Avedro KXL System User manual

KXL Operator’s Manual Rev A
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Avedro, Inc.
KXL System
Operator’s Manual
Copyright 2017 All Rights Reserved
Printed in U.S.A.

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ML-00040
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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 2017.
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.
201 Jones Road
Waltham, MA 02451
EMERGO EUROPE
Prinsessegracht 20
2514 AP, The Hague
The Netherlands
Phone: [phone]
Fax: [phone]
0086

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Table of Contents
1Foreword........................................................................................................7
1.1 Intended Use of Manual............................................................................7
1.2 Intended Use / Indications for Use............................................................7
1.3 Design Change Disclaimer........................................................................7
1.4 Reproduction Disclaimer...................................................................................7
1.5 User Operation Assistance Statement................................................................7
1.6 Contraindications, Warnings and Cautions........................................................8
1.6.1 Contraindications ...................................................................................8
1.6.2 Warnings ................................................................................................8
1.6.3 Electrical Safety Warnings.....................................................................8
1.7 Radiation Safety Warnings ..............................................................................10
1.8 Patient Safety...................................................................................................11
1.9 Additional Safety Considerations....................................................................11
1.10 FCC Compliance Notice..................................................................................11
2Introduction.................................................................................................13
2.1 System Overview.............................................................................................13
2.1.1 Major Components...............................................................................14
3System Operation........................................................................................16
3.1 Touchpad/Keyboard Use .................................................................................16
3.2 UV Energy (Dose) ...........................................................................................19
3.3 Preparing the System .......................................................................................19
3.4 Important Steps before Turning on the System ...............................................20
3.5 Powering Up the System..................................................................................20
3.6 Existing Patient Data........................................................................................21
3.7 Add New Patient..............................................................................................21
3.8 Create New Treatment Plan.............................................................................22
3.8.1 Select Eye to Treat ...............................................................................23
3.8.2 Select Treatment Type .........................................................................23
3.8.3 Adjusting Treatment Parameters..........................................................24
3.9 Select Treatment Mode....................................................................................26
3.9.1 Continuous UV Mode ..........................................................................26
3.9.2 Pulsed UV Mode..................................................................................28
3.10 Starting a Treatment.........................................................................................28
3.10.1 Insert Treatment / RFID Activation Card ..........................................28
3.10.2 Single-use Activation Cards...............................................................29
3.10.3 Multi-use Activation Cards................................................................30
3.10.4 RFID card controlled limits................................................................32
3.10.5 Sync Alignment Remote ....................................................................33

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3.11 Preparing the Patient........................................................................................35
3.11.1 Applying Riboflavin...........................................................................36
3.12 Initiating Treatment .........................................................................................38
3.13 Monitoring Treatment......................................................................................39
3.14 Pausing a Treatment.........................................................................................40
3.15 Cancelling Mid Treatment...............................................................................41
3.16 Capturing Images.............................................................................................43
3.17 Treatment Complete.........................................................................................44
3.18 Reviewing Images............................................................................................45
3.19 Deleting Photos................................................................................................45
3.20 Patient Treatment Report.................................................................................48
3.20.1 Adding Notes to a Patient Treatment Report.....................................49
3.20.2 Exporting Treatment Report...............................................................50
3.20.3 Viewing a Treatment Report..............................................................53
3.21 Powering Down the System.............................................................................57
3.22 Using the System Settings Menu.....................................................................59
3.22.1 Service Settings..................................................................................60
3.22.2 Editing System Language...................................................................60
3.22.3 Editing Alignment Crosshairs Intensity.............................................60
3.22.4 Editing System Volume .....................................................................61
3.22.5 Export Service Log.............................................................................62
3.22.6 Editing Beep Intervals........................................................................63
3.22.7 Editing Camera White Balance..........................................................64
4Maintenance / Service.................................................................................66
4.1 Installation Policy ............................................................................................66
4.2 Customer Maintenance ....................................................................................66
4.3 Warranty Information ......................................................................................66
4.4 Service Contract Information...........................................................................66
4.5 Per Patient Disposables....................................................................................66
4.6 Trouble Shooting .............................................................................................67
4.7 Directions for Sterilization or Disinfection......................................................68
4.8 Cleaning the System ........................................................................................68
4.9 Cleaning the Aperture......................................................................................68
4.10 Articulating Arm Adjustment..........................................................................68
4.11 Moving the System..........................................................................................68
4.12 Storing the System...........................................................................................69
4.13 Software...........................................................................................................69
4.14 Identifying Risks Associated with Disposing of Waste Products....................70
4.15 Performing a Visible Check.............................................................................70
5Equipment Classification ...........................................................................71
6Symbol Library...........................................................................................72
7Specifications...............................................................................................74

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Table of Figures
Figure 2-1 Overview Illustration of System ............................................................................................ 14
Figure 2-2 System Illustrations with Callouts.......................................................................................... 15
Figure 2-3 Wireless Remote ................................................................................................................... 15
Figure 3-1 Power Switch......................................................................................................................... 20
Figure 3-2 Patient Database ................................................................................................................... 21
Figure 3-3 Enter Patient Information...................................................................................................... 22
Figure 3-4 Create New Treatment Plan .................................................................................................. 22
Figure 3-5 Select Eye .............................................................................................................................. 23
Figure 3-6 Select Treatment Type........................................................................................................... 24
Figure 3-7 Adjusting Parameters ............................................................................................................ 25
Figure 3-8 Adjusted Treatment Plan....................................................................................................... 26
Figure 3-9 Select Continuous Treatment Mode ...................................................................................... 27
Figure 3-10 Modifying Continuous Treatment Parameters..................................................................... 28
Figure 3-11 Insert Activation Card.......................................................................................................... 29
Figure 3-12 Reading Tag ......................................................................................................................... 30
Figure 3-13 Card Balance: Treatments Remaining .................................................................................. 30
Figure 3-14 Card Balance: 1 Treatment Remaining................................................................................. 31
Figure 3-15 No Treatments Left.............................................................................................................. 31
Figure 3-16 Invalid Treatment Parameters............................................................................................. 32
Figure 3-17 Invalid Treatment Parameters............................................................................................. 33
Figure 3-18 Sync Remote........................................................................................................................ 33
Figure 3-19 Sync process timed out........................................................................................................ 34
Figure 3-20 System Setup Status ............................................................................................................ 35
Figure 3-21 Prepare Treatment: Apply Riboflavin .................................................................................. 36
Figure 3-22 Align Crosshairs during induction ........................................................................................ 37
Figure 3-23 Remote Functions................................................................................................................ 38
Figure 3-24. Red Crosshairs X & Y Axes, Red Crosshairs Z Axis Alignment .............................................. 38
Figure 3-25 Start UV Treatment ............................................................................................................. 39
Figure 3-26 Treatment in Progress Screen.............................................................................................. 40
Figure 3-27 Treatment Paused Screen.................................................................................................... 41
Figure 3-28 Confirm Cancel Partial Treatment........................................................................................ 42
Figure 3-29 Treatment Cancelled Confirmation...................................................................................... 42
Figure 3-30 Partial Treatment Not Completed ....................................................................................... 43
Figure 3-31 Capturing Images................................................................................................................. 44
Figure 3-32 Treatment Complete Screen................................................................................................ 45
Figure 3-33 Select Trash to delete .......................................................................................................... 46
Figure 3-34 Select Yes to Delete ............................................................................................................. 47
Figure 3-35 Select Done ......................................................................................................................... 47
Figure 3-36 Sample Treatment Report ................................................................................................... 48
Figure 3-37 Comments Icon.................................................................................................................... 49
Figure 3-38 Comments Section............................................................................................................... 49
Figure 3-39 Exporting Treatment Report................................................................................................ 50
Figure 3-40 Insert USB............................................................................................................................ 51
Figure 3-41 USB Error............................................................................................................................. 51
Figure 3-42 No space left on USB ........................................................................................................... 52
Figure 3-43 Generating treatment report............................................................................................... 52

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Figure 3-44 Treatment report exported ................................................................................................. 53
Figure 3-45 Page 1 of 3: Treatment Details............................................................................................. 54
Figure 3-46 Page 2 of 3: Comments........................................................................................................ 55
Figure 3-47 Page 3 of 3: Photos .............................................................................................................. 56
Figure 3-48 Power Off ............................................................................................................................ 57
Figure 3-49 Power Off ............................................................................................................................ 58
Figure 3-50 Power Off Position .............................................................................................................. 58
Figure 3-51 Press Options button........................................................................................................... 59
Figure 3-52 System Settings Menu ......................................................................................................... 60
Figure 3-53 Edit System Language.......................................................................................................... 60
Figure 3-54 Alignment Crosshairs Intensity ............................................................................................ 61
Figure 3-55 Edit Volume......................................................................................................................... 62
Figure 3-56 Export Service log to USB..................................................................................................... 62
Figure 3-57 Export Service log in Progress.............................................................................................. 63
Figure 3-58 Select Beep Intervals ........................................................................................................... 64
Figure 3-59. Edit Camera White Balance ................................................................................................ 65
Figure 4-1 Alignment Remote Lost Sync ................................................................................................. 67
Figure 4-2 Moving System Configuration ............................................................................................... 69

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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 delivers a uniform, metered dose of UVA light to a targeted treatment
area for the intended use of illuminating the cornea during corneal cross-linking procedures
stabilizing cornea which have been weakened by disease or by refractive surgery.
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.
•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
•In this manual, Caution is defined as: a statement that alerts the user to the
possibility of a problem with the device associated with its use or misuse. Such
problems include device malfunction, device failure, damage to the device or
damage to other property. The caution statement includes the precaution that
should be taken to avoid the hazard.
•In this manual, Warning is defined as: a statement that alerts the user to the
possibility of injury, death, or other serious adverse reactions associated with the
use or misuse of the device.
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

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WARNING: To avoid the risk of shock this equipment must only be
connected to a supply mains with protective earth.
The system is designed for continuous operation using the external
connector.
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, is
performed only by qualified Avedro service personnel.
WARNING: Power down system and remove the wall plug 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.
The equipment must be positioned so that it is not difficult to remove the
power cord from the outlet.
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: 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.

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WARNING: The remote contains replaceable batteries; if system is not
going to be used for an extended period of time remove the batteries.
WARNING: No modification of this equipment is allowed.
WARNING: Use of not included accessories results in non-compliance of
the device
WARNING: System may be interfered with by other equipment even if that
equipment complies with CISPR Emissions requirements. See Table 5-1.
WARNING: System shall not be serviced or maintained while in use with a
Patient.
WARNING: MR Unsafe – Keep away from magnetic resonance imaging
equipment.
1.7 Radiation Safety Warnings
WARNING: Use only laser grade instruments in order to prevent reflected
UV radiation from smooth metallic surfaces.
WARNING: Do not use a damaged or malfunctioning device. Use of such
devices may harm the user and/or patient
WARNING: UV emitted from this product. Avoid eye and skin exposure to
unshielded products. Never direct the beam towards a person except for
therapeutic purposes.

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1.8 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.
1.9 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. 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.
1.10 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.

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•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 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 and camera. 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 power is selectable by
the user from 3 mW/cm2 to 45 mW/cm2 in 1 mW/cm2 increments. Total Energy is
selectable in 0.1 J/cm2increments on the user interface. However, actual limits to power
and energy are controlled by the RFID treatment card.
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. 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 and Camera
•KXL console with user interface
•Wireless remote control (with replaceable batteries)
•KXL Accelerated Crosslinking Treatment Kit (disposable supplied
separately)
•Hospital Grade AC power cable (Lockable/detachable)
•System Part Number: 110-01019
Figure 2-1 Overview Illustration of System

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Figure 2-2 System Illustrations with Callouts
Figure 2-3 Wireless Remote
User
Interface/Console
/RFID reader

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3System Operation
3.1 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 console.
Add new patient
button (Initial
screen)
Add patient information
prior to treating the patient
Options button
(Initial screen)
Displays system settings
and managing preset plans
Activation card
balance button
Displays balance on
treatment card
Manage clinic
preset plans
Modify parameters of
preset treatment plan
System Settings Device settings menu is
displayed
Service settings Ability to edit default
parameters
Create new
treatment plan to
begin (Patient
overview screen)
Starts preset or modified
treatment plan for 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
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 button
(various Clinical
Protocol screens
and Device
Settings screen)
Cancels all the entries on a
screen and returns to the
previous screen.
Export button Exports patient treatment
report to USB
Add comment
button (patient
overview screen)
Add notes to a patient
treatment report
Trash Can icon Delete photos taken during
treatment
Cancel Treatment
button
(various Clinical
Protocol screens)
Cancels a treatment
session for a patient.
Start timer button Starts treatment timer
Change treatment
type button
Changes treatment type

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Perform treatment
button(various
Clinical Protocol
screens)
Starts treatment
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.
Restore to factory
presets (manage
clinic preset plans) Presets restored to normal
parameters
CAUTION: Only qualified and experienced personnel shall operate the
KXL System.

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3.2 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.
•These options are selectable by the user during the treatment plan mode. See
section 3.8.3
•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*: 1 – 10.7 J/cm2
UV Power: 3 – 45 mW/cm2
* The user may select UV Energy in 0.1 J/cm2increments. The energy range
is controlled 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*: 1 – 10.7 J/cm2
UV Power: 6 – 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 J/cm2increments. The energy
range is controlled by the RFID card.
*Please reference Riboflavin Instructions for Use (IFU) for formulation
information.
3.3 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.
•When system is in use, keep head away from bright lights, such as positioning in
front of windows.

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•Check glass window of beam aperture for dust and dirt. See sections 4.7 and 4.8
for cleaning instructions.
3.4 Important Steps before Turning on the System
•The user is responsible for assuring that the KXL System is functioning properly
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.
3.5 Powering Up the System
•Turn ON the master power switch on the base of the KXL system, adjacent to the
power cord plug. This switch provides AC mains power to the KXL system.
•Please see section 3.21 for Power Down sequence instructions.
Figure 3-1 Power Switch
•Press and release the power-on button on the side of the KXL display screen. The
KXL System will begin a power-up sequence, loading the operating system and
all configuration and reference files.
NOTE: If there is a Start-up error, please note any error messages and contact
your distributor or Customer Service.