Avedro, Inc.
KXL® System
Operator’s Manual

Copyright 2019. All Rights Reserved.
Printed in U.S.A.

KXL System Operator’s Manual
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Patents, Trademarks, Copyrights
The KXL System may be covered by one or more patent applications
issued or pending in the United States and worldwide.
“KXL” and the Avedro logo design are registered trademarks ortrademarks of Avedro, Inc. All software and documentation is subject toAvedro, Inc. copyrights. All rights reserved 2019.
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

Authorized Representative
EMERGO EUROPE
Prinsessegracht 202514 AP, The Hague
The Netherlands
Phone: +31.70.345.8570
Fax: +31.70.346.7299

2797

KXL System Operator’s Manual
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Table of Contents
1

2

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 ........................................................................................................... 2

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........................................................................................... 5

1.7

Patient Safety .................................................................................................................................. 5

1.8

Additional Safety Considerations .......................................................................................... 5

1.9

FCC Compliance Notice ............................................................................................................. 5

Introduction ....................................................................................................................................... 7
2.1

System Overview ........................................................................................................................... 7
2.1.1

3

Major Components ...........................................................................................................8

System Operation............................................................................................................................ 11
3.1

Charging the KXL System Battery........................................................................................11

3.2

Touchpad/Keyboard Use ........................................................................................................ 12

3.3

UV Dose ............................................................................................................................................ 13
3.3.1

Continuous Mode ........................................................................................................... 13

3.3.2

Pulsed Mode .................................................................................................................... 13

3.4

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

3.5

Important Steps Before Turning on the System.......................................................... 14

3.6Powering Up the System ......................................................................................................... 14

3.7

Set Riboflavin Induction Period ............................................................................................ 15

3.8

Select UV Treatment Mode .................................................................................................... 16

3.9

3.8.1

Continuous UV Treatment Mode ........................................................................... 16

3.8.2

Pulsed UV Treatment Mode .................................................................................... 17

Starting Treatment...................................................................................................................... 19
3.9.1

Single-use Disposables ............................................................................................... 19

3.9.2

Multi-use Disposables ................................................................................................ 20

3.9.3

RFID Card Controlled Limits ................................................................................... 21

3.9.4

Sync Alignment Remote ........................................................................................... 21

3.10

Preparing the Patient ................................................................................................................ 22

3.11

Alignment of the Device ......................................................................................................... 23

3.12

Initiating Treatment ................................................................................................................... 25

3.13

Monitoring Treatment .............................................................................................................. 25

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5

3.14

Stopping a Treatment .............................................................................................................. 26

3.15

Treatment Complete ................................................................................................................. 27

3.16

Pausing or Canceling a Treatment..................................................................................... 28

3.17Powering Down the System.................................................................................................. 29

3.18

Checking KXL System Battery Function after Storage .......................................... 30

3.19

Using the Device Settings Menu .......................................................................................... 31
3.19.1

Advanced Settings ...................................................................................................... 31

3.19.2

Editing System Language ....................................................................................... 31

3.19.3

Editing Alignment Crosshairs Intensity ........................................................... 32

3.19.4

Editing System Volume .......................................................................................... 32

3.19.5

Copying Treatment Data to USB ....................................................................... 32

3.19.6

Editing Default Treatment Parameters ........................................................... 34

Maintenance / Service ................................................................................................................. 35
4.1

Installation Policy ........................................................................................................................ 35

4.2

Customer Maintenance ............................................................................................................ 35

4.3

Warranty Information ............................................................................................................... 35

4.4

Service Contract Information ............................................................................................... 35

4.5

Per Patient Disposables ........................................................................................................... 36

4.6

Troubleshooting .......................................................................................................................... 36
4.6.1

Wireless Remote ........................................................................................................... 36

4.6.2

Internal Rechargeable Battery .............................................................................. 37

4.7

Directions for Sterilization or Disinfection ..................................................................... 37

4.8

Cleaning the System ................................................................................................................. 37

4.9

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

4.10

Articulating Arm Adjustment ............................................................................................... 38

4.11

Moving the System ..................................................................................................................... 41

4.12

Storing the System ..................................................................................................................... 41

4.13

Software .......................................................................................................................................... 42

4.14

Identifying Risks Associated with Disposing of Waste Products ...................... 42

4.15

Performing a Visible Check ................................................................................................... 42

Equipment Classification ........................................................................................................... 43
5.1

Equipment Classification ........................................................................................................ 435.2

EMC Guidance ..............................................................................................................................44

5.3

RF Transmitters ........................................................................................................................... 48
5.3.1

RFID Reader ..................................................................................................................... 48

5.3.2

Wireless Remote Control ......................................................................................... 48

6

Symbol Library .............................................................................................................................. 49

7

Specifications ................................................................................................................................... 51

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Table of Figures
Figure 2-1. Overview Illustration of KXL 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. Alignment Laser Classification Label ................................................................................. 10
Figure 3-1. Power Switch ................................................................................................................................... 14
Figure 3-2. Startup Screen ............................................................................................................................... 15
Figure 3-3. Induction Period Screen............................................................................................................ 15
Figure 3-4. Select Continuous Treatment Mode Screen .................................................................. 16
Figure 3-5. Continuous UV Treatment Parameters Screen ............................................................. 17
Figure 3-6. Confirm Continuous Treatment Parameters Screen .................................................. 17
Figure 3-7. Select Continuous Treatment Mode Screen ................................................................... 17
Figure 3-8. Pulsed UV Treatment Parameters Screen ....................................................................... 18
Figure 3-9. Set Pulsed UV Cycle Times Screen ..................................................................................... 18
Figure 3-10. Confirm Pulsed UV Treatment Parameters Screen .................................................. 19
Figure 3-11. Reading Activation Card .......................................................................................................... 19
Figure 3-12. Treatments Remaining ............................................................................................................ 20
Figure 3-13. Final Treatment ........................................................................................................................... 20
Figure 3-14. No Treatments Remaining ..................................................................................................... 21
Figure 3-15. Invalid Treatment Parameters .............................................................................................. 21
Figure 3-16. Remote Sync Status ................................................................................................................. 22
Figure 3-17. Prepare Patient Screen ........................................................................................................... 23
Figure 3-18. Align Crosshairs During Induction .................................................................................... 24
Figure 3-19. Remote Functions ..................................................................................................................... 24
Figure 3-20. Red Crosshairs X & Y Axes, Red Crosshairs Z Axis Alignment ........................ 24
Figure 3-21. Induction Complete .................................................................................................................. 25
Figure 3-22. Treatment Screen ..................................................................................................................... 26
Figure 3-23. Treatment Paused Screen .................................................................................................... 26
Figure 3-24. Treatment Complete Screen .............................................................................................. 27
Figure 3-25. Confirm Cancel Session Screen ......................................................................................... 28
Figure 3-26. Confirm Cancel Partial Treatment.................................................................................... 28
Figure 3-27. Partial Treatment Information ............................................................................................ 29
Figure 3-28. Power Off ...................................................................................................................................... 29
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Figure 3-29. Power Off Position ................................................................................................................... 29
Figure 3-30. KXL System Plug ......................................................................................................................30
Figure 3-31. KXL System Battery Status Indicator..............................................................................30
Figure 3-32. Device Settings Menu .............................................................................................................. 31
Figure 3-33. Edit System Language ............................................................................................................ 31
Figure 3-34. Edit Alignment Crosshairs Intensity................................................................................ 32
Figure 3-35. Edit Volume ................................................................................................................................. 32
Figure 3-36. Data Transfer to USB .............................................................................................................. 33
Figure 3-37. Edit Default UV Treatment Mode Parameters ........................................................... 34
Figure 3-38. Edit Default Treatment Parameters (Continuous & Pulsed) .............................. 34
Figure 3-39. Edit Default UV Pulse Parameters (Pulsed Only) .................................................... 34
Figure 4-1. Alignment Remote Lost Sync ................................................................................................ 36
Figure 4-2. Position the Arm Parallel to the Floor .............................................................................. 38
Figure 4-3. Turn the Adjustment Screw................................................................................................... 39
Figure 4-4. With Arm Raised, Tighten Set Screw (A)....................................................................... 39
Figure 4-5. With Arm Horizontal, Tighten Set Screw (B) ............................................................... 39
Figure 4-6. Summary of Further Counterbalance Adjustments ................................................. 40
Figure 4-7. Moving System Configuration ............................................................................................... 41
Table 5-1. Electromagnetic Emissions .......................................................................................................44
Table 5-2. Electromagnetic Immunity ....................................................................................................... 45
Table 5-3. Electromagnetic Immunity (continued) ............................................................................ 46
Table 5-4. Recommended Separation Distances ................................................................................ 47
Table 5-5. Highest Emissions ......................................................................................................................... 48

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1 Foreword
1.1

Intended Use of ManualThis manual is designed to serve the operators of the Avedro, Inc. KXL®
System. All operating instructions, product illustrations, screen graphics,
troubleshooting/error messages, and other relevant information 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, informationin this manual is subject to change without notice. Avedro, Inc.
(hereafter called “Avedro”) reserves the right to change
product design at any time without notice, which may
subsequently affect the contents of this manual.

•

Avedro assumes no responsibility for any errors that may
appear in this manual. Avedro will make every reasonable effort
to ensure that this manual is up to date and corresponds withthe shipped KXL System.

•

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

•All patient data appearing in this document, including thesample screen graphics, are fictitious and representative only.
No patient’s confidentiality has been violated, with or without
permission.

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1.4

Reproduction Disclaimer

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

1.5

User Operation Assistance Statement

Should you experience any difficulty in running your KXL System, 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
used because the risk of use clearly outweighs any possible benefit.
Conditions that may contraindicate the use of the device include:•

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

•

Corneal melting disorders•

Aphakic patients•

Pseudophakic patients without UV blocking lens implanted•

Pregnant and nursing women•Children

1.6.2

Warnings

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

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

Epithelial healing disorders

1.6.3

Electrical Safety WarningsThisequipment
requiresspecialprecautions
regardingelectromagnetic compatibility (EMC). Installation and use should be
carried out according to the EMC information provided in thismanual.
Portable and mobile RF communications equipment can affectmedical electrical equipment such as the Avedro KXL System.
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For Equipment Classifications, please refer to Chapter 5.0
Equipment Classifications.
WARNING: To avoid the risk of shock this equipment must
only be connected to a supply mains with protective earth.
Even with the power cord removed, there is the potential
for an electrical shock from the 12VDC internal powersource.
The system is designed for continuous operation using theexternal 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. Ensure that allservice to the system, beyond what is described in thismanual, including to the rechargeable battery, is performed
only by qualified Avedro service personnel.
WARNING: Remove the wall plug and turn off the powerswitch before servicing or cleaning (disinfecting) theequipment.
Never pull cords to remove the power cord from the outlet.
Grasp the power 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 from the wall outlet.
WARNING: Do not use the instrument near water and be
careful not to spill liquids on any part of it.

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WARNING: The USB port can only be used when thesystem is not in treatment mode,. Do not connect to theUSB during treatment.
WARNING: Do not operate the KXL System in the presenceof flammable mixtures or anesthetics.
WARNING: Never look directly into the UV light beam.
Never direct the beam towards a person except fortherapeutic purposes.
WARNING: The remote contains replaceable batteries; If
system is not going to be used for an extended period oftime, remove the batteries.
WARNING: Do not use adjacent to or stack with otherequipment; if it is used adjacent to or stacked with otherequipment, verify that the equipment behaves normally as
intended.
WARNING: No modification of this equipment is allowed.
WARNING: MR Unsafe – Keep away from magnetic
resonance imaging equipment.

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1.6.1 Radiation Safety Warnings
WARNING: Never look directly into the UV light beam nor
direct the beam towards a person except for therapeutic
purposes.
WARNING: Always wear UVA protective goggles when the
KXL system is turned on.
WARNING: Use only laser grade instruments in order toprevent reflected UV radiation from smooth metallic
surfaces.

1.7

Patient Safety

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

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

•

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

1.8

1.9

Additional Safety Considerations•

Any modification of the system's external light beam by meansof optical elements is strictly prohibited.

•

Plastic instrumentation such as speculums or eye shields may
be damaged when impacted by the UV beam, possibly resulting
in product degradation.

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.

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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 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 moreof 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 inorder to meet FCC emission limits. Proper cables and connectors areavailable 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
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. UVflux and irradiation time (that is, fluence) at the cornea are controlled byan onboard computer system.
The Optics Head houses the UVA irradiation mechanism. The LED ispreset 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 circular area of irradiation at the treatment plane with adiameter of 9 mm. Alignment lasers are used to aid the user in focusing
the beam on the patient’s cornea. Fine alignment of the UV beam throughobservation of the alignment lasers is controlled by the user through awireless remote. Treatment power is selectable by the user from 3
mW/cm2 to 45 mW/cm2 in 1 mW/cm2 increments. Total Energy isselectable in 0.1 J increments on the user interface, but the actual limits
are controlled by the RFID treatment card.
The KXL is a portable system with an articulating arm to allow movementof the system for alignment of the UV beam to the patient’s cornea. Aninternal battery powers the system; the battery is recharged by a systeminternal charger from any standard AC outlet. The treatment parameters(Riboflavin Induction Period, Total UV Energy, UV Power, 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 this manual 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 (disposablesupplied 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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KXL System Operator’s Manual | Page 10

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
3.1

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 be connected to a grounded mains supply at all times or at
the end of each business day, including when not in use.

•

The charging status of the battery is identified by the color of
the light located on 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 thebattery needs to be charged.

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

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3.2

Touchpad/Keyboard Use

The table below identifies and describes important touchpad keys andicons 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 tothe internal computer.

Start New Treatment
button (Initial screen)

Starts a new clinicaltreatment protocol.

UP arrow(various Clinical Protocol
screens)

Increases the value of thecurrent field.

DOWN arrow(various Clinical Protocol
screens)

Decreases the value of thecurrent field.

X button(various Device Settings
screens)

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

Checkmark button(various Clinical Protocol
screens and Device
Settings screen)

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

Cancel Session button(various Clinical Protocol
screens)

Cancels a treatment session
for a particular patient. A
prompt is then displayed toconfirm your decision.

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

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

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UV Dose•The UV Energy (Dose) is the product of the UV Power(Irradiance) and the UV Irradiation Time. The UV Energy and UVPower are adjustable and the calculated UV Irradiation Time isdisplayed.

•

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

•

There are two UV treatment modes available, Continuous andPulsed.

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

Continuous Mode Parameters:-

Induction Period: 1 second – 30 minutes
Wavelength:
365 nmUV Energy:
Controlled by the RFID card; User
may select in 0.1 J increments
UV Power:3 – 45 mW/cm2

3.3.2 Pulsed ModeIn Pulsed Mode, UV output turns ON and OFF at user selectedintervals•

Pulsed Mode Parameters:-

Induction Period: 1 second – 30 minutes
Wavelength:
365 nmUV Energy:
Controlled by the RFID card; User
may select in 0.1 J increments
UV Power:
15 – 45 mW/cm2
UV ON Time:
1.0 – 4.0 seconds
UV OFF Time:
1.0 – 4.0 seconds

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

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3.4 Preparing the System

3.5•

Position the KXL System adjacent to the treatment table orchair. Lock the casters to secure the device’s position.

•

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 isfunctioning properly and is in good working condition before
starting a treatment.

•

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

3.6

Inspect the device, accessories, and connecting cables
for visible damage.
Take into consideration your local regulations for useof portable electro-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 theoperating 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.

3.7

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 bechanged (see Section 3.19.6, Editing Default Treatment
Parameters Screen).

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3.8

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 selectedintervals.

3.8.1 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:-

UV Power:

User may select UV Energy in 0.1 J
increments. Range is controlled by
the RFID card
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 theCheckmark. If the treatment parameters are not correct, press
the X and then re-enter the desired treatment parameters.

Figure 3-6. Confirm Continuous Treatment Parameters Screen

3.8.2 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 theCheckmark. If the treatment parameters are not correct press
the X and then re-enter the desired treatment parameters.

•

Figure 3-10. Confirm Pulsed UV Treatment Parameters Screen

3.9

Starting Treatment•

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

Figure 3-11. Reading Activation Card

3.9.1
•

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

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3.9.2 Multi-use Disposables•

Once a multi-use activation card has been scanned, the display
will show the number 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

3.9.3 RFID Card Controlled Limits•

If the user has previously programmed an UV Energy range thatis outside the allowable 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 theappropriate parameter.

3.9.4 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 remotewithin the 15 second window displayed on the screen. This isrequired 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 eachtreatment to verify proper UVA calibration.
•

The internal self-test uses a redundant set of optical sensors toensure that accurate levels of UVA will be delivered for eachtreatment.

•

If the internal self-test fails, an error message will be generated,
and the treatment 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.

3.10 Preparing the Patient•

Ensure that the patient is lying flat or reclined on a patient tableor 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 clinicaltechnique.

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Apply Riboflavin to the area of treatment in accordance with
the Riboflavin Instructions for Use (IFU).
CAUTION: Riboflavin (vitamin B2) is not a part of the KXL
System described in this manual. For details of component
use, please refer to the component’s Directions for Use.

Figure 3-17. Prepare Patient Screen

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

3.11 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, theAvedro logo on optics head should face the user•

Manually move the Optics head back and forth and left and right
until the red crosshairs 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
crosshair throughout 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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3.12 Initiating Treatment•

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

Figure 3-21. Induction Complete

WARNING: Start treatments only after photosensitizer isapplied.
WARNING: Make sure that the KXL System and thepatient’s table or chair are secured and not moved afteralignment and during treatment.
CAUTION: UV light is emitted when the Avedro logo on the
optical head changes 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 toensure that accurate levels of UVA are delivered throughout thetreatment.

•

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.

3.13 Monitoring Treatment•

Check continuously that the area of interest on the cornea isilluminated with the UV light and adjust as necessary using thewireless 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 notchange to “UV is OFF” during these cycles.
•

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

•

Patients should remain still during the treatment.

3.14 Stopping 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
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” as appropriate. See Section 3.19 if canceling a session.

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3.15 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
new treatment.

•

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 a bandage 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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3.16 Pausing or Canceling a Treatment
Treatment may be paused at the discretion of the user. If a session iscanceled, 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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The screen displays “Partial Treatment Information.”

Figure 3-27. Partial Treatment Information

3.17 Powering Down the System
NOTE: It is recommended that the KXL System be plugged into
an electrical outlet 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.

3.18 Checking KXL System Battery Function after Storage
If the KXL System has not been plugged into an AC outlet or in use for aperiod of 3 months or more, proceed as follows to determine the healthof 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 be damaged. Do not use the System to treat patients.
Contact your Avedro sales representation or Customer Service.

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3.19 Using the Device Settings Menu•

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

Figure 3-32. Device Settings Menu

3.19.1 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 to scan an access card.

3.19.2 Editing System Language•

The System Language option allows a user to select thelanguage of the Graphical User Interface.

•

Select the desired language from the dropdown menu.

Figure 3-33. Edit System Language

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3.19.3 Editing Alignment Crosshairs Intensity•

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

•

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

Figure 3-34. Edit Alignment Crosshairs Intensity

3.19.4 Editing System Volume•

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

•

Select the Edit Volume button on the Device Settings menu.

Figure 3-35. Edit Volume

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

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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 the Device Settings menu.

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3.19.6 Editing Default Treatment Parameters•

The Edit Default Treatment Parameters option allows a user to
set the default treatment parameters that are displayed onentry to the Set Induction Time and 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,
Checkmark button to exit these Settings.

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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, your Avedro-authorized distributor
provides a full initial installation and start-up of the System.
Following initial installation and once 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 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
performed by, or with the guidance of, an Avedro-authorized
distributor.

4.2 Customer Maintenance•In general, there is no customer maintenance required for the
KXL System. All technical maintenance or service will be
performed by a qualified service representative while underservice contract. If you have trouble with your system, refer tothe 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 maintenance. It also provides
for any non-scheduled service calls that may be necessary.

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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 not be liable for damage to or malfunction of the system,
which it deems, was caused by the use of unauthorizedmaterials.

4.6 Troubleshooting•

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

4.6.1 Wireless Remote•

The KXL System uses a remote control with replaceable
batteries. If the batteries run low, the system will lose its
connection with the remote and notify the user of the need tore-synchronize. The user will not be able to initiate a procedure.

•

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

Figure 4-1. Alignment Remote Lost Sync--

ML-00002 Rev T

If light on the remote is flashing two times per second,
the remote’s batteries need to be changed. If the lighton 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.

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

4.6.2 Internal Rechargeable Battery•

The KXL System is supplied with a rechargeable battery, if thesystem does not appear to be turning on, ensure that thebattery is charged by plugging it into an outlet and checking
the charging indicator on the column of the system. If the lightis 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 not turn 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 the indicator does not go yellow or
green after charging for at least 8 hours, contact yourlocal Avedro service representative.

4.7 Directions for Sterilization or Disinfection•

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

4.8 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 thosecontaining 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 thesystem.

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

•

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

4.9 Cleaning the Aperture
CAUTION: The glass window of the beam aperture must notunder any circumstances be in contact with any aggressive
cleaning agents.
•

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.

4.10 Articulating Arm Adjustment
If the articulating arm does not hold the Optical Head in a fixedvertical 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.

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Figure 4-3. Turn the Adjustment Screw

In some instances, further counterbalance adjustments are needed
to allow the arm’s instant height adjustment function to work
properly.
If your arm is not staying in position after performing the above
steps, perform the 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 a3/32” 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 the above steps, contact your local Avedro service
representative.

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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 optics head should
be positioned close to the cart handle with the elbow protruding
at the back. The system can then be easily pushed by the cart
handle through the door frame.
Elbow at the back
UI monitor to the side
UV optical head nearhandleFigure 4-7. Moving System Configuration

4.12 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 moisturefrom 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 anelectrical 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 or packaging to prevent any damage.

•

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

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4.13 Software•

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

4.14 Identifying Risks Associated with Disposing of Waste
Products•

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

4.15 Performing a Visible Check•

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

•

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

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5 Equipment Classification
5.1

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 flammableanesthetic 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

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

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5.2

EMC Guidance
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 assurethat 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 and are not likely to cause
any interference in nearby electronic equipment.

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

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

Electromagnetic environment — guidanceWarning: This equipment/system is intended foruse by healthcare professionals only. Thisequipment/system may cause radio interferenceor may disrupt the operation of nearby
equipment. It may be necessary to takemitigation measures, such as re-orienting or
relocating the KXL UV Illumination System orshielding 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 assurethat it is used in such an environment.

Immunity test

IEC 60601
test level

Compliance
level

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

±8 kV airElectrical fast

±2 kV forpower supply
lines±2 kV for power
supply linestransient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips,
shortinterruptionsand voltage
variations on
power supply
input lines
IEC 61000-4-11±1 kV for
input/output
lines

Not Applicable
Input /Output
Lines±1 kV line(s) toline(s)±1 kV line(s) toline(s)±2 kV line(s) toearth±2 kV line(s) toearth<5 % UT

0% UT for 0.5
cycles(>95 % dip inUT) for 0.5
cycle
40% UT(60% dip in UT)
for 5 cycles
70% UT(30% dip in UT)
for 25 cycles

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

0% UT for250/300
cyclesPowerfrequency(50/60 Hz)
magnetic field

3 A/m

3 A/m

Electromagnetic environment guidance
Floors should be wood, concrete or
ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30%.

Mains power quality should be thatof a typical commercial or hospitalenvironment.

Mains power quality should be thatof a typical commercial or hospitalenvironment.

Mains power quality should be thatof a typical commercial or hospitalenvironment, If the user of the KXLUV Illumination System requires
continued operation during power
mains interruptions, it isrecommended that the KXL UVIllumination System be poweredfrom an uninterruptible power
supply or a battery.

Power frequency magnetic fields
should be at levels characteristic ofa typical location in a typicalcommercial or hospital environment.

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

Table 5-2. Electromagnetic Immunity

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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.

IEC 60601 test
level

Immunity test

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 thefrequency of the transmitter.
Recommended separation distance

Conducted RF 3 Vrms

3 Vrmsd = 1.2 P

3 V/m

d = 1.2 P 80 MHz to 800 MHz

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 testlevel

d = 2.3 P 80 MHz to 2.5 GHz

Compliance Electromagnetic environment — guidancelevel
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 meters(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
Interference may occur in the vicinity ofequipment 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 byabsorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM
and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due tofixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the KXL UVIllumination System is used exceeds the applicable RF compliance level above, the KXL UV Illumination 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 UVIllumination 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 RFcommunications equipment and the KXL UV Illumination System
The KXL UV Illumination System is intended for use in an electromagnetic environment in which radiatedRF disturbances are controlled. The customer or the user of the KXL UV Illumination 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 as recommended
below, according to the maximum output power of the communications equipment.

Separation distance according to frequency of transmitter (m)Ratedmaximum
output powerof transmitter(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) can be estimated using the equation applicable to the frequency of thetransmitter, 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 byabsorption and reflection from structures, objects and people.

Table 5-4. Recommended Separation Distances

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5.3

RF Transmitters5.3.1 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

Margin(dB)-34.7

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

5.3.2 Wireless Remote Control•

FCC ID SXJ87027-TX•

Frequency Range 2405MHz to 2475MHz•

Emissions Compliant with 47 CFR Part 15

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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. 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 withraindrops

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

12. Wine glass with crack
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Text Symbol

Symbol Illustration

Definition

13. Two up arrows

Keep arrows on carton
pointing up

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 awayfrom magnetic resonanceimaging (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 T

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