Stryker Core 5400-050-000 User Manual

5400-050-700 Rev-N EN
www.stryker.com 7
Safety Directives
WARNINGS:
• Before using this equipment, or any component compatible with this
equipment, read and understand the instructions for use. Pay particular
attention to safety information. Become familiar with the equipment before
use.
• Only individuals trained and experienced in the use of this medical device
should operate this equipment. Healthcare personnel should be thoroughly
familiar with the instructions for use, handling characteristics, and the
intended use(s) of this instrument. Contact your Stryker sales representative
or Customer Service for in-service training.
• The healthcare professional performing any procedure is responsible
for determining the appropriateness of this equipment and the specific
technique used for each patient. Stryker, as a manufacturer, does not
recommend surgical procedure or technique.
• Upon initial receipt and before each use, operate the equipment and inspect
each component for damage. DO NOT use any equipment if damage is
apparent or the inspection criteria are not met. See the Inspection, Testing,
and Maintenance section for inspection criteria.
• Upon initial receipt and before each use, clean the equipment as indicated.
See the Cleaning and Disinfection section for care information.
• DO NOT use this equipment in areas in which flammable anesthetics or
flammable agents are mixed with air, oxygen or nitrous oxide.
• Take special precautions regarding electromagnetic compatibility (EMC)
when using medical electrical equipment like the CORE console. Install and
place the console into service according to the EMC information contained
in this manual. Portable and mobile radio frequency (RF) communications
equipment can affect the function of the CORE console.
• To avoid the risk of electric shock, ALWAYS connect this equipment to a
hospital-grade, facility power receptacle with protective earth. DO NOT
modify the ground connection of the console power cord.
• DO NOT stack or place equipment adjacent to the CORE console if
possible. If such a configuration is necessary, carefully observe the
configuration in question to ensure that electromagnetic interference does
not degrade performance.
• ALWAYS follow the recommended duty cycle to prevent the equipment from
overheating. See the Specifications section and/or the instructions for use
supplied with the handpiece.
• ALWAYS operate the equipment within the specified environmental condition
values. See the Specifications section.
• All cutting accessories are intended for single use only. Reuse significantly
increases wear on the handpiece and attachment.
• All cutting accessories are intended for single use only. Reuse significantly
increases wear on the handpiece and attachment. DO NOT reuse,
reprocess, or repackage a device that is intended for single use only.
- A single use device may not withstand chemical, chemical vapor, or
high temperature sterilization reprocessing.
- Design features may make cleaning difficult.
- Reuse may create a contamination risk and compromise structural
integrity resulting in operational failure.
- Critical product information may be lost during repackaging.
Failure to comply may lead to infection or cross infection and result in
patient and/or healthcare staff injury.
• ALWAYS use the appropriate accessory combination with a handpiece.
Contact your Stryker sales representative for a complete list of accessories.
• DO NOT attempt to insert or remove any cutting accessory or attachment
while the handpiece is operating.
• DO NOT place a handpiece on a patient.
• 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.
• If power is lost, some of the console’s programmed settings, such as
the handpiece to footswitch assignment, the footswitch options, and the
handpiece operating modes, will revert to their original default configuration
or the last selected User Preference configuration. After power is restored,
reprogram the console settings as required.
• 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. Monitor the heat response in
relation to the type of surgical procedure being performed. Frequently
check the distal tip and body until you are familiar with its temperature rise
characteristics.
• Ensure the handpiece speed does not exceed the specified attachment
limitations.
• If operated for extended periods of time, a handpiece may exceed its
nominal operating temperature range. A console warning message will
appear when the nominal operating range is approached, and again when it
is exceeded. Allow the handpiece to cool before restarting.
• Use personal protective equipment (PPE).

Stryker Core 5400-050-000 Specifications

General

Brand	Stryker
Model	Core 5400-050-000
Category	Medical Equipment
Language	English