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INTENDED USE
The Aerobika* Oscillating Positive Expiratory Pressure
device is intended for use as a Positive Expiratory
Pressure (PEP) device The Aerobika* device may
also be used simultaneously with nebulized aerosol
drug delivery The device is intended to be used by
patients capable of generating exhalation flow of
10 L/min for 3–4 seconds
INDICATION(S)
The Aerobika* Oscillating PEP device is an airway
clearance therapy device used to mobilize excess
lung secretions and improve breathing It can be
used to manage respiratory conditions such as COPD,
bronchiectasis and Cystic Fibrosis
Single patient use only
CONTRAINDICATIONS
Use of the device is not recommended for the
following conditions:
• Patients unable to tolerate the increased work of
breathing
• Intracranial pressure (ICP) > 20 mm Hg
• Hemodynamic instability (blood pressure
instability)
• Recent facial, oral, or skull surgery or trauma
• Acute sinusitis
• Epistaxis (bleeding nose)
• Esophageal surgery
• Nausea
• Active hemoptysis (bleeding from lungs)
• Untreated pneumothorax (untreated collapsed
lung)
• Known or suspected tympanic membrane rupture
or other middle ear pathology
WARNINGS
Use of the device at excessive pressures may have
adverse effects Expiratory pressures above 20 cm
H₂O in patients sensitive to increased transpulmonary
pressure may cause one or more of the adverse side
effects listed below Expert clinical judgment should
be exercised in the selection of the appropriate
setting for each individual patient Failure to match
the appropriate resistance setting on the Resistance
Indicator with the patient's expiratory flow may
result in failure to achieve therapeutic objectives of
oscillatory PEP therapy or one or more adverse side
effects listed below
Adverse reactions may include:
• Increased work of breathing that may lead to
hypoventilation and hypercarbia
• Increased cranial pressure
• Cardiovascular compromise
• Myocardial ischemia
• Decreased venous return
• Air swallowing with increased likelihood of
vomiting and aspiration
• Claustrophobia
• Pulmonary barotraumas
USE INSTRUCTIONS
Before use, ensure these instructions have been
read and are kept available at all times If you have
questions about the performance or use of this
product, please contact your healthcare professional
prior to use For device descriptions see page 1, figure
1
Warning: Do not leave the device unattended
with children Contains small parts that can cause
choking
DEVICE SET UP
The Aerobika* device resistance setting should
be set up by a healthcare professional using the
following steps:
1
Start with the Resistance Indicator at the middle
setting (page 1, figure
2
With the patient in a comfortable seated position,
have them inhale through the device taking a deeper
breath than normal, but not to total lung capacity,
then exhale briskly but not forcefully through the
device
3
Resistance should be set so exhalation lasts for
3–4 times longer than inhalation Resistance can
be increased by moving the indicator to the left To
reduce resistance, move the indicator to the right
Note: Selection of the proper resistance setting will
produce the desired inspiratory:expiratory flow ratio
of 1:3 or 1:4 for 10–20 minutes without excess fatigue
4
Patients should be reevaluated periodically or
with any change in status As airways become
less congested, more resistance will be needed to
maintain inspiratory:expiratory ratios
DEVICE USE
Treatments should be conducted twice daily or as
directed by your healthcare professional Although
the Aerobika* device is orientation independent,
it is recommended that treatments be done in a
comfortably seated position (page 2, figure
1
Carefully examine the device
• If there is any visible dust or other debris inside,
then clean the device Replace immediately if it is
damaged or has missing parts
• Ensure the Resistance Indicator is set as
prescribed by your healthcare professional
• Gently press the two halves together to make sure
the Attachment Tabs are engaged
2
Put the mouthpiece in mouth and close lips around
it to ensure an effective seal Make sure your hand
does not block the exhalation path on the back of the
device
)
3
4
)
3
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