User's Manual

6 www.stryker.com
EN 5400-052-700-EN Rev-D
7 Safety Directives
7.1 General Warnings
WARNINGS:
▪ ALWAYS be familiar with the Instructions For Use and
proper operation of this equipment before use. To
request in-service training, contact Stryker.
▪ ALWAYS consult the Instructions For Use that
accompanies motors, footswitches, and attachments
for product specific duty cycles and additional
information.
▪ Only healthcare professionals trained and experienced
in the use of this medical device should operate this
equipment.
▪ Healthcare professionals should be thoroughly familiar
with the Instructions For Use, handling characteristics,
and the indicated and intended uses of this equipment.
Contact Stryker 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.
▪ ALWAYS ensure the console is placed on a sturdy,
flat surface near a hospital-grade power outlet and all
connections (front and rear) are easily accessible.
▪ Upon initial receipt and before each use, ALWAYS
inspect equipment for damage. DO NOT use any
equipment if damage is apparent.
▪ ALWAYS clean and disinfect the equipment as
indicated upon initial receipt and before each use.
Failure to comply may cause infection and result in
patient and/or healthcare staff injury.
▪ ALWAYS consult the Instructions For Use that
accompanies motors, footswitches, and attachments
for product specific cleaning requirements.
▪ DO NOT touch the screen with any sharp or hard
object. Failure to comply may cause breakage and
result in healthcare staff and/or patient injury.
▪ DO NOT disassemble, modify, service, or repair this
equipment when using this equipment with a patient.
▪ DO NOT disassemble, modify, service, or repair
any equipment without the authorization of the
manufacturer. For assistance, contact Stryker.
▪ ALWAYS operate this equipment within the specified
environmental condition values (Appendix I:
Specifications).
▪ ALWAYS follow the recommended duty cycle to prevent
this equipment from overheating.
▪ DO NOT stack or place equipment adjacent to the
console. If such a configuration is necessary, observe
the configuration to ensure that electromagnetic
interference does not degrade performance.
▪ Take special precautions regarding electromagnetic
compatibility (EMC) when using medical electrical
equipment like the console. Portable and mobile radio
frequency (RF) communications equipment can affect
the function of the console.
▪ DO NOT use the console in an MRI environment.
Using the console in an MRI environment could affect
the function of the console.
▪ ALWAYS ensure footswitch placement is in a secure
area where inadvertent activation is not possible.
▪ ALWAYS select the correct irrigation flow rate based on
the surgical procedure and/or handpiece requirements
to prevent excessive or insufficient irrigation flow.
Failure to comply may limit the view of the surgical site
and result in patient and/or healthcare staff injury.
▪ ALWAYS select the correct attachment/reducer when
selecting the motor setting to prevent excessive or
insufficient motor speed. Failure to comply may cause
incorrect information to be displayed and result in
patient and/or healthcare staff injury.
▪ DO NOT place the console within the sterile field.
7.2 Electrical Warnings
WARNINGS:
▪ ALWAYS connect the console to a hospital-grade,
power outlet with protective earth (ground) to avoid the
risk of electrical shock.
▪ Electrical power is present when the console is
in standby mode. To completely remove power,
disconnect the power cord from either the console or
the hospital-grade, power outlet with protective earth
(ground) to avoid the risk of electrical shock.
▪ If power is lost, some of the console’s adjustable
settings, such as the motor to footswitch assignment,
footswitch options, and motor operating modes, will
revert to the default configuration or the last selected
preset. After power is restored, verify console settings.
0000221359, Rev. D Effective Date: Jun 1, 2017 10:00:55 AM
Print Date: Jun 08, 2017 08:54:46 AM