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 ML-00002 Revision R Copyright 2018 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.
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Page 3: Table Of Contents
Initiating Treatment ..................3-17 3.12 Monitoring Treatment .................. 3-18 3.13 Stopping a Treatment ................... 3-18 3.14 Treatment Complete..................3-19 3.15 Pausing or Canceling a Treatment ............... 3-20 3.16 Powering Down the System ................. 3-22 KXL System Operator’s Manual, Rev R... - Page 4 Storing the System ..................4-4 4.13 Software ......................4-4 4.14 Identifying Risks Associated with Disposing of Waste Products ....4-4 4.15 Performing a Visible Check ................4-4 Equipment Classification ................. 5-1 Symbol Library ..................6-1 Specifications ..................... 7-1 KXL System Operator’s Manual, Rev R...
- Page 5 Figure 3-29. Cancel Treatment ........................ 3-21 Figure 3-30. Partial Treatment Information..................... 3-21 Figure 3-32. Power Off Position ......................3-22 Figure 3-33. KXL System Plug ........................3-23 Figure 3-34. Device Settings Menu ......................3-23 Figure 3-35. Edit System Language ......................3-24 Figure 3-36.
- Page 6 Chapter 1: Foreword Figure 4-2 Moving System Configuration ....................4-4 KXL System Operator’s Manual, Rev R...
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Page 7: Chapter: 1 Foreword
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 cross-linking procedures stabilizing cornea which have been weakened by disease or by refractive surgery. -
Page 8: Contraindications, Warnings And Cautions
Avedro service personnel. WARNING: Remove the wall plug and turn off the power switch before servicing or cleaning (disinfecting) the equipment. KXL System Operator’s Manual, Rev R... -
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
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 11: Introduction
(Riboflavin Induction Period, Total UV Energy, UV Power and UV Pulse Cycle Times) are selected through the user interface touch screen computer. The KXL System is used in conjunction with a Riboflavin solution and an RFID card. KXL System Operator’s Manual,... -
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 R... -
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 R... -
Page 15: System Operation
NOTE: the KXL battery should last for 16 hours during normal operation. The system software will notify the user when the battery needs to be charged. The KXL system prohibits a treatment if there is insufficient battery power to perform a treatment. (See chapter 4 Maintenance for more information on troubleshooting battery problems.) - Page 16 Session command and (Confirm Cancel returns to the Treatment Session screen) 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 R...
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Page 17: Uv Energy (Dose)
Check glass window of beam aperture for dust and dirt. See sections 4.8 and 4.9 for cleaning instructions. 3.5 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. KXL System Operator’s Manual, Rev R... -
Page 18: 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. Figure 3-1. Power Switch • The KXL System begins a power-up sequence, loading the operating system and all configuration and reference files. Figure 3-2. Startup Screen •... -
Page 19: Set Riboflavin Induction Period
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. 3.8.1 Continuous UV Treatment Mode • Select Continuous treatment mode. • When finished entering parameters, press the Checkmark button. KXL System Operator’s Manual, Rev R... -
Page 20: Figure 3-4. Select Continuous Treatment Mode Screen
When finished entering treatment parameters, press the Checkmark button. Figure 3-5. Continuous 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 R... -
Page 21: Pulsed Uv Exposure
NOTE: UV irradiation time is automatically calculated and displayed in the orange box. * The user may select UV Energy in 0.1 J/cm increments. The energy range is controlled by the RFID card. KXL System Operator’s Manual, Rev R... -
Page 22: Figure 3-8. Pulsed Treatment Parameters Screen
Figure 3-9. Set UV Pulse Cycle Times 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 R... -
Page 23: Starting Treatment
Chapter 3: System Operation Figure 3-10. Confirm Pulsed 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. KXL System Operator’s Manual, Rev R... -
Page 24: Single-Use Disposables
Chapter 3: System Operation Figure 3-11. Reading Disposables 3.9.1 Single-use disposables Figure 3-12. Reading Tag Screen • Hold until read is complete and discard tag or activation card. KXL System Operator’s Manual, Rev R 3-10... -
Page 25: Multi-Use Disposables
Chapter 3: System Operation 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. Figure 3-13. Treatments Remaining Figure 3-14. Final Treatment KXL System Operator’s Manual, Rev R 3-11... -
Page 26: 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 the following message will appear. Figure 3-16. Invalid Treatment Parameters • Press Back to Treatment Parameters to enter the appropriate parameter. KXL System Operator’s Manual, Rev R 3-12... -
Page 27: Sync Alignment Remote
Press the “S” button on the remote to synchronize the remote. This is required for every procedure. o Note: Pressing the Sync button is necessary even though the window prompting the Sync disappears. Indicator Light Status Meaning ON (Solid Blue) Synchronized with system Lost synchronization with system KXL System Operator’s Manual, Rev R 3-13... - Page 28 Chapter 3: System Operation 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. If the internal self-test fails, an error message will be generated and the treatment cannot proceed.
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Page 29: 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 30: Figure 3-20. Remote Functions
Red crosshair for X and Y axis positioning. o Green dot or a second Red crosshair for Z axis positioning. • Note: For correct alignment when using the Remote, the Avedro logo on optics head should face the user •... -
Page 31: Initiating Treatment
Figure 3-23. Induction Complete WARNING: Start treatments only after the photosensitizer is applied. CAUTION: UV light is emitted when the Avedro logo on the optical head changes color from blue to green. 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 32: Monitoring Treatment
OFF by pushing the Pause button. This can be done two times at most (see section 3.15). Figure 3-25. Treatment Paused Screen • To cancel or resume treatment press appropriately. See section 3.16 for powering down after cancellation. KXL System Operator’s Manual, Rev R 3-18... -
Page 33: 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 R 3-19... -
Page 34: Pausing Or Canceling A Treatment
Cancelled by selecting the Cancel Session button. • If the session is not Resumed within the two-minute Pause time, the treatment will automatically be Cancelled when the timer runs down. • If the session is resumed, treatment can continue. KXL System Operator’s Manual, Rev R 3-20... -
Page 35: Figure 3-29. Cancel Treatment
Pauses can only be used two times after which treatments can be Canceled by selecting the Cancel button. Figure 3-29. Cancel Treatment • The screen displays Partial Treatment Information Figure 3-30. Partial Treatment Information KXL System Operator’s Manual, Rev R 3-21... -
Page 36: Powering Down The System
Chapter 3: System Operation 3.16 Powering Down the System It is recommended that the KXL System be plugged into an electrical outlet when not in use or when stored. In order to maintain battery charge, it is recommended that the KXL be connected to a grounded supply mains at the end of each business day or when not in use. -
Page 37: Using The Device Settings Menu
Chapter 3: System Operation Figure 3-33. KXL System Plug • Plug the KXL System in to an electrical outlet until next use. 3.17 Using the Device Settings Menu • With the Initialization screen (New Patient Start) displayed, press and hold the KXL on the touch screen. -
Page 38: Editing System Language
Select the Edit Alignment Crosshairs Intensity button on the Device Settings menu. Figure 3-36. Edit Alignment Crosshairs Intensity 3.17.4 Editing System Volume • The Edit Volume option allows a user with the appropriate security level to edit the system volume level. KXL System Operator’s Manual, Rev R 3-24... -
Page 39: Copying Treatment Data To Usb
USB during treatment. • Select the Copy Treatment Data to USB button on the Device Settings menu. Figure 3-38. Device Settings Transfer to USB KXL System Operator’s Manual, Rev R 3-25... -
Page 40: 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 3-39. Select Default Treatment Mode • Press the Checkmark button to continue. KXL System Operator’s Manual, Rev R 3-26... -
Page 41: Figure 3-40. Edit Default Treatment Parameters (Continuous & Pulsed)
Chapter 3: System Operation Figure 3-40. Edit Default Treatment Parameters (Continuous & Pulsed) Figure 3-41. Edit Default UV Pulse Parameters (Pulsed Only) • When finished entering treatment parameters, press the Checkmark button. KXL System Operator’s Manual, Rev R 3-27... - Page 42 Chapter 3: System Operation This page is left blank intentionally. KXL System Operator’s Manual, Rev R 3-28...
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Page 43: 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 44: Trouble Shooting
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. If the light is orange or yellow the system is charging, if it is green it is fully charged. -
Page 45: Directions For Sterilization Or Disinfection
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. Use small amounts of liquid and soft fiber-free wipes. -
Page 46: Storing The System
4.13 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. 4.14 Identifying Risks Associated with Disposing of Waste Products •... - Page 47 Chapter 4: Maintenance/Service • Do not use a damaged or malfunctioning device. Use of such devices may harm the user and/or patient. KXL System Operator’s Manual, Rev R...
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Page 49: Equipment Classification
Alignment lasers are Class 1 Laser Product 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 o Class IIa KXL System Operator’s Manual, Rev R... -
Page 51: Symbol Library
Caution specific warning in 10. ! in a Triangle operators manual 11. Net Weight (kgs) Weight 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 R... - Page 52 16. Temperature limits Temperature storage/operating limits 17. Pressure limits Atmospheric pressure limits (storage / operating) 18. Signal emitted RF transmitted through device KXL System Operator’s Manual, Rev R...
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Page 53: 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% non-condensing Atmospheric pressure 500 to 1060 mbar KXL System Operator’s Manual, Rev R...
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