Bayer HealthCare Breelib Bedienungsanleitung

Packaging Technology Berlin SGQWX Bayer AG

client: 0021,GVDE material-no.: 86886863 PZ: 2780A-2 code-no.:

Reference-Code: 08CN0109 IFU date: 210319

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

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

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

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

colors: Black / cyan / magenta / yellow

version: 28.03.2019/01 Restricted Document dimension: 210 x 148 mm

page: 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

colors: Black / cyan / magenta / yellow

version: 28.03.2019/01 Restricted Document dimension: 210 x 148 mm

page: 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

colors: Black / cyan / magenta / yellow

version: 28.03.2019/01 Restricted Document dimension: 210 x 148 mm

page: 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

colors: Black / cyan / magenta / yellow

version: 28.03.2019/01 Restricted Document dimension: 210 x 148 mm

page: 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

colors: Black / cyan / magenta / yellow

version: 28.03.2019/01 Restricted Document dimension: 210 x 148 mm

page: 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

colors: Black / cyan / magenta / yellow

version: 28.03.2019/01 Restricted Document dimension: 210 x 148 mm

page: 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

Andere Handbücher für Breelib

Inhaltsverzeichnis

Andere Bayer HealthCare Medizinische Geräte Handbücher

Bayer HealthCare

Bayer HealthCare MEDRAD MRXperion Bedienungsanleitung

Bayer HealthCare

Bayer HealthCare Medrad Spectris Solaris EP Montageanleitung

Bayer HealthCare

Bayer HealthCare MEDRAD Stellant Bedienungsanleitung

Bayer HealthCare

Bayer HealthCare Temprid 75 Bedienungsanleitung

Bayer HealthCare

Bayer HealthCare Certegra Bedienungsanleitung

Bayer HealthCare

Bayer HealthCare MEDRAD MRXperion Bedienungsanleitung

Bayer HealthCare

Bayer HealthCare MEDRAD Salient ZY6320 Bedienungsanleitung

Bayer HealthCare

Bayer HealthCare ADVIA 60 Handbuch

Bayer HealthCare

Bayer HealthCare CHIPCO 26019 N Bedienungsanleitung

Bayer HealthCare

Bayer HealthCare MEDRAD Avanta Bedienungsanleitung

Bayer HealthCare

Bayer HealthCare Certegra P3T PA Bedienungsanleitung

Bayer HealthCare

Bayer HealthCare MICROLET 2 Bedienungsanleitung

Bayer HealthCare

Bayer HealthCare MEDRAD Stellant Technisches Datenblatt

Bayer HealthCare

Bayer HealthCare CERTEGRA MEDRAD Stellant FLEX Bedienungsanleitung

Bayer HealthCare

Bayer HealthCare MEDRAD Stellant Bedienungsanleitung

Bayer HealthCare

Bayer HealthCare Breelib Handbuch

Bayer HealthCare

Bayer HealthCare Rapidlab 800 Bedienungsanleitung

Bayer HealthCare

Bayer HealthCare MEDRAD Twist & Go Bedienungsanleitung

Bayer HealthCare

Bayer HealthCare MEDRAD MRXperion Bedienungsanleitung

Bayer HealthCare

Bayer HealthCare MEDRAD MRXperion XP 65/115VS Bedienungsanleitung

Bayer HealthCare

Bayer HealthCare Breelib Handbuch

Bayer HealthCare

Bayer HealthCare MEDRAD Avanta Bedienungsanleitung

Bayer HealthCare

Bayer HealthCare MEDRAD CT 300 Series Bedienungsanleitung

Bayer HealthCare

Bayer HealthCare MEDRAD Stellant SDS-TRF-CV Bedienungsanleitung

Beliebte Medizinische Geräte Handbücher anderer Marken

TekTone

TekTone Tek-CARE160 Bedienungsanleitung

NeuroMetrix

NeuroMetrix Quell 2.0 Bedienungsanleitung

AMT

AMT XLR8 Bedienungsanleitung

EDAN

EDAN SONOTRAX Pro Bedienungsanleitung

Restorative Therapies

Restorative Therapies RT300 Bedienungsanleitung

Gendex

Gendex Expert DC Bedienungsanleitung

Dexcowin

Dexcowin ADX4000W Bedienungsanleitung

Libelium

Libelium MySignals Bedienungsanleitung

Acelity

Acelity V.A.C.ULTA 4 Bedienungsanleitung

Caputron

Caputron ActivaDose II tDCS Bedienungsanleitung

Plinth 2000

Plinth 2000 93CDT Bedienungsanleitung

GE SENOGRAPHE 800T Bedienungsanleitung

GE Definium 5000 Bedienungsanleitung

Kanmed

Kanmed GE-1380 Bedienungsanleitung

Huntleigh

Huntleigh FD1 Bedienungsanleitung

Stryker

Stryker SPR Plus Bedienungsanleitung

Tobii Dynavox

Tobii Dynavox I-Series Bedienungsanleitung

S-Capepod

S-Capepod Evac Cocoon Bedienungsanleitung