Norlase Leaf Operator's Manual
  1. Manuals
  2. Brands
  3. Norlase Manuals
  4. Medical Equipment
  5. Leaf
  6. Operator's manual

Norlase Leaf Operator's Manual

Green laser photocoagulator
Hide thumbs
Table of Contents

Advertisement

Quick Links

Download this manual
Green Laser Photocoagulator
Operator Manual
Norlase ApS
Brydehusvej 13
Ballerup 2750 DENMARK
Phone: +45 93 97 74 72
®
™
Norlase Inc. USA
895 Hurlingame Ave
Redwood City, CA 94063
Phone: +1.650.489.0083
Toll Free 833.667.5273 USA Only
USA

Advertisement

Table of Contents
loading

Related Manuals for Norlase Leaf

Summary of Contents for Norlase Leaf

  • Page 1 ® ™ Green Laser Photocoagulator 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.

  • Page 3: Table Of Contents

    INSPECTION AND CLEANING ..............................35 ............................35 LEANING THE ONSOLE XTERNAL URFACES ..............................36 LEANING THE ONTROL ANEL CREEN ................................36 NSPECTING THE OWER UPPLY NORLASE LEAF SPECIFICATIONS..............................37 Leaf User Manual P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 3 of 85...
  • Page 4 ARRANTY HIPMENTS ETURNS DJUSTMENTS ............................83 ECONTAMINATION OF ETURNED QUIPMENT US T ..............................83 ECHNICAL ERVICE NFORMATION ............................... 84 ECONTAMINATION ERTIFICATION WEEE D ....................................85 ISPOSAL Leaf User Manual P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 4 of 85...

  • Page 5: Indications For Use / Intended Use

    Introduction The Norlase Leaf is a monolithic green laser system/delivery device designed to be user-detachable from the Slit Lamp. Leaf is controlled via a wireless tablet user interface utilizing touch screen or voice control of parameters. The system may be used for all standard single shot photocoagulation procedures listed in the indications for use section of this manual.

  • Page 6: Package Contents

    Houses the key switch, emergency laser stop button, foot switch and power inputs, green treatment laser, red aiming laser, Spot size adjusting optics and control electronics. Recommended connectivity to Haag-Streit style slit lamps. Check with Norlase or your authorized distributor for complete list of compatible slit lamps.

  • Page 7: 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 Leaf photocoagulator. The use of any unauthorized applications may affect the performance of the system and is prohibited.

  • Page 8: Footswitch

    USB cables provided in the package. No other items, devices or cables must be inserted into the USB connectors. Doing so risks unauthorised access to the system. Leaf User Manual P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 8 of 85...

  • Page 9: System Preparation And Setup

    Optimal system performance and viewing is achieved in low ambient light conditions. Norlase Leaf power supply is equipped with a 3-wire AC power cord. When selecting the location for system installation, ensure that the AC wall power outlet is correctly grounded.

  • Page 10: Connecting The System Components

    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 Leaf User Manual P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 10 of 85...
  • Page 11 If using an external door interlock, a qualified electrical professional must install the external switch, and the total length of the cable should not exceed 5 m (16 ft). Leaf User Manual P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 11 of 85...

  • Page 12: Attaching The Norlase Laser To A Slit Lamp

    Attaching the Norlase Laser to a Slit Lamp The Norlase Leaf Laser System is designed to attach to the tonometer mount of Haag Streit (top illumination) style slit lamps. Consult Norlase technical support or your local Norlase distributor for compatibility information.
  • Page 13 3. Make sure the plate is completely seated onto the tonometer mount and tighten locking screw. 4. Swing the illumination tower back in behind the laser. Tonometer mount locking screw Leaf User Manual P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 13 of 85...

  • Page 14: System Start-Up And Shut-Down

    Key Switch OFF Key Switch ON Cable Connections & Key Switch 6. Press and hold the “ON” button of the display tablet until the tablet powers up. Leaf User Manual P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 14 of 85...
  • Page 15 Power Button 7. The laser status LED will illuminate green when the tablet and laser have established a connection. Status LED Leaf User Manual P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 15 of 85...

  • Page 16: Shutting Down The System

    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. Leaf User Manual P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 16 of 85...

  • Page 17: Home Screen

    Home Screen Leaf User Manual P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 17 of 85...

  • Page 18: 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. Leaf User Manual P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 18 of 85...

  • Page 19: 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. Leaf User Manual P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 19 of 85...

  • Page 20: Changing The Spot Size Diameter

    Changing the Spot Size Diameter The Norlase Leaf is equipped with an electronic spot size adjustment selected from the User Interface. To change the delivered spot size: 1. Select the User Interface toggle to enable the Spot Size popup 2. To change spot size, lightly press your finger along the active area of the arc and slide until the desired setting is reached.
  • Page 21 The energy density of any given spot is displayed in the “Status Summary” at the bottom left of the User Interface for easy reference. Leaf User Manual P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 21 of 85...

  • Page 22: 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 system will audibly call back the requested command and any parameter setting that has been changed.

  • Page 23: List Of Voice Commands

    List of Voice Commands: ♬ indicates audible tone heard after “OK Norlase” XXX Indicates Current value will be read Audible Full Command Command System Action Response “OK Norlase” ♬ Places the system into Enter Treat Treat Mode Selected the “Ready” Mode “Enter Treat”...

  • Page 24: Voice Control Settings

    2. If selecting the voice control does not highlight the green circle and the icon displays , voice control is not available on this system. Call Norlase or an authorized Distributor to purchase this feature. Leaf User Manual...

  • Page 25: Tablet Volume Control

    The tablet audio volume may be adjusted by using the slider control under the icon 1. Touch the icon to display the slider. 2. Adjust the slider to the desired volume level. Leaf User Manual P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 25 of 85...

  • Page 26: 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 Leaf User Manual P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 26 of 85...

  • Page 27: Using Μsec Mode

    Most clinical protocols suggest titration in normal CW mode to set the baseline, and then switch to the µSec treatment to deliver photo-thermal stimulation to tissue. The Leaf photocoagulator is designed to utilize this recommended treatment sequence.
  • Page 28 Power Factor will be adjusted accordingly. Titration Power Titration Duration 6. Begin treatment in the desired area. 7. Press “END” when treatment is complete. Leaf User Manual P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 28 of 85...

  • Page 29: Setting A Custom Μsec Duty Cycle

    5. Adjust the Power Factor and Duration Envelope to desired levels and press “Apply”. 6. Begin treatment in the desired area. 7. Press “END” when treatment is complete. Leaf User Manual P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 29 of 85...

  • Page 30: 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. Leaf User Manual P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 30 of 85...
  • Page 31 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. Leaf User Manual P/N: 97-4000, Revision 08, Release date: 2020-11-10...

  • Page 32: Settings Tab

    The information provided are the total number of pulses in parenthesis next to the identifying treatment and then the number of pulses for each Power, Duration, Interval and spot size change made during the procedure. Leaf User Manual P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 32 of 85...

  • Page 33: Aligning The Laser To The Slit Lamp Visual And Illumination Axis

    5. After the aiming beam is centered, adjust the laser spot size on the tablet to 50 microns and adjust the Z axis focus to the smallest spot possible. The laser is now parfocal with the visual and illumination axis. Adjust Z Leaf User Manual P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 33 of 85...

  • Page 34: Intraoperative Instructions

    The pulse count will retain the same pulse count of the prior treatment and can only be reset by pressing the Reset button on the user interface. Leaf User Manual P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 34 of 85...

  • Page 35: Between Patient Treatments

    Inspection and Cleaning The following procedures can be performed by the user to ensure proper performance of Norlase Leaf. During inspection and cleaning, the system shall be disconnected from the AC wall power outlet. Cleaning the Console External Surfaces Clean the external surfaces of the console daily, after use.

  • Page 36: Cleaning The Control Panel Screen

    Inspecting the Power Supply Inspect the Power Supply cabling for any cuts or abrasions to the cabling. If any noticeable trauma has occurred, please contact Norlase Technical Support or your authorized Distributor to replace the power supply. The power supply must be replaced with a factory authorized replacement or damage to the laser system may occur.

  • Page 37: Norlase Leaf Specifications

    Norlase Leaf Specifications [Specifications are subject to change without notice.] Treatment Beam Type Semiconductor Laser Wavelength 520 nm 0 – 1500 mW ; 0-1250mW @ 50 micron spot size Power output Duty cycle 100% 50 µSec – 1000 ms Pulse durations...
  • Page 38 Therapeutic Laser Equipment International Safety Requirements for Medical Electrical EN/IEC 60601-1 Equipment EN/IEC 60601-1-2 EMC Requirements for Medical Electrical Equipment EN/IEC 60825-1 Safety of laser products Leaf User Manual P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 38 of 85...
  • Page 39 Standard commercial shipping altitude Non-operating -10° to +55°C (14° to 131°F) temperature Maximum humidity 85% (non-condensing) Other Expected Service Life Minimum seven years from Customer Installation Leaf User Manual P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 39 of 85...
  • Page 40 Laser Safety Eyewear USA (ANSI) Minimum OD of 5 at 520 nm per ANSI Z136.1 D LB6 at 520 nm per EN 207 Personal Eye EU (CE) Protection Leaf User Manual P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 40 of 85...

  • Page 41: Troubleshooting Guide

    Troubleshooting Guide If the instrument fails to operate properly, this troubleshooting guide will help you to locate and correct the malfunction. Should a major malfunction occur, contact Norlase Technical Support or your authorized Distributor. Please note any messages or Error Codes the system may display.
  • Page 42 Internal system error. Suggestion: Turn key switch to OFF position, wait at least one minute and then turn to ON position. If system fails to start, contact service. Leaf User Manual P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 42 of 85...
  • Page 43 Remote interlock has been activated and has disabled system. Suggestion: Ensure the action that activated remote interlock has ceased and proceed. Probable Cause: Footswitch and/or footswitch cable damaged. Suggestion: Inspect for damage. Leaf User Manual P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 43 of 85...
  • Page 44 Probable Cause: Unauthorised access to system Suggestion: Turn Key OFF, then ON on laser console and reboot tablet. If problem persists, contact Norlase customer service Probable Cause: Electronic component failure Suggestion: Turn Key OFF, then ON on laser console and reboot tablet.

  • Page 45: Pairing An Unpaired Tablet With Laser Console

    Pairing an Unpaired Tablet with Laser Console A user interface tablet 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. Obtain the Type C USB to Micro USB cable supplied with the tablet.

  • Page 46: 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 system to immediately go to a safe state. Clearable Error indicates a problem with the system that requires that the system be put into a safe state until the error is acknowledged by the user or returns within specification.
  • Page 47 Call service if error persists. Turn Key OFF, then ON & Characteristic read 2-13 Bonding failure reboot tablet empty queue Call service if error persists. Leaf User Manual P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 47 of 85...
  • Page 48 Call service if error persists. Verify hardware is powered Failed descriptor 2-31 Bonding failure on and within range write Sync Call service if error persists. Leaf User Manual P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 48 of 85...
  • Page 49 Call service if error persists. Turn Key OFF, then ON & Cable 3-11 Received READ reboot tablet communication error Call service if error persists. Leaf User Manual P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 49 of 85...
  • Page 50 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. Leaf User Manual P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 50 of 85...
  • Page 51 Verify bonding cable is connected Failed to open serial Laser Error Turn Key OFF, then ON & connection reboot tablet Call service if error persists. Leaf User Manual P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 51 of 85...
  • Page 52 Selected power factor resulted in a power higher Power Factor Railed Laser Error than the maximum. Power was set to the maximum allowed. Leaf User Manual P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 52 of 85...

  • Page 53: Calibration Check Procedure

    Disclaimer Warning Calibration of the Norlase Leaf is a service procedure to be performed only by a Norlase certified engineer or technician. Measurement or adjustment by anyone other than a Norlase certified engineer or technician voids any existing manufacturer’s warranty on the instrument and can result in serious personal injury.

  • Page 54: System Relocation Instructions

    Consult with Norlase Technical support or your authorized distributor. 6. If there are changes in environmental conditions (temperature or humidity) allow system to acclimate for 4 hours prior to use to prevent condensation.

  • Page 55: 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...

  • Page 56: Laser Safety Eyewear

    Laser Safety Eyewear Laser safety eyewear is routinely required with most lasers. When using Norlase Leaf, the laser safety officer should determine the need for safety eyewear based on the Maximum Permissible Exposure (MPE), Nominal Hazard Zone (NHZ) and the Nominal...
  • Page 57 NHZ depends on the planned procedure and the equipment required to perform that procedure. An eye safety filter is provided with the Norlase Leaf SLA and is required for safe use. Laser safety eyewear is not required by the physician who views the procedure through the slit lamp eyepieces.

  • Page 58: 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 Norlase manufacturer's recommendation and institutional standards.

  • Page 59: Fire Hazard

    Norlase Leaf. The solvents of adhesives and flammable solutions used for cleaning and disinfecting should be allowed to evaporate before the laser system is used.

  • Page 60: Operational Safety

    Do not use wide field contact lenses for macular grid photocoagulation. Wide field lenses will enlarge the spot diameter and alter the Foveal Exclusion Zone ring diameter. Leaf User Manual P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 60 of 85...
  • Page 61 If the aiming beam size appears inappropriate or distorted, do not proceed with treatment. Readjust the slit lamp focus. If the problem persists, contact Norlase service or your authorized Distributor. It is the responsibility of the physician to select the appropriate power and treatment location.

  • Page 62: Additional Safety Considerations

    Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure. Norlase medical devices are solely for use by physicians trained in the operation of laser photocoagulation and associated delivery devices.

  • Page 63: Regulatory Compliance Safety Features

    Regulatory Compliance Safety Features Norlase Leaf 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 system can be activated only with the proper key to operate the master key switch.

  • Page 64: Emergency Stop

    Location and description of caution, warning and system labels are described on the following pages. Leaf User Manual P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 64 of 85...

  • Page 65: Console Labels

    Emergency Stop Laser warning label includes: • Laser Emission Warning • Wavelength • Power • Laser Class • Standard reference Laser Emission Warning Laser Aperture Label Leaf User Manual P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 65 of 85...
  • Page 66 Keep dry symbol CE Mark Barcode on silver label: Unique Device Identification (UDI) is a system used to mark and identify medical devices within the healthcare supply chain Leaf User Manual P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 66 of 85...
  • Page 67 Danger label includes: • Laser Emission Warning • Wavelength • Power • Laser Class USB Connections Remote Door Interlock Connection Footswitch Connection Leaf User Manual P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 67 of 85...

  • Page 68: Slit Lamp Adapter (Sla) Labels

    Slit Lamp Adapter (SLA) Labels Laser Aperture Label Leaf User Manual P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 68 of 85...

  • Page 69: Additional Labels

    Additional Labels Foot Switch Label Control Tablet Label Power Supply Label _____________________ “XX” denotes the version number. Leaf User Manual P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 69 of 85...

  • Page 70: Electromagnetic Compatibility

    EMC information provided in this manual. NOTE Norlase Leaf laser systems have been designed and tested to comply with EN/IEC 60601-1-2:2015 requirements for EMC with other devices. Consult the tables below for guidance in placing the laser system.
  • Page 71 Guidance and Manufacturer's Declaration: Electromagnetic Immunity Norlase Leaf is intended for use in the electromagnetic environment specified below. The customer or the user of the laser system should ensure that it is used in such an environment. Immunity Test IEC 60601 Test...
  • Page 72 Guidance and Manufacturer's Declaration: Electromagnetic Immunity Norlase Leaf is intended for use in the electromagnetic environment specified below. The customer or the user of the laser system should ensure that it is used in such an environment. Immunity Test IEC 60601 Test...
  • Page 73 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and Norlase Leaf Norlase Leaf is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the laser system can help prevent electromagnetic interference by...

  • Page 74: Indications For Use

    Indications for Use The Norlase Leaf Laser System 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 Operators Manual.

  • Page 75: Usage Precautions (During Use)

    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. o It is normal to see orange/yellow fluorescence from the target site, especially when using high power levels.

  • Page 76: Usage Precautions (After Use)

    • Significant corneal edema or a diminished aqueous clarity obscuring visualization of the anterior chamber angle • Glaucoma secondary to active uveitis Leaf User Manual P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 76 of 85...

  • Page 77: Precautions In Patient Selection

    User to adjust the power appropriately. The following WARNING appears: Leaf User Manual P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 77 of 85...
  • Page 78 • Photocoagulation of pigmented tissue The Norlase Leaf 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...

  • Page 79: Adverse Effects And Complications

    Schlemm’s canal to the site of laser impact. This is easily stopped by increasing the pressure on the gonio lens on the cornea or by coagulating the bleeding site by application of a laser burn. Leaf User Manual P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 79 of 85...

  • Page 80: Rarely, Severe Iritis May Occur, Related To Either An Unusual Patient Response Or Improper Spot Location

    If the system Interval setting is used, longer Interval settings will aid in proper tissue targeting and allow adequate physician response time in case of patient movement. Leaf User Manual P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 80 of 85...

  • Page 81: Ophthalmology References

    Laser 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 Leaf User Manual P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 81 of 85...

  • Page 82: Warranty Information

    The liability of Norlase under valid warranty claims is limited to repair or replacement at Norlase’ facility or purchaser's place of business (or, if not practicable, a refund of the purchase price, all at the option of Norlase).

  • Page 83: Decontamination Of Returned Equipment

    Decontamination of Returned Equipment To comply with United States postal and transportation law, equipment 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.

  • Page 84: Decontamination Certification

    Hospital Disinfectant and is clean and free from biohazards, including – but not limited – human or animal blood, tissue or tissue fluids or components thereof. The undersigned also agrees to reimburse Norlase for any costs incurred in decontaminating the enclosed equipment, in the event said item is received by Norlase in a contaminated condition.

  • Page 85: Weee Disposal

    WEEE Disposal Contact your local representative for disposal information. Leaf User Manual P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 85 of 85...

Table of Contents