Sivantos BTE001 BTE hearing instrument User Manual Safety manual English

Sivantos GmbH BTE hearing instrument Safety manual English

Contents

Safety manual English

DRAFT 2017-07-27Safety manual for hearing instrumentsfor US and Canadian markets Master
DRAFT 2017-07-272ContentSafety information  3Intended use  3Explanation of symbols  3General warnings  4For certain inrument types  12For children under the age of 3 years  13For certain battery types  14When using remote control apps  15For Hearing Care Professionals  16Important information  17Operating, transport and orage conditions  17Disposal information  18Conformance information  18For US and Canadian markets only  21For prospective hearing inrument users  21For hearing inrument users  22Tinnitus feature  30For children with hearing loss  33Warranty and service  34
3DRAFT 2017-07-27 Safety informationThis safety manual provides safety information and other important information about your hearing inruments. It covers several inrument types and optional features. XRefer to the user guide of your hearing inruments, to check the inrument type and the activated features. Intended useHearing inruments are intended to improve the hearing of hearing impaired persons. Diagnosis and prescription of a hearing inrument mu be performed by hearing health specialis, e.g. acouicians, audiologis or ENT doctors.Use the hearing inruments and accessories only as described in the respective user guides. Explanation of symbolsSymbols used in this documentPoints out a situation that could lead to serious, moderate, or minor injuries.Indicates possible property damage.Information and warnings for children with hearing inruments.
4DRAFT 2017-07-27Symbols on the device or packagingCE compliance label, conrms compliance with certain European Directives, refer to section "Conformance information".EMC and radio communications compliance label Auralia, refer to section "Conformance information".Optional symbol for cuom models with wireless functionality.Indicates the legal manufacturer of the device.Do not dispose of the device with general domeic wae. Read more in section "Disposal information".Read and follow the inructions in the user guide. General warningsWARNING Risk of impairing the residual hearing of the user. XUse only hearing inruments that have been tted especially for your needs.WARNING Risk of injury! XDo not use obviously damaged devices and return them to point of sale.
5DRAFT 2017-07-27WARNINGNote that any unauthorized changes to the product may cause damage to the product or cause injury. XUse only approved parts and accessories. Ask your Hearing Care Professional for support.WARNINGYour hearing inruments may reduce certain background sounds, potentially also trac or warning signals.WARNINGRisk of explosion! XDo not use your hearing inruments in explosive atmospheres (e. g. in mining areas).WARNINGChoking hazard!Your hearing inruments contain small parts which can be swallowed. XKeep hearing inruments, batteries and accessories out of reach of children and mentally disabled persons. XIf parts have been swallowed consult a physician or hospital immediately.If you have hearing inruments that are intended for the tting of children under the age of 3 years or persons with a developmental age of under 3 years, refer also to section "For children under the age of 3 years".
6DRAFT 2017-07-27NOTICE XProtect your hearing inruments from high humidity. Do not wear them in the shower or when you apply make-up, perfume, aftershave, hairspray or suntan lotion.NOTICE XProtect your hearing inruments from extreme heat. Do not expose them to direct sunlight.NOTICE XDo not dry your hearing inruments in the microwave oven.NOTICEDierent types of rong radiation, e. g. during X-ray or MRI head examinations, may damage hearing inruments. XDo not wear the hearing inruments during these or similar procedures.Weaker radiation, e. g. from radio equipment or airport security, does not damage the hearing inruments.NOTICEYour devices comply with international andards.However, it cannot be guaranteed that all products on the market work interference-free, for example some induction cookers may cause audible interference.
7DRAFT 2017-07-27ContraindicationsWARNINGConsult a Hearing Care Professional if you experience any unusual side eects like skin irritation, excessive accumulation of ear wax, dizziness, change in your hearing, or if you think there may be a foreign object in your ear canal. WARNINGA Hearing Care Professional should advise a prospective hearing inrument user to consult a licensed physician before using the hearing inrument if the Hearing Care Professional determines that the prospective user has any of the following conditions: XVisible congenital or traumatic deformity of the ear. XHiory of active drainage from the ear within the previous 90 days. XHiory of sudden or rapidly progressive hearing loss within the previous 90 days. XAcute or chronic dizziness. XUnilateral hearing loss of sudden or recent onset within the previous 90 days. XAudiometric air‑bone gap equal to or greater than 15 dB at 500 Hz, 1,000 Hz, and 2,000 Hz. XVisible evidence of signicant cerumen accumulation or a foreign body in the ear canal. XPain or discomfort in the ear.
8DRAFT 2017-07-27For hearing inruments with wireless functionalityIn some countries rerictions for the usage of wireless equipment exi. XRefer to local authorities for further information.WARNINGRisk of aecting electronic equipment! XIn areas where the use of electronics or wireless devices are rericted, verify if your device has to be turned o.NOTICEYour hearing inruments are designed to comply with international andards on electromagnetic compatibility but interference with nearby electronic devices could occur. In this case, move away from the source of interference.
9DRAFT 2017-07-27For hearing inruments with a tinnitus featureYour hearing inrument may be equipped with a tinnitus feature (e. g. with a tinnitus therapy signal, a tinnitus noiser, or another special function). The use of the tinnitus feature should be only on the advice and in consultation with your Hearing Care Professional.WARNINGRisk of further impairment to the user’s hearing health.The volume of the tinnitus feature can be set to a level which could lead to permanent hearing damage when used for a prolonged period of time. XThe tinnitus feature should never be used at uncomfortable levels.
10DRAFT 2017-07-27For hearing inruments with AutoPhone magnetWARNINGRisk of aecting life support syems! XUse a magnet only when it is a safe diance away from life support syems, such as pacemakers or magnetic valves. For example, the safe diance between pacemaker and magnet should be at lea 10 cm (4 inches).NOTICEMagnets can diurb electrical devices and delete ored data. XKeep magnets away from computers, monitors, television sets, orage media and other electronic equipment/devices.NOTICEIn close proximity, AutoPhone magnets can damage receiver units of RIC hearing inruments. XKeep a minimum diance of 2 cm between the RIC receiver and any magnet, including the AutoPhone magnet.For example, do not ore your RIC hearing inruments and a smartphone with attached AutoPhone magnet together in a small pocket or box.
11DRAFT 2017-07-27For hearing inruments with a magnet in the battery compartmentWARNINGRisk of interference with active and non-active implants!If you wear an active or a non‑active implant, e.g. a brain implant: XPrior to use, have the electromagnetic compatibility veried.Consult the physician that implanted the device before using your hearing inruments. XKeep a safe diance of about 1.6 inches (4 cm) between the implant and hearing inruments.
12DRAFT 2017-07-27 For certain instrument types BTE modelsInruments that are worn behind the ear and that have a tube.CAUTION Risk of injury! XAlways wear the tube with an ear piece. XMake sure that the ear piece is completely attached. RIC modelsThe receiver is placed within the ear canal and connected to the inrument via a receiver cable.CAUTION Risk of injury! XAlways wear the receiver cable with an ear piece. XMake sure that the ear piece is completely attached.NOTICE XDo not pull the receiver connection as this could damage your hearing inruments. Other modelsFor all other models, no model‑specic safety information applies.
13DRAFT 2017-07-27For children under the age of 3 yearsThere are special hearing inruments for the tting of children under the age of 3 years or persons with a developmental age of under 3 years. Ask your Hearing Care Professional for further information.WARNINGChoking hazard!Your hearing inruments contain small parts which can be swallowed. XEnsure adequate supervision if infants, small children or mentally disabled persons need to wear hearing inruments. XCheck the completeness of the hearing inruments regularly. XEnsure that your child or the mentally disabled person does not detach the hearing inrument from the earmold. XConsult your Hearing Care Professional if the housing is deformed. XKeep the battery compartment locked. Verify the proper function of the locking mechanism. XKeep batteries and accessories out of children's or mentally disabled person's reach. XIf swallowed consult a physician or a hospital immediately.
14DRAFT 2017-07-27For certain battery typesFor hearing inruments with built-in power cells (lithium-ion rechargeable batteries) Read the safety information on power cells in the hearing inrument's user guide.For hearing inruments with replaceable batteriesNOTICEOnly use zinc-air batteries or nickel-metal hydride (NiMH) rechargeable batteries.Do not use e.g. silver‑zinc or lithium‑ion rechargeable batteries. NOTICELeaking batteries damage the hearing inruments. XTurn the hearing inruments o when not in use to preserve the battery. XRemove batteries when the inruments are not in use for a prolonged period of time.
15DRAFT 2017-07-27When using remote control appsWhen using an app for controlling hearing inruments:WARNINGRisk of hearing damage!The device with the app for controlling hearing inruments generates short control signals which may be audible. If the device running the app has a very high audio output there is the risk of hearing damage.While using the app: XDo not hold the loudspeaker of the device to your ears or the ears of others. XDo not use the device with headphones, headsets or other audio playback devices.
16DRAFT 2017-07-27For Hearing Care ProfessionalsWARNINGFor hearing inruments with an output sound pressure level of 132 dB SPL or more:Risk of impairing the residual hearing of the user. XTake special care when tting this inrument.Tinnitus featureThe target population is primarily the adult population over 21 years of age. The patient may have some control of the level or volume of the signal and the patient should discuss this adjument as well as his or her comfort level and sound of the signal with their Hearing Care Professional.WARNINGRisk of further impairment to the user’s hearing health.The volume of the tinnitus feature can be set to a level which could lead to permanent hearing damage when used for a prolonged period of time. XShould the tinnitus feature be set to such a level in the hearing inrument, advise the user of the maximum amount of time per day he or she should use the tinnitus feature. For example, occupational safety guidelines rerict continuous noise exposure of 80 dBA SPL to 8 hours per day. XThe tinnitus feature should never be used at uncomfortable levels.
17DRAFT 2017-07-27Important informationOperating, transport and storage conditionsFor hearing inruments with built-in power cells (lithium-ion rechargeable batteries)Read the operating, transport and orage conditions in the hearing inrument's user guide.For hearing inruments with replaceable batteriesOperating conditionsTemperature 0 to 50 °C (32 to 122 °F)Relative humidity 5 to 93 %During extended periods of transport and orage, please observe the following conditions:Storage TransportTemperature 10 to 40 °C (50 to 104 °F)‑20 to 60 °C (‑4 to 140 °F)Relative humidity 10 to 80 % 5 to 90 %For other parts, such as batteries, other conditions may apply.
18DRAFT 2017-07-27Disposal information XRecycle hearing inruments, accessories and packaging according to local regulations.For hearing inruments with replaceable batteries XTo avoid environmental pollution, do not throw batteries into household trash. XRecycle or dispose of batteries according to local regulations or return them to your Hearing Care Professional.Conformance informationThe CE mark indicates conformity with the following European directives:■ 93/42/EEC concerning medical devices■ 2011/65/EU RoHS concerning the reriction of hazardous subances■ Only for products with wireless functionality: 2014/53/EU RED concerning radio equipment The full text of the declaration of conformity can be obtained from www.signia‑hearing.com/doc (for hearing inruments manufactured by Signia GmbH) or from www.sivantos.com/doc (for hearing inruments manufactured by Sivantos GmbH).
19DRAFT 2017-07-27The ACMA compliance mark indicates conformity with the electromagnetic interference andards set by the Auralian Communications and Media Authority (ACMA).Devices with the FCC marking comply with the andards of the FCC regarding electromagnetic interference (only for products with wireless functionality).NoticesThis Class B digital apparatus complies with Canadian ICES‑003.Changes or modications made to this equipment not expressly approved by the legal manufacturer may void the FCC authorization to operate this equipment. This device complies with Part 15 of the FCC Rules and with ISED's licence‑exempt RSSs.Operation is subject to the following conditions:■ this device may not cause harmful interference, and■ this device mu accept any interference received, including interference that may cause undesired operation.
20DRAFT 2017-07-27This equipment has been teed and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection again harmful interference in a residential inallation. This equipment generates, uses and can radiate radio frequency energy and, if not inalled and used in accordance with the inructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular inallation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment o and on, the user is encouraged to try to correct the interference by one or more of the following measures:■ Reorient or relocate the receiving antenna.■ Increase the separation between the equipment and receiver.■ Connect the equipment to an outlet on a circuit dierent from that to which the receiver is connected.■ Consult the dealer or an experienced radio/TV technician for help.For body worn operation, this device has been teed and meets the FCC RF exposure guidelines when used with the legal manufacturer’s accessories supplied or designated for this product. Use of other accessories may not ensure compliance with FCC RF exposure guidelines.
21DRAFT 2017-07-27For US and Canadian markets onlyFor prospective hearing instrument usersGood health practice requires that a person with a hearing loss have a medical evaluation by a licensed physician (preferably a physician who specializes in diseases of the ear) before purchasing a hearing inrument. Licensed physicians who specialize in diseases of the ear are often referred to as otolaryngologis, otologis or otorhinolaryngologis. The purpose of medical evaluation is to assure that all medically treatable conditions that may aect hearing are identied and treated before the hearing inrument is purchased.Following the medical evaluation, the physician will give you a written atement that ates that your hearing loss has been medically evaluated and that you may be considered a candidate for hearing inruments. The physician will refer you to a Hearing Care Professional for a hearing inrument evaluation.The Hearing Care Professional will conduct a hearing inrument evaluation to assess your ability to hear with and without hearing inruments. The hearing inrument evaluation will enable the Hearing Care Professional to select and t hearing inruments to your individual needs.If you have reservations about your ability to adapt to amplication, you should inquire about the availability of
22DRAFT 2017-07-27a trial‑rental or purchase‑option program. Many Hearing Care Professionals now oer programs that permit you to wear hearing inruments for a period of time for a nominal fee after which you may decide if you want to purchase them.U.S. federal law rericts the sale of hearing inruments to those individuals who have obtained a medical evaluation from a licensed physician. U.S. federal law permits a fully informed adult to sign a waiver atement declining the medical evaluation for religious or personal beliefs that preclude consultation with a physician. The exercise of such a waiver is not in your be health intere and its use is rongly discouraged.For hearing instrument usersHearing inruments will not reore normal hearing and will not prevent or improve a hearing impairment resulting from organic conditions. In mo cases infrequent use of hearing inruments prohibits the wearer from attaining the full benet from it. The use of hearing inruments is only part of hearing rehabilitation and may need to be supplemented by auditory training and inruction in lip reading.Health considerationsIf soreness or skin irritation develops, discontinue wearing your hearing inruments, and bring the inruments and earmolds to your Hearing Care
23DRAFT 2017-07-27Professional. Minor t adjuments or earmold modication can often correct this condition. If soreness persis, discontinue wearing the hearing inrument and see your physician. If excessive earwax accumulates when wearing your hearing inruments, consult your Hearing Care Professional.Battery tipsIf a battery is accidentially swallowed, seek medical attention immediately, or call the National Battery Hotline collect at (202) 625-3333.Identication informationYour hearing inruments have a serial number imprinted on them. The location of the serial number will vary according to the yle of hearing inrument you have chosen. Record the serial number in your user guide for future reference.The year of manufacture is incorporated into the serial number.For cuom inruments, the year of manufacture is derived from the r two digits. In the following examples, the year of manufacture is 2016.
24DRAFT 2017-07-2716X0123456Rxxxx /xxxx/xx16X0123456Rxx➊➋ ➌ ➍➎ ➏XXXXX/XXX16X123456R➊➋ ➌➍➎➏➊ 16: year manufactured➋ X: facility code where inrument was manufactured➌ Serial number➍ L or R: left or right ear inrument➎ Manufacturer/Diributor➏ ModelXXXXX XX16X123456R➊➋ ➌➍➎ ➏
25DRAFT 2017-07-27For BTE and RIC inruments, the year of manufacture is derived from the second digit:Code (second digit) YearD, E, F 2013G, H 2014L, M 2015N, P 2016Q, R 2017S, T 2018Please note the warranty is based upon the date of purchase, not the date of manufacture. Your Audiologi or Hearing Care Professional can answer any queions you may have about the identifying code on your hearing inrument.
26DRAFT 2017-07-27Wireless functionalityThe following tables summarizes the technical details of the wireless technology:Wireless technology Neareld magnetic inductionAntenna type Inductive antennaAntenna dimensions BTE or RIC models: Ø: 1.9 mm, L: 6.5 mm, respectively, Ø: 2.3 mm, L: 5.7 mm, respectively, Ø: 2.8 mm, L: 4.4 mmCuom models: Ø: 3.3 mm, L: 4.2 mm, respectively, Ø: 2.0 mm, L: 6.7 mmModulation PSK (Phase Shift Key)Magnetic eld rength0.07 A/m, (1 cm2 coil; average) Output power (EIRP) 53 μWEIRP = Equivalent isotropically radiated powerRange < 20 cm between hearing inrumentsCenter frequency 3.28 MHzChannel Single channel radioBandwidth BTE or RIC models: 140 kHzCuom models: 138 kHzData rate 324 kbit/sec (raw channel capacity)Data ow Simplex or semi-duplex capability
27DRAFT 2017-07-27Protocol Random access, no collision avoidanceS.A.R. 2.36 nW/kg (BTE)6.63 nW/kg (cuom models)S.A.R. = Specic Absorption Rate (S.A.R.) based on 10 g ICNIRP teing. Bluetooth® low energy*Wireless technology Radio frequency ‑ Bluetooth low energyAntenna type Electromagnetic dipole antennaAntenna dimensions BTE or RIC models: H: approx. 4 mm, L: approx. 15 mmMagnetic eld rengthnot applicableOutput power (EIRP) 150 μWEIRP = Equivalent isotropically radiated powerRange < 10 m between smartphone/accessory and hearing inrumentsCenter frequency 2.45 GHzChannel 40 channel radioBandwidth 2 MHz per channel* The Bluetooth word mark and logos are owned by the Bluetooth SIG, Inc., and any use of such marks by the legal manufacturer of this product is under licenses. Other trademarks and trade names are those of their respective owners.
28DRAFT 2017-07-27Data rate 1 Mbit/sec, respectively, 2 Mbit/secData ow Simplex or semi-duplex capabilityProtocol Bluetooth network FHSS (Frequency Hopping Spread Spectrum)S.A.R. 1.31 nW/kgS.A.R. = Specic Absorption Rate (S.A.R.) based on 10 g ICNIRP teing. EMI/EMC complianceWireless hearing inruments comply with the following EMC/EMI andards:Standard Te Type Note47 CFR Part 15, Subpart CRF emissions U.S. FCC requirements for intentional radiators.EN 300 330‑1/2 RF emissions including spurious emissionEMC and radio spectrum matters for short range devices in the frequency range 9 kHz ‑ 25 MHz.EN 301 489‑1/3 Immunity, RF and ESDStandard for low power transmitters in the frequency range 9 kHz ‑ 40 GHz.
29DRAFT 2017-07-27Standard Te Type NoteEN 300 328 Signal integrity and emissionsWideband transmission syems; data transmission equipment operating in the 2.4 GHz ISM band and using wide band modulation techniquesIEC 60118‑13 RF immunity International product andard for hearing inruments to ensure adequate immunity to radio interference from mobile telephones.ANSI C63.19 RF immunity American National Standard method of measurement of compatibility between wireless communication devices and hearing inruments.ANSI/AAMI PC69RF emissions Implantable medical device EMC immunity.ISO 14117 RF emissions Implantable medical device EMC immunity.EN 45502‑2‑1 RF emissions Particular requirements for pacemakers.
30DRAFT 2017-07-27Wireless security measuresWireless signal security is assured through the device syem design that includes:■ A built‑in pairing table which species valid and legitimate pairing among units.■ A proprietary communication protocol which checks the package numbers during each transmission.■ A Cyclic Redundancy Check (CRC) to check data validity.■ A convolutional encoder/decoder (Viterbi) to correct errors.The Bluetooth low energy connection uses the security measures that are dened in the Bluetooth low energy andard.Tinnitus featureYour hearing inrument may be equipped with a tinnitus feature. Many tinnitus patients also suer from some degree of hearing loss. Many hearing inruments can be used alone or in combination with the tinnitus feature. The tinnitus feature is xed to a broadband noise that can be adjued by your Hearing Care Professional for your tinnitus therapy.The feature may provide temporary relief of your tinnitus.
31DRAFT 2017-07-27Prescription Use OnlyU.S. federal law rericts this device to sale by or on the order of a doctor or Hearing Care Professional licensed to dispense hearing inruments in your ate. The use of any sound generating tinnitus therapy device should be only on the advice and in consultation with your Hearing Care Professional. Your Hearing Care Professional will properly diagnose and t the device to your personal needs and requirements. This should include its use in a prescribed tinnitus treatment program. Your Hearing Care Professional will also be able to oer the appropriate follow‑up care. It is important that you follow your Hearing Care Professional’s advice and direction regarding such care.There are some potential concerns associated with the use of any sound generating tinnitus therapy device. Discontinue use and seek medical evaluation if any of the following conditions occur:■ Chronic skin irritation on, near, or around the site of device placement.■ Unusual side eects (e.g., dizziness, nausea, headaches, heart palpitations).■ Perceived decrease in auditory function (e.g., decreased loudness, speech not as clear).
32DRAFT 2017-07-27For Hearing Care ProfessionalsIndications for useThe tinnitus feature is a tool to generate sounds to be used in a tinnitus management program to relieve patients suering from tinnitus. The target population is primarily the adult population over 21 years of age. The tinnitus feature is targeted for healthcare professionals treating patients suering from tinnitus, as well as conventional hearing disorders. The tting of the tinnitus feature should be done by a Hearing Care Professional participating in a tinnitus management program.Device descriptionThe tinnitus feature is a software function that generates sound which is programmed into a hearing inrument. Depending on the type of hearing inrument, the hearing inrument may be used in up to three modes of operation: as a hearing inrument, as a tinnitus treatment device, or as a hearing inrument and tinnitus treatment device.When enabled, the tinnitus feature generates the sound and allows a patient’s Hearing Care Professional to design and program appropriate settings for an individually prescribed sound treatment plan. The treatment plan should be used in a tinnitus management program for relief of tinnitus.The tinnitus feature generates a broadband noise signal that varies in frequency and amplitude. These characteriics are adjuable by the Hearing Care
33DRAFT 2017-07-27Professional and are specic to the prescribed therapy designed by the professional for the patient’s needs and comfort. The patient may have some control of the level or volume of the signal and the patient should discuss this adjument as well as his or her comfort level and sound of the signal with their Hearing Care Professional.A Hearing Care Professional should advise a prospective tinnitus feature user to consult promptly with a licensed physician (preferably an ear speciali) before using the tinnitus feature if the Hearing Care Professional determines through inquiry, actual observation, or review or any other available information concerning the prospective user that the prospective user has any of the following conditions:■ Visible congenital or traumatic deformity of the ear.■ Hiory of active drainage from the ear within the previous 90 days.■ Hiory of sudden or rapidly progressive hearing loss within the previous 90 days.■ Acute or chronic dizziness.■ Unilateral hearing loss of sudden or recent onset within the previous 90 days.For children with hearing lossIn addition to seeing a physician for a medical evaluation, a child with a hearing loss should be directed to an audiologi for evaluation and rehabilitation since hearing
34DRAFT 2017-07-27loss may cause problems in language development and the educational and social growth of a child. An audiologi is qualied by training and experience to assi in the evaluation and rehabilitation of a child with a hearing loss.Warranty and serviceYour hearing inrument, with the exception of the battery, is covered by a comprehensive warranty. All covered inrument parts received for warranty service at an authorized service center will be repaired or replaced with new or reconditioned components, without charge, to meet the performance specications for that model. This warranty does not cover malfunctions due to unusual wear and tear or mireatment of the inrument such as physical shock, excessive wax build-up, or tampering with the inrument, any of which voids all warranties. Your Hearing Care Professional may charge a service fee for processing warranty service. Warranty service mu only be performed by an authorized service center. Service performed by unauthorized service depots voids this warranty, and repairs so necessitated will be done on a parts and labor co basis. Please refer to the warranty card included with your hearing inruments for warranty period eective dates.
35DRAFT 2017-07-27Your hearing inruments may have additional loss and damage coverage. Please consult your Hearing Care Professional to determine if this is applicable to your hearing inruments.Risk mitigations (for internal use only)FCC RF exposure | use with accessories ............................................................ 20IFU101 | interference induction cooker | device ..................................................... 6M11 | explosion | HI ................................................................................................ 5M15 | choking | non‑ped HI .................................................................................... 5M18_2/2 | Battery type .......................................................................................... 14M20_1/4 | heat | HI ................................................................................................. 6M20_2/4 | humidity | HI not Aquaris ........................................................................ 6M20_3/4 | microwave | HI ....................................................................................... 6M20_4/4 | X‑Ray | HI .............................................................................................. 6M23 | wireless interference ..................................................................................... 8M28, M213 | environmental pollution .................................................................... 18M29 | recycle HI .................................................................................................... 18M31_1/3 | tube with ear piece ............................................................................... 12M35 | choking | pediatric ....................................................................................... 13M38_1/2 | autophone | interference ...................................................................... 10M38_2/2 | autophone | life support ....................................................................... 10M48_1/3 | cable with ear piece ............................................................................. 12M78a | more than 132 dB ..................................................................................... 16M90 | only tted | HI ................................................................................................ 4M91 | interference ................................................................................................... 8M102 | magnet in HI ............................................................................................. 11M105_2/2 | tinnitus D8 und D9 ............................................................................... 9M106_1/2 | tinnitus dispenser ............................................................................... 16M107 | directionality ................................................................................................ 5M108 | app acouic control signal ....................................................................... 15M109 | damaged device | HI ................................................................................... 4M110 | unauthorized modications ......................................................................... 5M111 | contraindications dispenser (replaces M106_2/2) ab RA V29 .................... 7M112 | contraindications user (replaces M105_1/2) ab D9 .................................... 7
Document No. 03341-99T##-#### ##Order/Item No. ### ### ##Master Rev01, 07.2017© ##.2017, Sivantos GmbH. All rights reserved 0123This document applies to hearing instruments manufactured by Sivantos GmbH and by Signia GmbH.

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