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Iridex PASCAL Synthesis Operator'S Manual Download Page 130

 

 

PASCAL

® 

Synthesis Ophthalmic Scanning Laser Systems 

Page 130 of 141 

88292-EN, Rev D 

a 

The  table  below  shows  the  proximity  electromagnetic  field  from  radio  communication 
equipment. 

Test 

frequency 

[MHz] 

Band 

[MHz] 

Equipment 

Modulation 

Maximum 
output[W] 

Distance 

[m] 

Immunity 

test value 

[V/m] 

385 

380-

390 

TETRA 400 

Pulse 

modulation 

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 5 

Pulse 

modulation 

18Hz 

2 

0.3 

28 

870 

930 

1720 

1700-

1990 

GSM 1800 

CDMA 1900 

GSM 1900 

DECT 

LTE Band 1,3,4,25 

UMTS 

Pulse 

modulation 

217Hz 

2 

0.3 

28 

1845 

1970 

2450 

2400-

2570 

Bluetooth 

WLAN 802.11 b/g/n 

RFID 2450 

LTE Band7 

Pulse 

modulation 

217Hz 

2 

0.3 

28 

5240 

5100-

5800 

WLAN 802.11 a/n 

Pulse 

modulation 

217Hz 

0.2 

0.3 

9 

5500 
5785 

 

 

 

Summary of Contents for PASCAL Synthesis

Page 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...

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

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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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