USER MANUAL BK0381 Rev: 5.
Contents 1 Introduction .......................................................................................................................... 1 1.1. Indication For Use ............................................................................................................. 1 1.2. Overview ............................................................................................................................. 1 1.3. Product Package Contents................................................
6.4 Administrator Section .................................................................................................... 23 6.5 Wi-Fi Configuration ......................................................................................................... 27 6.6 Date and Time Configuration ........................................................................................ 28 6.7 SpO2 Configuration ...............................................................................................
12. EMC Information ................................................................................................................38 12.1 Electromagnetic Emissions........................................................................................... 38 12.2 Electromagnetic Immunity ............................................................................................ 39 12.2.1 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and This Device ..............
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.
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.
WARNING Obey all warnings throughout the manual and also those below to help prevent injury and/or equipment damage. A WARNING alerts you to possible injury. The operator should read and understand this entire manual before using the device. • WARNING - Federal USA law restricts this product to sale by or on the order of a physician. Sale by or on the order of unauthorized persons can cause patient injury.
• • • • • • • • CAUTION - Keep the power cord and device away from any potential heat sources like room heater, hot iron, kettle steam etc. CAUTION - Make sure that all the air inlets on the side of the device are unobstructed. If the device is placed on the floor, make sure the area is free from dust and clear of bedding, clothes, or other objects that could block the air inlets. CAUTION - Do not operate the device in direct sunlight for better visibility and avoid heating the LCD screen.
Unique Device Identification Consult Instruction for Use *The year of manufacture is written under this symbol on the BiWaze Clear device. The following acronyms are used in BiWaze Clear. Acronym Meaning PEP OSC SpO2 HR NEB B/V Filter Positive Expiratory Pressure Oscillation Blood Oxygen Saturation Heart Rate Nebulizer Bacterial and Viral Filter 2. BiWaze Clear System Overview 2.1.
2.2.3.
3. Assemble The Dual Lumen Breathing Circuit WARNING - Do not operate the system without B/V filter WARNING - Do not apply excessive force to assemble or disassemble the Dual Lumen Breathing Circuit to avoid damage to the components. • WARNING - Always use a new Dual Lumen Breathing Circuit when using the system on a new patient to avoid cross-contamination. • WARNING - Do not sterilize the circuit for reuse.
• Trach Adapter i. Connect the handset (C) to the flexible trach adapter (G) ii. Connect the other end of the flexible trach adapter to the patient’s tracheostomy tube 3.2. Connect to an Oxygen Source To prevent injury or equipment damage, read these warnings before assembly • WARNING - Always use a new Dual Lumen Breathing Circuit when using the system on a new patient to avoid cross-contamination. • WARNING - Do not connect the system to an unregulated or high-pressure oxygen source.
3.3.1 Connect Controller Cable 1. Follow the steps in Section 3.1 Connect the components 2. Insert Aerogen® Solo nebulizer (D) to the nebulizer port of the Handset (C) 3. Connect the flat end of the Aerogen® Solo Controller Cable into the Aerogen® Solo (D) nebulizer 4.
For intermittent doses less than or equal to 6 mL: 1. Open the medication port cap on the Aerogen® Solo 2. Use a pre-filled ampoule or syringe to add medication into the filler port of the Aerogen® Solo 3. Close the port cap Note: Medication can be added to the Aerogen® Solo during therapy. 3.4.
4.3 Power Source Indicators Power source indicators are presented on the control unit and the display screen. These indicators are described in detail below. 4.3.1 AC Power Indicators When AC power is applied to the control unit, a red LED indicator is illuminated next to the Master Switch. If the display screen is on, a charging indicator icon appears on the battery symbol located on the top menu bar.
I J K L Therapy section displays information about the therapy being delivered. Play / Pause icon allows the user to start and pause the therapy. Device Settings icon allows the user to make some configuration changes, view log files and access administrative screens. Edit icon allows the user to edit Auto Therapy. This icon is only visible for Auto Therapy Mode and if the software is unlocked or Allow User Adjustment is enabled in Lock Device Options. 5.
CAUTION - Ensure the Breathing Circuit and the Patient Port are dry before delivering the therapy. 1. Ensure the BiWaze Clear control unit and Dual Lumen Breathing Circuit are setup per the instructions in Section 3 Assemble Dual Lumen Breathing circuit and Section 4 Power On and Off the Control Unit. 2. Select Auto from the top menu bar. You will notice the Therapy Mode Light around the Play/Pause button will turn blue 3. Ensure the patient interface is in place on the patient. a.
8. When the therapy is complete, a ribbon will be displayed across the screen. 8.1. Press the to view the therapy summary. 8.2. Press the on the left to close the ribbon. 5.2.1 Edit Auto Therapy Auto therapy can be edited if the system is unlocked or if Allow User Adjustment is enabled under Lock Options. Typically, healthcare providers will lock the software when BiWaze Clear is used in the home environment.
Steps to edit Auto Therapy: 1. Press the Pen icon (A) to enter the edit auto therapy. 2. You will see three therapy phases options (B) across the top of the screen. The therapy line across the middle represents the phases of therapy that will delivered. 3. To add a therapy phase to the therapy line, press the phase you want to add from (B) and drag it into the therapy line (C). 4.
Note: The total number of phases (F) in the therapy line and the total therapy time (G) of all the phases is on the bottom left. 6. When the therapy settings are edited to match the prescription, press the green checkmark (H) to save and close. 7. The therapy can be saved as a Profile. See Section 6.2 Therapy Profiles for instructions on how to create a Profile. 5.3 Manual Therapy Note: • Always use the therapy settings prescribed by the physician.
6. Press the Play button to engage the blowers for therapy. 7. Press the therapy phase you want to deliver PEP, OSC or NEB. You will know which phase is running because the circle will glow, and the timer will begin counting under the circle. • You can deliver NEB with either PEP or OSC, otherwise NEB can be delivered as a stand-alone therapy phase. The NEB will glow blue when it is running. • If NEB is running and you want it to stop delivering the nebulizer, press the NEB circle.
10. Once the therapy is running, the therapy can be paused at any time by pressing the Pause button or the Therapy Mode Light. Note: The therapy can be paused for 5 minutes. A countdown timer will appear on the screen. You can choose to resume therapy or end therapy. If the timer reaches 5 minutes the therapy will automatically end. 11. When you have completed the Manual therapy, press the Pause button and then select END NOW. 12.
8. When Manual Therapy is programmed, the therapy can be saved as a profile, see Section 6.1.2 Save Profile or deliver the therapy. To deliver Manual therapy See Section 5.3.1 Deliver Manual Therapy for instructions. 6. Device Settings 6.1. Device Info Screen The Device settings screen appears after you press the settings icon when the system is not delivering therapy.
6.2 Therapy Profile 6.2.1 Save Therapy Profile 1. Once a therapy is entered into either Auto or Manual Mode, the settings can be saved as a Profile. 2. Press the Device Settings icon . 3. Press the Save Profile button. 4. Enter the name of the Profile, up to 11 characters. 5. Press Confirm to save the Profile. Note: The system can save up to 10 Profiles between Auto and Manual therapy modes. 6.2.2 Remove Therapy Profile To remove a therapy profile: 1. Select the profile you want to remove 2.
6.3 Device Logs Screen The device logs contain information about therapies performed and system related events. 6.3.
6.3.2 Monitoring Logs 6.3.
6.4 Administrator Section The Administrator section is password protected and only trained users can access this section. The following settings are available within the Administrator section. 6.4.1 Remote Server Settings CAUTION - Do not change the Remote Web Server URL Remote Web Server URL is the address to Arc Connect. NTP Server Address is set within the software but it can be configured to a different server if one is entered into this field.
2. Insert a USB thumb drive in either of the two available slots in the control unit. 3. Once the software detects the USB, you will see USBDevice1 appear on the screen. Press on USBDevice1. 4. Press the Download button to save the encrypted therapy log file to the USB. 5. Once the download is complete, you’ll see a notification stating the file was successfully downloaded. You can remove the USB thumb drive. 6.4.
5. Once the download is complete, you’ll see a notification stating the file was successfully downloaded. You can remove the USB thumb drive. 6.4.4 Restore Device Settings This option allows you to upload device settings from another BiWaze Clear. 1. Select a tab with the USB icon. 2. Insert a USB thumb drive in either of the two available slots in the control unit. 3. Once the software detects the USB, you will see USBDevice1 appear on the screen. Press on USBDevice1. 4.
6.4.5 Reset Settings You can reset BiWaze Clear to the factory default settings or only the hour meter reading. 1. Press the tab with an arrow in a circle icon 2. Press the Reset All button to reset all settings to the factory default or Reset HMR button to only reset the Hour Meter Reading. 3. Press “Yes” to proceed further with the reset. a. If you reset to factory defaults, a confirmation will appear once the reset is complete. b.
6.5 Wi-Fi Configuration WARNING - Connecting the control unit to public or unknown networks could result in unidentified risks. 1. Press the WI-FI icon on the top menu bar. 2. Press the toggle to turn on the WiFi search. The toggle will be blue when the control unit is searching for a Wi-Fi network. 3. Select the Wi-Fi network. 4. Enter the password.
5. Press Connect. 6. Once the Wi-Fi network is connected, the connected network name will appear under Current Network. 6.6 Date and Time Configuration Note: If connected to a WI-FI network, the date and time will be updated automatically based upon the network location and the selected time zone. 1. Press the Date and Time on the top menu bar. 2.
3. Select the appropriate day, month, and year by highlighting the parameter and using the arrow keys to adjust to the correct value. 4. Press the green checkmark to save the date. 5. Press Time 6. Select the appropriate time parameters including: a. AM or PM b. 12 hr vs 24 hr clock c. Hours and Minutes 7. Press the green checkmark to save the time.
8. Press the X on the top right to close the date and time window. 6.7 SpO2 Configuration BiWaze Clear is validated with the Nonin SpO2 sensor with USB Connector. The information collected via the external sensor is displayed on the main screen during therapy. To connect the Nonin SpO2 sensor to BiWaze Clear: 1. Connect the finger sensor cable to the USB controller cable. 2. Connect the USB controller cable to one of the two USB ports located on the side panel of BiWaze Clear. 3.
7. Locking and Unlocking Feature 7.1 Lock Feature When the software is locked, display settings and therapy adjustment can be restricted. This mode is suitable for home users who are with minimal medical training and basic knowledge of the product. This mode is mainly intended for providing limited access to prevent risk of inappropriate therapy delivery. Note: It is recommended to Lock the software when used in the home environment.
3. Edit the Lock Device Options by checking or unchecking the appropriate parameters. When a parameter is unchecked, it is not visible or Off. When a parameter is checked it will be visible or On when the system is locked. 4. Press SAVE. Note: When the software is locked, therapies can't be edited unless Allow User Adjustment is enabled. This option allows the user to adjust pressures and time within the range set under the Administrator screens. 7.
Unplug the control unit and clean the front panel and exterior of the enclosure (excluding Dual Lumen Breathing Circuit) as needed. You can also clean the power cable when it is not plugged in. Use one of the following cleaning agents: • A clean cloth dampened with water and a mild detergent • 70% Isopropyl alcohol or similar alcohol based towelettes used for medical devices with less than 70% Isopropyl alcohol • 10% Chlorine bleach solution Inspect the control unit and power cord for damage after cleaning.
8.4 Cleaning the Aerogen® Solo The Aerogen® Solo Nebulizer is single patient use only and is not intended to be cleaned, disinfected or sterilized. 8.5 Storage and transportation 8.6 Traveling with BiWaze Clear While not in use cover the patient port with the cap provided at the port. Power off the control unit and remove the power cable. Store in a dust free location outside the reach of children. When in the home environment, use the carrying bag to transport or store the control unit.
Modes Manual & Auto Manual & Auto Manual & Auto Auto PEP Therapy Parameter Pressure Nebulization Duration Modes Manual & Auto Manual & Auto Auto NEB Therapy Parameter Duration MCB OSC Therapy Parameter Pressure Nebulization Frequency Duration Touch Screen Display 11.1 Product Specification PNEUMATIC MODULE UIB UI Control Board (UIB): This board controls the user interface including the main touch screen LCD as well as USB, and HDMI ports.
Performance may vary depending upon the type of drug and nebulizer used. For additional information contact Aerogen® Solo or drug supplier. The temperature of the medication will not rise more than 10°C (18°F) above ambient during normal use. Note: Above table shows the results of aerosol performance testing for the Aerogen® Solo using an 8-stage cascade impactor running at a continuous flow rate of 28.3 LPM. Indicated ranges correspond to confidence intervals with a confidence level of 95%.
BK0289 BC21095 BK0388 BK0386 BK0381 BC20116 BC22506 BiWaze® Clear Dual Lumen Breathing Circuit – Adult Small Face Mask BiWaze® Clear Dual Lumen Breathing Circuit – Adult Child Face Mask Battery Quick Reference Guide Quick Reference Guide User Manual Power Cord Mobile Cart (Acute Care Only) BC21083 BC21274 BK0371 BK0373 BK0372 BK0374 Carrying Bag Air Inlet Filter (Pack of 3) SPO2 pulse oximeter SpO2 soft sensor small SpO2 soft sensor medium SpO2 soft sensor large BK0291 Coaxial filter, Coaxial breathin
Transmit Power 1Mbps: 17.4 dBm (Typ) 54 Mbps: 13.8 dBm (Typ) MCS7 (20MHz): 12.6 dBm (Typ) MCS7 (40MHz): 11.3 dBm (Typ) Receive Sensitivity 1Mbps DSSS: -96.3 dBm (Typ) 54 Mbps OFDM: -74.9 dBm (Typ) MCS7 (20MHz): -72.4 dBm (Typ) MCS7 (40MHz): -67.0 dBm (Typ) Security Authentication/Encryption Wi-Fi-protected access (WPA and WPA2.0) and IEEE Std 802.11i (includes hardware-accelerated Advanced Encryption Standard [ AES ]) 11.9 Control Accuracy Parameter Accuracy Pressure ± 5 cmH2O Time ± 0.
RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/Flicker emissions IEC 61000-3-3 Class B Class A Complies function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies building used for domestic purpose. 12.
150 kHz to 80 MHz Radiated RF IEC 61000-4-3 6Vrms in ISM bands between 150KHZ to 80MHz 10 V/m 80 MHz to 2.7 GHz 6 Vrms 10 V/m Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance: d = 1.2ÖP d = 1.2ÖP 80 MHz to 800 MHz d = 2.3ÖP 800 MHz to 2.
12.3 Electromagnetic Immunity to Wireless Communications Equipment BiWaze Clear is intended for use in the electromagnetic environment specified below. The customer or user of the device should make sure is used in such an environment.
Control unit does not power up Battery may be too low. Technical errors with an error code number on a Red strip on the LCD Screen and control unit shuts down after few seconds Technical errors with an error code number on a Red strip on the LCD Screen and control unit does not shut down. User cannot start the therapy. Information with a selfexplanatory message on the LCD screen in an Orange strip. Control unit not performing as intended. Making abnormal sounds or therapy performance.
21 High Leak Detected 100000 22 23 24 25 26 27 Mask Off Detected Low Battery Temperature Low MCB Temperature Low Patient Air Temperature PMB and MCB Communication Error Battery Charging Error 200000 400000 800000 1000000 2000000 4000000 28 29 30 31 UIB and MCB Communication Error Low Battery Critical Low Battery High Ambient Temperature Error 8000000 10000000 20000000 40000000 32 Stepper Value Slip Error 80000000 14.
Do not modify this equipment. No modification of this equipment is allowed by any unauthorized personnel. • Replacement of consumables can be performed with standard tools only if required by an authorized service personnel. Note: If a user and/or patient has a serious incident involving BiWaze Clear, immediately contact ABM Respiratory Care. • 15.1 Expected service life 15.2 FRU and Spare parts 15.3 Planned Maintenance 15.
ABMRC LLC 860 Blue Gentian Road Suite 200 Eagan, MN 55121 USA www.abmrc.com BK181 URM 1463077491-381 BK0381 Rev: 5.0 Issue Date: Dec 2022 UI Software Version Above 1.X.
