Advanced Bionics ABBTE Wireless Hearing Instrument User Manual Naida CI IFU cover

Advanced Bionics AG Wireless Hearing Instrument Naida CI IFU cover

User Manual Naida CI

029-M304-85 Rev PCManufactured by:Advanced Bionics LLCCalifornia, U.S.A.+1 661 362 1400AdvancedBionics.com© 2012 Advanced Bionics AG. All Rights Reserved. Advanced Bionics AGLaubisrütistrasse 288712 Stäfa, Switzerland+41 58 928 78 00Naída CI Q70CI-5245instructions for useEnglish, French, Spanish, German, Dutch, Portuguese 2013
1Labeling symbols and their meanings:European Community Mark of Conformity. Authorized to affix the CE Mark in 20xxModel numberDate of manufactureSerial Number Manufacturer Type of Protection: BStore at temperatures between -20˚C (-4˚F) and +55˚C (131˚F)Fragile Do not get wetLot Number See Instructions for UseSuitable for atmospheric range between 70kPa and106kPa, which is equivalent to 3000m above sea level to 380m below sea level.Suitable for exposure to relative humidity between 0-95%Dispose of in accordance with applicable national and local regulationsThe Naída CI carries a rating of IP57. This rating indicates that the Naída CI is protected against the following conditions:•Protection against dust•Failure due to one time immersion for 30 minutes to a depth up to 1m and after drying overnight in a dry and store unitREF2000-00095IP57SNLOT
2Warnings and CautionsWarnings• CHOKING HAZARD: contains small parts that pose a hazard of inhalation or choking. • Do not use a ComPilot if recipient has a pacemaker, as there is potential for interference. Contact a healthcare professional for more information.• Do not use or store the AB myPilot in shirt pockets if the recipient has a pacemaker, as there is potential for interference. Contact a healthcare professional for more information.• Ensure appropriate supervision when child is wearing the Naida CI sound processor and accessories.• Keep batteries and accessories out of children’s reach as they may pose a choking hazard.• If any parts are swallowed consult a physician or hospital immediately.• Do not allow children to play with or leave them unattended with batteries.• Do not place batteries in your mouth.• Do not chew or swallow batteries. If this occurs, seek immediate medical attention.• Do not allow children to play with or operate the Zephyr by Dry & Store® or desiccant unattended.• Using your sound processor and accessories contradictory to their intended use (e.g. mouthing, chewing) may cause bodily harm • Do not recharge disposable batteries.• Do not allow leaking battery fluid to come into contact with skin, mouth, or eyes.Zephr by Dry & Store® is a registered trademark of Ear Technology Corporation
3• Do not expose batteries to heat (e.g., do not store in direct sunlight or in a hot car).• Do not dispose of batteries in fire.• Do not allow children to charge batteries unattended.• Do not use any other power supply with the sound processor, AB myPilot remote control or ComPilot unless it is supplied by Advanced Bionics or Phonak. If needed call Advanced Bionics for a power supply replacement. • Do not use the AB myPilot or the ComPilot when they are plugged in to power sources such as wall outlets or other power sources that are USB compatible such as laptops.• The ComPilot comes with a neck loop antenna; do not touch the neck loop connectors at the same time.• Power supplies and battery chargers should be operated in an open area to ensure adequate airflow. 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.Cautions• Remove external equipment to stop stimulation if uncomfortable sounds are heard.• It is important to have the correct magnet strength so the recipient does not experience discomfort or retention issues. If an insufficient number of magnets is used in the headpiece, it may fall off more than is acceptable. If too many magnets are used in the headpiece, you may experience irritation or discomfort. Consult a clinician if there are any concerns regarding magnet strength. If deemed appropriate, an
4audiologist may insert additional magnets or remove magnets from the headpiece. Do not place additional magnets in the headpiece unless under the direction of a cochlear implant professional. If the recipient experiences any redness, irritation, or discomfort, discontinue use of the headpiece immediately and contact a cochlear implant center. See the headpiece “Instructions for Use” for additional information regarding adjustment of headpiece magnet strength.• If the sound processor or accessories become unusually hot, or warm, discontinue use immediately and contact Advanced Bionics or a clinician.• Store additional headpieces away from items with magnetic strips (e.g. credit cards, hotel room key cards), as this may de-magnetize cards.• Portable and mobile RF communications equipment, including radios and cellular phones, may affect sound quality of the Naida CI sound processor and accessories; however, there is no safety hazard associated with such equipment.• The Naida CI sound processor and accessories should be used in accordance with the electromagnetic compatibility (EMC) information provided in the ‘Guidance and Manufacturer’s Declaration’ section of this Instructions for Use.• Only use the charger provided for charging AB PowerCel™ batteries. DO NOT use it to charge other batteries. Do not try to charge Naida CI PowerCels using a charger other than the one provided by Advanced Bionics.• Remove batteries from your sound processor when they are drained to prevent damage from possible leaking.• Do not expose any part of the Naida CI sound
5processor or accessories to extreme heat, such as an oven, microwave or hair dryer.• Do not use your AB myPilot or ComPilot accessories when instructed not to use wireless electronic devices, such as on airplanes.• The AB myPilot should not come within 1 cm (1/2”) of the Naida CI processor while stimulating the implant. Doing so could cause the implant and sound processor to lose lock. If this happens, power down the processor and re-power on (done by disengaging the battery and reattaching).• The digitally-coded, inductive transmission technology used in this device is extremely reliable and experiences virtually no interference from other devices. It should be noted, however, that when operating the device near a computer terminal or other strong electromagnetic fields, it may be necessary to be at least 60 cm (24”) away to ensure proper operation. If the Naida CI does not respond to the implant device because of an unusual field disturbance, move away from the disturbing field.• If the AB myPilot stops being able to transmit commands to the sound processor, it may be necessary to re-pair the AB myPilot with your sound processor. Consult the previous section of this user manual for instructions on re-pairing the AB myPilot.• If volume commands from your AB myPilot to your sound processor seem erratic, re-pair the AB myPilot and the Naida CI. • Ultrazoom will dampen sounds that are not in front of the recipient. • Do not use Ultrazoom in an off-the-ear wearing configuration.
6The Naida CI is a behind-the-ear (BTE) sound processor that converts sound picked up by the microphone into electrical signals that are used by the cochlear implant to enable hearing.
7Using the Naída CI Q70 Sound ProcessorPowering the Naída CIThe processor is turned ‘on’ when a charged battery is attached to the processor. In order to power ‘off’ the processor, the battery cartridge must be removed. When the battery is engaged, the orange LED located in the middle of the rocker switch will flash to indicate battery charge. The Naída CI will always power on in Program 1 with the volume and sensitivity at the default settings. To power down the Naída CI, simply remove the battery cartridge.Note: The T-Mic 2 Cover should be replaced at regular intervals to maintain sound quality.Removing the Battery 1Hold the Naída CI in one hand. In the other hand hold the battery cartridge. Rotate RF cable upward in order to avoid bumping it upon battery removal.
8 2Firmly slide the battery cartridge away from the earhook or T-Mic 2. 3Continue sliding the battery cartridge until it separates from the processor.Replacing the Battery 1Hold the Naída CI in one hand. Rotate RF cable upward in order to avoid bumping it upon battery placement
9 2Align the battery cartridge connector with the processor housing side of the connector. 3 Slide the battery onto the processor until it clicks into place.NOTE: Do not force the battery cartridge onto the processor. The battery cartridges are designed to be inserted in only one direction; applying force may damage the equipment.
10Understanding Naída CI LEDsThe LED is a programmable feature providing visual information about Naída CI status, battery life, program position, and sound processor error conditions.Color Behavior Programmable IndicationOrange Blinks at start-up Battery indicator is only available with use of the rechargeable PowerCels and the Naída CI Power Adapter. Battery life indicators are not available with Zn-Air cells.• 4 quick blinks indi-cate that the battery is fully charged• 2 - 3 quick blinks indicate that the battery is sufficiently charged to power the Naída CI • 1 quick blink indi-cates that the battery is nearly depleted• No blinking indicates depleted battery. Re-place with charged or new batterySolid Yes The battery is almost depletedBlinks twice every three secondsYes The battery is depleted and cannot support stimulation (Sleep Mode)Fades OutNo Naída CI entering Standby Mode
11Color Behavior Programmable IndicationRed Blinks once per secondYes Loss of lock with the implantBlinks rapidly (more than once per second)No IntelliLink™: Wrong implant connectedSolid No Sound processor error condition. Fully remove and re-insert battery to reset processorBlinks 5 timesNo - if using AB myPilot, this pattern is the defaultResponse to AB myPilot’s request to ‘Find Paired Devices’. The right paired device will identify itself with this LED pattern
12Color Behavior Programmable IndicationGreen Flickers in response to loud inputsYes The sound processor and microphone are responding to soundBlinks at start-up after battery status and upon program changeNo • 1 blink indicates program one• 2 blinks indicate program two• 3 blinks indicate program three• 4 blinks indicate program four• 5 blinks indicate program fiveSolid No A processor that is not yet programmed.Blinks 4 times No - if using AB myPilot, this pattern is the defaultResponse to AB myPilot’s request to ‘Find Paired Devices’. The left paired device will identify itself with this LED pattern Note: Use of some Naída CI accessories may obscure the processor LED.
13If the user would like to know the battery status of the Zn-Air cells they are currently using and have an AB myPilot paired to their device, they can conduct a Battery Check readout of the Naída CI. The Battery Check readout must be performed 15 minutes after the Zn-Air cartridge has been attached to the Naída CI. After this short window of time the AB myPilot will be able to give an accurate reading of the Zn-Air cells in use by the Naída CI.Please see the ‘Battery Check’ section of the AB myPilot User Guide for instructions on how to conduct battery status check using AB myPilot.Approved Naída CI Power SuppliesPower Supply Rated VoltageType Rated Energy/PowerPowerCel 3.7V Li-ion (Rechargeable)0.4 Wh- 0.9 WhZn-Air 2.8V Zn-Air (Disposable)1,240mWhProgramming Interface5.0V DC 1,250mW
14Understanding Naída CI Internal AlarmsBehavior Programmable IndicationBeeps upon program changeYes • 1 beep indicates program one• 2 beeps indicate program two• 3 beeps indicate program three• 4 beeps indicate program four• 5 beeps indicate program five Short Beep upon increase/decrease in volumeYes Beeps once per press of the rocker switch either up or down (a double beep will be heard when the following settings are reached: top of the volume range; baseline volume setting; and bottom of the volume range)Long Beep (once every 15 minutes)Yes Low battery
15Recommended Operating and Storage Temperature RangesCondition Minimum MaximumOperating Temperature 0°C (32°F) 45°C (115°F)Storage Temperature -20°C (-4°F) 55°C (131°F)Naída CI External Equipment and AccessoriesModel Number DescriptionCI-5245-xxx Naída CI Sound Processor*CI-5305 Universal Headpiece (UHP)*CI-5605 Naída CI PowerCel ChargerCI-5615 Charger Power Supply with adaptersCI-5415-xxx Naída CI RF Cable*CI-5511-xxx Naída CI PowerCel 110*CI-5517-xxx Naída CI PowerCel 170*CI-5523-xxx Naída CI PowerCel 230*CI-5500-xxx Naída CI Zn-Air Battery Pak*070-M006 Zn-Air Battery 6pk*Applied part per IEC 60601-1Note: The X’s denote model number variant related to product color and/or length.
16Guidance & Manufacturer’s DeclarationPer IEC 60601-1-2Electromagnetic emissionsEmissions test Compliance Electromagnetic environment - guidance RF emissions CISPR 11 Group 1 The Naída CI 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.RF emissions CISPR 11 Class B The Naída CI is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.Harmonic emissions IEC 61000-3-2Not applicableVoltage fluctuations/ flicker emissions IEC 61000-3-3Not applicable
17Electromagnetic immunityThe Naída CI is intended for use in the electromagnetic environment specified below. The customer or the user of the Naída CI should assure that it is used in such an environment. Immunity IEC 60601 test levelCompliance levelaElectromagnetic environment - guidanceElectrostatic discharge (ESD) IEC 61000-4-2 ± 6 kV contact ± 8 kV air ± 6 kV contact ± 8 kV air 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.Power frequency (50/60 Hz) Magnetic Field IEC 61000-4-8 3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
18Radiated RF IEC 61000-4-33 V/m 80 MHz to 2.5 GHz 33 V/mPortable and mobile RFcommunications equipment should be used no closer to any part of the Naída CI, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = 1.2√P < 800 MHz d = 2.3√P ≥ 800 MHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site 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:
19Note 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. 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. To assess the electro- magnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Naida CI is used exceeds the applicable RF compliance level above, the Naida CI should be observed to verify normal operation.c. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
20Separation distances between RF communications equipment and Naída CIRecommended separation distances between portable and mobile RF communications equipment and the Naída CIThe Naída CI is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Naída CI can help prevent electromagnetic inter-ference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Naída CI as recommended below, according to the maximum output power of the communications equipment.Rated Maximum Output Power of Transmitter (w)Separation distance according to frequency of transmitter (m)d = 1.2√P < 800 MHzd = 2.3√P ≥ 800 MHz0.01 0.12 0.230.1 0.38 0.7311.2 2.310 3.8 7.3100 12 23For 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.
21Note 1: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.Compatibility TablesImplant TypeProcessor TypeC1 CII HiRes 90KHiRes 90KAdvantageNaída CI -✓5✓5✓5Neptune -✓ 1✓1✓1Harmony ✓2✓3✓3✓1Auria -✓3✓3✓1Platinum Sound Processor (PSP) ✓4✓ ✓ ✓11 Requires SoundWave 2.1 or later2 Requires SoundWave 2.0 or later 3 Requires SoundWave 1.4 or later4 Requires SClin2000 and CPI-II5 Requires SoundWave 2.2 and CPI-3
22Implant TypeSoftware Type/VersionC1 CII HiRes 90KHiRes 90K AdvantageSClin2000 ✓ ✓ - -SoundWave (versions 1.x)-✓ ✓ -SoundWave 2.0 ✓1✓ ✓ -SoundWave 2.1 ✓1✓ ✓ ✓SoundWave 2.2 ✓1✓ ✓ ✓1 Only on HarmonyHeadpiece TypeProcessor TypeUniversal Head-piece (UHP) Aqua-MicAuria Head-piecePlatinum Head-piece(PHP)Naída CI ✓ ✓ - -Neptune ✓ ✓ - -Harmony ✓-✓ ✓Auria ✓-✓ ✓PSP ✓- - ✓
23Programming InterfaceC1 CII HiRes 90K HiRes 90K AdvantageCPI-II ✓ ✓ ✓ ✓CPI-3 ✓1✓ ✓ ✓1 Only on HarmonyCleaning & Maintenance• Clean with a soft cloth. Do not immerse.• Do not attempt to service or modify the Naida 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.Performance DataThe HiRes 90K™ Advantage implant with the HiFocus™ Electrode and Naída CI processor support the HiResolution family of sound processing strategies including HiRes, HiRes with Fidelity 120 (HiRes 120), and ClearVoice.HiRes™ and HiRes 120™ Sound ProcessingA clinical study was conducted in 50 adults implanted with a CII/HiRes 90K device who used a Harmony processor to document the benefits of HiRes 120 and
24HiRes sound processing. Performance with HiRes was assessed at the baseline visit and compared with HiRes 120 performance after three months of listening experi-ence. Subsequently, subjects were refit and retested with HiRes. Results showed equivalent mean CNC word recognition scores for the two strategies. The mean HINT sentence perception scores in quiet and noise were significantly higher for HiRes 120 compared to baseline with HiRes. For HINT sentences in noise, the mean scores for HiRes 120 were significantly higher than scores after subjects were refit with HiRes.Table 1Mean Speech Scores for HiRes and HiRes 120Sound Processing Group HiRes HiRes 120 HiRes Test Interval Baseline 3 Months 3 MonthsCNC Words 63 65 63HINT Sentences in Quiet 88 93* 91Hint Sentences in Noise (+8 dB SNR)64 70** 65* HiRes 120 score significantly different from baseline HiRes score (p<.05)**HiRes 120 score significantly different from baseline and 3-month HiRes scores (p<.05)
25Forty-three of 50 subjects (86%) preferred HiRes 120 over HiRes. Subjects rated strength of preference for the two strategies on a scale from 1 (weak preference) to 10 (strong preference). The mean strength of prefer-ence for the 43 subjects who preferred HiRes 120 was 7.9 (range: 1-10). The strength of preference was rated as 8 or higher by 26 of the 43 subjects, and 16 of the 43 subjects rated their preference as 10 (strong prefer-ence). For the 7 subjects who preferred HiRes, the mean strength of preference was 4.4 (range: 1-9).ClearVoiceA clinical study was conducted in 46 adults who had at least six months experience with HiRes 120 sound pro-cessing and at least moderate speech perception abili-ties to investigate the benefits of ClearVoice. ClearVoice has three adaptive gain settings that allow individuals to select the setting that provides the best hearing—Low, Medium, and High. A two-week randomized, crossover design was used to evaluate ClearVoice-Medium and ClearVoice-High. ClearVoice-Low was evaluated acutely during an initial test session. Speech benefit was com-pared for ClearVoice vs. HiRes 120 without ClearVoice (Control) using the AzBio sentence test.Speech understanding in speech-spectrum noise was significantly better with ClearVoice- Medium and ClearVoice-High compared to the Control (p < .0001).
26ClearVoice-Medium significantly improved speech understanding in multi-talker babble (p< .02). Speech understanding was no worse than the Control when listening in quiet for both ClearVoice-Medium and ClearVoice-High (p < .0001). Speech understanding with ClearVoice-Low was no worse than the Control in quiet, in speech-spectrum noise, and in multi-talker babble (p <.001).Table 2Mean AzBio Sentence Scores for HiRes 120 with and without ClearVoiceStudy Group ControlClear-Voice LowControlClear-Voice MediumControlClear-Voice HighQuiet 87.3 87.8 88.6 88.3 86.8 87.7Speech-Spectrum Noise48.0 55.6 49.5 58.2 47.7 58.3Multi-Talker Babble42.8 47.2 44.9 48.1 44.9 46.2Preference ratings indicated that 42 out of 45 subjects (93%) preferred ClearVoice to the Control for everyday listening (one subject did not complete the question-naire). The mean strength of preference for the 42 subjects who preferred ClearVoice was 7.9 (1 = weak preference, 10 = strong preference). Of the 42 subjects preferring ClearVoice, 22 indicated they would use it all
27of the time, 17 indicated they would use it most of the time, and 3 indicated they would use it some of the time. Of the 3 subjects preferring the Control, all indicated they would use ClearVoice some of the time. ClearVoice is not approved for pediatric use in the United States.ClearVoice is only available in markets where ClearVoice has received regulatory approval. Contact Advanced Bionics for more information.This instrument is certified under:FCC ID: S2B-ABBTEIC: 10870A-ABBTEThis device complies with Part 15 of the FCC Rulesand with RSS-210 of Industry Canada. Operation issubject to the following two conditions:1) this device may not cause harmful interference, and2) this device must accept any interference received,including interference that may cause undesiredoperation.Changes or modifications made to this equipmentnot expressly approved by Advanced Bionics may void the FCC authorization to operate this equipment.
28This Class B digital apparatus complies with CanadianICES-003.This equipment has been tested and found to complywith the limits for a Class B digital device, pursuant toPart 15 of the FCC Rules.These limits are designed to provide reasonableprotection against harmful interference in a residentialinstallation. This equipment generates, uses, and canradiate radio frequency energy and, if not installed andused in accordance with the instructions, may causeharmful interference to radio communications. However,there is no guarantee that interference will not occurin a particular installation.If this equipment does cause harmful interference toradio or television reception, which can be determinedby turning the equipment off and on, the user isencouraged to try to correct the interference by one ormore of the following measures:• 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 clinic or an experienced radio/TV technician for help

Navigation menu