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82 - Appendix - EMC



EMC

Guidance and manufacturer’s declaration - electromagnetic emissions

The device is intended for use in the environment below. User should not operate the system outside of this environment

Emissions test

Compliance

Electromagnetic environment – guidance

RF emissions

CISPR 11

Group 1

The 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

The device is suitable for use in all establishments,

except

domestic establishments and those

directly connected to the public low-voltage power supply network that supplies buildings
used for domestic purposes

Harmonic Emission

IEC 61000-3-2

Class A

Voltage Fluctuations /
Flicker Emission

IEC 61000-3-3

Complies

Содержание Quark CPET

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

Страница 2: ......

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 8: ......

Страница 9: ...Getting Started...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 25: ...Installation...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

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

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 43: ...System Cleaning Maintenance...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 83: ...Appendix...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 101: ......

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

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