Bayer HealthCare Breelib Instructions For Use Manual
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Bayer HealthCare Breelib Instructions For Use Manual

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

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Summary of Contents for Bayer HealthCare Breelib

  • Page 1 Packaging Technology Berlin SGQWX page: U 1 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...
  • Page 2 Packaging Technology Berlin SGQWX page: U 2 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...
  • Page 3 Packaging Technology Berlin SGQWX page: U 3 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...
  • Page 4 Packaging Technology Berlin SGQWX page: U 4 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...
  • Page 5 DEFINITIONS User Assistance Information Definitions For any questions relating to your Breelib™ Inhalation System The following definitions are used throughout this document. please refer to the Contact Details on the back cover of this Please read these paragraphs carefully. Instructions for Use.

  • Page 6: Table Of Contents

    Packaging Technology Berlin SGQWX page: 2 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: Safety Instructions

    Always have these instructions for use ready at hand. It is part RDo not use the Breelib™ if it is damaged or modified. Only of Breelib™ Inhalation System and a requirement for the use accessories supplied by an service partner.

  • Page 8: Terms

    Inhalation system to nebulise the according to the EMC information provided in chapter VENTAVIS® inhalation solution “11.9. Electromagnetic Compatibility” on page 37. Pulmonary arterial hypertension RThe Breelib™ may be affected by portable or mobile RF VENTAVIS® Inhalation solution (radio frequency) communication equipment like mobile Base unit Component containing the hardware phones or computer equipment.

  • Page 9: Intended Use

    Guidelines for Reuse RCharger RMonthly pack (nebuliser unit + mouthpiece) 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.
  • Page 10 Packaging Technology Berlin SGQWX page: 6 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: Leds And Buttons

    RUse standard washing-up liquid (for manual dish washing, A ON/OFF button neutral pH between 6 and 8) For more details on switching the Breelib™ ON and OFF, refer RClean, dry and lint-free paper towels for drying to chapter "6.4. Switch the Base Unit ON/OFF" on page 14.

  • Page 12: Inhalation System

    Breelib™ pauses for 1 second between each inhalation. If you F Mouthpiece LED pause for more than 5 minutes, the Breelib™ turns off. If you Constant green Inhalation mode (refer to chapter have successfully completed a treatment, the mouthpiece LED "7.1.

  • Page 13: Before First Use

    RIf the “1st use before” date marked on the outer packaging under side of the nebuliser unit has passed, contact your Breelib™ service partner. with abrasive materials. Avoid touching the membrane during RUnpack all components of the starter pack.
  • Page 14 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...

  • Page 15: Preparing For Treatment

    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™.

  • Page 16: 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 it immediately.

  • Page 17: Fill The Nebuliser Unit With Ventavis

    VENTAVIS®. 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). 86886863_01.indd 13 3/28/2019 11:16:39 AM...

  • Page 18: Switch The Base Unit On/Off

    Switch the Base Unit ON/OFF RTransfer all of the VENTAVIS® with the pipette into the If the Breelib™ is connected to the charger, disconnect it. Ensure centre of the drug dosing that the nebuliser unit is filled with VENTAVIS®. system.
  • Page 19 RPress the ON/OFF button. test. RWait until the auto-test starts. Your Breelib™ is switched ON. You can now take a treatment. To All LEDs and the mouthpiece are illuminated during the continue, read the following chapter “7. Take a Treatment” on auto-test.

  • Page 20: Take A Treatment

    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: Inhalation Feedback

    Packaging Technology Berlin SGQWX page: 17 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 22: Inhaling

    Packaging Technology Berlin SGQWX page: 18 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 23: Automatic Wireless Connection After Each Treatment

    This ensures full functionality for Connection” on page 29. the next treatment. In order to clean the Breelib™, you will need to disassemble it. For more details on how to disassemble, continue with chapter “8.1. Disassembling” on page 20.

  • Page 24: Maintenance

    RDo not disassemble the nebuliser unit. RRinsing after each use Disassembling could affect the dosing accuracy. RCleaning a minimum of once a week To disassemble the components of the Breelib™, follow these RDisinfection once a week steps: Cleaning procedure RRemove the...
  • Page 25 ROnly use a mouthpiece and nebuliser unit which has been cleaned according to the procedures described in this chapter. RIf the Breelib™ has not been used for a couple of days, both the nebuliser unit and mouthpiece must be cleaned and disinfected prior to use.
  • Page 26 Packaging Technology Berlin SGQWX page: 22 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 27 Packaging Technology Berlin SGQWX page: 23 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 28: Reference-Code: 08Cn0109

    (refer to chapter distilled water only. “8.3. Storage and Transportation” on page 28. 8.2.3. Clean the Components (Weekly) The components of the Breelib™ must be cleaned at least once a week. Warning RDo not use a washing-up liquid with skin care additives (for To clean the base unit, wipe the housing with a damp cloth or a example balsam) or disinfectant properties.
  • Page 29 Packaging Technology Berlin SGQWX page: 25 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 30 8. MAINTENANCE After you have cleaned the mouthpiece and the nebuliser unit of your Breelib™, disinfect them. Refer to chapter “8.2.4. Disinfect the Components (Weekly)”. 8.2.4. Disinfect the Components (Weekly) Caution RClean the nebuliser unit and the mouthpiece prior to disinfection (refer to chapter “8.2.3. Clean the Components (Weekly)”...
  • Page 31 Packaging Technology Berlin SGQWX page: 27 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 32: Storage And Transportation

    RLet the components dry adequately overnight, if possible. Your Breelib™ is now ready for the next treatment or for storage and transportation. For more details on how to store or transport the Breelib™, read chapter “8.3. Storage and Transportation”.

  • Page 33: Initial Pairing Via Wireless Connection

    9. INITIAL PAIRING VIA WIRELESS CONNECTION 8.3.1. Carry Case 9. Initial Pairing via Wireless Connection If you transport the Breelib™, use the carry case provided. The Caution carry case has space for the nebuliser unit, the base unit and RYou cannot take a treatment while your Breelib™ is the mouthpiece.

  • Page 34: Troubleshooting

    Packaging Technology Berlin SGQWX page: 30 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 35 Packaging Technology Berlin SGQWX page: 31 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 36 Packaging Technology Berlin SGQWX page: 32 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 37: Resetting The Hardware

    (refer to chapter 10.2.) and contact your service partner if necessary. If you follow these instructions and the error still persists, contact your Breelib™ service partner for assistance or prescribing physician for assistance. RRelease the buttons. 10.2. Resetting the hardware The reset is completed when you see short green flashes from the mouthpiece LED.

  • Page 38: Technical Data

    Packaging Technology Berlin SGQWX page: 34 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 39: Aerosol Characteristics

    The following graph shows the particle size distribution curve. The cumulative mass [%] is displayed against the upper The particle size and output rate of the Breelib™ were measured aerodynamic diameter [µm]. according to the test methods described in EN 13544:2007 Respiratory therapy equipment –...

  • Page 40: Service Life

    11. TEChNICAL DATA 11.4. Service Life Ambient temperature during -10 to 35 °C The Breelib™ is intended for repeated use. The service life of the transport Humidity: 35-85% RH components is given in the following table: Ambient temperature during -10 to 35 °C...

  • Page 41: Electromagnetic Compatibility

    11. TEChNICAL DATA 11.8.1. Radio Equipment Directive RThe Breelib™ should not be used near to other equipment. If Vectura Group plc this is necessary, the Breelib™ should be checked to verify One Prospect West normal operation in the configuration in which it will be Chippenham, SN14 6FH used.
  • Page 42 Packaging Technology Berlin SGQWX page: 38 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 43 Packaging Technology Berlin SGQWX page: 39 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 44 Packaging Technology Berlin SGQWX page: 40 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 45 RF disturbances are controlled. NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. The customer or the user of the Breelib™ can help prevent NOTE 2 These guidelines may not apply in all situations. Electromagnetic is electromagnetic interference by maintaining a minimum affected by absorption and reflection from structures, objects and people.

  • Page 46: Recycling And Disposal

    Packaging Technology Berlin SGQWX page: 42 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 47: Warranty

    Compensation for direct or indirect damage or injury is excluded from the warranty. If you have a complaint, contact your Breelib™ service partner or send the device to Vectura Group plc in its original packaging. Consumables are excluded from the warranty.
  • Page 48 Packaging Technology Berlin SGQWX page: 44 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...

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