DePuy Mitek Mini QUICKANCHOR Plus, Manual

Page: 5 / 96

5
Anchors before reviewing instructions for use and
rehearsing the installation procedure in a skills laboratory.
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, wholebody-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°C was observed during testing
(parameters listed below).
Parameters:
• Maximum MR system-reported, wholebody-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.
INSTRUCTIONS FOR USE
1. Prepare the bone hole site using the sterile drill bit
provided in the package. Proper drill hole size is
2.0mm x 9.7mm. Minimum hole spacing is 5mm. Bone
stock must be adequate to allow proper placement.
WARNING: MOVING THE POWER DRILL UNIT OFF
THE AXIS OF THE HOLE WHILE DRILLING MAY
CAUSE THE DRILL TIP TO BREAK.