Instructions For Use - Integra MAYFIELD A1108 Instruction Manual

ENGLISH
Description
The MAYFIELD® Triad Skull Clamp (REF A-1108) is designed
to give rigid skeletal fixation, allow the surgeon more
freedom in positioning the fixation pins and show
indication of pin force. Avoidance of critical areas of the
skull is made possible by a swiveling rocker arm, which
rotates 360 degrees, making application much easier.
The swivel rocker arm can rotate 360 degrees under full
skeletal pressure after pin impingement, making final
patient positioning safer and easier.
The MAYFIELD Skull Clamp requires the use of three (3)
each MAYFIELD Skull Pins.
MAYFIELD Skull Pins
MAYFIELD Reusable Adult Skull Pin - (REF A-1047)
MAYFIELD Reusable Child Skull Pin - (REF A-1048)
MAYFIELD Disposable Adult Skull Pins -
(REF A-1072 - Plastic)
MAYFIELD Disposable Adult Skull Pins -
(REF A-1083 - Steel)
MAYFIELD Disposable Child Skull Pins -
(REF A-1084 - Steel)
The MAYFIELD Ultra Base Unit (REF A-2101) and MAYFIELD
Ball Socket Swivel Adaptor (REF A-1064), MAYFIELD Swivel
Adaptor (REF A-1018), or MAYFIELD Tri-Star Adapter (REF
A-2008) are required when using the MAYFIELD Skull
Clamp. In addition, the MAYFIELD Crossbar Adaptor (REF
A-1015) is required for use of the skull clamp for the sitting
position.
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:
Non-Mayfield branded products used with
MAYFIELD products - We caution that we
have only validated MAYFIELD products used
in conjunction with the MAYFIELD product line, and as
a result, cannot advise you whether suppliers' products
would work properly with the MAYFIELD line of products.
WARNING:
This device is not intended for use in or near
the vicinity of a strong magnetic field. (MRI)
WARNING:
Do not alter the design of the device in part or
whole as serious patient injury could result.
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.

Instructions for Use

1. Mounting of MAYFIELD Skull Pins
NOTE:
Use only MAYFIELD brand skull pins with this skull clamp.
Seat pins so there is no gap
between the shoulder of the
pin and the face of the socket
CAUTION:
Carefully inspect reusable skull pins before
each use. To maintain proper fixation, pins
should be of equal length. Damaged (dull, bent, etc.) pins
should be replaced. It is recommended that spare pins
always be kept available.
WARNING:
Never attempt to resharpen skull pins. Dull or
bent pins should be replaced.
NOTE:
When using MAYFIELD Skull Pins follow Instructions For
Use supplied with the product.
WARNING:
Skull pins are not recommended for use
on children under five (5) years of age and
extreme caution should be exercised in pediatric cases
because of the thin skull. MAYFIELD Child Skull Pins are
recommended for young children over the age of five (5)
years. It is at the discretion of the user, when the adult or
child skull pins should be used.
2. Fixation to Patient
WARNING:
Failure to properly position patient and to fully
tighten and secure all adjustable portions of
this or any similar device may restult in skull pin slippage
and serious patient injury, such as scalp laceration, skull
fracture or even death.
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