Indication For Use - Integra MAYFIELD Manual Del Instrucciones

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Indication For Use:

The MAYFIELD® Reusable Titanium Skull Pins (REF A1121, A1122) are
intended for use with a MAYFIELD skull clamp that is placed on the
patient's skull to hold their head and neck in a particular position
during surgical procedures where rigid skeletal fixation is desired and
intra-operative MR imaging is used.
The MAYFIELD Reusable Titanium Skull Pins (REF A1121, A1122) are
indicated for use in open and percutaneous craniotomies and spinal
surgeries when rigid skeletal fixation is necessary and when intra-
operative MR imaging of the patient is used.
Description
The MAYFIELD Reusable Titanium Skull Pins (REF A1121, A1122) are
used in conjunction with MAYFIELD brand Radiolucent Skull Clamps
(REF A1117, A2002 or A2006). The reusable skull pins are supplied
non-sterile and must be sterilized before each use.
The titanium pin will produce artifact similar to a steel pin if used
during X-Ray or CT imaging. Use MAYFIELD Radiolucent Skull pins
(A2020) to minimize artifact in X-Ray or CT modalities.
This device is MR Conditional* according to terminology specified in
the American Society for Testing and Materials (ASTM) International,
Designation: F2503-05.
*See Table 1 for conditions.
Non clinical testing demonstrated that the Reusable Titanium
Skull pin is "MR Conditional". A patient may be scanned under
these conditions:
Static Magnetic field Strength
Spatial gradient magnetic field
Maximum MR system reported whole-body-averaged specific
absorption rate (SAR): 3-W/kg for 15 min scan
In non clinical testing, the Reusable Skull Pin produced a
temperature rise of ≤ 0.4 °C at a maximum MR system reported
whole-body-averaged specific absorption rate (SAR) of 3-W/
kg for 15 minutes of scanning in a 3-Tesla MR system using a
transmit/receive body coil (Excite, Software G3.0-052B, General
Electric Healthcare, Milwaukee, WI)
MR image quality may be compromised if the area of interest
is in close proximity to the position of the Reusable Skull Pin.
Optimization of MR imaging parameters may be necessary.
Figure 1
Table 1
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English–EN
≤ 3.0 Tesla (T)
≤ 720-Gauss/cm