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Important Safety Information

Intended Use

The WHITESTAR Signature® System is a modular ophthalmic microsurgical system that facilitates anterior segment (cataract surgery. Risks and complications may include broken ocular capsule or corneal burn. Consult with your eye care professional for a complete listing of contraindications and risks.

Safety Precautions

Read the following Safety Precautions and Warnings carefully before you use the WHITESTAR Signature® System in surgery.

Warnings and Cautions

General:

Vitrectomy

Phaco Handpiece

Footpedal

WARNING: NEVER handle the footpedal by the cable

WARNING: Use only NiMH type batteries in the Advanced Control Pedal

Diathermy

CAUTION: If a tone is not heard when the footpedal is pressed and volume adjustment is unseccussful, the mode is not functioning properly. Refer to Operator’s Manual.

Remote control

WARNING: DO NOT try to replace the Wireless Remote Control batteries. Call your AMO Technical Service representative to replace the batteries

Contraindication and Adverse Events Statement

Risks and complications may include broken ocular capsule or corneal burn. Please reference the WHITESTAR Signature® Operators Manual for more information on intended use, warnings and precautions.

US Federal law restricts this device to sale, distribution, and use by or on the order of a physician or other licensed eye care practitioner.

The product may contain mercury. Please dispose accordingly to state, local or federal laws.