Breas Clearway 2 User manual

User Manual
009077 V
6
Revised: MAR 202
2

Introduction 2
DOC-001000 Ver 6Clearway 2 User Manual .
Table of Contents
1Introduction ............................................................................................................. 4
Icons................................................................................................................ 5
What is the Clearway 2? .................................................................................. 6
Intended Use ................................................................................................... 6
Warnings & Cautions ....................................................................................... 9
Contraindications to Use................................................................................ 11
Considerations before Use............................................................................. 12
Undesirable Side Effects................................................................................ 12
About this Manual .......................................................................................... 13
Manufacturer Contact Information.................................................................. 13
2Safety Information ................................................................................................. 14
General User Precautions.............................................................................. 14
Electrical Safety ............................................................................................. 15
Environmental Safety..................................................................................... 16
The Usage of Oxygen if Prescribed ............................................................... 18
Commonly Used Abbreviations and Terms .................................................... 19
3Product Description .............................................................................................. 20
Main Components.......................................................................................... 20
Front Panel .................................................................................................... 21
Side Panels ................................................................................................... 22
Back Panel .................................................................................................... 22
Equipment Designation and Safety Labels..................................................... 23
4Preparing the Clearway 2 for Use......................................................................... 25
Checking the Device before Use.................................................................... 25
Placing the Clearway 2 Ready for Use........................................................... 25
Connecting to AC Power (Mains Power) ........................................................ 26
Inspecting the Clearway 2 before Use ........................................................... 26
5How to Use the Clearway 2 ................................................................................... 27
Connecting the Patient Circuit........................................................................ 27
Circuits........................................................................................................... 28
Turning the Device On/Off ............................................................................. 29
On-Screen Symbols....................................................................................... 29
General Functionality and Display.................................................................. 30
Main Menu..................................................................................................... 33
Treatment Settings......................................................................................... 37
Profiles........................................................................................................... 38
Saving a Treatment Profile............................................................................. 38
Starting and Stopping Treatment.............................................................. 39
Recruitment Breaths ................................................................................ 40
Preview Treatment ................................................................................... 42
Entraining Oxygen.................................................................................... 43
Use with SpO2Sensor.............................................................................. 43
Accessing User Data................................................................................ 45
Using Batteries......................................................................................... 45
Transferring data...................................................................................... 48

3Introduction
Clearway 2 User Manual DOC-001000 Ver 6
6Alarms.................................................................................................................... 49
Alarm Function............................................................................................... 49
Alarm Indication ............................................................................................. 49
Alarm Reset ................................................................................................... 50
Alarm and Warning descriptions .................................................................... 50
7Cleaning & Maintenance ....................................................................................... 57
Cleaning the Clearway 2................................................................................ 58
Changing the Air Inlet Filter............................................................................ 59
Change of Patient .......................................................................................... 60
Essential and Regular Maintenance Control .................................................. 61
Service and Repair ........................................................................................ 61
Storage .......................................................................................................... 62
Transport ....................................................................................................... 62
Disposal......................................................................................................... 62
8FAQ’s & Troubleshooting ..................................................................................... 63
FAQ’s ............................................................................................................ 63
Troubleshooting ............................................................................................. 65
9Technical Specifications....................................................................................... 66
System Description........................................................................................ 66
Data Parameters............................................................................................ 67
Electrical Information ..................................................................................... 68
Environmental Operating Conditions.............................................................. 69
Dimensions.................................................................................................... 70
Emissions and Immunity Declaration ............................................................. 71
Compliance of Standards............................................................................... 72
Clearway 2 in other countries......................................................................... 77
10 Accessories ........................................................................................................... 78
Package Contents.................................................................................... 78
Optional Accessories ............................................................................... 79
Patient Settings................................................................................................................. 80
Glossary of Terms ............................................................................................................ 81
Index .................................................................................................................................. 82

Introduction 4
DOC-001000 Ver 6Clearway 2 User Manual .
1 Introduction
WARNING!
Clearway 2 must only be used:
•for the intended treatment in accordance with this operating
manual and with the instructions given by the responsible
clinical personnel
•in accordance with the operating conditions specified in this
operating manual
•in original and unmodified shape and only with accessories
specified or approved by Breas Medical Ltd.
Every other use may lead to risk of personal injury!
CAUTION!
Read this operating manual thoroughly so that you completely
understand how the Clearway 2 is operated and maintained before
taking it into use, to ensure correct usage, maximum performance
and serviceability.
Non-professional caregivers (e.g. family members and carers)
should consult the medical equipment provider’s respiratory
therapist if they have any questions about the function, proper use,
operation, service or maintenance of the Clearway 2.
Breas Medical Ltd reserves the right to make changes to this product
without any prior notification.
U.S. Federal law restricts this device to sale by or on order of a
physician.

5Introduction
Clearway 2 User Manual DOC-001000 Ver 6
Icons
Within this manual you will see the following icons. The meaning of each icon
is explained in the table below
Icon
Explanation
Warning!
Risk of death or serious personal injury
Warning!
Risk of electrical shock
Warning!
Risk of cross-contamination
Warning!
Flammable material, risk of fire
Caution!
Risk of equipment damage, loss of data, extra work, or
unexpected results
Note
Information that may be valuable but is not critically
important
Reference
Reference to other manuals with additional information on a
specific topic

Introduction 6
DOC-001000 Ver 6Clearway 2 User Manual .
What is the Clearway 2?
The Clearway 2 is an airway clearance device that provides the following
therapeutic options:
•Mechanical Insufflation-Exsufflation (MI-E)
•Intermittent Positive Pressure Breathing (IPPB)
•Non-Invasive Ventilation (NIV) for therapeutic use
Intended Use
Only use the Clearway 2 as it is intended. Failure to do so may
cause serious harm or injury to the patient.
Never use without the appropriate training and resuscitation
equipment available. Please contact Breas Medical Ltd if
training is required.
The Clearway 2 airway clearance device assists patients in loosening,
mobilizing, and clearing secretions, as well as promoting lung volume
recruitment by Mechanical Insufflation-Exsufflation (MI-E). The device can
be used by adult or paediatric patients that have compromised secretion
clearance and/or a reduced ability to cough effectively.
The device can be used for MI-E in both invasively and non-invasively
ventilated patients as well as patients who are self-ventilating. The device may
be used either with a facemask, mouthpiece, or with a suitable adapter to a
patient’s endotracheal (ET) or tracheostomy tube (MI-E only).
The device is intended for use within a hospital, institutional environment, or
in the home.
The Clearway 2 must only be used under the direction and
prescription of a physician, respiratory therapist, or other
qualified persons.

7Introduction
Clearway 2 User Manual DOC-001000 Ver 6
The Clearway 2 device combines three therapy options;
•Mechanical Insufflation-Exsufflation (MI-E)
•Intermittent Positive Pressure Breathing (IPPB)
•Non-Invasive Ventilation (Therapeutic use only)
IPPB mode and NIV mode must only be used non-invasively.
When used as a mechanical ‘insufflator-exsufflator’ (MI-E), it provides a
positive pressure to the airway, followed rapidly by a negative pressure to
promote the removal of secretions. This is achieved through increasing the
expiratory flow from the lungs, in order to replicate normal cough function.
Optional oscillatory vibrations may assist in loosening and mobilising the
secretions further while the remaining rapid shift to negative pressure results
in achieving a sufficient expiratory flow rate from the central airway, which
enables the clearance of respiratory secretions.
Individuals who may benefit from the use of the Clearway 2 include any patient
with an ineffective cough due to;
•Muscular Dystrophy
•Amyotrophic lateral sclerosis (ALS) or Motor Neurone Disease (MND)
•Myasthenia Gravis
•Poliomyelitis
•Other Neurologic Disorders
•Spinal Cord Injury
The Clearway 2 can be used for Intermittent Positive Pressure Breathing
(IPPB) and therefore may also be used in patients with bronchopulmonary
disease to promote effective secretion removal and or lung volume
recruitment, patient with the following conditions may benefit from using the
Clearway 2 for IPPB;

Introduction 8
DOC-001000 Ver 6Clearway 2 User Manual .
•Cystic Fibrosis
•Bronchiectasis
•Emphysema
•Post-surgical patients (with no contraindications)
The Clearway 2 device can be used for MI-E in both invasively and non-
invasively ventilated patients as well as patients who are self-ventilating. The
Clearway 2 device may be used either with a facemask, mouthpiece, or with a
suitable adapter to a patient’s endotracheal (ET) or tracheostomy tube (MI-E
only).
The Clearway 2 must only be used non-invasively when using the IPPB mode.
Only a facemask or mouthpiece should be used to administer IPPB therapy
with the Clearway 2.
Internal Memory
The Clearway 2 has an internal memory that holds the following data:
•Therapy (running) hours
•Technical and physiological alarms
•Device and treatment settings
•Treatment setting changes
•Device log of events
•Serial numbers
The internal memory data is maintained even during power failure. The data
can be transferred to a computer, printed out, and analysed via Breas software
products.
For more information about Breas software products, please contact your Breas
representative.

9Introduction
Clearway 2 User Manual DOC-001000 Ver 6
Warnings & Cautions
Warnings!
•
This device must only be used under the direction and
prescription of a physician
, respiratory therapist, or other
qualified persons.
•Do not leave a patient unattended during any treatment
•Always check the prescription, time and pressure settings before
each treatment or between patients,
as different modes and
profiles may have different prescription settings
•
Only use the device with access to suction and the correct
emergency resuscitation equipment in place
•Patients known to have cardiac instability should be monitored
for pulse and
oxygen saturation very closely and therapy
terminated if the patient shows sign of deterioration
•Always follow this manual for use, service requirements and with
advised accessories (see page 78)
•Monitor the device while in use and stop providing treatment if
the device malfunctions
•The Clearway 2 must only be serviced by personnel certified by
Breas
•Use only power cords supplied by Breas Medical Ltd
for this
device
•Do not use in the presence of flammable anaesthetics
•Unplug the device if it comes into contact with water
•Do not use the device if it has a damaged cord or p
lug, is not
working properly, has been dropped, or immersed in water. In
this event contact your local service centre
•Ensure all cables for the device and accessories are away from the
patient to avoid risk of accidental strangulation.
•Do not operate device while in carry bag
•Always use a new, low resistance, bacterial filter when using the
device on a new patient

Introduction 10
DOC-001000 Ver 6Clearway 2 User Manual .
Cautions!
•Always place the Clearway 2 on a hard, clean surface, not on the
floor
•Always place foot
pedal on dry surface. Ensure cable does not
cause a trip hazard
•Always position the Clearway 2 so that the air inlets are not
obscured or blocked
•Never use the device unless a bacteria filter is
attached to the
patient circuit
•Keep the power cord in good o
rder and away from heated
surfaces
•Device is not suitable for sterilisation. F
or instructions on
cleaning the Clearway 2 see page 57
•In the event of a power failure or malfunction remove the mask
or patient interface, and ensure airways are clear
This product does not contain latex in any of its components or
accessories

11 Introduction
Clearway 2 User Manual DOC-001000 Ver 6
Contraindications to Use
Before using the Clearway 2, ensure the patient does not have
any of the following conditions.
The patient should be reviewed regularly to ensure that their condition has not
altered. If the user of the Clearway 2 develops one of the below
contraindications, contact your referring Clinician before continuing to use the
Clearway 2:
•Patients with a history or risk of bullous emphysema
•Patients with a history or are susceptible to pneumothorax or pneumo-
mediastinum
•Patients with cardiovascular instability
•Patients with tracheoesophageal fistula
•Recent or existing barotrauma
•Spinal instability
•Acute pulmonary oedema
•Active, untreated tuberculosis
•Active haemoptysis and frank haemoptysis
•Recent oesophageal surgery
•Increased intracranial pressure
•Acute lung injury
•Facial, skull or oral trauma and or surgery
•Fractured ribs with flail segments

Introduction 12
DOC-001000 Ver 6Clearway 2 User Manual .
Contraindications to IPPB Mode
Careful evaluation of the patient will need to be carried out prior to
commencement of IPPB treatment. Contraindications to using IPPB mode
include contraindications in page 11, and the following, but are not limited to:
•Tension pneumothorax
•Uncontrolled asthma
•Surgical emphysema
•Vomiting
•Cardiovascular instability
•Flail chest
Considerations before Use
Do not use the Clearway 2 with patients with the below
conditions without specific instructions from your referring
clinician.
A risk assessment and guidance should be provided. If the patient develops
any of the below symptoms/conditions, you must consult the referring
clinician before continuing use of Clearway 2.
•Bulbar insufficiency
•Nausea or risk of vomiting
•Gastrointestinal feed
•Changes in symptoms or effectiveness of the treatment
Undesirable Side Effects
If undesirable side effects are witnessed or reported, treatment should stop
immediately, and the referring or responsible physician must be notified. If
treatment becomes ineffective at clearing secretions and augmenting a cough,
please contact your referring physician/clinician or home care provider.

13 Introduction
Clearway 2 User Manual DOC-001000 Ver 6
About this Manual
Always read this manual in full before using the device or
performing maintenance on the machine. This is to ensure
correct and safe usage as well as maximum performance and
serviceability.
Intended Audience
This manual is intended for the lay caregiver of a patient requiring medical use
of the Clearway 2 device. The manual comprises information on general use
of the Clearway 2. Patients and lay caregivers may read this manual for
reference purposes, after appropriate guidance from the responsible care
provider.
•Clinical personnel or medical professionals should read the Clinical
Manual for thoroughly to completely understand how the Clearway
2 is operated and maintained before taking it into use, to ensure
correct usage, maximum performance and serviceability.
•Service personnel may order the Clearway 2 Service
Manual that
contains detailed technical information for maintenance, service and
repair.
Manufacturer Contact Information
To Contact Breas Medical Ltd:
Unit A2, Timothy’s Bridge Road Tel: [phone]
Stratford-upon-Avon email: [e-mail]
Warwickshire, United Kingdom
CV37 9HW www.breas.com

Safety Information 14
DOC-001000 Ver 6Clearway 2 User Manual .
2 Safety Information
General User Precautions
Clearway 2 must only be used:
•For the intended treatment in accordance with this operating manual and
with the instructions given by the responsible clinical personnel
•In accordance with the operating conditions specified in this operating
manual
•In the original and unmodified form and only with accessories specified
or approved by Breas Medical Ltd.
•If the patient is using the Clearway device outside the hospital
environment, there should always be a trained caregiver administering
the therapy and to monitor the patient during and after therapy is carried
out.
•When using the Clearway 2, there should always be access to suction and
emergency resuscitation equipment available.
•If the patient is admitted to a hospital or is prescribed any other form of
medical treatment, always inform the medical staff that the patient has
been prescribed a Clearway 2 device for either MI-E or IPPB.
•Do not use the Clearway 2 in the event of suspected damage to the
device, unexplainable or sudden pressure, performance or sound
changes during operation, or if the delivered air from the Clearway 2 is
abnormally hot or emits an odour. In these cases, contact the patient’s
responsible care provider for an inspection or Breas Medical Ltd.
•The Clearway 2 may not work properly if any part has been dropped,
damaged or submerged in water.
•Inadequate use of device or accessories may cause loss of treatment or
decreased performance.
•The Clearway 2 therapy settings must always be based on medical
prescription and must be carried out by authorised clinical personnel
only.

15 Safety Information
Clearway 2 User Manual DOC-001000 Ver 6
•Always perform the procedure “Inspecting the Clearway 2 before Use”
(page 26) before use.
•Ensure all accessories are compatible with the Clearway 2 before use.
•Clinical personnel must read this manual before use.
•Handle the Clearway 2 with care.
•Do not use the Clearway 2 while in the carry bag.
•Do not use the Clearway 2 with nitric oxide, helium or helium mixtures.
•Prolonged exposure of the SpO2sensor can cause contact injuries to
skin
NOTE: Any serious incident that has occurred in relation to this
device should be reported to the competent authority and the
manufacturer.
Electrical Safety
To ensure electrical safety is maintained ensure the following
procedures are met:
•Do not operate the Clearway 2 if it has a damaged power cord or
casing.
•To avoid electrical shock, disconnect the electrical supply to the
Clearway 2 before cleaning. Do not immerse the Clearway 2 into
any fluids.
•If a multiple portable socket-outlet is used, it must not be placed
on the floor.
•Do not use more than one multiple portable socket-
outlet or
extension cord.
•The operator must not touch accessible contacts of connectors
and the patient simultaneously.
•The aspects of electromagnetic compatibility must be considered.
•The Clearway 2 should not be used adjacent to or stacked with
other equipment; if adjacent or stacked use is necessary, the

Safety Information 16
DOC-001000 Ver 6Clearway 2 User Manual .
Clearway 2 should be observed to verify normal operation in that
configuration.
•Mobile or transportable radio transmitters may interfere with the
Clearway 2 or performance of the display. Guidance for safe
positioning of the Clearway 2 available on page 76.
•If a portable AC power supply is used, make sure that the voltage
variations are within the operating limits of the Clearway 2. See
“Electrical Information” on page 68 for AC operating limits.
•
Use of accessories, transducers and cables other than those
specified
or provided by Breas could result in increased
electromagnetic emissions or decreased electromagnetic
immunity of this equipment and result in improper operation.
Environmental Safety
To ensure environmental safety is maintained ensure the below
procedures are met
•Do not use the Clearway 2 in any toxic environment.
•Do not use the Clearway 2
in environments where there are
explosive gases or other flammable anaesthetic agents present.
•The performance of the Clearway 2
may deteriorate at ambient
temperatures below -4°F (-20°
C) and above 104°F (40°C).
However, the treatment shall always be started in an ambient
temperature warmer than 41°F (5°C).
•Do not expose the Clearway 2 to rain or snowfall.
•
Do not use or store in the presence of strong electromagnetic
fields such as an MRI environment. Use of the Clearway 2 in an
MR environment may result in malfunction of the Clearway 2 and
pose unacceptable risk to the patient, medical staff, or other
persons.

17 Safety Information
Clearway 2 User Manual DOC-001000 Ver 6
•Do not use the Clearway 2 positioned in a warm place, such as
direct sunlight or close to a radiator.
•Do not use the Clearway 2 positioned near an open fire.
•
The device complies with the EMC requirements of standards
listed in “Compliance of Standards” on page 72. Necessary
measures should be taken in order to assure field levels exceeding
20 V/m are
avoided, since this may impair the safety and
performance of the Clearway 2.
•Measures should include but not be limited to:
–Normal precautions regarding relativ
e humidity and
conductive characteristics of clothing in order to minimize the
build-up of electrostatic charges.
–Avoiding the use of radio emitting devices closer than 1 m to
the Clearway 2
. Radio emitting devices include cellular or
cordless telephones, microwave ovens and high-frequency
surgery apparatus.
–Avoiding the use of Clearway 2 in the presence of known EMI
sources including RF emitters (e.g. RFID, surgical or
therapeutic diathermy equipment). Please note some of these
RF emitters may not be visi
ble and the Clearway 2 can
potentially be exposed to fields from these RF emitters without
the user’s awareness. If abnormal performance of the Clearway
2 is observed and the RF emitters cannot be identified and
removed, the Clearway 2 may need to be reori
ented or
relocated.
–The Clearway 2, any accessories and all replaced parts must be
disposed
of in accordance with the local environmental
regulations regarding
the disposal of used equipment and
waste.
–The performance of the Clearway 2 and treatment of the
patient may deteriorate if the operational
conditions in
“Technical Specifications” (page 66) are not fulfilled.

Safety Information 18
DOC-001000 Ver 6Clearway 2 User Manual .
The Usage of Oxygen if Prescribed
To ensure the safe use of oxygen, always adhere to these
guidelines.
Only use oxygen as directed and prescribed by
your referring clinician.
•Always follow the oxygen provider’s instructions.
•The presence of oxygen can speed up combustion of inflammable
materials.
•At a fixed rate of supplemental oxygen flow, the inhaled oxygen
concentration will vary, depending on the pressure delivered, the
mode and settings, the patient’s breathing pattern and leak rate.
•When oxygen is used with the Clearway 2, the oxygen flow must
be turned off when the Clearway 2
is not operating. Oxygen
delivered into
the patient tubing may accumulate within the
machine enclosure.
Oxygen accumulated in the machine
enclosure will increase the risk of fire.
•Ventilate the room adequately.
•Do not smoke in a room where oxygen is being used.
•Do not use the Clearway 2 positioned near or in a room with an
open fire.
•Naked light bulbs and other sources of ignition must be kept a
minimum of 6 feet (2 meters) away from the oxygen cylinder or
any part of the patient circuit.
•Do not use aerosols or solvents close to the oxygen supply, even
when the oxygen supply is shut off

19 Safety Information
Clearway 2 User Manual DOC-001000 Ver 6
Commonly Used Abbreviations and Terms
Abbreviation
or Term Clarification
BPM
Breaths Per Minute (Breath Rate)
IPPB
Intermittent Positive Pressure Breathing
NIV
Non-Invasive Ventilation
Doctor
Prescribing Health Care Professional e.g. Physician,
Physiotherapist
Carer
Persons caring for the patient e.g. Nurse or Family/Friend
User
Main user of the device. Usually the carer, or the patient
themselves
Patient
Persons prescribed the device for medical care/treatment
Insufflation
Inhale stage of a cough treatment cycle
Exsufflation
Cough (exhale) stage of a cough treatment cycle
Inspiratory
Inhale stage of a respiratory cycle
Expiratory
Exhale stage of a respiratory cycle
Cycle
A single run of a set number of insufflations, followed by
an Exsufflation (unless used in NIV or IPPB)
Treatment
A treatment is a set number of cycles of the prescribed
settings, at the frequency stated by the prescribing
physician/physiotherapist/doctor

Product Description 20
DOC-001000 Ver 6Clearway 2 User Manual .
3 Product Description
Main Components
The main components of Clearway 2 are detailed below:
No.
Description
Product Code
1 Clearway 2 Device 232000
2 Clearway 2 Carry Bag 008284
3 AC Mains Power Cable 009074
4 User Manual 009077
5 Patient MI-E Circuit 008276
For more accessories please see section 10, Accessories