Stellaris Operators Manual Rev E

Preface Indications for Use

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. Use only Bausch & Lomb approved disposable packs and Bausch & Lomb handpieces designated for use with this system. Safety may be degraded if accessories not meant for the system are connected.

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: 5,242,404; 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; 5,970,457; 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 and 7,168,930; additional patents pending. Foreign and other patents may also apply.

Trademarks

Bausch & Lomb®, Stellaris™, TruLink™, Storz®, and SuperSorb™ are trademarks of Bausch & Lomb Incorporated. The Bluetooth® word mark and logos are owned by the Bluetooth SIG, Inc. Other brands and product names used in this manual are trademarks of their respective owners.

Power Outputs COAG

BF

U/S

HIGH SPEED VITRECTOMY

BF

BF

7.5 W

35 W

2.8 W

100 Ω

900 Ω

10 Ω

1 MHz

28.5 kHz

DC

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Preface Manual Concept

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. Chapters 6 through 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 surgical procedures is a suggestion only, and does not constitute any warranty of fitness or claim of responsibility, or undertaking of liability resulting from any surgical techniques practiced. The physician is ultimately responsible for determining the appropriate procedure for each patient.

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.

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Preface Symbols and Notes

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.

CAUTION: 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.

Note:

Calls attention to an operating procedure, practice, or condition providing essential information.

Consult operating instructions.

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Preface Symbol and Notes

Direct Current

Alternating Current

Equipotential Ground

Foot Control

Remote Control Reception Indicator (Foot Control On/TruLink Access)

Battery

Dispose of Properly

Battery Condition Indicator

Serial Number

Manufacturer

Authorised Representative in the European Community

Date of Manufacture

Non Ionizing Electromagnetic Radiation

Caution: Consult Accompanying Documents

Frequency in Hertz

Type BF Applied Part

Fuse

Coagulation

or

Camera Recorder High Speed Vitrectomy Ethernet or

Pneumatic Vitrectomy

or

Ultrasound

Monitor

Stellaris Vision Enhancement System

USB

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Ω VA A

Ohms Volt Amps Amperes

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1 Getting Started System Description ... 1-2 Setting Up Your System ... 1-3 System Components ... 1-10

2 User Interface Basic Interface Controls ... 2-1 Surgical “More Screens” ... 2-6 Surgical Screen Layout ... 2-14 Foot Control ... 2-17

3 Customizing Your System Manage Settings ... 3-3 System Setup ... 3-18 System Configuration ... 3-21 System Calendar ... 3-22 TruLink Remote Access ... 3-23 Customization Levels ... 3-25

4 Detailed Reference Computer Unit ... 4-1 System Console ... 4-2 IV Pole ... 4-5 Remote Control ... 4-6 Advanced Vacuum System Fluidics ... 4-7 Advanced Flow System Fluidics ... 4-14 Ultrasound Function ... 4-16 Coagulation Function ... 4-23

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5 Cleaning and Sterilization Requirements Stellaris Vision Enhancement System Routine Cleaning ... 5-2 Bipolar Coagulation Accessories ... 5-3 Advanced Flow Fluidics Transducer ... 5-4 Irrigation and Irrigation/Aspiration Handpieces ... 5-5 Phacoemulsification Handpiece and Accessories ... 5-8 High Speed Vitrectomy Handpieces ... 5-12 Special Instructions for United Kingdom Users ... 5-13 Cleaning the MMC ... 5-15

6 Setup Setup Instructions ... 6-2 Connections and Setup ... 6-3 Multimedia Center (MMC) (optional accessory) ... 6-5

7 Troubleshooting and Maintenance User Troubleshooting ... 7-1 Power Issues ... 7-1 Error and Warning Messages ... 7-3 Troubleshooting the MMC ... 7-18 Accessories and Packs ... 7-20

8 Service and Warranty Service Information ... 8-2 Environmental Protection ... 8-12 Warranty Information ... 8-13

9 Specifications Environmental and Physical Specifications ... 9-1 Primary System Specifications ... 9-10

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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 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.

WARNING: Electromagnetic interaction between the phacoemulsification (phaco) handpiece and an implanted cardiac pacemaker is unlikely, but cannot be ruled out. Patients should be questioned to determine if they have such an implant and, if so, the manufacturer of the implant should be consulted to determine the proper course of action.

WARNING: Patient not to come in contact with earthing metal parts.

WARNING: Avoid skin-to-skin contact.

WARNING: Grounding reliability can only be achieved when the equipment is connected to an equivalent receptacle marked “Hospital Only” or “Hospital Grade.”

WARNING: The power supply’s UPS battery is not intended to be changed by the operator. Contact your Bausch & Lomb representative if the battery needs to be changed.

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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.

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

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1.2. Setting Up Your System

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.

WARNING: Do not manually force the IV Pole downward if the system is on. Unlock the display screen by removing the work surface pad, aligning the upright screen so that it faces forward, and loosening the lock-down screw that resides underneath the pad. Afterward, replace the pad.

Work Surface Pad

Lock Down Screw

Before the first use of the Stellaris Vision Enhancement System, connect the Foot Control as described on page 6-4. The following pages contain an overview for setup and use of your Stellaris Vision Enhancement System in a typical cataract surgery. This information is intended for use by someone who is already familiar with this type of system.

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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 Screen Drape

Remote Control Drape

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.

CAUTION: Do not turn this switch off until the system has been properly powered down.

CAUTION: Do not disconnect system from power while in use.

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Fuse Holder

Power Cord Retention Clip

Power Cord Input

Main Power Switch

Ethernet Port

Foot Control Backup Cable Port

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 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. Only after the Foot Control has been synchronized to the specific Stellaris Vision Enhancement System (see 6-4), may you use wireless communication. If you are going to use the Foot Control in wireless mode, ensure the Foot Control battery is charged, then hold down any button on the Foot Control until the green ready light comes on, indicating that communication has been initiated. This light will turn solid green when full communications have been established. When the system check is completed following system power-up, the Select Surgeon screen will appear.

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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.

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To Start a New Procedure 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. On-screen instructions take precedence over information in this manual. 1. Setup Fluid Collection System Open disposables pack and connect fluid collection system. • If using a vacuum system, firmly insert the fluidics cassette until it is automatically captured by the system. • If using 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. 2. 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.

Note: If a linear coagulation in setup is enabled or a Foot Control button is programmed for coagulation, begin by plugging in the coagulation cord. a. Spike the BSS bottle and hang it from the IV Pole. b. 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 lighted solid. c. Attach the ultrasound handpiece needle. d. Attach the irrigation sleeve. e. 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.

WARNING: The animations illustrate the steps but do not represent sterile technique.

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Advance to Surgery Phase 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 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.

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.

Note: Make sure to close the Irrigation Clamp on the Administration Tube Set before ending 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.

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The Stellaris Vision Enhancement System will ask if you want to save any changes you have made to surgical parameters. If you say yes, you can save the changes over your existing surgeon preference file, or save the new settings in a new surgeon preference file. 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.

CAUTION: Never turn the power switch off or disconnect the power without proper system shutdown. Equipment damage can occur. 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 2-21.

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1.3. 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.

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 the manufacturer of the pacemaker should be consulted to determine appropriate steps to take in order to use the bipolar cautery function.

User Interface Screen 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. 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.

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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. 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 and a uninterrupted power supply (UPS). For new systems left idle more than seven days, or for which the UPS has recently been used, charge UPS for four hours to ensure proper operations. UPS maintains system in low power mode for 60 seconds in the event main power supply is interrupted.

CAUTION: To prevent loss of data, save data before system shuts down. 110017243EN Rev. E

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USB Port Access

Screen Rotation Lock Cover

Port Not Used

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.

High-Speed Vitrectomy Cutter The top port is for an optional high speed electric vitrectomy cutter.

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Ultrasound Function (Phacoemulsification)

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 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 procedures 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 4-23 for details of use and page 9-14 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 2-17 for detailed instructions for its use.

Fluidics Function Each Stellaris 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 mm Hg. 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 0 to 800 cpm. See page 4-14 for details and Chapter 9 for technical specifications.

Advanced Vacuum Function This function uses a vacuum-based pump to control the output vacuum range from 0 to 600 mmHg, and uses a rigid 300 ml collection cassette with irrigation and aspiration tubing. Pneumatic vitrectomy supports both a Linear Cut Rate and a Fixed Cut Rate from 0 to 800 cpm. See page 4-7 for details and Chapter 9 for technical specifications.

Air Compressor The compressor module provides vacuum for aspiration in Advanced Vacuum systems, and air pressure to drive various pinch valves. See Chapter 9 for technical specifications.

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