Alcon LenSx 8065998162 LenSx Laser User Manual

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LENSX LASER SYSTEM
OPERATOR’S MANUAL
Alcon LenSx, Inc.
33 Journey
Aliso Viejo, CA 92656
Date of Issue: January 2011
Alcon Laboratories, Inc.
Distrubuted By: 6201 South Freeway
Fort Worth, TX 76134‐2099
Alcon Laboratories, UK Ltd.
Pentagon Park, Boundary Way
Hemel Hempstead
Hertfordshire, HP2 7UD, UK
DRAFT
0086
LENSX LASER SYSTEM
OPERATOR’S MANUAL
LenSx Laser System
Operator’s Manual
The information contained in this document is the confidential and proprietary property of Alcon LenSx, Inc.
(LenSx). Any reproduction, dissemination, or distribution of this document in whole or in part without prior
written permission of LenSx is strictly prohibited. While every effort has been made to ensure the accuracy
of information provided in this document, please note that the information, figures, illustrations, tables,
specifications, and schematics contained herein are subject to change without notice.
Please direct all inquiries regarding this manual or for service assistance to Alcon LenSx, Inc., 33 Journey,
Aliso Viejo, California 92656. Telephone (949) 360‐6010 (in the United States)
LenSx and the LenSx logo are registered trademarks of Alcon LenSx Inc. ©2011 LenSx Lasers, Inc. All rights
reserved. No portion of this manual may be reproduced or transmitted in any form or by any means
without the express prior written consent of LenSx.
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Table of Contents
TABLE OF CONTENTS ............................................................................................................................ 0
LENSX LASER SYSTEM .................................................................................................................. 3
1.1
INDICATIONS FOR USE ....................................................................................................................... 3
1.2
SUMMARY DESCRIPTION ................................................................................................................... 3
1.3
CONTRAINDICATIONS ........................................................................................................................ 3
1.4
COMPLICATIONS .............................................................................................................................. 4
GENERAL WARNINGS AND PRECAUTIONS .................................................................................... 6
2.1
WARNINGS ..................................................................................................................................... 6
2.1.1 Unauthorized Use of the Laser ................................................................................................ 7
2.1.2 Electrical .................................................................................................................................. 7
2.1.3 Eye Safety and Nominal Optical Hazard Distance ................................................................... 7
2.1.4 Mechanical/Motion ................................................................................................................. 8
2.1.5 Combustion/Fire ...................................................................................................................... 8
2.1.6 Environmental/Chemical ......................................................................................................... 8
2.1.7 Sterilization/Biological Contamination ................................................................................... 9
2.1.8 Emergency Off ......................................................................................................................... 9
2.2
PRECAUTIONS .................................................................................................................................. 9
2.2.1 General .................................................................................................................................... 9
2.2.2 Patient Selection...................................................................................................................... 9
2.2.3 Surgical Procedure................................................................................................................... 9
2.2.4 Power Failure or Emergency Off.............................................................................................. 9
2.3
SAFETY FEATURES .......................................................................................................................... 10
2.3.1 Key Switch ............................................................................................................................. 10
2.3.2 Laser Enabling ....................................................................................................................... 10
2.3.3 Laser Emission Indicator ........................................................................................................ 10
2.3.4 Protective Housing and Safety Interlock ............................................................................... 10
2.3.5 Labels..................................................................................................................................... 10
2.3.6 Safety Shutter Monitor .......................................................................................................... 11
2.3.7 Footswitch Control ................................................................................................................ 11
2.3.8 Remote Interlock Connector .................................................................................................. 11
2.3.9 Emergency OFF Switch .......................................................................................................... 11
2.3.10
Laser Cooling System ........................................................................................................ 11
2.3.11
Manual Gantry Lift ............................................................................................................ 12
2.3.12
Patient Interface RFID ....................................................................................................... 12
2.3.13
Console Footbrake ............................................................................................................ 12
2.4
DEVICE ELECTRICAL CLASSIFICATION .................................................................................................. 12
SYSTEM DESCRIPTION ................................................................................................................ 13
3.1
INTRODUCTION .............................................................................................................................. 13
3.2
SYSTEM OVERVIEW ........................................................................................................................ 13
3.2.1 Femtosecond Laser Engine .................................................................................................... 15
3.2.2 Energy Monitor...................................................................................................................... 15
3.2.3 Delivery System ..................................................................................................................... 15
3.2.4 Video Microscope .................................................................................................................. 15
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3.2.5 Optical Coherence Tomography (OCT) imaging device ......................................................... 16
3.2.6 Patient Interface .................................................................................................................... 16
3.2.7 Surgeon Controls ................................................................................................................... 17
3.2.8 System Electronics ................................................................................................................. 17
3.2.9 Console Chassis ..................................................................................................................... 18
3.3
PROCEDURE OVERVIEW................................................................................................................... 18
3.3.1 Pre‐Operative ........................................................................................................................ 19
3.3.2 Anterior Capsulotomy ........................................................................................................... 19
3.3.3 Phacofragmentation ............................................................................................................. 20
3.3.4 Combined Treatments ........................................................................................................... 20
3.3.5 Post‐Operative....................................................................................................................... 20
CONTROLS, INDICATORS AND DISPLAYS .................................................................................... 21
4.1
DISPLAY PANEL & KEYBOARD ........................................................................................................... 21
4.2
SURGICAL DISPLAY ......................................................................................................................... 21
4.2.1 Video Microscope .................................................................................................................. 21
4.2.2 Optical Coherence Tomography (OCT) Device ...................................................................... 21
4.3
DELIVERY SYSTEM PANEL................................................................................................................. 22
4.3.1 Joystick .................................................................................................................................. 22
4.3.2 Delivery System Touch Screen ............................................................................................... 22
4.3.3 Applanation Indicator............................................................................................................ 22
4.3.4 Illumination and Microscope Focus ....................................................................................... 22
4.3.5 Fixation Light ......................................................................................................................... 23
4.4
SYSTEM POWER ............................................................................................................................. 23
4.4.1 Main Input Switch ................................................................................................................. 23
4.4.2 Key Switch ............................................................................................................................. 23
4.4.3 Emergency off switch ............................................................................................................ 23
4.5
FOOTSWITCH ................................................................................................................................. 23
4.6
SOFTWARE CONTROLS .................................................................................................................... 23
4.6.1 System Startup ...................................................................................................................... 23
4.6.2 Procedure Programming Window ......................................................................................... 24
4.6.3 System Checks ....................................................................................................................... 24
4.6.4 User Registration ................................................................................................................... 24
4.6.5 Shutdown .............................................................................................................................. 24
4.6.6 About ..................................................................................................................................... 24
4.7
ACCESSORIES & DETACHABLE PARTS ................................................................................................. 25
SYSTEM REQUIREMENTS............................................................................................................ 26
5.1
ELECTRICAL ................................................................................................................................... 26
5.2
ENVIRONMENTAL ........................................................................................................................... 26
PROCEDURE GUIDE .................................................................................................................... 27
6.1
PREPARATION AND TREATMENT PLANNING ........................................................................................ 27
6.2
START UP & PROCEDURE SELECTION ................................................................................................. 27
6.2.1 Programming the Lens Pattern ............................................................................................. 31
6.2.2 Programming the Capsulotomy Pattern ............................................................................... 32
6.2.3 Programming the Primary Incision Pattern........................................................................... 32
6.2.4 Programming the Secondary Incision Pattern....................................................................... 33
6.2.5 Programming the Arcuate Incision Patterns ......................................................................... 34
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6.2.6 Combining Patterns ............................................................................................................... 35
6.2.7 Completing Pattern Selection ................................................................................................ 36
6.3
PREPARING THE PATIENT INTERFACE ................................................................................................. 37
6.4
DOCKING ...................................................................................................................................... 38
6.5
PATTERN POSITIONING.................................................................................................................... 40
6.5.1 Overview................................................................................................................................ 40
6.5.2 Video Microscope, OCT Image Guides and Pattern Graphics ............................................... 41
6.5.3 Limbus Centration ................................................................................................................. 41
6.5.4 Primary and Secondary Incision Alignment ........................................................................... 42
6.5.5 Lens Alignment ...................................................................................................................... 43
6.5.6 Capsule Depth Adjustment .................................................................................................... 44
6.5.7 Lens Depth Adjustment ......................................................................................................... 47
6.5.8 Corneal Primary and Secondary Incisions Thickness Adjustment ......................................... 49
6.5.9 Arcuate Incision Thickness Adjustments ............................................................................... 51
6.6
CONFIRMATION ............................................................................................................................. 52
6.7
TREATMENT .................................................................................................................................. 53
6.8
PROCEDURE COMPLETION ............................................................................................................... 55
CALIBRATION AND ALIGNMENT ................................................................................................. 56
7.1
ENERGY CALIBRATION ..................................................................................................................... 56
7.2
BEAM STEERING ............................................................................................................................ 56
SERVICE AND MAINTENANCE ..................................................................................................... 57
8.1
TRANSPORT AND STORAGE .............................................................................................................. 57
TROUBLE SHOOTING .................................................................................................................. 58
10
LABELS ....................................................................................................................................... 60
10.1
CONSOLE LABELS ........................................................................................................................... 60
11
SYSTEM SPECIFICATIONS ........................................................................................................... 63
12
WARRANTY INFORMATION ....................................................................................................... 64
13
ABBREVIATIONS AND TERMS ..................................................................................................... 65
13.1
GENERAL ABBREVIATIONS................................................................................................................ 65
13.2
TERMS ......................................................................................................................................... 65
14
NOMINAL OPTICAL HAZARD DISTANCE (NOHD) ......................................................................... 66
15
DECLARATION OF COMPLIANCE ................................................................................................. 69
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LENSX LASER SYSTEM
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1 LenSx Laser System
1.1 Indications for Use
The LenSx Laser is indicated for use in patients undergoing cataract surgery for removal of the
crystalline lens. Intended uses in cataract surgery include anterior capsulotomy,
phacofragmentation, and the creation of single plane and multi‐plane arc cuts/incisions in the
cornea, each of which may be performed either individually or consecutively during the same
procedure.
1.2 Summary Description
The LenSx Laser creates incisions through tightly focused femtosecond laser pulses that cut
tissue with micron‐scale precision. The incision is achieved by contiguously placed micro‐
photodisruptions scanned by a computer‐controlled delivery system. The LenSx Laser System
should only be operated by a physician trained in its use.
The LenSx Laser delivery system employs one sterile disposable LenSx Laser Patient Interface
consisting of an applanation lens and suction ring. The Patient Interface is intended for single‐
use, only. Refer to the Instruction for Use supplied with the LenSx Laser Patient Interface for
preparation and application instructions for the patient interface.
The physician should base patient selection criteria on professional experience, published
literature, and educational courses. Adult patients should be scheduled to undergo cataract
extraction.
1.3 Contraindications
Contraindications for the anterior capsulotomy, phacofragmentation of the lens using the LenSx
Laser include the following:






Corneal disease that precludes applanation of the cornea or transmission of laser light
at 1030 nm wavelength
Descemetocele with impending corneal rupture
Corneal opacity that would interfere with the laser beam
Presence of blood or other material in the anterior chamber
Hypotony, glaucoma, or the presence of a corneal implant
Poorly dilating pupil, such that the iris is not peripheral to the intended diameter for the
capsulotomy
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




Conditions which would cause inadequate clearance between the intended capsulotomy
depth and the endothelium (applicable to capsulotomy only)
Residual, recurrent, active ocular or eyelid disease, including any corneal abnormality
(for example, recurrent corneal erosion, severe basement membrane disease)
A history of lens or zonular instability
Any contraindications to cataract or keratoplasty surgery
This device is not intended for use in pediatric surgery.
Contraindications for corneal incisions using the LenSx Laser include the following:






Previous corneal incisions that might provide a potential space into which the gas
produced by the procedure can escape
Corneal thickness requirements that are beyond the range of the system
Corneal opacity that would interfere with the laser beam
Hypotony, glaucoma, or the presence of a corneal implant
Residual, recurrent, active ocular or eyelid disease, including any corneal abnormality
(for example, recurrent corneal erosion, severe basement membrane disease)
This device is not intended for use in pediatric surgery.
Potential contraindications are not limited to those included in this list.
1.4 Complications
Possible complications resulting from anterior capsulotomy, phacofragmentation, or creation of
a partial thickness or full‐thickness cut or incision include:









Capsulotomy, phacofragmentation, or cut or incision decentration
Interrupted capsulotomy, fragmentation, or corneal incision procedure
Capsular tear
Corneal abrasion or defect
Pain
Infection
Bleeding
Damage to intraocular structures
Anterior chamber fluid leakage, anterior chamber collapse
In the case of an incomplete or interrupted capsulotomy, the procedure may be immediately
repeated with a slightly larger diameter to complete the capsulotomy. In the case of an
incomplete or interrupted fragmentation or partial thickness or full‐thickness arc cut/incision,
the procedure can be repeated at a slightly different position using the centration feature.
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In the case of an incomplete or interrupted 360‐degree keratoplasty incision, the procedure
may be immediately repeated with a slightly larger diameter to the recipient and a resized
corneal donor button. In the case of an interrupted procedure during donor tissue preparation,
repeating the procedure at a larger diameter may not be recommended if the recipient cornea
has been already prepared at a original diameter. In this case, a new donor cornea may be
required.
Cataract removal should be performed after anterior capsulotomy with the LenSx Laser. In the
initial clinical protocol using the LenSx, cataract removal was begun within 30 minutes after the
laser procedure. In previous studies using the Nd:YAG laser to perform anterior capsulotomy,
anterior chamber inflammation and elevated intraocular pressure were noted when cataract
surgery was delayed from one hour to up to one day following laser treatment.1, 2 The Nd:YAG
laser requires 100 times more energy per pulse than femtosecond lasers to induce
photodisruption.
Potential complications are not limited to those included in this list. These complications may
be surgically or medically managed using currently accepted techniques for cataract or
keratoplasty procedures.
Woodward PM. Anterior Capsulotomy using a neodymium YAG laser.
Ann Ophthalmol: 16:534‐9, 1984.
Szweda E. Preoperative anterior capsulotomy using YAG laser in cataract extraction by the
envelop method. Klin Oczna: 93: 334‐6, 1991.
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2 Warnings and Precautions
2.1 Warnings
The LenSx Laser is indicated for use in patients undergoing cataract surgery for removal of the
crystalline lens. Intended uses in cataract surgery include anterior capsulotomy,
phacofragmentation, and the creation of single plane and multi‐plane arc cuts/incisions in the
cornea, each of which may be performed either individually or consecutively during the same
procedure.
United States Federal Law restricts this device to sale and use by or on the order of a physician
or licensed eye care practitioner. United States Federal Law restricts the use of this device to
practitioners who have been trained in the operation of this device.
The performance of surgical procedures, operation of controls, or any other adjustments other
than those specified herein may result in hazardous conditions for both patients and personnel.
While the risk of fire is extremely low, the LenSx Laser should not be operated in the presence
of flammable anesthetics, volatile substances, or oxygen flow lines.
WARNING: Do not use cell phones or pagers of any kind in the same room as the LenSx Laser.
The LenSx Laser complies with 47 CRF 15 Federal Communication Commission Rules for radio
frequency devices. Changes or modifications not expressly approved by Alcon LenSx Inc. can
void the operator’s authority to operate this radio frequency device.
Only trained LenSx representatives should perform unpacking, installation, and servicing of the
LenSx Laser. Covers are not to be removed by anyone other than LenSx personnel. Accidental
contact with the high voltage electrical circuits in the interior of the LenSx Laser console may
result in serious injury or death. Ocular exposure to collimated beams contained in the console
interior can produce retinal damage.
Surgical lasers must meet requirements established by the Food and Drug Administration (FDA)
Center for Devices and Radiological Health and international standards and regulations for
surgical lasers. Specific controls are required that prevent accidental exposure of laser energy
to the eye and skin from both direct and reflected laser beams. In addition, precautions must
be taken in the surgical area to prevent fire and electrical hazards. Improper use of the LenSx
Laser may result in patient corneal trauma, infection, complications, or mechanical trauma to
either patient or personnel. All warnings, labeling and instructions must be observed.
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2.1.1 Unauthorized Use of the Laser
When not in use, the master key should be removed from the LenSx Laser and kept in a secure
location to prevent use of the laser by unauthorized personnel. Once the console is switched
ON, password protection is required to access any laser functions.
2.1.2 Electrical
High voltage electrical circuits are accessible if the console panels are removed. Only trained
LenSx service representatives should attempt to open the console panels. Serious injury or
death may occur while contacting electrical circuits in the unit interior. Tools are required to
remove the console panels. Panels should not be removed by anyone other than LenSx service
personnel. While the LenSx Laser requires 120VAC, 60Hz, 10A electrical service, the system is
configurable for the following input voltages: 100VAC/12A, 120V/10A, 220‐240V/7A, and
50/60Hz. The line voltage should be tested prior to laser installation and must be within
specified limits for proper operation of the unit.
An interlock connection allows the use of safety interlock switches on the operating suite doors
that automatically place the laser in STANDBY mode when the suite door(s) is opened.
The area around the LenSx Laser and the footswitch should be kept dry. The laser should not
be operated if there is any leakage of water from the console. A LenSx service representative
should be contacted immediately.
If the unit power cord is frayed or otherwise damaged, do not use unit until cord has been
replaced.
A tripping hazard exists if the AC power cord is not protected from foot traffic. Care must be
taken to avoid accidental unplugging of the LenSx Laser during treatment.
2.1.3 Eye Safety and Nominal Optical Hazard Distance
The NOHD is defined according to American National Standards Institute Z136.1‐2007,
“American National Standard for Safe Use of Lasers”. The NOHD is computed in terms of the
Maximum Permissible Exposure (MPE) allowed onto the eye. For the LenSx Laser the NOHD
calculated using this standard is short due to the small pulse energies emitted by the laser. The
most conservative NOHD for a direct beam exposure from the LenSx Laser is 106 cm (See
Appendix 2). This means that only the patient operative eye will be exposed to laser radiation
exceeding the MPE.
The practical consequence is that operators and support personnel are not at risk of optical
radiation during normal and routine operation of the laser. Any service operation requiring the
removal of any covers or shields on the console will require eyewear of OD ≥ 5 at a wavelength
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of 1030 nm. Only authorized LenSx service representatives should attempt to remove console
covers or to service the LenSx Laser.
Standard laser safety protocol requires that a warning sign be placed on the door of the room
when the laser is in use, to warn personnel of laser usage in progress before they enter the
controlled area. The door should be closed during the operation of the laser.
Removing the console covers increases the risk of eye injury. Only trained LenSx service
representatives should remove the console covers or attempt servicing of the LenSx Laser.
An interlock connection allows the use of safety interlock switches on the operating suite
door(s) that automatically disables laser emission when the surgical suite door(s) is opened.
The Patient Interface disposable cannot be reused or re‐sterilized; the LenSx Laser will not be
operable with a previously used Patient Interface.
2.1.4 Mechanical/Motion
The LenSx Laser console is stable and mobile within an operating room. No significant tipping
or rolling hazard exists once the console is placed in the locked position for surgery. Only
trained personnel should move the console. If the console must be moved for any reason, a
LenSx service representative should be contacted.
When installed, a footbrake at the back of the unit prevents the console from rolling. The
footbrake must be engaged during treatment.
Removing the console covers is a potential mechanical hazard. This operation should be
performed only by trained LenSx service representatives.
After docking is complete, the user should not move the delivery system until patient is
disengaged from the system.
2.1.5 Combustion/Fire
Although the possibility of combustion is remote, flammable anesthetics should not be used
with the LenSx Laser. Oxygen lines and flammable materials should be kept clear of the
immediate area surrounding the laser aperture.
2.1.6 Environmental/Chemical
No hazardous gases or chemicals are used in the LenSx Laser.
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2.1.7 Sterilization/Biological Contamination
The LenSx Laser is used with the LenSx Laser Patient Interface. This sterile assembly cannot be
reused and should be disposed of as medical waste.
2.1.8 Emergency Off
In the event of an emergency, the LenSx Laser should be immediately shut down by pressing
the red emergency OFF button located at top center on the front panel.
If the LenSx Laser is shut down (by pressing the Emergency Off button or by a loss of power),
the patient may be removed from under the delivery system by lowering the bed or by
actuating the manual gantry lift located at the base of the delivery system gantry.
2.2 Precautions
2.2.1 General
The Patient Interface will increase intraocular pressure during the procedure. Care must be
taken to minimize applanation times. Incomplete applanation may result in non‐uniform or
incomplete incisions.
2.2.2 Patient Selection



Patients must be able to lie flat and motionless in a supine position.
Patient must be able to understand and give an informed consent.
Patients must be able to tolerate local or topical anesthesia. Patients with elevated IOP
should use topical steroids only under close medical supervision.
2.2.3 Surgical Procedure
Full thickness cuts or incisions should be performed with instruments and supplies on standby
to seal the eye in case of anterior chamber collapse or fluid leakage.
Surgical treatment should be halted if the OCT image is poor or disrupted.
During use, the user should not move, shake or bump the delivery system after docking is
completed until patient is disengaged from the system.
2.2.4 Power Failure or Emergency Off
In the event of power failure or initiation of the Emergency Off button, remove the patient
interface tube from the vacuum port to release the eye from suction. Grasp the delivery
system objective and raise it 1 to 2 inches to safely remove the patient from the surgical field.
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The Manual Gantry Lift, located at the base of the gantry, allows the user to lift the unpowered
gantry if additional patient clearance is needed. Alternatively, the patient bed may be lowered
to provide clearance.
2.3 Safety Features
The LenSx Laser complies with all performance standards specified by the Center for Devices
and Radiological Health of the U.S. Food and Drug Administration and international standards
for surgical lasers, and includes the following safety features:
2.3.1 Key Switch
The laser console can be turned ON only with the appropriate master key that controls the
master switch. The key ON switch is located at the bottom center of the front panel of the laser
console. When the master key is turned ON, power is available to the instrument. The master
key cannot be removed when switched to the ON position, and the laser will operate only with
the key in place.
2.3.2 Laser Enabling
When the key switch turns on the system power, a Login window appears. Login prevents
unauthorized use. Following successful login, laser operation is disabled while the
microprocessor checks for basic fault conditions and the system stabilizes. After this period,
the Procedure window will appear on the Display Panel.
2.3.3 Laser Emission Indicator
Laser emission is indicated by a red LASER EMISSION indicator on the Display Panel.
2.3.4 Protective Housing and Safety Interlock
The LenSx Laser has a protective housing that prevents unintentional access to laser radiation.
This housing should be opened only by a qualified LenSx representative.
2.3.5 Labels
Appropriate warning labels are mounted in specified locations on the laser system to indicate
conditions under which the user could be subjected to laser radiation (See Section 10).
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2.3.6 Safety Shutter Monitor
Dual safety shutters, closed unless the system is in the TREATMENT mode, prevent laser
radiation from exiting the instrument. Shutter status is continuously monitored. Should a
malfunction occur (i.e. a safety shutter opens in the absence of a footswitch press) the laser
console is disabled and a messaged is displayed. The LenSx Laser cannot be re‐enabled until
the fault condition has been cleared.
2.3.7 Footswitch Control
The footswitch is housed in an industrial grade enclosure and cannot be activated unless the
LenSx Laser has completed all steps in preparation for laser incision. Position switches in the
housing are arranged such that the footswitch pedal position is redundantly monitored.
2.3.8 Remote Interlock Connector
The system is equipped with an outlet for the interlocking of room doors. A message on the
system display appears when the remote interlock is not connected properly or has been
broken by some action, such as the opening of an operating room door. LenSx representatives
should be contacted for assistance in establishing a remote interlock.
2.3.9 Emergency OFF Switch
The emergency OFF switch is a red button located on the front panel of the console. When
pressed, the emergency off switch shuts off the main system power. This control should be
used only in the event of an emergency.
If the LenSx Laser is shut down (by pressing the Emergency Off button or by a loss of power),
the patient may be removed from under the delivery system by lowering the bed or by
actuating the manual gantry lift located at the base of the delivery system gantry.
To restart the system after the emergency off switch is actuated, twist the red emergency off
button until it disengages; turn the key switch to the OFF position and return it to the ON
position. The system will then reboot normally. Follow the System Startup instruction in
section 4.6.1.
2.3.10
Laser Cooling System
The LenSx Laser uses an internal re‐circulating cooling system whose fluid levels are checked
during preventive maintenance. Coolant levels are automatically monitored by the system and
if a low coolant error occurs, a message is displayed. An authorized LenSx service
representative should be called if a coolant error occurs.
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2.3.11
Manual Gantry Lift
The manual gantry lift allows the user to raise the gantry mechanism up using a manual screw.
The manual lift knob is found at the base of the gantry a few inches above the floor. When the
system is unpowered, the knob is free to turn.
2.3.12
Patient Interface RFID
Each LenSx Laser Patient Interface is instrumented with an RFID tag. The RFID tag authenticates
the Patient Interface for use with the LenSx Laser and prevents reuse or use by unauthorized
patient interfaces.
2.3.13
Console Footbrake
When the laser system is installed, a footbrake at the back of the unit prevents the console
from rolling. The footbrake must be engaged during treatment.
2.4 Device Electrical Classification



Protection against electric shock:
Protection against electric shock Patient Applied Part:
Mode of Operation:
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3 System Description
3.1 Introduction
The LenSx Laser System uses focused femtosecond laser pulses to create incisions and
separates tissue in the lens capsule, crystalline lens and cornea. Individual photodisruption
locations are controlled by repeatedly repositioning the laser focus. The light pulse is focused
into a sufficiently small spot in order to achieve photodisruption of the tissue inside the focus.
A tiny volume of tissue, a few microns in diameter, is photodisrupted at the laser focus. The
surgical effect is produced by scanning thousands of individual pulses per second to produce a
continuous incision or tissue separation. The location of the tissue photodisruption is
controlled by moving the focus of the laser beam to the desired surgical target location. A
computer‐controlled scanning system directs the laser beam throughout a three‐dimensional
pattern to produce an incision. The laser pulses are delivered through a sterile, disposable
applanation lens and suction ring assembly that contacts the cornea and fixes the eye with
respect to the delivery system.
3.2 System Overview
The LenSx Laser is a CDRH CFR 1040 class 3B and a IEC 60825‐1 class 3R laser system for ocular
surgery consisting of the following components:





a laser source to produce femtosecond laser pulses;
an aiming device to localize specific targets in the eye;
an optical delivery system to precisely deliver laser pulses to desired targets in the eye;
computer controllers to perform clinical procedures;
a disposable patient interface optically coupling the eye to the optical delivery system in
order to prevent eye movement.
The LenSx Laser is a stand‐alone unit requiring no external water or gas connections. The
device console houses the laser source, power supplies, control electronics, cooling system,
beam delivery device, optical coherence tomography (OCT) device, video microscope and
computers. The console itself is designed for use in a medical setting meeting US and
international standards (ETL) for electromagnetic emissions for medical devices. The laser
beam and all collateral radiation are completely enclosed inside the console. The Key ON
switch and Emergency Off button are located on the front panel of the console where they are
easily identified and accessed. The LenSx Laser System is shown in Figure 3‐1.
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Figure 3‐1: LenSx Laser System
An all‐solid‐state laser source produces a kHz pulse train of femtosecond pulses. The amplified
pulse train is routed through a beam monitoring assembly comprised of energy monitors, an
energy attenuator and the primary safety shutter. An optical articulated arm directs laser light
to the delivery system where a second shutter controls the beam. Computer controlled
scanning mirrors direct the light through a beam expander and through a focusing objective
onto a spot at pre‐determined depth within the eye. An optical coherence tomography (OCT)
imaging device and a video camera microscope (VM) are used to localize specific targets and to
view the patient’s eye.
The LenSx Laser System uses a sterile disposable patient interface that attaches to the distal
end of the focusing objective. The patient interface is lowered to the eye until it contacts the
eye. Suction then holds the eye in position. Once parameters for the desired procedure are
selected using the software interface, the procedure is initiated by pressing the footswitch.
Although the system computer controls the laser operation during the incision and laser pulse
positioning, the procedure may be stopped at any time by releasing the footswitch.
The following sections briefly describe the major components outlined in Figure 3‐1.
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3.2.1 Femtosecond Laser Engine
Consistent with well‐established femtosecond laser principles, the laser engine uses a
conventional amplified laser design in which pulses with sufficient bandwidth are generated by
an oscillator, amplified to higher energies, and finally compressed in time to femtosecond pulse
duration.
The oscillator produces femtosecond laser pulses of nanojoule energy. These pulses are
temporally expanded by a pulse “stretcher” and are then directed into a diode‐pumped
regenerative amplifier where the pulse energy is increased as the pulse completes a number of
round‐trips within the amplifier cavity. When the pulse energy reaches microjoule energies,
the pulse is switched out of the amplifier cavity. Amplified pulses are routed to a grating
compressor to temporally compress the pulses back to the femtosecond range.
3.2.2 Energy Monitor
The beam of compressed pulses from the laser then enters the energy monitoring assembly. A
computer controlled energy attenuator adjusts the beam energy to programmed levels and
energy monitors verify the beam energy. A primary shutter, that is normally closed when not
energized, controls the release of the beam from the energy monitor. Electronic hardware
closes the shutters in the event that the energy monitors report an unexpected or out‐of‐
tolerance pulse.
3.2.3 Delivery System
The delivery system focuses the beam of laser pulses onto a focus spot at a programmed
location. Upon exiting the energy monitor, the beam enters an articulated arm that terminates
at the delivery system. A second shutter at the delivery system controls the laser beam
through the delivery system. The beam then enters a set of computer controlled scanning
mirrors that scan the beam into a beam‐expanding telescope. Each scanned position of the
beam corresponds to an X, Y location in the focal plane of the focusing objective. The Z position
of the focused laser spot is computer controlled by optical zoom lenses located in the beam
expander. The entire delivery system is mounted on a motorized gantry attached to the system
console to allow the user to position the delivery system.
The alignment of the beam through the delivery system is automatically verified before each
procedure. Users can also request that an alignment check be performed using the Beam
Steering selection in the System Checks menu.
3.2.4 Video Microscope
The delivery system includes a Surgical Display that provides a video microscope view of the
surgical field at all times. Illumination of the field is controlled with an internal electronic
controller and a touch screen interface mounted on the console. The video image provides the
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surgeon with surgical details such as the position of the pupil. The surgeon observes the video
image to adjust and verify the position of the surgical patterns during programming and
performance of the procedure.
3.2.5 Optical Coherence Tomography (OCT) Imaging Device
The Surgical Display also includes an optical coherence tomography (OCT) based imaging device
that assists in localizing specific target locations. The OCT consists of a low power visible
wavelength light source that is scanned throughout the transparent structures of the anterior
chamber of the eye. Light scattered from ocular structures and surfaces within the eye is
analyzed to produce cross sectional images of the eye’s anterior segment. Various sectioned
images may be produced, including a wide field line scan of the anterior chamber, magnified
cross sections of the cornea at the points of planned incisions, and circle and line scans of the
lens and capsule. The surgeon uses these OCT images to adjust and verify the position and
orientation of the selected surgical patterns.
3.2.6 Patient Interface
The LenSx Laser uses a sterile, disposable Patient Interface (Figure 3‐2). The Patient Interface is
comprised of an applanation lens, suction ring and tubing. The suction ring and curved
applanation lens are integrated into a single piece and mounted on the laser delivery system.
The Patient Interface is mounted onto the distal end of the laser focusing objective and serves
as a sterile barrier between the patient and the laser. Tubing is connected to a filter and to a
vacuum port on the laser system. The Patient Interface also contains an integrated passive
RFID identification device. The RFID identifier is sensed by a reader located inside the LenSx
Laser System console. The lens is lowered onto the patient’s eye until the cornea is applanated;
suction is then activated.
Figure 3‐2: LenSx Laser Patient Interface – (1) Interface
Cone and gripper; (2) tubing; (3) filter and RFID; (4)
vacuum port.
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Using the gantry joystick and visualization via the video microscope, the curved applanation
cone (that is attached to the laser delivery system) is lowered to make contact onto the eye.
The applanation force indicator is in the yellow or green zone when adequate applanation force
is achieved, allowing the surgeon to apply suction via touch screen activation of an internal
pump to fixate the eye. Graphical overlay software tools (reference to a live video image of the
eye on the graphical user interface) are used to adjust the centration of the programmed
cutting pattern to the desired position.
When the procedure is completed, suction is released and the focusing objective is lifted,
removing the applanation lens from the surface of the eye. The applanation lens and tubing
are then disposed.
3.2.7 Surgeon Controls
The surgeon controls the LenSx Laser primarily by a console interface comprised of two display
monitors (the Display Panel and Surgical Display), a keyboard, a touch pad and a trackball.
Parameters for photodisruption pattern and system information are entered at the console
interface. The system software allows the surgeon to select pattern parameters and to prepare
the laser for treatment. Directly next to the console interface are the master key switch, which
is used to start the system, and the emergency OFF switch.
Other important surgeon controls include an X, Y, & Z joystick that actuate the motorized
gantry supporting the delivery system. The joystick is used to align the delivery system over the
patient and to make contact with the patient eye. A small touch screen is used to control the
utilities associated with the delivery system, including the illumination controls, docking
controls and video microscope focusing controls.
A footswitch allows the surgeon to start and stop laser treatment. The surgeon initiates laser
treatment by first navigating the software interface until the system is READY and starts the
treatment by pressing the footswitch. The surgeon can interrupt the procedure at any time by
releasing the footswitch. After interruption, the surgeon restarts the procedure by pressing
and holding down the footswitch again. The laser will continue the treatment until the
programmed pattern is complete.
3.2.8 System Electronics
The LenSx Laser console can be configured for 100V, 120V, 220‐240V, 50/60Hz operation. AC to
DC converters supply system electronics, laser diodes and thermoelectric coolers with low
voltage DC current. The maximum power draw is less than 1.2 kW.
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Electronic sensors monitor the position of the patient interface when mounted onto the
delivery system. If the applanation lens is unlocked or out of position, hardware sends an error
to the computer and prevents the procedure from starting. In addition, sensors authenticate
the patient interface via the RFID tag on each patient interface.
A computer monitors and controls the beam energy, repetition rate, safety shutters,
footswitch, laser diagnostics, the position of the scanners and the position of the scanning
objective lens. Hardware monitors the functioning of the computer and computer software. If
an unsafe condition occurs, the safety shutters are immediately closed and the surgeon alerted.
In addition, the surgeon monitors the procedure through the video microscope and can halt the
procedure at any time by releasing the footswitch.
3.2.9 Console Chassis
The entire laser console is enclosed by a metal skin. These coverings cannot be removed
without special tools. The laser radiation is not accessible outside the console chassis until the
treatment beam exits the system at the patient interface. The console is designed for use in a
surgical setting, it is easy to clean, and meets US and international standards for
electromagnetic emissions from medical devices. The patient applied part is classified as
floating “BF” device and is electrically isolated from the system electronics and mains input.
3.3 Procedure Overview
The LenSx Laser is indicated for use in patients undergoing cataract surgery for removal of the
crystalline lens. Intended uses in cataract surgery include anterior capsulotomy,
phacofragmentation, and the creation of single plane and multi‐plane arc cuts/incisions in the
cornea, each of which may be performed either individually or consecutively during the same
procedure.
The LenSx Laser focuses a beam of low energy pulses of infrared light into the eye. Each pulse
of energy creates photodisruption of a micro‐volume of tissue at the focus of the beam. When
scanned, the beam places individual photodisruption sites in a contiguous pattern to form
continuous incisions. The spacing between photodisruption sites is programmed by the user. A
typical incision consists of several tens of thousands micro‐disruptions. By programming the
size, shape and location of the scanning pattern, incisions are created.
An anterior capsulotomy incision consists of a cylindrical cut starting from below the surface of
the anterior capsule and continuing through the capsule a few microns into the anterior
chamber.
A lens phacofragmentation incision consists of two or more vertically oriented elliptical‐ shaped
planes that intersect at the center of the lens. The maximum cutting depth should be at least
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500 m above the posterior capsule. The cuts proceed from the deepest point and move
anteriorly, ending below the anterior capsule.
A partial thickness or full thickness cut for cataract surgery consists of an arc cut starting from
the desired corneal thickness and continuing anteriorly towards the corneal epithelium. These
cuts can consist of 1, 2 or 3 planes.
3.3.1 Pre‐Operative Steps
The LenSx Laser uses a proprietary sterile disposable Patient Interface. The Patient Interface is
comprised of an integrated applanation lens, suction ring, and tubing that connects to the
suction port of the LenSx system. The patient interface is mounted onto the distal end of the
system focusing objective and serves as a sterile barrier between the patient and the laser.
Sensors in the LenSx console authenticate the patient interface. The surgeon uses the X, Y and
Z joystick control to contact the operative eye. Following applanation, mild suction is applied
via the tubing in order to stabilize the eye. Refer to the Instruction for Use supplied with the
LenSx Laser Patient Interface for preparation and application instructions for the Patient
Interface.
The surgeon observes applanation of the cornea using the video microscope, and then applies
suction when the cornea is properly applanated.
The Surgical Display presents a live video microscope image of the surgical field. Graphics laid
over the image are used to program the lateral position of the incision. When the lateral
position is acceptable, OCT images appear on the right side of Surgical Display. The surgeon
identifies the depth, position of the lens and corneal surfaces using the OCT images. Graphical
tools allow the surgeon to program the incision depths on the OCT images.
Anterior capsulotomy patterns are programmed to cut from at least 100 microns below to 100
microns above the anterior capsule. Lens phacofragmentation patterns are programmed to cut
from at least 500 microns above the posterior capsule to at least 500 microns below the
anterior capsule. Partial and full thickness corneal incisions are programmed as a percentage of
corneal thickness at the position the cut is being made. When programming is complete, the
system performs internal checks and notifies the surgeon when the system is ready to fire.
3.3.2 Anterior Capsulotomy
When the surgeon presses the footswitch, the main shutter is opened and the treatment
begins. The treatment pattern begins as a scanned circle located below the depth of the
anterior capsule. Once a scanned circle is completed, a new circle is scanned a few microns
above the first circle. As each circle is completed, a cylindrical incision is created. The pattern
is automatically completed when the anterior extent of the incision is reached. When the
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pattern is completed, the system automatically closes the main shutter and notifies the
surgeon.
3.3.3 Phacofragmentation
When the surgeon presses the footswitch, the main shutter is opened and the treatment
begins. The treatment pattern begins at the programmed posterior depth as an initial x‐shaped
scan is complete, followed by successive x‐shaped scans created a few microns apart. As each
scan is completed, the lateral extent of the scans is adjusted to fill‐in the elliptically shaped
volume. The result is two or more vertically oriented, elliptically shaped planes that intersect at
the lens center. The pattern is automatically completed when the programmed anterior depth
is reached. When the pattern is completed, the system automatically closes the main shutter
and notifies the surgeon.
3.3.4 Combined Treatments
Treatment patterns may be combined by selecting appropriate combinations of individual
patterns. Not all combinations are allowed. The system software enables allowable
combinations as the pattern selections are made. When the surgeon presses the footswitch,
the main shutter is opened and the first treatment begins. After the first pattern is completed,
the next pattern begins automatically. When the pattern is completed, the system
automatically closes the main shutter and notifies the surgeon.
3.3.5 Post‐Operative Steps
Following completion of the laser procedure, the suction to the Patient Interface is
automatically released. The surgeon then uses the gantry joystick to lift the delivery system
from the patient’s eye. The Patient Interface is disposed of as medical waste.
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4 Controls, Indicators and Displays
4.1 Display Panel & Keyboard
Computer control and software interface functions are performed using the touchpad and
keyboard in conjunction with the display monitors. These are mounted on the console to the
left of the delivery system. The entire station may be swiveled on its mounting post to optimize
viewing and control access. Software functions may be selected by moving a display cursor
with the touchpad and clicking the left button. Selecting a software function causes either a
control function or a menu to appear. Alphanumeric data may be entered using the keyboard.
4.2 Surgical Display
The Surgical Display is mounted over the delivery system. It displays the video microscope and
OCT images as well as the graphical overlays for pattern positioning. A trackball is used to
control the input to the Surgical Display.
4.2.1 Video Microscope
The video microscope image is shown on the Surgical Display. Overlay graphics of the surgical
patterns and centration marks indicate the programmed position of the treatment. The
position and size of graphical marks can be adjusted using the Surgical Display touchpad. The
laser procedure is monitored live using the video microscope view.
4.2.2 Optical Coherence Tomography (OCT) Device
The OCT images are shown on the Surgical Display. Graphics laid over the OCT image indicate
the depths of incisions. The graphics can be vertically (axially) adjusted for position and depth
using the Surgical Display touchpad. Although OCT images are not updated in real time, OCT
images may be taken after the lens phacofragmentation to re‐adjust capsulotomy or corneal
incisions.
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4.3 Delivery System Panel
The delivery system panel is located on the front of the delivery system, just below the video
microscope. This panel contains the following controls:
4.3.1 Joystick
The delivery system is mounted on a motorized gantry that positions the delivery system. The
joystick controls the gantry x‐y‐z positioning: twisting the stick varies the height while deflecting
it controls the lateral positioning. The degree of twist or deflection controls the speed of the
translations. The direction of lateral motion corresponds to the deflection direction. During a
procedure, the joystick controls are disabled.
4.3.2 Delivery System Touch Screen
A small touch screen panel mounted directly on the delivery system is used to monitor and
control some functions of the delivery system. The controls and indicators available on the
touch screen include illumination levels, applanation force indicator, video microscope zoom
and focus controls, and the fixation light on/off switch. Touching the screen allows the user to
adjust or select the controls.
4.3.3 Applanation Indicator
The objective lens of the delivery system is spring‐loaded to control the applanation force
exerted by the objective. The delivery system is lowered until the Patient Interface makes
contact with the patient’s eye. When initial contact is made, the objective lens moves upward.
Sensors in the delivery system detect the objective’s position and applanation force. The
applanation force is indicated on the Delivery System touch screen. As the objective is lowered,
the indicated applanation force increases until, at a preset position, the maximum applanation
force is achieved and further downward motion ceases. Only motion in the upward direction is
enabled.
4.3.4 Illumination and Microscope Focus
Two illumination sources are available on the LenSx system: internal to the patient interface
and external from the objective. External field and internal field Illumination levels are
continuously varied using the delivery system touch screen. The camera focus for the video
microscope can be changed using the Focus controls. Focusing of the microscope view is useful
for visualization of the subject eye during Docking, Pattern Positioning and Laser treatment.
The Zoom and Illumination controls are located on the Delivery System touch screen. Section 6
– Procedure Guide describes the use of these controls.
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4.3.5 Fixation Light
A fixation light is available to help a patient orient the eye during the Docking procedure. The
switch for the fixation light is a button on the Delivery System touch screen.
4.4 System Power
4.4.1 Main Input Switch
After the LenSx System is connected to line power, electrical service to the console is switched
on with the rocker switch located on the back panel of the console. When switched ON, power
is switched to the transformers and to the laser chiller. The laser engine and computer systems
are not turned ON.
4.4.2 Key Switch
Located on the front console panel, the key switch has two positions: “O” and “I”. Rotating the
key from O to I turns on the main power to the system computers and initiates laser warm up
and self‐checking routines. Normal shutdown of the system power is accomplished by rotating
the key on switch from I to O.
4.4.3 Emergency off switch
Located on the console front panel, the emergency off switch is an easily accessible, large red
button. When pressed, the system power is immediately cut off. Use of the emergency off
switch should be limited to emergencies and not for normal shut down of the system.
4.5 Footswitch
When the system is ready to commence a treatment, the surgeon starts the treatment by
pressing the footswitch. The footswitch is actuated by placing a foot inside the housing and
pressing the hinged, spring‐loaded pedal until it contacts the bottom of the footswitch. The
footswitch must be connected to the console while the system is switched ON.
4.6 Software Controls
4.6.1 System Startup
When power to the LenSx Laser is switched on, the user encounters the system access Login.
Following successful user login, a warm‐up and self‐check phase is initiated. Status of the
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system during the warm up and self‐test phase is indicated on the screen. At the conclusion of
the warm up phase, the system is ready for use.
4.6.2 Procedure Programming Window
Following successful login, system warm up and self‐ test, the Procedure window will be
displayed. See Section 6 – Procedure Guide for programming instructions.
4.6.3 System Checks
All non‐procedure system functions are accessed using the System Checks button. Selecting
this button brings up a menu, including:

The Energy Calibration option will cause the LenSx Laser to initiate a procedure that will
verify the system’s energy calibration.

Selecting Beam Steering will cause the LenSx Laser to initiate a routine that checks and
adjusts, if necessary, the alignment of the laser beam into the Beam Delivery System.
4.6.4 User Registration
User Registration allows for adding or removing users.
4.6.5 Shutdown
The system is shutdown by turning the key switch to the “O” position.
4.6.6 About
The About button produces a window displaying contact information, the system serial number
and current software version number.
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4.7 Accessories & Detachable Parts
The following accessories and detachable parts are used with the LenSx Lasers:
ACCESSORY / PART
LOCATION
INSPECTION / REPLACEMENT SCHEDULE
Footswitch
Rear Panel
Inspected at installation
Fuse:
3AG, Fast Acting, 250V,
15A (x2)
Rear Panel
Inspected at installation / replaced as
needed
LenSx Patient Interface
Attaches to deliver
system
Single use, disposable device. Dispose
as medical waste.
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5 System Requirements
5.1 Electrical
The LenSx Laser is configurable for 100V/12A, 120V/10A, 220‐240V/7A, 50/60Hz. The
maximum power draw is less than or equal to 1.2 kW. The line voltage should be tested upon
installation to ensure proper operation and should not vary by more than +/‐10% from nominal.
The line and Neutral voltage is fused protected at the rear panel: 3AG, Fast Acting, 250V, 15A.
5.2 Environmental
Ambient temperature in the room containing the LenSx Laser should remain between 18°C and
24°C (65°F and 75°F). The ideal climate should be between 30% and 40% humidity.
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6 Procedure Guide
The LenSx Laser System allows the surgeon to program phacofragmentation, anterior
capsulotomy, partial thickness and full thickness corneal incisions for cataract surgery,
individually or combined in a single treatment session. The purpose of this section is to provide
step‐by‐step instructions in the use of the LenSx Laser to program and execute a treatment
session.
The LenSx Laser System allows the surgeon to tailor specific treatment patterns for each
patient. After programming a treatment pattern and docking the system, the surgeon may
adjust the treatment pattern position using information provided by the video microscope and
OCT images. After confirming the treatment, the surgeon initiates and monitors the laser
treatment.
6.1 Preparation and Treatment Planning
Prior to the actual treatment, the LenSx Laser System is turned on and used to specify and plan
the surgical procedure using the system software and graphical user interface.
6.2 Start Up & Procedure Selection
Rotate the key on switch from the “O” position to the "I" position.
The LenSx Laser System software will be initiated and the Display Panel will display graphical
user interface (GUI) information. User inputs to the GUI are made with the touchpad and
keyboard peripheral devices. The first screen displayed is the Login screen (Figure 6‐1). Select
the “doctor” option, enter a valid password.
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Figure 6‐1: Log‐in screen for the LenSx Laser System
In this first screen, options for saving or printing treatment parameters may also be selected.
Saving or printing parameters may be useful as the initial choice of parameters can change
during the pattern positioning steps taken after docking and under visualization with the video
microscope and OCT imaging devices.
After system warm up and self‐checks have been completed, the Biometrics window will
appear on the Display Panel (Figure 6‐2). A status indicator located on the right side of the
biometrics window displays relevant system status.
Figure 6‐2: Patient biometric data screen
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Within the Biometrics screen, patient biometric data collected during pre‐surgical visits may be
entered. Biometric data includes the lens thickness, and central corneal thickness. Other
patient data includes patient and physician identification information.
The biometrics data may be used to define the positioning and orientation of the patterns if
some or all of the OCT image guides are not used. For example, some lenses may have high‐
grade cataracts or opacities that prevent visualization of the posterior capsule. In the event of
poor visualization of the posterior capsule, biometric data from A‐scan ultrasound may be used
to define the extent of the Lens pattern for phacofragmentation.
Once the biometric data has been entered and verified, press “Accept Pre‐Op Data” to continue
with treatment planning.
The Biometrics screen is now replaced with the Pattern Selection window shown in Figure 6‐3.
The Pattern Selection window displays the patient ID, controls for selecting and initiating
programming of procedure types, an abbreviated view of the selected parameters for the
various corneal incisions, the system status indicator box, and the Dock button.
Figure 6‐3: Pattern Selection screen.
From the white pull‐down menu, select a default or previously saved pattern.
Using the Select bar, the user may select a cutting pattern from the row of blue buttons. These
selections determine the combination programmed treatments for a single session. When
selected, the button is highlighted to indicate that selection.
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Alternatively, previously saved patterns may be recalled using the Saved Pattern pull down
menu located between the patient ID information and the Select bar.
Pressing the arrow button located at the lower right corner of the screen returns the display to
the Biometrics screen.
Figure 6‐4: Pattern Selection screen appearance after a saved
pattern file has been recalled. The cornea incisions loaded from
the saved file are displayed in abbreviated form in the Quick
View box at the top right side of the screen.
After selecting a saved pattern, or selecting appropriate pattern elements from the Select bar,
parameters may be specified for each pattern segment. Located directly below the Select bar is
the Program bar. Each Program bar button corresponds to a Pattern button from the Select bar
above. Selecting one of the Program bar buttons opens the parameter window for the
corresponding pattern element. Note that selecting parameters from inside a particular
Program bar selection window will not cause the Pattern to be enabled until the corresponding
Select bar button has been pressed.
After a Pattern has been loaded or selected, the Cornea Incisions – Quick View field is
populated with parameters for the various corneal incisions selected (upper right section of
Figure 6‐4).
Each Pattern has a number of parameters associated with the particular type of cut and tissue.
For each Pattern selected, the parameters must be specified or verified prior to initiating the
laser surgical procedure. In the following sections, the process of specifying or programming
appropriate Patterns is outlined.
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6.2.1 Programming the Lens Pattern
The Lens Pattern is used to perform phacofragmentation of the crystalline lens. Lens Patterns
may be specified as either Chop or Cylinder patterns. The Chop Pattern is a series of vertical
planes arranged radially in the lens, resembling the spokes of a wheel centered on the lens.
The Cylinder Pattern a series of vertically oriented concentric cylinders centered on the lens.
When the Lens button has been pressed under the Program bar, the Lens Pattern parameter
screen is displayed (Figure 6‐5). User‐settable parameters are displayed, with the present value
for each parameter shown. Use the individual parameter buttons to increment or decrement
each value. On the right side of the screen, columns of parameters may be specified for either
the Chop or Cylinder patterns.
Figure 6‐5: Lens Pattern parameter screen
Selectable parameters may be geometric or laser scanning parameters. Geometric parameters
include the anterior capsule depth, the posterior capsule depth, and the lens diameter. Laser
scanning parameters for the Lens screen include the separation of consecutive laser shots (spot
separation) and the laser pulse energy. The parameters displayed depend on the particular
pattern selected.
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For the Lens Pattern only, OCT images of the post‐laser treatment lens may be saved in order to
evaluate the effect of the Lens Pattern on the positioning of subsequent patterns on the
capsule and corneal patterns. If the Post‐Lens OCT image is selected, the laser procedure will
halt and provide an opportunity for the user to re‐position the subsequent patterns before
completing the procedure.
Select appropriate parameters. Press the Accept and Save buttons at the bottom of the Lens
Pattern parameters. A dialog window for entering a file name to be saved is displayed.
Previously saved parameters files may also be recalled and loaded by selecting the Param Files
button. The system software returns the display to the Pattern Selection screen.
6.2.2 Programming the Capsulotomy Pattern
The Capsule Pattern is used to perform an anterior capsulotomy of the crystalline lens. The
anterior capsulotomy is created by scanning a cylindrical shell extending from a position in the
lens volume through the capsule and into the anterior chamber. The cylindrical scan pattern
penetrates the capsule in a complete circular shape.
The Capsule Pattern parameter screen is used to select treatment parameters. These include
the capsulotomy diameter, the estimated capsule posterior depth, the estimated capsule
anterior depth, the capsule delta up distance, and the capsule delta down distance. As in the
Lens Pattern, laser energy, spot and line separation distances may be specified.
The surgeon can elect to perform the capsulotomy cut either before or after the Lens Pattern is
executed by selecting the Capsulotomy First button. The Capsule Pattern scan can also be
selected to begin either at the posterior (bottom) or anterior (top) end of the scan pattern by
toggling the Scan Start parameter.
After the information has been entered correctly, press the Accept and Save buttons displayed
at the bottom of the Capsule Incision parameter screen. The system returns to the Select
Patterns screen.
6.2.3 Programming the Primary Incision Pattern
The Primary Incision Pattern is used to create corneal incisions for penetrating keratoplasty or
for cataract surgery.
The geometry of the Primary Incision Pattern is constructed from one, two or three angled
planes arranged along a defined arc at the corneal periphery. The planes are connected to
create a single opening. The Primary Incision Pattern may represent a completely penetrating
cut or a partial thickness cut. Partial thickness cuts can be created and later opened manually
by the surgeon.
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Primary Incision Patterns begin at the programmed maximum posterior depth and progress
anteriorly until the programmed anterior depth is reached. Depths are expressed as a
percentage of the corneal thickness. Corneal thickness can be defined pre‐operatively or by
using the OCT image. (Figure 6‐6)
Figure 6‐6: Primary Incision Pattern parameter screen
The Primary Incision Pattern parameter screen allows the user to specify pattern geometry and
laser scanning parameters. The basic shape is an arc cut at the periphery of the cornea. Users
can select one, two or three plane incisions. The depth of each plane is set with the % Poster
Depth parameter. The Side Cut Angle is angle that the plane makes with the corneal anterior
surface. The planes may be overlapped to ensure complete cuts using the Ant Overlap
parameter.
After the information has been entered correctly, press the Accept and Save buttons displayed
at the bottom of the Primary Incision Pattern parameter screen. The system returns to the
Select Procedures screen.
6.2.4 Programming the Secondary Incision Pattern
The Secondary Incision Pattern is used to create a corneal incision and is similar to the Primary
Incision Pattern. Secondary Incision Patterns may be used to aid cataract surgery.
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The Secondary Incision Pattern a single angled plane located along an arc on the corneal
periphery. The pattern is defined by the distance of the arc from the limbus, the radius of
curvature of the arc, and the angular location of the arc. The Side Cut Angle defines the angle
that the planar cut makes with respect to the cornea surface. The Secondary Incision Pattern is
specified as a penetrating or a partial thickness keratoplasty cut by selecting the appropriate
value for the % Posterior Depth parameter. The amount of overcut above the corneal anterior
surface can be specified with the Anterior Overlap parameter.
After all parameters have been entered, press the Accept and Save buttons displayed at the
bottom of the screen. The system returns to the Select Procedures screen.
6.2.5 Programming the Arcuate Incision Patterns
Arcuate corneal cuts can be made using the Arcuate Incision Pattern. Arcuate Incision Pattern
cuts are made in the corneal periphery, and are arc‐shaped partial thickness cuts. Arcuate
Incision Pattern cuts start at a user‐programmed posterior depth and progress in the anterior
direction. The pattern depth chosen using the % Posterior Depth button and is expressed as a
percentage of corneal thickness. Choosing the Diameter parameter determines the circle
diameter wherein the arc cuts lie. Either one or two arcs may be selected using the Two
Arcs/One Arc button near the bottom of the screen (see Figure 6‐7). The depth of the arc cuts
is specified with the % Posterior Depth parameter.
The Before Cornea Incisions button can be used to determine whether the pattern is executed
before or after other corneal incision patterns.
After all parameters have been entered, press the Accept and Save buttons displayed at the
bottom of the screen. The system returns to the Select Procedures screen.
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Figure 6‐7: Primary Incision Pattern parameter screen
6.2.6 Combining Patterns
Patterns may be combined in various ways to achieve a desired surgical procedure. Select
appropriate pattern buttons in the Pattern Selection screen allows the surgeon to create the
desired pattern combinations. However, not every combination of patterns is allowable. To
view the allowed combinations in any pattern screen, select the Select Cuts button. A table of
combinations is shown in a window (Figure 6‐8 below). This window also shows the currently
selected combination of patterns.
During laser treatment, the patterns will be executed in a sequence that generally proceeds
from the most posterior cuts to the most anterior cuts. In some cases, the order of cuts may be
specified within the pattern parameter screen.
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Figure 6‐8: Allowed pattern combinations.
6.2.7 Completing Pattern Selection
Once all the pattern selection and parameter programming has been completed, press the Save
button located in the Corneal Incisions – Quick View box at the top of the Pattern Selection
screen. To proceed to Docking, press the Dock button located at the far right side of the Select
bar choices. The Treat screen will be then be displayed (Figure 6‐9 below)
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Figure 6‐9: Display Panel showing the Treat screen immediately
after pressing the Dock button in the Pattern Select screen. The
Treat screen indicates the system status in the box at the upper
right and is used to initiate suction.
6.3 Preparing the Patient Interface
When all pattern selections and parameter choices are complete, the system is ready to dock
with the patient. After Docking has been successfully completed, the planned treatment
patterns are oriented and adjusted with respect to the targeted ocular tissues in the Pattern
Positioning process (Section 6.5)
The LenSx Laser System uses a proprietary disposable Patient Interface (PI). The sterile PI is
comprised of an applanation lens, suction ring, and tubing (see Figure 3‐2).
Open the packaging and place the PI onto a sterile field. Inspect the components of the PI for
damage or disconnection. Grasp the contact lens mount of the PI. Place the contact lens
mount on the delivery system laser aperture; twist the contact lens mount until it locks into
place. Grasp the vacuum tube and insert it onto the vacuum port on the LenSx Laser System.
The PI also contains an integrated passive RFID identification device. The RFID identifier is
sensed by a reader located inside the LenSx Laser System console. The Treat screen status
indicator PI is displayed when the PI has been properly installed and the RFID transponder
detects a valid identification code on the PI.
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Once the PI has been properly installed on the LenSx Laser System, the patient should be
prepared for Docking.
6.4 Docking
Place the patient in a supine position under the delivery system and Patient Interface. Apply a
topical antiseptic to the eye prior to Docking.
Use the joystick to control the gantry and roughly align the Patient Interface to the eye.
While the patient’s eye is located at distances greater than 1 centimeter from the PI, use the
Zoom button on the Delivery System Touch screen to adjust the video microscope
magnification.
Touch the external illumination bar on the Delivery System Touch screen to set the desired
level of Illumination. Touch the fixation light button to switch on the patient fixation light.
Instruct the patient to maintain fixation on the light during the Docking process.
Use the joystick to center and lower the gantry until the Patient Interface contacts the eye. The
Delivery System Touch screen monitors the applanation force continuously. The Treat screen
will show the CONTACT status indicator when the force sensor integrated in the delivery
system detects an initial applanation force. Graphical indicators show both the desired range
of force and the measured force (see Figure 6‐10 below). Use the joystick to adjust the
applanation force to the desired range.
Switch off the microscope Zoom. The Surgical Display now shows only the internal view of the
eye. Touch the internal illumination bar to set the desired level of illumination.
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Figure 6‐10: Left image shows the main Delivery System touch screen display. Set
illumination levels by touching the wide vertical bars. Right image is displayed after selecting
Video. Adjusting the camera focus zoom allows good visualization before the PI contacts the
cornea. P1‐P4 are focal position pre‐sets. The applanation force indicator is on the right side
of every screen. The applanation force is correct when the white ellipse is in the green range.
Figure 6‐11: Surgical Display during Docking. The dashed lines represent centration guides
and are used to position the delivery system and PI with respect to the patient eye.
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Use the Surgical Display to verify that the PI is nominally centered on the cornea, slowly
adjusting the joystick as necessary to center the PI on the cornea. Once the PI has been
properly centered, press the PI SUCTION control button located at the lower left corner of the
Treat screen. A low vacuum level applied to the PI gently fixates the eye to the contact lens.
The joystick control is now inactive and the gantry cannot be moved until the suction is
released. The Surgical Display screen then changes to show a live video image of the
applanated eye and an indication that the OCT has been activated. The LenSx Laser System is
now ready for positioning of the selected patterns.
6.5 Pattern Positioning
6.5.1 Overview
Once the delivery device and Patient Interface has been docked onto the patient’s eye, the
selected and programmed patterns may be re‐positioned.
The Video Microscope and OCT are used to guide the positioning steps. The Surgical Display
overlays the selected patterns onto the video microscope and the OCT images. The overlay
patterns are shown as the outlines and centers of the patterns, along with graphical tools for
manipulating and positioning the patterns.
The LenSx Laser System software assists the user in the positioning process. At each step, the
user’s next action is highlighted and appropriate buttons and views are enabled. Adjustments
made by the operator with the aid of video microscope and OCT image guides are used to
update the pattern positioning information stored by the LenSx Laser System.
The general order of pattern positioning and centration adjustments is as follows:









Docking/PI Suction
Limbus centration
Primary and secondary incision pattern alignment
Lens centration
Capsulotomy and lens diameter adjustment
Arcuate incision angle and diameter adjustment
Capsule depth and cutting range adjustments
Capsule/lens positioning alignment
Cornea thickness measurements (primary, secondary and arcuate incisions)
Some pattern positioning steps may be omitted, depending on the patterns selected. The
progression of pattern positioning steps is shown by changes in the status indicators located at
the bottom of the Surgical Display. Highlighted action buttons indicate the required next steps
for the user.
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At any point in the pattern positioning process, selecting the action button with an arrow allows
the user to return to the previous step or to exit the pattern positioning process.
6.5.2 Video Microscope, OCT Image Guides and Pattern Graphics
During pattern positioning, the Surgical Display shows a live video image of the eye on the top
left side and OCT images on the top and bottom right side. On the bottom of the display, the
status indicator and action buttons are displayed.
Graphical overlays on the Surgical Display and OCT images indicate the planned incision
patterns and their relationship to the ocular tissues. Solid lines in the graphical overlays
represent the outer boundaries of the patterns. Dashed lines represent centration or positional
information relative to the video microscope and OCT images.
Control points are small solid circles that represent user‐adjustable parameters. Point the
cursor and click on a control point to make it active. Active control points can be moved by
dragging the cursor to the desired location. A second click on the control point deactivates the
control point. Active control points are a different color than inactive control points. Only one
control point is active at any time.
6.5.3 Limbus Centration
After PI Suction has been initiated, limbus centration lines are overlaid on the Surgical Display.
No OCT scans are used in this positioning step.
The limbus centration control points in the video microscope display are active. Place the
cursor on the control point. Click and drag the control point to center the limbus centration
lines on the limbus. Click again on the control point when centration is complete. The control
point indicator changes appearance to indicate completion of this step. See Figure 6‐12.
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Figure 6‐12. Limbus centration. Red arrow points to control
point (blue dot) used to position the guides (white dashed lines)
on the limbus. In this example, the Primary (heavy yellow),
Secondary (orange), Arcuate (white), Capsule (pink) and Lens
(light yellow) patterns have been selected.
6.5.4 Primary and Secondary Incision Alignment
If Primary or Secondary Incision Patterns are selected, the next step in pattern positioning is the
radial location of these patterns. The pattern locations are displayed on the video microscope
image on the Surgical Display. No OCT scans are used in this positioning step. A control point
for the Primary Incision Pattern is active. Move the control point by clicking and dragging. The
Secondary Incision Pattern is similarly positioned after the Primary Incision Pattern control
point is deactivated with a second mouse click.
After completing the Primary and Secondary Incision Pattern positioning, an action button
(either Scan or Limbus Centration) will cause the LenSx Laser System to verify that the adjusted
pattern positions are consistent with other patterns and parameters. If the verification step
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results in an error, a dialog box will alert the user to correct the pattern positioning before
allowing the next step.
Figure 6‐13: Primary Incision Pattern positioning. Red arrow points
to control point (blue dot) used to move the Primary Incision
Pattern (heavy yellow shape at right) along the radial direction.
Secondary Incision Pattern positioning proceeds in the same manner
after the control point for the Primary Incision Pattern has been
deactivated with a second click.
6.5.5 Lens Alignment
If lens or capsule patterns are selected, the Lens Centration action button will appear. If lens or
capsule patterns are not selected, the lens alignment step will not be performed. Press the
Lens Centration action button. Several control points may appear on the Video Microscope
image, depending on the combination of patterns. No OCT scans are used in this positioning
step.
The control points to be adjusted may include the Lens Pattern center, the Capsule Pattern
diameter, the Lens Pattern diameter, and the Arcuate Incision Pattern diameter. Select and
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activate each control point in turn, and adjust the Len center and pattern diameters as
appropriate. Users should verify that the Lens Pattern diameter falls within the 8mm diameter
lens alignment dashed circle.
If necessary, the Arcuate Incision Pattern may be rotated in either direction up to a maximum
of 20 degrees from the originally programmed value. Hold down the clockwise (CW) or
counterclockwise (CCW) button to attain the desired rotation angle.
Figure 6‐14: Control points displayed in the Lens Pattern positioning
step. Not all adjustments may be shown depending on the patterns
selected. Arrow 1 = Lens Pattern centration, Arrow 2 = Capsule Pattern
diameter, Arrow 3 = Lens Pattern diameter, Arrow 4 = Arcuate Incision
Pattern diameter. When all positions have been adjusted, the Lens
status bar changes indicating completion of this step.
6.5.6 Capsule Depth Adjustment
After completing the Lens positioning steps, the next positioning adjustments are the ranges for
capsule incisions (if Capsule Pattern has been selected). A circle scan OCT image of the lens and
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capsule is displayed the top right area of the Surgical Display. The circle scan is performed
along the Capsule Pattern diameter as defined on the video microscope image of the eye.
Figure6‐15: Rough adjustment of the Capsule pattern range.
Control points can be moved up or down. The solid line represent
previously programmed values for the Delta Up and Delta Down
Two horizontal dashed lines are overlaid on the OCT image. Control points for the depth range
adjustment and two other solid lines without control points are shown. The numeric values of
the previously programmed up delta/down delta values are displayed.
The Anterior Depth control point can be moved vertically for depth. It can also be moved
horizontally to indicate the angular position of the high point of the capsule. This Anterior
Depth control point has short dashed line to indicate the ability to move it horizontally.
Move the Anterior Depth control point to the minimum depth of the capsule. Move the
Posterior Depth control points to the maximum depth of the capsule. The solid Delta Up/Delta
Down lines will move with the dashed horizontal lines associated with each control point. The
Delta Up and Delta Down values themselves do not change. The positions of the maximum and
minimum capsule positions determine the axis of tilt of the lens.
Press Zoom In when done. An enlarged image is shown and the control points allow for finer
adjustment of the capsule depth range.
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Figure 6‐16: Fine adjustment of the Capsule pattern range. The
Anterior Depth and Posterior Depth control points are properly
positioned. Pressing Accept stores the adjustments and enables
the next Capsule range adjustment step.
When the Capsule range adjustments are complete, press the Accept button. The LenSx Laser
System software checks that the adjustments are valid for the patterns selected. If the
adjustments check is successful, the video microscope image shows a dashed line indicating the
tilt axis of the lens.
The Capsule Range status indicator changes to indicate completion, and the next pattern
positioning step is enabled.
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Figure 6‐17: Completion of Capsule Range adjustments. The phase
angle associated with the capsule tilt is indicated by the dashed line
(red arrow).
6.5.7 Lens Depth Adjustment
The Capsule position adjustment allows the user to adjust the position of the Lens patterns to
match the surfaces and volume of the lens.
The adjustments are made for the depths corresponding to the posterior and anterior limits of
the capsule and lens location. A line scan OCT image along the tilt angle previously defined is
displayed with control points for the Anterior Capsule Depth, the Posterior Capsule Depth, and
the maximum allowable depth. The control points can only be adjusted vertically.
If the Capsule pattern is enabled but the Lens Pattern is not, no control points will be available.
For this combination of pattern selections, the Capsule positioning step is only used for
displaying stored results.
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The initial values for the control point depths correspond to pre‐programmed values and values
stored from previous pattern positioning steps.
Figure 6‐18: Adjustments for the Capsule Position step. Anterior
Capsule depth and Posterior Capsule depth control points are
adjusted vertically. The maximum allowable depth is represented
by a fixed dashed line (Max Depth). The OCT line scan is
superimposed with the diameters of the Capsule Pattern (pink) and
the volume outline of the Lens Pattern (yellow lines and curves).
Two solid (purple) vertical line segments are displayed representing the Capsulotomy Pattern.
The capsulotomy diameter range is represented by the separation of the lines and the Capsule
depth range is represented by the position and vertical height of the lines.
The Lens treatment volume is represented by an upper arc, a lower arc, and two vertical lines
(all in yellow). The distance between the left and right vertical lines represents Lens diameter
value stored in the Limbus Centration positioning step. The upper arc matches the Anterior
Lens Curvature and the lower arc corresponds to Posterior Lens Curvature. Both curvature
values are default values or user‐supplied values taken from the Lens parameters screen. The
difference between the Anterior Capsule Depth and the top of the upper arc is equal to the
Lens Anterior Offset from the Lens parameters screen. The depth difference between the
Posterior Capsule Depth and the bottom of the lower arc is equal to the Lens Posterior Offset
from the Lens parameters screen.
Adjust the Anterior Capsule Depth control point to a position inside the anterior capsule apex.
The Anterior Capsule Depth numeric value and the Lens Pattern treatment volume are updated
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as the control point is changed.
Adjust the Posterior Capsule Depth to a position inside the posterior capsule apex. The
Posterior Capsule Depth numeric value and the Lens Pattern treatment volume are updated as
the control point is changed.
When the Capsule Position adjustments are complete, press the Accept button. The LenSx
Laser System software checks that the adjustments are valid for the patterns selected. If the
adjustments check is successful, the display shows the Video Microscope image. The Capsule
Position status indicator changes appearance to indicate completion.
If corneal incision patterns have been selected, the final pattern positioning step of Corneal
Thickness is enabled. If not, press the Accept All button to proceed with treatment.
6.5.8 Corneal Primary and Secondary Incisions Thickness Adjustment
If corneal incisions are selected, the last step in pattern positioning is adjusting the corneal
thickness and corneal incision geometry parameters.
The Primary Incision Pattern geometry and the corneal thickness are adjusted first. Press the
Scan button at the bottom of the Surgical Display to proceed. An OCT image of the corneal
region of the Primary Incision Pattern is displayed. The OCT image appears at the bottom right
corner of the Surgical Display.
An X‐Z cross‐section of the Primary Incision Pattern is depicted. This representation of the
incision is referred to as the Tunnel. The Tunnel may be composed of 1, 2 or 3 separate line
segments representing the planes specified in the Primary Incision Pattern parameter
programming step.
Three control points that adjust the Epithelial, Endothelial and Tunnel End are also displayed.
The Epithelial and Endothelial control points are used to set the positions of the anterior and
posterior cornea. The Tunnel End control point is used to position the end of the tunnel.
The Epithelial control point can only be moved along the vertically dashed line. The Endothelial
control point can be moved perpendicularly to the cornea along the normal dashed line. The
Tunnel control point may be moved freely in the horizontal and vertical directions. Moving any
of the three control points causes the graphical feature representing the Primary Incision
Pattern to move as well.
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Figure 6‐19: Completed adjustment of Primary Incision Pattern tunnel
parameters. Pressing the Caps Position button allows the user to switch
between Capsule Position adjustments and Corneal Thickness
adjustments. Press the Accept button to save the parameters and
proceed to the next step.
The numeric values of the tunnel length (distance from Epithelial control point to Tunnel
control point), effective tunnel length (sum of distances of each plane making up the tunnel),
corneal thickness are displayed. The angles and the percent depth of cornea for each plane
making up the Primary Incision Pattern are also displayed.
These numeric values are updated as the control points are moved.
The corneal thickness value as determined by setting the Epithelial and Endothelial control
points is also used for the Secondary Incision Pattern.
As the Primary and Secondary Incision Patterns are positioned, the Capsule Position action
button is displayed to allow easy switching between positioning modes.
Press the Accept button when the Primary and Secondary Incision Pattern positioning is
complete. The LenSx Laser System software performs a validation check on the pattern
parameters. An error message is displayed if the parameters are invalid. The parameters must
be corrected before proceeding.
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6.5.9 Arcuate Incision Thickness Adjustments
If an Arcuate Incision Pattern is selected, the Arcuate Thickness action button appears after
pressing the Accept button. Selecting the Arcuate Thickness button initiates an OCT scan of the
corneal region for the arcuate incision. The zoomed image of the Primary Arcuate Incision
pattern is displayed on the top right portion of the Video Microscope display. If the Secondary
Arcuate Incision pattern is enabled, the zoomed image of the Secondary Arcuate Incision area is
displayed on the bottom right portion of the Surgical Display.
Epithelial and Endothelial control points, similar to those in the Primary and Secondary Incision
Patterns above are displayed. The Epithelial control point can only be moved along the dashed
vertical line in Figure XX below. The Endothelial control point is moved along the dashed line
normal to the cornea. As the control points are moved, the numeric value of the distance
between them, representing the corneal thickness, is displayed and updated.
Move the control points to produce the desired cut position and depth. Repeat for both the
Primary and Secondary Arcuate Incision Patterns, if necessary. The corneal thickness value
used is the smaller of the two adjusted thicknesses.
When the Arcuate Incision corneal thickness adjustments are complete, press the Accept
button. The LenSx Laser System software performs a validation check on the pattern
parameters. An error message is displayed if the parameters are invalid. The parameters must
be corrected before proceeding.
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Figure 6‐20: Line OCT guide and corneal thickness adjustments
for Arcuate Incision Patterns. Figure shows Primary Arcuate
Incision and control points (not shown is the Secondary Arcuate
Incision). The control points are adjusted to the desired position
and thickness for the arcuate cuts. Previous View switches to
the last displayed screen. Pressing the Accept button stores the
adjusted values and returns the display to the Pattern
Positioning Screen.
6.6 Confirmation
If all positioning steps have been completed, the Accept All action button is active (See figure 6‐
21 below). Press the Accept All button. A summary of altered pattern parameters will be
shown on the Display Panel. Review the summary and select either Rerun OCT to repeat the
sequence of positioning steps or select Apply to Patient to proceed to treatment.
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Figure 6‐21: Once the pattern positioning process has been
successfully completed, press the Accept All button to begin the
treatment.
6.7 Treatment
After the Accept All button has been selected, treatment is enabled. The Surgical Display shows
a live microscope video image, a line OCT image of the anterior chamber, and a circle OCT
image of the lens and capsule. Graphical outlines of the selected patterns are overlaid on each
of these views. A message is displayed on the Display Panel indicating that the beam scanners
have been moved to the starting position for treatment. The estimated laser treatment time in
seconds is displayed. The Treat button is now enabled.
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Figure 6‐22: Display Panel when system is ready for treatment.
Treat button is enabled and the procedure time is indicated in
the blue progress bar.
Press the Treat button. The treatment dialog window is displayed in the middle of the
Treatment screen. The OCT images are overlaid with progress indicator bars. Initially, these
vertical indicators are unfilled.
When ready to begin treatment, press and hold the footswitch. Releasing the footswitch during
the procedure will immediately halt treatment. Treatment can be resumed by pressing the
footswitch again. During laser treatment, a red laser emission message is shown on the Display
Panel. Procedure progress may be monitored with the following indicators:

vertical progress bars continuously track the progress of each incision

a display of the pattern selections

a display of the estimated remaining procedure time in seconds

a live video camera image of surgical field
During treatment, monitor the surgical progress on the video monitor. If an incorrect pattern
occurs, halt the procedure by releasing the footswitch. The procedure may then be continued.
Alternatively, a traditional cataract surgical procedure may be performed.
In the event of power failure resulting in an interrupted procedure, remove the patient
interface tube from the vacuum port to release the eye from suction. Grasp the delivery
system objective and raise it 1 to 2 inches to safely remove the patient from the surgical field.
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If at any time during the combination procedure the surgeon wishes to halt the procedure, the
footswitch may be released.
Figure 6‐23: Display Panel and Surgical Display during treatment. The OCT images are
overlaid with graphical indicators for the patterns and completion progress bars (lower right
corner of right image).
6.8 Procedure Completion
A message will be displayed indicating the completion of the procedure. The Surgical Display
continues to show a live video image of the eye. The Display Panel returns to the biometrics
screen.
Release the footswitch at this time. Completion of the procedure de‐activates the footswitch
and closes the main laser shutter. Vacuum is automatically halted and the eye is released from
suction. Rotate the joystick on the control panel counter‐clockwise to raise the delivery device
and safely remove the patient from the surgical field. Unlock, remove and discard the Patient
Interface.
Discard the Patient Interface as medical waste.
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7 Calibration and Alignment
Calibration of the LenSx Laser should be performed by trained LenSx personnel. However, the
following internal calibration procedures are available to the user.
7.1 Energy Calibration
The LenSx Laser performs a laser energy calibration during system startup. A user‐requested
calibration can be performed at any time by selecting Energy Calibration in the System Checks
menu. No tools are required. Use of the console is disabled until the calibration has been
completed.
7.2 Beam Steering
The LenSx Laser automatically performs a beam steering check prior to each procedure. This
check ensures that the laser beam is optimally aligned into the delivery system. Users can also
request that this check be performed using the Beam Steering selection in the System Checks
menu.
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8 Service and Maintenance
To ensure continuous operation of the LenSx Laser system, preventive maintenance service
should be made every three months by an authorized LenSx service representative.
Only trained LenSx representatives should perform unpacking, installation, and servicing of the
LenSx Laser. Covers are not to be removed by anyone other than LenSx personnel. Accidental
contact with the high voltage electrical circuits in the interior of the LenSx Laser console may
result in serious injury or death. Ocular exposure to collimated beams contained in the console
interior can produce retinal damage.
The LenSx Laser uses a closed, internal re‐circulating cooling system whose fluid levels are
checked during preventive maintenance. Coolant levels are automatically monitored by the
system and if a low coolant error occurs, a message is displayed. An authorized LenSx service
representative should be called if a coolant error occurs.
The LenSx console is designed for use in a surgical setting. The outer surfaces of the console
may be wiped down with a clean damp cloth if necessary. A mild disinfecting agent may be
used. The console does not require further sterilization.
Accident fluid spills on the delivery system optics may be lightly wiped using an alcohol swab.
The LenSx Laser is designed for use with a LenSx Laser Patient Interface. The Patient Interface
is the only component that contacts the patient. All used Patient Interfaces must be properly
disposed as medical waste.
8.1 Transport and Storage
Contact LenSx representatives to move, transport or store the LenSx Laser. The transport and
storage temperatures should not exceed operating temperature and humidity specifications.
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9 Trouble Shooting
Below is a guide to some possible problems, with the symptoms, possible causes and corrective
actions. If a particular condition is not listed here, it is advised that a LenSx authorized service
representative be contacted for consultation.
Table 9‐A: LenSx Laser – Troubleshooting Guide
Symptom
Possible cause
Corrective action
Laser console does
not startup.
Fuse blown at system real panel
Replace fuse located at the lower rear
panel.
Footswitch is actuated
Release footswitch
Parameters not selected
Enter required fields
System fault has occurred
Contact LenSx representative
Door safety interlock has disabled laser
console
Close operating suite doors, check interlock
connections
Footswitch not connected
Connect footswitch
Footswitch not fully actuated
Completely actuate footswitch
Power cord disconnected
Connect cord
Footswitch not connected
Connect footswitch
Circuit breaker tripped
Reset breaker, check electrical service
System electrical fault
Contact LenSx representative
Laser console will not
proceed to the
treatment stage
Laser console will not
treat when enabled
Laser console will not
energize upon start‐
up
Door safety interlock has disabled laser
Laser beam halts
during treatment
Fixation cannot be
achieved or
maintained
80‐0001
Rev. A
Footswitch not fully actuated
Close operating suite doors, check interlock
connections
Maintain footswitch actuation during
procedure
Fault condition
Contact LenSx representative
Suction not present
Re‐apply suction ring
Suction tubing failure
Replace suction ring
Improper applanation or improper coupling
of the suction ring assemble or applanation
lens
Re‐position delivery system and re‐
applanate cornea.
Patient movement
Immobilize patient
58
LENSX LASER SYSTEM
OPERATOR’S MANUAL
Symptom
Operating field not
properly observable
through microscope
Laser tissue effect not
apparent during
treatment
Possible cause
Corrective action
Applanation lens contaminated
Replace disposable Patient Interface.
Poor illumination or poor focus
Adjust illumination or focus controls.
Microscope optically misaligned
Verify positioning of magnification knob.
Applanation lens contaminated or
damaged
Replace disposable Patient Interface.
Applanation lost or vacuum integrity has
been lost
Reposition suction ring and fixate. Re‐
position delivery system and re‐applanate
cornea.
Laser output blocked
Contact LenSx service representative.
Laser output misaligned
Laser optical malfunction
Applanation lost or vacuum integrity has
been lost resulting in an interrupted
procedure
Procedure incomplete
Laser output blocked
Laser source misaligned
Misaligned beam delivery device
Loss of line power
Treatment geometry
incorrect
80‐0001
Rev. A
x‐y scanning unit failure
Contact LenSx service representative.
Reposition suction ring and fixate. Re‐
position delivery system and re‐applanate
cornea.
Repeat phacofragmentation treatment at
the same centered position and using same
parameters as appropriate.
Repeat capsulotomy treatment at the same
center position and using slightly larger
diameter.
Inspect beam path. Allow 1 hour before
retreatment.
Contact LenSx service representative.
Retreat when LenSx Laser is repaired.
Release the eye from suction. Grasp the
delivery system objective and raise it 1 to 2
inches to safely remove the patient from
the surgical field.
Contact LenSx service representative.
Retreat when LenSx Laser is repaired.
59
LENSX LASER SYSTEM
OPERATOR’S MANUAL
10 Labels
10.1 Console Labels
Warning labels are found on the LenSx Laser to denote specific hazards. Observe label
warnings at all times. The LenSx Laser is labeled in accordance with requirements for all medical
devices as well as with requirements for laser products.
Table 10‐A: Warning Labels used with the LenSx Laser
Label
Label Name
Identification Label
(100 V)
Identification Label
(120 V)
80‐0001
Rev. A
60
LENSX LASER SYSTEM
OPERATOR’S MANUAL
Label
Label Name
Identification Label
(220‐240 V)
Laser Aperture
Protective Housing,
Class 4
Protective Housing,
Class 3B
Surgical Laser Beam Maximum Output: 0.5W
Pulse Duration: <800fs
Emittied Wavelength: 1030nm
IEC 60825-1:2007 Class 3B Laser Device
Laser Warning
Surgical Beam
82-0004 Rev. A
80‐0001
Rev. A
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LENSX LASER SYSTEM
OPERATOR’S MANUAL
Label
Label Name
OCT Laser Beam Maximum Output: 3.0mW
Emittied Wavelength: 820-880nm
IEC 60825-1:2007 Class 3R Laser Device
10 CFR 1040.10 Class 3B Laser Device
OCT Beam
Laser Warning
82-0006 Rev. A
High Voltage
High Voltage (internal)
Emergency Stop
80‐0001
Rev. A
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LENSX LASER SYSTEM
OPERATOR’S MANUAL
11 System Specifications
System Parameter
Laser type
Specifications
Femtosecond Infrared laser
Mode
Fundamental (TEM00)
Cone angle
0.20 sr (± 0.05 sr) half angle
Laser pulse width
600 ‐ 800 fs (± 50 fs)
Central laser wavelength
1030 nm (± 5 nm)
Maximum pulse energy
15 µJ (± 1.5 µJ)
OCT Device
Wavelength 820 – 880 nm (± 5 nm)
3.0 mW (± 0.2 mW) maximum power
Remote interlock
Included in system
Input voltage
Configurable 100V/12A, 120V/10A, 220‐240V/7A,
50/60 Hz
Maximum Electrical Load
≤ 1.2 kW
External Fuse (x2)
3AG, Fast Acting, 250V, 15A
Console dimensions
Console footprint 24” (W) x 30” (L) x 48” (H)
Beam delivery device 8”(W) x 23”(L) x 20”(H)
Beam delivery device height
Min 28.1 inches (floor to applanation lens)
Max 41.7 inches (floor to applanation lens)
Console weight
1055 lbs
Ambient operating temperature
18 °C to 24 °C (65°F to 75°F)
80‐0001
Rev. A
63
LENSX LASER SYSTEM
OPERATOR’S MANUAL
12 Warranty Information
Alcon LenSx Inc. (Alcon LenSx) warrants that the LenSx Laser (the “Equipment”) and software
will conform to the published product specifications of Alcon LenSx and be free from material
defects in materials and workmanship for the first year of continuous service. An Alcon LenSx
service and support contract between Alcon LenSx or an Alcon affiliate and the end user must
be maintained at all times.
Alcon LenSx will repair or replace at no charge any Equipment or software found upon
examination by Alcon LenSx to be defective during the warranty period. This warranty is subject
to the following exclusions, exceptions, and limitations: a) expenses such as labor or other
expenses due to delays or inability to render any service; b) correction of operator problems
related to environmental conditions beyond the control of Alcon LenSx; c) repair and
maintenance necessitated by user‐induced damage, neglect, misuse, or improper operation of
the Equipment or software; d) modification or connection of other equipment to the
Equipment or software without the express written authorization of Alcon LenSx, such
authorization which may be withheld at Alcon LenSx’s sole discretion; e) sublease or use of
Equipment by anyone other than the end‐user's qualified and trained personnel; f) use for any
processes, procedures, experiments, or any other use for which the Equipment is not intended
for use or approved for use by the Food and Drug Administration (FDA); g) supplies, devices, or
electrical work external to the Alcon LenSx Equipment or software; and h) repairs due to the
user's failure to perform any routine maintenance, which is the responsibility of the user.
Alcon LenSx is not responsible and will charge the user for repair, replacement, or maintenance
caused by user‐induced damage, neglect, misuse, improper operation, accident, fire, water,
vandalism, unauthorized equipment attached to the Equipment, or unauthorized modification
of Equipment or software. Warranty does not extend to any Equipment or software not
provided by LenSx.
THE FOREGOING WARRANTY IS IN LIEU OF AND EXCLUDES ALL OTHER EXPRESS OR IMPLIED
WARRANTIES, ARISING BY OPERATION OF LAW OR OTHERWISE, AND NO OTHER
WARRANTIES EXIST, INCLUDING, WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF
MERCHANTABILITY. FURTHERMORE, ALCON LENSX DOES NOT WARRANT THAT THE
OPERATION OF THE SOFTWARE SHALL BE UNINTERRUPTED OR ERROR FREE. IN NO EVENT
WILL ALCON LENSX BE LIABLE FOR ANY INCIDENTAL OR CONSEQUENTIAL DAMAGES,
EXPENSES, LOST PROFITS, OR OTHER DAMAGES ARISING OUT OF THE USE OR INABILITY TO
USE THE EQUIPMENT AND SOFTWARE, EVEN IF ALCON LENSX HAS BEEN ADVISED OF THE
POSSIBILITY OF SUCH DAMAGE.
80‐0001
Rev. A
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LENSX LASER SYSTEM
OPERATOR’S MANUAL
13 Abbreviations and Terms
13.1
General Abbreviations
ANSI
CDRH
DFU
FDA
LED
NOHD
American National Standards Institute
Center for Device and Radiologic Health (FDA)
Directions for Use
Food and Drug Administration (United States)
Light Emitting Diode
Nominal Optical Hazard Zone
13.2
Terms
Applanation:
Femtosecond:
Picosecond:
13.3
flattening of cornea
measure of time; 1 fs = 10‐15 seconds, or 0.000000000000001 seconds
measure of time; 1 ps = 10‐12 seconds, or 0.000000000001 seconds
Symbols
Manufacturer
European Representative
80‐0001
Rev. A
65
LENSX LASER SYSTEM
OPERATOR’S MANUAL
14 Nominal Optical Hazard Distance (NOHD)
The NOHD is defined according to American National Standards Institute Z136.1‐2000,
“American National Standard for Safe Use of Lasers.” The NOHD is computed in terms of the
Maximum Permissible Exposure (MPE) allowed onto the eye. For the LenSx Laser the NOHD
calculated using this standard is very short due to the small pulse energies emitted by the laser.
The practical consequence is that operators and support personnel are not at endangered by
optical radiation normal and routine operation of the laser. Any service operation requiring the
removal of any covers or shields on the console will require eyewear of OD ≥ 5 at a wavelength
of 1030 nm. Only authorized LenSx service representatives should attempt to remove console
covers or to service the LenSx Laser.
The steps required to calculate the NOHD according to Z136.1‐2000 (referred to hereafter as
“the Standard”) are described below. The Standard describes the calculation of MPE according
to three rules and utilizes the prescribed MPE to compute the NOHD.
Rule 1: Single‐pulse MPE
Table 5a of the Standard lists the single‐pulse MPE for a laser of wavelength 1030 nm and a
single pulse exposure of 600 fs as
MPE SP  1.5 C C  10 7 J/cm 2 .
(1)
From Table 5 of the Standard, CC = 1 so that MPESP = 1.5  10‐7 J/cm2. To compute the NOHD,
consider the figure below.

r = rNOHD
Figure 14‐1: Geometry for calculation for possible ocular
This figure is similar to Figure B6 of the Standard. After the focal, light fills a cone of half‐angle
 and illuminates a plane at a distance r. The fluence, F, observed on the surface is
80‐0001
Rev. A
66
LENSX LASER SYSTEM
OPERATOR’S MANUAL
F
 d2
(2)
 2
 r tan2 
Here E is the maximum energy delivered by a single pulse. The NOHD is computed by replacing
the fluence with the MPESP derived above and solving for r.

 2
rNOHD  
2 
  (MPESP )tan  
(3)
For the LenSx Laser, the maximum emitted energy is 15 µJ and θ = is 14.5°. The resulting NOHD
using Rule 1 is 21.8 cm.
Rule 2: Average Power MPE for Thermal and Photochemical Hazards
According to Table 5a of the Standard, the average power, MPE for an exposure of 10 s is
MPE AVG  C C  10 3 W/cm 2 where C C  10 2(   0.700). .
(4)
Using λ = 1.030 mm, the average power MPE is MPEAVG = 4.57  10‐3 W/cm2. In order to
compute the NOHD, consider the figure used in Rule 1 and compute the irradiance as follows:
PAVG
 d2
 2 AVG 2 .
 r tan 
I
(5)
The NOHD is computed by replacing the irradiance with the MPEAVG in (5) and solving
for r.

 2
PAVG
rNOHD  
2 
  (MPEAVG )tan  
(6)
For the LenSx Laser, the average maximum power of the laser is 500 mW at 33 kHz and θ = is
14.5°. The resulting NOHD using Rule 2 is 22.8 cm.
Rule 3: Multiple‐pulse MPE for Thermal Hazards
Section 8.2.3 of the Standard defines the MPE for this rule as, MPE / pulse  MPESP  CP ,
where MPESP is computed from (1), and CP = n–1/4 where n is number of pulses emitted during a
10 s exposure. During a 10 s exposure of the LenSx Laser:
80‐0001
Rev. A
67
LENSX LASER SYSTEM
OPERATOR’S MANUAL
n = 3.3  105;
CP = 0.042;
MPEMULT = 6.30  10‐9 J/cm2.
The NOHD is computed by replacing MPESP in equation (3) with MPEMULT. The resulting NOHD
using Rule 3 is 106 cm.
Since Rule 3 provides the most conservative values of NOHD, the reported nominal optical
hazard distance is 106 cm for the LenSx Laser.
80‐0001
Rev. A
68
LENSX LASER SYSTEM
OPERATOR’S MANUAL
15 Declaration of Compliance
Guidance and manufacturer’s declaration – electromagnetic emissions
The LenSx Laser System is intended for use in the electromagnetic environment specified below. The customer
or the user of the LenSx Laser should assure that it is used in such an environment.
Emissions test
RF emissions
Compliance
Class A
CISPR 11
IEC 60601‐1‐2
Electromagnetic environment ‐ guidance
The LenSx Laser System uses RF energy for its internal function
and an RFID device for detection of a valid Patient Interface.
The RFID is a low power single frequency device that complies
with FCC and international standards for intentional
transmitters. Therefore, its RF emissions are low and are not
likely to cause any interference in nearby electronic equipment.
This device complies with 47 CRF 15 Federal Communications
Commission Rules (FCC) for radio frequency devices. (1) The
LenSx Laser does not cause harmful interference, and (2) this
device must accept any interference received, including
interference that may cause undesired operation.
Changes or modifications not expressly approved by Alcon
LenSx Inc. can void the user’s authority to operate this device.
Conducted emissions
Class A
CISPR 11
IEC 60601‐1‐2
Harmonic emissions
Class A
IEC 61000‐3‐2
Voltage fluctuations / flicker
emissions
The LenSx Laser System is suitable for use in all establishments
other than those directly connected to the public low‐voltage
power supply network that supplies buildings used for
domestic purposes.
Complies
IEC 61000‐3‐3
80‐0001
Rev. A
69
LENSX LASER SYSTEM
OPERATOR’S MANUAL
Guidance and manufacturer’s declaration – electromagnetic immunity
The LenSx Laser System is intended for use in the electromagnetic environment specified below. The customer
or the user of the LenSx Laser System should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment ‐ guidance
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.
Electrostatic
discharge (ESD)
IEC 61000‐4‐2
± 6 kV contact
± 8 kV
± 6 kV contact
± 8 kV
Radiated EM
Field
Range
Range
80 MHz – 2.5 GHz
80 MHz – 2.5 GHz
IEC 61000‐4‐3
3 V/m
3 V/m
± 2 kV for power
supply lines
± 2 kV for power
supply lines
IEC 61000‐4‐4
± 1 kV for input /
output lines
± 1 kV for input /
output lines
Surge Immunity
± 1 kV differential
mode
± 1 kV differential
mode
± 2 kV common mode
± 2 kV common mode
Conducted
Disturbances
Range
Range
0.15 – 80 MHz
0.15 – 80 MHz
IEC 61000‐4‐6
3(VRMS)
3(VRMS)
Electrical fast
transient / burst
IEC 61000‐4‐5
Power frequency
(50/60 Hz)
magnetic field
Immunity
IEC 61000‐4‐8
80‐0001
Rev. A
3 A/m
3 A/m
Operator Display Panel demonstrated
susceptibility to ESD at 4 kV (and above)
when applied to the metal arm and metal
mount brackets at the rear of the
monitor assembly. The susceptibility
results in transient flicker of the display
monitor. Performance and safety are not
affected.
Electro‐Magnetic fields should be at
levels characteristic of a typical location
in a typical commercial or hospital
environment.
Do not use cell phones, pagers, or radio
frequency devices of any kind in the
same room as the LenSx Laser.
Mains power quality should be that of a
typical commercial or hospital
environment.
Mains power quality should be that of a
typical commercial or hospital
environment.
Mains power quality should be that of a
typical commercial or hospital
environment.
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or
hospital environment.
70
LENSX LASER SYSTEM
OPERATOR’S MANUAL
Guidance and manufacturer’s declaration – electromagnetic immunity
The LenSx Laser System is intended for use in the electromagnetic environment specified below. The customer
or the user of the LenSx Laser System should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment ‐ guidance
Dips
Dips
>95% for 10ms
>95% for 10ms
Mains power quality should be that of a
typical commercial or hospital
environment.
‐60% for 1000ms
‐60% for 1000ms
Voltage dips,
Interruptions &
Fluctuations
‐30% for 500ms
‐30% for 500ms
Interruptions
Interruptions
IEC 61000‐4‐11
>95% for 5 sec
>95% for 5 sec
Fluctuations
Fluctuations
UNOM + 10% 15 min
UNOM + 10% 15 min
UNOM – 10% 15 min
UNOM – 10% 15 min
It is a requirement that the user powers
the Alcon LenSx Laser System with a UPS.
The UPS must have enough back‐up
capacity for a minimum of 5 minutes at
system full load. The rating for the UPS
should be a minimum of 1400 Watts
NOTE: UNOM is the A.C. mains voltage prior to application of the test level
80‐0001
Rev. A
71

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