Avedro, Inc.
KXL System
Operator’s Manual

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

KXL Operator’s Manual Rev D
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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 is subject to Avedro, Inc. copyrights. All rights
reserved 2017.
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:Your Local Avedro-authorized distributor
Avedro, Inc.
201 Jones Road
Waltham, MA 02451

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

2797

KXL Operator’s Manual Rev D
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Table of Contents
Foreword ................................................................................................................................................. 1
1.1
Intended Use of Manual ....................................................................................................... 1
1.2
Intended Use / Indications for Use ....................................................................................... 1
1.3
Design Change Disclaimer .................................................................................................... 1
1.4
Reproduction Disclaimer ...................................................................................................... 1
1.5
User Operation Assistance Statement .................................................................................. 1
1.6
Contraindications, Warnings and Cautions ........................................................................... 2
1.6.1
Contraindications ................................................................................................. 2
1.6.2
Warnings .............................................................................................................. 2
1.6.3
Electrical Safety Warnings ..................................................................................... 2
1.7
Radiation Safety Warnings ................................................................................................... 5
1.8
Patient Safety....................................................................................................................... 5
1.9
Additional Safety Considerations .......................................................................................... 5
1.10
FCC Compliance Notice ........................................................................................................ 52

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

System Operation ........................................................................................................................... 11
3.1
Touchpad/Keyboard Use .................................................................................................... 11
3.2
UV Energy (Dose) ............................................................................................................... 14
3.3
Preparing the System ......................................................................................................... 15
3.4
Important Steps before Turning On the System .................................................................. 15
3.5Powering Up the System .................................................................................................... 15
3.6
Existing Patient Data .......................................................................................................... 16
3.7
Add New Patient ................................................................................................................ 17
3.8
Create New Treatment Plan ............................................................................................... 18
3.8.1
Select Eye to Treat .............................................................................................. 18
3.8.2
Select Treatment Type ........................................................................................ 19
3.8.3
Adjusting Treatment Parameters ........................................................................ 20
3.9
Select Treatment Mode...................................................................................................... 21
3.9.1
Continuous UV Mode.......................................................................................... 21
3.9.2
Pulsed UV Mode ................................................................................................. 22
3.10
Starting a Treatment .......................................................................................................... 23
3.10.1 Insert Treatment / RFID Activation Card .............................................................. 23
3.10.2 Single-use Activation Cards ................................................................................. 23
3.10.3 Multi-use Activation Cards .................................................................................. 24
3.10.4 RFID Card-controlled Limits................................................................................. 25
3.10.5 Sync Alignment Remote ...................................................................................... 27
3.11
Preparing the Patient ......................................................................................................... 29
3.11.1 Applying Riboflavin, Induction, and Alignment........................................................ 29
3.12
Initiating Treatment ........................................................................................................... 32
3.13
Monitoring Treatment........................................................................................................ 33
3.14
Pausing a Treatment .......................................................................................................... 33
3.15
Cancelling Mid-Treatment .................................................................................................. 34

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3.16
3.17
3.18
3.19
3.20

3.21
3.22

Capturing Images ............................................................................................................... 35
Treatment Complete .......................................................................................................... 37
Reviewing Images .............................................................................................................. 37
Deleting Photos.................................................................................................................. 38
Patient Treatment Report .................................................................................................. 39
3.20.1 Adding Notes to a Patient Treatment Report....................................................... 40
3.20.2 Exporting Treatment Report ............................................................................... 41
3.20.3 Viewing a Treatment Report ............................................................................... 44
Powering Down the KXL System ......................................................................................... 47
Accessing the System Settings Menu .................................................................................. 48
3.22.1 Service Settings .................................................................................................. 49
3.22.2 Selecting a Different System Language ................................................................ 49
3.22.3 Altering the Intensity of Alignment Crosshairs ..................................................... 50
3.22.4 Altering the System Volume ................................................................................ 51
3.22.5 Export Service Log .............................................................................................. 51
3.22.6 Altering Audible Beep Intervals ........................................................................... 52
3.22.7 Altering Camera White Balance........................................................................... 54

4

Maintenance / Service .................................................................................................................... 55
4.1
Installation Policy ............................................................................................................... 55
4.2
Customer Maintenance ...................................................................................................... 55
4.3
Warranty Information ........................................................................................................ 55
4.4
Service Contract Information.............................................................................................. 55
4.5
Per Patient Disposables ...................................................................................................... 55
4.6
Trouble Shooting................................................................................................................ 56
4.6.1
Wireless Remote................................................................................................. 56
4.7
Directions for Disinfection .................................................................................................. 57
4.8
Cleaning the System ........................................................................................................... 57
4.9
Cleaning the Aperture ........................................................................................................ 58
4.10
Articulating Arm Adjustment .............................................................................................. 58
4.11
Moving the System ............................................................................................................ 58
4.12
Storing the System ............................................................................................................. 59
4.13
Software ............................................................................................................................ 59
4.14
Risks Associated with Disposing of Waste Products ............................................................ 59
4.15
Performing a Visible Check ................................................................................................. 59

5

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

6

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

7

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

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

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

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

1.3 Design Change Disclaimer•

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

•

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

•

The computer display screens depicted in this manual are representative only.
Depending on the software version of the system, minor differences may
appear between the actual computer displays and those shown in this manual.

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

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

1.5 User Operation Assistance Statement
Should you experience any difficulty in running your KXL System, please contact your local
Avedro authorized representative.
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1.6 Contraindications, Warnings and Cautions
1.6.1 Contraindications
This section describes situations in which the device should not be used because the riskof use clearly outweighs any possible benefit. Conditions that may contraindicate the useof the device include:
•
•
•
•
•
•

Corneal thickness, with epithelium, of less than < 375 microns.
Corneal melting disorders
Aphakic patients
Pseudophakic patients without UV blocking lens implanted
Pregnant and nursing womenChildren

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

Herpes simplex, herpes zoster keratitis, recurrent corneal erosion, corneal
dystrophy
Epithelial healing disorders
In this manual, Caution is defined as: a statement that alerts the user to thepossibility of a problem with the device associated with its use or misuse. Suchproblems include device malfunction, device failure, damage to the device or
damage to other property. The caution statement includes the precaution thatshould be taken to avoid the hazard.

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

1.6.3 Electrical Safety Warnings••

This equipment requires special precautions regarding electromagnetic
compatibility (EMC). Installation and use should be carried out according to the
EMC information provided in this manual.
Portable and mobile RF communications equipment can affect medical electricalequipment such as the Avedro KXL System.
For Equipment Classifications please refer to Chapter 5.0 Equipment
Classifications.

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WARNING: 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 be connected
to a supply mains with protective earth.
To separate system connection to mains, grasp the power cord plug and pull
it from outlet to disconnect.
The system is designed for continuous operation using the external
connector.
WARNING: This equipment is operated with hazardous voltages that can
shock, burn, or cause death. To reduce the possibility of electrical shock, andinadvertent UVA exposure do not remove any fixed panels. Ensure that allservice to the system, beyond what is described in this manual, is performed
only by qualified Avedro authorized service personnel.
WARNING: Power down system and remove the wall plug before servicing or
cleaning (disinfecting) the equipment.
Never pull cords to remove the power cord from the outlet. Grasp the power
cord plug and pull it from the outlet to disconnect.
The equipment must be positioned so that it is not difficult to remove thepower cord from the outlet.
WARNING: Do not operate the equipment with a damaged power cord.
WARNING: Position the power cord so that it cannot be tripped over, walked
on, rolled over, crimped, bent, pinched, or accidentally pulled from the walloutlet.
WARNING: Do not use the instrument near water and be careful not to spill
liquids on any part of it.
WARNING: Do not operate the KXL System in the presence of flammablemixtures or anesthetics.

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WARNING: Never look directly into the UV light beam. Never direct the beam
towards a person except for therapeutic purposes.
WARNING: Ignoring local regulations on use of electro-optical medical
devices may cause malfunction due to electromagnetic interference.
WARNING: The remote contains replaceable batteries; if system is not going
to be used for an extended period of time remove the batteries.

WARNING: Use of not included accessories results in non-compliance of thedeviceWARNING: System may be interfered with by other equipment even if that
equipment complies with CISPR Emissions requirements. See Table 5-1.

WARNING: Use of this equipment adjacent to or stacked with otherequipment should be avoided because it could result in improper operation.
If such use is necessary, this equipment and the other equipment should beobserved to verify that they are operating normally.

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 (110-01019), including
cables specified by the manufacturer. Otherwise, degradation of theperformance of this equipment could result.

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

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

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1.7 Radiation Safety Warnings
WARNING: Use only laser grade instruments in order to prevent reflected UV
radiation from smooth metallic surfaces.
WARNING: UV emitted from this product. Avoid eye and skin exposure to
unshielded products. Never direct the beam towards a person except fortherapeutic purposes.

1.8

Patient Safety•

The treatment should take place in a quiet and relaxed atmosphere in order not to
distract the attention of the patient. The patient should lie on a table or patient's
chair. The patient’s head should rest comfortably in a headrest. It is imperativethat the table or patient’s chair or the system not be moved during the treatment
procedure.
CAUTION: The KXL System is a medical device. It may be operated, therefore,
only in health care facilities or medical areas under the supervision of
medically trained personnel.

1.9 Additional Safety Considerations•

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

•

Plastic instrumentation such as speculums or eye shields may be damaged when
impacted by the UV beam, possibly resulting in product degradation. Therefore,
only Avedro recommended accessories or stainless-steel surgical instruments
should be used.

•

Smooth metallic surfaces can reflect despite the effort to blank them. Therefore,
only laser grade instruments should be used.

1.10 FCC Compliance NoticeThis equipment has been tested and found to comply with the limits for a Class B digital
device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide
reasonable protection against harmful interference in a residential environment. Thisequipment generates, uses, and can radiate radio frequency energy and, if not installed
and used in accordance with the instruction manual, may cause harmful interference toradio communications. However, there is no guarantee that interference will not occur ina particular installation. If this equipment does cause harmful interference to radio or

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television reception, which can be determined by turning the equipment off and on, theuser is encouraged to try to correct the interference by one or more of the following
measures:•

Reorient or relocate the receiving antenna.

•

Increase the separation between the equipment and receiver.

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

•

Consult Avedro Customer Service for help.

•

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

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2 Introduction
2.1 System Overview
The KXL System is an electronic medical device which delivers ultraviolet light (365 nm
wavelength) in a circular pattern onto the cornea after a solution of Riboflavin has been
applied. Irradiating the Riboflavin creates singlet oxygen, which forms intermolecularbonds in corneal collagen, stiffening the cornea through cross-linking. UV flux andirradiation time (that is, fluence) at the cornea are controlled by an onboard computer
system.
The Optics Head houses the UVA irradiation mechanism and camera. The LED is presetby the manufacturer to emit UVA radiation at a wavelength of 365 nm at an intensity of
3 mW/cm2 to 45 mW/cm2.
A fixed aperture mounted in the UVA irradiation beam path is used to produce a
uniform circular area of irradiation at the treatment plane with an approximate
diameter of 9 mm. Alignment lasers are used to aid the user in focusing the beam on thepatient’s cornea. Fine alignment of the UV beam through observation of the alignment
lasers is controlled through a wireless remote and an internal drive system. Treatment
power is selectable by the user from 3 mW/cm2 to 45 mW/cm2 in 1 mW/cm2
increments. Total Energy is selectable in 0.1 J/cm2 increments on the user interface.
However, actual limits to power and energy are controlled by the RFID treatment card.
The KXL is a portable system with an articulating arm to allow movement of the system
for alignment of the UV Beam to the patient’s cornea. The treatment parameters(Riboflavin Induction Period, Total UV Energy, UV Power and UV Pulse Cycle Times) areselected through the user interface touch screen computer.
The KXL System is used in conjunction with a Riboflavin solution and an RFID card.

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

Optics Head with UV source and Camera
KXL console with user interface
Wireless remote control (with replaceable batteries)
KXL Accelerated Crosslinking Treatment Kit (disposable supplied
separately)
Hospital Grade AC power cable (Lockable/detachable)
System Part Number: 110-01019

Figure 2-1. Overview Illustration of System

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User
Interface/Console/RFID reader

Figure 2-2. System Illustrations with Callouts

Figure 2-3. Wireless Remote

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Figure 2-4. KXL Label

Figure 2-5. UV emitting Label

Figure 2-6. Laser Classification Label

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

Icon

Description/Function

Power Off button(Initial screen)

Turns OFF electric power tothe console.

Add new patient
button (Initial
screen)Add patient information prior
to treating the patient

Options button(Initial screen)

Displays system settings andmanaging preset plans

Activation cardbalance button

Displays balance on treatment
card

Manage clinic preset
plans

Modify parameters of preset
treatment plan

System Settings

Device settings menu isdisplayed

Service settings

Ability to edit default
parameters

Create newtreatment plan tobegin (Patient
overview screen)

Starts preset or modified
treatment plan for patient

UP arrow(various ClinicalProtocol screens)

Increases the value of thecurrent field.

DOWN arrow(various ClinicalProtocol screens)

Decreases the value of thecurrent field.

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Touchpad Key

Icon

Description/Function

X button(various Device
Settings screens)

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

Checkmark button(various ClinicalProtocol screens andDevice Settings
screen)Directs the system to accept
the current screen entries
and to proceed to the next
step.

Cancel button(various ClinicalProtocol screens andDevice Settings
screen)Cancels all the entries on ascreen and returns to theprevious screen.

Export button

Exports patient treatment
report to USB

Add comment
button (patient
overview screen)

Add notes to a patient
treatment report

Trash Can icon

Delete photos taken during
treatment

Cancel Treatment
button(various ClinicalProtocol screens)

Cancels a treatment session
for a patient.

Start timer button

Starts treatment timer

Change treatment
type button

Changes treatment type

Perform treatment
button(various
Clinical Protocol
screens)

Starts treatment

Touchpad Key

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Return to Treatment
button(Confirm Cancel
Session screen)

Cancels the Cancel Sessioncommand and returns to theTreatment screen.

Return button(various Device
Settings screen)

Returns to the Device
Settings menu.

Restore to factory
presets (manage
clinic preset plans)Presets restored to normal
parameters

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

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3.2 UV Energy (Dose)•The UV Energy (Dose) is the product of the UV Power (Intensity) and the UV
Irradiation Time. The UV Energy and UV Power are adjustable and the calculated
UV Irradiation Time is displayed.

•

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

•

These options are selectable by the user during the treatment plan mode. See
Section 3.8.3•

There are two UV treatment modes available, Continuous and Pulsed.
o Continuous Mode: UV output is constant for the duration of the UV
treatment.
Continuous Mode Parameters:
Induction Period:
1 second – 30 minutes
UV Energy*:
1 – 10.7 J/cm2
UV Power:3 – 45 mW/cm2*The user may select UV Energy in 0.1 J/cm2 increments. The energy
range is controlled by the RFID card.
o Pulsed Mode: UV output turns ON and OFF at user selected intervals.
Pulsed Mode Parameters:
Induction Period:
1 second – 30 minutes
UV Energy*:
1 – 10.7 J/cm2
UV Power:
6 – 45 mW/cm2
UV ON Time:
1.0 – 4.0 Seconds
UV OFF Time:
1.0 – 4.0 Seconds*The user may select UV Energy in 0.1 J/cm2 increments. The energy
range is controlled by the RFID card.

•

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

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3.3 Preparing the System•

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

•

Make sure the system is turned ON.

•

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

•

Check glass window of beam aperture for dust and dirt. See Sections 4.7 and 4.8
for cleaning instructions.

3.4 Important Steps before Turning On the System•

The user is responsible for assuring that the KXL System is functioning properly
before starting a treatment.

•

To ensure the system is functioning properly, consider the following mandatory
points:o Inspect the device, accessories, and connecting cables for visible damage.
o Take local regulations for use of portable electro-optical medical devices
into consideration.

3.5 Powering Up the System•

Turn ON the master power switch on the base of the KXL system, adjacent to thepower cord plug. This switch provides AC mains power to the KXL system.

•

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

Figure 3-1. Power Switch

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

•

Please see section 3.21 for Power Down sequence instructions.

•

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

Figure 3-2. Patient Database

3.6 Existing Patient Data•

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

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3.7 Add New Patient•

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

Figure 3-3. Enter Patient Information•••

If “Use anonymous patient” is selected, last name field will populate asanonymous and an incrementing number will populate in “first name” field.
Once the patient information is completed, the “OK” button will become
available.
Patients can be added at any time and are saved in the database once “OK” ispressed.

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3.8 Create New Treatment Plan•••

Select patient to treat from Patient Database
Press “Create new treatment plan to begin”
Treatment plans can be made and saved prior to patient’s arrival

Figure 3-4. Create New Treatment Plan

3.8.1 Select Eye to Treat••

Choose the eye you wish to treat: OD or OS
When eye is selected, the field will be outlined in blue as shown in Figure 3-5.

Figure 3-5. Select Eye

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3.8.2 Select Treatment Type
•

•
•
•
•

The system is pre-programmed with five preset treatment plans as shown in
Figure 3-6:
o Epi-On Accelerated CXLo Epi-Off Accelerated CXLo Conventional CXLo LASIK Xtra
o CustomSaved formulations and parameters will auto-populate based on the chosen
treatment plan.
Any of the pre-set plans can be edited to change energy dose, irradiance orother treatment parameters then saved for future use.
Select “Custom” treatment plan to create a new, custom plan.
Once a pre-set treatment plan is chosen or a customizable treatment plan issaved, select “Next” to proceed.

Figure 3-6. Select Treatment Type

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3.8.3 Adjusting Treatment Parameters•

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

Figure 3-7. Adjusting Parameters••

When finished editing parameters, select “Save for later treatment” forfuture use, or “Save and perform treatment” for immediate use.
If parameters were adjusted within any of the four presets, “Modified” will be
displayed next to chosen treatment plan, as shown in Figure 3-8.

Figure 3-8. Adjusted Treatment Plan

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

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

•

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

3.9.1 Continuous UV Mode
To select Continuous treatment mode, select “Continuous” from the drop downmenu to the right of “UV Delivery” as shown in Figure 3-9.

Figure 3-9. Select Continuous Treatment Mode•

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

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

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

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3.10 Starting a Treatment••

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

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

Figure 3-11. Insert Activation Card

3.10.2 Single-use Activation Cardso

Keep card in place until read is complete.

Figure 3-12. Reading TagoML-00040

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

KXL Operator’s Manual Rev D | Page 24

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

Figure 3-14. Card Balance: 1 Treatment Remaining

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

Figure 3-15. No Treatments Left

3.10.4RFID Card-controlled Limitso If the user has programmed a UV Energy range that is outside the allowablevalue(s) controlled by the RFID card, the following message will appear after“Perform treatment” has been selected.

Figure 3-16. Invalid Treatment Parameters
o Go Back to Treatment Parameters to enter an appropriate parameter.

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o If the user has the treatment card inserted while programming treatment
parameters that are outside the allowable value(s) controlled by the RFID
card, the following message will appear and “Perform treatment” will unable
to be selected as shown in Figure 3-17.

Figure 3-17. Invalid Treatment Parameters

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

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

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

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

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

Figure 3-21. Remote Indicator Light Status and Meaning

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NOTE: The KXL system performs an internal self-test prior to each treatment toverify 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 eachtreatment. If the internal self-test fails, an error message will be generated andthe treatment cannot proceed. If this occurs, contact your distributor or
Customer Service immediately.

3.11 Preparing the Patient•••

Ensure that the patient is lying flat or reclined on a patient table or chair. His or
her head should rest on a headrest.
Adjust the table or chair and headrest so that the patient can rest comfortably
for the duration of the treatment without head movement.
Apply a lid speculum and optional drapes using standard clinical technique.

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

Figure 3-22. Prepare Treatment: Apply Riboflavin
CAUTION: Riboflavin (vitamin B2) is not a part of the KXL System describedin this manual. For details , please refer to the Riboflavin’s Instructions forUse.
o

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Red alignment lasers will turn on 30 seconds before the end of the Induction
period as shown in Figure 3-23.

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Figure 3-23. Align Crosshairs During Inductiono

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

Red crosshair for X and Y axis positioning.

•

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

Figure 3-24. Alignment of Red Crosshairs – X & Y Axes and Z AxisoML-00040

When alignment lasers turn on, align the crosshairs over the eye to betreated.

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

•

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

•

Fine tune the alignment as needed using the wireless remote or bypressing the onscreen arrows.
NOTE: For correct alignment when using the remote, the Avedro logo on
KXL head should face the user. Figure 3-25 displays the remote functions
to use during the alignment process.

Figure 3-25. Remote Functions

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3.12 Initiating Treatment•

Once the Riboflavin application, Induction, and Alignment of Crosshairs arecomplete, initiate treatment by pressing the “Start UV treatment” button asshown in Figure 3-26.

Figure 3-26. Start UV Treatment•

The patient should fixate on the red X & Y alignment crosshair throughout thetreatment.

•

Patients should remain still during the treatment.

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

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3.13 Monitoring Treatment•

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

Figure 3-27. Treatment in Progress Screen
NOTE: When using Pulsed Treatment mode, UVA light will not be visible during
the OFF periods. The User Interface will not change to “UV is OFF” during thesecycles.

3.14 Pausing a Treatment•

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

•

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

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Figure 3-28. Treatment Paused Screen•

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

3.15 Cancelling Mid-Treatment••

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

Figure 3-29. Confirm Cancel Partial Treatment

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

Figure 3-30. Treatment Cancelled Confirmation••

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

Figure 3-31. Partial Treatment Not Completed

3.16 Capturing Images•

Images can be taken at any stage throughout the treatment process.

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To capture an image, select the camera button in the top right hand corner ofthe eye image as shown in Figure 3-32.
The image is automatically saved and available for review post-treatment.

Figure 3-32. Capturing Images

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3.17 Treatment Complete•

At the completion of a treatment, a summary of treatment parameters will be
displayed, and the screen will show “Treatment complete” as shown in Figure 333.

Figure 3-33. Treatment Complete Screen•••

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

3.18 Reviewing Images••

All images taken throughout treatment are available for review post treatment.
Select “View Photos” to enter the photo gallery as shown in Figure 3-33.

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3.19 Deleting Photos••

Photos taken throughout treatment can be deleted.
In the Photo Gallery, select the trash icon next to the photo to be deleted asshown in Figure 3-34.

Figure 3-34. Select Trash to delete•

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

Figure 3-35. Select Yes to Delete

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

Figure 3-36. Select Done

3.20 Patient Treatment Report
•

•
•
•

A treatment report is generated containing patient information, treatment
details, photos taken throughout treatment, and notes. A sample report isshown in Figure 3-37.
Treatment reports are generated even if treatments are paused or cancelled.
A green checkmark will be listed next to completed phases.
A red “X” mark will be listed next to incomplete phases.

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Figure 3-37. Sample Treatment Report

3.20.1 Adding Notes to a Patient Treatment Reporto From the Patient Database screen, select the patient’s name.
o Press the message icon as shown in Figure 3-38 to enter comments about thepatient’s treatment.

Figure 3-38. Comments Icon
o Keyboard will become available to make comments to the patient’s report.

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Figure 3-39. Comments Section

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

Figure 3-40. Exporting Treatment Report

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

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

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

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

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

Figure 3-44. Treatment report exported

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

Figure 3-45. Page 1 of 3: Treatment Details

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Figure 3-46. Page 2 of 3: Comments

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Figure 3-47. Page 3 of 3: Photos

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3.21 Powering Down the KXL System•

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

Figure 3-48. Select “Power Off”•

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

Figure3-49.

Confirm“Power Off”

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

Figure 3-50. Power Off Position

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

Figure 3-51. Press the “Options” button

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Figure 3-52. System Settings Menu

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

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

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Figure 3-53. Edit System Language

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

Figure 3-54. Alignment Crosshairs Intensity

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

Figure 3-55. Edit Volume

3.22.5 Export Service Log
o Select “Export service log” from the System Settings menu.
o Follow onscreen instructions to insert a USB drive to the USB port as shownin Figure 3-56.

Figure 3-56. Export Service Log to USB

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o The system automatically begins transferring the service log and shows a
progress bar of the transfer process as shown in Figure 3-57.

Figure 3-57. Export Service Log in Progresso Once the export is complete, press the “OK” button to return to the System
Settings menu.

3.22.6 Altering Audible Beep Intervals
o Select “Beep interval” from the System Settings menu to alter the time
between audible beeps while induction is in progress.
o Click the minute and second icons to increase or decrease time, then press
save to return to the System Settings menu.

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Figure 3-58. Select Beep Intervals

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

Figure 3-59. Edit Camera White Balance

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

4.1

Installation Policy••

For each new KXL System customer, an Avedro trained or authorized personnel
provides a full initial installation and start-up of the system. Following initialinstallation and once the system is operating properly, this Avedro
representative may also provide basic training to a designated operator about
the basic operation of the KXL System.
Consequently, this manual does not include any specific instructions relating toinstallation or set-up of the system. Per your service agreement, any further
hardware adjustment, other than what is specified for normal operation, shouldbe performed by, or with the guidance of, an Avedro-authorized distributor.

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

4.3 Warranty Information•

A Warranty is supplied separately with the purchasing information.

4.4 Service Contract Information•

A service contract is available on all KXL Systems. The contract provides forregularly scheduled service and field upgrades. It also provides for any nonscheduled service calls that may be necessary.

4.5 Per Patient Disposables•

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

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4.6 Trouble Shooting•

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

4.6.1 Wireless Remoteo 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 either re-synchronize or “Continue Without
Remote.”Figure 4-1. Alignment Remote Lost Sync
o If light on the remote is flashing two times per second, the remote’s batteries
need to be changed.
o If the light on the remote is flashing once per second, then it is notsynchronized.
o If the remote does not re-synchronize by pressing the “Sync” button, replace
the batteries.
o If replacing the batteries does not allow the system to synchronize, contact
your local Avedro Service Representative.
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4.7 Directions for Disinfection••

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

4.8 Cleaning the System••••

Use a soft damp cloth to clean the KXL System.
The exterior of the System can be cleaned using a lint-free cloth dampened withdilute bleach, soapy water, or isopropyl alcohol.
A 70% isopropyl alcohol or 10% chlorine bleach solution can also be used if
necessary.
DO NOT submerge the System in liquid or pour liquid onto the system.
CAUTION: Power down the system and remove the power supply cord fromthe main outlet prior to any cleaning procedure.
CAUTION: The glass window of the beam aperture must not under any
circumstances be in contact with any aggressive cleaning agents.

••

While cleaning the surfaces of the device, ensure that cleaning fluids do not seep
inside the device, as this leakage can damage the device.
Use a lint-free cloth dampened with isopropyl alcohol to clean the remotecontrol.

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4.9 Cleaning the Aperture••

Check the beam aperture routinely prior to treatment.
Use camera lens wipes or compressed air to remove dust and particles from theglass surface of the aperture.

4.10 Articulating Arm Adjustment•

If the articulating arm does not hold the KXL Head in a fixed vertical position,
contact your local Avedro service representative.

4.11 Moving the System••

The KXL is designed as a movable system within an office environment. If it everproves necessary to transport or ship the KXL System, for any reason, contact
your local Avedro representative. Packing and transporting the system should be
performed only by Avedro trained and authorized personnel.
Prior to moving the KXL System from one room to another, the monitor should
be moved sideways, and the KXL 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 theside
UV optical head nearhandleFigure 4-2. Moving System Configuration

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4.12 Storing the System
•
•
•

•

Follow all the storage temperature and humidity range specifications as listed in
Chapter 7.0 - Specifications.
Close all panels on the system to prevent dust and moisture from entering; this ismandatory.
Turn OFF all the components and switch off the master power switch as well.
Disconnect the power cord from its electrical outlet Remove the batteries fromthe wireless remote.
Do not disassemble any part of the system as this could cause misalignment or
damage.

4.13 Software•

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

4.14 Risks Associated with Disposing of Waste Products•

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

4.15 Performing a Visible Check•

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

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

•
•
•

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

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

According to EN60825-1 Safety of laser productions•

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

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

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

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

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

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

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

CISPR 11
RF emissions
CISPR 11
Harmonic emissions

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

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

IEC 60601

Compliance level

test level
Electrostatic±8 kV contact±8 kV contact

discharge (ESD)±15 kV air±15 kV air±2 kV for power supply
lines±2 kV for power supplylines

IEC 61000-4-4±1 kV for input/output
lines

Not ApplicableSurge±1 kV line(s) to line(s)Input /Output Lines±1 kV line(s) to line(s)IEC 61000-4-5±2 kV line(s) to earth±2 kV line(s) to earth

Voltage dips, shortinterruptions andvoltage variations on
power supply input
lines

0 % UT

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

0% UT

0% UT

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

70% UT

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

0% UT

0% UT

(100 % dip in UT) for 5
sec(100 % dip in UT) for 5
sec

IEC 61000-4-2
Electrical fasttransient/burst

IEC 61000-4-11

Power frequency(50/60 Hz) magnetic
field

30 A/m30 A/mIEC 61000-4-8

Electromagnetic
environment - guidance
Floors should be wood, concrete
or ceramic tile. If floors arecovered with synthetic material,
the relative humidity should be atleast 30%.
Mains power quality should bethat of a typical commercial or
hospital environment.
Mains power quality should bethat of a typical commercial or
hospital environment.

Mains power quality should bethat of a typical commercial or
hospital environment, If the userof the KXL System requires
continued operation during power
mains interruptions, it isrecommended that the KXL System
be powered from anuninterruptible power supply or abattery.

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

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

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

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Immunity test

IEC 60601 testlevel

Compliance
level

Electromagnetic environment — guidancePortable and mobile RF communications equipment
should be used no closer to any part of the KXL
System, including cables, than the recommended
separation distance calculated 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
IEC 61000-4-3

3 V/m
80 MHz to 2.7 GHz

3 Vrms𝑑 = 1,2√𝑃 80 MHz to 800 MHz 𝑑 = 1,2√𝑃

3V/m

𝑑 = 1,2√𝑃 𝑑 = 2,3√𝑃 80 MHz to 2.7 GHz
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 metres (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:

Proximity fields fromRF wirelesscommunications
equipment (IEC
61000-4-3:2006
A1:2007 A2:2010)15 specificfrequencies.

15 specificfrequencies.

Immunity level 928V/m

Immunity level 928V/m

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 andreflection 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 be considered. If the measured field strength in thelocation in which the KXL System is used exceeds the applicable RF compliance level above, the KXL System should be observed toverify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or
relocating the KXL System.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended separation distances between portable and mobile RF communications
equipment and the KXL 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 RFcommunications equipment (transmitters) and the KXL System as recommended below, according to
the maximum output power of the communications equipment.

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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) 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.

The KXL System contains an RFID function which transmits and receives at the 13.56 MHz frequency. Thisfunctionality may be interfered with by other equipment, even if that other equipment complies withCISPR emission requirements.

The KXL System contains the following RF transmitters:

RFID Reader

ML-00040

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•
•
•
•

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

Frequency Modulation

5 GHz (802.11a/n)

2.4 GHz (802.11b/g/n)

Frequency band

5.15 GHz - 5.85 GHz

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

BPSK, QPSK, 16 QAM, 64

CCK, DQPSK, DBPSK

Modulation

QAM
Wireless Medium

Channels

5 GHz UNII: Orthogonal

2.4 GHz ISM: Orthogonal

Frequency Division

Frequency Division

Multiplexing (OFDM)

Multiplexing (OFDM)

4 to 12 (dependent on

Channel 1-11 (US only)

country)

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

ML-00040< 100mW<100mW

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6 Symbol Library
Text Symbol

Symbol Illustration

Definition

1. No AP symbol in presence offlammable anesthetics

Danger, Risk of Explosion. Not
for use

2. AC symbol

Alternating current

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

4. Ground symbol in circle

Protected earth (ground)

5. Ingress Protection Symbol

IP20

6. Power button

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

7. Power Switch

ION

8. Power SwitchOOFF

9. CE Mark

Conformity mark10. Manufacturer

Name and address of the
manufacturer

11. ! in a Triangle

Caution specific warning inoperators manual

12. Net Weight (kgs)
Gross Weight (kgs)
13. Umbrella with raindrops

ML-00040

NW
GW

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

KXL Operator’s Manual Rev D | Page 68

Text Symbol
14. Broken glass

Symbol Illustration
orDefinition
Contents are fragile, handle withcare

15. Two up arrows

Keep arrows on carton pointingup

16. Water drop in a box

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

17. Operating Temperature
limitsOperating Temperature limits

18. Storage Temperature limits

Storage Temperature limits

19. MR crossed in a circle

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

20. Storage Pressure limits

Storage Atmospheric pressure
limits

21. Operating Pressure limits

Operating Atmospheric pressure
limits

22. Signal emitted

RF transmitted through device

ML-00040

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7 Specifications
Specification

Description

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

List of cables and Accessories

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

Energy Delivery

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

UV Radiation
365 nmExternal Interfaces

USB 2.0

Physical Dimensions

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

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

Ambient temperature
Relative humidity
Atmospheric pressure

ML-00040

FCC ID: SXJ87027-TX
2.405-2.475 GHz.
The system operates under the following
atmospheric conditions (no condensation).
+15 to +30 ºC
20% to 80% , non-condensing
810 to 1050 mbar
The instrument withstands the following
transport and storage conditions without
damage or performance deterioration.
-15 to +60 ºC
10% to 80% non-condensing
750 to 1060 mbar