Intended Users; Definition Of Symbols - Integra CUSA Excel Instrucciones De Uso

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Intended Use
Use the Tip Torquing Set to correctly assemble and
disassemble tips on the CUSA® Excel handpiece in
the nonsterile field.

Intended Users

The intended users of this guide and the
equipment it describes are qualified medical
professionals who are trained in the particular
surgical technique and surgical procedure to
be performed, and trained in the use of this
equipment.
Contents
1 Tip Torquing Base
1 Torque Wrench

Definition of Symbols

Symbol
N N
LOT
Sterilization Information
Do not sterilize. Supplied nonsterile for use in the
nonsterile field.
Refer to the CUSA Excel user manual for more
information.
Any serious incident that has occurred in relation
to the device for the user and/or the patient should
be reported to the manufacturer and the competent
authority of the member state in which the user and/
or patient is established.
2
Definition
Mandatory action: Read
instructions before use.
Operating Temperature:
+10oC to +35oC
Transport & Storage
Temperature: -34oC to
+ 65oC
Operating Humidity: +15%
to +80 %.
Transport & Storage
Humidity: +25% to +85%.
Keep Dry.
Do not use if package is
damaged.
Date of Manufacture.
Manufacturer.
Catalogue Number.
Batch Code.
Medical Device
Assembly
1. Thread the tip of choice onto the handpiece
connecting body. Turn the tip until it is finger
tight.
2. Locate the slot in the tip torquing base that
matches the color on the handpiece connector
(23 kHz – green; 36 kHz – blue). Put the
handpiece in the tip torquing base so that the
metal connecting body fits snugly in the metal
end of the slot.
3. Hold the handpiece in place in the tip torquing
base.
Notice
To avoid product damage, NEVER hold the
handpiece in your hand while using the torque
wrench to tighten or loosen the tip.
4. Match the colored end of the torque wrench with
the handpiece connector color. Slide the color
coded side of the wrench over the tip, being
careful not to damage the tip, until the hex in the
wrench engages the hex of the tip.
5. Rotate the wrench clockwise until you feel and
hear a click. Rotate again until you feel and hear a
second click.