PRTN-2037351818-1888 1.0 BiWaze Cough User Reference Manual UI Software version 1.
BiWaze Cough - User Reference Manual 2
Accessing Unlock Mode WARNING The information on this page is ONLY for home care providers. Remove this page from the manual before giving the manual to the patient. Lock & Unlock Modes The device has operation modes as follows; Unlock Mode: In this mode, all therapy setting/controls are unrestricted to the user. This mode is primarily used by clinicians or advanced users with extensive training and relevant respiratory knowledge.
Table of Contents 1 Introduction ..................................................................................................................... 8 1.1 Intended Use ......................................................................................................................................... 8 1.2 Contraindications ................................................................................................................................ 9 1.3 General Warnings and Cautions .......
4.3.1 4.3.2 4.3.3 4.4 4.4.1 4.4.2 4.4.3 4.4.4 Using AC Power .............................................................................................................. 23 Internal Battery ................................................................................................................ 24 Device Power Source Indicators ............................................................................ 24 Setup Therapy Modes.........................................................................
9.1 Cleaning the Device ....................................................................................................................... 44 9.2 Cleaning and Replacing the Air Inlet Filter....................................................................... 45 9.3 9.3.1 9.3.2 Cleaning the Patient Circuit....................................................................................................... 45 Institutional (Hospital) Use ..........................................................
12.9 Sound ...................................................................................................................................................... 59 12.10 Disposal ................................................................................................................................................. 59 12.11 Essential Performance ................................................................................................................... 59 13 EMC Information...........
1 Introduction The BiWaze™ Cough device helps to clear bronchopulmonary secretions from the respiratory system by providing a therapy which mimics a cough. The therapy consists of three phases which mimic a cough; inhale, exhale, and pause phase. The inhale phase is positive airway pressure to expand the lungs. Then exhale phase is a sudden shift to negative pressure to pull the air out of lungs.
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.
• • • • • • • should start at a lower positive pressure during treatment, and gradually increase the positive pressure used based on patient tolerance and comfort. Do not use the device in the presence of a flammable anesthetic mixture in combination with oxygen or air, or in the presence of nitrous oxide. Therapy should not be initiated while the device is in Carry Bag. Do not remove the top cover or disassemble the device as there no serviceable parts inside.
2 BiWaze Product Overview The BiWaze Cough system may include the following components. Some components are optional accessories that may not be packaged with the device. Product Package • BiWaze Cough Device • Standard Patient Circuit Adaptor, Standard Patient Circuit, bacterial filter, 6 ft (1.83 m) flexible tubing, and a Patient interface.
corrugated breathing tubes (standard and custom types), B/V filter, end adapters, and with either the mouthpiece, face mask or an adapter to a tracheostomy or endotracheal tube as the final patient interface. 2.1.1 Expected service life The service life for various subsystems is as follows: Main Device 5 Years Breathing Tube Adaptors and 5 Years power cords Patient Breathing tubes 30 days after unpacking Carry Bag 2 years Batteries 1 year 2.1.
3 Device Mode LED Light This LED light provides different color code lights. Green: Manual Mode Blue: Auto Mode Red: Error or shutdown Mode 2.1.3 Back Panel Interfaces The items numbered in the illustration below are described in the table that follows. 1 2 3 Item 1 2 3 2.1.4 Handle Power source cut off switch AC Power Inlet Description Handle to carry the device Cuts off AC mains and Batter power to main processor. Connect the AC power cord here.
1 4 2 6 3 5 Device Right Side Device Left Side 1 7 Item Foot Pedal port Description Connection port for Foot Pedal 2 HDMI port External HDMI display can be connected here 3 USB ports 4 Air outlet USB memory sticks and SPo2 connectors are connected here This is the outlet port for expiratory air 5 Power supply cooling Cooling fan is located here Fan location 6 MCB Fan Fan with main control board 7 Air Inlet Filter This is the inlet port for inspiratory air CAUTION: Don’t not attac
1 Item Battery housing Description Internal battery is placed here WARNING: Do not open the battery cover, only authorized service personal can open and replace the battery. Do not try and use any other batteries, other than supplied by ABM. 2.2 Symbols The following symbols appear on this device. Consult accompanying instructions for use AC Power Remote Control USB Connector Type BF Applied Part Class II (Double Insulated) Power On/Power Off Protected against solid objects over 12.5mm (e.g.
Date of Manufacture Catalogue Number Authorized representative in European community Product serial number FCC marking Prescription device Manufacturer CE Marking Caution Warning 2.3 Traveling with the System It may be helpful to bring this manual along with you to help security personnel understand the device.
If you are traveling to a country with a line voltage different than the one you are currently using, a different power cord or an international plug adaptor may be required to make your power cord compatible with the power outlets of the country to which you are traveling. 2.4 How to Contact ABM Respiratory Care To have your device serviced, contact ABM Customer Service department at +1 843 830 2233 or info@abmrespiratorycare.com. The device does not have any serviceable parts while in use.
1. 2. 3. Positive pressure at the Inhale Pressure setting for the duration of the Inhale Time setting. Negative pressure at the Exhale Pressure setting for the duration of the Exhale Time setting. Pause pressure for the duration of the Pause Time setting. When the Inspiratory Trigger feature is enabled, Auto mode delivers pressure in the following sequence, repeating the sequence until user pauses & exits the therapy or the number of cycles count is reached: 1. 2. 3.
When inspiratory trigger is enabled, the Pause Time setting is disabled, and the user cannot adjust the Pause Time setting. 3.2.2 Oscillations The Oscillation therapy feature delivers an oscillatory therapy based on Frequency and Amplitude settings. Use of the oscillation feature enhances mobilization and improves bronchial drainage. The oscillations will be least apparent to the patient with lower amplitude and higher frequency settings.
4.2.1 Standard Patient Circuit kit Standard Patient Circuit kit comprise of: a. Standard patient circuit adaptor for a b c “Standard Tube to Device” connection b. Standard bacterial filter c. Optional 22mm “tube to patient interface” connector. d d. Standard 6 feet long, 22 mm diameter single tube Setting Standard Patient circuit for Therapy Step 1.
Please note: The BiWaze custom filter has word “BiWaze” on it while standard filter does not. Standard bacterial filter BiWaze special bacterial filter P Step 4. Attach the patient circuit tube to the bacterial filter Step 5. Attach the patient interface (mask or mouth piece) to other end of the tube. Use appropriate adaptors between tube and patient interface if needed. 4.2.
Custom Patient Circuit kit comprise of: a b a. BiWaze Special Bacterial filter b. Optional 22mm “tube to patient interface” connector. c. 6 feet long, coaxial tube c Setting BiWaze special Patient circuit for Therapy Step 1. Identify the Patient circuit Kit: If the patient circuit tube is a dual coaxial with tube inside the outer tube, its BiWaze special patient circuit tube. Step 2. Ensure that No adaptor is attached to the device and coaxial port is visible. Step 3.
Refer to the instructions included with the patient circuit for more information. Note: BiWaze Coaxial Patient circuit can also be used with any standard Filter at patient end with appropriate connector. 4.3 Supply Power to the Device The device can operate on external AC power and built in Batteries when charged. 4.3.1 Using AC Power An AC power cord is included with the device. 1. Plug the socket end of the power cord into the AC inlet on the back of the device. 2.
4.3.2 Internal Battery ABM offers an internal Lithium-ion battery pack for the device. Please contact your sales support or health care provider for battery replacement. Internal Battery can power the device with active therapies for up to 1 hour* on full charge or equivalent to four 15 minutes therapies. *subjected to default settings, the actual run time can vary depending on age of the battery, settings and actual active therapy time.
4.3.3.2 Battery Level Indicators When the battery is connected to the device, battery symbols will appear on-screen to indicate the battery status. The shading in the battery icon indicates the power remaining in the battery. 4.4 Setup Therapy Modes 4.4.1 Manual Therapy Mode If Manual mode is selected, complete the following steps (see section 4.4.4 for information on accessing therapy modes and profiles): 1. Attach the appropriate patient interface to the device. 2.
10. After the therapy is completed, disconnect the patient from the device, and clear secretions that may have become visible in the mouth, throat, tracheostomy tube, or endotracheal tube. 11. Repeat as advised by your clinician. 4.4.2 Auto Therapy Mode If Auto mode is selected on the main screen, complete the following steps (see section 4.4.4 for information on accessing modes and profiles): 1. Attach the appropriate patient interface to the device. 2.
User can select available profiles under each mode (Auto/Manual) from the top ribbon Mode/Profiles drop downs. 5 Starting and stopping the therapy Caution: Ensure that the Patient circuit and the patient port are dry before using the device on the patient. • User can start the therapy by touching the “Start Therapy” Button on the main screen. • User can pause the therapy by touching the “Pause Therapy” Button on main screen while therapy is ongoing.
Note: If user does not resume or terminate the therapy from Paused state, the system automatically terminates the therapy after timeout. 6 Viewing and Changing Settings 6.1 Navigating the Menu Screens Navigation for all the menu screens is through main touchscreen.
2 1 3 4 5 1. Mode Selection 2. Main Pressure and Time Settings 3. Advanced Settings 4. Start Therapy/Pause Therapy 5. Number of Cycles Setting 6.1.1 Timeout Periods The following timeout events may occur on the device: Therapy Pause: Has a timeout period of 5 minutes. If the user pauses the therapy and doesn’t resume it after 5 minutes the device goes into standby mode and displays “therapy complete” message.
Manual mode + and - Phase touch: Has timeout period of 10 seconds, if the user continues to touch + or – button for longer than 10 seconds. The device goes into standby mode. Confirmation Messages: Confirmation messages can only be removed by touch and have no auto timeout. 6.2 Accessing the Main Therapy Screen When you press the Power Switch at the back of the device, the Startup screen appears momentarily with Device logo. The Main Therapy screen then appears, as shown here.
1. Check if the device is in Locked on Unlocked Operation Model. Lock or Unlock the device settings with / menu 2. Check currently selected Therapy Mode and Profile which is highlighted. 3. Change Therapy mode or preset Profile from Therapy mode Menu 4. Check if the main AC power is available with charging symbol on top of battery symbol 5. Check the battery charge status 6. Enable/Disable the Bluetooth 7. Enable/Disable Wi-Fi and select network 8. Change Main therapy pressure and time settings 9.
You can perform the following actions from the Advanced settings screen: • Set oscillation frequency and amplitude • Set vibration on and off • Set inspiratory trigger sensitivity • Set inspiratory flow level • Save current settings as preset profile or remove a preset profile • Access Device settings • Power off the device safely 6.
• Set device display brightness • Select device language • Access Device Administration menu 6.5 Accessing the Device Administration Settings Screen You can access the Device Administration Settings screen from the main therapy screen by following Advanced settings icon > “Device Settings” tab > “Administration” Note: this screen is password protected, please get in touch with your clinician for any changes needed on the device administration settings.
6.6.1 Main Therapy settings From the Main Therapy screen, the following settings may appear on-screen, depending on how the device is configured. Note: When the device is completely locked the users can only select available profiles (presets) enabled by HCP, but not adjust any of the settings.
Pause Time Number of Cycles pressure the patient receives while in the Pause phase of breath. Allows you to set the Pause Time from 0.0 to 30.0 seconds in increments of 1. This setting is not available when the mode is set to Manual or when Inspiratory Trigger is enabled in Auto Mode (see Advanced Settings) Allows you to set number of cycles the device will deliver automatically in Auto Mode. This setting also acts as cycle count down once therapy is started in Auto Mode.
1,2,3 – Increment, decrement, reset the pressure setting 4,5 – Increment, decrement time setting 6 – Confirm the change Note: the pressure and time settings on main screen get auto saved for next reboot if the therapy was delivered with those settings. 6.6.2 Advanced Therapy settings Following therapy settings are available when the user touches the Advanced Settings icon at the bottom left corner of the main screen.
Vibration toggle 6.6.3 If this option is available in the Device Model. Allows you to super impose low amplitude 20 Hz oscillations over and above the set Oscillation frequency and amplitude. Oscillation feature BiWaze Cough device provides oscillation feature during all phases of a breath cycle. The user can enable/disable the oscillations with toggle button on the main screen. The user can also change the Frequency of oscillations in 5-20 Hz Range amplitude in levels 1-5. 6.6.
Once the user is in Advance Cycle Customization mode user can 1. Select any breath cycle by touching the cycle number on the selection band. The selected cycle is highlighted in yellow on the selection bond. 2. Change the settings of selected cycle only. Note: user needs to press before selecting next or different cycle else the changes are not saved. 3. Once a cycle is selected and user has changed the settings of that cycle.
Bluetooth settings • User can enable/disable the Bluetooth • User can initiate the device to be open for pairing mode. Once selected the device stays in pairing mode for 5 minutes and then the pairing mode is switched off automatically. Only paired devices can connect to the device using ABM mobile app.
Following device settings are available for viewing and updating. Setting Language Description Select the language in which the software will appear (English, French, German, etc.) Pressure Units Select the pressure units that display on-screen. You can choose either cmH2O or hPa. All pressure units that appear on-screen display in the unit of measure selected here. LCD Brightness Select the brightness of the screen backlight from 1-10, with 1 being the dimmest setting and 10 being the brightest.
6.7.3 Administrative device settings This screen is intended for use by HCP or clinical staff. User can bring up administrative device settings from device settings menu by selecting “Administration” menu. User will be asked to enter admin password. Following device settings are available for viewing and updating.
Restore Device Settings Insert a USB disk in any of the two available slots in the device and upload the previously downloaded Device Settings. Reset to default 7 Reset the device to default settings. Locking and Unlocking the device The device is recommended to be in the Locked Operation Mode for home users. The information related to access and passwords are available to home care providers. The lock menu is available on top left corner of the screen.
From these options the user can • Select Modes and Profiles available to home user. • Select if user is allowed to adjust pressure and time with in set limits (default 5cm for pressures, 2 secs for breath phase 8 Safe Shutdown and Power off Initiate safe shutdown: Bring up Advanced Settings Panel using icon bottom left corner of the main screen. Touch the power on off button.
Once the screen has shutdown, the led in front turns red. You may now switch off the device with power button at the back of the device. 9 Cleaning and Maintenance 9.1 Cleaning the Device Caution: Remove the main power chord from the device and wall outlet before cleaning the device. The device’s exterior surface should be cleaned before and after each patient use and more often if needed.
§ 10% Chlorine bleach solution Inspect the device and tubing for damage after cleaning. Replace any damaged parts. Allow the device to dry completely before plugging in the power cord. 9.2 Cleaning and Replacing the Air Inlet Filter Under normal usage, you should clean the inlet air filter at least once every 1 month and replace it with a new one every six months. § If the device is operating, stop the airflow. Disconnect the device from the power source. § Remove the filter from the enclosure.
Bacteria Filter: If the device is to be used by more than one patient, the bacterial filter must be replaced to prevent cross contamination. Do not try to wash the bacterial filter. Note: For a single patient replace the circuit after 30 days or 90 therapy cycles whichever comes first. 9.3.2 Home (Individual) Use Patient Circuit: Breathing Hose, Patient Interface and Adapters: After use, the breathing hose and patient interface should be washed thoroughly with liquid dishwashing soap and water.
9.5 Preventive Maintenance This device does not require routine servicing. Only service personnel who are trained and certified by ABM are authorized to service the device. The instructions for service are captured in BiWaze Cough service manual. ABM will make available on request circuit diagrams, component part lists, descriptions, calibration instructions, or other information that will assist to repair those parts of that are designated by as repairable by service personnel.
10.3 Foot Pedal You can use the Foot Pedal (PRTN-2037351818-20120) to deliver therapy in Manual Mode. The Foot Pedal can be connected to the Remote-Control Connector on the side of the BiWaze Cough device. See Section 2.1.4 for port connection details. Note: Therapy has to be started from the main screen before the foot pedal can be used. Caution: Remove the Foot pedal from the device after use and store it safely to avoid entanglement or tripping.
in Manual Model. For more information about availability of mobile app please contact your sales support or health care provider. 10.4.1 Pairing the mobile app to the device Mobile app has to be paired with the device before it can be used. You can turn on the pairing from the Bluetooth menu on the device by enabling the “Pairable ON” toggle on the device. After this step, you can follow the steps in next section for connecting the app to the device.
Please note that the ABM devices will appear with name “ABM Device –“ 2. Once connected the main screen will show status as connected and the current mode from BiWaze.
Manual Mode: User can also initiate Inhale (+ press), Exhale (- Press) and Pause (No touch) phase from the app. See section 4.4.1 for details on Manual Mode Therapy 10.5 Carrying Bag A carrying bag (PRTN-2037351818-1435) is available for BiWaze Cough device. When traveling, the carrying bag is for carry-on luggage only. The carrying bag will not protect the system if it is put through checked baggage.
treatment settings and make breathing comfortable for the user. A number of internal sensor readings are monitored to ensure that the BiWaze Cough functions correctly. Some of them are checked at power up, some at treatment start, and some are monitored continuously. UIB PNEUMATIC MODULE MCB Touch Screen Display Sensor Board Main Control Board (MCB): This board has multiple processors including main processor for control of pressure and flow.
Basic MI-E / Cough Therapy: Single basic Cough cycle comprises of applying a pause pressure followed by an Inspiratory Pressure and suddenly switching to a negative pressure (Expiratory phase). A cough therapy treatment may have multiple um ed i M Hi gh such cycles (usually 5-7 cycles) with pauses in between.
The therapy screen shows the text that trigger is on and allows 30 secs timeout in pause phase to detect patient effort. If patient effort is not detected in that time frame the treatment is paused. Inspiratory Flow: While the expiratory switching is desired to be fast and at high flow to simulate cough, the inspiratory flow may be controlled to a comfortable level by selecting the flow between low, medium and high.
Oscillations Control: BiWaze Cough device allows 5-20 Hz frequency oscillations on applied pressure to facilitate secretions mobilization. Once enabled the oscillation amplitude can be set at 1-5 levels with 1 as the lowest amplitude. Oscillations Oscillations amplitude Note: The mean pressure may vary by up to 25% when the oscillations are on depending on the frequency and set pressure.
12.2 Environmental Operating Temperature Relative Humidity 5° C to 35° C 15 to 95% (non-condensing) Atmospheric Pressure 101 kPa to 77 kPa (approximately 0-2286 meters) Storage -20° C to 60° C 15 to 95% (noncondensing) N/A 12.3 Physical Dimensions 27.5 cm L x 23.5 cm W x 9.0 cm H (10.5” L x 9.2” W x 3.5” H) Weight 3.8 kg (8.4 lbs.) (without battery) 4.1 kg (9.4 lbs.) (with battery installed) 12.
• ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing (Biocompatibility) • ISO 13485: 2016: Medical Devices Quality Management Systems • ISO 14971:2012 : Application of Risk Management for Medical Devices 12.5 Device classifications AC Voltage Source 100 to 240VAC, 50/60 Hz AC Power Supply Input: 100-240 V, 50/60 Hz 1.02.
Transmit Power GFSK: 11.7 dBm (Typ) Receive Sensitivity GFSK: -92.2 dBm (Typ) Modulation Frequency Shift Keying Frequency hopping spectrum Wi-Fi Specification WLAN IEEE Std 802.11b, 802.11g, and 802.11n with 20 MHz and 40 MHz SISO Frequency 2412 MHz to 2462 MHz 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.
Accuracies stated in this manual are based on specific environmental conditions. For stated accuracy, the environmental conditions are: Temperature: 20-30° C; Humidity: 50% relative; Altitude: nominally 380 meters. 12.8 Control Accuracy Parameter Pressure Inhale Time Exhale Time Pause Time Frequency Amplitude Range Accuracy -70 to 70 cmH2O 0-5 seconds 0-5 seconds 0-5 seconds 1-20 Hz ± 5 cmH2O ± (10% of setting + 0.1 second) ± (10% of setting + 0.1 second) ± (10% of setting + 0.
• Inhale Pressure not to exceed 85 cmH2O for 1 minute • Exhale Pressure not to exceed -75 cmH2O for 5 secs • Duration of inhale phase in Auto Mode within ± (10% of the setting + 0.5 seconds) • Duration of exhale phase in Auto Mode within ± (10% of the setting + 0.
13 EMC Information WARNING: • Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the BiWaze Cough System, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.” • The BiWaze Cough System should not be used adjacent to or stacked with other equipment.
function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emissions CISPR 11 Class B Harmonic emissions IEC 61000- Class A 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. 3-2 Voltage fluctuations/Flicker Complies emissions IEC 61000-3-3 13.
Voltage dips, short 0% UT for 0.5 cycle 0 0 0 interruptions and at: 0 , 45 , 90 voltage variations on 1350, 1800, 2250 power supply input lines IEC 61000-4-11 0 0 0 0 at: 0 , 45 , 90 Mains power quality should be that of a typical home or hospital environment. If the user of the device requires continued operation during power mains interruptions, it is recommended that the device be powered from an uninterruptible power supply or a battery. 0 1350, 1800, 2250 270 and 315 . 2700 and 3150.
Radiated RF IEC 61000-4-3 6Vrms in ISM bands between 150KHZ to 80MHz 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 2.7 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).
The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of this device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and this device as recommended below, according to the maximum output power of the communications equipment.
Front, back, left, right Front, back, left, right Front, back, left, right Front, back, left, right Front, back, left, right Front, back, left, right Front, back, left, right Front, back, left, right Front, back, left, right Front, back, left, right Front, back, left, right Front, back, left, right Front, back, left, right 13.
14 Trouble Shooting In case the BiWaze Cough device user runs into any device related issues, some of the issues are self-explanatory and relevant messages are displayed on screen to allow user to take necessary action to come out of the error condition. For other issues related to device problems user may require servicing the device from ABM authorized service center. Please get in touch with your health care provider for such service needs.
Move the device away from any sources of heat or hot ambient temperatures. Switch off the device and restart after 15 minutes of cool down. If problem persists, call your health care provider for servicing the device to replace the filters and functional check. Device does not power up Battery may be too low. Connect the device to mains power and check if the device powers up. If problem persists, call your health care provider for service.
LCD screen in an Orange action based on strip. informational message if needed. Device not performing as Device performance Ensure that you move away intended. Making abnormal malfunction. from any high sounds or therapy electromagnetic or RF performance. radiation sources like MR machines, power transformers etc. If problem persists do not use the device and call your healthcare provider for the service.
Accessories and replacement parts, including, but not limited to, circuits, tubing, leak devices, exhaust valves, filters and fuses, are not covered under this warranty. This warranty is given in lieu of all other express warranties. In addition, any implied warranties – including any warranty of merchantability or fitness for the particular purpose – are limited to one year. Some states do not allow limitations on how long an implied warranty lasts, so the above limitation may not apply to you.
There is no requirement for planned maintenance of this device. 16.3 Service Cleaning and Maintenance There is no field service applicable for the device. Any returns to the manufacturing shall be cleaned and maintained as per manufacturing site work instructions.
BiWaze Cough - User Reference Manual 72
ABMRC, LLC 239 Fairchild St. Charleston, SC 29492 USA Porta Medical UG.
