User's Manual

BiWaze® Clear System - User Manual Page | 2
retained mucus in the lungs and helps treat and prevent atelectasis. BiWaze Clear provides three respiratory
therapies: PEP, OSC, and NEB.
• Positive Expiratory Pressure (PEP): During PEP, the system delivers a programmed positive pressure
which the patient exhales against to open and expand the patient’s airways. The nebulizer can be
configured to run during PEP therapy to help move the medicated aerosol throughout the airways.
• Oscillation (OSC): During OSC, the system oscillates the airways with pulses of positive pressure to
thin secretions and mobilize them from the lower airways to the upper airways so they can be coughed
or suctioned out. The nebulizer can be configured to run during OSC therapy to help move the
medicated aerosol throughout the airways.
• Nebulize (NEB): During NEB, the system powers only the Aerogen solo vibrating mesh nebulizer. This
therapy gives the patient a break from PEP or OSC while the patient receives their nebulized
medication.
1.5. Intended Use
The BiWaze Clear System assists patients in loosening and mobilizing secretions as well as treating and
preventing atelectasis by providing lung expansion and high frequency oscillation therapies. The BiWaze Clear
System may be used with a patient interface like face mask, mouthpiece, a trach adapter to a patient’s
endotracheal or tracheostomy tube, or in line with a ventilator. It is for use on adult or pediatric patients in
acute, post-acute, and home care environments.
1.6. Contraindications
The BiWaze Clear System is contraindicated in patients with the following pre-existing conditions:
Absolute Contraindication
The BiWaze Clear System is contraindicated if this patient condition exists:
• Untreated tension pneumothorax
Relative Contraindication
When you use the BiWaze Clear System, patients with these conditions should be carefully evaluated before
a decision is made to use the therapy:
• History of pneumothorax
• Pulmonary air leak
• Recent pneumonectomy
• Pulmonary hemorrhage
• Myocardial infarction
• Vomiting
Possible Adverse Conditions
When you use the BiWaze Clear System, patients may experience one or more of these effects:
• Hyperventilation
• Gastric distension
• Decreased cardiac output
• Increased intracranial pressure
• Increased air trapping
• Hyperoxygenation
• Pneumothorax
• Pulmonary air leak
• Pulmonary hemorrhage
1.7. General Warnings and Cautions
When using electrical products, especially when children are present, basic safety precautions should always
be followed, including the following important safeguards.
READ ALL INSTRUCTIONS BEFORE USING.
The following are general warnings and cautions. Further specific warnings, cautions and notes appear next
to the relevant instruction in the manual.