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PASCAL

Synthesis TwinStar Ophthalmic Scanning Laser Systems

Page 106 of 142

88293-EN, Rev C

Electrical Requirements

Voltage

100-240V~, 50/60Hz

Rated power

200VA

Fusing

200VA T2AH 250V

Fan noise

< 55 dBA

Product Classifications per IEC 60601-1

Class I equipment
Type B equipment
Standard equipment, Footswitch is IPX1
Non-sterile product
Equipment not suitable for use in the presence of a flammable anesthetic mixture with
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

International Safety Requirements for Medical Electrical
Equipment

EN/IEC 60601-1-2

EMC Requirements for Medical Electrical Equipment

ISO 14971

Risk Management for Medical Devices

CAN/CSA-C22.2 No.
60601-1

Canadian deviations for Medical Electrical Equipment

ANSI/AAMI ES 60601-1 US Safety Requirements for Medical Electrical Equipment

EN/IEC 60825-1

Safety of laser products

FCC

Tested and Complies With FCC Part 15 Class B

Содержание PASCAL Synthesis TwinStar

Страница 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...

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

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 9: ...PASCAL Synthesis TwinStar Ophthalmic Scanning Laser Systems Page 9 of 142 88293 EN Rev C Intentionally left blank...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

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

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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