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TruScan 532 Single - Wavelength – Operators Manual Rev. No 02

Page 13 of 114

2.5

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

Summary of Contents for TruScan 532

Page 1: ...Operator s Manual TruScan 532 Single Wavelength ...

Page 2: ...TruScan 532 Single Wavelength Operators Manual Rev No 02 Page 1 of 114 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 ...

Page 3: ...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 Operator s Manual contains confidential and proprietary information of the Manufacturer Manufactured by LightMed Corporation No 1 1 Lane 1 Sec 3 Pao An St Shulin District New Taipei City 23861 Taiwan USA Address 1130 Calle Cordillera San Clemente CA 92673 Tel No 9...

Page 4: ...ifications 24 Section 4 PRINCIPLES OF OPERATION 26 4 1 General Description 25 4 2 Laser Controls and Displays 34 A Laser Console 34 B LCD Control Panel Display Screen 37 Console Control Screen 38 Pattern Scan Control Screen 42 4 3 Remote Control Panel 51 4 4 TruScan Integrated into CSO model SL980 55 4 5 Laser Indirect Ophthalmoscope LIO 57 4 6 Integrated CSO SL980 Controls Breakdown 59 Section 5 ...

Page 5: ...LINICAL USE 93 6 1 Different types of LDUs Indication Contraindication Use 95 6 1 1 Slit lamp Delivery Unit 94 6 1 2 Laser Indirect Ophthalmoscope LIO 94 6 1 3 Endoprobe devices 95 6 2 General Warnings 96 6 3 Possible side effect or adverse reactions 98 Section 7 MAINTENANCE 99 7 1 Operator User Maintenance 99 7 2 Laser Beam Alignment Check 100 7 3 System Output Power Checking Procedure 101 Sectio...

Page 6: ...wn 50 4 9 Integrated Slit lamp LDU Controls 54 4 10 a Front View of LIO LDU Controls 56 4 10 b Top View of LIO LDU Controls 56 4 11 SL980 Slit lamp Parts List and Controls 58 59 5 1 Packing Carton for integrated LDU and slit lamp 62 5 2 Portable Carry Cases for Console 62 5 3 Inter power connection Right hand side 66 5 4 Stands with power plugs facing each other 66 5 5 a Rear view box connection 6...

Page 7: ... Front Panel 80 5 16 b Fiber Tips Cleaning 80 5 16 c LCD LIO Intensity Control 81 5 16 d LIO Control Knob 81 5 17 Endoprobe Coupling Plug Assembling Process 82 5 18 a Front End Connection 88 5 18 b Rear End Connection 88 5 19 a System Boot Up Sequential Display 1 89 5 19 b System Boot Up Sequential Display 2 89 5 19 c System Boot Up Sequential Display 3 89 5 20 Initial Aiming Intensity Verificatio...

Page 8: ...rer 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...

Page 9: ...32 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 The TruScan 532 Single Wavelength Photocoagulator Laser is classified as Class I Type B Electromedical equipment as specified in the IEC60601 1 standard The TruScan 532 Single Wavelength Photocoagulator Laser is classified as a Class II device acc...

Page 10: ...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 treati...

Page 11: ... 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 of 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 a...

Page 12: ...nce 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 physician s eyes from back scattered laser beams must always be used They...

Page 13: ...erminal prongs 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 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...

Page 14: ...ev No 02 Page 13 of 114 2 5 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 ...

Page 15: ...he READY mode and footswitch is activated There are electronic sensors that check the position of the shutter at all times for the microprocessor Whenever the system boots up it will check for the shutter position to validate if the shutter is engaged and functioned Another safety check is the fiber holder detecting sensor feedback loop where the system will display a warm message if this fiber no...

Page 16: ... and cannot be turned off 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 In addition to these particular safety controls there are a number of features that have been built in to the TruScan 532 Single Wavelength All the safety...

Page 17: ... 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 Figure 2 2 Laser Console Safety and Control Labels ...

Page 18: ...TruScan 532 Single Wavelength Operators Manual Rev No 02 Page 17 of 114 Console system continues Figure 2 3 Laser Console Safety Labels ...

Page 19: ...TruScan 532 Single Wavelength Operators Manual Rev No 02 Page 18 of 114 Integrated Slit lamp LDU Figure 2 4 a Integrated Slit lamp LDU with labels RH side ...

Page 20: ...TruScan 532 Single Wavelength Operators Manual Rev No 02 Page 19 of 114 Integrated Slit lamp LDU continues Figure 2 4 b Integrated Slit lamp LDU with labels LH side ...

Page 21: ...IEC EN 60825 1 2007 CAUTION DANGER 400 500 300 Keeler Ser LITHTMED Only use with 532nm Laser WARNING WARNING Only use with 532nm Laser 0434 VISIBLE LASER RADIATION AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION CLASS 4 LASER PRODUCT IEC EN 60825 1 2007 CAUTION DANGER 0434 0434 DANGER CAUTION Visible when open DIRECT OR SCATTERED RADIATION AVOID EYE OR SKIN EXPOSURE TO Figure 2 5 LIO L...

Page 22: ...ge Transport 10 to 70 C Operating 15 to 30 C Storage 10 to 55 C 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 TEC s for Laser Diode and Crystal Dimensions 130mm H x 370mm W x 330mm D Weight 13 Kg System 20 Kg Packed Treatment Laser La...

Page 23: ... time 20 400µs On time 30 600µs On time Doctor Safety Filter OD4 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 635nm Red Mode of Operation CW Output power Maximum of 1 0mW Power Adjustment Continuously variable Safety Class Class 2 Laser Delivery Units Integrated Slitlamp LDU Slitlamp model CSO Model S...

Page 24: ...0µm nominal at focus with 20D Laser Lens Illumination power From Laser Console Internal PSU allows intensity adjustment Connector is on Console Front Panel Fiber length 3 m Weight Less than 500gms without laser attachment Safety Filter Fixed filter OD 4 Beam Divergence Cone angle 20c Endo ocular Probes Probe Types Straight Curved and Aspirating Fiber Length 3 m Safety Filters OD 4 in housing for i...

Page 25: ...an illumination source below the viewing path Microscope Galilean Magnification Set 5 Step Drum Rotation Eyepiece 12 5X Magnification Ratio 5X 8X 14X 24X 36X PD Range 48 5 80mm Diopter Adjustment 8 Slit Illumination 6V 20W Halogen Lamp Slit Width 0 14mm SL980 Slit Length 1 8 12mm Slit Apertures 0 3 5 5 9 14mm SL980 Slit Angles 0 180 Filters Red Free Heat Absorbing Cobalt Blue Movement Ranges Longi...

Page 26: ... 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 ...

Page 27: ...n 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 doctor s requirements However even in this mode the laser is always under the control of the doctor s the foot...

Page 28: ... 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 When using the Endoprobes the doctor will use an Operating Microscope to view the patient s eye These probes are inse...

Page 29: ...d optics system Thermal Electric Coolers and Driver units Electronic Microprocessor control system Power supply Mains power must be connected to the laser system and LCD control panel display in order for system to have a power be activated first Secondly power on the LCD control panel display first by pressing the power switch located at the bottom of the screen and await for the system to boot u...

Page 30: ...2 Page 29 of 114 Figure 4 1 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 ...

Page 31: ...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 READY mode it is recommended that all operating conditions are to be set correctly such as patient positioning power selection pulses duration i...

Page 32: ...tected 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 clos...

Page 33: ... 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 As the laser system is designed to deliver the laser beam to heat the...

Page 34: ...nsole 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 Figure 4 4 Laser Console Connection Controls Legend 1 Emergency Stop Switch 2 Key Switch 3 Laser Aperture Port 1 Port 2 4 Delivery Key Connector 5 LIO Power 6 Main Power Inlet 7 Footswitch Connector 8 Joystick Connector 9 Remote Int...

Page 35: ...he Laser to function No laser beam can be delivered through this aperture 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 Power This connector is used to supp...

Page 36: ...d 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 connector is supplied with each console and it must insert in order for the system to operate correctly 10 Scan Delivery This connector will monitor and interface signal with Truscan ...

Page 37: ...res several types 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 4 5 Figure 4 5 Screen shot display Console Control Screen Pattern Scan Control Screen ...

Page 38: ... Control Screen Legend 1 STANDBY Mode Button 2 READY Mode Button 3 Set Power Display 4 Power Control Button 5 Exposure Duration Display 6 Exposure Duration Button 7 Repeat Interval Display 8 Repeat Interval Setting Button 9 Aiming Beam Intensity Bar Indicator 10 Aiming Beam Intensity Button 11 LIO Illumination Intensity Bar Indicator 12 LIO Illumination Setting Button 13 Volume Control Button Disp...

Page 39: ... the reconfiguration is made The setting can be adjustable from 50 mW to 2000 mW By pressing the up down buttons will increase or decrease the power value The setting will be reset it when power is down 5 Exposure Duration Display This display shows the exposure duration setting in seconds 6 Exposure Duration setting switches These two switches control the duration of the exposure time that the tr...

Page 40: ...ication of the brightness of the Aiming beam intensity When more of the bar graphs are displayed then the brightness is higher At the maximum brightness the output power will be around 1 0mw or less to the patient s cornea 10 Aiming Beam Intensity button The brightness of the Aiming beam is adjusted with these 2 switches 11 LIO Illumination Intensity Bar Indicator This bar graph is the intensity i...

Page 41: ...reshold When the icon sink in it means enable state mode and when it grey out it means off state When it is on the individual duty cycle selection is displayed including the On time 21 Sub Threshold Duty Cycle Selection Icon This individual sub threshold duty cycle selection icon is used to toggle or select different selections It ranges as follows 7 5 150µs On time 10 200µs On time 12 5 250µs On ...

Page 42: ...ture and repetition rate More detailed are explained in the following Figure 4 7 Pattern Scan Control Screen Shot Legend 1 Single Spot 2 Straight Line Pattern Scan 3 Square Pattern Scan 4 Triangle Pattern Scan 5 Circle Pattern Scan 6 Arc Pattern Scan 7 Curvature Pattern Scan 8 Pattern Rotation Function 9 Pattern Spacing Function 10 Pattern Radius Function 11 Query or Help Function 12 Customized Pa...

Page 43: ...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 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 ...

Page 44: ...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 0 5 1 0 1 5 and 2 0 Ф not available in 500μm Rotation 0 45 90 and 135 degree ...

Page 45: ...ed 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 4 x 4 5 x 5 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 ...

Page 46: ... 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 0 5 1 0 1 5 and 2 0 Ф not available in 500μm Rotation 0 90 180 and 270 degree ...

Page 47: ...e screen and the final or pre selection will display in the patter display area Its sub selection type is listed below Full circle 3 4 circle 1 2 circle 1 4 circle 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 ...

Page 48: ...rea Its sub selection type is listed below Triple Arc Rings Double Arc Rings Available parameter setting can be selected as follows Spot size 200 500μm Spacing 1 0 2 0 Ф only at 200 300μm spot size interval in triple arc pattern Rotation 0 90 180 and 270 degree Radius 1500 only at 200 300 and 400μm spot size interval 2000μm only at 200μm in spot size interval in double arc pattern only ...

Page 49: ...ed 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 Ф Rotation 0 90 180 270 degree ...

Page 50: ...t the different radius between the circular arc and curve pattern and it is located in the mid bottom of the screen The button is activated when it is displayed 11 Query or Help Function This function will assist in the event of clarification required and it is always link to the manual for the cross reference 12 Customized Parameter Folder This folder contains all the customized setting or parame...

Page 51: ...tion Setting Switches 3 Repeat Interval Display 4 Repeat Interval Setting Switches 5 Aiming Beam Intensity Indicator Display 6 Aiming Beam Intensity Setting Switches 7 Power Control Adjuster 8 Set Power Display 9 Treat Indicator 10 Standby Indicator 11 Mode Switch 12 SP Mode Indicator 13 Micro Pulse Engaged Button 14 Primary Laser System Wavelength Selection 15 Secondary Laser System Wavelength Se...

Page 52: ...ning 4 Repeat Interval setting switch 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 fir...

Page 53: ...ted This is also used to provide a ready indicator prior to emissions of the laser treatment 10 Standby Indicator When this yellow indicator is illuminated the laser system is in the Standby mode and both of the aiming beam and the laser power can not be delivered to the patient 11 Mode Switch This switch will toggle between the Standby and Treat mode It gives the control of not only the treatment...

Page 54: ...he laser treatment Also another function will display the type of error code or warning 19 Counter Reset Switch LIO Intensity Activation Button Whenever this switch is pressed momentarily the total laser shot counter is reset to zero Another function is to activate the LIO intensity function by holding the key for one second or LIO wording display on the aiming intensity LED display Then the syste...

Page 55: ...p LDU it is possible to adjust the spot size and the beam position relative to the Slit lamp Illumination More detailed breakdown description of these delivery systems can be found below and next few pages VISIBLE LASER RADIATION AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION CLASS 4 IV LASER PRODUCT IEC60825 1 2007 SD3100 03 CAUTION DANGER 5 6 Inside 4 2 1 3 7 14 8 5 14 2 4 3 6 Figur...

Page 56: ...r looks through the eyepieces to view the patient The Interpupillary Distance can be adjusted as well as the individual s Diopter settings for each eyepiece 6 Doctor Safety Filter This safety filter is a standard set up in every Slit lamp LDU and is located at microscope housing This filter will prevent back reflections during laser treatment which may cause injury to the doctor s eyes Usually the...

Page 57: ... 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 Figure 4 10 a Front View of LIO LDU Controls Figure 4 10 b Top View of LIO LDU Controls 1 2 3 4 5 6 7 8 9 10 ...

Page 58: ...hysician or user There are three types of filters such as Red Free Heat Absorbing and Cobalt Blue 6 Optical Fiber The optical fiber connects between the LIO and the Laser Console The treatment and aiming beams are focused into the fiber 7 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 ...

Page 59: ... 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 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 ...

Page 60: ...TruScan 532 Single Wavelength Operators Manual Rev No 02 Page 59 of 114 CSO SL980 Slit lamp Controls continues Figure 4 11 SL980 Slit lamp Parts List and Controls ...

Page 61: ...s 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 Slit lamp 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 ...

Page 62: ...h 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 insta...

Page 63: ...LDU and Slit lamp 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 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 re...

Page 64: ...panel and arm holder 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 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...

Page 65: ...attern which allows clinician or physician to aim for the appropriate treatment location All the packaging items should be checked accordingly and unpacked carefully from their cartons and carry case Always inspect for any transportation damage and general condition and report any discrepancy or disclaim to freight courier if there is damage 5 4 1 System components TruScan 532 Single Wavelength pa...

Page 66: ...slowly tilt and plug in the inter power connectors refer to fig 5 3 and then fasten the eight bolt nuts using packed insert Allen key 4 Repeat the above step with right stand Note The power connections need to be facing each other refer to fig 5 4 5 Ensure the correct voltage setting is set correctly as default setting is set at 230VAC 0 2A refer to fig 5 5a d 6 Unpack the console bracket holder a...

Page 67: ...v No 02 Page 66 of 114 Figure 5 3 Inter power connection Right hand side Figure 5 4 Stands with power plugs facing each other Protecting Layer Power plugs Do not over stretch the cabling or connection because it may cause loosen connector Power plugs ...

Page 68: ...TruScan 532 Single Wavelength Operators Manual Rev No 02 Page 67 of 114 Voltage rate setting Fixation lamp connection ...

Page 69: ...elength Operators Manual Rev No 02 Page 68 of 114 Figure 5 5 a Rear view box connection Figure 5 5 b Removal fuse socket Slit lamp power source connection Power source connection Fixation lamp connection Voltage rate setting ...

Page 70: ...TruScan 532 Single Wavelength Operators Manual Rev No 02 Page 69 of 114 Figure 5 5 c Removal fuses Figure 5 5 d Voltage Setting Verification and Reinsert Back Process ...

Page 71: ...TruScan 532 Single Wavelength Operators Manual Rev No 02 Page 70 of 114 Figure 5 6 Final assembled product and verification recheck Up down motor movement Power switch control box ...

Page 72: ...y assembled table ass y and ensure the location is the final destination and well level 3 Assemble the slit lamp upper arm and lower base housings together by fasten the screw refer to 5 8 4 Carefully position the fully assembled slit lamp ass y over the rail and gently slide through the rails for the smoothness 5 Ensure the slit lamp ass y is horizontally in parallel axis realign if applicable an...

Page 73: ...ivery key plug and power switch key refer to fig 5 13a b 13 Position the arm rest and readjust if applicable 14 Mount the LCD panel holding arm by clamp down to the table top 15 Load the LCD panel to the arm by fasten the four screws located at the rear of panel and plug in all the appropriate connectors 16 Power on the LCD control panel and await for the system to boot up correctly then key switc...

Page 74: ...TruScan 532 Single Wavelength Operators Manual Rev No 02 Page 73 of 114 ...

Page 75: ...th Operators Manual Rev No 02 Page 74 of 114 Figure 5 8 Housing Screw location Figure 5 9 Assembled Upper and Lower Housings and organized Cabling Housing Screw Delivery Housing with Truscan integrated Binocular Joystick cabling ...

Page 76: ...an 532 Single Wavelength Operators Manual Rev No 02 Page 75 of 114 Figure 5 10 Cabling stuffed underneath of table top cabling gutter Figure 5 11 a Slit lamp arm ready for delivery housing Chrome Stop screw ...

Page 77: ...erators Manual Rev No 02 Page 76 of 114 Figure 5 11 b Delivery housing Fitting process Figure 5 12 Mounting Chinrest ass y and fiber holder and fitting delivery fiber to Truscan aperture Locking screw Fiber holder clamp Delivery fiber ...

Page 78: ...TruScan 532 Single Wavelength Operators Manual Rev No 02 Page 77 of 114 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 ...

Page 79: ...TruScan 532 Single Wavelength Operators Manual Rev No 02 Page 78 of 114 Figure 5 14 Clamp down the LCD Panel Holder in the middle of the gutter Figure 5 15 a Software System boot up ...

Page 80: ...TruScan 532 Single Wavelength Operators Manual Rev No 02 Page 79 of 114 Figure 5 15 b System Ready to operate ...

Page 81: ...e you through the entire pre check and alignment process Three different types of LDU systems are detailed as follows Slit lamp Integrated LIO Optional Endoprobe Optional A Integrated Slit lamp LDU Prior to pre check and realign the integrated Slit lamp LDU ensure all the corrected installation or setup are in placed including personal s dioptre setting fiber connection and console setup and on pr...

Page 82: ...for the Integrated Delivery Unit Slit lamp If not align realignment it refer to Service Manual section 6 3 slit lamp realignment procedures 4 Check the four filter wheel settings are ok and display accordingly 5 Validate the five aperture settings are functioning accordingly 6 Validate the slit fully opening and closing position functionality 7 Validate there is no illumination when slit is fully ...

Page 83: ...ing steps Procedures 1 Power on the console and ensure all the connection and connectors are in place refer to fig 5 16a Figure 5 16 a Fiber and Delivery Key fitted to Console Front Panel 2 Ensure the fiber tip head is cleaned by alcohol refer to below figure 5 16b Figure 5 16 b Fiber tips cleaning 3 Verify the aiming beam is being delivered correctly from LIO by shooting against the wall and set ...

Page 84: ...ion control knob refer to fig 5 16c Figure 5 16 c LCD LIO Intensity Control Figure 5 16 d LIO Control Knob 6 Verify the spot size or zoom system is accordingly from smallest to largest size 7 Ensure the different light aperture setting is also functioned accordingly refer to fig 5 16d 8 Ensure aiming spot light is able to tilt in up down position refer to fig 5 16d Light Aperture Setting Control A...

Page 85: ... are Straight P N 620009 Curved P N 620010 Ensure that Endoprobe coupling plug is well fitted prior to load to console laser aperture refer to fig 5 17 Figure 5 17 Endoprobe Coupling Plug Assembling Process In addition 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 ...

Page 86: ...leshooting section 8 3 Disengage the emergency button interlock plug in and plug in the key into keyhole and turn the key switch for power on the console 4 Validate if there is console establish communication with the LCD without any abnormality or error code process refer to troubleshooting section 8 otherwise proceed to next B Console Control Panel and Aiming Integrity Validation 5 Engage the Tr...

Page 87: ... 532 Single Wavelength Operators Manual Rev No 02 Page 86 of 114 6 1 Enter to spot calibration mode by double clicks the LIO icon 6 2 Enter passcode 777 6 3 Initial the Spot Size Calibration icon Double clicks ...

Page 88: ...hed 6 6 Save the value and validate it by rolling the zoom body vs the readout value 6 7 Exit and reset the console power 7 Ensure the spot vs the slit are aligned in the center position if not proceed to below procedures 7 1 Ensure the Ready mode is activated and set the spot position in 50um 7 2 Double clicks the LIO icon for accessing the calibration 7 3 Enter passcode 777 Initial Ready mode Do...

Page 89: ...tial the Home position and use the slit as the rule guide 7 5 Use the Up Down icon to move the spot toward the slit and repeat the process until the centering position is reached it 7 6 Save the value when it is completed it and exit it 7 7 Reset the console power and validate it ...

Page 90: ...ode and validate if the joystick able to move in the field of view proceed to next for further If the system rechecking process is valid then the system is ready to go More detailed screen operation and description refer to section 4 2 page 35 E Remote Control Verification Prior to commencing the final verification ensure all the corrected setup and equipment are in placed it Accessories Truscan C...

Page 91: ...gure 5 18 a Front End Connection Figure 5 18 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 5 18a Take special care when preparing the fiber to not stress the cable Hold the c...

Page 92: ...herwise proceed to next step 6 Initial the aiming intensity verification test refer to fig 5 20 Note Ensure the safety filter is installed prior trigger when firing the laser 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 19 a System boot up sequential display 1 Figure 5 19 b System boot up sequential ...

Page 93: ...switch LEDs lit 2 5 Slit is fully adjustable to closed position 2 6 Reset the columns by pressing down key to the end and columns integrity 2 7 Elevate the column to the max height lower again to validate the table 3 Slit lamp Check 3 1 Illumination lamp control checkout 3 2 Filters control checkout 3 3 Appecture settings control checkout 3 4 Slit centering opening and closing checkout 3 5 Slit ro...

Page 94: ...wer on the console and establish a communication without error or warming messages 6 4 All patterns functioning integrity validation 6 5 Aiming spot sizes validation 6 6 LCD touch screen integrity 6 7 All controls functioning integrity validation Installers Name ______________________ Date __________________ Distributor Name ______________________ Date __________________ Customer Name ____________...

Page 95: ...e The Retinal photocoagulation treatment it can use the Slit lamp Delivery unit As for the Pan retinal photocoagulation treatment it can use either the LIO or the Slit lamp 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 ord...

Page 96: ...orneal 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 ...

Page 97: ...ted 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 Binocular...

Page 98: ...ctory 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 this particular laser wavelength while the Laser unit is in use Outside the treatment room should be placed Laser warning signs or any appropriate warning signs for the ...

Page 99: ...ormal 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 The optical fibers that connect from the any all Laser Delivery units to the Laser Console must always be treated w...

Page 100: ...ssue 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 prolo...

Page 101: ...gnment 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 ope...

Page 102: ... beams are centered and focused in the center of the Illuminated spot There are adjustment screws for the Slit lamp 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 LDU s it is important that the delivered Laser beams are round in shape as this then means the align...

Page 103: ...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 Slit lamp Delivery the output power should be checked at both the 200µ and 1000µ spot size settings and for the...

Page 104: ... 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 Throughput Power Record Sheet Power Meter Model ____________ Serial Number ________________ Checked by __________________________ Date _________________ Delivery Unit type _________________________...

Page 105: ...lowing Symptom s Cause s Remedy action s No power no display Power failure Remote control panel connector not connected Check the power source or connector Check the power fuses Check the emergency button is outward ON position If the problem persists call the authorized service or manufacturer for further assistance No lamp illumination SD only No power to the lamp Lamp is burned out Check the la...

Page 106: ...eam Fiber is damage READY mode is not activated Output power not selected Laser cavity decayed Electronics malfunction Check the fiber integrity by replacing a new one Activate the READY mode Selected the specified power If the problem persists call the authorized service or manufacturer for further assistance ...

Page 107: ...n s Safety filter not found Safety filter not connect to the console or loosen with console Please connect the safety filter to the console Red diode temperature not ready Diode is not according to ambient temperature Please wait while the console adjusts itself according to ambient temperature This process may take up to five minutes to complete LBO temperature not ready LBO is not according to a...

Page 108: ...ivery key not fitted Delivery key is not inserted into console Please insert the correct delivery key into the console Communication failure Main program is wrong Please check the console state Contact your local service representative BRF temperature not ready BRF is not according to ambient temperature Please wait while the console adjusts itself according to ambient temperature This process may...

Page 109: ...e Laser system and make adjustments where possible 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 can be classified as 3 digits or 4 digits codes refer to fig 8 1 Figure 8 1 Sample of Error code display A complete listing of the TruScan 532 Single Wavelength error codes al...

Page 110: ... Failure Laser sensor failure opened or shorted sensor Power off call the authorized service or manufacturer for further assistance Err 5043 Cavity Temperature Out of Tolerance 2 5C Cavity Temperature sensor can not reach to the preset 2 5C Reboot the system If the problem persisted call the authorized service or manufacturer for further assistance Err 5044 Cavity Temperature Sensor Failure Cavity...

Page 111: ...nd console CPU Reboot the system Call the authorized service or manufacturer for further assistance Err 508 Calibration Error The system is uncalibrated Call the authorized service or manufacturer for further assistance Err 510 Watchdog Error System watchdog flag Reboot the system Call the authorized service or manufacturer for further assistance Err 5121 Power Too High The measured o p laser powe...

Page 112: ...manual is not serviced according to the instructions and procedures contained in the manual is subjected to misuse negligence or accidents is not installed according to the manufacturer instructions is connected to or used with accessories or spare parts that are not and have not been tested and approved by the Manufacturer The obligation of this warranty shall be limited to the repair or replacem...

Page 113: ...0 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 ...

Page 114: ...lt 20 Watt Prefocused with base Part Number 240012 Chinrest Papers Part Number 600026 Footswitch Part Number LCA903 Delivery Key Slit lamp 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 Int...

Page 115: ...TruScan 532 Single Wavelength Operators Manual Rev No 02 Page 114 of 114 ...

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Lightmed TruScan 532, Operator'S Manual

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