Integra MAYFIELD A1051 Instruction Manual page 6

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ENGLISH
Indications for Use/Intended Purpose/
Description
The MAYFIELD® Pediatric Horseshoe Headrest
(REF A-1051) is designed for the prone and supine
positions. The MAYFIELD Ultra Base Unit (REF
A-2101) is required when using the MAYFIELD
Pediatric Horseshoe Headrest. This system permits
both lateral and vertical mobility for positioning the
patient's head.
Replacement Gel Pads (REF 4-40-C-1011, Left; or
4-40-C-1012, Right) are available individually.
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.
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.
Instructions for Use
1. Mount MAYFIELD Base Unit on to Operating
Room Table
2. Mount Headrest on Base Unit
a. Insert Headrest torque screw into threaded
hole on Transitional Member.
b. Turn Headrest torque screw clockwise several
turns.
c. Position Headrest and tighten knob fully by
turning clockwise (Figure 4)
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 starburst connection and proper
meshing of teeth.
3. Adjust Faceplates
a. Turn Torque knob counter-clockwise until the
faceplates are movable.
b. Position faceplates to accommodate head
size.
c. Fully tighten torque knob by turning
clockwise.
Instructions for Use - Gel Pad Attachment
Attach the Gel Pads onto the Horseshoe Faceplates
as follows (Figure 5 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.
• Pull tab C over the top edge of the Faceplate arm
to lock into place.
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