DOCUMENT NO: Z370147 REVISION: C 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.
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.
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.
Table of Contents TABLE OF CONTENTS Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1 About this Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . About Phacoemulsification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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.
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.
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.
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.
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.
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.
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.
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.
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.
2 • System Components Figure 2.1 – WHITESTAR SIGNATURE™ System 1 3 2 4 5 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
3 • System Setup Figure 3.1 – Rear Panel Connections 1 2 3 4 5 6 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.
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 2 3 1. Test Chamber 2. Infusion Sleeve 3. Handpiece with Tip 4.
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 2 4 3 5 1. Infusion Sleeve 2. SOLOTM Straight Tip 3. Handpiece 4. SOLOTM Curved Tip 5.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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) 6 33% Pulse Rate (pps) 55 4/8 4 8 33% 83 6/4 6 4 60% 100 6/8 6 8 43% 71 8/4 8 4 67% 83 4/24 4 24 14% 35 6/28 6 28 18% 29 6/24 6 24 20% 33 8/24 8 24 25% 31 6/18 6 18 25% 41 Figure 5.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
5 • Anterior Segment Surgery Operating Modes AMO Default Setups Sounds Table 5.
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.
5 • Anterior Segment Surgery Operating Modes Table 5.
5 • Anterior Segment Surgery Operating Modes Table 5.
5 • Anterior Segment Surgery Operating Modes Table 5.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
6 • Surgeon Programs Figure 6.7 – Select a Program to Begin Screen WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev.
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.
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.
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.
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.
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.
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.
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.
7 DIAGNOSTICS Diagnostics Wireless Footpedal Setup Wireless Foot Pedal Calibration Wireless Remote Control Setup Calibrate Touch Screen WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev.
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.
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.
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.
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.
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.
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.
8 CHECK-OUT PRECAUTIONS System Check-out WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev.
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.
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.
9 CARE AND CLEANING Cleaning Procedures Sterilization Procedures WHITESTAR SIGNATURE™ System Cleaning and Care WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev.
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.
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.
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.
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.
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.
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.
10 • Error Messages Troubleshooting and Diagnostics Figure 10.1 – Fuse Location 1 2 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
11 WARRANTY AND MAINTENANCE Warranty Statement WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev.
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.
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.
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.
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.
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.
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 4 3.5 3 2.5 2 1.5 1 0.5 0 0 10 20 30 40 50 60 70 80 90 100 Control Panel Settings (%) WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev.
12 • Specifications Table 12.9 – Diathermy Output Power (Typical) 100 Ohm Diathermy Output Power (Typical) 100 Ohm Output Power (Watts) +/- 20% 7 6 5 4 3 2 1 0 0 10 20 30 40 50 60 70 80 90 100 Control Panel Settings (%) WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev.
12 • Specifications Table 12.10 – Diathermy Output Power (Typical) 200 Ohm Diathermy Output Power (Typical) 200 Ohm Output Power (Watts) +/- 20% 8 7 6 5 4 3 2 1 0 0 10 20 30 40 50 60 70 80 90 100 Control Panel Settings (%) WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev.
12 • Specifications Table 12.11 – Diathermy Output Power (Typical) 500 Ohm Diathermy Output Power (Typical) 500 Ohm Output Power (Watts) +/- 20% 9 8 7 6 5 4 3 2 1 0 0 10 20 30 40 50 60 70 80 90 100 Control Panel Settings (%) WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev.
12 • Specifications Table 12.12 – Diathermy Output Power (Typical) 1000 Ohm Diathermy Output Power (Typical) 1000 Ohm Output Power (Watts) +/- 20% 7 6 5 4 3 2 1 0 0 10 20 30 40 50 60 70 80 90 100 Control Panel Settings (%) WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev.
12 • Specifications Diathermy Power versus Load Impedance Table 12.13 – Diathermy Output Power (50% Setting) Diathermy Output Power (50% Setting) Output Power (Watts) +/- 20% 6 5 4 3 2 1 0 0 100 200 300 400 500 600 700 800 900 1000 Load Resistance (Ohms) WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev.
12 • Specifications Table 12.14 – Diathermy Output Power (100% Setting) Diathermy Output Power (100% Setting) 9 Output Power (Watts) +/- 20% 8 7 6 5 4 3 2 1 0 0 100 200 300 400 500 600 700 800 900 1000 Load Resistance (Ohms) WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev.
12 • Specifications Table 12.15 – Diathermy Voltage Diathermy Voltage 160 Output Voltage (Volts) +/- 20% 140 120 100 80 60 40 20 0 0 10 20 30 40 50 60 70 80 90 100 Control Panel Settings (%) WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev.
12 • Specifications Phaco Power Graphs Table 12.16 – Longitudinal Phaco Power Phaco Power (Longitudinal) Output Power (Watts) +/- 20% 25 20 15 10 5 0 0 10 20 30 40 50 60 70 80 90 100 Control Panel Settings (%) WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev.
12 • Specifications Table 12.17 – Ellips™ Phaco Power Ellips™ Phaco Power Output Power (Watts) +/- 20% 25 20 15 10 5 0 0 10 20 30 40 50 60 70 80 90 100 Control Panel Settings (%) WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev.
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.
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.
13 ACCESSORIES AND PARTS REORDERING List of Accessories with Part Numbers WHITESTAR SIGNATURE™ System Rx Only – Z370147 Rev.
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.
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 .
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.
13 • Accessories and Parts Reordering System Accessories WHITESTAR SIGNATURE™ System Description Part No.
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.
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.
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.
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.
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.
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.
INDEX A B 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 Ass
Index C 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 Comp
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 E E
Index I 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 G 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 H Handpiece Cleaning 9-2, 9-3 Connecting 3-3 IA 3-18 Phaco 3-20 Priming 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 M 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 Progr
Index P 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
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 R Rear Panel 3-16 Recording Mode 3-28 Reduced/insufficient irrigation fl
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 D
Index U 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 W V Vacuum 5-34 moni
