User's Manual

5
DRAFT
User/Patient Safety
WARNINGS:
• Before using any system component, or any component compatible with this system, read and understand the instructions. Pay
special attention to the important User/Patient Safety information provided in the instruction booklets. Familiarization with the
system prior to use is important. Failure to comply may result in patient and/or operating room staff injury or damage to
components.
• The surgeon performing any procedure is responsible to determine the appropriateness of this instrument and the specific
technique for each patient. Stryker, as a manufacturer, does not recommend surgical technique.
• Clean and sterilize components before first and every use. See the CORE Cleaning, Maintenance and Sterilization
Recommendations for specific details.
• DO NOT use this equipment in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide.
• Prior to each use, operate system components and inspect for damage. DO NOT use if damage is apparent.
• Use only Stryker approved accessories. Other accessories may not properly interface with the console. Contact your Stryker
sales representative for a complete list of accessories. DO NOT modify any accessory. Failure to comply may result in patient
and/or operating room staff injury.
• All cutting accessories are intended for single use only. Reuse significantly increases wear on the handpiece and attachment.
Failure to comply may result in patient and/or operating room staff injury.
• Always use the appropriate accessory combination with a handpiece. Contact your Stryker sales representative for a complete
list of accessories. Failure to comply may result in patient and/or operating room staff injury.
• DO NOT attempt to insert or remove any cutting accessory or attachment while the handpiece is operating. Failure to comply
may result in operating room staff injury.
• DO NOT modify the ground connection of the console power cord. Failure to comply may result in patient and/or operating room
staff injury.
• DO NOT place a handpiece on a patient. Failure to comply may result in patient injury, for example burns or damage to tissue.
• DO NOT place a handpiece on or near a magnetic pad or tray. A magnetic field can simulate the output of a handswitch or
footswitch and may cause the handpiece to operate inadvertently. Failure to comply may result in patient and/or operating room
staff injury.
• DO NOT perform footswitch mapping (assign a handpiece port to a footswitch port) while operating a handpiece. Failure to
comply may result in patient and/or operating room staff injury.
• Operating a handpiece in the Window Jog mode may increase the temperature of the handpiece. If a handpiece overheats, the
console automatically shuts off the handpiece. (The audible alarm does not warn the user if this event occurs.) Monitor the
operating time of the handpiece to prevent overheating. Failure to comply may result in patient and/or operating room staff injury.
• Use safety glasses. Failure to comply may result in operating room staff injury.
Contraindications
None.
Indications For Use
NOTE: If the console screen is touched in two places simultaneously, unintended button activation may result.
The Stryker Consolidated Operating Room Equipment (CORE) System is intended for use in the cutting, drilling, reaming,
decorticating, and smoothing of teeth, bone, bone cement, and other bone-related tissue in a variety of surgical procedures, including
but not limited to Neuro, ENT, Dental and Endoscopic. It is also usable in the placement or cutting of screws, metal, wires, pins, and
other fixation devices.