User's Manual

1 • Introduction
WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 1-2
About this Manual This manual includes information about the WHITESTAR SIGNATURE™
System which is designed for anterior segment (phacoemulsification) surgical
procedures.
This manual includes information regarding optional System enhancements. The
availability of these features in your System configuration and availability in your
area can be confirmed by your AMO representative.
About
Phacoemulsification
Over thirty years ago, Dr. Charles Kelman conceived and developed
phacoemulsification, a method of cataract removal using ultrasonic emulsification
and aspiration of the cataractous lens through a small incision. Phacoemulsification
is advantageous for both patient and surgeon:
Greater intraoperative control.
The smaller incision requires fewer or no sutures, poses less risk of infection and
induced astigmatism, and gives better long-term and short-term predictability of
vision.
Patients are able to resume normal activity much sooner and with fewer
restrictions than with traditional cataract extraction surgeries.
Advanced Medical Optics, Inc. (AMO) supports phacoemulsification with
sophisticated instrumentation that optimizes the benefits of this surgical procedure.
Intended Use The WHITESTAR SIGNATURE™ System is a modular ophthalmic microsurgical
system that facilitates anterior segment (cataract) surgery. The modular design
allows the users to configure the system to meet their surgical requirements.
This HIGH FREQUENCY (HF) SURGICAL EQUIPMENT is specified for use
without a NEUTRAL ELECTRODE.
WHITESTAR
SIGNATURE™
System Description
& Features
The WHITESTAR SIGNATURE™ System is a multi-functional tool for use in
anterior segment surgery and procedures. The WHITESTAR SIGNATURE™
System represents the latest generation of AMO
®
phacoemulsification technology.
Safety, ease-of-use, and reliability are designed and manufactured into every
WHITESTAR SIGNATURE™ System. The WHITESTAR SIGNATURE™
System meets applicable United States and International safety requirements for
this type of device.
The WHITESTAR SIGNATURE™ System contains a number of features based on
extensive research and clinical trials with highly-trained and noted
ophthalmologists who are experienced phacoemulsification surgeons.