Integra MAYFIELD A-1064 Manual De Instrucciones página 5

ENGLISH
Indications for Use/Intended Purpose/
Description
The MAYFIELD® Ball Socket Swivel Adaptor (REF A-1064)
is designed to provide greater flexibility in positioning the
patient's head by allowing rotation in 360 degrees.
The MAYFIELD Ultra Base Unit (REF A-2101) with
its Transitional Member is required when using the
MAYFIELD Ball Socket Swivel Adaptor.
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.
Inspection
Always inspect instruments before and after use. If a
component appears damaged and/or does not seem to
function properly, do not use the device and immediately
send the instrument to an authorized Integra repair center
for evaluation, repair or replacement. Allow your Integra
Representative to inspect this device a minimum of two
times per year to assist you in its proper function.
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Figure 1
1. Retaining Rings
2. Torque Screw
3. Pivoting Base
4. Pivot Handle
5. Torque Screw
6. Pivoting Ball Sleeve
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.
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.
Make certain to securely attach the base unit to the
operating room table.
Instructions for Use
1. Mount the MAYFIELD Base Unit with Transitional
Member on to operating room table.
2. Attach MAYFIELD Ball Socket Swivel Adaptor to
Transitional Member of Base Unit.
a. Insert Torque Screw (#2 of Figure 1) on Adaptor into
b. Turn Torque Screw clockwise, tightening fully.
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2
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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. With Pivoting Base (#3 of Figure 1) in upright
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WARNING:
Failure to properly position patient and to fully
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)
threaded hole of Transitional Member (Figure 2).
Figure 2
CAUTION:
Before fully tightening, always be certain that the
starburst teeth of the Swivel Adaptor and other
position, the unit is locked by turning the Pivot
Handle (#4 of Figure 1) clockwise, applying as much
pressure as possible.
EN – ENGLISH