Integra MAYFIELD A1015, Инструкция по эксплуатации

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Indications for Use/Intended Purpose/
Description
The MAYFIELD® Crossbar Adaptor (REF A-1015 &
A-1016) is designed for procedures requiring sitting
positions, primarily the posterior fossa craniotomy and
the posterior cervical laminectomy when performed in
the sitting position.
The MAYFIELD Ultra Base Unit (REF A-2101), and the
MAYFIELD Ball Socket Swivel Adaptor (REF A-1064), the
MAYFIELD Swivel Adaptor (REF A-1018), or the MAYFIELD
Tri-Star Adapter (REF A-2008) are required when using the
MAYFIELD Crossbar Adaptor.
If the Operating Table is not equipped with its own side
rail fittings, then the MAYFIELD Universal Side Rail Fitting
(REF A-1060) will be required.
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)
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 Universal Side Rail Fittings to
Operating Room Table
a. Loosen the T-Handle by turning counter-clockwise
and slide onto the side rail making sure the
T-Handle is above the side rail (Figure 2).
b. Lock the T-Handle by turning clockwise.
c. Loosen the Locking Handle by turning counter-
clockwise, in order that the side rail receptacles are
completely open.
2. Mount Crossbar Adaptor to Side Rail Fittings
a. Loosen set screws on Crossbar by turning counter-
clockwise in order to adjust leg widths to that of
the Side Rail Fittings (Figure 5).
b. Holding the Crossbar’s Legs in each hand, insert
each one into the receptacles of the Side Rail
Fittings, adjusting the legs as necessary (Figure 1).
c. Tighten the Locking Handles of the Side Rail
Fittings locking the Crossbar in place.
d. Tighten the set screws on the Crossbar Adaptor by
turning clockwise.
3. Mount MAYFIELD Base Unit to the Crossbar Adaptor
a. Loosen the Crossbar’s Torque Screw Assembly
by turning counter-clockwise. The Crossbar
Receptacles should now be completely open.
b. Insert the Base Unit’s Mounting Bars into the
Crossbar Receptacles.
NOTE:
The Mounting Bars should point away from the patient
(Figure 3).
c. Tighten the Crossbar’s Torque Screws to secure the
Base Unit in place.
4. Attach Swivel Adaptor to Transitional Member of
Base Unit
a. Insert the small ratchet torque screw on Adaptor
into threaded hole on Transitional Member.
b. Turn the Adaptor torque knob clockwise to fully
tighten.
CAUTION:
Always be sure the two sets of sunburst teeth
mesh properly, (Figure 4) when knob is tightened.
Failure to do so may result in damage to the device.
This caution applies to any such fitting in the MAYFIELD
System.
WARNING:
When the patient is finally positioned, make sure
that all attachments are checked and properly
locked into position.