BIONICS CI-7524 Advanced Bionics Cochlear Implant Instructions

BIONICS CI-7524 Advanced Bionics Cochlear Implant

SYMBOLS TABLE

Labeling symbols and their meanings

• Date of Manufacture
• Manufacturer
• Model number
• LOT number
• Unique Device Identifier
• Suitable temperature range for transport and storage
• See Instructions for Use
• Fragile
• Suitable relative humidity range for transport and storage
• Caution (refer to “Cautions & Warnings” section for further information)
• MR Unsafe

Limitations and Contraindications
There are no known limitations or contraindications for the Slim HP Magnets.

Precautions, Cautions, and Warnings

• This device should be used only by the individual for whom it is prescribed.
• CHOKING H AZARD: Contains small parts that pose a hazard of inhalation, choking, or ingestion. If any parts are swallowed or inhaled, consult a physician or hospital immediately.
• Do not leave children unattended with or allow children to play with the Slim HP or Slim HP Magnets.
• Do not allow children to place the Slim HP or Slim HP Magnets in the mouth or nose.
• The large Slim HP Color Cap is for use by recipients older than 3 years of age, as this color cap and the Slim HP magnet may become displaced upon dropping.
• Use the lowest strength magnet required to ensure sufficient magnetic attraction of the headpiece.
• If the magnetic attraction of the headpiece is insufficient, the user should contact their cochlear implant professional.
• If the headpiece magnet is too strong, pressure sores may develop at the headpiece site. If this happens, or if you experience any discomfort, irritation, pressure, or redness in this area, contact your cochlear implant professional.
• The magnetic field created by the headpiece magnet may alter the programming of magnetic shunts. Users of magnetic shunts should consider off-the-shelf retention methods.
• Store spare magnets safely and away from cards that may have a magnetic strip (e.g. credit cards) and from other spare magnets or headpieces.
• In the event that you experience any issues with your product, please contact your cochlear implant professional or the manufacturer. Do not attempt to service or modify the Slim HP. Doing so may compromise system performance and will void the manufacturer’s warranty. Products should be serviced only at Advanced Bionics and damaged products should be returned to Advanced Bionics.

Undesirable Side Effects

Undesirable side effects of your Slim HP Magnet may include skin irritation and discomfort from pressure on the ear or head.

Product Description

The Slim HP Magnet is a removable magnet that is available in two different types.

• Standard Magnets
  • Black in color
  • Compatible with CII, HiRes 90k, HiRes 90k Advantage, and HiRes Ultra implants
• 3D Magnets
  • Blue in color
  • Compatible with HiRes Ultra 3D implants
  • 3D marking on top of magnet with arrow to help orient the magnet in the general upward direction within the headpiece

Each magnet type is available in seven different strengths to ensure retention between the cochlear implant and the headpiece. The strength is marked on the bottom of the magnet, with 1 being the weakest magnet and 7 being the strongest magnet

The Slim HP Color Cap snaps in place on top of the headpiece securely covering the magnet well and the microphone. There are two sizes of Slim HP Color Caps: Standard and Large.

• The Standard Color Cap is for use with the smallest Slim HP Magnets: Standard Magnet sizes 1 through 5 and 3D Magnet sizes 1 through 4.
• The Large Color Cap is for use with the largest Slim HP Magnets: Standard Magnet sizes 6 and 7 and 3D Magnet sizes 5, 6, and 7.

If there is a plus sign following the magnet strength on the bottom of the magnet, the Large Color Cap should be used.

The Slim HP Color Cap Removal Tool aids in the removal of the Slim HP Color Cap from the headpiece.

Intended Use

The Slim HP Magnets are intended to be used with the Slim HP, Slim HP Mic, Slim HP AquaMic™ microphone, and Slim HP Standard. The Slim HP Magnets are intended to secure the headpiece to the user’s head. The intended users of the Slim HP magnets are users of the Slim HP products. The intended use environments of the Slim HP magnets are healthcare and daily living environments.

Compatibility
The Slim HP Magnets are compatible with the Slim HP, Slim HP Mic, Slim HP AquaMic, and Slim HP Standard

Operating Instructions

Magnets
It is important for the headpiece to have the correct magnet strength and orientation to avoid discomfort or retention issues. If deemed appropriate, the headpiece magnet may be adjusted with a stronger or weaker magnet, or different magnet orientation. If needed, off-the-shelf solutions may be used to improve retention.

Magnet Strength
The seven different strengths of the Slim HP Magnets offer different retention strength options.

Adjusting Magnet Strength
Remove the Slim HP Color Cap using the Slim HP Color Cap Removal Tool

Remove the magnet from the magnet well by pushing the magnet up from the underside of the Slim HP.

Replace the magnet as needed using the minimum magnet strength required to maintain retention. When inserting the magnet, align the triangle on the side of the magnet with a notch in the magnet well of the Slim HP. For Slim HP 3D Magnets, orient the arrow on the magnet in a general upward direction when inserting the magnet.

Press the magnet down so that the underside of the magnet is flush with the underside of the Slim HP.

Attach the Slim HP Color Cap by aligning it over the Slim HP and snapping it into place

Note for Recipients of HiRes Ultra 3D implants:

• If you experience retention issues, it may be because the arrow on the magnet is not oriented in the recommended direction.
• If the headpiece repels or pushes away when brought over the internal device, rotate the headpiece back and forth as you move the headpiece closer towards the implant. Once attraction is felt, adjust the headpiece to the original orientation and place on head.
• When in a magnetic field or when the headpiece is removed, you may feel the internal components of the magnet vibrate and/or rotate. This movement is expected as the magnets are designed to rotate in the presence of strong magnetic fields. This movement may be noticeable and is not expected to be uncomfortable.

CARE AND MAINTENANCE

Storing the Slim HP Magnets
Store spare magnets safely and away from cards that may have a magnetic strip (e.g. credit cards) and from other spare magnets or headpieces.

Cleaning and Maintenance
Use a soft cloth to clean magnets. Do not use solvents.

Recommended Operating and Storage Temperature Ranges

DISPOSAL AND HAZARDOUS MATERIALS:
Dispose of the Slim HP Magnets in accordance with applicable national and local regulations. Hazardous materials: not applicable to this product.

AVAILABLE PRODUCT OPTIONS AND MODEL NUMBERS

P roduCt o Ption| M o d e l n uMber| P roduCt o Ption| M o d e l n uMber
---|---|---|---
Standard Magnet 1| CI-7524-001| 3D Magnet 1| CI-7525-001
Standard Magnet 2| CI-7524-002| 3D Magnet 2| CI-7525-002
Standard Magnet 3| CI-7524-003| 3D Magnet 3| CI-7525-003
Standard Magnet 4| CI-7524-004| 3D Magnet 4| CI-7525-004
Standard Magnet 5| CI-7524-005| 3D Magnet 5| CI-7525-005
Standard Magnet 6| CI-7524-006| 3D Magnet 6| CI-7525-006
Standard Magnet 7| CI-7524-007| 3D Magnet 7| CI-7525-007

CLINICAL BENEFITS:
The Slim HPs provide no clinical benefit; these products are intended to be used with the Neptune, Naída™ CI Q, Naída™ CI M, and Sky CI™ M sound processors.

www.advancedbionics.com/clinicalandsafetyperformance/

Users of the Slim HPs in the European Union should report any serious incident to their local competent authority.

Advanced Bionics LLC 28515 Westinghouse Place Valencia, CA 91355, USA

• Tel : +1 661-362-1400
• AdvancedBionics.com

029-Q808-A2 Rev A 2021-11-01 ©2021 Advanced Bionics LLC. All Rights Reserved.

References

• Advanced Bionics

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