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•
Automated cleaning in a washer disinfector with lid on to
contain implant components
•
Dry
Avoid impact, scratching, bending or surface contact with
any materials that might affect the implant surface or
configuration.
Special attention shall be paid to recesses since both
chemicals and rinse water may be entrapped in them.
Implants previously implanted must
not be re-used.
MAGNETIC RESONANCE (MR)
COMPATIBILITY
Polymeric Implants:
Non-clinical testing has demonstrated the BENGAL,
COUGAR, LEOPARD, and CONCORDE Carbon-Fiber
Composite VBR System implants are MR Conditional.
A patient with these devices can be safely scanned in an
MR system meeting the following conditions:
•
Static magnetic field of 1.5T and 3.0T with quadrature
driven coil
•
Maximum spatial field gradient of 1,900 gauss/cm
(19.0 T/m)
•
Maximum MR system reported, whole body averaged
specific absorption rate (SAR) of 2 W/kg (Normal
Operating Mode)
Under the scan conditions defined above, the BENGAL,
COUGAR, LEOPARD, and CONCORDE Carbon-Fiber
Composite VBR System implants are expected to produce
a maximum temperature rise of less than 3.6°C after
15 minutes of continuous scanning.
In non-clinical testing, the image artifact caused by these
devices extends approximately 6mm from the implant when
imaged with a gradient echo pulse sequence and a 3.0T
MRI system.
Metallic Implants:
Non-clinical testing has demonstrated the BENGAL
Stackable, OCELOT, DEVEX Mesh and X-MESH implants
are MR Conditional. A patient with these devices can be
safely scanned in an MR system meeting the following
conditions:
•
Static magnetic field of 1.5T and 3.0T with quadrature
driven coil
•
Maximum spatial field gradient of 1,900 gauss/cm
(19.0 T/m)
•
Maximum MR system reported, whole body averaged
specific absorption rate (SAR) of 2 W/kg (Normal
Operating Mode)
Under the scan conditions defined above, the BENGAL
Stackable, OCELOT, DEVEX Mesh and X-MESH implants
are expected to produce a maximum temperature rise of
less than 5.0°C after 15 minutes of continuous scanning.
In non-clinical testing, the image artifact caused by these
devices extends approximately 47mm from the implant when
imaged with a gradient echo pulse sequence and a 3.0T
MRI system.
The Surgical Titanium Mesh implants have not been tested
for safety and compatibility in the MR environment. The
devices have not been tested for heating or migration in the
MR environment. Scanning a patient who has this device
may result in patient injury. The risks associated with other
passive implants in an MR environment have been
evaluated and are known to include heating, migration, and
image artifacts at or near the implant site.
The surgeon must be thoroughly knowledgeable not only
in the medical and surgical aspects of surgical implants,
but must also be aware of the mechanical and metallurgical
limitations of metallic surgical implants.
VBR Spinal System components should not be used with
components of spinal systems from other manufacturers.
LIMITED WARRANTY AND DISCLAIMER
PRODUCTS FROM DEPUY SYNTHES PRODUCTS, INC.
ARE SOLD WITH A LIMITED WARRANTY TO THE
ORIGINAL PURCHASER AGAINST DEFECTS IN
WORKMANSHIP AND MATERIALS. ANY OTHER EXPRESS
OR IMPLIED WARRANTIES, INCLUDING WARRANTIES OF
MERCHANTABILITY OR FITNESS, ARE HEREBY
DISCLAIMED.
IF MORE THAN TWO YEARS HAVE ELAPSED BETWEEN
THE DATE OF ISSUE/REVISION OF THIS INSERT AND
THE DATE OF CONSULTATION, CONTACT DEPUY
SYNTHES SPINE FOR CURRENT INFORMATION AT
+1-800-365-6633 OR AT +1-508-880-8100.
