account is removed from the app and a new user account is created for the new user.
The device must also be cleaned and disinfected according to the information given in
this user manual before use by a new user.
c. A SpiroWay Reusable mouthpiece must not be shared between users, including family
members. A new mouthpiece must be used for a new user.
d. The PEF & FEV1test should only be performed by users who do not experience any
shortness of breath and are in good health for performing the test. Test results of
patients who do not meet these conditions may not be reliable. A correct PEF & FEV1
test depends greatly on the patient’s ability to correctly perform the expiratory 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.
e. Performing PEF & FEV1can be physically demanding. The forced expiratory maneuver
used in PEF & FEV1increases intrathoracic, intraabdominal, and intracranial pressures.
Potential risks of PEF & FEV1tests 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 PEF & FEV1in most
patients, the potential risks associated with testing should always be weighed against
the benefit of obtaining information about lung function. PEF & FEV1should 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 PEF & FEV1requires the
active participation of the patient, inability to understand directions or unwillingness to
follow the directions of the user manual and SpiroHome App will usually lead to
submaximal test results.
Relative Contraindications for PEF & FEV1test;
Due to increases in myocardial demand or changes in blood pressure;
➢Acute myocardial infarction within 1 wk
➢Systemic hypotension or severe hypertension
➢Significant atrial/ventricular arrhythmia
➢Non-compensated heart failure
➢Uncontrolled pulmonary hypertension
➢Acute cor pulmonale
