ABM BiWaze Cough Assembly instructions

BiWaze Cough - User Reference Manual
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BiWaze Cough
User Reference Manual
UI Software version 1.x
PRTN-2037351818-1888 1.0

BiWaze Cough - User Reference Manual
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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. The users can have full access to adjust therapy settings based on the
patient’s physiological needs.
Lock Mode
: In this mode, majority of the therapy settings are restricted/locked. Users cannot
change the therapy air parameters beyond a preset range. However, users can choose
different therapy settings using pre-saved profiles. 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.
When the device is in Lock Mode, use the following steps to enter Unlock Mode:
From the Standby screen, select the lock symbol from left corner of top menu
bar and enter the following password <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.

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Table of Contents
1
!
Introduction
!.....................................................................................................................!8!
1.1!Intended Use!.........................................................................................................................................!8!
1.2!Contraindications!................................................................................................................................!9!
1.3!General Warnings and Cautions!................................................................................................!9!
2
!
BiWaze Product Overview
!.......................................................................................!11!
2.1!System Overview!..............................................................................................................................!11!
2.1.1!Expected service life!....................................................................................................!12!
2.1.2!Main Control Interfaces!..............................................................................................!12!
2.1.3!Back Panel Interfaces!...................................................................................................!13!
2.1.4!Side Panel Overview!....................................................................................................!13!
2.1.5!Bottom Panel Features!...............................................................................................!14!
2.2!Symbols!.................................................................................................................................................!15!
2.3!Traveling with the System!...........................................................................................................!16!
2.4!How to Contact ABM Respiratory Care!..............................................................................!17!
3
!
Therapy Modes and Features
!.................................................................................!17!
3.1!Therapy Modes!.................................................................................................................................!17!
3.2!Therapy Features!.............................................................................................................................!18!
3.2.1!Inspiratory Trigger!.........................................................................................................!18!
3.2.2!Oscillations!........................................................................................................................!19!
4
!
Therapy Setup
!.............................................................................................................!19!
4.1!Position the Device Properly!.....................................................................................................!19!
4.2!Assemble the Patient circuit!......................................................................................................!19!
4.2.1!Standard Patient Circuit kit!.......................................................................................!20!
4.2.2!BiWaze Custom Patient Circuit!...............................................................................!21!
4.3!Supply Power to the Device!......................................................................................................!23!

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4.3.1!Using AC Power!..............................................................................................................!23!
4.3.2!Internal Battery!................................................................................................................!24!
4.3.3!Device Power Source Indicators!............................................................................!24!
4.4!Setup Therapy Modes!...................................................................................................................!25!
4.4.1!Manual Therapy Mode!................................................................................................!25!
4.4.2!Auto Therapy Mode!.....................................................................................................!26!
4.4.3!Preset Profiles Settings!...............................................................................................!26!
4.4.4!Selecting a profile!..........................................................................................................!26!
5
!
Starting and stopping the therapy
!........................................................................!27!
6
!
Viewing and Changing Settings
!.............................................................................!28!
6.1!Navigating the Menu Screens!..................................................................................................!28!
6.1.1!Timeout Periods!.............................................................................................................!29!
6.2!Accessing the Main Therapy Screen!....................................................................................!30!
6.3!Accessing the Advanced Settings Screen!.........................................................................!31!
6.4!Accessing the Device Settings Screen!................................................................................!32!
6.5!Accessing the Device Administration Settings Screen!..............................................!33!
6.6!Modifying Patient Therapy Settings!.....................................................................................!33!
6.6.1!Main Therapy settings!.................................................................................................!34!
6.6.2!Advanced Therapy settings!......................................................................................!36!
6.6.3!Oscillation feature!.........................................................................................................!37!
6.6.4!Auto Mode – Advanced Cough Cycle Customization!...............................!37!
6.7!Viewing and Changing Device Settings!.............................................................................!38!
6.7.1!Network settings!............................................................................................................!38!
6.7.2!Device settings!................................................................................................................!39!
6.7.3!Administrative device settings!................................................................................!41!
7
!
Locking and Unlocking the device
!........................................................................!42!
7.1!Locking options!.................................................................................................................................!42!
8
!
Safe Shutdown and Power off
!................................................................................!43!
9
!
Cleaning and Maintenance
!......................................................................................!44!

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9.1!Cleaning the Device!.......................................................................................................................!44!
9.2!Cleaning and Replacing the Air Inlet Filter!.......................................................................!45!
9.3!Cleaning the Patient Circuit!.......................................................................................................!45!
9.3.1!Institutional (Hospital) Use!........................................................................................!45!
9.3.2!Home (Individual) Use!.................................................................................................!46!
9.4!Storage and transportation.!......................................................................................................!46!
9.5!Preventive Maintenance!..............................................................................................................!47!
10
!
Accessories
!...................................................................................................................!47!
10.1!Patient Circuits!...................................................................................................................................!47!
10.2!USB Disk!................................................................................................................................................!47!
10.3!Foot Pedal!............................................................................................................................................!48!
10.4!BiWaze Mobile App!.......................................................................................................................!48!
10.4.1!Pairing the mobile app to the device!.................................................................!49!
10.4.2!Connecting the mobile app to the device!.......................................................!49!
10.5!Carrying Bag!.......................................................................................................................................!51!
11
!
Informational Messages
!............................................................................................!51!
11.1!Informational Messages!...............................................................................................................!51!
12
!
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!

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12.9!Sound!......................................................................................................................................................!59!
12.10!Disposal!.................................................................................................................................................!59!
12.11!Essential Performance!...................................................................................................................!59!
13
!
EMC Information
!.........................................................................................................!61!
13.1!Guidance and Manufacturer’s Declaration - Electromagnetic Emissions!.......!61!
13.2!Guidance and Manufacturer’s Declaration - Electromagnetic Immunity!........!62!
13.3!Guidance and Manufacturer’s Declaration - Electromagnetic Immunity!........!63!
13.4!Recommended Separation Distances between Portable and Mobile RF
Communications Equipment and This Device!...............................................................!64!
13.5!Guidance and Manufacturer's Declaration - Electromagnetic Immunity to
Wireless Communications Equipment!................................................................................!65!
13.6!Federal Communications Commission (FCC) Radiation Exposure!.....................!66!
Statement!..................................................................................................................................................................!66!
14
!
Trouble Shooting
!........................................................................................................!67!
15
!
Limited Warranty
!........................................................................................................!69!
16
!
Service Instructions
!....................................................................................................!70!
16.1!FRU and Spare parts!......................................................................................................................!70!
16.2!Planned Maintenance!....................................................................................................................!70!
16.3!Service Cleaning and Maintenance!.......................................................................................!71!

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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. Finally, the pause phase
provides positive pressure which keeps the airways open in between the inhale and exhale
phases.
This User Guide is applicable for product “BiWaze Cough” (Model “BiWaze Cough”)
indented for a patient or care provider user.
WARNING
• 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.
• Read the entire manual before using the BiWaze Cough device.
• Install and configure the BiWaze Cough device 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.
1.1 Intended Use
This product is used for assisting patients to clear retained bronchopulmonary secretions
by gradually applying positive pressure to the airway, then rapidly shifting to a negative
pressure. This rapid shift in pressure, via a facemask, mouthpiece, endotracheal or
tracheostomy tube produces a high expiratory flow rate from the lungs, simulating a
cough
This device is designed for use on patients unable to cough or clear secretions effectively
due to reduced peak cough expiratory flow, resulting from high spinal cord injuries,

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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
1.3 General Warnings and Cautions
The following are general warnings and cautions. Further specific warnings, cautions and
notes appear next to the relevant instruction in the manual.
WARNING
A
warning
alerts you to possible injury.
• 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.
• If you notice any unexplained changes in the performance of this device, if it is making
unusual or harsh sounds, if the device or the power supply are dropped or
mishandled, if water is spilled into the enclosure, or if the enclosure is broken,
discontinue use and contact your home care provider.
• Device shall not be operated on a patient without a Bacterial/Viral (B/V) filter along
the Breathing Circuit.
• Always use a new bacterial filter when using the device on a new patient.
• Always check time and pressure settings before each treatment.
• Soreness and/or pain in the chest from a pulled muscle may occur in patients using
the BiWaze Cough for the first time if the positive pressure used exceeds pressures
which the patient normally receives during Positive Pressure Therapy. Such patients

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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. The device should be serviced by authorized personnel only.
• Do not modify this equipment. 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.
• If connected, disconnect the Foot Pedal remote after use from the device to avoid
tripping.
CAUTION
A
caution
explains special measures for the safe and effective use of the device.
• Do not expose the device to excessive force, dropping or shaking.
• Keep the power cord and device away from any potential heat sources like room
heater, hot iron, kettle steam etc.
• Shut down the device when not in use
• Make sure that all the air inlets at the side of the device are unobstructed. If the
device is put 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.
• Do not operate the device while it’s in its carrying case.
• Do not operate the device in direct sunlight for better visibility and avoid heating the
LCD screen.
• Hair from Pets, Spillage of food and infestation by pests can cause the device to have
clogged filters. Keep the Device away from young children, pets and ensure that
operating and storage environment is free from any pests.
• Do not operate the device in very dusty environment outside the room or in an
environ with small fibers or airborne material which can clog the filters.
• Main Device has Ingress protection rating of IP21, it can withstand minor vertical spills
and wiping for cleaning. Do not splash/spray water or submerge the device in water.
• Disconnect the foot pedal and store it safely after user to avoid tripping on it.