Spirolab
Rev.1.8
Page 7 of 60
It is the responsibility of the user to ensure that the product is used and stored under the
proper environmental conditions. For further information, refer to the instructions in
section 1.5.3 below.
WARNING
If the device is subject to climate conditions other than those shown in section 1.5.3,
it is possible that malfunctions may occur and/or that incorrect results may be
displayed.
1.1.4
Individual patient factors that can affect use of the product
The spirometer can only be used when the patient is resting and in good health, or at least
in a state of health that is compatible with the test being carried out. Performing the test
calls for the
collaboration
of the patient, who must exhale forcefully to ensure that the
parameters measured provide reliable results.
1.1.5
Limitations of use
–
Contraindications
An analysis of the results of spirometry alone is not sufficient to provide a diagnosis of a
patient's clinical condition. A diagnosis can only be made in conjunction with an
examination that takes the patient's case history into account, as well as the results of other
tests recommended by the doctor.
Comments, diagnoses and appropriate therapeutic treatments are made by the doctor.
Any symptoms must be evaluated before spirometry is carried out. The doctor who
prescribes use of the device must first ascertain the physical/psychological capacity of the
patient to assess his or her suitability for performing the test. The same doctor must
subsequently evaluate the data gathered by the device to estimate the degree of
collaboration
for each test carried out.
A correct spirometry test calls for a patient's complete collaboration. The results obtained
depend on the patient's ability to inhale and exhale as quickly as possible. If these key
conditions cannot be met, the spirometry results will not be reliable or, as doctors say, will
be "unacceptable". The
acceptability
of a test is the doctor's responsibility. Extra care
must be taken when dealing with elderly patients, children or differently-able persons.
The product must not be used if malfunctions or faults are detected or suspected as these
may compromise results.
WARNING
When the spirolab device is used as an oximeter, it has a limited alarm system and
for this reason the SpO2 and pulse rate shown on the display need to be checked
frequently.
