Q-NRG User Manual Edition 4.2 April 2020 PDF download

Q-NRG™+

User Manual

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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: firmware 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 and Transportation)��15 Oxygen Sensor (Safety, Storage and Transportation)��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 with VESA 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 2/148

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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 REF C04717-02-91 Q-NRG User Manual, Edition 4.2

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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 4/148

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Preventive Maintenance��95 Pneumatic Cartridge Replacement��98 Fan filter replacement��100 Mains fuses replacement��100 O2 sensor replacement��101 Firmware Update��104 Prepare the USB flash 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 Notifications��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 conflicting processes��117 Disable Power Management options��118 Wi-Fi Network Interference��118

Appendix119 CE Declaration of Conformity��120 EMC Conformity��121 IEC 62353 safety test��123 References��123 Test equipment and conditions��123 Commonly used definitions 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 REF C04717-02-91 Q-NRG User Manual, Edition 4.2

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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 specifications��140 Hardware specifications��140 Embedded software specifications��143 References��145 Bibliography��145 Cleaning and disinfection��145 Notes��146

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Chapter 1 - Get Started

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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 modifications 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 certification) Cleaning and Disinfection, Accessories, Hardware Specifications. General review.

April 2020

Manual purpose The Q-NRG 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 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 configuration 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 different 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. 8/148

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Q-NRG users includes Operators, Experts and Service personnel: User

Competences

Tasks

Operator

Scientific knowledge of procedures, practices, and terminology as required for performing test

Test execution (according to indications for use)

Expert

For installation, calibration and ordinary maintenance technical skills are recommended

Installation

Cleaning and disinfection is entrusted to subject matter experts with knowledge of related procedures and local/institute regulatory laws

Cleaning and disinfection

Technical background and awareness on hazards and risks associated with the performed procedures are required

Repair

Service personnel

Service personnel must be authorized by COSMED or COSMED affiliates

Calibration Ordinary maintenance (maintenance procedures addressed in the user manual) 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 configuration, 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 flammable 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 modification 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. 10/148

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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 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, 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 fire. 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 first 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 filter 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 flammable anesthetics, it is not a AP (Flammable anesthetic proof mixtures with air) or APG (Flammable anesthetic proof mixtures with oxygen or nitrous REF C04717-02-91 Q-NRG User Manual, Edition 4.2

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oxide) device (according to the IEC 60601-1 definition). 9. The device shall not be used near any heat source or flames, flammable or inflammable 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 in VENTILATOR Mode settings). 13. When connecting to a computer: • Make sure the computer has electromagnetic compatibility (EMC), CE marking or other Local Certifications 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 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. 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 verified to ensure normal operation. 17. Do not place the device so that it can be difficult 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 confined space, always provide adequate ventilation around the device.

Clearance Area

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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 flat hard surface (do not place it on the floor) 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 effects 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 scientific 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 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.

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Always consider data security aspects of the network topology and configuration 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 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).

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 specific product sending an inquiry to [email protected].

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 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.

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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 specific 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 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 shortcircuited 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. REF C04717-02-91 Q-NRG User Manual, Edition 4.2

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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 flammable 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 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.

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Glossary of symbols Device Symbol

E509359

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)

Medical - General medical equipment as to electrical shock, fire 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

The device cannot be disposed as unsorted municipal waste (see “Disposing of electrical equipment” - Directive 2012/19/EU (WEEE))

E509359 Potential Equalization Node

Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner – US market only (21 CFR 801.109)

(IEC 60601-1, Table D.1, Symbol 8)

Indicates the manufacture’s catalogue number so that the medical device can be identified (ISO 15223-1, Clause 5.1.6)

Warning

Indicates the manufacturer’s serial number so that a specific medical device can be identified

This device has no alarm system

(IEC 60601-1, Table D.2, Symbol 2)

(IEC 60601-1-8, Table C.1, Symbol 3)

(ISO 15223-1, Clause 5.1.7) Non-ionizing electromagnetic radiation. Equipment includes RF transmitters. Interference may occur in the vicinity of equipment marked with this symbol (IEC 60417 – Symbol 5140) Canopy

Flow

Pneumotach connectors

Canopy inlet / Flow-REE calibration

Back panel screws

Turbine flowmeter connector (MASK Mode)

Serial port

Ethernet port (Technical purposes only)

Direct Current

Cal Flow

(IEC 60601-1, Table D.1, Symbol 4) ON/OFF Button

USB port

(IEC 60601-1, Table D.1, Symbol 14)

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Ventilator

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Sampling line (“Ventilator”) port AC Power / Battery Status Indication (Led)

Technical failure indication (Led) Patient

Intended population (age and weight) for spontaneously breathing subjects when using a mask; see “Indications for use”

Sampling line (“Patient”) port

Intended population (age and weight) for ventilated subjects; see “Indications for use”

Intended population (weight) for spontaneously breathing subjects when using a Canopy; see “Indications for use”

Packaging Symbol 6

Description

106kPa

Description Indicates a medical device that can be broken or damaged if not handled carefully

Indicates the correct upright position of a package

Hooks are prohibited for handling the package

(ISO 7000-0623)

(ISO 7000-0622)

Indicates the temperature limits to which the medical device can be safely exposed

Indicates a medical device that needs to be protected from moisture

(ISO 15223-1, Clause 5.3.7)

(ISO 15223-1, Clause 5.3.4)

Indicates a medical device that needs protection from light sources

60kPa

Symbol

Maximum number of identical packages which may be stacked on one another (ISO 7000-2403)

(ISO 15223-1, Clause 5.3.1)

95%

Indicates the range of humidity to which the medical device can be safely exposed

(ISO 15223-1, Clause 5.3.2)

(ISO 15223-1, Clause 5.3.8)

Indicates the range of atmospheric pressure to which the medical device can be safely exposed

Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner – only for US market

(ISO 15223-1, Clause 5.3.9)

(21 CFR 801.109)

Indicates a medical device that is intended for one use

Indicates a medical device that should not be used if the package has been damaged or opened

(ISO 15223-1, Clause 5.4.2)

(ISO 15223-1, Clause 5.2.8)

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Indicates the date after which the medical device is not to be used

Indicates the date when the medical device was manufactured

(ISO 15223-1, Clause 5.1.4)

(ISO 15223-1, Clause 5.1.3)

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Indicates the Authorized representative in the European Community

Indicates the need for the user to consult the instructions for use

(ISO 15223-1, Clause 5.1.2)

(ISO 15223-1, Clause 5.4.3)

Indicates the medical device manufacturer

UDI data matrix

(ISO 15223-1, Clause 5.1.1) Do not open the package using a sharp tool

O2 sensor Symbol

Description

Symbol

Harmful (Symbol GHS-07)

Description Indicates the temperature limits to which the medical device can be safely exposed (ISO 15223-1, Clause 5.3.7)

Read the user manual (IEC 60601-1, Table D.2, Symbol 10)

Pneumatic Cartridge Symbol

Description

Symbol

Harmful

Description Warning (IEC 60601-1, Table D.2, Symbol 2)

(Symbol GHS-07)

Battery Symbol

Description

Symbol

Description

Dispose of this product according to local regulations

Recycling Symbol Taiwan

Recycling Symbol

China RoHS

For Canada & USA: Please call

Mark of conformity to applicable European Directives

1-800-822-8837 for information on how to recycle this battery UN Transportation Test

REF C04717-02-91 Q-NRG User Manual, Edition 4.2

Regulatory Compliance Mark of Japan

19/148

COSMED srl

Hemodynamic and Metabolic Monitors

Q-NRG User Manual Edition 4.2 April 2020