Integra CUSA Clarity Instructions For Use

2
EN
–
ENGLISH
Introduction
The Sterile Bone Tip is available for use with the
23 kHz CUSA
®
Clarity handpiece (C7023):
Description Diameter
C7420SEA Bone Tip 2.78 mm
C7420S Bone Tip 2.78 mm
WARNING
The CUSA
®
Clarity Bone Tip is intended to
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
0086
0123
Product complies with the
requirements of directive 93/42/EEC
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
STERILE EO
Sterilized using ethylene oxide
Manufacturer
Date of Manufacture
Follow Instructions for Use
Operating Temperature:
+10C to +35C
Transport and Storage Temperature:
-18C to +60C
Catalog Number
Lot Number
Do Not Re-Use
STERILIZE
2
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%
Non-pyrogenic
Atmospheric Pressure:
500hPa to 1060hPa
WARNING
CUSA
®
Clarity 23 kHz CEM
™
Nosecone is not permied for
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
1
2
4
3
1
1 Tip
2
1 Nosecone
3
1 Flue
4
1 Stylet
Contents

Integra CUSA Clarity Specifications

General

Brand	Integra
Model	CUSA Clarity
Category	Medical Equipment
Language	English