ADVANCED BIONICS CI-5826 M Programming Cable User Manual

	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.

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.