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1. A WARNING gt WARNING gt WARNING gt WARNING gt WARNING gt 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 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 Patient not to come in contact with earthing metal parts Avoid skin to skin contact Grounding reliability can only be achieved when the equipment is connected to an equivalent receptacle marked Hospital Only or Hospital Grade To avoid risk of electric shock this equipment must only be connected to a supply mains with protective earth 110017243EN Rev H Operator s Manual 1 1 1 Getting Started 1 1 System Description The Stellaris Vision Enhancement System has a modular design which enables it to be upgraded to take advantage of advances in technology The system consists of a main housing unit which contains a user inte
2. Programming Level 2 Disabled Enabled Technique Customize Fluidics Settings by Pathology Programming Level 2 Disabled Enabled Technique Customize Ultrasound Settings by Needle Tip Programming Level 2 Disabled Enabled Technique Customize Ultrasound Settings by Cataract Grade Programming Level 2 Disabled Enabled Technique Customize Ultrasound Settings by Pathology Programming Level 2 Typewriter data entry 20 characters max Technique Pathology Name Phase Name Typewriter data entry 8 characters max Mode Type Ultrasound Irrigation Aspiration Irrigation Coagulation Phase Pneumatic Vitrectomy Electric Vitrectomy Mode Icon All icons for the given mode type Ultrasound Submode Typewriter data entry 20 characters max Name 3 26 Operator s Manual 110017243EN Rev H 3 Customizing Your System Foot Control SESS i Options Ranges Sizes ae Mode change control Not While Active Allow Limit Pedal Allow Remap Surgeon Pedal and 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 R2 start to 5 lt R3 start by 5 Region 3 5 gt R2 start to 95 by 5 Group toe heel Left side Group Ungroup Technique switches Right side Group Ungroup Dual Linear Enable Programming Level 1 Technique Disabled not displayed not programmable Programming Level 2 Level 3 Disabled Enabled Linear
3. 1 2 1 22 SENS Up YOUESYSEeIE uon geed dee Rei Biegen 1 3 1 3 Moving Your System to Another Location a EEE nee nennen 1 11 LA System Components isese seen ae een na 1 12 2 User Interface 2 1 Basic Interface Controls og ee 2 1 2 2 Surgical More Screens anne BER ee ak 2 6 2 3 DULSICAal Screen EE 2 14 ZA E ee 2 18 3 Customizing Your System SEM CUPIDE tious 3 3 Side System Setup c one reto a D pe die E ERO OR He oven MER PI E it E CO ies 3 18 3 9 System CODIIBUFALIOR 5 o Sont e om neta tue ed ve E ne e erret ioris 3 21 34 System Calendar orte oreet ei bed tace e e SE 3 22 3 9 Lrubink e 3 23 3 6 Customization Levels ree e ee vr ENSE ENEE esse 3 25 4 Detailed Reference 4l Computer Unit ar EE 4 1 4 2 System Console iot ti etude dete irte ne e apvd rete i cei creates 4 2 ABs VN Pole Em 4 5 4 4 Remote Comttoll seen naar ana 4 6 45 Advanced Vacuum System Elutdics u 2 se een 4 7 4 6 Advanced Flow System Fluidics aeneae tette ie eir ern 4 12 4 7 lrngation Aspiration Setup ceteri sun an aan essen 4 14 4 8 Vitrectomy Punction skolou Gon neo gus ceo e e Ca E OC HQ ERE I pd HEEL EE Cree eee ird edges dog 4 15 4 9 Ultrasound Function ie eti Eed 4 20 4 107 SEET EE 4 27 4 11 DigiFlow Pressurized Infusion Function 4 30 110017243EN Rev H Table of Contents FF 5 5 1 3 2 5 3 5 4
4. 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 detail instructions to detach tubing manifold from the cassette SG29 Call your product service representative if the cassette is not full and this problem persists SG34 Replace the Foot Control with another Foot Control using the wired cable connection to the system SG35 Call your product service representative 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 SG38 Reposition the Foot Control and ensure that the center pedal and buttons are not activated SG39 Position the Foot Control on a flat working surface Initiate wireless foot control connectivity by pressing one of the Foot Control buttons momentarily the left LED will light up SG45 Check that there are no leaks in the air line and that the air line tubing is connected tightly to the other pack components SG46 Turn the pressurized infusion pump off wait for a few seconds and then turn the pump back on SG47 Confirm correct operation of the aspiration function SG48 Please plug in the ultrasound handpiece The ultrasound connector light is fla
5. 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 8 4 Operator s Manual 110017243EN Rev H Brazil BL Industria Otica LTDA Rua Dona Alzira 139 91110 010 Porto Alegre RS Brazil Tel 55 51 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 Canada Bausch amp Lomb Canada 520 Applewood Crescent Vaughan Ontario L4K 4B4 Canada Tel 905 695 7695 Fax 905 695 7656 Tel 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 110017243EN Rev H 8 Service and Warranty EH Operator s Manual 8 5 8 Service and Warranty EH 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
6. O Operation Aspiration 4 7 Capsule Polish 4 8 4 12 Computer Unit 4 1 Control Numeric Keypad 2 3 Pop Up Window 2 5 Progress Bar 2 3 Test Tube Control 2 2 Foot Control See Also Foot Control Operation Irrigation 4 7 Phacoemulsification Burst 4 20 Linear 4 22 Pulse 4 20 Turning on System 1 4 Viscoelastic Removal 4 8 4 13 Vitrectomy Cutter Modes 4 16 General 4 14 Yaw Aspiration 4 23 Option List 2 2 P PD Pulse Duration 4 20 Phaco Phacoemulsification cation 4 20 PI Pulse Interval 4 20 Pneumatic Vitrectomy Cutter 4 15 PPS Pulses Per Second 2 8 2 16 4 20 Pressurized Infusion 2 7 2 15 3 8 3 28 4 30 4 32 7 18 Pulse Duration PD 4 20 Pulse Interval PI 4 20 Pulse Mode Ultrasound 4 20 Pulses Per Second PPS 2 8 2 16 4 20 Push Bar 2 1 110017243EN Rev H Index Index R Reflux 2 29 2 33 4 8 4 12 4 13 4 18 4 19 Remote Control Description 4 6 Specifications 9 10 Remote Control Batteries 4 6 Remote Control Tab 2 13 Replacement Fuse 7 1 Restore Preference File 3 16 Rise Time U S 9 14 9 15 S Screen Display Tab 2 12 Screen Layout 2 14 Settings Managing 3 3 Settings More 2 8 2 13 Setup Coagulation Fixed 4 28 Linear 4 29 Phacoemulsification 4 24 Setup MMC 6 3 Specifications Advanced Flow 9 16 Cables 9 4 Coagulation 9 12 Computer Unit 9 8 EMI 9 4 Environmental 9 1 9 2 Foot Control 9 9 High Speed Vitrectomy 9 15 I A Vitrectomy 9 15 IV Pole 9 11 MMC 9 2
7. 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 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 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 st
8. Physical 9 2 Remote Control 9 10 Ultrasound 9 13 Vacuum Fluidics 9 15 Spin Button 2 1 Sterilization Bipolar Accessories 5 3 I A Handpiece 5 7 Phacoemulsification Handpiece 5 12 Phacoemulsification Needle 5 12 Surgeon Preference File Create 3 14 System Settings 2 6 110017243EN Rev H T Tabbed Screen 2 7 Technical Assistance 8 2 Test Tube Control 2 2 Time Format 3 18 Time Setting 3 18 Transducer Cleaning 5 4 Troubleshooting 7 1 Trulink amp Remote Access 1 16 TruLink amp Remote Access 3 23 U Ultrasound Handpiece Cleaning For U K 5 14 Phacoemulsification 5 8 Sterilization Phacoemulsification 5 12 Module Specifications 9 14 Needle Cleaning 5 11 Sterilization 5 12 Operation Burst 4 20 4 22 Linear 4 22 Pulse 4 20 Phacoemulsification Module Description 1 15 Specifications 9 13 Operation Burst 4 20 4 22 Linear 4 22 Pulse 4 20 Power 4 20 Ultrasound More Settings 2 8 Ultrasound U S See Also U S Unpacking 6 2 Unplanned Vitrectomy Setup Vacuum Fluidics 4 18 U S Ultrasound 1 15 110017243EN Rev H Index Index V Vacuum Fluidics Function 4 7 Vacuum Fluidics Unplanned Vitrectomy Setup 4 18 Vacuum Fluidics Vitrectomy 4 14 Vacuum Limit Settings 2 16 Vacuum Response 4 8 4 13 Venting 4 8 4 12 Video Overlay Tab 2 12 Viscoelastic Removal Operation 4 8 4 13 Vitrectomy Cutter High Speed Electric 4 14 Vitrectomy Cutter Pneumatic 4 15 Vitrectomy More 2 9 Voice Confirmation 2 11 W W
9. RESPONSIBILITY FOR ANY INCIDENTAL CONSEQUENTIAL SPECIAL OR EXEMPLARY DAMAGES OR EXPENSES ARISING OUT OF THE PURCHASE OR USE OF THE Stellaris 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 amp Vision Enhancement System OR THIS WARRANTY WHETHER IN CONTRACT TORT STRICT LIABILITY OR OTHERWISE SHALL NOT EXCEED THE PURCHASE PRICE OF THE Stellaris 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 minimum period of six 6 months from the date of delivery unless otherwise specified on your sales 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 fo
10. Single Burst Ultrasound Frequency 28 5 kHz nominal Mode Range 80 to 600 msec burst width Control Single burst at end of pitch or yaw travel Maximum Power 35 Watts approx 900 ohms Frequency 28 5 kHz nominal Fixed Pulse Ultrasound Duration 2 to 600 msec Mode Interval 2 to 600 msec Control Linear power control via the footpedal Burst duration and interval as selected Maximum Power 35 Watts approx 900 ohms Frequency 28 5 kHz nominal Range 2 to 600 msec burst width Multiple Burst Duty Cycle 50 to 99 in 1 increments Ultrasound Mode Rise Time 1 or 2 Control 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 9 14 Operator s Manual 110017243EN Rev H 9 Specifications Vacuum Fluidics Function Specifications Specification Provides Cassette Full Near Full and Continuous Fluid General Level Sensing Programmable Rise time curves Modes of Linear control of vacuum Aspiration Operation Fixed On Off control of vacuum Dual Linear Modes Pitch or Yaw I A mode 0 mmHg to 600 mmHg Operating Phaco 10 mmHg to 600 mmHg Parameters Vitrectomy 0 mmHg to 600 mmHg Vacuum Control mmHg increments ES Gravity feed from I V bottle with pinch valve On Off control Irrigation via footpedal Gravity feed or Pressurized Infusion from the Balanced Salt Solution bottle Vie Control Modes Continuous Activated via the F
11. and when fluid venting is selected it is vented to a positive pressure equal to the bottle height head pressure 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 and is generated in the Advanced Vacuum system by irrigation pressure The Stellaris Vision Enhancement System s Advanced Vacuum system is designed for use with continuous reflux but for any surgical mode reflux may be programmed to be either continuous or off none If enabled the reflux feature is activated by inward movement of the footpedal in all aspiration modes 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 much longer The response can be changed through the programming interface see Chapter 3 or the Fluidics More Screen see page 2 7 The Stellaris Vision Enhancement System Advanced Vacuum System has five levels of vacuum response setting with one being fastest response and five being slowest response 4 8 Operator s Manual 110017243EN Rev H 4 Detailed Reference Foot Control of Irrigation Aspiration As the footpedal is initially pressed
12. by 5 Surgeon brightness System master audio 0 to 100 by 5 Surgeon volume Tone selection and Irrigation No tone Tone 1 Tone 10 0 to 100 by 5 Surgeon volume control Vacuum No tone Tone 1 Tone 10 0 to 100 by 5 U S No tone Tone 1 Tone 10 0 to 10096 by 5 Bipolar Tone 1 Tone 10 2096 to 10096 by 596 Vit No tone Tone 1 Tone 10 0 to 100 by 5 Occlusion 096 to 10096 by 596 Error 2096 to 10096 by 596 Voice confirmation Enabled Disabled Surgeon Volume 046 to 10096 by 596 Video overlay English Surgeon language Video overlay display Combine case information lines No Yes Surgeon format Combine ultrasound averages lines No Yes Combine settings lines No Yes Video overlay 096 to 596 by 196 Surgeon overscan allowance Technique Name Typewriter Data Entry 20 characters max Surgical Mode Format 1 Format 2 Technique Display Format Status Bar Display Format 1 Format 2 Format 3 Technique Format 110017243EN Rev H Operator s Manual 3 25 3 Customizing Your System BM Case Customization Levels Options Ranges Step Sizes Esc Programming Level Level 1 Level 2 Level 3 Programming Level 2 Disabled Enabled Technique Customize Settings by Phase Case Programming Level 2 Disabled Enabled Technique Customize Fluidics Settings by Needle Tip Programming Level 2 Disabled Enabled Technique Customize Fluidics Settings by Cataract Grade
13. lec LES recom 55 n gp ms Far ux ANY AC Electrical oD Power Source Optional Connection Video Camera Without Recording Device Not Supplied Not Supplied H l Video Recorder L Not Supplied Connect the detachable power cord B to the MMC and plug it in to the AC power source WARNING Do not plug the MMC into multiple portable socket outlets or extension cords 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 necessary or S VIDEO IN connector of the MMC L WARNING The surgical microscope camera must be medical grade 110017243EN Rev H 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 Operator s Manual 6 5 6 Setup e LLLI 4 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 ap
14. 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 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 A WARNING Improper reassembly of tubing manifold to the cassette may result in inadequate system performance Instructions To Empty Cassette The Stellaris Vision Enhancement System s Advanced Vacuum Fluidics cassette can be emptied during operation with following instructions 1 Stop operation and protects handpiece with test chamber Close irrigation clamp Select Setup from surgical screen to transition to Setup screen Select Eject Cassette from the setup screen Remove cassette from the system gx pu d e d Detach the aspiration tubing that connects to the cassette Hold aspiration tubing very close to the connector to facilitate removal Pink arrows 110017243EN Rev H Operator s Manual 4
15. 110017243EN Rev H 2 User Interface T Progress Bar This graphic shows the progress of a procedure 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 with that function will be removed or disabled Min 110017243EN Rev H Operator s Manual 2 3 2 User Interface Keyboard Sometimes you will need to enter alphabetical or numeric data into the Stellaris 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 or it will advance to next level of programming screen Character Lengths There is a finite number of characters that can be used for certain functions Refer to the table below Function Maximum Characters NEN Display Format Selecting this button shown below steps that section of the display through multiple levels of complexity It appears on the Status Bar Window and the Ultrasound Submode List e 2 4 Operator s Manual 110017243EN Rev H 2 User I
16. 2 3 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 ultrasound irrigation aspiration Phases can be added deleted or re ordered They may also be customized as described below Exceptions Tab Each technique may include up to four exceptions Exceptions can be added deleted or re ordered They may also be customized as described below Foot Control Tab Group or ungroup Foot Control Buttons enable disable next ultrasound modulation on yaw reflux type none or continuous Fluidics Tab Aspiration types Vac Vac Modes Flow Vac Modes Flow Flow Modes Flow All modes IV Pole Height Vacuum Response Venting Method Air or Fluid Irrigation Shut Off Delay ms Pressurized Infusion Function enabled disabled Pressurized Infusion Pump on off and Pressurized Infusion Settings mmHg A V Tab Display Format 1 or 2 Status Bar Format 1 2 3 3 6 Operator s Manual 110017243EN Rev H 3 Customizing Your System LSS 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 Select Customize and more options specific to that function will appear and can be modified These can include Phase Information Foot Control settings Fluidics Aspiration and Infusion Ultrasound Ultrasound and Wave Form
17. 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 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 Flow The lower left corner of the screen shows the maximum flow setting if enabled with the current actual flow value below it The volume of fluid in the collection device is also displayed here 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 and the circles around the top indicate yaw position The Footpedal More Button brings up a More Screen that allows you to change settings on the footpedal
18. Accessories A WARNING The coagulation accessories should not be sterilized using a cold soaking solution A WARNING 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 CAUTION All bipolar accessories must be rated for an operating voltage of at least 120V 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 sterilized as follows Standard Gravity
19. 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 800 cuts per minute in 30 cuts per minute increments utilizing the up down spin buttons or one cut per minute increments utilizing the numeric keypad Dual Linear Cut Pneumatic cutter The control may be adjusted to provide a linear cutting speed from 30 to 800 cuts per minute in 30 cuts per minute increments utilizing the up down spin buttons or one cut per minute increments utilizing the numeric keypad A WARNING Never intentionally modify handpieces or tips such as do not bend cut or engrave as they could break or malfunction 4 16 Operator s Manual 110017243EN Rev H 4 Detailed Reference Planned Vitrectomy Setup A WARNING For optimum aspiration and reflux performance the patient s eye level must be at the A Note same level as no more than 7 cm 3 in from the Stellaris 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 Turn Power on Press any button on the Foot Control and wait until the ready light turns solid green indicating wireless communication has been established Select Surgeon s Name and select Confirm Ope
20. Battery Compartment Door The Foot Control does not automatically transition 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 E Symptom Potential Cause Corrective Action Foot Control lost Pitch control of Region 2 3 and Yaw Pitch could only control Irrigation On Off The four side buttons function normally 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 Operator s Manual 7 17 7 Troubleshooting and Maintenance Symptom Potential Cause Corrective Action No or low infusion with 1 Air tubing or irrigation tubing may be Check air tubing and Pressurized Infusion kinked irrigation tubing for kink function or pinch 2 The air tubing pathway may be o
21. GmbH Brunsbiitteler Damm 165 173 13581 Berlin Tel 49 6221 823184 Fax 49 6221 823149 Hotline within Germany 0800 2233331 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 8 6 Operator s Manual 110017243EN Rev H 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 Pasubio 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 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 Samseong clong Gangnam gu Seoul Korea Tel 822 558 2988 Fax 822 642 1586 110017243EN Rev H 8 Service and Warranty EH Operator s Manual 8 7 8 Service and Warranty e Ue Malaysia Bausch amp Lomb Malaysia S
22. Linear Yaw Control below Set and programmed for a right or left footed operator with the home position in the center giving approximately 10 of motion in both directions 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 E g If 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 diagram below Pedal Offset Switch Indicator Pedeal Offset Position Pedeal Offset Position Pedeal Offset Position Left Center Right for system setup for system setup for system setup for left foot operation for left or right foot for right foot operation 2 32 Operator s Manual 110017243EN Rev H 2 User Interface zz u Single Linear Setup In Vitrectomy Mode the outward yaw movement provides ON OFF cutting control Each successive outward movement toggles the programmed tool ON 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 f
23. Main Programming Screen and a new screen will appear through which you can monitor and initiate remote service on your system Exit Programming gt V up F rogramming TruLink Remote Access 110017243EN Rev H Operator s Manual 3 23 3 Customizing Your System Select TruLink amp Remote Access and ensure that the Ethernet cable is connected to the Stellaris Vision Enhancement System and to the designated hospital network port e Note If you have the optional MMC system the Ethernet cable should be connected to the MMC then the MMC connected to the hospital Ethernet port Ext PORTET TruLink Remote Access STELLARIS TRULINK Confirm that the system is not being used for surgery The system will then be controlled by the remote technician When the remote technician is finished your Stellaris Vision Enhancement System will be shut down You may then restart the system A Note Off the shelf Ethernet cable may be used with the Stellaris Vision Enhancement System to establish or restore connections 3 24 Operator s Manual 110017243EN Rev H 3 Customizing Your System nn 3 6 Customization Levels The following tables detail which options can be customized at which levels Audio Visual Customization Level Options Ranges Step Sizes Typewriter data entry 30 characters max Screen voice English Surgeon language Display backlight 20 to 100
24. Select Setup select Open Drawer and make sure that the flow fluidics module and cartridge vacuum sensor surfaces are clean and dry Select Close Drawer to retry the cartridge vacuum sensor test SG20 Select Setup and select Prime and Tune or Prime Only to complete the system priming Check irrigation and aspiration tubing connections for leaks Check that the test chamber is forming a tight seal around the handpiece Try priming the system again g SG24 Select Open Drawer load a new pack and try priming the system again SG25 Confirm correct irrigation and aspiration function 110017243EN Rev H Operator s Manual 7 13 7 Troubleshooting and Maintenance Suggestion Suggested Action Text Arrange the soonest convenient time to empty the cassette To empty cassette and reprime 1 Clamp irrigation line 2 Select the Setup icon 3 Select Eject Cassette button 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 detail instructions to detach tubing manifold from the cassette Call your product service representative if the cassette is not nearly full and this message persists Empty the cassette To empty cassette and reprime 1 Clamp irrigation line 2 Select the Setup icon 3 Select Eject Cassette button
25. Specifications Computer Unit Specifications Specification 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 Display Assembly Swivel 90 left and 90 right Brightness Controlled via touch screen Display Technology Resistive Analog Size Approximately 19 diagonal active area Touch Screen Environmental Chemical resistant to cleaning solutions Drip proof bezel Motherboard Technology IBM Compatible Pentium or better Computer hardware Hard Drive or Solid State Drive Computer Assembly Two Audio Speakers Two USB ports Ethernet port 9 8 Operator s Manual 110017243EN Rev H 9 Specifications Da r Mp Ht Foot Control Specifications Specification External components and housing are corrosion resistant Watertight housing Wireless control 10m standard range Corded low voltage connection to system General Non skid base 4 gray colored function switches Wall Charger 3 6v battery lithium Battery charging cradle 12 22 em 4 8125 in H 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 Left On Off simulated Right On Off simulated Left Linear Right Linear Increase decrease Function switches On Off Function Motion Pitch up down Automatic return to up position Center pedal Pitch Detent 2 programmable as to position may
26. 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 110017243EN Rev H Operator s Manual 5 3 5 Cleaning and Sterilization Requirements 5 3 Advanced Flow Fluidics Transducer The transducer should be cleaned on a weekly basis Refer to figure for the following instructions Transducer The Stellaris amp Vision Enhancement System must be in an Advanced Flow System operating mode Open the drawer by pressing the Open Drawer button Use an absorbent sponge SuperSorb sponge moistened with isopropyl alcohol to remove contaminant or saline from the transducer surfaces shown D Use a dry absorbent sponge to remove moisture from the transducer surfaces A Note Transducer must be thoroughly dry before using this function 5 4 Operator s Manual 110017243EN Rev H 5 Cleaning and Sterilization Requirements 5 4 Irrigation and Irrigation Aspiration Handpieces A CAUTION Use only warm 30 C to 40 C or 85 F to 105 F distilled or d
27. The system has lost communication with the Foot Control wireless SG84 disabled SG85 110017243EN Rev H Operator s Manual 7 11 7 Troubleshooting and Maintenance Lem A Text Message Suggested Action s The system has lost communication with the Foot Control SG83 SG34 SG04 Foot Control Receiver Module Messages Text Message Suggested Action s WFROI The Foot Control receiver was not detected in the system Surgical mode SGO1 is not available WFR02 The Foot Control receiver software version is not compatible with this SG02 software version Surgical mode is not available WFRO3 The Foot Control receiver has failed to respond to a settings command SG04 The module settings have been re sent to the module WFRO4 The Foot Control receiver has reset The module settings have been SG04 re sent to the module Internal Application Messages 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 7 12 Operator s Manual 110017243EN Rev H 7 Troubleshooting and Maintenance EH Suggested Actions for Messages Suggestion Suggested Action Text Action ID SGO1 Call your product service representative S
28. Vision Enhancement System s Phacoemulsification Handpiece as indicated above 5 7 Cleaning the MMC A CAUTION To preserve the chassis finish avoid the use of abrasive cleaners If possible clean spots before they dry 5 14 Operator s Manual 110017243EN Rev H 5 Cleaning and Sterilization Requirements zu SSS AN 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 110017243EN Rev H Operator s Manual 5 15 5 16 Operator s Manual 110017243EN Rev H 6 Setup Setup This chapter provides information for setting up your Stellaris Vision Enhancement System and making necessary connections E DANGER Do not use in the presence of flammable anaesthetics disinfectants aerosol sprays or in an oxygen rich atmosphere WAR
29. Vitrectomy Coagulation settings When you are done making changes select Exit Programming The system will ask you to confirm your changes before exiting 110017243EN Rev H Operator s Manual 3 9 3 Customizing Your System Customize Foot Control To modify the techniques for the Foot Control select the Foot Control Tab on the Surgeon Programming Level Screen You can set the Foot Control to use right or left foot operation The Mode Change Control allows you to set the Stellaris Vision Enhancement System response when the footpedal is activated and you change surgical modes The Detent Control determines what feedback the Stellaris Vision Enhancement System will give when changing footpedal regions Use the Region Spin Control Buttons to change the percent depression at which each region begins uc ER ee IX Vacuum Module Leve 3 10 Operator s Manual 110017243EN Rev H 3 Customizing Your System Customize Fluidics To set the parameters for Fluidics functions select the Fluidics Tab on the Surgeon Programming Level Screen You can set the BSS Balanced Salt Solution Bottle Type Patient Eye Level relative to the aspiration port on the fluidics system Ultrasound Needle Type I A Tip Type and Electric Vit Tip Type by selecting the current setting You can select the new setting from the drop down menu that appears 110017243EN Rev H Operator s Manual 3 11 3 Custom
30. a procedure or overflow may occur The system will then advance to the End of Case screen lower the IV Pole and eject the vacuum fluidics cassette or open the flow module drawer 1 10 Operator s Manual 110017243EN Rev H 1 Getting Started E Date 4 Mar 2006 Time 01 01 01 Surgery Summary pr verage ime Dr Smith Start Of Case 04 01 04 Wee merit Seca Flow 42 mimis 00 00 00 Divide amp Conquer End Ot Setup 01 01 04 us ox 0 00 00 x NU OLOR DUE Prwomatic Vit 230cpm 00 00 00 Electric Vit 1250cpm 00 00 00 Flow 2 ER Total Time 01 01 01 Cong 16 00 00 00 Grade 1 Any Pathology Case Time 01 01 01 Flutd Level 125mi AVE 0 U S APT 0 00 00 EPT 0 00 00 Message Log m USMO1 The anterior module was not we detected in the system Ultrasound Bausch amp Lomb coagulation and electric vitrectomy functions are not available mRERICTE Pizpossuien Remove the fluidics collection device Remove all disposables from the system For assistance 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 or press the button on the front of the system to completely power down the system A CAUTION Never turn the power switch off or disconnect the power without proper system shutdown Equipment damage can
31. 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 S3 OV Si dme De e Remove the bottles and tube sets from the unit s pole hanger and store separately from the unit 8 Make sure no objects such as air hose electrical cord video cables etc lie in the moving path 9 Disengage the front brake lever 10 Always maneuver the unit using the handle bar designed for this purpose Your system is now ready to be moved to a new location A Note Do not store anything on top of the system and do not pull the system by the IV pole 1 12 Operator s Manual 110017243EN Rev H 1 Getting Started 1 4 System Components The Stellaris amp Vision Enhancement System has a modular design which enables it to be 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 handpieces and other accessories A WARNING Use only handpieces cables 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
32. and Warranty n M FA 8 16 Operator s Manual 110017243EN Rev H 9 Specifications Da D MU mp Specifications 9 1 Environmental and Physical Specifications e Note This device contains items which may be classified as waste electrical or electronic equipment Please dispose of the equipment according to local requirements 110017243EN Rev H Operator s Manual 9 1 9 Specifications 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 5mm x 20mm 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 MMC Optional Accessory 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 amp Vision 122 cm H x 45 7 cm W x 45 7 cm D Enhancement System 48 in H x 18 in W x 18 in D excluding IV Pole and 162 5 cm 64 in from floor to top of I
33. 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 system 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 3 20 Operator s Manual 110017243EN Rev H 3 Customizing Your System ru ee 3 3 System Configuration To see a detailed listing of the software and hardware configuration of your system select System Configuration from the Main Programming Screen E EE Een E e oo _ a ee Im E Te Tg oe ooo a LL LLL ZA LLLLLLGLLLGGUIG QG u GLLLGLDGRReV LOAGGLZGa G LLLGAGOGGmue OLILEI LLALIIIBL nn Jr M COO OOOOOOQOmm rE ss eS 10010 LU LU Te ZT Tg E EH 110017243EN Rev H Operator s Manual 3 21 3 Customizing Your System 3 4 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 Manapa Settings System Calendar f lt gt Ca Ta Lu o The second column next to the listing of the days of the week determines if the default surgeon applies to
34. 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 4 5 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 Balanced Salt Solution drip chamber This is an equivalent pressure not Intraocular Pressure of 22 4 mm Hg The IV Pole can extend to 140cm 55 in an equivalent pressure of 102 74 mmHg To change the programmed bottle height settings for the current surgical mode select the Fluidics More Screen See page 2 7 then select the Infusion Tab to change the actual height preset height or the maximum height the IV Pole is allowed to reach The maximum IV Pole height should be set when installing the Stellaris Vision Enhancement System in a particular medical facility You can do this using the programming interface see Chapter 3 110017243EN Rev H Operator s Manual 4 5 4 Detailed Reference 4 4 Remote Control A CAUTION The remote control is not waterproof and is not sterilizable The remote control must be p
35. 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 the irrigation and aspiration tubing to the appropriate phaco or vitrectomy handpiece and plug the handpiece into the Stellaris Vision Enhancement System The connector will flash until the handpiece is connected and then will remain solidly lit Attach the ultrasound handpiece needle Attach the irrigation sleeve Fill beaker and test chamber and attach the test chamber to the handpiece The irrigation pinch valve shall be opened when this step is displayed For detailed instructions select Show Me Steps Ultrasound or Show Me Steps Vitrectomy and a tabbed screen will appear detailing the required steps and showing animations of how to perform each step A WARNING The animations illustrate the steps but do not represent sterile technique 110017243EN Rev H Operator s Manual 1 9 1 Getting Started 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 When the fluidics collection device has been attached and all accessories tubing and handpieces have been connected the system will automatically advance to the Prime and Tune
36. handle The system sits on four rotating casters The front two wheels can be locked in place by pressing down on the wheel brake lever with your foot Pulling up on the wheel brake releases the lock 4 2 Operator s Manual 110017243EN Rev H 4 Detailed Reference Main Power Switch Ethernet Port Power Cord Retention Clip Power Cord Input Foot Control Backup Cable Port On the lower back of the system console are the ON OFF power switch power cord port Ethernet port and Foot Control cable port 110017243EN Rev H Operator s Manual 4 3 4 Detailed Reference IV Pole User Interface Screen System Switch ON OFF Pneumatic Anterior Vit Acuator Handpiece Connectors Expansion Space Fluidic Module Surgical Tray One Touch Wheel Locking 4 4 Operator s Manual 110017243EN Rev H 4 Detailed Reference 4 3 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 CAUTION Do not manually force the IV Pole or use the IV Pole as a handle The Stellaris amp 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 through any of several methods It can be controlled through the touch screen Foot Control if programmed remote control or directly by using the buttons on the back of the system
37. if needed After a successful test select Advance to Surgery and select the Vit phase from the clock menu 4 18 Operator s Manual 110017243EN Rev H 4 Detailed Reference Foot Control of Vitrectomy Mode In the anterior mode irrigation is supported by a single gravity fed irrigation system or Pressurized Infusion in which the irrigation tubing is routed through a pinch valve 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 cutting 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 cu
38. in and hold until it is automatically captured by the system The cassette housing backlight will stop blinking and turn solid when the system captures the cassette For surgical techniques that uses high vacuum settings please use vacuum based packs containing the StableChamber tubing to increase holdability higher vacuum levels while maintaining followability controlled flow e Ifusing a flow system insert the Fluidics Cartridge and select Close Drawer 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 1 8 Operator s Manual 110017243EN Rev H Note 1 Getting Started Connect the accessories to the system for either an ultrasound or vitrectomy procedure The steps needed to setup for a surgical procedure are Spike Bottle Connect Tubing Plug in Handpiece Attach Needle Attach Sleeve and Fill Test Chamber as detailed below If a linear coagulation in setup is enabled or a Foot Control button is programmed for coagulation begin by plugging in the coagulation cord Spike the Balanced Salt Solution bottle and hang it at the desired bottle height Additional step if pressurized infusion is used Connect the Air Tubing Line D4600A to the vent port at the bottle spike and the other end with air filter to the Stellaris amp air output connector Switch on the air pump
39. 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 Use a Select Vit from the clock menu The Show Me Steps animated setup guide will appear 110017243EN Rev H Operator s Manual 4 17 4 Detailed Reference b C 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 yaw the footpedal inward Unplanned Vitrectomy Setup In the event anterior vitrectomy is needed during phaco surgery a Select the Vitrectomy mode from the clock menu The Show Me Steps animated setup guide will appear Select Close to close the animated setup guide Open vitrectomy cutter pack Connect aspiration tubing and the actuation line to the pneumatic port on the Stellaris amp 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
40. or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the Stellaris Vision Enhancement System requires continued operation during power mains interruptions it is recommended that the Stellaris 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 IEC 61000 4 8 Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment IEC 60601 test level Compliance level Electromagnetic environment guidance 110017243EN Rev H Operator s Manual 9 5 9 Specifications e Guidance and Manufacturer s declaration electromagnetic immunity Portable and mobile RF communications IEC 61000 4 6 150 kHz to 80 MHz equipment should be used no closer to any part of the Stellaris Vision Enhancement System including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended Separation distance d VP Conducted d VP 80 Mhz to 800 MHz Radiated d VP 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
41. status to the surgical team It is displayed by selecting the Footpedal More Button which is the below the Footpedal status icon on the bottom of the Main Surgical Screen 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 2 33 When released the footpedal will return to the home up or center position The table on page 2 34 shows the possible combinations of control available The programmable detents provide tactile feedback to the pitch movement when it moves between different regions 2 30 Operator s Manual 110017243EN Rev H 2 User Interface E 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 An example of single region pitch control is the linear coagulation function Two Region Pitch Control There are two programmable regions two dete
42. the full day or if separate defaults will be applied to the morning and afternoon of that weekday Select P X or to 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 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 selection which room number this Stellaris amp Vision Enhancement System is located These settings determine how the case numbers will be incremented to avoid duplicate case numbers for a single surgeon 3 22 Operator s Manual 110017243EN Rev H 3 Customizing Your System rS i 3 5 TruLink Remote Access A WARNING You must contact your local Bausch Lomb sales and support office before activating the TruLink Remote Access function See Technical Assistance on page 8 2 for the sales and support office that serves your location WARNING Do not conduct surgery or any patient procedures while TruLink Remote Access 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 TruLink Remote Access from the
43. the same level as no more than 7 cm 3 in from the Stellaris Vision Enhancement System aspiration port Failure to follow this procedure may result in serious and permanent patient injury Note Do not use StellarisPC Vision Enhancement System posterior or combined packs on a Stellaris system e Note Specific instructions for cleaning and sterilization included with the handpiece or accessory take precedence over these instructions Note The ultrasound handpiece needle and irrigation sleeve must be sterilized before performing these steps a Turn Power on 4 24 Operator s Manual 110017243EN Rev H 4 Detailed Reference b Press any button on the Foot Control and wait until the right light turns solid green indicting wireless communication has been established c Select Surgeon s Name and select Confirm d Open disposables pack and insert fluid collection system fusing a vacuum system 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 turn solid when the system captures the cassette e fusing a flow system insert the fluidics cartridge and select Close Drawer System will start cassette vacuum test or cartridge calibration automatically e After vacuum test or cartridge calibration completes the Setup Screen will appear with Prime and Tune as the highlighted function f Spike the Balanced Salt Solu
44. 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 User Interface Screen The User Interface Screen is the way the user communicates with the Vision Enhancement System See page 2 1 for details Technical specifications can be found in Chapter 9 system wee 5f Cmos IV Pole AN E cm fus aveo APT 0 00 00 EPT 0 00 00 2 Pet i 7 140 Open Pack 2 en P 4 rogramming A d Advance To Select Si b Surgery e Surgeon A e Prime and L I ub Select Tune Room Open Pack Select Insert Cassette Case DEE A om soos o Cassette Vacuum Test 110017243EN Rev H Operator s Manual 1 13 1 Getting Started Stellaris amp Vision Enhancement System Console IV Pole User Interface Screen System Switch ON OFF Handpiece Connectors s Surgical Tray M Pneumatic Anterior Vit Acuator Expansion Space Fluidic Module One Touch Wheel Locking This is the main unit see page 4 2 which contains the connections for all handpieces tray drawer Ethernet connector and system hou
45. 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 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 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 Repeat Step 9 at least three times 5 10 Operator s Manual 110017243EN Rev H 5 Cleaning and Sterilization Requirements i 3 i Handpiece _ Fluid Pathway P4 Syringe Stopcock Needle Cleaning Instructions For reusable 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 5 B 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 110017243EN Rev H Operator s Manual 5 11 5 Cleaning and Sterilization Requirements Phacoemulsification Handpiece and Accessories Sterilization A WARNING Before each use the handpiece and power cord should be inspected for damage nicks c
46. 1 9 Specifications Coagulation Function Specifications Specification Single Floating BF Connection Connector Coaxial connector Coagulation A Connections United States Banana Jack Cord Banana Jack to Coaxial Cords adapter International Reusable Coaxial Cord Modes of Operation Linear Mode Fixed Mode Output Range 7 5 Watts Nominal 100 ohms Frequency 1 MHz nominal Linear Mode Maximum Peak Open Circuit Voltage 120V Range Programmable from 0 to 100 in 1 increments Operating Control Linear control of coagulation power via the footpedal Parameters Output Range 7 5 Watts Nominal 100 ohms Frequency 1 MHz nominal Fixed Control Maximum Peak Open Circuit Voltage 120V Range Programmable from 0 to 100 in 1 increments Control On Off control via the footpedal Settings 100 ege 2 4 54B a gt P ta nn SEU SS 7590 a e us load A Hen 100 y iu 1 Saa eo Bipolar Power vs Load 2 no Power watts X 100 200 300 400 500 600 700 800 900 1000 Load ohms Maximum Possible Peak Coagulation Output Voltage at all Output Control Settings and Both Modes linear and Fixed Control Peak Output v 80 1 100 Output Control Setting 90 9 12 Operator s Manual 110017243EN Rev H 9 Specifications Deae j Ultrasound Function Specifications Specification Special Features Ultrasound Time System records and displays ultr
47. 10017243EN Rev H 3 Customizing Your System ru en ee rg Customizing Your System This chapter explains how to customize your Stellaris 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 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 through the Programming interface You can create modify and backup surgeon setting preference files as well as modify system parameters The programming screens are organized as outlined in the diagrams below Programming Manage Settings System Setup System System TruLink Configuration Calendar Remote Access Customize E gn Restore Delete Date Time System ID Rooms e Technique Foot Control Fluidics Exceptions Surgeon Profile d N Technique Foot Control Fluidics Audio Visual Profile Phase Foot Control Fluidics Case Ultrasound Vitrectomy Coagulation Profile Case Settings Settings Aspiration Infusion Ultrasound Ultrasound Settings Settings Settings Waveform Settings 110017243EN Rev H Operator s Manual 3 1 3 Customizing Your System E T
48. 2 5 5 6 2 7 6 6 1 6 2 6 3 7 7 1 1 2 7 3 7 4 7 5 8 8 1 8 2 8 3 9 9 92 Cleaning and Sterilization Requirements Stellaris Vision Enhancement System Routine Cleaning Bipolar Coagulation Accessories esses Advanced Flow Fluidics Transducer eee Irrigation and Irrigation Aspiration Handpieces esses Phacoemulsification Handpiece and Accessories esses Special Instructions for United Kingdom Users see Cleaning the LEE Setup Setup Be Connections RTE conteret o Gre bert ira eren operata Multimedia Center MMC optional accessory esee Troubleshooting and Maintenance User Troubleshooting 502 56 ntn emite e a Power E Informational and Warning Messages e Troubleshooting the MM n itinere erepto nennen System Configurations Modules Accessories and Packs Service and Warranty Kee en rer EE Environmental Brotecton cesses Warranty Information 5 5 er rr ee Specifications Environmental and Physical Specifications eese Primary System Specifications esere ise iea aie E 110017243EN Rev H 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 manual
49. 24 Assistance 8 2 Audio Tab 2 11 AVE Average Ultrasound Power 4 20 Average Ultrasound Power AVE 4 20 A V More Screen 2 11 B Backup 3 15 Batteries Remote Control 4 6 Burst U S 4 20 4 23 Button Spin 2 1 C Calibration U S 4 24 Capsule Polish Operation 4 8 4 12 Cassette Full 4 7 Cassette Nearing Full 4 7 Cleaning Handpiece Bipolar Accessories 5 3 For U K 5 14 Irrigation Aspiration 5 5 Phacoemulsification 5 8 Needle Ultrasound 5 11 Transducer 5 4 Clock Menu 2 14 110017243EN Rev H Index Index o o Coag Display 2 16 Coag Spin Control 2 16 Coagulation Accessories Cleaning 5 3 Setup Fixed 4 28 Linear 4 29 Function Description 1 15 Specifications 9 12 Coagulation More 2 9 Computer Unit Operation 4 1 Specifications 9 8 Connections Electrical 6 2 Customize Exception 3 8 D Date Format 3 18 Date Setting 3 18 DC Duty Cycle 2 8 2 16 4 20 Delete Settings File 3 17 Description Function 1 15 IV Pole 4 5 System 1 2 1 12 Display Level 1 2 14 Display Level 2 2 17 Disposables Setup and Use Coagulation Fixed 4 28 Linear 4 29 Dual Linear Control 2 29 Duty Cycle 2 8 2 16 4 20 110017243EN Rev H E Effective Phaco Time EPT 4 20 Enterprise Server 1 10 Environmental Protection 8 12 Equipment Classifications 9 3 Error Messages 7 3 Ethernet Cable 1 4 Exception Customizing 3 8 Exceptions 2 14 F Flow Status 2 16 Fluidics More Settings 2 7 Fluidics Vacuum 4 7 Foot Control
50. 4 208 781 0000 Fax 44 208 781 0001 Europe Middle East amp African Division European Headquarters Vietnam c o address is Singapore see Singapore 110017243EN Rev H Operator s Manual 8 11 8 Service and Warranty 8 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 disposal of standard electronic components and equipment 8 12 Operator s Manual 110017243EN Rev H 8 Service and Warranty PH ri 8 3 Warranty Information Stellaris amp Vision Enhancement System Warranty Bausch amp Lomb Incorporated warrants for the benefit of the purchaser only that the Stellaris 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 accor
51. 6 3 Battery Charging 2 27 Description 1 15 2 18 Functions 2 29 Linear Control 2 33 Operation Aspiration 4 9 Irrigation 4 9 Ultrasound 4 20 Vitrectomy 4 19 Specifications 9 9 Footpedal 2 30 Footpedal More 2 10 2 30 Footpedal Status 2 16 Fuse Replacement 7 1 H Handpiece Cleaning Bipolar Accessories 5 3 For U K 5 14 Irrigation Aspiration 5 5 Phacoemulsification 5 8 Sterilization Bipolar Accessories 5 3 For U K 5 14 Irrigation Aspiration 5 7 Phacoemulsification 5 12 Height IV Pole 2 7 High Speed Electric Vitrectomy Cutter 4 14 110017243EN Rev H Index Index I VA Handpiece Cleaning 5 5 Sterilization 5 7 Irrigation Handpiece Cleaning 5 5 Sterilization 5 7 Operation 4 7 IV Pole 2 15 Description 4 5 Specifications 9 11 IV Pole Height 2 15 3 28 K Keyboard 2 4 L Language 2 12 3 5 3 13 3 18 Layout Screen 2 14 Level 1 Display 2 14 Level 2 Display 2 17 M Maximum IV Pole Height 3 28 4 5 Menu Clock 2 14 MMC MultiMedia Center 1 17 Module Coagulation See Also Coagulation Module Computer Unit See Also Computer Unit IV Pole See Also IV Pole Ultrasound See Also Ultrasound Module More Coagulation 2 9 More Footpedal 2 10 More Screen A V 2 11 More Screens 2 6 More Settings Fluidics 2 7 More Settings Ultrasound 2 8 More Vitrectomy 2 9 MultiMedia Center 1 17 Multimedia Center MMC setup 6 3 110017243EN Rev H N Needle Cleaning 5 11 Sterilization 5 12
52. 9 4 Detailed Reference 7 Press manifold to release latch to free it from the cassette Pink arrows 8 Drain fluid out of the cassette 10 Press the manifold to engage manifold latch 4 10 Operator s Manual 110017243EN Rev H 4 Detailed Reference 11 Connect aspiration tubing to the cassette connector 12 Insert cassette to the system 13 Release irrigation clamp 14 Select Prime Only on the Setup screen to re prime the cassette before use 110017243EN Rev H Operator s Manual 4 11 4 Detailed Reference 4 6 Advanced Flow 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 Vision Enhancement System aspiration port Failure to follow this procedure may result in serious and permanent patient injury WARNING Ensure the maximum capacity of the fluid collection device is not exceeded as this could cause a hazardous situation to the patient The Stellaris Vision Enhancement System s Advanced Flow system consists of a retractable cartridge drawer a vacuum transducer system a drive motor control solenoids and electronics The Advanced Flow System cartridge is manually loaded and sits tightly in the drawer slot Select Close Drawer to engage the device Irrigation Aspiration Mode Irrigation With your Stellaris Vision Enhancement System s Advanced Flow system the
53. BauschaLomb Stellaris Vision Enhancement System mmm Operator s Manual Es 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 priorwritten consent of Bausch amp Lomb Incorporated Rochester NY 14609 USA are trademarks of Bausch amp Lomb Incorporated orits affiliates Allotherbrand productnames are trademarks of their respective owners Manufacturing site Bausch amp Lomb Incorporated I One Bausch amp Lomb Place EC REP Bausch amp Lomb Incorporated d Bausch amp Lomb Incorporated ONLY Rochester NY 14609 USA 106 London Road Kingston upon Thames KT2 6TN UK 1 215 3365 Tree Court Industrial Blvd St Louis MO 63122 110017243EN Rev H BL3153EN Preface Indications for Use The Bausch Lomb Stellaris Vision Enhancement System is designed for use in anterior segment surgeries It provides capabilities for phacoemulsification irrigation aspiration bipolar coagulation and vitrectomy 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 meant for the system are connected User Profile The Bausch Lomb Stellaris Vision Enhancement System is intended for use only by qualified physicians and
54. Coagulation in Disabled Enabled Technique Setup Mode Grouped switch Unassigned Mode U S Submode Vacuum Flow Bottle assignment Height U S Power U S PPS Duration U S DC Interval Coag Power Vit Cut Rate Ungrouped switch Unassigned Next Phase Previous Phase Next U S assignment Submode Confirm Settings Irr On Off Continuous Reflux Vit On Off Fixed Coag Vacuum Fluidics None Continuous Technique AFS Fluidics None Single Repeat Continuous Phase Next Ultrasound Disabled Enabled Modulation on Yaw Note that for single linear foot pedal modes the outward yaw motion would be used for next ultrasound modulation and for dual linear foot pedal modes the inward yaw motion would be used Fixed Coagulation 096 to 1096 by 196 Power Level 1096 to 3096 by 296 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 Programming Level 3 Dual Linear Flow only for AFS fluidics if flow modes enabled Vit Modes Disabled Asp on Pitch Programming Level 3 Asp on Yaw Programming Level 3 Dual Linear Flow only for AFS fluidics if flow modes enabled Irr Mode Coag Modes Disabled not displayed 110017243EN Rev H Operator s Manual 3 27 3 Customizing Your System Fluidics Parameter Options Ranges Step Sizes x Max bottl
55. G02 Call your product service representative A compatible software version must be downloaded SOU Confirm correct irrigation aspiration and vitrectomy function SG04 Call your product service representative if this problem persists SG05 Call your product service representative to replace the vacuum fluidics module SG06 Call your product service representative to replace or calibrate the vacuum fluidics module SG07 Call your product service representative to replace the flow fluidics module Call your product service representative to replace or calibrate the flow fluidics module Open the flow fluidics module drawer re insert the cartridge and close the drawer again Try to observe if the pump head moves as the drawer closes Call your product service representative to replace the flow fluidics module if this problem persists the cassette vacuum check Select Setup select Open Drawer re insert the flow fluidics cartridge and select Close Drawer for the cartridge vacuum sensor test SG14 Please wait for the flow fluidics module cartridge vacuum sensor check to complete SGI5 Replace the vacuum fluidics cassette SG16 Select Setup select Open Drawer re insert the flow fluidics cartridge and select Close Drawer for the cartridge vacuum sensor test SGI7 Make sure that the flow fluidics module and cartridge vacuum sensor surfaces are clean and dry SG18 Replace the flow fluidics cartridge SG19
56. H 2 User Interface Fluidics Flow and Vacuum More Screen The Fluidics More Screen has two tabs one for Aspiration settings and one for Infusion settings Select either tab at the top of the Fluidics More Screen to see options specific to the fluidics system installed on your system The specific options available will depend on what accessories you have on your system the current programming level and other system settings The Aspiration Tab can show the current mode vacuum settings flow settings vacuum response setting venting method and Foot Control Mapping The Infusion Tab can show the current Infusion mode IV Pole Height actual preset and maximum Balanced Salt Solution Container Type Patient Eye Level Irrigation Delay and Pressurized Infusion enabled disabled pressure settings pump on off status The actual IV Pole height is the current distance between the aspiration port and the mid point of the viewing port of the Balanced Salt Solution 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 and set at time of system installation A zero level bottle hanger BL4363 is an optional accessory that allows the Balanced Salt Solution drip chamber to be level with the aspiration port 110017243EN Rev H Operator s Manual 2 7 2 User Interface Ultrasound More Settings The Ultrasound More Screen shows the current modulat
57. NING 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 110017243EN Rev H Operator s Manual 6 1 6 Setup 6 1 Setup Instructions 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 6 2 Connections and Setup The Stellaris amp Vision Enhancement System is pre configured at the factory to minimize setup and installation requirements The following information explains the connections for the Foot Control power cable and MMC optional Power Cable a Connect the power cable at the bottom rear of the system Main P Switch Fuse holder SRE OWE Whe Ethernet Port Power Cord Retention Clip Power Cord Input Foot Control Backup Cable Port 6 2 Operator s Manual 110017243EN Rev H 6 Setup Ethernet Cable Connect the Ethernet cable from the back of the Stellaris 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 t
58. See page 2 10 for details on changing these settings See note on page 2 33 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 current case number Selecting the Display Format Button see page 2 4 repeatedly shows progressively more detail 2 16 Operator s Manual 110017243EN Rev H 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 slider ring on the tube can be used to change the setting 110017243EN Rev H Operator s Manual 2 17 2 User Interface 2 4 Foot Control The Foot Control is the main interface between the surgeon and the Stellaris 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 Cables are not in use make sure to
59. Specifications ZZ M Recommended separation distances between portable and mobile RF communications equipment and the Stellaris Vision Enhancement System The Stellaris 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 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 KHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz transmitter W d Xp d XP d XP 100 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 transmitter manufacturer Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 110017243EN Rev H Operator s Manual 9 7 9 Specifications 9 2 Primary System
60. Supply as it only sustains the software but is not sufficient to power surgical functions If the user of the Stellaris Vision Enhancement System requires continued operation during power main interruptions it is recommended that the Stellaris Vision Enhancement System be powered from an uninterruptible power supply All new Stellaris systems and Power modules manufactured after November 2009 will cease to have memory back up battery function ea Note In the event the power source is interrupted causing the system to shut down remove handpiece from the eye safely and pinch off irrigation clamp to stop fluid flowing into the cassette To Start a New Procedure A Note Ensure tube set connection is secure when connecting to the handpiece and system The Stellaris amp Vision Enhancement System is user friendly and will highlight whichever step is next in a typical procedure The steps 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 110017243EN Rev H Operator s Manual 1 7 1 Getting Started A Note Ensure sufficient volume of irrigation solution is available for the procedure The level should be monitored during the procedure Setup Fluid Collection System Open disposables pack and connect fluid collection system e Ifusing a vacuum system insert the fluidics cassette all the way
61. Surgical mode is not available VFMO3 The vacuum fluidics module has failed to respond to a settings command SG03 The module settings have been re sent to the module SG04 VFM04 The vacuum fluidics module has reset The module settings have been SG03 re sent to the module SG04 VFMO5 The vacuum fluidics module does not have valid factory calibration data SG05 Surgical mode with the vacuum fluidics module is not available SG06 VFMO6 The vacuum fluidics module cassette vacuum check has not been SGI1 attempted VFMO07 The vacuum fluidics module cassette vacuum check is in progress SG13 VFMO8 The vacuum fluidics module cassette vacuum check has failed SG11 SG15 SG04 VFMO09 System priming has not been attempted SG20 VFM10 System priming is in progress SG21 VFM11 System priming has failed SG22 SG23 SG04 VFM13 The vacuum fluidics module cassette is nearly full SG26 SG27 VFM14 The vacuum fluidics cassette is full SG28 SG29 The vacuum fluidics module vitrectomy cutter output pressure is low SG30 Vitrectomy cutter may not be cutting SG31 SG04 VFMI7 Insert the vacuum fluidics cassette SG79 7 10 Operator s Manual 110017243EN Rev H 7 Troubleshooting and Maintenance Foot Control Module Messages Text Message Suggested Action s WFCO1 The Foot Control battery has exceeded 300 charge cycles SG32 The Foot Control battery may not provide power for the entire day SG33 SG34 WFCO02 The Foot Control does not have valid f
62. Upon removal battery must be charged before it s stored Use only Bausch Lomb supplied wall chargers BL4391 charging cradles BL4393 adapters BL4A392US BL4392UK BL4392EU BL4392AUS BL4392ROW and batteries BL4390 with the Stellaris 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 Note Note 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 switch is turned ON This charging method applies with or without the Graphical User Interface being turned ON 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 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 When the Foot Control is connected to the wall charger it will not communicate with the system and cannot be used in surgery To connect backup cable or wall charger to Foot Control align red dot of the conn
63. V Pole handle Approximate Weight 230 pounds 114 kg Recommended tray capacity 12 pounds 5 4 kg 9 2 Operator s Manual 110017243EN Rev H 9 Specifications Duae Ju Standards Compliance The Stellaris 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 Mode of Operation Electromagnetic Compatibility EMC The Stellaris 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 Vision Enhancement System Guidance on maintaining appropriate separation between communications equipment and the Stellaris Vision Enhancement System is provided in the tables below A complete line of accessories for the Stellaris 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
64. actory calibration data Surgical SG34 mode is not available SG35 WFCO3 The Foot Control is programmed for right footed operation but is set up SG36 for left footed operation WFCO4 The Foot Control is programmed for left footed operation but is set up for SG36 right footed operation SG37 WFCO5 The Foot Control center pedal or button sensors have failed or the Foot SG38 Control has been activated continuously since being powered on SG34 n Q LA SQ SG04 WFCOS System not detecting the Foot Control SG40 SG33 WFC09 The Foot Control software version is not compatible with this software SG34 version Surgical mode is not available WFC10 Foot Control detected on wired cable connection SG41 WFCII Foot Control configuration on wired cable connection has completed SG42 successfully WFC12 Foot Control configuration on the wired cable connection has failed SG34 SG04 WFC13 The Foot Control battery charge level is low SG33 WFC14 The Foot Control battery is nearly discharged SG43 SG34 WFC15 The wireless Foot Control signal quality is poor WFC16 The Foot Control spring has failed the Foot Control center pedal has been SG34 disabled SG04 WFC17 The Foot Control battery has exceeded 300 charge cycles and the battery SG82 is nearly discharged The Foot Control may stop functioning unless the SG34 n n Q Q w D gt battery is replaced immediately WFC18 System not detecting the Foot Control SG33 SG34 WFC19
65. ancement System in a typical cataract surgery This information is intended for use by someone who is already familiar with this type of system 110017243EN Rev H Operator s Manual 1 3 1 Getting Started Surgical Drape Setup Attach the sterile screen drape by placing the drape over the top of the Stellaris Vision Enhancement System screen and secure with the adhesive strip to top not the front of the display as shown in the illustration below Apply Screen Drape Here Tray Drape Turning System On Plug the power supply cord into the wall If desired connect the Ethernet cable to the port at the bottom of the Stellaris 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 Turn on the switch at the bottom of the system console A CAUTION Do not turn this switch off until the system has been properly powered down A CAUTION Do not disconnect system from power while in use 1 4 Operator s Manual 110017243EN Rev H 1 Getting Started 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 Not
66. anufacturer s declaration electromagnetic immunity The Stellaris 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 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 411 6 kV contact 8 kV air 2 kV for power supply lines 1KV for input output lines 1kVdifferential mode 2 kV common mode 5 U 95 dip in U for 0 5 cycle 40 U 6096 dip in U for 5 cycles 70 U 30 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 1kV 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 3096 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial
67. arranty Information 8 13 Y Yaw Aspiration 2 33 110017243EN Rev H Getting Started User Interface Customizing Your System Detailed Reference Cleaning Sterilization Setup Troubleshooting Maintenance Service and Warranty Specifications payers Duap anpuatut Jos ula js s Jno Bulziwo sn 22U9J9J23 paliejag uonezi uojs Duuean dnyas e ueuajurey Bunoousoe qnoJ Ayuessem pue 3911135 suonerijinads
68. art 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 110017243EN Rev H Operator s Manual 4 23 4 Detailed Reference 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 irrigation 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 Never intentionally modify handpieces or tips such as do not bend cut or engrave as they could break or malfunction gt WARNING Do not touch an activated ultrasonic handpiece tip as injuries could occur gt 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 gt WARNING For optimum aspiration and reflux performance the patient s eye level must be at
69. asound time in 0 01 second increments Tuning System provides one step tuning Self adjusts to resonant frequency of handpiece Probe Present System provides a probe present detection system Wave form ultrasound available Type Floating BF Connection Modes of Operation 110017243EN Rev H Programming Levels 1 2 3 Continuous ultrasound Pulsed ultrasound Fixed pulse ultrasound Single burst ultrasound Multiple burst ultrasound 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 ultrasound Variable Power Linear Burst ultrasound Operator s Manual 9 13 9 Specifications E Ultrasound Function Specifications Operating Specification Parameter Maximum Power 35 Watts approx 900 ohms Frequency 28 5 kHz nominal Range 0 to 100 power in 1 increments Continuous Ultrasound Wave for Ultrasound Disabled Enabled throughout Mode Control Linear power control via the footpedal Nominal phaco handpiece tip stroke at 100 power setting with DP8130 Microflow needle is 130 um at 28 5 kHz This results in a nominal peak tip velocity of 11 6 m sec 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 or 2 Maximum Power 35 Watts approx 900 ohms
70. astic removal function provides different settings for the doctor s convenience These settings may be customized to allow quick entry into a higher vacuum limit level as explained in Chapter 3 Venting The Advanced 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 vacuum build up 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 Reflux Aspiration is applied via the Advanced Flow Pump and subsequently to the surgeon s handpiece via a tube set Reflux applies a momentary pressure through the aspiration line to clear the aspiration port of lodged material An additional reflux option is continuous reflux used to ease needle insertion through the incision The reflux feature is applied with the inward rotation of the footpedal in all aspiration modes Yaw inward the footpedal initiates the reflux cycle releasing it completes the cycle Subsequent reflux cycles may be applied with repeated footpedal operations Single reflux is limited Forward revolutions of the pump are required before reflux may be actuated 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
71. be enabled or disabled Control Provides primary linear function or on off 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 Physical Center pedal Yaw Center Pedal Yaw Motion Momentary Push button Function switches Control Provides programmable increment decrement or on off control of assigned function 110017243EN Rev H Operator s Manual 9 9 9 Specifications Remote Control Unit Specifications Parameter Specification using an IR transmitter yd Vacuum Level Increase Decrease Aspiration ASP Flow Rate Increase Decrease Up Phase Increment Decrement shared button Parameter increment Future Use decrement Ultrasound Power U S Vitrectomy Coagulation 9 10 Operator s Manual 110017243EN Rev H 9 Specifications E 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 Operation aspiration port Parameters 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 110017243EN Rev H Operator s Manual 9 1
72. bleshooting and Maintenance p Ha cat 7 3 Informational and Warning Messages All messages displayed by the user interface are uniform in their appearance However the box will have a red border 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 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 Prefs TWoubeArea APM MMC USM VEM WEC WER 110017243EN Rev H Operator s Manual 7 3 7 Troubleshooting and Maintenance E Flow Fluidics Module Messages i Action s AFMOI The flow fluidics module was not detected in the system Surgical mode with the flow fluidics module is not available AFMO2 The flow fluidics module software version is not compatible with this software version Surgical mode is not available The flow fluidics module has failed to respond to a settings command The module settings have been re sent to the module SG04 The flow fluidics module has reset The module settings have been re sent to the module SG04 The flow fluidics module does not have valid factory calibration data Surgical mode with the flow fluidics module is not available SG08 The fluidics pump motor may have failed SG10 The flow fluidics module cartridge vac
73. bstructed Ensure new air tubing is System displays actual used Otherwise replace pressure correctly and air is with new tubing coming out of the air output z P 5 Preset pressure may be set too low Increase air pressure connector setting to desired level If problem persists with the all of the above corrective actions stop using Pressurized Infusion and call service 5 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 Close irrigation clamp to stop fluid flow into the cassette cartridge and handpiece Replace test chamber to the handpiece that is connected to the tubing 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 Reset the device by working with good or new inputs removing the batteries and batteries waiting for at least one minute before re installing the batteries 7 18 Operator s Manual 110017243EN Rev H 7 Troubleshooting and Maintenance Heu MH eee 7 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 re
74. buttons may be assigned to advance to the next submode when ungrouped e 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 installed before using Select Prime and Tune on the Setup Screen 110017243EN Rev H Operator s Manual 4 21 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 resi
75. creen first then insert device 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 amp Vision Enhancement System Operations with other USB devices are NOT supported 110017243EN Rev H Operator s Manual 3 15 3 Customizing Your System Restore a Settings File To restore an existing surgeon preference file from a USB memory device 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 Must select the screen first then insert device System will only recognize USB device after this screen is selected Select the Restore Tab from the Manage Settings Screen 3 16 Operator s Manual 110017243EN Rev H 3 Customizing Your System E Delete a Settings File To delete an existing surgeon preference file make sure the Delete Tab is active at the top of the Manage Settings Screen select the file or files to be deleted and select Confirm TM 2 onc s 110017243EN Rev H Operator s Manual 3 17 3 Customizing Your System 3 2 System Setup Select System Setup from the Main Programming Screen and a new screen will a
76. d individual only E Note Other than main fuses 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 User Troubleshooting fthe aspiration line becomes clogged and it cannot be cleared using reflux remove the handpiece from the eye and clear the aspiration port of lodged material e If 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 Global Product Support see Chapter 8 7 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 or 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 Fuse Replacement The Stellaris Vision Enhancement System has 2 user replaceable fuses If a
77. d 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 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 50cc ml mark 2 Connect the end of the syringe to the infusion line on the phaco handpiece 3 Pushon 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 4 Repeat Steps 1 through 3 at least three times 5 Hill the syringe with air reattach to infusion line and push on the syringe plunger to force air through the handpiece Disconnect the syringe 6 Repeat Step 5 at least three times 110017243EN Rev H Operator s Manual 5 9 5 Cleaning and Sterilization Requirements EEE TE re Syringe D Flush the aspiration lumen as follows see figure below 1 Dio Qv wr de SS 10 From the rear of the handpiece insert aspiration brush provided in the CX7120 Universal Maintenance Kit into the aspiration fitting Push the brush bristles through the handpiece aspiration lumen then pull the brush back out 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 50cc ml mark
78. dance 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 warranty 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 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
79. 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 Vision Enhancement System has been altered neglected abused or misused e the Stellaris amp 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 Vision Enhancement System or its components occurring subsequent to delivery or g the non conformity or defect is not reported 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 Vision Enhancement System 110017243EN Rev H Operator s Manual 8 13 8 Service and Warranty el BAUSCH LOMB EXCLUDES AND DISCLAIMS ALL OTHER WARRANTIES OR REPRESENTATIONS RELATING TO THE Stellaris 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
80. ding essential information Consult operating instructions Caution or warning to consult accompanying documents to avoid patient or operator hazard 110017243EN Rev H Preface 3 Preface Direct Current 7 1 Remote Control Reception Indicator Foot Control On TruLink Access Equipotential Ground Dispose of Properly Serial Number Authorized Representative in the European Community Do H 7 Frequency in Hertz Non Ionizing Electromagnetic Radiation Oe er Camera Recorder Ethernet Ex Monitor i Stellaris Vision Enhancement System Qo coh Preface 4 SPEER 1 A COAG Or COAG 2 VIT Or VIT u s OF U S Q VA A Alternating Current Foot Control Battery Battery Condition Indicator Manufacturer Date of Manufacture Caution Consult Accompanying Documents Type BF Applied Part Coagulation Pneumatic Vitrectomy Ultrasound Ohms Volt Amps Amperes 110017243EN Rev H Preface 2 CFR 801 109 b FR ONLY Caution Federal US law restricts this device to sale by or on the order of a physician No Latex Member Green Dot Scheme Do Not Use if Package is Damaged System transport information refer to page 1 12 Gees Caution Consult Accompanying Documents 1 110017243EN Rev H Preface 5 Preface Preface 6 110017243EN Rev H Table of Contents 1 Getting Started 1 1 System Description
81. dn 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 8871 Mexico Bausch amp Lomb Mexico S A 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 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 6 8 Operator s Manual 110017243EN Rev H Portugal Bausch amp Lomb S A Sucursal Portugal 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 151 Lorong Chuan 04 03A New Tech Park Lobby C Singapore 556741 Tel 65 68349112 Fax 65 62860448 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 Va
82. ds on bottle height The preset air pressure may be adjusted from the system screen display Pressurized Infusion is an optional function of Stellaris 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 A zero level bottle hanger BL4363 is an optional accessory that allows the Balanced Salt Solution drip chamber to be level with the aspiration port 110017243EN Rev H Operator s Manual 4 31 4 Detailed Reference 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 1 2 3 Select Infusion Tab of the pop up screen 4 Select Pressurized Infusion to Enabled See diagram below Pressurized Infusion Enabled Disabled Infusion Pump On Off 5 Selecting Infusion Pump to On will automatically activate the air pump whenever the surgeon file is selected for surgery 6 Pressurized Infusion settings and function could be saved with Case More Screen 4 32 Operator s Manual 110017243EN Rev H 4 Detailed Reference Pressurized Infusion Setup 1 Remove the filter cap A from the bott
83. dures in continuous pulsed and burst modes Coagulation The third port is for a coagulation handpiece which provides coagulation power in either Fixed or Linear modes See page 4 27 for details of use and page 9 12 for technical specifications 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 Specifications are in Chapter 9 See page 2 18 for detailed instructions for its use Fluidics Function Each Stellaris amp Vision Enhancement System has one fluidics module either an Advanced Flow or Advanced Vacuum system Each fluidics module contains a port for a standard pneumatic vitrectomy cutter Advanced Flow Function This function uses a peristaltic based pump to provide flow from 1 ml min to 60 ml min and vacuum levels from 0 to 650 mmHg The corresponding pack has both irrigation and aspiration tubing and a 500 ml fluid collection bag which fits in a drawer on the front of the Stellaris Vision Enhancement System Irrigation on off control is provided by an internal pinch valve Pneumatic vitrectomy supports both a Linear Cut Rate and a Fixed Cut Rate from 30 to 800 cpm See page 4 12 for details and Chapter 9 for technical specifications Advanced Vacuum Function This function uses a vacuum based pump to control the output vac
84. e Turning off the Main Power Switch will disconnect the system from mains 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 amp 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 110017243EN Rev H Operator s Manual 1 5 1 Getting Started A 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 Only after the Foot Control has been synchronized to the specific Stellaris Vision Enhancement System see page 6 3 may you use wireless communication e 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 Chapter 3 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 ligh
85. e Case Region 2 minimum 20 mmHg to 200 mmHg by 5 mmHg vacuum for aspiration 200 mmHg to 600 mmHg by 10 mmHg control feature vacuum modes 110017243EN Rev H Operator s Manual 3 29 3 Customizing Your System zZ Options Ranges Step Sizes y Programming Level 2 Linear flow minimum level for flow modes Programming Level 2 Region 2 minimum flow for aspiration control feature flow modes with control on flow Programming Level 2 Linear vacuum limit minimum level for flow modes Programming Level 2 Region 2 minimum vacuum limit for aspiration control feature flow modes with control on vacuum limit Programming Level 2 Foot control mapping for linear control Programming Level 3 Pitch function for dual linear flow aspiration modes Programming Level 3 Foot control mapping for yaw function linear control in dual linear aspiration flow modes 0 ml min to 10 ml min by 1 ml min 10 ml min to 30 ml min by 2 ml min 30 ml min to 60 ml min by 5 ml min Minimum of 5 ml min for U S modes 0 ml min to 10 ml min by 1 ml min 10 ml min to 30 ml min by 2 ml min 30 ml min to 60 ml min by 5 ml min 0 mmHg to 20 mmHg by 1 mmHg 20 mmHg to 200 mmHg by 5 mmHg 200 mmHg to 650 mmHg by 10 mmHg Minimum of 10 mmHg for U S modes 0 mmHg to 20 mmHg by 1 mmHg 20 mmHg to 200 mmHg by 5 mmHg 200 mmHg to 650 mmHg by 10 mmHg Linear Front Loaded Back Loaded Vacuum limit Flow Linear Front Loaded Back Loaded 3 30 Operato
86. e function will deactivate Fixed coagulation mode is accessible during the system setup e If programmed a tone will signify bipolar coagulation operation 110017243EN Rev H Operator s Manual 4 29 4 Detailed Reference Linear Coagulation Setup and Use gt WARNING Assure the handpiece and accessories are sterilized before use as specified x 58 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 X Note Due to compliance with IEC 60601 2 2 position 1 will not start until approximately 3596 of pedal travel is attained in the linear coagulation mode B Adapter EZ e Et Se E 2 Pin Connector Style SCT Em mj Lemo Connector a Connect the desired bipolar forceps or pencil to its cable The use of an adapter may be necessary b Connect the bipolar cable to the coagulation electrical connector if required c Select Coag from the clock menu d Use the spin buttons to adjust the Max Coagulation power desired e Thelinear coagulation function is actuated by the footpedal if programmed The Actual Coagulation prog
87. e height 30 to 140 cm by 5 cm Balanced Salt 500 ml Bottle 500 ml Bag 250 ml Bottle Surgeon Solution Container Type Default Ultrasound Standard MicroFlow MicroFlow Thin Tip Coaxial Tip Type MICS Stable Flow 20 Gauge Stable Flow 19 Gauge Tip Type Electric Fluidics Types VFM Vac Modes AFM Vac Modes AFM Flow Modes AFM All Modes Phase Case Irrigation Delay 100 to 3000 ms steps of 50 milliseconds Also resolution of 50 ms even with calculator Phase Case Vacuum Response 1 Fastest 2 3 4 5 Slowest Technique Phase Case Programming Level 2 Fluid Venting Air Venting Technique Vent Method Phase Case Pressurized Infusion Disabled Enabled Technique Displayed Pressurized Infusion On Off Technique Pump Pressurized Infusion 0 mmHg to 20 mmHg by 2 mmHg Technique Pressure 20 mmHg to 100 mmHg by 5 mmHg Phase Case 3 28 Operator s Manual 110017243EN Rev H 3 Customizing Your System AE II Options Ranges Step Sizes EMEN Aspiration type Fixed vacuum Phase Case Types available Fixed vacuum with aspiration control feature depend on aspiration Linear vacuum types enabled at the Programming Level 2 Linear vacuum with aspiration technique level the control feature dual linear control Fixed flow fixed vacuum option and the mode Fixed flow fixed vacuum with aspiration control feature handpiece type controlling flow selected Fixed flow fixed vacuum with aspiration control feature controlling
88. e off site backup The Ethernet cable that is used to transfer the data can be permanently connected to the Stellaris 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 Stellaris Vision Enhancement System Upon shutdown from the End of Surgery screen the system will prompt you if you would like to Send data to TruLink if in agreement please make sure that the Ethernet cable is connected to the designated port of location and follow instructions After updating the system will shut down automatically 110017243EN Rev H Operator s Manual 1 17 1 Getting Started Multimedia Center MMC optional The MMC is an optional accessory that 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 Connector Status Data is transferred between the MMC and the Stellaris 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 Stellaris Vision Enhancement System Whenever the MMC is on and connected and the Stellaris Vision Enhancement System is in surgical mode the 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 als
89. ectors to 12 0 clock position 110017243EN Rev H Operator s Manual 2 27 2 User Interface BL4393 A Note The battery charging cradle MUST be connected to the wall charger to charge the battery The wireless communication is disabled when the backup cable is in place The Stellaris amp Vision Enhancement System will provide a warning message when the battery is nearing the end of its life Call your customer service representative to get a replacement battery See Chapter 8 for a list of local Bausch Lomb offices 2 28 Operator s Manual 110017243EN Rev H 2 User Interface 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 2 33 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 cont
90. eionized 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 Handpiece Cleaning Instructions A 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 50cc ml mark C Connect the end of the syringe to the irrigation fitting of the handpiece see figure 5 2 D Pushon 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 E Repeat Steps B through D at least three times Aspiration Flusing Irrigation Flushing Figure 5 2 Irrigation Aspiration Handpiece Flushing Setup 1 Handpiece 2 Male luer 3 3 way stockcock 4 Syringe 5 Luer adapter 6 Female luer F _ 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 110017243EN Rev H Operator s Manual 5 5 5 Cleaning and Sterilization Requirements Il H I J K L Z N O A Refill the syringe to the 50cc ml mark with warm 30 C to 40 C or 85 F to 105 F distilled or deionized
91. ent 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 fC LED Symbol for Battery on Foot Control 110017243EN Rev H Operator s Manual 2 19 2 User Interface e Note The out of factory Wireless System Setup is Disabled Software upgrade will also reset the Wireless System Setup to Disabled To setup wireless operation follow steps below 1 Select Programming from Setup or Select Surgeon screens 2 Select System Setup from the Programming screen screen image below 3 Select Foot Control tab from the System Setup screen screen image below 4 Select Wireless Enabled or Disabled to configure Foot Control connection mode 2 20 Operator s Manual 110017243EN Rev H A Note A Note A Note 2 User Interface ZZ z zzr 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 System will disable wireless operation once it detects loss of wireless communication at setup and surgery screens Once wireless connectivity is lost the wireless opperation must be manually reconfigured using the system setup screens The system will disable wireless operation when the battery is replaced or removed while system is in surg
92. ent System is available from Global Product Support either by phone or letter as follows Bausch amp Lomb Incorporated 3365 Tree Court Industrial Blvd St Louis Missouri 63122 U S A Attention Global Product Support e For product support within the U S A call the 24 hour telephone line 1 800 338 2020 or fax 636 226 3070 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 8 4 Please organize your material before calling or writing for technical support Please have the following information ready Customer account number Name of function handpiece etc that needs service Model number REF and serial number SN of Stellaris amp Vision Enhancement System located on the label on the back panel Date of purchase Description of problem listing all observable symptoms and characteristics and details of occurrence Was patient involved at time of occurrence 8 2 Operator s Manual 110017243EN Rev H 8 Service and Warranty EH Returns To return a Stellaris 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 C
93. es of room lighting may cause this type of interference SG71 Check remote functions with A V pop up display on the Remote Control tab SG72 Replace the remote control battery at your earliest convenience SG73 Please ensure that the multimedia center is plugged in and powered on SG74 Check that the multimedia center data cable is plugged in to both the system and the multimedia center SG75 IV Pole valid range is 0 1 cm SG76 IV Pole valid range is 0 1 cm Go to IV Pole more screen or programming function to reset ceiling limit SGT Change Phase Mode while surgical functions not in use SG78 Power down the system and then restart the system 110017243EN Rev H Operator s Manual 7 15 7 Troubleshooting and Maintenance i Er E E EE e rcx Suggestion Suggested Action Text Action ID SG79 Insert the vacuum fluidics cassette SG80 Insert the flow fluidics cartridge and press the Close Drawer button 7 16 Operator s Manual 110017243EN Rev H Foot Control does not automatically transition to wireless operation after disconnecting the Foot Control backup cable System not reading cassette fluid level correctly 110017243EN Rev H 7 Troubleshooting and Maintenance Additional Troubleshooting Guide The Foot Pedal Offset switch not properly engaged System not detecting if foot pedal is offset to Left Right or Center Pedal Pitch Tension Adjustment Knob Pedal Offset Adjusment Switch
94. es will be appropriately labeled as Manufactured By Manufactured For or Distributed By Bausch amp Lomb For a complete list of approved accessories please consult your local Bausch Lomb catalog or contact your local Bausch Lomb representative 110017243EN Rev H Operator s Manual 7 21 7 Troubleshooting and Maintenance SU Description Miscellaneous D8201 Bipolar Eraser 31 Shaft with 45 Degree Bevelled Lemo Connector Miscellaneous E7918 Bipolar Pencil 18g Str 10 box Miscellaneous 2050 B Bipolar Cord with Banana Connector Disposable Miscellaneous 2050 10A Bipolar Forceps Ang McPherson Banana Connector Miscellaneous 2050 10S Bipolar Forceps McPherson Straight Banana Connector 7 22 Operator s Manual 110017243EN Rev H 8 Service and Warranty EH Service and Warranty This chapter contains instruction on how to contact Bausch Lomb to obtain service on your Stellaris Vision Enhancement System as well as warranty and environmental information ea Note Preventative scheduled maintenance is recommended once a year to insure that the Stellaris 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 110017243EN Rev H Operator s Manual 8 1 8 Service and Warranty 8 1 Service Information Technical Assistance Assistance for Stellaris Vision Enhancem
95. ght corner of the video image on the monitor 10 Turn on the Stellaris Vision Enhancement System as directed in Chapter 1 The Stellaris Vision Enhancement System mode and settings information will not be displayed until a surgical mode is entered 11 Verify that the Stellaris amp Vision Enhancement System s mode and setting information is overlaying the video image from the microscope camera on the video monitor 6 6 Operator s Manual 110017243EN Rev H 6 Setup Video Capture The MMC has FireWire DCAM output capability which can be used to send video to a personal computer for video capture To take advantage of this capability you must install software to support your video capture software This software may be obtained by contacting Bausch Lomb Global Product Support ea Note A six foot FireWire cable is provided with the MMC module 110017243EN Rev H Operator s Manual 6 7 6 Setup 6 8 Operator s Manual 110017243EN Rev H 7 Troubleshooting and Maintenance HEEL t Troubleshooting and Maintenance This chapter contains procedures for identifying and resolving problems that may occur with your Stellaris Vision Enhancement System S Note Preventative scheduled maintenance is recommended once a year to insure that the Stellaris Vision Enhancement System meets it optimum performance reliability and safety standards set by the manufacturer The maintenance shall be done by a Bausch Lomb certifie
96. h this SG02 software version Ultrasound module functions not available USMO3 The ultrasound module has failed to respond to a settings command The SG04 module settings have been re sent to the module USMOI The ultrasound module was not detected in the system Ultrasound SGOI coagulation and electric vitrectomy functions not available USMO4 The ultrasound module has reset The module settings have been re sent SG04 to the module SG48 SG49 SG04 USM06 The ultrasound handpiece has not been tuned SG50 USMO07 The ultrasound handpiece tuning is in progress USMOS The ultrasound handpiece has failed the tuning process SG51 SG53 SG52 SG04 SG54 SG53 SG04 SG56 SG55 SG04 SG56 SG55 SG04 USM12 Incorrect ultrasound handpiece connected SG57 SG04 USM13 The electric vitrectomy handpiece is not plugged in to the system USM14 The electric vitrectomy handpiece may have failed SG59 SG58 SG04 SG61 SG60 SG04 USM15 Unable to read ultrasound handpiece data Attempt to tune the handpiece SG53 to confirm proper operation SG04 110017243EN Rev H Operator s Manual 7 9 7 Troubleshooting and Maintenance Vacuum Fluidics Module Messages Text Message Suggested Action s VFMO0I The vacuum fluidics module was not detected in the system Surgical SGOI mode with the vacuum fluidics module is not available VFM02 The vacuum fluidics module software version is not compatible with this SG02 software version
97. he Video Overlay You can set the Video Overlay overscan rate from 0 to 5 110017243EN Rev H Operator s Manual 3 13 3 Customizing Your System Create a New Settings File To create a new surgeon preference file select the Create Tab from the Manage Settings Screen then select the surgeon s file which has settings most like the file you are going to create Once you have highlighted a preference file the techniques in that file will be listed on the right side of the screen Select techniques file by highlighting the tabs on the left hand side of the Techniques list Once the desired techniques are highlighted select Confirm and a keyboard will appear through which you can enter the name for the new 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 5 3 14 Operator s Manual 110017243EN Rev H 3 Customizing Your System 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 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 s
98. he attached protective cap into the open socket Foot Control The Foot Control can use either wired or wireless communication The first time the Stellaris Vision Enhancement System is used you must use the wired connection to establish communication between the Foot Control and the Stellaris Vision Enhancement System For wired communication connect the Foot Control backup cable from the back of the Foot Control to the lower back of the Stellaris Vision Enhancement System A Note The out of factory Wireless System Setup is Disabled Software upgrade will also reset the Wireless System Setup to Disabled To setup wireless operation follow steps of Wireless Foot Control Operations System Setup a section provided in Chapter 2 WARNING For optimum aspiration and reflux performance the patient s eye must be at the same level as the Stellaris Vision Enhancement System aspiration port If this is not possible use the patient eye level offset feature in the programming screen To set up the Stellaris Vision Enhancement System a Plug the power cord into the wall b Turnon the power switch located on the back of the bottom of the system console and wait for animation to finish c Connect the Foot Control backup cable to the system to initiate wireless operation d The battery in the Foot Control must charge at least overnight before it can be used wirelessly To charge the battery you can use one of th
99. i ion Battery Bausch amp Lomb Incorporated Rochester NY 14609 USA PS Bausch amp Lomb Incorporated vw Zeen El Kingston upon Thames pe KT2 6TN UK WRI SWIRKSA 015000635 Rev A EERE 36 VOC PESE 2250 mAh Foot Control Battery Label 9 18 Operator s Manual Bausch amp Lomb Incorporated 106 London Road Kingston upon Thames DS Bausch Lomb Stellaris Foot Control ud Bausch amp Lomb Incorporated Rochester NY 14609 U S A eo rer Bausch amp Lomb Incorporated Kingston upon Thames KT2 6TN UK KA Co Use only with BL4391 REF BL2390 100027076 SN WEFCxxxxx ud CCYY Made in GERMANY LIB E eer FCC ID T7V BCOG Grantee Code UMT BT REMOTE TOU AC 0100757770480821 UMA UL O N 21xxx00000 015000586 Rev E Foot Control Label CE 275 015000587 Rev A Large Remote Control Label 100 240V 2 T 10AL 50 60 Hz 250V 1000 VA 015006219 Rev B System Power and Fuse Label Bausch Lomb Rechargable Li ion Battery seram p 36V Foot Control Battery Compartment Label 4035700 110017243EN Rev H 9 Specifications nn 110017243EN Rev H Operator s Manual 9 19 Index A Accessories 7 21 Actual Phaco Time APT 4 20 Advanced Flow Fluidics 4 12 Agency Certifications 9 3 APT Actual Phaco Time 4 20 Aspiration Handpiece Cleaning 5 5 Sterilization 5 7 Operation 4 7 Aspiration Setup Vacuum Fluidics 4 14 Aspiration Ultrasound 4
100. ical or setup screens To configure system to wireless operation see section on Wireless Foot Control System Setup page 2 20 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 Vision Enhancement System is on then press any Foot Control Button and wait up to ten seconds for communication to be established The ready light identified by the symbol below will turn solid green when the Foot Control is communicating wirelessly with the Stellaris 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 in setup and surgery screens To resume wireless operation refer to the Foot Control Wireless System setup section C LED Symbol for Ready on Foot Control 110017243EN Rev H Operator s Manual 2 21 2 User Interface When not in use the Foot Control can be stored on the back of the Stellaris Vision Enhancement System In some operating configurations the surgeon can change surgical phases using the Foot Control Back Up Power Cord Input Right Toe Button Left Toe Button Foot Pedal Right Heel Button Indicator Lights Left Heel Button Left LED Battery Right LED Wireless Pedal Pitch Ten
101. ighted with a blue or gray background marked with 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 2 10 Operator s Manual 110017243EN Rev H 2 User Interface m ma The Status Tab shows the current status of several footpedal options including communication status battery status and signal strength A V More Screen The A V More 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 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 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 110017243EN Rev H Operator s Manual 2 11 2 User Interface Zi The Screen Display Tab control allows you to ad
102. install the attached protective caps into the cable ports This device complies with Part 15 of the FCC U S Federal Communication Commission 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 Placement of Foot Control During Storage 2 18 Operator s Manual 110017243EN Rev H 2 User Interface p Jom anuit The Foot Control contains an internal rechargeable battery The battery cover has the battery symbol on it The battery needs to be charged overnight prior to initial wireless use and if the system is idle for more than seven days refer to the battery charging options section on page 2 27 Foot Control Battery Installation Guide 1 Place Foot Control upside down on a flat dry surface 2 Open 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 battery with two fingers holding on to the battery 4 Before installing the replacement battery check battery electrical contacts to ensure they are clean and free of contamination 5 Install new battery 6 Press the door toward the compartment and engage door latches to securely close battery door Battery compartment with recess arrows to facilitate battery replacem
103. inutes 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 110017243EN Rev H Operator s Manual 5 7 5 Cleaning and Sterilization Requirements 5 5 Phacoemulsification 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 A Note Use compressed filtered medical grade air medical grade nitrogen to blow out the handpiece lumens The pressure should not exceed 29 psi 200kPa 2bar 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 Note Remove the rubber plugs from the tip of
104. ion 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 You can adjust any of these settings 2 8 Operator s Manual 110017243EN Rev H 2 User Interface m e H a it Coagulation More Settings The Coagulation More Screen shows the current minimum and maximum power levels and the Foot Control Mapping mode You can adjust either power level setting Vitrectomy More Settings The Vitrectomy More Screen shows the current settings for the minimum and maximum CPM cuts per minute You can adjust either setting The current Foot Control Mapping is also shown e Note Foot Control mapping available on Programming Level 2 and 3 only 110017243EN Rev H Operator s Manual 2 9 2 User Interface Footpedal More Settings The Footpedal More 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 2 18 The Settings Tab shows the current status of the Foot Control buttons right or left foot operation Dual Linear Control Mode Change Control Next U S Ultrasound Modulation on Yaw Reflux Type and Fixed Coag Power Editable functions are highl
105. irrigation line from an inverted bottle of Balanced Salt Solution is attached through the Advanced Flow System cartridge to the surgical handpiece The delivery pressure of the irrigation solution is adjusted by varying the height of the bottle in relation to the patient s eye On off control of irrigation is accomplished through the Foot Control or touch screen The inward yaw action of the Foot Control will always provide Continuous Reflux in the irrigation mode overriding the global reflux option that applies in all other modes Irrigation Aspiration A single aspiration port driven by the disposable Advanced Flow System cartridge provides flow control of aspiration Flow Control Aspiration in the flow mode of operation will provide flow rates from 1 ml min to 60 ml min in 1 ml min increments and vacuum limit control from 0 mmHg to 650 mmHg in 5 mmHg increments utilizing the up down spin buttons Aspiration limits are set via the touch screen and adjusted via the Foot Control or remote control There are two modes of flow control Fixed Flow Linear Vacuum Limit and Linear Flow Fixed Vacuum Limit Capsule Polish The capsule polish function is typically accomplished with a lower vacuum limit setting than standard settings These settings may be customized to allow quick entry into a lower vacuum limit level as explained in Chapter 3 4 12 Operator s Manual 110017243EN Rev H 4 Detailed Reference Viscoelastic Removal The viscoel
106. isabled Fixed aspiration submode Linear ultrasound Irrigation Aspiration R2 Disabled with minimum to fixed Next aspiration control vacuum vacuum ns submode feature on limit or flow Fixed aspiration amp linear ultrasound IRI min Minimum Li fe gs inear aspiration REM aspiration Linear ultrasound Masia R2 Aspiration R2 ee on minimum to fixed qais See vacuum vacuum j To max on limit or flow aspiration Min aspiration and D Aspiration on yaw Ultrasound ns Pitch Linear aspiration Linear ultrasound Rr eege Dual Linear Fixed Aspiration NEN Ultrasound R3 Linear U S Linear Function Ultrasound Er mis Disabled u R2 Ttincaraspimion Irrigation RI irrigation aspiration o Ri in Flow R2 Linear Vacuum or Linear Flow Flow or Vacuum RI R2 R3 RI R2 R3 RI R2 R3 RI R3 RI R2 RI Irrigation 2 34 Operator s Manual 110017243EN Rev H 2 User Interface p nun Phase Type Dual Linear Region Pitch Yaw Out Control R2 Linear Aspiration Cutter on off amp fixed vitrectomy when on 2 Pitch R Linear Aspiration Linear Vitrectomy Linear Aspiration R2 Flow Linear Vacuum or Linear Flow Flow and Fixed or Vacuum Vitrectomy when on Only available at Programming Level 2 Only available at Programming Level 3 110017243EN Rev H Operator s Manual 2 35 2 36 Operator s Manual 1
107. itoring electrodes should be placed as far as possible from the surgical electrodes Needle monitoring electrodes are not recommended In all cases monitoring systems incorporating high frequency current limiting devices are 110017243EN Rev H Operator s Manual 9 3 9 Specifications recommended Properly equipped monitors are usually identified as having electrosurgery interference suppression or ESIS options Table of Cables Cabe length DEER ES Guidance and Manufacturer s declaration electromagnetic emissions The Stellaris 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 Emissions test Compliance Electromagnetic environment guidance The Stellaris Vision Enhancement System must emit electromagnetic energy in order to perform its intended function Nearby electronic equipment may be affected RF emissions CISPR 11 RF emissions CISPR 11 SE Harmonic The Stellaris Vision Enhancement System is suitable for Emissions Class A use in all establishments other than domestic establishments IEC61000 3 2 and those directly connected to the public low voltage power Voltage supply network that supplies buildings used for domestic fluctuations purposes wi Complies flicker emissions IEC 611000 3 3 9 4 Operator s Manual 110017243EN Rev H 9 Specifications Guidance and M
108. izing Your System Customize A V Audio Visual To set the parameters for audio and visual functions select the A V Tab on the Surgeon Programming Level 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 each 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 Ce i Ke EES el Tez jm Mi rz 0m 3 12 Operator s Manual 110017243EN Rev H 3 Customizing Your System SESE SSS Customize Video Overlay To set the parameters for the MMC Video Overlay functions select the Video Overlay Tab on the Surgeon Programming Level Screen 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 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 t
109. just the screen brightness change the display format level select the system language and view the programming level Audio Screen Display Brightness i a Disptay Format Lt Format 2 a ann z ZZ Status Bar Format Le Format 2 a e E Screen and Voice Language iosEnglish US Freview t at ap Programming Level Level 2 s y me Lex 29 r em i n 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 on 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 Vier e EE IV Pole Ne See d Eum n Combing US Aneren 1 LT n Combine Sette m Ss Camine Case Istoremntian l nt rg ee Lg NES 2 12 Operator s Manual 110017243EN Rev H 2 User Interface The Remote Control Tab of the A V More Screen allows you to enable or disable the remote control Ca
110. laced in a sterile cover prior to use in the sterile field The remote control transmits an infrared signal to the 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 the figure below 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 Transmitting Signal Light Next Phase Low Battery Light Bottle Height Phaco Vitrectomy or AX Coagulation Previous Phase Flow Reserved for Future Use 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 4 6 Operator s Manual 110017243EN Rev H 4 Detailed Reference 4 5 Advanced Vacuum System Fluidics A Note Each Stellaris Vision Enhancement System has either an Advanced Vacuum Fluidics or an Advanced Flow Fluidics function 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 Vision Enhancement System aspiration port Failure to follow this procedure may result in serious and
111. ldelaparra 4 28108 Alcobendas Madrid Spain Tel 34 91 657 6300 Fax 34 91 661 4266 Tel 34 902 381 010 Fax 34 902 250 310 110017243EN Rev H 8 Service and Warranty EH Operator s Manual 8 9 8 Service and Warranty EH Sweden Denmark Finland Norway and Sweden Bausch amp Lomb Nordic AB S der Malarstrand 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 Taiwan Bausch amp Lomb Taiwan Ltd 11th Floor No 102 Section 4 Civill Boulevard Taipei 10690 Taiwan Republic of China Tel 88 62 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 6510 Fax 66 2 259 6511 8 10 Operator s Manual 110017243EN Rev H 8 Service and Warranty EH 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 4
112. le spike venting port that comes with the system disposable pack in Figure 1 2 Connect the Air Tubing Line male connector to the bottle spike venting port A in Figure 2 3 Connect the Air Tubing Line filter to the microsurgical system air source B in Figure 2 4 Spike and hang the bottle on the hanger at the desired bottle height 5 Use the up and down arrows to select the desired air pressure 6 Turn On the air pump by selecting Off button below the setting display Selecting the same button will turn off the pump Figure 1 Figure 2 gt Note 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 110017243EN Rev H Operator s Manual 4 33 4 Detailed Reference 4 34 Operator s Manual 110017243EN Rev H 5 Cleaning and Sterilization Requirements exce Ha v z_ Cleaning and Sterilization Requirements This chapter provides instructions for cleaning the Stellaris Vision Enhancement System and for cleaning and sterilization of the reusable accessories ea Note Specific instructions for cleaning and sterilization included with any handpiece or accessory take precedence over these instructions 110017243EN Rev H Operator s Manual 5 1 5 Cleaning and Sterilization Requirements 5 1 Stellaris Visi
113. llaris Vision Enhancement System s Phacoemulsification 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 or a disposable cloth or paper wipe while wearing appropriate personal protective equipment may be necessary It is recommended that the Stellaris Vision Enhancement System s Phacoemulsification Handpiece be reprocessed as soon as is reasonably practical following use 110017243EN Rev H Operator s Manual 5 13 5 Cleaning and Sterilization Requirements cz El 2 Connect the lumens of the Stellaris Vision Enhancement System s Phacoemulsification Handpiece to the lumen connectors or adaptors of the washer to allow detergent and rinse water to circulate freely through the lumens of the Stellaris Vision Enhancement System s Phacoemulsification Handpiece Ensure that the Stellaris Vision Enhancement System s Phacoemulsification Handpiece is placed within the washer such that all surfaces of the Stellaris Vision Enhancement System s Phacoemulsification Handpiece components are accessible to the detergent and rinse water during cleaning and the Stellaris Vision Enhancement System s Phacoemulsification Handpiece does not move about excessively during cleaning Process the Stellaris Vision Enhancement System s Phacoemulsification Handpiece according to the conditions listed below Cleaning times and conditions may be adjusted ba
114. lled via reversal of Advanced Flow Pump Linear Cut Range 30 to 800 cuts per minute in 1 cut per minute Rate Mode 8 P P Oneratins increments P Control Linear control of cut rate via the footpedal Parameters Vitrectomy Fixed C ixed Cut Range 30 to 800 cuts per minute in 1 cut per minute Rate Mode S P P Oparatine increments P i Control On Off control of cut via the footpedal Parameters 9 16 Operator s Manual 110017243EN Rev H 9 Specifications zz Pressurized Infusion Specifications Specification Atmospheric air with 0 1 micron hydrophobic filter Persisch SE dg air ees flow rates up to sion 5 standard cubic feet per hour Be Range 1 100mmHg Control 1 mmHg increment 110017243EN Rev H Operator s Manual 9 17 9 Specifications BB I System Labels BauschsLomb Stellaris Bausch amp Lomb Incorporated Rochester NY 14609 U S A Bausch amp Lomb Incorporated EC REP Kingston upon Thames ml Se e CCYY Made in Made ins USA Ox A CE i275 REF BLxxxxx 10nnnnnnn SN SYSnnnnn FCC ID 0015507718 T7V BCO6 C Stollmann E V GmbH FOO UN ONIN I I It 0 I 1xxx0 015000588 Rev E Main System Label Bausch amp Lomb Incorporated tial Rochester NY 14609 U S A Made in U S A A AN KT2 6TN UK 2x AA LJ Jm Zi REF D 2n SN REO 10261 HIA mi ANIL wi Wi Small Remote Control Label Au REF BL4390 Bauschstomb P 3 100027051 SN SSSSS Rechargeable L
115. ly clean the brush after each use and sterilize at the end of each day according to CX7120 Universal Maintenance Kit instructions A 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 50cc 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 e M Os p 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 o Fill the syringe with air reattach to stopcock and push on the syringe plunger to force air through the handpiece Disconnect the syringe T 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 0 C 3 C 206 8 kPa Refer to your institution s policies regarding restrictions on the use of sterilization Automated Cleaning 1 Inspect the Ste
116. metres m Radiated RF 3 V m IEC 61000 4 3 80 MHz to 2 5 GHz 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 o Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 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 and electromagnetic site survey should be considered If the measured field strength in the location in which the Stellaris amp Vision Enhancement System is used exceeds the applicable RF compliance level above the Stellaris amp Vision Enhancement System should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the Stellaris amp Vision Enhancement System gt Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 9 6 Operator s Manual 110017243EN Rev H 9
117. ms 80 ms to 600 ms by 20 ms Linear Front Loaded Back Loaded Reverse Linear Reverse Front Loaded Reverse Back Loaded 3 32 Operator s Manual Phase Case Phase Case Phase Case Phase Case 110017243EN Rev H 3 Customizing Your System Da ca eu Vitrectomy Options Ranges Step Sizes d Fixed cut rate or linear Pneumatic cut rate maximum rate 30 CPM to 800 CPM by 30 CPM Electric 600 CPM to 1500 CPM by 50 CPM Programming 2 Linear Pneumatic cut rate minimum rate 30 CPM to 800 CPM by 30 CPM Electric 600 CPM to 1500 CPM by 50 CPM Programming 2 Foot Linear Front Loaded Back Loaded Reverse Linear Phase control mapping Reverse Front Loaded Reverse Back Loaded 110017243EN Rev H Operator s Manual 3 33 3 Customizing Your System Coagulation Options Ranges Step Sizes Coag Power level 0 to 10 by 1 maximum level 10 to 30 by 2 30 to 100 by 5 Programming Level 2 0 to 10 by 1 Power level minimum 10 to 30 by 2 level 30 to 100 by 5 Programming Level 2 Linear Front Loaded Back Loaded Phase Foot control mapping 3 34 Operator s Manual 110017243EN Rev H 4 Detailed Reference Detailed Reference This chapter provides a detailed reference for each system function and accessory and surgical procedure setup and operation A WARNING Do not use in the presence of flammable anaesthetics disinfectants aerosol sprays or in an oxygen rich atmosphere Note E
118. my functions are only available at Display Level 2 Vacuum D T en IV Pole f em 2 ur ansis avi m c AVE I ATI oan Era oe 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 Electric Vit 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 2 14 Operator s Manual 110017243EN Rev H 2 User Interface 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 You can select the edge of the video to display an animation showing the effect of the handpiece on the eye for the current surgical phase See Chapter 3 for details on customizing your system IV Pole 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 t
119. n disposables pack and insert fluid collection system fusing a vacuum system 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 turn solid when the system captures the cassette e fusing a flow system insert the fluidics cartridge and select Close Drawer System will start cassette vacuum test or cartridge calibration automatically Spike the Balanced Salt Solution bottle and hang it at the desired bottle height Additional step if pressurized infusion is used Connect the Air Tubing Line D4600A to the vent port at the bottle spike and the other end with air filter to the Stellaris 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 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 appropriate vitrectomy cutter pack If you are using the pneumatic cutter connect tubing and the actuation line to the pneumatic port on the Stellaris 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
120. n 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 9 A blown fuse may be indicated by the following conditions 110017243EN Rev H Operator s Manual 7 1 7 Troubleshooting and Maintenance EE With the system off using a known good outlet no power 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 A Note If damage is apparent to either fuse both should be replaced to ensure proper operation a Remove the power cord from the Stellaris 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 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 Fuse Holder Location 7 2 Operator s Manual 110017243EN Rev H 7 Trou
121. nsure tube set connection is secure when connecting to the handpiece and system 4 1 Computer Unit Your Stellaris Vision Enhancement System was designed to be easily upgradeable to take advantage of future technology evolution It includes a 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 forward and 15 back and swiveled 90 right or left The brightness of the display is controlled through the A V More Screen see page 2 11 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 110017243EN Rev H Operator s Manual 4 1 4 Detailed Reference 4 2 System Console The Stellaris Vision Enhancement System modules are integrated into a protective console The console includes a drawer for storing a remote control and the Foot Control backup cable an integrated IV Pole a handle and a hook for storing the Foot Control A Note Do not use the IV Pole for a
122. nt 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 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 110017243EN Rev H Operator s Manual 2 31 2 User Interface m 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 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 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
123. nterface 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 screen The surgeon may be able to continue with the procedure once the error has been rectified Initiate wireless foot control connectivity by pressing one of the foot control buttons momentarily the left LED will light up 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 110017243EN Rev H Operator s Manual 2 5 2 User Interface 2 2 Surgical More Screens More Screens allow easy access to all system parameters The exact More Screen options available will depend on the current state of the system current programming level and other system settings Select the More Screen Button shown below associated with an on screen surgical function to open the corresponding More Screen ps KI More Screens are available for the Fluidics Aspiration and Infusion Ultrasound Coagulation Vitrectomy Footpedal and Audio Visual functions and Case Selection options e Note More Screens for the Fluidics Ultrasound Coagulation and Vitrectomy functions are only available at Display Level 2 2 6 Operator s Manual 110017243EN Rev
124. nto a surgical container Irrigation Aspiration e Note Tubing must not be pulled taut it must be allowed to have a droop or sag between the cassette and the handpiece 110017243EN Rev H Operator s Manual 4 7 4 Detailed Reference A 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 the 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 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 vacuum build up is vented to atmospheric pressure
125. ntrolled 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 23 4 22 Operator s Manual 110017243EN Rev H 4 Detailed Reference Dual Linear Ultrasound Mode with Aspiration in 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 1 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
126. 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 Vision Enhancement System is covered by the following patents 5 331 951 5 370 602 5 388 569 5 406 503 5 624 394 5 795 328 5 910 139 5 964 746 5 991 142 6 045 527 6 055 458 6 077 272 6 081 122 6 083 195 6 106 512 6 203 516 6 251 113 7 168 930 7 445 436 and 7 604 607 additional patents pending Foreign and other patents may also apply Trademarks are trademarks of Bausch amp Lomb Incorporated or its affiliates All other brand product names are trademarks of their respective owners 110017243EN Rev H Preface 1 Preface Power Outputs Training Following system installation at a surgical 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 inst
127. o program system parameters select Programming from main clock menu on the Select Surgeon Programming Level Screen or the Setup Surgical Screen The Main Programming Screen will appear from which you can perform the following functions Manage Settings e System Setup System Configuration e System Calendar TruLink amp Remote Access optional Exit Programming Programming 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 Programming Level Screen or the Setup Surgical Screen In either case the Stellaris Vision Enhancement System will ask if you want to save any changes you have made Select Yes to save your changes and overwrite existing files and No to discard your changes 3 2 Operator s Manual 110017243EN Rev H 3 Customizing Your System LSS 3 1 Manage Settings Select Manage 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 110017243EN Rev H Operator s Manual 3 3 3 Customizing Your System Customize a Settings File To change the settings for a currently existing preference file select the Customize Tab on the Main Pr
128. o touch the outer edge of the video display to toggle between the video display itself and an animation showing the effect of the handpiece in the eye for the currently selected phase If the system has the optional MMC the TruLink Remote Access can be activated by connecting the Ethernet port on the MMC to a designated Internet enabled network connection and enabling the Trulink data download upon shutdown or Remote Access if available in your area function on the Stellaris Vision Enhancement System A Note Off the shelf Ethernet cable may be used with the Stellaris 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 e Multimedia Center must be installed outside of the sterile field e Do not place Balanced Salt Solution bottle or other containers of fluid on top of the Multimedia Center e AC power source for the Multimedia Center must have a Ground Fault Interrupt 1 18 Operator s Manual 110017243EN Rev H 2 User Interface I St User Interface This chapter introduces you to the operating controls displays and terminology used in the Stellaris Vision Enhancement System 2 1 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 Pres
129. o 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 Fluidics More Screen see page 2 7 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 UR IV Pole DT Advance Te Preset Z Surgery A A 1 c d sm Prime and Q Do De Fill eb e Te Button Open Pack semm Insert Cassette Cam w ET em 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 The button shows the current state of the fill system On or Off You can select it to toggle to the other state Air Pressure If 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 110017243EN Rev H Operator s Manual 2 15
130. occur If you have the TruLink option enabled and have selected Shut Down System you will be asked to confirm the system shutdown The system will then ask if you want to upload system data to the Enterprise Server Ensure the Ethernet cable from the port at the bottom of the Stellaris Vision Enhancement System to the hospital network port is connected before attempting to upload data The system will send diagnostic data no patient data is transferred then shut down when complete At the end of the surgical day make sure to recharge the Foot Control as described on page 2 27 110017243EN Rev H Operator s Manual 1 11 1 Getting Started 1 3 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 If you want to move your system to another location follow the steps as listed below 1 Power down normally 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 Store the tray
131. ogramming Screen A list of all surgeon preference files currently loaded on your Stellaris 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 5 These tabs are Profile Technique Foot Control Settings Foot Control Regions Fluidics A V and Video Overlay Each tab allows you to make global changes to system parameters and is described in detail below 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 at the end of this chapter for details on which options can be customized at which level 3 4 Operator s Manual 110017243EN Rev H 3 Customizing Your System p Hanc crc ct 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 Programming Level Screen Select the surgeon s name and use the keyboard interface that appears to modify the name of that file Select the language and a menu 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 3X Vacuum Module Leve Belwct Technique 110017243EN Rev H Operator
132. olar handpieces should be stored in a location that is isolated from the patient All bipolar accessories must be rated for an operating voltage of at least 120V When the device 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 Needle monitoring electrodes are not recommended In all cases monitoring systems incorporating high frequency current limiting devices are recommended The output power selected should be as low as possible for the intended purpose No neutral electrode is required for use of the bipolar function For explanation of Dual Linear Foot Control see page 2 29 Bipolar coagulation is accomplished with the Stellaris Vision Enhancement System Coagulation Function Bipolar forceps or pencil handpieces are used as electrodes 110017243EN Rev H Operator s Manual 4 27 4 Detailed Reference Coagulation power may be adjusted from 0 to 100 of the output power using the up down arrow keys Coagulation modes available are e 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 e Linear coagulation mode Provides an adjustable output between 0 and 100 Power levels are set via s
133. on Enhancement System Advanced Flow module offers a High Speed pneumatic vitrectomy cutter The pneumatic vitrectomy cutter uses pressurized air generated from an internal pump to drive the pneumatically operated guillotine type vitrectomy cutter The vacuum fluidic module provides aspiration to draw the vitreous material into the port and vitreous is then cut and aspirated into the disposable collection container through the attached tubing For detailed instructions for setup and use see page 4 17 4 7 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 Vision Enhancement System aspiration port Failure to follow this procedure may result in serious and permanent patient injury WARNING Assure the handpiece and accessories are sterilized before use as specified Note Do not use StellarisPC Vision Enhancement System posterior or combined packs on a Stellaris system Note Specific instructions for cleaning and sterilization included with the handpiece or accessory take precedence over these instructions a Turn Power on b Press any button on the Foot Control and wait until the right light turns solid green indicting wireless communication has been established c Select Surgeon s Name and select Confirm d Open disposables pack and insert fluid collection system fusing a vacuum sys
134. on Enhancement System Routine Cleaning A WARNING Disconnect AC power before cleaning 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 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 Vision Enhancement System Foot Control and remote control with a soft cloth moistened with cleaning solution on a weekly basis while the Stellaris 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 If the system has an Advanced Vacuum Fluidics module you should clean the fluid level detection lens every three months with a 4 x 4 in gauze pad and isopropyl alcohol 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 Operator s Manual 110017243EN Rev H 5 Cleaning and Sterilization Requirements EH 5 2 Bipolar Coagulation
135. online store for detailed information The use of accessories 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 Vision Enhancement System should not be used adjacent to other equipment If adjacent use is necessary the Stellaris Vision Enhancement System should be Observed to verify normal operation in the configuration in which it will be used A Note The Stellaris 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 amp 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 during the precheck or during surgery 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 mon
136. ontrol position and is reset when the pedal is released to less than 90 of the linear control position Power Single Burst Pedal Position 4 20 Operator s Manual 110017243EN Rev H 4 Detailed Reference When fixed pulse mode is selected the pulse duration and interval may be selected with the screen settings The ultrasound power is controlled by the linear control position of the footpedal Power Fixed Pulse Pedal Position When multiple burst mode is selected a sequence of bursts of ultrasound energy are 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 Power Multiple Burst Pedal Position Ultrasound Submode Up to three sets of ultrasound modulation settings may be stored with each ultrasound mode see Description of Ultrasound Modes page 4 22 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 e Any of the four Foot Control
137. ontroller has failed to respond to a settings command The SG04 module settings have been re sent to the module EIV05 The IV Pole position cannot be determined SG62 SG04 EIV07 The IV Pole is not detecting the home position switch or the IV Pole SG62 motor may have failed SG04 EIV08 The IV Pole panel button sensors have failed or the buttons have been SG65 activated continuously since being powered on SG64 SG04 MultiMedia Center MMC Module Messages Text Message Suggested Action s MMCOI The multimedia center was not detected in the system SG74 SG73 EIV04 he IV Pole controller has reset The module settings have been re sent to SG04 the module MMCO2 The multimedia center software version is not compatible with this SG02 software version The video overlay function is not available MMC03 The multimedia center has failed to respond to a settings command The SG04 module settings have been re sent to the module 110017243EN Rev H Operator s Manual 7 7 7 Troubleshooting and Maintenance Lmm M Remote Control Receiver Module Messages Text Message Suggested Action s RCRO1 The remote control receiver was not detected in the system Remote SGOI control and display backlight control functions are not available RCRO2 The remote control receiver software version is not compatible with this sG02 software version Remote Control is not available RCRO3 The remote control receive
138. oot Control Linear Cut i Range 30 to 800 cuts per minute in 1 cut per minute Rate Mode g P P Operating increments P Control Linear control of cut rate via the footpedal Parameters Vitrectomy Fixed C ixed Cut Range 30 to 800 cuts per minute in 1 cut per minute Rate Mode e P P Operating increments P Control On Off control of cut via the footpedal Parameters The compressor module will provide a minimum of 600 mmHg up to 3 000 feet above sea level A derating of 19 4 mmHG per 1000 ft will be used for operation above 3 000 ft 110017243EN Rev H Operator s Manual 9 15 9 Specifications Advanced Flow Function Specifications Specification Flow Mode Fixed flow fixed vacuum limit Fixed flow linear vacuum limit Modes of Linear flow fixed vacuum limit Operation Linear Flow Linear Vacuum Limit Vacuum Mode Fixed vacuum Linear vacuum Flow Aspiration I A Mode 0 ml min to 60 ml min U S Mode 5 ml min to 60 ml min Flow Mode Vit Mode 0 ml min to 60 ml min Operating Vacuum Limit Parameters I A mode 0 mmHg to 650 mmHg U S 10 mmHg to 650 mmHg Vitrectomy 0 mmHg to 650 mmHg Vacuum Control mmHg increments Vacuum Mode _ I A 0 600 mmHg Operating U S 10 600 mmHg Parameters Vit 0 600 mmHg n WE Gravity feed from I V bottle with On Off control provided in Irrigation cassette Activated via Foot Control Reflux volume depend on operation mode only Note Active reflux volumes will be software contro
139. ootpedal 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 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 the completion of travel A 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 110017243EN Rev H Operator s Manual 2 33 2 User Interface b m Center Foot Control for Anterior Modes Phase Type Dual Linear Region Pitch Yaw Out Control Next D
140. pear 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 5 Attach the Ethernet cable on the back of the Stellaris Vision Enhancement System Computer Unit J Attach the other end of the data communications cable to the Ethernet connector of the MMC L labeled with the Stellaris icon A WARNING Connecting the MMC data communication cable to equipment other than the Stellaris Vision Enhancement System may cause damage to both systems 6 Turnon the microscope camera and the video recorder and or monitor 7 Verify that the image captured by the surgical microscope camera is displayed on the video monitor With the MMC powered off the MMC is operating in a video bypass mode thus the video input is directly connected to the video output 8 Turn on the MMC by pressing the power on off switch The power indicator on the MMC front panel will change from a bright blue to a dimmer blue Note Allow the MMC to stabilize to room temperature before energizing 9 After approximately one minute verify that the Bausch Lomb logo appears in the lower ri
141. permanent patient injury With your Stellaris Vision Enhancement System the irrigation line from an inverted bottle of Balanced Salt Solution is integrated into the tubing manifold at the top of the vacuum cassette The delivery pressure of the Balanced Salt Solution is adjusted by varying the height of the bottle in relation to the patient s eye For pressurized infusion pressure is determined by the pressure setting of the air pump see page 4 31 for details On off control of irrigation is accomplished through the footpedal or via the touch screen As the cassette fills up the system will give a Cassette Nearing Full warning When the fluid level reaches the maximum capacity the system will give a Cassette Full warning After this second warning the aspiration function will be disabled You must replace the fluidics cassette that is either empty or nearly empty and reprime before aspiration will be re enabled Irrigation Aspiration 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 i
142. phase This step will be highlighted on the clock menu If you are performing an ultrasound procedure select Prime and Tune from the menu on the left side of the screen If you are performing a vitrectomy procedure select Prime from the menu on the left side of the screen The selected action will begin and the progress bar at the bottom of the screen will show when it is completed If the system does not pass the system status screen will suggest corrective action Once the system setup has completed successfully the system will automatically move to the main surgical screen Manually selecting Advance to Surgery produces the same result A Note If the system is not primed and tuned the aspiration and phaco functions will be unavailable 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 More Screens see page 2 6 Your system is now ready for the surgical procedure For irrigation aspiration procedures select I A and connect the I A handpiece to the tube set replacing the phaco handpiece Surgical Procedure Conclusion Select End from the clock menu You must confirm that you are ready to end the case and eject the fluid collection device and you will be reminded to close the pinch valves A Note Make sure to close the Irrigation Clamp on the Administration Tube Set before ending
143. pin 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 programmed to provide linear control as a function of angular footpedal displacement 4 28 Operator s Manual 110017243EN Rev H 4 Detailed Reference E Halic cil 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 B Adapter KZ e TEL Lk gt gt 2 Pin Connector Style WEST Lemo Connector a Connect the desired bipolar forceps or pencil to its cable You may need to use an adapter b Connect the bipolar cable to the coagulation connector c Use the spin buttons to adjust the percentage of coagulation power desired d The fixed coagulation function is activated by pressing the programmed Foot Control switch When the switch is released th
144. ppear 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 and format in which the time is displayed select the Date 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 Gau Gx2A 1S PM 1 Le e ER a EGO 0 0j enm mme omm 3 18 Operator s Manual 110017243EN Rev H 3 Customizing Your System pea c x System ID To monitor or change the identifying names of your Stellaris amp 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 amp Vision Enhancement System You can view the system catalog number as well as its installation number 110017243EN Rev H Operator s Manual 3 19 3 Customizing Your System Rooms To assign names to the operating rooms in which your Stellaris Vision Enhancement System is used select the Rooms Tab at the top of the System Setup Screen Select any room the keyboard will appear
145. r 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 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 Post Warranty Information When warranty coverage expires Bausch Lomb is pleased to provide special trade in programs which offer reduced cost replacements with additional warranty coverage Contact your Bausch Lomb sales representative for additional details on current programs 8 14 Operator s Manual 110017243EN Rev H 8 Service and Warranty EH Caution Bausch Lomb is the only authorized service organization for Bausch Lomb ultrasonic handpiece
146. r has failed to respond to a settings command SG04 The module settings have been re sent to the module RCRO4 The remote control receiver has reset The module settings have been SG04 re sent to the module RCR05 Possible interference with remote control receivers Remote control SG71 function may not be available SG70 SG04 RCR06 The remote control battery level is low Remote control function may not SG72 be available shortly SG71 SG04 User Interface Computer UIC Module Messages Text Message Suggested Action s UICOI IV Pole height range is 0 1 cm SG75 Note 0 is IV Pole Min Value and 1 is IV Pole Max Value UICO2 IV Pole height range is 0 1 cm SG76 Note 0 is IV Pole Min Value and 1 is IV Pole Max Value UICO3 Phase Mode change not allowed while surgical functions in use SG77 UICO04 Initialization of surgical system failed Surgical mode not available SG78 SG04 7 8 Operator s Manual 110017243EN Rev H 7 Troubleshooting and Maintenance G Ultrasound Module Messages Text Message Suggested Action s USMO5 The ultrasound handpiece is not connected or detected USMO09 The ultrasound handpiece may have failed or may be failing USMIO Coagulation circuit may have failed potential coagulation output overvoltage condition USMII Coagulation circuit may have failed potential uncommanded or incorrect coagulation output USMO2 The ultrasound module software version is not compatible wit
147. r s Manual Phase Case Phase Case Phase Case Phase Case Phase Case Phase Case Phase Case 110017243EN Rev H Ultrasound 3 Customizing Your System E Options Ranges Step Sizes 2 Ultrasound Modulation Type Fixed power level or linear power maximum level Pulse rate for pulsed modes Duty cycle fixed or maximum for pulsed modes Burst or pulse duration for burst modes or fixed pulse modes Burst interval for fixed pulse modes Maximum duty cycle for multiple burst modes Waveform Ultrasound Disabled Enabled Phase Case Programming Level 2 Linear control power minimum level Programming Level 2 Minimum duty cycle for multiple burst modes 110017243EN Rev H Continuous Phase Case Pulsed Single burst Fixed pulse Multiple burst Programming Level 3 Linear Power Linear Pulse Programming Level 3 Linear Power Linear Duty Cycle Programming Level 3 Dual Linear Multiple Burst Programming Level 3 Variable Power Multiple Burst Programming Level 3 Variable Power Linear Burst 0 to 10 by 1 10 to 30 by 2 30 to 100 by 5 0 PPS to 20 PPS by 1 PPS 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 5 to 95 by 5 Subject to minimum on time of 2 ms and a minimum off time of 2 ms Phase Case Phase Case Phase Case Phase Case Phase Case Phase Case 2 ms to 20 ms by 2 ms 20 ms to 80 ms by 5 ms 80 m
148. ree methods See page 2 21 To use the system immediately use the provided cable to connect the Foot Control directly to the Stellaris Vision Enhancement System e If you purchased the MMC see page 6 4 for setup details 6 3 Multimedia Center MMC optional accessory The Multimedia Center MMC is used to overlay the surgical parameters output from the Stellaris 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 110017243EN Rev H Operator s Manual 6 3 6 Setup E The MMC is NOT intended for diagnostic purposes Installation 1 Assure all equipment is turned off before making any connections Position the MMC L 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 FEIS A G e a G a 5 X FireWire Input from 250 v fo 60 S Video Microscope Camera Composite Video Input from Stellaris USB Pats For Service Only Power Input Output to i For Service Only Display Monitor 6 4 Operator s Manual 110017243EN Rev H 6 Setup Internet Intranet Connection L 55 as De Be ZZ
149. ress bar will display the amount of coagulation power being used in relation to the maximum setting f A tone will signify bipolar coagulation operation if programmed 4 30 Operator s Manual 110017243EN Rev H 4 Detailed Reference 4 11 DigiFlow Pressurized Infusion Function A WARNING When using Pressurized Infusion with Balanced Salt Solution bottle hung on the system automated I V pole the actual intraocular pressure will be higher than the air pressure displayed in the machine The actual intraocular pressure would be equal to air pressure combined with hydrostatic pressure created from the gravity force A Note Specific instruction for cleaning and sterilization included with the handpiece or accessory take precedence over these instructions Note Once pressurized infusion pump is turned ON it will continue to operate even when the function is removed from the screen display Note When using pressurized infusion hang the bottle so that the drip chamber is close to the patient eye level The Pressurized Infusion function infuses a preset air pressure to pressurize the Balanced Salt Solution bottle The pressure generated would force Balanced Salt Solution 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 depen
150. rface screen and the surgical modules and a Foot Control infrared remote control handpieces and other accessories A Note Do not use StellarisPC Vision Enhancement System posterior or combined packs on a Stellaris system IV Pole User Interface Screen System Switch ON OFF Pneumatic Anterior Vit Acuator Handpiece Connectors Expansion Space Fluidic Module One Touch Wheel Locking 1 2 Operator s Manual 110017243EN Rev H 1 Getting Started See c 1 2 Setting Up Your System E DANGER Do not use in the presence of flammable anaesthetics disinfectants aerosol sprays or in an oxygen rich atmosphere WARNING This system should only be operated by personnel who have been trained and are qualified to use this system Do not add unapproved accessories that modify the effective IV pole height gt i WARNING Do not manually force the IV Pole downward if the system is on gt WARNING Do not modify the pole height or manually force the pole height as this could cause an incorrect indication of the bottle height and patient injury gt WARNING When using gravity infusion the ophthalmic irrigation source shall be at or above the patient s eye level to avoid patient injury Before the first use of the Szellaris amp Vision Enhancement System connect the Foot Control as described on page 6 3 The following pages contain an overview for setup and use of your Stellaris Vision Enh
151. rgical 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 physician is ultimately responsible for determining the appropriate procedure for each patient A Note The user interface screens displayed in this manual copy may appear different than what is on your system depending on the 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 Preface 2 110017243EN Rev H Preface SSS Symbols and Notes The following are general definitions of the symbols and precautions used on this equipment and in this manual Ad DANGER gt WARNING gt CAUTION E Note Q 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 or 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 provi
152. rgical Screen will appear e Note As a matter of operator convenience priming is automatically canceled when tuning has been completed or canceled Re tune if either the handpiece or ultrasound needle is changed c 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 d The Actual Vacuum displays the vacuum being used in relation to the maximum 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 4 26 Operator s Manual 110017243EN Rev H 4 Detailed Reference 4 10 Coagulation Function A WARNING gt WARNING gt WARNING gt CAUTION gt CAUTION E Note A Note A Note A Note Check the coagulation power level when changing between extraocular and intraocular cauterization Use only 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 bip
153. rimps dents exposed wires and so on If the handpiece is damaged it should be immediately removed from service Use of 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 WARNING 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 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 The minimum requirements for sterilization are A Note For users in the United Kingdom please refer to page 5 12 for special cleaning and sterilization instructions before proceeding 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 restric
154. rolled by pitch travel and the other linear function is controlled by yaw travel The table on page 2 34 shows the possible combinations of linear control Left Toe Button Foot Pedal Right Toe Button Left Heel Button Left LED Right LED Battery Wireless Right 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 More than one hour of battery life remains Battery is charging Red and Blinking Less than one hour of battery life remains 110017243EN Rev H Operator s Manual 2 29 2 User Interface 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 Footpedal More Screen see page 2 10 The Footpedal More Screen is used to convey the current footpedal configuration and
155. ructions 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 and we don t want you to have to search to find 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 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 meanings 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 su
156. s 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 restocking 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 110017243EN Rev H Operator s Manual 8 15 8 Service
157. s Manual 3 5 3 Customizing Your System Customize Technique To change the techniques available for a particular surgeon or modify their settings select the Technique Tab on the Surgeon Programming Level 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 3 6 Operator s Manual 110017243EN Rev H 3 Customizing Your System nn 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 and A V Various parameters may be adjusted through various tabs as described below e Note The programming level may be increased to allow more control of feature details However once it has been increased it may not be decreased 110017243EN Rev H Operator s Manual 3 7 3 Customizing Your System IS Profile Tab Technique Name Programming Level 1
158. s part of the priming cycle n 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 110017243EN Rev H Operator s Manual 4 25 4 Detailed Reference Phacoemulsification Operation 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 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 Vision Enhancement System Now you are ready to set the operating parameters a From the Main Surgical Screen select the desired surgical mode from the clock menu b Usethe 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 Su
159. s to 600 ms by 20 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 50 to 99 by 5 Subject to a minimum off time of 2 msec and a maximum off time of 1500 msec 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 Phase Case Phase Case Operator s Manual 3 31 3 Customizing Your System Programming Level 2 Foot control mapping for linear control front loaded linear back loaded WB Options Ranges Step Sizes Per Linear Front Loaded Back Loaded Phase Case Programming Level 3 Ramped not programmable Phase Case Waveform Type Programming Level 3 250 ms to 1000 ms by 50 ms Phase Case Waveform duration resolution of 50 ms even with calculator Programming Level 3 25 to 100 by 5 Phase Case Waveform Depth Programming Level 3 Pulsed mode linear pulse rate minimum Programming Level 3 Pulsed mode linear duty cycle minimum Programming Level 3 Burst mode linear duration minimum Programming Level 3 Foot control mapping for second ultrasound linear control 1 PPS to 20 PPS by IPPS 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 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
160. se More Settings The Case More Screen shows the case number total number of rooms in which the Stellaris 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 e 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 110017243EN Rev H Operator s Manual 2 13 2 User Interface 2 3 Surgical Screen Layout A Note Voice confirmation if enabled responds to Foot Control and remote 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 1 Display At Level 1 only the basic controls are displayed A Note More Screens for the Fluidics Ultrasound Coagulation and Vitrecto
161. seconds i Fill the test chamber with irrigating solution then slide over the tip of the handpiece j Select Prime Only A vacuum test is part of the priming cycle k After successful priming and tuning the Main Surgical Screen will appear a Note Hold the handpiece tip towards the ceiling while priming the irrigation line to insure all air has been removed The external components of your system are now ready Continue to set the operating parameters Use a Select the I A mode on the clock menu b Use the spin control buttons to set the desired aspiration vacuum c Confirm that irrigation and aspiration are balanced by pinching the irrigation line and observing that the test chamber dimples d The system is now ready for Irrigation Aspiration Note See Chapter 5 for cleaning and sterilization requirements when surgery is completed 4 8 Vitrectomy Function The Stellaris Vision Enhancement System supports both a pneumatic standard and a high speed electric optional vitrectomy cutter The pneumatic vitrectomy cutter uses pressurized air generated by an internal compressor 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 110017243EN Rev H Operator s Manual 4 15 4 Detailed Reference Vitrectomy Cutter Modes The
162. sed on the degree of soiling present on the Stellaris Vision Enhancement System s Phacoemulsification 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 Vision Enhancement System s Phacoemulsification 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 Neutral pH detergent Adjust concentration according to the detergent manufacturer s directions regarding water quality and the extent of instrument soiling Minimum exposure conditions for thermal disinfection using purified water 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 Following processing carefully inspect the Stellaris Vision Enhancement System s Phacoemulsification Handpiece for cleanliness any evidence of damage and proper operation If residual soiling is apparent reprocess the Stellaris
163. shing 7 14 Operator s Manual 110017243EN Rev H 7 Troubleshooting and Maintenance EE Suggestion Suggested Action Text Action ID SG49 If the handpiece is not detected unplug the handpiece and try another ultrasound handpiece SG50 Select Setup then select Prime and Tune or Tune Only SG51 Please wait for the ultrasound handpiece tuning to complete Ensure ultrasound needle is properly tightened Select Prime and Tune or Tune Only again to repeat the handpiece tuning process SG55 Confirm proper operation of the coagulation handpiece in a beaker of Balanced Salt Solution SG56 Unplug the handpiece and try another bipolar coagulation cord SG57 If the handpiece is not detected unplug the handpiece and try another ultrasound handpiece SG58 Please plug in the electric vitrectomy handpiece The electric vitrectomy connector light is flashing SG59 If the handpiece is not detected unplug the handpiece and try another electric vitrectomy handpiece SG60 Confirm proper operation of the electric vitrectomy handpiece in a beaker of Balanced Salt Solution SG67 Confirm that the bottom and lower rear areas of the system are not blocked from free air flow SG68 Confirm proper system operation System may not be available if needed functions cannot be verified SG69 Call your product service representative if this problem persists with multiple batteries SG70 Turn off or dim room lights Certain typ
164. similarly slow indicates that the time to achieve the desired aspiration will be much longer The response can be changed through the programming interface see Chapter 3 or the Footpedal More Screen see page 2 10 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 In Region 2 aspiration will be either fixed or proportional to footpedal travel as programmed The maximum level is set by the Max Flow Max Vacuum and Vacuum Response Time setting on the touch screen The Actual Flow and 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 Refer to detailed instructions on page 4 14 The only difference when using the Advanced Flow system is that the fluid collection device is a bag instead of a cassette and you must select Close Drawer on the Setup Screen after inserting the cartridge 110017243EN Rev H Operator s Manual 4 13 4 Detailed Reference Vitrectomy Mode Similar to the Vacuum Fluidic module the Stellaris Visi
165. sing On the rear of the main unit 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 A CAUTION To prevent loss of data save data before system shuts down 1 14 Operator s Manual 110017243EN Rev H 1 Getting Started USB Port Access Air Pressure Output Connector IV Pole Control Buttons Cord Wrap Hooks Foot Control Hook Ultrasound Module This module contains five ports for connecting system accessories The top three ports are active and the bottom two are reserved for future use Ultrasound Function Phacoemulsification 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 to minimize such interference a chance interaction 110017243EN Rev H Operator s Manual 1 15 1 Getting Started 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 is for ultrasound handpieces These support phacoemulsification proce
166. sing 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 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 110017243EN Rev H Operator s Manual 2 1 2 User Interface Option List The Option List allows you to select an option A small next to a setting indicates that additional 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 4 Allow Limit Pedal d Allow Remap Pedal Allow No Limiting Not While Active 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 Screen Actual Value Maximum Limil 650 Current Max Settings Le 4 Slider Ring Function Minimum o 2 2 Operator s Manual
167. sion Adjustment Knob Pedal Offset Adjusment Switch Battery Compartment Door 2 22 Operator s Manual 110017243EN Rev H 2 User Interface Foot Control Status and Wireless Signal Strength Meter Display The status of Foot Control operation is represented by an icons display at the 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 Wireless disabled Wired Wireless disabled Wireless 110017243EN Rev H System detecting wired Foot Control System NOT detecting wired connection Possible cause Foot Control cable not connected 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 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 Check battery if Foo
168. st of the system is operating correctly Symptom Action Required Video display not Check video monitor for overscan or underscan adjustments centered on screen or edge off screen No camera video 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 when 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 No overlay logo Is MMC powered up power indicator on displayed Are power cord s connected correctly Check video connections IN OUT S Video Video 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 Rolling video Is camera powered on Video format may not be supported Is monitor set to correct format NTSC or PAL No streaming video Ethernet cable connected on console Camera turned on Check video connections Cycle power on MMC Cycle power on system and power up MMC 110017243EN Rev H Operator s Manual 7 19 7 Troubleshooting and Maintenance SEES Symptom Action Required System modules When the problem occurs the system will automatically turn ON the irrigation reset momentarily valve to provide continuous irrigation System main functions such as aspiration and ultrasound will cease to operate To resume system opera
169. stance 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 controlled 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 1 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 co
170. stem 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 13 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 196 to 10096 using the up down spin buttons Foot Control buttons or remote and 196 increments using the keypad Pulse output control is programmable from 1 to 250 pulses per second in 1 pulse per second 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 phaco 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 c
171. t Control wireless function not established after Step 1 Operator s Manual 2 23 2 User Interface Display Type Foot Control setup stats Action Wireless System detecting No action required Excellent signal strength E Wireless System detecting Good No action required i signal strength 3 Wireless System detecting No action required Moderate signal strength Wireless System detecting Low No action required signal strength 2 24 Operator s Manual 110017243EN Rev H 2 User Interface WEE Display Type Foot Control setup sts Action Wireless System System lost wireless Connect Foot Control disabled wireless setup connection signal during backup cable to resume procedure operation System will automatically configure to wired Note operation System will remain in The icon remains wired configuration until connected with the next time system is Foot Control cable or powered up To configure manually re configures system to wireless system to wireless operation see section on configuration Wireless Foot Control System Setup page 2 20 Note The system will disable wireless operation when the battery is replaced or removed while system is in surgical or setup screens To configure system to wireless operation see section on Wireless Foot Control System Setup page 2 20 Note Irrigation will be turned ON and other functions will be disabled when the system does not detect Foot Control connectivi
172. t 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 At default the vitrectomy cutter is set at On 110017243EN Rev H Operator s Manual 4 19 4 Detailed Reference 4 9 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 The Stellaris phaco handpiece is designed with SureLock a luer lock irrigation connector to prevent tubing coming off during surgery and uses Attune energy management system based on 6 crystal technology and advanced power modulation software see programming section for details 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 actual value are shown on the Surgical Screen display The status bar see page 2 14 visible at the top center of the surgical screen may display the average ultrasound power AVE actual phaco time APT and effective phaco time EPT depending on sy
173. t will turn solid green when full communications have been established When the system check is completed following system power up the Select Surgeon screen will appear e 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 1 6 Operator s Manual 110017243EN Rev H 1 Getting Started Select Options Touch the surgeon s name on the list that appears and it will be highlighted Then select Confirm to load the parameters for that surgeon and advance to the Setup Screen To setup a new surgeon instead of using an existing one select Create New to setup a surgeon preference file for a new surgeon using parameters from an existing surgeon Setup Screen The Setup Screen allows you to set certain procedure parameters and prepare the system for surgical procedures If desired select Select Room 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 and choose the specific technique needle grade and pathology for the current procedure Advance to open pack step by selecting Open Pack Insert Cassette from the clock menu Uninterruptible Operation of Your System Some Stellaris models may have a 60 second memory back up battery This battery is not considered a UPS uninterruptible Power
174. tem 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 turn solid when the system captures the cassette e fusing a flow system insert the fluidics cartridge and select Close Drawer System will start cassette vacuum test or cartridge calibration automatically e After vacuum test or cartridge calibration completes the Setup Screen will display with Prime and Tune as the highlighted function 4 14 Operator s Manual 110017243EN Rev H 4 Detailed Reference pm e eg f Spikethe BSS bottle and hang it at the desired bottle height Additional step if pressurized infusion is used Connect the Air Tubing Line D4600A to the vent port at the bottle spike and the other end with air filter to the Stellaris 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 the I A handpiece Select Show Me Steps for animated setup guide if necessary ga Ensure the irrigation clamp is open and select irrigation OFF to turn the flow on and allow irrigation to fill the tubing up to the handpieces See page 4 5 for details on the irrigation flow button activating the Fill button will turn flow on for 20
175. tem is running on back up battery SG81 power Surgical functions are inhibited System will shut down shortly if SG04 main power input is not restored 110017243EN Rev H Operator s Manual 7 5 7 Troubleshooting and Maintenance ZH Compressor Module Messages Text Message Suggested Action s CPXO01 The compressor module was not detected in the system Surgical mode is SGO1 not available CPX02 The compressor module software version is not compatible with this SG02 software version Surgical mode is not available CPX03 The compressor module has failed to respond to a settings command The SG04 module settings have been re sent to the module CPX04 The compressor module has reset The module settings have been re sent SG04 to the module CPX05 The air pressure output is lower than commanded SG45 SG44 SG04 CPX06 The air pressure output is higher than commanded SG46 SG04 CPX07 The internal air pressure system cannot reach the full pressure expected SG31 SG25 SG04 CPX08 The internal vacuum pump has failed SG47 SG04 7 6 Operator s Manual 110017243EN Rev H 7 Troubleshooting and Maintenance G IV Pole Module Messages Text Message Suggested Action s EIVO1 The IV Pole controller was not detected in the system The motorized IV SGO1 Pole function is not available EIVO2 The IV Pole controller software version is not compatible with this SG02 software version IV Pole function is not available EIV03 The IV Pole c
176. the handpiece one plug and lumen ports two plugs at the end of the handpiece before autoclaving and placing into service for the first time 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 below Rinse the exterior of the handpiece by holding it under cold 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 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 A Note For users in the United Kingdom please refer to page 5 12 for special cleaning and sterilization instructions before proceeding 5 8 Operator s Manual 110017243EN Rev H 5 Cleaning and Sterilization Requirements pee R RED E it Irrigation Port Needle Aspiration Port acm Needle Sleeve Power Cord A CAUTION Use only warm 30 C to 40 C or 85 F to 105 F distilled or deionized water to flush the handpiece Note You may use filtered compresse
177. tion perform the following A Go to Setup screen Replace test chamber on the phaco handpiece B C Select Prime and Tune D Following successful prime and tune the system will go to surgical mode to resume operation GUI hung up and When the problem occurs the system will automatically turn ON the irrigation valve system ceased to provide continuous irrigation System and MMC need to be restarted to resume operation operation To restart system perform the following A Power down system by pressing and holding the standby power switch in front of the system Wait until the system powers down completely Power down MMC by pressing and holding the power switch until the light turns brighter if not already powered down Restart MMC by pressing the power switch Restart system by pressing the standby power switch once Repeat system set up sequence Prime and Tune system to resume operation 7 20 Operator s Manual 110017243EN Rev H 7 Troubleshooting and Maintenance 7 5 System Configurations and Accessories 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 Approved accessori
178. tion bottle and hang it at the desired bottle height Additional step if pressurized infusion is used Connect the Air Tubing Line D4600A to the vent port at the bottle spike and the other end with air filter to the Stellaris 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 g Connect tubing to phaco handpiece Select Show Me Steps for animated setup guide if necessary h Plug handpiece connector to the machine Second connector from the top i Thread and firmly secure the ultrasound needle onto the ultrasound handpiece using a needle wrench j 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 _ Irrigation Sleeve el e A Needle k Ensure the irrigation clamp is open and select irrigation Off to turn flow on and allow the flow to fill the irrigation tubing up to the handpieces See page 4 5 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 m Select Prime and Tune A vacuum test i
179. tions on the use of flash sterilization 5 6 Special Instructions for United Kingdom Users Flush aspiration lumen phaco as follows see figure on page 5 10 A 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 50cc ml mark B Connect the syringe to the center stopcock fitting 5 12 Operator s Manual 110017243EN Rev H 5 Cleaning and Sterilization Requirements exe t H pt C Rotate the stopcock lever to allow flow to the female luer fitting Connect the stopcock female luer fitting to the handpiece aspiration fitting E Pushon 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 F Repeat Steps A through E at least three times G Prepare a neutral pH detergent solution using warm distilled or deionized water per the detergent manufacturer s labeling instructions H Immerse aspiration brush part of CX7120 Universal Maintenance Kit into the detergent solution sufficiently to cover all of the brush bristles I From the rear of the handpiece insert aspiration brush into the aspiration fitting J 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 pull the brush back out Thorough
180. ty in surgical mode Irrigation can be turned OFF from the touch screen 110017243EN Rev H Operator s Manual 2 25 2 User Interface 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 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 For more information about where you can drop off your waste equipment for recycling please contact your local recycling office or electronic waste hauler A 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 shown below while the other battery is being used 2 26 Operator s Manual 110017243EN Rev H 2 User Interface Z z _ Battery Charging Options A Note A Note A Note The battery should be removed from the Foot Control if the system is to be idle for more than seven days To maximize performance the Foot Control batteries BL4390 should be rotated every two months
181. ustomer account number Customer name address and telephone number Name of function handpiece etc that needs service Model number REF and serial number SN of Stellaris amp 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 your local Bausch Lomb representative to determine applicable return policies for your local market 110017243EN Rev H Operator s Manual 8 3 8 Service and Warranty 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 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 and Lomb GmbH Horlgasse 12 Mezzanin TOP 5 1090 Wien Osterreich Tel
182. uum range from 0 to 600 mmHg and uses a rigid 300 ml collection cassette with irrigation and aspiration tubing Pneumatic vitrectomy supports both a Linear Cut Rate and a Fixed Cut Rate from 30 to 800 cpm See page 4 7 for details and Chapter 9 for technical specifications 1 16 Operator s Manual 110017243EN Rev H 1 Getting Started Air Compressor The compressor module provides vacuum for aspiration in Advanced Vacuum systems air pressure for pressurized infusion and air pressure to drive various pinch valves See Chapter 9 for technical specifications Remote Control The remote control allows control of various surgical functions from a distance The receiver for the IR signal is at the bottom of the computer screen See page 4 6 for details of operation and Chapter 9 for technical specifications TruLink 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 amp 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 secur
183. uum sensor test has not been attempted The flow fluidics module cartridge vacuum sensor test is in progress SG14 09 The flow fluidics module cartridge vacuum sensor test has failed MIO The flow fluidics module vacuum sensor has failed SG19 M11 System priming has not been attempted SG20 MI2 System priming is in progress SG21 AFMI3 System priming has failed AFM14 The flow fluidics module vitrectomy cutter output pressure is low Vitrectomy cutter may not be cutting AFMI6 Please insert the flow fluidics cartridge SG80 7 4 Operator s Manual 110017243EN Rev H 7 Troubleshooting and Maintenance EH Power Supply Module Messages Action s The power module battery has exceeded the recommended number of charge cycles Battery back up of the system may not be available The power supply software version is not compatible with this software version Surgical mode is not available The power supply has failed to respond to a settings command The module settings have been re sent to the module The power supply has reset The module settings have been re sent to the module SG04 BPS07 The power module temperature is higher than expected SG67 SG04 BPS08 The power module is at an over temperature condition System shutdown SG67 is imminent SG04 BPS10 The power module battery is failing to charge properly Battery back up SG69 of the system may not be available SG66 BPS11 Main power input has been lost Sys
184. vacuum Fixed flow linear vacuum Programming Level 2 Fixed flow linear vacuum with aspiration control feature controlling flow Programming Level 2 Fixed flow linear vacuum with aspiration control feature controlling vacuum Linear flow fixed vacuum Programming Level 2 Linear flow fixed vacuum with aspiration control feature controlling flow Programming Level 2 Linear flow fixed vacuum with aspiration control feature controlling vacuum Programming Level 3 Linear flow linear vacuum limit available only in Irrigation Aspiration and fixed Vitrectomy modes Fixed vacuum level 0 mmHg to 20 mmHg by 1 mmHg Phase Case or linear vacuum 20 mmHg to 200 mmHg by 5 mmHg maximum level for 200 mmHg to 600 mmHg by 10 mmHg vacuum modes Minimum of 10 mmHg for U S modes 0 ml min to 10 ml min by 1 ml min Phase Case Fixed flow level or 10 ml min to 30 ml min by 2 ml min linear flow maximum 30 ml min to 60 ml min by 5 ml min level for flow modes Minimum of 5 ml min for U S modes Fluidics Fixed 0 mmHg to 20 mmHg by 1 mmHg Phase Case vacuum limit level or 20 mmHg to 200 mmHg by 5 mmHg linear vacuum limit 200 mmHg to 650 mmHg by 10 mmHg maximum level for Minimum of 10 mmHg for U S modes flow modes Programming Level 2 0 mmHg to 20 mmHg by 1 mmHg Phase Case Linear vacuum 20 mmHg to 200 mmHg by 5 mmHg minimum level for 200 mmHg to 600 mmHg by 10 mmHg vacuum modes Minimum of 10 mmHg for U S modes Programming Level 2 0 mmHg to 20 mmHg by 1 mmHg Phas
185. 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 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 H through L 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 Repeat Step N at least three times CAUTION Use only warm 30 C to 40 C or 85 F to 105 F distilled or deionized water to flush the handpiece 5 6 Operator s Manual 110017243EN Rev H 5 Cleaning and Sterilization Requirements i SS Irrigation and I A Handpiece Sterilization A WARNING After sterilization allow 20 minutes for the handpiece to cool before it is used 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 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 m

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