Lightmed TruScan Pro Operator'S Manual Download Page 9 | Manualshive

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LIGHTMED TruScan Pro

–

Operator’s Manual Rev. No. 01

Page

9

of

109

Section 2

Safety

This laser system has been designed and tested to function in a safe and correct operation when
used  as  indicated  in  this  manual.  Do  not  use  this  laser  without  reading  and  completely
understanding this Operator’s Manual. It is important to remember that this laser emits high levels
of visible and invisible laser radiation, which can cause permanent and irreparable eye and tissue
damages.  Always  observe  precautions  for  laser  safety  including  using  warning  signs,  safety
glasses,  and  only  operating  the  laser  in  a  treatment  room  that  provides  protection  to  casual
observers.

2.1

Product Classifications

The TruScan Pro Ophthalmic Laser is classified as:

•

Class IV laser product as specified in the standards IEC60825-1 (2007) as well as USA
21 CFR 1040.10 and 1040.11.

•

Class I type B electromedical equipment as specified in the IEC60601-1 standard.

•

Class II device according to the FDA CFR21 regulations.

•

Class II type B medical device according to the MDD 93/42/EEC (as amended by
2007/47/EC).

The TruScan Pro Ophthalmic Laser has been designed to comply with the following standards:

Standards

Description

Laser

•

IEC 60825-1:2014

•

EN 60825-1:2014

•

EN 60601-2-22:2013

•

IEC 60601-2-22:2007+A1:2012

Electrical

•

IEC 60601-1 3.1 Edition

•

EN 60601-1 3.1 Edition

•

IEC 60601-1-2 4th Edition

•

EN 60601-1-2 4th Edition

•

ANSI/AAMI 60601-1

Others

•

MDD 93/42/EEC (as amended by 2007/47/EC)

•

IEC 60601-1-6 Edition 3.1

•

EN 60601-1-6 Edition 3.1

•

IEC62366 Edition 3.1

•

EN62366 Edition 3.1

•

ISO 15223 :2016

•

EN ISO14971:2012

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Summary of Contents for TruScan Pro

Page 1: ...Operator sManual TruScan Pro ...

Page 2: ...LIGHTMED TruScan Pro Operator s Manual Rev No 01 Page 2 of 109 Operator s Manual For The TruScan Pro 2460 Directive 93 42 EEC Doc No DC1841 Rev No 01 ...

Page 3: ...ual contains confidential and proprietary information of the Manufacturer Copyright LIGHTMED Corporation Manufactured by LIGHTMED Corporation No 1 1 Lane 1 Sec 3 Pao An St Shulin District New Taipei City 23861 Taiwan ____________________________________________________________________________ USA Address 1130 Calle Cordillera San Clemente CA 92673 USA Telephone No 1 949 218 9555 Fax No 1 949 218 9...

Page 4: ...entification 20 Section 3 Product Specifications 21 3 1 Console Laser System Specifications 21 3 1 1 General Specifications 21 3 1 2 Treatment Laser Specifications 21 3 1 3 Aiming Laser Specifications 22 3 2 LDU Specifications 23 3 2 1 Slit Lamp Specifications 23 3 2 2 LIO Specifications 24 3 2 3 Endo ocular Probes Specifications 24 3 2 4 Safety Filter Specifications 25 3 2 5 Head up Display HUD S...

Page 5: ... 89 5 7 1 LCD Console Verification 89 5 7 2 Pattern Scanner Controls Verification 89 5 7 3 Micro Joystick Movement Verification 89 5 7 4 Output Power Verification 89 Output Power Record Sheet 91 Installation Report 92 Section 6 Clinical Use 95 6 1 LDUs in Clinical Use 95 6 2 Clinical Use General Warnings 96 6 3 Possible Side Effects or Adverse Reactions 97 Section 7 Troubleshooting 99 7 1 Error Sy...

Page 6: ...ver underneath the Tabletop 78 21 Feeding Remote Cable from the Console Cavity to the Tabletop 79 22 Routing the Cable and Fiber from the Slit Lamp 79 23 Screwing the Metal Cable Cover Plate Back onto the Tabletop 80 24 Attaching the Chinrest to the Tabletop 80 25 Slit Lamp and Chinrest Cable Management 81 26 Connecting the Slip Lamp Ground and Fixation Lamp Cables 81 27 Cable Management Ties 81 2...

Page 7: ...HTMED TruScan Pro Operator s Manual Rev No 01 Page 7 of 109 Record Sheet No Item Page 1 Output Power Record Sheet 90 2 Installation Report 91 Appendix No Item Page 1 Optional Accessories 106 2 Glossary 107 ...

Page 8: ...ot be held liable or responsible for damages or injury caused as a result of using unapproved accessories This includes all optical fiber systems laser delivery units LDU safety filters safety glasses and table units All maintenance and service work must be carried out by authorized and trained Service Technicians and only those procedures outlined in the Operator s and Service Manual are allowed ...

Page 9: ... The TruScan Pro Ophthalmic Laser is classified as Class IV laser product as specified in the standards IEC60825 1 2007 as well as USA 21 CFR 1040 10 and 1040 11 Class I type B electromedical equipment as specified in the IEC60601 1 standard Class II device according to the FDA CFR21 regulations Class II type B medical device according to the MDD 93 42 EEC as amended by 2007 47 EC The TruScan Pro ...

Page 10: ...nto READY mode until ready to operate on the patient DO NOT inhale any laser plume generated by the laser during surgery Personnel should take precautions such as wearing surgical masks or use plume evacuation systems when a treatment is undergoing o Caution Laser plume may contain viable tissue particulates ALWAYS take extra care of the optical fibers that connect the LDUs to the console to make ...

Page 11: ... NOHD specifies that the distance between the equipment and a patient s eye where the optical power from the equipment enters the dilated pupil of the patient should be less than or equal to the maximum permissible exposure MPE MPE as specified in the standards i e less than a Class I laser output The calculated NOHD for the TruScan Pro Laser with different LDUs is as follows LDU NOHD m Power Sett...

Page 12: ...al prongs for AC voltage where the third pin serves as the earth grounding prong WARNING It is not safe to operate the TruScan Pro laser without an earth grounding receptacle as there will be a possible risk of electrical shock No cover or housing will need to be removed by the operator or user Only authorized and trained Service Technicians will be allowed to remove the cover or housing assembly ...

Page 13: ... console Laser beam will only be delivered through this aperture if the fiber is securely and correctly attached 4 Delivery key connector Each LDU has its own unique delivery key that must be fitted into this socket to allow the microprocessor to recognize which LDU is being used Always make sure that the delivery key inserted corresponds to the LDU that is being used 5 AC outlet Provides power to...

Page 14: ...t turned on the microprocessor performs various checks to ensure that the laser is functioning properly If the self check test passes then the unit goes into STANDBY mode In addition to these safety features there are also several features that have been built in to the TruScan Pro laser system All the safety controls are in place to prevent the operator from unintentionally firing the laser This ...

Page 15: ... requirements of various regulatory standards that were previously mentioned 2 6 1 Console System All the safety and control labels on the console system are shown below Without 561um version With 561um version Figure 2 Laser console safety labels bottom panel Without 561um version With 561um version Figure 3 Laser console safety labels back panel ...

Page 16: ...horized representative in the European Community as per ISO 15223 1 3 Caution Indicates the need for the user to review the instructions for use for important cautionary information such as warnings and precautions that cannot for a variety of reasons be presented on the medical device itself as per ISO 15223 1 5 4 4 Indicates the optical fiber applicator as per IEC 60601 2 22 113 ...

Page 17: ...s per IEC 60417 2497 For indoor use only Indicates that this medical device is an electrical equipment designed primarily for indoor use as per IEC 60417 5957 Conformité Européene or European Conformity Indicates Manufacturer declaration that the product complies with the essential requirements of the relevant European health safety and environmental protection legislation as per 93 42 EEC Article...

Page 18: ...TMED TruScan Pro Operator s Manual Rev No 01 Page 18 of 109 2 6 2 Slit Lamp Laser Delivery Unit LDU All the safety and control labels on the slit lamp LDU are shown below Figure 4 Slit lamp LDU with labels ...

Page 19: ...LIGHTMED TruScan Pro Operator s Manual Rev No 01 Page 19 of 109 2 6 3 Laser Indirect Ophthalmoscope LIO LDU All the safety and control labels on the LIO LDU are shown below Figure 5 LIO LDU with labels ...

Page 20: ...ow Symbol Description This product requires a 100 volt current Laser radiation Laser radiation warning Power ON Power OFF Electronic copy of information on symbols for medical device Applied Part Type B Protective ground Caution Electrical shock Waste electrical and electronic equipment WEEE Product must be disposed of properly Serial number Optical fiber applicator ...

Page 21: ... to 1 100 Storage 10 to 55 Cooling system Fan cooled and thermoelectric cooling TEC for laser diode and crystal Dimensions Item Dimensions W x L x H mm System 370 x 330 x 13 Ophthalmic Table 920 x 630 x 1400 Portable Carrying Case 780 x 530 x 280 Weight Item Weight kg System 13 Packed 20 3 1 2 Treatment Laser Specifications Item Description Wavelength nm 532 561 577 670 810 Laser type OPSL DPSL OP...

Page 22: ... only Repeat interval Selectable from 10 to 10 000 ms and equal to or greater than exposure duration in same discrete steps as exposure duration SP mode Duty cycle selections 5 100 µs ON time 10 200 µs ON time 15 300 µs ON time 20 400 µs ON time 25 500 µs ON time for 810nm port2 only 30 600 µs ON time 31 3 626 µs ON time for 810nm port2 only 40 800 µs ON time Doctor safety filter OD4 OD6 Safety cl...

Page 23: ...it lamp focus plane Exposure duration ms Single spot 10 to 3 000 Multi spot 10 to 50 Repeat interval Single spot selectable from OFF 10 to 3 000 ms and greater than or equal to exposure duration in the same discrete steps as exposure duration Multi spot OFF Slit lamp The TruScan module is mounted between the binocular and objective lens Beam divergence Cone angle of 20 Magnification set 6 step dru...

Page 24: ...ixed filter OD4 Beam divergence Cone angle 20 Item Description Model Keeler Vantage Retinal spot size 1100µm 20 Measurement taken at 280mm from the front face of the LIO Illumination power From headset with LED illumination For other LIO models the illumination power is also available from laser console Internal PSU allows intensity adjustment Fiber length m 3 Weight Less than 500 g without laser ...

Page 25: ...escription Safety filters OD4 532 561 577 670 810 nm 3 2 5 Head up Display HUD Specifications Item Description Suitable for Installation IDS Delivery System Display Information Power Duration Interval Spot Size SP Mode Duty Total shots Interface Type C Dimensions 190 mm H x 122 mm W x 79 mm D Weight 520 g ...

Page 26: ...ications and contraindications before proceeding with any treatment Typically the operators or their assistants would verify that the laser and LDU are operating correctly before positioning the patient on the chinrest to avoid any inconvenience to the patient This verification process includes checking the laser output and alignment The operator must set the laser power and pulse interval wheneve...

Page 27: ... Slit lamp integrated into CSO model SL950 o Slit lamp attachment for CSO model SL950 and other Haag Streit models o Slit lamp attachment for Zeiss model SL30 slit lamp o LIO o Endo photocoagulation handpieces endoprobes 2 LCD screen Integrated with a computer platform For each LDU its unique delivery key needs to be plugged into the laser console for the system to determine which type of LDU is c...

Page 28: ...ient s eye These endoprobes are inserted into the eye and used in very close proximity to the treatment site almost in contact The endoprobes are sterile devise intended for direct patient contact and are purchased items with a sterility guarantee Most efficient LDU as the only energy losses occur in two places The coupling of the laser beam into the fiber Through the fiber itself This laser syste...

Page 29: ... The internal temperature takes less than 5 minutes to recalibrate itself For more details please refer to the Troubleshooting section of this manual 5 Once the self tests are completed the system software is displayed as shown in Figure 7 6 When the laser is turned ON it automatically goes into STANDBY mode to prevent any accidental firing of the selected laser wavelength In STANDBY mode the foot...

Page 30: ...be trained and possess knowledge in the intended use and application of the laser system in any surgical treatment sessions On top of that the laser system must be used in a clean and controlled environment When performing endophotocoagulation procedures a sterile surgical site should be enforced to reduce the risk of infection European National Requirements may apply in some EU countries and are ...

Page 31: ...otected by a login password upon system start up as shown in Figure 9 The user mode login password is 999 Figure 9 User mode login display Figure 10 User mode screen display divided into three panels The user mode screen display can be divided into three panels as follows 1 Menu bar 2 Console control panel 3 Pattern scanner panel ...

Page 32: ...n menu will appear when the is pressed as shown in Figure 11 Figure 11 Function option menu No Item Description 1 Delivery key display This display indicates the type of delivery key used slit lamp endo or LIO 2 Laser Lens display This display indicates the type of laser lens selected This selection can be customized as shown in the description of item no 10 ...

Page 33: ... or 577 nm yellow iii 670 nm red iv 810 nm infrared Three wavelengths in Port 1 or 2 i 532 nm green ii 561 nm yellow or 577 nm yellow iii 670 nm red Two wavelengths in Port 1 or 2 i 532 nm green ii 670 nm red One wavelength in Port 1 or 2 532 nm green 4 Function option menu This icon is used to open the selection menu Inactive Activated 5 Volume The two up and down arrows control the volume of the...

Page 34: ...or parameters Inactive Activated 8 User manual This button showcases user manual 9 Treatment report This function will create a new patient report The user can enter the patient s personal information and parameters used in the treatment The report can be printed or uploaded to a DICOM server by pressing the Setting button Inactive Activated ...

Page 35: ...n the OFF position Press X to close the window ii Press New on the Report menu A new treatment report window will pop up When the DICOM is OFF the patient fileds in the treatment report window will be empty and the laser settings fields will be autogenerated All fields can be modified by the user iii The user can also draw and visualize the treatment area on the treatment report iv Insert the USB ...

Page 36: ...n the Report menu ii Make sure that the DICOM Server Setting is in the ON position iii Press on the Edit pencil button to enter the IP address application entity AE title and port number iv After editing click the Test Connection and wait for the Success message to pop up v On the Report menu press New button Enter the Patient ID ...

Page 37: ... and a Save Successfully window will be prompted when the report is sucessfully saved 10 Custom contact lens list The user can add and modify the contact lens list that is readily available in the system to fit their treatment preferences Four contact lens options can be stored in the preferred contact lens list Inactive Activated ...

Page 38: ...𝑢𝑒𝑛𝑐𝑒 𝐸𝑛𝑒𝑟𝑔𝑦 𝐴𝑟𝑒𝑎 𝑃𝑜𝑤𝑒𝑟 1 000 𝐷𝑢𝑟𝑎𝑡𝑖𝑜𝑛 1 000 𝜋 𝑆𝑝𝑜𝑡 𝑠𝑖𝑧𝑒 1 000 2 The fluence is automatically recalculated when any contact lens field changes 11 Theme color This function changes the user interface color The colors available are black blue and purple Inactive Activated 12 Brightness The brightness control bar has a slider that adjusts the brightness of the screen display Inactive Activated 13 Off...

Page 39: ...EADY mode and both the aiming beam and laser power can be delivered to the patient once the footswitch is pressed 2 STANDBY Inactive The system is in READY mode and both the aiming beam and laser power can be delivered to the patient once the footswitch is pressed Activated The system is in STANDBY mode where both the aiming beam and laser power are disabled The system will automatically go into S...

Page 40: ... intensity can be adjusted with the two up and down arrows 8 Aiming beam intensity display Displays the brightness of the aiming beam At the maximum brightness the output power is around 1 0 mW or less to the patient s cornea 9 Software version Displays the current software version 10 Spot size on retina Displays the spot size on patient s retina in µm 11 Spot size display Displays the spot size i...

Page 41: ...erval controls The exposure interval which is the time between each laser pulse is adjustable using the two up and down arrows The minimum interval is 10 ms and the maximum is 3 000 ms If the interval is adjusted below 10 ms then the interval will display OFF and the laser will only fire once per footswitch press 15 Duration display Displays the laser exposure duration in ms 16 Power display Displ...

Page 42: ...adius between the circular arc and curvature patterns The radius can be adjusted to 1 000 1 500 or 2 000 µm 3 Pattern spacing Adjusts the spacing between two dots on any pattern The maximum spacing rate is triple 3x the original size and the minimum spacing rate would mean the original pattern spacing 4 Pattern rotation Rotates the pattern by 5 clockwise 5 Joystick icon Inactive The joystick is in...

Page 43: ...150 ms o 200 to 3 000 ms in 100 ms increments o 3 500 to 5 000 ms in 500 ms intervals and 10 000 ms 810nm only 7 Straight line pattern Spot size µm 100 to 500 Spacing Φ 0 0 5 0 75 1 0 1 5 1 75 2 0 Rotation 0 to 355 in 5 increments 8 Square pattern Spot size µm 100 to 500 Spacing Φ 0 0 5 0 75 1 0 1 5 1 75 2 0 Rotation 0 to 355 in 5 increments 9 Triangle pattern Spot size µm 100 to 500 Spacing Φ 0 0...

Page 44: ...s Manual Rev No 01 Page 44 of 109 1 0 15 dots 23 dots 1 5 12 dots 18 dots 25 dots 2 0 10 dots 15 dots 21 dots 300 0 20 dots N A 0 5 13 dots 21 dots 28 dots 0 75 11 dots 18 dots 24 dots 1 0 10 dots 16 dots 21 dots 1 5 8 dots 13 dots ...

Page 45: ... Manual Rev No 01 Page 45 of 109 17 dots 2 0 7 dots 11 dots 14 dots 400 0 16 dots 24 dots 30 dots 0 5 11 dots 16 dots 20 dots 0 75 9 dots 14 dots 17 dots 1 0 8 dots 12 dots 15 dots 1 5 6 dots 10 dots 12 dots 2 0 5 dots 8 dots 10 dots ...

Page 46: ... dots 18 dots 24 dots 0 5 8 dots 12 dots 16 dots 0 75 7 dots 10 dots 14 dots 1 0 6 dots 9 dots 12 dots 1 5 5 dots 7 dots 10 dots 2 0 N A 6 dots 8 dots circle parameters rotation can be adjusted from 0 to 355 in 5 increments Spot Size µm Spacing Φ Radius µm 1 000 1 500 2 000 ...

Page 47: ...tor s Manual Rev No 01 Page 47 of 109 200 0 15 dots 23 dots N A 0 5 10 dots 16 dots 21 dots 0 75 9 dots 13 dots 18 dots 1 0 8 dots 12 dots 16 dots 1 5 6 dots 9 dots 13 dots 2 0 5 dots 8 dots 11 dots 300 0 10 dots 16 dots 21 dots ...

Page 48: ...o Operator s Manual Rev No 01 Page 48 of 109 0 5 7 dots 11 dots 14 dots 0 75 6 dots 9 dots 12 dots 1 0 5 dots 8 dots 11 dots 1 5 4 dots 7 dots 9 dots 2 0 4 dots 6 dots 7 dots 400 0 8 dots 12 dots 15 dots 0 5 6 dots 8 dots ...

Page 49: ...ruScan Pro Operator s Manual Rev No 01 Page 49 of 109 10 dots 0 75 5 dots 7 dots 9 dots 1 0 4 dots 6 dots 8 dots 1 5 3 dots 5 dots 6 dots 2 0 N A 4 dots 5 dots 500 0 6 dots 9 dots 12 dots 0 5 4 dots 6 dots 8 dots ...

Page 50: ...f 109 0 75 N A 7 dots 1 0 3 dots 5 dots 6 dots 1 5 3 dots 4 dots 5 dots 2 0 N A 3 dots 4 dots circle parameters rotation can be adjusted from 0 to 355 in 5 increments Spot Size µm Spacing Φ Radius µm 1 000 1 500 2 000 200 0 23 dots N A 0 5 15 dots 24 dots N A ...

Page 51: ...can Pro Operator s Manual Rev No 01 Page 51 of 109 0 75 13 dots 20 dots 27 dots 1 0 12 dots 18 dots 24 dots 1 5 9 dots 14 dots 19 dots 2 0 8 dots 12 dots 16 dots 300 0 15 dots 24 dots N A 0 5 10 dots 16 dots 21 dots ...

Page 52: ...Scan Pro Operator s Manual Rev No 01 Page 52 of 109 0 75 9 dots 14 dots 18 dots 1 0 8 dots 12 dots 16 dots 1 5 6 dots 10 dots 13 dots 2 0 N A 9 dots 11 dots 400 0 12 dots 18 dots 23 dots 0 5 9 dots 12 dots 15 dots ...

Page 53: ...n Pro Operator s Manual Rev No 01 Page 53 of 109 0 75 7 dots 11 dots 13 dots 1 0 6 dots 9 dots 12 dots 1 5 5 dots 8 dots 9 dots 2 0 4 dots 6 dots 8 dots 500 0 9 dots 14 dots 18 dots 0 5 6 dots 9 dots 12 dots 0 75 N A ...

Page 54: ... 1 0 5 dots 7 dots 9 dots 1 5 4 dots 6 dots 8 dots 2 0 3 dots 5 dots 6 dots circle parameters rotation can be adjusted from 0 to 355 in 5 increments Spot Size µm Spacing Φ Radius µm 1 000 1 500 2 000 200 0 8 dots 12 dots 16 dots 0 5 5 dots 8 dots 11 dots 1 0 4 dots 6 dots 8 dots ...

Page 55: ...n Pro Operator s Manual Rev No 01 Page 55 of 109 1 5 3 dots 5 dots 7 dots 2 0 3 dots 4 dots 6 dots 300 0 5 dots 8 dots 11 dots 0 5 4 dots 6 dots 7 dots 1 0 3 dots 4 dots 6 dots 1 5 N A 4 dots 5 dots 2 0 3 dots 4 dots ...

Page 56: ...TruScan Pro Operator s Manual Rev No 01 Page 56 of 109 400 0 4 dots 6 dots 8 dots 0 5 3 dots 4 dots 5 dots 1 0 N A 3 dots 4 dots 1 5 3 dots 3 dots 2 0 N A 3 dots 500 0 3 dots 5 dots 6 dots 0 5 N A 3 dots 4 dots ...

Page 57: ...09 1 0 3 dots 3 dots 1 5 N A 3 dots 11 Arc pattern Triple arc rings Double arc rings Triple arc rings parameters rotation can be adjusted from 0 to 355 in 5 increments Spot Size µm Spacing Φ Radius 1 000 µm 200 1 0 18 dots 1 5 15 dots 2 0 13 dots 300 1 0 13 dots ...

Page 58: ...58 of 109 1 5 11 dots 2 0 9 dots Double arc rings parameters rotation can be adjusted from 0 to 355 in 5 increments Spot Size µm Spacing Φ Radius µm 1 000 1 500 200 1 0 10 dots 14 dots 1 5 8 dots 12 dots 2 0 7 dots 10 dots 300 1 0 7 dots 10 dots 1 5 6 dots ...

Page 59: ...0 5 dots 7 dots 400 1 0 5 dots 7 dots 1 5 5 dots 6 dots 2 0 N A 5 dots 12 Curvatur e pattern Single curve Triple curve Single curve parameters rotation can be adjusted from 0 to 355 in 5 increments Spot Size µm Spacing Φ Radius µm 1 000 1 500 2 000 200 0 19 dots 31 dots N A ...

Page 60: ...LIGHTMED TruScan Pro Operator s Manual Rev No 01 Page 60 of 109 0 5 13 dots 21 dots 0 75 11 dots 19 dots 1 0 9 dots 17 dots 1 5 7 dots 13 dots 2 0 7 dots 11 dots ...

Page 61: ...LIGHTMED TruScan Pro Operator s Manual Rev No 01 Page 61 of 109 300 0 13 dots 23 dots 0 5 9 dots 15 dots 0 75 7 dots 13 dots 1 0 7 dots 11 dots 400 0 11 dots 17 dots 237 dots ...

Page 62: ...LIGHTMED TruScan Pro Operator s Manual Rev No 01 Page 62 of 109 0 5 7 dots 11 dots 15 dots 0 75 5 dots 9 dots 13 dots 1 0 5 dots 9 dots 11 dots 500 0 9 dots 13 dots 19 dots ...

Page 63: ... 01 Page 63 of 109 0 5 5 dots 9 dots 13 dots 0 75 5 dots 9 dots 11 dots 1 0 5 dots 7 dots 9 dots Triple curve parameters rotation can be adjusted from 0 to 355 in 5 increments Spot Size µm Spacing Φ Radius µm 1 000 1 500 2 000 200 1 0 27 dots N A ...

Page 64: ...LIGHTMED TruScan Pro Operator s Manual Rev No 01 Page 64 of 109 1 5 21 dots 2 0 21 dots 300 1 0 21 dots 400 1 0 15 dots 27 dots N A 500 0 27 dots 39 dots 57 dots ...

Page 65: ...dots 39 dots 0 75 15 dots 27 dots 33 dots 1 0 15 dots 21 dots 27 dots 13 Rhombu s pattern Rhombus pattern parameters rotation can be adjusted from 0 to 355 in 5 increments Spo t Size µm Spacin g Φ Radius µm N A 100 0 4 dots 9 dots 16 dots 25 dots 0 5 4 dots 9 dots 16 dots 25 dots ...

Page 66: ...dots 25 dots 1 0 4 dots 9 dots 16 dots 25 dots 1 5 4 dots 9 dots 16 dots 25 dots 1 75 4 dots 9 dots 16 dots 25 dots 2 0 4 dots 9 dots 16 dots 25 dots 200 0 4 dots 9 dots 16 dots 25 dots 0 5 4 dots 9 dots 16 dots 25 dots 0 75 4 dots 9 dots 16 dots 25 dots 1 0 4 dots 9 dots 16 dots 25 dots ...

Page 67: ...e 67 of 109 1 5 4 dots 9 dots 16 dots 25 dots 1 75 4 dots 9 dots 16 dots 25 dots 2 0 4 dots 9 dots 16 dots 25 dots 300 0 4 dots 9 dots 16 dots 25 dots 0 5 4 dots 9 dots 16 dots 25 dots 0 75 4 dots 9 dots 16 dots 25 dots 1 0 4 dots 9 dots 16 dots 25 dots ...

Page 68: ...ual Rev No 01 Page 68 of 109 1 5 4 dots 9 dots 16 dots 25 dots 1 75 4 dots 9 dots 16 dots 25 dots 2 0 4 dots 9 dots 16 dots 25 dots 400 0 4 dots 9 dots 16 dots 25 dots 0 5 4 dots 9 dots 16 dots 25 dots 0 75 4 dots 9 dots 16 dots 25 dots ...

Page 69: ...nual Rev No 01 Page 69 of 109 1 0 4 dots 9 dots 16 dots 25 dots 1 5 4 dots 9 dots 16 dots 25 dots 1 75 4 dots 9 dots 16 dots 25 dots 2 0 4 dots 9 dots 16 dots 25 dots 500 0 4 dots 9 dots 16 dots 25 dots 0 5 4 dots 9 dots 16 dots 25 dots ...

Page 70: ...Pro Operator s Manual Rev No 01 Page 70 of 109 0 75 4 dots 9 dots 16 dots 25 dots 1 0 4 dots 9 dots 16 dots 25 dots 1 5 4 dots 9 dots 16 dots 25 dots 1 75 4 dots 9 dots 16 dots 25 dots 2 0 4 dots 9 dots 16 dots 25 dots ...

Page 71: ...ccessory The 3D mouse controls are described below Control Description Rotate the black top of the 3D mouse Rotates the chosen pattern Slide the black top of the 3D mouse to the left or right Toggles between all the pattern groups in the pattern selection process highlighted in red below A single push onto the black top of the 3D mouse Toggles between the different patterns within a pattern group ...

Page 72: ...chosen pattern from 0 to 2 0 Φ Tilt the black top of the 3D mouse towards the top right direction Changes decrease or increase the radius of a chosen pattern Press the two buttons on the sides of the 3D mouse Toggles between the Power Duration Interval Aiming Beam Intensity controls Button 1 decreases the value of each selected control Button 2 increases the value of each selected control ...

Page 73: ...t laser and aiming beams are focused into the fiber 2 Zoom system and TruScan housing The pattern visuals are generated through the two high speed scanning motors in this item Laser beam spot size can be adjusted from 50 to 1 000 µm by rotating the control The spot size is reflected on the pattern display area on the LCD screen 3 Objective lens The laser beam is focused by this lens to be delivere...

Page 74: ...n to install a portable additional safety filter It prevents back reflections during laser treatment subsequently minimizes the risk of injury to the user s eyes The orange filter provides protection as follows OD4 577 670 532 561 810 nm 6 Binoculars and eyepieces The user views the treatment site via the binoculars and eyepieces The interpupillary distance and the user s unique diopter settings c...

Page 75: ...e phase outlet capable of delivering up to 400 W A mains power cable is supplied but the connector may not suit the outlet that is available in the treatment room It is recommended to have a spare locally compatible cable available The cable assembly must be CE approved for use in EU countries It is recommended that the main power cable of the ophthalmic table be plugged into multiple portable soc...

Page 76: ...Scan console Upon receiving the system please inspect the packing carton for signs of mishandling which must be reported to the freight handler before the instrument is unpacked If the damage that occurred during transport is not reported the Manufacturer reserves the right to decline any warranty claims The freight company shall take full responsibility for any damage occurred during transport If...

Page 77: ...hermal paper Zap It or equivalent o A set of Allen keys metric o Phillips or Robertson screwdrivers Laser power meter to measure from 0 to 3 W 5 4 Installation Process The TruScan Pro laser system consists of the following functional units that need to be assembled by a trained and authorized Service Technician or installer Ophthalmic table TruScan module integrated CSO SL950 slit lamp 10 inch LCD...

Page 78: ... 5 The cover is held on by tabs that are inserted into their respective holes Remove the left console cover by pushing it first towards the back of the table to release the tabs from its respective holes and then push the cover towards the left hand side to remove it completely from the table the internal wiring components will be exposed Figure 19 Figure 19 Removing the cover from the table 6 Mak...

Page 79: ...screwdriver to remove the left metal cable cover plate on the tabletop the cable cover plate closest to the table column Lift the slit lamp and make sure to carefully route the cable and fiber to the left side towards the table column Figure 22 Figure 22 Routing the cable and fiber from the slit lamp 10 Secure a cable tie around the cable and fiber Place the cable tie onto the notch on the tableto...

Page 80: ...5 mm hex wrench to secure the four screws underneath the tabletop to secure the chinrest to the tabletop Figure 24 Figure 24 Attaching the chinrest to the tabletop 12 Route the cables and fiber from the slit lamp and chinrest through the left hole the hole closest hole to the table column underneath the tabletop for cable management Figure 25 ...

Page 81: ... to their respective counterparts following the labels tagged on them Route the slit lamp cable and fiber through the second hole facing the table column Figure 26 Figure 26 Connecting the slit lamp ground and fixation lamp cables 14 Secure the cables by using the white adjustable cable management ties that stick to the tabletop Figure 27 Figure 27 Cable management ties ...

Page 82: ... Cable management spine 16 Equip the tabletop cable cover by using a 2 mm hex wrench to secure the six screws underneath the tabletop Locate the indent between the tabletop and cable cover near the column This is the location where the 10 inch LCD screen will be mounted To loosen the mount clamp turn the knob on the mount counterclockwise To tighten it turn the knob clockwise Figure 29 Figure 29 M...

Page 83: ...Figure 31 Connect all the LCD screen cables Secure the LCD cable covers back Figure 31 Connecting LCD screen cables 19 To mount the laser console to the console holder first pull the hanger outwards from the hanger cavity Note that there are three circular holes that are set in the configuration that matches the circular hooks on the back of the laser console Next mount the laser console to the ha...

Page 84: ...the stopper Figure 34 Figure 34 Releasing console hanger from the stopper 22 With the hanger released from its stopper the hanger can now be pushed back into the hanger cavity putting the laser console in place inside the console cover Figure 35 Figure 35 Pushing the console hanger back into the hanger cavity 23 Locate the tab on the fiber assembly This tab must be positioned accordingly into the ...

Page 85: ...y for fiber assemblies while Port 2 is catered to the LIO assembly Figure 36 Inserting the fiber assembly into Port 1 of the laser console 24 Connect the main power cable to the inlet on the right console holder cover Figure 37 Plug in the interlock key Press the power switch to turn the table ON Figure 37 Turning the system ON 25 The installation for the ophthalmic table is completed Figure 38 Co...

Page 86: ...tor s Manual Rev No 01 Page 86 of 109 5 5 HUD Installation Process 1 Remove the Binoculars and the screw 2 Secure screw on the right hand side to mount and fix the HUD module on the IDS 3 Connect the Type C cable from HUD to IDS ...

Page 87: ...lamp the optical alignment of the laser beam needs to be checked and adjusted in reference to the slit lamp optical alignment The three LDUs mentioned are LIO optional Endoprobe optional 5 6 1 LIO Optional Alignment Figure 39 LIO assembly 1 Turn the laser console ON 2 Ensure that the fiber tip is cleaned with alcohol prior to connecting it to the laser console Figure 40 ...

Page 88: ...rify that the spot size or zoom system is in correct configuration from the smallest to largest size 8 Ensure that the different light aperture setting and the aiming beam position are functioning properly Figure 41 Figure 41 LIO control knobs 5 6 2 Endoprobe Optional Alignment 1 The Endoprobe is a sterilized single use device so no installation is needed However verification is required to ensure...

Page 89: ...system to boot up 4 Verify if the console has established communication with the LCD screen without any abnormalities or error codes 5 7 2 Pattern Scanner Controls Verification 1 Click the square pattern 5x5 and verify that the patterns are evenly distributed in x and y axes Otherwise refer to the Service Manual 2 Verify that all controls in the pattern scanner controls screen are functional 5 7 3...

Page 90: ...l output power reading on the power meter Ensure that the reading on the power meter is multiplied by two as the laser is fired at 50 duty cycle to obtain the true output power value For slit lamp LDU the output power should be checked at both 200 and 1 000 µm spot sizes Ensure that the slit lamp illumination tower is pushed to one side to avoid blocking ant part of the laser beam For attachment L...

Page 91: ...Green White Slit Aperture 0 3 6 10 13 mm Continuous Slit Width 100 Open 4 SYSTEM DETAILS N A if not applicable Laser Console Product Name Wavelength s 532 nm 561 nm 577 nm 670 nm 810 nm Laser Console S N SHG Temprature ___________ C BRF Temperature ___________ C Case Temperature ___________ C Warranty Yes No Warranty Expiry Date Table Type Table S N Column S N Console Software Cal Mode PC Software...

Page 92: ...the slit is fully closed 7 A narrow slit can rotate 90 vertically 8 Eyepieces fit firmly into binoculars 9 Eyepieces can be fully adjusted and set to correct diopters 10 Vertical slit lamp movement with joystick checks OK 11 Side slit lamp movement with joystick checks OK 12 Forward slit lamp movement with joystick checks OK 13 Slit lamp movements with joystick are smooth no tension or friction 14...

Page 93: ...100 40 60 500 200 300 700 280 420 1 000 400 600 9 TRANSMISSION CALIBRATION 20 TOLERANCE Duration 0 05 s Interval 0 05 s Wavelength nm Display Power mW Power Meter Reading mW x2 Min Max mW PASS FAIL ADJUSTED N A 532 50 40 60 100 200 300 250 280 420 561 50 40 60 100 200 300 250 280 420 577 50 40 60 100 200 300 250 280 420 670 50 40 60 100 200 300 250 280 420 810 50 40 60 100 200 300 250 280 420 10 C...

Page 94: ...LIGHTMED TruScan Pro Operator s Manual Rev No 01 Page 94 of 109 Installation Report INTERNAL USE ONLY RMA Number Service Order Number Reviewer Name Date Reviewed Notes ...

Page 95: ...roinfarction or capillary closure Uses the Endoprobe Should be practiced in a sterile environment 4 Macular treatments Involves the destruction of leaking vessels in the macular and paramacular regions in order to produce a chorioretinal adhesion that can resist ongoing vitreoretinal traction Uses the slit lamp LDU 5 Laser trabeculoplasty Photocoagulation of the trabecular meshwork to create apert...

Page 96: ...inal sites To perform platelet rich plasma PRP in proliferative diabetic retinopathy To perform intraoperative PRP on a scleral buckle To perform intraoperative PRP around focal neovascularization Do not treat albino patients or eyes that have no pigmentation 6 2 Clinical Use General Warnings Doctors should ensure that they have extended training before attempting to carry out any of the indicated...

Page 97: ...er for treatment always keep the aiming beam in a good focus so that the resultant tissue effect is clinicallysatisfactory The laser beam divergence from the Endoprobe is higher in air than in a fluid medium When using the Endoprobe in air a higher power setting is required to get an equivalent burn as seen on the retina at a given distance When using the LIO always ensure that the headpiece is ad...

Page 98: ... the patient should be monitored and treated accordingly if this is a potential issue 6 Venous pressure Patients should be cautioned against performing any activity that could increase their venous pressure in their head or eyes Avoid rubbing the eyes blowing the nose and prolonging sneezing or coughing The head should be slightly elevated during sleep while recovering from the treatment For this ...

Page 99: ...ight up SD only No power to the illumination lamp Illumination lamp is burned out Verify the illumination lamp voltage 12 Check the illumination lamp integrity Verify that there is no dust and or fingerprint on the LED 3 No aiming beam SD only Aiming beam intensity needs to be calibrated Aiming beam electric circuit failure Reboot the system 4 No low energy output for the green yellow red or infra...

Page 100: ...lease wait while the console adjusts itself 7 LASER DIODE 532 BRF TEMPERATURE UNDER REGULATION Laser diode 532 BRF temperature is above or below 3 C 8 LASER DIODE 532 CASE TEMPERATURE UNDER REGULATION Laser diode 532 case temperature is above or below 3 C 9 LASER DIODE 577 SHG TEMPERATURE UNDER REGULATION Laser diode 577 SHG temperature is above or below 3 C 10 LASER DIODE 577 BRF TEMPERATURE UNDE...

Page 101: ...airs Refer to Section 9 for warranty details and conditions The error codes of the TruScan system are typically in the 3 or 4 digit format as shown in Figure 49 below Figure 44 Error code example A complete list of the error codes for TruScan Pro laser system is as follows If any of these symptoms persists please call the Manufacturer or local authorized Service Engineer No Error Code Description ...

Page 102: ...rature regulation is above or below 10 C over 5 minutes 13 Err 5048 Laser diode 810 case temperature regulation is above or below 10 C over 5 minutes 14 Err 5082 Flash memory error 7 4 3D Mouse Error Symptoms If the 3D mouse is not able to carry out any actions during the normal operation of the laser system please refer to the list below No Error Symptoms Description Corrective Actions 1 Not work...

Page 103: ...LIGHTMED TruScan Pro Operator s Manual Rev No 01 Page 103 of 109 ii Select Properties iii Click Buttons iv On the LEFT option click the arrow select TruScanPro select Left View ...

Page 104: ...LIGHTMED TruScan Pro Operator s Manual Rev No 01 Page 104 of 109 v On the RIGHT option click the arrow select TruScanPro select Right View ...

Page 105: ...ufacturer in order to decide on a suitable course of action Refer to Section 9 of this Manual for specific national requirements for EU countries The following procedures are recommended by the Manufacturer for the user to follow 1 Clean the external surfaces of the laser using a damp but not dripping cloth Use a mild cleaning agent and do not use any solvents Do not spray or pour any cleaning age...

Page 106: ...o the instructions and procedures mentioned in this Manual Is subjected to misuse negligence or accidents Is not installed according to the Manufacturer s instructions Is connected to or used with accessories or spare parts that are not and have not been tested and approved by the Manufacturer The obligation of this warranty shall be limited to the repair or replacement at the Manufacturer s recom...

Page 107: ...Tube 600426 7 Endoprobes Straight 20 Gages PD720 10 8 Endoprobes Curved 20 Gages PD720 20 9 Endoprobes Curved 23 Gages PD723 10 10 Endoprobes Curved 23 Gages PD723 20 11 Endoprobes Curved 25 Gages PD725 10 12 Endoprobes Curved 25 Gages PD725 20 13 Straight Endoprobes Illuminate PD723 30A 14 Curved Endoprobes Illuminate PD723 35A 15 Endoprobes Aspirating PD720 60 The following are spare part access...

Page 108: ...livery system IOL Intraocular lens LBO Lithium triborate LCD Liquid crystal display LDU Laser delivery unit LIO Laser indirect ophthalmoscope MCU Microcontroller unit MPE Maximum permissible exposure NOHD Nominal ocular hazard distance OD Optical density OPSL Optically pumped solid state laser PM Preventive Maintenance PRP Platelet rich plasma SHG Second harmonic generation TEC Thermoelectric cool...

Page 109: ...LIGHTMED TruScan Pro Operator s Manual Rev No 01 Page 109 of 109 ...

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