Integra MAYFIELD A1115 Manual De Instrucciones página 6

EN – ENGLISH
WARNING:
Do not alter the design of the device in part or whole as serious patient injury could
result.
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.
Make certain to securely attach the base unit to the operating room table.
WARNING:
If the Modified Swivel Adaptor Torque Screw becomes tight before the starburst
is properly meshed, the knob is incorrectly adjusted for this skull clamp. Use a
5/64" hex wrench to turn the adjustment screw counter clockwise four full turns to reset
the screw. See Illustration 1 for adjustment screw location. If the starburst fails to mesh
correctly after the screw is reset, the Modified Swivel Adaptor may be incompatible with
this particular clamp. See Section 2 for details.
WARNING:
The Modified Swivel Adaptor may be incompatible with earlier skull clamps made
with a two piece base design. See Section 2 to recognize incompatible conditions.
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.
Adjustment
Before its first use, the Modified Swivel Adaptor should be adjusted to ensure optimal
performance with your specific skull clamp.
1. Obtain the skull clamp with which the swivel adaptor will be used and position the
ratchet extension to approximately half its travel. See Illustration 2:
7-8"
Illustration 2
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