Abbott Medical Optics SOVEREIGN Signature Operators Manual Rev B

WHITESTAR SIGNATURE OPERATOR’S MANUAL

RX Only – NGP Z370338 Rev.B 1011

Trademarks

AMO, WHITESTAR, SOVEREIGN, DIPLOMAX, ELLIPS, the ELLIPS logo, FUSION, the FUSION logo, LAMINAR, PHACOFIT, 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.

Compliance

In accordance with IEC/EN 60601-1 Abbott Medical Optics Inc. 1700 E. St. Andrew Place  Santa Ana, CA, USA 92705  1-877-AMO-4-LIFE (USA) www.abbottmedicaloptics.com Product of USA AMO Ireland Block B  Liffey Valley Office Campus

Quarryvale, Co. Dublin, Ireland Order Surgical Products

IOLs and Phaco Supplies Call 1-877-AMO-4-LIFE (USA)  For outside the United States: 1-800-511-0911.

Returns or Technical Service

Call 1-877-AMO-4-LIFE (USA) All returns must be accompanied by a RGA# (Returned Goods Authorization) For outside the United States: 1-800-511-0911. Rx Only © 2011 Abbott Medical Optics Inc.

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TABLE OF CONTENTS Introduction... 1-1 About this Manual... 1-2 About Phacoemulsification... 1-2 Intended Use... 1-2 WHITESTAR SIGNATURE System Description and Features... 1-2 WHITESTAR Technology... 1-3 FUSION Fluidics System... 1-3 Accessories... 1-4 WHITESTAR SIGNATURE System Console... 1-5 WHITESTAR SIGNATURE System Operating Modes... 1-6 Safety Precautions... 1-7 Warnings... 1-11 Symbol Definitions... 1-13 System Disposal... 1-16

System Components... 2-1 Receipt and Inspection Instructions... 2-2 WHITESTAR SIGNATURE System Components... 2-2

System Setup... 3-1 WHITESTAR SIGNATURE System Setup... 3-2 Front and Rear Panel Connections... 3-3 FUSION Tubing Pack Setup... 3-4 IV Pole Setup... 3-5 Handpiece Setup... 3-8 Foot Pedal Setup... 3-12 Wireless Remote Control Setup and Testing... 3-34 Calibrate Touch Screen... 3-35 Set Units of Measure for Vacuum... 3-36 Set and Test System Sound Levels... 3-37 Set the System Date and Time... 3-39 Feature Installation (Optional)... 3-40 Surgical Media Center (SMC) (Optional)... 3-42 Add a Custom Logo Screen... 3-43 System Check-out... 3-44 Pre-operative Sterilization... 3-46 System Shutdown... 3-46

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Table of Contents

Equipment Operation... 4-1 Display Screens and Controls... 4-2 Language Selection... 4-3 Startup... 4-5 Select Program and Install the FUSION Tubing Pack... 4-6 Cup Fill... 4-8 Prime/Tune... 4-9 Verify Irrigation/Aspiration Balance... 4-12 Priming for Vitrectomy... 4-13 Selecting and Changing Mode Parameters... 4-14

Anterior Segment Surgery Operating Modes... 5-1 Programming the Modes and Settings... 5-2 Phacoemulsification... 5-4 ELLIPS Technology... 5-27 Diathermy... 5-28 Irrigation/Aspiration... 5-31 Vitrectomy... 5-34 Continuous Irrigation... 5-38 Aspiration Flow Rate... 5-39 Vacuum... 5-39 Passive Reflux... 5-40 End Case... 5-41

Surgeon Programs... 6-1 Select Surgeon/Program... 6-2 Add a New Surgeon... 6-3 Edit a Surgeon... 6-5 Select a Preferred Program... 6-6 Create a New Program... 6-7 Edit a Surgeon Program... 6-8 Copy a Surgeon Program... 6-9 Delete a Surgeon... 6-9 Delete a Program... 6-10 Delete a Database... 6-10 Restore a Database... 6-11 Lock a Program... 6-12 Program – Assign Order... 6-13

Diagnostics... 7-1 Diagnostics... 7-2

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Care and Cleaning... 8-1 Cleaning Procedures... 8-2 Sterilization Procedures... 8-3 WHITESTAR SIGNATURE System Cleaning and Care... 8-5

Error Messages Troubleshooting and Diagnostics... 9-1 Most Common User-Correctable Problems... 9-2 Fuse Replacement Procedure... 9-2 Troubleshooting... 9-3 General... 9-3 Irrigation... 9-5 Aspiration... 9-6 Phacoemulsification... 9-7 Diathermy... 9-8 Vitrectomy... 9-8 Status, Warning and Error Messages... 9-9 Error Messages... 9-10

Warranty and Maintenance... 10-1 Warranty Statement... 10-2

Specifications... 11-1 Physical Specifications... 11-2 Environmental Specifications... 11-3 Electrical Specifications... 11-3 Phacoemulsification Specifications... 11-3 Irrigation and Aspiration Specifications... 11-3 Vitrectomy Specifications... 11-3 Diathermy Specifications... 11-4 Diathermy Power Graphs... 11-4 Diathermy Power versus Load Impedance... 11-9 Phaco Power Graphs... 11-12

Accessories and Parts Reordering... 12-1 List of Accessories with Part Numbers... 12-2

Glossary... 13-1 Index... 14-1

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1

INTRODUCTION

About this Manual About Phacoemulsification Intended Use WHITESTAR SIGNATURE System Description and Features WHITESTAR Technology FUSION Fluidics System Accessories WHITESTAR SIGNATURE System Console WHITESTAR SIGNATURE System Operating Modes Safety Precautions Warnings Symbol Definitions System Disposal

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About this Manual

1 • Introduction

This manual includes information about the design of WHITESTAR SIGNATURE System for anterior segment (phacoemulsification) surgical procedures. This manual includes information about optional system enhancements. Your 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. Charles Kelman conceived and developed phacoemulsification (phaco), a method of cataract removal by use of ultrasonic emulsification with aspiration of the cataractous lens through a small incision. Phacoemulsification is advantageous for both patient and surgeon: • Greater intraoperative control. • The smaller incision requires fewer or no sutures, poses less risk of infection and induced astigmatism, and gives better long-term and short-term predictability of vision. • Patients are able to resume normal activity much sooner and with fewer restrictions than with traditional cataract extraction surgeries. AMO supports phacoemulsification with sophisticated instrumentation that optimizes the benefits of this surgical procedure.

Intended Use

The WHITESTAR SIGNATURE System is a modular ophthalmic microsurgical system that facilitates anterior segment (cataract) surgery. The modular design allows the users to configure the system to meet their surgical requirements. You do not need a specified neutral electrode with this high frequency (HF) surgical equipment.

WHITESTAR SIGNATURE System Description and Features

The WHITESTAR SIGNATURE System is a multifunctional tool for use in anterior segment surgery procedures. The WHITESTAR SIGNATURE System represents the latest generation of AMO phacoemulsification technology. Designed and manufactured into every WHITESTAR SIGNATURE System are safety, ease-of-use, and reliability. The WHITESTAR SIGNATURE System meets applicable United States and International safety requirements for this type of device. The WHITESTAR SIGNATURE System contains a number of features based on extensive research and clinical trials with highly trained and noted ophthalmologists with experience as phacoemulsification surgeons.

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WHITESTAR Technology

1 • Introduction

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 system to achieve full ultrasound cutting efficiency and magnetic followability, while introducing less energy into the eye. Minimized or eliminated ultrasonic time reduces the risk of thermal damage.

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”. The technology then set the remaining part of the on time to the standard power setting. This process repeats for each on time pulse. This results in increased control and efficiency in phacoemulsification.

Occlusion Mode Phaco The Occlusion mode phaco regulates the vacuum rise time following an occlusion of the phaco tip, without limiting the choice of aspiration rate through an unoccluded needle. To independently control the aspiration rate and the vacuum rise time, you can have a different aspiration rate when the needle occludes than when the needle is unoccluded. The Occlusion mode phaco also regulates the ultrasound power modulation. You can program the power modulation of the phaco handpiece (continuous, pulse, burst) to automatically change when the phaco tip changes from an unoccluded condition to an occluded condition. The FUSION mode allows the user to access the settings and variables for both CASE and Occlusion mode phaco. The CASE and Occlusion mode phaco can work together or independently.

FUSION Fluidics System

The system has both a flow-based peristaltic pump system and a vacuum based Venturi pump system. The patented microprocessor-based system continuously monitors and controls intraocular conditions of the flow and vacuum in the eye.

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1 • Introduction

Chamber Stabilization Environment (CASE) CASE is an intelligent vacuum monitoring system that regulates the maximum allowable vacuum used following the occlusion of the phaco tip. When the phaco tip becomes occluded, the vacuum rises. Clearing of the occlusion while the vacuum is at a high-level can lead to a post occlusion surge. When CASE is on, the system monitors the actual vacuum levels. When the vacuum exceeds a specific threshold for a specified duration, the system automatically adjusts the maximum allowable vacuum setting to a lower predefined CASE maximum vacuum level. When the occlusion clears, the system automatically restores the settings to the original programmed maximum vacuum setting. This function makes it possible to have a different maximum vacuum setting when the needle occludes than when the needle is unoccluded.

Accessories

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 System. The ELLIPS FX handpiece provides both longitudinal and transversal movement. You can use the handpiece with a straight tip or a curved tip.

Foot Pedal The foot pedal controls the various operating modes of the instrument. You can program the foot pedal settings through the user interface. You can use either the standard foot pedal or the Advanced Control Pedal with the system. The foot pedal design offers control through the use of increased linearity with the foot pedal movement. The design provides uniform pressure throughout the foot pedal movement, easing foot, and leg fatigue. You can select the degrees of movement for each foot pedal position. You can save the settings for each surgeon/ mode, pitch for the standard foot pedal only and pitch and yaw for the Advanced Control Pedal giving the pedal dual linear functionality. Programmable switches can activate reflux, giving an immediate response.

Wireless Remote Control The surgery can be controlled from the wireless remote control keypad. You can access all surgical modes and adjust all surgical settings with the use of the wireless remote control. Backlighting supports low light operating room conditions.

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WHITESTAR SIGNATURE 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 placed in remote control storage bay. The foot pedal has an open bin area for storage.

WHITESTAR SIGNATURE System Display (Graphic User Interface-GUI) The system graphic screen display is easy to read and easy to operate. You can see at a glance the status of the system. The screen gives you visual indication of operating modes, settings, and system status. Messages cue you through the procedure, and error messages indicate improper connections, or selections. Help information is available from the touch screen controls.

Prime/Tune Before the start of each surgical case, the system requires that you run prime, tune or prime/tune. The prime mode incorporates the function of clearing the tubing of fluid. The prime mode then fills the tubing and completes the fluid aspiration check and the vacuum check. The tune mode incorporates an ultrasonic power calibration check and safety check for the attached phaco handpiece. The prime/tune mode allows the system to prime and tune the handpiece at the same time.

Dual Pump The system provides a fluid aspiration system that uses either a peristaltic (flow-based) pump or a Venturi (vacuum-based) pump system. The surgeon can use the Venturi pump in the phaco, IA, and vitrectomy surgical modes.

Continuous Irrigation Continuous Irrigation is immediately available by way of the touch screen. Surgeon control of continuous irrigation with the foot pedal is also available. You can use continuous irrigation to fill cups prior to prime/tune. You can use the cup fill feature in place of continuous irrigation when you fill a cup. The cup fill feature is only available from the prime/tune screen. (See Prime/Tune in for detailed information.)

Programmable Operating Parameters The 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. The instrument program memory stores up to 50 surgeon names with a maximum of 20 different setups, plus the AMO default settings program. This allows different users to preset their preferences, or an individual user to select setups for different procedures, including a personalized initial operating mode.

MMP – Multiple Mode Programming Multiple submodes are available within the system operating modes. The multiple submodes allows you to preset your settings for specific techniques such as phaco chop or viscoelastic removal.

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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 diathermy, IA, and vitrectomy. During surgery, the programmable IV pole height changes to the preprogrammed height when you switch modes. The automated and programmable IV pole allows adjustment of the bottle height to provide gravity infusion through each procedural phase. Two up and down arrows on the touch screen or the wireless remote control raises and lowers the bottled balanced salt solution, while maintaining the sterility of the operating field. A separate up and down switch allows IV pole adjustment from the side of the system.

Internet Connectivity Internet Connectivity will allow AMO service representatives to read and analyze critical system parameters, which can minimize the frequency and duration of down time.

WHITESTAR SIGNATURE System Operating Modes

The design of the system provides all the operating modes and surgical capabilities that the anterior segment surgeon or the cataract surgeon requires. These capabilities include: Phacoemulsification (Phaco) You use the phacoemulsification mode to break up (emulsify) the nucleus of the lens. You then aspirate the nucleus of the lens 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. The system displays phaco time in minutes and seconds. The convenient selection of linear or panel preset phaco power, in a variety of power delivery options (pulsed, burst, transversal), provides increased precision, and control. The WHITESTAR Technology allows you to safely remove all lens types through small incisions with single-mode, single-instrument convenience. The WHITESTAR Technology is a patented software program proven to change the characteristics of phacoemulsification using little or no ultrasound. The WHITESTAR Technology changes the thermal properties and improves control of the lens without reducing the cutting power or changing technique or efficiency.

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1 • Introduction

Irrigation/Aspiration (IA) The irrigation and aspiration mode allows for controlled aspiration of cortical material from the eye, while maintaining intraocular stability, by replacing the aspirated material with a balanced salt solution. A peristaltic pump provides a predictable and stable aspiration rate. “Aspiration Rate” and “Vacuum” settings allows for complete control. Irrigation is gravity-fed. Note:

The vacuum units can be set to either mmHg or kPa. To set the vacuum units go to Configuration, System Configuration, Set Vacuum Units.

You can regulate the gravity-fed irrigation by adjusting the height of the balanced salt solution bottle. This mode gives you flexible control of each case with the independently adjustable vacuum level settings and flow rate settings. Vitrectomy (VIT) You use the Vitrectomy mode to remove vitreous from the eye during surgery. The system uses air pressure to drive the vitreous cutter. The wide range of user-controlled, programmable cut rates supports both anterior segment and posterior segment surgeries.

Diathermy (DIA) Most surgeons use the diathermy mode to coagulate blood vessels during the procedure and by some surgeons to “coag” the conjunctiva at the end of the procedure. An isolated output frequency allows noncontact tissue coagulation, eliminating adhesion, and traction. Also, the depth of penetration of the energy field is less than that of lower frequency units, which minimizes tissue shrinkage or charring. The gentleness of the diathermy mode allows the surgeon to stop “bleeders” within the incision with only minimal scleral shrinkage. CASE One Touch The One Touch button simplifies the programming of the CASE function and allows you to easily define the basic CASE settings once. You can adjust the CASE function with the CASE One Touch settings on the surgical screens. When you use these controls, the CASE functionality changes to provide enhanced control or improved efficiency to suit any particular combination of cataract density, surgical technique or personal preferences.

Safety Precautions

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. The system comes equipped with 3-prong power plug which you must plug into an outlet with a ground receptacle. If the plug does not fit the outlet, contact an electrician. DO NOT modify or remove the ground pin. 2. Do not use extension cords with your system. 3. Do not overload your electrical receptacle (outlet).

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1 • Introduction

4. If there is damage to the cord or the plug, do not use the instrument. A damaged cable can cause an electric shock to the user or a fire hazard to the system. Call AMO customer service to order a new cord. 5. The instrument has ventilation openings at the rear of the console to allow ambient air intake and the release of heat generated during operation. Do not block the openings; as heat build-up can cause system failures which can result in a fire hazard. 6. Do not try to move the system cart on deep pile carpets or over objects on the floor such as cables and power cords. 7. Take care not to trip over power and foot pedal cords. 8. Do not try to lift the system console. 9. Do not place the instrument on uneven or sloped surfaces. 10. Only use disposables, accessories, or other surgical instruments designed for this system. For optimum performance of the system and safety, use only parts recommended by AMO. 11. Do not operate the system in a condensing environment. Take care to protect the instrument from fluid sprays or fluid buildup. 12. To protect the patient from contaminated fluids or handpieces, use only: • sterile tubing packs • sterile irrigation fluid • sterile handpieces 13. Wrap the excess power cord neatly around the cord wrap on the back of the console. 14. Use caution when you extend, retract, or swivel the Mayo stand articulating arm. Stay clear of the hinged hardware. 15. Use caution when you use handpieces with sharp edges or pointed tips. 16. Always replace the tubing pack between cases.

Changing Irrigation Flow Use extreme caution when you lower or raise the balanced salt solution bottle to decrease fluid flow or increase fluid flow, and fluid pressure. If you lower the bottle too much it can cause the anterior chamber to collapse. If you raise the bottle too high it can cause the anterior chamber to deepen. To make sure that the bottle height does not go too high, you can set the maximum bottle height on the Diagnostics screen. Use extreme caution when you lower or raise the balanced salt solution bottle to decrease fluid flow or increase fluid flow, and fluid pressure. If you lower the bottle too much it can cause the anterior chamber to collapse or to become too shallow; care should be taken to avoid abrasion of tissues during phacoemulsification. If you raise the bottle too high it can cause the anterior chamber to deepen. To make sure that the bottle height does not go too high, you can set the maximum bottle height on the Diagnostics screen. Note:

Use a new bottle of balanced salt solution at the start of each case.

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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. Pinching the coaxial irrigation sleeve assembly on the needle of the phaco handpiece causes the constriction.

Power Failure during Surgery If there is a loss of power during a procedure, you need to: • Withdraw the handpiece from the eye • Release the foot pedal to position 0 When power is restored: • Select Prime/Tune to reprime the fluids and tune the phaco handpiece. Use Bypass to reduce the length of prime time. • Select the mode that was in use when the system lost power (Phaco, IA, Vitrectomy, or Diathermy)

Attaching Handpieces It is very important that the electrical connectors on the handpieces are completely dry before you attach the handpiece to the system receptacles. You can receive a “Handpiece Ground Fault Error” message if the connector is wet.

Handling the Phaco Handpiece The phaco handpiece is a very delicate instrument and you must handle the handpiece with EXTREME care. If you drop the handpiece or the handpiece receives any other significant impact, the handpiece will not work properly. The ultrasonic titanium phaco tip must never touch any solid material while in use. Always clear the handpiece of fluid immediately following surgery. See cleaning instructions in Chapter 8, “Care and Cleaning”. Handpieces can be extremely hot immediately after sterilization. Use care and caution when handling.

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. When you introduce power to the phaco handpiece or the vitrectomy cutter, the tips must be in a test chamber filled with a balanced salt solution, in a container of balanced salt solution, or in the patient's eye.

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1 • Introduction

Vitrectomy Failure to properly attach the tubing to the appropriate vacuum source or pressure source can affect the vitrectomy cutter operation. Be sure to read the vitrectomy cutter package insert for the correct assembly procedures and connection procedures.

Diathermy When you select the Diathermy mode, you hear an audible tone. Also, you will hear an audible tone when you apply diathermy power. You must check the diathermy cable periodically for damage. If the cable shows signs of damage, replace the cable immediately with the same type of cable. Use of other types of cables can affect the diathermy performance. During surgery, the diathermy output power must be as low as possible for the intended purpose. AMO recommends the 30% setting to start. You must position the diathermy cable in such a way that the cable avoids contact with the patient or other leads. When you use diathermy, grounded or ungrounded metal parts must not come in contact with the patient. For proper operation of the diathermy, replace the handpiece with the same type.

Programmable IV Pole Do not exceed the maximum weight of two 500 ml balanced salt solution bottles on the IV pole bottle holder.

Wireless Remote Control, Wireless Foot Pedal, and Battery Management System This device complies with Part 15.19 of the FCC (Federal Communications Commission) Rules. Operation is subject to the following two conditions: • This device may not cause harmful interference. • This device must accept any interference received, including interference that may cause undesired operation. Any changes or modifications not expressly approved by AMO can void the user's authority to operate the equipment. (FCC Part 15.21) Note:

This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to Part 15.105 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense.

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1 • Introduction

Warnings WARNING: All personnel who might operate this equipment must read and understand the instructions in this manual before they use the system. Failure to do so might result in the improper operation of the system. Only a trained licensed physician can use this device. 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. Low bottle height or low or empty bottle fluid level can result in: • Inadvertent chamber shallowing or collapse • Aspiration or abrasion of the iris or other tissue • An ultrasonic wound heating commonly called wound burn (extreme case) WARNING: DO NOT attempt to use the system if the system fails to perform properly as stated in this manual. WARNING: DO NOT use the system in the presence of any of the following as a fire can result: • flammable anesthetics • other flammable gases • flammable fluids • flammable objects • oxidizing agents WARNING: Make sure that the patient does not have a cardiac pacemaker as this unit might interfere with any cardiac pacemaker; therefore obtain qualified advice prior to such use. WARNING: The patient must not come into contact with grounded metal parts or metal parts that have appreciable capacitance to ground. AMO recommends the use of an antistatic mat for this purpose. WARNING: Use proper handling and disposal methods for biohazards when you dispose of the tubing pack, mayo stand drape, and monitor drape. WARNING: Place monitoring electrodes or other types of equipment as far from those of the WHITESTAR SIGNATURE System as possible. AMO recommends high current limiting devices for the protection of such systems. Do not use needle monitoring electrodes.

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1 • Introduction WARNING: Keep the diathermy cord away from the patient and other handpieces or leads (for example, monitoring electrodes). WARNING: The output power selected must be as low as possible for the intended purpose. WARNING: This unit complies with all Electromagnetic Interference (EMI) standards and requirements. It is possible that interference provided by the operation of the HIGH FREQUENCY (HF) SURGICAL EQUIPMENT can adversely influence the operation of other electronic equipment. WARNING: Do not have skin-to-skin contact on the patient. For example, between the arms and the torso. Insert dry gauze to avoid contact, as appropriate. Note: The unit does not contain any neutral electrode. Note:

The diathermy output is bipolar.

Note:

AMO recommends that you check the condition of all interconnecting and handpiece cables on a regular basis.

WARNING: Risk of burns and fire. Do not use the system near conductive materials such as metal bed parts, inner spring mattresses, or similar items. Replace electrode cables on evidence of deterioration. WARNING: Hazardous electrical output. This equipment is for use only by qualified personnel. WARNING: Disconnect the power before you service the equipment. WARNING: Remove the power cord from the power outlet when the equipment is not in use. WARNING: Do not obstruct the power outlet so you can readily remove the power cord. 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.

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1 • Introduction 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. You must sterilize all non-sterile accessories prior to use. WARNING: Prior to using any invasive portions of the handpiece assembly, examine under the microscope for any obvious damage, oxidation, or the presence of foreign material. You must note any questionable characteristics; use a backup handpiece for surgery. Use of contaminated or damaged system accessories can cause patient injury. WARNING: Do not use non-AMO approved products with the WHITESTAR SIGNATURE System, as this can affect overall system performance. AMO cannot be responsible for system surgical performance if you use these products in surgery.

Symbol Definitions

The following symbols appear on the WHITESTAR SIGNATURE System front and back panels and in the software: Table 1.1 – Symbol Definitions Symbol

Definition Symbol on the power switch indicates power is on.

Symbol on the power switch indicates power is off.

Indicates there is a possible danger to the user. In the manual, the symbol indicates information the user must read. Indicates that there are important operating and maintenance instructions included in the operator’s manual. Indicates the presence of uninsulated high voltage inside the instrument. Risk of electric shock. Do not remove the instrument cover. Indicates fuse.

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Symbol

Definition Single phase alternating current. Indicates isolation of the patient applied part from earth ground. Indicates grounding of the patient applied part OR no involvement of direct electrical energy. Foot pedal connection. Communications port

Programmable IV pole Diathermy receptacle Phaco handpiece receptacle Vitrectomy cutter receptacle Potential equalizer

Indicates compliance with the Medical Device Directive.

Indicates the authorized European Union representative. Separate disposal/collection required

Indicates manufacturer of the WHITESTAR SIGNATURE 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.”

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