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Iridex PASCAL Synthesis Operator's Manual

Ophthalmic scanning laser system
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(SL-PA04 single 532 nm / 577 nm)
Ophthalmic Scanning Laser System
European Authorized Representative
Obelis
Boulevard Général Wahis 53
1030 Brussels
Belgium
Phone: +32.2.732.59.54
Fax: +32.2.732.60.03
www.obelis.net
PASCAL Synthesis System Software 3.6.1
Caution: "Federal law restricts this device to sale by or on the order of a physician"
PASCAL
®
Operator Manual
Synthesis™
Iridex Corporation
1212 Terra Bella Avenue
Mountain View, CA 94043
USA
Office: +1.650.940.4700
Fax: +1.650.962.0486
www.iridexretina.com

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  • Page 1 Boulevard Général Wahis 53 Mountain View, CA 94043 1030 Brussels Belgium Office: +1.650.940.4700 Phone: +32.2.732.59.54 Fax: +1.650.962.0486 Fax: +32.2.732.60.03 www.iridexretina.com www.obelis.net PASCAL Synthesis System Software 3.6.1 Caution: “Federal law restricts this device to sale by or on the order of a physician”...
  • Page 2 Intentionally left blank ® PASCAL Synthesis Ophthalmic Scanning Laser Systems Page 2 of 141 88292-EN, Rev D...
  • Page 3 Iridex Corporation. PASCAL Synthesis; PASCAL Synthesis Ophthalmic Scanning Laser System are trademarks of Iridex Corporation. PASCAL Synthesis refers to a family of laser products: single wavelength 532 nm and single wavelength 577 nm. ® PASCAL...
  • Page 4 Intentionally left blank ® PASCAL Synthesis Ophthalmic Scanning Laser Systems Page 4 of 141 88292-EN, Rev D...

  • Page 5: Introduction

    INTRODUCTION INTENDED USE / INDICATIONS FOR USE PASCAL ® Synthesis Ophthalmic Scanning Laser System is a laser system console with an integrated slit lamp. The system connects to the slit lamp to enable laser energy to be delivered through the slit lamp illumination path. The system may be used for standard single shot photocoagulation and laser scanning patterns.
  • Page 6 FEATURES PASCAL Synthesis Ophthalmic Scanning Laser System is a laser system console with an integrated slit lamp. The system connects to the slit lamp to enable laser energy to be delivered through the slit lamp illumination path. The system may be used for standard single shot photocoagulation and laser scanning patterns.

  • Page 7: Table Of Contents

    Table of Contents INTRODUCTION ..........................5 INTENDED USE / INDICATIONS FOR USE ..................5 Table of Contents ............................ 7 CAUTIONS & WARNINGS ........................ 10 Disclaimer .............................. 11 Console Labels ..........................11 Additional Labels ..........................14 Operator Manual Symbol Definitions ..................... 15 General Safety and Regulatory Information ..................
  • Page 8 3D Controller Action ........................34 LIO (Laser Indirect Ophthalmoscope) – optional accessory ............35 System Installation and Setup ....................... 36 Connecting the System Components .................... 37 System Start-up and Shut-down ......................39 Starting the System ........................39 Shutting Down the System (Standard Shut-down) ................ 39 Emergency Shut-down ........................
  • Page 9 System does not turn on......................111 Error Messages ..........................114 Calibration Procedure .......................... 121 Disclaimer Warning ........................121 Calibration Instructions ........................ 121 System Relocation Instructions ......................122 Room Preparation ..........................122 Instructions for Use ..........................123 Intended Use Environment ......................123 Patient Environment ........................

  • Page 10: Cautions & Warnings

    CAUTIONS & WARNINGS ® PASCAL Synthesis Ophthalmic Scanning Laser Systems Page 10 of 141 88292-EN, Rev D...

  • Page 11: Disclaimer

    Disclaimer Calibration of the PASCAL Synthesis Ophthalmic Scanning Laser System is a service procedure to be performed only by Iridex Corporation-certified personnel or customers who have taken and passed a Iridex Corporation Bio-Medical Preventative Maintenance 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 Maintenance Training course voids any existing manufacturer’s warranty on...
  • Page 12 Laser Radiation Caution Label, includes: Laser Emission Warning PASCAL Synthesis (577nm) PASCAL Synthesis (532 nm) System Information Label, includes: Manufacturer Part Number Serial Number Manufacture Date Follow operating instructions WEEE Directive Type B applied part λ Wavelength (nm) Rx ONLY...
  • Page 13 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 Connections Wireless USB Caution Remote Door Interlock Connection Footswitch Connection ®...

  • Page 14: Additional Labels

    Laser Aperture Label Laser Emission Warning Warning, Hot Surface Label Warning, this surface may be extremely hot. General Warning Label Additional Labels Footswitch Ingress Protection “Hospital Grade” Cord Grounding Instructions ® PASCAL Synthesis Ophthalmic Scanning Laser Systems Page 14 of 141 88292-EN, Rev D...

  • Page 15: Operator Manual Symbol Definitions

    Iridex Corporation lasers are classified as Class IV lasers by the National Center for Devices and Radiological Health. Class IV represents the highest power lasers; for this reason, the user must take precautions to prevent exposure of laser energy to the eye and skin from either direct or diffusely reflected laser beams, except as a therapeutic application.

  • Page 16: Ocular Protection

    Z136.3-2005―American National Standard for the Safe Use of Lasers in Health Care Facilities, ANSI Z136.1-2000―American National Standard for the Safe Use of Lasers, CAN/CSA-S386-2008―Laser Safety in Health Care Facilities and other national standards as may be applicable for the country in which the laser system is used. This device complies with Part 15 of the FCC Rules.

  • Page 17: Laser Safety Eyewear

    power varying from barely visible to 1 mW maximum. The safe (Class II) exposure duration limit at a maximum power level of 1 mW is 3.9 seconds. To protect the patient from possible retinal damage during treatment, use the lowest practical aiming beam intensity and the minimal required time duration.

  • Page 18: Electrical Hazards

    The area around the laser and footswitch shall be kept dry. Do not operate the laser if any of the cords are faulty or frayed. The laser should undergo routine inspection and maintenance per the Iridex Corporation manufacturer's recommendation and institutional standards. ®...

  • Page 19: Non Homogeneous Pattern Delivery

    Non Homogeneous Pattern Delivery WARNING The optical system in this unit has been designed to provide uniform laser energy deposition over the entire area of a focused spot. If proper focus of the laser spot on its intended target is not achieved, or if damage, contamination, or deterioration of the optical components has occurred, it is also possible to degrade this uniformity.

  • Page 20: Titration

    Please note that when retrieving a favorite that has been saved in titration mode, the values of the pattern parameters that are not allowed to be changed in titration will be restored to the defaults. Titration WARNING A single titration session at the very beginning of a treatment may be insufficient, as different areas of tissue may respond differently over the course of the treatment.

  • Page 21: Protecting Non-Target Tissues

    Protecting Non-target Tissues WARNING: LASER HAZARD Never place hands or other objects in the path of the laser beam. Severe burns could occur. Except during actual treatment, the system must always be in STANDBY mode. Maintaining the system in STANDBY mode prevents accidental laser exposure if the footswitch is inadvertently depressed.
  • Page 22 contact service. Early release of the footswitch will terminate the treatment beam before the complete pattern has been delivered. It is recommended that the pattern be completed by delivering the burns individually. DO NOT repeat the pattern at the same targeted tissue, as the pattern will start from the beginning, resulting in overlapping burns.
  • Page 23 It may take longer for the equipment to achieve a ready state in a low-temperature environment. It is the responsibility of the physician to verify that the aiming beam spot visualized through the slit lamp is the expected size. If the aiming beam size or pattern appears inappropriate or distorted, do not proceed with treatment.

  • Page 24: Additional Safety Considerations

    Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure. Iridex Corporation medical devices are solely for use by physicians trained in the operation of laser photocoagulation and associated delivery devices.

  • Page 25: Regulatory Compliance Safety Features

    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.

  • Page 26: Location Of Controls

    The laser systems are well-suited for treating the eye, because they have minimal effect on transparent tissues and materials. PASCAL Synthesis laser energy can be efficiently delivered to opaque structures of the eye through the transparent cornea, aqueous humor, lens and vitreous humor, allowing many conditions to be treated by non-invasive techniques.
  • Page 27 areas of the retina behind the iris or into the angle so that the trabecular meshwork can be 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 office, for in- patient or out-patient procedures.

  • Page 28: Contraindications

    Contraindications The following conditions are contraindications for performing laser trabeculoplasty: • Any corneal opacities, cataract formation and vitreous hemorrhage which can interfere with the laser surgeon’s view of the target structures • Aphakic eye with vitreous in the anterior chamber •...

  • Page 29: Adverse Effects And Complications

    Adverse Effects and Complications Posterior Segment Laser Procedures WARNING The most common complication of panretinal photocoagulation is increased macular edema usually with a concurrent decrease in visual acuity. In addition, blowout hemorrhages from the areas of neovascularization, particularly on the optic nerve, have been observed and may be caused by an increase in peripheral resistance secondary to photocoagulation or by an inadvertent valsalva maneuver by the patient.
  • Page 30 damage. WARNING Intraocular pressure elevations have been reported to occur in up to 53% of eyes when 360º of the trabecular meshwork has been treated with 100 spots at the initial session. Intraocular pressure rises occur most frequently from 1 to 2 hours following laser treatment, although they may occur several hours afterward.

  • Page 31: System Components

    System Components Laser Console 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 Control Panel Provides controls for selecting treatment parameters and displays for monitoring system information.

  • Page 32: Slit Lamp (Model Sl-Pa04)

    Aperture/slit length adjustment Joystick Illumination intensity adjustment PASCAL Synthesis Slit Lamp PA04 Footswitch Activates laser treatment beam when depressed 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: Micro Manipulator

    Micro Manipulator Provides auxiliary input for laser position. The aiming beam/treatment beam can be moved up/down/left/right in same direction as the micro manipulator (MM) moves. The movement is centered around any position offset (if any) introduced by the 3D controller. The micro manipulator will return to mechanical center when released.

  • Page 34: Controller (Purchased Separately)

    3D Controller (Purchased Separately) Provides auxiliary input for laser position and parameters. Parameters are adjusted by motion of controller. 3D Controller Action Slide up/down Slide left/right Side buttons (L/R) (U/D) (L/R) Pull (up) Tilt left/right Tilt up/down Rotate CW/CCW (U/D) 3D Controller Configurations Function Action...

  • Page 35: Lio (Laser Indirect Ophthalmoscope) - Optional Accessory

    LIO (Laser Indirect Ophthalmoscope) – optional accessory The LIO is an optional accessory to the PASCAL systems. Refer to the LIO operator manual for detailed safety and regulatory compliance information. ® PASCAL Synthesis Ophthalmic Scanning Laser Systems Page 35 of 141 88292-EN, Rev D...

  • Page 36: System Installation And Setup

    System Installation and Setup PASCAL Synthesis Ophthalmic Scanning Laser System is designed for installation and use in a darkened office or surgery room. Optimal system performance and viewing is achieved in low ambient light conditions. PASCAL Synthesis system installation and testing will be performed at your facility by Iridex Corporation-certified personnel.

  • Page 37: Connecting The System Components

    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 Panel Connections Fiber ports—for connection to LIO Key switch Emergency Stop ® PASCAL Synthesis Ophthalmic Scanning Laser Systems Page 37 of 141 88292-EN, Rev D...
  • Page 38 5 m (16 ft.). CAUTION USB Ports are not compatible with wireless devices. Use of the USB Ports with a wireless device cannot guarantee the performance of the wireless device or the Pascal Synthesis System. ®...

  • Page 39: System Start-Up And Shut-Down

    System Start-up and Shut-down Starting the System 1. Connect system to a wall power outlet. 2. Insert key into key switch. 3. Turn key switch to ON position. Key Switch Shutting Down the System (Standard Shut-down) From the Treatment screen: 4.

  • Page 40: Control Screen Description

    Control Screen Description Home Screen <Posterior Treatment> - press Posterior Treatment button and go to Treatment Screen <Anterior Treatment> - press Anterior Treatment button and go to Treatment Screen C <Select Physician> - press to display physicians D <Select Favorites> - press to display favorite settings E <System Setup>...

  • Page 41: Posterior Treatment Screen

    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 center of the treatment screen during system warm up. ® PASCAL Synthesis Ophthalmic Scanning Laser Systems Page 41 of 141 88292-EN, Rev D...
  • Page 42 Style 1.0 Status - press to select system status (STANDBY or READY mode) <Counter> - displays number of applications during treatment <Σn=0> - press to reset counter (Enable in preferences) Information - displays optional information and warning messages <Favorites> - press to open <Favorites> window, see the section “Favorites Window” <LENS>...
  • Page 43 Style 1.0 <Power> - press up/down buttons to adjust <Exposure> - press up/down buttons to adjust <Endpoint Mgmt> - press up/down buttons to adjust (EpM feature is available when activated) <EpM> - press to enable/disable Endpoint Management <LM> - press to toggle Landmark patterns <Rep Rate/Curve/Radius>...
  • Page 44 Style 1.0 <Spot Diameter> - press up/down buttons to adjust <Spacing> - press up/down buttons to adjust Primary Pattern - press to select pattern type Secondary Pattern - press to select pattern subset (when applicable) NOTE • Parameter controls only show on screens when applicable to the pattern selected. •...
  • Page 45 Style 1.0 <Titrate> - press to switch to single spot to perform test burns, adjustable up to 4 spots; press again to revert to prior laser mode <Fixation> - press to turn on fixation light (when applicable) <Outline> - press to enable full pattern outline (when applicable) <Auto>...

  • Page 46: Anterior Treatment Screen

    Anterior Treatment Screen Press < Anterior Treatment> button on the Home Screen to access the Anterior Treatment Screen. The system may also display warming up message at the center of the treatment screen during system warm up (see the section “Posterior Treatment Screen”). The Anterior Treatment screen is identical to the Posterior Treatment screen, except that the only available patterns are the PSLT 3 row, Array and Single Spot patterns.
  • Page 47 Style 1.0 <Titrate> - press to switch to single spot to perform test burns, adjustable up to 4 spots; press again to revert to prior laser mode <Power> - press up/down buttons to adjust <Exposure> - press up/down buttons to adjust Primary Pattern - press to select pattern type <Treatment Plan>...
  • Page 48 Style 1.0 <AIM> - press to turn on/off aiming beam in STANDBY <Spot Diameter> - press up/down buttons to adjust <Spacing/Curvature> - press up/down buttons to adjust (when Applicable) <Rep Rate> - press up/down buttons to adjust (when Applicable) NOTE •...

  • Page 49: Posterior Pattern Descriptions/Pattern Parameters

    Posterior Pattern Descriptions/Pattern Parameters There are three groups, fifteen posterior pattern types in total. The choice of pattern determines which parameters (e.g., radius, curvature, repetition rate, etc.) display on the touchscreen control panel, as well as the range of values for each parameter on the treatment screen.

  • Page 50: Single Spot

    Single Spot Primary pattern Secondary pattern Single Spot Not available General Use • PRP, retina tears, retina detachments, iridotomy, trabeculoplasty, LIO EPM % Pattern Spot Diameter Repetition Rate 50μm 100μm Single Spot Off, 1.0Hz to 8.0Hz 10 to 95 200μm 400μm The Single Spot pattern can be used with the slit lamp or an optional laser indirect ophthalmoscope (LIO).

  • Page 51: Array

    Array Primary pattern Secondary pattern 20ms Array General Use • PRP, retina tears and retina detachments EPM % Pattern Spot Diameter (μm) Spacing 50 (2x2 or smaller) 0.00Ø to 3.00Ø 20 ms Array 10 to 95 0.00Ø to 1.50Ø The 20 ms Array pattern is selectable in a variety 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.
  • Page 52 Endpoint Management Features Pattern Endpoint Management Endpoint Management Endpoint Management Type Off or Disabled On/ Landmark On On/ Landmark Off All full-power spots (red- All full-power spots (red- All endpoint spots 100%) 100%) (orange-xx %) 1x2, 2x1, Two full-power spots (red- Single- All full-power spots (red- 100%);...
  • Page 53 Hexagon Primary pattern Secondary pattern 20ms Hexagon General Use • PRP, retina tears and retina detachments Spot Diameter EPM % Pattern # of Spots Spacing (μm) 7, 19 and 37 0.00Ø to 3.00Ø 7, 19 0.00Ø to 3.00Ø 0.00Ø to 2.50Ø 20 ms Hexagon 10 to 95 0.00Ø...
  • Page 54 Endpoint Management Features # of Endpoint Management Endpoint Management Endpoint Management Spots Off or Disabled On/ Landmark On On/ Landmark Off Six full-power spots (red- All full-power spots (red- 100%); remaining All endpoint spots 100%) endpoint spots (orange-xx (orange-xx %) ®...
  • Page 55 Triple Arc Primary pattern Secondary pattern 20ms Triple Not available General Use • PRP, retina tears, retina detachments Spot Exposure Pattern Diameter Spacing Curvature EPM % Time (ms) (μm) 0.25Ø to 3.00Ø 20 ms Triple Arc 15 to 30 0.00 to 2.00 10 to 95 0.25Ø...
  • Page 56 Endpoint Management Features Pattern Endpoint Management Endpoint Management Endpoint Management Type Off or Disabled On/ Landmark On On/ Landmark Off Four full-power spots All full-power spots (red- (red- 100%); remaining All endpoint spots 100%) endpoint spots (orange-xx (orange-xx %) Example: Example: Example: Triple...
  • Page 57 Single Spot Primary pattern Secondary pattern 20ms Single Not available Spot See the section “Posterior Pattern Description/Pattern Parameters” for the detailed information on the Single Spot pattern. ® PASCAL Synthesis Ophthalmic Scanning Laser Systems Page 57 of 141 88292-EN, Rev D...
  • Page 58 Wedge Primary pattern Secondary pattern 20ms Wedge General Use • PRP, retina tears, retina detachments Exposure Time Spot Diameter Pattern Spacing EPM % (ms) (μm) 0.00Ø to 3.00Ø 20 ms Wedge 15 to 30 0.00Ø to 2.00Ø 10 to 95 0.00Ø...
  • Page 59 Secondary pattern Primary pattern 20ms Arc General Use • PRP, retina tears, retina detachments Radius Pattern Spot Diameter (μm) Spacing (Inner ring) 0.00Ø 500μm to 1400μm 0.25Ø 500μm to 1600μm 20 ms Arc 0.50Ø 500μm to 1900μm 0.00Ø to 0.50Ø 500μm to 2000μm 0.00Ø...

  • Page 60: Triple Ring

    Triple Ring Primary pattern Secondary pattern 20ms Triple Not available Ring General Use • PRP, retina tears, retina detachments Radius Pattern Spot Diameter (μm) Spacing (Inner ring) 0.50Ø 500μm 0.00Ø 500μm to 600μm 20 ms Triple Ring 0.25Ø 500μm to 700μm 0.50Ø...

  • Page 61: Line

    Line Primary pattern Secondary pattern 20ms Line Not available General Use • PRP, retina tears, retina detachments, focal laser EPM % Pattern Spot Diameter (μm) Spacing 20 ms Line 0.00Ø to 3.00Ø 10 to 95 The Line pattern is selectable in nine sizes (2 to 10 spots) and twenty-four orientations. Spot diameter and spacing settings are also adjustable.
  • Page 62 Endpoint Management Features Pattern Endpoint Management Off Endpoint Management Endpoint Management Type or Disabled On/ Landmark On On/ Landmark Off All full-power spots (red- All full-power spots (red- All endpoint spots 100%) 100%); (orange-xx %) Examples: Examples: Examples: 1x2 lines Two full-power spots (red- All full-power spots (red- 100%);...
  • Page 63 Octants Primary pattern Secondary pattern 10ms Octants General Use Radius Pattern Spot Diameter Spacing EPM % (Inner ring) 1100µm to 0.25Ø 1600µm 1100µm to 0.50Ø 1500µm 15 to 95 1100µm to 100μm 1.00Ø (Exposure 10ms) 1400µm 10 ms Octants 1100µm to 1.50Ø...
  • Page 64 Auto Advance Feature The Auto Advance Feature is available only for the A+B format. If the Auto Advance feature is enabled, the selected pattern is delivered when you press the footswitch, after which the system automatically advances to the next pattern. The orientation is selectable in clockwise and counter-clockwise on the Physician Preferences.
  • Page 65 Endpoint Management Features Pattern Endpoint Management Off Endpoint Management Endpoint Management Type or Disabled On/ Landmark On On/ Landmark Off Two full-power spots (red- All full-power spots (red- 100%) per octant; All endpoint spots 100%) remaining endpoint spots (orange-xx %) (orange-xx %) Format All full-power spots (red-...
  • Page 66 Enhanced Octants Primary pattern Secondary pattern 10ms New PC Octants Not available (Enhanced Octants) General Use Radius Radius Spot Pattern Spacing (Inner (Outer EPM % Diameter radius) radius) 500µm to 700µm to 0.00Ø 2000µm 2200µm 0.25Ø to 500µm to 800µm to 1.00Ø...
  • Page 67 System Automatically Advances Pattern Clockwise when 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 Preferences. NOTE • When auto-advanced mode is not enabled, the treated segment spots will also be marked as hollow for enhanced octant pattern.
  • Page 68 Endpoint Management Features Endpoint Management Off Endpoint Management On/ Endpoint Management On/ or Disabled Landmark On Landmark Off Four full-power spots (red- All full-power spots (red- All endpoint spots (orange-xx 100%) per octant; remaining 100%) endpoint spots (orange-xx %) ® PASCAL Synthesis Ophthalmic Scanning Laser Systems Page 68 of 141...
  • Page 69 Enhanced Octants Primary pattern Secondary pattern 15ms EpM Enhanced Not available Octants See the section “Posterior Pattern Description/Pattern Parameters” for the detailed information 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 Preferences screen, it allows the user to transition to the selected pattern automatically after treating the last subset of Octants and to STANDBY mode.
  • Page 70 NOTE • The LM will be automatically turn off for any auto transitioned pattern after 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 completing one segment for EpM enhanced octants pattern.
  • Page 71 Endpoint Management Features Endpoint Management On/ Endpoint Management On/ Landmark On Landmark Off Four full-power spots (red- All endpoint spots (orange-xx 100%) per octant; remaining endpoint spots (orange-xx %) NOTE • The EpM is always ON for all patterns in EpM group. It cannot be disabled. ®...
  • Page 72 Array Primary pattern Secondary pattern 15ms EpM Array See the section “Posterior Pattern Description/Pattern Parameters” for the detailed information on the Array pattern. Endpoint Management Features Pattern Endpoint Management Endpoint Management On/ Type On/ Landmark On Landmark Off All full-power spots (red- All endpoint spots (orange-xx 100%) 1x2,...
  • Page 73 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 group. It cannot be enabled. ® PASCAL Synthesis Ophthalmic Scanning Laser Systems Page 73 of 141 88292-EN, Rev D...

  • Page 74: Hexagon

    Hexagon Primary pattern Secondary pattern 15ms EpM Hexagon See the section “Posterior Pattern Description/Pattern Parameters” for the detailed information on the Hexagon pattern. Endpoint Management Features # of Endpoint Management Endpoint Management Spots On/ Landmark On On/ Landmark Off Six full-power spots (red- 100%);...

  • Page 75: Single Spot

    Single Spot Primary pattern Secondary pattern 15ms EpM Not available Single Spot General Use • PRP, retina tears, retina detachments, iridotomy, trabeculoplasty, LIO Pattern Spot Diameter (μm) EPM % 100 μm Single Spot 10 to 95 200 μm The Single Spot pattern can be used with the slit lamp or an optional laser indirect ophthalmoscope (LIO).
  • Page 76 NOTE • The Endpoint Management feature is not available with the LIO. • The Endpoint Management feature is only available for EpM ON and LM OFF mode ® PASCAL Synthesis Ophthalmic Scanning Laser Systems Page 76 of 141 88292-EN, Rev D...

  • Page 77: Anterior Pattern Descriptions/Pattern Parameters

    Anterior Pattern Descriptions/Pattern Parameters There are two 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/Parameters" for the detailed information on the Single Spot pattern.

  • Page 78: Array

    Array Primary pattern Secondary pattern Array General Use • retina tears, retina detachments Pattern Spot Diameter (μm) Spacing 50 (2x2 or smaller), 0.00Ø to 3.00Ø Array 0.00Ø to 1.50Ø The Array (20 ms default) pattern is selectable 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.

  • Page 79: Pattern Titration

    Pattern Titration <Titrate>— press to switch to Titrate Mode to perform test lesions in a linear pattern, adjustable from 1 to 4 spots; press again to revert to prior laser mode Power Display – Maximum and Minimum are displayed when 2 or more applications are selected.
  • Page 80 Refer to Warning Section for Pattern Titration Warning Information. NOTE • The pattern selection bar is disabled when Titration is ON. ® PASCAL Synthesis Ophthalmic Scanning Laser Systems Page 80 of 141 88292-EN, Rev D...

  • Page 81: Endpoint Management With Landmark Patterns (Optional)

    Endpoint Management with Landmark Patterns (optional) Endpoint Management with Landmarks ON Endpoint Management with Landmarks OFF EpM (Endpoint Management): Refers to a software feature that allows delivery of laser energy which is a user-selected percentage of a laser dose pre-determined by titration. This pre-determined titration dose is the “100%”...
  • Page 82 moved across the retina, the user can adjust the laser power to maintain the same lesion appearance as the original titration burn. ® PASCAL Synthesis Ophthalmic Scanning Laser Systems Page 82 of 141 88292-EN, Rev D...

  • Page 83: System Software Setup

    System Software Setup System Setup Screen <Patient Information> - Enable/Disable Patient information pop-up prior to treatment <Counter Reset> - Enable/Disable resettable counter in <Treatment Screen> <Enable Treatment Time> - select to display treatment time and date on Treatment screen and report <Surgical Timeout>...
  • Page 84 <Report> - press to select report format <Time Format> - press to select time format <Date Format> - press to select date format <Additional Features> - Enter activations codes for optional upgrades <Home> - press to go to Home screen <?>...

  • Page 85: Patient Information Feature

    Patient Information Feature The Patient Information feature allows you to include patient identification, such as patient name, number, and date of birth, on Treatment screen and Treatment Report. Press the Enable Patient Information checkbox on the System Setup screen to enable the Patient Information feature.
  • Page 86 ® PASCAL Synthesis Ophthalmic Scanning Laser Systems Page 86 of 141 88292-EN, Rev D...

  • Page 87: Progressive Titrate

    Progressive Titrate When the Progressive Titrate feature is enabled, it allows you to output an aiming beam pattern with positions that are offset from the delivered with 1.5 spot diameter spacing between the titration pattern and the blinking aiming spots. If the titration pattern spots have reached at the top of the FOV, the blinking aiming spots stay at the same position of the titration pattern spots.

  • Page 88: Edit Physician Preferences> Window

    <Edit Physician Preferences> Window Normal Feature <Ocular Setting Reminder> - displays settings to remind to set ocular power before treatment. < Advance Direction> - select direction to advance the pattern <3D Controller Mode> - set to Advanced or Default configuration <Transition>...

  • Page 89: Contact Lens Selection Screen

    Contact Lens Selection Screen <Add>—press to enter custom lens <Delete>—press to delete lens <Home>—press to go to Home screen <Reset>—discard changes Up/Down—press to scroll ® PASCAL Synthesis Ophthalmic Scanning Laser Systems Page 89 of 141 88292-EN, Rev D...

  • Page 90: Favorites Window

    Favorites Window Press the favorite icon in the posterior/anterior treatment screen to open the Favorite Window. Display 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 the popup.
  • Page 91 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 area will be cleared. ® PASCAL Synthesis Ophthalmic Scanning Laser Systems Page 91 of 141 88292-EN, Rev D...

  • Page 92: Edit Favorites> Window

    <Edit Favorites> Window Press the “Edit” button to enter the Edit mode. Once a favorite is selected, the “Rename”,“Remove”, “Save” and “Move” buttons are enabled. <Done> - press to finish the Edit of Favorite Window <Rename> - press to change the name of the selected favorite <Remove>...
  • Page 93 Press the “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 previously selected favorite to. For example, select “Single 1”.

  • Page 94: Treatment Report Window

    Treatment Report Window If you have enabled reports on the System Setup screen (see “System Setup Screen” section), the Treatment Report Window displays when you press the End Treatment button at the completion of each patient treatment session. <Page> - press to show the previous page and to show the next page (when applicable)
  • Page 95 • The “Export” is disabled if no USB drive is plugged into the console’s USB port. ® PASCAL Synthesis Ophthalmic Scanning Laser Systems Page 95 of 141 88292-EN, Rev D...

  • Page 96: Export Treatment Report

    Export Treatment Report The Export button will be enabled if a USB drive is plugged into the console’s USB port and detected by the Synthesis software. If the connected USB drive doesn’t meet the requirements, the “Export” button is still disabled and the system will pop up the message. All the reports exported from Synthesis will be stored in the ‘synthesis_report’...

  • Page 97: Procedure To Prepare The Usb Drive Before The First Time Use

    Procedure to prepare the USB drive before the first time use Purchase a new USB drive of USB 2.0 or USB 3.0 with at least 8GB in size. On a Windows 10 PC, open Windows Explorer, plug in the USB drive, identify the newly added drive.

  • Page 98: Treatment Reports

    Treatment Reports At the completion of each patient session, you can view a Treatment 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 Report •...
  • Page 99 Sample Posterior Info Treatment Report ® PASCAL Synthesis Ophthalmic Scanning Laser Systems Page 99 of 141 88292-EN, Rev D...
  • Page 100 Sample Posterior Advanced Info Treatment Report ® PASCAL Synthesis Ophthalmic Scanning Laser Systems Page 100 of 141 88292-EN, Rev D...
  • Page 101 Sample Anterior Basic 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 of the TM were retreated during a treatment, these areas will be visually depicted with a solid circle.

  • Page 102: Intraoperative Instructions

    Intraoperative Instructions Slit Lamp Treatment Procedure Perform the following procedure: 1. Verify that the slit lamp eyepieces are adjusted to your settings. 2. Position the patient at the slit lamp with their chin on the chin rest and forehead pressed firmly against the head rest.

  • Page 103: Lio Treatment Procedure

    LIO Treatment Procedure Perform the following procedure in conjunction with the instructions in the Laser Indirect Ophthalmoscope (LIO) operator manual. 1. Select the Port where the LIO is connected. 2. Select READY mode. The aiming beam turns on. 3. Select the aiming beam intensity. 4.

  • Page 104: Between Patient Treatments

    Between Patient Treatments At the completion of each patient treatment: 1. Press <End Treatment>to exit the Treatment screen. If the treatment report feature is enabled, the Treatment Report window displays. Otherwise, the Home screen displays. NOTE If no laser shots were fired during the treatment session, pressing <End Treatment>returns the system to the Home screen whether or not the treatment report feature is enabled.

  • Page 105: Maintenance Instructions

    Annual Maintenance Preventive maintenance, safety, power and calibration checks should be performed annually by Iridex Corporation-certified personnel to ensure proper laser performance. System Repair All repairs should be performed by certified personnel to ensure proper system performance.

  • Page 106: Replacing The Fuses

    Replacing the Fuses To change the power receptacle fuses: 1. Ensure the key switch is in the OFF position. 2. Unplug the main power cable from 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.

  • Page 107: System Specifications

    System Specifications [Specifications are subject to change without notice.] Treatment Beam PASCAL Synthesis PASCAL Synthesis (532 nm) (577 nm) Type Optically Pumped Semiconductor Laser (OPSL) Wavelength (nm) 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)
  • Page 108 Electrical Requirements PASCAL Synthesis PASCAL Synthesis (532 nm) (577 nm) 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...
  • Page 109 Environmental Requirements (operating) PASCAL Synthesis PASCAL Synthesis (532 nm) (577 nm) Maximum altitude 2,000m (6562 ft.) Operating temperature 15° – 35°C (59° – 95°F) 15° to 25°C: 85% (non-condensing) Maximum humidity 25° to 35°C: 60% (non-condensing) Atmospheric pressure range 80.0 – 106.0 kPa...

  • Page 110: Troubleshooting Guide

    Troubleshooting Guide If the instrument fails to operate properly, this troubleshooting guide will help you to locate and correct the malfunction. Should a major malfunction occur, contact service. First, check for the following items. If none of these solutions remedies the problem, consult the service manual for additional troubleshooting options.

  • Page 111: System Does Not Turn On

    System does not turn on. Probable Cause: System is not plugged in. Suggestion: Plug in system. Verify power cable is well seated in wall outlet and in main power receptacle. Probable Cause: Wall circuit breaker is in off position. Suggestion: Turn on wall circuit breaker.
  • Page 112 3D Controller not functioning. Probable 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 be changed. Trouble Adding/Removing Favorites. Probable Cause: Favorite’s Database Update Error.
  • Page 113 No aiming beam is present when in READY mode and/or no laser treatment light is delivered when the footswitch is depressed and/or the beams are of poor quality. Probable Cause: Laser is in STANDBY mode, not READY mode. Suggestion: Select READY mode on control panel. Probable Cause: Footswitch is not connected.

  • Page 114: Error Messages

    Error Messages Error States If error occurs regularly, contact service. Critical Error implies a safety issue that requires the system to immediately go to a safe state. System restart may be required. Clearable Error indicates a problem with the system that requires that the system be put into a safe state until the error is acknowledged by the user.
  • Page 115 Code Message Critical Clearable Warning Description Action BRF Treatment Check fan and ventilation. Laser module treatment Temperature Low Allow system to warm up. temperature is low (Moderate) BRF Treatment Check fan and ventilation. Laser module treatment Temperature Low Allow system to warm up. temperature is severely low (Severe) BRF Treatment...
  • Page 116 Code Message Critical Clearable Warning Description Action OPSL LBO Temperature during Allow system to cool. Treatment LBO treatment exceeds Reconfigure treatment Temperature Over parameters if Laser module maximum Maximum necessary allowable value Red Laser modules Base Treatment Allow system to cool. Temperature during treatment Temperature Over Reconfigure treatment...
  • Page 117 Code Message Critical Clearable Warning Description Action User to select End Treatment and Return to the Home Screen. Red 60µm Treatment Laser output is 20% under the Re-access treatment screen Local Light Under expected value and reconfigure treatment (Low) parameters. If error repeats- End Treatment and call Service User to select End...
  • Page 118 Code Message Critical Clearable Warning Description Action Re-access treatment screen and reconfigure treatment parameters. If error repeats- End Treatment and call Service Unexpected local Laser output was detected when it Verify device connections. light (OPSL Aiming) was not expected Unexpected local Laser output was detected when it Verify device connections.
  • Page 119 Code Message Critical Clearable Warning Description Action Verify connection to SLA Detached The SLA is not attached slit lamp. The pattern cannot be modified at Press Ready button on this time. Certain patterns can only Touchscreen to return Pattern Locked be modified in Standby mode.
  • Page 120 Code Message Critical Clearable Warning Description Action detect it. to reset. Reboot. Call service if error persists. The calibration file is missing, not Invalid Attachment Reboot. readable, or incomplete. Check the Calibration Call service if error persists. log file for the exact problem. User to select End Treatment and Return to This warning occurs when a partial...

  • Page 121: Calibration Procedure

    Calibration Procedure Regulatory agencies require that manufacturers of US FDA CDRH Class II and IV and European IEC 60825 Class 2 and 4 medical lasers supply customers with power calibration instructions. Calibration must be performed by an engineer or technician qualified to work on energized electronic laser equipment.

  • Page 122: System Relocation Instructions

    System Relocation Instructions To move the system to another location: 1. Ensure that the wall circuit breaker is turned off and the key switch is in the OFF position. 2. Remove the power cable from the wall outlet and the system main power receptacle. 3.

  • Page 123: Instructions For Use

    Instructions for Use Intended Use Environment The intended Use Environment of the laser system is as follows: • Professional Healthcare Facility Environment • Physician offices, clinics, multiple treatment facilities, hospitals except for near active HF surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging, where the intensity of EM disturbances is high.
  • Page 124 Devices applicable to the use in patient environment: • Insulation transformer Radius 1.5 m 2.5 m 1.5 m 1.5 m 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. •...

  • Page 125: Electromagnetic Compatibility

    Electromagnetic Compatibility Applicable to PASCAL Synthesis Laser Systems with serial numbers starting with “80” (eg 80xxxxxx). This product conforms to the EMC standard (IEC 60601-1-2: 2014). The expected electromagnetic environment for the whole life cycle is professional healthcare facility environment.
  • Page 126 NOTE PASCAL Synthesis Ophthalmic Scanning Laser System have been designed and tested to comply with IEC 60601-1-2:2014 requirements for EMC with other devices. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules.
  • Page 127 Guidance and manufacturer's declaration - electromagnetic emissions The PASCAL Synthesis Ophthalmic Scanning Laser System is intended for use in the electromagnetic environment specified below. The customer or the user of the PASCAL Synthesis Ophthalmic Scanning Laser System should assure that it is used in such an environment.
  • Page 128 Guidance and manufacturer's declaration - electromagnetic immunity The PASCAL Synthesis Ophthalmic Scanning Laser System is intended for use in the electromagnetic environment specified below. The customer or the user of the PASCAL Synthesis Ophthalmic Scanning Laser System should assure that it is used in such an environment.
  • Page 129 Guidance and manufacturer's declaration - electromagnetic immunity The PASCAL Synthesis Ophthalmic Scanning Laser System is intended for use in the electromagnetic environment specified below. The customer or the user of the PASCAL Synthesis Ophthalmic Scanning Laser System should assure that it is used in such an environment.
  • Page 130 The table below shows the proximity electromagnetic field from radio communication equipment. Immunity Test Band Maximum Distance frequency Equipment Modulation test value [MHz] output[W] [MHz] [V/m] Pulse 380- modulation TETRA 400 18Hz GMRS 460 FM +/-5kHz 430- FRS 460 1kHz sine Pulse 704- LTE Band 13, 17...

  • Page 131: Ophthalmology References

    Ophthalmology References 1. The Diabetic Retinopathy Study Research Group. Photocoagulation Treatment of Proliferative Diabetic Retinopathy Clinical application of diabetic retinopathy-study (DRS) findings, DRS report number 8. Ophthalmology 1981; 88:583-600. 2. Quigley HA. Long Term Follow-up of Laser Iridotomy. Ophthalmology 1981; 88:218- 114 3.

  • Page 132: General Information On Usage

    General information on Usage Intended Patient Population The patient who undergoes an examination by this equipment must maintain concentration during the treatment and adhere to the following instructions: • Fix the face to the chinrest, forehead rest. • Keep the eye open. •...

  • Page 133: Warranty Information

    Iridex Corporation). There are certain other limitations that apply to Iridex Corporation’s warranty. Reference should be made to the terms and conditions of sale attached to Iridex Corporation’s purchase agreement. Warranty terms may be different by region based on contractual agreements.

  • Page 134: Decontamination Of Returned Equipment

    Decontamination of Returned Equipment To comply with United States postal and transportation law, equipment shipped to Iridex Corporation for repair or return must be properly decontaminated with a chemical germicide that is commercially available and cleared for sale as a Hospital Disinfectant. To ensure that all equipment has been properly decontaminated, a signed Decontamination Certificate (provided in this section) must be enclosed in the package.

  • Page 135: Decontamination Certification

    Hospital Disinfectant and is clean and free from biohazards, including – but not limited – human or animal blood, tissue or tissue fluids or components thereof. The undersigned also agrees to reimburse Iridex Corporation for any costs incurred in decontaminating the enclosed equipment, in the event said item is received by Iridex Corporation in a contaminated condition.

  • Page 136: Disposal

    This product contains a coin cell. You cannot replace batteries by yourself. When you need to replace and/or dispose batteries, contact your dealer or Iridex listed on the back cover. EU Battery Directive NOTE This symbol is applicable for EU members states only.

  • Page 137: Pattern Scanning Laser Trabeculoplasty (Pslt) (Optional)

    Pattern Scanning Laser Trabeculoplasty (PSLT) (optional) Indications for Use: Pattern Scanning Laser Trabeculoplasty (PSLT) software is intended for use with the PASCAL Synthesis for procedures in trabeculoplasty in Open Angle Glaucoma. Description: Pattern Scanning Laser Trabeculoplasty or PSLT is an advanced tissue-sparing laser treatment for reducing intraocular pressure.
  • Page 138 Treatment Plan 180-degree 360-degree NOTE For use with a gonioscopic lens of 1.0X magnification. The PSLT pattern appears in the center of the field of 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>”...

  • Page 139: Anterior Pattern Descriptions/Pattern Parameters

    Anterior Pattern Descriptions/Pattern Parameters There are three anterior pattern types. 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/Parameters" for the detailed information on the Single Spot pattern.

  • Page 140: Array

    Array Primary pattern Secondary pattern Array General Use • retina tears and retina detachments Pattern Spot Diameter (μm) Spacing 50 (2x2 or smaller), 0.00Ø to 3.00Ø Array 0.00Ø to 1.50Ø The Array (20 ms default) pattern is selectable 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.

  • Page 141: Pascal ® Synthesis Ophthalmic Scanning Laser Systems

    PSLT 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 <Rotate> button at the bottom of the screen. The pattern spacing is fixed, but curvature is adjustable.

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