Johnson and Johnson Surgical Vision SIGACPM Advanced Control Pedal Master User Manual Whitestar OM
Abbott Medical Optics Advanced Control Pedal Master Whitestar OM
Users Manual
DOCUMENT NO: Z370147 REVISION: MANUAL SPECIFICATION TITLE: WHITESTAR SIGNATURETM OWNER’S AND OPERATOR’S MANUAL (ENGLISH) SOFTWARE VERSION 1.003, CE SPECIFICATIONS: 1. BINDER: 8 ½” x 11 x 1 ½” White vinyl with clear-view insert pockets or equivalent, 3 rings. 2. TEXT: 2.1 DIMENSIONS: 8 1/2“ x 11” three rings, white laser paper 2.2 TYPE OF PAPER: 20lb. Bond, White, 3 ring punched 2.3 INK/COLOR: Black on white paper. Printing to be clear and legible with no ink smears. 2.4 TYPE OF COPY: Single Copy, print 2 sides. Each chapter must start on a rightfacing page. 3. COVER & SPINE: Z330075 for Label Specifications. 4. TAB PAGES: 5. ASSEMBLY / PACKAGING: Index tabs in the appropriate sections of the manual. Shrink-wrap assembled binder with copy of first page of document (cover page) between shrink and outside of binder. Manual identify from cover page (version, part number, etc.) must be facing out and visible for warehouse identification. 6. LANGUAGES: 7. POINTS OF USE: AMO, Corporate, Santa Ana, Milpitas Z330077 for Label Specifications. English CHANGE SUMMARY REVISION DESCRIPTION OF CHANGE Create new manual for WHITESTAR SIGNATURETM Owner’s manual Software Version 1.03. For clinical use only. Production manual for the 1.03 software version – updates for Venturi in all surgical modes and the Dual Linear Foot Pedal (Advanced Control Pedal) Update to Reflux Description, Distributor address, New terms in glossary – New screens for Passive Reflux. Page 1 of 204 WHITESTAR SIGNATURE ™ OWNER’S AND OPERATOR’S MANUAL Manufactured By: Advanced Medical Optics, Inc. 1700 E. St. Andrew Place Santa Ana, CA 92705 USA For Order Placement of Surgical Products (IOLs and Phaco Supplies) Call 1-877-AMO-4LIFE (USA) 1-877-266-4543 1-800-449-3060 www.amo-inc.com For Phaco Returns or Technical Service Call 1-877-AMO-4LIFE (USA) 1-877-266-4543 EC REP AMO Ireland Block B Liffey Valley Office Campus All returns must be accompanied by a RGA# (Returned Goods Authorization) Quarryvale Co., Dublin Ireland Rx Only – Z370147 Rev C 1108 © 2008 Advanced Medical Optics, Inc. Trademarks AMO, the AMO ADVANCED MEDICAL OPTICS logo, and WHITESTAR are registered trademarks and ELLIPS, the ELLIPS logo, FUSION, the FUSION logo, LAMINAR, PHACOFIT, OCCLUSION MODE, and WHITESTAR SIGNATURE are trademarks of Advanced Medical Optics, Inc. DUET and SOLO are trademarks of Micro-Surgical Technology, Inc. Bluetooth is a registered trademark of Bluetooth SIG, Inc. 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 TABLE OF CONTENTS Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 1-2 1-2 1-2 1-3 1-4 1-4 1-5 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) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-27 Shutdown Sequence – Anterior Segment Surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-29 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 WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 Table of Contents Anterior Segment Surgery Operating Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1 Operating Mode Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2 Fusion™ Fluidics Phaco . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15 Programming the Modes and Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-21 Anterior Segment – Recommended Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-37 OCCLUSION MODE™ Phaco Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-41 Passive Reflux. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-48 Ellips™ Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-48 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Wireless Footpedal Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Wireless Foot Pedal Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Wireless Remote Control Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Calibrate Touch Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2 7-3 7-5 7-6 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 WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 ii Table of Contents 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-15 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 1108 iii 1 INTRODUCTION 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 WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 1-1 1 • Introduction 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. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 1-2 1 • Introduction 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. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 1-3 1 • Introduction FUSION™ Fluidics System The WHITESTAR SIGNATURE™ System has both a flow-based peristaltic pump system and a vacuum based Venturi pump system. The patented microprocessorbased 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. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 1-4 1 • Introduction 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.) WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 1-5 1 • Introduction 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. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 1-6 1 • Introduction 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 1108 1-7 2 SYSTEM COMPONENTS Receipt and Inspection Instructions WHITESTAR SIGNATURE™ System Components WHITESTAR SIGNATURE™ System with FUSION™ Tubing Pack WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 2-1 2 • System Components 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 WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 2-2 2 • System Components Figure 2.1 – WHITESTAR SIGNATURE™ System 1. Programmable IV Pole 2. FUSIONTM Tubing Cassette 3. Wireless Remote Control Module (Storage bay on top of the system) WHITESTAR SIGNATURE™ System 4. WHITESTAR SIGNATURETM System console with Integral Cart and Mayo Tray 5. Footpedal Rx Only – Z370147 Rev. C 1108 2-3 2 • System Components 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 1108 2-4 3 SYSTEM SETUP 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 WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 3-1 3 • System Setup 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. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 3-2 3 • System Setup 15. Always replace the tubing cassette between cases. 16. Wrap the excess power cord neatly around the cord wrap on the back of the console. Changing Irrigation Flow Use extreme caution when you lower or raise the balanced salt solution bottle to decrease or increase fluid flow and pressure. If you lower the bottle too much it can cause the anterior chamber to collapse. If you raise the bottle too high it can cause the anterior chamber to deepen. To make sure that the bottle height does not go too high, you can set the maximum bottle height on the Diagnostics screen. Note: Use a new bottle of balanced salt solution at the start of each case. Phacoemulsification without Adequate Irrigation Operating phacoemulsification without an adequate irrigation flow can result in an elevated temperature of the tip and subsequent damage to the eye tissue or could cause the chamber to collapse. Confirm that there is irrigation flow before you initiate phacoemulsification. A tight wound or the angle of the needle next to the wound can also constrict the irrigation flow by pinching the coaxial irrigation sleeve assembly on the needle of the phaco handpiece. Power Failure during Surgery If there is a loss of power during a procedure, you need to: • Withdraw the handpiece from the eye • Release the footpedal to Position 0 When power is restored: • Select Prime/Tune to reprime the fluids and tune the phaco handpiece. Use Bypass to reduce the length of prime time. • Select the mode that was in use when power was lost (PHACO, IA, Vitrectomy or Diathermy) Connecting Handpieces It is very important that the electrical connectors on the handpieces are completely dry before they are connected to the WHITESTAR SIGNATURE™ System receptacles. You can receive a “Handpiece Ground Fault Error” message if the connector is wet. Handling the Phaco Handpiece The phaco handpiece is a very delicate instrument and must be handled with EXTREME care. If the handpiece is dropped or receives any other significant impact, the handpiece will not work properly. The ultrasonic titanium phaco tip must never touch any solid material while in use. Always flush the handpiece immediately following surgery. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 3-3 3 • System Setup See cleaning instructions given in Chapter 9, “Care and Cleaning”. Handpieces can be extremely hot immediately after sterilization. Use care and caution when handling. Phaco and Vitrectomy Operation The phaco handpiece and the vitrectomy cutter must never be activated with the tips exposed to air. If the tips are activated in the air, the useful life of the handpiece and the cutter is reduced. If power is to be introduced to the phaco handpiece or the vitrectomy cutter, the tips must be in a test chamber filled with a balanced salt solution, in a container of balanced salt solution, or in the patient's eye. Vitrectomy Failure to properly attach the tubing to the appropriate vacuum or pressure source can affect the vitrectomy cutter operation. Be sure to read the vitrectomy cutter package insert for correct assembly and connection procedures. Diathermy When you enter the Diathermy mode, an audible tone should be heard. Also, whenever diathermy power is applied, an audible tone should be heard. The diathermy cable must be checked periodically for damage. If the cable shows signs of damage, replace the cable immediately with the same type of cable. Use of other types of cables can affect the diathermy performance. During surgery, the diathermy output power must be as low as possible for the intended purpose. AMO recommends the 30% setting to start. The diathermy cable must be positioned in such a way that contact with the patient or other leads is avoided. Grounded or ungrounded metal parts must not come in contact with the patient when diathermy is used. For proper operation of the diathermy, replace the handpiece with the same type. Programmable IV Pole Do not exceed the maximum weight of two 500 ml balanced salt solution bottles on the IV pole bottle holder. Wireless Remote Control and Wireless Foot Pedal These devices comply with part 15 of the FCC (Federal Communications Commission) Rules. Operation is subject to the following two conditions: 1. This device may not cause harmful interference. 2. This device must accept any interference received, including interference that may cause undesired operation. Any changes or modifications not expressly approved by Advanced Medical Optics, Inc. can void the user's authority to operate the equipment. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 3-4 3 • System Setup Note: This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense. Warnings WARNING: All personnel who might operate this equipment must read and understand the instructions in this manual before the system is used. Failure to do so might result in the improper operation of the system. This device is only to be used by a trained licensed physician. WARNING: The fluid level in the balanced salt solution bottle must be monitored by the surgical nursing staff. The result of a low bottle or an empty bottle affects the fluid balance and the intra-ocular pressure (IOP) while aspirating. The low or empty bottle can result in: • The inadvertent chamber shallowing or collapse • The Aspiration of tissue • An ultrasonic wound heating commonly called wound burn (extreme case) The surgical staff must monitor the fluid level at all times. WARNING: DO NOT attempt to use the system if the system fails to perform properly as stated in this manual. WARNING: DO NOT use the System in the presence of flammable anesthetics, or other flammable gases, near flammable fluids or objects, or in the presence of oxidizing agents, as a fire could result. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 3-5 3 • System Setup WARNING: This unit might interfere with any cardiac pacemaker fitted to the patient; therefore qualified advice must be obtained prior to such use. WARNING: The patient must not come into contact with metal parts which are grounded or have appreciable capacitance to ground. The use of an antistatic mat for this purpose is recommended. WARNING: Proper handling and disposal methods for biohazards must be used when you dispose of the tubing cassette, mayo stand drape and monitor drape. WARNING: Monitoring electrodes or other types of equipment must be placed as far from those of the WHITESTAR SIGNATURE™ System as possible. High current limiting devices are recommended for the protection of such systems. Needle monitoring electrodes are not recommended. WARNING: Keep the diathermy cord away from the patient and other handpieces or leads (for example, monitoring electrodes). WARNING: The output power selected must be as low as possible for the intended purpose. WARNING: Although this unit complies with all Electromagnetic Interference (EMI) standards and requirements, it is possible that interference provided by the operation of the HIGH FREQUENCY (HF) SURGICAL EQUIPMENT can adversely influence the operation of other electronic equipment. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 3-6 3 • System Setup WARNING: Skin to skin contact on the patient, for example, between the arms and the torso is not recommended. Insert dry gauze to avoid contact, as appropriate. Note: The unit does not contains any neutral electrode. Note: The diathermy output is bipolar. Note: It is recommended that the condition of all inter-connecting and handpiece cables be checked on a regular basis. WARNING: Risk of burns and fire. Do not use the system near conductive materials such as metal bed parts, inner spring mattresses, or similar items. Replace electrode cables on evidence of deterioration. WARNING: Hazardous electrical output. This equipment is for use only by qualified personnel. WARNING: Disconnect the power before you service the equipment. WARNING: Remove the power cord from the power outlet when the equipment is not in use. WARNING: Do not obstruct the power outlet so that the power cord can be readily removed, as needed. WARNING: Not recommended for use in condensing environments. If exposed to a condensing environment, allow the system to equilibrate to typical operating room conditions prior to use. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 3-7 3 • System Setup WARNING: This HIGH FREQUENCY (HF) SURGICAL EQUIPMENT is specified for use without a NEUTRAL ELECTRODE. WARNING: Failure of the HIGH FREQUENCY (HF) SURGICAL EQUIPMENT could result in an unintended increase of output power. WARNING: DO NOT try to replace the Wireless Remote Control batteries. Call your AMO Technical Service representative to replace the batteries. WARNING: Sterility assurance is the responsibility of the user. All nonsterile accessories must be sterilized prior to use. WARNING: Prior to using any invasive portions of the handpiece assembly, examine under the microscope for any obvious damage, oxidation, or the presence of foreign material. If any questionable characteristics are noted, use a backup handpiece for surgery. Use of contaminated or damaged system accessories can cause patient injury. WARNING: Use of non-AMO approved products with the WHITESTAR SIGNATURE™ System, can affect overall system performance and is not recommended. AMO cannot be responsible for system surgical performance if these products are utilized in surgery. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 3-8 3 • System Setup Symbol Definitions The following symbols appear on the WHITESTAR SIGNATURE™ System front and back panels and in the software: Table 3.1 – Symbol Definitions Symbol Definition Symbol on power switch indicates Power is On. Symbol on power switch indicates Power is Off. Indicates that there are important operating and maintenance instructions included in the Owner’s and Operator’s Manual. Indicates the presence of uninsulated high voltage inside the instrument. Risk of electric shock. Do not remove the instrument cover. Indicates fuse. Single phase alternating current. Patient applied part is isolated from earth ground. Patient applied part is grounded OR no direct electrical energy is involved. Footpedal connection. Communications Port WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 3-9 3 • System Setup Symbol Definition Programmable IV Pole Diathermy Receptacle Phaco Handpiece Receptacle Vitrectomy Cutter Connection Potential Equalizer Indicates compliance with the Medical Device Directive. 0050 Separate Disposal/Collection Required Environment Friendly Use Period in Years (RoHS) Indicates compliance with IEC 60601-1-2:2001, “Electromagnetic Compatibility Requirements and Tests for Medical Electrical Equipment.” ETL Listed Mark issued to those products that have met the requirements of product safety standards for the United States and Canada. (ETL formerly Edison Testing Laboratory) WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 3-10 3 • System Setup Symbol Definition Universal Serial Bus (USB) Port Note: Use only AMO recommended USB stick drives. Federal Communications Commission (FCC) The FCC regulates interstate and international communications by radio, television, wire, satellite and cable under the FCC’s jurisdiction. FUSION™ Mode button used to open the CASE settings screen. Single Linear Foot Pedal Icon. Shows the position of the footpedal when the footpedal is pressed. The number shown changes when the position is changed. Advanced Control Pedal (Dual Linear) Icon. Shows the position of the footpedal when the footpedal is pressed. The number shown changes when the position is changed. The letters indicate the location of Aspiration (A), Irrigation (I), Phaco (P), Reflux (R), Whitestar Increment/Decrement (WS) and Switch (S). WHITESTAR® Technology is On. WHITESTAR® Technology is On and ICE Pulse Shaping is On. Ellips™ Technology is On. Reload button is used to cycle through the surgeon’s programs. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 3-11 3 • System Setup System Disposal WEEE The electronic components of the WHITESTAR SIGNATURE™ System are subject to the European Union Directive 2002/96/EC on Waste Electrical and Electronic Equipment. This directive applies to all electronic equipment in the European Union only. The disposal to municipal waste is prohibited for electronic equipment subject to this directive; this equipment must be treated or recycled. Each component that is subject to this regulation is marked on the component itself with the following symbol: In some cases where the component’s size prohibits marking (such as handpieces) the marking can be found on the directions for use and the warranty. Treatment and/or recycling of the electronic equipment are provided at no cost to you. Please see the contact information below for disposition of unwanted AMO electronic equipment. For disposal of your unit, contact your local AMO subsidiary or the AMO service center nearest you. Belgium Denmark Contact De Ceunynck Medical nv/sa Kontichsesteenweg 36 B-2630 AARTSELAAR Belgium Distributor AMO Denmark ApS c/o Advanced Medical Optics Norden AB Kanalvagen 3A SE 194 61 Upplands Vasby Sweden Finland France AMO Norden AB Vantaa/Finland Rajatorpantie 41 C, 3. krs FIN-01640 Vantaa Finland Phone: +358 9 8520 2192 AMO France SAS Greenside 15, 750 Avenue de Roumanille 06410 Biot France Phone: +33 4 93 00 11 95 WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 3-12 3 • System Setup Germany Greece AMO Germany GmbH Rudolf-Plank Strasse 31 D-76275 Ettlingen Germany Phone: +49 7243 729 444 (Hotline) Distributor Nexus Medicals s.a. 12th km Nat. Road Ave AthensLamia & Zakynthou str. 14451 Metamorfosi Athens Greece Ireland Italy AMO Ireland Block B Liffy Valley Office Campus Quarryvale, Co. Dublin Ireland AMO Italy Srl Via Pio Emmanuelli, n.1 00143 Rome Italy Phone: +39 06 51 29 61 Netherlands Norway AMO Netherlands B.V. Kantoorgebouw La Residence Weverstede 25 3431 JS Nieuwegein The Netherlands Phone: +31 (0)30 600 8787 Distributor Advanced Medical Optics Norway AS c/o Advanced Medical Optics Norden AB Kanalvagen 3A SE 194 61 Upplands Vasby Sweden Poland Portugal Distributor Oko-Vita Polska sp.z.o., ul Marywilska 34, 03-228 Warsaw, Poland Advanced Medical Optics Spain S.L. sucursal em Portugal Praca Nuno Rodreguez dos Santos no 7, 1600-171 Lisboa Portugual Russia Spain Distributor Tradomed Ltd., Marksistskaya Str. 3, Bld 1, Moscow, 109147, Russia Advanced Medical Optics Spain, S.L. c/Dr. Zamenhof, n. 22, 4B 28027 Madrid Spain Phone: +34 9176 88 000 WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 3-13 3 • System Setup Sweden Switzerland Advanced Medical Optics Norden AB Kanalvagen 3A SE 194 61 Upplands Vasby Sweden Distributor AMO Switzerland GmbH, Churerstrasse 160 B, CH-8808 Pfäffikon, Switzerland United Kingdom AMO United Kingdom Ltd Jupiter House Mercury Park Wooburn Green High Wycombe Buckinghamshire HP10 0HH United Kingdom Phone: +44 1628 551600 RoHS (Restriction of Hazardous Substances) For Chinese Regulation: Administrative Measure on the Control of Pollution Caused by Electronic Information Products Table 3.2 – Names and Content of Toxic and Hazardous Substances or Elements Parts Name Toxic and Hazardous Substances or Elements Pb Hg Cd Cr6+ PBB PBDE Housing Power Supply Motherboard Rear Panel Assembly Board Pneumatics LCD Base Unit Fluidics o: Indicates that this toxic or hazardous substance contained in all of the homogeneous materials for this part is below the limit requirement in SJ/ T11363-2006 x: Indicates that this toxic or hazardous substance contained in at least one of the homogeneous materials used for this part is above the limit requirement in SJ/T11363-2006 (Enterprises may further provide in this box technical explanation for marking "X" based on their actual conditions.) WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 3-14 3 • System Setup Setup Sequence – Anterior Segment Surgery The following is a general overview of the steps to be taken to prepare the WHITESTAR SIGNATURE™ System for surgery: 1. Connect the WHITESTAR SIGNATURE™ System power cord to the rear of system. Plug the power cord into a grounded power outlet. 2. Connect the footpedal to the rear panel receptacle. 3. Connect the compressed air line to the compressed air receptacle (optional). 4. Turn the system On at the back of the console. 5. Press the On/Off button on the Touch Screen monitor. 6. After completion of the Start Up Self Test, select the surgeon and program. 7. Install the tubing cassette, attach the required accessories (phaco, vitrectomy or diathermy handpieces) and set up the tubing. 8. Prime and tune the handpieces. (Refer to Chapter 4, Equipment Operation, Prime/Tune.) 9. Perform the final test of the fluidics and the handpiece integrity with the footpedal. (Refer to Chapter 4, Equipment Operation, Verify Irrigation/ Aspiration Balance.) WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 3-15 3 • System Setup Figure 3.1 – Rear Panel Connections 1. USB Port 2. Communications Port 3. Foot Pedal Connector 4. Compressed Air 5. Potential Equalizer 6. Power Switch and Power Cord Connection Phacoemulsification Ultrasonic Handpiece WARNING: Sterility assurance is the responsibility of the user. All nonsterile accessories must be sterilized prior to use. WARNING: Prior to using any invasive portions of the handpiece assembly, examine under the microscope for any obvious damage, oxidation, or the presence of foreign material. If any questionable characteristics are noted, use a backup handpiece for surgery. Use of contaminated or damaged system accessories can cause patient injury. 1. Use caution to prevent burns when handling the handpiece directly from sterilization. 2. Remove the tubing cassette and accessories from the tubing pack and place them in the sterile area. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 3-16 3 • System Setup 3. Assemble the phaco handpiece as shown below. You need the handpiece, titanium phaco tip, the appropriate tip wrench, one of the infusion sleeves and the test chamber. CAUTION: NEVER ATTEMPT TO STRAIGHTEN A BENT NEEDLE. THIS MIGHT PRODUCE A BROKEN TIP WHEN ULTRASOUND IS APPLIED. Figure 3.2 – Phaco Handpiece Assembly 1. Test Chamber 2. Infusion Sleeve 3. Handpiece with Tip 4. Attach the connector end of the handpiece to the phaco receptacle on the front of the WHITESTAR SIGNATURE™ System. Make sure there is no moisture on the connectors prior to connecting. Moisture prevents the handpiece from operating properly. Figure 3.3 – Ellips™ Handpiece Note: The Ellips™ handpiece can be used with WHITESTAR® Technology and Ellips™ Technology phaco settings. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 3-17 3 • System Setup Irrigation/Aspiration Handpiece 1. Assemble the SOLO™ Irrigation/Aspiration (IA) Handpiece by attaching the infusion sleeve. Note: The infusion sleeve and the test chamber are provided in the FUSION™ Tubing Pack. The LAMINAR™ Flow 20 ga. infusion sleeves can also be used and are available with the OPOS20L or any 20 ga. LAMINAR™ Phaco Tip. Figure 3.4 – IA Handpiece Assembly 1. Infusion Sleeve 2. SOLOTM Straight Tip 3. Handpiece 4. SOLOTM Curved Tip 5. SOLOTM 45o Silicone Sleeve Tip Load the FUSION™ Tubing Cassette 1. Open the tubing pack packaging. 2. Install the FUSION™ cassette into the side receptacle, as shown below. 3. Make sure that the drainage bag is properly attached to the cassette. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 3-18 3 • System Setup Figure 3.5 – Loading the FUSION™ Tubing Cassette Note: Press the button above the cassette to remove the cassette. Setup Completion IMPORTANT! Before you insert the spike into the bottle, shake the irrigation drip chamber at the end of the irrigation tubing to confirm that the irrigation valve moves. If the valve does not rattle, the valve cannot operate properly and irrigation cannot flow. 1. Place a new bottle of balanced salt solution on the top of the system console. 2. Insert the drip chamber spike into the balanced salt solution bottle. 3. Hang the balanced salt solution bottle from the Programmable IV Pole and squeeze the drip chamber. 4. Fill the drip chamber with fluid to the half-full level. The Programmable IV Pole moves to the appropriate height automatically. 5. Raise or lower the pole if needed. Use the IV pole Up and Down arrows on upper right of the touch screen. You can also use the Up/Down switch on the console. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 3-19 3 • System Setup Figure 3.6 – System Setup 6. Connect the IA tubing to the desired handpiece. 7. Insert the male luer end of the irrigation tubing into the phaco handpiece. 8. Attach the female luer fitting end of the aspiration tubing to the phaco handpiece. Note: To protect the patient from contamination, use only: • sterile tubing sets • sterile irrigation fluid • sterile handpieces Figure 3.7 – Phaco Handpiece Connections WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 3-20 3 • System Setup Diathermy 1. Connect the diathermy cord to the Diathermy Forceps or Pencil Probe. 2. Connect the diathermy cord to the diathermy receptacle on the front panel. Figure 3.8 – Diathermy Forceps Figure 3.9 – Diathermy Pencil Note: Other diathermy accessories are regionally available. Contact your AMO representative. Vitrectomy If vitrectomy is indicated during surgery: 1. Connect the AMO® Vitrectomy Cutter as shown below. Vitrectomy requires the following components: • IA Tubing (from FUSION™ Tubing Cassette) • Vitrectomy Cutter • Vitrectomy Infusion Sleeve, or a 23 Gauge Limbal Infusion Needle, if desired. 2. Assemble the handpiece using the instructions provided with the vitrectomy cutter. Figure 3.10 – Vitrectomy Cutter 3. Attach the connector end of the vitrectomy cord to the vitrectomy receptacle on the front panel. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 3-21 3 • System Setup Pre-Operative Sterilization The Instrument Sterilization Procedures in Chapter 9, “Care and Cleaning” identify the WHITESTAR SIGNATURE™ System instruments that must be sterilized prior to each surgical case. The recommended sterilization techniques, times and temperatures are given in Chapter 9, “Care and Cleaning”. AMO recommends that you follow the sterilization guidelines to maximize the life of your WHITESTAR SIGNATURE™ System instruments. Footpedal The footpedal controls all of the WHITESTAR SIGNATURE™ System functions, therefore, it is essential that you understand the footpedal operation. The System software automatically detects if a footpedal and what type of footpedal is connected during power up. The footpedal settings and adjustments can be selected and preset for the footpedal in the Configuration screen. Instructions for the footpedal settings are given in Chapter 5, “Anterior Segment Surgery Operating Modes”. The footpedal housing incorporates a handle, making the footpedal easy to grip for repositioning and storage. The Footpedal cable attaches to the footpedal connector on the rear of the console. The Advanced Control Pedal (dual linear) can also be setup with a wireless connection. Note: You must NEVER handle the footpedal by the cable. WARNING: Use only NiMH type batteries in the wireless Advanced Control Pedal. Figure 3.11 – Footpedal - Single Linear WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 3-22 3 • System Setup Figure 3.12 – Footpedal - Advanced Control Pedal (Dual Linear) Footpedal Operation The footpedal has three active “PITCH” ranges, which are referred to as Positions 1, 2 and 3. Position 0 is the Off position, and Position 3 is the fully pressed position. The ranges are shown below. The Advanced Control Pedal has two Yaw switches. Figure 3.13 – Footpedal “Pitch” and “Yaw” Positions 1. Pitch Toe Down/Up Configurable Ranges 2. Yaw Toe Right/Left Configurable Ranges The footpedal position determines the function that is delivered by the handpiece, which depends on the mode selected on the touch screen. When the footpedal has been connected, place your foot on the pedal and press to the desired position. The footpedal settings and programming are addressed in Chapter 5, “Anterior Segment Surgery Operating Modes”. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 3-23 3 • System Setup Note: Four to six minutes after the system is shutdown and power is turned off, the wireless footpedal goes into a power-save mode. To turn on the Wireless Footpedal after you start up the system, touch the Wake-up button. Reflux Reflux is the controlled backflow of fluid through the aspiration port of the handpiece. Reflux is used to gently release or dislodge unwanted material from the handpiece tip. Reflux can also be used to “tent” the incision site to allow easier tip insertion. Reflux pressure depends on bottle head pressure (IV pole height and gravity) for the FUSION™ Fluidics pack (OPO70), and as such, is not intended to clear a clogged handpiece. However, reflux can be used to identify a blockage. The reflux action can be programmed on any available footpedal switch. This causes fluid to be expelled from the aspiration line into or towards the eye. The reflux is active until the footpedal switch is released. The FUSION™ Fluidics pack (OPO70): • allows an inter-connection of the irrigation line to the aspiration line, so that sterile balanced salt solution can enter the aspiration line. • has no time restriction for Reflux as there is no pump reversal The DP pack (OPO71): • includes support for the vacuum tank used in the Venturi vacuum system • does not support inter-connecting the irrigation line to the aspiration line. Therefore, only previously aspirated fluid is being refluxed. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 3-24 3 • System Setup Programmable IV Pole The Programmable IV Pole is controlled by the Up and Down arrows on the upper right of the touch screen, next to the bottle height indicator. The buttons on the remote control and the switch on the side of the console can also be used to control the IV Pole. These controls are used to raise and lower the pole, and the height is indicated in the Programmable IV Pole screen. The Programmable IV Pole moves at a rate of approximately 6 cm (2 inches) per second. The Programmable IV Pole is adjustable from 0 to 104 centimeters, and can be set for either inches or centimeters. The height measurement is relative to the distance from the irrigation valve to the center of the drip chamber. The Programmable IV Pole height for each fluidic mode or submode (PHACO, IA, VIT) is saved in the WHITESTAR SIGNATURE™ System memory. A Maximum IV Pole height can be set on the Diagnostics screen. When a surgery mode is selected, the Programmable Power IV Pole automatically moves to the preset height. To manually adjust the IV pole height, use the Up and Down arrows on the touch screen. Manual adjustments to the IV pole can also be made by pressing the rocker switch located on the side of the console. If a maximum height has been set, the IV pole will not move above that height. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 3-25 3 • System Setup Wireless Remote Control (Optional) The wireless remote control keypad can be used to operate the WHITESTAR SIGNATURE™ System. All Modes, Programs, Diagnostics and End Case can be accessed and adjustments to the settings can be made with the remote control. The buttons on the remote keypad work the same as the controls on the WHITESTAR SIGNATURE™ System touch screen. Figure 3.14 – Wireless Remote Control Module 1. Remote Backlight On 6. Mode Select 2. Reload 7. Mode Down 3. IV Pole Up 8. Navigation Up/Down 4. IV Pole Down 9. Navigation Left/Right 5. Mode Up 10. Select When not in use, store the Wireless Remote Control on the top of the system to charge the batteries. After you turn the system On, press the Remote Control Backlight button to activate the Remote Control. When the system is Off the Remote Control is in a power save mode. Note: After four to six minutes of idle time, the Remote Control goes into a powersave mode. To turn the Remote Control on, press the Backlight button. WARNING: DO NOT try to replace the Wireless Remote Control batteries. Call your AMO Technical Service representative to replace the batteries. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 3-26 3 • System Setup Figure 3.15 – Wireless Remote Control Module Storage Surgical Media Center (SMC) (Optional) The Surgical Media Center (SMC) is used to record the surgery and the instrument settings to be viewed at a later date and time. The surgery is displayed on a monitor with the instrument settings. The SMC hardware is connected to your WHITESTAR SIGNATURE™ System Communications port on the rear panel. (See Figure 3.1 Rear Panel Connections.) 1. To configure the Surgical Media Center, select: • Configuration • System Configuration • SMC WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 3-27 3 • System Setup Figure 3.16 – Surgical Media Center Pop-up Window 2. Use the Up and Down arrows to adjust the settings. Translucency is used to make the overlay (instrument settings) more or less opaque. Note: Press on the number in the control panel to open a numeric keypad and enter the required value. Press Enter on the Keypad pop-up window when you are finished. Figure 3.17 – Numeric Keypad Pop-up Window 3. Select the Recording Mode. Off, On, or Automatic. If the Recording Mode is On, the recording continues between cases. Automatic stops recording between cases. Note: The Footpedal Switch can be set up to activate the SMC Record function. 4. Press Finished to close the pop-up window. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 3-28 3 • System Setup Shutdown Sequence – Anterior Segment Surgery The following is a general overview of the steps to be taken to shut the System down after surgery: 1. Select End Case. 2. Select Shutdown. At the prompt, select Yes. 3. Wait for shutdown sequence to complete. 4. Turn the system Off at the back of the console. 5. Remove the power cord from the power outlet. 6. Wrap the excess power cord neatly around the cord wrap on the back of the console. 7. Place the footpedal in the storage area on the console. 8. Place the Wireless Remote Control on top of the console to charge. 9. Refer to Chapter 9, “Care and Cleaning”, Cleaning Procedures for additional information. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 3-29 4 EQUIPMENT OPERATION Display Screens and Controls Language Selection Startup Select Program and Install the FUSION™ Tubing Cassette Prime/Tune Verify Irrigation/Aspiration Balance Priming for Vitrectomy Selecting and Changing Mode Parameters WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 4-1 4 • Equipment Operation Display Screens and Controls The touch screen is designed to give you visual indication of the status of the control systems at all times. When a mode (DIA, PHACO, IA, or VIT) is selected, the current settings are shown on the screen. As adjustments to settings are made, the screen shows the changes. The screens and controls are shown below. Each Anterior segment surgery mode and submode has their own distinct screen setup: • Irrigation/Aspiration • Phaco without OCCLUSION MODE™ • Phaco with OCCLUSION MODE™ and/or CASE (FUSION™ MODE) • Phaco with Ellips™ technology • Vitrectomy • Diathermy Figure 4.1 – PHACO Screen Additionally, there are screens or sub-screens for: • Prime/Tune • End Case • Program • Sounds • Footpedal • Database • Diagnostics WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 4-2 4 • Equipment Operation Language Selection The WHITESTAR SIGNATURE™ System features a 17-language user interface. Before you proceed, select one of the languages for your touch screen and controls. (English is the default language). 1. To access the Select Language screen, from the main screen, select: • Configuration • System Configuration • Language 2. Select the desired language from the listing. 3. Press Yes at the confirmation pop-up. The screen automatically changes to the selected language. 4. Press Exit Settings to proceed with the selected language. Figure 4.2 – Language Screen Note: On any screen, if you press the screen about 25 times, the System changes to the default language (English).You must press the same spot on the screen. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 4-3 4 • Equipment Operation Startup After you have turned on the WHITESTAR SIGNATURE™ System, the system performs a series of Self Tests. Figure 4.3 – Self Test After start up, the screen shows the available Surgeons and Programs that can be selected. You can now select a Surgeon and a Program. A Program (or Surgeon Name) is a set of pre-established operating settings for each operating mode. The WHITESTAR SIGNATURE™ System allows you program up to a maximum of 50 Surgeon names, and 20 customized surgeon setups (programs) for each surgeon. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 4-4 4 • Equipment Operation Figure 4.4 – Select Surgeon Screen If Standard Surgeon is the only surgeon set up, this screen is not shown, and the System proceeds immediately to the tubing cassette installation screen. From the Main Menu you can: • Select a Surgeon/Program and begin surgery based on the values of that program • Enter the Settings (Configuration) page, where you can edit, add, or delete programs and setup operating parameters • Enter the End Case screen (Refer to Chapter 5, Anterior Segment surgery Operating Modes, End Case.) WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 4-5 4 • Equipment Operation Select Program and Install the FUSION™ Tubing Cassette After you select a surgeon, you must select a program from the surgeon's available programs. If this is the first time the system has been used, AMO Default Program is the only program that appears on the screen. The first program you create uses the AMO Default Program settings as a starting point. You can modify the settings and Save As a specific program or surgeon name. The system does not let you overwrite the AMO Default Program when you press SAVE. If a surgeon only has one program set up, this screen is not shown, and the System proceeds immediately to the tubing cassette installation screen for the type of program that is set up for that surgeon. The System automatically recognizes the type of tubing casette that is installed. Note: An asterisk next to a program name indicates that the surgeon as selected that program as their default program. Figure 4.5 – Select Program Screen WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 4-6 4 • Equipment Operation Figure 4.6 – Install Cassette Screen Prime/Tune Prime/Tune is required before surgery is performed to fill the IA tubing with fluid, perform a vacuum check and to test and characterize the phaco handpiece. You must Prime and Tune: • before each procedure • anytime the handpiece is reconnected • after you have inserted or replaced a tubing cassette Continuous Irrigation can be selected to allow fluid to free flow from the bottle in order to collect fluid. Note: Before you Prime and Tune, the Cup Fill feature can be used to fill cups. Use the Up and Down arrows to set the amount needed, either 30, 60 or 90 cc, to fill the cup and then press Start. The Cup Fill stops when the selected amount is dispensed or Stop is pressed. You can still use Continuous Irrigation to fill cups. IA Prime is designed for a procedure that does not require a phaco handpiece. Tune is designed for a quick tune of the phaco handpiece with an IA tubing set. Tune can be used if a phaco tip is replaced during a procedure. When you Bypass prime the overall fluidics prime sequence is shortened and the time to prime the WHITESTAR SIGNATURE™ System is reduced. Bypass can be used if Continuous Irrigation has been used or the I/A tubing was primed. If the I/A tubing was not properly primed, errors can occur. To access the Prime/Tune routines, press the Prime/Tune button. The main console shows the Prime/Tune screen with all prime and tune options. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 4-7 4 • Equipment Operation Note: Prime/Tune is a combination of Tune followed by IA Prime. Figure 4.7 – Prime and Tune Screen The WHITESTAR SIGNATURE™ System tracks the successful completion of the Prime and Tune cycle independently. In the event a retune is required (new tip, failed tune), only the Tune needs to be selected and run. CAUTION: THE PHACO HANDPIECE AND VITRECTOMY CUTTER MUST NEVER BE ACTIVATED WITH THE TIP IN THE AIR. EXPOSURE OF THE TIP TO AIR DRASTICALLY REDUCES THE USEFUL LIFE OF THE HANDPIECE. IF POWER IS TO BE INTRODUCED TO THE PHACO HANDPIECE OR VITRECTOMY CUTTER, THE TIP MUST BE IN A TEST CHAMBER FILLED WITH BALANCED SALT SOLUTION, IN A CONTAINER OF BALANCED SALT SOLUTION OR IN THE PATIENT’S EYE. Suggestions for Priming the Handpieces Always fill the test chamber completely prior to running the Prime/Tune Cycle. Do not lay the handpiece and the empty test chamber down and have the system fill the test chamber. This allows air to collect in the test chamber and can produce an error. To collect the balanced salt solution: 1. Use the test chamber, a medicine cup, or similar container. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 4-8 4 • Equipment Operation 2. Use the Up and Down arrows to increase or decrease the amount of the fluid needed. 3. Press Start to turn on Cup Fill. 4. Use Stop to turn off Cup Fill before the requested amount of fluid is dispensed. 5. Perform a full Phaco Prime/Tune. The Prime/Tune screen indicates the progress of the priming process. 1. Use the Cup Fill feature to fill the test chamber with fluid and to eliminate all air. If the test chamber is attached to the handpiece, remove the test chamber before you start the Cup Fill process. 2. Place the test chamber over the handpiece tip and the sleeve hub. 3. Press the Prime/Tune button, this starts the Prime and Tune sequences. • To perform a Prime only, press the Prime button. • To perform a Tune only, press the Tune button. 4. Make sure the movement of the IV pole is not blocked by low ceilings. 5. Watch the fluid fill the drip chamber. The fluid moves toward the handpiece and fills the test chamber. 6. The touch screen indicates the progress of the Prime and Tune process. 7. As the tubing lines are filled, the system software performs functional checks. The checks include: • Monitoring for the presence of irrigation flow (bottle height) • Leaks (via vacuum rise checks) 8. If the phaco handpiece is plugged in and Prime/Tune or Tune was selected, the system automatically includes a handpiece tuning test concurrently with the prime cycle. • At the end of the priming sequence, the WHITESTAR SIGNATURE™ System makes an audible sound to indicate that Prime process is complete. • At the end of the phaco tuning test, the WHITESTAR SIGNATURE™ System makes an audible alert sound to indicate that tune process is complete. 9. To discontinue Prime or Tune during the process, select Cancel. 10. When Prime and Tune are complete, the system automatically proceeds to the preprogrammed submode or Phaco 1 operating mode. It is important that you verify the IA balance prior to operating. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 4-9 4 • Equipment Operation Verify Irrigation/ Aspiration Balance We strongly recommend verifying that Irrigation/Aspiration is balanced properly for the settings to be used in surgery. Figure 4.8 – Irrigation/Aspiration Balance Procedure To verify Irrigation/Aspiration balance: 1. In PHACO 1 mode, hold the handpiece at approximate patient eye level. 2. Occlude the aspiration line just below the handpiece, while you press and hold the footpedal in position 2. Make sure the footpedal is connected. (Refer to Chapter 3, System Setup, Footpedal.) 3. The actual vacuum level should rise to the preset level. 4. Release the aspiration line and watch the test chamber to make sure that the test chamber does not collapse. A slight shallowing of the test chamber is normal. 5. If the test chamber collapses, raise the IV bottle height or lower the vacuum setting. 6. Pinch the irrigation tubing at the handpiece and watch for the test chamber to collapse. 7. Release the irrigation line and the test chamber should fill. 8. Press Reset in the upper left corner of the screen to open the Reset Timers pop-up window. Press Yes to reset the timers. You are now ready to begin surgery. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 4-10 4 • Equipment Operation Priming for Vitrectomy Before you perform vitrectomy, we recommend you prime the handpiece in order to reduce the chance of errors. Each time you select vitrectomy mode you are prompted to prime the vitrectomy handpiece. If you do not need to prime, press Bypass. To prime the handpiece: 1. 2. 3. 4. 5. Attach the irrigation and aspiration cassette pack tubing together. Press Prime on the Prime/Tune screen. Press the VIT button to enter VIT mode. Follow the instructions on the screen. Press Start Vit Prime. The screen closes automatically when the handpiece is primed. Note: If you must perform vitrectomy in the middle of phaco surgery, perform steps 3 through 5. Figure 4.9 – Vitrectomy Prime Procedure WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 4-11 4 • Equipment Operation Selecting and Changing Mode Parameters The system's graphical user interface (GUI) and touch screen is designed for ease-of-use, consistent application and maximum informational display during all operating modes. Your interface with the system requires only three basic steps, which apply to all of the selections, settings and operations. Once this basic organization is understood, you can move quickly and easily through all of the system functions and operations. The touch screen is organized into panels. The top panel shows current status, configuration options, the bottle height, and the footpedal icon. The left-side column lists the operating modes and submodes. The main panel that dominates the screen shows current operating levels for aspiration, vacuum and power. • To switch operating modes or submodes, press a button in the left panel. The control panels in the main panel show the operating levels for that mode. • To make basic changes to the settings, press the Up and Down arrows to increase or decrease a value. Note: Press on the number in the Settings control panel to open a numeric keypad and enter the required value. Refer to Figure 3.17 Numeric Keypad Pop-up Window. Press Enter to close the Keypad window. • To change other control panel settings, such as Panel or Linear power, press the Settings button on that control panel. A Settings window opens, and you can make your selections. Figure 4.10 – PHACO Mode Screen • To make overall changes to a program, press Configuration on the top panel. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 4-12 4 • Equipment Operation Figure 4.11 – Configuration Pop-up Window • Press Surgeons and Programs to access surgeon names and their associated program setups. Figure 4.12 – PHACO Submode Configuration Screen WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 4-13 5 ANTERIOR SEGMENT SURGERY OPERATING MODES Operating Mode Descriptions Fusion™ Fluidics Phaco Programming the Modes and Settings Anterior Segment – Recommended Settings OCCLUSION MODE™ Phaco Settings Passive Reflux Ellips™ Technology WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 5-1 5 • Anterior Segment Surgery Operating Modes Operating Mode Descriptions Diathermy While the system is priming, you can select the Diathermy (DIA) mode (a function which does not require irrigation and aspiration flow) and perform Diathermy procedures. This process is referred to as a Diathermy during Prime. Figure 5.1 – Diathermy Mode Screen If Diathermy is selected during Prime, the screen indicates the Prime/Tune status and any messages associated with the prime and/or tune. The WHITESTAR SIGNATURE™ System provides power for bipolar coagulation or diathermy. The amount of diathermy power is shown on the Diathermy screen. If Panel power is selected, you can increase or decrease power by pressing the Up or Down arrows on the Power control panel. If the Linear mode is selected, the power is controlled with the footpedal up to the maximum preset value. Note: Press on the number in the Settings control panel to open a numeric keypad and enter the required value. Refer to Figure 3.17 Numeric Keypad Pop-up Window. Press Enter when you are finished. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 5-2 5 • Anterior Segment Surgery Operating Modes Figure 5.2 – Prime/Tune in Diathermy Mode Using Diathermy To begin Diathermy: 1. On the left panel press DIA. 2. Press the desired DIA submode button (DIA 1 is selected by default). The elapsed DIA time is displayed in the upper left corner as “DT”. In the main panel, you can increase or decrease the power by pressing the diathermy Power Up or Down arrows. If Linear power is selected, you can use the footpedal to increase or decrease the power up to the maximum preset value. To change the power delivery, press Settings. The Settings window opens. Set the power delivery to Panel, Linear or Burst. Linear delivery is the default. • Panel – Diathermy power is delivered consistently at the power level (%) selected and indicated on the screen as Panel Maximum Power. • Linear – Diathermy power is delivered from 5% to the maximum selected value (Maximum Power) as the footpedal is pressed. • Burst – Diathermy is delivered as a single 150 ms pulse, at the selected power, as the footpedal is pressed. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 5-3 5 • Anterior Segment Surgery Operating Modes Figure 5.3 – Diathermy Power Submode To set the submode parameters: 1. Make the desired settings to the DIA 1 values 2. Press the DIA 2 button to set the parameter values. 3. Change the parameter values for DIA 2. 4. After the submode (Program submode DIA 1, DIA 2) parameters are set, you can press another mode button in the left panel to program PHACO, IA, or VIT modes. 5. To access the SAVE buttons and save the submode settings, press End Case in the top panel if no other changes are needed and save the settings. Irrigation/Aspiration Aspiration flow is necessary to remove the emulsified cataract material from the eye. An irrigation supply is necessary to replace fluid removed by aspiration of cortical material and fluid lost to leakage from the incision. This fluid balance maintains the anterior chamber during surgery. Irrigation is controlled by gravity. The flow rate of irrigation solution through the irrigation sleeve on the phaco tip is determined by the height of the drip chamber (head pressure). The drip chamber hangs from the bottle on the Programmable IV Pole. AMO recommends that at the start of a procedure, the irrigation solution level in the drip chamber be located approximately 65–70 cm above the patient's eye level. To increase irrigation pressure, the IV bottle is raised. To decrease pressure, the bottle is lowered. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 5-4 5 • Anterior Segment Surgery Operating Modes The irrigation tubing runs through the tubing cassette and irrigation is controlled by the footpedal. When the footpedal is pressed, the pinch valve is opened and the irrigation fluid flows. Irrigation runs in footpedal Positions 1, 2 and 3. To program IA submodes: 1. On the left panel, press IA. 2. Select the desired IA submode. IA 1 is selected by default. 3. Press the Up or Down arrows in the control panels on the main panel to increase or decrease Aspiration Rate or Vacuum. Note: If the Venturi pump is On, only the Vacuum Settings are shown. To turn the Venturi pump setting on, use the IA Submode Configuration screen. 4. Press the Settings button in the control panels on the main panel to change Aspiration Mode or Vacuum Mode, 5. Press Finished to close the Settings window. 6. After all the submodes are programmed, select another mode. 7. If no other changes are needed press End Case to access the SAVE buttons and save the settings. Figure 5.4 – Irrigation/Aspiration Mode WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 5-5 5 • Anterior Segment Surgery Operating Modes Continuous Irrigation Continuous Irrigation is designed for collection of balanced salt solution for use during the case. This function opens the irrigation valve for fluid collection independent of the footpedal or prime cycle. To activate Continuous Irrigation: 1. On the side panel, press the Continuous Irrigation button. This opens the valve and starts the flow of irrigation fluid. 2. Press Continuous Irrigation again to deactivate the continuous irrigation. Figure 5.5 – Continuous Irrigation Phacoemulsification The purpose of phacoemulsification or PHACO is to emulsify the lens material. The phacoemulsification (phaco) handpiece provides ultrasonic energy, irrigation and aspiration simultaneously so that the lens material is extracted as it is emulsified. The phacoemulsification handpiece has a hollow needle that vibrates longitudinally at an ultrasonic frequency or a blend of longitudinal and transversal, if using the Ellips™. The rapid movement of the needle and the resulting cavitational energy disintegrates the cataract on contact. The debris is removed by suction through the hollow needle (aspiration). The resulting loss in volume of the anterior chamber is compensated by incoming balanced salt solution (irrigation). WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 5-6 5 • Anterior Segment Surgery Operating Modes PHACO Submodes There are four PHACO submodes. Within each submode, there are programmable parameters for Unoccluded Phaco, and Occluded Phaco, and CASE settings. Phaco Power is a combination of stroke length, frequency and handpiece efficiency. A preset power setting of 30% using linear control allows you the ultimate control during phaco. Adjustments to phaco power depend on factors that include nuclear density, your preferences and your experience. Phacoemulsification mode lets you set four submodes with different settings. You can adjust the individual parameters of each submode. Figure 5.6 – PHACO Submodes For each PHACO submode, you can change the following settings: • Aspiration Rate • Vacuum • Power Before phacoemulsification, you must complete the steps to verify the Irrigation and Aspiration balance, as recommended in the Irrigation/Aspiration section in this chapter. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 5-7 5 • Anterior Segment Surgery Operating Modes Using PHACO 1. Press PHACO. 2. Press Phaco 1, Phaco 2, Phaco 3, or Phaco 4 to select the submode. The main panel shows all of the settings for Aspiration Rate, Vacuum and Power. Each submode has different default settings. 3. Press the footpedal to activate phacoemulsification. The Aspiration Rate, Vacuum and Power control panels indicate the associated levels throughout the procedure. The Footpedal icon in the upper right corner of the screen shows the position of the footpedal. How to Program PHACO 1. Press the PHACO button. 2. Press the desired submode button. Phaco 1 is selected by default. Note: You can set your Initial Mode/Submode on the Phaco Configuration screen. The Initial Mode/Submode is then your default setting. (Refer to Program Configuration, in this chapter.) 3. In the control panels in the main panel, click the Up or Down arrows to increase or decrease Aspiration Rate, Vacuum, or Power. Note: If the Venturi pump is On, only the Vacuum and Power Settings are shown. CASE is not accessible when the Venturi pump is On. 4. Repeat for each submode you want to program. 5. If OCCLUSION MODE™ Phaco or CASE is desired, press in the left column to activate the FUSION™ Mode screen. When OCCLUSION MODE™ Phaco is active, the On button is green. Figure 5.7 – Fusion™ Fluidics Screen WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 5-8 5 • Anterior Segment Surgery Operating Modes If you use CASE or OCCLUSION MODE™ Phaco, you can set different values for both Occlusion Threshold and Max Vacuum. Refer to Fusion™ Fluidics Phaco for programming CASE and OCCLUSION MODE™ Phaco modes. After all four PHACO submodes are programmed; press a mode button to select another mode. If no other changes are needed press End Case to access the SAVE buttons and save the settings. WHITESTAR® Technology The WHITESTAR® Technology can be applied in any phaco power delivery mode. This technology is an advanced phacoemulsification power mode that delivers finely modulated pulses of energy interrupted by extremely brief cooling periods. This technology is available in Linear or Panel mode. When the WHITESTAR® delivery mode is turned on, either screen, along with the WHITESTAR® Duty Cycle. or appears on the touch Figure 5.8 – WHITESTAR® Technology WHITESTAR® Duty Cycles are expressed as Pulse Time On/Pulse Time Off, to achieve a desired Duty Cycle. For example, the Duty Cycle setting 6/12 means that the pulse time On is 6 ms, and the pulse time Off is 12 ms, resulting in a 33% duty cycle. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 5-9 5 • Anterior Segment Surgery Operating Modes Table 5.1 – WHITESTAR® Technology Parameter Settings Setting Pulse Off Time (ms) 12 Duty Cycle 6/12 Pulse On Time (ms) 33% Pulse Rate (pps) 55 4/8 33% 83 6/4 60% 100 6/8 43% 71 8/4 67% 83 4/24 24 14% 35 6/28 28 18% 29 6/24 24 20% 33 8/24 24 25% 31 6/18 18 25% 41 Figure 5.9 – Duty Cycle When the Variable WHITESTAR® Technology is used, different duty cycles are applied as the footpedal moves through the power delivery zone. The zone is divided into four equal size quadrants, and a different duty cycle can be applied in each quadrant. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 5-10 5 • Anterior Segment Surgery Operating Modes Figure 5.10 – Variable WHITESTAR® Technology Footpedal Positions and Duty Cycles 1. Footpedal Position 3 2. WHITESTAR® Duty Cycle The WHITESTAR SIGNATURE™ System maintains duty cycles to be used with Variable WHITESTAR® – Variable WS. Variable WS contains the four duty cycles that are used in the different quadrants. You can also use the sliding adjustments to create Custom WHITESTAR® duty cycles for WS. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 5-11 5 • Anterior Segment Surgery Operating Modes Figure 5.11 – Duty Cycles for Variable WS WHITESTAR® ICE Technology Pulse Shaping 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. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 5-12 5 • Anterior Segment Surgery Operating Modes Figure 5.12 – WHITESTAR® ICE Technology Pulse Shaping 1. Kick Amplitude 3. Burst Width 2. 1 Millisecond Kick 4. Phaco Power Level To access the WHITESTAR® ICE Technology settings: 1. Press the Power Settings button. 2. 3. 4. 5. Press the WHITESTAR mode button. Press On for Pulse Shaping. Press Edit to access the Pulse Shaping parameter settings. Press Finished to close the screen. Continue to press Finished to return to the main screen. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 5-13 5 • Anterior Segment Surgery Operating Modes Figure 5.13 – Pulse Shaping Screen There are four settings for WHITESTAR® ICE Pulse Shaping: • Low Power Limit • High Power Limit • Percent Kick Low End of Range • Percent Kick High End of Range The Low and High Power Limit settings define the range over which pulse shaping is applied. When the applied Phaco Power is outside of these limits, no pulse shaping is applied. The Percent Kick settings determine the amplitude, or amount of Phaco Power “kick” that is applied in the first millisecond of Phaco Power application, either in the low end or the high end of the power range. As the Phaco power increases from the Low Power limit to the High Power Limit, the percentage of kick is interpolated for the power ranges in between the two limits. As an example, if a small kick setting is established for the Low End of the range and a large kick setting is established for the High End of the range, the kick percentage gradually increases as the Phaco Power increases. When the Percent Kick at the Low End is the same as the High End, then the kick remains constant throughout the Low to High range. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 5-14 5 • Anterior Segment Surgery Operating Modes Fusion™ Fluidics Phaco Fusion™ Fluidics Phaco is an intelligent vacuum monitoring system used to regulate the maximum allowable vacuum that is experienced following an 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 cause a postocclusion 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. It is possible to have a different maximum vacuum setting when the needle is occluded than when the needle is not occluded. The power modulation of the phaco handpiece can be programmed to automatically change when the phaco tip changes from an unoccluded condition to an occluded condition. Figure 5.14 – Fusion™ Fluidics Phaco 1. CASE Vacuum 2. Upper Threshold 3. Lower Threshold 4. Vacuum Level crosses Upper Threshold. 5. Phaco activated. 6. Up Time 7. Vacuum Level 8. Vacuum. 9. Time. 10. Max Vac The CASE screen shows the settings as a graph. To access the OCCLUSION MODE™ Phaco and CASE settings: 1. Press the WHITESTAR SIGNATURE™ System button from the PHACO mode screen. Rx Only – Z370147 Rev. C 1108 5-15 5 • Anterior Segment Surgery Operating Modes Figure 5.15 – Fusion™ Fluidics Phaco Screen 2. Press the On button to turn CASE mode on. Note: If the Venturi pump option is On, you cannot access the Fusion™ Fluidics screen. There is no Occlusion Mode or CASE Mode with Venturi. 3. Use the Up and Down arrows at the bottom of the screen to adjust the: • CASE Vacuum (CASE) – This is the optimum occlusion vacuum setting • Upper Threshold (Up) – This is the maximum threshold vacuum setting, which is maintained for the amount of time defined by the Up Time Threshold. • Lower Threshold (Down) – After the occlusion is cleared, the vacuum is reduced to the lower vacuum threshold setting to allow the occlusion to be safely cleared, and then gradually returned to the previous levels. 4. Use the Right and Left arrows in the graphic to change the Up Time Threshold. The Up Time Threshold is the maximum time that the maximum threshold vacuum is maintained. 5. Press Finished to close the screen Use the Fusion™ Fluidics screen to turn OCCLUSION MODE™ Phaco Off or On. When OCCLUSION MODE™ Phaco is On, the main PHACO operating screen provides for alternative Aspiration, Vacuum and Phaco Power settings that are used when an occlusion is detected. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 5-16 5 • Anterior Segment Surgery Operating Modes Figure 5.16 – PHACO Screen Vitrectomy The WHITESTAR SIGNATURE™ System uses a pneumatic guillotine vitrectomy cutter. The handpieces are designed for cutting vitreous during anterior segment surgery and operate in conjunction with the Irrigation/Aspiration mode. The cutting speed can be changed on the touch screen. There are four adjustments related to the Vitrectomy mode: • Aspiration Rate • Vacuum • Cut Rate • Footpedal CAUTION: THE PHACO HANDPIECE AND VITRECTOMY CUTTER MUST NEVER BE ACTIVATED WITH THE TIPS IN THE AIR. EXPOSING THE TIP TO AIR DRASTICALLY REDUCES THE USEFUL LIFE OF THE HANDPIECE. IF POWER IS TO BE INTRODUCED TO THE PHACO HANDPIECE OR VITRECTOMY CUTTER, THE TIPS MUST BE IN A TEST CHAMBER FILLED WITH A BALANCED SALT SOLUTION, IN A CONTAINER OF BALANCED SALT SOLUTION OR IN THE PATIENT’S EYE. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 5-17 5 • Anterior Segment Surgery Operating Modes Using Vitrectomy In the left panel, press VIT 1 or VIT 2 to select a submode. VIT 1 is selected by default. Note: Each time you select the vitrectomy mode you are prompted to prime the vitrectomy handpiece. Refer to Chapter 4, Equipment Operation, Priming for Vitrectomy for detailed information. Figure 5.17 – Vitrectomy Mode Screen 1. In the main panel, press the Up or Down arrows to increase or decrease the Aspiration Rate, Vacuum, or Cut Rate. Note: If the Venturi pump is On, only the Vacuum and Cut Rate Settings are shown. 2. To program the footpedal, go to Configuration, Surgeons and Programs, Foot Pedal, Configuration, VIT. 3. Select a Submode to program. 4. Edit the footpedal settings as needed. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 5-18 5 • Anterior Segment Surgery Operating Modes Figure 5.18 – Single Linear Foot Pedal Settings Screen Figure 5.19 – Dual Linear Foot Pedal Settings Screen 5. When finished, press Exit Settings. 6. If no other changes are needed, press End Case to access the SAVE buttons and save the settings WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 5-19 5 • Anterior Segment Surgery Operating Modes Footpedal Vitrectomy Modes The footpedal mode selection must be made for ICA, IAC, or Side vitrectomy (VIT), which determines how the vitrectomy cutter is activated as the footpedal is pressed from Positions 1 through 3. Use the left side switch to activate the cutter at the panel rate for Side VIT only. Table 5.2 Vitrectomy Single Linear Footpedal Modes Footpedal Positions Vitrectomy Footpedal Modes ICA IAC Side VIT Irrigation Irrigation Irrigation Irrigation/Cut Irrigation/ Aspiration Irrigation/ Aspiration Irrigation/Cut/ Aspiration Irrigation/ Aspiration/Cut Irrigation/ Aspiration Table 5.3 Vitrectomy Advanced Control Pedal (Dual Linear) Modes Footpedal Positions Vitrectomy Footpedal Modes ICA IAC Side VIT Irrigation Irrigation N/A Irrigation/Cut Irrigation/ Aspiration N/A Yaw Aspiration Cut N/A WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 5-20 5 • Anterior Segment Surgery Operating Modes Programming the Modes and Settings Program Configuration These programmed settings allow for the selection of operational features and options pertinent to general operation for each mode and submode, the footpedal, system sounds and the system database. When the AMO Default Program is selected, all of the modes and submodes are preset. Although these settings can be changed, they cannot be saved. Use the defaults as a source to your system settings. All default settings can be easily viewed on the Mode Configuration screens. Figure 5.20 – PHACO Program Screen WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 5-21 5 • Anterior Segment Surgery Operating Modes AMO Default Setups Sounds Table 5.4 – WHITESTAR SIGNATURE™ System Default Settings Specific to each surgeon program/setup Sounds Available Settings High Vacuum On, Off AMO Default Settings On Mode Change Off, Tone, Voice Voice On Submode Change Off, Tone, Voice Voice On Value Change On, Off Voice On Activity Confirmation On, Off Voice On Vacuum Off–10 Diathermy 5–10 Phaco Power Off–10 Off Error 5–10 Irrigation Off-10 Key Press Off–10 Speech Off–10 CASE Activation 0–10 Master Volume 0–10 10 WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 5-22 5 • Anterior Segment Surgery Operating Modes Footpedal – AMO Default Settings The AMO Default footpedal settings for each operating mode are shown on the System's Summary Screen. Figure 5.21 – Single Linear Footpedal Summary Settings WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 5-23 5 • Anterior Segment Surgery Operating Modes Table 5.5 – Footpedal Threshold AMO Default Settings Footpedal Type Single Linear Parameter Available Settings 1–100% AMO Default Settings P1=5% P2=30% P3=60% Switch1= * Switch 2= * Switch1=Off Switch 2=Off Right= * Left= * Right=Off Left=Off Feedback On, Off Off Primary Yaw Reflux Pitch Region 1-100% P1=5% P2=30% P3=60% Yaw Position 5-100% Left=50% Pitch Regions Switch Position Advanced Control Pedal (Dual Linear) Right=50% Switch Position Switch1= * Switch 2= * Switch1=Off Switch 2=Off Yaw Threshold 5% - 100% 5% Feedback On, Off Off *Switch Assignments Surgeon Program Up Next Active Mode Bottle Down Surgeon Program Down Previous Major Mode Previous Sub Mode Next Sub Mode Reflux Continuous Irrigation Toggle Case (Phaco Only) Single Vit Cut (Vitrectomy Only) Next Major Mode Toggle SMC Record 1-Touch Up (Phaco Only) Previous Active Mode Bottle Up 1-Touch Down (Phaco Only) Table 5.6 – Diathermy – AMO Default Settings Parameter Available Settings AMO Default Settings DIA 1 DIA 2 Max Power 5–100% 30% 30% Power Delivery Type Linear, Burst, Panel Linear Burst Initial Mode/ Submode Any of the Submode Names Phaco 1 Phaco 1 WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 5-24 5 • Anterior Segment Surgery Operating Modes Table 5.7 – I/A – AMO Default Settings Parameter Available Settings AMO Default Settings IA1 IA2 IA3 Continuous Irrigation On, Off Off Off Off Pump Selection Venturi Peristaltic Peristaltic Peristaltic Peristaltic Bottle Height 0–104 cm 0–42 inches 76 cm 30 inches 50 cm 20 inches 50 cm 20 inches Max Vacuum 0–650 mmHg 500 mmHg 500 mmHg 15 mmHg Max Aspiration/ Mode (Peristaltic) 0–60 cc/min 26 cc/min Panel 26 cc/min Linear 6 cc/min Panel Peristaltic Pump Ramp Threshold 10–100% 80% 80% 80% Venturi Pump On, Off Off Off Off Passive Reflux (Fusion™ Fluidics Pack) Yes, No Yes Yes Yes Passive Reflux (Fusion™ Dual Pump Pack) Yes, No Yes Yes Yes Initial Mode/ Submode Any of the Submode Names Phaco 1 Phaco 1 Phaco 1 Fluidic Mode Panel, Linear Panel Aspiration Linear Aspiration Panel Aspiration Linear Vacuum Panel Vacuum Linear Vacuum WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 5-25 5 • Anterior Segment Surgery Operating Modes Table 5.8 – PHACO – AMO Default Settings Parameter Available Settings AMO Default Settings Phaco 1 Phaco 2 Phaco 3 Phaco 4 Bottle Height 0–104cm 0–42 inches 66 cm 26 inches 76 cm 30 inches 76 cm 30 inches 76 cm 30 inches Continuous Irrigation On, Off Off Off Off Off Pump Selection Venturi Peristaltic Peristaltic Peristaltic Peristaltic Peristaltic Max Vacuum Peristaltic 0–650 mmHg 75 mmHg 300 mmHg 400 mmHg 350 mmHg Max Vacuum Venturi 0-600 mmHg 75 mmHg 300 mmHg 400 mmHg 350 mmHg Venturi Pump On, Off Off Off Off Off Passive Reflux Yes, No Fusion™ Fluidics Pack Yes Yes Yes Yes Fusion™ Dual Pump Pack Yes Yes Yes Yes Initial Mode/ Submode Any of the Submode Names Phaco 1 Phaco 1 Phaco 1 Phaco 1 Max Flow/ Aspiration Rate, Unoccluded (Peristaltic) 10–60 cc/min 18 cc/min 24 cc/min 18 cc/min 24 cc/min Fluidics Mode Panel, Linear Panel Aspiration, Linear Vacuum Panel Aspiration, Panel Vacuum Panel Aspiration, Linear Vacuum Panel Aspiration, Linear Vacuum Occlusion Threshold 0–Max Vac. 25 mmHg 140 mmHg 60 mmHg 80 mmHg OCCLUSION MODETM Phaco On, Off Off On On Off CASE Mode On, Off Off Off On On CASE Upper Threshold. 0–Max Vac. 100 mmHg 250 mmHg 325 mmHg 300 mmHg CASE Lower Threshold. 0–Max Vac. 70 mmHg 175 mmHg 200 mmHg 200 mmHg Up Time 0–2000 ms 300 ms 300 ms 300 ms 300 ms CASE Vac 120–650 mmHg 85 mmHg 225 mmHg 250 mmHg 250 mmHg CASE One-Touch -2, -1, STD, +1, +2 STD STD STD STD Peristaltic Pump Ramp 10–100% 50% 60% 50% 70% Power Delivery Mode (Unoccluded and Occluded) Continuous Short Pulse Long Pulse Low Power Pulse High Power Pulse Single Burst Multi-Burst Continuous Burst Continuous Continuous Continuous Continuous Short Pulse Rate 1–14 pps 6 pps 6 pps 6 pps 6 pps Long Pulse Rate 1–6 pps 4 pps 4 pps 4 pps 4 pps WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 5-26 5 • Anterior Segment Surgery Operating Modes Parameter Available Settings WHITESTAR® Technology Duty Cycles 2–30 On Time AMO Default Settings 6/12 (33%) 6/12 (33%) 6/12 (33%) 6/12 (33%) 2–30 Off Time Predefined: 6/ 12, 4/8, 6/4, 6/ 8, 8/4, 4/24, 6/ 28, 6/24, 8/24, 6/18 Max Aspiration Rate Occluded 10–60 cc/min 18 cc/min 28 cc/min 14 cc/min 24 cc/min Max Phaco Power Occluded 0–100% 40% 30% 10% 40% Max Ellips™ Phaco Power Occluded On, Off Off Off Off Off Max Phaco Power Unoccluded 0–100% 40% 20% 5% 30% Max Ellips™ Phaco Power Unoccluded On, Off Off Off Off Off Power Delivery Type Occluded Linear, Panel Linear Linear Linear Linear Table 5.9 – Vitrectomy – AMO Default Settings Customized to Each Surgeon Program/Setup AMO Default Settings Parameter Available VIT 1 VIT 2 Settings 30 cm 30 cm Bottle Height 0–104 cm 12 inches 12 inches 0–42 inches Continuous Irrigation On, Off Off Off Pump Selection Venturi Peristaltic Peristaltic Peristaltic Max Vacuum/Mode (Peristaltic) 0–650 mmHg Panel, Linear 225 mmHg Panel 225 mmHg Panel Max Aspiration Rate/ Mode 0–60 cc/min Panel, Linear 18 cc/min Panel 12 cc/min Panel Fluidic Mode Panel, Linear Panel Aspiration Panel Aspiration Panel Vacuum Panel Vacuum Cut Rate 50–2500 cpm 250 cpm 450 cpm Footpedal Mode ICA, IAC ICA IAC Pump Ramp Threshold 10 - 100% 100% 100% Venturi Pump On, Off Off Off WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 5-27 5 • Anterior Segment Surgery Operating Modes Customized to Each Surgeon Program/Setup AMO Default Settings Parameter Available VIT 1 VIT 2 Settings Passive Reflux Yes, No Yes Yes (Fusion™ Fluidics Pack) Passive Reflux (Fusion™ Dual Pump Pack) Yes, No Yes Yes Initial Mode/ Submode Any of the Submode Names Phaco 1 Phaco 1 Aspiration Rate The Aspiration Flow Rate is the speed at which material is removed from the eye through the aspiration tubing. A pump provides the necessary aspiration flow to withdraw fluid and lens material from the eye chamber through the handpiece. With this aspiration flow system, the vacuum builds when the aspiration port is blocked or occluded. The vacuum reduces as the occlusion clears. You can adjust the rate in 1 cc increments from 0 to 60 cc per minute. You can also choose Panel or Linear flow. The flow rate decreases as the vacuum approaches maximum. To adjust the flow rate: 1. On the Aspiration Rate control panel, press the Up or Down arrows to increase or decrease the aspiration rate from 0 to 60 cc per minute. 2. Press the Settings button to select Linear or Panel aspiration flow. The Settings panel appears. 3. Press the Linear or Panel button. The Linear vacuum rate is linear with respect to the footpedal position. As the footpedal is pressed through Position 2, the vacuum level travels between 0 mmHg and the maximum preset level as occlusions at the aspiration port occur. The actual vacuum level is indicated by the vacuum progress shown on the screen. The Panel vacuum rate provides a continuous evacuation at the established vacuum rate. The vacuum builds only when the footpedal is in Position 2 and an occlusion in the aspiration port is created. 4. Press Finished to close the window. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 5-28 5 • Anterior Segment Surgery Operating Modes Vitrectomy Cutting Rates Note: Each time you select the vitrectomy mode you are prompted to prime the vitrectomy handpiece. Refer to Chapter 4, Equipment Operation, Priming for Vitrectomy for detailed information. You can vary the Vitrectomy Cut Rate of the vitrectomy cutter from 50-2500 CPM (cuts per minute) in increments of 50 CPM between 100–1000, and 100 CPM between 1000–2500 CPM. Some surgeons prefer a higher rate, which allows the surgeon to perform the same amount of cutting with smaller “bites” of vitreous. This minimizes motion and is gentle on the tissue. To adjust the cut rate 1. On the Cut Rate panel, press the Up or Down arrows to increase or decrease the cut rate. 2. Press Settings to select either Linear or Panel cutting methods. The Settings window opens. Note: Side Vit is only available for use with a single linear foot pedal. 3. Press Linear or Panel button. 4. Press Finished to close the window. Figure 5.22 – VIT Cut Rate WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 5-29 5 • Anterior Segment Surgery Operating Modes Footpedal Settings The System accommodates multiple configurations for setting footpedal operation. Each surgeon has one set of footpedal settings for all programs. The Switch Assignment screen opens when you select On for any of the switches on the Foot Pedal selection screens. The Switch Assignment screen allows you to make a selection for that switch. Footpedal Settings From the top panel of any operating screen, press Configuration. The program highlighted on the Main Menu is used. 1. Press Surgeons and Programs in the pop-up window. 2. In the side panel press Foot Pedal. Figure 5.23 – Foot Pedal Pitch Thresholds - Single Linear WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 5-30 5 • Anterior Segment Surgery Operating Modes Figure 5.24 – Foot Pedal Pitch Thresholds - Advanced Control Pedal (Dual Linear) 3. Adjust the Yaw Threshold percentage if the Advanced Control Pedal is used. 4. Adjust the Foot Pedal Pitch Threshold settings. 5. Turn the Foot Pedal Feedback On or Off. You can use the Foot Pedal Test button to test your settings. 6. Press Configuration. The Foot Pedal Settings options are shown. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 5-31 5 • Anterior Segment Surgery Operating Modes Figure 5.25 – VIT Foot Pedal Settings Advanced Control Pedal (Dual Linear) 7. Select the type of foot pedal. 8. Select the Primary Yaw. Each time you select the Assign Primary Yaw button, the selection is changed from left-to-right or right-to-left. 9. Select the operating modes for that surgery using the top Mode tabs and complete the footpedal setup for each mode (PHACO, IA, VIT, or DIA). The footpedal settings are shown in the center of the screen. Select Summary to view the footpedal settings for all of the modes. 10. Press each of the switches in any of the four modes. A pop-up window is shown for each switch. 11. Select the Switch Assignment from the list. Note: WHITESTAR Increment and WHITESTAR Decrement are used to increase or decrease the Duty Cycles during surgery. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 5-32 5 • Anterior Segment Surgery Operating Modes Figure 5.26 – Vitrectomy Switch Assignment Pop-up Window 12. Press Finished to close the window. 13. Press SAVE to retain the settings. Note: If you entered Configuration while in an Operating mode, press Exit Settings to return to the previous mode. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 5-33 5 • Anterior Segment Surgery Operating Modes Vacuum The vacuum is the force exerted on the aspirated fluid in the aspiration tubing. To make sure you have fluidic balance while in phacoemulsification, you can adjust the Max Vac from 0 to 650 mmHg (Peristaltic pump), as indicated on the Vacuum panel. 1. To adjust the vacuum settings: • To increase or decrease vacuum force, press the Up and Down arrows on the Vacuum panel. 2. To select Linear or Panel flow, press Settings. The Vacuum Settings pop-up window appears. 3. Press the Linear or Panel button. 4. Press Finished. The Linear flow increases from the minimum (0 cc per min) to the maximum preset flow rate as the surgeon presses the footpedal through Position 2. A higher flow rate (as delivered from the footpedal) results in a quicker vacuum rise time. A slower flow rate results in a slower vacuum rise time. The Panel flow provides a constant evacuation at the preset flow rate when the footpedal enters Position 2. End Case End Case is available in the top panel from any programming or surgical mode. End Case allows you terminate the programming session or surgical case. If changes were made to the program settings, you are prompted to SAVE the settings. Note: For ease of viewing, the EPT, Ellips EPT, UST and AVG times are shown in a large font size on the End Case window. The Ellips EPT is shown only when Ellips™ Technology is On. Program Note: SAVE, Save As, and Restore have the same functions on the Program Configuration screens. SAVE – Saves the changes to the existing Surgeon Name/Program. Save As – Saves the program changes (made to an existing program) to a new program name when you enter a program name. Restore – Erases any program changes and resets the values back to the last saved values. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 5-34 5 • Anterior Segment Surgery Operating Modes End Case Purge – Select Purge to remove all of the fluid from the irrigation and aspiration tubing before you remove the tubing cassette. Next Case – Select Next Case to install a new tubing cassette. Note: Use a new bottle of balanced salt solution at the start of each case. Figure 5.27 – End Case Screen The timers in the upper left corner indicate Effective Phaco Time (EPT), Ultrasonic (U/S) Time in Footpedal Position 3, and Ellips EPT if Ellips™ Technology is On. Effective Phaco Time is ultrasound time as a weighted total that takes into account the amount of power being used: • at 100% power: 1 sec. U/S Time = 1 sec. EPT • at 50% power: 1 sec. U/S Time = .5 sec. EPT Current Case Review Case – shows the graphical history of the surgery. (Refer to Figure 5.28 Review Case Screen.) 1. Select a shorter time interval to adjust the Time Line Duration and to see greater case details. For example, 10 Sec shows more detail than 15 Min. 2. Select a longer time interval for an overview of the surgery or sessions, such as 1 hour or 2 hours. This view provides less detail, but gives you a better indication of the trends over a period of time. Use the << or >> buttons to change the time intervals. You cannot use the arrow buttons when you view an active case. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 5-35 5 • Anterior Segment Surgery Operating Modes 3. Press the Select Review Case to select and view a specific surgical case. 4. Press Export to name and save the record to a USB device. Enter a name for the Case History. Note: Use only AMO recommended USB stick drives. 5. Use the Print to File to save the data to a file format. The Delete Record button removes the case from the Record database. 6. Select Finished to close the window. Figure 5.28 – Review Case Screen Continue Case – Select Continue Case to return to the current case, after you selected Review Case or Restore. Shutdown – Select the Shutdown button to turn the System Off. At the prompt, press Yes to complete the process. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 5-36 5 • Anterior Segment Surgery Operating Modes Anterior Segment – Recommended Settings Phaco Power You can adjust power from 0% to 100% in 5% increments for both Occluded and Unoccluded phaco tips. The large number in the power panel indicates the selected maximum Phaco Power. The phaco power can be either Linear or Panel. 1. Linear – Power is controlled with the footpedal, the power increases from 0%– 100% to the maximum preset level. When the footpedal is fully pressed, the power level is at the maximum preset level. The power increase is indicated by the power display bar. 2. Panel – Power is delivered consistently at the power level (%) indicated on the screen. The power level does not change when you press the footpedal. There are eight choices for delivery of phaco power: • Continuous • Short Pulse • Long Pulse • Low Power Pulse • High Power Pulse • Single Burst (Panel only) • Multiple Burst (Panel only) • Continuous Burst (Panel only) From the PHACO operating screen, press Settings and the Phaco Power selection screen appears. Figure 5.29 – Phaco Power Settings In addition to the eight Phaco Power modes, you can also select the WHITESTAR Mode. The WHITESTAR® Technology and Ellips™ Technology are discussed later in this section. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 5-37 5 • Anterior Segment Surgery Operating Modes Continuous Phaco Power Continuous Phaco Power delivers continuous, uninterrupted phaco power to the handpiece and requires no pulse rate setting. Figure 5.30 – AMO® Phaco Power Modes Short Pulse Phaco Power Short Pulse delivers Phaco in pulses of 50 ms when the footpedal is in Position 3. You can set this in a range of 1 to 14 pulses per second (pps). The actual number of pps is shown on the button to the right of the Short Pulse button. To set the Short Pulse range: 1. Press the button to the right of the Short Pulse button. A Settings pop-up window appears. 2. Press the Up or Down arrow to increase or decrease the pps from 1 to 14. 3. Press Finished to close the window. Long Pulse Phaco Power Long Pulse delivers Phaco in pulses of 150 ms when the footpedal is in Position 3. You can set this in a range of 1 to 6 pulses per second (pps). The actual number of pps is displayed on the button to the right of the Long Pulse button. To set the Long Pulse range: 1. Press the button to the right of the Long Pulse button. A Settings pop-up window appears. 2. Press the Up or Down arrow to increase or decrease the pps from 1 to 6. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 5-38 5 • Anterior Segment Surgery Operating Modes 3. Press Finished to close the window. Low Power Pulse Phaco Power Low Power Pulse generates short pulses of ultrasonic power in footpedal Position 3. When you press the footpedal, the pulses become longer and eventually blend together to become continuous phaco power. High Power Pulse Phaco Power High Power Pulse generates continuous Phaco Power in footpedal Position 3. When you press the footpedal, the continuous pulse changes into long pulses and then gradually changes to short pulses. Figure 5.31 – AMO® Phaco Burst Power Modes Single Burst Phaco Power (Panel Only) Single Burst delivers a single burst of ultrasonic power of 110 ms duration when you press the footpedal to Position 3. You must return to footpedal Position 2, pause for approximately one-half (.5) second, and then press the footpedal to Position 3 to obtain an additional burst of energy. Multiple Burst Phaco Power (Panel Only) Multiple Burst generates a burst of ultrasonic power of 110 ms duration, with additional bursts deployed beginning at approximately 1 burst per second when you press the footpedal to Position 3. The frequency of burst increases as you press the footpedal. At the maximum level of footpedal Position 3, the bursts are delivered at the rate of 4 bursts per second. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 5-39 5 • Anterior Segment Surgery Operating Modes Continuous Burst Phaco Power (Panel Only) Continuous Burst delivers a 110 ms ultrasonic burst duration. As you press the footpedal through Position 3, the bursts get closer together. At the maximum level of footpedal Position 3, the bursts blend together, and the power becomes continuous (at the preset power level). Override PHACO Submode Settings You can override the settings for a PHACO submode by selecting the submode, and either press the Up and Down arrows to increase or decrease Aspiration Rate, Vacuum, or Power settings, or press Settings on the control panels for Aspiration Rate, Vacuum, or Power. If you pressed the Settings button, the Settings pop-up window appears. Figure 5.32 – Override PHACO Submode Settings WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 5-40 5 • Anterior Segment Surgery Operating Modes OCCLUSION MODE™ Phaco Settings CASE Mode To access the OCCLUSION MODE™ Phaco and CASE settings: 1. Press the button from the PHACO operating screen. Figure 5.33 – CASE OCCLUSION MODE™ Phaco CASE maintains a stable chamber by detecting an impending occlusion break, and reducing the vacuum before occlusion surge can occur. When the occlusion is detected, the System waits long enough to allow the particle to be firmly grasped, and then reduces the vacuum to a lower level in order to allow the occlusion to be safely cleared. When the occlusion is fully cleared, the vacuum returns to the previous vacuum level. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 5-41 5 • Anterior Segment Surgery Operating Modes Figure 5.34 – CASE OCCLUSION MODE™ Phaco 1. CASE Vacuum 2. Upper Threshold 3. Lower Threshold 4. Vacuum Level crosses Upper Threshold 5. Phaco activated 6. Up Time 7. Vacuum Level 8. Vacuum 9. Time 10. Max Vac You can control and customize the CASE behavior by setting the: 1. Upper and Lower Vacuum Threshold levels 2. CASE Vacuum Level 3. “Up Time” delay, which determines the maximum time that the Upper Threshold Vacuum level is maintained. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 5-42 5 • Anterior Segment Surgery Operating Modes CASE One Touch To simplify the programming of the CASE function, you only need to define the basic CASE parameters once. The CASE function can then be adjusted quickly and simply from the CASE One Touch settings on the surgical screen. Using these controls, the CASE functionality can be changed to provide greater efficiency (Up arrow) or provide more control (Down arrow) to suit any particular combination of cataract density, surgical technique or personal preference. When CASE is On, use the One Touch buttons to adjust the CASE parameters. Figure 5.35 – CASE One Touch Table 5.10 – CASE One Touch Parameter Settings Parameter Pump Ramp Setting CASE -2 Program default CASE -1 Program default CASE STD Program default CASE +1 CASE STD +10% CASE +2 CASE STD +20% CASE Occlusion Delay CASE STD -200 ms CASE STD -100 ms Program default CASE STD +100 ms CASE STD +200 ms CASE Upper Threshold CASE STD -5% Program default Program default Program default CASE STD +5% WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 5-43 5 • Anterior Segment Surgery Operating Modes OCCLUSION MODE™ Phaco Settings You can set different Aspiration Rates for occluded aspiration as opposed to unoccluded aspiration. With the OCCLUSION MODE™ Phaco you can set a different vacuum rise time when the phaco tip is occluded without changing the aspiration rate through an unoccluded needle. To set the Occluded Aspiration Rate thresholds: 1. Press PHACO. 2. Press on the left of the screen. Three new control panels appear for Aspiration and Power. The center panel is for a graphical display of the CASE settings. 3. Press On to set the thresholds. 4. Change the settings in the new control panels as needed. 5. Press Finished to close the window. Figure 5.36 – OCCLUSION MODE™ Phaco 6. Press Finished to close the screen. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 5-44 5 • Anterior Segment Surgery Operating Modes Occlusion Vacuum Threshold In OCCLUSION MODE™ Phaco, you can set an occluded threshold value for vacuum. When in OCCLUSION MODE™ Phaco, there is an additional control panel for Vacuum. The Vacuum Threshold setting lets you choose the vacuum level at which occluded settings take effect. To adjust the Occluded Vacuum Threshold: 1. Press the Up or Down arrows, in Occlusion mode, to increase or decrease the Occluded Vacuum Threshold. 2. When the threshold is decreased, the occlusion settings take effect sooner. Occlusion Aspiration Rate In OCCLUSION MODE™ Phaco, you can set a different Max Flow value for aspiration. There is an additional control panel for aspiration below the standard aspiration control panel. To adjust the occluded aspiration rate: 1. In OCCLUSION MODE™ Phaco, press the Up or Down arrows to increase or decrease the occluded aspiration rate. Figure 5.37 – Occlusion Aspiration Rate Or 2. Press Settings. The Occluded Aspiration Rate pop-up window appears. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 5-45 5 • Anterior Segment Surgery Operating Modes Figure 5.38 – Occluded Aspiration Rate Pop-up Window 3. Press the Up or Down arrows to increase or decrease the occluded aspiration rate. 4. Press Finished to close the window. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 5-46 5 • Anterior Segment Surgery Operating Modes OCCLUSION MODE™ Phaco Power Settings You can set different power levels when the phaco tip is occluded. When you are in OCCLUSION MODE™ Phaco, there is an additional control panel for Power. Figure 5.39 – OCCLUSION MODE™ Phaco Power Settings 1. WHITESTAR® Technology with Pulse Shaping with Ellips™ Technology 2. WHITESTAR® Technology without Pulse Shaping To adjust the occluded power delivery: 1. In OCCLUSION MODE™ Phaco, press the Up or Down arrows to increase or decrease the occluded power level. 2. Press Settings to change other power settings. A Power Settings screen opens. 3. Press Linear or Panel. Depending on whether you select Linear or Panel, there are a total of nine different power settings you can choose. 4. Press the buttons on the right of the Settings screen to select a power delivery value. 5. Press the On button to engage WHITESTAR® Technology. 6. Press Finished to close the screen. Venting an Occlusion When the aspiration port is blocked or occluded by tissue or other material, the vacuum pressure builds up. The aspiration flow system vents to the bottle when the footpedal is released. Another choice is that you can release the footpedal to Position 1 and that causes the aspiration system fluid to vent using pump rotation. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 5-47 5 • Anterior Segment Surgery Operating Modes These methods release the material at the aspiration port and gives you full control if the tip accidentally grabs the capsule or iris. The internal fluidic system allows the desired vacuum level to be maintained when you hold the footpedal at a constant position. The two adjustments associated with aspiration flow are Max Vac and Max Flow. Passive Reflux You can select from either Yes or No. The Yes reverses the pump to vent. The No option opens a path to the bottle pressure and allows reflux into the eye. 1. 2. 3. 4. Ellips™ Technology Select Configuration. Select Surgeons and Programs. Select the applicable operating mode and submode. Press the Passive Reflux button to select either Yes or No. The system default is Yes. Press the Ellips™ Technology button on the Phaco Power Settings screen to activate. The is shown on the Phaco operating mode screen when Ellips™ Technology is on. Ellips™ Technology can be set for each Phaco submode. Note: You must have an Ellips™ Phaco handpiece attached to the system before you can activate the Ellips™ Technology. Figure 5.40 – Phaco with Ellips™ Technology WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 5-48 6 SURGEON PROGRAMS Select Surgeon/Program Add a New Surgeon Edit a Surgeon Select a Preferred Program Create a New Program Edit a Surgeon Program Copy a Surgeon Program Delete a Surgeon Delete a Program Delete a Database Lock a Program Program – Assign Order WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 6-1 6 • Surgeon Programs Select Surgeon/ Program 1. When the System completes the Self Test routine, you are prompted by the System to select a Surgeon (by name). If there are no surgeons defined on the system this screen is not shown. Note: If your name is not listed, you can use Standard Surgeon, the AMO default surgeon setup, and then save those settings to your name. 2. After you select a surgeon, the System prompts you to select a Surgeon Program. If there are no programs defined on the system, the Select A Surgeon Program screen is not shown. Figure 6.1 – Select Surgeon Window WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 6-2 6 • Surgeon Programs Add a New Surgeon To create a new Surgeon program: 1. Press Configuration. 2. Press Surgeons and Programs. Figure 6.2 – Configuration Pop-up Window 3. 4. 5. 6. The Program Settings screen opens. Press Add New Surgeon. The Keyboard window opens. Enter the name of the surgeon. Press Enter to save the new surgeon and exit the Keyboard window. The new Surgeon now appears in the list of available surgeons. Figure 6.3 – Keyboard Screen WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 6-3 6 • Surgeon Programs 7. Edit the settings for this surgeon on the Program Settings screen. Use the Copy Program to copy another surgeon's program. Refer to Copy a Surgeon Program in this chapter. Figure 6.4 – PHACO Submode Settings WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 6-4 6 • Surgeon Programs 8. Press SAVE. If you do not edit any of the settings you can only use Save As. 9. Press Exit Settings. Edit a Surgeon 1. 2. 3. 4. 5. Press Configuration. Press Surgeons and Programs. Press Database. Press Surgeon Database button. Select a surgeon from the list. Figure 6.5 – Select Surgeon 6. 7. 8. 9. Press Edit Surgeon Name. The Keyboard window appears. Edit the name. Press Enter. Press Exit Settings. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 6-5 6 • Surgeon Programs Select a Preferred Program Use the Select Surgeon screen to assign your preferred or default program. the program selected here is indicated with an asterisk (*) on the Select Program to Begin screen when the system is started. When you select Next Case the system asks if you want to return to your preferred program. You are prompted only if you are not in your preferred program. 1. 2. 3. 4. 5. 6. Press Configuration. Press Surgeons and Programs. Press Database. Press Surgeon Database. Select a surgeon from the list. Select Assign Default Program. Figure 6.6 – Select Default Program Pop-up 7. Select a program or select None to clear a selection. 8. Select Finished to close the window. Your preferred program is indicated with an asterisk on the Select Program to Begin screen when the system is started. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 6-6 6 • Surgeon Programs Figure 6.7 – Select a Program to Begin Screen WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 6-7 6 • Surgeon Programs Create a New Program When you create a new surgeon, that surgeon is assigned the AMO Default Program setup. You can customize a program for that surgeon name with your preferred settings. You can also create new programs for existing surgeons. 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. Press Configuration. Press Surgeons and Programs. Press Select Program. Select the surgeon or program from the list. Press Enter. Edit the settings for this program on the Settings window. Use the Copy Program to copy another surgeon's program. Refer to Copy a Surgeon Program in this chapter. Press Save As. The Keyboard window opens. Enter the name of the program. Press Enter. Press Exit Settings. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 6-8 6 • Surgeon Programs Edit a Surgeon Program 1. 2. 3. 4. Press Configuration. Press Surgeons and Programs. Press Select Program. Select the surgeon or program from the list. Figure 6.8 – Select Program 5. 6. 7. 8. 9. Press Enter. Select the mode and submode to edit. Edit the settings for this program on the Settings window. Press SAVE. Press Exit Settings. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 6-9 6 • Surgeon Programs Copy a Surgeon Program You can copy the settings of one surgeon program for use by another surgeon. To copy a surgeon program: 1. Press Configuration. 2. Select Surgeons and Programs. 3. Press Copy Program and select the Surgeon or Program you want to copy from the list. This copies all of the settings of the selected program and the submodes. Note: If Standard Surgeon is the active surgeon, Copy Program is not available to the user. Press Select Program to change the surgeon and program. 4. Press Enter. 5. Press Save As at the bottom of the screen. The Keyboard window opens. 6. Enter the new name for the program. 7. Press Enter to save the new program and exit the Keyboard window. The new program now appears in the list of available programs. 8. Press Exit Settings. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 6-10 6 • Surgeon Programs Delete a Surgeon Use Delete Surgeon to remove a surgeon from the Select Surgeon screen. You cannot delete the current surgeon. Note: You cannot delete a current surgeon or a surgeon that is selected on the Settings screen. 1. 2. 3. 4. 5. 6. Press Configuration. Press Surgeons and Programs. Press Database. Press Surgeon Database. Select a surgeon to delete. Select Delete Surgeon. A delete confirmation pop-up appears. Figure 6.9 – Delete Confirmation Pop-up Window 7. Press Yes. 8. Select Exit Settings. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 6-11 6 • Surgeon Programs Delete a Program Use Delete Program to remove a surgeon program from the Select Program screen. You cannot delete the current program. Note: You cannot delete a current program or a program that is selected on the Settings screen. 1. 2. 3. 4. 5. 6. Press Configuration. Press Surgeons and Programs. Press Database. Press Program Database. Select a program to delete. Select Delete Program. A delete confirmation pop-up appears. Figure 6.10 – Deletion Confirmation 7. Press Yes. 8. Select Exit Settings. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 6-12 6 • Surgeon Programs Delete a Database You can delete a database from your memory device. Contact your AMO Service Representative to delete a database from your system's hard drive. Note: Use only AMO recommended USB stick drives. 1. Insert the USB flash drive into the port on the back of the system. 2. From Configuration, press System Configuration to access the Diagnostic screen. 3. Press Restore All. 4. Press the database to delete from the list. 5. Press Delete Selection. 6. Press OK at the confirmation window. 7. Press Finished to close the window. Figure 6.11 – Database Restore Screen Lock a Program Press the open padlock at any time to lock the program. To edit a locked program, use Save As and rename the program. Note: When a program is locked the program cannot be unlocked. You cannot edit a locked program. Figure 6.12 – Program Lock Button WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 6-13 6 • Surgeon Programs Program – Assign Order Use Program Assign Order to change the order in which the surgeon names are shown on the Select Surgeon window. 1. 2. 3. 4. 5. 6. Press Configuration. Press Surgeons and Programs. Press Database. Select Program Database. A list of programs appears. Select a program. Use the Assign Program Order Up and Down arrows to move the Program. The arrows are found at the bottom of the window. Figure 6.13 – Surgeon and Program Databases 7. Repeat steps 5 and 6 until you are satisfied with the order. 8. Select Exit Settings. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 6-14 7 DIAGNOSTICS Diagnostics Wireless Footpedal Setup Wireless Foot Pedal Calibration Wireless Remote Control Setup Calibrate Touch Screen WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 7-1 7 • Diagnostics Diagnostics To access diagnostics: 1. Press Configuration. Figure 7.1 – Configuration Pop-up Window 2. Press System Configuration. On the System Configuration screen, Diagnostic is selected by default. The Diagnostic screen shows the various Diagnostic Routines, Logs, System Utilities and Database Management functions that can be accessed by the Operator. Press the button for the diagnostic routine you want to run or view. Follow the instructions on the screen to complete the test process. The Service and Factory Diagnostic routines can only be accessed by authorized AMO service personnel. Figure 7.2 – Diagnostics Screen WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 7-2 7 • Diagnostics Wireless Footpedal Setup You can pair the Wireless Foot Pedal (Advanced Control Pedal) to the system with either the Footpedal Cable or wireless. The Wireless Foot Pedal uses Bluetooth® technology to communicate with the system. The Wireless Foot Pedal has a range of ten (10) feet from the system. 1. Press Wireless Setup. 2. Select Footpedal. Figure 7.3 – Wireless Setup Pop-up Screen 3. Select either Wireless Pairing or Wired Pairing. To use Wired Pairing you must have the Footpedal Cable attached to the system. Figure 7.4 – Footpedal Pairing Screen 4. Follow the instructions shown on the screen. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 7-3 7 • Diagnostics Figure 7.5 – Wireless Footpedal Pairing Instructions 5. Press Exit to close the screen and access the Foot Pedal Test screen. • If the blue light is on, the wireless foot pedal is paired. • If the blue light is flashing the wireless foot pedal is not paired. • If the green light is on, the batteries in the foot pedal are charged. • If the green light is blinking, the batteries in the wireless foot pedal need to be charged. Attach the cable to charge the batteries. 6. Use UnPair to unpair either of the Advanced Control Pedals (dual linear) from the system. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 7-4 7 • Diagnostics Wireless Foot Pedal Calibration To maintain optimal use of the foot pedal, the wireless foot pedal must be calibrated from time to time. Figure 7.6 – Footpedal Calibration Screen 1. Press Footpedal Calibration from the Diagnostic screen. The Footpedal Calibration screen can also be accessed from the Foot Pedal Threshold screen. Note: Only press the foot pedal when you are instructed. If you press the foot pedal at any other time the calibration of the foot pedal can fail. 2. Follow the instructions shown on the screen. The Calibration screen closes automatically when completed and the Foot Pedal Test screen opens. 3. Test the foot pedal. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 7-5 7 • Diagnostics Wireless Remote Control Setup Use the Wireless Setup button to connect the System with a Wireless Remote Control. Note: Make sure that the Backlight feature for the Wireless Remote Control is off (before you start the Wireless Setup process). Figure 7.7 – Wireless Setup Screen 1. 2. 3. 4. 5. Press Wireless Setup. Select Remote Control. Press Remote Pair. Follow the messages shown on the screen. For the Remote Control: • Press the corresponding buttons on the wireless remote control as prompted. If Remote Pair fails, follow the instructions on the screen. • Press the buttons on the wireless remote control. • Verify for each button that the corresponding button on the screen lights. If the button does not light on the screen, the test fails. If the test fails contact AMO for technical service. 6. Press Exit to close the window. 7. Press the Unpair button to unpair the Remote. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 7-6 7 • Diagnostics Calibrate Touch Screen The System touch screen needs to be calibrated as part of the system maintenance. Press Calibrate Touch Screen to start the calibration procedure. 1. Press the center of the target circle until the Touch message changes to Release. Figure 7.8 – Touch Screen Target Circle 2. When released, the circle moves to the next point to be calibrated. 3. Repeat Step 1 for all of the calibration points. 4. Press Accept when all of the calibration points are completed. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 7-7 8 CHECK-OUT PRECAUTIONS System Check-out WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 8-1 8 • Check-out Precautions System Check-out The purpose of the check-out procedure is to verify that the System is installed and operating properly. The check-out procedure must be performed at least prior to the first case of the day and any time program changes are made as outlined in the following steps. The IA mode and handpiece are tested first, then the PHACO mode and handpiece, so that the phaco handpiece (which is used first) is set up and ready for surgery. If any of the check-out steps are not successfully performed, they must be repeated. If the instrument still does not work correctly, refer to Chapter 10, “Error Messages Troubleshooting and Diagnostics”. Note: Refer to WARNINGS in Chapter 3, “System Setup” before you set up the System. Set-Up and Prime/Tune Refer to the System Setup and Equipment Operation chapters of this manual for instructions on installing the tubing and priming/tuning the system. Irrigation and Aspiration 1. Connect the tubing to the IA handpiece. 2. Select IA mode. 3. Hold the test chamber near the handpiece tip, press and hold the footpedal in Position 1. 4. Observe the irrigation flow. Phacoemulsification 1. Connect the tubing to the phaco handpiece. 2. Screw the phaco needle onto the handpiece, use your fingers to engage the screw thread, and then use the tip wrench to tighten the needle. Screw the irrigation sleeve assembly over the needle. 3. Select the PHACO mode. 4. Press and hold the footpedal in Position 1. 5. Observe the irrigation flow. 6. Hold the handpiece approximately at the patient’s eye level, and fill the test chamber with irrigation fluid. 7. Place the test chamber over the irrigation sleeve. 8. Occlude the aspiration tubing just below the phaco handpiece. Press and hold the footpedal in Position 2. The actual vacuum level should rise to the preset level. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 8-2 8 • Check-out Precautions 9. Release the occlusion and watch the test chamber to make sure that the test chamber does not collapse. A dent or dimple in the test chamber is normal. 10. To test irrigation, pinch the irrigation tubing at the IA handpiece and watch for the test chamber to collapse. Release the irrigation tubing and the test chamber should fill. 11. Press Next Case to reset the Phaco timer. Phacoemulsification check-out is complete. Diathermy CAUTION: IF A TONE IS NOT HEARD WHEN THE FOOTPEDAL IS PRESSED AND VOLUME ADJUSTMENT IS UNSUCCESSFUL, THE MODE IS NOT FUNCTIONING PROPERLY. REFER TO Chapter 10, “Error Messages Troubleshooting and Diagnostics”. 1. Connect the Diathermy forceps to the cable and the cable to the front panel of the console. 2. Select the Diathermy mode. 3. Press the footpedal. A tone should be heard when the footpedal is pressed. Vitrectomy 1. Attach the irrigation and aspiration cassette pack tubing together. 2. Press Prime on the Prime/Tune screen. 3. Press the VIT button to enter VIT mode. 4. Follow the instructions on the screen. 5. Observe that the: • irrigation fluid flows • aspiration tubing is full and clear of air • the vitrectomy cutter motor is activated (slight sense of motion of the handpiece) • cutter blade operates 6. Press Start Vit Prime. The screen closes automatically when the handpiece is primed. Vitrectomy check-out is complete. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 8-3 9 CARE AND CLEANING Cleaning Procedures Sterilization Procedures WHITESTAR SIGNATURE™ System Cleaning and Care WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 9-1 9 • Care and Cleaning Cleaning Procedures All previously used reusable items must be handled according to ANSI/AAMI ST79:2006 Comprehensive guide to steam sterilization and sterility assurance in health care facilities. Information about the reuse of any products can be found in the Directions for Use for the particular product. All single use items or items which have completed their recommended useful life must be disposed of in accordance with accepted hospital practices and procedures and local governing ordinances and recycling plans. These items can include, but are not limited to, waste materials, waste collection bags, tubing, infusion-sleeves and test chambers. Note: Inspect the Diathermy, Vitrectomy and Phaco handpiece cables for possible damage on a daily basis. Phaco Handpiece The following cleaning procedures for the phaco handpieces must be implemented immediately after use. The straight-through design of the phaco handpiece makes cleaning easy and greatly reduces the likelihood of the handpiece clogging. However, to maximize the life of your instruments, you must clean the instruments immediately after use. Failure to properly clean the instrument can result in tissue buildup and dangerous cross-contamination. WARNING: Balanced salt solutions tarnish and pit metals, which causes the handpiece to deteriorate. Proper cleaning of the instruments prolongs their useful life. AMO recommends using sterile nonpyrogenic water to clean the handpieces and accessories. CAUTION: DO NOT STERILIZE THE HANDPIECES PRIOR TO PERFORMING THE CLEANING PROCEDURES DESCRIBED BELOW. The following cleaning procedure is to be performed at the end of each surgical case: 1. With the tip cap sleeve and phaco tip still in place on the handpiece, inject 60 cc of sterile nonpyrogenic water through the irrigation tubing of the handpiece with a syringe. Remove the syringe and fill the syringe with air. Attach the syringe and flush the tube and handpiece with air. 2. Inject 60 cc of sterile nonpyrogenic water through the aspiration tubing of the phaco handpiece. It is helpful to use a female to female connector to attach the syringe to the aspiration tubing. Remove the syringe and fill the syringe with air. Attach the syringe and flush the tube and handpiece with air. 3. Carefully remove the phaco tip cap sleeve and phaco tip from the handpiece for disposal or to be sanitized and stored 4. Inject sterile nonpyrogenic water into the test chamber with a syringe and then empty. Repeat this step three to four times. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 9-2 9 • Care and Cleaning 5. Aspirate sterile nonpyrogenic water through the phaco tip into a syringe; this clears any debris from within the tip and prevents clogging of the suction port. 6. Gently wipe the power cable of the handpiece with gauze soaked in distilled water. WARNING: Improper/inadequate cleaning may result in particulate matter adhering to the instrument and exfoliation of particles into the surgical field. In addition, the function and life expectancy of the phaco handpiece can become compromised. CAUTION: DO NOT CLEAN THE PHACO HANDPIECE WITH ANY TYPE OF ULTRASONIC CLEANING DEVICE; THE CLEANING DEVICE CAN DAMAGE THE PIEZOELECTRIC CRYSTALS. Irrigation/Aspiration Handpiece 1. Back-flush the IA handpieces immediately at the end of the procedure. Use a 10cc syringe with sterile nonpyrogenic water and flush the water from the back of the handpiece through the tip. This process must be performed at least two times through both the irrigation and aspiration channels. Note: You can use other available AMO® products designed for this process (IA Cleaning Kit, AMO Part No. OM05510114). Figure 9.1 – I/A Handpiece Cleaning 2. Make sure IA handpieces are dry when they are stored. Diathermy Handpiece Clean the diathermy handpieces with the same procedures you use to clean other ophthalmic instruments. Note: Inspect the Diathermy, Vitrectomy and Phaco handpiece cables for possible damage on a daily basis. Vitrectomy Cutter The vitrectomy cutter is a disposable, single-use instrument. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 9-3 9 • Care and Cleaning Sterilization Procedures AMO recommends that you follow the sterilization procedures outlined in this section to maximize the life of your System instruments. All parts must be cleaned thoroughly prior to sterilization, and all sterilization equipment must be validated prior to use. CAUTION: DO NOT STERILIZE THE HANDPIECES PRIOR TO PERFORMING THE CLEANING PROCEDURES DESCRIBED EARLIER IN THIS SECTION. THE STORAGE CASES PROVIDED CANNOT BE PLACED IN AN AUTOCLAVE. The following sterilization techniques, times, and temperatures must be used in order to ensure consistent product performance: Gravity Displacement Sterilization – A type of sterilizer in which incoming steam displaces the residual air through a port or drain usually in or near the bottom of the sterilizer chamber. Typical operating temperatures are 121 to 123°C (250 to 254°F) and 132 to 135°C (270 to 275°F). Prevacuum Sterilization – A type of sterilizer which relies on one or more pressure and vacuum excursions at the beginning or end of the cycle. This method of operation usually results in shorter cycle times because of the rapid removal of air from the chamber and the load by the vacuum system, the usually higher operating temperature (132 to 135°C / 270 to 275°F; 141 to 144°C / 285 to 290°F), and the shorter exposure time for porous loads. Note: The cycle times require the product to be wrapped. In an emergency situation only Flash Sterilization in accordance with ANSI/AAMI ST79:2006 Comprehensive guide to steam sterilization and sterility assurance in health care facilities can be used. The parameters for mixed porous and nonporous items must be used. CAUTION: GAS STERILIZATION IS NOT RECOMMENDED. Cooling is not necessary prior to reassembly; however, caution must be used to prevent burns. Follow the handpiece assembly instructions. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 9-4 9 • Care and Cleaning WARNING: Sterility assurance is the responsibility of the user. All nonsterile accessories must be sterilized prior to use. In addition, AMO recommends a terminal sterilization cycle in the autoclave after the final case of the day. This cycle must include a drying cycle to remove moisture from the tubing and handpieces for storage. Devices undergoing sterilization must be thoroughly cleaned to minimize bio-burden. Validation of the sterilization vessel and the sterilization cycle is the responsibility of the user. 1. After sterilization, store the instruments in a safe, clean environment. Keep the instruments dry and free of dust. Make sure that the handpiece nose cone tips are adequately protected during storage. 2. Do not wind the phaco handpiece cord too tight. Handle the cord as you would a fiber optic cable. Follow the natural curve of the cord and wind only as tight as the natural curve of the cord (approximately 6 inch coiled cord diameter). WARNING: Handle the phaco handpiece with extreme care. The piezoelectric crystal in the handpiece is very sensitive to shock. If the handpiece is dropped, it is possible that the handpiece might not function correctly. If this happens, contact AMO for repair information or replacement. WHITESTAR SIGNATURE™ System Cleaning and Care 1. Turn the power switch on the back of the System Off before you unplug the system from the wall outlet. 2. At the end of the day, thoroughly wipe down the system, cart, power pole and footpedal using a cloth dampened with a germicidal detergent and sterile nonpyrogenic water. Be careful not to saturate any part of the system or the footpedal with liquid. Excessive liquid can damage the System electronics. 3. Do not push or pull on the system components. 4. AMO recommends that you leave the footpedal and power cords connected to the system to prevent loss and unnecessary wear on the electrical connectors. 5. Although the footpedal is water-resistant, make sure that the footpedal is kept as dry as possible. 6. Place the Advanced Control Pedal (dual linear) in the storage recess at the bottom of the console so that the footpedal batteries can charge. You can attach the footpedal cable to the console to charge the batteries. 7. Place the wireless remote control in the storage recess on the top of the console so that the Wireless Remote Control batteries can charge. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 9-5 10 ERROR MESSAGES TROUBLESHOOTING AND DIAGNOSTICS Error Message Display Fuse Replacement Procedure Wireless Foot Pedal Battery Replacement Procedure Most Common User-Correctable Problems Status, Warning and Error Messages System Operation (Error) Messages Troubleshooting WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 10-1 10 • Error Messages Troubleshooting and Diagnostics Error Message Display The red Error Messages are shown at the top of the screen. Press the Help button to open the corrective action for that error. When the error is corrected, press OK to clear the error message from the screen. If the error message is cleared but not corrected, the error message is generated again. The yellow Alerts are shown at the top of the screen. The alert does not need to be cleared as an error message. An alert, for example, can be: Remote Control Battery power level is 10 – 25% of maximum. The battery needs to be charged. WARNING: DO NOT try to replace the Wireless Remote Control batteries. Call your AMO Technical Service representative to replace the batteries. Fuse Replacement Procedure If the System does not turn on when the power switch is turned On, and you have confirmed that the power cord is properly connected and plugged in, check to see if the fuse is bad. Note: To prevent the risk of fire or damage to the instrument, replace the fuses with the exact type and rating as indicated below (check the voltage sticker on the back panel of System to confirm your system voltage): Table 10.1 – Fuse Specifications Voltage Console 100/120/240 Quantity Fuse Specifications 6.3A, 250V, Bussman GDA To replace the console fuses: 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. Unplug the System electrical power. Unplug the power cord from the back panel. Locate the fuse holder on the back panel of the System, as shown below. Use a small screwdriver to gently pry open the cover and expose the fuse holder. Gently pry out the fuse holder. Remove the bad fuse and replace the fuse with a new fuse (value and size specified above). Replace the fuse holder. Make sure that the arrows point to the right side of the back panel. Tilt the fuse holder slightly to the right and push in. Push the fuse holder cover up and in until the cover snaps closed. Reconnect the power cord to the back panel. Plug the System into an electrical receptacle (outlet). WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 10-2 10 • Error Messages Troubleshooting and Diagnostics Figure 10.1 – Fuse Location 1. Power Switch Wireless Foot Pedal Battery Replacement Procedure 2. Fuse Holder Four AA size NiMH batteries provide power to the wireless foot pedal. You must replace the batteries with the same size and type (NiMH) of batteries. If incorrect batteries are used, the wrong batteries might cause damage to the foot pedal. To replace the batteries in the foot pedal: 1. Remove the screws on the battery cover. The battery cover is located on the bottom of the foot pedal. 2. Remove the old batteries. Do not throw the batteries in to the garbage. Use the proper disposal method for the batteries. 3. Insert the new batteries. Make sure that the batteries are inserted correctly. 4. Replace the battery cover and tighten all of the screws. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 10-3 10 • Error Messages Troubleshooting and Diagnostics Figure 10.2 – Battery Location for the Wireless Foot Pedal 1. Battery Cover Screws (7) WHITESTAR SIGNATURE™ System 2. NiMH Batteries Rx Only – Z370147 Rev. C 1108 10-4 10 • Error Messages Troubleshooting and Diagnostics Most Common User-Correctable Problems Use the information in this section if you are not successful with the System Check-out. Consult this section to resolve the problem before you call AMO for technical service. Before you call AMO for service: • Make sure that the System is plugged in to a power recptacle. • Make sure that there is electrical power to the receptacle. • If there is no phacoemulsification, make sure that the phaco needle is tight on the handpiece. • If there is no phacoemulsification, make sure that the phaco needle is compatible with the handpiece (for example, non-AMO® phaco needle on an AMO® handpiece). • If there is no phacoemulsification, confirm that phaco needle/handpiece was not damaged by dropping or misuse. • If no irrigation occurs, shake the drip chamber to confirm that the ball or valve moves freely. If there is no rattle sound, replace the drip chamber with another disposable tubing pack. Status, Warning and Error Messages The System shows Status, Warning and Error Messages on the monitor. The message can show possible solutions or recommendations to clear the error. The messages can indicate the available options if a component or subsystem fails. The messages are listed in the following pages with the corrective actions to be taken to clear the error. Recycle Power as a Corrective Action means that you turn the System Off (through the normal shut down procedure), wait a few seconds, and then turn the System On. If an error cannot be corrected, document the error message before you call AMO for technical service. Technical Service needs to know the error message to diagnose and correct the error. System Operation (Error) Messages Error Number 14 Table 10.2 – Fluidic Controller Error Messages Message Probable Cause Corrective Action Vacuum Parameter Check Failure. Hardware failure or program error. Select Next Case. 15 Flow Parameter Error Hardware failure or program error. Select Next Case. 16 FP Yaw Parameter Error Hardware failure or program error. Select Next Case. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 10-5 10 • Error Messages Troubleshooting and Diagnostics Error Number 17 Message FP Pitch Parameter Error Hardware failure or program error. Select Next Case. 18 IV Check Error Hardware failure or program error. Select Next Case. 19 Vit Cutter Check Error Hardware failure or program error. Select Next Case. 101 Fluidics communication error. Invalid data from the IH or communication errors. Select Next Case. 102 Fluidics write error. Microcontroller SPI, SPI Bus, EEPROM, or ADC is faulty. Cycle power. 103 Fluidics read error. Microcontroller SPI, SPI Bus, EEPROM, or ADC is faulty. Cycle power. 104 Fluidics Reservoir Vacuum Level Error. External air pressure low. Venturi muffler clogged. External air valve clogged. External air leak. Venturi vacuum path leak. Vacuum sensor not calibrated or faulty. Reprime the System. 105 Fluidics Reservoir Leak. Venturi vacuum path leak Reprime the System. 106 Fluidics Tank Vacuum Level Error. Reservoir vacuum is low. Tank vacuum path leak. Vacuum sensor not calibrated or faulty. Vacuum regulator not calibrated or faulty. Vacuum regulator drive circuit failure. Reprime the System. 107 Fluidics Tank Leak. Tank vacuum path leak. Reprime the System. WHITESTAR SIGNATURE™ System Probable Cause Rx Only – Z370147 Rev. C 1108 Corrective Action 10-6 10 • Error Messages Troubleshooting and Diagnostics Error Number 108 Message Probable Cause Corrective Action Fluidics Pack Vacuum Level Error. Reservoir vacuum is low. Pack vacuum path leak. Vacuum sensor not calibrated or faulty. Vacuum regulator not calibrated or faulty. Vacuum regulator drive circuit failure. Reprime the System. 109 Fluidics Pack Leak. Pack leak. Reprime the System. 110 Fluidics RAM error. Bad Microcontroller. Cycle power. 111 Fluidics ROM error. Bad Microcontroller. Cycle power. 112 Fluidics Master Communication error. Instrument Host malfunction. Bad microcontroller. Cycle power. 113 Drain Pump Fault. Droplets, bubbles, or fog on chamber walls. Bad fluid level sensor(s). Bad cable. Fluid level sensor drive circuits faulty. Drain pump drive circuit fault. Check the chamber and the bag for over-inflation. Select Next Case. 114 Fluidics DAC Fault. Circuit failure (I2C bus, DAC, or micro). Reprime the System. 115 Fluidics Evacuation Vacuum Level Error. Reservoir vacuum is low Evacuation vacuum path leak Vacuum sensor not calibrated or faulty Vacuum regulator not calibrated or faulty Vacuum regulator drive circuit failure Reprime the System. 116 Fluidics Evacuation Leak. Evacuation path leak. Reprime the System. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 10-7 10 • Error Messages Troubleshooting and Diagnostics Error Number 117 Message Probable Cause Fluidics Fluid Level Sense Error. Droplets, bubbles, or fog on chamber walls. Bad fluid level sensor(s). Bad cable. Fluid level sensor drive circuits faulty. Check the chamber and the bag for over-inflation. Select Next Case. 118 Fluidics Irrigation Valve error. Valve failure. Drive circuit failure. Cycle power. 119 Fluidics Pinch Valve error. Valve failure. Drive circuit failure. Cycle power. 120 Fluidics Silicone Extraction Valve Fault Valve failure. Drive Circuit failure. Disable Venturi or select Next Case. 121 Fluidics Pack Alignment Valve Fault. Pump failure. Drive circuit failure. Reinsert the pack and reprime. 122 Fluidics Dump Valve Fault. Valve failure. Drive circuit failure. Disable Venturi or select Next Case. 123 Fluidics Venturi Valve Fault. Valve failure. Drive circuit failure. Disconnect compressed air. Reprime the system. 124 Fluidics Rotary Vane Fault. Pump failure. Drive circuit failure. Connect compressed air. Reprime the system. 125 Fluidics Pack Valve error. Valve failure. Drive circuit failure. Cycle power. 127 Fluidics Valve Vent error. Irrigation blocked. 128 Fluidics Pack Loading error. Pack not properly seated. 129 Fluidics Proportional Valve Fault. Valve failure. Drive circuit failure. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 Corrective Action 1. 2. 3. 4. End the current Case. Start a New Case. Reprime the System. Turn the system off, wait a few seconds, then turn the system on. 5. Install a new tubing cassette 6. If the error does not clear or if the error continues to occur, document the Error Message and contact AMO for technical service. Reload the tubing cassette. Reprime. Disconnect compressed air. Reprime the system. 10-8 10 • Error Messages Troubleshooting and Diagnostics Error Number 130 Message Fluidics Encoder error. Pack loading problem. Encoder is faulty. Decoder circuit is faulty. Stepper driver circuit is faulty. Reload the tubing cassette. Select Next Case. 131 Fluidics Mode error. Instrument Host malfunction. Bad SSC Board. Bad footpedal. Cycle power. 132 Fluidics VAC regulator current is too high or too low. Vacuum regulator faulty. Drive circuit faulty. Disable Venturi or select Next Case. 133 Fluidics strain gauge ADC error. ADC is faulty. Cycle power. 134 Fluidics Drain Pump Rotational Error. Pack loading problem. Encoder is faulty. Decoder circuit is faulty. Stepper driver circuit is faulty. Insert Fusion™ Pack or select Next Case. Reprime the system. 135 Low external air pressure. Leak in external air supply path. Pressure regulator set too low. Pressure sensor faulty. Reinsert the pack and reprime. Check the external air supply. 136 Fluidics VAC Regulator Vent Fault. Pinch valve is blocked. Disable Venturi or select Next Case. 137 Footpedal error. Bad footpedal or user depressing footpedal. Release the footpedal. Disconnect and reconnect footpedal. Cycle power and retry. 138 Tank fluid level has reached the top sensor. Drain pump cannot keep up with the input of fluid. Please wait for the tank to drain 144 Fluidics Vacuum Senors Disagree Error. Leak in vacuum path Vacuum sensor faulty. Reinsert the pack and reprime. 147 Reservoir vacuum is too low. Target vacuum cannot be reached. Leak Vacuum regulator faulty Drive circuit faulty Select Next Case. Reprime the system. WHITESTAR SIGNATURE™ System Probable Cause Rx Only – Z370147 Rev. C 1108 Corrective Action 10-9 10 • Error Messages Troubleshooting and Diagnostics Error Number 148 Message Probable Cause Corrective Action Pressure to pack capture mechanism is less than 60 psi. Leak Reinsert the pack and reprime. 149 Unloaded strain gauge reading is too high or too low. Pack not loaded correctly. Reinsert the pack and reprime. 201 Phaco Communication error. Bad data sent from host. Retune or cycle power. 202 Phaco power error. Hardware failure (phaco driver). Retune or cycle power. 203 Phaco handpiece error. Bad handpiece. Retune or cycle power. Replace the phaco handpiece. 204 Phaco handpiece error. Wire in handpiece broken. Retune or cycle power. Replace the phaco handpiece. 207 Incompatible Handpiece Error. Incompatible handpiece. 1. Turn off Ellips™ Technology. 2. Attach the Ellips™ handpiece. 3. Tune the handpiece. 210 Phaco RAM error. Chip is bad. Cycle power. 211 Phaco ROM error. Bad 196 processor. Cycle power. 212 Phaco controller timeout. Host stopped writing to the Phaco controller. Cycle power. 281 Phaco communication error. Software bug or Hardware failure. Cycle power. 282 Phaco error. Bad handpiece. Check handpiece and retune. 283 Phaco error. Driver failure. Check handpiece and retune. Replace the handpiece and tune. 284 Phaco power supply error. Bad Power Supply. Cycle power or call service. 285 Check for loose handpiece and retune. Tip is loose. Check for loose handpiece tip and retune. Replace the handpiece and tune. 286 Phaco handpiece impedance error. Bad handpiece. Check handpiece and retune. Replace the handpiece and tune. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 10-10 10 • Error Messages Troubleshooting and Diagnostics Error Number 288 Message Diathermy error. DIA subsystem issue. Check handpiece. Select Next Case or cycle power. 290 Footpedal error. Bad footpedal or user pressing the footswitch. Check footpedal. Cycle power. 291 Phaco Diathermy power supply error. Software or hardware failure. Cycle power. 301 Pneumatics RAM error. Microcontroller failure. Cycle power. 302 Pneumatics ROM error. Microcontroller failure. Cycle power. 303 Pneumatics Master communication error. Watchdog event. PC104 Bus failure. Micro failure. CPLD failure. Cycle power. 307 Pneumatics communication error. Invalid data received by the IH or communication error. Cycle power. 308 External air pressure high/ low. Valve failure. Drive circuit failure. Check compressed air supply. Select Next Case. 309 Piston pump pressure high/ low. Pump failure. Drive circuit failure. Select Next Case. 310 Vit selector valve pressure high/low. VIT Selector Valve failure. Drive circuit failure. Select Next Case. 311 Dump valve pressure high/ low. VIT Dump Valve failure. Drive circuit failure. Select Next Case. 312 Cut valve pressure high/ low. VIT Cut Valve failure. Drive circuit failure. Select Next Case. 322 Pneumatics system pressure too low. V1 External Air valve not open. Piston Pump not working. System leak. Dump valve not closing. Vitrectomy Cut valve always on. Select Next Case. WHITESTAR SIGNATURE™ System Probable Cause Rx Only – Z370147 Rev. C 1108 Corrective Action 10-11 10 • Error Messages Troubleshooting and Diagnostics Error Number 323 Message Probable Cause Pneumatics system pressure too low. PP1 Piston Pump not working. Piston Pump not working. System leak. Dump valve not closing. Vitrectomy Cut valve always on. Select Next Case. 327 Pneumatics system pressure too low at the high cut rates. PP1 Piston Pump not working. Piston Pump not working. System leak. Dump valve not closing. Vitrectomy Cut valve always on. Selector valve is not changing. Select Next Case. 336 Pneumatics system pressure too low at the low cut rates. PP1 Piston Pump not working. Piston Pump not working. System leak. Dump valve not closing. Vitrectomy Cut valve always on. Selector valve is not changing. Select Next Case. 353 IH to GUI Communication Timed Out. Software error or hardware error. Select Next Case. 360 IH Fluidics – read error. Communication error. Cycle power. 361 IH Fluidics – write error. Communication error. Cycle power. 362 IH Fluidics – Comm. error. Communication error. Cycle power. 370 IH Phaco read error. Communication error. Cycle power. 371 IH Phaco write error. Communication error. Cycle power. 372 Bad Phaco long pulse. Communication error. Check program setting. Cycle power. 373 IH Invalid Phaco burst setting. Communication error. Check program. Cycle power. 374 Handpiece removed during Phaco. No handpiece is connected. 1. Attach a handpiece. 2. Tune the handpiece. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 Corrective Action 10-12 10 • Error Messages Troubleshooting and Diagnostics Error Number 375 Message Incompatible HP. Attempted to use Ellips™ Phaco settings with a WHITESTAR® handpiece. 1. Turn off Ellips™ Technology. 2. Attach the Ellips™ handpiece. 3. Tune the handpiece. 380 IH Pneumatics – read error. Communication error. Cycle power. 381 IH Pneumatics – write error. Communication error. Cycle power. 390 IH Diag read error. Communication error. Cycle power. 391 IH Diag write error. Communication error. Cycle power. 416 Footpedal communication error. Could not open port. Footpedal not responding. Reconnect footpedal. 418 Footpedal compatibility error. New footpedal firmware. Replace footpedal. 501 Prime excessive vacuum error. Communication error. Check the tubing cassette. Reload or replace the tubing cassette. Reprime. 502 Prime low bottle height error. Bottle not at the proper height. Increase bottle height and reprime. 503 Prime low vacuum error. Hardware failure. Check the tubing cassette. Reload or replace the tubing cassette. Reprime. 507 Prime EQ pressure error. Hardware failure. Reprime. 508 Prime low venturi vacuum error. Hardware failure. Reprime. 511 IV Pole communications error. Communication error. Reprime the system. 512 IV Pole communications error. Communication error. Reprime the system. 513 IV Pole communications error. Communication error. Reprime the system. 514 IV Pole error. Communication error. Reprime the system. WHITESTAR SIGNATURE™ System Probable Cause Rx Only – Z370147 Rev. C 1108 Corrective Action 10-13 10 • Error Messages Troubleshooting and Diagnostics Error Number 515 Message Probable Cause Corrective Action IV Pole calibration error. Communication error. Reprime the system. 516 IV Pole communication error. Communication error. Reprime the system. 517 IV Pole jammed. Jammed. Motor failure. A “Short” in the motor wires. Obstruction is not allowing the pole to move Check for obstructions. Reprime the system. 601 Tune excessive vacuum error. Hardware failure. Check the tubing and the connections to the handpiece. Retune. 605 Tune no handpiece error. Hardware failure. Insert handpiece and retune. 2000 DLL CRC Error DLL checksum does not match config.dat. Cycle power. 2001 CRC Error STR checksum does not match config.dat. Cycle power. 2002 Database Self Test Error Database file checksum does not match config.dat. Cycle power. 2003 Error updating database file. Error when database was saved. Cycle power. 2004 Error adding language. Error during the Install Language session. Cycle power. 2005 Error reading USB memory stick. Error during an Import or Export session. Cycle power. 2006 Error loading DLL. Cannot find or load a DLL file. Cycle power. 2007 Record file save error. Error when Record database file was saved. Cycle power. 2008 Error reading Record file. Cannot read Record database file. Cycle power. 2010 IH Communication timed out. No communication with the IH. Cycle power. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 10-14 10 • Error Messages Troubleshooting and Diagnostics Error Number 2011 Message Probable Cause Corrective Action Error retrieving version strings from IH. Cannot not retrieve the IH version numbers. Cycle power. 2012 IH timeout error. No communication with IH. Cycle power. 2014 IH Selftest error. Cannot get Selftest status from the IH. Cycle power. Troubleshooting Table 10.3 – Troubleshooting – General General Problem Corrective Action The System does not come on when the power switch is turned on. 1. Turn the power switch Off. 2. Confirm that the power cord is connected to the console back panel. 3. Confirm that the power cord is plugged into the electrical receptacle or another power source. 4. Confirm that there is electrical power to the wall receptacle or power source. 5. Turn the system On. 6. If the system still does not come on, turn the power Off. Check for bad fuses and replace the fuse if necessary. 7. Contact AMO for Technical Service. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 10-15 10 • Error Messages Troubleshooting and Diagnostics General Problem Corrective Action The wireless remote control does not pair. 1. Make sure that you are pairing only one remote. If you try to pair more than one remote at the same time, the pairing fails. 2. Only pair the remote with one console at a time. Do not press the pairing key sequence on multiple remote controls as this causes the pairing to fail. 3. Do not have any other Bluetooth® devices in the same area as the remote and the console (other remote controls, dual linear foot pedals, cell phones, or headsets, for example) as the pairing operation will fail. The software only detects a maximum of nine (9) devices any more than nine and the pairing fails. 4. Check to see if the remote control is in “Sleep” mode. If the remote is in “Sleep” mode, press the Backlight button on the remote. Complete the UP, DOWN, RIGHT, LEFT, RELOAD key sequence to pair the remote. Note: Always press the Backlight button before you pair the remote. 5. The remote control can only be paired with one console at a time. Make sure that the remote has not been paired with another console. You must: • Unpair the remote from the console. • Shut down the console. • Pair the remote with the new console. Make sure this console is at least 40 meters away from the first console. 6. The remote cannot be paired with another console after that remote has been paired. (You cannot pair one remote with two (2) consoles.) • Unpair the remote from the console. • Move the first remote out of range from the console. • Wait for the first remote to go into “Sleep” mode. • Pair the new remote. 7. Make sure that the batteries are fully charged before you pair the remote with the console. Low batteries can cause pairing failures. 8. Charge the batteries if pairing has failed after several attempts. 9. When the batteries are charging (the remote is in the charge cradle): • The Bluetooth® is turned off • The remote cannot be used • Pairing cannot be performed WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 10-16 10 • Error Messages Troubleshooting and Diagnostics General Problem Dual Linear Foot Pedal does not pair.(Advanced Control Pedal) Corrective Action 1. Make sure that the foot pedal is not paired with another console. 2. Do not have any other Bluetooth® devices in the same area as the foot pedal and the console (other remote controls, dual linear foot pedals, cell phones, or headsets, for example) as the pairing operation will fail. The software only detects a maximum of nine (9) devices any more than nine and the pairing fails. 3. Make sure that the batteries are fully charged before you pair the foot pedal with the console. Low batteries can cause pairing failures. 4. Charge the batteries if pairing has failed after several attempts. 5. When the batteries are charging (the foot pedal is in the charge cradle): • The Bluetooth® is turned off • The foot pedal cannot be used • Pairing cannot be performed The footpedal is not operating properly. 1. Go to the Diagnostics section and perform a Footpedal Test. 2. Confirm the footpedal cord is connected at the back of the console. 3. Confirm the footpedal is paired to the System, for the Advanced Control Pedal (dual linear) only. 4. Perform a Foot Pedal Calibration, for the Advanced Control Pedal (dual linear) only. 5. Replace the wireless footpedal batteries, Advanced Control Pedal (dual linear) only. The Programmable IV Pole does not respond. 1. The pole might have reached maximum or minimum height. 2. Attempt a Programmable IV Pole height adjustment with the touch screen, remote, or the up and down switch on the side of the system. The Touch Screen does not respond. Perform the Touch Screen Calibration procedure as described in Diagnostics. Priming Errors. 1. 2. 3. 4. 5. 6. WHITESTAR SIGNATURE™ System Check the tubing pack loading, including reloading the tubing cassette. Verify that there are no kinks, clogs, or loose fittings. Replace the handpiece and the tip and prime. Replace the tubing cassette. Check the test chamber for proper installation and leaks. Contact AMO Technical Service to check the vacuum. Rx Only – Z370147 Rev. C 1108 10-17 10 • Error Messages Troubleshooting and Diagnostics Table 10.4 – Troubleshooting – Irrigation Irrigation Problem Corrective Action No irrigation flow. 1. Make sure the appropriate mode is selected on the screen. 2. Check for kinks in the irrigation tubing. 3. Check the tubing connection to the handpiece. 4. Tap the drip chamber to make sure the valve operates properly. 5. Check the bottle height. 6. Press the footpedal to Position 1 and check for flow. 7. Listen for the irrigation pinch valve in the tubing manifold area to confirm that the valve operates when the footpedal is pressed. 8. If there is still no flow, replace the tubing cassette. Reduced/insufficient irrigation flow. 1. 2. 3. 4. Irrigation flow continues even when footpedal is Off (Position 0). 1. Check that the footpedal is not obstructed and not stuck in P 1. 2. Check the footpedal operation. 3. Verify that Continuous Irrigation is not active. Anterior chamber is too shallow or too deep. 1. 2. 3. 4. 5. Using large amounts of fluid. 1. Check the bottle height. 2. Check the incision size. 3. Check the flow rate (pump speed too high). 4. Check that no fluid enters the collection bag when you do not use irrigation. 5. Reseat or replace the tubing. WHITESTAR SIGNATURE™ System Check for kinks in the tubing or leaks in the tubing or the handpiece. Check the bottle height. Check the tubing connections. Check for a pinched irrigation sleeve at the incision. Check the bottle height. Too shallow, check for a pinched irrigation sleeve at the incision. Check the pump speed (flow rate). Check that the irrigation tubing is not obstructed. Make sure Irrigation and Aspiration are balanced. Rx Only – Z370147 Rev. C 1108 10-18 10 • Error Messages Troubleshooting and Diagnostics Table 10.5 – Troubleshooting – Aspiration Aspiration Problem Corrective Action No aspiration. 1. 2. 3. 4. 5. Poor aspiration. 1. Check the flow rate. 2. Check the footpedal operation. 3. Check for kinks or clogs in the tubing. 4. Make sure that the handpiece is not clogged. 5. Check the tubing connection to the handpiece. 6. Check the IA handpiece o-rings for excessive wear. Replace the o-rings, if needed. Not building vacuum. Pump does not turn. 1. Check the programming. If the surgeon is in “linear vacuum” as opposed to “linear aspiration”, the footpedal must be pressed through Position 2 for the vacuum to reach the preset maximum. 2. Make sure the footpedal is pressed. 3. Check the tubing connection to the handpiece. 4. Check for air in the irrigation and aspiration tubing. 5. Check the system vacuum settings. 6. Replace the tubing cassette 7. Run IA Prime. 8. Check the flow rate. Chamber shallowing or partially collapses. 1. Check the bottle height and the handpieces for correct position. 2. Check the flow rate setting. 3. Check the tubing fittings to the handpiece. 4. Check for kinks in the tubing. 5. Remove the handpiece and perform the test chamber test to make sure the handpiece is balanced. 6. Make sure Irrigation and Aspiration are balanced. WHITESTAR SIGNATURE™ System Make sure the appropriate mode is selected on the screen. Check for kinks or clogs in the tubing. Check the tubing connection to the handpiece. Make sure that the handpiece is not clogged. Press the footpedal to Position 2 and check the pump function. Rx Only – Z370147 Rev. C 1108 10-19 10 • Error Messages Troubleshooting and Diagnostics Table 10.6 – Troubleshooting – Phacoemulsification Phacoemulsification Problem Corrective Action No phacoemulsification. 1. Make sure that the PHACO mode is selected on the touch screen. 2. Make sure that the System is Primed and Tuned. 3. Check the footpedal operation. 4. Make sure that the phaco handpiece cord is properly connected to the phaco receptacle on the front of the system. 5. Check the Phaco Power setting. 6. Make sure that the phaco tip is tight on the handpiece. 7. Check to make sure that the phaco tip is not damaged. 8. If the tip is damaged, replace the tip with a new tip and retune. Poor or intermittent phacoemulsification. 1. Check all of the corrective steps above for “No Phacoemulsification”. 2. Remove the phaco tip and then replace the tip. Make sure the tip is tight on the handpiece. 3. Check the Phaco Power delivery setting for both unoccluded and occluded (if applicable) settings. 4. Tune the phaco handpiece. Table 10.7 – Troubleshooting – Diathermy Diathermy Problem Corrective Action No diathermy or poor diathermy. 1. Make sure that the Diathermy mode is selected on the touch screen. 2. Check the footpedal operation. 3. Check the Diathermy Power setting. 4. Check the diathermy cord for a secure connection to the forceps and to the diathermy receptacles on the system. 5. Make sure that the diathermy cord connections are dry. 6. Try to use diathermy starting at a low power setting and gradually increase the power. 7. Replace the diathermy cord. 8. Replace the diathermy handpiece. No sound when using diathermy. 1. Make sure the Volume Setting is set at 6 or greater in Settings. 2. Check for sounds when you push any touch screen or remote buttons. 3. Check for an audible confirmation upon completion of system start-up test (at power up). 4. Perform the Sound Test on the Diagnostics screen. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 10-20 10 • Error Messages Troubleshooting and Diagnostics Table 10.8 – Troubleshooting – Vitrectomy Vitrectomy Problem No vitrectomy cutting or poor cutting. WHITESTAR SIGNATURE™ System Corrective Action 1. Make sure that the Vitrectomy mode is selected on the touch screen. 2. Verify that the surgeon is in footpedal Position 3, if IAC step vitrectomy is programmed. If ICA is programmed, verify the footpedal is in Position 2. 3. Check the footpedal operation. 4. Check the tubing connections to the vitrectomy cutter. 5. Check the vitrectomy tubing connection to the front panel receptacle on the system. 6. Check the Vitrectomy Rate (CPM) setting on the touch screen. Lower the CPM, if necessary. 7. Check that irrigation and aspiration are working correctly. 8. Verify that the cutter blade moves. 9. Replace the vitrectomy cutter and try again. Rx Only – Z370147 Rev. C 1108 10-21 11 WARRANTY AND MAINTENANCE Warranty Statement WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 11-1 11 • Warranty and Maintenance Warranty Statement AMO warrants for a period of two years (24 months) from the date of installation of the WHITESTAR SIGNATURE™ System console, footpedal, wireless remote control, programmable power pole and the phaco handpiece to be free from defects in materials and workmanship when properly installed, maintained, and used for the intended purpose. MISUSE AND MISHANDLING ARE NOT COVERED UNDER WARRANTY. AMO’s sole obligation is to repair or replace, at AMO’s option, the defective part(s). The Irrigation/Aspiration Handpiece Set, Diathermy Forceps and Diathermy Cord are warranted for ninety (90) days. This warranty applies only to the original purchaser/user of the device and only so long as the equipment is used in the country to which it was originally shipped by AMO. THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING WITHOUT LIMITATION THE WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. IN NO EVENT SHALL AMO BE LIABLE TO THE PURCHASER FOR CONSEQUENTIAL DAMAGES. Extended Warranty Extended Warranty Contracts (excluding the phaco handpiece) are available. Contact AMO for information on the availability of an Extended Warranty Contract. Note: If outside the United States, contact your local AMO office or representative for warranty information. Maintenance User maintenance of the WHITESTAR SIGNATURE™ System is limited to those adjustments and corrective actions given in the Error Messages and Troubleshooting, and Diagnostics sections of this manual. There are no user serviceable components within the machine and you must not attempt to access the internal components. Any attempt to do so will void the warranty. Routine or periodic maintenance of the WHITESTAR SIGNATURE™ System by an AMO representative is recommended at least annually. AMO recommends the measurement of PE resistance and leakage current according to IEC 601-1 every two years. If a problem continues following setup, check-out and troubleshooting as per the procedures given in this manual, contact AMO for corrective action (1-877-AMO4LIFE in USA 1-877-266-4543). Please contact your local AMO office or representative for region-specific phone numbers. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 11-2 12 SPECIFICATIONS Physical Specifications Environmental Specifications Electrical Specifications Diathermy Specifications Irrigation and Aspiration Specifications Phacoemulsification Specifications Vitrectomy Specifications Diathermy Power Graphs Diathermy Power versus Load Impedance Phaco Power Graphs WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 12-1 12 • Specifications Physical Specifications Table 12.1 – System Physical Specifications English / U.S. WHITESTAR SIGNATURE™ System Console: Console Dimensions (with Width 24 inches display) Depth 24 inches Height Metric: 61 cm 61 cm 54 inches 137 cm Power Cord Length 20 feet 6 meters Electrical Enclosure Current Leakage IEC 60601-1 compliance UL 60601-1 Weight (including IV pole) Footpedal: Single Linear 195 pounds 88.5 kg Width 12 inches 31 cm Length 10.5 inches 27 cm Height 5.5 inches 14 cm 10.0 pounds 4.5 kg Width 10.5 inches 27 cm Length 14 inches 36 cm Height 5.5 inches 14 cm Weight 15 pounds 7 Kg Cord Length Power IV Pole: Maximum Travel 11.8 feet 36 cm 41 inches 107 cm Velocity 2.4 inches/sec 6 cm/sec. Maximum Lift Weight 2.43 pounds 1.1 kg Width 5 inches 13 cm Length 5 inches 13 cm Height 1.5 inches 4 cm Weight 2.0 pounds .9 kg Dimensions Weight Advanced Control Pedal (Dual Linear) Dimensions Wireless Remote Control WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 12-2 12 • Specifications Environmental Specifications Table 12.2 – Environmental Specifications Environmental Specifications Operating Temperature 10 to 40°C Humidity Up to 95% RH, non-condensing Storage/Transportation Conditions Storage Temperature -20 to 60°C Humidity Up to 95% RH, non-condensing Electrical Specifications System Table 12.3 – Electrical Specifications Voltage Frequency Rated Power Fuse Rating 100/120/240 Vac 50/60 Hz 750 VA 6.3A, 250V, Bussman GDA Diathermy Specifications Enclosure Current Leakage <500 uA Table 12.4 – Diathermy Specifications Diathermy Specifications Irrigation and Aspiration Specifications IA Specifications Peristaltic Pump Venturi Pump Power Adjustment 5 to 100%, in 5% increments Diathermy Power (maximum power into rated load) 8.5 Watts into 350 ohms 386 KHz Diathermy Type Bipolar Table 12.5 – Irrigation and Aspiration Specifications Vacuum Level 0–650 mmHg in 5 mmHg increments Pump Flow 0 to 60 cc/minute Vacuum Level 0-600 mmHg in 5 mmHg increments WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 12-3 12 • Specifications Phacoemulsification Specifications Table 12.6 – Phacoemulsification Specifications Phacoemulsification Specifications Peristaltic Pump Venturi Pump Vitrectomy Specifications Phaco Power 0 to 100%, in 5% increments Vacuum Level 0–650 mmHg in 5 mmHg increments Pump Flow Rate 0 to 60 cc/minute Vacuum Level 0-600 mmHg in 5 mmHg increments Table 12.7 – Vitrectomy Specifications Vitrectomy Specifications Peristaltic Pump Venturi Pump WHITESTAR SIGNATURE™ System Vacuum Level 0–650 mmHg in 5 mmHg increments Pump Flow Rate 10 to 60 cc/minute, in 2 cc increments Vacuum Level 0-600 mmHg in 5 mmHg increments Rx Only – Z370147 Rev. C 1108 12-4 12 • Specifications Diathermy Power Graphs Table 12.8 – Diathermy Output Power (Typical) 50 Ohm Diathermy Output Power (Typical) 50 Ohm Output Power (Watts) +/- 20% 4.5 3.5 2.5 1.5 0.5 10 20 30 40 50 60 70 80 90 100 Control Panel Settings (%) WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 12-5 12 • Specifications Table 12.9 – Diathermy Output Power (Typical) 100 Ohm Diathermy Output Power (Typical) 100 Ohm Output Power (Watts) +/- 20% 10 20 30 40 50 60 70 80 90 100 Control Panel Settings (%) WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 12-6 12 • Specifications Table 12.10 – Diathermy Output Power (Typical) 200 Ohm Diathermy Output Power (Typical) 200 Ohm Output Power (Watts) +/- 20% 10 20 30 40 50 60 70 80 90 100 Control Panel Settings (%) WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 12-7 12 • Specifications Table 12.11 – Diathermy Output Power (Typical) 500 Ohm Diathermy Output Power (Typical) 500 Ohm Output Power (Watts) +/- 20% 10 20 30 40 50 60 70 80 90 100 Control Panel Settings (%) WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 12-8 12 • Specifications Table 12.12 – Diathermy Output Power (Typical) 1000 Ohm Diathermy Output Power (Typical) 1000 Ohm Output Power (Watts) +/- 20% 10 20 30 40 50 60 70 80 90 100 Control Panel Settings (%) WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 12-9 12 • Specifications Diathermy Power versus Load Impedance Table 12.13 – Diathermy Output Power (50% Setting) Diathermy Output Power (50% Setting) Output Power (Watts) +/- 20% 100 200 300 400 500 600 700 800 900 1000 Load Resistance (Ohms) WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 12-10 12 • Specifications Table 12.14 – Diathermy Output Power (100% Setting) Diathermy Output Power (100% Setting) Output Power (Watts) +/- 20% 100 200 300 400 500 600 700 800 900 1000 Load Resistance (Ohms) WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 12-11 12 • Specifications Table 12.15 – Diathermy Voltage Diathermy Voltage 160 Output Voltage (Volts) +/- 20% 140 120 100 80 60 40 20 10 20 30 40 50 60 70 80 90 100 Control Panel Settings (%) WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 12-12 12 • Specifications Phaco Power Graphs Table 12.16 – Longitudinal Phaco Power Phaco Power (Longitudinal) Output Power (Watts) +/- 20% 25 20 15 10 10 20 30 40 50 60 70 80 90 100 Control Panel Settings (%) WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 12-13 12 • Specifications Table 12.17 – Ellips™ Phaco Power Ellips™ Phaco Power Output Power (Watts) +/- 20% 25 20 15 10 10 20 30 40 50 60 70 80 90 100 Control Panel Settings (%) WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 12-14 12 • Specifications Table 12.18 – Ellips™ Phaco Power and Longitudinal Phaco Power Pow er Output (Watts) 40.00 35.00 30.00 Watts 25.00 Ellips™ Phaco 20.00 Longitudinal 15.00 10.00 5.00 0.00 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Displayed % Pow er WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 12-15 12 • Specifications Table 12.19 – Ellips™ Phaco Power Linear Mode Ellips™ Power (in Linear Mode) Depending Upon User Defined Max Power Setting 25.00 Delivered Power (Watts) 0% 10% 20.00 20% 30% 15.00 40% 50% 60% 10.00 70% 80% 5.00 90% 100% 90 .0 0% 10 0. 00 80 .0 0% 70 .0 0% 60 .0 0% 50 .0 0% 40 .0 0% 30 .0 0% 20 .0 0% 0. 00 10 .0 0% 0.00 Footpedal P3% Depression WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 12-16 13 ACCESSORIES AND PARTS REORDERING List of Accessories with Part Numbers WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 13-1 13 • Accessories and Parts Reordering Table 13.1 – WHITESTAR SIGNATURE™ System Part Number Name WHITESTAR SIGNATURE™ Console List of Accessories with Part Numbers Description An ophthalmic microsurgical system. Part No. NGP680300 The following table is a list of accessories that you can use to reorder parts for your WHITESTAR SIGNATURE™ System. Your AMO representative can advise you of recommended inventory levels based on the volume of phacoemulsification procedures done in your facility. All of the items listed below are ordered through your AMO representative or directly through AMO Customer Service. Table 13.2 – Accessories and Parts List System Accessories Description Part No. Phaco Handpiece AMO® Phaco Handpiece SOV680290 WHITESTAR® Phaco Handpiece, Coaxial 690697 Ellips™ Phaco Handpiece 690858 19 Gauge LAMINAR™ Flow Phaco Tip, 0° Round Tip OPOR0019L 19 Gauge LAMINAR™ Flow Phaco Tip, 15° Round Tip OPOD1519L 19 Gauge LAMINAR™ Flow Phaco Tip, 30° Round Tip OPOD3019L 19 Gauge LAMINAR™ Flow Phaco Tip, 45° Round Tip OPOD4519L Disposable 20 Gauge LAMINAR™ Flow Phaco Tip, 0° Round Tip OPOD0020L Disposable 20 Gauge LAMINAR™ Flow Phaco Tip, 15° Round Tip OPOD1520L Disposable 20 Gauge LAMINAR™ Flow Phaco Tip, 30° Round Tip OPOD3020L Disposable 20 Gauge LAMINAR™ Flow Phaco Tip, 45° Round Tip OPOD4520L Disposable LAMINAR™ Flow Phaco Tip, 19 Gauge, 30° Curved OPOCR3019L Disposable LAMINAR™ Flow Phaco Tip, 20 Gauge, 30° Curved OPOCR3020L 19 Gauge LAMINAR™ Flow Irrigation Sleeve and Test Chamber OPOS19L Disposable 20 Gauge LAMINAR™ Flow Infusion Sleeve and Test Chamber OPOD20L WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 13-2 13 • Accessories and Parts Reordering System Accessories I/A Handpiece WHITESTAR SIGNATURE™ System Description Part No. LAMINAR™ Flow Tip Wrench OPOMTWL SOLO™ I/A Handpiece, 20 Ga., Curved Silicone Sleeve Tip OPOIA20CRV SOLO™ I/A Handpiece, 20 Ga., 45° Silicone Sleeve Tip OPOIA2045D SOLO™ I/A Handpiece, 20 Ga., Straight Silicone Sleeve Tip OPOIA20STR SOLO™ I/A Handpiece Kit OPOIA20KIT PHACOFIT™ OM055002 Titanium Handle PHACOFIT™ I/A Tip Curved .5 mm Port OM05510110 PHACOFIT™ O-Ring's I/A Tip (5PK) OM05510112 PHACOFIT™ Titanium, Multi-Tip Set OM05510113 PHACOFIT™ Cleaning/Flushing Kit OM05510114 PHACOFIT™ Tip, Luer Adapter (Aspiration) OM05510115 PHACOFIT™ Tip, 45 Degree Silicone (No Sleeve) OM05510116 PHACOFIT™ I/A Tip Straight .3MM Port OM0551011 PHACOFIT™ I/A Tip Curved .3 mm Port OM0551012 PHACOFIT™ I/A Tip 45 Degree 0.3 mm Port OM0551013 PHACOFIT™ I/A Tip 90 Degree 0.3 mm Port OM0551014 PHACOFIT™ I/A Tip Binkhorst 0.3 mm Port OM0551015 PHACOFIT™ I/A Tip Straight SI 0.3 mm Port OM0551016 PHACOFIT™ I/A Luer Adapter, F/F OM0551017 PHACOFIT™ I/A Tip Curved, SI, .3 mm Port OM0551018 PHACOFIT™ I/A Tip Straight .5MM Port OM0551019 PHACOFIT™ Athlete I/A Tip Straight Type OM0551020J PHACOFIT™ Athlete I/A Tip 45 Degree Type OM0551021J DUET™ STARTER KIT, 20GA DUA02020 Rx Only – Z370147 Rev. C 1108 13-3 13 • Accessories and Parts Reordering System Accessories Description Part No. DUET™ ASPIRATION HANDLE DU02100 DUET™ IRRIGATION HANDLE DU02200 DUET™ 20G CURVED IRRIGATOR CLOSED END DU02301 DUET™ 20G CURVED ASPIRATION .3MM PORT CAP POL DU02302 DUET™ 19G FINE IRRIGATING CHOPPER DU02303 DUET™ 20G OLSON II IRRIGATING CHOPPER DU02305 DUET™ MST Aguirre Duet Tip DU02325 DUET™ MST Fine/Nagahara Tip DU02335 Bipolar Cord with Fischer Connection K106075 Bipolar Forceps, Curved Iris 0.5 mm Tip K121085 18 Gauge Straight Diathermy Pencil, reusable K147000 20 gauge Vitreous Cutter NGP0020 23 gauge Vitreous Cutter NGP0023 25 gauge Vitreous Cutter NGP0025 Fusion™ Tubing Pack (disposable, sterile) OPO70 Fusion™ Dual Pump Tubing Pack (disposable, sterile) OPO71 Wireless Remote Control WHITESTAR SIGNATURE™ System Remote Control NGP680135 Footpedal WHITESTAR SIGNATURE™ Foot Pedal (Single Linear) NGP680701 Advanced Control Pedal for the WHITESTAR SIGNATURE™ (Dual Linear) NGP680702 Power Cord, Hospital Grade, 20 ft., 6.1 meters 2410-0049-L Footpedal Cable to WHITESTAR SIGNATURE™ System 0100-0055 WHITESTAR SIGNATURE™ Dust Cover 0100-0750 Sterilization Tray MSR309 WHITESTAR SIGNATURE™ System Owner's Manual (English) NGP Z370147 Diathermy Handpiece Vitrectomy Cutter FUSION™ Tubing Pack Miscellaneous WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 13-4 13 • Accessories and Parts Reordering System Accessories WHITESTAR SIGNATURE™ System Description Part No. WHITESTAR SIGNATURE™ System Owner's Manual (Chinese) NGP Z370161 WHITESTAR SIGNATURE™ System Owner's Manual (Korean) NGP Z370163 WHITESTAR SIGNATURE™ System Owner's Manual (Japanese) NGP Z370162 WHITESTAR SIGNATURE™ System Owner's Manual (French) NGP Z370148 WHITESTAR SIGNATURE™ System Owner's Manual (German) NGP Z370150 WHITESTAR SIGNATURE™ System Owner's Manual (Swedish) NGP Z370157 WHITESTAR SIGNATURE™ System Owner's Manual (Finnish) NGP Z370160 WHITESTAR SIGNATURE™ System Owner's Manual (Portuguese) NGP Z370152 WHITESTAR SIGNATURE™ System Owner's Manual (Italian) NGP Z370149 WHITESTAR SIGNATURE™ System Owner's Manual (Spanish) NGP Z370151 WHITESTAR SIGNATURE™ System Owner's Manual (Danish) NGP Z370158 WHITESTAR SIGNATURE™ System Owner's Manual (Dutch) NGP Z370153 WHITESTAR SIGNATURE™ System Owner's Manual (Greek) NGP Z370156 WHITESTAR SIGNATURE™ System Owner's Manual (Norwegian) NGP Z370159 WHITESTAR SIGNATURE™ System Owner's Manual (Polish) NGP Z370154 WHITESTAR SIGNATURE™ System Owner's Manual (Russian) NGP Z370155 WHITESTAR SIGNATURE™ System Owner's Manual CD, Multilingual NGP Z370164 Rx Only – Z370147 Rev. C 1108 13-5 GLOSSARY Term Active Reflux Definition Reflux that occurs in response to a user request (typically by way of the footpedal). Active State The state where the instrument responds to the footpedal in all zones. All the surgical modes are operative. Active Vacuum Vent The vacuum is relieved by a controlled reversal of the peristaltic pump or by the vacuum regulator. Advanced Control Pedal (Dual Linear) A footpedal for the WHITESTAR SIGNATURE™ Phacoemulsification System that operates in two independent linear movement planes (Pitch and Yaw). The two linear movement planes provide proportional control of user-defined functions. Anterior Chamber A fluid filled space inside the eye between the iris and the innermost corneal surface. Anterior Mode The Anterior function operating mode of the instrument. Anterior Segment The front third of the globe; includes structures located between the front surface of the cornea and the vitreous. Aspiration Removal of fluid from the eye using the pumps. Aspiration Line Fluids pathway within he handpiece that is utilized to extract fluid and tissue from the eye. Burst Mode One of the available options on the WHITESTAR SIGNATURE™ System for phaco power delivery. Characterized by short periods of time where the power is turned on, interspersed with off times. CASE ChAmber Stabilization Environment is an intelligent vacuum system that monitors occlusions and adjusts the vacuum to prevent or reduce post occlusion surge or chamber collapse. Cassette The tubing packs that are installed on the system to connect the tubing on the hand pieces to the vacuum and irrigation sources in the instrument. Compatible Surgeon Programs Programs that have the same Pack Type, Pump Type, and Infusion method. Continuous Phaco Power One of the available Phaco power delivery modes. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 Glossary-1 Glossary Term Controller Definition A processor or microcontroller that is programmed to fulfill a specific task. It can be anything from a small 8-bit microprocessor to a PCcompatible system. On the WHITESTAR SIGNATURE™ system, the following controllers have been identified: GUI Host Processor, Instrument Host Processor, Fluidics Controller, Phaco-Diathermy (PD) Controller, Pneumatic Controller, Diagnostic Controller, IV Pole Controller, Remote Controller, Touch Screen Controller, Footpedal Controller, Footpedal Wireless Controller, Remote Wireless Controller, and Sound Controller. Continuous Burst Phaco Power One of the available Phaco power delivery modes. Diathermy Method used to coagulate blood vessels during a cataract procedure and to join together the conjunctiva at the end of a cataract procedure using electrical current. DLL Dynamic Link Library. A collection of software routines that can be loaded and accessed at run time. Ellips™ Technology A technology that provides both longitudinal and transverse movement within the Ellips™ handpiece. EMI Electromagnetic Interference. Emitted by electrical circuits carrying rapidly changing signals, as a by-product of their normal operation, and which causes unwanted signals (interference or noise) to be induced in other circuits. Evacuation The removal, by suction, of fluids from the eye cavity through a phacoemulsification ultrasonic handpiece. Extraction The process or act of pulling or drawing out fluids from the eye cavity during Phacoemulsification surgery. Fluidics The components and aspects of the system involving fluid; specifically, irrigation, aspiration, vacuum, pressure and their performance as interdependent systems. FPn Foot Pedal zone position (0, 1, 2, or 3). The zone changes when the footpedal is pressed. FUSION™ The screen in which the Occlusion mode, CASE mode, and Actual Maximum Vacuum settings can be modified. FUSION™ Fluidics Pack (OPO70) The fluidic tubing pack which interfaces only with the peristaltic pump related components. FUSION™ Dual Pump Pack (OPO71) The FUSION™ dual pump fluidic tubing pack which interfaces with both the peristaltic and the vacuum-based pump related components. Gravity Infusion The bottle height-induced irrigation when the IV pole is positioned at a specific height. GUI Graphical User Interface. Used to reference the interface presented to the user on a graphical screen. High Power Pulse Phaco Power One of the available Phaco power delivery modes. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 Glossary-2 Glossary Term IV Pole Definition The programmable pole used to position the irrigation solution during the phacoemulsification process. I/A A general term for Irrigation/Aspiration, and a specific footpedal configuration. IAC A Vitrectomy mode that uses the Irrigation, Aspiration, and Cutting sequences as the footpedal is pressed. ICA A Vitrectomy mode that uses the Irrigation, Cutting, and Aspiration sequences as the footpedal is pressed. Irrigation Causing fluid to be moved into/toward the eye via the irrigation line. Irrigation Line The fluid path within the handpiece that is used to allow the clean balanced salt solution to travel from the bottle into the eye. LCD The Liquid Crystal Display on the WHITESTAR SIGNATURE™ System. Linear Variable Any switch on the footpedal that is used for Linear control. (Pitch or Yaw.) Long Pulse Phaco Power One of the available Phaco power delivery modes. Low Power Pulse Phaco Power One of the available Phaco power delivery modes. Max Vac (Maximum Vacuum) The value for a vacuum based fluidic is the lesser of 600 mmHg or 85% of the CASE Upper Threshold. The maximum value for a peristaltic pump is 650 mmHg. Motor Venting Used with both the FUSION™ Fluidics pack (OPO70) and the Dual Linear (OPO71) pack. Driving the peristaltic pump in the reverse direction to vent. Multiple Burst Phaco Power One of the available Phaco power delivery modes. NiMh Nickel-Metal Hydride. A type of rechargeable battery. One-Touch CASE The ability to alter the CASE settings with a single press of a button. The modes are +2, +1, Standard, -1, -2. Operating Mode The current operating mode of the instrument. The modes are Phaco, I/A, Vitrectomy, and Diathermy. Pairing The process of matching two BlueTooth® Devices, the console and the remote control or the console and the wireless foot pedal, so that they can communicate with one another. Pars Plana Incision A surgical cut into the eyeball that passes through the sclera and the pars plana area of the cilary body, between the pars plans and the ora serrata. Common site for instruments used for Vitrectomy procedures. Passive Reflux A small reflux from the aspiration line that occurs automatically when the system vents. Historically, this has occurred on AMO® systems that utilize valve venting. Peristaltic A flow based pump. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 Glossary-3 Glossary Term Phacoemulsification / Phaco Definition The term is abbreviated as Phaco. Phaco is a cataract extraction technique originally developed by Dr. Charles Kelman. To use this technique, a surgeon makes a small incision in the eye and emulsifies the cataract with the help of a vibrating needle inserted through the incision. The emulsified particles of the cataract are gently aspirated through the needle while the surgeon continues to irrigate the eye's chamber to maintain intraocular pressure (IOP). Pitch The vertical travel of the footpedal. Pneumatics Components and aspects of the system involving high and low pressure and vacuum. Post Occlusion Surge A result of rapidly changing pressures within the anterior chamber of the eye. The fluid surge is caused when the Phaco Tip is blocked during a procedure and is suddenly cleared. The surge can cause an imbalance of fluids leaving the eye and potential damage to the eye tissue. Power Boost Mode An operating mode in which the yaw movement of the Advanced Control Pedal (Dual Linear Footpedal) is utilized to provide a temporary increase (Boost) in phaco power. Primary Venting Mechanism A venting mechanism (valve, motor) selected by the host software as the preferred means of performing venting. Programming Mode (System Configuration) When the system is not Primed/and not Tuned Phaco, I/A, and Vitrectomy surgical modes are not available. However, the user can program and update surgical and system settings. Pump Ramp A characteristic of the peristaltic pump that determines the point at which the pump speed is decreased in order to maintain a manageable rate of vacuum rise. Pulse Shape A feature of WHITESTAR® Technology which allows the user to define a "kick" of increased power at the beginning of a WHITESTAR® pulse over a range of Phaco power settings. Reflux Fluid that is moved into/toward the eye via the aspiration port/line. The reverse flow within the aspiration line that can be used to release or dislodge unwanted material from the handpiece tip or to “tent” the incision site to allow easier tip insertion. Reflux is not intended to clear a clogged handpiece. However, reflux can be used to identify a blockage. Remote Control A user interface control for the GUI system through a wireless connection. The Remote Control commands are interpreted to control the GUI software. Safe State A state where the Phaco, Vitrectomy, Diathermy, and fluidics functions are disabled, with irrigation on and the fluid vented. The instrument the footpedal is disabled. As a result, all of the surgical modes become inoperable. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 Glossary-4 Glossary Term Secondary Venting Mechanism Definition A venting mechanism (valve, motor or vacuum regulator) automatically used by the system to attempt venting if the primary venting mechanism should fail. Short Pulse Phaco Power One of the available Phaco power delivery modes. Single Burst Phaco Power One of the available Phaco power delivery modes. Single Linear Footpedal A footpedal with only one plane of travel allowing proportional control of system parameters. SubMode A submode is a defined set of parameters for the current mode. Most operating modes have multiple submodes. For example, there are three I/A submodes for Anterior surgery, each of which contains a set of potentially different parameters for the I/A mode. Surgical Media Center (SMC) An optional accessory product that can be connected to the WHITESTAR SIGNATURE™ system to generate and record video images of the surgery. The video images contain embedded information about the instrument status and settings throughout the surgical procedure. System A hardware unit and associated peripherals including software required to perform a specific function. Tenting the Incision (Wound) Using reflux while inserting the handpiece into the eye. This technique causes the incision (wound) to open slightly (tent), thus making handpiece insertion easier. Touch Screen The display surface of the Liquid Crystal Display (LCD) that responds to touch. Vacuum Boost Mode An operating mode in which the yaw movement of the Dual Linear Footpedal is utilized to provide a temporary increase (Boost) in the maximum vacuum. Vacuum Regulator Venting Using the vacuum regulator in the WHITESTAR SIGNATURE™ system to vent the vacuum in the OPO71 vacuum tank. Used only with the Venturi pump. Valve Reflux The fluid flows back through the pinch valve. Valve Vent The vacuum is vented through the aspiration line. Valve Venting Used with OPO70 pack only. Manipulation of the fluidic connections to cause fluid from the irrigation bottle to be directed toward the aspiration port in order to vent. Typically this results in passive reflux. Variable WS A mode where the user can define the WHITESTAR® Technology delivery based on the footpedal position. Venting Relieving vacuum in the aspiration tube. Typically venting is performed when the Footpedal is moved from position 2 into position 1 or 0. Venturi A vacuum based pump. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 Glossary-5 Glossary Term Vitrectomy Definition The removal of vitreous with a needle-like cutter that has fluid injection and suction capabilities. WHITESTAR® Technology A proprietary software technology that is used to deliver finely modulated pulses of energy, interrupted by extremely brief cooling periods. Yaw The horizontal movement of the footpedal that works from either the left or the right of the footpedal. Yaw Threshold The programmed yaw movement that is allowed before the yaw switch is activated on the footpedal. WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 Glossary-6 INDEX Accessories 13-1 Add a Surgeon 6-3 Adjusting Cut Rates 5-29 Flow Rate 5-28 Advanced Control Pedal Does Not Pair 10-17 Dual Linear 1-4, 3-11, 3-22, 7-4, 9-5, 12-2 Modes Vitrectomy 5-20 Pitch Thresholds 5-31 VIT 5-32 Settings Dual Linear 5-19 Wireless 3-22 Anterior chamber too deep 10-18 Anterior Segment Settings 5-37 Surgery 3-15 Anterior Segment Surgery 5-1 Aspiration Specifications 12-3 Troubleshooting 10-19 Aspiration Flow Rate 5-28 Aspiration Rate Occlusion 5-45 PHACO 5-7 Vitrectomy 5-17 Assign Order 6-14 Autoclave 9-4 Backlight button 10-16 Balance Irrigation/Aspiration 4-10 balanced salt solution 3-19 batteries footpedal 3-22, 9-5 remote control 3-26 Battery Location Wireless Foot Pedal 10-4 Replacement Wireless Foot Pedal 10-3 Begin Tune 4-9 blocked aspiration port 5-47 Bluetooth® 10-16 Bluetooth® devices 10-17 Bottle Height IA 5-25 PHACO 5-26 Vitrectomy 5-27 Burst 5-3 Bypass 4-7, 4-11 WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 Index-1 Index Calibration Touch Screen 7-7 Wireless Foot Pedal 7-5 Care of the System 9-5 CASE 5-7 CASE Lower Threshold PHACO 5-26 CASE Mode 5-41 PHACO 5-26 CASE ONE Touch 1-7, 5-43 CASE Upper Threshold PHACO 5-26 CASE Vac PHACO 5-26 CASE Vacuum 5-16 Cassette Loading 3-18 Chamber partially collapses 10-19 Changing Irrigation 3-3 Mode Parameters 4-12 charging the footpedal 9-5 Check-out 8-2 Irrigation/Aspiration 8-2 Phacoemulsification 8-2 Vitrectomy 8-3 Cleaning Handpiece 9-2 System 9-5 Common Problems 10-5 Complete Setup 3-19 Components 2-2 Configuration 4-12 Connecting Handpieces 3-3 Connections Rear Panel 3-16 Console Dimensions 12-2 Continuous Burst 5-37 PHACO Power 5-40 WHITESTAR SIGNATURE™ System Continuous Irrigation 1-5, 4-7, 5-6 Cup Fill 4-9 IA 5-25 PHACO 5-26 Continuous Phaco Power 5-38 Continuous Power 5-37 Controls Screens 4-2 Copy a Program 6-10 Cup Fill 4-7, 4-9 Custom Duty Cycles 5-11 Cut Rate Adjusting 5-29 Vitrectomy 5-17, 5-27 cuts per minute 5-29 Cutter Vitrectomy 3-21 Cutting Rates Vitrectomy 5-29 Database 4-2 Delete 6-13 Management 7-2 Program 6-14 Restore 6-13 Default Program 4-6, 5-21 Default Settings Diathermy 5-24 Footpedal 5-23 Irrigation/Aspiration 5-25 PHACO 5-26 Sound 5-22 Vitrectomy 5-27 Delete Database 6-13 Program 6-12, 6-13 Surgeon 6-11 DIA time 5-3 Diagnostics 4-2, 7-2, 10-1 Rx Only – Z370147 Rev. C 1108 Index-2 Index Diathermy 1-6, 3-4, 5-2 Default Settings 5-24 Forceps 3-21 Handpiece 9-3 Part Numbers 13-4 Output Power 12-10 Pencil Probe 3-21 Power 12-10 Power Graphs 12-5 Specifications 12-3 Troubleshooting 10-20 Using 5-3 Voltage 12-12 Dimensions 12-2 drainage bag 3-18 DT 5-3 Dual Linear Advanced Control Pedal 1-4, 3-11, 3-22, 5-31, 7-4, 9-5, 12-2 Settings 5-19 Settings Advanced Control Pedal 5-19 VIT Footpedal Settings 5-32 Dual Linear Foot Pedal does not pair 10-17 Dual Pump 1-5 Duty Cycles 5-9 PHACO 5-27 Edit Program 6-9 Surgeon 6-5 Effective Phaco Time 5-35 Electrical Specifications 12-3 Ellips™ 1-4 Handpiece 1-4, 3-17 Technology 5-48 End Case 4-2, 5-34 Environmental Specifications 12-3 EPT 5-35 Equipment Operation 4-1 Error Message 10-2 WHITESTAR SIGNATURE™ System Error Messages 10-5 failed to pair 10-16 Feedback Footpedal 5-24 Flash Sterilization 9-4 Flow Rate Adjusting 5-28 Fluidics 1-4 Error Messages 10-5 Mode PHACO 5-26 Foot Pedal Battery Replacement 10-3 Calibration 7-5 Pitch Advanced Control Pedal 5-31 Pitch Thresholds single linear 5-30 Settings single linear 5-19 Single Linear 1-4 wireless 3-4 Footpedal 1-4, 3-22, 4-2 Advanced Control Pedal 3-11 charging 9-5 Dual Linear Advanced Control 3-11 Feedback 5-24 Modes Vitrectomy 5-20 Part Number 13-4 Pitch 3-23 Pitch Regions 5-24 Positions 3-23, 5-11 Settings 5-23, 5-30 Setup Wireless 7-3 Single Linear 3-22 Specifications 12-2 Rx Only – Z370147 Rev. C 1108 Index-3 Index Summary single linear 5-23 Switch Assignment 5-32 Threshold 5-24 Vitrectomy 5-17, 5-27 Wireless 1-4, 3-22 Forceps 11-2 Diathermy 3-21 Fuse Location 10-3 Replacement 10-2 Fusion 5-15, 5-44 FUSION™ 2-4 FUSION™ Tubing Pack Part Number 13-4 IA Gas Sterilization 5-28, 9-4 General Troubleshooting 10-15 Graph Phaco Power 12-13 Graphic User Interface 1-5 Graphs Diathermy Power 12-5 Gravity Displacement Sterilization 9-4 GUI 1-5 Handpiece Cleaning 9-2, 9-3 Connecting 3-3 IA 3-18 Phaco 3-20 Priming 4-8 Ultrasonic 3-3 Warranty 11-2 Help 10-2 High Power Limit 5-14 Pulse 5-37 PHACO Power 5-39 WHITESTAR SIGNATURE™ System Handpiece 3-18 Submodes 5-5 IAC 5-20 ICA 5-20 ICE Pulse Shaping WHITESTAR® 5-14 Infusion Sleeve 2-4 Initial Mode 5-8, 5-24, 5-25, 5-28 Inspection Instructions 2-2 Install Tubing Cassette 4-6 Irrigation Changing 3-3 Continuous 4-7, 5-6 flow does not stop 10-18 Inadequate 3-3 Specifications 12-3 Troubleshooting 10-18 Irrigation/Aspiration 1-7, 5-4 Balance 4-10 Check-out 8-2 Default Settings 5-25 IV Pole does not work 10-17 Programmable 3-4, 3-25, 5-4 kick 5-14 LAMINAR™ Flow 3-18 Linear 5-2, 5-3, 5-28 Occluded Power 5-47 List of Accessories 13-1 Load Impedance 12-10 Resistance 12-10 Locked Program 6-13 Logs 7-2 Rx Only – Z370147 Rev. C 1108 Index-4 Index Long Pulse PHACO Power 5-38 Power 5-37 Rate PHACO 5-26 Low batteries 10-16, 10-17 Low Power Limit 5-14 Pulse 5-37 PHACO Power 5-39 Lower Threshold 5-16 Maintenance 4-2, 11-2 Touch Screen 7-7 Max Aspiration IA 5-25 Rate Occluded PHACO 5-27 PHACO 5-26 Vitrectomy 5-27 Max Phaco Power Occluded PHACO 5-27 Unoccluded PHACO 5-27 Max Power Diathermy 5-24 Max Vacuum 5-9 IA 5-25 PHACO 5-26 Vitrectomy 5-27 maximum vacuum 5-15 Mayo Stand Drape 2-4 Messages Error 10-2 Miscellaneous Part Numbers 13-4 Mode Programming 1-6 Modes Changing Parameters 4-12 How to program 5-21 Monitor Drape 2-4 WHITESTAR SIGNATURE™ System Multiple Burst PHACO Power 5-39 Power 5-37 Multiple Mode Programming 1-6 NiMH 3-22, 10-3 No aspiration 10-19 No diathermy or poor diathermy 10-20 No irrigation flow 10-18 No phacoemulsification 10-20 No sound when using diathermy 10-20 No vacuum 10-19 No vitrectomy cutting 10-21 Occluded Aspiration Rate 5-44 Occluded Phaco 5-7 Occlusion Aspiration Rate 5-45 Threshold 5-9 PHACO 5-26 Vacuum Threshold 5-45 Venting 5-47 OCCLUSION MODE™ Phaco Settings 5-26, 5-41, 5-44 Off Time 5-27 On Time 5-27 ONE Touch CASE 5-43 Operating Modes 1-6 Anterior Segment 5-1 Operating the Equipment 4-1 Output Power Diathermy 12-10 Override Settings 5-40 Rx Only – Z370147 Rev. C 1108 Index-5 Index pair Advanced Control Pedal 10-17 Dual Linear Foot Pedal 10-17 Wireless Remote Control 10-16 Pairing Instruction Wireless Remote Control 7-6 Pairing Instructions Wireless Foot Pedal 7-4 Panel 5-2, 5-3, 5-28 Occluded Power 5-47 Parameter Settings WHITESTAR® Technology 5-10 Parameters Programming 1-6 Part Numbers 13-2 Parts Reordering 13-1 Passive Reflux 5-48 Pencil Probe Diathermy 3-21 Percent Kick High End of Range 5-14 Low End of Range 5-14 Peristaltic Pump 12-3 PHACO Default Settings 5-26 Program 5-8 Submodes 5-7 Using 5-8 Phaco Handpiece 1-4, 3-4, 3-17, 3-20, 9-2 Part Numbers 13-2 PHACO Power 5-37 Phaco Power 5-7 Continuous 5-38 Graph 12-13 Phacoemulsification 1-2, 1-7, 3-3, 3-16, 5-6, 5-7, 8-3, 10-20, 12-4 Check-out 8-2 Specifications 12-4 Troubleshooting 10-20 Physical Specifications 12-2 PITCH 3-23 WHITESTAR SIGNATURE™ System Pitch Regions Footpedal 5-24 Poor aspiration 10-19 Poor phacoemulsification 10-20 Positions Footpedal 3-23 Power Continuous 5-37 Continuous Burst 5-37 Delivery Diathermy 5-24 PHACO 5-26, 5-27 Failure 3-3 High Pulse 5-37 Long Pulse 5-37 Low Pulse 5-37 Multiple Burst 5-37 PHACO 5-7 Phaco 5-37 Short Pulse 5-37 Single Burst 5-37 Switch 10-5 Power Cord Length 12-2 pps 5-38 Precautions 8-2 Safety 3-2 Preferred Program 6-6 Prevacuum Sterilization 9-4 Prime Bypass 4-7 Prime/Tune 1-5, 4-2, 4-7, 4-8, 4-9, 5-3, 8-2 Priming Handpiece 4-8 Vitrectomy 4-11 Problems Common 10-5 Rx Only – Z370147 Rev. C 1108 Index-6 Index Program 4-2 Assign Order 6-14 Configuration 5-21 Database 6-14 Defaults 5-21 Delete 6-12 Edit 6-9 Lock 6-13 Locked 6-13 Preferred 6-6 Programmable IV Pole 1-6, 3-4, 3-19, 3-25, 5-4 Specifications 12-2 Programming Multiple Mode 1-6 PHACO 5-8 Programs Select 4-4 Surgeon 6-1 Pulse Off Time 5-10 Pulse On time 5-10 Pulse Rate 5-10 Pulse Shaping 5-12 pulses per second 5-38 Pump not working 10-19 Pump Ramp PHACO 5-26 Threshold IA 5-25 Rear Panel 3-16 Recording Mode 3-28 Reduced/insufficient irrigation flow 10-18 Reflux 3-24 Passive 5-48 Remote Control 3-4 Wireless 3-26, 7-6 Remote Pair 7-6 Reordering Parts 13-1 Replacing Batteries 10-2, 10-3 Replacing the Fuse 10-2 WHITESTAR SIGNATURE™ System Reset Timers 4-10 Restore Database 6-13 Restriction of Hazardous Substances 3-14 RoHS 3-14 Safety Precautions 3-2 Screens Controls 4-2 Select Program 4-6 Selecting a Language 4-3 Self Test 4-4 Settings Anterior Segment 5-37 Footpedal 5-30 How to program 5-21 Occlusion Mode 5-44, 5-47 OCCLUSION MODE™ Phaco 5-41 Override 5-40 Submode Parameters 5-4 Setup Completion 3-19 Sequence 3-15 System 8-2 Wireless 7-6 Short Pulse PHACO Power 5-38 Power 5-37 Rate PHACO 5-26 Shutdown Sequence 3-29 Side VIT 5-20 Side vitrectomy 5-20 Single Burst PHACO Power 5-39 Power 5-37 Single Linear Foot Pedal 1-4, 12-2 Settings 5-19 Pitch Thresholds 5-30 Rx Only – Z370147 Rev. C 1108 Index-7 Index Sleep Mode 10-16 SMC Surgical Media Center 3-27 SOLO™ 3-18 Sounds 4-2 Default Settings 5-22 Specifications Diathermy 12-3 Electrical 12-3 Environmental 12-3 Footpedal 12-2 Fuse 10-2 IA 12-3 IV Pole 12-2 Phacoemulsification 12-4 Physical 12-2 Vitrectomy 12-4 Start Vit Prime 8-3 Startup 4-4 Status 10-5 STD Surgeon 6-2 Sterilization 3-22, 9-4 Gas 9-4 Gravity Displacement 9-4 Prevacuum 9-4 Storage Conditions 12-3 Submode Parameters 5-4 PHACO 5-7, 5-40 Submodes IA 5-5 PHACO 5-7 Surgeon Add 6-3 Copy 6-10 Delete 6-11 Edit 6-5 Select 6-1 STD 6-2 Surgeon/Program Select 4-4 Surgeons and Programs 4-13 Surgical Media Center SMC 3-27 WHITESTAR SIGNATURE™ System Switch Assignment 5-30 Footpedal 5-32 Symbol Definitions 3-9 System Check-out 8-2 Cleaning 9-5 Console 1-5 Default Settings 5-22 Description 1-2 Disposal 3-12 does not turn on 10-15 Self Test 4-4 Shutdown 3-29 Tests 7-2 Utilities 7-2 Technical Service 10-5 Technology WHITESTAR® 5-9 Test Chamber 2-4, 13-2 Threshold Vacuum 5-45 Timers Reset 4-10 Touch Screen Calibration 7-7 Does not respond 10-17 Using 4-12 Translucency 3-28 Troubleshooting 8-2, 10-1 Aspiration 10-19 Diathermy 10-20 General 10-15 Irrigation 10-18 Phacoemulsification 10-20 Vitrectomy 10-21 Tubing Cassette 2-4 Install 3-18, 4-6 Tune 4-7 Begin 4-9 Rx Only – Z370147 Rev. C 1108 Index-8 Index Vitrectomy 3-4, 3-21, 5-17 Advanced Control Pedal (Dual Linear) Modes 5-20 Check-out 8-3 Cut Rate 5-29 Cutter 3-4 Default Settings 5-27 Footpedal Modes 5-20 Prime 4-11 Specifications 12-4 Troubleshooting 10-21 Using 5-18 VIT 1-7 Voltage Diathermy 12-12 Ultrasonic (U/S) Time 5-35 Ultrasonic Handpiece 3-3 Unoccluded Phaco 5-7 Unpair 10-16 Up Time PHACO 5-26 Threshold 5-16 Upper Threshold 5-16 Using Diathermy 5-3 PHACO 5-8 too much fluid 10-18 Touch Screen 4-12 Vitrectomy 5-18 Vacuum 5-34 monitoring 5-15 PHACO 5-7 pressure 5-47 Rate Linear 5-28 Panel 5-28 Vitrectomy 5-17 Variable WHITESTAR® Technology 5-11 Variable WS 5-11 Venting Occlusion 5-47 Venturi pump 5-16 VIT Foot Pedal Settings dual linear 5-32 Wake-up 3-24 Warnings 3-2, 3-5 Warranty 11-1 Watts 12-5, 12-14 WHITESTAR Decrement 5-32 Increment 5-32 WHITESTAR® ICE Technology 1-3 WHITESTAR® Technology 1-3, 5-9 Wireless Advanced Control Pedal 3-22 Wireless Foot Pedal 3-4 Battery Location 10-4 Calibration 7-5 Wireless Footpedal Pairing 7-4 Setup 7-3 Wireless Remote Control 1-5, 3-4, 3-26 Part Number 13-4 Setup 7-6 wireless remote control does not pair 10-16 Yaw 3-23 WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev. C 1108 Index-9
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