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Quark User manual, XIII Edition

01/2018

COSMED Srl - Italy

http://www.cosmed.com

Part N. C03262-02-91

Summary of Contents for Quark CPET

Page 1: ...Manuale Utente User Manual Manuel d utilisation Benutzerhandbuch Manual del Usuario Quark PFT Quark CPET Quark SPIRO...

Page 2: ......

Page 3: ...mitted in any form without the expressed written permission of COSMED Srl Each copy of the COSMED Software can only be installed on one computer Excel is a registered trademark of Microsoft Corporatio...

Page 4: ...aindications 11 Contraindications for Exercise Testing 12 Absolute Contraindications 12 Relative Contraindications 12 Environmental Conditions for Operation 13 Overview 14 Introduction 15 System Overv...

Page 5: ...ROCC PNT 33 Connect the Quark to the computer PC 33 Power the Quark Unit when installed on the Optional Trolley 33 Prepare the Quark Unit and Subject for Exercise Testing 34 Prepare the Quark 34 Subje...

Page 6: ...Items 77 Sampling line maintenance Permapure 78 Equipment Inspection 79 Fuse Replacement 80 Appendix 81 EMC 82 Declaration of Conformity 86 Service Warranty 87 Warranty and limitation of liability 87...

Page 7: ...and VCO2 93 Anaerobic Threshold modified V Slope 93 References 93 Oxygen Kinetics 93 Predicted Sets 94 Automatic Diagnosis algorithm 95 Quality Control Messages 96 References 97 Spirometry 97 Dosimete...

Page 8: ......

Page 9: ...Getting Started...

Page 10: ...to improper use of this device Examples include Operation of the device by unqualified individuals Use of the device not indicated by this manual Not complying with the precautions and instructions de...

Page 11: ...SMED authorized personnel 4 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 lo...

Page 12: ...ccessoriessuppliedwiththeequipmentshouldbe usedwiththedevice Theuse ofany otheraccessories and or cables may result in increased emissions or decreased immunity of the equipment 15 Thedeviceshouldnotb...

Page 13: ...tests Hyperventilation syndrome Contraindications for Bronchial Provocation Testing Bronchial Provocation testing must be executed under the direction of a physician Testing is considered safe when e...

Page 14: ...xercise e g infection renal failure thyrotoxicosis Acute myocarditis or pericarditis Physical disability that would preclude safe and adequate test performance Inability to obtain consent Relative Con...

Page 15: ...ixtures 4 COSMED devices should be operated under normal environmental temperatures and conditions IEC 60601 1 EN 60601 1 Temperature 10 C 50 F and 40 C 104 F Relative humidity 30 to 90 not condensing...

Page 16: ...eps required to properly install the device 3 SystemCleaning Maintenance Describes system cleaning disinfection and routine maintenance procedures 4 Appendix Contains information regarding the warrant...

Page 17: ...ust be configured with either the turbine flowmeter or X 9 PNT Each module will allow the following tests to be performed Module Tests Available Spirometry FVC VC MVV Lung Volumes FRC via Nitorgen Was...

Page 18: ...Powering off the device Press the power switch on the front panel The green led above the switch will turn off indicating that the Quark is no longer powered on Flowmeter s Turbine Flowmeter The turb...

Page 19: ...ired to calibrate prior to each test It can be used for all spirometry tests Each X9 is shipped with an individualized linearization table It is necessary to load the table from the paired USB drive s...

Page 20: ...roper disinfection see the chapter System Cleaning Maintenance These blue masks are available in different sizes and should be assembled the included head cap as shown in the chapter Exercisetesting M...

Page 21: ...mple spirometry tests FVC VC and MVV The mouthpieces should not be used for any other testing Soft PTE Mouthpieces The soft PTE mouthpieces are available for all lung function tests other than spirome...

Page 22: ...g the transmitter and the USB receiver The parts should be near one another for the most effective communication signal Oximeter The oximeter probe should be placed on the patient s finger to measure...

Page 23: ...emixingchambermodalityinsteadofbreath by breath Dosimeter Thedosimeteriscomprisedofanebulizerandaccessoriesusedto deliverthebronchoprovocatorto thesubjectduring bronchoprovocationtests The package inc...

Page 24: ...g performed Below is a table displaying minimum warm up times based on each test Test Warm up Time mins FVC VC MVV FRC 5 CV 5 DLCO 15 MIP MEP P0 1 Oximetry ROCC CPET 5 RMR 5 During the warm up the dev...

Page 25: ...Installation...

Page 26: ...atedQuarkmodelwhichtheycanbeconfiguredforIfyou wish to purchase an optional module after the initial purchase please contact COSEMD sales department or your local distributor REF Description Available...

Page 27: ...006 1 Pressure regulator for O2 cylinder A 870 150 011 1 Pressure regulator for DLCO cylinder C03611 01 10 1 Mask VO2max Small C03612 01 10 1 Mask VO2max Medium C03613 01 10 1 Mask VO2max Large C0361...

Page 28: ...The following picture displays the correct assembly 1 Trolley 2 Trolley Top 3 Supply Drawer 4 Printer shelf 5 Accessory shelf 6 Gas Cylinders 7 Quark unit 8 Holder for breathing valve turbine etc 9 M...

Page 29: ...k Unit the required environmental conditions should be verified to be within the acceptable range for more information refer to the Environmental Conditions for Operation seciton Quark front panel 1 P...

Page 30: ...for PC Serial connectionto computer COM Port PFT SPIRO CPET 12 Temperature Relative Humidity Port Connection for Temperature and Humidity Probe external PFT SPIRO CPET 13 USB A port to PC USB connecti...

Page 31: ...ficatewhichindicatesactualgasconcentrations Install the gas regulators on the cylinder Secure the gas regulator on the cylinder as shown in the next following picture A new white washer should be plac...

Page 32: ...the regulator counter clockwise Note Toensurealongcylinderlife donotforcethevalvetoitsmaximumopeningoropenandcloserepeatedly Close thecylinderforashortperiodoftimebyrotatingtheneedlevalve tap attheend...

Page 33: ...9 3 Antibacterial filter Note inordertoobtainreliablemeasurements thePNTX9 mustbealwaysusedwiththeantibacterialfilter Attach the flowmeter to the handle Note Toobtainreliablemeasurements thePNTX9alway...

Page 34: ...ing valve and Demand valve Demand valve pneumatic connection is from S N 2014041001 6 Sampling Line Must be connected to connector 2 of the rear panel of the Quark Sampling 7 PNT X9 Pneumatic tubes fr...

Page 35: ...e trolley use a short cable and insert the power cable in the Quark rear panel 3 Connect the opposite end to the Trolley power strip located behind the drawer or on the vertical support 4 Repeat the a...

Page 36: ...RS232 port on the rear panel of the Quark or directly to the computer via COM port or USB to Serial adapter Ergometer must be selected prior to starting the test Note Cellularphonesshouldbeturnedoffto...

Page 37: ...he tapered end will correspond to the smaller connector of the turbine cable should be oriented down c Attachthewindshieldtotheturbineandrotate1 8turnsothatthesamplinglineportalignswiththecablefromthe...

Page 38: ...secured to the subject the best practice is to perform a leak test according to the following steps 1 Place palm of hand operator or subject over turbine connector of mask 2 Perform check a Masks wit...

Page 39: ...onto the elastic strap 2 Wet the electrode surfaces on the inside of the belt on either side of the transmitter with water contact lens solution electrode gel to improve conductivity 3 Adjust the str...

Page 40: ...smitterarenotwater proof Itisnecessarytopreventanyliquidsfrompenetrating theareaandavoidsubmergingtheelectrodesinliquid The electrodes should be placed as follows V1 4th intercostal space to the right...

Page 41: ...ests with ventilation values maintained at less than 100 L min it is possible to use a rubber mouthpiece anti bacterial filter and nose clip in place of the mask Assemble the mouthpiece filter and rea...

Page 42: ...or information COSMED S r l Via dei Piani di Monte Savello 37 00041 Pavona di Albano Rome ITALY Voice 39 06 931 5492 Fax 39 06 931 4580 email customersupport cosmed com Internet http www cosmed com Co...

Page 43: ...System Cleaning Maintenance...

Page 44: ...disinfected prior to first useAll materials used in the construction of the Quark and its accessories are nontoxic and pose no safety risks to the patient or operator The device should be powered off...

Page 45: ...or other diseases that are spread by droplet nuclei are likely to be encountered proper attention to environmental engineering controls such as ventilation air filtration or ultraviolet decontaminati...

Page 46: ...tory bodies All other components are classified as non critical The cleaning and disinfection procedure has been validated by an independent test laboratory Applicable parts when maintained properly a...

Page 47: ...r A sterile water rinse is recommended when available although tap potable water is also acceptable for use in cleaning COSMED components Maintenance Theappliedpartswhichhavebeen disassembled mustbere...

Page 48: ...46 System Cleaning Maintenance Spirometry Tests Spirometry Tests...

Page 49: ...er in excess from the item 3 Inspect all surfaces and item features to ensure that it is visibly clean repeat Manual Cleaning if not 1 Soak for 3 minutes in a mild detergent solution Cidezyme at room...

Page 50: ...e 3 minutes only scrub outside only 2 Wipe while rinsing for 5 minutes in a large volume of water Using a lint free towel or gauze remove the water in excess from the item 3 Inspect all surfaces and i...

Page 51: ...emove one Clinell Sporicidal wipe from the pack To activate wet the wipe with water under a tap or soak in a bucket Squeeze out the wipe to remove excess water Wipe the surface taking care not to go o...

Page 52: ...Soak for 3 minutes in a mild detergent solution Cidezyme at room temperature 22 C Using a soft bristle brush scrub the item submerged in the cleaning solution during the 3 minutes 2 Wipe while rinsing...

Page 53: ...the component in tap water at 22 40 C After disassembling the demand valve wipe any soil with a moist sponge or lint free towel Manual Cleaning 1 Soak for 3 minutes in a mild detergent solution Cidez...

Page 54: ...l Cleaning Wipe with a damp soft cloth Disinfection Wear recommended PPE Remove one Clinell Sporicidal wipe from the pack To activate wet the wipe with water underataporsoakinabucket Squeeze out the w...

Page 55: ...ng Maintenance Spirometry Tests 53 Disposable items Description Item When Note PTE soft mouthpieces After each test Antibacterial filter After each test Paper mouthpieces After each test Nose clips Af...

Page 56: ...54 System Cleaning Maintenance CPET RMR Tests CPET RMR Tests...

Page 57: ...ibly clean repeat Manual Cleaning if not 1 Soak for 3 minutes in a mild detergent solution Cidezyme at room temperature 22 C Using a soft bristle brush scrub the item submerged in the cleaning solutio...

Page 58: ...bly clean repeat Manual Cleaning if not 1 Soak for 3 minutes in a mild detergent solution Cidezyme at room temperature 22 C Using a soft bristlebrush scrubtheitemsubmergedinthecleaning solution during...

Page 59: ...lint free towel or gauze remove the water in excess from the item 3 Inspect all surfaces and item features to ensure that it is visibly clean repeat Manual Cleaning if not 1 Soak for 3 minutes in a mi...

Page 60: ...move one Clinell Sporicidal wipe from the pack To activate wet the wipe with water under a tap or soak in a bucket Squeeze out the wipe to remove excess water Wipe the surface taking care not to go ov...

Page 61: ...solution during the 3 minutes 2 Wipe while rinsing for 5 minutes in a large volume of water Using a lint free towel or gauze remove the water in excess from the item 3 Inspectallsurfacesanditemfeatur...

Page 62: ...60 System Cleaning Maintenance CPET RMR Tests Disposable Items Description Item When Note PTE soft mouthpieces After each test Antibacterial filter After each test Nose clips After each test...

Page 63: ...System Cleaning Maintenance Canopy test 61 Canopy test...

Page 64: ...et the wipe with water underataporsoakinabucket Squeeze out the wipe to remove excess water Wipe the surface taking care not to go over the same area twice Change wipe if it becomes dry or soiled andd...

Page 65: ...the water in excess from the item 6 Inspect all surfaces and item features to ensure that it is visibly clean repeat Manual Cleaning if not 7 Soak for 3 minutes in a mild detergent solution Cidezyme a...

Page 66: ...evice case When Daily Note Cleaning only Pretreatment Wipe soil with a moist sponge or lint free towel Manual Cleaning Wipe the device with a wet soft cloth Disinfection Not applicable not in contact...

Page 67: ...System Cleaning Maintenance Canopy test 65 Disposable Items Description Item When Note Antibacterial filter After each test Protects canopy hose and device from possible cross contamination...

Page 68: ...66 System Cleaning Maintenance Mixing Chamber Test Mixing Chamber Test...

Page 69: ...isibly clean repeat Manual Cleaning if not 1 Soak for 3 minutes in a mild detergent solution Cidezyme at room temperature 22 C Using a soft bristle brush scrub the item submerged in the cleaning solut...

Page 70: ...r 3 minutes in a mild detergent solution Cidezyme at room temperature 22 C Using a soft bristle brush scrub the item submerged in the cleaning solution during the 3 minutes 2 Wipe while rinsing for 5...

Page 71: ...sibly clean repeat Manual Cleaning if not 1 Soak for 3 minutes in a mild detergent solution Cidezyme at room temperature 22 C Using a soft bristle brush scrub the item submerged in the cleaning soluti...

Page 72: ...3 minutes in a mild detergent solution Cidezyme at room temperature 22 C Using a soft bristle brush scrub the item submerged in the cleaning solution during the 3 minutes 2 Wipe while rinsing for 5 m...

Page 73: ...t it is visibly clean repeat Manual Cleaning if not 1 Soak for 3 minutes in a mild detergent solution Cidezyme at room temperature 22 C Using a soft bristle brush scrub the item submerged in the clean...

Page 74: ...e wet the wipe with water under a tap or soak in a bucket Squeeze out the wipe to remove excess water Wipe the surface taking care not to go over the same area twice Change wipe if it becomes dry or s...

Page 75: ...edPPEaccordingtothe bottle Remove one Clinell Sporicidal wipe from the pack To activate wet the wipe with water under a tap or soak in a bucket Squeeze out the wipe to remove excess water Wipe the sur...

Page 76: ...74 System Cleaning Maintenance Mixing Chamber Test Disposable items Description Item When Note PTE soft mouthpieces After each test Nose clips After each test...

Page 77: ...System Cleaning Maintenance Rocc test 75 Rocc test...

Page 78: ...large volume of water Using a lint free towel or gauze remove the water in excess from the item 3 Inspectallsurfacesanditemfeaturestoensurethatitisvisiblyclean repeat Manual Cleaning if not Disinfect...

Page 79: ...System Cleaning Maintenance Rocc test 77 Disposable Items Description Item When Note PTE soft mouthpieces After each test Antibacterial filter After each test Nose clips After each test...

Page 80: ...ed or smoky environments Keep the sampling line in sealed plastic bag in a dark cool and dry place If saliva enters the tube it should be replaced immediately Periodically grease the O ring on the con...

Page 81: ...le parts should also be inspected The equipment should be turned off and adapters should be disconnected from the power supply when inspecting the materials The turbine and breathing circuits also nee...

Page 82: ...e fuses can be replaced by follow the following steps 1 Open the power supply cover using a screwdriver 2 Extract the fuse holder 3 Replace the damaged fuse s Note Ensurethattheappropriatefusesareused...

Page 83: ...Appendix...

Page 84: ...e device uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class A...

Page 85: ...5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Powerqualityfromthemainsshouldbecommercialorhospital quality Voltage dips short interruptions and voltage variations o...

Page 86: ...ngthsfromfixedRFtransmitters asdeterminedbyan electromagnetic site surveya should be less than the compliance level in each frequency rangeb Interference may occur in the vicinity of equipment marked...

Page 87: ...to 800 MHz d 1 17 P 800 MHz to 2 5 GHz d 2 33 P 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 70 3 70 7 38 100 11 70 11 70 23 33 For transmitters rated at a maximum output power not lis...

Page 88: ...nt complies with the essential requirements of the Annex I of the Medical Device Directive 93 42 EEC are classified in Class IIa their design manufacturing and final checks are performed according the...

Page 89: ...MED products Failure to obtain a written authorization will result in voiding the warranty Thelimitedwarrantyshallnotbeextended diminishedormodifiedbytherenderingsoftechnicalservicefromCOSMED sagentso...

Page 90: ...39 06 9314580 E mail customersupport cosmed it USA contact COSMED USA Inc 2211 North Elston Suite 305 Chicago IL 60614 USA Phone 1 773 645 8113 Fax 1 773 645 8116 email serviceusa cosmed com COSMED U...

Page 91: ...such as emailing commercial invoices e To provide information to the selected business partners needed to supply your service How your personal data is treated Your personal data will be stored in an...

Page 92: ...ed municipal waste Electronic equipment must be collected separately according to the European Directive 2012 19 UE Otherwise it can cause dangerous consequences for the environment and human health T...

Page 93: ...ments of the Standard IEC 68 2 Basic Environmental Testing Procedures IEC 68 2 27 Shock Peak acceleration 100g 980 m s2 Duration 6msecs Pulse shape Half sine IEC 68 2 6 Sinusoidal vibration Frequency...

Page 94: ...0 0 35 Accuracy 0 003 Resolution 0 001 Warm up time 15 min CH4 analyser Type Infrared Response time 200 ms Range 0 0 35 Accuracy 0 003 Resolution 0 001 Warm up time 15 min Humidity absorber Capillary...

Page 95: ...omponent is slightly less than 1 0 whereas the upper component has a slope greater than 1 0 The intercept of these two slopes is the LT or AT point as measured by gas exchange The increase in VCO2 mor...

Page 96: ...ol 123 p 659 664 1981 Spirometric Standard for healthy non smoking adults ARRD Vol 10 3 p 57 67 1971 Pereira Brazil Pereira CAC Barreto SP Sim es JG Pereira FWL Gerstler JG Nakatani J Valores de Refer...

Page 97: ...ndRelationshiptoAgeandSex AmericanReviewofRespiratoryDisease Volume 99 1969 Vincken W Ghezzo H Cosio MG 1987 Maximal static respiratory pressures in adults normal values and their relationship to dete...

Page 98: ...coughing 50 drop in the flow in first second Blow out longer FET100 6 sec Blow out more air Flow 0 2l s within 20 ml of FVC Blow out harder dPEF 10 Take a deeper breath dFVC 200ml and 5 best FVC Blow...

Page 99: ...att MaximalRespiratoryPressures NormalValuesandRelationshiptoAgeandSex AmericanReviewofRespiratoryDisease Volume 99 1969 Vincken W Ghezzo H Cosio MG 1987 Maximal static respiratory pressures in adults...

Page 100: ...Thomas L Petty ERJ 2004 23 932 646 ATS ERS Task force B R Celli W MacNee committee members Standard for the diagnosis and treatment of patients with COPD A summary of the ATS ERS position paper Canopy...

Page 101: ......

Page 102: ...www cosmed com COSMEDsrl ViadeiPianidiMonteSavello37 AlbanoLaziale Rome 00041ITALY O 3906931 5492 F 3906931 4580 info cosmed com cosmed com...

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