Bellman & Symfon BE9124 Informationen Zu Medizinprodukten

BE9124 Earphones
EN
Medical device information
DE
Informationen zu Medizinprodukten
DK
Information om medicinsk udstyr
ES
Información sobre dispositivos médicos
FI
Lääketieteellisiä laitteita koskevat tiedot
FR
Informations sur les dispositifs médicaux
NL
Informatie over medische hulpmiddelen
NO
Informasjon om medisinsk utstyr
SE
Information om medicinteknisk utrustning
Medical device information
EN
Read this first
Thank you for choosing a product from Bellman & Symfon – the
world leader in listening systems based in Gothenburg, Sweden.
This leaflet contains important medical device information. Please read
it carefully to make sure that you understand and get the best out of
your Bellman & Symfon product. For more information about features
and benefits, contact your hearing care professional.
About the BE9124 Earphones
Intended purpose
The intended purpose of the audio product family is to amplify the
volume and improve the speech intelligibility during conversations and
TV-listening. It can also be used with other sound sources.
Intended user group
The intended user group consists of people of all ages experiencing
mild to severe hearing loss who need sound amplification in different
situations.
Intended user
The intended user is a person with mild to severe hearing loss who
needs sound amplification.
Principle of operation
The audio product family consists of several amplifiers and sound
transmitters which have been specifically developed to provide
sound enhancement even in demanding situations. Depending on
the assigned function of the specific amplifier or sound transmitter,
different microphones can be used to pick up direct sound or
enhance the ambient sound.
This device will not restore normal hearing and will not
prevent or improve a hearing impairment or deafness
resulting from organic conditions.
General warnings
This section contains important information about safety, handling
and operating conditions. Keep this leaflet for future use. If you are just
installing the device, this leaflet must be given to the householder.
Hazard warnings
 Failure to follow these safety instructions could result in fire,
electric shock, or other injury or damage to the device or other
property.
 Keep this device out of reach of children under 3 years.
 Do not use or store this device near any heat sources such as naked
flames, radiators, ovens or other devices that produce heat.
 Do not dismantle the device; there is a risk of electric shock. Tampering
with or dismantling the device will void warranty.
 This device is designed for indoor use only. Do not expose the
device to moisture.
 Protect the device from shocks during storage and transport.
 Protect cables from any potential source of damage.
 Do not make any changes or modifications to this device. Use
only original Bellman & Symfon accessories to avoid any electrical
shock.
 The connected listening device has a very powerful amplifier and the
sound level can cause discomfort or, in serious cases, endanger hearing
if the product is used carelessly. Always turn the volume down to a low
level before putting on the earphones!
Information on product safety
 Failure to follow these instructions could result in damage to the
device and void the warranty.
 Do not use the device in areas where electronic equipment
is prohibited.
 The device may only be repaired by an authorized service center.
 If you encounter other problems with your device, contact the
point of purchase, your local Bellman & Symfon office or the
manufacturer. Visit bellman.com for contact info.
 Do not drop your device. Dropping onto a hard surface can
damage it.
 If a serious incident occurs in relation to this device, contact the
manufacturer and relevant authority.
Operating conditions
Operate the device in a dry environment within the temperature
and humidity limits stated in this leaflet. If the device gets wet or is
exposed to moisture, it should no longer be regarded as reliable and
should therefore be replaced.
Cleaning
Disconnect all cables before you clean your device. Use a soft, lint-free
cloth. Avoid getting moisture in openings. Do not use household
cleaners, aerosol sprays, solvents, alcohol, ammonia or abrasives.
This device does not require sterilization.
Service and support
If the device appears to be damaged or doesn't function properly,
follow the instructions in the user guide and this leaflet. If the product
still doesn't function as intended, contact your local hearing care
professional for information on service and warranty.
Warranty conditions
Bellman & Symfon guarantees this product for six (6) months from
date of purchase against any defects that are due to faulty materials
or workmanship. This guarantee only applies to normal conditions
of use and service, and does not include damage resulting from
accident, neglect, misuse, unauthorized dismantling, or contamination
howsoever caused. This guarantee excludes incidental and
consequential damage. Furthermore, the warranty does not cover
Acts of God, such as fire, flood, hurricanes and tornadoes.
This warranty gives you specific legal rights and you may also have
other rights that vary with territory. Some countries or jurisdictions
do not allow the limitation or exclusion of incidental or consequential
damages, or limitations on how long an implied warranty lasts, so the
above limitation may not apply to you. This guarantee is in addition to
your statutory rights as a consumer. The above warranty may not be
altered except in writing signed by both parties hereto.
Regulatory symbols
With this symbol, Bellman & Symfon confirms that
the product meets the Medical Device Regulation
EU 2017/745.
This symbol indicates the manufacturer's serial number
so that a specific medical device can be identified.
It's available on the product and gift box.
This symbol indicates the manufacturer's catalogue
number so that the medical device can be identified.
It's available on the product and gift box.
This symbol indicates the medical device manufacturer,
as defined in EU Directives 90/385/EEC, 93/42/EEC and
98/79/EC.
This symbol indicates that the user should consult
this leaflet.
This symbol indicates that it is important for the user to pay
attention to the relevant warning notices in the user guides.
This symbol indicates important information for
handling and product safety.
Temperature during transport and storage:
–10° to 50° C, 14° – 122° F. Temperature during
operation: 0° to 35° C, 32° to 95° F
Humidity during transportation and storage:
<90%, non-condensing. Humidity during operation:
15% – 90%, non-condensing
Atmospheric pressure during operation,
transportation and storage: 700hpa - 1060hpa
This device is designed such that it functions without
Operating
conditions
problems or restrictions if used as intended, unless
otherwise noted in this leaflet.
With this CE symbol, Bellman & Symfon confirms
that the product meets EU standards for health,
safety, and environmental protection as well as the
Radio Equipment Directive 2014/53/EU.
This symbol indicates that the product shall not be
treated as household waste. Please hand over your old
or unused product to the applicable collection point for
the recycling of electrical and electronic equipment or
bring your old product to your hearing care professional
for appropriate disposal. By ensuring this product is
disposed of correctly, you will help prevent potential
negative effects on the environment and human health.
Technical specifications
Weight: 16 g, 0.5 oz
Frequency range: 20 Hz – 20 kHz
Impedance: 16 Ω +/- 10%
Sensitivity: 93 dB/mW @ 1 kHz
Colour: Black
Cable length: 1.25 meters
Connector: 3.5 mm stereo plug
In the box
BE9124 Earphones

Configuration options
These earphones can be configured with all of Bellman & Symfon' s
personal amplifiers and listening systems.
For detailed product information, see the corresponding
user manual.
Compliance information
Hereby Bellman & Symfon declares that, in Europe, this product is in
compliance with the essential requirements of the Medical Device
Regulation EU 2017/745 as well as the directives and regulations listed
below. The full text of the declaration of conformity can be obtained
from Bellman & Symfon or your local Bellman & Symfon representative.
Visit bellman.com for contact information.
Medical Device Regulation (MDR)
Radio Equipment Directive (RED)
EC General Product Safety Directive
Electromagnetic Compatibility Directive (EMC)
LVD Directive
Restriction of Hazardous Substances Directive (RoHS)
REACH Regulation
Waste Electrical & Electronic Equipment (WEEE)
EC Battery Directive
ISO Certification of legal manufacturer
Bellman is certified in accordance with SS-EN ISO 9001 and
SS-EN ISO 13485.
SS-EN ISO 9001 Certification Number: CN19/42071
SS-EN ISO 13485 Certification Number: CN19/42070
Certification Body
SGS United Kingdom Ltd
Rossmore Business Park Ellesmere Port Cheshire CH65 3EN UK