through which the system sends a PRN (Pseudo-Random
Noise) signal. Flow and pressure are shown in the real-time interface during Q-i2m
test load.
To perform Q-i2m test load refer to your device user manual.

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8.5 BOD POD QC

On screen-instructions are provided for all BOD Pod quality controls. The following
functions are displayed during BOD POD quality control execution:
Button Function
Proceed to the following step

Go to previous step

8.5.1 Scale Check


The scale check is used to assess the performance of the BOD POD scale. To perform
the scale check refer to your device user manual. On-screen instructions, which ask
to place and remove the reference calibration weights on the scale repeatedly, are
provided during scale check.
The following functions are displayed in addition to those described in section 0:
Button Function
Perform a scale check

At scale check end the measured weight is shown along with a Pass/Fail result to
the right.

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8.5.2 Autorun
The Autorun is used to assess environmental and BOD POD stability and consists of
six sequential automatic measurements. To perform the Autorun refer to your
device user manual. During the Autorun individual measurements are plotted and
linearly fitted. At autorun end the measurements average and the fitting standard
deviation and slope are shown to the right along with a Pass/Fail result.

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8.5.3 Volume Check


The Volume Check is used to assess volume performance, i.e. to assess the
reproducibility of volume measurements. To perform the volume check refer to
your device user manual. On-screen instructions, which ask the user to open and
close the BOD POD door repeatedly and to click Next after each step, are provided
during volume check. During the Volume Check individual volume measurements
are plotted and linearly fitted. At Volume Check end the measurements average and
the fitting standard deviation are shown to the right along with a Pass/Fail result.

8.5.4 Autorun-6X
The Autorun-6X activity takes one-hour, but can be stopped early, and consists of
six sequential Autorun sequences with a five-minutes break between. This is used
to warm-up the BOD POD prior the routine QC activities. To perform the autorun-6X
refer to your device user manual. Intermediate and final results are displayed. The
following functions are displayed:
Button Function
End Autorun-6X and save results

During the Autorun-6X individual autorun measurements are plotted and linearly
fitted. At Autorun-6X end all the autoruns performed are plotted and listed along

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with averages, standard deviations and slopes. The average of the autorun averages
and the standard deviation and slope of the autorun averages fitting are shown to
the right along with a Pass/Fail result.

8.5.5 Practice Subject Measurements


Practise Subject Measurements functions are used to familiarize with the test steps
prior to performing the actual test.
Practice Mass
Practice Mass allows for the measurement of a subject’s body mass without
performing a complete body composition test.
Practice Body Volume
Practice Body Volume allows for the measurement of a subject’s body volume
without performing a complete body composition test. Results are not provided at
the end of the procedure.
Practice TGV
Practice TGV allows for practicing the measurement of a subject’s thoracic gas
volume without performing a complete body composition test. Results are not
provided at the end of the measurements.

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8.5.6 Export QC
Export QC allows to export BOD POD QC results to a comma delimited file (required
for troubleshooting). To export QC click Save, select folder and click Finish.

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8.6 Control Panel

Control Panel is an advanced diagnostic tool for users with an understanding of the
device measurement technology. It allows to monitor several different parameters.
Name, real-time value, unit of measurement and acceptability range (Min, Max) are
shown for each parameter. By checking the Enabled checkbox, the corresponding
parameter can be enabled/disabled for graphical visualization, which can be
configured by selecting the Y-axis from the Show dropdown (time is represented on
the X-axis). The real-time graph allows to plot up to two parameters from the list.
The enabled parameters can be recorded and saved in a text file by clicking
below the parameters list and choosing location and file name. Users can also adjust
the parameters update interval by moving the slider below the graph.
Two different control panels are displayed depending on the device used.
The first control panel below shows the list of parameters to the left and the real-
time graph to the right.

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Button Function
Begin data display

Toggle between raw data (millivolts) and calibrated data (um)

Select all parameters

Uncheck all parameters

Exit data display/acquisition

Toggle to record the enabled parameters. Data are automatically


stored in the selected File Name as a text file

Reset parameters (Min and Max) to baseline values

Edit chart: choose time, range of acceptability (Min, Max), step, auto
scale and to show the Y-axis for Y1 and Y2

Clear graph

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The following control panel shows the list of parameters to the left, the real-time
graph and a window with additional commands to the right.

Button/Command Function
Begin data display

Toggle between raw data (millivolts) and calibrated data (um)

Select all parameters

Uncheck all parameters

Exit data display

Toggle to record the enabled parameters. Data are automatically


stored in the selected File Name as a text file

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Reset parameters (Min and Max) to baseline values

Configure the chart: choose time, range of acceptability (Min,


Max), step, auto scale, to show the Y-axis for Y1 and Y2

Clear graph

Flowmeter Select flowmeter from the dropdown


Cylinders Toggle the active gas cylinder
Valves Activate internal valves
Breathing Valve Control breathing valve opening (off, open, occlusion) and specific
operations:
Purge: toggle to purge the breathing valve system
P0.1 Shut Test: activate shutter closure for 0.1 s
Body-Box Activate Body Box functions:
Off
Sinusoidal Pump: activate sinusoidal pump
Pressurize (Leakage Check): pressurize body box to check
seal
Vent Valve: activate vent valve
Sampling Pump Activate and adjust speed of sampling pump:
Off
Low Speed
High Speed: for DLCO test only
Sensors Assess sensors functions:
CO/CH4: toggle to activate sensor
O2 Range: adjust O2 span according to sampled gas
Dosimeter Activate dosimeter module and adjust actuation time
Hardware Choose a connected external device to check communication ports
Trimmers Adjust digital trimmers for gas sensors/canopy blower

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8.7 QC History

OMNIA maintains a record of all quality controls performed using the software. This
can be from a single device or multiple devices. In the Network version of OMNIA,
this record will contain all quality controls performed on the network.
All quality controls are listed along with the device information and the overall
quality control results.
The following functions are displayed in the QC History panel:
Button/Dropdown Function
Filter On Filter quality controls by date
Select Device Filter quality controls by device
Serial Number Filter quality controls by serial number
Calibrations Show/hide record of calibrations
QC Show/hide record of quality controls

For each quality control the following functions are also available:
Button Function
Open quality control

Edit quality control results

Print quality control results

Export quality control

Restore default settings

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9 - Utility

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9.1 Overview

Utility functions are accessible by clicking on the Utility tile from the Home panel of
OMNIA. Refer to the diagram below to access the required function.

Note: Utility functions visibility depends on software configuration (refer to


section 1.4) and on rights granted to the logged user (refer to section 9.6.3).

Customize

Metabolic Protocols

Broncho-Challenge Protocols

Training Zones Protocols

Device Manager Change Password

Utility User Accounts Users Management

Backup Database Roles Management

Restore Database

Import Data from CSV

Event Log

Audit Log

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9.2 Customize

The customize panel allows to customize test reports and dashboards. It contains six
tabs: Header, PFT, CPET, REE, ADP, Trends.

9.2.1 Customize Header


The Header tab in Customize panel allows to customize the header of printout
reports. OMNIA allows to change the printout header lines and the logo, that can be
uploaded by clicking on the icon . Only bitmap (*.bmp, *.dib, *.rle), JPEG (*.jpg,
*.jpeg, *.jpe, *.jfif), *.gif, *.tif, *.tiff and *.png files can be selected. Each field can be
customised by right clicking on it: the software allows to select, add, delete fields
and change font. Name, ID1, D.O.B., Gender, Age, Weight and Height fields cannot
be deleted from the header configuration and are used as header on secondary
pages in case of multi-page printouts. A preview of the printout header is shown.
OMNIA updates the header after clicking on Save.

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9.2.2 Customize PFT


The PFT tab in Customize panel allows to customize the appearance of PFT tests
results, Test Edit panels, Visit Review panels and printouts (refer to section 6.1 for
further details).

Parameters Selection
All PFT tests are listed in the Test type column and the complete set of test-specific
parameters is shown for the selected test. By checking the Print, Results, Edit and
Overview checkboxes the corresponding parameter is shown/hidden in test
printouts, Visit Review test panel, Test Edit panel and Visit Review Overview panel,
respectively.
Measured values are always shown and users can choose to show/hide normal
ranges, predicted values, % of predicted values and z-scores by checking the
corresponding checkboxes. Users can also drag and drop the rows and the columns
to modify the arrangement.
Print Options
For each test users can customize the following print options by selecting the
corresponding checkboxes:

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Option Description
Select charts appearance on report printout:
None: hide charts from printout
Charts Default: select default charts appearance
Occupational Health: select occupational health charts
appearance
Show/hide best FVC and additional 2 trials on report printout (FVC
Best FVC + 2 trials
only)
Show/hide volume chart on report printout (for DLCO SB, DLCO IB,
Volume chart
N2 MBW)
Gas vs Volume Show/hide gas-volume chart on report printout (DLCO SB only)
Chart
6MWT step detail Show/hide steps detail on report printout (6MWT only)
Show/hide gauges (graphical bars with predicted range and
Gauges
measured values), if available, on report printout
QC Show/hide quality control on report printout
Trial Results Show/hide results of performed trials on report printout
Tabular Data Show/hide tabular data on report printout
Z-score Format Set z-score format on report printout as:
Both: z-score values and bars on report printout
Value only: z-score values on report printout
Bar only: z-score bars on report printout

Details
Option Description
Device Show/hide device type and S/N on report printout
Test Show/hide test information on report printout
Calibration Show/hide calibration data on report printout
Environment Show/hide environmental data on report printout

The following functions are also available:


Button Function

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Open a preview of selected test report

Restore report to default settings

Note: A complete set of functions is shown. Some PFT tests may have a subset of
such customising options.

The resulting report printout is organized as follows: the header fields are in white
(complete or partial fields are shown depending on the report page, see section
9.2.1), below details are shown in grey. Below the details, charts and gauges are
shown according to test type and further below numerical data, QC and trial results
are shown.

9.2.3 Customize CPET


The CPET tab in Customize panel allows to customize the appearance of CPET tests
results, Test Edit panels, Visit Review panels, dashboards and printouts (refer to
section 6.1 for further details). It contains three tabs: Results, Dashboards, Reports.
Results
Summaries
The appearance of the Summary section of the Results tab of the Visit Review
CPET panel can be customized here. The user can create and save multiple
Summaries, listed to the left.

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The following functions are available:


Button Function
Create a new summary

Rename selected summary

Set selection as default summary

Delete selected summary (not available for standard summaries)

Parameters Selection
The complete set of CPET parameters, grouped by type, is shown.
By checking the Results and Overview checkboxes the corresponding parameter
is shown or hidden in the Summary section of the Results tab of the Visit
Review CPET panel and in the Visit Review Overview panel, respectively.
Measured values, first threshold (VT1/LT1) and maximum values are always
shown and users can choose to show/hide values during rest and warm-up
phases, FatMax, second threshold (VT2/LT2), predicted values, % of predicted

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values, normal values and class by checking the corresponding checkboxes.


Users can also drag and drop the rows and the columns to modify the sort
order of parameters and properties, respectively.
Summary Options
By checking the PRE-Exercise Spirometry checkbox in the lower-left corner the
pre-exercise spirometry parameters are shown in the Summary section of the
Results tab of the Visit Review CPET panel.
Dashboards
Real-time and Results dashboards are customisable by clicking on CPET Dashboards
tab.

All dashboards (standard and customized) are listed to the left and the selected one
is shown in the panel. Dashboards can be ordered by drag and drop. Dashboards
may contain charts (number varies according to the dashboard template), tabular
data at the bottom and main parameters to the right (only available in real-time).
The following functions are available:
Button Function
Create a new dashboard

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Rename selected dashboard

Restore dashboard to default

Delete selected dashboard (not available for standard dashboards)

To create a new dashboard:


Click on New (see button above).
Choose template: user can decide to show/hide charts and/or data by
checking the corresponding checkboxes. An existing dashboard can be used
as template by selecting the Clone Dashboard checkbox and selecting the
template dashboard name from the dropdown.
Name the dashboard and click OK to continue.
Define dashboard options, charts, tabular data and main parameters (see
sections below) and click Save.

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Dashboard Options
Dashboard options in the lower-left corner allow to select the dashboard type
for the selected dashboard and to configure it as Real-time, Results (shown in
the Dashboard tab of the Visit Review CPET panel) or Any (configured both as
Real-time and Results).
Charts
Each chart can be customized through the following functions:
Button Function
Select parameters to view on the chart. Standard graphs can be
selected or alternatively Edit Chart is available to customize graph

Set graph Y-scale according to VEmax. Autoscale and different


VEmax values are available

Maximize graph

By selecting Edit Chart function after clicking on the following window


opens:

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It is possible to select up to 4 y-axis (Y1, Y2, Y3 and Y4) in order to plot up to 4


parameters vs. a single parameter (X). Users can customize the following fields
and options:
Field Function
Parameter Choose the parameter to plot
Autoscale Choose if the graph scale must be automatically set
Show Major Show/hide the main grid in the graph
Grid
Show Minor Show/hide the secondary grid in the graph
Grid
Set the minimum value of the Y-axis (enabled only if Autoscale is
Min Scale
unselected)
Max Scale Set the maximum value of the Y-axis (enabled only if Autoscale is
unselected)
Show Normal Show/hide the normal range on the graph. Normal range will be
Range shown only if available for the selected parameter.
Resolution Set the resolution of the main grid
Style Set the plot aspect
Color Set the plot color
Thickness Set the plot thickness
Hide Recovery Hide/show the recovery phase in the charts
Square Chart Set a squared aspect ratio on charts
Ignore 0 Ignore zero values for plot purposes
Show Events Show/hide events captured throughout the test on charts
Show key Show/hide main parameters determined through calculation (e.g.
variables VT1/LT1, VT2/LT2, etc.) on charts
Show Phases Show/hide the color of the different phases on charts
Set Scale Set Y-scale of the parameters depending on VE according to the
according to VE estimated VEmax which can be set by means of the cursor.

Tabular data
Tabular data are listed below the charts and contain measured values of
selected parameters for the entire duration of the test.
To customize tabular data:

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Click on next to tabular data box on the dashboard panel.


Parameters are divided by type. Check the checkboxes to show/hide the
corresponding parameters from the tabular data.
Click OK to save changes.
Main parameters
Main parameters are shown to the right. The following function is available:
Button Function
Add new main parameter from the list of all available parameters.
Parameter and label color can be customised by clicking on the
button. The button can be scrolled to be resized

Reports
CPET report printouts are customisable by clicking on Customize CPET Reports tab.

Reports (standard and customized) are listed to the left and the selected one is
shown in the panel. Users can select:
the results to show on report choosing among the list of Summaries
defined in the Results tab.
up to two dashboards to show on report choosing among the one defined
in the Dashboard tab.

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the tabular data to show on report choosing among the one defined in the
Dashboard tab.
The following functions are available:
Button Function
Create a new report template

Rename selected report

Set selection as default report

Delete selected report (not available for standard reports)

Open a preview of selected test report

Restore report to default settings

Print Options
Users can customize the following print options by selecting the corresponding
checkboxes:
Option Description
Show/hide gauges (graphical bars with predicted range and
Gauges
measured values), if available, on report printout
Page Set vertical or horizontal page orientation
Orientation
ABG Show arterial blood gases (ABG) values on report printout
F/V loops Show/hide flow-volume loops on report printout
O2 Kinetics Show/hide O2 kinetics on report printout
Steady State Show/hide Steady State analysis on report printout

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Training Zones
Option Description
Zones Show/hide training zones on report printout
Description Show/hide training zones description on report printout

Details
Option Description
Device Show/hide device type and S/N on report printout
Test Show/hide test information on report printout
Calibration Show/hide calibration data on report printout
Environment Show/hide environmental data on report printout
Protocol Show/hide information about the protocol used

The resulting report printout is organized as follows: the header fields are in white
(complete or partial fields are shown depending on the report page, see section
9.2.1), below details are shown in grey. Below the details, the dashboard and the
results summaries are shown according to the selected report and further below
gauges, F/V loops data and charts and the O2 kinetics are shown. Tabular data are
shown at the end of the report according to the selected report.

9.2.4 Customize REE


The REE tab in Customize panel allows to customize the appearance of REE tests
results, Test Edit panels, Visit Review panels, dashboards and printouts. (refer to
section 6.1 for further details). It contains three tabs: Results, Dashboards, Reports.
Results
Summaries
The appearance of the Summary section of the Results tab of the Visit Review
REE panel can be customized here. The user can create and save multiple
Summaries, listed to the left.

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The following functions are available:


Button Function
Create a new summary

Rename selected summary

Set selection as default summary

Delete selected summary (not available for standard summaries)

Parameters Selection
The complete set of REE parameters, grouped by type, is shown in the Results
tab. By checking the Results and Overview checkboxes the corresponding
parameter is shown/hidden in the Visit Review REE panel and in the Visit
Review Overview panel, respectively. Measured values and % of CV values are
always reported by default and users can choose to show/hide predicted
values, % of predicted values and class by checking the corresponding

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checkboxes. Users can also drag and drop the rows and the columns to modify
the arrangement.
Dashboards
Real-time and Results dashboards are customisable by clicking on REE Dashboards
tab.

All dashboards (standard and customized) are listed to the left and the selected one
is shown in the panel. Dashboards may contain charts (number varies according to
the dashboard template), tabular data at the bottom and main parameters to the
right (only available in real-time).
The following functions are available:
Button Function
Create a new dashboard

Rename selected dashboard

Restore dashboard to default

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Delete selected dashboard (not available for standard dashboards)

To create a new dashboard:


Click on New (see button above).
Choose template: user can decide to show/hide charts and/or data and/or
widgets. A pre-defined dashboard can be selected from the list of standard
dashboards and used as template by selecting the Clone Dashboard
checkbox.
Name the dashboard and click OK to continue.
Define dashboard options, charts, tabular data and main parameters (see
sections below) and click Save.

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Dashboard Options
Dashboard options in the lower-left corner allow to select the dashboard type
for the selected dashboard and to configure it as Real-time, Results (shown in
the Dashboard tab of the Visit Review REE panel) or Any (configured both as
Real-time and Results).
Charts
Each chart can be customized through the following functions:
Button Function
Select parameters to view on the chart. Standard graphs can be
selected or Edit Chart is available to customize graph.

Maximize graph.

By selecting Edit Chart function after clicking on the following window


opens:
custo

It is possible to select up to 4 y-axis (Y1, Y2, Y3 and Y4) in order to plot up to 4


parameters vs. a single parameter (X). Users can customize the following fields
and options:

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Field Description
Parameter Choose the parameter to plot
Choose if the graph scale must be automatically set
Autoscale

Show Major Show/hide the main grid in the graph


Grid
Show Minor Show/hide the secondary grid in the graph
Grid
Set the minimum value of the Y-axis (enabled only if Autoscale is
Min Scale
unselected)
Max Scale Set the maximum value of the Y-axis (enabled only if Autoscale is
unselected)
Show Normal Show/hide the normal range on the graph. Normal range will be
Range shown only if available for the selected parameter.
Resolution Set the resolution of the main grid
Style Set the plot aspect
Color Set the plot color
Thickness Set the plot thickness
Hide Recovery Hide/show the recovery phase in the charts
Square Chart Set a squared aspect ratio on charts
Ignore 0 Ignore zero values for plot purposes
Show Events Show/hide events captured throughout the test on charts
Show key Show/hide main parameters determined through calculation on
variables charts
Show Phases Show/hide phases with colors on charts

Widgets
Widgets allow an easy viewing of some real-time parameters. Each widget can
be customized by clicking on the icon . Six widgets are available for REE
testing and users can select a subset of them, up to a maximum of four, to be
displayed on the dashboard.

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Widget Function

REE AVG: reports the resting energy expenditure, the


respiratory quotient and the percentage of predicted
REE during the averaged REE interval

Variability AVG: reports time and variability of VO2 and


VCO2 which are colored based on the acceptability of
values during the averaged REE interval

Substrates AVG: reports mean values of substrates


(FAT%, CHO%, PRO%) during the averaged REE interval

Breathing pattern (test with mask only): reports


ventilation and respiratory frequency which are colored
based on acceptability

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Dilution (test with canopy only): reports FeCO2, that


must be kept within the acceptability range (green
band). Red and grey bands reflect too low and too high
ventilations, respectively

FiO2 (test on mechanically ventilated subjects only):


reports FiO2 values

Tabular data
Tabular data are listed below the charts and contain measured values of
selected parameters for the entire duration of the test.
To customize tabular data:
Click on next to tabular data box on the dashboard panel.
Parameters are divided by type. Check the checkboxes to show the
corresponding parameters in the tabular data.
Click OK to save changes.
Main parameters
Mian parameters are shown to the right. The following function is available:
Button Function
Add new main parameter from the list of all available parameters.
Parameter and label color can be customised by clicking on the
button. The button can be scrolled to be resized

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Reports
REE report printouts are customisable by clicking on Customize REE Reports tab.

Reports (standard and customized) are listed to the left and the selected one is
shown in the panel. Users can select:
the results to show on report choosing among the list of Summaries
defined in the Results tab
up to two dashboards to show on report choosing among the one defined
in the Dashboard tab
the tabular data to show on report choosing among the one defined in the
Dashboard tab
The following functions are available:
Button Function
Create a new report template

Rename selected report

Set selection as default report

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Delete selected report (not available for standard reports)

Open a preview of selected test report

Print Options
Users can customize the following print options using the corresponding
checkboxes:
Option Description
Show/hide gauges (graphical bars with predicted range and
Gauges
measured values), if available, on report printout
Page Set vertical or horizontal page orientation
Orientation

Details
Device Show/hide device type and S/N on report printout
Test Show/hide test information on report printout
Calibration Show/hide calibration data on report printout
Environment Show/hide environmental data on report printout
Protocol Show/hide information about the protocol used

The resulting report printout is organized as follows: the header fields are in white
(complete or partial fields are shown depending on the report page, see section
9.2.1), below details are shown in grey. Below the details, the dashboard and the
results summaries are shown according to the selected report and further below
gauges and tabular data are shown.

9.2.5 Customize ADP


The ADP tab in Customize panel allows to customize the appearance of Body
Composition tests results, Test Editi panels, Visit Review panels and printouts (refer
to section 6.1 for further details).

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Parameters Selection
The complete set of parameters for body composition is shown. By checking the
Print, Results, Edit and Overview checkboxes the corresponding parameter is
shown/hidden in test printouts, Visit Review test panel, Test Edit panel and Visit
Review Overview panel, respectively.
Measured values are always shown. Users can also drag and drop the rows and the
columns to modify the arrangement.
Print Options
Users can customize the following print options using the corresponding
checkboxes.
Details
Option Description
Device Show/hide device type and S/N on report printout
Test Show/hide test information on report printout
Calibration Show/hide calibration data on report printout
Environment Show/hide environmental data on report printout

The following functions are also available:

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Button Function
Open a preview of selected test report

Restore report to default settings

The resulting report printout is organized as follows: the header fields are in white
(complete or partial fields are shown depending on the report page, see section
9.2.1), below details are shown in grey. Below the details, charts, numerical data
and text explanations are shown.

9.2.6 Customize Trends


The Trends tab in Customize panel allows to customize the appearance of trends
(see section 5.3.5). Trend appearances (standard and customized) are listed to the
left and the selected one is shown in the panel. Trends contain charts and tabular
data at the bottom.
The following functions are available:
Button Function
Create a new trend

Rename selected trend

Set selection as default trend

Restore trend to default

Delete selected trend (not available for standard trends)

Charts
Each chart can be customized through the following functions:
Button Function

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Edit Chart

Maximize graph

By selecting Edit Chart the following window opens:

It is possible to select up to 4 y-axis (Y1, Y2, Y3 and Y4) in order to plot up to 4


parameters vs. time. Users can customize the following fields and options:
Field Function
Parameter Choose the parameter to plot
Autoscale Choose if the graph scale must be automatically set
Show Major Show/hide the main grid in the graph
Grid
Show Minor Show/hide the secondary grid in the graph
Grid

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Set the minimum value of the Y-axis (enabled only if Autoscale is


Min Scale
unselected)
Max Scale Set the maximum value of the Y-axis (enabled only if Autoscale is
unselected)
Label Show/hide the numerical label for each visit on the chart
Show Normal Show/hide the normal range on the graph. Normal range will be
Range shown only if available for the selected parameter.
Resolution Set the resolution of the main grid
Type Set the data type representation:
Lines
Histograms
Style Set the plot aspect
Color Set the plot color
Thickness Set the plot thickness
Value Set type of value to show on the chart:
Measured
% Pred
z score
X Axis Scale Set X-axis (time) scale:
Time Based: visits are spaced according to the execution
dates
Evenly Spaced: visits are evenly spaced, regardless of time
intervals

Tabular data
Tabular data are listed below the charts and contain measured values of selected
parameters. To customize tabular data:
Click on next to tabular data box on the trend panel.
Parameters are divided by type. Check the checkboxes to show/hide the
corresponding parameters from the tabular data.
Click OK to save changes.
Options
Users can customize the following options:
Option Description

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Charts Set the number of charts for the selected trend

Print Options
Users can customize the following print options by selecting the corresponding
checkboxes:
Option Description
Charts Show/hide charts on report printout
Tabular Data Show/hide tabular data on report printout

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9.3 Metabolic Protocols

Metabolic Protocols panel allows to view, customize and create exercise and resting
protocols.

The following functions are displayed:


Button Function
Create a new exercise protocol

Create a new resting protocol

Import an existing protocol (stored on PC)

Edit selected protocol

Duplicate selected protocol

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Export selected protocol

Delete selected protocol

9.3.1 Exercise Protocol


When the Edit button in an existing exercise protocol is pressed or a new exercise
protocol is created, the Protocol Manager panel opens.

Protocol modality, name, type (bike or treadmill) of ergometer and speed/power


unit of measurement can be set in the corresponding fields. Loads are defined by:
Speed and incline for treadmill protocols.
Power for bike protocols.
The Modality field allows to select the protocol modality from the following:
Manual.
Incremental.
Ramp.

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Manual protocols
Manual protocols allow to manually add new steps by clicking on and to enter
data for each protocol step.
Incremental protocols
Incremental protocols allow to customise the following fields:
Button/Field Description
Rest Set data for Rest phase (duration and load)
Warm up Set data for Warm up phase (duration and load)
Exercise Set data for Exercise phase (duration, load and step duration)
Recovery Set data for Recovery phase (duration and load)

Ramp protocols
Ramp protocols allow to customise the following fields:
Button/Field Description
Rest Set data for Rest phase (duration and load)
Warm up Set data for Warm up phase (duration and load)
Exercise Set data for Exercise phase (duration and load)
Recovery Set data for Recovery phase (duration and load)

After protocol configuration, a graph shows the trend of the load. Single steps are
listed below the graph and can be modified by double-clicking on the step. Steps
appear in different colors depending on the protocol phase, as shown below.
Phase Color
Rest Dark yellow
Warm up Light blue
Exercise Green
Recovery Yellow
For each step the user can set the software to automatically start some events (BP,
ABG, ECG, EFVL) by selecting the corresponding checkbox or to delete the selected
step.

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9.3.2 Resting Protocol


When the Edit button of an existing resting protocol is pressed or a new resting
protocol is created, the Protocol Manager panel opens. Resting protocols allow to
determine the Rest intervals for data averaging. Protocol modality and name can be
entered in the corresponding fields. The Modality field allows to select the protocol
modality from the following:
Manual.
Automatic.
Manual protocols
Manual protocols allow to manually add new steps by clicking on and to enter
data for each protocol step.
Automatic protocols
Automatic protocols allow to customise the following fields:
Field Description
Start Time Enter time to start the Rest phase (start of averaging interval)
End Time Enter time to stop the Rest phase (end of averaging interval)

After protocol configuration, the resting intervals are highlighted on a graph. Single
steps are listed below the graph and can be modified by double-clicking on the step.

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9.4 Broncho-Challenge Protocols

Broncho-Challenge Protocols panel allows to view, customize and create protocols


to be used for broncho-challenge tests. All available protocols are listed to the left.
The panel shows the steps and features of the selected protocol.

The following functions are displayed:


Button Function
Create a new protocol

Rename selected protocol

Delete selection (protocol or step)

Add step to selected protocol

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Protocol modality, Broncho-constrictor agent (name and unit of measurement) and


Broncho-dilator agent (name and unit of measurement) can be set in the
corresponding fields.

9.4.1 Protocol Modality


The Modality field allows to select the protocol modality from the following:
Concentration.
Dose.
Exercise.
Dosimeter.
Concentration protocols
Concentration protocols require to enter the agent and the concentration for each
step.
Dose protocols
Dose protocols require to enter the agent and the dose for each step.
Exercise protocols
Exercise protocols require to enter the agent and the duration (Time) of each step.
Dosimeter protocols
Dosimeter protocols require to enter the agent, the nebulizer output, the
concentration, the number of breaths, the actuation time and the dose for each
step.

Note: In Dosimeter modality the default nebulizer output is as defined in OMNIA


Settings.

Steps are colored depending on the administered agent:


Agent Color
Diluent Light blue
Broncho-constrictor Orange
Broncho-dilator Green

Note: Be careful to enter broncho-constrictor values and broncho-dilator values in


agreement with the corresponding unit of measurement.

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9.5 Training Zones Protocols

Training Zones Protocols panel allows to view, customize and create training zones
protocols to be used for CPET tests. All available protocols are listed to the left. The
panel shows the steps and features of the selected protocol.

The following functions are displayed:


Button Function
Create a new protocol

Rename selected protocol

Set selection as default protocol

Delete selection (protocol or zone)

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Add zone to selected protocol

For each training zone the following customization options are available:
Color selection from the dropdown.
Zone name and description entry.
Selection of reference Start Parameter and End Parameter, defining the
zone limits, among the following: VO2 Max, VO2@FatMax, VO2@VT1/LT1,
VO2@VT2/LT2, VO2 Reserve, HR Max.
Zone start and end expressed as a % of the reference parameters (see
above) by means of Start% and End% entry.

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9.6 Device Manager

9.6.1 Overview
The device manager allows to configure all connected devices.

Device Connection
To the left side of the Device Manager panel a list of all COSMED devices that can be
interfaced with OMNIA is shown. The following functions are available:
Button Function
Scan all connected and authorized devices

Open Windows® Device Manager

Open selected device info (a Print button is available)

Upload firmware to selected device

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Speed factor settings: adjust the speed factor of the O2 analyzer on


Quark devices

By default, only the enabled devices are shown. A device is enabled if the
corresponding Enable checkbox is selected. By activating the Show all devices slider,
all COSMED devices are shown.
The communication port for each device can be selected from the Port dropdown. If
communication is successful, by clicking on the Show button software shows the
serial number of the selected device.
Bluetooth® communication is also available for some COSMED devices and can be
enabled from Device Manager panel (see following section for further details).
Test Default Configuration
To the right side of the Device Manager panel the default devices and default
flowmeters can be selected from the dropdowns for each test type. Selecting the
default devices and default flowmeters in the Device Manager allows to skip the
device and flowmeter selection at test start.

9.6.2 Bluetooth® pairing


Bluetooth® Pairing procedure can be executed only after OMNIA is authorized. After
selecting the device from the list of COSMED devices, Discover should be pressed to
initiate the device scan.
For computer pairing requirements refer to your device user manual.

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9.7 User Accounts

9.7.1 Change Password


The Change Password tile is available for all users and allows to change password of
the current user. To change password:
1. Type the old password.
2. Type and confirm the new password, making sure it meets the password
requirements (refer to section 4.9 for further information).
3. Pres Ok to save changes or Cancel to abort.

9.7.2 Users Management


Users Management allows to create, delete and manage users’ information. The
Users Management panel shows the list of all users that can access the software. By
clicking on one user the roles for the selected user are shown on the right. Roles can
be created in Roles Management panel (refer to section 9.6.3 for further details).
The following functions are available:
Button Function
Create new user

Reset password (not available for admin and support)

Edit user information

Delete user (not available for admin and support)

By creating a new user or editing users’ information a window appears which allows
to enter Domain (if the Active Directory is available) and to enter the fields
described below, according to the selected domain.

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For OMNIA local users


Enter Username.
Set if password expires.
Set if user is inactive. Inactive users cannot log in until re-enabled.
Assign role(s) (not available for admin and support).
Enter First Name.
Enter Last Name.
Set if password must be changed at first login.
For Active Directory users
Enter Domain: new users, including first and last name, can be imported by
clicking on and selecting the user from the active directory list. By
clicking on Current user the currently logged user is imported.
Set if user is inactive or not.
Assign role(s) (not available for admin and support).

Note: Active Directory users can access OMNIA with the same username and
password to log in the Active Directory.

Note: OMNIA Network allows to load groups of users from the Active Directory.

9.7.3 Roles Management


Different roles can be assigned to users in order to grant them with a subset of all
possible rights, i.e. to enable users to perform a limited set of actions on the
software. A careful roles assignment is crucial for personal data protection.
Standard roles are Administrator, Technical support, PFT Technician, ADP Technician
and Physician.
Roles Management allows users with roles management right (only Administrator
by default) to add or delete roles and to assign rights to each role. Rights can be
assigned or denied to all roles (except for Administrators and Technical Support) by
selecting or deselecting the corresponding checkboxes to the right.

Note: By default administrators are assigned with all rights except servicing rights.

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The following functions are available:


Button Function
Create new role

Delete role (not available for Administrators and Technical Support)

Roles’ names can be changed by double clicking on the current name and entering
the new one.

Note: Technical Support roles are not allowed to access or modify the database,
except for the DEMO subject, and are only assigned with servicing rights
(e.g. perform calibrations, access the event log, etc.).

In the following table all OMNIA rights are listed:


Right Function
Backup/restore of securables
Delete backup OMNIA DB
Administrator
View Admin tab in Settings
Reset password for OMNIA users
Perform calibrations
Calibration: perform Create/edit/restore calibrations in Calibration
History
Add a new subject
DB: add a subject
Import XML
Perform new test/trial (including offline test)
DB: add and edit a test
Edit test/trial
DB: add and edit a visit Create/edit visit (including previous visit)
DB: advanced edit Metabolic test advanced edit
DB: advanced edit
Metabolic test advanced edit for DEMO subject
DEMO subject
Browse and view subjects (including OCP, HL7®,
DB: browse subjects
DICOM®, GDT, Test download)

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DB: can edit order


Edit visit Order number
number
DB: delete a subject Delete a subject
DB: delete a test Delete a test
DB: delete a visit Delete a visit
DB: edit a subject Edit subjects’ personal data
DB: edit DEMO subject View/Edit DEMO Subject
DB: edit interpretation Edit visit interpretation
DB: edit physician field Visit Review: edit Physician
DB: edit technician field Visit Review: edit Technician
Edit CalibVolume/PediatricCalVol/VolPhantom
General: Technical
in ADP Settings
Support
Calibrate Tidal Volume
View Utility/User Accounts/User Management
Roles: add and edit a
Add/Edit users’ roles
role
Save roles edits
View Utility/User Accounts/User Management
Roles: delete a role
Delete roles
Send data to HIS Send data to HIS
Only NETWORK: Save global settings (saved on DB, read
Settings: Edit global and used by OMNIA clients)
settings In the absence of this right the user views disabled
global settings (not modifiable)
Users: add and edit a View Utility/User Accounts
user Add and edit a user on the Database
View Utility/User Accounts
Users: delete a user
Delete a user
View Utility/Broncho Challenge Protocols
Utility: add br. protocol Add a broncho-challenge protocol (requires
Utility: edit br. Protocol to save)
Utility: backup View Utility/Backup Database
database Backup the database
View Utility/Customize
Utility: create
Create metabolic
customization
summaries/dashboards/reports

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Utility: delete br. View Utility/Broncho Challenge Protocols


protocol Delete a broncho-challenge protocol
Utility: delete View Utility/Customize
customization Delete metabolic
summaries/dashboard/reports
Reset metabolic reports
Utility: edit br. protocol View Utility/Broncho Challenge Protocols
Edit a broncho-challenge protocol
Utility: edit View Utility/Customize
customization Edit metabolic summaries/dashboards/reports
Utility: edit View Utility/Customize
organization Edit printout header (requires Utility: edit
customization to save)
Utility: restore View Utility/Restore Database
database Restore the database
Utility: view audit log View Utility/Audit Log
Export and edit the Audit Log
Utility: view event log View Utility/Event Log
Export and edit the Event Log

Note: Some rights are encapsulated and require other rights to be enabled.

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9.8 Backup Database

Backup Database function is available for OMNIA standalone version only.

Note: A frequent backup is recommended to prevent loss of data (a warning


message prompts at every login after 7 days from the latest backup).

Backup is stored at the following destination:


C:\Users\Public\Documents\Cosmed\CosmedLab\Backups. Destination can be
reviewed in the filesystem by clicking on and old backups can be removed to
free up disk space. Backup files are two (.bak and .logbak). By clicking on Backup the
backup starts and a progress bar shows the operation status.

Note: COSMED assumes no liability for damage or loss of data in the event of
hard drive, PC, external storage damage should occur. To mitigate this risk,
multiple backups should be created and both backup files should be stored
in a safe place (e.g. external hard disk).

Note: For OMNIA network version the database backup is not managed by
OMNIA but the IT department shall perform it on server.

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9.9 Restore Database

Restore Database function is available for OMNIA standalone version only and
allows to restore the database from a previously backed-up file.

To restore a database:
Select a backup file from the list of files in the backup folder (refer to
section 9.7). allows to review the backup folder in the filesystem.
Choose password options (it is possible to keep the current usernames and
passwords or to restore the one of the corresponding selected backup. It is
also possible to reset the Administrator password to the default one).
Press Restore. A progress bar will show the status of the operation.

Note: For OMNIA network version restoring the database is not managed by
OMNIA but the IT department shall restore it from server.

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9.10 Import Data from CSV

Data import from CSV is only available with the optional OMNIA Competitive Data
Import module (refer to section 1.4). It allows to import data from third
manufacturers’ equipment by means of a predefined *.csv (comma separated
values) file which is provided with OMNIA.

Detailed documentation is available by clicking on the icon . Database backup is


recommended prior to CSV data import (refer to section 9.7) and restoring the
database is recommended in case of improper data import.

Note: COSMED does not guarantee the accuracy of the data in the CSV file nor
that the data is compatible with OMNIA database, user must verify the
data contained in the CSV file.

To import CSV data into OMNIA:


1. Select a *.csv file by clicking on the icon .
2. Select the separator used.
3. Press Start. A progress bar will show the status of the operation.
Imported tests are saved in the OMNIA database and are labelled as offline tests
(see 5.3.4 section).

Note: If an error occurs during import in progress no data will be imported in the
OMNIA database.

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COSMED Srl Utility

9.11 Event Log

The Event Log panel shows a record of all events logged by the software which can
be accessed for servicing purposes. Events can be sorted by date, severity (Warning,
QOS, Info, Error), username or machine. Events can be filtered by date by selecting
the day on the calendar and by severity by selecting or deselecting the
corresponding checkboxes. Additional information for each event are shown to the
right side after selection from the Log.

The following functions are available:


Button Function
Delete all Event Log

Export selected event

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Utility COSMED Srl

9.12 Audit Log

The Audit Log panel shows a record of all audits logged by the software. Audits can
be sorted by date, OS logged user, username, machine or audit information. Audits
can be filtered by date by selecting the day on the calendar and by information type
(Logoff, Logon, Information, Success audit) by selecting or deselecting the
corresponding checkboxes. Additional information for each audit are shown to the
right side after selection from the Log.

The following functions are available:


Button Function
Export Audit Log

Delete all Audit Log

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COSMED Srl Resource Center

10 - Resource Center

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Resource Center COSMED Srl

10.1 Overview

Resource Center is a database of custom text strings which the user can directly
access during software navigation to automatically populate certain fields.
This software functionality avoids overtyping, reduces operating time and increases
consistency of stored information.
The following fields can be populated using the resource center database:
Software section Fields
Visit Review Interpretation, Notes
Visit Card Physician, Operator, Grouping
Metabolic Testing Reason for stopping test, Reason for test, Test purpose, Marker
Body Composition Density Model

For each field the user can create new strings by clicking on ; when a string is
selected, it can be modified or deleted by clicking respectively on or .
Interpretation and Notes
When creating a string for Interpretation and Notes, it is also possible to assign a
Tag. When the user wants to use a string from the resource center database to
populate Interpretation and/or Notes within the Visit Review panel, it must click on
(see section 6.1.3). The list of available strings is shown and the Tag can be used
to quickly search for the desired string. Default Notes strings are in agreement with
ATS/ERS guidelines. Placeholders referred to the main test parameters are also
available when creating custom interpretation comments and can be added to the
Description from the list to the right (parameters are listed per test type). When the
interpretation comment is selected in the interpretation field of the Visit Review
panel, the placeholder automatically fills with the numerical value of the parameter,
when available.
Density Model
When creating a Density Model you must enter Name, Fat Density and Fat Free
Mass Density values; the corresponding %fat formula is shown.
The user can choose any custom Density Model when starting a Body Composition
test. The configured Density Model will affect final test results.

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11 - Maintenance
Maintenance COSMED Srl

11.1 Overview

Below is a list of recommended procedures to follow to ensure the data archived in


OMNIA database are always protected and secured and to guarantee you are
getting the best performances out of the software.
Procedure Frequency
Database Backup According to local policy.
High frequency is recommended
Software Upgrade Whenever available
Firmware Upgrade Whenever available
License Upgrade When necessary
Recovery procedures When necessary

Refer to the dedicated subchapters below for procedure details.

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COSMED Srl Maintenance

11.2 Database Backup

Please consider the following statements:


In case of database corruption only a backup copy can restore the database
to a proper functional state.
Even backups can contain corrupted data; it is suggested to create them
frequently so that you can find a working back-up again.
A backup copy kept on the same PC does not save the data in case of
damage to the PC disk; it is therefore suggested to save them on a different
location.
For procedural instructions for database backup refer to section 9.7.

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Maintenance COSMED Srl

11.3 Software Upgrade

New software versions availability is communicated to OMNIA end users via RSS
Feed. Information on latest software version are always available at
www.cosmed.com/update.
You can request your software upgrade by filling the form linked in the RSS Feed or
in the above COSMED website page. Your request will be processed and you will
promptly receive an e-mail from COSMED Support with upgrade eligibility
information and instructions.

Note: It is highly recommended to always backup the database before upgrading.

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COSMED Srl Maintenance

11.4 Firmware Upgrade

For device Firmware Upgrade please refer also to your device user manual. To
install the latest firmware version, make sure OMNIA software version is updated.
To upgrade firmware:
Check www.cosmed.com/update for firmware updates and submit your
upgrade request if necessary.
Download the upgrade file received from COSMED Support and follow the
received instructions.
Connect the device to the PC via a USB cable or a serial connection and
make sure it is powered ON.
Select Device Manager, click on the device you would upgrade and specify
the communication port (USB or COM port).
Click on Upload Firmware and confirm. A progress bar will prompt to
indicate the update status.
When a message of successful upload prompts, click Ok to complete
firmware installation.

Note: The firmware update takes several minutes, DO NOT interact with or power
off the device during the process.

Firmware upgrade for K5 and Q-NRG devices are managed directly on the unit,
without using OMNIA functionality; refer to K5 and Q-NRG user manuals.
Refer also to Device Manager section (Device Connection) for details about how to
update Firmware on the device.

Note: Do not attempt to upgrade firmware without having a valid license. If an


attempt is made, the software and/or device may become inoperable.

Note: It is highly recommended to always backup the database before upgrading.

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Maintenance COSMED Srl

11.5 License Upgrade

Both the OMNIA software and the COSMED device need to be authorized to
operate properly.
Each device may authorize differently, depending on the model and serial number
of the unit. Some devices use license dongles, others communicate directly with the
OMNIA software.

11.5.1 Devices shipped with a license dongle


The devices shipped with a license dongle are paired and will ONLY work together
with an inserted USB dongle which contains the software license.

Note: Dongles are NOT interchangeable, they are associated with specific device
(S/N). The dongle also contains the software and firmware version
authorizations. Do not attempt to update software and/or firmware
without a valid license, otherwise the software and/or the device will
become inoperable.

If a dongle is removed from a computer and inserted into another, close and restart
OMNIA to obtain licenses.

11.5.2 Devices shipped without a license dongle


Devices shipped without a license dongle already arrive authorized by COSMED to
operate with the software version included in the packaging.

Note: The license stored on the device contains the software and firmware version
range for which it is authorized. Do not attempt to update software and/or
firmware without having a valid license. If an attempt is made, the software
and/or device may become inoperable.

11.5.3 License Manager


COSMED License Manager is a program installed by OMNIA located in the COSMED
folder on Start menu; it allows management of devices and dongles licenses.

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COSMED Srl Maintenance

Device Management
Tab Functionality
Device Selection Select the device and the related communication port
Device Information Once a device is selected and powered on, selecting Read
Information: the license information related to the device
are shown; Clear cache* command removes temporary
files on HDD
Upload Firmware Update firmware on the selected device
Upgrade License Upgrade license on the device (HW and/or SW Module);
see below for further details

Note: *Cached files contain information about authorized devices which have
been connected to the computer in the past 30 days. Clearing the cached
files, the 30-day period for this device will end (i.e. an authorized device is
required to open the OMNIA).

Upgrade Device licenses


Connect the device to the PC and power it ON.
Run COSMED License Manager.
Select Device Management.
Select the Device to be upgraded in Device Selection (be sure to select the
correct communication port).
Select Upgrade License and using the button Load from file select the file
(*.lic) received for the update.
Select Upgrade to confirm the operation.
It also possible to manually enter license codes to upgrade license on the
device (be sure to select HW or SW modules).
Dongle Management
Tab Functionality
Read Information Read the information related to the license contained into
the dongle (Model, Device, Serial Number, Software and
Firmware authorized version, Enabled modules,...)
Upgrade License Upgrade license on the dongle (HW and/or SW Module)

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Maintenance COSMED Srl

Upgrade Dongle licenses


Connect the USB Dongle to your PC (be sure to have only the dongle to
upgrade connected! – remove other COSMED dongles not involved in the
upgrade).
Download the file (*.rkl) received for the update to your PC and note the
location.
Open COSMED License Manager.
Select Dongle Management and Upgrade License.
Select Select License.
Select the file (*.rkl) received for the update.

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11.6 Recovery procedures

Note: The following procedures can only be performed by the same Windows®
Administrator who installed OMNIA software and should only be performed
in case of necessity.

11.6.1 Reset Password


Insert the OMNIA installation CD/USB drive.

Note: Use only installation package for the same OMNIA version as the
currently installed one. DO NOT UNINSTALL the software to execute
this task.

Run the executable “setup.exe” file located in the “Omnia folder”.


The files distributed by COSMED are virus-free, any prompt on suspicious
file at this stage can be ignored.
Select Modify from the pop-up screen.
Select Reset Password from the list of options.

11.6.2 Initialize Database


Note: This procedure will erase the current database

Insert the OMNIA installation CD/USB drive.

Note: Use only installation package for the same OMNIA version as the
currently installed one. DO NOT UNINSTALL the software to execute
this task.

Run the executable “setup.exe” file located in the “Omnia folder”.


The files distributed by COSMED are virus-free, any prompt on suspicious
file at this stage can be ignored.
Select Modify from the pop-up screen.
Select Initialize Database from the list of options.

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COSMED Srl Troubleshooting

12 - Troubleshooting

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12.1 Miscellaneous Problems

Recurrent errors not supported by specific messages are reported below together
with the relevant corrective actions:
Problem Cause Corrective Action
After running COSMED DB The selected database has Remove the
Converter, the database is been previously converted arcconverter.log file from
not converted the Suite software
installation folder and try
again
After software installation, Setup installed only the SQL Start again the software
OMNIA icons are not engine setup
created on PC Desktop and
Antivirus blocked the Disable the antivirus and
the Start menu
program installation start the setup again
The SQL (COSMED) service The database is corrupted Reinitialize the Omnia
return errors during the Database and restore a
manual start backup (if any). Refer to
section 11.6.2
The SQL service engine is N/A
corrupted

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12.2 Error Messages and Notifications

While running OMNIA, error messages and notifications may be prompt (usually on
a black vertical bar on the right side of the screen) to report technical failures or
software navigation information. The main and most common messages are
reported in this section.

Note: To solve potential issues, always refer to the instruction included in the
following table (if any). If the problem persists, export the error log (refer to
section 9.10) and contact COSMED Customer Support (see section 13.7.1).

List of error messages


Error # Message Cause Corrective action
0 Error Communication Error Try again
1 “ ”out of range O2 sensor issues Check reference gas
values on the
cylinder label match
the ones reported in
the software.
Check sampling line
integrity and
connection.
Repeat gas
calibration, with a
fresh sampling line, if
available
2 “ ” out of range CO2 sensor issues Check sampling line
integrity and
connection.
Repeat gas
calibration, with a
fresh sampling line, if
available

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4 “ ” instable O2 sensor issues Allow for proper


device warm up
according to the
5 “ ” instable CO2 sensor issues device user manual.
Check gas cylinder
output pressure.
Repeat gas
calibration, with a
fresh sampling line, if
available
6 Calibration gas is absent. Gas not detected Check that the gas
Check calibration tank and cylinder is not empty,
pneumatic circuit set to the correct
output pressure and
opened.
Repeat gas
calibration, with a
fresh sampling line, if
available
7 Volume is out of range The flowmeter reads Make sure complete
<75% or >125% of syringe strokes have
the syringe volume been performed.
indicated in the Visually inspect the
settings. flowmeter for
damages.
Check that the
syringe volume in
settings correspond
to the one reported
on the syringe in use.
18 Communication error. Firmware issues Restart the device
Switch the device OFF/ON
or, if the error persists,
contact COSMED Customer
Support

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19 Communication error. Firmware issues Restart the device


Switch the device OFF/ON
or, if the error persists,
contact COSMED Customer
Support
20 Communication error. Firmware issues Restart the device
Switch the device OFF/ON
or, if the error persists,
contact COSMED Customer
Support
23 Unauthorized function. Disabled firmware N/A
Contact COSMED Customer features
Support
24 E2PROM not responding. Firmware issues N/A
Contact COSMED Customer
Support
26 Task is not allowed. The hardware Restart the device
Hardware cannot be necessary to perform
detected the requested
function is not
detected or present
32 Communication error. Communication Check the
Check the communication cable or general communication cable
cable or, if the error firmware issues
persists, contact COSMED
Customer Support
48 Generic Error. Restart Firmware issues Restart
49 O2/CO2 board error. Board issues N/A
Contact COSMED Customer
Support
50 Valves board error. Contact
COSMED Customer Support
53 Transducers board error.
Contact COSMED Customer
Support

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56 CO gas concentration out Incorrect gas reading Check reference gas


of range values on the
cylinder label match
the ones reported in
the software.
Check that the gas
cylinder is not empty,
57 CH4 gas concentration out set to the correct
of range output pressure and
opened.
Check sampling line
integrity and
connection.
Repeat gas
calibration, with a
fresh sampling line, if
available
58 CO gas concentration Sensor is warming up Allow for proper
instable or is damaged. device warm up
according to the
device user manual.
Repeat gas
calibration, with a
fresh sampling line, if
available
Calibration cylinder is Check that the gas
not set properly cylinder is not empty,
set to the correct
output pressure and
opened.
Repeat gas
calibration, with a
fresh sampling line, if
available

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59 CH4 gas concentration Sensor is warming up Allow for proper


instable or is damaged. device warm up
according to the
device user manual.
Repeat gas
calibration, with a
fresh sampling line,
if available
Calibration cylinder is Check that the gas
not set properly cylinder is not
empty, set to the
correct output
pressure and
opened.
Repeat gas
calibration, with a
fresh sampling line,
if available
60 CO/CH4 board error. Board issues N/A
Contact COSMED Customer
Support
69 Battery low N/A Recharge the
battery or connect
to mains
70 Device busy performing N/A Terminate the
another operation ongoing operation
on the device and
try again

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80 End tidal N2 is out of range N2WO test. Check for breathing


FetN2 <75% or valve leaks.
FetN2 >85% before Make sure enough
O2 delivery time is elapsed since
last N2WO test on
the same subject.
Repeat gas
calibration, with a
fresh sampling line,
if available
81 Inspired O2 concentration N2WO test. FiO2 Check for breathing
is too low <50% after O2 valve leaks.
delivery Check that the O2
gas cylinder is not
empty, set to the
correct output
pressure and
opened.
Repeat gas
calibration, with a
fresh sampling line,
if available

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82 Inspired O2 concentration FiO2<90% or >105% Check for breathing


is out of range after O2 delivery valve leaks.
Check that the
reference gas values
on the cylinder label
match the ones
reported in the
software.
Check that the O2
gas cylinder is not
empty, set to the
correct output
pressure and
opened.
Repeat gas
calibration, with a
fresh sampling line,
if available
83 Inspired CO2 concentration FiCO2>1% after O2 Repeat calibration
is out of range delivery
84 Expired N2 concentration is FeN2 increase >10% Check breathing
too high at each breath valve membrane
during inhalation.
Check the
connection between
breathing valve and
flowmeter or
between the
flowmeter and the
subject
85 A leak has been detected N2 inspiratory
volume >210 ml

96 Unauthorized function. Disabled N/A


Contact COSMED Customer software/firmware
Support features

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Troubleshooting COSMED Srl

97 CO2 sensor error. Contact Sensor issues N/A


COSMED Customer Support
98 CO2 sensor error. Contact Sensor issues N/A
COSMED Customer Support
100 Dosimeter pressure is Pressure noise Check compressed
instable or too low threshold exceeded air connections
or pressure not
detected
102 Dosimeter pressure is out Nebulizer pressure Check compressed
of range out of range air connections
107 CO2 sensor is damaged. Sensor issues N/A
Contact COSMED Customer
Support
108 CO2 gain is out of range Check that the
reference gas values
on the cylinder label
match the ones
reported in the
software.
Check that the gas
cylinder is not
empty, set to the
correct output
pressure and
opened.
Repeat gas
calibration, with a
fresh sampling line,
if available
109 CO2 sensor communication Firmware issues N/A
error. Contact COSMED
Customer Support

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113 Body Box pressure is Do not touch the


unstable Body Box during
test.
Check that the Body
Box door is closed.
Check for quiet
environment (i.e. no
slamming doors,
open windows, etc.)
114 Body Box pressure is taking Pbox rise time Check that the Body
too long to rise exceeds 15s Box door is closed.
Check that the T/RH
probe is properly
inserted in the Body
Box.
Check that the gas
cylinder is not
empty, set to the
correct output
pressure and
opened.
Repeat calibration
115 Body Box pressure is taking Maximum falling Repeat calibration
too long to fall time >20s
116 Body Box pressure is out of The Body Box Repeat calibration
range pressure didn't reach
the expected min
value

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118 Body Box pressure is too Pbox doesn't reach Check that the Body
low. Calibration impossible the 10% of target Box door is closed.
within 6 s Check that the T/RH
probe is properly
inserted in the Body
Box.
Check that the gas
cylinder is not
empty, set to the
correct output
pressure and
opened.
Repeat calibration
123 Motherboard error. Board issues N/A
Contact COSMED Customer
Support
124 Body Box pressure is too Pbox >0.8cmH2O N/A
high
125 Body Box pressure is too Pbox <0.8cmH2O N/A
low
126 Body Box pressure is too N/A
high. Contact COSMED
Customer Support
127 CO2 scrubber is absent or CO2 scrubber not Insert or replace the
expired detected CO2 scrubber
304 Error while loading test. Software issues Try again
Select the test again
312 Error while exporting data Software issues Try again
313 Error while importing data Software issues Try again
353 Error while upgrading the Firmware issues N/A
firmware. Switch the device
OFF/ON and try again

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356 Device not found Communication Check the device is


issues turned on.
Check the device is
properly connected
to the PC.
357 Bluetooth® adapter not Bluetooth® issues Check that the
found Bluetooth® adapter
is connected to the
PC.
Refer to section 12.3
771 Generic Error. Check 'Event Password/license Look for possible
Log' for details issues resolution
information in Event
Log (see section
9.10)
791 Login error: Enter Username and Fill in username and
username and password password are empty password fields
792 Login error: User is inactive The selected user is Change user.
set to “inactive” Log in with
appropriate rights
and re-activate the
user
793 Login error: Invalid Username and/or Correctly fill in
username or password password are not username and/or
correct password fields
800 User cannot login, server Network Check network
not found disconnected during connection and try
first login again
801 No roles are assigned to The selected user has Change user.
this user. User cannot login no roles assigned Log in with
appropriate rights
and re-defined user
role
802 Error while communicating Communication Check network
with the server. User issues connection and try
cannot login again

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804 License is not found. OMNIA USB dongle Check if the dongle
Connect an authorized license is not is correctly plugged
device or a OMNIA detected in the PC USB port.
hardware key Double check trying
a different USB port.
OMNIA onboard Check if the device is
license is not correctly plugged in
detected the PC USB port.
Double check trying
a different USB port.
Check if the
COSMED Device is
present in the
Windows® Device
Manager and if
there are no errors
reinstall the Omnia
Drivers
The serial number of Check serial number
the device is not on the information
detected (devices menu of the device
with onboard license and report it to
only) COSMED Customer
Support.
806 Licence is not valid. Please Software license not N/A
contact Customer Support valid
808 Network License Services Communication Check connection
are unreachable issues with the license
server and try again
816 Server database has a This client version is Upgrade this client
newer version. Update older than server version
Client version or contact version
the Administrator
817 Client has a newer version. This client version is Upgrade server
Update server database older than server version
version or contact the version
Administrator

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820 Unable to load OMNIA, Client and server Align client and
upgrade the Database to versions mismatch server OMNIA
continue versions
822 Database cannot be Existing database Upgrade to an
upgraded to this version. version to old or intermediate
Uninstall OMNIA and install incompatible with the previous version and
a previous version or new one then to the new one
contact COSMED Customer
Support
835 Server Database If “Error: Cannot start Manually start the
unreachable. Error: service SQL (COSMED)
MSSQL$COSMED on service in the
computer”, the SQL Windows® services
(COSMED) service list, if error persists
cannot start. contact COSMED
Customer Support.
If “Error: Login failed Reinitialize the
for user Omnia Database
‘pgmSystem’”, the
database is not
initialized.
1027 Error while updating the Concurrent operation Try again
database. Try again ongoing
1280 Flow out of range Perform syringe
strokes at the
indicated flow
range.
Check flowmeter for
visual damages
1282 Error while processing the Incorrect parameters Try again
data. Restart during operation
1285 Error while uploading the PNT X9 linearization Try again
data. Press YES to retry table issues

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1289 Communication error. Try Communication Restart the device


again or, if error persists, issues while
switch the device OFF/ON operation Control
Panel
1537 Communication error. Try Communication Try again or restart
again or, if error persists, issues while aborting the device
switch the device OFF/ON the test
1538 Noisy flowmeter baseline. Flowmeter baseline Restart the test
Restart instable
1540 Device not found. Press YES Incompatible device From OMNIA Device
to select the correct device or device not Manager, select a
connected device able to
perform the desired
test
1541 Device not authorized. Disabled hardware N/A
Please contact COSMED features
Customer Support
1542 Communication error. Communication From OMNIA Device
Check selected port and try issues Manager, select
again or, if error persists, correct port.
switch the device OFF/ON Restart the device
1543 Communication error. Try Communication Try again or restart
again or, if error persists, issues the device
switch the device OFF/ON
1545 Communication error. Try Device not ready Try again or restart
again or, if error persists, the device
switch the device OFF/ON
1552 Communication error. Communication Check the device is
Check device connection issues turned on.
Check the device is
properly connected
to the PC.

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1585 Error while saving file. Issues while trying to Look for possible
Check 'Event Log' for save customization resolution
details settings information in Event
Log (see section
9.10)
1766 Invalid data. Restart Incorrect parameters Try again
during MIP/MEP test
1782 Communication error. Incorrect parameters Try again
Restart during DLCO test
BTPS correction
1792 The device in use is not User selected a Change protocol or
compatible with the Dosimeter mode select an
selected protocol protocol and the appropriate device
connected device
does not have an
integrated dosimeter
2049 Error while creating report. Issues while creating Look for possible
Refer to 'Event Log' for report resolution
details information in Event
Log (see section
9.10)
2306 Sentence ID not found GDT error Check input file
2307 Sentence ID 8100 not found GDT error Check input file
or not well-formed or
incorrect file size
2308 Sentence ID {0} not GDT error Check input file
handled
2309 Incorrect sentence length, GDT error Check input file
line {0}
2310 Incorrect sentence format, GDT error Check input file
line {0}
2312 No matching Subject GDT error
2313 No matching Visit GDT error
2320 No matching Test GDT error

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65534 Communication error. Try Operation timeout Try again or restart


again or, if error persists, the device
switch the device OFF/ON
65535 Communication error. Communication Check the device is
Check device connection issues turned on.
Check the device is
properly connected
to the PC.

List of notifications
Error # Message Note
25 Device is not ready yet. Warm-up is in Allow for proper device
progress warm up according to
87 CO2 calibration is already in progress the device user manual.

95 CO2 is warming up. Try again later


99 Dosimeter test has exceeded the time Test time
duration duration >3min
307 Are you sure to delete the user? Irreversible operation
308 Are you sure to reset the password for this
user?
321 Are you sure to delete all data for this Irreversible operation
subject?
322 Are you sure to delete all data for this visit? Irreversible operation
324 Are you sure to delete all data for this test? Irreversible operation
326 A subject with similar data already exists. Data won’t be merged
Are you sure to add a new subject?
327 This role is already assigned to existing Unassign the role to
users. Role cannot be deleted delete it
328 File is not supported Use another file format
329 The entered name already exists Protocol names are
unique
337 The protocol “ ” already exists Protocol names are
unique

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338 The file “ ” is not supported


339 Are you sure to delete the protocol? Irreversible operation
340 Are you sure to permanently delete this file? Irreversible operation
341 The test already exists
343 WARNING: Firmware upgrade deletes all Irreversible operation
data stored in the device.
Are you sure to proceed?
354 Connect your device and switch it ON
355 Device not found. Select a device from the For further information
list see section 9.5
360 WARNING: Database restore deletes all Irreversible operation
data.
Are you sure to proceed?
372 Test cannot be performed. A Broncho- Multiple Broncho-
Challenge test for this Subject is already Challenge tests within
being performed the same visit are not
allowed. Complete the
steps of the ongoing
test.
618 WARNING: All audits will be deleted. Are Irreversible operation
you sure to proceed?
368 PC ECG is running in Standalone mode. Click Ongoing PCECG test will
YES to stop the Standalone mode (any test be lost. Irreversible
in progress will be lost) and start the operation
integration with OMNIA
369 Database size is now “ ” % of MS SQL Upgrade to SQL
Express (10GB Max). Upgrade to MS SQL Standard Edition must
Standard Edition for unlimited Database size be handled directly with
Microsoft Support Team
370 “ ” days since the last Database backup Frequent backup is
recommended
768 Password does not match
769 Password cannot be empty
770 Password of an Active Directory user cannot
be changed

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772 New Password is too similar to the current


one
773 User is inactive For further information
see section 9.6
774 Current password does not match
775 User no longer exists in the database
776 Password complexity does not match Policy
defined in Settings:
777 Password does not comply with domain
criteria (bad password)
784 Password does not comply with domain
criteria (too recent)
785 Password not valid (this password has been
already used)
786 Password does not comply with domain
criteria (too short)
787 Password does not comply with domain
criteria (too long)
788 Password does not comply with domain
criteria (too simple)
789 Password does not comply with domain
criteria (change password)
790 Password expired
807 Maximum number of simultaneous Disconnect users or
connected users has been reached purchase additional
licenses
809 Maintenance is being performed on the
Database. Access is denied
818 The Database must be upgraded to the Irreversible operation
newer version. Are you sure to proceed?
819 An error occurred while converting the
Database. The previous Database has been
restored
833 Database Backup required. The backup will
begin

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1024 This record has been modified by another


user. Data will be refreshed. Data editing, if
any, is lost
1025 This record has been deleted by another
user. Data cannot be saved
1026 Database error. Records cannot be updated
1288 Are you sure to restore Default values? Proceeding, any custom
settings must be re-
entered manually
1536 Error while saving the data in the database.
Press YES to retry
1539 The selected device is not recognized. Are The device can get
you sure to proceed with the Firmware inoperable or data can
Upgrade? get corrupted
1544 Bluetooth device not ready. Would you like
to open Device Manager?
1586 Data has been edited, results will be
recalculated. Would you like to save the
changes?
1587 The selected protocol is no longer available The Metabolic protocol
has been deleted/edited
by another users while
operating the software
1588 Uploading Raw Data, results will be Any editing will be lost
recalculated. Are you sure to continue?
1589 Data has been edited, results will be
recalculated. Would you like to save the
changes?
1680 Body Box calibration has not been
performed. Press YES to start calibrating
1695 Close FRC cylinder and press OK to continue
1744 ECG data will not be saved correctly if the
test is still in progress. Are you sure that you
have completed and saved the test in the
PCECG software?

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Troubleshooting COSMED Srl

1745 WARNING: ECG test will not be stored in Irreversible operation


OMNIA Database. Are you sure to abort the
ECG test?
1781 Gas calibration has not been performed.
Press YES to begin calibration
1793 Extra Breath will be administered. Are you Extra agent dose will be
sure to continue? administered to the
subject
1794 {0} breaths remaining. Are you sure to stop The protocol will
the administration of the agent? proceed to the next step
1795 Are you sure to Abort the step? Irreversible operation,
step data will be lost
1796 The selected protocol is no longer available The Broncho-Challenge
protocol has been
deleted/edited by
another users while
operating the software
2305 The file is empty GDT message
2311 Request has been cancelled GDT message

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12.3 Bluetooth® Troubleshooting

K5 and Q-NRG devices can communicate with OMNIA via Bluetooth®.


This wireless communication between can be managed by either the PC internal
Bluetooth® module (when available) or an external Bluetooth® USB Adapter
(hereinafter BTA).

Note: The device can be paired (not simultaneously) with multiple PCs. Moving
the same BTA from one PC to another requires re-pairing process.

If the pairing process between the device and BTA or wireless link fails, please
follow the actions summarized below.

12.3.1 Check for pending Windows® software updates


Check if there any pending Windows® software updates and complete
installation if necessary.
Restart the PC.
Run OMNIA and try the pairing process.

12.3.2 If a BTA is used, be sure that internal Bluetooth® module is


disabled
Refer to your laptop/tablet PC user’s manual to disable internal
Bluetooth®.
Run OMNIA and try the pairing process.

12.3.3 Replace “CSR Bluetooth® Chip” drivers with “Generic


Bluetooth®” drivers
It may occur that during the installation process of the BTA, the operating system
installs a “CSR Bluetooth®” driver rather than the default “Generic Bluetooth®
Radio”.
To Replace USB Drivers
Ensure that the BTA is connected to PC.
Open Control Panel/Device Manager, access Bluetooth® or USB section and
check if CSR Bluetooth® driver is shown (with Warning Symbol).
Right click on CSR Bluetooth® Chip and select Properties.

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Troubleshooting COSMED Srl

Click on Update Drivers.


Select Browse my computer for driver software.
From the list of available drivers select Generic Bluetooth® Radio, click Next
and wait the installation to complete.

Run OMNIA and try the pairing process.

12.3.4 Verify that Bluetooth® Drivers are Properly Installed


To Check Bluetooth® drivers
Ensure that the BTA is connected to PC.
Open Control Panel/Device Manager and access Bluetooth® section.
Verify that the Bluetooth® icon does not show the warning symbol. If so,
please try to reinstall drivers.
To Reinstall Drivers
Right click on the yellow exclamation mark and select UninstaLl.
Disconnect and re-connect BTA to PC.
Wait until BTA is successfully recognized and the Generic Bluetooth® Radio
driver properly installed.
Run OMNIA and try the pairing process.

12.3.5 Uninstall Paired Device


For various reasons it may be required to uninstall previously paired devices to
resolve possible system conflicts.

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To Unpair devices from PC


Ensure that the BTA is connected to PC.
Close OMNIA.
Open Control Panel/Device Manager.
Under View menu enable Show hidden devices.
Under Bluetooth® section look for devices greyed out and uninstall them
with mouse right click.
Disconnect and re-connect BTA to PC.
Restart PC.
Run OMNIA and try the pairing process.

12.3.6 Change the USB port


Plug the BTA into different USB port and restart the PC.
Run OMNIA and try the pairing process.

12.3.7 Check for incompatible or conflicting processes


Some third-party Bluetooth® related processes or services running in background
could interfere with BTA. They should be stopped. Here is a known list of them.
Process Description
Bttray.exe This process is known as Bluetooth® Tray
Application or Bluetooth® Application or
WIDCOMM Bluetooth® Software or BlueSoleil
Bttray or Lenovo Bluetooth® with Enhanced Data
Rate Software
Btvstack.exe This process, also known as Extension Core or
Bluetooth® Stack Server or Bluetooth® Tray, is
developed by Qualcomm Atheros Communications
Inc
ZAtheros Bt and Wlan Coex Agent This service, developed by Qualcomm Atheros
Communications Inc, could prevent BTA driver
loading

End interfering background processes:


Open Task Manager.
Expand Processes menu.

REF C04144-02-91 OMNIA Reference Manual, Edition 15.0 Pag. 277/329


Troubleshooting COSMED Srl

Right-click the interfering process and then click on End task.


End interfering services:
Open View local services.
Under View menu enable Details.
Right-click the interfering service and then click on Stop.

12.3.8 Disable Power Management options


Ensure that the BTA is connected to PC.
Close OMNIA.
From Control Panel select Device Manager.
Under Universal Serial Bus controllers select Generic USB Hub, then click on
Properties.
Under Power Management uncheck Allow the computer to turn off this
device to save power.

Repeat 4-5 for all Generic USB Hub and USB Root Hub.
Run OMNIA and try the pairing process.

12.3.9 Wi-Fi Network Interference


Bluetooth® and Wi-Fi networks share the same frequency range (2.4GHz);
sometimes, even if are both networks designed for coexistence, wireless
interferences may occur. Interferences may arise due to the Wi-Fi radio of the same

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PC where the BTA is installed or a nearby device. Turn off nearby Wi-Fi stations and
verify again the device wireless performance.

Note: You may use a 5GHz Wi-Fi network to resolve possible Wi-Fi interferences

REF C04144-02-91 OMNIA Reference Manual, Edition 15.0 Pag. 279/329


COSMED Srl Appendix

13 - Appendix

REF C04144-02-91 OMNIA Reference Manual, Edition 15.0 Pag. 281/329


Appendix COSMED Srl

13.1 Glossary of Parameters

Complete lists of parameters are shown below per test type, regardless of the
device used. Subsets of such parameters may be visible depending on the device.

13.1.1 Spirometry
Parameter Description Parameter Description
Best FEV1 Best Forced Exp FIV3 Forced Insp. Volume in
Volume in 1 s 3s
Best FVC Best Forced Vital FIV6 Forced Insp. Volume in
Capacity 6s
Best PEF Best Peak Expiratory FIVC Forced Insp. Vital
Flow Capacity
BEV Back Extrapolation FVC Forced Vital Capacity
Volume
BEV/FVC% BEV as % of FVC FVC_QC Quality control grade
referred to FVC
BEV_ins Extrapolated Volume Hesitation Time Hesitation Time
(Insp.)
ChgFEV1 Absolute change in IC Inspiratory Capacity
FEV1 after BD test
ChgFEV1% Relative change in IRV Inspiratory Reserve
FEV1 after BD test Volume
ChgFVC Absolute change in IRV/FVC IRV/FVC
FVC after BD test
ChgFVC% Relative change in FVC IVC Inspiratory Vital
after BD test Capacity
Computer_QC Computer Overall LungAge Lung Age
Quality control grade
Dosimeter Dosimeter Pressure MEF25% Max Exp. Flow @ 75%
Pressure FVC
Effort_QC Quality control grade MEF50% Max Exp. Flow @ 50%
referred to subject s FVC
effort

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COSMED Srl Appendix

EOTV End of test volume, MEF75% Max Exp. Flow @ 25%


expired during last 0.5 FVC
s
ERV Expiratory Reserve MEP Maximal Expiratory
Volume Pressure
ERV/FVC ERV/FVC MIF/MEF50% MIF50%/MEF50%
ratio
EVC Expiratory Vital MIF25% Max Insp. Flow @ 75%
Capacity FVC
FallFEV1 Reduction in FEV1 MIF50% Max Insp. Flow @ 50%
from baseline (FVC Pre FVC
or diluent)
FEF0.2-1.2 Mid-exp. flow MIF75% Max Insp. Flow @ 25%
between 0.2-1.2 L FVC
FEF25-50% Mid-exp. flow MRf Respiratory Frequency
between 25-50%FVC during MVV
FEF25-75% Forced mid-expiratory MVT Tidal volume during
flow MVV
FEF50-75% Mid-exp. flow MVV Maximum Voluntary
between 50-75%FVC Ventilation
FEF75-85% Mid-exp. flow MVVt MVV duration Time
between 75-85%FVC
FET100% Forced Expiratory PC10 Provocative
Time concentration causing
FEV1 to fall 10% from
baseline
FEV0.5 Forced Exp. Volume in PC15 Provocative
0.5 s concentration causing
FEV1 to fall 15% from
baseline
FEV0.5/FVC FEV0.5 as % of FVC PC20 Provocative
concentration causing
FEV1 to fall 20% from
baseline

REF C04144-02-91 OMNIA Reference Manual, Edition 15.0 Pag. 283/329


Appendix COSMED Srl

FEV0.75 Forced Exp. Volume in PD10 Provocative dose


0.75 s causing FEV1 to fall
10% from baseline
FEV0.75/FVC FEV0.75 as % of FVC PD15 Provocative dose
causing FEV1 to fall
15% from baseline
FEV1 Forced Exp. Volume in PD20 Provocative dose
1s causing FEV1 to fall
20% from baseline
FEV1/FEV6% FEV1 as % of FEV6 PEF Peak Expiratory Flow
FEV1/FVC% FEV1 as % of FVC PEFr Peak Expiratory Flow
(L/min)
FEV1/VC% FEV1 as % of VC PEFT Time to PEF (10% to
90%)
FEV1/VCmax% FEV1 as % of VC Max PIF Peak Inspiratory Flow
FEV1_QC Quality control grade PIFT Time to PIF (10% to
referred to FEV1 90%)
FEV2 Forced Exp. Volume in Pred MVV Extimated Maximum
2s Voluntary Ventilation
FEV2/FVC% FEV2 as % of FVC Rise Time 10-90% Rise time
FEV3 Forced Exp. Volume in Te Expiratory time
3s
FEV3/FVC% FEV3 as % of FVC Technician_QC Technician Overall
Quality control grade
FEV6 Forced Exp. Volume in Ti Inspiratory time
6s
FEV6/FVC% FEV6 as % of FVC Ti/Ttot Ti/Ttot ratio
FIF0.2-1.2 Mid-insp. flow Ttot Duration of Total
between 0.2-1.2 L breath during tidal
breathing
FIF25-50% Mid-insp. flow VC Vital Capacity
between 25-50%FVC
FIF25-75% Forced mid-inspiratory VDf Filter Dead Space
flow

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FIF50-75% Mid-insp. flow VDs System Dead Space


between 50-75%FVC
FIF75-85% Mid-insp. flow VDv Valve Dead Space
between 75-85%FVC
FIT100% Forced Inspiratory VE Minute Ventilation
Time
FIV0.5 Forced Insp. Volume in VT/FVC VT/FVC
0.5 s
FIV1 Forced Insp. Volume in VT/Ti VT/Ti ratio
1s
FIV2 Forced Insp. Volume in
2s

13.1.2 Diffusing Lung Capacity


Parameter Description Parameter Description
Breath Hold Breath Hold Time FRC(DLCO) Functional Residual
Time Capacity during DLCO
COHb Carboxyhemoglobin FRC/TLC(DLCO) FRC as % of TLC during
DLCO
Computer_QC Computer Overall Hb Hemoglobin
Quality control grade
CORR COHB CoHB Correction IV(DLCO) Inspiratory Vital
Capacity during DLCO
CORR HB HB Correction KCO DLCO/VA ratio
CORR PA Alveolar Pressure Mouth Pressure Mouth Pressure
Correction
CORR PB Barometric Pressure RV(DLCO) Residual Volume
Correction during DLCO
DLCO 3eq DLCO 3 Equation RV/TLC(DLCO) RV as % of TLC during
DLCO
DLCO corr DLCO Corrected Sample Vol Sample Volume
DLCO PB Diffusion Lung CO (PB Technician_QC Technician Overall
Corrected) Quality control grade

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Appendix COSMED Srl

DLCO pred,adj Diffusion Lung CO TLC(DLCO) Total Lung Capacity


predicted adjusted during DLCO
DLCO unadj Diffusion Lung CO VA Alveolar Volume
unadjusted
DM Membrane Diffusing VC Vital Capacity
Capacity
Effort_QC Quality control grade Vc Blood Volume in
referred to subject’s alveolar capillaries
effort
ERV Expiratory Reserve VCH4 Expired volume of CH4
Volume
FaCH4 CH4 Alveolar VCO Expired volume of CO
Concentration
FaCO CO Alveolar VDa Anatomic Dead Space
Concentration
FetCH4 Breath End CH4 VDa Coeff Anatomic Dead Space
Concentration Coefficient
FetCO Breath End CO VDFowler Fowler Dead Space
Concentration
FiCH4 CH4 Inspiratory VDs System Dead Space
Concentration
FiCO CO Inspiratory VDv Valve Dead Space
Concentration

13.1.3 Body Plethysmography


Parameter Description Parameter Description
Body Box Body Box Pressure Raw exp Expiratory airway
Pressure resistance
Computer_QC Computer Overall Raw ins Inspiratory airway
Quality control grade resistance
Dosimeter Dosimeter Pressure Raw Tot Airway resistance Tot
Pressure
Effort_QC Quality control grade Rf Respiratory Frequency
referred to subject’s
effort

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ERV Expiratory Reserve RV(Pleth) Residual Volume


Volume during Pleth.
EVC Expiratory Vital RV/TLC(Pleth) RV/TLC ratio during
Capacity Plethysmography
FRC(Pleth) Intrathoracic Gas sGaw Specific airway
Volume conductance
FRC(Pleth)/ FRC/TLC ratio during sRaw Specific airway
TLC(Pleth) Plethysmography resistance
IC Inspiratory Capacity sRaw eff Effective Specific
airway resistance
IRV Inspiratory Reserve sRaw exp Expiratory Specific
Volume airway resistance
IVC Inspiratory Vital sRaw ins Inspiratory Specific
Capacity airway resistance
K Polytropic coefficient sRaw Tot Specific airway
(adjusted) resistance Tot
Mean IC Mean Inspiratory Technician_QC Technician Overall
Capacity Quality control grade
PD35 Provocative dose TGV Thoracic Gas Volume
causing sGaw to fall
35% from baseline
PD40 Provocative dose TLC(Pleth) Total Lung Capacity
causing sGaw to fall during
40% from baseline Plethysmography
PD45 Provocative dose VC Vital Capacity
causing sGaw to fall
45% from baseline
PD100 Provocative dose VDs System Dead Space
causing sGaw to fall
100% from baseline
Predicted TGV Predicted TGV VDv Valve Dead Space
Prev. Measured Prev. Measured TGV Voccl Occlusion Volume
TGV
Raw Airway resistance VT Tidal Volume

REF C04144-02-91 OMNIA Reference Manual, Edition 15.0 Pag. 287/329


Appendix COSMED Srl

Raw eff Effective Airway


resistance

13.1.4 Nitrogen Washout


Parameter Description Parameter Description
∆ N2 Delta N2 Rf Respiratory Frequency
CC Closing Capacity RV(N2 WO) Residual Volume
during N2 Washout
CEV Cumulative Expired RV/TLC(N2 WO) RV as % of TLC during
Volume N2 Washout
CFRC Cumulative SIII Phase III Slope
Functional Residual
Capacity
Computer_QC Computer Overall SIII CoV Phase III Slope
Quality control Coefficient of
grade Variation
CV Closing Volume SIII SD Phase III Slope
Standard Deviation
CV/VC(CV)% Closing Volume vs SIIIVC Phase III Slope
VC(CV) Percentage multiplied VC(CV)
Effort_QC Quality control Technician_QC Technician Overall
grade referred to Quality control grade
subject s effort
ERV Expiratory Reserve TLC(N2 WO) Total Lung Capacity
Volume during N2 Washout
FeN2 Fractional V_I Phase One Volume
concentration of
expired nitrogen
FetN2 End tidal fractional V_II Phase Two Volume
concentration of
expired nitrogen
FiN2 Fractional V_III Phase Three Volume
concentration of
inspired nitrogen

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FRC Functional Residual VC Vital Capacity


Capacity
FRC CoV Functional Residual VC(CV) Vital Capacity during
Capacity Coefficient Closing Volume
of Variation
FRC Mean Functional Residual VDFowler Fowler Dead Space
Capacity Mean
FRC SD Functional Residual VDs System Dead Space
Capacity Standard
Deviation
FRC/TLC(N2 WO) FRC as % of TLC VDv Valve Dead Space
during N2 Washout
IC Inspiratory Capacity VT Tidal Volume
IRV Inspiratory Reserve Washout Time Washout Time
Volume
LCI Lung Clearance Washout Vol Washout Volume
Index
N2Concentration N2 Concentration %
_InGraph in Graph

13.1.5 Respiratory Mechanics


Parameter Description Parameter Description
Average Exp Average Expiratory Flow R(6) Resistance at 6 Hz
Flow
Average Ins Average Inspiratory R(7) Resistance at 7 Hz
Flow Flow
Ax Reactance Area R(8) Resistance at 8 Hz
Coh Coherence R(9) Resistance at 9 Hz
Fdep (4-24) Frequency dependence R(ResFreq) Resistance at resonant
4-24 Hz frequency
Fdep (4-48) Frequency dependence ResFreq Resonant Frequency
4-48 Hz
FiCO2 Fractional concentration Rocc Exp Rocc Expiratory
of inspired carbon
dioxide

REF C04144-02-91 OMNIA Reference Manual, Edition 15.0 Pag. 289/329


Appendix COSMED Srl

Filter Res. Filter Resistance Rocc Exp CoV Rocc Expiratory


Coefficient of Variation
Flow Thres. Flow Threshold Rocc Exp SD Rocc Expiratory
Standard Deviation
Foccl Occlusion Flow Rocc Insp Rocc Inspiratory
Freq Frequency Rocc Insp CoV Rocc Inspiratory
Coefficient of Variation
Gaw Airway conductance Rocc Insp SD Rocc Inspiratory
Standard Deviation
Gocc Exp Gocc Expiratory sGaw Specific airway
conductance
Gocc Insp Gocc Inspiratory sRaw Specific airway
resistance
MeanR (4-24) Mean Resistance 4-24 sRaw eff Effective Specific airway
Hz resistance
MeanR (4-48) Mean Resistance 4-48 sRaw exp Expiratory Specific
Hz airway resistance
MeanX (4-24) Mean Reactance 4-24 Hz sRaw ins Inspiratory Specific
airway resistance
MeanX (4-48) Mean Reactance 4-48 Hz sRaw Tot Specific airway
resistance Tot
MEP Maximal Expiratory T0 Occl T0 Occl
Pressure
MIP Maximal Inspiratory T1 Occl T1 Occl
Pressure
MIP/MEP MIP/MEP Pressure T2 Occl T2 Occl
Pressure
Mouth Mouth Pressure VDs System Dead Space
Pressure
P0.1 Max Max P0.1 Pressure VT Tidal Volume
P0.1 Pressure P0.1 Pressure X Reactance
Palv Alveolar Pressure X(10) Reactance at 10 Hz
PetCO2 End tidal carbon dioxide X(11) Reactance at 11 Hz
tension
PI Max Max Inspiratory X(12) Reactance at 12 Hz
Pressure
R Resistance X(13) Reactance at 13 Hz

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COSMED Srl Appendix

R(10) Resistance at 10 Hz X(14) Reactance at 14 Hz


R(11) Resistance at 11 Hz X(15) Reactance at 15 Hz
R(12) Resistance at 12 Hz X(16) Reactance at 16 Hz
R(13) Resistance at 13 Hz X(17) Reactance at 17 Hz
R(14) Resistance at 14 Hz X(18) Reactance at 18 Hz
R(15) Resistance at 15 Hz X(19) Reactance at 19 Hz
R(16) Resistance at 16 Hz X(20) Reactance at 20 Hz
R(17) Resistance at 17 Hz X(21) Reactance at 21 Hz
R(18) Resistance at 18 Hz X(22) Reactance at 22 Hz
R(19) Resistance at 19 Hz X(23) Reactance at 23 Hz
R(20) Resistance at 20 Hz X(24) Reactance at 24 Hz
R(21) Resistance at 21 Hz X(25) Reactance at 25 Hz
R(22) Resistance at 22 Hz X(26) Reactance at 26 Hz
R(23) Resistance at 23 Hz X(27) Reactance at 27 Hz
R(24) Resistance at 24 Hz X(28) Reactance at 28 Hz
R(25) Resistance at 25 Hz X(29) Reactance at 29 Hz
R(26) Resistance at 26 Hz X(30) Reactance at 30 Hz
R(27) Resistance at 27 Hz X(31) Reactance at 30 Hz
R(28) Resistance at 28 Hz X(32) Reactance at 30 Hz
R(29) Resistance at 29 Hz X(33) Reactance at 30 Hz
R(30) Resistance at 30 Hz X(34) Reactance at 30 Hz
R(31) Resistance at 31 Hz X(35) Reactance at 30 Hz
R(32) Resistance at 32 Hz X(36) Reactance at 30 Hz
R(33) Resistance at 33 Hz X(37) Reactance at 30 Hz
R(34) Resistance at 34 Hz X(38) Reactance at 38 Hz
R(35) Resistance at 35 Hz X(39) Reactance at 39 Hz
R(36) Resistance at 36 Hz X(4) Reactance at 4 Hz
R(37) Resistance at 37 Hz X(40) Reactance at 40 Hz
R(38) Resistance at 38 Hz X(5) Reactance at 5 Hz
R(39) Resistance at 39 Hz X(6) Reactance at 6 Hz
R(4) Resistance at 4 Hz X(7) Reactance at 7 Hz
R(40) Resistance at 40 Hz X(8) Reactance at 8 Hz

REF C04144-02-91 OMNIA Reference Manual, Edition 15.0 Pag. 291/329


Appendix COSMED Srl

R(5) Resistance at 5 Hz X(9) Reactance at 9 Hz


R(5-19) Resistance at 19 Hz Z(5) Impedance at 5 Hz
subtracted from the
resistance at 5 Hz
R(5-20) Resistance at 20 Hz
subtracted from the
resistance at 5 Hz

13.1.6 6MWT
Parameter Description Parameter Description
∆ IC Delta IC IV Max Maximum Inspiratory
Volume
6MWD Distance walked MVV Maximum Voluntary
during Six Minute Ventilation
Walk Test
6MWW Six Minute Walk Work P Diast Diastolic Blood
Pressure
BR Breathing Reserve P Syst Systolic Blood
Pressure
Dyspnea Ratings of Perceived Rf Respiratory Frequency
Exertion
FEV1 Forced Exp Volume in SpO2 Oxygen saturation as
1s measured by pulse
oximetry
HR Heart Rate Sup. O2 flow Supplemental oxygen
(flow)
IC Inspiratory Capacity Suppl. O2 Supplemental oxygen
IV Inspiratory Volume VE Minute Ventilation

13.1.7 Metabolic
CPET
Parameter Description Parameter Description
% Fat % Fat PaO2 Arterial oxygen
tension
Barom_Altitude Barometric Altitude PAO2 Alveolar oxygen
tension

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COSMED Srl Appendix

Battery Battery Level PAO2 Supp. Alveolar Oxygen


Tension Supp.
Bike Crank Bike crank cadence PeCO2 Mixed carbon dioxide
Cadence (ANT+) partial tension
Bike Power Bike Power (ANT+) PeO2 Mixed oxygen partial
tension
Bike Speed Bike Speed (ANT+) PetCO2 End tidal carbon
dioxide tension
Bike Torque Bike torque PetO2 End tidal oxygen
Eff@Left effectiveness left tension
crank (ANT+)
Bike Torque Bike torque pH pH value
Eff@Right effectiveness right
crank (ANT+)
Bike Bike torque crank Phase Exercise phase
Torque@crank (ANT+)
Bike Wheel Bike wheel cadence Phase Info Phase Information
Cadence (ANT+)
BR Breathing Reserve Phase time Phase time
Cadence Accelerometer based Power Power
cadence
CHO% Carbohydrate % PRO% Protein %
CI e Cardiac Index Qt Qt
Estimated
CI_Fick Cardiac Index R_time Time @ current heart
according Fick beat (from beginning
of storage)
CO e Cardiac Output Real Grade Real Grade
Estimated
CO_Fick Cardiac Output Real Power Real Power
according Fick
CO2exp Volume of Carbon Real Speed Real Speed
Dioxide expired during
current breath
Device Temp. Device Temperature Revolution Revolution
DP Double Product Rf Respiratory Frequency

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Appendix COSMED Srl

dSpO2 SPO2 delta RPM Revolutions Per


Minute
Dyspnea Ratings of Perceived SaO2 Oxygen saturation of
Exertion the hemoglobin of
arterial blood
EEh Energy Expenditure by Satellites Used Satellites
hour
EEkc Energy Expenditure by Satellites SNR Satellites Signal to
day Noise Ratio
EEkg Energy Expenditure by Slope Slope
kg by day
EELV End-expiratory lung SmO2_1 Saturated Hb
volume percentage (sensor 1)
EEm Energy Expenditure by SmO2_2 Saturated Hb
minute percentage (sensor 2)
EEtot Cumulative Energy SmO2_3 Saturated Hb
Expenditure percentage (sensor 3)
EILV End-inspiratory Lung SmO2_4 Saturated Hb
Volume percentage (sensor 4)
FeCO2 Fractional Speed Speed
concentration of
expired carbon dioxide
FeO2 Fractional SpO2 Oxygen saturation as
concentration of measured by pulse
expired oxygen oximetry
FetO2 End tidal fractional Step Length Step Length
concentration of
expired oxygen
FiCO2 Fractional Stride Cadence Step Cadence (ANT+)
concentration of
inspired carbon
dioxide
FiO2 Fractional Stride Count Number of steps
concentration of
inspired oxygen
Fixing GPS Valid Stride Distance Step Distance (ANT+)
GPS Altitude Altitude from GPS Stride Speed Step Speed (ANT+)
GPS Dist. GPS Distance SV Stroke Volume

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COSMED Srl Appendix

GPS Heading GPS Heading SV e Stroke Volume


Estimated
GPS Speed GPS Speed SV_Fick Stroke Volume
according Fick
Grade Grade SvO2 Mixed venous oxygen
saturation
HCO3- Bicarbonate T(<=88%) Time below 88% of
SPO2
Heading Magnetometer based T(dSpO2>4%) Time above 4% of
heading SPO2 delta
HR Heart Rate Test Time Time of test
HRR Heart Rate Reserve THb_1 Total Muscular
Hemoglobin (sensor 1)
HRR_1_minute Heart rate recovery THb_2 Total Muscular
after a minute Hemoglobin (sensor 2)
IC Inspiratory Capacity THb_3 Total Muscular
Hemoglobin (sensor 3)
IRV Inspiratory Reserve THb_4 Total Muscular
Volume Hemoglobin (sensor 4)
IV Inspiratory Volume Torque Torque
La- Lactate User 1 User 1
Lat Latitude User 2 User 2
Leg Pain Ratings of Perceived User 3 User 3
Leg Pain
Load 1 Generic Load 1 V_Batt Battery Voltage
Load 2 Generic Load 2 VCO2 Carbon dioxide
production
Load 3 Generic Load 3 VD/VT Proportion of tidal
volume ventilating
dead space
LogVE Logarithm of Minute VD/VT e Estimated Proportion
Ventilation of tidal volume
ventilating dead space
Long Longitude VDm Mask Dead Space
mark Dist. mark Dist. VDs System Dead Space
mark Speed mark Speed VE Minute Ventilation

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Appendix COSMED Srl

Marker Marker during test VE/VCO2 Ventilatory equivalent


for carbon dioxide
Max HR Maximum value of VE/VCO2 interc. Ventilatory equivalent
Heart Rate during test for carbon dioxide
intercept
METS Metabolic Equivalent VE/VCO2 slope Ventilatory equivalent
for CO2 slope
npRQ Non proteic VE/VO2 Ventilatory equivalent
Respiratory Exchange for oxygen
Ratio
O2 Cost O2 Cost of Walking VFL/VT Regulation of
Ventilatory Capacity
during Exercise
O2exp Volume of Oxygen VO2 Oxygen uptake
expired during current
breath
OUES Oxygen Uptake VO2%Pred VO2%Pred
Efficiency Slope
P Diast Diastolic Blood VO2/HR Oxygen pulse
Pressure
P Syst Systolic Blood VO2/Kg Relative Oxygen
Pressure Uptake (kg)
P(A-a)O2 Alveolar-arterial PO2 VO2/Kg%Pred VO2/Kg%Pred
difference
P(a-et)CO2 Arterial-end tidal VO2/WR Slope VO2/WR Slope
PCO2 difference
Pacing Target Speed VO2@VT1/LT1 Oxygen uptake at
VT1/LT1
PaCO2 Arterial carbon dioxide VT/IC VT/IC
tension
PaCO2_e Estimated arterial
carbon dioxide tension

REE
Parameter Description Parameter Description
% Fat % Fat REE Resting Energy
Expenditure
Bias Flow Bias Flow Rf Respiratory Frequency

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Blower Blower Rf Respiratory Frequency


Body T Body temperature RQ Respiratory Exchange
Ratio
CHO Carbohydrate Sup. O2 flow Supplemental oxygen
(kcal/day) (flow)
CHO% Carbohydrate % Suppl. O2 Supplemental oxygen
EEh Energy Expenditure by Test Time Time of test
hour
EEkc Energy Expenditure by UN Urinary Nitrogen
day
EEkg Energy Expenditure by User 1 User 1
kg by day
EEm Energy Expenditure by User 2 User 2
minute
EEtot Cumulative Energy User 3 User 3
Expenditure
FeCO2 Fractional VCO2 Carbon dioxide
concentration of production
expired carbon dioxide
FeO2 Fractional VDm Mask Dead Space
concentration of
expired oxygen
FiCO2 Fractional VDs System Dead Space
concentration of
inspired carbon
dioxide
FiO2 Fractional VE Minute Ventilation
concentration of
inspired oxygen
Marker Marker during test VO2 Oxygen uptake
npRQ Non proteic VO2%Pred VO2%Pred
Respiratory Exchange
Ratio
PetCO2 End tidal carbon VO2/Kg Relative Oxygen
dioxide tension Uptake (kg)
PH2O Flow Flowmeter Water VO2/Kg%Pred VO2/Kg%Pred
Pressure
PRO PRO (kcal per day) VP Pump Ventilation

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Appendix COSMED Srl

PRO% Protein %

13.1.8 Pulse Oximetry


Parameter Description Parameter Description
6MWD Distance walked Marker Marker during test
during Six Minute
Walk Test
6MWD%Pred Distance walked Min SpO2 Minimum oxygen
during Six Minute saturation during test
Walk Test as a % of
the predicted
6MWD Pred Predicted distance mMRC Medical Research
walked during Six Council modified scale
Minute Walk Test for dyspnea
6MWW Six Minute Walk Work P Diast Diastolic blood
pressure
Avg SpO2 Average oxygen P Syst Systolic blood
saturation pressure
Baseline Baseline duration Phase Phase
Duration
Baseline SpO2 Baseline oxygen PI Perfusion Index
saturation
BODE Index BODE Index Recovery Recovery duration
Duration
Dyspnea Ratings of Perceived SpO2 Oxygen saturation as
Exertion measured by pulse
oximetry
Exercise Exercise duration Sup. O2 flow Supplemental oxygen
Duration (flow)
FEV1 Forced Exp Volume in Suppl. O2 Supplemental oxygen
1s
Final HR Heart Rate at the end T(SpO2≤%) SpO2 cumulative
of Exercise residence time below
the set threshold
(refer to 4.7.8)
Final SpO2 Oxygen saturation at T(ΔSpO2>%) Cumulative residence
the end of Exercise time of SpO2 %
difference from the
baseline SpO2 being

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COSMED Srl Appendix

greater than the set


value (refer to 4.7.8)
HR Heart Rate Test Duration Test duration
HR Max Maximum value of Walk Path Walk path
Heart Rate during test
Lap Lap Walking Walking distance
distance
Laps Completed Number of completed Walking Speed Walking speed
# laps
Leg Pain Ratings of Perceived
Leg Pain

13.1.9 ECG
Parameter Description Parameter Description
DP Double product S V4 Slope of S-T segment
in Lead V4
HR Heart Rate S V5 Slope of S-T segment
in Lead V5
HRR Heart Rate Reserve S V6 Slope of S-T segment
in Lead V6
HRR_1_minute Heart rate recovery ST aVF Level of S-T segment
after a minute in Lead aVF
P Diast Diastolic Blood ST aVL Level of S-T segment
Pressure in Lead aVL
P Syst Systolic Blood Pressure ST aVR Level of S-T segment
in Lead aVR
RR_ECG R-R interval current ST I Level of S-T segment
heart beat in Lead I
S aVF Slope of S-T segment in ST II Level of S-T segment
Lead aVF in Lead II
S aVL Slope of S-T segment in ST III Level of S-T segment
Lead aVL in Lead III
S aVR Slope of S-T segment in ST V1 Level of S-T segment
Lead aVR in Lead V1
SI Slope of S-T segment in ST V2 Level of S-T segment
Lead I in Lead V2

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Appendix COSMED Srl

S II Slope of S-T segment in ST V3 Level of S-T segment


Lead II in Lead V3
S III Slope of S-T segment in ST V4 Level of S-T segment
Lead III in Lead V4
S V1 Slope of S-T segment in ST V5 Level of S-T segment
Lead V1 in Lead V5
S V2 Slope of S-T segment in ST V6 Level of S-T segment
Lead V2 in Lead V6
S V3 Slope of S-T segment in
Lead V3

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13.1.11 Body Composition


Parameter Description Parameter Description
% Fat % Fat Fat Free Mass Fat Free Mass Density
Density
% FFM % Fat Free Mass FFM Fat Free Mass
Airway Airway Pressure FM Fat Mass
Pressure
AMR Activity Metabolic Rate Mean Volume Mean Volume
BMI Body Mass Index Meas Volume Measurement Volume
Body Density Body Density Merit Merit
Body Mass Body Mass Method Method
Body Volume Body Volume Predicted TGV Predicted TGV
Calibration Calibration Mass REE (ADP) e REE ADP (Estimated)
Mass
Cylinder Cylinder Volume Ref Volume Reference Volume
Volume
Entered TGV Entered TGV TEE_e Estimated TEE
Fat Fat Window Max Window Max
Fat Density Fat Density Window Min Window Min

13.1.12 Offline test


Parameter Description Parameter Description
BE Base Excess MDRD Modification of Diet in
Renal Disease
FeNO Fractional Exhaled Nitric Na+ Sodium ion
Oxide
HDL High Density Lipoprotein Total Total Cholesterol
Cholesterol
LVEF Left Ventricular Ejection
Fraction

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Appendix COSMED Srl

13.2 Glossary of Predicted Sets

13.2.1 Spirometry
Predicted Name Reference
GLI Multi-ethnic reference values for spirometry for the 3–95-yr
age range: the global lung function 2012 equations, Philip H.
Quanjer, Sanja Stanojevic, European Respiratory Journal 2012
40: 1324-1343.
ERS93 Standardized Lung Function Testing: Lung Volumes and Forced
ventilatory Flows.Official Statement of the European
Respiratory Society, The European Respiratory Journal Volume
6, Supplement 16, March 1993, 5-40
Zapletal 69 Compilation of reference values for lung function
measurements in children: Ph. H. Quanjer, J. Stocks, G.Polgar,
M. Wise, J. Karlberg, G. Borsboom; ERJ 1989, 2, Supp.4,184s-
261s.
MDB Spirometric reference values from a Mediterranean population:
J, Roca, Navajas, Bull, Eur, Physiopathol, Respir, 1986, 22, 217-
224
Falaschetti Prediction equations for normal and low lung function from the
Health Survey for England, Falaschetti, Eur Respir J. 2004
Mar;23(3):456-63.
Kuster Reference equations for lung function screening of healthy
never-smoking adults aged 18-80 years, Kuster, Eur Respir J.
2008 Apr;31(4):860-8
Forche 27. Verordnung des Bundesministers für Arbeit und Soziales
über die GesundheitsüberwaschungVerordnung des
Bundesministers für Arbeit und Soziales über die
Gesundheitsüberwaschung
Langhammer Forced spirometry reference values for Norwegian adults: the
Bronchial Obstruction in Nord-Trøndelag Study, Langhammer,
Eur Respir J. 2001 Nov; 18(5):770-9.
Solymar Nitrogen single breath test, flow-volume curves and spirometry
in healthy children, 7-18 years of age, Solymar, Eur J Respir Dis.
1980 Oct;61(5):275-86.

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Gulsvik Expiratory and inspiratory forced vital capacity and one-second


forced volume in asymptomatic never-smokers in Norway,
Gulsvik, Clin Physiol. 2001 Nov;21(6):648-60
Kundson 83 Changes in the normal maximal expiratory flow-volume curve
with growth and aging, Knudson, Am Rev Respir Dis. 1983
Jun;127(6):725-34.
NHANES III Spirometric reference values from a sample of the general U.S.
population, Hankinson, Am J Respir Crit Care Med. 1999 Jan;159
(1):179-87
Crapo 81 Reference spirometric values using techniques and equipment
that meet ATS recommendations, Crapo, The American Review
of Respiratory Disease, 01 Jun 1981, 123(6):659-664
Polgar Pulmonary function testing in children: Techniques and
standards, Polgar, J Pediatr. 1979 Jul;95(1):168-70.
Gutierrez Reference values of pulmonary function tests for Canadian
(Canada, Caucasians, Gutierrez, Can Respi J 2004; 11(6): 414-424
Spirometry)
Norma Mex Prediction equations for spirometric parameters in Mexican
adult population, Merida, Archives of Medical Research Volume
35, Issue 5, 10 September 2004, Pages 446-449
Gutierrez Valores extraìdos do Programa Pneumobil/Brasil para a Tese de
Doutoramento do Dr. Carlos Alberto de Castro Pereira
(Boehringer)
Gutierrez (Chile) Determination of spirometric values in a normal Chilean
population over 5 years old, at sea level, Gutierrez, Rev Med
Chile 1996, 124:1295-1306
Pereira 1992 Spirometric nomograms for Chilean normal adults, Gutierrez,
Rev Chil Enf Respir 2010; 26: 9-15
Pereira 2006 Valores de Referência para Espirometria em uma amostra da
população brasileira adulta, Pereira CAC; Jornal de
Pneumologia 1992; 18: 10-22
Pereira 2007 Novos valores de referência para espirometria forçada em
(SBPT 2008) brasileiros adultos de raça branca, C.A de Castro Pereira, J Bras
Pneumol,, 2007;33(4):397-406
Prata 2018 Valores de referencia para espirometria em criancas e
(Brazil) adolescentes, calculados a partir de uma amostra de cidade de

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Appendix COSMED Srl

Sao Paulo,Mallozi MC, C.A. Pereira , Jornal de Pneumologia


1996; 22:105-164 (use this reference for people aged 6-24 yrs)
LAM Novos valores de referência para espirometria forçada em
brasileiros adultos de raça branca, C.A de Castro Pereira, J Bras
Pneumol,, 2007;33(4):397-406 (use this reference for people
aged > 25 yrs)
Mary IP (Spiro) Spirometry reference values for Black adults in Brazil, C, A, de
Castro Pereira, J Bras Pneumol. 2018;44(6):449-455
Thai A survey of ventilatory capacity in Chinese subjects in Hong
Kong, Lam, Annals of Human Biology, 1982, vol, 9, No, 5, 459-
472
Chhabra (India) Updated spirometric reference values for adult Chinese in Hong
Kong and implications on clinical utilization, IP, Chest. 2006
Feb;129(2):384-92 (use this reference for people aged 19-80
yrs)
Udwadia Lung Function Reference Values in Chinese Children and
Adolescents in Hong Kong, Am J Respir Crit Care Med Vol 162.
pp 424–429, 2000 (use this reference for people aged 7-18 yrs)
Choi Jung Keun Reference Spirometric Values for Healthy Lifetime Nonsmokers
in Thailand: Dejsomritrytai W, et al, J Med Assoc Thai 2000; 83:
457-466
ITS Prediction Equations for Spirometry in Adults from Northern
India, Chhabra Indian J Chest Dis Allied Sci 2014;56:221-229
Jones 2020 Reference values for spirometry in Brazilian children. J Bras
(Brazil) Pneumol. 2020; 46(3)

13.2.2 DLCO
Predicted Name Reference
ECCS Standardization of the measurement of transfer factor
(diffusing capacity). Report Working Party Standardization of
Lung Function Tests, European Community for Steel and Coal.
Official Statement of the European Respiratory Society, Cotes,
Eur Respir J Suppl. 1993 Mar;16:41-52.
Paoletti Reference equations for the single-breath diffusing capacity. A
cross-sectional analysis and effect of body size and age,
Paoletti, Am Rev Respir Dis. 1985 Oct;132(4):806-13

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Roca Single-breath carbon monoxide diffusing capacity prediction


equations from a Mediterranean population, Roca, Am Rev
Respir Dis. 1990 Apr;141(4 Pt 1):1026-32
Gulsvik Single breath transfer factor for carbon monoxide in an
asymptomatic population of never smokers, Gulsvik, Thorax.
1992 Mar;47(3):167-73
Crapo & Morris Standardized single breath normal values for carbon monoxide
diffusing capacity, Crapo, Am Rev Respir Dis. 1981
Feb;123(2):185-9
Knudson The single-breath carbon monoxide diffusing capacity.
Reference equations derived from a healthy nonsmoking
population and effects of hematocrit, Knudson, Am Rev Respir
Dis. 1987 Apr;135(4):805-11
Gutierrez Reference values of pulmonary function tests for Canadian
(Canada) Caucasians, Gutierrez, Can Respir J. 2004 Sep;11(6):414-24
Chhabra (India, Prediction equations for diffusing capacity (transfer factor) of
DLCO) lung for North Indians, Chhabra, Lung India. 2016 Sep-
Oct;33(5):479-86
Burrows 1961 Clinical usefulness of the single-breath pulmonucy diffusing
capacity test, Burrows, Am Rev Respir Dis. 1961 Dec;84:789-806
Hwang Development of Prediction Equation of Diffusing Capacity of
Lung for Koreans, Hwang, Tuberc Respir Dis (Seoul). 2018
Jan;81(1):42-48
Mary IP Hong Reference values of diffusing capacity of non-smoking Chinese
Kong (DLCO) in Hong Kong, IP, Respirology. 2007 Jul;12(4):599-606
GLI (DLCO) Official ERS technical standards: Global
Lung Function Initiative reference values
for the carbon monoxide transfer factor
for Caucasians, S.Stanojevic, Eur Respir J 2017; 50: 1700010

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13.2.3 Body plethysmography


Predicted Name Reference
ERS93/ECCS Standardized lung function testing. Official statement of the
European Respiratory Society, Eur Respir J Suppl. 1993
Mar;16:1-100.
Zapletal 69 Compilation of reference values for lung function
(BBox) measurements in children, Quanjer, Eur Respir J Suppl. 1989
Mar;4:184S-261S
Roca/ECCS Prediction equations for plethysmographic lung volumes, Roca,
Respir Med. 1998 Mar;92(3):454-60
Koch 2012 Static lung volumes and airway resistance reference values in
healthy adults, Koch, Respirology. 2013 Jan;18(1):170-8
Garcia-Rio Lung volume reference values for women and men 65 to 85
years of age, Garcia Rio, Am J Respir Crit Care Med. 2009 Dec
1;180(11):1083-91
Asthma UK Reference equations for specific airway resistance in children:
Initiative (BBox) the Asthma UK initiative, Stanojevic, Eur Respir J. 2010
Sep;36(3):622-9
GLI (Lung Function Initiative reference values for static lung volumes in
Volume, BBox) individuals of European ancestry. Hall GL, Filipow N, Ruppel G,
et al. Eur Respir J 2021; 57: 2000289
Gutierrez Reference values of pulmonary function tests for Canadian
(Canada, BBox) Caucasians, Gutierrez, Can Respir J. 2004 Sep;11(6):414-24.
Chhabra (India, Prediction equations for diffusing capacity (transfer factor) of
BBox) lung for North Indians, Chhabra, Lung India. 2016 Sep-
Oct;33(5):479-86
Mary IP Hong Lung function reference values in Chinese children and
Kong (BBOX) adolescents in Hong Kong. II. Prediction equations for
plethysmographic lung volumes, Ip, Am J Respir Crit Care Med.
2000 Aug;162(2 Pt 1):430-5.

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13.2.4 Nitrogen Washout


Predicted Name Reference
ERS93 (N2WO) Standardized lung function testing. Official statement of the
European Respiratory Society, Eur Respir J Suppl. 1993
Mar;16:1-100.
GLI (Lung Function Initiative reference values for static lung volumes in
Volume, N2WO) individuals of European ancestry. Hall GL, Filipow N, Ruppel G,
et al. Eur Respir J 2021; 57: 2000289
Zapletal 69 Compilation of reference values for lung function
(N2WO) measurements in children, Quanjer, Eur Respir J Suppl. 1989
Mar;4:184S-261S
Roca Prediction equations for plethysmographic lung volumes, Roca,
Respir Med. 1998 Mar;92(3):454-60
Gutierrez Reference values of pulmonary function tests for Canadian
(Canada, Caucasians, Gutierrez, Can Respir J. 2004 Sep;11(6):414-24.
N2WO)
Chhabra (India, Prediction equations for diffusing capacity (transfer factor) of
N2WO) lung for North Indians, Chhabra, Lung India. 2016 Sep-
Oct;33(5):479-86
Mary IP Hong Lung function reference values in Chinese children and
Kong (N2WO) adolescents in Hong Kong. II. Prediction equations for
plethysmographic lung volumes, Ip, Am J Respir Crit Care Med.
2000 Aug;162(2 Pt 1):430-5.

13.2.5 Respiratory Mechanics (MIP/MEP)


Predicted Name Reference
Black-Hyatt Maximal respiratory pressures: normal values and relationship to
age and sex, Black, Hyatt, Am Rev Respir Dis. 1969
May;99(5):696-702.
Evans The assessment of maximal respiratory mouth pressures in
adults, Evans, Respir Care. 2009 Oct;54(10):1348-59.
Gutierrez(Canad Reference values of pulmonary function tests for Canadian
a, Resp Mech) Caucasians, Gutierrez, Can Respir J. 2004 Sep;11(6):414-24.
Neder Reference values for lung function tests. II. Maximal respiratory
pressures and voluntary ventilation, Neder, Braz J Med Biol Res.
1999 Jun;32(6):719-27.

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Wilson Predicted normal values for maximal respiratory pressures in


caucasian adults and children, Wilson, Thorax 1984; 39: 535-538

13.2.6 Airways Resistance (Rocc)


Predicted Name Reference
Lombardi Reference values of interrupter respiratory resistance in healthy
preschool white children, Lombardi, Thorax. 2001
Sep;56(9):691-5
Asthma UK Reference ranges for interrupter resistance technique: the
Initiative Asthma UK Initiative, Stanojevic, Eur Respir J. 2010
Jul;36(1):157-63
Merkus Measurements of interrupter resistance: reference values for
children 3-13 yrs of age, Merkus, Eur Respir J. 2002
Oct;20(4):907-11.
McKenzie Airway resistance measured by the interrupter technique:
normative data for 2-10 year olds of three ethnicities,
McKenzie, Arch Dis Child. 2002 Sep;87(3):248-51.
Beydon Pre/postbronchodilator interrupter resistance values in healthy
young children, Beydon, Am J Respir Crit Care Med. 2002 May
15;165(10):1388-94.

13.2.7 Airways resistance (FOT)


Predicted Name Reference
Brown Reference equations for respiratory system resistance and
reactance in adults, Respiratory Physiology & Neurobiology 172
(2010) 162–168
G.Hall, P.Sly Respiratory function in healthy young children using forced
oscillations. Thorax. 2007;62(6):521–6
Kanokporn Respiratory Impedance Reference Values for Forced Oscillation
Technique Predicted by Arm Span and Height in Thai Preschool
Children, PEDIATRIC ALLERGY, IMMUNOLOGY, AND
PULMONOLOGY, 2017
Lombardi, Respiratory impedance and bronchodilator responsiveness in
Calogero healthy children aged 2– 13 years. Pediatr Pulmonol.
2013;48(7):707–15

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Oostveen, Respiratory impedance in healthy subjects: baseline values and


Hantos bronchodilator response, Eur Respir J 2013; 42: 1513–1523
Sajal-Banerjee Regression equations of respiratory impedance of Indian adults
(adults) measured by forced oscillation technique, Lung India 2020
2020;37(1):30-36
Sajal-Banerjee Regression Equations of Respiratory Impedance Measured by
(children) Forced Oscillation Technique for Indian Children, The Indian
Journal of Pediatrics, 2020 Mar;87(3):192-199
Dencker Reference values for respiratory system impedance by using
impulse oscillometry in children aged 2-11 years, Clinical
Physiology and Functional Imaging, 2006, 26(4): 247-50
Nowowiejska Transient reference values for impulse oscillometry for children
aged 3-18 years. Pediatr Pulmonol. 2008; 43(12):1193-7
Klug, Bisgaard Specific airway resistance, interrupter resistance, and
respiratory impedance in healthy children aged 2-7 years.
Pediatr Pulmonol. 1998; 25(5):322-31
Frei Impulse Oscillometry: reference values in children 100 to 150
cm in height and 3 to 10 years of age. Chest. 2005;
128(3):1266–73

13.2.8 6MWT
Predicted Name Reference
Enright & Sherril Reference equations for the six-minute walk in healthy adults,
enright, Am J Respir Crit Care Med. 1998 Nov;158(5 Pt 1):1384-
7.
Troosters Six minute walking distance in healthy elderly subjects,
Troosters, Eur Respir J. 1999 Aug;14(2):270-4
Gibbons Reference values for a multiple repetition 6-minute walk test in
healthy adults older than 20 years, Gibbons, J Cardiopulm
Rehabil. 2001 Mar-Apr;21(2):87-93.
Camarri Six minute walk distance in healthy subjects aged 55-75 years,
Camarri, Respir Med. 2006 Apr;100(4):658-65. Epub 2005 Oct
17.
Geiger Six-minute walk test in children and adolescents, Geiger, J
Pediatr. 2007 Apr;150(4):395-9, 399.e1-2.

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Appendix COSMED Srl

Chetta Reference values for the 6-min walk test in healthy subjects 20-
50 years old, Chetta, Respir Med. 2006 Sep;100(9):1573-8. Epub
2006 Feb 7.

13.2.9 Resting Metabolism


Predicted Name Reference
Harris Benedict A Biometric Study of Human Basal Metabolism, Harris-Benedict,
Proc Natl Acad Sci U S A. 1918 Dec;4(12):370-3
Mifflin A new predictive equation for resting energy expenditure in
healthy individuals, Mifflin, Am J Clin Nutr. 1990 Feb;51(2):241-
7.
Owen A reappraisal of caloric requirements in healthy women, Owen,
Am J Clin Nutr. 1986 Jul;44(1):1-19.
Schofield Predicting basal metabolic rate, new standards and review of
previous work, Schofield, Hum Nutr Clin Nutr. 1985;39 Suppl
1:5-41.
WHO/FAO/UNU Energy and protein requirements. Report of a joint
FAO/WHO/UNU Expert Consultation, World Health Organ Tech
Rep Ser. 1985;724:1-206.
ESPEN ESPEN Guidelines on Parenteral Nutrition: Intensive care;
Clinical Nutrition 28 (2009) 387–400

13.2.10 Exercise Testing (Clinical)


Predicted Name Reference
FRIEND (Clinical) Reference Standards for Cardiorespiratory Fitness Measured
With Cardiopulmonary Exercise Testing Using Cycle
Ergometry: Data From the Fitness Registry and the
Importance of Exercise National Database (FRIEND) Registry,
Myers, Kaminsky, Mayo Clin Proc. 2017 Feb;92(2):228-233
Peak oxygen pulse responses during maximal
cardiopulmonary exercise testing: Reference standards from
FRIEND, Int J Cardiol 2020 Feb 15;301:180-182
The VE/VCO2 Slope During Maximal Treadmill
Cardiopulmonary Exercise Testing: REFERENCE STANDARDS
FROM FRIEND, J Cardiopulm Rehabil Prev 2021 May
1;41(3):194-198

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Wasserman Principles of Exercise Testing and Interpretation, Wasserman K, Hansen


(Clinical) JE, Sue DY, Whipp BJ. 1994, II ed 72-86. Philadelphia: Lea and Febiger.
WHO (Clinical) Essential of Cardiopulmonary Exercise Testing, Jonathan N.Myers,
Human Kinetics 1996
Jones (Clinical) Normal standards for an incremental progressive cycle ergometer test,
Jones, Am Rev Respir Dis. 1985 May;131(5):700-8.
Schneider Age dependency of oxygen uptake and related parameters in exercise
(Clinical) testing: an expert opinion on reference values suitable for adults,
Schneider, Lung. 2013 Oct;191(5):449-58
Harkel (Clinical) Normal values for cardiopulmonary exercise testing in children, Harkel,
Eur J Cardiovasc Prev Rehabil. 2011 Feb;18(1):48-54
French Normal Maximal oxygen uptake in healthy children: factors of variation and
Values (pre available standards, Matecki, Rev Mal Respir. 2001 Oct;18(5):499-506
puberty,
Clinical)
French Normal Maximal oxygen uptake in healthy children: factors of variation and
Values (post available standards, Matecki, Rev Mal Respir. 2001 Oct;18(5):499-506
puberty,
Clinical)
SHIP (Clinical) Reference values for cardiopulmonary exercise testing in healthy
volunteers: the SHIP study, Koch, Eur Respir J. 2009 Feb;33(2):389-97
Bongers Takken Pediatric norms for cardiopulmonary exercise testing in relation to sex
(Clinical) and age (2nd ed.), Bongers, Takken, Hertogenbosch, the Netherlands:
Uitgeverij BOXpress, 2014
Hansen (Clinical) Predicted values for clinical exercise testing, Hansen, Am Rev Respir
Dis. 1984 Feb;129(2 Pt 2):S49-55.
Blackie (Clinical) Prediction of maximal oxygen uptake and power during cycle
ergometry in subjects older than 55 years of age, Blackie, Am Rev
Respir Dis. 1989 Jun;139(6):1424-9
Fairbarn Prediction of heart rate and oxygen uptake during incremental and
(Clinical) maximal exercise in healthy adults, Fairbarn, Chest. 1994
May;105(5):1365-9
Edvardsen Reference values for cardiorespiratory response and fitness on the
(Norway) treadmill in a 20- to 85-year-old population, Edvardsen, Chest. 2013
(Clinical) Jul;144(1):241-248

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Appendix COSMED Srl

FRIEND (Clinical) Reference Standards for Cardiorespiratory


Fitness Measured With Cardiopulmonary Exercise Testing Using Cycle
Ergometry: Data From the Fitness Registry and
the Importance of Exercise National Database (FRIEND) Registry,
Myers, Kaminsky, Mayo Clin Proc. 2017 Feb;92(2):228-233
Low Lands Reference values for maximum oxygen uptake relative to body mass in
Fitness Registry Dutch/Flemish subjects aged 6–65 years: the LowLands Fitness
Registry, European Journal of Applied Physiology, Feb 2021
Lewthwaite Normative Peak Cardiopulmonary Exercise Test Responses in Canadian
(Clinical) Adults Aged ≥40 Years. Chest. 2020 Dec;158(6):2532-2545

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13.2.11 Exercise Testing (Healthy)


Predicted Name Reference
FRIEND Reference Standards for Cardiorespiratory Fitness Measured With
(Healthy) Cardiopulmonary Exercise Testing Using Cycle Ergometry: Data From
the Fitness Registry and the Importance of Exercise National Database
(FRIEND) Registry, Myers, Kaminsky, Mayo Clin Proc. 2017
Feb;92(2):228-233
French Normal Registry
Values (pre
puberty,
Healthy)
French Normal Maximal oxygen uptake in healthy children: factors of variation and
Values (post available standards, Matecki, Rev Mal Respir. 2001 Oct;18(5):499-506
puberty,
Healthy)
SHIP (Healthy) Reference values for cardiopulmonary exercise testing in healthy
volunteers: the SHIP study, Koch, Eur Respir J. 2009 Feb;33(2):389-97
Bongers Takken Pediatric norms for cardiopulmonary exercise testing in relation to sex
(Healthy) and age (2nd ed.), Bongers, Takken, Hertogenbosch, the Netherlands:
Uitgeverij BOXpress, 2014
Edvardsen Reference values for cardiorespiratory response and fitness on the
(Norway) treadmill in a 20- to 85-year-old population, Edvardsen, Chest. 2013
(Healthy) Jul;144(1):241-248
FRIEND Reference Standards for Cardiorespiratory
(Healthy) Fitness Measured With Cardiopulmonary Exercise Testing Using Cycle
Ergometry: Data From the Fitness Registry and
the Importance of Exercise National Database (FRIEND) Registry,
Myers, Kaminsky, Mayo Clin Proc. 2017 Feb;92(2):228-233
PREVENTION Reference values for peak oxygen uptake: cross-
FIRST (Healthy) sectional analysis of cycle ergometry-
based cardiopulmonary exercise tests of 10 090 adult German voluntee
rs from the Prevention First Registry, Rapp, BMJ Open. 2018 Mar 5;8(3)
ACSM (Healthy) ACSM's Guidelines for Exercise Testing and Prescription, 8th Ed
Lewthwaite Normative Peak Cardiopulmonary Exercise Test Responses in Canadian
(Healthy) Adults Aged ≥40 Years. Chest. 2020 Dec;158(6):2532-2545

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Appendix COSMED Srl

13.3 Guidelines for automatic interpretation

13.3.1 Pulmonary function testing interpretation


Software automatic interpretation for pulmonary function testing has been
designed in agreement with the following guidelines:
ATS/ERS, “Standardization of lung function testing, Interpretative strategies
for lung function tests”, European Respiratory Journal, 2005.
J. Vestbo et al., “Global Initiative for Chronic Obstructive Lung Disease
(GOLD): Global strategy for diagnosis, management and prevention of
chronic obstructive pulmonary disease”, American Journal of Respiratory
and Critical Care Medicine, 2013.
N. Beydon et al., “An Official American Thoracic Society/European
Respiratory Society statement: pulmonary function testing in preschool
children”, American Journal of Respiratory and Critical Care Medicine,
2007.
L. Mele et al., “Assessment and validation of bronchodilation using the
interrupter technique in preschool children”, Pediatric Pulmonology, 2010.

13.3.2 CPET interpretation


Software automatic interpretation for CPET tests has been designed as a
combination of the following guidelines:
ATS/ACCP, “ATS/ACCP Statement on Cardiopulmonary Exercise Testing”,
American Journal of Respiratory and Critical Care Medicine, 2003.
EACPR/AHA, “Clinical recommendations for cardiopulmonary exercise
testing data assessment in specific patient populations”, European Heart
Journal, 2012.
G. Balady et al., "Clinician’s Guide to Cardiopulmonary Exercise Testing in
Adults", Circulation, 2010.

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13.4 Integrated Devices

This section describes the integrated devices and how to configure them on OMNIA
software to execute the tests. Always refer to the device user manual for
information on device operation, connections and parts.

13.4.1 Oximeter
Oximeters measure the hemoglobin saturation and retrieve real-time SpO2 and HR
to OMNIA.
Integrated Oximeters
Integrated oximeters can be used during CPET and RMR tests. To integrate the
parameters measured by the oximeter during a CPET test, Metabolic Cart must be
selected from the HR Source dropdown in the CPET start window.

Note: If more than one HR source is connected to the Metabolic Cart, OMNIA
records the HR value in this order of priority: HR monitors, TTL ECG,
oximeter.

Nonin 3150 WristOx2


The Nonin 3150 WristOx2 pulse oximeter can be used for walking/titration tests
(see section 6.10). Data are transferred to OMNIA via Bluetooth®.
Pairing Requirements
Walking tests/Titration module (REF A-670-100-029).
Power Saving mode disabled on PC.
PC with internal Bluetooth® Low Energy module or external
Bluetooth® Low Energy adapter properly installed (e.g. USB BT500
adapter).

Note: If you are using an adapter and the PC already has an integrated
Bluetooth® radio, be sure that the internal PC Bluetooth® radio is
disabled.

Bluetooth® drivers properly installed on PC.


Nonin 3150 WristOx2 turned on (the device sets in pairing mode
for 2 minutes after battery installation).

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Appendix COSMED Srl

Note: Maximum Bluetooth® communication range varies depending on obstacles


or electromagnetic environment.

To pair the Nonin 3150 WristOx2 with the PC:


Select Add Bluetooth device on PC, then press Bluetooth.
Select Nonin3150 to allow the pairing.
Check that “paired” is displayed below the device. If pairing fails, re-insert
the batteries and repeat pairing.

13.4.2 PC ECG
COSMED PC ECGs can be used either as integrated or as standalone devices.
Standalone Configuration
The standalone configuration is described in section 6.10.
Integrated Configuration
The integrated configuration is supported by CPET tests. To execute a CPET test with
the Stress PC ECG software:
Select PC Software ECG from the HR Source dropdown in the CPET start
window. The Stress PC ECG software opens automatically and allows to
configure the ECG settings by pressing on button. The control of
equipment is relegated to OMNIA and the protocol phases, load values and
blood pressure are imported and displayed on PC Software ECG (remote
protocol configuration disables PC ECG software protocol buttons).
Press in OMNIA to start the test.
Run the CPET test as described in section 6.8 and use the Stress PC ECG
software to store events.
Press in OMNIA to stop the test and to store the recorded ECG in
OMNIA in PDF format.
Press in OMNIA to edit the ECG on the Stress PC ECG software and
generate PDF report.
During the editing OMNIA shows a message on the side bar. Press Ok in the
side bar to save the edited ECG in OMNIA.

13.4.3 TTL ECG

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TTL ECGs can be used as HR sources during CPET tests to integrate the HR values
only. Metabolic Cart must be selected from the HR Source dropdown in the CPET
start window to configure a TTL ECG.

Note: If more than one HR source is connected to the Metabolic Cart, OMNIA
records the HR value in this order of priority: HR monitors, TTL ECG,
oximeter.

13.4.4 Mortara®
Mortara® ECG can be used as an integrated device during CPET tests. The
integration requires the auxiliary Mortara® X-Scribe CP software and Mortara®
Stress, GDT Cardiopulmonary and Connectivity licenses. However, refer to Mortara®
for all up-to-date information.
To execute a CPET test with the integrated Mortara® ECG:
Select Mortara® XScribe from the HR Source dropdown in the CPET start
window. X-Scribe is automatically launched in Cardiopulmonary mode (X-
Scribe CP) and works as a slave application to OMNIA. The control of
equipment is relegated to OMNIA and the protocol phases, load values and
blood pressure are imported and displayed on Mortara® X-Scribe CP.
X-Scribe CP enters the Observe phase. Wait for the automatic detection of
the average complex on X-Scribe CP and press in OMNIA to start the
test.
Run the CPET test as described in section 6.8.
Press in OMNIA to stop the test.
X-Scribe CP enters a Monitoring phase. During this phase the interpretation
can be written.
Press Save on X-Scribe CP to export the ECG report (Mortara® PDF must be
selected to export the report as a PDF) and then press Exit to save report in
OMNIA database.

Note: Dual screen configuration is required because the software appearance


cannot be edited and X-Scribe automatically adjusts the screen resolution.

13.4.5 GE® Cardiosoft

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Appendix COSMED Srl

GE® Cardiosoft, starting from version 7.0, can be used to integrate GE® ECGs during
CPET tests. The integration can be implemented in three different modes,
depending on the physical link used to connect the software:
GE® Cardiosoft and OMNIA running on the same PC.
GE® Cardiosoft and OMNIA running different PCs, connected by a crossover
LAN cable or by using a switch or an HUB connected with patch cable.
GE® Cardiosoft and OMNIA running different PCs, connected by RS-232 null
modem cable.

In all modes GE® Cardiosoft works as a Master while OMNIA works as a Slave,
therefore OMNIA toolbars become inoperable during testing and protocol creation
and ergometers control are relegated to GE® Cardiosoft.

Note: Ensure that before the exercise phase at least two phases are created,
which can either be left blank or set to rest and warm-up (multiple warm-up
phases accepted).

Exchanged data (protocol information, HR, P Diast and P Syst) do not differ between
modes but procedures to run a test are different. OMNIA shows the required steps
for each mode when running the CPET-ECG integrated test.

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Note: Always refer to GE® for all up-to-date information.

Mode 1

Note: Two monitors are highly recommended for this modality.

To run a CPET-ECG integrated test:


Ensure that the subject ID field is not empty in OMNIA software.
Select GE Cardiosoft-CASE from the HR Source dropdown in the CPET start
window. GE® Cardiosoft is automatically launched.
Confirm patient data in GE® Cardiosoft. Patient ID should match that in
OMNIA.
Select protocol and start the test in GE® Cardiosoft.
Control test phases, including ergometer loads and BP values, from GE®
Cardiosoft.
Press Stop in GE® Cardiosoft and close GE® Cardiosoft.
Confirm test stop in OMNIA.
Click on the OMNIA ECG tab on CPET Visit Review panel to view the ECG
PDF report and open the ECG edit.
Mode 2
To execute a CPET test:
Ensure that the subject ID field is not empty in OMNIA software.
Select GE Cardiosoft-CASE from the HR Source dropdown in the CPET start
window.
Open GE® Cardiosoft.
Confirm patient data in GE® Cardiosoft. Patient ID should match that in
OMNIA.
Select protocol and start the test in GE® Cardiosoft.
Control test phases, including ergometer loads and BP values, from GE®
Cardiosoft.
Press Stop in GE® Cardiosoft and close GE® Cardiosoft.
Confirm test stop in OMNIA.
Click on the OMNIA ECG tab on CPET Visit Review panel to view the ECG
PDF report and open the ECG edit.

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Appendix COSMED Srl

Mode 3
To execute a CPET test:
Select GE Cardiosoft-CASE from the HR Source dropdown in the CPET start
window.
Open GE® Cardiosoft.
Enter patient data in GE® Cardiosoft.
Select protocol and start the test in GE® Cardiosoft.
Control test phases, including ergometer loads and BP values, from GE®
Cardiosoft.
Press Stop in Cardiosoft and close Cardiosoft.
Stop the CPET test in OMNIA.
Open GE® Cardiosoft to view the ECG PDF report or edit the ECG test.

13.4.6 Cardiolex® EC Sense


Cardiolex® EC Sense, starting from version 4.1.8, can be interfaced with OMNIA
during CPET tests. The integration can be implemented in three different modes, as
for GE® Cardiosoft (refer to section 13.4.5).

13.4.7 Tango®
Suntech® Tango® M2 (REF A-661-200-018) is an automated blood pressure monitor
which measures and displays blood pressure synchronized with the subject's ECG.
Tango® retrieves a subject’s systolic and diastolic blood pressure during a CPET test.
It must be powered on before COSMED equipment and requires the integration
with an ECG. Tango® must be selected from the Blood Pressure dropdown in the
CPET start window to configure a Tango®.

Note: Tango® requires the AUX Devices Integration module (REF A-670-100-023).

13.4.8 N-SenTec® DMS


The N-SenTec® DMS digital transcutaneous blood gas monitor can be used during
CPET tests to retrieve emogas analysis parameters. Imported ABG parameters are
SpO2, PaCO2, PaO2 and HR (refer to section 13.1.7). SenTec® DMS must be selected
from the Emogas Analyzer dropdown in the CPET start window to configure the
blood gas monitor.

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Note: N-SenTec® DMS requires the AUX Devices Integration module (REF A-670-
100-023).

13.4.9 Radiometer® TCM5


The Radiometer® TCM5 digital transcutaneous blood gas monitor can be used
during CPET tests to retrieve emogas analysis parameters. The widest range of
imported ABG parameters comprehends SpO2, PaCO2 (shown as tcPCO2 on
Radiometer), PaO2 (shown as tcPO2 on Radiometer) and HR (refer to section
13.1.7). The availability of parameters depend on the probe used. Radiometer
(MonLink 2.0) must be selected from the Emogas Analyzer dropdown in the CPET
start window to configure the blood gas monitor.

Note: Radiometer must be connected to the subject and stabilised in order to


generate data before data are sent to Omnia. This can take up to 3-4
minutes. Using the probe without subject does not return data to OMNIA.

OMNIA automatically discards values outside of the following physiological ranges:


Parameter Accepted range
PaO2 20-160 mmHg
PaCO2 10-80 mmHg
SpO2 40-100 %

Note: Radiometer® TCM5 requires the AUX Devices Integration module (REF A-
670-100-023).

13.4.10 PhysioFlow
PhysioFlow devices integrate with OMNIA retrieving real-time Cardiac Output,
Stroke Volume, Cardiac Index and HR (refer to section 13.1.7) during CPET tests. In
the CPET start window the PhysioFlow communication port must be selected from
the Physioflow dropdown to configure it.

Note: PhysioFlow devices require the AUX Devices Integration module (REF A-670-
100-023).

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Appendix COSMED Srl

13.5 COSMED DB Converter

COSMED DB converter is a tool included in OMNIA installation package which allows


to convert databases from previous COSMED Software generation, called “Suite”,
and import it in OMNIA.

Note: The database conversion is only available for Suite software versions >10.0.
For previous versions please contact COSMED Support.

Get Suite software ready


Refer to Suite user manual for detailed instructions.
Make sure you are running Suite version >10.0.
Download all tests from portable devices to Suite software.
Organize the archive and backup Suite database.
Close Suite software.
Copy the Suite software installation folder to the same PC where you
intend to use OMNIA.
Get OMNIA software ready
Install OMNIA (see section 2 - Installation).
Get COSMED DB Converter ready
Insert the OMNIA installation CD/USB drive.
Run the executable “setup.exe” file located in the “COSMED DB Converter”
folder.
The files distributed by COSMED are virus-free, any prompt on suspicious
file at this stage can be ignored.
Follow the on-screen instructions to complete the installation.
Convert Suite database into OMNIA
Run COSMED DB Converter (search for COSMED DB Converter in the
Windows® Start menu).
Follow the on-screen prompt to perform the database conversion.
Run OMNIA and check the database has been properly converted (see
section 12.1 for troubleshooting).

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Note: After database conversion, do not use the Suite software on the same PC as
OMNIA. To avoid errors, remove the Suite software installation folder from
the PC where OMNIA is installed.

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Appendix COSMED Srl

13.6 Compatible Ergometers

13.6.1 Standard Configuration


The following table lists bikes and treadmill that can be interfaced with OMNIA in its
standard configuration (i.e. no additional software modules required).
Bikes
Brand/Model Name on OMNIA Cable Note
COSMED Bike COSMED Bike REF C01713-01-12 Several models
Ergoline® 900 Ergoline 900 -- --
Ergoline® 900 BP Ergoline 900 BP -- --
Monark® 839E Monark 839E REF C01456-01-12 --
Monark® LC4 Monark LC4R REF C01456-01-12 --
Monark® LC4R Monark LC4R -- --
Monark® LC6 COSMED Bike REF C01456-01-12 Set Ergoline® protocol
on the bike
Monark® LC7 TT COSMED Bike REF C01456-01-12 Set Ergoline® protocol
on the bike
Monark® Monark MEC3V10 -- --
MEC3V10

Treadmills
Brand/Model Name on OMNIA Cable Note
COSMED COSMED Treadmill / REF C01714-01-12 Several models.
Treadmill HP COSMOS Mph and Kmh
COSMED -- Several models.
Treadmill v4 Mph and Kmh
HP Cosmos® -- Several models.
Mph and Kmh
HP Cosmos®v4 -- Several models.
Mph and Kmh
Trackmaster® Trackmaster REF C01936-01-12 Mph and Kmh

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Trackmaster® Trackmaster_v1.2 -- --
Trackmaster® 425 Trackmaster 425 -- Mph and Kmh
Trackmaster® 428 Trackmaster TM428 REF C01936-01-12 Mph and Kmh

Others
Type Note
Arm Ergometer Ergometer not controlled. Can be selected as an additional
test information
Field Testing Can be selected as an additional test information (e.g. when
using a wearable device)
Bike not interfaced Bike is not controlled however you can set a protocol
Treadmill not interfaced Treadmill is not controlled however you can set a protocol

13.6.2 Optional Configuration


The following table lists bikes and treadmill that can be interfaced with OMNIA
when the OMNIA Misc Ergometers Drivers (REF A-670-100-010) is active.
Bikes
Brand/Model Name on OMNIA Cable Note
BCube BCube -- --
Bike Max Bik Max -- --
Bosh Bosh 601 -- --
CatEye CaEye -- --
ClubLine ClubLine -- --
CT100-ErgocardII CT100-ErgocardII -- --
Cyclus 2 Cyclus2 -- --
Ergoline® 500 Ergoline 500-800 -- --
Ergoline® 800 Ergoline 500-800 -- --
Ergo Fit ErgoFit Bike -- --
Imbramed Imbramed Bike -- --
Lode® Angio cpet LodeBike_2channels REF C02567-01-12 --
single test
LODE® Corival LodeBike_2channels REF C02567-01-12 Set WLP protocol on
cpet the bike

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Appendix COSMED Srl

LODE® New Excalibur / REF C02567-01-12 Set WLP protocol on


Excalibur Sport Excalib.Sport(Dev#1) the bike
LODE® New LodeBike_2channels REF C02567-01-12 Set WLP protocol on
Excalibur Sport w/ the bike
PFM
Technogym®Excite Excite-Bike REF C02964-01-12 --

Treadmills
Brand/Model Name on OMNIA Cable Note
Archimed Archimed -- Mph
C-Safe C-Safe --
Technogym®Excit Excite-Treadmill REF C02964-01-12 Mph
e
Imbramed Imbramed Treadmill- --
ATL / Imbramed
Treadmill Master
Lode® Lode Treadmills REF C02567-01-12 Mph and Kmh
Lode® v2 Lode Treadmills v2 REF C02567-01-12 Mph and Kmh
MarquetteT2000 MarquetteT2000 -- Mph and Kmh
MarquetteT2100 MarquetteT2000 -- Mph and Kmh
Power Jog Power Jog
Ram 770 RAM 770 REF C01936-01-12
Technogym®RunR TechnogymRunRace --
ace
Techmachine Tecmachine 1800 --
Track Emul Track Emul --
Woodway® Woodway REF C01714-01-12 Mph and Kmh
Desmo / Front
Line
Woodway® Pro Woodway Pro REF C01714-01-12 Kmh

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13.7 Other Information

13.7.1 Manufacturer’s Information


You may contact the manufacturer directly at the following address for information:
COSMED Srl
Via dei Piani di Monte Savello, 37
00041 Albano Laziale (RM) - ITALY
Voice:+39 (06) 9315492 Fax:+39 (06) 9314580
Email: support@cosmed.it
Internet: www.cosmed.com
Worldwide COSMED offices are listed in corporate web page:
https://www.cosmed.com/en/contact-us
Support, Feedback and Suggestions
If you have any support enquiries, feedback or suggestions please refer to COSMED
Customer Support, support@cosmed.com
Complaints
If you have any complaints, you may inform us at complain@cosmed.it

13.7.2 Privacy Information


Refer to Privacy disclaimer reported in corporate web site:
https://www.cosmed.com/en/company/privacy

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Appendix COSMED Srl

13.8 References

[1] R. P. e. al., «Interpretative strategies for lung function tests,» European


Respiratory Journal, vol. 26, 2005.
[2] M. R. M. e. al., «Standardisation of spirometry,» European Respiratory Journal,
vol. 26, 2005.
[3] B. L. Graham, «Standardization of Spirometry 2019 Update,» American Journal
of Respiratory and Critical Care Medicine, vol. 200, n. 8, 2019.
[4] B. L. Graham, «2017 ERS/ATS standards for single-breath carbon monoxide
uptake in the lung,» European Respiratory Journal, vol. 49, 2017.
[5] N. M. e. al., «Standardisation of the single-breath determination of the carbo
monoide uptake in the lung,» European Respiratory Journal, vol. 26, 2005.
[6] N. Beydon, «An Official American Thoracic Society/European Respiratory
Society Statement: Pulmonary Function Testing in Preschool Children,»
American Journal of Respiratory and Critical Care Medicine , vol. 175, 2007.
[7] P. D. R. e. al., «Consensus statement for inert gas washout measurement using
multiple- and single-breath tests,» European Respiratory Journal, vol. 41, 2013.
[8] A. T. Society, ATS Pulmonary Function Laboratory Management and Procedure
Manual, 2016.
[9] J. W. e. al., «Standardisation of the measurement of lung volumes,» European
Respiratory Journal, vol. 26, 2005.

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13.9 Notes

REF C04144-02-91 OMNIA Reference Manual, Edition 15.0 Pag. 329/329


COSMED Srl

Via dei Piani di Monte Savello 37


Albano Laziale - Rome 00041,
Italy

+39 (06) 931-5492 Phone


+39 (06) 931-4580 Fax

info@cosmed.com | cosmed.com

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