WHITESTAR SIGNATURE User manual

WHITESTAR SIGNATURE ™
OWNER S AND
OPERATOR S MANUAL
Manufactured By:
Advanced Medical Optics, Inc.
1700 E. St. Andrew Place
Santa Ana, CA 92705
USA
1-800-449-3060
www.amo-inc.com
For Order Placement
of Surgical Products
(IOLs and Phaco Supplies)
Call 1-877-AMO-4LIFE (USA)
1-877-266-4543
For Phaco Returns or Technical
Service
Call 1-877-AMO-4LIFE (USA)
1-877-266-4543
All returns must be accompanied by a
RGA#
(Returned Goods Authorization)
EC REP
AMO Ireland
Block B
Liffey Valley Office Campus
Quarryvale Co., Dublin Ireland
Rx Only – Z370147 Rev C 1008
© 2008 Advanced Medical Optics, Inc.

Trademarks
AMO, the AMO ADVANCED MEDICAL OPTICS logo and WHITESTAR are registered
trademarks. ELLIPS, FUSION, LAMINAR, PHACOFIT, OCCLUSION MODE, and
WHITESTAR SIGNATURE are trademarks of Advanced Medical Optics, Inc.
DUET and SOLO are trademarks of Micro-Surgical Technology, Inc.
The Bluetooth word mark, figure mark (stylized “B Design”), and combination mark (Bluetooth
word mark and “B Design”) are registered trademarks of the Bluetooth SIG.
All brand names and products and company names mentioned in this document are the trade name,
service mark, or registered trademarks of their respective owners.
Compliance
In accordance with:
• IEC/EN 60601-1

Table of Contents
WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1008 i
TABLE OF CONTENTS
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
About this Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
About Phacoemulsification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
WHITESTAR SIGNATURE™ System Description & Features. . . . . . . . . . . . . . . . . . . . . 1-2
WHITESTAR® Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
FUSION™ Fluidics System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
WHITESTAR SIGNATURE™ System Console. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
WHITESTAR SIGNATURE™ System Operating Modes . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Receipt and Inspection Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
WHITESTAR SIGNATURE™ System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
WHITESTAR SIGNATURE™ System with FUSION™ Tubing Pack . . . . . . . . . . . . . . . 2-4
System Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Safety Precautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Warnings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
System Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12
Setup Sequence – Anterior Segment Surgery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15
Footpedal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-22
Programmable IV Pole . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-25
Wireless Remote Control (Optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-26
Surgical Media Center (SMC) (Optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-28
Shutdown Sequence – Anterior Segment Surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-30
Equipment Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Display Screens and Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Language Selection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Startup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Select Program and Install the FUSION™ Tubing Cassette . . . . . . . . . . . . . . . . . . . . . . . . 4-6
Prime/Tune . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
Verify Irrigation/Aspiration Balance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
Priming for Vitrectomy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
Selecting and Changing Mode Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12

Table of Contents
WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1008 ii
Anterior Segment Surgery Operating Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Operating Mode Descriptions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Fusion™ Fluidics Phaco . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16
Programming the Modes and Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-22
Anterior Segment – Recommended Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-38
OCCLUSION MODE™ Phaco Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-42
Passive Reflux. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-49
Ellips™ Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-49
Surgeon Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Select Surgeon/Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Add a New Surgeon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
Edit a Surgeon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
Select a Preferred Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6
Create a New Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8
Edit a Surgeon Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9
Copy a Surgeon Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10
Delete a Surgeon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11
Delete a Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-12
Delete a Database . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-13
Lock a Program. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-13
Program – Assign Order . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-14
Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
Wireless Footpedal Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
Wireless Foot Pedal Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5
Wireless Remote Control Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6
Calibrate Touch Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7
Check-out Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
System Check-out . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
Care and Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
Cleaning Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
Sterilization Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4
WHITESTAR SIGNATURE™ System Cleaning and Care . . . . . . . . . . . . . . . . . . . . . . . . 9-5

Table of Contents
WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1008 iii
Error Messages Troubleshooting and Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
Error Message Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2
Fuse Replacement Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2
Wireless Foot Pedal Battery Replacement Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3
Most Common User-Correctable Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-5
Status, Warning and Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-5
System Operation (Error) Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-5
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-16
Warranty and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
Warranty Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2
Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1
Physical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-2
Environmental Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-3
Electrical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-3
Diathermy Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-3
Irrigation and Aspiration Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-3
Phacoemulsification Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-4
Vitrectomy Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-4
Diathermy Power Graphs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-5
Diathermy Power versus Load Impedance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-10
Phaco Power Graphs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-13
Accessories and Parts Reordering . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-1
List of Accessories with Part Numbers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-2
Glossary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Glossary-1
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Index-1

WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1008 1-1
About this Manual
About Phacoemulsification
Intended Use
WHITESTAR SIGNATURE™ System Description & Features
WHITESTAR® Technology
FUSION™ Fluidics System
Accessories
WHITESTAR SIGNATURE™ System Console
WHITESTAR SIGNATURE™ System Operating Modes
1INTRODUCTION

1 • Introduction
WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1008 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.

1 • Introduction
WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1008 1-3
WHITESTAR®
Technology
The WHITESTAR® Technology represents the many enhancements to the power
modulation for the WHITESTAR SIGNATURE™ System. The WHITESTAR®
Technology enhancement was the first to deliver finely modulated pulses of
energy, interrupted by extremely brief cooling periods. This allows the
WHITESTAR SIGNATURE™ System to achieve full ultrasound cutting
efficiency and magnetic followability, while introducing less energy into the eye.
Ultrasound time is minimized or eliminated to reduce the risk of thermal damage.
WHITESTAR®ICE Technology
The WHITESTAR® ICE Technology was the next micro-pulse advance in
phacoemulsification technology, which combined modulated ultrasonic power
(pulse shaping) with vacuum control through the application of the Chamber
Stabilization Environment (CASE).
This pulse shaping technology modified the standard “square” wave pulse, by
increasing the amplitude of the first millisecond of the On Time “kick”, and then
setting the remaining part of the On Time to the standard power setting. This is
repeated for each On Time period, resulting in increased control and efficiency in
phacoemulsification.
OCCLUSION MODE™ Phaco
The OCCLUSION MODE™ Phaco is used to regulate the vacuum rise time
experiences following occlusion of the phaco tip, without limiting the choice of
aspiration rate through an unoccluded needle. In order to independently control the
aspiration rate and vacuum rise time, you can have a different aspiration rate when
the needle is occluded than when the needle is not occluded.
The OCCLUSION MODE™ Phaco is also used to regulate ultrasound power
modulation. The power modulation of the phaco handpiece (continuous, pulse,
burst) can be programmed to automatically change when the phaco tip changes
from an unoccluded condition to an occluded condition.
The FUSION™ Mode allows the user to access the settings and variables for both
CASE and OCCLUSION MODE™ Phaco. The CASE and OCCLUSION
MODE™ Phaco can be used together or independently.

1 • Introduction
WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1008 1-4
FUSION™ Fluidics
System
The WHITESTAR SIGNATURE™ System has both a flow-based peristaltic pump
system and a vacuum based Venturi pump system. The patented microprocessor-
based system continuously monitors and controls intraocular conditions of the flow
and vacuum in the eye.
Chamber Stability Environmental (CASE)
CASE is an intelligent vacuum monitoring system used to regulate the maximum
allowable vacuum that is experienced following the occlusion of the phaco tip.
When the phaco tip becomes occluded, the vacuum rises. Clearing of the occlusion
while the vacuum is at a high level can lead to a post-occlusion surge. With CASE
enabled, the System monitors the actual vacuum levels and when the vacuum
exceeds a specific threshold for a specified duration, the System automatically
adjusts the maximum allowable vacuum setting to a lower predefined CASE
maximum vacuum level. When the occlusion is cleared, the System is
automatically restored to the original programmed maximum vacuum setting. This
function makes it possible to have a different maximum vacuum setting when the
needle is occluded than when the needle is not occluded.
Accessories WHITESTAR®Handpiece
The Phaco Handpiece has been designed with a straight-through aspiration channel
for more efficient removal of nuclear fragments, to minimize clogging and to
facilitate cleaning. The hand piece is lightweight, slim, and well-balanced, making
it comfortable to use and easy to manipulate.
Ellips™ Handpiece
An Ellips™ phaco handpiece is available for use with the WHITESTAR
SIGNATURE™ System. The Ellips™ handpiece provides both longitudinal and
transversal movement. The Ellips™ handpiece provides great followability and can
be used with either a straight or a curved tip.
Footpedal
The footpedal controls the various operating modes of the instrument, and all
settings are programmed through the user interface. The WHITESTAR
SIGNATURE™ Single Linear footpedal or the wireless Advanced Control Pedal
(dual linear) can be used with the system.
The footpedal design offers control through the use of increased linearity and
uniform pressure throughout the footpedal movement, easing foot and leg fatigue.
The degrees of movement for each footpedal position can be selected and saved in
memory for each surgeon/mode, pitch for the single linear footpedal only and pitch
and yaw for the Advanced Control Pedal giving the pedal dual linear functionality.
Reflux is activated by programmable switches, giving immediate response. The
footpedal is connected to the rear of the console by a cable or can be wireless as
with the Advanced Control Pedal.

1 • Introduction
WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1008 1-5
Wireless Remote Control (Optional)
The WHITESTAR SIGNATURE™ System can be controlled from the wireless
remote control keypad. All modes can be remotely accessed, and all settings can be
adjusted with the use of the wireless remote control, including full programming
and priming capabilities. Backlighting supports low light operating room
conditions.
WHITESTAR
SIGNATURE™
System Console
Operating Room teams contributed significantly to the successful design of the
WHITESTAR SIGNATURE™ System Cart. The solid wheel base and locking
wheels make the cart stable and smooth rolling. An adjustable height Mayo tray
accommodates the handpieces and tubing. The remote control is wireless and
recharges when the remote control is placed in the storage bay. An open bin and
footpedal platform are available for storage.
WHITESTAR SIGNATURE™ System Display (Graphic User
Interface-GUI)
The WHITESTAR SIGNATURE™ System graphic screen display is easy to read
and easy to operate. You can see at a glance the status of the system. The screen
gives you visual indication of operating modes, settings, and system status.
Messages cue you through the procedure, and error messages indicate improper
connections or selections. Help information is available from the touch screen
controls.
Prime/Tune
Before the start of each surgical case, the system requires Prime, Tune or Prime/
Tune to be executed. The Prime mode incorporates the function of tubing purge,
and fills and completes the fluid aspiration and vacuum check. The Tune mode
incorporates the ultrasonic power calibration and safety check for the connected
phaco handpiece. The Prime/Tune mode allows the system to prime and tune the
handpiece at the same time.
Dual Pump
The WHITESTAR SIGNATURE™ System provides a fluid aspiration system
using either a peristaltic (flow-based) pump or a Venturi (vacuum-based) pump
system. The surgeon can utilize the Venturi pump in the Phaco, IA, and Vitrectomy
surgical modes.
Continuous Irrigation
Continuous Irrigation is immediately available via dedicated keys on the touch
screen and the wireless remote control. Surgeon control of Continuous Irrigation
with the footpedal is also available. Continuous Irrigation can be used to fill cups
prior to Prime/Tune. The Cup Fill feature can be used in place of Continuous
Irrigation when you fill a cup. The Cup Fill feature is only available from the
Prime/Tune screen. (See Chapter 4 Equipment Operation, Prime/Tune for Detailed
information.)

1 • Introduction
WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1008 1-6
Programmable Operating Parameters
The WHITESTAR SIGNATURE™ System is programmable through the screens
on the touch screen monitor. You can select your desired settings for each portion
of the anterior surgical procedure. Up to 50 surgeon names with a maximum of 20
different setups, plus the AMO™ default settings program can be stored in the
instrument program memory. This allows different users to preset their preferences,
or an individual user to select setups for different procedures, including a
personalized initial operating mode.
MMP – Multiple Mode Programming
Multiple submodes are available within the WHITESTAR SIGNATURE™ System
operating modes. This allows you to preset your settings for specific techniques
such as phaco chop or viscoelastic removal.
Programmable IV Pole
The WHITESTAR SIGNATURE™ System is equipped with a programmable IV
pole. The programmable IV pole height settings can be entered independently for
each of the PHACO modes plus settings for Diathermy, IA and Vitrectomy. During
surgery, the programmable IV pole height changes to the preprogrammed height
when you switch modes.
The automated and programmable IV pole allows adjustment of the bottle height to
provide gravity infusion through each procedural phase. Two adjustment keys on
the touch screen or the wireless remote control are used to raise and lower the
bottled balanced salt solution, while maintaining the sterility of the operating field.
A separate up and down switch allows IV pole adjustment from the side of the
system.
WHITESTAR
SIGNATURE™
System Operating
Modes
The WHITESTAR SIGNATURE™ System was designed to provide all the
Operating Modes and surgical capabilities required by the anterior segment or
cataract surgeon. These capabilities include:
Diathermy (DIA)
The Diathermy mode is used by most surgeons to coagulate blood vessels during
the procedure and by some surgeons to “coag” the conjunctiva at the end of the
procedure. An isolated output frequency allows non-contact tissue coagulation,
eliminating adhesion and traction. Also, the depth of penetration of the energy field
is less than that of lower frequency units, which minimizes tissue shrinkage or
charring. The gentleness of the diathermy mode allows the surgeon to stop
“bleeders” within the incision with only minimal scleral shrinkage.

1 • Introduction
WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1008 1-7
Phacoemulsification (PHACO)
The Phacoemulsification mode is used to break up (emulsify) the nucleus of the
lens and then allows the nucleus of the lens to be aspirated from the eye through a
small incision. The continuous autotuning circuitry maximizes the emulsification
efficiency for each lens density, even varying densities within the same lens. Phaco
time is displayed in minutes and seconds. The convenient selection of linear or
panel preset phaco power, in a variety of power delivery options (pulsed, burst,
transversal), provides increased precision and control.
The WHITESTAR® Technology allows you to safely remove all lens types through
small incisions with single-mode, single-instrument convenience.
The WHITESTAR® Technology is a patented software application proven to
change the characteristics of phacoemulsification using little or no ultrasound. This
is done by changing the thermal properties and improving control of the lens
without reducing the cutting power or changing technique or efficiency.
CASE One Touch
The One Touch button simplifies the programming of the CASE function and
allows you to easily define the basic CASE settings once. The CASE function can
then be adjusted quickly with the CASE One Touch settings on the surgical
screens. When these controls are used, the CASE functionality can be changed to
provide enhanced control or improved efficiency to suit any particular combination
of cataract density, surgical technique or personal preferences.
Irrigation/Aspiration (IA)
The Irrigation and Aspiration mode allows for controlled aspiration of cortical
material from the eye, while maintaining intraocular stability, by replacing the
aspirated material with a balanced salt solution. A peristaltic pump provides a
predictable and stable aspiration rate. Complete control is achieved with
“Aspiration Rate” and “Vacuum”. Irrigation is gravity-fed.
The gravity-fed mode is regulated by adjusting the height of the balanced salt
solution bottle. This mode gives you flexible control of each case with
independently adjustable vacuum level and flow rate settings.
Vitrectomy (VIT)
The Vitrectomy mode is used to remove vitreous from the eye during surgery. The
WHITESTAR SIGNATURE™ System uses air pressure to drive the vitreous
cutter. The wide range of user-controlled, programmable cut rates supports both
anterior segment and posterior segment surgeries.

WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1008 2-1
Receipt and Inspection Instructions
WHITESTAR SIGNATURE™ System Components
WHITESTAR SIGNATURE™ System with FUSION™ Tubing Pack
2SYSTEM COMPONENTS

2 • System Components
WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1008 2-2
Receipt and
Inspection
Instructions
When you receive your WHITESTAR SIGNATURE™ System inspect the exterior
packaging for any signs of damage that might have occurred during shipping and
record this damage on the shipping documents. If there are any signs of damage,
carefully unpack the WHITESTAR SIGNATURE™ System and inspect the
System for damage. If any damage to the package contents has occurred, you must
immediately file a claim with the transporter. The transporters accept claims only
from the recipient (you), not from the shipper (AMO).
Your AMO Representative will have contacted you to schedule both the
Installation and the In-Service Training when you receive your new WHITESTAR
SIGNATURE™ System. We suggest that you leave the WHITESTAR
SIGNATURE™ System in the original packaging and store the package in a
cool, dry environment until the AMO installation personnel arrive to assemble,
install and test your equipment. Extreme heat, cold or moisture can damage any
electronic equipment.
WHITESTAR
SIGNATURE™
System Components
Your WHITESTAR SIGNATURE™ System consists of some or all of the
following components:
• WHITESTAR SIGNATURE™ System console with an integral cart, mayo tray
on an adjustable arm and a Programmable IV Pole
• FUSION™ Tubing Pack (disposable)
• Footpedal and Power Cord (Single or Advanced Control Pedal (Dual Linear))
• Power Cord (detachable)
• Wireless Remote Control Module
• WHITESTAR SIGNATURE™ System Owner s Manual

2 • System Components
WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1008 2-3
Figure 2.1 – WHITESTAR SIGNATURE™ System
1. Programmable IV Pole 4. WHITESTAR SIGNATURETM System console
with Integral Cart and Mayo Tray
2. FUSIONTM Tubing Cassette
3. Wireless Remote Control Module (Storage bay on
top of the system)
5. Footpedal
1
2
3
4
5

2 • System Components
WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1008 2-4
WHITESTAR
SIGNATURE™
System with
FUSION™ Tubing
Pack
Each surgical procedure requires a disposable FUSION™ Tubing Cassette for
either the peristaltic pump or the Venturi pump. The FUSION™ Tubing Cassette
only works with the peristaltic pump, which is used in anterior/cataract surgeries.
The Dual Pump Tubing Cassette works with both the peristaltic pump and the
Venturi pump. With the Fusion™ Dual Pump Pack you can select either pump
while you are in a surgical case.
The tubing pack contains the following components:
• Tubing cassette with irrigation and aspiration tubing (administration set) with an
attached, sealed drain bag
• Infusion Sleeve
• Test Chamber – to test and prime/tune the phaco handpiece
• Mayo Stand Drape – to cover the Mayo tray and arm
• Monitor Drape – to cover the front of the touch screen
Figure 2.2 – FUSION™ Tubing Cassette
Proper handling and disposal methods for biohazards must be used when
you dispose of the tubing cassette, Mayo stand drape and monitor drape.
!

WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1008 3-1
Safety Precautions
Warnings
Symbol Definitions
System Disposal
Setup Sequence – Anterior Segment Surgery
Footpedal
Programmable IV Pole
Wireless Remote Control (Optional)
Surgical Media Center (SMC) (Optional)
Shutdown Sequence – Anterior Segment Surgery
3SYSTEM SETUP

3 • System Setup
WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1008 3-2
Safety Precautions Now that the system is set up and you have verified that all of the functions are
operating properly, you are almost ready to use your WHITESTAR
SIGNATURE™ System.
Read the following Safety Precautions and Warnings carefully before you use the
WHITESTAR SIGNATURE™ System in surgery.
1. The WHITESTAR SIGNATURE™ System is equipped with 3-prong power
plug which must be plugged into an outlet with a ground receptacle.
If the plug does not fit the outlet, contact an electrician. DO NOT modify or
remove the ground pin.
2. Do not use extension cords with your system.
3. Do not overload your electrical receptacle (outlet).
4. If the cord or plug is damaged, do not use the instrument. An electric shock or
fire hazard can result. Call AMO customer service to order a new cord.
5. The instrument has ventilation openings at the rear of the console to allow
ambient air intake and the release of heat generated during operation. If the
openings are blocked, heat build-up can cause system failures which can result
in a fire hazard.
6. Do not try to move the WHITESTAR SIGNATURE™ System cart on deep
pile carpets or over objects on the floor such as cables and power cords.
7. Take care not to trip over power and footpedal cords.
8. Do not try to lift the WHITESTAR SIGNATURE™ System cart.
9. Do not place the instrument on uneven or sloped surfaces.
10. Do not use disposables, accessories or other surgical instruments that are not
designed for this system. Use only parts recommended by AMO to achieve
optimum performance and safety.
11. Do not operate the WHITESTAR SIGNATURE™ System in a condensing
environment. Take care to protect the instrument from fluid sprays or fluid
buildup.
12. To protect the patient from contaminated fluids or handpieces, use only:
• sterile tubing cassettes
• sterile irrigation fluid
• sterile handpieces
13. Use caution when you extend, retract or swivel the Mayo stand articulating
arm. Stay clear of the hinged hardware.
14. Use caution when you use handpieces with sharp edges or pointed tips.