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

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Operator's Manual
ML-00002
Copyright 2012
Printed in U.S.A.
Avedro, Inc.
KXL System
Revision G
All Rights Reserved

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Summary of Contents for Avedro KXL

  • Page 1 Avedro, Inc. KXL System Operator’s Manual ML-00002 Revision G Copyright 2012 All Rights Reserved Printed in U.S.A.
  • Page 2 Patents, Trademarks, Copyrights The KXL System may be covered by one or more patent applications issued or pending in the United States and worldwide. “KXL” and the Avedro logo design are registered trademarks or trademarks of Avedro, Inc. All software and documentation is subject to Avedro, Inc. copyrights.

  • Page 3: Table Of Contents

    Chapter: 2 Introduction ....................2-1 System Overview ................... 2-1 2.1.1 Major Components ................2-2 Chapter: 3 System Operation ..................3-1 Charging the KXL Battery ................3-1 Touchpad/Keyboard Use ................3-1 UV Dose......................3-3 Preparing the System ..................3-3 Important Steps before Turning on the System ..........3-3 Powering Up the System ................
  • Page 4 Identifying Risks Associated with Disposing of Waste Products ....4-4 4.16 Performing a Visible Check ................4-4 Chapter: 5 Equipment Classification ................. 5-1 Chapter: 6 Symbol Library ..................6-1 Chapter: 7 Specifications ..................... 7-1 KXL System Operator’s Manual, Rev G...
  • Page 5 Figure 3-19. Partial Treatment Information ..............3-15 Figure 3-20. Power Off ....................3-16 Figure 3-21. Power Off Position ..................3-17 Figure 3-22. KXL System Plug ..................3-17 Figure 3-23. Device Settings Menu ................3-18 Figure 3-24. Edit Alignment Crosshairs Intensity ............3-19 Figure 3-25.
  • Page 6 This page is left blank intentionally. KXL System Operator’s Manual, Rev G...

  • Page 7: Chapter: 1 Forward

    1.2 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 crosslinking procedures stabilizing cornea which have been weakened by disease or by refractive surgery.

  • Page 8: Contraindications, Warnings And Cautions

    UVA exposure do not remove any fixed panels. Ensure that all service to the system, beyond what is described in this manual, including to the rechargeable battery, is performed only by qualified Avedro service personnel. KXL System Operator’s Manual, Rev G...

  • Page 9: Patient Safety

    It is imperative that the table or patient’s chair or the 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 10: Additional Safety Considerations

    Chapter 1: Forward 1.8 Additional Safety Considerations UV irradiance of the KXL System is calibrated by the manufacturer and must be checked annually. Any modification of the system's external light beam by means of optical elements is strictly prohibited. Plastic instrumentation such as speculums or eye shields may be damaged when impacted by the UV beam, possibly resulting in product degradation.

  • Page 11: Chapter: 2 Introduction

    The KXL is a portable system with an articulating arm to allow movement of the system for alignment of the UV Beam to the patient’s cornea. An internal battery powers the system; the battery is recharged by a system internal charger from any standard AC outlet.

  • Page 12: Major Components

    Chapter 2: Introduction 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 13: Figure 2-2. System Illustrations With Callouts

    Chapter 2: Introduction Figure 2-2. System Illustrations with Callouts Figure 2-3. Wireless Remote KXL System Operator’s Manual, Rev G...

  • Page 14: Figure 2-4. Kxl Label

    Chapter 2: Introduction Figure 2-4. KXL Label Figure 2-5. UV emitting Label Figure 2-6. Laser Classification Label KXL System Operator’s Manual, Rev G...

  • Page 15: Chapter: 3 System Operation

    KXL should be connected to grounded supply mains to allow charging of the battery pack. The change of the battery is identified by a light located on the column of the KXL, the following describes the battery charge.
  • Page 16 (Confirm Cancel Treatment screen. Session screen) Return button Returns to the Device (various Device Settings menu. Settings screen) CAUTION: Only qualified and experienced personnel shall operate the KXL System. KXL System Operator’s Manual, Rev G...

  • Page 17: Uv Dose

    3.6 Powering Up the System Turn ON the single power switch on the front of the KXL console. This switch turns on all the system components. The KXL System begins a power-up sequence, loading the operating system and all configuration and reference files.

  • Page 18: Setting Treatment Settings

    When finished entering parameters, press the Checkmark button. Figure 3-2. Induction Period Screen NOTE: Default treatment parameters will auto-populate fields but are adjustable. Defaults settings can be changed (see section 3.16.5, Editing Default Treatment Parameters Screen). KXL System Operator’s Manual, Rev G...

  • Page 19: Figure 3-3. Treatment Parameters Screen

    When finished entering treatment parameters, press the Checkmark button. Figure 3-4. Confirm 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. KXL System Operator’s Manual, Rev G...

  • Page 20: Starting Treatment

    3.8 Starting Treatment Place the disposable kit (which is unique for each patient) or an activation card on the RFID reader and hold in place until the system emits a beep. Figure 3-5. Reading Disposables KXL System Operator’s Manual, Rev G...

  • Page 21: Single-Use Disposables

    Hold until read is complete and discard tag or activation card. 3.8.2 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 3-7. Treatments Remaining KXL System Operator’s Manual, Rev G...

  • Page 22: Figure 3-8. Final Treatment

    Chapter 3: System Operation Figure 3-8. Final Treatment Figure 3-9. No Treatments Remaining KXL System Operator’s Manual, Rev G...

  • Page 23: Figure 3-10. System Setup Status

    NOTE: If the light on the remote is flashing two times per second the remote’s batteries need to be changed. If the light on the remote is flashing once per second then it is not synchronized. (See chapter 4 Maintenance section of this manual for additional information.) KXL System Operator’s Manual, Rev G...

  • Page 24: Preparing The Patient

    Apply Riboflavin to the area of treatment in accordance with the Riboflavin Instructions for Use (IFU). 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.

  • Page 25: Initiating Treatment

    WARNING: Start treatments only after the photosensitizer is applied. CAUTION: UV light is emitted as long as the blue indication light is ON. WARNING: Make sure that the KXL System and the patient’s table or chair are secured and not moved after alignment and during treatment.

  • Page 26: Monitoring Treatment

    The user may decide to stop or interrupt the treatment. In such case, the UV light can be switched OFF by pushing the Pause button. Figure 3-15. Treatment Paused Screen To cancel or resume treatment press appropriately. See section 3.14 if canceling a session. KXL System Operator’s Manual, Rev G 3-12...

  • Page 27: Treatment Complete

    Apply antibiotic ointment on the cornea and then cover cornea with a bandage contact lens. Remove speculum. Give post-op medication using a regimen similar to after photorefractive keratectomy (PRK): pain medication, steroids, antibiotics. KXL System Operator’s Manual, Rev G 3-13...

  • Page 28: Pausing Or Canceling A Treatment

    Figure 3-17. Initial Confirm Cancel Session Screen To cancel session press Cancel Session. If the session is Paused the screen displays Confirm Cancel Partial Treatment. Figure 3-18. Confirm Cancel Partial Treatment To cancel session press Cancel Session. KXL System Operator’s Manual, Rev G 3-14...

  • Page 29: Figure 3-19. Partial Treatment Information

    Chapter 3: System Operation The screen displays Partial Treatment Information Figure 3-19. Partial Treatment Information KXL System Operator’s Manual, Rev G 3-15...

  • Page 30: Powering Down The System

    Chapter 3: System Operation 3.15 Powering Down the System It is recommended that the KXL System be plugged into an electrical outlet when not in use or when stored. Figure 3-20. Power Off Press the “Power Off” on the touch screen monitor.

  • Page 31: Figure 3-21. Power Off Position

    Chapter 3: System Operation Figure 3-21. Power Off Position Turn the system power switch to the “Off” position. Figure 3-22. KXL System Plug Plug the KXL System in to an electrical outlet until next use. KXL System Operator’s Manual, Rev G 3-17...

  • Page 32: Using The Device Settings Menu

    Chapter 3: System Operation 3.16 Using the Device Settings Menu With the Initialization screen (New Patient Start) displayed, press and hold the KXL on the touch screen. Figure 3-23. Device Settings Menu 3.16.1 Advanced Settings Advanced Settings are only available to Avedro and Service personnel with a KXL Advanced Settings access card.

  • Page 33: Editing Alignment Crosshairs Intensity

    The Edit Volume option allows a user with the appropriate security level to edit the system volume level. Select the Edit Volume button on the Device Settings menu. Figure 3-25. Device Settings Edit Volume KXL System Operator’s Manual, Rev G 3-19...

  • Page 34: Copying Treatment Data To Usb

    The system begins transferring the treatment data and shows a progress bar of the transfer process as shown in the screen below. Once complete press the Return button. The system will return you to the Device Settings menu. KXL System Operator’s Manual, Rev G 3-20...

  • Page 35: Editing Default Treatment Parameters Screen

    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. Figure 3-27. Edit Default Treatment Parameters KXL System Operator’s Manual, Rev G 3-21...
  • Page 36 Chapter 3: System Operation This page is left blank intentionally. KXL System Operator’s Manual, Rev G 3-22...

  • Page 37: Chapter: 4 Maintenance / Service

    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 38: Trouble Shooting

    Avedro Service Representative. 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 39: Directions For Sterilization Or Disinfection

    8 hours contact your local Avedro service representative. 4.7 Directions for Sterilization or Disinfection No components of the KXL System are designed to be sterilized by the operator. External cleaning and disinfection ONLY is recommended. For disinfection purposes, use only isopropyl alcohol spray or preparations.

  • Page 40: Performing Periodic Maintenance

    Calibration by Avedro trained personnel. 4.12 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.

  • Page 41: Chapter: 5 Equipment Classification

    Alignment lasers are Class 1 Laser Product (<0.39 microwatts) According to EN62471 Photobiological safety of lamps and lamp systems o UVA LED is Risk Group 1 According to Annex II.3 of Directive 93/42/EEC as amended by 2007/47/EC o Class IIa KXL System Operator’s Manual, Rev G...
  • Page 42 Chapter 5: Equipment Classification This page is left intentionally blank. KXL System Operator’s Manual, Rev G...

  • Page 43: Chapter: 6 Symbol Library

    10. ! in a Triangle Caution specific warning in operators manual Weight Net Weight (kgs) Gross Weight (kgs) 12. Umbrella with raindrops Keep Dry: Store protected from moisture (symbol is with or without rain drops) KXL System Operator’s Manual, Rev G...
  • Page 44 14. Two up arrows Keep arrows on carton pointing 15. Water drop in a box Humidity limits (percentages below symbol are the acceptable range for humidity) 16. Temperature limits Temperature shipment limits KXL System Operator’s Manual, Rev G...

  • Page 45: Chapter: 7 Specifications

    Transport and Storage Conditions The instrument withstands the following transport and storage conditions without damage or performance deterioration. Ambient temperature -15 to +70 ºC Relative humidity 10% to 100% including condensation Atmospheric pressure 500 to 1060 mbar KXL System Operator’s Manual, Rev G...
  • Page 46 This page is left intentionally blank.

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