905-2120-005 G, Text
905-2120-005 G, Text
905-2120-005 G, Text
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REVISION HISTORY
REV ECN/CN # DATE
P0 --
A 20171060 07-NOV-2017
B CN076879ECN 05-MAR-2018
C CN077951ECN 05-MAY-2018
D CN083454ECN 20-FEB-2019
E CN098270ECN 09-DEC-2019
F CN099776ECN 24-MAR-2020
G CN103771ECN 05-MAR-2021
TEXT FOR
CONSTELLATION™
OPERATOR'S MANUAL (CR5)
NOTES:
1. Inspect per Generic QIP Manual. 1
2. Safety critical component.
SHEET 1 of 303
BY DATE
Troy Hinzman 10/12/2017 TITLE
®
CHECKED
TEXT,MNL,OPS,CONST_REL 5
Jeff Naemura 10/12/2017
OPERATOR'S MANUAL
Manufacturer:
Alcon Laboratories, Inc.
6201 South Freeway
EC REP
Fort Worth, Texas 76134-2099 USA Alcon Laboratories Belgium
Made in USA with Global Materials Lichterveld 3
2870 Puurs-Sint-Amands
Belgium
Produced By:
Alcon Research, LLC.
15800 Alton Parkway
Irvine, California 92618-3818
USA
Telephone: 949/753-1393
800/832-7827
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TABLE OF CONTENTS
SECTION ONE - GENERAL INFORMATION PAGE #
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.1
Intended Use(s). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.2
Indications for Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.2
System Configurations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.3
Constellation™ Vision System Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.4
Terms and Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.6
Labeling. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.7
System Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.10
Source Pressure Requirements (Air or N2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.10
Accessory Equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.10
Environmental Issues. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.10
User Information - Environmental Considerations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.11
Universal Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.12
Electromagnetic Compatibility (EMC) Compliance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.12
Guidance and Manufacturer's Declaration - Electromagnetic Emissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.12
Guidance and Manufacturer's Declaration - Electromagnetic Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.13
Equipment contains radio transmitters: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.14
USA – Federal Communications Commission (FCC) Compliance Statement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.14
FCC Radiation Exposure Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.14
Canada – Industry of Canada (IC) Compliance Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.15
Canada – Industry of Canada (IC). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.15
Europe – Radio Equipment Directive (RED) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.16
Summary of Constellation™ RFID Certifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.16
INTREPID™ AutoSert™ IOL Injector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.20
Diathermy, Cautery, Coagulation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.25
Product Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.27
Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.28
Illuminator Professional User's Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.29
Laser Professional User's Information: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.31
Laser Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.32
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SECTION FIVE - TROUBLESHOOTING PAGE #
System Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.1
System Fault Messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.2
System Error Messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.3
System Advisory Messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.4
System Information Messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.5
Power Lost/Recovery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.6
Recovery from an Unrecoverable Fault Screen or Unexpected Shut Down . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.7
Event Log. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.10
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FOREWORD
This Operator’s Manual is designed to acquaint the operator and operating room personnel with
the Constellation™ Vision System. The manual presents an organized summary of the operating
principles, main components, safety features, and instructions for care and use of the instrument.
The information in this manual should be supplemented with reference works on laser theory and the
interaction of laser energy with biologic tissues. No attempt is made in this manual to answer all the
questions that arise during the use of the instrument in medical procedures.
Questions concerning technique, safety and effectiveness should be referred to pertinent publications
or recognized medical experts in laser surgery. Physicians should not attempt to treat patients with
this instrument if not thoroughly familiar with its operation, or if in doubt as to its safe operation. All
personnel authorized to use this instrument should be required to be thoroughly familiar with this
manual.
Please contact Alcon for complete technical support and service if you have questions concerning any
aspect of this instrument’s operation or if it fails to perform satisfactorily.
Equipment improvement is an on-going process and, as such, changes may be made to the equipment
after this manual is printed.
Pay close attention to WARNINGS and CAUTIONS in this manual. WARNINGS are written to
protect individuals from bodily harm. CAUTIONS are written to protect the instrument from damage.
Illustrations contained in this manual are for reference only.
Alcon Surgical shall not be liable for any damage resulting from failure to comply with the enclosed
instructions.
Operator Profile
The Constellation™ Vision System is designed to be operated by two basic groups; surgeons and
nurses/scrub techs. The surgeon focus is primarily constrained to the footswitch and display panel.
The design of the footswitch allows the surgeon to map any function to any switch position, assuming
the function is valid in a particular scenario. The display screen was designed to mount on an
articulating arm to allow optimum placement of the display so the surgeon can reference it at any
time. The design also incorporates items specifically for nurses and scrub technicians, who routinely
control the machine via the front panel and remote control. The design incorporates color coding on
all connectors and tubing to facilitate easy identification of the ports. In addition, the graphical user
interface closely resembles controls commonly found on web sites, which this operator profile is
expected to be highly proficient at using.
CAUTION
U.S. Federal Law restricts this device to sale by or on the order of a physician only.
WARNINGS!
For systems containing the optional laser module: Use of controls or adjustments, or
performance of procedures other than those specified herein may result in hazardous
laser radiation exposure.
A qualified technician must check ground continuity and both polarities for leakage
current every twelve months to ensure they are within the applicable standard (for
example: IEC 60601-1). Values must be recorded, and if they are above the applicable
standard, or 50% above your first measurement, do not use the system; call Alcon
Technical Services.
Use of accessories and cables other than those provided may result in increased
emissions or decreased immunity of the system. Portable and mobile RF
communications equipment can affect this medical electrical equipment.
If you have questions, or want additional information, please contact your local Alcon representative
or the Alcon Technical Services Department at:
All rights reserved. No part of this manual may be reproduced, transmitted, or stored in a retrieval
system, in any form or by any means; photocopying, electronic, mechanical, recording, or otherwise;
without prior written permission from Alcon Laboratories, Inc.
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Illuminator
Table Top
Auxillary Illuminator
Laser Module
Footswitch
(storage position)
SYSTEM CONFIGURATIONS
The Constellation™ Vision System is designed with a modular approach that allows
the system to be highly configurable to meet the needs of many users. The system is
designed around the Table Top where the accessories listed below can be added for
expanded functionality.
• Table Top
• Base
• Laser Module
• Auxiliary Illuminator
• Tray Arm Assembly (includes ballast and support column)
• High Definition Video Overlay (HDVO)
The Table Top can operate as a standalone unit (Configuration 1), and is also the
primary user interface that operates and controls the add-on accessories. The table
below shows the nine possible configurations for the Constellation™ Vision System.
Part numbers and ordering information is located in Section Six of this manual.
Table 1-1 SYSTEM CONFIGURATIONS1
Table Tray Arm Laser Auxiliary
Configuration Base HDVO
Top Assy Module Illuminator
1 x Optional
2 x x Optional
3 x x x Optional
4 x x x x Optional
5 x x x x Optional
6 x x x x x Optional
7 x x x Optional
8 x x x Optional
9 x x x x Optional
1 All Illuminators are equivalent in function and may contain either a lamp or light channels. Xenon-based
Illumination module refers to a lamp and phosphor-based illumination module refers to a light channel.
DIATHERMY ACCESSORIES (Rated Voltage): Fill Purity: See gas concentration chart in Section Two.
ILLUMINATION: PHACOEMULSIFICATION:
Footswitch Labels:
- Footswitch Product Label
- Footswitch UDI Label
Front of System
Source Pressure
Label
Rear of System
European
Conformity Marking 1
Fragmentation Laser Port 1
Surgical Step OSHA
recognizedNRTL,
TÜV SÜD America
mark, providing Tethered Laser
electrical safety
Irrigation/Aspiration certification to
Surgical Step North American Magnetic
MR
requirements for Resonance Unsafe
medical devices.
Coagulation Manufacturer
Laser
Surgical Step Connector
Connection Multi-Function Port
Indicator
Phaco
Surgical Step Network
Dangerous Voltage Connection
Caution: Consult
!
Power Scissors Connector
accompanying
documents
General Warning
(black symbol with Serial In/Out
Save yellow background)
Standby State
Illuminator
AC AC In
SYSTEM
AC Out System Fault
AC FAULT
Intelligent Phaco
Aiming Beam System Information
U/S Handpiece
Connector Viscous Fluid Video Out
Control Connector
USB Connector
SYSTEM INSTALLATION
In the USA contact the Alcon Technical Services Department for uncrating and
installation at (800) 832-7827. Outside the USA contact your local Alcon affiliate.
WARNING!
Verify tank pressure/facility pressure prior to surgery. If air source replacement
is needed during surgery, be sure to remove instruments from the eye and plug
cannulas as necessary. The system will revert to a backup BSS™ pressure of
30 mmHg.
ACCESSORY EQUIPMENT
Accessory equipment connected to or used with this equipment must be certified
according to the respective IEC Standard (e.g., IEC 60601-1 for medical equipment).
The Constellation™ Vision System is shipped with English and metric fittings
compliant with EN ISO 5359. Anyone connecting additional equipment or otherwise
causing a different system configuration than provided by Alcon is responsible for
continued compliance to the requirements of System Standard IEC 60601-1-1 and
EN ISO 5359. If in doubt, consult the Technical Services department or your local
Alcon representative.
WARNING!
Any non-medical equipment (i.e., VCR, monitor, MP3 player, etc.) must be placed
outside the patient environment (at least 1.5 meters away from patient).
ENVIRONMENTAL ISSUES
Follow local governing ordinances and recycling plans regarding disposal or
recycling of device components.
In order to avoid the entry of any such substances into our environment, and to
promote natural resource conservation, please install, maintain, and operate the
equipment in accordance with the instructions. Information on the location of
hazardous substances, resource consumption and emissions of the equipment can
be found throughout this Operator's Manual. Please use the appropriate take-back
systems. Such take-back systems reuse or recycle many of the materials in your
end-of-life equipment in a beneficial way. Please contact your local Alcon office for
assistance in take-back options through Alcon or other providers.
The crossed-bin symbol located on this equipment reminds you to use take-back
systems, while also emphasizing the requirement to collect waste equipment
separately, and not dispose of it as unsorted municipal waste. The Pb notation, if
Pb present, indicates that the labeled device contains greater than 0.004% lead.
If you need more information on the collection, reuse or recycle systems available to
you, please contact your local or regional waste administration, or contact your local
Alcon office for more information.
Universal precautions shall be observed by all people who come in contact with the
instrument and/or accessories to help prevent their exposure to blood-borne pathogens
and/or other potentially infectious materials. In any circumstance, wherein the exact
status of blood or body fluids/tissues encountered are unknown, it shall be uniformly
considered potentially infectious and handled in accordance with OSHA guidelines.
It is important to install and use the equipment in accordance with the instructions
in order to prevent harmful interference with other devices in the vicinity. If this
equipment causes harmful interference to other devices (determined by turning the
equipment off and on), the user is encouraged to try to correct the interference by one
or more of the following measures:
WARNINGS!
Use of the Constellation™ Vision System adjacent to or stacked with other equipment
should be avoided because it could result in improper operation. If such use is
necessary, this equipment and the other equipment should be observed to verify that
they are operating normally.
Use of accessories, transducers and cables other than those specified or provided
by the manufacturer of the Constellation™ Vision System could result in increased
electromagnetic emissions or decreased electromagnetic immunity of Constellation™
Vision System and result in improper operation.
Radiated RF 3 V/m 3 V/m The dwell time should be at least 1 s and should
IEC 61000-4-3 80 MHz to 2.7 GHz 80 MHz to 2.7 GHz be no less than the response time of the slowest
responding function plus the settling time of the
IMMUNITY test system.
Proximity Fields Frequency Level Frequency Level The IMMUNITY TEST LEVELS specified in
IEC 61000-4-3 (MHz) (V/m) (MHz) (V/m) the table were calculated using the following
385 27 385 27 equation:
E=(6√P)/d
450 28 450 28
Where P is the maximum power in W, d is the
710, 745, 780 9 710, 745, 780 9
minimum separation distance in m, and E is the
810, 870, 930 28 810, 870, 930 28 Immunity Test Level in V/m. The factor of 6 is a
1720,1845,1970 28 1720,1845,1970 28 compromise for a range of antenna factors to
2450 28 2450 28 simplify the test.
5240,5500,5785 9 5240,5500,5785 9
WARNING!
Portable RF communications equipment (including peripherals such as antenna cables and external antennas)
should be used no closer than 30 cm (12 inches) to any part of the Constellation™ Vision System including
cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could
result.
CAUTION
Change or modifications made to this equipment not expressly approved by Alcon
may void the FCC authorization to operate this equipment.
The availability of some specific channels and/or operational frequency bands are
country dependent and are firmware programmed at the factory to match the intended
destination. This firmware setting is not accessible by the end user.
R-C-Alc-CONSTEL
Europe
Certification and Compliance Marks for Compact USB WiFi Adapter WLI-UC-GNM, as
specified in the Buffalo Technology labeling.
KOREA
Canada
IC ID: 6102A-032
ASIA PACIFIC
JAPAN
003WWA100448
TAIWAN
CCAI 10LP0720T3
WARNINGS!
The Constellation™ Vision System power cord is a medical grade power cord with
the least leakage current per foot rating available. Extension of the power cord
by hospital staff is not recommended. Unauthorized extension of the power cord
could result in injury.
Do not use multiple portable socket (power strip) outlets with this system.
Store the tray arm prior to moving the instrument. See Section Three for instructions
on placing the tray arm in the stored position.
Route the footswitch cable, power cord and other cables connected to the
Constellation™ Vision System to avoid tripping.
To avoid risk of electric shock, this equipment must only be connected to a supply
mains with protective earth (Ground).
Modification of the equipment is NOT allowed without prior authorization from the
manufacturer. If this equipment is modified, appropriate inspection and testing
must be conducted to ensure continued safe use of the equipment.
Console isolation from mains is achieved through a two pole power switch. Turn
OFF power switch or unplug the power cord from wall outlet to achieve isolation
from mains.
Verify tank pressure/facility pressure prior to surgery. If air source replacement
is needed during surgery, be sure to remove instruments from the eye and plug
cannulas as necessary. The system will revert to a backup BSS™ pressure of
30 mmHg.
CAUTION
Risk of burns and fire. Do not use near conductive materials. Renew electrode cables
upon evidence of deterioration.
Patient eye level relative to the cassette can affect the infusion pressure being
delivered to the eye. Be sure to enter the Patient Eye Level Offset to ensure that the
displayed console readings reflect the true pressure being delivered to the eye.
WARNING!
If in the medical opinion of the physician a patient with a prion related disease
undergoes a high risk procedure, the instrument should be destroyed or be
processed according to local requirements.
Vitreous Probes
Do not operate vitreous probes in air. This could result in performance degradation
and/or potential hazard.
Ultrasonic (U/S) Handpieces
The OZil™ torsional and high performance U/S handpieces are surgical instruments
and must be handled with care. The handpiece tip should not touch any solid object
while in operation. Immediately following surgery the handpiece must be thoroughly
cleaned. Be sure the cord plug is completely dry before connecting it to console. For
cleaning and sterilization procedures, see the Directions for Use (DFU) supplied with
the handpiece.
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.
If proper cleaning procedures are not performed immediately after each surgical
procedure, tissue debris and salts from irrigating solution may collect. This could
permanently damage the handpiece and could jeopardize cleanliness and/or create
biohazard conditions for the patient. Remove all debris prior to autoclaving handpiece.
The OZil™ torsional and U/S handpieces must be at room temperature just before
use. Allow the handpiece to air cool for at least 15 minutes after autoclaving; never
immerse the handpiece in liquid when hot. Power loss may occur if handpiece tip is
not securely tightened into Fragmentation and Phaco handpieces.
Ensure that test chamber is filled with BSS™ sterile irrigating solution before tuning
the OZil™ torsional and U/S handpieces. Tuning a handpiece dry may result in
premature tip failure and breakage.
Do not test or operate the OZil™ torsional and U/S handpieces unless the tip is
immersed in BSS™ sterile irrigating solution or distilled water or is in surgical use.
Irreparable damage to the handpiece and tip can result if run dry.
The phaco handpiece and INTREPID™ AutoSert™ IOL Injector must be at room
temperature just before use. Allow the handpiece to air cool for at least 15 minutes
after autoclaving; never immerse the handpiece in liquid when hot.
WARNINGS!
Use of the OZil™ torsional and U/S handpiece in the absence of irrigation flow
and/or in the presence of reduced or lost aspiration flow can cause excessive
heating and potential corneal and/or scleral burns.
Use of the Fragmentation handpiece in the absence of aspiration flow can cause
excessive heating and potential scleral burns.
Use of an ultrasonic handpiece other than the OZil™ torsional or U/S, or use of a
handpiece repaired without Alcon authorization, is not permitted, and may result
in patient injury, including potential shock hazard to patient and/or operator.
Prior to sterilization, the OZil™ torsional and U/S handpieces should always
have the connector end cap secured and placed in the sterilization tray. This will
prevent damage to the connectors and handpieces during handling, and especially
during autoclaving.
Quenching a hot handpiece in water can cause damage and will void warranty.
Be sure handpiece is completely dry before connecting it to console. Damage to
handpiece and console may result if plugged in when wet.
The U/S tips supplied in the Constellation™ Vision System packs are only to be
used on the OZil™ torsional or U/S handpieces. Each U/S tip is intended to be used
only once per case, and then disposed of according to local governing ordinances.
Good clinical practice dictates testing for adequate irrigation, aspiration flow,
reflux, and operation as applicable for each handpiece prior to entering eye.
Appropriate use of Constellation™ Vision System parameters and accessories is
important for successful procedures. Use of low vacuum limits, low flow rates,
low irrigation pressure, high power settings, extended power usage, power
usage during occlusion conditions (beeping tones), failure to sufficiently aspirate
viscoelastic prior to using power, excessively tight incisions, and combinations
of the above actions may result in significant temperature increases at incision
site and inside the eye, and lead to severe thermal eye tissue damage.
Directing energy toward non-lens material, such as iris or capsule, may cause
mechanical and/or thermal tissue damage.
Scissors, frag, and phaco handpiece tips must be fully tightened to their handpieces. If
not secured properly, the handpieces may not operate correctly. Ensure, however, that
tips are not so tight that they cannot be removed after use. Use of a tool other than tip
wrenches supplied by Alcon may cause damage to the tip and/or handpiece.
WARNING!
Use 0.9 mm tips with 0.9 mm infusion sleeves. Use 1.1 mm tips with 1.1 mm
infusion sleeves. Mismatch of consumable components and use of settings not
specially adjusted for a particular combination of consumable components may
create a patient hazard.
Poor clinical performance will result if tip is not secured tightly to the handpiece.
WARNINGS!
• The INTREPID™ AutoSert™ IOL Injector is non-sterile and must be cleaned and
sterilized prior to, and immediately after, each use.
• Never immerse the IOL injector in liquid after autoclaving; allow it to air cool for at
least 15 minutes. Quenching could result in a potentially hazardous condition for
the patient.
• The AutoSert™ IOL Injector delivery system is for the implantation of Alcon qualified
AcrySof ™ foldable IOLs. Unqualified lenses shall not be used with the system. See
INTREPID™ AutoSert™ IOL Injector DFU or AcrySof ™ IOL DFU, or contact your Alcon
representative, for qualified lens/cartridge combinations.
• The cartridge/IOL combination listed in the DFU, along with Alcon settings, has
been validated per section 5 of BS EN ISO 11979-3:2006. Appropriate use of injector
handpiece settings is important for successful IOL implantation. Inappropriate use
of settings may lead to a potentially hazardous condition for the patient.
• Fully retract plunger before detaching nosecone from AutoSert™ IOL Injector;
otherwise, this could expose non-sterile portion of shaft and result in a potentially
hazardous condition for the patient.
• For the intended IOL to be implanted, the proper Cartridge profile must be selected
from the driving console, and the proper plunger must be attached to the AutoSert™
IOL Injector. Failure to do so can result in a potentially hazardous condition for patient.
• The metal reusable plunger must be sterilized after each use. The reusable plunger
is to be installed onto the handpiece or into the wrench prior to sterilization.
To ensure safe operation of the Diathermy function, use only Alcon cables and accessories.
Diathermy performance can be guaranteed only when using Alcon Surgical components
or Alcon-endorsed components. Cables should always be positioned in such a way that
contact with the patient is prevented.
See Figure 1-4 through Figure 1-6 for diathermy power specifications.
WARNING!
• Do not use the diathermy function on patients with pacemakers or implanted
defibrillatory devices. If electrosurgery is used on patients with implanted
cardiac pacemakers or defibrillatory devices or pacemaker electrodes, be
aware that irreparable damage to the pacemaker or defibrillatory device and its
function may occur and lead to ventricular fibrillation. Please check with the
pacemaker or defibrillatory device manufacturers for their recommendations.
Listed below are general precautions to be followed when using the Diathermy function:
• To ensure safe operation of the Diathermy function, only approved cables and
accessories must be used (See your Alcon representative). Diathermy performance can
be guaranteed only when using Alcon components or Alcon-endorsed components.
• To reduce the risk of accidental burns, caution should always be taken when
operating high-frequency surgical equipment.
• Interference produced by the operation of high-frequency surgical equipment may
adversely influence the operation of other electronic equipment.
• Accessories should be checked regularly; electrode cables should particularly be
checked for possible damage to the insulation.
• The lowest power level in Diathermy step should always be selected for the
intended purpose.
• Skin-to-skin contact (for example between the arms and body of the patient)
should be avoided, for example by insertion of dry gauze.
• When HF (high frequency) surgical equipment and physiological monitoring
equipment are used simultaneously on the same patient, any monitoring
electrodes should be placed as far as possible from the surgical electrodes. Needle
monitoring electrodes are not recommended.
• In all cases, monitoring systems incorporating high frequency current-limiting
devices are recommended.
• The cables to the surgical electrodes should be positioned in such a way that
contact with the patient or other leads is avoided.
• Temporarily unused active electrodes should be stored so that they are isolated
from the patient.
• The use of flammable anaesthetics or oxidizing gases such as nitrous oxide (N2O)
and oxygen should be avoided if a surgical procedure is carried out in the region
of the thorax or the head, unless these agents are sucked away.
WARNINGS!
The illuminator bulbs become extremely hot. Never handle a bulb until it has
cooled considerably from its operating temperature. Do not touch bulb directly
with fingers at any time.
The bulb of the xenon lamp is under constant high pressure. There is a risk it may
burst with explosive force if knocked or damaged. Protective measures:
- Keep the lamp in its protective sleeve at all times during installation
- If you are handling the lamp without its protective sleeve, always wear safety
goggles, a face mask, gloves with wrist protectors and a breast protector.
If the optional illuminator is not installed inside the Constellation™ system base,
be sure that your surgical set-up includes a back-up source for illumination.
Use of controls or adjustments, or performances of procedures other than those
specified herein may result in hazardous light exposure.
To minimize hazardous light exposure, operate light source at lowest intensity
setting consistent with adequate visibility of the surgical area.
Light output from an illumination source change may greatly exceed the output
from the previous source. Adjust to lower settings after an illumination source
is changed.
Do not use this light source in the presence of flammable substances.
The fiber optic endoilluminator probe connector and receptacle may be hot.
Before each use, visually inspect the outer surface of the distal tip of the fiber
optic endoilluminator probe that will be inserted into the patient to ensure that
there are no unintended foreign materials, rough surfaces, sharp edges, or
protrusions, that may cause patient injury.
Potentially hazardous radiated light is transmitted from the fiber optic
endoilluminator probe. Refer to Retina Risk Factors to Consider During
Operation of the Constellation™ Illuminator in this section of the manual for
advice on how to minimize the effects of the light intensity used.
Avoid operation of any fiber in air on consoles capable of illumination levels
and settings higher than 10 lumens. This may result in fiber probe deformation
and/or high surface temperatures that may cause patient injury.
Never pick up or move the footswitch by holding the cable. Damage may result.
WARNING!
Route the footswitch cable properly to avoid tripping.
Manually rotating the hub roller in the cassette well when power is on and a cassette
is not installed can cause incorrect cassette loading and/or can cause injury to fingers.
WARNINGS!
All fluids aspirated during surgery should be treated as biohazards. Take appropriate
precautions when handling instruments and lines in contact with aspirated fluids.
Drain bag volume should not exceed 500 ml “Max. Capacity.” Exceeding this
volume may result in a biohazardous condition.
WARNING!
Potential risk from reuse or reprocessing the following products labeled for single
use include:
• Bipolar Coagulation Instruments - Thermal injury or electrical shock caused by
a damaged bipolar instrument, and foreign particle introduction into the eye.
• Fiber Optic Instruments - Phototoxicity from inconsistent laser or illumination
exposure caused by a damaged fiber or connector, reduced laser/illumination
output, and foreign particle introduction into the eye.
• Fluid Management Components - Fluid path leaks or obstruction resulting in
reduced fluidics performance, and foreign particle introduction into the eye.
• Phacoemulsification Tips - Reduced tip cutting performance, presence of tip
burrs, fluid path obstruction, and foreign particle introduction into the eye.
• Vitreous Cutting Instruments - Reduced vitreous cutting performance, fluid
path obstruction, and foreign particle introduction into the eye.
WARNING!
Attach only Alcon supplied consumables to console and cassette luer fittings. Do
not connect consumables to the patient's intravenous connections.
By Phone:
In USA: (800) 757-9780
International: Contact your local Alcon representative.
By E-mail: http://www.alcon.com/contact-us/
The closed loop system that adjusts IOP cannot replace the standard of care in judging
IOP intraoperatively. The surgeon must continue the common practice of informally
judging IOP using the following:
• Finger palpation on the globe
• Tactile feedback of the surgical instruments (eye wall deformation with
manipulation of instruments)
• Retinal vessel perfusion/pulsations
• Presence of corneal edema
If the surgeon believes the IOP (using the techniques above) is not responding to the
system settings and is dangerously high, this may represent a system failure. The
surgeon can do one or more of the following as they deem appropriate in this situation
(with care to avoid sudden hypotony):
• Close the infusion stop-cock
• Pinch the infusion line
• Remove the infusion line from the sclerotomy
The footswitch, endoprobe, and LIO should be placed within 2 meters of the
Constellation™ Vision System.
WARNINGS!
There are potential hazards when inserting, steeply bending, or improperly securing
the fiberoptic. Not following the recommendations of the manufacturer may lead
to damage of the fiber or delivery system and/or harm to the patient or user.
Since the aiming beam passes down the same delivery system as the treatment
beam, it provides a good method of checking the integrity of the delivery system.
If the aiming beam spot is not present at the distal end of the delivery system,
or its intensity is reduced or it looks diffused, this is a possible indication of a
damaged or not properly working delivery system. If there is any doubt, contact
Alcon Technical Services.
The use of flammable anesthetics or oxidizing gases such as nitrous oxide (N2O)
and oxygen should be avoided. Some materials - for example cotton wool when
saturated with oxygen - may be ignited by the high temperatures produced in normal
use of the laser equipment. The solvents of adhesives and flammable solutions
used for cleaning and disinfecting should be allowed to evaporate before the
laser equipment is used. There is also danger of ignition of endogenous gases.
In the past, some of Alcon’s products have referred to the feature “Cautery” or
"Coagulation." The Constellation™ Vision System and this operator's manual use the
word “Diathermy” based on the following definitions:
Operators experiencing problems with the system should refer to the Operating
Instructions and Troubleshooting sections of this manual. A problem which persists
should be referred to the Alcon Technical Services Department or your local
authorized service representative.
Safety performance should be verified by the user (e.g., qualified service personnel)
at least twice a year. Ground resistance must be under 0.1 ohms. Leakage current
must be under 500 µA at 264 Vac or 300 µA at 132 Vac.
Alcon Laboratories, Inc., will repair or replace at its option, any system or
accompanying accessories (excluding the optical fiber) found to be defective in
material and/or workmanship for a period of one (1) year from the date of initial
installation. If optional laser is included, the laser core module will be warrantied
one (1) year from the date of initial installation. This warranty applies to the original
purchaser of the system, when said system is properly installed, maintained, and
operated in accordance with published instructions.
Alcon Laboratories shall not be obligated to provide services under this warranty for
damage to or destruction of systems covered where such damage or destruction is (i)
a result of or caused by fire or explosion of any origin, riot, civil commotion, aircraft,
war, or any Act of God including, but not limited to lightning, windstorm, hail,
flood, earthquake, or (ii) caused by customer’s misuse or improper servicing of said
systems.
This warranty does not cover damage resulting from service repair or other alteration
by any person other than an Alcon-authorized service person, and any warranties
provided by Alcon with respect to this equipment shall become void and of no further
force and effect if this equipment is serviced by anyone other than Alcon-authorized
service personnel. In particular, Alcon shall have no obligation to replace, repair or
credit customer’s account for the cost of the equipment, which has been subject to
service or other alteration by persons other than Alcon-authorized service personnel.
The express warranty above is the sole warranty obligation of Alcon, and the
remedy provided above is in lieu of any and all other remedies. There are no other
agreements, guarantees, or warranties - oral or written, express or implied - including
without limitation warranty of merchantability or fitness for a particular purpose.
Alcon shall have no liability whatsoever for any incidental or consequential damages
arising out of any defect, improper use, or unauthorized service or repair.
WARNING!
The disposables used in conjunction with Alcon instrument products constitute
a complete surgical system. Use of disposables and handpieces other than those
manufactured by Alcon may affect system performance and create potential
hazards. If it is determined that disposables or handpieces not manufactured
by Alcon have contributed to the malfunction of the equipment during warranty
period, service will be provided at prevailing hourly rates.
Spectral Output
The Constellation™ illuminator comes equipped with internally-integrated, non-
selectable, UV/IR filtration. No removable filters are used in the Constellation™
illuminator since the retinal hazard is maintained at the levels specified by ISO
15752-2000.
Output Limits
To avoid potentially unsafe operations of the Constellation™ illuminator, the
system will warn or prevent the user when certain thresholds are exceeded. The
Constellation™ illuminator limits output and aphakic weighted irradiance to stay
within safe limits based on the type of fiber used. Using RFID, the type of fiber is
detected by reading information from the RFID tag within the inserted fiber probe.
Utilizing the fiber type information the Constellation™ illuminator sets a series of
limits on output. Four separate thresholds are used:
Damage Limit - The Damage Limit corresponds to the maximum output of the
illuminator that any given RFID recognized fiber can be safely operated without
risking damage to the probe while operation in air. When the intensity of the output
of the Constellation™ illuminator is increased by the user beyond the damage limit,
a pop up message is displayed that warns the user “Further increasing the output
level in air can damage fiber tips. Would you like to continue?” If the user presses
the [Yes] button, the request (turning on illuminator, changing the set point while
the illuminator is on, or changing procedures while the illuminator is on) will be
granted. If the user presses the [No] button, the system state will be unchanged. No
interactions with the illuminators are allowed while the advisory is being displayed
Hard Limit - The Hard Limit for any given RFID recognized fiber corresponds to
a peak aphakic weighted irradiance of 115.85 mW/cm2 for a nominal fiber optic
endoilluminator probe at a distance of 5 mm from the exiting aperture. The displayed
intensity percentage output of the Constellation™ illuminator is scaled so that 115%
corresponds the Hard Limit for that fiber. The user is not given the ability to exceed
this limit.
The following information is given to provide the operator with specific information
regarding the Constellation™ Vision System Laser ophthalmic laser.
Indications
The Constellation™ Vision System Laser is indicated for use in photocoagulation of
both anterior and posterior segments of the eye including:
• A qualified technician must verify that the power plug used is properly grounded.
• The remote interlock connector should be connected to an emergency master
disconnect interlock or to room/door/fixture interlocks. Please refer to Figure 1-7.
• The laser footswitch, endoprobe, and LIO should be placed within 2 meters of the
Constellation™ Vision System Laser.
CAUTION
Before turning the instrument ON for the first time after receipt of the system, wait one
hour for the components and optics to normalize to avoid possible condensation that
may have occurred during shipping.
REMOTE
CONNECT
1
CUSTOMER SUPPLIED
DOOR SWITCH (OPTIONAL)
6
9-PIN D-CONNECTOR
1
COM
TO DRIVE DOOR LAMP (OPTIONAL)
NC NO 9
3
The Constellation™ Vision System Laser is fitted with the following safety systems
which must be understood by every operator:
• A protective housing covers the laser source so that no harmful laser radiation will
be emitted. No part of this protective housing should be removed by the operator.
The laser system must not be used if the protective housing has been damaged or
removed.
• A remote connection (interlock) is located on the rear panel and permits the
installation of an external switch. This switch can be installed on the laser room
door and cuts off all laser emissions in case the door is opened during operation.
There is also a connector linked to an internal relay to activate a door warning
lamp if desired.
• A key switch controls the laser power supply. Laser operation is not possible if
the key has been removed. Access to the key should be limited to authorized and
knowledgeable personnel. The key should not be left on or near the instrument
when not in use.
• During operation, laser status can be determined by visually checking the display
to determine the laser mode: Standby or Ready.
• An emergency switch is mounted on the front panel. Pushing this switch will cut
off all laser emissions (treatment and aiming beam) at any time. The switch must
be pulled out to the initial position to restore power. The laser will always restart
in Standby mode.
• Laser firing commands are microprocessor controlled and firings are prevented
should any malfunction be detected in the instrument electronics. The instrument
will only fire when all conditions are correct.
• Output power of the laser beam is continuously monitored and controlled. In
case an unusual power condition is detected, firing stops and the treatment laser
emission is cut off.
The 532 nm green laser beam has similar absorption characteristics to the 577 nm dye
yellow laser beam7. This means that the absorption effects of the 532 nm wavelength
are considerably higher in hemoglobin and melanin, and less in xanthophyll. In
all cases, it is necessary to perform titrations until the desired treatment results are
obtained. The 532 wavelength also requires less power than that required with the
argon laser to obtain similar results. Therefore, you should begin your titration levels
with lower power than required for similar procedures with the argon laser.
WARNING!
Failure to titrate delivered energy may result in patient injury.
Use of this medical laser, as with any other instrument, requires training and
experience to obtain maximum clinical performance. Titrating the dosage is
recommended by initiating a lesion formation in an area of normal retina with intact
pigment epithelium. Power and exposure duration should be varied incrementally
until the desired lesion is produced.
WARNING!
If unsure which settings are required, select low power, short duration, and large
spot size. Failure to do so may result in patient injury.
The pigmentation of the eye, technique or procedure used, laser settings, and pre-
existing condition of the eye, such as cataract, will have an effect on the selected laser
parameters and the results obtained. Therefore, it is very important to consider all the
existing clinical conditions and titrate until the desired results are obtained.
The doctor protection filter must remain in the beam path during treatment, enabling
the targeted tissue to be seen with complete protection for the operator. The filter has
virtually no effect on visualization (colored† view only).
Rotation of the tethered filter with manual switch in or out of the beam path is
accomplished by means of a lever located on the right side of the filter. Note that if
the doctor protection filter is in the open position in endo modes, the laser will not
fire and the message “Please Engage Dr. Filter” will appear. Rotate the filter lever
clockwise until the doctor protection filter is in the beam path and the message clears.
If using a non-tethered fixed filter, and the system is switched from Standby to Ready
mode, the message "Verify appropriate Dr. Filters are installed in all viewing devices"
appears and the user must verify before the laser can switch to Ready mode.
If two tethered filters are in place (see rear panel description), both filters must be
switched into the beam path before the laser will operate. Switching either filter
out of the beam path while the laser is in Ready mode switches the laser to Standby
mode immediately. Inserting a filter tether into the machine while it is in Ready
mode switches the machine back to Standby mode until all tethered filters have been
verified to be in place.
WARNING!
Do not attempt treatment if aiming beam is not present. Patient injury may occur.
The aiming beam passes down the same delivery system as the working beam;
this provides a good method of checking the integrity of the delivery system. If
the aiming beam spot is not present at the distal end of the delivery system, if
its intensity is reduced, or if it looks diffused, these are possible indications of a
damaged or not-properly-working delivery system.
† Newer Doctor Protection Filters will have less tint than older ones.
Treatment Hazards
A single treatment exposure will typically cause a blanching of target tissue. Exposure
duration can be adjusted from 0.01 seconds to 2.0 seconds to result in the desired
effect. A continuous treatment beam can also be selected.
NOTE: In CW, depending on the thermal load of the system, the system may
shut down in safety mode prior to the footswitch being released.
Contra Indications
Patients with a condition that prevents visualization of target tissue (cloudy cornea,
or extreme haze of the aqueous humor of the anterior chamber or vitreous humor) are
poor candidates for LIO delivered laser treatment.
Side Effects
Corneal burns, inflammation, loss of best-corrected visual acuity, loss of visual field,
and transient elevations in intraocular pressure can occur as a result of ophthalmic
laser treatment. Unintentional retinal burns can occur if excessive treatment beam
power or duration is used.
Laser Safety
Back scattered radiation is of low intensity and is not harmful when viewed through
a protective filter. All personnel in the treatment room must wear protective eyewear,
OD 4 or above at 532 nm, when the system is in Standby/Ready mode as well as
during treatment. The doctor protection filter is an OD greater than 4 at 532 nm.
WARNING!
Use of controls or adjustments or performance of procedures other than those
specified herein, may result in hazardous laser radiation exposure.
CAUTION
Federal (USA) law restricts this device to sale by, or on the order of, a physician.
1 Ludwig, K.; Lasser, T.; Sakowski, H.; Abramwoski, H.; Worz, G. (Augenklinik,
Universitat Munchen) "Photocoagulation in the edematous and non-edematous
retina with the cw-laser of different wavelengths." Ophthalmologe (GERMANY),
December 1994, Volume 91, No. 6, p783-788.
2 Roider, J.; Schiller, M.; el Hifnawi, E.S.; Birngruber, R. (Augenklinik,
Medizinische Universitat zu Lubeck) "Retinal photocoagulation with a pulsed,
frequency-doubled Nd: YAG laser (532 nm)." Ophthalmologe (GERMANY),
December 1994, Vol. 91 No. 6, p777-782.
3 Wyman, D.; Wilson, B.; Adams, K. (Medical Physics Department, Hamilton
Regional Cancer Centre, Ontario, Canada) "Dependence of laser photocoagulation
on interstitial delivery parameters." Lasers Surgical Medical (UNITED
STATES), 1994, Vol. 14 No. 1, p59-64.
4 Obana, A.; Miki, T.; Matsumoto, M.; Ohtsuka, H.; Moriwaki, M.; Kamo, M.;
Mii, T.; Kijima, M. (Department of Ophthalmology, Osaka City University,
Medical School, Japan) "An experimental and clinical study of chorioretinal
photocoagulation using a frequency-doubled Nd: YAG laser." Nippon Ganka
Gakkai Zasshi (JAPAN), September 1993, Vol. 97 No. 9, p1040-1046.
5 Mordon, S.; Beacco, C.; Rotteleur, G.; Brunetaud, J.M. (INSERM - National
Institute of Health and Medical Research - Lille, France) "Relation between skin
surface temperature and minimal blanching during argon, Nd-YAG 532, and CW
dye 585 laser therapy of port-wine stains." Lasers Surg Med (UNITED STATES)
1993, Vol. 13 No. 1, p124-126.
6 Jalkh, A.E.; Pflibsen, K.; Pomerantzeff, O.; Trempe, C.L.; Schepens, C.L. (Eye
Research Institute of Retina Foundation, Boston, MA 02114) "A new solid-
state, frequency-doubled neodymium-YAG photocoagulation system." Arch
Ophthalmol (UNITED STATES) June 1988, Vol. 106 No. 6, p 847-849.
7 Wavelengths, Opthamology, July 1986, Volume 93, Number 7, Page 956.
INTRODUCTION
The Constellation™ Vision System is a multi microprocessor-controlled ophthalmic
surgical instrument with associated memory and input/output (I/O) circuitry.
The system communicates with the user via its Front Panel display, with voice
confirmations, and with tones.
An automatic self-test is initiated each time the system power is turned on. If the
system does not pass the self-test, either a Fault screen or an error message is
displayed depending upon the cause of the issue. When the system successfully
completes the self-test, it automatically goes into the Setup mode.
This section of the manual describes the system hardware, the user interface, and the
accessories that may by used with the system.
FRONT PANEL
Fluidics Module
The fluidics module is located in the center of the front panel. The module allows fast
and easy insertion of the cassette that contains all the fluidics connections required for
surgery.
WARNING!
Connect only Alcon supplied consumables to console/cassette connectors. Do
not connect consumables to patient intravenous connections.
WARNINGS!
The maximum allowable load on the instrument tray is 20 lb (9 kg). If the load
exceeds this limit, the tray arm will automatically lower itself in order to avoid
tipping the system over. Additionally, if the instrument tray is positioned over a
patient, a mayo stand should be placed beneath it to avoid a potential collapse
of the tray arm onto the patient.
Place the instrument tray in the stored position as shown in Figure 2-1 prior to
transportation to avoid a situation that could cause the system to tip.
WARNING!
Do not use Legacy™ IV pole extender with Constellation™ Vision System IV pole.
Instrument Tray
(optional)
Fluidics Module
Laser Module
(optional)
Auxiliary Illumination
(optional)
Footswitch
Footswitch
Connector
Multi-Function Port
Scissors
UltraVit™ Probe/
Diathermy HyperVit™ Probe
CAUTION
The system must be moved carefully, otherwise the system could tip over and become
damaged. Do not push or pull the unit by the display, the tray, or the IV pole. Handles
located at the rear and sides of the unit are provided for moving the instrument. The
unit should be pulled and not pushed, especially over elevator and door thresholds.
Standby Switch
External Connector
Panel (see Detail B on
next page)
Power Module/Footswitch
Main Power Switch Connector (behind panel)
DETAIL A
Dr. Filter
Laser
Status
Remote
Interlock
Laser
Footswitch
Barcode
Reader Video Overlay
HDMI Out (optional)
Tethered Laser
(for connection to Alcon RS-232 Video Recorder
PurePoint™ laser system only) (for connection to Sony
Medical Grade DVD Recorder
DETAIL B-2
Video Overlay
S-Video In (optional)
Barcode
Reader
Video Overlay
Tethered Laser HDMI Out (optional)
(for connection to Alcon
RS-232 Video Recorder
PurePoint™ laser system only)
(for connection to Sony
Medical Grade DVD Recorder
Barcode
Reader
Composite Video Out (optional)
Tethered Laser Video Overlay S-Video Out (optional)
(for connection to Alcon
PurePoint™ laser system only) RS-232 Video Recorder
(for connection to Sony
Medical Grade DVD Recorder
CAUTION
The USB connectors ( ) and service ethernet connector located on the rear
panel are for use by Alcon trained personnel only. Failure to comply will void
warranty.
Generally, the treadle is used to provide control of a parameter, such as vacuum, with
the treadle's angle of depression proportional to the parameter output. In some modes
of operation, the treadle is used to provide on/off control of a function, with any
depression resulting in a fixed output of its parameter.
Right and left switches are used to enable and disable system functions. The switches
are nudged sideways (horizontal) for some functions, and pressed down (vertical) for
others.
The tension adjustment knob, located on the front of the footswitch, is used to adjust
the pressure needed to depress the treadle.
CAUTION
Never pick up or move the footswitch by holding the cable. Damage may result.
Handle
Treadle
Tension Adjustment Knob
(not shown)
Right Horizontal/Vertical Switch
NOTE:
The Constellation™
footswich does not
fire the optional
laser. Right Heel Switch
Handle
WARNING!
The Alcon remote control is common to several Alcon instruments. To keep the
remote from interfering with other Alcon instruments, each remote control must
be set to match the unique channel (A, B, C, or D) of its associated instrument.
Changing batteries will cause the remote to default to channel A; therefore the
remote may need to be reset to the instrument's unique channel as described in
"Selecting Remote Control Channel" on page 2.11.
CAUTION
Do not sterilize the remote control as it will damage the unit.
Figure 2-4 shows the Remote Control and the keys provided. When a Remote Control
Transmitter key is pressed, the Constellation™ Vision System console determines whether
or not the key press was valid and generates an appropriate valid or invalid key tone.
Parameter Value
Adjustment Keys
Surgery Screen
Navigation Keys:
Left/Right; Up/Down
Enter Key
The Remote Control is divided into three sections from top to bottom. The three
sections of the display screen are 1) the top section is for Global Selection and
adjustments of global values, 2) the main (middle) window is for surgery screen
navigation and parameter settings, and 3) the bottom section is for selecting steps
and enabling/disabling selected controls. Some items on the Constellation™ Vision
System console display screens are not accessible with this Remote Control unit.
CAUTION
Do not sterilize the remote control Figure 2-5 Remote Control Channel Selection
as it will damage the unit. Screen (Options\System\Remote Control tab)
The Constellation™ Vision System emits an audible tone to indicate button activation.
Activation of a valid touchscreen button or remote control button results in a valid
key tone; an invalid button results in an invalid key tone, and, in some circumstances,
its icon symbol is ghosted to indicate an invalid function.
There are four types of display screens: the Setup screen, Surgery screens, End Case,
and Popups (sometimes referred to as dialogs).
• The Setup screen is used to prepare for surgery; i.e., connecting instruments,
priming the fluidic management system and testing the handpiece.
• Surgery screens contain surgical settings for each of the current surgical
procedures. Settings can be adjusted by pressing the touch screen buttons for the
associated controls.
• The End Case screen provides the user with a summary of the case and a tabbed
interface area for display of the various metrics associated with the case.
• Popups are displayed as a result of selecting an option from the Options drop list
(i.e., System Settings, Doctor Settings, etc.) or pressing the Footswitch button.
Popups enable the user to view and modify system settings, doctor settings, and
some surgical settings. There are also popups displayed to advise or warn the user
of a situation, or to indicate progress on a function in the Setup screen.
Startup Screen
Upon power-up of the system, an introductory screen is displayed as shown in Figure
2-6 while the system completes initialization and self-test diagnostics. All user inputs
are locked out while this screen is displayed. If initialization is successful, the main
screen is displayed as shown in Figure 2-7.
MENU BAR
Footswitch
Icon
Doctor Selection
The Doctor list shows the names of all available doctors with the "Default Doctor"
first and the other doctors listed in alphabetical order. Selecting one of the entries then
pressing the Close button will change the currently selected doctor, update the current
procedure, and – if in surgery – the current step. The Default Doctor comes with a set
of default procedures that cannot be modified.
New doctors can be added to the list by pressing the “ Add” button in the Doctor
section. When this button is pressed, a keyboard is displayed allowing the user to
enter a new doctor. The new doctor is automatically selected if the name is valid (the
name cannot be more that 40 characters or a duplicate name). If the name is identical
to a doctor already in the system, an advisory is displayed when attempting to Save
the new doctor and, upon pressing the Advisory "OK" button the user will be returned
to the new doctor entry screen.
NOTE: Doctors cannot be deleted from the Doctor & Procedure Selection
popup. To delete a Doctor or Procedure, go to the Options popup and select the
View/Copy/Delete option (covered in detail later in this section of the manual).
Procedure Selection
The Procedure list shows all available procedures for the current doctor starting
with the Accurus™ Classic procedure followed by an alphabetically sorted list of
procedures created for that doctor. The currently selected procedure is highlighted.
To select another procedure, simply press the desired procedure which will become
highlighted.
At the right of the Procedure list are three buttons that enable the user to Add, Save,
and Modify procedures. Pressing "Add" or selecting a procedure and pressing the
"Modify" button will open the Modify Procedure dialog as shown in Figure 2-9.
The Surgery Steps panel displays a list of steps that can be added to the Procedure
panel either by selecting a step and pressing the "Add to Procedure" button or by
drag-and-drop functionality (press a step and drag down to the Procedure panel).
In the default "View All" view, a scrollable list of steps is displayed based on the
selected filter. The following actions can be taken in this view:
• Pressing the "Filter" button displays the Step Filtering dialog where the displayed
steps can be filtered as desired by the user. In the Step Filter dialog, pressing
"Close" applies the changes made and pressing "Cancel" closes the dialog without
changing the current display filter.
• Pressing the "Add Favorite" button adds the currently selected step to the "View
Favorites" view of steps (for the current doctor) and the panel will automatically
switch to the View Favorites view. NOTE: When adding steps to Favorites, a
copy of the step is made and added. It is not a reference to the original step.
Any changes made to the original step will not carry over to the favorite.
• Pressing the "Add to Procedure" button adds the currently selected step to the
Procedure panel.
• Pressing and dragging a step to the Procedure panel.
Pressing the "View Favorites" tab changes the view to show the favorite steps of the
currently selected doctor. Each doctor has a set of favorite steps consisting of one step
per surgery mode: Phaco, I/A, AutoSert, Fragmentation, Vitrectomy, Extrusion, Laser,
Scissors, Forceps, and VFC. The following actions can be taken in this view:
• Pressing the "Add to Procedure" button adds the currently selected step to the
Procedure panel.
• Pressing and dragging a step to the Procedure panel.
When a step is added to the current procedure in the Procedure panel, the Step Name
dialog is displayed where the step name may be changed before it is displayed in the
Procedure panel. Pressing the "Close" button accepts the new name or the default
name if no change was made.
The Procedure panel shows the surgical steps in the current procedure that is being
created or modified. The following actions can be taken in this panel:
• Pressing the "Rename Step" button displays the Step Name dialog where a new
name for the step can be entered or selected.
• Pressing the "Delete Step" button removes the selected step from the procedure.
Pressing and dragging a step to the trash can will also remove the step from the
procedure.
• Pressing the "Add Favorite" button adds the currently selected step to the "View
Favorites" view of steps (for the current doctor) and the Surgery Steps panel will
automatically switch to the View Favorites view. NOTE: When adding steps to
Favorites, a copy of the step is made and added. It is not a reference to the
original step. Any changes made to the original step will not carry over to the
favorite.
When the Close button is pressed on the Modify Procedure dialog, after adding steps,
the new or modified procedure will be the current procedure. Changes to a modified
procedure are not permanently saved unless the Save button is pressed in the Doctor
& Procedure Selection Dialog.
The Vitreous Probes (Posterior and Anterior), Frag Tip, and I/A Tip selections provide
a drop down list of options available to set as the default. The selection here will be
the default option displayed on the Setup screen for that probe or handpiece.
The Phaco and OZil™ Tip selections allow the user to define a subset (preferred) list
from the available handpiece tips. The selected tips become the list displayed in the
Setup Handpiece panel, the Select Handpiece Tip dialog (in the Setup dialog), and
the Phaco/OZil™ Tip Selection list (accessed via the surgery screen). The Preferred
(default) drop-list only contains tips selected in the Preferred List. The tips are added/
removed from the Preferred drop-list using the following Preferred List criteria:
• When an item is checked, it will appear in the Preferred drop-list.
• When an item is unchecked, it will not appear in the Preferred drop-list.
• An item currently displayed as the ‘Preferred’ default in the drop-list cannot be
unchecked.
• Load Plunger Prompt - This selection determines whether the Load Plunger or the
Preload Lens button receives emphasis when the IOL Setup Panel or AutoSert™
Setup dialog is displayed.
• Full Extension Offset - This feature is used to adjust the full extension position at
which the AutoSert™ IOL injector stops moving forward. The adjusted position is
defined in millimeters relative to the maximum extension position. At the default
setting (0) the AutoSert™ IOL injector is at its maximum extension.
Time
Repeat
OZil™ Torsional Before Phaco
Time
Repeat
Phaco Before OZil™ Torsional
NOTE: When mapping the footswitch button actions to perform diathermy, the
horizontal switches do not meet the specification of minimum activation
force of 2.25 pounds. It is not in accordance to the governing standards,
to have the diathermy activation mapped to the horizontal switches.
There are four footswitch actions available for the optional NEGENUITY™ system:
• NEGENUITY™ Image Orientation - Toggles the image orientation between
standard and inverted. This action is also available in the NEGENUITY™ Setup
screen.
• NEGENUITY™ Menu- Displays the popup menu on the NEGENUITY™ display.
This action is also available in the NEGENUITY™ Setup screen.
• NEGENUITY™ Auxiliary - This action is configurable from the NEGENUITY™
system. Refer to the NEGENUITY™ operator's manual for details on its
configuration.
• Toggle Video Recording - This action will toggle video recording for either the
NEGENUITY™ system or an Alcon approved video recorder (see Section Three).
ANTERIOR
Left Left Right Right
Mode Submode Left Heel Right Heel
Vertical Horizontal Vertical Horizontal
Next Submode/ Infusion/FAX Continuous
3D Diathermy Reflux Next Step
Previous Step Alt/Reg Toggle Irrigation Toggle
Next Submode/ Irrigation Alt/ Continuous
Burst Diathermy Reflux Next Step
Previous Step Reg Toggle Irrigation Toggle
Next Submode/ Irrigation Alt/ Continuous
Phaco Custom Diathermy Reflux Next Step
Previous Step Reg Toggle Irrigation Toggle
Next Submode/ Irrigation Alt/ Continuous
Pulsed Diathermy Reflux Next Step
Previous Step Reg Toggle Irrigation Toggle
Next Submode/ Irrigation Alt/ Continuous
Continuous Diathermy Reflux Next Step
Previous Step Reg Toggle Irrigation Toggle
Next Submode/ Irrigation Alt/ Continuous
I/A -- Diathermy Reflux Next Step
Previous Step Reg Toggle Irrigation Toggle
AutoSert™
AutoSert™ -- Diathermy Previous Step No Function No Function Next Step
Retract
Next Submode/ Irrigation Alt/
Wet Ant Diathermy Reflux Cut Toggle Next Step
Previous Step Reg Toggle
Vit
Next Submode/ Irrigation Alt/
Vit Dry Diathermy Reflux Cut Toggle Next Step
Previous Step Reg Toggle
Non Irrigation Alt/
-- Diathermy No Function No Function No Function No Function
Surgical Reg Toggle
Footswitch Configuration
The Footswitch Configuration setting allows the user to enable the side switches to
control laser power and transition the system between Ready and Standby. Three
options are available as follows:
Standard
This setting disables the side switches entirely. Power control and switching from
Standby to Ready mode can only be done from the front panel of the system.
Pressing the Scan button prompts the system to refresh the “Available WIFI
Networks” list.
Example of screen
that overlays the live
video displayed on an
external monitor or
the NEGENUITY™
system.
WARNING!
Be sure to connect gas bottles to the proper connectors. Bottle valves, tubing,
and connectors are color coded as follows: C3F8 = Red, SF6 = Blue.
1. Make Gas Selection: C3F8 or SF6 - Gas bottle(s) are connected to system
through the mechanical regulator valve located at the back of the console.
2. Press Start To Begin Filling - Press the “Start” button to start filling the syringe
with the selected gas type. The button is initially disabled and is only enabled during
the time period between a gas selection and the commencement of a fill operation.
Fill Progress - Displays the status of the fill process. After the process is
complete, the number of purge cycles is displayed. The number of purge cycles is
set in the System Setting screen (Options\Settings\System) and has a range from 1
to 3 cycles. The number of purge cycles affects the gas concentration percentage
in the Auto Gas Fill syringe according to the following table.
The status bar graphically illustrates the progress of the fill operation. If
necessary, press the Stop button to stop filling the syringe in the middle of a fill
cycle. The button is initially disabled and is only enabled during a fill operation.
When the fill operation is complete, System Advisory 1401 is displayed as shown
in Figure 2-28. This advisory is a reminder that the gas in the syringe is undiluted
and additional steps must be manually taken in order to achieve the desired Gas
Mix Ratio.
The Gas Mix Ratio Guide is a tool to assist the user in calculating the syringe volume
adjustments required in order to achieve the desired mixture.
WARNING
Adjusting the Gas Mix Ratio Guide does not automatically fill the syringe to the
desired mixture. The user must manually move the plunger to make the gas volume
adjustment in the syringe after detaching the syringe assembly from the console.
To achieve a specific gas/air mix ratio (after the system has purged then filled the
syringe to 20cc of gas), use the Gas Mix Ratio Guide as follows:
1. Move the slider on the guide to the desired percent of gas mixture. The guide
displays the syringe reading that the plunger must be moved to in order to achieve
the displayed percentage of gas in the syringe (18% -> 10.8 cc in Figure 2-28).
2. For an 18% gas mixture, push the plunger from 20 cc to 10.8 cc. Then pull the
plunger out to 60 cc. The resulting mixture will be 18% of the selected gas.
NOTE: Refer to the Directions For Use (DFU) included with Auto Gas Filler
Pack for detailed setup instructions.
Scroll
Arrows
Copy Data
Button
The Source tab of this screen shows information about the media used as the
source of a data management or copy operation. The Destination section shows the
information for the media used as the targeted location to move data to. Each section
shows the media options available to manage data. To select a media option, simply
press the selection and the display will show the current contents in a hierarchal
structure. The media options are:
• System – Refers to the local Constellation™ Vision System file.
• CD/DVD – Removable media.
• SD-Card – Removable Media card.
If CD/DVD or SD-Card are selected and neither is inserted into the system, a popup
will appear indicating that no media has been detected and prompting the user to
insert a valid media.
The Data Structure Tree displayed after media selection allows the user to rename,
delete, view, or print the selected item. If any of these operations can be performed on
the item, the associated button, located at the bottom of the screen, will have a dark
background color. There are items such as "Default Doctor" that cannot be renamed
or deleted.
If an item has additional items below it in the structure, selecting it will expand the
structure and selecting again will collapse the structure. If the structure tree expands
beyond the screen limits, scroll arrow are available in each corner to scroll to hidden
parts of the structure.
To Rename an item:
1. Press the item to select it then press the Rename button. Only doctor names,
procedure names, and surgical end case data items can be renamed.
2. When the Keyboard popup appears, press the Backspace key or the Clear key to
delete the current name then type in the new name.
3. Press Close to save the name and return to the previous screen. Pressing Cancel
will close the keyboard popup without saving the changes.
To Delete an item:
1. Press the item to select it then press the Delete button. Some items cannot be
deleted such as the Default Doctor.
2. When the confirmation popup appears, press Yes confirm or No to cancel the
delete action.
To print a detailed report of an item, select the item then press the Print button.
A popup will be displayed indicating that the report is being sent to the printer
connected to the system. Printouts of data are identical to the layout of a reports
displayed using the View button.
COPYING DATA
Copying data between the source device and destination device is performed by first
selecting a source data item and then pressing the Copy Data button. When pressed,
the source data item is copied to the destination device at the same location defined
by the source data item (i.e., the hierarchy is preserved).
To finish the process of copying data to a SD Card or a CD/DVD, the Write button
must be pressed. If there is not enough space on the remote disk, you will be
prompted to remove some items and try again.
If an attempt is made to copy a file that already exists on the destination device, a
popup will be displayed indicating the file already exists and the following options
are available:
• Overwrite - Replaces the destination file with the new source file.
• Copy - Selecting Copy opens the keyboard popup so the user can rename the file.
The old file is not overwritten in this case.
• Cancel - Stops the Copy process with no changes.
• Skip - This button is displayed only when copying multiple doctors that have
already been saved to the destination. Pressing the Skip button skips the current
doctor listed in the upper left corner of the popup and moves to the next doctor.
Patent information for the Constellation™ Vision System is displayed by pressing the
Patents button.
Video Help
Wizard Help
NEGENUITY™ menu
control footswitch mapping
is shown here. The system
reverts to the current
Constellation™ footswitch
mapping when the dialog
is closed or the Hide
Menu button under the
Commands tab is pressed.
Viewport Tab - The Viewport tab shown in Figure 2-36 contains selections
to configure the format to be used for displaying multiple viewports on the
NEGENUITY™ 3D flat panel display. NOTE: The secondary viewport must
be connected and configured on the NEGENUITY™ system (refer to the
NEGENUITY™ operator's manual for additional information).
• Secondary View: Off - Turns off the Secondary Viewport display mode on the flat
panel main view.
• Secondary View: Split Screen - Divides the flat panel main view into half screen
areas for each of the two different video sources.
• Secondary View: Full Screen - The main view shows the secondary video source
full screen.
• Secondary View: PIP - Used to position the Picture-in-Picture (PiP) viewport into
the corner of the flat panel main view.
• Swap Sources: Swap - Used to switch between two different video sources on the
flat panel main view.
Commands Tab - The Commands tab shown in Figure 2-37 allows the user to
control and interact with the popup menu displayed on the NEGENUITY™ 3D flat
panel display. This menu can be activated from the footswitch if a button is mapped
with the "NEGENUITY™ Menu" command. To map a button, go to Options/Doctor
Settings/Footswitch.
• Menu: Show - Shows the popup menu on the NEGENUITY™ 3D flat panel display.
• Menu: Hide - Closes the popup menu on the NGENUITY™ 3D Flat panel display.
• Navigations/Selection: Previous - Navigates to the previous menu item.
• Navigations/Selection: Next - Navigates to the next menu item.
• Navigations/Selection: Select - Selects the current menu item.
Navigation between the System States is associated with certain rules as stated in
Table 2-2:
The availability of the Infusion, FAX, and Irrigation global controls depends upon the
type of cassette inserted into the system as follows:
CASSETTE TYPE INFUSION FAX IRRIGATION
Premium Combined Yes Yes Yes
Premium Posterior Yes Yes No
Premium Anterior No No Yes
WARNING!
The closed loop system that adjusts IOP cannot replace the standard of care in
judging IOP intraoperatively. The surgeon must continue the common practice
of informally judging IOP using the following:
• Finger palpation on the globe
• Tactile feedback of the surgical instruments (eye wall deformation with
manipulation of instruments)
• Retinal vessel perfusion/pulsations
• Presence of corneal edema
If the surgeon believes the IOP (using the techniques above) is not responding to
the system settings and is dangerously high, this may represent a system failure.
The surgeon can do one or more of the following as they deem appropriate in this
situation (with care to avoid sudden hypotony):
• Close the infusion stop-cock
• Pinch the infusion line
• Remove the infusion line from the sclerotomy
Infusion Source
Elevated Infusion Timer
IOP On/Off Button
Decreases Value Button
(Only displayed when IOP is
enabled-see Options menu)
Infusion Flow
Infusion Flow Units
More
Information
Proportional
More
Information
Illumination
Units
Selection
buttons
More Information
WARNING!
To minimize hazardous light exposure, operate light source at lowest intensity
setting consistent with adequate visibility of the surgical area.
CAUTION
Avoid prolonged operation of any fiber optic endoilluminator probe in air. This may
result in tip deformation of plastic fiber optic endoilluminator probes. This system will
display the following advisory to indicate this condition: "Further increasing the output
level in air can damage fiber tips. Would you like to continue?" Avoid placing illuminated
fiber optic endoilluminator probes in contact with materials such as sterile drapes.
NOTE: Light output from an illumination source change may greatly exceed
the output from the previous source. Adjust output to lower settings after the
illumination source is changed.
8065753060 Rev. Y 2.65
REFERENCE COPY ONLY – DO NOT DISTRIBUTE
Constellation™ Vision System
Refer to the Product Lifecycle Management system for the latest revision.
SYSTEM STATE AREA
The System State area provides specific information on one of the following available
states: Setup, Surgery, or End Case. These states are selected by pressing the
associated tab in the menu bar.
Setup
System setup can be accomplished using the seven setup panels shown in Figure
2-44, the Step-by-Step Setup, or a combination of both. The Step-by-Step Setup is
explained later in this section and includes more detailed information than the Setup
panels. In both the Setup panels and Step-by-Step Setup, the user can perform the
following actions:
• View available surgical tools and consumables options.
• Connect the surgical tools and options essential for the upcoming operation.
• Prime/Test the surgical tools before commencing surgery.
Basic Setup
The basic setup uses the seven setup panels shown in Figure 2-44. These panels are
always displayed in the system state area during setup. Experienced Constellation™
Vision System users will normally use these panels to quickly setup the system.
Note: Using the barcode scanner to scan a pack automatically sets up these
panels for the accessories in that pack.
The seven panels displayed on the Setup Screen are:
• Fluidics • Accessories • Status
• Probe • Illuminators
• Handpiece • Lasers
Cannula Button:
• 20 GA Cannula
• 23 GA Cannula
• 25 GA Cannula
• 27+™ Cannula
Infusion Tubing:
This information is displayed only when the cassette is inserted and shows the
compatible infusion tubing (i.e., stopcock type: automatic or manual) for the inserted
cassette.
• Automatic Stopcock – User does not have to operate the stopcock when switching
between air and fluid.
• Manual Stopcock – User has to turn the switch on the tubing set to alternate
between air and fluid flow.
Probe Type Button - Pressing this button displays the drop down list that has the
various options for vitreous probe selection (see second screen in Figure 2-46).
Pressing one of the selections makes that probe type the active selection.
When the system detects that a probe has been connected, the probe type is
automatically selected and the “connected” icon appears next to the selection
list.
Skip Prime Option Button - Selecting this option tells the system to skip priming
the selected vitreous probe. This button is a toggle switch that displays a check mark
in the center of the button when active. When the check mark is present, the system
will not prime nor tune the vitreous probe in the next Prime/Tune request.
Probe status is displayed at the bottom of the setup panel and indicates whether the
probe has been primed and tested. A " "indicates that the priming and/or testing
have been completed, while an " " indicates that they have not.
AutoSert™ Button - The label next to this button shows the currently selected IOL
cartridge. Pressing this button causes the AutoSert™ port on the front panel to
illuminate. When the system detects that an AutoSert™ handpiece has been plugged
in, and it has finished calibrating, the “connected” icon is displayed next to this
button as shown in Figure 2-47.
Status of the AutoSert™ handpiece is shown directly below its button. If an AutoSert™
handpiece is connected, the Status indicators will indicate one of the following
conditions:
Status 1:
• If the AutoSert™ handpiece is calibrating, the display shows “Calibrating …”
• If the Plunger has been loaded, the display shows “ Plunger Loaded”
• If the Plunger has not been loaded, the display shows “ Plunger Not Loaded”
Status 2:
• If an IOL Cartridge has been loaded, the display shows “ IOL Preloaded”.
• If an IOL Cartridge has not been loaded, the display shows
“ IOL Not Preloaded”.
Note that the actions of loading the plunger and preloading the IOL can be done in
either the Setup screen or the Surgery screen by pressing the AutoSert™ button located
in the menu bar at the top of the System State Area (see Figure 2-48). Refer to the
"Surgery Modes and Submodes" section of this manual for a detailed explanation of
the AutoSert™ handpiece setup and use.
Handpieces that are marked with an asterisk (*) are automatically detected by the
system.
Tip Button - Pressing the Tip button displays the tips that the operator can choose
for the currently selected/inserted handpiece. The tip selection button is hidden if the
currently selected handpiece is “None”
Handpiece status is displayed at the bottom of the setup panel and indicates whether
the probe has been primed and/or tuned. A " "indicates that priming and/or tuning
have been completed, while an " " indicates that they have not.
Auto Gas Filling (AGF) - Pressing this button illuminates the ring on the AGF port
on the front panel. When the system detects connection of the AGF syringe assembly,
the connected icon appears next to Auto Gas Fill.
VFC (Viscous Fluid Control) - Pressing this button illuminates the ring on the VFC
port on the front panel. When the system detects connection of the VFC tubing set,
the connected icon appears next to VFC.
Forceps - When the system detects that the user has plugged in the Forceps handpiece
the connected icon appears next to the selection list. In addition, when the
operator presses this button, the system illuminates the LED on the forceps port on
the front panel.
Scissors - Pressing the button next to Scissors shows the following scissors options:
• Proportional
• Multicut
Diathermy - Pressing this button illuminates the ring on the Diathermy port on the
front panel.
Illuminator Ports - Pressing any one of the illuminator ports allows the user to select
between a straight, wide angled, or chandelier endoilluminator probe. In addition,
when the user makes a selection from the drop list, the system illuminates the ring on
the associated illuminator port on the front panel. When the system detects connection
of an endoilluminator probe on a port, the “connected” icon appears next to that port
on the selection list and the operator will not be able to select another probe type from
the touchscreen for that port (the selection list will be locked).
The Status panel also displays the Patient Eye Level (PEL) including units (inches or
cm).
More Information Button - Pressing the More Information button opens the
popup shown in Figure 2-52 that provides additional details on Inlet Pressure and
PEL.
When the Inlet Pressure tab is selected, the actual value in psi is displayed in the
appropriate segment of the status bar.
When the Patient Eye Level tab is selected, the Patient Eye Level offset and units
can be specified. A graphic that depicts the distance from the cassette connectors to
the patient’s eye level is also displayed.
Instructions
Stage
Selection
Graphical
Guide
Contextual
Help
Setup begins with the General stage of the process. The user should complete each
step in the Instructions section while refering to the associated graphics in the
Graphical Guide. When all steps in the stage are complete, pressing the next Stage
Selection button in the sequence will advance to the next setup stage.
Pressing the Help button at the bottom of the screen displays a reference diagram that
defines each section of the Step-by-Step Setup screen.
Instructions - The Instructions section contains detailed instructions for the current
stage. Numbered steps refer the user to a corresponding area in the Graphical Guide
with the same number. The instructions displayed will vary depending upon the stage
selected and the state of the system in that stage.
Graphical Guide - This section contains graphics to guide the user in instrument
selection and connection. The graphics displayed will vary depending on which stage
is selected and on the state of the system in that stage.
An example of how the state of the system affects the content of the instructions and
graphics is shown in Figure 2-54. The Vit Probe stage is shown but with the system
in different states. The screen on the left shows a system with no vit probe connected.
In this case, instructions are provided to connect a vit probe along with the ability in
the graphics section to select a specific vit probe. Notice that the Connection Guide
displays yellow arrows to show exactly where to connect the probe.
The screen on the right shows a system with a vit probe already connected and
recognized. In this case, the instructions and graphics show only those steps necessary
to complete the setup for the Vit Probe stage.
VIT PROBE NOT CONNECTED VIT PROBE CONNECTED
Figure 2-56 shows the LED Color Guide. This guide explains the meaning of the
colors of the ring illuminators on the console. The guide is available in the following
stages:
• Vit Probe
• Handpiece
• Illuminators
• Accessories
Stop Button
Figure 2-57 Prime & Test Status Bar Variations
• Push Prime - Push prime is the system default when a new cassette is inserted
into the system at the beginning of a surgical case. During push prime, irrigation
solution is "pushed" through both the irrigation and aspiration lines. When push
prime is active, the Start Prime button appears with no icon as shown at left.
• Suction Prime - Suction prime is used in the event an accessory must be
re-primed after the surgical case has started. In this situation, the handpiece
must be inserted into a container of sterile solution, and priming is accomplished
through suction (aspiration) pulling the solution from the container. When suction
prime is active, the Start Prime button appears with an icon as shown at left.
The operator can choose to view all consumables or filter the list as desired by
pressing the associated button on the Display Filter list.
To add an item: Select the item from the consumables list in the bottom of the popup
then press the Add button. The selection will be added to the top list as an item used
for the current case.
To remove an item: Select the item from the list in the top of the popup then press the
Remove button. The selection will be removed from the top list.
Custom Consumables
Pressing the Custom Display Filter shows a list of Consumables that were added by
the user when scanning a barcode not currently known to the system. The Manage
button, available only in the Custom Display Filter, launches a detailed view of the
Custom Consumables where each item can be Edited or Removed from the system
(see Figure 2-58).
NOTE: Refer to the Directions For Use (DFU) included with each accessory kit/
consumable pack for detailed instructions on how to setup that accessory.
The Surgery Screen shown in Figure 2-59 is organized in the following way:
• Menu Bar - The menu bar is context aware and changes the options depending
on the surgical mode. Buttons that appear here allow the user to make selections
for items such as Cataract Grade, handpiece testing and tip selection, AutoSert™
Setup, and Auto Gas Fill control.
• Surgery Panels - Each Surgery Panel corresponds to a “Surgical Function” and
contains the various controls necessary to control each function.
• Step Panel - The Step Panel allows the user to select Surgical Modes and
Submodes by pressing a Step Button and a Submode Button. The look of the Step
Panel depends on which Surgical Procedure (discussed later) is selected.
Menu
Bar
Timer Tab
Surgical Controls
Surgery
Panels
Submode Button(s)
Step Button(s)
Step
Panel
Start Value
End Value
On/Off Button
Decrease Setpoint
More Information Button
Value Button(s)
Actual Value
Slider Controls
• On/Off Button– Toggles the function on and off. A green button indicates that the
function is on while a dark gray button indicates that the function is off.
• Up/Down Arrow Buttons – Increase/decreases the associated setpoint value. The
button face indicates whether or not the associated setpoint can be increased or
decreased. The button is disabled when increases/decreases are not allowed.
• Start Value – Shows the current setpoint at the treadle starting position.
• End Value - Shows the setpoint at full treadle.
• On/Off button - Toggles the option On and Off. This control is disabled when the
functionality is not available.
• Left Option button - Allows the user to initiate the function assigned to this button
("Start" in Figure 2-62).
• Right Option button - Allows the user to initiate the function assigned to this
button ("Close" in Figure 2-62).
• Save Calibration Values - Pushing this button saves calibration values.
Figure 2-63 Surgical Control with Dropdown List (Advanced Display Mode)
The Accurus™ Classic procedure contains one step for each surgery mode. However,
at any point in time only a subset or a “View” of the steps is displayed. The Views
differ depending on:
• The Fluidics Operating Mode (Combined, Anterior, or Posterior)
• The connected U/S handpiece (defaults to Phaco if no U/S handpiece is
connected)
The screen shown in Figure 2-64 shows the Accurus™ Classic procedure in combined
mode.
Figure 2-64 Accurus™ Classic Surgery Screen (Advanced Display Mode shown
Custom Procedures are intended to contain all the steps that the user has included to
perform a certain task. However, in some cases the user may need to do something
that is not included in the current procedure. In addition to the manual method of
adding surgical steps through the Modify Procedure screen as described previously in
this section, the system automatically adds relevant step(s) when an instrument (such
as a vitreous probe) is connected. For example if the user suddenly requires the use of
the laser, the system automatically adds a laser step to the end of the procedure when
it detects the connection of a laser probe. Also, if a laser probe is already connected
when the procedure is selected, a laser step is added to the end of the procedure.
Selected Step
The Step buttons act as radio buttons in that only one step at a time can be selected
and a step must always be selected at any point in time.
Scroll Bar
Proportional
3D Momentary WetAnt VitDry Forceps
Vitrectomy (Vit) Vacuum
(Post, Comb)† (Post, Comb)† (Ant, Comb)† (Ant)† (Post, Comb)†
(Post, Comb)†
3D Burst Pulsed Continuous Custom††
Phaco
(Ant, Comb)† (Ant, Comb)† (Ant, Comb)† (Ant, Comb)† (Ant, Comb)†
3D Fixed Linear Momentary
Fragmentation (Frag)
(Post, Comb)† (Post, Comb)† (Post, Comb)† (Post, Comb)†
Irrigation/Aspiration (I/A)
(Ant, Comb) †
Extrusion
(Post, Comb)†
Laser
(Post, Comb)†
Multicut Proportional Forceps
Scissors
(Post, Comb)† (Post, Comb)† (Post, Comb)†
Forceps
(Post, Comb)†
Vacuum (Inject
Viscous Fluid Control Extract Inject
only)
(VFC) (Post, Comb)† (Post, Comb)†
(Post, Comb)†
AutoSert™
(Ant, Comb)†
† Indicates the type of cassette that must installed to enable the specified mode. Ant = Anterior Cassette; Post = Posterior Cassette;
Comb = Combined Cassette.
†† Available in the Advanced View only.
Each surgical mode has a set of associated surgical panels. The following settings
affect how some panels are displayed:
• Standard vs. Advanced display mode - The standard display mode offers a
minimum number of options in the associated panel. In advanced display mode,
the displayed panels offer optional controls for setting and configuring functions.
The default mode is Standard. Advanced display mode is available in the
following panels: Extraction, Vit Cutting, Ultrasound, and Vitrectomy Bimanual.
Selecting Standard or Advanced mode is done in the Options\ Doctor Settings\
General screen (see Figure 2-67).
• Vacuum mode vs. Flow mode - By default, the posterior modes show the vacuum
panel for vacuum mode, and the anterior modes show the aspiration panel for
flow mode (if available). In Advanced display mode, the Function mode panel
allows the user to select between Flow and Vacuum modes. Changing modes will
change the panel accordingly.
• Bimanual mode - Vit, scissors, and VFC modes offer the surgeon the option of
controlling two instruments simultaneously such as a vitreous probe and a pair
of forceps (in Vit mode). This is referred to as Bimanual mode and the additional
instrument is activated by pressing the Bimanual button.
Figure 2-67 Standard versus Advanced Display Modes: The Standard mode provides the basic
controls necessary in each surgical step; the Advanced mode offers additional controls that enable
the user to utilize all the capabilities of the Constellation™ Vision System.
Vitrectomy: 3D SUBMODE
In the 3D submode shown in Figure 2-68, the user controls both the vitreous cut rate
and the vacuum pressure linearly. This submode allows for setting the treadle start
and end values for both the cut rate and the vacuum pressure.
In 3D submode, vacuum delivered to the probe and the probe cutting rate are both
regulated by the amount of footpedal depression. The display contains adjustable
values for vacuum level at footpedal start and at full depression; and cut rate at
footpedal start and at full depression. The unique features of this mode are:
• Vacuum can be set to start at 0 and rise to its maximum setting at full footpedal
depression, while the cutting rate can be set to start at its maximum setting and
decrease as the footpedal is depressed (or any combination thereof).
• To prevent generating excessive flow when the footpedal is first depressed, the
vacuum level is ramped up from 0 to the set starting level during the first part of
the pedal travel.
• When the Start Limit is greater than 0, the vacuum uses the Ramping % selected
in the Doctor's Settings to ramp from 0 to the Start Limit.
The controls for each panel in 3D submode have the following functions:
Vacuum Panel:
• On/Off - Turns vacuum on or off.
• Vacuum Start Up/Down Buttons - Set the vacuum level at treadle start.
• Vacuum End Up/Down Buttons - Set the vacuum level at full treadle.
• Vacuum More Information Button - Displays the More Information popup
allowing the user to make changes using slider controls. Also provides panel
specific configuration capabilities (such as drainbag change).
The following Vacuum panel controls are available only in the Advanced view:
• Flow Limit On/Off Button - Turns flow limit on or off. When the
maximum rate is reached the vacuum level can no longer be increased. If
the Flow Limit is turned off, the vacuum level is limited only by the Start
and End values.
• Flow Limit Start and End Up/Down Buttons - Set the start and end limits
for the flow rate.
• Flow Limit More Information Button - Displays the Flow Limit More
Information popup.
• Flow/Vacuum Toggle - Switches between Flow Mode and Vacuum Mode.
• Flow Limit Control Type Drop List - Determines whether the flow limit is
fixed or linear. In Fixed, the limit is constant regardless of the flow level.
In Linear, the limit varies depending on the flow level.
• Reflux Label - Read Only display of the current reflux configuration
together with its current value.
• Reflux More Information Button - Displays the More Information popup
that allows for changing the current mode and the setpoint associated with it.
2.90 8065753060 Rev. Y
REFERENCE COPY ONLY – DO NOT DISTRIBUTE
Constellation™ Vision System
Refer to the Product Lifecycle Management system for the latest revision.
Cutting Panel:
• Cut Rate On/Off Button - Turns the cutter on or off.
• Cut Rate Start Up/Down Buttons - Set the cut rate at treadle start.
• Cut Rate End Up/Down Buttons - Set the cut rate at full treadle.
• Cutting More Information Button - Displays the More Information popup.
• Cutting Table Drop List (Advanced view only) - Allows selection of port open
duty cycle that is appropriate for the procedure to be performed.
Core† - Provides the maximum port open duty cycle control suited for core
vitrectomy where higher flow rates and efficiency are desirable.
50/50† - Provides a 50% port open duty cycle control for those users who
prefer that the cutter is open and closed for the same amount of time.
Shave† - Provides the minimum port open duty cycle suited for removing
delicate tissue (such as vitreous shaving and membrane dissection) where
lower flow rates are desirable.
† For HyperVit™ probes the Core, 50/50 and Shave modes have similar BSS™ flow rates.
Aspiration Panel
More Information Button
Flow/Vacuum Toggle
Vacuum Panel
g
Rampin Vac Start Limit
Cut Rate
1 End Limit
Increasing Treadle Depression
ate
(Bi Manual Off) Cut R Vac End Limit
asing
Incre
u m
Vacu
Cut Rate asing
Incre
Start Limit
g
Rampin Vac Start Limit
1
Increasing Treadle Depression
Figure 2-68 Surgery Screen: Vitrectomy Mode - 3D Submode (Advanced View shown)
Aspiration Panel
More Information Button
Flow/Vacuum Toggle
Vacuum Panel
Vac End
Cut Rate when Limit
BI MANUAL ON Momentary switch
(forceps active in activated
footswitch position 1) uu
m
c
Va
Figure 2-69 Surgery Screen: Vitrectomy Mode-Momentary Submode (Advanced View shown)
Vacuum Panel:
• On/Off - Turns vacuum on or off.
• Vacuum End Up/Down Buttons - Set the vacuum level at full treadle.
• Vacuum More Information Button - Displays the More Information popup,
allowing the user to make changes using slider controls. Also provides panel
specific configuration capabilities (such as drainbag change).
The following Vacuum panel controls are available only in the Advanced view:
• Flow Limit On/Off Button - Turns flow limit on or off. When the
maximum rate is reached the vacuum level can no longer be increased. If
the Flow Limit is turned off, the vacuum level is limited only by the End
value.
• Flow Limit Start and End Up/Down Buttons - Set the start and end limits
for the flow rate.
• Flow Limit More Information Button - Displays the Flow Limit More
Information popup.
• Flow/Vacuum Toggle - Switches between Flow Mode and Vacuum Mode.
• Flow Limit Control Type Drop List - Determines whether the flow limit is
fixed or linear. In Fixed, the limit is constant regardless of the flow level.
In Linear, the limit varies depending on the flow level.
• Reflux Label - Read Only display of the current reflux configuration
together with its current value.
• Reflux More Information Button - Displays the More Information popup
that allows for changing the current mode and the setpoint associated with
it.
Cutting Panel:
• Cut Rate End Up/Down Buttons - Set the cut rate at full treadle.
• Cutting More Information Button - Displays the More Information popup.
• Cutting Table Drop List (Advanced view only) - Allows selection of port open
duty cycle that is appropriate for the procedure to be performed.
Core† - Provides the maximum port open duty cycle control suited for core
vitrectomy where higher flow rates and efficiency are desirable.
50/50† - Provides a 50% port open duty cycle control for those users who
prefer that the cutter is open and closed for the same amount of time.
Shave† - Provides the minimum port open duty cycle suited for removing
delicate tissue (such as vitreous shaving and membrane dissection) where
lower flow rates are desirable.
† For HyperVit™ probes the Core, 50/50 and Shave modes have similar BSS™ flow rates.
Aspiration Panel
More Information Button
Flow/Vacuum Toggle
Vacuum Panel
Cut Rate
Cut Rate Set Limit
Figure 2-70 Surgery Screen: Vitrectomy Mode-PropVac Submode (Advanced View shown)
Vacuum Panel:
• On/Off - Turns vacuum on or off.
• Vacuum End Up/Down Buttons - Set the vacuum level at full treadle.
• Vacuum More Information Button - Displays the More Information popup
allowing the user to make changes using slider controls. Also provides panel
specific configuration capabilities (such as drainbag change).
The following Vacuum panel controls are available only in the Advanced view:
• Flow Limit On/Off Button - Turns flow limit on or off. When the
maximum rate is reached, the vacuum level can no longer be increased. If
the Flow Limit is turned off, the vacuum level is limited only by the End
value.
• Flow Limit Start and End Up/Down Buttons - Set the start and end limits
for the flow rate.
• Flow Limit Configuration Button - Displays the Flow Limit configuration
popup.
• Flow/Vacuum Toggle - Switches between Flow Mode and Vacuum Mode.
• Flow Limit Control Type Drop List - Determines whether the flow limit is
fixed or linear. In Fixed, the limit is constant regardless of the flow level.
In Linear, the limit varies depending on the flow level.
• Reflux Label - Read Only display of the current reflux configuration
together with its current value.
• Reflux More Information Button - Displays the More Information popup
that allows for changing the current mode and the setpoint associated with
it.
Cutting Panel:
• Cut Rate On/Off Button - Turns the cutter on or off.
• Cut Rate End Up/Down Buttons - Set the fixed cut rate throughout treadle
depression.
• Cutting More Information Button - Displays the More Information popup.
Aspiration Panel
More Information Button
Flow/Vacuum Toggle
Vacuum Panel
uum
Vac
asing
Vacuum Start Limit Incre
1 2
Treadle Released Detent Full Treadle
Depression
Figure 2-71 Surgery Screen: Vitrectomy Mode-WetAnt Submode (Advanced View shown)
The following Vacuum panel controls are available only in the Advanced view:
• Flow Limit On/Off Button - Turns flow limit on or off. When the
maximum rate is reached the vacuum level can no longer be increased. If
the Flow Limit is turned off, the vacuum level is limited only by the End
value.
• Flow Limit Start and End Up/Down Buttons - Set the start and end limits
for flow rate.
• Flow Limit More Information Button - Displays the Flow Limit More
Information popup.
• Flow/Vacuum Toggle - Switches between Flow mode and Vacuum mode.
• Flow Limit Control Type Drop List - Determines whether the flow limit is
fixed or linear. In Fixed, the limit is constant regardless of the flow level.
In Linear, the limit varies depending on the flow level.
• Reflux Label - Read Only display of the current reflux configuration
together with its current value.
• Reflux More Information Button - Displays the More Information popup
that allows for changing the current mode and the setpoint associated with
it.
Cutting Panel:
• Cut Rate On/Off Button - Turns the cutter on or off.
• Cut Rate End Up/Down Buttons - Set the cut rate at full treadle.
• Cutting More Information Button - Displays the More Information popup.
The Cut Rate is adjusted by pressing Up/Down arrow buttons on the Cutting control.
Alternatively, selecting the More Information button on the Cutting control displays
the More Information popup that has a slidebar for large numeric adjustments in cut
rate.
The controls for each panel in VitDry submode are the same as in 3D submode with
the following exceptions:
• No Vacuum On/Off Button.
• No Cut Rate Start Up/Down Buttons - Cut rate is a constant rate set by the End
buttons and activated when the footpedal is pressed.
• No Forceps Panel.
• No Vacuum (or Flow) Start Up/Down Buttons.
Aspiration Panel
Flow/Vacuum Toggle
Vacuum Panel
Cut Rate
Cut Rate Set Limit
uum
Vac
sing
Vacuum Start Limit rea
Inc
1
Treadle Released Full Treadle
Depression
Figure 2-72 Surgery Screen: Vitrectomy Mode-VitDry Submode (Advanced View shown)
The following Vacuum panel controls are available only in the Advanced view:
• Flow Limit On/Off Button - Turns flow limit on or off. When the
maximum rate is reached the vacuum level can no longer be increased. If
the Flow Limit is turned off, the vacuum level is limited only by the End
value.
• Flow Limit Start and End Up/Down Buttons - Set the start and end limits
for flow rate.
• Flow Limit More Information Button - Displays the Flow Limit More
Information popup.
• Flow/Vacuum Toggle - Switches between Flow mode and Vacuum mode.
• Flow Limit Control Type Drop List - Determines whether the flow limit is
fixed or linear. In Fixed, the limit is constant regardless of the flow level.
In Linear, the limit varies depending on the flow level.
• Reflux Label - Read Only display of the current reflux configuration
together with its current value.
• Reflux More Information Button - Displays the More Information popup
that allows for changing the current mode and the setpoint associated with it.
Cutting Panel:
• Cut Rate On/Off Button - Turns the cutter on or off.
• Cut Rate End Up/Down Buttons - Set the cut rate at full treadle.
• Cutting More Information Button - Displays the More Information popup.
WARNING!
Good clinical practice dictates testing for adequate irrigation, aspiration flow,
reflux, and operation as applicable for each handpiece prior to entering eye.
The five submodes available in Phaco mode are listed below. In each submode, the
Aspiration and Vacuum panels are identical while the Ultrasound panels change
according to the requirements of the current mode.
• 3D
• Burst
• Custom (Advanced View only)
• Pulsed
• Continuous
Dynamic Rise
The value in the display bar indicates the current rise time for the aspiration pump
rate adjustment at occlusion onset. The Dynamic Rise setting can vary from –2 to 4,
in increments of 1. When Dynamic Rise -2 is displayed in the Adjust Bar, it indicates
that the rise time in aspiration pump rate adjustment is slowest. When Dynamic Rise
4 is displayed in the Adjust Bar, it indicates that the rise time in aspiration pump rate
adjustment is fastest. The Alcon default setting is 0. Dynamic rise is only available in
Flow Mode.
WARNING!
The use of Dynamic Rise setting 1, 2, 3, or 4 may result in aspiration levels (volumes)
exceeding irrigation flow. This may cause chamber shallowing or collapse which
may result in patient injury.
When the algorithm is active, ultrasound power will be generated at 10% or half
of the commanded power, whichever is lower, prior to the application of the main
power pulse. This low-powered pulse contributes a negligible amount of energy to the
procedure, but it allows the electronic equipment to determine the optimum operating
parameters for the main power pulse, thus making it more efficient, even for the
shortest duration of ultrasound. The Smart Pulse algorithm can be active in Custom,
Pulsed, or Burst modes when used with the OZil™ torsional or U/S handpieces. The
minimum duration of the main pulse in ultrasound is 5 ms; the minimum duration of
torsional pulse is 20 ms.
nic
as o
ltr cillation
U
Os
co
Pha
OZil™ Timing
Phaco power and ultrasonic oscillations are delivered to the phaco tip through a
variety of timing configurations when in footpedal position 3 (position 2 for 3D
mode). Depending on the mode selected, the timing can be continuous or can include
off-times between phaco/torsional pulses.
OZil™ IP
Intelligent Phaco (IP) is used to deliver a reduced magnitude of phaco energy when
a vacuum threshold setting is exceeded. This reduced phaco energy is applied only
as necessary, and continues until the vacuum drops below the trigger threshold. The
same IP settings are used for each enabled phaco step. IP is not available in the 3D
submode and is only available in Flow Mode when the Advanced Extraction
Display Mode is selected in the Doctor Settings.
Pressing the IP button while in a phaco step causes the IP Settings dialog to appear on
the screen (see Figure 2-75). Intelligent Phaco is enabled by pressing the On button,
or disabled by pressing the Off button. After selecting On or Off and pressing the
Close button, the dialog closes. When the IP feature is enabled for a particular phaco
step, the IP button is colored green; when disabled, it is colored gray. When IP is
active during a procedure, the IP button is animated.
The 3D submode screen is shown in Figure 2-76 along with a graphic representation
of the functions in each footswitch treadle position. Note that the start and end limits
for both U/S Power and vacuum are adjustable therefore any combination of limits is
valid. The graphic shows only one possibility.
Aspiration Panel
More Information Button
Flow/Vacuum Toggle
Vacuum Panel
U/S P
Irrigation ON ower
u um
Vac U/S Power End Limit
ping
Ram
1 2
Treadle Detent Full Depression
Released
Increasing Treadle Depression
Figure 2-76 Surgery Screen: Phaco Mode - 3D Submode (Advanced View shown)
o
OZil ™ ™ Phac
Torsio
nal OZil
Irrigation ON
uum
Vac U/S Power End Limit
ping
Ram
1 2
Treadle Detent Full Depression
Released
Increasing Treadle Depression
The controls for each panel in Burst submode (see Figure 2-78) have the following
functions:
Vacuum Panel:
• Vacuum End Up/Down Buttons - Set the vacuum level at the end of position 2.
• Vacuum Start Up/Down Buttons - Set the vacuum level at the start of treadle
position 2.
• Vacuum More Information Button - Displays the More Information popup, which
simplifies large value changes by providing slider controls. Also provides the
capability to initiate a drainbag change.
Aspiration Panel
More Information Button
Flow/Vacuum Toggle
Reflux Label
Irrigation ON
U/S Burst at
m
uu set limit
ac
in gV
as
re
Inc
1 2 3
Treadle Detent 1 Detent 2 Full Depression
Released
Increasing Treadle Depression
Figure 2-78 Surgery Screen: Phaco Mode - Burst Submode (Advanced View shown)
Aspiration Panel (This control is available only in the Advanced view by switching
the Function Mode from Vacuum to Flow):
• Flow Start Up/Down Buttons - When linear, set Flow at treadle start of position 2.
• Flow End Up/Down Buttons - Set the flow level at end of position 2.
• Dynamic Rise Drop List - Selection for the rise value. The rise value determines
the automatic adjustment of the flow set point when occlusion onset is reached.
• Flow More Information Button - Displays the More Information popup which
simplifies large value changes by providing slider controls. Also provides the
capability to initiate a drainbag change.
• Vacuum Limit Start and End Up/Down Buttons - Set the start and end limits for
vacuum.
• Vacuum Limit Control Type Drop List - Determines whether the vacuum limit is
fixed or linear. In Fixed the limit is constant regardless of the vacuum level. In
Linear the limit varies depending on the vacuum level.
• Vacuum Limit More Information Button - Displays the More Information popup.
• Flow/Vacuum Toggle: Switches between Flow mode and Vacuum mode.
• Reflux Label - Read Only display of the current reflux configuration together with
its current value.
• Reflux More Information Button - Displays the Reflux More Information popup.
Ultrasound Panel:
• Power Start Up/Down Buttons - When Linear, set power at start of position 3.
• Power End Up/Down Buttons - Set the power at full treadle.
• Power Progress Bar and Numerical Value - Displays the current power value.
• Power Limit Control Type Drop List (Advanced view only) - Determines whether
the power is fixed or linear. In Fixed, the power is constant. In Linear, the power
varies depending on the treadle position.
• Phaco Power More Information Button - Displays the More Information popup,
which simplifies large value changes by providing slider controls.
• Phaco Burst On Time Up/Down Buttons - Set the Phaco Burst On time.
• Phaco Burst Off Time Up/Down Buttons - Set the Phaco Burst Off time.
• Phaco Burst Off Time Progress Bar and Numeric Value - Shows the current Phaco
Burst Off time.
• Phaco Burst More Information Button - Displays the More Information popup.
If Phaco Power Limit and/or Torsional Amplitude Limit are set to zero, then there are
no phaco or torsional contributions to the OZil™ burst, and the duty cycles (On ms)
are not adjustable.
Torsional Amplitude Panel:
• Torsional Amplitude Start Up/Down Buttons - Sets the torsional amplitude level
at treadle start of position 3.
• Torsional Amplitude End Up/Down Buttons - Sets the torsional amplitude at full
treadle.
• Torsional Amplitude Progress Bar and Numerical Value - Shows the current
torsional amplitude value.
• Torsional Amplitude Limit Control Type Drop-Down List - Determines whether
the torsional amplitude is Fixed or Linear.
• Torsional Amplitude More Information Button - Displays the More Information
popup.
• Torsional On Time Control (in Burst panel) - Sets the Torsional Burst On Time.
Irrigation ON
er OZil™ Burst
um Pow
u aco
ac s in g Ph tu d e
in gV Incre
a
al Am
pli
as T o rsion
re &
Inc
1 2 3
Treadle Detent 1 Detent 2 Full Depression
Released
Increasing Treadle Depression
Figure 2-79 Surgery Screen: Phaco Mode - Burst Submode - OZil™ Burst
Aspiration Panel
More Information Button
Flow/Vacuum Toggle
Reflux Label
1 2 3
Treadle Detent 1 Detent 2 Full Depression
Released
Increasing Treadle Depression
Figure 2-80 Surgery Screen: Phaco Mode - Custom Submode (Advanced view shown)
Aspiration Panel (This control is available only in the Advanced view by switching
the Function Mode from Vacuum to Flow):
• Flow Start Up/Down Buttons - When linear, set the flow level at start of position 2.
• Flow End Up/Down Buttons - Set the flow level at the end of position 2.
• Dynamic Rise Drop List - Select for the rise value. The rise value determines the
automatic adjustment of the flow set point when occlusion onset is reached.
• Flow More Information Button - Displays the More Information popup which
simplifies large value changes by providing slider controls. Also provides the
capability to initiate a drainbag change.
• Vacuum Limit Start and End Up/Down Buttons - Set the start and end limits for
vacuum.
• Vacuum Limit Control Type Drop List - Determines whether the vacuum limit is
fixed or linear. In Fixed the limit is constant regardless of the vacuum level. In
Linear the limit varies depending on the vacuum level.
• Vacuum Limit More Information Button - Displays the More Information popup.
• Flow/Vacuum Toggle: Switch between Flow mode and Vacuum mode.
• Reflux Label - Read Only display of the current reflux configuration together with
its current value.
• Reflux More Information Button - Displays the Reflux More Information popup.
Ultrasound Panel:
• Phaco Power Start Up/Down Buttons - When linear, set power at start of position 3.
• Phaco Power End Up/Down Buttons - Set the power at full treadle.
• Phaco Power Progress Bar and Numerical Value - Show the current power value.
• Phaco Power Limit Control Drop Down List - Determines whether the power
is fixed or linear. In Fixed the power is constant regardless. In Linear the power
varies depending on the treadle position.
• Phaco Power More Information Button - Displays the More Information popup,
which simplifies large value changes by providing slider controls.
• Phaco Pulse On Time Up/Down Buttons - Set the Phaco pulse on time.
• Phaco Pulse On Time Progress Bar and Numeric Value - Show the current Phaco
pulse on time.
Irrigation ON
OZil™ Torsional Amplitude
uum
ac
in gV
as
re
Inc
1 2 3
Treadle Detent 1 Detent 2 Full Depression
Released
Increasing Treadle Depression
Figure 2-81 Surgery Screen: Phaco Mode - Custom Submode - OZil™ Custom Pulse (Advanced view
shown)
Aspiration Panel
More Information Button
Flow/Vacuum Toggle
Reflux Label
uum
ac
in gV ear)
as r (lin
re owe
Irrigation ON Inc oP
Phac
1 2 3
Treadle Detent 1 Detent 2 Full Depression
Released
Increasing Treadle Depression
Figure 2-82 Surgery Screen: Phaco Mode - Pulsed Submode (advanced view shown)
Irrigation ON
OZil™ Torsional Amplitude
uum
ac
in gV
as
re
Inc
Figure 2-83 Surgery Screen: Phaco Mode - Pulsed Submode OZil™ Pulse
The controls for each panel in Continuous submode shown in Figure 2-84 have the
following functions:
Vacuum Panel:
• Vacuum End Up/Down Buttons - Sets the vacuum level at full treadle.
• Vacuum More Information Button - Displays the More Information popup, which
simplifies large value changes by providing slider controls. Also provides the
capability to initiate a drainbag change.
Aspiration Panel
Flow/Vacuum Toggle
Reflux Label
1 2 3
Treadle Detent 1 Detent 2 Full Depression
Released
Increasing Treadle Depression
Figure 2-84 Surgery Screen: Phaco Mode - Continuous Submode (Advanced view shown)
Aspiration Panel (This control is available only in the Advanced view by switching
the Function Mode from Vacuum to Flow):
• Flow Start Up/Down Buttons - When linear, set the flow level at treadle start of
position 2.
• Flow End Up/Down Buttons - Set the flow level at end of treadle position 2.
• Dynamic Rise Drop List - Selects the rise value. The rise value determines the
automatic adjustment of the flow set point when occlusion onset is reached.
• Flow More Information Button - Displays the More Information popup which
simplifies large value changes by providing slider controls. Also provides the
capability to initiate a drainbag change.
• Vacuum Limit Start and End Up/Down Buttons - Set the start and end limits for
vacuum.
• Vacuum Limit Control Type Drop List - Determines whether the vacuum limit is
fixed or linear. In Fixed the limit is constant regardless of the vacuum level. In
Linear the limit varies depending on the vacuum level.
• Vacuum Limit More Information Button - Displays the More Information popup.
• Flow/Vacuum Toggle: Switches between Flow mode and Vacuum mode.
• Reflux Label - Read Only display of the current reflux configuration together with
its current value.
• Reflux More Information Button - Displays the Reflux More Information popup.
Ultrasound Panel:
• Phaco Power Start Up/Down Buttons - When linear, set power at treadle start of
position 3.
• Phaco Power End Up/Down Buttons - Set the power at full treadle.
• Phaco Power Progress Bar and Numerical Value - Shows the current power value.
• Ultrasound More Information Button - Displays the More Information popup.
The following Ultrasound panel controls are available only in the Advanced view:
• Power Limit Control Type Drop List - Determines whether the power
limit is fixed or linear. In Fixed, the limit is constant regardless of the
footswitch treadle position. In Linear, the limit varies depending on the
footswitch treadle position.
The user can select between fixed or linear for both Phaco Power and Torsional
Amplitude from the Control Type drop down list on each control.
Torsional Amplitude Panel:
• Torsional Amplitude Start Up/Down Buttons - Sets the torsional amplitude level
at treadle start of position 3.
• Torsional Amplitude End Up/Down Buttons - Sets the torsional amplitude at full
treadle.
• Torsional Amplitude Progress Bar and Numerical Value - Shows the current
torsional amplitude value.
• Torsional Amplitude Limit Control Type Drop-Down List - Determines whether
the torsional amplitude is Fixed or Linear.
• Torsional Amplitude More Information Button - Displays the More Information
popup.
Irrigation ON
OZil™ Torsional Amplitude
uum
ac
in gV
as
re
Inc
Figure 2-85 Surgery Screen: Phaco Mode - Continuous Submode - OZil™ Continuous
To prevent generating excessive flow when the footpedal is first depressed, the
vacuum level is ramped up from zero to the set starting level during the first part of
the pedal travel. The Ramping % is selected in the Doctor's Settings screen with an
available range of 15-90%.
The 3D submode screen is shown in Figure 2-86 along with a graphic representation
of the functions in each footswitch treadle position. Note that the start and end limits
for both U/S Power and vacuum are adjustable therefore any combination of limits is
valid. The graphic shows only one possibility.
The controls for each panel in 3D submode have the following functions:
Vacuum Panel:
• Vacuum Start Up/Down Buttons - Set the vacuum level at treadle start.
• Vacuum End Up/Down Buttons - Set the vacuum level at full treadle.
• Vacuum More Information Button - Displays the More Information popup, which
simplifies large value changes by providing slider controls. Also provides the
capability to initiate a drainbag change.
The following vacuum controls are available only in the Advanced View:
• Flow Limit On/Off Button - Turns Flow Limit on or off. When the maximum
rate is reached, the vacuum level can no longer be increased. If the Flow Limit is
turned off, the vacuum level is limited only by the Start and End values.
• Flow Limit Start and End Up/Down Buttons - Set the start and end limits for flow
rate.
• Flow Limit Progress Bar and Numerical Value - Show the current flow level.
• Flow Limit More Information Button - Displays the More Information popup.
• Flow Limit Control Type Drop List - Determines whether the flow limit is fixed
or linear. In Fixed the limit is constant regardless of the flow level. In Linear the
limit varies depending on the flow level.
• Flow/Vacuum Toggle - Switches between Flow Mode and Vacuum Mode.
• Reflux Label - Read Only display of the current reflux configuration together with
its current value.
• Reflux More Information Button - Displays the Reflux More Information popup.
Aspiration Panel
Flow/Vacuum Toggle
Vacuum Panel
u um
Vac U/S Power End Limit
ing
Ramp
Figure 2-86 Surgery Screen: Fragmentation Mode - 3D Submode (Advanced view shown)
Aspiration Panel (This control is available only in the Advanced view by switching
the Function Mode from Vacuum to Flow):
• Flow Start Up/Down Buttons - Set the flow level at treadle start.
• Flow End Up/Down Buttons - Set the flow level at full treadle.
• Flow More Information Button - Displays the More Information popup which
simplifies large value changes by providing slider controls. Also provides the
capability to initiate a drainbag change.
• Vacuum Limit Start and End Up/Down Buttons - Set the start and end limits for
vacuum.
• Vacuum Limit Control Type Drop List - Determines whether the vacuum limit is
fixed or linear. In Fixed the limit is constant regardless of the vacuum level. In
Linear the limit varies depending upon treadle depression.
• Vacuum Limit More Information Button - Displays the More Information popup.
• Flow/Vacuum Toggle: Switches between Flow mode and Vacuum mode.
• Reflux Label - Read Only display of the current reflux configuration together with
its current value.
• Reflux More Information Button - Displays the Reflux More Information popup.
2.124 8065753060 Rev. Y
REFERENCE COPY ONLY – DO NOT DISTRIBUTE
Constellation™ Vision System
Refer to the Product Lifecycle Management system for the latest revision.
Ultrasound Panel:
• Phaco Power Start Up/Down Buttons - Set the power level at treadle start.
• Phaco Power End Up/Down Buttons - Set the power at full treadle.
• Phaco Power Progress Bar and Numerical Value - Show the current power value.
• Ultrasound More Information Button - Displays the More Information popup.
• Pulse Rate On/Off Button - Turns the Pulse Rate on or off.
• Pulse Rate Up/Down Buttons - Set the pulse rate.
• Pulse More Information Button - Displays the More Information popup.
The following Vacuum controls are available only in the Advanced view:
• Flow Limit On/Off Button - Turns Flow Limit on or off. When the
maximum rate is reached, the vacuum level can no longer be increased. If
the Flow Limit is turned off, the vacuum level is limited only by the End
value.
• Flow Limit Start and End Up/Down Buttons - Set the start and end limits
for flow rate.
• Flow Limit Control Type Drop List - Determines whether the flow limit is
fixed or linear. In Fixed, the limit is constant regardless of the flow level.
In Linear, the limit varies depending on the flow level.
• Flow Limit Progress Bar and Numerical Value - Displays the current flow rate.
• Flow/Vacuum Toggle - Switches between Flow Mode and Vacuum Mode.
• Flow Limit More Information Button - Displays the More Information popup.
• Reflux Label - Read Only display of the current reflux configuration
together with its current value.
• Reflux More Information Button - Displays the Reflux More Information
popup.
Aspiration Panel (This panel is available only in the Advanced View when the Flow
button is selected.)
• Flow End Up/Down Buttons - Set the flow level at full treadle.
• Flow Progress Bar and Numerical Value - Display the current flow level.
• Aspiration More Information Button - Displays the More Information popup.
• Vacuum Limit Start and End Up/Down Buttons - Set the start and end limits for
vacuum.
Ultrasound Panel:
• Power On/Off Button - Turns ultrasound power on or off.
• Power End Up/Down Buttons - Set the power at full treadle. The Start value
tracks with the End value.
• Power Progress Bar and Numerical Value - Display the current power value.
• Ultrasound More Information Button - Displays the More Information popup.
• Pulse Rate On/Off Button - Turns the Pulse Rate on or off.
• Pulse Rate Up/Down Buttons - Set the pulse rate.
• Pulse More Information Button - Displays the More Information popup.
Aspiration Panel
More Information Button
Flow/Vacuum Toggle
Reflux Label
1 2
Treadle Detent 1 Full Depression
Released
Increasing Treadle Depression
Figure 2-87 Surgery Screen: Fragmentation Mode - Fixed Submode (Advanced view shown)
Aspiration Panel
More Information Button
Flow/Vacuum Toggle
Vacuum Panel
1 2
Treadle Detent 1 Full Depression
Released
Increasing Treadle Depression
Figure 2-88 Surgery Screen: Fragmentation Mode - Linear Submode (Advanced view shown)
Aspiration Panel (This panel is available only in the Advanced View when the Flow
button is selected.)
• Flow End Up/Down Buttons - Set the flow level at the end of treadle
position 1.
• Flow Progress Bar and Numerical Value - Display the current flow level.
• Aspiration More Information Button - Displays the More Information
popup.
• Vacuum Limit Start and End Up/Down Buttons - Set the start and end
limits for vacuum.
• Vacuum Limit Progress Bar and Numerical Value - Display the current
vacuum level.
• Vacuum Limit Control Type Drop List - Determines whether the vacuum
limit is fixed or linear. In Fixed the limit is constant regardless of the
vacuum level. In Linear the limit varies depending on the vacuum level.
• Vacuum Limit More Information Button - Displays the More Information
popup.
• Flow / Vacuum Toggle - Switches between Flow mode and Vacuum mode.
Ultrasound Panel:
Same as Fixed submode except that the start value is always zero then the U/S power
is increased linearly as the treadle is depressed.
• Power On/Off Button - Turns ultrasound Power on or off.
• Power End Up/Down Buttons - Set the Power at full treadle.
• Power Progress Bar and Numerical Value - Display the current power value.
• Ultrasound More Information Button - Displays the More Information popup.
• Pulse Rate On/Off Button - Turns the Pulse Rate on or off.
• Pulse Rate Up/Down Buttons - Set the pulse rate.
• Pulse More Information Button - Displays the More Information popup.
Vacuum Panel:
• Vacuum End Up/Down Buttons - Set the vacuum level at the end of treadle
position 1.
• Vacuum Progress Bar and Numerical Value - Display the current vacuum level.
• Vacuum More Information Button - Displays the More Information popup, which
simplifies large value changes by providing slider controls. Also provides panel
specific configuration capabilities such as Drainbag Change.
Aspiration Panel
More Information Button
Flow/Vacuum Toggle
Vacuum Panel
1
Treadle Full Depression
Released
Figure 2-89 Surgery Screen: Fragmentation Mode - Momentary Submode (Advanced view shown)
Aspiration Panel (This panel is available only in the Advanced View when the Flow
button is selected.)
• Flow End Up/Down Buttons - Set the flow level at full treadle.
• Flow Progress Bar and Numerical Value - Display the current flow level.
• Aspiration More Information Button - Displays the More Information popup.
• Vacuum Limit Start and End Up/Down Buttons - Set the start and end limits for
vacuum.
• Vacuum Limit Progress Bar and Numerical Value - Display the current vacuum
level.
• Vacuum Limit Control Type Drop List - Determines whether the vacuum limit is
fixed or linear. In Fixed the limit is constant regardless of the vacuum level. In
Linear the limit varies depending on the vacuum level.
• Vacuum Limit More Information Button - Displays the More Information popup.
• Flow / Vacuum Toggle - Switches between Flow mode and Vacuum mode.
Ultrasound Panel:
Same as Fixed submode except that there is no On/Off button to turn U/S power Off.
• Power End Up/Down Buttons - Set the power at full treadle. The Start value
tracks with the End value.
• Power Progress Bar and Numerical Value - Displays the current power value.
• Ultrasound More Information Button - Displays the More Information popup.
• Pulse Rate On/Off Button - Turns the Pulse Rate on or off.
• Pulse Rate Up/Down Buttons - Sets the pulse rate.
• Pulse More Information Button - Displays the More Information popup.
Aspiration Panel
More Information Button
Flow/Vacuum Toggle
Vacuum Panel
m
cuu
g Va
a sin
re
Irrigation ON Inc
1 2
Treadle Detent 1 Full Depression
Released
Increasing Treadle Depression
In “Standard” display mode, only the Vacuum mode controls are available. The
controls for each panel in I/A mode have the following functions:
Vacuum Panel:
• Vacuum End Up/Down Buttons - Set the vacuum level at full treadle.
• Vacuum Progress Bar and Numerical Value - Display the current vacuum level
• Vacuum More Information Button - Displays the More Information popup, which
simplifies large value changes by providing slider controls. Also provides panel
specific configuration capabilities such as Drainbag Change.
Aspiration Panel (in Advanced View only when Flow mode is selected):
• Flow Start and End Up/Down Buttons - Set the flow level at start and full treadle.
• Flow Progress Bar and Numerical Value - Display the current flow level.
• Aspiration More Information Button - Displays the More Information popup.
• Vacuum Limit Start and End Up/Down Buttons - Set the start and end limits for
vacuum.
• Vacuum Limit Progress Bar and Numerical Value - Display the current vacuum
level.
• Vacuum Limit More Information Button - Displays the More Information popup.
• Flow / Vacuum Toggle - Switches between Flow mode and Vacuum mode.
• Vacuum Limit Control Type Drop List - Determines whether the vacuum limit is
fixed or linear. In Fixed the limit is constant regardless of the vacuum level. In
Linear the limit varies depending on the vacuum level.
Aspiration Panel
More Information Button
Flow/Vacuum Toggle
Vacuum Panel
um
acu
ingV
r eas
Inc
Momentary Scissors Cut when Bimanual
mode on.
In “Standard” display mode, only the Vacuum mode controls are available. The
controls for each panel in Extrusion mode have the following functions:
Vacuum Panel:
• Vacuum End Up/Down Buttons - Set the vacuum level at full treadle. The Start
value is always zero.
• Vacuum Progress Bar and Numerical Value - Display the current vacuum level.
• Vacuum More Information Button - Displays the More Information popup, which
simplifies large value changes by providing slider controls. Also provides panel
specific configuration capabilities such as Drainbag Change.
Aspiration Panel (in Advanced View only when Flow mode is selected):
• Flow End Up/Down Buttons - Set the flow level at full treadle.
• Flow Progress Bar and Numerical Value - Display the current flow level.
• Flow More Information Button - Displays the More Information popup.
• Vacuum Limit Start and End Up/Down Buttons - Set the start and end limits for
vacuum.
• Vacuum Limit Progress Bar and Numerical Value - Display the current vacuum
level.
• Vacuum Limit Control Type Drop List - Determines whether the vacuum limit is
fixed or linear. In Fixed the limit is constant regardless of the vacuum level. In
Linear the limit varies depending on the vacuum level.
• Vacuum Limit More Information Button - Displays the More Information popup.
• Flow / Vacuum Toggle - Switches between Flow mode and Vacuum mode.
• Reflux Label - Read Only display of the current reflux configuration together with
its current value.
• Reflux More Information Button - Displays the Reflux More Information popup.
Cutting Panel:
• Cut Rate End Up/Down Buttons - Set the cut rate.
• Cut Rate Progress Bar and Numerical Value - Display the current cut rate.
• Cutting More Information Button - Displays the More Information popup.
• The Load Plunger button is used to install a plunger, should this be required.
• The Preload IOL button is used by the nurse to prepare the IOL injector by
advancing the lens to the preload lens position. Alternatively, the doctor
can simply press the footpedal into position 2 and the preload activity will
automatically proceed.
• The Retract button is used to retract the handpiece plunger when lens insertion is
completed or when otherwise necessary. Alternatively, pressing and holding the
Retract button on the footswitch can also be used to retract the inserter.
During each of these activities a green progress bar appears to show the activity, and
a Cancel button also appears that allows the user to stop the activity at that point (see
Figure 2-92).
PRECAUTION: The default values for the Initial Rate and Pause ensure proper IOL
injection over a worst case range of IOL size and ambient temperature conditions.
Please refer to the INTREPID™ AutoSert™ IOL Injector DFU and consult with your
Alcon representative for additional guidance in adjusting these parameters for your
environment.
After lens insertion (Initial Rate, Pause, Final Rate), the footpedal must be released
and the Retract button pressed to retract the inserter. The footpedal can be released
out of position 2 during these steps, causing a pause in the insertion activity. Pressing
into position 2 again causes the activity to resume from the point it stopped.
Position 1 Position 2
• In SETUP: • PRELOAD
Cancels any setup • INJECTION
FOOTSWITCH operation in progress - Initial Rate
CONTROL - Pause
• In SURGERY:
No Action - Final Rate
CAUTIONS
• Do not ultrasonically clean the IOL injector connector. Ultrasonic cleaning of IOL
injector connector will cause irreparable damage.
• Use care when handling handpiece, particularly when cleaning. Always clean
handpiece over a surface cushioned with a pad or rubber mat.
• Be sure handpiece cable connector is dry before connecting it to the console.
• Do not disconnect cable connector from Constellation™ system console until the
handpiece plunger is fully retracted.
• Do not immerse the IOL injector in any fluid when the plunger is not retracted.
• As part of a properly maintained surgical environment, it is recommended that
a backup IOL injector be made available in the event the AutoSert™ IOL injector
handpiece does not perform as expected.
WARNINGS!
• The INTREPID™ AutoSert™ IOL Injector is non-sterile and must be cleaned
and sterilized prior to, and immediately after, each use.
• Never immerse the IOL injector in liquid after autoclaving; allow it to air cool
for at least 15 minutes. Quenching could result in a potentially hazardous
condition for the patient.
• The AutoSert™ IOL Injector delivery system is for the implantation of Alcon
qualified AcrySof ™ foldable IOLs. Unqualified lenses shall not be used with the
system. See INTREPID™ AutoSert™ IOL Injector DFU or AcrySof ™ IOL DFU, or
contact your Alcon representative, for qualified lens/cartridge combinations.
• The cartridge/IOL combination listed in the DFU, along with Alcon settings,
has been validated per section 5 of BS EN ISO 11979-3:2006. Appropriate use
of injector handpiece settings is important for successful IOL implantation.
Inappropriate use of settings may lead to a potentially hazardous condition
for the patient.
• Fully retract plunger before detaching nosecone from AutoSert™ IOL Injector;
otherwise, this could expose non-sterile portion of shaft and result in a
potentially hazardous condition for the patient.
• The metal reusable plunger must be sterilized after each use. The reusable
plunger is to be installed onto the handpiece or into the wrench prior to
sterilization.
Aspiration Panel
More Information Button
Flow/Vacuum Toggle
Vacuum Panel
NOTE: The Constellation™ Laser determines the 532 green laser maximum
available power and limits the user setting to that maximum value if less than
2 W. The maximum selectable power may be less than 2 W (2000 mW) because
of the degradation of the laser engine over time.
• Duration Up/Down Buttons - The Duration buttons adjust the exposure time to the
following values in milliseconds:10, 20, 50, 100, 150, 200, 250, 300, 400, 500,
700, 1000, 1500, and 2000 ms. This setting is only available in Repeat or Single
Shot modes.
Vacuum Panel:
• Vacuum On/Off Button - Turns vacuum off or on.
• Vacuum End Up/Down Buttons - Sets the vacuum level at full treadle. The Start
value is always zero.
• Vacuum Progress Bar and Numerical Value - Displays the current vacuum level.
• Vacuum More Information Button - Displays the More Information popup, which
simplifies large value changes by providing slider controls. Also provides panel
specific configuration capabilities such as Drainbag Change.
The following Vacuum panel controls are available only in the Advanced view:
• Flow Limit On/Off Button - Turns Flow Limit on or off. When the
maximum rate is reached, the vacuum level can no longer be increased. If
the Flow Limit is turned off, the vacuum level is limited only by the End
value.
• Flow Limit Start and End Up/Down Buttons - Set the start and end limits
for flow rate.
• Flow Limit Progress Bar and Numerical Value - Display the current flow rate.
• Flow Limit More Information Button - Displays the More Information
popup.
• Flow Limit Control Drop Down List - Determines whether the flow limit
is fixed or linear. In Fixed, the limit is constant regardless of the flow
level. In Linear, the limit varies depending on the footswitch treadle
position.
• Flow / Vacuum Toggle - Switches between Flow mode and Vacuum mode.
• Reflux Label - Read Only display of the current reflux configuration
together with its current value.
• Reflux More Information Button - Displays the Reflux More Information
popup.
Forceps Pressure
15% End Limit
e
Pressur
eps
ing Forc
Increas
Start Pressure
WARNING!
Ensure proper scissors tip attachment to pneumatic handpiece. Prior to use in
eye, depress footpedal\button to ensure proper tip function.
Cutting Panel:
• Cut Rate End Up/Down Buttons - Set the cut rate end limit.
• Cut Rate Progress Bar and Numerical Value - Display the current cut rate.
• Cutting More Information Button - Displays the More Information popup.
Forceps Panel:
• Bimanual On/Off Button - Turning Bimanual mode on allows the control of the
pneumatic forceps while the system is in Scissors mode. All controls function the
same as when the system is in Forceps mode (see Forceps mode for a description).
te
Ra
C ut
s ing
rea
Inc
1 2
Treadle Detent 1 Full Depression
Released
Increasing Treadle Depression
15%
Cut Pressure End Limit
re
ssu
Pre
tting
Cu
Start Pressure
1 2
Treadle Detent 1 Full Depression
Released
Increasing Treadle Depression
Cutting Panel:
• Pressure Start Up/Down Buttons - Set the pressure at treadle start.
• Pressure End Up/Down Buttons - Set the pressure at full treadle.
• Pressure Progress Bar and Numerical Value - Display the current cut rate.
• Cutting More Information Button - Displays the More Information popup.
• Calibrate On/Off Button - Enters Calibration Mode allowing the user to select and
set the pressure at Start and Close.
- When Start is selected, the Start pressure is applied to the port and the Start
Up/Down buttons are active on the Pressure control to allow adjustment of the
Start pressure.
- When Close is selected, the Close pressure is applied to the port and the Close
Up/Down buttons are active on the Pressure control to allow adjustment of the
Close pressure.
- Pressing the Save Calibration Values button saves these values.
Forceps Panel:
• Bimanual On/Off Button - Turning Bimanual mode on allows the control of the
pneumatic forceps while the system is in Scissors mode. All controls function the
same as when the system is in Forceps mode (see Forceps mode for a description).
CAUTION
Always use Alcon-supplied Viscous Fluid Control Kits and follow all Directions for
Use. Do not use VFC without the plunger/stopper supplied with the kit. Do not aspirate
fluids directly into the console; this will cause damage to the console, increase risk of
electrical shock, and void all warranties.
• Vacuum End Up/Down Buttons - Set the vacuum level at full treadle. Start value
is always zero.
• Vacuum Progress Bar and Numerical Value - Display the current vacuum level.
• Extraction More Information Button - Displays the More Information popup that
simplifies large value changes by providing slider controls.
m
uu
ac
ingV
reas
Inc
WARNINGS!
• Double check the cannula connected to the syringe for a tight connection. It
must not be allowed to come loose.
• Adjust the Max Limit air pressure in accordance with the viscosity of fluids to
be injected.
re
ssu
n Pre
e ctio
Inj
BIMANUAL MODE su
re
r es
nP
tio
ec
Inj Vacuum Start Limit
1 2
Treadle Detent 1 Full Depression
Released
Increasing Treadle Depression
The following Vacuum panel controls are available only in the Advanced view:
• Reflux Label - Read only display of the current Reflux configuration and its
current value.
• Reflux More Information Button - Displays the Reflux More Information popup
allowing the selection of Proportional (1-120 mmHg) or Micro (10-100%)
Reflux.
The Print and Print Laser Form buttons are used to obtain a print-out of the End Case
Form and Laser Form respectively. The Laser Form is comprised of the End Case
Form’s first header and the Laser metrics table only. Modification of the End Case
Form’s layout and content is accomplished using the Setup Form button, which when
pressed, displays the End Case Form Setup popup.
Metrics Tabs
The End Case Metrics screens are accessed through the labeled tabs next to the
Summary panel. Tabs are provided for Anterior, Posterior, Laser, and Consumables.
When selected, each tab displays the associated metrics for that tab as shown by the
Anterior tab in Figure 2-99. The Consumables tab displays all consumable items that
have been detected by the system.
Setup Form
The End Case Form Settings screen shown in Figure 2-100 is displayed by pressing
the Setup Form button on the End Case screen (Figure 2-99). The screen shows a
picture of the End Case Form print-out and provides controls for navigating to other
pages in the print-out, and for customizing the layout/content of the print-out.
The buttons at the bottom of the Form Settings screen perform the following actions:
• Page arrow buttons - Pressing these buttons allows the user to move through each
page of the printout.
• Save button - Pressing the Save button causes the system to save the various
layout and content customization settings and return to the End Case screen.
• Cancel button - Returns the system back to the End Case screen without saving
changes made to content and layout.
Pressing the Edit Form button allows the
user to customize the layout and content of
the printout.
Edit
Button
To insert a new table after the selected table, follow these steps:
1. In the Table section of the Edit Form panel, press the Insert button (Ins). A table
with two rows and three columns appears below the selected table and the new
table is now the selected table. To delete the table, press the Delete button (Del).
The Table Type is selected from the Type dropdown list in the Table section of the
Edit Form panel. The default table type for new tables is Custom which contains
no entries or formatting (see Customizing Table Cells for information on editing
individual cells).
2. Select the type of table desired from the Type dropdown list. There are five
preformatted tables available from the list which automatically pull data from the
procedures performed. The Custom selection allows the user to create a custom
table to meet their particular requirements. Preformatted tables may also be
customized according to the users requirements.
3. To increase the height of the selected row, press the Height% dropdown button
and select an entry between 1 and 20%. The default row height is 2, so selecting 1
will result in a smaller row height and all selections above 2 will result in a larger
row height. The height of the selected row is displayed on the Height% button.
4. To insert or delete a row, press the Ins (insert) or Del (delete) button in the Row
section of the Edit Form panel.
5. To increase the width of the selected column, press the Width% dropdown button
and select an entry between 5 and 100%. The default column width is 30, so
selecting 5 through 25 will result in a smaller column width and all selections
above 30 will result in a larger column width. The width of the selected column is
displayed on the Width% button.
6. To insert or delete a column, press the Ins (insert) or Del (delete) button in the
Column section of the Edit Form panel.
Additionally, the user can select an area on the Connection help diagram. In Figure
2-101, the Left Connection Panel is selected and each instrument that can be
connected to the panel is listed. Pressing on the instrument name displays a popup
that allows the user to disconnect the current instrument and connect another from the
list. After connecting the desired instruments press the Close button and the system
displays the main screen as shown in Figure 2-102. The user can return to the Demo
Mode Setup screen by pressing Options then Demo Options.
Demo
Mode
Indicator
Exits Demo Mode
and shuts down
the system
On the main screen, the “Demo Mode” label indicates that the system is in demo
mode. This label is displayed in all Demo Mode screens: Setup, Surgery, and End
Case screen.
Surgery Setup:
• Vit 3D mode
• Infusion ON
Footswitch Simulator: Laser - To simulate firing the laser, place the system in Laser
mode, select the desired settings, select “Ready” mode, and select the Laser tab on the
footswitch simulator (see Figure 2-105).
Surgery Setup:
• Laser mode
• Single Shot Treatment
• Ready mode
Vitrectomy Probes
• 20, 23, 25, 25+™, and 27+™ GA UltraVit™ Probe
• 20 and 23 GA AVIT UltraVit™ Probe
• 23, 25+™and 27+™ GA HyperVit™ Probe
WARNINGS!
Appropriate use of Constellation™ Vision System parameters and accessories is
important for successful procedures. Use of low vacuum limits, low flow rates,
low irrigation pressure, high power settings, extended power usage, power
usage during occlusion conditions (beeping tones), failure to sufficiently aspirate
viscoelastic prior to using power, excessively tight incisions, and combinations
of the above actions may result in significant temperature increases at incision
site and inside the eye, and lead to severe thermal eye tissue damage.
Directing energy toward non-lens material, such as iris or capsule, may cause
mechanical and/or thermal tissue damage.
Use of an ultrasonic handpiece other than the OZil™ torsional or the U/S, or use
of a handpiece repaired without Alcon authorization, is not permitted, and may
result in patient injury, including potential shock hazard to patient and/or operator.
Use of the OZil™ torsional or the U/S handpiece in the absence of irrigation flow
and/or in the presence of reduced or lost aspiration flow can cause excessive
heating and potential damage to the cornea and other tissues.
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.
CAUTIONS
Do not test or operate the OZil™ torsional or U/S handpiece unless the tip is immersed
in BSS™ sterile irrigating solution or distilled water or is in surgical use. Irreparable
damage to the handpiece and tip can result if run dry.
Ensure that test chamber is filled with BSS™ sterile irrigating solution before tuning
the OZil™ torsional or U/S handpieces. Tuning a handpiece dry may result in premature
tip failure and breakage.
NOTE: The Constellation™ Vision System does not support the Centurion™
OZil™ handpiece.
s o ni
ltra
U scillation
O
nd
sou
Ultra
WARNINGS!
For phaco surgery, use only Alcon-certified Turbosonics™ MicroTip™ configurations
(.9 mm). Alcon does not recommend the use of standard Turbosonics™ tips (1.0
mm) with the Constellation™ Vision System. The use of 1.1 mm phaco tips could
result in undesirable fluidic instability. Please select irrigation and aspiration
settings which are appropriate for the tip selected.
Poor clinical performance will result if tip is not secured tightly to the handpiece.
Read all information printed on the consumable packs prior to use.
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.
Standard U/S Tip - The 1.1 mm TurboSonics™ tip Kelman™ Tip - The Kelman™ tip has a bent shaft
with the round shaft is the original, classical U/S which generates transverse ultrasound motion, in addition
tip shape. The 0.9 mm has a smaller diameter shaft. to the conventional longitudinal motion, to enhance cutting
efficiency. In addition, the bend allows better visibility
during the surgical procedure.
The Aspiration Bypass System - The ABS™ tip contains Flared ABS™ Tip - The flared tip has a larger proximal
a small hole in the distal portion of the tip's wall. port, providing increased holding force. They narrow in the
middle of the shaft, thus allowing smaller incisions and
improving occlusion breaks by reducing outflow from the
small hole anterior chamber, following occlusion breaks. Flared tips
also have the Aspiration Bypass System feature, to further
enhance performance.
Figure 2-112 Infiniti™ U/S Handpiece shown with Infusion Sleeve and Bubble Suppression Insert
Depending on the needs and technique preferred by the surgeon, various styles of
infusion sleeves are available as listed in Table 2-5.
•
Ultraflow™ IT Handpiece and Interchangeable Tips - The Ultraflow™ IT consists
of a handpiece body that accepts interchangeable tips. These tips do not require an
adapter or infusion sleeve as they contain a built-in metal infusion sleeve.
•
Ultraflow™ IT Handpiece and Threaded Tip Adapter - Reusable I/A tips with
TurboSonics™ silicone infusion sleeves can be used with the Ultraflow™ IT
handpiece with threaded tip adapter.
•
Ultraflow™ SP Handpiece (Single-Piece with fixed tips) - The Ultraflow™ SP
consists of a single-piece handpiece with irrigation tip, threaded tip adapter, or I/A
tip with a built-in metal infusion sleeve. Various tip configurations are available.
WARNINGS!
Use of non-Alcon surgical reusable or disposable I/A handpieces that do not meet
Alcon surgical specifications, or use of an Alcon handpiece not specified for use
with the Constellation™ Vision System, may result in a fluidic imbalance. This, in
turn, may cause a shallowing or collapsing of the anterior chamber.
Exceeding the recommended level of 100 mmHg with a 0.5 mm or larger I/A tip
may cause anterior chamber shallowing and/or incarceration or tearing of the
posterior capsule.
I/A tips are not to be used with the OZil™ torsional or U/S handpieces.
O-Rings
Straight Tip
O-Rings
Figure 2-114 Ultraflow™ IT handpiece with infusion sleeve, reusable I/A tip, and threaded tip adapter
O-Ring Extractor
Large O-Rings
Small O-Rings
Figure 2-115 Ultraflow™ O-ring tool with large and small O-rings
The IOL injector comes with a detachable and reusable plunger. Please refer to the
INTREPID™ AutoSert™ IOL Injector DFU for instructions on proper preparation and
use of the handpiece and plunger.
WARNINGS!
• The INTREPID™ AutoSert™ IOL Injector is non-sterile and must be cleaned and
sterilized prior to, and immediately after, each use.
• Never immerse the IOL injector in liquid after autoclaving; allow it to air cool for at
least 15 minutes. Quenching could result in a potentially hazardous condition for
the patient.
• The AutoSert™ IOL Injector delivery system is for the implantation of Alcon qualified
AcrySof ™ foldable IOLs. Unqualified lenses shall not be used with the system. See
INTREPID™ AutoSert™ IOL Injector DFU or AcrySof ™ IOL DFU, or contact your Alcon
representative, for qualified lens/cartridge combinations.
• The cartridge/IOL combination listed in the DFU, along with Alcon settings, has
been validated per section 5 of BS EN ISO 11979-3:2006. Appropriate use of injector
handpiece settings is important for successful IOL implantation. Inappropriate use
of settings may lead to a potentially hazardous condition for the patient.
• Fully retract plunger before detaching nosecone from AutoSert™ IOL Injector;
otherwise, this could expose non-sterile portion of shaft and result in a potentially
hazardous condition for the patient.
• The metal reusable plunger must be sterilized after each use. The reusable plunger
is to be installed onto the handpiece or into the wrench prior to sterilization.
Specialized cassettes for posterior and anterior procedures are available and have only
those ports necessary to perform the associated procedure. See Consumable Pack
Configurations on the following pages for detailed information on the type of cassette
contained in each pack.
WARNINGS!
All fluids aspirated during surgery should be treated as biohazards. Take appropriate
precautions when handling instruments and lines in contact with aspirated fluids.
Drain bag volume should not exceed 500 ml “Max. Capacity.” Exceeding this
volume may result in a biohazardous condition.
Drain Bag
The packs are available in various gauge/size offerings to suit the needs of the
surgeon. The basic options for the Constellation™ Consumables Procedure
Packs are listed in Table 2-6. Contact your Alcon representative for available Pack
configurations.
WARNING!
Attach only Alcon supplied consumables to console and cassette luer fittings. Do
not connect consumables to the patient's intravenous connections.
NOTE: Refer to the Directions For Use (DFU) included with each accessory kit/
consumable pack for detailed instructions on how to setup that accessory.
INTRODUCTION
This section details the recommended initial setup for the Constellation™ Vision
System. These procedures may be modified to conform to hospital requirements and
practices as you become experienced in using the system.
The procedures are divided into two columns and presume a surgical team of three
people: Surgeon and Scrub Nurse in the sterile field, and a Circulating Nurse in
the non‑sterile field. In the left column a directive is given; in the right column the
responsible team member is identified.
Any problems pertaining to setup and check‑out procedures should first be directed to
the Troubleshooting section of this manual. If questions still exist, contact the Alcon
Technical Services Department or your local Alcon representative.
IMPORTANT NOTE: For accessory setup and use information, please refer to
the "Directions for Use" included with each accessory.
In addition, the Constellation™ Vision System contains setup Help videos that can be
accessed by pressing the Help button located at the top of the display.
POWER UP SEQUENCE
When the power switch is turned on, and the standby switch is pressed, the
Constellation™ Vision System logo screen appears while the system performs
its self-test diagnostics. The system is capable of detecting and reporting a wide
range of advisories, errors, and faults. Many of these are checked during the power
up procedure. If an operational condition is detected during power up, the user is
informed and the instrument becomes non‑operational until the advisory, error, or
fault is corrected. Upon successful completion of the self-tests, the system enters the
setup screen.
CAUTION
Do not use portable socket outlets or power strip with this system.
CAUTION
U/S and fragmentation handpieces must be at room temperature before
use. Allow handpiece to air cool after steam autoclave (at least 15
Circulating Nurse
minutes). Never immerse in liquid to cool.
WARNING!
The maximum allowable load on the instrument tray is 20 lb (9 kg). If the load
exceeds this limit, the tray arm will automatically lower itself in order to avoid
tipping the system over. Additionally, if the instrument tray is positioned over a
patient, a mayo stand should be placed beneath it to avoid a potential collapse
of the tray arm onto the patient.
WARNING!
Place the instrument tray in the stored position (see Figure 3-2) prior to
transportation to avoid a situation that could cause the system to tip.
1 Pull the Horizontal/Vertical Latch Release (see Figure 3-1) and rotate the
instrument tray to the vertical position shown in Figure 3-2.
2 Pull the Position Latch Release and move the tray and arm assembly into the
stored position shown in Figure 3-2.
Instrument Tray in the vertical position Instrument Tray/Arm in the stored position
CAUTION
DO NOT push or pull on the tray arm without pulling
the green release handle - damage to sensitive
components may result (see Figure 3-3).
Figure 3-4 Pressure Hose Configuration for Facility with an Pressure Source
Figure 3-7 Connecting the SF6 Regulator to the SF6 Gas Bottle
2 For C3F8: Connect the C3F8 Regulator to the C3F8 Gas Bottle and tighten the
nut closest to the valve using a wrench as shown in Figure 3-8. DO NOT adjust
the center nut.
Adjust nut closest to valve. DO NOT adjust center nut.
Figure 3-8 Connecting the C3F8 Regulator to the C3F8 Gas Bottle
4 Attach appropriate quick-connect fitting from the tubing set on the rear of the
table top console to the regulator (see Figure 3-10). These connectors are color-
coded and configured to prevent misconnection.
6 Open the valve on the bottle by rotating the colored handle counterclockwise.
NOTE: The pressure regulators are pre-set at the factory and do not need
user adjustment.
All changes to the laser setup and adjustments to the various laser parameters are
made through the Constellation™ system touch screen. For additional information,
refer to the Laser Setup Panel and the Laser Mode Surgery screen later in this section
of the manual.
NOTE: In tethered mode, all PurePoint™ Laser front panel controls except for
the emergency switch are disabled.
This serial port will provide start/stop Constellation™ Vision System Rear Panel
control of a RS-232 based video recorder (system with Standard Definition Video Overlay)
VCR output
to Monitor input
Video Recorder
Monitor
• Header - The header displayed along the top of the screen includes the Alcon
and Constellation™ Vision System logos. Both the header and footer are removed
after the system has gone through one complete display cycle and are displayed
again when the system enters a new mode or submode, or a user action causes any
of the data fields in the footer to be refreshed.
• Footer - The footer is displayed along the bottom of the screen. The content of the
center area of the footer alternates between displaying doctor, procedure, and step
name (when applicable).
• Globals - Global control values are displayed on the left side of the screen. Global
values are only displayed when the corresponding global function is turned on.
• Surgical Values - Surgical values are diplayed on the right side of the screen
and are dependent on the current mode/submode. Both the Start and End
setpoint values are displayed for progress bar controls. When the treadle is NOT
depressed, or for a momentary surgical function the corresponding footswitch
button is not pressed, 0 is displayed. When the treadle or footswitch button is
depressed, the actual values are displayed in a larger font size and the progress bar
is updated according to the current treadle position.
• Indicators:
- Footswitch - A Footswitch icon is displayed in the top left corner of the
screen. The current treadle position is displayed in the center of the icon.
When a footswitch switch is depressed, an arrow is displayed next to the
corresponding switch.
- Laser State - The current state of the Laser is indicated on the Laser
surgical control on right side of the screen in Laser modes. When the Laser
transitions between Standby, Ready, and Firing states, the displayed text on
the Laser control is updated and the background color is changed to match
the new state of the Laser.
• Status - The Status Area is located in the bottom left corner of the screen and
displays the status of the following items: Occlusion, Diathermy, Micro-Reflux,
Proportional Reflux, and Continuous Reflux.
SD Camera HD Camera
Eye Eye
VCR output
to Monitor input
HD Video Recorder
HD Monitor
NEGENUITY™ EPU
WARNINGS!
1. If any item in the pack is received in a defective condition, Alcon is to be notified immediately.
Do not use any of the contents if the sterile package is damaged or the seal is broken in any
way. In these cases, please contact:
By Phone:
In USA (800) 757-9780
Ask for Medical Safety
International (817) 293-0450
Or contact local Alcon Representative
By Mail:
Alcon Research, Ltd
Attention: Medical Safety (AB2-6)
6201 South Freeway
Fort Worth, TX 76134-2099
USA
By E-mail: MedicalSafetyHouston@alconlabs.com
Each pack is identified by a lot number which provides traceability and should be given to
Medical Safety Department when discussing the pack.
2. Improper usage or assembly could result in a potentially hazardous condition for the patient.
Mismatch of consumable components and use of settings not specially adjusted for a
particular combination of consumable components may create a patient hazard.
3. Visually confirm that adequate infusion flow is occurring prior to attachment of the infusion
cannula to the eye.
4. Do not operate Vitrectomy probes in air. This could result in performance degradation and/or
potential hazard.
5. Replace Vitrectomy Probe if any of the following conditions are observed:
a. Excessive air bubbles are in the aspiration line.
b. Air bubbles are exiting the cutter port.
c. The cutter does not fully close or does not move when the probe is actuated.
d. The cutting port is not open when the probe is idle.
e. If a reduction of cutting capability or vacuum is observed during the surgical
procedure, stop immediately and replace the probe.
6. Minimize the light intensity and duration of exposure to the retina to reduce the risk of retinal
photic injury.
7. Use of incisions that are smaller than recommended during lens removal can lead to
mechanical and/or thermal damage to the eye tissue.
INTRODUCTION
This section of the manual is designed to inform the operator of basic care and
maintenance of the instrument. If a problem occurs on the instrument, call the Alcon
Technical Services Department and give details of the breakdown circumstances and
effects. From these elements, a specialized technician will evaluate the problem and
determine the maintenance requirements.
CAUTION
There are no operator replaceable parts, including the illuminator lamps. Contact Alcon
Technical Services for all servicing issues.
WARNING!
The Constellation™ Vision System battery can only be serviced by a factory-trained
Alcon service personnel. Access by untrained personnel can lead to injury.
• Follow cleaning and maintenance schedules outlined in this section of the manual.
• Periodically check chassis appearance.
• Pay attention to correct operation of controls, connectors, and indicators.
• Damaged hardware must be replaced to ensure safe operation. Call Alcon
Technical Services for assistance.
WARNING!
A qualified technician must perform a visual inspection of the following components
every twelve months:
• Warning Labels (see section one of this manual)
• Power Cord
In case of a deficiency, do not use the system; call Alcon Technical Services.
A qualified technician must check ground continuity for leakage current every
twelve months to ensure they are within the applicable standards (for example:
EN60601-1/IEC601-1). Values must be recorded, and if they are above the applicable
standards, do not use the system; call Alcon Technical Services.
CAUTION
Do not remove tubing from cassette or fluid in cassette reservoirs will leak down front
of machine.
1 Select End Case - Press End Case tab at top right corner of screen. The system
will confirm that you want to end the case. Select Yes or No.
2 Ensure infusion clamp is closed and turn Infusion off - Press “Infusion” icon
at top left corner of screen to turn infusion off. The system will confirm that
you want to turn off infusion. Select “Continue” and the cassette will start the
cleaning process.
3 Once cleaning is complete, remove irrigation bottle from hanger and set aside.
Remove spike from irrigation bottle.
4 Push ejection button above cassette to remove. Discard cassette with tubing per
facility guidlines.
5 Move the irrigation bottle holder to its storage position.
6 Press Standby switch located at top of rear panel (or Shutdown in Options
menu) to remove operating power from the system.
7 Turn the Main power switch OFF. It is located in the middle of the rear panel
above the power cord.
8 Remove air hose. Turn off C3F8 and SF6 valves.
9 Disconnect the power cable from the wall receptacle and wind the cable around
the cord wrap.
10 Place the footswitch and cable in storage compartment in front of base.
11 If required, the front panel, the console, the footswitch, and the remote control
may be wiped with non-corrosive germicidal solution, alcohol, or mild soap and
water.
CAUTIONS
• Do not clean console or accessories using solvents or abrasives.
• Avoid spilling BSS™ solution, or moisture of any kind, around the electrical
handpiece connectors.
12 Clean handpieces, probes, cables, forceps, etc., as instructed in DFU's supplied
with each accessory.
WARNING!
The bulb of the xenon lamp is under constant high pressure. There is a risk it may
burst with explosive force if knocked or damaged. Protective measures:
- Keep the lamp in its protective sleeve at all times during installation
- If you are handling the lamp without its protective sleeve, always wear safety
goggles, a face mask, gauntlets with wrist protectors and a breast protector.
In the USA contact the Alcon Technical Services Department for lamp disposal at
800/832-7827. Outside the USA contact your local Alcon affiliate.
WARNING!
Changing batteries will cause the remote to default to channel A; therefore the
remote may need to be reset to the instrument's unique channel after installing
new batteries.
1 Loosen two captive screws on the rear cover with a standard slotted screwdriver
and remove cover.
2 Replace old batteries and replace cover (correct battery positions are identified
inside each battery slot). When closing the cover it is important that the rubber
buttons slide into the slots in other half of the remote without binding (see
Figure 4-1).
3 To check correct installation of batteries, press a backlight button on the side of
the remote and verify that the remote control buttons illuminate, then turn off
after a few seconds. If illuminated buttons don't turn off, rubber buttons are not
properly inserted into slots, so you must repeat the procedure.
4 Dispose of batteries following local governing ordinances and recycling plans.
Rubber Buttons(2)
must enter slots
without binding
CAUTION
Serious damage to the instrument may occur if these procedures are not performed by
qualified personnel.
Special Tools
• Computer with browser software (MicroSoft** Internet Explorer or equivalent);
TFTP file transfer program, or equivalent.
• Custom service ethernet cable (Alcon p/n 023-100)
• Power Meter, Thermopile type (Coherent FieldMaster w/ LM-10 head or
equivalent)
• Energy Meter (optional) for direct energy measurements (Ophir Nova meter, with
3A-P or PE25-BB head, or equivalent)
• Oscilloscope / Voltmeter (Fluke Scopemeter, or equivalent)
• Laser Safety Goggles (OD4 or above, at 532 nm wavelength)
• Optics cleaning kit, including spectroscopic grade methanol, lens paper, and air
blower
• LIO Voltage Load Box (Alcon dwg 995-5620-069)
• Timing Photocell (Alcon dwg 995-5320-038)
The ethernet cable used for service computer connection is a custom cable. Contact
Alcon Technical Services for more information.
WARNING!
Laser light emitted from the fiber and laser head is powerful enough to cause
serious eye or skin damage. Maintenance should be performed only by
properly trained personnel, following established guidelines for laser safety.
The use of protective eye wear is mandatory.
NOTE: Calibrated Power / Exposure Time may be verified by two different test
methods:
1) Watts X Time method: Use an oscilloscope to measure exposure
time, and power meter to measure output power, and perform the
multiplication to enter value in the energy matrix on the data sheet.
2) Energy method: If an appropriate energy-meter is available, enter
“N/A” for the exposure time and power fields on the data sheet, and use
the energy-meter to measure and record values directly into the energy
matrix.
Product of
0.50 W 0.51 0.00561 power x time entered
here and compared to
(0.00425 - 0.00575) tolerance in brackets.
4.2 Ensure that all calculated results are within the values listed in each matrix cell.
The listed values are ±15% of the set energy.
• If all calculated energy values are within the specified limits, the system
calibration is OK.
• If any of the calculated energy results are not within the specified limits,
the terminal efficiencies will need to be adjusted. Perform the "Setting the
Calibration Factor (Terminal Efficiencies)" procedure following Table 4-1,
or call Alcon Technical Services.
5 Aiming Beam Calibration
5.1 With the unit off, connect the service ethernet cable between the Constellation™
console “Tethered Laser” connector on the rear panel, and service computer
then turn the system ON. Allow two minutes for the Laser Module to initialize.
5.2 Type the IP address into the address box, and hit return. When the page loads,
enter the password. Click the Output Calibration tab at the top of the screen.
5.3 Adjust aiming beam power output for Port 1 as high as possible but less than
950 μW.
5.4 Click “Set Max Value” for Aiming Beam on the computer.
5.5 Repeat for Port 2.
>
0.10 W
ENDOPROBE
(0.0085 - 0.0115)
0.30 W
(0.0255 - 0.0345)
0.70 W
(0.0595 - 0.0805)
0.10 W
(0.0085 - 0.0115)
LIO
0.30 W
(0.0255 - 0.0345)
0.70 W
(0.0595 - 0.0805)
WARNING!
Laser light emitted from the fiber and laser head is powerful enough to cause
serious eye or skin damage. Maintenance should be performed only by properly
trained personnel, following established guidelines for laser safety. The use of
protective eye wear is mandatory.
1 With the unit off, connect the service ethernet cable between the Constellation™
console “Tethered Laser” connector on the rear panel and service computer, then
turn system ON. Allow two minutes for the laser module to initialize.
SYSTEM MESSAGES
The system communicates information to the user through the display of System
Messages which are displayed and described to the user as Faults, Errors, Advisories
or System Information. These terms are used to classify the level of response required
to ensure fail-safe operation of the system. The presentation of a System Message
alone does not indicate that a malfunction has occurred. System Messages typically
occur when the system detects a condition that is not met but is required for the
system to continue. System Messages and associated actions are intended functions
presented as a precursor to mitigate an unanticipated condition.
System Messages are priority based, with Fault Messages being the highest priority,
followed by Error Messages, Advisory Messages, and Information Messages. Each
type of message is color coded as follows:
• Fault:
- Recoverable Fault - Red stop sign with blue background
- Unrecoverable Fault - Red stop sign with black background
• Error - Yellow
• Advisory - Green
• Information - Blue
Each message also has a number associated with it that indicates the submodule
that prompted the message. The number range for each submodule in the system is
assigned as follows:
• Host Submodule - 1000 to 1999
• Supervisor Submodule - 2000 to 2999
• Fluidics Submodule - 3000 to 3999
• US/Diathermy Submodule - 4000 to 4999
• Table Top Illuminator Submodule - 5000 to 5999
• Pneumatics Submodule - 6000 to 6999
• Auxillary Illuminator Submodule - 7000 to 7999
• Laser Submodule - 8000 to 8999
The Event Log (shown in Figure 5-10) displays a list of the system messages that
have occurred on the system. It is recommended to view the Event Log for details of
a system message prior to calling your local Alcon representative for assistance.
For additional assistance in determining what action to take in the event a system
message is displayed, refer to the Troubleshooting Guide in Figure 5-11.
The system performs the following actions when a fault condition is detected:
• The applicable System Fault screen is shown with appropriate Fault Number and
one or more acknowledgment buttons.
• A fault tone is generated.
• All surgical functions are placed in a safe state.
• All operator input from the touch screen and footswitch is ignored (with the
exception of the [Start Recovery], [Quick Start], and [Shutdown] buttons).
The majority of all generated system faults are recoverable and the displayed Fault
message includes the following recovery instructions:
Recovery Instructions:
1) Stabilize eye. Leave infusion cannula in, remove other
instruments (i.e. vit probe/illuminator) and plug trocar
cannulas/sclerotomies.
2) Press the "Start Recovery" button.
After the system recovers from a fault, the system state is restored to the state when
the fault occurred.
Power Lost/Recovery
If the system experiences a loss of power, all surgical functions are stopped and the
"Power Lost" message shown in Figure 5-5 is displayed. If system power is not
restored within 1 minute, the system automatically powers down.
If power is restored within 1 minute, the system displays the "Power Recovered"
message and the system will be restored to the doctor and settings in use at the time
of power loss. Accumulated metrics and calibration state are not restored. In order to
resume a procedure after a loss of power, the handpieces/probes must be recalibrated/
reprimed.
Standby
Switch
Figure 5-6 Standby Switch Location and Quick Start Button on Fault Screen
2 Immediately clamp smaller infusion cannula tubing with hemostats. (See Figure
5-7). Infusion pressure will be off when Setup Screen is displayed.
NOTE: The yellow stopcock is optional and may not be part of setup.
Green Luer Fitting Yellow Stopcock
Infusion tubing
with Snap Clamp
Infusion Cannula
Infusion ON Button
7 Select “Start Prime”. NOTE: Priming will take about 1 minute to complete.
8 Press Infusion ON button and clear any bubbles.
9 Close the snap clamp.
10 Reconnect the green luer fitting.
11 Open snap clamp and remove hemostats from the smaller infusion tubing.
12 Select Doctor and Procedure, then continue the case.
Event Log
Figure 5-10 shows the Event Log where system messages are displayed that have
occurred during the previous seven days. The list can be filtered to display a specific
type of message by pressing the associated button on the right side of the screen.
1 Part contacts the patient or fluid path during surgery (an applied part).
2 Part contacts the patient or fluid path during surgery (an applied part).
The procedure packs are an assemblage of accessories (listed in the previous tables)
specifically for use with the Constellation™ Vision System. Contact your local Alcon
Representative for available Constellation™ Procedure Packs.
The PurePoint™ LIO is connected to the laser via a fiber optic cable for the treatment
and aiming beams, and by electrical cable for illumination. The illumination light is
adjustable from approximately 0 to 1000 lux using the illumination control knob on
the power supply.
A permanent Doctor Protection Filter protects the surgeon against incidental laser
beam reflections. The operator will have a colored† view through the Doctor
Protection Filter due to blocking of the 532 nm wavelength (green).
† Newer Doctor Protection Filters will have less tint than older ones.
WARNINGS!
The head-worn Laser Indirect Ophthalmoscope (LIO) is designed solely for examination
and treatment of the eye, particularly the retina.
Use only the illumination power supply provided on the Constellation™ Vision System
or the PurePoint™ Laser System (in tethered mode). It is specially designed for the
PurePoint™ LIO.
Insure that the selection on the Constellation™ Vision System display is LIO. It is the
responsibility of the operator to verify that the selection is correctly confirmed.
The operator will have a colored** (pink) view through the Doctor Protection Filter due to
blocking of the 532 nm wavelength (green).
The operator must be careful to avoid potential secondary reflections; therefore the room
used to treat the patient should be approved by a qualified laser safety officer.
All personnel in the treatment room must wear protective eyewear (OD 4 or above at 532
nm) when the system is in Standby, Ready, or Firing modes.
The laser delivery system is an integral part of the LIO and is not designed to be used
with an observer. Never use a teaching or observation system in conjunction with the LIO.
There is no eye protection provided for the observer.
Before each use of the headset, the operator must check the permanent Doctor Protection
Filter for scratches, breaks, or alterations. If there is any doubt, please call Alcon Technical
Services, and discontinue use of device.
There are potential hazards when inserting, steeply bending, or improperly handling of
the fiber optic cable. Not following the recommendations of the manufacturer may lead to
damage to the fiber or delivery system and/or harm to the patient or user.
Since the aiming beam passes down the same delivery system as the treatment beam,
it provides a good method of checking the integrity of the delivery system. If the aiming
beam spot is not present at the distal end of the delivery system, or its intensity is reduced
or it looks diffused, this is a possible indication of a damaged or not properly working
delivery system. If there is any doubt, contact Alcon Technical Services.
The use of flammable anesthetics or oxidizing gases such as nitrous oxide (N2O) and
oxygen should be avoided. Some materials - for example cotton wool when saturated with
oxygen - may be ignited by the high temperatures produced in normal use of the laser
equipment. The solvents of adhesives and flammable solutions used for cleaning and
disinfecting should be allowed to evaporate before the laser equipment is used. There is
also danger of ignition of endogenous gases.
A qualified technician must perform a visual inspection of the following components every
twelve months: warning labels, power cords, and fuses. In case of a deficiency, do not use
the system; call Alcon Technical Services.
A qualified technician must verify the LIO performance by performing an LIO calibration,
power output, and energy matrix test every twelve months to ensure the LIO is operating
within specifications. See Section Four of this operator's manual for instructions. If the
LIO is not operating within specifications, do not use the system; call Alcon Technical
Services.
A qualified technician must check and record ground continuity and both polarities for
leakage current every twelve months to ensure they are within the applicable standards
(for example: EN60601-1/lEC601-1). If they are above the applicable standards, or 50%
above initial measurement, do not use the system; call Alcon Technical Services.
Manufacture Date
Laser Aperture
NOTE: The LIO may use either of the label examples shown above depending upon the date of manufacture.
To pivot the overband, press the Overband Adjustment Knob with the right hand
and pivot the overband into the desired position (up for the “rest” position and down
for the “working” position). When the unit is properly adjusted, the overband can
be lowered into the same pre-selected working position. Once set, changing the
adjustments is required only if another examiner uses the instrument.
2. Place the LIO on your head and adjust the circumference and height using the
Circumference and Height Adjustment Knobs so that the headband is firmly
positioned but comfortable.
3. For convenience, use clothing clip to attach the fiber/cable assembly to clothing.
4. Move the eyepieces as close as possible to your eyes and look at the light spot
at a distance of 30 cm. A small object (such as a pencil) held in front of the
eyepieces at 30 cm must be clearly focused.
5. Using the Delivery Mirror Control Knob, adjust the optics so that the light spot
is centered vertically in your field of view, then tighten the Observation Optics
Adjustment Knob.
6. If the light spot is not centered horizontally, adjust the headband left or right
accordingly.
7. Adjust the pupil distance setting by viewing the light spot alternately with the
left eye then the right eye, and sliding the eyepieces so that the spot is centered
within your field of view.
8. Remove the LIO and look at the scale on the eyepieces to insure that the pupil
distance is symmetrical. If not, center the headset and readjust the eyepieces.
Correct adjustment of the optics is particularly important when examining small
pupils.
Once set, changing the adjustments is required only if another examiner uses the
instrument.
The Delivery Mirror Control Knob can be rotated to move both the illumination beam
and the laser beam in the vertical plane.
CAUTION
Do not use the LIO with the illumination power supply set at maximum intensity for
more than 10 continuous minutes. The LIO must be allowed to cool down at least
20 minutes between uses. Use as little observation/illumination light as possible and
always switch power supply OFF using the illuminator power knob.
Circumference
Adjustment Knob
(on backside of band)
Observation Optics
Adjustment Knob
Aperture Lever
Delivery Mirror
Control Knob
WARNING!
All the personnel in the room during the operation must wear protective safety
eyewear with a minimum optical density OD 4 to filter 532nm radiation.
Before each use of the headset, the operator must examine the permanent
Doctor Protection Filter for scratches, breaks, or alterations by looking through
the ocular lens. If there is any doubt, discontinue use of device and please call
Alcon Technical Service.
NOTE: The PurePoint™ LIO is shipped with +2 diopter ocular lenses installed.
These may be changed with 0 (zero) diopter lenses.
1. If desired, change the ocular lenses by unscrewing the eyecup retainer in the
counterclockwise direction, change each lens, and replace the eyecup retainers.
Ensure that the new lenses are clean; i.e. no fingerprints or debris. Refer to the
PurePoint™ LIO maintenance section for cleaning instructions.
Figure 6-5 Eyecup Retainers and Ocular Lens on the PurePoint™ LIO
2. Turn the Constellation™ Vision System console power ON and make the
appropriate selections.
3. Select the appropriate illumination field size by toggling the illumination
aperture lever to the desired setting.
4. Adjust the illumination intensity using the LIO Intensity up/down buttons.
WARNING!
Verify that all personnel are wearing protective eyewear (OD 4 or above at 532 nm)
as soon as the system is in Standby/Ready mode, as well as during treatment.
NOTE: It is not recommended to use exposure times longer than two seconds
in CW (Continuous Wave) mode. Depending on the thermal load,
the system may shut down prior to the footswitch being released. A
message will appear on the display indicating this condition.
8. Select the aiming beam intensity by pressing the Aiming Beam up/down
buttons.
WARNING!
Do not attempt treatment if aiming beam is not present. Patient injury may occur.
9. Set the desired treatment power by pressing the Power up/down buttons.
10. Select the laser spot size using the Laser Spot Size lever (see Figure 6-4). The
positions of the Laser Spot Size lever for large (approximately 1 mm) and small
(approximately 0.5 mm) laser spot sizes are marked with large and small black
dots on the right side of the box, respectively. The change of laser spot size from
large to small results in approximately four times increase in irradiance within
the treatment area, provided that laser power was not adjusted.
It is recommended to adjust laser power each time the Laser Spot Size Control
setting is changed. Start with low power and a short duration pulse, then
increase until the desired coagulation result is achieved.
WARNING!
If unsure which settings are required, select a low power, short duration, and large
laser spot size. Failure to properly adjust delivered energy may lead to patient injury.
NOTE: The aiming beam is off during treatment beam exposure, except in
repeat mode.
14. Repeat the firing procedure as often as necessary, making adjustments to power
output and duration as appropriate to complete the treatment session.
15. When the treatment is completed, release the footswitch and press the Standby
button on the touchscreen.
NOTE: The Emergency switch on the front panel must only be used in case of
emergency. After using the Emergency switch, return it to its initial
position to restore power and start the instrument.
Any damaged hardware must be replaced. Contact your Alcon Technical Service
representative.
CAUTION
Care and cleaning operations must be performed with the instrument turned off and
power disconnected.
WARNING!
The bulb and bulb connector may be hot, and can burn your fingers.
CAUTION
Do not touch the glass part of the new bulb directly with your fingers. Oil from fingers
can dramatically reduce bulb life.
4. Clean the new bulb with a soft, clean cloth.
5. Insert the new bulb so its locating pin engages in the housing slit.
6. Rest the bulb connector on the base of the bulb and firmly screw it in.
7. Re-connect the cord socket.
The PurePoint™ LIO must be installed by an Alcon trained representative for power
output verification prior to the initial use. To schedule installation, contact the Alcon
Technical Services Department at 800-832-7827. Outside the USA, contact your local
Alcon Affiliate.
Insure that the selection on the Constellation™ Vision System display is LIO. It is the
responsibility of the operator to verify that the selection is correctly confirmed.
The operator must be careful to avoid potential secondary reflections; therefore, the
room used to treat the patient should be approved by a qualified laser safety officer.
All personnel in the treatment room must wear protective eye wear (OD 4 or above at 532
nm) when the system is in Standby, Ready, or Firing modes.
The laser delivery system is an integral part of the LIO and is not designed to be used
with an observer. Never use a teaching or observation system in conjunction with the
LIO. There is no eye protection provided for the observer.
Never treat a patient when the PurePoint™ Laser is connected to a service computer.
Before each use of the headset, the operator must check the permanent Doctor
Protection Filter for scratches, breaks, or alterations. If there is any doubt, please call
Alcon Technical Services, and discontinue use of device.
There are potential hazards when inserting, steeply bending, or improperly handling the
fiber optic cable. Not following the recommendations of the manufacturer may lead to
damage to the fiber or delivery system and/or harm to the patient or user.
Since the aiming beam passes down the same delivery system as the treatment beam,
it provides a good method of checking the integrity of the delivery system. If the aiming
beam spot is not present at the distal end of the delivery system, or its intensity is
reduced or it looks diffused, this a possible indication of a damaged or not properly
working delivery system. If there is any doubt, contact Alcon Technical Services.
The use of flammable anesthetics or oxidizing gases such as nitrous oxide (N2O) and
oxygen should be avoided. Some materials - for example cotton wool when saturated
with oxygen - may be ignited by the high temperatures produced in normal use of the
laser equipment. The solvents of adhesives and flammable solutions used for cleaning
and disinfecting should be allowed to evaporate before the laser equipment is used.
There is also danger of ignition of endogenous gases.
A qualified technician must verify LIO performance every twelve months to ensure the
LIO is operating within specifications. See Section Four of this operator’s manual for
instructions on verifying and calibrating the system. If the LIO is not operating within
specifications, do not use the system; call Alcon Technical Services.
This device must only be used by clinicians trained in the use of ophthalmic laser
devices.
This device is designed for safe use with a laser of 532 nm wavelength. Check the
markings on the top of the LIO (near the optical fiber connection) and ensure they match
those on the connected Laser.
Always look through the ophthalmoscope when the treatment beam is activated. Do not
look over the ophthalmoscope when the treatment beam is activated.
Do not disassemble or modify the battery. There are no serviceable parts inside.
Do not use a battery that is deformed, leaking, corroded or visually damaged. Handle
a damaged or leaking battery with care. If you come into contact with electrolyte,
wash exposed area with soap and water. If it contacts the eye, seek medical attention
immediately.
Use only Alcon supplied batteries, chargers and power supplies as per the accessories
listed.
When replacing lithium battery pack, turn illumination power off and attach new pack.
Remove batteries when device may not be used for prolonged periods.
Do not charge battery in any environment where the temperature may exceed 40˚C or fall
below 0˚C.
Ensure device is securely held in docking station to minimize risk of injury or damage to
equipment.
The LIO is intended to be used with the LIO LED only. Any other light source used with
the LIO will not function.
The LIO is intended to be used with the LIO docking station only.
No other equipment apart from the LIO and spare battery should be mounted onto the
charging dock when fixed to the wall to prevent the likelihood of the charging dock from
falling.
Switch off the electrical supply and disconnect from the mains electrical supply before
cleaning and inspection.
Do not fit mains power adapter into a damaged mains outlet socket.
Route charger power cords and fiber optic cable safely to eliminate risk of tripping or
damage to equipment.
LED’s can reach high temperatures in use – allow to cool before handling.
Maintenance, care, and cleaning must be performed with the instrument turned off and
power disconnected.
To minimize hazardous light exposure, operate light source at lowest intensity setting
consistent with adequate visibility of the surgical area.
The light emitted from this instrument is potentially hazardous. The longer the duration
of exposure, the greater the risk of ocular damage. Exposure to light from this instrument
when operated at maximum intensity will exceed the safety guideline after 60 minutes
using a ancillary 20D lens.
CAUTION
The light emitted from this instrument is potentially hazardous. The longer the
duration of exposure, the greater the risk of ocular damage. Exposure to light from this
instrument when operated at maximum intensity will exceed the safety guideline after
60 minutes using a ancillary 20D lens.
Date of Manufacture
Manufacturer
Headband Height Adjustment Knob
Headband Circumference
Adjustment Knob
Brow Band
Tension Knob (2)
Observation Optics
Adjustment Knob Aperture
Lever
Filter
Selection
Lever
Illumination LED
Under some single fault conditions the
temperature of the surface shown below
could get hot and there is a possible risk of
a burn if touched.
Aperture Lever
• Large - This large, round, uniform patch is suitable for routine examinations
through fully dilated pupils. In this position the mirror remains in the
forward position and the optics are diverged.
• Intermediate - The intermediate patch is designed to reduce reflections
when entering a partially or poorly dilated pupil (3 mm). It is also ideal for
close inspection of particular fundal areas. The mirror and optics stay in the
mid position.
• Small - This light patch is ideal for small, undilated pupils. The mirror
moves back and the optics automatically converge.
White Circle - Clear light; select the clear with no filter when inspecting a
specific pathology and a brighter, whiter light is desired.
Green Circle - Red free filter; this filter reduces the red light so blood will appear
black, silhouetted against a dark background.
Diffuser - This unique extra wide beam of diffused light permits a more relaxed
technique during more challenging fundus examinations. When using this filter,
the alignment between the headset, the condensing lens, and the pupil, in order to
achieve a full lens image, is not as critical as with the conventional beam.
Charging Spare
Battery LED
Charging Battery
on LIO Headband
LIO Headband
Charging Dock
Figure 6-15 Reference Diagram for Mounting the Battery Charging Station
3. Replace the power supply blanking plate with the appropriate mains plug
adaptor (if required). Plug the power supply into an appropriate mains plug and
connect it to the charging station.
The battery attached to the LIO headset will take approximately 2 hours to fully
charge and will last approximately 2 hours on the full power setting. The spare
battery will take approximately 4 hours to charge.
Power
Supply
Connector
Release Button
Figure 6-17 Removing and Replacing the Battery on the LIO Headset
2. Place the LIO on your head and adjust the circumference and height using the
Circumference and Height Adjustment Knobs so that the headband is firmly
positioned but fits comfortably on the head (see Figure 6-18).
3. For convenience, use clothing clip to attach the fiber/cable assembly to clothing.
4. Ophthalmoscope Angle Alignment
4.1 For vertical alignment of the eyepieces and binocular block, adjust the
height of the Metal Outer Brow Bar if necessary by using the Brow Band
Tension Knobs located on each side of the headset.
4.2 Position the Binocular Block as close to the eyes or spectacles as possible
for maximum field of view and tighten the Observation Optics Adjustment
Knob.
WARNING!
To minimize hazardous light exposure, operate light source at lowest intensity
setting consistent with adequate visibility of the surgical area.
WARNING!
All the personnel in the room during the operation must wear protective safety
eye wear with a minimum optical density OD 4 to filter 532 nm radiation.
Before each use of the headset, the operator must examine the permanent Doctor
Protection Filter for scratches, breaks, or alterations by looking through the
ocular lens. If there is any doubt, discontinue use of device and please call Alcon
Technical Service.
NOTE: The PurePoint™ LIO is shipped with +2 diopter ocular lenses installed. These
may be changed with 0 (zero) diopter lenses.
12. If desired, change the ocular lenses by unscrewing the eyecup retainers in the
counterclockwise direction, change each lens, and replace the eyecup retainers.
Ensure that the new lenses are clean; i.e., no fingerprints or debris. Refer to the
PurePoint™ LIO maintenance section for cleaning instructions.
13. Turn the Constellation™ Vision System console power ON and make the
appropriate selections as specified in this manual.
14. Turn LIO Illumination ON.
15. Select the appropriate illumination field size using the Aperture lever.
16. Adjust the illumination intensity using the Illumination Intensity Adjustment
knob.
17. On the touchscreen, set the power below the nominal titration level.
18. If necessary, press the Reset button to reset the shot counter to 0.
19. Select exposure time by pressing the Exposure Time Adjustment arrow buttons.
WARNING!
Verify that all personnel are wearing protective eye wear (OD 4 or above at
532 nm) as soon as the system is in Standby/Ready mode, as well as during
treatment.
NOTE: It is not recommended to use exposure times longer than two seconds in
CW (Continuous Wave) mode. Depending on the thermal load, the system may
shut down prior to the footswitch being released. A message will appear on the
display indicating this condition.
20. Select the aiming beam intensity by pressing the Aiming Beam up/down
buttons.
WARNING!
Do not attempt treatment if aiming beam is not present. Patient injury may occur.
NOTE: The aiming beam is off during treatment beam exposure, except in
repeat mode.
25. Repeat the firing procedure as often as necessary, making adjustments to power
output and duration as appropriate to complete the treatment session.
26. When the treatment is complete, release the footswitch and press the Standby
button on the touchscreen.
Turn Off Sequence
27. Turn the key to the OFF (O) position and, for safety reasons, remove the key.
NOTE: The Emergency switch on the front panel must only be used in case
of emergency. After using the Emergency switch, pull it back to its initial
position to restore power and start the instrument.
28. Place the Illumination On/Off switch to the OFF (O) position.
Storage
The PurePoint™ LIO should be stored either on the Charging Station or in a storage
case when not in use to prevent inadvertent damage to the headset or fiber optic cable.
WARNING!
The LED may get hot during prolonged use.
Illumination LED
Red switch in
forward position
POWER VERIFICATION
Alcon recommends that a power verification be performed on an annual basis as an integral
part of the laser system with which it is used. Refer to Section Four of this manual for system
calibration information.
Symbols D
3D SUBMODE........................................................................ 2.90 Detailed Setup........................................................................ 2.74
(Hold) Duration....................................................................... 2.36 DFU.......................................................................................... 4.3
% Time On............................................................................ 2.119 diagnostics............................................................................... 3.1
Diathermy/Coagulation Handpieces..................................... 2.166
A
Diathermy Global Control....................................................... 2.64
Diathermy Power.................................................................... 1.25
Directions For Use (DFU)......................................................... 4.3
About Constellation™............................................................. 2.50 display panel................................................................... 2.1, 2.14
ABS™................................................................................... 2.162 display screens....................................................................... 2.14
Accessories Setup Panel....................................................... 2.71 DISPOSAL OF XENON LAMPS............................................... 4.4
Accessory Equipment............................................................. 1.10 Doctor Protection Filter........................................................... 1.35
Accurus™ Classic.................................................................. 2.85 DOCTOR SETTINGS............................................................. 2.22
AcrySof™ intraocular lenses................................................ 2.166 drainage bag........................................................................ 2.168
Add Favorite........................................................................... 2.19 DVD/CD.................................................................................. 2.46
Add to Procedure................................................................... 2.19 DVD/RW................................................................................... 2.7
Advisory Messages........................................................... 5.3, 5.4 Dynamic Rise....................................................................... 2.103
Aiming Beam On During Standby Mode................................ 2.36
Air Pressure Requirements.................................................... 1.10
Aspiration Bypass System.................................................... 2.162
Audio Input........................................................................ 2.7, 2.8
E
AUTO GAS FILL............................................................ 2.44, 2.80 eConnectivity.......................................................................... 2.39
Auto Gas Filling...................................................................... 2.71 Electrical Connectors............................................................... 2.1
Auto Gas Fill Purge Cycles.................................................... 2.38 electrical interconnections........................................................ 2.7
AutoSert™ IOL Injector........................................................ 2.166 Electromagnetic Emissions.................................................... 1.12
Auxiliary Illuminator Module Eject Button................................. 2.9 Electromagnetic Immunity...................................................... 1.13
EMC Statement...................................................................... 1.12
B
End Case................................................................................ 2.57
END CASE........................................................................... 2.150
Endoprobe Power Verification.................................................. 4.6
Barcode Reader....................................................................... 2.7 Energy Matrix........................................................................... 4.8
Barcode scanner connection............................................. 2.7, 2.8 Environmental Limitations........................................................ 1.4
Basic Setup............................................................................ 2.66 Equipotential Ground Connector.............................................. 2.9
batteries are installed............................................................. 2.13 error message........................................................................ 1.17
Bimanual mode...................................................................... 2.88 Event Log............................................................................... 2.49
biohazards................................................................... 1.23, 2.169 Exposure Time Verification....................................................... 4.6
Bottle Hanger........................................................................... 2.2 EXTRACT SUBMODE.......................................................... 2.147
Bubble Suppression Insert................................................... 2.163 EXTRAS................................................................................. 2.43
BURST SUBMODE................................................... 2.110, 2.112 EXTRUSION MODE............................................................. 2.133
buttons.................................................................................... 2.14
C F
Facility Pressure Source Connectors....................................... 2.8
CALIBRATION VERIFICATION................................................ 4.4 Fault Messages........................................................................ 5.2
CARE AND CLEANING............................................................ 4.1 FCC Compliance Statement................................................... 1.14
care and maintenance.............................................................. 4.1 Field Service........................................................................... 2.43
CASSETTE.......................................................................... 2.168 Fill Progress........................................................................... 2.44
caster wheels........................................................................... 2.4 FIXED SUBMODE................................................................ 2.125
Cautions..................................................................................... ix Fluid/Air Exchange (F/AX) Global Control............................. 2.62
CD/DVD.................................................................................. 2.46 Fluidic Management System.................................................... 2.1
Circulating Nurse...................................................................... 3.1 fluidics module.......................................................................... 2.1
Clean Cassette....................................................................... 2.43 Fluidics Module........................................................................ 2.1
cleaning.................................................................................... 4.1 Fluidics Setup Panel............................................................... 2.67
cleaning and sterilization instructions....................................... 4.3 footswitch........................................................................ 2.2, 2.10
Coagulation Handpieces...................................................... 2.166 Footswitch..................................................................... 2.28, 2.30
Composite Video In/Out.................................................... 2.7, 2.8 Footswitch Button Actions...................................................... 2.31
Configure Printer.................................................................... 2.38 footswitch cable connector....................................................... 3.2
CONNECTING A PUREPOINT LASER.................................. 3.11 Footswitch Configuration........................................................ 2.35
Connectors............................................................................... 2.1 Footswitch Storage Hook......................................................... 2.2
connectors and outlets............................................................. 2.7 Force English......................................................................... 2.41
Consumables................................................................ 2.45, 2.79 Forceps.................................................................................. 2.71
Continuous........................................................................... 2.122 FORCEPS MODE................................................................ 2.142
CONTINUOUS SUBMODE...... 2.107, 2.109, 2.120, 2.122, 2.123 Fragmatome™* handpiece.................................................. 2.160
Contra Indications.................................................................. 1.36 Fragmentation Handpiece.................................................... 2.160
Copying data.......................................................................... 2.48 FRAGMENTATION MODE................................................... 2.123
Creating New Tables............................................................ 2.153 front display panel.................................................................. 2.14
Customer Service................................................................... 1.24 Front Display Panel.................................................................. 2.1
Custom Procedure................................................................. 2.86 FRONT PANEL......................................................................... 2.1
CUSTOM SUBMODE................................................ 2.113, 2.115
H
LIO Maintenance........................................................... 6.19, 6.38
LIO Power Verification.............................................................. 4.6
LIO Safety Features...................................................... 6.14, 6.27
handpieces and probes........................................................ 2.159 LIO Technical Specifications................................................... 6.13
Handpiece Setup Panel.......................................................... 2.69 Load Plunger button.................................................. 2.135, 2.136
Help........................................................................................ 2.53 logo screen............................................................................... 3.1
Hi-Def Margin......................................................................... 2.41 Longitudinal Pulse Duration................................................. 2.106
High Definition Video Overlay................................................. 2.41 Longitudinal / Torsional Ratio............................................... 2.106
horizontal/vertical switches..................................................... 2.10
I M
Mackool** U/S Tips............................................................... 2.162
I/A handpiece........................................................................ 2.164 Main Power Switch................................................................... 2.9
IEC Standard.......................................................................... 1.10 Main Screen........................................................................... 2.15
Illumination............................................................................... 2.4 Manual Revision Record............................................................. iii
ILLUMINATOR........................................................................ 1.29 Menu Bar................................................................................ 2.16
Illuminator Global Control....................................................... 2.65 Metrics.................................................................................. 2.151
Illuminator Module Eject Button................................................ 2.9 MicroSmooth™* Infusion Sleeves........................................ 2.163
Indications for Use.................................................................... 1.2 Modify Procedure................................................................... 2.19
Industry of Canada (IC).......................................................... 1.15 MOMENTARY SUBMODE.......................................... 2.93, 2.129
Infiniti™ Ultrasonic (U/S) Handpiece.................................... 2.161 Monitor Type........................................................................... 2.40
Information Messages.............................................................. 5.5 moving the instrument.............................................................. 2.4
Infusion sleeves.................................................................... 2.163 MP3................................................................................... 2.7, 2.8
Infusion Sleeves................................................................... 2.163 MULTICUT SUBMODE........................................................ 2.143
Initial Rate............................................................................ 2.135 multi media card (MMC)........................................................... 2.1
INITIAL SYSTEM SETUP......................................................... 3.2 Multiple Cut or MPC submode............................................. 2.143
Inject..................................................................................... 2.148
Injector.................................................................................. 2.166
INJECT SUBMODE.............................................................. 2.148
installation.............................................................................. 1.10
N
Installation.............................................................................. 1.10 N2........................................................................................... 1.10
instrument tray.......................................................................... 2.2 Navigation.............................................................................. 2.57
Instrument Tray........................................................................ 2.2 Network Connection............................................................... 2.38
intraocular lenses................................................................. 2.166 NGENUITY*.......... 1.2, 2.7, 3.16, 2.30, 2.41, 2.53, 2.53–2.56, 2.8
INTREPID™ AutoSert™ IOL Injector................................... 2.166 NGENUITY* 3D Visualization................................................. 2.38
IOL Injector.................................................................. 1.20, 2.166 NGENUITY * Auxiliary............................................................ 2.30
IP Settings dialog.................................................................. 2.105 NGENUITY* Image Orientation.............................................. 2.30
IRRIGATION/ASPIRATION (I/A) MODE............................... 2.131 NGENUITY* Margin............................................................... 2.41
Irrigation Global Control......................................................... 2.63 NGENUITY* Menu................................................................. 2.30
IV Pole...................................................................................... 2.2 NGENUITY* Setup Screen..................................................... 2.54
IV pole extender....................................................................... 2.2 Nurse........................................................................................ 3.1
J O
No entries Operator Profile.......................................................................... ix
O-ring tool............................................................................. 2.165
K
Ozil™.................................................................................... 2.104
OZIL™ BURST..................................................................... 2.112
OZIL™ CUSTOM PULSE..................................................... 2.115
key tone.................................................................................. 2.14 OZil™/Phaco Sequence......................................................... 2.28
OZIL™ PULSE..................................................................... 2.119
T
PUREPOINT™ LASER SAFETY FEATURES....................... 1.33
Push Prime............................................................................. 2.78
R
Timer...................................................................................... 2.81
timing configurations............................................................ 2.105
Tips....................................................................................... 2.162
Radio Frequency Identification (RFID)................................... 1.14 Toggle Video Recording................................................ 2.30, 2.41
Ramping................................................................................. 2.33 tone........................................................................................ 2.14
REAR PANEL........................................................................... 2.5 touch screen........................................................................... 2.14
Recover.................................................................................... 5.3 Touchscreen........................................................................... 2.14
Recovery Training.................................................................. 2.51 Touch Screen........................................................................... 2.1
Remote Battery Low............................................................... 2.13 Transparent Text..................................................................... 2.40
REMOTE CONTROL.............................................................. 2.11 treadle.................................................................................... 2.10
Remote Control Batteries....................................................... 2.13 Treatment Hazards................................................................. 1.36
REMOTE CONTROL BATTERIES........................................... 4.4 TROUBLESHOOTING GUIDE............................................... 5.11
Remote Control Channel........................................................ 2.13 TurboSonics™...................................................................... 2.162
Remote Control Settings........................................................ 2.39 TurboSonics™ Tips.............................................................. 2.162
Remote Control Settings dialog.............................................. 2.13
Retract.................................................................................. 2.135
Retract button............................................................ 2.135, 2.136
Revert to Standby Timeout..................................................... 2.36
U
Ultraflow™* handpiece......................................................... 2.164
S
Ultraflow™* Handpieces and Tips........................................ 2.164
Ultraflow™* I/A handpiece.................................................... 2.164
uncrating.......................................................................... 1.10, 4.4
Scissors.................................................................................. 2.71 Universal Precautions............................................................ 1.12
Scissors mode...................................................................... 2.143 USB Connector................................................................. 2.7, 2.8
SCISSORS MODE............................................................... 2.143 User Manual........................................................................... 2.51
Screen Brightness.................................................................. 2.37 U/S) Handpiece.................................................................... 2.161
Scrub Nurse............................................................................. 3.1 U/S tips................................................................................. 2.162
SD-Card................................................................................. 2.46 Utility Requirements............................................................... 1.32
self-test..................................................................................... 2.1
self-test diagnostics.................................................................. 3.1
servicing issues........................................................................ 4.1
Settings Restoration............................................................... 1.10
V
Setup...................................................................................... 2.66 Vacuum mode vs. Flow mode................................................ 2.88
Setup Form........................................................................... 2.151 VFC mode............................................................................ 2.147
Setup screen.......................................................................... 2.14 VGA out.................................................................................... 2.8
silicone oil............................................................................. 2.147 Video Broadcast..................................................................... 2.40
sleeves................................................................................. 2.163 Video Connection.......................................................... 2.40, 2.41
Smart Pulse.......................................................................... 2.104 Video Overlay.................................................................. 2.8, 2.41
SOUND SETTINGS................................................................ 2.36 Video Overlay Connection............................................. 3.15, 3.16
source air pressure................................................................. 1.10 Video Overlay setting.................................................... 2.40, 2.41
SPECIAL TOOLS..................................................................... 4.5 Video Recorder.............................................................. 2.41, 3.14
SPECIFICATIONS.................................................................... 1.4 View All................................................................................... 2.19
Spectral Output...................................................................... 1.29 View/Copy/Delete................................................................... 2.46
STANDARD DEFINITION VIDEO OVERLAY......................... 2.40 View Favorites........................................................................ 2.19
Standard vs. Advanced mode................................................ 2.88 Viscous Fluid Control.............................................................. 2.71
Standby Power Switch............................................................. 2.9 VISCOUS FLUID CONTROL (VFC) MODE......................... 2.147
Standby switch......................................................................... 3.1 VIT: Proportional Vacuum submode....................................... 2.93
Start Prime............................................................................. 2.78 Vitrectomy Mode............................... 2.90, 2.93, 2.96, 2.99, 2.101
Startup Screen....................................................................... 2.14 Vitrectomy Probes................................................................ 2.159
Status Setup panel................................................................. 2.74
Step Filtering.......................................................................... 2.19
W
Warnings.................................................................................... ix
WARRANTY........................................................................... 1.28
WETANT SUBMODE.................................................. 2.99, 2.101
Wireless LAN device.............................................................. 1.14
X
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Y
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Z
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