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Quark PFT Quark CPET Quark SPIRO

1. COSMED srl Headquarters Via dei Piani di Monte Savello 37 Albano Laziale Rome 00041 ITALY Phone 39 06 931 5492 Fax 39 06 931 4580 COSMED info cosmed com Pulmonary Function Equipment
2. Gutierrez Chile Gutierrez et Al Reference values for Chile population Knudson Morris and Bass The maximal Expiratory Flow Volume curve Knudson et al ARRD Vol 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 ncia para Espirometria em uma amostra da popula o brasileira adulta Jornal de Pneumologia 1992 18 10 22 Mallozi MC Valores de refer ncia para espirometria em criangas e adolescentes calculados a partir de uma amostra da cidade de S o Paulo Valores finais publicados em Pereira CAC Lemle A Algranti E Jansen JM Valen a LM Nery LE Mallozi M Gerbasi M Dias RM Zim W Consenso Brasileiro sobre Espirometria Jornal de Pneumologia 1996 22 105 164 Scalambrini Costa F Scueiri CEB Silva Jr WC Pereira CAC Nakatani J Valores de refer ncia para espirometria em uma amostra da popula o brasileira adulta da ra a negra J Pneumologia 1996 22 165 170 Neder JA Andreoni S Castelo Filho A Nery LE Reference values for lung function tests Static Volumes Brazilian Journal Medical and Biological Research 1999 32 703 17 Neder JA Andreoni S Lerario MC Nery LE Reference values for lung function tests Il Maximal respiratory pressures and voluntary ventilation Braz J Med Biol Res 1999 32 719 27 Thai Wanchai Dejsomritrutai Khun Nanta
3. o o o 76 Appendix Calculations references Predicted values ERS93 Standardized Lung Function Testing Official Statement of the European Respiratory Society The European Respiratory Journal Volume 6 Supplement 16 March 1993 Compilation of reference values for lung function measurements in children Ph H Quanjer J Stocks G Polgar M Wise J Karlberg G Borsboom ERJ 1989 2 Supp 4 184s 261s KNUDSON 83 Changes in the Normal Maximal Expiratory Flow Volume Curve with Growth and Anging J Knudson D Lebowitz J Holdberg B Burrows ARRD 1983 127 725 734 ITS Intermountain Thoracic Society Clinical Pulmonary Function Testing second edition 1984 pp 101 144 LAM A survey of ventilatory capacity in Chinese subjects in Hong Kong Lam Kwok Kwong Pang Shing et Al Annals of Human Biology 1982 vol 9 No 5 459 472 Multic ntrico de Barcelona Spirometric reference values from a Mediterranean population J Roca J Sanchis A Agusti Vidal F Segarra D Navajas R Rodriguez Roisin P Casan S Sans Bull Eur Physiopathol Respir 1986 22 217 224 Nhanes III Spirometric reference values from a sample of the general US population John L Hankinson John R Odencrantz and Kathleen B Fedan Am J Respir Critr Care Med 1999 159 1798 187 Pneumobil Brazil Valores extraidos do Programa Pneumobil Brasil para a Tese de Doutoramento do Dr Carlos Alberto de Castro Pereira Boehringer
4. a To place an order register a product request a service answer a survey enter a contest allow communication with us and to supply necessary authorities with the required information b To define your commercial profile c To use your commercial profile for marketing or advertising purposes d For necessary accounting procedures such as emailing commercial invoices e To provide information to the selected business partners needed to supply your service E How your personal data is treated Your personal data will be stored in an electronic format and protected against destruction loss unauthorized access or use not conforming to the purposes listed above H Consent The consent to treat your personal data is optional but if denied COSMED cannot supply the appropriate services H Holder of the personal data Personal data is held by Cosmed Srl Via dei Piani di Monte Savello 37 Pavona di Albano Laziale RM M Customer rights In accordance with Art 7 you may a Obtain confirmation of the existence and sharing of your personal data b Obtain information on the e updating correction or integration of your data e deletion or transformation of your personal data c Deny your consent to treatment of your personal data These rights can be exercised by a request in writing to the holder responsible for your personal data Appendix Privacy Information 71 1 Disposing of electrical equipment The device can
5. Quark PFT Quark CPET Quark SPIRO Manuale Utente User Manual Manuel d utilisation Benutzerhandbuch Manual del Usuario Y COSMED Pulmonary Function Equipment COSMED does not assume any liability for end user interpretation of this user manual or for casual or consequential damages in connection with the provision representation or use of this documentation No parts of this manual may be reproduced or transmitted 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 Corporation DBIII is a registered trademark of Bordland International Inc Lotus 123 is a registered trademark of Lotus Development Corporation Quark User manual XI Edition 06 2013 Copyright 2012 COSMED COSMED Srl Italy http www cosmed com Part N C03262 02 91 Table of contents Table olcontentsm eee e rr Getting stite dr ee a O LI IMPOrnant NOTICE ear 10 MERE ROOT A PR 10 Specific Indic tions TOr USE ee ee ee iaia 10 Description of the acronyms used in measured parametersS ieri 10 ME RR IRE INSERTI 11 El IRA 13 H Contraindications for the spirometry testing nina 13 Absolute COMTANS eon EE E ETE EE EE E EE E EEE EE 13 Relative contraindications ccccecccescccsecceecceseeceeeeseeeeeeeeseeeeeeeeeeeeeeeeeseeeseeeeseeeeeeeeseeeeeueeseuseeaseseusesaeeseu
6. BOSIO OE a aaa Ae AAA EE 80 UNEN Une E A RR PE A 80 SInele Breaih WIEN ABO nee Ra ocacion 80 S nele Breath without ANO rr iaa 80 PP e 2020 2008 ee 80 Resistance aaacasa 80 G s EXCNangeu elia ias 80 INAI CCt CRIGHIME aran dra 81 SUD MAXIMAL Exercise TESTINE nn laicale 81 eee 81 SIN OO NE RIM OR AIA SRO OT 81 Celle 81 Getting started Important notices E Intended use The COSMED Quark Series system is a modular system with multiple configurations allowing the following measurements Spirometry Lung Function Testing Cardiopulmonary Exercise Testing Resting Metabolism The system and its accessories are indicated for the acquisition analysis formatting display printing and storage of certain physiologic signals It is intended to assist a clinician in the diagnosis of cardio pulmonary disease conditions Caution Federal law restricts this device to be sold by the order of a physician The device must not be intended as a monitoring device nor as a sole means for determining a patients diagnosis but for the purpose of assisting the clinician in the diagnosis of cardio pulmonary diseases This equipment is intended to be used for the following applications e Formulating of a lung pathology diagnosis e Assisting with human physiology studies e Contributing to sports medicine applications COSMED Srl is not responsible for incidents which occur due to improper use of this device Examples include e Operation of t
7. DLCO Respiratory mechanics CPET Dosimeter O N Oximeter Airway resistances Nutritional Canopy Mixing Chamber O O Quark C12 O O M In the packaging O Optional The Quark Spiro and Quark PFT should be configured with either the turbine flowmeter or PNT Each module will allow the following tests to be performed Spirometry FVC VC and MVV Lung volumes FRC via Nitrogen Wash out and Closing Volume DLCO Diffusion capacity with or without apnoea or intra breath method Respiratory mechanics MIP MEP and PO 1 CPET Breath by breath exercise testing Dosimeter Allows measurements to be obtained after the delivery of broncho provocators according to standardized protocols Oximeter Oximetry tests Airway Resistance Airway Resistance via the interruption method Nutritional Canopy Resting Metabolic Rate Mixing Chamber Exercise testing using the mixing chamber technique ideal for sports medicine Quark C12 Incorporates the ECG during exercise testing Getting started Introduction 21 System overview The Quark consists of the following parts e Quark unit e Flowmeter e Breathing valve e Additional external sensors and devices temperature humidity HR oximeter E Quark unit The Quark unit contains the following elements e The power switch located on the
8. and is able to detect changes in airway caliber Description of the acronyms used in measured parameters Parameter Description PO 1 Respiratory Drive V Ventilation R Respiratory frequency Parameter Description FVC Forced Expiratory Vital Capacity FEV1 Forced Expiratory Volume in 1 sec FEF25 75 Mid expiratory flow between 25 75 of the FVC PEF Peak Expiratory Flow e F VCO Carbon Dioxide production MVV Maximum Voluntary Ventilation FRC Functional Residual Capacity 10 Getting started Important notices DLCO CO Diffusion Capacity SpO Hemoglobin saturation MIP Maximum inspiratory pressure MEP Maximum expiratory pressure E Warnings TGV Thoracic Gas Volume The device program algorithms and presentation of the measured data has been developed in accordance with the specifications outlined by the ATS American Thoracic Society and ERS European Respiratory Society Additional international references have also been applied where applicable All bibliography references are reported in the Appendix This User Manual has been developed in accordance with the Class Ila European Medical Device Directive requirements Warning To avoid risk of electric shocks this device must be connected to sockets with protective earth The precautions listed below should be noted before operating the device to ensure the safety of the user 1 This User Manual should always be available as a reference when testi
9. device should assure that it is used in such an environment Emissionstest Compliance Electromagnetic environment guidance RF emissions The device uses RF energy only for its internal function Therefore its RF CISPR 11 emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class B The device is suitable for use in all establishments including domestic CISPR 11 establishments and those directly connected to the public low voltage mer Class A power supply network that supplies buildings used for domestic purposes Voltage Fluctuations Complies Flicker Emission IEC 61000 3 3 16 Getting started EMC Guidance and manufacturer s declaration electromagnetic immunity The device is intended for use in the electromagnetic environment specified below The customer or the user of the device should assure that it is used in such an environment Immunity test Test level omens level Electromagnetic environment guidance IEC 60601 1 Electrostatic E kV contact 6 kV contact Floors should be wood concrete or ceramic tile If discharge ESD 8 kV air 8 kV air floors are covered with synthetic material the IEC 61000 4 2 relative humidity should be at least 30 2 kV for power Mains power quality should be that of a typical Electrical fast 2 kV for power transient burst supply lines supply lines commercial or hospi
10. 162 HE Prevention of infection transmission Transmission to technicians Prevention of infection transmission to technicians exposed to contaminated spirometer surfaces can be accomplished through proper hand washing and use of barrier devices such as suitable gloves To avoid technician exposure and cross contamination hands should be washed immediately after direct handling of mouthpieces tubing breathing valves or interior spirometer surfaces Gloves should be worn when handling potentially contaminated equipment if the technician has any open cuts or sores on his her hands Hands should always be washed between patients Cross contamination To avoid cross contamination reusable mouthpieces breathing tubes valves and manifolds should be disinfected regularly Mouthpieces nose clips and any other equipment that comes into direct contact with mucosal surfaces should be disinfected or if disposable discarded after each use Only the portion of the circuit through which rebreathing occurs must be decontaminated between patients or if disposable discarded after each use Disposable sensors when appropriately used avoid the need for decontamination of sensors and mouthpieces Tuberculosis In settings where tubercolosis 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 decontamination of air
11. 695 MIP MEP Leo F Black Robert E Hyatt Maximal Respiratory Pressures Normal Values and Relationship to Age and Sex American Review of Respiratory Disease Volume 99 1969 Vincken W Ghezzo H amp Cosio MG 1987 Maximal static respiratory pressures in adults normal values and their relationship to determinants of respiratory function Bull Eur Physiopathol Resp 23 435 439 E Automatic diagnosis algorithm Reference Lung Function Testing selection of reference values and interpretative strategies A R R D 144 1991 1202 1218 LLN Pred 0 674 SD ATS 50 percentile LLN Pred 1 647 SD ERS 95 percentile LLN Pred 0 8 80 Pred Message interpretation Criterion Normal spirometry FVC and FEV1 FVC gt LLN Obstructive abnormality may be physiological Pred FEV1 gt 100 Obstructive abnormality mild Pred FEV1 lt 100 and gt 70 Obstructive abnormality moderate Pred FEV1 lt 70 and gt 60 Obstructive abnormality moderately severe Pred FEV1 lt 60 and gt 50 Obstructive abnormality severe Pred FEV1 lt 50 and gt 34 Obstructive abnormality very severe Pred FEV1 lt 34 Restrictive abnormality mild FVC lt LLN and Pred FVC gt 70 Restrictive abnormality moderate Pred FVC lt 70 and gt 60 Restrictive abnormality moderately severe Pred FVC lt 60 and gt 50 Restrictive abnormality severe Pred FVC lt 50 and gt 34 Restrictive abnormality very severe Pred F
12. McConnell in ACSM s Resource Manual for Guidelines for Exercise Testing and Prescription a Edition pp 361 366 Franklin BA ed ACSM s Guidelines for Exercise Testing and Prescription 6 Edition Philadelphia Williams amp Wilkins 2000 22 29 Oximeter National Lung Health Education Program NLHEP Guide to prescribing Home Oxygen By 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 Energy Expenditure and Fuel Selection in Biological Systems The Theory and Practice of Calculations Based on Indirect Calorimetry and Tracer Methods M Elia G Livesey World Rev Nutr Diet Basel Karger 1992 vol 70 pp 68 131 Nutritional assessment in Critical Care a training handbook Donald C Zavala Exercise Physiology energy nutrition and human performance William D McArdle Frank I Katch Victor L Katch General ATS ERS TASK FORCE STANDARDISATION OF LUNG FUNCTION TESTING Edited by V Brusasco R Crapo and G Viegi General considerations for lung function testing Eur Respir J 2005 26 153 161 ATS ERS TASK FORCE STANDARDISATION OF LUNG FUNCTION TESTING Edited by V Brusasco R Crapo and G Viegi Interpretative strategies for lung function test Eur Respir J 2005 26 720 735 Appendix References 81 82 Appendix References WWW Cosmed com
13. O O O Coe ica iaia 69 H Warranty and limitation of liability ccecccccccccccccoccoccoccoccooooooocoocoococcoceocaecascsocescsocosescesoaecescescseceseseneuss 69 H Return goods policy for warranty or non warranty repair cscccsscccsscccscccscccssccnscccsscccscccescccscccescccscccescccssccenes 69 E Repair Service PONCY alari 69 PENNE IO FREIO PR ee AE 71 H Personal data treatment and purposes cssccssccssccscccsccssccnsccnsccssccscccscccsccnsccnsccsscnsccesccnsccescosscesccesscesssessonscoess 71 E How your personal data is treated en 71 o PR ERA 71 H Moore 71 Mg RR ee TR E I RR I rrr ert tre 71 Disposing of electrical Coni Me sia 72 UL PR EIA II 73 CR E 73 EN 73 seo A O a on o o 5 EEEE 73 oo o A e 73 Medical Device Directive CE Walk casas gi 73 TECHNICAL rca 74 FO VN OT roi EEEE A OE AE AE EAE A A 74 ON A A e oro PO O o 0 ee E 74 A A E en ee ee ee 74 CO ANA V261P licia ar 74 e PR LIE CO R Ain Sa ia A 74 Humidity E 011014 0 E poe OVA POCO 054550 o nn see a 74 POWEFSUPP A A Pe E A IA 74 Environmental SENSO Seo cia ota 75 Mo e CE EEE O e e o Ue E EA 75 A o A A tn 75 ACCUr acy E O a no taaan 75 Calculations E 76 As A 76 M Anaerobic Threshold modified V Slope ccscccsccssccsscccsccesccecccecccscccscccsccusccesccnccusccusscescceccsccesccusccesscescsescsecs 76 Reel 76 E Acca 76 Podi 77 N Automatic diagnosis docu 78 o I I ETA 78 RETIENE ccm 80 PIT irta 80
14. RH TA sensor Y gt TTL auxiliary input output USB connector HR probe connector Heir MO O O Refer to the instructions for use 12 Getting started Important notices Contraindications Performing forced expiratory manoeuvres involved in spirometry testing may be contraindicated in certain conditions H Contraindications for the spirometry testing Absolute contraindications For FVC VC and MVV tests Post operative thoracic surgery patients For FVC tests Severe instability of the airways patients with severe Emphysema Bronchial non specific marked hypersensitivity Severe gas exchange impairment total or partial respiratory insufficiency Relative contraindications For FVC tests Spontaneous post pneumothorax Arterial venous aneurysm Severe arterial hypertension Pregnant with complications in the 3 month For MVV tests Hyperventilation syndrome H Contraindications for Bronchial Provocation testing Bronchial Provocation testing must be executed under the direction of a physician Testing is considered safe when executed properly in a clinical setting but the following contraindications should be acknowledged prior to testing Absolute contraindications Severe bronchial obstruction decreased FEV in adults Recent myocardium infarct Recent cerebral vascular accident Known arterial aneurysm Incapacity for understanding the provocation test procedures and its implication
15. airway resistance European Respiratory Journal 1991 4 623 626 G Liistro D Stanescu D Rodenstein C Veriter Reassesment of interrupter technique for measuring flow resistance in human J Appl Physiol 67 3 933 937 1989 Gas Exchange On line computer analysis and breath by breath graphical display of exercise function tests Beaver Wasserman Whipp JAP 34 1 128 132 1973 Measurement and analysis of gas exchange during exercise using a programmable calculator Sue Hansen Blais Wasserman JAP 49 3 1980 456 461 Principles of exercise testing and interpretation 2nd edition Wasserman et Al 1994 Clinical Exercise Testing 3 edition Jones 1988 ERS task force on standardization of clinical exercise testing Clinical exercise testing with reference to lung disease indications standardization and interpretation strategies J Roca B Whipp S Anderson R Casaburi J E Cotes P Palange ERJ 1997 10 2662 2689 80 Appendix References Indirect Calorimetry Energy Expenditure and Fuel Selection in Biological Systems The Theory and Practice of Calculations Based on Indirect Calorimetry and Tracer Methods M Elia G Livesey World Rev Nutr Diet Basel Karger 1992 vol 70 pp 68 131 Nutritional Assessment in Critical Care A Training Handbook Donald C Zavala Sub maximal exercise testing Cardiorespiratory Assessment of Apparently Healthy Populations Timothy R
16. an ee ee ee ee 58 Reassembling the mask and components rei 58 H Cleaning esi pela 58 As nn PA 58 Disassembling the breathing ValVe cccccceccsccsecceccscesecesccseeseceeccseeseceuceseeneeseeeeceeeeeeeeceeeeeeeeeeeeeeeeeeeeeeeeeeeeres 58 Cleaning The breathing Vail 59 Disinfecting the breathing valve au I A DAE di 60 Reassembly the breathing valve sonia 60 H Cleaning and disinfecting the RMR canopy hood and veil option ccseccssccsseccsscccssccnscccssccscccescecssccesceees 60 Cleaning Nood and Velen re e o E AA 60 Disinfecting hood ananas otra een aan 60 H The mixing chamber option cleaning and CisinfectiOn cccssccsseccssccssscescccsscccseccescccscccescccescccscccescenscccesceees 60 Disassembling the mixing chamber ir eere eee eeree cera cer arena cena ean cena cen acer ren een er acena cena cera cena eenneeao 60 Cleaning the mixing chamber aa ata 61 Disinfectine the mixing Chamber en ee ee eisen engen 61 Reassembling the mixing chamber eee 61 H Two way non rebreathing valve mixing chamber option cleaning and disinfection cccssccssecsssccsseccesceees 61 H Cleaning and disinfecting the dosimeter NEDULIZEL ccssccssccssccssccsccssccssccssccssccscccsccnsccnsscnsccnsccsscesccesccscoescees 61 ROUNE CSS taa 62 ROLE Oe Eo o oo E O e e Ue UE OE E o 62 LI Sampling line Maintenance Permapure siria een 63 El IP an 64 O O O O
17. assembly H Breathing valve The breathing valve should be cleaned and disinfected every day Disinfection prior to every test is not necessary due to filtering during test maneuvers Disassembling the breathing valve gt 1 Remove the flowmeter from the breathing valve 58 System maintenance Cleaning and disinfecting 2 Remove the demand valve a from the breathing valve Unscrew the tube b 3 Remove the cover on the rear of the breathing valve by means of a coin 4 Remove the membrane paying attention to its orientation must not be replaced upside down Cleaning the breathing valve Follow the standard cleaning procedure reported above Do not immerse the demand valve in water System maintenance Cleaning and disinfecting 59 Disinfecting the breathing valve Disinfect the parts of the breathing valve following the instructions for turbine disinfection Note The demand valve cannot be disinfected Reassembly the breathing valve Re assemble the breathing valve repeating the steps described for disassembling in reverse order paying attention to the orientation of the membrane E Cleaning and disinfecting the RMR canopy hood and veil option Cleaning hood and veil The Canopy hood and the veil must be cleaned after every use by wiping with a soft cloth and a alcohol free solution Disinfecting hood and veil Disinfect the parts following the instructions for turbine disinfectio
18. contact the manifacturer 1 Determine the required soak temperature and time of the sterilant disinfectant and assure that these requirements are met 2 Activate the glutaraldehyde solution by mixing the components per the manufacturers instructions Use the concentration testing devices sold by the manufacture to determine that the solution is above the minimum effective concentration Pour the activated glutaraldehyde solution into an appropriate sized basin 4 Completely immerse the mask and components in the basin Assure that all channels and cavities are filled with disinfectant and that no air pockets remain within the components 5 Cover the disinfectant soaking basin with a tight fitting lid to minimize chemical vapor exposure Step 2 Rinsing Adequate rinsing must follow disinfection to remove all traces of the toxic residues of the disinfectant left on the mask and components Sterile water rinse is preferred over tap water Tap water may contain a variety of micro organisms which could recontaminate the components 1 Rinse 1 Fill a basin with 7 8 liters of water preferably sterile water Place the mask and components into the basin and thoroughly rinse all the components for a minimum of one minute Empty basin 2 Rinse 2 Fill a basin with 7 8 liters of water preferably sterile water Place the components into the basin and thoroughly rinse all the components for a minimum of one minute Empty basin Step 3 Hot
19. enlarged diminished or modified by the renderings of technical service from COSMED s agents or employees when the product is ordered or following the use of the product s H Return goods policy for warranty or non warranty repair Products shipped to COSMED for repair are subject to the following conditions 1 Products may only be returned upon receiving a receipt which includes the Service Return Number SRN from COSMED S r l 2 The SRN report and packing list should be placed on the outside of the package 3 Returned goods must be shipped with freight and insurance charges prepaid Collect shipments will not be accepted 4 The following list of products is not eligible for return unless proven defective Special order items Expendable products Products held over 30 days after the COSMED invoice date Used products not in the original shipping containers Goods which have been altered or abused in any way 5 The following parts are not covered by warranty Consumables Fragile glass or plastic parts Rechargeable batteries Damages due to inappropriate use of the device H Repair Service Policy Goods returned to seller for non warranty repair will be subject to conditions 1 2 3 4 Returned goods requiring customs documents Pro forma Invoice and Customs Paper should comply with the Italian law e The shipment must qualify as a temporary export e Any goods returned to COSMED without customs papers will n
20. front panel e Connectors located on the rear panel Powering on the device When the unit is plugged in press the power switch on the front panel The green led above the switch will turn on indicating that the Quark is on 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 running E The flowmeter Turbine flowmeter The turbine flowmeter assembly consists of a bidirectional turbine and an optoelectronic reader The reader measures infrared light interruptions caused by the spinning blade inside the turbine The device may be used to measure a wide flow range and is not affected by ambient conditions pressure humidity room temperature exhaled gas composition Daily calibration of the turbine is not necessary but calibrations should be performed regularly to assure accurate measurements There are three turbine flowmeters 1D28 ID28 Spiro and ID18 22 Getting started System overview En Sun A The ID28 flowmeter can be used for all tests except for RMR testing and is provided with the Quark PFT and Quark CPET modules VO max VO max The ID28 flowmeter is identical to the ID28 with the absence of a sampling line This flowmeter should only be used for spirometry testing when exhaled flow gas analysis is not necessary This flowmeter is provided with the Quark Spiro module Shy Su 4 gh li The ID18 fl
21. gloves masks eye protection gowns will minimize the potential for personal exposure to blood borne and other disease producing organisms 3 Immediately separate and contain soiled reusable devices at the point of use and transport to the decontamination area so as to minimize risk of personal contact with contaminants 4 A disinfectant solution is only effective if it can contact all surfaces of the items to be disinfected or sterilized 5 Adequate ventilation is required in the disinfection area to evacuate the chemical vapors from glutaraldehyde if used Use lidded containers for the disinfectant solution when appropriate The inhalation of fumes from disinfectant solutions or skin contact with liquid disinfectants can be hazardous to personnel Warning Particular precautions should be taken when testing patients with high risk communicable diseases i e Tuberculosis Multidrug Resistant Staphylococcus infections etc When such conditions are present the clinical need for performing the test should justify the risks When performing the disinfection e Do not use alcohol or other liquids containing Gluteraldehyde on the exterior surface of the equipment e Do not use abrasive powders or glass cleaners containing alcohol or ammonia on the plexiglas component mixing chamber or canopy of the equipment e Do not steam autoclave any component other then rubber reusable masks plastic adapter and clips should be removed H In
22. should be used to prevent disease transmission Haemoptysis and oral lesions Special precautions should be taken when testing patients with haemoptysis open sores on the oral mucosa or bleeding gums Tubing and breathing valves should be decontaminated before reuse and internal spirometer surfaces should be decontaminated with accepted disinfectants for blood transmissible agents Other known transmissible infectious diseases Extra precautions should be taken for patients with known transmissible infectious diseases Possible precautions include the following 1 reserving equipment for the sole purpose of testing infected patients 2 testing such patients at the end of the day to allow time for spirometer disassembly and disinfection and 3 testing patients in their own rooms with adequate ventilation and appropriate protection for the technician Disposable in line filters These may be an effective and less expensive method of preventing equipment contamination The use of in line filters does not eliminate the need for regular cleaning and decontamination of lung function equipment H Other precautions and warnings Please take the following precautions during the cleaning and disinfection activities 1 The responsibility for handling cleaning and decontaminating reusable medical devices should be assigned to trained qualified individuals System maintenance Cleaning and disinfecting 53 2 Appropriate protective clothing
23. the ATS Board of Directors July 1999 Lung Volumes ATS ERS TASK FORCE STANDARDISATION OF LUNG FUNCTION TESTING Edited by V Brusasco R Crapo and G Viegi Standardisation of the measurement of lung volumes Eur Respir J 2005 26 511 522 Single Breath with Apnoea ATS ERS TASK FORCE STANDARDISATION OF LUNG FUNCTION TESTING Edited by V Brusasco R Crapo and G Viegi Standardisation of the single breath determination of carbon monoxide uptake in the lung Eur Respir J 2005 26 720 735 Single Breath without Apnoea Rest and Exercise Cardiac Output and Diffusing Capacity Assessed By a Single Slow Exhalation of Methane Acetylene and Carbon Monoxide Ramage Coleman and Macintyre CHEST 92 1 July 1987 MIP MEP Leo F Black Robert E Hyatt Maximal Respiratory Pressures Normal Values and Relationship to Age and Sex American Review of Respiratory Disease Volume 99 1969 Vincken W Ghezzo H amp Cosio MG 1987 Maximal static respiratory pressures in adults normal values and their relationship to determinants of respiratory function Bull Eur Physiopathol Resp 23 435 439 PO 1 G B Drummond J Fischer A Zidulka J Milic Emili Pattern of Reduction of Ventilatory and Occlusion Pressure Response to Carbon Dioxide by Pentazocine in Man Br J Anaesth 1982 54 87 96 Resistance P J Chowienczyk C P Lawson S lane R Johnson N Wilson M Silverman G M Cochrane A flow interruption device for measurement of
24. 0 90 psi Cylinders should be replaced when the internal pressure falls below 10 bars 150 psi Caution You should always close the cylinder and the gas regulator before disconnecting the hoses from the Quark H Assembling the breathing valve and the flowmeter vida 1 Breathing valve 2 Turbine 3 Antibacterial filter Align the sampling line onto the turbine with the tooth on the smart valve Installation Quark installation 43 q HAU 1 Breathing valve 2 PNT E Assembling the flowmeter to the handle 4 with turbine with Flowsafe gt with PNT X9 Handle Turbine ID28 Flowsafe Antibacterial filter ee NN ONO PNT X9 Note in order to obtain reliable measurements the PNT X9 must be always used with the antibacterial filter 44 Installation Quark installation E Assembling the VO max mask and the flowmeter 1 Occlusion valve 2 Reader 3 PNT M Connecting the Quark to the PC Connect the Quark unit to the PC through the RS232 or USB port by connecting the cable RS232 or USB to the proper COM or USB Quark and PC ports M Connecting the Quark to the power supply through the trolley 1 Connect the Quark unit to the trolley through the power cable 2 Connect the PC monitor and printer to the trolley through their power supply cables 3 Connect the trolley to the wall through its power cable The trolley has a separate switch on the back of the cart Warning Always turn off th
25. Dimensions 16x33x41 cm Weight 11 Kg weight depends on the configuration Oximeter Arms 70 100 1 70 Arms 60 70 2 16 Arms 70 80 1 90 Arms 80 90 1 80 Arms 90 100 1 34 Sao Accuracy specifications FVC FEV1 FEF25 75 PEF MVV FRC DLCO MIP MEP PO 1 SpO Ve RF HR VO VCO 3 5 or 0 100L s whichever is greater 3 5 or 0 100L s whichever is greater 5 5 or 0 250L s whichever is greater 7 or 0 420 L s whichever is greater 10 5 or 20 L min whichever is greater 5 5 3 5 or 0 5 cmH 0 whichever is greater 1 3 3 2 units 3 3 Appendix Technical features 75 Calculations references H VO and VCO Energy Expenditure and Fuel Selection in Biological Systems The Theory and Practice of Calculations Based on Indirect Calorimetry and Tracer Methods M Elia G Livesey World Rev Nutr Diet Basel Karger 1992 vol 70 pp 68 131 Nutritional Assessment in Critical Care A Training Handbook Donald C Zavala H Anaerobic Threshold modified V Slope The intercept of the two slopes is defined as the VO2 above which VCO2 increases faster than VO2 without hyperventilation and can be selected automatically or manually by the software During incremental exercise above the Lactate Threshold a net increase in lactic acid production results in an accelerated rate in VCO2 relative to VO2 When plotting these variables against each other a linear
26. Maranetra Kittipong Maneechotesuwan Nitipatana Chierakul Jamsk Tscheikuna Tasneeya Suthamsmai Arth Nana Benjamas Chuaychoo Phunsup Wongsurakiat Suchai Charoenratanakul Wilawan Juengprasert Chana Naruman Reference Spirometric Values for Healthy Lifetime Nonsmokers in Thailand J Med Assoc May 2000 83 457 466 DLCO Standardized Lung Function Testing Official Statement of the European Respiratory Society The European Respiratory Journal Volume 6 Supplement 16 March 1993 Appendix Predicted values 77 Compilation of reference values for lung function measurements in children Ph H Quanjer J Stocks G Polgar M Wise J Karlberg G Borsboom ERJ 1989 2 Supp 4 184s 261s Reference Values for Residual Volume Functional Residual Capacity and Total Lung Capacity ATS workshop on Lung Volume measurements official statement of the European Respiratory Society J Stocks Ph H Quanjer ERJ 1995 8 492 506 Single Breath Oxygen Test Buist SA Ross BB Quantitative Analysis of the Alveolar Plateau in the Diagnosis of Early Airway Obstruction ARRD 108 1081 1973 Mansell A Bryan C Levison H Airway Closure in Children JAP 33 711 714 1972 Buist SA Ross BB Predicted Values for Closing Volumes Using a Modified Single Breath Test ARRD 107 744 751 1973 Rint Lombardi E Sly PD Concutelli G et al Reference values of interrupter respiratory resistance in healthy preschool white children Thorax 2001 56 691
27. Service Warranty E Warranty and limitation of liability COSMED provides a one year limited warranty from the date of the original sale of the product COSMED products are guaranteed to be free from defect upon shipment 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 COSMED is promptly notified in writing by the buyer upon the discovery of defect 2 The defective product is returned to COSMED with transportation charges prepaid by the buyer 3 The defective product is received by COSMED no later than four weeks after the last day of the one year warranty period 4 COSMED s examination of the defective product verifies that the defect was not caused by misuse neglect improper installation or an unauthorized repair or alteration If the product is manufactured by a third party the warranties provided by the third party manufacturer will be the only ones available for the buyer COSMED hereby disclaims any warranties or liabilities arising from defects or damages to and or caused by products manufactured by a third party The buyer must obtain written 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 be
28. VC lt 34 M Quality Control Messages Reference Spirometry in the Lung Health Study Methods and Quality Control ARRD 1991 143 1215 1223 Message Criterion Start faster VEXT gt 5 of the FVC and gt 150ml Blast out harder PEFT gt 120 msec Avoid coughing 50 drop in the flow in first second Blow out longer FET100 lt 6 sec Blow out more air Flow gt 0 21 s within 20 ml of FVC 78 Appendix Predicted values Blow out harder Take a deeper breath Blow out faster That was a good test FVC reproducible FEV1 reproducible PEF reproducible MVV time too short dPEF lt 10 dFVC lt 200ml and 5 best FVC dFEV1 lt 200ml and 5 FEV1 No errors Diff 2 max FVC within 0 2 Diff 2 max FEV1 within 0 2 Diff 2 max PEF within 10 MVV time less than 12 sec Appendix Predicted values 79 References Spirometry ATS ERS TASK FORCE STANDARDISATION OF LUNG FUNCTION TESTING Edited by V Brusasco R Crapo and G Viegi Standardisation of spirometry Eur Respir J 2005 26 319 338 Lung function J E Cotes Blackwell scientific publications Guidelines for Clinical Exercises Testing Laboratories I L Pina G J Balady P Hanson A J Labovitz D W Madonna J Myers American Heart Association 1995 91 912 Dosimeter Guidelines for Methacholine and Exercise Challenge Testing 1999 Am J Respir Crit Care Med Volume 161 Number 1 January 2000 309 329 Official Statement of the ATS adopted by
29. aced 3 Visually inspect all metal components for corrosion Replace any metal components showing rust or chipped plated surfaces System maintenance Cleaning and disinfecting 57 Sterilizing the mask Sterilization of the silicone rubber face masks can be achieved with steam sterilization Warning Sterilization can be performed on the rubber mask only Do not apply sterilization on other parts Type of Cycle Gravity Displacement Type of Load Wrapped Method Temperature 132 135 c Cycle Time 10 15 minutes Special Notes 1 Follow cleaning procedures as instructed prior to steam sterilization Since the degree of sterility assurance depends on the amount of contamination of items to be sterilized thorough cleaning procedures are essential 2 All lubricants should be removed from components because this will interfere with steam contact Dry devices components reduce the potential for wet device packs after sterilization 4 Sterilization container systems should be cleaned after each use Reassembling the mask and components Reassemble mask and components Use appropriate personal protective clothing to assure that you do not recontaminate the components H Cleaning the headcap assembly Clean the head cap assembly with strap clips by hand washing with a mild detergent Do not use bleach Remove the head cap from the mask leaving the strap clips attached to the straps Machine or line dry Do not iron the head cap
30. apter 14 Getting started Contraindications Environmental condition of use COSMED units should not be operated near explosive substances Equipment 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 COSMED devices are not AP or APG units according to EN 60601 1 and should never be operated in the presence of flammable anaesthetic mixtures COSMED equipment should be operated under normal environmental temperatures and conditions which are defined as follows IEC 60601 1 EN 60601 1 e Temperatures range 10 C 50 F and 40 C 104 F e Relative humidity range 30 to 90 not condensing e Atmospheric Pressure range 600 mBar to 1060 mBar e Avoid operating equipment in the presence of noxious fumes or in dusty environments e Do not place units near heat sources e Cardiopulmonary resuscitation equipment should be accessible in the case of an emergency e Adequate floor space and easy access to the patient during exercise testing is necessary e Adequate ventilation should be maintained in the room the testing is performed Getting started Environmental condition of use 15 i EMC Guidance and manufacturer s declaration electromagnetic emissions The device is intended for use in the electromagnetic environment specified below The customer or the user of the
31. armed up for the required amount of time The warm up time duration depends on which test is being performed The following table displays the warm up time required for each test Test Warm up time mins FVC VC MVV CV DLCO MIP MEP PO 1 Oximetry Rocc CPET RMR During the warm up period the device must be powered on but the software does not need to be open Calibration and or testing procedures should never be performed until the warm up period has been completed Getting started System warm up 29 Installation Before starting Before operating the Quark you should inspect the equipment and complete the product registration H Checking the packing contents When opening your product you should assure that the package contains all items listed below If there are any missing or damaged parts you should contact Cosmed s technical assistance Note Actual packaging of device and modules could differ from the one specified below depending on the actual device s configuration H Device packaging Quark Spiro standard packaging Code Quantity Description C03262 02 91 User Manual 1 C03939 02 91 1 Software manual Quark PFT standard packaging Code Quantity Description Quark CPET standard packaging Code Quantity Description 32 Installation Before starting A 182 300 004 5 Antibacterial filters 1 C03262 02 91 C03939 02 91 1 Software manual User Manual E Packaging
32. ce and the patient for exercise testing sccccsssceccsssssccssscccssssccccecsccccscscscccscecccsseececscecsecsces 46 ME RR RE E E EI 46 A a 46 ligero AUN E E PO O suaty e er 46 AP e E o O ru O EA 46 EEG PICOS ran 47 Using a mouthpiece instead of a face MaSk ie 48 O Howtocontact COSWIED aca aaa 48 Complaints feedback and suggestionS rie 49 System maintenancem OE E PP A E 52 O Cleaning and dente std 53 H Prevention of infection transmission urinaria ias 53 Transmission to CINICO 53 Cross Conama ee een 53 TUE et 53 H emoptysis and Oral 06 01 ei 53 Other known transmissible infectious diseaSeS rena rerencera rena eeaa cena eran renan erancerancenanera 53 Disposable Miine TER a a a io a O aa 53 H Other precautions and WANESSA UAA Een dinis oriana 53 Ebit 54 di calici aa 54 Ceinec AlE a A N aaa 54 Standard clean ima podere ea 55 AM ee ta ide A E E E E N iaa 55 Preparing the disinfecting solution acia 55 E Theturbine TONO nai 56 Enne NE UDINE ee E E AA AAO ERA R 56 Done eE E ee o 56 Precautions to take when cleaning disinfecting and drying the turbine oocccocccoccncncnnonononcnnoncnnnnononcnnnnnnnos 56 o O UP E o E 56 H VO max mask and mixing chamber mask sccssccssccssscssccssccssccssccssccssccscccsccnsccnccesscesccnsccesccnsccssccsscesscssoescees 56 Disassembline DEM AK ee ENTE 56 Gemine A ye e o 57 A A o AI e O o E A 57
33. ded or smoky environments Keep the sampling line in sealed plastic bag in a dark cool and dry place e If saliva enters the tube it should be replaced immediately e Periodically grease the O ring on the connector to ease fitting to optical flowmeter e Replace the sampling line every 100 exercise tests or 200 PFT test or every 6 months In any case sampling line will become discoloured brown with age and may cause calibration to fail Note ALWAYS replace sample line as the first step in troubleshooting a failed gas calibration System maintenance Sampling line maintenance Permapure 63 _ Inspections The equipment requires inspections to be carried out to assure proper electrical and mechanical safety levels The inspections are recommended after extensive use of the equipment or after a long period of storage in unfavourable environmental conditions The insulation materials of cables plugs and any other visible 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 need to be inspected To inspect the turbine perform the following procedure e Verify by inspection that the turbine axis fits correctly and the blade is fastened on the axis you can lightly shake the turbine to note any anomalous movement e Assure that there are no torn or broken components in the breathing circui
34. dio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above the device should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the device b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 18 Getting started EMC Recommended separation distances between portable and mobile RF communications equipment and the device The device is intended for use in an environment in which radiated RF disturbances are controlled The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the device as recommended below according to the maximum output power of the communications equipment Rated maximum Separation distance tie to frequency of transmitter output power of E AO 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 17 VP d 1 17 VP Pr A E E I For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be determined using the equation appl
35. dirt should be removed and the cylinder should not be used if oil or grease is present 6 You should ensure that the pressure regulator is chemically and physically compatible with the intended gas cylinder before installation The regulator must be properly connected Note the pressure gauge for the regulator The physical condition of the regulator threads and fittings should also be examined prior to installation Any dust or dirt on the regulator or cylinder valve should be removed with a clean cloth The regulator should not be installed on a cylinder valve if grease or oil is present 7 After connecting the regulator to the cylinder you should increase the regulator output pressure to the recommended value 5 6 bars 70 90 psi 8 The cylinder and pressure regulator must be closed before disconnecting the cylinder from the device Residue and other contaminants in the breathing circuit pose a safety risk to the patient during testing procedures Aspiration of contaminants can be potentially life threatening If the recommended disposable anti bacterial filters are not used you must disinfect each part coming into contact with the patient and patient s breath prior to each test 10 The cleaning procedures and inspections in the System Maintenance section should be performed prior to each test 11 This device should not be used in the presence of flammable anaesthetics This is not an AP or APG device according to the EN 60 601 1 definit
36. e Rinse the turbine in a vessel filled of clean water shaking gently to remove the disinfectant Do not place the turbine under running water or move the turbine while submerged For cleaning and rinsing do not wet the sampling line Use the brush point 1 step 5 only for the external parts of the turbine in order to avoid damages to the turbine blade Disinfecting the turbine 1 Disconnect the sampling tube from the reader 2 Plunge the reader in a vessel containing the disinfectant solution for 20 minutes see picture below assuring that the sampling tube is not exposed to the solution the optical flowmeter and cable are waterproof NO OK 3 Rinse the turbine in a vessel filled with water and shake gently to remove the disinfectant do not place the turbine under running water or move the turbine while submerged 4 Allow the turbine to air dry 12 hours recommended depending on environmental conditions 5 After cleaning the turbine always calibrate prior to subsequent testing Precautions to take when cleaning disinfecting and drying the turbine e Do not expose the turbine to high heat or to a direct flow of water e Do not expose the sampling tube or the connector on the end of the cable to any liquids e Do not use alcoholic solutions to clean the turbine E PNT X9 For cleaning and disinfecting the PNT X9 follow the same instructions as for the turbine being careful to observe the following e Use distill
37. e trolley and the Quark when not in use Installation Quark installation 45 i Preparing the device and the patient for exercise testing H Preparing the Quark Connect the head cap the VO max mask and the ID28 turbine as shown in the following picture The head cap and mask can be connected by the white clips The turbine and HR probe should be connected to the rear panel of the Quark If you choose to drive an ergometer with the Quark connect the ergometer cable to the RS232 port on the rear panel of the Quark with the serial port provided in the packaging Select the ergometer to be used before starting the test Note Cellular phones should be turned off to eliminate potential electrical interferences H Patient preparation The mask Fix the mask as illustrated in the picture below Adjust the elastic bands on the head cap as necessary to eliminate possible leaks and create a tight seal around the subject s face The HR elastic belt To assemble the HR belt 1 Attach the Transmitter to the elastic strap 46 Installation Preparing the device and the patient for exercise testing 2 3 4 Adjust the strap to fit tightly and comfortably around the subject s thorax Secure the strap tightly around the chest below the nipple line and lock the buckle You may wet the grooved electrode areas with saliva contact lens solution or an alternative saline solution to help it stick to the subject The tran
38. ed water for preparing the disinfectant solution otherwise the calcium deposit could damage the flowmeter net e Do not dry the PNT X9 with hot air which may damage the flowmeter net E VO max mask and mixing chamber mask The face masks adapters and other components should be cleaned and disinfected prior to every test Sterilization can optionally be performed on the rubber mask only High level disinfection of mask and components ensures patient safety and minimizes the risk of infection Disassembling the mask Remove the round black turbine adapter held within mask and the clips that hold the headcap in place 56 System maintenance Cleaning and disinfecting Cleaning the mask Follow the standard cleaning procedure reported above Disinfecting the mask Step 1 Disinfection Use only liquid glutaraldehyde disinfectant solutions approved as sterilants disinfectants by the National Authority Warnings The fumes of glutaraldehyde can irritate the mucous membranes of eyes nose and throat Some people develop allergic reactions to glutaraldehyde that can cause skin rashes headaches and breathing difficulties Containers of glutaraldehyde should be kept closed and in a well ventilated area Gloves should be worn made of butyl or nitile rubber Do not use latex rubber gloves The concentration of glutaraldehyde in the air should not exceed 0 2 ppm For emergency safety or technical information about the glutaraldehyde solution
39. egulator has been chosen for the cylinder in use The gas regulator has an adjustable second stage that must be adjusted when used for the first time This is necessary to protect the internal demand valve from the high pressure generated when the cylinder is opened Connecting the hoses to the cylinders Note the following table in order to find the appropriate coloured hose for the cylinder in use the colour represents the different connectors used at the end of the hose Cylinder Connector colour Calibration Blue DLCO Green Oxygen White 42 Installation Quark installation Connecting the cylinders to the Quark It Warning The pressure knobs must be closed before connecting the cylinders to the Quark turn counter clockwise 1 Connectthe cylinders to the Quark making sure to match the appropriate coloured connectors 2 Assure that the pressure adjustment knob is closed by turning it counter clockwise 3 Open the cylinder by turning the valve on the top of the cylinder counter clockwise and the tap under the gas regulator counter clockwise Note To ensure a long cylinder life you should not force the valve to its maximum opening and you should avoid opening and closing the valve repeatedly To close the cylinder for a short period of time you may simply close the black tap under the gas regulator 4 Turn the pressure adjustment knob clockwise and adjust the pressure between 5 and 6 bars 7
40. essure line respiratory mechanics C00269 01 20 5 PTE ID25mm soft mouthpieces CPET Module standard packaging Code Quantity Description C03400 01 04 ID28 turbine C03611 01 10 Mask VO max Small C03612 01 10 Mask VO max Medium C03613 01 10 Mask VO max Large A 800 900 022 Head cap for the adult masks L A 800 900 023 Head cap for the adult masks S M C02210 02 08 Permapure sample line 2m 34 Installation Before starting C03564 01 10 C02500 02 04 A 661 200 071 A 661 200 070 A 661 200 039 A 362 315 010 C03309 01 12 C01790 01 36 Ergo hose ID18 turbine Elastic belt HR monitor HR receiver USB extension cable PFT input output HR TTL cable PC software CPET Oximeter module standard packaging Code Quantity A 661 600 007 1 Description Oximeter Airway Resistances module standard packaging Code Quantity C02410 02 04 1 C02420 01 08 A 182 300 004 C00311 01 20 A 662 100 001 Description Rocc Unit PNT Rocc Antibacterial filters Silicone hose Nose clips Nutritional module standard packaging Code Quantity C02500 01 04 1 C03880 01 10 1 C02678 01 07 C03886 01 10 C00965 01 04 A 182 300 004 C03729 01 30 A 182 300 004 C00269 01 20 A 662 100 001 C01788 01 36 C01790 01 36 Description ID18 turbine Quark RMR bubblehood Canopy wrinkled tube Canopy vail Canopy unit Antibacterial filter Canopy power supply Antibacterial filter Soft mouthpiece PTE ID25mm Nose clip PC S
41. he device by unqualified individuals e Use of the device not indicated by this manual e Not complying with the precautions and instructions described in this manual Specific Indications for use Device Indication for use Major clinical conditions Measured parameters model Quark SPIRO Pulmonary Function testing Age 6 Spontaneously breathing FVC FEV1 FEF25 75 PEF to adults patients healthy or affected by MVV SpO respiratory diseases such as asthma or COPD age 6 to adults asthma or COPD VCO TGV Quark CPET Pulmonary Function testing Age 6 Spontaneously breathing FVC FEV1 FEF25 75 PEF to adults patients healthy or affected by MVV VO VCO Ve RF HR Cardiopulmonary Exercise testing diseases limiting exercise spo Quark PFT Pulmonary Function testing Age 6 Spontaneously breathing FVC FEV1 FEF25 75 PEF to adults patients healthy or affected by MVV FRC DLCO MIP MEP Cardiopulmonary Exercise testing respiratory diseases such as PO 1 SpO Ve RF HR VO age 6 to adults tolerance Quark SPIRO and Quark PFT also allows the Airways Resistance Test through the interruption technique Rocc test for young patients from 3 to 6 years old Rocc technique was specifically developed for young non cooperative children not able to perform the spirometric maneuvers The interrupter technique is feasible and repeatable in preschool children has a good correlation with gold standard techniques
42. ial filters is recommended even when using disposable mouthpieces to prevent cross contamination H Nose clips Nose clips should be used during spirometry testing to prevent respiration through the nasal passage while performing testing manoeuvres H The HR probe The HR probe consists of three parts the elastic belt containing the transmitter and the USB receiver The parts should be assembled as close as possible to one another to acquire the most effective communication signal E The oximeter N 26 Getting started System overview The oximeter probe should be placed on the patient s finger to measure oxygen saturation at rest or during exercise H The Rocc PNT The Roc PNT allows the measurement of airway resistance by implementing the interruption technique E The mixing chamber The mixing chamber is a 8 7 litres plexiglas box for exercise or resting tests with the classic mixing chamber technique instead of the breath by breath one E The dosimeter Getting started System overview 27 The dosimeter is made of a nebulizer and accessories for the bronchoprovocator to be given to the patient for bronchoprovocation tests Its packaging includes the nebulizer a tubing for the Quark connection a mouthpiece and different adapters Its use is described in the chapter The dosimeter 28 Getting started System overview System warm up Before using the Quark the system must be w
43. icable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Notes 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Getting started EMC 19 1 Overview of the manual This manual is organized in the following chapters Getting started Describes the intended use of the device how to properly use it and features of the unit and accessories Installation Lists the steps required to properly install the device System maintenance Describes system maintenance procedures Appendix Contains information regarding the warranty treatment of personal data reference standards technical features predicted values and bibliographic references Software and test execution are described in the Software Manual We recommend to read both manuals before using this device 20 Getting started Overview of the manual Introduction The Quark is the designed for evaluation of the cardiorespiratory system The system can perform spirometry lung volumes diffusion or exercise testing The Quark can be configured with the following modules according to the user s needs Quark Spiro Quark PFT Quark CPET Spirometry M O Lung volumes
44. ion 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 High level disinfection is the recommended decontamination procedure for semi critical devices Devices are classified semi critical when they touches mucous membranes or broken skin Examples of semi critical devices are flexible endoscopes laryngoscopes endotracheal tubes respiratory therapy and anesthesia equipment diaphragm fitting rings and other similar devices Preparing the disinfecting solution The recommended disinfection solutions are as follows e Sodium hypochlorite 0 5 5000 ppm prepared fresh for use within 24 hours e Sodium hypochlorite 1 10000 ppm prepared fresh for use within 30 days The first solution can be prepared by adding 1 part household bleach sodium hypochlorite 5 25 to 9 parts water The second solution can be prepared by adding 1 part household bleach to 4 parts water System maintenance Cleaning and disinfecting 55 H The turbine flowmeter Guidelines recommend that the turbine should be cleaned and disinfected prior to every test to ensure accurate measurements and to comply with recommended sanitation measures as follow Cleaning the turbine Follow the standard cleaning procedure reported above paying attention to the following 1 For rinsing do not use flowing water which may damage the turbin
45. ions 12 The device should not come near any heat or flame sources flammable or inflammable liquids or gases and explosive properties 13 The device should not be used in conjunction with any other medical device unless that device is recommended by the manufacturer 14 The device should be used with a computer with electromagnetic compatibility CE marking and low radiation emission displays 15 The PC connected to the device must be compliant with EN 60601 1 by means of an isolation transformer Getting started Important notices 11 16 Precautions regarding EMC should be taken prior to installation and can be noted in the section EMC 17 Portable and mobile RF communication equipment may interfere with the performance of the device 18 Only the cable and accessories supplied with the equipment should be used with the device The use of accessories and or cables other than those supplied may result in increased emissions or decreased immunity of the equipment 19 The device should not be used adjacent to or stacked with other equipment If this is necessary you must verify that the device continues to operate normally in the configuration in which it will be used 20 The graphical symbols used with the device are described below Applied part type B EN60601 1 Applied part type BF EN60601 1 OFF ON Protective earth ground Alternating current Potential equalization node PC connection Connector for the
46. n E The mixing chamber option cleaning and disinfection Note Do not use alcohol solvents or other abrasive substances for cleaning the mixing chamber Disassembling the mixing chamber Depending on the mixing chamber version squared or rounded the proper following instructions applies Squared mixing chamber disassemble it by unscrewing the screws in the top cover T Tt port mii E Lidi er Rounded mixing chamber disassemble it by unscrewing the black knob on the rear side 60 System maintenance Cleaning and disinfecting Cleaning the mixing chamber Follow the standard cleaning procedure reported above Disinfecting the mixing chamber For disinfecting the mixing chamber plunge each part in the disinfecting solution for 20 minutes see turbine disinfection Rinse and wipe Reassembling the mixing chamber After the cleaning reassemble and carefully close the mixing chamber E Two way non rebreathing valve mixing chamber option cleaning and disinfection Refer to the indications reported in the sheet shipped together with the valve The valve must be disinfected after each usage on a patient H Cleaning and disinfecting the dosimeter nebulizer Cleaning and disinfecting should be performed after every patient 3 E gt Jro the Quark 1 Mouthpiece System maintenance Cleaning and disinfecting 61 Nebulizer upper half Jet Nebulizer lower half medicine reservoi
47. nce Any service operations not specified in this user manual should be only performed by qualified personnel in accordance with the service handbook Rubber mouthpieces face masks breathing valves and the other parts are not shipped sterile These should be disinfected before using according to the instructions in this section All materials used in the construction of the Quark and its accessories are non toxic and pose no Safety risks to the patient or operator The device should be turned off with the power supply disconnected prior to cleaning disinfecting and or inspecting the device The turbine should be disinfected regularly to ensure the accuracy of measurements If the recommended disposable anti bacterial filters are not used each part which comes into contact with the patient should be disinfected prior to each test 52 System maintenance System maintenance i Cleaning and disinfecting The goal of infection control is to prevent the transmission of infection to patients subjects and staff during pulmonary function testing Cleaning and disinfecting instructions should be strictly followed to control infections and assure the safety of the patient Aspiration of residue particles and or contaminated agents could be life threatening The recommendations in the following section are retrieved from Miller MR Crapo R Hankinson J et al General considerations for lung function testing Eur Respir J 2005 26 153
48. ndard packaging eee 34 DECO module standard PACKAGING essa ia 34 Respiratory Mechanics Module standard packaging eee 34 CPET Module standard PI RIEN iii 34 Oximeter module standard PACK ALIN nissan ica 35 Airway Resistances module standard packaging rire 35 Nutritional module standard Packaging rie 35 Mixing chamber module standard packaging ie 35 Dosimeter module standard packagihg eee 36 EN OD on RG CC6S jair 37 O SSR 38 A A o nn DR DINAR OE 40 E elia 40 ele A Ten e O o Eo HO A 40 Biala 41 Assembling the gas regulators on the cylinder ie 41 Connecting the hoses to the Vlinders u ae 42 Connecting the cylinders to the Quark u ir 43 H Assembling the breathing valve and the flowmeter sccssccssccssccsscssccssccssccscccsccnsscnsccssccssccssccsccessonssonssonscoess 43 H Assembling the flowmeter to the handle ccsccssccssccssccssccssccssccssccscccsccnsccnsccnccnsccnsscesccesccssccsccesscnssonssonscoess 44 H Assembling the VO max mask and the flowmetel ccssccsscsssccssccsccssccssccssccsccnsccnsccnsccesccssccsscesscesscessonsconscoess 45 a chet gy 2 Coat Me Roc PN ine mere tito one ete tere Reet SE os 45 H Reel 45 H Connecting the Quark to the power supply through the trolley ccssccssccssccsscssccssccssccssccsscnsscesscesscessossceess 45 1 Preparing the devi
49. ng 2 The following standards should be applied to ensure the accuracy of individual test results e Accessories should only be used as described in this manual The manufacturer does not warranty any non authorized accessories used by the end user The manufacturer may offer suggestions while using such accessories and the complications they could cause e Repairs or modifications of the device should ONLY be carried out by qualified and trained personnel e Environmental and electrical conditions in which the device operates should be in compliance with the specifications of this manual In particular grounding reliability and leakage current suppression can only be assured when the device three wire receptacle is connected to a yellow green return connected to earth ground Attempting to defeat the proper connection of the ground wire is dangerous for users and equipment e Equipment maintenance inspections disinfection and cleaning should be as described in this manual 3 Before powering on the system the power cords and plugs should be inspected Damaged electrical parts must be replaced immediately by authorized personnel 4 Large gas cylinders provided by the manufacturer or purchased by the customer must be secured with cylinder safety chains or safety stands as required by local law 5 After removing the protective cap of the cylinder you should inspect the cylinder valve for damaged threads dirt oil and or grease Any dust or
50. ng is necessary to remove all traces of detergent and extraneous debris Standard cleaning procedure These steps are common to all the cleaning procedures Step 1 Preparation at Point of Use The cleaning of reusable items begins soon after use At the point of use personnel wearing gloves and other protective attire separate disposable items or components from reusable items and discard them in appropriate receptacles Soil is wiped from device surfaces with a moist sponge or towel The soiled contaminated items are then contained in a manner that will reduce the risk of personal exposure to pathogens Items are usually placed in a basket tray or rigid container for transportation to the processing area usually transported inorona cart as hand carrying of soiled items is discouraged Step 2 Inspection Inspect the items for damage at all stages of handling If damage is detected on any of the components it should be identified and documented Complete the disinfection sterilization process and contact technical service for replacement Step 3 Presoak Protective attire is required of personnel handling contaminated items At the processing area soak or rinse the items in tap water 22 43 C Please note that rinse with flowing water is not possible on the turbine If an enzyme product is required soak for one to two minutes Remove and examine extend the soak time for components with dried on matter prolonged soaking of components may be detrime
51. not be disposed as unsorted municipal waste Electronic equipment must be collected separately according to the European Directive 2002 96 EEC Otherwise it can cause dangerous consequences for the environment and human health The crossed out wheeled bin means that the product must be taken to a separate collection when you wish to dispose of it 72 Appendix Disposing of electrical equipment Safety and conformity Safety IEC 60601 1 EN 60601 1 The complete classification of the device is as follows e Class with applied parts type B and BF e Protection against water penetration IPX1 e Non sterile device e Device not suitable in the presence of flammable anaesthetics e Continuous functioning equipment EMC The system meets the Standard IEC 60601 1 2 Paramagnetic O analyzer The paramagnetic oxygen analyzer meets the requirements of the Standard IEC 68 2 Basic Environmental Testing Procedures IEC 68 2 27 Shock Peak acceleration 100g 980 m s Duration 6msecs Pulse shape Half sine IEC 68 2 6 Sinusoidal vibration Frequency range 10Hz 500Hz Acceleration amplitude 1g 9 8 m s Type and duration of endurance 10 sweep cycles in each axis IEC 68 2 34 Random Vibration Wide Band Frequency range 20Hz 500Hz Acceleration spectral density 0 02 g Hz Duration 9 mins Quality Assurance UNI EN ISO 9001 2008 Registration n 387 A Cermet UNI EN ISO 13485 2003 Registration n 387 M Ce
52. ntal causing damage to the component surfaces Refer to the detergent instructions for its usage and soak time Step 4 Disassembly Disassemble the item if necessary according to the instructions reported in the corresponding section Step 5 Cleaning Protective attire is required for personnel handling contaminated items Manual cleaning must be done in a manner that protects personnel handling the devices from aerosolization and splashing of infectious material 1 Manual cleaning of the items should be done under 22 43 C water Use a neutral pH 7 mild detergent Water hardness temperature and the type of soil affect the effectiveness of the detergents the detergent manufacturer s instructions should be consulted Use a small soft brush to scrub all parts Abrasive cleaning compounds and implements can damage the items and should not be used Additional cleaning supplies may be required to clean stubborn stains or hard to reach areas 2 ltems must be thoroughly rinsed with clean water to remove the detergent residuals and debris from the components Use a flowing triple rinse cycle at a minimum with tap water Please note that rinse with flowing water is not possible on the turbine 3 Dryall components thoroughly using soft clean clothes or disposable paper towels E Disinfection The recommendations in this sections have been retrieved from William A Rutala Ph D M P H David J Weber M D M P H and the Healthcare Infect
53. o the patient during the required apnea time The body of the valve is made of ABS plastic with a silicone membrane used to open and close the breathing circuit The valve is easily connected to the flowmeter and easily disassembled for disinfection Either the patient should hold the valve or an articulated arm should can be used to support it HE The exercise test mask The exercise test masks are made of silicone and may be reused after proper disinfection see the chapter Maintenance These blue masks are available in different sizes and should be assembled the included head cap as shown in the chapter Exercise testing 24 Getting started System overview H The canopy hood The canopy hood allows the patient s exhaled air to blend with ambient air This mixture is then inspired by a pump with a known flow and the patient s Oxygen Consumption CO production and Energy Expenditure can be calculated H Paper mouthpieces J Paper mouthpieces are available for basic spirometry tests FVC VC and MVV The mouthpieces should not be used for any other testing H PTE soft mouthpieces The PTE soft mouthpieces are available for all tests other than spirometry Getting started System overview 25 E Antibacterial filters The use of antibacterial filters is recommended for infection control However regular cleaning and decontamination of lung function equipment should always be performed Note The use of antibacter
54. of optional products Turbine ID28 Option standard packaging Code Quantity Description C03400 01 04 ID28 turbine C03095 01 08 Handle for optoelectronic reader C00136 01 20 Adult paper mouthpieces A 182 300 004 Antibacterial filters C02210 02 08 Permapure sample line 2m C00214 01 20 OD22 paediatric adapter 2 1 50 5 1 1 Installation Before starting 33 PNT Option standard packaging Code Quantity Description C03600 01 05 2 PNT X9 C03095 01 08 Handle for reader A 182 300 004 Antibacterial filter C02210 02 08 Permapure 2m Spiro Turbine ID28 Option standard packaging Code Quantity Description C02550 01 04 2 ID28 turbine C03095 01 08 1 Handle for optoelectronic reader C00136 01 20 50 Adult paper mouthpieces C00137 01 20 50 Paediatric paper mouthpieces A 182 300 004 5 Antibacterial filters C00214 01 20 1 OD22 paediatric adapter Lung Volumes module standard packaging Code Quantity Description C02380 01 06 Smart valve C00269 01 20 PTE ID25mm soft mouthpiece A 182 300 004 Antibacterial filters C03563 01 10 FRC hose C03564 01 10 Ergo hose C02226 01 20 Membrane for Smart Valve DLCO module standard packaging Code Quantity Description C02380 01 06 1 Smart valve C00269 01 20 PTE ID25mm soft mouthpieces A 182 300 004 Antibacterial filters C03562 01 10 DLCO hose C02226 01 20 Membrane for Smart Valve Respiratory Mechanics Module standard packaging Code Quantity Description C03268 01 08 1 Pr
55. oftware PFT PC software CPET Mixing chamber module standard packaging Code Quantity C03348 01 04 C03189 01 05 A 800 900 025 C02106 01 08 A 108 300 008 C02106 01 08 C02181 01 08 C03427 01 94 C02753 01 10 Description Mixing chamber Two way non rebreathing valve Head support for 2 ways valve Head cap Large Wrinkled tube Spirometry mouthpiece adapter Adapter for reader Start up guide Mixing chamber mask Medium Installation Before starting 35 C01788 01 36 C01790 01 36 PC Software PFT PC software CPET Dosimeter module standard packaging Code Quantity Description C03560 01 11 1 C03515 01 08 1 C03482 01 08 C03222 01 20 C03425 01 20 A 862 010 001 A 661 919 003 A 182 300 004 36 Installation Before starting Dosimeter kit Dosimeter tube Nebulizers holder Dosimeter adapter Flowsafe antibacterial filter adapter DeVilbiss 646 Nebulizer Mouthpieces Antibacterial filter Options Accessories The following options are available with the Quark system Code Quantity Description A 860 000 004 Calibration cylinder 5 CO 16 O balance N3 A 860 000 005 DLCO cylinder 0 3 CO 0 3 CHy 21 O bal N A 860 000 006 DLCO cyl st state 0 1 CO 0 1 CH 21 O bal N A 860 000 007 Oxygen cylinder C02900 01 04 Trolley without arm C02870 01 04 Arm for trolley A 870 150 005 Pressure regulator for cal DLCO cylinder A 870 150 006 Pressure regulato
56. ot be accepted For European Community members The Pro Forma invoice should include the following e Number Appendix Service Warranty 69 e Description of the product e Quantity e Serial Number e Value in e Number of parcel e Gross weight e Net weight e Reason for repair If repairs are needed you may contact COSMED at the one of the following addresses COSMED S r l Via dei Piani di Monte Savello 37 P O Box 3 00041 Pavona di Albano Rome Italy tel 39 06 9315492 fax 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 usa sales cosmed it To ensure that you receive efficient technical service please specify the nature of the problem as indicated on the assistance information form You should save the original packaging in case the need to ship the unit to a technical assistance centre should arise 70 Appendix Service Warranty 1 Privacy Information Dear Customer We would like to inform you that your personal data is gathered and will be used by Cosmed Srl in conformity with the requirements of the Italian privacy law Decreto Legislativo 196 2003 We believe it is important for you to acknowledge how your personal data is handled H Personal data treatment and purposes We request and process your personal data for the following purposes
57. owmeter is used for RMR testing and it is provided with the Nutritional modules RMR Pneumotach Flowsafe The PNT flow measurements are obtained by measuring the pressure differential between the two sides of a polyester net The device may be used to measure a wide flow range and is not affected by ambient conditions pressure humidity room temperature exhaled gas composition Daily calibration of the PNT is not necessary but calibrations should be performed regularly to assure accurate measurements The PNT should be used for spirometry testing only Pneumotach X9 As for the Flowsafe the X9 calculates the flow by measuring the differential pressure between the two sides of a polyester net Getting started System overview 23 Differently from the Flowsafe the X9 can be reused after proper disinfection must be calibrated as the turbine flowmeter and can be used for all spirometry tests Each X9 is shipped with customized linearization tables It is necessary to load the tables from the included USB key into the software see section Calibration The USB key and X9 will have the same serial number Note The PNT X9 must be used with the COSMED antibacterial filter H The breathing valve q Gl gt E This breathing valve allows the breathing circuit to automatically switch between the demand valve connected to the gas cylinder and ambient air This valve closes during DLCO testing to block the air going t
58. r UI a N Tubing Routine cleaning After every test 1 Remove nebulizer tubing from nebulizer and from rear panel of Quark unit 2 Remove mouthpiece 3 Unscrew upper half of nebulizer from lower half and rinse all parts under warm water Daily 1 Wash all components in soapy water If jet is clogged use a pin to re open the aperture 2 Rinse with warm tap water for 30 seconds then soak in one part white vinegar to three parts hot water for 30 minutes 3 Rinse with warm tap water and air dry Monthly 1 Replace or clean tubing by following nebulizer cleaning instructions To remove excess water from tubing attach to the air source and allow air to pass through tubing until excess moisture is removed Disinfection Disassemble as above Place all the parts in the disinfectant solution for at least 20 minutes Let them dry in air The mouthpieces and the adapters must be disinfected only The nebulizer components may be sterilised by autoclaving or boiling They may also be sterilised with any germicidal agent suitable for Lexan Always prepare fresh solution for each cleaning cycle 62 System maintenance Cleaning and disinfecting Sampling line maintenance Permapure e Donot bend squash or deform the sampling line Any kink in the sample line will reduce the internal lumen of the line and affect accuracy of measurement e Do not keep the sampling line open to the atmosphere particularly in crow
59. r for O cylinder C03101 01 10 Paediatric mask Small for RMR C03102 01 10 Paediatric mask Large for RMR C03103 01 10 Paediatric mask Large for VO max Installation Options Accessories 37 System description The Quark system consists of the main unit and its accessories The following picture displays the correct assembly 14 13 gt Lao J 10 Trolley PC shelf Drawer Printer shelf Supplementary shelf Cylinders Quark unit Location for smart valve turbine etc 19 O ae A NO Mouse shelf 10 Arm 11 Vice for arm fixing 12 Breathing valve 13 Turbine 38 Installation System description 14 Antibacterial filter Installation System description 39 1 Quark installation Before operating the system you should make sure that environmental and operational conditions have been met see Chapter 1 H Quark front panel 1 Power switch 2 Led on off 3 Gas calibration connection SM Quark rear panel 1 Tanks 0 00 psi Sampling DLCO 02 002 Cal 02 2 l i 4 5 6 in 21 ne dL m 7 Ra tido Room Air vO 8 AM e TELE DE ma pone FE 20 a E 4 T EE 10 11 12 13141516 17 18 PNT MIP MEP PO 1 connector Permapure sampling line connector Breathing valve connector DLCO cylinder connector O CO cylinder connector Oxygen cylinder connector Supplemental earthing terminal Dosimeter connec
60. relationship is displayed The slope of the lower component 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 in excess of that derived from aerobic metabolism must be generated from the buffering of lactic acid This is seen in all subjects exercising at work levels above their LT References OVS Original V Slope method A new method for detecting anaerobic threshold by gas exchange Beaver Wasserman Whipp JAP 1986 60 2020 2027 MVS Modified V Slope method Metabolic acidosis during exercise in patients with chronic obstructive pulmonary disease Sue Wasserman CHEST 1988 94 931 938 H Oxygen Kinetics Delayed Kinetics of VO2 in the Transition from prior Exercise Evidence for O2 Transport Limitation of VO2 Kinetics A Review R L Hughson and M A Morrissey Int J Sports Med 4 1983 31 39 ISO 8996 Ergonomics Determination of metabolic heat production 1990 The following picture displays how O debt and O deficit values are calculated Y A B exp t to Tau 02 Kinetics YSA4B exp t t1 Tau VO2 rest A B VO2 rest A VO2 work B VO2 woark B 5 to start work tl start work tl stop work t2 end test O2def VO2 work Tau O2debt VO2 work tau NNS VO2 l min VO2 work VO2 rest VOZ rest 0 0 50 150 t1 200 250 300 time fsec _ NX 05 f
61. rmet Medical Device Directive CE mark MDD 93 42 EEC Notified Body 0476 Class lla Appendix Safety and conformity 73 Technical features Flowmeter ID28 turbine ID18 turbine Type Bidirectional Bidirectional Diameter int 28mm 18mm Flow range 0 16 l s 0 8 I s Volume range 0 300 I min 0 50 I min Resolution 12 ml 3 ml Accuracy 2 or 20 ml s 2 or 20 ml s Resistance lt 0 6 cmH O I s lt 0 7 cmH O I s 14 l s 31 s O analyzer Type Paramagnetic Response time 120 ms Range 0 30 0 100 FRC Accuracy 0 1 Resolution 0 01 0 03 FRC Warm up time CO analyzer 5 min Type Digital infrared Response time 100 ms Range 0 10 Accuracy 0 1 Resolution 0 01 Warm up time 10 min CO analyzer Type Infrared Response time 200 ms Range 0 0 35 Accuracy 0 003 Resolution 0 001 Warm up time 15 min CH 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 of Nafion Permapure Power Supply 100V 240V 10 50 60Hz 100VA Voltage Power consumption 74 Appendix Technical features Flowsafe PNT Lilly 0 14 l s 1 ml 2 or 20 ml s lt 1 cmH 0 1 s 14 1 s X9 PNT Lilly 28mm 0 14 l s 1 ml 2 or 20 ml s lt 1 cmH 0 I s 14 1 s Environmental Sensors Temperature Barometer Humidity 0 50 C 400 800 mmHg 0 100 Dimension and Weight
62. s Relative contraindications Bronchial obstruction caused by performing respiratory manoeuvres Moderate or serious bronchial obstruction FEV lt 1 51 in men and FEV lt 1 21 in women Recent respiratory infection Recent Asthma exacerbation Hypertension Pregnancy Epilepsy Getting started Contraindications 13 H Contraindications for Exercise testing Absolute contraindications e Acute MI within 2 days e High risk unstable angina e Uncontrolled cardiac arrhythmias causing symptoms of hemodynamic compromise e Active endocarditis e Symptomatic severe aortic stenosis e Decompensated symptomatic heart failure e Acute pulmonary embolus or pulmonary infarction e Acute noncardiac disorder that may affect exercise performance or be aggravated by exercise eg infection renal failure thyrotoxicosis Acute myocarditis or pericarditis Physical disability that would preclude safe and adequate test performance Inability to obtain consent Relative contraindications e Left main coronary stenosis or its equivalent e Moderate stenotic valvular heart disease e Electrolyte abnormalities e Tachyarrhythmias or bradyarrhythmias e Atrial fibrillation with uncontrolled ventricular rate e Hypertrophic cardiomyopathy e Mental impairment leading to inability to cooperate e High degree AV block Note Relative contraindications can be superseded if benefits outweigh risks of exercise Read carefully the exercise testing ch
63. s for the arms should be placed in the subclavicular areas Limb electrodes for the legs should be placed on the trunk at the level of the bottom rib Installation Preparing the device and the patient for exercise testing 47 Warning QRS morphology may be slightly different from the standard ECG due to the different positioning of lower limb electrodes To reduce these differences attempt to position the LL electrode as low as possible Using a mouthpiece instead of a face mask When performing sub maximal tests with ventilation values maintained at less than 100 L min you may use the combination rubber mouthpiece filter and nose clip in place of the mask Assemble the mouthpiece filter and reader as illustrated in the following picture Assure that no leaks are present between the patient and the mouthpiece 48 Installation Preparing the device and the patient for exercise testing How to contact COSMED You may contact the manufacturer directly at the following address for 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 it Internet http www cosmed com Complaints feedback and suggestions If you have any complaints feedback or suggestions you may inform us at complain cosmed it Installation How to contact COSMED 49 System maintenance System maintena
64. seneesauss 13 H Contraindications for Bronchial Provocation testing ccssccssccssccsccssccssccscccscccsccnssccsscesccesccesccsscesscesscscouscees 13 AROE CON Ut ea liceale 13 Relative contraindicat ONE naar 13 E Contraindications for Exercise testing iii 14 Absolute CONTANTI 14 Relative CONTAIN O E TIERE 14 O Environmental condition OF Use 15 E Liza 16 E Cervelli 20 TB AS nn O O 21 LI System overview nennen 22 EU 22 POW ENING ON the QOVICO ea oi A tt 22 Powers onf ine 21 61 tito 22 Ni A O o O 22 nn A 22 Pieumolach HON iii aio 23 PEANO ICA AAA A e o o A 23 E TUE VANE ita ia 24 E eee A e e E EE O 24 No o 1 878 AAA acari 25 on PI 25 IP aaa 25 BLA 26 Eilat 26 A E OO O A 26 TICO AE EIA 26 A a re PE FEE Pi 27 E TASTE CUAD ica 27 A 27 O System A o o POUR OR TITTI RR RR A 29 El Beer ri ene pani ri 32 E CHECKING the packing Contents 32 A A A A 32 Quark Spiro Sle Oddi Secas od ANCA SAA N CA 32 Quark PFT standard packaging ccccsscsscosssssssscossussescosccussescosecussessosccsccustussesccustussescosstussescosseursassosceursassescs 32 Quark CPET standard packagihg eee 32 E Packaging of optional products siria 33 Turbine 1D23 Option standard packaging orinando ida 33 PNTOptionstandard packaging sprint 34 Spiro Turbine ID28 Option standard packaging ooccocccncncncncncnnnnnncnnnnonanonanonaconaconononononononcnnanonanonaronanoninonons 34 Lung Volumes module sta
65. smitter should be worn against bare skin to ensure successful operation If a transmitter is worn over a shirt the shirt should be wet underneath the electrode area to achieve proper conductivity To acquire the most accurate HR signal you should place the HR probe as close as possible to the HR belt ECG electrodes Correct electrode placement is important for acquiring a successful ECG signal Patient preparations that may be performed to improve the signal include the removal of oils lotions and hair from the skin 1 a 2 HW N RA RL Vi v2 Shave the area in which the electrodes will be placed Using a slightly abrasive cloth cut an X where the electrodes will be placed Rub the area with gauze that has been saturated with either ether or acetone Remove any residual with dry gauze Apply the patient cable to the electrodes and place them as shown in the following picture Note The patient cable and the transmitter are not water proof You should prevent any liquids from penetrating the area and avoid submerging the electrodes in liquid A The electrodes should be placed as follows V1 V2 V3 V4 V5 V6 Ath intercostal space to the right of the sternum Ath intercostal space to the left of the sternum Between V2 and V4 electrodes 5th intercostal space on the midclavicular line 5th intercostal space on the anterior axillary line 5th intercostal space on the left midaxillary line Limb electrode
66. tal environment IEC 61000 4 4 1 kV for 1 kV for input output input output lines lines Surge 1 kV differential 1 kV differential Mains power quality should be that of a typical IEC 61000 4 5 mode mode commercial or hospital environment 2 kV common 2 kV common mode mode Voltage dips short lt 5 Ur 5 Ur Mains power quality should be that of a typical interruptions and gt 95 dip in Uy gt 95 dip in Ur commercial or hospital environment If the user of voltage variations on for 0 5 cycles for 0 5 cycles the device requires continued operation during power supply input 40 Ur 40 Ur power mains interruptions it is recommended that lines 60 dip in Ur 60 dip in Uy for the device be powered from an uninterruptible IEC 61000 4 11 for 5 cycles 5 cycles power supply or a battery 70 Ur 70 Ur 30 dip in Ur 30 dip in Uy for for 25 cycles 25 cycles lt 5 Ur lt 5 Ur gt 95 dip in Uy gt 95 dip in Uy for 5 sec for 5 sec Power frequency Power frequency magnetic fields should be at levels 50 60 Hz magnetic characteristic of a typical location in a typical field commercial or hospital environment IEC 61000 4 8 Nota U is the a c mains voltage prior to application of the test level Getting started EMC 17 Guidance and manufacturer s declaration electromagnetic immunity The device is intended for use in the electromagnetic environment specified below The customer or
67. the user of the device should assure that it is used in such an environment Immunity test Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 Notes Test level IEC 60601 1 3 Veff 150 kHz to 80 MHz 3 V m 80 MHz to 2 5 GHz Compliance level 1 At 80 MHz the higher frequency range applies Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the device including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 17 P d 1 17 4P 80 MHz to 800 MHz d 2 33N P 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol A 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM ra
68. tor 19 PP S ee ee Zu en Medical air connector 40 Installation Quark installation 10 RS232 connector for PC 11 Temp RH probe connector 12 USB connector for PC 13 Auxiliary USB connector for HR probe 14 Turbine connector 15 Reset button 16 Auxiliary RS232 connector for ergometer control 17 Oximeter PNT Roccconnector for PNT Rocc an adapter is required 18 Auxiliary TTL input output 19 Connector for the soda lime CO absorber output already connected 20 Power cable plug 21 Soda lime CO absorber slot already connected M Calibration cylinders In order to calibrate the sensors the following calibration cylinders are required Cylinder Recommended Gas Mixture Test Calibration O 16 CO 5 N Bal FRC CV CPET RMR DLCO CO 0 3 CH 0 3 O 21 N Bal DLCO Oxygen O 100 FRC CV Cylinder can be placed into the trolley housings option Note The cylinders must contain a calibration certificate which indicates the gas concentrations Assembling the gas regulators on the cylinder Attach the gas regulator on the cylinder as shown in the following picture The white washer should be inserted between the cylinder and the gas regulator Installation Quark installation 41 Warning The regulator should be tightly connected to avoid leaks Note Gas regulators have different adapters depending on the gas mixture they are created for Assure that the proper gas r
69. troduction Decontamination is a multi step process that includes preparation at point of use thorough cleaning and rinsing and a microbicidal process Thorough cleaning and rinsing are the first and most important steps in the reprocessing of any reusable medical device Without thorough cleaning and rinsing it might not be possible to achieve high level disinfection or sterilization of the device The purpose of cleaning and rinsing is to remove all adherent visible soil to reduce the number of particulates and microorganisms and to reduce the amount of pyrogenic and antigenic material Any organic material lubricants or residual cleaning agents remaining on a device can inactivate liquid chemical disinfectants sterilants as well as protect microorganisms from destruction The second step in decontamination is the microbicidal process which is defined as a process to provide a particular level of microbial lethality kill COSMED components are classified as semi critical items which are devices that come into contact with intact mucous membranes Semi critical devices at a minimum require a high level disinfection procedure Sterilization is not absolutely essential COSMED components require complete or partial disassembly for cleaning and disinfection It is the responsibility of the user health care personnel for ensuring that the cleaning methods recommended can be duplicated in their environment that appropriate tools and replacement par
70. ts 64 System maintenance Inspections 1 Replace the fuses The fuses can be replaced by performing the following procedure 1 Open the power supply cover using a screwdriver as shown in the picture above 2 Extract the fuse holder as shown above 3 Replace the damaged fuse s Note Assure that the appropriate fuses are used when replacing previous fuses A 680 024 125 Time Lag Fuses 5x20 250V T1 25A System maintenance Replace the fuses 65 Dichiarazione di conformit Manufacturer COSMED S r l Address Via dei Piani di Monte Savello 37 00041 Pavona di Albano Laziale RM ITALY phone 39 06 9315492 fax 39 06 9314580 manufacturer of the following equipment Quark Spiro Quark PFT Quark CPET declares under his sole responsibility that e the above listed equipment comply with the essential requirements of the Annex of the Medical Device Directive 93 42 EEC e are classified in Class lla e their design manufacturing and final checks are performed according the Cosmed s Quality System conform to ISO 9001 2008 and IS013485 2003 Norms certified by CERMET certificates nr 387 A and 387 M e are CE marked according to the Medical Device Directive 93 42 EEC and certified by CERMET certificate nr MED 9811 The equipment conform with the following specifications Safety IEC 60601 1 EMC IEC 60601 1 2 C 0476 68 Appendix Dichiarazione di conformita
71. ts are available and that instructions are followed correctly H Cleaning Note Please refer to additional specific cleaning instructions for the turbine assembly below Cleaning Agents supplies Mild detergents with a neutral pH 7 are recommended for cleaning Use warm water 22 43 c with the mild detergent To be effective cleaning agents must assist in the removal of residual organic soil without damaging the device cleaning agents should be used in the correct dilution concentration and at the correct temperature in accordance with the cleaning agents manufacturer s directions Cleaning supplies are very basic usually consisting of a surgical scrub brush chenille pipe cleaners cotton or foam tipped applicators soft brushes and soft cloths Cleaning supplies should be cleaned and disinfected or sterilized daily Water Quality tap water is acceptable for use in cleaning COSMED components COSMED components should be soaked and rinsed in tap water at 22 43 C to prevent the coagulation of solid substances onto the device and thus facilitate the removal of debris 54 System maintenance Cleaning and disinfecting Enzymatic detergents with a neutral pH 7 are recommended when processing difficult to clean items with dried on matter Soaking mask and valve components in an enzymatic detergent solution can effectively remove visible debris except for lubricants thus providing an acceptable alternative to manual cleaning Rinsi
72. water pasteurization an alternative approach for disinfection it can be performed in place of step 1 and 2 Completely immerse the device components in a hot water bath All surfaces should be in direct contact with the hot water for 30 minutes at temperatures set between 71 76 C Step 4 Drying To prevent the growth of waterborne organisms the mask and components should be thoroughly dried prior to reassembly and storage 1 Dry thoroughly using a soft cloth preferably sterile or disposable paper towels Step 5 Inspection All components should be visually inspected for cleanliness proper function and freedom of defects Visual inspection provides evidence of thorough cleaning and proper functioning of all mask and components Mask assemblies in poor working condition are hazardous to personnel and patients 1 Visually inspect all components for cleanliness If there are signs of residue from the detergent or disinfectant repeat the previous steps If there are any signs of remaining stains or organic debris repeat the previous steps If the cleaning and disinfection steps have been repeated with no improvement eliminating residual or stains etc then dispose of the components and replace 2 Visually inspect all components for defects Check the rubber parts for tears nicks hardening or stiffening deformation or distortion Check the plastic parts for crazing cracking or stripped threads Any defective parts should be discarded and repl

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