Bausch & Lomb Stellaris Phaco Machine - User Manual PDF

Operators Manual
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. / are trademarks of Bausch & Lomb Incorporated or its affiliates. All other brand/product names are trademarks of their respective owners.
Bausch & Lomb Incorporated Manufacturing site:

One Bausch & Lomb Place Bausch & Lomb Incorporated Bausch & Lomb Incorporated
Rochester, NY 14609 USA 106 London Road, Kingston upon Thames, KT2 6TN, UK 3365 Tree Court Industrial Blvd., St. Louis, MO 63122 110017243EN Rev. H BL3153EN
Preface
Indications for Use

The Bausch+Lomb Stellaris Vision Enhancement System is designed for use in anterior segment surgeries.
It provides capabilities for phacoemulsification, irrigation/aspiration, bipolar coagulation, and vitrectomy
operations.
WARNING: Use only Bausch + Lomb approved disposable packs, tubing sets and Bausch + Lomb
handpieces designated for use with this system Safety may be degraded if accessories not
meant for the system are connected.
User Profile
The Bausch+Lomb Stellaris Vision Enhancement System is intended for use only by qualified physicians
and nurses.
Contraindications
Use of accessories not designated by Bausch+Lomb for use with this equipment may result in serious
permanent patient injury, adverse surgical outcome, or damage to the equipment, which may not be covered
by warranty. See page1-1 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 safetys sake, please heed these precautions.
Patents
The Bausch+Lomb Stellaris Vision Enhancement System is covered by the following patents: 5,331,951;
5,370,602; 5,388,569; 5,406,503; 5,624,394; 5,795,328; 5,910,139; 5,964,746; 5,991,142; 6,045,527; 6,055,458;
6,077,272; 6,081,122; 6,083,195; 6,106,512; 6,203,516; 6,251,113; 7,168,930, 7,445,436 and 7,604,607;
additional patents pending. Foreign and other patents may also apply.
Trademarks
/ are trademarks of Bausch & Lomb Incorporated or its affiliates.
All other brand/product names are trademarks of their respective owners.
110017243EN Rev. H Preface-1

Preface
Power Outputs
COAG U/S
BF BF
7.5 W 35 W
100 900
1 MHz 28.5 kHz
Training
Following system installation at a surgical facility, Bausch+Lomb personnel will provide on-site training to
users who will operate the system. The training includes system startup, accessories and connections, priming
and settings adjustment consistent with the instructions provided in this user manual. Subsequent training is
provided for new staff, when the system is upgraded, or as requested by the facility.
Manual Concept
Bausch+Lomb designs manuals to give you the information you need when you need it, and we dont 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 Chapter2 to become familiar
with the Graphical User Interface and the Foot Control. These are your connections to operate the system.
Chapter3 describes information on how to customize the system to suit your particular needs. Chapter4 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. Chapter5 provides cleaning and sterilization information. These chapters
are meant to serve as a reference to questions of a more technical nature. Chapter6 through Chapter8 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.
Preface-2 110017243EN Rev. H

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.
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.
Caution or warning to consult accompanying documents to avoid patient or operator hazard.

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
Serial Number Manufacturer
Authorized Representative
Date of Manufacture
in the European Community
Non Ionizing
Caution: Consult
Electromagnetic
Accompanying Documents
Radiation
Frequency in Hertz Type BF Applied Part
Fuse Coagulation
or
Camera Recorder
Ethernet Pneumatic Vitrectomy

or
Monitor
Ultrasound
Stellaris
or
Vision Enhancement System.
Ohms
USB VA Volt Amps
A Amperes

Preface
21CFR801.109(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 page1-12.
Caution: Consult
Accompanying Documents

Preface

Table of Contents
1. Getting Started
1.1. System Description ................................................................................................................................ 1-2
1.2. Setting Up Your System .......................................................................................................................... 1-3
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. Surgical Screen Layout ......................................................................................................................... 2-14
2.4. Foot Control ......................................................................................................................................... 2-18
3. Customizing Your System

3.1. Manage Settings ..................................................................................................................................... 3-3
3.2. System Setup ........................................................................................................................................ 3-18
3.3. System Configuration ........................................................................................................................... 3-21
3.4. System Calendar ................................................................................................................................... 3-22
3.5. TruLink Remote Access .................................................................................................................... 3-23
3.6. Customization Levels ........................................................................................................................... 3-25
4. Detailed Reference
4.1. Computer Unit ........................................................................................................................................ 4-1
4.2. System Console ...................................................................................................................................... 4-2
4.3. IV Pole.................................................................................................................................................... 4-5
4.4. Remote Control ...................................................................................................................................... 4-6
4.5. Advanced Vacuum System Fluidics........................................................................................................ 4-7
4.6. Advanced Flow System Fluidics .......................................................................................................... 4-12
4.7. Irrigation/Aspiration Setup ................................................................................................................... 4-14
4.8. Vitrectomy Function ............................................................................................................................. 4-15
4.9. Ultrasound Function ............................................................................................................................. 4-20
4.10. Coagulation Function ........................................................................................................................... 4-27
4.11. DigiFlow Pressurized Infusion Function .......................................................................................... 4-30
110017243EN Rev. H
Table of Contents
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. Phacoemulsification Handpiece and Accessories ................................................................................... 5-8
5.6. Special Instructions for United Kingdom Users ................................................................................... 5-12
5.7. Cleaning the MMC ............................................................................................................................... 5-14
6. Setup
6.1. Setup Instructions ................................................................................................................................... 6-2
6.2. Connections and Setup ........................................................................................................................... 6-2
6.3. Multimedia Center (MMC) (optional accessory) ................................................................................... 6-3
7. Troubleshooting and Maintenance

7.1. User Troubleshooting ............................................................................................................................. 7-1
7.2. Power Issues ........................................................................................................................................... 7-1
7.3. Informational and Warning Messages .................................................................................................... 7-3
7.4. Troubleshooting the MMC ................................................................................................................... 7-19
7.5. System Configurations, Modules, Accessories and Packs .................................................................... 7-21
8. Service and Warranty

8.1. Service Information ................................................................................................................................ 8-2
8.2. Environmental Protection ..................................................................................................................... 8-12
8.3. Warranty Information ........................................................................................................................... 8-13
9. Specifications
9.1. Environmental and Physical Specifications ............................................................................................ 9-1
9.2. Primary System Specifications ............................................................................................................... 9-8
110017243EN Rev. H
1 Getting Started
Getting Started
This chapter is for people who have used this type of ophthalmic Vision Enhancement System before and want
to use the system without reading large portions of the manual.
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: To avoid risk of electric shock, this equipment must only be connected to a supply mains with
protective earth.
110017243EN Rev. H Operator's Manual 1-1

1 Getting Started
1.1. System Description

The Stellaris Vision Enhancement System has a modular design which enables it to be upgraded to take
advantage of advances in technology. The system consists of a main housing unit which contains a user interface
screen and the surgical modules, and a Foot Control, infrared remote control, handpieces, and other accessories.
Note: Do not use StellarisPC Vision Enhancement System posterior or combined packs on a Stellaris
system.
IV Pole
User Interface Screen
System Switch
ON/OFF
Pneumatic Anterior
Vit Acuator
Handpiece Connectors Expansion Space
Fluidic Module
Surgical Tray
Drawer
One-Touch Wheel Locking
1-2 Operator's Manual 110017243EN Rev. H

1 Getting Started
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.
Note: 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.
WARNING: Do not modify the pole height or manually force the pole height, as this could cause an
incorrect indication of the bottle height and patient injury.
WARNING: When using gravity infusion, the ophthalmic irrigation source shall be at or above the
patients eye level to avoid patient injury.
Before the first use of the Stellaris Vision Enhancement System, connect the Foot Control as described on
page6-3.
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.

1 Getting Started
Surgical Drape Setup

Attach the sterile screen drape by placing the drape over the top of the Stellaris Vision Enhancement System
screen and secure with the adhesive strip to top, not the front, of the display as shown in the illustration below.
Apply Screen Drape Here
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.

1 Getting Started
Figure1.1. Lower Rear of System.

1.Fuse Holder.
2.Main Power Switch, disconnects system from mains voltage. See IEC 60601-1, paragraph 8.6.7
3.Ethernet Port. 4.Foot Control Backup Cable Port.
5.Power Cord Input. 6.Power Cord Retention Clip. 7. Potential Equalization Connector.
Note: Turning off the Main Power Switch will disconnect the system from mains.
Press the power button on the front of the system, and wait for the screen to come on and the animation to
finish. The front power switch is brighter when the system is off, and dims when you turn the system on.
The Stellaris 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.

1 Getting Started
CAUTION: Observe system diagnostic messages when powering up system for first use each day and take
appropriate action if required. Also observe first cassette priming or calibration, phaco/frag
handpiece tuning and/or vitrectomy handpiece testing for correct completion.
Only after the Foot Control has been synchronized to the specific Stellaris Vision Enhancement System (see
page6-3), may you use wireless communication.
Note: The out-of-factory Wireless System Setup is Disabled. Software upgrade will also reset
the Wireless System Setup to Disabled. See System Setup Instructions (Chapter3) to
configure Foot Control to wireless operation.
If you are going to use the Foot Control in wireless mode, ensure the Foot Control battery is charged, then hold
down any button on the Foot Control until the green ready light comes on, indicating that communication has
been initiated. This light will turn solid green when full communications have been established.
When the system check is completed following system power-up, the Select Surgeon screen will appear.
Note: Following system shut down, wait a minimum of 15seconds before restarting the system. The
system is fully shut down after the front panel power button light changes from dim to bright.

1 Getting Started
Select Options
Touch the surgeons name on the list that appears, and it will be highlighted. Then select Confirm to load the
parameters for that surgeon and advance to the Setup Screen.
To setup a new surgeon instead of using an existing one, select Create New to setup a surgeon preference file
for a new surgeon, using parameters from an existing surgeon.
Setup Screen
The Setup Screen allows you to set certain procedure parameters, and prepare the system for surgical
procedures.
If desired, select Select Room and choose the case number, number of operating rooms being used by the
surgeon, and the particular operating room to be used.
If desired, select Select Case and choose the specific technique, needle, grade and pathology for the current
procedure.
Advance to open pack step by selecting Open Pack Insert Cassette from the clock menu.
Uninterruptible Operation of Your System

Some Stellaris models may have a 60-second memory back-up battery. This battery is not considered a
UPS (uninterruptible Power Supply) as it only sustains the software but is not sufficient to power surgical
functions. If the user of the Stellaris Vision Enhancement System requires continued operation during power
main interruptions, it is recommended that the Stellaris Vision Enhancement System be powered from an
uninterruptible power supply.
All new Stellaris systems and Power modules manufactured after November 2009 will cease to have memory
back-up battery function.
Note: In the event the power source is interrupted causing the system to shut down, remove handpiece
from the eye safely and pinch off irrigation clamp to stop fluid flowing into the cassette.
To Start a New Procedure
Note: 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. On-screen instructions take precedence over information in this manual.

1 Getting Started
Note: Ensure sufficient volume of irrigation solution is available for the procedure. The level should be
monitored during the procedure.
1. Setup Fluid Collection System

Open disposables pack and connect fluid collection system.
If using a vacuum system, insert the fluidics cassette all the way in and hold until it is
automatically captured by the system. The cassette housing backlight will stop blinking and turn
solid when the system captures the cassette.
For surgical techniques that uses high vacuum settings please use vacuum-based packs containing
the StableChamber tubing to increase holdability (higher vacuum levels) while maintaining
followability (controlled flow).
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.

1 Getting Started
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 Balanced Salt Solution bottle and hang it at the desired bottle height.
Additional step if pressurized infusion is used: Connect the Air Tubing Line (D4600A) to the vent
port at the bottle spike and the other end with air filter to the Stellaris air output connector.
Switch on the air pump from the system setup screen, the control is at the upper right hand of the
screen. The output connector will remain lit when it is at commanded pressure, and blink on and
off when it is not at the commanded pressure.
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 solidly lit.
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.

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 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 page2-6).
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.

1 Getting Started
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.
If you have the TruLink option enabled and have selected Shut Down System you will be asked to confirm
the system shutdown. The system will then ask if you want to upload system data to the Enterprise Server.
Ensure the Ethernet cable from the port at the bottom of the Stellaris Vision Enhancement System to the
hospital network port is connected before attempting to upload data. The system will send diagnostic data (no
patient data is transferred), then shut down when complete.
At the end of the surgical day, make sure to recharge the Foot Control, as described on page2-27.

1 Getting Started
1.3. Moving Your System to Another Location
WARNING: Do not transport or move your system from room to room or up an inclination unless you
have followed the steps below.
This unit is designed to provide mobility within the environment of the operating room.
Care must be taken as to avoid sloped floors greater than 5degrees angle during use.
Before transporting the unit from room to room or for any more extensive moving, follow the basic safety
instructions:
If you want to move your system to another location, follow the steps as listed below.
1. Power down normally by selecting Shut Down from the end of case
screen or pressing and holding the front button for at least 8seconds,
ensuring the IV pole is fully retracted.
2. Remove any objects from mat on top of unit.
3. Store the tray all the way in the units tray receptacle.
4. Fully close the front drawer.
5. Roll the power cord in its proper hooks at the rear end of the unit.
6. Place the Foot Control on its dedicated hook, at the rear end of unit.
7. Remove the bottles and tube sets from the units pole hanger and store
separately from the unit.
8. Make sure no objects such as air hose, electrical cord, video cables,
etc... lie in the moving path.
9. Disengage the front brake lever.
10. Always maneuver the unit using the handle bar designed for this
purpose.
Your system is now ready to be moved to a new location.
Note: Do not store anything on top of the system, and do not pull the system by the IV pole.

1 Getting Started
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.
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.
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 page2-1
for details. Technical specifications can be found in Chapter9.

1 Getting Started
Stellaris Vision Enhancement System Console
IV Pole
System Switch
ON/OFF
Pneumatic Anterior
Vit Acuator
Fluidic Module
Surgical Tray
Drawer
This is the main unit (see page4-2), 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.
CAUTION: To prevent loss of data, save data before system shuts down.

1 Getting Started
USB Port Access
Air Pressure
Output Connector IV Pole Control Buttons
Cord Wrap Hooks
Foot Control Hook
Ultrasound Module
This module contains five ports for connecting system accessories. The top three ports are active and the bottom
two are reserved for future use.
Ultrasound Function (Phacoemulsification)
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

1 Getting Started
cannot be ruled out. Patients should be questioned to determine if they have such an implant
and, if so, the manufacturer should be consulted to determine the proper course of action.
The second port is for ultrasound handpieces. These support phacoemulsification 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 page4-27 for details of use and page9-12 for technical specifications.
Foot Control
The Foot Control contains the Footpedal and four programmable buttons, and provides the main interface
between the user and the Vision Enhancement System for controlling most functions. The Foot Control can be
used in a wired or wireless mode. Specifications are in Chapter9. See page2-18 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 1ml/min to 60ml/min, and vacuum levels
from 0 to 650mmHg. The corresponding pack has both irrigation and aspiration tubing and a 500ml fluid
collection bag which fits in a drawer on the front of the Stellaris Vision Enhancement System. Irrigation on/
off control is provided by an internal pinch valve. Pneumatic vitrectomy supports both a Linear Cut Rate and a
Fixed Cut Rate from 30 to 800 cpm. See page4-12 for details and Chapter9 for technical specifications.
Advanced Vacuum Function

This function uses a vacuum-based pump to control the output vacuum range from 0 to 600mmHg, and uses
a rigid 300ml collection cassette with irrigation and aspiration tubing. Pneumatic vitrectomy supports both a
Linear Cut Rate and a Fixed Cut Rate from 30 to 800 cpm. See page4-7 for details and Chapter9 for technical
specifications.

1 Getting Started
Air Compressor
The compressor module provides vacuum for aspiration in Advanced Vacuum systems, air pressure for
pressurized infusion and air pressure to drive various pinch valves. See Chapter9 for technical specifications.
Remote Control
The remote control allows control of various surgical functions from a distance. The receiver for the IR
signal is at the bottom of the computer screen. See page4-6 for details of operation and Chapter9 for technical
specifications.
TruLink Remote Access (optional)

The TruLink Customer Support Network feature improves system reliability by supporting remote diagnostics
and performance analysis. System performance data, but no patient data, is collected by the Stellaris Vision
Enhancement System throughout the surgical day. Upon system shut down, that information can be sent to
Bausch+Lomb secure servers through an encrypted, point to point connection. This allows Bausch+Lomb
to analyze system performance, help you remotely (where this service is available), and proactively service the
system. Surgeon preference files can also be transmitted, to provide a secure off-site backup.
The Ethernet cable that is used to transfer the data can be permanently connected to the Stellaris Vision
Enhancement System, or it can be connected at the end of each surgical day just before shutting down, and
then disconnected to move or store the Stellaris Vision Enhancement System. Upon shutdown, from the End
of Surgery screen, the system will prompt you if you would like to Send data to TruLink, if in agreement,
please make sure that the Ethernet cable is connected to the designated port of location and follow instructions.
After updating, the system will shut down automatically.

1 Getting Started
Multimedia Center (MMC) (optional)

The MMC is an optional accessory that provides streaming video on the surgical screen and microscope overlay
capability. The MMC supports NTSC and PAL format composite video and S-video, or a FireWire digital
camera.
Main Switch
Connectors from Stellaris
Connectors from TruLink
Connector Status
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. Whenever the MMC is on and connected and the Stellaris Vision Enhancement System
is in surgical mode, the current video image will appear on screen in the center of the Clock Menu. You can
touch the video image itself to toggle between small and large display sizes. You can also touch the outer
edge of the video display to toggle between the video display itself and an animation showing the effect of the
handpiece in the eye for the currently selected phase.
If the system has the optional MMC, the TruLink Remote Access can be activated by connecting the Ethernet
port on the MMC to a designated Internet-enabled network connection and enabling the Trulink data download
upon shutdown or Remote Access (if available in your area) function on the Stellaris Vision Enhancement
System.
Note: Off-the-shelf Ethernet cable may be used with the Stellaris Vision Enhancement System to
establish or restore connections.
Note: The MMC is not intended for diagnostic purposes.
Before installing the Multimedia Center, please take note of the following:
Multimedia Center must be installed outside of the sterile field.

Do not place Balanced Salt Solution bottle or other containers of fluid on top of the Multimedia Center.
AC power source for the Multimedia Center must have a Ground Fault Interrupt.

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. Pressing the displayed number will take you to the numeric keypad
(see page2-3) so you can enter an exact number only if the surgical function is not currently in use.
Push Bar
This is a single button control which displays a command, and initiates that action when you select it. No value
is associated with this control and holding it down performs no additional function.

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Option List
The Option List allows you to select an option. A small + next to a setting indicates that additional choices are
available, and selecting the currently displayed option will bring up a list. Only one option can be selected at a
given time. Selecting one option automatically deselects others.
Test Tube Display and Control

This type of control allows you to set the limits of a system parameter. The actual value is displayed above the
tube, and the allowable minimum and maximum values are shown beside the tube. The current setting may
be changed by selecting and dragging the slider ring. The slider ring may not be positioned below the current
setting minimum value. The minimum value may be changed with the surgical function More Screen.
Actual Value
Maximum Limit
Current Max Settings Slider Ring
Function Minimum

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Progress Bar
This graphic shows the progress of a procedure.
Numeric Keypad
Selecting a number on a spin control button brings up the numeric keypad. The keypad allows you to rapidly
enter numerical surgical settings or change settings. Numbers are entered by touching the numeral, then select
Enter to make the change. When a surgical function is active, the keypad for settings associated with that
function will be removed or disabled.

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Keyboard
Sometimes you will need to enter alphabetical or numeric data into the Stellaris Vision Enhancement System.
A keyboard similar to that shown below will appear, and you can touch the characters in order to enter them.
Selecting the back arrow will delete the last character typed, and selecting Clear will delete all characters.
Select Enter when you are done to save the entry and return to the previous screen or it will advance to next
level of programming screen.
Character Lengths
There is a finite number of characters that can be used for certain functions. Refer to the table below:
Function Maximum Characters

Mode 8
Technique 20
Submode 20
Pathology 20
Surgeon 30
Display Format
Selecting this button, shown below, steps that section of the display through multiple levels of complexity. It
appears on the Status Bar Window and the Ultrasound Submode List.

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Pop-Up Message Window

This type of window appears to display error and warning messages. You should take the appropriate action
before the system will continue. Nothing else can be done on the screen while a pop-up window is on the
screen. The surgeon may be able to continue with the procedure once the error has been rectified.*
* For each message displayed, suggested actions to resolve the condition are displayed. If more than one
suggested action is available, pressing the Next button will cycle through all possible suggested actions.

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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.
More Screens are available for the Fluidics (Aspiration and Infusion), Ultrasound, Coagulation, Vitrectomy,
Footpedal, and Audio/Visual functions, and Case Selection options.
Note: More Screens for the Fluidics, Ultrasound, Coagulation, and Vitrectomy functions are only
available at Display Level 2.

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Fluidics (Flow and Vacuum) More Screen

The Fluidics More Screen has two tabs, one for Aspiration settings and one for Infusion settings. Select either
tab at the top of the Fluidics More Screen to see options specific to the fluidics system installed on your
system. The specific options available will depend on what accessories you have on your system, the current
programming level, and other system settings.
The Aspiration Tab can show the current mode, vacuum settings, flow settings, vacuum response setting,
venting method, and Foot Control Mapping.
The Infusion Tab can show the current Infusion mode, IV Pole Height (actual, preset and maximum), Balanced
Salt Solution Container Type, Patient Eye Level, Irrigation Delay and Pressurized Infusion (enabled/disabled,
pressure settings, pump on/off status).
The actual IV Pole height is the current distance between the aspiration port and the mid-point of the viewing
port of the Balanced Salt Solution drip chamber. The maximum IV Pole height is the highest setting the IV Pole
will be allowed to reach, usually determined by the ceiling height and set at time of system installation. A zero
level bottle hanger (BL4363) is an optional accessory that allows the Balanced Salt Solution drip chamber to be
level with the aspiration port.

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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. You can adjust any of these settings.

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Coagulation More Settings

The Coagulation More Screen shows the current minimum and maximum power levels, and the Foot Control
Mapping mode. You can adjust either power level setting.
Vitrectomy More Settings

The Vitrectomy More Screen shows the current settings for the minimum and maximum CPM (cuts per
minute). You can adjust either setting. The current Foot Control Mapping is also shown.
Note: Foot Control mapping available on Programming Level2 and 3 only.

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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 page2-18).
The Settings Tab shows the current status of the Foot Control buttons, right or left foot operation, Dual Linear
Control, Mode Change Control, Next U/S (Ultrasound) Modulation on Yaw, Reflux Type, and Fixed Coag
Power. Editable functions are highlighted with a blue or gray background marked with +.
The Regions Tab shows the current settings for the footpedal pitch regions and detent options. You can modify
the starting depression position for each region.

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The Status Tab shows the current status of several footpedal options, including communication status, battery
status, and signal strength.
A/V More Screen

The A/V More Screen allows you to change many aspects of the audio and video display. Each tab allows you
to change the settings and configuration for aspects of the display.
The Audio Tab controls the master volume for the system, as well as the specific tone and volume used for
each of the following events: Irrigation, Vacuum, Occlusion, Ultrasound, Coagulation, Vitrectomy, and Alert.
The selected tone will be played when that function is active, and the frequency of the tone will change with the
value of the function.
Select the tone you want to change, then use the menu and arrows on the right side of the screen to select the
tone used for that condition, and the volume at which the tone will be played. Only tones not currently in use for
another condition will be displayed.
Voice Confirmation can also be enabled or disabled through this tab.

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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. By default, the U/S data is shown as three separate lines on the video
overlay. If the U/S combine option is set to Yes, the display will appear on one line, which will step through the
three values. Similarly, settings are normally displayed on four lines, and case information on two lines, but if
the combine option is set to Yes each will appear on one line that will step through the values.
Finally, you can set the video overlay overscan in one degree increments from 0% to 5%.

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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. Select the parameter to be changed, and then select
the new setting from the option list. When you have made all the desired changes, select Close and the change
will take effect.
You can select Save Settings to have the new settings overwrite the current surgeons preferences, and be stored
in the main preferences file.
Note: Selecting Save Settings here will save all changes made through any aspect of the user
interface. You can select Reset Averages to clear the average values and elapsed times for the
surgical functions for this case.

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2.3. Surgical Screen Layout
Note: Voice confirmation (if enabled) responds to Foot Control and remote operation and on-screen
buttons.
The main surgical screen can appear in one of two formats. The default format is set as a surgeon preference. To
switch between levels, click the A/V More Button (located at the top of the screen), select the Screen Display
Tab, then select the desired Display Format Level.
Level 1 Display
At Level 1, only the basic controls are displayed.
Note: More Screens for the Fluidics, Ultrasound, Coagulation, and Vitrectomy functions are only
available at Display Level 2.
Clock Menu
The round Clock Menu in the middle of the screen can display up to 12 phaseseight normal phases and four
exceptions. The exceptions appear on the left side of the clock menu, against a darker background. These are
user-defined to be any mode type (Irrigation only, Ultrasound, Irrigation/Aspiration, Electric Vit, Pneumatic Vit
or Coagulation). The Setup and End are the system function keys in the clock menu to change from surgical
display screen to Setup and End screens.

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If you have the optional MMC system installed, the center of the Clock Menu will show the video from the
microscope camera, when video is available. You can select the video itself to switch between small and large
video display formats. You can select the edge of the video to display an animation showing the effect of the
handpiece on the eye for the current surgical phase.
See Chapter3 for details on customizing your system.
IV Pole
The upper right corner of the screen also displays the current setting for the IV Pole (on the bottle), as well as
the preset value (above the bottle). You can use the up and down arrows to change the height, and the IV Pole
will automatically move up and down to match the setting.
The Preset value is a pre-programmed value to which you can jump quickly, simply by selecting it on the
screen. Different surgical modes may have different preset values. You can change the preset value for the
current session by opening the Fluidics More Screen (see page2-7) and selecting the Infusion Tab.
The On/Off button controls the continuous irrigation function, by opening or closing the irrigation pinch valve
in the fluidics system. If the irrigation control is turned off, the function will still be managed by the Foot
Control when the footpedal enters Region1, irrigation will commence.
Fill
Button
Selecting the fill button opens the pinch valves in the fluidics system for a fixed period of time. This function is
useful for filling surgical beakers without overflow. The button shows the current state of the fill system (On or
Off). You can select it to toggle to the other state.
Air Pressure
If Pressurized Infusion function is programmed in the surgeon file, the upper right corner of the screen displays
the current setting of air pressure when the pump is not running. When the pump is switched on, the same area
will display the actual output pressure. Below the setting display, there is an on/off button to control the air
pump operation.

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Ultrasound, Coagulation or Vitrectomy

The lower right corner displays either the Ultrasound, Coagulation or Vitrectomy status, depending on which
mode is currently selected from the clock menu. The current setting is shown in the large spin control, with a
green background for ultrasound, yellow background for vitrectomy, and purple background for coagulation.
The actual value is displayed in a small grey circle below the spin control.
When ultrasound is active, an option list control appears in the lower right corner, and selecting the small +
allows you to select from a list of preprogrammed ultrasound submodes. If you select pulsed ultrasound, the
pulse per second (PPS) and duty cycle (DC) spin controls appear if the display option button is selected.
Vacuum
The upper left section of the screen shows the maximum vacuum or vacuum limit setting in a spin control
button, with the current actual value shown below it.
Flow
The lower left corner of the screen shows the maximum flow setting, if enabled, with the current actual flow
value below it. The volume of fluid in the collection device is also displayed here.
Footpedal and Coagulation

The current footpedal status is displayed in the middle of the bottom of the screen. The current pitch region (1,
2, or 3) is shown, and the circles around the top indicate yaw position. The Footpedal More Button brings up
a More Screen that allows you to change settings on the footpedal. See page2-10 for details on changing these
settings. See note on page2-33.
If one of the Foot Control Buttons has been programmed to control coagulation, a small Coagulation spin
control will appear just to the left of the Foot Control display, showing the current maximum power setting for
the coagulation function.
Case Window
At the top of the screen, a status bar display shows the name of the surgeon currently working, as well as the
current case number. Selecting the Display Format Button (see page2-4) repeatedly shows progressively more
detail.

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Level 2 Display
At Level 2, more detailed information is added to each display about the current value of each system. In
addition to the spin control buttons that are present in the Level 1 display, the Level 2 display adds a test tube
display and control (see page2-2). The current value of the function is displayed at the top of the tube, and a slider
ring on the tube can be used to change the setting.

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.
This device complies with Part 15 of the FCC (U.S. Federal Communication Commission) Rules. Operation is
subject to the following two conditions: 1) this device may not cause harmful interference, and 2) this device
must accept any interference received, including interference that may cause undesired operation.
Placement of Foot Control During Storage

2 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 page2-27.
Foot Control Battery Installation Guide:
1. Place Foot Control upside down on a flat, dry surface.

2. Open battery door by pressing the targets on the door toward the battery compartment and turn the two
latches 90 degrees away from the center.
3. Remove battery with two fingers holding on to the battery.
4. Before installing the replacement battery, check battery electrical contacts to ensure they are clean and
free of contamination.
5. Install new battery.
6. Press the door toward the compartment and engage door latches to securely close battery door.
Battery compartment with recess (arrows) to

facilitate battery replacement
Note: Be sure to securely close battery door.
Note: A battery must be installed in the Foot Control at all times, while operating either wired or
wireless, to insure proper operation.
LED Symbol for Battery on Foot Control

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Note: The out-of-factory Wireless System Setup is Disabled. Software upgrade will also reset the
Wireless System Setup to Disabled.
To setup wireless operation, follow steps below:
1. Select Programming from Setup or Select Surgeon screens.

2. Select System Setup from the Programming screen (screen image below).
3. Select Foot Control tab from the System Setup screen (screen image below).
4. Select Wireless Enabled or Disabled to configure Foot Control connection mode.

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Note: The system setup is for enabling wireless functionality, it does not affect the wired functionality.
The wired option is always available and active when connected.
Note: System will disable wireless operation once it detects loss of wireless communication at
setup and surgery screens. Once wireless connectivity is lost, the wireless opperation must be
manually reconfigured using the system setup screens.
Note: The system will disable wireless operation when the battery is replaced or removed while system
is in surgical or setup screens. To configure system to wireless operation, see section on Wireless
Foot Control System Setup, page2-20.
The first time a Foot Control is used, it must be connected via the back up cable to set the configuration. Once
this is set, the Foot Control will only communicate wirelessly with that specific system. To begin wireless
operation, make sure the Stellaris Vision Enhancement System is on, then press any Foot Control Button and
wait up to ten seconds for communication to be established.
The ready light, identified by the symbol below, will turn solid green when the Foot Control is communicating
wirelessly with the Stellaris Vision Enhancement System. During operation when system is not detecting
Foot Control wireless connection; the system will disable wireless operation. This happens when the system
is in setup and surgery screens. To resume wireless operation, refer to the Foot Control Wireless System setup
section.
LED Symbol for Ready on Foot Control

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When not in use, the Foot Control can be stored on the back of the Stellaris Vision Enhancement System.
In some operating configurations the surgeon can change surgical phases using the Foot Control.
Back-Up Power Cord Input
Right Toe Button

Left Toe Button
Foot Pedal
Right Heel Button
Indicator Lights
Left Heel Button
Left LED (Battery) Right LED (Wireless)
Pedal Pitch Tension

Adjustment Knob
Pedal Offset
Adjusment Switch
Battery Compartment Door

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Foot Control Status and Wireless Signal Strength Meter Display

The status of Foot Control operation is represented by an icons display at the lower portion of the screen above
the foot pedal activation status indicator. Wired connectivity is represented with a cable icon and the wireless
connectivity is indicated with a signal strength meter icon. See table below:
Display Type Foot Control Setup Status Action

Wired System detecting wired No action required
(Wireless disabled) Foot Control
Wired System NOT detecting Check Foot Control cable

(Wireless disabled) wired connection. connection.
Possible cause: If Wireless System
Foot Control cable not Setup is on enabled,
connected wireless connection will
be activated momentarily
when system detects loss
of wired connection.
The wireless signal
strength icon will be
displayed indicating
system is now in wireless
operation.
Wireless System NOT detecting 1. Initiate wireless Foot
wireless connection Control connectivity
signal by pressing one of the
Possible cause: foot control buttons
1. Foot Control wireless momentarily, the left
function has not been LED will light up.
activated.
2. Check battery
2. Wireless connectivity if Foot Control
not functioning due to wireless function
battery issue not established after
Step1.

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Wireless System detecting No action required
Excellent signal strength
Wireless System detecting Good No action required

signal strength
Wireless System detecting No action required

Moderate signal strength
Wireless System detecting Low No action required

signal strength

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Wireless (System System lost wireless Connect Foot Control
disabled wireless setup) connection signal during backup cable to resume
procedure. operation.
System will automatically
configure to wired Note:
operation. System will remain in
The icon remains wired configuration
until connected with the next time system is
Foot Control cable or powered up. To configure
manually re-configures system to wireless
system to wireless operation, see section on
configuration. Wireless Foot Control
System Setup, page2-20.
Note: The system will disable wireless operation when the battery is replaced or removed while system
is in surgical or setup screens. To configure system to wireless operation, see section on Wireless
Foot Control System Setup, page2-20.
Note: Irrigation will be turned ON and other functions will be disabled when the system does not
detect Foot Control connectivity in surgical mode. Irrigation can be turned OFF from the touch
screen.

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Battery Management
This symbol on the battery indicates that the product must be disposed of separately and
safely. Therefore, it is your responsibility to dispose of this waste equipment by handing
it over to a designated collection point or organization that specializes in the recycling of
waste electrical and electronic equipment. The separate collection and recycling of your
waste equipment at the time of disposal will help conserve natural resources and ensure
that it is recycled in a manner that protects human health and the environment. For more
information about where you can drop off your waste equipment for recycling, please
contact your local recycling office or electronic waste hauler.
CAUTION: Do not expose the battery to any fluids.
The battery, when fully charged, will last for 12hours. You may rely on a single battery, or choose to keep one
charging in a battery charging cradle (BL4393 shown below) while the other battery is being used.

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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 its stored.
Note: Use only Bausch+Lomb supplied wall chargers (BL4391), charging cradles (BL4393),
adapters (BL4392US, BL4392UK, BL4392EU, BL4392AUS, BL4392ROW), and batteries
(BL4390) with the Stellaris Vision Enhancement System.
The Foot Control Battery should be charged whenever the system is not in use. Any one of three methods can
be used to charge the battery.
With the system power cord plugged in to the electric source and the Foot Control connected to the
system; the battery will be charged if the main power switch is turned ON. This charging method
applies with or without the Graphical User Interface being turned ON.
The Foot Control can be directly connected to the wall charger. Connect the wall charger cable into the
back of the Foot Control, into the same receptacle used for the backup cable.
With an extra battery and battery charging cradle, you can connect the wall charger cable to the battery
charging cradle. A green light indicates the cradle is on, a second light is yellow when charging is in
progress, and green when the battery charging is complete. Once the battery is fully charged, you can
take it out of the cradle and replace the battery in the Foot Control.
Note: When the Foot Control is connected to the wall charger it will not communicate with the system
and cannot be used in surgery.
Note: To connect backup cable or wall charger to Foot Control, align red dot of the connectors to 12
oclock position.

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Note: The Foot Control is only to be used with wall charger BL4391.
Note: The battery charging cradle MUST be connected to the wall charger to charge the battery.
The wireless communication is disabled when the backup cable is in place.
The Stellaris 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 Chapter8 for a list of
local Bausch+Lomb offices.

2 User Interface
Foot Control Operation

The Foot Control has four buttons and a center footpedal which has two axes of movement, to control two linear
functions simultaneously. The footpedal operates with both the pitch (up and down) and yaw (side to side)
travel. The yaw movement simulates the side switches used on some systems, and can be set and programmed
for left-foot or right-foot users. Reflux (if selected) is always activated by inward yaw displacement. The center
footpedal may be programmed to operate two linear functions simultaneously (Dual Linear control). The control
of linear functions is proportional to the amount of footpedal travel. See page2-33 for description of linear control.
In single linear mode, pitch controls the linear functions selected, and yaw movement provides on/off control
in both directions. In Dual Linear mode, one linear function is controlled by pitch travel, and the other linear
function is controlled by yaw travel. The table on page2-34 shows the possible combinations of linear control.
Left Toe Button Foot Pedal
Right Toe Button
Left Heel Button
Left LED Right LED

(Battery) Right Heel Button
(Wireless)
There are two lights on the Foot Control itself. The light on the right indicates that the wireless connection on
the Foot Control is active. This light will flash until communications are established with the system. When the
light is non-flashing green, the Foot Control is ready to be used wirelessly. The light on the left indicates battery
status, as described in the table below.
Color Status
Green More than one hour of battery life remains
Yellow Battery is charging
Red and Blinking Less than one hour of battery life remains

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Basic Button Operation
Note: Voice confirmation (if enabled) responds to Foot Control and remote control operation. For
surgical phase changes, voice confirmation also will be activated if changes are made through
the touch screen.
All four buttons on the Foot Control are user programmable. They are initially set in the surgeon preferences
file, and can be modified either through the programming interface (see Chapter3), or in some cases through the
Footpedal More Screen (see page2-10).
The Footpedal More Screen is used to convey the current footpedal configuration and status to the surgical
team. It is displayed by selecting the Footpedal More Button, which is the below the Footpedal status icon on
the bottom of the Main Surgical Screen.
Footpedal
The footpedal itself, located in the center of the Foot Control, provides two axes of movement and thus allows
simultaneous control of two system parameters. Both controls are programmable with respect to function and
control parameters. In the pitch direction, the footpedal will provide approximately 15 of up/down movement.
In the yaw direction, the center pedal will provide approximately 10 of travel from center in both the left and
right directions, however, the center (home) position may be set to be offset approximately 5 in either direction
as explained on page2-33. When released, the footpedal will return to the home (up or center) position. The table
on page2-34 shows the possible combinations of control available. The programmable detents provide tactile
feedback to the pitch movement when it moves between different regions.

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Single Region Pitch Control (one detent position)

The pitch movement is programmed to provide linear control as a function of relative footpedal displacement
(e.g., 0 to 15 down corresponds to 0% to 100% output). An example of single region pitch control is the linear
coagulation function.
Two Region Pitch Control

There are two programmable regions (two detent positions). When programmed for linear control, the pitch
movement is a function of relative footpedal displacement in Region2 (e.g., 5 to 15 down corresponds to 0%
to 100% output). An example is I/A control, where Region1 is for irrigation, and Region2 is for linear vacuum
or flow.
Three Region Pitch Control

There are three programmable regions (three detent positions). When programmed for linear control, pitch
movement is a function of relative footpedal displacement as shown below. An example is single linear
ultrasound phases, where Region1 is irrigation, Region2 is fixed aspiration, and Region3 is linear ultrasound
power.

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Programmable Yaw Positions

The Foot Control may be set and programmed to give greater linear yaw movement for either right or left
foot operation. Turn the Foot Control over and adjust the Pedal Offset Switch to the left or right for preferred
direction.
Set and programmed for a right footed operator with the pedal home position offset to the left of center
by approximately 5 to give approximately 15 of motion to the right and approximately 5 of motion
to the left. See Dual Linear Yaw Control below.
Set and programmed for a left footed operator with the pedal home position offset to the right of center
by approximately 5 to give approximately 15 of motion to the left and approximately 5 of motion to
the right. See Dual Linear Yaw Control below.
Set and programmed for a right- or left-footed operator with the home position in the center giving
approximately 10 of motion in both directions.
Pedal offset switch indicator must align with either left, right or center pedal offset position.
Failure to align the indicator appropriately will cause the Foot Control to become inoperable.
Left or right offset position selections strictly follow system software programming for Left or
Right foot operations. E.g.: If system is programmed to right foot operation, the indicator (4)
can only be set to Center (6) or Right Offset Position (7) only. Refer to diagram below.
Pedal Offset Switch Indicator
Pedeal Offset Position- Pedeal Offset Position- Pedeal Offset Position-

Left Center Right
(for system setup (for system setup (for system setup
for left foot operation) for left or right foot) for right foot operation)

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Single Linear Setup

In Vitrectomy Mode, the outward yaw movement provides ON/OFF cutting control. Each successive outward
movement toggles the programmed tool ON or OFF. In ultrasound mode, outward yaw control could be
programmed to toggle between different ultrasound submodes. When the footpedal is released, it returns to the
center position. Inward yaw movement controls reflux.
Dual Linear Setup

The outward yaw movement provides linear control of the programmed function, relative to footpedal
displacement (e.g., 0 to 15 displacement corresponds to 0% to 100% output). When the footpedal is released,
it returns to the center position. Inward yaw movement controls reflux.
Yaw Control of Reflux

The footpedal may be programmed for use with either the right or left foot. Reflux (if selected) is always
activated by inward yaw displacement. For a right foot configuration, reflux is to the left (inward). For a left
foot configuration, reflux would be to the right. Reflux may only be activated when aspiration is not activated.
Yaw Control of Ultrasound Submode

For single linear setup, the ultrasound submode sequence (if programmed) is activated by inward or outward
yaw when the footpedal is in Region2 or Region3. In a Dual Linear Setup, the yaw control of the ultrasound
submode can only be activated (if programmed) by inward yaw when the footpedal is in Region2 or Region3.
Linear Coagulation Control

The control power is varied linearly from preset minimum to the preset limit. Power begins when entering
footpedal position1 and ends at the completion of travel.
Note: Due to compliance with IEC 60601-2-2, position1 will not start until approximately 35% of
pedal travel is attained in the linear coagulation mode.

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Center Foot Control for Anterior Modes
Phase Type Dual Linear Region Pitch Yaw Out

Control
R1 Irrigation
Next
Disabled R2 Fixed aspiration
submode
R3 Linear ultrasound
R1 Irrigation
R2 Aspiration R2
Disabled (with minimum to fixed
Next
aspiration control vacuum, vacuum
submode
feature on) limit, or flow
R3 Fixed aspiration &
linear ultrasound
R1 Irrigation
Aspiration on R2 Minimum
yaw** aspiration Linear
aspiration
R3 Linear ultrasound
Ultrasound
R1 Irrigation
R2 Aspiration R2
Aspiration on
minimum to fixed
yaw & aspiration
vacuum, vacuum To max.
control feature
limit, or flow aspiration
on**
R3 Min. aspiration and
linear ultrasound
Aspiration on R1 Irrigation
Pitch** R2 Linear aspiration Linear
ultrasound
R1 Irrigation
Dual Linear R2 Fixed Aspiration
Ultrasound*** R3 Linear U/S Linear
Function Ultrasound
R1 Irrigation
Disabled
R2 Linear aspiration
Irrigation/
aspiration R1 Irrigation
Dual Linear
Flow*** R2 Linear Vacuum or Linear Flow
Flow or Vacuum
Irrigation Only Disabled R1 Irrigation

2 User Interface
Phase Type Dual Linear Region Pitch Yaw Out

Control
Disabled R1 Irrigation
R2 Linear Aspiration Cutter on/off
& fixed vitrectomy
when on
Aspiration on R1 Irrigation
Pitch** R2 Linear Aspiration Linear
Vitrectomy
Vitrectomy Aspiration on R1 Irrigation
Yaw*** R2 Linear Vitrectomy Linear
Aspiration
Dual Linear R1 Irrigation
Flow*** R2 Linear Vacuum or Linear Flow
Flow and Fixed or Vacuum
Vitrectomy when
on
Coagulation Disabled R1 Linear Coagulation
** Only available at Programming Level2.

*** Only available at Programming Level3.

2

3 Customizing Your System
Customizing Your System

This chapter explains how to customize your Stellaris Vision Enhancement System to achieve maximum
flexibility for your operating needs.
Note: Surgical devices may not be operated during programming.
Each surgeon using the Stellaris Vision Enhancement System can program the system for their own preferred
operating configuration and instrument parameters. Several default surgeon preference files are pre-loaded on
the system, and you may copy and modify any of them through the Programming interface. You can create,
modify and backup surgeon setting preference files, as well as modify system parameters. The programming
screens are organized as outlined in the diagrams below.
Programming
Manage System Setup System System TruLink

Settings Configuration Calendar Remote
Access
Customize Create Backup Restore Delete Date / Time System ID Rooms
Surgeon Technique Foot Control Fluidics Video Overlay

Profile
Technique Phase Exceptions Foot Control Fluidics Audio/Visual

Profile
Phase Foot Control Fluidics Case Ultrasound Vitrectomy Coagulation

Profile Case Settings Settings
Aspiration Infusion Ultrasound Ultrasound

Settings Settings Settings Waveform
Settings

To program system parameters, select Programming from main clock menu on the Select Surgeon
Programming Level Screen or the Setup Surgical Screen.
The Main Programming Screen will appear, from which you can perform the following functions:
Manage Settings
System Setup
System Configuration
System Calendar
TruLink Remote Access (optional)
Each of these functions is described in more detail below.
At any time, you can select Programming to return to the Main Programming Screen, or Exit Programming
to return to the Select Surgeon Programming Level Screen or the Setup Surgical Screen. In either case, the
Stellaris Vision Enhancement System will ask if you want to save any changes you have made. Select Yes to
save your changes and overwrite existing files, and No to discard your changes.

3.1. Manage Settings

Select Manage Settings from the Main Programming Screen, and a new screen will appear through which
you can customize an existing surgeons file, create a new surgeon preference file by copying from an existing
one, backup files, restore files from a backup, or delete surgeon preference files.

Customize a Settings File

To change the settings for a currently existing preference file, select the Customize Tab on the Main
Programming Screen. A list of all surgeon preference files currently loaded on your Stellaris Vision
Enhancement System will appear. Select the name of the surgeon file to be modified, then select Confirm. The
Surgeon Programming Screen appears, with the file name along the left side of the screen, and seven tabs
across the top (see page3-5). These tabs are Profile, Technique, Foot Control Settings, Foot Control Regions,
Fluidics, A/V, and Video Overlay. Each tab allows you to make global changes to system parameters, and is
described in detail below.
System parameters can be customized at different levels. Global settings take place at the Technique Level.
Technique level settings can be overridden at the phase level. See the table at the end of this chapter for details
on which options can be customized at which level.

Customize Profile
To change the surgeons name associated with a settings file, or change the default language, select the Profile
Tab on the Surgeon Programming Level Screen. Select the surgeons name, and use the keyboard interface
that appears to modify the name of that file. Select the language, and a menu of all available languages will
appear, and you can select the one you prefer. You can also enable or disable use of the remote control.

Customize Technique
To change the techniques available for a particular surgeon or modify their settings, select the Technique Tab
on the Surgeon Programming Level Screen, and a list of currently defined techniques will appear. You can
select any technique from the current list and use the Move Up and Move Down buttons to rearrange the order
in which they appear. Select Add to add a new technique to the surgeons list. Select a technique then select
Delete to remove it, or select Customize to continue programming that technique.

To add a new technique to the list, select Add, then select any surgeon from the list that appears, and the
techniques defined for that surgeon will appear. Select a technique and select Confirm to add that technique the
original list.
To change the settings for a particular technique, select the technique, then select Customize. The Customize
Technique Screen will appear, with tabs for Profile, Phases, Exceptions, Foot Control, Fluidics and A/V.
Various parameters may be adjusted through various tabs, as described below.
Note: The programming level may be increased, to allow more control of feature details. However,
once it has been increased it may not be decreased.

Profile TabTechnique Name, Programming Level (1,2,3)

Phases TabEach technique may include up to eight phases. The Phases Tab shows the name of the
phase, and the mode for that phase (ultrasound, irrigation/aspiration). Phases can be added, deleted, or
re-ordered. They may also be customized, as described below.
Exceptions TabEach technique may include up to four exceptions. Exceptions can be added,
deleted, or re-ordered. They may also be customized, as described below.
Foot Control TabGroup or ungroup Foot Control Buttons, enable/disable next ultrasound
modulation on yaw, reflux type (none or continuous).
Fluidics TabAspiration types (Vac; Vac Modes, Flow: Vac Modes, Flow: Flow Modes, Flow: All
modes), IV Pole Height, Vacuum Response, Venting Method (Air or Fluid), Irrigation Shut-Off Delay
(ms), Pressurized Infusion Function (enabled/disabled), Pressurized Infusion Pump (on/off) and
Pressurized Infusion Settings (mmHg).
A/V TabDisplay Format (1 or 2), Status Bar Format (1, 2, 3)

Customizing Phases and Exceptions

Both Phases and Exceptions can be reordered and customized. Select a phase or exception from the list on the
appropriate tab, and the Customize button will appear. Select Customize, and more options specific to that
function will appear, and can be modified. These can include Phase Information, Foot Control settings, Fluidics
(Aspiration and Infusion), Ultrasound (Ultrasound and Wave Form), Vitrectomy, Coagulation settings. When
you are done making changes, select Exit Programming. The system will ask you to confirm your changes
before exiting.

Customize Foot Control

To modify the techniques for the Foot Control, select the Foot Control Tab on the Surgeon Programming
Level Screen. You can set the Foot Control to use right or left foot operation. The Mode Change Control
allows you to set the Stellaris Vision Enhancement System response when the footpedal is activated and you
change surgical modes. The Detent Control determines what feedback the Stellaris Vision Enhancement
System will give when changing footpedal regions. Use the Region Spin Control Buttons to change the
percent depression at which each region begins.

Customize Fluidics
To set the parameters for Fluidics functions, select the Fluidics Tab on the Surgeon Programming Level
Screen. You can set the BSS (Balanced Salt Solution) Bottle Type, Patient Eye Level (relative to the
aspiration port on the fluidics system), Ultrasound Needle Type, I/A Tip Type, and Electric Vit Tip Type, by
selecting the current setting. You can select the new setting from the drop down menu that appears.

Customize A/V (Audio/Visual)

To set the parameters for audio and visual functions, select the A/V Tab on the Surgeon Programming Level
Screen. You can adjust both Display Brightness and Master Volume by using the spin controls on this screen.
To change the tone or volume of a tone that is sounded for each condition, select the function from the list at the
bottom of the screen, and that condition will appear in the change section in the middle of the screen. Select the
desired tone from the option list, and use the spin control button to increase or decrease the volume.

Customize Video Overlay

To set the parameters for the MMC Video Overlay functions, select the Video Overlay Tab on the Surgeon
Programming Level Screen.
You can also set whether or not the system will combine Video Overlay Format information, such as U/S
Averages, settings, and case information. By default, the U/S data is shown as three separate lines on the video
overlay. If the U/S combine option is set to Yes, the display will appear on one line, which will step through the
three values. Similarly, settings are normally displayed on four lines, and case information on two lines, but if
the combine option is set to Yes each will appear on one line that will step through the values.
You can select the language to be used on the Video Overlay. You can set the Video Overlay overscan rate from
0% to 5%.

Create a New Settings File

To create a new surgeon preference file, select the Create Tab from the Manage Settings Screen, then select
the surgeons file which has settings most like the file you are going to create. Once you have highlighted a
preference file, the techniques in that file will be listed on the right side of the screen. Select techniques file by
highlighting the tabs on the left-hand side of the Techniques list.
Once the desired techniques are highlighted, select Confirm and a keyboard will appear, through which you can
enter the name for the new file, then select Enter. The name of the new file will appear on the left side of the
screen, and a new set of tabs (Profile, Technique, Foot Control, and Fluidics) will appear across the top of the
screen. These can be used to further customize the preference file (see page3-5).

Backup a Settings File

To backup an existing surgeon preference file to a USB memory device, select the Backup Tab from the
Manage Settings Screen, insert the device into one of the two USB ports on the back of the display panel.
Select the file or files to be backed up, the location to which they should be backed up, and select Confirm
(You must select the screen first, then insert device. System will only recognize USB device after this screen is
selected.)
Note: Memory devices complying with either USB1.1 or USB2.0 standards are supported by the
Stellaris Vision Enhancement System. Operations with other USB devices are NOT supported.

Restore a Settings File

To restore an existing surgeon preference file from a USB memory device,* insert the device into one of the
two USB ports on the back of the system console, behind the round sliding door. Make sure the Restore Tab is
active at the top of the Manage Settings Screen, select the file or files to be restored, and select Confirm (Must
select the screen first, then insert device. System will only recognize USB device after this screen is selected.)
*Select the Restore Tab from the Manage Settings Screen.

Delete a Settings File

To delete an existing surgeon preference file, make sure the Delete Tab is active at the top of the Manage
Settings Screen, select the file or files to be deleted, and select Confirm.

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.
Set Date, Time and Language

To change the system language, current date, time and format in which the time is displayed, select the Date/
Time Tab the top of the System Setup Screen. Select from the option list menus to change the default system
language, month, day, year, clock format (12 or 24hour), and current time in hours and minutes. Once all
changes have been made, select Confirm at the bottom of the screen to make your changes effective.

System ID
To monitor or change the identifying names of your Stellaris Vision Enhancement System, select the System
ID Tab at the top of the System Setup Screen. You can enter or update the account name and system name that
have been assigned to your Stellaris Vision Enhancement System. You can view the system catalog number as
well as its installation number.

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. Select Enter and the room name will be saved. You can also set the Maximum IV
Pole Height in centimeters, as measured from the aspiration port in the fluidics system, using the spin control
on this screen. This setting is to allow the system to be programmed to not hit the ceiling in a facility with
ceilings lower than nine feet (2.75meters).

3.3. System Configuration

To see a detailed listing of the software and hardware configuration of your system, select System
Configuration from the Main Programming Screen.

3.4. System Calendar

To set up your system to default to certain surgeon preference files and room numbers at certain times of the
week, select System Calendar from the Main Programming Screen, and the System Calendar Screen will
appear with four user-editable columns.
The second column, next to the listing of the days of the week, determines if the default surgeon applies to the
full day, or if separate defaults will be applied to the morning and afternoon of that weekday. Select or
to toggle between full day or morning and afternoon settings.
The third column contains option lists with the names of all the surgeon preference files currently available.
Select a file from the list, and that will be the default file when the Stellaris Vision Enhancement System starts
up at that time.
In the fourth column, select how many rooms that surgeon operates in, and in the fifth column selection which
room number this Stellaris Vision Enhancement System is located. These settings determine how the case
numbers will be incremented, to avoid duplicate case numbers for a single surgeon.

3.5. TruLink Remote Access
WARNING: You must contact your local Bausch+Lomb sales and support office before activating the
TruLink Remote Access function. See Technical Assistance on page8-2 for the sales
and support office that serves your location.
WARNING: Do not conduct surgery or any patient procedures while TruLink Remote Access is
activated. Serious patient injury may occur.
This features allows Bausch+Lomb technicians to remotely access your system, to diagnose problems and
provide updates.
To manage the secure point-to-point connection between your system and Bausch+Lomb, select TruLink
Remote Access from the Main Programming Screen, and a new screen will appear through which you can
monitor and initiate remote service on your system.

Select TruLink Remote Access, and ensure that the Ethernet cable is connected to the Stellaris Vision
Enhancement System, and to the designated hospital network port.
Note: If you have the optional MMC system, the Ethernet cable should be connected to the MMC, then
the MMC connected to the hospital Ethernet port.
Confirm that the system is not being used for surgery. The system will then be controlled by the remote
technician.
When the remote technician is finished, your Stellaris Vision Enhancement System will be shut down. You
may then restart the system.
Note: Off-the-shelf Ethernet cable may be used with the Stellaris Vision Enhancement System to
establish or restore connections.

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 (30characters max) Surgeon
Screen / voice English Surgeon
language
Display backlight 20% to 100%, by 5% Surgeon
brightness
System master audio 0% to 100%, by 5% Surgeon
volume
Tone selection and Irrigation, No tone, Tone1 - Tone10, 0% to 100%, by 5% Surgeon
volume control Vacuum, No tone, Tone1 - Tone10, 0% to 100%, by 5%
U/S, No tone, Tone1 - Tone10, 0% to 100%, by 5%
Bipolar, Tone1 - Tone10, 20% to 100%, by 5%
Vit, No tone, Tone1 - Tone10, 0% to 100%, by 5%
Occlusion, 0% to 100%, by 5%
Error, 20% to 100%, by 5%
Voice confirmation Enabled / Disabled Surgeon
Volume: 0% to 100%, by 5%
Video overlay English Surgeon
language
Video overlay display Combine case information lines - No, Yes Surgeon
format Combine ultrasound averages lines - No, Yes
Combine settings lines - No, Yes
Video overlay 0% to 5%, by 1% Surgeon
overscan allowance
Technique Name Typewriter Data Entry (20characters max) Technique
Surgical Mode Format1, Format2 Technique
Display Format
Status Bar Display Format1, Format2, Format3 Technique
Format

Case Customization Levels
Parameter Options/Ranges/Step Sizes

Programming Level Level 1, Level 2, Level 3 Technique
Programming Level2 Disabled, Enabled Technique,
Customize Settings by Phase
Case
Programming Level2 Disabled, Enabled Technique
Customize Fluidics
Settings by Needle/
Tip
Customize Fluidics
Settings by Cataract
Grade
Customize Fluidics
Settings by Pathology
Customize Ultrasound
Settings by Needle/
Tip
Settings by Cataract
Grade
Settings by Pathology
Programming Level2 Typewriter data entry (20characters max) Technique
Pathology Name
Phase Name Typewriter data entry (8characters max) Phase
Mode Type Ultrasound, Irrigation/Aspiration, Irrigation, Coagulation, Phase
Pneumatic Vitrectomy, Electric Vitrectomy
Mode Icon All icons for the given mode type Phase
Ultrasound Submode Typewriter data entry (20characters max) Phase
Name

Foot Control
Parameter Options/Ranges/Sizes
Operation Right Foot, Left Foot Surgeon
Mode change control Not While Active, Allow-Limit Pedal, Allow-Remap Surgeon
Pedal, and Allow-No Limiting
Detents Disabled, Enabled (R1/R2/R3), Enabled (R2/R3) Surgeon
Starting position Region1: 2% to 5%<R2 start, by 5% Surgeon
Region2: 5%>R2 start to 5%<R3 start, by 5%
Region3: 5%>R2 start to 95%, by 5%
Group toe/ heel Left side: Group / Ungroup Technique
switches Right side: Group / Ungroup
Dual Linear Enable Programming Level1: Technique
Disabled (not displayed, not programmable)
Programming Level2 / Level 3:
Disabled, Enabled
Linear Coagulation in Disabled, Enabled Technique
Setup Mode
Grouped switch Unassigned, Mode, U/S Submode, Vacuum, Flow, Bottle Technique,
assignment Height, U/S Power, U/S PPS/Duration, U/S DC/Interval, Phase
Coag Power, Vit Cut Rate
Ungrouped switch Unassigned, Next Phase, Previous Phase, Next U/S Technique,
assignment Submode, Confirm Settings, Irr On/Off, Continuous Phase
Reflux, Vit On/Off, Fixed Coag
Reflux Vacuum Fluidics: None, Continuous Technique,
AFS Fluidics: None, Single, Repeat, Continuous Phase
Next Ultrasound Disabled, Enabled Technique,
Modulation on Yaw Note that for single linear foot pedal modes, the Phase
outward yaw motion would be used for next ultrasound
modulation, and for dual linear foot pedal modes, the
inward yaw motion would be used.
Fixed Coagulation 0% to 10% by 1% Technique,
Power Level 10% to 30% by 2% Phase
30% to 100% by 5%
Applicable if one of the Foot Control buttons is
programmed to activate fixed coagulation.
Dual Linear Control Mode Level: (If Enabled at Technique Level) Phase
U/S Modes: Disabled, Asp on Yaw, Asp on Pitch, Dual
Linear U/S
I/A Modes: Disabled, Programming Level3 Dual Linear
Flow (only for AFS fluidics if flow modes enabled)
Vit Modes: Disabled, Asp on Pitch, Programming Level3
Asp on Yaw, Programming Level3 Dual Linear Flow
(only for AFS fluidics if flow modes enabled)
Irr Mode / Coag Modes: Disabled (not displayed)

Fluidics

Max bottle height 30 to 140cm, by 5cm System
Balanced Salt 500ml Bottle, 500ml Bag, 250ml Bottle Surgeon
Solution Container
Type
Patient Eye Level -15cm to +15cm Surgeon
Default Ultrasound Standard, MicroFlow+, MicroFlow, Thin Tip, Coaxial Surgeon
Tip Type MICS, Stable Flow 20Gauge, Stable Flow 19Gauge
Default /A Tip Type 0.3mm, 0.5mm Surgeon
Default Vitrectomy 20Gauge Pneumatic, 20Gauge Electric, 25Gauge Surgeon
Tip Type Electric
Fluidics Types VFM: Vac Modes Technique
AFM: Vac Modes, AFM: Flow Modes, AFM: All Modes
IV Pole bottle height 30 to 140cm, by 5cm Technique,
Phase/Case
Irrigation Delay 100 to 3000ms, steps of 50milliseconds. Also resolution Technique,
of 50ms even with calculator Phase/Case
Vacuum Response (1) Fastest, 2, 3, 4, (5) Slowest Technique,
Phase/Case
Programming Level2 Fluid Venting, Air Venting Technique,
Vent Method Phase/Case
Pressurized Infusion Disabled/Enabled Technique
Displayed
Pressurized Infusion On/Off Technique
Pump
Pressurized Infusion 0mmHg to 20mmHg, by 2mmHg Technique,
Pressure 20mmHg to 100mmHg, by 5mmHg Phase/Case


Aspiration type Fixed vacuum Phase/Case
Types available Fixed vacuum, with aspiration control feature
depend on aspiration Linear vacuum
types enabled at the Programming Level2 Linear vacuum, with aspiration
technique level, the control feature
dual linear control Fixed flow fixed vacuum
option, and the mode Fixed flow fixed vacuum, with aspiration control feature
handpiece type controlling flow
selected. Fixed flow fixed vacuum, with aspiration control feature
controlling vacuum
Fixed flow linear vacuum
Programming Level2 Fixed flow linear vacuum, with
aspiration control feature controlling flow
Programming Level2 Fixed flow linear vacuum, with
aspiration control feature controlling vacuum
Linear flow fixed vacuum
Programming Level2 Linear flow fixed vacuum, with
aspiration control feature controlling flow
Programming Level2 Linear flow fixed vacuum, with
aspiration control feature controlling vacuum
Programming Level3 Linear flow linear vacuum limit
(available only in Irrigation / Aspiration and fixed
Vitrectomy modes)
Fixed vacuum level 0mmHg to 20mmHg by 1mmHg Phase/Case
or linear vacuum 20mmHg to 200mmHg by 5mmHg
maximum level, for 200mmHg to 600mmHg by 10mmHg
vacuum modes Minimum of 10mmHg for U/S modes
0ml/min to 10ml/min by 1ml/min Phase/Case
Fixed flow level or 10ml/min to 30ml/min by 2ml/min
linear flow maximum 30ml/min to 60ml/min by 5ml/min
level, for flow modes Minimum of 5ml/min for U/S modes
Fluidics - Fixed 0mmHg to 20mmHg by 1mmHg Phase/Case
vacuum limit level or 20mmHg to 200mmHg by 5mmHg
linear vacuum limit 200mmHg to 650mmHg by 10mmHg
maximum level, for Minimum of 10mmHg for U/S modes
flow modes
Programming Level2 0mmHg to 20mmHg by 1mmHg Phase/Case
Linear vacuum 20mmHg to 200mmHg by 5mmHg
minimum level, for 200mmHg to 600mmHg by 10mmHg
vacuum modes Minimum of 10mmHg for U/S modes
Region2 minimum 20mmHg to 200mmHg by 5mmHg
vacuum, for aspiration 200mmHg to 600mmHg by 10mmHg
control feature
vacuum modes


0ml/min to 10ml/min by 1ml/min Phase/Case
Programming Level2 10ml/min to 30ml/min by 2ml/min
Linear flow minimum 30ml/min to 60ml/min by 5ml/min
level, for flow modes Minimum of 5ml/min for U/S modes
Programming Level2 0ml/min to 10ml/min by 1ml/min Phase/Case
Region2 minimum 10ml/min to 30ml/min by 2ml/min
flow, for aspiration 30ml/min to 60ml/min by 5ml/min
control feature flow
modes with control on
flow
Linear vacuum limit 20mmHg to 200mmHg by 5mmHg
minimum level, for 200mmHg to 650mmHg by 10mmHg
flow modes Minimum of 10mmHg for U.S modes
Region2 minimum 20mmHg to 200mmHg by 5mmHg
vacuum limit, for 200mmHg to 650mmHg by 10mmHg
aspiration control
feature flow modes
with control on
vacuum limit
Programming Level2 Linear, Front Loaded, Back Loaded Phase/Case
Foot control mapping
(for linear control)
Programming Level3 Vacuum limit, Flow Phase/Case
Pitch function for dual
linear flow aspiration
modes
(for yaw function
linear control in dual
linear aspiration flow
modes)

Ultrasound

Ultrasound Continuous Phase/Case
Modulation Type Pulsed
Single burst
Fixed pulse
Multiple burst
Programming Level3 Linear Power Linear Pulse
Programming Level3 Linear Power Linear Duty Cycle
Programming Level3 Dual Linear Multiple Burst
Programming Level3 Variable Power Multiple Burst
Programming Level3 Variable Power Linear Burst
Fixed power level 0% to 10% by 1% Phase/Case
or linear power 10% to 30% by 2%
maximum level 30% to 100% by 5%
Pulse rate for pulsed 0PPS to 20PPS by 1PPS Phase/Case
modes 20PPS to 50PPS by 5PPS
50PPS to 250PPS by 10PPS
Subject to minimum on time of 2ms and a minimum off
time of 2ms
Duty cycle fixed or 5% to 95% by 5% Phase/Case
maximum for pulsed Subject to minimum on time of 2ms and a minimum off
modes time of 2ms
Burst or pulse 2ms to 20ms by 2ms Phase/Case
duration for burst 20ms to 80ms by 5ms
modes or fixed pulse 80ms to 600ms by 20ms
modes
Burst interval for 2ms to 20ms by 2ms Phase/Case
fixed pulse modes 20ms to 80ms by 5ms
80ms to 600ms by 20ms
Maximum duty cycle 50% to 99% by 5% Phase/Case
for multiple burst Subject to a minimum off time of 2msec and a maximum
modes off time of 1500msec
Waveform Ultrasound Disabled, Enabled Phase/Case
Programming Level2 0% to 10% by 1% Phase/Case
Linear control power 10% to 30% by 2%
minimum level 30% to 100% by 5%
Minimum duty cycle 10% to 30% by 2%
for multiple burst 30% to 50% by 5%
modes Subject to a minimum off time of 2msec and a maximum
off time of 1500msec


(for linear control) -
front loaded, linear,
back loaded
Programming Level3 Ramped (not programmable) Phase/Case
Waveform Type
Programming Level3 250ms to 1000ms by 50ms Phase/Case
Waveform duration (resolution of 50ms even with calculator)
Waveform Depth
Programming Level3 1PPS to 20PPS by 1PPS Phase/Case
Pulsed mode linear 20PPS to 50PPS by 5PPS
pulse rate minimum 50PPS to 250PPS by 10PPS
Subject to minimum on time of 2ms and a minimum off
time of 2ms
Pulsed mode linear Subject to minimum on time of 2ms and a minimum off
duty cycle minimum time of 2ms
Programming Level3 2ms to 20ms by 2ms Phase/Case
Burst mode linear 20ms to 80ms by 5ms
duration minimum 80ms to 600ms by 20ms
Programming Level3 Linear, Front Loaded, Back Loaded, Reverse Linear, Phase/Case
Foot control mapping Reverse Front Loaded, Reverse Back Loaded
(for second ultrasound
linear control)

Vitrectomy

Fixed cut rate or linear Pneumatic: Phase
cut rate maximum rate 30CPM to 800CPM by 30CPM
Electric:
600CPM to 1500CPM by 50CPM
Programming 2 Linear Pneumatic: Phase
cut rate minimum rate 30CPM to 800CPM by 30CPM
Electric:
600CPM to 1500CPM by 50CPM
Programming 2 Foot Linear, Front Loaded, Back Loaded, Reverse Linear, Phase
control mapping Reverse Front Loaded, Reverse Back Loaded

Coagulation

Coag - Power level 0% to 10% by 1% Phase
maximum level 10% to 30% by 2%
30% to 100% by 5%
Programming Level2 0% to 10% by 1% Phase
Power level minimum 10% to 30% by 2%
level 30% to 100% by 5%
Programming Level2 Linear, Front Loaded, Back Loaded Phase

4 Detailed Reference
Detailed Reference
This chapter provides a detailed reference for each system function and accessory, and surgical procedure setup
and operation.
WARNING: Do not use in the presence of flammable anaesthetics, disinfectants, aerosol sprays, or in an
Note: 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 19inch, 5:4aspect ratio color touch screen display, which is the
primary interface between you and your system. The display console may be tilted 10 forward and 15 back,
and swiveled 90 right or left. The brightness of the display is controlled through the A/V More Screen (see
page2-11).
At the bottom of the screen is an infrared receiver which interfaces with the remote control.
The computer system includes both audio and visual capabilities, which provide warning messages, alarms,
and other audio indications, as well as allowing you to view setup screens, surgical settings, and video from a
microscope camera. The volume is adjustable via the touch screen spin buttons on the A/V More Screen.
Two USB ports on the back of the display allow you to save, load and transfer your customized settings between
systems.

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.
Note: Do not use the IV Pole for a handle.
The system sits on four rotating casters. The front two wheels can be locked in place by pressing down on the
wheel brake lever with your foot. Pulling up on the wheel brake releases the lock.

Fuse holder Main Power Switch

Ethernet Port
Power Cord Retention Clip Power Cord Input

Foot Control Backup Cable Port
On the lower back of the system console are the ON/OFF power switch, power cord port, Ethernet port, and
Foot Control cable port.

IV Pole
System Switch
ON/OFF
Pneumatic Anterior
Vit Acuator
Fluidic Module
Surgical Tray
Drawer

4.3. IV Pole
WARNING: Use of an IV Pole extension or other means of altering the bottle height may cause inaccurate
setting displays resulting in serious permanent patient injury.
CAUTION: Do not manually force the IV Pole or use the IV Pole as a handle.
The Stellaris Vision Enhancement System IV Pole is an integral part of the system console. It can be directly
moved up, down, or to a specific preset height by through any of several methods. It can be controlled through
the touch screen, Foot Control (if programmed), remote control, or directly by using the buttons on the back of
the system console. The IV Pole can also be pre-programmed to a certain height for various surgical modes. The
system will not compensate if the bottle height is altered though the use of IV Pole extensions or other hardware
not provided with the system.
To change the bottle height during surgery, use the up and down arrows on the IV Pole control section of the
Surgical Screen (See page4-5), or use the buttons on the back of the system console.
In the lowest (stowed) position and with a 500ml bottle, the IV Pole will provide approximately 30cm.
(12in.) of infusion pressure, measured from the aspiration port to the middle of the Balanced Salt Solution drip
chamber. This is an equivalent pressure (not Intraocular Pressure) of 22.4mm Hg. The IV Pole can extend to
140cm (55in.), an equivalent pressure of 102.74mmHg.
To change the programmed bottle height settings for the current surgical mode, select the Fluidics More Screen
(See page2-7), then select the Infusion Tab to change the actual height, preset height, or the maximum height the
IV Pole is allowed to reach.
The maximum IV Pole height should be set when installing the Stellaris Vision Enhancement System in a
particular medical facility. You can do this using the programming interface (see Chapter3).

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 field.
The remote control transmits an infrared signal to the receiver at the bottom of the touch screen. For critical
functions you can activate a command directly through the remote control. The commands which may be given
from each remote control button are shown in the figure below.
The remote control is powered by two AA batteries, which should be replaced when the low battery light comes
on. Access the remote control batteries by removing the battery cover on the back of the remote.
Transmitting Signal Light Next Phase
Low Battery Light Bottle Height Phaco / Vitrectomy, or

Coagulation
Previous Phase
Vacuum
Flow Reserved for Future Use
Note: The batteries should be removed from the remote control if the system is to be idle for more than
30days.
Note: It is your responsibility to dispose of batteries in a safe and environmentally-responsible manner

in accordance with local regulations.

4.5. Advanced Vacuum System Fluidics
Note: Each Stellaris Vision Enhancement System has either an Advanced Vacuum Fluidics or an
Advanced Flow Fluidics function.
WARNING: For optimum aspiration and reflux performance, the patients eye level must be at the
same level as (no more than 7cm [3in.] from) the Stellaris Vision Enhancement System
aspiration port. Failure to follow this procedure may result in serious and permanent patient
injury.
With your Stellaris Vision Enhancement System, the irrigation line from an inverted bottle of Balanced
Salt Solution is integrated into the tubing manifold at the top of the vacuum cassette. The delivery pressure of
the Balanced Salt Solution is adjusted by varying the height of the bottle in relation to the patients eye. For
pressurized infusion, pressure is determined by the pressure setting of the air pump (see page4-31 for details).
On/off control of irrigation is accomplished through the footpedal, or via the touch screen.
As the cassette fills up, the system will give a Cassette Nearing Full warning. When the fluid level reaches
the maximum capacity, the system will give a Cassette Full warning. After this second warning, the aspiration
function will be disabled. You must replace the fluidics cassette that is either empty or nearly empty and reprime
before aspiration will be re-enabled.
Irrigation-Aspiration
Irrigation
Irrigation is part of the fluidics system, providing continuous fluid flow to compensate for fluid aspirated out
of the eye. Irrigation on/off is controlled by the pinch valve, which is opened when the footpedal is pressed and
closed when the footpedal is released.
An Irrigation-only mode is available, in which the footpedal controls irrigation on/off. The Fill Button on the
Surgical Screen opens the irrigation control valve for 20seconds to facilitate collection of irrigation solution
into a surgical container.
Irrigation/Aspiration
Note: Tubing must not be pulled tautit must be allowed to have a droop or sag between the cassette
and the handpiece.

Note: Whenever the cassette is ejected from the system console, keep the handpiece above the level of
the cassette port.
The Advanced Vacuum Function provides vacuum levels from 0mmHg to 600mmHg in 1mmHg increments
depending upon the mode of operation. Aspiration limits are set via the touch screen, the remote control, or the
Foot Control buttons (if programmed).
In I/A mode, irrigation is activated in Region1 of footpedal travel, and both irrigation and aspiration are
activated in Region2 of footpedal travel.
Capsule Polish
The capsule polish function is typically accomplished with a lower vacuum setting than standard settings. These
settings may be customized to allow quick entry into a lower vacuum level as explained in Chapter3.
Viscoelastic Removal
The viscoelastic removal function provides different settings for the doctors convenience. These settings may
be customized to allow quick entry into a specific vacuum level as explained in Chapter3.
Venting
The Vacuum Fluidics system provides the surgeon with either air or fluid venting options to free an occluded
tip when the footpedal is released. When air venting is selected, the vacuum build up is vented to atmospheric
pressure, and when fluid venting is selected, it is vented to a positive pressure equal to the bottle height head
pressure.
Reflux
Aspiration of fluid to the collection cassette occurs via the handpiece and a tube set. Reflux applies a
momentary reverse pressure through the aspiration line to clear the aspiration port of lodged material, and is
generated, in the Advanced Vacuum system, by irrigation pressure.
The Stellaris Vision Enhancement Systems Advanced Vacuum system is designed for use with continuous
reflux, but for any surgical mode reflux may be programmed to be either continuous or off (none). If enabled,
the reflux feature is activated by inward movement of the footpedal in all aspiration modes.
Vacuum Response
Vacuum response refers to the amount of time required to obtain the desired aspiration level. A fast response
value instructs the system to achieve the desired aspiration level in the shortest amount of time; similarly, slow
indicates that the time to achieve the desired aspiration will be much longer. The response can be changed
through the programming interface (see Chapter3) or the Fluidics More Screen (see page2-7). The Stellaris
Vision Enhancement System Advanced Vacuum System has five levels of vacuum response setting, with one
being fastest response and five being slowest response.

Foot Control of Irrigation/Aspiration

As the footpedal is initially pressed, the irrigation control valve will open to allow irrigation into the eye.
Once irrigation has been initiated and the footpedal has been depressed approximately five degrees (or as
programmed), a momentary increase in footpedal resistance will be noted signifying the transition from
Region1 to Region2 and the start of aspiration. Aspiration increases proportional to footpedal travel with the
maximum level being set via the Max Vacuum input on the touch screen. You can program Region2 to provide
either fixed or linear vacuum control. The Actual Vacuum display will indicate the current aspiration level.
If enabled, an audible linear tone will indicate aspiration. The pitch of the tone increases with increased
aspiration.
WARNING: Improper reassembly of tubing manifold to the cassette may result in inadequate system
performance.
Instructions To Empty Cassette

The Stellaris Vision Enhancement Systems Advanced Vacuum Fluidics cassette can be emptied during
operation with following instructions:
1. Stop operation and protects handpiece with test chamber.

2. Close irrigation clamp.
3. Select Setup from surgical screen to transition to Setup screen.
4. Select Eject Cassette from the setup screen.
5. Remove cassette from the system.
6. Detach the aspiration tubing that connects to the cassette. Hold aspiration tubing very close to the
connector to facilitate removal (Pink arrows).

7. Press manifold to release latch to free it from the cassette (Pink arrows).
8. Drain fluid out of the cassette.
9. Assemble tubing manifold by first sliding the front end under the cassette retainer (R).
10. Press the manifold to engage manifold latch.

11. Connect aspiration tubing to the cassette connector.
12. Insert cassette to the system.

13. Release irrigation clamp.
14. Select Prime Only on the Setup screen to re-prime the cassette before use.

4.6. Advanced Flow System Fluidics
WARNING: For optimum aspiration and reflux performance, the patients eye level must be at the same
level as (no more than 7cm [3in.] from) the Stellaris Vision Enhancement System aspiration
port. Failure to follow this procedure may result in serious and permanent patient injury.
WARNING: Ensure the maximum capacity of the fluid collection device is not exceeded as this could
cause a hazardous situation to the patient.
The Stellaris Vision Enhancement Systems Advanced Flow system consists of a retractable cartridge drawer,
a vacuum transducer system, a drive motor, control solenoids and electronics.
The Advanced Flow System cartridge is manually loaded and sits tightly in the drawer slot. Select Close
Drawer to engage the device.
Irrigation-Aspiration Mode
Irrigation
With your Stellaris Vision Enhancement Systems Advanced Flow system, the irrigation line from an inverted
bottle of Balanced Salt Solution is attached through the Advanced Flow System cartridge to the surgical
handpiece. The delivery pressure of the irrigation solution is adjusted by varying the height of the bottle in
relation to the patients eye. On/off control of irrigation is accomplished through the Foot Control or touch
screen. The inward yaw action of the Foot Control will always provide Continuous Reflux in the irrigation
mode, overriding the global reflux option that applies in all other modes.
Irrigation/Aspiration
A single aspiration port, driven by the disposable Advanced Flow System cartridge, provides flow control of
aspiration.
Flow Control: Aspiration in the flow mode of operation will provide flow rates from 1ml/min. to 60ml/min.
in 1ml/min. increments and vacuum limit control from 0mmHg to 650mmHg in 5mmHg increments utilizing
the up/down spin buttons. Aspiration limits are set via the touch screen and adjusted via the Foot Control or
remote control.
There are two modes of flow control: Fixed Flow Linear Vacuum Limit and Linear Flow Fixed Vacuum Limit.
Capsule Polish
The capsule polish function is typically accomplished with a lower vacuum limit setting than standard settings.
These settings may be customized to allow quick entry into a lower vacuum limit level as explained in Chapter3.

The viscoelastic removal function provides different settings for the doctors convenience. These settings may
be customized to allow quick entry into a higher vacuum limit level as explained in Chapter3.
Venting
The Advanced Flow Fluidics system provides the surgeon with either air or fluid venting options to free an
occluded tip when the footpedal is released. When air venting is selected, the vacuum build up is vented to
atmospheric pressure, and when fluid venting is selected, it is vented to a positive pressure equal to the bottle
height head pressure.
Reflux
Aspiration is applied via the Advanced Flow Pump and subsequently to the surgeons handpiece via a tube set.
Reflux applies a momentary pressure through the aspiration line to clear the aspiration port of lodged material.
An additional reflux option is continuous reflux used to ease needle insertion through the incision. The reflux
feature is applied with the inward rotation of the footpedal in all aspiration modes. Yaw inward the footpedal
initiates the reflux cycle, releasing it completes the cycle. Subsequent reflux cycles may be applied with
repeated footpedal operations. Single reflux is limited. Forward revolutions of the pump are required before
reflux may be actuated.
Vacuum Response
Vacuum response refers to the amount of time required to obtain the desired aspiration level. A fast response
value instructs the system to achieve the desired aspiration level in the shortest amount of time; similarly, slow
indicates that the time to achieve the desired aspiration will be much longer. The response can be changed
through the programming interface (see Chapter3) or the Footpedal More Screen (see page2-10).
Foot Control of Irrigation/Aspiration

As the footpedal is initially pressed, the irrigation control valve will open to allow irrigation into the eye.
Region1 to Region2 and the start of aspiration. In Region2, aspiration will be either fixed or proportional to
footpedal travel, as programmed. The maximum level is set by the Max Flow, Max Vacuum, and Vacuum
Response Time setting on the touch screen. The Actual Flow and Actual Vacuum display will indicate the
current aspiration level.
aspiration.
Irrigation/Aspiration Setup
Refer to detailed instructions on page4-14. The only difference when using the Advanced Flow system is that the
fluid collection device is a bag instead of a cassette, and you must select Close Drawer on the Setup Screen
after inserting the cartridge.

Vitrectomy Mode
Similar to the Vacuum Fluidic module, the Stellaris Vision Enhancement System Advanced Flow module
offers a High Speed pneumatic vitrectomy cutter. The pneumatic vitrectomy cutter uses pressurized air
generated from an internal pump to drive the pneumatically operated guillotine type vitrectomy cutter. The
vacuum fluidic module provides aspiration to draw the vitreous material into the port and vitreous is then cut
and aspirated into the disposable collection container through the attached tubing.
For detailed instructions for setup and use, see page4-17.
4.7. Irrigation/Aspiration Setup
WARNING: For optimum aspiration and reflux performance, the patients eye level must be at the same
level as (no more than 7cm [3in.] from) the Stellaris Vision Enhancement System aspiration
port. Failure to follow this procedure may result in serious and permanent patient injury.
WARNING: Assure the handpiece and accessories are sterilized before use as specified.
Note: Do not use StellarisPC Vision Enhancement System posterior or combined packs on a
Stellaris system.
Note: Specific instructions for cleaning and sterilization included with the handpiece or accessory
take precedence over these instructions.
a. Turn Power on.

b. Press any button on the Foot Control and wait until the right light turns solid green indicting wireless
communication has been established.
c. Select Surgeons Name and select Confirm.
d. Open disposables pack and insert fluid collection system:
If using a vacuum system, insert the fluidics cassette all the way in and hold until it is automatically
captured by the system. The cassette housing backlight will stop blinking and turn solid when the
system captures the cassette.
If using a flow system, insert the fluidics cartridge and select Close Drawer.
System will start cassette vacuum test or cartridge calibration automatically.
e. After vacuum test or cartridge calibration completes, the Setup Screen will display with Prime and
Tune as the highlighted function.

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
filter to the Stellaris air output connector. Switch on the air pump from the system setup screen, the
control is at the upper right hand of the screen. The output connector will remain lit when it is at
commanded pressure, and blink on and off when it is not at the commanded pressure.
g. Connect tubing to the I/A handpiece. Select Show Me Steps for animated setup guide, if necessary.
h. Ensure the irrigation clamp is open and select irrigation OFF to turn the flow on and allow irrigation to
fill the tubing up to the handpieces. See page4-5 for details on the irrigation flow button (activating the Fill
button will turn flow on for 20seconds).
i. Fill the test chamber with irrigating solution, then slide over the tip of the handpiece.
j. Select Prime Only. A vacuum test is part of the priming cycle.
k. After successful priming and tuning, the Main Surgical Screen will appear.
The external components of your system are now ready. Continue to set the operating parameters.
Note: Hold the handpiece tip towards the ceiling while priming the irrigation line to insure all air has
been removed.
Use
a. Select the I/A mode on the clock menu.
b. Use the spin control buttons to set the desired aspiration vacuum.
c. Confirm that irrigation and aspiration are balanced by pinching the irrigation line and observing that the
test chamber dimples.
d. The system is now ready for Irrigation/Aspiration.
Note: See Chapter5 for cleaning and sterilization requirements when surgery is completed.
4.8. Vitrectomy Function

The Stellaris Vision Enhancement System supports both a pneumatic (standard) and a high-speed electric
(optional) vitrectomy cutter. The pneumatic vitrectomy cutter uses pressurized air generated by an internal
compressor to drive the guillotine-type vitrectomy cutter. The Advanced Vacuum system provides aspiration to
draw the vitreous material into the port, where it is then cut and aspirated through the flexible tubing into the
disposable collection container.

Vitrectomy Cutter Modes

The Advanced Vacuum System provides two vitrectomy cutter modes:
Fixed Cut
Pneumatic cutter: The control may be adjusted to provide a fixed cutting speed from 30 to 800cuts
per minute in 30cuts per minute increments utilizing the up/down spin buttons, or one cut per minute
increments utilizing the numeric keypad.
Dual Linear Cut

Pneumatic cutter: The control may be adjusted to provide a linear cutting speed from 30 to 800cuts
per minute in 30cuts per minute increments utilizing the up/down spin buttons, or one cut per minute
increments utilizing the numeric keypad.
WARNING: Never intentionally modify handpieces or tips, such as do not bend, cut or engrave, as they
could break or malfunction.

Planned Vitrectomy Setup
injury.
a. Turn Power on.

b. Press any button on the Foot Control and wait until the ready light turns solid green, indicating wireless
e. Spike the Balanced Salt Solution bottle and hang it at the desired bottle height.
f. Ensure the irrigation clamp is open, connect the irrigation and aspiration lines together, and select
Prime. Select Show Me Steps for animated setup guide if needed.
g. Open appropriate vitrectomy cutter pack. If you are using the pneumatic cutter, connect tubing and the
actuation line to the pneumatic port on the Stellaris Vision Enhancement System.
h. Apply a pinch clamp (not supplied) at the end of the irrigation line to shut off irrigation flow when using
the vitrectomy cutter without irrigation. Do not close the clamp on the administration line.
i. Ensure the irrigation clamp is opened and the tip is immersed in irrigation solution, then select Cutter
Test.
j. After successful test, select Advance to Surgery and the Main Surgical Screen will appear.
Use
a. Select Vit from the clock menu. The Show Me Steps animated setup guide will appear.

b. Use the spin control buttons to set the desired vacuum level and cut rate.
c. For Fixed cut vitrectomy, yaw the footpedal outward to toggle the cutter on and off, and depress the
footpedal for aspiration. An audio tone will signify cutter operation (if enabled). Fixed cut rate is
activated in footpedal Region2.
d. For Linear cut vitrectomy, activate the cutter by outward yaw travel of the footpedal in Region2.
e. For Reflux (if enabled), yaw the footpedal inward.
Unplanned Vitrectomy Setup

In the event anterior vitrectomy is needed during phaco surgery:
a. Select the Vitrectomy mode from the clock menu. The Show Me Steps animated setup guide will
appear. Select Close to close the animated setup guide.
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. Select Show Me Steps for animated setup guide if needed.
d. After a successful test, select Advance to Surgery and select the Vit phase from the clock menu.

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.
Region1 to Region2 and the start of aspiration. Aspiration increases proportional to footpedal travel with the
maximum level being set via the Max Vacuum input on the touch screen. Region2 will provide linear control
of aspiration. The Actual Vacuum display will indicate the current aspiration level.
aspiration.
For Fixed Cut vitrectomy mode, vitreous cutting is activated in Region2. The cut rate is fixed. Each successive
outward yaw movement toggles the cutter ON or OFF. If enabled, an audible tone will indicate cutter on (double
beep) or cutter off (single beep).
For Dual Linear Cut mode, outward yaw movement provides linear control of the cut rate as a function of
footpedal displacement once it is within Region2. The actual cut rate is displayed on the screen. When the
footpedal is released, it returns to center and the cutter is disabled. If enabled, an audible linear tone indicates
cut rate, and the pitch of the tone increases with increased cutter speed.
Reflux (if enabled) is by inward yaw movement of the footpedal.
At default, the vitrectomy cutter is set at On.

4.9. Ultrasound Function

Phacoemulsification refers to the process of ultrasonic disintegration of the lens using a vibrating needle
operating at a frequency above the audible range, in the anterior chamber of the eye.
The Stellaris phaco handpiece is designed with SureLock, a luer lock irrigation connector, to prevent tubing
coming off during surgery and uses Attune energy management system, based on 6-crystal technology and
advanced power modulation software (see programming section for details).
Ultrasound Power
The ultrasound display allows you to adjust maximum ultrasound power pulses per second (PPS), duty cycle
(DC), pulse duration, and pulse interval. Both the current setting and actual value are shown on the Surgical
Screen display. The status bar (see page2-14), visible at the top center of the surgical screen, may display the
average ultrasound power (AVE), actual phaco time (APT), and effective phaco time (EPT), depending on
system settings.
The AVE display is internally calculated as the arithmetic average of all phaco power used since last reset. The
APT display indicates the time in minutes and seconds that phaco power has been energized since last reset. The
EPT is derived from multiplication of AVE and APT. Use the Case More Screen (see page2-13) to reset the phaco
timer and average. The timer is also reset when you select Next Patient on the End of Case Screen.
Pulse Mode Ultrasound

Pulse mode ultrasound power may be adjusted from 1% to 100% using the up/down spin buttons, Foot Control
buttons, or remote, and 1% increments using the keypad. Pulse output control is programmable from 1 to
250pulses per second in 1pulse per second (PPS) increments.
The pulse rate control does not adjust the ultrasound power. The control adjusts the number of cycles of
ultrasound power that occur during a one second time interval. In Pulsed Ultrasound Mode, the phaco
handpiece is energized for the portion of each time interval as programmed by the Duty Cycle setting.
Burst Mode Ultrasound

Burst mode ultrasound is an anterior only mode to provide minimal ultrasound energy. Ultrasound is applied
in either single or multiple burst using a fixed power or in fixed burst using a linear control of power. The burst
duration can range from 2 to 600msec.
When single burst mode is selected, a burst of ultrasound energy is emitted when the Foot Control is pressed to
90% of the linear control position, and is reset when the pedal is released to less than 90% of the linear control
position.
Power
Single Burst
Pedal Position

When fixed pulse mode is selected, the pulse duration and interval may be selected with the screen settings. The
ultrasound power is controlled by the linear control position of the footpedal.
Power
Fixed Pulse
Pedal Position
When multiple burst mode is selected, a sequence of bursts of ultrasound energy are emitted. The time interval
between bursts is controlled by the linear control position of the footpedal. When the pedal reaches full travel in
the linear control, the ultrasound energy is limited by the Max Duty Cycle setting.
Power
Multiple Burst
Pedal Position
Ultrasound Submode
Up to three sets of ultrasound modulation settings may be stored with each ultrasound mode (see Description
of Ultrasound Modes, page4-22). Foot Control activation of the submode sequence may be enabled or disabled.
Submodes can be toggled with the Foot Control heel switch or by footpedal outward yaw motion in Region2 or
3, depending on how the system has been programmed.
The options to change submodes with the Foot Control are:

Either the left side button pair or the right side button pair may be grouped to change submodes to the
next submode (toe) or previous submode (heel)
Any of the four Foot Control buttons may be assigned to advance to the next submode (when
ungrouped)
The outward yaw switch may be enabled to advance to the next submode (in any region) (for single
linear modes)
The inward yaw switch may be enabled to advance to the next submode (in any region) (for dual linear
modes with reflux disabled)
The inward yaw switch may be enabled to advance to the next submode (in Region2/3) (for dual linear
modes with reflux enabled)
Ultrasound Tuning
The ultrasound handpiece must be tuned with the needle installed before using. Select Prime and Tune on the
Setup Screen.

Description of Ultrasound Modes

The application of ultrasound power may be fixed or linear. Linear power is proportionally controlled by the
footpedal between zero and the maximum limit set on the console.
Ultrasound power may be adjusted from 0% to 100% in 5% increments using the up/down spin buttons, Foot
Control buttons, or remote, and 1% increments using the keypad. The ultrasound output will be activated at the
minimum programmed power level as the footpedal moves into the active ultrasound region, and will increase to
the maximum programmed output as a function of linear footpedal travel.
Single Linear Ultrasound Mode with Fixed Aspiration

programmed), an increase in footpedal resistance will be noted signifying the transition from Region1 to
Region2 and the start of aspiration. Fixed aspiration will be developed at the selected aspiration level. The
screen will display the actual amount of aspiration at any given time.
Ultrasound power is activated in Region3 of footpedal travel. Another momentary increase in footpedal
resistance will be noted (if detents are enabled) signifying the transition from one Region to the next, and the
start of ultrasound power. Ultrasound power will be initiated and controlled as a function of footpedal travel in
Region3. The next ultrasound submode may be selected (if enabled) by moving the footpedal in the outward
yaw direction.
Single Linear Ultrasound Mode with Linear Aspiration

Region2 and the start of aspiration. Aspiration will increase from 0 to the fixed level in proportion to footpedal
travel in Region2. The screen will display the actual amount of aspiration. Aspiration will remain at the fixed
level in Region3.
resistance will be noted signifying the transition from one region to the next, and the start of ultrasound power.
Linear ultrasound power will be initiated and controlled as a linear function of footpedal travel in Region3.
Pulsed ultrasound may be toggled on/off by moving the footpedal in the outward yaw direction.
Note: If single or multiple burst mode is selected, position3 (or outward yaw movement) does not
control ultrasound power, but rather the burst interval (for multiple burst) or nearly full travel
initiates and resets the single burst (see page4-23).

Dual Linear Ultrasound Mode with Aspiration in Yaw (Fixed Minimum

Vacuum in Region2)
Region2 and the start of aspiration. The minimum set aspiration will be developed in Region2. Linear
aspiration to the maximum setting will be controlled by outward yaw footpedal travel. The screen will display
the actual amount of aspiration.
Linear ultrasound power will be initiated and controlled as a linear function of footpedal travel in Region3 (see
note).
Dual Linear Ultrasound Mode with Aspiration in Yaw and Linear

Aspiration (Linear Vacuum in Region2)
Region2 and the start of aspiration. Aspiration will increase from zero to the minimum level in proportion
to footpedal travel in Region2. Linear aspiration to the maximum setting will be controlled by outward yaw
footpedal travel. The screen will display the actual amount of aspiration.
Linear ultrasound power will be initiated and controlled as a linear function of footpedal travel in Region3.
Note: If single or multiple burst mode is selected, position3 (or outward yaw movement) does not
control ultrasound power, but rather the burst interval (for multiple burst) or nearly full travel
initiates and resets the single burst.
Dual Linear Ultrasound Mode with Aspiration in Pitch

Irrigation is activated by Region1 of footpedal travel. As the footpedal travels through Region1, the irrigation
pinch valve will open to apply irrigation to the eye.
Aspiration is activated by Region2 of footpedal travel.A momentary increase in footpedal resistance will
be noted signifying the transition from Region1 to Region2, and the start of aspiration. In Region2, linear
aspiration will be developed at the selected aspiration level. The screen will display the actual amount of
aspiration.
Linear ultrasound power will be initiated and controlled as a linear function of outward yaw footpedal travel in
position2.

Dual Linear Ultrasound

Dual Linear Ultrasound mode allows control of two ultrasound parameters, one on pitch and one on yaw. In
these modes, position one provides irrigation, position two provides fixed aspiration or fixed aspiration with
aspiration control feature enabled, and position3 pitch and yaw movements provide linear control of two
ultrasound parameters. Modes are available for controlling power and pulse rate (pulsed), power and duty cycle
(pulsed), duration and duty cycle (multiple burst), power and duration (multiple burst), and power and duty
cycle (multiple burst).
Phacoemulsification Setup
WARNING: Never intentionally modify handpieces or tips, such as do not bend, cut or engrave, as they
could break or malfunction.
WARNING: Do not touch an activated ultrasonic handpiece tip as injuries could occur.
WARNING: A loose needle may lead to improper tuning and could cause shedding of metal fragments into
the eye, which can result in serious permanent patient injury.
injury.
Note: Do not use StellarisPC Vision Enhancement System posterior or combined packs on a Stellaris
system.
Note: The ultrasound handpiece, needle, and irrigation sleeve must be sterilized before performing
these steps.
a. Turn Power on.

b. Press any button on the Foot Control and wait until the right light turns solid green indicting wireless
e. After vacuum test or cartridge calibration completes, the Setup Screen will appear with Prime and
Tune as the highlighted function.
f. Spike the Balanced Salt Solution bottle and hang it at the desired bottle height.
g. Connect tubing to phaco handpiece. Select Show Me Steps for animated setup guide if necessary.
h. Plug handpiece connector to the machine (Second connector from the top).
i. Thread and firmly secure the ultrasound needle onto the ultrasound handpiece using a needle wrench.
j. Thread the irrigation sleeve over the ultrasound needle so that the holes in the irrigation sleeve are
placed approximately 1mm from and perpendicular to the bevel of the ultrasound needle (increase to
approximately 1.5mm for denser cataracts)
Irrigation Sleeve
Needle
k. Ensure the irrigation clamp is open and select irrigation Off to turn flow on, and allow the flow to fill
the irrigation tubing up to the handpieces. See page4-5 for details on the irrigation flow button (activate
the Fill button with turn flow on for 20seconds).
l. Fill the test chamber with irrigating solution, then slide over the tip of the handpiece.
m. Select Prime and Tune. A vacuum test is part of the priming cycle.
n. After successful priming and tuning, the Main Surgical Screen will appear.
The external components of your system are now ready. Continue to set the operating parameters.

Phacoemulsification Operation
Note: During any ultrasonic procedure, metal particles may result from inadvertent touching of the
ultrasonic tip with a second instrument. Another potential source of metal particles resulting
from any ultrasonic handpiece may be the result of ultrasonic energy causing micro abrasion of
the ultrasonic tip.
Note: The ultrasound needle must be properly installed and not defective, and the irrigation and
aspiration lines must be properly connected.
Note: Hold the handpiece tip towards the ceiling while priming the irrigation line to insure all air has
been removed.
You have connected the external components of your Vision Enhancement System. Now you are ready to set the
operating parameters.
a. From the Main Surgical Screen, select the desired surgical mode from the clock menu.
b. Use the spin control buttons to set the desired aspiration level, and the ultrasound maximum power. Set
the desired number of PPS for pulsed ultrasound.
Note: Assure all air bubbles are cleared from lines during priming. Once the system has been primed,
ultrasound tuning will begin automatically, and ultrasound tone will sound. When complete, the
Main Surgical Screen will appear.
Note: As a matter of operator convenience, priming is automatically canceled when tuning has been
completed or canceled. Re-tune if either the handpiece or ultrasound needle is changed.
c. Press the footpedal to begin ultrasound operation. Aspiration and ultrasound power will be applied as
the footpedal enters their pre-programmed regions (as described in Chapter3).
d. The Actual Vacuum displays the vacuum being used in relation to the maximum setting. The Actual
U/S progress bar displays amount of ultrasound power being used in relation to the maximum setting.
The Elapsed Time display indicates the time in minutes and seconds that ultrasound power has been
energized.

4.10. Coagulation Function
WARNING: Check the coagulation power level when changing between extraocular and intraocular
cauterization.
WARNING: Use only bipolar handpieces and cables designated by Bausch+Lomb for use with this
system.
WARNING: Failure of HF surgical equipment could result in an unintended power output increase.
CAUTION: The patient leads should be positioned in such a way that contact with the patient or other
leads is avoided. Temporarily unused bipolar handpieces should be stored in a location that is
isolated from the patient.
CAUTION: All bipolar accessories must be rated for an operating voltage of at least 120V.
Note: When the device and physiological monitoring equipment are used simultaneously on the
same patient, any monitoring electrodes should be placed as far as possible from the surgical
electrodes. Needle monitoring electrodes are not recommended. In all cases, monitoring
systems incorporating high frequency current limiting devices are recommended.
Note: The output power selected should be as low as possible for the intended purpose.
Note: No neutral electrode is required for use of the bipolar function.
Note: For explanation of Dual Linear Foot Control see page2-29.
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.
Coagulation modes available are:

Fixed coagulation modeProvides an adjustable output between 0% and 100%. Power levels are set
via spin button control. Fixed coagulation may be actuated by any Foot Control button, if programmed.
Fixed coagulation remains activated as long as the button remains depressed.
Linear coagulation modeProvides an adjustable output between 0% and 100%. Power levels are
set via spin button control. Linear Coagulation is selected from the clock menu on the Main Surgical
Screen. Linear coagulation is actuated by depressing the footpedal, if it has been programmed to
provide linear control as a function of angular footpedal displacement.

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 Chapter5 for cleaning and sterilization requirements when surgery is completed. Specific
instructions for cleaning and sterilization included with the handpiece or accessory take
precedence over these instructions.
B Adapter
2-Pin Connector-Style
A
Lemo Connector
a. Connect the desired bipolar forceps or pencil to its cable. You may need to use an adapter.
b. Connect the bipolar cable to the coagulation connector.
c. Use the spin buttons to adjust the percentage of coagulation power desired.
d. The fixed coagulation function is activated by pressing the programmed Foot Control switch. When the
switch is released, the function will deactivate. Fixed coagulation mode is accessible during the system
setup.
e. If programmed, a tone will signify bipolar coagulation operation.

Linear Coagulation Setup and Use
WARNING: Assure the handpiece and accessories are sterilized before use as specified.
Note: Due to compliance with IEC60601-2-2, position1 will not start until approximately 35% of
pedal travel is attained in the linear coagulation mode.
B Adapter
2-Pin Connector-Style
A
Lemo Connector
a. Connect the desired bipolar forceps or pencil to its cable. The use of an adapter may be necessary.
b. Connect the bipolar cable to the coagulation electrical connector, if required.
c. Select Coag from the clock menu.
d. Use the spin buttons to adjust the Max Coagulation power desired.
e. The linear coagulation function is actuated by the footpedal, if programmed. The Actual Coagulation
progress bar will display the amount of coagulation power being used in relation to the maximum
setting.
f. A tone will signify bipolar coagulation operation if programmed.

4.11. DigiFlow Pressurized Infusion Function
WARNING: When using Pressurized Infusion with Balanced Salt Solution bottle hung on the system
automated I/V pole, the actual intraocular pressure will be higher than the air pressure
displayed in the machine. The actual intraocular pressure would be equal to air pressure
combined with hydrostatic pressure created from the gravity force.
Note: Specific instruction for cleaning and sterilization included with the handpiece or accessory take
precedence over these instructions.
Note: Once pressurized infusion pump is turned ON, it will continue to operate even when the function
is removed from the screen display.
Note: When using pressurized infusion, hang the bottle so that the drip chamber is close to the patient
eye level.
The Pressurized Infusion function infuses a preset air pressure to pressurize the Balanced Salt Solution bottle.
The pressure generated would force Balanced Salt Solution into the eye to maintain a preset intraocular pressure
(IOP). The air pressure is generated by a compressor in the system and air is infused into the bottle through
air tubing. The use of Pressurized Infusion function would replace the gravity infusion that depends on bottle
height. The preset air pressure may be adjusted from the system screen display.
Pressurized Infusion is an optional function of Stellaris. The function could be built into the system according
to the customer order or the function could be added into existing field systems with an upgrade. A zero level
bottle hanger (BL4363) is an optional accessory that allows the Balanced Salt Solution drip chamber to be level
with the aspiration port.

Enable Pressurized Infusion Function

If system is installed with Pressurized Infusion software, the function could be enabled from surgeon file
programming or surgical More Screen.
To enable Pressurized Infusion Function from surgical More Screen:
1. Ensure surgical screen Format2 is displayed.

2. Select fluidic More Screen button (A double arrow up button below the vacuum preset display.)
3. Select Infusion Tab of the pop up screen.
4. Select Pressurized Infusion to Enabled. See diagram below.
Pressurized Infusion
Enabled/Disabled
Infusion Pump On/Off
5. Selecting Infusion Pump to On will automatically activate the air pump whenever the surgeon file is
selected for surgery.
6. Pressurized Infusion settings and function could be saved with Case More Screen.

Pressurized Infusion Setup

1. Remove the filter cap (A) from the bottle spike venting port that comes with the system disposable pack
in Figure1.
2. Connect the Air Tubing Line male connector to the bottle spike venting port (A) in Figure2.
3. Connect the Air Tubing Line filter to the microsurgical system air source (B) in Figure2.
4. Spike and hang the bottle on the hanger at the desired bottle height.
5. Use the up and down arrows to select the desired air pressure.
6. Turn On the air pump by selecting Off button below the setting display. Selecting the same button will
turn off the pump.
Figure 1 Figure 2
A
B
B
Note: Pressurized Infusion air pump could be programmed to default pump status to On. If
programmed to default On, the pump will turn on automatically when the surgeon technique
file is selected.


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: Specific instructions for cleaning and sterilization included with any handpiece or accessory

5.1. Stellaris Vision Enhancement System Routine

Cleaning
WARNING: Disconnect AC power before cleaning the system.
CAUTION: To preserve the surface finish, avoid the use of abrasive cleaners. If possible, clean spots
before they dry.
Bausch+Lomb tested the following products, and found that they can be used on all external surfaces of the
Stellaris Vision Enhancement System. Use of any substance not listed is at the users own risk.
Isopropyl alcohol (70%)

Mild soap and water
You should wipe the external surfaces of the Stellaris Vision Enhancement System, Foot Control and remote
control with a soft cloth moistened with cleaning solution on a weekly basis, while the Stellaris Vision
Enhancement System is disconnected from any power supply. Avoid applying any cleaner directly to the display
(apply to cloth sparingly). Remove all traces of the cleaning solution with a cloth dampened with clean water,
and dry the surfaces with a lint-free cloth.
If the system has an Advanced Vacuum Fluidics module, you should clean the fluid level detection lens every
three months with a 4x4in. gauze pad and isopropyl alcohol.
Gently swab the electrical connectors with an alcohol swab weekly, taking care to avoid excessive quantities of
cleaning solution around the ports. Do not reconnect to power until the ports have completely dried.

5.2. Bipolar Coagulation Accessories
WARNING: The coagulation accessories should not be sterilized using a cold soaking solution.
WARNING: Allow 20minutes after sterilization for the handpiece and cord to cool before using them
again. The handpiece connector must be completely dry before it is connected it to equipment.
CAUTION: All bipolar accessories must be rated for an operating voltage of at least 120V.
Note: No neutral electrode is required for use of the bipolar function.
The bipolar coagulation forceps, eraser, and reusable cord should be inspected before each use for signs of
misalignment, pitting, contamination (blood, tissue, etc.), or other damage. Blood, saline, tissue, and other
contamination on the tips may be removed by gently scraping with a scalpel blade. If the forceps are dropped
and seriously misaligned, or if deep pits or scores appear on the tips after long use, the forceps may be returned
to Bausch+Lomb for repair, refinishing, or repotting of the insulating base. With the exception of flash
methods, the items may be wrapped in a surgical towel, CSR wrap, or equivalent.
Wipe the forceps using a soft cloth moistened with a mild soap water solution. Avoid excessive quantities of
solution around the electrical connector. Remove all traces of the solution with a cloth dampened with clean
water. The surfaces should then be dried with a lint-free cloth.
The forceps and reusable cables may be sterilized as follows:
Standard Gravity Steam Sterilization: Wrapped for 30minutes at 121C/104.8kPa [1.048bar]

(250F/15.2psi).
Flash Sterilization: Unwrapped but covered for 10minutes at 132C/186.8kPa [1.868bar]
(270F/27.1psi).
High Vacuum (Pre-vacuum) Sterilization: Wrapped for 3minutes at 134C/206.8kPa [2.068bar]
(274F/30.0psi).
Refer to ANSI/AAMI ST79-2006, Comprehensive Guide to Steam Sterilization and Sterility Assurance in
Health Care Facilities, and/or your institutions policies regarding restrictions on the use of flash sterilization.

5.3. Advanced Flow Fluidics Transducer

The transducer should be cleaned on a weekly basis. Refer to figure 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.
C. Use an absorbent sponge (SuperSorbTM sponge) moistened with isopropyl alcohol to remove
contaminant or saline from the transducer surfaces shown.
D. Use a dry absorbent sponge to remove moisture from the transducer surfaces.
Note: Transducer must be thoroughly dry before using this function.

5.4. Irrigation and Irrigation/Aspiration Handpieces
CAUTION: Use only warm (30C to 40C or 85F to 105F) distilled or deionized water to flush the
handpiece.
The handpiece must be cleaned and autoclaved before it is placed into service the first time, before initial use
each day, and between each use in accordance with the following instructions.
Handpiece Cleaning Instructions

A. Disconnect the tubing and remove the irrigation sleeve.
B. Place the end of the syringe into a beaker of warm (30C to 40C or 85F to 105F) distilled or
deionized water, and fill the syringe to the 50cc (ml) mark.
C. Connect the end of the syringe to the irrigation fitting of the handpiece (see figure5.2).
D. Push on the syringe plunger to force fluid through the handpiece into another beaker for proper disposal.
Do not draw flushing fluid back through the handpiece. Disconnect the syringe.
E. Repeat Steps B through D at least three times.
Aspiration Flusing
Irrigation Flushing
Figure 5.2
Irrigation/Aspiration Handpiece Flushing Setup
1. Handpiece
2. Male luer
3. 3-way stockcock
4. Syringe
5. Luer adapter
6. Female luer
F. Fill the syringe with air, reattach to handpiece, and push on the syringe plunger to force air through the
handpiece. Disconnect the syringe.
G. Repeat Step F at least three times.

H. Refill the syringe to the 50cc (ml) mark with warm (30C to 40C or 85F to 105F) distilled or
deionized water.
I. Connect the syringe to the center stopcock fitting.
J. Rotate the stopcock lever to allow fluid flow to the female luer fitting.
K. Connect the stopcock female luer fitting to the handpiece aspiration fitting.
L. Push on the syringe plunger to force fluid through the handpiece into another beaker for proper disposal.
M. Repeat Steps H through L at least three times.
N. Fill the syringe with air, reattach to stopcock, and push on the syringe plunger to force air through the
O. Repeat Step N at least three times.
handpiece.

Irrigation and I/A Handpiece Sterilization
WARNING: After sterilization allow 20minutes for the handpiece to cool before it is used.
WARNING: Do not cold sterilize the instrument. The sterilizing solution may not be flushed out prior to
surgery and could be flushed into the eye, resulting in serious eye injury.
The handpiece and any reusable accessories must be autoclaved before any item is used. With the exception
of flash sterilization, the items may be wrapped in a surgical towel, CSR wrap, or equivalent. The minimum
requirements for sterilization are:

(250F/15.2psi).
(270F/27.1psi).
(274F/30.0psi).

5.5. Phacoemulsification Handpiece and Accessories

The ultrasound handpiece, reusable accessories, and cord should be inspected before each use for signs of
contamination, or other damage. If the handpiece, its cord, or any reusable accessory show signs of damage
or cracked insulation, it should not be used. The handpiece must be flushed clean and autoclaved before being
placed into service the first time, before initial use each day, and after each use in accordance with the following
instructions:
Note: Use compressed, filtered medical grade air (medical grade nitrogen) to blow out the handpiece
lumens. The pressure should not exceed 29psi (200kPa, 2bar).
Note: To maintain flexibility and prevent cable damage, wind the cord only loosely if needed, and do
not store it coiled with a less than 6 diameter.
Note: Remove the rubber plugs from the tip of the handpiece (one plug) and lumen ports (two plugs) at
the end of the handpiece before autoclaving and placing into service for the first time.
Handpiece Cleaning Instructions

Bausch+Lomb recommends the use of the Universal Maintenance Kit CX7120 in the following instructions.
The irrigation sleeve, needle, and tubing must be removed from the handpiece before beginning.
A. Remove the silicone irrigation sleeve and the needle. Remove any tubing from the rear of the handpiece.
See figure below. Rinse the exterior of the handpiece by holding it under cold running tap water for
fifteen seconds, rotating the handpiece to expose all surfaces to the flowing water.
B. Wipe the handpiece using a soft cloth moistened with a mild soap water solution. Avoid excessive
quantities of solution around the electrical connector. Remove all traces of the solution with a cloth
dampened with clean water. The surfaces should then be dried with a lint-free cloth.
Note: For users in the United Kingdom, please refer to page5-12 for special cleaning and sterilization
instructions before proceeding.

Irrigation Port
Needle
Aspiration Port
Needle Sleeve Power Cord
handpiece.
Note: You may use filtered compressed medical grade air (medical grade nitrogen) to blow out the
tubing. The pressure should not exceed 29psi (200kPa, 2bar).
C. Flush the irrigation lumen as follows (see figure below):

1. Place the end of the syringe into a container of warm (30C to 40C or 85F to 105F) distilled
or deionized water, and fill the syringe to the 50cc (ml) mark.
2. Connect the end of the syringe to the infusion line on the phaco handpiece.
3. Push on the syringe plunger to force fluid through the handpiece into another container for proper
disposal. Do not draw flushing fluid back through the handpiece. Disconnect the syringe.
4. Repeat Steps1 through 3 at least three times.
5. Fill the syringe with air, reattach to infusion line, and push on the syringe plunger to force air
through the handpiece. Disconnect the syringe.
6. Repeat Step5 at least three times.

Syringe
Handpiece
D. Flush the aspiration lumen as follows (see figure below):

1. From the rear of the handpiece, insert aspiration brush (provided in the CX7120 Universal
Maintenance Kit) into the aspiration fitting.
2. Push the brush bristles through the handpiece aspiration lumen, then pull the brush back out.
Clean the brush after each use and sterilize at the end of each day according to the maintenance kit
instructions.
3. Refill the syringe to the 50cc (ml) mark with warm (30C to 40C or 85F to 105F) distilled or
deionized water.
4. Connect the syringe to the center stopcock fitting.
5. Rotate the stopcock lever to allow fluid flow to the female luer fitting.
6. Connect the stopcock female luer fitting to the handpiece aspiration fitting.
7. Push on the syringe plunger to force fluid through the handpiece into another beaker for proper
disposal. Do not draw flushing fluid back through the handpiece. Disconnect the syringe.
8. Repeat Steps3 through 7 at least three times.
9. Fill the syringe with air, reattach to stopcock, and push on the syringe plunger to force air through
the handpiece. Disconnect the syringe.
10. Repeat Step9 at least three times.

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 page5-5.
B. Clean the needle in the same manner that the handpiece was cleaned in Steps C and D above.
C. Remove the irrigation sleeve and needle from the handpiece.

Phacoemulsification 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.
WARNING: Do not cold sterilize the instrument. The sterilizing solution may not be flushed out prior to
surgery and could be flushed into the eye, resulting in serious eye injury.
WARNING: Allow 20minutes after sterilization for the handpiece and cord to cool before using them
again. The handpiece connector must be completely dry before it is connected it to equipment.
The handpiece, needle and irrigation sleeve must be sterilized before use. With the exception of flash
sterilization, the items may be wrapped in a surgical towel, CSR wrap, or equivalent.
The minimum requirements for sterilization are:
Note: For users in the United Kingdom, please refer to page5-12 for special cleaning and sterilization
instructions before proceeding.

(250F/15.2psi).
(270F/27.1psi).
(274F/30.0psi).
5.6. Special Instructions for United Kingdom Users

Flush aspiration lumen (phaco) as follows (see figure on page5-10):
A. Place the end of the syringe into a beaker of warm (30C to 40C) distilled or deionized water, and fill
the syringe to the 50cc (ml) mark.
B. Connect the syringe to the center stopcock fitting.

C. Rotate the stopcock lever to allow flow to the female luer fitting.
D. Connect the stopcock female luer fitting to the handpiece aspiration fitting.
E. Push on the syringe plunger to force fluid through the handpiece into another beaker for proper disposal.
F. Repeat Steps A through E at least three times.
G. Prepare a neutral pH detergent solution using warm distilled or deionized water, per the detergent
manufacturers labeling instructions.
H. Immerse aspiration brush (part of CX7120 Universal Maintenance Kit) into the detergent solution
sufficiently to cover all of the brush bristles.
I. From the rear of the handpiece, insert aspiration brush into the aspiration fitting.
J. Push the brush bristles through the handpiece aspiration lumen several times. Care must be taken not to
create an aerosol effect by pushing the bristles past the end of the handpiece. Then pull the brush back
out. Thoroughly clean the brush after each use and sterilize at the end of each day according to CX7120
Universal Maintenance Kit instructions.
K. Rinse both ends of the handpiece aspiration lumen. Holding the handpiece downward at a 45 angle, and
rinse the aspiration fitting with warm (30C to 40C) distilled or deionized water. Repeat this process
for the front of the handpiece.
L. Wipe each end of the handpiece with clean gauze to remove any deposited protein material.
M. Refill the syringe with 50cc (ml) of warm distilled or deionized water.
N. Connect the end of the syringe to the center stopcock fitting.
O. Rotate the stopcock lever to allow fluid flow to the female luer fitting.
P. Connect the stopcock female luer fitting to the handpiece aspiration fitting.
Q. Push on the syringe plunger to force fluid through the handpiece into another beaker for proper disposal.
R. Repeat Steps M through Q at least four times.
S. Fill the syringe with air, reattach to stopcock, and push on the syringe plunger to force air through the
T. Repeat Step S at least three times.
U. Sterilize the handpiece as follows:
High Vacuum (Pre-vacuum) Sterilization: Wrapped for a minimum of 3minutes at 134C,
0C./+3C/206.8kPa.
Refer to your institutions policies regarding restrictions on the use of sterilization.
Automated Cleaning
1. Inspect the Stellaris Vision Enhancement Systems Phacoemulsification Handpiece to ensure that it
is free of any gross soiling or debris. If gross soiling or debris is evident, manual pre-cleaning with a
neutral pH detergent or a disposable cloth or paper wipe while wearing appropriate personal protective
equipment may be necessary. It is recommended that the Stellaris Vision Enhancement Systems
Phacoemulsification Handpiece be reprocessed as soon as is reasonably practical following use.

2. Connect the lumens of the Stellaris Vision Enhancement Systems Phacoemulsification Handpiece
to the lumen connectors or adaptors of the washer to allow detergent and rinse water to circulate freely
through the lumens of the Stellaris Vision Enhancement Systems Phacoemulsification Handpiece.
3. Ensure that the Stellaris Vision Enhancement Systems Phacoemulsification Handpiece is
placed within the washer such that all surfaces of the Stellaris Vision Enhancement Systems
Phacoemulsification Handpiece components are accessible to the detergent and rinse water during
cleaning and the Stellaris Vision Enhancement Systems Phacoemulsification Handpiece does not
move about excessively during cleaning.
4. Process the Stellaris Vision Enhancement Systems Phacoemulsification Handpiece according to the
conditions listed below. Cleaning times and conditions may be adjusted based on the degree of soiling
present on the Stellaris Vision Enhancement Systems Phacoemulsification Handpiece. The conditions
indicated below were validated using a neutral pH detergent (Getinge Neutrawash) and a severe organic
soil challenge (BS 2745: Part 3: 1993). The use of a neutral pH detergent solution is recommended
to avoid damage to the Stellaris Vision Enhancement Systems Phacoemulsification Handpiece
components.
Phase Time Temperature

Pre-Wash 3minutes 30C (86F)
Wash 11 10minutes 40C (104F)
Wash 21 10minutes 30C (86F)
Rinse 3minutes 30C (86F)
Heated Final Rinse 50minutes at 80C (176F) or 10minutes at 90C (194F)2
Drying By observationDo not exceed 110C (230F)3
1
Neutral pH detergent. Adjust concentration according to the detergent manufacturers
directions regarding water quality and the extent of instrument soiling.
2
Minimum exposure conditions for thermal disinfection using purified water.
3
As cleaning frequently involves mixed instrument loads, the efficacy of drying will vary based
on the equipment employed and the nature and volume of the load being processed. Therefore,
the drying parameters selected must be determined by observation.
5. Following processing carefully inspect the Stellaris Vision Enhancement Systems

Phacoemulsification Handpiece for cleanliness, any evidence of damage, and proper operation. If
residual soiling is apparent, reprocess the Stellaris Vision Enhancement Systems Phacoemulsification
Handpiece as indicated above.
5.7. Cleaning the MMC
CAUTION: To preserve the chassis finish, avoid the use of abrasive cleaners. If possible, clean spots
before they dry.

WARNING: Disconnect AC power before cleaning the chassis.
The following cleaning solutions are recommended to clean the MMC.
Isopropyl alcohol (70%)

Mild soap and water
Wipe the area to be cleaned using a soft cloth moistened with cleaning solution. Avoid excessive quantities of
cleaning solution around the open vents on the MMC outer chassis. Remove all traces of the cleaning solution
with a cloth dampened with clean water. The surfaces should then be dried with a lint-free cloth.
A periodic visual inspection of the system components should be performed to inspect for damaged cables or
connectors.
Store the MMC in a dry and clean area and avoid extreme temperatures.
There are no requirements for periodic calibration or adjustments.

5

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 flammable anaesthetics, disinfectants, aerosol sprays, or in an
WARNING: All external wiring must be in accordance with local electrical code requirements and NEC
Class II signaling system twisted wire with outer shield. The wire length must not exceed
20meters (60feet). The wire gage must be 26AWG to 12AWG gage, with ends stripped
from 9mm to 10mm (3/8inch). At no point should the wire be untwisted more than 5cm
(2inches).

6 Setup
6.1. Setup Instructions

Before unpacking, inspect all packages for damage. Report any damage from shipping to the carrier. Before
discarding packaging material, assure all parts are accounted for. Smaller parts may be attached to packing
materials.
6.2. Connections and Setup

The Stellaris Vision Enhancement System is pre-configured at the factory to minimize setup and installation
requirements. The following information explains the connections for the Foot Control, power cable and MMC
(optional).
Power Cable
a. Connect the power cable at the bottom rear of the system.
Fuse holder Main Power Switch

Ethernet Port
Power Cord Retention Clip Power Cord Input

Foot Control Backup Cable Port

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.
Foot Control
The Foot Control can use either wired or wireless communication. The first time the Stellaris Vision
Enhancement System is used, you must use the wired connection to establish communication between the Foot
Control and the Stellaris Vision Enhancement System.
For wired communication, connect the Foot Control backup cable from the back of the Foot Control to the
lower back of the Stellaris Vision Enhancement System.
Note: The out-of-factory Wireless System Setup is Disabled. Software upgrade will also reset the
Wireless System Setup to Disabled. To setup wireless operation, follow steps of Wireless Foot
Control Operations System Setup a section provided in Chapter2.
WARNING: For optimum aspiration and reflux performance, the patients eye must be at the same level as
the Stellaris Vision Enhancement System aspiration port. If this is not possible, use the patient
eye level offset feature in the programming screen.
To set up the Stellaris Vision Enhancement System:
a. Plug the power cord into the wall.

b. Turn on the power switch, located on the back of the bottom of the system console, and wait for
animation to finish.
c. Connect the Foot Control backup cable to the system to initiate wireless operation.
d. The battery in the Foot Control must charge at least overnight before it can be used wirelessly. To
charge the battery, you can use one of three methods. See page2-21. To use the system immediately, use the
provided cable to connect the Foot Control directly to the Stellaris Vision Enhancement System.
e. If you purchased the MMC, see page6-4 for setup details.
6.3. Multimedia Center (MMC) (optional accessory)

The Multimedia Center (MMC) is used to overlay the surgical parameters output from the Stellaris Vision
Enhancement System to the video image of the surgical site captured by the operating microscope camera. The
combined image is output to a video monitor and/or a video recorder to be displayed and stored for future use.

6 Setup
The MMC is NOT intended for diagnostic purposes.
Installation
1. Assure all equipment is turned off before making any connections. Position the MMC (L) on a flat
surface near the video monitor and/or recorder to be used.
WARNING: The MMC is not to be placed inside the patient environment.
CAUTION: Do not place the MMC on devices that radiate heat.
CAUTION: The MMC may be damaged if fluids are spilled on the outer enclosure.

6 Setup
Internet/Intranet
Connection
L
D
B
AC Electrical
Power Source
MMC
E Optional Connection
Video Camera Without Recording Device
(Not Supplied)
G
Monitor
(Not Supplied) H
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.
3. Connect the video input cable (D) from the surgical microscope camera to the VIDEO IN connector (use
the included RCA Plug to BNC Jack adapter if necessary) or S-VIDEO IN connector of the MMC (L).
WARNING: The surgical microscope camera must be medical grade.
Note: The VIDEO IN connector requires that the camera output impedance be set to NORMAL or
75OHMS if the camera has a switch setting or adjustment for output impedance.

6 Setup
4. Using the video output cable (E) provided with the MMC, connect the COMPOSITE VIDEO OUT or
S-VIDEO OUT from the MMC (L) to the user supplied video monitor (H). If desired, the video cassette
recorder (G) (per manufacturers instructions for that equipment) may be connected between the MMC
and monitor using user supplied cables. Use the included RCA Jack to BNC Plug adapter if necessary.
The video monitor must be connected to the MMC before the MMC is powered up. If the MMC is
powered up with no monitor or recorder connected, the video output with the overlay may not appear.
The MMC must be powered down and powered up again with the monitor connected.
Note: The COMPOSITE VIDEO OUT output must be used if the input video signal is connected via
the COMPOSITE VIDEO IN connector. The S-VIDEO OUT output must be used if the input
video signal is connected via the S-VIDEO IN connector.
WARNING: The VCR and/or Monitor connected to the MMC must be medical grade or plugged into a
medical grade isolation transformer.
5. Attach the Ethernet cable on the back of the Stellaris Vision Enhancement System Computer Unit
(J). Attach the other end of the data communications cable to the Ethernet connector of the MMC (L)
labeled with the Stellaris icon.
WARNING: Connecting the MMC data communication cable to equipment other than the Stellaris Vision
Enhancement System may cause damage to both systems.
6. Turn on the microscope camera and the video recorder and/or monitor.
7. Verify that the image captured by the surgical microscope camera is displayed on the video monitor.
With the MMC powered off, the MMC is operating in a video bypass mode; thus the video input is
directly connected to the video output.
8. Turn on the MMC by pressing the power on/off switch. The power indicator on the MMC front panel
will change from a bright blue to a dimmer blue.
Note: Allow the MMC to stabilize to room temperature before energizing.
9. After approximately one minute, verify that the Bausch+Lomb logo appears in the lower right corner
of the video image on the monitor.
10. Turn on the Stellaris Vision Enhancement System as directed in Chapter1. The Stellaris Vision
Enhancement System mode and settings information will not be displayed until a surgical mode is
entered.
11. Verify that the Stellaris Vision Enhancement Systems mode and setting information is overlaying the
video image from the microscope camera on the video monitor.

6 Setup
Video Capture
The MMC has FireWire DCAM output capability, which can be used to send video to a personal computer
for video capture. To take advantage of this capability, you must install software to support your video capture
software. This software may be obtained by contacting Bausch+Lomb Global Product Support.
Note: A six foot FireWire cable is provided with the MMC module.

6 Setup

7 Troubleshooting and Maintenance
Troubleshooting and Maintenance

This chapter contains procedures for identifying and resolving problems that may occur with your Stellaris
Vision Enhancement System.
Note: Preventative scheduled maintenance is recommended once a year to insure that the Stellaris
Vision Enhancement System meets it optimum performance, reliability and safety standards set
by the manufacturer. The maintenance shall be done by a Bausch+Lomb certified individual
only.
Note: Other than main fuses, this system contains no parts that are serviceable by the user. All
maintenance shall be done by a Bausch+Lomb certified individual only.
7.1. User Troubleshooting

If the aspiration line becomes clogged, and it cannot be cleared using reflux, remove the handpiece
from the eye and clear the aspiration port of lodged material.
If ultrasound calibration fails, check connections and needle, then attempt calibration a second time. If
calibration fails twice, change to a known good handpiece and attempt to calibrate again. If a known
good handpiece fails calibration, or if assistance is needed to determine if the original handpiece is
defective, contact Global Product Support (see Chapter8).
7.2. Power Issues

If you flip the main power switch and no power is sent to the system (i.e., the stand-by power switch does
not light up, or there is no faint fan noise from the lower rear of the system, etc.), you may have a bad fuse.
First check that the rest of the operating suite has power, the cord is still plugged in, and the wall outlet is still
supplying proper power.
If the power supply chain appears to be intact, you may have a blown fuse. A blown fuse is usually noticeable
after removal from the system by obvious discoloration within the fuse and/or an obviously broken fuse-wire
within the fuse.
Fuse Replacement
The Stellaris Vision Enhancement System has 2 user-replaceable fuses. If an over-current condition should
occur which opens these fuses, they should be replaced with fuses of the same value as the original fuses (see
specifications table in Chapter9).
A blown fuse may be indicated by the following conditions:

With the system off, using a known good outlet, no power is sent to the system when you flip the main
power switch to on. (i.e., the stand-by power switch is not lit up, no faint fan noise from the lower
rear of the system, etc.).
A blown fuse is usually noticeable after removal from the system by obvious discoloration within the fuse and/
or an obviously broken fuse-wire within the fuse.
Note: If damage is apparent to either fuse, both should be replaced to ensure proper operation.
a. Remove the power cord from the Stellaris Vision Enhancement System. The presence of the power
cord will physically prevent the removal of the fuse drawer.
b. Using a flat-blade screwdriver, turn the fuse holder counter-clockwise, and pull outward. One style of
fuse holder will come partially out and the fuse will drop out. On the other style, the fuse is retained by
clips on the back.
c. Reinstall the fuse holder, and lock it by turning clockwise.
d. Snap the fuse drawer back into place.
e. Replace the cord and the system should be ready to run again.
Fuse Holder Location

7.3. Informational and Warning Messages

All messages displayed by the user interface are uniform in their appearance. However, the box will have a red
border if a safety related condition is present. When an event occurs, the system will sound a tone and display a
pop-up window with the message displayed. The pop-up window will provide the user with a choice of options
for proceeding. Nothing else may be done while a pop-up window is displayed.
Messages and suggested corrective actions are shown in the following tables.
Prefix Trouble Area

AFM Flow Fluidics Module
BPS Power Supply Module
CPX Compressor Module
EIV IV Pole Module
MMC MultiMedia Center Module
RCR Remote Control Receiver Module
UIC User Interface Computer Module
USM Ultrasound Module
VFM Vacuum Fluidics Module
WFC Foot Control Module
WFR Foot Control Receiver Module

Flow Fluidics Module Messages
ID Text Message Suggested

Action(s)
AFM01 The flow fluidics module was not detected in the system. Surgical mode SG01
with the flow fluidics module is not available.
AFM02 The flow fluidics module software version is not compatible with this SG02
software version. Surgical mode is not available.
AFM03 The flow fluidics module has failed to respond to a settings command. SG03
The module settings have been re-sent to the module. SG04
AFM04 The flow fluidics module has reset. The module settings have been re-sent SG03
to the module. SG04
AFM05 The flow fluidics module does not have valid factory calibration data. SG07
Surgical mode with the flow fluidics module is not available. SG08
AFM06 The fluidics pump motor may have failed. SG09
SG10
AFM07 The flow fluidics module cartridge vacuum sensor test has not been SG12
attempted.
AFM08 The flow fluidics module cartridge vacuum sensor test is in progress. SG14
AFM09 The flow fluidics module cartridge vacuum sensor test has failed. SG16
SG17
SG18
SG04
AFM10 The flow fluidics module vacuum sensor has failed. SG19
AFM11 System priming has not been attempted. SG20
AFM12 System priming is in progress. SG21
AFM13 System priming has failed. SG22
SG24
SG04
AFM14 The flow fluidics module vitrectomy cutter output pressure is low. SG30
Vitrectomy cutter may not be cutting. SG31
SG04
AFM16 Please insert the flow fluidics cartridge. SG80

Power Supply Module Messages

Action(s)
BPS01 The power module battery has exceeded the recommended number of SG66
charge cycles. Battery back-up of the system may not be available.
BPS02 The power supply was not detected in the system. SG01
BPS03 The power supply software version is not compatible with this software SG02
version. Surgical mode is not available.
BPS04 The power supply has failed to respond to a settings command. The SG04
module settings have been re-sent to the module.
BPS05 The power supply has reset. The module settings have been re-sent to the SG04
module.
BPS06 The power module back-up battery temperature is higher than expected. SG67
SG04
BPS07 The power module temperature is higher than expected. SG67
SG04
BPS08 The power module is at an over temperature condition. System shutdown SG67
is imminent. SG04
BPS10 The power module battery is failing to charge properly. Battery back-up SG69
of the system may not be available. SG66
BPS11 Main power input has been lost. System is running on back up battery SG81
power. Surgical functions are inhibited. System will shut down shortly if SG04
main power input is not restored.

Compressor Module Messages

Action(s)
CPX01 The compressor module was not detected in the system. Surgical mode is SG01
not available.
CPX02 The compressor module software version is not compatible with this SG02
CPX03 The compressor module has failed to respond to a settings command. The SG04
CPX04 The compressor module has reset. The module settings have been re-sent SG04
to the module.
CPX05 The air pressure output is lower than commanded. SG45
SG44
SG04
CPX06 The air pressure output is higher than commanded. SG46
SG04
CPX07 The internal air pressure system cannot reach the full pressure expected. SG31
SG25
SG04
CPX08 The internal vacuum pump has failed. SG47
SG04

IV Pole Module Messages

Action(s)
EIV01 The IV Pole controller was not detected in the system. The motorized IV SG01
Pole function is not available.
EIV02 The IV Pole controller software version is not compatible with this SG02
software version IV Pole function is not available.
EIV03 The IV Pole controller has failed to respond to a settings command. The SG04
EIV04 The IV Pole controller has reset. The module settings have been re-sent to SG04
the module.
EIV05 The IV Pole position cannot be determined. SG62
SG04
EIV07 The IV Pole is not detecting the home position switch or the IV Pole SG62
motor may have failed. SG04
EIV08 The IV Pole panel button sensors have failed or the buttons have been SG65
activated continuously since being powered on. SG64
SG04
MultiMedia Center (MMC) Module Messages

Action(s)
MMC01 The multimedia center was not detected in the system. SG74
SG73
MMC02 The multimedia center software version is not compatible with this SG02
software version. The video overlay function is not available.
MMC03 The multimedia center has failed to respond to a settings command. The SG04

Remote Control Receiver Module Messages

Action(s)
RCR01 The remote control receiver was not detected in the system. Remote SG01
control and display backlight control functions are not available.
RCR02 The remote control receiver software version is not compatible with this SG02
software version. Remote Control is not available.
RCR03 The remote control receiver has failed to respond to a settings command. SG04
The module settings have been re-sent to the module.
RCR04 The remote control receiver has reset. The module settings have been SG04
re-sent to the module.
RCR05 Possible interference with remote control receivers. Remote control SG71
function may not be available. SG70
SG04
RCR06 The remote control battery level is low. Remote control function may not SG72
be available shortly. SG71
SG04
User Interface Computer (UIC) Module Messages

Action(s)
UIC01 IV Pole height range is (0)-(1) cm. SG75
Note: (0) is IV Pole Min Value and (1) is IV Pole Max Value.
UIC02 IV Pole height range is (0)-(1) cm. SG76
Note: (0) is IV Pole Min Value and (1) is IV Pole Max Value.
UIC03 Phase/Mode change not allowed while surgical functions in use. SG77
UIC04 Initialization of surgical system failed. Surgical mode not available. SG78
SG04

Ultrasound Module Messages

Action(s)
USM01 The ultrasound module was not detected in the system. Ultrasound, SG01
coagulation, and electric vitrectomy functions not available.
USM02 The ultrasound module software version is not compatible with this SG02
software version. Ultrasound module functions not available.
USM03 The ultrasound module has failed to respond to a settings command. The SG04
USM04 The ultrasound module has reset. The module settings have been re-sent SG04
to the module.
USM05 The ultrasound handpiece is not connected or detected. SG48
SG49
SG04
USM06 The ultrasound handpiece has not been tuned. SG50
USM07 The ultrasound handpiece tuning is in progress. SG51
USM08 The ultrasound handpiece has failed the tuning process. SG53
SG52
SG04
USM09 The ultrasound handpiece may have failed or may be failing. SG54
SG53
SG04
USM10 Coagulation circuit may have failed, potential coagulation output SG56
overvoltage condition. SG55
SG04
USM11 Coagulation circuit may have failed, potential uncommanded or incorrect SG56
coagulation output. SG55
SG04
USM12 Incorrect ultrasound handpiece connected. SG57
SG04
USM13 The electric vitrectomy handpiece is not plugged in to the system. SG59
SG58
SG04
USM14 The electric vitrectomy handpiece may have failed. SG61
SG60
SG04
USM15 Unable to read ultrasound handpiece data. Attempt to tune the handpiece SG53
to confirm proper operation. SG04

Vacuum Fluidics Module Messages

Action(s)
VFM01 The vacuum fluidics module was not detected in the system. Surgical SG01
mode with the vacuum fluidics module is not available.
VFM02 The vacuum fluidics module software version is not compatible with this SG02
VFM03 The vacuum fluidics module has failed to respond to a settings command. SG03
The module settings have been re-sent to the module. SG04
VFM04 The vacuum fluidics module has reset. The module settings have been SG03
re-sent to the module. SG04
VFM05 The vacuum fluidics module does not have valid factory calibration data. SG05
Surgical mode with the vacuum fluidics module is not available. SG06
VFM06 The vacuum fluidics module cassette vacuum check has not been SG11
attempted.
VFM07 The vacuum fluidics module cassette vacuum check is in progress. SG13
VFM08 The vacuum fluidics module cassette vacuum check has failed. SG11
SG15
SG04
VFM09 System priming has not been attempted. SG20
VFM10 System priming is in progress. SG21
VFM11 System priming has failed. SG22
SG23
SG04
VFM13 The vacuum fluidics module cassette is nearly full. SG26
SG27
VFM14 The vacuum fluidics cassette is full. SG28
SG29
VFM15 The vacuum fluidics module vitrectomy cutter output pressure is low. SG30
Vitrectomy cutter may not be cutting. SG31
SG04
VFM17 Insert the vacuum fluidics cassette. SG79

Foot Control Module Messages

Action(s)
WFC01 The Foot Control battery has exceeded 300 charge cycles. SG32
The Foot Control battery may not provide power for the entire day. SG33
SG34
WFC02 The Foot Control does not have valid factory calibration data. Surgical SG34
mode is not available. SG35
WFC03 The Foot Control is programmed for right footed operation, but is set up SG36
for left footed operation. SG37
WFC04 The Foot Control is programmed for left footed operation, but is set up for SG36
right footed operation. SG37
WFC05 The Foot Control center pedal or button sensors have failed or the Foot SG38
Control has been activated continuously since being powered on. SG34
SG04
WFC08 System not detecting the Foot Control. SG40
SG33
SG34
WFC09 The Foot Control software version is not compatible with this software SG34
version. Surgical mode is not available. SG02
WFC10 Foot Control detected on wired cable connection. SG41
WFC11 Foot Control configuration on wired cable connection has completed SG42
successfully.
WFC12 Foot Control configuration on the wired cable connection has failed. SG34
SG04
WFC13 The Foot Control battery charge level is low. SG33
WFC14 The Foot Control battery is nearly discharged. SG43
SG34
WFC15 The wireless Foot Control signal quality is poor. SG43
SG34
SG33
SG04
WFC16 The Foot Control spring has failed; the Foot Control center pedal has been SG34
disabled. SG04
WFC17 The Foot Control battery has exceeded 300 charge cycles and the battery SG82
is nearly discharged. The Foot Control may stop functioning unless the SG34
battery is replaced immediately.
WFC18 System not detecting the Foot Control. SG33
SG34
WFC19 The system has lost communication with the Foot Control, wireless SG84
disabled. SG85


Action(s)
WFC20 The system has lost communication with the Foot Control. SG83
SG34
SG04
Foot Control Receiver Module Messages

Action(s)
WFR01 The Foot Control receiver was not detected in the system. Surgical mode SG01
is not available.
WFR02 The Foot Control receiver software version is not compatible with this SG02
WFR03 The Foot Control receiver has failed to respond to a settings command. SG04
The module settings have been re-sent to the module.
WFR04 The Foot Control receiver has reset. The module settings have been SG04
re-sent to the module.
Internal Application Messages

The system requires restarting due to an internal error, please perform the following:
1. Select Close to initiate system shutdown.

2. If system does not shutdown after 30seconds, power off the system by pressing and holding the power
button at the front panel.
3. Restart system after one minute.
Call your product service representative if this problem persists.

Suggested Actions for Messages
Suggestion Suggested Action Text

Action ID
SG01 Call your product service representative.
SG02 Call your product service representative. A compatible software version must be
downloaded.
SG03 Confirm correct irrigation, aspiration, and vitrectomy function.
SG04 Call your product service representative if this problem persists.
SG05 Call your product service representative to replace the vacuum fluidics module.
SG06 Call your product service representative to replace or calibrate the vacuum fluidics
module.
SG07 Call your product service representative to replace the flow fluidics module.
SG08 Call your product service representative to replace or calibrate the flow fluidics module.
SG09 Open the flow fluidics module drawer, re-insert the cartridge, and close the drawer again.
Try to observe if the pump head moves as the drawer closes.
SG10 Call your product service representative to replace the flow fluidics module if this
problem persists.
SG11 Select Setup, select Eject Cassette, and then re-insert the vacuum fluidics cassette for
the cassette vacuum check.
SG12 Select Setup, select Open Drawer, re-insert the flow fluidics cartridge, and select
Close Drawer for the cartridge vacuum sensor test.
SG13 Please wait for the vacuum fluidics module cassette vacuum check to complete.
SG14 Please wait for the flow fluidics module cartridge vacuum sensor check to complete.
SG15 Replace the vacuum fluidics cassette.
SG16 Select Setup, select Open Drawer, re-insert the flow fluidics cartridge, and select
Close Drawer for the cartridge vacuum sensor test.
SG17 Make sure that the flow fluidics module and cartridge vacuum sensor surfaces are clean
and dry.
SG18 Replace the flow fluidics cartridge.
SG19 Select Setup, select Open Drawer, and make sure that the flow fluidics module and
cartridge vacuum sensor surfaces are clean and dry. Select Close Drawer to retry the
cartridge vacuum sensor test.
SG20 Select Setup, and select Prime and Tune or Prime Only to complete the system
priming.
SG21 Please wait for the system priming to complete.
SG22 Check irrigation and aspiration tubing connections for leaks. Check that the test chamber
is forming a tight seal around the handpiece. Try priming the system again.
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 Confirm correct irrigation and aspiration function.


Action ID
SG26 Arrange the soonest convenient time to empty the cassette. To empty cassette and
reprime: 1. Clamp irrigation line. 2. Select the Setup icon. 3. Select Eject Cassette
button. 4. Empty the cassette. 5. Re-insert the cassette. 6. Open irrigation clamp. 7.
Select Prime to prime cassette. 8. After priming, select Advance to Surgery to
resume surgery. Refer to operators manual for detail instructions to detach tubing
manifold from the cassette.
SG27 Call your product service representative if the cassette is not nearly full and this message
persists.
SG28 Empty the cassette. To empty cassette and reprime: 1. Clamp irrigation line. 2. Select
the Setup icon. 3. Select Eject Cassette button. 4. Empty the cassette. 5. Re-insert the
cassette. 6. Open irrigation clamp. 7. Select Prime to prime cassette. 8. After priming,
select Advance to Surgery to resume surgery. Refer to operators manual for detail
instructions to detach tubing manifold from the cassette.
SG29 Call your product service representative if the cassette is not full and this problem
persists.
SG30 Check that the vitrectomy cutter tubing is connected tightly to the system.
SG31 Confirm correct vitrectomy function.
SG32 If the battery does not provide power for the full day, replace the battery.
SG33 Use the wired cable connection to the system.
SG34 Replace the Foot Control with another Foot Control using the wired cable connection to
the system.
SG35 Call your product service representative to have the Foot Control calibrated.
SG36 Change the Foot Control home position switch selection.
SG37 Confirm that the correct surgeon settings are loaded. If incorrect, select Setup, then
select Select Surgeon to select the correct surgeon settings.
SG38 Reposition the Foot Control and ensure that the center pedal and buttons are not
activated.
SG39 Position the Foot Control on a flat working surface.
SG40 Initiate wireless foot control connectivity by pressing one of the Foot Control buttons
momentarily, the left LED will light up.
SG41 Please wait while the Foot Control configuration completes.
SG42 You may disconnect the Foot Control cable and operate the Foot Control wirelessly.
SG43 Disconnect the Foot Control cable, Reconnect the cable and try again.
SG44 Check that the air line tubing is connected tightly to the system.
SG45 Check that there are no leaks in the air line and that the air line tubing is connected
tightly to the other pack components.
SG46 Turn the pressurized infusion pump off, wait for a few seconds, and then turn the pump
back on.
SG47 Confirm correct operation of the aspiration function.
SG48 Please plug in the ultrasound handpiece. The ultrasound connector light is flashing.


Action ID
SG49 If the handpiece is not detected, unplug the handpiece and try another ultrasound
handpiece.
SG50 Select Setup, then select Prime and Tune or Tune Only.
SG51 Please wait for the ultrasound handpiece tuning to complete.
SG52 Ensure ultrasound needle is properly tightened. Select Prime and Tune or Tune Only
again to repeat the handpiece tuning process.
SG53 Unplug the handpiece and try another ultrasound handpiece.
SG54 Confirm proper ultrasound handpiece operation in a test chamber.
SG55 Confirm proper operation of the coagulation handpiece in a beaker of Balanced Salt
Solution.
SG56 Unplug the handpiece and try another bipolar coagulation cord.
SG57 If the handpiece is not detected, unplug the handpiece and try another ultrasound
handpiece.
SG58 Please plug in the electric vitrectomy handpiece. The electric vitrectomy connector light
is flashing.
SG59 If the handpiece is not detected, unplug the handpiece and try another electric vitrectomy
handpiece.
SG60 Confirm proper operation of the electric vitrectomy handpiece in a beaker of Balanced
Salt Solution.
SG61 Unplug the handpiece and try another electric vitrectomy handpiece.
SG62 Please command the IV Pole to the minimum bottle height position.
SG64 Ensure that the IV Pole back panel buttons are not activated.
SG65 Confirm proper operation of the IV Pole back panel buttons.
SG67 Confirm that the bottom and lower rear areas of the system are not blocked from free air
flow.
SG68 Confirm proper system operation. System may not be available if needed functions
cannot be verified.
SG69 Call your product service representative if this problem persists with multiple batteries.
SG70 Turn off or dim room lights. Certain types of room lighting may cause this type of
interference.
SG71 Check remote functions with A/V pop-up display on the Remote Control tab
SG72 Replace the remote control battery at your earliest convenience.
SG73 Please ensure that the multimedia center is plugged in and powered on.
SG74 Check that the multimedia center data cable is plugged in to both the system and the
multimedia center.
SG75 IV Pole valid range is (0)-(1) cm.
SG76 IV Pole valid range is (0)-(1) cm. Go to IV Pole more screen or programming function
to reset ceiling limit.
SG77 Change Phase/Mode while surgical functions not in use.
SG78 Power down the system and then restart the system.


Action ID
SG79 Insert the vacuum fluidics cassette.
SG80 Insert the flow fluidics cartridge and press the Close Drawer button.
SG81 Check the main power input cord and ensure that the system is plugged in.
SG82 Immediately replace the battery to ensure Foot Control functionality.
SG83 Check the cable connection.
SG84 Connect the Foot Control cable to continue use.
SG85 See User Manual for re-enabling wireless communication.

Additional Troubleshooting Guide
Symptom Potential Cause Corrective Action

1 Foot Control lost Pitch The Foot Pedal Offset switch not properly Check Offset switch at
control of Region2, 3 and engaged. System not detecting if foot pedal the back of the foot pedal,
Yaw. Pitch could only is offset to Left, Right or Center. ensure switch is fully
control Irrigation On/ engaged to the Left, Right
Pedal Pitch
Off. The four side buttons Tension
or Center.
function normally. Pedal Adjustment
Offset Knob
Adjusment
Switch
Battery
Compartment
Door
2 Foot Control does not The Foot Control does not automatically Following the
automatically transition transition to wireless operation every time disconnection of backup
to wireless operation after the backup cable is disconnected. cable, initiate wireless
disconnecting the Foot Foot Control connectivity
Control backup cable. by pressing one of the
Foot Control buttons. The
right LED light would
light up within 10seconds;
indicating wireless
connection is ready.
3 System not reading cassette The cassette was not fully inserted. This Eject cassette and reinsert.
fluid level correctly. can occur if the cassette is inserted slowly
and captured in a position that affects the To ensure cassette is
performance of the fluid level sensor. properly positioned in the
system, firmly insert the
This may also occur if the cassette is inserted cassette until it snaps in
too fast and released before the capture place.
mechanism captures the cassette at the
optimum position.

Symptom Potential Cause Corrective Action

4 No or low infusion with 1. Air tubing or irrigation tubing may be Check air tubing and
Pressurized Infusion kinked irrigation tubing for kink
function. or pinch.
2. The air tubing pathway may be obstructed Ensure new air tubing is
System displays actual used. Otherwise, replace
pressure correctly and air is with new tubing.
coming out of the air output
3. Preset pressure may be set too low Increase air pressure
connector.
setting to desired level
If problem persists with
the all of the above
corrective actions, stop
using Pressurized Infusion
and call service.
5 System shutdown, cassette Power supply cut off from the source or 1. Stop surgery and
ejected and irrigation power cable is accidentally unplug from the remove handpiece from
running into cassette/ wall. the eye.
cartridge and handpiece.
2. Close irrigation clamp
to stop fluid flow into
the cassette/cartridge
and handpiece.
3. Replace test chamber

to the handpiece that is
connected to the tubing.
4. Reboot system, prime

and tune handpiece
when power supply
resumes (ensure to open
irrigation clamp before
starting to re-prime and
tune system).
6 Remote Control not Remote firmware not responding to key Reset the device by
working with good or new inputs. removing the batteries and
batteries. waiting for at least one
minute before re-installing
the batteries.

7.4. Troubleshooting the MMC

When a problem appears with the MMC, the first step in troubleshooting is to remove the MMC components
from the video setup, and then assure that the rest of the system is operating correctly.
Symptom Action Required

Video display not Check video monitor for overscan or underscan adjustments.
centered on screen
or edge off screen
No camera video Is camera powered on?
Turn the MMC off. If video is displayed, the input and output cables to the MMC are
reversed.
Check for video when camera is plugged directly into monitor.
Is video input selection correct on VCR and Monitor?
Is camera plugged into VIDEO IN or S-VIDEO IN?
No overlay logo Is MMC powered up (power indicator on)?
displayed Are power cord(s) connected correctly?
Check video connections: IN/OUT, S-Video/Video.
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 Is monitor set to correct format: NTSC or PAL?
Intermittent or Check all video cables and connections.
flickering video Is monitor set to correct format: NTSC or PAL?
Rolling video Is camera powered on?
Video format may not be supported.
Is monitor set to correct format: NTSC or PAL?
No streaming video Ethernet cable connected?
on console Camera turned on?
Check video connections Cycle power on MMC.
Cycle power on system and power up MMC.

Symptom Action Required

System modules When the problem occurs, the system will automatically turn ON the irrigation
reset momentarily valve to provide continuous irrigation. System main functions such as aspiration and
ultrasound will cease to operate.
To resume system operation, perform the following:
A. Go to Setup screen
B. Replace test chamber on the phaco handpiece
C. Select Prime and Tune
D. Following successful prime and tune, the system will go to surgical mode to
resume operation.
GUI hung up and When the problem occurs, the system will automatically turn ON the irrigation valve
system ceased to provide continuous irrigation. System and MMC need to be restarted to resume
operation operation.
To restart system, perform the following:
A. Power down system by pressing and holding the standby power switch in front
of the system
B. Wait until the system powers down completely
C. Power down MMC by pressing and holding the power switch until the light
turns brighter (if not already powered down)
D. Restart MMC by pressing the power switch
E. Restart system by pressing the standby power switch once
F. Repeat system set up sequence, Prime and Tune system to resume operation

7.5. System Configurations and Accessories

Use of non-approved accessories, packs or parts may affect system performance. The unauthorized modification
or alteration of the equipment, or the use of non-approved accessories, packs or parts with the equipment shall
relieve Bausch+Lomb from any warranty, service obligation or other liability for damages to, or failure of, the
equipment caused by such unauthorized acts.
Approved accessories will be appropriately labeled as Manufactured By, Manufactured For, or Distributed By
Bausch & Lomb. For a complete list of approved accessories please consult your local Bausch + Lomb catalog
or contact your local Bausch + Lomb representative.

Group SKU Description

System Configuration BL11110 Anterior Deluxe Advanced Vacuum System
System Configuration BL11120 Anterior Deluxe Advanced Flow System
Accessory BL3170 Ultrasound Phaco Handpiece
Accessory BL3379 Stellaris Ultrasound Handpiece Tray
Software BL6310 Remote Service Software
Software BL6320 Pressurized Infusion Software
Software BL6340 Multimedia Center Software
Miscellaneous BL4390 Foot Control Battery
Miscellaneous BL4391 Foot Control Wall Charger (without adapter)
Miscellaneous BL4392US Foot Control Charger Adapter, United States
Miscellaneous BL4392EUR Foot Control Charger Adapter, Europe
Miscellaneous BL4392UK Foot Control Charger Adapter, United Kingdom
Miscellaneous BL4392AUS Foot Control Charger Adapter, Australia
Miscellaneous BL4392ROW Foot Control Charger Adapter, Rest of World
Miscellaneous BL4393 Foot Control Charging Cradle
Miscellaneous BL4394 Foot Control Backup Cable
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 Fuses, AC Input, User Replaceable
Miscellaneous CX9400 Reusable Bipolar Cord with 2 Pin Connector
Miscellaneous CX9430 Reusable Bipolar Cord with Lemo Connector
Miscellaneous CX9404 Banana Plug Adapter, Reusable
Miscellaneous D8200 Straight Bipolar Forceps 0.5mm Tip Lemo Connector
Miscellaneous D8201 Bipolar Eraser, 31 Shaft with 45 Degree Bevelled
Lemo Connector
Miscellaneous E7918 Bipolar Pencil 18g Str 10/box
Miscellaneous S2050 B Bipolar Cord with Banana Connector (Disposable)
Miscellaneous S2050 10A Bipolar Forceps Ang McPhersonBanana Connector
Miscellaneous S2050 10S Bipolar Forceps McPherson StraightBanana
Connector

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. The maintenance shall be done by a Bausch+Lomb certified individual
only.

8.1. Service Information
Technical Assistance
Assistance for Stellaris Vision Enhancement System is available from Global Product Support either by phone
or letter as follows:
Bausch&Lomb Incorporated
3365 Tree Court Industrial Blvd.
St. Louis, Missouri 63122 U.S.A.
Attention: Global Product Support
For product support within the U.S.A. call the 24-hour telephone line 1-800-338-2020 or fax 636-226-
3070.
For product support from outside the U.S.A. either call 1-636-226-3535, send a fax to 1-636-226-
3070, or contact your local Bausch+Lomb Product Support Representative (listing of local offices
starts on page8-4).
Please organize your material before calling or writing for technical support. Please have the following
information ready:
Customer account number
Name of function, handpiece, etc. that needs service
Model number (REF #) and serial number (SN#) of Stellaris Vision Enhancement System, located on
the label on the back panel
Date of purchase
Description of problem, listing all observable symptoms and characteristics, and details of occurrence.
Was patient involved at time of occurrence?

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:
Customer account number
Customer name, address, and telephone number
Name of function, handpiece, etc. that needs service
Model number (REF #) and serial number (SN#) of Stellaris Vision Enhancement System, located on
the label on the back panel
Date of purchase
Description of the problem or service desired. List all observable symptoms and characteristics, and
details of occurrence. Was patient involved at time of occurrence?
Return authorization number assigned by our Global Product Support specialist
Contact name and phone number if additional information is required
Ship or otherwise return the part, transportation and insurance prepaid, to your local Bausch+Lomb
International Facility unless otherwise instructed.
For accessories and disposable handpieces, contact your local Bausch+Lomb representative to determine
applicable return policies for your local market.

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.
North Ryde, NSW 1670
Australia
*Tel: 61-2-9887-1444
*Fax: 61-2-9888-9642
Austria
Bausch and Lomb GmbH
Horlgasse 12 Mezzanin TOP 5
1090 Wien, Osterreich
Tel: 49-6221-823184
Belgium
Bausch&Lomb
Uitbreidingstraat 46
2600 Antwerpen Belgium
*Tel: 32-3-280-82-40
*Fax: 32-3-280-82-59
Bermuda
Bausch&Lomb Ireland/Bermuda HQ Office
Gibbons Bldg.
P.O. Box 1154
Hamilton, HM EX Bermuda
Tel: 441-295-1044
Fax: 441-292-6140

Brazil
BL Industria Otica LTDA.
Rua Dona Alzira, 139
91110-010, Porto Alegre, RS, Brazil
Tel: 55-51-3393-2000
Fax: 55-51-3393-2100
BL Industria Otica LTDA

Av Eng Luiz Carlos Berrini, 1700 -15andar
04571-000, Sao Paulo-Brazil
Tel: 55-11-3238-2900
Fax: 55-11-5506-5528
Canada
Bausch&Lomb Canada
520 Applewood Crescent
Vaughan, Ontario L4K 4B4
Canada
Tel: 905-695-7695
Fax: 905-695-7656
*Tel: 800-567-2696
*Fax: 905-578-0103
Customer service 1-800-387-3284
China
Bausch&Lomb Surgical
Room 906-909, Tower 1
No. 218, Tianmu Road (W)
Shanghai 200070
P.R. China
Tel: 86-21-6317-7143
Fax: 86-21-6354-7780

France
Bausch&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 Office)

Tel: 33-4-37-48-83-83 Reception
Fax: 33-4-37-48-83-84 Reception
Germany
Bausch&Lomb GmbH
Brunsbtteler Damm 165 - 173
13581 Berlin
Tel.: +49 6221 / 823184
Fax.: +49 6221 / 823149
Hotline (within Germany): 0800 2233331
Greece
Bausch&Lomb Greece
73 Apostolopou Street
Chalandri, 15231
Athens, Greece
Tel: 30-210-674-8170
Fax: 30-210-674-8234
*Tel: 33-4-37-48-83-83
*Fax: 33-4-37-48-83-84
Hong Kong
Bausch&Lomb Asia
15/F One Kowloon
Wang Yuen Street, Kowloon Bay
Kowloon, Hong Kong
*Tel: 85-2-2-213-3333
*Fax: 85-2-2567-8170

India
Bausch&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&Lomb-IOM S.p.a.
Via Pasubio 34
20050 Macherio
Milan Italy
Tel: 39-039-20731
Fax: 39-039-2010081
*Tel: 39-039-207-3744
*Tel: 39-039-207-3308
*Fax: 800-17-3931
Japan
Bausch&Lomb Japan Ltd.
Tower B, Omori Bellport
6-26-2, Minami-Oi, Shinagawa-ku
Tokyo 1400-0013, Japan
*Tel: 81-3-5763-3700
*Fax: 81-3-5763-4003
Korea
Bausch&Lomb Surgical
11F Cannon B/D
168-12 Samseong-clong Gangnam-gu
Seoul, Korea
Tel: 822-558-2988
Fax: 822-642-1586

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.
C.P. 05349
Tel: 52-55-30-67-4600
Fax: 52-55-30-67-4658
*Tel: 52-55-3067-4611
Netherlands
Bausch&Lomb B.V.
Koolhovenlaan 110
1119 NH Schiphol-Rijk
The Netherlands
Tel: 31-20-65-54-500
Fax: 31-20-65-37-871
*Tel: 31-20-65-54-555
*Fax: 31-20-65-37-873
New Zealand
Bausch&Lomb NZ Ltd.
2A Fisher Cresent
Mt. Wellington
Auckland, New Zealand
*Tel: 64-9-259-2762
*Fax: 64-9-259-4067
Philippines
c/o address in Singapore, see Singapore

Portugal
Bausch&Lomb S.A. (Sucursal Portugal)
Avenida do Forte N3
Edificio 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
*Fax: (65) 62860448
South Africa
Bausch&Lomb South Africa Pty. Ltd.
P.O. Box 5435, Rivonia
2128, South Africa
Street address:
Bausch&Lomb House
19 Autumn Street
Rivonia, Sandton
South Africa
Tel: 27-11-259-2600
*Tel: 27-82-820-5845
*Fax: 27-11-259-2650
Spain
Bausch&Lomb S.A.
Avda. Valdelaparra 4
28108 Alcobendas (Madrid) Spain
Tel: 34-91-657-6300
Fax: 34-91-661-4266
*Tel: 34-902-381-010
*Fax: 34-902-250-310

Sweden
(Denmark, Finland, Norway and Sweden)
Bausch&Lomb Nordic AB
Sder Mlarstrand, 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
Bausch&Lomb Taiwan Ltd.
11th Floor, No. 102, Section 4
Civill Boulevard
Taipei 10690
Taiwan, Republic of China
*Tel: 88-62-2776-0408
*Fax: 88-62-2776-6849
Thailand
Bausch&Lomb (Thailand) Limited
54 B.B. Building, 15th Floor, Room 1501
Sukhumvit 21 (Asoke) Road, Kwaeng Klong Toey Nua
Khet Wattana, Bangkok 10110
Thailand
*Tel: 66-2-259-6510
*Fax: 66-2-259-6511

Turkey
Bausch&Lomb Saglik ve Optik Urunleritic A.S.
Degirmen Yolu sok.
Sasmaz Plaza No: 4 Kat 12 Daire 24 Kozyatagi
Istanbul, Turkey
Tel: 90-216-373-3131 (switchboard)
Fax: 90-216-384-9489
*Tel: 33-4-37-488383
*Fax: 33-4-37-488384
United Kingdom
Bausch&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

8.2. Environmental Protection

Accessories such as disposable packs, handpieces, and tubing will be contaminated with human tissue
fragments and bodily fluids during the surgical process. These should be handled and disposed of in accordance
with current biomedical procedures.
The system and accessories and Foot Control may, in use, become contaminated with fluids from the operating
field and should be treated as biohazards and therefore need to be decontaminated.
When discarding any major component of the system, use local market techniques for disposal of standard
electronic components and equipment.

8.3. Warranty Information
Stellaris Vision Enhancement System Warranty

Bausch&Lomb Incorporated warrants, for the benefit of the purchaser only, that the Stellaris Vision
Enhancement System, when delivered, will conform to the manufacturers then current version of the published
specifications for the device in all material respects and shall be free from defects in material or workmanship
for a period of twelve (12) months from the date of delivery when properly installed, maintained and used for its
intended purpose and in accordance with all manufacturers instructions.
The exclusive remedy for any breach of this Warranty, and Bausch+Lombs only responsibility therefore,
shall be, at Bausch+Lombs option, the repair or replacement of the non-conforming defective equipment or
component thereof. Non-conforming or defective parts may be either repaired or replaced with new, refurbished,
or remanufactured parts at Bausch+Lombs sole discretion. Any such non-conforming or defective parts, which
are replaced by Bausch+Lomb, will become the property of Bausch+Lomb. Any service or replacement
part provided under this Warranty may be supplied by Bausch+Lomb or any of its affiliates or authorized
service providers, in Bausch+Lombs sole discretion. Any claim based on this Warranty must be submitted
to Bausch+Lomb, in writing, within the twelve (12) month warranty period which commences on the date of
delivery.
Bausch+Lomb reserves the right to deny warranty coverage, and shall have no responsibility to repair or
replace any non-conforming or defective equipment or component under this warranty if (a) the Stellaris
Vision Enhancement System is not maintained and operated in accordance with all manufacturers instructions,
(b) the non-conformity or defect arises from, or is related to, any service or maintenance of the equipment, or
component(s) thereof, provided by persons other than Bausch+Lomb or its authorized service representatives,
(c) the non-conformity or defect arises from, or is related to, any spare or replacement part(s) or component(s)
or any consumable or disposable products or parts which are used in the operation of the equipment or its
components other than those purchased from, installed by or approved for use by Bausch+Lomb or its
authorized service representatives, (d) the Stellaris 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+Lomb in
writing within the twelve (12) month warranty period. This Warranty does not apply to normal wear and tear or
disposable components used in connection with the Stellaris Vision Enhancement System.

BAUSCH+LOMB EXCLUDES AND DISCLAIMS ALL OTHER WARRANTIES OR

REPRESENTATIONS RELATING TO THE Stellaris Vision Enhancement System WHETHER
EXPRESS, IMPLIED OR ARISING BY OPERATION OF LAW, INCLUDING, BUT NOT LIMITED
TO, ANY WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
IN NO EVENT SHALL BAUSCH+LOMB BE LIABLE FOR, AND IT SPECIFICALLY DISCLAIMS
RESPONSIBILITY FOR, ANY INCIDENTAL, CONSEQUENTIAL, SPECIAL OR EXEMPLARY
DAMAGES OR EXPENSES ARISING OUT OF THE PURCHASE OR USE OF THE Stellaris
Vision Enhancement System, OR THIS WARRANTY, EVEN IF BAUSCH+LOMB HAS BEEN
ADVISED OF THE POSSIBILITY OF SUCH LOSS, DAMAGE OR EXPENSE. THE LIABILITY OF
BAUSCH+LOMB TO THE PURCHASER OR ANY USER FOR ANY CLAIM RELATED TO THE
Stellaris Vision Enhancement System OR THIS WARRANTY, WHETHER IN CONTRACT, TORT,
STRICT LIABILITY OR OTHERWISE, SHALL NOT EXCEED THE PURCHASE PRICE OF THE
Stellaris Vision Enhancement System PAID TO BAUSCH+LOMB.
Handpiece Warranty
Bausch+Lomb warrants ultrasonic handpieces against defects in materials and workmanship under normal
use for the minimum period of six (6) months from the date of delivery unless otherwise specified on your
sales tender or contract. If any such defect occurs within the warranty period, contact Bausch+Lomb to
return the handpiece for replacement. Bausch+Lomb will, as its sole obligation under this warranty, and
at its sole discretion, replace the defective handpiece with either a new or repaired/refurbished handpiece.
All replacement handpieces are covered for the balance of the warranty period remaining on the original
handpiece. Bausch+Lomb will arrange for replacement at no charge. Loss or damage in return shipment to
Bausch+Lomb shall be at purchasers risk.
The warranty shall not apply to, and Bausch+Lomb shall not be responsible for, any loss arising in
connection with the purchase or use of any handpiece which has been repaired or altered in any way so as, in
Bausch+Lombs judgment, to affect its reliability or which has been subject to misuse, negligence or accident,
or which has had the serial or lot number altered, defaced or removed, or which has been used otherwise then in
accordance with the instructions furnished by Bausch+Lomb. Bausch+Lomb neither assumes nor authorizes
any representative or other person to assume for it any other liability in connection with the sale of such
handpieces.
BAUSCH+LOMB DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING

ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE OR APPLICATION OTHER THAN THOSE EXPRESSLY SET FORTH IN THE
APPROPRIATE PRODUCT LABELING OR USER INFORMATION MANUAL. IN NO EVENT
WILL BAUSCH+LOMB BE LIABLE FOR ANY INCIDENTAL, INDIRECT OR CONSEQUENTIAL
DAMAGES IN CONNECTION WITH THE PURCHASE OR USE OF ITS PRODUCTS.
Post-Warranty Information:
When warranty coverage expires, Bausch+Lomb is pleased to provide special trade-in programs which offer
reduced cost replacements with additional warranty coverage. Contact your Bausch+Lomb sales representative
for additional details on current programs.

Caution:
Bausch+Lomb is the only authorized service organization for Bausch+Lomb ultrasonic handpieces.
Bausch+Lomb does not recommend having your ultrasonic handpiece repaired by third-party service
organizations and assumes no responsibility or liability for the function, safety or operation of any handpiece
repaired or serviced by anyone other than the Bausch+Lomb service organization.
Return Policy:
Bausch+Lomb will, within the return period as specified on your invoice, from the date of invoice, accept
return of this product for a full refund less any handling and shipping charges incurred by Bausch+Lomb.
Customer must call their local Bausch+Lomb customer service representative to request a Return Good
Authorization prior to expiration of the return period. It is the Customers responsibility to properly pack all
items being returned. A restocking charge of 15% of the purchase price listed on the invoice for the product, in
addition to any refurbishment, handling and shipping charges, may be assessed for any return received after the
return period but not greater than 180days of the invoice date.
Handpiece Disclaimer
Bausch+Lomb is the only authorized service organization for Bausch+Lomb handpiece. Bausch+Lomb
does not recommend having your handpiece repaired by third-party service organizations and assumes no
responsibility or liability for the function, safety of operation of any handpiece repaired or serviced by anyone
other than the Bausch+Lomb service organization.


9 Specifications
Specifications
9.1. Environmental and Physical Specifications
Note: This device contains items which may be classified as waste electrical or electronic equipment.
Please dispose of the equipment according to local requirements.

9 Specifications
Environmental Specifications
Parameter Specifications
Electrical Input Detachable international power cord
Universal Input (100-240 VAC, 50/60 Hz, 1000VA)
Equipotential grounding stud
Fuse Set BL4352includes (2)T 10AL, 250V slow-blow
(5mm x 20mm) fuses
Temperature Ambient Operating Temperature:
10 to 40 Celsius (50 to 104 Fahrenheit)
Ambient Storage/Transport Temperature:
-20 to 60 Celsius (-4 to 140 Fahrenheit)
Humidity Operating Humidity:
30% to 70% Relative
Storage/Transport Humidity:
10% to 98% Non-Condensing
Altitude Operates as rated up to 3,000feet above sea level
Shock/Vibration Passes ISTA 3A and 3H
MMC (Optional Accessory) Specifications
Electrical Input Detachable international power cord
Universal Input (100-240 VAC, 50/60 Hz)
75 VA rating
Fuse: Type GDC T1.0 A, 250V
Composite Video Cable RCA, male/male, 6feet
S-Video Cable S-Video, male/male, 6feet
FireWire Cable IEEE-1394 6P/4P 30 ANG, 6feet
Ethernet Cable RJ-45, 350 MHz, 50feet
Physical Specifications
Stellaris Vision 122cm (H) x 45.7cm (W) x 45.7cm (D)
Enhancement System 48in. (H) x 18in. (W) x 18in. (D)
(excluding IV Pole and 162.5cm (64in.) from floor to top of IV Pole
handle) Approximate Weight: 230pounds (114kg)
Recommended tray capacity: 12pounds (5.4kg)

9 Specifications
Standards Compliance
The Stellaris Vision Enhancement System is designed to meet the requirements of IEC 60601-1:2005 3rd
edition and all appropriate amendments, collateral standards, particular standards and country differences.
Equipment Classifications
Type of Protection Against Electrical Shock Class I
Degree of Protection Against Electrical Shock Type BF
Degree of Protection Against Water Ingress Ordinary
Mode of Operation Continuous
Electromagnetic Compatibility (EMC) Class A
The Stellaris Vision Enhancement System is a piece of medical equipment. As such, it requires special
precautions regarding electromagnetic compatibility (EMC). It should be installed and put into service
according to the EMC information provided in the tables below.
Portable and mobile RF communications equipment can potentially affect all electronic medical equipment,
including the Stellaris Vision Enhancement System. Guidance on maintaining appropriate separation between
communications equipment and the Stellaris Vision Enhancement System is provided in the tables below.
A complete line of accessories for the Stellaris Vision Enhancement System and other surgical instruments is
available from Bausch&Lomb. Contact your Bausch&Lomb sales representative or login to Storzeye.com and
visit the online store for detailed information. The use of accessories and cables other than those specified by
Bausch&Lomb in the table below may result in increased electromagnetic emissions or decreased immunity to
external electromagnetic radiation resulting in decreased patient safety.
As with all medical electronic equipment, the Stellaris Vision Enhancement System should not be used
adjacent to other equipment. If adjacent use is necessary, the Stellaris Vision Enhancement System should be
observed to verify normal operation in the configuration in which it will be used.
Note: The Stellaris Vision Enhancement System includes functions that use high frequency signals
for treatment, including bipolar coagulation and pulsed phaco. As with all systems using high
frequency signals, interference may occur between the bipolar function or the pulsed phaco
function and other equipment. If any physiological patient sensors are to be used in conjunction
with the Stellaris Vision Enhancement System, the phaco and bipolar circuits should be
activated briefly prior to contact with the patient while the sensor operator is monitoring the
output of the sensor. If there is noise observed on the sensor during the precheck or during
surgery, the operator may adjust the sensor according to the instructions of the sensor
manufacturer.
When phaco or bipolar functions and physiological monitoring equipment are used
simultaneously on the same patient, any monitoring electrodes should be placed as far as
possible from the surgical electrodes. Needle monitoring electrodes are not recommended.
In all cases, monitoring systems incorporating high-frequency current limiting devices are

9 Specifications
recommended. Properly-equipped monitors are usually identified as having electrosurgery

interference suppression or ESIS options.
Table of Cables
Cable Length
BL3170 Phaco Handpiece 84
BL4351US, Power Cable United States 180
BL4351UK, Power Cable Great Britain 180
BL4351EUR, Power Cable General Europe 180
BL4351ITL, Power Cable Italy 180
BL4351SWI, Power Cable Switzerland 180
BL4351CHI, Power Cable China 98
BL4394 Foot Control Backup Cable 144
Guidance and Manufacturers declaration electromagnetic emissions

The Stellaris Vision Enhancement System is intended for use in the electromagnetic environment
specified below. The customer or the user should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment guidance
The Stellaris Vision Enhancement System must emit
RF emissions
Group 2 electromagnetic energy in order to perform its intended
CISPR 11
function. Nearby electronic equipment may be affected
RF emissions
Class A
CISPR 11
Harmonic The Stellaris Vision Enhancement System is suitable for
Emissions Class A use in all establishments other than domestic establishments
IEC61000-3-2 and those directly connected to the public low-voltage power
Voltage supply network that supplies buildings used for domestic
fluctuations / purposes
Complies
flicker emissions
IEC 611000-3-3

9 Specifications
Guidance and Manufacturers declaration electromagnetic immunity

The Stellaris Vision Enhancement System is intended for use in the electromagnetic environment specified
below. The customer or the user should assure that it is used in such an environment.
Emissions test IEC 60601 test level Compliance level Electromagnetic environment guidance
Floors should be wood, concrete or ceramic
Electrostatic +/- 6 kV contact +/- 6 kV contact
tile. If floors are covered with synthetic
discharge(ESD)
material, the relative humidity should be at
IEC 61000-4-2 +/- 8 kV air +/- 8 kV air
least 30%.
+/- 2 kV for power +/- 2 kV for power
Electrical fast
supply lines supply lines Mains power quality should be that of a typical
transient / burst
+/- 1kV for input / +/- 1kV for input / commercial or hospital environment.
IEC61000-4-4
output lines output lines
+/-1kVdifferential +/-1kV differential
Surge mode mode Mains power quality should be that of a typical
IEC 61000-4-5 +/-2 kV common +/-2 kV common commercial or hospital environment.
mode mode
Voltage 5% UT (95%dip in 5% UT (95% dip in Mains power quality should be that of a typical
dips, short UT) for 0,5 cycle UT) for 0,5 cycle commercial or hospital environment. If the
interruptions 40% UT(60% dip in 40% UT (60% dip in user of the Stellaris Vision Enhancement
and voltage UT) for 5 cycles UT) for 5 cycles System requires continued operation during
variations on 70% UT(30% dip in 70% UT (30% dip in power mains interruptions, it is recommended
power supply UT) for 25 cycles UT) for 25 cycles that the Stellaris Vision Enhancement
input lines <5% UT(>95% dip <5% UT (>95%dip System be powered from an uninterruptible
IEC 61000-411 in UT) for 5 sec in UT) for 5 sec power supply or battery.
Note: UT is the a.c. mains voltage prior to the application of the test level.
Power
frequency Power frequency magnetic fields should be at
(50/60 hz) 3 A/m 3 A/m levels characteristic of a typical location in a
Magnetic field typical commercial or hospital environment
IEC 61000-4-8
Immunity Test IEC 60601 test level Compliance level Electromagnetic environment guidance

9 Specifications
Guidance and Manufacturers declaration electromagnetic immunity

Conducted RF 3 Vrms Portable and mobile RF communications
3 Vrms
IEC 61000-4-6 150 kHz to80 MHz equipment should be used no closer to any part
of the Stellaris Vision Enhancement System,
including cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of the
transmitter.
Recommended Separation distance
d = 1,2P (Conducted)
d = 1,2P 80 Mhz to 800 MHz (Radiated)
d = 2,3P 800 Mhz to 2,5 GHz (Radiated)
Where P is the maximum output power rating

Radiated RF 3 V/m of the transmitter in watts (W) according
3 V/m
IEC 61000-4-3 80 MHzto2,5 GHz to the transmitter manufacturer and d is the
recommended separation distance in metres
(m).
Field strengths from fixed RF transmitters, as

determined by an electromagnetic site surveya,
should be less than the compliance level in
each frequency range.b
Interference may occur in the vicinity of

equipment marked with the following symbol:
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular / cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, and
electromagnetic site survey should be considered. If the measured field 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.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m

9 Specifications
Recommended separation distances between portable and mobile RF

communications equipment and the Stellaris Vision Enhancement System
The Stellaris Vision Enhancement System is intended for use in an electromagnetic environment
in which radiated RF disturbances are controlled. The customer or the user can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the Stellaris Vision Enhancement System as
recommended below, according to the maximum output power of the communications equipment.
Rated maximum Separation distance according to frequency of transmitter metres (m)
output power of 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
transmitter (W) d = 1,2P d = 1,2P d = 1,2P
0,01 0,12 0,12 0,23
0,1 0,38 0,38 0,73
1 1,2 1,2 2,3
10 3,8 3,8 7,3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in metres (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

9 Specifications
9.2. Primary System Specifications
Computer Unit Specifications
Parameter Specification
Technology: Flat Panel, Liquid crystal display (TFT LCD)
full color
Size: 19 diagonal
Pixels: 1280 x 1024
Display
Physical Adjustment:
Tilt: +15 up and -10 down
Display Assembly Swivel: 90 left and 90 right
Brightness: Controlled via touch screen
Technology: Resistive Analog
Size: Approximately 19 diagonal active area
Touch Screen Environmental:
Chemical resistant to cleaning solutions
Drip proof bezel
Motherboard Technology: IBM Compatible, Pentium or better
Computer hardware Hard Drive or Solid State Drive
Computer Assembly Two Audio Speakers
Two USB ports
Ethernet port

9 Specifications
Foot Control Specifications
External components and housing are corrosion resistant
Watertight housing
Wireless control (10m standard range)
Corded, low voltage connection to system
General Non-skid base
4 gray colored function switches
Wall Charger
3.6v battery (lithium)
Battery charging cradle
12.22cm, 4.8125in.(H)
27.6cm, 10.875in. (W)
Physical
32.4cm, 12.75in. (L)
Weight 2.7kg, 6lbs.
Center pedal: Pitch Linear on/off
Left On/Off (simulated)
Right On/Off (simulated)
Center pedal: Yaw
Left Linear
Right Linear
Increase/decrease
Function switches On/Off
Function
Motion: Pitch (up/down)
Automatic return to up position
Center pedal: Pitch Detent: (2) programmable as to position, may be enabled or
disabled
Control: Provides primary linear function or on/off
Motion: Yaw (Left/Right)
Automatic return to center
Detent: (1) center detent,
Center Pedal: Yaw
Non-programmable control: Provides secondary linear function
in primary yaw direction and on/off control in secondary yaw
direction, may be physically set for greater linear movement
Motion: Momentary Push-button
Function switches Control: Provides programmable increment/decrement or on/off
control of assigned function

9 Specifications
Remote Control Unit Specifications
General Wireless pointing device providing line of sight operation
using an IR transmitter
Provides operation up to 15feet from display console
Powered from standard AA battery (batteries)
Low battery indicator
Transmit indicator
Splash-proof
Illuminated keys
Vacuum Level Increase/Decrease
Aspiration(ASP)
Flow Rate Increase/Decrease
Up
IV Pole
Down
Next Phase
Phase
Previous Phase
Increment
Ultrasound Power (U/S),
Decrement
Vitrectomy, Coagulation
(shared button)
Tab Future Use
Enter Future Use
Parameter increment/
Future Use
decrement

9 Specifications
IV Pole Specification
Automated
General
Provides two (2) bottle hooks
Capable of lifting two 500ml glass bottles of
Capacity
Balanced Salt Solution
Range of 110cm (43.3in.)
Travel (30cm. to 140cm., 13.8in. to 55in. from
Operation aspiration port)
Parameters Speed 10.6cm/sec. (4in./sec.)
Controlled via touch screen entry, remote control,
Control Foot Control, or directly via buttons on the back of
the system
Positioning Relative from home sensed position

9 Specifications
Coagulation Function Specifications
Single, Floating BF Connection
Connector
Coaxial connector
Coagulation
Connections United StatesBanana Jack Cord, Banana Jack to Coaxial
Cords adapter
InternationalReusable Coaxial Cord
Modes of Operation Linear Mode, Fixed Mode
Output Range: 7.5 Watts Nominal @ 100ohms
Frequency: 1 MHz nominal
Linear Mode Maximum Peak Open Circuit Voltage = 120V
Range: Programmable from 0% to 100% in 1% increments
Operating Control: Linear control of coagulation power via the footpedal
Parameters Output Range: 7.5 Watts Nominal @ 100ohms
Frequency: 1 MHz nominal
Fixed Control Maximum Peak Open Circuit Voltage = 120V
Range: Programmable from 0% to 100% in 1% increments
Control: On/Off control via the footpedal
Settings 8
100%
7 Power out Load
Settings
75% Load
6
50%
5
25% 4 Bipolar Power vs. Load
3
2
Power (watts)
1
0
100 200 300 400 500 600 700 800 900 1000
Load (ohms)
Maximum Possible Peak Coagulation Output Voltage at all Output Control Settings and Both Modes
Linear and Fixed Control
Peak Output (V)
Output Control Setting (%)

9 Specifications
Ultrasound Function Specifications
Ultrasound Time: System records and displays ultrasound time in
0.01second increments
Tuning: System provides one step tuning. Self adjusts to resonant
Special Features
frequency of handpiece
Probe Present: System provides a probe present detection system
Wave form ultrasound available
Connection Type: Floating BF Connection
Programming Levels 1,2,3:
Continuous ultrasound
Pulsed ultrasound
Fixed pulse ultrasound
Single burst ultrasound
Multiple burst ultrasound
Modes of Operation
Programming Level3 only:
Dual Linear Ultrasound
Linear Power, Linear Pulse ultrasound
Linear Power, Linear Duty Cycle ultrasound
Dual Linear Multiple Burst ultrasound
Variable Power Multiple Burst ultrasound
Variable Power Linear Burst ultrasound

9 Specifications
Ultrasound Function Specifications
Operating Specification
Parameter
Maximum Power: 35 Watts @ approx. 900ohms
Frequency: 28.5kHz nominal
Range: 0% to 100% power in 1% increments
Continuous Ultrasound Wave for Ultrasound: Disabled/Enabled (throughout)
Mode Control: Linear power control via the footpedal
Nominal phaco handpiece tip stroke at 100% power setting with
DP8130 Microflow needle is 130 m at 28.5 kHz. This results in
a nominal peak tip velocity of 11.6 m/sec.
Frequency: 28.5 kHz nominal
Pulsed Ultrasound Mode Range: 1 to 250pulses per second
Duty Cycle: 5 to 95% in 1% increments
Rise Time: 1 or 2
Single Burst Ultrasound Frequency: 28.5 kHz nominal
Mode Range: 80 to 600msec. burst width
Control: Single burst at end of pitch or yaw travel
Fixed Pulse Ultrasound Duration: 2 to 600msec
Mode Interval: 2 to 600msec
Control: Linear power control via the footpedal. Burst duration
and interval as selected
Range: 2 to 600msec. burst width
Multiple Burst Duty Cycle: 50 to 99% in 1% increments
Ultrasound Mode Rise Time: 1 or 2
Control: 1 burst at minimum duty cycle at start of linear
control region. Interval decreases until maximum duty cycle is
commanded at end of linear control region

9 Specifications
Vacuum Fluidics Function Specifications
Provides Cassette Full, Near-Full and Continuous Fluid
General Level Sensing
Programmable Rise time curves
Linear control of vacuum
Modes of
Fixed, On/Off control of vacuum
Aspiration Operation
Dual Linear Modes: Pitch or Yaw
I/A mode: 0mmHg to 600mmHg
Operating Phaco: 10mmHg to 600mmHg
Parameters Vitrectomy: 0mmHg to 600mmHg
Vacuum Control: 1mmHg increments
Gravity feed from I/V bottle with pinch valve On/Off control
Irrigation
via footpedal
Gravity feed or Pressurized Infusion from the Balanced Salt
Solution bottle
Reflux Control
Modes: Continuous
Activated via the Foot Control
Linear Cut
Range: 30 to 800cuts per minute in 1cut per minute
Rate Mode
increments
Operating
Control: Linear control of cut rate via the footpedal
Parameters
Vitrectomy
Fixed Cut
Rate Mode
increments
Operating
Control: On/Off control of cut via the footpedal
Parameters
The compressor module will provide a minimum of 600mmHg up to 3,000feet above sea level.
A derating of 19.4mmHG per 1000 ft. will be used for operation above 3,000 ft.

9 Specifications
Advanced Flow Function Specifications
General Programmable vacuum response
Flow Mode
Fixed flow fixed vacuum limit
Fixed flow linear vacuum limit
Modes of Linear flow fixed vacuum limit
Operation Linear Flow Linear Vacuum Limit
Vacuum Mode
Fixed vacuum
Linear vacuum
Flow
Aspiration I/A Mode: 0ml/min to 60ml/min
U/S Mode: 5ml/min to 60ml/min
Flow Mode Vit Mode: 0ml/min to 60ml/min
Operating Vacuum Limit
Parameters I/A mode: 0mmHg to 650mmHg
U/S: 10mmHg to 650mmHg
Vitrectomy: 0mmHg to 650mmHg
Vacuum Control: 1mmHg increments
Vacuum Mode I/A: 0 - 600mmHg
Operating U/S: 10 - 600mmHg
Parameters Vit: 0 - 600mmHg
Gravity feed from I/V bottle with On/Off control provided in
Irrigation
cassette
Control Activated via Foot Control
Safety Reflux volume depend on operation mode only
Reflux Modes Single, repeat or continuous
Note: Active reflux volumes will be software controlled via reversal of
Advanced Flow Pump
Linear Cut
Rate Mode
increments
Operating
Control: Linear control of cut rate via the footpedal
Parameters
Vitrectomy
Fixed Cut
Rate Mode
increments
Operating
Control: On/Off control of cut via the footpedal
Parameters

9 Specifications
Pressurized Infusion Specifications
Input Atmospheric air with 0.1 micron hydrophobic filter
Pressurized 100mmHg maximum air pressure, flow rates up to
Infusion 6.5standard cubic feet per hour
Pressure
Range: 1-100mmHg
Control: 1mmHg increment

9 Specifications
System Labels
Main System Label Foot Control Label
Large Remote Control Label
Small Remote Control Label System Power and Fuse Label
Foot Control Battery Label Foot Control Battery Compartment Label

9 Specifications

Index
Index
A
Accessories 7-21
Actual Phaco Time (APT) 4-20
Advanced Flow Fluidics 4-12
Agency Certifications 9-3
APT (Actual Phaco Time) 4-20
Aspiration
Handpiece
Cleaning 5-5
Sterilization 5-7
Operation 4-7
Aspiration Setup, Vacuum Fluidics 4-14
Aspiration, Ultrasound 4-24
Assistance 8-2
Audio Tab 2-11
AVE (Average Ultrasound Power) 4-20
Average Ultrasound Power (AVE) 4-20
A/V More Screen 2-11
B
Backup 3-15
Batteries, Remote Control 4-6
Burst (U/S) 4-20, 4-23
Button, Spin 2-1
C
Calibration
U/S 4-24
Capsule Polish
Operation 4-8, 4-12
Cassette Full 4-7
Cassette Nearing Full 4-7
Cleaning
Handpiece
Bipolar Accessories 5-3
For U.K. 5-14
Irrigation/Aspiration 5-5
Phacoemulsification 5-8
Needle
Ultrasound 5-11
Transducer 5-4
Clock Menu 2-14
110017243EN Rev. H
Index
Coag Display 2-16

Coag Spin Control 2-16
Coagulation
Accessories
Cleaning 5-3
Setup
Fixed 4-28
Linear 4-29
Function
Description 1-15
Specifications 9-12
Coagulation More 2-9
Computer Unit
Operation 4-1
Specifications 9-8
Connections
Electrical 6-2
Customize Exception 3-8
D
Date, Format 3-18
Date, Setting 3-18
DC (Duty Cycle) 2-8, 2-16, 4-20
Delete Settings File 3-17
Description
Function 1-15
IV Pole 4-5
System 1-2, 1-12
Display, Level 1 2-14
Display, Level 2 2-17
Disposables
Setup and Use
Coagulation
Fixed 4-28
Linear 4-29
Dual Linear Control 2-29
Duty Cycle 2-8, 2-16, 4-20
110017243EN Rev. H
Index
E
Effective Phaco Time (EPT) 4-20
Enterprise Server 1-10
Environmental Protection 8-12
Equipment Classifications 9-3
Error Messages 7-3
Ethernet Cable 1-4
Exception, Customizing 3-8
Exceptions 2-14
F
Flow Status 2-16
Fluidics More Settings 2-7
Fluidics, Vacuum 4-7
Foot Control 6-3
Battery Charging 2-27
Description 1-15, 2-18
Functions 2-29
Linear Control 2-33
Operation
Aspiration 4-9
Irrigation 4-9
Ultrasound 4-20
Vitrectomy 4-19
Specifications 9-9
Footpedal 2-30
Footpedal More 2-10, 2-30
Footpedal Status 2-16
Fuse
Replacement 7-1
H
Handpiece
Cleaning
For U.K. 5-14
Sterilization
For U.K. 5-14
Height, IV Pole 2-7
High-Speed Electric Vitrectomy Cutter 4-14
110017243EN Rev. H
Index
I
I/A
Handpiece
Cleaning 5-5
Sterilization 5-7
Irrigation
Handpiece
Cleaning 5-5
Sterilization 5-7
Operation 4-7
IV Pole 2-15
Description 4-5
Specifications 9-11
IV Pole Height 2-15, 3-28
K
Keyboard 2-4
L
Language 2-12, 3-5, 3-13, 3-18
Layout, Screen 2-14
Level 1 Display 2-14
Level 2 Display 2-17
M
Maximum IV Pole Height 3-28, 4-5
Menu, Clock 2-14
MMC (MultiMedia Center) 1-17
Module
Coagulation,. See AlsoCoagulation Module
Computer Unit,. See AlsoComputer Unit
IV Pole,. See AlsoIV Pole
Ultrasound,. See AlsoUltrasound Module
More, Coagulation 2-9
More, Footpedal 2-10
More Screen, A/V 2-11
More Screens 2-6
More Settings, Fluidics 2-7
More Settings, Ultrasound 2-8
More, Vitrectomy 2-9
MultiMedia Center 1-17
Multimedia Center (MMC), setup 6-3
110017243EN Rev. H
Index
N
Needle
Cleaning 5-11
Sterilization 5-12
O
Operation
Aspiration 4-7
Capsule Polish 4-8, 4-12
Computer Unit 4-1
Control
Numeric Keypad 2-3
Pop-Up Window 2-5
Progress Bar 2-3
Test Tube Control 2-2
Foot Control. See AlsoFoot Control Operation
Irrigation 4-7
Phacoemulsification
Burst 4-20
Linear 4-22
Pulse 4-20
Turning on System 1-4
Viscoelastic Removal 4-8, 4-13
Vitrectomy
Cutter Modes 4-16
General 4-14
Yaw Aspiration 4-23
Option List 2-2
P
PD (Pulse Duration) 4-20
Phaco (Phacoemulsification cation) 4-20
PI (Pulse Interval) 4-20
Pneumatic Vitrectomy Cutter 4-15
PPS (Pulses Per Second) 2-8, 2-16, 4-20
Pressurized Infusion 2-7, 2-15, 3-8, 3-28, 4-30, 4-32, 7-18
Pulse Duration (PD) 4-20
Pulse Interval (PI) 4-20
Pulse Mode Ultrasound 4-20
Pulses Per Second (PPS) 2-8, 2-16, 4-20
Push Bar 2-1
110017243EN Rev. H
Index
R
Reflux 2-29, 2-33, 4-8, 4-12, 4-13, 4-18, 4-19
Remote Control
Description 4-6
Specifications 9-10
Remote Control, Batteries 4-6
Remote Control Tab 2-13
Replacement
Fuse 7-1
Restore Preference File 3-16
Rise Time (U/S) 9-14, 9-15
S
Screen Display Tab 2-12
Screen Layout 2-14
Settings, Managing 3-3
Settings, More 2-8, 2-13
Setup
Coagulation
Fixed 4-28
Linear 4-29
Setup, MMC 6-3
Specifications
Advanced Flow 9-16
Cables 9-4
Coagulation 9-12
Computer Unit 9-8
EMI 9-4
Environmental 9-1, 9-2
Foot Control 9-9
High Speed Vitrectomy 9-15
I/A Vitrectomy 9-15
IV Pole 9-11
MMC 9-2
Physical 9-2
Remote Control 9-10
Ultrasound 9-13
Vacuum Fluidics 9-15
Spin Button 2-1
Sterilization
I/A Handpiece 5-7
Phacoemulsification Handpiece 5-12
Phacoemulsification Needle 5-12
Surgeon Preference File, Create 3-14
System Settings 2-6
110017243EN Rev. H
Index
T
Tabbed Screen 2-7
Technical Assistance 8-2
Test Tube Control 2-2
Time, Format 3-18
Time, Setting 3-18
Transducer
Cleaning 5-4
Troubleshooting 7-1
Trulink Remote Access 1-16
TruLink Remote Access 3-23
U
Ultrasound
Handpiece
Cleaning
For U.K. 5-14
Sterilization
Module
Specifications 9-14
Needle
Cleaning 5-11
Sterilization 5-12
Operation
Burst 4-20, 4-22
Linear 4-22
Pulse 4-20
Phacoemulsification
Module
Description 1-15
Specifications 9-13
Operation
Burst 4-20, 4-22
Linear 4-22
Pulse 4-20
Power 4-20
Ultrasound More Settings 2-8
Ultrasound (U/S). See AlsoU/S
Unpacking 6-2
Unplanned Vitrectomy Setup, Vacuum Fluidics 4-18
U/S (Ultrasound) 1-15
110017243EN Rev. H
Index
V
Vacuum Fluidics Function 4-7
Vacuum Fluidics, Unplanned Vitrectomy Setup 4-18
Vacuum Fluidics Vitrectomy 4-14
Vacuum Limit Settings 2-16
Vacuum Response 4-8, 4-13
Venting 4-8, 4-12
Video Overlay Tab 2-12
Operation 4-8, 4-13
Vitrectomy Cutter, High-Speed Electric 4-14
Vitrectomy Cutter, Pneumatic 4-15
Vitrectomy More 2-9
Voice Confirmation 2-11
W
Warranty Information 8-13
Y
Yaw
Aspiration 2-33
110017243EN Rev. H
Getting Started
User Interface
Detailed Reference
Cleaning / Sterilization
Setup
Troubleshooting / Maintenance
Specifications
Getting Started
User Interface
Detailed Reference
Cleaning / Sterilization
Setup
Troubleshooting / Maintenance
Specifications

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Operators Manual

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Indications for Use

All other brand/product names are trademarks of their respective owners.

110017243EN Rev. H Preface-1

Preface-2 110017243EN Rev. H

Symbols and Notes

DANGER: Calls attention to an operating procedure, practice, or condition, which if disregarded or

WARNING: Calls attention to an operating procedure, practice, or condition, which if disregarded or

CAUTION: Calls attention to an operating procedure, practice, or condition, which if disregarded or

Note: Calls attention to an operating procedure, practice, or condition providing essential

Consult operating instructions.

Caution or warning to consult accompanying documents to avoid patient or operator hazard.

110017243EN Rev. H Preface-3

Direct Current Alternating Current

Remote Control Reception Indicator

Dispose of Properly Battery Condition Indicator

Serial Number Manufacturer

Frequency in Hertz Type BF Applied Part

Ethernet Pneumatic Vitrectomy

Preface-4 110017243EN Rev. H

Member Green Dot Scheme

Do Not Use if Package is Damaged

System transport information, refer

110017243EN Rev. H Preface-5

Preface-6 110017243EN Rev. H

3. Customizing Your System

5. Cleaning and Sterilization Requirements

7. Troubleshooting and Maintenance

8. Service and Warranty

WARNING: Electromagnetic interaction between the phacoemulsification (phaco) handpiece and

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

WARNING: Avoid skin-to-skin contact.

110017243EN Rev. H Operator's Manual 1-1

1.1. System Description

User Interface Screen

Handpiece Connectors Expansion Space

One-Touch Wheel Locking

1-2 Operator's Manual 110017243EN Rev. H

1.2. Setting Up Your System

110017243EN Rev. H Operator's Manual 1-3

Surgical Drape Setup

Apply Screen Drape Here

Remote Control Drape

Turn on the switch at the bottom of the system console.

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

1-4 Operator's Manual 110017243EN Rev. H

Figure1.1. Lower Rear of System.

110017243EN Rev. H Operator's Manual 1-5

1-6 Operator's Manual 110017243EN Rev. H

Uninterruptible Operation of Your System

To Start a New Procedure

110017243EN Rev. H Operator's Manual 1-7

1. Setup Fluid Collection System

1-8 Operator's Manual 110017243EN Rev. H

110017243EN Rev. H Operator's Manual 1-9

Advance to Surgery Phase

Using Your System in Surgery

Your system is now ready for the surgical procedure.

Surgical Procedure Conclusion

1-10 Operator's Manual 110017243EN Rev. H

Remove the fluidics collection device.

110017243EN Rev. H Operator's Manual 1-11