Avedro, Inc.
KXL® System
Operator’s Manual

Copyright 2023. Avedro, a Glaukos Company. 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 or trademarks of Avedro,
Inc. All software and documentation are subject to Avedro, Inc. copyrights. Avedro is awholly owned subsidiary of GLAUKOS Corporation. All rights reserved 2023.
Microsoft and Windows are registered trademarks and trademarks, respectively, ofMicrosoft Corporation. Any other trademarks or service marks contained within thismanual are the property of their respective owners.

For more information, contact:
Avedro, a Glaukos Company

Avedro, a Glaukos Company
30 North Ave
Burlington, MA 01803+1-844-528-3376

KXL System Operator’s Manual
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Table of Contents
1

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

1.6.1 Radiation Safety Warnings ............................................................................................ 6

2

1.7

Patient Safety ........................................................................................................................... 6

1.8

Additional Safety Considerations ............................................................................................. 6

1.9

FCC Compliance Notice ............................................................................................................. 6

Introduction ...................................................................................................................................... 8
2.1

System Overview ...................................................................................................................... 8
2.1.1 Major Components ........................................................................................................ 93

System Operation ........................................................................................................................... 12
3.1

Charging the KXL System Battery ........................................................................................... 12

3.2

Touchpad/Keyboard Use ........................................................................................................ 13

3.3

UV Dose .................................................................................................................................. 14
3.3.1

Continuous Mode ....................................................................................................... 14

3.3.2

Pulsed Mode ............................................................................................................. 14

3.4

Preparing the System ............................................................................................................. 14

3.5

Important Steps Before Turning on the System ..................................................................... 15

3.6Powering Up the System ........................................................................................................ 15

3.7

Set Riboflavin Induction Period .............................................................................................. 16

3.8

Select UV Treatment Mode .................................................................................................... 17

3.9

3.8.1

Continuous UV Treatment Mode ............................................................................... 17

3.8.2

Pulsed UV Treatment Mode ...................................................................................... 18

Starting Treatment ................................................................................................................. 20
3.9.1

Single-use Disposables ............................................................................................... 20

3.9.2

Multi-use Disposables ............................................................................................... 21

3.9.3

RFID Card Controlled Limits ...................................................................................... 22

3.9.4

Sync Alignment Remote ............................................................................................ 22

3.10

Preparing the Patient.............................................................................................................. 23

3.11

Alignment of the Device ......................................................................................................... 24

3.12

Initiating Treatment ................................................................................................................ 26

3.13

Monitoring Treatment ............................................................................................................ 26

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3.14

Stopping a Treatment ............................................................................................................. 27

3.15

Treatment Complete .............................................................................................................. 28

3.16

Pausing or Canceling a Treatment .......................................................................................... 29

3.17

Powering Down the System.................................................................................................... 30

3.18

Checking KXL System Battery Function after Storage ............................................................ 31

3.19

Using the Device Settings Menu ............................................................................................. 32
3.19.1 Advanced Settings .................................................................................................... 32

45

3.19.2

Editing System Language ......................................................................................... 32

3.19.3

Editing Alignment Crosshairs Intensity .................................................................... 33

3.19.4

Editing System Volume ............................................................................................ 33

3.19.5

Copying Treatment Data to USB .............................................................................. 33

3.19.6

Editing Default Treatment Parameters.................................................................... 35

Maintenance / Service .................................................................................................................... 36
4.1

Installation Policy.................................................................................................................... 36

4.2

Customer Maintenance .......................................................................................................... 36

4.3

Warranty Information ............................................................................................................ 36

4.4

Service Contract Information ................................................................................................. 36

4.5

Per Patient Disposables .......................................................................................................... 37

4.6

Troubleshooting ..................................................................................................................... 37
4.6.1

Wireless Remote ........................................................................................................ 37

4.6.2

Internal Rechargeable Battery .................................................................................. 38

4.7

Directions for Sterilization or Disinfection.............................................................................. 38

4.8

Cleaning the System ............................................................................................................... 38

4.9

Cleaning the Aperture ............................................................................................................ 38

4.10

Articulating Arm Adjustment .................................................................................................. 39

4.11

Moving the System ................................................................................................................. 42

4.12

Storing the System .................................................................................................................. 42

4.13

Software ................................................................................................................................. 43

4.14

Identifying Risks Associated with Disposing of Waste Products............................................. 43

4.15

Performing a Visible Check ..................................................................................................... 43

Equipment Classification ................................................................................................................. 44
5.1

Equipment Classification ........................................................................................................ 445.2

EMC Guidance ........................................................................................................................ 45

5.3

RF Transmitters .......................................................................... Error! Bookmark not defined.
5.3.1

RFID Reader ................................................................................................................ 49

5.3.2

Wireless Remote Control .......................................................................................... 49

6

Symbol Library ................................................................................................................................ 50

7Specifications .................................................................................................................................. 52

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Table of Figures
Figure 2-1. Overview Illustration of KXL System .............................................................................................. 9
Figure 2-2. System Illustrations with Callouts ............................................................................................... 10
Figure 2-3. Wireless Remote ......................................................................................................................... 10
Figure 2-4. KXL Label...................................................................................................................................... 11
Figure 2-5. UV Emitting Label ........................................................................................................................ 11
Figure 2-6. Alignment Laser Classification Label ........................................................................................... 11
Figure 3-1. Power Switch ............................................................................................................................... 15
Figure 3-2. Startup Screen ............................................................................................................................. 16
Figure 3-3. Induction Period Screen .............................................................................................................. 16
Figure 3-4. Select Continuous Treatment Mode Screen ............................................................................... 17
Figure 3-5. Continuous UV Treatment Parameters Screen ........................................................................... 18
Figure 3-6. Confirm Continuous Treatment Parameters Screen ................................................................... 18
Figure 3-7. Select Continuous Treatment Mode Screen ............................................................................... 18
Figure 3-8. Pulsed UV Treatment Parameters Screen ................................................................................... 19
Figure 3-9. Set Pulsed UV Cycle Times Screen ............................................................................................... 19
Figure 3-10. Confirm Pulsed UV Treatment Parameters Screen ................................................................... 20
Figure 3-11. Reading Activation Card ............................................................................................................ 20
Figure 3-12. Treatments Remaining .............................................................................................................. 21
Figure 3-13. Final Treatment ......................................................................................................................... 21
Figure 3-14. No Treatments Remaining ......................................................................................................... 22
Figure 3-15. Invalid Treatment Parameters................................................................................................... 22
Figure 3-16. Remote Sync Status ................................................................................................................... 23
Figure 3-17. Prepare Patient Screen .............................................................................................................. 24
Figure 3-18. Align Crosshairs During Induction ............................................................................................. 25
Figure 3-19. Remote Functions ..................................................................................................................... 25
Figure 3-20. Red Crosshairs X & Y Axes, Red Crosshairs Z Axis Alignment .................................................... 25
Figure 3-21. Induction Complete ................................................................................................................... 26
Figure 3-22. Treatment Screen ...................................................................................................................... 27
Figure 3-23. Treatment Paused Screen ......................................................................................................... 27
Figure 3-24. Treatment Complete Screen ..................................................................................................... 28
Figure 3-25. Confirm Cancel Session Screen ................................................................................................. 29
Figure 3-26. Confirm Cancel Partial Treatment ............................................................................................. 29
Figure 3-27. Partial Treatment Information .................................................................................................. 30

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Figure 3-28. Power Off .................................................................................................................................. 30
Figure 3-29. Power Off Position..................................................................................................................... 30
Figure 3-30. KXL System Plug......................................................................................................................... 31
Figure 3-31. KXL System Battery Status Indicator ......................................................................................... 31
Figure 3-32. Device Settings Menu ................................................................................................................ 32
Figure 3-33. Edit System Language ................................................................................................................ 32
Figure 3-34. Edit Alignment Crosshairs Intensity........................................................................................... 33
Figure 3-35. Edit Volume ............................................................................................................................... 33
Figure 3-36. Data Transfer to USB ................................................................................................................. 34
Figure 3-37. Edit Default UV Treatment Mode Parameters .......................................................................... 35
Figure 3-38. Edit Default Treatment Parameters (Continuous & Pulsed) ..................................................... 35
Figure 3-39. Edit Default UV Pulse Parameters (Pulsed Only) ....................................................................... 35
Figure 4-1. Alignment Remote Lost Sync ....................................................................................................... 37
Figure 4-2. Position the Arm Parallel to the Floor ......................................................................................... 39
Figure 4-3. Turn the Adjustment Screw ......................................................................................................... 39
Figure 4-4. With Arm Raised, Tighten Set Screw (A) ..................................................................................... 40
Figure 4-5. With Arm Horizontal, Tighten Set Screw (B) ............................................................................... 40
Figure 4-6. Summary of Further Counterbalance Adjustments .................................................................... 41
Figure 4-7. Moving System Configuration ..................................................................................................... 42
Table 5-1. Electromagnetic Emissions ........................................................................................................... 45
Table 5-2. Electromagnetic Immunity ........................................................................................................... 47
Table 5-3. Electromagnetic Immunity (continued) ........................................................................................ 47
Table 5-4. Recommended Separation Distances ........................................................................................... 48
Table 5-5. Highest Emissions ......................................................................................................................... 49

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1 Foreword
Intended Use of ManualThis manual is designed to serve the operators of the Avedro, Inc. KXL® System. All
operating instructions, product illustrations, screen graphics, troubleshooting/error
messages, and other relevant information are contained in this manual. It is theoperator’s responsibility to ensure that all safety instructions in this manual are appliedstrictly.

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

Design Change Disclaimer•

Due to design changes and product improvements, information in thismanual is subject to change without notice. Avedro, Inc. (hereafter called“Avedro”) reserves the right to change product design at any time without
notice, which may subsequently affect the contents of this manual.

•

Avedro assumes no responsibility for any errors that may appear in thismanual. Avedro will make every reasonable effort to ensure that this manualis up to date and corresponds with the shipped KXL System.

•

The touchscreen images depicted in this manual are representative only.
Depending on the software version of the system, minor differences may
appear between the actual touchscreen displays and images shown in thismanual.

•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.

Reproduction Disclaimer
Neither this manual nor any part of it may be reproduced, photocopied, or electronicallytransmitted in any way without the advanced written permission of Avedro, Inc.

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KXL System Operator’s Manual | Page 2User Operation Assistance Statement
Should you experience any difficulty in running your KXL System, please contact your local
Avedro-authorized representative.

Contraindications, Warnings and Cautions
1.1.1 Contraindications
This section describes situations in which the device should not be used because
the risk of use clearly outweighs any possible benefit. Conditions that may
contraindicate the use of the device include:•

Corneal thickness, with epithelium, of less than < 375 microns.

•

Corneal melting disorders•

Aphakic patients•

Pseudophakic patients without UV blocking lens implanted•

Pregnant and nursing women•Children

1.1.2

Warnings

Physicians should evaluate the potential benefits in patients with the following
conditions:•

Herpes simplex, herpes zoster keratitis, recurrent corneal erosion, corneal
dystrophy•

Epithelial healing disorders•

In this manual, Caution is defined as: a statement that alerts the user to thepossibility of a problem with the device associated with its use or misuse.
Such problems include device malfunction, device failure, damage to thedevice or damage to other property. The caution statement includes the
precaution that should be taken to avoid the hazard.

•

In this manual, Warning is defined as: a statement that alerts the user to thepossibility of injury, death, or other serious adverse reactions associated withthe use or misuse of the device.

1.1.3

Electrical Safety Warnings

This equipment requires special precautions regarding electromagnetic
compatibility (EMC). Installation and use should be carried out according to the
EMC information provided in this manual.

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Portable and mobile RF communications equipment can affect medical electricalequipment such as the Avedro KXL System.
For Equipment Classifications, please refer to Chapter 5.0 Equipment
Classifications.

WARNING: WARNING: Any repair or service must be carried out by Avedro
trained personnel only.
WARNING: Do NOT modify this equipment without authorization of the
manufacturer.

WARNING: To avoid the risk of shock this equipment must only beconnected to a supply mains with protective earth.
Even with the power cord removed, there is the potential for an electricalshock from the 12VDC internal power source.
The system is designed for continuous operation using the external
connector or its internal rechargeable battery.

WARNING: This equipment is operated with hazardous voltages that can
shock, burn, or cause death. To reduce the possibility of electrical shock,and inadvertent UVA exposure do not remove any fixed panels. Ensurethat all service to the system, beyond what is described in this manual,including to the rechargeable battery, is performed only by qualified
Avedro service personnel.

WARNING: Power down system and remove the wall plug and turn off thepower switch before servicing or cleaning (disinfecting) the equipment.
Never pull cords to remove the power cord from the outlet. Grasp thepower cord plug and pull it from the outlet to disconnect.

WARNING: Do not operate the equipment with a damaged power cord.
WARNING: Position the power cord so that it cannot be tripped over,walked on, rolled over, crimped, bent, pinched, or accidentally pulled fromthe wall outlet.

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WARNING: Do not use the instrument near water and be careful not tospill liquids on any part of it.

WARNING: The USB port can only be used when the system is not intreatment mode, Do not connect to the USB during treatment.

WARNING: Do not operate the KXL System in the presence of flammablemixtures or anesthetics.

WARNING: Never look directly into the UV light beam. Never direct thebeam towards a person except for therapeutic purposes.

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 notgoing to be used for an extended period of time, remove the batteries.

WARNING: Do not use adjacent to or stack with other equipment; if it isused adjacent to or stacked with other equipment, verify that theequipment behaves normally as intended.

WARNING: Use of not included accessories results in non-compliance ofthe device.

WARNING: System may be interfered with by other equipment even if that
equipment complies with CISPR Emissions requirements. See Table 5-1.

WARNING: Portable RF communications equipment (including peripheralssuch as antenna cables and external antennas) should be used no closer
than 30cm (12 inches) to any part of the Avedro KXL system, including
cables specified by the manufacturer. Otherwise, degradation of theperformance of this equipment could result.

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WARNING: System shall not be serviced or maintained while in use with apatient.

WARNING: No modification of this equipment is allowed.

WARNING: Do not use a damaged or malfunctioning device. Use of suchdevices may harm the user and/or patient.
WARNING: MR Unsafe – Keep away from magnetic resonance imaging
equipment.

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1.1.1 Radiation Safety Warnings
WARNING: UV emitted from this product. Avoid eye and skin exposure to
unshielded products. Never direct the beam towards a person except fortherapeutic purposes.

WARNING: Always wear UVA protective goggles when the KXL system isturned on.

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

Patient Safety
The treatment should take place in a quiet atmosphere in order not to distract theattention of the patient.
•

The patient should lie on a table or patient's chair.

•

The patient’s head should rest comfortably in a headrest. It is imperative thatthe table or patient’s chair and the System not be moved during thetreatment procedure.
CAUTION: The KXL System is a medical device. It may be operated,
therefore, only in health care facilities or medical areas under thesupervision of medically trained personnel.

Additional Safety Considerations•

Any modification of the system's external light beam by means of opticalelements is strictly prohibited.

•

Plastic instrumentation such as speculums or eye shields may be damaged
when impacted by the UV beam, possibly resulting in product degradation.
Smooth metallic surfaces can reflect despite the effort to blank them.
Therefore, only laser grade instruments should be used.

FCC Compliance NoticeThis equipment has been tested and found to comply with the limits for a Class B digital
device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide
reasonable protection against harmful interference in a residential environment.

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This equipment generates, uses, and can radiate radio frequency energy and, if not
installed and used in accordance with the instruction manual, may cause harmfulinterference 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 tocorrect 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 fromthat to which the receiver is connected.

•

Consult Avedro Customer Service for help.

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

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2 Introduction
System Overview
The KXL System is an electronic medical device which delivers ultraviolet light (365 nm
wavelength) in a circular pattern onto the cornea after a solution of Riboflavin has been
applied. Irradiating the Riboflavin creates singlet oxygen, which forms intermolecularbonds in corneal collagen. UV flux and irradiation time (that is, fluence) at the cornea arecontrolled by an onboard computer system.
The Optics Head houses the UVA irradiation mechanism. The LED is preset by the
manufacturer to emit UVA radiation at a wavelength of 365 nm at an intensity of 3
mW/cm2 to 45 mW/cm2.
A fixed aperture mounted in the UVA irradiation beam path is used to produce a circulararea of irradiation at the treatment plane with a diameter of 9 mm. Alignment lasers areused to aid the user in focusing the beam on the patient’s cornea. Fine alignment of the
UV beam through observation of the alignment lasers is controlled by the user through awireless remote. Treatment power is selectable by the user from 3 mW/cm 2 to 45
mW/cm2 in 1 mW/cm2 increments. Total Energy is selectable in 0.1 J increments on theuser interface, but the actual limits 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. An internal battery powers thesystem; the battery is recharged by a system internal charger from any standard AC
outlet. The treatment parameters (Riboflavin Induction Period, Total UV Energy, UVPower, and UV Pulse Cycle Times) are selected through the user interface touchscreen
computer.
The KXL System is used in conjunction with a Riboflavin solution and an RFID activation
card.
NOTE: The depictions of the KXL System and user interface screenshots included in thismanual are for demonstration purposes only. Actual product may vary.

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2.1.1 Major Components
The major components of the KXL System include the following:•

Optics Head with UV source•

KXL console with user interface•

Wireless remote control (with replaceable batteries)•

KXL Accelerated Crosslinking Treatment Kit (disposable supplied separately)

Figure 2-1. Overview Illustration of KXL System

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Figure 2-2. System Illustrations with Callouts

Figure 2-3. Wireless Remote

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Figure 2-4. KXL Label

Figure 2-5. UV Emitting Label

Figure 2-6. Alignment Laser Classification Label

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3 System Operation
Charging the KXL System Battery
NOTE: Prior to initial use, the internal battery pack of the KXL must be charged
overnight.
•

In order to maintain battery charge, it is recommended that the KXL beconnected to a grounded mains supply at all times or at the end of eachbusiness day, including when not in use.

•

The charging status of the battery is identified by the color of the light locatedon the column of the KXL.
-•

Red/Orange: Low, charging
Yellow: Charging
Green: Fully charged

The KXL battery should last for 16 hours during normal operation. The System
software will notify the user when the battery needs to be charged.

NOTE: If the battery does not appear to be charging or retaining its charge, pleasecontact your local Avedro Service Representative.
NOTE: The KXL System prohibits a treatment if there is insufficient battery power toperform a treatment. (See Chapter 4 Maintenance/Service for more information on
troubleshooting battery problems.)

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Touchpad/Keyboard Use
The table below identifies and describes important touchpad keys and icons unique to
KXL System operation. Chapter 2 identifies and describes the System’s major
components.
Touchpad Key

Icon

Description/Function

Power Off button(Initial screen)

Turns OFF electric power to theinternal computer.

Start New Treatment button(Initial screen)

Starts a new clinical treatment
protocol.

UP arrow(various Clinical Protocol
screens)

Increases the value of the current
field.

DOWN arrow(various Clinical Protocol
screens)

Decreases the value of the current
field.

X button(various Device Settings
screens)

Cancels all the entries on aparticular screen and returns to theprevious screen.

Checkmark button(various Clinical Protocol
screens and Device Settings
screen)Directs the system to accept thecurrent screen entries and toproceed to the next step.

Cancel Session button(various Clinical Protocol
screens)

Cancels a treatment session for aparticular patient. A prompt is thendisplayed to confirm your decision.

Return button(various Device Settings
screen)Returns to the Device Settings
menu.

KXL

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CAUTION: Only qualified and experienced personnel shall operate the
System.

KXL System Operator’s Manual | Page 14

UV Dose•The UV Energy (Dose) is the product of the UV Power (Irradiance) and the UV
Irradiation Time. The UV Energy and UV Power are adjustable and thecalculated UV Irradiation Time is displayed.

•

The System tracks UV Energy, UV Power, UV Irradiation Time and Total
Treatment Time during the treatment.

•

There are two UV treatment modes available, Continuous and Pulsed.

3.1.1 Continuous ModeIn Continuous Mode, UV output is constant for the duration of the UV treatment.
•

Continuous Mode Parameters:-

Induction Period:
Wavelength:
UV Energy:-

UV Power:

1 second – 30 minutes
365 nmControlled by the RFID card; User
may select in 0.1 J increments
3 – 45 mW/cm2

3.1.2 Pulsed ModeIn Pulsed Mode, UV output turns ON and OFF at user selected intervals•

Pulsed Mode Parameters:-

Induction Period:
Wavelength:
UV Energy:-

UV Power:
UV ON Time:UV OFF Time:

1 second – 30 minutes
365 nmControlled by the RFID card; User
may select in 0.1 J increments
15 – 45 mW/cm2
1.0 – 4.0 seconds
1.0 – 4.0 seconds

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

Preparing the System•

Position the KXL System adjacent to the treatment table or chair. Lock thecasters to secure the device’s position.

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•

Check glass window of beam aperture for dust and dirt. See Sections 4.8 and
4.9 for cleaning instructions.

Important Steps Before Turning on the System•

The user is responsible for assuring that the KXL System is functioning
properly and is in good working condition before starting a treatment.

•

To ensure the System is functioning properly, consider the following
mandatory points:-

Inspect the device, accessories, and connecting cables for visible
damage.
Take into consideration your local regulations for use of portableelectro-optical medical devices.

Powering Up the System•

Turn ON the single power switch on the front of the KXL console. This switch
turns on all the system components.

Figure 3-1. Power Switch•

The KXL System begins a power-up sequence, loading the operating system
and all configuration and reference files.

•

Ensure that the System battery status indicator light is green.

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Figure 3-2. Startup Screen•

To begin patient treatment, press the Start New Treatment button.

•

Please see Section 3.17 for Power Down sequence instructions.

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

Set Riboflavin Induction Period•

Specify the desired Riboflavin Induction Period (1 sec – 30 min).

•

When finished entering parameters, press the Checkmark button.

Figure 3-3. Induction Period Screen

NOTE: Default treatment parameters will auto-populate user selectable fields
but are adjustable. Defaults settings can be changed (see Section 3.19.6, Editing
Default Treatment Parameters Screen).

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Select UV Treatment Mode
There are two UV treatment modes available, Continuous and Pulsed.
•

Continuous Mode: The UV output is constant for the duration of the UV
treatment.

•

Pulsed Mode: The UV output turns ON and OFF at user selected intervals.

3.1.3 Continuous UV Treatment Mode•

Select Continuous and press the Checkmark button.

Figure 3-4. Select Continuous Treatment Mode Screen•

Enter the desired UV treatment parameters:-

Total Energy:-

RFID card
UV Power:

User may select UV Energy in 0.1 J
increments. Range is controlled by the
3 mW/cm2 – 45 mW/cm2

NOTE: UV irradiation time is displayed in the orange box.
•

When finished entering treatment parameters, press the Checkmark button.

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Figure 3-5. Continuous UV Treatment Parameters Screen•

Confirm the specified treatment parameters by pressing the Checkmark. If
the treatment parameters are not correct, press the X and then re-enter thedesired treatment parameters.

Figure 3-6. Confirm Continuous Treatment Parameters Screen

3.1.4
•

Pulsed UV Treatment Mode
Select Pulsed and press the Checkmark button.

Figure 3-7. Select Continuous Treatment Mode Screen

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•

Enter the desired UV treatment parameters:-

Total Energy:-

UV Power:

User may select UV Energy in 0.1 J
increments. Range is controlled by
the RFID card.
15 mW/cm2 – 45 mW/cm2

NOTE: UV irradiation time is displayed in the orange box.

Figure 3-8. Pulsed UV Treatment Parameters Screen•

When finished entering treatment parameters, press the Checkmark button.

•

Select the desired times in which the UV is cycled ON and OFF.

•

When finished entering treatment parameters, press the Checkmark button.

Figure 3-9. Set Pulsed UV Cycle Times Screen

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Confirm the specified treatment parameters by pressing the Checkmark. If
the treatment parameters are not correct press the X and then re-enter thedesired treatment parameters.

Figure 3-10. Confirm Pulsed UV Treatment Parameters Screen

Starting Treatment•

Place the activation card on the RFID reader and hold in place until the systememits a beep.

Figure 3-11. Reading Activation Card

3.1.5
•

Single-use Disposables
Hold until read is complete and discard tag or activation card.

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3.1.6 Multi-use Disposables•

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

Figure 3-12. Treatments Remaining

Figure 3-13. Final Treatment

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Figure 3-14. No Treatments Remaining

3.1.7 RFID Card Controlled Limits•

If the user has previously programmed an UV Energy range that is outside theallowable value(s) controlled by the RFID card, an Invalid Treatment
Parameters message will appear.

Figure 3-15. Invalid Treatment Parameters•

Press the Back to Treatment Parameters button to enter the appropriate
parameter.

3.1.8 Sync Alignment Remote•

A Sync Alignment Remote window will appear before transitioning to the“Prepare for Treatment” window.

•

Press the “S” button on the remote to synchronize the remote within the 15
second window displayed on the screen. This is required for every procedure.

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Figure 3-16. Remote Sync Status

Remote Indicator Light Status

MeaningON

Actively synchronized with the device

Blinking once per second for 10 seconds

Disconnection sync (after procedure)

Blinking constantly, twice per second

Replace remote batteries immediately (2 AAA)NOTE: The KXL System performs an internal self-test prior to each treatment 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 local
Avedro technical service representative.

•

Annual preventative maintenance of the KXL System is not required because
the System performs an internal self-test prior to each eye being treated.

Preparing the Patient•

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

•

Adjust the table or chair and headrest so that the patient can rest comfortably
for the duration of the treatment without head movement.

•

Apply a lid speculum and optional drapes using standard clinical technique.

•

Apply Riboflavin to the area of treatment in accordance with the Riboflavin
Instructions for Use (IFU).

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KXL System Operator’s Manual | Page 24

CAUTION: Riboflavin (vitamin B2) is not a part of the KXL System describedin this manual. For details of component use, please refer to thecomponent’s Directions for Use.

Figure 3-17. Prepare Patient Screen

NOTE: Once the Riboflavin is applied to the eye, Start the induction by pressing
the “Riboflavin Applied: Start Timer” button.

Alignment of the Device•

KXL has two alignment lasers.
-•

Red crosshair for X and Y axis positioning.
A second red crosshair for Z axis positioning.

Ensure that the alignment lasers are visible prior to performing a treatment.

NOTE: For correct alignment when using the Remote, the Avedro logo on optics
head should face the user•

Manually move the Optics head back and forth and left and right until the redcrosshairs are aligned to the center of the pupil.

•

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

•

Fine tune the alignment as needed using the wireless remote.

•

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

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Figure 3-18. Align Crosshairs During Induction

Figure 3-19. Remote Functions

Figure 3-20. Red Crosshairs X & Y Axes, Red Crosshairs Z Axis Alignment

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Initiating Treatment•

Press the “Begin UV Treatment” button to initiate treatment.

Figure 3-21. Induction Complete

WARNING: Start treatments only after photosensitizer is applied.
WARNING: Make sure that the KXL System and the patient’s table or chair
are secured and not moved after alignment and during treatment.
CAUTION: UV light is emitted when the Avedro logo on the optical headchanges color from blue to green.
NOTE: The KXL system continuously monitors UVA levels during treatment.
•

The internal monitor uses a redundant set of optical sensors to ensure that
accurate levels of UVA are delivered throughout the treatment.

•

If the UVA levels deviate from the intended values, an error message will be
generated, and the treatment cannot proceed. If this occurs, contact your
distributor of local Avedro sales representative immediately.

Monitoring Treatment•

Check continuously that the area of interest on the cornea is illuminated with
the UV light and adjust as necessary using the wireless remote.

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Figure 3-22. Treatment 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 thesecycles.
•The patient should attempt to fixate on the red X & Y alignment crosshairthroughout the treatment.

•

Patients should remain still during the treatment.

Stopping a Treatment•

The treatment stops automatically after the user-programmed timer expires.

•

The user may decide to stop or interrupt the treatment. In such case, the UV
light can be switched OFF by pushing the Pause button.

•

If treatment is Paused, the System will emit a double beep every few seconds
as a reminder.

Figure 3-23. Treatment Paused Screen•

To cancel or resume treatment, press “Cancel Session” or “Resume” asappropriate. See Section 3.19 if canceling a session.

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Treatment Complete•

At the completion of a treatment, the Total Treatment Parameters will be
displayed, and the screen will show “Treatment Completed.”

Figure 3-24. Treatment Complete Screen•

Press “Start New Treatment” to exit treatment and / or start a newtreatment.

•

If treatments are complete, Power OFF the System using the “Power Off”
button on the Main Screen.

•

Carefully remove the device from the patient area.

•

Apply antibiotic ointment on the cornea and then cover cornea with abandage contact lens.

•Remove speculum.

•

Give post-op medication using a regimen similar to after photorefractive
keratectomy (PRK): pain medication, steroids, antibiotics.

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Pausing or Canceling a Treatment
Treatment may be paused at the discretion of the user. If a session is canceled, the screen
displays with “Confirm Cancel Session.”

Figure 3-25. Confirm Cancel Session Screen•

To cancel a session, press “Cancel Session.”•If the session is Paused, the screen displays “Confirm Cancel Partial
Treatment.”

Figure 3-26. Confirm Cancel Partial Treatment•

To cancel the session, press “Cancel Session.”

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KXL System Operator’s Manual | Page 30•

The screen displays “Partial Treatment Information.”

Figure 3-27. Partial Treatment Information

Powering Down the System
NOTE: It is recommended that the KXL System be plugged into an electricaloutlet when not in use or when stored.

Figure 3-28. Power Off•

Press the “Power Off” on the touch screen monitor.

•

Wait for the software to shut down - the screen will be blank.

Figure 3-29. Power Off Position•

Turn the system power switch to the “Off” position.

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Figure 3-30. KXL System Plug•If the KXL System is not already plugged in, plug the KXL System into an AC
outlet until next use.

Checking KXL System Battery Function after Storage
If the KXL System has not been plugged into an AC outlet or in use for a period of 3 months
or more, proceed as follows to determine the health of the KXL System battery.
•With the System fully powered down, plug the System into an AC outlet for
at least 8 hours.

•

After at least 8 hours of charging, observe the charge indicator LED light on
the side of the device main body.

•

If the indicator is green, the battery is healthy, and the System can be used as
normal.

Figure 3-31. KXL System Battery Status Indicator•

If the indicator is not green (yellow or orange/red), the battery may bedamaged. Do not use the System to treat patients. Contact your Avedro sales
representation or Customer Service.

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Using the Device Settings Menu•

With the Initialization screen (Start New Patient) displayed, press and holdthe KXL logo on the touchscreen.

Figure 3-32. Device Settings Menu

3.1.9 Advanced Settings•

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

3.1.10 Editing System Language•

The System Language option allows a user to select the language of theGraphical User Interface.

•

Select the desired language from the dropdown menu.

Figure 3-33. Edit System Language

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3.1.11 Editing Alignment Crosshairs Intensity•

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

•

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

Figure 3-34. Edit Alignment Crosshairs Intensity

3.1.12 Editing System Volume•

The Edit Volume option allows a user with the appropriate security level toedit the system volume level.

•

Select the Edit Volume button on the Device Settings menu.

Figure 3-35. Edit Volume

3.1.13 Copying Treatment Data to USB
WARNING: The USB port can only be used when the system is not intreatment mode. Do not have items connected to the USB during
treatment.

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KXL System Operator’s Manual | Page 34•

Select the Copy Treatment Data to USB button on the Device Settings menu.

Figure 3-36. Data Transfer to USB•

Insert a USB device to a USB port and then press the Copy treatment data to
USB button. The System begins transferring the treatment data and shows a
progress bar of the transfer process as shown in the screen below.

•

Once complete press the Return button. The System will return you to theDevice Settings menu.

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3.1.14 Editing Default Treatment Parameters•

The Edit Default Treatment Parameters option allows a user to set the default
treatment parameters that are displayed on entry to the Set Induction Timeand Set UV Parameters screens.

Figure 3-37. Edit Default UV Treatment Mode Parameters•

Press the Checkmark button to continue.

Figure 3-38. Edit Default Treatment Parameters (Continuous & Pulsed)

Figure 3-39. Edit Default UV Pulse Parameters (Pulsed Only)•

When treatment parameters are confirmed, press the Checkmark button toexit these Settings.

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4 Maintenance / Service
By definition, “maintenance” refers to those non-technical procedures an everyday
operator must perform to keep the system working properly. The word “service,” bycontrast, refers to tasks that are intended to be performed only by a qualified service
representative.

Installation Policy•

For each new KXL System, your Avedro-authorized distributor provides a fullinitial installation and start-up of the System. Following initial installation andonce the System is operating properly, the Avedro representative may also
provide basic training to a designated operator about the basic operation of
the KXL System.

•

Consequently, this manual does not include any specific instructions relating
to installation or set-up of the System. Per your service agreement, any
further hardware adjustment, other than what is specified for normal
operation, should be performed by, or with the guidance of, an Avedroauthorized distributor.

Customer Maintenance•In general, there is no customer maintenance required for the KXL System. All
technical maintenance or service will be performed by a qualified service
representative while under service contract. If you have trouble with yoursystem, refer to the troubleshooting section below or call your local Avedro
Representative.

Warranty Information•

A Warranty is supplied separately with the purchasing information.

Service Contract Information•

A service contract is available on all KXL Systems. The contract provides forregularly scheduled maintenance. It also provides for any non-scheduled
service calls that may be necessary.

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Per Patient Disposables•

Per Patient Disposables can be ordered from Avedro or your Avedroauthorized distributor. Use only Avedro products or Avedro-approved
products with your KXL System. Avedro shall not be liable for damage to or
malfunction of the system, which it deems, was caused by the use ofunauthorized materials.

Troubleshooting•

The KXL System checks its status at start-up automatically. If the status isincorrect, the software prevents the operator from initiating treatments
when the System is in normal operating state.

4.1.1

Wireless Remote•

The KXL System uses a remote control with replaceable batteries. If thebatteries run low, the system will lose its connection with the remote andnotify the user of the need to re-synchronize. The user will not be able toinitiate a procedure.

•

If the remote synchronization is lost during a treatment, the user will beprompted to determine if they want to continue the treatment without the
remote.

Figure 4-1. Alignment Remote Lost Sync--

ML-00002 Rev 3

If light on the remote is flashing two times per second, theremote’s batteries need to be changed. If the light on the remote
is flashing once per second, then it is not synchronized.
If the remote does not re-synchronize by pressing the “Sync”
button, replace the batteries.
If replacing the batteries does not allow the System tosynchronize, contact your local Avedro Service Representative.

KXL System Operator’s Manual | Page 38

4.1.2 Internal Rechargeable Battery•

The KXL System is supplied with a rechargeable battery, if the system does
not appear to be turning on, ensure that the battery is charged by plugging it
into an outlet and checking the charging indicator on the column of thesystem. If the light is orange or yellow, the system is charging. If it is green, it
is fully charged.
-

If the indicator is green or yellow and the system still does notturn on, contact your local Avedro service representative.
If the indicator is red/orange, wait until it turns yellow or green
and try turning the system on. If it still does not turn on or theindicator does not go yellow or green after charging for at least 8hours, contact your local Avedro service representative.

Directions for Sterilization or Disinfection•

No components of the KXL System are designed to be sterilized by theoperator. External cleaning and disinfection ONLY is recommended. For
disinfection purposes, use only isopropyl alcohol spray or preparations. Use
small amounts of liquid and soft fiber-free wipes.

Cleaning the System
CAUTION: Remove the power supply cord from the main outlet and turn off
the power switch prior to any cleaning procedure.
CAUTION: Aggressive cleaning agents, especially those containing abrasives
or aggressive solvents can damage component surfaces.
•

Use a soft damp cloth to clean the system.

•

The exterior of the KXL System can be cleaned using a lint-free cloth
dampened with isopropyl alcohol.

•

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

•

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 remotecontrol.

Cleaning the Aperture
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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•

Check the beam aperture routinely prior to treatment.

•

Use special camera lens wipes or compressed air to remove dust and particles
from the glass surface of the aperture.

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 the articulating arm.
•

Press the arm down to approximately parallel to the floor.

Figure 4-2. Position the Arm Parallel to the Floor•

If the arm drifts upward, turn the adjustment screw clockwise using a 7/32”
Allen Wrench. See Figure 4-2.

•

If the arm drifts downward, turn the adjustment screw counterclockwise
using a 7/31” Allen Wrench. See Figure 4-2.

NOTE: 15-20 turns may be needed.

Figure 4-3. Turn the Adjustment Screw

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KXL System Operator’s Manual | Page 40

In some instances, further counterbalance adjustments are needed to allow thearm’s instant height adjustment function to work properly.
If your arm is not staying in position after performing the above steps, performthe following steps:
NOTE: Do not over tighten screws.
•

With arm in a raised position, tighten set screw (A) with a 3/32” Allen Wrench.

Figure 4-4. With Arm Raised, Tighten Set Screw (A)•With arm in a horizontal position, tighten set screw (B) with a 3/32” Allen
Wrench.

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Figure 4-6. Summary of Further Counterbalance Adjustments•

If you continue to have issues with the articulating arm after following theabove steps, contact your local Avedro service representative.

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Moving the System•

The KXL is designed as a movable system within an office environment. If it
ever proves necessary to transport or ship the KXL System, for any reason,contact your local Avedro representative. Packing and transporting thesystem should be performed only by Avedro trained and authorized
personnel.

•

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

Figure 4-7. Moving System Configuration

Storing the System•

Follow all the storage temperature and humidity range specifications as listed
in the Specifications, Section 7.

•

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

•

Turn OFF all the components and the main power supply as well. It is
recommended that the System remain plugged into an electrical outlet if not
being used for more than 3 months.

•

Remove the batteries from the wireless remote.

•Cover the touch screen LCD display and keyboard with its original cover orpackaging to prevent any damage.

•

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

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

Identifying Risks Associated with Disposing of Waste Products•

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

Performing a Visible Check•

Check all components of the System routinely for damage or malfunction
prior to each treatment.

•

Do not use a damaged or malfunctioning System. Use of such a System mayharm the user and/or patient.

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5 Equipment Classification
Equipment Classification
According to IEC60601-1 Medical Device Electrical Standard•

Protection against electrical shock-•

Degree of protection against electric shock-•

Disinfectable device

Degree of protection for use in the presence of a flammable anesthetic
mixture-•Not classified, equipment not provided with applied part
Ingress protection: IP20

Method of sterilization or disinfection-•

Class 1 (external electrical power source)Internally powered equipment (internal battery operation)

No protection

Use conditions-

Continuous service

According to FCC Part 15, IEC55011 and IEC60601-1-2•Class B

According to IEC60825-1 Safety of laser productions•

Alignment lasers are Class 1 Laser ProductAccording to IEC62471 Photobiological safety of lamps and lamp systems•

UVA LED is Risk Group 1

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EMC Guidance
The KXL System requires special precautions regarding
electromagnetic compatibility (EMC). Installation and use should
be carried out according to the EMC information provided in thismanual. Portable and mobile RF communications equipment may
affect the KXL System.

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

Emissions test
RF emissions

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

Class BThe KXL UV Illumination System is suitable for use in all
establishments other than domestic, and may be used indomestic establishments and those directly connected to the
public low-voltage power supply network that supplies
buildings used for domestic purposes, provided the following
warning is heeded:

CISPR 11
RF emissions
CISPR 11
Harmonic emissions

Class AIEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3

Electromagnetic environment — guidanceComplies

Warning: This equipment/system is intended for use byhealthcare professionals only. This equipment/system maycause radio interference or may disrupt the operation of
nearby equipment. It may be necessary to take mitigation
measures, such as re-orienting or relocating the KXL UVIllumination System or shielding the location.

Table 5-1. Electromagnetic Emissions

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

Immunity test

IEC 60601
test level

Electrostatic
discharge (ESD)
IEC 61000-4-2±6 kV contact±6 kV contact±8 kV air

±8 kV airElectrical fasttransient/burst
IEC 61000-4-4±2 kV for power
supply lines±2 kV for power
supply lines±1 kV for
input/output lines

Not ApplicableSurge
IEC 61000-4-5

Voltage dips, shortinterruptions andvoltage variations
on power supply
input lines
IEC 61000-4-11±1 kV line(s) toline(s)±1 kV line(s) toline(s)±2 kV line(s) toearth<5 % UT

0% UT for 0.5
cycles

40% UT(60% dip in UT) for
5 cycles
70% UT(30% dip in UT) for
25 cycles<5% UT(>95 % dip in UT)
for 5 sec

Floors should be wood, concrete or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be atleast 30%.

Mains power quality should be that of atypical commercial or hospital environment.

Input /Output Lines±2 kV line(s) toearth(>95 % dip in UT)
for 0.5 cycle

Electromagnetic environment guidanceCompliance level

40% UT for 5
cycles
70% UT for 25/30
cyclesMains power quality should be that of atypical commercial or hospital environment.

Mains power quality should be that of atypical commercial or hospital environment,
If the user of the KXL UV Illumination System
requires continued operation during power
mains interruptions, it is recommended that
the KXL UV Illumination System be poweredfrom an uninterruptible power supply or abattery.

0% UT for 250/300
cyclesPower frequency(50/60 Hz)
magnetic field

3 A/m

3 A/m

Power frequency magnetic fields should be
at levels characteristic of a typical location ina typical commercial or hospitalenvironment.

IEC 61000-4-8
NOTE UT is the a.c. mains voltage prior to application of the test level.

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Table 5-2. Electromagnetic Immunity

Guidance and manufacturer’s declaration electromagnetic immunity—

The KXL UV Illumination System is intended for use in the electromagnetic environment specified below.
The customer or the user of the KXL UV Illumination System should assure that it is used in such an environment.

Immunity test

IEC 60601 test level

Compliance
level

Electromagnetic environment — guidancePortable and mobile RF communications equipment should be
used no closer to any part of the KXL UV Illumination System,
including cables, than the recommended separation distancecalculated from the equation applicable to the 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 2.5 GHz

Immunity test

IEC 60601 test level

3 Vrmsd = 1.2 P

3 V/m

d = 1.2 P

80 MHz to 800 MHz

d = 2.3 P

80 MHz to 2.5 GHz

Compliance
level

Electromagnetic environment — guidance
where P is the maximum output power rating of thetransmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should beless than the compliance level in each frequency range.b
Interference may occur in the vicinity of equipment
marked with the following symbol:

NOTE 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 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 theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should beconsidered. If the measured field strength in the location in which the KXL UV Illumination System is used exceeds the applicable RF compliance level above, the KXL UVIllumination 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 UV Illumination System.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Table 5-3. Electromagnetic Immunity (continued)

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Recommended separation distances between portable and mobile RF communications equipment andthe KXL UV Illumination System
The KXL System is intended for use in an electromagnetic environment in which radiated 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 UV Illumination System asrecommended below, according to the maximum output power of the communications equipment.

Separation distance according to frequency of transmitter (m)Rated maximum
output power oftransmitter (W)150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2.5 GHz

d = 1.2 P

d = 1.2 P

d = 2.3 P

0.01

0.12

0.12

0.23

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

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) canbe estimated using the equation 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 and people.

Table 5-4. Recommended Separation Distances

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RF Transmitters
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 if that otherequipment complies with CISPR emission requirements.

5.1.1 RFID Reader•

13.56MHz Reader/Writer•

Integral Antenna: Maximum 4” Read Range•

US/FCC number SX90RFID1•

Max output power is 200mW•

Meets: ISO18000-3, ISO15693

The highest emissions generated by the above equipment are listed below:
Fundamental

Frequency(MHz)

Paragraph 15.225(a)13.56 (peak)Level(dB µV/m)
at 30 m29.8

Limit
(dB µV/m)
at 30 m84

Limit(µV/m)
at 30 m
15,848Margin (dB)
-54.2

Harmonics

Frequency(MHz)
27.12 (peak)Level(dB µV/m)
-5.2

Limit
(dB µV/m)
29.5

Spurious

200.6 (peak)

34.5

40.0

-5.5

Conducted

0.199 (avg)

38.8

54.6

-15.8

Other

Table 5-5. Highest Emissions

5.1.2 Wireless Remote Control•

FCC ID SXJ87027-TX•

Frequency Range 2405MHz to 2475MHz•

Emissions Compliant with 47 CFR Part 15

ML-00002 Rev 3

Margin (dB)
-34.7

KXL System Operator’s Manual | Page 50

6 Symbol Library
Text Symbol

Symbol Illustration

Definition

1. No AP symbol in presence offlammable anesthetics

Danger, Risk of Explosion. Not foruse

2. AC symbol

Alternating current

3. “I” in a bookAttention: Consult
ACCOMPANYING
DOCUMENTS

4. Ground symbol in circle

Protected earth (ground)

5. Power Switch

ON

6. Power Switch

OFF

7. Fuse symbol

Fuse

8. Manufacturer

Name and address of the
manufacturer

9. ! in a Triangle

Caution specific warning inoperators manual

10. Net Weight (kgs)
Gross Weight (kgs)

NW
GW

Weight

11. Umbrella with raindrops

Keep Dry: Store protected frommoisture (symbol is with orwithout rain drops)

12. Wine glass with crack on itContents are fragile, handle withcareor
13. Two up arrows

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Text Symbol

Symbol Illustration

Definition

14. Water drop in a box

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

15. Temperature limits

Temperature shipment limits

16. MR crossed in a circle

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

17. Signal emittedThis device includes RFtransmitters

18. Pressure limits

Atmospheric pressure limits(storage / operating)

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7 Specifications
Specification

Description

ElectricalBattery Powered: 12V 35 Ah SLALine voltages 100 – 240 volts AC
Current: 2A – 1A
Single Phase
RMS, 50/60 Hz
Remote 2x AAA batteries

User accessible Fuses

250 V~ T2AH

Energy Delivery

UV Radiation3 – 45 mW/cm2 ±10%365 nmUVA LED Light Source

UV Radiation
365 nmExternal Interfaces

USB 2.0

Physical Dimensions

No larger than 60 x 60 x 150 cm3 (Length x
Width x Height)
NW 45 Kg
GW 120 Kg
16 hours

Weight (crated system)
System Battery Life
(normal operating conditions)Remote Battery Life
(normal operating conditions)
Environmental Operating Conditions
Ambient temperature
Relative humidity
Atmospheric pressure
Transport and Storage Conditions

Ambient temperature
Relative humidity
Atmospheric pressure

ML-00002 Rev 3

18 hours
The system operates under the following
atmospheric conditions (no condensation).
+10 to +40 ºC
30% to 75%, non-condensing
700 to 1060 mbar
The instrument withstands the following
transport and storage conditions without
damage or performance deterioration.
-15 to +70 ºC
10% to 100% non-condensing
500 to 1060 mbar