Iridex IQ 577 Operator's Manual
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Iridex IQ 577 Operator's Manual

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IRIDEX IQ 577
/IQ 532
®
®
Laser Systems
Operator Manual

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Summary of Contents for Iridex IQ 577

  • Page 1 IRIDEX IQ 577 /IQ 532 ® ® Laser Systems Operator Manual...
  • Page 2 BriteLight, CW-Pulse, DioPexy, EasyFit, EasyView, FiberCheck, FlexFiber, G-Probe, IQ 532, IQ 577, IQ 810, LongPulse, MicroPulse, MilliPulse, OtoProbe, PowerStep, SmartKey, Symphony, Tri-Mode, TruFocus, and TruView are trademarks of IRIDEX Corporation. All other trademarks are the property of their respective holders.

  • Page 3: Table Of Contents

    Introduction ..................1 Compatible Delivery Devices ..................1 Pulse Types ........................1 References ........................3 Indications for Use - IQ 577 Models ................3 Indications for Use - IQ 532 Models ................5 Warnings and Cautions ....................10 IRIDEX Corporation Contact Information ............... 11 Setup ....................12 Unpacking the System ....................12...
  • Page 4 Contents 15510-EN Rev G...

  • Page 5: Introduction

    Follow the instructions for use described in this operator manual. Compatible Delivery Devices These IRIDEX delivery devices are compatible with the IQ 577 and IQ 532 laser systems: • TxCell Scanning Laser Delivery System ®...
  • Page 6 MicroPulse, is spacing between laser treatment spots, and the total number of treatment spots administered. Due to the limited thermal spread of 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. 2 IRIDEX IQ 577 /IQ 532 Laser Systems Operator Manual 15510-EN Rev G ®...

  • Page 7: References

    Individual treatment should be based on clinical training, clinical observation of laser tissue interaction, and appropriate clinical endpoints. The IRIDEX laser and the handpieces, delivery devices, and accessories that are used with it to deliver laser energy in CW-Pulse™ or MicroPulse™ mode in the medical specialty of Ophthalmology.
  • Page 8 The operative needs of each patient should be individually evaluated based on the indication, treatment location, and on the patient’s medical and wound healing history. If uncertain of expected clinical response, always start with a conservative setting and increase the setting in small steps. 4 IRIDEX IQ 577 /IQ 532 Laser Systems Operator Manual 15510-EN Rev G ®...

  • Page 9: Indications For Use - Iq 532 Models

    The IRIDEX laser and the handpieces, delivery devices, and accessories that are used with it to deliver laser energy in CW-Pulse™ mode or MicroPulse™ mode in the medical specialties of Ear, Nose and Throat (ENT), and Ophthalmology.
  • Page 10 • Iridotomy, iridoplasty in angle closure glaucoma, and trabeculoplasty in open angle glaucoma Procedural Recommendations The user is directed to review the operating instructions for the compatible delivery devices prior to treatment. Contraindications • Any situation where the target tissue cannot be adequately visualized or stabilized. • Do not treat albino patients who have no pigmentation. 6 IRIDEX IQ 577 /IQ 532 Laser Systems Operator Manual 15510-EN Rev G ® ®...
  • Page 11 The following sections provide information and safety guidelines, which can greatly decrease the risks associated with these procedures. Information is also provided on what to do if such a fire does occur. IRIDEX Corp. recommends the safety guidelines of American National Standards ANSI Z136.3-2007 as follows: • Care must be taken to protect endotracheal tubes from laser radiation. Ignition or perforation of endotracheal tubes by the laser beam could result in serious or fatal patient complications.
  • Page 12 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. 8 IRIDEX IQ 577 /IQ 532 Laser Systems Operator Manual 15510-EN Rev G ®...
  • Page 13 532 nm Typical Laser Treatment Parameters for ENT Photocoagulation Otology Treatment Delivery Device Spot Size at Power Exposure Target (µm)** (mW) Duration (ms) Stapedectomy 800–2500 100–2500 Stapedotomy Myringotomies Removal of Acoustic Neuromas Otoprobe 200–2500 20–100 Soft Tissue Adhesion in Micro/Macro Otologic Procedures Lysis of Adhesions 1000–2500...

  • Page 14: Warnings And Cautions

    Laser plume may contain viable tissue particulates. Keep the protective cap over the fiber-optic connector when the delivery device is not in use. 10 IRIDEX IQ 577 /IQ 532 Laser Systems Operator Manual 15510-EN Rev G ®...

  • Page 15: Iridex Corporation Contact Information

    IRIDEX service personnel. 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.

  • Page 16: Setup

    Setup Unpacking the System Make sure you have all components that were ordered. Check components for damage before use. NOTE: Contact your local IRIDEX Customer Service Representative if there are problems with your order. Laser Wireless Footswitch Remote Control (optional)

  • Page 17: Choosing A Location

    Choosing a Location Choose a well-ventilated location within the specified operating range of the console. Place the laser system on a table or on existing operating room equipment. Allow at least 5 cm (2 in.) of clearance on each side. In the US, this equipment must be connected to an electrical supply source at 120V or 240V with a center tap.
  • Page 18 Rear Panel Connectors - IQ 532/IQ 577 ETL CLASSIFIED Conforms To AAMI STD ES60601-1, IEC STDS 60601-2-22, 60601-1-6, 60825-1, 62304 Certified To CSA STD C22.2 Nos 60601-1 & 60601-2-22 LASER RADIATION AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION...

  • Page 19: Operation

    Operation Front Panel Controls Touchscreen display Treat/Standby button Fiber ports (See Caution Control knobs (3) below) LIO connector Keyswitch SmartKey Emergency Stop button CAUTION: When no delivery device is attached to the system, ensure that the fiber ports are closed. Powering the Laser On and Off • To turn the laser on, turn the key to the On position.

  • Page 20: Treating Patients

    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. 16 IRIDEX IQ 577 /IQ 532 Laser Systems Operator Manual 15510-EN Rev G ®...

  • Page 21: Using The Laser System

    Using the Laser System System Interface Touchscreen Displays current parameter and functions, and acts as the interface to select Interface screens or parameters. Control knobs Used to adjust parameters on the screen. Laser button Toggles between laser Ready and Standby modes. 15510-EN Rev G Operation 17...
  • Page 22 WARNING: Except during actual treatment, the laser must always be in Standby mode. Maintaining the laser in Standby mode prevents accidental laser exposure if the footswitch is inadvertently pressed. 18 IRIDEX IQ 577 /IQ 532 Laser Systems Operator Manual 15510-EN Rev G ®...
  • Page 23 liO i NtENsity imiNg EttiNgs Displays LIO and Aiming Beam intensity. Use control knobs to adjust. Save changes and return to previous screen. icrO ulsE EttiNgs ptiONal Turn MicroPulse ON or OFF. Select preset values for Duty Cycle. MicroPulse duration and Interval parameters update automatically. Displays MicroPulse duration and interval.
  • Page 24 Selection button to load highlighted preset and go to Standby screen. Cancel loading preset selection and return to Standby screen. Go to Presets Screen to view, update and/or select preset parameters. 20 IRIDEX IQ 577 /IQ 532 Laser Systems Operator Manual 15510-EN Rev G ®...
  • Page 25 Presets Screen To access the Presets screen, at the Preset Menu, touch V Go to Previous/Next Preset. (Optional) Adjust MicroPulse settings. Use control knobs to select pulse duration, power, and interval. Displays Preset name. Press to enter Keyboard mode. Save changes and return to Treat screen. Discard changes and return to Treat screen with default parameters.
  • Page 26 2. Turn off the laser console 3. Allow the unit to power down, approximately 15 seconds 4. Turn on the laser console 5. If the problem persists, contact your local IRIDEX Technical Support representative. 22 IRIDEX IQ 577 /IQ 532...
  • Page 27 Options Screen To access the Options screen, touch o ptionS Set aiming beam in Standby: ON or OFF. Set aiming beam in Treat: • OFF: Aiming beam OFF while footswitch is depressed. • ON: ON at all times. • Blink: Blink at fixed rate (not synchronized with laser settings). Set voice prompt: Female, Male, OFF.

  • Page 28: Troubleshooting

    • Verify that the fiber-optic connector is not damaged. • If possible, connect another IRIDEX delivery device and place the console in Treat mode. If the aiming beam is still not visible, contact your local IRIDEX Technical Support representative. No treatment beam •...
  • Page 29 • Turn on the aiming beam to determine focus position and adjust as necessary. View is blocked or partially Set magnification to 10X or more. blocked by OMA (OMA* only) * Operating microscope adapter compatible with IRIDEX IQ 810 and SLx Systems. 15510-EN Rev G Troubleshooting 25...

  • Page 30: Error Messages

    Photocell detector not responding. E06101 Laser output detected in wrong port. E06200, E06201 Invalid current detected at LCM shunt. E08000 Software load failure in UIM. 26 IRIDEX IQ 577 /IQ 532 Laser Systems Operator Manual 15510-EN Rev G ® ®...
  • Page 31 “Delivery device or SmartKey not connected.” You can clear the message; however, you cannot fire the laser until a delivery device or SmartKey is connected. Refer to the table below for corrective actions. If a user action does not correct the problem, contact IRIDEX Service. Event / Error Code Error Message...
  • Page 32 Verify a 577 nm eye Confirmation of eye safety filter If using a 2-position filter, safety filter is in place. is required before laser enters connect SmartKey. Treat mode. 28 IRIDEX IQ 577 /IQ 532 Laser Systems Operator Manual 15510-EN Rev G ® ®...

  • Page 33: 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 34: Verifying The Power Calibration

    IRIDEX delivery device. 13. If the readings are still outside the acceptable levels, contact your local IRIDEX Technical Support Representative. 14. Place a signed copy of the table in your device records to refer to during use and service.
  • Page 35 Power Measurements using a CW Delivery Device Power (mW) Exposure Duration (ms) Meter Reading (mW) Acceptable Range (mW) 1000–3000 160–240 1000–3000 400-600 1000 1000–3000 800-1200 2000 1000–3000 1600-2400 Data for power measurement equipment: _______________ Calibration date: _______________ Meter Model and Serial Number: _______________ Calibrated by: _______________ Power Measurements using a MicroPulse Delivery Device...

  • Page 36: Safety And Compliance

    Always wear appropriate laser safety eye wear when performing or observing laser treatments with the unaided eye. Protection for All Treatment Room Personnel The Laser Safety Officer should determine the need for safety eyewear based on the Maximum Permissible Exposure (MPE), Nominal Ocular Hazard Area (NOHA), and Nominal Ocular Hazard Distance (NOHD) for each of the delivery devices used with the laser system, as well as the configuration of the treatment room. For additional information, refer to ANSI Z136.1, ANSI Z136.3, or European Standard IEC 60825-1. 32 IRIDEX IQ 577 /IQ 532 Laser Systems Operator Manual 15510-EN Rev G ® ®...
  • Page 37 MPE = the level of laser radiation, in W/m , to which a person may be exposed without suffering adverse events Numerical aperture is equal to the sine of the half-angle of the emerging laser beam. Maximum available laser power and associated NA vary with each delivery device, resulting in unique NOHD values for each delivery device. NOTE: Not all delivery devices are available for all laser models. IQ 577/IQ 532 NOHD Values for Various Delivery Devices Maximum Numerical Φ Aperture Power NOHD Delivery Device...

  • Page 38: Safety Compliance

    The laser cannot be placed in Treat mode if the footswitch is damaged or improperly connected. The footswitch can be immersed and cleaned (IPX8 per IEC60529) and is shrouded for safety (ANSI Standard Z136.3, 4.3.1). 34 IRIDEX IQ 577 /IQ 532 Laser Systems Operator Manual 15510-EN Rev G ®...

  • Page 39: Labels

    Fax: (31) (0) 70 346-7299 Mountain View, CA 94043 USA Tel: 650-940-4700 Fax: 650-940-4710 0086 www.iridex.com MADE IN THE USA LABEL P/N: 31792-1F Customer Supplied Prints Responsibility for Validation and Fitness-of-Use: THIS PRINT MUST BE APPROVED AND RETURNED WITHIN 24 Because Valmark Industries, Inc.
  • Page 40 IRIDEX APP BY: DATE: PART #: 65888 THIRD ANGLE PROJECTION Patent: http://iridex.com/patents.aspx SCALE: REV: APPROVAL PRINT SHEET: 1 OF 1 1.220" PN 65893 Rev E 36 IRIDEX IQ 577 /IQ 532 Laser Systems Operator Manual 15510-EN Rev G ® ®...

  • Page 41: Symbols (As Applicable)

    Symbols (As Applicable) Aiming Beam Angle Aspirating Probe Caution Audible Signal CE Mark 2797 Do Not Use Connector Type if Package is Duration Damaged Duration with Emergency Stop ETL Mark MicroPulse EU Authorized EtO Sterile Expiration Date Representative Footswitch Footswitch In Footswitch Out Protective Earth Fuse...

  • Page 42: Specifications

    Specifications Specification Description Treatment wavelength IQ 577: 577 nm IQ 532: 532 nm IQ 577: Treatment power 50 – 2000 mW (delivered), depending on delivery device. IQ 532: 50 – 2500 mW (delivered), depending on delivery device.
  • Page 43 Specification Description Electrical 100 – 240 VAC, 50/60 Hz, <3 A Cooling Air cooled Operating temperature range 10° C to 35° C (50° F to 95° F) Storage temperature range -20° C to 60° C (-4° F to 140° F) Relative humidity 20% to 80% non-condensing ×...

  • Page 44: Wireless Footswitch And Emc

    • Left pedal = decrease power (hold down to ramp the parameter) • Center pedal = activate laser • 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. NOTE: The footswitch is designed to operate within 15 feet (5 meters) of the laser.

  • Page 45: Emc Safety Information

    • Reorient or relocate the receiving device. • Increase the separation between the equipment. • 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. Cet appareil numérique de la classe B respecte toutes les exigences du Réglement sur le matériel brouilleur du Canada. 15510-EN Rev G...

  • Page 46: Emc Requirements For Console And Accessories

    The laser system is suitable for use in all establishments, other than domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. 42 IRIDEX IQ 577 /IQ 532 Laser Systems Operator Manual 15510-EN Rev G ®...
  • Page 47 Guidance and Manufacturer’s Declaration - Immunity This laser system (console and accessories) is intended for use in the electromagnetic environment specified below. The customer or the user of the laser system should assure that it is used in such an environment. Electromagnetic Environment - Immunity Test...
  • Page 48 If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the laser system. b: Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. 44 IRIDEX IQ 577 /IQ 532 Laser Systems Operator Manual 15510-EN Rev G ®...
  • Page 49 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the Wireless Footswitch. The wireless footswitch is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the wireless footswitch can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the wireless footswitch as recommended below, according to the maximum output power of the communications equipment.

This manual is also suitable for:

Iq 532

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