OPERATOR’S MANUAL
Trademarks AMO, WHITESTAR, ELLIPS, the ELLIPS logo, FUSION, the FUSION logo, LAMINAR, PHACOFIT, CATALYS, and WHITESTAR SIGNATURE are trademarks owned by or licensed to Abbott Laboratories, its subsidiaries or affiliates. DUET and SOLO are trademarks of Micro-Surgical Technology, Inc. BLUETOOTH is a trademark of Bluetooth SIG, Inc. All other brand names, products, and company names mentioned in this document are the trade name, service mark, or trademarks of their respective owners.
TABLE OF CONTENTS Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1 About this Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 About Phacoemulsification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
WHITESTAR SIGNATURE PRO System Table of Contents Surgeon Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1 Select Surgeon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2 Add a New Surgeon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3 Delete Surgeon . . . . . . . . . . . . . . . . . . . . .
WHITESTAR SIGNATURE PRO System Table of Contents Care and Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1 Cleaning and Sterilization Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Phaco Handpiece. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Irrigation/Aspiration Handpiece . . . . . . . . . . . . . . . . . . . . . . .
1 INTRODUCTION About this Manual About Phacoemulsification Intended Use WHITESTAR SIGNATURE PRO System Description and Features WHITESTAR Technology FUSION Fluidics System Accessories WHITESTAR SIGNATURE PRO System Console WHITESTAR SIGNATURE PRO System Operating Modes Safety Precautions Warnings Symbol Definitions System Disposal RX Only – NGP Z370500 Rev.
WHITESTAR SIGNATURE PRO System 1 • Introduction About this Manual This manual includes information about the design of the WHITESTAR SIGNATURE PRO System for anterior segment (phacoemulsification) surgical procedures. This manual includes information about optional system enhancements. Your Abbott Medical Optics Inc. (AMO) representative can confirm the availability of these features for your system configuration and availability in your area. About Phacoemulsification Over thirty years ago, Dr.
WHITESTAR SIGNATURE PRO System 1 • Introduction WHITESTAR ICE Technology The WHITESTAR ICE Technology was the next advance in micropulse phacoemulsification technology. This technology combined modulated ultrasonic power (pulse shaping) with vacuum control through the use of the Chamber Stabilization Environment (CASE). This pulse shaping technology modified the standard “square” wave pulse, by increasing the amplitude of the first millisecond of the on time “kick”.
WHITESTAR SIGNATURE PRO System Accessories 1 • Introduction WHITESTAR Handpiece The design of the phaco handpiece has a straight-through aspiration channel for more efficient removal of nuclear fragments, to minimize clogging and to facilitate cleaning. The handpiece is lightweight, slim, and well-balanced, making it comfortable to use and easy to control. ELLIPS FX Handpiece The ELLIPS FX phaco handpiece is available for use with the WHITESTAR SIGNATURE PRO System.
WHITESTAR SIGNATURE PRO System WHITESTAR SIGNATURE PRO System Console 1 • Introduction Operating room teams contributed significantly to the successful design of the system console. The solid wheel base and locking wheels make the console stable and smooth rolling. An adjustable height Mayo tray accommodates the handpieces and tubing. The remote control is wireless and recharges when attached to the AC Charging Adapter. The foot pedal has an open bin area for storage.
WHITESTAR SIGNATURE PRO System 1 • Introduction MMP – Multiple Mode Programming Multiple submodes are available within the system operating modes. The multiple submodes allows you to preset your settings for specific techniques such as phaco chop or viscoelastic removal. Programmable IV Pole The system has a programmable IV pole. You can set the programmable IV pole height parameters independently for each of the phaco modes plus settings for I/A, and vitrectomy.
WHITESTAR SIGNATURE PRO System 1 • Introduction Irrigation/Aspiration (I/A) The irrigation and aspiration mode allows for controlled aspiration of cortical material from the eye, while maintaining intraocular stability, by replacing the aspirated material with a balanced salt solution. This mode gives you flexible control of each case with the independently adjustable vacuum level settings and flow rate settings. A peristaltic pump provides a predictable and stable aspiration rate.
WHITESTAR SIGNATURE PRO System Safety Precautions 1 • Introduction Once you have set the system up and you have verified that all the functions are operating properly, you are almost ready to use your system. Read the following safety precautions and warnings carefully before you use the system in surgery. 1. Do not use extension cords with your system. 2. Do not overload your electrical receptacle (outlet). 3. If there is damage to the cord or the plug, do not use the instrument.
WHITESTAR SIGNATURE PRO System 1 • Introduction Phacoemulsification without Adequate Irrigation Operating phacoemulsification without an adequate irrigation flow can result in an elevated temperature of the tip and subsequent damage to the eye tissue or could cause the chamber to collapse. Confirm that there is irrigation flow before you initiate phacoemulsification. A tight wound or the angle of the needle next to the wound can also constrict the irrigation flow.
WHITESTAR SIGNATURE PRO System 1 • Introduction Phaco and Vitrectomy Operation Do not activate the phaco handpiece and the vitrectomy cutter with the tips exposed to air, as this reduces the useful life of the handpiece and the cutter.
WHITESTAR SIGNATURE PRO System 1 • Introduction Regulatory Compliance Statements Federal Communications Commission (FCC) Compliance Statement This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) This device must accept any interference received, including interference that may cause undesired operation.
WHITESTAR SIGNATURE PRO System 1 • Introduction WARNING: The surgical staff must monitor the balanced salt solution bottle height and fluid level at all times. A low bottle or empty bottle affects the fluid balance and the intraocular pressure (IOP) while aspirating.
WHITESTAR SIGNATURE PRO System 1 • Introduction WARNING: Place monitoring electrodes or other types of equipment as far from those of the WHITESTAR SIGNATURE PRO System as possible. AMO recommends high current limiting devices for the protection of such systems. Do not use needle monitoring electrodes. WARNING: Keep the diathermy cord away from the patient and other handpieces or leads (for example, monitoring electrodes). Keep unused ACTIVE ELECTRODES away from the patient.
WHITESTAR SIGNATURE PRO System 1 • Introduction WARNING: Not recommended for use in condensing environments. If exposed to a condensing environment, allow the system to equilibrate to typical operating room conditions prior to use. WARNING: You do not need to use a NEUTRAL ELECTRODE with this HIGH FREQUENCY (HF) SURGICAL EQUIPMENT. WARNING: Failure of the HIGH FREQUENCY (HF) SURGICAL EQUIPMENT could result in an unintended increase of output power.
WHITESTAR SIGNATURE PRO System Symbol Definitions 1 • Introduction The following symbols appear on the WHITESTAR SIGNATURE PRO System front and back panels and in the software: Symbol Definition Symbol on the power switch indicates power is on. Symbol on the power switch indicates power is off. Indicates WARNING; a potentially hazardous situation which, if not avoided, could result in serious injury.
WHITESTAR SIGNATURE PRO System Symbol 1 • Introduction Definition Indicates isolation of the patient applied part from earth ground. Foot pedal connection. Communications port Programmable IV pole Diathermy receptacle Phaco handpiece receptacle Vitrectomy cutter receptacle Potential equalizer used to identify the terminals which, when connected together, bring the various parts of an equipment or of a system to the same potential, not necessarily being the earth (ground) potential, e.g.
WHITESTAR SIGNATURE PRO System Symbol 1 • Introduction Definition Indicates the authorized European Union representative. Separate disposal/collection required Indicates manufacturer of the WHITESTAR SIGNATURE PRO System. Date of manufacture of the WHITESTAR SIGNATURE PRO System. Environment friendly use period in years (RoHS) Indicates compliance with IEC 60601-1-2:2001, “Electromagnetic Compatibility Requirements and Tests for Medical Electrical Equipment.
WHITESTAR SIGNATURE PRO System Symbol 1 • Introduction Definition FUSION mode button used to open the CASE and the Occlusion mode settings screen. Single Linear Foot Pedal icon. Shows the current position of the foot pedal as you press the foot pedal. The number changes when the position of the foot pedal changes. When pressed, the Foot Pedal Configuration screen opens. Advanced Control Pedal (ACP) icon. Shows the current position of the foot pedal as you press the foot pedal.
WHITESTAR SIGNATURE PRO System Symbol 1 • Introduction Definition Help - Only active when there is an error. Select this icon to show possible solutions to clear the error. Clear Error - Only active when there is an error. Select this icon after resolving the error. The icon removes the error from the display. Event Log - Select this button on the Configuration screen to view the Event Log.
WHITESTAR SIGNATURE PRO System Symbol 1 • Introduction Definition Set Vacuum Units - Select this button on the Configuration screen to set the vacuum units to either mmHg or kPa. Surgical Media Center (SMC) - Select this button on the Configuration screen to format how the SMC starts to record surgery. Service Interval - Select this button on the Configuration screen to view when the next time maintenance is due on the system.
WHITESTAR SIGNATURE PRO System Symbol 1 • Introduction Definition Move Doctor Name Up - Select a surgeon name on the list of surgeons and use this icon to move the doctor’s name up the list. This can be used to alphabetize the list of surgeons. Move Doctor Name Down - Select a surgeon name on the list of surgeons and use this icon to move the doctor’s name down the list. This can be used to alphabetize the list of surgeons. Settings - Select to set the specific surgical program settings.
WHITESTAR SIGNATURE PRO System System Disposal 1 • Introduction WEEE The electronic components of the WHITESTAR SIGNATURE PRO 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.
WHITESTAR SIGNATURE PRO System Advanced Linear Pedal (ALP) X 1 • Introduction O O O O O Format of this table is in compliance with SJ/T11364-2006 O: Indicates that this toxic/hazardous substance contained in all of the homogeneous materials for this part is below the limit requirement in GB/T26572. X: Indicates that this toxic/hazardous substance contained in at least one of the homogeneous materials used for this part is above the limit requirement in GB/ T26572.
2 SYSTEM COMPONENTS Receipt and Inspection Instructions WHITESTAR SIGNATURE PRO System Components RX Only – NGP Z370500 Rev.
WHITESTAR SIGNATURE PRO System Receipt and Inspection Instructions 2 • System Components When you receive your WHITESTAR SIGNATURE PRO 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 to the exterior packaging, have authorized personnel carefully unpack the WHITESTAR SIGNATURE PRO System and inspect the system for damage.
WHITESTAR SIGNATURE PRO System 2 • System Components Figure 2.1 – WHITESTAR SIGNATURE PRO System 1. Programmable IV Pole 2. FUSION Pack 3. Wireless remote control storage 4. WHITESTAR SIGNATURE PRO System console with Mayo tray 5. Foot pedal storage FUSION Packs Each surgical procedure requires a disposable tubing pack for either the peristaltic pump or the Venturi pump. The FUSION Pack only works with the peristaltic pump used in anterior/cataract surgeries.
WHITESTAR SIGNATURE PRO System 2 • System Components Figure 2.2 – FUSION Tubing Pack 1. To Irrigation Bottle 2. To Handpiece 3. Manifold 4. Drainage Bag Use proper handling and disposal methods for biohazards when you dispose of the tubing pack, Mayo tray drape, and monitor drape.
WHITESTAR SIGNATURE PRO System 2 • System Components Foot Pedal The foot pedal controls all of the system functions, therefore, it is essential that you understand the foot pedal operation. The system software automatically detects if a foot pedal is present and what type of foot pedal is attached during start up. The foot pedal settings and adjustments can be selected and preset for all of the foot pedals on the Foot Pedal Setup screen.
WHITESTAR SIGNATURE PRO System 2 • System Components Figure 2.4 – Advanced Control Pedal 1. Left yaw 2. Wake-up button 3. Left heel switch 5. Right heel switch 5. Right heel switch 6. Lights 7. Right yaw 8. Handle 9. Pedal Figure 2.5 – Advanced Linear Pedal 1. Handle 2. Left and Right Top Switches 3. Left and Right Side Switches 4. Heel rest 5. Pedal RX Only – NGP Z370500 Rev.
WHITESTAR SIGNATURE PRO System 2 • System Components Removing the Handle from the Advanced Linear Pedal 1. To remove the handle, press the clips on either side of the handle. Figure 2.6 – Foot Pedal Handle Diagram Removing the Foot Pedal Handle 2. Remove the cover of the handle. 3. Remove the screws and store the screws and handle in a safe place. Note: Do not lose the handle as it cannot be replaced.
WHITESTAR SIGNATURE PRO System 2 • System Components 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 rocker switch on the side of the console can also be used to control the IV pole. The height is set on the Programmable IV Pole screen. The IV pole moves at a rate of approximately 7.62 cm per second.
WHITESTAR SIGNATURE PRO System 2 • System Components WARNING: DO NOT try to replace the wireless remote control batteries. Call your AMO technical service representative to replace the batteries. Figure 2.9 – 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.
3 SURGERY START UP WHITESTAR SIGNATURE PRO System Setup Front and Rear Panel Connections IV Pole Setup Handpiece Setup Startup Install the FUSION Pack Cup Fill Prime/Tune Verify Irrigation/Aspiration Balance Priming for Vitrectomy Selecting and Changing Mode Parameters System Check-out Pre-operative Sterilization System Shutdown End Case RX Only – NGP Z370500 Rev.
WHITESTAR SIGNATURE PRO System WHITESTAR SIGNATURE PRO System Setup Front and Rear Panel Connections 3 • Surgery Start Up This is a general overview of the steps to take to prepare the WHITESTAR SIGNATURE PRO System for surgery: 1. Attach the power cord to the rear of system. Plug the power cord into a grounded power outlet. 2. Attach the foot pedal to the rear panel receptacle. 3. Attach the compressed air line to the compressed air receptacle (optional). 4.
WHITESTAR SIGNATURE PRO System 3 • Surgery Start Up Figure 3.2 – Rear Panel Connections IV Pole Setup 1. USB port 5. Potential equalizer 2. Communication port 6. Power switch 3. Foot pedal connector 7. Fuse holder 4. Compressed air 8. Power cord connector 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.
WHITESTAR SIGNATURE PRO System Handpiece Setup 3 • Surgery Start Up This section presents information about setting up the handpieces. • Phacoemulsification Handpiece Setup • I/A Handpiece Setup • Diathermy Handpiece Setup • Vitrectomy Handpiece Setup Phacoemulsification Handpiece Setup WARNING: Sterility assurance is the responsibility of the user. You must sterilize all non-sterile accessories prior to use.
WHITESTAR SIGNATURE PRO System 3 • Surgery Start Up Figure 3.4 – ELLIPS FX Handpiece Note: You can use the ELLIPS FX handpiece with WHITESTAR Technology phaco settings. 5. Insert the male luer end of the irrigation tubing into the phaco handpiece. 6. 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 balanced salt solution • sterile handpieces Figure 3.
WHITESTAR SIGNATURE PRO System 3 • Surgery Start Up Irrigation/Aspiration Handpiece Setup Assemble the SOLO Irrigation/Aspiration (I/A) handpiece by attaching the irrigation sleeve. Note: The test chamber is provided in the FUSION Pack. The LAMINAR Flow 20 gauge irrigation sleeves can also be used and are available with the OPOS20L or any 20 gauge LAMINAR phaco tip. Figure 3.6 – I/A Handpiece Assembly 1. Irrigation sleeve 2. Straight tip 3. Handpiece 4. Curved tip 5.
WHITESTAR SIGNATURE PRO System 3 • Surgery Start Up Vitrectomy Cutter Setup If you need to use vitrectomy during surgery: 1. Attach the vitrectomy cutter as shown below. Vitrectomy requires the following components: • I/A Tubing (from FUSION Pack) • Vitrectomy cutter • Vitrectomy irrigation sleeve, or a 23 Gauge Limbal Infusion Needle, if desired. 2. Use the instructions provided with the vitrectomy cutter to assemble the handpiece. Figure 3.9 – Vitrectomy Cutter 3.
WHITESTAR SIGNATURE PRO System Startup 3 • Surgery Start Up After you have turned on the system, the system performs a series of self tests. After start up, the screen shows the available surgeons and programs. Figure 3.
WHITESTAR SIGNATURE PRO System Install the FUSION Pack 3 • Surgery Start Up 1. After you select a surgeon, you must select a program from the surgeon's available programs. Note: The program at the top of the list is the default program for that surgeon. 2. Select the Prime/Tune button. Note: If a pack is needed the Install Pack Screen is shown. Figure 3.11 – Install Pack Screen 3. Install a pack as shown on the screen. RX Only – NGP Z370500 Rev.
WHITESTAR SIGNATURE PRO System Cup Fill 3 • Surgery Start Up To collect the balanced salt solution: 1. Use the test chamber, a medicine cup, or similar container. 2. Press the Prime/Tune button. Figure 3.12 – Prime/Tune Screen with Cup Fill Controls Highlighted 3. Use the up arrow to cycle through the three available amounts of solution to be dispensed.
WHITESTAR SIGNATURE PRO System Prime/Tune 3 • Surgery Start Up You must prime/tune: • before each procedure • anytime you reattach the phaco handpiece • after you have inserted or replaced a tubing pack WARNING: Do not have the handpiece tip in the eye of the patient when you prime and tune the handpiece. The prime/tune process fills the I/A tubing with fluid, performs a vacuum check, and tests and characterizes the phaco handpiece.
WHITESTAR SIGNATURE PRO System 3 • Surgery Start Up Figure 3.13 – Prime and Tune Screen The system tracks the successful completion of the prime and tune cycles independently. If the system needs to be tuned again (new tip, failed tune), you only need to select and run the tune. CAUTION: DO NOT ACTIVATE THE PHACO HANDPIECE AND VITRECTOMY CUTTER WITH THE TIP IN THE AIR. EXPOSURE OF THE TIP TO AIR DRASTICALLY REDUCES THE USEFUL LIFE OF THE HANDPIECE.
WHITESTAR SIGNATURE PRO System 3 • Surgery Start Up Suggestions for Priming the Handpieces Do not lay the handpiece and the empty test chamber down and have the system fill the test chamber. When you lay down the handpiece, this allows air to collect in the test chamber and can produce an error. Point the tip of the handpiece up to reduce the amount of bubbles. 1. Use Continuous Irrigation to fill the tubing with fluid. Remember to hold the ends of the tubing over a container to catch any fluid. 2.
WHITESTAR SIGNATURE PRO System Verify Irrigation/ Aspiration Balance 3 • Surgery Start Up We strongly recommend you verify that you balanced Irrigation/Aspiration properly for your settings used in surgery. Figure 3.14 – Irrigation/Aspiration Balance Procedure To verify irrigation/aspiration balance: 1. In Phaco 1 mode, hold the handpiece at the approximate patient eye level. Note: The numbers in the drawing Figure 3.14 correspond to the steps listed. 2.
WHITESTAR SIGNATURE PRO System Priming for Vitrectomy 3 • Surgery Start Up Before you perform vitrectomy, we recommend you prime the handpiece to reduce the chance of errors. Each time you select vitrectomy mode, a dialog box asks you 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 tubing and the aspiration tubing of the pack together. Press Prime on the Prime/Tune screen. Press the VIT button to access VIT mode.
WHITESTAR SIGNATURE PRO System Selecting and Changing Mode Parameters 3 • Surgery Start Up The design of the system's graphical user interface (GUI) and touch screen is for ease-of-use, consistent look, and maximum informational display during all operating modes. Your interface with the system requires only three basic steps, which apply to all the selections, settings and operations.
WHITESTAR SIGNATURE PRO System 3 • Surgery Start Up Figure 3.17 – Phaco Submode Settings Screen System Check-out The purpose of the check-out procedure is to verify that installation of the system is complete and the system is operating properly. You must perform the check-out procedure prior to the first case of the day, as outlined in the following steps. You test the I/A mode and handpiece, then the phaco mode and handpiece, so that the phaco handpiece (used first) is ready for surgery.
WHITESTAR SIGNATURE PRO System 3 • Surgery Start Up Phacoemulsification Follow these steps to check the system out for phacoemulsification. 1. Attach the tubing to the phaco handpiece. 2. Screw the phaco needle onto the handpiece, use your fingers to engage the screw thread, and then use the tip wrench to tighten the needle. 3. Screw the irrigation sleeve over the needle. 4. Place the test chamber over the irrigation sleeve. 5. Prime and Tune the system. 6. Select the phaco mode. 7.
WHITESTAR SIGNATURE PRO System 3 • Surgery Start Up Diathermy Follow these steps to check the system out for diathermy. 1. Attach the diathermy forceps to the cable and the cable to the front panel of the console. 2. Select the Diathermy mode. 3. Press the foot pedal. You should hear a tone when you press the foot pedal. CAUTION: IF YOU DO NOT HEAR A TONE WHEN YOU PRESS THE FOOT PEDAL AND VOLUME ADJUSTMENT IS UNSUCCESSFUL, THE MODE IS NOT FUNCTIONING PROPERLY.
WHITESTAR SIGNATURE PRO System 3 • Surgery Start Up Pre-operative Sterilization Prior to each surgical case, sterilize the system instruments with the recommended sterilization techniques, times and temperatures given in Chapter 7, “Care and Cleaning”. AMO recommends that you follow the sterilization guidelines to maximize the life of your system instruments. System Shutdown The following is a general overview of the steps to be taken to shut the system down after surgery: 1. 2. 3. 4. 5. 6.
WHITESTAR SIGNATURE PRO System End Case 3 • Surgery Start Up End Case is available in the top panel from any programming or surgical mode. End Case allows you to terminate the programming session or surgical case. Figure 3.18 – End Case Screen Note: For ease of viewing, the EPT, EFX, UST, and DT times are in a large font size on the End Case screen. The EFX shows only when you attach an ELLIPS FX handpiece.
WHITESTAR SIGNATURE PRO System 3 • Surgery Start Up Continue Case – Select Continue Case to return to the current case, after you selected Review Case. Purge – Select Purge to remove the fluid from the irrigation and aspiration tubing before you remove the pack. Shutdown – Select the Shutdown button to turn the system off. At the prompt, press Yes to complete the process. Next Case If any changes were made to the settings, you are prompted to confirm and save the changes. Figure 3.
