Iridex PASCAL Synthesis TwinStar Operator'S Manual Download Page 118

Page: 118 / 142

PASCAL

Synthesis TwinStar Ophthalmic Scanning Laser Systems

Page 118 of 142

88293-EN, Rev C

Code

Message

Critical

Clearable

Warning

Description

Action

Red 200µm Treatment
Local Light Over
(High)

Laser output is 100% over the
expected value

User to select End
Treatment and Return to the
Home Screen. Re-access
treatment screen and
reconfigure treatment
parameters.
If error repeats-End
Treatment and call Service

Unexpected local light
(OPSL Aiming)

Laser output was detected when it
was not expected

Verify device connections.

Unexpected local light
(Red 60µm)

Laser output was detected when it
was not expected

Verify device connections.

Unexpected local light
(Red 200µm)

Laser output was detected when it
was not expected

Verify device connections.

X-Galvo Spot Position
Service Error During
Aiming

An error occurred within the spot
position service regarding the X
galvo during aiming beam output

Clear error to continue.
Call service if error persists.

Y-Galvo Spot Position
Service Error During
Aiming

An error occurred within the spot
position service regarding the Y
galvo during aiming beam output

Clear error to continue.
Call service if error persists.

X-Galvo Spot Position
Service Error During
Treatment

An error occurred within the spot
position service regarding the X
galvo during treatment output

Clear error to continue.
Call service if error persists.

Y-Galvo Spot Position
Service Error During
Treatment

An error occurred within the spot
position service regarding the Y
galvo during treatment output

Clear error to continue.
Call service if error persists.

Spot Size Service F-
Galvo

An error occurred within the spot
size service regarding the F galvo

Clear error to continue
Call service if error persists.

Software Watchdog

Main PCB controller has been reset
or did not synchronize with the
SBC.

Reboot.
Call service if error persists.

Host Communication

Communication with the SBC
failed.

Reboot.
Call service if error persists.

Port 1 Fault

An error was detected with port 1

Reboot.
Call service if error persists.

Summary of Contents for PASCAL Synthesis TwinStar

Page 1: ...n Obelis 1212 Terra Bella Avenue Boulevard G n ral Wahis 53 Mountain View CA 94043 1030 Brussels USA Belgium Office 1 650 940 4700 Phone 32 2 732 59 54 Fax 1 650 962 0486 Fax 32 2 732 60 03 www iridex...

Page 2: ...PASCAL Synthesis TwinStar Ophthalmic Scanning Laser Systems Page 2 of 142 88293 EN Rev C Intentionally left blank...

Page 3: ...aw Copying includes translation into another language Please note that while every effort has been made to ensure that the data given in this document is accurate the information figures illustrations...

Page 4: ...PASCAL Synthesis TwinStar Ophthalmic Scanning Laser Systems Page 4 of 142 88293 EN Rev C Intentionally left blank...

Page 5: ...aser System is intended for use to perform single spot photocoagulation in the posterior segment retina choroid and in the anterior segment iris trabecular meshwork as well as pattern scanning photoco...

Page 6: ...leshooting maintenance and cleaning Please refer to this operator manual for instructions and guidance on how to appropriately use your laser Before using the system carefully read CAUTION WARNING and...

Page 7: ...es 26 Ophthalmic Applications 27 Contraindications 29 Potential Complications or Side Effects 29 Adverse Effects and Complications 30 Posterior Segment Laser Procedures 30 Anterior Segment Laser Proce...

Page 8: ...uses 104 System Specifications 105 Troubleshooting Guide 108 Error Messages 112 Error States 112 Calibration Procedure 122 Disclaimer Warning 122 Calibration Instructions 122 System Relocation Instruc...

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Page 10: ...PASCAL Synthesis TwinStar Ophthalmic Scanning Laser Systems Page 10 of 142 88293 EN Rev C CAUTIONS WARNINGS...

Page 11: ...nce Training course on the appropriate laser system Adjustment by anyone other than Iridex Corporation certified personnel or by customers who have taken and passed a Bio Medical Preventative Maintena...

Page 12: ...es Laser Emission Warning PASCAL Synthesis TwinStar System Information Label includes Manufacturer Part Number Serial Number Manufacture Date Follow operating instructions WEEE Directive Type B applie...

Page 13: ...inStar 577 nm 638 nm Danger label includes Laser Emission Warning Wavelength Power Laser Class USB Connections Wireless USB Caution Remote Door Interlock Connection Footswitch Connection I ON O OFF La...

Page 14: ...ASCAL Synthesis TwinStar Ophthalmic Scanning Laser Systems Page 14 of 142 88293 EN Rev C General Warning Label Additional Labels Footswitch Ingress Protection Hospital Grade Cord Grounding Instruction...

Page 15: ...PASCAL Synthesis TwinStar Ophthalmic Scanning Laser Systems Page 15 of 142 88293 EN Rev C Intentionally left blank...

Page 16: ...The systems have undergone extensive testing With proper handling they are useful and reliable clinical instruments To protect operating personnel and patients this safety section and the appropriate...

Page 17: ...hat the system is capable of emitting laser energy Appropriate precautions such as wearing appropriate eyewear in the room should be taken As a precaution against accidental exposure to the output bea...

Page 18: ...level of direct reflected or scattered radiation during normal operation is not expected to exceed the applicable MPE and the NOHD as the distance along the axis of the unobstructed beam from the lase...

Page 19: ...ected to an equivalent receptacle marked Hospital Grade or Hospital only To avoid the risk of electric shock do not touch any external connector and the patient simultaneously Do not use power cables...

Page 20: ...application including but not limited to the following media opacities i e cataract and heterogeneity within a particular opacity ischemic retinal changes other situations where there is no visible r...

Page 21: ...es An explosion and or fire could occur Do not use in an oxygen rich environment The treatment beam can ignite most nonmetallic materials Use fire retardant drapes and gowns The area around the treatm...

Page 22: ...slit lamp prior to use Always verify the power settings on the screen prior to pressing the footswitch Verify adjustments to laser parameters on the monitor before pressing the footswitch Verify that...

Page 23: ...olution soaked materials must be separately bagged and contained and or removed from the room prior to the use of laser e g prepping dispensers applicators drip drapes This includes items used by the...

Page 24: ...Readjust the slit lamp focus If the problem persists contact service It is the responsibility of the physician to select the appropriate power and treatment location The lowest practical setting shou...

Page 25: ...dify this equipment without authorization of the manufacturer When the laser system is interconnected with other medical electrical equipment leakage currents may be additive Ensure all systems are in...

Page 26: ...at the system is capable of emitting laser energy and that appropriate precautions should be taken such as using the appropriate eyewear when in the treatment room Door Interlock A door interlock may...

Page 27: ...y turn off To resume treatment after an electrical power loss the system must first be manually restarted by rotating the key switch to the ON position Electrical Fault Detection Circuitry If the elec...

Page 28: ...elivered to the slit lamp through a flexible fiber optic For most procedures a laser contact lens is used to direct laser energy to the part of the eye being treated The contact lens may have mirrors...

Page 29: ...omogeneously pigmented smaller area to avoid unpredictable tissue damage Exercise caution while setting treatment parameters for example exposure time and the number of spots per pattern when laser bu...

Page 30: ...s should be cautioned against any activity that could increase the venous pressure in the head neck or eyes such as straining lifting or holding their breath Patients should be advised to sleep with t...

Page 31: ...from 1 to 2 hours following laser treatment although they may occur several hours afterward For this reason it is imperative to monitor patient intraocular pressure after laser treatment for up to 24...

Page 32: ...stop button fiber ports laser fiber and electronics cable and combined 577nm 638nm lasers control electronics and power supply Laser delivery of the 638nm wavelength is for Slit Lamp only not availab...

Page 33: ...sed while system is in READY mode NOTE Footswitch marked with IPX1 is suitable for general or office use Door Interlock Plug Disables laser if treatment room doors are opened or interlock plug is remo...

Page 34: ...n to mechanical center when released There maybe a few counts from true center after released the Micro Manipulator the user can press Center button to make it center NOTE The Micro Manipulator is dis...

Page 35: ...controller 3D Controller Action 3D Controller Configurations Function Action Default Advanced Power Micromanipulator Tilt U D L R Titrate Center Pull Spots Slide U D Spacing Slide L R Orientation Rota...

Page 36: ...PASCAL Synthesis TwinStar Ophthalmic Scanning Laser Systems Page 36 of 142 88293 EN Rev C Intentionally left blank...

Page 37: ...position the laser system to make it difficult to operate the disconnection device Select an appropriate location that can accommodate the system size and allow for easy access by both the patient an...

Page 38: ...ystems Page 38 of 142 88293 EN Rev C Connecting the System Components Refer to the following diagrams for the location of system component connections on the front and rear panels of the console Front...

Page 39: ...rlock receptacle must be inserted for laser to operate F Main power cable receptacle NOTE If using an external door interlock a qualified electrical professional must install the external switch and t...

Page 40: ...creen From the Home screen 3 Turn key switch to OFF position 4 Remove key to prevent unauthorized use of system NOTE If the power cable is still connected to the electrical source some internal circui...

Page 41: ...ment press Posterior Treatment button and to go to Treatment Screen B Anterior Treatment press Anterior Treatment button and go to Treatment Screen C Select Physician press to display physicians D Sel...

Page 42: ...ems Page 42 of 142 88293 EN Rev C Posterior Treatment Screen Press Posterior Treatment button on the Home Screen to access the Posterior Treatment Screen The system will display warming up message at...

Page 43: ...eatment n 0 press to reset counter Enable in preferences C Information displays optional information and warning messages D Favorites press to open Favorites window see the section Favorites Window E...

Page 44: ...sure press up down buttons to adjust C Endpoint Mgmt press up down buttons to adjust EpM feature is available when activated D EpM press to enable disable Endpoint Management LM press to toggle Landma...

Page 45: ...n applicable NOTE Parameter controls only show on screens when applicable to the pattern selected Establish treatment parameters with Enhanced Octant when in Standby mode The Enhanced Octant pattern w...

Page 46: ...when applicable E AIM press to turn on off aiming beam in STANDBY always on in READY Aiming beam intensity scroll up down to adjust F Single Spot Pattern EpM press to display patterns available at def...

Page 47: ...en except that the only available patterns are PSLT 3 row the Array and Single Spot The Endpoint Management feature is not available Style 1 0 A Status press to select system status STANDBY or READY m...

Page 48: ...buttons to adjust C Exposure press up down buttons to adjust D Primary Pattern press to select pattern type E Treatment Plan press to toggle between 180 360 when applicable F Rotate press to rotate or...

Page 49: ...B Spot Diameter press up down buttons to adjust C Spacing Curvature press up down buttons to adjust when Applicable D Rep Rate press up down buttons to adjust when Applicable NOTE Parameter controls...

Page 50: ...panel as well as the range of values for each parameter on the treatment screen Primary Pattern Single Spot Pattern group 20ms Default 10ms Default EpM NOTE When user selects different group among Sin...

Page 51: ...Spot 50 m Off 1 0Hz to 8 0Hz 10 to 95 100 m 200 m 400 m The Single Spot pattern can be used with the slit lamp Spot diameter and repetition rate settings are adjustable NOTE The full range of settings...

Page 52: ...ariety of shapes and sizes up to a maximum of 25 spots including rectangle arrays e g 2x3 4x2 etc square arrays e g 2x2 3x3 etc vertical and horizontal lines of up to five spots Spot diameter and spac...

Page 53: ...ndmark Off All full power spots red 100 All full power spots red 100 All endpoint spots orange xx 1x2 2x1 2x2 Single column or single row arrays with at least 3 spots All full power spots red 100 Two...

Page 54: ...and 37 0 00 to 3 00 10 to 95 200 7 19 0 00 to 3 00 37 0 00 to 2 50 400 7 0 00 to 3 00 19 0 00 to 1 50 37 0 00 to 0 50 The 20 ms Hexagon pattern is selectable in three sizes and twenty four orientation...

Page 55: ...N Rev C Endpoint Management Features of Spots Endpoint Management Off or Disabled Endpoint Management On Landmark On Endpoint Management On Landmark Off All full power spots red 100 Six full power spo...

Page 56: ...f you select the pattern orientation and then select the spot diameter spacing and or curvature settings the pattern returns to its default orientation To select the pattern orientation drag your fing...

Page 57: ...Management Features Pattern Type Endpoint Management Off or Disabled Endpoint Management On Landmark On Endpoint Management On Landmark Off All full power spots red 100 Four full power spots red 100...

Page 58: ...g Laser Systems Page 58 of 142 88293 EN Rev C Single Spot Primary pattern Secondary pattern 20ms Single Spot Not available See the section Posterior Pattern Description Pattern Parameters for the deta...

Page 59: ...ng settings are also adjustable To select the Wedge pattern size press one of the quick select buttons at the bottom of the Wedge pattern screen To select the pattern orientation press one of the tick...

Page 60: ...shape and size drag your finger around the Arc pattern or press the secondary pattern button at the bottom of the Arc pattern screen to select a full circle Auto Advance Feature If the Auto Advance f...

Page 61: ...pacing Radius Inner ring 20 ms Triple Ring 200 0 50 500 m 400 0 00 500 m to 600 m 0 25 500 m to 700 m 0 50 500 m to 1000 m The Triple Ring pattern is fixed but the spot diameter spacing and radius set...

Page 62: ...ty four orientations Spot diameter and spacing settings are also adjustable To select the Line pattern size drag your finger up or down the Line pattern Dragging from top to bottom increases the numbe...

Page 63: ...abled Endpoint Management On Landmark On Endpoint Management On Landmark Off 1x2 lines All full power spots red 100 All full power spots red 100 All endpoint spots orange xx Examples Examples Examples...

Page 64: ...m 1 50 1100 m to 1200 m 2 00 1100 m 200 m 0 25 1100 m to 1200 m 0 50 1100 m The Octants pattern is selectable in three formats A B and A B as described above The pattern is selectable in subsets of o...

Page 65: ...lly advances to the next pattern The orientation is selectable in clockwise and counter clockwise on the Physician Preferences For example if octants 1 and 2 are selected the system delivers octants 1...

Page 66: ...ull power spots red 100 per octant remaining endpoint spots orange xx All endpoint spots orange xx All full power spots red 100 Zero one or Two full power spots i e only those spots that overlap with...

Page 67: ...0 m 200 m 0 00 500 m to 1800 m 900 m to 2200 m 0 25 to 0 50 500 m to 1700 m 1000 m to 2200 m 1 00 500 m to 1600 m 1100 m to 2200 m To select a number of octants drag your finger around the Octants pat...

Page 68: ...en Auto Advance Feature is Enabled System Automatically Advances to Next segment when Auto Advance Feature is Enabled The orientation is selectable in clockwise and counter clockwise on the Physician...

Page 69: ...EN Rev C Endpoint Management Features Endpoint Management Off or Disabled Endpoint Management On Landmark On Endpoint Management On Landmark Off All full power spots red 100 Four full power spots red...

Page 70: ...formation on the Enhanced Octants pattern Auto Transition Feature In 15ms EpM Enhanced Octant pattern if Array or Hexagon pattern is selected in Auto Transition after Enhanced Octants at Physician Pre...

Page 71: ...r completing the whole EpM enhanced octants pattern The LM can be enabled if needed When auto advanced mode is not enabled there is no auto transit to configured array or hexagon pattern after complet...

Page 72: ...v C Endpoint Management Features Endpoint Management On Landmark On Endpoint Management On Landmark Off Four full power spots red 100 per octant remaining endpoint spots orange xx All endpoint spots o...

Page 73: ...pattern Endpoint Management Features Pattern Type Endpoint Management On Landmark On Endpoint Management On Landmark Off 1x2 All full power spots red 100 All endpoint spots orange xx 2x1 2x2 Single co...

Page 74: ...hthalmic Scanning Laser Systems Page 74 of 142 88293 EN Rev C NOTE The EpM is always ON for all patterns in EpM group It cannot be disabled The Landmark is always off for Array s 2 2 sub pattern in Ep...

Page 75: ...ttern Description Pattern Parameters for the detailed information on the Hexagon pattern Endpoint Management Features of Spots Endpoint Management On Landmark On Endpoint Management On Landmark Off Si...

Page 76: ...100 m 10 to 95 200 m The Single Spot pattern can be used with the slit lamp Spot diameter and repetition rate settings are adjustable NOTE The Power and Exposure settings cannot be adjusted for 15ms E...

Page 77: ...wo anterior pattern types The Single Spot patterns and the Array 20msdefault are available in the Anterior Treatment screen Single Spot Array Primary Pattern See the section Posterior Pattern descript...

Page 78: ...ctable in a variety of shapes and sizes up to a maximum of 9 spots including square arrays rectangle arrays vertical and horizontal lines of up to 3 spots and a single spot Spot diameter and spacing s...

Page 79: ...election of desired laser dosimetry Power within the titration pattern decreases from left to right starting with the full power setting and decreasing by one power increment for each spot moving to t...

Page 80: ...PASCAL Synthesis TwinStar Ophthalmic Scanning Laser Systems Page 80 of 142 88293 EN Rev C NOTE The pattern selection bar is disabled when Titration is ON...

Page 81: ...els where ophthalmoscopically visible lesions are not achieved while referencing a dosage with a visible effect the 100 dosage The EpM features are only enabled on retinal treatment patterns for use i...

Page 82: ...TwinStar Ophthalmic Scanning Laser Systems Page 82 of 142 88293 EN Rev C application is moved across the retina the user can adjust the laser power to maintain the same lesion appearance as the origin...

Page 83: ...nable Treatment Time select to display treatment time and date on Treatment screen and report D Surgical Timeout Enable Disable screen to review patient information prior advancing to Treatment Screen...

Page 84: ...eport format B Time Format press to select time format C Date Format press to select date format D Additional Features Enter activations codes for optional upgrades E Home press to go to Home screen F...

Page 85: ...t button on the Home screen Patient Information Window To enter the patient information 1 Press the First Name field enter the information using the on screen keyboard and then press OK 2 Press the La...

Page 86: ...ts have reached at the top of the FOV the blinking aiming spots stay at the same position of the titration pattern spots The location of titration is set to the initial position of the titration when...

Page 87: ...Ocular Setting Reminder displays settings to remind to set ocular power before treatment B Advance Direction select direction to advance the pattern C 3D Controller Mode set to Advanced or Default co...

Page 88: ...Scanning Laser Systems Page 88 of 142 88293 EN Rev C Contact Lens Selection Screen A Add press to enter custom lens Delete press to delete lens B Home press to go to Home screen C Reset discard chang...

Page 89: ...ay favorite details information pattern power exposure spot diameter spacing lens when the favorite entry is pressed and held for 1 second in the favorite list Click the popup or other place to close...

Page 90: ...r Ophthalmic Scanning Laser Systems Page 90 of 142 88293 EN Rev C Once a favorite is loaded the favorite name will be displayed in status area NOTE If any parameter is changed the favorite name in sta...

Page 91: ...the Rename Remove Save and Move buttons are enabled A Done press to finish the Edit of Favorite Window B Rename press to change the name of the selected favorite C Remove press to remove the selected...

Page 92: ...Move button to start the move operation Notice the Move button is change to Cancel Move which can be used to cancel the move operation Select the favorite whose position you want to move the previousl...

Page 93: ...ent session A Page press to show the previous page and to show the next page when applicable B Zoom press to zoom out and to zoom in the preview C Export Press to export the treatment report to the co...

Page 94: ...l the reports exported from Synthesis will be stored in the synthesis_report folder in the USB drive The user can plug in the USB drive to a PC to copy or delete the exported reports The USB drive sho...

Page 95: ...y added drive Here is the example to format a new USB Drive letter E is just an example in the picture below it could be different on a different PC Right click the newly added USB drive select Format...

Page 96: ...ent Report if desired Reports can be enabled or disabled from the System Setup screen Three report templates are available Posterior Basic Info Treatment Report Posterior Advanced Info Treatment Repor...

Page 97: ...PASCAL Synthesis TwinStar Ophthalmic Scanning Laser Systems Page 97 of 142 88293 EN Rev C Sample Posterior Info Treatment Report...

Page 98: ...PASCAL Synthesis TwinStar Ophthalmic Scanning Laser Systems Page 98 of 142 88293 EN Rev C Sample Posterior Advanced Info Treatment Report...

Page 99: ...asic Info Treatment Report NOTE The graphical depiction of the area treated on the Anterior Laser Treatment Report represents the physical area of the TM that was treated during the procedure If any a...

Page 100: ...of the laser beam with the slit lamp joystick 9 Press Titrate to switch to a single spot and perform test burns at the periphery of the treatment area 10 Adjust the laser treatment power for therapeu...

Page 101: ...PASCAL Synthesis TwinStar Ophthalmic Scanning Laser Systems Page 101 of 142 88293 EN Rev C Intentionally left blank...

Page 102: ...ion pressing End Treatment returns the system to the Home screen whether or not the treatment report feature is enabled 2 Disinfect the chin rest and head rest using mild soap and water Dry with a sof...

Page 103: ...er system performance User Maintenance The following maintenance procedures are to be performed by the user to ensure proper performance of the system Cleaning the Console External Surfaces Clean the...

Page 104: ...rom the wall outlet and the system main power receptacle 3 Insert a small insulated flathead screwdriver into the fuse holder release receptacle and unlock and remove the fuse holder 4 Replace the blo...

Page 105: ...ower output mW 577 nm 0 2000 638 nm 0 600 Duty cycle 100 Pulse durations ms 10 1000 Pulse interval 1 1 5 2 3 4 5 6 7 and 8 Hz single spot Pulse counter 0 99 999 Laser beam diameter 577 nm 50 100 200 4...

Page 106: ...h air or with oxygen or nitrous oxide Continuous operation Classifications Approvals EN IEC 60601 2 22 Laser Safety Requirements for Diagnostic and Therapeutic Laser Equipment EN IEC 60601 1 Internati...

Page 107: ...mercial shipping altitude Non operating temperature 10 to 55 C 14 to 131 F Maximum humidity 85 non condensing Atmospheric pressure range 70 0 106 0 kPa Physical Characteristics Console height 9 in 23...

Page 108: ...sult the Service Manual for additional troubleshooting options 1 Verify that the wall circuit breaker is in the ON position 2 Verify that the power cable is correctly attached to the system and the wa...

Page 109: ...F position Suggestion Insert key and rotate to ON position Probable Cause Internal system error Suggestion Turn key switch to OFF position wait at least one minute and then turn to ON position If syst...

Page 110: ...ble Cause Loose connection or disconnected from system Suggestion Ensure that cables are correctly connected Reboot the system Attempt to use 3D Controller when in Standby mode and confirm parameters...

Page 111: ...not connected Suggestion Connect footswitch Probable Cause Aiming beam is on low intensity setting Suggestion Adjust aiming beam intensity on control panel Probable Cause After five minutes of non us...

Page 112: ...Stop 03 Footswitch Connect X Footswitch has malfunctioned or been disconnected Connect Footswitch 04 Power Rails X An error was detected with the power supplies Reboot Call service if error persists...

Page 113: ...ectric current was drawn by the Red 60 m Laser module when it was not expected Verify device connections 23 Treatment Current Under for Red 200 m Low X Red 200 m Laser module draws electric current be...

Page 114: ...Laser module treatment temperature is severely low Check fan and ventilation Allow system to warm up 34 BRF Treatment Temperature High Moderate X Laser module treatment temperature is high Check fan...

Page 115: ...lation Allow system to warm up 46 Ambient Temperature High Moderate X The ambient temperature is high Allow system to cool Reconfigure treatment parameters if necessary 47 Ambient Temperature High Sev...

Page 116: ...ce 58 OPSL Treatment Local Light Over Low X Laser output is 20 over the expected value User to select End Treatment and Return to the Home Screen Re access treatment screen and reconfigure treatment p...

Page 117: ...ue User to select End Treatment and Return to the Home Screen Re access treatment screen and reconfigure treatment parameters If error repeats End Treatment and call Service 65 Red 200 m Treatment Loc...

Page 118: ...e Call service if error persists 73 Y Galvo Spot Position Service Error During Aiming X An error occurred within the spot position service regarding the Y galvo during aiming beam output Clear error t...

Page 119: ...re failed to enable or disable the audio Call service if error persists 204 Touchscreen Error X The Touchscreen was disconnected Reboot Check connections Call service if error persists 205 Kill Line A...

Page 120: ...ce if error persists 222 Invalid Attachment Calibration X The calibration file is missing not readable or incomplete Check the log file for the exact problem Reboot Call service if error persists 223...

Page 121: ...PASCAL Synthesis TwinStar Ophthalmic Scanning Laser Systems Page 121 of 142 88293 EN Rev C...

Page 122: ...em for calibration In fact calibration should be done with the covers on Tools Required USB keyboard and mouse NIST traceable Gentec calibrated optical power meter Power meter to chinrest adapter 1 De...

Page 123: ...nt Adequate space around the console ensures proper air circulation for system cooling purposes 6 If there are changes in environmental conditions temperature or humidity allow system to acclimate for...

Page 124: ...EM disturbances is high Patient Environment The Patient Environment is defined by the following When the patient or inspector comes in contact with the devices including the connecting devices When th...

Page 125: ...EN Rev C CAUTION Do not use the power strip in the patient environment Do not connect an additional power strip or an extension cord to the system Do not connect any device which is not recognized as...

Page 126: ...ry the EQUIPMENT or SYSTEM should be observed to verify normal operation in the configuration in which it will be used d The use of the ACCESSORY transducer or cable with EQUIPMENT and SYSTEMS other t...

Page 127: ...its are designed to provide reasonable protection against harmful interference in a residential installation This equipment generates uses and can radiate radio frequency energy and if not installed a...

Page 128: ...omagnetic environment guidance RF emissions CISPR 11 Group 1 The PASCAL Synthesis Ophthalmic Scanning Laser System uses RF energy only for its internal function Therefore its RF emissions are very low...

Page 129: ...1 kV line s to line s 2 kV line s to earth 1 kV line s to line s 2 kV line s to earth Main power quality should be that of a typical commercial or hospital environment Voltage dips short interruption...

Page 130: ...dio communication equipment a 3 Vrms 150kHz to 80MHz 10 V m 80MHz to 2 7GHz Proximity electromagnetic field from radio communication equipment a Portable and mobile RF communications equipment should...

Page 131: ...n 18Hz 1 8 0 3 27 450 430 470 GMRS 460 FRS 460 FM 5kHz 1kHz sine 2 0 3 28 710 704 787 LTE Band 13 17 Pulse modulation 217Hz 0 2 0 3 9 745 780 810 800 960 GSM 800 900 TETRA 800 iDEN820 CDMA850 LTE Band...

Page 132: ...halmic Lasers Third Edition Photocoagulation of Ocular Disease Application and Technique 1988 8 Kurata F et al Intraocular pressure the day of Krypton Laser Trabeculoplasty in Primary Open angle Glauc...

Page 133: ...ions Fix the face to the chinrest forehead rest Keep the eye open Understand and follow instructions when undergoing a treatment Intended User Profile This device must be used by a physician only Acce...

Page 134: ...ved during the applicable warranty period by Iridex Corporation If it becomes necessary to return a product for repair and or adjustments authorization from Iridex Corporation must be obtained Instruc...

Page 135: ...taminated a signed Decontamination Certificate provided in this section must be enclosed in the package If equipment is received without a Decontamination Certificate Iridex Corporation will assume th...

Page 136: ...stitution City State Province Country Has undergone decontamination with a commercially available germicide cleared for use as a Hospital Disinfectant and is clean and free from biohazards including b...

Page 137: ...tive This symbol is applicable for EU members states only Battery users must not dispose of batteries as unsorted general waste but treat properly If a chemical symbol is printed beneath the symbol sh...

Page 138: ...lar meshwork without overlap or excessive gaps When the PSLT pattern is selected the pattern is delivered when you depress the footswitch after which the system automatically rotates the pattern clock...

Page 139: ...view and not in the periphery Use contact lens to set location If during the course of the treatment the footswitch is released before the entire pattern is delivered Treatment Complete and NN Incomp...

Page 140: ...The PSLT 3 row Array 20ms default and Single Spot patterns are available in the Anterior Treatment screen PSLT 3 Row Array Single Spot Primary Pattern See the section Posterior Pattern description Pa...

Page 141: ...lectable in a variety of shapes and sizes up to a maximum of 9 spots including square arrays rectangle arrays vertical and horizontal lines of up to 3 spots and a single spot Spot diameter and spacing...

Page 142: ...T 3 Row Primary pattern Secondary pattern PSLT 3 Row Not available General Use Trabeculoplasty The PSLT 3 Row pattern is selectable in various orientations To select the pattern orientation press Rota...

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