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

EN – ENGLISH
Introduction
A sterile, disposable torque wrench is available for use with
the 36 kHz CUSA® Clarity handpiece (C7036) and sterilizable
torque base (C7636):
Description
Torque Wrench (Multipack)
C7602
C7602EA
Torque Wrench (Single pack)
Intended Use
The CUSA® Clarity 36 kHz Torque Wrench 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.

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
This product is not made with natural
rubber latex
Sterilized using ethylene oxide
STERILE EO
Manufacturer
Date of Manufacture
Follow Instructions for Use
Operating Temperature:
+10oC to +35oC
Transport and Storage Temperature:
-20oC to +60oC
Catalog Number
Lot Number
Do Not Re-Use
2
Do Not Resterilize
STERILIZE
Expiration Date
Do Not Use if Package is Damaged
MR Unsafe
Keep Dry
Operatng Humidity:
30% to 85%
Transport and Storage Humidity:
15% to 85%
Warnings for the Torque Wrench
WARNING
The torque wrench must not be brought into the MRI
environment. It is MR Unsafe.
WARNING
Do not use the sterile torque wrench for more than
one surgical procedure. Reprocessing may damage the
torque wrench.
WARNING
Single-use devices are for single patient use only. Do
not reprocess or re-use.
Sterilization Information
Supplied sterile. The torque wrench is
2
for single patient use only.
STERILIZE
MR Safety Information
Refer to the CUSA
Aspirator System Operator's Manual for full
MR Safety information.
Disposal of the Torque Wrench
The CUSA® Clarity torque wrench must be disposed
of in accordance with regional regulation hospital
protocols.
2
Clarity Ultrasonic Surgical
®