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01-50-1503

Arthrotek, Inc.	01-50-1503
4861 E. Airport Dr.	Date: 03/04
Ontario, California 91761

ARTHROTEK® INNERVUE™ DISPOSABLE MICRO-ENDOSCOPE

ATTENTION OPERATING SURGEON

DESCRIPTION:
Arthrotek® InnerVue™ disposable micro-endoscope is a small fiberoptic based endoscope. The disposable micro-endoscope is for one-time use only. Arthrotek® InnerVue™ cannula, trocar, blunt obturator, and cannula plug are used with the disposable micro-endoscope. Arthrotek® InnerVue™ disposable micro-endoscope is made to couple with a non-disposable system handpiece that contains a light source and camera.

MATERIALS:

Micro-endoscope

Stainless Steel
Glass
Medical grade epoxy
Lexan or Radel

INDICATIONS FOR USE
This device is to be used by a trained physician for viewing an interior cavity of the human body through either a surgical or natural opening.

CONTRAINDICATIONS
Active infection is a contraindication for use of this device.

WARNINGS

Arthrotek® InnerVue™ micro-endoscope is provided sterile.
Always inspect the micro-endoscope for any evidence of damage prior to use. Pay particular attention for scratches on optical surfaces. Scratches can interfere with image quality.
Use caution to treat the micro-endoscope as you would any fine optical device.
One time use only. Do not reuse the micro-endoscope.

POSSIBLE ADVERSE EFFECTS

Infection following the procedure.
Introduction of foreign materials can result in an inflammatory response or allergic reaction.
Wound dehiscence.
Nerve damage.
Damage to tissue and/or bone near or around micro-endoscope when inserted into a surgical or natural opening.

INSTRUCTIONS FOR USE
Arthrotek® InnerVue™ micro-endoscope is to be used by a trained physician for viewing the interior cavity of human anatomy. The endoscope can be passed through a surgical or natural opening. The cannula with trocar or obturator is placed into the surgical or natural opening. Once the cannula has been placed, the trocar or obturator is removed. The cannula is then used as an insertion tube for the endoscope. Fluid may be introduced or removed from the cavity through the stopcock on the cannula, with or without the use of the cannula plug.

STERILITY
Sterilization of the micro-endoscope
Arthrotek® InnerVue™ disposable micro-endoscope is sterilized by exposure to Ethylene Oxide (ETO) gas. Arthrotek® InnerVue™ disposable micro-endoscope is for one-time, single patient use only.

DO NOT STEAM AUTOCLAVE the Arthrotek® InnerVue™ disposable micro-endoscope as it will be irreparably damaged by steam autoclaving.

Cleaning of the handpiece
The handpiece can be cleaned and disinfected with cleaning agents meant for the cleaning of electrical equipment. Follow manufacturer instructions. DO NOT use cleaning agents that are not compatible with plastics. DO NOT allow excessive moisture or liquids to come in direct contact with the handpiece.

Caution: Federal Law (USA) restricts this device to sale, distribution, or use by or on the order of a physician.

Manufacturer:	Distributed by:
Clear Image Technologies, Inc.	Arthrotek, Inc.
1005 Abbe Road North	4861 Airport Drive
Elyria, OH 44035	Ontario, CA 91761