YL0401-2167 - Operator's Manual For YAG SYL9000

Operator's Manual
Ophthalmic YAG Laser System

Operator’s Manual
For The
Lpulsa SYL9000
Ophthalmic YAG Laser System
2460
Directive 93/42/EEC
Doc. No.: YL0401
Rev. No.: 21
Ophthalmic YAG Laser System – Operator’s Manual Rev. No. 21 Page 2 of 67

Operator’s Manual for the Ophthalmic YAG Laser System
Clinicians and/or Doctors should ensure that they are adequately knowledgeable of the
operation or training prior to using the Ophthalmic YAG Laser System 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
____________________________________________________________________________
Document Title: Operator’s Manual for the Ophthalmic YAG Laser System
Document Number: YL0401
Document Revision History:
Draft 01 Aug. 1998 Draft prepared

Draft 02 Nov. 1998 Add Iridotomy Indications for Use
01 Jan. 1999 First release
02 Apr. 1999 Second release; update drawings and add details
03 Jul. 1999 Third release; update specifications of aiming
04 Jun. 2000 Fourth release; update CE mark
05 Dec. 2000 Fifth release; update to include Premio options

06 Mar. 2001 Sixth release; update for software version 1.1
07 Jan. 2002 Update drawings
08 Mar. 2003 Update drawings
09 Feb. 2004 Modify Safety Glass Description, delete Warranty Statement,
IEC Standard revision change
10 Jan. 2005 Change EU Representative to ALFA in Italy, slit lamp Leica Xcel
200 change to CSO 950
11 Apr. 2006 Change control box for AC power voltage full range from 100 to
230 VAC, 50/60 Hz, repetition rate 2.5 Hz single pulse, add Error
10 message for software version 2.0
12 Sep. 2006 Change EU Representative to MT Promedt Consulting GmbH in
Germany
13 Oct. 2007 Change IEC825.1 to TEC60825 and 6.3.2. Iridotomy (hole in the
iris)
14 Mar. 2008 Delete the wrong description about the voltage changer
15 Jun. 2009 Change EU Representative to Medical Device Safety Service
GmbH
16 Jan. 2010 Change CE0197 to CE0434 and add information symbol
17 Jun. 2010 93/42/EEC as amended by 2007/47/EC, update standards, update
manufacturer’s address, update labeling to comply with
IEC60825-1, FDA 21 CFR 1040.10, 1040.11
18 Oct. 2014 Change Section 2.2 Conformance to Standards, update the
revision standards (60601-1, 60601-2-22, EN ISO 14971), delete
60601-1-4, change Section 3.2 CSO 950 specifications for
Magnification Ratio (8X, 14X, 25X with 5X and 38X as options),
change 3.3 Optional Accessories 600022 to 600018
19 Mar. 2017 Change CE 0434 to CE 2460
20 Oct. 2018 Revise PM interval to 12 months
21 Aug. 2020 Change slit lamp bulb to LED, revise content format

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 .......................................................................................................10
2.3.1 Nominal Ocular Hazard Distance (NOHD) ..........................................................11
2.3.2 Avoid Exposure to Laser Beams ........................................................................11
2.4 Electrical Hazards ....................................................................................................11
2.5 Safety Controls and Features .................................................................................12
2.6 Product Labeling .....................................................................................................15
2.6.1 Control Box Labels ..............................................................................................15
2.6.2 Slit Lamp Labels ..................................................................................................17
Section 3 Product Specifications ....................................................................................18
3.1 General Specifications ............................................................................................18
3.2 Treatment Laser Specifications ..............................................................................18
3.3 Aiming Laser Specifications ...................................................................................19
3.4 Slit Lamp Specifications .........................................................................................19
3.5 Safety Filter Specifications .....................................................................................20
Section 4 Principles of Operation....................................................................................21
4.1 General Description.................................................................................................21
4.2 Laser System Operation .........................................................................................23
4.3 YAG Laser Controls.................................................................................................26
4.3.1 Front View Controls .............................................................................................26
4.3.2 Side View Controls ..............................................................................................29
Section 5 Installation ........................................................................................................31
5.1 Introduction and Requirements ..............................................................................31
5.2 Requirements Prior to Installation .........................................................................31
5.3 Unpacking and Receiving Inspection.....................................................................32
5.4 Tools and Equipment ..............................................................................................34
5.5 Installation Process .................................................................................................34
5.6 System Verification .................................................................................................37
5.6.1 Minimum Air Breakdown Energy ........................................................................37
5.6.2 Optical Alignment ................................................................................................38
5.6.3 Output Energy Calibration ..................................................................................40
LIGHTMED YAG Service Report.............................................................................................41

Section 6 Clinical Use ......................................................................................................45
6.1 Posterior Capsulotomy ...........................................................................................46
6.2 Pupillary Membranectomy ......................................................................................49
6.3 Iridotomy ..................................................................................................................50
Section 7 Troubleshooting...............................................................................................54
7.1 Error Symptoms ......................................................................................................54
7.2 Error Codes ..............................................................................................................55
Section 8 User Maintenance ............................................................................................57
Section 9 Warranty Details and Conditions ....................................................................58
Section 10 EMC Test Tables ..............................................................................................59
Appendix I Optional Accessories ......................................................................................62
Appendix II Glossary ...........................................................................................................63
Appendix III References .......................................................................................................65

List of Drawings / Figures
Figure Item Page
1 Safety Controls and Features 12
2 Control Box Safety Labels 15
3 Slit Lamp Labels 17
4 YAG Laser Focusing for Treatment 22
5 YAG Laser Controls (Front View) 26
6 YAG Laser Controls (Side View) 29
7 Packing Carton for the Ophthalmic YAG Laser System Assembly 32
8 Portable Carrying Case for the Ophthalmic YAG Laser System 32
9 Unpacking the Accessories Kit 33
10 Equipping the Cross-Slide Shaft 34
11 The Correct Positioning of the 2 Slit Lamp Cables 35
12 Side View of the Ophthalmic YAG Laser System Assembly 36
13 Top View of the Ophthalmic YAG Laser System Assembly 36
14 Final Assembly of the Ophthalmic YAG Laser System 37
15 Putting 2 Red Aiming Beams Together as One 39
16 YAG Burn Mark Aligned to the Merged Aiming Beams and Illumination Spot 40
Record Sheet
No. Item Page
1 LIGHTMED YAG Service Report 41
Appendix
No. Item Page
1 Optional Accessories 62
2 Glossary 63
3 References 65

Section 1 Introduction
This manual is intended to provide the Operator with an overview of the operation and safety
requirements for the Ophthalmic YAG Laser System. 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 Ophthalmic YAG Laser System, the operator should read this manual carefully
and pay attention to the sections of safety, operation, and maintenance.

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 Ophthalmic YAG Laser System 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 CFR21 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 Ophthalmic YAG Laser System has been designed to comply with the following standards:
Standards Description
• EN 60825-1:2007
Laser • USA 21 CFR 1040.10, 1040.11 (1997)
• EN 60601-1-2-22:2013
• 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

2.2 Warnings and Precautions
The following warnings and precautions apply to the Ophthalmic YAG 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 OD5 or higher that accommodates 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.
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 Ophthalmic YAG 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 greater than or equal to 5 (≥ 5) and the
wavelengths of 1064 nanometers (nm) is also specified on it. The safety glasses specifications
are typically shown in this format: OD5+ @ 1064 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 Ophthalmic YAG 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). 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.
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 (i.e. less than a Class I laser output).
The calculated NOHD for the Ophthalmic YAG Laser is as follows:
Pulse NOHD (m)

Single (nominal) 11
Triple (maximum) 20
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.
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 Ophthalmic YAG 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 Ophthalmic YAG 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.
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.
Emergency stop
1 It has a bright red button that locks down when pressed, where all
button
power is cut off from the 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 the key is in the ON position, the key cannot be removed. The
2 Key switch
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
“LASER
approximately a 7-second delay, allowing for laser emissions to be
4 POWER”
possible. Power is immediately removed when the button is pushed
ON/OFF button
to turn OFF. By default, 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
indicator laser 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
Shutter adjuster system is on TREAT mode and the fire button is pressed. At this point,
6 (inside front the shutter momentarily opens for less than 100 milliseconds (ms) to
panel housing) allow the treatment 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
7 Mode Set button
fire button and the shutter is always closed. The TREAT mode is the
only mode that will allow external laser emissions.
STANDBY When this indicator is illuminated, the laser system is set to STANDBY
8
mode indicator mode where no external laser emission will be delivered.
When this indicator is illuminated, the laser system is in TREAT mode
TREAT mode and the laser energy can be delivered to the patient. If the laser
9
indicator system is not operated for a period of 5 minutes, the laser system will
automatically toggle to STANDBY mode.
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,
Remote door an audible warning tone can be heard, and the laser system will toggle
10
interlock to STANDBY mode to prevent 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
“TEST” Fire laser but keep the shutter closed. This provides the user a safe way
11
button to check the 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
“TEST” Fire
12 system performs an automatic test fire to verify the new energy level.
display
The energy is then displayed on the display panel.

Whenever the energy control is adjusted or the number of pulses is
Joystick fire
13 changed, the laser system performs an automatic test fire to verify the
button checks
new energy 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
Ophthalmic YAG Laser System:
• When the Ophthalmic YAG 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 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:
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 Ophthalmic YAG 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 Ophthalmic YAG Laser System comply with the requirements of various
regulatory standards that were previously mentioned.
2.6.1 Control Box Labels

All the safety and control labels on the control box are shown below:
Figure 2: Control box safety labels.

Item Description
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.
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.
2.6.2 Slit Lamp Labels

All the safety and control labels on the slit lamp are shown below:
Figure 3: Slit lamp labels.
Item Description
Indicates the medical device’s model and serial

numbers.

Section 3 Product Specifications
3.1 General Specifications

Item Description
• 100 to 240 VAC
Electrical
• 50/60 Hz
input
• 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)
Relative Atmospheric
Temperature
Item Humidity Pressure
Transport, Range (°C)
Range (mbar)
Operating,
30 to 85% non-
and Storage Operating 20 to 40 800 to 1,060
condensing
Requirements
Transport -10 to 70 Up to 95% non-
500 to 1,060
Storage -10 to 55 condensing
Cooling
Air convection; passive
system
Item Dimensions (W x L x H, mm)
System 320 x 450 x 520
Single-column (U type)
500 x 1000 x 880
Dimensions Ophthalmic Table
Dual Column
620 x 1330 x 440
Ophthalmic Table
Portable Carrying Case 450 x 580 x 770
Item Weight (kg)
Weight System 21
Packed 28
3.2 Treatment Laser Specifications

Item Description
Wavelength 1064 nm
Laser type Neodymium Yttrium Aluminum Garnet (Nd:YAG)
Mode structure Fundamental; diffraction limited
Mode of operation Q-switched (CQ-crystal)
Pulse Mode Energy Output (mJ)
Single 0.2 to ≤ 15
Energy output
Double 10 to ≤ 25
Triple 20 to ≤ 45
Energy adjustment Continuously variable across full energy range
1, 2, or 3 pulses each burst with the separation between pulses of
Burst mode
20 µs (nominal).

• Continuously variable from anterior -500 µm to posterior +500
YAG Offset Focus µm.
• 0, ± 150, 250, 500 µm
Pulse width 4 ns ± 2 ns
Repetition rate Up to 3 Hz
Item Air Breakdown (mJ)
Air breakdown In Air ≤ 2.5
In Liquid Solution ≤ 1.5
Spot size 8 µm
Cone angle 16°
Focal length 107 mm
Ocular safety filter OD5 at 1064 nm
Safety class Class IIIB
Energy display accuracy Better than ±20% of actual energy display
3.3 Aiming Laser Specifications

Item Description
Laser type Laser diode twin beam
Wavelength 635 nm (red)
Mode of operation Continuous wave (CW)
Output power Maximum of 200 µW
Power adjustment Continuously variable
Safety class Class I
3.4 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
3.5 Safety Filter Specifications

Item Description
Safety filter OD5 @ 1064 nm

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.
The Ophthalmic YAG Laser System is an ophthalmic laser suitable for performing the following
clinical procedures:
• Posterior capsulotomy
• Pupillary membranectomy
• Iridotomy
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 Ophthalmic YAG 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.
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 the Operator’s Manual for more clinical information.
This laser system console generates a controlled Nd:YAG (Neodymium-doped Yttrium Aluminum
Garnet) beam of 1064 nm wavelength light, which is in the near infrared spectrum and is invisible
to the human eye, that is focused into a small spot to be delivered via a slit lamp. The laser beam
is generated from the laser aperture and has a spot size of approximately 8 µm and its energy is
adjustable and selected by the user. Twin red aiming beams are used to position and focus the
treatment laser beam prior to delivering to the patient’s eye. The focused 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 4: YAG laser focusing for treatment.
The size of the plasma effect is directly proportional to the amount of energy in the focused 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 Ophthalmic YAG Laser System, the 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 treatment laser beam focus is adjustable by an offset dial
that is located on the left-hand side of the laser arm. This 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 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 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 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 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 the Operator’s
Manual for further information.
4.2 Laser System Operation

This system consists of two major parts, as described below:

• 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,
2 Slit lamp and 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.
i. The “LASER POWER” indicator lamp will illuminate.
ii. The display on the front panel of the slit lamp arm will turn ON and it will show the
following:
• Operation mode.
• Number of pulses.
• Total number of pulses and energy.
• Most recent energy setting.
iii. The system microprocessor controller will then perform internal self-tests to verify
that the machine is functioning properly.
iv. Should the system detect a fault at any time, it will automatically shut down to a
safe state and display an error code.
• Try rebooting the system to see if the error code can be resolved that way.
• 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.
• If the error code persists, contact the Manufacturer for service resolution.
v. 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 STANDBY mode
by default. This prevents any accidental firing of the treatment laser by disabling the fire
button and keeping the internal mechanical shutter, that is in the beam path, closed. The
system will also automatically be in single pulse mode by default.
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 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 pulse mode
or YAG energy is changed, the YAG laser will perform a test fire. It is
recommended to always start 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, 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.
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 5: YAG laser controls (front view).

Provides a manual immediate shutdown of the entire laser system in
the event of an emergency or irregular behavior of the laser system. It
Emergency stop
1 has a bright red button that locks down when pressed, where all power
button
is cut off from the internal components. To restore power to the
system, rotate the red button in the direction stated on the button label.
Rotating the key clockwise would turn the device ON. When the key
2 Key switch is in the ON position, it 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
“LASER
approximately a 7-second delay, allowing for laser emissions to be
4 POWER”
possible. Power is immediately removed when the button is pushed to
ON/OFF button
turn OFF. By default, 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
indicator laser electronics.
This button toggles the laser system between STANDBY and TREAT
“SET MODE” modes. In STANDBY mode, the laser cannot be fired by the joystick
6
button fire button and 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
STANDBY will be delivered. The laser can be tested with the “TEST” button (#9),
7
mode indicator however, the shutter 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
TREAT mode
8 the patient. All controls can be operated in this mode, including the
indicator
joystick fire button. If the laser system is not operated for 5 minutes,
the laser system will automatically toggle to STANDBY mode.
Pressing this button in either STANDBY or TREAT mode will fire the
“TEST” Fire laser but keep the shutter closed. This provides the user a safe way
9
button to check the 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
“SET PULSES” ON, only 1 (single) pulse mode is selected by default. When the pulse
10
button mode is changed, 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.
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
“PULSES” an amplifier, where the output is a series of pulses. The number of
11
display pulses sent from the laser corresponds to 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
“ENERGY” when the energy adjuster is changed. A photodiode is used to
12
display 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 the information as
the energy delivered from the laser in mJ. This display is 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
“TOTAL” register is displayed at all on the 2 displays. The total pulse and energy
13
displays displays will only increment 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 registers. This reset would be done between patients and
14 “RESET” button
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
15
button connected to the 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.
“ILLUMINATION
16 INTENSITY” This controls the brightness of the illumination lamp in the slit 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
knob intensity, there is still some illumination of the aiming beams.
The 2 control knobs, that work simultaneously, on either side of the
laser arm are used by the user to adjust the energy up or down. This
19 Energy adjuster 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, depending on the position of the controls,
which the control system reads and 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
energy, which is then displayed as well. The externally measured
Output energy must be within ±20% of the 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
“YAG OFFSET” general, these offset settings are used:
20
dial Offset Procedure
Posterior (+) Capsulotomy and membranectomy.
YAG laser beam is set to the same focus plane
Zero (0)
as the aiming beams and slit lamp illumination.
Anterior (-) Iridotomy.
4.3.2 Side View Controls
Figure 6: YAG laser controls (side view).

The joystick provides control over the horizontal and
1 Joystick arm vertical movements of the slit lamp. Rotating it adjusts the
vertical height.
Both eyepieces have ±8 diopter adjustments to the
2 Eyepiece diopters viewing focus. Always adjust focus from positive to
negative direction.
The viewing field can have different magnifications (5X,
3 Magnification adjuster
8X, 14X, 25X, 38X) set by rotating this adjuster.
When this collar is rotated, the illumination slit rotates
4 Slit rotation collar from 0° 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.
Controls the size of the illumination spot and the slit
6 Illumination aperture dial
height.
Controls the illumination filter: cobalt blue, red, green
7 Illumination filter dial
(red-free), heat-absorbing.
Indicates the ideal height for positioning the patient’s eye
8 Canthus mark in 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
9 Fixation lamp
to look at while being examined by the physician.
Can raise or lower the patient’s head in order to align their
10 Chinrest height adjuster
eye to the canthus mark on the chinrest post.
Locking screw for
11 Locks the illumination tower in place.
illumination tower
Locking screw for
12 Locks the laser head arm in place.
laser head arm
Locks the horizontal movement of the base. This should
always be locked when the laser system is not in use or
13 Locking screw for base
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. The target rod cannot be used to check the
14 Target rod
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.

Section 5 Installation
5.1 Introduction and Requirements

It is strongly recommended that the Ophthalmic YAG 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 YAG Service
Report (page 41) must be sent to the Manufacturer upon each installation completion. Both the
installer and customer are advised to keep a copy the LIGHTMED YAG 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 Ophthalmic YAG 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.

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 7 and 8 below:
Figure 7: Packing carton for the Ophthalmic YAG Laser System assembly.
Figure 8: Portable carrying case for Ophthalmic YAG Laser System.
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 7):
• The top layer contains the slit lamp and laser arm.
• The middle layer contains the chinrest and accessories kit.
• The bottom layer contains the control box and binoculars assembly.
The packing list is used to verify the items delivered. Please notify the Manufacturer is any
discrepancy is found.

The ophthalmic table and portable carrying case (Figure 8) 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.
Figure 9: Unpacking the accessories kit.

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 Ophthalmic YAG 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
5.5 Installation Process

The Ophthalmic YAG 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.
1. Place the control box on the tabletop.
2. Remove the slit lamp from its foam packaging. Equip the cross-slide shaft by removing
one of the gears, then slide the shaft through the bottom of the slit lamp (Figure 10). Refit
the gear that was removed.
Figure 10: Equipping the cross-slide shaft.

3. Carefully place the slit lamp on top of the control box with the 2 cables going in the right
direction and make sure the cables are not tangled or crisscrossed (Figure 11). Verify that
the cables are positioned correctly so that they do not rub the cable plates unnecessarily
when the slit lamp is moved horizontally. Verify that the slit lamp movement is smooth by
moving it to the maximum horizontal positions (front, back, left, and right).
Figure 11: The correct positioning of the 2 slit lamp cables.
4. Equip the 2 gear covers to secure the slit lamp to the control box and prevent the slit lamp
from sliding off the control box.
5. Attach the 3 connectors and 1 ground wire onto the back of the control box. Make sure
the connections and screw are tightly secured. The silver metal interlock connector should
already be attached to the back of the control box.

6. Connect the mains power cable to the back of the control box. Route the power cable as
shown in Figure 12.
Figure 12: Side view of the Ophthalmic YAG Laser System assembly.
Figure 13: Top view of the Ophthalmic YAG Laser System assembly.
7. Connect the fixation lamp cable that is attached to the chinrest to the back of the control
box (Figure 12). Install the chinrest and the back plate cover to the back of the control box
(Figure 11).

8. Equip the binoculars and eyepieces to the slit lamp.
9. The installation for the Ophthalmic YAG Laser System is complete (Figure 14).
Figure 14: Final assembly of the Ophthalmic YAG Laser System.
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. 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
5.6.2 Optical Alignment

For safety purposes, it is very important that the 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 15).
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
15).
Figure 15: Putting 2 red aiming beams together as one.
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 16). 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 16: YAG burn mark aligned to the merged aiming beams and illumination spot.
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.

LIGHTMED YAG 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
Product Name Laser S/N Product Type YAG
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: ________
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

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.
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.

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. 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
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. 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
12. YAG MODE BURNS (USER MODE)

Insert YAG mode burn picture(s) here:

13. COMPLETION CHECKLIST

PARAMETERS COMPLETED FAIL NOTES
1. Record Device User Settings
2. Installation Checklist
3. Optical Alignment
4. Verify Energy Displays
5. YAG 1064nm Energy Calibration ±20% Tolerance
6. Voltage Calibration
7. YAG Mode Burn
8. Return Device to Initial User Settings
INTERNAL USE ONLY

RMA Number Service Order Number
Reviewer Name Date Reviewed
Notes

Section 6 Clinical Use
The Ophthalmic YAG 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 laser power is required. Only the slit lamp will be
1 Slit lamp microscope
turned ON and used.
• Posterior capsulotomy.
Ophthalmic laser
2 • Pupillary membranectomy.
(explained below)
• Iridotomy.
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 Ophthalmic YAG Laser System 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.

6.1 Posterior Capsulotomy
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 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 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:

• 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 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.
Recommendations for posterior capsulotomy 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.
• 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:
i. Set the YAG offset to zero, then move the joystick forward until the
two spots separate by approximately one-spot diameter.
ii. 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.

iii. 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.
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

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 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
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 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 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.
• 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:

• 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.
• 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 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.
• 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.

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 back of the control box. Ensure
Mains Contact the Manufacturer or local
that the power cable is securely
1 electrical authorized Service Engineer for
plugged in to both the control box and
power assistance.
the mains power 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 • Replace the blown fuse. Spare
control box, as below: fuses are provided with each
laser system.
Mains Operation Fuse Rating at
(V) 250 V (A) • If the fuse is replaced, but the
2 power
fuses 100 – 120 TH3.15 system fails again, contact the
Manufacturer or local
200 – 230 TH2.5
authorized Service Engineer for
If the fuse blow, then it normally
assistance.
indicates a failure inside the system.
If the laser system cannot be
operated, then it means that the
control switches are not functioning. • Make sure that these
If there is a constant warning tone, connections are secured.
Remote
3 door
then it is probable that the bypass • Otherwise, contact the
connector on the back of the control Manufacturer or local
interlock
box or the switch/cable assembly to authorized Service Engineer for
the door interlock are not connected assistance.
properly, resulting in an open circuit
that is causing the problem.
• Verify that the mains power is
connected to the laser unit, the
key switch is in the ON position,
and the red emergency stop
Illumination
button is released.
4 LED Not illuminated.
module • If the LED module needs to be
replaced, contact the
assistance.

• 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
Fixation lamp cable is connected to the
5
lamp back of the control box.
• If the fixation lamp needs to be
replaced, contact the
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 9 for warranty details and
conditions.
A complete list of the error codes for Ophthalmic YAG 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

Shutter error. The shutter position is incorrect. It
Err 01 may be jammed open or shut. One of the shutter
sensors may be faulty.
Laser pulse circuit faulty. The circuit that detects
Err 02 laser pulses can measure the energy but no pulse
detection.
Laser cavity has over-pulsed. The laser cavity • Reboot the system.
Err 03
delivers more pulses than selected. • If the error code
Aiming beam module has failed. This may be a persists, contact the
Err 04
laser diode or circuit fault. Manufacturer or local
Memory or program error. The microprocessor authorized Service
Err 05
detects a memory or program problem. Engineer.
Err 06 Single pulse voltage is too high.
Err 07 Triple pulse voltage is too high.
Laser voltages have changed significantly since
Err 08
the last service. Service is due.
The energy circuit has failed. The energy from the
Err 09
laser cavity is below 0.1 mJ or no energy detected

by the microprocessor when the YAG laser is
fired, but there is still a laser pulse detected.
Joystick error. There may be a fault in the joystick
Err 10 fire switch circuitry. Ensure that the joystick is not
pressed upon system start-up.
Laser power supply unit (PSU) has failed. The
Err 11
PSU high voltage capacitor charge is not ready.
Memory or program error. Electronically erasable
Err 12 programmable read-only memory (EEPROM)
device fault.
10,000-shot increment since last service. Service
Usr 01
is due.
Laser cavity conditions have changed significantly
Usr 02
since the last service. Service is due.
Average laser cavity energy has deteriorated
Usr 03
significantly since the last service. Service is due.

Section 8 User Maintenance
The Ophthalmic YAG 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 Ophthalmic YAG 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 Ophthalmic YAG 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 9 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.

Section 9 Warranty Details and Conditions
The Manufacturer provides a limited warranty on the Ophthalmic YAG 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 Ophthalmic
YAG 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.

Section 10 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.
Emissions test Compliance Electromagnetic environment – guidance
The Ophthalmic YAG Laser, SeLecTor Deux
RF emissions uses RF energy only for its internal function.
Group 1 Therefore, its RF emissions are very low and
CISPR 11 are not likely to cause any interference in
nearby electronic equipment.
RF emissions
Class B
CISPR 11 The Ophthalmic YAG Laser, SeLecTor Deux
Harmonic emissions is suitable for use in all establishments,
Class A including domestic establishments and those
IEC 61000-3-2
directly connected to the public low-voltage
Voltage fluctuations/ power supply network that supplies buildings
flicker emissions Complies used for domestic purposes.
IEC 61000-3-3
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 output Separation distance according to frequency of transmitter
power of transmitter m
W
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz
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.

Guidance and manufacturer’s declaration – electromagnetic immunity
Immunity test IEC 60601 Compliance level Electromagnetic environment –
test level guidance
Electrostatic ±6 kV contact ±6 kV contact Floors should be wood, concrete or ceramic
discharge (ESD) ±8 kV air ±8 kV air tile. If floors are covered with synthetic
IEC 61000-4-2 material, the relative humidity should be at
least 30 %.
Electrical fast ±2 kV for power ±2 kV for power Mains power quality should be that of a
transient/burst supply lines supply lines typical commercial or hospital environment.
IEC 61000-4-4
±1 kV for input/output ±1 kV for input/output
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
IEC 61000-4-5 typical commercial or hospital environment.
±2 kV line(s) to earth ±2 kV line(s) to earth
interruptions and <5 % UT <5 % UT Mains power quality should be that of a
voltage variations typical commercial or hospital environment.
(>95 % dip in UT) (>95 % dip in UT)
on power supply If the user of the Ophthalmic YAG Laser,
input lines for 0,5 cycle for 0,5 cycle SeLecTor Deux requires continued
operation during power
IEC 61000-4-11 mains interruptions, it is recommended that
40 % UT 40 % UT
the Ophthalmic YAG Laser, SeLecTor Deux
(60 % dip in UT) (60 % dip in UT) be powered from an uninterruptible power
for 5 cycles for 5 cycles supply or a battery.
70 % UT 70 % UT
(30 % dip in UT) (30 % dip in UT)
for 25 cycles for 25 cycles
<5 % UT <5 % UT
(>95 % dip in UT) (>95 % dip in UT)
for 5 sec for 5 sec
Power frequency Power frequency magnetic fields should be
(50/60 Hz) at levels characteristic of a typical location
3 A/m 3 A/m
magnetic field in a typical commercial or hospital
IEC 61000-4-8 environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.

Guidance and manufacturer’s declaration – electromagnetic immunity
Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidance
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

d = 1,2
Conducted RF 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
3 Vrms
where P is the maximum output power rating of the

Radiated RF 3 V/m transmitter in watts (W) according to the transmitter
IEC 61000-4-3 80 MHz to 2,5 GHz manufacturer and d is the recommended separation
distance in metres (m).
3 V/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.

Appendix I Optional Accessories
The following accessories can be purchased from the Distributor to use with the Ophthalmic YAG
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 OD5 @ 1064 nm 620032
12 Slit lamp LED XLamp® XM-L2 2.85V 10W YL52C101
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

Appendix II Glossary
The abbreviations used in this Manual are as follows:
Abbreviation Description
ABD Air breakdown
AC Alternating current
AEL Accessible Emission Limits
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
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
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
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.
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.


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Operator's Manual

Ophthalmic YAG Laser System

Ophthalmic YAG Laser System

Ophthalmic YAG Laser System – Operator’s Manual Rev. No. 21 Page 2 of 67

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

Copyright © LIGHTMED Corporation

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

Document Number: YL0401

Document Revision History:

Draft 01 Aug. 1998 Draft prepared

Ophthalmic YAG Laser System – Operator’s Manual Rev. No. 21 Page 3 of 67

Ophthalmic YAG Laser System – Operator’s Manual Rev. No. 21 Page 4 of 67

Ophthalmic YAG Laser System – Operator’s Manual Rev. No. 21 Page 5 of 67

Ophthalmic YAG Laser System – Operator’s Manual Rev. No. 21 Page 6 of 67

Ophthalmic YAG Laser System – Operator’s Manual Rev. No. 21 Page 7 of 67

Ophthalmic YAG Laser System – Operator’s Manual Rev. No. 21 Page 8 of 67

2.1 Product Classifications

Ophthalmic YAG Laser System – Operator’s Manual Rev. No. 21 Page 9 of 67

2.3 Optical Hazards

Ophthalmic YAG Laser System – Operator’s Manual Rev. No. 21 Page 10 of 67

2.3.1 Nominal Ocular Hazard Distance (NOHD)

The calculated NOHD for the Ophthalmic YAG Laser is as follows:

Pulse NOHD (m)

2.3.2 Avoid Exposure to Laser Beams

2.4 Electrical Hazards

Ophthalmic YAG Laser System – Operator’s Manual Rev. No. 21 Page 11 of 67

2.5 Safety Controls and Features

Figure 1: Safety controls and features.

No. Item Description

Ophthalmic YAG Laser System – Operator’s Manual Rev. No. 21 Page 12 of 67

Ophthalmic YAG Laser System – Operator’s Manual Rev. No. 21 Page 13 of 67

Ophthalmic YAG Laser System – Operator’s Manual Rev. No. 21 Page 14 of 67

2.6.1 Control Box Labels

Figure 2: Control box safety labels.

Ophthalmic YAG Laser System – Operator’s Manual Rev. No. 21 Page 15 of 67

Laser danger sign.

Laser information label.

Indicates the medical device Manufacturer, as

Indicates the authorized representative in the

Indicates the medical device’s manufactured

This product requires a 100-volt current.

Ophthalmic YAG Laser System – Operator’s Manual Rev. No. 21 Page 16 of 67

Caution. Indicates the need for the user to

2.6.2 Slit Lamp Labels

Figure 3: Slit lamp labels.

Indicates the medical device’s model and serial

Ophthalmic YAG Laser System – Operator’s Manual Rev. No. 21 Page 17 of 67

3.1 General Specifications

3.2 Treatment Laser Specifications

Ophthalmic YAG Laser System – Operator’s Manual Rev. No. 21 Page 18 of 67

3.3 Aiming Laser Specifications

3.4 Slit Lamp Specifications

Ophthalmic YAG Laser System – Operator’s Manual Rev. No. 21 Page 19 of 67

3.5 Safety Filter Specifications

Ophthalmic YAG Laser System – Operator’s Manual Rev. No. 21 Page 20 of 67

4.1 General Description

Ophthalmic YAG Laser System – Operator’s Manual Rev. No. 21 Page 21 of 67

Figure 4: YAG laser focusing for treatment.