User's Manual

BiWaze® Clear System - User Manual Page | 1
1 Introduction
1.1. Indication For Use
The BiWaze® Clear System is indicated for the mobilization of secretions, lung expansion therapy, the
treatment and prevention of pulmonary atelectasis, and has the ability to provide supplemental oxygen when
used with an oxygen supply.
Patient Population
The BiWaze Clear System is indicated to deliver therapy to adults and children over the age of 2 years in the
acute care setting.
The BiWaze Clear System is indicated to deliver therapy to adults and children over the age of 5 years in the
home care setting.
1.2. Overview
The BiWaze Clear System helps to mobilize secretions from the lower airways to the upper airways where they
can be coughed or suctioned out of the lungs.
This User Manual includes instructions for setup, use and maintenance of BiWaze Clear. Before you operate
the system, make sure you have read and understand in detail the contents of this manual. It is important that
you read and strictly obey the safety aspects contained in this manual.
This User Manual is applicable for BiWaze Clear and is intended for a patient, caregiver, and medical
professional for all care environments.
Note: ABMRC LLC is the legal manufacturer of BiWaze Clear. ABMRC LLC is part of the corporate group, ABM
Respiratory Care.
1.3. Product Package Contents
The BiWaze Clear System includes the following components.
• BiWaze Clear control unit
• Dual Lumen Breathing circuit kit that includes a bacterial/viral filter, breathing tube, connecter,
handset, handset cap, Aerogen Solo nebulizer, and patient interface (Mouthpiece)
• AC Power Cord
• User Manual
• Quick Reference Guide
• Air inlet filter
• Aerogen Solo Power Cable
• Carry Bag (home care only)
• Mobile Cart (acute / post-acute care only)
Following components are optional accessories that are available for BiWaze Clear
• Other Dual Lumen Breathing circuit kit with patient interface options (face mask-various sizes and
flexible trach adapter)
• SpO2 Oximeter
• SpO2Sensor (size options: small, medium and large )
WARNING
• Use BiWaze Clear only as directed by a physician or healthcare provider.
• Use BiWaze Clear only for the intended use as described in this manual. Advice contained in this
manual does not supersede instructions given by the prescribing physician.
• Read the entire manual before using BiWaze Clear.
• Setup and configure BiWaze Clear in accordance with the instructions provided in this guide.
CAUTION (For USA only)
Federal law restricts this device to sale/use by or on the order of a physician.
1.4. Theory of Operation
The BiWaze Clear System helps to mobilize secretions and provide lung expansion therapy for the treatment
and prevention of pulmonary atelectasis and has the ability to provide supplemental oxygen when used with
an oxygen supply. The airway clearance therapy creates airflow bias which expands the airways and dislodges