Integra CUSA Clarity Instructions For Use Manual page 2

EN – ENGLISH
1
4
Contents
1
1 Tip
2
1 Nosecone
3
1 Flue
4
1 Stylet
Introduction
The Sterile Bone Tip is available for use with the
23 kHz CUSA Clarity handpiece (C7023):
®
Description
C7420SEA Bone Tip
C7420S Bone Tip
WARNING
The CUSA
be used to remove bone and other calcified
tissue. Do not apply excessive lateral load
with these tips.
Intended Use
The CUSA Clarity Bone Tip 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. The tip is intended for
use with bone only.
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 (US) law restricts
this device to sale by or on the order
of a licensed healthcare practitioner
This product is not made with natural
rubber latex
Sterilized using ethylene oxide
STERILE EO
2
3
Diameter
2.78 mm
2.78 mm
Clarity Bone Tip is intended to
®
Manufacturer
Date of Manufacture
Follow Instructions for Use
Operating Temperature:
+10oC to +35oC
Transport and Storage Temperature:
-18oC to +60oC
Catalog Number
Lot Number
Do Not Re-Use
2
Do Not Resterilize
STERILIZE
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%
Non-pyrogenic
Atmospheric Pressure:
500hPa to 1060hPa
WARNING
CUSA Clarity 23 kHz CEM
®
use with Bone Tip.
WARNING
No modification of this equipment is allowed.
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
Touching the tip of the handpiece by the user, while the
handpiece is powered on, may result in personal injury
2
Nosecone is not permitted for
™