Avedro, Inc.
KXL System
Operator’s Manual

Copyright 2018. All Rights Reserved.
Printed in U.S.A.

KXL Operator’s Manual Rev C
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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 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

KXL Operator’s Manual Rev C
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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............................................................................................6
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) ......................................................................................................................... 14
3.3
Preparing the System .................................................................................................................. 15
3.4
Important Steps before Turning On the System ........................................................... 15
3.5Powering Up the System ........................................................................................................... 15
3.6
Existing Patient Data ................................................................................................................... 16
3.7
Add New Patient ........................................................................................................................... 17
3.8
Create New Treatment Plan..................................................................................................... 18
3.8.1
Select Eye to Treat ..................................................................................................... 18
3.8.2
Select Treatment Type ............................................................................................. 19
3.8.3
Adjusting Treatment Parameters ....................................................................... 20
3.9
Select Treatment Mode .............................................................................................................. 21
3.9.1
Continuous UV Mode ................................................................................................. 21
3.9.2
Pulsed UV Mode .......................................................................................................... 22
3.10
Starting a Treatment................................................................................................................... 23
3.10.1
Insert Treatment / RFID Activation Card ....................................................... 23
3.10.2 Single-use Activation Cards .................................................................................. 23
3.10.3 Multi-use Activation Cards ..................................................................................... 24
3.10.4 RFID Card-controlled Limits ................................................................................. 25
3.10.5 Sync Alignment Remote ......................................................................................... 27
3.11
Preparing the Patient ................................................................................................................. 29
3.11.1 Applying Riboflavin, Induction, and Alignment .............................................. 29
3.12
Initiating Treatment ..................................................................................................................... 32
3.13
Monitoring Treatment ................................................................................................................ 33
3.14
Pausing a Treatment ................................................................................................................... 33
3.15
Cancelling Mid-Treatment........................................................................................................ 34
3.16
Capturing Images ......................................................................................................................... 36

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3.17
3.18
3.19
3.20

3.21
3.22

Treatment Complete .................................................................................................................. 37
Reviewing Images ........................................................................................................................ 37
Deleting Photos ............................................................................................................................. 38
Patient Treatment Report ........................................................................................................ 39
3.20.1 Adding Notes to a Patient Treatment Report ............................................ 40
3.20.2 Exporting Treatment Report ................................................................................. 41
3.20.3 Viewing a Treatment Report ................................................................................ 44
Powering Down the KXL System ......................................................................................... 47
Accessing the System Settings Menu................................................................................ 48
3.22.1 Service Settings ........................................................................................................... 49
3.22.2 Selecting a Different System Language ......................................................... 49
3.22.3 Altering the Intensity of Alignment Crosshairs ........................................... 50
3.22.4 Altering the System Volume ................................................................................. 50
3.22.5 Export Service Log ..................................................................................................... 51
3.22.6 Altering Audible Beep Intervals .......................................................................... 52
3.22.7 Altering Camera White Balance .......................................................................... 53

4

Maintenance / Service ........................................................................................................ 54
4.1
Installation Policy .......................................................................................................................... 54
4.2
Customer Maintenance.............................................................................................................. 54
4.3
Warranty Information ................................................................................................................. 54
4.4
Service Contract Information ................................................................................................. 54
4.5
Per Patient Disposables ............................................................................................................ 54
4.6
Trouble Shooting .......................................................................................................................... 55
4.6.1
Wireless Remote ......................................................................................................... 55
4.7
Directions for Disinfection ....................................................................................................... 56
4.8
Cleaning the System ................................................................................................................... 56
4.9
Cleaning the Aperture................................................................................................................ 57
4.10
Articulating Arm Adjustment ................................................................................................. 57
4.11
Moving the System ...................................................................................................................... 57
4.12
Storing the System ...................................................................................................................... 58
4.13
Software ............................................................................................................................................ 58
4.14
Risks Associated with Disposing of Waste Products ................................................ 58
4.15
Performing a Visible Check ..................................................................................................... 58

5

Equipment Classification .................................................................................................... 59

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 ....................................................................................................................................... 16
Figure 3-2. Patient Database............................................................................................................................... 16
Figure 3-3. Enter Patient Information ............................................................................................................. 17
Figure 3-4. Create New Treatment Plan ....................................................................................................... 18
Figure 3-5. Select Eye ............................................................................................................................................. 18
Figure 3-6. Select Treatment Type .................................................................................................................. 19
Figure 3-7. Adjusting Parameters ....................................................................................................................20
Figure 3-8. Adjusted Treatment Plan ............................................................................................................20
Figure 3-9. Select Continuous Treatment Mode ....................................................................................... 21
Figure 3-10. Modifying Continuous Treatment Parameters ............................................................... 22
Figure 3-11. Insert Activation Card ................................................................................................................... 23
Figure 3-12. Reading Tag ...................................................................................................................................... 23
Figure 3-13. Card Balance: Treatments Remaining ................................................................................. 24
Figure 3-14. Card Balance: 1 Treatment Remaining ................................................................................ 24
Figure 3-15. No Treatments Left ....................................................................................................................... 25
Figure 3-16. Invalid Treatment Parameters ................................................................................................. 25
Figure 3-17. Invalid Treatment Parameters ................................................................................................. 26
Figure 3-18. Sync Remote .................................................................................................................................... 27
Figure 3-19. System Setup Status .................................................................................................................... 27
Figure 3-20. Sync Process Timed Out .......................................................................................................... 28
Figure 3-21. Remote Indicator Light Status and Meaning ................................................................... 28
Figure 3-22. Prepare Treatment: Apply Riboflavin ................................................................................. 29
Figure 3-23. Align Crosshairs During Induction....................................................................................... 30
Figure 3-24. Alignment of Red Crosshairs – X & Y Axes and Z Axis ............................................ 30
Figure 3-25. Remote Functions ......................................................................................................................... 31
Figure 3-26. Start UV Treatment ..................................................................................................................... 32
Figure 3-27. Treatment in Progress Screen ................................................................................................ 33
Figure 3-28. Treatment Paused Screen ........................................................................................................34
Figure 3-29. Confirm Cancel Partial Treatment ........................................................................................34
Figure 3-30. Treatment Cancelled Confirmation ..................................................................................... 35
Figure 3-31. Partial Treatment Not Completed ......................................................................................... 35
Figure 3-32. Capturing Images.......................................................................................................................... 36
Figure 3-33. Treatment Complete Screen................................................................................................... 37
Figure 3-34. Select Trash to delete ................................................................................................................ 38
Figure 3-35. Select Yes to Delete .................................................................................................................... 38
Figure 3-36. Select Done...................................................................................................................................... 39
Figure 3-37. Sample Treatment Report ....................................................................................................... 40
Figure 3-38. Comments Icon ............................................................................................................................. 40
Figure 3-39. Comments Section........................................................................................................................ 41
Figure 3-40. Exporting Treatment Report ................................................................................................... 41
Figure 3-41. Insert USB .......................................................................................................................................... 42
Figure 3-42. USB Error and No Space Left on USB ............................................................................... 42
Figure 3-43. Generating treatment report ..................................................................................................43
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Figure 3-44. Treatment report exported .....................................................................................................43
Figure 3-45. Page 1 of 3: Treatment Details .............................................................................................. 44
Figure 3-46. Page 2 of 3: Comments .............................................................................................................45
Figure 3-47. Page 3 of 3: Photos..................................................................................................................... 46
Figure 3-48. Select “Power Off” ....................................................................................................................... 47
Figure 3-49. Confirm “Power Off” ................................................................................................................... 47
Figure 3-50. Power Off Position .......................................................................................................................48
Figure 3-51. Press the “Options” button .......................................................................................................48
Figure 3-52. System Settings Menu ............................................................................................................... 49
Figure 3-53. Edit System Language .............................................................................................................. 49
Figure 3-54. Alignment Crosshairs Intensity ............................................................................................. 50
Figure 3-55. Edit Volume .................................................................................................................................... 50
Figure 3-56. Export Service Log to USB ....................................................................................................... 51
Figure 3-57. Export Service Log in Progress .............................................................................................. 51
Figure 3-58. Select Beep Intervals .................................................................................................................. 52
Figure 3-59. Edit Camera White Balance .................................................................................................... 53
Figure 4-1. Alignment Remote Lost Sync .................................................................................................... 55
Figure 4-2. Moving System Configuration .................................................................................................. 57

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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 withoutauthorization of 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
cord plug 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 thepossibility of electrical shock, and inadvertent UVA exposure
do not remove any fixed panels. Ensure that all service to thesystem, 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.

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WARNING: Position the power cord so that it cannot be
tripped over, walked on, rolled over, crimped, bent, pinched,or accidentally pulled from the wall outlet.
WARNING: Do not use the instrument near water and be
careful not to spill liquids on any part of it.
WARNING: Do not operate the KXL System in the presenceof flammable 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 toelectromagnetic interference.
WARNING: The remote contains replaceable batteries; ifsystem is not going to be used for an extended period oftime remove the batteries.
WARNING: Use of not included accessories results in noncompliance of the device
WARNING: System may be interfered with by otherequipment 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
and the other equipment should be observed to verify thatthey are operating normally.

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WARNING: Portable RF communications equipment(including peripherals such as antenna cables and externalantennas) should be used no closer than 30cm (12 inches) toany part of the Avedro KXL system (110-01019), including
cables specified by the manufacturer. Otherwise, degradationof the performance of this equipment could result.
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 such devices may harm the user and/or patient

1.7 Radiation Safety Warnings
WARNING: Use only laser grade instruments in order toprevent reflected 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 or patient’s
chair or the system not be moved during the treatment procedure.
CAUTION: The KXL System is a medical device. It may be
operated, therefore, only in health care facilities or medical
areas under the supervision of medically trained personnel.

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1.9 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.

•

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 that interference
will not occur in a particular installation. If this equipment does cause
harmful interference to radio or television reception, which can be
determined by turning the equipment off and on, the user is encouraged
to try to correct the interference by one or more of the following
measures:•

Reorient or relocate the receiving antenna.

•

Increase the separation between the equipment and receiver.

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

•

Consult Avedro Customer Service for help.

•

Properly shielded and grounded cables and connectors must be
used in order to meet FCC emission limits. Proper cables 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 asolution of Riboflavin has been applied. Irradiating the Riboflavin creates
singlet oxygen, which forms intermolecular bonds in corneal collagen,stiffening the cornea through cross-linking. UV flux and irradiation time(that is, fluence) at the cornea are controlled by an onboard computer
system.
The Optics Head houses the UVA irradiation mechanism and camera.
The LED is preset by the manufacturer to emit UVA radiation at awavelength 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 theuser in focusing the beam on the patient’s cornea. Fine alignment of the
UV beam through observation of the alignment lasers is controlled
through a wireless remote and an internal drive system. Treatment
power is selectable by the user from 3 mW/cm2 to 45 mW/cm2 in 1
mW/cm2 increments. Total Energy is selectable in 0.1 J/cm2 incrementson the user interface. However, actual limits to power and energy arecontrolled 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 UVEnergy, UV Power and UV Pulse Cycle Times) are selected through theuser 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 (disposablesupplied 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

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 andicons unique to KXL System operation. Chapter 2 identifies anddescribes 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 Device
Settings screens)

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

Checkmarkbutton(various ClinicalProtocol screensand Device
Settings screen)

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

Cancel button(various ClinicalProtocol screensand Device
Settings screen)

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

Export button

Exports patient
treatment report to USB

Add comment
button (patient
overview screen)

Add notes to a patient
treatment report

Trash Can icon

Delete photos taken
during treatment

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
Clinical Protocol
screens)

Starts treatment

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Touchpad Key

Icon

Description/Function

Return toTreatment
button(Confirm Cancel
Session screen)

Cancels the Cancel
Session command andreturns to theTreatment screen.

Return button(various Device
Settings screen)

Returns to the Device
Settings menu.

Restore to
factory presets(manage clinicpreset plans)Presets restored tonormal 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 andTotal 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 andPulsed.
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.
Lock the casters to secure the device’s position.

•

Make sure the system is turned ON.

•

When system is in use, keep head away from bright lights, such as
positioning in front of windows.

•

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 isfunctioning properly before starting a treatment.

•

To ensure the system is functioning properly, consider thefollowing mandatory points:
o Inspect the device, accessories, and connecting cables forvisible 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 powerup sequence, loading the operating system and all configuration
and reference files.

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Figure 3-1. Power Switch•

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

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3.7 Add New Patient•

To begin adding a new patient, select “Add new patient,” and the
pop-up 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 as anonymous 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 databaseonce “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”
Treatment plans can be made and saved prior to patient’s
arrivalFigure 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 shownin Figure 3-5.

Figure 3-5. Select Eye

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3.8.2 Select Treatment Type
•

•
•

•
•

The system is pre-programmed with five preset treatment plans
as shown in Figure 3-6:
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 or other treatment parameters then saved for futureuse.
Select “Custom” treatment plan to create a new, custom plan.
Once a pre-set treatment plan is chosen or a customizable
treatment plan is saved, select “Next” to proceed.

Figure 3-6. Select Treatment Type

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3.8.3 Adjusting Treatment Parameters•

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

Figure 3-7. Adjusting Parameters••

When finished editing parameters, select “Save for later
treatment” for future use, 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, as
shown in Figure 3-8.

Figure 3-8. Adjusted Treatment Plan
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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 selectedintervals.

3.9.1

Continuous UV Mode

To select Continuous treatment mode, select “Continuous” from thedrop down menu to the right of “UV Delivery” as shown in Figure 3-9.

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 anddisplayed.
* The user may select UV Energy in 0.1 J/cm2 increments. Theenergy range is controlled by the RFID card.

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Review and confirm all treatment parameters by selecting “Savefor later treatment” or “Save and perform treatment”; if thetreatment parameters are not correct, select wrongful parameters
and then re-enter the desired treatment parameters and save.

Figure 3-10. Modifying Continuous Treatment Parameters3.9.2 Pulsed UV Modeo To select Pulsed treatment mode, select “Pulsed” from the drop
down menu to the right of “UV Delivery”.

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3.10 Starting a Treatment••

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

3.10.1 Insert Treatment / RFID Activation CardoInsert the activation card all the way into the RFID slot andleave in place.

Figure 3-11. Insert Activation Card

3.10.2 Single-use Activation Cardso

Keep card in place until read is complete.

Figure 3-12. Reading TagoML-00040

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

KXL Operator’s Manual Rev C | Page 24

3.10.3 Multi-use Activation Cards
Once a multi-use activation card has been inserted, the display
will show the number of treatments remaining on the card.
o Activation card can either be removed or remain in the RFID
slot and stored for next use.
oFigure 3-13. Card Balance: Treatments Remaining
o If treatment card only has one treatment left, the system will
inform user to “Replace card before next treatment” as shownin Figure 3-14.

Figure 3-14. Card Balance: 1 Treatment Remaining

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o If no treatments remain on the card, the system alerts the user
to insert a different card or to save the treatment for later, as
shown in Figure 3-15.

Figure 3-15. No Treatments Left

3.10.4

RFID Card-controlled Limitso If the user has programmed a UV Energy range that is outside
the allowable value(s) controlled by the RFID card, thefollowing message will appear after “Perform treatment” hasbeen selected.

Figure 3-16. Invalid Treatment Parameters

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o Go Back to Treatment Parameters to enter an appropriate
parameter.
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 3-17.

Figure 3-17. Invalid Treatment Parameters

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3.10.5 Sync Alignment Remoteo The Sync alignment remote message will be visible on thescreen for 15 seconds as shown in Figure 3-18.

Figure 3-18. Sync Remoteo Press the sync button denoted with an “S” on the remote tosynchronize the remote within the 15 second timeframe. See
Figure 3-19 for sync button location. This is required for every
procedure if use of the remote is desired.

Figure 3-19. System Setup Statuso The system will beep for the last 3 seconds of the 15 second
sync timeframe.

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o If the sync button is not pressed within the 15 second
timeframe, a message stating “Alignment Remote Lost Sync”
will appear onscreen as shown in Figure 3-20.
o Press “OK” to attempt to re-sync the remote, or choose to“Continue Without Remote.”

Figure 3-20. Sync Process Timed Out
o The various statuses of the remote Indicator Light are shown in
Figure 3-21.
• A constantly illuminated remote Indicator Light means thatthe remote is synchronized with the KXL.
• If the Indicator Light is blinking constantly, replace batteries
in the remote immediately to ensure proper operation.

Figure 3-21. Remote Indicator Light Status and Meaning
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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 thetreatment 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 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.

3.11.1

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 3-22. Prepare Treatment: Apply Riboflavin
CAUTION: Riboflavin (vitamin B2) is not a part of the KXL
System described in this manual. For details , please refer tothe Riboflavin’s Instructions for Use.
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oRed alignment lasers will turn on 30 seconds before the end of
the Induction period as shown in Figure 3-23.

Figure 3-23. Align Crosshairs During Inductiono

KXL has two alignment lasers as shown in Figure 3-24.
•

Red crosshair for X and Y axis positioning.

•

A second red crosshair for Z axis positioning.
NOTE: Crosshairs may differ in appearance. They may
appear thicker, thinner, longer or shorter.

Figure 3-24. Alignment of Red Crosshairs – X & Y Axes and Z Axis

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oWhen alignment lasers turn on, align the crosshairs over the eye
to be treated.
•

Manually move the KXL head back and forth and left andright until the X/Y axes’ red crosshairs are aligned to thecenter of the pupil.

•

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 remoteor by pressing the onscreen arrows.
NOTE: For correct alignment when using the remote, theAvedro logo on KXL head should face the user. Figure 3-25
displays the remote functions to use during the alignment
process.

Figure 3-25. Remote Functions

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3.12 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 3-26.

Figure 3-26. 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 isapplied.
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’stable or chair are secured and not moved after alignmentand during treatment.

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3.13 Monitoring Treatment•

Check continuously that the area of interest on the cornea isilluminated with the UVA light and adjust as necessary using thewireless remote or the onscreen arrows.

Figure 3-27. 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.

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 suchcase, the UV light can be switched OFF by pushing the “Pause UV
treatment” button.

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Figure 3-28. Treatment Paused Screen•

To cancel or resume treatment select “Cancel treatment” or“Resume UV treatment” respectively. See Section 3.15 if cancellinga session.

3.15 Cancelling Mid-Treatment••

A warning pop-up will appear when “Cancel treatment” is selected
mid-treatment as shown in Figure 3-29.
To confirm treatment cancellation, select “Yes”.

Figure 3-29. Confirm Cancel Partial Treatment
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If treatment cancellation was confirmed, an onscreen “Treatment
Cancelled” message will appear as shown in Figure 3-30.

Figure 3-30. Treatment Cancelled Confirmation••

Select “OK” on the Cancel Treatment confirmation screen.
Partial Treatment information will be displayed as shown in Figure
3-31.

Figure 3-31. Partial Treatment Not Completed

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3.16 Capturing Images•••

Images can be taken at any stage throughout the treatment
process.
To capture an image, select the camera button in the top righthand corner of the eye image as shown in Figure 3-32.
The image is automatically saved and available for review posttreatment.

Figure 3-32. Capturing Images

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3.17 Treatment Complete•

At the completion of a treatment, a summary of treatment
parameters will be displayed, and the screen will show “Treatmentcomplete” as shown in Figure 3-33.

Figure 3-33. Treatment Complete 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 the photo gallery as shown in Figure
3-33.

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3.19 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 3-34.

Figure 3-34. Select Trash to delete•

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

Figure 3-35. Select Yes to Delete

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Once deletion is confirmed, photo will not be retrievable.
Select “Done” to confirm which photos will be displayed in
the treatment report.

Figure 3-36. Select Done

3.20 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 3-37.
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 3-37. Sample Treatment Report

3.20.1 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 3-38 to enter
comments about the patient’s treatment.

Figure 3-38. Comments Icon
o Keyboard will become available to make comments to thepatient’s report.
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Figure 3-39. Comments Section

3.20.2 Exporting Treatment Reporto Select “Export treatment report” as shown in Figure 3-40 tosave report to a USB stick.
o Report will be exported as PDF.

Figure 3-40. Exporting Treatment Report

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o The screen will prompt to insert USB drive as shown in Figure
3-41.
NOTE: Avedro does not supply USB drive for storing patient
data

Figure 3-41. Insert USB
o If the USB is full or the system is unable to read the USB, anerror message will be displayed as shown in Figure 3-42.

Figure 3-42. USB Error and No Space Left on USB

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

Figure 3-43. Generating treatment reporto When the treatment report is exported, a confirmation message
will appear as shown in Figure 3-44.

Figure 3-44. Treatment report exported

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

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 KXL System•

Select “Power Off” on the Patient List homescreen as shown in
Figure 3-48.

Figure 3-48. Select “Power Off”•

Confirm powering off system by selecting “Yes” as shown in
Figure 3-49.

Figure 3-49. Confirm “Power Off”

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Wait for the software to shut down and the screen to go blank.
Turn the master power switch on the KXL base to the “Off”
position as shown in Figure 3-50.

Figure 3-50. Power Off Position

3.22 Accessing the System Settings Menu
o From the Patient List homescreen, press the “Options” button,then press “System Settings” as shown in Figures 3-51 and 3-52.

Figure 3-51. Press the “Options” button

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Figure 3-52. System Settings Menu

3.22.1Service 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.

3.22.2 Selecting a Different System Languageo Select “System Language” to change the language of theGraphical User Interface.
o Select the desired language from the menu as shown in Figure 3-53.

Figure 3-53. Edit System Language
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3.22.3 Altering the Intensity of Alignment Crosshairso Select “Alignment Crosshairs Intensity” from the System
Settings menu to alter the brightness of the alignment
crosshairs. The screen shown in Figure 3-54 will appear.
o Adjust crosshair brightness and select “Save.”

Figure 3-54. Alignment Crosshairs Intensity

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

Figure 3-55. Edit Volume

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3.22.5 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 as shown in Figure 3-56.

Figure 3-56. 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 3-57.

Figure 3-57. Export Service Log in Progresso Once the export is complete, press the “OK” button to return to
the System Settings menu.
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3.22.6 Altering Audible Beep Intervals
o Select “Beep interval” from the System Settings menu to alter
the time between audible beeps while induction is in progress.
o Click the minute and second icons to increase or decrease time,then press save to return to the System Settings menu.

Figure 3-58. Select Beep Intervals

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

Figure 3-59. Edit Camera White Balance

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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 Remoteo The KXL System uses a remote control with replaceable
batteries. If the batteries run low, the system will lose its
connection with the remote and notify the user of the need toeither re-synchronize or “Continue Without Remote.”

Figure 4-1. Alignment Remote Lost Sync
o 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.

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o If the remote does not re-synchronize by pressing the “Sync”
button, replace the batteries.
o 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-free wipes.

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 notunder 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.

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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 KXL Head in a fixedvertical position, contact your local Avedro service representative.

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 4-2. 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 Ingress protection: IP20 (No protection against ingress of water)
Method of sterilization or disinfectiono Disinfect-able device
Degree of protection for use in the presence of a flammable asaesthetic 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•Class IIa

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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

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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 assurethat it is used in such an environment.
Immunitytest

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±2 kV for power
supply lines±1 kV for
input/output lines

Not Applicable

IEC 61000-4-2

Electrical fasttransient/burst
IEC 61000-4-4±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

0 % UT

0 % UT(100 % dip in UT)
for 0.5 cycle(100 % dip in UT)
for 0.5 cycle

0% UT

0% UT

(100% dip in UT)
for 1 cycles(100% dip in UT)
for 1 cycles

IEC 61000-4-11

70% UT

70% UT(30% dip in UT) for
25/30 cycles(30% dip in UT) for
25/30 cycles

0% UT

0% UT

(100 % dip in UT)
for 5 sec(100 % dip in UT)
for 5 secSurge
IEC 61000-4-5

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.
Immunitytest

IEC 60601
test level

Compliance
level

Electromagnetic environment —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

3 Vrms

IEC61000-4-6

150 kHz to 80
MHz

Radiated RF

3 V/m

IEC 61000-4-3

80 MHz to 2.7
GHz

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

3V/m

𝑑𝑑 = 1,2√𝑃𝑃 𝑑𝑑 = 2,3√𝑃𝑃 80 MHz to 2.7 GHz
where P is the maximum output power ratingof the transmitter in watts (W) according to
the transmitter manufacturer and d is therecommended 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 isaffected by absorption 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.

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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 ofthe 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.

ML-00040

KXL Operator’s Manual Rev C | Page 64
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
WiFi Adapter

Frequency Modulation

5 GHz (802.11a/n)

2.4 GHz (802.11b/g/n)

Frequency band

5.15 GHz - 5.85 GHz

2.400 - 2.4835 GHz(dependent on country)(dependent on country)

BPSK, QPSK, 16 QAM, 64

CCK, DQPSK, DBPSK

Modulation

QAM
Wireless Medium

Channels

5 GHz UNII: Orthogonal

2.4 GHz ISM: Orthogonal

Frequency Division

Frequency Division

Multiplexing (OFDM)

Multiplexing (OFDM)

4 to 12 (dependent on

Channel 1-11 (US only)

country)

Channel 1-13 (Japan,
Europe)Max Output Power

ML-00040< 100mW<100mW

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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

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)
13. Umbrella withraindrops

ML-00040

NW
GW

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

KXL Operator’s Manual Rev C | 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

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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

USB 2.0

Physical Dimensions

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

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

Ambient temperature
Relative humidity
Atmospheric pressure

ML-00040

FCC ID: SXJ87027-TX
2.405-2.475 GHz.
The system operates under thefollowing atmospheric conditions (nocondensation).
+15 to +30 ºC
20% to 80% , non-condensing
810 to 1050 mbar
The instrument withstands thefollowing transport and storage
conditions without damage or
performance deterioration.
-15 to +60 ºC
10% to 80% non-condensing
750 to 1060 mbar