Quark series User Manual XIII Edition Jan 2018

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 2

 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

3

 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 O2 analyzer ... 91 Quality Assurance ... 91 Medical Device Directive (CE mark) ... 91  Technical Specifications ... 92 Flowmeter ... 92

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O2 analyzer... 92 CO2 analyzer ... 92 CO analyzer ... 92 CH4 analyser ... 92 Humidity absorber ... 92 Power Supply ... 92 Environmental Sensors ... 92 Dimension and Weight ... 92 Oximeter ... 92 Accuracy specifications... 92  Refernces - Calculations... 93  VO2 and VCO2... 93  Anaerobic Threshold (modified V-Slope) ... 93 References ... 93  Oxygen Kinetics ... 93  Predicted Sets... 94  Automatic Diagnosis (algorithm) ... 95  Quality Control Messages ... 96  References ... 97 Spirometry ... 97 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

5

 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 FVC, FEV1, FEF25-75%, PEF, patients, healthy or individuals MVV, VO2, VCO2, Ve, RF, HR, affected by diseases which limit SpO2 exercise tolerance

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.

8 - Getting Started - Important Notices

Measured Parameter Table

Parameter

Description

Parameter

Description

FVC

Forced Expiratory Vital Capacity

P0.1

Respiratory Drive

FEV1

Forced Expiratory Volume in 1 sec

VE

Ventilation

FEF25-75%

Mid-expiratory flow between 25-75% of the FVC

RF

Respiratory frequency

PEF

Peak Expiratory Flow

HR

Heart Rate

MVV

Maximum Voluntary Ventilation

VO2

Oxygen uptake

FRC

Functional Residual Capacity

VCO2

Carbon Dioxide production

DLCO

CO Diffusion Capacity

SpO2

Hemoglobin saturation

MIP

Maximum inspiratory pressure

TGV

Thoracic Gas Volume

MEP

Maximum expiratory pressure

Warnings 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. There is a bibliography of all references in the AppendixThis User Manual has been developed in accordance with the Class IIa European Medical Device Directive requirements Warning: To avoid risk of electric shocks, this device must be connected to sockets with protective earth Read and understand these precautions before operating the device to ensure the safety of user and subject 1. This User Manual should always be available as a reference while testing 2. The following standards should be applied to ensure the accuracy of individual test results: • Accessories should only be used as they are described in this manual. The manufacturer does not warranty the use of any unauthorized accessories. The manufacturer may offer suggestions while using third-party accessories and the complications which may occur • Device Service and Repair should ONLY be performed by COSMED authorized and trained personnel • Environmental and electrical conditions in which the device operates must comply with this manual. Note that the reliability of the device ground and leakage current suppression is only assured when the three-wire power cord is connected to a grounding point (yellow-green return connected to earth ground). Any attempt to avoid the proper groung connection is dangerous for both the user and equipment • Equipment maintenance, inspections, disinfection and cleaning should be as described in this manual. 3. Prior to powering on the system, the power cords and plugs should be fully inspected. Any damaged electrical part(s) must be replaced immediately by COSMED authorized personnel. 4. Gas cylinders: a. Large gas cylinders provided by the manufacturer or purchased by the customer must be secured with cylinder safety chains or safety stands as required by local law b. After removing the cylinder’s protective cap, the valve should be inspected for damaged threads, dirt, oil and/or grease. Any dust or dirt should be removed; however, the cylinder should not be used if oil, grease, or damaged threads are present c. Ensure that the pressure regulator is compatible with the intended gas cylinder (chemically and physically) prior to installation d. The regulator must be properly connected and working pressure adjusted and displayed on the regulator e. Close cylinder before disconnecting the cylinder from the 5. 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. Each component in contact with the subject’s breath should be cleaned and disinfected prior to each test 6. The cleaning procedures and inspections in the System Cleaning & Maintenance section should be performed prior to each test 7. 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 definitions) 8. The device should not come near any heat or flame sources, flammable or inflammable liquids or gases and explosive properties 9. The device should not be used in conjunction with any other medical device unless that device is recommended by the manufacturer Getting Started - Important Notices - 9

10. The device should be used with a computer with electromagnetic compatibility, CE marking and low radiation emission displays 11. The PC connected to the device must be compliant with EN 60601-1 by means of an isolation transformer 12. Precautions regarding EMC should be taken prior to installation and can be noted in the section EMC 13. Portable and mobile RF communication equipment may interfere with the performance of the device 14. Only the cables and accessories supplied with the equipment should be used with the device. The use of any other accessories and/or cables may result in increased emissions or decreased immunity of the equipment 15. The device should not be placed adjacent to or stacked either on top or under other equipment. If this is absolutely necessary, the device operation must be verified to ensure normal operation The graphical symbols used with the device are described below:

Applied part type B (EN60601-1)

Potential equalization node

Applied part type BF (EN60601-1)

PC connection

OFF

Connector for the RH/TA sensor

ON Protective earth ground

USB connector

Alternating current

HR probe connector

Refer to the instructions for use

10 - Getting Started - Important Notices

TTL auxiliary input/output

 Contraindications Performing forced expiratory maneuvers in spirometry testing may be contraindicated as outlined below.

Contraindications for the Spirometry Absolute Contraindications

FVC, VC and MVV tests: 

Post-operative thoracic surgery patients

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

FVC tests: • Spontaneous post-pneumothorax • Arterial-venous aneurysm • Severe arterial hypertension • Pregnant with complications in the 3rd month (12 weeks) MVV tests: 

Hyperventilation syndrome

Contraindications for Bronchial Provocation Testing Bronchial Provocation testing must be executed under the direction of a physician. Testing is considered safe when executed properly in a clinical setting, however the following contraindications should be acknowledged prior to testing: Absolute Contraindications • • • • •

Severe bronchial obstruction (decreased FEV1 in adults) Recent myocardium infarction Recent cerebral vascular accident Known arterial aneurysm Inability to understand the provocation testing procedures implications

Relative Contraindications • • • • • • •

Bronchial obstruction caused by performing respiratory maneuvers Moderate or serious bronchial obstruction (FEV1 < 1.51 in men and FEV1 < 1.21 in women) Recent respiratory infection Recent Asthma exacerbation Hypertension Pregnancy Epilepsy

Contraindications for Exercise Testing Absolute Contraindications • • • • • • • • • • •

Acute MI (within the past 2 days) High-risk/unstable angina Uncontrolled cardiac dysrhythmias causing symptoms of hemodynamic compromise Active endocarditis Symptomatic severe aortic stenosis Decompensated symptomatic heart failure Acute pulmonary embolus or pulmonary infarction Acute non-cardiac disorder that may affect exercise performance or be aggravated by exercise (e.g., infection, renal failure, thyrotoxicosis) Acute myocarditis or pericarditis Physical disability that would preclude safe and adequate test performance Inability to obtain consent

Relative Contraindications • • • • • • • •

Left main coronary stenosis or its equivalent Moderate stenotic valvular heart disease Electrolyte abnormalities Tachyarrhythmias or bradyarrhythmias Atrial fibrillation with uncontrolled ventricular rate Hypertrophic cardiomyopathy Mental impairment leading to inability to cooperate High-degree AV block Note: Relative contraindications can be superseded if benefits outweigh risks of exercise.

Review the section, Prepare the Quark Unit and Subject for Exercise Testing

12 - Getting Started - Contraindications

 Environmental Conditions for Operation 1. COSMED devices should not be operated near explosive substances 2. COSMED devices should not be installed near electrical or magnetic devices such as x-ray equipment, transformers or power lines. These devices could create electrical interference when performing testing procedures. 3. 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 4. COSMED devices should be operated under normal environmental temperatures and conditions [IEC 60601-1/EN 60601-1]: • Temperature: 10°C (50°F) and 40°C (104°F) • Relative humidity: 30% to 90% (not condensing) • Atmospheric Pressure: 600 mBar (450 mmHg) to 1060 mBar (795 mmHg) • Avoid operating equipment in the presence of noxious fumes or in a dusty environment • Do not place units near heating sources • Cardiopulmonary resuscitation equipment should be accessible in the case of an emergency • Adequate floor space and easy access to the subject during exercise testing is necessary • Adequate ventilation should be maintained in the room the testing is to be performed • No other testing should be performed in the room simultaneously

Getting Started - Environmental Conditions for Operation - 13

 Overview This manual is organized in the following chapters: 1. Getting Started –Describes the intended use of the device, how to properly use it and features of the unit and accessories 2. Installation – Lists the steps required to properly install the device 3. System Cleaning & Maintenance –Describes system cleaning, disinfection and routine maintenance procedures 4. 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 reading both manuals before using this device.

14 - Getting Started - Overview

 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 specific application: Quark Spiro

Quark PFT

Quark CPET

Spirometry







Lung Volumes

-



-

Diffusing Capacity (DLCO)

-



-

Respiratory Mechanics

-



-

CPET

-





Dosimeter





-

Oximeter







Airway Resistance





-

Mixing Chamber

-





 Standard  Optional

The Quark Spiro and Quark PFT must be configured with either the turbine flowmeter or X-9 PNT Each module will allow the following tests to be performed: Module

Tests Available

Spirometry

FVC, VC, MVV

Lung Volumes

FRC (via Nitorgen Wash-out), Closing Volume

Diffusing Capacity (DLCO)

Diffusing Capacity (with or without apnea, or intra-breath method)

Respiratory Mechanics

MIP/MEP, P0.1

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

Airways Resistance using the interrupter technique (Rocc)

Mixing Chamber

Exercise testing using the mixing chamber technique (ideal for sports medicine)

Getting Started - Introduction - 15

 System Overview The Quark Series consists of the following main parts: • Quark unit • Flowmeter • Breathing valve (if required) • Additional external sensors and devices (temperature-humidity, HR, oximeter)

Quark Unit

The Quark unit contains the following elements: • Power switch (located on the front panel) • Connectors and ports (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 powered on

Flowmeter(s) 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 concentration). Daily calibration of the turbine is not necessary, however calibrations should be performed regularly to ensure accurate measurements. There are three turbine flowmeters: ID28, ID28 Spiro and ID18.

VO2max

16 - Getting Started - System Overview

The ID28 flowmeter can be used for all tests except for RMR testing and is provided with the Quark PFT and Quark CPET units and CPET module

VO2max The ID28 Spiro flowmeter is identical to the ID28 with the absence of a sampling line. This flowmeter should only be used for spirometry testing when exhaled gas analysis is not necessary. This flowmeter is provided with the Quark Spiro unit.

RMR

The ID18 flowmeter is used for RMR testing and it is provided with the Nutritional assessment module Pneumotach X9 (PNT)

The X9 calculates the flow by measuring differential pressure between the two sides of a polyester mesh net. The X9 can be reused, after proper disinfection and must be calibrated using the same procedure asthe turbine flowmeter, however it is required to calibrate prior to each test. It can be used for all spirometry tests Each X9 is shipped with an individualized linearization table. It is necessary to load the table from the paired USB drive (same serial number) into OMNIA, see the Calibration chapter for more information. NOTE: The PNT X9 can ONLY be used with the COSMED antibacterial filter

The Breathing Valve

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 to 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 There are 2 versions of the breathing valve depending on which flowmeter is used (PNT X9 or Turbine)

Getting Started - System Overview - 17

Hans Rudolph V2 Exercise Testing Mask The exercise test masks are made of silicone and may be reused after proper disinfection (see the chapter System Cleaning & Maintenance). These blue masks are available in different sizes and should be assembled the included head cap as shown in the chapter Exercise testing. Mask without Inspiratory Valves (Required for Exercise Flow Volume Loops)

Turbine Assembly with Mask

The canopy hood

18 - Getting Started - System Overview

Mask with Inspiratory Valves

The canopy hood allows mixes the exhaled air from the subject with ambient air. This mixture is then drawn by a pump with a known flow and the subject’s Oxygen Consumption, CO2 production and Energy Expenditure can be calculated.Paper mouthpieces

Paper mouthpieces are available for simple spirometry tests (FVC, VC, and MVV). The mouthpieces should not be used for any other testing.

Soft PTE Mouthpieces

The soft PTE mouthpieces are available for all lung function tests other than spirometry.

Antibacterial filters

Antibacterial filters are recommended for infection control, however, this does not eliminate the need for regular cleaning and decontamination of lung function equipment Note: The use of antibacterial filters is recommended even when using disposable mouthpieces to prevent crosscontamination

Getting Started - System Overview - 19

Nose Clips

Nose clips should be used during spirometry testing to prevent respiration through the nasal passage while performing testing maneuver

HR Monitor The HR Monitor consists of three parts: the elastic belt containing the transmitter and the USB receiver. The parts should be near one another for the most effective communication signal

Oximeter

The oximeter probe should be placed on the patient’s finger to measure oxygen saturation both at rest and during exercise. The probe should be oriented with the image of the finger on the top and the cable running down the hand as shown in the image above

ROCC PNT

The Rocc PNT measures airway resistance by interrupter technique

20 - Getting Started - System Overview

Mixing Chamber

The mixing chamber is a 8.7-liter plexiglass cylinder for resting or exercise or resting dtudies utilizing the mixing chamber modality instead of breathby-breath

Dosimeter

The dosimeter is comprised of a nebulizer and accessories used to deliver the bronchoprovocator to the subject during bronchoprovocation tests. The package includes nebulizer, tube to connect to quar, mouthpiece and multiple adapters, detailed information on operation can be found in the Dosimeter chapter

Getting Started - System Overview - 21

 System Warm-Up Each Quark unit must be warmed up prior to use for the required amount of time. The warm-up time depends on which test is being performed. Below is a table displaying minimum warm-up times based on each test: Test

Warm-up Time (mins)

FVC, VC, MVV

-

FRC

5

CV

5

DLCO

15

MIP/MEP

-

P0.1

-

Oximetry

-

ROCC

-

CPET

5

RMR

5

During the warm-up, the device must be powered on, however the software does not need to be open. Calibration and/or testing procedures should not be performed until the warm-up period has been completed.

22 - Getting Started - System Warm-Up