Integra MAYFIELD Horseshoe Headrest Instruction Manual page 6

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ENGLISH
Indications for Use/Intended Purpose/Description
The MAYFIELD® Swivel Horseshoe Headrest A-1011 and
A-1012 are designed for the prone and supine positions.
The MAYFIELD Ultra Base Unit (REF A-2101) and the
MAYFIELD Ball Socket Swivel Adaptor (REF A-1064)
are required when using the A-1012 MAYFIELD Swivel
Horseshoe Headrest. No swivel adaptor is required for
the A-1011 MAYFIELD Horseshoe Headrest. This system
permits both lateral and vertical mobility for positioning
the patient's head. Replacement Gel Pads (REF 4-1-C-1444,
Left; or 4-1-C-1445, Right) are available individually.
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 serious patient injury.
WARNING:
This device is not intended for use in or near the
vicinity of a strong magnetic field. (MRI)
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.
Make certain to securely attach the base unit to the
operating room table.
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. Mount MAYFIELD Base Unit on to Operating Room
Table
2. Attach Swivel Adaptor to Transitional Member of Base
Unit (for A-1012); Attach A-1011 Horseshoe Headrest to
Transitional Member of Base Unit
a. Insert the small ratchet torque screw on Adaptor
or A-1011 Horseshoe Headrest into threaded hole
on Transitional Member.
b. Turn the torque knob of the Adaptor or A-1011
Horseshoe Headrest clockwise, tightening fully.
CAUTION:
Before fully tightening, always be certain that the
starburst teeth of the Swivel Adaptor and other
starburst fittings are the same size and properly mesh.
Failure to do so may damage fittings. Figure 3 shows a
typical starburstconnection and proper meshing of teeth.
3. Mount Headrest on Adaptor (for A-1012)
a. Insert torque screw of large ratchet into threaded
hole on Headrest.
b. Turn torque knob clockwise several turns.
c. Position Headrest and tighten knob fully by
turning clockwise. Be sure the two sets of sunburst
teeth mesh properly (Figure 3).
4. Adjust Headrest Pulley Rod
Pulley rod can be positioned for traction, released and
dropped out of the way, or removed.
a. To loosen, turn pulley rod torque knob counter-
clockwise.
b. Turn torque knob clockwise to fully tighten. Be
sure the two sets of sunburst teeth mesh properly.
5. Adjust Faceplates
a. Turn torque knob counter-clockwise to loosen
until the faceplates are moveable.
b. Position faceplates to accommodate head size.
c. Fully tighten torque knob by turning clockwise.
Instructions for Use - Gel Pad Attachment
1. Attach the Gel Pads onto the Horseshoe Faceplates
as follows (Figure 4 depicts attachment of Gel Pad to
Stationary Faceplate):
• Slide the Gel Pad onto the Faceplate arm between tabs
A and B until the end of the Gel Pad stops at the end of
the Faceplate arm.
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