- children (over the age of 5), adolescents or adults who have been diagnosed with a
chronic pulmonary disease including, but not limited to, asthma, chronic obstructive
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.
1.4. 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 SpiroClinic Compact will
take into consideration the outcomes of a medical examination, the patient’s clinical history and
results of any other tests deemed necessary.
SpiroClinic Compact 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 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,
