Avedro, Inc.
KXL System
Operator’s Manual

ML-00002

Revision J
Effective Date 05 Mar 2013

Copyright 2013
Printed in U.S.A.

All Rights Reserved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 2013.
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.

For more information, contact:Your Local Avedro-authorized distributor
Avedro, Inc.
230 Third Avenue
Waltham, MA 02451
Authorized Representative
EMERGO EUROPE
Molenstraat 152513 BH, The Hague
The Netherlands
Phone: +31.70.345.8570
Fax: +31.70.346.7299

0470

Table of Contents
Chapter:1
Forward ..................................................................................................... 1-1
1.1
Intended Use of Manual ................................................................................. 1-1
1.2
Intended Use / Indications for Use................................................................. 1-1
1.3
Design Change Disclaimer ............................................................................ 1-1
1.4
Reproduction Disclaimer ............................................................................... 1-1
1.5
User Operation Assistance Statement ............................................................ 1-1
1.6
Contraindications, Warnings and Cautions.................................................... 1-2
1.6.1 Contraindications ............................................................................... 1-2
1.6.2 Warnings ............................................................................................ 1-2
1.6.3 Electrical Safety Warnings ................................................................. 1-2
1.7
Patient Safety ................................................................................................. 1-3
1.8
Additional Safety Considerations .................................................................. 1-4
1.9
FCC Compliance Notice ................................................................................ 1-4
2
Introduction ............................................................................................... 2-1
2.1
System Overview ........................................................................................... 2-1
2.1.1 Major Components ............................................................................. 2-2
3
System Operation ...................................................................................... 3-1
3.1
Charging the KXL Battery ............................................................................. 3-1
3.2
Touchpad/Keyboard Use ............................................................................... 3-1
3.3
UV Energy (Dose) ......................................................................................... 3-3
3.4
Preparing the System ..................................................................................... 3-3
3.5
Important Steps before Turning on the System ............................................. 3-4
3.6
Powering Up the System ................................................................................ 3-4
3.7
Set Riboflavin Induction Period..................................................................... 3-5
3.8
Select Treatment Mode .................................................................................. 3-6
3.8.1 Continuous UV Treatment Mode ....................................................... 3-6
3.8.2 Pulsed UV Exposure .......................................................................... 3-8
3.9
Starting Treatment ....................................................................................... 3-11
3.9.1 Single-use disposables...................................................................... 3-12
3.9.2 Multi-use disposables ....................................................................... 3-12
3.9.3 RFID card controlled limits.............................................................. 3-13
3.9.4 Sync Alignment Remote .................................................................. 3-14
3.10 Preparing the Patient .................................................................................... 3-16
3.11 Initiating Treatment ..................................................................................... 3-19
3.12 Monitoring Treatment .................................................................................. 3-19
3.13 Stopping a Treatment ................................................................................... 3-20
3.14 Treatment Complete..................................................................................... 3-20
3.15 Pausing or Canceling a Treatment ............................................................... 3-22
3.16 Powering Down the System ......................................................................... 3-24
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3.17

4
4.1
4.2
4.3
4.4
4.5
4.6
4.7
4.8
4.9
4.10
4.11
4.12
4.13
4.14
4.15
4.16
5
6
7

Using the Device Settings Menu.................................................................. 3-25
3.17.1 Advanced Settings .......................................................................... 3-26
3.17.2 Editing System Language............................................................... 3-27
3.17.3 Editing Alignment Crosshairs Intensity ......................................... 3-27
3.17.4 Editing System Volume ................................................................. 3-28
3.17.5 Copying Treatment Data to USB ................................................... 3-28
3.17.6 Editing Default Treatment Parameters Screen ............................... 3-30
Maintenance / Service ............................................................................... 4-1
Installation Policy .......................................................................................... 4-1
Customer Maintenance .................................................................................. 4-1
Warranty Information .................................................................................... 4-1
Service Contract Information ......................................................................... 4-1
Per Patient Disposables .................................................................................. 4-1
Trouble Shooting ........................................................................................... 4-2
Directions for Sterilization or Disinfection.................................................... 4-3
Cleaning the System ...................................................................................... 4-3
Cleaning the Aperture .................................................................................... 4-3
Articulating Arm Adjustment ........................................................................ 4-3
Performing Periodic Maintenance ................................................................. 4-4
Moving the System ........................................................................................ 4-4
Storing the System ......................................................................................... 4-4
Software ......................................................................................................... 4-4
Identifying Risks Associated with Disposing of Waste Products .................. 4-4
Performing a Visible Check ........................................................................... 4-4
Equipment Classification ......................................................................... 5-1
Symbol Library ......................................................................................... 6-1
Specifications .................................................................................................1

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Table of Figures
Figure 2-1. Overview Illustration of System ................................................................... 2-2
Figure 2-2. System Illustrations with Callouts ................................................................ 2-3
Figure 2-3. Wireless Remote ........................................................................................... 2-3
Figure 2-4. KXL Label .................................................................................................... 2-4
Figure 2-5. UV emitting Label......................................................................................... 2-4
Figure 2-6. Laser Classification Label ............................................................................. 2-4
Figure 3-1. Power Switch ................................................................................................ 3-4
Figure 3-2. Startup Screen ............................................................................................... 3-5
Figure 3-3. Induction Period Screen ................................................................................ 3-5
Figure 3-4. Select Continuous Treatment Mode Screen .................................................. 3-6
Figure 3-5. Continuous Treatment Parameters Screen .................................................... 3-7
Figure 3-6. Confirm Continuous Treatment Parameters Screen ...................................... 3-7
Figure 3-7. Select Pulsed Treatment Mode Screen .......................................................... 3-8
Figure 3-8. Pulsed Treatment Parameters Screen ............................................................ 3-9
Figure 3-9. Set UV Pulse Cycle Times Screen ................................................................ 3-9
Figure 3-10. Confirm Pulsed Treatment Parameters Screen ......................................... 3-10
Figure 3-11. Reading Disposables ................................................................................. 3-11
Figure 3-12. Reading Tag Screen .................................................................................. 3-12
Figure 3-13. Treatments Remaining .............................................................................. 3-12
Figure 3-14. Final Treatment ......................................................................................... 3-13
Figure 3-15. No Treatments Remaining ........................................................................ 3-13
Figure 3-16. Invalid Treatment Parameters ................................................................... 3-14
Figure 3-17. System Setup Status .................................................................................. 3-14
Figure 3-18. Prepare Patient Screen............................................................................... 3-16
Figure 3-19. Align Crosshairs during induction ............................................................ 3-17
Figure 3-20. Remote Functions...................................................................................... 3-17
Figure 3-21. Red Crosshairs X & Y Axes, Green Dot Z Axis Alignment .................... 3-18
Figure 3-22. Red Crosshairs X & Y Axes, Red Crosshairs Z Axis Alignment ............. 3-18
Figure 3-23. Induction Complete ................................................................................... 3-19
Figure 3-24. Treatment Screen ...................................................................................... 3-19
Figure 3-25. Treatment Paused Screen .......................................................................... 3-20
Figure 3-26. Treatment Complete Screen ...................................................................... 3-21
Figure 3-27. Initial Confirm Cancel Session Screen ..................................................... 3-22
Figure 3-28. Confirm Cancel Partial Treatment ............................................................ 3-22
Figure 3-29. Partial Treatment Information ................................................................... 3-23
Figure 3-30. Power Off .................................................................................................. 3-24
Figure 3-31. Power Off Position .................................................................................... 3-25
Figure 3-32. KXL System Plug ..................................................................................... 3-25
Figure 3-33. Device Settings Menu ............................................................................... 3-26
Figure 3-34. Edit System Language............................................................................... 3-27
Figure 3-35. Edit Alignment Crosshairs Intensity ......................................................... 3-27
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Figure 3-36. Edit Volume .............................................................................................. 3-28
Figure 3-37. Device Settings Transfer to USB .............................................................. 3-29
Figure 3-38. Select Default Treatment Mode ................................................................ 3-30
Figure 3-39. Edit Default Treatment Parameters (Continuous & Pulsed) ..................... 3-30
Figure 3-40. Edit Default UV Pulse Parameters (Pulsed Only)..................................... 3-31
Figure 4-1. Remote Lost Sync ......................................................................................... 4-2

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1

Forward

1.1 Intended Use of ManualThis manual is designed to serve the operators of the Avedro, Inc. KXL System. All operating
instructions, product illustrations, screen graphics, troubleshooting/error messages, and otherrelevant information are contained in this manual. It is the operator’s responsibility to ensure thatall safety instructions in this manual are applied strictly.

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

1.3 Design Change Disclaimer

Due to design changes and product improvements, information in this manual is subject tochange without notice. Avedro, Inc. (hereafter called “Avedro”) reserves the right tochange product design at any time without notice, which may subsequently affect thecontents of this manual.



Avedro assumes no responsibility for any errors that may appear in this manual. Avedro
will make every reasonable effort to ensure that this manual is up to date and correspondswith the shipped KXL System.



The computer display screens depicted in this manual are representative only. Dependingon the software version of the system, minor differences may appear between the actual
computer displays and those shown in this manual.

All patient data appearing in this document, including the sample screen graphics, arefictitious and representative only. No patient’s confidentiality has been violated, with orwithout 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.

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Chapter 1: Forward

1.6 Contraindications, Warnings and Cautions
1.6.1

Contraindications

This section describes situations in which the device should not be used because the risk of use
clearly outweighs any possible benefit. Conditions that may contraindicate the use of the device
include:








1.6.2

Corneal thickness, with epithelium, of less than < 375 microns.
Prior corneal surgery
Corneal melting disorders
Aphakic patients
Pseudophakic patients without UV blocking lens implanted
Pregnant and nursing womenChildren

Warnings

Physicians should evaluate the potential benefits in patients with the following conditions:



1.6.3

Herpes simplex, herpes zoster keratitis, recurrent corneal erosion, corneal dystrophy
Epithelial healing disorders

Electrical Safety Warnings
For Equipment Classifications please refer to chapter 5.0 Equipment Classifications

WARNING: To avoid the risk of shock this equipment must only beconnected to a supply mains with protective earth.
Even with the power cord removed, there is the potential for an electricalshock 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. Ensurethat 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.

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Chapter 1: Forward



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 thepower cord plug and pull it from the outlet to disconnect.



WARNING: Do not operate the equipment with a damaged power cord.



WARNING: Position the power cord so that it cannot be tripped over,walked on, rolled over, crimped, bent, pinched, or accidentally pulled fromthe wall outlet.



WARNING: Do not use the instrument near water and be careful not tospill liquids on any part of it.



WARNING: The USB port can only be used when the system is not intreatment mode, do not connect to the USB during treatment.



WARNING: Do not operate the KXL System in the presence of flammablemixtures or anesthetics.



WARNING: Never look directly into the UV light beam. Never direct thebeam towards a person except for therapeutic purposes.



WARNING: The remote contains replaceable batteries; if system is notgoing to be used for an extended period of time remove the batteries.

1.7 Patient Safety

The treatment should take place in a quiet and relaxed 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 chairor the system not be moved during the treatment procedure.
CAUTION: The KXL System is a medical device. It may be operated, therefore, only inhealth care facilities or medical areas under the supervision of medically trained personnel.

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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 opticalelements 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. Therefore, only Avedro
recommended accessories or stainless steel surgical instruments should be used.



Smooth metallic surfaces can reflect despite the effort to blank them. Therefore, only laser
grade instruments should be used.

1.9 FCC Compliance NoticeThis 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 canradiate 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 guaranteethat interference will not occur in a particular installation. If this equipment does cause harmfulinterference 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 thereceiver 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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2

Introduction

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 a solution of Riboflavin has been applied.
Irradiating the Riboflavin creates singlet oxygen, which forms intermolecular bonds in corneal
collagen, stiffening the cornea through cross-linking. 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 is preset by the manufacturer
to emit UVA radiation at a wavelength of 365 nm at an intensity of 3 mW/cm2 to 45 mW/cm2.
A fixed aperture mounted in the UVA irradiation beam path is used to produce a uniform circulararea of irradiation at the treatment plane with an approximate diameter of 9 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 through a wireless remote and aninternal drive system. Treatment power is selectable by the user from 3 mW/cm2 to 45 mW/cm2
in 1 mW/cm2 increments. Total Energy is selectable in 0.1J increments on the user interface, but
the actual limits are controlled by the RFID treatment card.
The KXL is a portable system with an articulating arm to allow movement of the system foralignment of the UV Beam to the patient’s cornea. An internal battery powers the system; thebattery is recharged by a system internal charger from any standard AC outlet. The treatment
parameters (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.

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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)

KXL Accelerated Crosslinking Treatment Kit (disposable supplied separately)

Figure 2-1. Overview Illustration of 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. Laser Classification LabelKXL System Operator’s Manual,
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3

System Operation

3.1 Charging the KXL 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 agrounded supply mains at the end of each business day or when not in use.



The charging status of the battery is identified by the color of the light located on thecolumn of the KXL.
oooOrange – low, charging
Yellow – charging
Green – fully 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 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 systemprohibits a treatment if there is insufficient battery power to perform a treatment. (Seechapter 4 Maintenance for more information on troubleshooting battery problems.)

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 tothe personal computer.

Start New Treatment
button (Initial screen)

Directs the system to repeat
the entire clinical treatment
protocol so the physician
can treat another patient.

Touchpad Key

Icon

Description/Function
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Chapter 3: System Operation

UP arrow(various ClinicalProtocol screens)

Increases the value of thecurrent field.

DOWN arrow(various ClinicalProtocol screens)

Decreases the value of thecurrent field.

X button(various Device
Settings screens)

Cancels all the entries on aparticular screen andreturns to the previous
screen.

Checkmark button(various ClinicalProtocol screens andDevice Settings
screen)Directs the system to accept
the current screen entries
and to proceed to the next
step.

Cancel Session
button(various ClinicalProtocol screens)

Cancels a treatment session
for a particular patient. A
prompt is then displayed toconfirm your decision.

Return to Treatment
button(Confirm Cancel
Session screen)

Cancels the Cancel Sessioncommand and returns to theTreatment screen.

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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Chapter 3: System Operation

3.3 UV Energy (Dose)The UV Energy (Dose) is the product of the UV Power (Intensity) and the UV Irradiation
Time. The UV Energy and UV Power are adjustable and the calculated UV Irradiation
Time is displayed.

The system tracks UV Energy, UV Power, UV Irradiation Time and Total Treatment
Time during the treatment.



There are two UV treatment modes available, Continuous and Pulsed.
Continuous Mode: UV output is constant for the duration of the UV treatment.
Continuous Mode Parameters:
Induction Period:

1 second – 30 minutes*UV Energy:
UV Power:3 – 45 mW/cm2* The user may select UV Energy in 0.1 Joule increments. The Energy range iscontrolled by the RFID card.


Pulsed Mode: UV output turns ON and OFF at user selected intervals.
Pulsed Mode Parameters:
Induction Period:

1 second – 30 minutes*UV Energy:
UV Power:

15 – 45 mW/cm2

UV ON Time:

1.0 – 4.0 Seconds

UV OFF Time:

1.0 – 4.0 Seconds* The user may select UV Energy in 0.1 Joule increments. The Energy range iscontrolled by the RFID card.

Please reference Riboflavin Instructions for Use (IFU) for formulation information.

3.4 Preparing the SystemPosition the KXL System adjacent to the treatment table or chair. Lock the casters tosecure the device’s position.

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Chapter 3: System Operation

Make sure the system is turned ON.

Check glass window of beam aperture for dust and dirt. See sections 4.8 and 4.9 forcleaning 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 ingood-working condition before starting a treatment.

To ensure the system is functioning properly, consider the following mandatory points:oInspect the device, accessories, and connecting cables for visible damage.

oTake local regulations for use of portable electro-optical medical devices into
consideration.

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.

Figure 3-1. Power Switch



The KXL System begins a power-up sequence, loading the operating system and all
configuration and reference files.

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Chapter 3: System Operation

Figure 3-2. Startup Screen

To begin patient treatment, press the Start New Treatment button.

Please see section 3.15 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 Set Riboflavin Induction PeriodSpecify the desired Riboflavin Induction Period (1 sec – 30 min).

When finished entering parameters, press the Checkmark button.

Figure 3-3. Induction Period Screen
NOTE: Default treatment parameters will auto-populate user selectable fields but
are adjustable. Defaults settings can be changed (see section 3.16.5, Editing Default
Treatment Parameters Screen).
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Chapter 3: System Operation

3.8 Select 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.

3.8.1

Continuous UV Treatment Mode

Select Continuous treatment mode.

When finished entering parameters, press the Checkmark button.

Figure 3-4. Select Continuous Treatment Mode ScreenEnter the desired UV treatment parameters:o*Total Energyo

UV Power (3 – 45 mW/cm2)

NOTE: UV irradiation time is displayed in the orange box.
* The user may select UV Energy in 0.1 Joule increments. The Energy range iscontrolled by the RFID card.
When finished entering treatment parameters, press the Checkmark button.

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Chapter 3: System Operation

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.

Figure 3-6. Confirm Continuous Treatment Parameters Screen

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Chapter 3: System Operation

3.8.2

Pulsed UV ExposureSelect Pulsed treatment modeWhen finished entering parameters, press the Checkmark button.

Figure 3-7. Select Pulsed Treatment Mode ScreenEnter the desired UV treatment parameters:o*Total Energyo

UV Power (15 – 45 mW/cm2)o

NOTE: UV irradiation time is displayed in the orange box.
* The user may select UV Energy in 0.1 Joule increments. The Energy range iscontrolled by the RFID card.

When finished entering treatment parameters, press the Checkmark button.

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Chapter 3: System Operation

Figure 3-8. Pulsed Treatment Parameters ScreenSelect the desired times in which the UV is cycled ON and OFFWhen finished entering treatment parameters, press the Checkmark button.

Figure 3-9. Set UV Pulse Cycle Times Screen

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Chapter 3: System Operation

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 Treatment Parameters Screen

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Chapter 3: System Operation

3.9 Starting Treatment
Place the activation card on the RFID reader and hold in place until the system emitsa beep.

Figure 3-11. Reading Disposables

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3.9.1

Single-use disposables

Figure 3-12. Reading Tag Screen


3.9.2

Hold until read is complete and discard tag or activation card.

Multi-use disposables
Once a multi-use activation card has been scanned, the display will show the numberof treatments remaining on the card.

Figure 3-13. Treatments Remaining

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Figure 3-14. Final Treatment

Figure 3-15. No Treatments Remaining

3.9.3

RFID card controlled limits


If the user has previously programmed an UV Energy range that is outside theallowable value(s) controlled by the RFID card the following message will appear.

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Chapter 3: System Operation

Figure 3-16. Invalid Treatment Parameters


3.9.4

Press Back to Treatment Parameters to enter the appropriate parameter.

Sync Alignment Remote

Figure 3-17. System Setup Status

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Chapter 3: System Operation



Press the “S” button on the remote to synchronize the remote within the 15 second window
displayed on the screen. This is required for every procedure.

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3.10 Preparing the PatientEnsure that the patient is lying flat or reclined on a patient table or chair. His or herhead should rest in a head rest.



Adjust the table or chair and head rest so that the patient can rest comfortably for theduration of the treatment without head movement.



Apply a lid speculum and optional drapes using standard clinical technique.



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 thismanual. For details of component use, please refer to the component’s Directions for Use.

Figure 3-18. Prepare Patient Screen
NOTE: Once the Riboflavin is applied to the eye, Start the induction by pressing the“Riboflavin Applied: Start Timer” button.

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Figure 3-19. Align Crosshairs during induction

KXL has two alignment lasers.
o

Red crosshair for X and Y axis positioning.

oGreen dot or a second Red crosshair for Z axis positioning.

Note: For correct alignment when using the Remote, the Avedro logo on optics headshould face the user

Manually move the Optics head back and forth and left and right until the X/Y axes’ Red
crosshairs are aligned to the center of the pupil.



Manually move the Optics head up and down to align the Z axis green dot or second red
crosshair to the center of the first red crosshair.



Fine tune the alignment as needed using the wireless remote.

Figure 3-20. Remote Functions

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Chapter 3: System Operation

Figure 3-21. Red Crosshairs X & Y Axes, Green Dot Z Axis Alignment

Figure 3-22. Red Crosshairs X & Y Axes, Red Crosshairs Z Axis Alignment

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3.11 Initiating Treatment


When the Induction Time is complete the “Begin UV Treatment” button will appear.
Press the “Begin UV Treatment” button to initiate 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 state.

WARNING: Make sure that the KXL System and the patient’s table orchair are secured and not moved after alignment and during treatment.

3.12 Monitoring Treatment
Check continuously that the area of interest on the cornea is illuminated with the UVA
light and adjust as necessary using the wireless remote.

Figure 3-24. Treatment Screen
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Chapter 3: System Operation

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 fixate on the red X & Y alignment crosshair throughout the treatment.



Patients should remain still during the treatment.

3.13 Stopping a Treatment


The treatment stops automatically after the user-programmed timer expires.



The user may decide to stop or interrupt the treatment. In such case, the UV light can beswitched OFF by pushing the Pause button.

Figure 3-25. Treatment Paused ScreenTo cancel or resume treatment press appropriately. See section 3.15 if canceling asession.

3.14 Treatment Complete

At the completion of a treatment the Total Treatment Parameters will be displayed andthe screen will show Treatment complete. Press Start New Treatment to initiate next
treatment.

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Figure 3-26. Treatment Complete Screen

To exit treatment and / or start a new treatment press Start New Treatment.



If treatments are complete Power OFF the system using the “Power Off” button on theMain Screen.



Carefully remove the device from the patient area.



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.

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3.15 Pausing or Canceling a Treatment
If session is canceled screen displays with Confirm Cancel Session.

Figure 3-27. Initial Confirm Cancel Session ScreenTo cancel session press Cancel Session.



If the session is Paused the screen displays Confirm Cancel Partial Treatment.

Figure 3-28. Confirm Cancel Partial Treatment
To cancel session press Cancel Session.

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The screen displays Partial Treatment Information

Figure 3-29. Partial Treatment Information

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3.16 Powering Down the System
It is recommended that the KXL System be plugged into an electrical outlet when not in use orwhen stored.

Figure 3-30. Power OffPress the “Power Off” on the touch screen monitor.

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Chapter 3: System Operation

Figure 3-31. Power Off Position
Turn the system power switch to the “Off” position.

Figure 3-32. 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.

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Figure 3-33. Device Settings Menu

3.17.1 Advanced Settings

Advanced Settings are only available to Avedro and Service personnel with a KXLAdvanced Settings access card. If selected the user will be prompted to scan an accesscard.

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3.17.2 Editing System Language
The System Language option allows a user to select the language of the Graphical User
Interface.

Select the desired language from the dropdown menu.

Figure 3-34. Edit System Language

3.17.3 Editing Alignment Crosshairs Intensity


The Alignment Crosshairs Intensity option allows a user to edit the brightness of thealignment crosshairs.



Select the Edit Alignment Crosshairs Intensity button on the Device Settings menu.

Figure 3-35. Edit Alignment Crosshairs Intensity
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Chapter 3: System Operation

3.17.4 Editing System Volume
The Edit Volume option allows a user with the appropriate security level to edit thesystem volume level.

Select the Edit Volume button on the Device Settings menu.

Figure 3-36. Edit Volume

3.17.5 Copying Treatment Data to USB

WARNING: The USB port can only be used when the system is not intreatment mode do not have items connected to the USB during
treatment.


Select the Copy Treatment Data to USB button on the Device Settings menu.

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Chapter 3: System Operation

Figure 3-37. Device Settings Transfer to USBInsert a USB device to a USB port and then press the Copy treatment data to USB
button. The system begins transferring the treatment data and shows a progress bar of thetransfer process as shown in the screen below.

Once complete press the Return button. The system will return you to the Device
Settings menu.

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3.17.6 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 3-38. Select Default Treatment Mode

Press the Checkmark button to continue.

Figure 3-39. Edit Default Treatment Parameters (Continuous & Pulsed)When finished entering treatment parameters, press the Checkmark button.

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Chapter 3: System Operation

Figure 3-40. Edit Default UV Pulse Parameters (Pulsed Only)

When finished entering treatment parameters, press the Checkmark button.

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4

Maintenance / Service

By definition, “maintenance” refers to those non-technical procedures an everyday operator must
perform to keep the system working properly. The word “service,” by contrast, refers to tasks thatare intended to be performed only by a qualified service representative.

4.1 Installation PolicyFor each new KXL System customer, your Avedro-authorized distributor provides a fullinitial installation and start-up of the system. Following initial installation and once thesystem is operating properly, the Avedro representative may also provide basic training
to a designated operator about the basic operation of the KXL System.

Consequently, this manual does not include any specific instructions relating toinstallation or set-up of the system. Per your service agreement, any further hardware
adjustment, other than what is specified for normal operation, should be performed by, orwith the guidance of, an Avedro-authorized distributor.

4.2 Customer MaintenanceIn general, there is no customer maintenance required for The KXL System. All technicalmaintenance 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.

4.3 Warranty Information
A Warranty is supplied separately with the purchasing information.

4.4 Service Contract Information
A service contract is available on all KXL Systems. The contract provides for regularlyscheduled maintenance and field upgrades. It also provides for any non-scheduled service
calls that may be necessary.

4.5 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 itdeems, was caused by the use of unauthorized materials.

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4.6 Trouble Shooting

The KXL System checks its status at start-up automatically. If the status is incorrect, thesoftware prevents the operator from initiating treatments when the system is in thenormal operating state.

Wireless Remote

The KXL System uses a remote control with replaceable batteries. If the batteries run
low the system will lose its connection with the remote and notify the user of the need tore-synchronize and will not allow the user to initiate a procedure. If the remotesynchronization is lost during a treatment the user will be prompted to determine if theywant to continue the treatment without the remote.

Figure 4-1. Remote Lost Synco

If 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 notsynchronized.

oIf the remote does not re-synchronize by pressing the “Sync” button, replace thebatteries.

o

If replacing the batteries does not allow the system to synchronize contact yourlocal Avedro Service Representative.

Internal Rechargeable Battery


The KXL system is supplied with a rechargeable battery, if the system does not appear tobe 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 thesystem is charging, if it is green it is fully charged.
oIf the indicator is green or yellow and the system still does not turn on contact
your local Avedro service representative.

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Chapter 4: Maintenance/Serviceo

If the indicator is orange wait until it turns yellow or green and try turning thesystem on, if it still does not turn on or the indicator does go yellow or green
within 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. Externalcleaning and disinfection ONLY is recommended. For disinfection purposes, use onlyisopropyl alcohol spray or preparations. Use small amounts of liquid and soft fiber-freewipes.

4.8 Cleaning the SystemUse a soft damp cloth to clean the system.

The exterior of the KXL System can be cleaned using a lint-free cloth dampened withdilute bleach, soapy water, or isopropyl alcohol.



A 70% alcohol or 10% chlorine bleach solution can also be used if necessary.



DO NOT submerse the system in liquid or pour liquid onto the system.

CAUTION: Remove the power supply cord from the main outlet and turn off the power switch
prior to any cleaning procedure.
CAUTION: Aggressive cleaning agents, especially those containing abrasives or aggressive solvents
can damage component surfaces.

The glass window of the beam aperture must not under any circumstances be in contact
with any of the aforementioned substances.



While cleaning the surfaces of the device, ensure that cleaning fluids do not seep insidethe device, as this leakage can damage the device.

4.9 Cleaning the ApertureCheck the beam aperture routinely prior to treatment.



Use special camera lens wipes or compressed air to remove dust and particles from theglass surface of the aperture.

4.10 Articulating Arm Adjustment
If the articulating arm does not hold the Optical Head in a fix vertical position contact yourlocal Avedro service representative.

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4.11 Performing Periodic MaintenanceInterval

Specific Task

AnnualCalibration by Avedro trained personnel.

4.12 Moving the System
The KXL is designed as a movable system within an office environment. If it ever provesnecessary 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.

4.13 Storing the SystemFollow all the storage temperature and humidity range specifications as listed in theSpecifications chapter 7.0.

Close all panels on the system to prevent dust and moisture from entering; this ismandatory.

Turn OFF all the components and the main power supply as well. Disconnect the power
cord physically from its electrical outlet.

Remove the batteries from the wireless remote.



Cover the touch screen LCD display and keyboard with its original cover or packaging toprevent any damage.



Do not disassemble any part of the system as this could cause misalignment or damage.

4.14 SoftwareShould the software become corrupted and fail to work correctly at some point, call yourlocal Avedro service representative. Software updates will only be carried out by Avedro
service representatives.

4.15 Identifying Risks Associated with Disposingof Waste Products

When disposing of waste products, follow all applicable local regulations.

4.16 Performing a Visible CheckCheck all components of the device routinely for damage or malfunction prior to eachtreatment.



Do not use a damaged or malfunctioning device. Use of such devices may harm the user
and/or patient.

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5

Equipment Classification

According to EN60601-1 Medical Device Electrical StandardooProtection against electrical shockClass 1 (external electrical power source)Internally powered equipment (internal battery operation)

Degree of protection against electric shockoDegree of protection against ingress of wateroDisinfect able device

Degree of protection for use in the presence of a flammable as aesthetic mixtureoCommon Devices IP20 (No protection against ingress of water)

Method of sterilization or disinfectiono

Not classified, equipment not provided with applied part

No protection

Use conditions
Continuous service

According to FCC Part 15, EN55011 and EN60601-1-2oClass B

According to EN60825-1 Safety of laser productionsoAlignment lasers are Class 1 Laser Product (<0.39 microwatts)

According to EN62471 Photobiological safety of lamps and lamp systemso

UVA LED is Risk Group 1

According to Annex II.3 of Directive 93/42/EEC as amended by 2007/47/ECoClass IIaKXL System Operator’s Manual,
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6

Symbol Library

Text Symbol

Symbol Illustration

Definition

1. No AP symbol in presenceof flammable anesthetics

Danger, Risk of Explosion. Not
for use

2. AC symbol

Alternating current

3. “I” in a bookAttention: Consult
ACCOMPANYING
DOCUMENTS

4. Ground symbol in circle

Protected earth (ground)

5. Power Switch

ON

6. Power Switch

OFF

7. Fuse symbol

Fuse

8. CE Mark

Conformity mark9. Manufacturer

Name and address of the
manufacturer

10. ! in a Triangle

Caution specific warning inoperators manual

11. Net Weight (kgs)

NW

Gross Weight (kgs)

GW

12. Umbrella with raindrops

WeightKeep Dry: Store protected frommoisture (symbol is with orwithout rain drops)

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Text Symbol

Symbol Illustration

13. Wine glass with crack on
itDefinition
Contents are fragile, handle
with careor
14. Two up arrows

Keep arrows on carton pointingup

15. Water drop in a box

Humidity limits (percentages
below symbol are theacceptable range for humidity)

16. Temperature limits

Temperature shipment limits

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7

Specifications

Specification

Description

Software Version

System 4.0.0

ElectricalBattery Powered: 12V 35 Ah SLALine voltages 100 – 240 volts AC, ± 10%
Current 2A
Single Phase
RMS, 50/60 Hz, ± 5%
Remote 2x AAA batteries

User accessible Fuses

250 V~ T2AL

Energy Delivery

UV Radiation3 – 45 mW/cm2
365 nmExternal Interfaces
Physical Dimensions
Weight (crated system)
Battery Life
(normal operating conditions)
Environmental Operating Conditions
Ambient temperature
Relative humidity
Atmospheric pressure
Transport and Storage Conditions

Ambient temperature
Relative humidity
Atmospheric pressure

USB 2.0
No larger than 60 x 60 x 150 cm3 (Length
x Width x Height)
NW 45 Kg
GW 120 Kg
16 hours
The system operates under the following
atmospheric conditions (no condensation).
+10 to +40 ºC
30% to 75%
900 to 1060 mbar
The instrument withstands the following
transport and storage conditions without
damage or performance deterioration.
-15 to +70 ºC
10% to 100% including condensation
500 to 1060 mbar

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