Integra CUSA Clarity Instructions For Use

3
EN
–
ENGLISH
WARNING
To avoid injury or damage to equipment, place system
in standby prior to changing tip or clearing a clog.
WARNING
Potential burn hazard - CUSA Clarity tips utilize a silicone
flue. Compressing the flue against the side of the vibrating
surface along the length of the tip may cause excessive
heating, which may burn the adjacent tissue of the
surgical site.
WARNING
Excessive loading of CUSA Clarity tips at the surgical
site may induce heating due to vibration and acoustic
power transmissions. Thermal management of the
surgical site with the aid of the appropriate irrigation
and aspiration seings is essential.
WARNING
Avoid excessive lateral loading of CUSA Clarity tips.
This may result in injury to the patient and/or user,
or equipment damage.
WARNING
Irrigation and aspiration seings must be balanced
to allow for sufficient cooling of each tip's abrasive
surface. Irrigation to each tip's abrasive surface should
be maximized to avoid excessive heating.
WARNING
When testing the handpiece, do not allow the tip to
come in contact with any person or object during tip
activation. Contact may result in injury to the patient
and/or user, or handpiece tip damage.
Contact with anything may cause the test to fail.
WARNING
Do not power up the handpiece without performing
a prime cycle (that is, irrigation fluid must flow from the
distal tip of the handpiece). Failure to prime the handpiece
could result in permanent damage to the handpiece
(internal and/or external components) and may induce
heat exchange with the patient and/or user, and cause
tissue burns.
WARNING
To ensure sterility, assemble sterile handpiece and
tip in the sterile field only.
Sterilization Information
Supplied sterile. All items in this pack are for single
patient use only. Sterile tips may be resterilized one
time if unused. Steam sterilize only. Refer to the CUSA
Clarity Ultrasonic Surgical Aspirator System Operator’s
Manual for the steam sterilization parameters.
For this procedure, use the sterile, disposable 23 kHz
torque wrench (C7601) and the sterilizable 23 kHz
torque base (C7623).
MR Safety Information
Refer to the CUSA Clarity Ultrasonic Surgical
Aspirator System Operator’s Manual for full
MR Safety information.
Disposal of the Tips
The CUSA Clarity tip must be disposed of in accordance
with regional regulation hospital protocols.
WARNING
Single-use devices are for single patient use only.
Do not reprocess or re-use. Tips break during re-use.
Duty Cycle
Under maximum loading conditions, the CUSA
®
Clarity
console is suitable for ultrasonics activation times
of 10 minutes on, 5 minutes off.
Recommended Seing
For bone fragmentation, recommended seings are
100% amplitude and a minimum irrigation rate of 10
mL/ min.
Assembling the Handpiece in the Sterile Field
NOTE:
For information about changing tips in the sterile field,
refer to the “Changing Tips in the Sterile Field During
a Surgical Procedure” section CUSA Clarity Ultrasonic
Surgical Aspirator System Operator’s Manual.
NOTE:
Retain stylet in sterile field to address clogging issues.
Do not use stylet without puing system into stand-by
mode.
WARNING
The handpiece and handpiece accessories (tip, flue,
stylet, and nosecone) must be sterile before surgical
use. Before use, sterilize the torque base in the sterilizer
tray with the handpiece.
Aaching a Tip
1. Thread a tip onto the handpiece connecting body
by turning the tip clockwise until it is finger tight.
Place the torque base on a flat surface or in the
designated spot in the sterilization tray.
WARNING
Before use, sterilize the torque base in the sterilization
tray with the handpiece.

Integra CUSA Clarity Specifications

General

Brand	Integra
Model	CUSA Clarity
Category	Medical Equipment
Language	English