Daim Ntawv Qhia Tus Neeg Siv

8 Cochlear™ MRI Kit User Guide © Cochlear Limited, 2022 9
Intended users
The Cochlear MRI Kit is intended for use by specialised healthcare
professionals who prepare recipients for MR scans. The healthcare
professional applying the MRI Kit is Ear, Nose and Throat (ENT) Physicians.
Intended patient population
The Cochlear MRI Kit is intended to be used on an individual
requiring an MR scan at 1.5 T and who is implanted with a compatible
Cochlear Osia implant. There are no restrictions for the intended patient
population in terms of age, weight, health or other condition.
Clinical benefits
Benefits include enabling an MR scan at 1.5 T without the need to surgically
remove the magnet.
Serious incidents
Serious incidents are rare. Any serious incident in relation to your device
should be reported to your Cochlear representative and to the medical
device authority in your country, if available.
Obtaining an MRI Kit
Contact the nearest Cochlear office or official distributor to order an
MRI Kit.
MRI Kit contents
The following items are provided in your MRI Kit:
Item Description
Round Splint x 2
Round magnetic splints – to be placed on the
skin over each implant magnet site.
For bilateral patients, use one splint for each
implant.
Chinstrap x 2
• Size Large
• Size Small
Bandage x 1
Compression bandage – to provide compression
on each splint at the implant magnet site.
The Cochlear MRI Kit User Guide is supplied along with the Cochlear MRI Kit
for instructions on how to apply the chinstrap, splint and bandage.