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Iridex Pascal 532 nm Operator's Manual

Ophthalmic scanning laser system
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Iridex Pascal
®
(532 nm / 577 nm)
Ophthalmic Scanning Laser System
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
Iridex Pascal System Software Rev 1.0.0
Caution: "Federal law restricts this device to sale by or on the order of a physician"

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  • Page 1 Ophthalmic Scanning Laser System Operator Manual Iridex Corporation 1212 Terra Bella Avenue Mountain View, CA 94043 Office: +1.650.940.4700 Fax: +1.650.962.0486 www.iridexretina.com Iridex Pascal System Software Rev 1.0.0 Caution: “Federal law restricts this device to sale by or on the order of a physician”...
  • Page 2 Iridex ® , the Iridex - Logo™ and PASCAL ® are trademarks or registered trademarks of Iridex Corporation. Iridex Pascal is trademarks of Iridex Corporation.

  • Page 3: Introduction

    Introduction Intended Use Iridex Pascal 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 4: Purpose Of This Manual

    Regulatory Information” sections to familiarize yourself with the operation of the system. Attention Iridex accepts full responsibility for safety, reliability and performance of the device only if: Service, readjustments, modifications and/or repairs are performed exclusively by Iridex • Corporation-certified personnel.

  • Page 5: Table Of Contents

    Safety Shutter ..........................20 Location of Controls ........................20 Manual Reset..........................20 Electrical Fault Detection Circuitry....................20 Location of Regulatory and Other System Labels ................. 21 Ophthalmic Applications ........................ 25 Iridex Pascal Page 5 of 112 ® DC-04076, Rev D...
  • Page 6 Connecting the System Components ....................39 Front Panel Connections ....................... 39 System Start-up and Shut-down ....................... 40 Starting the System ........................40 Shutting Down the System (Standard Shut-down) ................ 40 Iridex Pascal Page 6 of 112 ® DC-04076, Rev D...
  • Page 7 Favorite Window ..........................53 Edit Favorites Window ....................... 54 Center Panel ............................55 Controls ............................. 55 Power ............................. 55 Exposure ............................56 Spot Diameter Control ........................58 Spacing Field ..........................59 Iridex Pascal Page 7 of 112 ® DC-04076, Rev D...
  • Page 8 Enhanced Octant ........................... 77 MicroPulse Pattern Pallet ........................78 EPM Pattern Pallet ..........................79 Anterior Pallet ............................ 80 PSLT .............................. 80 Treatment Plan .......................... 80 Array .............................. 80 Single Spot ............................ 81 Iridex Pascal Page 8 of 112 ® DC-04076, Rev D...
  • Page 9 Ophthalmology References ................. 107 General information on Usage ................108 Intended Patient Population ......................108 Intended User Profile ........................108 Warranty Information .................... 109 Warranty Shipments, Returns, and Adjustments ................109 Iridex Pascal Page 9 of 112 ® DC-04076, Rev D...
  • Page 10 Disposal ......................... 110 Decontamination of Returned Equipment ..................111 Decontamination Certification ......................112 US Technical Service Information ................... 112 Iridex Pascal Page 10 of 112 ® DC-04076, Rev D...

  • Page 11: Cautions And Warnings

    Cautions and Warnings Disclaimer Calibration of the Iridex Pascal is a service procedure to be performed only by Iridex Corporation- certified personnel or customers who have taken and passed an 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 the...

  • Page 12: Ocular Protection

    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 13: Laser Safety Eyewear

    Europe and that comply with EN 207, the eyewear must have a protection class of L5 at 532 nm or L4 at 577 nm. Delivery Device NOHD (532 nm and 577 nm) Slit Lamp 5.4 m (17.7 feet) 16.1 m (52.8 feet) Iridex Pascal Page 13 of 112 ® DC-04076, Rev D...

  • Page 14: 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 15: Non-Homogeneous Pattern Delivery

    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. Iridex Pascal Page 15 of 112 ®...

  • Page 16: Titration

    Only the person aiming the laser beam should have access to the footswitch. Use caution depressing the footswitch when it is in proximity to a footswitch for other equipment. Make sure the footswitch depressed is the correct one to avoid accidental laser exposure. Iridex Pascal Page 16 of 112 ®...

  • Page 17: Operational Safety

    LIO has been checked to work properly by certified personnel. The video monitor must not be used to guide treatment or for diagnosis. The treating physician must visualize treatment through the slit lamp at all times. Iridex Pascal Page 17 of 112 ®...

  • Page 18: 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 19: Safety Compliance

    Caution: Federal law restricts this device to sale by or on the order of a physician. The Iridex PASCAL® (532 nm and 577 nm models) conform to the clauses of IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 identified in Section III of Laser Products – Conformance with IEC 60825-1 Ed.

  • Page 20: Laser Emission Indicator

    ON position. Electrical Fault Detection Circuitry If the electronic system detects a fault condition, laser exposure cannot occur. The laser is disabled, Iridex Pascal Page 20 of 112 ® DC-04076, Rev D...

  • Page 21: Location Of Regulatory And Other System Labels

    Location and description of caution, warning, and system labels are described on the following pages. On the side of the monitor Iridex Pascal Page 21 of 112 ® DC-04076, Rev D...
  • Page 22 Laser Radiation Caution Label, includes: Laser Emission Warning Iridex Pascal (577nm) Iridex Pascal (532 nm) Caution, Class 4 Laser Emission Laser beam may be present in this area, when opened. Laser Aperture Label Laser Emission Warning Iridex Pascal Page 22 of 112 ®...
  • Page 23 Laser Emission Warning • • Wavelength • Power Laser Class • Iridex Pascal (577nm) Iridex Pascal (532 nm) Hospital Grade Cord Grounding Instructions USB Connections Remote Door Interlock Connection Footswitch Connection Iridex Pascal Page 23 of 112 ® DC-04076, Rev D...
  • Page 24 Type B applied part λ Wavelength (nm) Rx ONLY Prescription Only TÜV Rhineland Test Mark Footswitch Ingress Protection IPX 8 Suitable for continuous immersion water Caution CE mark with BSI Netherlands NB Number Iridex Pascal Page 24 of 112 ® DC-04076, Rev D...

  • Page 25: Ophthalmic Applications

    Ophthalmic Applications Iridex Pascal 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. Iridex Pascal 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 26: Potential Complications Or Side Effects

    Sneezing and coughing should be controlled with cough syrup or other medications. Immediately following treatment, patients should avoid altitudes over 2500 m (~8000 ft.). Iridex Pascal Page 26 of 112 ®...

  • Page 27: Anterior Segment Laser Procedures

    Transient corneal epithelial burns have reportedly been resolved within 1 week without scarring. Endothelial burns are rarely encountered when careful focusing is employed. Rarely, severe iritis may occur, related to either an unusual patient response or improper spot location. Iridex Pascal Page 27 of 112 ®...

  • Page 28: System Components

    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. Iridex Pascal Page 28 of 112 ® DC-04076, Rev D...

  • Page 29: Slit Lamp (Model Sl-Pa05)

    Slit Lamp (model SL-PA05) Integrated slit lamp connection. Service personnel will connect the laser system to the slit lamp. Iridex Pascal Slit Lamp PA05 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.

  • Page 30: Footswitch

    Breath Shield Fits onto the slit lamp and provides a first line of defense for both healthcare providers and patients. Safety Glasses Provides eye protection while worn in the treatment room. Iridex Pascal Page 30 of 112 ® DC-04076, Rev D...

  • Page 31: Elbow Pad

    Power Cord Laser Warning Sign LIO (Laser Indirect Ophthalmoscope) – Optional Accessory The LIO is an optional accessory to the Iridex Pascal system. Refer to the LIO Operator Manual for detailed safety and regulatory compliance information. Wireless Footswitch – Optional Accessory...

  • Page 32: Micropulse (Software Option)

    MicroPulse exposures, subvisible treatments often call for the administration of a greater number of treatment spots with denser spacing than that used for threshold laser grid treatments. Iridex Pascal Page 32 of 112 ®...

  • Page 33: References

    Pattern Scanning Laser Trabeculoplasty (PSLT) (Software Option) Indications for Use Pattern Scanning Laser Trabeculoplasty (PSLT) software is intended for use with the Iridex Pascal 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 34 If, during the course of the treatment, the footswitch is released before the entire pattern is delivered, “Treatment Complete” and “<NN Incomplete Segments>” (where “<NN>” represents the number of segments that were not completed) display in the PSLT Treatment summary window. Iridex Pascal Page 34 of 112 ® DC-04076, Rev D...

  • Page 35: System Specifications

    System Specifications [Specifications are subject to change without notice.] Treatment Beam Iridex Pascal (532 nm) Iridex Pascal (577 nm) Type Optically Pumped Semiconductor Laser (OPSL) Wavelength (nm) Power output (mW) 0 – 2000 Power increments • 10 mW (from 30 mW to 150 mW, omitting 10 mW and 20 mW) 25 mW (from 150 mW to 2000 mW) •...
  • Page 36 Electrical Requirements Iridex Pascal (532 nm) Iridex Pascal (577 nm) Voltage 100-240V~, 50/60Hz Rated power 600VA Fusing 218 Series, 5×20 mm, Time-Lag Fuse Fan noise < 55 dBA Product Classifications per IEC 60601-1 Class I equipment Type B equipment Standard equipment, Footswitch is IPX8...

  • Page 37: Physical Characteristics

    Environmental Requirements (operating) Iridex Pascal (532 nm) Iridex Pascal (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 38: System Installation And Setup

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

  • Page 39: Connecting The System Components

    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 Iridex Pascal System. Iridex Pascal Page 39 of 112 ®...

  • Page 40: System Start-Up And Shut-Down

    If the system becomes unresponsive during laser emission, press the emergency laser stop button on the front of the console. Turn the key switch to the OFF position. Before restarting, press the emergency laser stop button to disengage it. Iridex Pascal Page 40 of 112 ®...

  • Page 41: Home Screen

    Select to go to the system software version dialog. After selecting the Treatment, the system will display a message at the center of the Treatment screen during system warm up. Iridex Pascal Page 41 of 112 ® DC-04076, Rev D...

  • Page 42: System Setup Screen

    Enable the EPM feature in Single and Pattern Group. Progressive Titrate Enable/Disable Progressive titrate. System Volume Slide the bar left or right to adjust system volume. Fire Volume Slide the bar left or right to adjust fire volume. Iridex Pascal Page 42 of 112 ® DC-04076, Rev D...

  • Page 43: Patient Information Feature

    The information you entered in the Patient information window is displayed on the Treatment screen and in the Treatment Report. NOTE The operating system does not save this information when you select End Treatment. Iridex Pascal Page 43 of 112 ® DC-04076, Rev D...

  • Page 44: Counter Reset

    If a lens is selected, selecting will change the output in Treatment Time When treatment time is enabled, the treatment duration is visible on the Treatment screen and in the reports. Iridex Pascal Page 44 of 112 ® DC-04076, Rev D...

  • Page 45: Surgical Timeout

    Advanced EPM Mode Display When Advanced EPM Mode Display is enabled and has EPM Software license, EPM will be available for single and pattern group, in addition to EPM pattern group. Iridex Pascal Page 45 of 112 ® DC-04076, Rev D...

  • Page 46: Progressive Titrate

    When one of the reports is selected under Posterior/Anterior report, the Treatment Report window displays when you select the End Treatment button at the completion of each patient treatment session. Iridex Pascal Page 46 of 112 ® DC-04076, Rev D...

  • Page 47: Procedure To Prepare The Usb Drive Before The First Time Use

    All the reports exported from Iridex Pascal will be stored in the ‘synthesis_report’ folder in the USB drive. You can plug the USB drive into a PC to copy or delete the exported reports.

  • Page 48: Posterior Reports

    Posterior Reports Select the report setting from the following: None, Basic, or Advanced Sample Posterior Basic Treatment Report Sample Posterior Advanced Treatment Report Iridex Pascal Page 48 of 112 ® DC-04076, Rev D...

  • Page 49: Anterior Reports

    Aux setting to enable Aux None Aux off all the time Lid up Aux when changed from STANDBY to Ready READY mode. Lid up Aux when changed from STANDBY to Treat TREAT. Iridex Pascal Page 49 of 112 ® DC-04076, Rev D...

  • Page 50: Time Format

    Select the date format for the date of birth and treatment date on the report, and date of birth on the Surgical Timeout confirmation screen. Additional Features Enter Iridex Pascal License Code to enable the license key of MicroPuse/EPM/PSLT. Lens Tab Posterior/Anterior Lenses Each type of treatment consists of a List box that displays the Contact List.
  • Page 51 Displays settings to remind the user to set ocular power before treatment. Advance Direction Select direction for the Auto Advance feature. Auto-Transition after Will advance to pattern after Enhanced Octant is completed (available Enhanced Octants when Endpoint Management is activated). Iridex Pascal Page 51 of 112 ® DC-04076, Rev D...

  • Page 52: Auto-Transition Feature

    EpM Enhanced Octants and to STANDBY mode. In the case of Array pattern selected In the case of Hexagon pattern selected Auto-Transition After Enhanced Octants Treatment Screen Top Panel Iridex Pascal Page 52 of 112 ® DC-04076, Rev D...

  • Page 53: Favorite Window

    1 second in the Favorite list. To close the pop-up, touch the pop- up or anywhere on the screen. If the favorite is pressed and released shorter than 1 second, the favorite will be loaded. Iridex Pascal Page 53 of 112 ®...

  • Page 54: Edit Favorites Window

    Rename Select to change the name of the selected favorite. Remove Select to remove the selected favorite from Favorites window. Save Select to save the edit for the selected favorite. Iridex Pascal Page 54 of 112 ® DC-04076, Rev D...

  • Page 55: Center Panel

    4. Drag the list to the location you want to move to. Center Panel Controls Power Description Up/Down arrow button to adjust Power, or turn the Power Knob on the slit lamp. Iridex Pascal Page 55 of 112 ® DC-04076, Rev D...

  • Page 56: Exposure

    Exposure Range: 15 ms - 30 ms Line (20 ms) Exposure Range: 10 ms - 15 ms Octant (10 ms) Exposure Range: 10 ms - 15 ms Enhanced Octant (10 ms) Iridex Pascal Page 56 of 112 ® DC-04076, Rev D...
  • Page 57 If n <= 3 and m <= 3 Max: 80 ms, If n > 3 or m > 3 Max: 30 ms Exposure Range: 10 ms - 1000 ms Exposure Max: 10 ms - 1000 ms Single Spot (10 ms) Iridex Pascal Page 57 of 112 ® DC-04076, Rev D...

  • Page 58: Spot Diameter Control

    Y (Default) Enhanced Octant The same as Pattern Pallet MicroPulse Enhanced Octant Y (Default) Y (Default) Array 2x2 Y (Default) Array 3x3, 4x4 Y (Default) Hexagon Y (Default) Single Spot Iridex Pascal Page 58 of 112 ® DC-04076, Rev D...

  • Page 59: Spacing Field

    0.00Φ - 0.50Φ Radius: 500µm - 600µm Spacing Range: 0.25Φ - 0.50Φ 300 µm Radius: 700µm Spacing Range: 0.50Φ Radius: 800µm - 1000µm Spot Pattern Pallet Arc Range Diameter (Default: 0.50Φ) Iridex Pascal Page 59 of 112 ® DC-04076, Rev D...
  • Page 60 Inner Radius Range: Radius: Spacing Range: 0.00Φ - 3.00Φ 500 µm - 1700 µm 100 µm 2200 µm Spacing Range: 0.00Φ - 2.00Φ 500 µm - 1800 µm 2200 µm Iridex Pascal Page 60 of 112 ® DC-04076, Rev D...

  • Page 61: Endpoint Management

    2x2, 3x3 Spacing Range: 0.00Φ - 1.50Φ 300 µm 2x2, 3x3 Endpoint Management Description Select EpM to change the value of percentage range Range Range Pattern (Default) 10% to 95%. Iridex Pascal Page 61 of 112 ® DC-04076, Rev D...

  • Page 62: Micropulse

    500 µm - 2000 µm 300 µm Spacing: 0.00Φ - 0.50 Φ Pattern Pallet Octant (Default Radius: 1100 µm) Radius Range: 1100 µm - 1600 µm 100 µm Spacing: 0.25Φ Iridex Pascal Page 62 of 112 ® DC-04076, Rev D...
  • Page 63 Inner Radius Range: 500 µm - 1700 µm Set Outer Radius Spacing: 0.25Φ-0.50Φ Outer Radius Max: 2200 µm to 2200 µm Inner Radius Range: 500 µm - 1600 µm Spacing: 1.00Φ Outer Radius Max: 2200 µm Iridex Pascal Page 63 of 112 ® DC-04076, Rev D...

  • Page 64: Curvature Field

    4.0Hz – Max Exposure is 200 ms 5.0Hz – Max Exposure is 150 ms 6.0Hz – Max Exposure is 100 ms 7.0Hz – Max Exposure is 100 ms 8.0Hz – Max Exposure is 100 ms Iridex Pascal Page 64 of 112 ® DC-04076, Rev D...
  • Page 65 4.0Hz – Max Exposure is 200 ms 5.0Hz – Max Exposure is 150 ms 6.0Hz – Max Exposure is 100 ms 7.0Hz – Max Exposure is 100 ms 8.0Hz – Max Exposure is 100 ms Iridex Pascal Page 65 of 112 ® DC-04076, Rev D...

  • Page 66: Treatment Plan Field

    Titration burns should only be delivered outside the visual field to the outer retina. It is recommended that the physician wait at least 3 seconds before evaluating the titration lesions because this is the time it takes to achieve the maximum response. Iridex Pascal Page 66 of 112 ®...
  • Page 67 Single spot at center of pattern Wedge 6x6 Single spot at center of pattern Single spot at 12 o’clock of selected ring Inner Arc Single spot at center of selected arc Iridex Pascal Page 67 of 112 ® DC-04076, Rev D...

  • Page 68: Internal Fixation Light

    The fixation beam does not apply to the treatment laser pattern. Outline Description Select to enable full pattern outline (when applicable). Display the entire area where the laser irradiation is planned Iridex Pascal Page 68 of 112 ® DC-04076, Rev D...

  • Page 69: Auto Advance Feature

    The selected pattern is delivered when you press the footswitch, after which the system automatically advances to the next pattern. The orientation is selectable as clockwise or counter-clockwise in Physician Preferences. System Automatically Advances to Next Pattern Iridex Pascal Page 69 of 112 ® DC-04076, Rev D...

  • Page 70: Auto-Transition Feature

    Select to turn on/off aiming beam in STANDBY (always on in READY). Aiming beam intensity: scroll up/down to adjust. Move the white bar to adjust Aim intensity. Center Description Select to position the beam to optical center of the treatment. Iridex Pascal Page 70 of 112 ® DC-04076, Rev D...

  • Page 71: Rotation

    In that case, the setting will be reset to the default. • The full range of settings is not available for every combination of parameters. Iridex Pascal Page 71 of 112 ® DC-04076, Rev D...

  • Page 72: Single Pallet

    PRP, retina tears, retina detachments, iridotomy, trabeculoplasty, LIO • The Single Spot pattern can be used with the slit lamp or an optional laser indirect ophthalmoscope (LIO). Spot diameter and repetition rate settings are adjustable. Iridex Pascal Page 72 of 112 ® DC-04076, Rev D...

  • Page 73: Pattern Pallet

    The tickmarks are positioned at 15 degree intervals, from 0 to 345 degrees. NOTE The selection of spacing will differ depending on the slit lamp used. Iridex Pascal Page 73 of 112 ® DC-04076, Rev D...

  • Page 74: Triple Arc

    To select the pattern orientation, select one of the tickmarks on the rotation guide that displays in the pattern background. The tickmarks are positioned at 15 degree intervals, from 0 to 345 degrees. Iridex Pascal Page 74 of 112 ®...

  • Page 75: Arc

    PRP, retina tears, retina detachments • The Triple Ring pattern is fixed, but the spot diameter, spacing, and radius settings are adjustable. The entire pattern is delivered when you press the footswitch. Iridex Pascal Page 75 of 112 ® DC-04076, Rev D...

  • Page 76: Line

    The full range of settings is not available for every combination of parameters. • Do not allow to swipe to single spot for line patterns. If needed, please select the single spot pattern. Iridex Pascal Page 76 of 112 ® DC-04076, Rev D...

  • Page 77: Octant

    The selection of inner radius and outer radius will differ depending on the slit lamp used. • The full range of settings is not available for every combination of parameters. Iridex Pascal Page 77 of 112 ® DC-04076, Rev D...

  • Page 78: Micropulse Pattern Pallet

    When auto-advanced mode is not enabled, the treated segment spots will also be marked as hollow for enhanced octant pattern. MicroPulse Pattern Pallet Same pattern selection available as Pattern Pallet in yellow dots. Iridex Pascal Page 78 of 112 ® DC-04076, Rev D...

  • Page 79: Epm Pattern Pallet

    Power and Exposure settings keep the same as the previous selected EpM pattern. • Endpoint and Landmark patterns only available in Single Spot, Array, Hexagon, Triple Arc, Wedge, Line and Octants pattern pallets when titration is off. Iridex Pascal Page 79 of 112 ® DC-04076, Rev D...

  • Page 80: Anterior Pallet

    The PSLT pattern is selectable in various orientations. To select the pattern orientation, select the Rotate button at the bottom of the screen. The pattern spacing is fixed, but curvature is adjustable. Treatment Plan 180-degree 360-degree Array Primary Pattern Secondary Pattern Iridex Pascal Page 80 of 112 ® DC-04076, Rev D...

  • Page 81: Single Spot

    The Endpoint Management feature is not available in the Anterior Treatment.  • PSLT is available only for 532 and 577 nm. Single Spot Primary Pattern Secondary Pattern Not available General Use • Retina tears and retina detachments Iridex Pascal Page 81 of 112 ® DC-04076, Rev D...

  • Page 82: Intraoperative Instructions

    STANDBY mode, and the touchscreen control panel becomes light gray. To resume activity, touch the screen. The Status control displays “START UP” for approximately 90 seconds until the system is ready again. Iridex Pascal Page 82 of 112 ®...

  • Page 83: Lio Treatment Procedure

    System”. 2. Remove the key to prevent unauthorized use of the system. 3. Clean the system as described in “User Maintenance”. 4. Place a dust cover over the slit lamp. Iridex Pascal Page 83 of 112 ® DC-04076, Rev D...

  • Page 84: Maintenance Instructions

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

  • Page 85: Replacing The Fuses

    5. Verify that the footswitch cable is securely connected. 6. Verify that the LCD control panel cables are correctly installed. 7. Verify that the emergency laser stop button is not depressed. Iridex Pascal Page 85 of 112 ® DC-04076, Rev D...

  • Page 86: System Does Not Turn On

    Monitor/touchscreen panel power, USB and signal cables are not correctly connected. Suggestion: Ensure that the monitor cables are correctly connected. Trouble Adding/Removing Favorites Probable Cause: Favorite’s Database Update Error. Suggestion: Reboot the System. Iridex Pascal Page 86 of 112 ® DC-04076, Rev D...

  • Page 87: 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

    Ensure that the action that activated remote interlock has ceased and proceed. Probable Cause: Footswitch and/or footswitch cable damaged. Suggestion: Inspect for damage. Probable Cause: Internal system error. Suggestion: Contact Pascal Technical Service. Iridex Pascal Page 87 of 112 ® DC-04076, Rev D...

  • Page 88: Error Messages

    Verify device connections. Treatment Current when it was not expected Treatment Current Red 60µm Laser module draws Under for Red 60µm Call service if error persists. electric current below threshold. (Low) Iridex Pascal Page 88 of 112 ® DC-04076, Rev D...
  • Page 89 Call service if error persists. (High) electric current above threshold. Unexpected Electric current was drawn by the Treatment Current for Red 200µm Laser module when it Verify device connections. Red 200µm was not expected Iridex Pascal Page 89 of 112 ® DC-04076, Rev D...
  • Page 90 Laser module treatment Temperature High temperature is severely high (Severe) Check fan and ventilation. Allow system to LBO Treatment warm up. Laser module treatment Temperature Low temperature is low (Moderate) Iridex Pascal Page 90 of 112 ® DC-04076, Rev D...
  • Page 91 The ambient temperature is high Reconfigure treatment High (Moderate) parameters if necessary Allow system to cool. Ambient Temperature The ambient temperature is Reconfigure treatment High (Severe) severely high parameters if necessary Iridex Pascal Page 91 of 112 ® DC-04076, Rev D...
  • Page 92 Home Screen. OPSL Treatment Re-access treatment screen Laser output is 20% under the Local Light Under and reconfigure treatment expected value (Low) parameters. If error repeats-End Treatment and call Service Iridex Pascal Page 92 of 112 ® DC-04076, Rev D...
  • Page 93 Home Screen. Re-access treatment screen Laser output is 20% over the and reconfigure treatment expected value parameters. Red 60µm Treatment If error repeats-End Local Light Over (Low) Treatment and call Service Iridex Pascal Page 93 of 112 ® DC-04076, Rev D...
  • Page 94 Home Screen. Laser output is 50% over the Re-access treatment screen expected value and reconfigure treatment parameters. Red 200µm Treatment If error repeats-End Local Light Over Treatment and call Service (Medium) Iridex Pascal Page 94 of 112 ® DC-04076, Rev D...
  • Page 95 An error occurred within the spot Spot Size Service F- Clear error to continue size service regarding the F galvo Galvo Call service if error persists. Iridex Pascal Page 95 of 112 ® DC-04076, Rev D...
  • Page 96 The pattern cannot be modified at Press Ready button on this time. Certain patterns can only Touchscreen to return to Pattern Locked be modified in Standby mode. Standby mode before modifying patterns. Iridex Pascal Page 96 of 112 ® DC-04076, Rev D...
  • Page 97 Call service if error persists. Invalid Attachment The calibration file is missing, not Reboot. Calibration readable, or incomplete. Check the Call service if error persists. log file for the exact problem. Iridex Pascal Page 97 of 112 ® DC-04076, Rev D...
  • Page 98 Call service if error persists. Invalid 3D Controller An invalid 3D controller is Power off the system, disconnect the invalid 3D connected. controller from the system and then power on the system. Iridex Pascal Page 98 of 112 ® DC-04076, Rev D...

  • Page 99: Calibration Procedure

    Disclaimer Warning Calibration of the system is a service procedure to be performed only by certified Iridex personnel. Adjustment by anyone other than certified Iridex personnel voids any existing manufacturer’s warranty on the instrument and can result in serious personal injury.

  • Page 100: System Relocation Instructions

    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. Iridex Pascal Page 100 of 112 ®...

  • Page 101: 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. • Use the insulation transformer conforming to IEC 60601-1. Iridex Pascal Page 101 of 112 ® DC-04076, Rev D...

  • Page 102: Electromagnetic Compatibility

    Electromagnetic Compatibility Applicable to Iridex Pascal with serial numbers starting with “90” (e.g., 90xxxxxx). This product conforms to the EMC standard (IEC 60601-1-2: 2020). 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 103 Guidance and manufacturer's declaration - electromagnetic emissions The Iridex Pascal is intended for use in the electromagnetic environment specified below. The customer or the user of the Iridex Pascal should assure that it is used in such an environment. Emissions test...

  • Page 104: Electromagnetic Environment - Guidance

    Guidance and manufacturer's declaration - electromagnetic immunity The Iridex Pascal is intended for use in the electromagnetic environment specified below. The customer or the user of the Iridex Pascal should assure that it is used in such an environment. Immunity test...
  • Page 105 Guidance and manufacturer's declaration - electromagnetic immunity The Iridex Pascal is intended for use in the electromagnetic environment specified below. The customer or the user of the Iridex Pascal should assure that it is used in such an environment. Immunity test...
  • Page 106 DECT 217Hz 1970 LTE Band 1,3,4,25 UMTS Bluetooth WLAN Pulse 802.11 2450 2400-2570 modulation b/g/n 217Hz RFID 2450 LTE Band7 5240 Pulse WLAN 5500 5100-5800 modulation 802.11 a/n 217Hz 5785 Iridex Pascal Page 106 of 112 ® DC-04076, Rev D...

  • Page 107: Ophthalmology References

    Thomas JV, Simmons R and Belcher CD III. Complications of Krypton Laser Trabeculoplasty Glaucoma 4:50, 1982 Wise JB, Errors in Laser Spot Size in Laser Trabeculoplasty Ophthalmology, 91:186, 1984 Kanski JJ, Clinical Ophthalmology, Second Edition. Butterworths, 1989 Iridex Pascal Page 107 of 112 ® DC-04076, Rev D...

  • Page 108: General Information On Usage

    Fix the face to the chinrest, forehead rest. • Keep the eye open. • Understand and follow the instructions when undergoing a treatment. Intended User Profile This device must be used by a physician only. Iridex Pascal Page 108 of 112 ® DC-04076, Rev D...

  • Page 109: Warranty Information

    Iridex Corporation warrants Iridex Pascal to be free from defects in material and workmanship at the original purchaser's location for 12 months. In order to comply with this warranty, all internal adjustments or modifications must be made by Iridex Corporation-certified personnel or with the express permission of the Iridex Corporation Service Department.

  • Page 110: 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. NOTE EU Battery Directive This symbol is applicable for EU members states only.

  • Page 111: 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 112: Decontamination Certification

    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. ☐ 532 nm ☐ 577 nm...

This manual is also suitable for:

Pascal 577 nm

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