Lightmed TruScan 532 Operator's Manual
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Lightmed TruScan 532 Operator's Manual

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Summary of Contents for Lightmed TruScan 532

  • Page 1 Operator's Manual TruScan 532 Single- Wavelength...
  • Page 2 Operator's Manual for the TruScan 532 Single- Wavelength Directive 93/42/EEC as amended by 2007/47/EC Doc. No. : DC1801 Rev. No. : 02 TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 1 of 114...
  • Page 3 Operator's Manual for the TruScan 532 Single-Wavelength Clinicians or/and Doctors should ensure that they are adequately knowledge of the operation or training prior to using the TruScan 532 Single-Wavelength Photocoagulator Laser equipment. This Operator's Manual should be studied and understood before proceeding to operate the equipment on patients.

  • Page 4: Table Of Contents

    Table Top and Motorized Stands ............66 B. LDU Systems/LCD/Footswitch/Accessories ........71 Final Verification / Checkout ................79 A. Slit Lamp ..................... 79 B. LIO ......................81 C. Endoprobe ..................83 TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 3 of 114...
  • Page 5 7.3 System Output Power Checking Procedure ..........101 Section 8 TROUBLESHOOTING ..................103 Symptom / Warning ..................103 Warning ......................105 Error Codes ..................... 107 Section 9 Warranty Term ....................110 TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 4 of 114...
  • Page 6 Cabling Stuffed Underneath of Table Top Cabling Gutter 5.10 Slit Lamp Arm Ready for Delivery Housing 5.11(a) Delivery Housing Fitting Process 5.11(b) Delivery Fiber Holder Process 5.12 TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 5 of 114...
  • Page 7 Initial Aiming Intensity Verification Sample of Error Code Display Record Sheet Installation Record Sheet 90/91 System Throughput Power Record Sheet Appendix Appendix I (Optional Accessories) TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 6 of 114...

  • Page 8: Introduction

    Before using the TruScan 532 Single-Wavelength Photocoagulator Laser system the operator should read this manual carefully and pay particular attention to the sections of Safety, Operation and Maintenance. TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 7 of 114...

  • Page 9: Safety

    Product Classifications The TruScan 532 Single-Wavelength Photocoagulator Laser is a Class IV laser product as specified in the standard IEC60825-1 (2007) and USA 21 CFR’s 1040.10 and 1040.11.

  • Page 10: Warnings And Precautions

    EN ISO14971 Warnings and Precautions The following warnings and precautions apply to the TruScan 532 Single-Wavelength Laser System and should be observed by all users at all time:  DO NOT look directly into or at the laser beam or at specular laser reflections...

  • Page 11: Optical Hazards

    Guidance for the safe use of Lasers and Laser systems is found in the standard IEC60825- 1, the USA 21CFR 1040.10 and 1040.11, and ANSI Z136.1 - 1986. During normal operation of the TruScan 532 Single-Wavelength 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.

  • Page 12: Avoid Exposure To Laser Beams

    The calculated NOHD for the TruScan 532 / Single-Wavelength with different Laser Delivery Units is:  5 meters at maximum power settings for the Endoprobes  18 meters at maximum power settings and 1000m spot size for Slit lamp Delivery Units ...

  • Page 13: Electrical Hazards

    AC voltage where the third prong pin is the earth- grounded prong. Warning: It is not safe to operate the TruScan 532 Single-Wavelength photocoagulator laser without an earth-grounded receptacle. There is possible risk of electric shock.

  • Page 14: Safety Controls And Features

    The system is equipped with numerous safety controls and features that are complied with standard regulation and more detailed are outlined below figure. Figure 2.1 Safety Controls and Features TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 13 of 114...
  • Page 15 The System will go back into the STANDBY mode, if it is unoperated for 10 mins or deactivated. Remote Door Interlock Connector TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 14 of 114...
  • Page 16 When the TruScan 532 Single-Wavelength is first turned on the microprocessor performs various checks to ensure that the Laser is functioning correctly. If the self-check test passes then the unit goes to the STANDBY mode.

  • Page 17: Product Labeling

    Product Labeling All the labels on the TruScan 532 Single-Wavelength complies with the requirements of the various regulatory standards refer to previously. Console system A full detailed of all the safety and control labels is shown in the figures 2.2 and 2.3.

  • Page 18: Laser Console Safety Labels

    Console system continues... Figure 2.3 Laser Console Safety Labels TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 17 of 114...

  • Page 19: A) Integrated Slit Lamp Ldu With Labels (Rh Side)

    Integrated Slit lamp LDU Figure 2.4(a) Integrated Slit lamp LDU with labels (RH side) TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 18 of 114...
  • Page 20 Integrated Slit lamp LDU continues... Figure 2.4(b) Integrated Slit lamp LDU with labels (LH side) TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 19 of 114...

  • Page 21: Lio Ldu With Labels

    CLASS 4 LASER PRODUCT IEC/EN 60825-1:2007 Keeler WARNING Only use with 532nm Laser LITHTMED Ser # : WARNING 0434 Only use with 532nm Laser Figure 2.5 LIO LDU with labels TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 20 of 114...

  • Page 22: Product Specifications

    Section 3 PRODUCT SPECIFICATIONS TruScan 532 Single-Wavelength Pattern Scanning Laser System Specification The following are the System Specifications for the TruScan 532 Single-Wavelength Ophthalmic Laser. Console Laser System General Specification Electrical 100 to 230 Vac. 50/60 Hz Single phase Input...
  • Page 23 50m ~1000 m continuously selectable on Zoom assembly of Spot Sizes Delivery unit Focus plane All spot sizes Parfocal to Slitlamp focus plane Fiber Length Mounting Direct to Slitlamp housing TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 22 of 114...
  • Page 24 Sterilized by Ethylene Oxide and packed as Single use devices ready for use Beam 0.2 NA Divergence Safety filter Safety Filters OD 4 @ 532nm TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 23 of 114...
  • Page 25 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 TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 24 of 114...

  • Page 26: Principles Of Operation

     Laser Trabeculoplasty The TruScan 532 Single-Wavelength Laser system has a wavelength of 532nm, which is in the visible spectrum and is the Green light. A red aiming beam is used to position the treatment laser light beam prior to delivering.
  • Page 27 All the normal functions of a Slit lamp are available to the operator when using the TruScan 532 Single-Wavelength 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 28 1000µm in a continuous adjustment for the Integrated SL980 design. TruScan system is integrated with SL980, the laser beam for LightLas Multi-Wavelength Pattern Scanning System-TruScan 532 Single-Wavelength laser beam is delivered to the patient’s eye by a high speed galvanometer scanner. The doctor has to select the scanning pattern before treatment and spot size is adjustable from 50m to 1000m.
  • Page 29 LCD display control panel and eventually will show error code (for more detailed refer to troubleshooting section of this manual). This process usually takes less 5 mins. TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 28 of 114...

  • Page 30: System Software Start Up Screen Shot

    Figure 4.2 System software boot up ok and system is "Standby" mode All operating conditions and switches are shown on the LCD control panel. The LCD control panel display consists of:  Laser Power TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 29 of 114...
  • Page 31 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 TruScan 532 Single-Wavelength Laser System. In STANDBY mode, the footswitch is disabled and the shutter module blocker will obstruct the beam path is closed.
  • Page 32 (refer to fig. 4.3). The user/doctor is expected to be trained and have knowledge in the intended use and TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 31 of 114...

  • Page 33: System Software Is Ready To Shutdown

    (Refer to Section 9 of this manual). The patient cannot have any influence over the operation and control of the TruScan 532 Single-Wavelength Laser. 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.

  • Page 34: Laser Console

    4. Delivery Key Connector 5. LIO Power 6. Main Power Inlet 7. Footswitch Connector 8. Joystick Connector 9. Remote Interlock Connector 10. Scan Delivery 11. COM Port TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 33 of 114...
  • Page 35 On/Off switch. This footswitch can be in wire or wireless module. 8. Joystick Connector This connector is used to feedback or monitor joystick movement during normal operation. 9. Remote Interlock Connector TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 34 of 114...
  • Page 36 It is a regulatory requirement that the TruScan 532 Single-Wavelength has this safety feature connector available. Two wires can be wired out from the interlock switch to the treatment door’s switch and once the door opens the circuitry will be opened causing the system to be disabled.

  • Page 37: Lcd Control Panel Display Screen

    (refer to fig. 4.5). Console Control Screen Pattern Scan Control Screen Figure 4.5 Screen shot display TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 36 of 114...

  • Page 38: Console Control Screen

    17. Type of System Wavelength Indicator in Port 1 Type of System Wavelength Indicator in Port 2 19. Sub-Threshold Toggle Mode 20. Sub-Threshold Duty Cycle Selection Icon TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 37 of 114...
  • Page 39 This display shows the repeat interval exposure duration in seconds. 8. Repeat Interval setting switches These switches are used to set the repeat interval duration, which is the time TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 38 of 114...
  • Page 40 This bar graph is the intensity indicator. 12. LIO Illumination Setting button When the LIO is connected to the TruScan 532 Single-Wavelength Laser Console, this control can be used to adjust the intensity of the Illumination lamp. 13. Warning Volume Control Button / Display Bar This control can be used to adjust the volume of the laser fire audible warning.
  • Page 41 The duty cycle "On" time over the total "Off" time (2000μs) will be the individual duty cycle percentage for example, 10% duty cycle = power "On" time 200μs / power "Off" time 2000μs. TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 40 of 114...

  • Page 42: Pattern Scan Control Screen

    9. Pattern Spacing Function 10. Pattern Radius Function 11. Query or Help Function 12. Customized Parameter Folder 13. Save Function 14. Shutdown Function Button 15. Pattern Display Area TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 41 of 114...
  • Page 43 This means that the system will record the last position. The final or pre selection will display in the pattern display area. Available parameter setting can be selected as follows: - Spot size:50μm~1000μm TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 42 of 114...
  • Page 44 Available parameter setting can be selected as follows: - Spot size: 100-500μm - Spacing: 0.5, 1.0, 1.5 and 2.0 Ф (not available in 500μm) - Rotation: 0, 45, 90, and 135 degree TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 43 of 114...
  • Page 45 Available parameter setting can be selected as follows: - Spot size: 100-500μm - Spacing: 0.5, 1.0, 1.5 and 2.0 Ф (not available in 500μm) - Rotation: 0 and 45 degree TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 44 of 114...
  • Page 46 Available parameter setting can be selected as follows: - Spot size: 100-500μm - Spacing: 0.5, 1.0, 1.5 and 2.0 Ф (not available in 500μm) - Rotation: 0, 90, 180 and 270 degree TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 45 of 114...
  • Page 47 Available parameter setting can be selected as follows: - Spot size: 200-500μm - Spacing: 1.0-2.0 Ф - Radius: 1000 / 1500 / 2000μm - Rotation: 0 ,90,180,270 degree (except full circular pattern) TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 46 of 114...
  • Page 48 - Radius: 1500 (only at 200, 300, and 400μm spot size interval) / 2000μm (only at 200μm in spot size interval) in double arc pattern only TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 47 of 114...
  • Page 49 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 Ф - Rotation: 0 ,90,180,270 degree TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 48 of 114...
  • Page 50 This buttom will shutdown the LCD touch panel but not the console. 15. Pattern Display Area This area will show the preset patterns prior to treat mode. TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 49 of 114...

  • Page 51: Remote Control Panel

    15. Secondary Laser System Wavelength 16. Port 2 Indicator Selection 17. System Selection Engaged Button 18. Counter Reset Switch / LIO Intensity Activation 19. Total Laser Counts Display TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 50 of 114...
  • Page 52 1.0mw to patient’s cornea. 6. Aiming Beam Intensity switches The brightness of the Aiming beam is adjusted with these 2 switches. TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 51 of 114...
  • Page 53 This indicator is used to display the secondary laser system wavelength selection. 16. Port 2 Indicator This indicator is used to display the port 2 activation. TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 52 of 114...
  • Page 54 "LIO" wording display on the aiming intensity LED display. Then the system shall able to control the LIO intensity through aiming intensity buttons control switches. TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 53 of 114...

  • Page 55: Truscan Integrated Into Cso Model Sl980

    AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION CLASS 4 / IV LASER PRODUCT IEC60825-1 2007 SD3100-03 Figure 4.9 Integrated Slit lamp LDU Controls TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 54 of 114...
  • Page 56 Slit lamp LDU system can be integrated with two types of the slit lamp that carry by Lightmed are as:  CSO SL980 (Integrated with Slit lamp) More detailed breakdown is shown in section 4.7 (page 61 to 62) TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 55 of 114...

  • Page 57: Laser Indirect Ophthalmoscope (Lio)

    Illumination spot or the fitment of the unit for the doctor. More detailed breakdown description can be found in the following pages. Figure 4.10(a) Front View of LIO LDU Control Figure 4.10(b) Top View of LIO LDU Controls TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 56 of 114...
  • Page 58 10. Illumination Cable This cable connects to the Laser Console front panel and provides the power for the Illumination Lamp. TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 57 of 114...

  • Page 59: Integrated Cso Sl980 Controls Breakdown

    The following figures 4.6 and 4.7 show all of the controls that can be found on the Slit lamps and the description of the components. CSO SL980 Slit lamp Controls TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 58 of 114...
  • Page 60 CSO SL980 Slit lamp Controls continues... Figure 4.11 SL980 Slit lamp Parts List and Controls TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 59 of 114...

  • Page 61: Installation

    Introduction and Requirements It is strongly recommended that the manufacturer or its authorized agent install the TruScan 532 Single-Wavelength Pattern Scanning Laser System at the operator site to ensure that the system is operating correctly, aligned and calibrated according to specification.
  • Page 62 7.2 and 7.3 of this Operator Manual. 7. The TruScan 532 Single-Wavelength 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.

  • Page 63: Unpacking And Receiving Inspection

    TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 62 of 114...

  • Page 64: Tools And Equipment

    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 TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 63 of 114...

  • Page 65: Preparation

     LDU system (Slit lamp / LIO / Endoprobes)  LCD touch screen panel integrated with computer windows platform system  Footswitch  Accessories (Remote Control, Chinrest, Target Rod, Binocular...etc.) TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 64 of 114...
  • Page 66 7. Ensure the all the bolt nuts are fasten secure prior to roll up Caution: You may need an assistant to roll up the fully assembled TruScan 532 Single-Wavelength table because it is very heavy and dangerous to lift-up the table ass’y by individual.
  • Page 67 Power plugs Figure 5.3 Inter-power connection (Right hand side) Power plugs Protecting Layer Figure 5.4 Stands with power plugs facing each other TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 66 of 114...
  • Page 68 Voltage rate Fixation lamp connection setting TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 67 of 114...
  • Page 69 Slit lamp source power connection source connection Voltage rate setting Fixation lamp connection Figure 5.5 (a) Rear view box connection Figure 5.5 (b) Removal fuse socket TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 68 of 114...
  • Page 70 Figure 5.5 (c) Removal fuses Figure 5.5 (d) Voltage Setting Verification and Reinsert Back Process TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 69 of 114...
  • Page 71 Power switch & control box Up /down motor movement Figure 5.6 Final assembled product and verification recheck TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 70 of 114...

  • Page 72: Ldu Systems/Lcd/Footswitch/Accessories

    8. Place the gear cover ass'y Glide the delivery housing with Truscan module integrated until it reaches to the chrome stopper and gently secure the screw (refer to fig. 5.11a-b) TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 71 of 114...
  • Page 73 Chinrest Ass'y Dust Cover / Accessories Lower Base Housing PS Head Connector Upper Arm Housing Binocular Figure 5.7 Slit lamp Packaging Ass’y TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 72 of 114...
  • Page 74 TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 73 of 114...
  • Page 75 Housing Screw Figure 5.8 Housing Screw location Delivery Housing with Truscan integrated Joystick cabling Binocular Figure 5.9 Assembled Upper and Lower Housings and organized Cabling TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 74 of 114...
  • Page 76 Figure 5.10 Cabling stuffed underneath of table top cabling gutter Chrome Stop screw Figure 5.11 (a) Slit lamp arm ready for delivery housing TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 75 of 114...
  • Page 77 Figure 5.11 (b) Delivery housing Fitting process Delivery fiber Fiber holder clamp Figure 5.12 Mounting Chinrest ass'y and fiber holder and fitting delivery fiber to Truscan aperture TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 76 of 114...
  • Page 78 Figure 5.13 (a) Hang console and plug in all the front panel connections Figure 5.13 (b) Plug in all the rear panel connections TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 77 of 114...
  • Page 79 Figure 5.14 Clamp down the LCD Panel Holder in the middle of the gutter Figure 5.15 (a) Software System boot up TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 78 of 114...
  • Page 80 Figure 5.15 (b) System Ready to operate TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 79 of 114...

  • Page 81: Final Verification / Checkout

    2. Set a narrow slit width with low intensity illumination and verify that the slit is focused if not, follow through the below steps: A. Set the target rod up and ensure the objective and target rod are perpendicular TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 80 of 114...
  • Page 82 9. Check the eyepiece firmly fit into the binocular and can be fully adjusted 10. Illumination tower and binocular arm can be swung side to side TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 81 of 114...
  • Page 83 Figure 5.16 (b) Fiber tips cleaning Verify the aiming beam is being delivered correctly from LIO by shooting against the wall and set a focal distance of 30cm approximately TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 82 of 114...
  • Page 84 Ensure the different light aperture setting is also functioned accordingly (refer to fig. 5.16d) Ensure aiming spot light is able to tilt in up/down position (refer to fig. 5.16d) TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 83 of 114...
  • Page 85 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. TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 84 of 114...

  • Page 86: Initialization Equipment

    6. Validate if the zoom pc marked spot size vs. display spot size values are accordingly when rotating the pc otherwise follow through the below procedures: TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 85 of 114...
  • Page 87 6.1 Enter to spot calibration mode by double clicks the LIO icon Double clicks 6.2 Enter passcode: “777” 6.3 Initial the “Spot Size Calibration” icon TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 86 of 114...
  • Page 88 7.1 Ensure the “Ready” mode is activated and set the spot position in 50um Initial "Ready " mode 7.2 Double clicks the LIO icon for accessing the calibration Double clicks 7.3 Enter passcode: “777” TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 87 of 114...
  • Page 89 Save the value when it is completed it and exit it Reset the console power and validate it TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 88 of 114...

  • Page 90: Pattern Scan Control Validation

     Footswitch (wire or wireless)  Optical fiber (link from console aperture to the LDU could be Endoprobe or standard delivery one)  Interconnector  On/Off Switch Key TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 89 of 114...
  • Page 91 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 TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 90 of 114...
  • Page 92 Figure 5.19(a) System boot up sequential display Figure 5.19(b) System boot up sequential display Figure 5.19(c) System boot up sequential display Figure 5.20 Initial Aiming Intensity Verification TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 91 of 114...
  • Page 93 5. Remote / console checks (optional)  5.1 Plug in the remore control into console 5.2 Power on the console and validate if the display its integrity  TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 92 of 114...
  • Page 94 Installers Name : ______________________ Date: __________________ Distributor Name: ______________________ Date: __________________ Customer Name : ______________________ Date: __________________ (Send this Installation Report to the Manufacturer immediately) TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 93 of 114...

  • Page 95: Clinical Use

    Section 6 CLINICAL USE The TruScan 532 Single-Wavelength 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 96: Different Types Of Ldus Indication / Contraindication Use

    Indications for use:  Proliferative and nonproliferative diabetic retinopathy with pathology outside the arcades  Retinal tears TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 95 of 114...

  • Page 97: Endoprobe Devices

     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 TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 96 of 114...

  • Page 98: General Warnings

     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. TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 97 of 114...
  • Page 99 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 TruScan 532 Single-Wavelength Laser. Due to the individual lens coating can affect the treatment performance quality which may result in poor treatment.

  • Page 100: Possible Side-Effect Or Adverse Reactions

    Possible side-effect or adverse reactions During or following surgical treatment with the TruScan 532 Single-Wavelength 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.

  • Page 101: Maintenance

    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 TruScan 532 Single- Wavelength has the Power meter calibrated to a known calibrated meter and have its earth leakage current and earth resistance measured according to EN60601-1.

  • Page 102: Laser Beam Alignment Check

    Console is OK. System Output Power Checking Procedure This system output power checking procedures are intended to ensure the TruScan 532 Single-Wavelength 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 TruScan 532 Single - Wavelength –...
  • Page 103 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 TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 102 of 114...
  • Page 104 Min. / Max. Pass / Fail 100 mw 80 / 120 mw 500 mw 400 / 600 mw 1000 mw 800/1200 mw 1500 mw 1200/1800mw TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 103 of 114...

  • Page 105: Troubleshooting

    -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 TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 104 of 114...
  • Page 106 -Output power not -Selected the specified power selected -If the problem persists, call the -Laser cavity decayed authorized service or manufacturer for further -Electronics assistance malfunction TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 105 of 114...

  • Page 107: Warning

    System Warning Message Corrected Actions A complete listing of the TruScan 532 Single-Wavelength system warning along with the suggested corrective actions are shown below: Error code Cause(s) / Description Remedy Action(s) Safety filter not -Safety filter not connect...
  • Page 108 -Please wait while the console adjusts Temperature Not Temperature is not ready itself according to ambient Ready temperature -This process may take up to five minutes to complete. TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 107 of 114...

  • Page 109: Error Codes

    Description Remedy Action(s) Error code Figure 8.1 Sample of Error code display A complete listing of the TruScan 532 Single-Wavelength error codes along with the suggested corrective actions are shown below: Error code Cause(s) / Description Remedy Action(s) Err 500 - ROM...
  • Page 110 Err 5053 - Remote -mismatched code in the -Reboot the system ROM Error remote software when -If the problem persisted, call the TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 109 of 114...
  • Page 111 Err 513 - System -The system stop running -Call the authorized service or Error for 1ms manufacturer for further assistance TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 110 of 114...

  • Page 112: Warranty Term

    Except as expressed above the manufacturer makes no other warranty of any kind, express or implied, including warranties of merchantability of fitness for any particular purpose or use. TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 111 of 114...
  • Page 113  Attachment Laser Delivery Unit (Zeiss 30SL style) Part Number ZS0000,ZS0002  Attachment Laser Delivery Unit (LightMed SYL9000) Part Number YG0003,YG0004  Delivery attachment (adapter) for LightLas YAG Truspot Part Number AD0021 TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 112 of 114...
  • Page 114 Part Number LCA180 Attention: The accessories are passive (do not emit laser radiation) and depend on the main device (Lightmed TruScan 532 Single - Wavelength). TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 113 of 114...
  • Page 115 TruScan 532 Single - Wavelength – Operators Manual Rev. No 02 Page 114 of 114...

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