Avedro KXL System Operator's Manual
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Avedro KXL System Operator's Manual

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Avedro, Inc.
KXL® System
Operator's Manual
Copyright 2023. Avedro, a Glaukos Company. All Rights Reserved
Printed in U.S.A.
KXL System Operator's Manual
ML-00002 Rev 3

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Summary of Contents for Avedro KXL System

  • Page 1 Avedro, Inc. KXL® System Operator’s Manual Copyright 2023. Avedro, a Glaukos Company. All Rights Reserved Printed in U.S.A. KXL System Operator’s Manual ML-00002 Rev 3...
  • Page 2 United States and worldwide. “KXL®” and the Avedro logo design are registered trademarks or trademarks of Avedro, Inc. All software and documentation are subject to Avedro, Inc. copyrights. Avedro is a wholly owned subsidiary of GLAUKOS Corporation. All rights reserved 2023.

  • Page 3: Table Of Contents

    FCC Compliance Notice ......................6 Introduction ............................8 System Overview ........................8 2.1.1 Major Components ......................9 System Operation ........................... 12 Charging the KXL System Battery ................... 12 Touchpad/Keyboard Use ......................13 UV Dose ..........................14 3.3.1 Continuous Mode ....................... 14 3.3.2...
  • Page 4 3.16 Pausing or Canceling a Treatment ..................29 3.17 Powering Down the System ....................30 3.18 Checking KXL System Battery Function after Storage ............31 3.19 Using the Device Settings Menu ..................... 32 3.19.1 Advanced Settings ....................32 3.19.2 Editing System Language ..................32 3.19.3...
  • Page 5 Table of Figures Figure 2-1. Overview Illustration of KXL System ....................9 Figure 2-2. System Illustrations with Callouts ....................10 Figure 2-3. Wireless Remote ......................... 10 Figure 2-4. KXL Label............................11 Figure 2-5. UV Emitting Label ........................11 Figure 2-6. Alignment Laser Classification Label ................... 11 Figure 3-1.
  • Page 6 Figure 3-28. Power Off ..........................30 Figure 3-29. Power Off Position........................30 Figure 3-30. KXL System Plug ......................... 31 Figure 3-31. KXL System Battery Status Indicator ..................31 Figure 3-32. Device Settings Menu ........................ 32 Figure 3-33. Edit System Language ........................ 32 Figure 3-34.

  • Page 7: Foreword

    Intended Use / Indications for Use The KXL System delivers a uniform, metered dose of UVA light to a targeted treatment area for the intended use of illuminating the cornea during corneal cross-linking procedures stabilizing cornea which have been weakened by disease or by refractive surgery.

  • Page 8: User Operation Assistance Statement

    KXL System Operator’s Manual | Page 2 User Operation Assistance Statement Should you experience any difficulty in running your KXL System, please contact your local Avedro-authorized representative. Contraindications, Warnings and Cautions 1.1.1 Contraindications This section describes situations in which the device should not be used because the risk of use clearly outweighs any possible benefit.
  • Page 9 Avedro KXL System. For Equipment Classifications, please refer to Chapter 5.0 Equipment Classifications. WARNING: WARNING: Any repair or service must be carried out by Avedro trained personnel only. WARNING: Do NOT modify this equipment without authorization of the manufacturer.
  • Page 10 WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30cm (12 inches) to any part of the Avedro KXL system, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
  • Page 11 AVEDRO | 5 of 52 WARNING: System shall not be serviced or maintained while in use with a patient. WARNING: No modification of this equipment is allowed. WARNING: Do not use a damaged or malfunctioning device. Use of such devices may harm the user and/or patient.

  • Page 12: Radiation Safety Warnings

    System not be moved during the treatment procedure. CAUTION: The KXL System is a medical device. It may be operated, therefore, only in health care facilities or medical areas under the supervision of medically trained personnel.
  • Page 13 Consult Avedro Customer Service for help. Properly shielded and grounded cables and connectors must be used in order to meet FCC emission limits. Proper cables and connectors are available from Avedro. Avedro is not responsible for any radio or television interference caused by unauthorized changes or modifications to this equipment.

  • Page 14: Introduction

    Power, and UV Pulse Cycle Times) are selected through the user interface touchscreen computer. The KXL System is used in conjunction with a Riboflavin solution and an RFID activation card. NOTE: The depictions of the KXL System and user interface screenshots included in this manual are for demonstration purposes only.

  • Page 15: Major Components

    AVEDRO | 9 of 52 2.1.1 Major Components The major components of the KXL System include the following: • Optics Head with UV source • KXL console with user interface • Wireless remote control (with replaceable batteries) • KXL Accelerated Crosslinking Treatment Kit (disposable supplied separately) Figure 2-1.

  • Page 16: Figure 2-2. System Illustrations With Callouts

    KXL System Operator’s Manual | Page 10 Figure 2-2. System Illustrations with Callouts Figure 2-3. Wireless Remote ML-00002 Rev 3...

  • Page 17: Figure 2-4. Kxl Label

    AVEDRO | 11 of 52 Figure 2-4. KXL Label Figure 2-5. UV Emitting Label Figure 2-6. Alignment Laser Classification Label ML-00002 Rev 3...

  • Page 18: System Operation

    NOTE: If the battery does not appear to be charging or retaining its charge, please contact your local Avedro Service Representative. NOTE: The KXL System prohibits a treatment if there is insufficient battery power to perform a treatment. (See Chapter 4 Maintenance/Service for more information on troubleshooting battery problems.)

  • Page 19: Touchpad/Keyboard Use

    AVEDRO | 13 of 52 Touchpad/Keyboard Use The table below identifies and describes important touchpad keys and icons unique to KXL System operation. Chapter 2 identifies and describes the System’s major components. Touchpad Key Icon Description/Function Power Off button Turns OFF electric power to the (Initial screen) internal computer.

  • Page 20: Uv Dose

    1.0 – 4.0 seconds Please reference Riboflavin Instructions for Use (IFU) for formulation information. Preparing the System • Position the KXL System adjacent to the treatment table or chair. Lock the casters to secure the device’s position. ML-00002 Rev 3...

  • Page 21: Important Steps Before Turning On The System

    4.9 for cleaning instructions. Important Steps Before Turning on the System • The user is responsible for assuring that the KXL System is functioning properly and is in good working condition before starting a treatment. • To ensure the System is functioning properly, consider the following...

  • Page 22: Set Riboflavin Induction Period

    KXL System Operator’s Manual | Page 16 Figure 3-2. Startup Screen • To begin patient treatment, press the Start New Treatment button. • Please see Section 3.17 for Power Down sequence instructions. NOTE: If there is a start-up error, please note any error messages and contact your distributor or Customer Service immediately.

  • Page 23: Select Uv Treatment Mode

    AVEDRO | 17 of 52 Select UV Treatment Mode There are two UV treatment modes available, Continuous and Pulsed. • Continuous Mode: The UV output is constant for the duration of the UV treatment. • Pulsed Mode: The UV output turns ON and OFF at user selected intervals.

  • Page 24: Pulsed Uv Treatment Mode

    KXL System Operator’s Manual | Page 18 Figure 3-5. Continuous UV Treatment Parameters Screen • Confirm the specified treatment parameters by pressing the Checkmark. If the treatment parameters are not correct, press the X and then re-enter the desired treatment parameters.

  • Page 25: Figure 3-8. Pulsed Uv Treatment Parameters Screen

    AVEDRO | 19 of 52 • Enter the desired UV treatment parameters: Total Energy: User may select UV Energy in 0.1 J increments. Range is controlled by the RFID card. UV Power: 15 mW/cm – 45 mW/cm NOTE: UV irradiation time is displayed in the orange box.

  • Page 26: Starting Treatment

    KXL System Operator’s Manual | Page 20 • Confirm the specified treatment parameters by pressing the Checkmark. If the treatment parameters are not correct press the X and then re-enter the desired treatment parameters. Figure 3-10. Confirm Pulsed UV Treatment Parameters Screen Starting Treatment •...

  • Page 27: Multi-Use Disposables

    AVEDRO | 21 of 52 3.1.6 Multi-use Disposables • Once a multi-use activation card has been scanned, the display will show the number of treatments remaining on the card. Figure 3-12. Treatments Remaining Figure 3-13. Final Treatment ML-00002 Rev 3...

  • Page 28: Rfid Card Controlled Limits

    KXL System Operator’s Manual | Page 22 Figure 3-14. No Treatments Remaining 3.1.7 RFID Card Controlled Limits • If the user has previously programmed an UV Energy range that is outside the allowable value(s) controlled by the RFID card, an Invalid Treatment Parameters message will appear.

  • Page 29: Preparing The Patient

    Disconnection sync (after procedure) Blinking constantly, twice per second Replace remote batteries immediately (2 AAA) NOTE: The KXL System performs an internal self-test prior to each treatment to verify proper UVA calibration. • The internal self-test uses a redundant set of optical sensors to ensure that accurate levels of UVA will be delivered for each treatment.

  • Page 30: Alignment Of The Device

    KXL System Operator’s Manual | Page 24 CAUTION: Riboflavin (vitamin B2) is not a part of the KXL System described in this manual. For details of component use, please refer to the component’s Directions for Use. Figure 3-17. Prepare Patient Screen NOTE: Once the Riboflavin is applied to the eye, Start the induction by pressing the “Riboflavin Applied: Start Timer”...

  • Page 31: Figure 3-18. Align Crosshairs During Induction

    AVEDRO | 25 of 52 Figure 3-18. Align Crosshairs During Induction Figure 3-19. Remote Functions Figure 3-20. Red Crosshairs X & Y Axes, Red Crosshairs Z Axis Alignment ML-00002 Rev 3...

  • Page 32: Initiating Treatment

    Figure 3-21. Induction Complete WARNING: Start treatments only after photosensitizer is applied. WARNING: Make sure that the KXL System and the patient’s table or chair are secured and not moved after alignment and during treatment. CAUTION: UV light is emitted when the Avedro logo on the optical head changes color from blue to green.

  • Page 33: Stopping A Treatment

    AVEDRO | 27 of 52 Figure 3-22. Treatment Screen NOTE: When using Pulsed Treatment mode, UVA light will not be visible during the OFF periods. The User Interface will not change to “UV is OFF” during these cycles. • The patient should attempt to fixate on the red X & Y alignment crosshair throughout the treatment.

  • Page 34: Treatment Complete

    KXL System Operator’s Manual | Page 28 Treatment Complete • At the completion of a treatment, the Total Treatment Parameters will be displayed, and the screen will show “Treatment Completed.” Figure 3-24. Treatment Complete Screen • Press “Start New Treatment” to exit treatment and / or start a new treatment.

  • Page 35: Pausing Or Canceling A Treatment

    AVEDRO | 29 of 52 Pausing or Canceling a Treatment Treatment may be paused at the discretion of the user. If a session is canceled, the screen displays with “Confirm Cancel Session.” Figure 3-25. Confirm Cancel Session Screen • To cancel a session, press “Cancel Session.”...

  • Page 36: Powering Down The System

    The screen displays “Partial Treatment Information.” Figure 3-27. Partial Treatment Information Powering Down the System NOTE: It is recommended that the KXL System be plugged into an electrical outlet when not in use or when stored. Figure 3-28. Power Off •...

  • Page 37: Checking Kxl System Battery Function After Storage

    Checking KXL System Battery Function after Storage If the KXL System has not been plugged into an AC outlet or in use for a period of 3 months or more, proceed as follows to determine the health of the KXL System battery.

  • Page 38: Using The Device Settings Menu

    Figure 3-32. Device Settings Menu 3.1.9 Advanced Settings • Advanced Settings are only available to Avedro and Service personnel with a KXL Advanced Settings access card. If selected, the user will be prompted to scan an access card. 3.1.10 Editing System Language •...

  • Page 39: Editing Alignment Crosshairs Intensity

    AVEDRO | 33 of 52 3.1.11 Editing Alignment Crosshairs Intensity • The Alignment Crosshairs Intensity option allows a user to edit the brightness of the alignment crosshairs. • Select the Edit Alignment Crosshairs Intensity button on the Device Settings menu.

  • Page 40: Figure 3-36. Data Transfer To Usb

    KXL System Operator’s Manual | Page 34 • Select the Copy Treatment Data to USB button on the Device Settings menu. Figure 3-36. Data Transfer to USB • Insert a USB device to a USB port and then press the Copy treatment data to USB button.

  • Page 41: Editing Default Treatment Parameters

    AVEDRO | 35 of 52 3.1.14 Editing Default Treatment Parameters • The Edit Default Treatment Parameters option allows a user to set the default treatment parameters that are displayed on entry to the Set Induction Time and Set UV Parameters screens.

  • Page 42: Maintenance / Service

    Customer Maintenance • In general, there is no customer maintenance required for the KXL System. All technical maintenance or service will be performed by a qualified service representative while under service contract. If you have trouble with your system, refer to the troubleshooting section below or call your local Avedro Representative.

  • Page 43: Per Patient Disposables

    Per Patient Disposables can be ordered from Avedro or your Avedro- authorized distributor. Use only Avedro products or Avedro-approved products with your KXL System. Avedro shall not be liable for damage to or malfunction of the system, which it deems, was caused by the use of unauthorized materials.

  • Page 44: Internal Rechargeable Battery

    4.1.2 Internal Rechargeable Battery • The KXL System is supplied with a rechargeable battery, if the system does not appear to be turning on, ensure that the battery is charged by plugging it into an outlet and checking the charging indicator on the column of the system.

  • Page 45: Articulating Arm Adjustment

    AVEDRO | 39 of 52 • Check the beam aperture routinely prior to treatment. • Use special camera lens wipes or compressed air to remove dust and particles from the glass surface of the aperture. Articulating Arm Adjustment If the articulating arm does not hold the Optical Head in a fixed vertical position, follow the steps outlined below to counterbalance the articulating arm.

  • Page 46: Figure 4-4. With Arm Raised, Tighten Set Screw (A)

    KXL System Operator’s Manual | Page 40 In some instances, further counterbalance adjustments are needed to allow the arm’s instant height adjustment function to work properly. If your arm is not staying in position after performing the above steps, perform the following steps: NOTE: Do not over tighten screws.

  • Page 47: Figure 4-6. Summary Of Further Counterbalance Adjustments

    AVEDRO | 41 of 52 Figure 4-6. Summary of Further Counterbalance Adjustments • If you continue to have issues with the articulating arm after following the above steps, contact your local Avedro service representative. ML-00002 Rev 3...

  • Page 48: Moving The System

    • The KXL is designed as a movable system within an office environment. If it ever proves necessary to transport or ship the KXL System, for any reason, contact your local Avedro representative. Packing and transporting the system should be performed only by Avedro trained and authorized personnel.

  • Page 49: Software

    Software • Should the software become corrupted and fail to work correctly at some point, call your local Avedro service representative. Software updates will only be carried out by Avedro service representatives. Identifying Risks Associated with Disposing of Waste Products •...

  • Page 50: Equipment Classification

    KXL System Operator’s Manual | Page 44 5 Equipment Classification Equipment Classification According to IEC60601-1 Medical Device Electrical Standard • Protection against electrical shock Class 1 (external electrical power source) Internally powered equipment (internal battery operation) • Degree of protection against electric shock...

  • Page 51: Emc Guidance

    AVEDRO | 45 of 52 EMC Guidance System requires special precautions regarding electromagnetic compatibility (EMC). Installation and use should be carried out according to the EMC information provided in this manual. Portable and mobile RF communications equipment may affect the KXL System.
  • Page 52 KXL System Operator’s Manual | Page 46 Guidance and manufacturer’s declaration — electromagnetic immunity The KXL UV Illumination System is intended for use in the electromagnetic environment specified below. The customer or the user of the KXL UV Illumination System should assure that it is used in such an environment.
  • Page 53 AVEDRO | 47 of 52 Table 5-2. Electromagnetic Immunity Guidance and manufacturer’s declaration electromagnetic immunity — The KXL UV Illumination System is intended for use in the electromagnetic environment specified below. The customer or the user of the KXL UV Illumination System should assure that it is used in such an environment.
  • Page 54 KXL UV Illumination System The KXL System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the KXL System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the KXL UV Illumination System as recommended below, according to the maximum output power of the communications equipment.

  • Page 55: Rf Transmitters

    AVEDRO | 49 of 52 RF Transmitters The KXL System contains an RFID function which transmits and receives at the 13.56 MHz frequency. This functionality may be interfered with by other equipment, even if that other equipment complies with CISPR emission requirements.

  • Page 56: Symbol Library

    KXL System Operator’s Manual | Page 50 6 Symbol Library Text Symbol Symbol Illustration Definition 1. No AP symbol in presence of Danger, Risk of Explosion. Not for flammable anesthetics 2. AC symbol Alternating current 3. “I” in a book...
  • Page 57 AVEDRO | 51 of 52 Text Symbol Symbol Illustration Definition 14. Water drop in a box Humidity limits (percentages below symbol are the acceptable range for humidity) 15. Temperature limits Temperature shipment limits 16. MR crossed in a circle MR Unsafe – Keep away from...

  • Page 58: Specifications

    KXL System Operator’s Manual | Page 52 7 Specifications Specification Description Electrical Battery Powered: 12V 35 Ah SLA Line voltages 100 – 240 volts AC Current: 2A – 1A Single Phase RMS, 50/60 Hz Remote 2x AAA batteries User accessible Fuses...

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