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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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.
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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.
• Carrying Case
• AC Power Cord
• User Reference Manual
Accessories
• Foot Pedal
• Various Patient Interface Accessories (Mask sizes, trach adapters, mouthpiece
interface)
• BiWaze Coaxial Patient Circuit Tubing
2.1
System Overview
The BiWaze Cough helps patients in clearing excessively retained
bronchopulmonary secretions in the lungs and upper airways. This is done by
progressively applying positive pressure to the airway and then rapidly shifting to a
significant negative pressure. This action replicates the effects of a natural cough and
thereby helping in removal of secretions retained in the airways.
The therapy air is delivered through a Breathing Circuit which generally consists of
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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
power cords
5 Years
Patient Breathing tubes
30 days after unpacking
Carry Bag
2 years
Batteries
1 year
2.1.2 Main Control Interfaces
The items numbered in the illustration below are described in the table that follows.
1
Touch Screen
The Touch screen allows you to view settings, system status
information, real-time patient data, and logs. You can also
modify settings from the touch screen.
2
Patient Port
Patient circuit tubing is connected to this port on the
device
1
2
3
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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.
Item
Description
1
Handle
Handle to carry the device
2
Power source cut
off switch
Cuts off AC mains and Batter power to main processor.
3
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.
23
1
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Item
Description
1
Foot Pedal port
Connection port for Foot Pedal
2
HDMI port
External HDMI display can be connected here
3
USB ports
USB memory sticks and SPo2 connectors are connected
here
4
Air outlet
This is the outlet port for expiratory air
5
Power supply cooling
Fan location
Cooling fan is located here
6
MCB Fan
Fan with main control board
7
Air Inlet Filter
This is the inlet port for inspiratory air
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.
1
Device Left Side
Device Right Side
1 2 3
4 5
6 7
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Item
Description
1
Battery housing
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., a finger) and
protected against vertically falling drops of water or condensation
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
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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.
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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.
3
Therapy Modes and Features
3.1
Therapy Modes
Therapy Mode
Description
Manual
Manual mode delivers therapy based on the Pause
Pressure Inhale Pressure and Exhale Pressure prescription
settings. The device delivers the set InhalePressure for
the amount of time that the “+” button is pressed.The
device delivers the set ExhalePressure for the amount of
time that the “-“ is pressed and delivers Pause Pressure
when neither button are pressed Therapy starts in the
Pause Phase when activated in Manual mode.
Auto
Auto mode delivers therapy based on the following
prescription settings: Inhale Pressure, Inhale Time, Exhale
Pressure, Exhale Time, Pause Pressure,Pause Time and
Number of Cycles. Auto mode delivers pressure in the
following sequence, repeating the sequence until the
user pauses & exits the therapy, or the number of cycles
count is reached:
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1. Positive pressure at the Inhale Pressure setting for the
duration of the Inhale Time setting.
2. Negative pressure at the Exhale Pressure setting for
the duration of the Exhale Time setting.
3. 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. Positive pressure at the Inhale Pressure setting when
the device detects the patient’s effort to inhale for the
duration of the Inhale Time setting.
2. Negative pressure at the Exhale Pressure setting for
the duration of the Exhale Time setting.
3. Pause pressure until the device detects the next
inspiratory Effort or Pause phase timeout of 30 secs.
Note: The device goes in standby mode and therapy is
paused when there is a breath phase time out.
3.2
Therapy Features
The device provides the following therapy features.
3.2.1 Inspiratory Trigger
An important characteristic of the device is its ability to trigger on the patient’s
inspiration to help synchronize the therapy with the patient.
The inspiratory trigger feature is available when the device is in Auto mode. The
pressure delivery sequence is synchronized with the patient’s effort to inhale.
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.
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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.
If the Oscillation setting is enabled, the user can choose to apply the vibrations along
with oscillations. Vibrations are low amplitude 20Hz oscillations which are super
imposed on standard oscillations. The Frequency and Amplitude settings of
oscillations can be changed as needed.
4
Therapy Setup
Follow the following steps to prepare the device for the therapy.
Note
: If the device was stored in temperature below 5 °C or above 35 °C, allow the
device to normalize for 15 minutes at room temperature (~20 °C) before using the
device.
4.1
Position the Device Properly
Position the device on a firm, flat surface within arm’s length reach of the patient or
device operator. The device should be placed below elbow level for best visibility of
the screen. 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.
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4.2.1 Standard Patient Circuit kit
Standard Patient Circuit kit comprise of:
a. Standard patient circuit adaptor for
“Standard Tube to Device”
connection
b. Standard bacterial filter
c. Optional 22mm “tube to patient
interface” connector.
d. Standard 6 feet long, 22 mm
diameter single tube
Setting Standard Patient circuit for Therapy
Step 1.
Identify the Patient circuit Kit: If the patient circuit tube is a single tube
without any tube inside the outer tube, its standard patient circuit tube.
Step 2.
Ensure that standard 22mm single port adaptor is attached to the device.
Attach one if needed.
P
Step 3.
Take a standard bacterial filter and attach it to the device.
abc
d
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