En - English; C7601 C7601Ea; C7602Ea; C7602 - Integra CUSA Clarity Instrucciones De Uso

EN – ENGLISH
Introduction
A sterile, disposable torque wrench is available for use with
the 23kHz and 36kHz CUSA ® Clarity handpieces (C7023,
C7036) and sterilizable torque bases (C7623, C7636):
Description
C7601 23kHz Torque Wrench (Multipack)
C7601EA 23kHz Torque Wrench (Single Pack)

C7602

36kHz Torque Wrench (Multipack)

C7602EA

36kHz Torque Wrench (Single pack)
All catalog numbers may not be available in all regions
of the world.
Intended Use
The CUSA® Clarity 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.
For Use With
All 23kHz Tips
C7601
C7023 23kHz Handpiece
All 36kHz Tips
C7602
C7036 36kHz Handpiece

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 law (US) restricts
this device to sale by or on the order
of a licensed healthcare practitioner
Not made with natural rubber latex
Sterilized using ethylene oxide
Manufacturer
Date of Manufacture
Follow Instructions for Use
Operating Temperature:
+10oC to +35oC
Transport and Storage Temperature:
-18oC to +60oC
Color
Gray Ring
Red Ring
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
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
Catalog Number
Lot Number
Do Not Re-Use
Do Not Resterilize
Use By (YYYY-MM-DD)
Do Not Use if Package is Damaged
MR Unsafe
Keep Dry
Operating Humidity:
30% to 85%
Transport and Storage Humidity:
15% to 85%
Atmospheric Pressure
500hPa to 1060hPa
Supplied sterile. The torque wrench
is for single patient use only.
Refer to the CUSA Clarity Ultrasonic Surgical
Aspirator System Operator's Manual for full
MR Safety information.