Integra MAYFIELD 2 Manual De Instrucciones página 7

Indication For Use/Intended Purpose
The MAYFIELD 2 Skull Clamp is placed on the patient's skull to hold their head and neck securely in
a particular position when rigid fixation is desired. The Skull Clamp is indicated for use in open and
percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary.
The MAYFIELD 2 Skull Clamp is NOT Radiolucent.
Failure to read and follow instructions furnished in this product insert may result in skull pin slippage and
serious patient injury, such as lacerations, skull fracture, or even death.
The Skull Clamp must be applied along the center line of the patient's head with pins entering the skull
perpendicularly (See Table 1). Failure to properly position the Skull Clamp on the patient's head could re-
sult in patient injury such as scalp laceration due to skull pin slippage. Failure to properly position patient
and to fully secure all adjustment positions of the Skull Clamp or any support device may result in patient
injury.
It is cautioned that only MAYFIELD products have been validated for use with other MAYFIELD products.
Integra cannot advise whether other suppliers' products would function properly with the MAYFIELD
line of products. Integra does not offer warranty protection when a non-MAYFIELD brand product is used
with a MAYFIELD branded product.
Do not alter the design of the device in part or whole as serious patient injury could result.
Do not use Skull Clamps to exert excessive traction during a procedure. Patient injury could result.
Skull Clamps are not intended for use in or near the vicinity of a strong magnetic field (MRI).
This device is NOT Radiolucent.
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.
WARNING!
WARNING!
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