Intended Use; Contraindications - Trudell Medical International AerobiKA Mode D'emploi

INTENDED USE

The Aerobika* Oscillating Positive Expiratory Pressure Therapy System is intended for use as a Positive Expiratory
Pressure (PEP) device. The Aerobika* Oscillating PEP 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 lpm for 3–4
seconds.
CAUTIONS
• Do not leave the device unattended with children. It is not a toy.
• Do not press attachment tabs when the case is disassembled. Doing so could break the tabs and prevent proper
assembly of the device.
• Ensure contraindications are observed.

CONTRAINDICATIONS

Use of the Aerobika* Oscillating PEP 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
WARNING
Use of this device at excessive pressures may have adverse effects. Expiratory pressures above 20 cm H ² O in patients
sensitive to increased transpulmonary pressure may develop 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 Adjustment 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
SETTING UP YOUR AEROBIKA* OSCILLATING PEP
For device descriptions see Figure 1.
Before use, ensure these instructions have been read and are kept available at all times. If you have questions about the
performance or usability of this product, please contact your healthcare professional prior to use.
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