ADVANCED BIONICS CI-5826 M Programming Cable User Manual

June 9, 2024
ADVANCED BIONICS

CI-5826 M Programming Cable
User ManualADVANCED BIONICS CI-5826 M Programming
Cable M PROGRAMMING CABLE
CI-5826

SYMBOLS TABLE

Labeling symbols and their meanings

| Date of Manufacture
---|---
| Manufacturer
| Model number
| LOT number
| Unique Device Identifier
| Type of Protection: BF
| Suitable temperature range for transport and storage
| See Instructions for Use
| Fragile
| Do not get wet
| Suitable relative humidity range for transport  and storage
****| Caution (refer to “Cautions & Warnings”section for further information)
| Dispose of in accordance with applicable national and local regulations
| MR Unsafe

Limitations and Contraindications

There are no known limitations or contraindications for the M Programming Cable.

Precautions, Cautions, and Warnings

  • The programming cable must be only be used by trained/qualified professionals.
  • Instruct patients to remove the headpiece if they encounter any overly loud sound or discomfort during fitting.
  • Do not attempt to service or modify the Naída CI M, Sky CI M, or its accessories. 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 the Naída CI M or Sky CI M system may include skin irritation and discomfort from pressure on the ear, device overheating, or overly loud sounds.

Product Description

The M Programming Cable is an interface between the Naída™ CI M or Sky CI™ M sound processor and the CPI-3 Clinical Programming Interface (CPI-3). It is only compatible with the Naída CI M and Sky CI M sound processors, the CPI-3, and Advanced Bionics Target CI.![ADVANCED BIONICS CI-5826 M Programming Cable

Intended Use

The M Programming Cable is intended to connect the Naída CI M or Sky CI M sound processor to the CPI-3 Clinical Programming Interface. This enables fitting of the Naída CI M or Sky CI M sound processor with Advanced Bionics Target CI.
The intended users of the M Programming Cable are cochlear implant professionals fitting the Naída CI M or Sky CI M Sound Processors. The intended use environments of the M Programming Cable are healthcare environments.

Compatibility

Naída CI M Programming Cable is compatible with Naída CI M and Sky CI M Sound Processors and the CPI-3 from Advanced Bionics.

Operating Instructions

Connecting the Programming Cable

  • Plug the micro-HDMI end of the programming cable into the CPI-3.
  • Slide the Naída CI M or Sky CI M sound processor onto the connector of the programming cable.
  • Verify that the sound processor appears in the Target CI fitting software.
  • To remove the sound processor, slide the Naída CI M or Sky CI M sound processor off of the connector of the programming cable.
Power SuPPly rated Voltage tyPe rated Power
M Programming Cable 5.0 V DC 1.25W

Care and Maintenance

Cleaning and Maintenance
The M Programming Cable should be kept free from dirt and dust. Clean and dry thoroughly after any exposure to dust, dirt, fluids, or high humidity. Clean the contacts as
needed using a dry cotton swab. Do not immerse the M Programming Cable in liquid.
Recommended Operating, Storage Temperature, and Humidity Ranges

Condition MiniMuM MaxiMuM
Operating Temperature 0˚C (32˚F) 45˚C (115˚F)
Storage Temperature -20˚C (-13˚F) 55˚C (131˚F)
Relative Humidity 0% 95%

Disposal and Hazardous Materials

Dispose of the M Programming Cable in accordance with  applicable national and local regulations. Hazardousmaterials: not applicable to this product.
Available Product Options and  Model Numbers

ProduCt oPtion Model nuMber
M Programming Cable CI-5826

**Clinical Benefits

**

The M Programming Cable provides no clinical benefit; this product is intended to be used with the Naída CI M and Sky CI M sound processors.
www.advancedbionics.com/clinicalandsafetyperformance/
Users of the M Programming Cable 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-Q809-A2 Rev A 2021-11-01
©2021 Advanced Bionics LLC. All Rights Reserved.

References

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