Avedro KXL System User manual

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

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 2012.
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 15
2513 BH, The Hague
The Netherlands
Phone: [phone]
Fax: [phone]
0470

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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
Chapter: 2 Introduction............................................................................................... 2-1
2.1 System Overview ........................................................................................... 2-1
2.1.1 Major Components............................................................................. 2-2
Chapter: 3 System Operation...................................................................................... 3-1
3.1 Charging the KXL Battery............................................................................. 3-1
3.2 Touchpad/Keyboard Use ............................................................................... 3-1
3.3 UV Dose......................................................................................................... 3-3
3.4 Preparing the System ..................................................................................... 3-3
3.5 Important Steps before Turning on the System ............................................. 3-3
3.6 Powering Up the System................................................................................ 3-3
3.7 Setting Treatment Settings............................................................................. 3-4
3.8 Starting Treatment ......................................................................................... 3-6
3.8.1 Single-use disposables........................................................................ 3-7
3.8.2 Multi-use disposables......................................................................... 3-7
3.9 Preparing the Patient .................................................................................... 3-10
3.10 Initiating Treatment ..................................................................................... 3-11
3.11 Monitoring Treatment.................................................................................. 3-12
3.12 Stopping a Treatment................................................................................... 3-12
3.13 Treatment Complete..................................................................................... 3-13
3.14 Pausing or Canceling a Treatment ............................................................... 3-14
3.15 Powering Down the System......................................................................... 3-16
3.16 Using the Device Settings Menu.................................................................. 3-18
3.16.1 Advanced Settings.......................................................................... 3-18
3.16.2 Editing Alignment Crosshairs Intensity ......................................... 3-19
3.16.3 Editing System Volume ................................................................. 3-19
3.16.4 Copying Treatment Data to USB ................................................... 3-20
3.16.5 Editing Default Treatment Parameters Screen ............................... 3-21

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Chapter: 4 Maintenance / Service............................................................................... 4-1
4.1 Installation Policy .......................................................................................... 4-1
4.2 Customer Maintenance .................................................................................. 4-1
4.3 Warranty Information .................................................................................... 4-1
4.4 Service Contract Information......................................................................... 4-1
4.5 Per Patient Disposables.................................................................................. 4-1
4.6 Trouble Shooting ........................................................................................... 4-2
4.7 Directions for Sterilization or Disinfection.................................................... 4-3
4.8 Cleaning the System ...................................................................................... 4-3
4.9 Cleaning the Aperture .................................................................................... 4-3
4.10 Articulating Arm Adjustment ........................................................................ 4-3
4.11 Performing Periodic Maintenance ................................................................. 4-4
4.12 Moving the System ........................................................................................ 4-4
4.13 Storing the System ......................................................................................... 4-4
4.14 Software ......................................................................................................... 4-4
4.15 Identifying Risks Associated with Disposing of Waste Products.................. 4-4
4.16 Performing a Visible Check........................................................................... 4-4
Chapter: 5 Equipment Classification ......................................................................... 5-1
Chapter: 6 Symbol Library ......................................................................................... 6-1
Chapter: 7 Specifications............................................................................................. 7-1

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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. Startup Screen ...............................................................................................3-4
Figure 3-2. Induction Period Screen................................................................................3-4
Figure 3-3. Treatment Parameters Screen........................................................................3-5
Figure 3-4. Confirm Treatment Parameters Screen.........................................................3-5
Figure 3-5. Reading Disposables.....................................................................................3-6
Figure 3-6. Reading Tag Screen ......................................................................................3-7
Figure 3-7. Treatments Remaining..................................................................................3-7
Figure 3-8. Final Treatment.............................................................................................3-8
Figure 3-9. No Treatments Remaining ............................................................................3-8
Figure 3-10. System Setup Status....................................................................................3-9
Figure 3-11. Prepare Patient Screen...............................................................................3-10
Figure 3-12. Align Crosshairs during induction............................................................3-11
Figure 3-13. Induction Complete...................................................................................3-11
Figure 3-14. Treatment Screen ......................................................................................3-12
Figure 3-15. Treatment Paused Screen..........................................................................3-12
Figure 3-16. Treatment Complete Screen......................................................................3-13
Figure 3-17. Initial Confirm Cancel Session Screen .....................................................3-14
Figure 3-18. Confirm Cancel Partial Treatment............................................................3-14
Figure 3-19. Partial Treatment Information...................................................................3-15
Figure 3-20. Power Off..................................................................................................3-16
Figure 3-21. Power Off Position....................................................................................3-17
Figure 3-22. KXL System Plug .....................................................................................3-17
Figure 3-23. Device Settings Menu...............................................................................3-18
Figure 3-24. Edit Alignment Crosshairs Intensity.........................................................3-19
Figure 3-25. Device Settings Edit Volume....................................................................3-19
Figure 3-26. Device Settings Transfer to USB..............................................................3-20
Figure 3-27. Edit Default Treatment Parameters...........................................................3-21
Figure 4-1. Remote Lost Sync.........................................................................................4-2

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1 Forward
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 delivers a uniform, metered dose of UVA light to a targeted treatment area for the
intended use of illuminating the cornea during corneal crosslinking procedures stabilizing cornea
which have been weakened by disease or by refractive surgery.
1.3 Design Change Disclaimer
Due to design changes and product improvements, information in this manual is subject to
change without notice. Avedro, Inc. (hereafter called “Avedro”) reserves the right to
change product design at any time without notice, which may subsequently affect the
contents 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 corresponds
with the shipped KXL System.
The computer display screens depicted in this manual are representative only. Depending
on 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, 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.

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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:
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 women
Children
1.6.2 Warnings
Physicians should evaluate the potential benefits in patients with the following conditions:
Herpes simplex, herpes zoster keratitis, recurrent corneal erosion, corneal dystrophy
Epithelial healing disorders
1.6.3 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 be
connected to a supply mains with protective earth.
Even with 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.

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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.
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: Never look directly into the UV light beam. Never direct the
beam towards a person except for therapeutic purposes.
WARNING: The remote contains replaceable batteries; if system is not
going 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 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.

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1.8 Additional Safety Considerations
UV irradiance of the KXL System is calibrated by the manufacturer and must be checked
annually. Any modification of the system's external light beam by means of optical
elements is strictly prohibited.
Plastic instrumentation such as speculums or eye shields may be damaged when impacted
by the UV beam, possibly resulting in product degradation. 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 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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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 crosslinking. 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/cm2to 45 mW/cm2.
A fixed aperture mounted in the UVA irradiation beam path is used to produce a uniform circular
area 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 an
internal drive system. Treatment time is selectable by the user from 1 minute to 30 minutes in
1 second increments and power is selectable from 3 mW/cm2 to 45 mW/cm2 in 1 mW/cm2
increments. Power/time combinations that would result in a surface exposure of more than
10 J/cm2 or more are prohibited by the software.
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 (induction period, UV exposure time, UV intensity, and beam diameter) 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 Label

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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.
If using the internal rechargeable battery, at the end of each business day or when not in
use, the KXL should be connected to grounded supply mains to allow charging of the
battery pack.
The change of the battery is identified by a light located on the column of the KXL, the
following describes the battery charge.
oOrange –low, charging
oYellow –charging
oGreen –fully charged
NOTE: if the battery does not appear to be holding a charge or charging please
contact your local Avedro Service Representative.
NOTE: the battery pack on the system should last for 16 hours during normal operation.
The software system will notify the user when the battery needs to be charged. The KXL
is designed to prohibit treatment if there is not sufficient battery power to perform a
treatment. (See chapter 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 to
the 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.

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Touchpad Key
Icon
Description/Function
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 to Treatment
button
(Confirm Cancel
Session screen)
Cancels the Cancel Session
command and returns to the
Treatment 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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3.3 UV Dose
The UV irradiance dose is the product of the intensity of the irradiance and the exposure
time. Both intensity of the irradiance and the exposure time are adjustable and displayed.
The system tracks treatment time, intensity of irradiance and total dose during treatment.
NOTE - The system's parameters are:
Induction Period: 1 –30 minutes
Irradiance: 3 –45 mW/cm2
Exposure Time: 1 –30 minutes
The maximum dose is 10 J/cm2
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 to
secure the device’s position.
Make sure the system is turned ON.
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.
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.
The KXL System begins a power-up sequence, loading the operating system and all
configuration and reference files.

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Figure 3-1. Startup Screen
Press the Power Off button to turn the system off. If there is a Start-up error, please note
any error messages and contact your distributor or Customer Service immediately.
3.7 Setting Treatment Settings
To begin patient treatment, press the Start New Treatment button.
Specify the desired induction period (1 –30 min) for the patient.
When finished entering parameters, press the Checkmark button.
Figure 3-2. Induction Period Screen
NOTE: Default treatment parameters will auto-populate fields but are adjustable.
Defaults settings can be changed (see section 3.16.5, Editing Default Treatment
Parameters Screen).

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Figure 3-3. Treatment Parameters Screen
Specify the desired treatment parameters, in turn, for the patient as follows:
oUV Treatment Time (1 –30 minutes)
oUV Power (3 –45 mW/cm2)
NOTE: Total Energy will be displayed in the lower orange box. The maximum
permissible total Energy density is 10 J/cm2.
When finished entering treatment parameters, press the Checkmark button.
Figure 3-4. Confirm Treatment Parameters Screen
Confirm the specified treatment parameters by pressing the Checkmark; if the treatment
parameters are not correct press the X and then re-enter the desired treatment parameters.

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