Safety manual for hearing instruments
Content Safety information Intended use Explanation of symbols General warnings BTE or RIC or custom models For infants, small children and mentally disabled persons When using remote control apps For Hearing Care Professionals 3 3 3 4 11 Important information Transport and storage conditions Disposal information Conformance information 17 17 17 17 2 13 15 16 Content
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. 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 warnings WARNING Risk of impairing the residual hearing of the user.
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). WARNING Choking hazard! Your hearing instruments contain small parts which can be swallowed. XX Keep hearing instruments, batteries and accessories out of reach of children and mentally disabled persons.
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. XX Turn the hearing instruments off when not in use to preserve the battery. XX Remove batteries when the instruments are not in use for a prolonged period of time. NOTICE XX Protect your hearing instruments from extreme heat. Do not expose them to direct sunlight.
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 tinnitus noiser function Your 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. WARNING Risk 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. XX The tinnitus noiser 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. 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.
BTE or RIC or custom models 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 infants, small children and mentally disabled persons There are special hearing instruments for the fitting of infants and small children. 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. XX Check the completeness of the hearing instruments regularly.
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 Tinnitus noiser function The 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. WARNING Risk of further impairment to the user’s hearing health.
Important information Transport and storage conditions During extended periods of transport and storage, please observe the following conditions: Storage Transport Temperature 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 XX Recycle hearing instruments, accessories and packaging according to local regulations.
Conformance information Europe: With the CE marking Siemens confirms compliance with the European Directive 93/42/EEC concerning medical devices. Australia: Supplier code number N14203 Wireless functionality Europe: For the products with wireless functionality Siemens confirms compliance with the European Directive 99/5/EC (R&TTE)concerning radio and telecommunications terminal equipment. USA and Canada Technical details Operating frequency: fc = 3.
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.
Legal Manufacturer Siemens Audiologische Technik GmbH Gebbertstrasse 125 91058 Erlangen Germany Phone +49 9131 308 0 Document No. A91SAT-02379-99T01-7600 EN Order/Item No. 108 268 32 | Master Rev01, 06.2014 © Siemens AG, 07.2014 www.siemens.
