Safety manual for hearing instruments for US and Canadian markets Master
Content Safety information Intended use Explanation of symbols General warnings For certain instrument types For children under the age of 3 years For certain battery types When using remote control apps For Hearing Care Professionals 3 3 3 5 13 16 17 18 19 Important information Operating, transport and storage conditions Disposal information Conformance information 20 20 21 21 For US and Canadian markets only For prospective hearing instrument users For hear
Safety information This safety manual provides safety information and other important information about your hearing instruments. It covers several instrument types and optional features. X Refer to the user guide of your hearing instruments, to check the instrument type and the activated features. Intended use Hearing 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.
Symbols on the device or packaging CE compliance label, confirms compliance with certain European Directives, refer to section "Conformance information". EMC and radio communications compliance label Australia, refer to section "Conformance information". Optional symbol for custom models with wireless functionality. Indicates the legal manufacturer of the device. Do not dispose of the device with general domestic waste. Read more in section "Disposal information". Packaging can be recycled.
Symbols on the device or packaging Relative humidity during transportation. Read more in section "Operating, transport and storage conditions". Atmospheric pressure during transportation. Read more in section "Operating, transport and storage conditions". Medical device Compatible with Qi-certified wireless chargers. Bluetooth® low energy technology. General warnings WARNING Risk of impairing the residual hearing of the user. X Use only hearing instruments that have been fitted especially for your needs.
WARNING Note that any unauthorized changes to the product may cause damage to the product or cause injury. XX Use only approved parts and accessories. Ask your Hearing Care Professional for support. WARNING Your hearing instruments may reduce certain background sounds, potentially also traffic or warning signals. WARNING Risk of explosion! XX Do not use your hearing instruments in explosive atmospheres (e. g. mining areas).
If you have hearing instruments that are intended for the fitting 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". NOTICE XX Protect 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. NOTICE XX Protect your hearing instruments from extreme heat. Do not store them in direct sunlight.
NOTICE Your devices comply with international standards. However, it cannot be guaranteed that all products on the market work interference‑free, for example some induction cookers may cause audible interference. NOTICE In case of a serious incident, report the occurrence to the manufacturer of the device. NOTICE When not in use, please store your hearing instruments in the supplied jewel case or charging case (if applicable) and keep out of the reach of children.
WARNING Consult 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.
For hearing instruments with wireless functionality In some countries restrictions for the usage of wireless equipment exist. XX Refer to local authorities for further information. WARNING Risk of affecting electronic equipment! XX In areas where the use of electronics or wireless devices are restricted, verify if your device has to be turned off.
WARNING Risk 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. XX The tinnitus feature should never be used at uncomfortable levels. For hearing instruments with AutoPhone magnet WARNING Risk of affecting life support systems! XX Use a magnet only when it is a safe distance away from life support systems, such as pacemakers or magnetic valves.
NOTICE In close proximity, AutoPhone magnets can damage receiver units of RIC hearing instruments. XX Keep a minimum distance of 2 cm (0.8 inches) between the RIC receiver and any magnet, including the AutoPhone magnet. For example, do not store your RIC hearing instruments and a smartphone with attached AutoPhone magnet together in a small pocket or box.
For certain instrument types BTE models Instruments that are worn behind the ear and that have a tube. CAUTION Risk of injury! XX Always wear the tube with an ear piece. XX Make sure that the ear piece is completely attached. CAUTION Risk of injury! XX Insert the hearing instrument carefully and not too deeply into the ear. CAUTION Risk of injury! XX In very rare cases the ear piece could remain in your ear when removing the hearing instrument.
RIC models The receiver is placed within the ear canal and connected to the instrument via a receiver cable. CAUTION Risk of injury! X Always wear the receiver cable with an ear piece. X Make sure that the ear piece is completely attached. CAUTION Risk of injury! X Insert the hearing instrument carefully and not too deeply into the ear. CAUTION Risk of injury! X In very rare cases the ear piece could remain in your ear when removing the hearing instrument.
Instant fit models The hearing instrument is placed within the ear canal and kept in place with an ear piece. CAUTION Risk of injury! XX Always wear the hearing instrument with an ear piece. XX Make sure that the ear piece is completely attached. CAUTION Risk of injury! XX Insert the hearing instrument carefully and not too deeply into the ear. CAUTION Risk of injury! XX In very rare cases the ear piece could remain in your ear when removing the hearing instrument.
For children under the age of 3 years There are special hearing instruments for the fitting 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. WARNING Choking hazard! Your hearing instruments contain small parts which can be swallowed. XX Ensure adequate supervision if infants, small children or mentally disabled persons need to wear hearing instruments.
For certain battery types For hearing instruments with built-in power cells (lithium‑ion rechargeable batteries) Read the safety information on power cells in the hearing instrument's user guide. For hearing instruments with replaceable batteries NOTICE Only use zinc‑air batteries or nickel‑metal hydride (NiMH) rechargeable batteries. Do not use e.g. silver‑zinc or lithium‑ion rechargeable batteries. NOTICE Leaking batteries damage the hearing instruments.
When using remote control apps When using an app for controlling hearing instruments: WARNING Risk 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: XX Do not hold the loudspeaker of the device to your ears or the ears of others.
For Hearing Care Professionals WARNING For hearing instruments with an output sound pressure level of 132 dB SPL or more: Risk of impairing the residual hearing of the user. XX Take special care when fitting this instrument. Tinnitus feature The target population is primarily the adult population over 21 years of age.
Important information Operating, transport and storage conditions For hearing instruments with built-in power cells (lithium‑ion rechargeable batteries) Read the operating, transport and storage conditions in the hearing instrument's user guide.
Disposal information XX Recycle hearing instruments, accessories and packaging according to local regulations. For hearing instruments with replaceable batteries XX To avoid environmental pollution, do not throw batteries into household trash. XX Recycle or dispose of batteries according to local regulations or return them to your Hearing Care Professional.
Devices with the FCC marking comply with the standards of the FCC regarding electromagnetic interference (only for products with wireless functionality). Technical details If the certification information for USA and Canada is not listed in the hearing instruments’ user guide, the following certification numbers apply: ■ Wireless platform, model: e2e 3.0 ■ USA FCC ID: SGI-WL003BTE ■ Canada: 267AB-WL003BTE Notices 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. 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.
Data is stored inside the hearing instrument. This contains: ■ the audiogram, ■ the average daily wearing, ■ the frequency distribution of acoustic environments (i.e.
For US and Canadian markets only For prospective hearing instrument users Good 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 instrument. Licensed physicians who specialize in diseases of the ear are often referred to as otolaryngologists, otologists or otorhinolaryngologists.
If you have reservations about your ability to adapt to amplification, you should inquire about the availability of a trial‑rental or purchase‑option program. Many Hearing Care Professionals now offer programs that permit you to wear hearing instruments for a period of time for a nominal fee after which you may decide if you want to purchase them. U.S. federal law restricts the sale of hearing instruments to those individuals who have obtained a medical evaluation from a licensed physician. U.S.
Health considerations If soreness or skin irritation develops, discontinue wearing your hearing instruments, and bring the instruments and earmolds to your Hearing Care Professional. Minor fit adjustments or earmold modification can often correct this condition. If soreness persists, discontinue wearing the hearing instrument and see your physician. If excessive earwax accumulates when wearing your hearing instruments, consult your Hearing Care Professional.
➎ ➏ xxxx/xx R 56 18X01234 xxxx / xx 18X0123456R ➊➋ ➌ ➎ ➊ ➍ ➊ 18: year manufactured ➋ X: facility code where instrument was manufactured ➏ ➍ XXXXX/XXX 18X123456R ➌ Serial number ➋➌ ➎ ➍ L or R: left or right ear instrument ➏ ➎ Manufacturer/Distributor ➏ Model ➊ XXXXX XX 18X123456R ➍ ➋ ➌ 28
For BTE and RIC instruments, the year of manufacture is derived from the second digit: Code (first digit) Month Code (first digit) Month A, N Jan G, U Jul B, P Feb H, V Aug C, Q Mar J, W Sep D, R Apr K, X Oct E, S May L, Y Nov F, T Jun M, Z Dec Code (second digit) Year Code (second digit) Year B, C 2022 Q, R 2017 Y, A 2021 N, P 2016 W, X 2020 L, M 2015 U, V 2019 G, H 2014 S, T 2018 D, E, F 2013 Please note the warranty is based upon the date of purchase,
Wireless functionality The following tables summarizes the technical details of the wireless technology: Wireless technology Nearfield magnetic induction Antenna type Inductive antenna Antenna 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 mm Custom models: Ø: 3.3 mm, L: 4.2 mm, respectively, Ø: 2.0 mm, L: 6.7 mm Modulation PSK (Phase Shift Key) Magnetic field strength 0.
Data rate 324 kbit/sec (raw channel capacity) Data flow Simplex or semi-duplex capability Protocol Random access, no collision avoidance S.A.R. 2.36 nW/kg (BTE) 6.63 nW/kg (custom models) S.A.R. = Specific Absorption Rate (S.A.R.) based on 10 g ICNIRP testing. Bluetooth® low energy* Wireless technology Radio frequency Bluetooth low energy Antenna type Electromagnetic dipole antenna Antenna dimensions BTE or RIC models: H: approx. 4 mm, L: approx.
Bandwidth 2 MHz per channel Data rate 1 Mbit/sec, respectively, 2 Mbit/sec Data flow Simplex or semi-duplex capability Protocol Bluetooth network FHSS (Frequency Hopping Spread Spectrum) S.A.R. 1.31 nW/kg S.A.R. = Specific Absorption Rate (S.A.R.) based on 10 g ICNIRP testing. EMI/EMC compliance Wireless hearing instruments comply with the following EMC/EMI standards: Standard Test Type Note 47 CFR Part 15, Subpart C RF emissions U.S. FCC requirements for intentional radiators.
Standard Test Type Note EN 300 328 Signal integrity and emissions Wideband transmission systems; data transmission equipment operating in the 2.4 GHz ISM band and using wide band modulation techniques IEC 60118-13 RF immunity International product standard for hearing instruments to ensure adequate immunity to radio interference from mobile telephones. ANSI C63.
Standard Test Type Note ISO 14117 RF emissions Implantable medical device EMC immunity, International Standard. EN 45502-2-1 RF emissions Particular requirements for pacemakers. Wireless security measures Wireless signal security is assured through the device system design that includes: ■ A built-in pairing table which specifies valid and legitimate pairing among units. ■ A proprietary communication protocol which checks the package numbers during each transmission.
Tinnitus feature Your hearing instrument may be equipped with a tinnitus feature. Many tinnitus patients also suffer from some degree of hearing loss. Many hearing instruments can be used alone or in combination with the tinnitus feature. The tinnitus feature is fixed to a broadband noise that can be adjusted by your Hearing Care Professional for your tinnitus therapy. The feature may provide temporary relief of your tinnitus. Prescription Use Only U.S.
■ Chronic skin irritation on, near, or around the site of device placement. ■ Unusual side effects (e.g., dizziness, nausea, headaches, heart palpitations). ■ Perceived decrease in auditory function (e.g., decreased loudness, speech not as clear). For Hearing Care Professionals Indications for use The tinnitus feature is a tool to generate sounds to be used in a tinnitus management program to relieve patients suffering from tinnitus.
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 characteristics are adjustable by the Hearing Care Professional and are specific to the prescribed therapy designed by the professional for the patient’s needs and comfort.
For children with hearing loss In addition to seeing a physician for a medical evaluation, a child with a hearing loss should be directed to an audiologist for evaluation and rehabilitation since hearing loss may cause problems in language development and the educational and social growth of a child. An audiologist is qualified by training and experience to assist in the evaluation and rehabilitation of a child with a hearing loss.
Warranty and service Your hearing instrument, with the exception of the battery, is covered by a comprehensive warranty. All covered instrument 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 specifications for that model.
Risk mitigations (for internal use only) Data stored insde HI | content.............................................................24 FCC RF exposure | use with accessories...........................................23 IFU101 | interference induction cooker | device....................................8 M11 | explosion | HI...............................................................................6 M15 | choking | non-ped HI...................................................................
M110 | unauthorized modifications........................................................6 M111 | contraindications dispenser (replaces M106_2/2) ab RA V29...9 M112 | contraindications user (replaces M105_1/2) ab D9...................9 M136 | nickel exposure..........................................................................6 M138 | contraindication contact allergy.................................................8 M166 | store HI in case / HI............................................................
This document applies to hearing instruments manufactured by Sivantos GmbH and by Signia GmbH. This document applies to hearing instruments manufactured by WSAUD A/S. Document No. 03341-99T##-#### ## Order/Item No. ### ### ## Master Rev05, 12.2020 © ##.2020, WSAUD A/S.
