Cosmed Q-NRG User manual

Q-NRG™+
User Manual

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COSMED srl
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 accessories.
COSMED assumes no liability for the end user interpretation of this user 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 IEC60601-1 and IEC82079-1.
Q-NRG User Manual, Edition 4.2 (04/2020)
REF C04717-02-91
Applicable to:
rmware release 1.2
software release OMNIA 1.6.9
Copyright © 2020 COSMED
COSMED
www.cosmed.com

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Q-NRG_Manual
Chapter 1 - Get Started 7
Manual Information.........................................................................................................................................8
User manual’s publishing details and revision history.............................................................................8
Intended audience ..................................................................................................................................8
Related documents .................................................................................................................................9
Important Notices..........................................................................................................................................10
Indications for use.................................................................................................................................10
Warnings...............................................................................................................................................10
Precautions...........................................................................................................................................11
Security Information.............................................................................................................................13
COSMED Product Security Policy Statement ..........................................................................................14
Cyber Security Requirements and Controls............................................................................................14
Software Updates Security....................................................................................................................15
Battery (Safety, Storage andTransportation)........................................................................................15
Oxygen Sensor (Safety, Storage andTransportation).............................................................................16
Glossary of symbols...............................................................................................................................17
Introduction to Indirect Calorimetry ..............................................................................................................21
Device Overview ............................................................................................................................................22
Measurement Modes.....................................................................................................................................23
VENTILATOR...........................................................................................................................................23
CANOPY.................................................................................................................................................23
MASK ....................................................................................................................................................24
Q-NRG Device Diagram ..................................................................................................................................25
Main Components..........................................................................................................................................26
VENTILATOR Mode Items.......................................................................................................................26
CANOPY Mode Kit..................................................................................................................................26
MASK Mode Kit .....................................................................................................................................27
3L Calibration Syringe ...........................................................................................................................28
Gas Cylinder and Pressure Regulator.....................................................................................................28
Pole/Rail Clamp withVESA Mounting Plate...........................................................................................28
Cart .......................................................................................................................................................29
OMNIA PC software...............................................................................................................................29
Chapter 2 - Installation 31
Preliminary Operations..................................................................................................................................32
Unpack the device and check content ...................................................................................................32
Electrical safety test according to IEC 62353..........................................................................................32
Potential Equalization Node..................................................................................................................32
Charge Q-NRG .......................................................................................................................................32
Power ON and OFF.................................................................................................................................33

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Calibration Cylinder Set-up ............................................................................................................................34
Software Installation .....................................................................................................................................36
OMNIA Computer Software ...................................................................................................................36
USB Driver.............................................................................................................................................37
Authorization........................................................................................................................................37
Bluetooth® Pairing................................................................................................................................37
Chapter 3 - Q-NRG Operation 39
User Interface ................................................................................................................................................40
Home Page and Main Functions............................................................................................................40
Keyboard...............................................................................................................................................42
Device Info ...........................................................................................................................................42
Settings .........................................................................................................................................................43
International.........................................................................................................................................43
System..................................................................................................................................................43
Advanced ..............................................................................................................................................43
Printout.................................................................................................................................................44
Predicteds.............................................................................................................................................44
Maintenance.........................................................................................................................................45
Utility.............................................................................................................................................................46
Export/Import/Erase ............................................................................................................................46
Control Panel.........................................................................................................................................47
Calibration .....................................................................................................................................................49
Device Warm-Up ...................................................................................................................................49
Required Calibration Procedures ...........................................................................................................49
Calibration Menu...................................................................................................................................50
Pneumotach (VENTILATOR Mode).........................................................................................................50
Gas Analyzers (Cylinder)........................................................................................................................51
Gas Analyzers (Room Air)......................................................................................................................52
Blower/Internal Flowmeter – (CANOPY Mode) .....................................................................................52
Turbine/External Flowmeter – (MASK Mode)........................................................................................53
Calibration Results and References values.............................................................................................54
Test Overview ................................................................................................................................................56
Operating by AC Power or Battery .........................................................................................................56
Warming-up Time.................................................................................................................................56
Selecting or Entering Patient Data ........................................................................................................57
Test Mode..............................................................................................................................................57
Test Results ...........................................................................................................................................58
Disposable and Reusable Items for each Test Mode...............................................................................58
Glossary of Parameters ..................................................................................................................................60
Recommendations During Testing .................................................................................................................62

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Q-NRG Placement .................................................................................................................................62
VENTILATOR Mode.................................................................................................................................62
CANOPY Mode.......................................................................................................................................63
MASK Mode...........................................................................................................................................63
Testing in VENTILATOR Mode..........................................................................................................................64
Check List..............................................................................................................................................64
Precautions/Contraindications..............................................................................................................65
Select Patient........................................................................................................................................65
Calibrate Pneumotach...........................................................................................................................65
Setting-Up VENTILATOR Mode...............................................................................................................66
Operating Q-NRG in VENTILATOR Mode.................................................................................................68
Post-test Cleaning & Disposal................................................................................................................69
Testing in CANOPY Mode................................................................................................................................70
Check list...............................................................................................................................................70
Precautions/Contraindications..............................................................................................................71
Setting-Up Canopy................................................................................................................................71
Operating Q-NRG in CANOPY Mode.......................................................................................................72
Post-test Cleaning & Disposal................................................................................................................73
Testing in MASK Mode ...................................................................................................................................74
Check list ..............................................................................................................................................74
Selecting the Mask................................................................................................................................74
MASK Mode set-up ...............................................................................................................................75
Operating Q-NRG in MASK Mode...........................................................................................................75
Post-test Cleaning & Disposal................................................................................................................76
Edit/Export/Print Results ...............................................................................................................................77
Editing Results ......................................................................................................................................77
Exporting Results..................................................................................................................................77
Chapter 4 - OMNIA software 79
Introduction...................................................................................................................................................80
Database Management.........................................................................................................................80
Download tests to OMNIA.....................................................................................................................81
Reviewing Test Results in OMNIA ..........................................................................................................82
Execute a test from OMNIA....................................................................................................................83
Chapter 5 - Maintenance 85
Overview .......................................................................................................................................................86
Recommended Maintenance Schedule .................................................................................................86
Cleaning and Disinfection ..............................................................................................................................87
Introduction..........................................................................................................................................87
Disposable and Reusable Items for each Test Mode...............................................................................88
Reprocessing Methods for Reusable Items ............................................................................................90

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Preventive Maintenance ................................................................................................................................95
Pneumatic Cartridge Replacement........................................................................................................98
Fan lter replacement.........................................................................................................................100
Mains fuses replacement.....................................................................................................................100
O2 sensor replacement ................................................................................................................................101
Firmware Update.........................................................................................................................................104
Prepare the USB ash drive device......................................................................................................104
Install Firmware..................................................................................................................................104
Battery installation and removal..................................................................................................................105
Procedure............................................................................................................................................105
Update Q-NRG licenses ................................................................................................................................106
Update Q-NRG Licenses.......................................................................................................................106
Chapter 6 - Troubleshooting 107
Miscellaneous Problems ..............................................................................................................................108
Error Messages and Notications.................................................................................................................110
Bluetooth Troubleshooting ..........................................................................................................................115
Check for pending Windows software updates....................................................................................115
If a BTA is used, be sure that internal Bluetooth module is disabled....................................................115
Replace“CSR Bluetooth Chip”drivers with“Generic Bluetooth”drivers ...............................................115
Verify that Bluetooth Drivers are Properly Installed.............................................................................116
Uninstall Q-NRG Paired Device ............................................................................................................116
Change the USB port...........................................................................................................................117
Check for incompatible or conicting processes..................................................................................117
Disable Power Management options...................................................................................................118
Wi-Fi Network Interference.................................................................................................................118
Appendix 119
CE Declaration of Conformity .......................................................................................................................120
EMC Conformity...........................................................................................................................................121
IEC 62353 safety test....................................................................................................................................123
References ..........................................................................................................................................123
Test equipment and conditions...........................................................................................................123
Commonly used denitions within IEC 62353 (and IEC 60601) ...........................................................123
Visual inspection.................................................................................................................................124
Protective Earth resistance..................................................................................................................125
Equipment leakage current.................................................................................................................126
Warranty and Service Policy.........................................................................................................................127
Warranty and limitation of liability ....................................................................................................127
Return goods policy for warranty or non-warranty repair...................................................................127
Other information........................................................................................................................................128

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Contraindications for Indirect Calorimetry testing...............................................................................128
Environmental condition of use ..........................................................................................................128
Manufacturer’s Information ................................................................................................................128
Privacy Information.............................................................................................................................128
Disposing of electrical equipment.......................................................................................................128
Accessories/Spare Parts................................................................................................................................129
Device Versions ...................................................................................................................................129
Accessories..........................................................................................................................................129
IntelliBridge Interface..................................................................................................................................135
Connection diagrams ..........................................................................................................................136
Operating Q-NRG with Philips IntelliBridge.........................................................................................136
Compatible Philips Monitors ...............................................................................................................137
Safety and conformity .................................................................................................................................138
Technical specications................................................................................................................................140
Hardware specications......................................................................................................................140
Embedded software specications......................................................................................................143
References ...................................................................................................................................................145
Bibliography .......................................................................................................................................145
Cleaning and disinfection....................................................................................................................145
Notes ...........................................................................................................................................................146

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Chapter 1 - Get StartedCOSMED srl
Chapter 1 - Get Started

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Chapter 1 - Get Started COSMED srl
Manual Information
User manual’s publishing details and revision history
The present Q-NRG user manual provides information to use the medical devices named Q-NRG (REF
C09092-X1-99) and Q-NRG+ (REF C09092-X2-99).“Q-NRG”or “device”refer to the product line and instructions
which relate to both the Q-NRG and Q-NRG+ models; Q-NRG+ hereinafter refers to instructions, options and
applications which only relate to the Q-NRG+ model.
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 accessories) 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
modications to the owner or user of the device (including software) described herein.
COSMED will make available on request the Service Manual or other documentation that will assist the authorized
trained personnel to repair parts of the device considered serviceable by COSMED.
Whenever the Manual is updated, edition changes.
Edition Changes from previous edition [Edition 4.1 (03/2020)] Date
4.2 Updated the following sections: Glossary of symbols (UL certication)
Cleaning and Disinfection, Accessories, Hardware Specications. General
review.
April 2020
Manual purpose
The Q-NRG user manual provides information that users need for the safe and eective use and care of the device
according to the indications for use. It is important that all users 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 both Q-NRG and Q-NRG+ with the most complete conguration with the
highest number of options and accessories.
Intended audience
This user manual is intended for users who install, use, calibrate, clean, disinfect, and maintain the device.
A Service Manual (see“related documents”) is intended for users who repair the device.
Users shall be appropriately trained for the correct use of the device and shall have the necessary knowledge to
install, use, calibrate, clean, disinfect, maintain or repair the device; moreover, they shall be informed about all
hazards and risks associated with the device.
The dierent levels of users are based on the amount and type of training received, assuming they have gain proper
competence with the functions and risks associated with the device.

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Q-NRG users includes Operators, Experts and Service personnel:
User Competences Tasks
Operator Scientic knowledge of procedures, practices, and terminology
as required for performing test
Test execution (according to indica-
tions for use)
Expert For installation, calibration and ordinary maintenance technical
skills are recommended
Cleaning and disinfection is entrusted to subject matter experts
with knowledge of related procedures and local/institute
regulatory laws
Installation
Calibration
Cleaning and disinfection
Ordinary maintenance (maintenance
procedures addressed in the user
manual)
Service
personnel
Technical background and awareness on hazards and risks
associated with the performed procedures are required
Service personnel must be authorized by COSMED or COSMED
aliates
Repair
Complex maintenance (maintenance
procedures addressed in the Service
Manual)
Note: Q-NRG users are assumed to be competent with the functions and risks associated with the device.
Note: the operations described in the whole chapter Installation shall be performed by personnel competent
in each of the described activities.
Related documents
Depending on conguration, further instructions may be supplied together with the device.
• Q-NRG cart instructions for installation, use and cleaning (REF DU-COS-0001-60).
• Q-NRG clamp instructions for installation, use and cleaning (REF C04890-02-91).
• OMNIA user manual (REF C04144-02-91).
• Q-NRG Service Manual (REF C04838-02-91).
Note: Pictures shown in this manual may not exactly match your device or accessories aspect.

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Important Notices
Indications for use
The Q-NRG & Q-NRG+ portable Metabolic Monitors are indicated for the measurement of Resting Energy
Expenditure (REE) for spontaneously breathing and (Q-NRG+ only) ventilated patients, within the following
populations:
• Spontaneously breathing subjects >15 kg (33 lb) when using a canopy .
• Spontaneously breathing subjects age >6 yrs and >10 kg (22 lb) when using a face mask.
• Ventilated subjects age >10 yrs and >10 kg (22 lb).
The Q-NRG & Q-NRG+ Portable Metabolic Monitors are intended to be used in professional healthcare facilities only
(limited to ICUs for ventilated patients).
CAUTION: For United States ONLY. Federal law restricts this device to sale by or on the order of a licensed
healthcare practitioner.
Warnings
This device is NOT SUITABLE for operating in presence of ammable anesthetic gases or gases other than O2, CO2,
N2 and water vapor.
• The device is to be used by physicians or by trained personnel under the responsibility of a physician.
• The device is not intended as a continuous monitoring device for surveillance of vital physiological
processes.
• The device measures clinical parameters used to aid diagnosis and it is intended only as an adjunct device
in patient assessment.
• The device must be used in conjunction with other methods of assessing clinical signs and symptoms.
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.
To avoid the risk of electric shock, this equipment must only be connected to a supply main with protective earth.
No modication of this device is allowed.
Due to the required level of technical and patient assessment skills, measurements using Q-NRG should be
performed by users trained and competent to:
• operate and maintain the device.
• operate a mechanical ventilator (including knowledge of alarm and monitoring function).
• recognize metabolic measurement values within the physiological range.
• evaluate the results in light of the patient’s nutritional and clinical status.

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Precautions
Note the following precautions before operating the device to ensure the safety of the user and patient:
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:
• Accessories (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 oer
suggestions while using such accessories and the complications they could cause.
• Repairs or modications of the device should ONLY be performed by personnel authorized by COSMED
or COSMED aliates.
• Environmental and electrical conditions in which the device operates should be in compliance with the
specications of this manual.
• Device maintenance, inspections, disinfection and cleaning should be conducted as described in this
manual.
3. Do not use extension cords or adapters of any type. The power cord and plug must be intact and
undamaged; prior to powering on the device, the power cords and plugs should be inspected. Damaged
electrical parts must be replaced immediately by authorized personnel. Operating the machine with a
damaged power cord may cause an electric shock or re.
4. The use of accessories and cables other than those provided by the manufacturer may result in increased
emissions or decreased immunity of this device.
5. Gas cylinders:
• 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 protective cap of the cylinder, the cylinder valve should be inspected for damaged
threads, dirt, oil and/or grease. Any dust or dirt should be removed and the cylinder should not be
used if oil or grease is present.
• 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 and displayed on the
regulator.
• Close cylinder before disconnecting the cylinder from the device.
6. The device and reusable parts are NOT shipped and packaged cleaned. Applicable cleaning and disinfection
is required prior to rst use.
7. Residue and other contaminants in the breathing circuit pose a safety risk to the patient during testing
procedures. Aspiration of contaminants can be potentially life-threatening. The use of a disposable
antibacterial lter during CANOPY Mode and VENTILATOR Mode testing is mandatory to avoid
contamination of the device. For MASK Mode testing, each component which comes in contact with the
patient or the patient’s breath must be cleaned and disinfected prior to each test according to instructions
stated in the Cleaning and Disinfection Section of this manual.
8. This device is not intended for use in the presence of ammable anesthetics, it is not a AP (Flammable
anesthetic proof mixtures with air) or APG (Flammable anesthetic proof mixtures with oxygen or nitrous

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oxide) device (according to the IEC 60601-1 denition).
9. The device shall not be used near any heat source or ames, ammable or inammable liquids or gases
with 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. The device shall not be used in conjunction with any other medical device unless that device is
recommended by the manufacturer or shown in this user manual (e.g. ventilators inVENTILATOR Mode
settings).
13. When connecting to a computer:
• Make sure the computer has electromagnetic compatibility (EMC), CE marking or other Local
Certications and low radiation emission displays.
• Computer must be made compliant with IEC 60601-1 by means of an isolation transformer.
14. Precautions regarding EMC should be taken prior to device installation and can be found in the EMC section
of this manual.
15. Portable and mobile RF communication devices (including antenna cables and external antennas) should
be either powered o 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.
16. The device should not be placed adjacent to or stacked either on top or under another device. If this is
absolutely necessary, the device operation must be veried to ensure normal operation.
17. Do not place the device so that it can be dicult to disconnect it from the mains; the power cord connected
to the mains is intended to be the means of disconnection. Mains and the potential equalization node
must be always easily accessible.
18. Do not block or restrict the air inlet (cooling) on the instrument back panel.
19. Do not block or restrict the air outlet on the bottom part of the device.
20. Do not place the device in a conned space, always provide adequate ventilation around the device.
Clearance Area Cooling air ventilation scheme

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21. Do not place the device in any position that might cause it to fall on the patient.
22. This device shall be installed in an indoor environment on a at hard surface (do not place it on the oor) or
by means of an adequate standard VESA clamp; make sure that the surface is dry and clean from any dust.
23. As with all medical device, carefully route the ventilator circuit, patient cabling, and external power cables
to reduce the possibility of patient entanglement or strangulation.
24. Mechanical shocks or drops (e.g. as a result for a free fall or bang on hard surfaces) may have adverse
eects on measurements accuracy. Whether the device is visibly externally damaged or not, DO NOT use it
and immediately return it to COSMED or to an authorized service center for a technical service.
25. Any serious incident that occurs in relation to the device should be reported to the manufacturer and the
competent authority of the Member State in which user and/or patient is established.
26. Do not use Q-NRG/Q-NRG+ components for a cumulative period greater than 24 hours. Normal use of the
device is for a limited number of uses on the same patient over a limited timeframe, due to the limited
daily-weekly-monthly variation of resting energy expenditure (REE), as indicated in‘Best Practice Methods
to Apply to Measurement of Resting Metabolic Rate in Adults: A Systematic Review: J Am Diet Assoc. 2006;
106:881-903’. Typical maximum usage is for 60 minutes three or four times in two weeks.
Note: The device, program algorithms and data presentation have been developed in accordance with the
recommendations outlined in current scientic guidelines and literature, the bibliography of references
is reported in the Appendix.
This user manual has been developed in accordance with European Medical Device Directive and US 21 CFR 820
requirements.
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 patient vicinity and contains personal and sensitive patient data.
To ensure the patients’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 patients data are deleted after completing the
measurement.
• Procedural security measures - for example, assigning only sta with a specic role the right to use the
device.
In addition, any security concept must consider the requirements of local country laws and regulations.

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Always consider data security aspects of the network topology and conguration when connecting the device to
shared networks through OMNIA SW. Your medical facility is responsible for the security of the network, where
sensitive patient data from the device may be transferred.
When a device is returned for repair, disposed of, or removed from your medical facility for other reasons, always
ensure that all patient data is removed from the device.
Log les 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).
COSMED Product Security Policy Statement
Additional security and privacy information can be required to COSMED when sending an inquiry to support@
cosmed.com.
Manufacturer Disclosure Statement for Medical Device Security – MDS2
You can get a copy of the document (MDS2) for a specic product sending an inquiry to [e-mail].
Cyber Security Requirements and Controls
• Q-NRG cannot be connected directly to a Network.
• Q-NRG can be operated from a networked PC using the optional 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 rewalls 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, eectiveness, and data and system security.

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Software Updates Security
All software for Q-NRG metabolic monitors is completely designed and built by COSMED. There are no separate
user-updatable software components from other manufacturers.
COSMED authorized software updates for Q-NRG, 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 SW
updates is published on the COSMED web site, www.cosmed.com.
The installation procedure for software updates is described in the Instruction For Use of the specic product.
Battery (Safety, Storage and Transportation)
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 re. 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 aected 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 dierent 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.

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Oxygen Sensor (Safety, Storage and Transportation)
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:
• 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
ammable liquid stores.
• 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.
• 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.
• Transportation: O2 sensors are classied 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.

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Glossary of symbols
Device
Symbol Description Symbol Description
Applied part type BF
(IEC 60601-1, Table D.1, Symbol 20)
USB connector
CE mark (compliance with MDD 93/42) Read the user manual Warning
(IEC 60601-1, Table D.2, Symbol 10)
E509359
Medical - General medical equipment
as to electrical shock, re and mechanical
hazards only in accordance with ANSI/
AAMI ES60601-1: A1:2012, C1:2009/
(R)2012 and A2:2010/(R)2012, CSA CAN/
CSA-C22.2 NO. 60601-1:14
E509359
The device cannot be disposed as unsorted
municipal waste (see“Disposing of electrical
equipment”- Directive 2012/19/EU (WEEE))
Potential Equalization Node
(IEC 60601-1, Table D.1, Symbol 8)
Federal law restricts this device to sale by or on
the order of a licensed healthcare practitioner
– US market only
(21 CFR 801.109)
Indicates the manufacture’s catalogue
number so that the medical device can be
identied
(ISO 15223-1, Clause 5.1.6)
Warning
(IEC 60601-1, Table D.2, Symbol 2)
Indicates the manufacturer’s serial
number so that a specic medical device
can be identied
(ISO 15223-1, Clause 5.1.7)
This device has no alarm system
(IEC 60601-1-8, Table C.1, Symbol 3)
Non-ionizing electromagnetic radiation.
Equipment includes RF transmitters.
Interference may occur in the vicinity of
equipment marked with this symbol
(IEC 60417 – Symbol 5140)
Flow Pneumotach connectors
Canopy
Cal Flow
Canopy inlet / Flow-REE calibration Back panel screws
Turbine owmeter connector
(MASK Mode)
Serial port
Ethernet port (Technical purposes only) Direct Current
(IEC 60601-1, Table D.1, Symbol 4)
ON/OFF Button
(IEC 60601-1, Table D.1, Symbol 14)
USB port

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Ventilator Sampling line (“Ventilator”) port Technical failure indication (Led)
AC Power / Battery Status Indication (Led) Patient Sampling line (“Patient”) port
Intended population (age and weight) for
spontaneously breathing subjects when
using a mask; see“Indications for use”
Intended population (age and weight) for
ventilated subjects; see“Indications for use”
Intended population (weight) for sponta-
neously breathing subjects when using a
Canopy; see“Indications for use”
Packaging
Symbol Description Symbol Description
6
Maximum number of identical packages
which may be stacked on one another
(ISO 7000-2403)
Indicates a medical device that can be
broken or damaged if not handled carefully
(ISO 15223-1, Clause 5.3.1)
Indicates the correct upright position of
a package
(ISO 7000-0623)
Hooks are prohibited for handling the
package
(ISO 7000-0622)
Indicates the temperature limits to which
the medical device can be safely exposed
(ISO 15223-1, Clause 5.3.7)
Indicates a medical device that needs to be
protected from moisture
(ISO 15223-1, Clause 5.3.4)
Indicates a medical device that needs
protection from light sources
(ISO 15223-1, Clause 5.3.2)
95%
Indicates the range of humidity to which the
medical device can be safely exposed
(ISO 15223-1, Clause 5.3.8)
106kPa
60kPa
Indicates the range of atmospheric
pressure to which the medical device can
be safely exposed
(ISO 15223-1, Clause 5.3.9)
Federal law restricts this device to sale by
or on the order of a licensed healthcare
practitioner – only for US market
(21 CFR 801.109)
Indicates a medical device that is intend-
ed for one use
(ISO 15223-1, Clause 5.4.2)
Indicates a medical device that should not
be used if the package has been damaged
or opened
(ISO 15223-1, Clause 5.2.8)
Indicates the date after which the
medical device is not to be used
(ISO 15223-1, Clause 5.1.4)
Indicates the date when the medical device
was manufactured
(ISO 15223-1, Clause 5.1.3)