Integra MAYFIELD A1059 Instruction Manual page 6

ENGLISH
Indications for Use/Intended Purpose/
Description
The Modified MAYFIELD® Skull Clamp (REF A-1059)
is designed to give rigid skeletal fixation and allow
the surgeon more freedom in positioning the
fixation pins. 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 Modified 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
the MAYFIELD Ball Socket Swivel Adaptor (REF
A-1064), the MAYFIELD Swivel Adaptor (REF A-1018),
or the MAYFIELD Tri-Star Adapter (REF A-2008) are
required when using the Modified MAYFIELD Skull
Clamp. In addition, the MAYFIELD Crossbar Adaptor
(REF A-1015) is required for use of the skull clamp for
the sitting position.
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:
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.
a. Push skull pins as far as possible into pin holder
receptacles on skull clamp.
CAUTION:
Inspect reusable skull pins before each
use. To maintain proper fixation, pins
should be of equal length. Broken, dull,
or bent pins should be replaced. It is recommended
that spare pins always be kept available.