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Iridex 577 Operator's Manual

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Iridex
577
Laser System
Operator Manual

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Summary of Contents for Iridex 577

  • Page 1 ® Iridex Laser System Operator Manual...
  • Page 2 24001-EN Rev C 09.2024 © 2024 by Iridex Corporation. All rights reserved. Iridex, the Iridex logo, Iridex 532, Iridex 577, MicroPulse, EndoProbe, and TxCell are registered trademarks; CW-Pulse, OtoProbe, and TruFocus are trademarks of Iridex Corporation. All other trademarks are the property of their respective holders.

  • Page 3: Table Of Contents

    Potential Side Effects or Complications ..................5 Specific Warnings and Precautions ................... 5 Laser Settings ..........................6 577 nm Typical Laser Treatment Parameters for Ocular Photocoagulation ......6 Warnings and Cautions ........................8 Iridex Corporation Contact Information .................... 9 CONSOLE SETUP ..................... 10 Unpack the System ........................
  • Page 4 Cleaning and Inspecting the Laser System ................... 54 Cleaning the Laser Console ....................54 Cleaning the Touchscreen ...................... 54 Cleaning the Footswitch ......................54 Inspecting the Laser System ....................54 ® Iridex 577 Laser System Operator Manual 24001-EN Rev C...
  • Page 5 Guidance and Manufacture’s Declaration – Electromagnetic Emission ........77 Guidance and Manufacture’s Declaration – Electromagnetic Immunity ........77 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the Laser ......................79 ® 24001-EN Rev C Iridex 577 Laser System Operator Manual...

  • Page 7: Introduction

    Follow the instructions for use described in this operator manual. Pulse Types ® The Iridex 577 Laser can deliver a CW laser pulse in 2 modes: CW-Pulse™ mode and MicroPulse mode. CW-Pulse Laser emission is continuous during the entire timed exposure.

  • Page 8: References

    MicroPulse laser treatment can be performed using 532 nm, 577 nm, or 810 nm wavelengths. Studies have confirmed that 577 nm and 810 nm subvisible laser treatment can be clinically effective while inducing no tissue changes discernible by slit lamp observation, fluorescein angiography, fundus autofluorescence, or at any time postoperatively.
  • Page 9 4. Lavinsky D, Cardillo JA, Melo LA, Jr., Dare A, Farah ME, Belfort R, Jr. Randomized clinical trial evaluating mETDRS versus normal or high-density micropulse photocoagulation for diabetic macular edema. Invest Ophthalmol Vis Sci 2011 52(7):4314-23. ® 24001-EN Rev C Iridex 577 Laser System Operator Manual...

  • Page 10: Compatible Iridex 577 Delivery Devices

    Compatible Iridex 577 Delivery Devices IMPORTANT! The Iridex 577 Laser may be used with compatible Iridex delivery devices that have either resistive or RFID connectors. NOTE: Before using a compatible delivery device, refer to the Operator Manual and/or Instructions for...

  • Page 11: Indications For Use

    Indications for Use The Iridex ® 577 Laser Console is a solid-state laser that is used to deliver laser energy in either continuous-wave pulse (CW-pulse) or MicroPulse ® mode, for ophthalmic applications. Ophthalmology Indicated for use in photocoagulation of both anterior and posterior segments, including: •...

  • Page 12: Laser Settings

    If uncertain of expected clinical response, always start with a conservative setting and increase the setting in small steps. 577 nm Typical Laser Treatment Parameters for Ocular Photocoagulation 577 nm Continuous-Wave...
  • Page 13 577 nm MicroPulse Spot Size Exposure Delivery Power Duty Cycle Application at Target* Duration Device (mW) (500 Hz) (µm) (ms) Trabeculoplasty 200–300 400–1200 5%, 10%, 15% 100–300 *Spot size at target is dependent on many parameters, including spot size selection, physician’s choice of laser delivery lens, and patient’s refractive power.

  • Page 14: Warnings And Cautions

    Do not operate the equipment in the presence of flammables or explosives, such as volatile anesthetics, alcohol, and surgical preparation solutions. Laser plume may contain viable tissue particulates. Keep the protective cap over the fiber-optic connector when the delivery device is not in use. ® Iridex 577 Laser System Operator Manual 24001-EN Rev C...

  • Page 15: Iridex Corporation Contact Information

    Remedy, and Limitation of Liability contained in Iridex’s Terms and Conditions. WARNING: Use only Iridex delivery devices with the Iridex laser system. Use of a non-Iridex delivery device may result in unreliable operation or inaccurate delivery of laser power. This Warranty and Service agreement does not cover damage or defect caused by the use of non-Iridex devices.

  • Page 16: Console Setup

    2. Console Setup Unpack the System Make sure you have all components that were ordered. Check all components for damage before use. NOTE: Contact Iridex Customer Service if there are problems with your order. ® Iridex 577 Laser Console Remote Interlock Connector...

  • Page 17: Choose A Location

    Do not defeat the purpose of the grounding pin. This equipment is intended to be electrically grounded. Contact a licensed electrician if your outlet prevents you from inserting the plug. Do not position or use the system near open flames. ® 24001-EN Rev C Iridex 577 Laser System Operator Manual...

  • Page 18: Connect The Components

    The Multipurpose port is also used to connect the TxCell scanner control box to the laser console. If the TxCell scanner is used with an optional Iridex wired or wireless footswitch, connect the TxCell serial cable into the laser console multipurpose port and connect the footswitch into one of the two serial ports on the rear panel of the TxCell control box.

  • Page 19: Inserting Connectors

    Insert the standard footswitch and interlock connectors with the red dot facing upwards. Removing Connectors Remove the standard footswitch and interlock connectors by pulling the connector straight out. Do not twist the connector. ® 24001-EN Rev C Iridex 577 Laser System Operator Manual...

  • Page 20: Set Date And Time

    6. To return to the S ETTINGS SCREEN • Select System Options in the upper-left corner. • From the S , select Settings in the upper-left corner. YSTEM PTIONS SCREEN ® Iridex 577 Laser System Operator Manual 24001-EN Rev C...

  • Page 21: Console Controls

    External illumination connector port. Emergency laser stop. See “Emergency Laser Stop”. Smart Key. Used with a slit lamp adapter delivery device. Communicates the spot size and safety filter information to the Iridex laser console. Fiber port. See “Fiber Port”. ®...

  • Page 22: Color Touchscreen

    Verify that all persons in the treatment room are wearing the appropriate laser safety eyewear before placing the laser in Treat mode. Never substitute prescription eyewear for laser safety eyewear. ® Iridex 577 Laser System Operator Manual 24001-EN Rev C...

  • Page 23: Control Knob

    After a field is activated, turn the control knob to adjust the value (clockwise to increase the value; counter-clockwise to decrease the value). • Press the control knob to deselect or deactivate a field. ® 24001-EN Rev C Iridex 577 Laser System Operator Manual...

  • Page 24: Emergency Laser Stop

    Press the Emergency Laser Stop button to terminate laser emission. Fiber Port The fiber port accepts resistive and Iridex RFID delivery devices. Warning: Do not remove the fiber during the use of the device. The fiber cannot be sharply bent. The bend radius must be more than 15 cm (6 in.).

  • Page 25: System Settings Screens

    BOUT SCREEN TxCell Scanner (appears only when TxCell is connected to the laser console). Select the icon to access the T PTIONS SCREEN Service. Password-protected and accessible only by Iridex Technical Support. ® 24001-EN Rev C Iridex 577 Laser System Operator Manual...

  • Page 26: Presets Screen Without Delivery Device Connected

    Physician. This field is blank upon first system use. When this field is populated, use the pop-up keyboard to select a physician or enter a new physician name. ® Iridex 577 Laser System Operator Manual 24001-EN Rev C...

  • Page 27: Presets Screen With Delivery Device Connected

    Add New Preset. Select to access the A RESET SCREEN Delete Preset. To delete a preset, highlight the preset and then select the trash can icon. ® 24001-EN Rev C Iridex 577 Laser System Operator Manual...

  • Page 28: Add Preset Screen

    Power. Use the control knob or touchscreen to select and activate the field; use the control knob to adjust Power in mW. • Interval. Use the control knob or touchscreen to select and activate the field; use the control knob to adjust Interval in ms. ® Iridex 577 Laser System Operator Manual 24001-EN Rev C...

  • Page 29: Edit Preset Screen

    Interval. Use the control knob or touchscreen to select and activate the field; use the control knob to adjust Interval in ms. Cancel. Select to cancel changes and return to the P RESETS SCREEN ® 24001-EN Rev C Iridex 577 Laser System Operator Manual...

  • Page 30: Treatment Mode Screen

    Reset to Defaults. Select to reset the parameters to their default values (5% Duty Cycle). Cancel. Select to cancel changes and return to the S ETTINGS CREEN ® Iridex 577 Laser System Operator Manual 24001-EN Rev C...

  • Page 31: System Options Screen

    Operational Parameters. Select the icon to access the O PERATIONAL ARAMETERS SCREEN Audio. Select the icon to access the A UDIO SCREEN Date and Time. Select the icon to access the D ATE AND IME SCREEN ® 24001-EN Rev C Iridex 577 Laser System Operator Manual...

  • Page 32: Aiming Beam Screen

    Treating. Select On, Off, or Blink. Ready to Treat. View only. Aiming beam is always On during Ready to Treat. Cancel. Select to cancel changes and return to the S YSTEM PTIONS SCREEN ® Iridex 577 Laser System Operator Manual 24001-EN Rev C...

  • Page 33: Operational Parameters Screen

    Display Total Energy. Select On or Off. When On, Total Energy displays on the S TANDBY , and T screens. EADY TO REAT REATING Cancel. Select to cancel changes and return to the S YSTEM PTIONS SCREEN ® 24001-EN Rev C Iridex 577 Laser System Operator Manual...

  • Page 34: Audio Screen

    Voice Prompt. Treatment Mode: Select Male, Female, or Off. Voice Prompt. Laser Ready: Select Male, Female, or Off. Cancel. Select to cancel changes and return to the S YSTEM PTIONS SCREEN ® Iridex 577 Laser System Operator Manual 24001-EN Rev C...

  • Page 35: Date And Time Screen

    Report Time Format. Select the desired time format for treatment reports, 12 hour or 24 hour. Cancel. Select to cancel changes and return to the S YSTEM PTIONS SCREEN ® 24001-EN Rev C Iridex 577 Laser System Operator Manual...

  • Page 36: Treatment Reports Screen

    Delete. Select to delete the selected report. This icon is greyed out if no report is selected. Deleting a report is permanent. After it is deleted, the report is no longer available. NOTE: You cannot delete the report for the current treatment. ® Iridex 577 Laser System Operator Manual 24001-EN Rev C...

  • Page 37: Exporting Treatment Reports (Optional)

    Exporting Treatment Reports (Optional) The Export Report icons, as shown below, represent whether the Exporting Treatment Reports option has been enabled in the Iridex 577 laser. Exporting Treatment Exporting Treatment Reports feature enabled Reports feature disabled Only one report can be selected at a time to export to a USB. The file name of each exported treatment report will be labeled with the date and time of export and will not overwrite other files already in the USB drive.

  • Page 38: Treatment Report Example

    3. When you are finished, select Done. 4. The Export Complete pop-up message displays. Select Okay and remove the USB drive. Treatment Report Example ® Iridex 577 Laser System Operator Manual 24001-EN Rev C...

  • Page 39: About Screen

    About Screen Displays laser console hardware information, software information, and Iridex Technical Support contact information. Screen Navigation, Left Arrow. Select to return to the S ETTINGS CREEN ® 24001-EN Rev C Iridex 577 Laser System Operator Manual...

  • Page 40: User Interface Screens

    5. User Interface Screens Idle Screen This screen appears automatically only if no delivery device is connected. . Select to go to the S ETTINGS ETTINGS CREEN ® Iridex 577 Laser System Operator Manual 24001-EN Rev C...

  • Page 41: Standby Screen

    Aiming Beam Adjustment. Select and activate the field and use the control knob to adjust the aiming beam illumination from 1 (dimmest) to 20 (brightest). Favorites. Select to create and name a new preset based on the treatment parameters displayed on this screen. ® 24001-EN Rev C Iridex 577 Laser System Operator Manual...
  • Page 42 Power in mW. • Interval. Use the control knob or touchscreen to select and activate the field, and the control knob to adjust Interval in ms, or turn to select single shot. ® Iridex 577 Laser System Operator Manual 24001-EN Rev C...

  • Page 43: Power Selection Warning Messages

    Power Selection Warning Messages Zero Power Screen Navigation, Left Arrow. Select to return to the S TANDBY SCREEN Screen Navigation, Right Arrow. Select Treat to continue to the R EADY REAT SCREEN ® 24001-EN Rev C Iridex 577 Laser System Operator Manual...

  • Page 44: Standard Slit Lamp Adapter And Txcell (Single-Spot Delivery) Standby Screen

    “Single Shot”, or continue to turn the knob counterclockwise to select a grid pattern: “Grid”, “Circle”, or “Triple Arc”. To change the parameters of a selected pattern, press the control knob to go to the Pattern Editor. ® Iridex 577 Laser System Operator Manual 24001-EN Rev C...

  • Page 45: Spot Size Warning

    TxCell is connected and pattern delivery is chosen, the S displays as shown below. For TANDBY SCREEN complete information on TxCell, refer to the TxCell Scanning Laser Delivery System Operator Manual. ® 24001-EN Rev C Iridex 577 Laser System Operator Manual...

  • Page 46: Txcell Pattern Editor

    Spacing. Use the touchscreen or control knob to select and activate the field; use the control knob to adjust the spacing between spots for all patterns. Cancel. Select to cancel any changes and return to the S TANDBY SCREEN ® Iridex 577 Laser System Operator Manual 24001-EN Rev C...

  • Page 47: Txcell Options Via The Settings Menu

    ETTINGS CREEN Pattern Illumination. Use the control knob to adjust the pattern illumination intensity from 1 (dimmest) to 20 (brightest). Pattern Editor. Select to go to the TxCell Pattern Editor. ® 24001-EN Rev C Iridex 577 Laser System Operator Manual...

  • Page 48: Alignment Verification

    1. Look through the slit lamp oculars to verify that the Console Aiming Beam is within the borders of the Scanner Pattern Illumination. 2. If the observed circle is outside of the square, do not treat with pattern scanning and contact Iridex Technical Support. You may treat using TxCell with single-spot delivery. See “Iridex Corporation...

  • Page 49: Select Preset Screen

    Presets List. Select the desired preset from the list, and then either double click the selected preset, or press the white arrow in the selected preset row, or press <Standby to save the selection and return to the S TANDBY CREEN ® 24001-EN Rev C Iridex 577 Laser System Operator Manual...

  • Page 50: Prepare To Treat Screen

    Prepare to Treat Screen This screen appears briefly as a transition screen from Standby to ReadyToTreat. ® Iridex 577 Laser System Operator Manual 24001-EN Rev C...

  • Page 51: Ready-To-Treat Screens

    Selected Preset. Displays the name of the selected preset. Power Adjustment. The Power field defaults to the activated field in the R EADY REAT . Use the control knob to adjust Power. SCREEN ® 24001-EN Rev C Iridex 577 Laser System Operator Manual...

  • Page 52: Standard Slit Lamp Adapter (Sla)

    Standard Slit Lamp Adapter (SLA) For treatment with Iridex standard SLAs, the R adds a Spot Size field as shown EADY REAT SCREEN below. Delivery Device. Displays the name of the connected delivery device. Spot Size. Displays the spot size selected on the SLA Spot Size dial.

  • Page 53: Txcell ™ Scanning Laser Delivery System

    ™ TxCell Scanning Laser Delivery System For treatment with an Iridex TxCell, the R adds a Spot Size field as shown below. EADY REAT SCREEN Delivery Device. Displays the name of the connected delivery device. Spot Size. Displays the spot size selected on the TxCell spot size dial.

  • Page 54: Treating Screens

    Total Energy. This is visible only when Display Total Energy is On in the O PERATIONAL ARAMETERS SCREEN Displays selected Treatment mode. Displays Total Shots. Displays accumulated number of shots fired during treatment. Displays selected Power. Indicates laser is firing. ® Iridex 577 Laser System Operator Manual 24001-EN Rev C...

  • Page 55: Standard Sla And Txcell Scanning Laser Delivery System

    Standard SLA and TxCell Scanning Laser Delivery System For treatment with either a standard SLA or TxCell Scanning Laser Delivery System, the T REATING adds a Spot Size field as shown below. SCREEN ® 24001-EN Rev C Iridex 577 Laser System Operator Manual...

  • Page 56: Treatment Report Screen

    Use the arrows on the right to scroll up or down as necessary. Export. Select to export the selected treatment report to USB. For more information, see “Exporting Treatment Reports”. ® Iridex 577 Laser System Operator Manual 24001-EN Rev C...

  • Page 57: Treating Patients

    9. If a contact lens was used, handle the lens according to the manufacturer’s instructions. 10. Keep the protective cap over the fiber-optic connector when the delivery device is not in use. ® 24001-EN Rev C Iridex 577 Laser System Operator Manual...

  • Page 58: Troubleshooting

    Key Switch to “On.” 2. If error does not clear, contact Iridex. * If the user actions are not successful, contact Iridex. See “Iridex Corporation Contact Information” for Iridex contact information. Laser Indirect Ophthalmoscope Related Problems...
  • Page 59 • The laser treatment parameters may be too close to the tissue response threshold for consistent response. Increase the laser power and/or exposure duration, or select a different lens. * If the user actions are not successful, contact Iridex. See “Iridex Corporation Contact Information” for Iridex contact information.

  • Page 60: Maintenance

    WARNING: Do not remove covers! Removing covers and shields may result in exposure to dangerous optical radiation levels and electrical voltages. Only Iridex-trained personnel may access the interior of the laser. The laser has no user-serviceable parts. ®...

  • Page 61: Verifying The Power Calibration

    Verifying the Power Calibration To ensure that calibration meets the requirements of the National Institute of Standards and Technology (NIST), the laser treatment power is calibrated at the Iridex factory with a power meter and an Iridex delivery device with previously measured transmission.
  • Page 62 Interval (ms) 1000–3000 80-120 1000–3000 200-300 1000–3000 1000 400-600 1000–3000 2000 800-1200 Data for power measurement equipment: _________________________ Calibration date: __________________ Meter Model and Serial Number: _________________________ Calibrated by: __________________ ® Iridex 577 Laser System Operator Manual 24001-EN Rev C...

  • Page 63: Safety And Compliance

    Maximum available laser power and associated NA vary with each delivery device, resulting in unique NOHD values for each delivery device. ® 24001-EN Rev C Iridex 577 Laser System Operator Manual...

  • Page 64: Safety Compliance

    1.800 33.9 Device Optical density of laser safety glasses used with Iridex 577 (maximum output power of 2 W) should have an OD ≥ 4 at 577 nm. Safety Compliance Complies with 21 CFR 1040.10 and 1040.11 except for conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed.
  • Page 65 The console cannot be placed in Treat mode if the footswitch is Footswitch damaged or improperly connected. The footswitch can be cleaned (IPX8 per IEC60529) and is shrouded for safety (ANSI Standard Z1363, 4.3.1). ® 24001-EN Rev C Iridex 577 Laser System Operator Manual...

  • Page 66: Labels

    Labels NOTE: The actual label may vary with laser model. Serial Number (rear panel) Ground (bottom of laser) Footswitches ® Iridex 577 Laser System Operator Manual 24001-EN Rev C...
  • Page 67 Footswitches Footswitches ® 24001-EN Rev C Iridex 577 Laser System Operator Manual...
  • Page 68 Laser Warning Rear panel of console ® Iridex 577 Laser System Operator Manual 24001-EN Rev C...

  • Page 69: Symbols (As Applicable)

    Registered safety signs Refer to Graphical To signify that the ISO 7010-M002 instruction symbols—Safety instruction manual/booklet colours and manual/booklet must safety signs— be read Registered safety signs ® 24001-EN Rev C Iridex 577 Laser System Operator Manual...
  • Page 70 Symbols to be catalogue number so 5.1.6. (ISO 7000- used with that the medical 2493) information to be device can be supplied by the identified manufacturer— Part 1: General requirements ® Iridex 577 Laser System Operator Manual 24001-EN Rev C...
  • Page 71 Reference no. the European Symbols to be representative in the 5.1.2. Community/ used with European European Union information to be Community/European supplied by the Union manufacturer— Part 1: General requirements ® 24001-EN Rev C Iridex 577 Laser System Operator Manual...
  • Page 72 Manufacture devices— when the medical Reference no. Symbols to be device was 5.1.3. (ISO 7000- used with manufactured 2497) information to be supplied by the manufacturer— Part 1: General requirements ® Iridex 577 Laser System Operator Manual 24001-EN Rev C...
  • Page 73 (ground) electrode Fuse Graphical To identify fuse IEC 60417 (IEC symbols for use boxes or their 60417-5016) on equipment location ® 24001-EN Rev C Iridex 577 Laser System Operator Manual...
  • Page 74 Computer Graphical To identify the IEC-60878 network symbol for computer network Symbol 5988 electrical itself or to indicate equipment in the connecting medical practice terminal of the computer network ® Iridex 577 Laser System Operator Manual 24001-EN Rev C...
  • Page 75 – Symbols to be temperature limits to Reference no. used with which the medical 5.3.7 information to be device can be safely supplied by the exposed manufacturer – Part 1: General requirements ® 24001-EN Rev C Iridex 577 Laser System Operator Manual...

  • Page 76: Product Symbols

    Product Symbols Symbol Title Decrease/Increase Emergency Stop Footswitch Gauge Illumination Laser Aperture at End of Fiber Remote Interlock ® Iridex 577 Laser System Operator Manual 24001-EN Rev C...

  • Page 77: User Interface Symbols And Icons

    Delete Report, Delete Preset Emergency Stop Error Expand/Collapse List Export Report Note: If the icon is greyed out as shown below, the Export Report feature is not enabled on the laser. ® 24001-EN Rev C Iridex 577 Laser System Operator Manual...
  • Page 78 Laser Firing/Treating New Treatment Export Complete Operational Parameters Pattern Editor Prepare to Treat Preset Favorites Presets Ready to Treat Rotation Scroll Up/Scroll Down List Service. For Iridex Service Only Spot Spacing ® Iridex 577 Laser System Operator Manual 24001-EN Rev C...
  • Page 79 Note: If the icon is greyed out as shown below, the MicroPulse Treatment Option is not enabled on the laser. Treatment Mode, Unlock/Lock Treatment Reports TxCell Scanner View Treatment Report ® 24001-EN Rev C Iridex 577 Laser System Operator Manual...

  • Page 80: Specifications

    Specifications Specification Description Treatment wavelength 577 nm Treatment power 50 – 2000 mW (delivered), depending on delivery device. Duration CW-Pulse: 10 ms – 3000 ms or CW to 60 seconds MicroPulse (Optional): 0.05 ms – 1.0 ms Repeat interval CW-Pulse: 10 ms –...

  • Page 81: Wireless Footswitch (Optional) And Emc

    • Right pedal = increase power (hold down to ramp the parameter) CAUTION: Each footswitch/receiver pair is uniquely linked and will not work with other Iridex footswitches or similar components. Clearly identify each pair to prevent separation of the linked components.

  • Page 82: Emc Guidance

    Connect the laser console into an outlet on a circuit different from that to which the receiver is connected. • Consult Iridex Customer Service for help. This Class B digital apparatus meets all requirements of the Canadian Interference-Causing Equipment Regulations.

  • Page 83: Guidance And Manufacture's Declaration - Electromagnetic Emission

    ±1 kV line(s) to ±1 kV differential Mains power quality should be that of a typical line(s) mode commercial or hospital environment. ±2 kV line(s) to ±2 kV common earth mode ® 24001-EN Rev C Iridex 577 Laser System Operator Manual...
  • Page 84 If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the laser. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than V/m. ® Iridex 577 Laser System Operator Manual 24001-EN Rev C...

  • Page 85: Recommended Separation Distances Between Portable And Mobile Rf Communications Equipment And The Laser

    NOTE: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. ® 24001-EN Rev C Iridex 577 Laser System Operator Manual...