Integra MAYFIELD Swivel Adaptor Instruction Manual page 6

EN – ENGLISH
WARNING:
Failure to read and follow instructions
furnished in this product insert may result in skull
pin slippage and serious patient injury, such as scalp
lacerations, skull fracture, or even death.
WARNING:
Failure to properly position patient and to
fully tighten and secure all adjustable portions of
this or any similar device may result in skull pin
slippage and serious patient injury, such as scalp
laceration, skull fracture, or even death.
WARNING:
Do not alter the design of the device in part
or whole as serious patient injury could result.
WARNING:
This device is not intended for use in or near
the vicinity of a strong magnetic field. (MRI)
Make certain to securely attach the base unit to the
operating room table.
Intended Population
MAYFIELD Skull Clamp fixation devices are not
recommended for use on children under five (5)
years of age. Extreme caution should be exercised in
pediatric cases because of the thin skull.
Instructions for Use
1. Mount the MAYFIELD Base Unit with Transitional
Member on to operating room table.
2. Attach MAYFIELD Swivel Adaptor to Transitional
Member of Base Unit.
a. Insert small ratchet Torque Screw (Figure 1)
on Adaptor into threaded hole of Transitional
Member (Figure 2).
Transitional member
Figure 2
b. Turn Torque Screw clockwise to fully tighten.
CAUTION:
Before fully tightening, always be certain that
the starburst teeth of the Swivel Adaptor and other
starburst fittings are the same size and properly
mesh. Failure to do so may damage fittings. Figure
3 shows a typical starburst connection and proper
meshing of teeth.
c. The Swivel Adaptor will no longer swivel as it
is now in the locked position.
3. Mount Headrest on Swivel Adaptor.
a. Insert large ratchet Torque Screw ( Figure 1)
into the threaded hole on the MAYFIELD Skull
Clamp or appropriate headrest.
b. Turn Torque Screw clockwise a few turns.
c. Position headrest and tighten Torque Screw
fully by turning clockwise until tight. Be sure
the two sets of sunburst teeth mesh properly.
4. Rotation of Swivel Adaptor.
a. Loosen the Torque Screw ( Figure 1 ) and turn
counterclockwise to UNLOCK the Adaptor.
CAUTION:
Care should be taken to stabilize the patient's
head and headrest while the Swivel Adaptor is being
unlocked and repositioned.
b. Rotate the Swivel Adaptor until desired
position is obtained.
c. Again, tighten the small ratchet Torque Screw
applying as much pressure as possible. The
Adaptor should now be in the locked position
(Figure 4).
6
Figure 3