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Summary of Contents for Bruckhoff 48016
- Page 1 INSTRUCTIONS FOR USE BONE CONDUCTION HEARING SYSTEMS...
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Page 2: Table Of Contents
TABLE OF CONTENTS INSTRUCTIONS FOR USE PURPOSE Intended use and indication Contraindications and side-effects INFORMATION AND SAFETY INFORMATION General information How safety information is organised General safety information Key to symbols PRODUCT DESCRIPTION Variants and configurations Principle of operation Technical data Information about materials used Electromagnetic compatibility information OPERATION/USE - LA BELLE BC DELTA... -
Page 3: Instructions For Use
INSTRUCTIONS FOR USE These instructions for use apply to the following bone conduction hearing aids: • Spectacle hearing system – la belle BC D50 and la belle BC D70 • Headband hearing system (children’s hearing system) – la belle junior BC Delta 50 •... -
Page 4: Contraindications And Side-Effects
INSTRUCTIONS FOR USE BONE CONDUCTION HEARING AIDS Patients must not use the bone conduction hearing aid: 1.2 CONTRAINDICATIONS AND SIDE-EFFECTS • if the hearing loss is not covered by the adjustment range of the device; • if the hearing-impaired person suffers from skin irritation that is attributable to the materials used in the device;... - Page 5 • The bone conduction hearing aid will not restore normal hearing, nor will it prevent or CAUTION: correct loss of hearing from organic causes. • Keep the bone conduction hearing aid out of reach of small children, people with cognitive impairment (other than the patient) and pets.
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Page 6: Key To Symbols
INSTRUCTIONS FOR USE BONE CONDUCTION HEARING AIDS The following symbols are displayed on the device and packaging: 2.4 KEY TO SYMBOLS SYMBOL MEANING SYMBOL MEANING Manufacturer Temperature limit Article number Humidity limit Follow instructions for use Air pressure limit Serial number Protection class II device Medical device as per MDR Type B applied part... -
Page 7: Product Description
0123 BATTERY ARTICLE NUMBER CONFIGURATION TYPE (REF) la belle BC D50 listeners downstairs, left 48016 la belle BC D50 listeners downstairs, right 48017 la belle BC D50 listeners downstairs, left 48305 la belle BC D50 listeners downstairs, right 48307 la belle BC D50 listeners above, left... - Page 8 INSTRUCTIONS FOR USE BONE CONDUCTION HEARING AIDS Table 2: 2. Children’s hearing system version (headband hearing system) la belle Junior BC Delta 50, la belle BC Delta 70 0123 CONFIGURATION BATTERY TYPE ARTICLE NO. (REF) la belle junior BC Delta 50, left 48028 la belle junior BC Delta 50, right 48029...
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Page 9: Principle Of Operation
Table 3: 3. Headset hearing system version la belle headset BC D50, la belle headset BC D70 0123 ARTICLE NUMBER CONFIGURATION BATTERY TYPE (REF) la belle headset BC D50, left 48034 la belle headset BC D50, right 48035 la belle headset BC D50, left 48300 la belle headset BC D50, right 48301... -
Page 10: Technical Data
INSTRUCTIONS FOR USE BONE CONDUCTION HEARING AIDS 3.3 TECHNICAL DATA SPECTACLE HEARING SYSTEM HEADSET HEARING SYSTEM LA BELLE BC LA BELLE BC TECHNICAL DATA LA BELLE LA BELLE LA BELLE LA BELLE BC D50 BC D70 BC D50 BC D70 WDRC 16 channels 16 channels... - Page 11 CHILDREN’S HEARING SYSTEM (HEADBAND HEARING SYSTEM) LA BELLE TECHNICAL DATA LA BELLE LA BELLE BC D50 BC D70 WDRC 16 channels 16 channels Feedback canceller 4th generation 4th generation Noise reduction Wind noise reduction Volume control Channels Programmable frequency bands Programs Integrated sound generator Buttons...
- Page 12 INSTRUCTIONS FOR USE BONE CONDUCTION HEARING AIDS SPECTACLE HEARING SYSTEM HEADSET HEARING SYSTEM LA BELLE BC LA BELLE BC TECHNICAL DATA IN ACCORDANCE WITH EN 60601-2 LA BELLE LA BELLE LA BELLE LA BELLE BC D50 BC D70 BC D50 BC D70 Operating current (mA) Protection Protection...
- Page 13 CHILDREN’S HEARING SYSTEM (HEADBAND HEARING SYSTEM) LA BELLE TECHNICAL DATA IN ACCORDANCE WITH EN 60601-2 LA BELLE LA BELLE BC D50 BC D70 Operating current (mA) Electric shock protection type Protection class II Protection class II Electric shock protection for the applied part Type B Type B Mode of operation...
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Page 14: Information About Materials Used
INSTRUCTIONS FOR USE BONE CONDUCTION HEARING AIDS 3.4 INFORMATION ABOUT MATERIALS USED JUNIOR JUNIOR MATERIAL LA BELLE BC D50-70 HEADSET BC D50-70 BC D50 BC D70 Stainless steel 1.4404 (316L) X2CrNiMo17-12-2 Zirconium oxide ZrO2 Cellidor CAB-13A Black Lycra = 77% polyester and 23% elastane Headbands Jersey = 95% cotton and 5% elastane Electrical medical devices are subject to special precautions in terms of electromagnetic... -
Page 15: Operation/Use - La Belle Bc Delta
4 OPERATION/USE – LA BELLE BC DELTA Closing the battery compartment cover turns on the bone conduction hearing aid. 4.1 TURNING ON/OFF To turn off the bone conduction hearing aid, simply open the battery compartment cover. Battery compartment Battery compartment Device view cover closed cover open... -
Page 16: Changing The Battery
INSTRUCTIONS FOR USE BONE CONDUCTION HEARING AIDS Setting options on control element 2 • Bone conduction la belle junior BC You can change the settings for the following functions yourself: • Hearing program setting • Volume setting • Turning the device on/off Button for volume and program selection Childproof cover... - Page 17 1. Open the battery compartment cover. Same for all control elements: 2. Remove the battery with the included magnetic stylus. 3. Using the magnetic stylus, insert the new battery with the “+” symbol facing up. 4. Close the cover. 5. This automatically turns the hearing aid back on. Magnetic stylus Magnetic stylus Type 312...
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Page 18: Fitting And Wearing Instructions
INSTRUCTIONS FOR USE BONE CONDUCTION HEARING AIDS 4.4 FITTING AND WEARING INSTRUCTIONS Spectacle hearing system Insert the la belle hearing module (1) onto the temple arm of your glasses. You can use your la belle BC D50, la belle BC D70 glasses without the hearing aid by inserting the attachable glasses temple arm end piece (2). -
Page 19: Other Information
5 OTHER INFORMATION We recommended that you keep the bone conduction hearing aid in its original packaging 5.1 STORAGE until it is used for the first time. Once opened, always keep your bone conduction hearing aid in a safe, dry and clean place. Dead batteries may cause damage to the device. -
Page 20: Disposal
AUDIA AKUSTIK GMBH Franz-Mehring-Str. 13 99610 Sömmerda Germany Tel: +49 (3634) 693 - 0 Email: service@bruckhoff.com www.bruckhoff.com In accordance with the European Regulation on Medical Devices (2017/745), AUDIA AKUSTIK 5.6 MANUFACTURER’S OBLIGATIONS GMBH is obligated to inform you of the following: All serious incidents related to the product must be reported to AUDIA AKUSTIK GMBH and the competent authorities of the Member State in which the user and/or patient resides. -
Page 21: Your Notes
YOUR NOTES... - Page 22 INSTRUCTIONS FOR USE BONE CONDUCTION HEARING AIDS YOUR NOTES...
- Page 23 YOUR NOTES...
- Page 24 MANUFACTURING AND DISTRIBUTION: AUDIA AKUSTIK GMBH WWW.BRUCKHOFF.COM Franz-Mehring-Str. 13 | 99610 Sömmerda | Germany...
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