Bausch&Lomb Stellaris User manual
Operator’s 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
One Bausch & Lomb Place
Rochester, NY 14609 USA
Bausch & Lomb Incorporated
106 London Road, Kingston upon Thames, KT2 6TN, UK
Manufacturing site:
Bausch & Lomb Incorporated
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 safety’s sake, please heed these precautions.
Patents
The Bausch+Lomb Stellaris® Vision Enhancement System is covered by the following patents: 5,331,951;
5,370,602; 5,388,569; 5,406,503; 5,624,394; 5,795,328; 5,910,139; 5,964,746; 5,991,142; 6,045,527; 6,055,458;
6,077,272; 6,081,122; 6,083,195; 6,106,512; 6,203,516; 6,251,113; 7,168,930, 7,445,436 and 7,604,607;
additional patents pending. Foreign and other patents may also apply.
Trademarks
®/™ are trademarks of Bausch & Lomb Incorporated or its affiliates.
All other brand/product names are trademarks of their respective owners.
Preface-1 110017243EN Rev. H
Preface
Power Outputs
COAG U/S
BF BF
7.5 W 35 W
100 Ω 900 Ω
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 don’t want
you to have to search to find it.
This manual is organized so that in the first chapter you will find enough information to quickly get up and
running, and get answers to general questions about the Stellaris® Vision Enhancement System . We have
included plenty of pictures so you can grasp concepts quickly. Be sure to read 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:
WARNING:
CAUTION:
Note:
Consult operating instructions.
Calls attention to an operating procedure, practice, or condition, which if disregarded or
incorrectly performed, could result in imminent explosion hazard and risk of death or serious
injury.
Calls attention to an operating procedure, practice, or condition, which if disregarded or
incorrectly performed, could result in serious and/or permanent injury to personnel and/or
patients.
Calls attention to an operating procedure, practice, or condition, which if disregarded or
incorrectly performed, could result in damage to the product and/or equipment.
Calls attention to an operating procedure, practice, or condition providing essential
information.
Caution or warning to consult accompanying documents to avoid patient or operator hazard.
Preface-3 110017243EN Rev. H
Preface
Direct Current
Equipotential
Ground
Remote Control Reception Indicator
(Foot Control On/ TruLink® Access)
Dispose of Properly
Serial Number
Authorized Representative
in the European Community
Non Ionizing
Electromagnetic
Radiation
Frequency in Hertz
Alternating Current
Foot Control
Battery
Battery Condition Indicator
Manufacturer
Date of Manufacture
Caution: Consult
Accompanying Documents
Type BF Applied Part
Fuse
Camera Recorder
Ethernet
Monitor
Stellaris®
Vision Enhancement System .
USB
or
or
or
Ω
VA
A
Coagulation
Pneumatic Vitrectomy
Ultrasound
Ohms
Volt Amps
Amperes
Preface-4 110017243EN Rev. H
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 .
Preface
Caution: Consult
Accompanying Documents
Preface-5 110017243EN Rev. H
Preface
Preface-6 110017243EN Rev. H
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 Con guration ........................................................................................................................... 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. Phacoemulsi cation 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 Con gurations, 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 Speci cations ............................................................................................ 9-1
9.2. Primary System Speci cations ............................................................................................................... 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:
WARNING:
WARNING:
WARNING:
WARNING:
Implantable defibrillators present a risk of injury if triggered by a fibrillatory event during
intraocular surgery, due to involuntary motion by the patient. Patients being considered for
intraocular procedures must be questioned to determine if they have such a device and, if so,
the defibrillator manufacturer must be consulted to determine the appropriate action.
Electromagnetic interaction between the phacoemulsification (phaco) handpiece and
an implanted cardiac pacemaker is unlikely, but cannot be ruled out. Patients should be
questioned to determine if they have such an implant and, if so, the manufacturer of the
implant should be consulted to determine the proper course of action.
Patient not to come in contact with earthing metal parts.
Avoid skin-to-skin contact.
Grounding reliability can only be achieved when the equipment is connected to an equivalent
receptacle marked “Hospital Only” or “Hospital Grade.”
WARNING:
To avoid risk of electric shock, this equipment must only be connected to a supply mains with
protective earth.
Operator's Manual 1-1 110017243EN Rev. H
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
Fluidic Module
Surgical Tray
Expansion Space
Drawer
One-Touch Wheel Locking
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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:
Note:
WARNING:
WARNING:
WARNING:
Before the first use of the Stellaris® Vision Enhancement System , connect the Foot Control as described on
page6-3 .
This system should only be operated by personnel who have been trained and are qualified to
use this system.
Do not add unapproved accessories that modify the effective IV pole height.
Do not manually force the IV Pole downward if the system is on.
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.
When using gravity infusion, the ophthalmic irrigation source shall be at or above the
patient’s eye level to avoid patient injury.
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.
Operator's Manual 1-3 110017243EN Rev. H
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:
CAUTION:
Do not turn this switch off until the system has been properly powered down.
Do not disconnect system from power while in use.
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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.
Operator's Manual 1-5 110017243EN Rev. H
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.
1-6 Operator's Manual 110017243EN Rev. H
1 Getting Started
Select Options
Touch the surgeon’s name on the list that appears, and it will be highlighted. Then select Confirm to load the
parameters for that surgeon and advance to the Setup Screen .
To setup a new surgeon instead of using an existing one, select Create New to setup a surgeon preference file
for a new surgeon, using parameters from an existing surgeon.
Setup Screen
The Setup Screen allows you to set certain procedure parameters, and prepare the system for surgical
procedures.
If desired, select Select Room and choose the case number, number of operating rooms being used by the
surgeon, and the particular operating room to be used.
If desired, select Select Case and choose the specific technique, needle, grade and pathology for the current
procedure.
Advance to open pack step by selecting Open Pack Insert Cassette from the clock menu.
Uninterruptible Operation of Your System
Some Stellaris models may have a 60-second memory back-up battery. This battery is not considered a
UPS (uninterruptible Power 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.
Operator's Manual 1-7 110017243EN Rev. H
1 Getting Started
Note:
1. Setup Fluid Collection System
Open disposables pack and connect fluid collection system.
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.
Ensure sufficient volume of irrigation solution is available for the procedure. The level should be
monitored during the procedure.
• 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 .
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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:
a. Spike the Balanced Salt Solution bottle and hang it at the desired bottle height.
b. Connect the irrigation and aspiration tubing to the appropriate (phaco or vitrectomy) handpiece,
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
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.
If a linear coagulation in setup is enabled or a Foot Control button is programmed for
coagulation, begin by plugging in the coagulation cord.
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.
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.
valve shall be opened when this step is displayed.
WARNING:
The animations illustrate the steps but do not represent sterile technique.
Operator's Manual 1-9 110017243EN Rev. H
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:
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.
Make sure to close the Irrigation Clamp on the Administration Tube Set before ending a
procedure or overflow may occur.
1-10 Operator's Manual 110017243EN Rev. H
Remove the fluidics collection device.
1 Getting Started
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 .
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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 unit’s 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 unit’s pole hanger and store
separately from the unit.
8. Make sure no objects such as air hose, electrical cord, video cables,
etc... lie in the moving path.
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.
9. Disengage the front brake lever.
10. Always maneuver the unit using the handle bar designed for this
purpose.
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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:
WARNING:
WARNING:
Use only handpieces, cables, and accessories designated by Bausch+Lomb for use with this
system.
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.
Manufacturers of implantable defibrillators recommend that these devices be temporarily
disabled when using bipolar cautery on patients with implants. The surgeon should determine
if the patient has such a device and consult the manufacturer for appropriate actions.
User Interface Screen
The User Interface Screen is the way the user communicates with the Vision Enhancement System . See page2-1
for details. Technical specifications can be found in Chapter9 .
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1 Getting Started
Stellaris® Vision Enhancement System Console
User Interface Screen
System Switch
“ON/OFF”
Handpiece Connectors
Surgical Tray
IV Pole
Pneumatic Anterior
Vit Acuator
Expansion Space
Fluidic Module
Drawer
One-Touch Wheel Locking
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.
1-14 Operator's Manual 110017243EN Rev. H
Air Pressure
Output Connector
1 Getting Started
USB Port Access
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 (Phacoemulsi cation)
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
Operator's Manual 1-15 110017243EN Rev. H
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.
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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.
Operator's Manual 1-17 110017243EN Rev. H
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.
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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.
Operator's Manual 2-1 110017243EN Rev. H
2 User Interface
Option List
The Option List allows you to select an option. A small + next to a setting indicates that additional choices are
available, and selecting the currently displayed option will bring up a list. Only one option can be selected at a
given time. Selecting one option automatically deselects others.
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.
Maximum Limit
Current Max Settings
Function Minimum
Actual Value
Slider Ring
2-2 Operator's Manual 110017243EN Rev. H
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