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Operator's Manual - YAG Laser SeLecTor Deux
Operator's Manual - YAG Laser SeLecTor Deux
Operator's Manual - YAG Laser SeLecTor Deux
For The
2460
Directive 93/42/EEC
Doc. No.: YL0416
Rev. No.: 06
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 2 of 85
Operator’s Manual
for the Ophthalmic YAG Laser, SeLecTor Deux.
Clinicians and/or Doctors should ensure that they are adequately knowledgeable of the operation or
training prior to using the SeLecTor Deux laser equipment.
This Operator's Manual should be studied and understood before proceeding to operate the equipment on
patients.
CAUTION!
The use of controls or adjustments or performance of procedures other than those specified herein may
result in hazardous radiation exposure!
United States Federal Law restricts this device to be sold by or on the order of a physician!
This Operator's Manual contains confidential and proprietary information of the Manufacturer.
Manufactured by: LIGHTMED Corporation, No.1-1, Lane 1, Sec. 3, Pao An St., Shulin
District, New Taipei City 23861, Taiwan
____________________________________________________________________________
EU Representative: Medical Device Safety Service GmbH Schiffgraben 41, 30175 Hannover, Germany
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 3 of 85
____________________________________________________________________________
Document Title: Operator’s Manual for the Ophthalmic YAG Laser, SeLecTor Deux.
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 4 of 85
Table of Contents
Section 1 Introduction ............................................................................................................................. 8
Section 2 Safety....................................................................................................................................... 9
2.1 Product Classifications ................................................................................................................ 9
2.2 Warnings and Precautions ......................................................................................................... 10
2.3 Optical Hazards ......................................................................................................................... 11
2.3.1 Nominal Ocular Hazard Distance (NOHD) .......................................................................... 11
2.3.2 Avoid Exposure to Laser Beams ........................................................................................... 12
2.4 Electrical Hazards ...................................................................................................................... 12
2.5 Safety Controls and Features ..................................................................................................... 12
2.6 Product Labeling ....................................................................................................................... 15
Section 3 Product Specifications ........................................................................................................... 18
3.1 General Specifications ............................................................................................................... 18
3.2 Treatment Laser Specifications ................................................................................................. 19
3.3 Aiming Laser Specifications ..................................................................................................... 20
3.4 Safety Filter Specifications ........................................................................................................ 20
3.5 Slit Lamp Specifications ............................................................................................................ 21
Section 4 Principles of Operation.......................................................................................................... 22
4.1 General Description ................................................................................................................... 22
4.1.1 YAG Mode: Ophthalmic YAG Laser 1064 nm .................................................................... 22
4.1.2 SLT Mode: Frequency-Doubled YAG Laser 532 nm ........................................................... 24
4.2 Laser System Operation............................................................................................................. 25
4.3 YAG Laser Controls .................................................................................................................. 27
4.3.1 Front View Controls .............................................................................................................. 27
4.3.2 Side View Controls ............................................................................................................... 31
Section 5 Installation ............................................................................................................................. 33
5.1 Introduction and Requirements ................................................................................................. 33
5.2 Requirements Prior to Installation ............................................................................................. 33
5.3 Unpacking and Receiving Inspection ........................................................................................ 34
5.4 Tools and Equipment ................................................................................................................. 37
5.5 Installation Process .................................................................................................................... 38
5.6 System Verification ................................................................................................................... 46
5.6.1 Minimum Air Breakdown Energy......................................................................................... 46
5.6.2 Optical Alignment ................................................................................................................. 47
5.6.3 Output Energy Calibration .................................................................................................... 48
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 5 of 85
LIGHTMED SeLecTor Deux Service Report ........................................................................................ 49
Section 6 Clinical Use ........................................................................................................................... 55
6.1 Posterior Capsulotomy (YAG) .................................................................................................. 56
6.2 Pupillary Membranectomy (YAG) ............................................................................................ 60
6.3 Iridotomy (YAG) ....................................................................................................................... 60
6.4 Selective Laser Trabeculoplasty (SLT) ..................................................................................... 64
Section 7 Troubleshooting .................................................................................................................... 66
7.1 Error Symptoms......................................................................................................................... 66
7.2 Error Codes................................................................................................................................ 67
Section 8 Electromagnetic Compatibility (EMC) Test ......................................................................... 70
Section 9 User Maintenance.................................................................................................................. 74
Section 10 Warranty Details and Conditions .......................................................................................... 75
Section 11 EMC Test Tables................................................................................................................... 76
Appendix I Optional Accessories ....................................................................................................... 80
Appendix II Glossary ........................................................................................................................... 81
Appendix III References ................................................................................................................... 83
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 6 of 85
List of Drawings / Figures
Figure 1 Safety controls and features. ......................................................................................... 12
Figure 2 Product safety labels. .................................................................................................... 15
Figure 3 YAG laser focusing for treatment................................................................................. 23
Figure 4 YAG laser controls (front view). .................................................................................. 27
Figure 5 YAG laser controls (side view). ................................................................................... 31
Figure 6 Packing carton .............................................................................................................. 34
Figure 7 Portable carrying case. .................................................................................................. 34
Figure 8 Packing carton _ top layer ............................................................................................ 35
Figure 9 Packing carton _ middle layer ...................................................................................... 35
Figure 10 Packing carton _ middle layer _ package 1 ................................................................ 36
Figure 11 Packing carton _ middle layer _ package 2 ................................................................ 36
Figure 12 Packing carton _ bottom layer .................................................................................... 37
Figure 13 Install the cross slide shaft and gears (1) .................................................................... 38
Figure 14 Install the cross slide shaft and gears (2) .................................................................... 38
Figure 15 Install the slitlamp and Laser to the control box (1) ................................................... 39
Figure 16 Install the slitlamp and Laser to the control box (2) ................................................... 39
Figure 17 Install the slitlamp and Laser to the control box (3) ................................................... 40
Figure 18 Install the slitlamp and Laser to the control box (4) ................................................... 40
Figure 19 cable connection (1).................................................................................................... 41
Figure 20 cable connection (2).................................................................................................... 41
Figure 21 Install the cover for plastic rail ................................................................................... 42
Figure 22 Install the chinrest and the wire plate (1).................................................................... 42
Figure 23 Install the chinrest and the wire plate (2).................................................................... 43
Figure 24 Install the chinrest and the wire plate (3).................................................................... 43
Figure 25 Install the binocular to the instrument ........................................................................ 43
Figure 26 Positioning the Slitlamp Cables Figure ...................................................................... 44
Figure 27 Side view of the SeLecTor Deux assembly ............................................................... 44
Figure 28 The correct positioning of the 2 slit lamp cables ........................................................ 45
Figure 29 Final assembly of the SeLecTor Deux laser system ................................................... 45
Figure 30 Putting 2 red aiming beams together as one. .............................................................. 47
Figure 31 YAG burn mark aligned to the merged aiming beams and illumination spot. ........... 48
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 7 of 85
Section 1 Introduction
This manual is intended to provide the Operator with an overview of the operation and safety requirements
for the SeLecTor Deux Ophthalmic Laser. This manual is not intended to provide instructions on actual
treatment procedures, and it is expected that users will have undertaken training prior to using the equipment.
Caution has been taken into consideration in the preparation and revision of this Manual. However, there
is no guarantee that all information written here will be accurate. The information provided in this Manual
is subject to change without notice.
Only approved or authorized accessories may be used with this laser system. The Manufacturer and
Distributor organization shall not be held liable or responsible for damages or injury caused as a result of
using unapproved accessories.
All maintenance and service work must be carried out by authorized and trained Service Technicians and
only those procedures outlined in the Operator’s and Service Manual are allowed. Any service work carried
out by unauthorized persons will void all warranties.
No circuit diagrams or component part lists are to be provided for this laser system. If you require any
technical documentation that is not provided in this manual, please contact the Manufacturer or your local
distributor, in writing, with your reasons for requesting them and only then a copy of the Service Manual
may be provided.
Before using the SeLecTor Deux Ophthalmic Laser system, the operator should read this manual carefully
and pay attention to the sections of safety, operation, and maintenance.
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 8 of 85
Section 2 Safety
This laser system has been designed and tested to function in a safe and correct operation when used as
indicated in this manual. Do not use this laser without reading and completely understanding this Operator’s
Manual. It is important to remember that this laser emits high levels of visible and invisible laser radiation,
which can cause permanent and irreparable eye and tissue damages. Always observe precautions for laser
safety including using warning signs, safety glasses, and only operating the laser in a treatment room that
provides protection to casual observers.
Standards Description
EN 60825-1:2007
USA 21 CFR 1040.10, 1040.11 (1997)
Laser
EN 60601-2-22:2013
IEC 60601-2-22:2007+A1:2012
IEC 60601-1 2005+CORR.1:2006+CORR.2:2007+A1:2012
EN 60601-1: 2006+A11:2011+A1:2013+A12:2014
Electrical EN 60601-1-2:2015
USA UL2601
JIS T1001 (1992) and T1002 (1992)
MDD 93/42/EEC (as amended by 2007/47/EC)
EN 60601-1-6:2010
IEC 60601-1-6 :2010
EN 62366 :2008
Others
IEC 62366:2007
ISO 14971:2012
ISO 15223-1:2016
ISO 13485:2016
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 9 of 85
2.2 Warnings and Precautions
The following warnings and precautions apply to the SeLecTor Deux Ophthalmic Laser system and should
be observed by all users at all time:
DO NOT look directly into or at the laser beam or at specular laser reflections since direct and
reflected laser light from the laser aperture can cause permanent eye injury.
DO NOT operate the laser unless observers are using the correct protective eyewear that has an
optical density of OD4 at 1064 and 532 nm to accommodate this laser system. The OD information
must be visible on the eyewear.
DO NOT use objects that can readily reflect light in the vicinity of the laser beam to avoid reflecting
the beam in a hazardous manner.
DO NOT fire the laser directly onto flammable agents or gasses as the focused laser beam may
cause ignition. There is no AP/ APG protection.
DO NOT try to service or repair the laser other than what is included in this manual. Service should
only be performed by authorized and trained technicians.
DO NOT fire the laser on patients without checking the operation of the laser and verifying the
optical alignment of the laser treatment beam.
ALWAYS use the lowest energy settings possible when treating patients and start the treatment
with minimum energy setting.
ALWAYS use the most appropriate energy setting for the type of procedure to be performed.
DO NOT put the laser into TREAT mode until ready to operate on the patient.
DO NOT inhale any laser plume generated by the laser during surgery. Personnel should take
precautions, such as wearing surgical masks or use plume evacuation systems, when a treatment is
undergoing.
o Caution! Laser plume may contain viable tissue particulates.
ALWAYS make sure the Laser has its own dedicated power outlet. Additional items may be
plugged in a Multiple Portable Socket Outlet, which may be plugged into an additional outlet.
DO NOT use the Laser system if the ambient temperature is outside the range of 20 to 40°C, which
is the rated operating temperature limits where the Laser system can be guaranteed to operate
without any interruptions. Outside this range of temperature, it is possible for the Laser to generate
an error condition where a message is displayed, and the system goes into STANDBY mode until
the internal temperature returns to normal limits. Only then the Laser can be used again but the
error condition may reoccur unless the rated temperature comes within limits.
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 10 of 85
2.3 Optical Hazards
The guidance for the safe use of Lasers and Laser systems can be found in Standards IEC 60825-1, USA
21 CFR 1040.10 and 1040.11, as well as ANSI Z136.1-1986. During normal operations of the SeLecTor
Deux Laser, the operator is protected from Laser hazards by built-in optical absorption Safety Filters. All
other personnel in the area should wear protective eyewear to eliminate the risk of eye injury occurring.
The optical density (OD) of eye protection must be at least 4 and the wavelengths of 1064 and 532
nanometers (nm) are also specified on it. The safety glasses specifications are typically shown in this format:
OD4+ @ 1064 / 532 nm
Otherwise, the safety glasses are NOT suitable for eye protection purposes that meet the standard
requirements of this laser. Safety glasses are required to have the CE mark if used in the European Union.
The SeLecTor Deux laser uses a Class I Laser Diode Aiming beam. Its wavelength is 635 nm and the
maximum power output (to be delivered to the patient’s cornea) is set at the factory to be less than 200
microwatts (µW) (< 200 µW), which is less than the maximum safe power that can be visualized by the
retina is 390 µW. It is recommended to use the lowest aiming beam intensity during treatment. This laser’s
classification as Class IIIB is also based on the Accessible Emission Limits (AEL), as mentioned in the
standards above, assuming the laser beam energy is delivered through a dilated pupil of diameter 7
millimeter (mm) to the posterior capsule surface in the eye. The maximum energy allowed for a Class IIIB
laser operation is shown below. These limits are calculated according to the CFR 21 regulations as their
AELs are lower than the IEC 60825. The product then complies to both requirements.
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 11 of 85
2.3.2 Avoid Exposure to Laser Beams
Reassembly or maintenance of the laser system should only be performed by authorized and trained
personnel. The external housing of the laser system should never be removed. Otherwise, the user and/or
observers could be exposed to dangerous levels of laser radiation and potentially lethal electrical voltages.
For other personnel that may be exposed to reflections or backscatter, they must wear safety glasses or
goggles. In any case, NEVER look directly at the treatment laser beam as severe eye injury is likely to
occur. Avoid looking into the laser aperture.
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 12 of 85
No. Item Description
Provides a manual immediate shutdown of the entire laser system in the event
of an emergency or irregular behavior of the laser system. It has a bright red
Emergency stop
1 button that locks down when pressed, where all power is cut off from the
button
internal components. To restore power to the system, rotate the red button in
the direction stated on the button label.
Rotating the key in a clockwise direction would turn the device ON. When
2 Key switch the key is in the ON position, the key cannot be removed. The key should be
stored in a safe, controlled place when the device is not in use.
Power ON The green light located next to the key switch indicates that when
3
indicator illuminated, the power is being supplied to the system.
With the key switch in the ON position, pressing this button for at least 0.5
seconds would turn the laser ON, thus illuminating after approximately a 7-
“LASER POWER” second delay, allowing for laser emissions to be possible. Power is
4
ON/OFF button immediately removed when the button is pushed to turn OFF. By default,
whenever power is supplied to the system, this button will be in the OFF state
(not illuminated).
The green light located next to the “LASER POWER” ON/OFF button
“LASER POWER”
5 indicates that when illuminated, the power is being supplied to the laser
ON indicator
electronics.
A mechanical shutter is kept in the closed position by a spring under tension.
The shutter blocks the treatment laser beam path unless the system is on
Shutter adjuster TREAT mode and the fire button is pressed. At this point, the shutter
6 (inside front panel momentarily opens for less than 100 milliseconds (ms) to allow the treatment
housing) laser beam pulse through and then the shutter closes. At all times, the shutter
position is detected by 2 sensors which are continuously monitored by the
microprocessor.
This button toggles the laser system between STANDBY and TREAT modes.
In STANDBY mode, the laser cannot be fired by the joystick fire button and
7 Mode Set button
the shutter is always closed. The TREAT mode is the only mode that will
allow external laser emissions.
STANDBY mode When this indicator is illuminated, the laser system is set to STANDBY mode
8
indicator where no external laser emission will be delivered.
When this indicator is illuminated, the laser system is in TREAT mode and
TREAT mode the laser energy can be delivered to the patient. If the laser system is not
9
indicator operated for a period of 5 minutes, the laser system will automatically toggle
to STANDBY mode.
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 13 of 85
On the rear side of the control box, there is a connector from which 2 wires
can be wired to a switch on the door of the treatment room so that the switch
goes into open circuit when the door is opened during treatment. When the
circuit connection is broken by opening the door, an audible warning tone
Remote door
10 can be heard, and the laser system will toggle to STANDBY mode to prevent
interlock
laser from firing. This feature can be independently installed by the user, if
necessary. The Manufacturer supplies an equivalent connector with the 2
pins shorted so that the laser will function normally if the remote door
interlock feature is not utilized.
Pressing this button in either STANDBY or TREAT mode will fire the laser
“TEST” Fire
11 but keep the shutter closed. This provides the user a safe way to check the
button
laser’s output energy. The updated energy is shown on the display panel.
When the energy control or the number of pulses is changed, the laser system
“TEST” Fire
12 performs an automatic test fire to verify the new energy level. The energy is
display
then displayed on the display panel.
Whenever the energy control is adjusted or the number of pulses is changed,
Joystick fire
13 the laser system performs an automatic test fire to verify the new energy
button checks
level. The energy is shown on the display panel.
In addition to these safety features, there are also several features that have been built-in to the SeLecTor
Deux laser system:
When the SeLecTor Deux laser is first turned on, the microprocessor performs various checks to ensure
that the laser is functioning properly, then it displays the software version. If the self-check test passes,
then the energy of the most recent laser shot is displayed, and the device goes into STANDBY mode. If
the microcontroller detects that the laser system requires a voltage calibration, then it will automatically
start this test, where the display panel shows “CAL” and it will take approximately 10 minutes to
complete. If problems are detected during self-checks, the laser system will display a corresponding
error message.
The microprocessor monitors the signal from the joystick fire button in order to verify that the button
contact is good. If the joystick fire button is held down for more than one second in TREAT mode, the
system will automatically go into STANDBY mode. Also, it is not possible to go from STANDBY to
TREAT mode if the fire button is pressed in STANDBY mode.
All the safety controls are in place to prevent the operator from unintentionally firing the laser.
This laser system is equipped with protective housing covers to prevent exposure to laser emissions.
Special tools are required to remove the housing covers and only authorized and trained Service
Technicians are permitted to remove them.
There are optical safety filters built into the laser system, which eliminate both 1064 and 532 nm laser
beams, to protect the operator’s eyes from being exposed to the laser beam when using the equipment.
This laser system is designed to comply with the electrical safety standards for ground connections and
ground leakages.
If the laser system is not used or no controls are operated for 5 minutes, the system will go into
STANDBY mode.
The laser system produces an audible warning sound when:
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 14 of 85
o Any of the buttons on the display panel is pressed.
o The remote interlock connection is removed or not properly secured to the back of the control box
upon system start-up.
o The laser is fired using the joystick fire button in TREAT mode.
o The delivered laser energy changes more than ±20% from the previously delivered laser shots. The
audible warning sound indicates that the energy levels need to be checked or re-calibrated.
o The laser goes through self-tests upon system start-up or when the energy or pulses are changed.
o The joystick fire button is held down for more than one second in TREAT mode, resulting in the
system to go into STANDBY mode.
NOTE: With these controls and safety features, the SeLecTor Deux laser system is a very safe instrument
when used correctly and as indicated in this manual.
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 15 of 85
Item Description
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 16 of 85
Conformité Européene or European Conformity.
Indicates Manufacturer declaration that the product
complies with the essential requirements of the
relevant European health, safety, and
environmental protection legislation as per
93/42/EEC, Article 17.
Protective ground.
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 17 of 85
Section 3 Product Specifications
Item Description
100 to 240 VAC
Electrical input 50/60 Hz
Single phase
Power 200 VAC
T3.15 AH250V @ 100 to 120 VAC (time lag)
Fuse rating
T2.5 AH250V @ 200 to 240 VAC (time lag)
Temperature Relative Atmospheric
Item
Range (°C) Humidity Range Pressure (mbar)
Transport,
Operating, and 30 to 85% non-
Operating 20 to 40 800 to 1,060
Storage condensing
Requirements Transport -10 to 70 Up to 95% non-
500 to 1,060
Storage -10 to 55 condensing
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 18 of 85
3.2 Treatment Laser Specifications
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 19 of 85
3.3 Aiming Laser Specifications
Item Description
Safety filter OD4 @ 1064 / 532 nm
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 20 of 85
3.5 Slit Lamp Specifications
Item Description
Model CSO SL950 slit lamp
Microscope Galilean
Magnification set 3-step or 5-step drum rotation
Eyepiece 12.5X
8X, 14X, 25X
Magnification ratio
5X, 8X, 14X, 25X, 38X (optional)
PD range 55 to 75 mm
Diopter adjustment ± 8D
Real fields of view 5.2 to 40 mm
Slit illumination LED XLamp® XM-L2 2.85V 10W
Slit width 0 to 13 mm
Slit length 2 to 12.5 mm
0.3 mm
6 mm
Slit apertures 10 mm
13 mm
Continuous
Slit angles 0° to 180°
Cobalt Blue
Red
Filters
Green (red-free)
Heat-absorbing
Illumination intensity 0 to 60,000 Lux
Item Movement Range (mm)
Longitudinal (in/out) 90
Movement ranges Lateral (left/right) 105
Vertical (up/down) 30
Chinrest Range 80
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 21 of 85
Section 4 Principles of Operation
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 22 of 85
Once the laser is in TREAT mode, the user typically focuses the laser by correctly positioning the aiming
beams on the posterior surface of the capsule. The joystick is then used to fire the laser (putting a hole in
the capsule). Several laser shots would normally be required in order to produce a large enough hole in the
posterior capsule in order to give a clearer vision for the patient. Refer to Section 6 Clinical Use in this
manual for more clinical information.
This laser system console generates a controlled YAG beam of 1064 nm wavelength light that is focused
into a small spot to be delivered via a slit lamp. The laser beam has a spot size of approximately 8 µm and
its energy is adjustable and selected by the user.
The focused YAG laser energy will create a small plasma effect, or spark, in the eye media, which, in turn,
causes an acoustic wave that can disrupt or create a hole in the adjacent tissue. This is commonly called the
opto-acoustic effect.
The size of the plasma effect is directly proportional to the amount of energy in the focused YAG laser
beam. Therefore, as the energy is increased, the plasma will also increase, which then generates a stronger,
more powerful acoustic wave that can make larger holes in the tissue. This acoustic wave can also damage
the intraocular lens (IOL) if the plasma effect is focused too close to the IOL. To prevent this, it is important
to focus the laser beam more posterior or further away from the tissue that is to be disrupted when increasing
the laser energy. This avoids damaging the IOL as well as giving the best and most effective disruption
effect on the tissue. When the laser energy is reduced, then the effect is the reverse of the above, so the
focus needs to be brought closer to the tissue.
In this SeLecTor Deux laser system, the YAG treatment laser beam is normally defocused posterior to the
aiming beams (slit lamp focal plane) by a fixed distance. This distance has been set to provide the optimum
tissue effect at energies of 1.0 to 1.5 mJ, which is the typical setting for posterior capsulotomy procedures.
The YAG treatment laser beam focus is adjustable by an offset dial that is located on the left-hand side of
the laser arm. This YAG offset dial is calibrated in micron or micrometer, µm. The focus can be set by the
user to the most appropriate offset setting according to the energy and procedure that is being carried out.
The posterior (+) offset sets the YAG laser treatment beam posterior, or behind the aiming beams (slit lamp
focal plane), by the settings indicated on the offset dial. The anterior (-) offset sets the YAG laser treatment
beam anterior, or in front of the aiming beams (slit lamp focal plane). As a guide, for posterior capsulotomy
procedures, the offset should be set to around +150 µm for energies between 1.0 to 1.5 mJ. As the energy
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 23 of 85
is increased, the offset should be increased accordingly. It is recommended that the user always start with
a lower energy setting and larger offset to avoid damaging the IOL. A larger offset means that there is less
effect on the capsule surface.
The YAG treatment laser beam is invisible to the human eye, so a visible red aiming beam is used to allow
precise positioning of the treatment laser beam. The aiming beam system originates from a red laser diode
that is split into two collimated beams, which are then focused such that they are parfocal to the slit lamp
and coaxial with the treatment laser beam. Therefore, the 2 aiming beams focus when they are merged
exactly at the focal plane for the slit lamp, which means the 2 aiming beams and YAG treatment laser beam
share the same center point at the focal plane of the slit lamp. The intensity of the aiming beams is set by
the small knob labeled “AIMING INTENSITY” on the right-hand side of the slit lamp arm near the display
panel.
NOTE: It is recommended that the lowest effective YAG treatment laser energy be used to perform opto-
acoustic procedures as a means of minimizing unwanted side effects such as IOL or retinal damages.
Always start the procedure at the minimum energy. Also, a larger YAG offset focus may reduce the
likelihood of IOL damage. Refer to Section 6 Clinical Use in this manual for further information.
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 24 of 85
4.2 Laser System Operation
This system consists of two major parts, as described below:
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 25 of 85
There is a shutter module equipped in the laser system, which completely blocks the laser beam
path, except when the system is in TREAT mode and the joystick is pressed, to ensure that the
patient is protected against misfiring. The microprocessor constantly monitors the electronic
sensor’s position and the integrity of the shutter. When the system boots up, it will check the
shutter position to validate if the shutter is engaged and functional. The position of the shutter
will be continuously checked during all operating modes.
5. Once the self-tests are completed, the system automatically goes into YAG in STANDBY mode by
default. The system will also automatically be in single pulse mode by default.to change to SLT
mode, press the “MODE” button. There will be 1 automatic internal test shot, and then the SLT
LED indicator would illuminate if no errors detected. The system automatically performs 1
automatic internal test shot and then stays in STANDBY condition when it is switched from YAG
to SLT modes, and vice versa.
6. When the laser is turned ON, it automatically goes into STANDBY mode to prevent any accidental
firing of the selected laser wavelength. In STANDBY mode,
The joystick fire button is also automatically disabled, and the shutter module is engaged to
block the beam path so that the YAG or SLT laser energy cannot be delivered from the
objective lens.
The controls on the laser arm and control box, except for the joystick fire button, can be
adjusted appropriate for the intended procedure. Whenever the treatment laser type (YAG or
SLT mode), pulse mode, or energy is changed, the laser will perform a test fire. It is
recommended to always start YAG procedures at the minimum energy setting with a large
YAG offset focus to minimize unwanted side effects to the patient.
7. Prior to activating the TREAT button, it is recommended that all operating conditions, such as
patient positioning, treatment laser type (YAG or SLT), energy selection, pulses, aiming beam and
illumination intensities, YAG offset, air breakdown check as well as optical alignment, are
correctly set. Refer to the Section 5 Installation in this manual for the procedures for the air
breakdown check and optical alignment. This will prevent the likelihood of accidental firing of the
laser or unintentional laser delivery during the treatment session preparation stage.
8. When the TREAT button is pressed, the system goes into treat mode, which activates the joystick
fire button while disengaging the shutter module, allowing the laser treatment and aiming beams to
pass through. The system goes through self-test and after the shutter is verified, the laser system
will be enabled. There is a closed loop control system to ensure a stable output pulse. The laser
beam will only be delivered to the objective lens when the joystick fire button is pressed. The
joystick fire button must be released in order to fire the laser again after the first shot.
9. The system will automatically return to STANDBY mode when:
No controls are operated for 5 minutes, or
Any warning or error messages occur.
10. Turn the key switch in the OFF position and remove the key to turn the system OFF.
11. In the case of an emergency, the red emergency button should be pressed, and it will automatically
cut off all power to the system. Normally, the power can be turned OFF by pressing the “LASER
POWER” button on the control box or by turning the key switch in the OFF position.
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 26 of 85
The user is expected to be trained and possess knowledge in the intended use and application of the laser
system in any surgical treatment sessions. On top of that, the laser system must be used in a clean and
controlled environment. European National Requirements may apply in some EU countries and are to be
observed by those related users.
Depending on the type of procedure performed and the condition of the patient, the user must decide on the
modality of the laser user and whether an assistant is required during the treatment session.
As the laser system is designed to deliver the laser beam to transfer heat to the tissue, care must be taken to
avoid dangerous situations that could cause fire or explosion. The laser should not be fired in the direction
of flammable gases or liquids, which may be present in the operating room.
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 27 of 85
No. Item Description
Provides a manual immediate shutdown of the entire laser system in the event
of an emergency or irregular behavior of the laser system. It has a bright red
Emergency stop
1 button that locks down when pressed, where all power is cut off from the
button
internal components. To restore power to the system, rotate the red button in
the direction stated on the button label.
Rotating the key in a clockwise direction would turn the device ON. When
2 Key switch the key is in the ON position, the key cannot be removed. The key should be
stored in a safe, controlled place when the device is not in use.
Power ON The green light located next to the key switch indicates that when illuminated,
3
indicator the power is being supplied to the system.
With the key switch in the ON position, pressing this button for at least 0.5
“LASER seconds would turn the laser ON, thus illuminating after approximately a 7-
POWER” second delay, allowing for laser emissions to be possible. Power is
4
immediately removed when the button is pushed to turn OFF. By default,
ON/OFF button whenever power is supplied to the system, this button will be in the OFF state
(not illuminated).
“LASER The green light located next to the “LASER POWER” ON/OFF button
5 POWER” ON indicates that when illuminated, the power is being supplied to the laser
indicator electronics.
This button toggles the laser system between STANDBY and TREAT modes.
“SET MODE” In STANDBY mode, the laser cannot be fired by the joystick fire button and
6
button the shutter is always closed. The TREAT mode is the only mode that will
allow external laser emissions.
When this indicator is illuminated, the laser system is set to STANDBY mode
where the shutter is disabled, and no external laser emission will be delivered.
STANDBY mode
7 The laser can be tested with the “TEST” button (#9). However, the shutter
indicator
always remains closed during this test. All controls can be operated in this
mode, except for the joystick fire button.
When this indicator is illuminated, the laser system is in TREAT mode where
the shutter is open, and the laser energy can be delivered to the patient. All
TREAT mode
8 controls can be operated in this mode, including the joystick fire button. If
indicator
the laser system is not operated for a period of 5 minutes, the laser system
will automatically toggle to STANDBY mode.
Pressing this button in either STANDBY or TREAT mode will fire the laser
“TEST” Fire but keep the shutter closed. This provides the user a safe way to check the
9
button laser’s output energy whilst the shutter remains closed. The updated energy
is shown on the display panel.
This button toggles between the number of pulses, ranging from 1 to 3, that
the laser will deliver in burst mode. When the laser is first turned ON, only 1
“SET PULSES”
10 (single) pulse mode is selected by default. When the pulse mode is changed,
button
the laser performs a test fire to measure and display the new energy level.
The number of selected is also displayed on the “PULSES” display.
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 28 of 85
This LED indicates the number of pulses that will be delivered when the YAG
laser is fired. This is also a photodiode that is connected to the same PCB as
the energy meter and allows the number of pulses delivered from the laser
module to be counted. The photodiode has an amplifier, where the output is
“PULSES”
11 a series of pulses. The number of pulses sent from the laser corresponds to
display
the number of pulses selected on the display panel. In the case where more
pulses are delivered than what is selected, an error code is displayed, and the
system must be shut down. This display changes whenever the “SET
PULSES” button is pressed.
This display shows the measured energy level of the YAG laser in mJ. This
display also indicates the approximation of the selected energy when the
energy adjuster is changed. A photodiode is used to measure the energy
delivered with each shot. A small amplifier unit mounted in a housing
assembly produces a signal to the microprocessor between 0 and +5 VDC.
The control system must accept this input and scale it accordingly to display
“ENERGY”
12 the information as the energy delivered from the laser in mJ. This display is
display
required to be calibrated to be within ±10% of an external energy meter
reading. 2 potentiometers on the micro PCB allow for minor adjustments of
the photodiode signal to match the external meter. When the energy adjuster
or the number of pulses is changed, the laser system performs an automatic
test fire to verify the new energy level. The energy is then displayed on the
display panel.
Each time the laser is fired using the joystick fire button in TREAT mode, the
system adds both the energy and the actual number of pulses to their
respective accumulated register. The total in this register is displayed at all
“TOTAL”
13 on the 2 displays. The total pulse and energy displays will only increment
displays
when the laser is fired in TREAT mode and therefore, only indicate the actual
energy and pulses delivered from the system to the patient. By default, the
displays are always reset to zero upon system start-up.
This button can be used to reset both the TOTAL displays to zero to clear the
14 “RESET” button registers. This reset would be done between patients and after doing
performance and operating checks before using the laser on patients.
When this button is pressed and the laser system is in TREAT mode, a
pulse or burst of pulses will be delivered from the laser unit. If the fire
button is pressed for more than 800 ms (0.8 seconds), the microprocessor
will detect and put the laser system back into STANDBY mode. If the fire
button is pressed in STANDBY mode, it is not possible for the system to
go into TREAT mode.
Joystick fire Alternatively, a footswitch (normally open contact), can be connected to the
15
button rear panel of the control box to enable an optional footswitch operation. To
do so, the footswitch option would have to be selected in Special Mode. When
the footswitch is selected, the joystick is disabled. The system must be in
TREAT mode for the footswitch to fire the laser. Contact closure of the
footswitch will cause 1 laser pulse to occur in single pulse mode. If the
footswitch is operated for more than 2 seconds, then the system will
automatically go into STANDBY mode.
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 29 of 85
“ILLUMINATION
This provides control over the brightness of the illumination lamp in the slit
16 INTENSITY”
lamp.
knob
This button can be used by the user to momentarily provide maximum
17 “BOOST” button illumination to the patient’s eye. This button is not intended to be used for
long periods of time.
“AIMING Located on the right-hand side of the laser arm. This knob provides
18 INTENSITY” continuous adjustment over the aiming beam intensity. At minimum
intensity, there is still some illumination of the aiming beams.
knob
The 2 control knobs, that work simultaneously, on either side of the laser arm
are used by the user to adjust the YAG energy up or down. This YAG energy
adjuster brings down the delivered YAG energy as YAG laser always fires at
its maximum energy level. The wheel rotates through 3 complete turns. A
potentiometer connected to the energy control generates a 0 to +5 V signal,
YAG energy
19 depending on the position of the controls, which the control system reads and
adjuster
scales to display a Preset energy indication each time the controls are moved.
When the adjustment has been made, then the laser performs a test shot to
measure the actual YAG energy, which is then displayed as well. The
externally measured output YAG energy must be within ±20% of the YAG
preset energy for all settings at or above 1.0 mJ and ±30% below 1.0 mJ.
The 2 control knobs, that work simultaneously, on either side of the laser arm
are used by the user to adjust the SLT energy up or down. When the SLT
energy is adjusted, the microprocessor displays an approximation of the
SLT energy selected SLT energy on the “mJ” display. When an adjustment is made, the
20
adjuster laser performs a test shot to measure the actual SLT energy, which is then
displayed as well. The externally measured output SLT energy must be within
±20% of the SLT preset energy for all settings at or above 1.0 mJ and ±30%
below 1.0 mJ.
Located on the left-hand side of the laser arm. Allows the YAG treatment
laser beam focus point to be adjusted posterior (+) or anterior (-) to the aiming
beam focus. This control needs to be set by the user appropriate to the
procedure that is to be carried out. In general, these offset settings are used:
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 30 of 85
YAG mode
23 When this indicator is illuminated, the laser system is in YAG mode.
indicator
SLT mode
24 When this indicator is illuminated, the laser system is in SLT mode.
indicator
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 31 of 85
No. Item Description
The joystick provides control over the horizontal and vertical
1 Joystick arm movements of the slit lamp. Rotating it adjusts the vertical
height.
Both eyepieces have ±8 diopter adjustments to the viewing
2 Eyepiece diopters
focus. Always adjust focus from positive to negative direction.
The viewing field can have different magnifications (5X, 8X,
3 Magnification adjuster
14X, 25X, 38X) set by rotating this adjuster.
When this collar is rotated, the illumination slit rotates from 0°
4 Slit rotation collar
to 180°. At the center of the collar (0°), the slit is vertical.
Located on either side of the illumination tower. This knob
5 Slit width control knob
changes the width of the illumination slit.
6 Illumination aperture dial Controls the size of the illumination spot and the slit height.
Controls the illumination filter: cobalt blue, red, green (red-
7 Illumination filter dial
free), heat-absorbing.
Indicates the ideal height for positioning the patient’s eye in
8 Canthus mark order to be able to use the full vertical adjustment range of the
slit lamp.
Used by the physician as a reference point for the patient to look
9 Fixation lamp
at while being examined by the physician.
Can raise or lower the patient’s head in order to align their eye
10 Chinrest height adjuster
to the canthus mark on the chinrest post.
Locking screw for illumination
11 Locks the illumination tower in place.
tower
Locking screw for laser head
12 Locks the laser head arm in place.
arm
Locks the horizontal movement of the base. This should always
13 Locking screw for base be locked when the laser system is not in use or during transport
to ensure that the unit does not slide around uncontrollably.
The target rod is inserted into the slit lamp in order to set the
eyepiece oculars and to inspect or check the slit illumination.
14 Target rod The target rod cannot be used to check the laser operation by
firing onto the rod. The target rod must be removed from the
slit lamp before proceeding to fire the laser system in any way.
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 32 of 85
Section 5 Installation
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5.3 Unpacking and Receiving Inspection
The laser system is usually packed in two separate cardboard boxes as well as a portable carrying case, as
shown in Figures 6 and 7 below:
Upon receiving the system, please inspect the packing carton for signs of mishandling, which must be
reported to the freight handler before the instrument is unpacked. If the damage that occurred during
transport is not reported, the Manufacturer reserves the right to decline any warranty claims. The freight
company shall take full responsibility for any damage occurred during transport.
If the external cardboard packaging looks acceptable, proceed to check the internal packaging (Figure 6)
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 34 of 85
The top layer contains the slit lamp and laser arm.
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 35 of 85
The component of the package 1
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 36 of 85
The bottom layer contains the control box and binoculars assembly.
The packing list is used to verify the items delivered. Please notify the Manufacturer is any discrepancy is
found.
The ophthalmic table and portable carrying case (Figure 7) are optional and may be purchased from the
Manufacturer, if needed. The dimensions (W x L x H) for the carrying case are 450 x 580 x 770 mm.
Item Tools
Phillips screwdriver
Installation or Uninstallation
Laser energy meter to measure 0.2 to 45 mJ
Model eye
Laser target tool
Optical Alignment Photographic thermal paper (Zap-It or equivalent)
A set of metric Allen keys
Phillips screwdriver
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 37 of 85
5.5 Installation Process
The SeLecTor Deux laser system consists of a slit lamp, control box, and accessories that need to be
assembled by a trained and authorized Service Technician or installer.
Place the control box on the tabletop.
Combine the slitlamp and Laser with cross slide shaft and gears
(1) Separate the gear from the shaft by the allen key.
(2) Insert the shaft into the hole of the slitlamp and laser, and screwing the gear to the cross slide
shaft.
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 38 of 85
Install the slitlamp and Laser to the control box
(1) Release the part of the control box in order to sort out the cable of the instrument.
Figure 15 Install the slitlamp and Laser to the control box (1)
(2) The instrument is put on the control box, and the gear of the instrument have to match the
plastic rack on the control box.
Notice. Check the number of teeth on both sides has to match.
Figure 16 Install the slitlamp and Laser to the control box (2)
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 39 of 85
(3) The mark of cables has to match the edge of the control box.
Figure 17 Install the slitlamp and Laser to the control box (3)
(4) Insert the parts of the control box on both sides and install the part to the control box.
Figure 18 Install the slitlamp and Laser to the control box (4)
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 40 of 85
The approach of the cable connection
(1) The cable of the instrument must be connected to the plug seat at the back of control box.
(2) The power cord must be connected to the plug seat at the back of control box with passing
through the hole on the side of control box.
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 41 of 85
Install the cover for guide rail
(1) The cover for guide must be installed on the both sides of plastic rail.
(2) The chinrest wire must be connected to the plug seat at the back of control box.
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 42 of 85
(3) Mount the chinrest in position temporarily by the three screws.
(4) Insert the tailgate and tighten all four screws in order to make sure the electric wire don't
expose.
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 43 of 85
The top view of the SeLecTor Deux assembly.
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 44 of 85
The correct positioning of the 2 slit lamp cables.
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5.6 System Verification
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 46 of 85
5.6.2 Optical Alignment
For safety purposes, it is very important that the YAG and SLT treatment and aiming laser beams are
aligned to each other and that the YAG laser offset functions correctly. The treatment laser beam is invisible
to the human eye; therefore, it can only be correctly positioned on the patient eye using the 2 red aiming
beams.
This procedure should be carried out regularly by the user and must be performed when the laser system is
transported or moved to a new treatment room. It is likely for misalignment to occur if the unit is mishandled
during transport. It is recommended that this procedure be carried out at least once a month.
Tools needed:
A small piece of photographic or thermally sensitive paper (a sample piece is supplied with each
laser system).
Target plate (with attached thermal paper).
Procedures:
1. Attach the thermal paper to the target plate. Equip the target plate to the chinrest.
2. Turn ON the slit lamp illumination. Select the 6- or 10-mm diameter full aperture (full circle, no
slit). Make sure the diopter settings on the oculars are set correctly.
3. Position the slit lamp so that the illumination spot is focused on the paper on the target plate.
4. Turn ON the laser system. Set the YAG offset to zero (0). In STANDBY mode, finely adjust the slit
lamp position so that the 2 red aiming beams merge into a single spot (Figure 14). If the 2 red
aiming beams are not able to merge to a single spot despite positioning the slit lamp closer to the
target plate, then the optical alignment is inaccurate. Contact the Manufacturer or local authorized
Service Engineer for service.
5. The merged aiming beams should fall in the central region of the illumination spot (Figure 14).
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 47 of 85
6. Set the YAG laser energy to a minimum setting or at least less than 1 mJ. Put the laser in TREAT
mode. Verify that the 2 aiming beams are merged into one. Fire a YAG laser shot onto the thermal
paper on the target plate.
7. Look through the binoculars and verify that the YAG burn mark is centered to the merged aiming
beams, within the central region of the illumination spot (Figure 15). Repeat the test on a new area
of the target to confirm the findings.
8. Repeat the steps above at +150 and -150 µm offset settings. At zero (0) offset, the YAG burn mark
should be the smallest spot compared to the +150 and -150 µm offset settings. If the YAG burn
marks are not clear enough, then increase the energy by 1 mJ and try again. All the YAG burn
marks should be centered to the merged aiming beams. If the YAG offset focus is incorrect, then
contact the Manufacturer or local authorized Service Engineer because an optical alignment needs
to be redone.
Figure 31 YAG burn mark aligned to the merged aiming beams and illumination spot.
9. Take a YAG burn at zero (0) offset and minimum YAG energy. Look through the binoculars and
note the position of the YAG burn mark. Press the “MODE” button to switch from YAG to SLT
mode. Verify that the SLT aiming beam is aligned to the YAG burn mark.
10. Set the SLT laser energy to a minimum setting. Put the laser in TREAT mode. Fire an SLT laser
shot onto the thermal paper on the target plate.
11. Look through the binoculars and verify that the SLT burn mark is centered to the SLT aiming beam,
within the central region of the illumination spot. Repeat the test on a new area of the target to
confirm the findings.
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 48 of 85
LIGHTMED SeLecTor Deux Service Report
1. CUSTOMER INFORMATION
Service Request Date Customer Name
Customer Address City State Country
Contact Person Phone Email
2. SERVICE DETAILS
Service Engineer Name Service Company Name
Service Date Service Location □ On-site □ LIGHTMED
4. SYSTEM DETAILS
□ YAG □SLT
Product Name Laser S/N Product Type
□ YAG & SLT
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 49 of 85
5. TEST EQUIPMENT
Equipment Name Equipment Model Name Equipment Serial Number Calibration Due Date
Energy Meter
Energy Detector Head
6. SERVICE SUMMARY
Reported Issue
Conditions Observed
Actions Taken
System Status □ Working properly □ Faulty, not in use □ Part shortage □ Other: ___________________
Part Replaced Name Part Number Old Part S/N New Part S/N
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 50 of 85
5. Slit is fully adjustable, from open to closed positions. □ □
13. Slit lamp movements with joystick are smooth (no tension or friction). □ □
14. Illumination tower and laser arm can be swung from side to side. □ □
Chinrest Check
1. Chinrest is securely tightened to the control box, not loose. □ □
5. Energy is displayed. □ □
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 51 of 85
LIGHTMED SeLecTor Deux Service Report
2. Center of Rotation □ □ □ □
3. Background Focus □ □ □ □
6. YAG Offset □ □ □ □
9. Clean Lens □ □ □ □
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 52 of 85
LIGHTMED SeLecTor Deux Service Report
10. YAG 1064nm ENERGY CALIBRATION (mJ) ±20% TOLERANCE (SERVICE MODE)
PRESET ENERGY AVG. INT. ENERGY AVG. EXT. ENERGY PASS FAIL ADJUSTED N/A
Single Pulse
0.2 □ □ □ □
1.0 □ □ □ □
2.0 □ □ □ □
5.0 □ □ □ □
8.0 □ □ □ □
Max. = ______ □ □ □ □
Double Pulse
4.0 □ □ □ □
Max. = ______ □ □ □ □
Triple Pulse
6.0 □ □ □ □
Max. = ______ □ □ □ □
11. SLT 532nm ENERGY CALIBRATION (mJ) ±20% TOLERANCE (SERVICE MODE)
PRESET ENERGY AVG. INT. ENERGY AVG. EXT. ENERGY PASS FAIL ADJUSTED N/A
Single Pulse
0.2 □ □ □ □
1.2 □ □ □ □
Max. = ______ □ □ □ □
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 53 of 85
LIGHTMED SeLecTor Deux Service Report
2. Installation Checklist □ □
3. Optical Alignment □ □
7. Voltage Calibration □ □
Notes
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 54 of 85
Section 6 Clinical Use
The SeLecTor Deux laser system can be used as a slit lamp microscope or an ophthalmic laser. This laser
system is used for performing the following clinical procedures:
This system delivers pulses of 1064 nm wavelength laser light to patients under the control of the physician.
The effect of the laser on tissue depends on the energy level, offset setting, type of tissue, and the tissue
pigmentation. The SeLecTor Deux delivers opto-acoustic effect to the tissue rather than bulk tissue heating.
When the laser is fired in the ocular media, plasma bubble is formed, and this explosion creates an acoustic
wave around the central focus spot that directs the energy back towards the tissue. The plasma also provides
a shielding effect that scatters the incident light so that the structure beyond the affected area is protected
from damage. Due to the incident cone of angle of the laser beam, the beam diverges after the focus point,
thus, lowering the energy density on the retina.
For this laser system, there are several key safety issues to consider:
All laser treatment indications and contraindications are well documented and readily available for the
doctor’s reference.
There is a long history for the various treatments when using this laser, so all possible side effects and
adverse reactions are well understood.
The doctor should always ensure that they are adequately trained or knowledgeable to perform the laser
procedures when using this laser system. It is strongly recommended that all physicians are diligent
with training in order to gain experience on the procedures before treating an actual patient. A model
eye can be purchased from the Manufacturer as an accessory to assist in the training of this laser system.
WARNING! The Manufacturer and Distributor assume no responsibility for the actions of the user
when using this equipment. Users must ensure that the correct methods, techniques, and settings are
used while performing clinical procedures to the patient. The laser beam can cause serious and
permanent injury if not used correctly. All safety precautions must always be observed when using
this laser system.
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 55 of 85
6.1 Posterior Capsulotomy (YAG)
There are several techniques involved in performing the Posterior Capsulotomy procedure. The indications,
contraindications, warnings, and recommendations for the use of the YAG laser on aphakic and pseudo-
phakic patients are explained in more detail below:
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 56 of 85
congestive heart disease, a drop of Timolol 0.5% at the end of the treatment should suffice.
Alternative medications are pilocarpine or a carbonic anhydrase inhibitor. The possibility
of a delayed pressure rise after use of these medications must be considered and an
examination on the next day is indicated.
o Glaucoma patients require an increase in dosage of medication. Glaucoma patients on
intensive therapy should be observed closely for 4 to 6 hours following treatment.
o For management of sight threatening pressure elevation, the following should be
considered:
Progressive intravenous administration of mannitol.
Anterior chamber paracenteses.
Anterior chamber washout.
Emergency washout.
o High-risk patients should be treated with multiple sessions, with a few shots administered
at low energies per session.
Rupture of the anterior hyaloid face can occur as a result of performing a posterior capsulotomy.
When this occurs, the patient is at risk of having forward movement of the vitreous, resulting in
corneal edema. If the opening of the posterior capsule is small, then a posterior chamber IOL offers
some protection against this forward movement.
IOLs are all susceptible to damage such as pitting or cracks from the YAG laser. Posterior chamber
IOLs are more prone to damage. The risk of damage is increased if the posterior capsule lies close
to the IOL and if higher energy levels are used or total energy delivered increases. There are several
actions that can reduce the likelihood of damaging IOLs:
o Use a recommended contact lens when performing the procedure.
o Maintain precise focusing and alignment of the aiming beams.
o Set the correct posterior YAG laser offset focus for the energy used.
o Always use the lowest possible energy to open or cut the membrane.
o Do not rapidly fire the laser, use burst mode, or make successive shots through the same
positions on the IOL.
o Optimize the view of the capsule or membrane surface by setting up the slit lamp controls
correctly.
o Avoid YAG treatment on patients with glass IOLs unless necessary. In this case, use
extreme caution and start at low energies.
o Keep the patient still to avoid firing the laser in the wrong place.
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 57 of 85
Recommendations for posterior capsulotomy (YAG) use:
Correct and accurate focusing is of utmost importance for proper use of the YAG laser system. The
following procedures should be followed to ensure optimal surgical applications of this device.
o The invisible beam of the Nd:YAG laser is parfocal in air with the visible dual aiming
beams. The intersections of twin aiming beams, where the two red spots become one,
locates centrally the focal point of the YAG laser energy. The YAG beam has a small
posterior focus to the aiming beams. Ensure that the correct focus is set and do not use the
anterior (-) offset focus settings at any time when performing posterior capsulotomy or
membranectomy procedures.
o Multiple reflections of light from the aiming beams and slit lamp illumination present
difficulties in focusing. The use of contact lens, slight off-axial direction of the slit lamp,
and selective positioning of the patient may decrease this problem.
o In the aphakic patient, the focal point of the YAG beam is generally placed directly on the
posterior capsule.
o In the pseudo-phakic patient, particularly with a posterior chamber IOL, the focal point of
the YAG is generally placed slightly more posterior to the posterior capsule, thus giving
two adjacent red spots on the capsule. Care must be taken to ensure that the focal point is
posterior to the capsule, because an anterior focus will also produce two red aiming spots.
The predominant effect of the YAG energy shock wave is anterior to the focal point,
therefore targeting directly on the pacified capsule, increasing the risk of damage to an IOL
immediately anterior to the capsule. If the membrane does not open, the focal point should
be brought forward slightly. Successive shots, however, should be positioned to avoid
repeated firings through the same spot on the IOL. Each exposure reduces the PMMA
damage threshold for subsequent exposures.
o Better depth perception for use in treatments may result when the slit lamp illumination is
positioned slightly off axis to the aiming beams.
o Concentrate, above all, on careful and precise aiming technique. Do not deliver YAG
pulses in rapid succession. Instead, attempt to place each shot with deliberation.
Plan each membrane discission before starting. Note the relative position of the center of the pupil
prior to dilation in order to obtain a central opening. Also, look for stretch lines in the membrane
that can aid discission by tearing.
Plan the size opening that is needed based on the prediction and post-operative fundus examination.
Always make the smallest opening allowable. Enough acuity can often be achieved with only a 2
mm opening.
Start all therapies at the minimum energy dosage level possible and verify effect before increasing
energy levels.
If disruption effects are insufficient, attempt to aim more precisely before increasing energy.
Use the lowest number of pulses required to achieve the desired result.
Be prepared to schedule multiple treatment sessions if cloudiness or turbidity interfere with aiming
or disruption treatment.
In the case of membranes very close to the posterior surface of a posterior chamber implant, start
with a pulse slightly more posterior to the membrane and move gradually anterior until just enough
disruption is achieved.
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 58 of 85
Exercise special caution when membranes are heavily laden with cortex. Avoid admixture of cortex.
Perform the initial membranectomy with aphakic patients or on patients where the implant is clearly
separated from the membrane.
Use a proper YAG contact lens, especially when membranes are close to or touching an implant.
Be sure to hold the lens perpendicular to the laser beam axis.
Avoid cutting too close to the iris in order to minimize the likelihood of hemorrhage. The physician
will decide on the exact dosage levels and therapeutic strategies. Dosage levels will vary from case
to case, depending on many factors for each case. The user’s own judgment, based on training and
personal experience, will serve as the best guideline for application.
These methods have been accepted in the opening of pupillary membranes:
o Central or Cruciate Approach:
The usual strategy is to create a cruciate opening beginning near the 12 o’clock
position, then moving downward to the 6 o’clock position. Shots are then placed
laterally towards the 3 and 9 o’clock locations. Care should be taken to ensure that
the shots are not placed too close to the iris, otherwise, bleeding may occur.
Bleeding will generally stop spontaneously but may be aggravated by further
treatment.
If the IOL is near the rear surface of the capsule, then the focus point of the
treatment laser should be placed slightly posterior to the capsule. This will
minimize pitting and damage to the IOL. The focus position is achieved by
focusing on the capsule by merging the two red aiming beams. This can be
achieved via two methods:
Set the YAG offset to zero, then move the joystick forward until the two
spots separate by approximately one-spot diameter.
Set the YAG offset to +150 µm for the starting energy so that when the
aiming beams are merged, the YAG treatment beam is very unlikely going
to damage the IOL.
For either methods, start firing with the energy set to below 1.0 mJ, depending on
capsule density. If no results are obtained energies around 2.0 mJ, then the approach
should be reevaluated before proceeding. Potential cause for the need to increase the
energy for disruption may be a media problem, incorrect focus, highly opaque
membrane or instrument difficulty.
o Posterior Defocus Approach:
This technique is useful when the posterior membrane is located very close to the
IOL and direct aiming on the membrane may damage the IOL. The membrane can
be ruptured by an acoustic wave that can be produced by firing from 1 to 2 mJ in
the vitreous.
Set energy from 1 to 2 mJ and aim the two aiming beams for coincidence in the
center of the pupil. Deliberately defocus the instrument posteriorly by advancing
the joystick until the aiming beam separation is two diameters or more, and then
fire the laser. A slightly higher energy can be set if required. Deliberately defocus
the YAG laser treatment beam by the same methods as described in Central or
Cruciate Approach, and then fire the laser. Take caution when increasing the YAG
offset as the energy level increases, otherwise, damage may occur to the IOL.
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 59 of 85
o Modified Cruciate Approach:
This approach is useful if the IOL is prone to pitting. If there is an indication of
IOL marking after the strategy of beginning the capsulotomy in the 12 o’clock
position, then the Cruciate Approach should be modified.
Instead of the 12 to 6 o’clock progression across the visual axis, an opening in the
shape of a Christmas tree should be performed. Shots placed at the 12 o’clock
position, 4:30 and 7:30 locations, without any shots placed in the central optical
axis, will produce the desired opening. The same low energy settings and focus
techniques apply as with the Cruciate Approach.
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 60 of 85
If there is a high risk of retinal detachment, then the absolute minimum number of shots should be
used.
If there is a risk of uncontrolled bleeding, inability to create a hole in the iris or hole closure as a
result of chronic uveitis, hemophilia, nystagmus, neovascular glaucoma, engorged iris blood
vessels, or uncooperative patients.
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 61 of 85
Retinal damage is theoretically possible although the risks are considerably lower than when using
the YAG laser to perform posterior capsulotomy or pupillary membranectomy. The same
precautions that reduce the risk of lens damage should be observed for this risk.
o Transient self-limited tricking hemorrhage can occur in around 25% of eyes undergoing
YAG laser iridotomy. The YAG laser does not cauterize blood vessels so eyes with
engorged iris blood vessels, hemophilia patients or those receiving anticoagulant
treatments offer an increased risk of bleeding and hyphemia. Normal bleeding will stop
immediately and can be controlled with light pressure against the contact lens.
o If bleeding does occur, then more YAG treatment may aggravate it. The use of a few drops
of apraclonidine pre- and post-laser can minimize bleeding and reduce the rate of acute
IOP. Photocoagulation may be required if other measured do not stop the bleeding.
Localized corneal edema or scarring is possible above the iridotomy site. Opacities generally clear
within a few days and the changes described do not interfere with visual function. Accurate
positioning and focus of the laser beam and lower energy settings are important.
For patients with chronic uveitis, there is a possibility of closure of the iridotomy weeks or months
after the treatment. The closure rate of iridotomy is much lower when using the YAG laser than
when treating with a photocoagulator.
Long-term control of glaucoma is not always seen after a successful iridotomy. This is the case for
both YAG and photocoagulator iridotomy. Patients should be further monitored for persistent
glaucoma following iridotomy treatment.
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 62 of 85
An anterior segment treatment contact lens is recommended as this lens increases the convergence
angle and energy density to the treatment site. It also provides better control over the eye position,
keeps the eyelid open, and increases the magnification. Contact the Manufacturer for more
information on contact lens supply.
The use of pilocarpine hydrochloride (1 to 4%) should be applied several hours prior to the
treatment to produce meiosis and stretch on the iris that aids the iridotomy treatment.
The treatment site selected should be superior between 9 and 3 o’clock positions, nasally to avoid
inadvertent macular damage but not at the 12 o’clock position.
The treatment site should also be at the mid to far iris periphery, central to the arcus senilis, and in
an area of an iris crypt if one exists and is usable as this area is thinner.
The treatment site should be away from IOL, if possible.
Start all therapies at the minimum energy dose level possible to achieve the opening. But it should
be noted that the likelihood of completing an iridotomy with one pulse is higher with the use of
around 10 mJ—however, there is an increased risk of bleeding and crystalline lens damage. The
benefits of easier and quicker iridotomy must be weighed against risks of bleeding when using
higher energy settings.
Typical YAG laser energy settings of 4 to 8 mJ are required. A full thickness opening in one shot
is desirable although up to 4 shots may be required. If required, the energy may be increased in 1
or 2 mJ intervals or increase the burst mode to 2 or 3 pulses per shot. It is not recommended to set
energy levels higher than 10 mJ. Start at low energy settings first and increase the energy based on
the observed effects, not just previous operations.
Typically, the YAG laser offset should be set to an anterior (-) setting to avoid possibly damaging
the structures behind the iris. If the offset is set too high, then the energy may need to be set to
unacceptably high levels to get the desired effect. If the effect is poor, reducing the offset closer to
zero (0) may help to achieve the desired effect.
In dark brown irises without crypts, it may be an advantage to set a higher starting energy of close
to 10 mJ at single pulse.
Once an opening is produced or if it is unclear whether an opening is patent, it is not advisable to
continue treatment at that site as it exposes the lens capsule to the possibility of damage from the
laser pulse. An extended burst mode of more than 3 pulses also has the potential to expose the
underlying lens capsule to damage if the iris opening is produced before the bursts are completed.
The inability to perforate the iris using the above treatment parameters may indicate incorrect focus,
a media problem, an instrument malfunction, or a very strong iris.
After each laser energy pulse is delivered, the treatment site should be inspected and if the anterior
lens capsule is clearly visible, then no further laser treatment should be applied to that site.
Following laser treatment, the patient’s eye should be observed with the contact lens for 2 to 3
minutes to ensure that no iris bleeding occurs. Pressure can be applied to the contact lens to control
bleeding.
The anterior chamber can be treated with topical corticosteroids after the removal of the contact
lens to decrease reaction.
In the aphakic and pseudo-phakic patients, at least 3 iridotomy treatments may be required to ensure
full relief of aqueous entrapment that may be localized into sectors.
Post-operative care should include monitoring the IOP, inflammation, bleeding, and lens clarity.
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 63 of 85
6.4 Selective Laser Trabeculoplasty (SLT)
Lowering IOL can prevent the development or progression of glaucoma-related blindness. SLT offers a
safe and effective therapy for lowering IOP. This treatment is used as a primary treatment option for early
stages of open-angle glaucoma (OAG) and can be used in combination with drug therapy or as an alternative
therapy when drugs fail. It is also a flexible treatment option given that it can be repeated if necessary,
depending on the individual patient’s response.
This treatment uses a frequency-doubled YAG laser light with a wavelength of 532 nm, a pulse duration of
3 ns, and a spot size of 400 µm. SLT is based on the application of the selective photothermolysis principle
where short pulses of light are selectively absorbed by pigmented structures, principally melanin granules
that present either within cells or dispersed in the extracellular tissue space. The pulses of light are much
shorter than the thermal relaxation time effectively preventing damage because of collateral thermal effects.
SLT is a non-thermal treatment which uses these short pulses of 532 nm light of relatively low energy to
target and irradiate only the melanin-rich cells in the trabecular meshwork. The laser pulses only affect
these melanin-containing cells, and the surrounding structure of the trabecular meshwork is unaffected.
During the procedure, approximately 50 confluent spots are applied along the meshwork in order to treat a
180° angle. This gentle laser treatment induces an automatic response from the body in which macrophages
are released to clear the affected cells and rebuild the meshwork so that it functions again effectively, thus
reducing the IOP.
SLT effectively lowers elevated IOP without the side effects and compliance issues associated with drug
therapy. This treatment is particularly appropriate for individuals who cannot correctly administer, or are
intolerant to, glaucoma medications, and can also be used in conjunction with medication to enhance the
overall IOP-lowering effect.
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 64 of 85
Contraindications for SLT use:
Secondary glaucoma (inflammatory, neovascular).
Chronic angle closure eyes.
Traumatic angle recession.
Decreased IOP reduction in patients at maximal medical therapy (still a good choice before surgery,
but ideally use SLT prior to this point).
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 65 of 85
Section 7 Troubleshooting
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 66 of 85
Verify that the mains power is
connected to the laser unit, the key
switch is in the ON position, and
Illumination the red emergency stop button is
4 LED released.
module If the LED module needs to be
replaced, contact the Manufacturer
or local authorized Service
Engineer for assistance.
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 67 of 85
Error Code Description Corrective action
There is a detector and circuit that checks for the number of
laser pulses for every shot of the Laser Cavity. If the
Err 03: control system detects that the system has fired more
pulses than that selected on the front panel then this
Overpulses error
message will be displayed. This error condition does not
occur during the Voltage Calibration and Service Check
modes.
The Aiming Laser has a circuit that checks its output for
Err 04: operation. If the Control System detects that the Aiming
Laser output has failed then this error message is
Aiming error
displayed. This will normally indicate that the Aiming
Laser diode or circuit has failed.
The Control System performs a self-test or checksum test
Err 05: when the power is turned on. During the start up
program, the EEPROM and RAM addresses are
Checksum error
verified as not being corrupt. If any error is detected
during this program then this error message is displayed. Reboot the system.
If the error code persists,
During the Voltage Calibration and Service Check modes if contact the Manufacturer
Err 06: the threshold voltage for single pulse operation exceeds or local authorized Service
600 Volts then this error message is displayed. This error is Engineer.
Threshold error 1
most likely the result of a faulty Arclamp Trigger circuit or
a faulty Laser Arclamp.
Err 07: During the Voltage Calibration and Service Check modes if
the threshold voltage for quadruple pulse operation
Threshold error 2
exceeds 860 Volts then this error message is displayed.
During the Service Check mode if the single pulse
Err 08:
voltage has changed significantly from the previously set
Energy and stored voltage then this error message will be
deterioration error displayed. If this error occurs then it means the
operating mode of the Laser cavity has changed a lot.
Every time the Laser is fired the Control System checks for
the number of Laser pulses and the energy delivered. If any
Err 09:
shots are fired and the energy is less than 0.1 mJ but a
Low energy error pulse is detected then this error message is displayed.
This error indicates either a failure in the Energy meter
detector or circuit.
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 68 of 85
Error Code Description Corrective action
Err 10: This error indicates CPU board continuously receive the
Joystick error single of firing laser.
Whenever the laser power is turned on, the system will run
automatically checking to make sure all the laser function
Err 11: works well. During the self-test period, if the Control
Laser PSU error system detects the high voltage supplied form the control
box to the trigger module is insufficient or too low, this
error will show up on the main display.
The Control System performs a self-test whenever the
power is turned on. During the start up program the Reboot the system.
Err 12: EEPROM and RAM addresses are verified as not being If the error code persists,
corrupt. Once the system passes this checking, it will contact the Manufacturer
EEPROM error
then enter the self-test procedure. If any error is or local authorized Service
detected during this program then this error message is Engineer.
displayed.
In SeLecTor, these two modes are switched by a motor
Err 13: rotation, controlling the PBS at 0∘ or 90∘ positions. In every
operation stages including the self test, mode switch, and
YAG/SLT mode
laser shot, the Control system will always keep monitoring
switch error(only
the PBS position. Once the Control system detects the PCB
in SLT)
at wrong position no matter in what stages the system is, this
error will immediately show up on the main display.
Err 14:
TEC heating error(only YAG/SLT before 2015)
TEC heating error
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 69 of 85
Section 8 Electromagnetic Compatibility (EMC) Test
RF emissions
Class B
CISPR 11
The Ophthalmic YAG Laser, SeLecTor Deux is suitable
Harmonic emissions for use in all establishments, including domestic
Class A
IEC 61000-3-2 establishments and those directly connected to the public
low-voltage power supply network that supplies buildings
Voltage fluctuations/ flicker used for domestic purposes.
emissions Complies
IEC 61000-3-3
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 70 of 85
Recommended Separation Distances Between Portable and Mobile RF Communications
Equipment and The Ophthalmic YAG Laser, Selector Deux
The ophthalmic laser, LIGHTLas SeLecTor Deux, is intended for use in an electromagnetic environment
in which radiated RF disturbances are controlled. The customer or the user of this system can help
prevent electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the ophthalmic laser, LIGHTLas SeLecTor Deux, as
recommended below, according to the maximum output power of the communications equipment.
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 71 of 85
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The ophthalmic laser, LIGHTLas SeLecTor Deux, is intended for use in the electromagnetic environment
specified below. The customer or the user of this system should assure that it is used in such an
environment.
IEC 60601 Electromagnetic Environment –
Immunity Test Compliance Level
Test Level Guidance
Surge ±1 kV line(s) to line(s) ±1 kV line(s) to line(s) Mains power quality should be that of a
typical commercial or hospital
IEC 61000-4-5 ±2 kV line(s) to earth ±2 kV line(s) to earth environment.
Power frequency
Power frequency magnetic fields should
(50/60 Hz)
be at levels characteristic of a typical
3 A/m 3 A/m
magnetic field location in a typical commercial or
hospital environment.
IEC 61000-4-8
NOTE: UT is the AC mains voltage prior to application of the test level.
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 72 of 85
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The ophthalmic laser, LIGHTLas SeLecTor Deux, is intended for use in the electromagnetic
environment specified below. The customer or the user of this system should assure that it is used in
such an environment.
IEC 60601 Test Compliance
Immunity Test Electromagnetic Environment – Guidance
Level Level
Portable and mobile RF communications
equipment should be used no closer to any part of
the ophthalmic laser, LIGHTLas SeLecTor Deux,
including cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
Conducted RF 3 Vrms d = 1,2
3 Vrms
IEC 61000-4-6 150 kHz to 80 MHz d = 1,2 80 MHz to 800 MHz
d = 1,2 800 MHz to 2,5 GHz
where P is the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and d is the
Radiated RF 3 V/m recommended separation distance in meters (m).
3 V/m
IEC 61000-4-3 80 MHz to 2,5 GHz Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey
should be less than the compliance level in each
frequency range.
Interference may occur in the vicinity of
equipment marked with the following symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which
the ophthalmic laser, LIGHTLas SeLecTor Deux, is used exceeds the applicable RF compliance level
above, the ophthalmic laser, LIGHTLas SeLecTor Deux, should be observed to verify normal operation.
If abnormal performance is observed, additional measures may be necessary, such as reorienting or
relocating the ophthalmic laser, LIGHTLas SeLecTor Deux. Over the frequency range 150 kHz to 80
MHz, field strengths should be less than 3 V/m.
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 73 of 85
Section 9 User Maintenance
The SeLecTor Deux laser system is designed to require minimal maintenance. There are several simple
routine procedures that must be carried out by the user, but aside from that, there are no user maintenance
requirements.
The Manufacturer, however, does recommend that the SeLecTor Deux laser systems be serviced by an
authorized Service Engineer every 6 months. However, it is a requirement that this system be serviced
annually, every 12 months. During this preventive maintenance (PM) service visit, the laser system will be
calibrated and aligned while verifying general operating functions.
It is a requirement that on an annual basis (every 12 months), the SeLecTor Deux laser system be
calibrated and have its earth leakage current and earth resistance measured according to EN60601-
1. These procedures can only be performed by an authorized Service Engineer approved by the
Manufacturer.
If at any time the user has any concerns about any aspect of the laser system, they are urged to contact the
authorized representative or the Manufacturer in order to decide on a suitable course of action.
Refer to Section 10 Warranty Details and Conditions of this Manual for specific national requirements
for EU countries.
The following procedures are recommended by the Manufacturer for the user to follow:
1. Clean the external surfaces of the laser using a damp, but not dripping, cloth. Use a mild cleaning agent
and do not use any solvents. Do not spray or pour any cleaning agents directly onto the laser system.
Avoid touching the optics, as there is a specific procedure to clean them (Step 2 below). Use a dry cloth
afterwards or allow it to air dry. This procedure should be carried out often, at least once every 3 months.
When the laser system is not in use, keep it covered using the dust cover provided by the Manufacturer.
2. Clean the optics (objective lens, illumination tower prism, the eyepieces, and other slit lamp accessory)
by gently wiping across the optics using the moistened end of a cotton tip (Q-tip) or a folded lens tissue
(Kodak or similar) with 100% methanol or ethanol. Use only one Q-tip or lens tissue per wipe, then
discard it. Repeat with a new Q-tip or lens tissue until the surfaces of the optics are clean. Never wipe
an optic with a dry Q-tip or lens tissue as this will scratch the optics.
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 74 of 85
Section 10 Warranty Details and Conditions
The Manufacturer provides a limited warranty on the SeLecTor Deux laser system for a fixed period from
the date of initial installation. The warranty period is for a minimum of 12 months. However, some
Distributors may offer extended warranty periods. Please contact your local Distributor for this information
for more details. The Manufacturer warrants that the SeLecTor Deux laser system is free of defects in
materials and workmanship, provided an authorized Service Engineer carries out the installation. The
warranty applies only to the original purchaser of the equipment in the country of original shipment.
This warranty will be voided, and the Manufacturer and Distributor will not be responsible if this equipment:
Has been altered, modified, serviced, or repaired by anyone other than the authorized Service
Engineers certified by the Manufacturer.
Is not operated according to the instructions described in this Manual.
Is not serviced according to the instructions and procedures mentioned in this Manual.
Is subjected to misuse, negligence, or accidents.
Is not installed according to the Manufacturer’s instructions.
Is connected to or used with accessories or spare parts, that are not, and have not, been tested and
approved by the Manufacturer.
The obligation of this warranty shall be limited to the repair or replacement, at the Manufacturer’s
recommendation and expense, of any materials or products that are shown to be defective from faulty
material and/or poor workmanship during the stated warranty period. The Manufacturer reserves the right
to examine and make the necessary repairs at its own premises, at an authorized repair center, or the site of
installation. The Customer will pay for all freight and handling charges.
The Manufacturer shall not be liable for any incidental or special damages or any other loss, damage, or
expense that arises directly or indirectly from a warranty claim, the use of the warranted product, the
inability to use the warranted product while being repaired or replaced, or otherwise.
Except as expressed above, the Manufacturer makes no other warranty of any kind, express, or implied,
including warranties of merchantability of fitness for any particular purpose or use.
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 75 of 85
Section 11 EMC Test Tables
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 76 of 85
Recommended separation distances between
portable and mobile RF communications equipment and the
Ophthalmic YAG Laser, SeLecTor Deux
The Ophthalmic YAG Laser, SeLecTor Deux is intended for use in an electromagnetic environment
in which radiated RF disturbances are controlled. The customer or the user of the Ophthalmic YAG
Laser, SeLecTor Deux can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and the
Ophthalmic YAG Laser, SeLecTor Deux as recommended below, according to the maximum
output power of the communications equipment.
Rated maximum Separation distance according to frequency of transmitter
output power of
m
transmitter
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz
W
d = 1,2 d = 1,2 d = 2,3
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 77 of 85
Guidance and manufacturer’s declaration – electromagnetic immunity
The Ophthalmic YAG Laser, SeLecTor Deux is intended for use in the electromagnetic environment
specified below. The customer or the user of the Ophthalmic YAG Laser, SeLecTor Deux should assure
that it is used in such an environment.
IEC 60601 Electromagnetic environment
Immunity test Compliance level
test level – guidance
<5 % UT (>95 % dip <5 % UT (>95 % dip Mains power quality should be
in UT) → for 0,5 cycle in UT) → for 0,5 cycle that of a typical commercial or
hospital environment. If the user
interruptions and of the Ophthalmic YAG Laser,
40 % UT (60 % dip in 40 % UT (60 % dip in SeLecTor Deux requires
voltage variations continued operation during
UT) → for 5 cycles UT) → for 5 cycles
on power supply power
input lines mains interruptions, it is
70 % UT (30 % dip in 70 % UT (30 % dip in recommended that the
UT) → for 25 cycles UT) → for 25 cycles Ophthalmic YAG Laser,
IEC 61000-4-11 SeLecTor Deux be powered from
an uninterruptible power supply
<5 % UT (>95 % dip <5 % UT (>95 % dip or a battery.
in UT) → for 5 sec in UT) → for 5 sec
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 78 of 85
Guidance and manufacturer’s declaration – electromagnetic immunity
The Ophthalmic YAG Laser, SeLecTor Deux is intended for use in the electromagnetic environment
specified below. The customer or the user of the Ophthalmic YAG Laser, SeLecTor Deux should assure
that it is used in such an environment.
IEC 60601 test Complian
Immunity test Electromagnetic environment – guidance
level ce level
Portable and mobile RF communications
equipment should be used no closer to any part of
the Ophthalmic YAG Laser, SeLecTor Deux
including cables, than the recommended separation
distance calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which
the Ophthalmic YAG Laser, SeLecTor Deux is used exceeds the applicable RF compliance level above,
the Ophthalmic YAG Laser, SeLecTor Deux should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as reorienting or relocating the
Ophthalmic YAG Laser, SeLecTor Deux.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 79 of 85
Appendix I Optional Accessories
The following accessories can be purchased from the Distributor to use with the SeLecTor Deux laser
system.
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 80 of 85
27 10X YAG BET module YL6500
28 SLT BET and mirror module YL6550
29 Aiming laser module YL4700
30 YAG mirror module YL4600
31 PBS module YL4200
32 SLT KTP module YL4800
Appendix II Glossary
The abbreviations used in this Manual are as follows:
Abbreviation Description
ABD Air breakdown
AC Alternating current
AEL Accessible Emission Limits
ALT Argon laser trabeculoplasty
ANSI American National Standards Institute
AP Anesthesia proofed
APG Anesthesia proofed gas
CFR Code of Federal Regulations
CW Continuous wave
DC Direct current
DSF Doctor safety filter
EC European Commission
EEC European Economic Community
EEPROM Electronically erasable programmable read-only memory
EMC Electromagnetic compatibility
EN European Standards
EU European Union
FDA Food and Drug Administration
FWHM Full width at half maximum
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 81 of 85
IEC International Electrotechnical Commission
IOL Intraocular lens
IOP Intraocular pressure
ISO International Organization for Standardization
JIS Japanese Industrial Standards
LED Light-emitting diode
MDD Medical Devices Directive
MPE Maximum permissible exposure
Nd Neodymium
NOHD Nominal ocular hazard distance
NSAID Non-steroidal anti-inflammatory drugs
OAG Open-angle glaucoma
OD Optical density
PCB Printed circuit board
PM Preventive maintenance
PMMA Poly (methyl methacrylate)
PSU Power supply unit
USA United States of America
YAG Yttrium Aluminum Garnet
Unit Description
g Gram
Hz Hertz
J Joule
kg Kilogram
m Meter
mJ Millijoule
mm Millimeter
ms Millisecond
Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 82 of 85
nm Nanometer
ns Nanosecond
s Second
µm Micrometer (Micron)
µs Microsecond
µW Microwatt
V Volts
VAC Volts for alternating current
VDC Volts for direct current
W Watts
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Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 85 of 85