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. ELLIPS, FUSION, LAMINAR, PHACOFIT, OCCLUSION MODE, and WHITESTAR SIGNATURE are trademarks of Advanced Medical Optics, Inc. DUET and SOLO are trademarks of Micro-Surgical Technology, Inc. The Bluetooth word mark, figure mark (stylized “B Design”), and combination mark (Bluetooth word mark and “B Design”) are registered trademarks of the Bluetooth SIG.
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16 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.
