Bayer HealthCare Breelib User manual

Packaging Technology Berlin SGQWX Bayer AG
client: 0021,GVDE material-no.: 86886863 PZ: 2780A-2 code-no.:
Reference-Code: 08CN0109 IFU date: 210319
name: LF-BRO-Breelib Inhaler Starter Kit country: GB/-/-
colors: Black / cyan / magenta / yellow
version: 28.03.2019/01 Restricted Document dimension: 210 x 148 mm
page: U 1
Inhalation System
Instructions for Use
86886863_01.indd 1 3/28/2019 11:16:35 AM

Packaging Technology Berlin SGQWX Bayer AG
client: 0021,GVDE material-no.: 86886863 PZ: 2780A-2 code-no.:
Reference-Code: 08CN0109 IFU date: 210319
name: LF-BRO-Breelib Inhaler Starter Kit country: GB/-/-
colors: Black / cyan / magenta / yellow
version: 28.03.2019/01 Restricted Document dimension: 210 x 148 mm
page: U 2
86886863_01.indd 2 3/28/2019 11:16:35 AM

Packaging Technology Berlin SGQWX Bayer AG
client: 0021,GVDE material-no.: 86886863 PZ: 2780A-2 code-no.:
Reference-Code: 08CN0109 IFU date: 210319
name: LF-BRO-Breelib Inhaler Starter Kit country: GB/-/-
colors: Black / cyan / magenta / yellow
version: 28.03.2019/01 Restricted Document dimension: 210 x 148 mm
page: U 3
86886863_01.indd 3 3/28/2019 11:16:35 AM

210319
08CN0109
Packaging Technology Berlin SGQWX Bayer AG
client: 0021,GVDE material-no.: 86886863 PZ: 2780A-2 code-no.:
Reference-Code: 08CN0109 IFU date: 210319
name: LF-BRO-Breelib Inhaler Starter Kit country: GB/-/-
colors: Black / cyan / magenta / yellow
version: 28.03.2019/01 Restricted Document dimension: 210 x 148 mm
page: U 4
86886863
Vectura Group plc
One Prospect West
Chippenham, Wiltshire,
SN14 6FH
United Kingdom
www.vectura.com
Vectura Ireland Limited
The Brickhouse Block 1,
Clanwilliam Court,
Lower Mount Street
Dublin, D02 CF97, Ireland
0123
86886863_01.indd 4 3/28/2019 11:16:36 AM

Packaging Technology Berlin SGQWX Bayer AG
client: 0021,GVDE material-no.: 86886863 PZ: 2780A-2 code-no.:
Reference-Code: 08CN0109 IFU date: 210319
name: LF-BRO-Breelib Inhaler Starter Kit country: GB/-/-
colors: Black / cyan / magenta / yellow
version: 28.03.2019/01 Restricted Document dimension: 210 x 148 mm
page: 1
1
DEFINITIONS
Definitions
The following definitions are used throughout this document.
Please read these paragraphs carefully.
Warning
RIndicates a potentially hazardous situation which, if not
avoided, could result in a life-threatening injury.
Caution
RIndicates a potentially hazardous situation which, if not
avoided, may result in minor or moderate injury. This signal
word may also be used to highlight unsafe practices or
potential equipment damage.
User Assistance Information
For any questions relating to your Breelib™ Inhalation System
please refer to the Contact Details on the back cover of this
Instructions for Use.
86886863_01.indd 1 3/28/2019 11:16:36 AM

Packaging Technology Berlin SGQWX Bayer AG
client: 0021,GVDE material-no.: 86886863 PZ: 2780A-2 code-no.:
Reference-Code: 08CN0109 IFU date: 210319
name: LF-BRO-Breelib Inhaler Starter Kit country: GB/-/-
colors: Black / cyan / magenta / yellow
version: 28.03.2019/01 Restricted Document dimension: 210 x 148 mm
page: 2
2
CONTENT
Content
1. Safety Instructions 3
2. Terms 4
3. Intended Use 5
4. Description 5
4.1. Package Content 5
4.2. LEDs and Buttons 7
4.3. Inhalation System 8
5. Before first Use 9
5.1. Charge the Base Unit 9
6. Preparing for Treatment 11
6.1. General Treatment Guidelines 11
6.2. Assembling 12
6.3. Fill the Nebuliser Unit with VENTAVIS® 13
6.4. Switch the Base Unit ON/OFF 14
7. Take a Treatment 16
7.1. General Inhalation Guidelines 16
7.2. Inhalation Feedback 17
7.3. Inhaling 18
7.4. Automatic Wireless Connection after each
Treatment 19
8. Maintenance 20
8.1. Disassembling 20
8.2. Cleaning and Disinfection 20
8.3. Storage and Transportation 28
Content
9. Initial Pairing via Wireless Connection 29
10. Troubleshooting 30
10.1. Error Messages 30
10.2. Resetting the Hardware 33
11. Technical Data 34
11.1. General 34
11.2. Aerosol Characteristics 35
11.3. Accessories and Spare Parts 35
11.4. Service Life 36
11.5. Environmental Conditions for Use 36
11.6. Environmental Conditions for Storage and
Transportation 36
11.7. Electrical Safety Information 36
11.8. Radio Frequency Information 36
11.9. Electromagnetic Compatibility 37
11.10. Recycling and Disposal 42
12. Warranty 43
13. Explanation of Symbols 43
86886863_01.indd 2 3/28/2019 11:16:37 AM

Packaging Technology Berlin SGQWX Bayer AG
client: 0021,GVDE material-no.: 86886863 PZ: 2780A-2 code-no.:
Reference-Code: 08CN0109 IFU date: 210319
name: LF-BRO-Breelib Inhaler Starter Kit country: GB/-/-
colors: Black / cyan / magenta / yellow
version: 28.03.2019/01 Restricted Document dimension: 210 x 148 mm
page: 3
3
1. SAFETY INSTRUCTIONS
1. Safety Instructions
Always have these instructions for use ready at hand. It is part
of Breelib™ Inhalation System and a requirement for the
intended use.
Before you use the Breelib™ you must fully read and understand
these instructions for use.
Warning
RRead the entire instructions for use before operating the
Breelib™. Correct and safe operation can only be achieved if
these instructions for use are followed. Incorrect usage may
reduce the effect of the treatment.
RKeep these instructions for future reference.
RUse the Breelib™ only for its intended use as described in
these instructions for use (refer to chapter “3. Intended Use“
on page 5).
RUse the Breelib™ only when prescribed by a physician and
only with the drug prescribed for the Breelib™.
RDo not use any drug other than VENTAVIS® for Breelib™. The
use of other drugs can lead to serious risks to health or can
damage the Breelib™.
RDo not share your Breelib™ with other people. It can lead to
infections. The Breelib™ is designed for single patient use.
REnsure the Breelib™ has been properly cleaned and
disinfected before use.
RDo not use the consumables of the monthly pack for more
than one month to maintain constant performance.
RThe Breelib™ is not designed for emergency and life support
use.
RDo not use the Breelib™ if it is damaged or modified. Only
use accessories supplied by an service partner.
ROnly Vectura Group plc or a service partner authorised by
Vectura Group plc is permitted to repair the Breelib™.
Vectura Group plc is not liable for any damage or
malfunction as a result of incorrect use.
RDo not open or disassemble the base unit. It may cause
damage that is not covered by this warranty.
RDo not use any left-over drug for further therapies.
RKeep the Breelib™ away from small children to prevent
contamination.
RKeep the Breelib™ away from small children to prevent
strangulation with the charger cable.
86886863_01.indd 3 3/28/2019 11:16:37 AM

Packaging Technology Berlin SGQWX Bayer AG
client: 0021,GVDE material-no.: 86886863 PZ: 2780A-2 code-no.:
Reference-Code: 08CN0109 IFU date: 210319
name: LF-BRO-Breelib Inhaler Starter Kit country: GB/-/-
colors: Black / cyan / magenta / yellow
version: 28.03.2019/01 Restricted Document dimension: 210 x 148 mm
page: 4
4
2. TERMS
Caution
RSpecial precautions are needed for the Breelib™ regarding
EMC (electromagnetic compatibility). It needs to be used
according to the EMC information provided in chapter
“11.9.Electromagnetic Compatibility” on page37.
RThe Breelib™ may be affected by portable or mobile RF
(radio frequency) communication equipment like mobile
phones or computer equipment. In case of a malfunctioning
base unit, increase distance to portable or mobile RF
communication equipment. For detailed information, refer
to chapter “11.9. Electromagnetic Compatibility” on
page37.
2. Terms
Used term Description
Breelib™ Inhalation system to nebulise the
VENTAVIS® inhalation solution
PAH Pulmonary arterial hypertension
VENTAVIS® Inhalation solution
Base unit Component containing the hardware
Mouthpiece Component for inhaling VENTAVIS®
Nebuliser unit Component for generating VENTAVIS®
aerosol
Monthly pack Reusable nebuliser unit + mouthpiece
Drug dosing system System for dosing VENTAVIS®
Membrane Component of nebuliser unit that
generates aerosol of the drug
Pulsing LED The LED pulses slowly
Blinking LED The LED flashes quickly
Illuminated LED The LED is constantly lit
Glass ampoule VENTAVIS® drug in a glass container
RF Radio frequency
86886863_01.indd 4 3/28/2019 11:16:37 AM

Packaging Technology Berlin SGQWX Bayer AG
client: 0021,GVDE material-no.: 86886863 PZ: 2780A-2 code-no.:
Reference-Code: 08CN0109 IFU date: 210319
name: LF-BRO-Breelib Inhaler Starter Kit country: GB/-/-
colors: Black / cyan / magenta / yellow
version: 28.03.2019/01 Restricted Document dimension: 210 x 148 mm
page: 5
5
3. INTENDED USE
3. Intended Use
The Breelib™ Inhalation System is a breath
activated vibrating mesh nebuliser with passive flow and active
volume control. It is designed to be used for oral inhalation of
VENTAVIS® nebuliser solution.
The Breelib™ Inhalation System ensures precise drug dosage
and targeting of VENTAVIS®.
The Breelib™ is intended to be used by adult, conscious,
cooperative patients, who can control their breathing. The
patient may use the device outside a professional healthcare
facility (home use environment). It is intended for single patient
use only.
Guidelines for Reuse
The components of Breelib™ can be reused, only if they are
handled carefully and free of damage.
Vectura Group plc shall not be held liable for any damages or
consequential damages, consequences for safety, reliability and
performance of the device when using dirty or damaged
components.
For hygienic and performance reasons use the nebuliser unit
and the mouthpiece of the monthly pack for one month only.
For more details on the cleaning process, refer to chapter
“8.2.Cleaning and Disinfection” on page 20.
4. Description
Caution
If any of the components are missing, damaged or
incomplete, contact your Breelib™ service partner or
prescribing physician.
4.1. Package Content
Ensure the starter pack contains:
RInstructions for use
RQuick reference card
RCarry case including base unit
RCharger
RMonthly pack (nebuliser unit + mouthpiece)
86886863_01.indd 5 3/28/2019 11:16:37 AM

Packaging Technology Berlin SGQWX Bayer AG
client: 0021,GVDE material-no.: 86886863 PZ: 2780A-2 code-no.:
Reference-Code: 08CN0109 IFU date: 210319
name: LF-BRO-Breelib Inhaler Starter Kit country: GB/-/-
colors: Black / cyan / magenta / yellow
version: 28.03.2019/01 Restricted Document dimension: 210 x 148 mm
page: 6
6
4. DESCRIPTION
Starter pack
ACarry case including base unit
B Charger
CMonthly pack
Nebuliser unit
ACap
BDrug dosing system
CNebuliser body
DMouthpiece
86886863_01.indd 6 3/28/2019 11:16:37 AM

Packaging Technology Berlin SGQWX Bayer AG
client: 0021,GVDE material-no.: 86886863 PZ: 2780A-2 code-no.:
Reference-Code: 08CN0109 IFU date: 210319
name: LF-BRO-Breelib Inhaler Starter Kit country: GB/-/-
colors: Black / cyan / magenta / yellow
version: 28.03.2019/01 Restricted Document dimension: 210 x 148 mm
page: 7
7
4. DESCRIPTION
EBase unit, battery powered
To use the Breelib™ you also need:
RDistilled water for cleaning
RWashing-up liquid without skin care additives (for example
balsam) or disinfectant properties for washing
RUse standard washing-up liquid (for manual dish washing,
neutral pH between 6 and 8)
RClean, dry and lint-free paper towels for drying
RVENTAVIS®
4.2. LEDs and Buttons
The LEDs on the base unit indicate the current state of the
Breelib™.
If no LEDs light up, the base unit is either switched OFF and/or
the battery is flat.
The following table contains a description of all LEDs and
buttons.
A ON/OFF button
For more details on switching the Breelib™ ON and OFF, refer
to chapter "6.4. Switch the Base Unit ON/OFF" on page14.
B Wireless Connection LED
Constant blue Connection successful.
Blinking blue Connection in progress.
Fast blinking blue Connection failed.
86886863_01.indd 7 3/28/2019 11:16:38 AM

Packaging Technology Berlin SGQWX Bayer AG
client: 0021,GVDE material-no.: 86886863 PZ: 2780A-2 code-no.:
Reference-Code: 08CN0109 IFU date: 210319
name: LF-BRO-Breelib Inhaler Starter Kit country: GB/-/-
colors: Black / cyan / magenta / yellow
version: 28.03.2019/01 Restricted Document dimension: 210 x 148 mm
page: 8
8
4. DESCRIPTION
C Reset button
To reset the hardware, refer to chapter "10.2. Resetting the
Hardware" on page 33.
D Auto-test LED
All LEDs are
illuminated for a
short time
Auto-test is in progress.
E Power LED
Constant green Battery is fully charged (refer to
chapter "6.4. Switch the Base Unit
ON/OFF" on page 14).
Pulsing green Battery is charging.
Constant orange Charge the battery of the base unit
after the next treatment.
Slow blinking
orange
Charge the battery of the base unit
before the next treatment.
F Mouthpiece LED
Constant green Inhalation mode (refer to chapter
"7.1. General Inhalation Guidelines"
on page 16).
Blinking green Treatment is finished (refer to
chapter "7.1. General Inhalation
Guidelines" on page 16).
Constant
orange
Operating error:
Incorrect use.
Breelib™ is still powered on (refer to
chapter "7.1. General Inhalation
Guidelines" on page 16)
Blinking orange Device error:
Breelib™ turns off. (refer to chapter
"7.1. General Inhalation Guidelines"
on page 16)
4.3. Inhalation System
This chapter describes the functionality of the Breelib™ and how
to correctly take a treatment. The Breelib™ is a breath-actuated
inhalation system. It controls flow and volume to ensure precise
drug dosage and targeting for effective drug therapy.
The device contains a flow-dependent valve, which limits the
rate of the airflow.
For a successful treatment you must inhale and exhale several
times at a moderate rate.
To ensure that you inhale and exhale at a moderate rate the
Breelib™ pauses for 1 second between each inhalation. If you
pause for more than 5 minutes, the Breelib™ turns off. If you
have successfully completed a treatment, the mouthpiece LED
blinks green for 5 seconds. For a step-by-step instruction on
how to correctly take a treatment, refer to chapter “7. Take a
Treatment” on page 16.
4.3.1. VENTAVIS® Aerosol Generation
The vibrating membrane on the under side of the nebuliser unit
generates an aerosol out of the VENTAVIS® inhalation solution.
The patient will inhale this aerosol when breathing through the
Breelib™.
86886863_01.indd 8 3/28/2019 11:16:38 AM

Packaging Technology Berlin SGQWX Bayer AG
client: 0021,GVDE material-no.: 86886863 PZ: 2780A-2 code-no.:
Reference-Code: 08CN0109 IFU date: 210319
name: LF-BRO-Breelib Inhaler Starter Kit country: GB/-/-
colors: Black / cyan / magenta / yellow
version: 28.03.2019/01 Restricted Document dimension: 210 x 148 mm
page: 9
9
5. BEFORE FIRST USE
There will be no aerosol generation if the patient is not
breathing through the Breelib™.
Caution
Do not touch or clean the
membrane located on the
under side of the nebuliser unit
with abrasive materials. Avoid
touching the membrane during
the cleaning procedure
because it is damaged easily.
Replace any broken, misshapen
or seriously discoloured parts.
4.3.2. Drug Dosing System
In order to correctly dose VENTAVIS®, the nebuliser unit contains
a drug dosing system which ensures that the correct amount of
VENTAVIS® is released.
When the cap is closed, the integrated piston located in the cap
of the nebuliser unit pushes the correct amount of VENTAVIS®
through a valve into the lower part of the nebuliser unit. There
is a mechanism inside the dosing system that will retain the
left-over drug.
5. Before First Use
Warning
RThe first use of the components must not be after the “1st
use before” date on the outer packaging.
RIf the “1st use before” date marked on the outer packaging
has passed, contact your Breelib™ service partner.
RUnpack all components of the starter pack.
RCharge the base unit battery completely before using. For
further details, refer to chapter “5.1. Charge the Base Unit”.
5.1. Charge the Base Unit
The base unit battery must be fully charged before using the
Breelib™ for the first time.
Warning
RDo not use any other charger. Using another Charger or
Accessory may damage, lead to increased emissions or
decreased immunity of the Breelib™ Inhalation System.
RDo not use an outlet, if the voltage on the outlet exceeds
the specification on the charger. When travelling, use a
suitable power socket adapter.
Caution
RYou cannot take a treatment while the base unit is
connected to the charger.
RThe minimum charging time for one treatment is
10-15minutes.
86886863_01.indd 9 3/28/2019 11:16:38 AM

Packaging Technology Berlin SGQWX Bayer AG
client: 0021,GVDE material-no.: 86886863 PZ: 2780A-2 code-no.:
Reference-Code: 08CN0109 IFU date: 210319
name: LF-BRO-Breelib Inhaler Starter Kit country: GB/-/-
colors: Black / cyan / magenta / yellow
version: 28.03.2019/01 Restricted Document dimension: 210 x 148 mm
page: 10
10
5. BEFORE FIRST USE
RShade the power LED with your hands when in bright light
conditions, so that you can clearly see whether the power
LED pulses green or is brightly lit.
RCharge the Breelib™ when the power LED is orange or
blinking orange.
There are five different states of charge indicated by the power
LED:
Constant green Battery is fully charged.
Pulsing green Battery is charging.
Constant orange Charge the battery of the
base unit after the next
treatment.
Slow blinking orange Charge the battery of the
base unit before the next
treatment.
Slow blinking orange and
slow blinking orange
mouthpiece
After the end of the
treatment, low battery state
is visible for 2 minutes.
Charge the battery of the
base unit immediately.
To charge the base unit battery, follow these steps:
RPlace the Breelib™ on a dry horizontal surface.
RPlug the connector into the socket inlet of the base unit.
RConnect the charger to the power outlet.
RThe power LED will pulse green when charging.
RWhen the power LED is constantly lit green, the battery is
fully charged and you must unplug the charger from the
base unit.
86886863_01.indd 10 3/28/2019 11:16:39 AM

Packaging Technology Berlin SGQWX Bayer AG
client: 0021,GVDE material-no.: 86886863 PZ: 2780A-2 code-no.:
Reference-Code: 08CN0109 IFU date: 210319
name: LF-BRO-Breelib Inhaler Starter Kit country: GB/-/-
colors: Black / cyan / magenta / yellow
version: 28.03.2019/01 Restricted Document dimension: 210 x 148 mm
page: 11
11
6. PREPARING FOR TREATMENT
RDisconnect the charger from the mains.
The Breelib™ is now ready for use.
3
RDisconnect the charger from the device and the power outlet.
You can not take a treatment while the charger is connected
to the device.
RThe Breelib™ is now ready for use.
Continue by preparing the treatment. Refer to chapter
„6.Preparing for Treatment“.
6. Preparing for Treatment
6.1. General Treatment Guidelines
Follow these steps sequentially and exactly as described to
ensure proper use of the Breelib™.
Step Chapter
RCharge the base unit. "5.1. Charge the Base Unit" on
page 9
RAssemble the Breelib™."6.2. Assembling" on
page12
RFill the nebuliser unit with
VENTAVIS®.
"6.3. Fill the Nebuliser Unit
with VENTAVIS®" on
page13
RSwitch the base unit ON. "6.4. Switch the Base Unit
ON/OFF" on page 14
RTake a treatment. "7. Take a Treatment" on
page16
RDisassemble the Breelib™."8.1. Disassembling" on
page20
RRinse the components
immediately after each use.
"8.2.2. Rinse the Components"
on page 21
RClean the components
(weekly).
"8.2.3. Clean the Components
(Weekly)" on page 24
RDisinfect the components
(weekly).
"8.2.4. Disinfect the
Components (Weekly)" on
page 26
RDry the components. "8.2.5. Dry the Components"
on page 27
86886863_01.indd 11 3/28/2019 11:16:39 AM

Packaging Technology Berlin SGQWX Bayer AG
client: 0021,GVDE material-no.: 86886863 PZ: 2780A-2 code-no.:
Reference-Code: 08CN0109 IFU date: 210319
name: LF-BRO-Breelib Inhaler Starter Kit country: GB/-/-
colors: Black / cyan / magenta / yellow
version: 28.03.2019/01 Restricted Document dimension: 210 x 148 mm
page: 12
12
6. PREPARING FOR TREATMENT
6.2. Assembling
Caution
REnsure that each component of the Breelib™ is clean (refer
to chapter “8.2. Cleaning and Disinfection” on page20),
dry and not damaged. Check for misshapen or broken
membrane and replace it immediately.
RIf the components feel loose when shaking after assembly,
disassemble and reassemble the Breelib™. If the problem
remains, contact your Breelib™ service partner.
To assemble the Breelib™, follow these steps:
RInsert the back end of the
mouthpiece into the base
unit.
RPress the mouthpiece
downwards.
RThe mouthpiece must be
latched into the base unit.
RInsert the nebuliser unit into
the base unit.
RPress the nebuliser unit down
until it latches into the base
unit.
Ensure that the arms are
clipped in on both sides.
REnsure that all components are correctly and firmly
connected.
Continue by filling the nebuliser unit with VENTAVIS®.Refer to
chapter “6.3. Fill the Nebuliser Unit with VENTAVIS®”.
86886863_01.indd 12 3/28/2019 11:16:39 AM

Packaging Technology Berlin SGQWX Bayer AG
client: 0021,GVDE material-no.: 86886863 PZ: 2780A-2 code-no.:
Reference-Code: 08CN0109 IFU date: 210319
name: LF-BRO-Breelib Inhaler Starter Kit country: GB/-/-
colors: Black / cyan / magenta / yellow
version: 28.03.2019/01 Restricted Document dimension: 210 x 148 mm
page: 13
13
6. PREPARING FOR TREATMENT
6.3. Fill the Nebuliser Unit with VENTAVIS®
Warning
RUse a new ampoule of VENTAVIS® for each treatment.
Always transfer the whole content of the ampoule into the
dosing system.
RDo not reinject more VENTAVIS® once you have filled the
nebuliser unit and closed the cap.
ROnce you have filled the nebuliser unit, keep the cap closed
until the end of the treatment.
The drug dosing system can be impaired when the cap is
re-opened/closed during treatment.
RDo not store or transport a filled Breelib™.
Caution
RBefore filling the nebuliser unit, make sure that the base
unit is not connected to the charger.
RAssemble the Breelib™ before filling the nebuliser unit with
VENTAVIS® (refer to chapter „6.2. Assembling“ on
page12).
To fill the nebuliser unit with VENTAVIS®, you will need a single-
use pipette. Follow these steps:
ROpen the glass ampoule.
RFill a single-use pipette with
VENTAVIS®.
86886863_01.indd 13 3/28/2019 11:16:39 AM

Packaging Technology Berlin SGQWX Bayer AG
client: 0021,GVDE material-no.: 86886863 PZ: 2780A-2 code-no.:
Reference-Code: 08CN0109 IFU date: 210319
name: LF-BRO-Breelib Inhaler Starter Kit country: GB/-/-
colors: Black / cyan / magenta / yellow
version: 28.03.2019/01 Restricted Document dimension: 210 x 148 mm
page: 14
14
6. PREPARING FOR TREATMENT
RTransfer all of the VENTAVIS®
with the pipette into the
centre of the drug dosing
system.
RCarefully close the cap of the
nebuliser unit. The correct
amount of the inhalation
solution will be
automatically pushed into
the nebuliser unit.
Your Breelib™ is now filled. Continue immediately by switching
the Breelib™ on and starting the inhalation procedure. For
details on how to switch the base unit on, refer to chapter
“6.4.Switch the Base Unit ON/OFF” on page14.
6.4. Switch the Base Unit ON/OFF
If the Breelib™ is connected to the charger, disconnect it. Ensure
that the nebuliser unit is filled with VENTAVIS®.
Caution
RAvoid switching the base unit off accidentally. If the base
unit is accidentally switched off, press the ON/OFF button
again.
RIf the base unit cannot be switched on and the nebuliser
unit is filled, dispose of any inhalation solution and rinse
the nebuliser unit (refer to chapter “8.2.2. Rinse the
Components” on page21.
RIf the power LED is orange or blinks orange, charge the
battery of the base unit after the next treatment. Please
refer to chapter 5.1 "Charge the base unit" on page 9 for
details.
RDo not inhale during the auto-test.
RIf the auto-test fails, the mouthpiece will blink orange and
a signal will sounds (“beep”). The Breelib™ will turn off.
Please refer to chapter “10.1. Error Messages” on page 30.
86886863_01.indd 14 3/28/2019 11:16:39 AM

Packaging Technology Berlin SGQWX Bayer AG
client: 0021,GVDE material-no.: 86886863 PZ: 2780A-2 code-no.:
Reference-Code: 08CN0109 IFU date: 210319
name: LF-BRO-Breelib Inhaler Starter Kit country: GB/-/-
colors: Black / cyan / magenta / yellow
version: 28.03.2019/01 Restricted Document dimension: 210 x 148 mm
page: 15
15
6. PREPARING FOR TREATMENT
To switch the base unit ON, follow these steps:
RPress the ON/OFF button.
RWait until the auto-test starts.
All LEDs and the mouthpiece are illuminated during the
auto-test.
RThe auto-test is finished when only the power LED is
illuminated. The Breelib™ clicks twice at the end of the auto-
test.
3
Your Breelib™ is switched ON. You can now take a treatment. To
continue, read the following chapter “7. Take a Treatment” on
page 16.
86886863_01.indd 15 3/28/2019 11:16:40 AM

Packaging Technology Berlin SGQWX Bayer AG
client: 0021,GVDE material-no.: 86886863 PZ: 2780A-2 code-no.:
Reference-Code: 08CN0109 IFU date: 210319
name: LF-BRO-Breelib Inhaler Starter Kit country: GB/-/-
colors: Black / cyan / magenta / yellow
version: 28.03.2019/01 Restricted Document dimension: 210 x 148 mm
page: 16
16
7. TAKE A TREATMENT
7. Take a Treatment
A complete treatment session with the Breelib™ consists of:
RThe inhalation system preparation,
RThe inhalation itself,
RAnd the signal for the end of treatment.
For a detailed description on how to inhale and exhale correctly,
refer to chapter “7.1. General Inhalation Guidelines”.
7.1. General Inhalation Guidelines
Caution
RDo not inhale additional air through your nose during
inhalation. If necessary, use a nose clip.
RDo not block the mouthpiece with your tongue during
inhalation.
RBreathe slowly to ensure a successful treatment and to
avoid inhalation solution waste.
RVery strong inhalation will cause the Breelib™ to decrease
the airflow.
RBefore you take a treatment, the base unit must be switched
on and the auto-test must be completed (power LED is
green).
RCheck the battery state before inhalation. For further details
on battery states, refer to chapter „5.1. Charge the Base Unit“
on page 9.
RHold the Breelib™
horizontally during
treatment. Holding the
Breelib™ at an angle might
impair performance. 15° tilt
is permitted.
86886863_01.indd 16 3/28/2019 11:16:40 AM