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WHITESTAR SIGNATURE™ System

Rx Only – Z370147 Rev. C 1008

2-1

Receipt and Inspection Instructions

WHITESTAR SIGNATURE™ System Components

WHITESTAR SIGNATURE™ System with FUSION™ Tubing Pack

SYSTEM COMPONENTS

Summary of Contents for SIGNATURE

Page 1: ...acement of Surgical Products IOLs and Phaco Supplies Call 1 877 AMO 4LIFE USA 1 877 266 4543 For Phaco Returns or Technical Service Call 1 877 AMO 4LIFE USA 1 877 266 4543 All returns must be accompanied by a RGA Returned Goods Authorization EC REP AMO Ireland Block B Liffey Valley Office Campus Quarryvale Co Dublin Ireland Rx Only Z370147 Rev C 1008 2008 Advanced Medical Optics Inc ...

Page 2: ...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 All brand names and products and company names mentioned in this document are the trade name service mark or registered trademarks of their respective owners Compliance In accordance with ...

Page 3: ...E System Components 2 2 WHITESTAR SIGNATURE System with FUSION Tubing Pack 2 4 System Setup 3 1 Safety Precautions 3 2 Warnings 3 5 Symbol Definitions 3 9 System Disposal 3 12 Setup Sequence Anterior Segment Surgery 3 15 Footpedal 3 22 Programmable IV Pole 3 25 Wireless Remote Control Optional 3 26 Surgical Media Center SMC Optional 3 28 Shutdown Sequence Anterior Segment Surgery 3 30 Equipment Op...

Page 4: ...d a New Surgeon 6 3 Edit a Surgeon 6 5 Select a Preferred Program 6 6 Create a New Program 6 8 Edit a Surgeon Program 6 9 Copy a Surgeon Program 6 10 Delete a Surgeon 6 11 Delete a Program 6 12 Delete a Database 6 13 Lock a Program 6 13 Program Assign Order 6 14 Diagnostics 7 1 Diagnostics 7 2 Wireless Footpedal Setup 7 3 Wireless Foot Pedal Calibration 7 5 Wireless Remote Control Setup 7 6 Calibr...

Page 5: ...s 10 5 Troubleshooting 10 16 Warranty and Maintenance 11 1 Warranty Statement 11 2 Specifications 12 1 Physical Specifications 12 2 Environmental Specifications 12 3 Electrical Specifications 12 3 Diathermy Specifications 12 3 Irrigation and Aspiration Specifications 12 3 Phacoemulsification Specifications 12 4 Vitrectomy Specifications 12 4 Diathermy Power Graphs 12 5 Diathermy Power versus Load ...

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Page 7: ... 1 About this Manual About Phacoemulsification Intended Use WHITESTAR SIGNATURE System Description Features WHITESTAR Technology FUSION Fluidics System Accessories WHITESTAR SIGNATURE System Console WHITESTAR SIGNATURE System Operating Modes 1 INTRODUCTION ...

Page 8: ...ictions than with traditional cataract extraction surgeries Advanced Medical Optics Inc AMO supports phacoemulsification with sophisticated instrumentation that optimizes the benefits of this surgical procedure Intended Use The WHITESTAR SIGNATURE System is a modular ophthalmic microsurgical system that facilitates anterior segment cataract surgery The modular design allows the users to configure ...

Page 9: ...re wave pulse by increasing the amplitude of the first millisecond of the On Time kick and then setting the remaining part of the On Time to the standard power setting This is repeated for each On Time period resulting in increased control and efficiency in phacoemulsification OCCLUSION MODE Phaco The OCCLUSION MODE Phaco is used to regulate the vacuum rise time experiences following occlusion of ...

Page 10: ...ndpiece The Phaco Handpiece has been designed with a straight through aspiration channel for more efficient removal of nuclear fragments to minimize clogging and to facilitate cleaning The hand piece is lightweight slim and well balanced making it comfortable to use and easy to manipulate Ellips Handpiece An Ellips phaco handpiece is available for use with the WHITESTAR SIGNATURE System The Ellips...

Page 11: ...m status Messages cue you through the procedure and error messages indicate improper connections or selections Help information is available from the touch screen controls Prime Tune Before the start of each surgical case the system requires Prime Tune or Prime Tune to be executed The Prime mode incorporates the function of tubing purge and fills and completes the fluid aspiration and vacuum check...

Page 12: ...ery the programmable IV pole height changes to the preprogrammed height when you switch modes The automated and programmable IV pole allows adjustment of the bottle height to provide gravity infusion through each procedural phase Two adjustment keys on the touch screen or the wireless remote control are used to raise and lower the bottled balanced salt solution while maintaining the sterility of t...

Page 13: ...mplifies the programming of the CASE function and allows you to easily define the basic CASE settings once The CASE function can then be adjusted quickly with the CASE One Touch settings on the surgical screens When these controls are used the CASE functionality can be changed to provide enhanced control or improved efficiency to suit any particular combination of cataract density surgical techniq...

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Page 15: ...WHITESTAR SIGNATURE System Rx Only Z370147 Rev C 1008 2 1 Receipt and Inspection Instructions WHITESTAR SIGNATURE System Components WHITESTAR SIGNATURE System with FUSION Tubing Pack 2 SYSTEM COMPONENTS ...

Page 16: ...e contacted you to schedule both the Installation and the In Service Training when you receive your new WHITESTAR SIGNATURE System We suggest that you leave the WHITESTAR SIGNATURE System in the original packaging and store the package in a cool dry environment until the AMO installation personnel arrive to assemble install and test your equipment Extreme heat cold or moisture can damage any elect...

Page 17: ... Rev C 1008 2 3 Figure 2 1 WHITESTAR SIGNATURE System 1 Programmable IV Pole 4 WHITESTAR SIGNATURETM System console with Integral Cart and Mayo Tray 2 FUSIONTM Tubing Cassette 3 Wireless Remote Control Module Storage bay on top of the system 5 Footpedal 1 2 3 4 5 ...

Page 18: ... pump and the Venturi pump With the Fusion Dual Pump Pack you can select either pump while you are in a surgical case The tubing pack contains the following components Tubing cassette with irrigation and aspiration tubing administration set with an attached sealed drain bag Infusion Sleeve Test Chamber to test and prime tune the phaco handpiece Mayo Stand Drape to cover the Mayo tray and arm Monit...

Page 19: ...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 3 SYSTEM SETUP ...

Page 20: ... air intake and the release of heat generated during operation If the openings are blocked heat build up can cause system failures which can result in a fire hazard 6 Do not try to move the WHITESTAR SIGNATURE System cart on deep pile carpets or over objects on the floor such as cables and power cords 7 Take care not to trip over power and footpedal cords 8 Do not try to lift the WHITESTAR SIGNATU...

Page 21: ...phacoemulsification A tight wound or the angle of the needle next to the wound can also constrict the irrigation flow by pinching the coaxial irrigation sleeve assembly on the needle of the phaco handpiece Power Failure during Surgery If there is a loss of power during a procedure you need to Withdraw the handpiece from the eye Release the footpedal to Position 0 When power is restored Select Prim...

Page 22: ...heard The diathermy cable must be checked periodically for damage If the cable shows signs of damage replace the cable immediately with the same type of cable Use of other types of cables can affect the diathermy performance During surgery the diathermy output power must be as low as possible for the intended purpose AMO recommends the 30 setting to start The diathermy cable must be positioned in ...

Page 23: ...ipment must read and understand the instructions in this manual before the system is used Failure to do so might result in the improper operation of the system This device is only to be used by a trained licensed physician WARNING The fluid level in the balanced salt solution bottle must be monitored by the surgical nursing staff The result of a low bottle or an empty bottle affects the fluid bala...

Page 24: ...ape WARNING Monitoring electrodes or other types of equipment must be placed as far from those of the WHITESTAR SIGNATURE System as possible High current limiting devices are recommended for the protection of such systems Needle monitoring electrodes are not recommended WARNING Keep the diathermy cord away from the patient and other handpieces or leads for example monitoring electrodes WARNING The...

Page 25: ... 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 WA...

Page 26: ...is the responsibility of the user All non sterile accessories must be sterilized prior to use WARNING Prior to using any invasive portions of the handpiece assembly examine under the microscope for any obvious damage oxidation or the presence of foreign material If any questionable characteristics are noted use a backup handpiece for surgery Use of contaminated or damaged system accessories can ca...

Page 27: ...ower switch indicates Power is Off Indicates that there are important operating and maintenance instructions included in the Owner s and Operator s Manual Indicates the presence of uninsulated high voltage inside the instrument Risk of electric shock Do not remove the instrument cover Indicates fuse Single phase alternating current Patient applied part is isolated from earth ground Patient applied...

Page 28: ...al Device Directive Separate Disposal Collection Required Environment Friendly Use Period in Years RoHS Indicates compliance with IEC 60601 1 2 2001 Electromagnetic Compatibility Requirements and Tests for Medical Electrical Equipment ETL Listed Mark issued to those products that have met the requirements of product safety standards for the United States and Canada ETL formerly Edison Testing Labo...

Page 29: ...Pedal Icon Shows the position of the footpedal when the footpedal is pressed The number shown changes when the position is changed Advanced Control Pedal Dual Linear Icon Shows the position of the footpedal when the footpedal is pressed The number shown changes when the position is changed The letters indicate the location of Aspiration A Irrigation I Phaco P Reflux R Whitestar Increment Decrement...

Page 30: ...nent s size prohibits marking such as handpieces the marking can be found on the directions for use and the warranty Treatment and or recycling of the electronic equipment are provided at no cost to you Please see the contact information below for disposition of unwanted AMO electronic equipment For disposal of your unit contact your local AMO subsidiary or the AMO service center nearest you Belgi...

Page 31: ... 61 Netherlands AMO Netherlands B V Kantoorgebouw La Residence Weverstede 25 3431 JS Nieuwegein The Netherlands Phone 31 0 30 600 8787 Norway Distributor Advanced Medical Optics Norway AS c o Advanced Medical Optics Norden AB Kanalvagen 3A SE 194 61 Upplands Vasby Sweden Poland Distributor Oko Vita Polska sp z o ul Marywilska 34 03 228 Warsaw Poland Portugal Advanced Medical Optics Spain S L sucur...

Page 32: ... Names and Content of Toxic and Hazardous Substances or Elements Parts Name Toxic and Hazardous Substances or Elements Pb Hg Cd Cr6 PBB PBDE Housing x o o x o o Power Supply x o o x x x Motherboard x o o o x x Rear Panel Assembly Board x o o x x x Pneumatics x o o x o o LCD x x o o x x Base Unit x o o o x x Fluidics x o o x o o o Indicates that this toxic or hazardous substance contained in all of...

Page 33: ... the compressed air line to the compressed air receptacle optional 4 Turn the system On at the back of the console 5 Press the On Off button on the Touch Screen monitor 6 After completion of the Start Up Self Test select the surgeon and program 7 Install the tubing cassette attach the required accessories phaco vitrectomy or diathermy handpieces and set up the tubing 8 Prime and tune the handpiece...

Page 34: ...scope for any obvious damage oxidation or the presence of foreign material If any questionable characteristics are noted use a backup handpiece for surgery Use of contaminated or damaged system accessories can cause patient injury 1 Use caution to prevent burns when handling the handpiece directly from sterilization 2 Remove the tubing cassette and accessories from the tubing pack and place them i...

Page 35: ...E A BROKEN TIP WHEN ULTRASOUND IS APPLIED Figure 3 2 Phaco Handpiece Assembly 4 Attach the connector end of the handpiece to the phaco receptacle on the front of the WHITESTAR SIGNATURE System Make sure there is no moisture on the connectors prior to connecting Moisture prevents the handpiece from operating properly Figure 3 3 Ellips Handpiece Note The Ellips handpiece can be used with WHITESTAR T...

Page 36: ...k 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 Load the FUSION Tubing Cassette 1 Open the tubing pack packaging 2 Install the FUSION cassette into the side receptacle as shown below 3 Make sure that the drainage bag is properly attached to the cassette 1 2 4 3 5 1 Infusion Sleeve 4 SOLOTM...

Page 37: ... the valve cannot operate properly and irrigation cannot flow 1 Place a new bottle of balanced salt solution on the top of the system console 2 Insert the drip chamber spike into the balanced salt solution bottle 3 Hang the balanced salt solution bottle from the Programmable IV Pole and squeeze the drip chamber 4 Fill the drip chamber with fluid to the half full level The Programmable IV Pole move...

Page 38: ...red 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 ...

Page 39: ...y available Contact your AMO representative Vitrectomy If vitrectomy is indicated during surgery 1 Connect the AMO Vitrectomy Cutter as shown below Vitrectomy requires the following components IA Tubing from FUSION Tubing Cassette Vitrectomy Cutter Vitrectomy Infusion Sleeve or a 23 Gauge Limbal Infusion Needle if desired 2 Assemble the handpiece using the instructions provided with the vitrectomy...

Page 40: ...al that you understand the footpedal operation The System software automatically detects if a footpedal and what type of footpedal is connected during power up The footpedal settings and adjustments can be selected and preset for the footpedal in the Configuration screen Instructions for the footpedal settings are given in Chapter 5 Anterior Segment Surgery Operating Modes The footpedal housing in...

Page 41: ... shown below The Advanced Control Pedal has two Yaw switches Figure 3 13 Footpedal Pitch and Yaw Positions The footpedal position determines the function that is delivered by the handpiece which depends on the mode selected on the touch screen When the footpedal has been connected place your foot on the pedal and press to the desired position The footpedal settings and programming are addressed in...

Page 42: ...ck OPO70 and as such is not intended to clear a clogged handpiece However reflux can be used to identify a blockage The reflux action can be programmed on any available footpedal switch When Reflux is activated the system reverses the peristaltic pump This causes fluid to be expelled from the aspiration line into or towards the eye The reflux is active until the footpedal switch is released The FU...

Page 43: ...le is adjustable from 0 to 104 centimeters and can be set for either inches or centimeters The height measurement is relative to the distance from the irrigation valve to the center of the drip chamber The Programmable IV Pole height for each fluidic mode or submode PHACO IA VIT is saved in the WHITESTAR SIGNATURE System memory A Maximum IV Pole height can be set on the Diagnostics screen When a s...

Page 44: ...se store the Wireless Remote Control on the top of the system to charge the batteries After you turn the system On press the Remote Control Backlight button to activate the Remote Control When the system is Off the Remote Control is in a power save mode Note After four to six minutes of idle time the Remote Control goes into a power save mode To turn the Remote Control on press the Backlight butto...

Page 45: ... is used to record the surgery and the instrument settings to be viewed at a later date and time The surgery is displayed on a monitor with the instrument settings The SMC hardware is connected to your WHITESTAR SIGNATURE System Communications port on the rear panel See Figure 3 1 Rear Panel Connections 1 To configure the Surgical Media Center select Configuration System Configuration SMC ...

Page 46: ... on the number in the control panel to open a numeric keypad and enter the required value Press Enter on the Keypad pop up window when you are finished Figure 3 17 Numeric Keypad Pop up Window 3 Select the Recording Mode Off On or Automatic If the Recording Mode is On the recording continues between cases Automatic stops recording between cases Note The Footpedal Switch can be set up to activate t...

Page 47: ...t the prompt select Yes 3 Wait for shutdown sequence to complete 4 Turn the system Off at the back of the console 5 Remove the power cord from the power outlet 6 Wrap the excess power cord neatly around the cord wrap on the back of the console 7 Place the footpedal in the storage area on the console 8 Place the Wireless Remote Control on top of the console to charge 9 Refer to Chapter 9 Care and C...

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Page 49: ...1008 4 1 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 4 EQUIPMENT OPERATION ...

Page 50: ... on the screen As adjustments to settings are made the screen shows the changes The screens and controls are shown below Each Anterior segment surgery mode and submode has their own distinct screen setup Irrigation Aspiration Phaco without OCCLUSION MODE Phaco with OCCLUSION MODE and or CASE FUSION MODE Phaco with Ellips technology Vitrectomy Diathermy Figure 4 1 PHACO Screen Additionally there ar...

Page 51: ...access the Select Language screen from the main screen select Configuration System Configuration Language 2 Select the desired language from the listing 3 Press Yes at the confirmation pop up The screen automatically changes to the selected language 4 Press Exit Settings to proceed with the selected language Figure 4 2 Language Screen Note On any screen if you press the screen about 25 times the S...

Page 52: ...ure 4 3 Self Test After start up the screen shows the available Surgeons and Programs that can be selected You can now select a Surgeon and a Program A Program or Surgeon Name is a set of pre established operating settings for each operating mode The WHITESTAR SIGNATURE System allows you program up to a maximum of 50 Surgeon names and 20 customized surgeon setups programs for each surgeon ...

Page 53: ...d the System proceeds immediately to the tubing cassette installation screen From the Main Menu you can Select a Surgeon Program and begin surgery based on the values of that program Enter the Settings Configuration page where you can edit add or delete programs and setup operating parameters Enter the End Case screen Refer to Chapter 5 Anterior Segment surgery Operating Modes End Case ...

Page 54: ...s as a starting point You can modify the settings and Save As a specific program or surgeon name The system does not let you overwrite the AMO Default Program when you press SAVE If a surgeon only has one program set up this screen is not shown and the System proceeds immediately to the tubing cassette installation screen for the type of program that is set up for that surgeon The System automatic...

Page 55: ...e amount needed either 30 60 or 90 cc to fill the cup and then press Start The Cup Fill stops when the selected amount is dispensed or Stop is pressed You can still use Continuous Irrigation to fill cups IA Prime is designed for a procedure that does not require a phaco handpiece Tune is designed for a quick tune of the phaco handpiece with an IA tubing set Tune can be used if a phaco tip is repla...

Page 56: ...IR EXPOSURE OF THE TIP TO AIR DRASTICALLY REDUCES THE USEFUL LIFE OF THE HANDPIECE IF POWER IS TO BE INTRODUCED TO THE PHACO HANDPIECE OR VITRECTOMY CUTTER THE TIP MUST BE IN A TEST CHAMBER FILLED WITH BALANCED SALT SOLUTION IN A CONTAINER OF BALANCED SALT SOLUTION OR IN THE PATIENT S EYE Suggestions for Priming the Handpieces Always fill the test chamber completely prior to running the Prime Tune...

Page 57: ... low ceilings 5 Watch the fluid fill the drip chamber The fluid moves toward the handpiece and fills the test chamber 6 The touch screen indicates the progress of the Prime and Tune process 7 As the tubing lines are filled the system software performs functional checks The checks include Monitoring for the presence of irrigation flow bottle height Leaks via vacuum rise checks 8 If the phaco handpi...

Page 58: ...ition 2 Make sure the footpedal is connected Refer to Chapter 3 System Setup Footpedal 3 The actual vacuum level should rise to the preset level 4 Release the aspiration line and watch the test chamber to make sure that the test chamber does not collapse A slight shallowing of the test chamber is normal 5 If the test chamber collapses raise the IV bottle height or lower the vacuum setting 6 Pinch ...

Page 59: ...ctomy handpiece If you do not need to prime press Bypass To prime the handpiece 1 Attach the irrigation and aspiration cassette pack tubing together 2 Press Prime on the Prime Tune screen 3 Press the VIT button to enter VIT mode 4 Follow the instructions on the screen 5 Press Start Vit Prime The screen closes automatically when the handpiece is primed Note If you must perform vitrectomy in the mid...

Page 60: ...e left side column lists the operating modes and submodes The main panel that dominates the screen shows current operating levels for aspiration vacuum and power To switch operating modes or submodes press a button in the left panel The control panels in the main panel show the operating levels for that mode To make basic changes to the settings press the Up and Down arrows to increase or decrease...

Page 61: ...STAR SIGNATURE System Rx Only Z370147 Rev C 1008 4 13 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 ...

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Page 63: ... Rev C 1008 5 1 Operating Mode Descriptions Fusion Fluidics Phaco Programming the Modes and Settings Anterior Segment Recommended Settings OCCLUSION MODE Phaco Settings Passive Reflux Ellips Technology 5 ANTERIOR SEGMENT SURGERY OPERATING MODES ...

Page 64: ...ates the Prime Tune status and any messages associated with the prime and or tune The WHITESTAR SIGNATURE System provides power for bipolar coagulation or diathermy The amount of diathermy power is shown on the Diathermy screen If Panel power is selected you can increase or decrease power by pressing the Up or Down arrows on the Power control panel If the Linear mode is selected the power is contr...

Page 65: ...p or Down arrows If Linear power is selected you can use the footpedal to increase or decrease the power up to the maximum preset value To change the power delivery press Settings The Settings window opens Set the power delivery to Panel Linear or Burst Linear delivery is the default Panel Diathermy power is delivered consistently at the power level selected and indicated on the screen as Panel Ma...

Page 66: ...ion Aspiration Aspiration flow is necessary to remove the emulsified cataract material from the eye An irrigation supply is necessary to replace fluid removed by aspiration of cortical material and fluid lost to leakage from the incision This fluid balance maintains the anterior chamber during surgery Irrigation is controlled by gravity The flow rate of irrigation solution through the irrigation s...

Page 67: ...selected by default 3 Press the Up or Down arrows in the control panels on the main panel to increase or decrease Aspiration Rate or Vacuum Note If the Venturi pump is On only the Vacuum Settings are shown To turn the Venturi pump setting on use the IA Submode Configuration screen 4 Press the Settings button in the control panels on the main panel to change Aspiration Mode or Vacuum Mode 5 Press F...

Page 68: ...igure 5 5 Continuous Irrigation Phacoemulsification The purpose of phacoemulsification or PHACO is to emulsify the lens material The phacoemulsification phaco handpiece provides ultrasonic energy irrigation and aspiration simultaneously so that the lens material is extracted as it is emulsified The phacoemulsification handpiece has a hollow needle that vibrates longitudinally at an ultrasonic freq...

Page 69: ...control allows you the ultimate control during phaco Adjustments to phaco power depend on factors that include nuclear density your preferences and your experience Phacoemulsification mode lets you set four submodes with different settings You can adjust the individual parameters of each submode Figure 5 6 PHACO Submodes For each PHACO submode you can change the following settings Aspiration Rate ...

Page 70: ...Program PHACO 1 Press the PHACO button 2 Press the desired submode button Phaco 1 is selected by default Note You can set your Initial Mode Submode on the Phaco Configuration screen The Initial Mode Submode is then your default setting Refer to Program Configuration in this chapter 3 In the control panels in the main panel click the Up or Down arrows to increase or decrease Aspiration Rate Vacuum ...

Page 71: ...TAR Technology The WHITESTAR Technology can be applied in any phaco power delivery mode This technology is an advanced phacoemulsification power mode that delivers finely modulated pulses of energy interrupted by extremely brief cooling periods This technology is available in Linear or Panel mode When the WHITESTAR delivery mode is turned on either or appears on the touch screen along with the WHI...

Page 72: ... different duty cycles are applied as the footpedal moves through the power delivery zone The zone is divided into four equal size quadrants and a different duty cycle can be applied in each quadrant Setting Pulse On Time ms Pulse Off Time ms Duty Cycle Pulse Rate pps 6 12 6 12 33 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 ...

Page 73: ...tpedal Positions and Duty Cycles 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 1 Footpedal Position 3 2 WHITESTAR Duty Cycle ...

Page 74: ...which combined modulated ultrasonic power pulse shaping with vacuum control through the application of the Chamber Stabilization Environment CASE This pulse shaping technology modified the standard square wave pulse by increasing the amplitude of the first millisecond of the On Time kick and then setting the remaining part of the On Time to the standard power setting This is repeated for each On T...

Page 75: ...ss the WHITESTAR ICE Technology settings 1 Press the Power Settings button 2 Press the WHITESTAR mode button 3 Press On for Pulse Shaping 4 Press Edit to access the Pulse Shaping parameter settings 5 Press Finished to close the screen Continue to press Finished to return to the main screen 1 Kick Amplitude 3 Burst Width 2 1 Millisecond Kick 4 Phaco Power Level ...

Page 76: ...termine the amplitude or amount of Phaco Power kick that is applied in the first millisecond of Phaco Power application either in the low end or the high end of the power range As the Phaco power increases from the Low Power limit to the High Power Limit the percentage of kick is interpolated for the power ranges in between the two limits As an example if a small kick setting is established for th...

Page 77: ...imum allowable vacuum setting to a lower predefined CASE maximum vacuum level When the occlusion is cleared the System is automatically restored to the original programmed maximum vacuum setting It is possible to have a different maximum vacuum setting when the needle is occluded than when the needle is not occluded The power modulation of the phaco handpiece can be programmed to automatically cha...

Page 78: ...s maintained for the amount of time defined by the Up Time Threshold Lower Threshold Down After the occlusion is cleared the vacuum is reduced to the lower vacuum threshold setting to allow the occlusion to be safely cleared and then gradually returned to the previous levels 4 Use the Right and Left arrows in the graphic to change the Up Time Threshold The Up Time Threshold is the maximum time tha...

Page 79: ...ation mode The cutting speed can be changed on the touch screen There are four adjustments related to the Vitrectomy mode Aspiration Rate Vacuum Cut Rate Footpedal CAUTION THE PHACO HANDPIECE AND VITRECTOMY CUTTER MUST NEVER BE ACTIVATED WITH THE TIPS IN THE AIR EXPOSING THE TIP TO AIR DRASTICALLY REDUCES THE USEFUL LIFE OF THE HANDPIECE IF POWER IS TO BE INTRODUCED TO THE PHACO HANDPIECE OR VITRE...

Page 80: ...my handpiece Refer to Chapter 4 Equipment Operation Priming for Vitrectomy for detailed information Figure 5 17 Vitrectomy Mode Screen 1 In the main panel press the Up or Down arrows to increase or decrease the Aspiration Rate Vacuum or Cut Rate Note If the Venturi pump is On only the Vacuum and Cut Rate Settings are shown 2 To program the footpedal go to Configuration Surgeons and Programs Foot P...

Page 81: ...m Rx Only Z370147 Rev C 1008 5 19 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 ...

Page 82: ... the cutter at the panel rate for Side VIT only Table 5 2 Vitrectomy Single Linear Footpedal Modes Table 5 3 Vitrectomy Advanced Control Pedal Dual Linear Modes Footpedal Positions Vitrectomy Footpedal Modes ICA IAC Side VIT 1 Irrigation Irrigation Irrigation 2 Irrigation Cut Irrigation Aspiration Irrigation Aspiration 3 Irrigation Cut Aspiration Irrigation Aspiration Cut Irrigation Aspiration Foo...

Page 83: ...ures and options pertinent to general operation for each mode and submode the footpedal system sounds and the system database When the AMO Default Program is selected all of the modes and submodes are preset Although these settings can be changed they cannot be saved Use the defaults as a source to your system settings All default settings can be easily viewed on the Mode Configuration screens Fig...

Page 84: ...surgeon program setup Sounds Available Settings AMO Default Settings High Vacuum On Off On Mode Change Off Tone Voice Voice On Submode Change Off Tone Voice Voice On Value Change On Off Voice On Activity Confirmation On Off Voice On Vacuum Off 10 6 Diathermy 5 10 6 Phaco Power Off 10 Off Error 5 10 6 Irrigation Off 10 3 Key Press Off 10 6 Speech Off 10 6 CASE Activation 0 10 5 Master Volume 0 10 1...

Page 85: ... WHITESTAR SIGNATURE System Rx Only Z370147 Rev C 1008 5 23 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 ...

Page 86: ...lux Pitch Region 1 100 P1 5 P2 30 P3 60 Yaw Position 5 100 Left 50 Right 50 Switch Position Switch1 Switch 2 Switch1 Off Switch 2 Off Yaw Threshold 5 100 5 Feedback On Off Off Surgeon Program Up Surgeon Program Down Previous Major Mode Next Major Mode Previous Active Mode Next Active Mode Previous Sub Mode Next Sub Mode Toggle SMC Record Bottle Up Bottle Down Reflux Continuous Irrigation 1 Touch U...

Page 87: ...nches 50 cm 20 inches 50 cm 20 inches Max Vacuum 0 650 mmHg 500 mmHg 500 mmHg 15 mmHg Max Aspiration Mode Peristaltic 0 60 cc min 26 cc min Panel 26 cc min Linear 6 cc min Panel Peristaltic Pump Ramp Threshold 10 100 80 80 80 Venturi Pump On Off Off Off Off Passive Reflux Fusion Fluidics Pack Yes No Yes Yes Yes Passive Reflux Fusion Dual Pump Pack Yes No Yes Yes Yes Initial Mode Submode Any of the...

Page 88: ...low Aspiration Rate Unoccluded Peristaltic 10 60 cc min 18 cc min 24 cc min 18 cc min 24 cc min Fluidics Mode Panel Linear Panel Aspiration Linear Vacuum Panel Aspiration Panel Vacuum Panel Aspiration Linear Vacuum Panel Aspiration Linear Vacuum Occlusion Threshold 0 Max Vac 25 mmHg 140 mmHg 60 mmHg 80 mmHg OCCLUSION MODETM Phaco On Off Off On On Off CASE Mode On Off Off Off On On CASE Upper Thres...

Page 89: ... Off Power Delivery Type Occluded Linear Panel Linear Linear Linear Linear Customized to Each Surgeon Program Setup AMO Default Settings Parameter Available Settings VIT 1 VIT 2 Bottle Height 0 104 cm 0 42 inches 30 cm 12 inches 30 cm 12 inches Continuous Irrigation On Off Off Off Pump Selection Venturi Peristaltic Peristaltic Peristaltic Max Vacuum Mode Peristaltic 0 650 mmHg Panel Linear 225 mmH...

Page 90: ...spiration rate from 0 to 60 cc per minute 2 Press the Settings button to select Linear or Panel aspiration flow The Settings panel appears 3 Press the Linear or Panel button The Linear vacuum rate is linear with respect to the footpedal position As the footpedal is pressed through Position 2 the vacuum level travels between 0 mmHg and the maximum preset level as occlusions at the aspiration port o...

Page 91: ...ements of 50 CPM between 100 1000 and 100 CPM between 1000 2500 CPM Some surgeons prefer a higher rate which allows the surgeon to perform the same amount of cutting with smaller bites of vitreous This minimizes motion and is gentle on the tissue To adjust the cut rate 1 On the Cut Rate panel press the Up or Down arrows to increase or decrease the cut rate 2 Press Settings to select either Linear ...

Page 92: ...s The Switch Assignment screen opens when you select On for any of the switches on the Foot Pedal selection screens The Switch Assignment screen allows you to make a selection for that switch Footpedal Settings From the top panel of any operating screen press Configuration The program highlighted on the Main Menu is used 1 Press Surgeons and Programs in the pop up window 2 In the side panel press ...

Page 93: ...resholds 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 ...

Page 94: ...ht or right to left 9 Select the operating modes for that surgery using the top Mode tabs and complete the footpedal setup for each mode PHACO IA VIT or DIA The footpedal settings are shown in the center of the screen Select Summary to view the footpedal settings for all of the modes 10 Press each of the switches in any of the four modes A pop up window is shown for each switch 11 Select the Switc...

Page 95: ...x Only Z370147 Rev C 1008 5 33 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 ...

Page 96: ...om the footpedal results in a quicker vacuum rise time A slower flow rate results in a slower vacuum rise time The Panel flow provides a constant evacuation at the preset flow rate when the footpedal enters Position 2 End Case End Case is available in the top panel from any programming or surgical mode End Case allows you terminate the programming session or surgical case If changes were made to t...

Page 97: ...Effective Phaco Time is ultrasound time as a weighted total that takes into account the amount of power being used at 100 power 1 sec U S Time 1 sec EPT at 50 power 1 sec U S Time 5 sec EPT Current Case Review Case shows the graphical history of the surgery Refer to Figure 5 28 Review Case Screen 1 Select a shorter time interval to adjust the Time Line Duration and to see greater case details For ...

Page 98: ... History Note Use only AMO recommended USB stick drives 5 Use the Print to File to save the data to a file format The Delete Record button removes the case from the Record database 6 Select Finished to close the window Figure 5 28 Review Case Screen Continue Case Select Continue Case to return to the current case after you selected Review Case or Restore Shutdown Select the Shutdown button to turn...

Page 99: ... level is at the maximum preset level The power increase is indicated by the power display bar 2 Panel Power is delivered consistently at the power level indicated on the screen The power level does not change when you press the footpedal There are eight choices for delivery of phaco power Continuous Short Pulse Long Pulse Low Power Pulse High Power Pulse Single Burst Panel only Multiple Burst Pan...

Page 100: ...ght of the Short Pulse button To set the Short Pulse range 1 Press the button to the right of the Short Pulse button A Settings pop up window appears 2 Press the Up or Down arrow to increase or decrease the pps from 1 to 14 3 Press Finished to close the window Long Pulse Phaco Power Long Pulse delivers Phaco in pulses of 150 ms when the footpedal is in Position 3 You can set this in a range of 1 t...

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