Integra MAYFIELD A2101, Instruction Manual

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EN – English
4
Indications for Use/Intended Purpose/
Description
The MAYFIELD® Ultra Base Unit (REF A2101 or A2102) is designed
for patient positioning in the prone, supine, and sitting positions.
The MAYFIELD Ultra Base Unit can be easily readjusted to fit most
operating tables. It is used in conjunction with the MAYFIELD Ball
Socket Swivel Adaptor (REF A1064), the MAYFIELD Swivel Adaptor
(REF A1018), or the MAYFIELD Tri-Star Adapter (REF A2008) for
attachment of various MAYFIELD Neurosurgical Headrests and Skull
Clamps. The MAYFIELD Crossbar Adaptor (REF A1015 or A1016) and
the MAYFIELD Universal Side Rail Fitting (REF A1060) are required
for the sitting position.
The End Brackets of the MAYFIELD Ultra Base Unit are equipped
with internal isolation caps to help provide insulation against stray
electrical current.
NOTE:
The MAYFIELD Neurogen Adaptor (REF A1113) may be required for
those operating tables not designed to accept the MAYFIELD Ultra
Base Unit. (REF A2101 or A2102). The MAYFIELD Ultra Base Unit (Fig.
1), is supplied with an Adjustment Wrench (REF 41A1284), and a 6”
Transitional Member (REF 41B1171).
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 skull pin slippage and serious
patient injury, such as scalp lacerations, skull fracture, or
even death.
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.
WARNING:
This device is not intended for use in or near the vicinity of
a strong magnetic field. (MRI)
CAUTION:
The MAYFIELD Ultra Base Unit must never be stored in the
locked position without a transitional member in its receptacle
(Fig. 2). Failure to do so may result in damage to the equipment.
NOTE:
It is important to periodically adjust the tension of the Locking
Lever to compensate for changes which occur with normal usage.
Care and Handling
1. Release Locking Lever by pulling upward (Fig. 1).
2. Remove the Adjustment Wrench from its receptacle on the right
End Bracket by turning counter-clockwise.
3. Insert the Adjustment Wrench into the Lock Screw located at the
center of the Tension Knob at the base of the Base Handle (Fig. 3).
Turn the Adjustment Wrench counterclockwise several turns in
order to unlock the Tension Knob.
4. Turn the Tension Knob counter-clockwise to loosen tension or
clockwise to tighten tension on the Locking Lever.
5. Test the tension on the Locking Lever by depressing and releasing
the Lever. Movement should be smooth, but firm.
6. Test stability by placing the Base Unit on top of the O.R. Table.
In the unlocked position place the Base Handle and Transitional
Member in a straight line of 45° to the table and depress the
Locking Lever (Fig. 4). Exert pressure in a downward direction on
the Transitional Member. No movement should be observed.
7. Re-lock the Tension Knob by turning the Adjustment Wrench
clockwise within the Lock Screw (Fig. 3).Return the Adjustment
Wrench to its receptacle.
NOTE:
Over a period of time, the Shock Cushion within the Base Handle
may become deformed (Fig. 2). Deformation of the Shock Cushion,
visible just below the Locking Lever, is normal and will not affect
the operation of the Base Unit. However, deformation of the Shock
Cushion in the interior of the receptacle will prevent insertion or
ease of movement of the Transitional Member in the receptacle.
To prevent this type of deformation, always store the MAYFIELD
Ultra Base Unit with a Transitional Member in its receptacle and the
Locking Lever depressed (Fig. 2).
Directions for Use
1. Align the two End Brackets of the MAYFIELD Ultra Base Unit with
the receptacles at the head end of the operating table.
NOTE:
The MAYFIELD Ultra Base Unit is equipped with an adjustable left
End Bracket which may be repositioned as needed.
2. Remove Adjustment Wrench from its receptacle by turning
counter-clockwise.
3. Insert the Adjustment Wrench into the Adjustment Screw located
on the left End Bracket (Fig. 1).
4. Turn Adjustment Wrench counter-clockwise one full turn so
left End Bracket slides smoothly on the Connecting Tube to the
required position.
5. Insert End Bracket into the O.R. table’s receptacles and turn the
receptacle fastening screws until fully tightened.