Sivantos WL003BTE BTE Hearing Aid User Manual English

Sivantos GmbH BTE Hearing Aid English

Contents

User Manual English

Safety manual for hearing instruments
2ContentContentSafety information  3Intended use  3Explanation of symbols  3General warnings  4BTE or RIC or custom models  11For infants, small children and mentally disabled persons  13When using remote control apps  15For Hearing Care Professionals  16Important information  17Transport and storage conditions  17Disposal information  17Conformance information  17
Safety information 3 This safety manual provides safety information and other important information about your hearing instruments. It covers several instrument types and optional features. XRefer to the user guide of your hearing instruments, to check the instrument type and the activated features. Intended useHearing instruments are intended to improve the hearing of hearing impaired persons. Diagnosis and prescription of a hearing instrument must be performed by hearing health specialists, e.g. acousticians, audiologists or ENT doctors.Use the hearing instruments 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 instruments. Safety information
Safety information4 Symbols 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 Australia.Do not dispose of the device with general domestic waste. Read more in section "Disposal information".Read and follow the instructions in the user guide. General warningsWARNING Risk of impairing the residual hearing of the user. XUse only hearing instruments 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.WARNING Note 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.
Safety information 5 WARNINGYour hearing instruments may reduce certain background sounds, potentially also trafc or warning signals.WARNINGRisk of explosion! XDo not use your hearing instruments in explosive atmospheres (e. g. in mining areas).WARNINGChoking hazard!Your hearing instruments contain small parts which can be swallowed. XKeep hearing instruments, 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 instruments that are intended for the tting of infants, small children, or mentally disabled persons, refer also to section "For infants, small children and mentally disabled persons".NOTICE XProtect your hearing instruments from high humidity. Do not wear them in the shower or when you apply make-up, perfume, aftershave, hairspray or suntan lotion.
Safety information6 NOTICEOnly 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 instruments. XTurn the hearing instruments off when not in use to preserve the battery. XRemove batteries when the instruments are not in use for a prolonged period of time.NOTICE XProtect your hearing instruments from extreme heat. Do not expose them to direct sunlight.NOTICE XDo not dry your hearing instruments in the microwave oven.NOTICEDifferent types of strong radiation, e. g. during X-ray or MRI head examinations, may damage hearing instruments. XDo not wear the hearing instruments during these or similar procedures.Weaker radiation, e. g. from radio equipment or airport security, does not damage the hearing instruments.
Safety information 7 ContraindicationsWARNINGConsult a Hearing Care Professional if you experience any unusual side effects 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 instrument user to consult a licensed physician before using the hearing instrument if the Hearing Care Professional determines that the prospective user has any of the following conditions: XVisible congenital or traumatic deformity of the ear. XHistory of active drainage from the ear within the previous 90 days. XHistory 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.
Safety information8 For hearing instruments with wireless functionalityIn some countries restrictions for the usage of wireless equipment exist. XRefer to local authorities for further information.WARNINGRisk of affecting electronic equipment! XIn areas where the use of electronics or wireless devices are restricted, verify if your device has to be turned off.NOTICEYour hearing instruments are designed to comply with international standards on electromagnetic compatibility but interference with nearby electronic devices could occur. In this case, move away from the source of interference.
Safety information 9 For hearing instruments with tinnitus noiser functionYour hearing instrument may be equipped with a tinnitus noiser. The use of the tinnitus noiser 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 noiser can be set to a level which could lead to permanent hearing damage when used for a prolonged period of time. XThe tinnitus noiser should never be used at uncomfortable levels.
Safety information10 For hearing instruments with AutoPhone magnetWARNINGRisk of affecting life support systems! XUse a magnet only when it is a safe distance away from life support systems, such as pacemakers or magnetic valves. For example, the safe distance between pacemaker and magnet should be at least 10 cm (4 inches).NOTICEMagnets can disturb electrical devices and delete stored data. XKeep magnets away from computers, monitors, television sets, storage media and other electronic equipment/devices.
Safety information 11 For hearing instruments 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 instruments. XKeep a safe distance of about 1.6 inches (4 cm) between the implant and hearing instruments.
Safety information12 BTE or RIC or custom models BTE modelsInstruments 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 instrument 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 instruments. Custom modelsThere is no additional safety information that applies for custom models only.
Safety information 13 For infants, small children and mentally disabled personsThere are special hearing instruments for the tting of infants and small children. Ask your Hearing Care Professional for further information.WARNINGChoking hazard!Your hearing instruments contain small parts which can be swallowed. XEnsure adequate supervision if infants, small children or mentally disabled persons need to wear hearing instruments. XCheck the completeness of the hearing instruments regularly. XEnsure that your child or the mentally disabled person does not detach the hearing instrument 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.
Safety information14 When using remote control appsWhen using an app for controlling hearing instruments:WARNINGRisk of hearing damage!The device with the app for controlling hearing instruments 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.
Safety information 15 For Hearing Care ProfessionalsTinnitus noiser functionThe 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 adjustment 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 noiser can be set to a level which could lead to permanent hearing damage when used for a prolonged period of time. XShould the tinnitus noiser be set to such a level in the hearing instrument, advise the user of the maximum amount of time per day he or she should use the tinnitus noiser. For example, occupational safety guidelines restrict continuous noise exposure of 80 dBA SPL to 8 hours per day. XThe tinnitus noiser should never be used at uncomfortable levels.
Important information16 Transport and storage conditionsDuring extended periods of transport and storage, 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.Disposal information XRecycle hearing instruments, accessories and packaging according to local regulations. 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.Important information
Important information 17 Conformance informationEurope: With the CE marking Siemens conrms compliance with the European Directive 93/42/EEC concerning medical devices.Australia: Supplier code number N14203Wireless functionalityEurope: For the products with wireless functionality Siemens conrms compliance with the European Directive 99/5/EC (R&TTE)concerning radio and telecommunications terminal equipment.USA and CanadaTechnical detailsOperating frequency: fc = 3.28 MHzUSA FCC ID: SGI-WL003BTECanada IC: 267AB-WL003BTEWireless platform model: e2e 3.0This 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 RSS-210 of Industry Canada.
Important information18 Operation is subject to the following conditions: ■this device may not cause harmful interference, and ■this device must accept any interference received, including interference that may cause undesired operation.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. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off 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 different from that to which the receiver is connected. ■Consult the dealer or an experienced radio/TV technician for help.
www.siemens.com /hearing Document No. A91SAT-02379-99T01-7600 ENOrder/Item No. 108 268 32 | Master Rev01, 06.2014© Siemens AG, 07.2014Legal ManufacturerSiemens Audiologische Technik GmbHGebbertstrasse 12591058 ErlangenGermanyPhone +49 9131 308 0

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