Cosmed does not assume the liability for interpretation mistakes of this
documentation 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 express permission of COSMED Srl.
COSMED Software can be installed only in one device.
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 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 sale by or on the
order of a physician.
This equipment has been conceived with the aim of providing an
auxiliary instrument allowing:
• the formulation of lung pathology diagnosis;
• important studies concerning human physiology;
• the collection of important information in sport medicine.
No responsibility attaches COSMED Srl for any accident
happened after a wrong use of the device, such as:
• use by non qualified people;
• non respect of the device intended use;
• non respect of the hereunder reported precautions and
instructions.
Warnings
The device, the program algorithms and the presentation of
measured data have been developed according to the
specifications of ATS (American Thoracic Society) and ERS
(European Respiratory Society). Other international references
have been followed when these were not available. All
bibliography references are reported in Appendix.
The present handbook has been developed with respect of the
European Medical Device Directive requirements which sort
microQuark within Class II a.
It is recommended to read carefully the following precautions
before putting the device into operation.
The precautions reported below are of fundamental importance to
assure the safety of all COSMED equipment users.
1. This user manual is to be considered as a part of the medical
device and should always be kept on hand.
2. Safety, measure accuracy and precision can be assured only:
8 - microQuark User Manual
• using the accessories described in the manual or given
with the device. Actually non recommended accessories can
affect safety unfavourable. Before using non recommended
accessories it is necessary to get in touch with the
manufacturer;
• ordinary equipment maintenance, inspections,
disinfection and cleaning are performed in the way and with
the frequency described;
• any modification or fixing is carried out by qualified
personnel;
• the environmental conditions and the electrical plants
where the device operates are in compliance with the
specifications of the manual and the present regulations
concerning electrical plants. 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.
3. Before powering the system, check the power cables and the
plugs. Damaged electrical parts must be replaced
immediately by authorised personnel.
4. Cleaning residue, particulates, and other contaminates
(including pieces of torn or broken components) in the
breathing circuit pose a safety risk to the patient during
testing procedures. Aspiration of contaminates can
potentially be life-threatening. You must follow all the
cleaning procedures in System Maintenance, and you must
thoroughly inspect the components after cleaning and before
each patient test.
5. This device is not suitable for use in presence of flammable
anaesthetics. It is not an AP nor an APG device (according to
the EN 60 601-1 definitions).
6. Keep the device away from heat and flame source,
flammable or inflammable liquids or gases and explosive
atmospheres.
7. In accordance with their intended use microQuark is not to
be handled together with other medical devices unless it is
clearly declared by the manufacturer itself.
Chapter 1 - Getting started - 9
8. It is recommended to use a computer with electromagnetic
compatibility CE marking and with low radiation emission
displays.
9. It is necessary to make the PC, connected to the
microQuark,
compliant with EN 60601-1 by means of an isolation
transformer.
10. Graphical symbols used in accordance to present
specifications are described here below:
Equipment type B (EN60601-1)
Danger: high temperature
OFF
ON
Protective earth ground
Alternating current
10 - microQuark User Manual
Contraindication
The physical strain to execute the respiratory manoeuvre is
contraindicated in case of some symptoms or pathology. The
following list is not complete and must be considered as a piece
of mere information.
Contraindications for the Spirometer tests
Absolute contraindications
For FVC, VC and MVV tests:
• Post-operating state from thoracic surgery
For FVC tests:
• Severe instability of the airways (such as a destructive
bronchial emphysema)
• Bronchial non-specific marked hypersensitivity
• Serious problems for the gas exchange (total or partial
respiratory insufficiency)
Relative contraindications
For FVC tests:
• spontaneous post-pneumothorax state
• arterial-venous aneurysm
• strong arterial hypertension
• pregnancy with complications at the 3
For MVV test:
• hyperventilation syndrome
rd
month.
Contraindications for Bronchial provocation tests
The bronchial provocation tests must be executed according to
the doctor’s discretion. There are not data that reveal specific
contraindication for the bronchial provocation test through
inhalation.
The modern standard processes have been revealing secure in
several clinical studies. However it is recommendable to respect
the following contraindications:
Chapter 1 - Getting started - 11
Absolute contraindications
• Serious bronchial obstruction (FEV1 in adults)
• Recent myocardium infarct
• Recent vascular-cerebral accident
• Known arterial aneurysm
• Incapacity for understanding the provocation test procedures
and its implications.
Relative contraindications
• Bronchial obstruction caused by the respiratory manoeuvre.
• Moderate or serious bronchial obstruction. For ex. Predicted
value FEV1 less than 1.51 in men and predicted value FEV1
in women less than 1.21.
• Recent infection in the superior air tracts
• During the asthmatic re-acuting
• Hypertension
• Pregnancy
• A pharmacology treatment epilepsy
12 - microQuark User Manual
Environmental condition of use
COSMED units have been conceived for operating in medically
utilised rooms without potential explosion hazards.
The units should not be installed in vicinity of x-ray equipment,
motors or transformers with high installed power rating since
electric or magnetic interferences may falsify the result of
measurements or make them impossible. Due to this the vicinity
of power lines is to be avoided as well.
Cosmed equipment are not AP not APG devices (according to
EN 60601-1): they are not suitable for use in presence of
flammable anaesthetic mixtures with air, oxygen or nitrogen
protoxide.
If not otherwise stated in the shipping documents, Cosmed
equipment have been conceived for operating under normal
environmental temperatures and conditions [IEC 601-1(1988)/EN
60 601-1 (1990)].
• Temperature range 10°C (50°F) and 40°C (104°F).
• Relative humidity range 20% to 80%
• Atmospheric Pressure range 700 to 1060 mBar
• Avoid to use it in presence of noxious fumes or dusty
• Adequate floor space to assure access to the patient during
exercise testing.
• Adequate ventilation in the room.
Chapter 1 - Getting started - 13
Safety and conformity
Safety
IEC 601-1 (1988) /EN 60 601-1 (1990);
Find reported below the complete classification of the device:
• Class I type B device
• Protection against water penetration: IP00, ordinary
equipment unprotected against water penetration
• Non sterile device
• Device not suitable in the presence of flammable
anaesthetics;
• Continuous functioning equipment;
EMC
The system meets the EMC Directive 89/336
EN 60601-1-2
EN 55011 Class B (emission), IEC 1000-4-2, IEC 1000-4-3, IEC
1000-4-4
Quality Assurance
UNI ISO 9001 (Registration n° 387 Cermet)
Medical Device Directive (CE mark)
MDD 93/42/EEC (Notified Body 0476).
Class IIa
14 - microQuark User Manual
Keynotes
Here are the keynotes used to make the manual easier to read.
Typographic keynotes
These are the typographic keynotes used in the manual.
Style Description
Boldindicates a control or a key to be pressed.
“Italic” indicates a messages shown by the firmware.
Graphic keynotes
These are the graphic keynotes used in the manual.
Illustration Description
shows the button to click in the software to
activate the related feature.
Chapter 1 - Getting started - 15
Systems Overview
microQuark is an instrument designed for lung function
screening; the core of the system is the “intelligent” flowmeter
that, connected through the serial port (RS232), turns any
Personal Computer (laptop or desktop) 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.
16 - microQuark User Manual
Before starting
Before operating the microQuark system we strongly recommend
to check the equipment and register you as a customer.
Checking the packing contents
Make sure that the package contains the items listed below. In
case of missing or damaged parts, please contact Cosmed
technical assistance.
microQuark standard packaging
Code Qty Description
C00960-01-04 1 microQuark unit
C02235-01-05 1 Turbine
A 662 100 001 2 Nose clips
C01739-02-35 1 PC Software
C00137-01-20 20 Paediatric paper mouthpieces
C00136-01-20 20 Adult paper mouthpieces
C00063-01-20 1 Conic mouthpiece
C00214-01-20 1 Paediatric adapter
A 362 300 004 1 Serial cable RS232 USB Power
C00067-02-94 1 Registration card
C02268-02-91 1 User manual
C01999-02-DC 1 Conformity declaration
Chapter 1 - Getting started - 17
Warranty registration
Before using the system, please take a moment to fill in the
registration form and the warranty and return them to COSMED,
by doing this you are eligible to the customers assistance service.
For further information, please refer to the enclosed registration
and warranty form. If the form is not enclosed in the packaging,
please contact directly COSMED.
Register the product via software
Together with the PC software, a registration software is
supplied. With this software it is possible to fill in an electronic
form with the customer information.
1. To run the software, double click on the icon Registration or
select Registration… from ? menu.
2. Type the requested information and click Send… to send the
form via e-mail to COSMED.
How to contact COSMED
For any information you may need, please contact the
manufacturer directly at the following address:
COSMED S.r.l.
Via dei Piani di Monte Savello, 37
P.O. Box n. 3
00040 - Pavona di Albano
Rome - ITALY