Lightmed LightLas 532/670 Operator's Manual
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Lightmed LightLas 532/670 Operator's Manual

Multi-wavelength pattern scanning system
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Operator Manual
Multi-Wavelength Pattern
Scanning System – LightLas
532 / 670

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Summary of Contents for Lightmed LightLas 532/670

  • Page 1 Operator Manual Multi-Wavelength Pattern Scanning System – LightLas 532 / 670...
  • Page 2 Operator Manual for the Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 Directive 93/42/EEC as amended by 2007/47/EC Doc. No. : DC1800 Rev. No. : Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 – Operators Manual Rev. No 01 Page 1 of 126...
  • Page 3 CAUTIONS - U.S. law restricts this device to sale by or on the order of a physician This Service 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...
  • Page 4 Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 – Operators Manual Rev. No 01 Page 3 of 126...

  • Page 5: Table Of Contents

    Table of Contents Section 1 INTRODUCTION ……………………………………………………………..8 Section 2 SAFETY.………………………………………………………………………9 Product Classifications ….…………………………………………………………... 9 2.2 Warnings and Precautions …………………………………………………………. 10 Optical Hazards ……………………………………………………………………..12 2.3.1 Nominal Ocular Hazard Distance (NOHD) ............ 12 Electrical Hazards ……………………………………………………………………13 Safety Controls and Features ……………………………………………………….14 Product Labeling …………………………………………………………………….18 2.61 Console system ....................
  • Page 6 B. Laser Indirect Ophthalmoscope (Optional) …………………………83 C. Endoprobe (Optional) ………………………………………………86 Integrated System Initialization and Validation …………….……………………..82 A. LCD / Console Validation ……………………………………………..87 B. Console Control Panel and Aiming Intensity Validation ……………87 C . P a t t e r n S c a n C o n t r o l V a l i d a t i o n … … … … … 8 9 D .
  • Page 7 LIST OF DRAWINGS / FIGURES Figure Description Page Safety Controls 2.2(a) Laser Console Labels Laser Console Labels 2.2(b) Integrated Slit lamp LDU with Labels (RH side) 2.4(a) 2.4(b) Integrated Slit lamp LDU with Labels (LH side) LIO LDU with Labels System software start up screen shot System software boot up ok and system is "Standby"...
  • Page 8 Figure Description Page Hang console and plug in all the front panel connections 5.13(a) Console Rear End Connections 5.13(b) Arm rest installed 5.14 Clamp down the LCD Panel Holder in the middle of the gutter 5.15(a) Organize the two control panel cablings and ready to fit the LCD 5.15(b) Complete securing four holding screws behind the LCD panel and 5.15(c)

  • Page 9: Introduction

    Section 1 INTRODUCTION This manual is intended to provide the operator with an overview of the operation and safety requirements for the Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 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.

  • Page 10: Section 2 Safety

    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.

  • Page 11: Warnings And Precautions

     Others MDD 93/42/EEC (as amended by 2007/47/EC) IEC60601-1-4 (1996) + A1(1999) ISO14971 (2007) Warnings and Precautions The following warnings and precautions apply to the Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 Laser System and should be observed by all users at all time: ...

  • Page 12: Optical Hazards

    Delivery Units to the Console to make sure they do not get damaged. 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.

  • Page 13: Nominal Ocular Hazard Distance (Nohd)

    2.3.1 Nominal Ocular Hazard Distance (NOHD) The Nominal Ocular Hazard Distance (NOHD) is the distance between the equipment and a person’s 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.

  • Page 14: Electrical Hazards

    Electrical Hazards The Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 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 Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 photocoagulator laser without an earth-grounded receptacle.

  • Page 15: Safety Controls And Features

    2.5 Safety Controls and Features For the Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 to comply to the various requirements of the standards referred to previously there are a number of Controls and Features that are provided (refer to Figure 2.1). Figure 2.1 Safety Controls and Features Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 –...
  • Page 16 All safety features or controls must be engaged, in order for the system to operate or function properly except audit warning. A full detailed description of these safety features is provided in following: Emergency Stop Switch This switch is functioned as a fast response shutdown of the Laser System in the event of some serious problem occurring.
  • Page 17 delivered to the patient if footswitch is engaged. The System will go back into the STANDBY mode, if it is unoperated for 10 mins or deactivated. Remote Door Interlock Connector This remote door interlock connector is functioned as an engaged key to the system.
  • Page 18 for earth connections and earth leakages.  If the laser system is not used or no controls are operated for 10 minutes the System will go back to the STANDBY mode if it was set into the READY mode.  The Console gives an audible warning whenever the laser is firing. Note: With all these controls and features, the Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 is a very safe instrument when it is used correctly and as indicated in this manual.

  • Page 19: Product Labeling

    A full facsimile of all the safety and control labels is shown in the figures 2.2a-b. Port 2 Port 1 LIGHTMED STOP Delivery MANUFACTURED: Manufactured by LightMed Corporation No1-1, Lane 1, Pao-An Street, Section 3 Shulin Dist., New Taipei City, 23861, TAIWAN EU Authorized Representative EC REP (MDD 93/42/EEC) Medical Device Safety Service GmbH...

  • Page 20: B) Laser Console Labels

    ...displays on screen. Serial Number : Endoprobe Plug User Instructions Manufactured : Manufactured By : ML0000 LightMed Corporation, No.1-1, Lane 1, Pao-An St. Sec. 3, Shulin Dist., New Taipei City, 23861, TAIWAN(R.O.C) TEL : 886-2-2688-1726 FAX : 886-2-2688-5875 E-mail : sales@lightmed.com This device complies to the requirements of 21 CFR 1040.10 and 1040.11,...

  • Page 21: Integrated Slit Lamp Ldu

    IEC60825-1 2007 SD3100-03 DANGER / CAUTION Visible laser radiation when open AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION Manufactured: Lightmed Corporation Safety Filter Model No: OD4@532/670nm Serial No: 0434 Figure 2.4(a) Integrated Slit lamp LDU with labels (RH side) Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 –...

  • Page 22: B) Integrated Slit Lamp Ldu With Labels (Lh Side)

    2.62 Integrated Slit lamp LDU continues... Figure 2.4(b) Integrated Slit lamp LDU with labels (LH side) Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 – Operators Manual Rev. No 01 Page 21 of 126...

  • Page 23: Laser Indirect Ophthalmoscope Ldu

    2.63 Laser Indirect Ophthalmoscope LDU Lightmed Corporation Safety Filter Model No: OD4@532nm/670nm Serial No: Manufactured: DANGER / CAUTION Visible laser radiation when open AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION 0197 0434 Figure 2.5 LIO LDU with labels Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 –...

  • Page 24: Section 3 Product Specifications

    Section 3 PRODUCT SPECIFICATIONS Introduction The following are the System Specifications for the Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 Ophthalmic Laser. There are divided into Console Laser System, Laser Delivery Unit (LDU), and Accessories 3.1.1 Console Laser System General Specification Electrical 100 to 230 Vac.

  • Page 25: Laser Delivery Unit (Ldu)

    Exposure 0.01, 0.02, 0.03, 0.04, 0.05, 0.06, 0.08, 0.1, 0.15 then from0.2 to 3.0s in Duration 0.1 sec. intervals Repeat Selectable from 0.01 to 3.0s and equal to or greater than exposure Interval duration in same discrete steps as duration Micro Pulse Doctor Safety Filter...

  • Page 26: Accessories

    LightLas Truscan Pattern Single, Line, Square (2x2, 3x3, 4x4, 5x5), Macular Arc (single, double, Scanning triple 1/4, 1/2, 3/4), Circle and Triangle – Spot width, density and 360 rotation available for each pattern. 50, 100, 200, 300, 400, 500 m selectable on Zoom assembly of Spot Sizes Delivery unit.

  • Page 27: Cso Sl980 Slit Lamp Specifications

    3.2 CSO SL980 Slit lamp Specifications The following are the Slit lamp Specifications for the CSO SL980 Slit lamps that is accompanied with the Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 Photocoagulator Laser System. The SL980 is a Zeiss clone and uses an illumination source below the viewing path.

  • Page 28: Principles Of Operation

    Section 4 PRINCIPLES OF OPERATION General Description The Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 Laser system is an Ophthalmic Laser suitable for performing the following clinical procedures:  Retinal Photocoagulation  Pan Retinal Photocoagulation  Endo photocoagulation ...
  • Page 29 All the normal functions of a Slit lamp are available to the operator when using the Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 on a Slit lamp unit and when the doctor is using the LIO they will use a Contact Lens of either 20D or 28D.
  • Page 30 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 heat energy which raises the temperature of the tissue being treated producing thermal coagulation of the protein.
  • Page 31 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 LDU’s is the Slit lamp delivery unit. There are many optics in this unit due to the spot size adjustment zoom system so the losses are the greatest.

  • Page 32: System Software Start Up Screen Shot

    this manual). This process usually takes less 5 mins. Figure 4.1 System software start up screen shot Figure 4.2 System software boot up ok and system is "Standby" mode Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 – Operators Manual Rev.
  • Page 33 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 ...
  • Page 34 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”...

  • Page 35: System Software Is Ready To Shutdown

    expected to use the laser system in a clean and controlled environment. When 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).

  • Page 36: Laser Console

    Laser Console All the Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 Photocoagulator’s controls and displays are located either on the console front panel or the rear panel and LCD display control panel (refer to fig. 4.4 - 4.7). A detailed description of each control and display is explained on the next page.
  • Page 37 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 this position, all internal power will be removed. In order for system to restore the power, the switch must be rotated to reset to the on position.
  • Page 38 and once the door opens the circuitry will be opened causing the system to be disabled. At this time, the warning message will show on the LCD control panel display. Once the door shuts the system will go default back to STANDBY mode. By default setting a dummy “Interlock”...

  • Page 39: Lcd Control Panel Display Screen

    LCD Control Panel Display Screen Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 system software features several type of screens, as well as pop-up windows that display on the screen. The screen is divided into two major portions. Left hand side of screen is called the pattern scanning screen and the right hand side is the console screen (refer to fig.

  • Page 40: Console Control Screen

    4.31 Console Control Screen This screen consists of STANDBY, READY, Output Power display, Power control, Duration display, Duration control, Interval display, Interval control, Aiming Intensity display, Aiming Intensity control, LIO Intensity display, LIO Intensity control, Buzzer control, Reset control, Type of LDU display, and Type of Operating Wavelength and Protocol.
  • Page 41 STANDBY Mode Button When this indicator is illuminated, the laser system is in the Standby mode and both of the aiming beam and the laser power can't be delivered to the patient. 2. READY Mode Button When this indicator is illuminated, the Laser System is in the READY mode and both of the aiming beam and the laser power can be delivered to the patient once the footswitch is pressed or activated.
  • Page 42 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.
  • Page 43 16. Type of Delivery System Indicator This indicator will indicate the type is being used. 17. Type of System Wavelength Indicator Button in Port 2 This indicator will indicate the activation of type of wavelength. 18. Type of System Wavelength Indicator Button in Port 1 This indicator will indicate the activation of type of wavelength.

  • Page 44: Pattern Control Screen

    4.32 Pattern Scan Control Screen There are seven different types of pattern scanning photocoagulation. Under this individual pattern type the system offers and features more extensive and variety selection. The parameter selection can be in radius, curvature, and repetition rate. More detailed are explained in the following.
  • Page 45 Single Spot This function can select or activate by touching the screen and button will submerge when it is activated. In this mode the spot could be off the center position when activated. The micro-joystick VR is to control back to its preference position.
  • Page 46 2. Straight Line Pattern It can be selected or activated by touching the screen button and button will submerge when it is activated. The final or pre selection will display in the pattern display area. Available parameter setting can be selected as follows: - Spot size: 100-500μm - Spacing: 1.0-3.0 - Rotation: 0 or 90 degree...
  • Page 47 Square Pattern It can be selected or activated by touching the screen and the final or pre selection type will display in the pattern display area. Its sub selection types are listed below:  2 x 2  3 x 3 ...
  • Page 48 4. Triangles Pattern It can be selected or activated by touching the screen and the final or pre selection type will display in the pattern display area. Available parameter setting can be selected as follows: - Spot size: 100-500μm - Spacing: 1.0-3.0 - Rotation: 0 or 90 degree Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 –...
  • Page 49 Circular Pattern It can be selected or activated by touching the screen and the final or pre selection will display in the patter display area. Its sub selection types are listed below:  Full circle  3/4 circle  1/2 circle ...
  • Page 50 6. Arc Pattern It can be selected or activated by touching the screen and type will display in the pattern display area. Its sub selection types are listed below:  Triple Arc Rings  Double Arc Rings Available parameter setting can be selected as follows: - Spot size: 200-500μm - Spacing: 1.0 - Rotation: 0 to 360 degree...
  • Page 51 Curve Pattern It can be selected or activated by touching the screen and the final or pre selection will display in the patter display area. For this particular configuration, there is no sub selection type available. Available parameter setting can be selected as follows: - Spot size: 200-500μm - Spacing: 1.0-2.0 - Rotation: 0 to 360 degree...
  • Page 52 8. Scanning Speed This button is used as to enhance the pattern scanning speed which allows the user preference. It can be 2x or 3x faster. 9. Pattern Rotation Function This button is used to rotate the pattern and it is located in the mid bottom of the screen.

  • Page 53: Remote Control Panel

    Remote Control Panel Treat Stand By Output Power Duration Mode MicroPulse 532/577 670/810 Interval Port 2 Mode Counter Figure 4.8 Remote Control Panel Breakdown Legend 1. Exposure Duration Display 2. Exposure Duration Setting Switches 3. Repeat Interval Display 4. Repeat Interval Setting Switches Aiming Beam Intensity Indicator Display Aiming Beam Intensity Setting Switches Power Control Adjuster...
  • Page 54 Exposure Duration Display This display shows the exposure duration setting in seconds. Also another function will display the type of error code or warning. 2. 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.
  • Page 55 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. 8. Set Power Display This display will show the set power level and the display will change as the power is adjusted.
  • Page 56 18. Total Laser Counts display This display gives a sum of the total number of Laser shots fired during the laser treatment. Also another function will display the type of error code or warning. 19. Counter Reset Switch Whenever this switch is pressed the total laser shot counter is reset to zero. Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 –...

  • Page 57: Truscan Integrated Into Cso Model Sl980

    Truscan Integrated into CSO model SL980 The controls on the Slit lamp LDU are used to adjust the Laser beam properties for delivery to the patient. On the Slit lamp LDU it is possible to adjust the spot size and the beam position relative to the Slit lamp Illumination.
  • Page 58 Optical Fiber This optical fiber connects between the Slit lamp LDU and the Laser Console. The treatment laser and aiming beams are focused into the fiber. 2. Zoom System and Truscan Housing This is where the pattern generated through the two high speed scanning motors.

  • Page 59: Integrated Cso Sl980 Controls Breakdown

    A. Integrated CSO SL980 Controls Breakdown The CSO Slit lamps can be used as a standard diagnostic tool and all the standard Slit lamp functions are available. The following figures 4.10a and 4.10b show all of the controls that can be found on the Slit lamps and the description of the components.

  • Page 60: B) Sl980 Slit Lamp Parts List And Controls

    CSO SL980 Slit lamp Controls continues... Figure 4.10(b) SL980 Slit lamp Parts List and Controls Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 – Operators Manual Rev. No 01 Page 59 of 126...

  • Page 61: Laser Indirect Ophthalmoscope (Lio)

    4.6 Laser Indirect Ophthalmoscope (LIO) The controls on the LIO (refer to Fig. 4.11a-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.
  • Page 62 Optical Fiber The optical fiber connects between the LIO and the Laser Console. The treatment and aiming beams are focused into the fiber. 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.
  • Page 63 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. Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 – Operators Manual Rev.

  • Page 64: Installation

    Section 5 Installation 5.1 Introduction It is strongly recommended that the manufacturer or its authorized agent install the Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 Pattern Scanning Laser System at the operator site to ensure that the system is operating correctly, aligned and calibrated according to specification.
  • Page 65 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. 6.

  • Page 66: Unpacking And Receiving Inspection

    Bottom Layer: LCD Control Panel / Arm Holder Figure 5.1 Packing Carton for Integrated LDU and Slit lamp LIGHTMED www.lightmed.com Figure 5.2 Portable Carry Cases for Console 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.

  • Page 67: Tools And Equipment

    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 delivery housing, binoculars, eyepieces, target rod, target plate, upper arm housing, lower base housing, dust covers, spare lamp, manual, delivery fiber, fiber holder, mains power cable and delivery fiber.

  • Page 68: Preparation

    5.4 Preparation Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 pattern scanning system is an integrated laser photocoagulation system where is also equipped with enhance, faster, and more precise laser scanning patterns and micro pulse features. The system will deliver predetermined patterns and controlling laser emission light through a single footswitch depression.
  • Page 69 A. System table top / motorized stand The table top and motorized stand are ready to use system therefore minimize installation is required. Prior to install the table top ass’y and motorized stand, ensure all the equipment are in placed to before proceeding to the installation steps. Caution: The table top and motorized stands are very heavy therefore an assistant may require to the installation process System part(s):...

  • Page 70: Inter-Power Connection (Left Hand Side)

    10. Lock the wheel stopper before proceeding to the next installation steps Do not over stretch the cabling or connection because it may cause loosen connector Figure 5.3 Inter-power connection (left hand side) Power plugs Protecting Layer Figure 5.4 Stands with power plugs facing each other Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 –...

  • Page 71: A) Rear View Box Connection

    Slit lamp power source connection Power source connection Fixation lamp connector Voltage rate setting Fixation lamp connection Figure 5.5 (a) Rear view box connection Figure 5.5 (b) Removal fuse socket Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 – Operators Manual Rev.

  • Page 72: C) Removal Fuse

    Figure 5.5 (c) Removal fuses Figure 5.5 (d) Voltage Setting Verification and Reinsert Back Process Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 – Operators Manual Rev. No 01 Page 71 of 126...

  • Page 73: Final Assembled Product And Verification Recheck

    up/down motor movement Power switch & control box Figure 5.6 Final assembled product and verification recheck Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 – Operators Manual Rev. No 01 Page 72 of 126...

  • Page 74: Ldu System / Lcd System / Footswitch / Accessories

    B. LDU Systems / LCD System / Footswitch / Accessories Three types of LDU system Lightmed manufacturing are:  Slit lamp (CSO980)  LIO (Optional)  Endoprobes (Optional) Slit lamp Integrated LDU (CSO980) Prior to install the Slit lamp Integrated system, ensure all the corrected setup and equipment are in placed to proceed the installation steps.

  • Page 75: Slit Lamp Packaging Ass'y

    10. Mount and secure the chinrest ass’y and ensure all the connections are plug in including slit lamp and fixation lamp power source connectors (refer to fig. 5.12) 11. Clamp the fiber support arm to the chinrest ass’y and gently position the delivery fiber to the Truscan aperture (refer to fig.

  • Page 76: Assembled Upper And Lower Housings Screw

    Housing Screw Figure 5.8 Assembled Upper and Lower Housing Screw Joystick cabling Delivery Housing with Truscan integrated Binocular Figure 5.9 Final Assembled Upper and Lower Housings Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 – Operators Manual Rev. No 01 Page 75 of 126...

  • Page 77: Cabling Stuffed Underneath Of Table Top's Cabling Gutter

    Figure 5.10 Cabling stuffed underneath of table top 's gutter Chrome Stop screw Figure 5.11 (a) Slit lamp arm ready for delivery housing Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 – Operators Manual Rev. No 01 Page 76 of 126...

  • Page 78: B) Fitting Delivering Housing To The Slit Lamp And Securing It

    Locking screw Figure 5.11 (b) Fitting Delivery housing to the Slit lamp and securing it Delivery fiber Velcro tie holder Fiber holder clamp Figure 5.12 Mounting Chinrest ass'y and fiber holder and fitting delivery fiber to Truscan aperture Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 – Operators Manual Rev.
  • Page 79 Delivery Key plug Port 2 Port 1 Figure 5.13 (a) Hang console and plug in all the front panel connections Power source LCD connection Footswitch connection Interlock key connection Scan Delivery Joystick cable connection Figure 5.13 (b) Console Rear End Connections Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 –...
  • Page 80 Figure 5.14 Arm rest installed Figure 5.15 (a) Clamp down the LCD Panel Holder in the middle of the gutter Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 – Operators Manual Rev. No 01 Page 79 of 126...
  • Page 81 Four holding screws Figure 5.15 (b) Organize the two control panel cablings and ready to fit the LCD Two cablings Figure 5.15 (c) Complete securing four holding screws behind the LCD panel and two cablings connected Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 – Operators Manual Rev.
  • Page 82 Figure 5.16 (a) Software System boot up Figure 5.16 (b) System Ready to operate Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 – Operators Manual Rev. No 01 Page 81 of 126...

  • Page 83: Final Verification / Checkout

    5.5 Final Verification / Checkout When the system is now fully setup, the final verification is required to conduct before demo or handle over to the user end. These performance procedures can be divided as follows:  Slit lamp Integrity Rechecks ...

  • Page 84: Laser Indirect Ophthalmoscope (Optional)

    B. Laser Indirect Ophthalmoscope (Optional) 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: Power on the console and ensure all the connection and connectors are in place (refer to fig.
  • Page 85 LIO Intensity Control Knob Figure 5.17 (c) LCD LIO Intensity Control Knob Light Aperture Setting Control LIO Intensity Control Knob Aiming spot light up/down Figure 5.17 (d) LIO Intensity Control Knob Verify the spot size or zoom system is accordingly (from smallest to largest size) Ensure the different light aperture setting is also functioned accordingly (refer to fig.

  • Page 86: Endoprobe (Optional)

    The endoprobe is sterilized single use device therefore there will be no installation procedures involved however, do want to make 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.

  • Page 87: Integrated System Initialization And Validation

    5.6 Integrated System Initialization and Validation Prior to power on the system, ensure all the connectors and connections are in place and the electrical standard is met the system specification. The initialization procedures are outlined as: A. LCD / Console Validation Power on the LCD and wait for the software to boot up completely without any issue or warning Check for any abnormality or error code process (refer to troubleshooting...
  • Page 88 7.2 Double clicks the LIO for entering to realign process Double clicks the LIO Icon 7.3 Enter password “123” and return the ‘Enter’ key 7.4 Initial the “Start” button and realign the X or Y axis accordingly Initial realignment process Y-axis alignment Initial ‘Save’...

  • Page 89: P A T T E R N S C A N C O N T R O L V A L I D A T I O

    C. Pattern Scan Control Validation 8. Engage the square pattern scanning (5x5) to see if the patterns are evenly distributed in X and Y axis if not, refer to the service manual realignment procedures 9. Validate all the control functions in the pattern scan controls screen are properly functioning 10.
  • Page 90 Figure 5.19(a) Front End Connection Remote Control Connection Figure 5.19(b) Rear End Connection 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 other end is connected to appropriate delivery system (refer to fig.
  • Page 91 3. Reset the emergency pushbutton by unscrewing outward position 4. Initial the console power by turning the key switch 5. Verify if the system passes the self-checking mode (refer to fig. 5.20a-c) if not, proceed to troubleshooting section otherwise proceed to next step 6.
  • Page 92 Installation Record Sheet Model: Multi-Wavelength Pattern Console Serial Nunber: __________________ Scanning System - LightLas 532 / 670 LIO Serial Number: _________________ Slit lamp LDU Serial Number: ______________ 1. System Setup (Tick for OK)  1.1 No damage to external box packaging ...
  • Page 93 5.2 Power on the console and validate if the display its integrity  5.3 Validate if there is any error or warming message during the boot up  sequence  5.4 Validate the all the keypad functionality 6. Integrated System Checks ...
  • Page 94 Section 6 CLINICAL USE The Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 is an Ophthalmic Laser intended to coagulate or burn structures within the patient’s 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.

  • Page 95: Different Types Of Ldus Indication / Contraindication Use

    Different types of LDUs Indication / Contraindication Use There are three different types of delivery system such as, Slit lamp Delivery unit, LIO and Endoprobes. They are explained in great detailed for their specific indication and countraindication uses as follows. 6.1.1 Slit lamp Delivery Unit The Slit lamp Delivery unit allows the treatment of many Retinal conditions and...

  • Page 96: Endoprobe Devices

    outside the arcades  Retinal tears  Lattice degeneration  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: ...
  • Page 97 Contraindications for use:  Do not treat albino patients, or eyes that have no pigmentation Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 – Operators Manual Rev. No 01 Page 96 of 126...

  • Page 98: General Warnings

    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.
  • Page 99  Any precaution measured should be taken during any surgical process. 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.

  • Page 100: Possible Side-Effect Or Adverse Reactions

    Possible side-effect or adverse reactions During or following surgical treatment with the Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 Laser there are some potential effects or reactions that should be considered. They are similar to any other surgical procedure and include: ...

  • Page 101: Maintenance

    Section 7 MAINTENANCE The Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 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.

  • Page 102: Laser Beam Alignment Check

    2. Cleaning the Optics The optical surfaces of the Laser System are; the objective lens, the illumination tower prism, the eyepieces and any other Slit lamp 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.

  • Page 103: System Output Power Checking Procedure

    System Output Power Checking Procedure This system output power checking procedures are intended to ensure the Multi- Wavelength Pattern Scanning System - LightLas 532 / 670 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.
  • Page 104 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.

  • Page 105: Section 8 Troubleshooting

    Section 8 TROUBLESHOOTING The Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 system is designed to have a service free part as possible. It is divided into three major sections such as, Symptom, Warning, and Error code. Note: Any warning and error code come with "hoLd" wording displaying in the counter display (refer to fig.
  • Page 106 circuit failure assistance No or low output of the -Fiber is damage -Check the fiber integrity by laser power replacing a new one -READY mode is not activated -Activate the READY mode -Output power not -Selected the specified power selected -If the problem persists, call the -Laser cavity decayed authorized service or...

  • Page 107: Warning

    8.2 Warning The Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 system can interface either with LCD stationery or remote control model setup and a completed listing of system warnings and the suggested corrective actions are detailed as following: A.
  • Page 108 Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 – Operators Manual Rev. No 01 Page 107 of 126...
  • Page 109 Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 – Operators Manual Rev. No 01 Page 108 of 126...
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  • Page 113: Remote Control Warning Only

    Remote Control Warning Only Warning Cause(s) Remedy Action(s) inL rE-F -Fiber not connected -Check the fiber connection -Interlock plug not -Check the Interlock connection connected -If the problem persists, call the authorized service or manufacturer for further assistance inL con -Footswitch not -Check if the footswitch is connected...

  • Page 114: Error Codes

    8.3 Error Codes If during normal operation of the Laser System or during the Start up 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 LCD control display panel.
  • Page 115 A complete listing of the Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 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...
  • Page 116 time of frame of 300ms for further assistance 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...
  • Page 117 the preset power value Err 5123 - No Power -The measured o/p laser -Call the authorized service or power is less than 10mW manufacturer for further assistance while the duty cycle is set Err 5123 - No Power -The measured o/p laser -Call the authorized service or power is less than 10mW manufacturer for further assistance...

  • Page 118: European Community Issues

    Section 9 European Community Issues 1. Declaration of Conformity LightMed Corporation declares that the Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 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.
  • Page 119 in a devices appendix. 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.

  • Page 120: Emc Test Tables

    Section 10 EMC Test Tables Guidance and manufacturer’s declaration – electromagnetic emissions Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 is intended for use in the electromagnetic environment specified below. The customer or the user of the Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 should assure that it is used in such an environment.
  • Page 121 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.
  • Page 122 for 25 cycles for 25 cycles a 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...
  • Page 123 Guidance and manufacturer’s declaration – electromagnetic immunity Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 is intended for use in the electromagnetic environment specified below. The customer or the user of Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 should assure that it is used in such an environment.
  • Page 124 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.
  • Page 125 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 TB0009,TS0005  Integrated Laser Slit lamp Delivery Part Number SD0000 ...
  • Page 126  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 (Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 ).
  • Page 127 Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 – Operators Manual Rev. No 01 Page 126 of 126...

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