Avedro KXL System Operator's Manual
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Summary of Contents for Avedro KXL System
- Page 1 Avedro, Inc. KXL® System Operator’s Manual Copyright 2019. All Rights Reserved. Printed in U.S.A. KXL System Operator’s Manual ML-00006 Rev P...
- 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.
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Page 3: Table Of Contents
System Overview ........................... 6 2.1.1 Major Components ......................7 System Operation ........................10 Charging the KXL System Battery ..................10 Touchpad/Keyboard Use ......................11 UV Dose ............................12 Preparing the System ........................ 12 Important Steps Before Turning on the System ............12 Powering Up the System ...................... - Page 4 Treatment Complete ......................... 25 3.19 Pausing or Canceling a Treatment ..................26 3.20 Powering Down the System ....................28 3.21 Checking KXL System Battery Function after Storage .......... 29 3.22 Using the Device Settings Menu ..................29 3.22.1 Advanced Settings ....................30 3.22.2 Editing Alignment Crosshairs Intensity ............
- Page 5 Table of Figures Figure 2-1. Overview Illustration of KXL System ..................7 Figure 2-2. System Illustrations with Callouts ..................8 Figure 2-3. Wireless Remote ..........................8 Figure 2-4. KXL Label ............................9 Figure 2-5. UV emitting Label .......................... 9 Figure 2-6. Alignment Laser Classification Label ................... 9 Figure 3-1.
- Page 6 Figure 4-7. Edit Default Treatment Parameters ................... 39 Table 5-1. Electromagnetic Emissions ....................... 42 Table 5-2. Electromagnetic Immunity ....................... 43 Table 5-3. Electromagnetic Immunity (continued) ................44 Table 5-4. Recommended Separation Distances ................45 Table 5-5. Highest Emissions ......................... 46 KXL System Operator’s Manual ML-00006 Rev P...
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Page 7: Foreword
AVEDRO | 1 of 49 1 Foreword Intended Use of Manual This manual is designed to serve the operators of the Avedro, Inc. KXL System. All operating instructions, product illustrations, screen graphics, troubleshooting/error messages, and other relevant information are contained in this manual. It is the operator’s responsibility to ensure that all safety instructions in this manual are applied strictly. -
Page 8: Warnings
EMC information provided in this manual. Portable and mobile RF communications equipment can affect medical electrical equipment such as the Avedro KXL System. For Equipment Classifications please refer to Chapter 5.0 Equipment Classifications. WARNING: To avoid the risk of shock this equipment must only be connected to a supply mains with protective earth. - Page 9 WARNING: The USB port can only be used when the system is not in treatment mode, do not connect to the USB during treatment. WARNING: Do not operate the KXL System in the presence of flammable mixtures or anesthetics. WARNING: The remote contains replaceable batteries; if system is not going to be used for an extended period of time remove the batteries.
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Page 10: 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 11: Fcc Compliance Notice
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 12: Introduction
KXL System Operator’s Manual | Page 6 2 Introduction System Overview The KXL System is an electronic medical device which delivers ultraviolet light (365 nm wavelength) in a circular pattern onto the cornea after riboflavin phosphates ophthalmic solution (Photrexa Viscous and/or Photrexa) has been applied. -
Page 13: Major Components
AVEDRO | 7 of 49 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) • Figure 2-1. Overview Illustration of KXL System... -
Page 14: Figure 2-2. System Illustrations With Callouts
KXL System Operator’s Manual | Page 8 Figure 2-2. System Illustrations with Callouts Figure 2-3. Wireless Remote ML-00006 Rev P... -
Page 15: Figure 2-4. Kxl Label
AVEDRO | 9 of 49 Figure 2-4. KXL Label Figure 2-5. UV emitting Label Figure 2-6. Alignment Laser Classification Label ML-00006 Rev P... -
Page 16: 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 perform treatment. -
Page 17: Touchpad/Keyboard Use
AVEDRO | 11 of 49 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 (Initial screen) the internal computer. -
Page 18: Uv Dose
Check glass window of beam aperture for dust and dirt. See • Sections 4.7 and 4.8 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. -
Page 19: Confirm Riboflavin Induction Period
AVEDRO | 13 of 49 Figure 3-1. Power Switch The KXL System begins a power-up sequence, loading the • operating system and all configuration and reference files. Ensure that the System battery status indicator light is green. • Figure 3-2. Startup Screen Please see Section 3.20 for Power Down sequence instructions. -
Page 20: Confirm Uv Treatment
KXL System Operator’s Manual | Page 14 Figure 3-3. Induction Period Screen 3.8 Confirm UV Treatment 3.8.1 Confirm UV Dose Confirm the desired UV treatment parameters by pressing the • Checkmark button: Total Energy (5.4 J/cm UV Power (3 mW/cm NOTE: UV irradiation time is displayed in the orange box. -
Page 21: Starting Treatment
AVEDRO | 15 of 49 Confirm the specified treatment parameters by pressing the • Checkmark. Figure 3-5. Confirm Treatment Parameters Screen 3.9 Starting Treatment Place the activation card on the RFID reader and hold in place • until the system emits a beep. -
Page 22: Single-Use Disposables
KXL System Operator’s Manual | Page 16 3.9.1 Single-use Disposables Hold until read is complete and discard tag or activation card. • 3.9.2 Multi-use Disposables Once a multi-use activation card has been scanned, the display • will show the number of treatments remaining on the card. -
Page 23: Sync Alignment Remote
AVEDRO | 17 of 49 Figure 3-9. No Treatments Remaining 3.9.3 Sync Alignment Remote A Sync Alignment Remote window will appear before • transitioning to the “Prepare for Treatment” window. Press the “S” button on the remote to synchronize the remote •... -
Page 24: Preparing The Patient
KXL System Operator’s Manual | Page 18 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 25: Figure 3-11. Prepare Patient Screen
AVEDRO | 19 of 49 Figure 3-11. Prepare Patient Screen If “Use External Induction Timer” is chosen, the internal KXL • Induction timer will be disabled and user is responsible for monitoring Induction time using an alternative method. If “Start KXL Induction Timer” is chosen, the internal KXL •... -
Page 26: Confirm Riboflavin Absorption
• a treatment. NOTE: For correct alignment when using the Remote, the Avedro logo on optics head should face the user Manually move the Optics head back and forth and left and right • until the red crosshairs are aligned to the center of the pupil. -
Page 27: Figure 3-13. Align Crosshairs During Induction
AVEDRO | 21 of 49 Figure 3-13. Align Crosshairs During Induction Figure 3-14. Remote Functions Figure 3-15. Red Crosshairs X & Y Axes, Red Crosshairs Z Axis Alignment ML-00006 Rev P... -
Page 28: Initiating Treatment
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. ML-00006 Rev P... -
Page 29: Monitoring Treatment
AVEDRO | 23 of 49 3.16 Monitoring Treatment Check continuously that the area of debridement on the cornea • is illuminated with the UV light and adjust as necessary using the wireless remote. Figure 3-17. Treatment Screen The patient should attempt to fixate on the red X & Y alignment •... -
Page 30: Stopping A Treatment
KXL System Operator’s Manual | Page 24 3.17 Stopping a Treatment The treatment stops automatically after the treatment timer • expires. 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. -
Page 31: Treatment Complete
AVEDRO | 25 of 49 3.18 Treatment Complete At the completion of a treatment the Total Treatment • Parameters will be displayed, and the screen will show “Treatment Completed.” Figure 3-20. Treatment Complete Screen Press “Start New Treatment” to exit treatment and / or start a •... -
Page 32: Pausing Or Canceling A Treatment
KXL System Operator’s Manual | Page 26 3.19 Pausing or Canceling a Treatment Treatment may be paused at the discretion of the physician. If a session is canceled the following screen displays with “Confirm Cancel Session.” Figure 3-21. Confirm Cancel Session Screen To cancel a session, press “Cancel Session.”... -
Page 33: Figure 3-23. Partial Treatment Information
AVEDRO | 27 of 49 The screen displays “Partial Treatment Information.” • Figure 3-23. Partial Treatment Information If External Induction Timer was used, the “Total Induction • Period” box will be faded out. Figure 3-24. Partial Treatment Information ML-00006 Rev P... -
Page 34: Powering Down The System
KXL System Operator’s Manual | Page 28 3.20 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 3-25. Power Off Press the “Power Off” on the touch screen monitor. -
Page 35: Checking Kxl System Battery Function After Storage
AVEDRO | 29 of 49 3.21 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 36: Advanced Settings
KXL System Operator’s Manual | Page 30 3.22.1 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. -
Page 37: Copying Treatment Data To Usb
AVEDRO | 31 of 49 3.22.4 Copying Treatment Data to USB WARNING: The USB port can only be used when the system is not in treatment mode. Do not have items connected to the USB during treatment. Select the Copy Treatment Data to USB button on the Device •... -
Page 38: Confirming Treatment Settings
KXL System Operator’s Manual | Page 32 3.22.5 Confirming Treatment Settings The Device Settings: Treatment Parameters option allows a user • to confirm the treatment parameters that are displayed on that system. Figure 3-33. Edit Default Treatment Parameters When treatment... -
Page 39: Maintenance / Service
The word “service,” by contrast, refers to tasks that are intended to be performed only by a qualified service representative. Installation Policy For each new KXL System, a person trained by Avedro can • perform a full initial installation and start-up of the System. -
Page 40: Troubleshooting
KXL System Operator’s Manual | Page 34 4.5 Troubleshooting The KXL System checks its status at start-up automatically. If • the status is incorrect, the software prevents the operator from initiating treatments. 4.5.1 Wireless Remote The KXL System uses a remote control with replaceable •... -
Page 41: Internal Rechargeable Battery
Use a soft damp cloth to clean the system. • The exterior of the KXL System can be cleaned using a lint-free • cloth dampened with isopropyl alcohol. DO NOT submerge the system in liquid or pour liquid onto the •... -
Page 42: Cleaning The Aperture
KXL System Operator’s Manual | Page 36 4.8 Cleaning the Aperture CAUTION: The glass window of the beam aperture must not under any circumstances be in contact with any aggressive cleaning agents. Check the beam aperture routinely prior to treatment. -
Page 43: Figure 4-4. With Arm Raised, Tighten Set Screw (A)
AVEDRO | 37 of 49 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 44: Moving The System
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. Prior to moving the KXL System from one room to another, the • monitor should be moved sideways and the optics head should be positioned close to the cart handle with the elbow protruding at the back. -
Page 45: Storing The System
4.12 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. 4.13 Identifying Risks Associated with Disposing of Waste... -
Page 46: Performing A Visible Check
KXL System Operator’s Manual | Page 40 4.14 Performing a Visible Check Check all components of the device routinely for damage or • malfunction prior to each treatment. Do not use a damaged or malfunctioning device. Use of such •... -
Page 47: Equipment Classification
AVEDRO | 41 of 49 5 Equipment Classification Essential Performance The KXL system delivers to the cornea UV-A radiation of nominally 365 nm wavelength at an irradiance of 3 mW/cm over an exposure period of up to 30 minutes to deliver a total energy density of up to 5.4 J/cm... -
Page 48: Emc Guidance
KXL System Operator’s Manual | Page 42 EMC Guidance Guidance and manufacturer’s declaration - electromagnetic emissions 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 49: Table 5-2. Electromagnetic Immunity
AVEDRO | 43 of 49 — 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 50: Table 5-3. Electromagnetic Immunity (Continued)
KXL System Operator’s Manual | Page 44 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 51: Table 5-4. Recommended Separation Distances
AVEDRO | 45 of 49 Recommended separation distances between portable and mobile RF communications equipment and the KXL UV Illumination System The KXL UV Illumination System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the KXL UV Illumination System can help... -
Page 52: Rf Transmitters
KXL System Operator’s Manual | Page 46 5.4 RF Transmitters 5.4.1 RFID Reader 13.56MHz Reader/Writer • Integral Antenna: Maximum 4” Read Range • US/FCC number SX90RFID1 • Max output power is 200mW • Meets: ISO18000-3, ISO15693 • The highest emissions generated by the above equipment are listed below:... -
Page 53: Symbol Library
AVEDRO | 47 of 49 6 Symbol Library Text Symbol Symbol Illustration Definition 1. No AP symbol in Danger, Risk of Explosion. presence of flammable Not for use anesthetics 2. AC symbol Alternating current 3. “I” in a book Attention: Consult... - Page 54 KXL System Operator’s Manual | Page 48 Text Symbol Symbol Illustration Definition 13. Two up arrows Keep arrows on carton pointing up 14. Water drop in a box Humidity limits (percentages below symbol are the acceptable range for humidity) 15. Temperature limits...
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Page 55: Specifications
AVEDRO | 49 of 49 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 250 V~ T2AH...
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