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Bausch & Lomb Stellaris Vision Enhancement System Operator's Manual

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  • Page 1 Operator’s Manual...
  • Page 2 For safety’s sake, please heed these precautions. Patents The Bausch & Lomb Stellaris Vision Enhancement System is covered by the following patents: 5,242,404; 5,331,951; 5,370,602; 5,388,569; 5,406,503; 5,429,601; 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 and 7,445,436;...
  • Page 3 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.
  • Page 4 Preface Symbols and Notes The following are general definitions of the symbols and precautions used on this equipment and in this manual. DANGER: 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. WARNING: 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.
  • Page 5 Preface Direct Current Alternating Current Equipotential Foot Control Ground Remote Control Reception Indicator Battery (Foot Control On/TruLink Access) Dispose of Properly Battery Condition Indicator Manufacturer Serial Number Authorised Representative Date of Manufacture in the European Community Non Ionizing Caution: Consult Electromagnetic Accompanying Documents Radiation...
  • Page 6 Preface 21 CFR 801.109 (b) 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 1-11 Operator’s Manual Preface-5...
  • Page 7 Preface Preface-6 Operator’s Manual 110017243EN Rev. G...

  • Page 8: Table Of Contents

    1 Getting Started 1.1. System Description ..........................1-2 1.2. Setting Up Your System ........................... 1-2 1.3. Moving Your System to Another Location ..................... 1-11 1.4. System Components ..........................1-12 2 User Interface 2.1. Basic Interface Controls........................... 2-1 2.2. Surgical “More Screens” ......................... 2-6 2.3.
  • Page 9 5 Cleaning and Sterilization Requirements 5.1. Stellaris Vision Enhancement System Routine Cleaning ................. 5-2 5.2. Bipolar Coagulation Accessories ......................5-3 5.3. Advanced Flow Fluidics Transducer ......................5-4 5.4. Irrigation and Irrigation/Aspiration Handpieces ..................5-5 5.5. Phacoemulsifi cation Handpiece and Accessories ..................5-8 5.6.

  • Page 10: Getting Started

    Getting Started...
  • Page 11 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. WARNING: Implantable defi brillators present a risk of injury if triggered by a fi brillatory event during intraocular surgery, due to involuntary motion by the patient.

  • Page 12: System Description

    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 interface screen and the surgical modules, and a Foot Control, infrared remote control, handpieces, and other accessories.

  • Page 13: Setting Up Your System

    Do not add unapproved accessories that modify the effective IV pole height. WARNING: Do not manually force the IV Pole downward if the system is on. Before the fi rst use of the Stellaris Vision Enhancement System, connect the Foot Control as described on page 6-4 .
  • Page 14 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.
  • Page 15 The system automatically checks its confi gurations for any changes since the last time it was turned on. Only after the Foot Control has been synchronized to the specifi c Stellaris Vision Enhancement System (see 6-4 ), may you use wireless communication.
  • Page 16 1 Getting Started Select Options Touch the surgeon’s name on the list that appears, and it will be highlighted. Then select Confi rm 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 fi le for a new surgeon, using parameters from an existing surgeon.
  • Page 17 Ensure tube set connection is secure when connecting to the handpiece and system. The Stellaris 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.
  • Page 18 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 fl ash until the handpiece is connected, and then will remain solidly lit.
  • Page 19 1 Getting Started Advance to Surgery Phase 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 fl uidics collection device has been attached and all accessories, tubing and handpieces have been connected, the system will automatically advance to the Prime and Tune phase.
  • Page 20 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.

  • Page 21: Moving Your System To Another Location

    1 Getting Started 1.3. Moving Your System to Another Location WARNING: Do not transport or move system at more than a 5 degree inclination until you have followed the following steps. If you want to move your system to another location, follow the steps as listed below. 1.

  • Page 22: System Components

    1.4. System Components 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 interface screen and the surgical modules, and a Foot Control, infrared remote control, handpieces, and other accessories.
  • Page 23 1 Getting Started Stellaris Vision Enhancement System Console IV Pole User Interface Screen System Switch “ON/OFF” Pneumatic Anterior Vit Acuator Handpiece Connectors Expansion Space Fluidic Module Surgical Tray Drawer 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 housing.
  • Page 24 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 fi ve ports for connecting system accessories. The top three ports are active and the bottom two are reserved for future use.
  • Page 25 0 to 650 mm Hg. The corresponding pack has both irrigation and aspiration tubing and a 500 ml fl uid collection bag which fi ts in a drawer on the front of the Stellaris Vision Enhancement System. Irrigation on/off control is provided by an internal pinch valve.
  • Page 26 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.
  • Page 27 Connectors from Microscope Camera 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.
  • Page 28 1 Getting Started 1-18 Operator’s Manual 110017243EN Rev. G...

  • Page 29: User Interface

    User Interface...

  • Page 30: Basic Interface Controls

    2 User Interface 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.
  • Page 31 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.
  • Page 32 2 User Interface 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.
  • Page 33 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.
  • Page 34 2 User Interface Pop-Up Message Window This type of window appears to display error and warning messages. You should take the appropriate action before the system will continue. Nothing else can be done on the screen while a pop-up window is on the screen. The surgeon may be able to continue with the procedure once the error has been rectifi ed.* * For each message displayed, suggested actions to resolve the condition are displayed.

  • Page 35: Surgical "More Screens

    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.
  • Page 36 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 specifi c to the fl uidics system installed on your system. The specifi c options available will depend on what accessories you have on your system, the current programming level, and other system settings.
  • Page 37 2 User Interface Ultrasound More Settings The Ultrasound More Screen shows the current modulation status and power level. Depending on which type of ultrasound and programming level you are currently using, you may also see number of pulses per second (PPS), duty cycle ( DC), burst duration (BD), and pulse interval (PI), waveform type, waveform depth and waveform duration may also be shown.
  • Page 38 2 User Interface 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.
  • Page 39 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 2-17 ). 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, Refl ux Type, and Fixed Coag Power.
  • Page 40 2 User Interface 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 confi guration for aspects of the display.
  • Page 41 2 User Interface The Screen Display Tab control allows you to adjust the screen brightness, change the display format level, select the system language, and view the programming level. 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.
  • Page 42 2 User Interface The Remote Control Tab of the A/V More Screen allows you to enable or disable the remote control. Case 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.

  • Page 43: Surgical Screen Layout

    2 User Interface 2.3. Surgical Screen Layout Note: Voice confi rmation (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.
  • Page 44 2 User Interface 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.
  • Page 45 2 User Interface 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 fl ow setting, if enabled, with the current actual fl ow value below it.

  • Page 46: Foot Control

    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 install the attached protective caps into the cable ports.
  • Page 47 2 User Interface 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 .
  • Page 48 2 User Interface 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: Step 1: Select “Programming” from Setup or “Select Surgeon” screens. Step 2: Select “System Setup” from the Programming screen (Screen image below, circle). Programming screen 110017243EN Rev.
  • Page 49 2 User Interface Step 3: Select “Foot Control” tab from the “System Setup” screen (Screen image below, circle). System Setup screen Step 4: Select Wireless “Enabled” or “Disabled” to confi gure Foot Control connection mode (Screen image below, arrow). Note: The system setup is for enabling wireless functionality, it does not affect the wired functionality.
  • Page 50 Foot Control will only communicate wirelessly with that specifi c 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.
  • Page 51 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 confi gurations the surgeon can change surgical phases using the Foot Control. Back-Up Power Cord Input...
  • Page 52 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.
  • Page 53 2 User Interface Display Type Foot Control Setup Status Action Wireless System detecting Excellent No action required signal strength Wireless System detecting Good No action required signal strength Wireless System detecting Moderate No action required signal strength 2-24 Operator’s Manual 110017243EN Rev.
  • Page 54 2 User Interface Display Type Foot Control Setup Status Action Wireless System detecting Low signal No action required strength Wireless (System disabled System lost wireless Connect foot controller wireless setup) connection signal during backup cable to resume procedure. operation. System will automatically confi gure to wired operation.
  • Page 55 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.
  • Page 56 2 User Interface Battery Charging Options Note: The battery should be removed from the Foot Control if the system is to be idle for more than seven days. Note: To maximize performance, the Foot Control batteries (BL4390) should be rotated every two months. Upon removal, battery must be charged before it’s stored.
  • Page 57 The wireless communication is disabled when the backup cable is in place. The Stellaris 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 &...
  • Page 58 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.
  • Page 59 2 User Interface Basic Button Operation Note: Voice confi rmation (if enabled) responds to Foot Control and remote control operation. For surgical phase changes, voice confi rmation 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 fi le, and can be modifi ed either through the programming interface (see Chapter 3 ), or in some cases through the Footpedal More Screen (see page 2-10 ).
  • Page 60 2 User Interface 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°...
  • Page 61 2 User Interface 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. •...
  • Page 62 2 User Interface Dual Linear Setup The outward yaw movement provides linear control of the programmed function, relative to footpedal displacement (e.g., 0° to 15° displacement corresponds to 0% to 100% output). When the footpedal is released, it returns to the center position. Inward yaw movement controls refl ux. Yaw Control of Reflux The footpedal may be programmed for use with either the right or left foot.
  • Page 63 2 User Interface Center Foot Control for Anterior Modes Phase Type Dual Linear Region Pitch Yaw Out Control Irrigation Fixed aspiration Disabled Next submode Linear ultrasound Irrigation Aspiration R2 Disabled (with minimum to fi xed aspiration control Next vacuum, vacuum feature on) submode limit, or fl ow...
  • Page 64 2 User Interface Phase Type Dual Linear Region Pitch Yaw Out Control Disabled Irrigation Linear Aspiration & Cutter on/off fi xed vitrectomy when on Aspiration on Irrigation Vitrectomy Pitch** Linear Aspiration Linear Vitrectomy Aspiration on Irrigation Yaw*** Linear Vitrectomy Linear Aspiration Dual Linear Flow*** Irrigation...
  • Page 65 2 User Interface 2-36 Operator’s Manual 110017243EN Rev. G...

  • Page 66: Customizing Your System

    Customizing Your System...
  • Page 67 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 confi guration and instrument parameters. Several default surgeon preference fi les are pre-loaded on the system, and you may copy and modify any of them through the Programming interface.
  • Page 68 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 fi les, and No to discard your changes.

  • Page 69: Manage Settings

    3 Customizing Your System 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 fi le, create a new surgeon preference fi le by copying from an existing one, backup fi les, restore fi les from a backup, or delete surgeon preference fi les.
  • Page 70 3 Customizing Your System Customize a Settings File To change the settings for a currently existing preference fi le, select the Customize Tab on the Main Programming Screen. A list of all surgeon preference fi les currently loaded on your Stellaris Vision Enhancement System will appear.
  • Page 71 3 Customizing Your System Customize Profi le To change the surgeon’s name associated with a settings fi le, or change the default language, select the Profi le 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 fi le.
  • Page 72 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 defi ned 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.
  • Page 73 3 Customizing Your System To add a new technique to the list, select Add, then select any surgeon from the list that appears, and the techniques defi ned for that surgeon will appear. Select a technique and select Confi rm to add that technique the original list.
  • Page 74 3 Customizing Your System • Profi le Tab—Technique Name, Programming Level (1,2,3) • 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.
  • Page 75 3 Customizing Your System 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 specifi c to that function will appear, and can be modifi ed.
  • Page 76 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.
  • Page 77 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 Bottle Type, Patient Eye Level (relative to the aspiration port on the fl uidics system), Ultrasound Needle Type, I/A Tip Type, and Electric Vit Tip Type, by selecting the current setting.
  • Page 78 3 Customizing 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.
  • Page 79 3 Customizing Your System 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.
  • Page 80 3 Customizing Your System Create a New Settings File To create a new surgeon preference fi le, select the Create Tab from the Manage Settings Screen, then select the surgeon’s fi le which has settings most like the fi le you are going to create. Once you have highlighted a preference fi le, the techniques in that fi le will be listed on the right side of the screen.
  • Page 81 3 Customizing Your System Backup a Settings File To backup an existing surgeon preference fi le 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 fi le or fi les to be backed up, the location to which they should be backed up, and select Confi rm (You must select the screen fi rst, then insert device.
  • Page 82 3 Customizing Your System Restore a Settings File To restore an existing surgeon preference fi le 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 fi le or fi les to be restored, and select Confi rm (Must select the screen fi rst, then insert device.
  • Page 83 3 Customizing Your System Delete a Settings File To delete an existing surgeon preference fi le, make sure the Delete Tab is active at the top of the Manage Settings Screen, select the fi le or fi les to be deleted, and select Confi rm. 110017243EN Rev.

  • Page 84: System Setup

    3 Customizing Your System 3.2. System Setup Select System Setup from the Main Programming Screen, and a new screen will appear through which you can set the Date/Time for the system, view the System IDs, and set operating room parameters. Any changes you make here are implemented immediately.
  • Page 85 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 Vision Enhancement System. You can view the system catalog number as well as its installation number.
  • Page 86 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, and you can enter the name for that room.

  • Page 87: System Configuration

    3 Customizing Your System 3.3. System Configuration To see a detailed listing of the software and hardware confi guration of your system, select System Confi guration from the Main Programming Screen. 110017243EN Rev. G Operator’s Manual 3-21...

  • Page 88: System Calendar

    The third column contains option lists with the names of all the surgeon preference fi les currently available. Select a fi le from the list, and that will be the default fi le when the Stellaris Vision Enhancement System starts up at that time.

  • Page 89: Trulink Remote Access

    3 Customizing Your System 3.5. TruLink Remote Access WARNING: You must contact your local Bausch & Lomb sales and support offi ce before activating the TruLink Remote Access function. See “Technical Assistance” on page 8-2 for the sales and support offi ce that serves your location.
  • Page 90 Confi rm that the system is not being used for surgery. The system will then be controlled by the remote technician. When the remote technician is fi nished, your Stellaris Vision Enhancement System will be shut down. You may then restart the system.

  • Page 91: Customization Levels

    3 Customizing Your System 3.6. Customization Levels The following tables detail which options can be customized at which levels. Audio/Visual Customization Level Parameter Options, Ranges, Step Sizes Surgeon name Typewriter data entry (30 characters max) Surgeon Screen / voice language English Surgeon Display backlight...
  • Page 92 3 Customizing Your System Case Customization Levels Parameter Options/Ranges/Step Sizes Programming Level 1, Level 2, Level 3 Technique Level Programming Disabled, Enabled Technique, Level 2 Phase Customize Settings by Case Programming Disabled, Enabled Technique Level 2 Customize Fluidics Settings by Needle/Tip Programming Disabled, Enabled Technique...
  • Page 93 3 Customizing Your System Parameter Options/Ranges/Step Sizes Programming Typewriter data entry (20 characters max) Technique Level 2 Pathology Name Phase Name Typewriter data entry (8 characters max) Phase Mode Type Ultrasound, Irrigation/Aspiration, Irrigation, Phase Coagulation, Pneumatic Vitrectomy, Electric Vitrectomy Mode Icon All icons for the given mode type Phase Ultrasound...
  • Page 94 3 Customizing Your System Foot Control Parameter Options/Ranges/Sizes Operation Right Foot, Left Foot Surgeon Mode change Not While Active, Allow-Limit Pedal, Allow- Surgeon control Remap Pedal, and Allow-No Limiting Detents Disabled, Enabled (R1/R2/R3), Enabled (R2/R3) Surgeon Starting Region 1: 2% to 5%<R2 start, by 5% Surgeon position Region 2: 5%>R2 start to 5%<R3 start, by 5%...
  • Page 95 3 Customizing Your System Parameter Options/Ranges/Sizes Dual Linear Mode Level: (If Enabled at Technique Level) Phase Control 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 fl uidics if fl ow modes enabled) Vit Modes: Disabled, Asp on Pitch, Programming Level 3 Asp on Yaw, Programming Level 3 Dual...
  • Page 96 3 Customizing Your System Fluidics Parameter Options/Ranges/Step Sizes Max bottle 30 to 140 cm, by 5 cm System height 500 ml Bottle, 500 ml Bag, 250 ml Bottle Surgeon Container Type Patient Eye -15 cm to +15 cm Surgeon Level Default Standard, MicroFlow+, MicroFlow, Thin Tip, Surgeon...
  • Page 97 3 Customizing Your System Parameter Options/Ranges/Step Sizes Pressurized 0 mmHg to 20 mmHg, by 2 mmHg Technique, Infusion 20 mmHg to 100 mmHg, by 5 mmHg Phase/Case Pressure Aspiration • Fixed vacuum, Phase/Case type • Fixed vacuum, with aspiration control feature Types •...
  • Page 98 3 Customizing Your System Parameter Options/Ranges/Step Sizes Fluidics 0 mmHg to 20 mmHg by 1 mmHg Phase/Case - Fixed 20 mmHg to 200 mmHg by 5 mmHg vacuum limit 200 mmHg to 650 mmHg by 10 mmHg level or linear Minimum of 10 mmHg for U/S modes vacuum limit maximum...
  • Page 99 3 Customizing Your System Parameter Options/Ranges/Step Sizes Programming 0 mmHg to 20 mmHg by 1 mmHg Phase/Case Level 2 Linear 20 mmHg to 200 mmHg by 5 mmHg vacuum limit 200 mmHg to 650 mmHg by 10 mmHg minimum Minimum of 10 mmHg for U.S modes level, for fl ow modes Programming...
  • Page 100 3 Customizing Your System Ultrasound Parameter Options/Ranges/Step Sizes Ultrasound Continuous Phase/Case Modulation Pulsed Type 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...
  • Page 101 3 Customizing Your System Parameter Options/Ranges/Step Sizes Waveform Disabled, Enabled Phase/Case Ultrasound Programming 0% to 10% by 1% Phase/Case Level 2 Linear 10% to 30% by 2% control power 30% to 100% by 5% minimum level Programming 1% to 10% by 1% Phase/Case Level 2 10% to 30% by 2%...
  • Page 102 3 Customizing Your System Parameter Options/Ranges/Step Sizes Programming 5% to 95% by 5% Phase/Case Level 3 Pulsed Subject to minimum on time of 2 ms and a mode linear minimum off time of 2 ms duty cycle minimum Programming 2 ms to 20 ms by 2 ms Phase/Case Level 3 Burst 20 ms to 80 ms by 5 ms...
  • Page 103 3 Customizing Your System Vitrectomy Parameter Options/Ranges/Step Sizes Fixed cut rate Pneumatic: Phase or linear cut 30 CPM to 800 CPM by 30 CPM rate maximum Electric: rate 600 CPM to 1500 CPM by 50 CPM Programming Pneumatic: Phase 2 Linear cut 30 CPM to 800 CPM by 30 CPM rate minimum Electric:...
  • Page 104 3 Customizing Your System Coagulation Parameter Options/Ranges/Step Sizes Coag - Power 0% to 10% by 1% Phase level 10% to 30% by 2% maximum 30% to 100% by 5% level Programming 0% to 10% by 1% Phase Level 2 Power 10% to 30% by 2% level 30% to 100% by 5%...

  • Page 105: Detailed Reference

    Detailed Reference...

  • Page 106: Computer Unit

    Ensure 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 18.1 inch, 5:4 aspect ratio color touch screen display, which is the primary interface between you and your system.

  • Page 107: System Console

    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.
  • Page 108 4 Detailed Reference Fuse holder Main Power Switch Ethernet Port Power Cord Input Power Cord Retention Clip 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.
  • Page 109 4 Detailed Reference IV Pole User Interface Screen System Switch “ON/OFF” Pneumatic Anterior Vit Acuator Expansion Space Handpiece Connectors Fluidic Module Surgical Tray Drawer One-Touch Wheel Locking 4-4 Operator’s Manual 110017243EN Rev. G...

  • Page 110: Pole

    CAUTION: Do not manually force the IV Pole or use the IV Pole as a handle. The Stellaris Vision Enhancement System IV Pole is an integral part of the system console. It can be directly moved up, down, or to a specifi c 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 console.

  • Page 111: Remote Control

    4 Detailed Reference 4.4. Remote Control CAUTION: The remote control is not waterproof and is not sterilizable. The remote control must be placed in a sterile cover prior to use in the sterile fi eld. 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.

  • Page 112: Advanced Vacuum System Fluidics

    WARNING: For optimum aspiration and refl ux 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.
  • Page 113 Advanced Vacuum system, by irrigation pressure. The Stellaris Vision Enhancement System’s Advanced Vacuum system is designed for use with continuous refl ux, but for any surgical mode refl ux may be programmed to be either continuous or off (none). If enabled, the refl ux feature is activated by inward movement of the footpedal in all aspiration modes.
  • Page 114 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: Stop operation and protects handpiece with test chamber.
  • Page 115 4 Detailed Reference Assemble tubing manifold by fi rst sliding the front end under the cassette retainer (R). Press the manifold to engage manifold latch. Connect aspiration tubing to the cassette connector. Insert cassette to the system. Release irrigation clamp. Select “Prime Only”...

  • Page 116: Advanced Flow System Fluidics

    WARNING: For optimum aspiration and refl ux 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.
  • Page 117 4 Detailed Reference 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 higher vacuum limit level as explained in Chapter 3 . Venting The Advanced Flow Fluidics system provides the surgeon with either air or fl uid venting options to free an occluded tip when the footpedal is released.

  • Page 118: Irrigation And Aspiration Setup

    WARNING: For optimum aspiration and refl ux 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.
  • Page 119 4 Detailed Reference c. Select Surgeon’s Name and select Confi rm. d. Open disposables pack and insert fl uid collection system: • If using a vacuum system, insert the fl uidics cassette all the way in and hold until it is automatically captured by the system.

  • Page 120: Vitrectomy Function

    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.
  • Page 121 WARNING: For optimum aspiration and refl ux 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.
  • Page 122 Select Close to close the animated setup guide. b. Open vitrectomy cutter pack. Connect aspiration tubing and the actuation line to the pneumatic port on the Stellaris Vision Enhancement System. c. Ensure that the irrigation clamp is open and the tip is immersed in irrigation solution. Select Setup, then Pneumatic Vit Test.
  • Page 123 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.

  • Page 124: Ultrasound Function

    4 Detailed Reference 4.9. Ultrasound Function Phacoemulsifi cation 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™...
  • Page 125 4 Detailed Reference When fi xed 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.
  • Page 126 4 Detailed Reference Description of Ultrasound Modes The application of ultrasound power may be fi xed 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.
  • Page 127 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 fi ve 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.
  • Page 128 WARNING: For optimum aspiration and refl ux 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.
  • Page 129 4 Detailed Reference e. After vacuum test or cartridge calibration completes, the Setup Screen will appear with Prime and Tune as the highlighted function. f. Spike the 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 fi lter to the Stellaris air output connector.
  • Page 130 4 Detailed Reference 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.

  • Page 131: Coagulation Function

    Note: For explanation of Dual Linear Foot Control see page 2-23 . Bipolar coagulation is accomplished with the Stellaris Vision Enhancement System Coagulation Function. Bipolar forceps or pencil handpieces are used as electrodes. Coagulation power may be adjusted from 0% to 100% of the output power using the up/down arrow keys.
  • Page 132 4 Detailed Reference Fixed Coagulation Setup and Use WARNING: Assure the handpiece and accessories are sterilized before use. 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. Specifi c instructions for cleaning and sterilization included with the handpiece or accessory take precedence over these instructions.
  • Page 133 4 Detailed Reference Linear Coagulation Setup and Use WARNING: Assure the handpiece and accessories are sterilized before use as specifi ed. Note: Specifi c 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.

  • Page 134: Pressurized Infusion Function

    4 Detailed Reference 4.11. DigiFlow™ Pressurized Infusion Function WARNING: When using Pressurized Infusion with BSS 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.
  • Page 135 4 Detailed Reference Enable Pressurized Infusion Function If system is installed with Pressurized Infusion software, the function could be enabled from surgeon fi le programming or surgical More Screen. To enable Pressurized Infusion Function from surgical More Screen: Ensure surgical screen Format 2 is displayed. Select fl uidic More Screen button (A double arrow up button below the vacuum preset display.) Select Infusion Tab of the pop up screen.
  • Page 136 4 Detailed Reference Pressurized Infusion Setup Remove the fi lter cap (A) from the bottle 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.
  • Page 137 4 Detailed Reference 4-32 Operator’s Manual 110017243EN Rev. G...
  • Page 138 Cleaning / Sterilization...

  • Page 139: Cleaning And Sterilization Requirements

    5 Cleaning and Sterilization Requirements Cleaning and Sterilization Requirements This chapter provides instructions for cleaning the Stellaris Vision Enhancement System, and for cleaning and sterilization of the reusable accessories. Note: Specifi c instructions for cleaning and sterilization included with any handpiece or accessory take precedence over these instructions.

  • Page 140: Stellaris Vision Enhancement System Routine Cleaning

    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. • Isopropyl alcohol (70%) •...

  • Page 141: Bipolar Coagulation Accessories

    5 Cleaning and Sterilization Requirements 5.2. Bipolar Coagulation Accessories WARNING: The coagulation accessories should not be sterilized using a cold soaking solution. 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 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.

  • Page 142: Advanced Flow Fluidics Transducer

    The transducer should be cleaned on a weekly basis. Refer to fi gure for the following instructions. Transducer A. The Stellaris Vision Enhancement System must be in an Advanced Flow System operating mode. B. Open the drawer by pressing the Open Drawer button.

  • Page 143: Irrigation And Irrigation/Aspiration Handpieces

    5 Cleaning and Sterilization Requirements 5.4. Irrigation and Irrigation/Aspiration Handpieces CAUTION: Use only warm (30° C to 40° C or 85° F to 105° F) distilled or deionized water to fl ush the handpiece. The handpiece must be cleaned and autoclaved before it is placed into service the fi rst time, before initial use each day, and between each use in accordance with the following instructions.
  • Page 144 5 Cleaning and Sterilization Requirements H. Refi ll the syringe to the 50cc (ml) mark with warm (30° C to 40° C or 85° F to 105° F) distilled or deionized water. I. Connect the syringe to the center stopcock fi tting. J.
  • Page 145 5 Cleaning and Sterilization Requirements Irrigation and I/A Handpiece Sterilization WARNING: After sterilization allow 20 minutes for the handpiece to cool before it is used. WARNING: Do not cold sterilize the instrument. The sterilizing solution may not be fl ushed out prior to surgery and could be fl ushed into the eye, resulting in serious eye injury.

  • Page 146: Phacoemulsification Handpiece And Accessories

    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.
  • Page 147 5 Cleaning and Sterilization Requirements Irrigation Port Needle Aspiration Port Needle Sleeve Power Cord CAUTION: Use only warm (30° C to 40° C or 85° F to 105° F) distilled or deionized water to fl ush the handpiece. Note: You may use fi ltered compressed medical grade air (medical grade nitrogen) to blow out the tubing. The pressure should not exceed 29 psi (200 kPa, 2 bar).
  • Page 148 5 Cleaning and Sterilization Requirements Syringe Handpiece D. Flush the aspiration lumen as follows (see fi gure below): 1. From the rear of the handpiece, insert aspiration brush (provided in the CX7120 Universal Maintenance Kit) into the aspiration fi tting. 2.
  • Page 149 5 Cleaning and Sterilization Requirements Handpiece Fluid Pathway 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 5-8 . B.
  • Page 150 5 Cleaning and Sterilization Requirements Phacoemulsifi cation Handpiece and Accessories Sterilization WARNING: Before each use, the handpiece and power cord should be inspected for damage (nicks, crimps, dents, exposed wires, and so on). If the handpiece is damaged, it should be immediately removed from service. Use of damaged handpiece may result in serious permanent patient injury.

  • Page 151: High Speed Vitrectomy Handpieces

    5 Cleaning and Sterilization Requirements 5.6. High Speed Vitrectomy Handpieces The handpiece, disposable tips, and reusable cord should be inspected before each use for signs of misalignment, pitting, contamination, or other damage. Wipe the handpiece using a soft cloth moistened with a mild soap water solution.

  • Page 152: Special Instructions For United Kingdom Users

    5 Cleaning and Sterilization Requirements 5.7. Special Instructions for United Kingdom Users Flush aspiration lumen (phaco) as follows (see fi gure on 5-11 ): A. Place the end of the syringe into a beaker of warm (30° C to 40° C) distilled or deionized water, and fi ll the syringe to the 50cc (ml) mark.
  • Page 153 5 Cleaning and Sterilization Requirements L. Wipe each end of the handpiece with clean gauze to remove any deposited protein material. M. Refi ll the syringe with 50cc (ml) of warm distilled or deionized water. N. Connect the end of the syringe to the center stopcock fi tting. O.
  • Page 154 5 Cleaning and Sterilization Requirements Automated Cleaning Inspect the Stellaris Vision Enhancement System’s Phacoemulsifi cation 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.

  • Page 155: Cleaning The Mmc

    5 Cleaning and Sterilization Requirements 5.8. Cleaning the MMC CAUTION: To preserve the chassis fi nish, avoid the use of abrasive cleaners. If possible, clean spots before they dry. WARNING: Disconnect AC power before cleaning the chassis. The following cleaning solutions are recommended to clean the MMC. •...
  • Page 156 5 Cleaning and Sterilization Requirements 5-18 Operator’s Manual 110017243EN Rev. G...

  • Page 157: Setup

    Setup...
  • Page 158 6 Setup Setup This chapter provides information for setting up your Stellaris Vision Enhancement System and making necessary connections. DANGER: Do not use in the presence of fl ammable anaesthetics, disinfectants, aerosol sprays, or in an oxygen rich atmosphere. WARNING: All external wiring must be in accordance with local electrical code requirements and NEC Class II signaling system twisted wire with outer shield.

  • Page 159: Setup Instructions

    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 Vision Enhancement System is pre-confi gured at the factory to minimize setup and installation requirements. The following information explains the connections for the Foot Control, power cable and MMC (optional).
  • Page 160 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 the attached protective cap into the open socket.

  • Page 161: Multimedia Center (Mmc) (Optional Accessory)

    6 Setup 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.
  • Page 162 6 Setup Internet/Intranet Connection AC Electrical Power Source Optional Connection Video Camera Without Recording Device (Not Supplied) Monitor (Not Supplied) Optional Video Recorder (Not Supplied) 2. 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.
  • Page 163 9. After approximately one minute, verify that the Bausch & Lomb logo appears in the lower right corner of the video image on the monitor. 10. Turn on the Stellaris Vision Enhancement System as directed in Chapter 1 . The Stellaris Vision Enhance ment System mode and settings information will not be displayed until a surgical mode is entered.
  • Page 164 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.
  • Page 165 6 Setup 6-8 Operator’s Manual 110017243EN Rev. G...
  • Page 166 Troubleshooting / Maintenance...

  • Page 167: Troubleshooting And Maintenance

    Fuse Replacement The Stellaris Vision Enhancement System has 2 user-replaceable fuses. If an over-current condition should occur which opens these fuses, they should be replaced with fuses of the same value as the original fuses (see specifi cations table in Chapter 9 ).
  • Page 168 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.

  • Page 169: Error And Warning Messages

    7 Troubleshooting and Maintenance 7.3. Error and Warning Messages All error 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 error occurs, the system will sound the error tone and display a pop-up window with the error displayed.
  • Page 170 7 Troubleshooting and Maintenance Flow Fluidics Module Error Messages Error ID Text Message Suggested Action(s) The fl ow fl uidics module was not detected in the system. AFM01 SG01 Surgical mode with the fl ow fl uidics module is not available. The fl ow fl uidics module software version is not compatible with this AFM02 SG02...
  • Page 171 7 Troubleshooting and Maintenance Power Supply Module Error Messages Error ID Text Message Suggested Action(s) The power module battery has exceeded the recommended number BPS01 SG66 of charge cycles. Battery back-up of the system may not be available. BPS02 The power supply was not detected in the system. SG01 The power supply software version is not compatible with this BPS03...
  • Page 172 7 Troubleshooting and Maintenance Compressor Module Error Messages Error ID Text Message Suggested Action(s) The compressor module was not detected in the system. CPX01 SG01 Surgical mode is not available. The compressor module software version is not compatible with this CPX02 software version.
  • Page 173 7 Troubleshooting and Maintenance IV Pole Module Error Messages Error ID Text Message Suggested Action(s) The IV Pole controller was not detected in the system. EIV01 SG01 The motorized IV Pole function is not available. The IV Pole controller software version is not compatible with this EIV02 SG02 software version IV Pole function is not available.
  • Page 174 7 Troubleshooting and Maintenance Remote Control Receiver Module Error Messages Error ID Text Message Suggested Action(s) The remote control receiver was not detected in the system. RCR01 SG01 Remote control and display backlight control functions are not available. The remote control receiver software version is not compatible with this RCR02 SG02 software version.
  • Page 175 7 Troubleshooting and Maintenance Ultrasound Module Error Messages Error ID Text Message Suggested Action(s) The ultrasound module was not detected in the system. USM01 SG01 Ultrasound, coagulation, and electric vitrectomy functions not available. The ultrasound module software version is not compatible with this USM02 software version.
  • Page 176 7 Troubleshooting and Maintenance Vacuum Fluidics Module Error Messages Error ID Text Message Suggested Action(s) The vacuum fl uidics module was not detected in the system. VFM01 SG01 Surgical mode with the vacuum fl uidics module is not available. The vacuum fl uidics module software version is not compatible with this VFM02 SG02 software version.
  • Page 177 7 Troubleshooting and Maintenance Foot Control Module Error Messages Error ID Text Message Suggested Action(s) SG32 The foot controller battery has exceeded 300 charge cycles. WFC01 SG33 The foot controller battery may not provide power for the entire day. SG34 The foot controller does not have valid factory calibration data.
  • Page 178 7 Troubleshooting and Maintenance Error ID Text Message Suggested Action(s) SG83 WFC20 The system has lost communication with the foot controller. SG34 SG04 Foot Control Receiver Module Error Messages Error ID Text Message Suggested Action(s) The foot controller receiver was not detected in the system. WFR01 SG01 Surgical mode is not available.
  • Page 179 7 Troubleshooting and Maintenance Suggested Actions for Error Messages Suggestion Suggested Action Text Action ID SG01 Call your product service representative. Call your product service representative. SG02 A compatible software version must be downloaded. SG03 Confi rm correct irrigation, aspiration, and vitrectomy function. SG04 Call your product service representative if this problem persists.
  • Page 180 7 Troubleshooting and Maintenance Suggestion Suggested Action Text Action ID SG23 Select ‘Eject Cassette’ , load a new pack, and try priming the system again. SG24 Select ‘Open Drawer’ , load a new pack, and try priming the system again. SG25 Confi rm correct irrigation and aspiration function.
  • Page 181 7 Troubleshooting and Maintenance Suggestion Suggested Action Text Action ID Check that there are no leaks in the air line and that the air line tubing is connected tightly SG45 to the other pack components. Turn the pressurized infusion pump off, wait for a few seconds, and then turn the pump SG46 back on.
  • Page 182 7 Troubleshooting and Maintenance Suggestion Suggested Action Text Action ID 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. Check that the multimedia center data cable is plugged in to both the system and the SG74 multimedia center.
  • Page 183 7 Troubleshooting and Maintenance Additional Troubleshooting Guide Symptom Potential Cause Corrective Action Foot Control lost Pitch The Foot Pedal Offset switch not properly Check Offset switch at the control of Region 2,3 and engaged. System not detecting if foot pedal back of the foot pedal, Yaw.

  • Page 184: Troubleshooting The Mmc

    No overlay Are power cord(s) connected correctly? logo displayed Check video connections: IN/OUT, S-Video/Video. No settings Is the Stellaris Vision Enhancement System in a surgical mode? displayed Is the data cable connected correctly? Overlayed displays Check monitor adjustments. not visible...
  • Page 185 7 Troubleshooting and Maintenance Symptom Action Required Ethernet cable connected? Camera turned on? No streaming video Check video connections on console Cycle power on MMC. Cycle power on system and power up MMC. When the problem occurs, the system will automatically turn “ON” the irrigation valve to provide continuous irrigation.

  • Page 186: System Configurations, Modules, Accessories And Packs

    The system confi guration, module, accessory and pack lists provided on the following pages are to be used with the Stellaris Vision Enhancement System. Although not provided in the list; the phaco needles, I/A handpiece, I/A tips, vitrectomy cutters and bipolar accessories for the Millennium Microsurgical System are compatible and could be used with the Stellaris Vision Enhancement System.
  • Page 187 7 Troubleshooting and Maintenance Group Description System Confi guration BL11110 Anterior Deluxe Advanced Vacuum System System Confi guration BL11120 Anterior Deluxe Advanced Flow System System Confi guration BL12110 Anterior Deluxe Advanced Vacuum System with HSV System Confi guration BL12120 Anterior Deluxe Advanced Flow System with HSV Module BL2120 Advanced Flow Fluidic Module (AFM)
  • Page 188 7 Troubleshooting and Maintenance Group Description Accessory BL3167 I/A 0.3 tip Straight - Metal Outer Cannula 17.5 Gauge Accessory BL3168 I/A 0.3 tip Angled 45 Deg - Metal Outer Cannula 17.5 Gauge Accessory DP9731 I/A 0.3 Tip Straight‚ Silicone Sleeve Accessory DP9733 I/A 0.3 Tip Angled 45 Deg‚...
  • Page 189 7 Troubleshooting and Maintenance Group Description Accessory BL3153NO Stellaris User Manual Print Binder, Norwegian Accessory BL3153DA Stellaris User Manual Print Binder, Danish Stellaris User Manual Print Binder, Finnish Accessory BL3153FI Accessory BL3153EL Stellaris User Manual Print Binder, Greek Accessory BL3153CS Stellaris User Manual Print Binder, Czech Stellaris User Manual Print Binder, Hungarian Accessory...
  • Page 190 7 Troubleshooting and Maintenance Group Description Miscellaneous BL4351US System Power Cord, United States Miscellaneous BL4351EUR System Power Cord, Europe Miscellaneous BL4351UK System Power Cord, United Kingdom Miscellaneous BL4351ITL System Power Cord, Italy Miscellaneous BL4351SWI System Power Cord, Switzerland Miscellaneous BL4351CHI System Power Cord, China Miscellaneous BL4352...

  • Page 191: Service And Warranty

    Service and Warranty...
  • Page 192 8 Service and Warranty 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. 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.

  • Page 193: Service Information

    • Customer account number • Name of function, handpiece, etc. that needs service • Model number (REF #) and serial number (SN#) of Stellaris Vision Enhancement System, located on the label on the back panel • Date of purchase •...
  • Page 194 8 Service and Warranty Returns To return a Stellaris Vision Enhancement System and /or 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: •...
  • Page 195 8 Service and Warranty Bausch & Lomb International Facilities * Indicates Global Product Support Numbers Argentina Bausch & 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 & Lomb Australia Pty, Ltd. & Surgical Level 4, 113 Wicks Rd.
  • Page 196 8 Service and Warranty 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 &...
  • Page 197 8 Service and Warranty France Bausch & 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 & Lomb France SAS (DistOps Offi ce) Tel: 33-4-37-48-83-83 Reception Fax: 33-4-37-48-83-84 Reception Germany Bausch &...
  • Page 198 8 Service and Warranty India Bausch & 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 & Lomb (Indonesia) c/o address in Singapore, see Singapore Italy Bausch &...
  • Page 199 8 Service and Warranty Malaysia Bausch & Lomb Malaysia Sdn Bhd 3rd Floor, Bangunan THK, Lot 2A Jalan 243/51A, 46100 Petaling Jaya Selangor Darul Ehsan, Malaysia *Tel: 60-3-7680-8828 *Fax: 60-3-7680-8871 Mexico Bausch & Lomb Mexico S.A.de C.V. Av. Santa Fe # 505, Piso 6 Colonia Cruz Manca, Santa Fe Delegacion Cuajimalpa Mexico D.F.
  • Page 200 8 Service and Warranty Portugal Bausch & Lomb S.A. (Sucursal Portugal) Avenida do Forte N°3 Edifi cio Suecia IV Piso O Esq. 2795-504 Carnaxide Lisbon, Portugal *Tel: 351-214-24-1510 *Fax: 351-214-24-1519 Singapore Bausch & Lomb (S) Pte. Ltd. 151 Lorong Chuan # 04-03A New Tech Park, Lobby C Singapore 556741 *Tel: (65) 68349112...
  • Page 201 8 Service and Warranty Sweden (Denmark, Finland, Norway and Sweden) Bausch & Lomb Nordic AB Söder Mälarstrand, 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 & Lomb Swiss AG Dammstrasse 19 6301 Zug, Swiss Tel: 0848-228726 Taiwan...
  • Page 202 8 Service and Warranty United Kingdom Bausch & Lomb U.K., Ltd. 106-114 London Road Kingston-upon-Thames Surrey KT2 6TN, England Tel:44-20-8781-2900 Fax: 44-20-8781-2901 *Tel: 44-208-781-0000 *Fax: 44-208-781-0001 Europe, Middle East & African Division European Headquarters Vietnam c/o address is Singapore, see Singapore 110017243EN Rev.

  • Page 203: Environmental Protection

    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 fl uids during the surgical process. These should be handled and disposed of in accordance with current biomedical procedures.

  • Page 204: Warranty Information

    (d) the Stellaris Vision Enhancement System has been altered, neglected, abused or misused, (e) the Stellaris 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 &...
  • Page 205 8 Service and Warranty 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 specifi ed on your sales tender or contract.
  • Page 206 8 Service and Warranty 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 &...
  • Page 207 8 Service and Warranty 8-16 Operator’s Manual 110017243EN Rev. G...

  • Page 208: Specifications

    Specifications...

  • Page 209: Environmental And Physical Specifications

    9 Specifi cations Specifications 9.1. Environmental and Physical Specifications Note: This device contains items which may be classifi ed as waste electrical or electronic equipment. Please dispose of the equipment according to local requirements. 110017243EN Rev. G Operator’s Manual 9-1...
  • Page 210 9 Specifi cations Environmental Specifications Parameter Specifi cations 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°...
  • Page 211 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 confi guration in which it will be used.
  • Page 212 BL4394 Foot Control Backup Cable 144” Guidance and Manufacturer’s declaration – electromagnetic emissions The Stellaris Vision Enhancement System is intended for use in the electromagnetic environment specifi ed below. The customer or the user should assure that it is used in such an environment.
  • Page 213 9 Specifi cations Guidance and Manufacturer’s declaration – electromagnetic immunity The Stellaris Vision Enhancement System is intended for use in the electromagnetic environment specifi ed below. The customer or the user should assure that it is used in such an environment.
  • Page 214 If the measured fi eld strength in the location in which the Stellaris Vision Enhancement System is used exceeds the applicable RF compliance level above, the Stellaris 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 Vision Enhancement System.
  • Page 215 Stellaris Vision Enhancement System and the 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...

  • Page 216: Primary System Specifications

    9 Specifi cations 9.2. Primary System Specifications Computer Unit Specifications Parameter Specifi cation Display Technology: Flat Panel, Liquid crystal display (TFT LCD) full color Size: 18.1” diagonal Pixels: 1280 x 1024 Physical Adjustment: Tilt: +15° up and -10° down Display Assembly Swivel: 90°...
  • Page 217 9 Specifi cations Foot Control Specifications Parameter Specifi cation External components and housing are corrosion resistant Watertight housing Wireless control (10m standard range) Corded, low voltage connection to system Non-skid base General 4 gray colored function switches Wall Charger 3.6v battery (lithium) Battery charging cradle Physical 12.22 cm, 4.8125 in.(H)
  • Page 218 9 Specifi cations Remote Control Unit Specifications Parameter Specifi cation Wireless pointing device providing line of sight operation using an IR transmitter Provides operation up to 15 feet from display console Powered from standard AA battery General (batteries) Low battery indicator Transmit indicator Splash-proof Illuminated keys...
  • Page 219 9 Specifi cations Coagulation Function Specifications Parameter Specifi cation Single, Floating BF Connection Connector Coaxial connector Coagulation Connections United States—Banana Jack Cord, Banana Jack Cords to Coaxial adapter International—Reusable Coaxial Cord Modes of Operation Linear Mode, Fixed Mode Output Range: 7.5 Watts Nominal @ 100 ohms Frequency: 1 MHz nominal Maximum Peak Open Circuit Voltage = 120V Linear Mode...
  • Page 220 9 Specifi cations Ultrasound Function Specifications Parameter Specifi cation Ultrasound Time: System records and displays ultrasound time in 0.01 second increments Tuning: System provides one step tuning. Self Special Features adjusts to resonant frequency of handpiece Probe Present: System provides a probe present detection system Wave form ultrasound available Connection...
  • Page 221 9 Specifi cations Ultrasound Function Specifications Operating Parameter Specifi cation Maximum Power: 35 Watts @ approx. 900 ohms Frequency: 28.5 kHz nominal Range: 0% to 100% power in 1% increments Wave for Ultrasound: Disabled/Enabled (throughout) Continuous Ultrasound Mode Control: Linear power control via the footpedal Nominal phaco handpiece tip stroke at 100% power setting with DP8130 Microfl ow needle is 130 μm at 28.5 kHz.
  • Page 222 9 Specifi cations High Speed Vitrectomy Function Specifications Parameter Specifi cation Single fl oating BF Connection Output Power: 2.8 Watts @ approx. 10 ohms Frequency: DC Linear Cut Range: 600 to 1500 cuts per minute Rate Mode Vitrectomy Control: Linear control of cut rate via the Foot Operating Control Parameters...
  • Page 223 9 Specifi cations Advanced Flow Function Specifications Parameter Specifi cation General Programmable vacuum response Flow Mode • Fixed fl ow fi xed vacuum limit • Fixed fl ow linear vacuum limit • Linear fl ow fi xed vacuum limit Modes of Operation •...
  • Page 224 9 Specifi cations Pressurized Infusion Specifications Parameter Specifi cation Atmospheric air with 0.1 micron Input hydrophobic fi lter Pressurized Infusion 100mmHg maximum air pressure, fl ow rates up to 6.5 standard cubic Pressure feet per hour Range: 1-100mmHg Control: 1 mmHg increment 9-16 Operator’s Manual 110017243EN Rev.
  • Page 225 9 Specifi cations System Labels Main System Label Foot Control Label Large Remote Control Label Small Remote Control Label System Power and Fuse Label Foot Control Foot Control Battery Label Battery Door Label 110017243EN Rev. G Operator’s Manual 9-17...
  • Page 226 9 Specifi cations 9-18 Operator’s Manual 110017243EN Rev. G...
  • Page 227 Accessories 7-20 Actual Phaco Time (APT) 4-17 Advanced Flow Fluidics 4-9 Agency Certifi cations 9-3 APT (Actual Phaco Time) 4-17 Aspiration Handpiece Cleaning 5-5 Sterilization 5-7 Operation 4-7 Aspiration see also I/A Vitrectomy Module Aspiration Setup, Vacuum Fluidics 4-11 Aspiration, Ultrasound 4-21 Assistance 8-2 Audio Tab 2-11 AVE (Average Ultrasound Power) 4-17...
  • Page 228 Setup Fixed 4-25 Linear 4-26 Function Description 1-13 Specifi cations 9-14 Coagulation More 2-9 Computer Unit Operation 4-1 Specifi cations 9-10 Connections Electrical 6-3 Customize Exception 3-8 Date, Format 3-18 Date, Setting 3-18 DC (Duty Cycle) 2-8, 2-15, 4-17 Delete Settings File 3-17 Description Function 1-13 IV Pole 4-5...
  • Page 229 Foot Control 6-4 Battery Charging 2-21 Description 1-13, 2-17 Functions 2-23 Linear Control 2-26 Operation Aspiration 4-8 Irrigation 4-8 Ultrasound 4-17 Vitrectomy 4-16 Specifi cations 9-11 Footpedal 2-25 Footpedal More 2-10, 2-24 Footpedal Status 2-16 Fuse Replacement 7-1 Handpiece Cleaning Bipolar Accessories 5-3 For U.K.
  • Page 230 Keyboard 2-4 Language 2-12, 3-5, 3-13, 3-18 Layout, Screen 2-14 Level 1 Display 2-14 Level 2 Display 2-16 Maximum IV Pole Height 3-30, 4-5 Menu, Clock 2-14 MMC (MultiMedia Center) 1-15 Module Coagulation see also Coagulation Module Computer Unit see also Computer Unit IV Pole see also IV Pole Ultrasound see also Ultrasound Module Phaco...
  • Page 231 Burst 4-17 Linear 4-19 Pulse 4-17 Turning on System 1-4 Viscoelastic Removal 4-8, 4-9 Vitrectomy Cutter Modes 4-13 General 4-10 Yaw Aspiration 4-20 Option List 2-2 PD (Pulse Duration) 4-17 Phaco (Phacoemulsifi cation cation) 4-17 PI (Pulse Interval) 4-17 Pneumatic Vitrectomy Cutter 4-13 PPS (Pulses Per Second) 2-8, 2-15, 4-17 Pressurized Infusion 2-7, 2-15, 3-8, 3-30, 3-31, 4-7, 4-27, 4-28, 7-17, 7-23 Pulse Duration (PD) 4-17...
  • Page 232 Advanced Flow 9-17 Cables 9-6 Coagulation 9-14 Computer Unit 9-10 EMI 9-7 Environmental 9-1, 9-2 Foot Control 9-11 High Speed Vitrectomy 9-16 I/A Vitrectomy 9-16 IV Pole 9-13 MMC 9-2 Physical 9-2 Remote Control 9-12 Ultrasound 9-15 Vacuum Fluidics 9-16 Spin Button 2-1 Sterilization Bipolar Accessories 5-3...
  • Page 233 Operation Burst 4-17, 4-20 Linear 4-19 Pulse 4-17 Phacoemulsifi cation Module Description 1-13 Specifi cations 9-15 Operation Burst 4-17, 4-20 Linear 4-19 Pulse 4-17 Power 4-17 Ultrasound More Settings 2-8 Ultrasound (U/S) see also U/S Unpacking 6-2 Unplanned Vitrectomy Setup, Vacuum Fluidics 4-15 U/S (Ultrasound) 1-13 Vacuum Fluidics Function 4-7 Vacuum Fluidics, Unplanned Vitrectomy Setup 4-15...
  • Page 234 110017243EN Rev. G...
  • Page 235 © Bausch & Lomb Incorporated. No part of this publication may be copied, photocopied, reproduced, translated, or reduced to any electronic medium or machine readable form, in whole or in part, without the prior written consent of Bausch & Lomb Incorporated, Rochester, NY 14609 USA. ™/® denote trademarks of Bausch & Lomb Incorporated. All other products/brands are trademarks of their respective owners. Manufacturing site: Bausch &...

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