Avedro KXL System User manual

KXL System Operator’s Manual
ML-00006 Rev P
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
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. All rights reserved 2019.
Microsoft and Windows are registered trademarks and trademarks,
respectively, of Microsoft Corporation. Any other trademarks or service
marks contained within this manual are the property of their respective
owners.
CAUTION: Federal law restricts this device to sale by or on the order of a
physician.
For more information, contact: Avedro, Inc.
30 North Ave
Burlington, MA 01803
[phone]

KXL System Operator’s Manual
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Table of Contents
1Foreword .......................................................................................................................................... 1
1.1 Intended Use of Manual...............................................................................................................1
1.2 Intended Use / Indications for Use........................................................................................1
1.3 Confidentiality Disclaimer...........................................................................................................1
1.4 Reproduction Disclaimer ............................................................................................................1
1.5 User Operation Assistance Statement.................................................................................1
1.6 Contraindications, Warnings and Cautions.......................................................................1
1.6.1 Contraindications ...............................................................................................................1
1.6.2 Warnings ..............................................................................................................................2
1.6.3 Electrical Safety Warnings ..........................................................................................2
1.6.4 Radiation Safety Warnings .........................................................................................4
1.7 Patient Safety ..................................................................................................................................4
1.8 Additional Safety Considerations..........................................................................................4
1.9 Use in Specific Populations ......................................................................................................4
1.10 FCC Compliance Notice.............................................................................................................5
2Introduction.................................................................................................................................... 6
2.1 System Overview...........................................................................................................................6
2.1.1 Major Components ...........................................................................................................7
3System Operation .......................................................................................................................10
3.1 Charging the KXL System Battery......................................................................................10
3.2 Touchpad/Keyboard Use ..........................................................................................................11
3.3 UV Dose............................................................................................................................................ 12
3.4 Preparing the System................................................................................................................ 12
3.5 Important Steps Before Turning on the System.......................................................... 12
3.6 Powering Up the System......................................................................................................... 12
3.7 Confirm Riboflavin Induction Period.................................................................................. 13
3.8 Confirm UV Treatment.............................................................................................................. 14
3.8.1 Confirm UV Dose ........................................................................................................... 14
3.9 Starting Treatment...................................................................................................................... 15
3.9.1 Single-use Disposables................................................................................................ 16
3.9.2 Multi-use Disposables................................................................................................. 16
3.9.3 Sync Alignment Remote ........................................................................................... 17
3.10 Preparing the Patient................................................................................................................. 18
3.11 Administration of Photrexa Viscous .................................................................................. 18
3.12 Confirm Riboflavin Absorption............................................................................................20
3.13 Confirm Corneal Thickness....................................................................................................20
3.14 Alignment of the Device .........................................................................................................20
3.15 Initiating Treatment ................................................................................................................... 22
3.16 Monitoring Treatment .............................................................................................................. 23
3.17 Stopping a Treatment ..............................................................................................................24

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3.18 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..........................................................30
3.22.3 Editing System Volume..........................................................................................30
3.22.4 Copying Treatment Data to USB....................................................................... 31
3.22.5 Confirming Treatment Settings ......................................................................... 32
4Maintenance / Service..............................................................................................................33
4.1 Installation Policy........................................................................................................................ 33
4.2 Customer Maintenance............................................................................................................ 33
4.3 Warranty Information............................................................................................................... 33
4.4 Service Contract Information ............................................................................................... 33
4.5 Troubleshooting ..........................................................................................................................34
4.5.1 Wireless Remote ...........................................................................................................34
4.5.2 Internal Rechargeable Battery.............................................................................. 35
4.6 Directions for Sterilization or Disinfection..................................................................... 35
4.7 Cleaning the System ................................................................................................................. 35
4.8 Cleaning the Aperture..............................................................................................................36
4.9 Articulating Arm Adjustment ...............................................................................................36
4.10 Moving the System ....................................................................................................................38
4.11 Storing the System ....................................................................................................................39
4.12 Software ..........................................................................................................................................39
4.13 Identifying Risks Associated with Disposing of Waste Products ......................39
4.14 Performing a Visible Check .................................................................................................. 40
5Equipment Classification ..........................................................................................................41
5.1 Essential Performance............................................................................................................... 41
5.2 Equipment Classification ......................................................................................................... 41
5.3 EMC Guidance ..............................................................................................................................42
5.4 RF Transmitters ...........................................................................................................................46
5.4.1 RFID Reader ....................................................................................................................46
5.4.2 Wireless Remote Control.........................................................................................46
6Symbol Library ............................................................................................................................47
7Specifications...............................................................................................................................49

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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. Power Switch................................................................................................................................... 13
Figure 3-2. Startup Screen ............................................................................................................................... 13
Figure 3-3. Induction Period Screen............................................................................................................ 14
Figure 3-4. UV Energy Dose............................................................................................................................ 14
Figure 3-5. Confirm Treatment Parameters Screen............................................................................ 15
Figure 3-6. Reading Activation Card .......................................................................................................... 15
Figure 3-7. Treatments Remaining............................................................................................................... 16
Figure 3-8. Final Treatment ............................................................................................................................. 16
Figure 3-9. No Treatments Remaining....................................................................................................... 17
Figure 3-10. Remote Sync Status.................................................................................................................. 17
Figure 3-11. Prepare Patient Screen ............................................................................................................. 19
Figure 3-12. Prepare Patient Screen: KXL Timer Disabled ............................................................... 19
Figure 3-13. Align Crosshairs During Induction ..................................................................................... 21
Figure 3-14. Remote Functions ...................................................................................................................... 21
Figure 3-15. Red Crosshairs X & Y Axes, Red Crosshairs Z Axis Alignment........................... 21
Figure 3-16. Induction Complete .................................................................................................................. 22
Figure 3-17. Treatment Screen ...................................................................................................................... 23
Figure 3-18. Apply Riboflavin Reminder Screen................................................................................... 23
Figure 3-19. Treatment Paused Screen.....................................................................................................24
Figure 3-20. Treatment Complete Screen .............................................................................................. 25
Figure 3-21. Confirm Cancel Session Screen..........................................................................................26
Figure 3-22. Confirm Cancel Partial Treatment....................................................................................26
Figure 3-23. Partial Treatment Information............................................................................................ 27
Figure 3-24. Partial Treatment Information............................................................................................ 27
Figure 3-25. Power Off...................................................................................................................................... 28
Figure 3-26. Power Off Position................................................................................................................... 28
Figure 3-27. KXL System Plug....................................................................................................................... 28
Figure 3-28. KXL System Battery Status Indicator ............................................................................29

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Figure 3-29. Device Settings Menu.............................................................................................................29
Figure 3-30. Edit Alignment Crosshairs Intensity ...............................................................................30
Figure 3-31. Edit Volume ..................................................................................................................................30
Figure 3-32. Data Transfer to USB............................................................................................................... 31
Figure 3-33. Edit Default Treatment Parameters ................................................................................ 32
Figure 4-1. Alignment Remote Lost Sync................................................................................................34
Figure 4-2. Position the Arm Parallel to the Floor ..............................................................................36
Figure 4-3. Turn the Adjustment Screw...................................................................................................36
Figure 4-4. With Arm Raised, Tighten Set Screw (A)....................................................................... 37
Figure 4-5. With Arm Horizontal, Tighten Set Screw (B) ............................................................... 37
Figure 4-6. Summary of Further Counterbalance Adjustments..................................................38
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

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1Foreword
1.1 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.
1.2 Intended Use / Indications for Use
The KXL® System is indicated for use with PHOTREXA (riboflavin 5’-
phosphate ophthalmic solution) and PHOTREXA VISCOUS (riboflavin 5’-
phosphate in 20% dextran ophthalmic solution) in corneal collagen cross-
linking for the treatment of progressive keratoconus and corneal ectasia
after refractive surgery.
1.3 Confidentiality Disclaimer
All patient data appearing in this document, including the sample screen
graphics, are fictitious and representative only. No patient’s confidentiality
has been violated, with or without permission.
1.4 Reproduction Disclaimer
Neither this manual nor any part of it may be reproduced, photocopied,
or electronically transmitted in any way without the advanced written
permission of Avedro, Inc.
1.5 User Operation Assistance Statement
Should you experience any difficulty in running your KXL System, please
contact your local Avedro authorized representative.
1.6 Contraindications, Warnings and Cautions
1.6.1 Contraindications
None.

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1.6.2 Warnings
Ulcerative keratitis can occur. Epithelial defects should be
monitored until resolution.
1.6.3 Electrical Safety Warnings
This equipment 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 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.
Even with the power cord removed, there is the potential
for an electrical shock from the 12VDC internal power
source.
The system is designed for continuous operation using the
external connector or its internal rechargeable battery.
WARNING: This equipment is operated with hazardous
voltages that can shock, burn, or cause death. To reduce
the possibility of electrical shock, and inadvertent 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.
WARNING: Remove the wall plug and turn off the power
switch before servicing or cleaning (disinfecting) the
equipment.
Never pull cords to remove the power cord from the outlet.
Grasp the power cord plug and pull it from the outlet to
disconnect.
WARNING: Do not operate the equipment with a damaged
power cord.

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WARNING: Position the power cord so that it cannot be
tripped over, walked on, rolled over, crimped, bent,
pinched, or accidentally pulled from the wall outlet.
WARNING: Do not use the instrument near water and be
careful not to spill liquids on any part of it.
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.
WARNING: Do not use adjacent to or stack with other
equipment; if it is used adjacent to or stacked with other
equipment, verify that the equipment behaves normally as
intended.
WARNING: No modification of this equipment is allowed.
WARNING: MR Unsafe – Keep away from magnetic
resonance imaging equipment.

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1.6.4 Radiation Safety Warnings
WARNING: Never look directly into the UV light beam nor
direct the beam towards a person except for therapeutic
purposes.
WARNING: Always wear UVA protective goggles when the
KXL system is turned on.
WARNING: Use only laser grade instruments in order to
prevent reflected UV radiation from smooth metallic
surfaces.
1.7 Patient Safety
The treatment should take place in a quiet atmosphere in order not to
distract the attention of the patient.
•The patient should lie on a table or patient's chair.
•The patient’s head should rest comfortably in a headrest. It is
imperative that the table or patient’s chair and 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.
1.8 Additional Safety Considerations
•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.
1.9 Use in Specific Populations
•The safety and effectiveness of corneal collagen cross-linking
has not been established in pediatric patients below the age of
14 years.

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1.10 FCC Compliance Notice
This equipment has been tested and found to comply with the limits for a
Class B digital device, pursuant to Part 15 of the FCC Rules. These limits
are designed to provide reasonable protection against harmful
interference in a residential environment.
This equipment generates, uses, and can radiate radio frequency energy
and, if not installed and used in accordance with the instruction manual,
may cause harmful interference to radio communications. However, there
is no guarantee that interference will not occur in a particular installation.
If this equipment does cause harmful interference to radio or television
reception, which can be determined by turning the equipment off and on,
the user is encouraged to try to correct the interference by one or more
of the following measures:
•Reorient or relocate the receiving antenna.
•Increase the separation between the equipment and receiver.
•Connect the equipment into an electrical outlet on a circuit
different from that to which the receiver is connected.
•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. Unauthorized changes or modifications could void the
user's authority to operate the equipment.

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2Introduction
2.1 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. Irradiating the riboflavin phosphates
ophthalmic solution creates singlet oxygen, which forms intermolecular
bonds in corneal collagen. UV flux and irradiation time (that is, fluence) at
the cornea are controlled by an onboard computer system.
The Optics Head houses the UVA irradiation mechanism. The LED emits
continuous UVA radiation at a wavelength of 365 nm at an intensity of 3
mW/cm2.
A fixed aperture mounted in the UVA irradiation beam path is used to
produce a circular area of irradiation at the treatment plane with a
diameter of 9.5 mm. Alignment lasers are used to aid the user in focusing
the beam on the patient’s cornea. Fine alignment of the UV beam through
observation of the alignment lasers is controlled by the user through a
wireless remote.
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. The treatment parameters
(Riboflavin Induction Period, Total UV Energy and UV Power) are
confirmed through the user interface touch screen computer.
The KXL System is used in conjunction with Photrexa Viscous and
Photrexa 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. Actual product may vary.

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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

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Figure 2-2. System Illustrations with Callouts
Figure 2-3. Wireless Remote

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Figure 2-4. KXL Label
Figure 2-5. UV emitting Label
Figure 2-6. Alignment Laser Classification Label

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3System Operation
3.1 Charging the KXL System Battery
NOTE: Prior to initial use, the internal battery pack of the KXL must be
charged overnight.
•In order to maintain battery charge, it is recommended that the
KXL be connected to a grounded mains supply at all times or at
the end of each business day, including when not in use.
•The charging status of the battery is identified by the color of
the light located on the column of the KXL.
-Red/Orange: Low, charging
-Yellow: Charging
-Green: Fully charged
•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.
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.)

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3.2 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
(Initial screen)
Turns OFF electric power to
the internal computer.
Start New Treatment
button (Initial screen)
Starts a new clinical
treatment protocol.
UP arrow
(various Clinical Protocol
screens)
Increases the value of the
current field.
DOWN arrow
(various Clinical Protocol
screens)
Decreases the value of the
current field.
X button
(various Device Settings
screens)
Cancels all the entries on a
particular screen and returns
to the previous screen.
Checkmark button
(various Clinical Protocol
screens and Device
Settings screen)
Directs the system to accept
the current screen entries
and to proceed to the next
step.
Cancel Session button
(various Clinical Protocol
screens)
Cancels a treatment session
for a particular patient. A
prompt is then displayed to
confirm your decision.
Return button
(various Device Settings
screen)
Returns to the Device
Settings menu.
CAUTION: Only qualified and experienced personnel shall
operate the KXL System.

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3.3 UV Dose
•The UV Energy (Dose) is the product of the UV Power
(Irradiance) and the UV Irradiation Time. The UV Energy, the UV
Power and the UV Irradiation Time are displayed on the user
interface.
•The System tracks UV Energy, UV Power, UV Irradiation Time
and Total Treatment Time during the treatment.
•NOTE: The System's parameters are:
-Induction Period: 30 minutes
-Wavelength: 365 nm
-UV Energy: 5.4 J/cm2
-UV Power: 3 ± 10% mW/cm2
-UV Irradiation Time: 30 minutes
3.4 Preparing the System
•Position the KXL System adjacent to the treatment table or
chair. Lock the casters to secure the device’s position.
•Check glass window of beam aperture for dust and dirt. See
Sections 4.7 and 4.8 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.
•To ensure the System is functioning properly, consider the
following mandatory points:
-Inspect the device, accessories, and connecting cables
for visible damage.
-Take into consideration your local regulations for use
of portable electro-optical medical devices.
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.

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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.
NOTE: If there is a start-up error, please note any error messages
and contact your distributor or Customer Service immediately.
3.7 Confirm Riboflavin Induction Period
•To begin patient treatment, press the Start New Treatment
button.
•Confirm the length of the induction period (30 min) for the
patient.
•To proceed, press the Checkmark button.

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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/cm2)
-UV Power (3 mW/cm2)
NOTE: UV irradiation time is displayed in the orange box.
Figure 3-4. UV Energy Dose
WARNING: The Treatment Activation Card is pre-
programmed with above parameters and will only confirm
the above energy and power dose.