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

Chapter 1 - Get Started

COSMED srl

Indicates the Authorized representative
in the European Community
(ISO 15223-1, Clause 5.1.2)

Indicates the need for the user to consult the
instructions for use
(ISO 15223-1, Clause 5.4.3)

Indicates the medical device manufac-
turer
(ISO 15223-1, Clause 5.1.1)

UDI data matrix

Do not open the package using a sharp
tool

O2 sensor

Symbol

Description

Symbol

Description

Harmful
(Symbol GHS-07)

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

Description

Harmful
(Symbol GHS-07)

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

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

Mark of conformity to applicable European
Directives

UN Transportation Test

Regulatory Compliance Mark of Japan

Содержание Q-NRG

Страница 1: ...Q NRG User Manual...

Страница 2: ......

Страница 3: ...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 docu...

Страница 4: ...andTransportation 15 Oxygen Sensor Safety Storage andTransportation 16 Glossary of symbols 17 Introduction to Indirect Calorimetry 21 Device Overview 22 Measurement Modes 23 VENTILATOR 23 CANOPY 23 MA...

Страница 5: ...5 Utility 46 Export Import Erase 46 Control Panel 47 Calibration 49 DeviceWarm Up 49 Required Calibration Procedures 49 Calibration Menu 50 Pneumotach VENTILATOR Mode 50 Gas Analyzers Cylinder 51 Gas...

Страница 6: ...rating 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 Disposa...

Страница 7: ...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...

Страница 8: ...ng of electrical equipment 128 Accessories Spare Parts 129 DeviceVersions 129 Accessories 129 IntelliBridge Interface 135 Connection diagrams 136 Operating Q NRG with Philips IntelliBridge 136 Compati...

Страница 9: ...7 148 REF C04717 02 91 Q NRG User Manual Edition 4 2 Chapter 1 Get Started COSMED srl Chapter 1 Get Started...

Страница 10: ...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...

Страница 11: ...sonnel Technical background and awareness on hazards and risks associated with the performed procedures are required Service personnel must be authorized by COSMED or COSMED affiliates Repair Complex...

Страница 12: ...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...

Страница 13: ...missions 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...

Страница 14: ...or 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...

Страница 15: ...60 minutes three or four times in two weeks Note Thedevice programalgorithmsanddatapresentationhavebeendevelopedinaccordancewiththe recommendationsoutlinedincurrentscientificguidelinesandliterature t...

Страница 16: ...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 Stateme...

Страница 17: ...here 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 mechanica...

Страница 18: ...olvents 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 li...

Страница 19: ...al law restricts this device to sale by or on the order of a licensed healthcare practitioner US market only 21 CFR 801 109 Indicates the manufacture s catalogue number so that the medical device can...

Страница 20: ...dling the package ISO 7000 0622 Indicates the temperature limits to which the medical device can be safely exposed ISO 15223 1 Clause 5 3 7 Indicates a medical device that needs to be protected from m...

Страница 21: ...mful Symbol GHS 07 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...

Страница 22: ...EF C04717 02 91 Q NRG User Manual Edition 4 2 Chapter 1 Get Started COSMED srl EAC Gost Regulatory Compliance Mark of Australia and New Zealand UL Recognized for Canadian and US market China CQC KC In...

Страница 23: ...results Resting energy expenditure REE or energy expenditure measured in resting conditions either on spontaneously breathing or ventilated subjects has a number of useful clinical applications refer...

Страница 24: ...ortable 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...

Страница 25: ...s not available these sampling lines transport samples of gases exhaled and inhaled for the measurement of O2 oxygen and CO2 carbon dioxide concentrations Further calculations allow determination ofVO...

Страница 26: ...ter 1 Get Started COSMED srl MASK A reusable face mask available in 5 different sizes attached to the external turbine flowmeter allows for the measurement ofVO2 andVCO2 in spontaneously breathing sub...

Страница 27: ...ptacles D Technical failure LED Q Calibration gas port E External turbine flowmeter R Ethernet technical purposes only F Sampling line Patient S USB type B PC connection G Sampling line Ventilator T R...

Страница 28: ...s requires a fresh set of the following single use items The test requires an antibacterial filter provided with a Luer lock that may be already available in the patient circuit In case the antibacter...

Страница 29: ...asurements by means of a silicone face mask available in 5 different sizes The kit consists of two masks small and medium size one mask adapter one reusable turbine flowmeter and one head cap small me...

Страница 30: ...4 and pressure regulator REF A 870 155 001 allows gas calibration of Q NRG analyzers See also Calibration Cylinder Set up A Cylinder B Pressure Regulator Pole Rail Clamp withVESA Mounting Plate This o...

Страница 31: ...intenance Periodically inspect all hardware associated with the mounting system Tighten or adjust as necessary for optimal operation and safety To prevent possible device damage avoid tipping over the...

Страница 32: ...30 148 REF C04717 02 91 Q NRG User Manual Edition 4 2 COSMED srl...

Страница 33: ...31 148 REF C04717 02 91 Q NRG User Manual Edition 4 2 Chapter 2 Installation COSMED srl Chapter 2 Installation...

Страница 34: ...Refer to IEC 62353 safety test in the Appendix of this user manual Potential Equalization Node The purpose of additional potential equalization is to equalize potentials between different metal parts...

Страница 35: ...ged 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 To Power ON the Device 1 Press a...

Страница 36: ...ut Second Stage E Pressure Adjustment Knob C Calibration Hose WARNING BesurethattheGasCylinderisalwayssafelysecuredinthecylinderholderoftheoptionalcart referto cartinstructions orinanotherappropriatem...

Страница 37: ...nob is closed turning it completely counter clockwise 3 Ensure that the ON OFFValve is closed Vertical Position the valve will be perpendicular to the output line 4 Connect the hose to the Q NRG calib...

Страница 38: ...stem Windows 7 SP1 32 Bit Windows 10 64 Bit Screen Resolution 1366 x 768 1920 x 1080 USB Port Integrated Bluetooth USB Bluetooth to communicate with Q NRG 1 USB N A Note Thesoftwareiscopyrightprotecte...

Страница 39: ...d on and radio communication enabled see Settings Power Saving mode disabled on computer Be sure that Bluetooth drivers are properly installed For further details refer to BluetoothTroubleshooting Not...

Страница 40: ...38 148 REF C04717 02 91 Q NRG User Manual Edition 4 2 COSMED srl...

Страница 41: ...39 148 REF C04717 02 91 Q NRG User Manual Edition 4 2 Chapter 3 Q NRG Operation COSMED srl Chapter 3 Q NRG Operation...

Страница 42: ...notexactlymatchwhatyouseeonyourowndevice Home Page and Main Functions Tile Functionality NewTest Execute a new test choose among the existing patients in the archive using the Search Patient function...

Страница 43: ...t without saving Close Close the current page Save or Save OK Confirm and proceed Start Start test calibration Defaults Restore Default settings e g calibration results Factory Settings Reset the devi...

Страница 44: ...button the display will be greyed and the Lock symbol flashes in background 2 To cancel the screen Lock press the Lock button again This functionality can be used when cleaning Function enabled press...

Страница 45: ...Enable Disable audible feedback ScreenTimeout min Set time before screen sleeps Bluetooth Turn ON OFF Bluetooth radio Canopy Mode Enable Disable CANOPY Mode test and features Canopy Kit must be purch...

Страница 46: ...tabolism UM Select the unit of measurement for substrate visualization kcal day g day Mask FlowmeterTemp C Temperature at flowmeter during mask test C Printout Printout menu allows configuration of fa...

Страница 47: ...port Series vol 724 pp 1 206 1985 Maintenance Maintenance menu shows details about the maintenance performed on the device Further information about Preventive Maintenance and O2 Sensor Installation c...

Страница 48: ...BMaxstoragesize 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 Utility Exporttest To Import Database from a USB fl...

Страница 49: ...o air flow is moving through sensor Calibrate CO2 Zero Set the baseline for CO2 Blower KNOB Adjust Canopy blower flow rate 0 100 Blower ON OFF Turn blower pump On or Off Unit mV Toggle between calibra...

Страница 50: ...leaks according to a specific procedure to be performed by authorized service centers only Acquire Data Set pneumatic circuit in acquisition mode and freeze measured signals O2 trimmer Set O2 hardwar...

Страница 51: ...requires monthly gas analyzers calibration This section describes all calibration procedures Operators and Experts are recommended to read only paragraphs applicable to their role see table below Dev...

Страница 52: ...entilated subjects The pressure drop across the transparent flexible plastic screen is directly proportional to the amount of air flow passing through the flowmeter To achieve the maximal possible acc...

Страница 53: ...fied values from the actual gas cylinder must be specified in calibration Calibration Factors References This procedure consists of a two point calibration room air and a known reference calibration g...

Страница 54: ...O2 range 22 or 75 and compensate for sensor aging Correction factors necessary to match actual reading of O2 and CO2 with expected values room air will be calculated Note Thiscalibrationprocedureisasu...

Страница 55: ...ole motion range in 8 12 seconds Turbine External Flowmeter MASK Mode The turbine calibration is achieved by comparing a known volume calibration syringe against the volume measured by the system and...

Страница 56: ...gs Tap Defaults and confirm The acceptable ranges and default values are summarized in the following tables Pneumotach VENTILATOR Mode Cal Factor Acceptable range Default Note Last mm dd yyyy hh mm Da...

Страница 57: ...ime since power on Ambient Pressure mmHg Ambient Pressure during calibration Analyzer Pressure mmHg Analyzers Pressure during calibration O2Trimmer 10 1000 O2 hardware span O2 Gain 800 1200 O2 softwar...

Страница 58: ...to store the test 7 Edit Results and Save Changes Select the averaging interval Review and edit the test results and patient s info if necessary 8 Export Results Export in CSV or PDF format USB port E...

Страница 59: ...orytostartthe measurement Missingorincorrectvaluescanbeedited To Enter New Patient Data 1 Tap NewTest and then NEWPATIENT 2 Enter Last First Name DOB Date of Birth Gender Weight and Height This inform...

Страница 60: ...rval advanced editing edit complete additional data USB or Bluetooth Paper PDF CSV COSMED proprietary XML For for further details refer to Edit Export Print Results Disposable and Reusable Items for e...

Страница 61: ...C04690 0X 10 Via dei Pi a ni di Monte Savello 37 Albano Laziale 00041 Rome I T ALY Disposab l e Veil for Canopy Hood Large Reorde r C04690 01 10 106kPa 60kPa 95 50 C 122 F 10 C 14 F cosmed co m To be...

Страница 62: ...min Dilution flow CANOPY RQ_avg mL min Averaged RQ All FAT or kcal day or g day Fat substrate metabolism All CHO or kcal day or g day Carbohydrate substrate metabolism All PRO or kcal day or g day Pr...

Страница 63: ...4 2 Chapter 3 Q NRG Operation COSMED srl N Step has been identified as an artifact F FiO2 reading performed during current step Z Automatic zeroing of PNT pressure sensor performed during current ste...

Страница 64: ...ircuit consider performing the measurement whenever the patient filter is changed according to your ICU policy Avoid changing FiO2 settings on ventilator during a measurement FiO2 during the selected...

Страница 65: ...ccuracy CANOPY Mode The veil must be carefully wrapped around the patient to avoid air leaks which may causeVO2 andVCO2 underestimation Blower flow rate within the selected averaging interval shall be...

Страница 66: ...use flowmeter REF A 662 250 003 HME Heat Moisture Exchanger with Antibacterial filter REF A 182 300 006 To be used when no active humidifi cation is present Antibacterial Filter REF A 182 300 007 To...

Страница 67: ...racheal tube cuffs or uncuffed tubes are tolerated Maximum duration of a unique test is 30 minutes to avoid potential water condensation within sampling line Select Patient 1 Select or add a new patie...

Страница 68: ...te Patient stolerancetotheadditionalfilterdeadspaceshouldbeaddressedbeforetestexecution Note Ventilatorandaccessoriesmaydifferfromtheexamplesshownintheimagesbelow presenceofthe antibacterialfilteratth...

Страница 69: ...r is present at the inspiratory port ofVentilator recommended position of the FiO2 adapter is right after the filter 2 Connect single use sampling line between the Patient port of Q NRG and HME filter...

Страница 70: ...the following commands Command Function Start Recording Begin storage of data test time will reset Stop Recording End test storing all data Info Review edit additional test info UN Fasting Period Res...

Страница 71: ...nal filter HME or Standard has been added to the patient s circuit for the sole purpose of the test remove it at the end of test Post test Cleaning Disposal To ensure patient safety all the single use...

Страница 72: ...eil is properly placed over the Canopy hood to avoid air leaks Via dei Pi a ni di Monte Savello 37 Albano Laziale 00041 Rome I T ALY Disposa ble Veil for Canopy Hood Large Reord er C0469 0 01 1 0 106k...

Страница 73: ...be prompted during test execution Setting Up Canopy 1 Place the single use veil over the Canopy hood according to the instructions printed on the veil packaging connect the Canopy hose and the antibac...

Страница 74: ...mfortablyrelaxed Measuredvaluesimmediatelyafterdilutionflowchangesarenot reliable Averageintervalshouldnotincludedilutionflowadjustments During test execution the user interacts with the device via th...

Страница 75: ...st 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 instructio...

Страница 76: ...e device Sampling line REF A 180 100 002 Single use Disposal after each test Reusable head cap REF A 800 900 02X Reusable face mask REF C0361X 01 10 Chose appropriate size before starting the measurem...

Страница 77: ...or create a new patient and tap MASK 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...

Страница 78: ...real time values updated every 30 seconds AVG Shows results averaged within the specified interval manually adjustable using the touch display Data Data tab shows Realtime values in tabular format up...

Страница 79: ...lect the Best 5 minutes CSV to USB Export test results to USB flash drive in numerical format PDF to USB Export test results to USB flash drive in PDF format Exit Exit theTest Results Make the followi...

Страница 80: ...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...

Страница 81: ...79 148 REF C04717 02 91 Q NRG User Manual Edition 4 2 Chapter 4 OMNIA software COSMED srl Chapter 4 OMNIA software...

Страница 82: ...r or standalone computer Remote test execution Advanced data analysis and data export Customizable reports Integration with Hospital Information Systems HL7 or GDT Refer to the OMNIA user manual for d...

Страница 83: ...Tests on a PC 1 Ensure OMNIA software is installed and running on the PC 2 Click Download Tests in the HOME page of OMNIA software 3 Click VIEWDATA to show the list of tests stored on the Q NRG memory...

Страница 84: ...NRG User Manual Edition 4 2 Chapter 4 OMNIA software COSMED srl ReviewingTest Results in OMNIA With OMNIA users can store an unlimited number of tests Tests stored in the Database can be reviewed for...

Страница 85: ...r modify additional test info UN body temperature agitation AVG REE Adjust the averaging interval s for the calculation of REE Interpretation Insert test comments or interpretation Execute a test from...

Страница 86: ...84 148 REF C04717 02 91 Q NRG User Manual Edition 4 2 COSMED srl...

Страница 87: ...85 148 REF C04717 02 91 Q NRG User Manual Edition 4 2 Chapter 5 Maintenance COSMED srl Chapter 5 Maintenance...

Страница 88: ...after cleaning and disinfection parts remain dirty repeat cleaning and disinfection procedures Because some environments cause a quicker collection of lint and dust than others inspect the fan filter...

Страница 89: ...n independent test laboratory Re processable parts when maintained properly and reprocessed per these instructions should function within specifications for a minimum of 50 cycles Verify proper functi...

Страница 90: ...the device To minimize the potential for infection and ensure optimal performance make sure that Device and re processable parts are cleaned and disinfected prior the very first use Disposable items...

Страница 91: ...CANOPY Antibacterial filter REF A 182 300 004 Canopy hood REF C03880 0X 10 Canopy veil REF C04690 0X 10 Via dei Pi a ni di Monte Savello 37 Albano Laziale 00041 Rome I T ALY Disposab l e Veil for Can...

Страница 92: ...evel disinfection When Immediately after use Pre treatment Close all protection caps to correspondent receptacles Wipe off any visible soil with a moist sponge or towel Manual Cleaning When cleaning d...

Страница 93: ...d outside wipe and rinse in water at 22 40 C 72 104 F Manual Cleaning Soak for 3 minutes in an enzymatic solution e g Cidezyme at room temperature 22 C 72 F During the 3 minutes using a soft bristle b...

Страница 94: ...et air dry Inspect all surfaces and item features to ensure that they are visibly dry repeat Drying if not Note Disassemble all parts before cleaning Material Facts Silicone rubber blue Polycarbonate...

Страница 95: ...hem off out or dab with a lint free cloth and let air dry Inspect all surfaces and item features to ensure that they are visibly dry repeat Drying if not Note Do not place the turbine under running wa...

Страница 96: ...oft cloth moistened with water Dispose the soft cloth Drying Air dry Material Facts EVA copolymer Corrugated tube for adapter Level of Reprocessing Low level disinfection When Immediately after use Pr...

Страница 97: ...access Q NRG replaceable parts the Q NRG back panel and battery must be removed WARNING Toavoidtheriskofelectricshock donotremovethebackpaneloftheQ NRGdevicewhileitisin operationorconnectedtothepower...

Страница 98: ...Maintenance COSMED srl 3 Open the cover at the bottom left part of the back cover to unscrew the first screw 4 Unscrew the second screw located just below the potential equalization node 5 Lift the b...

Страница 99: ...n 4 2 Chapter 5 Maintenance COSMED srl 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 R...

Страница 100: ...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 cartridg...

Страница 101: ...te the maintenance schedule be sure to align the new pneumatic cartridge with the reference poles 5 Refer to To Close the Back Panel to re insert the battery and closing the device 6 Turn the device O...

Страница 102: ...ntamination To Replace the Fan Filter 1 Pull out the fan filter A 750 900 008 from its socket in the back panel 2 Insert a new fan filter into the socket make sure it is free of folds Mains fuses repl...

Страница 103: ...irst 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 b...

Страница 104: ...5 Maintenance COSMED srl 3 Lift and gently remove the sensor 4 Disconnect the electrical connector 5 Unpack the new sensor and connect the electrical connector and repeat the procedure in the reverse...

Страница 105: ...5 Maintenance COSMED srl 7 Close the back panel 8 Turn the device ON and select SETTINGs MAINTENANCE 9 Type in the Installation Date and Serial Number of the new sensor Note ExpectedSensorLifespanis1...

Страница 106: ...s the firmware update file can be present in the file system The firmware update procedure does not write anything to the USB flash drive device therefore every file is left unchanged Install Firmware...

Страница 107: ...rderareplacementwhennecessary Due to increasing safety concerns raised by the aviation industry the IATA regulations governing the shipping of Lithium Batteries have been tightened and airlines are en...

Страница 108: ...ioncanbeonlyperformedbyconnectingQ NRGtoaPCwithOMNIALicenserviaaUSB cable Update Q NRG Licenses 1 Connect Q NRG to the PC via an USB cable 2 FromWindows Start menu launch COSMED OMNIALicensers and sel...

Страница 109: ...107 148 REF C04717 02 91 Q NRG User Manual Edition 4 2 Chapter 6 Troubleshooting COSMED srl Chapter 6 Troubleshooting...

Страница 110: ...device as described in Maintenance Upgrade Firmware Touchscreen not responding to commands Lock screen active Unlock the screen by holding the unlock icon OMNIA SW freezes during Bluetooth pairing Wit...

Страница 111: ...ge filter and register the test Verify received breath values for further troubleshooting End test from device and download data again to PC O2 sensor exhausted message during gas calibration O2 senso...

Страница 112: ...leandrefertothecorrectiveactionwhen available List of Error Messages Message Cause Corrective action Error 100 Detected flow too low Flow during Pneumotach calibration is lower than expected Check the...

Страница 113: ...message Error 109 Calibration flow too low During pneumotach calibration internal turbine flow is too low Calibrate internal flowmeter according to instructions InternalTurbine Flowmeter Blower Calibr...

Страница 114: ...months Refer to the related maintenance proce dure O2 sensor replacement Error 416 More than 350 tests performed since last Pneumatic Cartridge replacement Maintenance Required Pneumatic Cartridge wit...

Страница 115: ...ed to mains Battery Notification Battery is critically low device is turning off connect the device to the mains Battery level has reached 5 device will be automatically turned off in few seconds Char...

Страница 116: ...ent anyway Test execution requires 5 minutes warm up Wait for 5 minutes before performing test Test Notification Current test results appear technically questionable carefully evaluate if suitable for...

Страница 117: ...rocess If the pairing process between Q NRG and BTA or wireless link fails please follow the actions summarized below Check for pendingWindows software updates 1 Check if there any pendingWindows soft...

Страница 118: ...process Verify that Bluetooth Drivers are Properly Installed To Check Bluetooth drivers 1 Ensure that the BTA is connected to PC 2 Open ControlPanel Device Manager and access Bluetooth section 3 Veri...

Страница 119: ...ng in background could interfere with BTA They should be stopped Here is a known list of them Process Description Bttray exe This process is known as BluetoothTray Application or Bluetooth Application...

Страница 120: ...o turn off this device to save power 6 Repeat 4 5 for all Generic USB Hub and USB Root Hub 7 Run OMNIA and try the pairing process Wi Fi Network Interference Bluetooth andWi Fi networks share the same...

Страница 121: ...119 148 REF C04717 02 91 Q NRG User Manual Edition 4 2 Appendix COSMED srl Appendix...

Страница 122: ...120 148 REF C04717 02 91 Q NRG User Manual Edition 4 2 Appendix COSMED srl CE Declaration of Conformity...

Страница 123: ...2 kV 4 kV 8 kV 15 kV air Radiated RF EM fields IEC 61000 4 3 3V m before modulation 80 MHz 2 7 GHz 80 AM at 1 kHz Proximity fields from RF wireless communications equipment IEC 61000 4 3 See following...

Страница 124: ...m s in ISM bands 80 AM at 1 kHz Voltage dips IEC 61000 4 11 0 UT 0 5 cycle At 0 45 90 135 180 225 270 and 315 0 UT 1 cycle and 70 UT 25 30 cycles Single phase at 0 Voltage interruptions IEC 61000 4 11...

Страница 125: ...electrical equipment Test equipment and conditions The test equipment required to perform electrical safety tests is listed below Safety Analyzer Leakage CurrentTester conforming to IEC 62353 Refer to...

Страница 126: ...a patient or for compensation or alleviation of disease injury or disability Medical Electrical System Combination as specified by its manufacturer of items of equipment at least one of which is medic...

Страница 127: ...require multiple earth bond tests to validate the connections of additional metal accessible parts on the enclosure The test current is applied between the earth pin of the mains supply plug and any...

Страница 128: ...the enclosure or touch leakage Applied parts leakage shall be performed on both mains and battery power operating mode Enclosure leakage test mains power operating Applied Parts leakage test mains po...

Страница 129: ...ritten authorization from COSMED prior to the repair or alteration of any COSMED products Failure to obtain a written authorization will result in a void of the warranty The limited warranty shall not...

Страница 130: ...o not place Q NRG near heat sources Adequate ventilation should be maintained in the room the testing is performed Manufacturer s Information You may contact the manufacturer directly at the following...

Страница 131: ...n unit If you wish to purchase an optional module separately from the unit please contact our sales department or our distributor REF Description Notes C09092 X1 99 Q NRG CANOPY and MASK modes C09092...

Страница 132: ...l A 870 155 001 Regulator MET Mix w ISO5359 hose assembly C00600 02 11 Calibration Syringe 3 liters for Rest ing Low Flows C04833 01 20 Syringe Small adapter A 108 300 012 Corrugated tube for adapter...

Страница 133: ...meter Xsmall C03615 01 10 V2 Mask for RMR flowmeter Petite C03617 01 10 V2 Mask for RMR flowmeter Small C03618 01 10 V2 Mask for RMR flowmeter Medium C03619 01 10 V2 Mask for RMR flowmeter Large C0425...

Страница 134: ...OMNIA Metabolic Canopy module OMNIA Metabolic Mask module OMNIA Metabolic Vent module Disposables REF Description Image A 180 100 002 Q NRG Q NRG Sampling lines 100 pcs A 182 300 004 Antibacterial Fi...

Страница 135: ...690 02 10 Veils Single use for SMALL Canopy Hood 50 pcs Not available in US Via dei Pi a ni di Monte Savello 37 Albano Laziale 00041 Rome I T ALY Disposa ble Veil for Canopy Hood Large Reord er C0469...

Страница 136: ...NRG User Manual Edition 4 2 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 Pack...

Страница 137: ...conds WARNING AccessoryequipmentconnectedtotheQ NRG sdataportsmustbecertifiedaccordingtotheIEC60950 standard AllresultingcombinationsofequipmentmustbeincompliancewiththeIECstandard 60601 1systemsrequi...

Страница 138: ...ating Q NRG with Philips IntelliBridge Configuration is required to establish the communication between Q NRG and the Philips multiparameter monitors that support IntelliBridge 1 Connect Q NRG as desc...

Страница 139: ...P40 50 60 70 80 90 Software rev H 15 or higher discontinued Philips IntelliVue MX400 450 500 550 600 700 800 all software revisions Philips IntelliBridge System C 0 standalone discontinued Philips Int...

Страница 140: ...2015 Registration n 387 A Kiwa ISO 13485 2016 Registration n 387 M Kiwa Medical Device Directive CE mark MDD 93 42 EEC Notified Body 0476 Class IIa Expected device s life 7 years Applied parts Single...

Страница 141: ...hisequipmentgenerates usesandcanradiateradiofrequencyenergyand ifnotinstalledand usedinaccordancewiththeinstructions maycauseharmfulinterferencetoradiocommunications However thereisnoguaranteethatinte...

Страница 142: ...z 100 130VA Fuses 100 240V T3 15 AH 250V 2x Power Supply rechargeable battery Model A Model B Type Li Ion smart battery Li Ion smart battery Autonomy up to 3 hours up to 3 hours Nominal Capacity 3200m...

Страница 143: ...ISO 5356 1 Resistance 2 36 cmH2O s L 60 LPM Dead Space 21 mL TidalVolume Range 90 1500 mL FiO2 Adapter ConnectionType ISO 5356 1 Dead Space 12 mL InternalTurbine Flowmeter CANOPY Mode Flow REE Calibra...

Страница 144: ...ity Ventilation Mode Any modality that guarantee that measured inspiratory and expiratory volumes match patient s inhaled and exhaled volumes e g face mask with controlled leaks are not compatible wit...

Страница 145: ...nsed 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 ti sgx graphics sdk 5 01 01 02 licensed under the terms of the GPLv...

Страница 146: ...3 years of the date you received the GPL or LGPL covered code For your convenience some or all of the source code may also be found at https github com crosstool ng crosstool ng archive crosstool ng...

Страница 147: ...review J Am Diet Assoc 2006 106 881 903 Singer P Berger MM Van den Berghe G Biolo G Calder P Forbes A Griffiths R Kreyman G Leverve X Pichard C et al ESPEN Guidelines on Parenteral Nutrition intensiv...

Страница 148: ...146 148 REF C04717 02 91 Q NRG User Manual Edition 4 2 Appendix COSMED srl Notes...

Страница 149: ...147 148 REF C04717 02 91 Q NRG User Manual Edition 4 2 Appendix COSMED srl...

Страница 150: ...148 148 REF C04717 02 91 Q NRG User Manual Edition 4 2 Appendix COSMED srl...

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Страница 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...

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