En - English; Intended Users - Integra CUSA Clarity Instrucciones De Uso

EN – ENGLISH
4
Contents
1
Handpiece Cable with Connector
Handpiece Connecting Body
2
3 Handpiece Body
4 Aspiration Port
Introduction
The CUSA Clarity handpiece is a hand-held surgical
®
device with a tip that is applied to patient tissue during
surgical procedures.
Description
C7036 Handpiece
Intended Use
The CUSA Clarity handpiece is intended for use
with the CUSA Clarity Ultrasonic Surgical Aspirator
®
System. Refer to the CUSA
Aspirator System Operator's Manual for indications,
contraindications, and warnings.

Intended Users

The intended users of this Instructions for Use (IFU)
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.
Symbols Used on Labeling
Product complies with the
requirements of directive 93/42/EEC
0086
CAUTION: Federal (USA) law restricts
this device to sale by or on the order
of a physician
Manufacturer
Date of Manufacture
Follow Instructions for Use
1
3
Frequency
36kHz
Clarity Ultrasonic Surgical
®
2
WARNING
No modification of this equipment is allowed.
WARNING
When the handpiece is connected to a CUSA
System that is powered on, but the handpiece is not in
use, keep the handpiece away from the patient. Place
the handpiece on a sterile, flat, dry, nonconductive, and
highly visible surface.
WARNING
When the handpiece is powered on, contact of the tip
with a hard surface (for example: a metal instrument,
tray, staples, clips, instruments, and so on) may damage
the tip of the handpiece.
WARNING
Do not use a damaged handpiece with the CUSA Clarity
System. This may result in injury to the patient or user.
WARNING
Touching the tip of the handpiece by the user, while the
handpiece is powered on, may result in personal injury.
WARNING
The minimum aspiration level setting is 10%. This
ensures proper handpiece cooling and performance.
Insufficient aspiration may cause premature handpiece
or tip failures and may induce heat exchange with the
patient or user, and cause tissue burns.
2
Operating Temperature:
+10oC to +35oC
Transport and Storage Temperature:
-20oC to +60oC
Catalog Number
Serial Number
MR Unsafe
CAUTION, Consult accompanying
documents
Keep Dry
Operating Humidity:
30% to 85%
Transport and Storage Humidity:
15% to 85%
Waste Electrical and Electronic
Equipment
This product is not made with natural
rubber latex
Clarity
®