Integra Tri-Star MAYFIELD Manual De Instrucciones página 6

EN – ENGLISH
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.
Make certain to securely attach the base unit to the operating room table.
WARNING:
The Modified Tri-Star Swivel Adaptor may be incompatible with earlier models of skull clamps made with a two
piece base design. See Section 2 to recognize incompatible conditions.
WARNING:
If the swivel adapter knob 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 Tri-Star Modified Swivel Adapter may be incompatible with this particular clamp. See Section 2 for details
WARNING:
The adapter is optimized for use on that skull clamp to which it is adjusted. A single setting may be effective on
several skull clamps but it may also be over-adjusted for some other clamps.
During the preoperative equipment check, verify that the starburst teeth fully engage on the skull clamp that will be
used. It is important for patient safety to perform this inspection before the equipment is used for patient support.
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 Tri-Star 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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