Page 1 Q-NRG ™ User Manual...
Page 3 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.
Page 4: Table Of Contents
Chapter 2 - Installation 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 REF C04717-02-91 Q-NRG User Manual, Edition 4.2...
Page 5 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 3/148...
Page 6 Execute a test from OMNIA ........................83 Chapter 5 - Maintenance 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 REF C04717-02-91 Q-NRG User Manual, Edition 4.2...
Page 7 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 5/148...
Page 8 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 6/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2...
Page 9: Chapter 1 - Get Started
COSMED srl Chapter 1 - Get Started Chapter 1 - Get Started REF C04717-02-91 Q-NRG User Manual, Edition 4.2 7/148...
Page 10: Manual Information
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.
Page 11: Related Documents
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.
Page 12: Important Notices
• 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: •...
Page 13: Precautions
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.
Page 14 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 Cooling air ventilation scheme 12/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2...
Page 15: Security Information
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...
Page 16: Cosmed Product Security Policy Statement
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 support@cosmed.com. Cyber Security Requirements and Controls • Q-NRG cannot be connected directly to a Network.
Page 17: Software Updates Security
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.
Page 18: Oxygen Sensor (Safety, Storage And Transportation)
• 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. 16/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2...
Page 19: Glossary Of Symbols
Cal Flow Turbine flowmeter connector Serial port (MASK Mode) Ethernet port (Technical purposes only) Direct Current (IEC 60601-1, Table D.1, Symbol 4) ON/OFF Button USB port (IEC 60601-1, Table D.1, Symbol 14) REF C04717-02-91 Q-NRG User Manual, Edition 4.2 17/148...
Page 20 (ISO 15223-1, Clause 5.2.8) Indicates the date after which the Indicates the date when the medical device medical device is not to be used was manufactured (ISO 15223-1, Clause 5.1.4) (ISO 15223-1, Clause 5.1.3) 18/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2...
Page 21 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 Regulatory Compliance Mark of Japan REF C04717-02-91 Q-NRG User Manual, Edition 4.2 19/148...
Page 22 Chapter 1 - Get Started COSMED srl Gost Regulatory Compliance Mark of Australia UL Recognized for Canadian and US market and New Zealand China CQC India BIS 20/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2...
Page 23: Introduction To Indirect Calorimetry
REE 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.). REF C04717-02-91 Q-NRG User Manual, Edition 4.2 21/148...
Page 24: Device Overview
Chapter 1 - Get Started COSMED srl Device Overview Q-NRG is a portable Metabolic Monitor, designed for the measurement of resting energy expenditure (REE) in both spontaneously breathing and ventilated subjects; there are two versions of the device, described below: Q-NRG...
Page 25: Measurement Modes
COSMED srl Chapter 1 - Get Started Measurement Modes Q-NRG models can measure REE (Resting Energy Expenditure) using three modes: • VENTILATOR (ventilated subjects). • CANOPY (spontaneously breathing subjects). • MASK (spontaneously breathing subjects). VENTILATOR A single use flowmeter (Flow-REE), placed in series in the patient circuit, allows the in-line measurement of ventilatory parameters (Vt, RF, and VE).
Page 26: Mask
A reusable face mask (available in 5 different sizes) attached to the external turbine flowmeter allows for the measurement of VO2 and VCO2 in spontaneously breathing subjects who are not comfortable with a hood over their head. 24/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2...
Page 27: Q-Nrg Device Diagram
Potential Equalization Node Single use Pneumotach pressure line (-) Canopy outlet Canopy inlet / Flow-REE calibration Device label Ventilation grid / Room air inlet 2 x USB type A (storage device or accessories) REF C04717-02-91 Q-NRG User Manual, Edition 4.2 25/148...
Page 28: Main Components
Chapter 1 - Get Started COSMED srl Main Components Q-NRG consists of the main parts described below: Component Q-NRG Q-NRG+ Main Unit Standard Standard VENTILATOR Mode Items Not Available Standard CANOPY Mode Kit Standard Option MASK Mode Kit Option Option...
Page 29: Mask Mode Kit
(small/medium size), sampling lines are sold separately. See also “Accessories/Spare Parts” . Head cap Turbine flowmeter w/ Luer adapter (18mm) REFA-800-900-022 Large REF C04770-01-04 REF A-800-900-023 Small/Medium Reusable face mask Sampling line REF A-180-100-002 REF C0361(X)-01-10 Different sizes available Mask adapter REF C02839-01-20 REF C04717-02-91 Q-NRG User Manual, Edition 4.2 27/148...
Page 30: 3L Calibration Syringe
Pole/Rail Clamp with VESA Mounting Plate This optional clamp (REF C04756-01-10) allows the Q-NRG to be secured to either poles (19 to 38mm OD, 0.75”-1.5”) or rails (10x25mm). The same clamp is necessary when installing Q-NRG onto the optional cart (see “Cart”).
Page 31: Cart
• Storage of data and results in a secure database (network server or standalone computer). • Remote test execution via USB or Bluetooth®. • Advanced data analysis, data export. • Customizable reports. • Integration with Hospital Information Systems (HL7 or GDT). REF C04717-02-91 Q-NRG User Manual, Edition 4.2 29/148...
Page 32 COSMED srl 30/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2...
Page 33: Chapter 2 - Installation
COSMED srl Chapter 2 - Installation Chapter 2 - Installation REF C04717-02-91 Q-NRG User Manual, Edition 4.2 31/148...
Page 34: Preliminary Operations
Connect the device to the power source using the power cable included in the package. The charging status is indicated by the LEDs on the top of the Q-NRG device (charging time 32/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2...
Page 35: Power On And Off
Q-NRG device is connected to external power and the battery is completely charged Power ON and OFF Q-NRG can operate either when powered by external AC power or by the internal battery, which is recharged whenever the device is connected to power.
Page 36: Calibration Cylinder Set-Up
Calibration Cylinder Set-up Q-NRG requires a monthly calibration of both Oxygen and Carbon Dioxide sensors using a reference gas. COSMED provides a 3.7L pressurized Gas Cylinder with a known and certified gas mixture (16% O2, 5% CO2 and N2 balance).
Page 37 6 bar (70-90 psi). 7. Open the ON/OFF Valve – turn it to horizontal position parallel to the output line. WARNING: Make sure to close the ON/OFF Valve before disconnecting the hoses from Q-NRG REF C04717-02-91 Q-NRG User Manual, Edition 4.2 35/148...
Page 38: Software Installation
Software Installation Q-NRG can be provided with an optional PC software (OMNIA). Q-NRG can communicate with OMNIA via Bluetooth® or via USB. Using Q-NRG in conjunction with OMNIA users can: • Perform tests (remote control) • Download patient data and tests.
Page 39: Usb Driver
COSMED srl Chapter 2 - Installation USB Driver As soon as OMNIA has successfully been installed, power on Q-NRG and connect it to a computer via the USB cable, USB drivers will be automatically installed by Windows. Authorization Before proceeding with SW authorization, be sure that valid license is stored into device. For for further details refer to ”Update Q-NRG licenses”.
Page 40 COSMED srl 38/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2...
Page 41: Chapter 3 - Q-Nrg Operation
COSMED srl Chapter 3 - Q-NRG Operation Chapter 3 - Q-NRG Operation REF C04717-02-91 Q-NRG User Manual, Edition 4.2 39/148...
Page 42: User Interface
COSMED srl User Interface Q-NRG can be operated using the LCD touch screen. The capacitive color display allows the user to interact with the touch screen while wearing surgical gloves. Do not operate the touch screen area with sharp objects.
Page 43 Reset the device to Factory Default Settings (all data will be erased!) Factory Settings Refuse message on dialog box Confirm message on dialog box Add New Patient in the Archive Return to “Home” page Information about the device REF C04717-02-91 Q-NRG User Manual, Edition 4.2 41/148...
Page 44: Keyboard
To enter text, numbers and dates, use the contextual virtual keyboards that appear. Device Info Press the button ( ) to access general information about the System, Hardware, Firmware and Open info Source License. 42/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2...
Page 45: Settings
Advanced Field Description Rec Automatically After (min) Define the time after which the Q-NRG begins storing test data automatically (default=2min) Discard Non-Physiological Values Enable/Disable the algorithm which discards breaths outside of physiological range REF C04717-02-91 Q-NRG User Manual, Edition 4.2...
Page 46: Printout
[Owen O.E., Kavle E., Owen R.S., Polansky M., Caprio S., Mozzoli M.A., Kendrick Z.V., Bushman M.C., Boden G.: A reappraisal of caloric requirements in healthy women. Am. J. Clin. Nutr., 44, 1–19, 1986] 44/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2...
Page 47: Maintenance
Allow the user to manually set date of the last pneumatic cartridge installation Pneumatic Cartridge LOT Specify pneumatic cartridge LOT# O2 Sensor Installation Date Allow the user to manually set date of last O2 sensor installation O2 Sensor S/N Specify O2 sensor S/N REF C04717-02-91 Q-NRG User Manual, Edition 4.2 45/148...
Page 48: Utility
Q-NRG is compatible with “FAT32” formatted USB flash drives ONLY (32 GB Max storage size). To Export a Database to a USB flash drive 1. Insert the USB flash drive into an available USB Port on the left side of Q-NRG. 2. Select...
Page 49: Control Panel
Sample gas from “Patient” inlet with a flow rate that is proportional to flow (MASK Mode) Ventilator Leak This configuration allows to exclude pneumatic leaks according to a specific procedure to be performed by authorized service centers only REF C04717-02-91 Q-NRG User Manual, Edition 4.2 47/148...
Page 50 Set O2 hardware span Realtime signals O2 (%), CO2 (%), Analyz_press (mmHg), Blower Vp (L/min), PNT Vol. (mL), PNT Flow (mL/s), TURB Vol. (mL), TURB Flow (mL/s), PB (mmHg), T_amb (°C), T_device (°C), Humidity (%) 48/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2...
Page 51: Calibration
Chapter 3 - Q-NRG Operation Calibration Q-NRG has been designed for resting metabolic rate measurement without the need of time-consuming warm- up and daily calibrations; To achieve this, Q-NRG adopts more complex technological solutions compared to conventional metabolic systems, e.g. most calibration procedures are automatically and seamlessly performed in the background by the device prior to or during measurements and all parameters are adjusted to the testing environmental conditions.
Page 52: Calibration Menu
Canopy blower, monitored by a pre-calibrated internal turbine flowmeter, to generate a known amount of inhalation flow that will be compared with the one measured by the single use pneumotach to calculate the ideal correction factor. 50/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2...
Page 53: Gas Analyzers (Cylinder)
1. Unpack a new Flow-REE (single use) pneumotach. 2. Connect the tubes to the front panel of the Q-NRG unit matching the connectors colour (blue tube to blue connector, clear tube to white connector) as shown in the image below.
Page 54: Gas Analyzers (Room Air)
2. Start the calibration procedure following the on-screen instructions. Calibration is automatic and does not require any interaction. Blower/Internal Flowmeter – (CANOPY Mode) The Q-NRG has an internal turbine flowmeter (blower) which is used both for calibrating the single use flowmeter (pneumotach) and measuring the dilution flow during CANOPY Mode testing. 52/148...
Page 55: Turbine/External Flowmeter - (Mask Mode)
2. Connect the turbine to the calibration syringe using the turbine calibration adapter as shown in the image below. 3. Start the calibration procedure following the instructions prompted on the screen. 4. Perform the required number of strokes paying attention to cover the whole motion range of the syringe. REF C04717-02-91 Q-NRG User Manual, Edition 4.2 53/148...
Page 56: Calibration Results And References Values
Pneumotach gain Blower (CANOPY Mode) Cal. Factor Acceptable Range Default Note Last (mm/dd/yyyy, hh/ Date and time of last calibration Result PASS/FAIL Are all factors within range? Gain (----) 900-1100 1000 Flowmeter span 54/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2...
Page 57 References Settings Admissible Range Default O2 Reference (%) 12.00 – 20.50 16.00 CO2 Reference (%) 0.50 – 6.00 5.00 Syringe (mL) 500 - 3000 3000 Pneumotach Cal. Flow (mL/s) 200 - 400 REF C04717-02-91 Q-NRG User Manual, Edition 4.2 55/148...
Page 58: Test Overview
Operating by AC Power or Battery Q-NRG can be powered by the rechargeable battery or plugged into the wall outlet. Prior to starting a measurement using battery power, make sure that the residual capacity displayed on the LCD is enough to start a test (at least 15% for a test lasting 10 minutes, depending also on the battery’s age).
Page 59: Selecting Or Entering Patient Data
1. Power on the device by pressing and holding the ON/OFF button for two seconds. 2. Wait for a 5 minute warm up before starting the measurements. Selecting or Entering Patient Data Before starting a test, the Q-NRG requires a patient to be selected (new patient entered or one selected from database) Note: Some patient details (Last Name, First Name, Height and Weight) are mandatory to start the measurement.
Page 60: Test Results
The following table summarizes the disposable items and the ones requiring cleaning procedures for each measurement mode. Test Mode Disposables Reusable(cleaning required) Device surfaces VENTILATOR Flow-REE REF A-662-250-003 Sampling line (x2) REF A-180-100-002 HME Antibacterial Filter REF A-182-300-006 Antibacterial Filter REF A-182-300-007 FiO2 adapter REF A-820-173-002 58/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2...
Page 61 Antibacterial filter Canopy hood REF A-182-300-004 REF C03880-0X-10 Canopy veil Canopy hose REF C04690-0X-10 REF C02678-01-07 MASK Sampling line Mask REF A-180-100-002 REF C0361X-01-10 Head cap REF A-800-900-02X Turbine flowmeter REF C04770-01-04 REF C04717-02-91 Q-NRG User Manual, Edition 4.2 59/148...
Page 62: Glossary Of Parameters
Chapter 3 - Q-NRG Operation COSMED srl Glossary of Parameters The following parameters are measured/calculated by Q-NRG Parameter Description Available in Mode VO2 (mL/min) Oxygen consumption VCO2 (mL/min) Carbon dioxide production RQ (---) Respiratory quotient EE (Kcal/day) Energy expenditure VT (L)
Page 63 Chapter 3 - Q-NRG Operation Step has been identified as an artifact FiO2 reading performed during current step Automatic zeroing of PNT pressure sensor performed during current step Unable to complete the automatic calibration REF C04717-02-91 Q-NRG User Manual, Edition 4.2 61/148...
Page 64: Recommendations During Testing
• Position the Q-NRG correctly to avoid reading of possibly contaminated air. Q-NRG Placement The Q-NRG has an air intake on the back of the device for air cooling and automatic calibration purpose; the following recommendations are common among all test modalities. When installing, make sure there is adequate clearance area of air intake to ensure optimal performance of the unit;...
Page 65: Canopy Mode
• Blower flow rate within the selected averaging interval shall be constant. MASK Mode • VO2 and VCO2 accuracy relies on the measurement of the entire exhaled volume. Positioning and securing the mask must ensure that there are no leak. REF C04717-02-91 Q-NRG User Manual, Edition 4.2 63/148...
Page 66: Testing In Ventilator Mode
Connected to inhalation limb of patient circuit. REF A-820-173-002 USB flash drive To export test results Pole/Rail Clamp (optional) Necessary if pole/rail rather than flat surfaces available on patient area REF C04756-01-10 64/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2...
Page 67: Precautions/Contraindications
Every single use Flow-REE needs to be calibrated prior to VENTILATOR Mode measurement. To Calibrate Pneumotach 1. Unpack a new Flow-REE (single use) pneumotach and connect the tubes to the corresponding Q-NRG connectors (blue tube to blue connector, clear tube to white connector) as shown in the image below.
Page 68: Setting-Up Ventilator Mode
Setting-Up VENTILATOR Mode Q-NRG is designed to be used both with and without Heated Humidifier in the inspiratory limb of the patient circuit. Refer to the following table for proper use of accessories and their position in the different configurations.
Page 69 Make sure to connect Q-NRG to the patient circuit as shown below as quickly as possible. 1. Connect single use sampling line between the “Ventilator” port of Q-NRG and the inspiratory limb of the patient circuit through the dedicated FiO2 adapter placed at the inspiratory port of the Ventilator (If an antibacterial filter is present at the inspiratory port of Ventilator, recommended position of the FiO2 adapter is right after the filter).
Page 70: Operating Q-Nrg In Ventilator Mode
Shows averaged results within the specified interval (manually adjustable using the touch display) Data “Data” tab shows values in tabular format (updated every 30 seconds) During test, main parameters are updated every 30 seconds in both numerical and graphical formats 68/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2...
Page 71: Post-Test Cleaning & Disposal
Post-test Cleaning & Disposal To ensure patient safety, all the single use parts must be disposed of soon after the test and Q-NRG surface must be cleaned according to cleaning and disinfection instructions. For cleaning and disinfection procedures please refer to “Cleaning and Disinfection”.
Page 72: Testing In Canopy Mode
Canopy hose Reusable, it must be cleaned or replaced monthly REF C02678-01-07 Antibacterial filter Single use. Disposal after each test. REF A-182-300-004 USB flash drive To export results as soon as test completed 70/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2...
Page 73: Precautions/Contraindications
WARNING: • Canopy measurement shall only be performed under medical supervision. • Q-NRG shall NOT be placed onto a bed, to avoid the obstruction of the Canopy blower exhaust port, positioned at the bottom of the device. • DO NOT place the Canopy hood over the patient until the setup is complete, and the blower is on.
Page 74: Operating Q-Nrg In Canopy Mode
Shows real-time values (updated every 30 seconds) Shows averaged results within the specified interval (manually adjustable using the touch display) Data “Data” tab shows Realtime values in tabular format (updated every 30 seconds) 72/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2...
Page 75: Post-Test Cleaning & Disposal
Post-test Cleaning & Disposal To ensure the patient safety, all the single use parts must be disposed soon after the test and Q-NRG surface must be cleaned according to cleaning and disinfecting instructions. For cleaning and disinfection procedures please refer to “Cleaning and Disinfection”.
Page 76: Testing In Mask Mode
The seal inside the mask should fit from the top of the patient nose (between the eyes) to just below the bottom lip with the base of the mask going underneath the chin. 74/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2...
Page 77: Mask Mode Set-Up
2. Connect the turbine flowmeter electrical cable to the Q-NRG turbine flowmeter connector. 3. Connect a sampling line between the “Patient” port of Q-NRG and the port on the turbine flowmeter. 4. Place face mask, head cap and flowmeter on patient as shown in the image below.
Page 78: Post-Test Cleaning & Disposal
To ensure patient safety, all the single use parts must be replaced for each test and cleaning and disinfecting instructions should be strictly followed. The following table shows the disposable and reusable parts: Test mode Disposables Post-test cleaning MASK Sampling line Face mask Turbine Head cap Device surfaces 76/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2...
Page 79: Edit/Export/Print Results
Delete Patient Delete all tests belonging to the Patient under review Exporting Results 1. Insert a USB flash drive into one of the USB port on the left side of the Q-NRG. 2. Press CSV to USB PDF to USB 3.
Page 80 Login: Administrator Login: Administrator Page 1 / 2 Page 1 / 2 Q-NRG+ SN: 2018060015 Q-NRG+ SN: 2018060015 Canopy demo Canopy demo [ 02/26/1985 - Female ] Canopy demo Canopy demo [ 02/26/1985 - Female ] Canopy Test: 10/12/2018 14:50 Canopy Test: 10/12/2018 14:50 Time VP VO2 VCO2 RQ EE FeO2 FeCO2 FiO2 FiCO2 Battery Marker Info hh:mm:ss L/min mL/min mL/min - KCal/day % % % % % - 00:00:30 27.2 264 241 0.91 1864 19.70 1.19 20.87 0.10 59 0 00:01:00 27.1 259 234 0.90 1825 19.72 1.16 20.87 0.10 60 0 00:01:30 27.1 262 254 0.97 1873 19.69 1.25 20.87 0.10 60 0 00:02:00 26.9 241 252 1.05 1752 19.76 1.25 20.87 0.10 60 0 00:02:30 26.9 222 239 1.08 1625 19.84 1.19 20.87 0.10 60 0 00:03:00 26.8 214 214 1.00 1540 19.89 1.08 20.87 0.10 61 0 00:03:30 26.9 215 215 1.00 1548 19.89 1.08 20.87 0.10 61 0 00:04:00 27.2 239 219 0.92 1689 19.81 1.09 20.87 0.10 61 0 C 00:04:30 27.2 225 188 0.84 1561 19.89 0.95 20.87 0.10 61 0 A 00:05:00 27.1 233 196 0.84 1618 19.85 0.99 20.87 0.10 62 0 A 00:05:30 27.2 230 191 0.83 1594 19.87 0.96 20.87 0.10 62 0 A 00:06:00 27.1 230 199 0.87 1606 19.86 1.00 20.87 0.10 62 0 A 00:06:30 27.2 216 188 0.87 1510 19.92 0.95 20.87 0.10 63 0 A 00:07:00 27.1 218 201 0.92 1542 19.90 1.01 20.87 0.10 63 0 A 00:07:30 27.1 218 201 0.92 1542 19.90 1.01 20.87 0.10 63 0 A 00:08:00 27.1 224 209 0.93 1589 19.87 1.05 20.87 0.10 63 0 A 00:08:30 27.1 224 209 0.93 1589 19.87 1.05 20.87 0.10 64 0 A 00:09:00 27.2 227 201 0.89 1593 19.87 1.01 20.87 0.10 64 0 AC 00:09:30 27.0 227 194 0.85 1582 19.87 0.98 20.87 0.10 64 0 A 00:10:00 27.0 234 198 0.85 1627 19.84 1.00 20.87 0.10 64 0 78/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2...
Page 81: Chapter 4 - Omnia Software
COSMED srl Chapter 4 - OMNIA software Chapter 4 - OMNIA software REF C04717-02-91 Q-NRG User Manual, Edition 4.2 79/148...
Page 82: Introduction
This chapter describes the operation of Q-NRG using the OMNIA software (optional). OMNIA is a software platform developed by COSMED designed for data management, interpretation and reporting of all tests performed with the entire COSMED product range, from spirometry to lung function equipment and from metabolic to body composition assessment.
Page 83: Download Tests To Omnia
Chapter 4 - OMNIA software Download tests to OMNIA All tests performed with the Q-NRG can be downloaded to the computer for further analysis and editing. This functionality can only be performed when Q-NRG is connected to a Windows PC via USB or Bluetooth®.
Page 84: Reviewing Test Results In Omnia
Chapter 4 - OMNIA software COSMED srl Reviewing Test Results in OMNIA With OMNIA users can store an unlimited number of tests. Tests stored in the Database can be reviewed for data editing and reporting. 82/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2...
Page 85: Execute A Test From Omnia
Execute a test from OMNIA Tests can be remotely executed from OMNIA, once a valid USB or Bluetooth link with Q-NRG has been established. Q-NRG touch screen control is disabled when a test is controlled by OMNIA. Test data are simultaneously stored in the PC database and device memory.
Page 86 COSMED srl 84/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2...
Page 87: Chapter 5 - Maintenance
COSMED srl Chapter 5 - Maintenance Chapter 5 - Maintenance REF C04717-02-91 Q-NRG User Manual, Edition 4.2 85/148...
Page 88: Overview
COSMED srl Overview To keep Q-NRG clean, safe and efficient, it must be properly maintained as outlined in this chapter. • Any service operations not specified in this manual should only be performed by authorized personnel only in accordance with the service manual.
Page 89: Cleaning And Disinfection
Device and reusable parts are NOT supplied cleaned. Perform cleaning and disinfection procedure prior the very first use. COSMED components which come in contact with mucosa or non-intact skin are categorized as “semi-critical” devices and require high-level disinfection according to applicable guidelines (i.e. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.
Page 90: Disposable And Reusable Items For Each Test Mode
Disposable and Reusable Items for each Test Mode The following table summarizes the disposable items and the ones requiring cleaning procedures for each measurement mode. Test Mode Disposables Reusable(cleaning required) Device surfaces 88/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2...
Page 91 Antibacterial filter Canopy hood REF A-182-300-004 REF C03880-0X-10 Canopy veil Canopy hose REF C04690-0X-10 REF C02678-01-07 MASK Sampling line Mask REF A-180-100-002 REF C0361X-01-10 Head cap REF A-800-900-02X Turbine flowmeter REF C04770-01-04 REF C04717-02-91 Q-NRG User Manual, Edition 4.2 89/148...
Page 92: Reprocessing Methods For Reusable Items
Repeat the manual cleaning. Wipe device surface with another soft cloth moistened with water. Dispose the soft cloth. Drying Air dry Material Facts ABS plastic enclosure, glass display surface, Silicone rubber button and caps 90/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2...
Page 93 Drying if not. Note Do not disassemble adapters, doing so will damage hose. During test, it must be used in conjunc- tion with a COSMED antibacterial filter REF A-182-300-004. Material Facts ABS adapter, EVA tube REF C04717-02-91 Q-NRG User Manual, Edition 4.2...
Page 94 Drying if not. Note Do not iron the head cap assembly Material Facts Headgear: Polyurethane Foam, Nylon UBL Gray and Nylon Fabric Red. Headgear Hook: Nylon. Headgear Strap Clips (4): Polypropylene. 92/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2...
Page 95 Drying if not. Note Do not place the turbine under running water. Do not use Accelerated Hydrogen Peroxide (AHP) disinfectants to disinfect COSMED turbines since they can be chemically attacked, and the device may not perform well. Material Facts ABS plastic enclosure (black), MABS (Methyl Methacrylate / ABS) clear plastic enclosure, Fan blades (PET film), stainless steel axes, jewels, PC conveyors.
Page 96 Repeat manual cleaning. Wipe device surface with a soft cloth moistened with water. Dispose the soft cloth. Drying Air dry Material Facts ABS plastic, mesh Note: Components which have been disassembled have to be reassembled after reprocessing. 94/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2...
Page 97: Preventive Maintenance
Q-NRG back panel and battery must be removed. WARNING: To avoid the risk of electric shock, do not remove the back panel of the Q-NRG device while it is in operation or connected to the power. To Open Back Panel 1.
Page 98 ( the first screw. 4. Unscrew the second screw located just below the potential equalization node 5. Lift the back panel from the bottom part. 6. Remove the panel by lifting it. 96/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2...
Page 99 7. Remove the battery as described below before proceeding any preventive maintenance which requires access to the internal components. To Close the Back Panel 1. Re-insert the battery (flying label on bottom side). REF C04717-02-91 Q-NRG User Manual, Edition 4.2 97/148...
Page 100: Pneumatic Cartridge Replacement
Pneumatic Cartridge Replacement Some components of Q-NRG need to be replaced periodically to guarantee optimal performance. This procedure allows to replace the Pneumatic filters and Nafion dryer (integrated in the pneumatic cartridge) To Replace the Pneumatic Cartridge 1.
Page 101 7. Type in the Installation Date and LOT of the new Pneumatic Cartridge. Note Pneumatic cartridge replacement shall be performed every 350 tests. Q-NRG device prompts a warning message when the maintenance is required. REF C04717-02-91 Q-NRG User Manual, Edition 4.2 99/148...
Page 102: Fan Filter Replacement
2. Open the fuses locker with the aid of a straight slotted screw driver to access the two mains fuses. 3. Carefully extract the tray and replace the fuses according to the labelling. Note: Perform when necessary. 100/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2...
Page 103: O2 Sensor Replacement
O2 sensor replacement The installation of the O2 sensor is necessary in the following situations: • Before first use: Q-NRG is supplied without the O2 sensor installed. • The message “O2 sensor exhausted” is prompted during analyzer calibration. • The O2 sensor has been installed more than 12 months ago (there will be a warning message at power on).
Page 104 4. Disconnect the electrical connector. 5. Unpack the new sensor and connect the electrical connector and repeat the procedure in the reverse order. 6. Be sure to pull down the new sensor on the receptacle. 102/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2...
Page 105 SETTINGs/MAINTENANCE. 9. Type in the Installation Date and Serial Number of the new sensor. Note: Expected Sensor Lifespan is 12 months in room air; measurements at higher O2% will decrease life span. REF C04717-02-91 Q-NRG User Manual, Edition 4.2 103/148...
Page 106: Firmware Update
1. Make sure that the battery has at least 20% remaining capacity or that the device is connected to mains. 2. Turn the device Off. 3. Plug the USB flash drive device with the firmware into any USB port on the side of Q-NRG. Make sure there is only one USB drive inserted.
Page 107: Battery Installation And Removal
If the smart battery is not fully discharged each time, the number of cycles available over life will increase. Q-NRG battery information can be found by tapping the Info button located at the bottom right corner of the main screen.
Page 108: Update Q-Nrg Licenses
Additional hardware/software functions can be added to Q-NRG which require activation. Activation keys are encrypted and stored in the non-erasable section of the internal memory of the device. Note: License activation can be only performed by connecting Q-NRG to a PC with OMNIA Licenser via a USB cable. Update Q-NRG Licenses 1.
Page 109: Chapter 6 - Troubleshooting
COSMED srl Chapter 6 - Troubleshooting Chapter 6 - Troubleshooting REF C04717-02-91 Q-NRG User Manual, Edition 4.2 107/148...
Page 110: Miscellaneous Problems
Inspect turbine and optoelectronic shown on LCD (MASK Mode) Volume or IN/EX) because: reader assembly -electronic reader not properly Re-calibrate the turbine connected Replace turbine -turbine rotor does not rotate -optoelectronic reader broken 108/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2...
Page 111 Ignore warning message at high altitude altitude Test results Non-Physiological Miscellaneous factors Repeat all calibration procedures Access Calibration/Cal. Factors menu, compare results with normal ranges (in user manual). Contact customer support providing test results REF C04717-02-91 Q-NRG User Manual, Edition 4.2 109/148...
Page 112: Error Messages And Notifications
COSMED srl Error Messages and Notifications Q-NRG may prompt some of the messages listed below to highlight technical errors and failures. Notification messages not related to error/problem may also be prompted when operating the device and are not listed in this chapter.
Page 113 During Canopy test dilution flow is Remove Canopy hood as soon as possi- not detected due to blower or internal ble and contact technical service Blower Ventilation not detected, flowmeter failure remove the Canopy hood from patient. REF C04717-02-91 Q-NRG User Manual, Edition 4.2 111/148...
Page 114 Prepare the USB key, turn the unit off #1032 #1033 #1104 #1105 #1106 mission (e.g. USB device not found, and try again #1107 #1110 #1111 #1113 not FW update file found, ….) Refer to “Firmware Update” section 112/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2...
Page 115 Advanced Test Notification During Canopy test CO2 Decrease Blower ventilation and wait for stable concentration is lower than values CO2 concentration is low, what is specified in Settings/ decrease blower ventilation Advanced REF C04717-02-91 Q-NRG User Manual, Edition 4.2 113/148...
Page 116 Test Notification Ventilator test duration Terminate the test to avoid possible water exceed 30 minutes condensation within the sampling line Test duration exceeding 30 minutes limit. Potential water condensation within sampling line 114/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2...
Page 117: Bluetooth Troubleshooting
Q-NRG can be paired (not simultaneously) with multiple PCs. Moving the same BTA from one PC to another requires re-pairing process. If the pairing process between Q-NRG and BTA or wireless link fails, please follow the actions summarized below. Check for pending Windows software updates 1.
Page 118: Verify That Bluetooth Drivers Are Properly Installed
4. Run OMNIA and try the pairing process. Uninstall Q-NRG Paired Device You may need some time, for various reason or to resolve possible system conflicts to unpair a specific Q-NRG to a PC. To do so please follow the procedure described below.
Page 119: Change The Usb Port
Device Manager. 4. Under View menu enable Show hidden devices 5. Under Bluetooth section look for Q-NRG devices greyed out and uninstall them with mouse right click. 6. Disconnect and re-connect BTA to PC. 7. Restart PC. 8. Run OMNIA and try the pairing process.
Page 120: Disable Power Management Options
Bluetooth and Wi-Fi networks share the same frequency range (2.4GHz); sometimes, even if are both networks designed for coexistence, wireless interferences may occur. Interferences may arise due to the Wi-Fi radio of the same PC where the BTA is installed or a nearby device. Turn off nearby Wi-Fi stations and verify again Q-NRG wireless performance.
Page 121: Appendix
COSMED srl Appendix Appendix REF C04717-02-91 Q-NRG User Manual, Edition 4.2 119/148...
Page 122: Ce Declaration Of Conformity
Appendix COSMED srl CE Declaration of Conformity 120/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2...
Page 123: Emc Conformity
Max power (W) Distance (m) Immunity test level duty cycle) (V/m) Pulse modulation 18 Hz Pulse modulation 18 Hz Pulse modulation 217 Hz Pulse modulation 18 Hz 1720 Pulse modulation 217 Hz 1845 1970 REF C04717-02-91 Q-NRG User Manual, Edition 4.2 121/148...
Page 124 6 V r.m.s. in ISM bands* 80% AM at 1 kHz * ISM bands: 6.765 MHz to 6.795 MHz, 13.553 MHz to 13.567 MHz, 26.957 MHz to 27.283 MHz, 40.66 MHz to 40.70 122/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2...
Page 125: Iec 62353 Safety Test
Any volume in which intentional or unintentional contact can occur between a patient and parts of the medical electrical equipment or medical electrical system or between a patient and other person touching parts of the medical electrical equipment or medical electrical system. REF C04717-02-91 Q-NRG User Manual, Edition 4.2 123/148...
Page 126: Visual Inspection
• The required documentation is available and reflects the current revision and/or configuration. After testing, repair or adjustment, check that the device is restored to the conditions necessary for intended use before being returned into service. 124/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2...
Page 127: Protective Earth Resistance
Test Protective earth resistance Classification Class I with detachable power cord Accessible conductive parts which may become live in Potential Equalization Node case of a fault Acceptance criteria <300mOhm (including power cord) REF C04717-02-91 Q-NRG User Manual, Edition 4.2 125/148...
Page 128: Equipment Leakage Current
Single use flowmeter (Flow-REE) Sampling lines Canopy hose with filter Face Mask with external turbine flowmeter Equipment acceptance criteria 500uA (Normal, Reversed mains) Applied Parts acceptance criteria 5000uA (Normal, Reversed mains, battery oper.) 126/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2...
Page 129: Warranty And Service Policy
Liability for products covered by this warranty is limited to the replacement, repair or issuance of a credit for the cost of a defective product at the discretion of COSMED. The following conditions must exist for the warranty to apply: 1.
Page 130: Other Information
Refer to guidelines reported in the References of this appendix and specific country regulations. Environmental condition of use COSMED units should not be operated near explosive substances. Device should not be installed near electrical or magnetic devices such as x-ray equipment, transformers or power lines. These devices could create electrical interferences when performing testing procedures.
Page 131: Accessories/Spare Parts
VENTILATOR, CANOPY (*) and MASK (*) modes * optional feature, additional components required Accessories Description Image A-201-901-003 Q-NRG/Q-NRG+ Cover A-258-900-002 Q-NRG/Q-NRG+ Cart with Cylinder Holder w/o clamp A-800-900-022 V2 Mask – Head Cap (Large) REF C04717-02-91 Q-NRG User Manual, Edition 4.2 129/148...
Page 132 Syringe Small adapter A-108-300-012 Corrugated tube for adapter C03179-01-11 Canopy Hood Kit, LARGE size (Canopy hood+Canopy hose+canopy backpack) C03179-03-11 Canopy Hood Kit, SMALL size (Canopy hood+Canopy hose+canopy backpack). Not available in US. 130/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2...
Page 133 V2 Mask for RMR flowmeter (Small) C03618-01-10 V2 Mask for RMR flowmeter (Medium) C03619-01-10 V2 Mask for RMR flowmeter (Large) C04251-01-51 Canopy Hood Protection Bag C04656-02-11 Q-NRG/Q-NRG+ Mask Kit (2 masks, 1 Head Cap, 1 External Flowmeter) REF C04717-02-91 Q-NRG User Manual, Edition 4.2 131/148...
Page 134 Antibacterial Filter (50 pcs) A-182-300-006 HME Heat Moisture Exchanger with Antibacterial Filter (50 pcs) A-182-300-007 Antibacterial Filter (50 pcs) A-662-250-003 Flow-REE, single use flow sensor (10 pcs) A-820-173-002 Q-NRG+ Adapter, FiO2 to Ventilator (50 pcs) 132/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2...
Page 135 Description Image A-410-750-006 Q-NRG/Q-NRG+ Li-Ion Smart Battery A-558-250-005 Gas Sensor, O2 GFC Oxygen Cell A-750-900-008 Q-NRG/Q-NRG+ Fan Filter Pad 100g C02678-01-07 Q-NRG/Q-NRG+ Canopy Hose (200 cm length) C04778-01-10 Q-NRG Back panel assembly REF C04717-02-91 Q-NRG User Manual, Edition 4.2 133/148...
Page 136 Appendix COSMED srl C04778-02-10 Q-NRG+ Back Panel Assembly C04790-01-11 Q-NRG/Q-NRG+ Pneumatic Replace- ment Kit (cartridge, fan filter) C04882-01-11 Q-NRG/Q-NRG+ Cardboard Packag- ing w/internal spacers 134/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2...
Page 137: Intellibridge Interface
This section details the information needed to connect Q-NRG+ to Philips multiparameter monitors through Philips IntelliBridge Interface. This allows the Philips monitor to display Q-NRG+ data on screen and send it to a central monitoring system. Note: IntelliBridge Interface is only available in VENTILATOR mode.
Page 138: Connection Diagrams
Connection diagrams Philips Q-NRG+ Philips IntelliBridge Multiparameters Monitor The following diagram shown how to connect the Q-NRG+ system to Philips multiparameter monitors using the EC5 ID module P/N 865114 #104 Female DB9. Q-NRG+ Ethernet cable Q-NRG+ serial port EC10 module...
Page 139: Compatible Philips Monitors
• Philips IntelliVue MX400/450/500/550/600/700/800, all software revisions • Philips IntelliBridge System C.0 (standalone discontinued) • Philips IntelliVue Information Centre PIIC iX A.0 (discontinued) and PIIC iX B.0 • Philips Patient Information centre PIC iX C.0 or higher REF C04717-02-91 Q-NRG User Manual, Edition 4.2 137/148...
Page 140: Safety And Conformity
Canopy hose with filter Face Mask with external turbine flowmeter FCC/IC The Q-NRG complies with the following requirements: • FCC (Federal Communications Commission) Title 47 Part 15 Paragraph 107, 109. • IC (Industry Canada) ICES-003 Issue 6. Operation is subject to the following two conditions: 1.
Page 141 - Increase the separation between the equipment and receiver. - Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. - Consult the dealer or an experienced radio/TV technician for help. REF C04717-02-91 Q-NRG User Manual, Edition 4.2 139/148...
Page 142: Technical Specifications
RCM, IEC 62133, UN 38.3 ,RoHS, REACH, BIS RCM, IEC 62133, UN 38.3 ,RoHS, REACH, BIS, TISI, BSMI Storage temperature: -20°C to 50°C max, -20°C to 25°C -20°C to 50°C max, -20°C to 25°C recommended recommended 140/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2...
Page 143 <0.45 cmH2O*s/l @ 1 L/s Oxygen Sensor (O2) Type: Galvanic Fuel Cell Range: 0-75% Resolution: 0.01% Vol Accuracy: <0.05% Vol Carbon Dioxide Sensor (CO2) Type: Digital infrared Range: 0-10% Resolution: 0.01% Vol Accuracy: <0.05% Vol REF C04717-02-91 Q-NRG User Manual, Edition 4.2 141/148...
Page 144 BT qualification ID: B015141 (QDID 22298) Contains FCC ID: QOQWT41u Contains IC: 5123A-WT41u Wired Connectivity USB-device (5 kV galvanic- Insulated) 2x USB Host Serial RS232 (5 kV galvanic- Insulated) Ethernet 5 kV galvanic- Insulated 142/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2...
Page 145: Embedded Software Specifications
• qrencode-4.02, licensed under the terms of the LGPLv2.1; Cosmed did not modify the source code. • e2fsprogs-1.44.3, licensed under the terms of the GPLv2 or LGPLv2.1 or BSD or MIT; Cosmed relies on the GPLv2 license; Cosmed did not modify the source code.
Page 146 For your convenience, some or all of the source code may also be found at: • https://github.com/crosstool-ng/crosstool-ng/archive/crosstool-ng-1.22.0.zip • https://mirrors.edge.kernel.org/pub/linux/utils/util-linux/v2.28/util-linux-2.28.tar.gz • https://github.com/fukuchi/libqrencode/archive/v4.0.2.zip • https://mirrors.edge.kernel.org/pub/linux/kernel/people/tytso/e2fsprogs/v1.44.3/e2fsprogs-1.44.3.tar.gz • https://github.com/mpetazzoni/tslib/archive/tslib-1.5.zip • https://download.qt.io/archive/qt/5.9/5.9.2/single/qt-everywhere-opensource-src-5.9.2.zip Integral version of the licenses can be found on Q-NRG device selecting Info/Open Source Licenses (see “Device Info”). 144/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2...
Page 147: References
Cleaning and disinfection William A. Rutala, Ph.D., M.P.H., David J. Weber, M.D., M.P.H., and the Healthcare Infection Control Practices Advisory Committee (HICPAC): Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 (http:// www.cdc.gov/hicpac/pdf/guidelines/Disinfection_Nov_2008.pdf) REF C04717-02-91 Q-NRG User Manual, Edition 4.2 145/148...
Page 148: Notes
Appendix COSMED srl Notes 146/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2...
Page 149 COSMED srl Appendix REF C04717-02-91 Q-NRG User Manual, Edition 4.2 147/148...
Page 150 Appendix COSMED srl 148/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2...
Page 152 COSMED Srl  Via dei Piani di Monte Savello 37 Albano Laziale - Rome 00041, Italy +39 (06) 931-5492 Phone +39 (06) 931-4580 Fax info@cosmed.com | cosmed.com...

Cosmed Q-NRG User Manual

Chapter 1 - Get Started

Chapter 2 - Installation

Chapter 3 - Q-NRG Operation

Chapter 4 - OMNIA Software

Chapter 5 - Maintenance

Chapter 6 - Troubleshooting

Appendix

Quick Links

Troubleshooting

Need help?

Questions and answers

Related Manuals for Cosmed Q-NRG

Summary of Contents for Cosmed Q-NRG

Table of Contents