Summary of Contents for Advanced Bionics Naída CI M90
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Naída CI M90 Sound Processor CI-5293 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.com 029-M796-A2 Rev A 2020-03-02...
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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 &...
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Do not use any other power supply with the sound processor or accessories unless it is supplied by Advanced Bionics. If needed, please call Advanced Bionics for a power supply replacement. Do not use accessories when they are plugged into power sources such as wall outlets, or other power sources that are USB compatible (e.g.
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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.
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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. Products should be serviced only at Advanced Bionics and damaged products should be returned to Advanced Bionics.
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The intended users of the Naída CI M90 sound processor are recipients of Advanced Bionics cochlear implants. The intended use environments of the Naída CI M90 sound processor are healthcare and daily living environments.
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thus, it is the user's responsibility to do product compatibility testing by himself before making purchasing decisions on smartphones and other Bluetooth-enabled devices. OPERATING INSTRUCTIONS: Powering Naída CI M90 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.
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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.
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Removing the Battery Hold the Naída CI M90 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, M Earhook, or M Acoustic Earhook. FPO Image...
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Continue sliding the battery until it separates from the sound processor. FPO Image Approved Naída CI M90 Power Supplies Power Supply Nominal Voltage Type Rated Capacity M Battery 3.6V – 3.7V Li-ion (rechargeable) 0.3Wh – 0.8Wh M Waterproof Battery 3.7V Li-ion (rechargeable) 0.8Wh M Zn-Air Battery Pak...
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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.
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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.
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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.
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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.
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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.
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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 M90 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.
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audio. Loss of Lock with the Implant Slow blinking (once per second) Wrong Implant Fast blinking (more than once per second) Error Condition (remove and Solid Red reattach battery to reset sound processor) Detect Sound Processor Green 3 blinks upon command from mobile application or fitting software Naída CI M90 Internal Alarms...
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or phone call volume up or down or end phone call (during call) (during call) Connectivity Overview The Naída CI M90 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 M90 to a Bluetooth-Enabled Device 1.
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Managing Bluetooth Phone Calls with the Naída CI M90 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.
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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 M90 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.
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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.
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CI-5293-240 CLINICAL BENEFITS: Advanced Bionics has completed a confirmatory study of AutoSense OS on the Naída CI M90 sound processor. A total of 10 subjects were enrolled in a prospective study using a within-subjects repeated- measures design where each subject served as his/her own control. Five subjects used the M Acoustic Earhook, while the remaining 5 used the M T-mic and electrical stimulation only.
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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. 2 List AutoSense OS 2 List AutoSense OS Off Average Score (%) Average Score (%) Mean (SD) 88.92 (11.068)
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2) are able to report a preference for different coding strategies or features. ClearVoice is only available in markets where ClearVoice has received regulatory approval. Contact Advanced Bionics for more information. COUNSELLING AND FITTING RECOMMENDATIONS: ...
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AutoSense OS: The intent of the AutoSense program is to classify the listening environment and activate sound processing features based on the listening environment. The AutoSense program is enabled by default as the start-up program. Cautions UltraZoom and StereoZoom are beamforming algorithms; therefore, by design they focus to the front and dampen sound from the side and back of the recipient.
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System and Network Diagram System Interfaces Component Interface Data Transfer Communication Protocol Security Direction Sound Bluetooth Bidirectional Bluetooth Classic: Hands- Bluetooth Classic: Processor Free Profile with E0 encryption wideband speech option Bluetooth LE: AES- v1.6 (SPP v1.2, RFCOMM CCM 128 v1.2 over L2CAP) encryption...
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Advanced Bionics cochlear implant when fit with the Target CI fitting software. All events are logged to an internal event log. Advanced Bionics can interpret and analyze the log if the device is returned. Data integrity and quality of service is ensured through sound processor and implant error correction and detection mechanisms.
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Advanced Bionics does not patch the Naída CI M90 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.
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the relative humidity should be at least 30%. As with the operation of other electronic devices, precaution should be taken to not generate ESD. Power frequency (50/60 3 A/m 3 A/m Power frequency Hz) Magnetic Field magnetic fields should IEC 61000-4-8 be at levels characteristic of a typical location in a...
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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.
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2. This device must accept any interference received, including interference that may cause undesired operation. Changes or modifications made to this equipment not expressly approved by Advanced Bionics may void the FCC authorization to operate this equipment. This Class B digital apparatus complies with Canadian ICES-003.