Johnson & Johnson DePuy Mitek GII QUICKANCHOR Plus, Manual

Page: 5 / 108

4
PRECAUTIONS
A surgeon should not attempt clinical use
of DePuy Mitek Anchors before reviewing
instructions for use and rehearsing the installation
procedure in a skills laboratory.
Moving the power drill unit off the axis of the hole
while drilling may cause the drill tip to break.
Do not twist or apply bending force to the inserter
as either may damage the anchor, suture or
inserter tip.
Do not attempt to remove QUICKANCHOR Plus
tip from drill hole until the slide cover is retracted
to the open position.
Magnetic Resonance Imaging (MRI)
Information
Non-clinical testing has demonstrated that
DePuy Mitek Metal Implants are MR Conditional .
A patient with a metallic implant can be scanned
safely under the following conditions.
3.0 Tesla Systems:
• Static magnetic field of 3.0 Tesla.
• Highest spatial gradient magnetic field of
720 Gauss/cm or less.
MRI Related Heating
• Maximum MR system reported, whole-body-
averaged specific absorption rate (SAR) of
2.9 W/kg for 15 minutes of scanning (i.e., per
pulse sequence).
MRI related heating was assessed for the
representative configurations of the Mitek metal
implants following guidelines provided in ASTM
F2182-02a. A maximum temperature change
equal to or less than 2.0 º C was observed during
testing (parameters listed below).
Parameters:
• Maximum MR system-reported, whole-body-
averaged SAR of 2.9 W/kg
• 15-minute duration MR scanning (i.e., per
pulse sequence).
• 3 Tesla MR System (EXCITE ® MR Scanner,
Software G3 .0-052B, General Electric
Healthcare, Milwaukee, WI) using a transmit/
receive RF body coil.
Artifact Information
MR Image quality may be compromised if the area
of interest is in the exact same area or relatively
close to the position of the Mitek metal implant.
Therefore, optimization of MR imaging parameters
to compensate for the presence of this device may
be necessary.