Avedro, Inc.
KXL System
Operator’s Manual

Copyright 2020. All Rights Reserved.
Printed in U.S.A.

KXL System Operator’s Manual
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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 ortrademarks of Avedro, Inc. All software and documentation is subject toAvedro, Inc. copyrights. All rights reserved 2020.
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

2797

KXL System Operator’s Manual
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Table of Contents
Foreword..............................................................................................................................................................1
1.1
Intended Use of Manual ........................................................................................................... 1
1.2
Intended Use / Indications for Use...................................................................................... 1
1.3
Design Change Disclaimer ...................................................................................................... 1
1.4
Reproduction Disclaimer ......................................................................................................... 1
1.5
User Operation Assistance Statement .............................................................................2
1.6
Contraindications, Warnings and Cautions ....................................................................2
1.6.1 Contraindications ..........................................................................................................2
1.6.2 Warnings ..........................................................................................................................2
1.6.3 Electrical Safety Warnings .......................................................................................2
1.7
Radiation Safety Warnings ....................................................................................................5
1.8
Patient Safety..............................................................................................................................5
1.9
Additional Safety Considerations .......................................................................................5
1.10
FCC Compliance Notice ........................................................................................................ 62

Introduction ................................................................................................................................................7
2.1
System Overview....................................................................................................................... 7
2.1.1 Major Components ....................................................................................................... 83

System Operation ................................................................................................................................... 11
3.1
Touchpad/Keyboard Use ...................................................................................................... 11
3.2
UV Energy (Dose) ................................................................................................................... 13
3.3
Preparing the System ............................................................................................................ 14
3.4
Important Steps before Turning On the System........................................................ 14
3.5Powering Up the System...................................................................................................... 14
3.6
Existing Patient Data.............................................................................................................. 15
3.7
Add New Patient ..................................................................................................................... 16
3.8
Create New Treatment Plan................................................................................................ 17
3.8.1 Select Eye to Treat .................................................................................................... 17
3.8.2 Selecting a KXL Default Treatment Type........................................................ 18
3.8.3 Custom Treatment Plans........................................................................................ 18
3.8.4 Modifying Custom Treatment Parameters ..................................................... 19
3.9
Starting a Treatment............................................................................................................. 20
3.9.1 Insert Treatment / RFID Activation Card ........................................................ 20
3.9.2 Single-use Activation Cards.................................................................................. 21
3.9.3 Multi-use Activation Cards ................................................................................... 22
3.9.4 RFID Card-controlled Limits................................................................................ 23
3.9.5 Sync Alignment Remote ....................................................................................... 24
3.10
Preparing the Patient ............................................................................................................ 26
3.10.1 Applying Riboflavin, Induction, and Alignment........................................... 27
3.11
Initiating Treatment ............................................................................................................... 29
3.12
Monitoring Treatment........................................................................................................... 29
3.13
Pausing a Treatment .............................................................................................................30
3.14
Cancelling Mid-Treatment ................................................................................................... 31
3.15
Capturing Images ................................................................................................................... 32
3.16
Treatment Complete ............................................................................................................. 33
3.17
Reviewing Images .................................................................................................................. 33

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3.18
3.19

3.20
3.21

Deleting Photos....................................................................................................................... 33
Patient Treatment Report ................................................................................................... 35
3.19.1 Adding Notes to a Patient Treatment Report ............................................. 36
3.19.2 Exporting Treatment Report.............................................................................. 37
3.19.3 Viewing a Treatment Report.............................................................................. 39
Powering Down the KXL System..................................................................................... 43
Accessing the Options Menu.............................................................................................44
3.21.1 Manage Clinic Preset Plans ..................................................................................44
3.21.2 System Settings Menu .......................................................................................... 45
3.21.3 System Settings – Altering the System Volume ........................................ 46
3.21.4 System Settings – Altering Camera White Balance ................................. 46
3.21.5 System Settings – Altering Alignment Crosshairs’ Intensity ................. 47
3.21.6 System Settings – Selecting a Different System Language .................. 47
3.21.7 System Settings – Export Service Log ........................................................... 48
3.21.8 System Settings – Backing up and Restoring Patient Data .................. 48
3.21.9 System Settings – Clinic Preset Display Priority ........................................ 49
3.21.10 Service Settings ..................................................................................................... 49
3.21.11 Demo Mode ............................................................................................................... 49

4

Maintenance / Service ......................................................................................................................... 51
4.1
Installation Policy ..................................................................................................................... 51
4.2
Customer Maintenance ......................................................................................................... 51
4.3
Warranty Information ............................................................................................................ 51
4.4
Service Contract Information ............................................................................................. 51
4.5
Per Patient Disposables ........................................................................................................ 51
4.6
Trouble Shooting .................................................................................................................... 52
4.6.1 Wireless Remote ....................................................................................................... 52
4.7
Directions for Disinfection .................................................................................................. 55
4.8
Cleaning the System ............................................................................................................. 55
4.9
Cleaning the Aperture .......................................................................................................... 56
4.10
Articulating Arm Adjustment ............................................................................................ 56
4.11
Moving the System ................................................................................................................ 58
4.12
Storing the System ................................................................................................................ 59
4.13
Software ..................................................................................................................................... 59
4.14
Risks Associated with Disposing of Waste Products .............................................. 59
4.15
Performing a Visible Check ................................................................................................ 59

5

Equipment Classification .................................................................................................................. 60

6

Symbol Library ....................................................................................................................................... 67

7

Specifications..........................................................................................................................................69

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Table of Figures
Figure 2-1. Overview Illustration of System.............................................................................................. 8
Figure 2-2. System Illustrations with Callouts ......................................................................................... 9
Figure 2-3. Wireless Remote .......................................................................................................................... 9
Figure 2-4. KXL Label ..................................................................................................................................... 10
Figure 2-5. UV emitting Label...................................................................................................................... 10
Figure 2-6. Laser Classification Label ....................................................................................................... 10
Figure 3-1. Power Switch................................................................................................................................ 14
Figure 3-2. Patient Database......................................................................................................................... 15
Figure 3-3. Enter Patient Information....................................................................................................... 16
Figure 3-4. Create New Treatment Plan .................................................................................................. 17
Figure 3-5. Select Eye ...................................................................................................................................... 17
Figure 3-6. Perform a Default Treatment Plan ......................................................................................18
Figure 3-7. Save Clinic Preset Treatment Plan ..................................................................................... 19
Figure 3-8. Custom Treatment Plan – Continuous UV Mode ........................................................ 20
Figure 3-9. Insert KXL Activation Card..................................................................................................... 21
Figure 3-10. Reading Activation Card ....................................................................................................... 21
Figure 3-11. Card Treatment Balance ........................................................................................................ 22
Figure 3-12. Card Balance: Treatments Remaining ............................................................................. 22
Figure 3-13. No Treatments Left .................................................................................................................23
Figure 3-14. Invalid Treatment Parameters ............................................................................................23
Figure 3-15. Invalid Treatment Parameters ........................................................................................... 24
Figure 3-16. Sync Remote............................................................................................................................. 24
Figure 3-17. System Setup Status...............................................................................................................25
Figure 3-18. Sync Process Timed Out.......................................................................................................25
Figure 3-19. Remote Indicator Light Status and Meaning ............................................................... 26
Figure 3-20. Remote Indicator Light Status and Meaning ............................................................. 26
Figure 3-21. Prepare For Treatment: Apply riboflavin ....................................................................... 27
Figure 3-22. Align Crosshairs During Induction ................................................................................... 27
Figure 3-23. Alignment of Red Crosshairs – X & Y Axes and Z Axis .......................................... 28
Figure 3-24. Remote Functions ................................................................................................................. 28
Figure 3-25. Start UV Treatment ............................................................................................................... 29
Figure 3-26. Treatment in Progress Screen .......................................................................................... 30
Figure 3-27. Treatment Paused Screen .................................................................................................. 30
Figure 3-28. Confirm Cancel Partial Treatment..................................................................................... 31
Figure 3-29. Treatment Cancelled Confirmation .................................................................................. 31
Figure 3-30. Partial Treatment Not Completed ...................................................................................32
Figure 3-31. Capturing Images .....................................................................................................................32
Figure 3-32. Treatment Complete Screen ............................................................................................. 33
Figure 3-33. Select Trash to delete .......................................................................................................... 34
Figure 3-34. Select Yes to Delete ............................................................................................................. 34
Figure 3-35. Select Done .............................................................................................................................. 35
Figure 3-36. Sample Treatment Report.................................................................................................. 36
Figure 3-37. Comments Icon ....................................................................................................................... 36
Figure 3-38. Comments Section .................................................................................................................37
Figure 3-39. Exporting Treatment Report..............................................................................................37
Figure 3-40. Insert USB ................................................................................................................................. 38
Figure 3-41. USB Error and No Space Left on USB ........................................................................... 38
Figure 3-42. Generating treatment report ............................................................................................ 38
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Figure 3-43. Treatment report exported ............................................................................................... 39
Figure 3-44. Page 1 of 3: Treatment Details.......................................................................................... 40
Figure 3-45. Page 2 of 3: Comments ........................................................................................................ 41
Figure 3-46. Page 3 of 3: Photos............................................................................................................... 42
Figure 3-47. Select “Power Off”................................................................................................................. 43
Figure 3-48. Confirm “Power Off”............................................................................................................. 43
Figure 3-49. Power Off Position ................................................................................................................ 44
Figure 3-50. Press the “Options” button ................................................................................................ 44
Figure 3-51. Manage Clinic Preset Plans ................................................................................................. 45
Figure 3-52. System Settings Menu ......................................................................................................... 45
Figure 3-53. Edit Volume .............................................................................................................................. 46
Figure 3-54. Edit Camera White Balance............................................................................................... 46
Figure 3-55. Alignment Crosshairs Intensity......................................................................................... 47
Figure 3-56. Edit System Language......................................................................................................... 47
Figure 3-57. Export Service Log to USB ................................................................................................ 48
Figure 3-58. Export Service Log in Progress ....................................................................................... 48
Figure 3-59. Clinic Preset Display Priority ............................................................................................. 49
Figure 3-60. Patient List Indicates Demo Mode ................................................................................. 50
Figure 3-61. Demo Mode is Indicated at Top of Screen ................................................................... 50
Figure 4-1. Access Battery Compartment ..............................................................................................52
Figure 4-2. Alignment Remote Lost Sync – Original Remote ....................................................... 53
Figure 4-3. Alignment Remote Lost Sync – Updated Remote ..................................................... 54
Figure 4-4. Position the Arm Parallel to the Floor ............................................................................. 56
Figure 4-5. Loosen Counterbalance Set Screw A .............................................................................. 56
Figure 4-6. Loosen Counterbalance Set Screw B ...............................................................................57
Figure 4-7. Set Arm Tension with Strength Adjustment Screw C ...............................................57
Figure 4-8. Moving System Configuration ............................................................................................ 58

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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 arecontained in this manual. It is the operator’s responsibility to ensure thatall safety instructions in this manual are applied strictly.

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

1.3 Design Change Disclaimer
•

•

•

•

Due to design changes and product improvements, information inthis manual is subject to change without notice. Avedro, Inc.
(hereafter called “Avedro”) reserves the right to change productdesign at any time without notice, which may subsequently affectthe contents of this manual.
Avedro assumes no responsibility for any errors that may appear
in this manual. Avedro will make every reasonable effort to ensurethat 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 thesystem, 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.

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1.5 User Operation Assistance Statement
Should you experience any difficulty in running your KXL System, pleasecontact your local Avedro authorized representative.

1.6 Contraindications, Warnings and Cautions
1.6.1

Contraindications

This section describes situations in which the device should not be usedbecause 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 womenChildren

1.6.2

Warnings

Physicians should evaluate the potential benefits in patients with thefollowing 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 theuser 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 thismanual.

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Portable and mobile RF communications equipment can affectmedical electrical equipment such as the Avedro KXL System.
For Equipment Classifications please refer to Chapter 5.0
Equipment Classifications.

WARNING: Any repair or service must be carried out by Avedro
trained personnel only.
WARNING: Do NOT modify this equipment without authorizationof the manufacturer.
WARNING: To avoid the risk of shock this equipment must only
be connected to a supply mains with protective earth.
To separate system connection to mains, grasp the power cordplug and pull it from outlet to disconnect.
The system is designed for continuous operation using theexternal connector.
WARNING: This equipment is operated with hazardous voltages
that can shock, burn, or cause death. To reduce the possibility ofelectrical 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 authorized 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 toremove 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.

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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 offlammable mixtures or anesthetics.
WARNING: Never look directly into the UV light beam. Neverdirect the beam towards a person except for therapeutic
purposes.
WARNING: Ignoring local regulations on use of electro-optical
medical devices may cause malfunction due to electromagnetic
interference.
WARNING: The remote contains replaceable batteries; if system
is not going to be used for an extended period of time remove
the batteries.
WARNING: Use of not included accessories results in noncompliance 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: Use of this equipment adjacent to or stacked withother equipment should be avoided because it could result in
improper operation. If such use is necessary, this equipment andthe other equipment should be observed to verify that they areoperating normally.
WARNING: Portable RF communications equipment (including
peripherals such as antenna cables and external antennas)
should be used no closer than 30cm (12 inches) to any part of
the Avedro KXL system (110-01019), including cables specified by
the manufacturer. Otherwise, degradation of the performance of
this equipment could result.

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WARNING: System shall not be serviced or maintained while inuse with a Patient.
WARNING: MR Unsafe – Keep away from magnetic resonanceimaging equipment.
WARNING: Do not use a damaged or malfunctioning device. Useof such devices may harm the user and/or patient

1.7 Radiation Safety Warnings
WARNING: Use only laser grade instruments in order to preventreflected UV radiation from smooth metallic surfaces.
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.

1.8

Patient Safety•

The treatment should take place in a quiet and relaxed atmospherein 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 orpatient’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 bedamaged when impacted by the UV beam, possibly resulting in
product degradation. Therefore, only Avedro recommended
accessories or stainless-steel surgical instruments should be used.

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Smooth metallic surfaces can reflect despite the effort to blankthem. 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 aClass B digital device, pursuant to Part 15 of the FCC Rules. These limits
are designed to provide reasonable protection against harmfulinterference in a residential environment. This equipment generates, uses,
and can radiate radio frequency energy and, if not installed and used inaccordance with the instruction manual, may cause harmful interference
to radio communications. However, there is no guarantee thatinterference 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 thefollowing measures:•

Reorient or relocate the receiving antenna.

•

Increase the separation between the equipment and receiver.

•Connect the equipment into an electrical outlet on a circuit different
from that to which the receiver is connected.

•

Consult Avedro Customer Service for help.

•

Properly shielded and grounded cables and connectors must be
used in order to meet FCC emission limits. Proper cables andconnectors are available from Avedro. Avedro is not responsible forany radio or television interference caused by unauthorized changes
or modifications to this equipment. Unauthorized changes ormodifications could void the user's authority to operate theequipment.

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2 Introduction
2.1 System Overview
The KXL System is an electronic medical device which delivers ultraviolet light(365 nm wavelength) in a circular pattern onto the cornea after a solution of
Riboflavin has been applied. Irradiating the Riboflavin creates singlet oxygen,
which forms intermolecular bonds in corneal collagen, stiffening the cornea
through cross-linking. UV flux and irradiation time (that is, fluence) at thecornea 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/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 anapproximate diameter of 9 mm. Alignment lasers are used to aid the user infocusing the beam on the patient’s cornea. Fine alignment of the UV beamthrough observation of the alignment lasers is controlled through a wirelessremote and an internal drive system. Treatment power is selectable by theuser 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 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, UVPower 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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User
Interface/Console/RFID reader

Figure 2-2. System Illustrations with Callouts

ORIGINAL REMOTE CONTROLorUPDATED REMOTE CONTROL

Figure 2-3. Wireless Remote

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Figure 2-4. KXL Label

Figure 2-5. UV emitting Label

Figure 2-6. Laser Classification Label

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3 System Operation
3.1 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 KXL
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 thepatient

Options button(Initial screen)

Displays system settingsand managing presetplans

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 forpatient

UP arrow(various ClinicalProtocol screens)

Increases the value ofthe current field.

DOWN arrow(various ClinicalProtocol screens)

Decreases the value ofthe current field.

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Touchpad Key

Icon

Description/Function

X button(various screens)

Cancels all the entries
on a screen and returns
to the previous screen.

Checkmarkbutton(various screens)

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

Cancel button(various screens)

Cancels all the entries
on a screen and returns
to the previous screen.

Done button(various screens)

Registers any changes
on a screen or provides
user with notifications
and then returns toprevious 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.

CancelTreatment
button(various ClinicalProtocol screens)

Cancels a treatment
session for a patient.

Start timer
buttonStarts treatment timer

Changetreatment typebuttonChanges treatment type

Perform
treatment button(various ClinicalProtocol screens)Starts treatment

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) andthe 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 planmode. See Section 3.8.3•

There are two UV treatment modes available, Continuous and Pulsed.
o 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/cm2 increments. Theenergy range is controlled by the RFID card.
o Pulsed Mode: UV output turns ON and OFF at user selectedintervals.

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/cm2 increments. Theenergy range is controlled by the RFID card.
•

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

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3.3 Preparing the System•

Position the KXL System adjacent to the treatment table or chair. Lockthe 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.

•

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 the power cord plug. This switch provides AC mains power
to the KXL System.

•

Press and release the power-on button on the side of the KXL display
screen. See Figure 3-1. The KXL System will begin a power-up sequence,loading the operating system and all configuration and reference files.

Figure 3-1. Power Switch

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NOTE: If there is a Start-up error, please note any error messages
and contact your distributor or Customer Service.

•

Please see Section 3.21 for Power Down sequence instructions.

•

The Patient List, shown in Figure 3.2, stores:o Previously treated patientso Untreated patients with saved treatment planso New patients with no assigned treatment plans

Figure 3-2. Patient Database

3.6 Existing Patient Data•

To search Patient List for an existing patient, tap in the “searchpatients” box and a keyboard will generate. Type patients name in andresults will populate.

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3.7 Add New Patient•

To begin adding a new patient, select “Add new patient,” and the popup window shown in Figure 3-3 will appear.

Figure 3-3. Enter Patient Information•••

If “Use anonymous patient” is selected, last name field will populate asanonymous and 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” is pressed.

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3.8 Create New Treatment Plan••

Select patient to treat from Patient Database
Press “Create new treatment plan to begin”

Figure 3-4. Create New Treatment Plan

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 as shown in
Figure 3-5.

Figure 3-5. Select Eye

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3.8.2 Selecting a KXL Default Treatment Type•••The System is pre-programmed with 3 KXL Default treatment plans
as shown in Figure 3-5:o Accelerated Epi-Off CXLo Conventional CXLo LASIK Xtra
Treatment parameters are preset for the KXL Default treatment
plans.
Select the desired KXL Default treatment plan and then select“Perform Treatment” to proceed as shown in Figure 3.6.

Figure 3-6. Perform a Default Treatment Plan

3.8.3 Custom Treatment Plans••

Any of the KXL Default plans can be edited to change energy dose,
irradiance or other treatment parameters then saved for future use asa “Custom” treatment plan.
Select the KXL Default as a starting point or select the “Custom”
treatment type tab to create a new, custom plan.
o If KXL Default was selected, press “Save as clinic preset” to saveto the “Custom” treatment type tab.
o Input a name for the clinic preset treatment plan.

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Figure 3-7. Save Clinic Preset Treatment Plan

•
•
•
•

Select “OK” then select the new clinic preset treatment plan from the“Custom” treatment type tab
Individual parameters may be edited in Custom treatment plans.
Press within the specific parameter and use the arrows to increase or
decrease the desired field.
Select “Save changes” if it is desired to use the same custom
treatment plan in the future.

3.8.4 Modifying Custom Treatment Parameters•

There are two UV treatment modes available, Continuous or 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 selectedintervals.

•

In the example below, the user selects “Continuous” UV treatmentmode by pressing the dropdown menu to the right of “UV Delivery”
as shown in Figure 3-8.

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Figure 3-8. Custom Treatment Plan – Continuous UV Mode•

Enter the other desired Custom treatment parameters:o Total UV dose*o UV irradiance (3 – 45 mW/cm2)

NOTE: Total treatment time is automatically calculated and displayed.
* The user may select UV dose in 0.1 J/cm2 increments. The dose
range is controlled by the RFID card.
•

Review and confirm all treatment parameters by selecting “Perform
treatment”.

3.9 Starting a Treatment••

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

3.9.1
•

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

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Figure 3-9. Insert KXL Activation Card

3.9.2 Single-use Activation Cards•

Keep card in place until read is complete.

Figure 3-10. Reading Activation Card•

The user will be alerted that only 1 treatment remains on the card asshown in Figure 3-11.

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Figure 3-11. Card Treatment Balance•

The “OK” button will illuminate when the card has been read andtreatment credit has been accepted by the System. The user may
remove the card at this time if desired.

3.9.3 Multi-use Activation Cards••

Once a multi-use activation card has been inserted, the display willshow the number of treatments remaining on the card.
Activation card can either be removed or remain in the RFID slot andstored for next use.

Figure 3-12. Card Balance: Treatments Remaining

o If treatment card only has one treatment left, the system will inform
user to “Upgradecard before next treatment” as shown in Figure 3-11.
o If no treatments remain on the card, the system alerts the user to insert
a different card as shown in Figure 3-15.

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Figure 3-13. No Treatments Left

3.9.4 RFID Card-controlled Limitso If the user has programmed a UV dose range that is outside theallowable value(s) controlled by the RFID card, an ”Invalid treatment
parameters” message will appear after “Perform treatment” has been
selected.

Figure 3-14. Invalid Treatment Parameters

o Go Back to Treatment Parameters to enter appropriate parameters.
o 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 as shown in Figure 3-16.
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Figure 3-15. Invalid Treatment Parameters

3.9.5 Sync Alignment Remoteo The Sync alignment remote message will be visible on the screen for 15
seconds as shown in Figure 3-16.

Figure 3-16. Sync Remoteo If using the Updated Remote (see Figure 2.3), press any directional
button to synchronize the remote within the 15-second timeframe. Thisis required for every procedure if use of the remote is desired.
o If using the Original Remote (see Figure 2.3), press the sync button
denoted with an “S” on the remote to synchronize the remote within the
15-second timeframe. See Figure 3-17 for sync button location. This isrequired for every procedure if use of the remote is desired.

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Figure 3-17. System Setup Statuso The system will beep every 2 seconds during the 15 second sync
timeframe.
o If the sync button is not pressed within the 15 second timeframe, amessage stating “Sync Alignment Remote” will appear onscreen as
shown in Figure 3-18.
o Press “OK” to attempt to re-sync the remote, or choose to Cancel
Treatment.

Figure 3-18. Sync Process Timed Out

o The various statuses of the Original Remote Indicator Light are shownin Figure 3-19.
• A constantly illuminated remote Indicator Light means that the
remote is synchronized with the KXL.
• If the Indicator Light is blinking constantly, replace batteries in the
remote immediately to ensure proper operation.

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Figure 3-19. Remote Indicator Light Status and Meaningo The various statuses of the Updated Remote Thumbpad Indicator Light
and Battery Indicator Light are shown in Figure 3-20.
Thumbpad Indicator Light Status
No illumination
Revolving blue light
Steady blue light
Steady orange light
Battery Indicator Light Status
No illumination
Steady blue light
Steady orange lightFlashing orange light

Meaning
Off
Synchronizing
Synchronized and Ready
Lost synchronization
Meaning
Off
Battery is OK
Battery needs replacing
Battery must be replaced

Figure 3-20. Remote Indicator Light Status and Meaning

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 thisoccurs, contact your distributor or Customer Service immediately.

3.10 Preparing the Patient•••

Ensure that the patient is lying flat or reclined on a patient table orchair. His or her head should rest on 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 clinicaltechnique. NOTE: Onscreen eye images do not depict the lid speculum.

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3.10.1 Applying Riboflavin, Induction, and Alignmento Apply Riboflavin to the treatment eye in accordance with the Riboflavin
Instructions for Use (IFU) and press “Start Timer.”

Figure 3-21. Prepare For Treatment: Apply riboflavin

CAUTION: Riboflavin is not a part of the KXL System described inthis manual. For details, please refer to the Riboflavin’s Instructions
for Use.
o

Red alignment lasers will turn on 30 seconds before the end of theInduction period as shown in Figure 3-22.

Figure 3-22. Align Crosshairs During Inductiono

KXL has two alignment lasers as shown in Figure 3-23.
•

Red crosshair for X and Y axis positioning.

•

A second red crosshair for Z axis positioning.

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o NOTE: Crosshairs may differ in appearance. They may appear thicker,
thinner, longer or shorter.

Figure 3-23. Alignment of Red Crosshairs – X & Y Axes and Z Axiso

When alignment lasers turn on, align the crosshairs over the eye to betreated.
•Manually move the KXL head back and forth and left and right
until the X/Y axes’ red crosshairs are aligned to the center of thepupil.

•

Manually move the KXL 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 orby pressing the onscreen arrows.

o NOTE: For correct alignment when using the remote, the Avedro logo
on KXL head should face the user. Figure 3-24 displays the remotefunctions to use during the alignment process.

ORIGINAL REMOTEorUPDATED REMOTE

Figure 3-24. Remote Functions
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3.11 Initiating Treatment•

Once the Riboflavin application, Induction, and Alignment of Crosshairs
are complete, initiate treatment by pressing the “Start UV treatment”
button as shown in Figure 3-25.

Figure 3-25. Start UV Treatment•

The patient should fixate on the red X & Y alignment crosshairthroughout the treatment.

•

Patients should remain still during the treatment.

WARNING: Start treatments only after the photosensitizer is applied.
CAUTION: UV light is emitted when the Avedro logo on the opticalhead 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.

3.12 Monitoring Treatment•

Check continuously that the area of interest on the cornea is illuminatedwith the UVA light and adjust as necessary using the wireless remote or
the onscreen arrows.

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Figure 3-26. Treatment in Progress Screeno NOTE: When using Pulsed Treatment mode, UVA light will not be visible
during the OFF periods. The User Interface will not change to “UV isOFF” during these cycles.

3.13 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 UV treatment”
button.

Figure 3-27. Treatment Paused Screen

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To cancel or resume treatment select “Cancel treatment” or “Resume
UV treatment” respectively. See Section 3.14 if cancelling a session.

3.14 Cancelling Mid-Treatment••

A warning pop-up will appear when “Cancel treatment” is selected midtreatment as shown in Figure 3-28.
To confirm treatment cancellation, select “Yes”.

Figure 3-28. Confirm Cancel Partial Treatment•

If treatment cancellation was confirmed, an onscreen “Treatment
Cancelled” message will appear as shown in Figure 3-29.

Figure 3-29. Treatment Cancelled Confirmation••

Select “OK” on the Cancel Treatment confirmation screen.
Partial Treatment information will be displayed as shown in Figure 3-30.

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Figure 3-30. Partial Treatment Not Completed

3.15 Capturing Images•••

Images can be taken at any stage throughout the treatment process.
To capture an image, select the camera button in the top right handcorner of the eye image as shown in Figure 3-31.
The image is automatically saved and available for review posttreatment.

Figure 3-31. Capturing Images

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3.16 Treatment Complete•

At the completion of a treatment, a summary of treatment parameters
will be displayed, and the screen will show “Treatment complete” asshown in Figure 3-32.

Figure 3-32. Treatment Complete Screen•••

Carefully remove the device from the patient area.
Follow up with normal post-op care.
Remove speculum.

3.17 Reviewing Images•

All images taken throughout treatment are available for review post
treatment.
o Select “View Photos” to enter the photo gallery as shown in Figure 3-32.

3.18 Deleting Photos••

Photos taken throughout treatment can be deleted.
In the Photo Gallery, select the trash icon next to the photo to bedeleted as shown in Figure 3-33.

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Figure 3-33. Select Trash to delete•

Once a photo is selected for deletion, select “Yes” to delete the photo,or select “No” to keep the image.

Figure 3-34. Select Yes to Delete•

Once deletion is confirmed, photo will not be retrievable.

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

Figure 3-35. Select Done

3.19 Patient Treatment Report
•

•
•
•

A treatment report is generated containing patient information,
treatment details, photos taken throughout treatment, and notes. A
sample report is shown in Figure 3-36.
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.

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Figure 3-36. Sample Treatment Report

3.19.1 Adding Notes to a Patient Treatment Reporto From the Patient Database screen, select the patient’s name.
o Press the message icon as shown in Figure 3-37 to enter comments
about the patient’s treatment.
o Keyboard will become available to make comments to the patient’s
report. Figure 3-38 depicts comments in a Patient Report.

Figure 3-37. Comments Icon

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Figure 3-38. Comments Section

3.19.2

Exporting Treatment Reporto Select “Export treatment report” as shown in Figure 3-39 to save reportto a USB stick.
o Report will be exported as PDF.

Figure 3-39. Exporting Treatment Reporto The screen will prompt to insert USB drive as shown in Figure 3-40.
NOTE: Avedro does not supply USB drive for storing patient data.

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Figure 3-40. Insert USB

o If the USB is full or the system is unable to read the USB, an error
message will be displayed as shown in Figure 3-41.

Figure 3-41. USB Error and No Space Left on USB

o If there is no issue with the USB, a message will appear stating“Generating treatment report.”

Figure 3-42. Generating treatment reporto When the treatment report is exported, a confirmation message willappear as shown in Figure 3-43.

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Figure 3-43. Treatment report exported

3.19.3

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

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Figure 3-44. Page 1 of 3: Treatment Details

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Figure 3-45. Page 2 of 3: Comments

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Figure 3-46. Page 3 of 3: Photos

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3.20 Powering Down the KXL System•

Select “Power Off” on the Patient List homescreen as shown in Figure
3-47.

Figure 3-47. Select “Power Off”•

Confirm powering off system by selecting “Yes” as shown in Figure 3-48.

Figure 3-48. Confirm “Power Off”•

Wait for the software to shut down and the screen to go blank.

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Turn the master power switch on the KXL base to the “Off” position asshown in Figure 3-49.

Figure 3-49. Power Off Position

3.21 Accessing the Options Menu

o From the Patient List homescreen, press the “Options” button to display
the 4 Options menus, as shown in Figures 3-50.

Figure 3-50. Press the “Options” button

3.21.1 Manage Clinic Preset Planso Select “Manage clinic preset plans” to alter any Custom preset
treatment plans.
o Upto 4 clinic preset plans may be saved.

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Figure 3-51. Manage Clinic Preset Plans

3.21.2 System Settings Menuo Select “System settings” from the Options menu to access the Systemsettings shown in Figure 3-52.

Figure 3-52. System Settings Menu

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3.21.3

System Settings – Altering the System Volume

o Select “Audio Volume” from the System Settings menu to alter thesound volume level.

Figure 3-53. Edit Volume

3.21.4

System Settings – Altering Camera White Balanceo Select “Camera white balance” from the System Settings menu tochange the light conditions within the console.
o Select desired white balance and click “Save” to return to the System
Settings menu.
o NOTE: Typical office lighting is under 5000K. As a result, the Systemdefault setting is Tungsten 2800K. If a different light source is used, it
may be useful to edit the white balance condition.

Figure 3-54. Edit Camera White Balance
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3.21.5

System Settings – Altering Alignment Crosshairs’ Intensity

o Select “Alignment Crosshairs Intensity” from the System Settings menu
to alter the brightness of the alignment crosshairs. The screen shown in
Figure 3-55 will appear.
o Adjust crosshair brightness and select “Save.”

Figure 3-55. Alignment Crosshairs Intensity

3.21.6 System Settings – Selecting a Different System Languageo Select “System Language” to change the language of the Graphical
User Interface.
o Select the desired language from the menu as shown in Figure 3-56.

Figure 3-56. Edit System Language

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3.21.7

System Settings – Export Service Log

o Select “Export service log” from the System Settings menu.
o Follow onscreen instructions to insert a USB drive to the USB port asshown in Figure 3-57.

Figure 3-57. Export Service Log to USB

o The System automatically begins transferring the service log and shows
a progress bar of the transfer process as shown in Figure 3-58.

Figure 3-58. Export Service Log in Progresso Once the export is complete, press the “OK” button to return to the
System Settings menu.

3.21.8 System Settings – Backing up and Restoring Patient Datao Patient Data may be backed up onto a USB and saved for a later time
off the System by selecting “Back up Patient Data” from the Options
menu.
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o Patient Data that was previously saved onto a USB can be restored to
the System by selecting “Restore patient data” from the Options menu.

3.21.9 System Settings – Clinic Preset Display Priority
o The Treatment Plan screen displays the KXL Defaults initiallyo To display the Custom tab as the primary treatment plan tab instead of
KXL Defaults tab, select “Custom” from the “Clinic preset display
priority” menu.

Figure 3-59. Clinic Preset Display Priority

3.21.10Service Settingso Service Settings are only available to Avedro and Service personnel
with a KXL Advanced Settings access card.
o If selected, the user will be prompted to scan an access card.

3.21.11

Demo Mode

NOTE: Not for use in treating patientso Demo mode allows users to train on use of the KXL System without
requiring treatment cards and without using UV light.
- Select “Demo Mode”- Select “Start” to use the System in Demo Modeo The KXL System screens will indicate that the System is currently in“Demo Mode” as shown in Figure 3-60 and Figure 3-61.
o To exit “Demo Mode,” select “Exit Demo Mode” from the Patient List
screen.

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Figure 3-60. Patient List Indicates Demo Mode

Figure 3-61. Demo Mode is Indicated at Top of Screen

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4 Maintenance / Service
By definition, “maintenance” refers to those non-technical procedures aneveryday operator must perform to keep the system working properly.
The word “service,” by contrast, 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-upof the system. Following initial installation and once the system isoperating 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 specificinstructions relating to installation or set-up of the system. Per
your service agreement, any further hardware adjustment, otherthan what is specified for normal operation, should be performedby, 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 bya qualified service representative while under service contract. If
you have trouble with your system, refer to the Troubleshooting
section below or call your local Avedro Representative.

4.3 Warranty Information•

A Warranty is supplied separately with the purchasing information.

4.4 Service Contract Information•

A service contract is available on all KXL Systems. The contract
provides for regularly scheduled service and field upgrades. It also
provides for any non-scheduled service calls that may benecessary.

4.5 Per Patient Disposables•

Per Patient Disposables can be ordered from Avedro or your
Avedro-authorized distributor. Use only Avedro products or
Avedro-approved products with your KXL System. Avedro shall

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not be liable for damage to or malfunction of the system, which itdeems, was caused by the use of unauthorized materials.

4.6 Trouble Shooting•

The KXL System checks its status at start-up automatically. If thestatus is incorrect, the software prevents the operator frominitiating treatments.

4.6.1
•

Wireless Remote

The KXL System uses a remote control with replaceable batteries.
To change the batteries in the remote control, slide the front of
the remote with buttons backward while pressing the back of theremote in the opposite direction. See Figure 4.1.

Figure 4-1. Access Battery Compartment••

If the batteries run low, the System will lose its connection with theremote and notify the user of the need to try again. If the remote
fails to sync, select “Continue Without Remote” or “Cancel
Treatment.”
Figure 4.1 depicts onscreen guidance for KXL Systems using theOriginal Remote; Figure 4.2 depicts onscreen guidance for KXL
Systems using the Updated Remote.

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Figure 4-2. Alignment Remote Lost Sync – Original Remote

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Figure 4-3. Alignment Remote Lost Sync – Updated Remote

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Original Remoteo If light on the remote is flashing two times per second, theremote’s batteries need to be changed.
o If the light on the remote is flashing once per second, then it is
not synchronized.
o If the remote does not re-synchronize by pressing the “Sync”
button, replace the batteries.

•

Updated Remoteo If battery status light is orange, the remote’s batteries need to
be changed shortly.
o If the battery status light is flashing orange, the remote’s
batteries need to be changed immediately – There is notenough power to complete a treatment with the remote.

•If replacing the batteries does not allow the System tosynchronize, contact your local Avedro Service Representative.

4.7 Directions for Disinfection••

No components of the KXL System are designed to be sterilized
by the operator.
ONLY external cleaning and disinfection is recommended.
o For disinfection purposes, use only 70% isopropyl alcohol
preparations or 10% bleach solutions. Use soft fiber-freewipes.

4.8 Cleaning the System••••

Use a soft damp cloth to clean the KXL System.
The exterior of the System can be cleaned using a lint-free cloth
dampened with dilute 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 thesystem.
CAUTION: Power down the system and remove the power supply
cord from 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.

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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 andparticles from the glass surface of the aperture.

4.10 Articulating Arm Adjustment
If the articulating arm does not hold the Optical Head in a fixed vertical
position, follow the steps outlined below to counterbalance thearticulating arm.
•

Cycle the arm up and down through its full range of motion and set
the arm horizontal, i.e. approximately parallel to the floor.

Figure 4-4. Position the Arm Parallel to the Floor•

If the arm drifts downward, lift the arm to the top of its range andloosen Counterbalance Set Screw A by turning the screw at least a½ turn. Use a 3/32 Allen Wrench. See Figure 4-5.

Figure 4-5. Loosen Counterbalance Set Screw A

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Reposition the arm horizontally. Loosen the upper Counterbalance
Set Screw B by turning the screw at least a ½ turn. Use a 3/32 Allen
Wrench. See Figure 4-6.

Figure 4-6. Loosen Counterbalance Set Screw B•

Maintain the horizontal arm position by supporting load as needed.

•

Set the arm tension with the Strength Adjustment Screw C. Use a
7/32 Allen Wrench and turn the Screw C counter clockwise until thearm just begins to move slowly upward. There should be a slightbounce-back when the arm is lightly tapped down after adjustment.
See Figure 4-7.
NOTE: 15-20 turns may be needed. If the arm continues todroop and the screw cannot be turned further, contact yourlocal Avedro service representative.

Figure 4-7. Set Arm Tension with Strength Adjustment Screw C•

Turn Strength Adjustment Screw C two full revolutions in theclockwise direction.

•

Ensure that the arm is stationary to barely creeping upward.

•

Raise the arm to the highest position and tighten Counterbalance
Set Screw A until contact is made, then tighten ½ to ¾ max
revolutions. See Figure 4-5.

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Position the arm horizontally and tighten Counterbalance Set Screw
B until contact is made, then tighten ½ to ¾ revolutions. See Figure
4-6.

•

Cycle the arm up and down through its full range of motion. Ensure
there is no upward or downward drift.

•

NOTE: If the arm drifts upward from any position, return tohorizontal and turn Strength Adjustment Screw C clockwise ¼revolution at a time until it no longer rises on its own.

4.11 Moving the System••

The KXL is designed as a movable system within an officeenvironment. If it ever proves necessary to transport or ship the
KXL System, for any reason, contact your local Avedro
representative. Packing and transporting the system should be
performed only by Avedro trained and authorized personnel.
Prior to moving the KXL System from one room to another, themonitor should be moved sideways, and the KXL Head should bepositioned 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 theback

UI monitor to theside
UV optical headnear handle

Figure 4-8. Moving System Configuration

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4.12 Storing the System
•
•
•

•

Follow all the storage temperature and humidity range
specifications as listed in Chapter 7.0 - Specifications.
Close all panels on the system to prevent dust and moisture fromentering; this is mandatory.
Turn OFF all the components and switch off the master powerswitch as well. Disconnect the power cord from its electrical outlet
Remove the batteries from the wireless 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.

4.14 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 to each treatment.

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5 Equipment Classification
According to EN60601-1 Medical Device Electrical Standard•••

Protection against electrical shocko Class 1 (external electrical power source)
Degree of protection against electric shocko Not classified, equipment not provided with applied parto System ingress protection: IP20 (No protection against
ingress of water)o Updated remote ingress protection: IP53
Method of sterilization or disinfectiono Disinfect-able device• Degree of protection for use in the presence of a
flammable as aesthetic mixture
o No protection• Use conditionso Continuous service

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

According to EN60825-1 Safety of laser productions•

Alignment lasers are Class 1 Laser ProductAccording to EN62471 Photobiological safety of lamps and lamp
systems•••

IEC 62471:2006 Risk Group 2
EN 62471:2008 Risk Group 3
UVA LED is Risk Group 3

According to Annex II.3 of Directive 93/42/EEC•

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EMC Requirements
The KXL System 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 RFcommunications equipment may affect the KXL System.

Guidance and manufacturer’s declaration - electromagnetic emissions
The KXL System is intended for use in the electromagnetic environment specified
below. The customer or the user of the KXL System should assure that it is used insuch an environment.
Emissions test
RF emissions

ComplianceGroup 1The KXL System uses RF energy only for its
internal function. Therefore, its RF emissions
are very low and are not likely to cause any
interference in nearby electronic equipment.

Class BThe KXL System is suitable for use in all
establishments including domestic
establishments and those directly connectedto the public low-voltage power supply
network that supplies buildings used fordomestic purposes.

CISPR 11
RF emissions
CISPR 11
Harmonic
emissionsClass AIEC 61000-3-2
VoltageComplies
fluctuations/ flicker
emissions
IEC 61000-3-3

ML-00040 Rev E

Electromagnetic environment — guidance

KXL System Operator’s Manual | Page 62

Guidance and manufacturer’s declaration — electromagnetic immunity
The KXL System is intended for use in the electromagnetic environment
specified below. The customer or the user of the KXL System should assurethat it is used in such an environment.
Immunity test

IEC 60601
test level

Compliance
level

Electrostatic±8 kV contact±8 kV contact

discharge (ESD)±15 kV air±15 kV air±2 kV for power
supply lines±1 kV for
input/output lines±2 kV for power
supply lines

IEC 61000-4-2

Electrical fasttransient/burst
IEC 61000-4-4

Not ApplicableSurge
IEC 61000-4-5±1 kV line(s) toline(s)

Input /Output Lines±1 kV line(s) toline(s)±2 kV line(s) toearth±2 kV line(s) toearth

Voltage dips,
shortinterruptions andvoltagevariations on
power supply
input lines
IEC 61000-4-11

0 % UT

0 % UT(100 % dip in UT)
for 0.5 cycle
0% UT(100 % dip in UT)
for 0.5 cycle
0% UT(100% dip in UT)
for 1 cycles
70% UT(100% dip in UT)
for 1 cycles
70% UT(30% dip in UT) for
25/30 cycles
0% UT(30% dip in UT) for
25/30 cycles
0% UT(100 % dip in UT)
for 5 sec(100 % dip in UT)
for 5 sec

Power frequency(50/60 Hz)
magnetic field
IEC 61000-4-8

30 A/m30 A/mElectromagnetic
environment guidance
Floors should be wood,concrete or ceramic tile. If
floors are covered withsynthetic material, therelative humidity should be
at least 30%.
Mains power quality shouldbe that of a typicalcommercial or hospitalenvironment.
Mains power quality shouldbe that of a typicalcommercial or hospitalenvironment.
Mains power quality shouldbe that of a typicalcommercial or hospitalenvironment, If the user ofthe KXL System requires
continued operation during
power mains interruptions, it
is recommended that the
KXL System be poweredfrom an uninterruptible
power supply or a battery.
Power frequency magnetic
fields should be at levels
characteristic of a typicallocation in a typicalcommercial or hospitalenvironment.

NOTE: UT is the a.c. mains voltage prior to application of the test level.

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Guidance and manufacturer’s declaration — electromagnetic immunity
The KXL System is intended for use in the electromagnetic environment specified
below. The customer or the user of the KXL System should assure that it is used insuch an environment.
IEC 60601
ComplianceElectromagnetic environment —Immunity test
test level
level
guidance
Portable and mobile RF communications
equipment should be used no closer to any
part of the KXL System, including cables,
than the recommended separation distancecalculated from the equation applicable tothe frequency of the transmitter.
Recommended separation distance
Conducted RF
IEC61000-4-6

3 Vrms150 kHz to 80
MHz

3 Vrms𝑑𝑑 = 1,2√𝑃𝑃 80 MHz to 800 MHz 𝑑𝑑 = 1,2√𝑃𝑃

Radiated RF
IEC 61000-4-3

3 V/m
80 MHz to 2.7
GHz

3V/m

𝑑𝑑 = 1,2√𝑃𝑃 𝑑𝑑 = 2,3√𝑃𝑃 80 MHz to 2.7 GHz
where P is the maximum output power
rating of the transmitter in watts (W)according to the transmitter manufacturer
and d is the recommended separation
distance in metres (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site
survey,a should be less than the compliancelevel in each frequency range.b

Proximity fields 15 specificfrom RF wireless frequencies.
communications
Immunity level
equipment (IEC
9-28V/m
61000-4-3:2006
A1:2007 A2:2010)15 specificfrequencies.

Interference may occur in the vicinity ofequipment marked with the following
symbol:Immunity level
9-28V/mNOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected byabsorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoreticallywith accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic
site survey should be considered. If the measured field strength in the location in which the KXL System is used
exceeds the applicable RF compliance level above, the KXL System should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or
relocating the KXL System.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

ML-00040 Rev E

KXL System Operator’s Manual | Page 64

Recommended separation distances between portable and mobile RFcommunications equipment and the KXL System
The KXL System is intended for use in an electromagnetic environment in whichradiated RF disturbances are controlled. The customer or the user of the KXL
System can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters)
and the KXL System as recommended below, according to the maximum output
power of the communications equipment.

Rated
maximum
output powerof transmitter(W)

Separation distance according to frequency oftransmitter m
150 kHz to 80MHz

80 MHz to 800
MHz

800 MHz to 2.5
GHz

0.01

𝑑𝑑 = 1.2√𝑃𝑃

0.12

𝑑𝑑 = 1.2√𝑃𝑃

𝒅𝒅 = 𝟐𝟐. 𝟑𝟑√𝑷𝑷

0.1

0.38

0.38

0.73

1

1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

0.12

0.23

For transmitters rated at a maximum output power not listed above, therecommended separation distance d in metres (m) can be estimated using theequation applicable to the frequency of the transmitter, where P is the maximum
output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency
range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects andpeople.

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The KXL System contains an RFID function which transmits and receives at the 13.56
MHz frequency. This functionality may be interfered with by other equipment, even ifthat other equipment complies with CISPR emission requirements.

The KXL System contains the following RF transmitters:

RFID Reader••••

13.56MHz Reader/Writer
Integral Antenna: Maximum 4” Read Range
Max output power is 200mW
Meets: ISO18000-3, ISO15693

ML-00040 Rev E

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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 incircleProtected earth (ground)

5. Ingress Protection
SymbolIP20 (original remote)
IP53 (updated remote)

6. Power button

Ingress Protection(solids under 12.5 mm
and no protection
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)
13. Umbrella withraindrops

ML-00040 Rev E

NW
GW

WeightKeep Dry: Store protectedfrom moisture (symbol iswith or without rain drops)

KXL System Operator’s Manual | Page 68

Text Symbol
14. Broken glass

Symbol Illustration
orDefinition
Contents are fragile, handle
with care

15. Two up arrows

Keep arrows on carton
pointing up

16. Water drop in a box

Humidity limits(percentages below
symbol are the acceptable
range for humidity)

17. Operating
Temperature limits

Operating Temperature
limits

18. Storage Temperature
limitsStorage Temperature limits

19. MR crossed in a circle

MR Unsafe – Keep awayfrom magnetic resonanceimaging (MRI) equipment

20. Storage Pressure
limitsStorage Atmosphericpressure limits

21. Operating Pressure
limitsOperating Atmosphericpressure limits

22. Signal emitted

RF transmitted throughdeviceML-00040 Rev E

AVEDRO | 69 of 69

7 Specifications
Specification
Electrical

Description
Line voltages 100 – 240 volts AC
Current 2A – 1A
Single Phase
RMS, 50/60 Hz
Original Remote 2x AAA batteries
Updated Remote 2x AA 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

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

Physical Dimensions
Weight (crated system)
Remote Battery Life
(normal operating conditions)Remote and Dongle FCC ID
and Operating Frequencies
Environmental Operating
Conditions
Ambient temperature
Relative humidity
Atmospheric pressure
Transport and Storage
Conditions
Ambient temperature
Relative humidity
Atmospheric pressure

ML-00040 Rev E

FCC ID: SXJ87027-TX (original remote)
FCC ID: 2AVGK-KXLTX (updated remote)2.405-2.475 GHz.
The system operates under the following
atmospheric conditions (no condensation).
+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