BiWaze Cough - User Reference Manual
9
neuromuscular deficits or severe fatigue associated with intrinsic lung disease. This device
is intended for use in hospital, institutional setting or in home on adult patients and
pediatric patients 3 years old and up.
1.2
Contraindications
The BiWaze Cough device is contraindicated in patients with the following pre-existing
conditions:
•
known susceptibility to pneumothorax or pneumo-mediastinum
•
severe bullous lung disease
•
recent barotrauma
1.3
General Warnings and Cautions
The following are general warnings and cautions. Further specific warnings, cautions and
notes appear next to the relevant instruction in the manual.
WARNING
A
warning
alerts you to possible injury.
•
The operator should read and understand this entire manual before using the device.
•
The BiWaze Cough device is a restricted medical device intended for use by qualified,
trained personnel under the direction of a physician.
•
The BiWaze Cough device is not intended to be operated by persons (including
children) with reduced physical, sensory or mental capabilities without adequate
supervision by a person responsible for the patient's safety.
•
If you notice any unexplained changes in the performance of this device, if it is making
unusual or harsh sounds, if the device or the power supply are dropped or
mishandled, if water is spilled into the enclosure, or if the enclosure is broken,
discontinue use and contact your home care provider.
•
Device shall not be operated on a patient without a Bacterial/Viral (B/V) filter along
the Breathing Circuit.
•
Always use a new bacterial filter when using the device on a new patient.
•
Always check time and pressure settings before each treatment.
•
Soreness and/or pain in the chest from a pulled muscle may occur in patients using
the BiWaze Cough for the first time if the positive pressure used exceeds pressures
which the patient normally receives during Positive Pressure Therapy. Such patients
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