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
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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
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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
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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.
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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
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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.
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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
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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)
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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
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