Breas Clearway 2 User manual

Service Manual
Technical
Instructions for Use
2210.2657 Revision 3
.0

Introduction 2
2210.2657 Rev 3.0 NIPPY Clearway 2 Service Manual .
Table of Contents
1Introduction ............................................................................................................. 4
Manufacturer Contact Information.................................................................... 4
What is the Clearway 2? .................................................................................. 4
Intended Use ................................................................................................... 4
Service Personnel Training Requirements ....................................................... 5
About this Manual ............................................................................................ 5
Icons................................................................................................................ 6
2Maintenance Instructions ....................................................................................... 7
Purpose ........................................................................................................... 7
Introduction...................................................................................................... 7
Service Schedule............................................................................................. 8
Inspection Equipment and Tools ...................................................................... 9
Replacement Parts ........................................................................................ 10
Preparing for Inspection................................................................................. 10
External Inspection ........................................................................................ 11
Function test .................................................................................................. 12
Internal inspection.......................................................................................... 15
Electrical Safety ............................................................................................. 16
3Service Menu ......................................................................................................... 17
Introduction.................................................................................................... 17
Set Time and Date......................................................................................... 17
Calibration ..................................................................................................... 18
Diagnostic Screen.......................................................................................... 23
Alarm Log ...................................................................................................... 23
Install defaults................................................................................................ 23
4Part identification .................................................................................................. 24
Inside Front Case .......................................................................................... 24
Display PCB .................................................................................................. 25
Inside Rear Case ........................................................................................... 26
Power PCB .................................................................................................... 27
5Parts List................................................................................................................ 28
6Functional Diagrams ............................................................................................. 29
Clearway 2 block diagram.............................................................................. 29
Control PCB block diagram............................................................................ 30
Display PCB block diagram............................................................................ 31
Pneumatic diagrams ...................................................................................... 32
7Removing Main Components ............................................................................... 33
Removing and Replacing the Internal Battery ................................................ 33
Opening and Closing the Case ...................................................................... 34
Removing and Replacing the Power Control PCB ......................................... 35
Removing and Replacing the Communications PCB...................................... 35
Removing and Replacing the Display Command PCB ................................... 36
Removing and Replacing the Blower ............................................................. 36
Removing and Replacing the Valve Assembly ............................................... 37
Removing and Replacing the Power Supply .................................................. 38

3Introduction
NIPPY Clearway 2 Service Manual 2210.2657 Rev 3.0
Removing and Replacing the Flow Transducer.............................................. 38
Removing and Replacing the Clock Battery ................................................... 39
Removing and Replacing the Alarm battery ................................................... 40
8Electronics............................................................................................................. 42
Power Control PCB........................................................................................ 42
Display Command PCB ................................................................................. 43
Communication (comms) PCB....................................................................... 43
9Pneumatic System................................................................................................. 44
10 Batteries................................................................................................................. 45
Internal and External Batteries....................................................................... 45
Clock Battery ................................................................................................. 45
Alarm Battery................................................................................................. 45
11 Technical Troubleshooting................................................................................... 46
12 Suggested Acceptance Test................................................................................. 48
13 Appendices............................................................................................................ 49
Emissions and Immunity Declaration ............................................................. 49
Returning Products to Breas .......................................................................... 49
Patient Settings Record ................................................................................. 50
Inspection record template............................................................................. 51
Optional Accessories ..................................................................................... 53

Introduction 4
2210.2657 Rev 3.0 NIPPY Clearway 2 Service Manual .
1 Introduction
This Chapter gives an overview of the Clearway 2 airway clearance device and this
service manual.
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
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
The Clearway 2 airway clearance device assists patients in loosening,
mobilising, and clearing secretions, as well as promoting lung volume
recruitment.

5Introduction
NIPPY Clearway 2 Service Manual 2210.2657 Rev 3.0
The Clearway 2 must only be used under the direction and
prescription of a physician, respiratory therapist, or other
qualified persons.
Service Personnel Training Requirements
Service personnel working with the Clearway 2 shall have medical and or
technical training and have a good knowledge of the construction and function
of respiratory devices. Service personnel wishing to undertake service or repair
of the Clearway 2 shall first undertake a technical training course provided by
Breas Medical Ltd.
Please contact Breas Medical Ltd if training is required or if you
have any questions related to servicing of the device
About this Manual
Always read this manual in full before attempting any service
or repair of the Clearway 2. Service personnel are advised to
read the clinical instructions for use and use them in
conjunction with this technical manual
Intended Audience
This technical manual is intended for service technicians who have medical and
or technical training and who have a good knowledge of the construction and
function of respiratory devices.
•Patients and lay caregivers may read the User Manual (document
2658) for reference purposes, after appropriate guidance from the
responsible care provider
•Care providers and prescribing physicians such as doctors, clinicians,
physiotherapists, etc. may read the Clinical Manual (document 2656)
for clinical use guidance of the device

Introduction 6
2210.2657 Rev 3.0 NIPPY Clearway 2 Service Manual .
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

7Maintenance Instructions
NIPPY Clearway 2 Service Manual 2210.2657 Rev 3.0
2 Maintenance Instructions
WARNING!
Clearway 2 must be:
•Subjected to regular inspection and any applicable upgrades
in accordance with Breas Medical Ltd service instructions
•Repaired in accordance with this technical manual, technical
bulletins and any special service instructions, by trained
service technicians
Deviation from these instructions may lead to risk of personal injury
Purpose
Carrying out regular inspection and preventative maintenance at the intervals
specified in this manual will ensure that the Clearway 2 will continue to
perform to specification during its service lifetime.
Introduction
Please read the safety precautions and ensure you have all the necessary
equipment, tools and parts available before attempting any maintenance
procedures.

Maintenance Instructions 8
2210.2657 Rev 3.0 NIPPY Clearway 2 Service Manual .
WARNING! Safety Precautions
•Follow the safety precautions when working on the Clearway 2
•Do not work on the Clearway 2 with the case open and the
power supply connected, unless instructed to do so in this
manual
•Always use extreme caution when working on the Clearway 2
when connected to any power source with the case open
•Do not use explosive gases and / or fluids near the Clearway 2
•Make sure that all precautions to prevent electrostatic discharge
(ESD) have been taken
Service Schedule
An inspection of the Clearway 2 (described in this chapter) is
advised to be carried out at least every 12 months.
Interval
Procedure
Every 12 months
Perform an external inspection
Change the air inlet filter material
Perform a function test
Perform an electrical safety test
Every 5 Years
Perform the 12 month checks,
plus:
Change the clock battery
Change the alarm battery
Perform an internal inspection
Clean the valve
Every 15000 blower hours
Change the blower

9Maintenance Instructions
NIPPY Clearway 2 Service Manual 2210.2657 Rev 3.0
Inspection Equipment and Tools
The following equipment is required to perform an inspection on the
Clearway 2:
•Gas flow analyser.
or
•Manometer capable of measuring at least ±70 cmH2O (± 68.6 hPa) (±
0.75%) and a flow meter capable of measuring at least 300 sl/m (± 2%).
•70% Alcohol cleaning wipes
•Test Lung (part no 6011)
•6mm leak port (part no 00997)
•Clearway Breathing Circuit (part no 0960.101)
•Medical Electrical Safety tester
The following tools are required to open the case, remove and replace
components when necessary:
•Torx screwdriver T15 x 200mm (To open the case)
•Pozidrive screwdriver No. 1
•Hex screwdriver 2mm
•Hex screwdriver 2.5mm (To open the battery cover)
•Soldering iron, to remove and replace the alarm battery every 5 years

Maintenance Instructions 10
2210.2657 Rev 3.0 NIPPY Clearway 2 Service Manual .
Replacement Parts
The following parts should be available when performing service on the
Clearway 2.
Part
Part number
When required
Air inlet filter White
2210.3001
12 months
Air inlet filter Grey
2210.3000
As Required
Alarm battery
3/V110H
5 Years
Clock battery
002129
5 Years
Blower
2210.U51D2
15000 hours
Preparing for Inspection
Clean the case exterior using 70% alcohol cleaning wipes.
Inspection record
(see Inspection record template, Appendix 13.4)
Record the serial number
Record the blower hours run
Record / save the patient settings as required
Determine the level of service required
Labels and markings
Labels and markings should be attached and fully legible:
Front panel markings.
Information label on rear panel

11 Maintenance Instructions
NIPPY Clearway 2 Service Manual 2210.2657 Rev 3.0
External Inspection
Visual inspection
Inspect the case for signs of damage. Parts must be replaced if fixings have
failed affecting the case integrity, or the case has become damaged causing
internal parts to be accessible.
Inspect the filter housing, it should be attached securely to the rear case.
Inspect the integrity of front switch.
Inspect the patient outlet.
The internal battery cover must be fitted and secured with 3 screws
(countersunk M4x6mm).
Inspect the condition of the rear sockets (hand control, external battery and
mains inlet).
Inspect the condition of the side sockets and cover (USB, SD card slot and
SpO2 sensor socket).
Power Connection
Inspect the AC Mains cable and the Clearway 2 AC inlet socket.
Accessories
Inspect any accessories returned with the Clearway 2.
Changing / Cleaning the air filter material
Change the white filter material (2210.3001)
Clean or Change the grey filter material as necessary (2210.3000)

Maintenance Instructions 12
2210.2657 Rev 3.0 NIPPY Clearway 2 Service Manual .
Function test
Accessories made available at time of testing shall also be function checked.
Pressure and Flow Test
Connect the Clearway 2 patient outlet to a manometer or gas flow analyser via
a breathing circuit (part 2210.101) and connect a test lung (part 6011) to the
measurement devices outlet.
Select Manual Mode.
Set Insufflation to 40 cmH2O and Exsufflation to -40 cmH2O.
Use the front switch to activate Insufflation (+) and Exsufflation (-).
Verify that the measured value is within ± 3.5 cmH2O of set value.
If the reading is out of specification perform a calibration. (see Chapter 3)

13 Maintenance Instructions
NIPPY Clearway 2 Service Manual 2210.2657 Rev 3.0
Remove the test lung and replace with a 6mm leak (part no. 00997).
Use the front switch to activate Exsufflation (-) a number of times
Compare the value on the flow meter with the CPF value displayed on screen
(value updates when the switch is released.)
Displayed and measured values must be within ± 10 % of each other.
Hand control (when used)
Attach the breathing circuit (part 2210.101) and test lung (part 6011) to the
patient outlet.
Select Manual Mode and ensure that the remote hand control switch activates
insufflation and exsufflation appropriately. The Start/Stop button must start
or stop a treatment in the Auto Modes only.

Maintenance Instructions 14
2210.2657 Rev 3.0 NIPPY Clearway 2 Service Manual .
Internal and External battery (when used)
When using an internal or external battery it must be verified that the Clearway
2 will switch to battery power when the AC mains supply is removed and the
appropriate power source indicator is displayed.
With battery connected, remove the AC mains supply. Verify that the AC
power LED indicator extinguishes and the correct battery LED indicator and
on-screen icon is displayed.
Pulse Oximetry (when used)
Connect the SpO2cable and sensor accessory to the SpO2socket on the side
of the Clearway 2, A message will appear indicating that the sensor is
connected. Verify that a “?” symbol is displayed next to SpO2when no signal
is present. When a simulated SpO2signal is present it must be displayed on
screen. The “sensor disconnected” message along with an audible alarm must
be produced when the cable is disconnected.
Mains fail
Ensure internal battery is removed (described in this manual)
Connect Clearway 2 to the mains and power on.
Disconnect the mains cable, the audible mains fail alarm shall sound. The
yellow LED on the front panel shall also flash. The power button may be used
to mute the alarm after the second beep. Replace the alarm battery if the alarm
fails to sound for this time or the volume is low. The Alarm battery must be
replaced every 5 years.

15 Maintenance Instructions
NIPPY Clearway 2 Service Manual 2210.2657 Rev 3.0
Internal inspection
WARNING!
Disconnect the AC mains supply before opening the Clearway 2
case
Observe ESD precautions when handling Printed Circuit Boards
Every 5 years or following a repair, perform the 12 month checks plus an
internal inspection detailed in this chapter.
Open the case as described in this manual.
Internal clean
Clean out any dust which may have accumulated inside the Clearway 2.
Inspect electrical connections
Visually inspect all internal electrical cables. Cable sheathing must be intact and
in good condition and ensure cables have not been damaged. Verify that all
connections are securely made.
Inspect mechanical fastenings
Ensure 5 x command/display PCB fixings are secure (M3 x 8)
Ensure 2 x front switch fixings are secure (M3 x 8)
Ensure 4 x power supply fixings are secure (M3 x 8)
Ensure 4 x valve assembly fixings are secure (M4 x 10)
Ensure 2 x fixings for rigid pipe are secure (M3 x 8)
Check cooling fan is fitted securely.
Check blower jacket is securely closed.
Check silicone pipes are all securely fitted to blower and valve.
Check pressure measurement pipes are securely connected.

Maintenance Instructions 16
2210.2657 Rev 3.0 NIPPY Clearway 2 Service Manual .
Clean the valve assembly
Every 5 years remove the valve assembly and clean as described in chapter 7
of this manual.
Electrical Safety
Clearway 2 is a Class II, type BF medical electrical device.
Electrical equipment with dual isolation and body floating (isolated) applied
parts according to IEC 60601-1.
Regularly Inspect the AC mains cable and plug (part number: 2210.2701)
Electrical safety testing shall be carried out by persons experienced in the
electrical safety testing of medical devices and performed in accordance with
IEC 60601-1 or IEC 62353. A medical electrical safety tester shall be used to
test the Clearway 2.
It is recommended to carry out an electrical safety test at least
every 12 months
It is recommended to test:
•Insulation Resistance
•Leakage Currents:
oEnclosure leakage current (touch current)
oPatient applied part leakage current

17 Service Menu
NIPPY Clearway 2 Service Manual 2210.2657 Rev 3.0
3 Service Menu
Introduction
The service menu is used to set date and time, perform calibration of pressure
and flow and provides diagnostic screens for detailed analysis of machine
functions.
Selecting Languages
The language used may be selected under Main Menu – User
Preferences. Service screens are in English language only.
Unlocking the Clearway 2
Unlock by holding the padlock icon until a pop up appears and
acknowledge it. Clearway 2 must always be unlocked before accessing
the service menu.
To Enter the Service Mode:
Press the menu button and select service menu, input the code 4321 and
press the tick button.
Set Time and Date
Setting the correct time and date is important to ensure that the logged events
and alarms are accurately recorded:
Enter the Service Menu and select Date and Time.
Use the up and down arrows above and below the values to change
them.

Service Menu 18
2210.2657 Rev 3.0 NIPPY Clearway 2 Service Manual .
Calibration
Pressure and Flow Calibration
If the pressure and flow checks carried out in section 2 indicate that the
Clearway 2 requires calibration:
Select an MI-E mode (Basic Auto or Prog Auto)
1. Enter the service menu and select ‘begin calibration’.
Press ‘Next’ to move to the next window.
(To exit at anytime press the Blue square with arrows pointing
inwards.)
2. Zero the transducer values, by pressing the ‘ZERO’ buttons (in any
order), then press ‘Next’

19 Service Menu
NIPPY Clearway 2 Service Manual 2210.2657 Rev 3.0
3. Connect the Pressure measurement device.
4. Press ‘Start Blower’ [1] and Adjust P1 and P2 by pressing the
corresponding [-] and [+] buttons [2][3] until they match the pressure
measurement device reading. Press ‘STOP’ [4] to stop the blower.
Then press ‘Next’.
NOTE: The blower will default to creating a pressure of around 45
cmH2O, we recommended to calibrate this point. It is only required
to calibrate this one point.

Service Menu 20
2210.2657 Rev 3.0 NIPPY Clearway 2 Service Manual .
5. Attach your flow meter or remove occlusion from the gas flow
analyzer. Fit a 6mm leak port (part no. 00997) to the measurement
device outlet.
6. Press ‘Start Blower’ [1] and Adjust F1 using corresponding [-] and [+]
buttons [2] until it matches the flow measurement device reading.
Press ‘STOP’ [3] to stop the blower, then press ‘Next’.
NOTE: With the 6mm leak, the blower will default to a flow of
around -160 L/m, we recommend to calibrate this point. It is only
required to calibrate this one point.