1.4. Restrictions on use and Contradictions
Any diagnosis of conditions or prescribed treatments should be made only by a qualified
healthcare professional. The healthcare professional should take into consideration the
outcomes of a medical examination, the patient’s clinical history and results of any other tests
deemed necessary, in addition to the test results provided by SpiroClinic Pro.
SpiroClinic Pro 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 SpiroClinic App, so that each user's personal information and test results can be stored and
logged.
A new disposable bacterial viral filter 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,
inability to understand directions or unwillingness to follow the directions of the operator will
usually lead to submaximal test results.
Relative Contraindications for Spirometry;
Due to increases in myocardial demand or changes in blood pressure;
