Integra MAYFIELD Instruction Manual page 5

ENGLISH
Indications for Use/Intended Purpose/
Description
The MAYFIELD® Infinity Support System is a headrest
support device that attaches to any MAYFIELD Base
Unit Support Rods (A2101 or older models), creating a
method for simultaneous application of a Headrest (adult,
pediatric, or general purpose) and a Skull Clamp (ages 5+).
Figure 1
The MAYFIELD Infinity Support System (Figure 1) includes:
A. Infinity Support Coupler
419B1010
B. Horseshoe - Pediatric
419A1030
C. Horseshoe - Adult
419A1031
D. Horseshoe - General Purpose
419A1050
E. Mini Gel Pad
438A1037
F. Storage Case (not pictured)
419A1060
NOTE:
All components are available as a system, or may be
purchased separately.
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.
1 each
1 each
1 each
1 each
2 each
1 each
WARNING:
This device is not intended for use in or near the
vicinity of a strong magnetic field. (MRI)
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.
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:
Before using this product, carefully read the
Instruction Manual for correct usage and
warnings associated with any other desired support
equipment.
Instructions for use:
Mount the Coupler to the MAYFIELD Base Unit and
O.R. Table
1. Loosen the Post screws on each of the Coupler posts
(Figure 2).
2. Slide the two rods of the MAYFIELD Base Unit into each
receptacle of the Infinity Support before inserting into
the O.R. Table Receptacles (Figure 3). Adjust the width
of the Coupler posts as necessary.
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EN – ENGLISH