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│Clinic
User Manual
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pulmonary disease and cystic fibrosis. These measurements can be used for the
detection, assessment and monitoring of diseases affecting the lung function.
and should be used by:
-
Healthcare professionals, test operators, physicians, clinicians, occupational health
professionals, etc.
2.4.
RESTRICTIONS ON USE AND CONTRAINDICATIONS
Any diagnosis of conditions or prescribed treatments should be made only by a qualified
healthcare professional who, in addition to the test results provided by Spirohome
®
Clinic,
will take into consideration the outcomes of a medical examination, the patient’s clinical
history and results of any other tests deemed necessary.
Spirohome
®
Clinic is a multi-user device. The device can log the information and test results
that belong to each specific patient. For each new patient, a new patient account must be
created on the Spirohome
®
Clinic app, so that each user's personal information and test
results can be stored and logged.
A new Spiroway Disposable mouthpiece must be used for each new user.
The spirometry test should only be performed by users who do not experience any shortness
of breath and are in good health for performing a lung function test. Test results of patients
who do not meet these conditions may not be reliable. A correct spirometry test depends
greatly on the patient’s ability to correctly perform the expiratory/inspiratory maneuver as
described in this manual. Failure to perform a correct maneuver may lead to inaccurate and
unacceptable results. The device should not be used if the accuracy and reliability of test
results may be jeopardized by external factors.
Performing spirometry can be physically demanding. The forced expiratory maneuver used
in spirometry increases intrathoracic, intraabdominal, and intracranial pressures. Potential
risks of spirometry are primarily related to maximal pressures generated in the thorax and
their impact on abdominal and thoracic organs, venous return and systemic blood pressure,
and expansion of the chest wall and lung. The physical effort required can increase
myocardial demand. Caution must be used for patients with medical conditions that could be
adversely affected by these physiological consequences. Although such risks are likely to be
minimal for spirometry in most patients, the potential risks associated with testing should
always be weighed against the benefit of obtaining information about lung function.
Spirometry should be discontinued if the patient experiences pain during the maneuver.
Patients with potential contraindications that would prevent testing in the primary care setting
may be tested in a pulmonary function laboratory where operators are more experienced
and there may be access to emergency care if needed. Furthermore, because spirometry
requires the active participation of the patient, the inability to understand directions or
unwillingness to follow the directions of the operator will usually lead to submaximal test
results.
First Pub. Date: 24.09.2018
R.9-1 / 10.03.2020
