1. Manuals
  2. Brands
  3. Iridex Manuals
  4. Medical Equipment
  5. PASCAL Synthesis TwinStar
  6. Operator's manual

Iridex PASCAL Synthesis TwinStar Operator's Manual

Ophthalmic scanning laser system
Hide thumbs
Table of Contents

Advertisement

Quick Links

Download this manual
PASCAL
(SL-PA04 577 nm & 638 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"
®
Synthesis™ TwinStar
Operator Manual
Iridex Corporation
1212 Terra Bella Avenue
Mountain View, CA 94043
USA
Office: +1.650.940.4700
Fax: +1.650.962.0486
www.iridexretina.com

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the PASCAL Synthesis TwinStar and is the answer not in the manual?

Questions and answers

Subscribe to Our Youtube Channel

Related Manuals for Iridex PASCAL Synthesis TwinStar

Summary of Contents for Iridex PASCAL Synthesis TwinStar

  • Page 1 ® PASCAL Synthesis™ TwinStar (SL-PA04 577 nm & 638 nm) Ophthalmic Scanning Laser System Operator Manual European Authorized Representative Iridex Corporation Obelis 1212 Terra Bella Avenue 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...
  • Page 2 Intentionally left blank ® PASCAL Synthesis TwinStar Ophthalmic Scanning Laser Systems Page 2 of 142 88293-EN, Rev C...
  • Page 3 Iridex Corporation. Permitted copies must carry the same proprietary and copyright notices as were affixed to the original under the law. Copying includes translation into another language.
  • Page 4 Intentionally left blank ® PASCAL Synthesis TwinStar Ophthalmic Scanning Laser Systems Page 4 of 142 88293-EN, Rev C...

  • Page 5: Introduction

    INTRODUCTION INTENDED USE / INDICATIONS FOR USE ® PASCAL Synthesis TwinStar Ophthalmic Scanning Laser System is intended for use to perform single-spot photocoagulation in the posterior segment (retina, choroid) and in the anterior segment (iris, trabecular meshwork) as well as pattern-scanning photocoagulation in the non-macular retina of the eye.
  • Page 6 CEC and NEC requirements. The warranty is void if any of these warnings are disregarded. Iridex Corporation reserves the right to make changes to the device(s) herein. Device(s), therefore, may not agree in detail with the published design or specifications. All specifications are subject to change without notice.

  • 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 Operator Manual Symbol Definitions .................. 16 General Safety and Regulatory Information ................ 16 Ocular Protection ........................
  • Page 8 System Software Setup ....................... 83 System Setup Screen .................... 83 Contact Lens Selection Screen ................88 Favorites Window ....................89 Treatment Report Window ..................93 Export Treatment Report ..................94 Treatment Reports ....................96 Intraoperative Instructions ....................100 Slit Lamp Treatment Procedure ................100 Between Patient Treatments ................
  • Page 9 Intentionally left blank ® PASCAL Synthesis TwinStar Ophthalmic Scanning Laser Systems Page 9 of 142 88293-EN, Rev C...

  • Page 10: Cautions & Warnings

    CAUTIONS & WARNINGS ® PASCAL Synthesis TwinStar Ophthalmic Scanning Laser Systems Page 10 of 142 88293-EN, Rev C...

  • Page 11: Disclaimer

    Disclaimer Calibration of the PASCAL Synthesis TwinStar (577 nm & 638 nm) 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...
  • Page 12 Laser Radiation Caution Label, includes: Laser Emission Warning PASCAL Synthesis TwinStar 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 Prescription Only European Representative...
  • Page 13 Danger label, includes: • Laser Emission Warning • Wavelength • Power • Laser Class PASCAL Synthesis TwinStar (577 nm & 638 nm) USB Connections Wireless USB Caution Remote Door Interlock Connection Footswitch Connection Laser Aperture Label Laser Emission Warning Warning, Hot Surface Label Warning, this surface may be extremely hot.
  • Page 14 General Warning Label Additional Labels Footswitch Ingress Protection “Hospital Grade” Cord Grounding Instructions ® PASCAL Synthesis TwinStar Ophthalmic Scanning Laser Systems Page 14 of 142 88293-EN, Rev C...
  • Page 15 Intentionally left blank ® PASCAL Synthesis TwinStar Ophthalmic Scanning Laser Systems Page 15 of 142 88293-EN, Rev C...

  • Page 16: 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...

  • Page 17: Ocular Protection

    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. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

  • Page 18: Laser Safety Eyewear

    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. Using any of the larger patterns while the slit lamp magnification is set to 32X, may result in the pattern overfilling the visual field.

  • Page 19: 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 20: Fiber Optic Cable Assembly

    aiming laser spots should provide suitable indication of the level of uniformity attainable in any given system configuration, and treatment should proceed only when the user is satisfied as to the level of laser deposition uniformity by observation of properly focused aiming laser spots.

  • Page 21: Titration

    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. Uniform tissue response should be continuously assessed by the end-user and re-titration may be necessary during the procedure.

  • Page 22: Operational Safety

    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 23 When a pattern with multiple spots is selected, use caution when operating with a multiple mirror contact lens. Do not overfill the mirror with the pattern and ensure that you have visualization of the complete pattern and the area to be treated prior to laser treatment. Do not use any contact lens with a laser spot magnification of <0.94.
  • Page 24 inappropriate or distorted, do not proceed with treatment. Readjust the slit lamp focus. If the problem persists, contact service. It is the responsibility of the physician to select the appropriate power and treatment location. The lowest practical setting should always be used to achieve the desired clinical outcome.

  • Page 25: 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 26: Regulatory Compliance Safety Features

    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).

  • Page 27: Ophthalmic Applications

    Ophthalmic Applications PASCAL Synthesis TwinStar Ophthalmic Scanning Laser System is used to treat ocular diseases in both the posterior and anterior chambers of the eye. The laser systems are well-suited for treating the eye, because they have minimal effect on transparent tissues and materials.
  • Page 28 Laser energy is delivered to opaque structures within the eye through a slit lamp that has been specially adapted for use as a laser delivery system. The delivery system includes a lens system to focus the laser energy and vary the size of the laser spot in the plane of observation of the slit lamp.

  • Page 29: 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 30: 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 31 Pupillary distortion may be encountered if the iris root or peripheral iris has been treated. This distortion may or may not be permanent, depending on the severity of the accidental damage. WARNING Intraocular pressure elevations have been reported to occur in up to 53% of eyes when 360º...

  • Page 32: System Components

    System Components Laser Console Houses the key switch, emergency laser stop button, fiber ports, laser fiber and electronics cable, and combined 577nm & 638nm lasers, control electronics and power supply. Laser delivery of the 638nm wavelength is for Slit Lamp only (not available through front fiber ports).

  • Page 33: Slit Lamp (Model Sl-Pa04)

    Slit Lamp (model SL-PA04) Integrated slit lamp connection. Service personnel will connect laser system to slit lamp. Eyepieces Fixation lamp Head rest Magnification adjustment Chinrest Micro Manipulator Slit width Power Knob adjustment Filter wheel Aperture/slit length adjustment Joystick Illumination intensity adjustment PASCAL Synthesis Slit Lamp PA04 Footswitch...

  • Page 34: 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 35: 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 36 Intentionally left blank ® PASCAL Synthesis TwinStar Ophthalmic Scanning Laser Systems Page 36 of 142 88293-EN, Rev C...

  • Page 37: System Installation And Setup

    PASCAL Synthesis TwinStar 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 TwinStar system installation and testing will be performed at your facility by Iridex Corporation- certified personnel.

  • Page 38: 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 Key switch Emergency Stop ® PASCAL Synthesis TwinStar Ophthalmic Scanning Laser Systems Page 38 of 142 88293-EN, Rev C...
  • Page 39 Rear Panel Connections LCD control panel receptacle USB ports—3D Controller, and touch screen monitor Monitor power receptacle Footswitch receptacle Door interlock receptacle—must be inserted for laser to operate Main power cable receptacle NOTE If using an external door interlock, a qualified electrical professional must install the external switch, and the total length of the cable should not exceed 5 m (16 ft.).

  • Page 40: 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: 1.

  • Page 41: Control Screen Description

    Control Screen Description Home Screen <Posterior Treatment> - press Posterior Treatment button and to 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 <System Setup>...

  • Page 42: 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 TwinStar Ophthalmic Scanning Laser Systems Page 42 of 142 88293-EN, Rev C...
  • Page 43 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”...
  • Page 44 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 45 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 46 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 47: 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 PSLT 3 row, the Array and Single Spot.
  • Page 48 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 49 Style 1.0 A <AIM> - press to turn on/off aiming beam in STANDBY B <Spot Diameter> - press up/down buttons to adjust C <Spacing/Curvature> - press up/down buttons to adjust (when Applicable) D <Rep Rate> - press up/down buttons to adjust (when Applicable) NOTE •...

  • Page 50: 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 51 Single Spot Primary pattern Secondary pattern Single Spot Not available General Use • PRP, retina tears, retina detachments, iridotomy, trabeculoplasty EPM % Pattern Spot Diameter Repetition Rate 50μm 100μm Off, Single Spot 10 to 95 1.0Hz to 8.0Hz 200μm 400μm The Single Spot pattern can be used with the slit lamp.
  • Page 52 Array Primary pattern Secondary pattern 20ms Array General Use • PRP, retina tears, 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 53 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 54 Hexagon Primary pattern Secondary pattern 20ms Hexagon General Use • PRP, retina tears, 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 55 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 56 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 57 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 58 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 TwinStar Ophthalmic Scanning Laser Systems Page 58 of 142 88293-EN, Rev C...
  • Page 59 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 60 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 61 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 62 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 63 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 64 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 65 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 66 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 67 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 68 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 69 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 TwinStar Ophthalmic Scanning Laser Systems Page 69 of 142...
  • Page 70 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 71 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 72 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 73 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 74 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 TwinStar Ophthalmic Scanning Laser Systems Page 74 of 142 88293-EN, Rev C...
  • Page 75 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 76 Single Spot Primary pattern Secondary pattern 15ms EpM Not available Single Spot General Use • PRP, retina tears, retina detachments, iridotomy, trabeculoplasty 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. Spot diameter and repetition rate settings are adjustable.

  • Page 77: Anterior Pattern Descriptions/Pattern Parameters

    Anterior Pattern Descriptions/Pattern Parameters There are two anterior pattern types. The Single Spot patterns the Array (20msdefault) 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 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 more applications are selected.
  • Page 80 NOTE • The pattern selection bar is disabled when Titration is ON. ® PASCAL Synthesis TwinStar Ophthalmic Scanning Laser Systems Page 80 of 142 88293-EN, Rev C...

  • 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 application is moved across the retina, the user can adjust the laser power to maintain the same lesion appearance as the original titration burn. ® PASCAL Synthesis TwinStar Ophthalmic Scanning Laser Systems Page 82 of 142 88293-EN, Rev C...

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

  • Page 88: Contact Lens Selection Screen

    Contact Lens Selection Screen <Add>—press to enter custom lens <Delete>—press to delete lens B <Home>—press to go to Home screen C <Reset>—discard changes D Up/Down—press to scroll ® PASCAL Synthesis TwinStar Ophthalmic Scanning Laser Systems Page 88 of 142 88293-EN, Rev C...

  • Page 89: 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 90 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 TwinStar Ophthalmic Scanning Laser Systems Page 90 of 142 88293-EN, Rev C...
  • Page 91 <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. A <Done> - press to finish the Edit of Favorite Window B <Rename> - press to change the name of the selected favorite C <Remove>...
  • Page 92 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 93: 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 94: 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 95 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 96: 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 97 Sample Posterior Info Treatment Report ® PASCAL Synthesis TwinStar Ophthalmic Scanning Laser Systems Page 97 of 142 88293-EN, Rev C...
  • Page 98 Sample Posterior Advanced Info Treatment Report ® PASCAL Synthesis TwinStar Ophthalmic Scanning Laser Systems Page 98 of 142 88293-EN, Rev C...
  • Page 99 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 100: 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. 3.
  • Page 101 Intentionally left blank ® PASCAL Synthesis TwinStar Ophthalmic Scanning Laser Systems Page 101 of 142 88293-EN, Rev C...

  • Page 102: 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 103: 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 104: 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 105: System Specifications

    System Specifications [Specifications are subject to change without notice.] Treatment Beam 577 nm: OPSL Type 638 nm: Laser Diode Wavelength (nm) 577 & 638 577 nm: 0 - 2000 Power output (mW) 638 nm: 0 - 600 Duty cycle 100% Pulse durations (ms) 10-1000 Pulse interval...
  • Page 106 Electrical Requirements Voltage 100-240V~, 50/60Hz Rated power 200VA Fusing 200VA T2AH 250V Fan noise < 55 dBA Product Classifications per IEC 60601-1 Class I equipment Type B equipment Standard equipment, Footswitch is IPX1 Non-sterile product Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide Continuous operation Classifications &...
  • Page 107 Environmental Requirements (operating) 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 Environmental Requirements (non-operating) Maximum altitude Standard commercial shipping altitude Non-operating temperature -10°...

  • Page 108: 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.: 1.
  • Page 109 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 110 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 111 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 112: 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 113 Code Message Critical Clearable Warning Description Action Treatment Current Red 60µm Laser module draws Under for Red 60µm Call service if error persists. electric current below threshold. (Low) Treatment Current Red 60µm Laser module draws Over for Red 60µm Call service if error persists. electric current above threshold.
  • Page 114 Code Message Critical Clearable Warning Description Action Base Treatment Check fan and Temperature Low The base treatment temperature is ventilation. Allow system to (Severe) severely low cool. Base Treatment Check fan and The base treatment temperature is Temperature High ventilation. Allow system to high (Moderate) cool.
  • Page 115 Code Message Critical Clearable Warning Description Action Red Treatment Check fan and Laser module treatment Temperature Low ventilation. Allow system to temperature is low (Moderate) warm up. Red Treatment Check fan and Laser module treatment Temperature Low ventilation. Allow system to temperature is severely low (Severe) warm up.
  • Page 116 Code Message Critical Clearable Warning Description Action Ambient Temperature during Allow system to cool. Ambient Temperature treatment exceeds maximum Reconfigure treatment Over Maximum allowable value parameters if necessary User to select End Treatment and Return to the Home Screen. Aiming Local Light Aiming laser output is 100% over Re-access treatment screen Over (High)
  • Page 117 Code Message Critical Clearable Warning Description Action User to select End Treatment and Return to the Home Screen. Re-access treatment screen Red 60µm Treatment Laser output is 20% over the and reconfigure treatment Local Light Over (Low) expected value parameters. If error repeats-End Treatment and call Service User to select End...
  • Page 118 Code Message Critical Clearable Warning Description Action User to select End Treatment and Return to the Home Screen. Re-access treatment screen and Red 200µm Treatment Laser output is 100% over the reconfigure treatment Local Light Over expected value parameters. (High) If error repeats-End Treatment and call Service Unexpected local light...
  • Page 119 Code Message Critical Clearable Warning Description Action Reboot. Port 2 Fault An error was detected with port 2 Call service if error persists. Footswitch Defective Footswitch connected Verify footswitch connection. Discrepancy Main DSP Communication with the Main DSP Call service if error persists. Communication failed.
  • Page 120 Code Message Critical Clearable Warning Description Action Select a different favorite or The system cannot load the set parameters using the selected favorite because the Cannot Load Favorite: Touchscreen. favorite is not for the single-spot Not Single Spot pattern. Select a different favorite or The system cannot load the favorite set parameters using the because the 1-wire data is not...
  • Page 121 ® PASCAL Synthesis TwinStar Ophthalmic Scanning Laser Systems Page 121 of 142 88293-EN, Rev C...

  • Page 122: 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 123: 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 124: 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 125 CAUTION • Do not use the power strip in the patient environment. • Do not connect an additional power strip or an extension cord to the system. • Do not connect any device which is not recognized as a component of the system. •...

  • Page 126: 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. a) MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the ACCOMPANYING DOCUMENTS.
  • Page 127 Like other electrical medical devices, PASCAL Synthesis Ophthalmic Scanning Laser System require special precautions to ensure electromagnetic compatibility (EMC) with other electrical medical devices. To ensure EMC, your system must be installed and operated according to the EMC information provided in this manual. 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.
  • Page 128 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 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. Electromagnetic IEC 60601 Compliance...
  • Page 130 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. Electromagnetic environment IEC 60601-1-2:2014 Compliance...
  • Page 131 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 132: 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- 3.

  • Page 133: 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 134: Warranty Information

    Iridex Corporation. If it becomes necessary to return a product for repair and/or adjustments, authorization from Iridex Corporation must be obtained. Instructions as to how and where products should be shipped will be provided by Iridex Corporation. Any product or component returned for examination and/or warranty repair shall be sent insured and prepaid via the means of transportation specified by Iridex Corporation.

  • Page 135: 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.

  • Page 136: 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 137: 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 138: 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 TwinStar 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 139 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 140: 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 141: 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 142: Pslt 3 Row

    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.

Table of Contents