Operator's Manual - YAG Laser SeLecTor Deux

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Operator's Manual

Ophthalmic YAG Laser


SeLecTor Deux.
Operator’s Manual

For The

Ophthalmic YAG Laser


SeLecTor Deux.

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!

Any modifications to the Laser will result in it needing a reclassification!

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.

Copyright © LIGHTMED Corporation

Manufactured by: LIGHTMED Corporation, No.1-1, Lane 1, Sec. 3, Pao An St., Shulin
District, New Taipei City 23861, Taiwan
____________________________________________________________________________

USA Address: 1130 Calle Cordillera, San Clemente, CA 92673


USA Telephone No.: +1 (949) 218-9555 Fax No.: +1 (949) 218-9556
Email: service@lightmedusa.com
____________________________________________________________________________

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.

Document Number: YL0416

Document Revision History:

Draft Jan. 2009 Draft prepared


01 Oct. 2009 First release
02 Jun. 2010 Change CE0197 to CE0434, all labels add the graphic symbol,
93/42/EEC as amended by 2007/47/EC, update standards, update
address of manufacture, update labeling to comply with IEC standard 60825-1
and the USA 21 CFR 1040.10, 1040.11
03 Oct. 2014 Change Section 2.2 Conformance to Standards, update the revision
standards (60601-1, 60601-2-22, EN ISO 14971, 60601-1-6), delete
60601-1-4, change Section 3.2 CSO 950 Specifications for Magnification
Ratio: 8X, 14X, 25X (5X and 38X optional), change Section 3.3 Optional
Accessories 600022 to 600018, change Section 3.1 SeLecTor Deux
System Specification for Adding Aiming Laser to SLT Mode
04 Mar. 2017 Change CE0434 to CE2460
05 Oct. 2018 Revise PM interval to 12 months
06 Aug. 2020 Change slit lamp bulb to LED, revise content format
07 Sep. 2021 Revise unpacking and receiving inspection, installation process,
error symptoms

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.

2.1 Product Classifications


The SeLecTor Deux Ophthalmic Laser is classified as:
 Class IIIB laser product as specified in the IEC standard 60825-1 (2007) and the USA 21 CFR
1040.10, 1040.11.
 Class I Type B Electromedical equipment as specified in the IEC Standard 60601.1.
 Class II device according to the FDA 21 CFR regulations.
 Class IIB Medical Device according to the MDD 93/42/EEC (as amended by 2007/47/EC).
 Electromagnetic compatibility (EMC) - tested and approved according to the requirements of the
international standard IEC60601.1.2.
The SeLecTor Deux Ophthalmic Laser has been designed to comply with the following standards:

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.

Pulse Maximum Energy Allowed for a Class IIIB Laser (mJ)


Single 30
Double 40
Triple 45

2.3.1 Nominal Ocular Hazard Distance (NOHD)


The Nominal Ocular Hazard Distance (NOHD) specifies that the distance between the equipment and a
patient’s eye, where the optical power from the equipment enters the dilated pupil of the patient, should be
less than or equal to the maximum permissible exposure (MPE) (≤ MPE), as specified in the standards. The
calculated NOHD for the SeLecTor Deux Laser is shown below. Therefore, when the laser is being used,
all persons who are closer to the laser than the distances mentioned above should be wearing eye protection.
Patients should have the untreated eye covered or protected from laser reflections.

Pulse NOHD (m)


Single (nominal) 11
Triple (maximum) 20

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.

2.4 Electrical Hazards


The SeLecTor Deux laser is designed to apply the International Standards for Medical Equipment. This
laser system is designed to operate with 3 terminal prongs for AC voltage where the third pin serves as the
earth-grounding prong.
WARNING! It is not safe to operate the SeLecTor Deux laser without an earth-grounding receptacle as
there will be a possible risk of electrical shock!
No cover or housing will need to be removed by the operator or user. Only authorized and trained Service
Technicians will be allowed to remove the cover or housing assembly to minimize the possibility of laser
radiation exposure and high current or voltage.

2.5 Safety Controls and Features


The system is equipped with numerous safety controls and features that are compliant with the standard
regulations. More details are shown below:

Figure 1 Safety controls and features.

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.

2.6 Product Labeling


All the labels on the SeLecTor Deux laser system comply with the requirements of various regulatory
standards that were previously mentioned.

Figure 2 Product safety labels.

Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 15 of 85
Item Description

Indicates the medical device’s model and serial


numbers.

Laser danger sign.

Laser information label.

Indicates the medical device Manufacturer, as


defined in EU Directives 90/385/EEC, 93/42/EEC,
and 98/79/EC as well as ISO 15223-1, 5.1.1.

Indicates the authorized representative in the


European Community as per ISO 15223-1.

Indicates the medical device’s manufactured date as


per ISO 15223-1, 5.1.3.
DANGER/CAUTION label. Risk of explosion if
used in the presence of flammable anesthetics,
vapors or liquids. Do not remove covers. Shock
hazard. Refer servicing to qualified service
personnel. For grounding reliability connect only to
with a “Hospital Grade receptable”. Complies to the
requirements of 21CFR, Chapter 1, Subchapter J.

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.

This product requires a 100-volt current.

WARNING label. Risk of fire. Replace only with


fuse as marked above.

Caution. Indicates the need for the user to review


the instructions for use for important cautionary
information such as warnings and precautions that
cannot, for a variety of reasons, be presented on the
medical device itself as per ISO 15223-1, 5.4.4.
Type B applied part. One of the six ways of applied
part, which indicates that the medical device does
not need to touch the patient when it is in use, or
that it can be removed immediately as per IEC
60417-2497.
Electronic copy of information on symbols for
medical device.

Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 17 of 85
Section 3 Product Specifications

3.1 General 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

Cooling system Air convection; passive


Item Dimensions (W x L x H, mm)
System 320 x 450 x 520
Single-column (U type) Ophthalmic
Dimensions 500 x 1000 x 880
Table
Dual Column (Ophthalmic Table) 620 x 1330 x 440
Portable Carrying Case 450 x 580 x 770
Item Weight (kg)
Weight System 21
Packed 28

Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 18 of 85
3.2 Treatment Laser Specifications

Item YAG SLT


Wavelength 1064 nm 532 nm
Neodymium Yttrium Aluminum
Laser type Frequency doubled Nd:YAG
Garnet (Nd:YAG)
Mode structure Fundamental; diffraction limited Frequency-doubled, diffraction limited
Mode of operation Q-switched (CQ-crystal)
 Single pulse: 0.2 to ≤ 15 mJ
Energy output  Double pulse: 10 to ≤ 25 mJ Single pulse: 0.2 to ≤ 2.6 mJ
 Triple pulse: 20 to ≤ 45 mJ
Energy adjustment Continuously variable across full energy range
1, 2, or 3 pulses each burst with the
Burst mode separation between pulses of 20 µs Single pulse only
(nominal).
 Continuously variable from
anterior
YAG Offset Focus N/A
-500 µm to posterior +500 µm.
 0, ± 150, 250, 500 µm
Pulse width 4 ns 3 ns
Repetition rate Up to 3 Hz
 In air: ≤ 2.5 mJ
Air breakdown N/A
 In liquid solution: ≤ 1.5 mJ
Spot size 8 µm (FWHM) 400 µm (FWHM)
Cone angle 16° < 3°
Focal length 107 mm
Ocular safety filter OD4 @ 1064 / 532 nm, double-coated / color-balanced
Safety class Class IIIB
Energy display
Better than ±20% of actual energy display
accuracy

Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 19 of 85
3.3 Aiming Laser Specifications

Item YAG SLT


Laser type Laser diode twin beam Laser diode one beam
Wavelength 635 nm (red)
Mode of operation Continuous wave (CW)
Output power Maximum of 200 µW Maximum of 400 µW
Power adjustment Continuously variable
Safety class Class I

3.4 Safety Filter 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

4.1 General Description


The acronym “LASER” stands for Light Amplification by Stimulated Emission of Radiation. The light beam
from a laser is a valuable tool for medical applications, which possesses the characteristics mentioned below:
 The beam from a laser is collimated. It does not diverge and can maintain a constant diameter over
a long distance. The laser beam can be focused to a very small spot with high energy and power
densities.
 The beam is monochromatic. It is a single wavelength beam that produces predictable and
reproducible tissue effects.
 The light waves are coherent. They are in phase with each other and do not interfere and/or generate
losses in energy.

4.1.1 YAG Mode: Ophthalmic YAG Laser 1064 nm


The YAG mode in the SeLecTor Deux laser system is an ophthalmic laser suitable for performing the
following clinical procedures:
 Posterior capsulotomy
 Pupillary membranectomy
 Iridotomy
This system has a wavelength of 1064 nm, which is in the near infrared spectrum and is invisible to the
human eye. The laser beam is generated from the laser aperture. Twin red aiming beams are used to position
and focus the treatment laser beam prior to delivering to the patient’s eye.
This system consists of a control box that houses the electronic control system and power supplies. The
laser system is housed in a slit lamp that is integrated into CSO model SL950, which is specifically designed
to adapt to the use of a laser delivery system. All the normal functions of a slit lamp are available to the
user when using the SeLecTor Deux laser system on a slit lamp unit.
When using the slit lamp as mentioned above, a microscope doctor safety filter (DSF) is required to protect
the user from unexpected reflections that can cause eye injury during the treatments. The DSF is mounted
in the beam path of the microscope.
The user must first confirm that the patient meets the treatment requirements (indications and
contraindications) before proceeding with any treatment. Typically, the operators or their assistants would
verify that the laser system is operating correctly before positioning the patient on the chinrest to avoid any
inconvenience to the patient. This verification process includes checking the laser output and alignment.
The user would normally use a contact lens during capsulotomy or membranectomy procedures in order to
direct the laser energy to the part of the eye that is being treated. The contact lens also helps to hold the eye
open and still during the procedure.
The operator must set the laser energy and number of pulses whenever the system is turned ON. It is the
operator’s responsibility to set the acceptable energy levels and pulse number. It is recommended to always
start with a lower energy and shorter pulses to reduce the risk of unintended patient injury. The laser settings
can be altered and saved by the operator to satisfy their preferences.

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.

Figure 3 YAG laser focusing for treatment.

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.

4.1.2 SLT Mode: Frequency-Doubled YAG Laser 532 nm


The SeLecTor Deux SLT Mode is a Nd:YAG laser providing Q-switched frequency-doubled pulses at a
wavelength of 532 nm for use in selective laser trabeculoplasty. The SLT treatment beam delivers a 3 ns,
0.2 to 2.6 mJ, adjustable single pulse of energy. The aiming and SLT treatment beams are coaxial with each
other and focused by the slit lamp objective lens to a 400 µm spot at the focal point of the lens.
This ophthalmic laser system is specifically designed to perform Selective Laser Trabeculoplasty (SLT),
which is a proven solution for managing open-angle glaucoma (OAG). More details about the system are
as follows:
 A lightweight, portable Q-switched frequency-doubled solid-state 532 nm laser.
 3 ns pulse duration confines thermally medicated damage to selectively targeted pigmented cells,
without creating collateral damage to surrounding tissue.
 Fixed 400 µm spot size facilitates effortless delivery of energy to the trabecular meshwork.
 Plugs into standard 110 V or 220 V electrical outlets.
 Nearly 5 years of clinically proven performance ensures high quality and reliability.
More information about the SLT clinical procedure can be found in Section 6 Clinical Use.

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:

No. Item Description


 The base is called the control box where the power supplies and mains
power switches are located.
1 Control box
 The slit lamp illumination controls are located on the front panel of the
control box.
 The slit lamp is mounted on top of the control box.
 All the optical modules, such as the laser beams, energy adjuster, and
2 Slit lamp display circuits, are located inside the slit lamp arm.
 There are 4 buttons on the display panel of the slit lamp arm which are used
to set the operating modes of the laser system.

The system operation is described below:


1. Make sure all cables are connected correctly. Connect the laser system to the main power outlet.
2. Power the electronics by turning the key switch to the ON position. Make sure the red emergency
stop button is in the release position, not pressed. The slit lamp illumination will light up.
3. Adjust the slit lamp illumination controls (intensity, color, slit, aperture) to the desired settings.
4. Turn the laser system ON by pressing the “LASER POWER” button on the control box.
 The “LASER POWER” indicator lamp will illuminate.
 The display on the front panel of the slit lamp arm will turn ON and it will show the following:
o Treatment laser type.
o Operation mode.
o Number of pulses.
o Total number of pulses and energy.
o Most recent energy setting.
 The system microprocessor controller will then perform internal self-tests to verify that the
machine is functioning properly.
 Should the system detect a fault at any time, it will automatically shut down to a safe state and
display an error code.
o Try rebooting the system to see if the error code can be resolved that way.
o Occasionally, the message “CAL” may be displayed after the restart. If this occurs, it means
the system is performing automatic calibration process, which will take approximately 10
minutes to complete.
o If the error code persists, contact the Manufacturer for service resolution.

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.

4.3 YAG Laser Controls

4.3.1 Front View Controls

Figure 4 YAG laser controls (front view).

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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:

“YAG OFFSET” Offset Procedure


21
dial Posterior (+) Capsulotomy and membranectomy.
YAG laser beam is set to the same
Zero (0) focus plane as the aiming beams and
slit lamp illumination.
Anterior (-) Iridotomy.
This button toggles the laser system between the YAG and SLT modes. When
this switch is pressed to go from YAG to SLT mode, the system will
YAG / SLT mode
22 automatically fire 5 internal test shots to warm up the SLT laser. However,
button
there will be no automatic internal test shots when going from SLT to YAG
mode.

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

4.3.2 Side View Controls

Figure 5 YAG laser controls (side view).

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

5.1 Introduction and Requirements


It is strongly recommended that the SeLecTor Deux laser system be installed by the Manufacturer or its
authorized Service Technicians to ensure that the system is installed, aligned, and calibrated correctly
according to the Manufacturer’s specifications. The user is responsible for ensuring that the laser system is
operating and operated appropriately, especially when the laser is moved or relocated.
Please use the installation procedures mentioned in this section as reference to ensure a successful
installation process. A copy of the complete and signed LIGHTMED SeLecTor Deux Service Report
(page 42) must be sent to the Manufacturer upon each installation completion. Both the installer and
customer are advised to keep a copy the Service Report for future reference. If the Service Report is not
sent to the Manufacturer, the Manufacturer reserves the right to decline any warranty claims.
When installing the SeLecTor Deux laser system, all safety precautions must be observed to prevent the
risk of exposure to laser radiation.
CAUTION! Always wear laser safety glasses that are suitable for the appropriate wavelength(s) to protect
your eyes!

5.2 Requirements Prior to Installation


 100 to 240 V, 50 or 60 Hz., AC mains power supply with an earth ground connection.
 A mains power cable is supplied but the connector may not suit the outlet that is available in the
treatment room. It is recommended to have a spare locally compatible cable available. The cable
assembly must be CE approved for use in EU countries.
 The laser system should be placed in a treatment room that provides a safe operating environment.
A dimly lit treatment room would be preferred.
 Position the laser in such a way that the treatment beam does not interact with any windows, doors,
reflective surfaces (mirrors, metals, etc.).
 A laser safety sign must be posted on the treatment door or entrance.
 The laser is designed to be compatible with a remote door interlock, which disables the system
when the treatment room door is opened. This feature should be wired by an electrician with the
instructions from the Manufacturer or an authorized Service Technician.
 The remote door interlock is provided with an interlock key, which enables the system normally
despite the treatment room door being open or closed. Please keep the interlock key inserted into
the control box If the remote door interlock feature is not used.
 If the laser needs to be relocated, please lock all the locking screws on the slit lamp to prevent it
from moving during transport. Moving the laser to a new facility that is not in walking distance is
a big task—the user should consider repacking the laser into its original foam packaging to prevent
system damage during the transport. Check the laser after transport for full functionality and
alignment accuracy.

Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 33 of 85
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:

Figure 6 Packing carton Figure 7 Portable carrying case.

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.

Figure 8 Packing carton _ top layer

 The middle layer contains the chinrest and accessories kit.

Figure 9 Packing carton _ middle layer

Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 35 of 85
 The component of the package 1

Figure 10 Packing carton _ middle layer _ package 1

 The component of the package 2

Figure 11 Packing carton _ middle layer _ package 2

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.

Figure 12 Packing carton _ bottom layer

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.

5.4 Tools and Equipment


The following tools and equipment are required for the Service Technician or installer to have in order to
carry out a complete installation or uninstallation of the SeLecTor Deux laser system. These items can also
be purchased from the Manufacturer:

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.

Figure 13 Install the cross slide shaft and gears (1)

(2) Insert the shaft into the hole of the slitlamp and laser, and screwing the gear to the cross slide
shaft.

Figure 14 Install the cross slide shaft and gears (2)

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.

Figure 19 cable connection (1)

(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.

Figure 20 cable connection (2)

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.

Figure 21 Install the cover for plastic rail

(2) The chinrest wire must be connected to the plug seat at the back of control box.

Figure 22 Install the chinrest and the wire plate (1)

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.

Figure 23 Install the chinrest and the wire plate (2)

(4) Insert the tailgate and tighten all four screws in order to make sure the electric wire don't
expose.

Figure 24 Install the chinrest and the wire plate (3)

(5) Install the binocular to the instrument


 Make sure the fool-proof design of the binocular and the instrument has matched. Install
the binocular to the instrument.

Figure 25 Install the binocular to the instrument

Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 43 of 85
 The top view of the SeLecTor Deux assembly.

Figure 26 Positioning the Slitlamp Cables Figure

 The side view of the SeLecTor Deux assembly.

Figure 27 Side 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.

Figure 28 The correct positioning of the 2 slit lamp cables

 Final assembly of the SeLecTor Deux laser system.

Figure 29 Final assembly of the SeLecTor Deux laser system

Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 45 of 85
5.6 System Verification

5.6.1 Minimum Air Breakdown Energy


This procedure can give an indication of the current performance of the treatment laser system. If the
treatment laser system is performing well in the ocular media of a patient, then it is reasonable to assume
that the laser performance is within the Manufacturer’s specifications. The performance can be affected by
several conditions:
 YAG cavity alignment, age, and performance.
 Cleanliness of optical components.
 Temperature and humidity levels in the treatment room.
 Repetition rate of laser shots.
Procedures:
1. Turn the laser ON. Set maximum energy at single pulse in YAG mode. Put the laser in TREAT
mode.
2. Ensure that the illumination tower is moved to one side to avoid interrupting the beam path.
3. Position the slit lamp so that the focus point for the system is in free air, with nothing blocking its
beam path. Do not attach a target plate or target rod to the unit.
4. When the laser is fired, a spark should be observed at the focus plane, approximately 107 mm in
front of the objective lens.
5. Reduce the laser energy until the lowest energy where approximately 50% of the laser shots
produce a spark in the air—this energy level is called the minimum air breakdown energy. Do not
fire the laser too rapidly, around 1 shot per 3 seconds is recommended. It is also advised to fire a
total of 10 shots at the same energy and make sure at least 5 shots produce sparks at that specific
energy.
6. The minimum air breakdown energy for systems of different ages is explained below.

Laser System Minimum Air Breakdown Energy (mJ)


New ≤ 2.5
Used ≤ 4.0

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).

Figure 30 Putting 2 red aiming beams together as one.

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.

5.6.3 Output Energy Calibration


This procedure can only be carried out by an authorized Service Engineer. If the energy is noticeably lower
or higher than normal, please contact the Manufacturer or local authorized Service Engineer for assistance.

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

Customer Signature Distributor (if known)

2. SERVICE DETAILS
Service Engineer Name Service Company Name
Service Date Service Location □ On-site □ LIGHTMED

Service Type □ Installation □ PM □ Fault repair □ Other: _____________________________

3. DEVICE USER SETTINGS


PARAMETERS EXAMPLE USER SETTINGS
Binoculars Diopter (Left / Right) -1 / -2
Magnifier 5 / 8 / 14 / 25 / 38X
Offset +500 / +250 / +150 / 0 / -150 / -250 / -500
Energy Setting YAG 1.0 mJ; SLT 1.5 mJ
Elevation of Tower Center
Slip Lamp Intensity 50%
Aiming Beam Intensity 100%
Slit Lamp Filter Color Blue / Red / Green / White
Slit Aperture 0.3 / 6 / 10 / 13 mm / Continuous
Slit Width 100% Open

4. SYSTEM DETAILS
□ YAG □SLT
Product Name Laser S/N Product Type
□ YAG & SLT

Warranty □ Yes □ No Warranty Expiry Date Tower Type Low Split

Table Type □ Single □ Dual column Table S/N Column S/N


Laser Cavity S/N Shot Count (Hex) Shot Count (Decimal)
Service Check □ Pass □ Fail Software YAG Min. ABD ___.___ mJ
YAG Voltage Before Voltage Cal. (V) Single Pulse: ________ Double Pulse: ________ Triple Pulse: ________
YAG Voltage After Voltage Cal. (V) Single Pulse: ________ Double Pulse: ________ Triple Pulse: ________

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

Next Recommended Action

System Status □ Working properly □ Faulty, not in use □ Part shortage □ Other: ___________________

Part Replaced Name Part Number Old Part S/N New Part S/N

LIGHTMED SeLecTor Deux Service Report

7. INSTALLATION CHECKLIST N/A □

PARAMETERS PASS FAIL


System Check
1. All parts received and checked OK. □ □

2. No damage to instrument packaging. □ □

3. Assemble slit lamp arm to control box. □ □

4. Cables are in the correct position, not crisscrossed or pinched. □ □

5. Cable plates / covers are equipped. □ □

6. Cables are connected to control box securely. □ □

7. Attach chinrest to control box. □ □

8. Finish system assembly. □ □

Slit Lamp Check


1. Illumination lamp controls check OK. □ □

2. 4-filter wheel settings check OK. □ □

3. Slit width fully opens 5 aperture settings check OK. □ □

4. At 13 mm (biggest) aperture setting, slit forms a full circular spot. □ □

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. □ □

6. There is no illumination when the slit is fully closed. □ □

7. A narrow slit can rotate ± 90° vertically. □ □

8. Eyepieces fit firmly into binoculars. □ □

9. Eyepieces can be fully adjusted and set to correct diopters. □ □

10. Vertical slit lamp movement with joystick checks OK. □ □

11. Side slit lamp movement with joystick checks OK. □ □

12. Forward slit lamp movement with joystick checks OK. □ □

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. □ □

2. Chinrest height is adjustable, vertical movement is smooth. □ □

3. Chinrest handles are fixed firmly to posts. □ □

4. Fixation lamp is operational. □ □

5. Fixation lamp can be moved in any direction. □ □

Laser System Check


1. LASER POWER indicator illuminates when LASER POWER button is pressed. □ □

2. System performs test shots upon system start-up. □ □

3. System software version is displayed upon system start-up. □ □

4. No error message is displayed. □ □

5. Energy is displayed. □ □

6. When the energy is adjusted, the display changes. □ □

7. All the button on the display panel are functional. □ □

8. Two red YAG aiming beams are visible. □ □

9. YAG aiming beams intensity is fully adjustable. □ □

10. SLT aiming beam intensity is fully adjustable. □ □

Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 51 of 85
LIGHTMED SeLecTor Deux Service Report

8. OPTICAL ALIGNMENT (USER MODE)


PARAMETERS PASS FAIL ADJUSTED N/A
1. Set Diopter Settings □ □ □ □

2. Center of Rotation □ □ □ □

3. Background Focus □ □ □ □

4. YAG Burn Aligned to Illumination Slit □ □ □ □

5. YAG Aiming Beam Aligned to YAG Burn □ □ □ □

6. YAG Offset □ □ □ □

7. SLT Aiming Beam Aligned to YAG Burn □ □ □ □

8. SLT Treatment Beam Aligned to SLT Aiming Beam □ □ □ □

9. Clean Lens □ □ □ □

9. VERIFY ENERGY DISPLAYS (SERVICE MODE)


PARAMETERS PASS FAIL ADJUSTED N/A
1. YAG Preset Energy is within ±20% of External Meter Energy □ □ □ □

2. YAG Internal Energy is within ±20% of External Meter Energy □ □ □ □

3. YAG Internal Energy is within ±20% of Preset Energy □ □ □ □

4. Min. YAG AD Value = 11 □ □ □ □

5. Max. YAG AD Value = 254 □ □ □ □

6. SLT Preset Energy is within ±20% of External Meter Energy □ □ □ □

7. SLT Internal Energy is within ±20% of External Meter Energy □ □ □ □

8. SLT Internal Energy is within ±20% of Preset Energy □ □ □ □

9. Min. SLT AD Value = 28 □ □ □ □

10. Max. SLT AD Value = 254 □ □ □ □

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. = ______ □ □ □ □

12. VOLTAGE CALIBRATION: < 700 VDC (SPECIAL MODE)


THE BEFORE & AFTER VOLTAGES ARE RECORDED ON
VOLTAGE CAL PASS VOLTAGE CAL FAIL
THE 1ST PAGE OF THIS REPORT
□ □ □

13. YAG / SLT MODE BURNS (USER MODE)


Insert YAG mode burn picture(s) here: Insert SLT mode burn picture(s) here:

Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 53 of 85
LIGHTMED SeLecTor Deux Service Report

14. COMPLETION CHECKLIST


COMPLETE
PARAMETERS FAIL NOTES
D
1. Record Device User Settings □ □

2. Installation Checklist □ □

3. Optical Alignment □ □

4. Verify Energy Displays □ □

5. YAG 1064nm Energy Calibration ±20% Tolerance □ □

6. SLT 532nm Energy Calibration ±20% Tolerance □ □

7. Voltage Calibration □ □

8. YAG/SLT Mode Burns □ □

9. Return Device to Initial User Settings □ □

INTERNAL USE ONLY


RMA Number Service Order Number
Reviewer Name Date Reviewed

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:

No. Item Description


No laser power is required. Only the slit lamp will be turned ON
1 Slit lamp microscope
and used.
 YAG mode:
o Posterior capsulotomy.
Ophthalmic laser o Pupillary membranectomy.
2
(explained below) o Iridotomy.
 SLT mode:
o Selective laser trabeculoplasty.

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:

Indications for posterior capsulotomy (YAG) use:


 The patients may be of any age or sex.
 The eye must have its natural lens removed.
 The eye should be medically stable.
 Visual acuity should be worse than 20/30.
 Visual acuity should be measurably hampered by the membrane.
 Pupillary Membranectomy is limited to treatment of membrane in the pupillary space.

Contraindications for posterior capsulotomy (YAG) use:


 Eyes that have no potential visual function.
 Corneal cloudiness, lesions, scars, or edema that prevent accurate viewing of the target.
 Cloudy intraocular media that will affect the laser beam absorption.
 Ocular inflammation.
 Uncontrolled glaucoma.
 Inability to fixate normally can cause possible damage to adjacent intraocular structure.
 There is a risk of fracture of glass IOL.
 Posterior chamber IOLs are more prone to damage due to:
o The gap between the IOL and the capsule is too small.
o Many shots are used, and the total energy is larger.
 If there is a high risk of retinal detachment, absolute minimum number of shots should be used.

Warnings for posterior capsulotomy (YAG):


 Transient or continued elevation of intraocular pressure (IOP) can occur as a result of these
procedures.
o Patients should be monitored carefully during the post-operation period. If the IOP is more
than 5 mm Hg above baseline, then treatment should be given. The potential use of high
energy levels and large number of pulses when treating pupillary membranes can cause an
acute increase in the IOP.
o If the patient cannot be checked until the next day and has a baseline pressure of more than
20 mm Hg or has glaucoma, the prophylactic treatment should be given. Allergies and
medical history should be reviewed. If there are no contraindications such as asthma or

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.

6.2 Pupillary Membranectomy (YAG)


The Pupillary Membranectomy approach is similar to that of Posterior Capsulotomy, except that the
membrane has no elastic properties. The laser is aimed directly at the posterior capsule with only a small
posterior YAG offset focus, unless the YAG energy is set high in which case, it may be appropriate to
increase the offset. The technique of looking for tension lines does not apply. When a membrane is very
opaque and has no elastic properties, treatment with higher pulse energy may be required. Typically, lots
of shots at very high power are required. A contact lens should also be used. In some cases, several hundred
shots are required. Care must be exercised as prolonged firing may cause prolonged inflammation and
elevated IOP. Post-operative care is indicated.

6.3 Iridotomy (YAG)


This system offers the alternative of opening or putting a hole in the iris by cutting as a result of photo
disruption rather than burning when using photocoagulation. The following are the indications,
contraindications, warnings, and recommendations for using this laser on phakic, pseudo-phakic, or aphakic
patients:

Indications for iridotomy (YAG) use:


 The patients may be of any age or sex.
 The eye must be at risk of some form of pupillary block glaucoma.
 The pupillary block should be potentially responsible for glaucomatous damage to the optic nerve
as a result of the IOP levels that are known to cause such damage.
 For treatment of patients where photocoagulation iridotomy has been unsuccessful.

Contraindications for iridotomy (YAG) use:


 Eyes that have no potential visual function.
 Cloudy intraocular media or opacities of the media such that visualization of the iris is inadequate.
 Eyes that do not have glaucoma with pupillary block.
 Eyes that have a glass IOL as there is a risk of glass fracture.

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.

Warnings for iridotomy (YAG):


 An acute increase in pressure following treatment is common. Ideally, the patient should be
checked regularly up to 4 hours following the procedure. Treatment should be given if the pressure
rise is more than 5 mm Hg above the baseline.
o Allergies and medical history should be reviewed. If there are no contraindications such as
asthma or 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 The decision to use additional medical treatment in the event of IOP increase should be
based on each individual patient’s situation. Any pre-existing conditions must be
considered.
o The use of a few drops of apraclonidine pre- and post-laser can reduce the rate of acute
IOP.
 Lens damage is possible from performing YAG laser iridotomies and opacification of the
underlying anterior lens capsule that is removed (the opacities cleared without formation of a
cataract). The risk of damage is increased where high energy levels (greater than 10 mJ and more
than triple burst mode) are used, inaccurate laser focusing takes place, and laser energy is applied
directly to the lens through the pupil. Also, if a hole already exists in the iris or if there is apposition
of the peripheral iris to the lens, then applying more laser energy can cause lens damage. These are
the recommendations that may reduce the likelihood of damaging the lens:
o Use a recommended contact lens when performing the procedure.
o Maintain precise focusing and alignment of the aiming beams on the iris treatment site.
o Set the correct anterior (-) YAG laser offset focus for the energy used. This ensured that
the spot size will be larger on the treatment site than if set to zero (0) offset. The more
anterior (-) offset, the larger the spot size at the treatment site. For example, at -500 µm,
the spot size at treatment site would be around 150 µm.
o Always use the lowest possible energy and minimum number of pulses per burst for each
treatment shot.
o Select an iris treatment site that is on the periphery and the site should be located under the
upper eyelid whenever possible.
o Optimize the view of the iris by setting up the slit lamp controls correctly.
o Avoid treatment at a site that already has a totally or partially patent hole.
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 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.

Recommendations for iridotomy (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. It is typical to set
an anterior (-) offset when performing iridotomy procedures to avoid damaging the lens or
lens capsule when the hole is produced in the iris.
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 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.
o The YAG laser should be focused on or near iris blood vessels as the shock wave may
produce bleeding.
o To avoid induced beam astigmatism, the laser shot should enter the eye at no more than
30° from the visual axis.
o Good patient fixation should be maintained.

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.

Indications for SLT use:


 Good candidates for SLT include primary-open angle, normal tension, pseudoexfoliation, or
pigmentary glaucoma patients who:
o Wish to use SLT as a primary glaucoma treatment.
o Find it challenging to take glaucoma medications due to time or financial constraints,
non-compliance, and quality-of-life issues.
o Are currently undergoing drug therapy and need to further reduce IOP without adding
drugs.
o Wish to keep the number of drugs to a minimum.
o Do not tolerate drugs due to their adverse effects.
o Experience loss of the pressure-lowering effects of drug therapy.
o Have had failed argon laser trabeculoplasty (ALT) experience.

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).

Recommendations for SLT use:


 Pre-treatment:
o Alpha-adrenergic antagonist / pilocarpine.
o Topical anesthetic.
 During treatment:
o Goldmann, Thorpe, or Latina lens (0° magnification).
o Focus aiming beam to target the entire height of trabecular meshwork.
o Set SLT laser to 0.8 mJ (average) and then increase in 0.1 mJ increments until champagne
bubbles appear approximately 50 to 70% of the time.
o Approximately 50 shots are placed onto the trabecular meshwork in the same patterns as
ALT.
 Post-treatment:
o Alpha-adrenergic antagonist.
o Pilocarpine.
o Topical steroid or non-steroidal anti-inflammatory drugs (NSAID) for 3 to 5 days
(optional).
o One-hour IOP check after treatment.
o Regular follow-up routine.

Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 65 of 85
Section 7 Troubleshooting

7.1 Error Symptoms


The complete list of this system’s error symptoms as well as the corrective actions are described below. If
any of these symptoms persists, please call the Manufacturer or local authorized Service Engineer.

No. Item Description Corrective Action


This system requires 100 – 230 VAC,
50/60 Hz, single phase AC mains
voltage. The power cable plugs into the
Mains back of the control box. Ensure that the Contact the Manufacturer or local
1 electrical power cable is securely plugged in to authorized Service Engineer for
power both the control box and the mains power assistance.
supply. The laser system should only be
used with a 3-pin mains power supply
cable that is properly grounded.
The 2 mains power fuses are in the input
power socket on the back of the control
box, as below:
 Replace the blown fuse. Spare fuses
Fuse Rating at are provided with each laser system.
Operation (V)
Mains 250 V (A)
2  If the fuse is replaced, but the system
power fuses 100 – 120 TH3.15 fails again, contact the Manufacturer
200 – 230 TH2.5 or local authorized Service Engineer
for assistance.
If the fuse blow, then it normally
indicates a failure inside the system.

If the laser system cannot be operated,


then it means that the control switches are
not functioning. If there is a constant  Make sure that these connections are
Remote warning tone, then it is probable that the secured.
3 door bypass connector on the back of the  Otherwise, contact the Manufacturer
interlock control box or the switch/cable assembly or local authorized Service Engineer
to the door interlock are not connected for assistance.
properly, resulting in an open circuit that
is causing the problem.

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.

Not illuminated.  Verify that the mains power is


connected to the laser unit, the key
switch is in the ON position, the
red emergency stop button is
released, and the fixation lamp
Fixation cable is connected to the back of
5
lamp the control box.
 If the fixation lamp needs to be
replaced, contact the Manufacturer
or local authorized Service
Engineer for assistance.

7.2 Error Codes


If a fault, error, or warning condition is found by the microprocessor during the start-up, special mode, or
normal operation of the laser system, then the laser system will go into STANDBY mode and an error
message will be shown on the front panel display. The laser system is disabled and cannot be used when
this occurs.
If an error message is regularly shown on the display, then an authorized Service Engineer must check the
laser system and adjust accordingly. Under no circumstances should unauthorized or untrained
personnel attempt repairs. Refer to Section 10 for warranty details and conditions.
A complete list of the error codes for SeLecTor Deux laser system is as follows. If any of these symptoms
persists, please call the Manufacturer or local authorized Service Engineer.

Error Code Description Corrective action


The shutter assembly has 2 sensors that detect the correct
position of the shutter. During the normal operation of the
shutter the sensor outputs must be correctly detected for the
Err 01:
open and closed positions. If during the operation of the
Shutter error  Reboot the system.
system an incorrect position of the shutter, that is opened
 If the error code persists,
or closed, is detected then this error message is
contact the Manufacturer
displayed.
or local authorized Service
Every time the Laser is fired the Control System checks the
Engineer.
Err 02: number of Laser pulses and the energy delivered. If any
Pulse detector shots are fired and the measured energy is more than 0.1
error mJ but no Laser Pulse is detected then this error
message will be displayed.

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

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions


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.
Emissions test Compliance Electromagnetic Environment – Guidance

The Ophthalmic YAG Laser, SeLecTor Deux uses RF


energy only for its internal function. Therefore, its RF
RF emissions CISPR 11 Group 1
emissions are very low and are not likely to cause any
interference in nearby electronic equipment.

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.

Separation distance according to frequency of transmitter (m)


Rated Maximum
Output Power of 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz
Transmitter (W)
d = 1.2 √𝑷 d = 1.2 √𝑷 d = 2.3 √𝑷
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance
(d) in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where
(P) is the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for 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.

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

Electrostatic Floors should be wood, concrete or


±6 kV contact ±6 kV contact ceramic tile. If floors are covered with
discharge (ESD)
±8 kV air ±8 kV air synthetic material, the relative humidity
IEC 61000-4-2 should be at least 30%.
±2 kV for power supply ±2 kV for power supply
Electrical fast
lines lines Mains power quality should be that of a
transient/burst typical commercial or hospital
±1 kV for input/output ±1 kV for input/output
IEC 61000-4-4 environment.
lines lines

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.

<5 % UT (>95 % dip in <5 % UT (>95 % dip in


UT) → for 0.5 cycle UT) → for 0.5 cycle Mains power quality should be that of a
typical commercial or hospital
environment. If the user of the
Interruptions and 40 % UT (60 % dip in 40 % UT (60 % dip in ophthalmic laser, LIGHTLas SeLecTor
voltage variations UT) → for 5 cycles UT) → for 5 cycles Deux, requires continued operation
on power supply during power
input lines
70 % UT (30 % dip in 70 % UT (30 % dip in mains interruptions, it is recommended
IEC 61000-4-11 UT) → for 25 cycles UT) → for 25 cycles that the ophthalmic laser, LIGHTLas
SeLecTor Deux, be powered from an
uninterruptible power supply or a
<5 % UT (>95 % dip in <5 % UT (>95 % dip in battery.
UT) → for 5 sec UT) → for 5 sec

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

Guidance and manufacturer’s declaration – electromagnetic emissions


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.
Electromagnetic environment –
Emissions test Compliance
guidance
The Ophthalmic YAG Laser,
SeLecTor Deux uses RF energy only
RF emissions for its internal function. Therefore, its
Group 1
CISPR 11 RF emissions are very low and are not
likely to cause any interference in
nearby electronic equipment.
RF emissions
Class B The Ophthalmic YAG Laser,
CISPR 11
SeLecTor Deux is suitable for use in
Harmonic emissions all establishments, including
Class A domestic establishments and those
IEC 61000-3-2
directly connected to the public low-
Voltage fluctuations/ voltage power supply network that
supplies buildings used for domestic
flicker emissions Complies
purposes.
IEC 61000-3-3

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

0,01 0,12 0,12 0,23


0,1 0,38 0,38 0,73
1 1,2 1,2 2,3
10 3,8 3,8 7,3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in metres (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for 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.

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

Floors should be wood, concrete


Electrostatic or ceramic tile. If floors are
±6 kV contact ±6 kV contact
discharge (ESD) covered with synthetic material,
±8 kV air ±8 kV air the relative humidity should be at
IEC 61000-4-2
least 30 %.
±2 kV for power ±2 kV for power
Electrical fast
supply lines supply lines Mains power quality should be
transient/burst that of a typical commercial or
±1 kV for input/output ±1 kV for input/output hospital environment.
IEC 61000-4-4
lines lines

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
IEC 61000-4-5 ±2 kV line(s) to earth ±2 kV line(s) to earth hospital environment.

<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

Power frequency Power frequency magnetic fields


(50/60 Hz) should be at levels characteristic
3 A/m 3 A/m of a typical location in a typical
magnetic field commercial or hospital
IEC 61000-4-8 environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.

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

Conducted RF 3 Vrms d = 1,2


3 Vrms d = 1,2 80 MHz to 800 MHz
IEC 61000-4-6 150 kHz to 80 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
Radiated RF 3 V/m transmitter manufacturer and d is the
3 V/m
IEC 61000-4-3 80 MHz to 2,5 GHz recommended separation distance in metres (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,a
should be less than the compliance level in each
frequency range.b
Interference may occur in the vicinity of
equipment marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, 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.

No. Item Part Number


1 Abraham capsulotomy lens 600036
2 Abraham iridectomy lens 600035
3 Bearing plate for tonometer mounting (type T900) 600027
4 Beam splitter for YAG laser 600018
5 Observation microscope for assistant (use with beam splitter) 600023
6 870z tonometer mount 600163
7 Adapter for video camera (requires beam splitter) 600025
8 Adapter for camera (requires beam splitter) 600024
9 Motorized table with central drive column (includes top) 600015
10 Motorized table with side drive column (for wheelchair access) 600016
11 Safety glasses OD4 @ 1064 / 532 nm 620032
12 Slit lamp LED XLamp® XM-L2 2.85V 10W YL52D101
13 Fixation lamp bulb for chinrest 240014
14 Chinrest papers 600026
15 Model eye kit YL0508
16 Model eye membranes (bag of 25) 540010
17 Adjustable headband for chinrest YL6024, YL6025
18 CPU PCB with software YL4184
19 Display PCB assembly YL4483
20 DC PSU module 230035
21 Laser PSU (without cover) YL2100
22 Dimmer PCB assembly YL2400
23 Arc lamp trigger module YL4900
24 YAG laser cavity module YL4300
25 YAG energy adjuster module YL4490
26 SLT energy adjuster module YL4480

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

The mathematical units used in this Manual are as follows:

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

Appendix III References

The ophthalmology references used in this Manual are as follows:

1) Pulsed YAG laser surgery. Aron Rosa; Slack, N.J, 1983.

2) Use of Neodymium-YAG Laser to Open the Posterior Capsule After Lens Implant Surgery, A
Preliminary Report. Aaron-Rosa DS, Aaron JJ, et al; J. Am Intraocular Implant Soc. 6:352-4, 1980.

3) Neodymium-YAG laser for posterior Capsulotomy. Terry AC, Stark W, et al; l Am J. Ophthalmol, 96:
716-20, 1983.

4) Ophthalmic Procedure Assessments Nd:YAG Photodisruptors. American Academy of Ophthalmology;


Ophthalmology Instrument and Book Issue. 1989 pgs 46-51.

5) National Outcomes of Cataract Extraction Increased Risk of Retinal Complications Associated with
Nd:YAG Laser Capsulotomy. Javitt JC. MD, Tielsch J.M. Phd, et al; Ophthalmology, Vol 99, Num 10,
Oct 1992 pp 1487-1498.

6) Incidence of retinal Detachment following Nd:YAG Capsulotomy after Cataract Surgery.


Westenbrugger JA, MD, Gimbel HV, MD, et al; Journal of Cataract and Refractive Surgery, Vol 18,
July 1992 pp 352-355.

7) Nd:YAG laser in ophthalmology. R F Steinert and C A Puliafito; W B Saunders Co., 1985.

8) Nd:YAG laser microsurgery: fundamental principles and clinical applications. F Fankhauser and P Rol;
International Ophthalmology Clinics, Vol 25, No 3, 1985. Little Brown & Co., Mass.

9) Ocular Hypertension Following Nd:YAG Laser Capsulotomy: A Potentially Blinding Complication.


Vine, Andrew K., M.D; Ophthalmic Surgery 15:283-284; 1984.

Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 83 of 85
10) Long Term Follow-up of Nd:YAG Laser Posterior Capsulotomy. Keates, Richard H., M.D., Steinert,
R.D., M.D., Puliafito, C.A., M.D., Maxwell, S.K., M.S; Am. Intraocular Implant Soc. J. 10:164-168,
1984.

11) Nd:YAG Laser in Ophthalmology. RF Steinert and CA Puliafito; WB Saunders Co. 1985.

12) Laser Therapy of the Anterior Segment. L Schwartz, G Spaeth and G Brown; Thorofare, NJ. Charles
Slack Inc. 1984.

13) Long-term results of Nd:YAG iridotomy and indications deriving from it. M Buchner, B Gloor and Y
Robert; Klin Monatsbl Augenheilkd, 1986.

14) The Q Switched Laser: Principles and clinical results. F Fankhouser; In: Trokel SL (ed) YAG Laser
Ophthalmic Microsurgery. Norwalk, CT: Appleton-Century-Crofts, 1983.

15) Histopathological Characteristics of neodymium YAG Laser iridotomy in the human eye. MF Goldberg,
MO Tso and M Mirolovich. Br J Ophthalmol, 1987.

16) Laser Iridectomy: A controlled study comparing argon and neodymium: YAG, MR. Moster, LW
Schwartz and GL Spaeth, et al; Ophthalmology, 1986.

17) Iridotomy is safer and easier with YAG than argon. Al Robin; OSN, 1997.

18) A comparison of Nd:YAG and argon laser iridotomies AL Robin and IP Pollack; Ophthalmology, 1984.

19) Selective Laser Trabeculoplasty: A Better Alternative, Karim F. Damji, MD, FRCSC, MBA, p646-651,
Surv Ophthalmol 53 (6) November-December 2008.

20) Excimer laser trabeculotomy: a new, minimally invasive procedure for patients with glaucoma, Sonja
Wilmsmeyer, Heiko Philippin, Jens Funk, Graefe’s Arch Clin Exp Ophthalmol 244:670-676, 2006

21) Selective laser trabeculoplasty retreatment after prior argon laser trabeculoplasty: 1- year results,P716-
719, Catherine M. Birt, MD, FRCSC, CANJ OPHTHALMOL- VOL.42, NO.5, 2007

22) Mechanisms of the Glaucoma, Joyce Tombran-Tink, PhD, Colin J, Branstable, DPhil, M. Bruce
Shields, MD, 2008

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Ophthalmic YAG Laser SeLecTor Deux. – Operator’s Manual Rev. No. 6 Page 85 of 85

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