Bayer HealthCare Breelib DAW-00058-09 Instructions For Use Manual

Inhalation system

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Inhalation System

Instructions for Use

90428726_02.indd 1

Packaging Technology Berlin sgqwx

page: U 1

client: GVDE

material-no.: 90428726

Reference-Code: 500058R9

CMO-Code: DAW-00058-09

name: LF-BRO BREELIB INHALER STARTER PACK

colors:

Black /

CYAN /

MAGENTA /

YELLOW

version: 27.11.2023/02

Restricted Document

Bayer AG

PZ: 2780A-2

code-no.:

IFU date: 261023

country: GB/-/-

dimension: 210 x 148 mm

27.11.2023 13:00:36

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Summary of Contents for Bayer HealthCare Breelib DAW-00058-09

Page 1 Inhalation System Instructions for Use 90428726_02.indd 1 27.11.2023 13:00:36 Packaging Technology Berlin sgqwx page: U 1 Bayer AG client: GVDE material-no.: 90428726 PZ: 2780A-2 code-no.: Reference-Code: 500058R9 CMO-Code: DAW-00058-09 IFU date: 261023 name: LF-BRO BREELIB INHALER STARTER PACK country: GB/-/- colors: Black / CYAN /...
Page 2 90428726_02.indd 2 27.11.2023 13:00:36 Packaging Technology Berlin sgqwx page: U 2 Bayer AG client: GVDE material-no.: 90428726 PZ: 2780A-2 code-no.: Reference-Code: 500058R9 CMO-Code: DAW-00058-09 IFU date: 261023 name: LF-BRO BREELIB INHALER STARTER PACK country: GB/-/- colors: Black / CYAN / MAGENTA / YELLOW version: 27.11.2023/02...
Page 3 90428726_02.indd 3 27.11.2023 13:00:36 Packaging Technology Berlin sgqwx page: U 3 Bayer AG client: GVDE material-no.: 90428726 PZ: 2780A-2 code-no.: Reference-Code: 500058R9 CMO-Code: DAW-00058-09 IFU date: 261023 name: LF-BRO BREELIB INHALER STARTER PACK country: GB/-/- colors: Black / CYAN / MAGENTA / YELLOW version: 27.11.2023/02...
Page 4 Vectura Ireland Limited Block 2 Newtown Business and Enterprise Centre Newtownmountkennedy Co. Wicklow, A63 XV26 Ireland Vectura Group Ltd One Prospect West Chippenham, Wiltshire, SN14 6FH 0123 United Kingdom www.vectura.com DAW-00058-09 500058R9 261023 90428726 90428726_02.indd 4 27.11.2023 13:00:37 Packaging Technology Berlin sgqwx page: U 4 Bayer AG client: GVDE...
Page 5 DEFINITIONS User Assistance Information Definitions Please report any serious incident that has occurred in relation The following definitions are used throughout this document. to the device to the Manufacturer and the Regulatory Authority Please read these paragraphs carefully. of the country in which you reside. Warning To report a serious incident or for any questions relating to your Breelib™...
Page 6 CONTENT Content Content Safety Instructions 8.2.2. Cleaning Guidelines for the Nebuliser Unit and Terms Mouthpiece Intended Use 8.2.3. Rinse the Components Description 8.2.4. Clean the Components (Weekly) 4.1. Package Content 8.2.5. Disinfect the Components (Weekly) 8.2.6. Dry the Components 4.2. LEDs and Buttons 4.3.
Page 7 1. SAFETY INSTRUCTIONS 1. Safety Instructions RDo not open or disassemble the base unit. It may cause damage that is not covered by this warranty. Always have these instructions for use ready at hand. It is part RKeep the Breelib™ away from small children to prevent of Breelib™...
Page 8 2. TERMS Caution 2. Terms RSpecial precautions are needed for the Breelib™ regarding Used term Description EMC (electromagnetic compatibility). It needs to be used Breelib™ Inhalation system to nebulise the according to the EMC information provided in chapter VENTAVIS® inhalation solution “11.8. Electromagnetic Compatibility”...
Page 9 3. INTENDED USE 3. Intended Use 4. Description The Breelib™ Inhalation System is a breath Caution activated vibrating mesh nebuliser with passive flow and active If any of the components are missing, damaged or volume control. It is designed to be used for oral inhalation of incomplete, contact your Breelib™...
Page 10 4. DESCRIPTION Starter pack Nebuliser unit Drug dosing system Nebuliser body Carry case including base unit Charger Monthly pack D Mouthpiece 90428726_02.indd 6 27.11.2023 13:00:38 Packaging Technology Berlin sgqwx page: 6 Bayer AG client: GVDE material-no.: 90428726 PZ: 2780A-2 code-no.: Reference-Code: 500058R9 CMO-Code: DAW-00058-09 IFU date: 261023...
Page 11 4. DESCRIPTION Patients affected by colour-related vision impairment should seek the advice of their healthcare professional before using this product. Base 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 washing-up liquid (for manual dish washing, neutral pH between 6 and 8)
Page 12 4. DESCRIPTION C Reset button Blinking orange Device error: Breelib™ turns off. (refer to chapter To reset the hardware, refer to chapter "10.2. Resetting the "7.1. General Inhalation Guidelines" Hardware" on page 33. on page 16) D Auto-test LED All LEDs are Auto-test is in progress.
Page 13 5. BEFORE FIRST USE There will be no aerosol generation if the patient is not 5. Before First Use breathing through the Breelib™. Caution Caution RThe first use of the components must not be after the “1st Do not touch or clean the use before”...
Page 14 5. BEFORE FIRST USE RShade the power LED with your hands when in bright light RPlug the connector into the socket inlet of the base unit. conditions, so that you can clearly see whether the power LED pulses green or is brightly lit. RCharge the Breelib™...
Page 15 6. PREPARING FOR TREATMENT RDisconnect the charger from the mains. 6. Preparing for Treatment The Breelib™ is now ready for use. 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.
Page 16 6. PREPARING FOR TREATMENT 6.2. Assembling RThe mouthpiece must be latched into the base unit. 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 nebuliser unit immediately.
Page 17 6. PREPARING FOR TREATMENT 6.3. Fill the Nebuliser Unit with VENTAVIS® To fill the nebuliser unit with VENTAVIS®, you will need a single- use pipette. Follow these steps: Warning ROpen the glass ampoule. RUse a new ampoule of VENTAVIS® for each treatment. Always transfer the whole content of the ampoule into the dosing system.
Page 18 6. PREPARING FOR TREATMENT 6.4. Switch the Base Unit ON/OFF RDoser must be in horizontal position, not tilted for the If the Breelib™ is connected to the charger, disconnect it. Ensure filling step (see image 3). that the nebuliser unit is filled with VENTAVIS®. RTransfer all of the VENTAVIS®...
Page 19 6. PREPARING FOR TREATMENT To switch the base unit ON, follow these steps: RThe auto-test is finished when only the power LED is illuminated. The Breelib™ clicks twice at the end of the auto- RPress the ON/OFF button. test. RWait until the auto-test starts. Your Breelib™...
Page 20 7. TAKE A TREATMENT RHold the Breelib™ 7. Take a Treatment horizontally during A complete treatment session with the Breelib™ consists of: treatment. Holding the RThe inhalation system preparation, Breelib™ at an angle might impair performance. 15° tilt RThe inhalation itself, is permitted.
Page 21 7. TAKE A TREATMENT RTo see the mouthpiece LED clearly, avoid direct sunlight. Full brightness of the green mouthpiece LED indicates your RAvoid pressing the ON/OFF button accidentally. inhalation speed is correct. RBreathe in through your mouth and exhale through your mouth and nose.
Page 22 7. TAKE A TREATMENT Now you are prepared for your inhalation. Continue by inhaling. RInhale through the mouthpiece. The air channel opens and Refer to chapter “7.3. Inhaling”. you will hear a click. RContinue inhaling for 3 seconds. 7.3. Inhaling While inhaling, watch the mouthpiece LED to ensure correct To start the inhalation, follow these steps: inhalation speed.
Page 23 7. TAKE A TREATMENT than 5 minutes between breaths. In case the Breelib™ has blinking for 5 seconds). Be sure that your desired partner device switched off, press the ON/OFF button to continue the is in close range and has a wireless connection activated. The inhalation session.
Page 24 8. MAINTENANCE RRemove the mouthpiece from 8. Maintenance the base unit. After disassembling, continue 8.1. Disassembling with the cleaning procedure. For cleaning and storage purposes the components of the Refer to the chapter Breelib™ must be disassembled. “8.2. Cleaning and Warning Disinfection”.
Page 25 8. MAINTENANCE It is recommended to let the components air dry to ensure that they are adequately dried and ready for the next treatment. To avoid risks to health from a contaminated Breelib™, it is essential to comply with the following hygiene rules: Warning RDo not use any methods for cleaning or disinfection other than those described here.
Page 26 8. MAINTENANCE RThoroughly check the components of your Breelib™ Caution regularly and replace any defective components. RDo not use tap water. Any calcification can damage For details on how to clean, disinfect and dry the Breelib™, refer and reduce the lifetime of to corresponding chapters on the following pages.
Page 27 8. MAINTENANCE RRinse the drug dosing system with distilled water. Caution RDo 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 as it is damaged easily.
Page 28 8. MAINTENANCE RRinse the outside of the mouthpiece with distilled water. RTo air dry, put the mouthpiece and the nebuliser unit on a clean, dry and lint-free paper towel. Now you have rinsed the components. If necessary, continue with the weekly cleaning. Refer to chapter “8.2.4. Clean the Components (Weekly)”.
Page 29 8. MAINTENANCE RForbidden substances include: washing-up liquids with disinfectants, detergents with skin care additives, detergents for dish washers, acids, organic solvents, oxidizing agents. RUse washing-up liquid (for manual dish washing, neutral pH between 6 and 8). Caution RDo not use tap water. Any calcification can damage and reduce the lifetime of the nebuliser unit.
Page 30 8. MAINTENANCE ROpen and close the hinged cap twice while submerged to After you have cleaned the mouthpiece and the nebuliser unit clean the drug dosing system. of your Breelib™, disinfect them. Refer to chapter “8.2.5. Disinfect the Components (Weekly)”. RMake sure that the hinged cap is open. RLeave the components in the cleaning solution for at least 8.2.5.
Page 31 8. MAINTENANCE RPut the pan on the stove. RTurn on the heat. RBoil the distilled water with the nebuliser unit and the mouthpiece for 10 minutes. 10 min RTurn off the heat. Caution RDo not touch the hot components or boiling water. As this can lead to serious scalds.
Page 32 8. MAINTENANCE RLet the components cool down for 10 minutes. RPress the back end of the mouthpiece carefully on a The disinfection procedure is complete. After you have clean, dry and lint-free paper disinfected the components, continue with drying. towel to remove Please refer to chapter “8.2.6.
Page 33 8. MAINTENANCE 8.3. Storage and Transportation 8.3.1. Carry Case The Breelib™ must be rinsed or cleaned before storage (refer to If you transport the Breelib™, use the carry case provided. The chapter “8.2. Cleaning and Disinfection” on page 20). carry case has space for the nebuliser unit, the base unit and the mouthpiece.
Page 34 9. INITIAL PAIRING VIA WIRELESS CONNECTION 9. Initial Pairing via Wireless Connection 10. Troubleshooting RYou cannot take a treatment while your Breelib™ is 10.1. Error Messages connected to a partner device. Error Cause & Remedy To transfer data, you need a partner device which has the Prior to Start correct encryption protocol included to ensure cyber security.
Page 35 10. TROUBLESHOOTING Error Cause & Remedy Error Cause & Remedy RThe nebuliser unit is not The Breelib™ cannot be Very low battery power. filled correctly (refer to switched on. The mouthpiece RCharge the base unit before chapter “6.3. Fill the LED is blinking orange while taking a treatment (refer to Nebuliser Unit with ON/OFF button is pressed.
Page 36 10. TROUBLESHOOTING Error Cause & Remedy Error Cause & Remedy Charging REnsure that you do not block the air inlet at the Charging process does not Please follow charging back end of the base unit. start. instructions (refer to chapter “5.1. Charge Base Unit”...
Page 37 10. TROUBLESHOOTING Error Cause & Remedy Radio Frequency The Breelib™ does not react as There may be RF (radio expected. frequency) communication equipment around. Increase the distance from portable or mobile RF communication equipment. In case all of these actions are ineffective please reset the device (refer to chapter “10.2.
Page 38 11. TECHNICAL DATA 11. Technical Data Charger (Alternative) Manufacturer: UE Electronics Type: UES06WV 11.1. General UES06WNCP Breelib™ Model: UES06WV-050100SPA Filling Volume 1.0 ml UES06WNCP-050100SPA Inhalation Flow 15 l/min Power Input: 100 - 240 V / 50 – 60 Hz Weight 128 g Power Output: 5 VDC / 1000 mA...
Page 39 11. TECHNICAL DATA 11.4. Environmental Conditions for Use Ambient temperature during -10 to 35 °C The following table describes the ambient conditions required transport Humidity: 35-85% RH for the use of the Breelib™. Ambient temperature during -10 to 35 °C storage Humidity: 35-85% RH Ambient temperature...
Page 40 11. TECHNICAL DATA 11.7.1. Radio Equipment Directive 11.8. Electromagnetic Compatibility Vectura Group Ltd The Breelib complies with the electromagnetic compatibility One Prospect West standard, IEC 60601-1-2. The intended environment includes Chippenham, SN14 6FH home healthcare and professional healthcare facilities. The United Kingdom device is not intended to be used in military areas, near HF (High Frequency) surgical equipment and RF shielded rooms.
Page 41 11. TECHNICAL DATA Guidance and manufacturer’s declaration – electromagnetic Guidance and manufacturer’s declaration – electromagnetic emission immunity Emissions Test Compliance Electromagnetic Immunity IEC 60601- Compliance Electromagnetic Environment - Guidance test 1-2:2014 Level Environment - Test Guidance RF emissions Group 1 The Breelib™...
Page 42 11. TECHNICAL DATA Immunity IEC 60601- Compliance Electromagnetic Immunity IEC 60601- Compliance Electromagnetic test 1-2:2014 Level Environment - test 1-2:2014 Level Environment - Test Guidance Test Guidance Condition Condition Radio-frequency 3 V/m 3 V/m Mains power quality 28 V/m 28 V/m EM fields and 80 MHz –...
Page 43 11. TECHNICAL DATA Immunity IEC 60601- Compliance Electromagnetic Immunity IEC 60601- Compliance Electromagnetic test 1-2:2014 Level Environment - test 1-2:2014 Level Environment - Test Guidance Test Guidance Condition Condition Power frequency 30 A/m 30 A/m Power frequency Conducted RF 3 Vrms Portable and mobile (50/60 Hz) magnetic fields...
Page 44 11. TECHNICAL DATA Immunity IEC 60601- Compliance Electromagnetic Immunity IEC 60601- Compliance Electromagnetic test 1-2:2014 Level Environment - test 1-2:2014 Level Environment - Test Guidance Test Guidance Condition Condition V/m and d is the Fast transient/ ± 2 kV ± 2 kV Mains power quality recommended burst...
Page 45 11. TECHNICAL DATA Immunity IEC 60601- Compliance Electromagnetic Immunity IEC 60601- Compliance Electromagnetic test 1-2:2014 Level Environment - test 1-2:2014 Level Environment - Test Guidance Test Guidance Condition Condition Voltage dips, 0 % U for 0,5 Mains power quality Field strengths from fixed transmitters, such as base stations for radio short cycle should be that of a...
Page 46 11. TECHNICAL DATA 11.9. Recycling and Disposal Rated Separation distance according to frequency maximum of transmitter (m) This product falls within the scope of the European Council output of Directive on Waste Electrical and Electronic Equipment WEEE 150 kHz to 80 MHz to 800 MHz to transmitter...
Page 47 12. WARRANTY 12. Warranty 13. Explanation of Symbols During the warranty period, Vectura Group Ltd or the Breelib™ The following symbols may be used on the under side of the service partners will repair any defects resulting from faults in base unit and on the packaging.
Page 48 13. ExPLANATION OF SYMBOLS Humidity Limitations Battery status display This product is compliant with WEEE recycling ON/OFF button directives (Directive 2012/19/EU). Refer to chapter "11.9. Recycling and Disposal" on page 42 for further information. Direct current This device should be stored and used in dry conditions.
Page 49 13. ExPLANATION OF SYMBOLS Single patient multiple use Vectura Group Ltd reserve the right to make technical changes. 90428726_02.indd 45 27.11.2023 13:00:49 Packaging Technology Berlin sgqwx page: 45 Bayer AG client: GVDE material-no.: 90428726 PZ: 2780A-2 code-no.: Reference-Code: 500058R9 CMO-Code: DAW-00058-09 IFU date: 261023 name: LF-BRO BREELIB INHALER STARTER PACK country: GB/-/-...
Page 50 90428726_02.indd 46 27.11.2023 13:00:49 Packaging Technology Berlin sgqwx page: 46 Bayer AG client: GVDE material-no.: 90428726 PZ: 2780A-2 code-no.: Reference-Code: 500058R9 CMO-Code: DAW-00058-09 IFU date: 261023 name: LF-BRO BREELIB INHALER STARTER PACK country: GB/-/- colors: Black / CYAN / MAGENTA / YELLOW version: 27.11.2023/02 Restricted Document...
Page 51 90428726_02.indd 47 27.11.2023 13:00:49 Packaging Technology Berlin sgqwx page: 47 Bayer AG client: GVDE material-no.: 90428726 PZ: 2780A-2 code-no.: Reference-Code: 500058R9 CMO-Code: DAW-00058-09 IFU date: 261023 name: LF-BRO BREELIB INHALER STARTER PACK country: GB/-/- colors: Black / CYAN / MAGENTA / YELLOW version: 27.11.2023/02 Restricted Document...
Page 52 90428726 90428726_02.indd 48 27.11.2023 13:00:49 Packaging Technology Berlin sgqwx page: 48 Bayer AG client: GVDE material-no.: 90428726 PZ: 2780A-2 code-no.: Reference-Code: 500058R9 CMO-Code: DAW-00058-09 IFU date: 261023 name: LF-BRO BREELIB INHALER STARTER PACK country: GB/-/- colors: Black / CYAN / MAGENTA / YELLOW version: 27.11.2023/02...

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