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110017276EN Rev B StellarisPC Manual.indb

1. Figure 2 25 Phaco More Settings Screen Tab 110017276EN Rev B Operator s Manual 2 21 2 User Interface Coagulation More Settings Screen Tab The Coagulation More Settings Screen tab shows the current minimum and maximum power levels and the Foot Control mapping mode You can adjust either power level setting Power Level Min U Max Figure 2 26 Coagulation More Settings Screen tab 2 22 Operator s Manual 110017276EN Rev B 2 User Interface p Cut More Settings Screen Tab The Cut More Settings Screen tab shows the current settings for the minimum and maximum CPM cuts per minute You can adjust either setting The current Foot Control preview is also shown For submodes with fixed cutting only one cut rate will be displayed For Anterior Procedures Foot Control mapping is not adjustable from this popup Figure 2 27 Cut More Settings Screen Tab 110017276EN Rev B Operator s Manual 2 23 2 User Interface Footpedal More Settings Screen Tab The Footpedal More Settings Screen tab has three buttons that allow you to view and edit Settings Regions and the Status of the Foot Control These functions are described in detail in the Foot Control section see page 1 40 The Settings Button shows the current status of the Foot Control switches right or left foot operation Dual Linear Control Mode Change Control Next U S Ultrasound Modula
2. Ultrasound Infusion iluminators Vacuum mg e mmm Surgeon Settings Z CET i A regaz Start Q N Z CO d Figure 2 29 Footpedal More Settings Screen tab Regions button 2 26 Operator s Manual 110017276EN Rev B 2 User Interface E The Status button shows the current status of several footpedal options including communication status battery status and signal strength Figure 2 30 Footpedal More Settings Screen tab Status button 110017276EN Rev B Operator s Manual 2 27 2 User Interface A V More Settings Screen Tab The A V More Settings Screen tab has three buttons that allow you to change many aspects of the audio and visual displays Each button allows you to change the settings and configuration for aspects of the display The Audio button allows you to control the master volume for the system as well as the specific tone and volume used for each of the following events Irrigation Vacuum Occlusion Ultrasound Coagulation Vitrectomy and Alert The selected tone will be played when that function is active and the frequency of the tone will change with the value of the function Figure 2 31 A V More Settings Screen tab Audio button Select the tone you want to change then use the menu and arrows on the right side of the screen to select the tone used for that condition and the volume at which the tone will be played Only tones not currently in
3. oes 5 1 Bipolar Coagulation ACCOSSOTIeS i ee HR OE ER HERES e eee OH REPE UNI A ie Be 5 2 Irrigation and Irrigation Aspiration Hand pieces essere enne eene rennes 5 3 Ultrasound Handpiece and Accessories cn oriri rt en I p Ce EE PT i trap dee AER 5 6 Special Instructions for United Kingdom Users eese nnns 5 11 Cleaning the MM cierto et ect ti OE RO ae UR Ro ti dert it Aes Lie ede Ee 5 14 Troubleshooting User Troubleshooting 5 er oit e teach EUN e o v tee bete bur Rein 6 1 el E E 6 1 Errorand Warning Messages iuto oro qure E C S RR sabiesd DO EE OT une 6 3 Troubleshooting the MMC ici SB ieee HIRED ENER 6 19 System Configurations Modules Accessories and Dacks 6 20 Service and Warranty Service ege re EE 7 1 Environmental Protectioti EE 7 10 Warranty Information iter etie er CRT rp reg e EROR HE RS PEE SI ser ped dire er ten 7 10 Specifications Environmental and Physical Specifications esses eene nennen nennen nnne 8 1 Primary System Specifications s ton reto gd tree n ped in RR E ET CURT RE gu a e HERE HERR EUG 8 8 System d e 8 18 Glossary 110017276EN Rev B 1 Getting Started Getting Started This chapter is for people who have used this type of ophthalmic vision enhancement system before and want to use the system without reading large portions of the man
4. Ultrusecest Modulates Contes Hiren i EEN Continusus A Power Level mmm wur Foot Contret Mapping Lises Figure 2 62 Ultrasound More Settings Screen Continuous Ultrasound 110017276EN Rev B Operator s Manual 2 57 2 User Interface Figure 2 63 Ultrasound More Settings Screens Pulsed Ultrasound 2 58 Operator s Manual 110017276EN Rev B 2 User Interface E Coagulation More Settings The Coagulation More Settings Screen shows the current minimum and maximum power levels and the Foot Control preview You can adjust either power level setting Figure 2 64 Coagulation More Settings Screen 110017276EN Rev B Operator s Manual 2 59 2 User Interface Vitrectomy More Settings The Vitrectomy More Settings Screen shows the current settings for the minimum and maximum CPM cuts per minute Figure 2 65 Vitrectomy More Settings Screen You can adjust either setting The current Foot Control preview is shown for reference 2 60 Operator s Manual 110017276EN Rev B 2 User Interface ESSE Foot Control More Settings The Footpedal More Settings Screen has three tabs that allow you to view and edit Settings Regions and the Status of the Foot Control These functions are described in detail in the Foot Control section see page 1 40 The Settings Tab shows the current status of the Foot Control buttons right or left foot operation Dual Linear Control Mode Change Con
5. Restore a Settings File To restore an existing surgeon preference file from a USB memory device select the Restore Tab from the Manage Settings Screen then insert the device into one of the two USB ports on the back of the system console behind the round sliding door Make sure the Restore Tab is active at the top of the Manage Settings Screen select the file or files to be restored and select Confirm e Note You must select the Restore Settings File screen first then insert the device The system will only recognize a USB device after this screen is selected Surgeon Settings Figure 3 13 Restore Settings File Screen 3 16 Operator s Manual 110017276EN Rev B 3 Customizing Your System rr il Delete a Settings File To delete an existing surgeon preference file select the Delete Tab from the Manage Settings Screen select the file or files to be deleted and select Confirm Figure 3 14 Delete Settings File Screen 110017276EN Rev B Operator s Manual 3 17 3 Customizing Your System 3 4 System Setup Select System Setup from the Main Programming Screen and a new screen will appear through which you can set the Date Time for the system view the System IDs and set operating room parameters Any changes you make here are implemented immediately Set Date Time and Language To change the system language current date time or format in which the time is displayed select the Date
6. Set and programmed for a left footed operator with the pedal home position offset to the right of center by approximately 5 to give approximately 15 of motion to the left and approximately 5 of motion to the right See Dual Linear Yaw Control below e Set and programmed for a right or left footed operator with the pedal home position in the center giving approximately 10 of motion in both directions The pedal offset switch indicator must align with either left right or center pedal offset position Failure to align the indicator appropriately will cause the Foot Control to become inoperable Left or right offset position selections strictly follow system software programming for Left or Right foot operations For example if the system is programmed to right foot operation the indicator 4 can only be set to Center 6 or Right Offset Position 7 only Refer to Figure 1 39 on page 1 57 1 56 Operator s Manual 110017276EN Rev B 1 Getting Started Figure 1 39 Pedal Offset Switch Indicator 4 and Pedal Offset Positions 5 6 and 7 4 Pedal Offset Switch Indicator 5 Left Offset for system setup of left foot operation 6 Center Position for system setup for left or right foot 7 Right Offset for system setup for right foot operation Single Linear Setup In Fixed Cut Vitrectomy Mode the outward yaw movement provides ON OFF cutting control Each successive outward movement toggles the programmed tool ON
7. BAUSCH LOMB Stellaris 77 GE i ual f lil N D CR E Bausch amp Lomb Incorporated No part of this publication may be copied photocopied reproduced translated or reduced to any electronic medium or machine readable form in whole or in part without the prior written consent of Bausch amp Lomb Incorporated Rochester NY 14609 USA denote trademarks of Bausch amp Lomb Incorporated All other products brands are trademarks of their respective owners Manufacturing site wl Bausch amp Lomb Incorporated fec Rochester NY 14609 USA Bausch amp Lomb Incorporated CE Bausch amp Lomb Incorporated ONLY 106 London Road Kingston upon Thames KT2 6TN UK 1275 3365 Tree Court Industrial Blvd St Louis MO 63122 110017276EN Rev B BL3253EN Preface Indications for Use The Bausch Lomb Stellaris PC Vision Enhancement System device is intended for the emulsification and removal of cataracts anterior and posterior segment vitrectomy The system is designed for use in both anterior and posterior segment surgeries It provides capabilities for phacofragmentation coaxial or bimanual irrigation aspiration bipolar diathermy vitrectomy viscous fluid injection removal and air fluid exchange operations A WARNING Use only Bausch Lomb approved disposable packs tubing sets and Bausch Lomb handpieces designated for use with this system Safety may be degraded if accessories not me
8. Illumination and viscous fluid control are not available The light module has failed to respond to Warning a settings command The module settings have been re sent to the module The light module has reset The module Warning settings have been re sent to the module 6 Troubleshooting Suggested Action s SOU Call your product service representative SG02 Call your product service representative A compatible software version must be downloaded SG93 Confirm correct illuminator and viscous fluid control function SG04 Call your product service representative if this problem persists SG93 Confirm correct illuminator and viscous fluid control function SG04 Call your product service representative if this problem persists LMO5 Warning Ir Kee SG94 Replace the upper illuminator bulb of life E Eum EES SG95 Replace the lower illuminator bulb Warnin The illuminator temperature is too high SG04 Call your product service The illuminators have been turned off representative if this problem persists SG97 Wait for the system to reach room arning The illuminator temperature is too low W temperature then try again W SG04 Call your product service representative if this problem persists Go Go LM11 Warning The illuminator filter control has failed Scie ies produet eode representative if this problem persists LMI2 Warning The upper illuminator brightness control SG04 Call your prod
9. Must be done before step 4 4 Place the black piston into the syringe barrel and use the plunger to push the piston all the way down to the tip of the syringe Refer to Figure 4 18 and Figure 4 19 A WARNING Ensure a black piston is in the syringe before connecting the syringe coupler to the syringe Failure to do so will cause fluid to be aspirated into the system s electronic components 5 Connect the syringe coupler of the Viscous Fluid tubing to the empty syringe Twist the coupler to lock it securely to the syringe Refer to Figure 4 20 6 Connect the extraction needle to the syringe The 19 gauge steel needle is suitable for this application 7 Remove the cannula cover 8 before use 8 Select Visc Extract from the Surgical Screen clock menu to perform the VFC extraction procedure 5 Figure 4 18 Viscous Fluid Extraction Setup Inserting Piston 4 into the empty syringe 5 5 Figure 4 19 Viscous Fluid Extraction Setup Use plunger 9 to push piston 4 to the end of the empty syringe 5 4 26 Operator s Manual 110017276EN Rev B 4 Detailed Reference Figure 4 20 Viscous Fluid Extraction Setup 1 Viscous Fluid Port 2 Air Tubing Connector 3 Coupler 4 Piston 5 Empty Syringe 6 Syringe Cap 7 19g Teflon Cannula 8 19g Extraction Cannula 9 Plunger Viscous Fluid Extraction Operation Modes Fixed Extract Extraction is activated when the footpedal is depressed
10. or use the filter button on the surgical screen to toggle filter selection none amber green yellow You can also select the filter from the More Settings screen 110017276EN Rev B Operator s Manual 4 13 4 Detailed Reference By default the filter is set to None To change this edit your surgeon preferences file see page 3 9 The output level should be set in accordance to the guidance shown in the detail section on page 1 61 Lamp Life Cycle As the lamp ages its operating voltage will naturally increase In some cases it may increase beyond an acceptable level before the normal number of operating hours have elapsed In this case the Stellaris PC Vision Enhancement System will prevent further use of the lamp to avoid the possibility of lamp rupture If the lamp takes longer than usual to strike or fails to strike this indicates the lamp is nearing the end of its life and a warning message may appear on the screen Each lamp has a maximum number of hours of life and the system will provide a warning when that limit is near and again once the limit has been reached Once the limit has been reached the lamp will remain on for the current surgery but once turned off will not turn on again and must be replaced The amount of lamp life remaining for each lamp is displayed in the Illumination More Screen The display represents the remaining hours of lamp life The Green area represents the amount of hours of life remaining pri
11. Figure 2 19 Extrude More Settings Screen tab 110017276EN Rev B Operator s Manual 2 15 2 User Interface Figure 2 20 I A More Settings Screen tab 2 16 Operator s Manual 110017276EN Rev B 2 User Interface Irrigation Figure 2 21 Irrigation More Settings Screen tab 110017276EN Rev B Operator s Manual 2 17 2 User Interface Figure 2 22 Linear Coagulation More Settings Screen tab 2 18 Operator s Manual 110017276EN Rev B 2 User Interface Vacuum More Settings Screen Tab The Vacuum More Settings Screen tab has options that control the maximum and minimum vacuum allowed venting method and mapping of these options to the Foot Control Figure 2 23 Vacuum More Settings Screen Tab 110017276EN Rev B Operator s Manual 2 19 2 User Interface Ultrasound More Settings Tab The Ultrasound More Settings Screen tab shows the current modulation status and power level Depending on which type of ultrasound you are currently using you may also see power level number of pulses per second PPS duty cycle DC burst duration BD and pulse interval PI waveform type waveform depth waveform duration and Foot Control preview You can adjust any of these settings Hemes mum nu S Ya Waveform Ultrasound Figure 2 24 Fragmentation More Settings Screen Tab 2 20 Operator s Manual 110017276EN Rev B 2 User Interface
12. patient eye level offset feature in the programming screen Operator s Manual 110017276EN Rev B 1 Getting Started ZZ Zn e Note The out of factory Wireless System Setup is Disabled Performing a software upgrade will also reset the Wireless System Setup to Disabled To setup wireless operation see Wireless Foot Control Operations System Setup on page 1 46 The Stellaris PC Vision Enhancement System is pre configured at the factory to minimize setup and installation requirements The power cable Foot Control and Ethernet connections are located at the lower rear of the system Figure 1 1 Lower Rear of System 1 Fuse Holder 2 Main Power Switch disconnects system from mains voltage See IEC 60601 1 paragraph 8 6 7 3 Ethernet Port 4 Foot Control Backup Cable Port 5 Power Cord Input 6 Power Cord Retention Clip 7 Potential Equalization Connector A Note Turning off the Main Power Switch will disconnect the system from mains 110017276EN Rev B Operator s Manual 1 3 1 Getting Started Foot Control The Foot Control can use either wired or wireless communication The first time the Stellaris PC Vision Enhancement System is used you must use the wired connection to establish communication between the Foot Control and the Stellaris PC Vision Enhancement System For wired communication connect the Foot Control backup cable from the back of the Foot Control to the lower rear of the Stellaris
13. photochemical injury to the retina resulting from intense light exposure Thermal In both cases the damage is caused by the intensity of light at a given point normally called irradiance and usually measured as power per square centimeter This means that the risk of harm is increased when the illumination probe is moved closer to the retina at a distance of 5 mm from the retina the irradiance is about twice that of the probe at 7 mm e Figure 1 40 Irradiance as a function of distance For reference the lumens output of an illumination probe is a measure of the total light output at the end of a fiber For the same lumens output a focal probe has a higher irradiance and hence risk of harm than a wide angle probe because the same total light output is concentrated into a smaller area on the retina The lumens measurement also takes into account the sensitivity of the human eye to different wavelengths of light 110017276EN Rev B Operator s Manual 1 61 1 Getting Started ee Figure 1 41 Irradiance as a function of probe type Photoretinitis Sensitivity verses wavelength The retina is more easily damaged by ultra violet and violet blue light than it is by light with longer wavelengths The Stellaris PC Vision Enhancement System incorporates filters to remove ultra violet light and violet light but it is not possible to eliminate more of the phototoxic influence without significantly discoloring the ligh
14. 110017276EN Rev B Operator s Manual 6 11 6 Troubleshooting Text Message Suggested Action s iD Type USMOS ul 7 7 u The ultrasound handpiece has failed the tuning process The ultrasound handpiece may have failed or may be failing Coagulation circuit may have failed potential coagulation output over voltage condition Coagulation circuit may have failed potential uncommanded or incorrect coagulation output Unable to read ultrasound handpiece data Attempt to tune the handpiece to confirm proper operation 6 12 Operator s Manual SG52 Ensure ultrasound needle is properly tightened Select Prime Tune or Tune Only again to repeat the handpiece tuning process SG53 Unplug the handpiece and try another ultrasound handpiece SG04 Call your product service representative if this problem persists SG54 Confirm proper ultrasound handpiece operation in a test chamber SG53 Unplug the handpiece and try another ultrasound handpiece SG04 Call your product service representative if this problem persists SG55 Confirm proper operation of the coagulation handpiece in a beaker of BSS activate the function and ensure the error message does appear again If similar message appears stop using the function and call B amp L service support SG56 Unplug the handpiece and try another bipolar coagulation cord SG04 Call your product service representative if this problem persists S
15. 27 6 cm 10 875 in W 32 4 cm 12 75 in L Weight 2 7 kg 6 lbs Center pedal Pitch Linear on off Center pedal Yaw Left On Off simulated Right On Off simulated Left Linear Right Linear Function switches Increase decrease On Off Function Center pedal Pitch Motion Pitch up down Automatic return to up position Detent 2 programmable as to position may be enabled or disabled Control Provides primary linear function or on off Center Pedal Yaw Motion Yaw Left Right Automatic return to center Detent 1 center detent Non programmable control Provides secondary linear function in primary yaw direction and on off control in secondary yaw direction may be physically set for greater linear movement Function switches Motion Momentary Push button Control Provides programmable increment decrement or on off control of assigned function 8 10 Operator s Manual 110017276EN Rev B 8 Specifications az ES j Remote Control Unit Specifications Anterior Only Specification EE IR transmitter Provides operation up to 15 feet from Provides operation up to 15 feet from display console console Powered Powered from standard AA battery batteries standard AA Powered from standard AA battery batteries batteries General Low battery indicator 2 Low battery indicator 2 indicator aa aaa indicator LC Si Illuminated Iluminated keys a Vacuum Level Increase Decrease Aspiration
16. 3 4 3 13 3 18 Layout Screen 2 34 2 67 Level 1 Display 2 67 Level 2 Display 2 74 M Maximum IV Pole Height 1 35 3 32 Menu Clock 2 34 2 68 MMC MultiMedia Center 1 37 Module Computer Unit See Also Computer Unit IV Pole See Also IV Pole More Coagulation 2 22 2 58 110017276EN Rev B Index Operator s Manual Index ww Je ee More Footpedal 2 24 2 59 More Screen A V 2 28 2 63 More Screens 2 46 More Settings Fluidics 2 19 More Settings Screen button 2 7 More Settings Ultrasound 2 20 2 56 More Vitrectomy 2 59 MultiMedia Center 1 37 N Needle Cleaning 5 10 Sterilization 5 10 O Operation Capsule Polish 4 30 Control Numeric Keypad 2 3 2 43 Pop Up Window 2 6 Test Tube Control 2 2 2 42 Foot Control See Also Foot Control Operation Irrigation 4 30 Phacoemulsification Burst 4 33 Linear 4 35 Turning on System 1 7 Viscoelastic Removal 4 30 Vitrectomy Cutter Modes 4 40 Yaw Aspiration 4 36 Option List 2 41 P PD Pulse Duration 4 33 Phaco Phacoemulsification 4 33 PI Pulse Interval 4 33 Pitch 1 51 PPS Pulses Per Second 2 20 2 39 2 56 2 73 4 33 Pulse Duration PD 4 33 Pulse Interval PI 4 33 Pulses Per Second PPS 2 20 2 39 2 56 2 73 4 33 Push Bar 2 41 Operator s Manual 110017276EN Rev B R Reflux 1 51 1 55 4 30 4 41 Remote Control Specifications 8 10 Remote Control Batteries 1 35 Replacement Fuse 6 2 Restore Preference File 3 16 Rise Time
17. Insert the fluidics cassette into the slot on the front of the system and hold until it is automatically captured by the system The cassette housing backlight will stop blinking and remain on when the system captures the cassette The system will automatically conduct a vacuum sensor and calibration check Wait until the progress bar shows successful completion to proceed If the system does not pass corrective actions will be suggested Following the successful cassette check the screen will automatically advance to the Prime and Tune steps 110017276EN Rev B Operator s Manual 1 17 1 Getting Started 3 Connect the proper accessories to the system for an Anterior Posterior or Combined procedure E Note If you are using a vented Air Forced Infusion AFI pack make sure to connect the Fluid Air Exchange filter to the F AX port on the front of the machine Detailed setup instructions for each configuration are provided in Chapter 4 Use the following list to navigate to the appropriate page and surgical setup instructions for the desired configuration Posterior Domain e Vitrectomy See page 4 7 e Illumination See page 4 12 e Fluid Air Exchange See page 4 19 e Viscous Fluid Injection See page 4 24 e Viscous Fluid Aspiration See page 4 25 Linear Fluid Injection Linear Vacuum See page 4 27 Fragmentation See page 4 28 Anterior Domain e Irrigation Aspiration See page 4 31 e Phacoemulsification Se
18. MicroFlow Thin Tip Coaxial MICS Stable Flow 20 Gauge Stable Flow 19 Gauge IV Pole bottle height 30 to 140 cm by 5 cm Technique Phase Case Irrigation Delay 100 to 3000 ms steps of 50 milliseconds Also resolution Technique of 50 ms even with calculator Phase Case Vacuum Response 1 Fastest 2 3 4 5 Slowest Technique Phase Case Vent Method Fluid Venting Air Venting Technique Phase Case Aspiration type Fixed vacuum Phase Case i Fixed vacuum with aspiration control feature Anterior Domain Types available depend on Linear vacuum aspiration types enabled at Linear vacuum with aspiration control feature the technique level the dual linear control options and the mode handpiece type selected Posterior and Combined Domain Types available depend on the sub mode selection Fixed vacuum level or linear 0 mmHg to 20 mmHg by mmHg Phase Case vacuum maximum level 20 mmHg to 200 mmHg by 5 mmHg 200 mmHg to 600 mmHg by 10 mmHg Minimum of 10 mmHg for U S modes Linear vacuum minimum 0 mmHg to 20 mmHg by 1 mmHg Phase Case level 20 mmHg to 200 mmHg by 5 mmHg 200 mmHg to 600 mmHg by 10 mmHg Minimum of 10 mmHg for U S modes Region 2 minimum vacuum 0 mmHg to 20 mmHg by 1 mmHg Phase Case for aspiration control feature 20 mmHg to 200 mmHg by 5 mmHg 200 mmHg to 600 mmHg by 10 mmHg Foot control mapping for Linear Front Loaded Back Loaded Phase Case linear control 3 32 Operator s M
19. No Latex Caution Consult Accompanying Documents 110017276EN Rev B Preface EtO gas sterilized Gamma Irradiation Sterilized Do Not Reuse Do Not Re Sterilize Do Not Use If Damaged Transport Symbol See page 1 30 Operator s Manual Preface 5 Preface Always wear eye protection or face mask when installing or removing the lamp Warning Hot surface Electrostatic sensitive device Never touch the silica glass bulb of the lamp with bare hands X E N Q N Xenon jp Pe XENON MERCURY Xenon Mercury Preface 6 Operator s Manual 110017276EN Rev B Contents 1 2 1 2 2 2 3 2 4 2 5 2 6 2 7 2 8 2 9 2 10 2 11 2 12 2 13 2 14 2 3 1 3 2 3 3 3 4 3 9 3 6 3 3 8 3 4 1 4 2 4 3 4 4 4 5 4 6 4 7 4 8 Getting Started Components Shipped with the System 4 5 pon tritt hp io Ib D DIR D ee 1 2 Connections and Setup inner ne nu Rue be 1 2 System DESCHPION Aue enlarge pavo ee 1 5 Setting Up Your System EE 1 6 Starting a New Procedure ege EES seen aka 1 15 Using Your System in Surgery E 1 21 Concluding a Surgical Procedure edet nte era 1 23 ele UE 1 27 Power LE le EE 1 27 Moving Your System to Another Location nennen ene nere enne nne 1 28 System CompoHebls E 1 29 FootConttol EE 1 38 Ulumin tion Function 1 59 Multimedia Center MMC E e EE 1 62 User Interface Posterior amp Combined Domain In
20. Preset pressure may be set too low Increase air pressure setting to desired level System shutdown cassette Power supply cut off from the source or 1 Stop surgery and ejected and irrigation power cable is accidentally unplug from the remove handpiece from running into cassette wall the eye cartridge and handpiece 2 Close irrigation clamp to stop fluid flow into the cassette cartridge and handpiece 3 Replace test chamber to the handpiece that is connected to the tubing 4 Reboot system prime and tune handpiece when power supply resumes ensure to open irrigation clamp before starting to re prime and tune system Remote Control not Remote firmware not responding to key Corrective action Reset working with good or new inputs the device by removing the batteries batteries and waiting for at least one minute before re installing the batteries 110017276EN Rev B Operator s Manual 6 19 6 Troubleshooting 6 4 Troubleshooting the MMC When a problem appears with the MMC the first step in troubleshooting is to remove the MMC components from the video setup and then assure that the rest of the system is operating correctly Symptom Action Required Video display not centered on screen Check video monitor for overscan or underscan adjustments or edge off screen Is camera powered on Turn the MMC off If video is displayed the input and output cables to the MMC are reversed Check for video whe
21. See Chapter 5 for cleaning and sterilization requirements when surgery is completed Ultrasound Function Phacoemulsification refers to the process of ultrasonic disintegration of the lens using a vibrating needle operating at a frequency above the audible range in the anterior chamber of the eye 4 32 Operator s Manual 110017276EN Rev B 4 Detailed Reference Ultrasound Power The ultrasound display allows you to adjust maximum ultrasound power pulses per second PPS duty cycle DC pulse duration and pulse interval Both the current setting and the actual value are shown on the Surgical Screen display The status bar see page 2 74 visible at the top center of the surgical screen might display the average ultrasound power AVE actual phaco time APT and effective phaco time EPT depending on system settings The AVE display is internally calculated as the arithmetic average of all phaco power used since last reset The APT display indicates the time in minutes and seconds that phaco power has been energized since last reset The EPT is derived from multiplication of AVE and APT Use the Case More Screen see page 2 67 to reset the phaco timer and average The timer is also reset when you select Next Patient on the End of Case Screen Pulse Mode Ultrasound Pulse mode ultrasound power may be adjusted from 1 to 100 using the up down spin buttons Foot Control buttons or remote and 1 increments using the keypad Pulse outp
22. and duty cycle DC spin controls appear if the display option button is selected Vacuum The upper left section of the screen shows the maximum vacuum or vacuum limit setting in a spin control button with the current actual value shown below it Footpedal and Coagulation The current footpedal status is displayed in the middle of the bottom of the screen The current pitch region 1 2 or 3 is shown The Footpedal More Button brings up a More Settings Screen that allows you to change settings on the footpedal See page 2 61 for details on changing these settings If one of the Foot Control Buttons has been programmed to control coagulation a small Coagulation spin control will appear just to the left of the Foot Control display showing the current maximum power setting for the coagulation function Case Window At the top of the screen a status bar display shows the name of the surgeon currently working as well as the e current case number Selecting the Display Format Button repeatedly shows progressively more detail 2 74 Operator s Manual 110017276EN Rev B 2 User Interface Level 2 Display At Level 2 more detailed information is added to each display about the current value of each system In addition to the spin control buttons that are present in the Level 1 display the Level 2 display adds a test tube display and control see page 2 2 The current value of the function is displayed at the top of the tube and a
23. maintain retinal tissue At the requested c Yellow 88 setting this does level may be exceeded d Amber 10096 in less than 30 minutes with the Bausch Lomb focal light probe positioned 15 2 Distance from the retina mm from the retina LM28 Info 3 Light dispersing probes MultiMedia Center MMC Module Messages iD Type TextMessage Suggested Action s SG73 Please ensure that the multimedia center is plugged in and powered on MMCO1 Info The multimedia center was not detected SG74 Check that the multimedia center data cable is plugged in to both the system and the multimedia center The multimedia center software version SG02 Call your product service is not compatible with this software MMCO02 Info 3 2 representative A compatible software version The video overlay function is not version must be downloaded available The multimedia center has failed to SGO4 Call your produce serite MMC03 Info respond to a settings command The er ae representative if this problem persists settings have been re sent Remote Control Receiver Module Messages iD Type _ Text message Suggested action s The remote control receiver was not detected in the system Remote control SOU Call your product service ROROL Warning and display backlight control functions representative are not available The remote control receiver software EP d SG02 Call your product service v
24. which is the below the Footpedal status icon on the bottom of the Main Surgical Screen and Setup Screen In the posterior and combined domains the Foot Control More Settings Screen is displayed by selecting the More Settings Screen button Footpedal The footpedal itself located in the center of the Foot Control provides two axes of movement and thus allows simultaneous control of two system parameters Both controls are programmable with respect to function and control parameters In the pitch direction the footpedal will provide approximately 15 of up down movement In the yaw direction the center pedal will provide approximately 10 of travel from center in both the left and right directions however the center home position may be set to be offset approximately 5 in either direction as explained on page 1 56 When released the footpedal will return to the home up or center position The table on page 1 59 shows the possible combinations of control available The programmable detents provide tactile feedback to the pitch movement when it moves between different regions 1 54 Operator s Manual 110017276EN Rev B 1 Getting Started Single Region Pitch Control one detent position The pitch movement is programmed to provide linear control as a function of relative footpedal displacement e g 0 to 15 down corresponds to 0 to 100 output Examples of single region pitch control are the linear coagulation function and fixe
25. 2 77 Setup Screen showing I V Pole Control and Fill Control Selecting the fill button opens the pinch valves in the fluidics system for a fixed period of time This function is useful for filling surgical beakers without overflow A green ring around the button indicates that it is currently on You can select it to toggle to the other state Air Pressure If the Pressurized Infusion function is programmed in the surgeon file the upper right corner of the screen displays the current setting of air pressure when the pump is not running When the pump is switched on the same area will display the actual output pressure Below the setting display there is an on off button to control the air pump operation 110017276EN Rev B Operator s Manual 2 73 2 User Interface Ultrasound Coagulation or Vitrectomy The lower right corner displays either the Ultrasound Coagulation or Vitrectomy status depending on which mode is currently selected from the clock menu The current setting is shown in the large spin control with a green background for ultrasound yellow background for vitrectomy and purple background for coagulation The actual value is displayed in a small grey circle below the spin control When ultrasound is active an option list control appears in the lower right corner and selecting the small allows you to select from a list of preprogrammed ultrasound submodes If you select pulsed ultrasound the pulse per second PPS
26. 230 pounds 114 kg Recommended Tray Capacity 12 lbs 5 4 kg Standards Compliance The Stellaris PC Vision Enhancement System is designed to meet the requirements of IEC 60601 1 2005 3rd edition and all appropriate amendments collateral standards particular standards and country differences Equipment Classifications Type of Protection Against Electrical Shock Degree of Protection Against Electrical Shock Type BF Degree of Protection Against Water Ingress Electromagnetic Compatibility EMC The Stellaris PC Vision Enhancement System is a piece of medical equipment As such it requires special precautions regarding electromagnetic compatibility EMC It should be installed and put into service according to the EMC information provided in the tables below Portable and mobile RF communications equipment can potentially affect all electronic medical equipment including the Stellaris PC Vision Enhancement System Guidance on maintaining appropriate separation between communications equipment and the Stellaris PC Vision Enhancement System is provided in the tables below 8 2 Operator s Manual 110017276EN Rev B 8 Specifications Pi A complete line of accessories for the Stellaris PC Vision Enhancement System and other surgical instruments is available from Bausch amp Lomb Contact your Bausch amp Lomb sales representative or login to Storzeye com and visit the online store for detailed information The use of access
27. Aspiration pressure is fixed and pre programmed through the touch screen user interface Linear Extract Extraction is controlled via the center footpedal The extraction vacuum increases proportional to footpedal travel from the minimum programmed setting to the maximum programmed setting The minimum and maximum vacuum are set using the touch screen Fragmentation Posterior Only The Stellaris PC Vision Enhancement System Fragmentation function provides ultrasound emulsification and vacuum for lens removal from the posterior segment of the eye A Note During any ultrasonic procedure metal particles may result from inadvertent touching of the ultrasonic tip with a second instrument Another potential source of metal particles resulting 110017276EN Rev B Operator s Manual 4 27 4 Detailed Reference from any ultrasonic handpiece may be the result of ultrasonic energy causing micro abrasion of the ultrasonic tip Fragmentation modes The Stellaris PC Vision Enhancement System provides two Fragmentation modes with adjustable ultrasound power and vacuum control Refer to the table on page 3 33 for information on the available vacuum range and options on ultrasound modulations Detailed description of Ultrasound modulations such as Pulse Burst and Duty Cycle are provided in the Ultrasound Functions section of this chapter Linear Frag Linear Frag submode provides linear vacuum in footpedal region and fixed maximum vacuum a
28. Foot Control is connected to the system by either wired or wireless connections A WARNING Use only handpieces cables tube sets and accessories designated by Bausch Lomb for use with this system WARNING Manufacturers of cardiac pacemakers advise against use of bipolar cautery devices on patients with such implants When conducting surgery on such a patient a battery powered thermal cautery may be used or the manufacturer of the pacemaker should be consulted to determine appropriate steps to take in order to use the bipolar cautery function A WARNING Manufacturers of implantable defibrillators recommend that these devices be temporarily disabled when using bipolar cautery on patients with implants The surgeon should determine if the patient has such a device and consult the manufacturer for appropriate actions 110017276EN Rev B Operator s Manual 1 31 1 Getting Started User Interface Screen The User Interface Screen is the way the user communicates with the system See Chapter 2 for basic user interface controls Technical specifications can be found in Chapter 8 A typical interface setup screen is shown below Type t x GO i 4 ect D Ken Procedure en Beate Gasaalie Advance to Q Ca Surgery ye n Fr o and Turc Menu Cassatie Neen Tank Insert Cassette _ ld a Cong Cassetto om 21 M 9 wa Figure 1 19 Typical interface screen 1 32 Operator s Manual 110017276E
29. Interface ee x Se AVE 0 APT 0 00 00 EPT 0 00 00 TA K eca a BS EE Ae E E wes e y A 2 o E 8 er e e Figure 2 74 Large Video Anterior Surgery Screen 2 70 Operator s Manual 110017276EN Rev B 2 User Interface Figure 2 75 Small Video Anterior Surgery Screen 110017276EN Rev B Operator s Manual 2 71 2 User Interface IV Pole IV Pole e Preset y on Figure 2 76 IV Pole Control Display 140 TITTEN a 30 The upper right corner of the screen also displays the current setting for the IV Pole on the bottle as well as the preset value above the bottle You can use the up and down arrows to change the height and the IV Pole will automatically move up and down to match the setting The Preset value is a pre programmed value to which you can jump quickly simply by selecting it on the screen Different surgical modes may have different preset values You can change the preset value for the current session by opening the More Settings Screen see Figure 2 61 and selecting the Infusion Tab The On Off button controls the continuous irrigation function by opening or closing the irrigation pinch valve in the fluidics system If the irrigation control is turned off the function will still be managed by the Foot Control when the footpedal enters Region 1 irrigation will commence 2 72 Operator s Manual 110017276EN Rev B 2 User Interface Figure
30. Needle monitoring electrodes are not recommended In all cases monitoring systems incorporating high frequency current limiting devices are recommended Properly equipped monitors are usually identified as having electrosurgery interference suppression or ESIS options Table of Cables Cle tenth 110017276EN Rev B Operator s Manual 8 3 8 Specifications pate ten BL4394 Foot Control Power Cable 8 4 Operator s Manual 110017276EN Rev B 8 Specifications Guidance and Manufacturer s declaration electromagnetic emissions The Stellaris PC Vision Enhancement System is intended for use in the electromagnetic environment specified below The customer or the user should ensure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance The Stellaris PC Vision Enhancement System must emit RF emissions SE Group 2 electromagnetic energy in order to perform its intended CISPR 11 function Nearby electronic equipment may be affected RF emissions Class A CISPR 11 The Stellaris PC Vision Enhancement System is Harmonic Emissions Class A suitable for use in all establishments other than domestic IEC61000 3 2 establishments and those directly connected to the public Voltage fluctuations low voltage power supply network that supplies buildings flicker emissions Complies used for domestic purposes IEC 611000 3 3 110017276EN Rev B O
31. Overlay tab To add a new technique to the list select Add then select any surgeon from the list that appears and the techniques defined for that surgeon will appear Select a technique and select Confirm to add that technique the original list To change the settings for a particular technique select the technique then select Customize The Customize Technique Screen will appear with tabs for Profile Phases Exceptions Foot Control Fluidics A V and Illuminators Various parameters may be adjusted through these tabs as described below 110017276EN Rev B Operator s Manual 3 5 3 Customizing Your System Figure 3 5 Customize Technique Screen Profile Tab Technique Name Patient Pathology e Phases Tab Each technique may include up to eight phases The Phases Tab shows the name of the phase and the mode for that phase Phases can be added deleted or re ordered They may also be customized as described below e Exceptions Tab Each technique may include up to 8 exceptions Exceptions can be added deleted or re ordered They may also be customized as described below e Foot Control Tab Foot Control Button 4 standard sets plus custom settings enable disable next ultrasound modulation on yaw reflux on yaw reflux type fixed coag power linear coag setup e Fluidics Tab Vacuum response 1 Fastest to 5 Slowest venting method fluid air F AX mmHg air port front back Infusion Type IV Pole pressurize
32. PC Vision Enhancement System Ethernet Cable optional The Ethernet cable connection only applies to a Stellaris PC Vision Enhancement System with TruLink Customer Support Network enabled when you intend to upload system information to the Bausch Lomb Global Service Support server No Ethernet cable is supplied with the system If you plan to use the TruLink Customer Support Network connect an Ethernet cable from the back of the Stellaris PC Vision Enhancement System to the wall network port before powering up the system and disconnect it after the system is powered down When the Ethernet cable is not in use install the attached protective cap into the open socket Compressed Air Connection Connect the external air hose to the rear of the system as shown and then to an appropriate air source 1 4 Operator s Manual 110017276EN Rev B 1 Getting Started Mr SSeS Figure 1 2 Back bottom of system e Note The system requires filtered medical grade air or medical grade nitrogen at 72 5 to 100 psig 500 kPa to 690 kPa or 5 0 to 6 9 bar and a flow rate of 2 25 SCFM 63 7 SLPM 1 3 System Description The Stellaris PC Vision Enhancement System has a modular design which enables it to be easily upgraded to take advantage of advances in technology The system consists of a main housing unit which contains a user interface screen and the surgical modules and a Foot Control infrared remote control for anterio
33. Position 7 only 110017276EN Rev B Operator s Manual 1 45 1 Getting Started Wireless Foot Control Operations System Setup e Note The out of factory Wireless System Setup is Disabled Software upgrade will reset the Wireless System Setup to Disabled also To setup wireless operation follow steps below Step 1 Select Programming from Setup or Select Surgeon screens Step 2 Select System Setup from the programming screen as shown below Figure 1 31 Programming Screen Step 3 Select Foot Control tab from the System Setup screen Arrow in image below 1 46 Operator s Manual 110017276EN Rev B 1 Getting Started LESSEE eee Figure 1 32 System Setup Screen Step 4 Select Wireless Enabled or Disabled to configure foot control connection mode Circled in image above e Note The system setup is for enabling wireless functionality it does not affect the wired functionality The wired option is always available and active when connected Note The system will disable wireless operation once it detects a loss of wireless connection at the setup and surgery screens Changing the battery at the setup and surgery screens will also disable the wireless system setup 110017276EN Rev B Operator s Manual 1 47 1 Getting Started Foot Control Status and Wireless Signal Strength Meter Display The status of foot control operation is represented by icons display at the
34. Rev A 4090500 015000627 Rev A 4090600 Xenon Lamp Label Xenon Mercury Lamp Label 8 20 Operator s Manual 110017276EN Rev B 9 Glossary Glossary AFI Air Forced Infusion Refers to the use of pressurized air to create necessary pressure for infusion of fluid into the eye The Stellaris PC Vision Enhancement System AFI requires the use of the bottle spike with metal tube to supply air pressure and venting A V Audio Visual settings that include screen display tone volume and video display Burst Mode Ultrasound An intermittent ultrasound modulation with ultrasound duration and rest time controlled linearly with foot control Ultrasound power is fixed Case Settings relating to instrument gauge needle type cataract hardness or pathology Detent Tactile feedback in Stellaris PC Vision Enhancement System foot control to alert user when foot pedal is moved from one region to another Domain System functionality and set up that provides a group of functions related to either anterior posterior or combined surgery Dual Linear Foot control feature that controls various surgical function with two axes of foot pedal movement Both axes allow linear control of surgical functions relative to the pitch and yaw movement of the foot pedal Elevated Infusion Refers to temporary use of higher than normal infusion pressure during posterior surgery In Stellaris PC Vision Enhancement System elevated infusion is
35. System aspiration port Failure to follow this procedure may result in serious and permanent patient injury Posterior Vitrectomy Setup and Use 1 Connect the compressed air source to the connector on the lower rear of the system Turn the power on and wait until the screen displays the Foot Control or other system messages Acknowledge and close all messages Je Jp a To operate the Foot Control wirelessly press any button on the Foot Control and wait until the right light turns solid green This indicates that wireless communication has been established 5 The screen will display Select Procedure If your system is programmed to default to either the Anterior Domain or the Posterior Combined Domain the Select Procedure Screen will not appear and the system will move directly to the Select Surgeon Screen as shown in Figure 1 7 110017276EN Rev B Operator s Manual 4 7 4 Detailed Reference Select Posterior Segment the screen will transition to Select Surgeon Skip this step if the system is already displaying the Select Surgeon screen 6 Select Surgeon s Name and select Confirm to transition to the Insert Cassette screen Open the posterior surgical pack with the following steps a Hold the bottom of the tray with left hand and the thumb placed in the thumb notch Circulating Nurse Tear open the Tyvek seal toward the body Circulating Nurse Pour contents onto sterile surface Circulating Nurse Id
36. U S 8 15 S Screen Layout 2 34 2 67 Settings Managing 3 3 Settings More 2 20 2 56 2 66 Setup Coagulation Fixed 4 47 Linear 4 48 Phacoemulsification 4 37 Specifications Cables 8 3 Coagulation 8 12 Computer Unit 8 8 EMI 8 4 8 5 Foot Control 8 9 I A Vitrectomy 8 16 IV Pole 8 11 MMC 8 2 Physical 8 2 Remote Control 8 10 Ultrasound 8 14 Vacuum Fluidics 8 16 Spin Button 2 40 Sterilization Bipolar Accessories 5 2 VA Handpiece 5 5 Phacoemulsification Needle 5 11 Surgeon Preference File Create 3 14 T Technical Assistance 7 1 Test Tube Control 2 2 2 42 Time Format 3 18 Time Setting 3 18 Troubleshooting 6 1 TruLink Remote Access 1 37 3 24 110017276EN Rev B Index Operator s Manual Index U Ultrasound Handpiece Cleaning For U K 5 11 Module Specifications 8 15 Needle Cleaning 5 10 Sterilization 5 10 Operation Burst 4 33 4 36 Linear 4 35 Phacoemulsification Module Description 1 33 Specifications 8 14 Operation Burst 4 33 4 36 Linear 4 35 Power 4 33 Ultrasound More Settings 2 20 2 56 Unpacking 1 2 Unplanned Vitrectomy Setup Vacuum Fluidics 4 41 V Vacuum Fluidics Unplanned Vitrectomy Setup 4 41 Vacuum Limit Setting 2 73 Vacuum Response 4 31 VAFI 1 17 Vented Air Forced Infusion 1 17 Venting 4 30 Video Overlay Tab 2 30 2 65 Viscoelastic Removal Operation 4 30 Vitrectomy More 2 59 Voice Confirmation 2 28 2 63 Y Yaw 1 51 Aspiration 1 55 Operator s
37. UP DOWN buttons are used to move the arrow and select options in the Prime and Tune window Pressing the Enter button on the remote control activates the selected function e Note The batteries should be removed from the remote control if the system is to be idle for more than 30 days Note It is your responsibility to dispose of batteries in a safe and environmentally responsible manner in accordance with local regulations 1 38 Operator s Manual 110017276EN Rev B 1 Getting Started TruLink Customer Support Network Remote Access optional The TruLink Customer Support Network feature improves system reliability by supporting remote diagnostics and performance analysis System performance data but no patient data is collected by the Stellaris PC Vision Enhancement System throughout the surgical day Upon system shut down that information can be sent to Bausch Lomb secure servers through an encrypted point to point connection This allows Bausch Lomb to analyze system performance help you remotely where this service is available and proactively service the system Surgeon preference files can also be transmitted to provide a secure off site backup The Ethernet cable that is used to transfer the data can be permanently connected to the Stellaris PC Vision Enhancement System or it can be connected at the end of each surgical day just before shutting down and then disconnected to move or store the Stel
38. USER INFORMATION MANUAL IN NO EVENT WILL BAUSCH LOMB BE LIABLE FOR ANY INCIDENTAL INDIRECT OR CONSEQUENTIAL DAMAGES IN CONNECTION WITH THE PURCHASE OR USE OF ITS PRODUCTS 110017276EN Rev B Operator s Manual 7 11 7 Service and Warranty Post Warranty Information When warranty coverage expires Bausch Lomb is pleased to provide Service Agreements that provide the assurance customers are seeking in managing equipment performance and budgeted service expense Contact your local Bausch Lomb sales representative for additional details and current service agreement programs Caution Bausch Lomb is the only authorized service organization for Bausch Lomb ultrasonic handpieces Bausch Lomb does not recommend having your ultrasonic handpiece repaired by third party service organizations and assumes no responsibility or liability for the function safety or operation of any handpiece repaired or serviced by anyone other than the Bausch Lomb service organization Return Policy Bausch Lomb will within the return period as specified on your invoice from the date of invoice accept return of this product for a full refund less any handling and shipping charges incurred by Bausch Lomb Customer must call their local Bausch Lomb customer service representative to request a Return Good Authorization prior to expiration of the return period It is the Customer s responsibility to properly pack all items being returned A rest
39. action s SG88 Go to Infusion More screen or UICO1 Info IV pole height range is X to Y cm programming function to reset max IV Pole Height Phase Mode change not allowed while SG77 Change Phase Mode while surgical UICO3 Info f surgical functions are in use functions are not in use SG78 Power down the system and then Initialization of surgical system failed restart the system dd Wanne Surgical mode not available SG04 Call your product service representative if this problem persists SOU The system database is corrupt The The system database is corrupt Surgical UICO5 Warning i system will shutdown upon confirmation of mode is not available error Geer Pe SG84 Press Yes for a 0 cassette or press UIC06 Info type Do you want to enter the matching No to eject the cassette procedure type assette type does not match procedure r UICO7 Info Yp P SG85 Please insert a posterior cassette 6 10 Operator s Manual 110017276EN Rev B B Incorrect ultrasound handpiece connected 6 Troubleshooting SG86 Please plug in a Phaco Frag handpiece or try another ultrasound handpiece SG04 Call your product service representative if this problem persists iD pe TextMessage Suggested action s UICO9 Vitrectomy cutter testing is in progress Bee ene enemy cauer testing is in progress Ultrasound Module Messages iD pe Jeu Message Suggested action s Surgeon File Is Not Usable d
40. and bipolar accessories for the Millennium Microsurgical System and Stellaris are compatible and could be used with the Stellaris PC Vision Enhancement System Available Accessories and Packs The packs listed below can be used with the Stellaris PC Vision Enhancement System A complete list of accessories including approved needles and sleeves and packs is available from your sales representative upon request 110017276EN Rev B Operator s Manual 6 21 6 Troubleshooting Stellaris PC System and Module List System BL1333 Stellaris PC Posterior System System BL1433 Stellaris PC Combined System Module BL2111 Remote Control Anterior Module Module BL2213 Vacuum Fluidic Module Stellaris PC Module BL2270 Posterior module Module BL2282 Compressor C module Stellaris PC BL2300 Multimedia Center Module Anterior Accessories and Packs I A 0 4 Tip Curved Silicone Sleeve 20 Gauge Aspirating Cannula BL3163 V A 0 4 Tip Angled 45 Deg Silicone Sleeve 20 Gauge Aspirating Cannula BL3164 V A 0 4 Tip Straight Metal Outer Cannula 17 5 Gauge BL3165 V A 0 4 Tip Curve Metal Outer Cannula 17 5 Gauge BL3166 VA 0 4 Tip Angled 45 Deg Metal Outer Cannula 17 5 Gauge BL3170 Ultrasound Phaco Handpiece BL3379 Stellaris Ultrasound Handpiece Tray DP9731 VA 0 3 Tip Straight Silicone Sleeve DP9733 V A 0 3 Tip Angled 45 Deg Silicone Sleeve DP9739 Softip VA 0 3 Straight Silicone Sleeve 20 Gauge Asp
41. and environmental information A Note Preventive scheduled maintenance is recommended once a year to insure that the Stellaris PC Vision Enhancement System meets its optimum performance reliability and safety standards set by the manufacturer The maintenance shall be done by a Bausch Lomb certified individual only A Note Other than main fuses and lamps this system contains no parts that are serviceable by the user All maintenance shall be done by a Bausch Lomb certified individual only 7 1 Service Information Technical Assistance Assistance for Stellaris PC Vision Enhancement System is available from Global Product Support as follows Bausch amp Lomb Incorporated 3365 Tree Court Industrial Blvd St Louis Missouri 63122 U S A Attention Global Product Support Department http www bausch com en_US ecp age surg_prod_support aspx e For product support within the U S A call the 24 hour telephone line 1 800 338 2020 or fax 636 226 3070 e For product support from outside the U S A either call 1 636 226 3535 send a fax to 1 636 226 3070 or contact your local Bausch Lomb Product Support Representative listing of local offices starts on page 7 2 Please organize your material before calling or writing for technical support Please have the following information ready e Customer account number Name of function handpiece etc that needs service e Model number REF and serial number SN of
42. and wait until the right light turns solid green indicting wireless communication has been established 3 Select Surgeon s Name and select Confirm 110017276EN Rev B Operator s Manual 4 37 4 Detailed Reference 4 10 12 13 14 Open disposable package and insert the cassette all the way in and hold until it is automatically captured by the system The cassette housing backlight will stop blinking and remain on when the system captures the cassette The vacuum test starts automatically After vacuum test completes the Setup Screen will appear with Prime and Tune as the highlighted function Spike the BSS bottle and hang it at the desired bottle height Additional step if pressurized infusion is used Connect the Air Tubing Line to the vent port at the bottle spike and the other end with air filter to the Stellaris PC Vision Enhancement System air output connector Switch on the air pump from the system setup screen the control is at the upper right hand of the screen The output connector will remain lit when it is at commanded pressure and blink on and off when it is not at the commanded pressure Connect tubing to ultrasound handpiece Select Show Me Steps for animated setup guide if necessary Plug the handpiece connector to the machine second connector from the top on the left side Thread and firmly secure the ultrasound needle onto the ultrasound handpiece using a needle wrench Slide the irrigation sleeve o
43. be accessed from the main screens when needed 110017276EN Rev B Operator s Manual 9 3 9 Glossary Patient Eye Level The vertical distance from patient eye level to the aspiration ports of the Stellaris PC Vision Enhancement System system Stellaris PC system has a feature to adjust patent eye level offset if the patient eye level is not at the same level as the aspiration port The offset range is 15 cm to 15 cm Phase See Mode Pitch Up and down movement of foot pedal Pressurized Infusion Similar to AFI pressurized air is used to drive irrigation into the eye for anterior surgery Programming Level Describes Stellaris PC Vision Enhancement System system settings hierarchy The hierarchy is System Surgeon Technique Mode Phase Sub mode and Case levels Pulse Mode Ultrasound An intermittent ultrasound pulse modulation with fixed rate Ultrasound power is linearly controlled with the foot control Reflux Momentary reversal of fluid flow towards the handpiece Reflux pressure is generated from the irrigation bottle or mechanical plunger Rise Time Speed with which system generates commanded ultrasound level Stellaris PC Vision Enhancement System has ultrasound rise times 1 and 2 Rise time 1 is traditional power control where ultrasound is ramped up to demanded level instantaneously Rise time 2 ramps up phaco power gradually Sub mode Different foot control options or settings within a surgical m
44. bulb The lower illuminator bulb is at end of LM25 fife Lamp vall bedisdbledat tumed of SG95 Replace the lower illuminator bulb The illuminator temperature is too high s LM26 Warning The illuminators may be turned off SOPA dips product ae Kee representative if this problem persists within 2 5 minutes The time to reach the exposure guidelines Note that the level of light output being will vary with requested should be used with awareness of exposure time and proximity to the 1 Filter selection Value reached within 30 retina minutes with the following settings Limiting exposure to less than a a White 6096 LME TUBIS guidelines value of 10 J cm2 helps b Green 68 maintain retinal tissue At the requested c Yellow 88 setting this does level may be exceeded d Amber 10096 in less than 30 minutes with the Bausch Lomb focal light probe positioned 15 2 Distance from the retina mm from the retina 3 Light dispersing probes 6 8 Operator s Manual 110017276EN Rev B 6 Troubleshooting iD Type TextMessage Suggested action s The time to reach the exposure guidelines Note that the level of light output being will vary with requested should be used with awareness of exposure time and proximity to the 1 Filter selection Value reached within 30 retina minutes with the following settings Limiting exposure to less than a a White 6096 guidelines value of 10 J cm2 helps b Green 6896
45. can only be achieved when the equipment is connected to an equivalent receptacle marked Hospital Only or Hospital Grade 110017276EN Rev B Operator s Manual 1 1 1 Getting Started A WARNING A Note 1 1 Components Shipped with the System protective earth To avoid risk of electric shock this equipment must only be connected to a supply mains with Preventative scheduled maintenance is recommended once a year to insure that the Stellaris PC Vision Enhancement System meets it optimum performance reliability and safety standards set by the manufacturer The maintenance shall be done by a Bausch Lomb certified individual only Before unpacking inspect all packages for damage Report any damage from shipping to the carrier Before discarding packaging material assure all parts are accounted for Smaller parts may be attached to packing materials Standard components shipped with the system include 1 2 System Main Console Foot Control with Battery Foot Control Wall Charger Extra Foot Control Battery Foot Control Backup cable Operator s Manual CD System Power Cord Mayo Tray Foot Control Battery Charging Cradle Air Hose Zero Level Bottle Hanger Connections and Setup A WARNING For optimum aspiration and reflux performance the patient s eye must be at the same level as the Stellaris PC Vision Enhancement System aspiration port If this is not possible use the 1 2
46. damaged handpiece may result in serious permanent patient injury A WARNING Do not cold sterilize the instrument The sterilizing solution may not be flushed out prior to surgery and could be flushed into the eye resulting in serious eye injury CAUTION Allow 20 minutes after sterilization for the handpiece and cord to cool before using them again The handpiece connector must be completely dry before it is connected it to equipment Note To maintain flexibility and prevent cable damage wind the cord only loosely if needed and do not store it coiled with a less than 6 diameter 5 10 Operator s Manual 110017276EN Rev B 5 Cleaning and Sterilization Requirements E The handpiece needle and irrigation sleeve must be sterilized before use With the exception of flash sterilization the items may be wrapped in a surgical towel CSR wrap or equivalent Except for users in the United Kingdom the minimum requirements for sterilization are ea Note Standard Gravity Steam Sterilization Wrapped for 30 minutes at 121 C 104 8 kPa 1 048 bar 250 F 15 2 psi Flash Sterilization Unwrapped but covered for 10 minutes at 132 C 186 8 kPa 1 868 bar 270 F 27 1 psi High Vacuum Pre vacuum Sterilization Wrapped for 3 minutes at 134 C 206 8 kPa 2 068 bar 274 F 30 0 psi For users in the United Kingdom please refer to page 5 11 for special cleaning and sterilization instructions before proceeding Refer to ANS
47. defined as pressure above 60 mmHg for air infusion or above 81 cm H O for fluid infusion 110017276EN Rev B Operator s Manual 9 1 9 Glossary End Case Describes the conclusion of surgery A touch screen button in the Stellaris PC Vision Enhancement System graphical user interface would conclude a surgery and transition system to the End of Case screen Extrude A surgical mode that aspirates fluid out of the eye Selecting the Extrude mode activates vacuum from the left aspiration line to be used during the procedure Fluid Air Exchange F AX A surgical procedure to replace fluid in the eye with atmospheric air The process involves injecting air with a specific pressure and an extrusion cannula to evacuate the fluid Foot Control Mapping The correspondence between foot pedal linear movement and surgical function activation Foot control mapping options are linear 1 front loaded 2 back loaded 3 or reverse linear 4 X Foot Pedal movement from home position and Y Surgical function energy level see diagram below 9 2 Operator s Manual 110017276EN Rev B 9 Glossary Foot Control Switches Four active pressable areas surrounding the Stellaris PC Vision Enhancement System foot pedal The two upper switches are referred to as toe switches and the two lower switches are referred to as heel switches Gravity Infusion Infusion derived from pressure created by hanging the fluid bottle at a certain height above
48. displayed The pop up window will provide the user with a choice of options for proceeding Nothing else may be done while a pop up window is displayed Messages and suggested corrective actions are shown in the following tables 110017276EN Rev B Operator s Manual 6 3 6 Troubleshooting Power Supply Module Messages oar eg eee rain Suggested Action s DEn 02 The power supply was not detected in the SGO1 Call your product service system representative The power supply software version is not SG02 Call your product service BPSO3 Warning compatible with this software version representative A compatible software Surgical mode is not available version must be downloaded 2 Me power supply Pan pop SG04 Call your product service BPS04 Warning to a settings command The module jemesentaiveit this problenm potist settings have been re sent to the module BPSOS Warning The power supply has reset The module SG04 Call your product service settings have been re sent to the module representative if this problem persists SG67 Confirm that the bottom and lower The power module is at an over rear areas of the system are not blocked BPSO8 Warning temperature condition System shutdown from free air flow is imminent SG04 Call your product service representative if this problem persists Compressor Module Messages iD Type TextMessage suggested action s The compressor module was not detected CPX0
49. door A Note Following system shut down wait a minimum of 15 seconds before restarting the system The system is fully shut down after the front panel power button light changes from dim to bright Figure 1 26 Battery compartment with recess arrows to facilitate battery replacement e Note Be sure to securely close battery door Note A battery must be installed in the Foot Control at all times while operating either wired or wireless to insure proper operation The first time a Foot Control is used it must be connected via the back up cable to set the configuration Once this is set the Foot Control will only communicate wirelessly with that specific system To begin wireless operation make sure the Stellaris PC Vision Enhancement System is on then press any Foot Control Button and wait communication to be established which may take up to 10 seconds The ready light identified by the symbol below will turn solid green when the Foot Control is communicating wirelessly with the Stellaris PC Vision Enhancement System During operation when system is not detecting foot control wireless connection the system will disable wireless operation This happens when the system is 1 42 Operator s Manual 110017276EN Rev B 1 Getting Started in setup and surgery screens To resume wireless operation refer to the Foot Control Wireless System setup section 1 C LED Symbol for Ready on Foot Control When not in use
50. facility Bausch Lomb personnel will provide on site training to users who will operate the system The training includes system startup accessories and connections priming and settings adjustment consistent with the instructions provided in this user manual Subsequent training is provided for new staff when the system is upgraded or as requested by the facility Manual Concept Bausch Lomb designs manuals to give you the information you need when you need it without having to search for it This manual is organized so that in the first chapter you will find enough information to quickly get up and running and get answers to general questions about the Stellaris PC Vision Enhancement System We have included plenty of pictures so you can grasp concepts quickly Be sure to read Chapter 2 to become familiar with the Graphical User Interface and the Foot Control These are your connections to operate the system Chapter 3 describes information on how to customize the system to suit your particular needs Chapter 4 has detailed information about each function and feature how to set up the function and its associated disposables and how to interact with each function Chapter 5 provides cleaning and sterilization information These chapters are meant to serve as a reference to questions of a more technical nature Chapter 6 through Chapter 8 contain information that you may rarely need such as unpacking installing modules system check out me
51. is activated Serious patient injury may occur This features allows Bausch Lomb technicians to remotely access your system to diagnose problems and provide updates To manage the secure point to point connection between your system and Bausch Lomb select Remote Service from the Main Programming Screen and a new screen will appear through which you can monitor and initiate remote service on your system 3 24 Operator s Manual 110017276EN Rev B 3 Customizing Your System H ne a M T Figure 3 21 TruLink Customer Support Network Ensure that the Ethernet cable is connected to the Stellaris amp PC Vision Enhancement System and to the designated hospital network port Confirm that the system is not being used for surgery and select Initiate TruLink Connection e Note If you have the optional MMC system the Ethernet cable should be connected to the MMC then the MMC connected to the designated network hospital Ethernet port 110017276EN Rev B Operator s Manual 3 25 3 Customizing Your System ae as e Exit Programming Remote Service Figure 3 22 TruLink Customer Support Network Activated Screen The system will then be controlled by the remote technician When the remote technician is finished your Stellaris PC Vision Enhancement System will be shut down You may then restart the system A Note Off the shelf Ethernet cables may be used with the Stellaris PC Vision Enh
52. lower portion of the screen above the foot pedal activation status indicator Wired connectivity is represented with a cable icon and the wireless connectivity is indicated with a signal strength meter icon See table below Display Type Foot Control Setup Status Action Wired or Wireless System detecting wired Foot Control Wired Wireless System NOT detecting disabled wired connection Possible cause Foot Control cable not connected Wireless System NOT detecting wireless connection signal Possible cause 1 Foot Control wireless function has not been activated 2 Wireless connectivity not functioning due to battery issue 1 48 Operator s Manual No action required Check Foot Control cable connection If Wireless System Setup is on enabled wireless connection will be activated momentarily when system detects loss of wired connection The wireless signal strength icon will be displayed indicating system is now in wireless operation 1 Initiate wireless Foot Control connectivity by pressing one of the foot control buttons momentarily the left LED will light up 2 Check battery if Foot Control wireless function not established after Step 1 110017276EN Rev B 1 Getting Started Display Type Foot Control Setup Status Action Wireless System detecting No action required Excellent signal strength Wireless System detecting Good No action required signal strength Wir
53. of priming cycle The system will transition to Surgical screen Inspect the infusion line to ensure it is free of air bubbles If there are bubbles in the infusion line toggle Irrigation On from the screen and tap the line to purge if of the air bubbles To turn irrigation off use the tubing clamp or toggle Irrigation Off from the screen A Note Make sure to remove vitrectomy cutter by pulling it away from the priming cup without allowing the cutter needle to touch the priming tray Illumination Function Posterior Combined Domain A WARNING Care should be taken to avoid concentrating the illumination output on a small area of the retina for unnecessarily prolonged periods of time due to the potential for phototoxicity and serious permanent injury CAUTION Do not use lamps in damp locations in areas of high humidity or if condensation is likely to have formed for example immediately after moving from a cold location to a warm location CAUTION Do not block air vents A Note The surgeon should use the minimum illumination necessary to undertake the desired procedure Fiber optic illumination for intraocular viewing is accomplished with the Stellaris PC Vision Enhancement System The system contains two individually controlled light outputs each with its own lamp The standard configuration is a xenon lamp in the lower position Lamp 1 and xenon mercury lamp in the upper position Lamp 2 but can be configured with ei
54. on the right and the door should then lift off Figure 4 9 System side with lamp access door open Identify the lamp that requires replacement lower lamp Lamp 1 upper lamp Lamp 2 Undo the two lamp fasteners by turning the two thumbscrews counter clockwise Operator s Manual 4 15 4 Detailed Reference 5 Carefully pull the lamp housing from the unit and dispose of according to applicable regulations A Note A spent lamp that contains mercury must be recycled by an approved recycling collection facility in accordance with applicable domestic and international environmental laws and directives 6 Ifthe bulb is shattered and glass fragments are found contact B amp L service to remove them to prevent damage to the unit Figure 4 10 Side of the unit with lamps removed with lamp location and orientation shown 7 DON T TOUCH THE LENS LAMP CONNECTORS OR OTHER PARTS INSIDE THE SYSTEM 8 Open the packaging for the replacement lamp holding only the metal housing BEING CAREFUL NOT TO TOUCH ANY PART OF THE GLASS BULB OR CIRCUIT BOARD 4 16 Operator s Manual 110017276EN Rev B 4 Detailed Reference Figure 4 11 Lamp Housing Exterior 110017276EN Rev B Operator s Manual 4 17 4 Detailed Reference Figure 4 12 Lamp Housing Interior 9 Align the replacement lamp housing with the hole taking care to align the connectors on the top right and bottom left corners 10 Push the
55. power decrease U S power increase U S pulse rate duration decrease U S pulse rate duration increase U S duty cycle interval decrease U S duty cycle interval increase coagulation power decrease coagulation power increase vitrectomy cut rate decrease vitrectomy cut rate 3 30 Operator s Manual 110017276EN Rev B 3 Customizing Your System Iac H eee Posterior and unassigned next phase Combined Domains previous phase next U S modulation submode confirm settings infusion on off elevated infusion on off reflux fixed coagulation F AX on off vitrectomy cutting on off increase vacuum decrease vacuum increase infusion pressure decrease infusion pressure increase F AX pressure decrease F AX pressure increase U S power decrease U S power increase U S power increase U S PPS duration decrease U S PPS duration increase U S DC interval decrease U S DC interval increase coagulation power decrease coagulation power increase vitrectomy cut rate decrease vitrectomy cut rate increase viscous fluid pressure decrease viscous fluid pressure increase lower illuminator power decrease lower illuminator power lower illuminator on off increase upper illuminator power decrease upper illuminator power upper illuminator on off next illuminator filter 110017276EN Rev B Operator s Manual 3 31 3 Customizing Your System en Fluidics Parameter Options Ranges Step ze Standard MicroFlow
56. pressurize the BSS bottle The pressure generated would force BSS into the eye to maintain a preset intraocular pressure IOP The air pressure is generated by a compressor in the system and air is infused into the bottle through air tubing The use of Pressurized Infusion function would replace the gravity infusion that depends on bottle height The preset air pressure may be adjusted from the system screen display Pressurized Infusion is an optional function of the Stellaris PC Vision Enhancement System The function could be built into the system according to the customer order or the function could be added into existing field systems with an upgrade Enable Pressurized Infusion Function If system is installed with Pressurized Infusion software the function could be enabled from surgeon file programming or surgical More Screen To enable Pressurized Infusion Function from surgical More Screen Ensure surgical screen Format 2 is displayed Select fluidic More Screen button A double arrow up button below the vacuum preset display Select Infusion Tab of the pop up screen Bo A m Select Infusion Pressurize Display to Enabled See diagram below 110017276EN Rev B Operator s Manual 4 43 4 Detailed Reference Figure 4 26 More Settings Screen Infusion Tab Anterior 4 44 Operator s Manual 110017276EN Rev B 4 Detailed Reference Figure 4 27 More Settings Screen Infusion Tab Combined 5 S
57. primed this button will become Tune U S which will activate a shorter cycle of aspiration and tuning Ultrasound handpiece Select the Prime Tune U S button to initiate priming of the irrigation and left aspiration line followed by tuning of the ultrasound handpiece and a vacuum test During this process the IV bottle will be raised to 100 cm or the system will use a pressure of 73 mmHg if AFI is used The irrigation line and the aspiration line need to be connected to the ultrasound handpiece with the test chamber attached to the tip of the ultrasound handpiece After the line has been primed this button will change to Tune U S which will activate a shorter cycle of aspiration and tuning without the vacuum test Select the Prime Aux button to activate aspiration to fill the left aspiration line with BSS After the line has been primed subsequent priming cycles will be slightly shorter For Anterior Domain Select the Prime and Tune button from the Prime and Tune Screen to initiate priming of the irrigation and left aspiration line followed by tuning of the ultrasound handpiece and a vacuum test During this process the IV bottle will be raised to 100 cm or the system will use a pressure of 73 mmHg if AFI is used The irrigation line and the aspiration line need to be connected to the ultrasound handpiece with the test chamber attached to the tip of the ultrasound handpiece After the line has been primed this button will change to Tune On
58. priming cycles will be slightly shorter 110017276EN Rev B Operator s Manual 1 19 1 Getting Started For Combined Domain Select the Easy Prime button from the Prime and Tune screen to fill the left and right tubing with BSS solution and then perform a test of the pneumatic cutter During this process the gravity feed infusion I V pole will raise to 100 cm or lower if maximum ceiling height is set lower than 100 cm for the anterior In the posterior combined domains I V pole will raise to the maximum ceiling height programmed for the system With the air pressured infusion the pressure will raise to 73 mmHg for anterior domain and 103 mmHg for posterior combined domains Select the Prime Test Vit button to activate the vacuum on right side aspiration line and test the pneumatic vitrectomy function The handpiece tip must be submerged in BSS during this process After the line has been primed this button will become Test Vit which will activate the cutter test without aspiration The operation of the Prime Tune U S button differs depending on which ultrasound handpiece is connected to the system Fragmentation Handpiece Select the Prime Tune U S button to activate aspiration on the left line and tune the fragmentation handpiece The electrical connector on the fragmentation handpiece must be inserted into the Stellaris PC Vision Enhancement System and the tip submerged in BSS before this option is selected After the line has been
59. running tap water for fifteen seconds rotating the handpiece to expose all surfaces to the flowing water B Wipe the handpiece using a soft cloth moistened with a mild soap and water solution Avoid excessive quantities of solution around the electrical connector Remove all traces of the solution with a cloth dampened with clean water The surfaces should then be dried with a lint free cloth e Note For users in the United Kingdom please refer to page 5 11 for special cleaning and sterilization instructions before proceeding 5 6 Operator s Manual 110017276EN Rev B 5 Cleaning and Sterilization Requirements Figure 5 3 Ultrasound Handpiece and Needle 1 Needle Sleeve 2 Needle 3 Irrigation Port 4 Aspiration Port 5 Power Cord Figure 5 4 Fragmentation Needle and Handpiece 1 Needle 2 Frag handpiece 3 Aspiration port 4 Power cord A Use only warm 30 C to 40 C or 85 F to 105 F distilled or deionized water to flush the CAUTION handpiece Note You may use filtered compressed medical grade air medical grade nitrogen to blow out the tubing The pressure should not exceed 29 psi 200 kPa 2 bar C Flush the irrigation lumen as follows see Figure 5 5 below 1 Place the end of the syringe into a container of warm 30 C to 40 C or 85 F to 105 F distilled or deionized water and fill the syringe to the 50 cc ml mark 2 Connect the end of the syringe to the infusion line on the ul
60. slider ring on the tube can be used to change the setting Figure 2 78 Main Surgical Screen display level 2 110017276EN Rev B Operator s Manual 2 75 2 User Interface j 2 8 Customizing Your System Settings The Stellaris PC Vision Enhancement System has a programming interface through which you can program the system for your own preferred operating configuration and instrument parameters The programming screens are organized as shown in the following figure Im ase gt s n ser uoisnju UinnoeA ase ase smar s n 5e05 ISIA m uolsnju UnnaeA ouo 1004 lyoid HS aseud aseud aseud aseud aseud aseud aseud aseud I I NN s oyeuwnj soipini4 103005 1004 suonda x3 saseyd 9 UoJd anb uy gt aL anb uy gt aL anbiuypay anbiuyray nbjuyp nbjuyp nbjuyp Kean api AN SPINA 101005 1004 sanb uysaL ao uoa ns uoabins uoa ns uoa ns uoabins uoabins QI waysks awl eq aa aiotson dnmyeg Sea azIWO sND dnies uieis s 92IAJ9S ajoway Jepuaje wasks sbunies uoabins uoneinbyuo waysks Burwweiboid Figure 2 79 Programming Screen layout 110017276EN Rev B 2 76 Operator s Manual 3 Customizing Your System E Cus
61. techniques by touching them Select a technique a second time to deselect it Figure 3 11 Create New Settings File Screen Once all the desired techniques are highlighted select Confirm and a keyboard will appear through which you can enter the name for the new surgeon file then select Enter The name of the new file will appear on the left side of the screen and a new set of tabs Profile Technique Foot Control and Fluidics will appear across the top of the screen These can be used to further customize the preference file see page 3 6 3 14 Operator s Manual 110017276EN Rev B 3 Customizing Your System ne SSeS Backup a Settings File To backup an existing surgeon preference file to a USB memory device select the Backup Tab from the Manage Settings Screen insert the device into one of the two USB ports behind the round sliding door on the back of the display panel Select the file or files to be backed up the location to which they should be backed up and select Confirm You must select the screen first then insert device The system will only recognize USB device after this screen is selected e Note Memory devices complying with either USB 1 1 or USB 2 0 standards are supported by the Stellaris PC Vision Enhancement System Operations with other USB devices are NOT supported Figure 3 12 Backup Settings File Screen 110017276EN Rev B Operator s Manual 3 15 3 Customizing Your System
62. the status of the Prime and Tune cycle If the system does not pass the Prime and Tune test suggestions for corrective action will be displayed 110017276EN Rev B Operator s Manual 1 21 1 Getting Started x FIAX IV Pole u en TIL as RR gt u OA og E lium Cassette m fe Old eee A 1 CP Figure 1 12 Prime and Tune Screen This is an example of a posterior domain screen 5 Advance to Surgery Phase A WARNING Inadvertent activation of functions that are intended for priming or tuning handpieces while the handpiece is in the eye can create a hazardous situation that could result in patient injury Once the system has been successfully primed and tuned it will automatically move to the main surgical screen Manually selecting Advance to Surgery produces the same result e Note If the system is not primed and tuned the aspiration vitrectomy and ultrasound functions will be unavailable 1 22 Operator s Manual 110017276EN Rev B 1 Getting Started 1 6 Using Your System in Surgery Default parameters and settings are saved in the surgeon preference file but can be modified during a procedure using the on screen controls and surgical settings pop up screens see page 2 7 Your system will display the appropriate surgical screen for the current surgical mode The interface is visibly different depending on the current operational mode See Figure 1 13 for an example of a Posterior Surgi
63. the Foot Control can be stored on the back of the Stellaris PC Vision Enhancement System In some operating configurations the surgeon can change surgical phases using the Foot Control Figure 1 27 Back of Foot Control 110017276EN Rev B Operator s Manual 1 43 1 Getting Started Figure 1 28 Top of Foot Control 1 Right Toe Button 2 Footpedal 3 Right Heel Button 4 Indicator Lights 5 Right LED Wireless 6 Left LED Battery 7 Left Heel Button 8 Left Toe Button Figure 1 29 Bottom of Foot Control 1 Pedal Offset Switch 2 Battery Compartment Door 3 Pedal Pitch Tension Adjustment Knob 1 44 Operator s Manual 110017276EN Rev B 1 Getting Started See Figure 1 30 Pedal Offset Switch Indicator 4 and Pedal Offset Positions 5 6 and 7 4 Pedal Offset Switch Indicator 5 Left Offset for system setup of left foot operation 6 Center Position for system setup for left or right foot 7 Right Offset for system setup for right foot operation Note The pedal offset switch indicator must align with either left right or center pedal offset position Failure to align the indicator appropriately will cause the Foot Control to become inoperable Left or right offset position selections strictly follow system software programming for Left or Right foot operations For example if the system is programmed to right foot operation the indicator 4 can only be set to Center 6 or Right Offset
64. the cassette Scrub Nurse j Connect the air tubing filter to the system second connector down on the right side of the machine Ensure the air pump is on Scrub Nurse or Circulating Nurse k Connect the vitrectomy actuation line blue stripe to the system Scrub Nurse or Circulating Nurse 110017276EN Rev B Operator s Manual 4 51 4 Detailed Reference Note 10 11 4 52 L Insert the fluidics cassette all the way in and hold until it is automatically captured by the system The cassette housing backlight will stop blinking and remain on when the system captures the cassette Scrub Nurse or Circulating Nurse m Pass the bottle spike and irrigation tubing to Circulating Nurse Scrub Nurse n Spike and hang the BSS bottle on the automated I V pole or the Zero Level hanger if using AFI Squeeze and release the drip chamber until it is half filled with solution For AFI setup use the spiking tool provided to puncture the rubber stopper on the bottle before inserting the metal cannula into the bottle Circulating Nurse See Figure 4 5 o Remove the tape on the priming cup Scrub Nurse p Place the priming cup flat on the tray as in the figure below Scrub Nurse Figure 4 32 Priming cup with infusion cannula left aspiration and vitrectomy cutter attached Select the first button from the Easy Prime selection menu to initiate the auto priming and vitrectomy cutter test sequence Scrub Nurse or Cir
65. the cassette or try a different cassette SG04 Call your product service representative if this problem persists VFM19 Warning A Vacuum Fault has occurred licen dd produet rn representative if this problem persists 6 14 Operator s Manual 110017276EN Rev B Foot Control Module Message 6 Troubleshooting iD Type _ Text message suggested action s The Foot Control battery has exceeded 300 charge cycles The Foot Control Info battery may not provide power for the entire day The Foot Control does not have valid WFCO2 Warning factory calibration data Surgical mode is not available The Foot Control is programmed for WFCO3 Info right footed operation but is set up for left footed operation The Foot Control is programmed for left WFCO4 Info footed operation but is set up for right footed operation The Foot Control center pedal or switch WFCOS Warning sensors have failed or the Foot Control has been activated continuously since being powered on WFCOS System not detecting the Foot Control 110017276EN Rev B SG32 If the battery does not provide power for the full day replace the battery SG33 Use the wired cable connection to the system SG34 Replace the Foot Control with another Foot Control using the wired cable connection to the system SG34 Replace the Foot Control with another Foot Control using the wired cable connection to the system SG35 Call your product service repre
66. the effect of the handpiece in the eye for the currently selected phase If the system has the optional MMC the TruLink Customer Support Network can be activated by connecting the Ethernet port on the MMC to a designated Internet enabled network connection and enabling the TruLink amp Customer Support Network data download upon shutdown or Remote Access function if available in your area on the Stellaris PC Vision Enhancement System Kei Note An off the shelf Ethernet cable may be used with the Stellaris PC Vision Enhancement System to establish or restore connections Note The MMC is not intended for diagnostic purposes Before installing the Multimedia Center please take note of the following Multimedia Center must be installed outside of the sterile field Do not place BSS bottles or other containers of fluid on top of the Multimedia Center The AC power source for the Multimedia Center must have a Ground Fault Interrupt 1 12 Foot Control The Foot Control is the main interface between the surgeon and the Stellaris PC Vision Enhancement System The surgeon can control most of the available functions from the Foot Control The Foot Control can be connected through a physical cable or through a wireless Bluetooth connection When the Foot Control cable is not in use make sure to install the attached protective caps into the cable ports This device complies with Part 15 of the FCC U S Federal Communication Comm
67. the patient s eye level Infusion Similar to irrigation particularly referring to fluid use for posterior segment surgery In addition to fluid atmospheric air infusion can also be used in posterior surgery Irrigation Refers to flow of fluid use in the surgery Irrigation flows out of surgical handpieces into the eye through tubing to maintain intraocular pressure MMC Multi Media Center MMC provides two video display functions The first is video overlay where real time system settings are displayed simultaneously on the surgical screen and or projected on external monitors or video recording devices The second function of the MMC is to provide streaming video from the microscope camera to the system display screen Mode Phase It is a subset of the Technique level setting It describes the surgical phase that provides a specific function Example 1 Vitrectomy mode provides vitreous removal functions derived from vitreous cutting and aspiration Example 2 Phaco mode provides lens removal functions derived from lens emulsification and aspiration Stellaris PC allows up to 12 different modes to be programmed in each Technique setting Modulation Ultrasound settings with a unique characteristic such as pulsed burst or waveform More Settings Screens Secondary menu driven graphical user interface screens that allow the user to adjust surgical settings The More Settings Screens are hidden during normal operation and can
68. to 250 PPS by 10 PPS Subject to minimum on time of 2 ms and a minimum off time of 2 ms 5 to 95 by 5 Subject to minimum on time of 2 ms and a minimum off time of 2 ms 2 ms to 20 ms by 2 ms 20 ms to 80 ms by 5 ms 80 ms to 600 ms by 20 ms Linear Front Loaded Back Loaded Reverse Linear Reverse Front Loaded Reverse Back Loaded Phase Case Phase Case Phase Case Phase Case Phase Case Phase Case Phase Case 110017276EN Rev B 3 Customizing Your System E Vitrectomy Options Ranges Step Sizes E Fixed cut rate or linear cut Pneumatic 30 cpm to 5000 cpm Phase Case rate maximum rate 30 cpm to 100 cpm by 10 cpm 100 cpm to 1000 cpm by 50 cpm 1000 cpm to 5000 cpm in steps of 100 cpm Linear cut rate minimum rate Pneumatic 30 cpm to 5000 cpm Phase Case 30 cpm to 100 cpm by 10 cpm 100 cpm to 1000 cpm by 50 cpm 1000 cpm to 5000 cpm in steps of 100 cpm Foot control mapping Linear Front Loaded Back Loaded Reverse Linear Phase Case Reverse Front Loaded Reverse Back Loaded Coagulation Options Ranges Step Sizes BEEN Coag Power level 096 to 1096 by 196 maximum level 1096 to 3096 by 296 30 to 100 by 5 Power level minimum level 0 to 10 by 1 10 to 30 by 2 30 to 100 by 5 Foot control mapping Linear Front Loaded Back Loaded 110017276EN Rev B Operator s Manual 3 35 3 36 Operator s Manual 110017276EN Rev B 4 Detailed Reference Detailed Reference This chapter provi
69. to charge the battery 1 52 Operator s Manual 110017276EN Rev B 1 Getting Started Wireless communication is disabled when the backup cable is in place The Stellaris PC Vision Enhancement System will provide a warning message when the battery is nearing the end of its life Call your customer service representative for a replacement battery See Chapter 7 for a list of local Bausch Lomb offices Foot Control Operation The Foot Control has four buttons and a center footpedal which has two axes of movement to control two linear functions simultaneously The footpedal operates with both the pitch up and down and yaw side to side travel The yaw movement simulates the side switches used on some systems and can be set and programmed for left foot or right foot users Reflux if selected is always activated by inward yaw displacement The center footpedal may be programmed to operate two linear functions simultaneously Dual Linear control The control of linear functions is proportional to the amount of footpedal travel See page 1 57 for description of linear control In single linear mode pitch controls the linear functions selected and yaw movement provides on off control in both directions In Dual Linear mode one linear function is controlled by pitch travel and the other linear function is controlled by yaw travel The table on page 1 59 shows the possible combinations of linear control Figure 1 35 Foot Control labele
70. to minimize such interference a chance interaction cannot be ruled out Patients should be questioned to determine if they have such an implant and if so the manufacturer should be consulted to determine the proper course of action The second port on the left side of the system is for ultrasound handpieces These support phacoemulsification and fragmentation procedures in continuous pulsed and burst modes 110017276EN Rev B Operator s Manual 1 35 1 Getting Started Coagulation The third port on the left side of the system is for a coagulation handpiece which provides coagulation power in either Fixed or Linear modes See page 4 46 for details of use and page 8 13 for technical specifications The front of the system contains a total of ten ports for connecting system accessories Only some ports are active the remainder are reserved for future use Foot Control The Foot Control contains the Footpedal and four programmable buttons and provides the main interface between the user and the vision enhancement system for controlling most functions The Foot Control can be used in a wired or wireless mode See page 1 40 for detailed instructions for its use and page 8 10 for technical specifications Fluidics Function This function uses a vacuum based pump to control the output vacuum range from 0 to 600 mmHg and uses a rigid 300 ml collection cassette with attached irrigation and aspiration tubing Pneumatic vitrectomy supports
71. will automatically turn ON the irrigation valve to provide continuous irrigation System and MMC need to be restarted to resume operation To restart system perform the following A Power down system by pressing and holding the standby power switch in front of the system B Wait until the system powers down completely C Power down MMC by pressing and holding the power switch until the light turns brighter if not already powered down D Restart MMC by pressing the power switch E Restart system by pressing the standby power switch once F Repeat system set up sequence Prime and Tune system to resume operation GUI hung up and system ceased operation 6 5 System Configurations Modules Accessories and Packs Use of non approved accessories packs or parts may affect system performance The unauthorized modification or alteration of the equipment or the use of non approved accessories packs or parts with the equipment shall relieve Bausch Lomb from any warranty service obligation or other liability for damages to or failure of the equipment caused by such unauthorized acts For additional information please contact a Bausch Lomb sales representative or your local sales office The system configurations modules accessories and packs provided on the following pages are to be used with the Stellaris PC Vision Enhancement System Although not provided in the list the ultrasound needles I A handpiece I A tips
72. 1 Warning in the system Surgical mode is not available The compressor module software version SG02 Call your product service CPX02 Warning is not compatible with this software representative A compatible software version Surgical mode is not available version must be downloaded The compressor module has failed to i respond to a settings command The SG04 Call your product service MEL module settings have been re sent to the representative if this problem persists module SGO1 Call your product service representative The compressor module has reset The SG04 Call your product service CPX04 Warning module settings have been re sent to the AUAM i module representative if this problem persists SG44 Check that the air line tubing is connected tightly to the system SG45 Check that there are no leaks in d The air pressure output is lower than the air line and that the air line tubing Send Wants commanded is connected tightly to the other pack components SG04 Call your product service representative if this problem persists 6 4 Operator s Manual 110017276EN Rev B B u v ui R SG90 Increase input pressure to 72 5 to E 100 psi 5 0 bar 6 9 bar o 110017276EN Rev B The air pressure output is higher than commanded The internal air pressure system cannot reach the full pressure expected The internal vitrectomy air pressure is low Viscous fluid injection pressure is
73. 110017276EN Rev B 7 Service and Warranty e to Bausch Lomb in writing within the twelve 12 month warranty period This Warranty does not apply to normal wear and tear or disposable components used in connection with the Stellaris PC Vision Enhancement System BAUSCH LOMB EXCLUDES AND DISCLAIMS ALL OTHER WARRANTIES OR REPRESENTATIONS RELATING TO THE Stellaris PC Vision Enhancement System WHETHER EXPRESS IMPLIED OR ARISING BY OPERATION OF LAW INCLUDING BUT NOT LIMITED TO ANY WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE IN NO EVENT SHALL BAUSCH LOMB BE LIABLE FOR AND IT SPECIFICALLY DISCLAIMS RESPONSIBILITY FOR ANY INCIDENTAL CONSEQUENTIAL SPECIAL OR EXEMPLARY DAMAGES OR EXPENSES ARISING OUT OF THE PURCHASE OR USE OF THE Stellaris PC Vision Enhancement System OR THIS WARRANTY EVEN IF BAUSCH LOMB HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH LOSS DAMAGE OR EXPENSE THE LIABILITY OF BAUSCH LOMB TO THE PURCHASER OR ANY USER FOR ANY CLAIM RELATED TO THE Stellaris PC Vision Enhancement System OR THIS WARRANTY WHETHER IN CONTRACT TORT STRICT LIABILITY OR OTHERWISE SHALL NOT EXCEED THE PURCHASE PRICE OF THE Stellaris PC Vision Enhancement System PAID TO BAUSCH LOMB Handpiece Warranty Bausch Lomb warrants ultrasonic handpieces against defects in materials and workmanship under normal use for the for the minimum period of 6 six months from the date of delivery unless otherwise specified on your s
74. 17276EN Rev B 3 Customizing Your System GE ne SSeS Customize Video Overlay To set the parameters for the MMC Video Overlay functions select the Video Overlay Tab on the Surgeon Level Programming Screen Through this tab you can set whether or not the system will combine Video Overlay Format information U S Averages settings and case information By default the U S data is shown as three separate lines on the video overlay If the U S combine option is set to Yes the display will appear on one line which will step through the three values Similarly settings are normally displayed on four lines and case information on two lines but if the combine option is set to Yes each will appear on one line that will step through the values You can select the language to be used on the Video Overlay You can set the Video Overlay overscan rate from 0 to 5 j mmtm nn Vases Genren Language en D veto Ovurtey Format Dr Jones f Figure 3 10 Customize Video Overlay Screen 110017276EN Rev B Operator s Manual 3 13 3 Customizing Your System 3 3 Manage Surgeon Files Create a New Settings File To create a new surgeon preference file select the Create Tab from the Manage Settings Screen then select the existing surgeon file which has settings most similar to the file you are going to create Once you have highlighted a file the techniques in that file will be listed on the right side of the screen Select one or more
75. 18 Combined End of Case Screen Remove the fluidics cassette immediately Remove all disposables from the system Select Show Me Steps Remove Disposables to see a list of which disposables need to be removed and animations of how to remove each of them Select Next Patient to return to the Setup Screen and prepare the machine for the next procedure or select Shut Down System to power down the system 1 28 Operator s Manual 110017276EN Rev B 1 Getting Started 1 8 Shutting Down the System A CAUTION Never turn the power switch off or disconnect the power without proper system shutdown Equipment damage can occur From the System End Screen select Shut Down System Select Yes to confirm shut down or No to go back to the End Screen The system may take a few minutes to shut down The front panel light will glow brighter when shut down is complete If you have the TruLink Customer Support Network option enabled the system will ask if you want to upload system data to the Enterprise Server Ensure the Ethernet cable is connected from the port at the bottom of the Stellaris PC Vision Enhancement System to the hospital network port before attempting to upload data The system will send diagnostic data no patient data is transferred then shut down when finished When shutting down the system make sure to recharge the Foot Control as described on page 1 51 1 9 Power Interruptions If the Stellaris PC Vision Enhancemen
76. 2 110017276EN Rev B Index Operator s Manual Index EN Coagulation More 2 22 2 58 Computer Unit Specifications 8 8 Connections Electrical 1 2 CPM cuts per minute 2 59 Customize Exception 3 6 D Date Format 3 18 Date Setting 3 18 DC Duty Cycle 2 20 2 39 2 56 2 73 4 33 Delete Settings File 3 17 Description IV Pole 1 34 System 1 5 Display Level 1 2 67 Display Level 2 2 74 Disposables Setup and Use Coagulation Fixed 4 47 Linear 4 48 Phacoemulsification 4 37 Dual Linear Control 1 51 Duty Cycle 2 20 2 39 2 56 2 73 4 33 E Effective Phaco Time EPT 4 33 Enterprise Server 1 27 Equipment Classifications 8 2 Error Messages 6 3 Ethernet Cable 1 7 Exceptions 2 34 2 68 F Fluidics Vacuum 4 1 Foot Control 1 3 Description 1 34 1 38 Functions 1 51 Linear Control 1 56 Operation Aspiration 4 31 Irrigation 4 31 Vitrectomy 4 42 Specifications 8 9 Footpedal 1 52 Operator s Manual 110017276EN Rev B Footpedal More 2 24 Footpedal Status 2 40 2 73 Fuse Replacement 6 2 H Handpiece Cleaning Bipolar Accessories 5 2 For U K 5 11 Irrigation Aspiration 5 3 Sterilization Bipolar Accessories 5 2 For U K 5 11 Height IV Pole 2 55 I VA Handpiece Cleaning 5 4 Sterilization 5 5 Irrigation Handpiece Cleaning 5 4 Sterilization 5 5 Operation 4 30 IV Pole 2 39 2 71 Description 1 34 Specifications 8 11 IV Pole Height 2 39 2 71 3 32 K Keyboard 2 4 L Language 2 30 2 65
77. 2 2776 0408 Fax 88 62 2776 6849 Thailand Bausch amp Lomb Thailand Limited 54 B B Building 15th Floor Room 1501 Sukhumvit 21 Asoke Road Kwaeng Klong Toey Nua Khet Wattana Bangkok 10110 Thailand Tel 66 2 259 65 10 Fax 66 2 259 6511 Turkey Bausch amp Lomb Saglik ve Optik Urunleritic A S Degirmen Yolu sok Sasmaz Plaza No 4 Kat 12 Daire 24 Kozyatagi Istanbul Turkey Tel 90 216 373 3131 switchboard Fax 90 216 384 9489 Tel 33 4 37 488383 Fax 33 4 37 488384 United Kingdom Bausch amp Lomb U K Ltd 106 114 London Road Kingston upon Thames Surrey KT2 6TN England Tel 44 20 878 1 2900 Fax 44 20 8781 2901 Tel 44 208 78 1 0000 Fax 44 208 781 0001 Europe Middle East amp African Division European Headquarters Vietnam c o address is Singapore see Singapore 110017276EN Rev B Operator s Manual 7 9 7 Service and Warranty 7 2 Environmental Protection Accessories such as disposable packs handpieces and tubing will be contaminated with human tissue fragments and bodily fluids during the surgical process These should be handled and disposed of in accordance with current biomedical procedures The system and accessories and Foot Control may in use become contaminated with fluids from the operating field and should be treated as biohazards and therefore need to be decontaminated When discarding any major component of the system use local market techniques for disp
78. 3 27 for details on which options can be customized at which level Customize Profile To change the surgeon s name associated with a settings file or change the default language select the Profile Tab on the Surgeon Level Programming Screen Select the surgeon s name and use the keyboard interface that appears to modify the name of that file Select Screen Voice Confirmation drop down menu and a list of all available languages will appear and you can select the one you prefer You can also enable or disable use of the remote control Figure 3 3 Profile Tab on Surgeon Programming Screen 3 4 Operator s Manual 110017276EN Rev B 3 Customizing Your System E Customize Technique To change the techniques available for a particular surgeon or modify their settings select the Technique Tab on the Surgeon Level Programming Screen and a list of currently defined techniques will appear You can select any technique from the current list and use the Move Up and Move Down buttons to rearrange the order in which they appear Select Add to add a new technique to the surgeon s list Select a technique then select Delete to remove it or select Customize to continue programming that technique Figure 3 4 Techniques Tab on Surgeon Level Programming Screen Surgeon Level Foot Control Fluidic A V and Video Overlay settings can also be controlled from the corresponding tab Select the right pointing arrow to show the Video
79. 4 F 30 0 psi Refer to your institution s policies regarding restrictions on the use of sterilization Operator s Manual 110017276EN Rev B 5 Cleaning and Sterilization Requirements een Automated Cleaning 1 Inspect the Stellaris PC Vision Enhancement System s Ultrasound handpiece to ensure that it is free of any gross soiling or debris If gross soiling or debris is evident manual pre cleaning with a neutral pH detergent with a disposable cloth or paper wipe while wearing appropriate personal protective equipment may be necessary It is recommended that the Stellaris PC Vision Enhancement System s Ultrasound handpiece be reprocessed as soon as is reasonably practical following use 2 Connect the lumens of the Stellaris PC Vision Enhancement System s Ultrasound handpiece to the lumen connectors or adaptors of the washer to allow detergent and rinse water to circulate freely through the lumens of the handpiece 3 Ensure that the Stellaris PC Vision Enhancement System s Ultrasound handpiece is placed within the washer such that all surfaces of the Stellaris PC Vision Enhancement System s Ultrasound handpiece components are accessible to the detergent and rinse water during cleaning and the Stellaris PC Vision Enhancement System s Ultrasound handpiece does not move about excessively during cleaning 4 Process the Stellaris PC Vision Enhancement System s Ultrasound handpiece according to the conditions listed
80. 5 5 Cleaning and Sterilization Requirements 5 4 Ultrasound Handpiece and Accessories The ultrasound handpiece reusable accessories and cord should be inspected before each use for signs of contamination or other damage If the handpiece its cord or any reusable accessory show signs of damage or cracked insulation it should not be used The handpiece must be flushed clean and autoclaved before being placed into service the first time before initial use each day and after each use in accordance with the following instructions ea Note Use compressed filtered medical grade air medical grade nitrogen to blow out the handpiece lumens The pressure should not exceed 29 psi 200 kPa 2 bar Note Remove the rubber plugs from the tip of the handpiece and lumen port s at the end of the handpiece before autoclaving and placing into service for the first time Note To maintain flexibility and prevent cable damage wind the cord only loosely if needed and do not store it coiled with a less than 6 diameter Handpiece Cleaning Instructions Bausch Lomb recommends the use of the Universal Maintenance Kit CX7120 in the following instructions The irrigation sleeve needle and tubing must be removed from the handpiece before beginning A Remove the silicone irrigation sleeve and the needle Remove any tubing from the rear of the handpiece See Figure 5 3 and Figure 5 4 Rinse the exterior of the handpiece by holding it under cold
81. 800 567 2696 Fax 905 578 0103 Customer service 1 800 387 3284 China Bausch amp Lomb Surgical Room 906 909 Tower 1 No 218 Tianmu Road W Shanghai 200070 P R China Tel 86 21 6317 7143 Fax 86 21 6354 7780 France Bausch amp Lomb France SAS 416 rue Samuel Morse Le Millenaire CS79005 34967 Montpellier Cedex 2 France Tel 33 4 67 12 30 30 Fax 33 4 67 12 30 31 General Tel 33 4 67 12 30 68 Fax 33 4 67 12 30 66 Bausch amp Lomb France SAS DistOps Office Tel 33 4 37 48 83 83 Reception Fax 33 4 37 48 83 84 Reception Germany Bausch amp Lomb GmbH Im Schumachergewann 4 69123 Heidelberg Germany Tel 49 6221 823184 Fax 49 6221 823149 Hotline within Germany 0800 2233331 7 4 Operator s Manual 110017276EN Rev B Greece Bausch amp Lomb Greece 73 Apostolopou Street Chalandri 15231 Athens Greece Tel 30 210 674 8170 Fax 30 210 674 8234 Tel 33 4 37 48 83 83 Fax 33 4 37 48 83 84 Hong Kong Bausch amp Lomb Asia 15 F One Kowloon Wang Yuen Street Kowloon Bay Kowloon Hong Kong Tel 85 2 2 213 3333 Fax 85 2 2567 8170 India Bausch amp Lomb Eyecare India Private Ltd 2nd Floor Tower A Building no 8 DLF Phase II DLF Cyber City Gurgaon 122002 Haryana India Tel 91 124 4152 100 Fax 91 124 4152 236 Indonesia Bausch amp Lomb Indonesia c o address in Singapore see Singapore Italy Bausch amp Lomb IOM S p a Via Pa
82. ARNING For optimum aspiration and reflux performance the patient s eye level must be at the same level as no more than 7 cm 3 in from the Stellaris PC Vision Enhancement System aspiration port Failure to follow this procedure may result in serious and permanent patient injury A Note Specific instructions for cleaning and sterilization included with the handpiece or accessory take precedence over these instructions 1 Turn Power on 2 Press any button on the Foot Control and wait until the ready light turns solid green indicating wireless communication has been established 3 Select Surgeon s Name and select Confirm 4 40 Operator s Manual 110017276EN Rev B 10 4 Detailed Reference Open the disposable phaco package and insert the fluidics cassette all the way in and hold until it is automatically captured by the system The cassette housing backlight will stop blinking and remain on when the system captures the cassette Spike the BSS bottle and hang it at the desired bottle height If pressurized infusion is used Connect the Air Tubing Line to the vent port at the bottle spike and the other end with air filter to the Stellaris PC Vision Enhancement System air output connector Switch on the air pump from the system setup screen the control is at the upper right hand of the screen The output connector will remain lit when it is at commanded pressure and blink on and off when it is not at the commanded p
83. ASP Air consumption Increase Decrease Up Phase i Ultrasound Power Increment U S Vitrectomy Decrement Coagulation shared button Parameter increment Future Use decrement 110017276EN Rev B Operator s Manual 8 11 8 Specifications IV Pole Specification Provides two 2 bottle hooks Capable of lifting two 500 ml glass bottles of balanced salt solution Range of 110 cm 43 3 in Travel 30 cm to 140 cm 13 8 in to 55 in from aspiration port an 10 6 cm sec 4 in sec Controlled via touch screen entry remote Control control Foot Control or directly via buttons on the back of the system Relative from home sensed position 8 12 Operator s Manual 110017276EN Rev B 8 Specifications eee Coagulation Function Specifications Specification Single Floating BF Connection Connector Coaxial connector Coagulation Connections United States Banana Jack Cord Banana Jack to Coaxial adapter International Reusable Coaxial Cord Modes of Operation Linear Mode Fixed Mode Linear Mode Operating Parameters Fixed Control 110017276EN Rev B Output Range 7 5 Watts Nominal 100 ohms Frequency 1 MHz nominal Maximum Peak Open Circuit Voltage 120V Range Programmable from 0 to 100 in 1 increments Control Linear control of coagulation power via the footpedal Output Range 7 5 Watts Nominal 100 ohms Frequency 1 MHz nominal Maximum Peak Open Circuit Vol
84. D o gt o gt 120 gt 120 SEAR EE e m m sw z uo s EE gt 10 60 gt 12 60 200 2120 Note The exposure from all light sources is cumulative and additive Note If the intensity of any of the light sources is reduced to 5096 of the maximum intensity the exposure time for that light source to reach the exposure guideline is doubled This linear relationship can be used to determine the time to reach the exposure guideline for the combination of light sources at various intensity settings Note The ISO 15004 2 2007 weighted radiant exposure guideline is 10 J cm2 Note When using two lamps simultaneously at arbitrary settings the formula for calculating the time to reach the exposure threshold with both lamps running is tc 1 s1 t1 100 s2 t2 100 where tc time to reach the threshold for the combination of the two lamps 110017276EN Rev B Operator s Manual 1 63 1 Getting Started s1 setting of lamp 1 in 100 s2 setting of lamp 2 in 100 11 100 time to reach the threshold with lamp 1 at 100 12 100 time to reach the threshold with lamp 2 at 100 e Note The use of fibers with wider fields of illumination than focal probes at the same setting and working distance will increase the time before the guidance threshold is exceeded Thermal High intensity visible and infrared light is absorbed as heat in the retina The Stellaris PC Vision Enhanc
85. EIVO4 Warning module settings have been re sent to the module EIVOS Warning The IV pole position cannot be determined The IV pole is not detecting the home EIVO7 Warning position switch or the IV pole motor may have failed The IV pole panel button sensors have EIVOS8 Warning failed or the buttons have been activated continuously since being powered on 6 6 Operator s Manual SOU Call your product service representative SG02 Call your product service representative A compatible software version must be downloaded SG04 Call your product service representative if this problem persists SG04 Call your product service representative if this problem persists SG62 Please command the IV pole to the minimum bottle height position SG04 Call your product service representative if this problem persists SG62 Please command the IV pole to the minimum bottle height position SG04 Call your product service representative if this problem persists SG64 Ensure that the IV pole back panel buttons are not activated SG65 Confirm proper operation of the IV pole back panel buttons SG04 Call your product service representative if this problem persists 110017276EN Rev B Light Module Messages The light module was not detected in the Warning system Illumination and viscous fluid control are not available The light module software version is not compatible with this software version Warning WER
86. Figure 2 17 Viscous Fluid Control Visc Infusion Illuminators Foot Control A V Messages Figure 2 18 When the Dual Yaw Vac submode is selected on the popup the Vacuum tab is also displayed Each More Settings Screen has a dropdown submode selection window x as well as Save Save As and Cancel amp buttons Selecting Save As allows you to save the new parameters to a particular surgeon technique and gauge file 110017276EN Rev B Operator s Manual 2 7 2 User Interface Figure 2 12 Setup Screen with Linear Coagulation function active 2 8 Operator s Manual 110017276EN Rev B 2 User Interface Figure 2 13 Setup Screen without Linear Coagulation function active 110017276EN Rev B Operator s Manual 2 9 2 User Interface Figure 2 14 Vitrectomy Cut More Settings Screen tab 2 10 Operator s Manual 110017276EN Rev B 2 User Interface Figure 2 15 Anterior Vitrectomy More Settings Screen tab 110017276EN Rev B Operator s Manual 2 11 2 User Interface Figure 2 16 Phaco More Settings Screen tab 2 12 Operator s Manual 110017276EN Rev B 2 User Interface Frag Figure 2 17 Ultrasound More Settings Screen tab for Fragmentation 110017276EN Rev B Operator s Manual 2 13 2 User Interface Figure 2 18 Viscous Fluid Control More Settings Screen tab 2 14 Operator s Manual 110017276EN Rev B 2 User Interface Extrude
87. Fluid Air Exchange function status and pressure will return to the value it had prior to turning Elev Inf on and the timer will be cleared from the screen S F AX IV Pole le cmr oO Bu ee EH e 00 01 07 e Figure 4 15 Surgical screen displays Elevated Infusion control status ON and timer 110017276EN Rev B Operator s Manual 4 21 4 Detailed Reference Fluid Tamponade Similar to the Air tamponade Fluid tamponade is a function where the fluid infusion pressure is temporarily elevated to a pre programmed level The Fluid Tamponade can be driven by pressurized air or gravity infusion The Fluid Tamponade function is enabled by the Elev Inf On Off button on the display or the foot control switch if it is programmed to control the Elevated Infusion Adjusting IV Pole above 81 cm will also enable elevated infusion The tamponade pressure is displayed in the surgical screen and may be adjusted by selecting the numeric pressure display or using the touchscreen Up Down arrows Fluid Tamponade would also be enabled whenever the Fluid Air Exchange pressure level is raised or the I V pole is adjusted above the programmed tamponade level When the function is enabled a voice confirmation will sound and an elapsed time counter will be displayed in the surgical screen A voice confirmation for tamponade duration will be provided at one minute intervals A bell will be sounded at 30 second intervals When Elev Inf is
88. G55 Confirm proper operation of the coagulation handpiece in a beaker of BSS activate the function and ensure the error message does appear again If similar message appears stop using the function and call B amp L service support SG56 Unplug the handpiece and try another bipolar coagulation cord SG04 Call your product service representative if this problem persists SG53 Unplug the handpiece and try another ultrasound handpiece SG04 Call your product service representative if this problem persists 110017276EN Rev B 6 Troubleshooting Vacuum Fluidics Module Messages Suggested Action s The vacuum fluidics module was not VEMO1 Warning detected in the system Surgical mode SGO1 Call your product service with the vacuum fluidics module is not representative available bo orn HUS E SE SG02 Call your product service version is not compatible with this VFMO2 Warning representative A compatible software software version Surgical mode is not available version must be downloaded The vacuum fluidics module has failed SG03 Confirm correct infusion aspiration gt respond to a settings command The and vitrectomy function MEMOS Worning module settings have been re sent to the SG04 Call your product service module representative if this problem persists T SG03 Confirm correct infusion aspiration The vacuum fluidics module has reset and vitrectomy function VFMO4 Warning The module settings h
89. I AAMI ST79 2006 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities and or your institution s policies regarding restrictions on the use of flash sterilization 5 5 Special Instructions for United Kingdom Users Flush aspiration lumen phaco as follows A B SD m go Place the end of the syringe into a beaker of warm 30 C to 40 C distilled or deionized water and fill the syringe to the 50 cc ml mark Connect the syringe to the center stopcock fitting Rotate the stopcock lever to allow flow to the female luer fitting Connect the stopcock female luer fitting to the handpiece aspiration fitting Push on the syringe plunger to force fluid through the handpiece into another beaker for proper disposal Do not draw flushing fluid back through the handpiece Disconnect the syringe Repeat Steps A through E at least three times Prepare a neutral pH detergent solution using warm distilled or deionized water per the detergent manufacturer s labeling instructions Immerse aspiration brush part of CX7120 Universal Maintenance Kit into the detergent solution sufficiently to cover all of the brush bristles From the rear of the handpiece insert the aspiration brush into the aspiration fitting Push the brush bristles through the handpiece aspiration lumen several times Care must be taken not to create an aerosol effect by pushing the bristles past the end of the handpiece Then pul
90. Korean Russian Video overlay display format Combine U S Averages Display Combined Display Surgeon No Display Combine settings lines No Yes Video overlay overscan 096 to 596 by 196 Surgeon allowance Technique Name Typewriter Data Entry 20 characters max Surgical Mode Display Format 1 Format 2 Anterior Domain Only Format Status Bar Display Format Anterior Formats 1 2 and 3 Technique Combined Formats 1 and 2 only Posterior Format 1 only not user programmable when available 110017276EN Rev B Operator s Manual 3 27 3 Customizing Your System 5 Case Customization Levels Options Ranges Step Sizes p Customize Settings by Case Disabled Enabled by Needle Tip by Cataract Grade by Pathology Settings by Needle Tip Settings by Cataract Grade Settings by Pathology Mode Type Ultrasound Irrigation Aspiration Irrigation Coagulation Phase Vitrectomy Ultrasound Submode Name Typewriter data entry 20 characters max 3 28 Operator s Manual 110017276EN Rev B 3 Customizing Your System E i Foot Control Parameter Options Ranges Sizes E Mode change Not While Active Allow Limit Pedal Allow Remap Pedal and Surgeon control Allow No Limiting Disabled Enabled R1 R2 R3 Enabled R2 R3 Starting position Region 1 2 to 5 lt R2 start by 5 Surgeon Region 2 5 gt R1 start to 5 lt R3 start by 5 Region 3 5962 R2 start to 95 by 5 Group toe heel Le
91. Manual 110017276EN Rev B Preface Table of Contents Getting Started User Interface Customizing Your System Detailed Reference Cleaning and Sterilization Troubleshooting Service and Warranty Specifications Glossary Index 9208 J23Jd Ua U0 JO 2106 payers Duap e2ejlaju Jos wa sAs Jno Bulziwo sn 22U9J9J23 paliejag uonezuuaie pue Duiuea Dunoousaigno1l Ayuessem pue 3911135 suonerijinads Asessoj9 xapuj
92. N Rev B 1 Getting Started System Console mmm Bausch Lomb Stellaris 20 Figure 1 20 Front of Stellaris PC system 1 IV Pole 2 Pneumatic Actuation Port 3 Posterior Handpiece Connectors 4 Drawer 5 One Touch Wheel Locking 6 User Interface screen 7 System Switch On Off 8 Handpiece Connectors 9 Fluidic Module 10 System Tray This is the main unit which contains the connections for all handpieces Mayo tray Ethernet connection and system housing On the rear of the main unit see Figure 1 21 on page 1 34 near the IV Pole are three buttons that move the IV Pole up down or back to the preset height for the current mode of operation The console also contains the power supply 110017276EN Rev B Operator s Manual 1 33 1 Getting Started For systems left idle more than seven days the Foot Control must be charged for six hours before use to ensure proper operation A CAUTION To prevent loss of data save data before the system shuts down Figure 1 21 Stellaris PC System Rear View 1 USB Port Access 2 IV Pole Control Buttons 3 Cord Wrap Hooks 4 Foot Control Hook 5 Air Pressure Output connector The front of the system see Figure 1 22 on page 1 35 contains multiple ports for connecting system accessories There are five ports down the left side of the system of which only the second and third are active The second port is for ultrasound handpieces phacoemulsification and fragme
93. Stellaris PC Vision Enhancement System located on the label on the back panel Date of purchase 110017276EN Rev B Operator s Manual 7 1 7 Service and Warranty Description of problem listing all observable symptoms and characteristics and details of occurrence Was patient involved at time of occurrence Returns To return a Stellaris PC Vision Enhancement System and Jor system assembly or component to Bausch Lomb for service a return authorization number must be obtained from your local Product Support team prior to returning any unit for repair or calibration The following information must accompany all returned units Customer account number Customer name address and telephone number Name of function handpiece etc that needs service e Model number REF and serial number SN of Stellaris PC Vision Enhancement System located on the label on the back panel Date of purchase Description of the problem or service desired List all observable symptoms and characteristics and details of occurrence Was patient involved at time of occurrence Return authorization number assigned by our Global Product Support specialist Contact name and phone number if additional information is required Ship or otherwise return the part transportation and insurance prepaid to your local Bausch Lomb International Facility unless otherwise instructed For accessories and disposable handpieces contact you
94. The cassette has just become nearly full The cassette is full The vitrectomy cutter output pressure is low Vitrectomy cutter may not be cutting Unrecognized cassette SG26 Arrange the soonest convenient time to empty the cassette To empty cassette and reprime 1 Clamp irrigation line 2 Select the Setup icon 3 Eject the cassette 4 Empty the cassette 5 Re insert the cassette 6 Open irrigation clamp 7 Select Prime to prime cassette 8 After priming select Advance to Surgery to resume surgery Refer to operator s manual for detailed instructions to detach tubing manifold from the cassette SG27 Call your product service representative if the cassette is not nearly full and this message persists SG28 Empty the cassette To empty cassette and reprime 1 Clamp infusion line 2 Select the Setup icon 3 Eject the cassette 4 Empty the cassette 5 Re insert the cassette 6 Open irrigation clamp 7 Select Prime to prime cassette 8 After priming select Advance to Surgery to resume surgery Refer to operator s manual for detailed instructions to detach tubing manifold from the cassette SG29 Call your product service representative if the cassette is not full and this problem persists SG30 Check that the vitrectomy cutter tubing is connected tightly to the system SG31 Confirm correct vitrectomy function SG04 Call your product service representative if this problem persists SG83 Please re insert
95. Time Tab the top of the System Setup Screen Select from the option list menus to change the default system language month day year clock format 12 or 24 hour and current time in hours and minutes Once all changes have been made select Confirm at the bottom of the screen to make your changes effective immediately System Sctup SS x u En ER 2 eran PM Get e nr Year Qa M A Format cm TEX J Hours summ Figure 3 15 Set System Date Time Screen 3 18 Operator s Manual 110017276EN Rev B 3 Customizing Your System LSS SSS System ID To monitor or change the identifying names of your Stellaris PC Vision Enhancement System select the System ID Tab at the top of the System Setup Screen You can enter or update the account name and system name that have been assigned to your Stellaris PC Vision Enhancement System You can view the system catalog number as well as its installation number but these are not editable Figure 3 16 System ID Screen 110017276EN Rev B Operator s Manual 3 19 3 Customizing Your System Rooms To assign names to the operating rooms in which your Stellaris PC Vision Enhancement System is used select any room button the keyboard will appear and you can enter the name for that room Select Enter and the room name will be saved You can also set the Maximum IV Pole Height in centimeters as measured from the aspiration port in the fluidics syst
96. V Pole mmHg Figure 2 42 IV Pole Control display The upper right corner of the screen displays the current setting for the IV Pole displayed numerically at the top of the test tube You can use the up and down arrows to change the height and the IV Pole will automatically move up and down to match the setting The On Off button controls the continuous irrigation function by opening or closing the irrigation pinch valve in the fluidics system If the irrigation control is turned off in anterior mode the function will still be managed by the Foot Control when the footpedal enters Region 1 irrigation will commence Selecting the fill button opens the pinch valves in the fluidics system for 20 seconds This function is useful for filling surgical beakers without using BSS A green ring around the button shows indicates that the fill system is currently on You can select the fill button to toggle to the off state The automatic Fill function is user programmable with a fill time range from 20s to 120s To program the fill time perform the following steps Select the More Screen Select the Infusion tab e Change the fill time Fill sec to the desired value Select Save to save changes Air Pressure When using Air Forced Infusion the air pump will turn ON after the cassette vacuum check is completed The upper right corner of the screen displays the actual air pressure The actual air pressure may not rea
97. Yaw Fixed Minimum Vacuum in Region 2 Once irrigation has been initiated and the footpedal has been depressed approximately five degrees or as programmed an increase in footpedal resistance will be noted signifying the transition from Region to Region 2 and the start of aspiration The minimum set aspiration will be developed in Region 2 Linear aspiration to the maximum setting will be controlled by outward yaw footpedal travel The screen will display the actual amount of aspiration Ultrasound power is activated in Region 3 of footpedal travel Another momentary increase in footpedal resistance will be noted signifying the transition from one region to the next and the start of ultrasound power Linear ultrasound power will be initiated and controlled as a linear function of footpedal travel in Region 3 see note Dual Linear Ultrasound Mode with Aspiration in Yaw and Linear Aspiration Linear Vacuum in Region 2 Once irrigation has been initiated and the footpedal has been depressed approximately five degrees or as programmed an increase in footpedal resistance will be noted signifying the transition from Region 1 to Region 2 and the start of aspiration Aspiration will increase from zero to the minimum level in proportion to footpedal travel in Region 2 Linear aspiration to the maximum setting will be controlled by outward yaw footpedal travel The screen will display the actual amount of aspiration Ultrasound power is activated i
98. a the Max Vacuum input on the touch screen You can program Region 2 to provide either fixed or linear vacuum control The Actual Vacuum display will indicate the current aspiration level If enabled an audible linear tone will indicate aspiration The pitch of the tone increases with increased aspiration Irrigation Aspiration Setup A WARNING For optimum aspiration and reflux performance the patient s eye level must be at the same level as no more than 7 cm 3 in from the Stellaris PC Vision Enhancement System s aspiration port Failure to follow this procedure may result in serious and permanent patient injury A WARNING Assure the handpiece and accessories are sterilized before use as specified e Note Specific instructions for cleaning and sterilization included with the handpiece or accessory take precedence over these instructions 1 Turn Power on 2 Press any button on the Foot Control and wait until the right light turns solid green indicting wireless communication has been established 110017276EN Rev B Operator s Manual 4 31 4 Detailed Reference 3 Select Surgeon s Name and select Confirm 4 Open the disposable package and insert the fluidics cassette all the way in and hold until it is automatically captured by the system The cassette housing backlight will stop blinking and remain on when the system captures the cassette 5 After the vacuum test completes the Setup Screen will display w
99. al Avenida do Forte N 3 Edificio Suecia IV Piso O Esq 2795 504 Carnaxide Lisbon Portugal Tel 351 214 24 1510 Fax 351 214 24 1519 Singapore Bausch amp Lomb S Pte Ltd Bausch amp Lomb S Pte Ltd 151 Lorong Chuan 04 03A New Tech Park Lobby C Singapore 556741 Tel 65 6834 9112 Fax 65 6286 0448 110017276EN Rev B 7 Service and Warranty EH Operator s Manual 7 7 7 Service and Warranty L_ _E SEES South Africa Bausch amp Lomb South Africa Pty Ltd P O Box 5435 Rivonia 2128 South Africa Street address Bausch amp Lomb House 19 Autumn Street Rivonia Sandton South Africa Tel 27 11 259 2600 Tel 27 82 820 5845 Fax 27 11 259 2650 Spain Bausch amp Lomb S A Avda Valdelaparra 4 28108 Alcobendas Madrid Spain Tel 34 9 1 657 6300 Fax 34 91 661 4266 Tel 34 902 381 010 Fax 34 902 250 310 Sweden Denmark Finland Norway and Sweden Bausch amp Lomb Nordic AB S der Milarstrand 45 P O Box 15070 S 104 65 Stockholm Sweden Tel 46 8 616 9500 Fax 46 8 669 8623 Tel 46 8 616 9585 Fax 46 8 658 2541 Switzerland Bausch amp Lomb Swiss AG Dammstrasse 19 6301 Zug Swiss Tel 0848 228726 7 8 Operator s Manual 110017276EN Rev B 7 Service and Warranty FF gt OUv Gm Taiwan Bausch amp Lomb Taiwan Ltd 11th Floor No 102 Section 4 Civil Boulevard Taipei 10690 Taiwan Republic of China Tel 88 6
100. ales tender or contract If any such defect occurs within the warranty period contact Bausch Lomb to return the handpiece for replacement Bausch Lomb will as its sole obligation under this warranty and at its sole discretion replace the defective handpiece with either a new or repaired refurbished handpiece All replacement handpieces are covered for the balance of the warranty period remaining on the original handpiece Bausch Lomb will arrange for replacement at no charge Loss or damage in return shipment to Bausch Lomb shall be at purchaser s risk The warranty shall not apply to and Bausch Lomb shall not be responsible for any loss arising in connection with the purchase or use of any handpiece which has been repaired or altered in any way so as in Bausch Lomb s judgment to affect its reliability or which has been subject to misuse negligence or accident or which has had the serial or lot number altered defaced or removed or which has been used otherwise then in accordance with the instructions furnished by Bausch Lomb Bausch Lomb neither assumes nor authorizes any representative or other person to assume for it any other liability in connection with the sale of such handpieces BAUSCH LOMB DISCLAIMS ALL OTHER WARRANTIES EXPRESS OR IMPLIED INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR APPLICATION OTHER THAN THOSE EXPRESSLY SET FORTH IN THE APPROPRIATE PRODUCT LABELING OR
101. allow the flow to fill the irrigation tubing up to the handpieces See page 2 39 for details on the irrigation flow button activate the Fill button with turn flow on for 20 seconds Fill the test chamber with irrigating solution then slide over the tip of the handpiece Select Prime and Tune A vacuum test is part of the priming cycle After successful priming and tuning the Main Surgical Screen will appear 110017276EN Rev B Operator s Manual 4 53 4 54 Operator s Manual 110017276EN Rev B 5 Cleaning and Sterilization Requirements FE Cleaning and Sterilization Requirements This chapter provides instructions for cleaning the Stellaris PC Vision Enhancement System and for cleaning and sterilization of the reusable accessories e Note Specific instructions for cleaning and sterilization included with any handpiece or accessory take precedence over these instructions Note Preventative scheduled maintenance is recommended once a year to insure that the Stellaris PC Vision Enhancement System meets its optimum performance reliability and safety standards set by the manufacturer The maintenance shall be done by a Bausch Lomb certified individual only A CAUTION Allow 20 minutes after sterilization for the handpiece and cord to cool before using them again The handpiece connector must be completely dry before it is connected it to equipment 5 1 Routine Cleaning A WARNING Disconnect AC power before clean
102. ancement System to establish or restore connections 3 26 Operator s Manual 110017276EN Rev B 3 Customizing Your System Irma Uc cc p aeos 3 8 Customization Levels The following tables detail which options can be customized at which levels Audio Visual Customization Level Options Ranges Step Sizes Eu Typewriter data entry 30 characters max Screen voice language English US English UK Czech Danish German Surgeon Greek Spanish Estonian Finnish French Hungarian Italian Dutch Polish Portuguese Romanian Slovak Swedish Simplified Chinese Japanese Korean Russian Display backlight brightness 20 to 100 by 10 System master audio volume 0 to 100 by 5 Tone selection and volume Irr Infusion No tone Tone 1 Tone 10 Surgeon control 0 to 100 by 5 Vacuum No tone Tone 1 Tone 10 0 to 100 by 5 U S No tone Tone 1 Tone 10 0 to 100 by 5 Vit No tone Tone 1 Tone 10 096 to 10096 by 596 Visc and Timer No tone Tone 1 to Tone 10 096 to 10096 by 596 Key Tone 0 to 100 by 5 Coag Tone to Tone 10 20 to 100 by 5 Alert and Elev Infusion 20 to 100 by 5 Voice confirmation Enabled Disabled Surgeon Volume 0 to 100 by 5 Video overlay language English US English UK Czech Danish German Surgeon Greek Spanish Estonian Finnish French Hungarian Italian Dutch Polish Portuguese Romanian Slovak Swedish Simplified Chinese Japanese
103. anings of error messages service information and system specifications Make sure that you read and follow all safety precautions set forth in this manual Information presented in this manual relating to surgical procedures is a suggestion only and does not constitute any warranty of fitness or claim of responsibility or undertaking of liability resulting from any surgical techniques practiced The surgeon is ultimately responsible for determining the appropriate procedure for each patient A Note The user interface screens displayed in this manual may differ from what is on your system depending on configuration While the information is the same the depiction may change The illustrations should not be used in place of the instructions in the manual Symbols and Notes The following are general definitions of the symbols and precautions used on this equipment and in this manual Preface 2 Operator s Manual 110017276EN Rev B gt DANGER gt WARNING A CAUTION Preface SSS Calls attention to an operating procedure practice or condition which if disregarded or incorrectly performed could result in imminent explosion hazard and risk of death or serious injury Calls attention to an operating procedure practice or condition which if disregarded or incorrectly performed could result in serious and or permanent injury to personnel and or patients Calls attention to an operating procedure practice o
104. ant for the system are connected User Profile The Bausch Lomb Stellaris PC Vision Enhancement System is intended for use only by qualified physicians and nurses Contraindications Use of accessories not designated by Bausch Lomb for use with this equipment may result in serious permanent patient injury adverse surgical outcome or damage to the equipment which may not be covered by warranty See page 1 1 for precautions relevant to patients with implantable defibrillators and cardiac pacemakers This manual contains precautions Danger Cautions Warnings Notes etc throughout that should be observed when using this equipment For safety s sake please heed these precautions Patents The Bausch Lomb Stellaris PC Vision Enhancement System is covered by the following patents 5 331 951 5 370 602 5 388 569 5 910 139 5 964 746 5 991 142 6 045 527 6 055 458 6 081 122 6 083 195 6 106 512 and 6 203 516 additional patents pending Foreign and other patents may also apply Trademarks Bausch amp Lomb Stellaris TruLink and Storz are trademarks of Bausch amp Lomb Incorporated The Bluetooth word mark and logos are owned by the Bluetooth SIG Inc Other brands and product names used are trademarks of their respective owners 110017276EN Rev B Operator s Manual Preface 1 Preface Power Outputs COAG U S 100 0 Trainin Following ng installation at a surgical
105. anual 110017276EN Rev B 3 Customizing Your System SSS SE SSS SST Parameter Options Ranges Step Sizes Ce Pitch function for dual linear Vacuum limit Flow Phase Case flow aspiration modes Foot control mapping for Linear Front Loaded Back Loaded Phase Case yaw function linear control in dual linear aspiration flow modes Pressurized infusion Enabled Disabled Technique displayed Anterior Domain Only Pressurized infusion Pump On Off Pressurized infusion Pressure 0 mmHg to 20 mmHg by 2 mmHg Technique 20 mmHg to 150 mmHg by 5 mmHg tab Phase Case Infusion Units Posterior and mmHg and cmH O Surgeon Combined Domains Posterior Infusion Type Manual Auto On Auto On Off Ultrasound Options Ranges Step Sizes NEN Ultrasound Modulation Type Continuous Phase Case Pulsed Single burst Fixed pulse Multiple burst Linear Power Linear Pulse Linear Power Linear Duty Cycle Dual Linear Multiple Burst Variable Power Multiple Burst Variable Power Linear Burst Fixed power level or linear 096 to 1096 by 196 Phase Case power maximum level 1096 to 3096 by 296 3096 to 10096 by 596 Pulse rate for pulsed modes 0 PPS to 20 PPS by 1 PPS Phase Case 20 PPS to 50 PPS by 5 PPS 50 PPS to 250 PPS by 10 PPS Subject to minimum on time of 2 ms and a minimum off time of 2 ms Duty cycle fixed or 596 to 9596 by 596 Phase Case maximum for pulsed modes Subject to minimum on time of 2 ms and a minimum off time of 2 ms Burs
106. arent reprocess the Stellaris PC Vision Enhancement System s Ultrasound handpiece as indicated above 110017276EN Rev B Operator s Manual 5 13 5 Cleaning and Sterilization Requirements 5 6 Cleaning the MMC A CAUTION To preserve the chassis finish avoid the use of abrasive cleaners If possible clean spots before they dry WARNING Disconnect AC power before cleaning the chassis The following cleaning solutions are recommended to clean the MMC e Isopropyl alcohol 70 Mild soap and water Wipe the area to be cleaned using a soft cloth moistened with cleaning solution Avoid excessive quantities of cleaning solution around the open vents on the MMC outer chassis Remove all traces of the cleaning solution with a cloth dampened with clean water The surfaces should then be dried with a lint free cloth A periodic visual inspection of the system components should be performed to inspect for damaged cables or connectors Store the MMC in a dry and clean area and avoid extreme temperatures There are no requirements for periodic calibration or adjustments 5 I4 Operator s Manual 110017276EN Rev B 6 Troubleshooting Troubleshooting This chapter contains procedures for identifying and resolving problems that may occur with your Stellaris PC Vision Enhancement System 6 1 User Troubleshooting e If the aspiration line becomes clogged and it cannot be cleared using reflux remove the handpiece from t
107. ave Save As and Cancel Zi buttons Selecting Save As allows you to save the new parameters to a particular surgeon technique gauge and fragmentation needle file If a setting has been changed in a More Screen the text will be blue instead of black to highlight the modification Once the change is saved the text will turn black 110017276EN Rev B Operator s Manual 2 47 2 User Interface Figure 2 53 Setup with Linear Coagulation More Settings Screen Coagulation tab 2 48 Operator s Manual 110017276EN Rev B 2 User Interface IEN Figure 2 54 Setup without Linear Coagulation More Settings Screen Infusion tab 110017276EN Rev B Operator s Manual 2 49 2 User Interface Figure 2 55 Anterior Vitrectomy More Settings Screen Cut tab 2 50 Operator s Manual 110017276EN Rev B 2 User Interface Figure 2 56 Phaco More Settings Screen Ultrasound tab 110017276EN Rev B Operator s Manual 2 51 2 User Interface Figure 2 57 I A More Settings Screen Infusion tab 2 52 Operator s Manual 110017276EN Rev B 2 User Interface JEE Figure 2 58 Irrigation More Settings Screen Infusion tab 110017276EN Rev B Operator s Manual 2 53 2 User Interface Figure 2 59 Linear Coagulation More Settings Screen Coagulation tab 2 54 Operator s Manual 110017276EN Rev B 2 User Interface EH The Aspiration Tab shows the current mode vacuum settings vacuum response setting venting m
108. ave been re sent to y SG04 Call your product service the module am representative if this problem persists SG05 Call your product service The vacuum fluidics module does not i LUE a VFMO5 Warning have valid factory calibration data S306 Call your produchasteied Surgical mode is not available e representative to replace or calibrate the vacuum fluidics module The vacuum fluidics module cassette SG13 Please wait for the vacuum fluidics VFMO07 Info 2m vacuum check is in progress module cassette vacuum check to complete SG11 Re insert the cassette for the cassette vacuum check VFM08 Info The cassette vacuum check has failed SG15 Replace the cassette SG04 Call your product service representative if this problem persists VFMO09 System priming has not been completed SG Select Sp ae Fane 0 complete the system priming VFMIO Besteet SG21 Please wait for the system priming to complete SG22 Check irrigation and aspiration tubing connections for leaks Check that the test chamber is forming a tight seal around the handpiece Try priming the VFMII Info System priming has failed system again SG23 Eject the cassette load a new pack and try priming the system again SG04 Call your product service representative if this problem persists 110017276EN Rev B Operator s Manual 6 13 6 Troubleshooting VFMI3 Info Warning VFM14 VFMI5 Warning n Text Message Suggested Action s
109. ayed option will bring up a list Only one option can be selected at a given time Selecting one option automatically deselects others Linear Inject Fixed Inject Dual Y aw Vac Linear Extract Fixed Extract Figure 2 2 Sample Option List 110017276EN Rev B Operator s Manual 2 1 2 User Interface Test Tube Display and Control This control allows you to set the upper and lower limits of a system parameter For a linear setting the maximum value is shown at the top of the tube and the minimum value is shown at the bottom of the tube The number in the middle of the tube shows the current value of that setting The maximum and minimum values for that parameter may be increased or decreased by selecting the up and down arrows next to each of the numbers respectively Figure 2 3 Sample Test Tube Display and Control for ranged parameters For a system parameter that has a fixed value instead of a range the value on the top of the tube will represent the current setting when that function is not active and the actual value when the function is active Arrows on the tube itself will allow you to increase or decrease the value of the parameter Figure 2 4 Sample Test Tube display for fixed value parameters 2 2 Operator s Manual 110017276EN Rev B 2 User Interface On Off Button A small on off button will be displayed on the screen near the function indicator A green ring around the button indicates the funct
110. below Cleaning times and conditions may be adjusted based on the degree of soiling present on the Stellaris PC Vision Enhancement System s Ultrasound handpiece The conditions indicated below were validated using a neutral pH detergent Getinge Neutrawash and a severe organic soil challenge BS 2745 Part 3 1993 The use of a neutral pH detergent solution is recommended to avoid damage to the Stellaris PC Vision Enhancement System s Ultrasound handpiece components Phase Time Temperature Pre Wash 3 minutes 30 C 86 F Wash 1 10 minutes 40 C 104 F Wash 2 10 minutes 30 C 86 F Rinse 3 minutes 30 C 86 F Heated Final Rinse 50 minutes at 80 C 176 F or 10 minutes at 90 C 194 F Drying By observation Do not exceed 110 C 230 F 1 Neutral pH detergent Adjust concentration according to the detergent manufacturer s directions regarding water quality and the extent of instrument soiling 2 Minimum exposure conditions for thermal disinfection using purified water 3 As cleaning frequently involves mixed instrument loads the efficacy of drying will vary based on the equipment employed and the nature and volume of the load being processed Therefore the drying parameters selected must be determined by observation 5 Following processing carefully inspect the Stellaris PC Vision Enhancement System s Ultrasound handpiece for cleanliness any evidence of damage and proper operation If residual soiling is app
111. bipolar handpieces and cables designated by Bausch Lomb for use with this system Failure of HF surgical equipment could result in an unintended power output increase The patient leads should be positioned in such a way that contact with the patient or other leads is avoided Temporarily unused bipolar handpieces should be stored in a location that is isolated from the patient The output power selected should be as low as possible for the intended purpose 4 46 Operator s Manual 110017276EN Rev B 4 Detailed Reference A Note For explanation of Dual Linear Foot Control see page 1 4 Bipolar coagulation is accomplished with the Stellaris PC Vision Enhancement System Coagulation Function Bipolar forceps or pencil handpieces are used as electrodes Coagulation power may be adjusted from 0 to 100 of the output power using the up down arrow keys The available coagulation modes are Fixed coagulation mode Provides an adjustable output between 0 and 100 Power levels are set via spin button control Fixed coagulation may be actuated by any Foot Control button if programmed Fixed coagulation remains activated as long as the button remains depressed Linear coagulation mode Provides an adjustable output between 0 and 100 Power levels are set via spin button control Linear Coagulation is selected from the clock menu on the Main Surgical Screen Linear coagulation is actuated by depressing the footpedal if it has been prog
112. both a Linear Cut Rate and a Fixed Cut Rate from 0 to 5000 cpm See page 4 5 for details of posterior use and page 8 17 for technical specifications Illumination Function The illumination function provides two light sources both with an adjustable attenuator More than 25 lumens output is available at maximum settings With a xenon lamp in Lamp 1 location any one of three color filters yellow green and amber may be used Both ports incorporate permanent filtration to reduce ultraviolet violet deep red and infrared light See page 4 11 for details of use and page 8 18 for technical specifications page 1 61 gives additional guidance on output setting Air Compressor The compressor provides air pressure to drive various pinch valves Pressurized Infusion Anterior domain Air Forced Infusion Posterior Combined domains and Fluid Air Exchange It also houses the air pump to drive the Viscous Fluid injection function and the venturi regulator for vacuum control See Chapter 8 for technical specifications IV Pole A WARNING Use of an IV Pole extension or other means of altering the bottle height may cause inaccurate setting displays resulting in serious permanent patient injury 1 36 Operator s Manual 110017276EN Rev B 1 Getting Started A WARNING This system is to be used in either air pressured infusion mode or IV Pole mode but never both together as high intraocular pressures may result CAUTION Do not manually force
113. cal Screen see Figure 1 14 for an example of an Anterior Surgical Screen and Figure 1 15 for an example of a Combined Mode Surgical Screen When the appropriate screen appears your Stellaris PC Vision Enhancement System is ready for the surgical procedure to begin Figure 1 13 Posterior Surgical Screen 110017276EN Rev B Operator s Manual 1 23 1 Getting Started Figure 1 14 Anterior Surgical Screen 1 24 Operator s Manual 110017276EN Rev B 1 Getting Started Figure 1 15 Combined Surgical Screen 1 7 Concluding a Surgical Procedure Select End from the clock menu Confirm that you are ready to end the case and eject the cassette and you will be reminded to close the clamps on the administration tube set A similar End function is accessible from the Setup Screen A WARNING Make sure to close the Irrigation Clamp on the Administration Tube Set before pressing End Procedure or fluid may continue to flow from the handpiece and into the cassette The system will then advance to the End of Case Screen shown below lower the IV Pole and eject the cassette 110017276EN Rev B Operator s Manual 1 25 1 Getting Started Dor om m Bausch Lomb EE Figure 1 16 Anterior End of Case Screen 1 26 Operator s Manual 110017276EN Rev B 1 Getting Started Figure 1 17 Posterior End of Case Screen 110017276EN Rev B Operator s Manual 1 27 1 Getting Started Figure 1
114. cc ml mark C Connect the end of the syringe to the irrigation fitting of the handpiece see Figure 5 2 D Push on the syringe plunger to force fluid through the handpiece into another beaker for proper disposal Do not draw flushing fluid back through the handpiece Disconnect the syringe Repeat Steps B through D at least three times Fill the syringe with air reattach to handpiece and push on the syringe plunger to force air through the handpiece Disconnect the syringe G Repeat Step F at least three times H Refill the syringe to the 50 cc ml mark with warm 30 C to 40 C or 85 F to 105 F distilled or deionized water I Connect the syringe to the center stopcock fitting J Rotate the stopcock lever to allow fluid flow to the female luer fitting K Connect the stopcock female luer fitting to the handpiece aspiration fitting 5 4 Operator s Manual 110017276EN Rev B 5 Cleaning and Sterilization Requirements L Push on the syringe plunger to force fluid through the handpiece into another beaker for proper disposal Do not draw flushing fluid back through the handpiece Disconnect the syringe M Repeat Steps H through L at least three times N Fill the syringe with air reattach to stopcock and push on the syringe plunger to force air through the handpiece Disconnect the syringe O Repeat Step N at least three times CAUTION Use only warm 30 C to 40 C or 85 F to 105 F distilled o
115. ce representative if this problem persists SOU Call your product service representative SG02 Call your product service representative A compatible software version must be downloaded SG04 Call your product service representative if this problem persists SG04 Call your product service representative if this problem persists The system requires restarting due to an internal error please perform the following 1 Select Close to initiate system shutdown 2 If system does not shutdown after 30 seconds power off the system by pressing and holding the power button at the front panel 3 Restart system after one minute Call your product service representative if this problem persists 110017276EN Rev B Operator s Manual 6 17 6 Troubleshooting Additional Troubleshooting Guide Symptom Potential Cause Corrective Action 1 Foot Control lost Pitch control of Region 2 3 and Yaw Pitch could only control Irrigation On Off The four side buttons function normally 2 Foot Control does not automatically transition to wireless operation after disconnecting the Foot Control backup cable 3 System not reading cassette fluid level correctly 6 18 Operator s Manual The Foot Pedal Offset switch not properly engaged System not detecting if foot pedal is offset to Left Right or Center 1 Pitch Tension Adjustment 2 Battery Door 3 Offset Adjustment The Foot Control does not automatically tra
116. ch is turned ON This charging method applies with or without the Graphical User Interface being turned ON See Option 1 in Figure 1 34 The Foot Control can be directly connected to the wall charger Connect the wall charger cable into the back of the Foot Control into the same receptacle used for the backup cable See Option 2 in Figure 1 34 110017276EN Rev B Operator s Manual 1 51 1 Getting Started E e With an extra battery and battery charging cradle you can connect the wall charger cable to the battery charging cradle A green light indicates the cradle is on a second light is yellow when charging is in progress and green when the battery charging is complete Once the battery is fully charged you can take it out of the cradle and replace the battery in the Foot Control See Option 3 in Figure 1 34 A Note When the Foot Control is connected to the wall charger it will not communicate with the system and cannot be used in surgery Note To connect the backup cable or wall charger to the Foot Control align the red dot of the connectors to the 12 o clock position Note The Foot Control is only to be used with wall charger BL4391 2 3 A A BL4391 BL4391 BL4393 Figure 1 34 Foot Control Battery Charging Options 1 Using Foot Control back up cable 2 Using wall charger BL4391 3 Using charging cradle BL4393 A Electrical Power Source Note The battery charging cradle MUST be connected to the wall charger
117. ch the maximum setting if the air tubing is not connected to the air output connector The air pump can only be turned off using the M4 More Settings Screen When the infusion type is Air Forced Infusion the infusion pressure unit of measurement display can be toggled between cmH2O and mmHg Pressing the display unit button will change the displayed unit of measure 110017276EN Rev B Operator s Manual 2 39 2 User Interface E Ultrasound Coagulation or Viscous Fluid Control VFC The lower right corner displays either the Ultrasound or VFC status depending on which mode is currently selected from the clock menu The current setting is shown on the top of the test tube with a green background for ultrasound and an aqua background for VFC The actual value is displayed in the middle of the test tube When ultrasound is active an option list control appears in the lower right corner and selecting the small x allows you to select from a list of pre programmed ultrasound submodes If you select pulsed ultrasound the pulse per second PPS and duty cycle DC spin controls appear if the display option button is selected Footpedal and Coagulation The current footpedal status is displayed in the bottom center of the screen The current pitch region 1 2 or 3 is shown and the circles around the top indicate yaw position See the chart on page 1 59 for details on Foot Control setup If one of the Foot Control Buttons has been prog
118. chsLomb BauschsLomb Stellaris PC Stellans Foot Contra ud Bausch amp Lomb Incorporated Rochester NY 14609 U S ec rer Bausch amp Lomb Incorporated Kingston upon Tharnes h amp Lomb incorporated KT2 6TN UK X b CE 1275 Use only with BL4391 REF BL2390 Dp 100027076 NN SN WFCxxxxx CCYY E Mace in GERMANY LI 777 36V FCCID T7v BCOG Grantee Code UMT BT REMOTE TERT AM I 0100757770480821 00 RODER TU 21xxx00000 01 5000586 Rey E Main System Label Foot Control Label Bausch amp Lomb Incorporated E Bausch amp Lomb Incorporated itil Rochester NY 14609 US A 106 London Road CE 275 Made in U S A A Kingston upon Thames W AN KT2 EIN UK 2xAA EZ 3v A 015000587 Rev A Large Remote Control Label REF BL2111 SN REM oox 101028117 TE 12 Au NN IT IAL nie OI 20V 1000 V 21 REM ooo ie Re 5 Small Remote Control Label System Power and Fuse Label nft REF BL4390 auschslomb CP gt 400027051 u Rechargeable Li ion Battery SN SSSSS x Bausch Lamb Bausch amp Lomb z Rochester NY 14803 usa a PR Rechargable Li ion Battery Bausch amp Lomb Incorporated aw jraruew Lei KNU A RDA Rea REF BL4380 3 6V 015000635 Rev A EERE 36 VOC PESE 2250 mAh Foot Control Battery Label Foot Control Battery Compartment Label 110017276EN Rev B Operator s Manual 8 19 8 Specifications XENON MERCURY 015000626
119. collection container through the attached tubing Vitrectomy Cutter Modes The Stellaris PC Vision Enhancement System provides four vitrectomy cutter modes as described below The cut rate may be adjusted from 30 to 5000 cpm with increments as shown in the table below or to any specific value using the keypad Range Jeep size 30 to 100 cpm 100 to 1000 cpm 1000 to 5000 cpm 100 cpm e Note Vitrectomy cut rate derating above 915 meters 3000 feet altitude can be compensated with increased input pressure not to exceed 6 9 bar 100 PSIG Fixed Cut Fixed cut is a single region pitch control mode and vitreous cutting is activated the moment footpedal is depressed The cut rate is fixed Vacuum is proportional to footpedal depression Each successive outward yaw movement of the footpedal toggles the cutter ON or OFF If enabled an audible tone will indicate cutter on double beep or cutter off single beep By default the vitrectomy cutter is ON aal Figure 4 1 Single region pitch control Fixed cut linear vacuum Dual Linear Cut Dual Yaw Cut Dual Linear cut uses two region pitch and yaw control Pressing the footpedal downward into Region 1 is necessary to activate cutting with outward yaw Outward yaw while in Region 1 activates cutting without 110017276EN Rev B Operator s Manual 4 5 4 Detailed Reference vacuum Linear control of the cut rate is a function of footpedal yaw displacement Further depressing the f
120. cover before use 4 24 Operator s Manual 110017276EN Rev B 4 Detailed Reference Figure 4 17 Viscous Fluid Injection Setup 1 Viscous Fluid Port 2 Air Tubing Connector 3 Coupler 4 Piston 5 Syringe with Silicone Oil 6 Syringe Cap 7 19g Injection Cannula for injection 8 19g Extraction Cannula Viscous Fluid Injection Operation Modes Fixed Fluid Injection The footpedal is used to control the injection with a pre programmed fixed pressure The pressure level is set using the spin buttons on the touch screen Linear Fluid Injection Control of linear fluid injection is via the footpedal The injection pressure increases proportional to footpedal travel from the minimum programmed setting to the maximum programmed setting The minimum and maximum pressure levels are set using the touch screen Dual Yaw Vac Linear Fluid Injection Linear Vacuum Linear fluid injection is actuated by depressing the footpedal Linear aspiration through the left aspiration line is actuated by an outward yaw movement of the center footpedal The minimum and maximum pressure levels are set using the touch screen Extraction 1l Open a CX5710 disposable pack and place contents on a sterile surface 2 Connect the locking air connector on the tubing set to the Stellaris PC system Top right connector Figure 1 22 110017276EN Rev B Operator s Manual 4 25 4 Detailed Reference 3 Remove the syringe cap item 6 of Figure 4 20
121. culating Nurse The system will not provide feedback as to whether or not fluid is present during priming Inspect tubing and confirm that it is filled with fluid and free of bubbles after each Prime and Tune Repeat the priming process if the tubing is not adequately filled with fluid The posterior section setup is now complete The following steps are to setup the anterior functions Remove the second aspiration line from the priming cup and connect to the phaco handpiece Remove the irrigation line from the 2 way stopcock and connect it to the phaco handpiece See Show Me Steps for animated setup guide if necessary Operator s Manual 110017276EN Rev B 12 13 14 15 16 17 4 Detailed Reference Figure 4 33 Connecting tubing to the phaco handpiece 1 Phaco Handpiece 2 Phaco Needle 3 Infusion sleeve 4 Test Chamber 5 Connect to U S connector 6 Connect to Vit actuation port 7 Connect to air pressure port Plug the handpiece connector to the machine Second connector from the top Thread and firmly secure the ultrasound needle onto the ultrasound handpiece using a needle wrench Thread the irrigation sleeve over the ultrasound needle so that the holes in the irrigation sleeve are placed approximately 1 mm from and perpendicular to the bevel of the ultrasound needle increase to approximately 1 5 mm for denser cataracts Toggle the Irrigation Off button to turn flow on and
122. d 1 Left Toe Button 2 Footpedal 3 Right Toe Button 4 Right Heel Button 5 Right LED Wireless 6 Left LED Battery 7 Left Heel Button There are two lights on the Foot Control itself The light on the right indicates that the wireless connection on the Foot Control is active This light will flash until communications are established with the system When the light is non flashing green the Foot Control is ready to be used wirelessly The light on the left indicates battery status as described in the table below color Status More than one hour of battery life remains 110017276EN Rev B Operator s Manual 1 53 1 Getting Started color Status Red and Blinking Less than one hour of battery life remains Basic Button Operation A Note Voice confirmation if enabled responds to Foot Control and remote control operation For surgical phase changes voice confirmation also will be activated if changes are made through the touch screen All four buttons on the Foot Control are user programmable They are initially set in the surgeon preferences file and can be modified either through the programming interface see Chapter 3 or in some cases through the Foot Control More Setting Screen see page 2 24 The Foot Control More Settings Screen is used to convey the current footpedal configuration and status to the surgical team In anterior domains it is displayed by selecting the Foot Control More Button
123. d Infusion Units cm H O mmHg Infusion Pressure elevated infusion elevated F AX lluminators Tab Upper lamp on off and percent on lower lamp on off percent on and filter none amber green yellow For posterior techniques the Irrigation Delay setting will not be displayed 3 6 Operator s Manual 110017276EN Rev B 3 Customizing Your System E For combined techniques Infusion Type Infusion Units F AX pressure Infusion pressure Elevated Infusion pressure and Elevated F AX pressure settings are displayed They are not displayed in anterior modes For anterior techniques the IN Pole Height setting Pressurized Infusion pressure setting and Pressurized Infusion Display setting are displayed e A V Tab Display Format 1 or 2 Status Bar Format 1 2 3 Remote Control Enable Disable For posterior techniques the A V tab is not available For combined techniques status bar format and preview are available For anterior techniques display format display format preview and status bar format are available Customizing Phases and Exceptions Both Phases and Exceptions can be reordered and customized Select a phase or exception from the list on the appropriate tab and the Customize button will appear e Note The total number of surgery phases normal and exception cannot exceed 12 There must at least one normal phase in each technique and there can be no more than 8 exceptions 110017276EN Rev B O
124. d cut vitrectomy function Figure 1 36 Single Region Pitch Control Two Region Pitch Control There are two programmable regions two detent positions When programmed for linear control the pitch movement is a function of relative footpedal displacement in Region 2 e g 5 to 15 down corresponds to 096 to 100 output An example is I A control where Region 1 is for irrigation and Region 2 is for linear vacuum or flow Figure 1 37 Two Region Pitch Control 110017276EN Rev B Operator s Manual 1 55 1 Getting Started Three Region Pitch Control There are three programmable regions three detent positions When programmed for linear control pitch movement is a function of relative footpedal displacement as shown below An example is single linear ultrasound phases where Region 1 is irrigation Region 2 is fixed aspiration and Region 3 is linear ultrasound power Figure 1 38 Three Region Pitch Control Programmable Yaw Positions The Foot Control may be set and programmed to give greater linear yaw movement for either right or left foot operation Turn the Foot Control over and adjust the Pedal Offset Switch to the left or right for preferred direction e Set and programmed for a right footed operator with the pedal home position offset to the left of center by approximately 5 to give approximately 15 of motion to the right and approximately 5 of motion to the left See Dual Linear Yaw Control below
125. d ensure that it is recycled in a manner that protects both human health and the environment For more information about where you can drop off your waste equipment for recycling please contact your local recycling office or electronic waste hauler 1 50 Operator s Manual 110017276EN Rev B 1 Getting Started O ee AN CAUTION Do not expose the battery to any fluids The battery when fully charged will last for 12 hours You may rely on a single battery or choose to keep one charging in a battery charging cradle BL4393 while the other battery is being used Figure 1 33 Foot Control Battery Charging Cradle Battery Charging Options e Note The battery should be removed from the Foot Control if the system is to be idle for more than seven days Note To maximize performance the Foot Control batteries BL4390 should be rotated every two months Upon removal battery must be charged before it is stored Note Use only Bausch Lomb supplied wall chargers BL4391 charging cradles BL4393 adapters BLA392US BLA392UK BL4392EU BL4392AUS BLA392ROW and batteries BL4390 with the Stellaris PC Vision Enhancement System The Foot Control Battery should be charged whenever the system is not in use Any one of three methods can be used to charge the battery With the system power cord plugged in to the electric source and the Foot Control connected to the system the battery will be charged if the main power swit
126. d overwrite existing files and No to discard your changes 3 2 Operator s Manual 110017276EN Rev B 3 Customizing Your System En c RlT 3 1 Manage Settings Select Surgeon Settings from the Main Programming Screen and a new screen will appear through which you can customize an existing surgeon s file create a new surgeon preference file by copying from an existing one backup files restore files from a backup or delete surgeon preference files Figure 3 2 Surgeon Settings Screen Customize a Settings File To change the settings for a currently existing preference file select the Customize Tab on the Main Programming Screen A list of all surgeon preference files currently loaded on your Stellaris PC Vision Enhancement System will appear Select the name of the surgeon file to be modified then select Confirm The Surgeon Programming Screen appears with the file name along the left side of the screen and seven tabs across the top see page 3 6 These tabs are Profile Technique Foot Control Fluidics A V and Video Overlay Each tab allows you to make global changes to system parameters and is described in detail below 110017276EN Rev B Operator s Manual 3 3 3 Customizing Your System u System parameters can be customized at different levels Global settings take place at the Technique Level Technique level settings can be overridden at the phase level See the table on page
127. default surgeon applies to the full day or if separate defaults will be applied to the morning and afternoon of that weekday Select lt or toggle between full day or morning and afternoon settings The third column contains option lists with the names of all the surgeon preference files currently available Select a file from the list and that will be the default file when the Stellaris amp PC Vision Enhancement System starts up at that time In the fourth column select how many rooms that surgeon operates in and in the fifth column select in which room number this Stellaris PC Vision Enhancement System is located These settings determine how the case numbers will be incremented to avoid duplicate case numbers for a single surgeon The Default Procedure pull down menu at the bottom of the screen allows you to select the default mode for the system The Default Procedure setting Rooms column and This Room column are not displayed in posterior only configuration systems 110017276EN Rev B Operator s Manual 3 23 3 Customizing Your System 3 7 TruLink Customer Support Network A WARNING You must contact your local Bausch Lomb sales and support office before activating the TruLink Customer Support Network function See Technical Assistance on page 7 1 for the sales and support office that serves your location WARNING Do not conduct surgery or any patient procedures while TruLink Customer Support Network
128. des a detailed reference for each system function and accessory A WARNING Do not use in the presence of flammable anaesthetics disinfectants aerosol sprays or in an oxygen rich atmosphere WARNING The use of high infusion pressure may cause damage to the eye It is the user s responsibility to ensure use of appropriate infusion pressure during the surgery Note Ensure tube set connection is secure when connecting to the handpiece and system 4 1 Advanced Vacuum System Fluidics A WARNING For optimum aspiration and reflux performance the patient s eye level must be at the same level as no more than 7 cm 3 in from the Stellaris PC Vision Enhancement System aspiration port Failure to follow this procedure may result in serious and permanent patient injury The advanced vacuum fluidics creates aspiration using a venturi system driven by compressed air which is connected to the machine by an air hose With your Stellaris PC Vision Enhancement System the irrigation line from an inverted bottle of balanced salt solution BSS is integrated into the tubing manifold at the top part of the vacuum cassette The delivery pressure of the BSS is adjusted by varying the height of the bottle in relation to the patient s eye or by air pressure injected into the bottle when Pressurized Infusion or AFI is used On off control of irrigation is accomplished through the touch screen interface or by the Footpedal for Anterior mod
129. disabled or the Fluid Air Exchange level is reduced below the tamponade level a voice confirmation will sound and the timer will be cleared from the screen When Elev Inf is toggled off the air pressure and I V pole will be set to the value it had prior to turning Elev Inf on and the timer will be cleared from the screen To program the Elevated infusion pressure for Air Tamponade and Fluid Tamponade go to the Technique programming level Fluidics tab to set desire pressure see page 3 5 By default the pressure is set at 80 mmHg and 100 cm 4 22 Operator s Manual 110017276EN Rev B 4 Detailed Reference ne em s Figure 4 16 Technique programming level Fluidics screen with Air and Fluid Tamponade settings Viscous Fluid Control VFC Posterior Only A WARNING The Viscous Fluid Control is not intended for aspiration of balanced salt solution A WARNING Subretinal cannulas are not intended for aspiration of viscous fluid or balanced salt solution The Stellaris PC Vision Enhancement System s Viscous Fluid Control function generates the required injection pressures and aspiration vacuums for injecting viscous fluids to and aspirating viscous fluids from the eye during posterior segment surgery The Viscous Fluid function will deliver up to 72 5 psig 500 kPa 5 0 bar of pneumatic pressure to the disposable tube set All other posterior system functions except fragmentation and vitrectomy may be operated simultaneously o
130. e Figure 3 7 Customize Foot Control Screen 3 10 Operator s Manual 110017276EN Rev B 3 Customizing Your System Customize Fluidics To set the parameters for Fluidics functions select the Fluidics Tab from the Surgeon Level Programming Screen You can set the BSS Bottle Type Patient Eye Level relative to the aspiration port on the fluidics system Ultrasound Needle Type I A Tip Type Vit Tip Type and Frag needle by selecting the from the drop down menu that appears for each variable Figure 3 8 Customize Fluidics Screen 110017276EN Rev B Operator s Manual 3 11 3 Customizing Your System Customize A V Audio Visual To set the parameters for audio and visual functions select the A V Tab from the Surgeon Level Programming Screen You can adjust both Display Brightness and Master Volume by using the spin controls on this screen To change the tone or volume of a tone that is sounded for a particular condition select the function from the list at the bottom of the screen and that condition will appear in the change section in the middle of the screen Select the desired tone from the option list and use the spin control button to increase or decrease the volume A Note Only tones that are not currently in use by another function will be available for selection en Im amp mes cem or mex pose LEE M Figure 3 9 Customize Audio Visual Settings Screen 3 12 Operator s Manual 1100
131. e 1 40 you may use wireless communication 110017276EN Rev B Operator s Manual 1 9 1 Getting Started Note The out of factory Wireless System Setup is Disabled Software upgrade will also reset the Wireless System Setup to Disabled See System Setup Instructions on page 1 46 to configure Foot Control to wireless operation If you are going to use the Foot Control in wireless mode ensure the Foot Control battery is charged then hold down any button on the Foot Control until the green ready light comes on indicating that communication has been initiated This light will turn solid green when full communications have been established When the system check is completed following system power up the Splash screen will appear See Figure 1 5 on page 1 10 Note Following system shut down wait a minimum of 15 seconds before restarting the system The system is fully shut down after the front panel power button light changes from dim to bright BauschsLomb Stellaris27 Figure 1 5 Opening Splash Screen 1 10 Operator s Manual 110017276EN Rev B 1 Getting Started Once the software has finished loading the Select Procedure screen will appear as shown below Figure 1 6 Select Procedure Screen A Select Surgeon Screen as shown in Figure 1 7 on page 1 12 will appear when you select any type of procedure from the Select Procedure Screen If your system is programmed to default to either the Anterior D
132. e completion of travel e Note Due to compliance with IEC 60601 2 2 position 1 will not start until approximately 35 of pedal travel is attained in the linear coagulation mode 1 58 Operator s Manual 110017276EN Rev B 1 Getting Started Center Foot Control Phase Type Dual Linear Region Yaw Out Control RS Next submode R3 o Linear ultrasound Aspiration R2 Disabled with minimum to fixed Next aspiration control vacuum or vacuum Ss submode feature on limit Irrigation Fixed aspiration amp linear ultrasound reien Minimum Li ots inear aspiration _ 0 aspiration Linear ultrasound R2 Aspiration R2 Aspiration on minimum to fixed yaw amp aspiration vacuum or vacuum To max control feature on limit aspiration Min aspiration and linear ultrasound RI Dieter MEM Aspiration on Pitch m Linear aspiration ultrasound Er mus Ultrasound Linear U S Linear Function Ultrasound qu isable Irrigation Only Disabled Irrigation FP Aspiration on yaw Ultrasound RI R2 R3 RI R2 R3 RI R2 R3 RI R3 RI R2 110017276EN Rev B Operator s Manual 1 59 1 Gettin ee EE Started Phase Type Dual Linear Region Yaw Out OANA Hines Aspiration on off amp fixed vitrectomy when on Vitrectomy Aspiration on Pitch R2 Linear Aspiration Linear pue RSR EE Aspiration on Yaw R2 Linear Vitrectomy Aspiration Linear Aspiration Disabled Fixed a
133. e emitted The time interval between bursts is controlled by the linear control position of the footpedal When the pedal reaches full travel in the linear control the ultrasound energy is limited by the Max Duty Cycle setting BD nani 2 gt Figure 4 24 Multiple Burst Mode Ultrasound 1 Multiple Burst 2 Pedal Position 3 Power Ultrasound Submode Up to three sets of ultrasound modulation settings may be stored with each ultrasound mode Foot Control activation of the submode sequence may be enabled or disabled Submodes can be toggled with the Foot Control heel switch or by footpedal outward yaw motion in Region 2 or 3 depending on how the system has been programmed The options to change submodes with the Foot Control are Either the left side button pair or the right side button pair may be grouped to change submodes to the next submode toe or previous submode heel Any of the four Foot Control buttons may be assigned to advance to the next submode when ungrouped The outward yaw switch may be enabled to advance to the next submode in any region for single linear modes The inward yaw switch may be enabled to advance to the next submode in any region for dual linear modes with reflux disabled e The inward yaw switch may be enabled to advance to the next submode in Region 2 3 for dual linear modes with reflux enabled Ultrasound Tuning The ultrasound handpiece must be tuned with the needle in
134. e observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the Stellaris PC Vision Enhancement System b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 110017276EN Rev B Operator s Manual 8 7 8 Specifications _ 551555525 22Z Recommended separation distances between portable and mobile RF communications equipment and the Stellaris PC Vision Enhancement System The Stellaris PC Vision Enhancement System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Stellaris PC Vision Enhancement System as recommended below according to the maximum output power of the communications equipment Rated maximum Separation distance according to frequency of transmitter metres m output power of 150 ps to 80 MHz 80 in to 800 MHz 800 rs to 2 5 GHz transmitter W 12 p 124P MP For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the t
135. e page 4 37 Planned Anterior Vitrectomy See page 4 40 e Unplanned Anterior Vitrectomy See page 4 41 Coagulation Fixed Coagulation See page 4 47 Linear Coagulation See page 4 48 Combined Domain See page 4 50 A Note Fragmentation uses the same power connection as the ultrasound handpiece Only one function can be used at a time Note If a linear coagulation in set up is enabled or a Foot Control button is programmed for coagulation begin by plugging in the coagulation cord For on screen instructions select Show Me Steps from the Prime and Tune Screen and a tabbed screen will appear detailing the required steps and showing animations of how to perform each step 1 18 Operator s Manual 110017276EN Rev B A 1 Getting Started Gaa WARNING The animations illustrate the steps but do not represent sterile technique 4 Prime and Tune e Note The system will not provide feedback as to whether or not fluid is present during priming Inspect tubing and confirm that it is filled with fluid and free of bubbles after each Prime and Tune Repeat the priming process if the tubing is not adequately filled with fluid When the cassette has been inserted and captured by the machine and all accessories tubing and handpieces have been connected the system is ready for Prime and Tune To proceed to the Prime and Tune phase select the appropriate options for the domain in which you are operating Available opti
136. e touch screen the remote control or the Foot Control buttons if programmed In I A mode irrigation is activated in Region 1 of footpedal travel and both irrigation and aspiration are activated in Region 2 of footpedal travel Capsule Polish The capsule polish function is typically accomplished with a lower vacuum setting than standard settings These settings may be customized to allow quick entry into a lower vacuum level as explained in Chapter 3 Viscoelastic Removal The viscoelastic removal function provides different settings for the doctor s convenience These settings may be customized to allow quick entry into a specific vacuum level as explained in Chapter 3 Venting The Vacuum Flow Fluidics system provides the surgeon with either air or fluid venting options to free an occluded tip when the footpedal is released When air venting is selected the residual vacuum is vented to atmospheric pressure and when fluid venting is selected it is vented to a positive pressure equal to the bottle height head pressure Venting automatically occurs every time the Footpedal travels back to region 1 Reflux Aspiration of fluid to the collection cassette occurs via the handpiece and a tube set Reflux applies a momentary reverse pressure through the aspiration line to clear the aspiration port of lodged material The Stellaris PC Vision Enhancement System is designed for use with continuous reflux or pulse reflux If enabled the ref
137. eight preset height or the maximum the IV Pole is allowed to reach The maximum IV Pole height should be set when installing the Stellaris PC Vision Enhancement System in a particular medical facility You can do this using the programming interface see Chapter 3 Remote Control Anterior Domain Only Optional Accessory A CAUTION The remote control is not waterproof and is not sterilizable The remote control must be placed in a sterile cover prior to use in the sterile field The remote control transmits an infrared signal to a receiver at the bottom of the touch screen For critical functions you can activate a command directly through the remote control The commands which may be given from each remote control button are shown in Figure 1 23 on page 1 38 The remote control is powered by two AA batteries which should be replaced when the low battery light comes on Access the remote control batteries by removing the battery cover on the back of the remote 110017276EN Rev B Operator s Manual 1 37 1 Getting Started Figure 1 23 Remote Control functions 1 Low Battery Light 2 Transmitting Signal Light 3 Next Phase 4 Bottle Height 5 Phaco Vitrectomy or Coagulation 6 Up and Down 7 Flow 8 Vacuum 9 Previous Phase 10 Enter 11 Reserved for Future Use In the anterior domain the remote control can be used to activate functions in the Prime and Tune window of the setup screen The remote control
138. electing Infusion Pump to On will automatically activate the air pump whenever the surgeon file is selected for surgery For Combined Domain Only 6 Pressurized Infusion settings and function could be saved with Case More Settings Screen Pressurized Infusion Setup 1 Remove the filter cap A from the bottle spike venting port that comes with the system disposable pack in Figure 4 28 Connect the Air Tubing Line male connector to the bottle spike venting port A in Figure 4 28 Connect the Air Tubing Line filter to the microsurgical system air source B in Figure 4 28 Spike and hang the bottle on the hanger at the desired bottle height Use the up and down arrows to select the desired air pressure DN A Zei I Turn On the air pump by selecting Off button below the setting display Selecting the same button will turn off the pump 110017276EN Rev B Operator s Manual 4 45 4 Detailed Reference sm A Figure 4 28 Pressurized Infusion Setup The Pressurized Infusion air pump could be programmed to default pump status to On If programmed to default On the pump will turn on automatically when the surgeon technique file is selected 4 4 Coagulation Function Posterior amp Anterior Modes A WARNING A WARNING A WARNING A WARNING E Note Check the coagulation power level when changing between extraocular and intraocular cauterization Use only
139. eless System detecting No action required Moderate signal strength 110017276EN Rev B Operator s Manual 1 49 1 Getting Started Display Type Foot Control Setup status Action Wireless System detecting Low No action required signal strength Connect Foot Control System lost wireless backup cable to resume connection signal during operation procedure System will Note automatically configure System will remain in Wireless System to wired operation wired configuration disabled wireless setup The icon remains the next time system until connected with is powered up To Foot Control cable or configure system to manually re configures wireless operation see system to wireless section on Wireless Foot configuration Control System Setup page 1 46 Note Irrigation or infusion will be turned ON and other functions will be disabled when the system does not detect Foot Control connectivity in surgical mode Irrigation or infusion can be turned OFF from the touch screen Battery Management This symbol on the battery indicates that the product must be disposed of separately and safely Therefore it is your responsibility to dispose of this waste equipment by handing it over to a designated collection point or organization that specializes in the recycling of waste electrical and electronic equipment The separate collection and recycling of waste equipment at the time of disposal will help conserve natural resources an
140. em using the spin control on this screen This setting is to allow the system to be programmed to not hit the ceiling in a facility with ceilings lower than nine feet 2 75 meters ana _ Figure 3 17 Room Assignment Screen 3 20 Operator s Manual 110017276EN Rev B 3 Customizing Your System En ee Foot Control To change the way you Stellaris PC Vision Enhancement System connects to the Foot Control select the Foot Control Tab at the top of the System Setup Screen Select Enabled or Disabled to configure the connection mode Cone amp Enabled P Figure 3 18 Foot Control Connectivity Screen 110017276EN Rev B Operator s Manual 3 21 3 Customizing Your System 3 5 System Configuration To see a detailed listing of the software and hardware configurations of your system select System Configuration from the Main Programming Screen Figure 3 19 System Configuration Screen 3 6 System Calendar To set up your system to default to certain surgeon preference files and room numbers at certain times of the week select System Calendar from the Main Programming Screen and the System Calendar Screen will appear with four user editable columns 3 22 Operator s Manual 110017276EN Rev B 3 Customizing Your System _ m ne Figure 3 20 System Calendar Screen The second column next to the listing of the days of the week determines if the
141. ement System includes filters to remove the unwanted infrared from the light output but the visible light also contributes to the heat absorbed by the retina ISO15004 2 2007 advises limits to the thermal power density received by the retina in W per cm Unlike photoretinitis these limits are not time related With the high intensity output of the Stellaris PC it is possible to exceed these limits with a focal probe at 10046 output level with the probe close to the retina Color filters For the lamp in position 1 the user may select one of three color filters that tint the light output to give improved visualization in certain circumstances according to surgeon preference The current pre installed filter colors in the Stellaris PC illumination module are green yellow and amber Additional color options may become available later and at customers request can replace any or all of the current colors with new ones as desired 1 64 Operator s Manual 110017276EN Rev B 1 Getting Started E 1 14 Multimedia Center MMC optional The Multimedia Center MMC is used to overlay the surgical parameters output from the Stellaris PC Vision Enhancement System to the video image of the surgical site captured by the operating microscope camera The combined image is output to a video monitor and or a video recorder to be displayed and stored for future use The MMC is NOT intended for diagnostic purposes Installation Assure all equipmen
142. entify loose components from the pre connected tubing set Scrub Nurse Drape the system tray and screen with drapes provided Scrub Nurse Arrange the pre connected tubing set with cassette bottle spike air tubing filter and actuation connector toward the system front The priming cup is placed at the other end with the tubing set in the middle as shown in the figure below Scrub Nurse Figure 4 4 Pre connected Tubing set arrangement to facilitate setup Remove the tape to unbind all the tubing Scrub Nurse Straighten the tube set and secure it so it will not drop off the sterile surface Scrub Nurse Remove the tape from the cassette to release the additional tubing that is tied to the cassette Scrub Nurse Connect the air tubing filter to the system Second right connector Ensure the air pump is on Scrub Nurse or Circulating Nurse 4 8 Operator s Manual 110017276EN Rev B 4 Detailed Reference pecu o k Connect the vitrectomy actuation line blue stripe to the system Scrub Nurse or Circulating Nurse l Insert the fluidics cassette all the way in and hold until it is automatically captured by the system The cassette housing backlight will stop blinking and remain on when the system captures the cassette Scrub Nurse or Circulating Nurse m Pass the bottle spike and irrigation tubing to Circulating Nurse Scrub Nurse n Spike and hang the BSS bottle on the automated I V pole or
143. eparation distance calculated from the equation applicable to the frequency of the transmitter Recommended Separation distance d P Conducted d JP 80 Mhz to 800 MHz Radiated d P 800 Mhz to 2 5 GHz Radiated Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Ki Note At 80 MHz and 800 MHz the higher frequency range applies Note These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Stellaris PC Vision Enhancement System is used exceeds the applicable RF compliance level above the Stellaris PC Vision Enhancement System should b
144. eps shown on the display screen will vary slightly depending on which optional features are installed on your machine On screen instructions take precedence over information in this manual A WARNING Before beginning a procedure ensure that there is sufficient volume of irrigation solution for the entire procedure Note Ensure tube set connection is secure when connecting to the handpiece and system 1 Set up the sterile field Open the disposable pack and drop contents onto a sterile surface A Note Make sure to use the proper pack for the mode you are using Packs will not work for other modes The packs are color coded Anterior packs are green and or light blue Posterior Packs and Combined Packs are color coded by needle gauge 20 g is black 23 g is green and 25 g is blue Attach the sterile screen drape by placing the drape over the top of the Stellaris PC Vision Enhancement System screen and secure with the adhesive strip to top not the front of the display as shown in the illustration below 1 16 Operator s Manual 110017276EN Rev B 1 Getting Started Figure 1 11 Schematic diagram of sterile draping 1 Adhere screen drape on the top of the screen panel 2 Screen drape 3 Anterior Remote control drape 4 Mayo Tray drape 2 Setup Fluid Collection System e Note Ensure sufficient volume of irrigation solution is available for the procedure The level should be monitored during the procedure
145. er is sent to the system when you flip the main power switch to on i e the stand by power switch is not lit up no faint fan noise from the lower rear of the system etc A blown fuse is usually noticeable after removal from the system by obvious discoloration within the fuse and or an obviously broken fuse wire within the fuse i Note If damage is apparent to either fuse both should be replaced to ensure proper operation a Remove the power cord from the Stellaris PC Vision Enhancement System The presence of the power cord will physically prevent the removal of the fuse drawer b Using a flat blade screwdriver turn the fuse holder counter clockwise and pull outward One style of fuse holder will come partially out and the fuse will drop out On the other style the fuse is retained by clips on the back c Replace the fuses reinstall the fuse holder and lock it by turning clockwise d Snap the fuse drawer back into place e Replace the cord and the system should be ready to run again 6 2 Operator s Manual 110017276EN Rev B 6 Troubleshooting Fuse Holder Location Figure 6 1 Fuse Holder Location 6 3 Informational and Warning Messages All messages displayed by the user interface are uniform in their appearance However the dialog box will have a red border as a warning if a safety related condition is present When an event occurs the system will sound a tone and display a pop up window with the message
146. erating of 25 mmHg per 1000 ft will be used for operation above 3 000 ft The vacuum rise time with an empty cassette shall not increase more than 25 above 1 6 seconds per 1000 feet 305 m of altitude up to 3000 feet 915 m Parameters 110017276EN Rev B Operator s Manual 8 17 8 Specifications eee Viscous Fluid Control Specifications Specification Injection Mode Pressure 70 psi 482 6 kPa 4 8 bar Extraction Mode Vacuum Between 5 to 600 mmHg in 10 mmHg increments Fluid Air Exchange Pressurized Infusion and Air Forced Infusion specifications Parameter Specification Output 0 1 micron hydrophobic filtered air Pressure 150 mmHg maximum air pressure Flow Rate Up to 4 8 standard cubic feet per hour 2 25 L min System includes pneumatic shut off valve in case of power loss Safety Illumination Specifications Parameter Specification Modes of Operation Independent Illumination and control of either port Lamp Type Xenon and Xenon Mercury Light output from a single port is minimum 25 lumens using standard 20g Output grobe Both ports incorporate permanent filtration to reduce ultraviolet violet Safety Filter deep red and infrared light Control 0 100 control range 1 resolution Color Filtration None Green Yellow Amber only available on Port 1 when a xenon lamp is installed 8 18 Operator s Manual 110017276EN Rev B 8 Specifications 8 3 System Labels Baus
147. ersion is not compatible with this RCRO2 Warning 5 representative A compatible software software version Remote Control is not i version must be downloaded available 110017276EN Rev B Operator s Manual 6 9 6 Troubleshooting D Type suggested Action s The remote control receiver has failed to respond to a settings command The SG04 Call your product service RCRO3 Warning Line 5 module settings have been re sent to the representative if this problem persists module The remote control receiver has reset Sat Cali vou brod ct service RCRO4 Warning The module settings have been re sent to eae eee ibessadufe representative if this problem persists SG70 Turn off or dim room lights Certain types of room lighting may cause this type Possible interference with remote control of interference RCRO05 Warning receivers Remote control function may SG71 Check remote functions with A V not be available pop up display SG04 Call your product service representative if this problem persists SG72 Replace the remote control battery at your earliest convenience SG71 Check remote functions with A V pop up display SG04 Call your product service representative if this problem persists The remote control battery level is low RCRO6 Warning Remote control function may not be available shortly User Interface Computer UIC Module Messages iD Type TextMessage Suggested
148. es or Posterior modes with infusion type Auto On ON As the cassette fills up the system gives a Cassette Nearing Full warning When the fluid level reaches the maximum capacity the system gives a Cassette Full warning After this second warning the aspiration function will be disabled You must replace the fluidics cassette with one that is either empty or nearly empty and reprime before aspiration will be re enabled In Posterior Combined domains surgery can be resumed without re priming if the cassette is ejected from the surgical screen 110017276EN Rev B Operator s Manual 4 1 4 Detailed Reference A WARNING Ensure the maximum capacity of the cassette is not exceeded as this could cause a hazardous situation to the patient WARNING Never intentionally modify handpieces or tips such as do not bend cut or engrave as they could break or malfunction Note Stellaris PC Vision Enhancement System is designed with cassette identification feature Use only cassette type that is similar to the selected software domain System error messages will be displayed when wrong cassette type is inserted Emptying Cassette A WARNING Improper reassembly of tubing manifold to the cassette may result in inadequate system performance The Stellaris PC Vision Enhancement System s cassette can be emptied during operation by using following instructions 1 Stop the operation and remove all handpieces from the eye 2 C
149. essures up to 150 mmHg at flow rates up to 3 5 standard cubic feet 99 liters per hour The air pressure from the pump may be adjusted from 0 to 150 mmHg in 1 mmHg increments Fluid Air Exchange Setup and Use The Fluid Air Exchange tubing is an integrated part of the pre connected tubing set of the Stellaris PC Vision Enhancement System procedure pack The function shares the same air source as AFI In the event the air pump is already on for AFI all you need to do to activate Fluid Air Exchange is switch the 2 way stopcock that is attached to the infusion cannula 1 Setup the system for posterior vitrectomy see page 4 7 or combined surgery see page 4 50 2 Select the On Off button to turn On air pump Scrub nurse or Circulating nurse A Note When the pump is turned on the air pressure numeric display will transition to show actual pressure When the pump is off the display indicates the preset air pressure 110017276EN Rev B Operator s Manual 4 19 4 Detailed Reference Figure 4 13 A green ring on the On Off switch indicates air pump has been turned on 3 Select the up down arrows to change the air pressure output Scrub nurse or Circulating nurse 4 Turn the valve of the stopcock to stop the flow of irrigating solution and start the flow of air as shown in Figure 4 14 top Scrub nurse Figure 4 14 The 2 way stopcock control of Fluid Air Exchange Top On Air flows into eye Bottom Off Fluid
150. ethod and Foot Control preview fost Contra Mapsing Linear Figure 2 60 More Settings Screen Aspiration Tab 110017276EN Rev B Operator s Manual 2 55 2 User Interface SS The Infusion Tab shows the current Infusion mode IV Pole Height actual preset and maximum BSS Container Type Patient Eye Level Irrigation Delay and Pressurized Infusion enabled disabled pressure settings and pump on off status 1V Pole Height cm eurem B preset Figure 2 61 More Settings Screen Infusion Tab The actual IV Pole height is the current distance between the aspiration port and the mid point of the BSS drip chamber The maximum IV Pole height is the highest setting the IV Pole will be allowed to reach usually determined by the ceiling height in the room and set at the time of system installation A zero level bottle hanger BL4363 allows the BSS drip chamber to be level with the aspiration port 2 56 Operator s Manual 110017276EN Rev B 2 User Interface zz M Ultrasound More Settings The Ultrasound More Settings Screen shows the current modulation status and power level Depending on which type of ultrasound and programming level you are currently using you may also see number of pulses per second PPS duty cycle DC burst duration BD and pulse interval PI waveform type waveform depth and waveform duration may also be shown All of these settings are adjusted through these screens
151. flows into the eye 1 Air 2 BSS 4 20 Operator s Manual 110017276EN Rev B 4 Detailed Reference Tamponade Air Tamponade Air tamponade is a function where the air pressure is temporarily elevated to a pre programmed level during a Fluid Air Exchange procedure The pressure level for air tamponade is higher than pressure use during normal operation The temporary increase of pressure is normally used to stop intraocular bleeding The Air Tamponade function is enabled by the Elev Inf On Off button on the display see Figure 4 15 or the foot control switch if it is programmed to control Elevated Infusion Adjusting the air pressure above 60 mmHg will also enabled elevated infusion The tamponade pressure is displayed in the surgical screen and may be adjusted by selecting the numeric pressure display or using the touchscreen Up Down arrows Air Tamponade would also be enabled whenever the Fluid Air Exchange pressure level is raised above the programmed tamponade level When the function is enabled a voice confirmation will sound and an elapsed time counter will be displayed in the surgical screen A voice confirmation for tamponade duration will be provided at one minute intervals A bell will be sounded at 30 second intervals When Elev Inf is disabled or the Fluid Air Exchange level is reduced below the tamponade level a voice confirmation will sound and the timer will be cleared from the screen When Elev Inf is toggled off the
152. ft side Group Ungroup Technique switches Right side Group Ungroup Linear Coagulation Disabled Enabled Technique in Setup Mode Reflux Continuous Single High Single Low Technique Phase Next Ultrasound Disabled Enabled Technique Modulation on Yaw Note that for single linear footpedal modes the outward yaw motion Phase would be used for next ultrasound modulation and for dual linear footpedal modes the inward yaw motion would be used Fixed Coagulation 096 to 10 by 1 Technique Power Level 1096 to 3096 by 296 Phase 30 to 100 by 5 Applicable if one of the Foot Control buttons is programmed to activate fixed coagulation Dual Linear Control Mode Level If Enabled at Technique Level U S Modes Disabled Asp on Yaw Asp on Pitch Dual Linear U S I A Modes Disabled Vit Modes Disabled Asp on Pitch Asp on Yaw Dual Irr Mode Coag Modes Disabled not displayed 110017276EN Rev B Operator s Manual 3 29 3 Customizing Your System EH Foot Control Switches The Foot Control switches can be customized at the Technique and Phase levels Anterior Domain unassigned previous phase next phase next U S modulation submode previous U S modulation submode confirm settings irrigation on off reflux air on off vitrectomy cutting on off fixed coagulation increase vacuum decrease vacuum increase air pressure decrease air pressure increase bottle height decrease bottle height increase U S
153. g to patient injury WARNING When using gravity infusion the ophthalmic irrigation source shall be at or above the patient s eye level to avoid patient injury p CAUTION Do not block air vents Note Do not add unapproved accessories that modify the effective IV pole height 110017276EN Rev B Operator s Manual 1 7 1 Getting Started rri Before the first use of the Stellaris PC Vision Enhancement System connect the Foot Control to the system with the Foot Control backup cable provided with the system The following pages contain an overview for setup and use of your Stellaris PC Vision Enhancement System in a typical cataract surgery This information is intended for use by someone who is already familiar with this type of system Turning System On Plug the power supply cord into the wall Connect the compressed air hose to the system If desired connect the Ethernet cable to the port at the bottom of the Stellaris PC Vision Enhancement System and the other end to the hospital network port If you have the optional MMC system this cable should be connected to the MMC and the MMC in turn connected to the hospital network port Refer to page 1 39 for detailed MMC setup instructions Turn on the switch at the bottom of the system console gt WARNING Ensure that the power cord is routed away from traffic areas to prevent accidental disconnection or tripping hazards gt CAUTION Do not turn
154. he eye and clear the aspiration port of lodged material e H ultrasound calibration fails check connections and needle then attempt calibration a second time If calibration fails twice change to a known good handpiece and attempt to calibrate again If a known good handpiece fails calibration or if assistance is needed to determine if the original handpiece is defective contact the Global Product Support see Chapter 7 6 2 Power Issues If you flip the main power switch and no power is sent to the system i e the stand by power switch does not light up there is no faint fan noise from the lower rear of the system etc you may have a bad fuse First check that the rest of the operating suite has power the cord is still plugged in and the wall outlet is still supplying proper power If the power supply chain appears to be intact you may have a blown fuse A blown fuse is usually noticeable after removal from the system by obvious discoloration within the fuse and or an obviously broken fuse wire within the fuse 110017276EN Rev B Operator s Manual 6 1 6 Troubleshooting Fuse Replacement The Stellaris PC Vision Enhancement System has 2 user replaceable fuses If an over current condition should occur which opens these fuses they should be replaced with fuses of the same value as the original fuses see specifications table in Chapter 8 A blown fuse may be indicated when you are using a known good outlet and no pow
155. hould not be sterilized using a cold soaking solution A WARNING All bipolar accessories must be rated for an operating voltage of at least 120V A CAUTION Allow 20 minutes after sterilization for the handpiece and cord to cool before using them again The handpiece connector must be completely dry before it is connected it to equipment 5 2 Operator s Manual 110017276EN Rev B 5 Cleaning and Sterilization Requirements EH A Note No neutral electrode is required for use of the bipolar function The bipolar coagulation forceps eraser and reusable cord should be inspected before each use for signs of misalignment pitting contamination blood tissue etc or other damage Blood saline tissue and other contamination on the tips may be removed by gently scraping with a scalpel blade If the forceps are dropped and seriously misaligned or if deep pits or scores appear on the tips after long use the forceps may be returned to Bausch Lomb for repair refinishing or repotting of the insulating base With the exception of flash methods the items may be wrapped in a surgical towel CSR wrap or equivalent Wipe the forceps using a soft cloth moistened with a mild soap water solution Avoid excessive quantities of solution around the electrical connector Remove all traces of the solution with a cloth dampened with clean water The surfaces should then be dried with a lint free cloth The forceps and reusable cables may be steri
156. ing the system A CAUTION To preserve the surface finish avoid the use of abrasive cleaners If possible clean spots before they dry Bausch Lomb tested the following products and found that they can be used on all external surfaces of the Stellaris PC Vision Enhancement System Use of any substance not listed is at the user s own risk e Isopropyl alcohol 70 Mild soap and water You should wipe the external surfaces of the Stellaris PC Vision Enhancement System Foot Control and remote control with a soft cloth moistened with cleaning solution on a weekly basis while the Stellaris PC Vision Enhancement System is disconnected from any power supply Avoid applying any cleaner directly to the display apply to cloth sparingly Remove all traces of the cleaning solution with a cloth dampened with clean water and dry the surfaces with a lint free cloth 110017276EN Rev B Operator s Manual 5 1 5 Cleaning and Sterilization Requirements E You should clean the fluid level detection lens Figure 5 1 every three months with a 4 x 4 in gauze pad and isopropyl alcohol Figure 5 1 Fluid Level Detection Lens 1 Window Gently swab the electrical connectors with an alcohol swab weekly taking care to avoid excessive quantities of cleaning solution around the ports Do not reconnect to power until the ports have completely dried 5 2 Bipolar Coagulation Accessories A WARNING The coagulation accessories s
157. ion Vacuum Occlusion Ultrasound Coagulation Vitrectomy and Alert The selected tone will be played when that function is active and the frequency of the tone will change with the value of the function Figure 2 69 A V More Settings Screen Audio Tab Select the tone you want to change then use the menu and arrows on the right side of the screen to select the tone used for that condition and the volume at which the tone will be played Only tones not currently in use for another condition will be displayed Voice Confirmation can also be enabled or disabled through this tab 2 64 Operator s Manual 110017276EN Rev B 2 User Interface l The Display Tab control allows you to adjust the screen brightness change the display format level select the system language and view the programming level Figure 2 70 A V More Settings Screen Screen Display Tab 110017276EN Rev B Operator s Manual 2 65 2 User Interface The Video Overlay Tab allows you to select the language to be used for video overlays You can also set whether or not the system will combine Video Overlay Format information such as U S Averages settings and case information By default the U S data is shown as three separate lines on the video overlay If the U S combine option is set to Yes the display will appear on one line which will step through the three values Similarly settings are normally displayed on four lines and case information o
158. ion position two provides fixed aspiration or fixed aspiration with aspiration control feature enabled and position 3 pitch and yaw movements provide linear control of two ultrasound parameters Modes are available for controlling power and pulse rate pulsed power and duty cycle pulsed duration and duty cycle multiple burst power and duration multiple burst and power and duty cycle multiple burst Phacoemulsification Setup A WARNING gt WARNING gt WARNING gt WARNING Note Never intentionally modify handpieces or tips such as do not bend cut or engrave as they could break or malfunction Do not touch an activated ultrasonic handpiece tip as injuries could occur A loose needle may lead to improper tuning and could cause shedding of metal fragments into the eye which can result in serious permanent patient injury For optimum aspiration and reflux performance the patient s eye level must be at the same level as no more than 7 cm 3 in from the Stellaris PC Vision Enhancement System aspiration port Failure to follow this procedure may result in serious and permanent patient injury Specific instructions for cleaning and sterilization included with the handpiece or accessory take precedence over these instructions The ultrasound handpiece needle and irrigation sleeve must be sterilized before performing these steps 1 Turn Power on 2 Press any button on the Foot Control
159. ion is on while no ring indicates the associated function is off Figure 2 5 On Off button Progress Bar This graphic shows the progress of execution of a command 0 100 Ca d Fill Tube Figure 2 6 Sample Progress Bar Numeric Keypad Touching the numeric display on a test tube button brings up the numeric keypad The keypad allows you to rapidly enter numerical surgical settings or change settings Enter a number by touching the proper numeral s then selecting Enter to make the change When a surgical function is active the keypad for settings associated with that function will be disabled If you are entering data into the numeric keypad and activate the Foot Control the numeric keypad will disappear 4 2 3 a 8 99 SIA Kun f 30 5000 A Y Enter Min Max Figure 2 7 Numeric Keypad 110017276EN Rev B Operator s Manual 2 3 2 User Interface Keyboard Sometimes you will need to enter alphabetical or numeric data into the Stellaris PC Vision Enhancement System A keyboard similar to that shown below will appear and you can touch the characters in order to enter them Selecting the back arrow will delete the last character typed and selecting Clear will delete all characters Select Enter when you are done to save the entry and return to the previous screen Figure 2 8 Keyboard Character Lengths When naming functions there is a limit to the number of character
160. iration Cannula DP9740 Softip I A 0 3 Curve Silicone Sleeve 20 Gauge Aspiration Cannula DP9741 Softip I A 0 3 Angled 45 Deg Silicone Sleeve 20 Gauge Aspiration Cannula 6 22 Operator s Manual 110017276EN Rev B 6 Troubleshooting Pack BL5113 StableChamber Phaco Pack with MICS 110017276EN Rev B Operator s Manual 6 23 6 Troubleshooting Posterior Accessories and Packs Category SKU Description o 6 24 Operator s Manual 110017276EN Rev B 6 Troubleshooting Een Category sku Description o Pack BL5325W TSV 25 Ga Combined Vitrectomy Pack with Wide Field Illuminator Pack BL5420W 20 Ga Posterior Vitrectomy Pack with AFI and Wide Field Illuminator Pack BL5423W TSV 23 Ga Posterior Vitrectomy Pack with AFI and Wide Field Illuminator Pack BL5425W TSV 25 Ga Posterior Vitrectomy Pack with AFI and Wide Field Illuminator Pack BL5520W 20 Ga Combined Vitrectomy Pack with AFI and Wide Field Illuminator Pack BL5523W TSV 23 Ga Combined Vitrectomy Pack with AFI and Wide Field Illuminator Pack BL5525W TSV 25 Ga Combined Vitrectomy Pack with AFI and Wide Field Illuminator 110017276EN Rev B Operator s Manual 6 25 6 Troubleshooting 6 26 Operator s Manual 110017276EN Rev B 7 Service and Warranty LL SSS SS Service and Warranty This chapter contains instruction on how to contact Bausch Lomb to obtain service on your Stellaris PC Vision Enhancement System as well as warranty
161. is another Foot Control using the wired cable replaced immediately connection to the system SG33 Use the wired cable connection to the system WFCIS8 Info System not detecting the Foot Control SG34 Replace the Foot Control with another Foot Control using the wired cable connection to the system SG100 Connect the Foot Control cable to The system has lost communications continue case a with the Foot Control wireless disabled SG101 See Operators Manual for re enabling wireless communication 6 16 Operator s Manual 110017276EN Rev B u The system has lost communications with the Foot Control Foot Control Receiver Module Messages D Type TextMessage suggested action s WFROI WFRO2 WFRO3 WFRO4 The Foot Control receiver was not detected in the system Surgical mode is not available The Foot Control receiver software version is not compatible with this software version Surgical mode is not available The Foot Control receiver has failed to respond to a settings command The module settings have been re sent to the module The Foot Control receiver has reset The module settings have been re sent to the module Internal Application Messages 6 Troubleshooting iD Type TextMessage suggested action s SG99 Check the cable connection SG34 Replace the Foot Control with another Foot Control using the wired cable connection to the system SG04 Call your product servi
162. ission 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 1 40 Operator s Manual 110017276EN Rev B 1 Getting Started ee eee Figure 1 25 Placement of Foot Control During Storage The Foot Control contains an internal rechargeable battery The battery cover has the battery symbol on it The battery must be charged overnight prior to initial wireless use or if the system is idle for more than seven days Refer to the battery charging options section on page 1 51 Foot Control Battery Installation Guide A Note Replacing the battery when the system is powered up will disable the foot control wireless set up To re enable wireless set up see page 1 46 1 Place the Foot Control upside down on a flat dry surface 2 Open the battery door by pressing the targets on the door toward the battery compartment and turn the two latches 90 degrees away from the center 3 Remove the battery with two fingers holding on to the battery 110017276EN Rev B Operator s Manual 1 41 1 Getting Started e 4 Before installing the replacement battery check the battery electrical contacts to ensure they are clean and free of contamination 5 Install the new battery 6 Press the door toward the compartment and engage door latches to securely close the battery
163. ith Prime and Tune as the highlighted function 6 Spike the BSS bottle and hang it at the desired bottle height Additional step if pressurized infusion is used Connect the Air Tubing Line to the vent port at the bottle spike and the other end with air filter to the Stellaris PC air output connector Switch on the air pump from the system setup screen use the control in the upper right hand corner of the screen The output connector will remain lit when it is at commanded pressure and blink on and off when it is not at the commanded pressure 7 Connect tubing to the UA handpieces Select Show Me Steps for animated setup guide if necessary 8 Ensure the irrigation clamp is open and toggle Irrigation Off to turn the flow on and allow irrigation to fill the tubing up to the handpieces 9 Fillthe test chamber with irrigating solution then slide over the tip of the handpiece 10 Select Prime Only A vacuum test is part of the priming cycle 11 After successful priming and tuning the Main Surgical Screen will be displayed The external components of your system are now ready Continue to set the operating parameters A Note Hold the handpiece tip towards the ceiling while priming the irrigation line to insure all air has been removed I A Use 1 Select the I A mode on the clock menu 2 Use the spin control buttons to set the desired aspiration vacuum 3 The system is now ready for Irrigation Aspiration A Note
164. itiate the auto priming and tune ultrasound sequence Hold the handpiece until prime tune completes and the system transition to the Surgical Screen Scrub or Circulating nurse 8 Select Frag mode from the clock menu to perform the fragmentation procedure Scrub or Circulating nurse Figure 4 21 Hold frag handpiece with tip submerged into water during priming and tuning 4 3 Anterior Functions Irrigation Irrigation is part of the fluidics system providing continuous fluid flow to compensate for fluid aspirated out of the eye Irrigation on off is controlled by the pinch valve which is opened when the footpedal is pressed and closed when the footpedal is released An Irrigation only mode is available in which the footpedal controls irrigation on off The Fill Button on the Surgical Screen opens the irrigation control valve for 20 seconds to facilitate collection of irrigation solution into a surgical container 110017276EN Rev B Operator s Manual 4 29 4 Detailed Reference Irrigation Aspiration Function 1 A e Note Do not pull the tubing taut it must be allowed to have a droop or sag between the cassette and the handpiece Note Whenever the cassette is ejected from the system console keep the handpiece above the level of the cassette port The Advanced Vacuum Function provides vacuum levels from 0 mmHg to 600 mmHg in 1 mmHg increments depending upon the mode of operation Aspiration limits are set via th
165. l switches assigned to this function Pressing the foot pedal into region 1 will NOT start infusion A Note When the system is in Manual Infusion Mode pressing the Foot Pedal will not activate aspiration e In Auto On Off Infusion Mode infusion will be activated when the foot pedal is depressed into region 1 or beyond and will be deactivated when the foot pedal is released to region 0 for all aspirating modes The GUI screen and a foot control switch assigned to this function will toggle between infusion always on and infusion On Off with the foot pedal This infusion option is identical to the infusion control in all anterior modes e In Auto On Infusion Mode infusion control is the same as in Manual Infusion Mode except that infusion will be activated as soon as the foot pedal is depressed into region or beyond and will remain active when the foot control pedal is released to region 0 4 10 Operator s Manual 110017276EN Rev B 4 Detailed Reference For all infusion control modes Infusion once started cannot be turned off using either the GUI or the foot control switch while the foot control pedal is in region 1 or beyond A Note In all circumstances the stopcock and tubing clamp may be used to stop infusion Note The system will prime the left aspiration line right aspiration line cutter test and infusion line and the cannula Irrigation will be shut off and some BSS will be left in the priming cup at the end
166. l the brush back out Thoroughly clean the brush after each use and sterilize at the end of each day according to CX7120 Universal Maintenance Kit instructions 110017276EN Rev B Operator s Manual 5 11 5 Cleaning and Sterilization Requirements SSE K oos gn m 5 12 Rinse both ends of the handpiece aspiration lumen Holding the handpiece downward at a 45 angle and rinse the aspiration fitting with warm 30 C to 40 C distilled or deionized water Repeat this process for the front of the handpiece Wipe each end of the handpiece with clean gauze to remove any deposited protein material Refill the syringe with 50 cc ml of warm distilled or deionized water Connect the end of the syringe to the center stopcock fitting Rotate the stopcock lever to allow fluid flow to the female luer fitting Connect the stopcock female luer fitting to the handpiece aspiration fitting Push on the syringe plunger to force fluid through the handpiece into another beaker for proper disposal Do not draw flushing fluid back through the handpiece Disconnect the syringe Repeat Steps M through Q at least four times Fill the syringe with air reattach to stopcock and push on the syringe plunger to force air through the handpiece Disconnect the syringe Repeat Step S at least three times Sterilize the handpiece as follows High Vacuum Pre vacuum Sterilization Wrapped for a minimum of 3 minutes at 134 C 206 8 kPa 2 068 bar 27
167. laris PC Vision Enhancement System Upon shutdown from the End of Surgery screen the system will offer a prompt to Send data to TruLink If you agree make sure that the Ethernet cable is connected to the designated port and follow instructions After updating the system will shut down automatically Multimedia Center MMC optional The MMC if available provides streaming video on the surgical screen and microscope overlay capability The MMC supports NTSC and PAL format composite video and S video or a FireWire digital camera Figure 1 24 Multimedia Center MMC optional 1 Main Power Switch 2 Connection Indicator LED from Stellaris PC Vision Enhancement System 3 Connection Indicator from microscope camera 4 Connection Indicator LED to TruLink Customer Support Network Data is transferred between the MMC and the Stellaris PC Vision Enhancement System through an Ethernet cable that runs from the back of the MMC system to the Ethernet port on the bottom of the system Whenever the MMC is on and connected and the Stellaris PC Vision Enhancement System is in surgical mode the 110017276EN Rev B Operator s Manual 1 39 1 Getting Started current video image will appear on screen in the center of the Clock Menu You can touch the video image itself to toggle between small and large display sizes You can also touch the outer edge of the video display to toggle between the video display itself and an animation showing
168. le pressing the Next button will cycle through all possible suggested actions Pressing the Close button will remove this window 2 6 Operator s Manual 110017276EN Rev B 2 User Interface 2 2 Posterior and Combined Domain Surgical Information More Settings Screens More Settings Screens allow easy access to all system parameters In the posterior and combined domains pressing the More Settings Screen button will cause a tabbed window the More Settings Screen to appear through which system settings and parameters can be changed The specific More Settings Screen options available at any given time will depend on the current surgical domain and phase as detailed in the table below If a setting has been changed in a More Screen the text will be blue instead of black to highlight the modification Once the change is saved the text will turn black Posterior and Tabs Displayed on More Settings Screen Combined Domain Modes Setup with Linear Coag Infusion Illuminators Foot Control A V Messages Figure 2 12 Coagulation Setup without Linear Infusion Illuminators Foot Control A V Messages Figure 2 13 Coagulation Cut Vacuum Infusion Illuminators Foot Control A V Messages Figure 2 14 Cut Vacuum Infusion Illuminators Foot Control A V Messages Figure 2 15 U S Vacuum Infusion Illuminators Foot Control A V Messages Figure 2 16 U S Vacuum Infusion Illuminators Foot Control A V Messages
169. led as a function of footpedal travel in Region 3 The next ultrasound submode may be selected if enabled by moving the footpedal in the outward yaw direction Single Linear Ultrasound Mode with Linear Aspiration Once irrigation has been initiated and the footpedal has been depressed approximately five degrees or as programmed an increase in footpedal resistance will be noted signifying the transition from Region to Region 2 and the start of aspiration Aspiration will increase from 0 to the fixed level in proportion to footpedal travel in Region 2 The screen will display the actual amount of aspiration Aspiration will remain at the fixed level in Region 3 Ultrasound power is activated in Region 3 of footpedal travel Another momentary increase in footpedal resistance will be noted signifying the transition from one region to the next and the start of ultrasound power Linear ultrasound power will be initiated and controlled as a linear function of footpedal travel in Region 3 Pulsed ultrasound may be toggled on off by moving the footpedal in the outward yaw direction A Note If single or multiple burst mode is selected position 3 or outward yaw movement does not control ultrasound power but rather the burst interval for multiple burst or nearly full travel initiates and resets the single burst see page 4 36 110017276EN Rev B Operator s Manual 4 35 4 Detailed Reference Dual Linear Ultrasound Mode with Aspiration in
170. level Waveform Ultrasound modulation where power delivery is software controlled to simulate a sinusoidal wave pattern 110017276EN Rev B Operator s Manual 9 5 9 Glossary Xenon lamp A type of lamp used in the Stellaris PC Vision Enhancement System to provide endoillumination It contains pure xenon gas and emits whiter light with a full spectrum Xenon Mercury lamp A type of lamp used in Stellaris PC Vision Enhancement System to provide endoillumination It contains xenon gas and small amounts of mercury metal and emits greener light Yaw Side to side movement of foot pedal 9 6 Operator s Manual 110017276EN Rev B Index A Actual Phaco Time APT 4 33 APT Actual Phaco Time 4 33 Aspiration Handpiece Cleaning 5 4 Sterilization 5 5 Aspiration Setup Vacuum Fluidics 4 31 Aspiration Ultrasound 4 37 Assistance 7 1 Audio Tab 2 28 2 63 AVE Average Ultrasound Power 4 33 Average Ultrasound Power AVE 4 33 A V More Screen 2 28 2 63 B Backup 3 15 Batteries Remote Control 1 35 Burst U S 4 33 4 36 Button Spin 2 40 C Calibration U S 4 37 Capsule Polish Operation 4 30 Cassette Full 4 1 Cassette Nearing Full 4 1 Cleaning Handpiece Bipolar Accessories 5 2 For U K 5 11 Irrigation Aspiration 5 3 Needle Ultrasound 5 10 Clock Menu 2 34 2 68 Coag Display 2 39 2 73 Coag Spin Control 2 73 Coagulation Accessories Cleaning 5 2 Setup Fixed 4 47 Linear 4 48 Function Specifications 8 1
171. lized as follows Standard Gravity Steam Sterilization Wrapped for 30 minutes at 121 C 104 8 kPa 1 048 bar 250 F 15 2 psi Flash Sterilization Unwrapped but covered for 10 minutes at 132 C 186 8 kPa 1 868 bar 270 F 27 1 psi High Vacuum Pre vacuum Sterilization Wrapped for 3 minutes at 134 C 206 8 kPa 2 068 bar 274 F 30 0 psi Refer to ANSI AAMI ST79 2006 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities and or your institution s policies regarding restrictions on the use of flash sterilization 5 3 Irrigation and Irrigation Aspiration Handpieces A CAUTION Use only warm 30 C to 40 C or 85 F to 105 F distilled or deionized water to flush the handpiece The handpiece must be cleaned and autoclaved before it is placed into service the first time before initial use each day and between each use in accordance with the following instructions 110017276EN Rev B Operator s Manual 5 3 5 Cleaning and Sterilization Requirements Handpiece Cleaning Instructions Figure 5 2 Irrigation and Aspiration Handpiece Flushing Setups 1 I A Handpiece 2 Aspiration Fitting 3 3 Way Stopcock 4 Syringe 5 Irrigation Fitting 6 Female Luer Disconnect the tubing and remove the irrigation sleeve B Place the end of the syringe into a beaker of warm 30 C to 40 C or 85 F to 105 F distilled or deionized water and fill the syringe to the 50
172. lose both irrigation clamps the clamp near the bottle and the clamp at the 2 way stopcock 3 Select Eject Cassette from the surgical screen 4 Remove the cassette from the system 4 2 Operator s Manual 110017276EN Rev B 4 Detailed Reference 5 Detach the aspiration tubing that connects to the cassette Hold aspiration tubing very close to the connector to facilitate removal pink arrows 6 Press manifold release latch to free it from the cassette Pink arrows 7 Drain the fluid out of the cassette 110017276EN Rev B Operator s Manual 4 3 4 Detailed Reference 8 Assemble tubing manifold by first sliding the front end under the cassette retainer R 9 Press the manifold to latch manifold to the cassette 10 Connect aspiration tubing to the cassette connector 11 Insert cassette to the system 12 Release irrigation clamp The clamp near the bottle and the clamp at the 2 way stopcock 13 Resume surgery once system pass vacuum check and surgical screen is displayed A Note No re priming is needed 4 4 Operator s Manual 110017276EN Rev B 4 Detailed Reference 4 2 Posterior Functions Posterior Vitrectomy Function The Stellaris PC Vision Enhancement System vitrectomy function uses an external air source to drive the pneumatically operated guillotine type vitrectomy cutter that draws the vitreous material into the port The vitreous is then cut and aspirated into a disposable
173. low Viscous fluid injection pressure is high Viscous fluid extraction vacuum is low Viscous fluid extraction vacuum is high The internal air pressure supply to the vacuum fluidics module is low The irrigation and aspiration pinch valves may not be functioning properly The vitrectomy cutter input pressure is high The vitrectomy cutter is not available The internal air pressure supply to the vacuum fluidics module is high The irrigation and aspiration pinch valves may not be functioning properly 6 Troubleshooting iD Type TextMessage suggested action s SG46 Check the air or fluid infusion pressure to be suitable for use in surgery SG04 Call your product service representative if this problem persists SG25 Confirm correct infusion and aspiration function SG31 Confirm correct vitrectomy function SG04 Call your product service representative if this problem persists SG31 Confirm correct vitrectomy function SG04 Call your product service representative if this problem persists SG91 Confirm correct viscous fluid injection function SG04 Call your product service representative if this problem persists SG91 Confirm correct viscous fluid injection function SG04 Call your product service representative if this problem persists SG92 Confirm correct viscous fluid extraction function SG04 Call your product service representative if this problem persists SG92 Confirm correct visc
174. lux feature is activated by inward movement of the footpedal in all aspiration modes Continuous Reflux Reflux pressure is based on irrigation pressure 4 30 Operator s Manual 110017276EN Rev B 4 Detailed Reference Pulse Reflux Reflux is created by the momentary activation of a plunger on the reflux bulb Pulse reflux is only available with combined cassette only Vacuum Response Vacuum response refers to the amount of time required to obtain the desired aspiration level A fast response value instructs the system to achieve the desired aspiration level in the shortest amount of time similarly slow indicates that the time to achieve the desired aspiration will be significantly longer The response can be changed through the programming interface see Chapter 3 or the Fluidics More Screen see page 2 55 The Advanced Vacuum System has five levels of vacuum response setting with one being fastest response and five being slowest response Foot Control of Irrigation Aspiration As the footpedal is initially pressed the irrigation control valve will open to allow irrigation into the eye Once irrigation has been initiated and the footpedal has been depressed approximately five degrees or as programmed a momentary increase in footpedal resistance will be noted signifying the transition from Region 1 to Region 2 and the start of aspiration Aspiration increases proportional to footpedal travel with the maximum level being set vi
175. ly which will activate a shorter cycle of aspiration and tuning without the vacuum test Select the Prime Only button from the Prime and Tune Screen to initiate priming of the irrigation and left aspiration line followed by a vacuum test The irrigation line and the aspiration line need to be connected to the ultrasound handpiece with the test chamber attached to the tip of the ultrasound handpiece During this process the IV bottle will be raised to 100 cm or the system will use a pressure of 73 mmHg if AFI is used After the line has been primed the button will activate a shorter cycle of aspiration without the vacuum test Select the Pneumatic Vit test to activate aspiration and a test of the pneumatic cutter In the anterior domain the remote control can be used to activate functions in the Prime and Tune window of the setup screen The remote control UP DOWN buttons are used to move the arrow and select options in the Prime and Tune window 1 20 Operator s Manual 110017276EN Rev B 1 Getting Started je V pm n Prime and Tune Pressing the Enter button of the remote control activates the selected function as indicated by the arrow Once Prime and Tune is initiated by any of these options a Cancel button will appear Selecting the Cancel button will immediately stop the priming and tuning process When Prime and Tune is in progress a progress bar at the lower left hand corner is displayed to indicate
176. mum setting The Actual U S progress bar displays amount of ultrasound power being used in relation to the maximum setting The Elapsed Time display indicates the time in minutes and seconds that ultrasound power has been energized A Note See Chapter 5 for cleaning and sterilization requirements when surgery is completed 110017276EN Rev B Operator s Manual 4 39 4 Detailed Reference Anterior Vitrectomy Function The Stellaris PC Vision Enhancement System supports a pneumatic vitrectomy cutter which uses pressurized air to drive the guillotine type vitrectomy cutter The Advanced Vacuum system provides aspiration to draw the vitreous material into the port where it is then cut and aspirated through the flexible tubing into the disposable collection container Anterior Vitrectomy Cutter Modes The Advanced Vacuum System provides two vitrectomy cutter modes Fixed Cut Pneumatic cutter The control may be adjusted to provide a fixed cutting speed from 30 to 5000 cuts per minute Dual Linear Cut Pneumatic cutter The control may be adjusted to provide a linear cutting speed from 30 to 5000 cuts per minute The footpedal yaw is used to achieve dual linear function The cut rate may be adjusted from 30 to 5000 cpm with increments as shown in the table below or to any specific value using the keypad Range step Size 30 to 100 cpm 100 to 1000 cpm 1000 to 5000 cpm 100 cpm Planned Anterior Vitrectomy Setup A W
177. n The surgeon may be able to continue with the procedure once the error has been rectified Figure 2 51 Sample Message Window For each message displayed suggested actions to resolve the condition are displayed If more than one suggested action is available pressing the Next button will cycle through all possible suggested actions Selecting Close will close this window 2 46 Operator s Manual 110017276EN Rev B 2 User Interface 2 6 Anterior Domain Surgical More Settings Screens More Settings Screens allow easy access to all system parameters In the anterior domain pressing the More Settings Screen button will cause a tabbed window More Settings Screen to appear through which system settings and parameters can be changed EX 2 Figure 2 52 More Settings Screen Button Anterior Domain Mode Tabs on More Settings Screen DIE Setup with Linear Coagulation Coag Infusion Foot Control A V Messages Figure 2 53 Setup without Linear Coagulation Infusion Foot Control A V Messages Figure 2 54 g 54 Anterior Vitrectomy Cut Vacuum Infusion Foot Control A V Figure 2 55 Messages U S Vacuum Infusion Foot Control A V Figure 2 56 g 58 Vacuum Infusion Foot Control A V Messages Figure 2 57 Infusion Foot Control A V Messages Figure 2 58 Linear Coagulation Coag Infusion Foot Control A V Messages Figure 2 59 Each More Settings Screen has a dropdown submode selection window x as well as S
178. n Region 3 of footpedal travel Another momentary increase in footpedal resistance will be noted signifying the transition from one region to the next and the start of ultrasound power Linear ultrasound power will be initiated and controlled as a linear function of footpedal travel in Region 3 e Note If single or multiple burst mode is selected position 3 or outward yaw movement does not control ultrasound power but rather the burst interval for multiple burst or nearly full travel initiates and resets the single burst Dual Linear Ultrasound Mode with Aspiration in Pitch Irrigation is activated by Region 1 of footpedal travel As the footpedal travels through Region 1 the irrigation pinch valve will open to apply irrigation to the eye Aspiration is activated by Region 2 of footpedal travel A momentary increase in footpedal resistance will be noted signifying the transition from Region 1 to Region 2 and the start of aspiration In Region 2 linear aspiration will be developed at the selected aspiration level The screen will display the actual amount of aspiration Linear ultrasound power will be initiated and controlled as a linear function of outward yaw footpedal travel in position 2 4 36 Operator s Manual 110017276EN Rev B 4 Detailed Reference EE Dual Linear Ultrasound Dual Linear Ultrasound mode allows control of two ultrasound parameters one on pitch and one on yaw In these modes position one provides irrigat
179. n camera is plugged directly into monitor Is video input selection correct on VCR and Monitor Is camera plugged into VIDEO IN or S VIDEO IN Is MMC powered up power indicator on Are power cord s connected correctly Check video connections IN OUT S Video Video Is the Stellaris PC Vision Enhancement System in a surgical mode displayed Is the data cable connected correctly not visible Is monitor set to correct format NTSC or PAL flickering video Is monitor set to correct format NTSC or PAL Is camera powered on Rolling video Video format may not be supported Is monitor set to correct format NTSC or PAL No camera video No overlay logo displayed Ethernet cable connected Camera turned on Check video connections Cycle power on MMC Cycle power on system and power up MMC No streaming video on console When the problem occurs the system will automatically turn on the irrigation valve to provide continuous irrigation System main functions such as aspiration and ultrasound will cease to operate System modules To resume system operation perform the following reset momentarily A Go to Setup Screen B Replace test chamber on the ultrasound handpiece C Select Prime and Tune D Following successful prime and tune the system will go to surgical mode to resume operation 6 20 Operator s Manual 110017276EN Rev B 6 Troubleshooting Symptom Action Required When the problem occurs the system
180. n two lines but if the combine option is set to Yes each will appear on one line that will step through the values Finally you can set the video overlay overscan in one degree increments from 0 to 5 av Ceo _ Gm E Figure 2 71 A V More Settings Screen Video Overlay Tab 2 66 Operator s Manual 110017276EN Rev B 2 User Interface SEES Se Case More Settings Screen The Case More Settings Screen shows the case number total number of rooms in which the Stellaris PC Vision Enhancement System will be used the room number in which the system currently resides as well as the technique needle grade and pathology for the current case Select the parameter to be changed and then select the new setting from the option list When you have made all the desired changes select Close and the change will take effect You can select Save Settings to have the new settings overwrite the current surgeon s preferences and be stored in the main preferences file Figure 2 72 Case More Settings Screen A Note Selecting Save Settings here will save all changes made through any aspect of the user interface You can select Reset Averages to clear the average values and elapsed times for the surgical functions for this case 110017276EN Rev B Operator s Manual 2 67 2 User Interface 2 7 Anterior Domain Surgical Screen Layout A Note Voice confirmation if enabled responds to Foot Control and remote
181. nal choices are available and selecting the currently displayed option will bring up a list Only one option can be selected at a given time Selecting one option automatically deselects others 110017276EN Rev B Operator s Manual 2 41 2 User Interface Allow Remap Pedal Allow No Limiting Not While Active Figure 2 45 Sample Drop Down Option List 2 42 Operator s Manual 110017276EN Rev B 2 User Interface Test Tube Display and Control This type of control allows you to set the limits of a system parameter The actual value is displayed above the tube and the allowable minimum and maximum values are shown beside the tube The current setting may be changed by selecting and dragging the slider ring The slider ring may not be positioned below the current setting minimum value The minimum value may be changed with the surgical function More Settings Screen Figure 2 46 Sample Test Tube Display Progress Bar This graphic shows the progress of execution of a command 0 100 Figure 2 47 Sample Progress Bar 110017276EN Rev B Operator s Manual 2 43 2 User Interface Numeric Keypad Selecting a number on a spin control button brings up the numeric keypad The keypad allows you to rapidly enter numerical surgical settings or change settings Numbers are entered by touching the numeral then select Enter to make the change When a surgical function is active the keypad for settings associated
182. nd fixed cut Cutter On cut vitrectomy when Off Disabled Single Single Cu eu R2 UincarAspiraion Sinai Cu Vitrectomy Dios t er Aii ner Co Aspiration on Yaw s Aspiration i Linear Aspiration Cutter On 1 60 Operator s Manual 110017276EN Rev B 1 Getting Started 1 13 Illumination Function General introduction to setting the correct light level The guidelines provided in this section are based on ISO15752 2000 E ISO15004 2 2007 E and ISO DIS 15752 The Stellaris PC Vision Enhancement System illumination system comes with a state of the art visualization module to enhance the surgeon s ability to see effectively during procedures The output from the illumination probe can attain high lumen levels if needed is filtered to minimize hazardous light and is very flexible providing easy to access color filter options to enhance safety and tissue visibility As with any high intensity illumination system used in the eye care is needed during use to reduce potential for damage to intraocular tissues A WARNING The light emitted from this instrument is potentially hazardous Avoid concentrating the illumination output on a small area of the retina for prolonged periods of time due to the potential for photoretinitis and serious permanent patient injury Set the illumination level to the minimum needed to perform the surgical procedure There are two mechanisms by which harm can be induced e Photoretinitis
183. nd linear ultrasound in food pedal region 2 The outward yaw in any footpedal region controls ultrasound On Off Dual Yaw US Frag This submode provides linear vacuum control on footpedal pitch and linear ultrasound on outward yaw in footpedal region 1 Fragmentation Setup and Use e Note Prior to setting up Fragmentation the Stellaris PC Vision Enhancement System has to be setup for Posterior Vitrectomy or Combined surgery Note Specific instructions for cleaning and sterilization included with a handpiece or accessory take precedence over these instructions WARNING A loose needle may lead to improper tuning and could cause shedding of metal fragments into the eye which can result in serious permanent patient injury 1 Setup the system for posterior vitrectomy page 4 7 or combined surgery page 4 50 2 Ensure the screen is displaying the Prime Tune Setup screen 3 Connect the handpiece electrical connector to the connector on the machine Scrub nurse or Circulating nurse 4 Thread and firmly secure the single use fragmentation needle onto the fragmentation handpiece using a needle wrench Scrub nurse Note Pack number BL5275 would be appropriate for use 5 Connect the clear aspiration line to the fragmentation handpiece Scrub nurse 4 28 Operator s Manual 110017276EN Rev B 4 Detailed Reference 6 Hold the handpiece with tip submerged into BSS solution Scrub nurse 7 Select Prime Test U S to in
184. nsition to wireless operation every time the backup cable is disconnected The cassette was not fully inserted This can occur if the cassette is inserted slowly and captured in a position that affects the performance of the fluid level sensor This may also occur if the cassette is inserted too fast and released before the capture mechanism captures the cassette at the optimum position Check Offset switch at the back of the foot pedal ensure switch is fully engaged to the Left Right or Center Following the disconnection of backup cable initiate wireless Foot Control connectivity by pressing one of the Foot Control buttons The right LED light would light up within 10 seconds indicating wireless connection is ready Eject cassette and reinsert To ensure cassette is properly positioned in the system firmly insert the cassette until it snaps in place 110017276EN Rev B 6 DEREN Symptom Potential Cause Corrective Action No or low infusion with System displays actual pressure correctly and 1 Air tubing or irrigation Pressurized Infusion air is coming out of the air output connector tubing may be kinked function Check air tubing and If problem persists with the all of the above irrigation tubing for kink corrective actions stop using Pressurized or pinch Infusion and call service 2 The air tubing pathway may be obstructed Ensure new air tubing is used Otherwise replace with new tubing 3
185. ntation and the third port is for coagulation see page 1 35 The remainder are reserved for future use The single port at the top of the cassette housing provides air pressure to drive the pneumatic vitrectomy cutter 1 34 Operator s Manual 110017276EN Rev B 1 Getting Started Hr See There are 4 ports down the right side of the system for connecting specific system accessories The first port 6 in figure below is for Viscous Fluid Injection amp Aspiration The second port 7 in figure below is for air forced infusion and Fluid Air Exchange The third port 8 in figure below is for lamp 2 and provides illumination See page 1 61 The fourth port 9 in figure below is for lamp 1 and provides illumination with selectable filters See page 1 61 nN amp t ym Figure 1 22 Front panel with handpiece connectors 1 Reserved for future use 2 Ultrasound 3 Coag 4 Reserved for future use 5 Reserved for future use 6 VFC 7 F AX and AFI 8 Lamp 2 9 Lamp 1 Ultrasound Functions Phacoemulsification and Fragmentation A WARNING Manufacturers of implantable defibrillators recommend that these devices be temporarily disabled when using phacoemulsification or systems on patients with these implants This is especially important when using pulsed phaco modes of operation Although the implanted devices are designed to reject electromagnetic interference and Bausch Lomb Vision Enhancement equipment is designed
186. nterior segment surgeries with the dedicated software interface and packs Select Posterior Anterior Domain in the Select Procedure start up screen to begin The Posterior Anterior Domain user interface allows the user to perform all the posterior and anterior functions from a single surgical screen and cassette pack A Note Make sure the pack you are using is appropriate for the domain selected Combined Procedure Setup and Use a Note Specific instructions for cleaning and sterilization included with any handpiece or accessory take precedence over these instructions WARNING For optimum aspiration and reflux performance the patient s eye level must be at the same level as no more than 7 cm 3 in from the Stellaris PC Vision Enhancement System aspiration port Failure to follow this procedure may result in serious and permanent patient injury 1 Connect the compressed air source to the connector on the lower rear of the system Turn the power on and wait until the screen displays the Foot Control or other system messages Acknowledge and close all messages eee cB To operate the Foot Control wirelessly press any button on the Foot Control and wait until the right light turns solid green This indicates that wireless communication has been established 5 The screen will display Select Procedure If your system is programmed to default to either the Anterior Domain or the Posterior Combined Domain the Select Procedu
187. nty period which commences on the date of delivery Bausch Lomb reserves the right to deny warranty coverage and shall have no responsibility to repair or replace any non conforming or defective equipment or component under this warranty if a the Stellaris PC Vision Enhancement System is not maintained and operated in accordance with all manufacturer s instructions b the non conformity or defect arises from or is related to any service or maintenance of the equipment or component s thereof provided by persons other than Bausch Lomb or its authorized service representatives c the non conformity or defect arises from or is related to any spare or replacement part s or component s or any consumable or disposable products or parts which are used in the operation of the equipment or its components other than those purchased from installed by or approved for use by Bausch Lomb or its authorized service representatives d the Stellaris PC Vision Enhancement System has been altered neglected abused or misused e the Stellaris PC Vision Enhancement System has been relocated reinstalled or taken apart by any person other than Bausch Lomb or its authorized service representative f the non conformity or defect arises from or results from any damage to the Stellaris PC Vision Enhancement System or its components occurring subsequent to delivery or g the non conformity or defect is not reported 7 10 Operator s Manual
188. ocking charge of 15 of the purchase price listed on the invoice for the product in addition to any refurbishment handling and shipping charges may be assessed for any return received after the return period but not greater than 180 days of the invoice date Handpiece Disclaimer Bausch Lomb is the only authorized service organization for Bausch Lomb handpiece Bausch Lomb does not recommend having your handpiece repaired by third party service organizations and assumes no responsibility or liability for the function safety of operation of any handpiece repaired or serviced by anyone other than the Bausch Lomb service organization 7 12 Operator s Manual 110017276EN Rev B 8 Specifications ee Specifications 8 1 Environmental and Physical Specifications A Note This device contains items which may be classified as waste electrical or electronic equipment Please dispose of the equipment according to local requirements This symbol indicates that the product must be disposed of separately and safely Therefore it is your responsibility to dispose of this waste equipment by handing it over to a designated collection point or organization that specializes in the recycling of waste electrical and electronic equipment The separate collection and recycling of your waste equipment at the time of disposal will help conserve natural resources and ensure that it is recycled in a manner that protects human health and the environment Fo
189. ode phase Examples of Vitrectomy sub modes are Fixed Cut Co Linear Vit and Single Cut 9 4 Operator s Manual 110017276EN Rev B 9 Glossary EH Surgeon Level It is the second highest programming level after the System level setting in the Stellaris PC Vision Enhancement System system hierarchy Typical Surgeon level settings are language foot control settings audio visual feedback and units of measurement Technique Level Refers to surgical settings within the Surgeon level programmed either for anterior posterior or combined surgery It is a subset of the Surgeon level setting Stellaris PC Vision Enhancement System includes a list of default techniques settings and individual users can create new techniques using the default techniques as a template Tone System audio feedback specific to surgical functions and energy level TruLink Bausch amp Lomb technology that provides the capability to interact with Stellaris PC Vision Enhancement System installations remotely for diagnostic purposes Vacuum Response Speed with which system generates commanded vacuum level Stellaris PC Vision Enhancement System has a vacuum response range of 1 to 5 1 fastest Video Overlay Feature that simultaneously projects system settings on the surgical video screen Viscous fluid Refers to high viscosity fluids Normally refers to silicone oil use in posterior segment surgery Volume System audio feedback output
190. omain Posterior Domain or the Combined Domain the Select Procedure Screen will not appear and the system will move directly to the Select Surgeon Screen as shown in Figure 1 7 below 110017276EN Rev B Operator s Manual 1 11 1 Getting Started Figure 1 7 Select Surgeon Screen Select Surgeon Selecting Go To Surgery option will advance the system to the Setup Screen using the system s default parameters Touch the name of a surgeon on the list to highlight it Then select Confirm to load the parameters for that surgeon and advance to the Setup Screen A Note Ifthe Confirm button is not active this indicates one or more modules were not detected in the system and further operation is not allowed To set up default parameters for a new surgeon instead of using an existing surgeon s file select Create New This will allow you to setup a file for a new surgeon using parameters from an existing surgeon as a template 1 12 Operator s Manual 110017276EN Rev B 1 Getting Started Setup Screen The Setup Screen allows you to set certain procedure parameters and prepare the system for surgical procedures The Open Pack Insert Cassette option will be highlighted when you initially see this screen If desired select Select Room Anterior Only and choose the case number number of operating rooms being used by the surgeon and the particular operating room to be used If desired select Select Case Anterior or Ca
191. ons are described below For Posterior Domain Select the Easy Prime button from the Prime and Tune screen to fill the left and right tubing with BSS solution and then perform a test of the pneumatic cutter During this process the gravity feed infusion I V pole will raise to 100 cm or lower if maximum ceiling height is set lower than 100 cm for the anterior In the posterior combined domains I V pole will raise to the maximum ceiling height programmed for the system With the air pressured infusion the pressure will raise to 73 mmHg for anterior domain and 103 mmHg for posterior combined domains Select the Prime Test Vit button to activate the vacuum on right side aspiration line and test the pneumatic vitrectomy function The handpiece tip must be submerged in BSS during this process After the line has been primed this button will become Test Vit which will activate the cutter test without aspiration Select the Prime Tune U S button to activate aspiration on the left line and tune the fragmentation handpiece The electric connector on the fragmentation handpiece must be inserted into the Stellaris PC Vision Enhancement System and the tip submerged in BSS before this option is selected After the line has been primed this button will become Tune U S which will activate a shorter cycle of aspiration and tuning Select the Prime Aux button to activate aspiration to fill the left aspiration line with BSS After the first use subsequent
192. ons cable to the Ethernet connector of the MMC L labeled with the Stellaris PC Vision Enhancement System icon A WARNING Connecting the MMC data communication cable to equipment other than the Stellaris PC Vision Enhancement System may cause damage to both systems 5 Turnon the microscope camera and the video recorder and or monitor 110017276EN Rev B Operator s Manual 1 67 1 Getting Started 1 68 Operator s Manual 110017276EN Rev B 2 User Interface E User Interface This chapter introduces you to the basic operation of the Stellaris PC Vision Enhancement System The Anterior Domain system allows the use of phacoemulsification irrigation aspiration irrigation only and coagulation functions The Posterior domain allows the use of seven different functions posterior vitrectomy Fluid Air Exchange coagulation endoillumination fragmentation Air Forced Infusion and viscous fluid control The combined domain includes all function from both domains 2 1 Posterior amp Combined Domain Interface Controls Push Bar This is a single button control which displays a command and initiates that action when you select it No value is associated with this control and holding it down performs no additional function Figure 2 1 Sample Push Button Option List The Option List allows you to select an option A small x next to a setting indicates that additional choices are available and selecting the currently displ
193. ootpedal downward to Region 2 activates linear vacuum 1 ai Figure 4 2 Diagram showing two region pitch control programmed for Dual Linear Cut 1 Region 1 no active function 2 Region 2 Linear Vacuum The actual cut rate and vacuum level is displayed on the screen When the footpedal is released it returns to center and the cutter is disabled If enabled an audible linear tone indicates cut rate and vacuum level the pitch of the tone increases with increased cutter speed and vacuum level Figure 4 3 Foot control pop view to illustrate Dual Yaw Cut vitrectomy programmed for Right Foot 1 Pitch Movement to control linear vacuum 2 Outward Yaw to control linear cut Dual Linear Dual Yaw Vac This is a two region pitch and a yaw control mode Pressing the footpedal downward into Region 1 activates the vacuum with outward yaw Outward yaw while in Region 1 activates the vacuum without cutting Linear control of the vacuum is a function of footpedal yaw displacement Further depressing footpedal downward into Region 2 activates the linear cut rate 4 6 Operator s Manual 110017276EN Rev B 4 Detailed Reference The actual cut rate and vacuum level is displayed on the screen When the footpedal is released it returns to center where both vacuum and the cutter are disabled If enabled an audible linear tone indicates the cut rate and vacuum level the pitch of the tone increases with increased cutter speed and vacuum le
194. operation and on screen buttons The Main Surgical Screen can appear in one of two formats The default format is set as a surgeon preference To switch between levels click the A V More Button located at the top of the screen select the Screen Display Tab then select the desired Display Format Level Level I Display At Level 1 only the basic controls are displayed Figure 2 73 Surgical Screen display level 1 2 68 Operator s Manual 110017276EN Rev B 2 User Interface E A Note More Settings Screens for the Fluidics Ultrasound Coagulation and Vitrectomy functions are only available at Display format 2 Clock Menu The round Clock Menu in the middle of the screen can display up to 12 phases eight normal phases and four exceptions The exceptions appear on the left side of the clock menu against a darker background These are user defined to be any mode type Irrigation only Ultrasound Irrigation Aspiration Pneumatic Vit or Coagulation The Setup and End are the system function keys in the clock menu to change from surgical display screen to Setup and End Screens If you have the optional MMC system installed the center of the Clock Menu will show the video from the microscope camera when video is available You can select the video itself to switch between small and large video display formats See Chapter 3 for details on customizing your system 110017276EN Rev B Operator s Manual 2 69 2 User
195. or OFF In ultrasound mode outward yaw control could be programmed to toggle between different ultrasound submodes When the footpedal is released it returns to the center position Inward yaw movement controls reflux Dual Linear Setup The outward yaw movement provides linear control of the programmed function relative to footpedal displacement e g 0 to 15 displacement corresponds to 0 to 100 output When the footpedal is released it returns to the center position Inward yaw movement controls reflux Yaw Control of Reflux The footpedal may be programmed for use with either the right or left foot Reflux if selected is always activated by inward yaw displacement For a right foot configuration reflux is to the left inward For a left foot configuration reflux would be to the right Reflux may only be activated when aspiration is not activated Yaw Control of Ultrasound Submode For single linear setup the ultrasound submode sequence if programmed is activated by inward or outward yaw when the footpedal is in Region 2 or Region 3 In a Dual Linear Setup the yaw control of the ultrasound submode can only be activated if programmed by inward yaw when the footpedal is in Region 2 or Region 3 110017276EN Rev B Operator s Manual 1 57 1 Getting Started Linear Coagulation Control The control power is varied linearly from preset minimum to the preset limit Power begins when entering footpedal position 1 and ends at th
196. or to the user notification the Yellow area represents the point that the user notification has been given meaning that the lamp has a specific number of hours 15 until the indicated light bulb must be replaced Lamp Life Xenon 400 hours notification is at 15 remaining hours of lamp life Xenon Mercury S00 hours notification is at 15 remaining hours of lamp life 400 Lamp Replacement Procedure A WARNING Always turn off the power supply before attempting to replace the lamps to avoid danger of burns electric shock and eye damage from arc light 4 14 Operator s Manual 110017276EN Rev B gt 4 Detailed Reference E WARNING Wear eye protection when installing or removing lamps gt WARNING Do not touch the glass lamp or the circuit board Hold the assembly only by the outer metal gt housing WARNING Do not drop scratch or apply force to lamp as the high pressure inside may cause the lamp x E 3 4 110017276EN Rev B to rupture The Stellaris amp PC Vision Enhancement System will not work unless both lamps are fitted in place If you remove a lamp you must replace it with another lamp or the system will not function TURN OFF THE SYSTEM Wait 20 minutes for the system to cool before attempting lamp replacement Open the lamp replacement access door on the side of the unit by placing a coin or flat head screwdriver into the slot and turning it clockwise The dot should be
197. orce fluid through the handpiece into another beaker for proper disposal Do not draw flushing fluid back through the handpiece Disconnect the syringe Repeat Steps 3 through 7 at least three times Fill the syringe with air reattach to stopcock and push on the syringe plunger to force air through the handpiece Disconnect the syringe 5 8 Operator s Manual 110017276EN Rev B 5 Cleaning and Sterilization Requirements eee eee 10 Repeat Step 9 at least three times Ye ges Figure 5 6 Flushing Aspiration Lumen Ultrasound Handpiece 1 Handpiece 2 Fluid Pathway 3 Stopcock 4 Syringe Figure 5 7 Flushing Aspiration Lumen Fragmentation Handpiece 1 Fragmentation Handpiece 2 Fluid Pathway 3 Stopcock 4 Syringe 110017276EN Rev B Operator s Manual 5 9 5 Cleaning and Sterilization Requirements Needle Cleaning Instructions for reusable ultrasound needle only A Use a handpiece that was cleaned but not sterilized Attach the needle and a irrigation sleeve to the handpiece See page 5 6 Clean the needle in the same manner that the handpiece was cleaned in Steps C and D above Remove the irrigation sleeve and needle from the handpiece Ultrasound Handpiece and Accessories Sterilization A WARNING Before each use the handpiece and power cord should be inspected for damage nicks crimps dents exposed wires and so on If the handpiece is damaged it should be immediately removed from service Use of
198. ories and cables other than those specified by Bausch amp Lomb in the table below may result in increased electromagnetic emissions or decreased immunity to external electromagnetic radiation resulting in decreased patient safety As with all medical electronic equipment the Stellaris PC Vision Enhancement System should not be used adjacent to other equipment If adjacent use is necessary the Stellaris PC Vision Enhancement System should be observed to verify normal operation in the configuration in which it will be used A Note The Stellaris PC Vision Enhancement System includes functions that use high frequency signals for treatment including bipolar coagulation and pulsed phaco As with all systems using high frequency signals interference may occur between the bipolar function or the pulsed phaco function and other equipment If any physiological patient sensors are to be used in conjunction with the Stellaris PC Vision Enhancement System the phaco and bipolar circuits should be activated briefly prior to contact with the patient while the sensor operator is monitoring the output of the sensor If there is noise observed on the sensor the operator may adjust the sensor according to the instructions of the sensor manufacturer When phaco or bipolar functions and physiological monitoring equipment are used simultaneously on the same patient any monitoring electrodes should be placed as far as possible from the surgical electrodes
199. osal of standard electronic components and equipment 7 3 Warranty Information Stellaris PC Vision Enhancement System Warranty Bausch amp Lomb Incorporated warrants for the benefit of the purchaser only that the Stellaris PC Vision Enhancement System when delivered will conform to the manufacturer s then current version of the published specifications for the device in all material respects and shall be free from defects in material or workmanship for a period of twelve 12 months from the date of delivery when properly installed maintained and used for its intended purpose and in accordance with all manufacturer s instructions The exclusive remedy for any breach of this Warranty and Bausch Lomb s only responsibility therefore shall be at Bausch Lomb s option the repair or replacement of the non conforming defective equipment or component thereof Non conforming or defective parts may be either repaired or replaced with new refurbished or remanufactured parts at Bausch Lomb s sole discretion Any such non conforming or defective parts which are replaced by Bausch Lomb will become the property of Bausch Lomb Any service or replacement part provided under this Warranty may be supplied by Bausch Lomb or any of its affiliates or authorized service providers in Bausch Lomb s sole discretion Any claim based on this Warranty must be submitted to Bausch Lomb in writing within the twelve 12 month warra
200. ospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the Stellaris PC Vision Enhancement System requires continued operation during power mains interruptions it is recommended that the Stellaris PC Vision Enhancement System be powered from an uninterruptible power supply or battery Note U is the a c mains voltage prior to the application of the test level Power frequency 50 60 hz Magnetic field TEC 61000 4 8 8 6 Operator s Manual Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment 110017276EN Rev B 8 Specifications Guidance and Manufacturer s declaration electromagnetic immunity The Stellaris PC Vision Enhancement System is intended for use in the electromagnetic environment specified below The customer or the user should assure that it is used in such an environment IEC 60601 test level 3 Vrms 150 kHz 3 Vrms to 80 MHz Immunity Test Conducted RF IEC 61000 4 6 3 V m 80 MHz to 2 5 GHz Radiated RF IEC 61000 4 3 Compliance level Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the Stellaris PC Vision Enhancement System including cables than the recommended s
201. ous fluid extraction function SG04 Call your product service representative if this problem persists SG25 Confirm correct infusion and aspiration function SG04 Call your product service representative if this problem persists SG04 Call your product service representative if this problem persists SG25 Confirm correct infusion and aspiration function SG04 Call your product service representative if this problem persists Operator s Manual 6 5 6 Troubleshooting iD Type The internal air pressure is higher than CPX22 expected Warning CPX23 Info IV Pole Module Messages Text Message Suggested Action s Ensure system input pressure is 72 5 to 100 psi 5 0 bar 6 9 bar SG25 Confirm correct infusion and aspiration function SG31 Confirm correct vitrectomy function SG04 Call your product service representative if this problem persists Source pressure is high SG102 Decrease input pressure to 85 psi iD Type TextMessage Suggested action s The IV pole controller was not detected EIVO1 Warning in the system The motorized IV pole function is not available The IV pole controller software version is not compatible with this software nz Mane version The motorized IV Pole function is not available The IV Pole controller has failed to respond to a settings command The BINOS Warme module settings have been re sent to the module The IV pole controller has reset The
202. perator s Manual 3 7 3 Customizing Your System Figure 3 6 Customize Phase Screen Select Customize and more options specific to that function will appear and can be modified These can include Profile Foot Control Vacuum Infusion U S Setting U S Waveform Cut Coagulation and Visc tab Which tabs are displayed depends on which mode you are in and whether Customize Settings by Case is disabled or enabled as detailed in the table below Tabs Displayed on Phase Programming Screens Customize Setting By Case disabled 3 8 Operator s Manual 110017276EN Rev B 3 Customizing Your System i T Tabs Displayed on Phase Programming Screens Viscous Fluid Control Dual Yaw Vac submode Profile Foot Control Visc Vacuum and Infusion Extrude Profile Foot Control Vacuum Coag if Coag on Yaw is enabled Infusion Linear Coagulation Profile Foot Control Coag Mode Tabs Displayed on Phase Programming Screens Customize Settings by Case enabled A When you are done making changes select Exit Programming The system will ask you to confirm your changes before exiting 3 2 Surgeon Level Settings To access the surgeon level settings got to the Programming Screen then select Surgeon Settings the name of the surgeon file to be modified then Confirm Customize Foot Control To modify the techniques and settings for the Foot Control select the Foot Con
203. perator s Manual 8 5 8 Specifications Guidance and Manufacturer s declaration electromagnetic immunity The Stellaris PC Vision Enhancement System is intended for use in the electromagnetic environment specified below The customer or the user should ensure that it is used in such an environment Er IEC 60601 test i Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1kV differential mode 2 kV common mode 5 U 95 dip in U for 0 5 cycle 40 U 60 dip in U for 5 cycles 70 U 3096 dip in U for 25 cycles 596 U 29596 dip in U for 5 sec 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1kV differential mode 2 kV common mode 5 U 95 dip in U for 0 5 cycle 40 U 60 dip in U for 5 cycles 70 U 30 dip in U for 25 cycles lt 5 U gt 95 dip in U for 5 sec Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or h
204. produce the same result For Anterior modes the background will remain light grey Note Voice confirmation if enabled responds to Foot Control and remote operation and on screen buttons Clock Menu Setup Extrude Figure 2 37 Clock Menu The round Clock Menu in the middle of the screen can display up to 12 phases eight normal phases and four exceptions The exceptions appear on the left side of the clock menu against a darker background These are user defined to be any mode type Irrigation only Ultrasound Irrigation Aspiration Vitrectomy Coagulation or Viscous Fluid Control VFC The Setup and End are the system function keys in the clock menu to move from surgical display screen to Setup and End Screens 2 34 Operator s Manual 110017276EN Rev B 2 User Interface EH The global functions of bottle height Fluid Air Exchange air forced infusion illumination and fixed coagulation do not appear in the clock menu Sample screens with clock menus are shown in Figure 2 38 and Figure 2 39 o IV Pole e 50 A a lev m ek Ei ilum L D A m Figure 2 38 Vitrectomy Surgical Screen in Posterior Domain A Note When the case option is disabled in programming the surgical screen status bar will not show the case selection button When using Air Forced Infusion in the posterior and combined domains the air pump can be turned On Off in the Surgical or Setup screen When the air pump is off aspi
205. r application only optional accessory Handpieces packs and other accessories are supplied separately 110017276EN Rev B Operator s Manual 1 5 1 Getting Started n Bausch Lomb Stellaris PE Figure 1 3 Stellaris PC Vision Enhancement System Your Stellaris PC Vision Enhancement System was designed to be easily upgraded to take advantage of future technology evolution It includes an 19 inch 5 4 aspect ratio color touch screen display which is the primary interface between you and your system The display console may be tilted 10 degrees forward and 15 degrees back and swiveled 90 degrees to the right or left The brightness of the display is controlled through the A V More Screen see page 2 28 At the bottom of the screen is an infrared receiver which interfaces with the remote control The computer system includes both audio and visual capabilities which provide warning messages alarms and other audio indications as well as allowing you to view setup screens surgical settings and video from a microscope camera The volume is adjustable via the touch screen spin buttons on the A V More Screen Two USB ports on the back of the display allow you to save load and transfer your customized settings between systems A single port on the front of system provides filtered atmospheric air for both Fluid Air Exchange F AX and Air Forced Infusion AFI for posterior and combined surgery There are two air outputs b
206. r condition which if disregarded or incorrectly performed could result in damage to the product and or equipment Calls attention to an operating procedure practice or condition providing essential information Consult operating instructions Caution or warning to consult accompanying documents to avoid patient or operator hazard 110017276EN Rev B Operator s Manual Preface 3 Preface Direct Current Equipotential Ground Remote Control Reception Indicator Foot Control On TruLink Customer Support Network Access Dispose of Properly Serial Number Authorised Representative in the European Community Non Ionizing Electromagnetic Radiation Frequency in Hertz Fuse Microscope Camera Ethernet Monitor Stellaris PC Vision Enhancement System USB Preface 4 Operator s Manual HRE N 8 gt o INE 5 gt VA Alternating Current Foot Control Battery Battery Condition Indicator Manufacturer Date of Manufacture Caution Consult Accompanying Documents Type BF Applied Part Coagulation High Speed Vitrectomy Ultrasound Ohms Volt Amps Amperes 110017276EN Rev B Posterior Functions m a EQ Illum 1 9 VISC R ONLY IF ONLY LATEX Fluid Air Exchange Illumination Viscous Fluid Control 21 CFR 801 109 b Caution Federal USA law restricts this device to sale by or on the order of a physician Member Green Dot Scheme
207. r deionized water to flush the handpiece Irrigation and I A Handpiece Sterilization A WARNING Do not cold sterilize the instrument The sterilizing solution may not be flushed out prior to surgery and could be flushed into the eye resulting in serious eye injury CAUTION Allow 20 minutes after sterilization for the handpiece and cord to cool before using them again The handpiece connector must be completely dry before it is connected it to equipment Note To maintain flexibility and prevent cable damage wind the cord only loosely if needed and do not store it coiled with a less than 6 diameter The handpiece and any reusable accessories must be autoclaved before any item is used With the exception of flash sterilization the items may be wrapped in a surgical towel CSR wrap or equivalent The minimum requirements for sterilization are Standard Gravity Steam Sterilization Wrapped for 30 minutes at 121 C 104 8 kPa 1 048 bar 250 F 15 2 psi Flash Sterilization Unwrapped but covered for 10 minutes at 132 C 186 8 kPa 1 868 bar 270 F 27 1 psi High Vacuum Pre vacuum Sterilization Wrapped for 3 minutes at 134 C 206 8 kPa 2 068 bar 274 F 30 0 psi Refer to ANSI AAMI ST79 2006 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities and or your institution s policies regarding restrictions on the use of flash sterilization 110017276EN Rev B Operator s Manual 5
208. r in conjunction with this function 110017276EN Rev B Operator s Manual 4 23 4 Detailed Reference Silicone Oil When used in the injection mode the system can inject up to 5 cc of 1000 to 5000 centistoke silicone oil 24 C in less than 6 25 minutes Viscous Fluid Control Setup and Use Injection 1 Open a CX5720 disposable pack and place contents on a sterile surface 2 Connect the locking air connector on the tubing set to the Stellaris PC system Top right connector Figure 1 22 3 Connect the syringe coupler of the Viscous Fluid tubing to the syringe filled with silicone oil Twist the coupler to lock it securely to the syringe Refer to Figure 4 17 A WARNING Ensure a black piston is in the syringe before connecting the syringe coupler to the syringe filled with silicone oil Failure to do so will cause patient injury 4 Slowly turn the syringe upward so that the tip points toward the ceiling allowing any air to move to the tip in one cohesive bubble 5 While holding the syringe in the upright position remove the syringe cap from the syringe and attach the 19 ga Teflon cannula Teflon cannula is recommended for injection 6 Select Visc Inject from the Surgical Screen clock menu to perform the VFC injection procedure 7 To evacuate air from the syringe hold the syringe in the upright position and activate low injection pressure to force air out the tip of the cannula 8 Remove the cannula
209. r local Bausch Lomb representative to determine applicable return policies for your local market Bausch Lomb International Facilities Indicates Global Product Support Numbers Argentina Bausch amp Lomb Argentina S R L Av Juan B Justo 2781 1414 Capital Federal Argentina Tel 54 11 4856 4694 Fax 54 11 4857 1318 7 2 Operator s Manual 110017276EN Rev B 7 Service and Warranty Australia Bausch amp Lomb Australia Pty Ltd amp Surgical Level 4 113 Wicks Rd North Ryde NSW 1670 Australia Tel 61 2 9887 1444 Fax 61 2 9888 9642 Austria Bausch amp Lomb GmbH Horlgasse 12 Mezzanin TOP 5 1090 Wien Osterreich Tel 49 6221 823184 Belgium Bausch amp Lomb Uitbreidingstraat 46 2600 Antwerpen Belgium Tel 32 3 280 82 40 Fax 32 3 280 82 59 Bermuda Bausch amp Lomb Ireland Bermuda HQ Office Gibbons Bldg P O Box 1154 Hamilton HM EX Bermuda Tel 441 295 1044 Fax 441 292 6140 Brazil BL Industria Otica LTDA Rua Dona Alzira 139 91110 010 Porto Alegre RS Brazil Tel 55 5 1 3393 2000 Fax 55 51 3393 2100 BL Industria Otica LTDA Av Eng Luiz Carlos Berrini 1700 15 andar 04571 000 Sao Paulo Brazil Tel 55 11 3238 2900 Fax 55 11 5506 5528 110017276EN Rev B Operator s Manual 7 3 7 Service and Warranty e Canada Bausch amp Lomb Canada 520 Applewood Crescent Vaughan Ontario L4K 4B4 Canada Tel 905 695 7695 Fax 905 695 7656 Tel
210. r more information about where you can drop off your waste equipment for recycling please contact your local recycling office or electronic waste hauler Environmental Specifications Specifications Electrical Input Detachable international power cord Universal Input 100 240 VAC 50 60 Hz 1000 VA Equipotential grounding stud Fuse Set BL4352 includes 2 T 10AL 250V slow blow 5 mm x 20 mm fuses Temperature Ambient Operating Temperature 10 to 40 Celsius 50 to 104 Fahrenheit Ambient Storage Transport Temperature 20 to 60 Celsius 4 to 140 Fahrenheit Humidity Operating Humidity 3096 to 7096 Relative Storage Transport Humidity 10 to 98 Non Condensing Operates as rated up to 3 000 feet above sea level Shock Vibration Passes ISTA 3A and 3H Air Input Filtered medical grade air or medical grade nitrogen at 72 5 5 bar or 50 kPa to 100 psig Max 6 9 bar or 690 kPa and a flow rate of 2 25 SCFM 63 7 SLPM 110017276EN Rev B Operator s Manual 8 1 8 Specifications MMC Optional Specifications Specifications Electrical Input Detachable international power cord Universal Input 100 240 VAC 50 60 Hz 75 VA rating Fuse Type GDC T1 0 A 250V Physical Specifications Specifications Stellaris PC Vision Enhancement System 122 cm H x 45 7 cm W x 45 7 cm D excluding IV Pole and handle 48 in H x 18 in W x 18 in D 162 5 cm 64 in from floor to top of IV Pole Approximate Weight
211. rammed to control coagulation a Coagulation control will appear just to the left of the Foot Control display showing the current maximum power setting for the coagulation function When Linear Coagulation Mode is selected from the clock menu the same area of the screen will display linear coagulation settings 2 4 Customizing Your System Settings The Stellaris PC Vision Enhancement System has a programming interface through which you can program the system for your own preferred operating configuration and instrument parameters For details on how to program your system see Chapter 3 2 40 Operator s Manual 110017276EN Rev B 2 User Interface 2 5 Anterior Domain Basic Interface Controls Spin Button Pressing one of the arrows will increase up or decrease down a value to set a system parameter The current setting is displayed inside the spin buttons Pressing the displayed number will take you to the numeric keypad see page 2 3 so you can enter an exact number only if the surgical function is not currently in use Figure 2 43 Sample Spin Button Push Bar This is a single button control which displays a command and initiates that action when you select it No value is associated with this control and holding it down performs no additional function Confirm EEN Figure 2 44 Sample Push Bar Option List The Option List allows you to select an option A small next to a setting indicates that additio
212. rammed to provide linear control as a function of angular footpedal displacement Fixed Coagulation Setup and Use A WARNING Assure the handpiece and accessories are sterilized before use A WARNING Cables to the surgical electrodes should be positioned such that contact with the patient or other leads are avoided Note See Chapter 5 for cleaning and sterilization requirements when surgery is completed Specific instructions for cleaning and sterilization included with the handpiece or accessory take precedence over these instructions 110017276EN Rev B Operator s Manual 4 47 4 Detailed Reference HOi Figure 4 29 Fixed Coagulation Handpiece setup 1 Adaptor CX9404 2 To system coagulation connector 3 2 pin connector style 4 Lemo connector style 1 Connect the desired bipolar forceps or pencil to its cable You may need to use an adapter Connect the bipolar cable to the coagulation connector Use the spin buttons to adjust the percentage of coagulation power desired Be pes e The fixed coagulation function is activated by pressing the programmed Foot Control switch When the switch is released the function will deactivate Fixed coagulation mode is accessible during the system setup 5 If programmed a tone will signify bipolar coagulation operation Linear Coagulation Setup and Use A WARNING Assure the handpiece and accessories are sterilized before use as specified 4 48 Opera
213. ransmitter manufacturer Note At 80 MHz and 800 MHz the higher frequency range applies Note These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 6 8 Operator s Manual 110017276EN Rev B 8 Specifications G 8 2 Primary System Specifications Computer Unit Specifications Specification Display Assembly Computer Assembly 110017276EN Rev B Display Touch Screen Technology Flat Panel Liquid crystal display TFT LCD full color Size 19 diagonal Pixels 1280 x 1024 Physical Adjustment Tilt 15 up and 10 down Swivel 90 left and 90 right Brightness Controlled via touch screen Technology Resistive Analog Size Approximately 19 diagonal active area Environmental Chemical resistant to cleaning solutions Drip proof bezel Motherboard Technology IBM Compatible Pentium or better Computer hardware Hard Drive or Solid State Drive Two Audio Speakers Two USB ports Ethernet port Operator s Manual 8 9 8 Specifications Foot Control Specifications Specification General External components and housing are corrosion resistant Watertight housing Wireless control 10 m standard range Corded low voltage connection to system Non skid base 4 gray colored function switches Wall Charger 3 6v battery lithium Battery charging cradle Physical 12 22 cm 4 8125 in H
214. ration will be disabled 110017276EN Rev B Operator s Manual 2 35 2 User Interface Air Pump On Off button On state left has green light v F AX IV Pole i E DA n Le ES 2 ONE m Coag Cassette mm vd Figure 2 39 Phaco Surgical Screen in Combined Domain If you have the optional MMC system installed the center of the Clock Menu will show the video from the microscope camera when video is available You can touch the video itself to switch between small and large video display formats 2 36 Operator s Manual 110017276EN Rev B 2 User Interface Note the small on off buttons next to some functions on the Surgical Screens When the ring around the button is green the function is on When the ring is grey the function is off Note that Fluid Air Exchange and air forced infusion AFI are toggled when one function is on the other is off See Chapter 3 for details on customizing your system Vac E F AX IV Pole A amia on fe 200 Cassette nam VA Figure 2 40 Large Video Combined Surgery Screen 110017276EN Rev B Operator s Manual 2 37 2 User Interface ZZ Vac F AX IV Pol mmHg 3d 11 35 AM Timer IIS AM mee Q D s v mmHg pua Sg em L 200 m CH a Ant Vit Cassette nam v Figure 2 41 Small Video Combined Surgery Screen 2 38 Operator s Manual 110017276EN Rev B 2 User Interface BZ zZ IV Pole I
215. re Screen will not appear and the system will move directly to the Select Surgeon Screen as shown in Figure 1 7 6 Select Posterior Anterior Segment and the screen will transition to the Select Surgeon screen Skip this step if the system is already displaying the Select Surgeon screen 4 50 Operator s Manual 110017276EN Rev B 4 Detailed Reference 7 Select Surgeon s Name and then Confirm to transition to the Insert Cassette screen 8 Open the combined surgical pack with the following steps a Hold the bottom of the tray with left hand and the thumb placed in the thumb notch Circulating Nurse b Tearopen the Tyvek seal toward the body Circulating Nurse c Pour contents onto sterile surface Circulating Nurse d Identify loose components from the pre connected tubing set Scrub Nurse e Drape the system tray and screen with drapes provided Scrub Nurse f Arrange the pre connected tubing set with cassette bottle spike air tubing filter and actuation connector toward the system front The priming cup is placed at the other end with the tubing set in the middle as shown in the figure below Scrub Nurse Figure 4 31 Pre connected tubing set g Remove the tape to unbind all the tubing Scrub Nurse Straighten the tube set and secure it so it will not drop off the sterile surface Scrub Nurse i X Remove the tape from the cassette to release the additional tubing that is tied to
216. replacement lamp housing firmly into place 11 Screw the two lamp fasteners clockwise until tight thumbscrews A WARNING RISK OF ARC EXPOSURE 12 Replace the door before applying power to the System Make sure the dot is pointing down indicating that the door is locked 13 Turn on the system 14 Check that the new lamp is recognized 4 18 Operator s Manual 110017276EN Rev B 4 Detailed Reference Note Make sure to dispose of the old lamp properly Lamps are filled with high pressure xenon gas or xenon and mercury gases When disposing of the used lamp take appropriate measures in compliance with applicable regulations regarding waste disposal or entrust disposal to a licensed industrial waste disposal company Be sure to comply with the regulations in your country State region or province to ensure the used lamp is disposed of legally and correctly Fluid Air Exchange F AX Posterior Only The Fluid Air Exchange function provides continuous air flow from a pneumatic pump located in the compressor The air output connector must be used in the posterior mode for Fluid Air Exchange Air is filtered through a disposable filter The Foot Control side button may be programmed to turn Fluid Air Exchange On or Off Fluid Air Exchange Operation The Fluid Air Exchange mode is a posterior feature which provides the surgeon with the ability to instill a preset air pressure into the eye for Fluid Air Exchange It supports pr
217. ressure Ensure the irrigation clamp is open connect the irrigation and aspiration lines together and select Prime Select Show Me Steps for animated setup guide if needed Open the vitrectomy cutter pack connect the tubing and the actuation line to the pneumatic port on the Stellaris PC Vision Enhancement System Apply a pinch clamp not supplied at the end of the irrigation line to shut off irrigation flow when using the vitrectomy cutter without irrigation Do not close the clamp on the administration line Ensure the irrigation clamp is opened and the tip is immersed in irrigation solution then select Cutter Test After successful test select Advance to Surgery and the Main Surgical Screen will appear Planned Anterior Vitrectomy Use Select Vit from the clock menu The Show Me Steps animated setup guide will appear Use the spin control buttons to set the desired vacuum level and cut rate For Fixed cut vitrectomy yaw the footpedal outward to toggle the cutter on and off and depress the footpedal for aspiration An audio tone will signify cutter operation if enabled Fixed cut rate is activated in footpedal Region 2 For Linear cut vitrectomy activate the cutter by outward yaw travel of the footpedal in Region 2 For Reflux if enabled rotate the footpedal inward Unplanned Anterior Vitrectomy Setup In the event anterior vitrectomy is needed during phaco surgery 1 Select the Vitrectomy mode from the clock men
218. rol 1 burst at minimum duty cycle at start of linear control region Interval decreases until maximum duty cycle is commanded at end of linear control region Multiple Burst Ultrasound Mode Actual Duty Cycle Range is limited by the Burst Width Setting 8 16 Operator s Manual 110017276EN Rev B 8 Specifications Vacuum Fluidics Function Specifications Specification Provides Cassette Full Near Full and Continuous Fluid Level General Sensing Programmable vacuum response curves Modes of Linear control of vacuum o Ser Fixed On Off control of vacuum Aspiration P Dual Linear Modes Pitch or Yaw I A mode 0 mmHg to 600 mmHg Operating Phaco 10 mmHg to 600 mmHg Vitrectomy 0 mmHg to 600 mmHg Extrude 0 mmHg to 600 mmHg Vacuum Control 1 mmHg increments Gravity feed from I V bottle with pinch valve On Off control via Irrigation footpedal Gravity feed from I V bottle Reflux Control Modes Continuous Pulsed Activated via the Foot Control Linear Cut Rate Mode Range 30 to 5000 cuts per minute in cut per minute increments Operating Control Linear control of cut rate via the footpedal vi Parameters ee Fixed Cut Range 30 to 5000 cuts per minute in 1 cut per minute increments Rate Mode Cut rate is derated no more than 20 above 3000 feet Operating 915 meters altitude Parameters Control On Off control of cut via the footpedal The system will provide a minimum of 600 mmHg up to 3 000 feet 915 m above sea level A d
219. s Screen Tab The Viscous Fluid Control Settings Screen tab allows control of parameters for both injection and extraction The appearance of this screen will differ slightly depending on the current submode Injections will show minimum and maximum psi and extractions will show minimum and maximum mmHg The Foot Control preview will only appear when the fluid exchange is linearly controlled Figure 2 34 Viscous Fluid Control More Settings Screen tab 110017276EN Rev B Operator s Manual 2 31 2 User Interface Infusion More Settings Screen Tab The Infusion More Settings Screen tab allows control of parameters related to infusion the IV pole and pressurized air output port selection Figure 2 35 Infusion More Settings Screen tab 2 32 Operator s Manual 110017276EN Rev B 2 User Interface FF SSS Illuminator More Settings Screen Tab The Illuminator More Settings Screen tab allows you to control the settings for the fiber optic illuminator including range and filter usage Figure 2 36 Illuminator More Settings Screen tab 110017276EN Rev B Operator s Manual 2 33 2 User Interface 2 3 Posterior and Combined Domain Surgical Screen e Note A Layouts Following the successful completion of Prime and Tune the system will transition to the Surgical Screen with a dark background for posterior surgical modes Selecting Advance to Surgery from the Setup Screen would
220. s resulting from any ultrasonic handpiece may be the result of ultrasonic energy causing micro abrasion of the ultrasonic tip a Note The ultrasound needle must be properly installed and not defective and the irrigation and aspiration lines must be properly connected Note Hold the handpiece tip towards the ceiling while priming the irrigation line to insure all air has been removed You have connected the external components of your Stellaris PC Vision Enhancement System Now you are ready to set the operating parameters 1 From the Main Surgical Screen select the desired surgical mode from the clock menu 2 Use the spin control buttons to set the desired aspiration level and the ultrasound maximum power Set the desired number of PPS for pulsed ultrasound Note Assure all air bubbles are cleared from lines during priming Once the system has been primed ultrasound tuning will begin automatically and ultrasound tone will sound When complete the Main Surgical Screen will appear A Note As a matter of operator convenience priming is automatically cancelled when tuning has been completed or cancelled Re tune if either the handpiece or ultrasound needle is changed 3 Press the footpedal to begin ultrasound operation Aspiration and ultrasound power will be applied as the footpedal enters their pre programmed regions as described in Chapter 3 4 The Actual Vacuum displays the vacuum being used in relation to the maxi
221. s that can be used That limit is the lesser of the number of characters in the table below or the number of characters displayable in the corresponding area on the screen Maximum Characters Pathology Submode 2 4 Operator s Manual 110017276EN Rev B 2 User Interface E Eject Cassette To eject the fluidics cassette select the upward pointing arrow to the left of the cassette icon shown below Cassette Figure 2 9 Eject Cassette button Foot Control Indicator The image of the Foot Control on the screen shows the status of the Foot Control Operation The yellow dots indicate that the Footpedal Yaw is activated The numeric display on the pedal indicates the Footpedal position Figure 2 10 Foot Control Indicator 110017276EN Rev B Operator s Manual 2 5 2 User Interface Pop Up Message Window This type of window displays error and warning messages You should take the appropriate action before continuing system operation Nothing else can be done on the screen while a pop up window is on the screen The surgeon may be able to continue with the procedure once the error has been rectified Step 1 System not detecting the foot controller Suggested Action Use the wired cable connection to the system Lee VE Figure 2 11 Sample Pop Up Message Window For each message displayed suggested actions to resolve the condition are displayed If more than one suggested action is availab
222. se Menu Posterior and Combined and choose the specific technique needle grade and pathology Anterior Domain or vitrectomy gauge fragmentation needle Posterior Domain for the current procedure The appearance of this screen will differ for the three possible domains as shown in Figure 1 8 Figure 1 8 Anterior Domain Select Case Screen 110017276EN Rev B Operator s Manual 1 13 1 Getting Started Gum Qna Progra mm ret c ees iy Select Procedure Uma x 1 I Advance to Soio t regi Surgery ui ree u KI H Whine Case and Tune Menu Insert Cassette a Cong 5 Figure 1 9 Posterior Domain Case Menu Screen 1 14 Operator s Manual F AX IV Pole dr iium 110017276EN Rev B Step 1 7 1 TT tri 1 Getting Started ara oe O e Qv H ep Pree re teen mt Gelect Procedure Advance to Surgery Prime Case and Tunc Menu a Cong 5 Figure 1 10 Combined Domain Case Menu Screen Advance to the open pack step by selecting Open Pack Insert Cassette Anterior Domain or Insert Cassette Posterior or Combined Domain from the clock menu 110017276EN Rev B Operator s Manual 1 15 1 Getting Started 1 5 Starting a New Procedure The Stellaris PC Vision Enhancement System is user friendly and will highlight whichever step is next in a typical procedure The st
223. sentative to have the Foot Control calibrated SG36 Change the Foot Control home position switch selection SG37 Confirm that the correct surgeon settings are loaded If incorrect select Setup then select Select Surgeon to select the correct surgeon settings SG36 Change the Foot Control home position switch selection SG37 Confirm that the correct surgeon settings are loaded If incorrect select Setup then select Select Surgeon to select the correct surgeon settings SG38 Reposition the Foot Control and ensure that the center pedal and buttons are not activated SG34 Replace the Foot Control with another Foot Control using the wired cable connection to the system SG04 Call your product service representative if this problem persists SG40 Initiate wireless Foot Control connectivity by pressing one of the Foot Control buttons momentarily the left LED will light up SG33 Use the wired cable connection to the system SG34 Replace the Foot Control with another Foot Control using the wired cable connection to the system Operator s Manual 6 15 6 Troubleshooting iD Type TextMessage suggested action s SG34 Replace the Foot Control with The Fost Contiols ftware versionis not another Foot Control using the wired cable WFC09 Warning compatible with this software version connection te ie ey sent SG02 Call your product service Surgical mode is not available representati
224. stalled before using Select Prime and Tune on the Setup Screen 4 34 Operator s Manual 110017276EN Rev B 4 Detailed Reference Description of Ultrasound Modes The application of ultrasound power may be fixed or linear Linear power is proportionally controlled by the footpedal between zero and the maximum limit set on the console Ultrasound power may be adjusted from 0 to 100 in 5 increments using the up down spin buttons Foot Control buttons or remote and 1 increments using the keypad The ultrasound output will be activated at the minimum programmed power level as the footpedal moves into the active ultrasound region and will increase to the maximum programmed output as a function of linear footpedal travel Single Linear Ultrasound Mode with Fixed Aspiration Once irrigation has been initiated and the footpedal has been depressed approximately five degrees or as programmed an increase in footpedal resistance will be noted signifying the transition from Region 1 to Region 2 and the start of aspiration Fixed aspiration will be developed at the selected aspiration level The screen will display the actual amount of aspiration at any given time Ultrasound power is activated in Region 3 of footpedal travel Another momentary increase in footpedal resistance will be noted if detents are enabled signifying the transition from one Region to the next and the start of ultrasound power Ultrasound power will be initiated and control
225. subio 34 20050 Macherio Milan Italy Tel 39 039 20731 Fax 39 039 2010081 Tel 39 039 207 3744 Tel 39 039 207 3308 Fax 800 17 3931 110017276EN Rev B 7 Service and Warranty EH Operator s Manual 7 5 7 Service and Warranty m Japan Bausch amp Lomb Japan Ltd Tower B Omori Bellport 6 26 2 Minami Oi Shinagawa ku Tokyo 1400 0013 Japan Tel 81 3 5763 3700 Fax 81 3 5763 4003 Korea Bausch amp Lomb Surgical 11F Cannon B D 168 12 Samsung dong Kang namgu Seoul Korea Tel 822 558 2988 Fax 822 642 1586 Malaysia Bausch amp Lomb Malaysia Sdn Bhd 3rd Floor Bangunan THK Lot 2A Jalan 243 51A 46100 Petaling Jaya Selangor Darul Ehsan Malaysia Tel 60 3 7680 8828 Fax 60 3 7680 887 1 Mexico Bausch amp Lomb Mexico SA de C V Av Santa Fe 505 Piso 6 Colonia Cruz Manca Santa Fe Delegacion Cuajimalpa Mexico D F C P 05349 Tel 52 55 30 67 4600 Fax 52 55 30 67 4658 Tel 52 55 3067 4611 7 6 Operator s Manual 110017276EN Rev B Netherlands Bausch amp Lomb B V Koolhovenlaan 110 1119 NH Schiphol Rijk The Netherlands Tel 31 20 65 54 500 Fax 31 20 65 37 871 Tel 31 20 65 54 555 Fax 31 20 65 37 873 New Zealand Bausch amp Lomb NZ Ltd 2A Fisher Cresent Mt Wellington Auckland New Zealand Tel 64 9 259 2762 Fax 64 9 259 4067 Philippines c o address in Singapore see Singapore Portugal Bausch amp Lomb S A Sucursal Portug
226. t System requires continued operation during power main interruptions the system should be powered from an uninterruptible power supply not provided In the event the power source is interrupted causing the system to shut down the cassette will be ejected automatically Perform the steps listed below according the type of surgery Anterior Segment surgery Remove the handpiece from the eye safely and pinch off the irrigation clamp to stop fluid flowing into the cassette Posterior segment surgery Remove handpiece from the eye safely use sclera plugs to stop fluid leakage from the eye Pinch off irrigation clamp only after sclera plugs have been inserted to prevent fluid leakage When the power supply resumes reboot the system insert a cassette open the irrigation clamp and perform prime and tune according the system setup procedures see page 1 19 110017276EN Rev B Operator s Manual 1 29 1 Getting Started 1 10 Moving Your System to Another Location A WARNING Do not transport or move your system from room to room or up an inclination unless you have followed the steps below This unit is designed to provide mobility within the environment of the operating room Care must be taken as to avoid sloped floors greater than 5 degrees angle during use Before transporting the unit from room to room or for any more extensive moving follow the basic safety instructions Ne upo co Sr A Note Power down normall
227. t is turned off before making any connections Position the MMC on a flat surface near the video monitor and or recorder to be used A WARNING The MMC is not to be placed inside the patient environment A CAUTION Do not place the MMC on devices that radiate heat A CAUTION The MMC may be damaged if fluids are spilled on the outer enclosure Figure 1 43 Multimedia Center MMC rear panel 110017276EN Rev B Operator s Manual 1 65 1 Getting Started 109 240v rv 5o GOMz 50 v Figure 1 44 Labeled MMC Rear 1 S Video 2 FireWire 3 Input from Microscope camera 4 Ethernet TruLink Customer Support Network Connector 5 Power Input 6 For Service Only 7 USB Ports For Service Only 8 Input from Stellaris PC Vision Enhancement System 9 Output to Display Monitor 10 Composite Video Figure 1 45 MMC connections 1 Internet Intranet Connection 2 AC Electrical Power Source 3 Optional Connection Without Recording Device 4 Video Camera Not Supplied 5 Optional Recorder Not Supplied 1 66 Operator s Manual 110017276EN Rev B 1 Getting Started E 1 Connect the detachable power cord B to the MMC and plug it in to the AC power source A WARNING Do not plug the MMC into multiple portable socket outlets or extension cords 2 Connect the video input cable D from the surgical microscope camera to the VIDEO IN connector use the included RCA Plug to BNC Jack adapter if necessar
228. t or pulse duration for 2 ms to 20 ms by 2 ms Phase Case burst modes or fixed pulse 20 ms to 80 ms by 5 ms modes 80 ms to 600 ms by 20 ms 110017276EN Rev B Operator s Manual 3 33 3 Customizing Your System e Options Ranges Step Sizes Bra Burst interval for fixed pulse modes Maximum duty cycle for multiple burst modes 2 ms to 20 ms by 2 ms 20 ms to 80 ms by 5 ms 80 ms to 600 ms by 20 ms 50 to 99 by 5 Subject to a minimum off time of 2 msec and a maximum off time of 1500 msec Phase Case Phase Case Waveform Ultrasound Disabled Enabled Phase Case Phase Case Phase Case Phase Case Linear control power minimum level Minimum duty cycle for multiple burst modes Foot control mapping for linear control front loaded linear back loaded Waveform Type Waveform duration 0 to 10 by 1 10 to 30 by 2 30 to 100 by 5 1 to 10 by 1 10 to 30 by 2 30 to 50 by 5 Subject to a minimum off time of 2 msec and a maximum off time of 1500 msec Linear Front Loaded Back Loaded Ramped not programmable 250 ms to 1000 ms by 50 ms resolution of 50 ms even with calculator Waveform Depth 25 to 100 by 5 Pulsed mode linear pulse rate 1 PPS to 20 PPS by 1 PPS minimum Pulsed mode linear duty cycle minimum Burst mode linear duration minimum Foot control mapping for second ultrasound linear control 3 34 Operator s Manual 20 PPS to 50 PPS by 5 PPS 50 PPS
229. t output Figure 1 42 Phototoxic sensitivity vs light wavelength 1 Phototoxic sensitivity 2 Filtered in Stellaris PC 3 Aphakic hazard weighting function 4 UV 5 Visible Note that the xenon lamp has a greater phototoxic effect than xenon mercury for the same apparent brightness 1 62 Operator s Manual 110017276EN Rev B 1 Getting Started E Time dependency The risk of developing photoretinitis depends not only on the intensity of light but also on the duration of the exposure i e the total dose of intensity times duration must be limited to prevent damage This applies to an uninterrupted beam at a particular point on the retina Normal surgical procedures do not involve exposure to a single point on the retina and movement of the light guide would be expected to extend the time before which photoretinitis might occur A CAUTION The light emitted from this instrument is potentially hazardous see third note below The longer the duration of exposure the greater the risk of ocular damage Exposure to light from this instrument when operated at various outputs may exceed the safety guideline after the times listed in the table below when used with a Bausch Lomb focal type probe Time to exceed 10 J cm weighted radiant exposure guideline in minutes at a working distance of 15 mm tamp Mercury p EIERES ERE PI LS 8 m p pem gt 10 40 M 3 EMI Default EN EXE 2120 2120 Setting x gt m w EN
230. tacle See Figure 4 7 Scrub nurse or Circulating nurse Figure 4 7 Connecting fiber optic connector to the illumination port 1 Connector groove 2 Connector groove align with port receptacle when it is properly connected 2 To turn illumination on select the On Off button from the screen as shown in the figure below Scrub nurse or Circulating nurse 4 12 Operator s Manual 110017276EN Rev B 4 Detailed Reference E Figure 4 8 Illumination control showing a green ring around the On Off button which indicates the lower illumination port right is turned on The filter button is below the on off button for the lower right lamp 3 Usethe on screen control to adjust the intensity e Note Lamp may take several minutes to complete the warm up but can be used once a required intensity has been reached Note Never turn the illumination on and off rapidly 4 Setthe illumination output with the up down buttons in the display tube Click on the arrow to increase or decrease the output level or click and hold to make larger changes Note Should the light source fail during use the operator must switch the fiber optic illuminator to the other lamp port The burned out lamp should be replaced before the next surgery Illumination Filter Control The lower lamp has 3 optional filters that can be used You can change the current filter using the touch screen display and foot control if programmed appropriately
231. tage 120V Range Programmable from 0 to 100 in 1 increments Control On Off control via the footpedal Operator s Manual 8 13 8 Specifications 8 7 6 3 4 1 2 3 2 1 0 100 200 300 400 500 600 700 800 2900 1000 3 160 120 s Mn 9 804 8 40 0 4 1 100 10 Figure 8 1 1 Bipolar Power vs Load 2 Power watts 3 Load ohms 4 Power out 5 Load 6 Setting 7 Settings 8 Maximum Possible Peak Coagulation Output Voltage at all Output Control Settings and Both Modes 9 Peak Output V 10 Output Control Setting 96 11 Linear and Fixed Control 8 14 Operator s Manual 110017276EN Rev B 8 Specifications E Ultrasound Function Specifications Specification Ultrasound Time System records and displays ultrasound time in 0 01 second increments Tuning System provides one step tuning Self Special Features adjusts to resonant frequency of handpiece Probe Present System provides a probe present detection system Wave form ultrasound available Type Floating BF Connection Programming Levels 1 2 3 Continuous ultrasound Pulsed ultrasound Fixed pulse ultrasound Single burst ultrasound Multiple burst ultrasound Modes of Operation Programming Level 3 only Dual Linear Ultrasound Linear Power Linear Pulse ultrasound Linear Power Linear Duty Cycle ultrasound Dual Linear Multiple Burst ultrasound Variable Power Multiple Burst ultraso
232. terface Controls eese 2 1 Posterior and Combined Domain Surgical Information More Settings Screens sss 2 7 Posterior and Combined Domain Surgical Screen Layouts eee 2 34 Customizing Your System Settings ea una 2 40 Anterior Domain Basic Interface Controls trt e er pe P HL Sp nk 2 40 Anterior Domain Surgical More Settings Screens sese 2 46 Anterior Domain Surgical Screen Layout asien 2 67 Customizing Your System Settings roseo entire epe eren Ee NEEN SE aE aare entre 2 15 Customizing Your System hAEUEPCNISIDDIME ES 3 3 Surgeon Level Set ngs 4 uie dre ro i e n t Eee GEI ERE aE araa A n S ois 3 9 lu EUER INDUIT een nina ne an 3 14 System EE 3 18 RRE EE 3 22 System Gn ss 3 22 TruLankG Customer Support Network idea Nees senken 3 24 Customization Levels gd 3 27 110017276EN Rev B 4 3 1 5 2 5 3 5 4 5 5 5 6 1 6 2 6 3 6 4 6 5 6 6 6 7 1 722 7 3 7 4 7 5 7 8 1 8 2 8 3 8 9 1 9 2 0 3 9 Detailed Reference Advanced Vacu miSystenFIuldics cui oae SR itte et TR ee ernten ke 4 1 Posterior be breet es eer Seege ege 4 5 Antenor EH DIE een in S E 4 29 Coagulation Function Posterior amp Anterior Modes nnne 4 46 Combined Blunt RET n 4 50 Cleaning and Sterilization Requirements Dionis e E
233. the IV Pole or use the IV Pole as a handle The Stellaris PC Vision Enhancement System IV Pole is an integral part of the system console It can be directly moved up down or to a specific preset height by any of several methods It can be controlled through the touch screen Foot Control if programmed remote control optional accessory or directly by using the buttons on the back of the system console The IV Pole can also be pre programmed to a certain height for various surgical modes The system will not compensate if the bottle height is altered though the use of IV Pole extensions or other hardware not provided with the system To change the bottle height during surgery use the up and down arrows on the IV Pole control section of the Surgical Screen See page 2 39 or use the buttons on the back of the system console In the lowest stowed position and with a 500 ml bottle the IV Pole will provide approximately 30 cm 12 in of infusion pressure measured from the aspiration port to the middle of the BSS drip chamber This is an equivalent pressure not Intraocular Pressure of 22 4 mmHg The IV Pole can extend to 140 cm 55 in high an equivalent pressure of 102 74 mmHg To change the programmed bottle height settings for the current surgical mode select the Fluidics More Settings Screen page 2 32 ifin Posterior Mode orthe Vacuum Fluidics More Settings Screen See page 2 19 then select the Infusion Tab to change the actual h
234. the Zero Level hanger if using AFI Squeeze and release the drip chamber until it is half filled with solution For AFI setup use the spiking tool provided to puncture the rubber stopper on the bottle before inserting the metal cannula into the bottle Circulating Nurse See Figure 4 5 Figure 4 5 AFI Setup instructions 1 Spiking tool 2 Remove cover 3 Spike bottle with spiking tool 4 Spike AFI spike into the bottle o Remove the tape on the priming cup Scrub Nurse p Place the priming cup flat on the tray as in the figure below Scrub Nurse 110017276EN Rev B Operator s Manual 4 9 4 Detailed Reference Figure 4 6 Priming cup with infusion cannula left aspiration and vitrectomy cutter attached 9 Select the first button from the Easy Prime selection menu to initiate the auto priming and vitrectomy cutter test sequence Scrub Nurse or Circulating Nurse Note The system will not provide feedback as to whether or not fluid is present during priming Inspect tubing and confirm that it is filled with fluid and free of bubbles after each Prime and Tune Repeat the priming process if the tubing is not adequately filled with fluid There are three settings to control infusion On Off in Posterior modes of surgery and they are Manual Auto On Off Auto On In Manual Infusion Mode infusion is activated and deactivated by using the button on the GUI screen or one of the Foot Contro
235. ther type of lamp in either position The probe connector contains a shutter mechanism to prevent light leakage when the probe is not connected 110017276EN Rev B Operator s Manual 4 11 4 Detailed Reference The light transmitted to the patient will have a spectral content between 435 nm and 650 nm Each lamp provides slightly different illumination and the choice of which to use will be dependent on both surgeon preference and procedure type The xenon lamp has a whiter light with a full spectrum The xenon mercury lamp has a greener light that has less blue light content than the xenon spectrum at the same perceived light level If a xenon lamp is installed in the lower position the user may select one of three color filters green yellow amber to tint the light output to give improved visualization in certain circumstances The Foot Control side button may be programmed to turn lamp 1 or lamp 2 on and off There are three ways to map the illuminator settings to the Foot Control 1 Using the foot control tab of the More Settings Screen W 2 Programming the technique level foot control settings 3 Overriding the technique level settings on the phase level foot control settings screen in programming also Illumination Setup and Use 1 Connect the fiber optic illuminator to the desired port see Figure 1 22 Push the connector into the port until the groove on the connector is aligned with the front surface of the port recep
236. this switch off until the system has been properly shut down gt CAUTION Do not disconnect system from power while in use Connect the air supply to the back bottom of the system CAUTION Observe system diagnostic messages when powering up system for first use each day and take appropriate action if required Also observe first cassette priming or calibration phaco frag handpiece tuning and or vitrectomy handpiece testing for correct completion 1 8 Operator s Manual 110017276EN Rev B 1 Getting Started Figure 1 4 Back bottom of system 1 Main Power Switch e Note The system requires filtered medical grade air or medical grade nitrogen at 72 5 to 100 psig 500 to 690 kPa or 5 0 to 6 9 bar and a flow rate of 2 25 SCFM 63 7 SLPM Press the power button on the front of the system and wait for the screen to come on and the animation to finish The front power switch is brighter when the system is off and dims when you turn the system on The Stellaris PC Vision Enhancement System performs a self check each time the power is turned on The system automatically checks its configurations for any changes since the last time it was turned on A Note When turning the system on for the first use ofthe day pay close attention to any warning messages that appear on the screen and address any issues After the Foot Control has been synchronized to the specific Stellaris PC Vision Enhancement System See pag
237. tion on Yaw Reflux Type and Fixed Coag Power Selecting ix next to any of these options will open a list of additional selectable options Phaco u Unearus Le qu Jitrasouna fusion I iuminstors Vaecuut Figure 2 28 Footpedal More Settings Screen Tab 2 24 Operator s Manual 110017276EN Rev B 2 User Interface E Select Default Button Grouping in the middle of the screen at arrow provides a selection of default button groupings for toe heel Foot Control buttons The default button groupings are shown in the table below Foot Control Upper Left Upper Right Lower Right Switches default configuration Fixed Coagulation Next Phase Elevated Infusion Reflux On Off Fixed Coagulation Irrigation On Off None Fixed Coagulation Irrigation On Off When the foot control button is programmed to change infusion pressure pressing on the button will change infusion settings until it is released Irrigation On Confirm Settings Increment bottle Decrement bottle Off anterior or height anterior or height anterior Fixed Coagulation Increment Infusion or Decrement posterior Pressure Posterior Infusion Pressure combined and Combined Posterior and Combined 110017276EN Rev B Operator s Manual 2 25 2 User Interface The Regions button shows the current settings for the footpedal pitch regions and detent options You can modify the starting depression position for each region
238. tomizing Your System This chapter explains how to customize your Stellaris PC Vision Enhancement System to achieve maximum flexibility for your operating needs A Note Surgical devices may not be operated during programming Each surgeon using the Stellaris PC Vision Enhancement System can program the system for their own preferred operating configuration and instrument parameters Several default surgeon preference files are pre loaded on the system and you may copy and modify any of them using the Programming interface You can create modify and backup surgeon setting preference files as well as modify system parameters To program system parameters select Programming from the main clock menu on any setup screen The Main Programming Screen will appear from which you can perform the following functions Manage Surgeon Settings System Setup System Configuration System Calendar e TruLink amp Customer Support Network optional function 110017276EN Rev B Operator s Manual 3 1 3 Customizing Your System Figure 3 1 Main Programming Screen Each of these functions is described in more detail below At any time you can select Programming to return to the Main Programming Screen or Exit Programming to return to the Select Surgeon Screen or the Setup Surgical Screen In either case the Stellaris PC Vision Enhancement System will ask if you want to save any changes you have made Select Yes to save your changes an
239. tor s Manual 110017276EN Rev B 4 Detailed Reference EE Note Specific instructions for cleaning and sterilization included with the handpiece or accessory take precedence over these instructions Note See Chapter 5 for cleaning and sterilization requirements when surgery is completed Note Due to compliance with IEC 60601 2 2 position 1 will not start until approximately 35 of pedal travel is attained in the linear coagulation mode C LH EI 3 I JE i 4 e Figure 4 30 Linear Coagulation Handpiece Setup 1 Adaptor CX9404 2 To system coagulation connector 3 2 pin connector style 4 Lemo connector style 1 Connect the desired bipolar forceps or pencil to its cable The use of an adapter may be necessary 2 Connect the bipolar cable to the coagulation electrical connector if required 3 Select Coag from the clock menu 110017276EN Rev B Operator s Manual 4 49 4 Detailed Reference SS B 4 Use the spin buttons to adjust the Max Coagulation power desired 5 Thelinear coagulation function is actuated by the footpedal if programmed The Actual Coagulation progress bar will display the amount of coagulation power being used in relation to the maximum setting 6 A tone will signify bipolar coagulation operation if programmed 4 5 Combined Domain The Stellaris PC Vision Enhancement System supports combined procedures to allow user perform both posterior and a
240. trasound handpiece 110017276EN Rev B Operator s Manual 5 7 5 Cleaning and Sterilization Requirements __ _ __ _ SS 3 Push on the syringe plunger to force fluid through the handpiece into another container for proper disposal Do not draw flushing fluid back through the handpiece Disconnect the syringe Repeat Steps 1 through 3 at least three times Fill the syringe with air reattach to infusion line and push on the syringe plunger to force air through the handpiece Disconnect the syringe Repeat Step 5 at least three times Figure 5 5 Flushing Ultrasound Handpiece 1 Syringe 2 Handpiece D Flush the aspiration lumen as follows see Figure 5 6 and Figure 5 7 below L Si n St dee Ge From the rear of the handpiece insert aspiration brush provided in the Universal Maintenance Kit CX7120 into the aspiration fitting Push the brush bristles through the handpiece aspiration lumen then pull the brush back out Thoroughly clean the brush after each use and sterilize at the end of each day according to the maintenance kit instructions Refill the syringe to the 50 cc ml mark with warm 30 C to 40 C or 85 F to 105 F distilled or deionized water Connect the syringe to the center stopcock fitting Rotate the stopcock lever to allow fluid flow to the female luer fitting Connect the stopcock female luer fitting to the handpiece aspiration fitting Push on the syringe plunger to f
241. trol Next U S Ultrasound Modulation on Yaw Reflux Type and Fixed Coag Power Editable functions are highlighted with a blue or gray background and marked with a Next US Medutation On Yaw D Sage Aetrex sa Yaw 4 Erstes Dual Linear Control Asp en Yaw Figure 2 66 Foot Control More Settings Screen 110017276EN Rev B Operator s Manual 2 61 2 User Interface IS The Regions Tab shows the current settings for the footpedal pitch regions and detent options You can modify the starting depression position for each region Figure 2 67 Foot Control More Settings Screen Regions tab 2 62 Operator s Manual 110017276EN Rev B 2 User Interface The Status Tab shows the current status of several footpedal options including communication status battery status and signal strength Foot Comtret em CAm Ges Ceeecctud Pitch Acastemce e omms e anna gege charus es 68 qom ser N Figure 2 68 Foot Control More Settings Screen Status Tab 110017276EN Rev B Operator s Manual 2 63 2 User Interface A V More Settings Screen The A V More Settings Screen allows you to change many aspects of the audio and video display Each tab allows you to change the settings and configuration for aspects of the display The Audio Tab controls the master volume for the system as well as the specific tone and volume used for each of the following events Irrigat
242. trol Tab on the Surgeon Level Programming Screen You can set the Foot Control for right or left foot operation The Mode Change Control allows you to set the Stellaris PC Vision Enhancement System response when the footpedal is activated and you change surgical modes Options are Allow Limit Pedal Allow Range Pedal Allow No Limiting and Not While Active The Detent Control determines what feedback the Stellaris PC Vision Enhancement System will give when changing footpedal regions This can be disabled Enabled for regions 1 2 and 3 or Enabled for regions 2 and 3 only The Region Spin Control Buttons controls at what percent depression at which each region begins In combined configuration systems a button is displayed that allows selection of Posterior Modes or Anterior Modes When Posterior Modes is selected the footpedal region 1 and 2 start positions are adjustable The posterior mode start positions are used in the posterior domain and the posterior modes of the combined domain 110017276EN Rev B Operator s Manual 3 9 3 Customizing Your System When Anterior Modes is selected the footpedal region 1 2 and 3 start positions are adjustable The anterior mode start positions are used in the anterior domain and the anterior modes of the combined domain In posterior only configuration systems the Posterior Modes Anterior Modes button will not be displayed and only the footpedal region 1 and 2 start positions will be adjustabl
243. u The Show Me Steps animated setup guide will appear Select Close to close the animated setup guide Open the appropriate vitrectomy cutter pack For the pneumatic cutter connect tubing and the actuation line to the pneumatic port on the Stellaris PC Vision Enhancement System Ensure that the irrigation clamp is open and the tip is immersed in irrigation solution Select Setup then Pneumatic Vit Test Select Show Me Steps for animated setup guide if needed After a successful test select Advance to Surgery and select the Vit phase from the clock menu 110017276EN Rev B Operator s Manual 4 41 4 Detailed Reference Foot Control of Anterior Vitrectomy Mode As the footpedal is initially pressed the irrigation control valve will open to allow irrigation into the eye Once irrigation has been initiated and the footpedal has been depressed approximately five degrees or as programmed a momentary increase in footpedal resistance will be noted signifying the transition from Region 1 to Region 2 and the start of aspiration Aspiration increases proportional to footpedal travel with the maximum level being set via the Max Vacuum input on the touch screen Region 2 will provide linear control of aspiration The Actual Vacuum display will indicate the current aspiration level If enabled an audible linear tone will indicate aspiration The pitch of the tone increases with increased aspiration For Fixed Cut vitrectomy mode vitreous c
244. ual It also provides information on setting up your Stellaris PC Vision Enhancement System and making the necessary connections Ad DANGER Do not use this device in the presence of flammable anaesthetics A WARNING Implantable defibrillators present a risk of injury if triggered by a fibrillatory event during intraocular surgery due to involuntary motion by the patient Patients being considered for intraocular procedures must be questioned to determine if they have such a device and if so the defibrillator manufacturer must be consulted to determine the appropriate action A WARNING Electromagnetic interaction between the phacoemulsification phaco handpiece and an implanted cardiac pacemaker is unlikely but cannot be ruled out Patients should be questioned to determine if they have such an implant and if so the manufacturer of the implant should be consulted to determine the proper course of action A WARNING All external wiring must be in accordance with local electrical code requirements and NEC Class II signaling system twisted wire with outer shield The wire length must not exceed 20 meters 60 feet The wire gage must be 26 AWG to 12 AWG gage with ends stripped from 9 mm to 10 mm 3 8 inch At no point should the wire be untwisted more than 5 cm 2 inches A WARNING Patient not to come in contact with earthing metal parts A WARNING Avoid skin to skin contact A WARNING Grounding reliability
245. uct service has failed representative if this problem persists LMI3 Warning The lower illuminator brightness control SG04 Call your product service has failed representative if this problem persists LMI4 The illuminator bulb type is not valid SE EE The upper illuminator fan has failed LMI6 Warning Illuminator use may be limited if overheating occurs The lower illuminator fan has failed LM17 Warning Illuminator use may be limited if overheating occurs 110017276EN Rev B LM06 LM07 LMO0S8 SG04 Call your product service representative if this problem persists SG04 Call your product service representative if this problem persists Operator s Manual 6 7 6 Troubleshooting iD jType Text Message Suggested Action s The upper illuminator has a bulb ballast LMIS8 Warning error and cannot be used It will be SOOLI E Bees representative turned off in 30 seconds The lower illuminator has a bulb ballast LMI19 Warning error and cannot be used It will be icr your Geen representative turned off in 30 seconds LM21 he aminao WA Polge SG95 Replace the lower illuminator bulb The illuminator ballast fan has failed SG04 Call vour product service LM23 Warning The illuminators will be turned off in d Ln representative if this problem persists 30 seconds The upper illuminator bulb is at end of 2 LM24 Bite Lamp wiil be disdbled3t imed oi SG94 Replace the upper illuminator
246. ue to loss of database integrity Try a system default setting file The IV pole and AFI are both engaged Please confirm that the AFI bottle is at patient eye level The ultrasound module was not detected in the system Ultrasound and coagulation are not available The ultrasound module software version is not compatible with this software version Ultrasound and coagulation are not available The ultrasound module has failed to respond to a settings command The module settings have been re sent to the module The ultrasound module has reset The module settings have been re sent to the module The ultrasound handpiece is not connected or detected SG04 Call your product service representative if this problem persists SGO01 Call your product service representative SG02 Call your product service representative A compatible software version must be downloaded SG04 Call your product service representative if this problem persists SG04 Call your product service representative if this problem persists SG48 Please plug in the Phaco Frag ultrasound handpiece The ultrasound connector light is flashing SG49 If the handpiece is not detected unplug the handpiece and try another ultrasound handpiece SG04 Call your product service representative if this problem persists USMO6 Info The ultrasound handpiece has not been DM ipn Setup gt then select Prime tuned Tune or Tune Only
247. uilt into the system to provide filtered atmospheric air for anterior and posterior surgeries The front port provides air for both Fluid Air Exchange and Air Forced Infusion in posterior and 1 6 Operator s Manual 110017276EN Rev B 1 Getting Started ee combined surgery The port near the IV Pole on the back of the system provides air for Pressurized Infusion PI in anterior surgery The system can be set for either gravity infusion or infusion using pressurized air AFI and PI respectively through the Infusion Tab of the More Settings Screen or through the programming interface see Chapter 3 Both air output ports have lighted rings surrounding them The ring light will be solidly lit if that function is active and within correct pressure range If the pressure moves outside of the specified range the ring will begin blinking If the pressure remains outside the set range an error message will appear on the screen 1 4 Setting Up Your System Ad DANGER Do not use in the presence of flammable anaesthetics disinfectants aerosol sprays or in an oxygen rich atmosphere gt WARNING This system should only be operated by personnel who have been trained and are qualified to use this system gt WARNING Do not manually force the IV Pole downward if the system is on p WARNING Do not modify the pole height or manually force the pole height as this could cause an incorrect indication of the bottle height leadin
248. und Variable Power Linear Burst ultrasound 110017276EN Rev B Operator s Manual 8 15 8 Specifications Eo Ultrasound Mode Specifications Specification Maximum Power 35 Watts approx 900 ohms Frequency 28 5 kHz nominal Range 0 to 100 power in 1 increments Wave for Ultrasound Disabled Enabled throughout Control Linear power control via the footpedal Nominal phaco handpiece tip stroke at 100 power setting with DP8230 Microflow needle is 130 um at 28 5 kHz This results in a nominal peak tip velocity of 11 6 m sec Continuous Ultrasound Mode Maximum Power 35 Watts approx 900 ohms Frequency 28 5 kHz nominal Pulsed Ultrasound Mode Range 1 to 250 pulses per second Duty Cycle 5 to 95 in 1 increments Rise Time 1 or 2 Maximum Power 35 Watts approx 900 ohms Frequency 28 5 kHz nominal Range 80 to 600 msec burst width Control Single burst at end of pitch or yaw travel Single Burst Ultrasound Mode Maximum Power 35 Watts approx 900 ohms Frequency 28 5 kHz nominal Duration 2 to 600 msec Interval 2 to 600 msec Control Linear power control via the footpedal Burst duration and interval as selected Fixed Pulse Ultrasound Mode Maximum Power 35 Watts approx 900 ohms Frequency 28 5 kHz nominal Range 2 to 600 msec burst width Maximum Duty Cycle 50 to 99 in 1 increments Minimum Duty Cycle 1 50 in 1 increments Waveform Enabled Rise Time 2 Disabled Rise Time 1 Cont
249. use for another condition will be available for selection Voice Confirmation can also be enabled or disabled through this tab 2 28 Operator s Manual 110017276EN Rev B 2 User Interface ee The Display button control allows you to adjust the screen brightness change the display format level and select the system language as shown below Figure 2 32 A V More Settings Screen tab Display button 110017276EN Rev B Operator s Manual 2 29 2 User Interface The Video Overlay button allows you to select the language to be used for video overlays You can also set whether or not the system will combine Video Overlay Format information such as U S Averages settings and case information By default the U S data is shown as three separate lines on the video overlay If the U S combine option is set to Yes the display will appear on one line which will cycle through the three values Similarly settings are normally displayed on four lines and case information on two lines but if the combine option is set to Yes each will appear on one line that will cycle through the values Finally you can set the video overlay overscan in one degree increments from 0 to 5 Setting the overscan to 0 would maximize the display area of the display monitor Figure 2 33 A V More Settings Screen tab Video Overlay button 2 30 Operator s Manual 110017276EN Rev B 2 User Interface ESE Viscous Fluid Control More Setting
250. ut control is programmable from to 250 pulses per second in PPS increments The pulse rate control does not adjust the ultrasound power The control adjusts the number of cycles of ultrasound power that occur during a one second time interval In Pulsed Ultrasound Mode the ultrasound handpiece is energized for the portion of each time interval as programmed by the Duty Cycle setting Burst Mode Ultrasound Burst mode ultrasound is an anterior only mode to provide minimal ultrasound energy Ultrasound is applied in either single or multiple burst using a fixed power or in fixed burst using a linear control of power The burst duration can range from 2 to 600 msec When single burst mode is selected a burst of ultrasound energy is emitted when the Foot Control is pressed to 90 of the linear control position and is reset when the pedal is released to less than 90 of the linear control position TI 1 2 Figure 4 22 Burst Mode Ultrasound 1 Single Burst 2 Pedal Position 3 Power When fixed pulse mode is selected the pulse duration and interval may be selected with the screen settings 110017276EN Rev B Operator s Manual 4 33 4 Detailed Reference pp 2 gt Figure 4 23 Fixed Pulse Ultrasound 1 Fixed Pulse 2 Pedal Position 3 Power The ultrasound power is controlled by the linear control position of the footpedal When multiple burst mode is selected a sequence of bursts of ultrasound energy ar
251. utting is activated in Region 2 The cut rate is fixed Each successive outward yaw movement toggles the cutter ON or OFF If enabled an audible tone will indicate cutter on double beep or cutter off single beep For Dual Linear Cut mode outward yaw movement provides linear control of the cut rate as a function of footpedal displacement once it is within Region 2 The actual cut rate is displayed on the screen When the footpedal is released it returns to center and the cutter is disabled If enabled an audible linear tone indicates cut rate and the pitch of the tone increases with increased cutter speed Reflux if enabled is by inward yaw movement of the footpedal By default the vitrectomy cutter is On Pressurized Infusion Function gt WARNING This system is to be used in either air pressured infusion mode or IV Pole mode but never both together as high intraocular pressures may result x B Specific instruction for cleaning and sterilization included with the handpiece or accessory take precedence over these instructions X Note Once pressurized infusion pump is turned ON it will continue to operate even when the function is removed from the screen display E Note When using air pressured infusion hang the bottle so that the drip chamber is close to patient eye level 4 42 Operator s Manual 110017276EN Rev B 4 Detailed Reference The Pressurized Infusion function infuses a preset air pressure to
252. ve A compatible software version must be downloaded Foot Control detected on wired cable SG41 Please wait while the Foot Control WFCIO Info connection configuration completes Foot Control configuration on wired SG42 You may disconnect the Foot WFCII1 Info cable connection has completed Control cable and operate the Foot Control successfully wirelessly SG34 Replace the Foot Control with EbobConiral con auatonen tie wid another Foot Control using the wired cable WFCI2 Info cable connection TEE connection to the system SG04 Call your product service representative if this problem persists WFCI3 E Foot Control battery charge level is SE the wired cable connection to the SG43 Disconnect the Foot Control cable reconnect the cable and try again WFC14 Warning en e SG34 Replace the Foot Control with ST another Foot Control using the wired cable connection to the system SG34 Replace the Foot Control with The Foot Control spring has failed another Foot Control using the wired cable WFC16 Warning the Foot Control center pedal has been connection to the system disabled SG04 Call your product service representative if this problem persists The Foot Control battery has exceeded SG82 Immediately replace the battery to 300 charge cycles and the battery is ensure foot control functionality WFCI7 Warning nearly discharged The Foot Control may SG34 Replace the Foot Control with stop functioning unless the battery
253. vel Co Linear Cut For Co Linear Cut mode the footpedal pitch movement simultaneously controls linear vacuum and linear cut rate The downward pitch movement could be programmed to increment or decrement vacuum control Similarly the downward pitch movement could be programmed to increment or decrement cut rate control The range of vacuum level and cut rate is programmable Each successive outward yaw movement of the footpedal toggles the cutter ON or OFF By default the vitrectomy cutter is ON If enabled an audible tone will indicate vacuum level cut rate cutter on double beep or cutter off single beep Single Cut For Single Cut mode the footpedal pitch controls linear Vacuum Single cut will be activated when the footpedal move to 95 Release the footpedal back to at least 75 in order to have the subsequent single cut For all vitrectomy modes reflux if enabled is by inward yaw movement of the footpedal The foot control side button can also be programmed to activate reflux function e Note Make sure the pack you are using is appropriate for the domain selected Posterior Vitrectomy Setup and Use A Note Specific instructions for cleaning and sterilization included with the handpiece or accessory take precedence over these instructions WARNING For optimum aspiration and reflux performance the patient s eye level must be at the same level as no more than 7 cm 3 in from the Stellaris PC Vision Enhancement
254. ver the ultrasound needle so that the holes in the irrigation sleeve are placed approximately 1 mm from and perpendicular to the bevel of the ultrasound needle increase to approximately 1 5 mm for denser cataracts Le X Figure 4 25 Irrigation Sleeve 1 Irrigation Sleeve 2 Needle Ensure the irrigation clamp is open and toggle Irrigation Off to turn flow on and allow the flow to fill the irrigation tubing up to the handpieces See page 2 39 for details on the irrigation flow button activate the Fill button with turn flow on for 20 seconds Fill the test chamber with irrigating solution then slide over the tip of the handpiece Select Prime and Tune A vacuum test is part of the priming cycle After successful priming and tuning the Main Surgical Screen will appear The external components of your system are now ready Continue to set the operating parameters al Note 4 38 The system will not provide feedback as to whether or not fluid is present during priming Inspect tubing and confirm that it is filled with fluid and free of bubbles after each Prime and Tune Repeat the priming process if the tubing is not adequately filled with fluid Operator s Manual 110017276EN Rev B 4 Detailed Reference Phacoemulsification Use A CAUTION During any ultrasonic procedure metal particles may result from inadvertent touching of the ultrasonic tip with a second instrument Another potential source of metal particle
255. with that function will be removed or disabled Figure 2 48 Numeric Keypad Keyboard Sometimes you will need to enter alphabetical or numeric data into the Stellaris PC Vision Enhancement System A keyboard similar to that shown below will appear and you can touch the characters in order to enter them Selecting the back arrow will delete the last character typed and selecting Clear will delete all characters Select Enter when you are done to save the entry and return to the previous screen Figure 2 49 Keyboard 2 44 Operator s Manual 110017276EN Rev B 2 User Interface E Character Lengths When naming functions there is a limit to the number of characters that can be used That limit is the lesser of the number of characters in the table below or the number of characters displayable in the corresponding area on the screen Maximum Characters Pathology EE Display Format Selecting this button shown below steps that section of the display through multiple levels of complexity It appears on both the Status Bar Window and the Ultrasound Submode List c Figure 2 50 Display Format Selection Button 110017276EN Rev B Operator s Manual 2 45 2 User Interface Pop Up Message Window This type of window appears to display error and warning messages You should take the appropriate action before the system will continue Nothing else can be done on the screen while a pop up window is on the scree
256. y or S VIDEO IN connector of the MMC L A WARNING The surgical microscope camera must be medical grade SS Note The VIDEO IN connector requires that the camera output impedance be set to NORMAL or 75 OHMS if the camera has a switch setting or adjustment for output impedance 3 Using the video output cable E provided with the MMC connect the COMPOSITE VIDEO OUT or S VIDEO OUT from the MMC L to the user supplied video monitor H If desired the video cassette recorder G per manufacturer s instructions for that equipment may be connected between the MMC and monitor using user supplied cables Use the included RCA Jack to BNC Plug adapter if necessary The video monitor must be connected to the MMC before the MMC is powered up If the MMC is powered up with no monitor or recorder connected the video output with the overlay may not appear The MMC must be powered down and powered up again with the monitor connected A Note The COMPOSITE VIDEO OUT output must be used if the input video signal is connected via the COMPOSITE VIDEO IN connector The S VIDEO OUT output must be used if the input video signal is connected via the S VIDEO IN connector WARNING The VCR and or Monitor connected to the MMC must be medical grade or plugged into a medical grade isolation transformer 4 Attach the Ethernet cable on the back of the Stellaris PC Vision Enhancement System Computer Unit J Attach the other end of the data communicati
257. y by selecting Shut Down from the end of case screen or pressing and holding the front button for at least 8 seconds ensuring the IV pole is fully retracted Remove any objects from mat on top of unit Depressurize the compressed air supply that feeds your unit Disconnect the pneumatic air hose from the lower left corner facing the rear end of the unit Store the tray all the way in the unit s tray receptacle Fully close the front drawer Roll the power cord in its proper hooks at the rear end of the unit Place the foot control on its dedicated hook at the rear end of unit Remove the bottles and tube sets from the unit s pole hanger and store separately from the unit Make sure no objects such as air hose electrical cord video cables etc lie in the moving path Disengage the front brake lever Always maneuver the unit using the handle bar designed for this purpose Do not store anything on top of the system and do not pull the system by the IV pole 1 30 Operator s Manual 110017276EN Rev B 1 Getting Started Ee 1 11 System Components The Stellaris PC Vision Enhancement System has an advanced modular design with independent modules concealed in a uniquely designed exterior housing The top level of the system is the user interface screen and computer unit The surgical modules are concealed inside the main housing and strategically positioned to provide optimum user interaction and surgical functions The

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