Cosmed Quark PFT User manual

Manuale Utente
User Manual
Manuel d’utilisation
Benutzerhandbuch
Manual del Usuario
Quark PFT
Quark CPET
Quark SPIRO

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.
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Lotus 123 is a registered trademark of Lotus Development Corporation.
Quark User manual, XIII Edition
01/2018
Copyright © 2012 COSMED
COSMED Srl - Italy
http://www.cosmed.com
Part N. C03262-02-91

2
Table of Contents
Table of Contents ................................................................................................................................................................... 2
Getting Started ...................................................................................................................................................................... 7
 Important Notices ................................................................................................................................................................................................8
 Intended Use.................................................................................................................................................................................................8
Specific Indications for Use ............................................................................................................................................................................8
Measured Parameter Table............................................................................................................................................................................9
 Warnings.......................................................................................................................................................................................................9
 Contraindications...............................................................................................................................................................................................11
 Contraindications for the Spirometry...........................................................................................................................................................11
Absolute Contraindications..........................................................................................................................................................................11
Relative Contraindications...........................................................................................................................................................................11
 Contraindications for Bronchial Provocation Testing....................................................................................................................................11
Absolute Contraindications..........................................................................................................................................................................11
Relative Contraindications...........................................................................................................................................................................11
 Contraindications for Exercise Testing..........................................................................................................................................................12
Absolute Contraindications..........................................................................................................................................................................12
Relative Contraindications...........................................................................................................................................................................12
 Environmental Conditions for Operation ............................................................................................................................................................13
 Overview............................................................................................................................................................................................................14
 Introduction.......................................................................................................................................................................................................15
 System Overview ...............................................................................................................................................................................................16
 Quark Unit...................................................................................................................................................................................................16
Powering on the device ...............................................................................................................................................................................16
Powering off the device...............................................................................................................................................................................16
 Flowmeter(s)...............................................................................................................................................................................................16
Turbine Flowmeter......................................................................................................................................................................................16
Pneumotach X9 (PNT)..................................................................................................................................................................................17
 The Breathing Valve ....................................................................................................................................................................................17
 Hans Rudolph V2 Exercise Testing Mask.......................................................................................................................................................18
 Paper mouthpieces......................................................................................................................................................................................19
 Soft PTE Mouthpieces ..................................................................................................................................................................................19
 Antibacterial filters......................................................................................................................................................................................19
 Nose Clips....................................................................................................................................................................................................20
 HR Monitor..................................................................................................................................................................................................20
 Oximeter .....................................................................................................................................................................................................20
 ROCC PNT.......................................................................................................................................................................................................20
 Mixing Chamber..........................................................................................................................................................................................21
 Dosimeter....................................................................................................................................................................................................21
 System Warm-Up...............................................................................................................................................................................................22
Installation.......................................................................................................................................................................... 23

3
 Before Starting.................................................................................................................................................................................................. 24
 Checking the Packing contents.................................................................................................................................................................... 24
 Optional Modules........................................................................................................................................................................................ 24
 Options / Accessories .................................................................................................................................................................................. 25
 System Description............................................................................................................................................................................................ 26
 Quark Installation.............................................................................................................................................................................................. 27
 Quark front panel........................................................................................................................................................................................ 27
 Quark Unit Rear Panel................................................................................................................................................................................. 28
 Gas Cylinders (Calibration and Testing) ....................................................................................................................................................... 29
Install the gas regulators on the cylinder .................................................................................................................................................... 29
Connect the hoses to the regulators............................................................................................................................................................ 30
Connect the hoses to the Quark................................................................................................................................................................... 30
 Assemble the Breathing Valve and flowmeter ............................................................................................................................................ 30
Turbine ....................................................................................................................................................................................................... 31
PNT X9 ........................................................................................................................................................................................................ 31
 Attach the flowmeter to the handle............................................................................................................................................................ 31
 Connect the breathing valve and/or the flowmeter to the Quark................................................................................................................. 32
 Assemble the VO2max mask and the turbine flowmeter.............................................................................................................................. 32
 Assemble the ROCC PNT................................................................................................................................................................................. 33
 Connect the Quark to the computer (PC) ..................................................................................................................................................... 33
 Power the Quark Unit when installed on the Optional Trolley ..................................................................................................................... 33
 Prepare the Quark Unit and Subject for Exercise Testing .................................................................................................................................... 34
 Prepare the Quark....................................................................................................................................................................................... 34
 Subject Preparation .................................................................................................................................................................................... 34
 Select the correct mask size for the subject ................................................................................................................................................. 34
 Assemble the Flowmeter and Mask............................................................................................................................................................. 35
The Mask .................................................................................................................................................................................................... 36
 Secure the mask.......................................................................................................................................................................................... 36
 Mask Leak Test............................................................................................................................................................................................ 36
The HR Monitor........................................................................................................................................................................................... 37
ECG Electrodes ............................................................................................................................................................................................ 38
Testing with a Mouthpiece.......................................................................................................................................................................... 39
 Contact COSMED................................................................................................................................................................................................ 40
Comments, Feedback and Suggestions ....................................................................................................................................................... 40
System Cleaning & Maintenance ............................................................................................................................................41
 System Maintenance......................................................................................................................................................................................... 42
 Cleaning & Disinfection ..................................................................................................................................................................................... 43
 Introduction................................................................................................................................................................................................ 43
 Prevention of infection transmission........................................................................................................................................................... 43
Transmission to technicians ........................................................................................................................................................................ 43
Cross-contamination................................................................................................................................................................................... 43
Tuberculosis................................................................................................................................................................................................ 43
Haemoptysis and oral lesions...................................................................................................................................................................... 43
Other known transmissible infectious diseases ........................................................................................................................................... 43
Disposable in-line filters ............................................................................................................................................................................. 43

4
 Other precautions and warnings..................................................................................................................................................................43
 Decontamination.........................................................................................................................................................................................45
 Pretreatment...............................................................................................................................................................................................45
 Water ..........................................................................................................................................................................................................45
 Maintenance ...............................................................................................................................................................................................45
 Procedure For Third-Party Products .............................................................................................................................................................45
 Symbols ......................................................................................................................................................................................................45
 Spirometry Tests ................................................................................................................................................................................................46
 Cleaning and Disinfection Methods ........................................................................................................................................................47
 Disposable items .......................................................................................................................................................................................53
 CPET & RMR Tests...............................................................................................................................................................................................54
 Cleaning and Disinfection Mmethods .....................................................................................................................................................55
 Disposable Items .........................................................................................................................................................................................60
 Mixing Chamber Test .........................................................................................................................................................................................61
 Cleaning and Disinfection Methods ........................................................................................................................................................67
 Disposable items........................................................................................................................................................................................74
 Rocc test ............................................................................................................................................................................................................75
75
 Cleaning and Disinfection Methods ........................................................................................................................................................76
 Disposable Items........................................................................................................................................................................................77
 Sampling line maintenance (Permapure)...........................................................................................................................................................78
 Equipment Inspection........................................................................................................................................................................................79
 Fuse Replacement..............................................................................................................................................................................................80
Appendix............................................................................................................................................................................. 81
 EMC ...................................................................................................................................................................................................................82
 Declaration of Conformity ..................................................................................................................................................................................86
 Service - Warranty..............................................................................................................................................................................................87
 Warranty and limitation of liability..............................................................................................................................................................87
 Return goods policy for warranty or non-warranty repair ............................................................................................................................87
 Repair Service Policy....................................................................................................................................................................................87
 Privacy Information............................................................................................................................................................................................89
 Personal data treatment and propose..........................................................................................................................................................89
 How your personal data is treated ...............................................................................................................................................................89
 Consent .......................................................................................................................................................................................................89
 Responsible party........................................................................................................................................................................................89
 Customer rights...........................................................................................................................................................................................89
 Disposing of electrical equipment ......................................................................................................................................................................90
 Safety and conformity........................................................................................................................................................................................91
Safety..........................................................................................................................................................................................................91
EMC.............................................................................................................................................................................................................91
Paramagnetic O2analyzer............................................................................................................................................................................91
Quality Assurance........................................................................................................................................................................................91
Medical Device Directive (CE mark)..............................................................................................................................................................91
 Technical Specifications .....................................................................................................................................................................................92
Flowmeter...................................................................................................................................................................................................92

5
O2analyzer.................................................................................................................................................................................................. 92
CO2analyzer................................................................................................................................................................................................ 92
CO analyzer................................................................................................................................................................................................. 92
CH4analyser................................................................................................................................................................................................ 92
Humidity absorber...................................................................................................................................................................................... 92
Power Supply.............................................................................................................................................................................................. 92
Environmental Sensors ............................................................................................................................................................................... 92
Dimension and Weight ............................................................................................................................................................................... 92
Oximeter..................................................................................................................................................................................................... 92
Accuracy specifications................................................................................................................................................................................ 92
 Refernces - Calculations..................................................................................................................................................................................... 93
 VO2and VCO2............................................................................................................................................................................................... 93
 Anaerobic Threshold (modified V-Slope)..................................................................................................................................................... 93
References .................................................................................................................................................................................................. 93
 Oxygen Kinetics .......................................................................................................................................................................................... 93
 Predicted Sets.................................................................................................................................................................................................... 94
 Automatic Diagnosis (algorithm) ................................................................................................................................................................ 95
 Quality Control Messages............................................................................................................................................................................ 96
 References......................................................................................................................................................................................................... 97
Spirometry.................................................................................................................................................................................................. 97
Dosimeter................................................................................................................................................................................................... 97
Lung Volumes............................................................................................................................................................................................. 97
Single-Breath with Apnoea......................................................................................................................................................................... 97
Single-Breath without Apnoea.................................................................................................................................................................... 97
MIP/MEP..................................................................................................................................................................................................... 97
P0.1 ............................................................................................................................................................................................................ 97
Resistance................................................................................................................................................................................................... 97
Gas Exchange.............................................................................................................................................................................................. 97
Indirect Calorimetry .................................................................................................................................................................................... 98
Sub-maximal exercise testing ..................................................................................................................................................................... 98
Oximeter..................................................................................................................................................................................................... 98
Canopy........................................................................................................................................................................................................ 98
General....................................................................................................................................................................................................... 98

Getting Started

8 - Getting Started - Important Notices
 Important Notices
 Intended Use
The COSMED Quark Series is a modular system with multiple configurations which can perform the following tests: Spirometry, Lung Function,
Cardiopulmonary Exercise, and Resting Metabolic Testing.
The system and its accessories are indicated for the acquisition, analysis, formatting, display, printing and storage of certain physiologic parameters.
The main measurements which are displayed by this product line are Oxygen Uptake, Carbon Dioxide Production, Air Flow, Ventilation, Heart Rate
and Energy Expenditure. It is intended to assist a clinician in the diagnosis of cardiac and pulmonary diseases.
Caution: Federal law restricts the sale of this device by or on the order of a licensed healthcare practitioner to be sold to the order of a physician.
The Quark Series devices must not be used as monitoring device, nor as a sole means for determining a patient’s diagnosis, but for the purpose of
assisting the clinician in the cardiac and pulmonary cardio-pulmonary diseases.
This equipment is intended to be used for the following applications:
• Understanding and Formulating lung pathology diagnosis
• Assisting with human physiology studies
• Contributing to sports medicine applications
COSMED Srl is not responsible for incidents which occur due to improper use of this device. Examples include:
• Operation of the device by unqualified individuals
• Use of the device not indicated by this manual
• Not complying with the precautions and instructions described in this manual
Specific Indications for Use
Model Indication for Use Major Clinical Applications Measured Parameters
Quark
SPIRO
Pulmonary Function testing (Age 6 to adult) Spontaneously breathing
patients, healthy or individuals
affected by respiratory disease
(asthma or COPD, etc.)
FVC, FEV1, FEF25-75%, PEF,
MVV, SpO2
Quark PFT Pulmonary Function testing
(Age 6 to adult)
Cardiopulmonary Exercise Testing (Age 6 to adult)
Spontaneously breathing
patients, healthy or individuals
affected by respiratory disease
(asthma or COPD, etc.)
FVC, FEV1, FEF25-75%, PEF,
MVV, FRC, DLCO, MIP/MEP,
P0.1, SpO2, Ve, RF, HR, VO2,
VCO2, TGV
Quark CPET Pulmonary Function testing (Age 6 to adult)
Cardiopulmonary Exercise testing (Age 6 to adult)
Spontaneously breathing
patients, healthy or individuals
affected by diseases which limit
exercise tolerance
FVC, FEV1, FEF25-75%, PEF,
MVV, VO2, VCO2, Ve, RF, HR,
SpO2
Quark SPIRO and Quark PFT can also measure Airways Resistance Test using the interrupter technique (ROCC test) for pediatric patients (3 to 6 years
old). ROCC technique was specifically developed for pediatric population and uncooperative children unable to perform spirometric maneuvers (FVC,
SVC, etc.). The interrupter technique is possible to perform with preschool children, with repeatable results that correlate well with “gold
standard” techniques.