Cochlear Baha Bedienungsanleitung Seite 6

Additional instructions essential to safe
use in the MR environment:
• Under the scan conditions defined above, the
BIM400 Implant Magnet is expected to produce
a maximum temperature rise of 2.1 ° C after 15
minutes of continuous scanning.
• In non-clinical testing, the BIM400 Implant
Magnet produced a temperature rise of less than
2.1 ° C (extrapolated) at a maximum whole body
averaged specific absorption rate (SAR) of 2.0
W/kg (extrapolated) assessed by calorimetry for
15 minutes of MR scanning in a 1.5 Tesla Intera,
Philips Medical Systems (Software: 12.6.1.3,
2010-12-02) MR Scanner.
• In non-clinical gradient-induced heating testing,
the BIM400 Implant Magnet produced a
temperature rise (extrapolated) of less than 4.5
° C at a time rate of change of the theoretical
maximum worst-case gradient magnetic field
dB/dt (extrapolated) of 200 T/s during 30 min.
of continuous exposure in a test laboratory
system (Pulsed Magnetic Field Generator)
equivalent with a gradient system of a 1.5 Tesla
MR system.
• In non-clinical testing with the implant magnet
in place, the image artefact caused by the device
extends approximately 11.5 cm (4.5 in.) from
the BIM400 Implant Magnet when imaged with
a gradient echo pulse sequence and a 1.5 Tesla
MRI system.
6
Other Safety Information
• Remove the sound processor and SP Magnet
for any treatment involving ionizing radiation,
such as for example X-ray, CT-scan and radiation
therapy.
• The implanted magnet may affect diagnostic
information/treatment effectiveness in the area
around the magnet during a treatment with
ionizing radiation (e.g. X-Ray, CTscan, radiation
therapy). Consult your treating physician before
going through any such treatment.
• The Baha Attract System contains small parts
that may be hazardous if swallowed or may
cause choking if ingested or inhaled.
• The Baha Attract System contains magnets
that should be kept away from life supporting
devices, e.g. cardiac pacemakers and ICDs
(implantable cardioverter defibrillators) and
magnetic ventricular shunts, as the magnets may
affect the function of these devices. Contact the
manufacturer of the specific device to find out
more.
• The Baha Attract System (SP Magnet and
implanted magnet) contains magnets that may
interfere with or damage surrounding electronic
devices, for example mobile phones.
• If the SP magnet is too weak the sound
processor may fall off. If it is too strong you
may feel discomfort or experience soreness and
irritation of the skin. If you are unsure about
the strength of your SP magnet, contact your
hearing care professional.