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size and mesh properly. Failure to do so may damage
fittings. (Figure 4 shows typical sunburst connection and
proper meshing of teeth).
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.
Make certain to securely attach the base unit to the
operating room table.
Service Notes
1. A routine check made well before each case will
help avoid problems. The check should include the
following:
Check the plunger locking the ratchet arm in place for
movement as follows:
a. Remove the ratchet arm and hold the body with the
release mechanism pointed toward the floor.
b. Apply pressure upward while looking for movement.
If the release mechanism moves 1.6mm or more, the
unit should be returned for service.
2. While rotating the rocker arm 360 degrees lock and
unlock the index knob. To ensure proper locking
engagement, the knob must always turn a minimum
of 60 degrees. If it does not lock, a slight additional
rotation of the rocker arm should allow the locking
mechanism to engage. If difficulties are encountered,
the unit should be returned for service.
3. With the skull pin removed from the 80 psi torque
screw, apply as much force as possible over the hole
and check for movement of the index shaft. If rubber
protrudes from around the shaft, the unit should be
returned for service.
Cleaning and Sterilization
DO NOT STEAM STERILIZE !
Plastic components may be damaged by heat.
Manual Wash
CAUTIONS
•
Alkaline and highly acidic detergents and solutions
cause damage to the devices.
•
Channels and crevices found on this device require
particular attention during cleaning.
•
Pay special attention to the water quality used
throughout reprocessing. Hard water can damage
the surface of the equipment. Avoid using hard water.
Instead use purified water unless otherwise specified.
Limitations on reprocessing
•
Repeated processing has minimal effects on these
devices. Product life is normally determined by wear
and damage due to use.
•
It is important to have Integra NeuroSpecialists
perform routine inspections (twice yearly is
recommended). See contact information below.
INSTRUCTIONS
Containment/Transportation
•
Follow health care facility protocol for safe
containment and transport to the decontamination
environment.
•
It is recommended that devices are cleaned
immediately after use.
Preparation for Cleaning
•
Disassembly is required.
Disassembling Equipment Inspecting for Cleanliness
Take the ratchet arm out
of the skull clamp base
by releasing the plunger
knob. It is also possible to
unscrew all three pin
carriers. Keep lock knob in
unlocked position.
Pay close attention for
organic debris in the
channel on the skull
clamp base, hole passing
through the starburst, pin
carriers, and lock knob.
Cleaning – Manual Equipment: Water, Neutral pH Deter-
gent, Soft Bristle Brush, Towels
Method
1. Prepare neutral pH enzymatic detergent solution (e.g.
Endozime® AW Triple Plus with APA (Ruhof), 1:128 ratio)
according to detergent manufacturer’s instructions
using lukewarm tap water.
2. Prepare equipment for soaking by disassembling
removable parts and loosening connections.
3. Rinse equipment in warm water before placing into
bath.
4. Completely soak equipment in water/detergent
solution for 30 minutes maximum.
5. Clean thoroughly with a soft nylon bristle brush.
NOTE
– If possible, use a disposable brush.
6. Rinse in warm purified water until all visible substances
and residual detergent are removed.
NOTE
– Make sure
to give special attention to hard-to-reach areas.
7. Thoroughly dry equipment with soft clean towels
and use medically compressed air if needed, to dry
channels, crevices and lumens.
8. Inspect the equipment to make sure there is no visible
organic debris or residue from cleaning agent.
Repeat process if any soil is detected.
