The BiWaze® Clear System is a medical device designed for airway clearance, providing oscillating lung expansion (OLE) therapy to help loosen mucus, decrease inflammation, and open airways, facilitating easier breathing. It combines lung expansion therapy with high-frequency oscillation and aerosol therapy to mobilize secretions and deliver medication deep into the lungs, maximizing therapy effectiveness.
Function Description:
The BiWaze® Clear System works by expanding and clearing the airways through a combination therapy in just 10 minutes. It utilizes alternating therapies of lung expansion and high-frequency oscillation, which, when combined with aerosol therapy, helps to mobilize secretions and deliver medication effectively. This approach addresses the vicious cycle of lung infections where inflamed and weak airways lead to mucus buildup, bacterial growth, and damage, ultimately causing chronic respiratory failure and other serious health complications. Airway clearance techniques (ACTs) like those provided by BiWaze® Clear loosen thick, sticky mucus, allowing it to be cleared from the lungs by coughing, thereby reducing the likelihood of infections and improving breathing.
Important Technical Specifications:
The BiWaze® Clear System consists of a main therapy control unit and a Dual Lumen Breathing Circuit. Key components include:
- BiWaze Clear Main Therapy Control Unit: The central unit that manages the therapy.
- Touch Screen: Allows users to view settings, system status information, therapy settings, and logs. It also enables modification of settings.
- Device Mode LED Light: Provides different color codes for various modes: Green for Manual Mode, Blue for Auto Mode, and Red for Error or Shutdown Mode.
- Patient Port: Connection point for the Dual Lumen Breathing Circuit.
- Air Inlet Filter: Filters air entering the control unit.
- Cooling Fan: Cools the main control board.
- Power Switch: Turns the control unit on and off.
- AC Power Inlet: Connection port for the AC power cord to power the control unit and charge the battery. A red light indicates if the power cord is fully connected.
- Handle: For easy carrying of the control unit.
- Aerogen® Power Port: Connection port for the Aerogen controller cable, which powers the Aerogen Solo nebulizer.
- HDMI Port: Allows external display of the touch screen through an HDMI cable.
- USB Ports: Connection port for USB flash drives and SpO2 external sensors.
- Coaxial Bacterial/Viral Filter: Designed to filter bacterial and viral particles flowing in and out of the control unit.
- Coaxial Breathing Tube: Separates the inhalation (outer path) from the exhalation (inner path).
- Aerogen® Power Cable: Powers the Aerogen Solo nebulizer.
- Aerogen® Solo Nebulizer: A vibrating mesh nebulizer for prescribed medication.
- Handset: Provides a comfortable grip for therapy delivery and a spacer for the nebulizer.
- Patient Interface: Various options available, including face mask, mouthpiece, and a flexible trach adapter.
Usage Features:
The BiWaze® Clear System offers both Auto and Manual therapy modes.
System Setup:
- Assemble the Dual Lumen Breathing Circuit.
- Switch on the power at the back of the control unit and plug in the AC power cable.
- The control unit self-calibrates during startup.
- The screen displays the last therapy completed. Different therapy options can be selected from the drop-down list under Auto mode.
- Position the control unit on a firm, flat surface within arm's length of the patient. Ensure air inlet areas are not blocked.
Therapy Screen:
The therapy screen provides comprehensive information and controls:
- Lock Icon: Indicates if the screen is locked (blue) or unlocked (grey).
- Patient Name or ID: Optional field.
- Therapy Modes: Auto Mode (pressures and times are preprogrammed) and Manual Mode (pressures are set and therapy time is controlled by the user).
- WiFi Data Transmission: Allows data transmission to Arc Connect and data/time synchronization.
- Battery Status: Displays current battery level.
- Date and Time: Shows current date and time.
- Pressure Manometer: May be hidden.
- Peak Pressure: May be hidden.
- Progress Circles: Track current phase and next phase of therapy.
- Start or Pause Icon: Initiates or pauses therapy.
- Settings: Accesses system settings.
- Edit Therapy: May be hidden.
- Therapy Time: Displays remaining therapy duration.
Run Therapy (Auto Mode):
- Select "Auto" from the top menu bar. Pre-programmed therapy options are available.
- Ensure the patient interface is securely in place. This may involve a face mask (tightly, comfortably, covering mouth and nose), a mouthpiece (lightly in the patient's mouth, with a tight seal), or a flexible tracheostomy adapter.
- Press "Start" to begin therapy.
- Use the therapy timer (A) and phase circles (B) on the screen to follow along with the therapy.
- To halt therapy, press "Pause."
- To resume therapy or end it, press "Resume Therapy" or "End Now." Note: Therapy will remain in a pause state for 5 minutes before automatically ending.
- Upon completion, a "Therapy Completed" ribbon appears across the screen.
Typical Therapy (Manual Mode):
A typical therapy session is 10 minutes, expanding airways and moving secretions. It consists of 2.5 minutes of PEP (positive expiratory pressure), 2.5 minutes of OSC (high frequency oscillation), repeated twice for a total of 10 minutes. The Aerogen® Solo can be run with saline while using BiWaze® Clear.
Inspiratory Trigger:
Clinical teams can enable "allow user adjustments" to modify programmed therapy profiles. If enabled, therapy pressure can be adjusted up to 5 cmH2O per phase. When a therapy is adjusted, the device will reset to the original saved therapy profile settings after the therapy is run. The pen icon indicates if the ability to adjust pressure is visible. Press the pen icon to open the therapy settings. From the therapy settings screen, phases in the therapy line can be edited. The edit phase settings box allows adjustment of pressure based on what has been enabled by the clinician.
Maintenance Features:
Cleaning and Maintenance:
Control Unit and Breathing Circuit:
- Switch off and unplug the power cord from the control unit.
- Disconnect the breathing circuit from the control unit.
- Wipe the exterior of the control unit, patient port adapter, and power cord with an approved cleaning agent (refer to the BiWaze Clear User Manual BK0381 for a list).
- Allow the device to dry completely before plugging in the power cord.
- Disconnect all components of the Dual Lumen Breathing Circuit (coaxial viral/bacterial filter, coaxial breathing tube, handset, and patient interface).
- Examine the coaxial viral/bacterial filter; discard if damaged, sputum-trapped, or moist. If intact, gently wipe the exterior with an approved cleaning agent and set aside. Do not wash the filter.
- The coaxial breathing tube, handset, and patient interface should be washed thoroughly with liquid dishwashing soap and warm water.
- Let the components air dry completely before reuse.
- Replace the breathing circuit after 30 days or 90 therapy cycles, whichever comes first.
Preventative Maintenance:
BiWaze Clear does not require routine servicing. The system performs a self-calibration upon every startup.
Air Inlet Filter:
Under normal usage, the air inlet filter should be cleaned at least once a month and replaced every six months. If BiWaze Clear is used in an environment with high dust or animal hair, clean the filter more frequently.
- Switch off and unplug the power cord.
- Remove the filter from the enclosure by pinching it with fingers.
- Examine the filter for integrity; replace if torn or damaged.
- Wash the filter in warm water with a mild detergent like liquid dish soap.
- Rinse thoroughly to remove all detergent residue.
- Reinstall the filter after it is completely dry.
Note: Only Air Inlet Filters (BC21274) from ABM Respiratory Care should be used as replacement filters. The filter package includes 3 filters, but only one is used at a time.
Storage and Transportation:
Store in a dust-free location out of reach of children. Use the carrying bag provided to protect the control unit and accessories during travel. The carrying bag is for carry-on luggage only and will not protect the system if it is put through checked baggage. Do not place other baggage on top of the system.
This Patient Guide contains information extracted from the BiWaze Clear user manual (BK381). For complete instructions, refer to the BiWaze Clear user manual. For questions about the BiWaze Clear system or therapy, contact your local Home Health Equipment company or healthcare team.