Naída CI M30 Sound Processor CI-5294 Advanced Bionics AG Laubisrütistrasse 28 8712 Stäfa, Switzerland +41 58 928 78 00 Manufactured by: Advanced Bionics LLC California, USA +1 661 362 1400 AdvancedBionics.
SYMBOLS TABLE: Labeling symbols and their meanings: Date of Manufacture Manufacturer Model number Serial number Unique Device Identifier Type of Protection: BF 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) Dispose of in accordance with applicable national and local regulations MR Unsafe IPXX Ingress Protection Rating
LIMITATIONS AND CONTRAINDICATIONS: There are no known limitations or contraindications for the Naída CI M30 sound processor. PRECAUTIONS, CAUTIONS, AND WARNINGS: This device should be used only by the individual for whom it is prescribed. CHOKING HAZARD: Contains small parts that pose a hazard of inhalation, choking, or ingestion. Using your sound processor and accessories contradictory to their intended use (e.g. mouthing, chewing) may cause bodily harm.
Remove your sound processor and consult your cochlear implant professional if uncomfortable sounds are heard or in case of discomfort, pain or skin irritation. If the sound processor or accessories become unusually hot or warm, discontinue use immediately and contact Advanced Bionics or your cochlear implant professional. 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.
determine speech performance and 2) able to report a preference for different coding strategies or features. 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 Naída CI or its accessories. Doing so may compromise system performance and will void the manufacturer’s warranty.
The intended users of the Naída CI M30 sound processor are recipients of Advanced Bionics cochlear implants. The intended use environments of the Naída CI M30 sound processor are healthcare and daily living environments.
OPERATING INSTRUCTIONS: Powering Naída CI M30 The sound processor is turned on when a charged battery is attached to the sound processor. When the battery is first attached, the orange LED located in the middle of the rocker switch will indicate battery charge. The startup program is selected by the cochlear implant professional during programming. To power down the Naída CI M30 sound processor, simply remove the battery. Attaching the Battery Hold the Naída CI M30 in one hand.
Align the battery connector with the sound processor housing side of the connector. FPO Image Slide the battery onto the sound processor until it clicks into place. Do not force the battery onto the sound processor. The batteries are designed to be inserted in only one direction; applying force may damage the equipment.
Removing the Battery Hold the Naída CI M30 in one hand. In the other hand, hold the battery. Rotate the headpiece cable upward in order to avoid bumping it upon battery removal. FPO Image Firmly slide the battery away from the M T-Mic or M Earhook.
Continue sliding the battery until it separates from the sound processor. FPO Image Approved Naída CI M30 Power Supplies Power Supply M Battery M Waterproof Battery M Zn-Air Battery Pak Nominal Voltage 3.6V – 3.7V 3.7V 2.3V Type Li-ion (rechargeable) Li-ion (rechargeable) Zn-air (disposable) Rated Capacity 0.3Wh – 0.8Wh 0.8Wh 1.4Wh Connecting the earhook to the sound processor There are two earhook options for the Naída CI M30 sound processor: the M T-Mic and the M Earhook.
Beginning with the earhook disconnected, align the earhook flush with the sound processor. Hold the earhook firmly at the top and push towards the sound processor until it meets flush with the sound processor. FPO Image Using the provided pin removal tool, place one of the pins in the small hole on the side of the tool. This will help to steady the pin as you line it up with the pin hole on the earhook.
Line up the pin with the hole in the earhook and gently push it through the hole. The pin will move from one side of the sound processor, through the earhook to the other side of the sound processor, holding the earhook in place. The pin should not come out the other side. FPO Image If a small portion of the pin extends beyond the sound processor, use the side of the tool to push the pin inwards so it lies flush with the sound processor.
Pull the tool away from the sound processor, leaving the pin inside the sound processor. FPO Image Removing the earhook Align the pointed end of the tool with the hole on the sound processor that contains the pin holding the earhook on the sound processor.
Gently press the tool in the hole, pushing the pin out the other side. FPO Image The pin does not need to be removed from the sound processor. As long as the tool is pushed in flush on one side of the sound processor, the pin should be displaced enough to adequately remove the earhook. Remove the tool from the sound processor. Gently grasp the earhook at the top near where it connects with the sound processor and pull forward until it is separated from the sound processor.
Attaching the headpiece cable to the sound processor To attach the headpiece cable to the sound processor, hold the headpiece cable by the cable’s strain relief. Align the connector on the cable with the connector on the sound processor and gently push the cable into the sound processor until it snaps into place. FPO Image Removing the Slim HP cable from the sound processor Remove the battery from the processor before removing the cable from the processor.
NOTE: To maximize cable life, the cable should only be unplugged from the sound processor when changing wearing configuration or when replacing the cable. Naída CI M30 LEDs The LED is a programmable feature that provides visual information about the Naída CI M sound processor status, battery life, program position, and sound processor error conditions.
Loss of Lock with the Implant Wrong Implant Red Red Error Condition (remove and reattach battery to reset sound processor) Detect Sound Processor Red Green audio. Slow blinking (once per second) Fast blinking (more than once per second) Solid Red 3 blinks upon command from mobile application or fitting software Yes No No No Naída CI M30 Internal Alarms The internal alarms are programmable and provide auditory information about the Naída CI M30 sound processor.
or phone call volume up or down (during call) or end phone call (during call) Connectivity Overview The Naída CI M30 sound processor can be connected to Bluetooth-enabled devices for phone calls, VoIP calls, audio streaming, or for use with the AB Remote mobile application. Pairing and Connecting the Naída CI M30 to a Bluetooth-Enabled Device 1. Ensure that Bluetooth wireless technology is enabled on your device (e.g.
Managing Bluetooth Phone Calls with the Naída CI M30 When the sound processor is directly connected with a Bluetooth-enabled phone, you will be able to hear the caller’s voice directly through the sound processor. The sound processor picks up your voice through the sound processor microphones. FPO Image When making a phone call, you will hear a dialing tone through the sound processor. The sound processor microphones pick up your voice.
You can reject or end a call with a long press on the upper or lower part of the multifunction button on the sound processor or directly through the phone. FPO Image Streaming Audio via Bluetooth with the Naída CI M30 After successful pairing of your processor(s) to your Bluetooth-enabled device, ensure that your device is not muted and volume is not set to minimum. Then, simply start the audio on the Bluetooth-enabled device and the sound processor will start streaming the audio.
mode will not disable normal sound processor functionality but will disable Bluetooth connectivity functions. Activating and Deactivating Flight Mode 1. Hold down either the top or bottom of the multifunction button while attaching the battery. 2. Continue to hold down the button while the sound processor starts up, until a long, solid orange LED is visible, approximately 10 seconds.
The following product configurations have an IP rating of 54 (protection against dust; protection against failure due to water splashes from all directions): The Naída CI M30 sound processor with an M Battery or M Zn-Air Battery Pak, an M T-Mic and a Slim HP or Slim HP Mic. The Naída CI M30 sound processor with an M Zn-Air Battery Pak, an M Earhook, and a Slim HP or Slim HP Mic.
Sentences in Quiet at 65 dBA Across all subjects, similar sentence recognition scores in quiet were observed between AutoSense OS and the AutoSense OS Off program. See the table below. N Mean (SD) Median Min, Max 2 List AutoSense OS Average Score (%) 10 88.92 (11.068) 94.65 63.2, 96.7 2 List AutoSense OS Off Average Score (%) 10 89.76 (11.677) 92.88 61.2, 99.
noisy environments, although one of these subjects agreed that sound quality was acceptable and listening was comfortable in noise. These questionnaire results indicate that the sound processor is acceptable for use and satisfies users’ listening needs.
GUIDELINES FOR IT SECURITY: Intended Use Environment The Naída CI M30 sound processor system is intended for use in healthcare and home environments. The home environment is extended to include use outdoors and during travel (e.g., airplanes). The Naída CI M30 sound processor system is intended to operate with the AB Remote application, the Phonak RemoteControl, the Target CI fitting software, and with any Bluetooth-enabled device used for audio streaming.
Sound Processor Remote Control RF Bidirectional Bluetooth Bidirectional Roger Devices Roger DM Bidirectional v1.6 (SPP v1.2, RFCOMM v1.2 over L2CAP) Bluetooth Classic: Advanced Audio Distribution Profile v1.3 (AVDTP v1.3 over L2CAP) Bluetooth Classic: Audio/Video Remote Control Profile v1.5 (AVCTP v1.
Advanced Bionics does not patch the Naída CI M30 sound processor. Firmware updates may be made available from time to time and will require visiting your cochlear implant professional to reimage your sound processor. Authenticity of firmware can be verified by your cochlear implant professional using the Target CI fitting software. Available Training Users of the Naída CI M30 sound processor are trained by their cochlear implant professional at the initial fitting session.
Electrostatic discharge (ESD) IEC 61000-4-2 ± 6 kV contact ± 8 kV air ± 6 kV contact ± 8 kV air Power frequency (50/60 3 A/m Hz) Magnetic Field IEC 61000-4-8 3 A/m Radiated RF IEC 61000-4-3 3 V/m 3 V/m 80 MHz to 2.5 GHz 3 Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. As with the operation of other electronic devices, precaution should be taken to not generate ESD.
survey,b should be less than the compliance level in each frequency range.c Interference may occur in the vicinity of equipment marked with the following symbol: Note 1: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. a. Essential performance of the Naída CI per IEC 60601 requirements is defined as auditory stimulation within safe amplitudes. b.
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note 1: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
Cet appareil est conforme à la partie 15 des règlements de la FCC et à la norme RSS-210 d’Industrie Canada. Son fonctionnement est soumis aux deux conditions suivantes : 1. cet appareil ne doit pas provoquer d’interférences nuisibles, et 2. cet appareil doit accepter les interférences reçues, y compris les interférences pouvant entraîner un fonctionnement indésirable.
