1. Manuals
  2. Brands
  3. Advanced Bionics Manuals
  4. Recording Equipment
  5. CI-5293
  6. Instructions for use manual

Advanced Bionics CI-5293 Instructions For Use Manual

Hide thumbs
Table of Contents

Advertisement

Quick Links

Download this manual
Naída
CI M90 Sound Processor
™
CI-5293
instructions for use

Advertisement

Table of Contents
loading

Related Manuals for Advanced Bionics CI-5293

Summary of Contents for Advanced Bionics CI-5293

  • Page 1 Naída CI M90 Sound Processor ™ CI-5293 instructions for use...

  • Page 3: Symbols Table

    SYMBOLS TABLE Labeling symbols and their meanings Date of Manufacture XXXX-XX-XX Manufacturer Model number Serial number Unique Device Identifier Type of Protection: BF Suitable temperature range for transport and storage...
  • Page 4 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...
  • Page 5 While no injury cases have resulted, components may become hot during normal use or a fault condition. If the device’s temperature results in discomfort or pain when touched, disconnect the power source and contact your local Advanced Bionics representative.
  • Page 6 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 •...
  • Page 7 (either with the multifunction button or with the mobile application) may compromise situational awareness. • Do not use your Advanced Bionics accessories when instructed not to use wireless electronic devices, such as on airplanes. • Remove your sound processor and headpiece before entering a room where an MRI scanner is located and prior to having any surgeries that involve electrocautery and diathermy.
  • Page 8 • 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.
  • Page 9 It should be noted, however, that when operating the device near a computer terminal or other strong electromagnetic field (e.g., RFID system, metal detectors, electromagnetic anti-theft systems), it may be necessary to be at least 24” (60 cm) away to ensure proper operation. If the Naída CI M90 sound processor does not respond to the implant device because of an unusual field disturbance, move away from the disturbing field.
  • Page 10 result (e.g., poor sound quality, cutouts in sound, delay in response when making adjustments, or loss of lock). • The Naída CI M90 sound processors and accessories should be used in accordance with the electromagnetic compatibility information provided in the Guidance and Manufacturer’s Declaration section of this document.
  • Page 11 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.
  • Page 12 Product Description and Performance Characteristics The Naída CI M90 Sound Processor is a behind-the-ear (BTE) sound processor for use with an Advanced Bionics cochlear implant. The Naída CI M90 is comprised of the components pictured below. Light Emitting Diode...

  • Page 13: Intended Use

    The Naída CI M90 sound processor features direct connectivity to wireless accessories and Bluetooth technology enabled devices. The Naída CI M90 offers ® multiple power options and wearing options for the user. The system is designed to provide useful hearing to individuals with severe-to-profound hearing loss.
  • Page 14 HiRes™ 90K Advantage • HiRes™ Ultra • HiRes™ Ultra 3D The Naída CI M90 is compatible with the following Advanced Bionics products: • M Batteries, M Zn-Air Battery Pak, M Waterproof Battery • M T-Mic™ microphone, M Earhook, M Acoustic Earhook •...
  • Page 15 The Naída CI M90 is compatible with the following programming interfaces: • Advanced Bionics Clinical Programming Interface CPI-3 with the M Programming Cable • NoahLink Wireless programmer The Naída CI M90 is compatible with the following accessory products: • AB Remote mobile application •...
  • Page 16 Advanced Bionics assumes no responsibility for the compatibility; 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.

  • Page 17: Attaching The Battery

    Attaching the Battery Hold the Naída CI M90 in one hand. Rotate the headpiece cable upward in order to avoid bumping it upon battery placement. Align the battery connector with the sound processor housing side of the connector.
  • Page 18 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.

  • Page 19: Removing The Battery

    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. Firmly slide the battery away from the M T-Mic, M Earhook, or M Acoustic Earhook.
  • Page 20 Continue sliding the battery until it separates from the sound processor. Approved Naída CI M90 Power Supplies ower uPPly omiNal ated aPaCity oltage 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 2.3V Zn-air (disposable)
  • Page 21 Connecting the earhook to the sound processor There are three earhook options for the Naída CI M90 sound processor: the M T-Mic, the M Earhook, and the M Acoustic Earhook. Beginning with the earhook disconnected, align the earhook flush with the sound processor.
  • Page 22 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.
  • Page 23 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.
  • Page 24 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.
  • Page 25 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.
  • Page 26 Removing the Slim HP cable from the sound processor Remove the battery from the processor before removing the cable from the processor. To remove the cable from the sound processor, always hold the cable’s strain relief and gently pull it away.
  • Page 27 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.
  • Page 28 Low Battery NdiCatioN Orange olor Continuous Blinking ehaVior rogrammaBle Current Program NdiCatioN Green olor Blinks at start-up after battery status and upon program change ehaVior • 1 long blink is AutoSense program • 1 short blink is program 1 • 2 short blinks is program 2 •...
  • Page 29 Progressive Level Change NdiCatioN Purple olor 1 blink upon changing ehaVior rogrammaBle Loud Input NdiCatioN Green olor Blinks during use in response to loud input sounds. Indicates the sound ehaVior processor and microphone are responding to sound. rogrammaBle Streaming Input NdiCatioN Blue olor...
  • Page 30 rogrammaBle Wrong Implant NdiCatioN olor Fast blinking (more than once per second) ehaVior rogrammaBle Error Condition (remove and reattach battery to reset sound processor) NdiCatioN olor Solid Red ehaVior rogrammaBle Detect Sound Processor NdiCatioN Green olor 3 blinks upon command from mobile application ehaVior rogrammaBle...
  • Page 31 Naída CI M90 Internal Alarms The internal alarms are programmable and provide auditory information about the Naída CI M90 sound processor. Your cochlear implant professional can adjust the volume and pitch of the internal alarms to suit your preference. NdiCatioN ehaVior rogrammaBle Low Battery 2 beeps...

  • Page 32: Connectivity Overview

    Using the Naída CI M90 Multifunction Button The multifunction button has several functions which can be programmed by the hearing care professional. The button can function as a volume control and/or a program change depending on the programming. Please ask your cochlear implant professional to confirm how your sound processor is programmed.
  • Page 33 Pairing and Connecting the Naída CI M90 to a Bluetooth-Enabled Device 1. Ensure that Bluetooth wireless technology is enabled on your device (e.g., phone, tablet) and search for Bluetooth-enabled devices in the connectivity settings menu. 2. Power on the Naída CI M90 sound processor by connecting the sound processor to a power source.
  • Page 34 NOTE: Once a sound processor has been paired to a device it is recommended to keep paired devices in silent mode to avoid dropouts related to device notifications. 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.
  • Page 35 be managed using the multifunction button, the AB Remote mobile application, or the Phonak RemoteControl. Pairing the Naída CI M90 to Phonak Accessories Your Naída CI M90 can be paired to the following Phonak accessories: • Phonak RemoteControl • Phonak TV Connector •...

  • Page 36: Care And Maintenance

    be switched into flight mode. Entering flight 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.

  • Page 37: Cleaning And Maintenance

    Recommended Operating, Storage Temperature, and Humidity Ranges oNditioN iNimum aximum Operating Temperature 0˚C (32˚F) 45˚C (115˚F) Storage Temperature -20˚C (-13˚F) 55˚C (131˚F) Relative Humidity Cleaning and Maintenance Wipe the outside of the Naída CI M90 with a soft, dry cloth. Do not immerse in liquids or use cleaning agents for cleaning the sound processor.
  • Page 38 • The Naída CI M90 sound processor with the M Listening Check, an M Battery or M Zn-Air Battery Pak, a M T-Mic, M Earhook, or M Acoustic Earhook, and a headpiece. The following product configuration has an IP rating of 52 (protection against dust; protection against failure due to dripping water when tilted up to 15º): •...
  • Page 39 Dispose of the Naída CI M90 sound processor and accessories in accordance with applicable national and local regulations. Hazardous materials: not applicable to this product. AVAILABLE PRODUCT OPTIONS AND MODEL NUMBERS roduCt PtioN odel umBer Sand Beige CI-5293-120 Chestnut CI-5293-130 Silver Grey CI-5293-140 Velvet Black CI-5293-150...
  • Page 40 Resin Beige CI-5293-240 CLINICAL BENEFITS Advanced Bionics conducted two clinical studies of AutoSense OS on the Naída CI M90 sound processor. Results from both studies are reported below: the first summary provides results from a confirmatory study conducted at Advanced Bionics’ location in Valencia, CA and the second summary provides results from both this confirmatory study and a multicenter pivotal trial conducted across the United States.
  • Page 41 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. oS o eNSe eNSe Verage Core Verage Core Mean (SD) 88.92 (11.068) 89.76 (11.677) Median...
  • Page 42 oS o eNSe eNSe Verage Core Verage Core Mean (SD) 79.29 (16.439) 54.19 (23.826) Median 86.98 57.53 Min, Max 45.8, 95.3 19.8, 81.4 In quiet, 100% of subjects’ AutoSense OS scores were within 10% of their AutoSense OS Off scores and in noise 90% of subjects’ AutoSense OS scores were better than their AutoSense OS Off scores by 10% or more.
  • Page 43 that listening in quiet was comfortable. Nine subjects (90.0%) agreed that listening in noise was comfortable (7 subjects reported “Strongly Agree,” 2 subjects reported “Slightly Agree”), with 1 subject reporting slight disagreement. All 10 subjects (100.0%) reported that AutoSense OS on the sound processor was acceptable for use and daily wear, with 8 subjects (80.0%) reporting strong agreement and 2 subjects (20.0%) reporting slight agreement with the statements “The sound processor is acceptable for use”...
  • Page 44 Sentences in Noise at 65 dBA, + 5 dB SNR Multi-Talker Babble Across all subjects, better sentence recognition scores in noise were observed when using AutoSense OS as compared to the AutoSense OS Off program. See table below. oS o eNSe eNSe Verage...
  • Page 45 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 • WindBlock: The intent of the WindBlock sound processing feature is to reduce wind noise arriving at the microphone to improve comfort and ease of listening when listening in the presence of wind.
  • Page 46 mode depending on the surrounding noise in the environment. UltraZoom can be enabled in a static mode, which is referred to as Fixed Directional mode. • StereoZoom: The StereoZoom feature is designed only for use with bilateral recipients. The intent of this feature is to use a bilateral beamformer to create a narrow beam to focus on one person in front of you when in a noisy environment.
  • Page 47 the listening environment. The AutoSense program is enabled by default as the start-up program. Modification of Program Settings The front end processing features have been designed specifically to remove unwanted extraneous or background noise. These features have default values that are a starting point for hearing care professionals to use in the fitting process. If you think that you would benefit from changing your program settings from the current settings, you should contact your hearing care professional’s office and request the option to have additional settings to use in your real-world environment.
  • Page 48 • The Naída CI sound processor is designed so it can be worn in an off-ear wearing configuration. We do not recommend the processor be worn in the off-ear wearing configuration while using any beamforming algorithm. • The intent of the WindBlock, EchoBlock, SoundRelax, and NoiseBlock algorithms is to attenuate a portion of the signal in order to provide comfort in specific environments.
  • Page 49 GUIDELINES FOR IT SECURITY Intended Use Environment The Naída CI M90 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 M90 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.

  • Page 50: System Interfaces

    System and Network Diagram Cochlear Headpiece CPI-3 Implant RF Cable USB Cable Programming Cable Sound Fitting Processor Software Bluetooth Bluetooth USB Cable Remote Control / Mobile Application Noahlink (Volume and Program Changes) Wireless System Interfaces Sound Processor omPoNeNt Bluetooth NterfaCe Bidirectional raNSfer ireCtioN...
  • Page 51 Bluetooth Classic: Audio/Video Remote Control Profile v1.5 (AVCTP v1.4 over L2CAP) Bluetooth Classic: E0 encryption eCurity Bluetooth LE: AES-CCM 128 encryption Sound Processor omPoNeNt NterfaCe Bidirectional raNSfer ireCtioN Advanced Bionics proprietary ommuNiCatioN rotoCol None eCurity Remote Control omPoNeNt Bluetooth NterfaCe...
  • Page 52 Bidirectional raNSfer ireCtioN Bluetooth LE: Proprietary GATT (Generic Attribute Profile) over L2CAP ommuNiCatioN rotoCol Bluetooth LE: AES-CCM 128 encryption eCurity Roger Devices omPoNeNt Roger DMl NterfaCe Bidirectional raNSfer ireCtioN Phonak proprietary ommuNiCatioN rotoCol 32-bit code defining address and hopping sequence eCurity TV Connector PartnerMic omPoNeNt...
  • Page 53 Phonak proprietary ommuNiCatioN rotoCol AES-CTR 128 encryption eCurity Cybersecurity Configuration There is no specific Naída CI M90 sound processor configuration needed to help ensure cybersecurity. Ensure pairing with Bluetooth devices is completed in a secure environment such as at home or in the clinician’s office. Integrated Cybersecurity Functions The Naída CI M90 system does not include user authorization or authentication mechanisms.
  • Page 54 Users of the Naída CI M90 sound processor are trained by their cochlear implant professional at the initial fitting session. End of Cybersecurity Support Advanced Bionics products are supported until they no longer have regulatory approval in the country of use or until the product is obsolesced by Advanced Bionics.

  • Page 55: Guidance And Manufacturer's Declaration

    GUIDANCE AND MANUFACTURER’S DECLARATION Per IEC 60601-1-2 Electromagnetic Emissions miSSioNS omPliaNCe leCtromagNetiC NViroNmeNt uidaNCe RF emissions CISPR 11 Group 1 The Naída CI M90 sound processor uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

  • Page 56: Electromagnetic Immunity

    Electromagnetic Immunity The Naída CI M90 sound processor is intended for use in the electromagnetic environment specified below. The customer or the user of the Naída CI M90 sound processor should assure that it is used in such an environment. ieC 60601 mmuNity omPliaNCe...
  • Page 57 ieC 60601 mmuNity omPliaNCe leCtromagNetiC NViroNmeNt uidaNCe ª eVel eVel Radiated RF 10 V/m 10 V/m Portable and mobile RF communications equipment should IEC 61000-4-3 80 MHz to be used no closer to any part of the Naída CI, including 2.5 GHz cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.Recommended separation distance:...
  • Page 58 a. Essential performance of the Naída CI per IEC 60601 requirements is defined as auditory stimulation and acoustic amplifications are within safe amplitudes and does not create an overly loud sound. b. Field strengths from fixed transmitters, such as base stations for radio (cellular/ cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy.
  • Page 59 Separation Distances between RF Communications Equipment and Naída CI M90 rf C eCommeNded eParatioN iStaNCeS BetweeN ortaBle aNd oBile ommuNiCatioNS Ci m90 quiPmeNt aNd the aída The Naída CI is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
  • Page 60 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.

  • Page 61: Quality Of Service

    Quality of Service The proprietary wireless communication protocol used to connect to Phonak wireless accessories meets a Quality of Service of an audio error rate of 0.008 which translates to a maximum of 2 missed audio frames per second and maintains good audio quality. The Sonova Binaural Protocol used to communicate between hearing instruments meets a Quality of Service of a frame error rate (FER) of 1.6% to maintain good audio quality.
  • Page 62 • A unique pairing key established at pairing time for DM devices which is validated during transmission • A cyclic redundancy check (CRC) which ensures the integrity of remote-control and audio data. • A system architecture that isolates the processor’s critical functionality of stimulation parameters from the wireless functionality Bluetooth safety features have been implemented according to the Bluetooth SIG requirements and tested according to those specifications.
  • Page 63 Portable RF communications equipment (including devices such as antenna cables and external antennas) should be used no closer than 12 inches (30 cm) to any part of the Naída CI M90 sound processor, including the headpiece cable. Decreased performance of the sound processor, headpiece, or other accessories could result (e.g., poor sound quality, cutouts in sound, delay in response when making adjustments, or loss of lock).
  • Page 64 Radio Information for your Sound Processor Antenna type Magnetic loop antenna Operation frequency 2.4 GHz – 2.48 GHz Modulation GFSK Radiated power <2.5mW Bluetooth Range Bluetooth 4.2 Dual-Mode Profiles supported HFP (Hands-Free Profile), A2DP This instrument is certified under: • FCC ID: 2AU6O-ABBTE2 •...
  • Page 65 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. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules.
  • Page 66 • Reorient or relocate the receiving antenna. • Increase the separation between the equipment and receiver. • Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. • Consult your cochlear implant professional or an experienced radio/TV technician for help.
  • Page 68 Advanced Bionics AG Laubisrütistrasse 28 8712 Stäfa, Switzerland +41 58 928 78 00 Manufactured by: Advanced Bionics LLC California, U.S.A. +1 661 362 1400 AdvancedBionics.com 029-M796-02 029-M796-02 Rev A 2021-05-19 ©2021 Advanced Bionics AG. All Rights Reserved.

This manual is also suitable for:

Ci m90Ci-5293-120Ci-5293-130Ci-5293-140Ci-5293-150Ci-5293-110 ... Show all

Table of Contents