User Manual

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Performing MRI safely
All external components of the Cochlear Osia
System (e.g. sound processors, and related
accessories) are MR Unsafe. The patient must
remove all external components of their system
before entering a room where an MRI scanner is
located.
Non-clinical testing has demonstrated that the
Osia OSI200 Implant, in combination with the
BI300 Implant, are MRI Conditional.
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Patients can
be scanned at 1.5 T with the magnet in place or
removed. Patients can be scanned at 3 T only if the
magnet has been removed.
A patient with these devices can be safely scanned
under the following conditions:
1.5 T scans
• Remove the sound processor before entering the
MRI scan room.
• The sound processor is MR Unsafe.
• Use the Cochlear Osia MRI Kit for MR scans
at 1.5 T with the implant magnet in place. For
instructions, see page 4.
• Static magnetic eld of 1.5 T.
• Maximum spatial eld gradient of 2000 gauss/cm
(20 T/m).
• When using a transmit/receive head coil, a
maximum MR system reported, head averaged
specic absorption rate (SAR) of 3.2 W/kg.
• When using a transmit body coil, a maximum MR
system reported, whole body averaged specic
absorption rate (SAR) of 2 W/kg.
In non-clinical testing, the maximum image artefact
caused by the OSI200 Implant when imaged with
a gradient echo pulse sequence scan in the axial
plane (Table 1).
With implant
magnet +
magnetic splint
With
non-magnetic
plug
Implant
magnet
removed
15.0 cm (5.9 in) 4.5 cm (1.8 in) 5.7 cm (2.2 in)
Table 1: Maximum image artefact from centre at
1.5T (gradient echo sequence).
The image artefact may extend further in the
coronal or sagittal plane.
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In non-clinical testing, the maximum image artefact
caused by the OSI200 Implant when imaged with
the SEMAC-VAT metal artefact reduction sequence
scan in the axial plane (Table 2).
With implant
magnet +
magnetic splint
With
non-magnetic
plug
Implant
magnet
removed
11.4 cm (4.5 in) 1.8 cm (0.7 in) 1.8 cm (0.7 in)
Table 2: Maximum image artefact from centre at
1.5T (SEMAC-VAT).
The image artefact may extend further in the
coronal or sagittal plane.
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Cochlear Osia MRI Kit
The Cochlear Osia MRI Kit is indicated for
CochlearOsia Implant recipients who require
an MRI scan at 1.5 T and have been assessed by
medical professionals as suitable for an MRI scan.
WARNING
To minimise possible pain and discomfort,
apply the splint and bandage immediately prior
to the entering the MRI room. Remove the
splint and bandage immediately after the MRI
procedure and the recipient is outside of the
MRI room.
If the splint becomes loose inside the MRI
room, this could lead to damage of the MRI
equipment and / or injury to the MRI sta or
recipient.
Do not conduct the MR scan if the splint does
not stay in place. Misalignment between the
splint and implant magnet may result in the
dislodgement of the implant magnet and could
cause pain.
Obtaining an MRI Kit
Contact the nearest Cochlear oce or ocial
distributor to order an MRI Kit.
The MRI Kit contains:
Fig. 1: Magnetic splints – to be placed against the
skin over the implant magnet site. For bilateral
patients use one splint for each implant.
Fig. 2: Compression bandage – for securing the
splint against the implant magnet site.
Fig. 3: User guide showing how to apply splints and
bandage