k5 Um en 15.0 (Usa Wellness)

K5
Wearable Metabolic System
User Manual
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COSMED Srl Get Started
This manual has been written to the best of COSMED knowledge and in accordance
with the state of the art.
However, this does not exclude the possibility of there being 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 to IEC 82079.
All trademarks, registered trademarks and logos mentioned in this manual are the
property of their respective owners.
Read this user manual carefully before using the device.

Keep this user manual in a safe place for future reference.
K5 Wellness User Manual, Edition 15.0 (12/2021)

REF C04595-02-91, English edition
Applicable from:
firmware release 2.0.6
software release 2.1
Copyright © 2021 COSMED

COSMED
www.cosmed.com
REF C04595-02-91 K5 Wellness User Manual, Edition 15.0 Pag. 1/154

Get Started COSMED Srl
Table of Contents
Get Started 7
1.1 Manual Information ................................................................................... 8
1.1.1 User manual’s publishing details and revision history ............................... 8
1.1.2 Manual purpose ......................................................................................... 8
1.1.3 Symbols used in this manual...................................................................... 9
1.1.4 Intended audience ..................................................................................... 9
1.1.5 Related documents .................................................................................. 10
1.2 Important Notices .................................................................................... 11
1.2.1 Indications for use ................................................................................... 11
1.2.2 Warnings .................................................................................................. 11
1.2.3 Precautions .............................................................................................. 11
1.2.4 Security Information ................................................................................ 15
1.2.5 COSMED Product Security Policy Statement ........................................... 16
1.2.6 Cyber Security Requirements and Controls ............................................. 16
1.2.7 Firmware Updates Security...................................................................... 17
1.2.8 Battery (Safety, Storage, Transportation and Recycling) ......................... 17
1.2.9 Oxygen Sensor (Safety, Storage, Transportation and Disposal) .............. 18
1.2.10 Glossary of symbols ............................................................................... 19
1.2.11 Disposing of device parts ....................................................................... 22
1.3 Introduction to Cardiopulmonary Exercise Testing .................................... 23
1.4 Device Overview ...................................................................................... 24
1.4.1 Measurement Modes .............................................................................. 24
1.4.2 Operating Modes ..................................................................................... 26
1.4.3 Main Components ................................................................................... 28
Installation 39
Pag. 2/154 REF C04595-02-91 K5 Wellness User Manual, Edition 15.0

2.1 Preliminary Operations ............................................................................. 40

2.1.1 Unpack the device and check content ..................................................... 40
2.1.2 Electrical safety test according to IEC 62353 ........................................... 40
2.1.3 Charge the Batteries................................................................................. 40
2.1.4 Install the battery ..................................................................................... 42
2.1.5 Power ON and OFF ................................................................................... 42
2.1.6 O2 Sensor Installation .............................................................................. 43
2.2 Gas Cylinder Set-Up .................................................................................. 44
2.3 OMNIA Computer Software....................................................................... 46
2.3.1 PC Requirements ...................................................................................... 46
2.3.2 Software Installation ................................................................................ 47
2.3.3 Software Activation .................................................................................. 47
2.3.4 First Login ................................................................................................. 47
2.3.5 USB Pairing ............................................................................................... 48
2.3.6 Bluetooth® Pairing.................................................................................... 49
2.4 Headphone Configuration ......................................................................... 50
Operate the K5 52
3.1 User Interface ........................................................................................... 53
3.1.1 Home page and Main Functions .............................................................. 53
3.1.2 Physical Keyboard .................................................................................... 55
3.1.3 Digital Keyboard ....................................................................................... 55
3.1.4 Device Info................................................................................................ 55
3.2 Settings ..................................................................................................... 56
3.2.1 International............................................................................................. 56
3.2.2 System ...................................................................................................... 56
3.2.3 ANT+ ......................................................................................................... 57
3.2.4 Bluetooth.................................................................................................. 58
3.2.5 Bluetooth Low Energy .............................................................................. 58

3.3 Utility ....................................................................................................... 60

3.3.1 Database .................................................................................................. 60
3.3.2 Control Panel ........................................................................................... 60
3.3.3 Navigation ................................................................................................ 62
3.3.4 Quality Check (QC) ................................................................................... 62
3.3.5 GPL Licenses ............................................................................................. 62
3.4 Calibration ............................................................................................... 63
3.4.1 Recommended Calibration Warm-Up and Intervals ................................ 63
3.4.2 Calibration Menu ..................................................................................... 64
3.4.3 Flowmeter Calibration ............................................................................. 64
3.4.4 Scrubber Calibration ................................................................................ 66
3.4.5 Reference Gas Calibration ....................................................................... 66
3.4.6 Room Air Calibration ................................................................................ 68
3.4.7 Delay Calibration ...................................................................................... 68
3.4.8 Calibration Factors ................................................................................... 69
Perform test with K5 71
4.1 Contraindications ..................................................................................... 72
4.2 Recommendations During Testing ............................................................ 73
4.2.1 K5 Placement ........................................................................................... 73
4.3 Test Overview .......................................................................................... 75
4.3.1 Operating by AC Power or Battery........................................................... 75
4.3.2 Setting up the protocol ............................................................................ 76
4.3.3 Checklist ................................................................................................... 76
4.3.4 Warm-up Time and Calibrations .............................................................. 77
4.3.5 Selecting or Entering Subject Data........................................................... 77
4.3.6 Subject Preparation ................................................................................. 78
4.3.7 Running the test....................................................................................... 84
4.3.8 Test Results .............................................................................................. 85

4.3.9 Disposable and Reusable Items ................................................................ 85

4.4 Glossary of Parameters ............................................................................. 88
OMNIA software 89
5.1 Introduction .............................................................................................. 90
5.2 Operating OMNIA ..................................................................................... 91
5.2.1 Software navigation ................................................................................. 91
5.2.2 User Accounts .......................................................................................... 94
5.2.3 Database Management ............................................................................ 96
5.2.4 Test Execution .......................................................................................... 99
5.2.5 Test Edit and Report ............................................................................... 101
5.2.6 Download tests to OMNIA ..................................................................... 101
5.2.7 Backup Database .................................................................................... 102
Maintenance 105
6.1 Overview ................................................................................................ 106
6.1.1 Recommended Maintenance Schedule ................................................. 106
6.2 Cleaning and Disinfection ........................................................................ 108
6.2.1 Disposable Items .................................................................................... 108
6.2.2 Reusable Parts ..................................................................................... 108
6.3 Sampling line replacement ...................................................................... 109
6.4 O2 Sensor Replacement .......................................................................... 110
6.5 Battery Recalibration .............................................................................. 112
6.6 Calibration 3L syringe recalibration ......................................................... 113
6.7 K5 Firmware Update ............................................................................... 114
6.7.1 Preparing the SD card............................................................................. 114
6.7.2 Firmware Installation ............................................................................. 114
6.7.3 Firmware Update in Recovery Mode ..................................................... 115
6.8 K5 License Update ................................................................................... 116
6.8.1 Update K5 Licenses ................................................................................ 116

6.9 Device Visual Inspection .......................................................................... 117

6.10 Preventive Maintenance ........................................................................ 118
6.11 Advanced Services ................................................................................. 119
Troubleshooting 121
7.1 Miscellaneous Problems .......................................................................... 122
7.2 Error Messages and Notifications ............................................................ 126
Appendix 129
8.1 EMC Conformity ...................................................................................... 130
8.2 IEC 62353 Safety Test .............................................................................. 133
8.3 Warranty and Service Policy .................................................................... 135
8.4 Other Information ................................................................................... 137
8.4.1 Environmental Condition of Use ............................................................ 137
8.4.2 Manufacturer’s Information .................................................................. 137
8.4.3 Privacy Information................................................................................ 138
8.4.4 Disposing of Electrical Equipment ......................................................... 138
8.5 Parts List ................................................................................................. 139
8.5.1 Standard Configuration .......................................................................... 139
8.5.2 Options and Spare parts ........................................................................ 141
8.5.3 Replacement and Re-orders .................................................................. 145
8.6 Safety and Conformity ............................................................................. 146
8.7 Technical Specifications ........................................................................... 148
8.7.1 Hardware specifications ......................................................................... 148
8.7.2 Embedded software specifications ........................................................ 151
8.8 References .............................................................................................. 153
8.9 Notes ...................................................................................................... 154

Get Started

1.1 Manual Information
1.1.1 User manual’s publishing details and revision history

The present K5 wellness user manual provides information to use the device named
K5 Wellness (REF C09090-02-99).
This User 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 user manual; if in doubt, contact COSMED support.
Nothing in this user manual shall limit or restrict in any way COSMED’s right to
revise or otherwise change or modify the device (including its software and parts)
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 device (including software) described
herein.
Whenever the manual is updated, edition changes.
Edition Changes from previous edition [Edition 14.0 Date
(06/2020)]
15.0 Updated the following sections: Manual December 2021
Information, Precautions, Glossary of Symbol,
OMNIA Software, Maintenance Overview,
Cleaning and Disinfection, O2 Sensor
Replacement, Device Inspection, Preventive
Maintenance, Advanced Services, Bluetooth®
Pairing Issues, IEC 62353 Safety Test, Hardware
Specifications
1.1.2 Manual purpose

The K5 wellness user manual provides information that users need for the safe and
effective use and care of the device according to the indications for use. It is
important that all the people using this device read and understand all the
information contained within.
This user manual is an integral part of the device. It must be kept near by the device
to allow a prompt consultation. This user manual describes the K5 with the most
complete configuration with the highest number of options, modules and parts.

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 result
WARNING:
in death or serious injuries.
1.1.4 Intended audience

This user manual is intended for users who install, use, calibrate and maintain the
device.
Users shall be appropriately trained for the correct use of the device and shall have
the necessary knowledge to install, use, calibrate, maintain or repair the device;
moreover, they shall be informed about all hazards and risks associated with the
device.
Note: A separate user manual is provided for cleaning and disinfection and a
service manual is available upon request for repair.
The different levels of users are based on the amount and type of training received,
assuming they have gained proper competence with the functions and risks
associated with the device.
User Competences Tasks
Operator Scientific knowledge of procedures, Test execution (according to
practices and terminology as required indications for use)
for performing test
Expert For installation, calibration and Installation, Calibration
ordinary maintenance technical skills Ordinary maintenance
are recommended (maintenance procedures
addressed in the user manual, see
section 6 -Maintenance )
Service Technical background and awareness Repair
personnel on hazards and risks associated with Complex maintenance
the performed procedures are (maintenance procedures
required covered in the Service Manual)
Service personnel must be authorized
by COSMED or COSMED affiliates

Note: K5 users are assumed to be competent with the functions and risks
associated with the device.
Note: The operations described in section 2 -Installation shall be performed by

personnel competent in each of the described activities.
1.1.5 Related documents

Depending on configuration, additional instructions may be supplied with the
device.
• OMNIA Reference Manual (REF C04144-02-91)
• Cleaning and Disinfection User Manual (REF C05067-02-91)
The following additional documents are applicable for service personnel only:
• K5 Service Manual (REF C04513-02-81)
For third-party devices always refer to the instructions provided with the device.

1.2 Important Notices
1.2.1 Indications for use

The COSMED K5 Wearable Metabolic Technology is a general wellness product that
logs, tracks and trends exercise activity during physical activity, to encourage or help
maintain a general state of health.
Oxygen uptake, carbon dioxide production, ventilation, respiratory rate, heart rate,
and energy expenditure are recorded by the system for real-time or post-exercise
review. Results can be displayed, stored or printed.
K5 is not intended to be used for medical purposes and is not intended to diagnose,
monitor, treat, cure, or prevent any disease or medical condition.
The K5 system is not suitable for use by children under the age of 6.
The system is not intended for Home Use.
1.2.2 Warnings
This device is NOT SUITABLE for operating in presence of flammable anaesthetic
gases or gases other than O2, CO2, N2 and water vapor.
COSMED is not responsible for incidents which may occur due to improper use of
this device. Examples include, but are not limited to:
• operation of the device by not competent personnel
• use of the device in a way which is not indicated in this manual
• not complying with the precautions and instructions described in this
manual
Due to the required level of technical and subject assessment skills, measurements
using K5 should be performed by users trained and competent to:
• operate and maintain the device
• recognize metabolic measurement values within the physiological range
• evaluate the results in light of the subject’s health status
1.2.3 Precautions
Note the following precautions before operating the device to ensure the safety of
the user and subject:
1. This user manual should always be available as a reference while
performing tests

2. The following standards should be applied to ensure the accuracy of

individual test results:
• Parts (including disposables) must only be used as they are
described in this manual. COSMED does not warrant the use of
any unauthorized accessories by the end user. COSMED may offer
suggestions while using such accessories and the complications
they could cause.
• Repairs or modifications of the device should ONLY be performed
by personnel authorized by COSMED or COSMED affiliates.
• Environmental and electrical conditions in which the device
operates should be in compliance with the specifications of this
manual.
• Device maintenance and inspections should be conducted as
described in this manual.
3. Before powering on the system, all components including power cords and
connectors should be inspected. Damaged electrical parts must be
replaced immediately by authorized personnel
4. Gas cylinders:
• Gas cylinders must be handled by experienced and trained
personnel only
• Large gas cylinders provided by the manufacturer or purchased by
the customer must be secured with cylinder safety chains or
safety stands as required by local law
• After removing the cylinder’s protective cap, the valve should be
inspected for damaged threads, dirt, oil and/or grease. Any dust
or dirt should be removed; however, the cylinder should not be
used if oil, grease, or damaged threads are present. Damaged
cylinders have to be marked clearly
• Keep gas cylinders away from heat and do not store gas cylinders
in the presence of open flames
• Ensure that the pressure regulator is compatible with the
intended gas cylinder (chemically and physically) prior to
installation
• The regulator must be properly connected and working pressure
adjusted according to instructions

• The cylinder and pressure regulator must be closed before

disconnecting the cylinder from the device
• Do not damage or remove cylinders labels
• Do not use any force-increasing tools for opening or closing the
cylinder valves
5. Batteries:
• External battery must be removed from the device when it is not
used for an extended period
• Internal battery – can only be replaced by COSMED Authorized
Personnel
• External battery – End user can replace this battery as described
in System Installation Section
6. Battery charger:
• DO NOT expose the charger or power supply to water or liquids,
this can cause damage as the cases are not sealed
• DO NOT open any components (i.e. the charger or power supply),
the parts inside are not serviceable and will void warranty
• DO NOT cover the exhaust fan or obstruct the airflow, this will
cause the charger to overheat
• ONLY USE the dedicated power supply included with the device
• Place the charger in a cool and dry spot, away from external heat
sources
7. Residue and other contaminants in the breathing circuit pose a safety risk
to the subject during testing procedures. Aspiration of contaminants can be
potentially life-threatening. Each component in contact with the subject’s
breath should be cleaned and disinfected prior to each test
8. The cleaning procedures and inspections are described in Cleaning and
Disinfection User Manual
9. The device should not come near any heat or flame sources, flammable or
inflammable liquids or gases and explosive properties
10. The device shall not be used in an oxygen rich environment
11. MR Not Evaluated: DO NOT use this device in a Magnetic Resonance (MR)
environment
12. This device is not intended for use in the presence of flammable
anesthetics, it is not a AP (Flammable anesthetic proof mixtures with air) or

APG (Flammable anesthetic proof mixtures with oxygen or nitrous oxide)

device (according to the IEC 60601-1 definition).
13. The device should not be used in conjunction with medical devices unless
that device is recommended by the manufacturer.
14. When connecting electrical external devices (computer, printer, etc.) make
sure that:
• They have electromagnetic compatibility (EMC), CE marking or
other Local Certifications and low radiation emission displays.
• They are made compliant with IEC 60601-1 (clause 16) by means
of an isolation transformer.
15. Precautions regarding EMC should be taken prior to device installation and
can be found in the EMC section of this manual.
16. Portable and mobile RF communication devices (including antenna cables
and external antennas) should be either powered off or must not be closer
than 30 cm (12 inches) to any part of the device (including cable) to
eliminate potential electrical interferences and the degradation of the
device’s performance.
17. Mobile phones should be turned off to eliminate potential electrical
interferences
18. Only the cables and parts supplied with the equipment should be used with
the device. The use of any other accessories and/or cables may result in
increased emissions or decreased immunity of the equipment
19. The device should not be placed adjacent to or stacked either on top or
under other equipment. If this is absolutely necessary, the device operation
must be verified to ensure normal operation
20. The operator shall not simultaneously touch the battery charger and the
subject
21. The TTL ECG connector is not optically insulated: an external device (ECG)
can be connected to K5 through the optional cable C04109-01-12. DO NOT
use other cables since they cannot guarantee this insulation and they can
cause serious subject injury
22. Do not place the device in a confined space, always provide adequate
ventilation around the device.
23. Carefully route the subject cabling, and external power cables to reduce
the possibility of subject entanglement or strangulation.

24. Extreme caution should be paid when adjusting parts (i.e. harness, etc.)
because subject fingers can be trapped.
25. Mechanical shocks or drops (e.g. as a result for a free fall or bang on hard
surfaces) may have adverse effects on measurements accuracy and on the
device Ingress Protection (IP) rating which can be altered. Whether the
device is visibly externally damaged or not, DO NOT use the K5 and
immediately return it to COSMED or to an authorized service center for a
technical service, COSMED will determine if this service is covered by
warranty or not
26. If you are considering testing animals please contact COSMED to obtain
further information about the use of the device and parts (masks,
flowmeters, etc…).
Note: The device, program algorithms and data presentation of the measured
data have been developed in accordance with the specifications outlined by
the American Thoracic Society (ATS) and European Respiratory Society
(ERS). Additional international references have also been applied where
applicable. All bibliography references are outlined in the Appendix
1.2.4 Security Information

Protecting Personal Information
Protecting personal health information is a primary component of a security
strategy. Each facility using the device must provide the protective means necessary
to safeguard personal information consistent with country laws and regulations,
and consistent with the facility’s policies for managing this information.
Protection can only be realized if you implement a comprehensive, multi-layered
strategy (including policies, processes, and technologies) to protect information and
systems from external and internal threats.
As per its intended use, the device operates in the subject vicinity and contains
personal and sensitive subject data. To ensure the subjects’ safety and protect their
personal health information you need a security concept that includes:
• Physical security access measures - access to the device must be limited to
authorized users. It is essential that you consider physical security
measures to ensure that unauthorized users cannot gain access.
• Operational security measures - for example, ensuring that subjects data
are deleted after completing the measurement.

• Procedural security measures - for example, assigning only staff with a

specific role the right to use the device.
In addition, any security concept must consider the requirements of local country
laws and regulations.
Always consider data security aspects of the network topology and configuration
when connecting the device to shared networks through OMNIA SW. Your 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 facility for
other 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 data.
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 and 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 with regard to the processing of
personal data and on the free movement of such data, and repealing Directive
95/46/EC (General Data Protection Regulation).
1.2.5 COSMED Product Security Policy Statement

Additional security and privacy information can be required to COSMED when
sending an inquiry to support@ cosmed.com.
1.2.6 Cyber Security Requirements and Controls

• K5 cannot be connected directly to a Network.
• K5 can be operated from a networked PC using the OMNIA SW.
As part of your security concept, you are responsible for establishing controls to
protect your network and any networked devices, including the PC where OMNIA
SW is installed, against such cyber security threats.

Network Cyber Security Measures

Only connect COSMED devices operated from OMNIA SW to networks that are
explicitly intended for that purpose. If you connect the device to a network, it is
therefore 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.
1.2.7 Firmware Updates Security

All firmware for Quark devices are designed and built completely by COSMED. There
are no separate user-updatable firmware components from other manufacturers.
COSMED authorized firmware updates for applicable devices, including any
potential cyber security updates, are communicated via the Engineering Change
Notice Process which is a part of the COSMED Quality System. The availability of
firmware updates is published on COSMED web site, at www.cosmed.com/update.
The installation procedure for firmware updates is described in section 6.7.
1.2.8 Battery (Safety, Storage, Transportation and Recycling)

Due to increasing safety concerns raised by the aviation industry, the IATA
regulations governing the shipping of Lithium Batteries have been tightened and
airlines consequently have enforced these regulations. Please note that the safe
transportation of such contents by air and the full compliance to IATA regulations is
the legal responsibility of the Shipper. IATA has produced a guide to help Shippers
understand and comply with the regulations (http:// www.iata.org/).
1. Do not open or dismantle batteries.
2. Do not expose batteries to heat or fire. Avoid storage in direct sunlight.
3. Do not crush, disassemble, puncture the connector terminals.
4. Do not short-circuit a battery.
5. Do not store batteries haphazardly in a box or drawer where they may
short-circuit each other or be short- circuited by other metal objects.
6. Do not remove a battery from its original packaging until required for use.
7. Do not subject batteries to mechanical shock.

8. In the event of a battery leaking, do not allow the liquid to come in contact
with the skin or eyes. If contact has been made, wash the affected area
with copious amounts of water and seek medical advice.
9. Observe the plus (+) and minus (–) marks on battery and equipment and
ensure correct use.
10. Do not use batteries of different manufacture, capacity, size or type in this
device.
11. Keep batteries out of the reach of children.
12. Keep batteries clean and dry.
13. Secondary batteries need to be charged before use.
14. Only use the battery in the application for which it was intended.
15. Do not store batteries longer than 1 month in discharged state.
16. Do not store batteries longer than 1 year without recharge.
The Li-Ion rechargeable battery installed in the device can be removed as described
later in this manual. Battery must be removed and safely stored when it is not used
for an extended period (more than 6 months). Recommendation for storage: Store
the battery below 20°C, low humidity, no dust and no corrosive gas atmosphere.
Store the battery with a state of charge between 40-60%.
Recycling: Recycle batteries according to national and local regulations. Contact
your local representative for assistance. The batteries must be disposed only in a
discharged state at the collection center. In case of not fully discharged batteries,
provide for a risk against short circuits. Short circuits can be prevented by isolating
the terminals with tape.
1.2.9 Oxygen Sensor (Safety, Storage, Transportation and Disposal)

O2 gas sensors are supplied as sealed units and in normal usage represent no
chemical hazard in the sense of the “Control of Substances Hazardous to Health
(COSHH) Regulations” and the Health and Safety at Work Act 1974. Chemical hazard
can however arise if they are misused or abused when leakage may occur. Leakage
may also occur in the event of a manufacturing fault. In order to avoid potential
problems, the following notes should be observed on storage, usage, handling and
the disposal of unwanted sensors:
• Damage: should any sensor be so severely damaged that leakage of the
contents occurs then the following procedures should be adopted:
• Avoid skin contact with any liquid or internal component through
use of protective gloves.

• Disconnect sensor if it is attached to any equipment.

• Use copious amounts of clean water to wash away any spilt liquid.
This is particularly important in equipment where the sensor
involved contains sulphuric acid or phosphoric acid because of the
corrosive nature of these electrolytes.
• Storage: for maximum shelf life sensors should be stored in the containers
in which they are supplied in clean dry areas between 0°C and 20°C. They
must not be stored in areas containing organic solvents or in flammable
liquid stores.
• Transportation: O2 sensors are classified as “batteries wet non-
spillable”(UN2800). They are transported as per IATA PI 872 and 49CFR
173.159a, and need no special packaging, labels etc. as they are not
restricted as per IATA Special Provision A67.
• Disposal: all sensors contain toxic compounds irrespective of physical
condition. They should be disposed of according to local waste
management requirements and environmental legislation. They should not
be burnt since they may evolve toxic fumes.
1.2.10 Glossary of symbols

Device
Symbol Description Symbol Description
Applied part type BF USB connector
(IEC 60601-1, Table D.1,
Symbol 20)
Class II equipment Read the user manual
(IEC 60417-5172, Table D.1, (IEC 60601-1, Table D.2,
Symbol 9) Symbol 10)
Indicates the manufacture’s Warning
catalogue number so that the (IEC 60601-1, Table D.2,
device can be identified Symbol 2)
(ISO 15223-1, Clause 5.1.6)

Indicates the manufacturer’s The device cannot be

serial number so that a specific disposed as unsorted
device can be identified municipal waste (see
(ISO 15223-1, Clause 5.1.7) “Disposing of electrical
equipment”- Directive
2012/19/EU (WEEE))
HR probe / TTL connector Unlocked
Locked
Packaging
Indicates the manufacture’s Indicates the manufacturer’s
catalogue number so that the serial number so that a specific
device can be identified device can be identified
(ISO 15223-1, Clause 5.1.6) (ISO 15223-1, Clause 5.1.7)
Maximum number of identical Indicates a device that can be
packages which may be stacked broken or damaged if not
on one another (ISO 7000-2403) handled carefully
(ISO 15223-1, Clause 5.3.1)
Indicates the correct upright Hooks are prohibited for
position of a package handling the package
(ISO 7000-0623) (ISO 7000-0622)
Indicates the temperature limits Indicates a device that needs to
to which the device can be be protected from moisture
safely exposed (ISO 15223-1, Clause 5.3.4)
(ISO 15223-1, Clause 5.3.7)
Indicates a device that needs Indicates the range of humidity
protection from light sources to which the device can be
(ISO 15223-1, Clause 5.3.2) safely exposed
(ISO 15223-1, Clause 5.3.8)
Indicates the range of Indicates a device that should
atmospheric pressure to which not be used if the package has
the device can be safely exposed been damaged or opened

Indicates a device that is Indicates the date when the

intended for one use device was manufactured
Indicates the date after which Indicates the need for the user
the device is not to be used to consult the instructions for
(ISO 15223-1, Clause 5.1.4) use
(ISO 15223-1, Clause 5.4.3)
Indicates the Authorized UDI data matrix
representative in the European
Community
(ISO 15223-1, Clause 5.1.2)
Indicates the device Do not open the package using
manufacturer a sharp tool
(ISO 15223-1, Clause 5.1.1)
O2 Sensor
Indicates the manufacture’s Indicates the manufacturer’s
catalogue number so that the serial number so that a
device can be identified specific device can be
(ISO 15223-1, Clause 5.1.6) identified
(ISO 15223-1, Clause 5.1.7)
Harmful Indicates the temperature
(Symbol GHS-07) limits to which the medical
can be safely exposed
(ISO 15223-1, Clause 5.3.7)
Read the user manual Indicates the maximum device
(IEC 60601-1, Table D.2, storage interval, starting from
Symbol 10) the manufacturing date
Indicates the date when the

device was manufactured

CO2 Scrubber
Harmful Warning (IEC 60601-1, Table
(Symbol GHS-07) D.2, Symbol 2)
Battery
Warning (IEC 60601-1, Table Recycling Symbol
D.2, Symbol 2)
Read the user manual For Canada & USA: Please

(IEC 60601-1, Table D.2, call
Symbol 10) 1-800-822-8837 for
information on how to
recycle this battery
Recycling Symbol Taiwan Mark of conformity to
applicable European
Directives
Indicates the manufacture’s UL Recognized for US
catalogue number so that the market
device can be identified (ISO
15223-1, Clause 5.1.6)
China RoHS Compliant Dispose of this product
according to local
regulations
FCC mark
1.2.11 Disposing of device parts

The disposal of any device parts must follow facility policy and local regulations.
Specific information for dedicated items (electrical equipment, O2 sensor, battery)
are addresses in this user manual.

1.3 Introduction to Cardiopulmonary Exercise

Testing
Measurement of oxygen uptake during exercise is important for the assessment of

exercise tolerance limitation, development of training programs and evaluating the
efficacy of rehabilitation programs.
A common method for assessing the effects of endurance training is the monitoring
of various respiratory parameters during submaximal or maximal exercise testing.
A barrier of overcome to achieve this goal is to evaluate a subject outside of the
laboratory, in the field with a reliable and valid portable system to measure Oxygen
Consumption (VO2) and Carbon Dioxide Production (VCO2).
Mobile metabolic testing may also be useful to determine the energy cost of work in
sports and real-world activities.

1.4 Device Overview
K5 is a portable “Metabolic Cart”, designed for the measurement of metabolism

from rest to exercise in the lab or field. K5 complies with the most accredited
international guidelines, published by the corresponding scientific societies.
1.4.1 Measurement Modes

K5 can operate in either Mixing Chamber or Breath By Breath measurement mode.
Whenever IntelliMETTM module is active (optional license) both measurements
modes are available.
The two modes differ for sampling technique and data representation. Each mode
have pros and cons which make it more or less appropriate for specific testing
application.
Feature Breath-by-Breath Mixing Chamber
Testing Clinical CPET, rapid changes of Steady state protocols, work
Applications exercise intensity, VO2/VCO2 efficiency studies (running,
kinetics, Exercise Flow Volume cycling…), extreme environmental
Loops. conditions.
Measuring Integration of time aligned Flow, Proportional sample and
principle O2 and CO2 signals collection of exhaled gas via a
miniaturized mixing chamber
Accuracy* < ±3% (up to RF=60 /min) < ±3%
(VO2, VCO2)
Data each breath each breath
collection
Data each breath 30 sec rolling average, updated
representation every 10 sec
Delay Required Not required
Calibration
*comparison against independent metabolic simulator (A. Huszczuk, B.J. Whipp, K.
Wasserman - A respiratory gas exchange simulator for routine calibration in
metabolic studies. A. Huszczuk, B.J. Whipp, K. Wasserman - Eur Respiration J., 1990,
3, 465-468.)

Breath by Breath
A constant volume pump samples exhaled breath continuously at a specific rate.
The built-in O2 and CO2 sensors (together with the complex pneumatic circuitry)
allow measuring the composition of the exhaled air. The K5 measures instantaneous
changes in O2 and CO2 throughout the respiratory cycle, and use complex
equations to compute the oxygen uptake and carbon dioxide production during
each breath. Through calibration procedures, the K5 allows to know the “delay
time” between measurement of minute ventilation and gas fractions, in order to
align the signals and provide accurate calculation of gas exchange variables.
Mixing Chamber
K5 samples a certain percentage of expired gas into a small mixing chamber,
and average together several breaths to determine FeO2 and FeCO2, which
are then used to calculate VO2 and VCO2. K5 miniaturized dynamic mixing
chamber keeps a constant washing time on a ventilation range going from
rest to maximal effort.
Note: Mixing Chamber mode tests are designed for exercise studies, even with
resting phases, however, washing out the mixing chamber requires time
and steady state may not be achieved for several minutes in a resting state
for an adult (children take significantly longer).

1.4.2 Operating Modes

The K5 is a versatile system designed to allow testing in virtually any environment,
from the field to the lab. Tests can be performed in the following configurations:
• Holter/Field Data Recorder
• Telemetry Data Transmission (PC required)
• Stationary/Laboratory (PC required)
Holter/Field Telemetry Stationary/Laboratory
Data N/A (Standalone) Bluetooth® Bluetooth® USB

communicat
ion
Data K5 K5 and PC* K5 and PC*
Storage
Subject Data K5 PC** PC**
Entry
Test Start K5 PC PC
Test Stop K5 K5 or PC K5 or PC

Marker K5 PC PC
Exercise F/V N/A PC PC
Loops****
Ergometer N/A N/A PC (RS232 port)
Control
Power Internal battery Internal battery Internal battery or
mains***
*If telemetry link is lost during data acquisition, the test stored on the K5 should be
downloaded. Therefore, there will be a duplicate of the test with the second one
being the downloaded test
**OMNIA is available in many languages, including Unicode font types. If the
language of OMNIA is Unicode and a Laboratory or Telemetry test is executed, the
subject name will be stored: PC_TEST_N in the K5
***USB connection does not power the K5 unit nor recharge the internal battery
****Exercise Flow Volume loops are stored on the PC hard disk only and should not
be performed using the masks with inspiratory valves
Holter/Field Data Recorder
Holter/Filed mode allows to administer test in the field without the PC. After testing
is completed, data can be downloaded for further analysis:
• via USB cable or Bluetooth® in OMNIA format (XML)
• via SD card in CSV or TXT format
Note: CSV or TXT export cannot to be imported to OMNIA.
The Holter/Field Data Recorder is an ideal operating mode for testing subjects
difficult to monitor by Telemetry (i.e. climbing, long distances races, etc).
Telemetry Data Transmission
The K5 unit contains a Bluetooth® module allowing data to be transmitted by
telemetry. During testing, data are visualized on the PC in a tabular and graphical
format. During testing data is stored in the memory of the portable unit to prevent
the loss of data, should a transmission error occur. Data transmission range is:
• Standard Bluetooth® – 10m
• Long Range Bluetooth® Module (REF C04270-01-11) – 1000 m

Note: Prior to testing the Bluetooth® option must be enabled on K5 and the device
must be paired with the PC.
Note: During test execution in telemetry mode, touchscreen functionalities are

disabled; physical keyboard is always active (e.g. add markers, start/stop
test).
Stationary/Laboratory
Although K5 has been primarily designed for testing in the field, it can also be used
as a conventional laboratory station as it offers the same features of the best stand-
alone devices. Under this operating mode the K5 is simply connected to the PC
through the USB port and all tasks are performed exactly like in any conventional
laboratory device, including driving ergometers.
1.4.3 Main Components

The K5 consists of the following main parts:
• K5 unit
• Batteries
• Battery charger
• AC/DC Power Supply
• Turbine Flowmeter Assembly
• Face Mask and Head cap
• Heart Rate Monitor
• Harness
• USB Cable
• O2 Sensor
• Air Calibration Kit
Additional external sensors and/or devices may be used in conjunction with the
device (HR, oximeter, etc.).
Some of the parts described below are optional and are not included in the
standard packaging.

K5 Unit
The K5 unit is placed on the subject prior to testing using a backpack-style harness.
In this configuration, the distance between subject’s body and the transmitting
antenna is greater than 25mm.
The K5 unit is powered by a rechargeable battery and contains the Oxygen (O2) and
Carbon Dioxide (CO2) analyzers, sample pump, transmitter, barometric sensors and
electronics. The display on the K5 unit is a touch-screen LCD for optimal viewing in
all lighting conditions which responds with gloves or wet fingers allowing testing in
many environments.
The K5 offers the following functions:
• Subject data input
• Gas and turbine calibration (automatic)
• Test execution
• Data storage
• Test data management
• PC data transfer (via USB or Bluetooth®)
• Data processing
Front View

A RECORD key (starts the data D LCD display

acquisition)
B BACK/CHECK key (returns to the E ON/OFF key (turns the device on or
previous menu) off
C Humidity sensor F HOME/MRK key (returns to the home
menu or enter a marker during the
test)
Note: The antenna is not detachable. Attempting to remove it will damage it and
void the warranty!
Note: Do not place the K5 unit in a knapsack or other bag during use. The
measurements will be affected
Top View
A O2 Sensor Compartment F Antenna

B Flowmeter Port G Air Inlet
C Polar® HRM Receiver / TTL ECG Port (if H Power Supply Port
avail.)
D Sampling line port I Headphone Port
E USB Port J Battery / SD Card Slot

Note: To maintain the water tightness rating (IP54 Rating) check that all covers
are properly secured, and chambers closed
Bottom View
A Sample Pump Outlet B Threaded Tripod Mounting Screw for

harness and ergometer clamp
Note: Do not obstruct the sample pump outlet.
Battery Charger and Batteries

The K5 dual battery charger (w/ AC/DC adapter) (REF C04267-01-10) allows up to 2
battery packs (REF C04273-01-05) to be charged simultaneously. Each battery takes
approximately 2-2.5 hours to charge from 0%-100% and can power the unit for
approximately 4 hours.
A External power connector C Battery Bays

B Calibration Buttons D Status bar

Note: Do not discard the yellow safety cap, it must be used during transport,
based on current regulations.
AC/DC Power Supply

The AC/DC power supply (REF C04118-01-30) is a medical grade power adapter
which allows the device to be operated without batteries installed. If the K5 is
powered by this adapter with a battery inserted, the battery will be charged.
Turbine Flowmeter Assembly

Assembly consists of a bidirectional turbine, an optoelectronic reader and a wind
shield. The reader measures infrared light interruptions caused by the spinning
blade inside the turbine. The wind shield is mounted at the distal end of the
assembly to protect the turbine from wind (outdoors) avoiding errors in over and
underestimated volumes. The assembly may be used to measure a wide flow range
and is not affected by ambient conditions (pressure, humidity, room temperature,
exhaled gas composition).
A Turbine REF C02120-01-05 C Wind Shield REF C02107-02-08

B Optoelectronic Reader REF C04020-
01-04

Face Mask and Head Cap

Masks are available in five sizes (petite, x-small, small, medium, large) and should be
assembled with the corresponding head-cap. The proper size should be used for
each subject ensuring proper fit (refer to section 4.3.6). The head cap should be
connected to the mask before attaching to subject. Connect the top first.
A Head cap (various sizes to match Face B V2 Face Mask (with and without
Mask) inspiratory valves)
Heart Rate Monitor (HRM)

The Heart Rate Monitor (REF A-661-200-096) consists of two parts: adjustable belt
and transmitter. The HRM should be placed as close as possible to the K5 unit to
acquire the best signal.
Harness
The purpose of the K5 harness (REF C04320-01-05) is to hold the K5 unit securely
during Telemetry or Holter/Field testing.

Note: A shirt should be worn beneath the harness to avoid direct skin contact and
irritation
USB Cable
The USB cable (REF C04117-01-12) is used to connect the K5 unit to the PC for
downloading tests or operation in laboratory modes.
Note: The USB cable does not supply power to the K5.
O2 Sensor
The Oxygen sensor (REF C04391-01-11) is pre-installed in the K5 before shipment.
The O2 sensor is a Galvanic Fuel Cell (GFC), which must be replaced from time-to-
time based on usage (O2 sensor may degrade in terms of performances regardless
of its usage).
Air calibration extension line

This part shall be use whenever testing in conditions such as the expired subject’s
air could reach the K5 calibration inlet. See section 4.2.1 for further information.

To connect the air calibration extension line

1. Disconnect the air inlet black cap by gently pulling it out
2. Remove the air filter
3. Insert the air calibration extension line filter into the air
inlet port. Push it down until you hear a click
4. Push the air calibration extension line cap towards the
K5 to ensure a tight fitting
5. Position the line far from the subject
6. Reinstall the old filter when disconnecting the extension
line
Heart Rate Monitor (HRM), POLAR (optional)

This specific Polar® Heart Rate Monitor must be used in conjunction with the K5 HR
polar receiver.
A POLAR HR Belt for T34 (w/o C HR Polar® receiver, K5 REF C04108-01-

Transmitter) REF A-661-200-001 06
B POLAR HR Transmitter T34 REF A-661-
200-002
Note: K5 unit can also be interfaced with Polar® Bluetooth® Low Energy (BLE)
heart rate monitor devices.

Calibration Gas Pressure Regulator (optional)

The pressure regulator is connected to the calibration gas cylinder to deliver the
correct output pressure and deliver it to the sampling line for the K5
Once installed, the regulator remains connected to the gas cylinder. The black valve
can be used to open and close the gas cylinder. During the calibration procedure,
O2 and CO2 concentrations are measured by the K5 and correction factors are
calculated and applied to achieve the best accuracy.
There are two pressure regulator styles, depending on the cylinder connection: CGA
973 and UNI 4410, check that the correct option is selected:
• REF A-870-150-012 Regulator K5, MET Mix (outlet CGA-973)
• REF A-870-600-001 Regulator K5, MET Mix (outlet UNI 4410)
Bluetooth® Long-Range Module (option)

The “Long-Range Bluetooth®” module is an option, REF C04270-01-11, which
extends the wireless range to 1000 meters (from 10 meters). The module includes a
USB Bluetooth® dongle to connect to the computer USB port, an authorization
license and two antennas (short and long to cover entire operational range).
Note: Internal PC Bluetooth® must be disabled (from PC Device Manager) if Long-

Range Bluetooth® module is used.

ANT+™ Sensors (option)

K5 has the ability to communicate with ANT+™ sensors.
Standard configuration of the K5 includes the ANT+™ Heart Rate module. ANT+™
Engine license (REF C04272-01-11, Optional) enables additional ANT+™ modules
including bike speed and cadence sensors, bike power meters, stride-based speed
and distance sensors and muscle oxygen monitors. K5 is certified for eight (8)
ANT+™ profiles (refer to https://www.thisisant.com/directory/K5/); this guarantees
interoperability with sensors which are also ANT+™ certified.
Nonin® 3150 Pulse Oximeter (option)

The Nonin® 3150 Pulse Oximeter (REF A-661-600-018) is a small, wrist-based
Bluetooth® device indicated for the measurement, display, storage and transmission
of functional arterial haemoglobin oxygen saturation (%SpO2) and Heart Rate to the
K5. It is intended for spot-checking, data collection and recording for both adult and
pediatric subjects during stationary and motion activities. It can also be used for
subjects who are poorly perfused.
Refer to the Nonin® instructions enclosed with the pulse oximeter for proper use
and maintenance instructions
After the Pulse Oximeter is paired to the K5 and activated, the following parameters
are transferred in real-time:
SpO2 (%) Oxygen Saturation
HR SpO2 Heart Rate
(bpm)
Values are shown on K5 LCD and OMNIA software.
Note: The Nonin® 3150 Pulse Oximeter (REF A-661-600-018) must be purchased
from COSMED as it comes in a custom configuration.

Installation
Installation COSMED Srl
2.1 Preliminary Operations
2.1.1 Unpack the device and check content

The K5 unit and all its parts are included in a custom carrying case. The carrying case
is packed in a cardboard box with foam padding for protection during shipment.
Carefully unpack the K5 and check the packaging contents against the items listed
on the packing list. If any items are missing or damaged, please contact your
authorized local dealer or COSMED support immediately. It is recommended to
keep the packing materials for shipping and transportation. Recycle packaging
materials according to national and local regulations.
2.1.2 Electrical safety test according to IEC 62353

Before putting the device into service, the IEC 62353 safety test provides a method
to determine if there are any potential health hazards to the subject or users of the
device.
This test shall be executed by competent personnel, who are able to recognize
possible consequences and risks arising from non-conforming equipment. Refer to
section 8.2 of this user manual.
2.1.3 Charge the Batteries

K5 standard packaging includes two rechargeable batteries. The device is shipped
with discharged batteries, therefore it is mandatory to charge it before first use.
Safety Warnings
Refer to section 1.2.
To charge the batteries
1. Connect the AC/DC adapter to the dual battery charger
2. Connect the AC/DC adapter to the power source using the power cable
included in the package; all LEDs on the battery charger status bar will flash
momentarily
3. Insert the discharged batteries into the battery bays ensuring that the 5-
slot connector are fully seated; the charging process will start automatically
and will take approximately 2-2.5 hours (from 0-100% charging status)

COSMED Srl Installation
The charging status is indicated by the LEDs on the battery charger status bar and by
the LED embedded in each battery.
Battery charger status bar
LED Color LED Mode Indication
 flashing Battery charging
 flashing Battery calibration mode
 flashing Battery fuel gauge in need
of recalibration
 solid Battery fully charged
 solid Battery fuel gauge
calibrated
 solid Error
Battery LED
Each square on the battery LED indicates a 0-20% charge.
LED Status Indication
■■■■■ 80-100%
■□□□□ 0-20

2.1.4 Install the battery

1. Turn off the unit (if on) and
unplug it from the power
supply (if connected).
2. Open the battery cap by
extracting the handle and
rotating it counterclockwise
(align the arrow with the
symbol)
3. Remove the yellow protective

cap from the battery you
intend to install.
4. Place the battery in the
dedicated slot as shown.
5. Close the battery cap (align

the arrow with the symbol)
Note: Attempting to power on the system with the battery completely discharged
may cause improper functioning.
2.1.5 Power ON and OFF

The K5 unit can operate either when powered by external AC power or by the
internal battery, which is recharged whenever the device is connected to the power.
To operate the K5 via external AC power, connect the AC/DC power adapter
between the mains and the connector on the top of the K5 unit.
To power ON the device
Press and hold ON/OFF button for a few seconds to power on the device.

To power OFF the device

Press and hold the ON/OFF button for a few seconds to power off the device.
Note: Removing AC power does not power off the device. The device remains
powered by the internal battery (if inserted) .
2.1.6 O2 Sensor Installation

The Oxygen sensor is pre-installed in the K5 before shipment. The O2 sensor is a
Galvanic Fuel Cell (GFC), which may degrade in terms of performances regardless of
sensor usage. Expected lifespan of the O2 sensor is 12 months from its installation.
Should a new O2 sensor installation be necessary, refer to the section 6.4.

2.2 Gas Cylinder Set-Up
K5 requires periodical calibration of both Oxygen and Carbon Dioxide sensors using
a reference gas. COSMED provides a 3.7L pressurized Gas Cylinder with a known
and certified gas mixture (16% O2, 5% CO2 and N2 balance). To set-up the gas
cylinder please refer to the instructions below.
Note: The Calibration gas mixture must be specified in Calibration / Cal. Factors /
Gas Reference
A Gas Cylinder Valve B Pressure Regulator ON/OFF Valve

C Pressure Regulator Outlet
WARNING: Always secure the Gas cylinder by using the optional ”Cylinder
stand for ED cylinders w/ thumbscrews” (REF A-860-900-003), or
in another appropriate manner in accordance with local
regulations.

To Install the Pressure Regulator on the Gas Cylinder

1. Close the Pressure Regulator ON/OFF valve (perpendicular to pressure
regulator outlet).
2. Connect the Pressure Regulator to the Gas Cylinder.
3. Appropriately tighten the “T”screw, by hand.
Note: A new white washer should be placed between the Cylinder and the
Pressure Regulator whenever the Gas Cylinder is replaced.
WARNING: The Pressure Regulator should be tightly connected to avoid leaks

(clockwise rotation)

2.3 OMNIA Computer Software
K5 is provided with an optional PC software (OMNIA). K5 can communicate with

OMNIA via Bluetooth® or via USB. Using K5 in conjunction with OMNIA users can:
• Perform tests (remote control)
• Download subject data and tests.
• Manage subject data.
• Review and edit test results.
• Integrate data with HIS.
Note: Calibration procedures cannot be performed via OMNIA software.
This section contains the essential information to install OMNIA software and set it
up to be used in conjunction with K5.
For essential information on how to operate the software with K5, see section 5 -
OMNIA software; for any further details refer to OMNIA Reference Manual.
2.3.1 PC Requirements
Component Minimum Requirements
OS compatibility Windows® 7 SP1 (32-bit, 64-bit), Windows® 8.x (32-bit, 64-bit),
Windows® 10 (32-bit, 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).
Server)

Note: For OMNIA Network additional requirements apply. Please refer to OMNIA
Network Reference Manual.
2.3.2 Software Installation

Note: The following installation instructions are applicable to OMNIA Standalone
only. For OMNIA Network installation, please refer to OMNIA Network
Reference Manual.
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.
2.3.3 Software Activation

OMNIA must be authorized the very first time by connecting the device to PC via
cable. As soon as OMNIA has successfully been installed:
1. Power on the device and connect it to the PC via the available wired
connection. The necessary drivers for communication will be installed
automatically by Windows®.
2. Run OMNIA and login (see section 2.3.4)
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.
2.3.4 First Login

For the first login, you must enter the following credentials:
• Username: admin

• Password: admin
• Domain: Omnia (this field may not be enabled based on your PC
configuration).
Once logged in, you are 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 OMNIA Reference Manual.
Note: Carefully store the password in a safe place. Refer to OMNIA Reference
Manual to reset the password.
At this stage you are logged in as OMNIA Administrator and you can create and
configure users and user roles (for further details see section 5.2.2).
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.
2.3.5 USB Pairing

To pair the Quark with OMNIA
1. Connect the Quark to the PC via USB.
2. Open OMNIA software.
3. Click on Utility.
4. Click on Device Manager.
5. Select K5 from the list of available devices by checking the Enabled box and
set the communication port (if K5 is not in the list click on Scan Devices
first).
6. Click on Show to start the pairing process. The device Serial Number is
shown to confirm successful pairing.
7. Check that the correct device has been paired by verifying the Serial
Number, then click on Save to complete the pairing.

2.3.6 Bluetooth® Pairing

Bluetooth® pairing procedure can be executed only after OMNIA is authorized (see
section 2.3.3). The use of Bluetooth® communication allows measured data to be
transmitted via a Bluetooth® radio from K5 unit to a PC.
K5 features point-to-point communication, allowing one master (PC) to be paired to
one slave (K5). Once connected, K5 cannot be paired with any other Bluetooth®-
enabled device, which reduces the risk of interference and preserves data integrity.
If K5 is being used with wireless communication, use the device within its
designated range. Moving outside this range may cause data loss.
For further details refer to OMNIA Reference Manual.
Requirements
• OMNIA software properly installed on PC.
• Power Saving mode disabled on PC.
• PC with internal Bluetooth® or external Bluetooth® adapter properly
installed, or COSMED Long Range Bluetooth® adapter (REF C04262-01-10)
installed (if available).
• Bluetooth® drivers properly installed on PC.
• K5 turned on and radio communication enabled (see section 3.2.4).
Note: If you are using the Long-Range Bluetooth® adapter and the PC already has
an integrated Bluetooth® radio, be sure that the internal PC Bluetooth®
radio is disabled.
To Pair K5 with OMNIA

1. Open OMNIA software
2. Click on Utility.
3. Click on Device Manager.
4. Select K5 from the list of available devices.
5. Click on Discover in the Bluetooth® column.
6. Select the device to be paired.
7. Click on Pair and wait for operation to complete.
OMNIA automatically stores information on Bluetooth® pairing configuration. It is
not necessary to repeat the paring procedure every time the device is connected to
PC (unless OMNIA authorization has expired, see section 2.3.3).

2.4 Headphone Configuration
One-way communication (from user to subject) during testing is possible using the
headphone port located on top of K5 device. This communication uses Bluetooth®.
To enable K5 device, headphone and microphone follow the below procedure.
Note: Telemetry range is significantly reduced when this function is enabled due
to the high bandwidth for voice data
Screenshots used throughout this section refer to Windows® 8.1 Pro. Slight
differences may affect other Windows® operating systems.
Requirements
K5 paired to Windows® PC (either through OMNIA or Windows® Bluetooth®
Manager)
To configure K5
1. Open Windows® Control Panel on PC and locate your K5 device (check S/N)
in the Device and Printer/Unspecified Devices menu.
2. Right-click on K5 and select Properties.
3. Enable all Bluetooth® Services under the Services tab. Note: It may take a
few seconds for the list to populate.
4. Click Apply, then OK.
To configure headphone
1. Open Sound/Playback from Windows® Control Panel
2. Set “Headset K5 S/N XXXXXXXXXX” as default devices

To configure microphone
1. Open Sound/Recording from Windows® Control Panel
2. Set “Jack Mic” or “Internal mic“ as default devices
3. Right click on the default device, select Properties, and open the Listen tab.
4. Check Listen to this Device and select Headset (K5-########) Hands-Free
from the dropdown
5. Click Apply, then OK.
Note: When headphone is inserted into the K5 you should hear a beep. If there is
no sounds, headphone may be damaged (regardless of paring process).

Operate the K5
COSMED Srl Operate the K5
3.1 User Interface
K5 can be operated using the LCD resistive touch screen. The display allows the user
to interact with the touch screen while wearing gloves. Do not operate the touch
screen area with sharp objects.
Note: The screenshots shown in this manual may not exactly match what is
displayed on your own device
Note: When the screen light is reduced, touching the buttons or the LCD screen
restores the full screen brightness
3.1.1 Home page and Main Functions
Field Description
Test Execute a new test (choose an the existing subject in the archive using
the “Search Subject”function or create a “New Subject”)
Calibration Perform calibrations or review calibration factors
Settings Configure preferences related to International/ System/ Bluetooth/
Bluetooth LE/ ANT+™
Utility System tools including database functions, control panel, navigation,
Quality Check and GPL Licenses

Operate the K5 COSMED Srl
Icons / Buttons
Icons/Buttons Indication
ANT+™ wireless is active
GPS is active
Bluetooth® is active
Bluetooth® Low Energy is active
System sound is active
Remaining battery charge
Device is powered by power supply
Scroll up
Scroll down
Confirm the operation
Abort the operation
Exit from current screen
Show device information
Function enabled (press to disable)
Function disabled (press to enable)
Press to change the content of a field

3.1.2 Physical Keyboard

Four (4) buttons surround the display:
Buttons Description
Begin test recording (light blinks when data is not recorded, remains on during
data storage)
Return to previous menu
Turn device on/off
Return to Home menu / Enter a marker during a test
3.1.3 Digital Keyboard

To enter text, numbers and dates, use the contextual virtual keyboard.
3.1.4 Device Info

Press the info button ( ) to access general information about Archive, System,
Hardware, Firmware, Module Licence.

3.2 Settings
The Settings menu contains the following sections:

• International
• System
• ANT+
• Bluetooth
• Bluetooth Low Energy (BLE)
3.2.1 International
Field Description
Sync with GPS Syncronize with GPS time
Time Zone Set local time zone
Date Set the current date
Time Set the current time
Date Format Set preferred date format
3.2.2 System
Field Description
Screen Timeout Set time before screen sleeps
Sound Enable/Disable audible system feedback
Bluetooth Enable/Disable Bluetooth® radio
BLE Enable/Disable Bluetooth® Low Energy radio
ANT+ Enable/Disable ANT+™
GPS Enable/Disable GPS
Touch Delay Set response time of the touch screen
Delete BLE Bonds Remove the Bluetooth® Low Energy device bonding (use
this function when BLE device pairing function returns a
failure)
Admin Access the administrator menu

3.2.3 ANT+
Field Description
ANT+ Enable/Disable ANT+™
Paired HeartRate Monitor Pair K5 with specific HR monitor
(0 = Auto)
Wheel Circumference Set the Wheel Circumference for Bike Speed Profile
(mm)
HR Enable/Disable HR Profile (available for all devices). If more
than one ANT+™ heart rate monitor is being used in the
area, K5 can be paired with specific HR monitor using the
Paired HeartRate Monitor (see above)
BikeSpd Enable/Disable Bike Speed Profile (Bike Speed and Wheel
Cadence parameters). Requires specification of the rear
wheel circumference (see above)
BikeCad Enable/Disable Bike Cadence Profile (Crank Cadence and
Wheel Cadence parameters)
BikeS&C Enable/Disable Bike Speed and Cadence Profile (Bike Speed,
Crank Cadence, and Wheel Cadence parameters). Requires
specification of the rear wheel circumference (see above)
BikePWR Enable/Disable Bike Power Profile (Bike Power, Torque,
Bike_Torque_Eff_Right, Bike_Torque_Eff_Left, Crank
Cadence, Wheel Cadence, and Speed parameters). It may
require the specification of the rear wheel circumference
(see above)
StrS&Dist Enable/Disable Stride based Speed and Distance Profile
(Step Cadence, Speed, Distance, Stride Length parameters)
MO2 Enable/Disable Muscle Oxygen Profile (SmO2, THb
parameters). When enabled, tap the Paired MO2 sensor
number (no) in list item to run a search that allows you to
assign the desired sensor to the virtual channel number (no)
K5 is compatible with 5 ANT+™ profiles. HR profile is available for all K5 units; other
profiles require ANT+™ module (REF C04272-01-11) and the installation of any
ANT+™ compatible sensors.

Note: If ANT+™ sensors are used, be sure they are active before starting the test
(most ANT+™ sensors activate data transmission only when moved). Pairing
with ANT+™ sensors occurs at the very beginning of the test only!
The number of transmitted parameters for a given ANT+™ sensor, may change
according to sensor manufacturer.
3.2.4 Bluetooth
Field Description
Bluetooth Enable/Disable Bluetooth® radio (it also contains information
about device Bluetooth® address and status)
SPO2 Enable/Disable SPO2 pulse oximeter connection option (it
can be enabled only when Bluetooth is enabled)
Paired SPO2 Pair with specific SPO2 pulse oximeter devices. When pairing
the Nonin® 3150 Pulse Oximeter, Bluetooth® address and ID
displayed on the screen must correspond to the ones on the
back of the Pulse Oximeter
3.2.5 Bluetooth Low Energy

Field Description
BLE Enable/Disable Bluetooth® Low Energy radio
SPO2 (3150) BLE Enable/Disable SPO2 (3150) BLE pulse oximeter connection
option (it can be enabled only when BLE is enabled)
Paired SPO2 Device Pair with specific SPO2 BLE pulse oximeters devices. When
pairing the Nonin® 3150BLE, before proceeding turn on and
wear the oximeter; address and ID displayed on the screen
must correspond to the ones on the back of the Pulse
Oximeter, if you get the message “Device pairing failure“,
disconnect and reconnect 3150BLE’s battery, then repeat the
procedure. If the problem persists, in Settings/System tap on
“Delete BLE bonds” and repeat the procedure
HR BLE Enable/Disable Heart Rate BLE connection option
Paired HR Device Pair with specific Heart Rate devices
HT BLE Enable/Disable Health Temperature BLE sensor connection
option
Paired HT Device Pair with specific Health Temperature BLE sensors

Note: Pairing information stored in K5 is maintained after the system is turned off
or after firmware upgrade.
Note: When more than one HR source is available (TTL, HR monitor), K5 records
the HR value in this order of priority: TTL, Heart Rate, MonitorSpO2.

3.3 Utility
The Utility menu contains the following sections:

• Database
• Control Panel
• Navigation
• Quality Check
• GPL Licenses
3.3.1 Database
Field Description
Search Search for a test on the device, querying by: subject, date,
test type.
When a test is selected, it can be exported as *.txt or *.csv
format to SD card (if installed).
Erase DB Erase the entire database (All data will be lost and cannot
be recovered! Download all tests to PC before proceeding).
DB Status Determine % usage of the database, retrieving the following
information: registered subjects, archived tests and archive
size.
3.3.2 Control Panel

Control Panel is an advanced diagnostic tool for Expert users who have an
understanding of the device measurement technology. It checks device functionality
at a component level (valves, pumps, etc.) including measured signals. When
accessing the Control Panel the operating modality (BxB or Mix) shall be selected.

Field Description
Pump Activate/Deactivate the sampling pump
Sample Sample the gas from the sampling line (activated) or from the air inlet
(deactivated)
Mix Let the sampled gas passing through the mixing chamber if activated
FC Enable/disable the feedback control of pump flow rate (breath by
breath mode only)
Pwm Enable/disable the Pulsed Wave Modulation function in Dynamic mixing
chamber mode
>> / << Navigate to the next/previous screen of header buttons
mV Display data in mV rather than original unit of measurement
Graph Display data in graphic format
Z_CO2 Adjust the CO2 zero
G_CO2 Adjust the CO2 gain
POT Adjust the O2 Trimmer
Realtime P An (mmHg), PB (mmHg), Flow (mL/s), O2(%), CO2(%), Volume (mL), T
Signals Amb (°C), RH Amb (%),HR TTL (bpm), HR ANT+™ (bpm), HR BLE (bpm), F
Sampl (ml/min), Barom Alt (m), T Dev (°C), SPO2 (%), HR SPO2 (%), Aux
batt (mV), Battery (%), HT BLE (°C), IN/EX, T Sampl (°C), RH Sampl (%)

3.3.3 Navigation
Field Description
On/Off Enable/Disable GPS
GPS Data Show visible satellites and corresponding SNR (Signal to Noise Ratio)
Compass Show the compass on the screen
Sync Time Synchronize the device time with GPS time
Realtime Data Sats, SNR, Time (UTC), Lat (N), Long, Alt (m), Heading, MM/DD/YYYY,
Speed (kmh), Baud Rate (baud), Fix Rate (Hz)
3.3.4 Quality Check (QC)

Field Description
System Check Perform a quick evaluation of K5. System failures and warnings are
displayed respectively in red and orange. Tap the QR code icon and use
a QR code reader to export QC information in text file
Battery Status Displays remaining charge and estimated running time.
System will display “Cannot perform tests. Connect AC/DC adapter” if
the remaining charge is not sufficient to perform a test
3.3.5 GPL Licenses

Allow the user to access the information about the General Public License (GPL)
used on the system.
See section 8.7.2 for further details.

3.4 Calibration
3.4.1 Recommended Calibration Warm-Up and Intervals

To ensure accurate measurements, refer to the following calibration warm-up and
intervals recommendations.
Calibration procedures must be performed directly on the K5, the calibration
features of OMNIA do not apply. Calibration information is archived on the device
and not in OMINA calibration archive.
Calibrating or testing with a system which has not been adequately warmed up
could cause inaccurate results.
Specific warm up time are recommended for each test modes (see section 4.3.4).
Note: In cold environment or in case of sudden temperature changes (e.g. after

transportation), additional warm-up time may be necessary.
Note: To ensure optimal warm-up time, K5 sampling pump is always active

(sampling pump goes into a 2 min standby when any command on screen is
selected).
Calibration Warm-up time from Recommended Note

power on at 20°C Interval
(min)
Flowmeter 0 Daily or whenever Recommended after
the turbine is cleaning and
replaced disinfection
Scrubber 20 Before each test ONLY if the test is
performed indoor
Reference Gas 30 Daily ONLY if Mixing
(Mix)* Chamber tests are
performed
Reference Gas 60 Daily ONLY if BxB tests are
(BxB and performed
Delay)*

*Reference gas calibrations are test mode specific. If test mode is changed,
calibration must be performed for that testing mode
Auxiliary Calibrations
The following calibrations are to be used in case no calibration gas is available or for
technical purposes:
• Delay Calibration (required warm-up 60min)
• Room Air – BxB (required warm-up 20min)
• Room Air - Mix (required warm-up 20min)
3.4.2 Calibration Menu

Calibration functions are accessible by tapping on the Calibration tile from the Home
page. Refer to the diagram below to access the required calibration function.
Calibration
Flowmeter Scrubber Reference Gas Room Air Delay Cal. Factors
Flowmeter
BxB and Delay BxB
BxB Cal. Factors
Mix Mix Mix Cal. Factors
Gas References
Set Defaults
3.4.3 Flowmeter Calibration

Flowmeter calibration consists in a comparison between a known volume
(calibration syringe) against the measured one, and in the calculation of
corresponding correction factors (expiratory and inspiratory gain).
A 3-liter calibration syringe is recommended. If a different syringe volume is used,
its value must be entered in Cal. Factors menu.

Each turbine flowmeter requires a specific calibration.
Note: Flowmeter Wind Shield must be used during calibration if used during
testing
A Calibration syringe REF C00600-01- F Turbine 2000 REF C02120-01-05

11
B Wrinkled tube REF A-108-300-012 G Opto-reader 2000 REF C04020-01-
04
C Conic adapter REF C00063-01-20 H Closing ring nut, black REF C02155-
02-08
D Antiviral/antibacterial filter REF A- I Wind Shield REF C02107-02-08
182-300-004/005
E Optoelectronic reader adapter,
black REF C02106-02-08
To calibrate the Flowmeter

1. Connect the parts as shown above
2. Select Flowmeter in the Calibration menu
3. Start the calibration procedure following the on-screen instructions: pull
handle to fully extend syringe piston and then completely push in to cover
full range in consistent manner. Repeat strokes until finished (eight
strokes)
4. Press  to Exit and Save calibration

3.4.4 Scrubber Calibration

This calibration requires that K5 is sampling room air through the external CO2
scrubber cartridge. It is intended to:
• Zeroing of the CO2 analyzer
• Measuring the environmental air composition (FiCO2 and FiO2) and store it
in K5 memory
The calibration is stored until the next power cycle of the K5.
To perform scrubber calibration
Note: This calibration is not necessary when tests are performed outdoors
1. Ensure the system has been warmed up

according to recommendations reported in
this user manual.
2. Connect the sampling line into the CO2
scrubber cartridge as shown
3. Select Calibration/Scrubber and start the
calibration procedure following the on-
screen instructions.
Note: When not in use, store the scrubber in the sealed container; exposure to air
will deplete it.
3.4.5 Reference Gas Calibration

This calibration is a two-points gas calibration: sampling room air and a known
calibration gas supplied by a certified gas cylinder. A 16%O2, 5%CO2 bal. N2 mixture
is recommended. Actual mixture certified values must be specified in Cal. Factors
menu. For further details refer to section 2 -Installation.
Reference gas calibration is intended to:
• Determine correction factors for each gas analyzer (O2 and CO2).
• Adjust the dynamic range for O2 (BxB and Delay only) to compensate for
sensor aging
• Calculate the delay time (BxB and Delay only) affecting both gas analyzers
O2 and CO2

BxB reference gas calibration takes more time than Mix reference gas calibration as
BxB analysis requires time alignment of flow, O2 and CO2 sensors.
The delay is dependent on the following:
• Sample pump flow rate
• Sampling line internal volume
• Gas density (humidity, ambient pressure, etc.)
• Pneumatic circuit resistance
To calibrate Gas Analyzer (BxB and Delay / Mix)
1. Ensure the system has been warmed up according to recommendations
reported in this user manual.
2. Connect sampling line to the Inlet port of K5.
3. Select Calibration/Reference Gas/BxB and Delay or Mix
4. Start the calibration procedure following the on-screen instructions
(connect/disconnect sampling line to the gas regulator outlet when
message is displayed).
K5 standard pre-set gas regulator Adjustable regulator + external calibration
unit (REF C01800-01-05)
Note: Gas Cylinder Valve must be fully open during reference gas calibration.
ON/OFF valve must be opened immediately before sampling line connection
and must be closed soon after sampling line is disconnected. If a message
“Tank gas not detected!” is shown, please check if the cylinder is open and
it is not empty

Note: K5 is shipped with a pre-set regulator; if an adjustable regulator is used, the

output pressure must be set to 3-4 bar to prevent damage to the device.
3.4.6 Room Air Calibration

This calibration procedure can be optionally performed when calibration gas is not
available or for technical purposes. It calculates and updates only a subset of
calibration factors.
Note: During Room Air Calibration, be sure to move the sample line away from
any expired gas, otherwise calibration results could be affected
To calibrate Gas Analyzers with room air (BxB / Mix Mode)

reported in this user manual
2. Press Calibration/Room Air/BXB or Mix
3. Start the calibration procedure following the on-screen instructions.
3.4.7 Delay Calibration

Required for BxB testing only when calibration gas is not available.
To calibrate delay
reported in this user manual.
2. Connect the flowmeter assembly as described in the test overview section
of this manual
3. Press Calibration/Delay
4. Start breathing in the turbine at a constant rate, synchronizing breathing
cycle with the acoustic signal. Each beep corresponds to both an inspiration
and an expiration, so that a complete breath covers two beeps. Press ü to
Exit and Save calibration
Note: To avoid cross contamination issues, consider using and

antiviral/antibacterial filter when performing delay calibration or have the
testing subject to personally perform the calibration.

3.4.8 Calibration Factors

This menu allows for review and modification of calibration results and to configure
reference values (syringe volume and reference gas composition).
To restore the factory settings
• Tap Calibration/Cal. Factors/Set Defaults and confirm
The acceptable ranges and default values are summarized in the following tables.
Flowmeter
Cal. Factor Acceptable Default Note
range
Turbine GainIN 900 - 1100 1000 Flowmeter software span IN
Turbine GainEX 900 - 1100 1000 Flowmeter software span EX
Syringe (mL) 3000 Syringe volume
Vt Threshold (mL) 50
Flowmeter temp 34 Temperature at the flowmeter
(°C)
BxB Cal. factors (BxB Mode)

Range
O2 Trimmer 200 - 800 512 O2 hardware span (at sea level)
O2 Gain 800 - 1200 1000 O2 software span
O2 Base Line (mV) ±300 0 O2 software zero
O2 Delay (ms) 150 - 2000 780 Transport+ O2 analyzer response time
O2 Speed 600 - 2000 1250 Amplification of O2 sensor response
O2 Rise Time (ms) 60 - 220 120 Time for the O2 sensor to respond to a
10 to 90% step like increase in O2
concentration, like during inhalation (Tr)
O2 Fall Time (ms) 60 - 220 120 Time for the O2 sensor to respond to a
90 to 10% step like reduction O2
concentration, like during exhalation (Tf)
CO2 Trimmer 200 - 1000 512 CO2 hardware span
CO2 Gain 800 - 1200 1000 CO2 software span (at sea level)

CO2 Base Line 3600 - 3800 CO2 software zero

(mV) 4000
CO2 Delay (ms) 150 - 2000 740 Transport+ CO2 analyzer response time
CO2 Speed 600 - 6000 Amplification of CO2 sensor response
12000
CO2 Rise Time (ms) 30 - 180 80 Time for the CO2 sensor to respond to a
10 to 90% step like increase in CO2
concentration, like during exhalation (Tr)
CO2 Fall Time (ms) 30 - 180 80 Time for the CO2 sensor to respond to a
90 to 10% step like reduction in CO2
concentration, like during inhalation (Tf)
PCal BxB (mmHg) 350 - 800 700 Analyzer pressure during BxB calibration
Mix Cal. factors (Mix Mode)

O2 Trimmer 200 - 800 512 O2 hardware span (at sea level)
O2 Gain 800 - 1200 1000 O2 software span
O2 Base Line (mV) ±300 0 O2 software zero
CO2 Trimmer 200 - 1000 512 CO2 hardware span
CO2 Gain 800 -1200 1000 CO2 software span (at sea level)
CO2 Base Line 3600 - 3800 CO2 software zero
( )Mix (mmHg)
PCal 400 - 800 Analyzer pressure during Mix calibration
700
Gas reference
Range
Cylinder O2 (%) 5-21 16 Reference gas O2 concentration
Cylinder CO2 (%) 0.07-10 5 Reference gas CO2 concentration
Ambient O2 (%) 20.82- 20.93 O2 concentration in room air
20.93
Ambient CO2 (%) 0.04 - 0.15 0.04 CO2 concentration in room air

Perform test with K5
Perform test with K5 COSMED Srl
4.1 Contraindications
Absolute and relative contraindications to exercise testing balance the risk of the
test with the potential benefit of the information derived from the test. Assessment
of this balance requires knowledge of the purpose of the test for the individual
subject and what symptom or sign end points will be for the individual test.
Refer to the below list as well as your facility policy and local regulations.
• Radtke T, Crook S, Kaltsakas G, et al. ERS statement on standardisation of
cardiopulmonary exercise testing in chronic lung diseases. Eur Respir Rev
2019; 28: 180101
• American Thoracic Society/American College of Chest Physicians.
Statement on cardiopulmonary exercise testing. Am J Respir Crit Care Med
2003; 167: 211–277.
• Fletcher GF, Ades PA, Kligfield P, et al. Exercise Standards for Testing and
Training: A Scientific Statement From the American Heart Association.
Circulation 2013; 128: 873–934.
• Gibbons RJ, Balady GJ, Bricker JT, et al. ACC/AHA 2002 guideline update for
exercise testing: summary article: a report of the American College of
Cardiology/American Heart Association Task Force on Practice Guidelines
(Committee to Update the 1997 Exercise Testing Guidelines). Circulation.
2002;106(14):1883-1892.
For further information refer to section 8.8.

COSMED Srl Perform test with K5
4.2 Recommendations During Testing
Note: Cellular phones should be turned off to eliminate potential electrical

interference
You can achieve the maximal reliability and accuracy of measurements following the
rules described below:
• Have the device regularly maintained according to instructions
• Use only sampling line in good status during testing
• Have the device properly calibrated and warmed up according to
recommendations
• Have residual battery capacity adequate to complete a test
• Position the K5 correctly to avoid reading of possibly contaminated air
• Position and secure the mask to ensure that there are no leaks
For correct collection of auxiliary parameters ensure the following checks are
performed:
• GPS enabled and receiving data from available satellites (if required and
outdoors)
• ANT+™ profiles are enabled and sensors are active before beginning the
test (most ANT+™ sensors activate only when moved; pairing with ANT+™
sensors only occurs at the beginning of the test)
Note: GPS distance during exercise is only calculated when downloaded and
viewed in Omnia
4.2.1 K5 Placement
During all tests, the K5 periodically recalibrates to room air to maintain the stability
of the sensors. During automatic air calibrations, it is necessary that only fresh air
surrounds the K5, not exhaled air from the subject.
To this aim, the K5 has an air inlet on the top of the device; The K5 shall NOT be
positioned anyhow allowing contaminated air (e.g. subject’s expired breaths) to be
sampled from the air inlet.
Using K5 harness avoids the risk of sampling subject’s expired breaths from the air
inlet.

When the K5 is mounted to the handlebars of a stationary cycle ergometer, the

device will be in line with the subjects exhaled breaths. In this scenario, the air
calibration extension line (REF C04971-01-10) provided with the K5 unit can be
connected to the air inlet on the top of the unit to avoid contaminated air to be
sampled.
A fan may also be used when testing in laboratory setting to keep air clean around
the device.

4.3 Test Overview
Testing with K5 can be performed in three different configurations (see section

1.4.2). The information included in this section refer to Holter/Field mode unless
otherwise specified.
The following process shows an overview of the step-by-step procedure to conduct
a test.
# Step Description
1 Protocol set up Define testing protocol.
Check communication between K5 and any optional items
(e.g. ANT+™/BLE sensors).
2 Required Items Collect the necessary items.
3 Warm-up and Follow the recommended warm-up time.
Calibrations Perform calibrations when needed.
4 Subject data entry Select existing subject in the archive or insert a new one.
5 Test set-up Set-up device and parts according to the testing protocol.
Prepare subject.
6 Start the Test Select the Measurement Mode.
Wait for automatic calibration. Check the parameters and
when ready tap Start Recording.
7 Real time execution Supervise the test execution.
8 End of test Tap Stop Recording to store the test.
Disconnect K5 from the subject.
9 Edit Results and Save Review and edit test results and subject’s info (if
Changes necessary).
10 Export Results Export data in the available formats
11 Dispose and Cleaning Disposal of non reusable items.
Clean and disinfect reusable items according to the
instructions in this manual.
4.3.1 Operating by AC Power or Battery

K5 can be powered by the rechargeable battery or plugged into the wall outlet.
Prior to starting a measurement using battery power, make sure that the residual

capacity displayed on screen is enough to complete a test (at least 20%, depending
also on the battery’s age and test duration).
To Power on the Device
1. Press and hold the power button (ON/OFF) for a few seconds to power on
the device.
4.3.2 Setting up the protocol

Define testing protocol. If you intend to use ANT+™ or BLE sensors, make sure the
relevant ANT profile or BLE service is enabled on K5 unit before testing. If you use
any third-party items, refer to manufacturer’s instructions for proper usage.
4.3.3 Checklist
Item Description Note
K5 Wellness unit
REF C09090-02-99
Harness Wear it over a t-shirt

REF C04320-01-05
Turbine
REF C02120-01-05
Wind Shield
REF C02107-02-08
Opto-electronic Reader
REF C04020-01-04 K5

Permapure Sampling Line Consumable, must be

REF C04254-01-08 replaced every 100 studies
or 6 months
Mask with inspiratory valves For tests without Exercise
REF C04324-0X-10 Flow Volume Loops
Mask without inspiratory vales For tests with Exercise Flow

REF C0361X-01-10 Volume Loops
Head cap Head cap size should match

REF A-800-900-02X mask
HR Module w/ elastic strap

REF A-661-200-096
ANT + Sensors Requires ANT+™ Engine
REF C04272-01-11
4.3.4 Warm-up Time and Calibrations

The sensors (O2, CO2, pressure, etc.) are sensitive to temperature changes. K5 has
been designed to compensate for sensor thermal drift using technological solutions
including periodic auto-calibration (transparent to the user).
Recommended warm-up time are:
• BxB test mode: 60 min
• Mix test mode: 30 min
For calibration intervals refer to section 3.4.1.
4.3.5 Selecting or Entering Subject Data

Before starting a test, the K5 requires a subject to be selected (new or existing).
Note: Some subject details (Last/First Name, Date of Birth (DOB), Gender, Height,
Weight and Ethnicity) are mandatory. Missing or incorrect values can be
edited.
To Enter New Subject

1. Tap Test and then New Subject

2. Enter Last/First Name, DOB, Gender, Weight, Height and Ethnicity. This
information is also required to calculate predicted values for main CPET
parameters
3. Confirm subject data
To Select Existing Subject
1. Tap Test and then Search Subject
2. Select the subject from the list
3. Edit subject information, if necessary, and confirm
4.3.6 Subject Preparation

Wearing the Heart Rate Monitor (HRM)
K5 is compatible with any ANT+™ and BLE HR monitors.
1. Adjust the chest strap to fit tightly and
comfortably around the subject’s thorax
2. The electrodes should be moistened with
water or a conductive gel to enhance
electrical conductivity
3. If you are using a POLAR® HRM, connect
the POLAR® HR receiver to the “ ” port
on top of the K5
4. If more ANT+™ HRMs are nearby, pairing
of an individual HRM with each K5 is
recommended. Refer to section 3.2.3 for
more information.
Securing the Harness

K5 harness is designed to be worn like a hiking style backpack. Below are pictures
demonstrating how to properly wear the K5 harness.

Note: Wear a shirt under harness to avoid direct skin contact and irritation
1. Clip the abdomen belt

2. Clip the chest belt as shown to
the right
3. Adjust harness back plate
based on the subject size
4. Tighten the harness to the
subject’s body checking each
belt for optimal comfort and
security
Selecting the Mask

Selecting the appropriate mask size is crucial for accurate data and subject comfort.
A mask which is too large can cause leaks and a mask which is too small may make
the subject feel claustrophobic. The seal inside the mask should fit from the top of
the subject nose (between the eyes) to just below the bottom lip with the base of
the mask going underneath the chin.
General Recommendations:
• Average adult males – Small mask
• Average adult females – Extra Small mask
• Between sizes -> Smaller size

Measurement Mask Size Distance (in) Distance (mm)

(Mouth Closed)
Petite (P) 4.00” 102
Extra Small (XS) 4.40” 112
Small (S) 4.90” 125
Medium (M) 5.40” 137
Large (L) 5.90” 150
Align top of gauge with bridge of nose and measure to bottom of chin. Head cap sizes
match mask sizes
Assemble the mask and the flowmeter

1. Make sure the mask adapter is properly connected to the mask as shown in
the picture below to avoid leaks
2. Plug the turbine in the mask adapter by pushing and rotating it clock-wise
until you feel a stop
3. Insert the optoelectronic reader over the turbine and press it until in line
with the mask adapter
4. Plug the wind shield by pushing and rotating it clock-wise until you feel a
stop
5. Plug the sampling tube in the port located on the wind shield
Note: It is recommended to lubricate periodically the O-rings with medical grade

biocompatible Vaseline.

A Head cap D Optoelectronic reader

B Mask E Wind shield
C Turbine F Sampling line
Note: If Exercise Flow Volume Loops shall be performed during the exercise test, it
is mandatory to use masks without valves.
Securing the Mask

Place the mask as illustrated in the pictures below. After securing the mask, adjust
head cap to form a tight seal and perform a leak test, as described in “Mask Leak
Test”.

Mask Leak Test

After the mask is secured to the subject, the best practice is to perform a leak test
according to the following steps:
1. Disconnect wind shield
2. Ask the subject to perform a deep inhalation
3. Place palm of hand (user or subject) over turbine
4. Ask the subject to perform a deep expiration and check that the mask
remains in place and no air movement is felt around the eyes
Only for mask without inspiratory valve:
5. Place palm of hand (user or subject) over turbine
6. Ask the subject to perform a forced inspiration and check that the mask
compress and no air movement is felt around the eyes
If necessary, tighten headcap to secure or double check mask size and repeat the
test
Securing the K5 to the Harness
1. Place the K5 unit
onto the cradle
2. Secure the unit
using the screw at
the bottom of the
cradle
3. Place the harness
elastic band
around the top of
the K5
4. Check that the unit
is firmly secured

5. Route the
optoelectronic
cable and sampling
line through the
harness as
indicated in the
picture above
6. Plug the turbine
cable in the Flow
port of K5 unit
7. Connect the
sampling line to
the Inlet port of
the K5 unit
Testing with mouthpiece (optional)

When running a sub-maximal tests (ventilation rates <100 L/min), it is possible to
use a rubber mouthpiece, anti-bacterial filter and nose clip instead of a mask.
Assemble the mouthpiece, filter and reader as illustrated in the picture below.
Ensure that no leaks are present between the subject and the mouthpiece.
Testing with antiviral/bacterial filter (optional)

To increase cross contamination prevention, it is possible to connect an
antiviral/bacterial filter to the mask by means of a specific adapter (REF C05085-01-
20).

4.3.7 Running the test

To start the test
1. Tap New Subject or Search Subject and enter or confirm/edit subject data.
2. Select the most appropriate mode according to testing protocol (see
section 1.4.1).
3. Verify values are within physiological range by looking at the parameters
on the screen while data are not recorded ( key is blinking).
Press to start recordin. Screen turns blank and the blue light on
remains on.
4. Review main parameters on LCD during testing and add markers pressing
the key if necessary.
To stop the test
Press the icon to stop the test.
Note: If the light on the REC key button is blinking, data is not being recorded
Note: If data recording is not activated by the user, the K5 will start recording
after 2 min from the first breath

4.3.8 Test Results

Tests can be processed in different ways, outlined below.
Operating mode Data Editing Export mode/format
Visualization
Holter/Field LCD screen After test via USB cable or Bluetooth® in
export OMNIA format (XML)
via SD card in CSV or TXT
format
Telemetry and OMNIA PC Define Via OMNIA in CSV format
Stationary/Laboratory SW VO2max, Via SD card in CSV or TXT
select format
thresholds,
Via USB or Bluetooth® in
advanced
OMNIA format (XML)
editing,
edit/complete
additional
data, PDF
report
4.3.9 Disposable and Reusable Items

The following table summarizes the disposable items and the ones requiring
cleaning procedures for each device operation:
Operation Disposable Reusable (cleaning required)
Testing K5 Wellness
(device surfaces)
REF C09090-02-99
Antibacterial filter Turbine

REF A-182-300-004 REF C02120-01-05
(Round)
or
REF A-182-300-005
(Oval)

Nose Clips Mask without

REF A-662-100-001 inspiratory vales
REF C0361x-01-10
Mouthpiece Mask with

REF C00568-01-98 inspiratory valves
REF C04324-0x-10
Mouthpiece with Head cap
Saliva Trap REF A-800-900-02x
REF A-800-500-001
Optoelectronic
Reader
REF C04020-01-04
Opto-reader 2000,
closing ring
REF C02155-02-08
Wind Shield
REF C02107-02-08
Mask/filter Adapter
REF C05085-01-20
Sampling Line (tip)

REF C04254-01-08
Harness
REF C04320-01-05

Heart Rate
Monitor*
REF A-661-200-096
Polar® Heart rate
(optional)*
REF A-661-200-002
Calibration Syringe Adapter
REF C02106-02-08
3-Liter Syringe
REF C00600-01-11
Corrugated Tube
REF A-108-300-012
Syringe adapter
REF C00063-01-20
*Third party device

4.4 Glossary of Parameters
The following parameters are measured/calculated by K5 and available on device

screen. More parameters are available when using OMNIA software.
Symbol UM Parameter
VO2 mL/min Oxygen Consumption
VCO2 mL/min Carbon Dioxide Production
R Respiratory Exchange Ratio
Vt L(btps) Tidal Volume
Rf 1/min Respiratory Frequency
VE L/min Minute Ventilation
IV L Inspiratory Volume
HR bpm Heart Rate
FeO2 % Expired fraction of Oxygen
FeCO2 % Expired fraction of Carbon Dioxide
FetO2 % End tidal fraction of Oxygen
FetCO2 % End tidal fraction of Carbon Dioxide
O2exp mL Amount of expired Oxygen
CO2exp mL Amount of expired Carbon Dioxide
FiO2 % Inspired fraction of Oxygen
FiCO2 % Inspired fraction of Carbon Dioxide
PB mmHg Barometric Pressure
Pan mmHg Analyzers Pressure
Te s Expiration time (BXB Mode only)
Ti s Inspiration time (BXB Mode only)
Device T °C Device Temperature
Battery % Device Battery
GPS Km/h GPS Speed
Speed
SpO2 % Oxygen Saturation
# Number of breaths

OMNIA software
OMNIA software COSMED Srl
5.1 Introduction
OMNIA is a software platform developed by COSMED designed for data

management, interpretation and reporting of all tests performed with the entire
COSMED product range, from spirometry to lung function equipment and from
metabolic to body composition assessment. OMNIA provides an innovative and
user-friendly interface which allows users to navigate and access the main features
and perform tests easily in a multi-language environment.
OMNIA is available both in Standalone and Network versions. The network version
is fully featured with client / server architecture where a single license can be
shared on local area network (LAN) or wide area network (WAN) environment.
K5 can communicate with OMNIA via Bluetooth® or via USB. Key points for using K5
with OMNIA are:
• Storage of data and results in a secure database (network server or
standalone computer).
• Remote test execution (including Metabolic Protocols creation).
• Advanced data analysis and data export.
• Customizable reports.
• Integration with Hospital Information Systems (HL7® or GDT).

COSMED Srl OMNIA software
5.2 Operating OMNIA
This section contains the essential information to operate OMNIA software with K5.
Note: For further details on OMNIA functionalities refer to the OMNIA Reference
Manual.
5.2.1 Software navigation

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.
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.

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
Minimize
Resize
Close
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:
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
manual.

Some tile may lead to other tiles in accordance with the hierarchical structure of the
software.
The central area of the Home panel is populated as follows:
Database
Testing
Calibration
HOME
Quality Control
Utility
Resource Center
Bottom bar
The bottom bar is populated with:
Go to Home panel
OMNIA version
Open Settings panel
Open the Support request form (internet connection required)
Open OMNIA reference manual

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.
5.2.2 User Accounts

User Accounts utilities can be accessed by clicking on the Utility tile from OMNIA
Home panel.
Users Management
The Users Management panel shows the list of all users that can access the
software and allows to create, delete and manage users’ information .
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.
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 (inactive users cannot log in until re-enabled).
• 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.
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. Standard roles are Administrator, Technical support, PFT Technician, ADP
Technician and Physician.
Roles Management panel 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.
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: By default Administrator is assigned with all rights except servicing rights.
Note: By default Technical Support is not allowed to access or modify the

database, except for the DEMO subject, and is only assigned with servicing
rights (e.g. perform calibrations, access the event log, etc.).
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.
3. Pres Ok to save changes or Cancel to abort.
5.2.3 Database Management

Database can be accessed by clicking on the Database tile from OMNIA Home panel.
The Database panel structure is based on the following hierarchy:
1. Subjects

2. Visits
3. Tests
and is divided in three main areas:
A Side bar B Subject card C Visit card
Side bar
The side bar includes action buttons which may relate to or impact on subjects,
visits or tests.
The main buttons populating the side bar are:
Buttons Description
Create new subject
Download tests from COSMED portable devices (see section

5.2.6)

Subject card
The subject card is populated with the list of existing subjects, displaying
demographic and identifiable information.
The main buttons populating the side bar are:
Buttons Description
Create new visit for the selected subject
Create new test for the selected subject
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.
When a visit is selected the corresponding line is highlighted and the following main
action buttons appear at the end of the line:
Buttons Description
Open the selected visit
The visit can also be opened by double-clicking on the
corresponding line
Print the selected visit.
Select tests and options to Print/Export in PDF format
Export the selected visit in proprietary xml format
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
When a test is selected, the corresponding line is highlighted and the following main
action buttons appear at the end of the line:

Buttons Description
Open the selected test.
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
5.2.4 Test Execution

Tests can be remotely executed from OMNIA, once a valid USB or Bluetooth® link
with K5 has been established (see section 2.3.5 or 2.3.6)
Test data are simultaneously stored in the PC database and device memory.
Note: K5 touch screen control is disabled when a test is controlled by OMNIA.
To Enter New Subject

1. From OMNIA software, click Database and create a new subject clicking on
(see section 5.2.3).
2. Enter subject data (the following fields are mandatory, as many of them
are required to calculate predicted values: First Name, Last Name, Date of
Birth (DOB), Gender, Ethnicity, Height and Weight) and click Save.
3. Complete visit data and click Save.
To Select Existing Subject
1. From OMNIA software, click Database.
2. Select the subject from the list.
3. Create a new visit clicking on or select an existing Visit corresponding
to the current day. Complete/confirm visit data and click Save
To run the test
1. From OMNIA software, enter/select a subject and create/select a visit (see
above)
2. Follow all steps of subject preparation, according to section 4.3.6.

3. Create a new test by clicking on from the Database, or Testing from

Home panel
4. Click Metabolic and choose Cardiopulmonary Exercise Testing then choose
Breath-by-Breath or Mixing Chamber according to the test to be
performed.
5. Click Start and enter the required information in the prompt. These
include, but are not limited to, the test type (maximal or submaximal),
protocol and auxiliary devices (ergometer, HR monitor, Physioflow, blood
pressure measuring device).
6. Click Ok to start the test or Cancel to abort.
7. Perform the test.
8. Follow the protocol steps and click Stop to stop data recording.
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.
During test execution user interacts with the device using the following software
commands:
Button Function
Start data acquisition
Stop data recording, do not proceed, do not enter recovery
Pause the current protocol. Do not record data nor proceed

with protocol
Manually adjust the phase of the test
Insert a text marker into the data. A field will pop-up to enter
the text

Manually record Blood Pressure (automatic or manual entry)
Select the RPE value for Dyspnoea
Select the RPE value for Leg Pain
Indicate that Arterial Blood Gas measurement or Lactate was

taken (edit after test)
Select to perform an Exercise Flow Volume Loop
Enter recovery phase
Cancel the test and do not save any data
Exit from real-time test interface
Note: Exercise Flow Volume Loop manoeuvre cannot be executed neither in mixing
chamber mode nor in BxB mode if masks with inspiratory valves are used.
5.2.5 Test Edit and Report

With OMNIA, users can store an unlimited number of tests. Tests stored in the
Database can be reviewed for data editing and reporting. Several editing features
and report customization options are available.
For test edit and reports functions refer to OMNIA reference manual.
5.2.6 Download tests to OMNIA

The Download Test panel can be accessed by clicking on the Database tile from
OMNIA Home panel and allow the transfer of tests from K5 unit to the OMNIA
database.
The following buttons are available:

Buttons Description
Read data from the connected device and show all tests stored
on the device
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 Download Tests
1. Make sure the K5 device is properly paired with the software (see section
2.3.5 or 2.3.6).
2. Clicking on to populate the left side of the panel with all tests stored on
the connected device. If necessary, the list can be filtered by toggling the
Select New Test Only button.
3. Select the tests to be transferred. Use the dedicated search bar to browse
tests on the device.
4. Click if you wish the selected tests to be imported to a new subject in
the OMNIA database or
5. Click if you wish to link the selected tests to an existing subject in the
database. Use the dedicated search bar to browse subject in OMNIA
database.
5.2.7 Backup Database

Backup Database utilities is available for OMNIA standalone version only can be
accessed by clicking on the Utility tile from OMNIA Home panel.
By clicking on Backup the backup starts and a progress bar shows the operation
status.

Backups are stored at the following destination:

C:\Users\Public\Documents\Cosmed\CosmedLab\Backups.
Destination can be reviewed in the filesystem by clicking on .
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).
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 stored in a safe place.
Note: For OMNIA network version the database backup is not managed by
OMNIA but the IT department shall perform it on server.

Maintenance
Maintenance COSMED Srl
6.1 Overview
To keep K5 clean, safe and efficient, it must be properly maintained as outlined in

this section.
• Any service operations not specified in this manual should only be
performed by authorized personnel, in accordance with the service
manual.
• The device must not be serviced or maintained while in use with a subject.
• The device should be turned off with the power cable disconnected and
gas cylinder closed by means of the dedicated ON/OFF valve prior to
cleaning, disinfecting, maintaining, servicing and/or inspecting the device.
• Dispose of all parts removed from the device according to your institution’s
protocol. Follow all local, state, and federal regulations with respect to
environmental protection, especially when disposing of the electronic
device or parts of it (for example, oxygen cell, scrubber, batteries).
• After any maintenance procedure check that the device is restored to the
conditions necessary for intended use.
6.1.1 Recommended Maintenance Schedule

Maintenance Recommended Note Performed by
Procedure Interval
Cleaning and N/A Refer to the Cleaning and Expert
disinfection Disinfection user manual
Sampling line After 100 tests Store the sampling line in a Expert
Replacement or 6 months clean place. Tag the sampling
(whichever line with a label indicating the
comes first) date of first use
CO2 Scrubber 12 months or CO2 scrubber colour tends to Expert
when warning purple when exhausted
message is
displayed
Air inlet filter 12 months Expert
Replacement

COSMED Srl Maintenance
O2 Sensor 12 months or GFC O2 Cell will degrade over Expert

Replacement when warning time even if the K5 is not used
message is
displayed
Battery 12 months or Li-Ion batteries lose Expert
Recalibration when battery approximately 5% capacity per
capacity gauge 100 cycles and an additional 5%
gets unreliable per year
Calibration 3L 12 months Refer to section 6.6 Expert
syringe
recalibration
Battery When discharge Check battery discharge time in Expert
Replacement time at full Utility /QC/ Battery Status.
charge is < 2 Before proceeding with battery
hours replacement, check whether
battery recalibration improves
battery performances.
Firmware update When available Check cosmed.com for updates Expert
OMNIA When available Check cosmed.com for updates Expert
Software update and refer to OMNIA Reference
Manual
Device Visual After extensive Expert
Inspection use of the
equipment or
after a long
period of
storage in
unfavourable
conditions.
Preventive 12 months A Functional Check is also Service
Maintenance performed to certify the Personnel
functioning of the device.
Refer to section 6.10
Advanced Upon request Verification of accuracy. Service
Services Personnel
Refer to section 6.11

6.2 Cleaning and Disinfection
Disposable items that can be used with K5 device are listed below.
Note: Single use parts must not be reused and must be properly disposed of
immediately after use, according to local/institute legal provisions.
6.2.1 Disposable Items

REF Description Image
A-182-300-004 Antiviral and antibacterial filter,
round mouthpiece
A-182-300-005 Antiviral and antibacterial filter,

oval mouthpiece
A-662-100-001 Nose Clips
C00568-01-98 Mouthpiece
A-800-500-001 Mouthpiece with Saliva Trap
6.2.2 Reusable Parts

For cleaning and disinfection procedures required on reusable parts and for a
complete list of the reusable parts refer to the Cleaning and Disinfection User
Manual.
Note: Device and reusable parts are NOT supplied cleaned. Perform cleaning and
disinfection procedure prior the very first use.

6.3 Sampling line replacement
Sampling line must be replaced after 100 tests or 6 months (whichever comes first).
Sampling line replacement can also be required due to misues:
• DO NOT bend, squash or deform the sampling line.
• DO NOT expose sampling line to open air. The sampling line should be kept
sealed in a bag and in a dark place.
• If saliva enters the sampling line, replace it immediately
• If water condensation is found on sampling line at the end of tests, replace
it immediately
Note: It is recommended to swap sampling lines between consecutive tests to

allow drying and maintain sampling line efficiency.

6.4 O2 Sensor Replacement
The installation of the O2 sensor is necessary in the following situations:

• Before first use when K5 is supplied without the O2 sensor installed.
• The message “O2 sensor exhausted” is displayed during gas analyzer
calibration
• The O2 sensor has been installed more than 12 months ago.
Note: When replacing the O2 sensor, it is recommended to also replace the

sampling line.
To replace the O2 sensor

1. Power off the K5 and unplug it
from main power source (if
connected)
2. Remove the O2 cap with the
proprietary key (align the arrow
with the end of to unlock)

3. Remove the 3-pin connector from

the sensor by gently pulling the
white cable
4. Remove the O2 sensor holder
5. Pull up the old sensor by means

of a tool (for example, pliers)
6. Insert the new O2 sensor into the

dedicated slot
7. Re-insert the O2 sensor holder
8. Connect the 3-pin connector to
the sensor
9. Reinstall the cap with the
proprietary key (align the arrow
with the symbol and turn the
cap as far as the symbol). The
cap should be secured tightly.
10. Calibrate the sensor to ensure
proper functionality.
Note: The GPS module is connected to the O2 cap and it may be necessary to
disconnect it for a smooth O2 replacement procedure. If you disconnect the
GPS module, remember to reinstall it before closing the O2 cap at the end
of the procedure.

6.5 Battery Recalibration
Battery recalibration resets the battery indicator to match the current capacity.
As batteries age and are used, the available capacity shrinks. Therefore, with each
charge cycle (charge/discharge), the battery life decreases a little. On average, Li-Ion
batteries lose 5% capacity per 100 cycles and an additional 5% per year.
The indicator provides information about the remaining charge of the battery as
well as “Max-Error”, the accuracy of the estimated capacity. Recalibration re-sets
the indicator to match the actual battery capacity of the battery. Therefore, as the
battery ages the accuracy and reliability of the indicator will be accurate throughout
the life of the battery.
To recalibrate the battery
Recalibration consists of a charge, followed by a calibration discharge. Finally the
battery is given a regular charge. The recalibration procedure is faster if the battery
is fully charged from the beginning.
1. Insert battery in charger
2. Red LED indicates recalibration is necessary, proceed with recalibration or
just charge battery
3. Press the calibration button for the battery to be recalibrated. If the button
is not pressed, the charger will automatically begin to charge the battery.
4. The blue LED will flash indicating that the battery is being recalibrated. Do
not touch the battery or any battery charger buttons during the calibration
as this will reinitiate the process.
5. At the end of the calibration the blue LED will stay constant indicating a
fully calibrated fuel gauge.
The entire procedure takes between 25-31 hours requiring multiple
charge/discharge cycles
Note: During recalibration, the charger may become warm.
Note: Batteries should be replaced when can no longer maintain charge for 2
hours (50% of expected time). Contact technical support for replacement
options.

6.6 Calibration 3L syringe recalibration
Calibration syringes come with a calibration certificate which is valid for one year
from first use. Users should indicate the date of first use on the paper included in
the package, because it may differ from the date reported on the calibration
certificate. After the expiration time, the syringe shall be shipped to COSMED for
calibration certificate renewal.

6.7 K5 Firmware Update
Embedded software of the K5 device (also known as “firmware”) can be updated by

the user using a SD card.
Note: The SD card must be SDHC with a maximum storage capacity of 32 GB,
formatted FAT32
6.7.1 Preparing the SD card

1. Connect the SD card to a computer
2. Download the Firmware update file
3. Unzip the downloaded zip file content into the root directory of the SD
card, this will create a directory named _cosmed containing some binary
files
4. Safely eject the card from the computer
6.7.2 Firmware Installation

Note: The firmware upgrade process will erase all data stored on the K5.
Download all tests to your PC before upgrading
1. Power off the K5

2. Lift tab, twist and remove the battery cover
3. Ensure that the battery has at least 20% remaining (1 block)
4. Insert the SD card with the new firmware into the SD slot, DO NOT force it,
it will only go in one way
5. Power on the K5. The firmware update begins automatically
Note: The firmware update takes several minutes, DO NOT interact or power off
the K5 during the process
6. The K5 will automatically restart once the process has finished

7. Remove the SD card
8. Reinstall the battery cap

In the unlikely event of failure, repeat the process before following the Recovery
Mode procedure below
6.7.3 Firmware Update in Recovery Mode

K5 powers on, but the screen is black:
1. Power off the K5
2. Remove the battery cap and the O2 cap
3. Ensure that the battery has at least 20% remaining (1 block)
4. Insert the SD card with the new firmware into the SD slot, DO NOT force it,
it will only go in one way
5. Using the tip of a pen or a tip, lightly press and hold down the Recovery
button while powering on the unit. The firmware update starts
automatically.
Note: The firmware update takes several minutes, DO NOT interact or power off
the K5 during the process
6. The K5 will automatically restart once the process has finished

7. Remove the SD card
8. Reinstall and tighten the battery cap and O2 cap
If the problem persists, make sure you are using the original SD card provided by
COSMED with the system and repeat

6.8 K5 License Update
Additional hardware/software functions can be added to K5 which require

activation. Activation keys are encrypted and stored in the non-erasable section of
the internal memory of the device.
Note: License activation can be only performed by connecting K5 to a PC with

OMNIA Licenser via a USB cable.
6.8.1 Update K5 Licenses

1. Connect K5 to the PC via an USB cable.
2. Run the program COSMED License Manager (available from Start Menu /
Programs / COSMED / OMNIA
3. Select the tab Device Management / Device Selection.
4. Select K5 from the list of all COSMED devices and specify USB
communication port.
5. Select the tab Upgrade License
6. Click the button Load From File
7. Select the license file (*.lic) to import, click Open to confirm.
8. Click the button “Upgrade”
9. Repeat the above steps for all the license files received.
10. Reboot device by holding the power button (wait 15-20 seconds to power
back on).

6.9 Device Visual Inspection
The device requires recurrent visual inspections to be carried out to ensure proper
electrical and mechanical safety levels.
Inspections are recommended after extensive use of the equipment or after a long
period of storage in unfavourable environmental conditions.
The equipment should be turned off and adapters should be disconnected from the
power supply when inspecting the materials.
Contact COSMED Customer Support to replace parts, if needed.
Device frame
• Verify the K5 has no cracks or dents.
Labelling
• Verify that the labels are present and that they can be fully readable; a
damaged/non-readable label might void Quality certifications and
Warranty. Labels may become discoloured or detached over time.
Cables, plugs, pneumatic tubes
• Verify the integrity status of the insulation materials of cables, plugs and
any other visible parts.
• Verify gas tubes are not fissured or stressed.
Flowmeters
To inspect the flowmeters, perform the following procedure:
• Verify that the turbine axis fits correctly and the blade is fastened on the
axis (you can lightly shake the turbine to note any anomalous movement).
• Verify that turbine blades are not bended and rotate freely.
• Verify that the turbine clear plastic is not getting opaque.
• Verify that the turbine plastic housing does not have signs of cracks.

6.10 Preventive Maintenance
The Preventive Maintenance is a high-level service which must only be performed

by authorized distributors or by Service Personnel.
It must be performed annually to guarantee the proper functioning of the Quark.
This might include but is not limited to:
• A full cleaning and disinfecting cycle.
• Replacement of consumables (CO2 scrubber, sampling line, O2 sensor) and
reusable parts, if needed.
After cleaning/disinfection and parts replacement, a Functional Check is performed
and is always required to ensure and certify the functioning of the device as per
Manufacturer’s specifications. The Functional Check verifies:
• The sampling flow is in range (adjusted if not).
• The pneumatic circuit has no leaks or occlusions (fixed if yes).
• Flowmeters and Gas sensors’ performances, through a set of dedicated
calibrations. This is also intended to verify their residual lifespan and
potentially reducing expensive and/or unexpected damages.
• The global performances of the measuring device via the execution of a
Simulated test.
• Electrical safety through the execution of an Electrical Safety test.

6.11 Advanced Services
The Advanced Services can be performed upon request. They consist in

supplemental verifications of accuracy performed by dedicated testing simulators to
certify the system is in full compliance with the latest international guidelines.

Troubleshooting
Troubleshooting COSMED Srl
7.1 Miscellaneous Problems

Problem Cause Corrective action
K5 does not turn ON Battery not present Insert a fully charged battery;
Rechargeable battery Check if power adapter is
completely discharged properly powered (green led
Power adapter not providing is ON) and connected to K5
power
K5 behaves erratically / Rechargeable battery fully Insert a fully charged battery
shuts down discharged
Battery life is shorter Battery requires re- Recalibrate Battery;
than usual calibration or is completely Replace Battery
exhausted
Date and time are not Internal backup battery is Contact technical support as
stored when battery is exhausted soon as possible to replace
replaced the internal battery
Internal backup battery is
damaged
K5 freezes or reacts Archive, program memory or Download test data;
erratically during firmware is corrupted Erase database;
normal operation
Update K5 Firmware (check
latest version on
www.cosmed.com)
Omnia freezes during With some HW/OS Stop CosmedLab.exe (via Task
Bluetooth® pairing configurations, Omnia Manager) and restart OMNIA
does not receive
confirmation message from
operating system even
though pairing process has
been successfully
completed.
Unable to pair Several possible causes Refer to OMNIA Reference
Bluetooth® Manual

COSMED Srl Troubleshooting
Heart Rate is not HR belt internal battery Check/replace HR belt internal

detected exhausted; battery;
HR belt not properly worn or Place HR belt according to
extremely dry skin; 4.3.6 section;
HR belt (ANT+™/BLE) not If more than one ANT+™/BLE
paired; monitor is used in the same
Specified “HR source” in area, pair K5 to desired one as
Omnia software not suitable described in 3.2;
(HR is shown on K5 display, Select HR source as
not detected by OMNIA “Metabolic Cart“ under
software). Integrated Devices when
starting a Metabolic test from
OMNIA software.
Data from ANT+™ Device profile has not been Check correspondding device
sensors are not enabled profiles are enabled in
displayed in OMNIA Settings/ANT+™;
ANT+™ sensor was not
active when test started Activate sensors just before
(most sensors only activate starting the test by moving
when moved and pairing them;
occurs at the beginning of Replace sensor battery;
the test!)
Enable ANT+™ parameters in
ANT+™ sensor battery is low OMNIA
Data from ANT+™ Poor RF conditions for test Isolate test environment from
sensors are displayed environment; RF interference as much as
intermittently in OMNIA possible;
ANT+™ sensor battery is low
Replace sensor battery.
Calibration values out One or more calibration Repeat gas calibration with a
of range factors are outside fresh sampling line, if
acceptable range, as available.
reported in section 3.4.8. Access Calibration/Cal. Factors
menu, compare results with
acceptable ranges and contact
customer support providing
details about parameters
outside of range

K5 powers ON, but the Firmware is corrupted Firmware update in recovery

screen is black mode
Subject is breathing, but K5 is not detecting breaths Inspect turbine and
no values are displayed (Flow, Volume or IN/EX) optoelectronic reader
on LCD because: assembly;
-turbine flowmeter and Replace turbine flowmeter;
optoelectronic reader not Replace optoelectronic
properly assembled; reader;
-electronic reader not Check Sampling line condition
properly connected; and connection
-turbine rotor does not
rotate;
-optoelectronic reader is
broken;
- Sampling line not
connected
Subject is breathing, but K5 does not detect breaths See above;
no values are shown in (see above); From OMNIA, access
OMNIA
K5 detects and transmits Settings/CPET and disable
breaths which are “accepted range” filter then
considered invalid by restart the test. Analyze
OMNIA; received breath values for
Wireless link lost further troubleshooting;
End test from K5 and
download test data to OMNIA
Gas calibration and/or O2 sensor incorrctly Check O2 sensor installation
VO2, VCO2 values out of installed; following section 6.4.
range after O2 sensor
Air leak
replacement
GPS data not received GPS satellites not “visible”; GPS can operate properly only
GPS module disconnected outdoors;
GPS module is located inside
of the O2 sensor cap; make
sure it has been properly
reconnected following O2
sensor replacement

VE values are low Mask leak occurring during Select proper mask size
exhalation; according to section 4.3.6.
Flowmeter adapter not Check face mask is properly
properly assembled on the placed and head cap
mask affecting inspiratory tightened;
valve operation Perform mask Leak Test, refer
to section 4.3.6
Make sure flowmeter adapter
is assembled according to
section 4.3.6
VO2, VCO2 values Miscellaneous factors Repeat all calibration
different from expected procedures according to
instructions;
Access Calibration/Cal. Factors
menu, compare results with
acceptable ranges and contact
customer support providing
outside of range.
Summarize results of in
vivo/in vitro comparison
studies in a comprehensive
format before contacting
customer support
Sample pump is Sample circuit occluded Replace sampling line;
extremely loud
Contact customer support
Water drops Sample line exhausted, Replace sampling line
accumulated in sample unable to remove humidity
line at the end of a test from exhaled gas
Pulse Oximeter Communication problems Power off the Pulse Oximeter
WristOx2 3150 stops and power it back on
transmitting SpO2 and
HR data
Pulse Oximeter Sensor is not bonded Disconnect and reconnect
WristOx2 3150 BLE is sensor’s battery, then repeat
paired but no values are the pairing procedure
displayed on LCD screen according to section 3.2.5

7.2 Error Messages and Notifications

Message Cause Corrective action
Warming up in progress. XX Test or calibration is Wait for the recommended
minutes remaining. launched during warm- warm-up (ignoring the
Proceed anyway? up period (it varies message could lead to
according to different inaccurate results).
test and calibration
modes).
Scrubber calibration Scrubber calibration Perform a Scrubber calibration
recommended. expired before proceeding with test
Proceed anyway? (ignoring the message could
lead to inaccurate results).
BxB Gas Calibration BxB Gas calibration Perform a BxB Gas calibration
Mix Gas Calibration Mix Gas calibration Perform a Mix Gas calibration
Delay Calibration Delay calibration expired Perform a BXB and Delay
recommended. calibration before proceeding
Proceed anyway? with test (ignoring the
message could lead to
inaccurate results).
Calibration FAILED Several causes Repeat the calibration; if the
problem persists, contact
service.
Calibration FAILED Impossible to complete Be sure the tank is not empty
Reference Gas from Tank BxB and Delay or Mix or closed.
Not Detected Gas Calibration due to Be sure that sampling line is
absence of reference connected to the tank when
Gas. requested.

Calibration FAILED Breathing rate during Repeat the calibration keeping

Frequency too high Delay calibration too a lower breathing rate
high
Calibration FAILED Breathing rate during Repeat the calibration keeping
Frequency too low Delay calibration too a higher breathing rate
low.
Calibration FAILED Sensor speed factor is Repeat the calibration; if the
Speed Factor Out of Range outside acceptable problem persists, contact
range, as reported in service.
section 3.4.8.
Calibration FAILED Flowmeter calibration Check the flowmeter
Max Number of Strokes failed connection.
Reached Be sure that flowmeter is free
to move.
Cal Factors Out of Range, One or more calibration Access Calibration/Cal. Factors
Accept the Calibration? factors are outside menu, compare results with
acceptable range, as acceptable ranges and contact
reported in section 3.4.8. customer support providing
outside of range
Scrubber Not Detected or Scrubber has not been Be sure to connect the
Exhausted, Continue? detected during Scrubber when requested.
calibration procedure or Replace the scrubber if
is unable to remove CO2 exhausted.
from room air
FiCO2 too high, Continue? Environmental CO2 Make sure room is properly
detected during aerated before performing
calibration too high calibration and test
(>0.15%)
O2 Sensor signal Poor, O2 sensor is exhausted; Replace O2 sensor according
Continue? to Install/replace O2 sensor;
O2 sensor disconnected;
Calibration performed at Check electrical connection to
very high altitude the O2 sensor;
Ignore warning message at
high altitude

O2 trimmer error! O2 sensor cannot be Repeat the calibration; if the

calibrated problem persists, contact
service.
Volume Out of Range Volume measured during Repeat the calibration; if the
Flowmeter calibration is problem persists, contact
outside acceptable service.
range.
Error exporting test. Error occurred during Repeat the operation. Try with
Please, remove SD Card test export procedure. a different SD card.
Database will be deleted. User decided to erase Before proceeding, consider
Continue? the Database. that the operation is
unrecoverable (all data will be
lost!)
***Error erasing An error occurred during Turn the device off and try
database*** database erasing again.
function If problem persists, reinstall
internal SW according to
maintenance instructions (all
stored data will be lost!)
Battery too low for testing Remaining capacity of Replace the battery with a
the Battery is too low to charged one, or charge the
perform a test. battery before proceeding.

Appendix
Appendix COSMED Srl
8.1 EMC Conformity
Emission limits
Phenomenon Applied EMC standard Emission level
Conducted and radiated RF CISPR 11 Class A
emissions
Voltage fluctuation and flicker IEC 61000-3-3 Pst<1
Dc<3.3
Dmax<4
Tmax<0.5
Note: The EMISSIONS characteristics of this equipment make it suitable for use in
industrial areas and hospitals (CISPR 11 class A). If it is used in a residential
environment (for which CISPR 11 class B is normally required) this
equipment might not offer adequate protection to radio-frequency
communication services. The user might need to take mitigation measures,
such as relocating or re-orienting the equipment.
Enclosure port immunity

Phenomenon Applied EMC standard Immunity test level
Electrostatic discharge IEC 61000-4-2 ±8 kV contact
±2 kV, ±4 kV, ±8 kV, ±15 kV
air
Radiated RF EM fields IEC 61000-4-3 3 V/m (before modulation)
80 MHz - 2.7 GHz
80% AM at 1 kHz
Proximity fields from RF IEC 61000-4-3 See following table
wireless communications
equipment
Rated power frequency IEC 61000-4-8 30 A/m
magnetic fields
50 Hz or 60 Hz

COSMED Srl Appendix
Enclosure port immunity to RF wireless communications equipment

Test frequency Modulation (with Max power Distance (m) Immunity test
(mHz) a 50% duty cycle) (W) level (V/m)
385 Pulse modulation 1.8 0.3 27
18 Hz
450 Pulse modulation 2 0.3 28
18 Hz
745 217 Hz
780
870 18 Hz
930
1845 217 Hz
1970
217 Hz
5500 217 Hz
5785
Input A.C. power port

Phenomenon Applied EMC standard Immunity test level
Electrical fast transient / IEC 61000-4-4 ±2 kV
bursts
100 kHz repetition
frequency
Surges line-to-line IEC 61000-4-5 ±0.5 kV, ±1 kV
Surges line-to-ground IEC 61000-4-5 ±0.5 kV, ±1 kV
Conducted disturbances IEC 61000-4-6 3 V r.m.s. 0.15 MHz - 80
induced by RF fields MHz
6 V r.m.s. in ISM bands*
80% AM at 1 kHz
Voltage dips IEC 61000-4-11 0% UT: 0.5 cycle

Appendix COSMED Srl
At 0°, 45°, 90°, 135°, 180°,

225°, 270° and 315°
0% UT: 1 cycle and
70% UT: 25/30 cycles
Single phase: at 0°
Voltage interruptions IEC 61000-4-11 0% UT: 250/300 cycles
*ISM bands: 6.765 MHz to 6.795 MHz, 13.553 MHz to 13.567 MHz, 26.957 MHz to
27.283 MHz, 40.66 MHz to 40.70 MHz

COSMED Srl Appendix
8.2 IEC 62353 Safety Test
Note: These tests can be performed by service personnel only. Competence shall
include training on the subject, knowledge, experience and acquaintance
with the relevant technologies, design standards and local regulations. The
personnel assessing the safety shall be able to recognize possible
consequences and risks arising from non-conforming equipment.
IEC 62353 safety test provides a method of determining if potential health hazards
to the subject or user of the device exist.
This test shall be executed in the following cases:
• Before putting the device into service
• After repair (if applicable, see Service Manual for further details)
• Recurrent safety tests, if planned
The recommended interval for IEC 62353 testing is 24 months, unless differently
specified by the local laws.
After the IEC 62353 safety test check that the device is restored to the conditions
necessary for intended use
References
IEC 62353 Medical electrical equipment – Recurrent test and test after repair of
medical electrical equipment.
Test equipment and conditions
The test equipment required to perform electrical safety tests is listed below.
• Safety Analyzer / Leakage Current Tester conforming to IEC 62353
Refer to the instructions delivered with the safety analyzer to perform each test.
Visual inspection
Special attention shall be paid to the following:
• Safety related marking, labels and labelling are legible and complete
• The integrity of mechanical parts
• Any damage or contamination
• Assess the relevant accessories together with the device

Appendix COSMED Srl
• The required documentation is available and reflects the current revision

and/or configuration
Equipment leakage current
The Equipment Leakage Test measures the total leakage deriving from the Applied
Parts, Enclosure and Mains Parts.
The test is conducted in accordance with the schematics reported in IEC 62353.
Applied parts leakage shall be performed on both mains and battery power
operating mode.
Test Equipment leakage current
Classification Class II, internally powered equipment, BF
Applied parts
Applied parts (BF) Optoelectronic Reader + Face-mask
Equipment acceptance criteria 100uA (Normal, Reversed mains)
Applied Parts acceptance criteria 5000uA (Normal, Reversed mains, battery
oper.)

COSMED Srl Appendix
8.3 Warranty and Service Policy
Warranty and Limitation of Liability

COSMED equipment comes standard with a one-year limited warranty from the
original date of sale of the product. COSMED products are guaranteed to be free
from defect upon shipment. Liability for products covered by this warranty is limited
to the replacement, repair, or issuance of a credit for the cost of a defective product
at the discretion of COSMED.
The following conditions must exist for the warranty to apply:
1. COSMED is promptly notified in writing by the buyer upon the discovery of
defect and within warranty terms
2. The defective product is received by COSMED no later than four weeks
after the last day of the one-year warranty period
3. COSMED’s inspection of the defective parts confirms that the defect was
not caused by misuse, neglect, improper installation or an unauthorized
repair or alteration
If the product is manufactured by a third-party, the warranties provided the third-
party manufacturers will be the only ones available for the buyer. COSMED hereby
does not warranty or assume any liability from defects or damages to and/or caused
by products manufactured by a third-party. The buyer must obtain written
authorization from COSMED prior to the repair or alteration of any COSMED
products. Failure to obtain written authorization will result in a void of the
warranty.
The limited warranty shall not be enlarged, diminished or modified by the
renderings of technical service from COSMED’s agents or employees when the
product is ordered or following the use of the product(s).
Unauthorized Operations
Unauthorized access to the internal components of the system can irreparably
damage the system. This unauthorized access will void the warranty of the device.
Return goods policy for warranty or non-warranty repair
Products shipped to COSMED for repair are subject to the following conditions:
• Products may only be returned upon receiving a written authorization by
COSMED technical support (RMA - Return Merchandise Agreement).

Appendix COSMED Srl
• Customer is required to fill in the Check-in/out form, with specific

reference to the “Customer Checklist” column. Check-in/out form must be
printed, and a copy included into the cardboard box.
• Products may only be returned according to the instructions provided by
COSMED technical support, after decontamination according to Cleaning
and Disinfection User Manual.
• If you must ship the device, use the original packing materials. If the
original packaging is no longer available or damaged, wrap the device in
multiple layers of bubble wrap so that a cushioning layer protects it, or
contact your COSMED representative for replacement materials.
• If archive memory contains subjects’ sensitive data, erase database before
returning the unit.
Note: Do not include the internal battery when air-shipping (if installed, remove it
from the device).

COSMED Srl Appendix
8.4 Other Information
8.4.1 Environmental Condition of Use

COSMED units should not be operated near explosive substances.
Equipment should not be installed near electrical or magnetic devices such as x-ray
equipment, transformers or power lines. These devices could create electrical
interferences when performing testing procedures. COSMED devices are not AP or
APG units (according to IEC 60601-1) and should never be operated in the presence
of flammable anesthetic mixtures.
• Temperature range: 0°C (32°F) to 40°C (104°F)
• Relative humidity range: 5% to 90% (non-condensing)
• Atmospheric Pressure range: altitude from sea level to 4850m
• Avoid operating equipment in the presence of noxious fumes or in dusty
environments
• Do not place K5 near heat sources
• Adequate ventilation should be maintained in the room the testing is
performed
Note: Power Supply (C04118-01-30) is certified to operate up to 3000m (9800 ft),

Dual Battery Charger AC/DC Adapter (C04267-01-10) to 2000m (6500 ft).
8.4.2 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.com
Internet: www.cosmed.com
Worldwide COSMED offices are listed in corporate web page

www.cosmed.com/en/contact-us

Appendix COSMED Srl
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
8.4.3 Privacy Information

Refer to Privacy disclaimer reported in corporate web site:
https://www.cosmed.com/en/company/privacy
8.4.4 Disposing of Electrical Equipment

The device cannot be disposed as unsorted municipal waste.
Electronic equipment must be collected separately according
to the European Directive 2012/19/EU. Otherwise it can cause
dangerous consequences for the environment and human
health.
The crossed-out wheeled bin means that the product must be
taken to a separate collection when you wish to dispose of it.

COSMED Srl Appendix
8.5 Parts List
The main parts compatible with the device are listed in this section. For additional
parts you may contact COSMED Customer Support (see section 8.4.2)
8.5.1 Standard Configuration

C09090-02-99 K5 Wellness unit
A-201-500-032 K5 Trolley Suitcase Waterproof Case
C04320-01-05 Harness
A-661-200-096 HR Module w/ elastic strap
A-800-900-023 V2 Mask – Head Cap (Small, Medium)
A-800-900-022 V2 Mask – Head Cap (Large)

Appendix COSMED Srl
C04324-04-10 V2 Mask w/ inspiratory valve for

turbine 2000 (Xsmall)

turbine 2000 (Small)

turbine 2000 (Medium)
C02120-01-05 Turbine 2000
C02107-02-08 Wind shield
C04020-01-04 Opto-reader 2000
C02106-02-08 Opto-reader 2000,

Mouthpiece/syringe adapter
C04267-01-10 Dual battery charger (w/ AC/DC

adapter)
C04118-01-30 Power supply AC/DC adapter, K5
C04117-01-12 Cable, USB K5

COSMED Srl Appendix
C04432-01-30 K5 Earphone
C04971-01-10 Air calibration extension line
C04300-01-20 O2 sensor key
8.5.2 Options and Spare parts

A-860-000-004 CAL Gas Metabolic Mix CGA-973
(16%O2, 5%CO2, N2 bal)
A-870-150-012 Regulator K5, MET Mix (outlet CGA-

973) – for E size cylinders
A-870-600-001 Regulator K5, MET Mix (outlet UNI

4410) – for H size cylinders
C01800-01-05 External calibration unit
C00600-01-11 Calibration syringe 3 liter

Appendix COSMED Srl
C04108-01-06 Polar® Heart Rate (HR) receiver (non-

coded)
A-661-200-001 Polar® Heart Rate Monitor Chest Strap
A-661-200-002 Polar® Heart Rate Monitor (HRM)

transmitter
A-661-600-018 Nonin® 3150 Wrist Bluetooth®
oximeter*
C04109-01-12 Optoisolated HR interface (for TTL ECG)
A-497-500-004 Battery Car Charger 1-slot w/ cigarette

lighter plug
A-860-900-003 Cylinder stand for ED cylinders with

thumbscrews
A-661-110-002 Foot sensor (stride & cadence)
A-244-350-001 K5 mount adapter, clamp for

bike/treadmill handlebars
C03620-01-10 V2 Mask for VO2max flowmeter

(Petite)

(Xsmall)

COSMED Srl Appendix
C03611-01-10 V2 Mask for VO2max flowmeter (Small)

(Medium)
C03613-01-10 V2 Mask for VO2max flowmeter (Large)
C05085-01-20 Mask/filter Adapter
C02155-02-08 Opto-reader 2000, closing ring
A-800-900-024 Head cap Paediatric for V2 Mask

(ExtraSmall, Petite)
C04470-01-11 Aquatrainer (Requires ref C04480-02-

11 K5 Product Kit)
C04270-01-11 K5 MODULE - Long Distance

Bluetooth® TX/RX.
Wireless data transmission to 1000
meters
OMNIA Software Modules:
A-670-100-023 OMNIA AUX
Devices Integration
A-670-100-010 OMNIA Misc
Ergometers Drivers

Appendix COSMED Srl
K5 Modules
C04271-01-11 IntelliMET Dual
sampling technology, Mix + BxB
C04272-01-11 ANT+™ Engine
Disposables
A-182-300-004 Antibacterial Filters, round
mouthpiece (50 pcs)
A-182-300-005 Antibacterial Filters, oval mouthpiece

(50 pcs)
A-662-100-001 Nose Clips

(25 pcs)
C00568-01-98 Mouthpiece
(200 pcs)
A-800-500-001 Mouthpiece with Saliva Trap
Maintenance parts
C04254-01-08 Permapure drying sample line - K5
C04273-01-05 Battery pack, K5 (Li-ion 7.2V w/ LCD)

COSMED Srl Appendix
A-558-250-005 Gas Sensor, O2 GFC
C04408-01-07 CO2 absorber, K5
8.5.3 Replacement and Re-orders

To place part orders or replacements please refer to your local distributor or
contact manufacturer (see section 8.4.2). For parts covered by warranty please refer
to section 8.3.

Appendix COSMED Srl
8.6 Safety and Conformity
Safety
IEC 60601-1/EN 60601-1;
The complete classification of the device is as follows:
Class II, with BF type applied parts
Protection against water penetration: IP54
Non-sterile device
Device not suitable in the presence of flammable anesthetics
Continuous functioning equipment
EMC
The system meets the standard IEC 60601-1-2
Telemetry
ETSI EN 301 489-1, ETSI EN 301 489-3, ETSI EN 301 489-17
ETSI EN 300 328
ETSI EN 300 440-2
EN 62479 (Max power <20 mW)
Company Quality Assurance standards
UNI EN ISO 9001:2015 (Registration n° 387-A Kiwa Cermet)
UNI EN ISO 13485:2016 (Registration n° 387-M Kiwa Cermet)
FCC/IC
The K5 complies with the following requirements:
FCC (Federal Communications Commission) Part 15
IC (Industry Canada) ICES-003
Operation is subject to the following two conditions:
(1) This device may not cause harmful interference, and
(2) This device must accept any interference received, including interference that
may cause undesired operation
Changes or modification not expressly approved by the party responsible for
compliance could void the user’s authority to operate the equipment

COSMED Srl Appendix
FCC ID: SN7-COSMED-K5

IC: CAN ICES – 3 (B)
Note: Equipment has been tested and classifies as a Class B digital device, based
on part 15 of the FCC Rules. These limits are designed to provide reasonable
protection against harmful interference in a residential
installation. This equipment generates, uses and can radiate radio
frequency energy and, if not installed and used based on the instructions,
may cause interference with radio communications. If the device causes
interference to radio or television reception, which can be determined by
turning the equipment off and on, the user is encouraged to try to correct
the interference by one or more of the following measures:
• Reorient or relocate the receiving antenna

• Increase the separation between the equipment and receiver
• Connect the equipment into an outlet on a circuit different from
that to which the receiver is connected
• Consult the dealer or an experienced radio/TV technician for help

Appendix COSMED Srl
8.7 Technical Specifications
8.7.1 Hardware specifications
Dimensions: 174x111x64 mm (6.8x4.4x2.5 in)

Weight: 900g (31.7 oz), including battery and O2
sensor
Display LCD: 3.5” TFT LCD transflective, 320x240 pixel,
65k colors, LED-backlit,
Display Touchscreen: Resistive technology, allows gloves and wet
fingers
Keyboard: 4 keys for main functions
CPU: 456 MHz, 128MB RAM
Storage capacity: Up to 2,048,000 breaths
SD card slot: SD-HC, MAX 32GB, FAT32 format
Power Supply (Rechargeable Battery)

Type: “Smart” Li-Ion rechargeable batteries, with
LCD charge status
Autonomy: Up to 4 hours
Nominal Capacity: 3.1 Ah
Nominal Voltage: 7.2V
Watt-hour rating: 22 Wh

COSMED Srl Appendix
Compliance CE, FCC Part 15 Class B, UL-2054, IEC-

62133:2012 2nd Edition, UN 38.3, RoHS2,
REACH, WEEE
Storage temperature and humidity limits -20°C to 60°C, ≤ 80%RH
Power Supply (mains AC/DC adapter)

Type: Medical grade (complies with IEC 60601-1,
class II)
Input: 100V-240V ±10%; 50/60Hz, 600-300 mA
Output: 12V dc, 2.5A
Battery Charger Unit

Weight: 360g (12.7 oz)
Dimensions: 58x180x122 mm (2.3x7.1x4.8 in)
Charge slots: 2 slots
Charge time: 2-2.5 hours
Input: 100V-240V ±10%; 50/60Hz, 1.4A max
Output: 24V dc, 2.71A
Flowmeter
Type: Bidirectional digital turbine (Turbine 2000)
Flow Range: 0.08-20 L/s
Flow Accuracy: ±2% or 20 ml/s
Ventilation Range: 0.08-300 L/min
Ventilation Accuracy: ±2% or 100 ml/min
Resistance: <0.6 cmH2O/L/s @ 14 L/s
Oxygen Sensor (O2)

Type: Galvanic Fuel Cell
Response time: 120 ms
Range: 0-25%, optional 0-100%
Accuracy: ±0.02% Vol.
Resolution: ±0.01% Vol.
Warm-up time: 30-60 min
Lifespan: Approximately 12 months

Appendix COSMED Srl
Carbon Dioxide Sensor (CO2)

Type: Digital infrared
Response time: 100 ms
Range: 0-10%
Accuracy: ±0.02% Vol.
Resolution: ±0.01%
Warm-up time: 30-60 min
Gas measurement
Type: Breath by breath
Micro-dynamic mixing chamber
Measured parameters accuracy *

Accuracy Specifications
Vt ±2%
VO2 ±3%
VCO2 ±3%
* comparison against independent metabolic simulator (A. Huszczuk, B.J. Whipp, K.
Wasserman - A respiratory gas exchange simulator for routine calibration in
metabolic studies. A. Huszczuk, B.J. Whipp, K. Wasserman - Eur Respiration J., 1990,
3, 465-468).
Environmental Sensors
Temperature: -40°C to +60°C
Barometer: -600 to +5500m (50 to 110 kPa)
Humidity: 0-100%
Wired Connectivity
USB USB-device (2,5 kV galvanic-isolated)
Heart Rate (AUX) Polar® HR receiver
ECG TTL port (0-5Volts, LOW logic level
<0.8V, HIGH logic level > 2.0V, minimum
input impedance 10KΩ, minimum pulse
width of HIGH logic level 2ms)

COSMED Srl Appendix
Wireless Connectivity
Bluetooth®: 2.1 + EDR Class II (Range 10 m line-of-sight)
Long range Bluetooth® (optional): 2.1 + EDR Class I (Range up to 1000 m line-
of-sight)
ANT+™ Network: Up to 8 channels
Bluetooth® Low Energy: 4.0
Navigation & Motion Sensors

GPS: 10Hz GPS/QZSS receiver - position accuracy
2.5 m, speed accuracy 0.1 m/s
Altimeter: Barometric with GPS offset
8.7.2 Embedded software specifications

Software content
The Cosmed K5 product includes the following Free Software:
• Linux Kernel 4.19, licensed under the terms of the GPLv2; Cosmed did
modify the source code.
• crosstool-ng-1.24.0, licensed under the terms of the GPLv2; Cosmed did
not modify the source code.
• psmisc-23.1, licensed under the terms of the GPLv2; Cosmed did not
modify the source code.
• u-boot-2012.10, licensed under the terms of the GPLv2 and later; Cosmed
relies on the GPLv2; Cosmed did modify the source code.
• buildroot-2019.02.8, licensed under the terms of the GPLv2 and later or
others; Cosmed relies on the GPLv2 license; Cosmed did not modify the
source code.
• qt-4.8.6, licensed under the terms of LGPLv2.1 or GPLv3 license; Cosmed
relies on the LGPLv2.1 license; Cosmed did not modify the source code.
• util-linux-2.31.1, licensed under the terms of GPLv2 or later, LGPLv2.1 or
later, BSD-3-Clause, BSD-4-Clause-UC and Public Domain; Cosmed relies on
the GPLv2; Cosmed did not modify the source code.
• rt-tests-1.5, licensed under the terms of the GPLv2 and later; Cosmed relies
on the GPLv2; Cosmed did modify the source code.

Appendix COSMED Srl
Availability of GPL licensed software

The GPL licensed software distributed along with the K5 product package can be
requested accordingly to the following offer of source code.
Cosmed offer of source code
For binaries that you physically receive from COSMED along with the K5 product
that are licensed under any version of the GNU General Public License (GPL) or the
GNU Lesser GPL, you can receive a complete machine-readable copy of the source
code by sending a written request to COSMED Srl (refer to section 8.4.2):
Your request should include:
• the name of the component or binary file(s) for which you are requesting
the source code.
• the model and Serial Number of your K5 device.
• the date you received the K5 device.
• your details (name, surname, address).
• your company name (if applicable).
• your return mailing and email address and a contact phone number (if
available).
We may charge you a nominal fee to cover the cost of the media and distribution.
Your request must be sent within three (3) years of the date you received the GPL or
LGPL covered code. For your convenience, some or all of the source code may also
be found at:
• https://github.com/crosstool-ng/crosstool-ng/archive/crosstool-ng-
1.24.0.zip
• https://sourceforge.net/projects/psmisc/files/psmisc/psmisc-
23.1.tar.xz/download
• https://mirrors.edge.kernel.org/pub/linux/utils/util-linux/v2.31/util-linux-
2.31.1.tar.gz
• https://github.com/buildroot/buildroot/archive/2019.02.8.zip
• https://mirrors.edge.kernel.org/pub/linux/utils/rt-tests/older/rt-tests-
1.5.tar.gz
• https://download.qt.io/archive/qt/4.8/4.8.6/qt-everywhere-opensource-
src-4.8.6.zip
Integral version of the licenses can be found on K5 device selecting Info/Open
Source Licenses (see section 3.1.4).

COSMED Srl Appendix
8.8 References
Pulmonology
ERS 2016:”Use of exercise testing in the evaluation of interventional efficacy: an
official ERS statement”, Eur Respir J 2016; 47: 429–460.
ERS 2007 : “Recommendations on the use of exercise testing in clinical practice”,
Eur Respir J 2007; 29: 185–209
ATS/ACCP 2003: “Statement on Cardiopulmonary Exercise Testing”, American J.
Respiratory Critical Care Medicine, Vol. 167, 211; 277, 2003
ERS 1997: “Clinical exercise testing with reference to lung diseases: indications,
standardization and interpretation strategies” European Respiratory Journal 1997;
10: 2662-2689
Cardiology
AHA 2010: “Clinician’s Guide to Cardiopulmonary Exercise Testing in Adults. A
Scientific Statement From the American Heart Association”, Circulation.
2010;122:191-225
AHA 2009: “Recommendations for Clinical Exercise Laboratories. A Scientific
Statement From the American Heart Association”, Circulation 2009; 119:3144-3161
ESC 2009: “Standards for the use of CPET for the functional evaluation of cardiac
patients”, Eur. J of Cardiovascular Prevention and Rehabilitation 2009, 16:249-267
Clinical nutrition
ADA 2006 : “Best Practice methods to apply to Measurement RMR in adults.
Systematic review”, J Am Diet Assoc. 2006;106:881-903
Sports Medicine
ACSM: ACSM’s Guidelines for Exercise Testing and Prescription-Eighth edition

Appendix COSMED Srl
8.9 Notes

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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K5

Wearable Metabolic System

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Read this user manual carefully before using the device.

K5 Wellness User Manual, Edition 15.0 (12/2021)

Copyright © 2021 COSMED

REF C04595-02-91 K5 Wellness User Manual, Edition 15.0 Pag. 1/154

Pag. 2/154 REF C04595-02-91 K5 Wellness User Manual, Edition 15.0

2.1 Preliminary Operations ............................................................................. 40

REF C04595-02-91 K5 Wellness User Manual, Edition 15.0 Pag. 3/154

3.3 Utility ....................................................................................................... 60

Pag. 4/154 REF C04595-02-91 K5 Wellness User Manual, Edition 15.0

4.3.9 Disposable and Reusable Items ................................................................ 85

REF C04595-02-91 K5 Wellness User Manual, Edition 15.0 Pag. 5/154

6.9 Device Visual Inspection .......................................................................... 117

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REF C04595-02-91 K5 Wellness User Manual, Edition 15.0 Pag. 7/154

1.1 Manual Information

1.1.1 User manual’s publishing details and revision history

1.1.2 Manual purpose

Pag. 8/154 REF C04595-02-91 K5 Wellness User Manual, Edition 15.0

1.1.3 Symbols used in this manual

1.1.4 Intended audience

REF C04595-02-91 K5 Wellness User Manual, Edition 15.0 Pag. 9/154

Note: The operations described in section 2 -Installation shall be performed by

1.1.5 Related documents

Pag. 10/154 REF C04595-02-91 K5 Wellness User Manual, Edition 15.0

1.2 Important Notices

1.2.1 Indications for use

REF C04595-02-91 K5 Wellness User Manual, Edition 15.0 Pag. 11/154

2. The following standards should be applied to ensure the accuracy of

Pag. 12/154 REF C04595-02-91 K5 Wellness User Manual, Edition 15.0

• The cylinder and pressure regulator must be closed before

REF C04595-02-91 K5 Wellness User Manual, Edition 15.0 Pag. 13/154

APG (Flammable anesthetic proof mixtures with oxygen or nitrous oxide)

Pag. 14/154 REF C04595-02-91 K5 Wellness User Manual, Edition 15.0

1.2.4 Security Information

REF C04595-02-91 K5 Wellness User Manual, Edition 15.0 Pag. 15/154

• Procedural security measures - for example, assigning only staff with a

1.2.5 COSMED Product Security Policy Statement

1.2.6 Cyber Security Requirements and Controls

Pag. 16/154 REF C04595-02-91 K5 Wellness User Manual, Edition 15.0

Network Cyber Security Measures

1.2.7 Firmware Updates Security

1.2.8 Battery (Safety, Storage, Transportation and Recycling)

REF C04595-02-91 K5 Wellness User Manual, Edition 15.0 Pag. 17/154

1.2.9 Oxygen Sensor (Safety, Storage, Transportation and Disposal)

Pag. 18/154 REF C04595-02-91 K5 Wellness User Manual, Edition 15.0

• Disconnect sensor if it is attached to any equipment.

1.2.10 Glossary of symbols

REF C04595-02-91 K5 Wellness User Manual, Edition 15.0 Pag. 19/154

Indicates the manufacturer’s The device cannot be

Pag. 20/154 REF C04595-02-91 K5 Wellness User Manual, Edition 15.0

Indicates a device that is Indicates the date when the

Indicates the date when the

REF C04595-02-91 K5 Wellness User Manual, Edition 15.0 Pag. 21/154

Read the user manual For Canada & USA: Please

1.2.11 Disposing of device parts