Norlase LION Operator's Manual

Norlase LION Operator's Manual

Laser indirect ophthalmoscope
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Laser Indirect Ophthalmoscope
Norlase ApS
Brydehusvej 13
Ballerup 2750 DENMARK
Phone: +45 93 97 74 72
Operator Manual
®
Norlase Inc. USA
895 Hurlingame Ave.
Redwood City, CA 94063
Phone: +1.650.489.0083
Toll Free 833.667.5273 USA Only
USA

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Summary of Contents for Norlase LION

  • Page 1 ® Laser Indirect Ophthalmoscope Operator Manual Norlase ApS Norlase Inc. USA Brydehusvej 13 895 Hurlingame Ave. Ballerup 2750 DENMARK Redwood City, CA 94063 Phone: +45 93 97 74 72 Phone: +1.650.489.0083 Toll Free 833.667.5273 USA Only...
  • Page 2 Norlase. 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 3: Table Of Contents

    AIRING CABLE ................................ 9 ABLET TAND ............................... 9 ANUAL DEVICE PREPARATION AND SETUP ........................ 10 LION ....................... 11 ETTING UP AND USING THE ORLASE ............................. 12 DJUSTING THE HEADBAND Comfortable Fit ............................12 Ophthalmoscope Angle Alignment ......................12 ......................13...
  • Page 4 LEANING THE ABLET ONTROL ANEL CREEN ..........................39 NSPECTING THE EADSET ABLE NORLASE LION SPECIFICATIONS ........................40 NORLASE LION POWER SUPPLY SPECIFICATIONS ................... 44 TROUBLESHOOTING GUIDE ..........................45 LION L ..................48 AIRING AN NPAIRED ABLET WITH ASER ONSOLE LION L ..................
  • Page 5 ETURNS DJUSTMENTS ......................88 ECONTAMINATION OF ETURNED QUIPMENT US T ........................88 ECHNICAL ERVICE NFORMATION .......................... 89 ECONTAMINATION ERTIFICATION WEEE D ..............................90 ISPOSAL LION User Manual P/N: 97-4001-05, Revision 05, Release date: January 28, 2021 Page 5 of 90...
  • Page 6: Indications For Use / Intended Use

    Introduction The Norlase LION is a Laser Indirect Ophthalmoscope where the laser source is built into the headset, eliminating the need for an external laser console. LION is controlled via a wireless tablet user interface utilizing touch screen or voice control of parameters. LION is powered by a rechargeable battery built into the foot switch.
  • Page 7: Package Contents

    Laser Indirect Ophthalmoscope The Norlase LION is a laser indirect ophthalmoscope with the laser console integrated into the headset. The laser console located on the back of the headset houses the key switch, emergency laser stop button, foot switch and power inputs, green treatment laser, red aiming laser, and control electronics.
  • Page 8: Touchscreen Tablet Control Panel

    The tablet Operating System (OS) and other control functions are locked (kiosk mode) to prohibit the installation and use of any consumer grade applications. The tablets sole use is intended for the operation of Norlase LION photocoagulator. The use of any unauthorized applications may affect the performance of the device and is prohibited.
  • Page 9: Footswitch With Battery

    Activates laser treatment beam when depressed while device is in READY mode.The battery is built into the foot switch shroud and powers both the white light illumination and laser sources. Norlase LION Power Supply Medical grade power supply to be connected between wall outlet and the charging connection on the foot switch.
  • Page 10: Device Preparation And Setup

    Optimal device performance and viewing is achieved in low ambient light conditions. Norlase LION power supply used for charging the battery is equipped with a 2-wire AC power cord. Follow local electrical codes to ensure proper wiring of the AC wall power outlet.
  • Page 11: Setting Up And Using The Norlase Lion

    Setting up and using the Norlase LION The Norlase LION is a fully self contained laser delivery device built into the viewing path of the binocular block. The user can adjust the angle of projection of the laser by approximately +/- 3 degrees.
  • Page 12: Adjusting The Headband

    Position the Binocular Block as close to the eyes or spectacles as possible for maximum field of view. Slightly loosen the ophthalmoscope angle knob to allow for adjustment and tighten when in position. Angle Adjust Knob LION User Manual P/N: 97-4001-05, Revision 05, Release date: January 28, 2021 Page 12 of 90...
  • Page 13: Interpupillary Distance Setting Control

    Repeat for the other eye. Obtaining a fused image Ensure that a singular, fused image is obtained as follows: LION User Manual P/N: 97-4001-05, Revision 05, Release date: January 28, 2021 Page 13 of 90...
  • Page 14: White Light Illumination

    White Light Illumination Turn the illumination on by rotating the headband dimmer in the clockwise direction. White Light Illumination Control LION User Manual P/N: 97-4001-05, Revision 05, Release date: January 28, 2021 Page 14 of 90...
  • Page 15: Setting The Illumination Aperture

    Setting the Illumination Aperture Select different apertures by rotating the lever on the left side of the unit. The Norlase LION has three light apertures which offer maximum stereopsis. When you select the aperture, the illumination and viewing mirrors automatically adjust for maximum stereopsis.
  • Page 16: Headset Illumination And Laser Angle Adjustment

    Refer to the following diagrams for the location of device component connections on the side panels of the laser console. Side Panel Functions Laser Key Switch Emergengy Off Button Laser Console Side Panel LION User Manual P/N: 97-4001-05, Revision 05, Release date: January 28, 2021 Page 16 of 90...
  • Page 17: Bottom Panel Functions

    Solid Red – System Error, Turn Key OFF then ON Flashing Red – System Error with No Tablet Connected, Turn Key OFF then ON and connect tablet LION User Manual P/N: 97-4001-05, Revision 05, Release date: January 28, 2021 Page 17 of 90...
  • Page 18: Foot Switch Panel Functions

    Foot Switch Panel Charging the LION Battery The charging port for the LION battery is located on the rear of the foot switch. Plug in the supplied power supply to a wall outlet (100-240 VAC) and the output end into the battery charging port.
  • Page 19: Laser Spot Size Considerations

    28D Lens = 513 µm on the retina o 30D Lens = 550 µm on the retina The above is an example only. The refraction power will vary patient to patient. LION User Manual P/N: 97-4001-05, Revision 05, Release date: January 28, 2021 Page 19 of 90...
  • Page 20: Device Start-Up And Shut-Down

    Device Start-up and Shut-down Starting the Device 1. Prior to mounting the headset, connect the LION headset cable to rear of foot switch mating cable receptacle. Please note this connector is keyed, so it must be inserted in the proper orientation with the arrow on the connector facing UP.
  • Page 21 Key Switch ON Key Switch OFF 5. Press and hold the power button of the display tablet until the tablet powers up and the Norlase User interface Home screen is displayed. Power Button LION User Manual P/N: 97-4001-05, Revision 05, Release date: January 28, 2021...
  • Page 22 6. The laser status LED on the back of the headset will illuminate green when the tablet and laser have established a connection. System Status LED LION User Manual P/N: 97-4001-05, Revision 05, Release date: January 28, 2021 Page 22 of 90...
  • Page 23: Shutting Down The Device

    If the power cable is still connected to the foot switch electrical source, some internal circuits remain energized (current comsumption is less than 0.1 Watts). The LION headset illumination light will still be active even if the system is powered OFF. If leaving the cable plugged into the foot switch, ensure the illumination control on the headset is turned OFF to prevent battery drain.
  • Page 24: Emergency Shut-Down

    Turn the key switch to the OFF position for 10 seconds then back to the ON position to evaluate if the device will return to normal function. Emergency Off Switch LION User Manual P/N: 97-4001-05, Revision 05, Release date: January 28, 2021 Page 24 of 90...
  • Page 25: Home Screen (Default Display)

    Home Screen (Default Display) LION User Manual P/N: 97-4001-05, Revision 05, Release date: January 28, 2021 Page 25 of 90...
  • Page 26: Using The Touchscreen Interface

    A setting may also be incremented to the next higher or lower value by touching the “ ” or “ “ next to each parameter. LION User Manual P/N: 97-4001-05, Revision 05, Release date: January 28, 2021 Page 26 of 90...
  • Page 27: Changing Laser Status, Laser Mode, Aiming Beam Power, And Counter Reset

    Please Note: The Pulse Count can only be reset by pressing the RESET button. Power cycling the system will still display the previous pulse count number. LION User Manual P/N: 97-4001-05, Revision 05, Release date: January 28, 2021 Page 27 of 90...
  • Page 28: Using Voice Control (Optional Feature)

    The voice control feature works by listening for a “wake up” command, “OK Norlase”, which activates the tablet to listen for the proper parameter change command. When a command has been successfully recognized, the tablet will audibly call back the requested command and any parameter setting that has been changed.
  • Page 29 The wake-up phrase will activate the tablet to listen for a recognized command. Immediately ♬ after hearing “OK Norlase” the tablet will respond with a two-step audible tone ( ) that indicates it is listening for the next command. The next command must be issued within 5 seconds or the tablet will return to listening for the wake-up word to be said again.
  • Page 30: List Of Voice Commands

    List of Voice Commands: ♬ indicates audible tone heard after “OK Norlase” XXX Indicates Current value will be read Full Command Command Device Action Audible Response “OK Norlase” ♬ Places the device into Enter Treat Treat Mode Selected the “Ready” Mode “Enter Treat”...
  • Page 31: Tablet Volume Control

    The tablet audio volume may be adjusted by using the slider control under the icon Touch the icon to display the slider. Adjust the slider to the desired volume level. LION User Manual P/N: 97-4001-05, Revision 05, Release date: January 28, 2021 Page 31 of 90...
  • Page 32: Changing Background Color On Tablet

    The tablet background color may be changed from blue (default) to gray if desired. 1. Touch the SETTINGS tab. 2. Select the desired BLUE or GRAY tablet theme color LION User Manual P/N: 97-4001-05, Revision 05, Release date: January 28, 2021 Page 32 of 90...
  • Page 33: Presets Menu

    1. Select the “PRESETS” Tab at the top of the screen and press “ADD NEW”. 2. Set the parameters to the desired level. When done press the “PENCIL” icon to enter the Preset name. LION User Manual P/N: 97-4001-05, Revision 05, Release date: January 28, 2021 Page 33 of 90...
  • Page 34 3. A keyboard will be displayed. Enter the name of the Preset and press “DONE”. 4. The Preset will be saved and will show on the list for future recall. LION User Manual P/N: 97-4001-05, Revision 05, Release date: January 28, 2021...
  • Page 35: Settings Tab

    The information provided are the total number of pulses in parentheses next to the identifying treatment and then the number of pulses for each Power, Duration, Interval and spot size change made during the procedure. LION User Manual P/N: 97-4001-05, Revision 05, Release date: January 28, 2021 Page 35 of 90...
  • Page 36: Aligning The Laser To The Visual And Illumination Axes

    Laser angle adjustment The vertical angle of projection of the laser can be adjusted up or down the front mounted control. Illumination and Laser Position Adjustment LION User Manual P/N: 97-4001-05, Revision 05, Release date: January 28, 2021 Page 36 of 90...
  • Page 37: Intraoperative Instructions

    Intraoperative Instructions Laser Indirect Ophthalmoscope Treatment Procedure NOTE: Use of the LION is limited to physicians trained to perform photocoagulation with a Laser Indirect Ophthalmoscope. Connect the LION headset cable to the foot switch/battery. Verify that the headset is properly mounted and the PD settings are correct.
  • Page 38: Between Patient Treatments

    Inspection and Cleaning The following procedures can be performed by the user to ensure proper performance of Norlase LION. During inspection and cleaning, the device shall be disconnected from the AC wall power outlet. Cleaning the Laser Console External Surfaces Clean the external surfaces of the laser console daily, after use.
  • Page 39: Cleaning The Tablet Control Panel Screen

    Use a soft, dry cloth to apply antistatic glass or plastic cleaner to the tablet control panel screen. Inspecting the Headset Cable Inspect the LION headset cabling for any cuts or abrasions to the cabling. If any noticeable damage has occurred, please contact Norlase Technical Support or your authorized Distributor.
  • Page 40: Norlase Lion Specifications

    Norlase LION Specifications [Specifications are subject to change without notice.] Treatment Beam Type Semiconductor Laser Wavelength 520 nm 0 – 1000 mW Power output Laser 10 ms – 1000 ms Pulse durations Pulse interval Off, 50 ms to 3000 ms...
  • Page 41 Rated Input 100-240 VAC, 50-60 Hz, 0.6 A Product Classifications per IEC 60601-1 Internally Powered ME Equipment (Class II when connected to Norlase LION power supply) Type B equipment Standard equipment, Footswitch is IPX6 Non-sterile product Equipment not suitable for use in the presence of a flammable anesthetic mixture...
  • Page 42 Standard commercial shipping altitude Non-operating temperature -10° to +55°C (14° to 131°F) Maximum humidity 85% (non-condensing) Other Expected Service Life Minimum seven years from Customer Installation LION User Manual P/N: 97-4001-05, Revision 05, Release date: January 28, 2021 Page 42 of 90...
  • Page 43 Non-CE eyewear Minimum OD of 5 at 520 nm per ANSI Z136.1 CE eyewear D LB6 at 520 nm per EN 207 Personal Eye Protection LION User Manual P/N: 97-4001-05, Revision 05, Release date: January 28, 2021 Page 43 of 90...
  • Page 44: Norlase Lion Power Supply Specifications

    Norlase LION Power Supply Specifications Norlase LION Power Supply NOTE: Use only the Norlase LION power supply to charge the battery. Using any other power supply may cause permanent device damage and risk of fire. Using any other power supply will immediately void the warranty.
  • Page 45: Troubleshooting Guide

    This will aid in the diagnosis and servicing of the equipment. If the device fails to turn on, please check for the following items. If none of these solutions remedies the problem, consult the Troubleshooting Guide, call Norlase Technical Support, or your local authorized Distributor: 1.
  • Page 46 Suggestion: Turn key switch to OFF position, wait at least five minute and then turn to ON position. If the device fails to start, contact Norlase Technical service or an authorized distributor. System User Interface is blank for more than 30 seconds.
  • Page 47 Probable Cause: Foot switch and/or foot switch cable damaged. Suggestion: Inspect for damage. If damaged call Norlase Technical Support or an authorized distributor. Probable Cause: Internal device error. Suggestion: Contact Norlase Technical Support or an authorized distributor. Other unexpected System behavior...
  • Page 48: Pairing An Unpaired Tablet With Lion Laser Console

    Pairing an Unpaired Tablet with LION Laser Console A tablet control panel is paired with a laser console at the Norlase factory. If it becomes necessary to pair a new tablet with a laser console please use the following procedure: 1.
  • Page 49: Illumination Led Replacement

    Make sure the LED is pushed all the way into the binocular block. Note that the LION should only be used with the LION LED. Ensure that the red switch on the rheostat is in the direct shown in the figure below. The symbol shown on the rheostat indicates a bulb light source.
  • Page 50: Error Messages

    Error Messages Error States If error occurs regularly, contact Norlase technical support or your authorized Distributor. Critical Error implies a safety issue that requires the device to immediately go to a safe state. Clearable Error indicates a problem with the device that requires that the device be put into a safe state until the error is acknowledged by the user or returns within specification.
  • Page 51 Battery temperature Turn Key OFF, then ON 1-100 temperature out of out-of-range Call service if error persists. range Connect the Norlase LION 1-101 Battery charger Unknown charger Power supply. Call service if error persists. Turn Key OFF, then ON &...
  • Page 52 Call service if error persists. Verify hardware is powered Failed descriptor 2-30 Bonding failure on and within range write sync Call service if error persists. LION User Manual P/N: 97-4001-05, Revision 05, Release date: January 28, 2021 Page 52 of 90...
  • Page 53 Call service if error persists. Turn Key OFF, then ON & Cable 3-11 Received READ reboot tablet communication error Call service if error persists. LION User Manual P/N: 97-4001-05, Revision 05, Release date: January 28, 2021 Page 53 of 90...
  • Page 54 Presets too long Files system error Call service if error persists. Presets failed read Reboot tablet 4-14 Files system error open Call service if error persists. LION User Manual P/N: 97-4001-05, Revision 05, Release date: January 28, 2021 Page 54 of 90...
  • Page 55 Cycle on/off Turn Key OFF, then ON Auto-Off key switch to wake it Call service if error persists. Battery is too low for Connect Norlase LION power Battery too low treatment supply. Door interlock is Close door, Check interlock...
  • Page 56 Laser Error footswitch disabled Call service if error persists. Turn Key OFF, then ON 7-10 Lost connection Laser Error Call service if error persists. LION User Manual P/N: 97-4001-05, Revision 05, Release date: January 28, 2021 Page 56 of 90...
  • Page 57: Calibration Check Procedure

    Disclaimer Warning Calibration of the Norlase LION is a service procedure to be performed only by Norlase- certified personnel. Measurement or adjustment by anyone other than Norlase-certified personnel voids any existing manufacturer’s warranty on the instrument and can result in serious personal injury.
  • Page 58: Device Relocation Instructions

    3. If a remote door interlock is utilized, remove the interlock plug and cable from the interlock port and transport separately. 4. Ensure the tablet control panel travels with the LION that it is paired with. The tablet control panels ARE NOT interchangeable with other LION systems.
  • Page 59: General Safety And Regulatory Information

    Norlase 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 60 Under some single fault conditions, the temperature of the surface shown below could get hot and there is a possible risk of a burn if touched. LION User Manual P/N: 97-4001-05, Revision 05, Release date: January 28, 2021 Page 60 of 90...
  • Page 61: Ocular Protection

    Exposure to the red diode laser aiming beam when operated at maximum intensity will exceed the safety guideline after 3.9 seconds. LION User Manual P/N: 97-4001-05, Revision 05, Release date: January 28, 2021 Page 61 of 90...
  • Page 62: Laser Safety Eyewear

    NHZ depends on the planned procedure and the equipment required to perform that procedure. Eye safety filters are provided with the Norlase LION and are required for safe use. Laser safety eyewear is not required by the physician who views the procedure through the LION eyepieces.
  • Page 63: Electrical Hazards

    The area around the headset and footswitch shall be kept dry. Do not operate the laser if any of the cords are faulty or frayed. The device should undergo routine inspection and maintenance per the Norlase manufacturer's recommendation and institutional standards. Although not required for the operation of the device, an additional staff member trained in CPR should be present any time equipment is used utilizing line voltage power.
  • Page 64: Fire Hazard

    Norlase LION. The solvents of adhesives and flammable solutions used for cleaning and disinfecting should be allowed to evaporate before the device is used. Attention should also be drawn to the danger of ignition of endogenous gases.
  • Page 65: Operational Safety

    It is the responsibility of the physician to verify that the aiming beam spot visualized through the Norlase LION is the expected size. If the aiming beam size appears inappropriate or distorted, do not proceed with treatment. If the problem persists, contact Norlase service or your authorized Distributor.
  • Page 66: Additional Safety Considerations

    If the Norlase LION is used adjacent to or stacked with other equipment, observe and verify normal operation of the Norlase LION in the configuration in which it will be used prior to use. Condensation may occur if the device is exposed to high humidity for an extended period of time.
  • Page 67: Regulatory Compliance Safety Features

    Regulatory Compliance Safety Features Norlase LION complies with 21 CFR subchapter J as administrated by the Center for Devices and Radiological Health of the Food and Drug Administration (FDA). The following FDA compliance safety features are included: Key Lock Switch The device can be activated only with the proper key to operate the master key switch.
  • Page 68: Protective Housing

    Protective Housing The laser console has a protective housing that prevents unintended human access to laser radiation above Class I limits. This housing is to be opened only by Norlase-certified personnel. Safety Interlocks The protective housing is not designed to be removed by the user during operation or maintenance.
  • Page 69: Norlase Lion Labelling

    Norlase LION Labelling Device Information Labels include: Manufacturer Reference Number Serial Number Manufacture Date User must consult instruction for use for important cautionary information such as warnings and precautions This product is to be disposed in a separate collection of electrical and...
  • Page 70 • Laser Emission Warning • Wavelength • Power • Laser Class • Standard reference USB Connections Battery Charging Port Remote Door Interlock Connection Footswitch Connection LION User Manual P/N: 97-4001-05, Revision 05, Release date: January 28, 2021 Page 70 of 90...
  • Page 71: Norlase Lion Headset Labels

    Norlase LION headset Labels Manufacturer and warning labels locations. Top: DANGER Label Location (US). Bottom: Laser warning label (EU)) LION User Manual P/N: 97-4001-05, Revision 05, Release date: January 28, 2021 Page 71 of 90...
  • Page 72: Foot Switch Label

    Left Side Labeling Right Side Labeling Foot Switch Label LION User Manual P/N: 97-4001-05, Revision 05, Release date: January 28, 2021 Page 72 of 90...
  • Page 73: Additional Labels

    Additional Labels Footswitch label Control Tablet Label Power Supply Label “XX” denotes the version number. LION User Manual P/N: 97-4001-05, Revision 05, Release date: January 28, 2021 Page 73 of 90...
  • Page 74: Electromagnetic Compatibility

    Consult the tables below for guidance in placing the device. Guidance and Manufacturer's Declaration: Electromagnetic Emissions Norlase LION is intended for use in the electromagnetic environment specified below. The customer or the user of the device should ensure that it is used in such an environment.
  • Page 75 Guidance and Manufacturer's Declaration: Electromagnetic Immunity Norlase LION is intended for use in the electromagnetic environment specified below. The customer or the user of the device should ensure that it is used in such an environment. Immunity Test IEC 60601 Test...
  • Page 76 Guidance and Manufacturer's Declaration: Electromagnetic Immunity Norlase LION is intended for use in the electromagnetic environment specified below. The customer or the user of the device should ensure that it is used in such an environment. IEC 60601 Test Immunity Test...
  • Page 77 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and Norlase LION Norlase LION is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment.
  • Page 78: Indications For Use

    Indications for Use The Norlase LION Photocoagulator is intended to be used in ophthalmic laser procedures including retinal and macular photocoagulation, iridotomy, and trabeculoplasty. Usage Precautions (Before Use) • Use of this device is limited to the treatment of ocular disease by qualified physicians in accordance with the instructions contained in this Operator Manual.
  • Page 79: Usage Precautions (During Use)

    Confirm that no reflective objects are in the laser beam path. • If the user encounters green laser flashback through the Norlase LION oculars, stop treatment and check the integrity of the laser eye safety filters before proceeding. If there is any doubt as to the integrity of the safety filters, do not use the device and call Norlase technical support or an authorized distributor.
  • Page 80 If it contacts the eye, seek medical attention immediately. • The Norlase LION is intended to be used with the specified LION LED only. Any other light source used with the Norlase LION will not function. •...
  • Page 81: Usage Precautions (After Use)

    Remove charging power cord from power outlet to disconnect system from power source. Contraindications • Foveal choroidal neovascularization (CNV) • Myopic CNV • Foveal disease LION User Manual P/N: 97-4001-05, Revision 05, Release date: January 28, 2021 Page 81 of 90...
  • Page 82: Precautions In Patient Selection

    Low intraocular transparency • Restricted pupil • Diabetes • Acute primary angle closure (with corneal edema) • Late stage glaucoma with progressed visual field loss LION User Manual P/N: 97-4001-05, Revision 05, Release date: January 28, 2021 Page 82 of 90...
  • Page 83: Precautions In Photocoagulation

    • Photocoagulation of pigmented tissue The Norlase LION 520 nm wavelength is highly absorbed by melanin. Pigmented tissue that contains melanin may be coagulated at lower power levels than tissue that does not contain melanin. It is recommended that each treatment begin with titration to set the desired clinical endpoint by starting at a low power level and gradually increase to the desired level.
  • Page 84: Adverse Effects And Complications

    Sneezing and coughing should be controlled with cough syrup or other medications. Immediately following treatment, patients should avoid altitudes over 2500 m (~8000 ft). LION User Manual P/N: 97-4001-05, Revision 05, Release date: January 28, 2021 Page 84 of 90...
  • Page 85: Anterior Segment Laser Procedures

    Interval setting is used, longer Interval settings will aid in proper tissue targeting and allow adequate physician response time in case of patient movement. LION User Manual P/N: 97-4001-05, Revision 05, Release date: January 28, 2021 Page 85 of 90...
  • Page 86: Ophthalmology References

    Trabeculoplasty Glaucoma 4:50, 1982 10. Wise JB, Errors in Laser Spot Size in Laser Trabeculoplasty Ophthalmology, 91:186, 1984 11. Kanski JJ, Clinical Ophthalmology, Second Edition. Butterworths, 1989 LION User Manual P/N: 97-4001-05, Revision 05, Release date: January 28, 2021 Page 86 of 90...
  • Page 87: Cleaning

    Department. The warranty does not apply in the event of misuse, negligence or accidental damage. The liability of Norlase under valid warranty claims is limited to repair or replacement at Norlase’s facility or purchaser's place of business (or, if not practicable, a refund of the purchase price, all at the option of Norlase).
  • Page 88: Decontamination Of Returned Equipment

    To comply with United States postal regulations and federal transportation law, devices shipped to Norlase 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 89: Decontamination Certification

    The undersigned also agrees to reimburse Norlase for any costs incurred in decontaminating the enclosed equipment, in the event said item is received by Norlase in a contaminated condition.
  • Page 90: Weee Disposal

    WEEE Disposal Contact your local representative for disposal information. LION User Manual P/N: 97-4001-05, Revision 05, Release date: January 28, 2021 Page 90 of 90...

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