BUN264 ISS2 APR15
Cochlear Americas
13059 East Peakview Avenue
Centennial, CO 80111 USA
Telephone: 1 303 790 9010
Support: 1 800 483 3123
Cochlear Canada Inc.
2500-120 Adelaide Street West
Toronto, ON M5H 1T1 Canada
Telephone: 1 416 972 5082
Fax:
1 416 972 5083
www.Cochlear.com/US
©Cochlear Limited 2015. All rights reserved. Hear now. And always and other trademarks and registered
trademarks are the property of Cochlear Limited or Cochlear Bone Anchored Solutions AB. The names
of actual companies and products mentioned herein may be the trademarks of their respective owners.
Not everyone with hearing loss is a candidate for a Baha System. All surgical procedures
include an element of risk, and it is impossible to guarantee success. For complete
information regarding the risks and benefits of a Baha procedure, please refer to the
Instructions for use for the Baha implant available at www.Cochlear.com/US/BahaIndications
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
(see Fig. 2)
NOTE:
MR System manufacturers may claim that
scanning patients with implanted devices is generally
contraindicated. This is a general precautionary claim
due to the fact that MR System manufacturers are
unable to ensure safety for all types of implantable
devices. Cochlear has performed specific testing for
the above implants and established the necessary
SAR safety limits as outlined. Recently available MR
Systems are able to monitor SAR levels. The MR System
manufacturer should be able to provide advice on how
to maintain SAR levels with their system.
