Q-NRG Service Manual Edition 3 July 2021

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Functional check acceptable ranges review

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Miscellaneous clarifications throughout document. Includes: July 2021 Spelling, grammar, references, hyperlinks, figure numbers, etc. Add information applicable to 1.3 software updates. Update Device Evaluation and Release Testing calibration/ test instructions Update Repair instructions Add checklist as an appendix to the Service Manual

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Q-NRG Service manual, Edition 3 (07/2021)

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Issued Date:25-Aug-2021 Effective Date:24-Sep-2021

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Table of Contents ... 3 Get Started ... 9 Manual Information ... 10  Service Manual’s publishing details and revision history ... 10  Manual purpose ... 10  Intended audience ... 10  Related documents ... 11 Important Notices ... 12  Introduction to indirect calorimetry ... 12  Indications for use ... 12 Safety information... 13  Precautions... 13  Security Information ... 15  COSMED Product Security Policy Statement ... 16  Cyber Security Requirements and Controls... 16  Security Software Updates ... 17  Battery Safety, Storage and Transportation ... 17  O2 Sensor Safety, Storage and Transportation ... 18  Explanation of symbols marked on the product / accessories... 18 Service information ... 22  Service requirements ... 22  Device identification ... 22 Unpacking ... 23 System Overview ... 24 Q-NRG Device ... 25 Optional Calibration Syringe ... 26 Optional Calibration Cylinder and Pressure Regulator ... 26 Installation ... 27 Preliminary Operations... 28  Perform “Electrical safety test”... 28  Potential Equalization Node ... 28  Charge Q-NRG ... 28  Power ON and OFF ... 28 To Power ON the Device... 28 To Power OFF the Device... 29  Calibrate Q-NRG ... 29

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Table of Contents

Issued Date:25-Aug-2021 Effective Date:24-Sep-2021  Perform “Functional check” ... 29 Software Installation ... 30  OMNIA Computer Software ... 30 Minimum System Requirement... 30  USB Driver... 30  Authorization... 30  Bluetooth® Pairing ... 31 Introduction ... 31 Requirements ... 31 Note ... 31 Procedure ... 31 Q-NRG Operation ... 33 User System Interface ... 34  Display functions – Home Page ... 34  Entering Numbers / Date / Text ... 35  Device Information... 36 Operating through Control Panel ... 37 Calibration ... 39  Preface ... 39  Device Warm-Up... 39  Required Calibration Procedures ... 39  Calibration menu ... 40  Pneumotach calibration (Ventilator Mode) ... 40  Gas Analyzers (Cylinder)... 40  Gas Analyzers (Room Air) ... 40  Turbine calibration (Face Mask) ... 40  Blower calibration (Canopy mode) ... 40  Calibration Results and References ... 41 Pneumotach (Ventilator Mode) ... 41 Turbine (Face Mask Mode) ... 41 Blower (Canopy Mode) ... 41 Gas Analyzers (all test modes) ... 41 References ... 42 Controlling the Q-NRG from Omnia software... 43 Theory of operation ... 44  Canopy mode measurement ... 44  Ventilator mode measurement ... 44  Face mask mode measurement ... 45  Block diagram ... 45  Electro-pneumatic circuit ... 46 Q-NRG Service manual, Edition 3 (07/2021)

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OMNIA installation... 30

Issued Date:25-Aug-2021 Effective Date:24-Sep-2021 Main components ... 47  Digital board... 48 Adjustments ... 48  Power Board ... 49  Analog Board... 51 Adjustments ... 51  Interface Board ... 52  LED board ... 52  Ambient temperature and RH board ... 52  Pneumatic manifold... 53  O2 sensor ... 53  CO2 sensor ... 54  Pneumatic cartridge... 54  Canopy Blower ... 55  ID18 internal turbine flowmeter ... 55 System Maintenance ... 57 Overview ... 58  Recommended Maintenance Schedule ... 58 Cleaning and Disinfection ... 59 Preventative Maintenance... 60 Upgrade Firmware... 61  Prepare the USB flash drive device ... 61  Firmware Update ... 61  Perform Calibrations ... 63 Update Q-NRG licenses ... 65 Troubleshooting ... 66 Miscellaneous problems ... 67 Error messages and Notifications ... 69 Export Error Log ... 69 List of Error Messages ... 70 1 – Error codes ... 71 List of Failure Modes ... 82 2 - Safety ... 83 3 - Q-NRG+ Basic Functioning ... 85  87 4 - Unreliable measurements ... 88 List of Notifications ... 88 Errors Opening / Starting Omnia software ... 89 Q-NRG Service manual, Edition 3 (07/2021)

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 Display Assembly ... 50

Issued Date:25-Aug-2021 Effective Date:24-Sep-2021 Service procedures ... 95 Service / Troubleshooting Workflow ... 96 Required tools ... 97 Disassembling Q-NRG ... 99  Disassembling guidelines ... 99 Open back panel... 101 Adjusting sampling flow rate ... 103 Adjusting gas calibration flow rate ... 104 Replacing the mains fuses... 105 Replacing battery pack ... 106  Procedure ... 106 O2 sensor replacement ... 107 Replacing the pneumatic cartridge ... 109 Open back housing to access Q-NRG ... 111 Replacing cooling fan and filter ... 112 Power Entry Module Assembly ... 113 Potential Equalization Node ... 114 Replacing Gas Calibration Fitting ... 115 Replacing Analog Sampling Fitting ... 116 Replacing Ambient Temperature/RH probe ... 117 Replacing ANALOG board ... 118 Replacing CO2 sensor... 120 Replacing sampling pump ... 121 Replacing Manifold ... 122 Replacing Analog Syringe ... 123 Replacing LED board ... 124 Replacing POWER board ... 125 Replacing DIGITAL board ... 127  Complete Q-NRG serialization ... 127 Replacing DISPLAY and/or front frame ... 128 Replacing front Luer lock receptacles... 130 Replacing external turbine flowmeter receptacle ... 131 Replacing Canopy BLOWER... 132 Replacing INTERFACE board ... 133 Replacing ID18 internal flowmeter ... 134 Functional check ... 135  Necessary tools ... 135 Device Evaluation ... 138 Release Testing... 151 IEC 62353 safety test ... 172  References ... 172 Q-NRG Service manual, Edition 3 (07/2021)

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 ESD precautions ... 99

Issued Date:25-Aug-2021 Effective Date:24-Sep-2021  Test equipment and conditions ... 172  Commonly used definitions within IEC 62353 (and IEC 60601) ... 172  Visual inspection ... 173  Protective Earth resistance ... 173  Performing Electrical Safety Test ... 176 Fixing Bluetooth issues ... 178  Check for pending Windows software updates ... 178  If a BTA is used, be sure that internal Bluetooth module is disabled ... 178  Replace “CSR Bluetooth Chip” drivers with “Generic Bluetooth” drivers ... 178  Check if Bluetooth drivers are correctly installed ... 179 Check installed Bluetooth drivers ... 179 Reinstall Drivers ... 179  Remove Q-NRG “hidden” devices from PC configuration, if present ... 179  Use a different USB port ... 180  Check for incompatible or conflicting processes ... 180 End interfering background processes:... 181 End interfering services: ... 181  Disable Power Management options ... 181  Turn off disturbing Wi-Fi networks ... 181 Service parts... 182 Appendix ... 187 Service Forms ... 188  Check-in/out form ... 188 CE Declaration of conformity ... 190 EMC Conformity... 191 Emission limits ... 191 Enclosure port immunity... 191 Enclosure port immunity to RF wireless communications equipment ... 192 Input AC power port immunity ... 192 Patient coupling port immunity ... 193 Warranty and service policy ... 194  Warranty and limitation of liability ... 194  Return goods policy for warranty or non-warranty repair... 194 Mean time to repair ... 195 Other information ... 196  Contraindications for Indirect Calorimetry testing ... 196  Environmental condition of use ... 196  Manufacturer’s information ... 196 Complaints, feedback and suggestions ... 196  Privacy Information ... 196 Q-NRG Service manual, Edition 3 (07/2021)

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 Equipment leakage current ... 174

Issued Date:25-Aug-2021 Effective Date:24-Sep-2021  Disposing of electrical equipment ... 196 Accessories/Spare parts ... 197  Device Versions ... 197  Optional accessories ... 197  Maintenance parts... 200 Safety and conformity ... 202 Safety ... 202 EMC ... 202 Telemetry (EU)... 202 Quality Assurance ... 202 Medical Device Directive (CE mark) ... 202 Applied parts ... 202 FCC/IC ... 202 Technical specifications ... 204 Hardware specifications ... 204 Power Supply (mains)... 204 Power Supply (rechargeable battery)... 204 Pneumotach Flowmeter (Ventilator mode) ... 204 Internal Turbine Flowmeter (Canopy Mode / Flow-REE Calibration) ... 204 External Turbine Flowmeter (Face Mask mode) ... 204 Oxygen Sensor (O2) ... 205 Carbon Dioxide Sensor (CO2) ... 205 Measured parameters range and accuracy... 205 Environmental Sensors ... 205 Wireless Connectivity ... 205 Wired Connectivity ... 205 Miscellaneous... 205 Embedded software ... 206  Device Evaluation Checklist ... 207  Release Testing Checklist... 212  Electrical Safety Testing... 217

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 Disposables ... 200

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Get Started

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Manual Information

The present Q-NRG Service Manual provides information to service procedures related to the medical devices named Q-NRG (REF C09092-01-99) and Q-NRG+ (REF C09092-02-99) hereinafter respectively Q-NRG, Q-NRG+ or device. This Service 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 Service Manual; if in doubt, contact COSMED support. Nothing in this Service 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. Whenever the Service Manual is updated, revision changes. Edition

Comment

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Initial release

January 2019

1

Chapters updates

September 2019

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Chapters updates

March 2020

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Chapters updates

July 2021

 Manual purpose This service manual supplies technical information for service representatives and technical personnel, so they can install and maintain the device to the assembly level. Use it as a guide for installation, maintenance and repairs considered field repairable. Where necessary the manual identifies additional sources of relevant information and technical assistance.

 Intended audience This 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. 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 Calibration

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

Ordinary maintenance (maintenance procedures addressed in the User Manual)

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Cleaning and disinfection

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 Service Manual’s publishing details and revision history

Issued Date:25-Aug-2021 Effective Date:24-Sep-2021 Technical background and awareness on Repair hazards and risks associated with the performed Complex maintenance (maintenance procedures procedures are required addressed in the Service Manual) Service personnel must be authorized by COSMED or COSMED affiliates

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 User’s manual (REF C04717-02-91)  Q-NRG cart instructions for installation, use and cleaning (REF DU-COS-0001-60)  Q-NRG clamp instructions for installation, use and cleaning (REF C04824-01-91)  OMNIA SW manual (REF C04144-02-91) Note: Pictures shown in this manual may not exactly match your device or accessories aspect.

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Service personnel

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Important Notices

Indirect calorimetry is a method to determine the energy expenditure by measuring oxygen consumption (VO2) and carbon dioxide production (VCO2) of a patient. These measurements allow the Resting Energy Expenditure (REE) and the Respiratory Quotient (RQ) to be calculated. The RQ represents the ratio of carbon dioxide exhaled to the amount of oxygen consumed by the individual. RQ assists in the interpretation of the REE results. Resting energy expenditure (REE), or energy expenditure measured in resting conditions either on spontaneously breathing or mechanically ventilated patients has a number of useful clinical applications; references are cited in the Appendix of this manual. The REE measurement acts as a precise tool in determining a subject’s basal nutritional requirements., it provides information that allows for adequate planning of nutritional goals. The Resting Energy Expenditure is the minimum caloric requirement of the organism in order to sustain life. This includes calories for the vital organs to properly operate at rest (heart, brain, lungs, liver, kidneys, etc.). Caution: Federal law restricts this device to sale by or on the order of a licenced healthcare practitioner.

 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 CAUTION: For United States ONLY. Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner

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 Introduction to indirect calorimetry

Issued Date:25-Aug-2021 Effective Date:24-Sep-2021

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. This device measures clinical parameters used to aid diagnosis and it is intended only as an adjunct device in patient assessment. In case of disturbing conditions, the shutdown is allowed because the safety of the device towards patients and operators is not affected, since the final evaluation is performed on the outcome data measured during a complete test. It must be used in conjunction with other methods of assessing clinical signs and symptoms. COSMED is not responsible for incidents which occur due to improper use of this device. Examples include, but are not limited to: 

- operation of the device by unqualified personnel

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- use of the device in a way which is not indicated by this manual

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- 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 mains with protective earth. No modification of this device is allowed. 

Due to the required level of technical and patient assessment skills, measurement using Q-NRG should be performed by individuals trained in and with demonstrated and documented ability to:

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- calibrate

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- operate and maintain the device

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- operate a mechanical ventilator (including knowledge of alarm and monitoring function)

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- recognize metabolic measurement values within the physiological range and,

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- evaluate the results in light of the patient’s nutritional and clinical status.

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 Service Manual has been developed in accordance with European Medical Device Directive requirements and 21 CFR 820.

 Precautions Note the following precautions before operating the device to ensure the safety of the user and patient: 1. This Service Manual should always be available as a reference while maintaining the device 2. The following standards should be applied to ensure the accuracy of individual test results: a)

Accessories (including disposables) must only be used as they are described in this manual. COSMED does not warranty the use of any un-authorized accessories by the end user. COSMED may offer suggestions while using such accessories and the complications they could cause.

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Safety information

Issued Date:25-Aug-2021 Effective Date:24-Sep-2021 b) Repairs or modifications of the device should ONLY be performed by authorized personnel. c)

Environmental and electrical conditions in which the device operates should be in compliance with the specifications of this manual.

d) Device maintenance, inspections, disinfection and cleaning should be conducted as described in

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 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: a) 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 b) 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 c) Ensure that the pressure regulator is compatible with the intended gas cylinder (chemically and physically) prior to installation d) The regulator must be properly connected and working pressure adjusted and displayed on the regulator e) Close cylinder before disconnecting the cylinder from the device 6. The device and reusable parts are NOT shipped and packaged pre-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 anti-bacterial filter during Canopy and ventilator testing is mandatory. For Face 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 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 service manual (e.g. ventilators in ventilator mode settings) 13. When connecting to a computer: a) Make sure the computer has electromagnetic compatibility (EMC), CE marking or other Local Certifications and low radiation emission displays b) 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 noted 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 Q-NRG Service manual, Edition 3 (07/2021)

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this manual.

Issued Date:25-Aug-2021 Effective Date:24-Sep-2021

17. 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 18. 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 19. Do not block or restrict the air inlet (cooling) on the instrument back panel 20. Do not block or restrict the air outlet on the bottom part of the device. 21. Do not place the device in a confined space, always provide adequate ventilation around the device.

Clearance Area

Cooling air ventilation scheme

22. Do not place the device in any position that might cause it to fall on the patient 23. 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. 24. 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. 25. If the product is damaged (e.g. as a result for a free fall), the device effectiveness and safety can be altered. Please DO NOT use it and immediately return it to COSMED or to an authorized service center for a technical service

 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.

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(including cable) to eliminate potential electrical interferences and the degradation of the device’s performance. 16. Only cables and accessories supplied with this device should be used with this device. Any accessories or cables, other than those supplied may result in increased emissions or decreased immunity of the device or increased hazards.

Issued Date:25-Aug-2021 Effective Date:24-Sep-2021 As per its intended use, the device operates in the patient vicinity and contains personal and sensitive patient data.

 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. 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 Directive on the protection of individuals with regard to the processing of personal data and on the free movement of such data (Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995). In addition, your facility should also take into account any additional, more stringent standards put forward by any individual EU countries.

 COSMED Product Security Policy Statement Additional security and privacy information can be required to COSMED when sending an enquiry to support@ cosmed.com. Manufacturer Disclosure Statement for Medical Device Security – MDS2 You can get a copy of the Manufacturer Disclosure Statements for Medical Device Security (MDS2) for a specific product sending an enquiry to [email protected].

 Cyber Security Requirements and Controls •

Q-NRG cannot be connected directly to a Network.

•

Q-NRG can optionally be operated from a networked PC through the dedicated Omnia SW.

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To ensure the patients’safety and protect their personal health information you need a security concept that includes:

Issued Date:25-Aug-2021 Effective Date:24-Sep-2021 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. Only connect COSMED devices, operated from Omnia SW to networks that are explicitly intended for that purpose. If you connect the monitor to a network, it is therefore highly recommended that you deploy measures for protecting 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.

 Security Software Updates All software for Q-NRG metabolic monitors is completely built and integrated 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 component of the COSMED Quality System. Availability of SW updates is published and available on COSMED web site, www.cosmed.com

 Battery Safety, Storage and Transportation 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 within 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. Use only 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. 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 Q-NRG Service manual, Edition 3 (07/2021)

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Network Cyber Security Measures

Issued Date:25-Aug-2021 Effective Date:24-Sep-2021

The Li-Ion rechargeable battery incorporated 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.

 O2 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.

 Explanation of symbols marked on the product / accessories The graphical symbols used with the device are described below: Applied part type BF

USB connector

(IEC 60601-1, Table D.1, Symbol 20)

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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. In view of this fact, IATA has produced a guide to help Shippers understand and comply with the regulations (http://www.iata.org/ ).

Issued Date:25-Aug-2021 Effective Date:24-Sep-2021 CE mark (compliance with MDD 93/42)

Read the user and service manual Warning

Potential Equalization Node

REF

SN

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

The device cannot be disposed as unsorted municipal waste (see Appendix/Other information Directive 2012/19/EU (WEEE))

Indicates the manufacture’s catalogue number so that the medical device can be identified

Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner

(ISO 15223-1, Clause 5.1.6)

(21 CFR 801.109)

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

Warning

Release Status:Issued and Effective

(IEC 60601-1, Table D.2, Symbol 10)

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

(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.

This device has no alarm system (IEC 60601-1-8, Table C.1, Symbol 3)

(IEC 60417 – Symbol 5140) Canopy Cal Flow

Ventilator

Canopy inlet / Flow-REE calibration

Flow

Pneumotach connectors

Turbine Flowmeter connector (Face Mask mode)

Back panel screws

Ethernet port (Technical purposes only)

Serial port

ON/OFF Button

Direct Current

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

(IEC 60601-1, Table D.1, Symbol 4)

Sampling line (ventilator) port

USB port

AC Power / Battery Status Indication (Led)

Technical failure indication (Led)

Intended population (age and weight) Patient for spontaneously breathing subjects when using a face mask; see indications for use

Sampling line (patient) port

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

Intended population (age and weight) for ventilated subjects; see indications for use

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Issued Date:25-Aug-2021 Effective Date:24-Sep-2021

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/CSAC22.2 NO. 60601-1:14 <E509359> The graphical symbols used on the package of the device and accessories are described below: Maximum number of identical packages which may be stacked on one another (ISO 7000-2403)

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

Indicates the correct upright position of a package (ISO 7000-0623)

Indicates a medical device that can be broken or damaged if not handled carefully (ISO 15223-1, Clause 5.3.1)

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

Hooks are prohibited for handling the package (ISO 7000-0622)

(ISO 15223-1, Clause 5.3.7) Indicates a medical device that needs protection from light sources

Indicates a medical device that needs to be protected from moisture

(ISO 15223-1, Clause 5.3.2)

(ISO 15223-1, Clause 5.3.4)

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

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

(ISO 15223-1, Clause 5.3.9)

(ISO 15223-1, Clause 5.3.8)

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) 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)

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)

Q-NRG Service manual, Edition 3 (07/2021)

20

Release Status:Issued and Effective

MEDICAL - GENERAL MEDICAL EQUIPMENT