Cosmed microQuark User manual

Manuale Utente
User Manual
Manuel d’utilisation
Benutzerhandbuch
Manual del Usuario
microQuark
PC-based Spirometer

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.
microQuark User manual, XVII Edition
05/2015
Copyright © 2012 COSMED
COSMED Srl - Italy
http://www.cosmed.com
Part N. C02268-02-91

2

Table of contents
Table of contents........................................................................................................................................................................ 3
Getting started........................................................................................................................................................................... 5
Important notices................................................................................................................................................................................................6
Intended use.................................................................................................................................................................................................6
Warnings ......................................................................................................................................................................................................6
Contraindications ................................................................................................................................................................................................8
Contraindications for the spirometry testing .................................................................................................................................................8
Absolute contraindications ...........................................................................................................................................................................8
Relative contraindications.............................................................................................................................................................................8
Contraindications for Bronchial Provocation testing......................................................................................................................................8
Absolute contraindications ...........................................................................................................................................................................8
Relative contraindications.............................................................................................................................................................................8
Environmental condition of use...........................................................................................................................................................................9
EMC...................................................................................................................................................................................................................10
Overview of the manual ....................................................................................................................................................................................14
Introduction ......................................................................................................................................................................................................15
MicroQuark overview.........................................................................................................................................................................................16
MicroQuark unit..........................................................................................................................................................................................16
The flowmeter ............................................................................................................................................................................................16
Paper mouthpieces .....................................................................................................................................................................................17
Antibacterial filters .....................................................................................................................................................................................17
Nose clips....................................................................................................................................................................................................17
Installation .............................................................................................................................................................................. 19
Before starting ..................................................................................................................................................................................................20
Checking the packing contents....................................................................................................................................................................20
Options/Accessories ....................................................................................................................................................................................20
Preparing MicroQuark........................................................................................................................................................................................21
How to contact COSMED ....................................................................................................................................................................................22
Complaints, feedback and suggestions .......................................................................................................................................................22
System maintenance ................................................................................................................................................................ 23
System maintenance.........................................................................................................................................................................................24
Cleaning and disinfecting ..................................................................................................................................................................................25
Prevention of infection transmission...........................................................................................................................................................25
Transmission to technicians ........................................................................................................................................................................25
Cross-contamination...................................................................................................................................................................................25
Tuberculosis................................................................................................................................................................................................25
Haemoptysis and oral lesions......................................................................................................................................................................25
3

Other known transmissible infectious diseases............................................................................................................................................25
Disposable in-line filters ..............................................................................................................................................................................25
Other precautions and warnings..................................................................................................................................................................25
Introduction ................................................................................................................................................................................................26
Cleaning......................................................................................................................................................................................................26
Cleaning Agents/supplies ............................................................................................................................................................................26
Standard cleaning procedure.......................................................................................................................................................................26
Disinfection .................................................................................................................................................................................................27
Preparing the disinfecting solution..............................................................................................................................................................27
. The turbine flowmeter...............................................................................................................................................................................27
Cleaning the turbine....................................................................................................................................................................................27
Disinfecting the turbine...............................................................................................................................................................................27
Precautions to take when cleaning, disinfecting and drying the turbine......................................................................................................28
Inspections.........................................................................................................................................................................................................29
Appendix ................................................................................................................................................................................. 31
Dichiarazione di conformità ...............................................................................................................................................................................32
Service - Warranty..............................................................................................................................................................................................33
Warranty and limitation of liability..............................................................................................................................................................33
Return goods policy for warranty or non warranty repair.............................................................................................................................33
Repair Service Policy....................................................................................................................................................................................33
Privacy Information............................................................................................................................................................................................35
Personal data treatment and purposes ........................................................................................................................................................35
How your personal data is treated ...............................................................................................................................................................35
Consent .......................................................................................................................................................................................................35
Holder of the personal data .........................................................................................................................................................................35
Customer rights...........................................................................................................................................................................................35
Disposing of electrical equipment ......................................................................................................................................................................36
Safety and conformity........................................................................................................................................................................................37
Safety..........................................................................................................................................................................................................37
EMC.............................................................................................................................................................................................................37
Quality Assurance........................................................................................................................................................................................37
Medical Device Directive (CE mark)..............................................................................................................................................................37
Technical features..............................................................................................................................................................................................38
Predicted values.................................................................................................................................................................................................39
Automatic diagnosis (algorithm).................................................................................................................................................................40
Quality Control Messages.............................................................................................................................................................................40
References .........................................................................................................................................................................................................42
Spirometry ..................................................................................................................................................................................................42
Resistance ...................................................................................................................................................................................................42
Oximeter .....................................................................................................................................................................................................42
General........................................................................................................................................................................................................42
4

Getting started

Important notices
Intended use
MicroQuark is an electrical medical device designed to perform pulmonary function tests. It is to be used by physicians or by trained personnel on a
physician responsibility.
Caution: Federal law restricts this device to be sold by the order of a physician.
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.
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.
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 non-authorized 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. 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.
5. The cleaning procedures and inspections in the System Maintenance section should be performed prior to each test.
6. 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).
7. The device should not come near any heat or flame sources, flammable or inflammable liquids or gases and explosive properties.
8. The device should not be used in conjunction with any other medical device unless that device is recommended by the manufacturer.
9. The device should be used with a computer with electromagnetic compatibility, CE marking and low radiation emission displays.
10. The PC connected to the device must be compliant with EN 60601-1 by means of an isolation transformer.
11. Precautions regarding EMC should be taken prior to installation and can be noted in the section EMC.
12. Portable and mobile RF communication equipment may interfere with the performance of the device.
6 - Getting started - Important notices

13. 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.
14. 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.
15. 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
Getting started - Important notices - 7

Contraindications
Performing forced expiratory manoeuvres involved in spirometry testing may be contraindicated in certain conditions.
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 3rd month.
For 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, but the following contraindications should be acknowledged prior to testing:
Absolute contraindications
•Severe bronchial obstruction (decreased FEV1in adults).
•Recent myocardium infarct.
•Recent cerebral vascular accident.
•Known arterial aneurysm.
•Incapacity for understanding the provocation test procedures and its implications.
Relative contraindications
•Bronchial obstruction caused by performing respiratory manoeuvres.
•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
8 - 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]:
•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 - 9

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 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.
Harmonic Emission
IEC 61000-3-2
Class A
Voltage Fluctuations /
Flicker Emission
IEC 61000-3-3
Complies
10 - 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
IEC 60601-1
Compliance level
Electromagnetic environment – guidance
Electrostatic discharge
(ESD)
IEC 61000-4-2
±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%.
Electrical fast
transient/burst
IEC 61000-4-4
±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.
Surge
IEC 61000-4-5
±1 kV differential
mode
±2 kV common
mode
±1 kV differential
mode
±2 kV common mode
Mains power quality should be that of a typical commercial or
hospital environment.
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
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic fields s
hould be at levels
characteristic of a typical location in a typical commercial or
hospital environment.
Nota: UTis the a.c. mains voltage prior to application of the test level.
Getting started - EMC - 11

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
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Veff
150 kHz to
80 MHz
3 V/m
80 MHz to
2.5 GHz
3 V
3 V/m
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
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
12 - 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
P
80 MHz to 800 MHz
d=1.17
P
800 MHz to 2.5 GHz
d=2.33
P
0.01
0.12
0.12
0.23
0.1
0.37
0.37
0.74
1 1.17 1.17 2.33
10 3.70 3.70 7.38
100 11.70 11.70 23.33
For transmitters rated at a maximum output power not 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 - 13

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.
14 - Getting started - Overview of the manual

Introduction
MicroQuark is an instrument designed for lung function screening; the core of the system is the “intelligent” flowmeter that, connected to a
Personal Computer (laptop or desktop), turns it in a complete spirometric lab.
The system is composed by the turbine flowmeter, the measurement and data elaboration device (lightweight and ergonomic), the
communication cable and by the Software pack.
Getting started - Introduction - 15

MicroQuark overview
MicroQuark is mainly made of:
•MicroQuark unit
•Flowmeter
•Other accessories
Let us see an overview of the parts and their assembly.
MicroQuark unit
The unit is the core of the device, with the electronics and cables for its working.
The flowmeter
The turbine flowmeter is made of a handle (the reader) with a hole, in which it is placed the turbine.
The air passing through the helical conveyors, takes a spiral motion which causes the rotation of the turbine rotor. The rolling blade interrupts the
infrared light beamed by the two diodes of the reader. Every interruption represents 1/4 turn of the rotor, this allows to measure the number of
turn in the time.
For hygienic reasons, we strongly recommend the use of a bacterial filter, to be connected as in the picture by side.
Note: While inserting the turbine, be sure to push the turbine up to touch the end of the reader.
16 - Getting started - MicroQuark overview

Paper mouthpieces
Paper mouthpieces are available for basic spirometry tests (FVC, VC, and MVV). The mouthpieces should not be used for any other testing.
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.
Nose clips
Nose clips should be used during spirometry testing to prevent respiration through the nasal passage while performing testing manoeuvres.
Getting started - MicroQuark overview - 17