Johnson & Johnson DePuy Synthes Mitek Tibial Guide, Manual

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INSTRUCTIONS FOR USE
Assemble the Tibial Guide System. Lock the Guide
Arm onto the Guide Rail at the desired angle. Position
the guide on the tibia. Push the Guide Bullet into place.
The Guide Bullet will ratchet into place when the word
“Locked” on the Guide Bullet aligns with the arrow on the
Guide Rail. To remove the Guide Bullet, rotate the Guide
bullet 180 degrees so the word “Locked” faces away from
the arrow on the Guide Rail and pull the Guide Bullet out
of the Guide Rail.
TIBIAL GUIDE ASSEMBLY AND DISASSEMBLY
INSTRUCTIONS
Assembly and Disassemble per the graphic provided on
the IFU.
INSTRUMENT CLEANING AND STERILIZATION
INSTRUCTIONS
CLEANING AND STERILIZATION INSTRUCTIONS
These cleaning and sterilization instructions have been
validated for preparing reusable Mitek instruments for
reuse. It is the responsibility of the end user to ensure
that the cleaning and sterilization is actually performed
using appropriate equipment, materials, and personnel
to achieve the desired result. This normally requires
validation and routine monitoring of the process. Any
deviation from these instructions should be evaluated
for effectiveness and potential adverse consequences.
PREPARATION
• Clean instruments as soon as possible after use. If
cleaning must be delayed, wet the instruments in
a compatible liquid solution to prevent drying and
encrustation of surgical soil.
• Avoid prolonged exposure to saline to minimize the
chance of corrosion.
• Remove excessive soil with a disposable wipe.
Prior to sterilization, instruments should be cleaned by
either automated or manual means described below.
AUTOMATED CLEANING
Instrument types with such complex design features as
cannulations, lumens, (i.e. tubes), holes, hinged joints,
box locks, spring-loaded retractable features, or flexible
shafts; must be manually pre-cleaned prior to automated
cleaning to improve the removal of adherent soil.
Manual Pre-Cleaning Instructions
• Flush internal areas with a warm detergent solution.
Pay close attention to lumens, cannulations,
holes, threads, crevices, seams, and any hard to
reach areas. While flushing, actuate any moveable
mechanisms (hinged joints, box locks, or spring-
loaded features) to free trapped blood and debris. If