User Manual
SpirolabIII – User’s Manual Code MIR 980067 REV 0 Page 6 / 47
INTRODUCTION
The spirometers series MIR009 are sold with the SpirolabIII trademark.
SpirolabIII is available with two different displays:
• Colour LCD display
• B/W LCD display
Unless otherwise specified, from this point onwards the term SpirolabIII is used to refer to both models.
1 GENERAL INFORMATION
1.1 INTENDED USE
1.1.1 User Category
SpirolabIII, spirometer + oximeter calculates a series of parameters relating to human respiratory function.
The product is therefore intended for use by a doctor or by a trained paramedic or technician, under the supervision of a
doctor.
1.1.2 Ability and experience required
The correct use of the device, the interpretation of the results and the maintenance of the device, with particular
attention on cleaning operations (cross-contamination risk), all require qualified personnel.
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SpirolabIII
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1.1.3 Operating environment
The device has been envisaged for use in a doctor’s office or in a hospital setting.
The information necessary for the proper use of the device in surrounding electromagnetic environments (as required by
EN 60601-1-2) is contained in the Annex.
The device is not intended for use in an operating theatre nor in the presence of inflammable liquids or detergents, nor
in the presence of inflammable anaesthetic gases (oxygen or nitrogen).
The device is not designed to be used in direct air currents (e.g. wind), sources of heat or cold, direct sun rays or other
sources of light or energy, dust, sand or any other chemical substances.
The user and/or the doctor are responsible for ensuring that the device is stored and used in appropriate ambiental
conditions.
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1.1.4 Who can or must make the installation
The device requires installation by qualified personnel. The user shall normally configure the device accordingly.
1.1.5 Subject effect on the use of the device
A spirometry test should only be carried out when the subject is at rest and in good health, and thus in a suitable
condition for the test. A spirometry test requires the collaboration of the subject, since the subject must make a
complete forced expiration, in order to have a meaningful test result.
1.1.6 Limitations of use - Contraindications
An analysis of the results of a spirometry test is not by itself sufficient to make a correct diagnosis of the subject’s
clinical condition. Test comments, a test interpretation and suggested courses of treatment must be given by a doctor.
Any symptoms that the subject has at the time must be carefully considered before a spirometry test is made. The user
is responsible to assess both the mental and the physical capacity of the subject to make a correct test and the user
must also assess the degree of collaboration for each test carried out.
A correct spirometry test requires the complete collaboration of the subject. The results depend on the person’s
capability to inspire and to expire all air completely and as fast as possible. If these fundamental conditions are not
respected then the results obtained during spirometry testing will not be accurate, and therefore the test results are "not
acceptable".
The acceptability of a test is the responsibility of the user. Special attention should be given to testing elderly subjects,
children and handicapped people.
The device should never be used when it is possible or probable that the validity of the results may be compromised due
to any such external factors.