Safety manual for hearing instruments for US and Canadian markets | Master DRAFT 2017-04-11
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 4 12 13 14 15 16 Important information Transport and storage conditions Disposal information Conformance information 17 17 18 18 For US and Canadian markets only For prospective hearing instrument users For hearing instrum
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".
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. in mining areas).
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 expose them to direct sunlight. NOTICE XX Do not dry your hearing instruments in the microwave oven. NOTICE Different types of strong radiation, e. g. during X-ray or MRI head examinations, may damage hearing instruments.
Contraindications 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.
For hearing instruments with a tinnitus feature Your hearing instrument 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. WARNING Risk of further impairment to the user’s hearing health.
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. For example, the safe distance between pacemaker and magnet should be at least 10 cm (4 inches). NOTICE Magnets can disturb electrical devices and delete stored data. XX Keep magnets away from computers, monitors, television sets, storage media and other electronic equipment/devices.
For hearing instruments with a magnet in the battery compartment WARNING Risk of interference with active and non-active implants! If you wear an active or a non-active implant, e.g. a brain implant: XX Prior to use, have the electromagnetic compatibility verified. Consult the physician that implanted the device before using your hearing instruments. XX Keep a safe distance of about 1.6 inches (4 cm) between the implant and hearing instruments.
For certain instrument types BTE models Instruments that are worn behind the ear and that have a tube. CAUTION Risk of injury! X Always wear the tube with an ear piece. X Make sure that the ear piece is completely attached. 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.
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 Transport and storage conditions During extended periods of transport and storage, please observe the following conditions: For hearing instruments with built-in power cells (lithium‑ion rechargeable batteries) Read the 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.
The ACMA compliance mark indicates conformity with the electromagnetic interference standards set by the Australian Communications and Media Authority (ACMA). Devices with the FCC marking comply with the standards of the FCC regarding electromagnetic interference (only for products with wireless functionality).
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.
For body worn operation, this device has been tested 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.
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.
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.
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. Battery tips If a battery is accidentially swallowed, seek medical attention immediately, or call the National Battery Hotline collect at (202) 625‑3333.
➎ ➏ xxxx/xx R 56 16X01234 xxxx / xx 16X0123456R ➊➋ ➌ ➎ ➊ ➏ ➍ XXXXX/XXX 16X123456R ➋➌ ➎ ➍ ➊ 16: year manufactured ➋ X: facility code where instrument was manufactured ➌ Serial number ➏ ➍ L or R: left or right ear instrument ➎ Manufacturer/Distributor ➊ XXXXX XX 16X123456R Model ➍ ➏ ➋ ➌ 25 DRAFT 2017-04-11
For BTE and RIC instruments, the year of manufacture is derived from the second digit: Code (second digit) Year D, E, F 2013 G, H 2014 L, M 2015 N, P 2016 Q, R 2017 S, T 2018 Please note the warranty is based upon the date of purchase, not the date of manufacture. Your Audiologist or Hearing Care Professional can answer any questions you may have about the identifying code on your hearing instrument.
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.
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.
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, RF emissions Subpart C U.S. FCC requirements for intentional radiators.
Standard Test Type Note EN 300 328 Signal integrity Wideband transmission and emissions 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.
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. ■ A Cyclic Redundancy Check (CRC) to check data validity. ■ A convolutional encoder/decoder (Viterbi) to correct errors.
Prescription Use Only U.S. federal law restricts this device to sale by or on the order of a doctor or Hearing Care Professional licensed to dispense hearing instruments in your state. 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 fit the device to your personal needs and requirements. This should include its use in a prescribed tinnitus treatment program.
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. The target population is primarily the adult population over 21 years of age. The tinnitus feature is targeted for healthcare professionals treating patients suffering from tinnitus, as well as conventional hearing disorders.
Professional and are specific 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 adjustment as well as his or her comfort level and sound of the signal with their Hearing Care Professional.
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.
Your hearing instruments may have additional loss and damage coverage. Please consult your Hearing Care Professional to determine if this is applicable to your hearing instruments.
Risk mitigations (for internal use only) IFU101 | interference induction cooker | device....................................6 M11 | explosion | HI...............................................................................5 M15 | choking | non-ped HI...................................................................5 M18_2/2 | Battery type.........................................................................14 M20_1/4 | heat | HI.........................................................................
This document applies to hearing instruments manufactured by Sivantos GmbH and by Signia GmbH. Document No. 02421-99T##-#### ## Order/Item No. ### ### ## Master Rev08, 04.2017 © Sivantos GmbH, ##.
