ABM BiWaze Cough User's Reference Manual

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PRTN-2037351818-1888 1.0

BiWaze Cough

User Reference Manual

UI Software version 1.x

BiWaze Cough - User Reference Manual

Table of Contents

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Do you have a question about the BiWaze Cough and is the answer not in the manual?

Questions and answers

Rich Miller

January 25, 2025

What is the protocol for breath stacking?

1 comments:

Mr. Anderson

May 14, 2025

The breath stacking protocol for the ABM BiWaze Cough device involves using inspiratory triggers and flow settings to assist the patient in achieving maximal lung insufflation. The device detects patient effort through pressure and flow changes during the pause phase. If inspiratory trigger is enabled, the device waits up to 30 seconds to detect an inspiratory effort before delivering the set inspiratory pressure. The inspiratory flow can be adjusted for comfort, while expiratory switching is fast and at high flow to simulate a cough. This approach supports breath stacking by allowing multiple assisted breaths before an exhalation.

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Summary of Contents for ABM BiWaze Cough

Page 1 PRTN-2037351818-1888 1.0 BiWaze Cough User Reference Manual UI Software version 1.x BiWaze Cough - User Reference Manual...
Page 2 BiWaze Cough - User Reference Manual...
Page 3 <11012018> Note: ABM recommends that home care providers set the device back to Lock Mode before returning it to the patient so patients cannot change their prescription settings.
Page 4: Table Of Contents
Back Panel Interfaces ....................13 2.1.4 Side Panel Overview ....................13 2.1.5 Bottom Panel Features ....................14 Symbols ..............................15 Traveling with the System ......................16 How to Contact ABM Respiratory Care ................17 Therapy Modes and Features ................. 17 Therapy Modes ..........................17 Therapy Features ..........................18 3.2.1 Inspiratory Trigger ......................18 3.2.2 Oscillations .
Page 5 Network settings ......................38 6.7.2 Device settings ........................ 39 6.7.3 Administrative device settings ................41 Locking and Unlocking the device ................ 42 Locking options ..........................42 Safe Shutdown and Power off ................43 Cleaning and Maintenance ..................44 BiWaze Cough - User Reference Manual...
Page 6 Technical Specifications .................... 51 12.1 Theory of operations ........................51 12.2 Environmental ............................ 56 12.3 Physical ..............................56 12.4 Standards Compliance ......................... 56 12.5 Device classifications ........................57 12.6 Wireless communication ......................57 12.7 Displayed Parameter Accuracy ....................58 12.8 Control Accuracy ..........................59 BiWaze Cough - User Reference Manual...
Page 7 Federal Communications Commission (FCC) Radiation Exposure ..... 66 Statement .................................. 66 Trouble Shooting ......................67 Limited Warranty ......................69 Service Instructions ....................70 16.1 FRU and Spare parts ........................70 16.2 Planned Maintenance ........................70 16.3 Service Cleaning and Maintenance ..................71 BiWaze Cough - User Reference Manual...
Page 8: Introduction
Use the BiWaze Cough device only as directed by a physician or healthcare provider. • Use the BiWaze Cough device only for the intended use as described in this manual. Advice contained in this manual does not supersede instructions given by the prescribing physician.
Page 9: Contraindications
• 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.
Page 10 No modification of this equipment is allowed by any unauthorized personnel. • Only ABM supplied accessories and consumables like Power Cord, Breathing Circuits, Foot Switch, etc. should be used for optimum performance of the device. • Keep the young children away from the power cable, patient breathing tubes and connectors to prevent any choking or strangulation.
Page 11: Biwaze Product Overview
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.
Page 12: Expected Service Life
The Touch screen allows you to view settings, system status Touch Screen information, real-time patient data, and logs. You can also modify settings from the touch screen. Patient Port Patient circuit tubing is connected to this port on the device BiWaze Cough - User Reference Manual...
Page 13: Back Panel Interfaces
Cuts off AC mains and Batter power to main processor. off switch AC Power Inlet Connect the AC power cord here. 2.1.4 Side Panel Overview The items numbered in the illustration below are described in the table that follows. BiWaze Cough - User Reference Manual...
Page 14: Bottom Panel Features
This is the inlet port for inspiratory air Air Inlet Filter CAUTION: Don’t not attach any unapproved devices or storage medium to any of the ports. Use only ABM approved and supplied parts. Failure to do may damage the system. 2.1.5 Bottom Panel Features The items numbered in the illustration below are described in the table that follows.
Page 15: Symbols
Marking of electrical and electronic equipment in accordance with article 11(2) of Directive 2002/96/EC (WEEE). Should not be disposed in landfill. Environment requirements for storage and shipping Refer to instruction manual BiWaze Cough - User Reference Manual...
Page 16: Traveling With The System
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. BiWaze Cough - User Reference Manual...
Page 17: How To Contact Abm Respiratory Care
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.
Page 18: Therapy Features
When the inspiratory trigger setting is activated in Auto mode, therapy starts in the Pause phase until patient effort is detected or the Pause phase times out after 30 seconds and device goes in standby mode. BiWaze Cough - User Reference Manual...
Page 19: Oscillations
Make sure that the air inlet areas on the left and right of the device are not blocked. Air must flow freely around the device for the system to work properly. 4.2 Assemble the Patient circuit BiWaze Cough System offers two patient circuit types. BiWaze Cough - User Reference Manual...
Page 20: Standard Patient Circuit Kit
Step 2. Ensure that standard 22mm single port adaptor is attached to the device. Attach one if needed. Step 3. Take a standard bacterial filter and attach it to the device. BiWaze Cough - User Reference Manual...
Page 21: Biwaze Custom Patient Circuit
Use appropriate adaptors between tube and patient interface if needed. 4.2.2 BiWaze Custom Patient Circuit BiWaze Cough device comes with an optional “BiWaze custom patient circuit kit” with dual channel for superior hygiene. This kit comprises of: BiWaze Cough - User Reference Manual...
Page 22 Step 4. Attach the BiWaze coaxial 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. BiWaze Cough - User Reference Manual...
Page 23: Supply Power To The Device
1. Plug the socket end of the power cord into the AC inlet on the back of the device. 2. Plug the pronged end into an electrical outlet connected to a wall switch. 3. Ensure that all connections are secure. BiWaze Cough - User Reference Manual...
Page 24: Internal Battery
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.
Page 25: Setup Therapy Modes
9. Go through as many cough cycles as determined by the clinician, until the patient is comfortable. BiWaze Cough - User Reference Manual...
Page 26: Auto Therapy Mode
Profile settings under each Mode. Profiles allow the user to quickly select a group of prescribed settings to apply therapy. See Section 6.3 - Advanced settings for more information on how to save the Profile settings. 4.4.4 Selecting a profile BiWaze Cough - User Reference Manual...
Page 27: Starting And Stopping The Therapy
• User can pause the therapy by touching the “Pause Therapy” Button on main screen while therapy is ongoing. • User can terminate or resume the therapy from the Pause Therapy screen. BiWaze Cough - User Reference Manual...
Page 28: Viewing And Changing Settings
Note: If user does not resume or terminate the therapy from Paused state, the system automatically terminates the therapy after timeout. Viewing and Changing Settings 6.1 Navigating the Menu Screens Navigation for all the menu screens is through main touchscreen. BiWaze Cough - User Reference Manual...
Page 29: Timeout Periods
“therapy complete” message. Manual Mode Pause Phase touch : Has timeout of 5 minutes if the user leaves the device untouched without shifting to positive or negative breath phase. The device goes into standby mode. BiWaze Cough - User Reference Manual...
Page 30: Accessing The Main Therapy Screen
Patient ID field, main settings and measurements. You can perform the following actions from the Main Therapy screen when the device is in standby mode: BiWaze Cough - User Reference Manual...
Page 31: Accessing The Advanced Settings Screen
11. Start/Pause the therapy 6.3 Accessing the Advanced Settings Screen The Advanced Settings screen appears after you touch the settings icon bottom left corner of main screen when the device is in standby mode. BiWaze Cough - User Reference Manual...
Page 32: Accessing The Device Settings Screen
You can perform the following actions from the Device settings screen: • Check the serial number of the device • Check firmware and software versions of the device • Change Date time/ time zones • Check device logs BiWaze Cough - User Reference Manual...
Page 33: Accessing The Device Administration Settings Screen
Download device logs to a USB disk. • Download device settings to a USB disk • Upload/program a device with settings from a USB disk • Configure Remote server for remote logging 6.6 Modifying Patient Therapy Settings BiWaze Cough - User Reference Manual...
Page 34: Main Therapy Settings
Auto mode. This setting is not available when the mode is set to Manual. Pause Pressure Allows you to set the Pause Pressure from 0 to 30 cmH2O in increments of 1. Exhale pressure is the BiWaze Cough - User Reference Manual...
Page 35 Auto Mode. In Manual Mode this field displays count of breath cycles completed. You can select any of the three pressure setting by touching corresponding setting. On touch you will be presented with following window BiWaze Cough - User Reference Manual...
Page 36: Advanced Therapy Settings
Allows user to set the oscillation amplitude in range from Amplitude 1 to 5 with 5 being higher amplitude. Refer to Section: Oscillation Feature for details Oscillation Allows user to select frequency of oscillation in range of Frequency 5-20Hz with increments of 1 BiWaze Cough - User Reference Manual...
Page 37: Oscillation Feature
Oscillation frequency and amplitude. 6.6.3 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.
Page 38: Viewing And Changing Device Settings
6.7 Viewing and Changing Device Settings 6.7.1 Network settings User can perform blue tooth and Wi-Fi configuration from the main screen using the available icon on the top ribbon. BiWaze Cough - User Reference Manual...
Page 39: Device Settings
• Do not connect the device to unknown or public networks 6.7.2 Device settings User can bring up standard device settings from Advanced Settings menu followed by selection of Device Settings button. BiWaze Cough - User Reference Manual...
Page 40 Time Zone Select the time zone for the date/Time HMR reading This displays the total time the patient receives therapy. Therapy logs User can browse therapy logs in the log view panel on this screen. BiWaze Cough - User Reference Manual...
Page 41: Administrative Device Settings
Insert a USB disk in any of the two available slots logs in the device and download the therapy Logs. Backup device Insert a USB disk in any of the two available slots Settings in the device and download the Device Settings. BiWaze Cough - User Reference Manual...
Page 42: Locking And Unlocking The Device
7.1 Locking options BiWaze Cough device menus can be locked with limited flexibility to the home user. After the administrative password is entered the user is presented with following options before the lock operation is complete.
Page 43: Safe Shutdown And Power Off
5cm for pressures, 2 secs for breath phase Safe Shutdown and Power off Initiate safe shutdown: Bring up Advanced Settings Panel using icon at the bottom left corner of the main screen. Touch the power on off button. BiWaze Cough - User Reference Manual...
Page 44: Cleaning And Maintenance
Unplug the device and clean the front panel and exterior of the enclosure as needed using one of the following cleaning agents: A clean cloth dampened with water and a mild detergent § 70% Isopropyl alcohol § DisCide Towelettes § BiWaze Cough - User Reference Manual...
Page 45: Cleaning And Replacing The Air Inlet Filter
§ remove all detergent residue. Allow the filter to air dry completely before reinstalling it. If the filter is § torn or damaged, replace it. Only ABM-supplied filters should be used as replacement filters. Reinstall the filter. § 9.3 Cleaning the Patient Circuit WARNING: Do not sterilize the patient circuit.
Page 46: Home (Individual) Use
While transporting use the carry bag provided with the device. While travelling in airplane do not check in the device, carry it in cabin. Do not place other baggage on top of the device. BiWaze Cough - User Reference Manual...
Page 47: 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.
Page 48: Foot Pedal
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.
Page 49: Pairing The Mobile App To The Device
10.4.2 Connecting the mobile app to the device 1. Ensure that Bluetooth is enabled on both the BiWaze Cough device and the mobile device. Connect to the app to the BiWaze Cough device. BiWaze Cough - User Reference Manual...
Page 50 Please note that the ABM devices will appear with name “ABM Device –“ <last 4 digits of serial number> 2. Once connected the main screen will show status as connected and the current mode from BiWaze. Auto Mode : User can start, pause and resume the therapy from Mobile App...
Page 51: Carrying Bag
12 Technical Specifications 12.1 Theory of operations BiWaze Cough is designed around a pneumatic assembly which controls positive as well as negative pressure and flow delivery to the patient. The main processor monitors sensors for pressure, flow and so on, and controls the blowers to meet...
Page 52 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.
Page 53 Both Inspiratory flow and pressure are monitored during the pause phase (every 16ms) when Inspiratory trigger is enabled. The total patient effort detected is compared with predetermined thresholds. A trigger is raised whenever the effort detected exceeds these thresholds. BiWaze Cough - User Reference Manual...
Page 54 At Low setting, the flow during Inspiratory phase is controlled in such a way that the peak volumetric flow observed during Inspiratory phase is within 40% to 10% of that observed when High setting is applied. BiWaze Cough - User Reference Manual...
Page 55 Note: The mean pressure may vary by up to 25% when the oscillations are on depending on the frequency and set pressure. Vibrations Control : If enabled BiWaze cough device can apply a constant 20 Hz, level 1 amplitude oscillation superimposed on the set oscillation.
Page 56: Environmental
Electromagnetic compatibility – Requirements and tests • EC 60601-1-11: General requirements for basic safety and essential performance – Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment BiWaze Cough - User Reference Manual...
Page 57: Device Classifications
Exposure Protection, IP21 Mode of Operation: Intermittent (30 mins ON – 15 mins OFF) 12.6 Wireless communication Feature Dimension Bluetooth Specification Bluetooth 4.2 Secure Connection Compliant and Bluetooth Compliance CSA2 Support Frequency 2.4 to 2.48 GHz BiWaze Cough - User Reference Manual...
Page 58: Displayed Parameter Accuracy
Peak Cough Flow (PCF) > of ± 15 lpm or 15% 1 lpm 0-500 Exhaled Tidal Volume 1 ml 50-2000 ± (25 +0.15 of reading) for peak (Vte) flows greater than or equal to 20 BiWaze Cough - User Reference Manual...
Page 59: Control Accuracy
The use of these collection, reuse and recycling systems is designed to reduce pressure on natural resources and prevent hazardous substances from damaging the environment 12.11 Essential Performance Note : The Essential Performance of the BiWaze Cough Device is defined as follows: BiWaze Cough - User Reference Manual...
Page 60 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 + 0.5 seconds) • All breath phases with times > 0 occurring in proper order in Auto Mode BiWaze Cough - User Reference Manual...
Page 61: Emc Information
• The BiWaze Cough System should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the BiWaze Cough System should be observed to verify normal operation. If operation is not normal, the BiWaze Cough System or the other equipment should be moved.
Page 62: Guidance And Manufacturer's Declaration - Electromagnetic Immunity
IEC 61000-4-4 Surge ±1 kV line(s) to line(s) ±1 kV line(s) to line(s) Mains power quality should be that of a typical home or IEC 61000-4-5 hospital environment. Not Applicable ±2 kV line(s) to line(s) BiWaze Cough - User Reference Manual...
Page 63: Guidance And Manufacturer's Declaration - Electromagnetic Immunity
Portable and mobile RF communications equipment 3 Vrms Conducted RF IEC 61000- should be used no closer to any 150 kHz to 80 MHz 3 Vrms part of the device, including cables, than the recommended BiWaze Cough - User Reference Manual...
Page 64: Recommended Separation Distances Between Portable And Mobile Rf Communications Equipment And This Device
Over the frequency range 150 kHz to 80 MHz, the field strengths should be less than 3 V/m. 13.4 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and This Device BiWaze Cough - User Reference Manual...
Page 65: Guidance And Manufacturer's Declaration - Electromagnetic Immunity To Wireless Communications Equipment
The customer or user of the device should make sure is used in such an environment. Sides Tested Frequency Test Severity Level Test (MHz) Distance Front, back, left, right 27V/m, 50%PM 18Hz Front, back, left, right 28V/m, FM+5kHz, 1kHz BiWaze Cough - User Reference Manual...
Page 66: Federal Communications Commission (Fcc) Radiation Exposure
(2) this device must accept any interference received, including interference that may cause undesired operation. To maintain compliance, the device must be used with specified BiWaze Cough accessories supplied or designated for this product. Use of other accessories may not ensure compliance with FCC RF exposure guidelines.
Page 67: Trouble Shooting
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.
Page 68 . service. User cannot start the therapy. Information with a self- Informational messages User can acknowledge and explanatory message on the continue with therapy. Take BiWaze Cough - User Reference Manual...
Page 69: Limited Warranty
(1) year from the date of sale by ABM to the dealer. If the product fails to perform in accordance with the product specifications, ABM, will repair or replace – at its option – the defective material or part.
Page 70: Service Instructions
To exercise your rights under this warranty, contact your local authorized ABM dealer or your health care provider or contact ABM at: info@abmrespiratorycare.com...
Page 71: Service Cleaning And Maintenance
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...
Page 72 BiWaze Cough - User Reference Manual...
Page 73 ABMRC, LLC Porta Medical UG. 239 Fairchild St. Holstenstrasse 64a PRTN-2037351818-1395 Charleston, SC 29492 23701 Eutin Germany Model : BiWaze Cough FCC ID : 2ATX9-1395 BiWaze Cough - User Reference Manual...