Avedro, Inc.
KXL System
Operator’s Manual

Copyright 2017
Printed in U.S.A.
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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 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 202514 AP, The Hague
The Netherlands
Phone: +31.70.345.8570
Fax: +31.70.346.7299

0086

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Table of Contents
1

1.4
1.5
1.6

1.7
1.8
1.9
1.10
2
2.1
3
3.1
3.2
3.3
3.4
3.5
3.6
3.7
3.8

3.9

3.10

Foreword ........................................................................................................7
1.1 Intended Use of Manual ............................................................................7
1.2 Intended Use / Indications for Use ............................................................7
1.3 Design Change Disclaimer ........................................................................7
Reproduction Disclaimer ...................................................................................7
User Operation Assistance Statement ................................................................7
Contraindications, Warnings and Cautions........................................................81.6.1 Contraindications ...................................................................................8
1.6.2 Warnings ................................................................................................8
1.6.3 Electrical Safety Warnings .....................................................................8
Radiation Safety Warnings ..............................................................................10
Patient Safety ...................................................................................................11
Additional Safety Considerations ....................................................................11
FCC Compliance Notice ..................................................................................11
Introduction .................................................................................................13
System Overview .............................................................................................132.1.1 Major Components ...............................................................................14
System Operation ........................................................................................16
Touchpad/Keyboard Use .................................................................................16
UV Energy (Dose) ...........................................................................................19
Preparing the System .......................................................................................19
Important Steps before Turning on the System ...............................................20
Powering Up the System ..................................................................................20
Existing Patient Data........................................................................................21
Add New Patient ..............................................................................................21
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
Select Treatment Mode ....................................................................................26
3.9.1 Continuous UV Mode ..........................................................................26
3.9.2 Pulsed UV Mode ..................................................................................28
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
3.12
3.13
3.14
3.15
3.16
3.17
3.18
3.19
3.20

3.21
3.22

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
5
6
7

Preparing the Patient ........................................................................................35
3.11.1 Applying Riboflavin ...........................................................................36
Initiating Treatment .........................................................................................38
Monitoring Treatment ......................................................................................39
Pausing a Treatment .........................................................................................40
Cancelling Mid Treatment ...............................................................................41
Capturing Images .............................................................................................43
Treatment Complete.........................................................................................44
Reviewing Images ............................................................................................45
Deleting Photos ................................................................................................45
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
Powering Down the System .............................................................................57
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
Maintenance / Service .................................................................................66
Installation Policy ............................................................................................66
Customer Maintenance ....................................................................................66
Warranty Information ......................................................................................66
Service Contract Information ...........................................................................66
Per Patient Disposables ....................................................................................66
Trouble Shooting .............................................................................................67
Directions for Sterilization or Disinfection......................................................68
Cleaning the System ........................................................................................68
Cleaning the Aperture ......................................................................................68
Articulating Arm Adjustment ..........................................................................68
Moving the System ..........................................................................................68
Storing the System ...........................................................................................69
Software ...........................................................................................................69
Identifying Risks Associated with Disposing of Waste Products ....................70
Performing a Visible Check .............................................................................70
Equipment Classification ...........................................................................71
Symbol Library ...........................................................................................72
Specifications ...............................................................................................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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1 Foreword
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 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 treatmentarea 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 issubject 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 dateand 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 electronicallytransmitted 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 yourlocal 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 ofuse 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 womenChildren

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 thepossibility of a problem with the device associated with its use or misuse. Suchproblems include device malfunction, device failure, damage to the device or
damage to other property. The caution statement includes the precaution thatshould be taken to avoid the hazard.
• In this manual, Warning is defined as: a statement that alerts the user to thepossibility of injury, death, or other serious adverse reactions associated with theuse 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 electricalequipment 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 beconnected 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. Ensurethat 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 thepower cord plug and pull it from the outlet to disconnect.
The equipment must be positioned so that it is not difficult to remove thepower 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 fromthe wall outlet.
WARNING: Do not use the instrument near water and be careful not tospill liquids on any part of it.

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.
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WARNING: The remote contains replaceable batteries; if system is notgoing 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 ofthe 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.
WARNING: Do not use a damaged or malfunctioning device. Use of suchdevices may harm the user and/or patient
WARNING: UV emitted from this product. Avoid eye and skin exposure to

1.7unshielded
Radiation
SafetyWarnings
products.
Neverdirect the beam towards a person except fortherapeutic purposes.

WARNING: Use only laser grade instruments in order to prevent reflected
UV radiation from smooth metallic surfaces.

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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 thatthe 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 thesupervision 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 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. Thisequipment generates, uses, and can radiate radio frequency energy and, if not installed andused in accordance with the instruction manual, may cause harmful interference to radio
communications. However, there is no guarantee that interference will not occur in aparticular 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 towhich 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 tomeet FCC emission limits. Proper cables and connectors are available from Avedro.
Avedro is not responsible for any radio or television interference caused byunauthorized changes or modifications to this equipment. Unauthorized changes ormodifications 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 intermolecularbonds in corneal collagen, stiffening the cornea through cross-linking. UV flux andirradiation 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 presetby 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
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 isselectable in 0.1 J/cm2 increments on the user interface. However, actual limits to powerand 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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UserInterface/Console/RFID reader

Figure 2-2 System Illustrations with Callouts

Figure 2-3 Wireless Remote
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3 System 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 settingsand managing preset plans

Activation cardbalance button

Displays balance on
treatment card

Manage clinicpreset plans

Modify parameters ofpreset treatment plan

System Settings

Device settings menu isdisplayed

Service settings

Ability to edit default
parameters

Create newtreatment plan tobegin (Patient
overview screen)

Starts preset or modified
treatment plan for patient

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Touchpad Key

Icon

Description/Function

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 ascreen and returns to theprevious screen.

Checkmark button(various ClinicalProtocol screensand Device
Settings screen)

Directs the system toaccept the current screen
entries and to proceed to
the next step.

Cancel button(various ClinicalProtocol screensand Device
Settings screen)

Cancels all the entries on ascreen and returns to theprevious 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 ClinicalProtocol screens)

Cancels a treatment
session for a patient.

Start timer button

Starts treatment timer

Change treatment
type button

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Perform treatment
button(various
Clinical Protocol
screens)

Starts treatment

Return toTreatment button(Confirm Cancel
Session screen)

Cancels the Cancel
Session command andreturns 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:
UV Energy*:
UV Power:

1 second – 30 minutes
1 – 10.7 J/cm2
3 – 45 mW/cm2* The user may select UV Energy in 0.1 J/cm2 increments. 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:
UV Energy*:
UV Power:
UV ON Time:UV OFF Time:

1 second – 30 minutes
1 – 10.7 J/cm2
6 – 45 mW/cm2
1.0 – 4.0 Seconds
1.0 – 4.0 Seconds* The user may select UV Energy in 0.1 J/cm2 increments. 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 thecasters 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 infront 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:o Inspect the device, accessories, and connecting cables for visible damage.
o Take 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 thepower 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 andall configuration and reference files.
NOTE: If there is a Start-up error, please note any error messages and contact
your distributor or Customer Service.

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Figure 3-2 Patient Databaseo The Patient database stores: Previously treated patients
 Untreated patients with saved treatment plans New patients with no assigned treatment plans

3.6 Existing Patient Data•

To search database for an existing patient, tap in the “search patients” box and a
keyboard will generate. Type patients name in and results will populate.

3.7 Add New Patient••••

To begin adding a new patient, select “Add new patient”
If “anonymous patient” is selected, last name field will populate as anonymousand an incrementing number will populate in “first name” field.
Once the patient information is completed, the “OK” button will become
available.
Patients can be added at any time and are saved in the database once “OK” ispressed.

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Figure 3-3 Enter Patient Information

3.8 Create New Treatment Plan•••

Select patient to treat from patient database
Press “Create new treatment plan” to begin
Treatment plans can be made and saved prior to patients arrival

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3.8.1 Select Eye to Treat••

Choose the eye you wish to treat: OD or OS
When eye is selected, the field will be outlined in blue

Figure 3-5 Select Eye

3.8.2 Select Treatment Type
•

•
•
•

The system is pre-programmed with five preset treatment plans:o Epi-On Accelerated CXLo Epi-Off Accelerated CXLo Conventional CXLo LASIK Xtra
o CustomSaved formulations and parameters will auto-populate based on the chosen
treatment plan.
Any of the pre-set plans can be edited to change energy dose, irradiance orother treatment parameters then saved for future use.
Select “Custom” treatment plan to create a new, custom plan.

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•Once a pre-set treatment plan is chosen or a customizable treatment plan issaved, select “Next” to proceed.

Figure 3-6 Select Treatment Type3.8.3 Adjusting Treatment Parameters•

Review and confirm all treatment parameters within selected treatment plan. To
edit individual parameters, press within the specific parameter and use thearrows to increase or decrease the desired field.

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Figure 3-7 Adjusting Parameters•

When finished editing parameters, select “Save for later treatment” for futureuse, or “Save and perform treatment” for immediate use.

•

If parameters were adjusted within any of the four presets, “Modified” will be
displayed next to chosen treatment plan.

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Figure 3-8 Adjusted Treatment Plan

3.9 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.

3.9.1 Continuous UV Mode
To select Continuous treatment mode, select “Continuous” from the drop down menu to
the right of “UV Delivery”.

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Figure 3-9 Select Continuous Treatment Mode•

Enter the desired UV treatment parameters:o Total Energy*o UV Power (3 – 45 mW/cm2)
NOTE: UV irradiation time is automatically calculated and displayed.
* The user may select UV Energy in 0.1 J/cm2 increments. The energy range
is controlled by the RFID card.

•

Review and confirm all treatment parameters by selecting “Save for later
treatment” or “Save and perform treatment”; if the treatment parameters are notcorrect, select wrongful parameters and then re-enter the desired treatment
parameters and save.

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Figure 3-10 Modifying Continuous Treatment Parameters3.9.2 Pulsed UV Mode•

To select Pulsed treatment mode, select “Pulsed” from the drop down menu to theright of “UV Delivery”.

3.10

Starting a Treatment
o Choose patient from patient database.
o If a treatment plan was just created, select “Perform treatment”.

3.10.1•

Insert Treatment / RFID Activation Card
Insert the activation card all the way into the RFID slot and leave in place.

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Figure 3-11 Insert Activation Card

3.10.2Single-use Activation Cards•

Keep card in place until read is complete.

•

The “OK” button will illuminate when it is OK to remove the card.

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Figure 3-12 Reading Tag

3.10.3

Multi-use Activation Cards•

Once a multi-use activation card has been inserted, the display will show thenumber of treatments remaining on the card.

•

Activation card can either be removed or remain in the RFID slot and stored
for next use.

Figure 3-13 Card Balance: Treatments Remaining•

If treatment card only has one treatment left, the system will inform user to“Replace card before next treatment”.

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Figure 3-14 Card Balance: 1 Treatment Remaining•

If no treatments remain on the card, the system alerts the user to insert a
different card or to save the treatment for later.

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3.10.4•

RFID card controlled limits
If the user has programmed a UV Energy range that is outside the allowablevalue(s) controlled by the RFID card the following message will appear after“perform treatment” has been selected.

Figure 3-16 Invalid Treatment Parameters•

Go Back to Treatment Parameters to enter an appropriate parameter.

•

If the user has the treatment card inserted while programming treatment
parameters that are outside the allowable value(s) controlled by the RFID card
the following message will appear and “Perform treatment” will unable to be
selected.

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Figure 3-17 Invalid Treatment Parameters3.10.5

Sync Alignment Remote

Figure 3-18 Sync Remote
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The Sync alignment remote message will be visible on the screen for
15 seconds
o When the timer gets to three seconds, it will beep for the remaining
seconds
o If the sync button is not pressed within the timeframe, a message
stating the sync process has timed out. However, you may choose to“Continue without remote”.
oFigure 3-19 Sync process timed out

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Figure 3-20 System Setup Status•

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.

NOTE: The KXL system performs an internal self-test prior to eachtreatment to verify proper UVA calibration. The internal self-test uses a
redundant set of optical sensors to ensure that accurate levels of UVA will
be delivered for each treatment. If the internal self-test fails, an error
message will be generated and the treatment cannot proceed. If this occurs,
contact your distributor or Customer Service immediately.

3.11 Preparing the Patient•

Ensure that the patient is lying flat or reclined on a patient table or chair. His
or her head should rest in a headrest.

•

Adjust the table or chair and headrest so that the patient can rest comfortably
for the duration 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).

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3.11.1•••

Applying Riboflavin

Apply riboflavin drops on the eye per clinical protocol.
Red lasers will turn on only 30 seconds before the induction period is over.
When lasers turn on, align the crosshairs over eye to be treated.

Figure 3-21 Prepare Treatment: Apply Riboflavin
CAUTION: Riboflavin (vitamin B2) is not a part of the KXL Systemdescribed in this manual. For details , please refer to the Riboflavin’s
Directions for Use.

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Figure 3-22 Align Crosshairs during induction
NOTE: Once the Riboflavin is applied to the eye, Start the induction by pressing the“Start UV Treatment” button.
•

KXL has two alignment lasers.
o Red crosshair for X and Y axis positioning.
o A second Red crosshair for Z axis positioning.
o Crosshairs may differ in appearance. They may appear thicker, thinner,
longer or shorter.

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/Yaxes’ Red crosshairs are aligned to the center of the pupil.

•

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

•

Fine tune the alignment as needed using the wireless remote or arrows on the
motion stage.

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Figure 3-23 Remote Functions

Figure 3-24. Red Crosshairs X & Y Axes, Red Crosshairs Z Axis Alignment

3.12 Initiating Treatment•

When the Induction Time is complete, Select the “Start UV Treatment” button toinitiate treatment.

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Figure 3-25 Start UV Treatment

WARNING: Start treatments only after the photosensitizer is applied.
CAUTION: UV light is emitted when the Avedro logo on the optical head flashes
color from blue to green.
WARNING: Make sure that the KXL System and the patient’s table orchair are secured and not moved after alignment and during treatment.

3.13 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 or arrows on motion
stage.

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Figure 3-26 Treatment in Progress Screen
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 thetreatment.

•

Patients should remain still during the treatment.

3.14 Pausing 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 be switched OFF by pushing the Pause button.

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Figure 3-27 Treatment Paused Screen•

To cancel or resume treatment select “Cancel Treatment” or “Resume UV
treatment” respectively. See section 3.14 if canceling a session.

3.15 Cancelling Mid Treatment•

If treatment is cancelled mid treatment, screen displays with Confirm cancelling
treatment before it is complete•

To cancel session, select “Yes”.

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Figure 3-28 Confirm Cancel Partial Treatment•

If cancelling treatment was confirmed, the screen displays confirmation

Figure 3-29 Treatment Cancelled Confirmation•

Once cancelled, the screen displays Partial Treatment Information.

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Figure 3-30 Partial Treatment Not Completed

3.16 Capturing Images•••

Images can be taken at each stage throughout the treatment process.
To capture an image, select the camera button in the top right hand corner of eye
image.
The image is automatically saved and available for review post treatment.

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Figure 3-31 Capturing Images

3.17 Treatment Complete
At the completion of a treatment the Total Treatment Parameters will be displayed andthe screen will show Treatment complete.

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Figure 3-32 Treatment Complete Screen•

If treatments are complete, select “Done” and Power OFF the system using the“Power Off” button on the Main Screen.

•

Carefully remove the device from the patient area.

•

Follow up with normal post op care.

•

Remove speculum.

3.18 Reviewing Images•••

All images taken throughout treatment are available for review post treatment.
Select “View photos” to enter photo gallery.

3.19 Deleting Photos••

Photos taken throughout treatment can be deleted.
Select the trash icon to delete a photo.

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Figure 3-33 Select Trash to delete• Once a photo is selected for deletion, select “yes” to delete photo or select “no”
to keep the image.
• Once deletion is confirmed, photo will not be retrievable.

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Figure 3-34 Select Yes to Delete•

Select “Done” to confirm which photos will be displayed in thetreatment report.

Figure 3-35 Select DoneKXL Operator’s Manual Rev A
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3.20 Patient Treatment Report
•

•
•
•

A treatment report is generated containing patient information,
treatment details, photos taken throughout treatment and a notes
section.
Treatment reports are generated even if treatments are paused orcancelled.
A green checkmark will be listed next to completed phases.
A red “X” mark will be listed next to incomplete phases.

Figure 3-36 Sample Treatment ReportKXL Operator’s Manual Rev A
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3.20.1 Adding Notes to a Patient Treatment Report••

From the Patient Database screen, select the patients name.
Press the message icon to enter comments about the patient’s
treatment.

Figure 3-37 Comments Icon•

Keyboard will become available to make comments to the patient’s
report.

Figure 3-38 Comments Section

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3.20.2

Exporting Treatment Report••

Select “Export treatment report” to save report to a USB stick.
Report will be exported as PDF.

Figure 3-39 Exporting Treatment Report••

The screen will prompt to insert USB drive.
Avedro does not supply USB drive for storing patient data

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Figure 3-40 Insert USB•

If the USB is full or the system is unable to read the USB, a message indicating theerror will be displayed.

Figure 3-41 USB Error
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Figure 3-42 No space left on USB•

Once USB is entered, “Generating treatment report” message will appear

Figure 3-43 Generating treatment report•

When Treatment report is exported, a confirmation message will appear

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Figure 3-44 Treatment report exported

3.20.3

Viewing a Treatment Report• Full treatment report can be reviewed on system or USB (if exported).
• Any photos or comments added will be included in report.

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Figure 3-45 Page 1 of 3: Treatment Details

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Figure 3-46 Page 2 of 3: Comments

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Figure 3-47 Page 3 of 3: Photos

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3.21 Powering Down the System•

Select the “Power Off” on the console.

Figure 3-48 Power Off•

Confirm powering off system

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Figure 3-49 Power Off••

Wait for the software to shut down - the screen will be blank.
After the screen is blank and software shuts down, turn the master power switch
to the “Off” position.

Figure 3-50 Power Off PositionKXL Operator’s Manual Rev A
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3.22 Using the System Settings Menu•

With the Patient database displayed, press the “Options” button, then press‘System Settings”

Figure 3-51 Press Options button

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Figure 3-52 System Settings Menu

3.22.1•Service Settings

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

3.22.2

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 menu.

Figure 3-53 Edit System Language

3.22.3

Editing Alignment Crosshairs Intensity•

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

•

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

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Figure 3-54 Alignment Crosshairs Intensity

3.22.4

Editing System Volume•

The Edit Volume option allows a user to edit the system volume level.

•

Select the Audio Volume button on the Device Settings menu.

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Figure 3-55 Edit Volume

3.22.5•

Export Service Log

Select the Export Service log button on the Device Settings menu.

Figure 3-56 Export Service log to USB•

Insert a USB drive to the USB port. The system automatically begins transferring
the service log and shows a progress bar of the transfer process as shown in thefollowing figure.

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Figure 3-57 Export Service log in Progress•

Once complete press the “OK” button. The system will return you to the System
Settings menu.

3.22.6

Editing Beep Intervals•

The Editing beep intervals option allows a user to set the default time between
audible beeps while induction is in progress.

•

Click the minute and second icons to increase or decrease time, then press save.

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Figure 3-58 Select Beep Intervals

3.22.7•

Editing Camera White Balance

The Camera White Balance option allows a user to change the light conditions
within the console. Typical office lighting is under 5000K. As a result, the default
setting is Tungsten 2800K. If a different light source is used, it may be useful toedit the white balance condition.

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Figure 3-59. Edit Camera White Balance

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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,” bycontrast, refers to tasks that are intended to be performed only by a qualified service
representative.

4.1

Installation Policy•

For each new KXL System customer, an Avedro trained or authorized personnel
provides a full initial installation and start-up of the system. Following initialinstallation and once the system is operating properly, this Avedro representative
may also provide basic training to a designated operator about the basic operationof 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, or with the guidance of, an Avedro-authorized distributor.

4.2 Customer Maintenance•In general, there is no customer maintenance required for The KXL System. All
technical maintenance 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 forregularly scheduled service and field upgrades. It also provides for any nonscheduled 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 withyour KXL System. Avedro shall not be liable for damage to or malfunction of
the system, which it deems, was caused by the use of unauthorized materials.

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4.6 Trouble Shooting•

The KXL System checks its status at start-up automatically. If the status isincorrect, the software prevents the operator from initiating treatments.

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 ofthe need to re-synchronize and will ask user to “Continue without remote” . If theremote synchronization is lost during a treatment the user will be prompted todetermine if they want to continue the treatment without the remote.

Figure 4-1 Alignment Remote Lost Sync
o 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 persecond then it is not synchronized.
o If the remote does not re-synchronize by pressing the “Sync” button,
replace the batteries.
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o If replacing the batteries does not allow the system to synchronize 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.
External cleaning and disinfection ONLY is recommended. For disinfection
purposes, use only isopropyl alcohol spray or preparations. Use soft fiber-freewipes.

4.8 Cleaning the System•

Use a soft damp cloth to clean the system.

•

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

•

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

•

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

CAUTION: Power down the system and remove the power supply cordfrom the main outlet prior to any cleaning procedure.
CAUTION: The glass window of the beam aperture must not under any
circumstances be in contact with any aggressive cleaning agents.
•

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

•

Use a lint-free cloth dampened with isopropyl alcohol to clean the remote control.

4.9 Cleaning the Aperture•

Check the beam aperture routinely prior to treatment.

•

Use 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 your local Avedro service representative.

4.11 Moving the System•

The KXL is designed as a movable system within an office environment. If it everproves necessary to transport or ship the KXL System, for any reason, contact

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your local Avedro representative. Packing and transporting the system should be
performed only by Avedro trained and authorized personnel.
•

Prior to moving the KXL System from one room to another, the monitor should
be moved sideways and the optics head should be positioned close to the cart
handle with the elbow protruding at the back. The system can then be easily
pushed by the cart handle through the door frame.

Elbow at the back
UI monitor to the side
UV optical head nearhandleFigure 4-2 Moving System Configuration

4.12 Storing the System•

Follow all the storage temperature and humidity range specifications as listed in
the Specifications chapter 7.0.

•

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

•

Turn OFF all the components and switch off the master power switch as well.
Disconnect the power cord from its electrical outlet Remove the batteries from thewireless remote.

•

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

4.13 Software•

Should the software become corrupted and fail to work correctly, call your local
Avedro service representative. Software updates will only be carried out by
Avedro service representatives.

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4.14 Identifying Risks Associated with Disposing of Waste
Products•

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

4.15 Performing a Visible Check•

Check all components of the device routinely for damage or malfunction prior toeach treatment.

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5 Equipment Classification
According to EN60601-1 Medical Device Electrical StandardoProtection against electrical shockoo

Degree of protection against electric shock

Not classified, equipment not provided with applied part

Ingress protection: IP20

Method of sterilization or disinfectionoDisinfect-able device

Degree of protection for use in the presence of a flammable as aesthetic
mixtureoClass 1 (external electrical power source)

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 ProductAccording to EN62471 Photobiological safety of lamps and lamp systemsoIEC 62471:2006 Risk Group 2

oEN 62471:2008 Risk Group 3o

UVA LED is Risk Group 3

According to Annex II.3 of Directive 93/42/EECoClass IIaKXL Operator’s Manual Rev A
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6 Symbol Library
Text Symbol

Symbol Illustration

Definition

1. No AP symbol inpresence of flammableanesthetics

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. Ingress Protection Symbol

IP20

6. Power button

Ingress Protection solids
under 12.5 mm and noprotection against water)
Standby

7. Power Switch

ION

8. Power SwitchOOFF

9. CE Mark

Conformity mark10. Manufacturer

Name and address of the
manufacturer

11. ! in a Triangle

Caution specific warning inoperators manual

12. Net Weight (kgs)
Gross Weight (kgs)

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NW
GW

WeightText Symbol

Symbol Illustration

Definition

13. Umbrella with raindrops

Keep Dry: Store protectedfrom moisture (symbol is withor without rain drops)

14.

Contents are fragile, handle
with careor
15. Two up arrows

Keep arrows on carton
pointing up

16. Water drop in a box

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

17. Operating Temperature
limitsOperating Temperature
shipment limits

18. Storage Temperature
limitsStorage Temperature limits

19. MR crossed in a circle

MR Unsafe – Keep away frommagnetic resonance imaging(MRI) equipment

20. Storage Pressure limits

Storage Atmospheric pressure
limits

21. Operating Pressure
limitsOperating Atmosphericpressure limits

22. Signal emitted

RF transmitted through device

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7 Specifications
Specification

Description

ElectricalLine voltages 100 – 240 volts AC
Current 2A – 1A
Single Phase
RMS, 50/60 Hz
Remote 2x AAA batteries

List of cables and Accessories

Wireless Remote
Hospital Grade AC power cable(Lockable/Detachable)

Energy Delivery

UV Radiation3 – 45 mW/cm2
365 nmUVA LED Light Source

UV Radiation
365 nmExternal Interfaces
Physical Dimensions

USB 2.0
No larger than 60 x 60 x 150 cm (Length
x Width x Height)
NW 48 Kg
GW 120 Kg

Weight (crated system)

Remote Battery Life
(normal operating conditions)
Environmental Operating Conditions

Ambient temperature
Relative humidity
Atmospheric pressure
Transport and Storage Conditions

Ambient temperature
Relative humidity
Atmospheric pressure

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18 hours
The system operates under the following
atmospheric conditions (nocondensation).
+15 to +30 ºC
20% to 80% , non-condensing
810 to 1050 mbar
The instrument withstands the following
transport and storage conditions without
damage or performance deterioration.
-15 to +60 ºC
10% to 80% non-condensing
750 to 1060 mbar