Quark RMR User Manual 6th Edition June 2013

Table of contents Table of contents ... 3 Getting started ... 7 

Important notices ... 8  Intended use ... 8 Specific Indications for use ... 8 Description of the acronyms used in measured parameters ... 8  Warnings ... 9



Environmental condition of use... 11

 

EMC ... 12 Overview of the manual ... 16



System overview ... 17  Quark unit... 17 Powering on the device ... 17 Powering off the device... 17  The flowmeter ... 17  The canopy hood ... 18

 Antibacterial filters ... 18  The HR probe ... 18  System warm-up ... 19

Installation... 21 

Before starting... 22  Checking the packing contents... 22  Device packaging ... 22 Quark RMR standard packaging... 22  Packaging of optional products ... 23 CPET Module standard packaging ... 23 Mixing chamber module standard packaging ... 23

 

ICU module standard packaging ... 23 Options/Accessories ... 24 Quark installation ... 25  Quark RMR front panel ... 25  Quark RMR rear panel ... 25  Calibration cylinders ... 26 Assembling the gas regulators on the cylinder ... 26 Connecting the hoses to the cylinders ... 27 Connecting the cylinders to the Quark... 27  Connecting the Quark to the PC ... 28  Connecting the Quark to the power supply through the trolley ... 28 3



How to contact COSMED... 29 Complaints, feedback and suggestions... 29

System maintenance ... 31 

System maintenance... 32



Cleaning and disinfecting ... 33  Prevention of infection transmission... 33 Transmission to technicians ... 33 Cross-contamination ... 33 Tuberculosis ... 33 Haemoptysis and oral lesions... 33 Other known transmissible infectious diseases ... 33 Disposable in-line filters ... 33  Other precautions and warnings ... 33  Introduction ... 34  Cleaning ... 34 Cleaning Agents/supplies... 34 Standard cleaning procedure ... 35  Disinfection ... 35 Preparing the disinfecting solution... 35  The turbine flowmeter ... 36 Cleaning the turbine ... 36 Disinfecting the turbine ... 36 Precautions to take when cleaning, disinfecting and drying the turbine... 36  Cleaning and disinfecting the RMR canopy hood and veil (option) ... 36 Cleaning hood and veil ... 36 Disinfecting hood and veil... 36  The mixing chamber (option): cleaning and disinfection ... 36 Disassembling the mixing chamber ... 36 Cleaning the mixing chamber... 37 Disinfecting the mixing chamber ... 37 Reassembling the mixing chamber. ... 37

 Two-way non rebreathing valve (mixing chamber option) cleaning and disinfection ... 37  Adapter and ICU wrinkled tube cleaning ... 38  Sampling line maintenance (Permapure) ... 39  

Inspections ... 40 Replace the fuses ... 41

Appendix ... 43  

Dichiarazione di conformità ... 44 Service - Warranty ... 45  Warranty and limitation of liability ... 45  Return goods policy for warranty or non warranty repair ... 45  Repair Service Policy ... 45



Privacy Information ... 47  Personal data treatment and purposes ... 47  How your personal data is treated ... 47  Consent ... 47

4

 Holder of the personal data ... 47  Customer rights ... 47  

Disposing of electrical equipment ... 48 Safety and conformity ... 49 Safety ... 49 EMC ... 49 Paramagnetic O2 analyzer ... 49



Quality Assurance ... 49 Medical Device Directive (CE mark) ... 49 Technical features ... 50 Flowmeter ... 50 O2 analyzer ... 50 CO2 analyzer ... 50 Humidity absorber ... 50 Power Supply ... 50 Environmental Sensors... 50 Dimension and Weight ... 50 Accuracy specifications ... 50



References... 51 Indirect Calorimetry ... 51 Canopy ... 51 ICU... 51

5

 Important notices

 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: 

Formulating of a 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 Device model

Indication for use

Major clinical conditions

Measured parameters

Quark RMR

Measurement of Resting Metabolism – age 6 to adults;

Spontaneously breathing patients;

VO2, VCO2, Ve, RF, HR, SpO2

Measurement of Resting Metabolism (canopy dilution) –15Kg/30Lb to adults; Measurement of Resting Metabolism (Ventilated patients) – age 10 to adults

Ventilated patients with some limitations as in accordance with labeling

To assure for quality and accurate measurements during ventilator testing the following is mandatory: 1. The exhaled gases being measured at ventilators exhalation port should only include the patients exhaled gas and bias flow generated by the ventilator. 2. Avoid any leak of gas from the patient/ventilator system, including leaks in the ventilator circuit, leaks around tracheal tube cuffs or uncuffed tubes, leaks through chest tubes or bronchopleural fistula 3. Ventilator bias flow must be properly calibrated and detected prior to testing. 4. Delivered oxygen concentration (FiO2) must be stable and lower than 50%. Instability can be due to changes in source gas pressure and ventilator blender/mixing characteristics 5. Avoid presence of anesthetic gases or gases other than O 2, CO2, and N2 in the ventilation system 6. Inaccurate measurement of REE and RQ occurs during peritoneal and hemodialysis due to removal across the membrane of CO2 that is not measured by the Quark RMR. Description of the acronyms used in measured parameters Parameter

Description

VO2

Oxygen uptake

VCO2

Carbon Dioxide production

Ve

Ventilation

RF

Respiratory frequency

HR

Heart Rate

8 - Getting started - Important notices

SpO2

Hemoglobin saturation

 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. All bibliography references are reported in the Appendix. This 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. 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 testing. 2. The following standards should be applied to ensure the accuracy of individual test results: 

 



Accessories should only be used as described in this manual. The manufacturer does not warranty any nonauthorized accessories used by the end user. The manufacturer may offer suggestions while using such accessories and the complications they could cause; Repairs or modifications of the device should ONLY be carried out by qualified and trained personnel; 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. 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 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. 9. 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 definitions). 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. 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.

Getting started - Important notices - 9

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 RH/TA sensor TTL auxiliary input/output USB connector HR probe connector Refer to the instructions for use

10 - Getting started - Important notices

 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]: 

Temperatures range: 10°C (50°F) and 40°C (104°F).



Relative humidity range: 30% to 90% (not condensing).

 

Atmospheric Pressure range: 600 mBar to 1060 mBar. Avoid operating equipment in the presence of noxious fumes or in dusty environments.



Do not place units near heat sources.

 

Cardiopulmonary resuscitation equipment should be accessible in the case of an emergency. Adequate floor space and easy access to the patient during exercise testing is necessary.



Adequate ventilation should be maintained in the room the testing is performed.

Getting started - Environmental condition of use - 11

 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 device should assure that it is used in such an environment. Emissions test

Compliance

Electromagnetic environment – guidance

RF emissions CISPR 11

Group 1

The device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11

Class B

Harmonic Emission IEC 61000-3-2 Voltage Fluctuations / Flicker Emission IEC 61000-3-3

Class A

The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

12 - Getting started - EMC

Complies

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 IEC 60601-1

Electrostatic discharge (ESD) IEC 61000-4-2

Compliance level

Electromagnetic environment – guidance

±6 kV contact ±8 kV air

±6 kV contact ±8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

±2 kV for power supply lines ±1 kV for input/output lines

±2 kV for power supply lines ±1 kV for input/output lines

Mains power quality should be that of a typical commercial or hospital environment.

±1 kV differential mode

±1 kV differential mode

Mains power quality should be that of a typical commercial or hospital environment.

±2 kV common mode

±2 kV common mode

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

<5% UT (>95% dip in UT) for 0.5 cycles 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 sec

<5% UT (>95% dip in UT) for 0.5 cycles 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 sec

Mains power quality should be that of a typical commercial or hospital environment. If the user of the device requires continued operation during power mains interruptions, it is recommended that the device be powered from an uninterruptible power supply or a battery.

Power frequency (50/60 Hz) magnetic field

3 A/m

3 A/m

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Electrical transient/burst IEC 61000-4-4

fast

Surge IEC 61000-4-5

IEC 61000-4-8 Nota: UT is the a.c. mains voltage prior to application of the test level.

Getting started - EMC - 13

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 IEC 60601-1

Compliance level

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 P 80 MHz to 800 MHz

Conducted RF IEC 61000-4-6

3 Veff 150 kHz to

3V

80 MHz Radiated RF

3 V/m

IEC 61000-4-3

80 MHz to 2.5 GHz

3 V/m

d=2.33 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 surveya, should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol:

Notes: (1) At 80 MHz, 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. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio 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

14 - 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 output power of transmitter (W)

Separation distance according to frequency of transmitter (m) 150 kHz to 80 MHz d=1.17

80 MHz to 800 MHz

P

d=1.17

800 MHz to 2.5 GHz

P

d=2.33

0.01

0.12

0.12

0.23

0.1

0.37

0.37

0.74

1

1.17

1.17

2.33

10

3.70

3.70

7.38

100

11.70

11.70

23.33

P

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 applicable 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 - 15

 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.

16 - Getting started - Overview of the manual

 System overview The Quark RMR consists of the following parts:  Quark RMR unit 

Flowmeter



Additional external sensors and devices (temperature-humidity, HR,…).

 Quark unit

The Quark unit contains the following elements: 

The power switch (located on the front panel)



The Canopy pump switch (located on the rear panel) 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. To turn on the Canopy pump, use the switch on the rear panel. After an initial test, the green led turns on to indicate that the pump works properly. 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. To turn off the Canopy pump, use the switch on the rear panel. Note: Always remember to turn off the Quark RMR and the Canopy pump (if on) at the end of the working session.

 The flowmeter

Getting started - System overview - 17

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.

 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, CO2 production and Energy Expenditure can be calculated. The Quark RMR incorporates the canopy hood with the unit, and has a backup battery to ensure continuous working even if the mains is not powering the system.

 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 antibacterial filters is recommended even when using disposable mouthpieces to prevent cross-contamination.

 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.

18 - Getting started - System overview

 System warm-up Before using the Quark RMR the system must be warmed up for at least 10 minutes: 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 - 19

Installation

 Before starting Before operating the Quark RMR you should inspect the equipment and complete the product registration.

 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.

 Device packaging Quark RMR standard packaging Code

Quantity

Description

C00974-01-04

1

Quark RMR Unit

C02500-02-04

1

ID18 turbine

C03047-01-20

1

ID18 turbine adapter

C02656-01-06

1

T/RH probe

C03880-01-10

1

Canopy hood

C02678-01-07

1

Canopy wrinkled tube

C03886-01-10

1

Canopy vail

A-182-300-004

5

Antibacterial filters

C00269-01-20

5

Soft mouthpiece (PTE ID25mm)

A-662-100-001

2

Nose clip

C02210-02-08

1

Permapure sample line 2m

A-182-310-001

5

Anti moisture filters

C03561-01-10

1

RMR hose

A-661-200-071

1

Elastic belt

A-661-200-070

1

HR monitor

A-661-200-039

1

HR receiver

A-362-315-010

1

USB extension cable

C00600-01-11

1

3 litres calibration syringe

A-362-050-001

1

Power cable

A-362-300-001

1

RS232 cable

A-362-315-001

1

USB cable

A-680-024-125

2

Time lag fuse 5x20 250V T1,25A

C01790-01-36

1

PC software CPET

C03262-02-91

1

User Manual

C03939-02-91

1

Software manual

22 - Installation - Before starting

 Packaging of optional products CPET Module standard packaging Code

Quantity

Description

C03400-01-04

1

ID28 turbine

C03611-01-10

1

Mask VO2max Small

C03612-01-10

1

Mask VO2max Medium

C03613-01-10

1

Mask VO2max Large

A-800-900-022

1

Head cap for the adult masks (L)

A-800-900-023

1

Head cap for the adult masks (S, M)

C02210-02-08

1

Permapure sample line 2m

C03564-01-10

1

Ergo hose

C02500-02-04

1

ID18 turbine

C02580-01-05

5

RMR masks

A-661-200-071

1

Elastic belt

A-661-200-070

1

HR monitor

A-661-200-039

1

HR receiver

A-362-315-010

1

USB extension cable

C03309-01-12

1

PFT input/output HR TTL cable

C01790-01-36

1

PC software CPET

Mixing chamber module standard packaging Code

Quantity

Description

C03348-01-04

1

Mixing chamber

C03189-01-05

1

Two-way non rebreathing valve

A-800-900-025

1

Head support for 2-ways valve

C02106-01-08

1

Head cap Large

A-108-300-008

1

Wrinkled tube

C02181-01-08

1

Adapter for reader

C02753-01-10

1

Mixing chamber mask Medium

C01788-01-36

1

PC Software PFT

C01790-01-36

1

PC software CPET

ICU module standard packaging Code

Quantity

Description

A-180-100-001

20

Sampling line extension

A-820-173-001

20

ICU connector with luer lock

C03116-01-20

2

ICU adapter

A-108-300-009

1

ICU wrinkled tube

C01050-01-09

2

Adapter for ICU calibration

A-180-015-004

5

Permapure

A-108-130-002

1

Silicone tube

C03395-01-20

2

Silicone tube - ID18 turbine adapter

Installation - Before starting - 23

 Options/Accessories The following options are available with the Quark RMR system: Code

Quantity

Description

A 860 000 004

1

Calibration cylinder (5% CO2, 16% O2, balance N2)

A 870 150 005

1

Pressure regulator for cal./DLCO cylinder

C03101-01-10

1

Paediatric mask Small for RMR

C03102-01-10

1

Paediatric mask Large for RMR

24 - Installation - Options/Accessories