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PASCAL

® 

Synthesis Ophthalmic Scanning Laser Systems 

Page 25 of 141 

88292-EN, Rev D 

Vibration or physical shock may affect the quality, performance and reliability of the 
equipment. 

 

Regulatory Compliance Safety Features 

PASCAL Synthesis Ophthalmic Scanning Laser System complies with 21 CFR subchapter J 
as administrated by the Center for Devices and Radiological Health of the Food and Drug 
Administration (FDA). The following FDA compliance safety features are included: 

 

Key Lock Switch 

The system can be activated only with the proper key to operate the master key switch. The 
key cannot be removed in the ON position and the system will operate only with the key in 
place. When treatments are complete, always remove and secure the key to prevent 
unauthorized use of the system. 

 

Laser Emission Indicator 

The laser emission indicator is displayed to warn the user that 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 be used in conjunction with a remote switch to disable the system in 
case of certain external events (e.g., the opening of a treatment room door). A remote 
switch or interlock can be wired to the door interlock plug and connected to the system 
interlock receptacle on the rear of the system console. If a remote switch is used, the system 
can be set in the READY mode only when the remote switch is closed. Breaking the 
connection by opening the switch (door) or removing the plug disables the system and the 
system returns to STANDBY mode with “<Door Interlock>” displayed on the control panel. 

 

Emergency Stop 

When pressed, immediately turns off power to the laser. 

 

Protective Housing 

The system console has a protective housing that prevents unintended human access to 
laser radiation above Class I limits. This housing is to be opened only by certified personnel. 
 

Safety Interlocks 

The protective housing is not designed to be removed by the user during operation or 
maintenance. Therefore, the system does not have and is not required to have any safety 
interlock within the meaning of US FDA 21 CFR, Section 1040 or European EN 60825-1. 

 

Safety Shutter 

Содержание PASCAL Synthesis

Страница 1: ...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 iridexr...

Страница 2: ...PASCAL Synthesis Ophthalmic Scanning Laser Systems Page 2 of 141 88292 EN Rev D Intentionally left blank...

Страница 3: ...opying 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 tab...

Страница 4: ...PASCAL Synthesis Ophthalmic Scanning Laser Systems Page 4 of 141 88292 EN Rev D Intentionally left blank...

Страница 5: ...or diagnosis and treatment of ocular pathology in both the posterior and anterior segments Intended for use in the posterior segment to perform retinal photocoagulation panretinal photocoagulation foc...

Страница 6: ...ance 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 General Safety an...

Страница 7: ...Additional Safety Considerations 24 Regulatory Compliance Safety Features 25 Key Lock Switch 25 Laser Emission Indicator 25 Door Interlock 25 Emergency Stop 25 Protective Housing 25 Safety Interlocks...

Страница 8: ...int Management with Landmark Patterns optional 81 System Software Setup 83 System Setup Screen 83 Patient Information Feature 85 Progressive Titrate 87 Physician Preferences Window 87 Edit Physician P...

Страница 9: ...t Environment 123 Electromagnetic Compatibility 125 Ophthalmology References 131 General information on Usage 132 Intended Patient Population 132 Intended User Profile 132 Accessories 132 Warranty Inf...

Страница 10: ...PASCAL Synthesis Ophthalmic Scanning Laser Systems Page 10 of 141 88292 EN Rev D CAUTIONS WARNINGS...

Страница 11: ...ance 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 Mainten...

Страница 12: ...nthesis 532 nm Laser Radiation Caution Label includes Laser Emission Warning PASCAL Synthesis System Information Label includes Manufacturer Part Number Serial Number Manufacture Date Follow operating...

Страница 13: ...4 Laser Emission Laser beam may be present in this area when opened Danger label includes Laser Emission Warning Wavelength Power Laser Class PASCAL Synthesis 532 nm Pascal Synthesis 577 nm USB Conne...

Страница 14: ...ge 14 of 141 88292 EN Rev D Laser Aperture Label Laser Emission Warning Warning Hot Surface Label Warning this surface may be extremely hot General Warning Label Additional Labels Footswitch Ingress P...

Страница 15: ...nformation Iridex Corporation laser systems are precision medical instruments The systems have undergone extensive testing With proper handling they are useful and reliable clinical instruments To pro...

Страница 16: ...e damage Do not use eyewear that is broken or damaged The laser emission indicator is displayed on the Treatment screen to warn the user that the system is capable of emitting laser energy Appropriate...

Страница 17: ...area ANSI Standard Z136 1 2007 defines MPE as the level of radiation to which a person may be exposed without hazardous effect or adverse biological changes in the eye or skin the NHZ as the space wit...

Страница 18: ...l before they enter the controlled area 3 The treatment room door should be kept closed during treatment Electrical Hazards WARNING DANGEROUS VOLTAGE To avoid the risk of electric shock this equipment...

Страница 19: ...t of the affected areas The larger the pattern the more likely that spots within the pattern would be non uniformly delivered Smaller pattern sizes may be less likely to produce non homogeneous lesion...

Страница 20: ...ammables or explosives such as volatile anesthetics alcohol certain surgical preparation solutions or other such substances An explosion and or fire could occur Do not use in an oxygen rich environmen...

Страница 21: ...Please be aware that with longer completion times the possibility of patient movement increases the risk of treatment of unintended targets Verify eye safety filter is properly attached to the slit l...

Страница 22: ...reating physician must visualize treatment through the slit lamp at all times Footswitch marked with IPx1 is suitable for general or office use Do not use the system with footswitch in the operating r...

Страница 23: ...slit lamp is the expected size If the aiming beam size or pattern appears inappropriate or distorted do not proceed with treatment Readjust the slit lamp focus If the problem persists contact service...

Страница 24: ...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 install...

Страница 25: ...en in the treatment room Door Interlock A door interlock may be used in conjunction with a remote switch to disable the system in case of certain external events e g the opening of a treatment room do...

Страница 26: ...n of Regulatory and Other System Labels As required by the regulatory bodies appropriate warning labels have been mounted in specified locations on the instrument to indicate conditions under which th...

Страница 27: ...e treated The contact lens also helps to hold the eye open and still so that laser energy can be delivered effectively Systems may be used for procedures performed in a hospital or in a physician s of...

Страница 28: ...neously 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 burns a...

Страница 29: ...neck or eyes such as straining lifting or holding their breath Patients should be advised to sleep with the head of their bed elevated 15 to 20 degrees Patients should be cautioned against stifling a...

Страница 30: ...this reason it is imperative to monitor patient intraocular pressure after laser treatment for up to 24 hours Peripheral anterior synechiae may occur when the posterior portion of the trabecular mesh...

Страница 31: ...sole Houses the key switch emergency laser stop button fiber ports laser fiber and electronics cable 532 nm or 577 nm single wavelength laser control electronics and power supply Touchscreen LCD Contr...

Страница 32: ...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 removed...

Страница 33: ...o mechanical center when released There maybe a few counts from true center after released the Micro Manipulator the user can press Home button to make it center NOTE The Micro Manipulator is disabled...

Страница 34: ...roller 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 Rotate C...

Страница 35: ...er Systems Page 35 of 141 88292 EN Rev D LIO Laser Indirect Ophthalmoscope optional accessory The LIO is an optional accessory to the PASCAL systems Refer to the LIO operator manual for detailed safet...

Страница 36: ...r 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 and the physician En...

Страница 37: ...8292 EN Rev D 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 A B C Front Panel Connection...

Страница 38: ...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 the to...

Страница 39: ...een From the Home screen 6 Turn key switch to OFF position 7 Remove key to prevent unauthorized use of system NOTE If the power cable is still connected to the electrical source some internal circuits...

Страница 40: ...t press Posterior Treatment button and go to Treatment Screen B Anterior Treatment press Anterior Treatment button and go to Treatment Screen C Select Physician press to display physicians D Select Fa...

Страница 41: ...age 41 of 141 88292 EN Rev D 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 the c...

Страница 42: ...ent 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 LENS...

Страница 43: ...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 Landmark pa...

Страница 44: ...plicable 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 will...

Страница 45: ...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 default...

Страница 46: ...that the only available patterns are the PSLT 3 row Array and Single Spot patterns The Endpoint Management feature is not available Style 1 0 A Status press to select system status STANDBY or READY m...

Страница 47: ...ns 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 adva...

Страница 48: ...ot 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 only...

Страница 49: ...nel as well as the range of values for each parameter on the treatment screen Primary Pattern Single Spot Pattern 20ms Default 10ms Default EpM NOTE When user selects different group among Single Spot...

Страница 50: ...ingle Spot pattern can be used with the slit lamp or an optional laser indirect ophthalmoscope LIO Spot diameter and repetition rate settings are adjustable NOTE The full range of settings is not avai...

Страница 51: ...iety 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 spacin...

Страница 52: ...k 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 full...

Страница 53: ...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 orientations Spot diameter and spacing settings a...

Страница 54: ...D 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 spots re...

Страница 55: ...u 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 finger a...

Страница 56: ...gement 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 remai...

Страница 57: ...ser Systems Page 57 of 141 88292 EN Rev D Single Spot Primary pattern Secondary pattern 20ms Single Spot Not available See the section Posterior Pattern Description Pattern Parameters for the detailed...

Страница 58: ...ettings 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 tickmark...

Страница 59: ...pe 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 featu...

Страница 60: ...ng 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 setting...

Страница 61: ...ur 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 number of...

Страница 62: ...d 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 Oth...

Страница 63: ...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 one to...

Страница 64: ...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 and...

Страница 65: ...ower 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 forma...

Страница 66: ...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 pattern NOTE The selection of inner radius and oute...

Страница 67: ...uto 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 Pref...

Страница 68: ...Rev D 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 100...

Страница 69: ...tion 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 Preferen...

Страница 70: ...pleting 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 completing o...

Страница 71: ...ndpoint 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 orange...

Страница 72: ...ern 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 column...

Страница 73: ...mic Scanning Laser Systems Page 73 of 141 88292 EN Rev D 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 EpM gro...

Страница 74: ...n 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 Six fu...

Страница 75: ...M Single Spot 100 m 10 to 95 200 m The Single Spot pattern can be used with the slit lamp or an optional laser indirect ophthalmoscope LIO Spot diameter and repetition rate settings are adjustable NOT...

Страница 76: ...esis Ophthalmic Scanning Laser Systems Page 76 of 141 88292 EN Rev D NOTE The Endpoint Management feature is not available with the LIO The Endpoint Management feature is only available for EpM ON and...

Страница 77: ...anterior pattern types The Single Spot patterns and Array 20ms default are available in the Anterior Treatment screen Single Spot Array Primary Pattern See the section Posterior Pattern description Pa...

Страница 78: ...e 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 settin...

Страница 79: ...linear pattern to facilitate selection 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 incr...

Страница 80: ...Synthesis Ophthalmic Scanning Laser Systems Page 80 of 141 88292 EN Rev D Refer to Warning Section for Pattern Titration Warning Information NOTE The pattern selection bar is disabled when Titration...

Страница 81: ...hthalmoscopically 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 in retinal ph...

Страница 82: ...L Synthesis Ophthalmic Scanning Laser Systems Page 82 of 141 88292 EN Rev D moved across the retina the user can adjust the laser power to maintain the same lesion appearance as the original titration...

Страница 83: ...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 E Ph...

Страница 84: ...ormat 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 press...

Страница 85: ...ton 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 Last Na...

Страница 86: ...PASCAL Synthesis Ophthalmic Scanning Laser Systems Page 86 of 141 88292 EN Rev D...

Страница 87: ...ve 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 you p...

Страница 88: ...D A 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 Defaul...

Страница 89: ...ning Laser Systems Page 89 of 141 88292 EN Rev D 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 changes D...

Страница 90: ...vorite 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 the p...

Страница 91: ...thalmic Scanning Laser Systems Page 91 of 141 88292 EN Rev D Once a favorite is loaded the favorite name will be displayed in status area NOTE If any parameter is changed the favorite name in status a...

Страница 92: ...Rename Remove Save and Move buttons are enabled A B C D E F 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 s...

Страница 93: ...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 previously se...

Страница 94: ...e completion of each patient treatment 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 ex...

Страница 95: ...PASCAL Synthesis Ophthalmic Scanning Laser Systems Page 95 of 141 88292 EN Rev D The Export is disabled if no USB drive is plugged into the console s USB port...

Страница 96: ...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 should b...

Страница 97: ...ded 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 fro...

Страница 98: ...eport 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 Report Ant...

Страница 99: ...PASCAL Synthesis Ophthalmic Scanning Laser Systems Page 99 of 141 88292 EN Rev D Sample Posterior Info Treatment Report...

Страница 100: ...PASCAL Synthesis Ophthalmic Scanning Laser Systems Page 100 of 141 88292 EN Rev D Sample Posterior Advanced Info Treatment Report...

Страница 101: ...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 areas...

Страница 102: ...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 therapeutic...

Страница 103: ...ure time 5 Select the appropriate laser power 6 Make any necessary adjustments to the headset to ensure safe and clear view of the retina as described in the LIO operator manual 7 Position the aspheri...

Страница 104: ...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 soft cl...

Страница 105: ...ystem 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 exte...

Страница 106: ...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 blown f...

Страница 107: ...emiconductor Laser OPSL Wavelength nm 532 577 Power output mW 0 2000 Duty cycle 100 Pulse durations ms 10 1000 Pulse interval 1 1 5 2 3 4 5 6 7 and 8 Hz single spot or LIO Pulse counter 0 99 999 Laser...

Страница 108: ...esthetic 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 I...

Страница 109: ...Maximum humidity 85 non condensing Atmospheric pressure range 70 0 106 0 kPa Physical Characteristics PASCAL Synthesis 532 nm PASCAL Synthesis 577 nm Console height 9 in 23 cm Console width 15 in 38 c...

Страница 110: ...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 wall ou...

Страница 111: ...sition 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 system f...

Страница 112: ...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 can...

Страница 113: ...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 use sys...

Страница 114: ...g too long in the ISR or is in an infinite loop Reboot Call service if error persists 06 Watchdog Main X The watchdog fired this implies the back end is taking too long in the ISR or is in an infinite...

Страница 115: ...atment Temperature Low Moderate X Laser module treatment temperature is low Check fan and ventilation Allow system to warm up 41 Red Treatment Temperature Low Severe X Laser module treatment temperatu...

Страница 116: ...econfigure treatment parameters If error repeats End Treatment and call Service 57 OPSL Treatment Local Light Under Low X Laser output is 20 under the expected value User to select End Treatment and R...

Страница 117: ...er High X 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 Tr...

Страница 118: ...r error to continue Call service if error persists 76 Spot Size Service F Galvo X An error occurred within the spot size service regarding the F galvo Clear error to continue Call service if error per...

Страница 119: ...nt LIO or SLA says that the device does not support the system laser s color Check LIO or SLA connection Reboot Call service if error persists 214 Bad Attachment Version X The 1 wire data on an attach...

Страница 120: ...n to the Home Screen Re access treatment screen and reconfigure treatment parameters If error repeats End Treatment and call Service 225 Cannot Save Favorite X Error occurs while saving favorite infor...

Страница 121: ...r 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 ener...

Страница 122: ...dequate 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 4 h...

Страница 123: ...agnetic resonance imaging where the intensity of EM disturbances is high Patient Environment The Patient Environment is defined by the following When the patient or inspector comes in contact with the...

Страница 124: ...ent Insulation transformer 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...

Страница 125: ...o 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 than those specified may result in increased EMI...

Страница 126: ...re 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 and us...

Страница 127: ...etic 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 and...

Страница 128: ...V 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 interruptions an...

Страница 129: ...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 be u...

Страница 130: ...Hz 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 5 P...

Страница 131: ...ves in Ophthalmology Vol 4 No 4 June 1980 5 Schwartz AL et al Al Krypton Laser Trabecular Surgery in Uncontrolled Phakic Open Angle Glaucoma Ophthalmology Vol 88 No 3 March 1981 6 Ophthalmic Laser The...

Страница 132: ...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 Accessor...

Страница 133: ...g 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 Instructions as...

Страница 134: ...nated 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 the pr...

Страница 135: ...itution 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 but...

Страница 136: ...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 shown...

Страница 137: ...ork 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 clockwise If t...

Страница 138: ...d 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 Incomplete Seg...

Страница 139: ...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 Parameters...

Страница 140: ...able 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 set...

Страница 141: ...ow 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 Rotate bu...

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