Integra MAYFIELD A1060 Manual De Instrucciones página 6

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Indications for Use/Intended Purpose/
Description
The MAYFIELD® Universal Side Rail Fitting (REF A-1060) is
designed for the attachment of the MAYFIELD Crossbar
Adaptor (REF A-1015 or A-1016), Garreston Overhead
Instrument Table (REF A-1053), and the Budde® Halo
Retractor Side Rail Support (REF A-1067) to the side rails
of the operating room table when the table's rail fittings
are not appropriate or present. Two (2) Side Rail Fittings
are required.
WARNING:
Failure to read and follow instructions furnished
in this product insert may result in serious patient injury.
WARNING:
Failure to properly position the patient and to
fully secure all adjustment portions of this or any support
device may result in serious patient injury.
WARNING:
Do not alter the design of the device in part or
whole as serious patient injury could result.
WARNING:
This device is not intended for use in or near the
vicinity of a strong magnetic field. (MRI)
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.
WARNING:
Failure to read and follow instructions furnished
in this product insert may result in serious injury.
Instructions for Use
1. Mount MAYFIELD Universal Side Rail Fittings to
Operating Room Table
a. Loosen the Hold Down Screw by turning counter-
clockwise ( Figure 1).
b. Slide the Side Rail Fittings onto the side rails of
the operating room table
NOTE:
Hold Down Screw should be above the plane of the
operating table's side rails.
c. Once the Side Rail Fitting has been slid into the
appropriate position on the side rails, tighten the
Hold Down Screws by turning clockwise.
WARNING:
Before using this product, carefully read the
product insert for correct usage and warnings associated
with the desired support equipment to be used with this
product.
CAUTION:
Make sure the Side Rail Fittings are properly
secured to the operating room table.
2. Mounting of Desired Support Equipment to the
MAYFIELD Universal Side Rail Fitting:
a. Loosen the Locking T-Handle by turning counter-
clockwise. This opens the Side Rail Receptacle to
accept the desired support equipment (Figure 2).
b. Insert the Support Posts from the above
mentioned support equipment into the Side Rail
Fitting's receptacles.
c. Tighten the Locking T-Handles on the Side Rail
Fittings to secure the Support Posts by turning
clockwise.
WARNING:
Failure to properly position patient and to fully
tighten all adjustment portions of this or any similar
device may result in serious patient injury.
Cleaning and Sterilization
After each use, thoroughly clean and wipe the unit with
an antiseptic solution.
DO NOT STEAM STERILIZE!
Plastic components may be damaged by heat.
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