Intended Users - Integra CUSA Clarity Mode D'emploi

EN – ENGLISH
23 kHz Handpiece
Contents
1
Handpiece Cable with Connector
Handpiece Connecting Body
2
3
Handpiece Body
4 Aspiration Port
36 kHz Handpiece
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.
All catalog numbers may not be available in all regions
of the world.
Description
C7023 Handpiece
C7036
Handpiece
Intended Use
The CUSA Clarity handpiece is intended for use
with the CUSA Clarity Ultrasonic Surgical Aspirator
®
System. Refer to the CUSA Clarity Ultrasonic Surgical
Aspirator System Operator's Manual for indications,
contraindications, and warnings.
1
4
3
1
3
Frequency
23kHz
36kHz

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
2
2
WARNING
No modification of this equipment is allowed.
WARNING
When the handpiece is connected to a CUSA Clarity
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.
2
Product complies with the
requirements of directive 93/42/EEC
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
Operating Temperature:
+10oC to +35oC
Transport and Storage Temperature:
-18oC 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
Atmospheric Pressure:
500hPa to 1060hPa