Operators Manual
LightLas 532
   Green Laser Photocoagulator With LCD
               Control Panel
LightLas532  Operators Manual   Rev. No 01   Page 1of 115
                  Operators Manual
                                   for the
                               LightLas 532
   Green Laser Photocoagulator With LCD
               Control Panel
                                                      Directive 93/42/EEC
                                                as amended by 2007/47/EC
                                                       Doc. No. : DC1001
                                                             Rev. No. : 01
LightLas 532  Operator's Manual   Rev. No 01                  Page 2 of 115
      Operators Manual for the LightLas 532 Green Laser
                     Photocoagulator
Clinicians or Doctors should ensure that they are adequately knowledge of the
operation procedures prior to using the LightLas 532 Laser system.
This Operators Manual should be studied and understood before proceeding to
operate the equipment on patients.
CAUTIONS - Use of controls or adjustments or performance of procedures other
          than those specified herein may result in hazardous radiation exposure.
CAUTIONS - Any modification to the Ophthalmic Laser will result in the necessity for
           it to be reclassified
CAUTIONS - U.S. law restricts this device to sell by or on the order of a physician
This Operators Manual contains confidential and proprietary information of the
Manufacturer.
Manufactured by: LightMed Corporation, No.1-1, Ln. 1, Pao-An St. Sec. 3,Shulin Dist.,
                 New Taipei City 23861, Taiwan
USA Address:             1030 Calle Cordillera, Suite 101, San Clemente, CA 92673
                         Tel No.: 949-218-9555 Fax No.: 949-218-9556
Copyright  LightMed Corporation
EU Representative:                 Medical Device Safety Service GmbH
                                   Schiffgraben 41, 30175 Hannover, Germany
Document Title:                           Operators Manual for the LightLas 532 Ophthalmic Laser
Document Number:                          DC1001
Document Revision History:
DRAFT                March 2014           Draft prepared
 01                  August               Release 01 version
LightLas 532  Operator's Manual              Rev. No 01                           Page 3 of 115
                                   Table of Contents
Section 1               INTRODUCTION .................................................................................. 9
Section 2               SAFETY ............................................................................................. 10
                        2.1 Product Classifications ............................................................... 10
                        2.2 Warnings and Precautions ......................................................... 11
                        2.3 Optical Hazards ......................................................................... 12
                            2.3.1 Nominal Ocular Hazard Distance (NOHD) ........................... 12
                            2.3.2 Avoid Exposure to Laser beams .......................................... 13
                        2.4 Electrical Hazards ...................................................................... 13
                        2.5 Safety Controls and Features ..................................................... 14
                        2.6 Product Labeling ........................................................................ 14
                           2.6.1 Console system .................................................................. 14
                           2.6.2 Integrated Slitlamp LDU.................................................... 16
                           2.6.3 Laser Indirect Ophthalmoscope LDU ................................... 18
                           2.6.4 Attachment LDU ................................................................ 19
                           2.6.5 Safety Filter (Manually) ..................................................... 20
Section 3                PRODUCT SPECIFICATIONS............................................................... 21
                        3.1 LightLas 532 System Specification ............................................. 21
                        3.2 CSO SL980 and SL990 Slitlamp Specifications ............................. 24
Section 4               PRINCIPLES OF OPERATION .............................................................. 25
                        4.1 General Description ................................................................... 25
                        4.2 LightLas 532 Laser Controls and Displays ................................... 33
                            4.2.1 Laser Console .................................................................... 33
                            4.2.2 Slitlamp Delivery Unit ....................................................... 40
                            4.2.3 Laser Indirect Ophthalmoscope (LIO) ................................. 44
                            4.2.4 Two types of Integrated CSO SL980 and SL990
                                  Slitlamp Controls Breakdown ............................................ 47
Section 5               INSTALLATION .................................................................................. 51
                        5.1 Introduction and Requirements ................................................. 51
                        5.2 Unpacking and Receiving Inspection .......................................... 52
                        5.3 Tools and Equipment ................................................................. 54
                        5.4 Setting Up the Laser System Parts .............................................. 55
                            5.4.1 Slitlamp Integrated LDU.................................................... 56
                            5.4.2 Laser Indirect Ophthalmoscope LDU (LIO).......................... 68
                            5.4.3 Endoprobes LDU ............................................................... 69
                        5.5 Pre-check / Alignment Procedures ............................................. 72
                            5.5.1 Pre-check Laser console operation .................................... 72
                            5.5.2 Pre-check / Alignment LDU ............................................... 74
LightLas 532  Operator's Manual                  Rev. No 01                                           Page 4 of 115
Section 6              CLINICAL USE .................................................................................... 87
                       6.1 Different types of LDUs Indication / Contraindication Use....88
                           6.1.1 Slitlamp Delivery Unit ........................................................ 88
                           6.1.2 Laser Indirect Ophthalmoscope (LIO).................................. 88
                           6.1.3 Endoprobe devices ............................................................. 89
                       6.2 General Warnings...................................................................... 90
                       6.3 Possible side-effect or adverse reactions .................................... 92
Section 7              MAINTENANCE ................................................................................. 93
                       7.1 Operator / User Maintenance ..................................................... 93
                       7.2 Laser Beam Alignment Check ...................................................... 94
                       7.3 System Output Power Checking Procedure ................................. 95
Section 8             TROUBLESHOOTING .......................................................................... 97
                       8.1 Symptom / Warning ................................................................... 97
                       8.2 Warning ..................................................................................... 99
                       8.3 Error Codes ............................................................................... 102
Section 9             European Community Issues ............................................................. 106
Section 10            EMC Test Tables ............................................................................... 108
LightLas 532  Operator's Manual                 Rev. No 01                                         Page 5 of 115
                   LIST OF DRAWINGS / FIGURES
 Figure      Description                                                                    Page
 2.1         Laser Console Safety and Controls Labels                                        14
 2.2         Laser Console Safety labels                                                     15
 2.3(a)      Integrated Slitlamp LDU with Labels (RH side)                                   16
 2.3(b)      Integrated Slitlamp LDU with Labels (LH side)                                   17
 2.4         LIO LDU with Labels                                                             18
 2.5         Attachment LDU with Labels                                                      19
 2.6         Microscope Doctor Safety Filter with Labels                                     19
 2.7         Microscope Safety Filter with labels                                            20
 4.1         System software start up screen shot                                            29
 4.2         System software boot up ok and system is "Standby" mode                         29
 4.3         System software is ready to shutdown                                            32
 4.4         Laser Console Controls and LCD Displays                                         33
 4.5         LCD Panel Displays and Control                                                  34
 4.6         Integrated Slitlamp LDU Controls                                                40
 4.7(a)      Attachment Slitlamp LDU Controls                                                41
 4.7(b)      Truspot Attachment Slitlamp LDU Controls (New version)                          41
 4.8(a)      Front View of LIO LDU Controls                                                  44
 4.8(b)      Top View of LIO LDU Controls                                                    44
 4.9         SL980 Slitlamp Parts List and Controls                                         47/48
 4.10        SL990 Slitlamp Parts List and Controls                                         49/50
 5.1         Packing Carton for Integrated LDU and Slitlamp                                  52
 5.2         Portable Carry Cases for Console and LDUs                                      53
 5.3         Laser System Parts                                                              55
 5.4         Slitlamp table top ass'y                                                        57
 5.5(a)      Rear view box connection                                                        57
 5.5(b)      Removal fuse socket                                                             58
 5.5(c)      Removal fuses                                                                   58
 5.5(d)      Removal voltage setting block and reinsert it back upon completion              59
 5.6         Slitlamp Assy                                                                  59
 5.7         Assembled Upper and Lower Housing Screw                                         60
 5.8         Slitlamp mounted onto Table Top ready for Integrated LDU                        60
 5.9         Slitlamp arm ready for Delivery housing                                         61
 5.10        Fit Delivery unit housing to the Slitlamp                                       62
             Lock the housing securely to the Slitlamp when it is pushed against
 5.11                                                                                        62
             Chrome Stop screw
LightLas 532  Operator's Manual        Rev. No 01                          Page 6 of 115
 Figure      Description                                                                        Page
 5.12        Align the keyways then fit the Zoom unit to the Delivery housing                    63
 5.13        Rotate the Zoom housing to the end stop                                             63
 5.14(a)     Original Illumination Tower                                                         64
 5.14(b)     New modified Illumination Tower fitted                                              64
 5.15(a)     Haag Streit Attaching Tonometer mount ready for Attachment LDU                      65
             Zeiss 30SL Attaching the Tonometer mount and Attachment LDU
 5.15(b)                                                                                         65
             Mounting Arm
             Lightmed SYL9000 Attaching Tonometer mount ready for Attachment
 5.15(c1)                                                                                        66
             LDU
             Lightmed SYL9000 Attaching the Tonometer mount and Attachment
 5.15(c2)                                                                                        66
             LDU Mounting Arm
             Haag Streit Mounting the whole attachment LDU to Tonometer mount
 5.16(a)                                                                                         67
             & micromanipulator
             Zeiss Style 30SL Mounting the whole attachment LDU to Tonometer
 5.16(b)                                                                                         67
             mount & micromanipulator
             Lightmed SYL9000 Mounting the whole attachment LDU to Tonometer
 5.16(c)                                                                                         67
             mount & micromanipulator
 5.17        Fiber tips cleaning                                                                 68
 5.18        LIO connections in console                                                          68
 5.19        LIO LDU fiber connection                                                            68
 5.20        Endoprobe plug installation                                                         69
 5.21(a)     Standard System connection set-up                                                   71
 5.21(b)     Combo System Y-Joint connection set-up                                              71
 5.21(c)     Sample of Delivery Fiber and Delivery Key Connection                                71
 5.22(a)     System boot up sequential display #1                                                72
 5.22(b)     System boot up sequential display #2                                                72
 5.22(c)     Initial Power on displays and outputs                                               72
 5.22(d)     Sample of Delivery Fiber and Delivery Key Connection                                72
 5.23        Safety filter checks                                                                73
 5.24        Attach the Delivery fiber to the Zoom unit                                          73
 5.25        Upper / Lower Slit Alignment Aiming Integrity and Focus Checkout                    75
 5.26        Realignment set screw location (X-Y axis)                                           76
LightLas 532  Operator's Manual           Rev. No 01                           Page 7 of 115
 Figure      Description                                                                    Page
 5.27(a)     Checking Field of View set-up                                                   76
 5.27(b)     Checking manipulator operation on the target                                    76
             New Type Version Check Slitlamp focus on Target Rod and Laser focus
 5.28(a)                                                                                     79
             of aiming beam
             Old type Version Adjust the Attachment LDU Spot Size Focus using the
 5.28(b)                                                                                     80
             knob on the mounting arm
             Old type version Adjusting Micromanipulator Arm to verify Laser Spot is
 5.29                                                                                        80
             in the Aperture Center
             Old / New type version Adjusting sideways movement of Attachment
 5.30                                                                                        81
             LDU during alignment
 5.31(a)     Fiber and Delivery Key fitted to Console Front Panel                            82
 5.31(b)     LIO Intensity Control Knob                                                      83
 8.1         Sample of Error code display                                                   102
                                      Record Sheet
             Installation Record Sheet                                              84/85/86
             Power Meter Calibration Record Sheet                                       96
                                         Appendix I
             All the Accessories Listing Detailed                                      113/114
LightLas 532  Operator's Manual          Rev. No 01                        Page 8 of 115
Section 1                      INTRODUCTION
This manual is intended to provide the operator with an overview of the operation
and safety requirements for the LightLas 532 Ophthalmic Laser. This manual is not
intended to provide instructions on actual treatment procedures and it is expected
that users will have undertaken training prior to using the equipment.
The Manufacturer and Distribution organization assume no liability through the use
of this Laser system.
All care has been taken in the preparation and checking of this manual however there
is no guarantee provided that all information is correct. The information provided in
this manual is subject to change without notice.
Only approved or authorized accessories may be used in the LightLas 532. The
Manufacturer and Distribution organization shall not be held liable or responsible for
damages or injury caused as a result of using non-approved accessories. This includes
all Optical Fiber systems, Laser Delivery Units, Safety Filters, Safety Glasses and Table
units.
All maintenance and service work must be carried out by authorized and trained
service agents and only those procedures outlined in the operator 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 supplied for the LightLas 532. If
you require technical documentation that is not provided in this manual then please
contact the manufacturer or your local distributor in writing with your reasons for
wanting them and then a copy of the service manual may be provided.
Before using the LightLas 532 Photocoagulator Laser system the operator should
read this manual carefully and pay particular attention to the sections of Safety,
Operation and Maintenance.
LightLas 532  Operator's Manual      Rev. No 01                           Page 9 of 115
Section 2                      SAFETY
This Laser system has been designed and tested to function in a safe and correct
when used as indicated in this manual.
Do not use this laser before reading and understanding completely this Operators
Manual.
It is important to remember that this laser emits high levels of visible laser radiation
which can cause permanent and irreparable eye and tissue damage. 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 LightLas 532 Photocoagulator Laser is a Class IV laser product as specified in the
standard IEC60825-1 (2007) and the USA 21 CFRs 1040.10, 1040.11.
The LightLas 532 Photocoagulator Laser is classified as Class I Type B Electromedical
equipment as specified in the IEC60601-1 standard.
The LightLas 532 Photocoagulator Laser is classified as a Class II device according to
the FDA CFR21 regulations.
The LightLas 532 Photocoagulator Laser is classified as a Class II Type B Medical
Device according to the MDD 93/42/EEC (as amended by 2007/47/EC).
The LightLas 532 has been designed to comply with the following standards:
       Laser standards
              IEC 60825-1 (2007)
              USA 21 CFR 1040.10, 1040.11 (1997)
              IEC60601-2-22 (1995)
         Electrical standards
             IEC 60601-1:2005
             EN 60601-1:2006
             EN 60601-1-2:2007
             IEC60601-1-2 :2007
             USA UL 2601
             JIS T1001 (1992) and T1002 (1992)
         Others
               MDD 93/42/EEC (as amended by 2007/47/EC)
               EN 60601-1-6:2010
               IEC 60601-1-6 :2010
LightLas 532  Operator's Manual       Rev. No 01                         Page 10 of 115
               EN62366 :2008
               IEC62366 :2007
               EN 980:2008
               ISO14971 (2012)
2.2       Warnings and Precautions
The following warnings and precautions apply to the LightLas 532 Laser System and
should be observed by all users at all time:
         DO NOT look directly into the laser beam or at 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. The protective eyewear must have an optical density of OD4 or
          more at 532 nanometers wavelength. This information must be present 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 an authorized and trained
          agent of the manufacturer.
         DO NOT fire the laser on a patient without first checking the operation of the
          laser and verifying the optical alignment of the treatment Laser beam.
         ALWAYS use the lowest power settings possible when treating a patient
          with the laser and start the treatment with minimum level of power.
         ALWAYS set the correct spot size and/or use the most appropriate one for
          the power setting and type of procedure that is 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 an extreme measured precaution, such as wearing
          surgical masks or use plume evacuation systems when a treatment is
          undergoing. Caution - Laser plume may contain viable tissue particulates.
         ALWAYS take particular care of the optical fibers that connect the Laser
          Delivery Units to the Console to make sure they do not get damaged.
LightLas 532  Operator's Manual       Rev. No 01                         Page 11 of 115
          Additional clinical warnings may be found in Section 6.1.4 of this Manual.
         ALWAYS try to let the laser have its own or 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 Console if the ambient temperature is outside the
          range of 20 to 35C. This temperature range is the rated operating
          temperature limits where the Laser system can be guaranteed to operate
          without any interruptions to normal use. Outside this range of temperature
          it is possible that the Laser will generate an error condition where the word
          hold is displayed and the system goes to Standby until the internal
          temperature returns to within normal limits then the Laser can be used again
          but the error condition may reoccur unless the rated temperature comes
          within limits.
2.3       Optical Hazards
Guidance for the safe use of Lasers and Laser systems is found in the standard
IEC60825-1, the USA 21CFR 1040.10, 1040.11 and ANSI Z136.1 - 1986.
During normal operation of the LightLas 532 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 4 and the
wavelength 532nm range is also specified on it. It is shown in the following format:
          OD4+ @ 532nm
Otherwise, the safety glasses are NOT suitable for this purpose of eye protection.
Safety Glasses are required to have the CE mark applied if used in the EU.
The LightLas 532 uses a Class II Laser Diode Aiming beam. Its wavelength range from
635 to 650 nanometers (nm) and the maximum power output is set at the factory to
be less than 1mW delivered to the patients cornea. However it is always
recommended to use the lowest aiming beam intensity during treatments.
The LightLas 532 Photocoagulator Laser has been classified as a Class 4 and its
classification specified accordingly to the above quoted standards. This classification
is also based on the Accessible Emission Limits (AEL) as calculated according to the
standards.
2.3.1 Nominal Ocular Hazard Distance (NOHD)
The Nominal Ocular Hazard Distance (NOHD) is the distance between the equipment
LightLas 532  Operator's Manual       Rev. No 01                          Page 12 of 115
and a persons eye for which the optical power, from the equipment, entering the
dilated pupil of the person will be less than or equal to the Maximum Permissible
Exposure (MPE) as specified in the standards (i.e. less than a Class 1 Laser Output).
The calculated NOHD for the LightLas 532 with different Laser Delivery Units is:
     5 meters at maximum power settings for the Endoprobes
     18 meters at maximum power settings and 1000m spot size for Slitlamp Delivery
      Units
     20 meters at maximum power settings for LIO
Therefore when the laser is in operation, all persons that are closer than these
distances to the equipment should be wearing eye protection.
Patients, where possible, 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 you or standby observers could be exposed to
dangerous levels of laser radiation and potentially lethal electrical voltages.
Eye safety filters are designed to protect physicians eyes from back scattered laser
beams must always be used. They are integrated into the Slitlamp and LIO Delivery
Units. When using the endoprobes a separate filter that attaches to the operating
microscope must be used.
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. This means avoid looking into the aperture of
any of the laser delivery units or the console.
2.4      Electrical Hazards
The Lightlas 532 Photocoagulator laser has been designed to apply the International
Standards for Medical Equipment. The laser system is designed to operate with three
terminal prongs AC voltage where the third prong pin is the earth-grounded prong.
Warning: It is not safe to operate the Lightlas 532 photocoagulator laser without an
earth-grounded receptacle. There is possible risk of electric shock.
No cover or housing need to be removed by the operator or user. Only the
authorized and trained service or agent can remove the cover or housing assembly
LightLas 532  Operator's Manual      Rev. No 01                          Page 13 of 115
since there is possible of exposing laser radiation and high current or voltages.
2.5 Product Labeling
All the labels on the LightLas 532 comply with the requirements of the various
regulatory standards referred to previously.
2.5.1 Console system
A full facsimile of all the safety and control labels is shown in the figures 2.1 and 2.2.
                                                                                                                                                                                                                      LIGHTMED
                                                                                                                                                                                                            LIO
                                                                                                                                                       LIO                                   Delivery
                                                                                                                                                                                              Key
                                                                                                                                                                                                                                                    STOP
                                                                                                                                                                                                                                                           STOP
             INPUT: 100-230V ~ (Fuse:T3.15AH250V)
                    50/60Hz, 400VA                  DANGER!                                          DANGER!
                                                    Do not remove covers. Shock hazard and           Ne pas ouvrir L'appareil risque de chocs electriques                   Danger/Caution
                                                    accessible laser radiation. Refer servicing to   exposition dangereuse au rayonnement                      Visible and Invisible laser radiation when open
                                                    qualified service personnel.                     Laser direct ou diffuse reparations par service            AVOID EYE OR SKIN EXPOSURE TO
                                                    Risk of explosion if used in the presence of     technique qualifie.                                        DIRECT OR SCATTERED RADIATION
                                                    flammable anesthetics.                           Risques d'explosion si utilise en presence
                                                                                                     d'anesthesiques inflammables
                                                    ACHTUNG!
                                                    GEHAUSETEILE NICHT ENTFERNEN                     For grounding reliability
                                                    Gefahr eines elektrischen Schlages               connect only to with a "Hospital
                                                    Laserstrahlung zuganglich.                       Grade receptacle".
                                                    Wartungsarbeiten nur durch qualifizierten        Complies to the requirements of
                                                    Kundendienst.                                    21CFR, Chapter 1, Subchapter J
                                                    EXPLOSIONSGEFAHR
                                                    Dieses Gerat ist nicht fur den Betrieb in
                  AC MAINS INPUT                    explosiongefahrdeten bereichen bestimmt
                                                                                                                                           FOOTSWITCH                  DOOR
                                                                                                                                                                    INTERLOCK
                     WARNING
                       Risk of fire
                   Replace only with
                 fuse as marked above
                                                                                                                                                                                                                                                                            LASER RADIATION
                                                                                                                                                                                                                                                                     AVOID EYE OR SKIN EXPOSURE TO
                                                                                                                                                                                                                                                                     DIRECT OR SCATTERED RADIATION
                                                                                                                                                                                                                           LASER RADIATION                               CLASS 4 LASER PRODUCT
                                                                                                                                                                                                                    AVOID EYE OR SKIN EXPOSURE TO
                                                                                                                                                                                                                    DIRECT OR SCATTERED RADIATION
                                                                                                                                                                                                                        CLASS 4 LASER PRODUCT                          Green Laser 532nm 2.0W CW Max
                                                                                                                                                                                                                      Green Laser 532nm 2.0W CW Max               Diode Aiming Laser 635-650nm 1mW CW Max
                                                                                                                                                                                                                 Diode Aiming Laser 635-650nm 1mW CW Max
                                                                                          Figure 2.1
                                                                           Laser Console Safety and Control Labels
LightLas 532  Operator's Manual                                                                                                                             Rev. No 01                                                                                                              Page 14 of 115
2.5.1 Console system continues...
                                                                                                                                                                           Manufactured by LightMed Corporation
                 MANUFACTURED:
                                                                                                                                                                          No1-1, Lane 1, Pao-An Street, Section 3
                                                                                                                                                                             Shulin City, Taipei 238, TAIWAN
                                                                                                  EC REP      EU Authorized Representative
                                                                                                (MDD 93/42/EEC as amended by 2007/47/EC)
                                                                                                    Medical Device Safety Service GmbH
                                                                                                 Schiffgraben 41, 30175 Hannover, Germany
                                                                                                                                                               Lightmed Corporation
                            Lightmed Corporation
                                                                                                                                                          MODEL NO:
                          MODEL NO:
                          SERIAL NO:                                                                                                                      SERIAL NO:
                                       Coiling
                                                 "Instructions Under Lid"
                                                                                                                                                                                                                                          Lightmed Corporation
                                                                                                                                                                                                                                        MODEL NO:
                                                                                                                                                                                                                                        SERIAL NO:
           INPUT: 100-230V ~ (Fuse:T3.15AH250V)
                  50/60Hz, 400VA                                  DANGER!                                          DANGER!
                                                                  Do not remove covers. Shock hazard and           Ne pas ouvrir L'appareil risque de chocs electriques                            Danger/Caution
                                                                  accessible laser radiation. Refer servicing to   exposition dangereuse au rayonnement                               Visible and Invisible laser radiation when open
                                                                  qualified service personnel.                     Laser direct ou diffuse reparations par service                     AVOID EYE OR SKIN EXPOSURE TO
                                                                  Risk of explosion if used in the presence of     technique qualifie.                                                 DIRECT OR SCATTERED RADIATION
                                                                  flammable anesthetics.                           Risques d'explosion si utilise en presence
                                                                                                                   d'anesthesiques inflammables
                                                                  ACHTUNG!
                                                                  GEHAUSETEILE NICHT ENTFERNEN                     For grounding reliability
                                                                  Gefahr eines elektrischen Schlages               connect only to with a "Hospital
                                                                  Laserstrahlung zuganglich.                       Grade receptacle".
                                                                  Wartungsarbeiten nur durch qualifizierten        Complies to the requirements of
                                                                  Kundendienst.                                    21CFR, Chapter 1, Subchapter J
                                                                  EXPLOSIONSGEFAHR
                                                                  Dieses Gerat ist nicht fur den Betrieb in
                AC MAINS INPUT                                    explosiongefahrdeten bereichen bestimmt
                                                                                                                                                         FOOTSWITCH                           DOOR
                                                                                                                                                                                           INTERLOCK
                   WARNING
                     Risk of fire
                 Replace only with
               fuse as marked above
                                                                                                            Figure 2.2
                                                                                                    Laser Console Safety Labels
LightLas 532  Operator's Manual                                                                                                        Rev. No 01                                                                                      Page 15 of 115
2.5.2 Integrated Slitlamp LDU
                                                                VISIBLE LASER RADIATION
                                                             AVOID EYE OR SKIN EXPOSURE
                                                                TO DIRECT OR SCATTERED
                                                                       RADIATION
                                                       CLASS 4 LASER PRODUCT IEC/EN 60825-1:2007
               CAUTION/DANGER
                 VISIBLE LASER RADIATION
               AVOID EYE OR SKIN EXPOSURE
                 TO DIRECT OR SCATTERED
                        RADIATION
        CLASS 4 LASER PRODUCT IEC/EN 60825-1:2007
                                                                Figure 2.3(a)
                                               Integrated Slitlamp LDU with labels (RH side)
LightLas 532  Operator's Manual                                                                   Rev. No 01   Page 16 of 115
2.5.2 Integrated Slitlamp LDU continues...
                                                              DANGER / CAUTION
                                                          Visible laser radiation when open
                                                       AVOID EYE OR SKIN EXPOSURE TO
                                                       DIRECT OR SCATTERED RADIATION
                                                                                                                           0434
                                                                                              Lightmed Corporation
                                                                                              Safety Filter Model No:
                                                                                              OD4@532nm Serial No:
                                                                                                        DANGER / CAUTION
                                                                                                    Visible laser radiation when open
                                                                                                 AVOID EYE OR SKIN EXPOSURE TO
                                                                                                 DIRECT OR SCATTERED RADIATION
                                          Figure 2.3(b)
                         Integrated Slitlamp LDU with labels (LH side)
LightLas 532  Operator's Manual          Rev. No 01                                                                       Page 17 of 115
2.5.3 Laser Indirect Ophthalmoscope LDU
                                   Figure 2.4 LIO LDU with labels
LightLas 532  Operator's Manual            Rev. No 01              Page 18 of 115
2.5.4 Attachment LDU
                                                                                                                                                                              Lightmed Corporation
                                                                                                                                                                              Safety Filter OD4@532nm
                                                                                                                                                                              Model No:
                                                                                                                                                                              Serial No:
                                                                                                                                                                               Manufactured:
                                                                                                      Lightmed Corporation
                                                                                                      Safety Filter OD4@532nm
                                                                                                      Model No:
                                                                                                      Serial No:
                                                                                                        Manufactured:
                                              CAUTION/DANGER
                                                VISIBLE LASER RADIATION                                DANGER / CAUTION
                                             AVOID EYE OR SKIN EXPOSURE                            Visible laser radiation when open
                                                                                                AVOID EYE OR SKIN EXPOSURE TO
                                                TO DIRECT OR SCATTERED                          DIRECT OR SCATTERED RADIATION
                                                       RADIATION
                                       CLASS 4 LASER PRODUCT IEC/EN 60825-1:2007
                                                                    Figure 2.5
                                                             Attachment LDU with labels
                                        Lightmed Corporation
                                         Safety Filter OD4@532nm                                                                                  500                                300 400 500
                                         Model No:
                                         Serial No:
                                           Manufactured:
             Lightmed Corporation
             Safety Filter OD4@577nm
             Model No:
             Serial No:
              Manufactured:
                                                                                                                                             CAUTION/DANGER
                                                                                                                                             VISIBLE LASER RADIATION
                                                                                                                                           AVOID EYE OR SKIN EXPOSURE
                                                                                                                                             TO DIRECT OR SCATTERED
                                                                                                                                                    RADIATION
                                                                                                                                       CLASS 4 LASER PRODUCT IEC825-1(1993)
                                                                                                                                                                                           CAUTION/DANGER
                                                                                                                                                                                          VISIBLE LASER RADIATION
                                                                                                                                                                                       AVOID EYE OR SKIN EXPOSURE
                                                                                                                                                                                         TO DIRECT OR SCATTERED
                                                                                                                                                                                                 RADIATION
                                                                                                                                                                                   CLASS 4 LASER PRODUCT IEC60825-1 2007
                                                                 Figure 2.6
                                                      TruSpot Attachment LDU Labeling
LightLas 532  Operator's Manual                                                   Rev. No 01                                                                                                              Page 19 of 115
2.5.5 Safety Filter (Manually)
                                                                                                           OD4@532nm Serial No:
                                                                                                           Safety Filter
                                                                                                           Lightmed Corporation
             Manufactured:
                                                                                                                         Model No:
                                                                                                                                     FIL
                                                                           Lightmed Corporation                                            FILTER
                             Manufactured:                                 Safety Filter Model No:
                                                                           OD4@532nm Serial No:
                                                    Figure 2.7
                                        Microscope Safety Filter with labels
LightLas 532  Operator's Manual                    Rev. No 01                                       Page 20 of 115
Section 3                 PRODUCT SPECIFICATIONS
3.1    LightLas 532 System Specification
The following are the System Specifications for the LightLas 532 Ophthalmic Laser.
_____________________________________________________________________
Console Laser System
General Specification
    Electrical Input                   :   100 to 230 Vac. 50/60 Hz Single phase
    Power                              :   400W
    Fuse rating                        :   T3.15AH250V @ 100-230Vac (Time Lag)
    Temperature Range                  :   Transport: -10 to 70C
                                           Operating: 15 to 30C
                                           Storage: -10 to 55C
      Relative Humidity Range :            Operating: 30% - 85% non-condensing
                                           Storage and Transport: up to 95% non-condensing
      Atmospheric pressure             :   Operating: 800-1060 mbar
                                           Storage and Transport: 500-1060 mbar
      Cooling System                   :   Fan cooled and TECs for Laser Diode and Crystal
      Dimensions (Total)               :   130mm(H) x 370mm(W) x 330mm(D)
      Weight                           :   13 Kg (System) 20 Kg (Packed)
Treatment Laser
    Laser Type                     :   Diode Pumped Frequency Doubled YAG
    Wavelength                     :   532 nm
    Mode of Operation              :   CW
    Power Output                   :   2 W Maximum
    Power Adjustment               :   Variable from 0.05 to 2.0 W
    Exposure Duration              :   0.01, 0.02, 0.03, 0.04, 0.05, 0.06, 0.08, 0.1, 0.15 and
                                       0.2 to 3.0s is 0.1s increment
      Repeat Interval              :   Selectable from 0.01 to 3.0 secs and equal to or greater
                                       than exposure duration in same discrete steps as
                                       duration
      SP Mode                      :   Duty cycle selections - 7.5%, 150s On time
                                                               - 10%, 200s On time
                                                               - 12.5%, 250s On time
                                                               - 15%, 300s On time
                                                               - 17.5% ,350s On time
                                                               - 20%, 400s On time
LightLas 532  Operator's Manual              Rev. No 01                          Page 21 of 115
    Doctor Safety Filter :  OD4 at 532 nm
    Safety Class         :  Class 4
    Power Display accuracy: Better than +/-20% of actual
    Beam Divergence : < 0.2 NA
____________________________________________________________________
Aiming Laser
    Laser Type           :  Red Laser Diode
    Wavelength           :  635650 nm (Red)
    Mode of operation :     Continuous Wave (CW)
    Output power         :  Maximum of 1.0mW
    Power adjustment :      Continuously variable
    Safety Class         :  Class 2
___________________________________________________________________
Laser Delivery Units (LDU)
Integrated Slitlamp LDU
     Slitlamp model     :              CSO Model SL980 (Detailed refer to p.32)
     Spot Sizes         :              50, 100, 200, 300, 400, 500, 1000 m selectable
                                       on Zoom assembly of Delivery unit
      Focus plane                  :    All spot sizes Parfocal to Slitlamp focus plane
      Fiber Length                 :   2m
      Mounting                     :   Direct to Slitlamp housing
      Safety Filter                :   Fixed filter OD 4 @ 532nm
      Beam Divergence              :   Cone angle of 20
Attachment Slitlamp LDU
    Slitlamp model     :    To attach on CSO Model SL990 (Detailed refer to p.32),
                            Haag Streit models BM or BQ, most Haag Streit Clone
                            Slitlamps and Zeiss SL30
    Spot Sizes         :    50, 125, 200, 300, 500m selectable on housing of
                            Delivery unit
    Focus plane        :    All spot sizes Parfocal to Slitlamp focus plane
    Fiber Length       :    2m
    Mounting           :    On adapters fitted to Slitlamp Tonometer Mounts
    Safety Filter      :    Fixed filter OD 4 @ 532nm
    Beam Divergence : Cone angle of 20
___________________________________________________________________
Laser Indirect Ophthalmoscope
    Indirect model       : Keeler All Pupil II
    Retinal Spot size    : 300m nominal at focus with 20D Laser Lens
    Illumination power : From Laser Console or stand alone power source
    Fiber Length          : 3m
LightLas 532  Operator's Manual               Rev. No 01                         Page 22 of 115
    Weight            : Less than 500g without laser attachment
    Safety Filter     : Fixed filter OD 4 @ 532nm
    Beam Divergence   : Cone angle 20
___________________________________________________________________
Endo-ocular Probes
   Probe Types                     :
                         Straight, Curved and Aspirating
   Fiber Length          3m        :
   Safety Filters                  :
                         OD 4 @ 532nm in housing for installation to Operating
                         Microscope before Laser can be fired
    Sterile          :   Sterilized by Ethylene Oxide and a single use
                         device only
    Beam Divergence   : 0.2 NA
 ___________________________________________________________________
Accessories
Safety Filters
    Types                          :   To suit Zeiss, Moeller, Leica and Topcon Operating
                                       Microscopes
      Safety Filter                :   OD4@532nm
LightLas 532  Operator's Manual              Rev. No 01                         Page 23 of 115
3.2     CSO SL980 and SL990 Slitlamp Specifications
The following are the Slitlamp Specifications for the CSO SL980 and SL990 Slitlamps
that are used in the LightLas 532 Photocoagulator Laser System. The SL980 is a Zeiss
clone and the SL990 is a Haag Streit clone. Both Slitlamps have very similar
specifications however the SL980 uses an illumination source below the viewing path
and the SL990 uses illumination from above the viewing path.
      Microscope                   :   Galilean
      Magnification Set            :   5 Step Drum Rotation
      Eyepiece                     :   12.5X
      Magnification Ratio          :   6X, 10X, 16X, 25X, 40X
      PD Range                     :   48.5-80mm
      Diopter Adjustment           :   +/-8
      Slit Illumination            :   6V 20W Halogen Lamp
      Slit Width                   :   0-14mm (SL980) and 0-12mm (SL990)
      Slit Length                  :   1.8  12mm
      Slit Apertures               :   0.3, 5.5, 9, 14mm(SL980) and 0.2, 1, 3, 5, 9, 12mm(SL990)
      Slit Angles                  :   0- 180
      Filters                      :   Red Free, Heat Absorbing, Cobalt Blue
      Movement Ranges
      Longitudinal (In/Out)            :   113mm
      Lateral (Left/Right)             :   108mm
      Vertical (Up/Down)               :   35mm
      Fine movement range              :   10mm
      Chin Rest Range                  :   70mm
LightLas 532  Operator's Manual               Rev. No 01                          Page 24 of 115
 Section 4                     PRINCIPLES OF OPERATION
4.1     General Description
The LightLas 532 Green Laser is an Ophthalmic Laser suitable for performing the
following clinical procedures:
             Retinal Photocoagulation
             Pan Retinal Photocoagulation
             Endo photocoagulation
             Macular Treatments
             Laser Trabeculoplasty
The LightLas 532 Laser system has a wavelength of 532nm, which is in the visible
spectrum and is a green light. A red aiming beam is used to position the treatment
green light beam prior to delivery.
The word LASER is an acronym for Light Amplification by Stimulated Emission of
Radiation. The light from a laser has particular characteristics, which makes it a
valuable tool for medical applications.
             The beam from a laser is collimated which means that the beam does not
              diverge and can maintain a constant diameter over a long distance. This
              means that the Laser beam can be focused to a very small spot with high
              energy and power densities.
             The beam is Monochromatic, which means that it is a single wavelength
              beam and therefore the effects of the beam on tissue are very predictable
              and reproducible.
             The light waves are coherent which means they are in phase with each
              other and do not interfere and generate losses in energy.
The LightLas 532 system consists of a laser console where the green laser is housed
along with the electronic control system and power supplies and accompanies along
with various Laser Delivery Units (LDUs). These LDUs include:
             Slitlamp Integrated into CSO model SL980
             Slitlamp Attachment for CSO model SL990 and other Haag Streit clones.
             Slitlamp Attachment for Zeiss model SL30 Slitlamp
             Laser Indirect Ophthalmoscope (LIO) using a Keeler II
             Endo photocoagulation hand pieces (Endoprobes)
When using these LDUs a microscope Doctor Safety Filter (DSF) is required to
protect the doctor from unexpected reflections causing eye injury during the
treatments. The DSF is mounted in the beam path of the microscope.
LightLas 532  Operator's Manual       Rev. No 01                        Page 25 of 115
All the normal functions of a Slitlamp are available to the operator when using the
LightLas 532 on a Slitlamp unit and when the doctor is using the LIO they will use a
Contact Lens of either 20D or 28D.
On the laser console there is a remote control module that the doctor can remove
from the top of the console and position it close to the treatment location so as to
have easy access to the laser displays and controls. This remote control module is
connected to the laser console by a flexible cable that is coiled up and sits in the
recess area on the top of the laser console.
The doctor must first confirm the patient meets the treatment requirements of the
indications and contraindications before proceeding with any treatment. Typically
the doctors or their assistant will verify that the laser and delivery unit are operating
correctly before positioning the patient in the Chinrest are for avoiding any patient
inconvenience. This checking includes the laser output and alignment.
The doctor must set the laser power and pulse interval whenever the System is
turned on. It is the responsibility of the doctor to set acceptable power levels and
pulse intervals. It is recommended that always start with a lower power and shorter
pulse interval to reduce any risk of unintended injury to the patient. By default
setting the laser system, the power is set to 0mW, the pulse duration is set to 0.02
seconds and the pulse interval is set to One which means one shot per requested
only. These settings can be altered and saved by the operators or doctors
preference.
Conversely, the doctor can select a repeat pulse mode where the laser is pulsed
repetitively according to the doctors requirements. However, even in this mode, the
laser is always under the control of the doctors the footswitch, which means that
whenever the footswitch is released, there will be no laser output.
The following paragraphs give a general description of the operation of the Laser
System
The laser system console generates a controlled beam of the 532nm wavelength light
that is focused to a small spot so that it can be delivered into an optical fiber that
then connects to one of the Delivery units. The Slitlamp LDUs optical fiber has a
diameter of 200m and is 2 meters long and 3 meters long for the LIO. Special care
must be taken with the fibers not to damage the jacket as this may create extra
losses and may allow the laser beam to be transmitted at the damaged place along
the fiber. Therefore the fiber should be kept off the floor and away from sharp edges.
The 532nm wavelength green laser light is primarily used as a source of energy to
heat the tissue and thereby cause photocoagulation. The laser beam is directly
applied to the treated tissue and absorbed by the melanin pigment within the retinal
pigment epithelium and the choroid. This absorption converts the light energy into
LightLas 532  Operator's Manual       Rev. No 01                           Page 26 of 115
heat energy which raises the temperature of the tissue being treated producing
thermal coagulation of the protein. The green laser beam is readily transmitted
through the cornea, lens, and vitreous regions of the eye. If the patients eye does
not allow for good transmission or introduces some dispersion of the beam then the
patient is not suitable for this type of laser treatment. Increasing the laser power and
pulse duration will generate more heat and therefore the coagulative effect will be
greater.
If the power or duration of exposure is too high then the surrounding tissue may
sustain some damage. Therefore, a careful selection of the power and pulse
duration is essential to a successful treatment.
Different Types of LDU
For the Slitlamp Delivery Units and LIO, the laser beam is delivered into the patients
eye as a focused spot that can be positioned accurately by the doctor to the
treatment site. When using the LIO the laser beam is delivered through a Contact
Lens that is held by the doctor and assists in positioning the laser beam on the site
and setting the desired spot size. For the Slitlamp delivery unit the spot size at the
treatment site is adjustable and set by the doctor according to the type of treatment
to be used. The spot size selector is located on the delivery unit attached to the
Slitlamp and can be set from 50m to 1000m in a continuous adjustment for the
Integrated SL980 design. As for Attachment LDU, it can be selected from 50m to
500m.
When using the Endoprobes, the doctor will use an Operating Microscope to view
the patients eye. These probes are inserted into the eye and used in very close
proximity to the treatment site (almost in contact). The Endoprobes are sterile
devices intended for direct patient contact and are a purchased item with a sterility
guarantee.
For each LDU, a Delivery Key is used by the laser console as a means of
determining which type of LDU is connected. The Delivery Key is required because
each type of LDU has a different amount of loss through the optical elements and
therefore the output power factor calibration will be different for each. The
Endoprobes have the least loss of all the LDUs because the only losses are through
the fiber itself and in the coupling of the laser beam into the fiber. The LIO has more
loss than the Endoprobes as it has a collimating system, mirror, and focusing lens for
the laser beam to be transmitted through and all of these have some contributing
losses. The least efficient of the LDUs is the Slitlamp delivery unit. There are many
optics in this unit due to the spot size adjustment zoom system so the losses are the
greatest. Also when the small spot sizes are selected there may be some aperture of
the beam that contributes to the losses.
LightLas 532  Operator's Manual      Rev. No 01                          Page 27 of 115
When setting up the laser unit for the operation, the correct type of Laser Delivery
Unit must be connected along with the Delivery Key that accompanies it. If no
Delivery Key is inserted then the warning message Delivery Key Not Found on the
LCD screen panel and system will wait for correction or reinserted before normal
console operation resume.
The Delivery Key is also an additional safety feature that prevents unauthorized use
of the laser unit. It is attached to the fiber for each of the LDUs to eliminate any risk
of inserting the wrong Delivery Key. It is an essential requirement in order to ensure
that the correct calibrated power level is delivered to the patient.
The following paragraphs describe the actual operation of the system
The system consists of two major parts: the console and the LCD touch control panel
integrated with computer platform
Inside the Laser Console there are several operating components that put together
to provide the output Laser beam such as:
             Laser Diode (808nm)
             Laser Cavity and optics system
             Thermal Electric Coolers and Driver units
             Electronic Microprocessor control system
             Power supply
First of all, main source power must be connected to the laser console system before
the system is enabled to function accordingly. Secondly, a blue LED backlight power
switch, located at the bottom of the screen (refer to fig. 4.3), on the LCD control
panel display needed to be enabled and wait for system software to boot up before
proceed to the next procedure (refer to fig. 4.1 - 4.2). Once the software is properly
boot up, then the key-switch is inserted and turned to the ON position (with the
Emergency switch in the out or OFF position). And then the console system
microprocessor controller will perform some internal checks to verify that the
machine is functioning as it should be. Few warning messages such as, "BBF
Temperature Not Ready", "LBO Temperature Not Ready" ...etc. will display on the
LCD when the console power is ON. This process usually takes less than few
seconds. If the temperature setting up process time is out of specification (> 5mins),
there will be an error code shown on the LCD display (for more detailed refer to
troubleshooting section of this manual).
LightLas 532  Operator's Manual       Rev. No 01                           Page 28 of 115
                        Figure 4.1 System software start up screen shot
         Figure 4.2 System software boot up ok and system is "Standby" mode
LightLas 532  Operator's Manual          Rev. No 01                      Page 29 of 115
All operating conditions and switches are shown on the LCD control panel. The LCD
control panel display consists of:
              Laser Power
              Laser Power Pulse Duration
              Pulse Interval
              Accumulated number of pulses
              The type of LDU connected
              Aiming intensity
              Mode of operation
              SP Mode Selection
              Customized treatment configuration
              Query or Help functionality
The mode of operation is an important function display because when the laser is
turned ON STANDBY mode is automatically selected, which prevents any accidental
firing of the LightLas 532 Laser System with LCD panel. In STANDBY mode, the
footswitch is disabled and the shutter module blocker will obstruct the beam path is
closed.
Only Standby button switch is toggled, the system will be in treat mode. Then the
footswitch and shutter are now enabled and the aiming beam is turned on. If the
footswitch is pressed, the Green laser beam will be delivered into the fiber. The
system will turn back to STANDBY mode in the following situations:
               No controls are operated for 10 minutes
               Any warning or error condition occurs
Prior to activate the Treat mode, it is recommended that all operating conditions are
to be set correctly such as patient positioning, power selection, pulses duration,
interval duration, aiming beam intensity, spot size and illumination intensity. This will
prevent the likelihood of accidental firing of the Green laser or unintentional delivery
during the set up stages.
Output power distribution can fine tune through an up/down arrow switch button on
the LCD touch control panel. The power setting will remain the same whenever the
power is on which means the default setting screen will be primary unless it is
replaced by another setting. The power can be adjusted from 50 to 2000 mWatts.
The pulse duration can be adjusted from 0.01 secs to 3.0 secs. by pressing the action
key switch buttons on the LCD touch control panel. Similarly, the Repeat Interval
LightLas 532  Operator's Manual        Rev. No 01                        Page 30 of 115
can be set from 0.01 to 3.0s by using the press action switches located directly below
the Repeat Interval display. If the duration is adjusted beyond 3.0 seconds, the
Pulse Duration display will show CW and the laser output will be continuous for
as long as the foot switch is pressed down. If the interval is adjusted beyond 3.0
seconds, the Repeat Interval display will show One and the foot switch will need
to be pressed every time the doctor wishes to fire the laser.
By default setting or when the laser is powered on for the first time, the pulse
duration is 0.02 seconds and the repeat interval is set to One. The laser output
power is set to 0mW. These initial values can be changed by selecting the desired
settings and by using the saving function button on the screen and key in the
customized name. You may retrieve this setting by reopen the file folder.
Inside the Laser System there is a shutter module that completely blocks the beam
path at all times except when the system is in the Treat mode and footswitch is
activated. The microprocessor constantly monitors the electronic sensors position
and their integrity of the shutter at all times. Whenever the system boots up, it will
check for the shutter position to validate if the shutter is engaged and functioned.
The shutter remains closed until doctor initialized the Treat mode. This ensures that
the patient is protected in the case of a misfire. When the footswitch is pressed the
microprocessor will carry out various checks on the status of the laser system
including the correct position of the shutter. After the microprocessor finishes the
system checking, then the shutter will await to be opened or activated. If this is OK
then the Laser Diode will be turned on for the selected pulse duration. There is a
closed loop control system to ensure a stable output pulse. The footswitch must be
released in order for next requested to be operated again. The position of the
shutter will continuously be checked during all operating modes.
A sum of the total delivered Laser pulses is shown on the LCD Control panel located
near the bottom right. A reset button switch is located next to the display button.
You may clear the setting by pressing this button will reset the value.
In the case of an emergency, the Red Emergency Switch can be pushed in and locked
down to cut off all power. Normally power can be turned off by using the key switch.
In order to prevent unauthorized persons from operating the system, the key should
not be left in the keyhole when the Laser System is not in use.
The software shutdown is processed through a push button on the LCD panel
located near the left bottom of screen (refer to figure 4.3). The system will remain
operation unless users requested.
The user/doctor is expected to be trained and have knowledge in the intended use
and application of the Green laser for performing any surgery. In addition, it would
be expected to use the laser system in a clean and controlled environment. When
LightLas 532  Operator's Manual     Rev. No 01                          Page 31 of 115
performing Endo photocoagulation procedures, a sterile surgical site should be used
to reduce the risk of infection. European National Requirements may apply in some
EU countries and are to be observed by those users (Refer to Section 9 of this
manual).
The patient cannot have any influence over the operation and control of the New
LightLas 532 Laser System. Depending on the type of surgery being performed, the
delivery unit being used, and the condition of the patient, the doctor must decide on
the modality of the Laser use and whether or not an assistant is required during the
surgery.
As the laser system is designed to deliver the laser beam to heat the tissue, care must
be taken to avoid dangerous situations that could cause a fire or an explosion. The
Laser should never be fired in the direction of flammable gases or liquids which may
be present in the operating room.
LCD Power
On / Off
Button
                              Figure 4.3 System software is ready to shutdown
LightLas 532  Operator's Manual          Rev. No 01                       Page 32 of 115
4.2 LightLas 532 Laser Controls and LCD Displays
4.2.1 Laser Console
All the LightLas 532 Photocoagulators controls and displays are located either on the
console front panel or the rear panel (refer to fig. 4.1.and 4.2). A detailed description
of each control and display is explained on the next page.
                                                                                                                                                                                                                      LIGHTMED
                                                                                                                                                                                                                LIO
                                                                                                                                                           LIO                                   Delivery
                                                                                                                                                                                                  Key
                                                                                                                                                                                                                            STOP
                  INPUT: 100-230V ~ (Fuse:T3.15AH250V)
                         50/60Hz, 400VA                  DANGER!                                          DANGER!
                                                         Do not remove covers. Shock hazard and           Ne pas ouvrir L'appareil risque de chocs electriques                   Danger/Caution
                                                         accessible laser radiation. Refer servicing to   exposition dangereuse au rayonnement                      Visible and Invisible laser radiation when open
                                                         qualified service personnel.                     Laser direct ou diffuse reparations par service            AVOID EYE OR SKIN EXPOSURE TO
                                                         Risk of explosion if used in the presence of     technique qualifie.                                        DIRECT OR SCATTERED RADIATION
                                                         flammable anesthetics.                           Risques d'explosion si utilise en presence
                                                                                                          d'anesthesiques inflammables
                                                         ACHTUNG!
                                                         GEHAUSETEILE NICHT ENTFERNEN                     For grounding reliability
                                                         Gefahr eines elektrischen Schlages               connect only to with a "Hospital
                                                         Laserstrahlung zuganglich.                       Grade receptacle".
                                                         Wartungsarbeiten nur durch qualifizierten        Complies to the requirements of
                                                         Kundendienst.                                    21CFR, Chapter 1, Subchapter J
                                                         EXPLOSIONSGEFAHR
                                                         Dieses Gerat ist nicht fur den Betrieb in
                       AC MAINS INPUT                    explosiongefahrdeten bereichen bestimmt
                                                                                                                                                 FOOTSWITCH                 DOOR
                                                                                                                                                                         INTERLOCK
                          WARNING
                            Risk of fire
                        Replace only with
                      fuse as marked above
                                                              Figure 4.4
                                               Laser Console Controls and LCD Displays
Legend
1. Emergency Stop Switch                                                                                                                             2.          Key Switch
3. Laser Aperture                                                                                                                                    4.          Delivery Key Connector
5. LIO Illumination Control                                                                                                                          6.          LCD Control Panel
7. LIO Power                                                                                                                                         8.          Main Power Inlet
9. Footswitch Connector                                                                                                                              10.         Remote Interlock Connector
11. LCD Control Panel Power Switch                                                                                                                   12.         Power Control Adjuster or Dial
LightLas 532  Operator's Manual                                                                                     Rev. No 01                                                                                                    Page 33 of 115
4.2.2 LCD Display Panel
                                            Figure 4.5
                                   LCD Panel Display and Control
Legend
13. Mode Indication (TREAT / STANDBY)               14. Type of Delivering System Indicator
15. User Configuration Indication                   16. Date and Time Indicator
17. Total Laser Shot Counter Display                18. Counter Reset Switch
19. Aiming Beam Intensity Indicator Display         20. Aiming Beam Intensity Setting Switches
21. Manual Inquiry                                  22. Loading Profile Inquiry
23. Saving Inquiry                                  24. Repeat Interval Setting Switches
25. Repeat Interval Display                         26. Exposure Duration Setting Switches
27. Exposure Duration Display                       28. SP Mode & Selection Display Icon
29. Preset Power Display                            30. SP Mode Selection Icon
31. Buzzer Control Icon
LightLas 532  Operator's Manual            Rev. No 01                           Page 34 of 115
1.   Emergency Stop Switch
     This switch is provided a fast response shutdown of the laser system in the event
     of some serious problem occurring. It is a RED color push switch that locks
     down when pushed and in, all internal power will be removed. In order for
     system to restore the power, the button switch must be twisted and released it.
2.   Key Switch
     This key switch is the main power ON/OFF switch. The power can only be turned
     on by inserting the key and rotating clockwise to the ON position. In the ON
     position the key cannot be removed. The key should be stored in a safe and
     controlled place.
3.   Laser Aperture
     The Laser Delivery Units fiber is connected here. The fiber connector must be
     fully screwed in since there is an interlock switch which must engaged in order
     for the Laser to function. No laser beam can be delivered through unless the
     fiber is securely attached.
4.   Delivery Key Connector
     Each Delivery Unit has its own type of Delivery Key connector that must be
     fitted to this socket so the microprocessor can recognize it. Always make sure
     the correct Delivery Key is inserted for the LDU that is being used.
5.   LIO Illumination Control
     When the LIO is connected to the LightLas 532 Laser Console, this control knob
     can be used to adjust the intensity of the Illumination lamp.
6. LCD Control Panel
     This LCD Control Panel locates in front of the Laser Console and can easily be
     removed by the operator and placed close to the site of the laser treatment in
     order to maintain good control over the laser settings and displays. A cable
     connects the LCD Control panel to the Laser Console and it is coiled up under the
     hinged top cover of the Laser Console. This is a touch panel control and
     software system embedded it. All controls are shown on the LCD panel including
     Duration, Interval, Aiming intensity, Output power, SP Mode selection, and Shot
     counter.
7.   LIO Power
     This connector is used to provide the power source the LIO Illumination.
LightLas 532  Operator's Manual     Rev. No 01                         Page 35 of 115
8.   Mains Power inlet
     This socket is used to connect the Laser Console to the mains power. The input
     voltage can be the range of 100 to 230 VAC as the internal PSU is an auto-ranging
     module.
9.   Footswitch Connector
     This connector is fitted for the footswitch module which is the laser trigger firing
     mechanism On/Off switch. This footswitch can be in wire or wireless module.
10. Remote Interlock Connector
      It is a regulatory requirement that the LightLas 532 have this safety feature
      connector available. Two wires can be wired out from the interlock switch to
      the treatment doors switch and once the door opens the circuitry will be
      opened causing the system to be disabled. At this time, the warning message
      inL rE-F will show on the remote control panel display. Once the door shuts
      the system will go default back to STANDBY mode. By default setting a dummy
      Interlock connector is supplied with each console and it must insert in order
      for the system to operate correctly.
11. LCD Control Panel Power Switch
     This is a power switch for the LCD control panel. By turning on this switch, the
     system software will be activated only not the console system itself therefore do
     remember to power on the console in order to establish the communication.
12. Power Control Adjuster or Dial
     This control is used to adjust the laser output power. By default setting the laser
     power is at set at zero unless the reconfiguration is made. The setting can be
     adjustable from 50 mW to 2000 mW and by rotating the control clockwise will
     increase the power value and counter-clockwise will reduce it. The setting will be
     reset it when power is down.
13. Mode Indication (TREAT / STANDBY)
     This indication can be toggled the two modes selections of Treat or Standby.
14. Type of Delivering System Indicator
     This display panel will indicate selected type of delivering system when the
     appropriate delivery key is inserted or applied. Always ensure the delivery key is
     inserted in order for system to function otherwise a warning message Delivery
     Key Not Found will show in the main LCD panel. There are three types of
     delivering systems: Slit Lamp, LIO, and ENDO.
LightLas 532  Operator's Manual      Rev. No 01                           Page 36 of 115
15. User Configuration Indication
     This box will display the user name configuration where appropriate user
     preference can be loaded from the folder.
16. Date and Time Indication
     This display will show the current time and date. Reconfiguration is required for
     system to show the corrected time and date.
17. Total Laser Shot Counter Display
     This display will indicate the sum of the total laser shots being fired during the
     treatment.
18. Counter Reset Icon
     This icon switch will reset the total laser shot counter to zero.
19. Aiming Beam Intensity Level Display
     This display will indicate aiming beam intensity level. The level scale starts from
     1 to 10 and the higher number indicates the higher intensity. The maximum
     power can be applied to patients eye is round 1.omW.
20. Aiming Beam Intensity Control Switches
     These controls switches can adjust the aiming beam brightness of through two
     switches (up / down).
21. Manual Inquiry Icon
     This icon will provide the detailed operator manual at any requested time.
22. Loading Customized Configuration Profile Inquiry
     This inquiry icon will able to retrieve any customized configuration file.
23. Saving Icon
     The system will store any customized configuration profile at requested time.
     This icon is used to store the profile at user.
24. Repeat Interval Control Switches
     These switches are used to set the repeat interval duration, which is the time
     between each pulse of the treatment laser. Similar to the Duration switches, the
     left hand control will decrease the interval and the right hand control will
     increase the interval. In this mode the repeat pulse rate cannot be set higher
     than a 50% duty cycle. This means that the laser fire duration cannot be higher
     than the repeat interval duration. It means also that the repeat interval duration
     is greater than or equal to the exposure duration when pressing the down
     setting switch. The minimum interval is 0.01 second, and the maximum interval is
LightLas 532  Operator's Manual       Rev. No 01                           Page 37 of 115
     3.0 seconds. If the interval is adjusted beyond 3.0 seconds, then the Repeat
     Interval display will show One.
25. Repeat Interval Display
     This display will show the selected interval value and it ranges from 0.01 to One
     second.
26. Exposure Duration Setting Switches
     These two switches control the duration of the exposure time that the
     treatment laser is given to the patient each time the footswitch is pressed in the
     Treat Mode. The left hand control will decrease the duration and the right hand
     control will increase the duration. The minimum duration is 0.01 seconds and the
     maximum duration is 3.0 seconds. If the duration is adjusted beyond 3.0
     seconds, then the system will enter the continuous pulse mode. In this mode,
     the laser will output continuously until the doctor/user releases the footswitch.
     When this mode is activated, the Duration display will show Con.
27. Exposure Duration Display
     The system will store any customized configuration profile at requested time.
     This icon is used to store the profile at user.
28. SP Mode & Selection Display Icon
     This icon is used to enable and disable SP Mode function and selected sub-
     threshold levels will also display. The upper information is the selected duty
     cycle and the bottom is the ON or exposure time. The denominator is 2000s
     and numerator is appropriate ON time. The ratio of the two will be duty cycle.
29. Preset Power Display
     This display will show the set power level and the display will change as the
     power is adjusted. By default setting the laser power is at set at zero unless the
     reconfiguration is made. The setting can be adjustable from 50 mW to 2000 mW
     and by rotating the control clockwise will increase the power value and counter-
     clockwise will reduce it. The setting will be reset it when power is down.
30. SP Mode Selection Icon
     This drop down menu icon will enable the appropriate user preference sub-
     threshold duty cycle. There are five preset configurations and they are as follows:
     7.5%, 10%, 12.5%, 15%, and 20%. The ON time configurations are as follows: 15os,
     200s, 250s, 300s, 350s, and 400s.
LightLas 532  Operator's Manual      Rev. No 01                         Page 38 of 115
31. Buzzer Control Icon
     This icon control knob can be used to adjust the volume of the laser fire audible
     warning. However the audible warning cannot be turned off.
     Note: There are cooling fans inside of the Laser Console. This forced air is
     used to cool down the electronics component and specially the laser diode and
     cavity in the system. Therefore it is very important that the intakes cooling fans
     are not blocked otherwise the laser will overheat and an error condition will
     generate.
LightLas 532  Operator's Manual      Rev. No 01                         Page 39 of 115
4.2.3 Slitlamp Delivery Unit
There are two types of Slitlamp delivery systems: Integrated System and Attachment
LDU. More detailed breakdown description of these delivery systems can be found
below and next few pages.
                                                         CAUTION/DANGER
                                                          VISIBLE LASER RADIATION
                                                       AVOID EYE OR SKIN EXPOSURE
                                                          TO DIRECT OR SCATTERED
                                                                 RADIATION
                                                   CLASS 4 LASER PRODUCT EN60825-1(1994)
                                              Figure 4.6
                                   Integrated Slitlamp LDU Controls
LightLas 532  Operator's Manual             Rev. No 01                                    Page 40 of 115
                                             Figure 4.7a
                                   Attachment Slitlamp LDU Controls
                                          Fig. 4.7b
                 Truspot Attachment Slitlamp LDU Controls (New version)
LightLas 532  Operator's Manual             Rev. No 01                   Page 41 of 115
1. Optical Fiber
     This optical fiber connects between the Slitlamp LDU and the Laser Console. The
     treatment laser and aiming beams are focused into the fiber.
2. Zoom System
     This optical system allows the laser beams spot size to be adjusted at the
     treatment site from 50 to 1000 m by rotating the control.
3. Spot size indicator
     As the zoom system is adjusted the actual spot size at the treatment site is
     shown in this indicator window.
4. Objective focus lens
     This is part of the Slitlamp unit and the Laser beams are also focused by this lens
     to the treatment site. The focus length is 117mm.
5. Magnifier Control
     The magnification as seen by the doctor is adjusted using this control. The
     selected magnification is shown on the knobs. A larger magnification will give a
     larger image of the treatment site.
6. Binocular and eyepieces
     The doctor looks through the eyepieces to view the patient. The Interpupillary
     Distance can be adjusted as well as the individuals Diopter settings for each
     eyepiece.
7. Doctor Safety Filter
     This safety filter is a standard set-up in every Slitlamp LDU and is located at
     microscope housing. This filter will prevent back reflections during laser
     treatment which may cause injury to the doctors eyes. Usually the filter is a
     fixed optic lens however it is also an option to install a moving filter. The orange
     filter provides protection >OD4 @ 532nm
8. Micromanipulator Joystick (old version type only)
    This joystick is used for doctor or operator to accurately position the laser beams
    spot within the central portion of the illumination field of the view.
9. Focus Set Screw
     This screw is used to set the viewing focus of the microscope to be in sharp
     focus on the Target Rod. Tightening this screw into the housing, the focus point
     is moved away from the Target rod and it is towards the user. Loosening this
     screw and then pushing the microscope housing up firmly against the screw sets,
     the focus more towards the patient.
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10. LDU Spot Focus Adjuster (old version type only)
     In order to set the correct focus point for the treatment and aiming laser, adjust
     this screw to get the smallest spot size possible at the focal plane.
11. LDU Spot Centering Adjuster
     This is applied when the laser delivery unit is installed in order to accurately set
     the laser beam in the center of the field of view in the horizontal plane. It is
     located on the LDU mounting arm above the Tonometer mount. By moving the
     mounting arm right or left and swing this adjuster right or left until reaching
     position you need. If necessary repeat the adjustment until the alignment is
     correct.
Slitlamp LDU system can be integrated with two types of the slitlamp that carry by
Lightmed are as:
       CSO SL980 (Integrated with Slilamp)
       CSO SL990 (Can be integrated with attachment slitlamp LDU system)
        More detailed breakdown is shown in section 4.2.4 (page 52 to 55)
LightLas 532  Operator's Manual       Rev. No 01                           Page 43 of 115
    4.2.4 Laser Indirect Ophthalmoscope (LIO)
    The controls on the LIO (refer to Fig. 4.8 a-b) are used to adjust the position of the
    treatment laser beam to the Illumination spot. All other controls either adjust the
    Illumination spot or the fitment of the unit for the doctor. More detailed breakdown
    description can be found in the following pages.
                                                                                         10
3
                                                                                              2
                              Figure 4.8(a) Front View of LIO LDU Controls
                              Figure 4.8(b) Top View of LIO LDU Controls
    LightLas 532  Operator's Manual          Rev. No 01                     Page 44 of 115
1.   Optical Fiber
     The optical fiber connects between the LIO and the Laser Console. The
     treatment and aiming beams are focused into the fiber.
2.   Zoom System
     This optical system focuses the laser beams to the correct spot size suitable for
     the intended application. The spot size can only be adjusted by the use of hand
     held Laser lenses.
3.   Vertical Treatment beam adjuster
     This control, which can be adjusted from either side of the zoom housing, is used
     to adjust the vertical position of the Laser beams with respect to the illumination
     spot.
4.   Illumination spot size control
     This controls the adjustment from either side of the illumination housing and is
     used to select the 3 different spot sizes and the defocus setting.
5.    Eye Housing Adjustment and Locking Control
     This control is used to adjust from the entire eye piece housing up / down
     position and tighten up by locking it the screw.
6.   Illumination spot height adjuster
     These two controls on either side of the LIO are used to change the position of
     the illuminated spot with reference to the field of view of the doctor.
7.   Eyepieces
     The eyepieces are fixed to the LIO so it can be adjusted to the suitable
     interpupillary distance for the doctor. The special optical safety filters are built in
     to protect the doctors eyes from possible back reflections of the laser beam
     treatment.
8.   Headpiece
     The headpiece forms part of the LIO and is adjustable to suit any size of heads.
     The adjustment knobs can be found on the top and the back of the LIO. In
     addition on the side is control that allows the Illumination and Laser housings to
     the lifted up and out of the doctors field of view.
9.   Illumination Cable
     This cable connects to the Laser Console front panel and provides the power for
     the Illumination Lamp.
LightLas 532  Operator's Manual        Rev. No 01                           Page 45 of 115
10. Illumination aperture filtering control
      This control is used to filter out application required by physician or user. There
      are three types of filters such as, Red Free, Heat Absorbing, and Cobalt Blue.
LightLas 532  Operator's Manual       Rev. No 01                          Page 46 of 115
4.2.5 Two types of Integrated CSO SL980 and SL990 Slitlamp Controls
      Breakdown
The CSO Slitlamps can be used as a standard diagnostic tool and all the standard
Slitlamp functions are available.
The following figures 4.6 and 4.7 show all of the controls that can be found on the
Slitlamps and the description of the components.
CSO SL980 Slitlamp Controls
LightLas 532  Operator's Manual    Rev. No 01                       Page 47 of 115
CSO SL980 Slitlamp Controls continues...
                      Figure 4.9 SL980 Slitlamp Parts List and Controls
LightLas 532  Operator's Manual         Rev. No 01                       Page 48 of 115
CSO SL990 Slitlamp Control
LightLas 532  Operator's Manual   Rev. No 01   Page 49 of 115
CSO SL990 Slitlamp Controls continues...
                                           Figure 4.10
                              SL990 Slitlamp Parts List and Controls
LightLas 532  Operator's Manual           Rev. No 01                  Page 50 of 115
Section 5                      INSTALLATION
5.1 Introduction and Requirements
It is strongly recommended that the manufacturer or its authorized agent install the
LightLas 532 Laser System at the operator site to ensure that the system is operating
correctly, aligned and calibrated according to specification. After this initial
installation it is the operators responsibility to ensure the laser system is operating
correctly whenever the laser is moved or relocated.
The following procedures should be followed in order to successfully install the laser
system. The checklist and report form should be completed and a copy sent to the
manufacturer. In the event that the report is not sent to the manufacturer then the
manufacturer reserves the right to decline any warranty claims that may be
forthcoming.
The installer should also retain a copy and the customer may keep a copy too.
All precautions care must be taken when installing the LightLas 532 to ensure that
you or others are not exposed to any hazardous laser radiation. Always wear laser
safety glasses suitable for the 532nm wavelength to protect your eyes.
The installation requirements are:
1.   100-230 Volts, 50 or 60Hz AC mains power supply with an earth connection. This
     is a single-phase outlet capable of delivering up to 400 Watts.
2.   A motorized stand that the Table provided with the Slitlamp can be fitted to is
     required if one was not purchased with the Laser system. Ensure the Table is
     fitted securely to the Stand using the supplied screws.
3.   A mains power cable is supplied but the connector may not suit the outlet
     available so it is advisable to have a spare locally compatible cable available. The
     Cable assembly must be CE approved for EU Countries.
4. A suitable room to place the Laser System in that provides for a safe working
   environment is required. As with other ophthalmic equipment a dimly lit room is
   preferred.
5.   The Laser System has the facility to connect a remote door interlock to the Laser
     treatment room. If this option is required then the customer must organize this
     with an electrician and the manufacturer or authorized agent can provide
     instructions on how to connect to the Laser System. The Laser System is
     provided with a Bypass plug in the event that this option is not installed. This
     plug is referred to as the Interlock Key and must be inserted into the back of
     the console, in order for the system to operate. Do not remove this Bypass
     connector unless you intend to install the remote door interlock switches at the
     site. Removing the connector will prevent the Laser from operating.
LightLas 532  Operator's Manual       Rev. No 01                           Page 51 of 115
6.    If the user needs to move the Laser system to a new location it is recommended
     to lock all the movement screws on the Slitlamp and carefully transport to the
     new location. If the new location is at a different facility then the User should
     consider repackaging the Slitlamp Delivery system in its original foam packing
     prior to moving to the new site. This will help to prevent any damage occurring
     to the System. When the relocation is completed then the correct operation and
     functioning of the Laser system should be performed according to the following
     steps in this section and sections 7.2 and 7.3 of this Operator Manual.
7.   The LightLas 532 Laser Console can be relocated easily as it is a portable device.
     When required to be used with the LIO or Endo-ocular Probes the Console can be
     carefully transported to the new surgery location. Treat the Laser Console with
     the same care as should be offered to any precision surgical device. When the
     Laser is set up at the new site check the operation as per Section 5.0 of this
     manual.
8.   When installing the LightLas 532 as a System with Slitlamp onto a Table then care
     must be taken to ensure that the set-up is optimized for the User with all parts of
     the System correctly installed and mounted so that both the Patient and Doctor
     are comfortable and safe during the treatment. There are no specific safety
     issues when installing the System however it is recommended that the
     Motorized Table mains Power cable not be plugged into the same Multiple
     Portable Socket Outlet as the Laser Console and Slitlamp power supply cables.
     Use a separate wall mounted Power outlet.
5.2 Unpacking and Receiving Inspection
When receiving the laser system, there will usually be two cardboard boxes. One will
contain the laser console. Depending on what was ordered, the other may contain
the integrated system, AD delivery attachment kit, or the laser indirect
ophthalmoscope. Refer to figures 5.1 and 5.2 for examples.
                                                    Top Layer: Protection Layer
                                                    Middle Layer: Upper Arm / Lower
                                                    Base Housings / Chinrest / Zoom pc
                                                    / SD Magnifier/ Accessories
                                                    Bottom Layer: Table Top Assy
                                        Figure 5.1
                Packing Carton for Integrated LDU and Slitlamp (Optional)
LightLas 532  Operator's Manual       Rev. No 01                           Page 52 of 115
                              LIGHTMED
                                                           LIGHTMED
                        Console Carrying Case         LDU Carrying Case (Optional)
                   Figure 5.2 Portable Carry Cases for Console and LDUs
Upon receiving the system inspect the packing carton for any signs of mishandling,
which must be reported to the freight handler before the instrument is unpacked. If
there is damage, then the manufacturer reserves the right to decline any warranty
claims that may be forthcoming so it is essential that the freight company will take
full responsibility for any damages.
If the outer cardboard packaging looks OK then you can proceed to remove the
internal packed assemblies (refer to Fig. 5.1). The contents of each layer are:
     1.   The top layer is just a protection layer.
     2. The middle layer contains the Chinrest and Integrated LDU including the
        Zoom assembly, binoculars, eyepieces, target rod, target plate, cross-slide
        shaft and gears, gear covers, spare lamp, manual, mains power cable.
     3. The bottom layer part contains the table top.
The packing checklist is used to confirm the individual layer contents and notify the
manufacturer if any discrepancy. The motorized table is an optional and may be
purchased from the manufacturer.
LightLas 532  Operator's Manual         Rev. No 01                         Page 53 of 115
5.3 Tools and Equipment
In order to be able to effectively carry out a full initial installation of the Green Laser
System the following tools and equipment are required and available from the
manufacturer:
     1.   Laser Power Meter (to measure from 0 to 2 watts CW)
     2. Optical Alignment tool kit, which includes:
           Model Eye
           Laser target tool
     3. Photographic thermal paper (Zap-it or equivalent)
     4. Set of metric Allen keys
     5. Screwdrivers (Philips / Roberson)
It is both essential and mandatory to have the all above listed tools and equipment in
order to assemble or disassemble Lightlas in a correct and safe way
LightLas 532  Operator's Manual        Rev. No 01                            Page 54 of 115
5.4 Setting Up the Laser System Parts
Preparation
All the possible items used during installation of the Green Laser are shown below in
Figure 5.3. From the top left-hand side in a clockwise direction the parts are:
    1. Laser Console
    2. Integrated Laser Delivery Unit Microscope assembly with Zoom unit
    3. LIO Assembly
    4. Fiber Delivery cable
    5. Endoprobe Plug
    6. Endoprobe
    7. 4 Different Delivery Key Connectors
    8. Attachment Laser Delivery Unit (New One without Micromanipulator-Truspot)
    9. Microscope Laser Safety Filter units
    10. Footswitch (including a Signal Receiver and a Footswitch Cable)
                                                      LIGHTMED
   1                                            LIO
                                                                                                                                                           2
                               LIO   Delivery
                                      Key                                              DANGER / CAUTION
                                                                                   Visible laser radiation when open
                                                            STOP                AVOID EYE OR SKIN EXPOSURE TO
                                                                                DIRECT OR SCATTERED RADIATION
  10
                                                                                                                                                                           4
                                                                                                                             WARNING
                                                                                                                           Only use with 532nm Laser
                         9                                           8                                                 7                               6
                                                                Figure 5.3
                                                            Laser System parts
LightLas 532  Operator's Manual                                   Rev. No 01                                                                                  Page 55 of 115
All the items above and the rest of the system should be unpacked from their cartons
and carry cases and inspected for transportation damage and general condition.
Extreme care do not to touch the optic lens or parts and make sure all the items are
available.
The System consist of two major parts as follows:
             LDU system (Slitlamp: Integrated or Attachment / LIO / Endoprobe)
             Console
LDU Systems
5.4.1 Slitlamp Integrated LDU
Prior to install the Slitlamp Integrated system, ensure all the corrected setup and
equipment are in placed to proceed the installation steps.
System Part(s):
                  Upper Arm Housing
                  Lower Base Housing
                  Table top
                  Accessories (binocular, cover, chinrest, and target rod)
Procedures:
1. Unpack all the packaging items from the cartoon box
2. Lay the ready to go table on the final destination location (well level) and ensure all
   the accessories are installed including rail and joystick slide pad (refer to fig. 5.4)
3. Ensure the voltage and fuses rate setting are set up correctly, as default setting is
   230VAC (refer to fig. 5.5a-d)
4. Take the Slitlamp upper arm housing and lower base housing with cross-slide shaft
   assembled (refer to fig. 5.6)
5. Assembled the upper and lower housing together by securing the screw at rear
   end of lower housing (refer to fig. 5.7)
6. Position the Slitlamp assy back to the gear rail and gently wheel it back and forth
   to get it smooth out
7. Ensure the Slitlamp assy is horizontally parallel in x-axis
8. Place the gear cover
9. Install the Chinrest assy and connect the fixation lamp to the source box and plug
   in the source power connection (refer to fig. 5.5a)
LightLas 532  Operator's Manual         Rev. No 01                           Page 56 of 115
    10. Clamp the fiber support arm into its holder
                                Figure 5.4 Slitlamp table top ass'y
    Note: The table top can be accommodated in two types of stand that the Lightmed
    manufacturer such as, T and C types of table stand. All appropriate installation
    guides are inserted in the packaging .
Power source                                                                        Slitlamp power
connection                                                                          source connection
                                                 Fixation lamp connection
                       Voltage rate setting
                        Figure 5.5 (a) Rear view box connection
    LightLas 532  Operator's Manual           Rev. No 01                   Page 57 of 115
                Figure 5.5 (b) Removal of fuse holder
               Figure 5.5 (c) Removal of fuses and check the fuses rate
LightLas 532  Operator's Manual        Rev. No 01                        Page 58 of 115
       Figure 5.5 (d) Removal of voltage setting block and reinsert it back upon completion
                                                                           Chinrest Ass'y / Zoom PC
                                                                             Dust Cover / Accessories
                                                                            Magnifier Assy or SD pc
Lower Base Housing
                                                                                 Upper Arm Housing
         Binocular
                                          Figure 5.6 Slitlamp Assy
       LightLas 532  Operator's Manual         Rev. No 01                    Page 59 of 115
                                                                       Housing Screw
                  Figure 5.7 Assembled Upper and Lower Housing Screw
                                                                    Upper Arm Housing
Lower Base Housing
                                      Figure 5.8
                Slitlamp mounted onto Table Top ready for Integrated LDU
LightLas 532  Operator's Manual      Rev. No 01                       Page 60 of 115
         5.4.1A Integrated Slitlamp Delivery Unit (System Parts) continue
         Prior to continue the Integrated Slitlamp delivery unit parts system installation,
         ensure the slitlamp integrated main body housing and table top are corrected setup
         and equipment are in place.
         System Part(s):
                      SD Housing
                      Zoom Piece
         Procedures:
         10. Ensure the locking screw is loosen prior to slide in the Slitlamp delivery unit (refer
              to fig. 5.9)
         11. Slide the SD magnifier pc into the mounting plate arm and ensure it fully reach to
              the end of the stopper (refer to fig. 5.10)
         12. Secure the locking screw and lock the housing by tightening the screw (refer to fig.
              5.11)
         13. Remove the zoom pc from the box and align the keyway against the delivery
             housing (refer to fig. 5.12-5.13) and rotate it in
         14. Ensure zoom pc is all the way in and the spot size numbering indicator is facing
              towards operators end
         15. Proceed to pre-check / alignment section on page 77-80 upon completion of pre-
             installation procedures
Chrome Stop screw
                              Figure 5.9 Slitlamp arm ready for Delivery housing
         LightLas 532  Operator's Manual        Rev. No 01                         Page 61 of 115
                     Figure 5.10 Fit Delivery unit housing to the Slitlamp
                    Figure 5.11 Lock the housing securely to the Slitlamp
                        when it is pushed against Chrome Stop screw
LightLas 532  Operator's Manual         Rev. No 01                          Page 62 of 115
                                                                               Large Keyway Slot
    Figure 5.12 Align the keyways then fit the Zoom unit to the Delivery housing
                    Figure 5.13 Rotate the Zoom housing to the end stop
LightLas 532  Operator's Manual        Rev. No 01                        Page 63 of 115
5.4.1B Attachment Slitlamp Delivery Unit
Prior to install the Attachment Slitlamp delivery unit, ensure all the corrected setup
and equipment are in placed to proceed the installation steps.
System Part(s):
             Tonometer Mounting block (Haag Streit style / Zeiss 30SL / SYL9000)
             Attachment arm (Haag Streit style / Zeiss 30SL / SYL9000)
             Mounting screws (Haag Streit style / Zeiss 30SL / SYL9000)
             Safety Filters (only for combination system)
             Micromanipulator joystick
             New Modified Illumination Tower (Zeiss 30 SL type only)
Procedures:
1. Place the appropriate mounting post into the magnifier assy and secure with the
   correct mounting screw (refer to fig. 5.15a-c)
2. Swing the slitlamp tower aside prior to fit the appropriate whole attachment body
   into the mounting block (refer to fig. 5.16a-c)
  If this is the Zeiss 30SL attachment LDU type (refer to fig. 5.14a-b), a minor
  modification required prior move on to the next step:
  2a. Place a target rod
  2b. Turn on the slitlamp and set aperture setting to the smallest
  2c. Mark on the aperture spot size with pencil
  2d. Remove the old illumination tower and replace with newly modified one
  2e. Verify the new tower against the mark on target rod aperture spot and align
      and lock if it is confirmed
  2f. Align the spot position by adjusting the mirror if required
                Figure 5.14 (a)                            Figure 5.14 (b)
         Original Illumination Tower            New modified Illumination Tower fitted
LightLas 532  Operator's Manual       Rev. No 01                          Page 64 of 115
3. Attach the micromanipulator joystick to the LDU main body for the old version
   type only (refer to fig. 5.16a-c)
4. Proceed to pre-check / final alignment section on page 81-84
                               Figure 5.15 (a) Haag Streit
                  Attaching Tonometer mount ready for Attachment LDU
                             Figure 5.15 (b) Zeiss 30SL
         Attaching the Tonometer mount and Attachment LDU Mounting Arm
LightLas 532  Operator's Manual     Rev. No 01                        Page 65 of 115
                           Figure 5.15 (c 1) Lightmed SYL9000
                Attaching Tonometer mount ready for HS Attachment LDU
                               Figure 5.15 (c 2) Lightmed SYL9000
                    Attaching Tonometer mount ready for AD Attachment LDU
LightLas 532  Operator's Manual      Rev. No 01                     Page 66 of 115
                            Figure 5.16 (a) Haag Streit
   Mounting the whole attachment LDU to Tonometer mount & micromanipulator
                         Figure 5.16 (b) Zeiss Style 30SL
   Mounting the whole attachment LDU to Tonometer mount & micromanipulator
           Figure 5.16 (c) Lightmed SYL9000 Mounting the whole attachment
                      LDU to Tonometer mount & micromanipulator
LightLas 532  Operator's Manual    Rev. No 01                      Page 67 of 115
 5.4.2     Laser Indirect Ophthalmoscope LDU (LIO)
   Prior to install the LIO delivery unit, ensure all the corrected setup and equipment
   are in placed to proceed the installation steps.
   Accessories:
             LIO fiber
             LIO Delivery System set
   Procedures:
    1. Take a LIO delivery fiber and remove the fibers protector one end at a time
       and clean it with alcohol prior to install to the console aperture and LDU (refer
       to fig. 5.17)
    2. Plug in its delivery key and light source power connector (refer to fig. 5.18)
    3. Make sure the fiber and the cable are fitted to the strain relief fittings on the
       LIO headpiece (refer to fig. 5.19)
    4. Proceed to pre-check / final alignment section on page 85-86
     Figure 5.17 Fiber tips cleaning            Figure 5.18 LIO connections in console
Figure 5.19 LIO LDU fiber connection
LightLas 532  Operator's Manual        Rev. No 01                         Page 68 of 115
5.4.3    Endoprobes LDU
The endoprobe is sterilized single use device therefore there will be no installation
procedures involved however, do want to ensure that the endoprobe packaging is
not being opened prior to the treatment.
Two types of Endoprobes carry by Lightmed are:
    Straight (P/N 620009)
    Curved (P/N 620010)
Ensure Endoprobe plug is fitted prior to load to console laser aperture (refer to fig.
5.20)
                                                                        Fiber
                                     2
                                                          Fiber probe
                                          Fiber Nut
                                   Eyes                   Lockin
                                                          g
                        Figure 5.20 Endoprobe plug installation
Follow the pre-check procedures on the page 86 for further process.
LightLas 532  Operator's Manual             Rev. No 01                         Page 69 of 115
Laser Console
Prior to install the laser console device unit, ensure all the corrected setup and
equipment are in placed to proceed the installation steps.
Accessories:
          Power cord (110 or 220 VAC type)
          Delivery key (Slitlamp / LIO / Endoprobes)
          Footswitch (wire or wireless)
          Optical fiber (link from console aperture to the LDU could be Endoprobe
             or standard delivery one)
          Interconnector (Y-modified combination connector / treatment door
             switch / default dummy connector)
          On/Off Switch Key
Procedures:
1. Position the laser console onto the mounting plate and to the right side of the
   Slitlamp on the table top
2. Connect or fit all appropriate connectors (power cord, delivery key, interlock,
    footswitch, key switch, and Endoprobe or standard delivery fiber)
   2a. If this interlock is Y-modified connector, ensure the safety filter and YAG
        interlock connections are well fitted (refer to fig. 5.21b)
3. Ensure all the connections are fitted no leftover since the improper connection or
   no connection will result the system not functioning properly (refer to fig. 5.21a-c)
Note: Be extreme careful about the delivery fiber connection. The delivery fiber with
      the large fiber holder end with delivery key attached is connected to the
      console aperture and the another end is connected to appropriate delivery
      system (refer to fig. 5.21c)
Take special care when preparing the fiber to not stress the cable. Hold the
connector when removing the protector caps from each end. Never pull on the
cable or the cable sleeve as the fiber may be damaged
LightLas 532  Operator's Manual      Rev. No 01                          Page 70 of 115
                     Figure 5.21 (a) Standard System connection set-up
                  Figure 5.21 (b) Combo System Y-Joint connection set-up
          Figure 5.21 (c) Sample of Delivery Fiber and Delivery Key Connection
LightLas 532  Operator's Manual        Rev. No 01                         Page 71 of 115
5.5 Pre-check / Alignment Procedes
5.5.1 Pre-check Laser console operation
Prior to pre-check the laser console device, ensure all the corrected installation or
setup are in placed to proceed the following steps.
Procedures:
1. Reset the emergency pushbutton by unscrewing outward position
2. Power on the console by turning the key switch
3. Verify if the system passes the self-checking mode if not, proceed to
   troubleshooting section otherwise proceed to next step
4. Confirm if the remote control will reset to the standard operation mode (refer to
   fig. 5.22a-d)
5. Ensure the safety filter is installed prior trigger and fire the laser (refer to fig. 5.23)
6. Ensure the appropriate optical fiber (Endoprobe / standard delivery fiber) is
    attached from the console to the LDU system (refer to 5.24)
7. Check the output power of the system and ensure it is met the specification
   requirements according to the section 7.3 of this manual
Figure 5.22(a) System boot up sequential display #1 Figure 5.22(b) System boot up sequential display #2
Figure 5.22(c) Power on console & system is initializing Figure 5.22(d) System is ready to go
temperature process
LightLas 532  Operator's Manual             Rev. No 01                                Page 72 of 115
                                          Figure 5.23
                                      Safety filter checks
                                           Figure 5.24
                           Attach the Delivery fiber to the Zoom unit
LightLas 532  Operator's Manual          Rev. No 01                    Page 73 of 115
5.5.2     Pre-check / Alignment LDU
When the Laser Delivery unit has been fitted to the Slitlamp the alignment of the
Laser beam with reference to the Slitlamp needs to be checked and adjusted
accordingly. The following procedures will guide you through the entire pre-check
and alignment process. Three different types of LDU systems are detailed as follows:
                 Slitlamp (Integrated / Attachment)
                 LIO
                 Endoprobe
5.5.2.1A Integrated Slitlamp LDU
Prior to pre-check and realign the integrated Slitlamp LDU, ensure all the corrected
installation or setup are in placed (including eye piece dioptre setting, fiber
connection, and console setup and on) prior to proceed the following steps.
Slit Integrity Checkout
 1. Insert the Slitlamp target rod into the Slitlamp or set up a target to view the
      Illumination spot
 2. Set a narrow slit width with low intensity illumination and verify that the slit is
    focused and that the two slit lines are aligned together for the Integrated
    Delivery Unit Slitlamp. If not align, proceed to following steps:
    2a. Unscrew the upper slit alignment screw slightly or lower slit alignment
        depending on your preference (refer to fig. 5.25)
   2b. Choose one end as your starting reference and realign the another
   Note: Do not over loosen the alignment screws completely specially the upper slit
         due to the slit prism module may fall off and break prism mirror
   2c. Confirm it by illuminating the aperture to see if you have aligned them ok
   2d. Process to the next step if it is aligned
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                                                          Upper Alignment
                                                                 Lower Alignment
                               Figure 5.25 Upper / Lower Slit Alignment
Aiming Integrity and Focus Checkout
3. Set spot size to the smallest by adjusting the zoom pc
4. Power on the console and toggle the mode to Treat mode
5. Verify if aiming round spot is reflected on the target rod
6. Adjust the spot size from 50 to 1000 by rotating the zoom pc and verify if the
   spot size is consistently enlarged from smallest to largest at same spot or location
   approximately
7. Loosen up the delivery housing screw and adjust it back and forth until the focus is
    correct and then secure the screw tightly (refer to fig. 5.11)
8. Remove the target rod and place a piece of black tape or thermal paper on the
   chinrest
9. Verify the slit and aiming beam focus are in focus together
Micromanipulator Joystick Movement Checkout
10. Place back the target rod and verify the micromanipulator joystick is moving
    within the full range of the field view when illumination spot is set at largest
    (refer to fig. 5.27a-b) If not, refer to below steps for fine tune-up SD housing:
     10a. Loosen the one of set screw (1.5mm allen key) at delivery housing (refer to
           fig. 5.26) depending the axis that is not reaching to the most far end
           perimeter of view of field
     10b. Realign while viewing through the binocular and repeat until aiming spot is
         with the full range of the field view (refer to fig. 5.27a-b)
     10c. Proceed to next stage once completion of realignment
LightLas 532  Operator's Manual           Rev. No 01                       Page 75 of 115
     Note: Usually this step is unlikely to be realigned unless due to the outer force
           impact during the transportation
                                                                           X-axis Alignment
                                                                            Y-axis Alignment
                   Figure 5.26 Realignment set screw location (X-Y axis)
                         Figure 5.27 (a) Checking Field of View set-up
              Figure 5.27 (b) Checking manipulator operation on the target
LightLas 532  Operator's Manual         Rev. No 01                        Page 76 of 115
Final Testing and Verification
11. Power on the console and ensure its delivery fiber is connected through the fiber
    holder (refer to fig. 5.24)
12. Configure the output power to 50mW, duration 0.2s, interval 0.2s, and spot size
     50
13. Remove the target rod and place a thermal paper or black tape on the chinrest
14. Ensure the appropriate safety filter are attached accordingly (refer to fig. 5.23)
     prior to trigger fire the laser shot
15. Fire the shot and verify if the burn pattern is visible if not, increase the power
16. Increase the spot size to 75 and 100 to see if the burn pattern is also getting
    darker as the spot size increased
17. Verify if everything is consistently and accordingly to the installation, pre-check
    and alignment procedures, then the system is now ready to use accordingly.
Note: At the higher power settings it may be possible to see a faint luminescence
glow at the target site when power setting is set at higher range furthermore this
transmission is under the Class I laser limitation.
LightLas 532  Operator's Manual       Rev. No 01                            Page 77 of 115
5.5.2.1B Attachment Slitlamp LDU
Prior to pre-check and realign the attachment Slitlamp LDU, ensure all the corrected
installation or setup are in placed to proceed the following steps.
Slit Integrity Checkout
1. Set a narrow slit width with low intensity illumination and verify that the slit is
   focused. If the Slitlamp focus is OK then set it to a smaller spot size aperture and
   observe the red aiming beam.
Aiming Integrity and Focus Checkout
2. Set spot size to the smallest by adjusting the zoom pc
3. Power on the console and toggle the mode to Treat mode
4. Verify if aiming round spot is reflected on the target rod
5. Adjust the spot size from 50 to 500 by rotating the zoom pc and verify if the spot
   size is consistently enlarged from smallest to largest
6. Adjust Mounting arms black knob (old type version) or the Delivery Main Body
   locking screw (new type version) to align the focus correctly and then secure the
   screw tightly (refer to fig. 5. 28a-b)
7. Remove the target rod and place a piece of black tape or thermal paper on the
   chinrest
8. Verify the slit and aiming beam focus are in focus together
Micromanipulator Joystick Movement Checkout (applicable only to old version type)
9. Place back the target rod and verify the micromanipulator joystick is moving within
   the full range of the field view and in the center portion when illumination spot is
   set at largest (Applicable only to old version type refer to fig. 5.29)
10. Ensure the illumination spot is reasonable in the center portion of field of view. If
   not refer to below steps for fine tune-up:
       10a. Loosen the mirror nut that clamp to Main body (refer to fig. 5.30) and low
            or raise will center the beam correctly and retighten when achieved or
       10b. Loosen the set screw on the side of Tonometer using 1.5 mm allen key and
            adjust the rod on the Tonometer mount post (refer to fig. 5.30) in aside
            way to achieve the centering beam and retighten when achieved the
            position
       10c. Ensure the set screw is tighten and the rod is removed (keep it in a safe
            location) upon completion
LightLas 532  Operator's Manual       Rev. No 01                         Page 78 of 115
Final Testing and Verification
11. Power on the console and ensure its delivery fiber is connected through the filber
    holder (refer to fig. 5.24)
12. Configure the output power to 50mW, duration 0.2s, interval 0.2s, and spot size
     50
13. Remove the target rod and place a thermal paper or black tape on the chinrest
14. Ensure the appropriate safety filter are attached accordingly (refer to fig. 5.23)
     prior to trigger fire the laser shot
15. Fire the shot and verify if the burn pattern is visible if not also increase the power
16. Increase the spot size to 120 and 200 to see if the burn pattern is also getting
   darker as the spot size increased
Note: At the higher power settings it may be possible to see a faint luminescence
glow at the target site when power setting is set at higher range furthermore this
transmission is under the Class I laser limitation.
As for other types of Attachment Slitlamp LDU such as, the Haag Streit style or Zeiss
30SL system, the alignment techniques are quite similar and the technique is to align
the Slitlamp focus and confirm it is at the same focal plane as the viewing optics.
Then align the Laser beams so that at the smallest spot size setting you can clearly
see that the Laser spot is at its smallest size at this focus plane. If this is OK then all
other spot sizes will match what is shown on the Spot size display.
                                                                           Delivery Main Body
                                                                           locking screw
                             Figure 5.28(a) New Type Version
          Check Slitlamp focus on Target Rod and Laser focus of aiming beam
LightLas 532  Operator's Manual       Rev. No 01                            Page 79 of 115
                         Figure 5.28(b) Old type Version
  Adjust the Attachment LDU Spot Size Focus using the knob on the mounting arm
                          Figure 5.29 Old type version
   Adjusting Micromanipulator Arm to verify Laser Spot is in the Aperture Center
LightLas 532  Operator's Manual    Rev. No 01                       Page 80 of 115
X-axis Adjustment #2
            Set screw
                                                                   Y-axis Adjustment #1
                              Figure 5.30 Old / New type version
              Adjusting sideways movement of Attachment LDU during alignment
    LightLas 532  Operator's Manual    Rev. No 01                     Page 81 of 115
5.5.2.2 Laser Indirect Ophthalmoscope
Prior to pre-check and realign the LIO LDU, ensure all the corrected installation or
setup are in place to proceed the following steps.
Procedures:
         1.     Power on the console and ensure all the connection and connectors are
                in place
         2.     Verify the aiming beam is being delivered correctly from LIO by shooting
                against the wall and set a focal distance of 30cm approximately
         3.     Fit the headpiece onto your head and adjust the two knobs to align the
                Interpupillary distance
         4.     Verify illumination intensity integrity by adjusting the console LIO
                illumination knob (refer to fig. 5.31a) or as for a standalone LIO system
                you may adjust the illumination intensity knob on the LIO unit (refer to
                fig.5.31b )
LIO Intensity
Control Knob
                                        Figure 5.31 (a)
                     Fiber and Delivery Key fitted to Console Front Panel
LightLas 532  Operator's Manual         Rev. No 01                         Page 82 of 115
                                                                            Light Aperture
                                                                            Setting Control
 Aiming spot
 light up/down
                           Figure 5.31 (b) LIO Intensity Control Knob
          5.    Verify the spot size or zoom system is accordingly (from smallest to
                largest size)
          6.    Ensure the different light aperture setting is also functioned accordingly
                (refer to fig. 5.31b )
          7.    Ensure aiming spot light is able to tilt in up/down position (refer to fig.
                5.31b )
5.5.2.1   Endoprobes
The Endoprobes are sterilized single use devices so it is not possible to do any testing
of them at installation time. It is recommended that if the doctor is to use
Endoprobes that one unit be used as a reference for checking the Console operation
and for Calibration testing.
LightLas 532  Operator's Manual          Rev. No 01                         Page 83 of 115
Installation Record Sheet
Model: LightLas 532                         Console Serial Number: _________________
LIO Serial Number: _____________            Slitlamp LDU Serial Number: ______________
                                            Safety Filter Serial Number: _______________
1.   System Setup                                                           ( Tick for OK )
     1.1 All parts received and checked OK.                                            
     1.2 No damage to instrument packaging.                                            
     1.3 Assemble Slitlamp Delivery Unit to Laser Console.                             
     1.4 Adjust cables then attach cable clamps etc.                                   
     1.5 Plug in cables to Laser Console.                                              
     1.6 Attach mains power cable.                                                     
     1.7 Attach Chinrest to Slitlamp if not yet fitted.                                
     1.8 Finish System assembly.                                                       
2.   Slitlamp Checks
     2.1 Illumination Lamp Controls OK.                                                
     2.2 4 filter wheel settings check OK.                                             
     2.3 With Slit fully open 5 Aperture settings OK.                                  
     2.4 With Large Aperture Set, Slit fully open get full circular spot.              
     2.5 Slit is fully adjustable to closed position.                                  
     2.6 When slit is closed there is no Illumination showing.                         
                                                     o
     2.7 Set narrow slit and check slit rotation + 90 around vertical.                 
     2.8 Load the target rod and set up the correct individual's ocular.                
     2.9 Check that eyepieces fit firmly into binoculars and can be fully adjusted.    
     2.10 Binoculars can be adjusted for interpupillary distance (PD).                 
     2.11 Check Slitlamp movements with joystick:
             Vertical adjustment range OK.                                             
               Sideways adjustment range OK.                                           
               Forward adjustment range OK.                                            
             Movements should be smooth.                                               
     2.12 Illumination Tower and Binocular arm can be swung
          from side to side OK.                                                        
     2.13 The replacement Illumination Tower is fitted to the Zeiss SL130              
           (If applicable).
LightLas 532  Operator's Manual          Rev. No 01                         Page 84 of 115
3.   Chinrest checks
     3.1 Chinrest is not loose in anyway.                                                   
     3.2 Chinrest height is adjustable up / down and movement is smooth.                    
     3.3 Fixation lamp is operating OK.                                                     
     3.4 Fixation lamp can be rotated from side to side OK.                                 
     3.5 Handles are fixed firmly to posts.                                                 
4. Laser System Checks
     4.1 Laser Power ON is indicated by Display LEDs being ON.                              
     4.2 Laser System does self-checks at Start up.                                         
     4.3 Confirm that no Error messages are displayed.                                      
     4.4 Confirm that the correct Delivery System indicator is shown on
         the Remote Control for each of the Delivery keys.                                  
     4.5 Check and inspect that the Laser Safety Filters are assembled into the
         Doctor viewing path for all LDUs.                                                 
     4.6 The Laser System power shows ZERO until the power adjust knob is
         turned and when Power is adjusted this display should change to
         indicateindicate the new power setting.                                            
     4.7 All Display Panel controls, switches and displays are functioning.                 
     4.8 The Aiming beam is visible and intensity is adjustable.                            
5.   Laser Delivery System Checks
     5.1 Check the Aiming beam quality output from the Delivery fiber.                      
     5.2 For the Slitlamp Delivery verify the Doctor Safety filter is
         installed in the Doctors viewing path.                                             
     5.3 If a Moving Safety filter is installed verify that it locates into the
         viewing path whenever the footswitch is pressed.                                   
     5.4 Laser beam aligned OK to Slitlamp focus plane and illumination.                    
     5.5 Micromanipulator operates smoothly and adjusts Laser beam evenly
         within the Slitlamp Illumination spot (If applicable).                             
     5.6 Perform the Power meter check and calibration procedure.                           
     5.7 Aiming beam output is clear from LIO and is in center of illumination              
     5.8 All Binocular Indirect controls function OK including:
          5.8.1 Apertures are all selectable for the LIO.                                   
          5.8.2 LIO Different Filters can be selected.                                      
          5.8.3 LIO Illumination spot adjuster moves spot up and down.                      
          5.8.4 LIO Brightness control on Console varies brightness OK.                     
          5.8.5 Output from Endoprobe is circular and a clear spot.                         
LightLas 532  Operator's Manual          Rev. No 01                              Page 85 of 115
Installers Name : ______________________          Date: __________________
Distributor Name: ______________________          Date: __________________
Customer Name : ______________________            Date: __________________
(Send this Installation Report to the Manufacturer immediately.)
LightLas 532  Operator's Manual    Rev. No 01                      Page 86 of 115
Section 6                      CLINICAL USE
The LightLas 532 is an Ophthalmic Laser intended to coagulate or burn structures
within the patients eye as a surgical treatment for the condition that the patient
suffers from. During the surgical treatment, the Laser energy is delivered directly on
to the patients eye tissue and thereby modifies the eye structure as required by the
doctor.
The LightLas 532 Green Laser is used for performing the following clinical procedures:
             Retinal Photocoagulation
             Pan Retinal Photocoagulation
             Endo-photocoagulation
             Macular Treatments
             Laser Trabeculoplasty
Retinal, Pan Retinal photocoagulation and Endo-photocoagulation are treatments
that involve the destruction of neovascular complexes for destroying areas of
microinfarction or capillary closure.
The Retinal photocoagulation treatment, it can use the Slitlamp Delivery unit. As for
the Pan retinal photocoagulation treatment it can use either the LIO or the Slitlamp
Delivery units. Endo-photocoagulation is performed using the Endoprobes and
should be practiced in a sterile environment.
Macular treatments involve the destruction of leaking vessels in the macular and
paramacular regions in order to produce a chorioretinal adhesion that can resist
ongoing vitreoretinal traction. This treatment is performed using the Slitlamp
Delivery unit.
Laser Trabeculoplasy is the photocoagulation of the trabecular meshwork to create
apertures and thereby increase the flow of the aqueous humor in order to treat
open-angle glaucoma. This treatment is performed using the Slitlamp Delivery unit
The following warnings are typical of all Ophthalmic Green Laser products when used
to perform the surgical procedures as listed above. The warnings are presented
according to the type of Laser Delivery unit used as the warnings in some case are
related to the means of delivery.
LightLas 532  Operator's Manual      Rev. No 01                        Page 87 of 115
6.1 Different types of LDUs Indication / Contraindication Use
There are three different types of delivery system such as, Slitlamp Delivery unit, LIO
and Endoprobes. They are explained in great detailed for their specific indication and
countraindication uses as follows.
6.1.1 Slitlamp Delivery Unit
The Slitlamp Delivery unit allows the treatment of many Retinal conditions and
Glaucoma while still being able to use all the standard diagnostic functions of the
Slitlamp to which it is fitted.
     Indications for use:
      Proliferative and non-proliferative diabetic retinopathy
      Retinal tears and detachments
      Lattice degeneration
      Laser trabeculoplasty in glaucoma treatment
     Contraindications for use:
       Opaque cornea or lens, corneal edema, or blood in the vitreous humor that
        interferes with the treatment by scattering the beam
      Albino patients or eyes that have no pigmentation.
     Additional Contraindications for use in trabeculoplasty:
         Aphakic eye with vitreous in the anterior chamber
         Neovascular glaucoma
         Glaucoma caused by congenital abnormalities of the angle
         Glaucoma secondary to active uveitis
         Less than 90 of open angle or extensive low-lying peripheral anterior
          synechiae present around the circumference of the angle
6.1.2 Laser Indirect Ophthalmoscope (LIO)
The Laser Indirect Ophthalmoscope allows for the treatment of panretinal disorders
and adds the capability of transpupillary retinal photocoagulation to the diagnostic
indirect ophthalmoscope. Use of the LIO enables delivery of the laser to pathologies
in the far periphery of the retina and for treatment of supine patients.
     Indications for use:
      Proliferative and nonproliferative diabetic retinopathy with pathology
       outside the arcades
      Retinal tears
      Lattice degeneration
LightLas 532  Operator's Manual     Rev. No 01                          Page 88 of 115
     Localized retinal detachments
     Any eye requiring laser treatment out to the ora serrata
     Delivering laser treatment through small pupils or to eyes with semi-opaque
        focal lenses
    Contraindications for use:
         Treatment sites close to the macula, within the arcades or where precise
          positioning of the Laser is not possible, should not be attempted
         Opaque cornea or lens, or blood in the vitreous humor that interferes with
          the Laser delivery to the tissue requiring treatment by scattering the beam
         Do not treat albino patients that have no pigmentation
6.1.3 Endoprobe devices
The Endoprobes are typically used during Vitrectomy to perform
endophotocoagulation procedures such as sealing retinal holes during a retinal
detachment procedure or to perform panretinal photocoagulation (PRP) in the
treatment of diabetic retinopathy
The Endoprobe is a blunt intraocular needle fitted to a handle and connected to the
Laser unit by an optical fiber. The Red aiming beam is transmitted through the fiber
and allows clear identification of the position and size of the Laser spot.
The Endoprobes are used in a sterile environment and the doctor will observe the eye
through an Operating Microscope. A doctor safety filter must be fitted to the
operating microscope between the Binoculars and the Microscope. The correct
wavelength safety filter must be used to ensure for the safety of doctors eyes.
The Endoprobes are sterilized and single use devices. Their performance can degrade
which possible cause the delivered power decreased due to the transmission losses.
A spare Endoprobe should be kept available for any situations where the Endoprobe
is not performing satisfactorily.
     Indications for use:
      During vitreous surgery to produce a chorioretinal scar around retinal breaks
       or retinal sites
      To perform PRP in proliferative diabetic retinopathy
      To perform intraoperative PRP on a scleral buckle
      To perform intraoperative PRP around focal neovascularization
    Contraindications for use:
         Do not treat albino patients, or eyes that have no pigmentation
LightLas 532  Operator's Manual      Rev. No 01                            Page 89 of 115
6.2 General Warnings
    Doctors should ensure they have extended training before attempting to carry
     out any of the indicated procedures. Doctors will take full responsibility for the
     setting of the Laser unit operating characteristics, techniques and methods used
     during treatment. They must use their own clinical judgment in determining all
     aspects of the treatment carried out.
    For all type of Delivery units always ensure that the power levels are not set too
     high at initially.
    Always set the power levels according to the tissue effects. Remember that
     highly vascularized and pigmented tissue will require less power than lightly
     pigmented.
     The Aiming beam and Green laser beams are coaxial and if there is any distortion
     to one of them then the other may also be distorted and this can lead to
     inconsistent tissue effects and clinically unsatisfactory results.
    By reducing the spot size by half will increase the power density by a factor of
     four so be very careful not to deliver too much power to the site.
    If the delivery of the Laser does not produce satisfactory tissue effect then
     increase the pulse duration first then the power level. The aim is to produce a
     grey-white burn.
    Any assistant personnel in the treatment room should always wear appropriate
     laser safety glasses suitable for the 532nm wavelength laser while the Laser unit
     is in use.
    Outside the treatment room should be placed Laser warning signs or any
     appropriate warning signs for the country the Laser is being used in. Generally
     the warning signs should state minimum as: Danger/ Caution Laser Radiation,
     avoid eye or skin exposure to direct or scattered laser radiation.
    The laser can coagulate blood vessels up to 1.5mm in diameter. For larger
     diameter vessels coagulation may be difficult so other means such as
     electrocautery may be needed.
    When treating a patients eye, ensure that untreated eye should cover with
     protective shield from the unwanted laser reflection that can lead to irreversible
     eye damage.
    Avoid directly firing the Laser onto the flammable liquids or gases
    Avoid any wet condition near console or footswitch although footswitch is rated
     IPX8 but still not recommend use in the wet condition to avoid the electrical
     hazards.
LightLas 532  Operator's Manual      Rev. No 01                           Page 90 of 115
    Any precaution measured should be taken during any surgical process. All
     personnel should always wear the protective gears such as, gown, cap, mask,
     latex gloves, and safety goggles.
     Caution - Laser plume may contain viable tissue particulates
    When positioning the Laser for treatment always keep the Aiming beam in a
     good focus so that the resultant tissue effect is clinically satisfactory.
    The beam divergence of the Laser beam from the Endoprobes is higher in air
     than in a fluid medium so when using the Endoprobes in air a higher power
     setting will be required to get an equivalent burn as seen on the retina at a given
     distance.
    When using the LIO always ensure that the headpiece is adjusted to be firmly fit
     to the doctors head so that good control is always maintained over the beam
     positioning. The Illumination Lamp housing can get warm but this is normal.
    When using any Laser Contact Lens in treatments, it is essential that they are
     effective and suitable for the procedure with the LightLas 532 Laser. Due to the
     individual len coating can affect the treatment performance quality which may
     result in poor treatment.
    The optical fibers that connect from the any/all Laser Delivery units to the Laser
     Console must always be treated with care. Never try to bend the fibers into loops
     smaller than 200mm in diameter instead just leave them loose or draped over a
     suitable surface. Never allow a fiber to run along the floor or to be in walkways
     where they could be stepped on or crushed with a trolley wheel. Also ensure
     that the fiber ends are kept covered whenever they are not inserted in the Laser
     unit so they remain clean which will extend their lifetime. Avoid touching the
     fiber ends as this may leave deposits on them, which can cause damage when
     the laser is fired into the fiber.
LightLas 532  Operator's Manual      Rev. No 01                          Page 91 of 115
6.3 Possible side-effect or adverse reactions
During or following surgical treatment with the LightLas 532 Green Laser there are
some potential effects or reactions that should be considered. They are similar to
any other surgical procedure and include:
    Pain: this is generally minimal but dependent on the treatment performed.
    Sepsis: care should always be taken to ensure that possible infection risks are
     minimized.
    Bleeding: post-operative bleeding must be considered and the patient should be
     observed and evaluation made for each on an individual basis.
    Perforation: this is more likely to occur when using the Endoprobes so particular
     care is required. In particular it is important not to bring the end of the probe
     closer to the tissue whilst firing the Laser.
    Intraocular pressure: the IOL pressure can increase as a result of the Laser
     treatment so the patient should be monitored and treated accordingly where
     this is a potential issue.
    Venous Pressure: patients should be cautioned against performing any activity
     that could increase their venous pressure in their head or eyes. Avoid rubbing
     their eyes, blowing their nose and prolonged sneezing or coughing. The head
     should be slightly elevated during sleep, while recovering from the treatment
For the LightLas 532 Green Laser several key safety issues to consider are:
    All laser treatment indications and contraindications are well documented and
     readily available for the doctors to reference.
    There is a long history already for the various treatments when using a Green
     Laser, so all possible side effects and adverse reactions are well understood.
    The doctor should always ensure they are adequately trained to perform the
     Laser procedures in LightLas 532 Green Laser system.
LightLas 532  Operator's Manual     Rev. No 01                         Page 92 of 115
 Section 7                         MAINTENANCE
The LightLas 532 Photocoagulator Laser has been designed to require minimal
maintenance. There are several simple routine procedures that are to be carried out
by the operator (see 7.2) but aside of these there are no operator maintenance
requirements.
The manufacturer however does recommend that the LightLas 532 be serviced by an
authorized service agent every 12 months. During this Preventative Maintenance (PM)
service visit the Laser System will be Calibrated and Aligned and the general
operating function confirmed.
It is a requirement that on an annual basis (every 12 months) the LightLas 532 has
the Power meter calibrated to a known calibrated meter and have its earth leakage
current and earth resistance measured according to EN60601-1. These procedures
can only be performed by an authorized service agent of the manufacturer.
If at any time you have concerns about any aspect of the Operation / Calibration or
Alignment of the Laser System you are urged to contact the authorized
representative or the manufacturer in order to decide on a suitable course of action.
Refer to Section 9 of this Manual for particular National requirements of EU
Countries.
7.1       Operator / User Maintenance
The following procedures are those that the manufacturer recommends that the
operator of the Laser System perform routinely. The operator or service person must
always take care not to expose yourself to hazardous laser radiation when performing
any of the maintenance procedures. Always wear safety glasses if operating the laser.
1. Cleaning the external surfaces of the Laser
To clean the outside of the LightLas 532 console, wipe over using a damp (but not
dripping) cloth or use a mild cleaning agent. Do not use any solvents or do not spray or
pour any cleaning agents directly on the equipment. Use a dry cloth afterwards or allow
to air dry.
This procedure should be carried out as often as required but at least every 3 months.
Avoid touching the optical parts, as there is a specific procedure to clean them.
When the Laser System is not in use keep it covered using the Dust Cover.
LightLas 532  Operator's Manual        Rev. No 01                           Page 93 of 115
2. Cleaning the Optics
The optical surfaces of the Laser System are; the objective lens, the illumination tower
prism, the eyepieces and any other Slitlamp accessory that may have been purchased.
The process for cleaning all these optical surfaces is the same.
Moisten one end of a cotton tip (Q-tip) or a folded lens tissue (Kodak or similar) with
100% Methanol or Ethanol and then gently wipe across the optic. Use one Q-tip or tissue
per wipe then discard and repeat with a new one until the optic surface is totally clean.
Never wipe an optic with a dry Q-tip or tissue, as this will scratch the glass.
7.2       Laser Beam Alignment Check
The Laser performance can deteriorate if the optics are not clean. It will depend on the
environment that the Laser System is used in how often the optics should be cleaned
however the optical surfaces should be cleaned at least every three months. To check
the alignment of the LightLas 532 Treatment Laser beam to the Aiming beam
procedure is detailed in the Installation procedure that can be found in Section 5 of
this manual. The beams should always be centered together because they are
delivered together by an optical fiber.
At the Target site (focal plane) it is also necessary to make sure the beams are
centered and focused in the center of the Illuminated spot. There are adjustment
screws for the Slitlamp LDU and for the LIO the Optics housing can be rotated to
adjust the horizontal plane and a mirror adjustment for the vertical plane.
 There are no adjustments for the Endoprobes.
  For all LDUs it is important that the delivered Laser beams are round in shape as
 this then means the alignment of the fiber to the internal Laser cavity is correct. If
 this alignment is bad then the fiber may become damaged particularly at high power
 settings.
 If the output beam from the fiber is checked and whether with the Aiming beam or
 the Treatment beam it is anything other than a round spot then there is a strong
 possibility that the alignment of the Laser beams into the fiber has changed or the
 fiber is damaged in some way. In either case it is important to get the alignment
 checked by a Service person to verify if the system is OK to be used. If the output
 beam looks OK with another fiber then it is most likely that the fiber is damaged and
 the Laser alignment in the Console is OK.
LightLas 532  Operator's Manual         Rev. No 01                               Page 94 of 115
7.3       System Output Power Checking Procedure
This system output power checking procedures are intended to ensure the LightLas
532 system performance validation and it must be carried out by an authorized and
trained service agent. Therefore if you believe the Laser System is out of
specification or requires extended Calibration procedures you should have the
system checkout and verified by authorized and trained service prior to use the
equipment.
More detailed of these procedures are explained in the Service Repair Manual refer
to calibration section.
The procedure for checking the System Output Power is the same for the
Endoprobes, Slitlamp and LIO delivery units and the detailed procedures are listed
below:
Equipment Required:
             - Power meter (Coherent Labmaster, Fieldmaster or Newport) CW 2W +/-
               0.1W
             - Safety glasses OD4+ / 532nm
Procedures:
   1. Ensure to plug the correct delivery key to the Laser Console as the front panel
      indicator will show the correct unit is attached.
   2. Set the remote controls panel setting to 50% duty cycle which the pulse interval
      and pulse duration both set to 0.05 sec.
   3. Set the system to Treat Mode and aim the output Aiming beam at the center of
      the Power Meter detector with the spot size at around 5mm diameter or 50% of
      the active detector area.
   4. Set the Laser Power to levels of 100, 500, 1000 and 1500 mw and for each
      setting fire the laser using the footswitch and note the External Power Meter
      reading. For the Integrated Slitlamp Delivery the output power should be
      checked at both the 200 and 1000 spot size settings and for the Attachment
      Delivery Unit use the 100 and 500 spot sizes.
   Note: For the Slitlamp Delivery units ensure that the Slitlamp Illumination tower is
         pushed to one side so that it cannot block any of the Laser beams.
   5. Ensure the reading multiply it by 2 (X2) to get the true power level as it is being
      fired at 50% duty cycle. Record the X2 reading for each power setting on the
      System Output Power Record Sheet.
   6. Validate the measured power readings (X2) must be within +/-20% of the set
      power for the system to be passed.
LightLas 532  Operator's Manual      Rev. No 01                          Page 95 of 115
   7. Ensure the readings fall within the +/-20% tolerance if not, then recheck the
      system and make sure the External Meter is set up properly and the fiber has no
      sharp bends or damage to it. Replace another fiber to validate it because the
      damaged fiber can introduce significant power losses.
   8. If the checking data definitely out of tolerance then the manufacturer or
      authorized distributor must be contacted and the Laser System calibration
      adjusted according to the procedure in the Service manual.
   9. Be sure to complete the record sheet and keep the copy in the system records.
  10. This system throughput check should be performed at least once a year to
      ensure the o/p power performance is within the specified accuracy.
                            System Output Power Record Sheet
Power Meter Model:____________ Serial Number:________________
Checked by:__________________________ Date:_________________
Delivery Unit type:____________________________________________
   Displayed Power           Meter Reading      Reading X2    Min. / Max.    Pass / Fail
        100 mw                                               80 / 120 mw
        500 mw                                               400 / 600 mw
        1000 mw                                              800/1200 mw
        1500 mw                                              1200/1800mw
LightLas 532  Operator's Manual        Rev. No 01                      Page 96 of 115
Section 8                          TROUBLESHOOTING
The Lightlas system 532 is designed to have a service free part as possible. It is
divided into three major sections such as, Symptom, Warning, and Error code.
8.1 Symptom
A completed listing of Lightlas system 532 symptoms or warnings and along with the
suggested corrective action is explained as following:
Symptom(s)                         Cause(s)                 Remedy action(s)
No power / no display              -Power failure           -Check the power source or
                                                            connector
                                   -Remote control panel
                                   connector not            -Check the power fuses
                                   connected                -Check the emergency button is
                                                            outward ON position
                                                            -If the problem persists, call the
                                                            authorized service or
                                                            manufacturer for further
                                                            assistance
No lamp illumination               -No power to the lamp    -Check the lamp voltage
(SD only)                                                   distribution (+12)
                                   -Lamp is burned out
                                                            -Check the lamp integrity
                                                            -Check that there is no dust and/or
                                                            fingerprint on the bulb
                                                            -Call the authorized service or
                                                            agent for assistance
No aiming beam (SD                 -Aiming beam intensity   -Reboot the system
only)                              needs to be calibrated   -If the problem persists, call the
                                   -Aiming beam electric    authorized service or
                                   circuit failure          manufacturer for further
                                                            assistance
LightLas 532  Operator's Manual              Rev. No 01                         Page 97 of 115
No or low output of the -Fiber is damage                     -Check the fiber integrity by
Green laser beam                                             replacing a new one
                        -Treat mode is not
                        activated                            -Activate the Treat mode
                                   -Output power not         -Selected the specified power
                                   selected                 -If the problem persists, call the
                                   -Laser cavity decayed    authorized service or
                                   -Electronics malfunction manufacturer for further
                                                            assistance
LightLas 532  Operator's Manual              Rev. No 01                         Page 98 of 115
8.2 Warning
A completed listing of Lightlas system 532 warnings and the suggested corrective
action are detailed as following:
                                                                          Warning Message
                                                                              Correction Action
LightLas 532  Operator's Manual   Rev. No 01                      Page 99 of 115
LightLas 532  Operator's Manual   Rev. No 01   Page 100 of 115
LightLas 532  Operator's Manual   Rev. No 01   Page 101 of 115
8.3 Error Codes
If during normal operation of the Laser System or during the Startup or Special
Modes, if a fault, error, or warning condition is found by the microprocessor then the
Laser System will go to the Standby mode and an error or warning message will be
shown on the Display Panel. The Laser System cannot be operated when an error
message is displayed.
Call authorized service if an error message is regularly shown on the system display.
Note: Under no circumstances should unauthorized or untrained personnel attempt
      repairs. Refer to the warranty conditions for further details.
The error codes of the Lightlas system are usually shown in 3-digits or 4 digits codes
(refer to fig. 8.1).
                                                                              Failure Types
                                                                                Failure Description
                                                                                Remedy Action(s)
                                                                                 Failure Codes
                             Figure 8.1 Sample of error code display
LightLas 532  Operator's Manual          Rev. No 01                    Page 102 of 115
A complete listing of the Lightlas 532 error codes along with the suggested corrective
actions are shown below:
Error code                  Cause(s) / Description         Remedy Action(s)
Err 500 - ROM               -System failed to pass the     -Reboot the system
                            software integrity test        -If the problem persisted, call the
                                                           authorized service or manufacturer
                                                           for further assistance
Err 501 - Shutter           -Shutter failed to open or     -Reboot the system
Failure                     close                          -If the problem persisted, call the
                                                           authorized service or manufacturer
                                                           for further assistance
Err 502 - Laser             -Laser diode current is        -Call the authorized service or
Diode Current Too           out of range or over the       manufacturer for further assistance
High                        limits
Err 503 - Aiming            -Aiming laser beam failure -Call the authorized service or
Laser Failure               or the laser intensity is > manufacturer for further assistance
                            1mW
Err 5041 - Laser            -Ambient temp. is too high  -Reboot the system
Diode Temperature           or low which causes the
                                                           -If the problem persisted, call the
Out of Tolerance +/-        laser laser temp. TEC unable
                                                           authorized service or manufacturer
2.5C                        to reach the stable or
                                                           for further assistance
                            preset value within 5 mins.
Err 5042 - Laser            -Laser sensor failure          -Power off ; call the authorized
Sensor Failure              (opened or shorted             service or manufacturer for further
                            sensor)                        assistance
Err 5043 - Cavity           -Cavity Temperature            -Reboot the system
Temperature Out of          sensor can not reach to        -If the problem persisted, call the
Tolerance +/- 2.5C          the preset +/- 2.5C            authorized service or manufacturer
                                                           for further assistance
Err 5044 - Cavity           -Cavity temp. sensor           -Call the authorized service or
Temperature                  failure or the sensor is      manufacturer for further assistance
Sensor Failure               open or shorted circuit
Err 5051 - Remote           -No communication              -Reboot the system
Communication               between remote and the         -If the problem persisted, call the
Error                       laser console within the       authorized service or manufacturer
                            time of frame of 300ms         for further assistance
LightLas 532  Operator's Manual           Rev. No 01                           Page 103 of 115
Err 5052 - Remote           -Timer in remote stopped      -Reboot the system
Time Up Error               running for 1ms               -If the problem persisted, call the
                                                          authorized service or manufacturer
                                                          for further assistance
Err 5053 - Remote           -mismatched code in the       -Reboot the system
ROM Error                   remote software when          -If the problem persisted, call the
                            booting up                    authorized service or manufacturer
                                                          for further assistance
Err 5054 - Remote           -Can not configure laser      -Reboot the system
Configuration Error         console operation             -If the problem persisted, call the
                                                          authorized service or manufacturer
                                                          for further assistance
Err 506 - Delivery          -Slitlamp safety filter       -Check the safety filter moving
System Shutter              could not close within 1s     operation
Failure                                                   -Reboot the system or call the
                                                          authorized service or manufacturer
                                                          for further assistance
Err 5071 - System           -The system stop running      -Reboot the system
Time Up Error               for 1ms                       -Call the authorized service or
                                                          manufacturer for further assistance
Err5072-                    -No communication             -Reboot the system
Communication               between the panel             -Call the authorized service or
Error                       control and console CPU       manufacturer for further assistance
Err 508 - Calibration       -The system is                -Call the authorized service or
Error                       uncalibrated                  manufacturer for further assistance
Err 510 - Watchdog          -System watchdog flag         -Reboot the system
Error                                                     -Call the authorized service or
                                                          manufacturer for further assistance
Err 5121 - Power Too        -The measured o/p laser   -Call the authorized service or
High                        power is exceeded by 20% manufacturer for further assistance
                            of the preset power value
Err 5122 - Power Too -The measured o/p laser              -Call the authorized service or
Low                  power is under by 30% of             manufacturer for further assistance
                     the preset power value
LightLas 532  Operator's Manual             Rev. No 01                        Page 104 of 115
Err 5123 - No Power         -The measured o/p laser       -Call the authorized service or
or Zero Power               power is less than 10mW       manufacturer for further assistance
                            while the duty cycle is set
                            off
Err 5124 - Power            -Power photodiode             -Call the authorized service or
Photodiode Sensor           sensor failure                manufacturer for further assistance
Error
Err 513 - System            -The system stop running      -Call the authorized service or
Error                       for 1ms                       manufacturer for further assistance
LightLas 532  Operator's Manual           Rev. No 01                         Page 105 of 115
 Section 9                     European Community Issues
    1. Declaration of Conformity
       LightMed Corporation declares that the LightLas 532 Ophthalmic Frequency
       Doubled YAG Laser System complies to the requirements of the MDD
       Regulation and meets, (where applicable), the Essential Requirements of
       Council Directive 93/42/EEC as amer pertaining to Medical Devices.
       National Requirements of EU Countries may not have been considered but
       will be implemented if and when required by the local Distributors. This
       includes local language translations of relative Instructions for use and
       labeling.
         We hereby notify appointment of Medical Device Safety Service GmbH
         Schiffgraben 41, 30175 Hannover, Germany to act as the European Authorized
         Representative as defined in Article 1,  2(g) of the Directive 98/79/EEC
         The following standards have been applied and tested.
              IEC60601-1
              IEC60601-1-1
              IEC60601-1-2
              IEC60601-1-4
              IEC60601-2-22
              IEC60825-1
              ISO14971
    2. Warranty
       The LightLas 532 Frequency Doubled YAG Laser conforms to the requirements
       of the MDD (93/42/EEC as amended by 2007/47/EC) and thereby in the EU
       Countries the Warranty as specified in the applicable regulations will apply.
       Your local Distributor will be able to confirm the details.
    3. Specific German Requirements/ Nationale Anforderungen in Deutschland
       Since 01.01.1993 the User has had responsibility for accident prevention for
       laser equipment. According to section 5 of this rule the laser equipment
       manufacturer has to be registered by a responsible Notified authority and
       reviewed by an expert laser agent, in according to Section 6.
         The laser Equipment has to be verified by Technical Safety Inspection annually
         for the following items. The test results are to be recorded and kept in a
         devices appendix.
LightLas 532  Operator's Manual      Rev. No 01                        Page 106 of 115
                1. Function Test including:
                    Measuring of laser output
                    Laser-Power-Off-Testing
                    Long-distance remote interlocking
                    Fiber optic cable
               2. Measuring of electrical leakage currents
                    According to DIN VDE 0751, Part 1, 9 (with 230 VAC/50 Hz max.
                        500uA)
               3. Measurement of PE resistance (Rated value: < 0.1 Ohm in appliance
                   inlet plug < 0.2 Ohm in power plug)
          Der Anwender wird hiermit auf seine Pflichten aus der
          Unfallverhtungvordchrift LASERSTRAHLUNG (VBG93) in der Fassumg vom
          01.01.1993 hingewiesen. Hierzu: Durchfhrungsanweisung vom Oktober 1995.
          Nach #5 dieser Vorschrift muss der Betrieb eiens Lasers bei den zustndigen
          Behrden       angemeldet,      und     nach     #6    ein     sachkundiger
          Laserchutzbeauftragter schriftlich bestellt werden.
          Das Lasergert muss einmal jhrlich einer sicherheitstechnischen Kontrolle
          unterzogen werden (MPBetreibV,#6)
          1. Funktionsprfung
                  a. Messung der Laserleistung
                  b. Laser-Not-Aus-Taster
                  c. Fernverriegelung
                  d. Lichtleiter
          2. Messung des Erdableitstroms
                  a. NachDIN VDE 0751,Teil 1, Schaltbild 9 (bei 230 VAC/50Hz max.
                     500A)
          3. Messung des Schutzleiterwiderstands
                  a. (Sollwert: <0.1 Ohm am Gertestecker <0.2 Ohm am Netzstecker)
 ber das Ergebnis der Prfung ist eine Bescheinigung auszustellen, die bei den
Gerteunterlagen (Medizinproduktebuch) aufbewahrt werden muss.
LightLas 532  Operator's Manual      Rev. No 01                      Page 107 of 115
Section 10                        EMC Test Tables
  Guidance and manufacturers declaration
        electromagnetic emissions
LightLas 532 is intended for use in the electromagnetic environment specified below. The customer or the user of
the LightLas 532 should assure that it is used in such an environment.
Emissions test                  Compliance         Electromagnetic environment  guidance
                                                    LightLas 532 uses RF energy only for its internal function.
RF emissions
                                Group 1            Therefore, its RF emissions are very low and are not likely to
CISPR 11
                                                   cause any interference in nearby electronic equipment.
RF emissions
                                Class B
CISPR 11
                                                   LightLas 532 is suitable for use in all establishments, including
Harmonic emissions
                                Class A            domestic establishments and those directly connected to the
IEC 61000-3-2
                                                   public low-voltage power supply network that supplies
Voltage fluctuations/
                                                   buildings used for domestic purposes.
flicker emissions               Complies
IEC 61000-3-3
                                   Recommended separation distances between
                        portable and mobile RF communications equipment and LightLas 532
LightLas 532 is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of LightLas 532 can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and
LightLas 532 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
LightLas 532  Operator's Manual                   Rev. No 01                                     Page 108 of 115
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.
LightLas 532  Operator's Manual                 Rev. No 01                                 Page 109 of 115
  Guidance and manufacturers declaration
         electromagnetic immunity
LightLas 532 is intended for use in the electromagnetic environment specified below. The customer or the user of
LightLas 532 should assure that it is used in such an environment.
Immunity test          IEC 60601                  Compliance level           Electromagnetic environment 
                       test level                                            guidance
Electrostatic          6 kV contact              6 kV contact              Floors should be wood, concrete or
discharge (ESD)        8 kV air                  8 kV air                  ceramic tile. If floors are covered with
IEC 61000-4-2                                                                synthetic 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
IEC 61000-4-4          1 kV for input/output     1 kV for input/output     environment.
                       lines                      lines
Surge                  1 kV line(s) to line(s)   1 kV line(s) to line(s)   Mains power quality should be that of a
IEC 61000-4-5          2 kV line(s) to earth     2 kV line(s) to earth     typical commercial or hospital
                                                                             environment.
interruptions and      <5 % UT                    <5 % UT                    Mains power quality should be that of a
voltage variations     (>95 % dip in UT)          (>95 % dip in UT)          typical commercial or hospital
on power supply        for 0,5 cycle              for 0,5 cycle              environment. If the user of LightLas 532
input lines            40 % UT                    40 % UT                    requires continued operation during
                       (60 % dip in UT)           (60 % dip in UT)           power
IEC 61000-4-11         for 5 cycles               for 5 cycles               mains interruptions, it is recommended
                       70 % UT                    70 % UT                    that LightLas 532 be powered from an
                       (30 % dip in UT)           (30 % dip in UT)           uninterruptible power supply or a
                       for 25 cycles              for 25 cycles              battery.
                       <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
(50/60 Hz)             3 A/m                      3 A/m                      be at levels characteristic of a typical
magnetic field                                                               location in a typical commercial or
IEC 61000-4-8                                                                hospital environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.
LightLas 532  Operator's Manual                    Rev. No 01                                       Page 110 of 115
 Guidance and manufacturers declaration 
        electromagnetic immunity
LightLas 532 is intended for use in the electromagnetic environment specified below. The customer or the user of
LightLas 532 should assure that it is used in such an environment.
Immunity
                 IEC 60601 test level     Compliance level                 Electromagnetic environment  guidance
test
                                                                 Portable and mobile RF communications equipment
                                                                 should be used no closer to any part of LightLas 532
                                                                 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
                                          3 V/m                  distance in metres (m).
                                                                 Field strengths from fixed RF transmitters, as
                                                                 determined by an electromagnetic site survey,a should
                                                                 be less than the compliance level in each frequency
                                                                 range.b
                                                                 Interference may occur in the vicinity of equipment
                                                                 marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
 LightLas 532  Operator's Manual                   Rev. No 01                                       Page 111 of 115
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 LightLas 532 is used exceeds the applicable RF
compliance level above, LightLas 532 should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating LightLas 532.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
 LightLas 532  Operator's Manual                   Rev. No 01                                     Page 112 of 115
APPENDIX I
Optional Accessories
The following accessories can be purchased from the Distributor to use with the
LightLas 532 Photocoagulator Laser Product. The accessories are only available for
customers outside the EU Countries due to the requirements for CE Marking and the
manufacturer not having control over the use of the attachments that are available
and their indications for use.
   Safety glasses OD7+ @ 532nm (CE Marked)                  Part Number 620003
   Fiber for Keeler LIO                                     Part Number 620028
   20D Indirect Laser Lens                                  Part Number 600237
   28D Indirect Laser Lens                                  Part Number 600238
   Slitlamp SL990-2X                                        Part Number 600250
   CSO Beam Splitter                                        Part Number 600018
   Observation tube                                         Part Number 600023
   Endo Probes Straight(20Gages)                            Part Number PD720.10
   Endo Probes Curved (20 Gages)                            Part Number PD720.20
   Endo Probes Curved (23 Gages)                            Part Number PD723.10
   Endo Probes Curved (23 Gages)                            Part Number PD723.20
   Endo Probes Curved (25 Gages)                            Part Number PD725.10
   Endo Probes Curved (25 Gages)                            Part Number PD725.20
   Straight Endo Probes Illuminate                          Part Number PD723.30A
   Curved Endo Probes Illuminate                            Part Number PD723.35A
   Endo Probes Aspirating                                   Part Number PD720.60
The following accessories are designed and manufactured by Lightmed
 Adjustable Headband                                  Part Number YL0621,YL6022
 Motorized Table                                      Part Number TB0016
 Integrated Laser Slitlamp Delivery                   Part Number SD0008
 LIO Delivery on Keeler Pupil                        Part Number LK0001
 Operating Microscope Safety Filter (Manual filter)   Part Number MS0000,MS0001
 Attachment Laser Delivery Unit (Haag Streit style)   Part Number HS006,HS0007
 Attachment Laser Delivery Unit (Zeiss 30SL style)    Part Number ZS0000,ZS0002
 Attachment Laser Delivery Unit
   (LightMed SYL9000)                                  Part Number YG0013,YG0014
 Delivery attachment (adapter) for LightLas
  YAG Truspot                                          Part Number AD0021
 Delivery attachment (adapter) for Haag Streit
  Compatible Truspot                                   Part Number AD0000
LightLas 532  Operator's Manual     Rev. No 01                      Page 113 of 115
 Delivery attachment (adapter) for Zeiss Compatible
  Truspot                                                  Part Number AD0002
 Delivery attachment (adapter) for Haag Streit
  BM900 Truspot                                            Part Number AD0003
The following are spare part accessories:
   Slitlamp Bulb, 6 Volt 20 Watt, Pre-focused with base   Part Number 240012
   Chinrest Papers                                        Part Number 600026
   Footswitch                                             Part Number LCA903
   Delivery Key  Slitlamp                                Part Number SD5100
   Delivery Key  LIO                                     Part Number LI9100
   Delivery Key  Endo                                    Part Number LCA190
   Delivery Fiber (2 meters long)                         Part Number SD5000
   Delivery Fiber without key                             Part Number SD5001
   Delivery Fiber Assembly For LIO (3 meters long)        Part Number LK6000
   Remote Interlock Connector                             Part Number LCA180
Attention: The accessories are passive (do not emit laser radiation) and depend on
the main device (Lightmed LightLas 532).
LightLas 532  Operator's Manual       Rev. No 01                     Page 114 of 115
LightLas 532  Operator's Manual   Rev. No 01   Page 115 of 115