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Introduction
The CUSA® Clarity contamination guard is the filter and tubing
that connects between the canister and the CUSA® Clarity
Ultrasonic Surgical Aspirator System console. This assembly
filters any remaining particulate matter or moisture, preventing
them from entering the vacuum pump.
NOTE:
Per the CUSA® Clarity Ultrasonic Surgical Aspirator System
Operator's Manual replace the contamination guard every
six months, or sooner if necessary, when used with the CUSA
Clarity system.
Inspect the product for signs of damage before use. Refer to
the assembly instructions overleaf. Write the installation date
clearly on the Contamination Guard label.
Intended Use
The CUSA Clarity contamination guard 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.
WARNING
No modification of this equipment is allowed.
WARNING
If the aspiration tubing and contamination guard are not
connected to the correct canister ports, the system may not
work.
Disposal of the Contamination Guard
The CUSA Clarity contamination guard must be disposed of
after six months of use in accordance with regional regulation
hospital protocols.
MR Safety Information
Refer to the CUSA
Aspirator System Operator's Manual for full MR
Safety information.
PRODUCT INFORMATION DISCLOSURE
INTEGRA LIFESCIENCES CORPORATION ("INTEGRA") HAS
EXERCISED REASONABLE CARE IN THE SELECTION OF
MATERIALS AND THE MANUFACTURE OF THESE PRODUCTS.
INTEGRA WARRANTS THAT THESE PRODUCTS SHALL
CONFORM TO THE PRODUCT LIMITED WARRANTY AS
PROVIDED IN THE PRODUCT LABELING OR APPLICABLE
PRODUCT CATALOG. THIS WARRANTY IS EXCLUSIVE AND
INTEGRA DISCLAIMS ALL OTHER WARRANTIES, WHETHER
EXPRESSED OR IMPLIED, INCLUDING BUT NOT LIMITED
TO, ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE. INTEGRA SHALL NOT
BE LIABLE FOR ANY INCIDENTAL OR CONSEQUENTIAL LOSS,
DAMAGE, OR EXPENSE, DIRECTLY OR INDIRECTLY ARISING
FROM USE OF THESE PRODUCTS. INTEGRA NEITHER ASSUMES
NOR AUTHORIZES ANY PERSON TO ASSUME ANY OTHER OR
ADDITIONAL LIABILITY OR RESPONSIBILITY IN CONNECTION
WITH THESE PRODUCTS.
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Clarity Ultrasonic Surgical
®
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